[House Prints 111-B]
[From the U.S. Government Publishing Office]
111th Congress Committee
2nd Session COMMITTEE PRINT Print 111-B
_______________________________________________________________________
COMPILATION OF SELECTED ACTS WITHIN
THE JURISDICTION OF THE COMMITTEE
ON ENERGY AND COMMERCE
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HEALTH LAW
Public Health Service Act
As Amended Through January 2, 2011
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prepared for the use of the
COMMITTEE ON ENERGY AND COMMERCE
U.S. HOUSE OF REPRESENTATIVES
111th Congress Committee
2nd Session COMMITTEE PRINT Print 111-B
_______________________________________________________________________
COMPILATION OF SELECTED ACTS WITHIN
THE JURISDICTION OF THE COMMITTEE
ON ENERGY AND COMMERCE
__________
HEALTH LAW
Public Health Service Act
As Amended Through January 2, 2011
__________
prepared for the use of the
COMMITTEE ON ENERGY AND COMMERCE
U.S. HOUSE OF REPRESENTATIVES
U.S. GOVERNMENT PRINTING OFFICE
63-169 WASHINGTON : 2011
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee ED WHITFIELD, Kentucky
BOBBY L. RUSH, Illinois JOHN SHIMKUS, Illinois
ANNA G. ESHOO, California JOHN B. SHADEGG, Arizona
BART STUPAK, Michigan ROY BLUNT, Missouri
ELIOT L. ENGEL, New York Deputy Ranking Member
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MIKE DOYLE, Pennsylvania LEE TERRY, Nebraska
JANE HARMAN, California MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina PARKER GRIFFITH, Alabama
CHARLIE MELANCON, Louisiana ROBERT E. LATTA, Ohio
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
Philip S. Barnett, Staff Director
Kristin L. Amerling, Chief Counsel
David L. Cavicke, Minority Chief of Staff
(ii)
For changes after the closing date of this publication
(January 2, 2011) to provisions of law in this publication, see
the United States Code Classification Tables published by the
Office of the Law Revision Counsel of the House of
Representatives at
http://uscode.house.gov/classification/tables.shtml.
(iii)
COMPILATION OF SELECTED ACTS -- HEALTH LAW
======================================================================
PUBLIC HEALTH SERVICE ACT
======================================================================
NOTE.--Reorganization Plan No. 3 of 1966 transferred all
statutory powers and functions of the Surgeon General and other
officers of the Public Health Service and of all agencies of or
in the Service to the Secretary of Health, Education, and
Welfare. The Department of Education Organization Act
designated the Secretary of Health, Education, and Welfare as
the Secretary of Health and Human Services. References in the
Act to the Surgeon General, other officers of the Service, the
Secretary of Health, Education, and Welfare, and the Department
of Health, Education, and Welfare, should be read in the light
of the transfer of statutory functions and the redesignation.
START OF STATUTE deg.STATUTE NAME= deg.PUBLIC HEALTH
SERVICE ACT
[As Amended Through P.L. ___ (H.R. 847), Enacted January 2, 2011]
(References in brackets [ ] are to title 42, United States Code)
TITLE I--SHORT TITLE AND DEFINITIONS
short title
Section 1. [201 note] This Act may be cited as the ``Public
Health Service Act''.
definitions
Sec. 2. [201] When used in this Act--
(a) The term ``Service'' means the Public Health Service;
(b) The term ``Surgeon General'' means the Surgeon General
of the Public Health Service;
(c) Unless the context otherwise requires, the term
``Secretary'' means the Secretary of Health and Human Services;
(d) The term ``regulations'', except when otherwise
specified, means rules and regulations made by the Surgeon
General with the approval of the Secretary;
(e) The term ``executive department'' means any executive
department, agency, or independent establishment of the United
States or any corporation wholly owned by the United States;
(f) Except as provided in sections 314(g)(4)(B), 318(c)(1),
331(h)(3), 335(5), 361(d), 701(9), 1002(c), 1401(13), 1531(1),
and 1633(1), the term ``State'' includes, in addition to the
several States, only the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the
Virgin Islands, American Samoa, and the Trust Territory of the
Pacific Islands.
(g) The term ``possession'' includes, among other
possessions, Puerto Rico and the Virgin Islands;
(h) [Repealed.]
(i) The term ``vessel'' includes every description of
watercraft or other artificial contrivance used, or capable of
being used, as a means of transportation on water, exclusive of
aircraft and amphibious contrivances;
(j) The term ``habit-forming narcotic drug'' or
``narcotic'' means opium and coca leaves and the several
alkaloids derived therefrom, the best known of these alkaloids
being morphia, heroin, and codeine, obtained from opium, and
cocaine derived from the coca plant; all compounds, salts,
preparations, or other derivatives obtained either from the raw
material or from the various alkaloids; Indian hemp and its
various derivatives, compounds, and preparations, and peyote in
its various forms; isonipecaine and its derivatives, compounds,
salts and preparations; opiates (as defined in section 3228(f)
of the Internal Revenue Code);
(k) The term ``addict'' means any person who habitually
uses any habit-forming narcotic drugs so as to endanger the
public morals, health, safety, or welfare, or who is or has
been so far addicted to the use of such habit-forming narcotic
drugs as to have lost the power of self-control with reference
to his addiction;
(l) The term ``psychiatric disorders'' includes diseases of
the nervous system which affect mental health;
(m) The term ``State mental health authority'' means the
State health authority, except that, in the case of any State
in which there is a single State agency, other than the State
health authority, charged with responsibility for administering
the mental health program of the State, it means such other
State agency;
(n) The term ``heart diseases'' means diseases of the heart
and circulation;
(o) The term ``dental diseases and conditions'' means
diseases and conditions affecting teeth and their supporting
structures, and other related diseases of the mouth;
(p) The term ``uniformed service'' means the Army, Navy,
Air Force, Marine Corps, Coast Guard, Public Health Service, or
Coast and Geodetic Survey; and
(q) The term ``drug dependent person'' means a person who
is using a controlled substance (as defined in section 102 of
the Controlled Substances Act) and who is in a state of psychic
or physical dependence, or both, arising from the use of that
substance on a continuous basis. Drug dependence is
characterized by behavioral and other responses which include a
strong compulsion to take the substance on a continuous basis
in order to experience its psychic effects or to avoid the
discomfort caused by its absence.
TITLE II--ADMINISTRATION AND MISCELLANEOUS PROVISIONS
Part A--Administration
public health service
Sec. 201. [202] The Public Health Service in the Department
of Health and Human Services shall be administered by the
Assistant Secretary for Health under the supervision and
direction of the Secretary.
organization
Sec. 202. \1\ [203] The Service shall consist of (1) the
Office of the Surgeon General, (2) the National Institutes of
Health, (3) the Bureau of Medical Services, and (4) the Bureau
of State Services, and the Agency for Health Care Policy and
Research. \2\ The Secretary is authorized and directed to
assign to the Office of the Secretary, to the National
Institutes of Health, to the Bureau of Medical Services, and to
the Bureau of State Services, respectively, the several
functions of the Service, and to establish within them such
divisions, sections and other units as he may find necessary;
and from time to time, abolish, transfer, and consolidate
divisions, sections, and other units and assign their functions
and personnel in such manner as he may find necessary for
efficient operation of the Service. No division shall be
established, abolished, or transferred, and no divisions shall
be consolidated, except with the approval of the Secretary. The
National Institutes of Health shall be administered as a part
of the field service. The Secretary may delegate to any officer
or employee of the Service such of his powers and duties under
this Act, except the making of regulations, as he may deem
necessary or expedient.
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\1\ The organizational units specified in this section, other than
the Agency for Health Care Policy and Research, were all abolished as
statutory entities by Reorganization Plan No. 3 of 1966. Although the
Reorganization Plan abolished the National Institutes of Health as an
agency, it did not abolish the individual research institutes.
In 1985, Public Law 99-158 added title IV of this Act, which
provides that the National Institutes of Health is an agency of the
Public Health Service. See section 401(a).
Other laws have established additional agencies within the
Service. Section 501(a) of this Act provides that the Substance Abuse
and Mental Health Services Administration is an agency of the Service.
Section 901(a) establishes the Agency for Healthcare Research and
Quality within the Service (formerly designated as the Agency for
Health Care Policy and Research).
Although not established in this Act, the Centers for Disease
Control and Prevention, the Health Resources and Services
Administration, and the Agency for Toxic Substances and Disease
Registry are agencies of the Service.
The Food and Drug Administration is also an agency of the
Service.
\2\ So in law. See section 2008(g)(2) of Public Law 103-43 (107
Stat. 212). The term ``the Agency'' probably should be preceded by
``(5)'', and the ``and'' before ``(4)'' probably should be struck.
Further, Public Law 106-129 redesignated the Agency for Health Care
Policy and Research as the Agency for Healthcare Research and Quality
(see 113 Stat. 1653).
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SEC. 203. [204] COMMISSIONED CORPS AND READY RESERVE CORPS.
(a) Establishment.--
(1) In general.--There shall be in the Service a
commissioned Regular Corps and a Ready Reserve Corps
for service in time of national emergency.
(2) Requirement.--All commissioned officers shall
be citizens of the United States and shall be appointed
without regard to the civil-service laws and
compensated without regard to the Classification Act of
1923, \1\ as amended.
---------------------------------------------------------------------------
\1\ Civil service and classification laws are now codified to title
5, United States Code.
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(3) Appointment.--Commissioned officers of the
Ready Reserve Corps shall be appointed by the President
and commissioned officers of the Regular Corps shall be
appointed by the President with the advice and consent
of the Senate.
(4) Active duty.--Commissioned officers of the
Ready Reserve Corps shall at all times be subject to
call to active duty by the Surgeon General, including
active duty for the purpose of training.
(5) Warrant officers.--Warrant officers may be
appointed to the Service for the purpose of providing
support to the health and delivery systems maintained
by the Service and any warrant officer appointed to the
Service shall be considered for purposes of this Act
and title 37, United States Code, to be a commissioned
officer within the Commissioned Corps of the Service.
(b) Assimilating Reserve Corp Officers Into the Regular
Corps.--Effective on the date of enactment of the Patient
Protection and Affordable Care Act, all individuals classified
as officers in the Reserve Corps under this section (as such
section existed on the day before the date of enactment of such
Act) and serving on active duty shall be deemed to be
commissioned officers of the Regular Corps.
(c) Purpose and Use of Ready Research.--
(1) Purpose.--The purpose of the Ready Reserve
Corps is to fulfill the need to have additional
Commissioned Corps personnel available on short notice
(similar to the uniformed service's reserve program) to
assist regular Commissioned Corps personnel to meet
both routine public health and emergency response
missions.
(2) Uses.--The Ready Reserve Corps shall--
(A) participate in routine training to meet
the general and specific needs of the
Commissioned Corps;
(B) be available and ready for involuntary
calls to active duty during national
emergencies and public health crises, similar
to the uniformed service reserve personnel;
(C) be available for backfilling critical
positions left vacant during deployment of
active duty Commissioned Corps members, as well
as for deployment to respond to public health
emergencies, both foreign and domestic; and
(D) be available for service assignment in
isolated, hardship, and medically underserved
communities (as defined in section 799B) to
improve access to health services.
(d) Funding.--For the purpose of carrying out the duties
and responsibilities of the Commissioned Corps under this
section, there are authorized to be appropriated $5,000,000 for
each of fiscal years 2010 through 2014 for recruitment and
training and $12,500,000 for each of fiscal years 2010 through
2014 for the Ready Reserve Corps.
SEC. 203A. [204A] DEPLOYMENT READINESS.
(a) Readiness Requirements for Commissioned Corps
Officers.--
(1) In general.--The Secretary, with respect to
members of the following Corps components, shall
establish requirements, including training and medical
examinations, to ensure the readiness of such
components to respond to urgent or emergency public
health care needs that cannot otherwise be met at the
Federal, State, and local levels:
(A) Active duty Regular Corps.
(B) Active Reserves.
(2) Annual assessment of members.--The Secretary
shall annually determine whether each member of the
Corps meets the applicable readiness requirements
established under paragraph (1).
(3) Failure to meet requirements.--A member of the
Corps who fails to meet or maintain the readiness
requirements established under paragraph (1) or who
fails to comply with orders to respond to an urgent or
emergency public health care need shall, except as
provided in paragraph (4), in accordance with
procedures established by the Secretary, be subject to
disciplinary action as prescribed by the Secretary.
(4) Waiver of requirements.--
(A) In general.--The Secretary may waive
one or more of the requirements established
under paragraph (1) for an individual who is
not able to meet such requirements because of--
(i) a disability;
(ii) a temporary medical condition;
or
(iii) any other extraordinary
limitation as determined by the
Secretary.
(B) Regulations.--The Secretary shall
promulgate regulations under which a waiver
described in subparagraph (A) may be granted.
(5) Urgent or emergency public health care need.--
For purposes of this section and section 214, the term
``urgent or emergency public health care need'' means a
health care need, as determined by the Secretary,
arising as the result of--
(A) a national emergency declared by the
President under the National Emergencies Act
(50 U.S.C. 1601 et seq.);
(B) an emergency or major disaster declared
by the President under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act
(42 U.S.C. 5121 et seq.);
(C) a public health emergency declared by
the Secretary under section 319 of this Act; or
(D) any emergency that, in the judgment of
the Secretary, is appropriate for the
deployment of members of the Corps.
(b) Corps Management for Deployment.--The Secretary shall--
(1) organize members of the Corps into units for
rapid deployment by the Secretary to respond to urgent
or emergency public health care needs;
(2) establish appropriate procedures for the
command and control of units or individual members of
the Corps that are deployed at the direction of the
President or the Secretary in response to an urgent or
emergency public health care need of national, State or
local significance;
(3) ensure that members of the Corps are trained,
equipped and otherwise prepared to fulfill their public
health and emergency response roles; and
(4) ensure that deployment planning takes into
account--
(A) any deployment exemptions that may be
granted by the Secretary based on the unique
requirements of an agency and an individual's
functional role in such agency; and
(B) the nature of the urgent or emergency
public health care need.
(c) Deployment of Detailed or Assigned Officers.--For
purposes of pay, allowances, and benefits of a Commissioned
Corps officer who is detailed or assigned to a Federal entity,
the deployment of such officer by the Secretary in response to
an urgent or emergency public health care need shall be deemed
to be an authorized activity of the Federal entity to which the
officer is detailed or assigned.
surgeon general
Sec. 204. [205] The Surgeon General shall be appointed from
the Regular Corps for a four-year term by the President by and
with the advice and consent of the Senate. The Surgeon General
shall be appointed from individuals who (1) are members of the
Regular Corps, and (2) have specialized training or significant
experience in public health programs. Upon the expiration of
such term, the Surgeon General, unless reappointed, shall
revert to the grade and number in the Regular or Reserve Corps
that he would have occupied had he not served as Surgeon
General.
deputy surgeon general and assistant surgeons general
Sec. 205. [206] (a) The Surgeon General shall assign one
commissioned officer from the Regular Corps to administer the
Office of the Surgeon General, to act as Surgeon General during
the absence or disability of the Surgeon General or in the
event of a vacancy in that office, and to perform such other
duties as the Surgeon General may prescribe, and while so
assigned he shall have the title of Deputy Surgeon General.
(b) The Surgeon General shall assign eight commissioned
officers from the Regular Corps to be, respectively, the
Director of the National Institutes of Health, the Chief of the
Bureau of State Services, the Chief of the Bureau of Medical
Services, the Chief Medical Officer of the United States Coast
Guard, the Chief Dental Officer of the Service, the Chief Nurse
Officer of the Service, the Chief Pharmacist Officer of the
Service, and the Chief Sanitary Engineering Officer of the
Service, and while so serving they shall each have the title of
Assistant Surgeon General.
(c)(1) The Surgeon General, with the approval of the
Secretary, is authorized to create special temporary positions
in the grade of Assistant Surgeons General when necessary for
the proper staffing of the Service. The Surgeon General may
assign officers of either the Regular Corps or the Reserve
Corps to any such temporary position, and while so serving they
shall each have the title of Assistant Surgeon General.
(2) Except as provided in this paragraph, the number of
special temporary positions created by the Surgeon General
under paragraph (1) shall not on any day exceed 1 per centum of
the highest number, during the ninety days preceding such day,
of officers of the Regular Corps on active duty and officers of
the Reserve Corps on active duty for more than thirty days. If
on any day the number of such special temporary positions
exceeds such 1 per centum limitations, for a period of not more
than one year after such day, the number of such special
temporary positions shall be reduced for purposes of complying
with such 1 per centum limitation only by the resignation,
retirement, death, or transfer to a position of a lower grade,
of any officer holding any such temporary position.
(d) The Surgeon General shall designate the Assistant
Surgeon General who shall serve as Surgeon General in case of
absence or disability, or vacancy in the offices, of both the
Surgeon General and the Deputy Surgeon General.
grades, ranks, and titles of the commissioned corps
Sec. 206. [207] (a) The Surgeon General during the period
of his appointment as such, shall be of the same grade as the
Surgeon General of the army; the Deputy Surgeon General and the
Chief Medical Officer of the United States Coast Guard, while
assigned as such, shall have the grade corresponding with the
grade of major general; and the Chief Dental Officer, while
assigned as such, shall have the grade as is prescribed by law
for the officer of the Dental Corps selected and appointed as
Assistant Surgeon General of the Army. During the period of
appointment to the position of Assistant Secretary for Health,
a commissioned officer of the Public Health Service shall have
the grade corresponding to the grade of General of the Army.
Assistant Surgeons General, while assigned as such, shall have
the grade corresponding with either the grade of brigadier
general or the grade of major general, as may be determined by
the Secretary after considering the importance of the duties to
be performed: Provided, That the number of Assistant Surgeons
General having a grade higher than that corresponding to the
grade of brigadier general shall at no time exceed one-half of
the number of positions created by subsection (b) of section
205 or pursuant to subsection (c) of such section. The grades
of commissioned officers of the Service shall correspond with
grades of officers of the Army as follows:
(1) Officers of the director grade--colonel;
(2) Officers of the senior grade--lieutenant
colonel;
(3) Officers of the full grade--major;
(4) Officers of the senior assistant grade--
captain;
(5) Officers of the assistant grade--first
lieutenant;
(6) Officers of the junior assistant grade--second
lieutenant;
(7) Chief warrant officers of (W-4) grade--chief
warrant officer (W-4);
(8) Chief warrant officers of (W-3) grade--chief
warrant officer (W-3);
(9) Chief warrant officers of (W-2) grade--chief
warrant officer (W-2); and
(10) Warrant officers of (W-1) grade--warrant
officer (W-1).
(b) The titles of medical officers of the foregoing grades
shall be respectively (1) medical director, (2) senior surgeon,
(3) surgeon, (4) senior assistant surgeon, (5) assistant
surgeon and (6) junior assistant surgeon.
(c) The President is authorized to prescribe titles,
appropriate to the several grades, for commissioned officers of
the Service other than medical officers. All titles of the
officers of the Reserve Corps shall have the suffix
``Reserve''.
(d) Within the total number of officers of the Regular
Corps authorized by the appropriation Act or Acts for each
fiscal year to be on active duty, the Secretary shall by
regulation prescribe the maximum number of officers authorized
to be in each of the grades from the warrant officer (W-1)
grade to the director grade, inclusive. Such numbers shall be
determined after considering the anticipated needs of the
Service during the fiscal year, the funds available, the number
of officers in each grade at the beginning of the fiscal year,
and the anticipated appointments, the anticipated promotions
based on years of service, and the anticipated retirements
during the fiscal year. The number so determined for any grade
for a fiscal year may not exceed the number limitation (if any)
contained in the appropriation Act or Acts for such year. Such
regulations for each fiscal year shall be prescribed as
promptly as possible after the appropriation Act fixing the
authorized strength of the corps for that year, and shall be
subject to amendment only if such authorized strength or such
number limitation is thereafter changed. The maxima established
by such regulations shall not require (apart from action
pursuant to other provisions of this Act) any officer to be
separated from the Service or reduced in grade.
(e) In computing the maximum number of commissioned
officers of the Public Health Service authorized by law to hold
a grade which corresponds to the grade of brigadier general or
major general, there may be excluded from such computation not
more than three officers who hold such a grade so long as such
officers are assigned to duty and are serving in a policymaking
position in the Department of Defense.
(f) In computing the maximum number of commissioned
officers of the Public Health Service authorized by law or
administrative determination to serve on active duty, there may
be excluded from such computation officers who are assigned to
duty in the Department of Defense.
appointment of personnel
Sec. 207. [209] (a)(1) Except as provided in subsections
(b) and (e) of this section, original appointments to the
Regular Corps may be made only in the warrant officer (W-1),
chief warrant officer (W-2), chief warrant officer (W-3), chief
warrant officer (W-4), junior assistant, assistant, and senior
assistant grades and original appointments to a grade above
junior assistant shall be made only after passage of an
examination, given in accordance with regulations of the
President, in one or more of the several branches of medicine,
dentistry, hygiene, sanitary engineering, pharmacy, psychology,
nursing, or related scientific specialties in the field of
public health.
(2) Original appointments to the Reserve Corps may be made
to any grade up to and including the director grade but only
after passage of an examination given in accordance with
regulations of the President. Reserve commissions shall be for
an indefinite period and may be terminated at any time, as the
President may direct.
(3) No individual who has attained the age of forty-four
shall be appointed to the Regular Corps, or called to active
duty in the Reserve Corps for a period in excess of one year,
unless (A) he has had a number of years of active service (as
defined in section 211(d)) equal to the number of years by
which his age exceeds forty-four, or (B) the Surgeon General
determines that he possesses exceptional qualifications, not
readily available elsewhere in the Commissioned Corps of the
Public Health Service, for the performance of special duties
with the Service, or (C) in the case of an officer of the
Reserve Corps, the Commissioned Corps of the Service has been
declared by the President to be a military service.
(b)(1) Not more than 10 per centum of the original
appointments to the Regular Corps authorized to be made during
any fiscal year may be made to grades above that of senior
assistant, but no such appointment (other than an appointment
under section 204) may be made to a grade above that of
director. For the purpose of this subsection the number of
original appointments authorized to be made during a fiscal
year shall be (1) the excess of the number of officers of the
Regular Corps authorized by the appropriation Act or Acts for
such year over the number of officers on active duty in the
Regular Corps on the first day of such year, plus (2) the
number of such officers of the Regular Corps who, during such
fiscal year, have been or will be retired upon attainment of
age sixty-four or have for any other reason ceased to be on
active duty. In determining the number of appointments
authorized by this subsection an appointment shall be deemed to
be made in the fiscal year in which the nomination is
transmitted by the President to the Senate.
(2) In addition to the number of original appointments to
the Regular Corps authorized by paragraph (1) to be made to
grades above that of senior assistant, original appointments
authorized to be made to the Regular Corps in any year may be
made to grades above that of senior assistant, but not above
that of director, in the case of any individual who--
(A)(i) was on active duty in the Regular Corps on
July 1, 1960, (ii) was on such active duty continuously
for not less than one year immediately prior to such
date, and (iii) applies for appointment to the Regular
Corps prior to July 1, 1962; or
(B) does not come within clause (A)(i) and (ii) but
was on active duty in the Reserve Corps continuously
for not less than one year immediately prior to his
appointment to the Regular Corps and has not served on
active duty continuously for a period, occurring after
June 30, 1960, of more than three and one-half years
prior to applying for such appointment.
(3) No person shall be appointed pursuant to this
subsection unless he meets standards established in accordance
with regulations of the President.
(c) Commissions evidencing the appointment by the President
of officers of the Regular or Reserve Corps shall be issued by
the Secretary under the seal of the Department of Health,
Education, and Welfare.
(d)(1) For purposes of basic pay and for purposes of
promotion, any person appointed under subsection (a) to the
grade of senior assistant in the Regular Corps and any person
appointed under subsection (b), shall, except as provided in
paragraphs (2) and (3) of this subsection, be considered as
having had on the date of appointment the following length of
service: Three years if appointed to the senior assistant
grade, ten years if appointed to the full grade, seventeen
years if appointed to the senior grade, and eighteen years if
appointed to the director grade.
(2) For purposes of basic pay, any person appointed under
subsection (a) to the grade of senior assistant in the Regular
Corps, and any person appointed under subsection (b), shall, in
lieu of the credit provided in paragraph (1), be credited with
the service for which he is entitled to credit under any other
provision of law if such service exceeds that to which he would
be entitled under such paragraph.
(3) For purposes of promotion, any person originally
appointed in the Regular Corps to the senior assistant grade or
above who has had active service in the Reserve Corps shall be
considered as having had on the date of appointment the length
of service provided for in paragraph (1), plus whichever of the
following is greater: (A) The excess of his total active
service in the Reserve Corps (above the grade of junior
assistant) over the length of service provided in such
paragraph, to the extent that such excess is on account of
service in the Reserve Corps in or above the grade to which he
is appointed in the Regular Corps or (B) his active service in
the same or any higher grade in the Reserve Corps after the
first day on which, under regulations in effect on the date of
his appointment to the Regular Corps, he would have had the
training and experience necessary for such appointment.
(4) For purposes of promotion, any person whose original
appointment is to the assistant grade in the Regular Corps
shall be considered as having had on the date of appointment
service equal to his total active service in the Reserve Corps
in and above the assistant grade.
(e)(1) A former officer of the Regular Corps may, if
application for appointment is made within two years after the
date of the termination of his prior commission in the Regular
Corps, be reappointed to the Regular Corps without examination,
except as the Surgeon General may otherwise prescribe, and
without regard to the numerical limitations of subsection (b).
(2) Reappointments pursuant to this subsection may be made
to the permanent grade held by the former officer at the time
of the termination of his prior commission, or to the next
higher grade if such officer meets the eligibility requirements
prescribed by regulation for original appointment to such
higher grade. For purposes of pay, promotion, and seniority in
grade, such reappointed officer shall receive the credits for
service to which he would be entitled if such appointment were
an original appointment, but in no event less than the credits
he held at the time his prior commission was terminated, except
that if such officer is reappointed to the next higher grade he
shall receive no credit for seniority in grade.
(3) No former officer shall be reappointed pursuant to this
subsection unless he shall meet such standards as the Secretary
may prescribe.
(f) In accordance with regulations, special consultants may
be employed to assist and advise in the operations of the
Service. Such consultants may be appointed without regard to
the civil-service laws and their compensation may be fixed
without regard to the Classification Act of 1923, as amended.
\1\
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\1\ See footnote for the second sentence of section 203.
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(g) In accordance with regulations, individual scientists,
other than commissioned officers of the Service, may be
designated by the Surgeon General to receive fellowships,
appointed for duty with the Service without regard to the
civil-service laws and compensated without regard to the
Classification Act of 1923, as amended, \1\ may hold their
fellowships under conditions prescribed therein, and may be
assigned for studies or investigations either in this country
or abroad during the terms of their fellowships.
(h) Persons who are not citizens may be employed as
consultants pursuant to subsection (e) and may be appointed to
fellowships pursuant to subsection (f). Unless otherwise
specifically provided, any prohibition in any other Act against
the employment of aliens, or against the payment of
compensation to them, shall not be applicable in the case of
persons employed or appointed pursuant to such subsections.
(i) The appointment of any officer or employee of the
Service made in accordance with the civil-service laws shall be
made by the Secretary, and may be made effective as of the date
on which such officer or employee enters upon duty.
pay and allowances
Sec. 208. [210] (a)(1) Commissioned officers of the Regular
and Reserve Corps shall be entitled to receive such pay and
allowances as are now or may hereafter be authorized by law.
(2) For provisions relating to the receipt of special pay
by commissioned officers of the Regular and Reserve Corps while
on active duty, see section 303a(b) of title 37, United States
Code.
(b) Commissioned officers on active duty, and retired
officers entitled to retired pay pursuant to section 210(g)(3),
section 211 or section 221(a), shall be permitted to purchase
supplies from the Army, Navy, Air Force, and Marine Corps at
the same price as is charged officers thereof.
(c) Members of the National Advisory Health Council and
members of other national advisory or review councils or
committees established under this Act, including members of the
Technical Electronic Product Radiation Safety Standards
Committee and the Board of Regents of the National Library of
Medicine, but excluding ex officio members, while attending
conferences or meetings of their respective councils or
committees or while otherwise serving at the request of the
Secretary shall be entitled to receive compensation at rates to
be fixed by the Secretary, but at rates not exceeding the daily
equivalent of the rate specified at the time of such service
for grade GS-18 of the General Schedule, including traveltime;
and while away from their homes or regular places of business
they may be allowed travel expenses, including per diem in lieu
of subsistence, as authorized by section 5703 of title 5 of the
United States Code for persons in the Government service
employed intermittently.
(d) Field employees of the Service, except those employed
on a per diem or fee basis, who render part-time duty and are
also subject to call at any time for services not contemplated
in their regular part-time employment, may be paid annual
compensation for such part-time duty and, in addition, such
fees for such other services as the Surgeon General may
determine; but in no case shall the total paid to any such
employee for any fiscal year exceed the amount of the minimum
annual salary rate of the classification grade of the employee.
(e) Any civilian employee of the Service who is employed at
the Gillis W. Long Hansen's Disease Center on the date of the
enactment of the Consolidated Omnibus Budget Reconciliation Act
of 1985 shall be entitled to receive, in addition to any
compensation to which the employee may otherwise be entitled
and for so long as the employee remains employed at the Center,
an amount equal to one-fourth of such compensation.
(f) Individuals appointed under subsection (g) shall have
included in their fellowships such stipends or allowances,
including travel and subsistence expenses, as the Surgeon
General may deem necessary to procure qualified fellows.
(g) The Secretary is authorized to establish and fix the
compensation for, within the Public Health Service, not more
than one hundred and seventy-nine positions, of which not less
than one hundred and fifteen shall be for the National
Institutes of Health, not less than five shall be for the
National Institute on Alcohol Abuse and Alcoholism for
individuals engaged in research on alcohol and alcoholism, not
less than ten shall be for the National Center for Health
Services Research, not less than twelve shall be for the
National Center for Health Statistics, and not less than seven
shall be for the National Center for Health Care Technology, in
the professional, scientific, and executive service, each such
position being established to effectuate those research and
development activities of the Public Health Service which
require the services of specially qualified scientific,
professional, and administrative personnel: Provided, That the
rates of compensation for positions established pursuant to the
provisions of this subsection shall not be less than the
minimum rate of grade 16 of the General Schedule of the
Classification Act of 1949, as amended, \1\ nor more than (1)
the highest rate of grade 18 of the General Schedule of such
Act, or (2) in the case of two such positions, the rate
specified, at the time the service in the position is
performed, for level II of the Executive Schedule (5 U.S.C.
5313); and such rates of compensation for all positions
included in this proviso shall be subject to the approval of
the Civil Service Commission. Positions created pursuant to
this subsection shall be included in the classified civil
service of the United States, but appointments to such
positions shall be made without competitive examination upon
approval of the proposed appointee's qualifications by the
Civil Service Commission or such officers or agents as it may
designate for this purpose.
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\1\ See footnote for the second sentence of section 203.
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professional categories
Sec. 209. [210b] (a) For the purpose of establishing
eligibility of officers of the Regular Corps for promotions,
the Surgeon General shall by regulation divide the corps into
professional categories. Each category shall, as far as
practicable, be based upon one of the subjects of examination
set forth in section 207(a)(1) or upon a subdivision of such
subject, and the categories shall be designed to group officers
by fields of training in such manner that officers in any one
grade in any one category will be available for similar duty in
the discharge of the several functions of the Service.
(b) Each officer of the Regular Corps on active duty shall,
on the basis of his training and experience, be assigned by the
Surgeon General to one of the categories established by
regulations under subsection (a). Except upon amendment of such
regulations, no assignment so made shall be changed unless the
Surgeon General finds (1) that the original assignment was
erroneous, or (2) that the officer is equally well qualified to
serve in another category to which he has requested to be
transferred, and that such transfer is in the interests of the
Service.
(c) Within the limits fixed by the Secretary in regulations
under section 206(d) for any fiscal year, the Surgeon General
shall determine for each category in the Regular Corps the
maximum number of officers authorized to be in each of the
grades from the warrant officer (W-1) grade to the director
grade, inclusive.
(d) The excess of the number so fixed for any grade in any
category over the number of officers of the Regular Corps on
active duty in such grade in such category (including, in the
case of the director grade, officers holding such grade in
accordance with section 206(c)) shall for the purpose of
promotions constitute vacancies in such grade in such category.
For purposes of this subsection, an officer who has been
temporarily promoted or who is temporarily holding the grade of
director in accordance with section 206(c) shall be deemed to
hold the grade to which so promoted or which he is temporarily
holding; but while he holds such promotion or grade, and while
any officer is temporarily assigned to a position pursuant to
section 205(c), the number fixed under subsection (c) of this
section for the grade of his permanent rank shall be reduced by
one.
(e) The absence of a vacancy in a grade in a category shall
not prevent an appointment to such grade pursuant to section
207, a permanent length of service promotion, or the recall of
a retired officer to active duty; but the making of such an
appointment, promotion, or recall shall be deemed to fill a
vacancy if one exists.
(f) Whenever a vacancy exists in any grade in a category
the Surgeon General may increase by one the number fixed by him
under subsection (c) for the next lower grade in the same
category, without regard to the numbers fixed in regulations
under section 206(d); and in that event the vacancy in the
higher grade shall not be filled except by a permanent
promotion, and upon the making of such promotion the number for
the next lower grade shall be reduced by one.
promotions and separation of commissioned officers in the regular corps
Sec. 210. [211] (a) Promotions of officers of the Regular
Corps to any grade up to and including the director grade shall
be either permanent promotions based on length of service,
other permanent promotions to fill vacancies, or temporary
promotions. Permanent promotions shall be made by the
President, by and with the advice and consent of the Senate,
and temporary promotions shall be made by the President. Each
permanent promotion shall be to the next higher grade, and
shall be made only after examination given in accordance with
regulations of the President.
(b) The President may by regulation provide that in a
specified professional category permanent promotions to the
senior grade, or to both the full grade and the senior grade,
shall be made only if there are vacancies in such grade. A
grade in any category with respect to which such regulations
have been issued is referred to in this section as a
``restricted grade''.
(c) Examinations to determine qualification for permanent
promotions may be either noncompetitive or competitive, as the
Surgeon General shall in each case determine; except that
examinations for promotions to the assistant or senior
assistant grade shall in all cases be noncompetitive. The
officers to be examined shall be selected by the Surgeon
General from the professional category, and in the order of
seniority in the grade, from which promotion is to be
recommended. In the case of a competitive examination the
Surgeon General shall determine in advance of the examination
the number (which may be one or more) of officers who, after
passing the examination, will be recommended to the President
for promotion; but if the examination is one for promotions
based on length of service, or is one for promotions to fill
vacancies other than vacancies in the director grade or in a
restricted grade, such number shall not be less than 80 per
centum of the number of officers to be examined.
(d) Officers of the Regular Corps, found pursuant to
subsection (c) to be qualified, shall be given permanent
promotions based on length of service, as follows:
(1) Officers in the warrant officer (W-1) grade, chief
warrant officer (W-2) grade, chief warrant officer (W-3) grade,
chief warrant officer (W-4) grade, and junior assistant grade
shall be promoted at such times as may be prescribed in
regulations of the President.
(2) Officers with permanent rank in the assistant grade,
the senior assistant grade, and the full grade shall (except as
provided in regulations under subsection (b)) be promoted after
completion of three, ten, and seventeen years, respectively, of
service in grades above the junior assistant grade; and such
promotions, when made, shall be effective, for purposes of pay
and seniority in grade, as of the day following the completion
of such years of service. An officer with permanent rank in the
assistant, senior assistant, or full grade who has not
completed such years of service shall be promoted at the same
time, and his promotion shall be effective as of the same day,
as any officer junior to him in the same grade in the same
professional category who is promoted under this paragraph.
(e) Officers in a professional category of the Regular
Corps, found pursuant to subsection (c) to be qualified may be
given permanent promotions to fill any or all vacancies in such
category in the senior assistant grade, the full grade, the
senior grade, or the director grade; but no officer who has not
had one year of service with permanent or temporary rank in the
next lower grade shall be promoted to any restricted grade or
to the director grade.
(f) If an officer who has completed the years of service
required for promotion to a grade under paragraph (2) of
subsection (d) fails to receive such promotion, he shall
(unless he has already been twice examined for promotion to
such grade) be once reexamined for promotion to such grade. If
he is thereupon promoted (otherwise than under subsection (e)),
the effective date of such promotion shall be one year later
than it would have been but for such failure. Upon the
effective date of any permanent promotion of such officer to
such grade, he shall be considered as having had only the
length of service required for such promotion which he
previously failed to receive.
(g) If, for reasons other than physical disability, an
officer of the Regular Corps in the warrant officer (W-1) grade
or junior assistant grade is found pursuant to subsection (c)
not to be qualified for promotion he shall be separated from
the Service. If, for reasons other than physical disability, an
officer of the Regular Corps in the chief warrant officer (W-
2), chief warrant officer (W-3), assistant, senior assistant,
or full grade, after having been twice examined for promotion
(other than promotion to a restricted grade), fails to be
promoted--
(1) if in the chief warrant officer (W-2) or
assistant grade he shall be separated from the Service
and paid six months' basic pay and allowances;
(2) if in the chief warrant officer (W-3) or senior
assistant grade he shall be separated from the Service
and paid one year's basic pay and allowances;
(3) if in the full grade he shall be considered as
not in line for promotion and shall, at such time
thereafter as the Surgeon General may determine, be
retired from the Service with retired pay (unless he is
entitled to a greater amount by reason of another
provision of law)--
(A) in the case of an officer who first
became a member of a uniformed service before
September 8, 1980, at the rate of 2\1/2\
percent of the retired pay base determined
under section 1406(h) of title 10, United
States Code, for each year, not in excess of
30, of his active commissioned service in the
Service; or
(B) in the case of an officer who first
became a member of a uniformed service on or
after September 8, 1980, at the rate determined
by multiplying--
(i) the retired pay base determined
under section 1407 of title 10, United
States Code; by
(ii) the retired pay multiplier
determined under section 1409 of such
title for the number of years of his
active commissioned service in the
Service.
(h) If an officer of the Regular Corps, eligible to take an
examination for promotion, refuses to take such examination, he
may be separated from the Service in accordance with
regulations of the President.
(i) At the end of his first three years of service, the
record of each officer of the Regular Corps, originally
appointed to the senior assistant grade or above, shall be
reviewed in accordance with regulations of the President and,
if found not qualified for further service, he shall be
separated from the Service and paid six months' pay and
allowances.
(j)(1) The order of seniority of officers in a grade in the
Regular Corps shall be determined, subject to the provisions of
paragraph (2), by the relative length of time spent in active
service after the effective date of each such officer's
original appointment or permanent promotion in that grade. When
permanent promotions of two or more officers to the same grade
are effective on the same day, their relative seniority shall
be the same as it was in the grade from which promoted. In all
other cases of original appointments or permanent promotions
(or both) to the same grade effective on the same day, relative
seniority shall be determined in accordance with regulations of
the President.
(2) In the case of an officer originally appointed in the
Regular Corps to the grade of assistant or above, his seniority
in the grade to which appointed shall be determined after
inclusion, as service in such grade, of any active service in
such grade or in any higher grade in the Reserve Corps, but (if
the appointment is to the grade of senior assistant or above)
only to the extent of whichever of the following is greater:
(A) His active service in such grade or any higher grade in the
Reserve Corps after the first day on which, under regulations
in effect on the date of his appointment to the Regular Corps,
he had the training and experience necessary for such
appointment, or (B) the excess of his total active service in
the Reserve Corps (above the grade of junior assistant) over
three years if his appointment in the Regular Corps is to the
senior assistant grade, over ten years if the appointment is to
the full grade, or over seventeen years if the appointment is
to the senior grade.
(k) Any commissioned officer of the Regular Corps in any
grade in any professional category may be recommended to the
President for temporary promotion to fill a vacancy in any
higher grade in such category, up to and including the director
grade. In time of war, or of national emergency proclaimed by
the President, any commissioned officer of the Regular Corps in
any grade in any professional category may be recommended to
the President for promotion to any higher grade in such
category, up to and including the director grade, whether or
not a vacancy exists in such grade. The selection of officers
to be recommended for temporary promotions shall be made in
accordance with regulations of the President. Promotion of an
officer recommended pursuant to this subsection may be made
without regard to length of service, without examination, and
without vacating his permanent appointment, and shall carry
with it the pay and allowances of the grade to which promoted.
Such promotions may be terminated at any time, as may be
directed by the President.
(l) Whenever the number of officers of the Regular Corps on
active duty, plus the number of officers of the Reserve Corps
who have been on active duty for thirty days or more, exceeds
the authorized strength of the Regular Corps, the Secretary
shall determine the requirements of the Service in each grade
in each category, based upon the total number of officers so
serving on active duty and the tasks being performed by the
Service; and the Surgeon General shall thereupon assign each
officer of the Reserve Corps on active duty to a professional
category. If the Secretary finds that the number of officers
fixed under section 209(c) for any grade and category (or the
number of officers, including officers of the Reserve Corps, on
active duty in such grade in such category, if such number is
greater than the number fixed under section 209(c)) is
insufficient to meet such requirements of the Service, officers
of either the Regular Corps or the Reserve Corps may be
recommended for temporary promotion to such grade in such
category. Any such promotion may be terminated at any time, as
may be directed by the President.
(m) Any officer of the Regular Corps, or any officer of the
Reserve Corps on active duty, who is promoted to a higher grade
shall, unless he expressly declines such promotion, be deemed
for all purposes to have accepted such promotion; and shall not
be required to renew his oath of office, or to execute a new
affidavit as required by the Act of December 11, 1926, as
amended (5 U.S.C. 21a). \1\
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\1\ That Act has been codified to section 3332 of title 5, United
States Code.
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retirement of commissioned officers
Sec. 211. [212] (a)(1) A commissioned officer of the
Service shall, if he applies for retirement, be retired on or
after the first day of the month following the month in which
he attains the age of sixty-four years. This paragraph does not
permit or require the involuntary retirement of any individual
because of the age of the individual.
(2) A commissioned officer of the Service may be retired by
the Secretary, and shall be retired if he applies for
retirement, on the first day of any month after completion of
thirty years of active service.
(3) Any commissioned officer of the Service who has had
less than thirty years of active service may be retired by the
Secretary, with or without application by the officer, on the
first day of any month after completion of twenty or more years
of active service of which not less than ten are years of
active commissioned service in any of the uniformed services.
(4) Except as provided in paragraph (6), a commissioned
officer retired pursuant to paragraph (1), (2), or (3) who was
(in the case of an officer in the Reserve Corps) on active duty
with the Service on the day preceding such retirement shall be
entitled to receive retired pay at the rate of 2\1/2\ per
centum of the basic pay of the highest grade held by him as
such officer and in which, in the case of a temporary promotion
to such grade, he has performed active duty for not less than
six months, (A) for each year of active service, or (B) if it
results in higher retired pay, for each of the following years:
(i) his years of active service (determined without
regard to subsection (d)) as a member of a uniformed
service; plus
(ii) in the case of a medical or dental officer,
four years and, in the case of a medical officer, who
has completed one year of medical internship or the
equivalent thereof, one additional year, the four years
and the one year to be reduced by the period of active
service performed during such officer's attendance at
medical school or dental school or during his medical
internship; plus
(iii) the number of years of service with which he
was entitled to be credited for purposes of basic pay
on May 31, 1958, or (if higher) on any date prior
thereto, reduced by any such year included under clause
(i) and further reduced by any such year with which he
was entitled to be credited under paragraphs (7) and
(8) of section 205(a) of title 37, United States Code,
on any date before June 1, 1958;
except that (C) in the case of any officer whose retired pay,
so computed, is less than 50 per centum of such basic pay, who
retires pursuant to paragraph (1) of this subsection, who has
not less than twelve whole years of active service (computed
without the application of subsection (e)), and who does not
use, for purposes of a retirement annuity under the Civil
Service Retirement Act, \1\ any service which is also
creditable in computing his retired pay from the Service, it
shall, instead, be 50 per centum of such pay, and (D) the
retired pay of an officer shall in no case be more than 75 per
centum of such basic pay.
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\1\ The Civil Service Retirement Act has been codified to chapter
83 of title 5, United States Code.
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(5) With the approval of the President, a commissioned
officer whose service as Surgeon General, Deputy Surgeon
General, or Assistant Surgeon General has totaled four years or
more and who has had not less than twenty-five years of active
service in the Service may retire voluntarily at any time; and
except as provided in paragraph (6), his retired pay shall be
at the rate of 75 per centum of the basic pay of the highest
grade held by him as such officer.
(6) The retired pay of a commissioned officer retired under
this subsection who first became a member of a uniformed
service after September 7, 1980, is determined by multiplying--
(A) the retired pay base determined under section
1407 of title 10, United States Code; by
(B) the retired pay multiplier determined under
section 1409 of such title for the number of years of
service credited to the officer under paragraph (4).
(7) Retired pay computed under section 210(g)(3) or under
paragraph (4) or (5) of this subsection, if not a multiple of
$1, shall be rounded to the next lower multiple of $1.
(b) For purposes of subsection (a), the basic pay of the
highest grade to which a commissioned officer has received a
temporary promotion means the basic pay to which he would be
entitled if serving on active duty in such grade on the date of
his retirement.
(c) A commissioned officer, retired for reasons other than
for failure of promotion to the senior grade, may (1) if an
officer of the Regular Corps or an officer of the Reserve Corps
entitled to retired pay under subsection (a), be involuntarily
recalled to active duty during such times as the Commissioned
Corps constitutes a branch of the land or naval forces of the
United States, and (2) if an officer of either the Regular or
Reserve Corps, be recalled to active duty at any time with his
consent.
(d) The term ``active service'', as used in subsection (a),
includes:
(1) all active service in any of the uniformed
services;
(2) active service with the Public Health Service,
other than as a commissioned officer, which the Surgeon
General determines is comparable to service performed
by commissioned officers of the Service, except that,
if there are more than five years of such service only
the last five years thereof may be included;
(3) all active service (other than service included
under the preceding provisions of this subsection)
which is creditable for retirement purposes under laws
governing the retirement of members of any of the
uniformed services; and
(4) service performed as a member of the Senior
Biomedical Research Service established by section 228,
except that, if there are more than 5 years of such
service, only the last 5 years thereof may be included.
(e) For the purpose of determining the number of years by
which a percentage of the basic pay of an officer is to be
multiplied in computing the amount of his retired pay pursuant
to section 210(g)(3) or paragraph (4) of subsection (a) of this
section, each full month of service that is in addition to the
number of full years of service credited to an officer is
counted as one-twelfth of a year and any remaining fractional
part of a month is disregarded.
(f) For purposes of retirement or separation for physical
disability under chapter 61 of title 10, United States Code, a
commissioned officer of the Service shall be credited, in
addition to the service described in section 1208(a)(2) of that
title, with active service with the Public Health Service,
other than as a commissioned officer, which the Surgeon General
determines is comparable to service performed by commissioned
officers of the Service, except that, if there are more than
five years of such service, only the last five years thereof
may be so credited. For such purposes, such section 1208(a)(2)
shall be applicable to officers of the Regular or Reserve Corps
of the Service.
military benefits
Sec. 212. [213] (a) Except as provided in subsection (b),
commissioned officers of the Service and their surviving
beneficiaries shall, with respect to active service performed
by such officers--
(1) in time of war;
(2) on detail for duty with the Army, Navy, Air
Force, Marine Corps, or Coast Guard; or
(3) while the Service is part of the military
forces of the United States pursuant to Executive order
of the President;
be entitled to all rights, privileges, immunities, and benefits
now or hereafter provided under any law of the United States in
the case of commissioned officers of the Army or their
surviving beneficiaries on account of active military service,
except retired pay and uniform allowances.
(b) The President may prescribe the conditions under which
commissioned officers of the Service may be awarded military
ribbons, medals, and decorations.
(c) The authority vested by law in the Department of the
Army, the Secretary of the Army, or other officers of the
Department of the Army with respect to rights, privileges,
immunities, and benefits referred to in subsection (a) shall be
exercised, with respect to commissioned officers of the
Service, by the Surgeon General.
(d) Active service of commissioned officers of the Service
shall be deemed to be active military service in the Armed
Forces of the United States for the purposes of all laws
administered by the Secretary of Veterans Affairs (except the
Servicemen's Indemnity Act of 1951) and section 217 of the
Social Security Act.
(e) Active service of commissioned officers of the Service
shall be deemed to be active military service in the Armed
Forces of the United States for the purposes of all rights,
privileges, immunities, and benefits now or hereafter provided
under the Servicemembers Civil Relief Act (50 App. U.S.C. 501
et seq.).
(f) Active service of commissioned officers of the Service
shall be deemed to be active military service in the Armed
Forces of the United States for purposes of all laws related to
discrimination on the basis of race, color, sex, ethnicity,
age, religion, and disability.
presentation of united states flag upon retirement
Sec. 213. [214] (a) Presentation of Flag.--Upon the release
of an officer of the commissioned corps of the Service from
active commissioned service for retirement, the Secretary of
Health and Human Services shall present a United States flag to
the officer.
(b) Multiple Presentations Not Authorized.--An officer is
not eligible for presentation of a flag under subsection (a) if
the officer has previously been presented a flag under this
section or any other provision of law providing for the
presentation of a United States flag incident to release from
active service for retirement.
(c) No Cost to Recipient.--The presentation of a flag under
this section shall be at no cost to the recipient.
detail of personnel
Sec. 214. \1\ [215] (a) The Secretary is authorized, upon
the request of the head of an executive department, to detail
officers or employees of the Service to such department for
duty as agreed upon by the Secretary and the head of such
department in order to cooperate in, or conduct work related
to, the functions of such department or of the Service. When
officers or employees are so detailed their salaries and
allowances may be paid from working funds established as
provided by law or may be paid by the Service from applicable
appropriation and reimbursement may be made as agreed upon by
the Secretary and the head of the executive department
concerned. Officers detailed for duty with the Army, Navy, or
Coast Guard shall be subject to the laws for the government of
the service to which detailed.
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\1\ Former section 213 was repealed by section 14 of Public Law 87-
649 (76 Stat. 499). Section 415(c) of title 37, United States Code, now
applies to the matter with which former section 213 was concerned.
---------------------------------------------------------------------------
(b) Upon the request of any State health authority or, in
the case of work relating to mental health, any State mental
health authority, personnel of the Service may be detailed by
the Surgeon General for the purpose of assisting such State or
political subdivision thereof in work related to the functions
of the Service.
(c) The Surgeon General may detail personnel of the Service
to any appropriate committee of the Congress or to nonprofit
educational research or other institutions engaged in health
activities for special studies of scientific problems and for
the dissemination of information relating to public health.
(d) Personnel detailed under subsections (b) and (c) shall
be paid from applicable appropriations of the Service except
that, in accordance with regulations such personnel may be
placed on leave without pay and paid by the State, subdivision,
or institution to which they are detailed. In the case of
detail of personnel under subsections (b) or (c) to be paid
from applicable Service appropriations, the Secretary may
condition such detail on an agreement by the State,
subdivision, or institution concerned that such State,
subdivision, or institution concerned shall reimburse the
United States for the amount of such payments made by the
Service. The services of personnel while detailed pursuant to
this section shall be considered as having been performed in
the Service for purposes of the computation of basic pay,
promotion, retirement, compensation for injury or death, and
the benefits provided by section 212.
(e) Except with respect to the United States Coast Guard
and the Department of Defense, and except as provided in
agreements negotiated with officials at agencies where officers
of the Commissioned Corps may be assigned, the Secretary shall
have the sole authority to deploy any Commissioned Corps
officer assigned under this section to an entity outside of the
Department of Health and Human Services for service under the
Secretary's direction in response to an urgent or emergency
public health care need (as defined in section 203A(a)(5)).
regulations
Sec. 215. [216] (a) The President shall from time to time
prescribe regulations with respect to the appointment,
promotion, retirement, termination of commission, title, pay,
uniforms, allowances (including increased allowances for
foreign service), and discipline of the commissioned corps of
the Service.
(b) The Surgeon General, with the approval of the
Secretary, unless specifically otherwise provided, shall
promulgate all other regulations necessary to the
administration of the Service, including regulations with
respect to uniforms for employees, and regulations with respect
to the custody, use, and preservation of the records, papers,
and property of the Service.
(c) No regulations relating to qualifications for
appointment of medical officers or employees shall give
preference to any school of medicine.
use of service in time of war or emergency
Sec. 216. [217] In time of war, or of emergency proclaimed
by the President, he may utilize the Service to such extent and
in such manner as shall in his judgment promote the public
interest. In time of war, or of emergency involving the
national defense proclaimed by the President, he may by
Executive order declare the commissioned corps of the Service
to be a military service. Upon such declaration, and during the
period of such war or such emergency or such part thereof as
the President shall prescribe, the commissioned corps (a) shall
constitute a branch of the land and naval forces of the United
States, (b) shall, to the extent prescribed by regulations of
the President, be subject to the Uniform Code of Military
Justice, and (c) shall continue to operate as part of the
Service except to the extent that the President may direct as
Commander in Chief.
national advisory councils
Sec. 217. [218] (a) Within 120 days of the date of the
enactment of this subsection, the Secretary shall appoint and
organize a National Advisory Council on Migrant Health
(hereinafter in this subsection referred to as the Council)
which shall advise, consult with, and make recommendations to,
the Secretary on matters concerning the organization,
operation, selection, and funding of migrant health centers and
other entities under grants and contracts under section 329.
\1\
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\1\ As a result of the amendments made by Public Law 104-299 (110
Stat. 3626), the Public Health Service Act no longer contained a
section 329, 340, or 340A, and section 330 of such Act was
substantially revised. Section 330 now includes provisions that relate
to medically underserved populations, to migratory and seasonal
agricultural workers, to homeless individuals, and to residents of
public housing. Section 402 of Public Law 107-251 (116 Stat. 1655)
added a new section 340 that relates to a healthy communities access
program.
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(b) The Council shall consist of fifteen members, at least
twelve of whom shall be members of the governing boards of
migrant health centers or other entities assisted under section
329. \1\ Of such twelve members who are members of such
governing boards, at least nine shall be chosen from among
those members of such governing boards who are being served by
such centers or grantees and who are familiar with the delivery
of health care to migratory agricultural workers and seasonal
agricultural workers. The remaining three Council members shall
be individuals qualified by training and experience in the
medical sciences or in the administration of health programs.
(c) Each member of the Council shall hold office for a term
of four years, except that (1) any member appointed to fill a
vacancy occurring prior to the expiration of the term for which
his predecessor was appointed shall be appointed for the
remainder of such term; and (2) the terms of the members first
taking office after the date of enactment of this subsection
shall expire as follows: four shall expire four years after
such date, four shall expire three years after such date, four
shall expire two years after such date, and three shall expire
one year after such date, as designated by the Secretary at the
time of appointment.
(d) Section 14(a) of the Federal Advisory Committee Act
shall not apply to the Council.
training of officers
Sec. 218. [218a] (a) Appropriations available for the pay
and allowances of commissioned officers of the Service shall
also be available for the pay and allowances of any such
officer on active duty while attending any Federal or non-
Federal educational institution or training program and,
subject to regulations of the President and to the limitation
prescribed in such appropriations, for payment of his tuition,
fees, and other necessary expenses incident to such attendance.
(b) Any officer whose tuition, fees, and other necessary
expenses are paid pursuant to subsection (a) while attending an
educational institution or training program for a period in
excess of thirty days shall be obligated to pay to the Service
an amount equal to two times the total amount of such tuition,
fees, and other necessary expenses received by such officer
during such period, and two times the total amount of any
compensation received by, and any allowance paid to, such
officer during such period, if after return to active service
such officer voluntarily leaves the Service within (1) six
months, or (2) twice the period of such attendance, whichever
is greater. Such subsequent period of service shall commence
upon the cessation of such attendance and of any further
continuous period of training duty for which no tuition and
fees are paid by the Service and which is part of the officer's
prescribed formal training program, whether such further
training is at Service facility or otherwise. The Surgeon
General may waive, in whole or in part, any payment which may
be required by this subsection upon a determination that such
payment would be inequitable or would not be in public
interest.
(c) A commissioned officer may be placed in leave without
pay status while attending an educational institution or
training program whenever the Secretary determines that such
status is in the best interest of the Service. For purposes of
computation of basic pay, promotion, retirement, compensation
for injury or death, and the benefits provided by sections 212
and 224, an officer in such status pursuant to the preceding
sentence shall be considered as performing service in the
Service and shall have an active service obligation as set
forth in subsection (b) of this section.
annual and sick leave
Sec. 219. [210-1] (a) In accordance with regulations of the
President, commissioned officers of the Regular Corps and
officers of the Reserve Corps on active duty may be granted
annual leave and sick leave without any deductions from their
pay and allowances: Provided, That such regulations shall not
authorize annual leave to be accumulated in excess of sixty
days.
(d) \1\ For purposes of this section the term ``accumulated
annual leave'' means unused accrued annual leave carried
forward from one leave year into a succeeding leave year, and
the term ``accrued annual leave'' means the annual leave
accruing to an officer during one leave year.
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\1\ Former subsection (b) was repealed by section 14 of Public Law
87-649 (76 Stat. 499). Section 503(b) of title 37, United States Code,
now applies to the matter with which former subsection (b) was
concerned. Former subsection (c) was repealed by section 311 of Public
Law 96-76 (93 Stat. 586).
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promotion credit--assistant grade
Sec. 220. [211c] Any medical officer of the Regular Corps
of the Public Health Service who--
(1)(A) was appointed to the assistant grade in the
Regular Corps and whose service in such Corps has been
continuous from the date of appointment or (B) may
hereafter be appointed to the assistant grade in the
Regular Corps, and
(2) had or will have completed a medical internship
on the date of such appointment,
shall be credited with one year for purposes of promotion and
seniority in grade, except that no such credit shall be
authorized if the officer has received or will receive similar
credit for his internship under other provisions of law. In the
case of an officer on active duty on the effective date of this
section who is entitled to the credit authorized herein, the
one year shall be added to the promotion and seniority-in-grade
credits with which he is credited on such date.
rights, privileges, etc. of officers and surviving beneficiaries
Sec. 221. [213a] (a) Commissioned officers of the Service
or their surviving beneficiaries are entitled to all the
rights, benefits, privileges, and immunities now or hereafter
provided for commissioned officers of the Army or their
surviving beneficiaries under the following provisions of title
10, United States Code:
(1) Section 1036, Escorts for dependents of
members: transportation and travel allowances.
(2) Chapter 61, Retirement or Separation for
Physical Disability, except that sections 1201, 1202,
and 1203 do not apply to commissioned officers of the
Public Health Service who have been ordered to active
duty for training for a period of more than 30 days.
(3) Chapter 69, Retired Grade, except sections
1370, 1374, 1375, and 1376(a).
(4) Chapter 71, Computation of Retired Pay, except
formula No. 3 of section 1401.
(5) Chapter 73, Retired Serviceman's Family
Protection Plan, Survivor Benefit Plan.
(6) Chapter 75, Death Benefits.
(7) Section 2771, Final settlement of accounts:
deceased members.
(8) Chapter 163, Military Claims, but only when
commissioned officers of the Service are entitled to
military benefits under section 212 of this Act.
(9) Section 2603, Acceptance of fellowships,
scholarships, or grants.
(10) Section 2634 Motor vehicles: for members on
permanent change of station.
(11) Section 1035, Deposit of savings.
(12) Section 1552, Correction of military records:
claims incident thereto.
(13) Section 1553, Review of discharge or
dismissal.
(14) Section 1554, Review of retirement or
separation without pay for physical disability.
(15) Section 1124, Cash awards for suggestions,
inventions, or scientific achievements.
(16) Section 1052, Reimbursement for adoption
expenses.
(17) Section 1059, Transitional compensation and
commissary and exchange benefits for dependents of
members separated for dependent abuse.
(b) The authority vested by title 10, United States Code,
in the ``military departments'', ``the Secretary concerned'',
or ``the Secretary of Defense'' with respect to the rights,
privileges, immunities, and benefits referred to in subsection
(a) shall be exercised, with respect to commissioned officers
of the Service, by the Secretary of Health, Education, and
Welfare or his designee.
advisory councils or committees
Sec. 222. [217a] (a) The Secretary may, without regard to
the provisions of title 5, United States Code, governing
appointments in the competitive service, and without regard to
the provisions of chapter 51 and subchapter III of chapter 53
of such title relating to classification and General Schedule
pay rates, from time to time, appoint such advisory councils or
committees (in addition to those authorized to be established
under other provisions of law), for such periods of time, as he
deems desirable with such period commencing on a date specified
by the Secretary for the purpose of advising him in connection
with any of his functions.
(b) Members of any advisory council or committee appointed
under this section who are not regular full-time employees of
the United States shall, while attending meetings or
conferences of such council or committee or otherwise engaged
on business of such council or committee receive compensation
and allowances as provided in section 208(c) for members of
national advisory councils established under this Act.
(c) Upon appointment of any such council or committee, the
Secretary may delegate to such council or committee such
advisory functions relating to grants-in-aid for research or
training projects or programs, in the areas or fields with
which such council or committee is concerned, as the Secretary
determines to be appropriate.
volunteer services
Sec. 223. [217b] Subject to regulations, volunteer and
uncompensated services may be accepted by the Secretary, or by
any other officer or employee of the Department of Health and
Human Services designated by him, for use in the operation of
any health care facility or in the provision of health care.
defense of certain malpractice and negligence suits
Sec. 224. [233] (a) The remedy against the United States
provided by sections 1346(b) and 2672 of title 28, or by
alternative benefits provided by the United States where the
availability of such benefits precludes a remedy under section
1346(b) of title 28, for damage for personal injury, including
death, resulting from the performance of medical, surgical,
dental, or related functions, including the conduct of clinical
studies or investigation, by any commissioned officer or
employee of the Public Health Service while acting within the
scope of his office or employment, shall be exclusive of any
other civil action or proceeding by reason of the same subject-
matter against the officer or employee (or his estate) whose
act or omission gave rise to the claim.
(b) The Attorney General shall defend any civil action or
proceeding brought in any court against any person referred to
in subsection (a) of this section (or his estate) for any such
damage or injury. Any such person against whom such civil
action or proceeding is brought shall deliver within such time
after date of service or knowledge of service as determined by
the Attorney General, all process served upon him or an
attested true copy thereof to his immediate superior or to
whomever was designated by the Secretary to receive such papers
and such persons shall promptly furnish copies of the pleading
and process therein to the United States attorney for the
district embracing the place wherein the proceeding is brought,
to the Attorney General, and to the Secretary.
(c) Upon a certification by the Attorney General that the
defendant was acting in the scope of his employment at the time
of the incident out of which the suit arose, any such civil
action or proceeding commenced in a State court shall be
removed without bond at any time before trial by the Attorney
General to the district court of the United States of the
district and division embracing the place wherein it is pending
and the proceeding deemed a tort action brought against the
United States under the provisions of title 28 and all
references thereto. Should a United States district court
determine on a hearing on a motion to remand held before a
trial on the merit that the case so removed is one in which a
remedy by suit within the meaning of subsection (a) of this
section is not available against the United States, the case
shall be remanded to the State Court: Provided, That where such
a remedy is precluded because of the availability of a remedy
through proceedings for compensation or other benefits from the
United States as provided by any other law, the case shall be
dismissed, but in the event the running of any limitation of
time for commencing, or filing an application or claim in, such
proceedings for compensation or other benefits shall be deemed
to have been suspended during the pendency of the civil action
or proceeding under this section.
(d) The Attorney General may compromise or settle any claim
asserted in such civil action or proceeding in the manner
provided in section 2677 of title 28 and with the same effect.
(e) For purposes of this section, the provisions of section
2680(h) of title 28 shall not apply to assault or battery
arising out of negligence in the performance of medical,
surgical, dental, or related functions, including the conduct
of clinical studies or investigations.
(f) The Secretary or his designee may, to the extent that
he deems appropriate, hold harmless or provide liability
insurance for any officer or employee of the Public Health
Service for damage for personal injury, including death,
negligently caused by such officer or employee while acting
within the scope of his office or employment and as a result of
the performance of medical, surgical, dental, or related
functions, including the conduct of clinical studies or
investigations, if such employee is assigned to a foreign
country or detailed to a State or political subdivision thereof
or to a non-profit institution, and if the circumstances are
such as are likely to preclude the remedies of third persons
against the United States described in section 2679(b) of title
28, for such damage or injury.
(g)(1)(A) For purposes of this section and subject to the
approval by the Secretary of an application under subparagraph
(D), an entity described in paragraph (4), and any officer,
governing board member, or employee of such an entity, and any
contractor of such an entity who is a physician or other
licensed or certified health care practitioner (subject to
paragraph (5)), shall be deemed to be an employee of the Public
Health Service for a calendar year that begins during a fiscal
year for which a transfer was made under subsection (k)(3)
(subject to paragraph (3)). The remedy against the United
States for an entity described in paragraph (4) and any
officer, governing board member, employee, or contractor
(subject to paragraph (5)) of such an entity who is deemed to
be an employee of the Public Health Service pursuant to this
paragraph shall be exclusive of any other civil action or
proceeding to the same extent as the remedy against the United
States is exclusive pursuant to subsection (a).
(B) The deeming of any entity or officer, governing board
member, employee, or contractor of the entity to be an employee
of the Public Health Service for purposes of this section shall
apply with respect to services provided--
(i) to all patients of the entity, and
(ii) subject to subparagraph (C), to individuals
who are not patients of the entity.
(C) Subparagraph (B)(ii) applies to services provided to
individuals who are not patients of an entity if the Secretary
determines, after reviewing an application submitted under
subparagraph (D), that the provision of the services to such
individuals--
(i) benefits patients of the entity and general
populations that could be served by the entity through
community-wide intervention efforts within the
communities served by such entity;
(ii) facilitates the provision of services to
patients of the entity; or
(iii) are otherwise required under an employment
contract (or similar arrangement) between the entity
and an officer, governing board member, employee, or
contractor of the entity.
(D) The Secretary may not under subparagraph (A) deem an
entity or an officer, governing board member, employee, or
contractor of the entity to be an employee of the Public Health
Service for purposes of this section, and may not apply such
deeming to services described in subparagraph (B)(ii), unless
the entity has submitted an application for such deeming to the
Secretary in such form and such manner as the Secretary shall
prescribe. The application shall contain detailed information,
along with supporting documentation, to verify that the entity,
and the officer, governing board member, employee, or
contractor of the entity, as the case may be, meets the
requirements of subparagraphs (B) and (C) of this paragraph and
that the entity meets the requirements of paragraphs (1)
through (4) of subsection (h).
(E) The Secretary shall make a determination of whether an
entity or an officer, governing board member, employee, or
contractor of the entity is deemed to be an employee of the
Public Health Service for purposes of this section within 30
days after the receipt of an application under subparagraph
(D). The determination of the Secretary that an entity or an
officer, governing board member, employee, or contractor of the
entity is deemed to be an employee of the Public Health Service
for purposes of this section shall apply for the period
specified by the Secretary under subparagraph (A).
(F) Once the Secretary makes a determination that an entity
or an officer, governing board member, employee, or contractor
of an entity is deemed to be an employee of the Public Health
Service for purposes of this section, the determination shall
be final and binding upon the Secretary and the Attorney
General and other parties to any civil action or proceeding.
Except as provided in subsection (i), the Secretary and the
Attorney General may not determine that the provision of
services which are the subject of such a determination are not
covered under this section.
(G) In the case of an entity described in paragraph (4)
that has not submitted an application under subparagraph (D):
(i) The Secretary may not consider the entity in
making estimates under subsection (k)(1).
(ii) This section does not affect any authority of
the entity to purchase medical malpractice liability
insurance coverage with Federal funds provided to the
entity under section 329, 330, or 340A.
(H) In the case of an entity described in paragraph (4) for
which an application under subparagraph (D) is in effect, the
entity may, through notifying the Secretary in writing, elect
to terminate the applicability of this subsection to the
entity. With respect to such election by the entity:
(i) The election is effective upon the expiration
of the 30-day period beginning on the date on which the
entity submits such notification.
(ii) Upon taking effect, the election terminates
the applicability of this subsection to the entity and
each officer, governing board member, employee, and
contractor of the entity.
(iii) Upon the effective date for the election,
clauses (i) and (ii) of subparagraph (G) apply to the
entity to the same extent and in the same manner as
such clauses apply to an entity that has not submitted
an application under subparagraph (D).
(iv) If after making the election the entity
submits an application under subparagraph (D), the
election does not preclude the Secretary from approving
the application (and \1\ thereby restoring the
applicability of this subsection to the entity and each
officer, governing board member, employee, and
contractor of the entity, subject to the provisions of
this subsection and the subsequent provisions of this
section.
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\1\ So in law. See section 5(a) of Public Law 104-73 (109 Stat.
779). There is no closing parenthesis.
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(2) If, with respect to an entity or person deemed to be an
employee for purposes of paragraph (1), a cause of action is
instituted against the United States pursuant to this section,
any claim of the entity or person for benefits under an
insurance policy with respect to medical malpractice relating
to such cause of action shall be subrogated to the United
States.
(3) This subsection shall apply with respect to a cause of
action arising from an act or omission which occurs on or after
January 1, 1993.
(4) An entity described in this paragraph is a public or
non-profit private entity receiving Federal funds under section
330.
(5) For purposes of paragraph (1), an individual may be
considered a contractor of an entity described in paragraph (4)
only if--
(A) the individual normally performs on average at
least 32\1/2\ hours of service per week for the entity
for the period of the contract; or
(B) in the case of an individual who normally
performs an average of less than 32\1/2\ hours of
services per week for the entity for the period of the
contract, the individual is a licensed or certified
provider of services in the fields of family practice,
general internal medicine, general pediatrics, or
obstetrics and gynecology.
(h) The Secretary may not approve an application under
subsection (g)(1)(D) unless the Secretary determines that the
entity--
(1) has implemented appropriate policies and
procedures to reduce the risk of malpractice and the
risk of lawsuits arising out of any health or health-
related functions performed by the entity;
(2) has reviewed and verified the professional
credentials, references, claims history, fitness,
professional review organization findings, and license
status of its physicians and other licensed or
certified health care practitioners, and, where
necessary, has obtained the permission from these
individuals to gain access to this information;
(3) has no history of claims having been filed
against the United States as a result of the
application of this section to the entity or its
officers, employees, or contractors as provided for
under this section, or, if such a history exists, has
fully cooperated with the Attorney General in defending
against any such claims and either has taken, or will
take, any necessary corrective steps to assure against
such claims in the future; and
(4) will fully cooperate with the Attorney General
in providing information relating to an estimate
described under subsection (k).
(i)(1) Notwithstanding subsection (g)(1), the Attorney
General, in consultation with the Secretary, may on the record
determine, after notice and opportunity for a full and fair
hearing, that an individual physician or other licensed or
certified health care practitioner who is an officer, employee,
or contractor of an entity described in subsection (g)(4) shall
not be deemed to be an employee of the Public Health Service
for purposes of this section, if treating such individual as
such an employee would expose the Government to an unreasonably
high degree of risk of loss because such individual--
(A) does not comply with the policies and
procedures that the entity has implemented pursuant to
subsection (h)(1);
(B) has a history of claims filed against him or
her as provided for under this section that is outside
the norm for licensed or certified health care
practitioners within the same specialty;
(C) refused to reasonably cooperate with the
Attorney General in defending against any such claim;
(D) provided false information relevant to the
individual's performance of his or her duties to the
Secretary, the Attorney General, or an applicant for or
recipient of funds under this Act; or
(E) was the subject of disciplinary action taken by
a State medical licensing authority or a State or
national professional society.
(2) A final determination by the Attorney General under
this subsection that an individual physician or other licensed
or certified health care professional shall not be deemed to be
an employee of the Public Health Service shall be effective
upon receipt by the entity employing such individual of notice
of such determination, and shall apply only to acts or
omissions occurring after the date such notice is received.
(j) In the case of a health care provider who is an
officer, employee, or contractor of an entity described in
subsection (g)(4), section 335(e) shall apply with respect to
the provider to the same extent and in the same manner as such
section applies to any member of the National Health Service
Corps.
(k)(1)(A) For each fiscal year, the Attorney General, in
consultation with the Secretary, shall estimate by the
beginning of the year the amount of all claims which are
expected to arise under this section (together with related
fees and expenses of witnesses) for which payment is expected
to be made in accordance with section 1346 and chapter 171 of
title 28, United States Code, from the acts or omissions,
during the calendar year that begins during that fiscal year,
of entities described in subsection (g)(4) and of officers,
employees, or contractors (subject to subsection (g)(5)) of
such entities.
(B) The estimate under subparagraph (A) shall take into
account--
(i) the value and frequency of all claims for
damage for personal injury, including death, resulting
from the performance of medical, surgical, dental, or
related functions by entities described in subsection
(g)(4) or by officers, employees, or contractors
(subject to subsection (g)(5)) of such entities who are
deemed to be employees of the Public Health Service
under subsection (g)(1) that, during the preceding 5-
year period, are filed under this section or, with
respect to years occurring before this subsection takes
effect, are filed against persons other than the United
States,
(ii) the amounts paid during that 5-year period on
all claims described in clause (i), regardless of when
such claims were filed, adjusted to reflect payments
which would not be permitted under section 1346 and
chapter 171 of title 28, United States Code, and
(iii) amounts in the fund established under
paragraph (2) but unspent from prior fiscal years.
(2) Subject to appropriations, for each fiscal year, the
Secretary shall establish a fund of an amount equal to the
amount estimated under paragraph (1) that is attributable to
entities receiving funds under each of the grant programs
described in paragraph (4) of subsection (g), but not to exceed
a total of $10,000,000 for each such fiscal year.
Appropriations for purposes of this paragraph shall be made
separate from appropriations made for purposes of sections 329,
330 and 340A.
(3) In order for payments to be made for judgments against
the United States (together with related fees and expenses of
witnesses) pursuant to this section arising from the acts or
omissions of entities described in subsection (g)(4) and of
officers, \1\ employees, or contractors (subject to subsection
(g)(5)) of such entities, the total amount contained within the
fund established by the Secretary under paragraph (2) for a
fiscal year shall be transferred not later than the December 31
that occurs during the fiscal year to the appropriate accounts
in the Treasury.
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\1\ Section 3(2) of Public Law 104-73 (109 Stat. 778) provides that
subsection (k)(3) is amended by inserting ``governing board member,''
after ``officer,''. The amendment cannot be executed because the latter
term does not appear. (Compare ``officer,'' and ``officers,''.)
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(l)(1) If a civil action or proceeding is filed in a State
court against any entity described in subsection (g)(4) or any
officer, governing board member, employee, or any contractor of
such an entity for damages described in subsection (a), the
Attorney General, within 15 days after being notified of such
filing, shall make an appearance in such court and advise such
court as to whether the Secretary has determined under
subsections (g) and (h), that such entity, officer, governing
board member, employee, or contractor of the entity is deemed
to be an employee of the Public Health Service for purposes of
this section with respect to the actions or omissions that are
the subject of such civil action or proceeding. Such advice
shall be deemed to satisfy the provisions of subsection (c)
that the Attorney General certify that an entity, officer,
governing board member, employee, or contractor of the entity
was acting within the scope of their employment or
responsibility.
(2) If the Attorney General fails to appear in State court
within the time period prescribed under paragraph (1), upon
petition of any entity or officer, governing board member,
employee, or contractor of the entity named, the civil action
or proceeding shall be removed to the appropriate United States
district court. The civil action or proceeding shall be stayed
in such court until such court conducts a hearing, and makes a
determination, as to the appropriate forum or procedure for the
assertion of the claim for damages described in subsection (a)
and issues an order consistent with such determination.
(m)(1) An entity or officer, governing board member,
employee, or contractor of an entity described in subsection
(g)(1) shall, for purposes of this section, be deemed to be an
employee of the Public Health Service with respect to services
provided to individuals who are enrollees of a managed care
plan if the entity contracts with such managed care plan for
the provision of services.
(2) Each managed care plan which enters into a contract
with an entity described in subsection (g)(4) shall deem the
entity and any officer, governing board member, employee, or
contractor of the entity as meeting whatever malpractice
coverage requirements such plan may require of contracting
providers for a calendar year if such entity or officer,
governing board member, employee, or contractor of the entity
has been deemed to be an employee of the Public Health Service
for purposes of this section for such calendar year. Any plan
which is found by the Secretary on the record, after notice and
an opportunity for a full and fair hearing, to have violated
this subsection shall upon such finding cease, for a period to
be determined by the Secretary, to receive and to be eligible
to receive any Federal funds under titles XVIII or XIX of the
Social Security Act.
(3) For purposes of this subsection, the term ``managed
care plan'' shall mean health maintenance organizations and
similar entities that contract at-risk with payors for the
provision of health services or plan enrollees and which
contract with providers (such as entities described in
subsection (g)(4)) for the delivery of such services to plan
enrollees.
(n)(1) Not later than one year after the date of the
enactment of the Federally Supported Health Centers Assistance
Act of 1995, the Comptroller General of the United States shall
submit to the Congress a report on the following:
(A) The medical malpractice liability claims
experience of entities that have been deemed to be
employees for purposes of this section.
(B) The risk exposure of such entities.
(C) The value of private sector risk-management
services, and the value of risk-management services and
procedures required as a condition of receiving a grant
under section 329, 330, or 340A.
(D) A comparison of the costs and the benefits to
taxpayers of maintaining medical malpractice liability
coverage for such entities pursuant to this section,
taking into account--
(i) a comparison of the costs of premiums
paid by such entities for private medical
malpractice liability insurance with the cost
of coverage pursuant to this section; and
(ii) an analysis of whether the cost of
premiums for private medical malpractice
liability insurance coverage is consistent with
the liability claims experience of such
entities.
(2) The report under paragraph (1) shall include the
following:
(A) A comparison of--
(i) an estimate of the aggregate amounts
that such entities (together with the officers,
governing board members, employees, and
contractors of such entities who have been
deemed to be employees for purposes of this
section) would have directly or indirectly paid
in premiums to obtain medical malpractice
liability insurance coverage if this section
were not in effect; with
(ii) the aggregate amounts by which the
grants received by such entities under this Act
were reduced pursuant to subsection (k)(2).
(B) A comparison of--
(i) an estimate of the amount of privately
offered such insurance that such entities
(together with the officers, governing board
members, employees, and contractors of such
entities who have been deemed to be employees
for purposes of this section) purchased during
the three-year period beginning on January 1,
1993; with
(ii) an estimate of the amount of such
insurance that such entities (together with the
officers, governing board members, employees,
and contractors of such entities who have been
deemed to be employees for purposes of this
section) will purchase after the date of the
enactment of the Federally Supported Health
Centers Assistance Act of 1995.
(C) An estimate of the medical malpractice
liability loss history of such entities for the 10-year
period preceding October 1, 1996, including but not
limited to the following:
(i) Claims that have been paid and that are
estimated to be paid, and legal expenses to
handle such claims that have been paid and that
are estimated to be paid, by the Federal
Government pursuant to deeming entities as
employees for purposes of this section.
(ii) Claims that have been paid and that
are estimated to be paid, and legal expenses to
handle such claims that have been paid and that
are estimated to be paid, by private medical
malpractice liability insurance.
(D) An analysis of whether the cost of premiums for
private medical malpractice liability insurance
coverage is consistent with the liability claims
experience of entities that have been deemed as
employees for purposes of this section.
(3) In preparing the report under paragraph (1), the
Comptroller General of the United States shall consult with
public and private entities with expertise on the matters with
which the report is concerned.
(o)(1) For purposes of this section, a free clinic health
professional shall in providing a qualifying health service to
an individual, or an officer, governing board member, employee,
or contractor of a free clinic shall in providing services for
the free clinic, be deemed to be an employee of the Public
Health Service for a calendar year that begins during a fiscal
year for which a transfer was made under paragraph (6)(D). The
preceding sentence is subject to the provisions of this
subsection.
(2) In providing a health service to an individual, a
health care practitioner shall for purposes of this subsection
be considered to be a free clinic health professional if the
following conditions are met:
(A) The service is provided to the individual at a
free clinic, or through offsite programs or events
carried out by the free clinic.
(B) The free clinic is sponsoring the health care
practitioner pursuant to paragraph (5)(C).
(C) The service is a qualifying health service (as
defined in paragraph (4)).
(D) Neither the health care practitioner nor the
free clinic receives any compensation for the service
from the individual or from any third-party payor
(including reimbursement under any insurance policy or
health plan, or under any Federal or State health
benefits program). With respect to compliance with such
condition:
(i) The health care practitioner may
receive repayment from the free clinic for
reasonable expenses incurred by the health care
practitioner in the provision of the service to
the individual.
(ii) The free clinic may accept voluntary
donations for the provision of the service by
the health care practitioner to the individual.
(E) Before the service is provided, the health care
practitioner or the free clinic provides written notice
to the individual of the extent to which the legal
liability of the health care practitioner is limited
pursuant to this subsection (or in the case of an
emergency, the written notice is provided to the
individual as soon after the emergency as is
practicable). If the individual is a minor or is
otherwise legally incompetent, the condition under this
subparagraph is that the written notice be provided to
a legal guardian or other person with legal
responsibility for the care of the individual.
(F) At the time the service is provided, the health
care practitioner is licensed or certified in
accordance with applicable law regarding the provision
of the service.
(3)(A) For purposes of this subsection, the term ``free
clinic'' means a health care facility operated by a nonprofit
private entity meeting the following requirements:
(i) The entity does not, in providing health
services through the facility, accept reimbursement
from any third-party payor (including reimbursement
under any insurance policy or health plan, or under any
Federal or State health benefits program).
(ii) The entity, in providing health services
through the facility, either does not impose charges on
the individuals to whom the services are provided, or
imposes a charge according to the ability of the
individual involved to pay the charge.
(iii) The entity is licensed or certified in
accordance with applicable law regarding the provision
of health services.
(B) With respect to compliance with the conditions under
subparagraph (A), the entity involved may accept voluntary
donations for the provision of services.
(4) For purposes of this subsection, the term ``qualifying
health service'' means any medical assistance required or
authorized to be provided in the program under title XIX of the
Social Security Act, without regard to whether the medical
assistance is included in the plan submitted under such program
by the State in which the health care practitioner involved
provides the medical assistance. References in the preceding
sentence to such program shall as applicable be considered to
be references to any successor to such program.
(5) Subsection (g) (other than paragraphs (3) through (5))
and subsections (h), (i), and (l) apply to a health care
practitioner for purposes of this subsection to the same extent
and in the same manner as such subsections apply to an officer,
governing board member, employee, or contractor of an entity
described in subsection (g)(4), subject to paragraph (6) and
subject to the following:
(A) The first sentence of paragraph (1) applies in
lieu of the first sentence of subsection (g)(1)(A).
(B) This subsection may not be construed as deeming
any free clinic to be an employee of the Public Health
Service for purposes of this section.
(C) With respect to a free clinic, a health care
practitioner is not a free clinic health professional
unless the free clinic sponsors the health care
practitioner. For purposes of this subsection, the free
clinic shall be considered to be sponsoring the health
care practitioner if--
(i) with respect to the health care
practitioner, the free clinic submits to the
Secretary an application meeting the
requirements of subsection (g)(1)(D); and
(ii) the Secretary, pursuant to subsection
(g)(1)(E), determines that the health care
practitioner is deemed to be an employee of the
Public Health Service.
(D) In the case of a health care practitioner who
is determined by the Secretary pursuant to subsection
(g)(1)(E) to be a free clinic health professional, this
subsection applies to the health care practitioner
(with respect to the free clinic sponsoring the health
care practitioner pursuant to subparagraph (C)) for any
cause of action arising from an act or omission of the
health care practitioner occurring on or after the date
on which the Secretary makes such determination.
(E) Subsection (g)(1)(F) applies to a health care
practitioner for purposes of this subsection only to
the extent that, in providing health services to an
individual, each of the conditions specified in
paragraph (2) is met.
(6)(A) For purposes of making payments for judgments
against the United States (together with related fees and
expenses of witnesses) pursuant to this section arising from
the acts or omissions of free clinic health professionals,
there is authorized to be appropriated $10,000,000 for each
fiscal year.
(B) The Secretary shall establish a fund for purposes of
this subsection. Each fiscal year amounts appropriated under
subparagraph (A) shall be deposited in such fund.
(C) Not later than May 1 of each fiscal year, the Attorney
General, in consultation with the Secretary, shall submit to
the Congress a report providing an estimate of the amount of
claims (together with related fees and expenses of witnesses)
that, by reason of the acts or omissions of free clinic health
professionals, will be paid pursuant to this section during the
calendar year that begins in the following fiscal year.
Subsection (k)(1)(B) applies to the estimate under the
preceding sentence regarding free clinic health professionals
to the same extent and in the same manner as such subsection
applies to the estimate under such subsection regarding
officers, governing board members, employees, and contractors
of entities described in subsection (g)(4).
(D) Not later than December 31 of each fiscal year, the
Secretary shall transfer from the fund under subparagraph (B)
to the appropriate accounts in the Treasury an amount equal to
the estimate made under subparagraph (C) for the calendar year
beginning in such fiscal year, subject to the extent of amounts
in the fund.
(7)(A) This subsection takes effect on the date of the
enactment of the first appropriations Act that makes an
appropriation under paragraph (6)(A), except as provided in
subparagraph (B)(i).
(B)(i) Effective on the date of the enactment of the Health
Insurance Portability and Accountability Act of 1996--
(I) the Secretary may issue regulations for
carrying out this subsection, and the Secretary may
accept and consider applications submitted pursuant to
paragraph (5)(C); and
(II) reports under paragraph (6)(C) may be
submitted to the Congress.
(ii) For the first fiscal year for which an appropriation
is made under subparagraph (A) of paragraph (6), if an estimate
under subparagraph (C) of such paragraph has not been made for
the calendar year beginning in such fiscal year, the transfer
under subparagraph (D) of such paragraph shall be made
notwithstanding the lack of the estimate, and the transfer
shall be made in an amount equal to the amount of such
appropriation.
(p) Administration of Smallpox Countermeasures by Health
Professionals.--
(1) In general.--For purposes of this section, and
subject to other provisions of this subsection, a
covered person shall be deemed to be an employee of the
Public Health Service with respect to liability arising
out of administration of a covered countermeasure
against smallpox to an individual during the effective
period of a declaration by the Secretary under
paragraph (2)(A).
(2) Declaration by secretary concerning
countermeasure against smallpox.--
(A) Authority to issue declaration.--
(i) In general.--The Secretary may
issue a declaration, pursuant to this
paragraph, concluding that an actual or
potential bioterrorist incident or
other actual or potential public health
emergency makes advisable the
administration of a covered
countermeasure to a category or
categories of individuals.
(ii) Covered countermeasure.--The
Secretary shall specify in such
declaration the substance or substances
that shall be considered covered
countermeasures (as defined in
paragraph (7)(A)) for purposes of
administration to individuals during
the effective period of the
declaration.
(iii) Effective period.--The
Secretary shall specify in such
declaration the beginning and ending
dates of the effective period of the
declaration, and may subsequently amend
such declaration to shorten or extend
such effective period, provided that
the new closing date is after the date
when the declaration is amended.
(iv) Publication.--The Secretary
shall promptly publish each such
declaration and amendment in the
Federal Register.
(B) Liability of united states only for
administrations within scope of declaration.--
Except as provided in paragraph (5)(B)(ii), the
United States shall be liable under this
subsection with respect to a claim arising out
of the administration of a covered
countermeasure to an individual only if--
(i) the countermeasure was
administered by a qualified person, for
a purpose stated in paragraph
(7)(A)(i), and during the effective
period of a declaration by the
Secretary under subparagraph (A) with
respect to such countermeasure; and
(ii)(I) the individual was within a
category of individuals covered by the
declaration; or
(II) the qualified person
administering the countermeasure had
reasonable grounds to believe that such
individual was within such category.
(C) Presumption of administration within
scope of declaration in case of accidental
vaccinia inoculation.--
(i) In general.--If vaccinia
vaccine is a covered countermeasure
specified in a declaration under
subparagraph (A), and an individual to
whom the vaccinia vaccine is not
administered contracts vaccinia, then,
under the circumstances specified in
clause (ii), the individual--
(I) shall be rebuttably
presumed to have contracted
vaccinia from an individual to
whom such vaccine was
administered as provided by
clauses (i) and (ii) of
subparagraph (B); and
(II) shall (unless such
presumption is rebutted) be
deemed for purposes of this
subsection to be an individual
to whom a covered
countermeasure was administered
by a qualified person in
accordance with the terms of
such declaration and as
described by subparagraph (B).
(ii) Circumstances in which
presumption applies.--The presumption
and deeming stated in clause (i) shall
apply if--
(I) the individual
contracts vaccinia during the
effective period of a
declaration under subparagraph
(A) or by the date 30 days
after the close of such period;
or
(II) the individual has
resided with, or has had
contact with, an individual to
whom such vaccine was
administered as provided by
clauses (i) and (ii) of
subparagraph (B) and contracts
vaccinia after such date.
(D) Acts and omissions deemed to be within
scope of employment.--
(i) In general.--In the case of a
claim arising out of alleged
transmission of vaccinia from an
individual described in clause (ii),
acts or omissions by such individual
shall be deemed to have been taken
within the scope of such individual's
office or employment for purposes of--
(I) subsection (a); and
(II) section 1346(b) and
chapter 171 of title 28, United
States Code.
(ii) Individuals to whom deeming
applies.--An individual is described by
this clause if--
(I) vaccinia vaccine was
administered to such individual
as provided by subparagraph
(B); and
(II) such individual was
within a category of
individuals covered by a
declaration under subparagraph
(A)(i).
(3) Exhaustion; exclusivity; offset.--
(A) Exhaustion.--
(i) In general.--A person may not
bring a claim under this subsection
unless such person has exhausted such
remedies as are available under part C
of this title, except that if the
Secretary fails to make a final
determination on a request for benefits
or compensation filed in accordance
with the requirements of such part
within 240 days after such request was
filed, the individual may seek any
remedy that may be available under this
section.
(ii) Tolling of statute of
limitations.--The time limit for filing
a claim under this subsection, or for
filing an action based on such claim,
shall be tolled during the pendency of
a request for benefits or compensation
under part C of this title.
(iii) Construction.--This
subsection shall not be construed as
superseding or otherwise affecting the
application of a requirement, under
chapter 171 of title 28, United States
Code, to exhaust administrative
remedies.
(B) Exclusivity.--The remedy provided by
subsection (a) shall be exclusive of any other
civil action or proceeding for any claim or
suit this subsection encompasses, except for a
proceeding under part C of this title.
(C) Offset.--The value of all compensation
and benefits provided under part C of this
title for an incident or series of incidents
shall be offset against the amount of an award,
compromise, or settlement of money damages in a
claim or suit under this subsection based on
the same incident or series of incidents.
(4) Certification of action by attorney general.--
Subsection (c) applies to actions under this
subsection, subject to the following provisions:
(A) Nature of certification.--The
certification by the Attorney General that is
the basis for deeming an action or proceeding
to be against the United States, and for
removing an action or proceeding from a State
court, is a certification that the action or
proceeding is against a covered person and is
based upon a claim alleging personal injury or
death arising out of the administration of a
covered countermeasure.
(B) Certification of attorney general
conclusive.--The certification of the Attorney
General of the facts specified in subparagraph
(A) shall conclusively establish such facts for
purposes of jurisdiction pursuant to this
subsection.
(5) Covered person to cooperate with united
states.--
(A) In general.--A covered person shall
cooperate with the United States in the
processing and defense of a claim or action
under this subsection based upon alleged acts
or omissions of such person.
(B) Consequences of failure to cooperate.--
Upon the motion of the United States or any
other party and upon finding that such person
has failed to so cooperate--
(i) the court shall substitute such
person as the party defendant in place
of the United States and, upon motion,
shall remand any such suit to the court
in which it was instituted if it
appears that the court lacks subject
matter jurisdiction;
(ii) the United States shall not be
liable based on the acts or omissions
of such person; and
(iii) the Attorney General shall
not be obligated to defend such action.
(6) Recourse against covered person in case of
gross misconduct or contract violation.--
(A) In general.--Should payment be made by
the United States to any claimant bringing a
claim under this subsection, either by way of
administrative determination, settlement, or
court judgment, the United States shall have,
notwithstanding any provision of State law, the
right to recover for that portion of the
damages so awarded or paid, as well as interest
and any costs of litigation, resulting from the
failure of any covered person to carry out any
obligation or responsibility assumed by such
person under a contract with the United States
or from any grossly negligent, reckless, or
illegal conduct or willful misconduct on the
part of such person.
(B) Venue.--The United States may maintain
an action under this paragraph against such
person in the district court of the United
States in which such person resides or has its
principal place of business.
(7) Definitions.--As used in this subsection, terms
have the following meanings:
(A) Covered countermeasure.--The term
``covered countermeasure'' or ``covered
countermeasure against smallpox'', means a
substance that is--
(i)(I) used to prevent or treat
smallpox (including the vaccinia or
another vaccine); or
(II) \1\ used to control or
treat the adverse effects of
vaccinia inoculation or of
administration of another
covered countermeasure; and
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\1\ Indentation is so in law. See section 3(e) of Public Law 108-20
(117 Stat. 647).
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(ii) specified in a declaration
under paragraph (2).
(B) Covered person.--The term ``covered
person'', when used with respect to the
administration of a covered countermeasure,
means a person who is--
(i) a manufacturer or distributor
of such countermeasure;
(ii) a health care entity under
whose auspices \2\--
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\2\ Clause (ii) is shown according to the probable intent of the
Congress. In amending the clause to create a subclause (I), section
3(f)(2)(B) of Public Law 108-20 (117 Stat. 647) provided that the
clause is amended by redesignating certain words ``as clause (I) and
indenting accordingly''. The reference in the amendatory instructions
to ``clause (I)'' probably should be to ``subclause (I)'', and the use
in the instructions of the word ``accordingly'' requires the exercise
of editorial judgment.
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(I) such countermeasure was
administered;
(II) a determination was
made as to whether, or under
what circumstances, an
individual should receive a
covered countermeasure;
(III) the immediate site of
administration on the body of a
covered countermeasure was
monitored, managed, or cared
for; or
(IV) an evaluation was made
of whether the administration
of a countermeasure was
effective;
(iii) a qualified person who
administered such countermeasure;
(iv) a State, a political
subdivision of a State, or an agency or
official of a State or of such a
political subdivision, if such State,
subdivision, agency, or official has
established requirements, provided
policy guidance, supplied technical or
scientific advice or assistance, or
otherwise supervised or administered a
program with respect to administration
of such countermeasures;
(v) in the case of a claim arising
out of alleged transmission of vaccinia
from an individual--
(I) the individual who
allegedly transmitted the
vaccinia, if vaccinia vaccine
was administered to such
individual as provided by
paragraph (2)(B) and such
individual was within a
category of individuals covered
by a declaration under
paragraph (2)(A)(i); or
(II) an entity that employs
an individual described by
clause (I) or where such
individual has privileges or is
otherwise authorized to provide
health care;
(vi) an official, agent, or
employee of a person described in
clause (i), (ii), (iii), or (iv);
(vii) a contractor of, or a
volunteer working for, a person
described in clause (i), (ii), or (iv),
if the contractor or volunteer performs
a function for which a person described
in clause (i), (ii), or (iv) is a
covered person; or
(viii) an individual who has
privileges or is otherwise authorized
to provide health care under the
auspices of an entity described in
clause (ii) or (v)(II).
(C) Qualified person.--The term ``qualified
person'', when used with respect to the
administration of a covered countermeasure,
means a licensed health professional or other
individual who \1\--
---------------------------------------------------------------------------
\1\ Subparagraph (C) is shown according to the probable intent of
the Congress. In amending the subparagraph to create a clause (i),
section 3(g) of Public Law 108-20 (117 Stat. 648) provided that the
subparagraph is amended by redesignating certain words ``as clause (i)
and indenting accordingly''. The use in the amendatory instructions of
the word ``accordingly'' requires the exercise of editorial judgment.
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(i) is authorized to administer
such countermeasure under the law of
the State in which the countermeasure
was administered; or
(ii) is otherwise authorized by the
Secretary to administer such
countermeasure.
(D) Arising out of administration of a
covered countermeasure.--The term ``arising out
of administration of a covered
countermeasure'', when used with respect to a
claim or liability, includes a claim or
liability arising out of--
(i) determining whether, or under
what conditions, an individual should
receive a covered countermeasure;
(ii) obtaining informed consent of
an individual to the administration of
a covered countermeasure;
(iii) monitoring, management, or
care of an immediate site of
administration on the body of a covered
countermeasure, or evaluation of
whether the administration of the
countermeasure has been effective; or
(iv) transmission of vaccinia virus
by an individual to whom vaccinia
vaccine was administered as provided by
paragraph (2)(B).
administration of grants in certain multigrant projects
Sec. 226. \2\ [235] For the purpose of facilitating the
administration of, and expediting the carrying out of the
purposes of, the programs established by titles VII, VIII, and
IX, and sections 304, 314(a), 314(b), 314(c), 314(d), and
314(e) of this Act in situations in which grants are sought or
made under two or more of such programs with respect to a
single project, the Secretary is authorized to promulgate
regulations--
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\2\ Former section 225 was repealed by section 408(b)(1) of Public
Law 94-484 (90 Stat. 2281). Subpart III of part D of title III now
applies to the matter with which former section 225 was concerned.
---------------------------------------------------------------------------
(1) under which the administrative functions under
such programs with respect to such project will be
performed by a single administrative unit which is the
administrative unit charged with the administration of
any of such programs or is the administrative unit
charged with the supervision of two or more of such
programs;
(2) designed to reduce the number of applications,
reports, and other materials required under such
programs to be submitted with respect to such project,
and otherwise to simplify, consolidate, and make
uniform (to the extent feasible), the data and
information required to be contained in such
applications, reports, and other materials; and
(3) under which inconsistent or duplicative
requirements imposed by such programs will be revised
and made uniform with respect to such project;
except that nothing in this section shall be construed to
authorize the Secretary to waive or suspend, with respect to
any such project, any requirement with respect to any of such
programs if such requirement is imposed by law or by any
regulation required by law.
orphan products board
Sec. 227. [236] (a) There is established in the Department
of Health and Human Services a board for the development of
drugs (including biologics) and devices (including diagnostic
products) for rare diseases or conditions to be known as the
Orphan Products Board. The Board shall be comprised of the
Assistant Secretary for Health of the Department of Health and
Human Services and representatives, selected by the Secretary,
of the Food and Drug Administration, the National Institutes of
Health, the Centers for Disease Control and Prevention, and any
other Federal department or agency which the Secretary
determines has activities relating to drugs and devices for
rare diseases or conditions. The Assistant Secretary for Health
shall chair the Board.
(b) The function of the Board shall be to promote the
development of drugs and devices for rare diseases or
conditions and the coordination among Federal, other public,
and private agencies in carrying out their respective functions
relating to the development of such articles, such diseases or
conditions.
(c) In the case of drugs for rare diseases or conditions
the Board shall--
(1) evaluate--
(A) the effect of subchapter B of the
Federal Food, Drug, and Cosmetic Act on the
development of such drugs, and
(B) the implementation of such subchapter;
\1\
---------------------------------------------------------------------------
\1\ So in law. The semicolon probably should be a comma.
---------------------------------------------------------------------------
(2) evaluate the activities of the National
Institutes of Health for the development of drugs for
such diseases or conditions,
(3) assure appropriate coordination among the Food
and Drug Administration, the National Institutes of
Health and the Centers for Disease Control and
Prevention in the carrying out of their respective
functions relating to the development of drugs for such
diseases or conditions to assure that the activities of
each agency are complementary.
(4) assure appropriate coordination among all
interested Federal agencies, manufacturers, and
organizations representing patients, in their
activities relating to such drugs,
(5) with the consent of the sponsor of a drug for a
rare disease or condition exempt under section 505(i)
of the Federal Food, Drug, and Cosmetic Act or
regulations issued under such section, inform
physicians and the public respecting the availability
of such drug for such disease or condition and inform
physicians and the public respecting the availability
of drugs approved under section 505(c) of such Act or
licensed under section 351 of this Act for rare
diseases or conditions,
(6) seek business entities and others to undertake
the sponsorship of drugs for rare diseases or
conditions, seek investigators to facilitate the
development of such drugs, and seek business entities
to participate in the distribution of such drugs, and
(7) recognize the efforts of public and private
entities and individuals in seeking the development of
drugs for rare diseases or conditions and in developing
such drugs.
(d) The Board shall consult with interested persons
respecting the activities of the Board under this section and
as part of such consultation shall provide the opportunity for
the submission of oral views.
(e) The Board shall submit to the Committee on Labor and
Human Resources of the Senate and the Committee on Energy and
Commerce of the House of Representatives an annual report--
(1) identifying the drugs which have been
designated under section 526 of the Federal Food, Drug,
and Cosmetic Act for a rare disease or condition,
(2) describing the activities of the Board, and
(3) containing the results of the evaluations
carried out by the Board.
The Director of the National Institutes of Health shall submit
to the Board for inclusion in the annual report a report on the
rare disease and condition research activities of the
Institutes of the National Institutes of Health; the Secretary
of the Treasury shall submit to the Board for inclusion in the
annual report a report on the use of the credit against tax
provided by section 44H of the Internal Revenue Code of 1954;
and the Secretary of Health and Human Services shall submit to
the Board for inclusion in the annual report a report on the
program of assistance under section 5 of the Orphan Drug Act
for the development of drugs for rare diseases and conditions.
Each annual report shall be submitted by June 1 of each year
for the preceding calendar year.
silvio o. conte senior biomedical research service
Sec. 228. [237] (a)(1) There shall be in the Public Health
Service a Silvio O. Conte Senior Biomedical Research Service,
not to exceed 500 members.
(2) The authority established in paragraph (1) regarding
the number of members in the Silvio O. Conte Senior Biomedical
Research Service is in addition to any authority established
regarding the number of members in the commissioned Regular
Corps, in the Reserve Corps, and in the Senior Executive
Service. Such paragraph may not be construed to require that
the number of members in the commissioned Regular Corps, in the
Reserve Corps, or in the Senior Executive Service be reduced to
offset the number of members serving in the Silvio O. Conte
Senior Biomedical Research Service (in this section referred to
as the ``Service'').
(b) The Service shall be appointed by the Secretary without
regard to the provisions of title 5, United States Code,
regarding appointment, and shall consist of individuals
outstanding in the field of biomedical research or clinical
research evaluation. No individual may be appointed to the
Service unless such individual (1) has earned a doctoral level
degree in biomedicine or a related field, and (2) meets the
qualification standards prescribed by the Office of Personnel
Management for appointment to a position at GS-15 of the
General Schedule. Notwithstanding any previous applicability to
an individual who is a member of the Service, the provisions of
subchapter I of chapter 35 (relating to retention preference),
chapter 43 (relating to performance appraisal and performance
actions), chapter 51 (relating to classification), subchapter
III of chapter 53 (relating to General Schedule pay rates), and
chapter 75 (relating to adverse actions) of title 5, United
States Code, shall not apply to any member of the Service.
(c) The Secretary shall develop a performance appraisal
system designed to--
(1) provide for the systematic appraisal of the
performance of members, and
(2) encourage excellence in performance by members.
(d)(1) The Secretary shall determine, subject to the
provisions of this subsection, the pay of members of the
Service.
(2) The pay of a member of the Service shall not be less
than the minimum rate payable for GS-15 of the General Schedule
and shall not exceed the rate payable for level I of the
Executive Schedule unless approved by the President under
section 5377(d)(2) of title 5, United States Code.
(e) The Secretary may, upon the request of a member who--
(1) performed service in the employ of an
institution of higher education immediately prior to
his appointment as a member of the Service, and
(2) retains the right to continue to make
contributions to the retirement system of such
institution,
contribute an amount not to exceed 10 percent per annum of the
member's basic pay to such institution's retirement system on
behalf of such member. A member who requests that such
contribution be made shall not be covered by, or earn service
credit under, any retirement system established for employees
of the United States under title 5, United States Code, but
such service shall be creditable for determining years of
service under section 6303(a) of such title.
(f) Subject to the following sentence, the Secretary may,
notwithstanding the provisions of title 5, United States Code,
regarding appointment, appoint an individual who is separated
from the Service involuntarily and without cause to a position
in the competitive civil service at GS-15 of the General
Schedule, and such appointment shall be a career appointment.
In the case of such an individual who immediately prior to his
appointment to the Service was not a career appointee in the
civil service or the Senior Executive Service, such appointment
shall be in the excepted civil service and may not exceed a
period of 2 years.
(g) The Secretary shall promulgate such rules and
regulations, not inconsistent with this section, as may be
necessary for the efficient administration of the Service.
SEC. 229. \1\ [237A] HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S
HEALTH.
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\1\ Section 3509 of the Patient Protection and Affordable Care Act
(Public Law 111-148, enacted March 23, 2010) established offices of
womens health in the Office of the Secretary of HHS (this section), the
Centers for Disease Control and Prevention (section 310A of this Act),
the Agency for Healthcare Research and Quality (section 925 of this
Act), the Health Resources and Services Administration (section 713 of
the Social Security Act), and the Food and Drug Administration (section
1011 of the Federal Food, Drug, and Cosmetic Act).
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(a) Establishment of Office.--There is established within
the Office of the Secretary, an Office on Women's Health
(referred to in this section as the ``Office''). The Office
shall be headed by a Deputy Assistant Secretary for Women's
Health who may report to the Secretary.
(b) Duties.--The Secretary, acting through the Office, with
respect to the health concerns of women, shall--
(1) establish short-range and long-range goals and
objectives within the Department of Health and Human
Services and, as relevant and appropriate, coordinate
with other appropriate offices on activities within the
Department that relate to disease prevention, health
promotion, service delivery, research, and public and
health care professional education, for issues of
particular concern to women throughout their lifespan;
(2) provide expert advice and consultation to the
Secretary concerning scientific, legal, ethical, and
policy issues relating to women's health;
(3) monitor the Department of Health and Human
Services' offices, agencies, and regional activities
regarding women's health and identify needs regarding
the coordination of activities, including intramural
and extramural multidisciplinary activities;
(4) establish a Department of Health and Human
Services Coordinating Committee on Women's Health,
which shall be chaired by the Deputy Assistant
Secretary for Women's Health and composed of senior
level representatives from each of the agencies and
offices of the Department of Health and Human Services;
(5) establish a National Women's Health Information
Center to--
(A) facilitate the exchange of information
regarding matters relating to health
information, health promotion, preventive
health services, research advances, and
education in the appropriate use of health
care;
(B) facilitate access to such information;
(C) assist in the analysis of issues and
problems relating to the matters described in
this paragraph; and
(D) provide technical assistance with
respect to the exchange of information
(including facilitating the development of
materials for such technical assistance);
(6) coordinate efforts to promote women's health
programs and policies with the private sector; and
(7) through publications and any other means
appropriate, provide for the exchange of information
between the Office and recipients of grants, contracts,
and agreements under subsection (c), and between the
Office and health professionals and the general public.
(c) Grants and Contracts Regarding Duties.--
(1) Authority.--In carrying out subsection (b), the
Secretary may make grants to, and enter into
cooperative agreements, contracts, and interagency
agreements with, public and private entities, agencies,
and organizations.
(2) Evaluation and dissemination.--The Secretary
shall directly or through contracts with public and
private entities, agencies, and organizations, provide
for evaluations of projects carried out with financial
assistance provided under paragraph (1) and for the
dissemination of information developed as a result of
such projects.
(d) Reports.--Not later than 1 year after the date of
enactment of this section, and every second year thereafter,
the Secretary shall prepare and submit to the appropriate
committees of Congress a report describing the activities
carried out under this section during the period for which the
report is being prepared.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2010 through 2014.
Part B--Miscellaneous Provisions
gifts
Sec. 231. [238] (a) The Secretary is authorized to accept
on behalf of the United States gifts made unconditionally by
will or otherwise for the benefit of the Service or for the
carrying out of any of its functions. Conditional gifts may be
so accepted if recommended by the Surgeon General, and the
principal of and income from any such conditional gift shall be
held, invested, reinvested, and used in accordance with its
conditions, but no gift shall be accepted which is conditioned
upon any expenditure not to be met therefrom or from the income
thereof unless such expenditure has been approved by Act of
Congress.
(b) Any unconditional gift of money accepted, pursuant to
the authority granted in subsection (a) of this section, the
net proceeds from the liquidation (pursuant to subsection (c)
or subsection (d) of this section) of any other property so
accepted, and the proceeds of insurance on any such gift
property not used for its restoration, shall be deposited in
the Treasury of the United States and are hereby appropriated
and shall be held in trust by the Secretary of the Treasury for
the benefit of the Service, and he may invest and reinvest such
funds in interest-bearing obligations of the United States or
in obligations guaranteed as to both principal and interest by
the United States. Such gifts and the income from such
investments shall be available for expenditure in the operation
of the Service and the performance of its functions, subject to
the same examination and audit as is provided for
appropriations made for the Service by Congress.
(c) The evidences of any unconditional gift of intangible
personal property, other than money, accepted pursuant to the
authority granted in subsection (a) of this section shall be
deposited with the Secretary of the Treasury and he, in his
discretion, may hold them, or liquidate them except that they
shall be liquidated upon the request of the Secretary, whenever
necessary to meet payments required in the operation of the
Service or the performance of its functions. The proceeds and
income from any such property held by the Secretary of the
Treasury shall be available for expenditure as is provided in
subsection (b) of this section.
(d) The Secretary shall hold any real property or any
tangible personal property accepted unconditionally pursuant to
the authority granted in subsection (a) of this section and he
shall permit such property to be used for the operation of the
Service and the performance of its functions or he may lease or
hire such property, and may insure such property, and deposit
the income thereof with the Secretary of the Treasury to be
available for expenditure as provided in subsection (b) of this
section: Provided, That the income from any such real property
or tangible personal property shall be available for
expenditure in the discretion of the Secretary for the
maintenance, preservation, or repair and insurance of such
property and that any proceeds from insurance may be used to
restore the property insured. Any such property when not
required for the operation of the Service or the performance of
its functions may be liquidated by the Secretary, and the
proceeds thereof deposited with the Secretary of the Treasury,
whenever in his judgment the purposes of the gifts will be
served thereby.
use of immigration station hospitals
Sec. 232. [238a] The Immigration and Naturalization Service
may, by agreement of the heads of the departments concerned,
permit the Public Health Service to use hospitals at
immigration stations for the care of Public Health Service
patients. The Surgeon General shall reimburse the Immigration
and Naturalization Service for the actual cost of furnishing
fuel, light, water, telephone, and similar supplies and
services, which reimbursement shall be covered into the proper
Immigration and Naturalization Service appropriation, or such
costs may be paid from working funds established as provided by
law, but no charge shall be made for the expense of physical
upkeep of the hospitals. The Immigration and Naturalization
Service shall reimburse the Surgeon General for the care and
treatment of persons detained in hospitals of the Public Health
Service at the request of the Immigration and Naturalization
Service unless such persons are entitled to care and treatment
under section 322(a). \1\
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\1\ Subsection (a) of section 322 was repealed by section 986 of
Public Law 97-35, and the Public Law redesignated former subsection (c)
as subsection (a). Section 232 (above) was enacted before this repeal
and redesignation. Current section 322(a) authorizes the treatment and
care of certain persons. (Section 232 was originally enacted as section
502, and was subsequently redesignated by Public Laws 98-24, 99-660,
100-690, and 103-43.)
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money collected for care of patients
Sec. 233. [238b] Money collected as provided by law for
expenses incurred in the care and treatment of foreign seamen,
and money received for the care and treatment of pay patients,
including any amounts received from any executive department on
account of care and treatment of pay patients, shall be covered
into the appropriation from which the expenses of such care and
treatment were paid.
transportation of remains of officers
Sec. 234. [238c] Appropriations available for traveling
expenses of the Service shall be available for meeting the cost
of preparation for burial and of transportation to the place of
burial of remains of commissioned officers, and of personnel
specified in regulations, who die in line of duty.
Appropriations available for carrying out the provisions of
this Act shall also be available for the payment of such
expenses relating to the recovery, care, and disposition of the
remains of personnel or their dependents as may be authorized
under other provisions of law.
grants to federal institutions
Sec. 235. [238d] Appropriations to the Public Health
Service available under this Act for research, training, or
demonstration project grants or for grants to expand existing
treatment and research programs and facilities for alcoholism,
narcotic addiction, drug abuse, and drug dependence and
appropriations under title VI of the Mental Health Systems Act
shall also be available, on the same terms and conditions as
apply to non-Federal institutions, for grants for the same
purpose to Federal institutions, except that grants to such
Federal institutions may be funded at 100 per centum of the
costs.
transfer of funds
Sec. 236. [238e] For the purpose of any reorganization
under section 202, the Secretary, with the approval of the
Director of the Bureau of the Budget, \1\ is authorized to make
such transfers of funds between appropriations as may be
necessary for the continuance of transferred functions.
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\1\ Now the Office of Management and Budget.
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availability of appropriations
Sec. 237. [238f] Appropriations for carrying out the
purposes of this Act shall be available for expenditure for
personal services and rent at the seat of Government; books of
reference, periodicals, and exhibits; printing and binding;
transporting in Government-owned automotive equipment, to and
from school, children of personnel who have quarters for
themselves and their families at stations determined by the
Surgeon General to be isolated stations; expenses incurred in
pursuing, identifying, and returning prisoners who escape from
any hospital, institution, or station of the Service or from
the custody of any officer or employee of the Service,
including rewards for the capture of such prisoners;
furnishing, repairing, and cleaning such wearing apparel as may
be prescribed by the Surgeon General for use by employees in
the performance of their official duties; reimbursing officers
and employees, subject to regulations of the Secretary, for the
cost of repairing or replacing their personal belongings
damaged or destroyed by patients while such officers or
employees are engaged in the performance of their official
duties; and maintenance of buildings of the National Institutes
of Health.
unauthorized wearing of uniforms
Sec. 238. [238g] Except as may be authorized by regulations
of the President, the insignia and uniform of commissioned
officers of the Service, or any distinctive part of such
insignia or uniform, or any insignia or uniform any part of
which is similar to a distinctive part thereof, shall not be
worn, after the promulgation of such regulations, by any person
other than a commissioned officer of the Service.
biannual report
Sec. 239. [238h] The Surgeon General shall transmit to the
Secretary, for submission to the Congress, on January 1, 1995,
and on January 1, every 2 years thereafter, a full report of
the administration of the functions of the Service under this
Act, including a detailed statement of receipts and
disbursements.
memorials and other acknowledgments
Sec. 240. [238i] The Secretary may provide for suitably
acknowledging, within the Department (whether by memorials,
designations, or other suitable acknowledgments), (1) efforts
of persons who have contributed substantially to the health of
the Nation and (2) gifts for use in activities of the
Department related to health.
evaluation of programs
Sec. 241. [238j] (a) In General.--Such portion as the
Secretary shall determine, but not less than 0.2 percent nor
more than 1 percent, of any amounts appropriated for programs
authorized under this Act shall be made available for the
evaluation (directly, or by grants of contracts) of the
implementation and effectiveness of such programs.
(b) Report on Evaluations.--Not later than February 1 of
each year, the Secretary shall prepare and submit to the
Committee on Labor and Human Resources of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report summarizing the findings of the
evaluations conducted under subsection (a).
contract authority
Sec. 242. [238k] The authority of the Secretary to enter
into contracts under this Act shall be effective for any fiscal
year only to such extent or in such amounts as are provided in
advance by appropriation Acts.
recovery
Sec. 243. [238l] (a) If any facility with respect to
which funds have been paid under the Community Mental Health
Centers Act (as such Act was in effect prior to October 1,
1981) is, at any time within twenty years after the completion
of remodeling, construction, or expansion or after the date of
its acquisition--
(1) sold or transferred to any entity (A) which
would not have been qualified to file an application
under section 222 of such Act (as such section was in
effect prior to October 1, 1981) or (B) which is
disapproved as a transferee by the State mental health
agency or by another entity designated by the chief
executive officer of the State, or
(2) ceases to be used by a community mental health
center in the provision of comprehensive mental health
services,
the United States shall be entitled to recover from the
transferor, transferee, or owner of the facility, the base
amount prescribed by subsection (c)(1) plus the interest (if
any) prescribed by subsection (c)(2).
(b) The transferor and transferee of a facility that is
sold or transferred as described in subsection (a)(1), or the
owner of a facility the use of which changes as described in
subsection (a)(2), shall provide the Secretary written notice
of such sale, transfer, or change within 10 days after the date
on which such sale, transfer, or cessation of use occurs or
within 30 days after the date of enactment of this subsection,
whichever is later.
(c)(1) The base amount that the United States is entitled
to recover under subsection (a) is the amount bearing the same
ratio to the then value (as determined by the agreement of the
parties or in an action brought in the district court of the
United States for the district in which the facility is
situated) of so much of the facility as constituted an approved
project or projects as the amount of the Federal participation
bore to the cost of the remodeling, construction, expansion, or
acquisition of the project or projects.
(2)(A) The interest that the United States is entitled to
recover under subsection (a) is the interest for the period (if
any) described in subparagraph (B) at a rate (determined by the
Secretary) based on the average of the bond equivalent rates of
ninety-one-day Treasury bills auctioned during that period.
(B) The period referred to in subparagraph (A) is the
period beginning--
(i) if notice is provided as prescribed by
subsection (b), 191 days after the date on which such
sale, transfer, or cessation of use occurs, or
(ii) if notice is not provided as prescribed by
subsection (b), 11 days after such sale, transfer, or
cessation of use occurs,
and ending on the date the amount the United States is entitled
to recover is collected.
(d) The Secretary may waive the recovery rights of the
United States under subsection (a) with respect to a facility
(under such conditions as the Secretary may establish by
regulation) if the Secretary determines that there is good
cause for waiving such rights.
(e) The right of recovery of the United States under
subsection (a) shall not, prior to judgment, constitute a lien
on any facility.
use of fiscal agents
Sec. 244. [238m] (a) The Secretary may enter into contracts
with fiscal agents--
(1)(A) to determine the amounts payable to persons
who, on behalf of the Indian Health Service, furnish
health services to eligible Indians,
(B) to determine the amounts payable to persons
who, on behalf of the Public Health Service, furnish
health services to individuals pursuant to section 319
or 322,
(2) to receive, disburse, and account for funds in
making payments described in paragraph (1),
(3) to make such audits of records as may be
necessary to assure that these payments are proper, and
(4) to perform such additional functions as may be
necessary to carry out the functions described in
paragraphs (1) through (3).
(b)(1) Contracts under subsection (a) may be entered into
without regard to section 3709 of the Revised Statutes (41
U.S.C. 5) or any other provision of law requiring competition.
(2) No such contract shall be entered into with an entity
unless the Secretary finds that the entity will perform its
obligations under the contract efficiently and effectively and
will meet such requirements as to financial responsibility,
legal authority, and other matters as he finds pertinent.
(c) A contract under subsection (a) may provide for
advances of funds to enable entities to make payments under the
contract.
(d) Subsections (d) and (e) of section 1842 of the Social
Security Act shall apply to contracts with entities under
subsection (a) in the same manner as they apply to contracts
with carriers under that section.
(e) In this section, the term ``fiscal agent'' means a
carrier described in section 1842(f)(1) of the Social Security
Act and includes, with respect to contracts under subsection
(a)(1)(A), an Indian tribe or tribal organization acting under
contract with the Secretary under the Indian Self-Determination
Act (Public Law 93-638).
abortion-related discrimination in governmental activities regarding
training and licensing of physicians
Sec. 245. [238n] (a) In General.--The Federal Government,
and any State or local government that receives Federal
financial assistance, may not subject any health care entity to
discrimination on the basis that--
(1) the entity refuses to undergo training in the
performance of induced abortions, to require or provide
such training, to perform such abortions, or to provide
referrals for such training or such abortions;
(2) the entity refuses to make arrangements for any
of the activities specified in paragraph (1); or
(3) the entity attends (or attended) a post-
graduate physician training program, or any other
program of training in the health professions, that
does not (or did not) perform induced abortions or
require, provide or refer for training in the
performance of induced abortions, or make arrangements
for the provision of such training.
(b) Accreditation of Postgraduate Physician Training
Programs.--
(1) In general.--In determining whether to grant a
legal status to a health care entity (including a
license or certificate), or to provide such entity with
financial assistance, services or other benefits, the
Federal Government, or any State or local government
that receives Federal financial assistance, shall deem
accredited any postgraduate physician training program
that would be accredited but for the accrediting
agency's reliance upon an accreditation standard that
requires an entity to perform an induced abortion or
require, provide, or refer for training in the
performance of induced abortions, or make arrangements
for such training, regardless of whether such standard
provides exceptions or exemptions. The government
involved shall formulate such regulations or other
mechanisms, or enter into such agreements with
accrediting agencies, as are necessary to comply with
this subsection.
(2) Rules of construction.--
(A) In general.--With respect to subclauses
(I) and (II) of section 705(a)(2)(B)(i)
(relating to a program of insured loans for
training in the health professions), the
requirements in such subclauses regarding
accredited internship or residency programs are
subject to paragraph (1) of this subsection.
(B) Exceptions.--This section shall not--
(i) prevent any health care entity
from voluntarily electing to be
trained, to train, or to arrange for
training in the performance of, to
perform, or to make referrals for
induced abortions; or
(ii) prevent an accrediting agency
or a Federal, State or local government
from establishing standards of medical
competency applicable only to those
individuals who have voluntarily
elected to perform abortions.
(c) Definitions.--For purposes of this section:
(1) The term ``financial assistance'', with respect
to a government program, includes governmental payments
provided as reimbursement for carrying out health-
related activities.
(2) The term ``health care entity'' includes an
individual physician, a postgraduate physician training
program, and a participant in a program of training in
the health professions.
(3) The term ``postgraduate physician training
program'' includes a residency training program.
SEC. 246. [238O] RESTRICTION ON USE OF FUNDS FOR ASSISTED SUICIDE,
EUTHANASIA, AND MERCY KILLING.
Appropriations for carrying out the purposes of this Act
shall not be used in a manner inconsistent with the Assisted
Suicide Funding Restriction Act of 1997. \1\
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\1\ Public Law 105-12 (111 Stat. 23).
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recommendations and guidelines regarding automated external
defibrillators for federal buildings
Sec. 247. [238p] (a) Guidelines on Placement.--The
Secretary shall establish guidelines with respect to placing
automated external defibrillator devices in Federal buildings.
Such guidelines shall take into account the extent to which
such devices may be used by lay persons, the typical number of
employees and visitors in the buildings, the extent of the need
for security measures regarding the buildings, buildings or
portions of buildings in which there are special circumstances
such as high electrical voltage or extreme heat or cold, and
such other factors as the Secretary determines to be
appropriate.
(b) Related Recommendations.--The Secretary shall publish
in the Federal Register the recommendations of the Secretary on
the appropriate implementation of the placement of automated
external defibrillator devices under subsection (a), including
procedures for the following:
(1) Implementing appropriate training courses in
the use of such devices, including the role of
cardiopulmonary resuscitation.
(2) Proper maintenance and testing of the devices.
(3) Ensuring coordination with appropriate licensed
professionals in the oversight of training of the
devices.
(4) Ensuring coordination with local emergency
medical systems regarding the placement and incidents
of use of the devices.
(c) Consultations; Consideration of Certain
Recommendations.--In carrying out this section, the Secretary
shall--
(1) consult with appropriate public and private
entities;
(2) consider the recommendations of national and
local public-health organizations for improving the
survival rates of individuals who experience cardiac
arrest in nonhospital settings by minimizing the time
elapsing between the onset of cardiac arrest and the
initial medical response, including defibrillation as
necessary; and
(3) consult with and counsel other Federal agencies
where such devices are to be used.
(d) Date Certain for Establishing Guidelines and
Recommendations.--The Secretary shall comply with this section
not later than 180 days after the date of the enactment of the
Cardiac Arrest Survival Act of 2000.
(e) Definitions.--For purposes of this section:
(1) The term ``automated external defibrillator
device'' has the meaning given such term in section
248.
(2) The term ``Federal building'' includes a
building or portion of a building leased or rented by a
Federal agency, and includes buildings on military
installations of the United States.
liability regarding emergency use of automated external defibrillators
Sec. 248. [238q] (a) Good Samaritan Protections Regarding
AEDs.--Except as provided in subsection (b), any person who
uses or attempts to use an automated external defibrillator
device on a victim of a perceived medical emergency is immune
from civil liability for any harm resulting from the use or
attempted use of such device; and in addition, any person who
acquired the device is immune from such liability, if the harm
was not due to the failure of such acquirer of the device--
(1) to notify local emergency response personnel or
other appropriate entities of the most recent placement
of the device within a reasonable period of time after
the device was placed;
(2) to properly maintain and test the device; or
(3) to provide appropriate training in the use of
the device to an employee or agent of the acquirer when
the employee or agent was the person who used the
device on the victim, except that such requirement of
training does not apply if--
(A) the employee or agent was not an
employee or agent who would have been
reasonably expected to use the device; or
(B) the period of time elapsing between the
engagement of the person as an employee or
agent and the occurrence of the harm (or
between the acquisition of the device and the
occurrence of the harm, in any case in which
the device was acquired after such engagement
of the person) was not a reasonably sufficient
period in which to provide the training.
(b) Inapplicability of Immunity.--Immunity under subsection
(a) does not apply to a person if--
(1) the harm involved was caused by willful or
criminal misconduct, gross negligence, reckless
misconduct, or a conscious, flagrant indifference to
the rights or safety of the victim who was harmed;
(2) the person is a licensed or certified health
professional who used the automated external
defibrillator device while acting within the scope of
the license or certification of the professional and
within the scope of the employment or agency of the
professional;
(3) the person is a hospital, clinic, or other
entity whose purpose is providing health care directly
to patients, and the harm was caused by an employee or
agent of the entity who used the device while acting
within the scope of the employment or agency of the
employee or agent; or
(4) the person is an acquirer of the device who
leased the device to a health care entity (or who
otherwise provided the device to such entity for
compensation without selling the device to the entity),
and the harm was caused by an employee or agent of the
entity who used the device while acting within the
scope of the employment or agency of the employee or
agent.
(c) Rules of Construction.--
(1) In general.--The following applies with respect
to this section:
(A) This section does not establish any
cause of action, or require that an automated
external defibrillator device be placed at any
building or other location.
(B) With respect to a class of persons for
which this section provides immunity from civil
liability, this section supersedes the law of a
State only to the extent that the State has no
statute or regulations that provide persons in
such class with immunity for civil liability
arising from the use by such persons of
automated external defibrillator devices in
emergency situations (within the meaning of the
State law or regulation involved).
(C) This section does not waive any
protection from liability for Federal officers
or employees under--
(i) section 224; or
(ii) sections 1346(b), 2672, and
2679 of title 28, United States Code,
or under alternative benefits provided
by the United States where the
availability of such benefits precludes
a remedy under section 1346(b) of title
28.
(2) Civil actions under federal law.--
(A) In general.--The applicability of
subsections (a) and (b) includes applicability
to any action for civil liability described in
subsection (a) that arises under Federal law.
(B) Federal areas adopting state law.--If a
geographic area is under Federal jurisdiction
and is located within a State but out of the
jurisdiction of the State, and if, pursuant to
Federal law, the law of the State applies in
such area regarding matters for which there is
no applicable Federal law, then an action for
civil liability described in subsection (a)
that in such area arises under the law of the
State is subject to subsections (a) through (c)
in lieu of any related State law that would
apply in such area in the absence of this
subparagraph.
(d) Federal Jurisdiction.--In any civil action arising
under State law, the courts of the State involved have
jurisdiction to apply the provisions of this section exclusive
of the jurisdiction of the courts of the United States.
(e) Definitions.--
(1) Perceived medical emergency.--For purposes of
this section, the term ``perceived medical emergency''
means circumstances in which the behavior of an
individual leads a reasonable person to believe that
the individual is experiencing a life-threatening
medical condition that requires an immediate medical
response regarding the heart or other cardiopulmonary
functioning of the individual.
(2) Other definitions.--For purposes of this
section:
(A) The term ``automated external
defibrillator device'' means a defibrillator
device that--
(i) is commercially distributed in
accordance with the Federal Food, Drug,
and Cosmetic Act;
(ii) is capable of recognizing the
presence or absence of ventricular
fibrillation, and is capable of
determining without intervention by the
user of the device whether
defibrillation should be performed;
(iii) upon determining that
defibrillation should be performed, is
able to deliver an electrical shock to
an individual; and
(iv) in the case of a defibrillator
device that may be operated in either
an automated or a manual mode, is set
to operate in the automated mode.
(B)(i) The term ``harm'' includes physical,
nonphysical, economic, and noneconomic losses.
(ii) The term ``economic loss'' means any
pecuniary loss resulting from harm (including
the loss of earnings or other benefits related
to employment, medical expense loss,
replacement services loss, loss due to death,
burial costs, and loss of business or
employment opportunities) to the extent
recovery for such loss is allowed under
applicable State law.
(iii) The term ``noneconomic losses'' means
losses for physical and emotional pain,
suffering, inconvenience, physical impairment,
mental anguish, disfigurement, loss of
enjoyment of life, loss of society and
companionship, loss of consortium (other than
loss of domestic service), hedonic damages,
injury to reputation and all other nonpecuniary
losses of any kind or nature.
Part C--Smallpox Emergency Personnel Protection
SEC. 261. [239] GENERAL PROVISIONS.
(a) Definitions.--For purposes of this part:
(1) Covered countermeasure.--The term ``covered
countermeasure'' means a covered countermeasure as
specified in a Declaration made pursuant to section
224(p).
(2) Covered individual.--The term ``covered
individual'' means an individual--
(A) who is a health care worker, law
enforcement officer, firefighter, security
personnel, emergency medical personnel, other
public safety personnel, or support personnel
for such occupational specialities;
(B) who is or will be functioning in a role
identified in a State, local, or Department of
Health and Human Services smallpox emergency
response plan (as defined in paragraph (7))
approved by the Secretary;
(C) who has volunteered and been selected
to be a member of a smallpox emergency response
plan described in subparagraph (B) prior to the
time at which the Secretary publicly announces
that an active case of smallpox has been
identified either within or outside of the
United States; and
(D) to whom a smallpox vaccine is
administered pursuant to such approved plan
during the effective period of the Declaration
(including the portion of such period before
the enactment of this part).
(3) Covered injury.--The term ``covered injury''
means an injury, disability, illness, condition, or
death (other than a minor injury such as minor scarring
or minor local reaction) determined, pursuant to the
procedures established under section 262, to have been
sustained by an individual as the direct result of--
(A) administration to the individual of a
covered countermeasure during the effective
period of the Declaration; or
(B) accidental vaccinia inoculation of the
individual in circumstances in which--
(i) the vaccinia is contracted
during the effective period of the
Declaration or within 30 days after the
end of such period;
(ii) smallpox vaccine has not been
administered to the individual; and
(iii) the individual has been in
contact with an individual who is (or
who was accidentally inoculated by) a
covered individual.
(4) Declaration.--The term ``Declaration'' means
the Declaration Regarding Administration of Smallpox
Countermeasures issued by the Secretary on January 24,
2003, and published in the Federal Register on January
28, 2003.
(5) Effective period of the declaration.--The term
``effective period of the Declaration'' means the
effective period specified in the Declaration, unless
extended by the Secretary.
(6) Eligible individual.--The term ``eligible
individual'' means an individual who is (as determined
in accordance with section 262)--
(A) a covered individual who sustains a
covered injury in the manner described in
paragraph (3)(A); or
(B) an individual who sustains a covered
injury in the manner described in paragraph
(3)(B).
(7) Smallpox emergency response plan.--The term
``smallpox emergency response plan'' or ``plan'' means
a response plan detailing actions to be taken in
preparation for a possible smallpox-related emergency
during the period prior to the identification of an
active case of smallpox either within or outside the
United States.
(b) Voluntary Program.--The Secretary shall ensure that a
State, local, or Department of Health and Human Services plan
to vaccinate individuals that is approved by the Secretary
establishes procedures to ensure, consistent with the
Declaration and any applicable guidelines of the Centers for
Disease Control and Prevention, that--
(1) potential participants are educated with
respect to contraindications, the voluntary nature of
the program, and the availability of potential benefits
and compensation under this part;
(2) there is voluntary screening provided to
potential participants that can identify health
conditions relevant to contraindications; and
(3) there is appropriate post-inoculation medical
surveillance that includes an evaluation of adverse
health effects that may reasonably appear to be due to
such vaccine and prompt referral of, or the provision
of appropriate information to, any individual requiring
health care as a result of such adverse health event.
SEC. 262. [239A] DETERMINATION OF ELIGIBILITY AND BENEFITS.
(a) In General.--The Secretary shall establish procedures
for determining, as applicable with respect to an individual--
(1) whether the individual is an eligible
individual;
(2) whether an eligible individual has sustained a
covered injury or injuries for which medical benefits
or compensation may be available under sections 264 and
265, and the amount of such benefits or compensation;
and
(3) whether the covered injury or injuries of an
eligible individual caused the individual's death for
purposes of benefits under section 266.
(b) Covered Individuals.--The Secretary may accept a
certification, by a Federal, State, or local government entity
or private health care entity participating in the
administration of covered countermeasures under the
Declaration, that an individual is a covered individual.
(c) Criteria for Reimbursement.--
(1) Injuries specified in injury table.--In any
case where an injury or other adverse effect specified
in the injury table established under section 263 as a
known effect of a vaccine manifests in an individual
within the time period specified in such table, such
injury or other effect shall be presumed to have
resulted from administration of such vaccine.
(2) Other determinations.--In making determinations
other than those described in paragraph (1) as to the
causation or severity of an injury, the Secretary shall
employ a preponderance of the evidence standard and
take into consideration all relevant medical and
scientific evidence presented for consideration, and
may obtain and consider the views of qualified medical
experts.
(d) Deadline for Filing Request.--The Secretary shall not
consider any request for a benefit under this part with respect
to an individual, unless--
(1) in the case of a request based on the
administration of the vaccine to the individual, the
individual files with the Secretary an initial request
for benefits or compensation under this part not later
than one year after the date of administration of the
vaccine; or
(2) in the case of a request based on accidental
vaccinia inoculation, the individual files with the
Secretary an initial request for benefits or
compensation under this part not later than two years
after the date of the first symptom or manifestation of
onset of the adverse effect.
(e) Structured Settlements at Secretary's Option.--In any
case in which there is a reasonable likelihood that
compensation or payment under section 264, 265, or 266(b) will
be required for a period in excess of one year from the date an
individual is determined eligible for such compensation or
payment, the Secretary shall have the discretion to make a
lump-sum payment, purchase an annuity or medical insurance
policy, or execute an appropriate structured settlement
agreement, provided that such payment, annuity, policy, or
agreement is actuarially determined to have a value equal to
the present value of the projected total amount of benefits or
compensation that the individual is eligible to receive under
such section or sections.
(f) Review of Determination.--
(1) Secretary's review authority.--The Secretary
may review a determination under this section at any
time on the Secretary's own motion or on application,
and may affirm, vacate, or modify such determination in
any manner the Secretary deems appropriate. The
Secretary shall develop a process by which an
individual may file a request for reconsideration of
any determination made by the Secretary under this
section.
(2) Judicial and administrative review.--No court
of the United States, or of any State, District,
territory or possession thereof, shall have subject
matter jurisdiction to review, whether by mandamus or
otherwise, any action by the Secretary under this
section. No officer or employee of the United States
shall review any action by the Secretary under this
section (unless the President specifically directs
otherwise).
SEC. 263. [239B] SMALLPOX VACCINE INJURY TABLE.
(a) \1\ Smallpox Vaccine Injury Table.--
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\1\ Subsection (a) designation so in law. Section 263 does not
contain a subsection (b). See the amendment made by section 2 of Public
Law 108-20 (117 Stat. 638, 641), which added a new part C to title II.
---------------------------------------------------------------------------
(1) Establishment required.--The Secretary shall
establish by interim final regulation a table
identifying adverse effects (including injuries,
disabilities, illnesses, conditions, and deaths) that
shall be presumed to result from the administration of
(or exposure to) a smallpox vaccine, and the time
period in which the first symptom or manifestation of
onset of each such adverse effect must manifest in
order for such presumption to apply.
(2) Amendments.--The Secretary may by regulation
amend the table established under paragraph (1). An
amendment to the table takes effect on the date of the
promulgation of the final rule that makes the
amendment, and applies to all requests for benefits or
compensation under this part that are filed on or after
such date or are pending as of such date. In addition,
the amendment applies retroactively to an individual
who was not with respect to the injury involved an
eligible individual under the table as in effect before
the amendment but who with respect to such injury is an
eligible individual under the table as amended. With
respect to a request for benefits or compensation under
this part by an individual who becomes an eligible
individual as described in the preceding sentence, the
Secretary may not provide such benefits or compensation
unless the request (or amendment to a request, as
applicable) is filed before the expiration of one year
after the effective date of the amendment to the table
in the case of an individual to whom the vaccine was
administered and before the expiration of two years
after such effective date in the case of a request
based on accidental vaccinia inoculation.
SEC. 264. [239C] MEDICAL BENEFITS.
(a) In General.--Subject to the succeeding provisions of
this section, the Secretary shall make payment or reimbursement
for medical items and services as reasonable and necessary to
treat a covered injury of an eligible individual, including the
services, appliances, and supplies prescribed or recommended by
a qualified physician, which the Secretary considers likely to
cure, give relief, reduce the degree or the period of
disability, or aid in lessening the amount of monthly
compensation.
(b) Benefits Secondary to Other Coverage.--Payment or
reimbursement for services or benefits under subsection (a)
shall be secondary to any obligation of the United States or
any third party (including any State or local governmental
entity, private insurance carrier, or employer) under any other
provision of law or contractual agreement, to pay for or
provide such services or benefits.
SEC. 265. [239D] COMPENSATION FOR LOST EMPLOYMENT INCOME.
(a) In General.--Subject to the succeeding provisions of
this section, the Secretary shall provide compensation to an
eligible individual for loss of employment income (based on
such income at the time of injury) incurred as a result of a
covered injury, at the rate specified in subsection (b).
(b) Amount of Compensation.--
(1) In general.--Compensation under subsection (a)
shall be at the rate of 66\2/3\ percent of the relevant
pay period (weekly, monthly, or otherwise), except as
provided in paragraph (2).
(2) Augmented compensation for dependents.--If an
eligible individual has one or more dependents, the
basic compensation for loss of employment income as
described in paragraph (1) shall be augmented at the
rate of 8\1/3\ percent.
(3) Consideration of other programs.--
(A) In general.--The Secretary may consider
the provisions of sections 8114, 8115, and
8146a of title 5, United States Code, and any
implementing regulations, in determining the
amount of payment under subsection (a) and the
circumstances under which such payments are
reasonable and necessary.
(B) Minors.--With respect to an eligible
individual who is a minor, the Secretary may
consider the provisions of section 8113 of
title 5, United States Code, and any
implementing regulations, in determining the
amount of payment under subsection (a) and the
circumstances under which such payments are
reasonable and necessary.
(4) Treatment of self-employment income.--For
purposes of this section, the term ``employment
income'' includes income from self-employment.
(c) Limitations.--
(1) Benefits secondary to other coverage.--
(A) In general.--Any compensation under
subsection (a) shall be secondary to the
obligation of the United States or any third
party (including any State or local
governmental entity, private insurance carrier,
or employer), under any other law or
contractual agreement, to pay compensation for
loss of employment income or to provide
disability or retirement benefits.
(B) Relation to other obligations.--
Compensation under subsection (a) shall not be
made to an eligible individual to the extent
that the total of amounts paid to the
individual under such subsection and under the
other obligations referred to in subparagraph
(A) is an amount that exceeds the rate
specified in subsection (b)(1). If under any
such other obligation a lump-sum payment is
made, such payment shall, for purposes of this
paragraph, be deemed to be received over
multiple years rather than received in a single
year. The Secretary may, in the discretion of
the Secretary, determine how to apportion such
payment over multiple years.
(2) No benefits in case of death.--No payment shall
be made under subsection (a) in compensation for loss
of employment income subsequent to the receipt, by the
survivor or survivors of an eligible individual, of
benefits under section 266 for death.
(3) Limit on total benefits.--
(A) In general.--Except as provided in
subparagraph (B)--
(i) total compensation paid to an
individual under subsection (a) shall
not exceed $50,000 for any year; and
(ii) the lifetime total of such
compensation for the individual may not
exceed an amount equal to the amount
authorized to be paid under section
266.
(B) Permanent and total disability.--The
limitation under subparagraph (A)(ii) does not
apply in the case of an eligible individual who
is determined to have a covered injury or
injuries meeting the definition of disability
in section 216(i) of the Social Security Act
(42 U.S.C. 416(i)).
(4) Waiting period.--
(A) In general.--Except as provided in
subparagraph (B), an eligible individual shall
not be provided compensation under this section
for the first 5 work days of loss of employment
income.
(B) Exception.--Subparagraph (A) does not
apply if the period of loss of employment
income of an eligible individual is 10 or more
work days.
(5) Termination of benefits.--No payment shall be
made under subsection (a) in compensation for loss of
employment income once the eligible individual involves
reaches the age of 65.
(d) Benefit in Addition to Medical Benefits.--A benefit
under subsection (a) shall be in addition to any amounts
received by an eligible individual under section 264.
SEC. 266. [239E] PAYMENT FOR DEATH.
(a) Death Benefit.--
(1) In general.--The Secretary shall pay, in the
case of an eligible individual whose death is
determined to have resulted from a covered injury or
injuries, a death benefit in the amount determined
under paragraph (2) to the survivor or survivors in the
same manner as death benefits are paid pursuant to the
Public Safety Officers' Benefits Program under subpart
1 of part L of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with
respect to an eligible deceased (except that in the
case of an eligible individual who is a minor with no
living parent, the legal guardian shall be considered
the survivor in the place of the parent).
(2) Benefit amount.--
(A) In general.--The amount of the death
benefit under paragraph (1) in a fiscal year
shall equal the amount of the comparable
benefit calculated under the Public Safety
Officers' Benefits Program under subpart 1 of
part L of title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3796 et
seq.) in such fiscal year, without regard to
any reduction attributable to a limitation on
appropriations, but subject to subparagraph
(B).
(B) Reduction for payments for lost
employment income.--The amount of the benefit
as determined under subparagraph (A) shall be
reduced by the total amount of any benefits
paid under section 265 with respect to lost
employment income.
(3) Limitations.--
(A) In general.--No benefit is payable
under paragraph (1) with respect to the death
of an eligible individual if--
(i) a disability benefit is paid
with respect to such individual under
the Public Safety Officers' Benefits
Program under subpart 1 of part L of
title I of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C.
3796 et seq.); or
(ii) a death benefit is paid or
payable with respect to such individual
under the Public Safety Officers'
Benefits Program under subpart 1 of
part L of title I of the Omnibus Crime
Control and Safe Streets Act of 1968
(42 U.S.C. 3796 et seq.).
(B) Exception in the case of a limitation
on appropriations for disability benefits under
psob.--In the event that disability benefits
available to an eligible individual under the
Public Safety Officers' Benefits Program under
subpart 1 of part L of title I of the Omnibus
Crime Control and Safe Streets Act of 1968 (42
U.S.C. 3796 et seq.) are reduced because of a
limitation on appropriations, and such
reduction would affect the amount that would be
payable under subparagraph (A) without regard
to this subparagraph, benefits shall be
available under paragraph (1) to the extent
necessary to ensure that the survivor or
survivors of such individual receives a total
amount equal to the amount described in
paragraph (2).
(b) Election in Case of Dependents.--
(1) In general.--In the case of an eligible
individual whose death is determined to have resulted
from a covered injury or injuries, if the individual
had one or more dependents under the age of 18, the
legal guardian of the dependents may, in lieu of the
death benefit under subsection (a), elect to receive on
behalf of the aggregate of such dependents payments in
accordance with this subsection. An election under the
preceding sentence is effective in lieu of a request
under subsection (a) by an individual who is not the
legal guardian of such dependents.
(2) Amount of payments.--Payments under paragraph
(1) with respect to an eligible individual described in
such paragraph shall be made as if such individual were
an eligible individual to whom compensation would be
paid under subsection (a) of section 265, with the rate
augmented in accordance with subsection (b)(2) of such
section and with such individual considered to be an
eligible individual described in subsection (c)(3)(B)
of such section.
(3) Limitations.--
(A) Age of dependents.--No payments may be
made under paragraph (1) once the youngest of
the dependents involved reaches the age of 18.
(B) Benefits secondary to other coverage.--
(i) In general.--Any payment under
paragraph (1) shall be secondary to the
obligation of the United States or any
third party (including any State or
local governmental entity, private
insurance carrier, or employer), under
any other law or contractual agreement,
to pay compensation for loss of
employment income or to provide
disability benefits, retirement
benefits, life insurance benefits on
behalf of dependents under the age of
18, or death benefits.
(ii) Relation to other
obligations.--Payments under paragraph
(1) shall not be made to with respect
to an eligible individual to the extent
that the total of amounts paid with
respect to the individual under such
paragraph and under the other
obligations referred to in clause (i)
is an amount that exceeds the rate of
payment that applies under paragraph
(2). If under any such other obligation
a lump-sum payment is made, such
payment shall, for purposes of this
subparagraph, be deemed to be received
over multiple years rather than
received in a single year. The
Secretary may, in the discretion of the
Secretary, determine how to apportion
such payment over multiple years.
(c) Benefit in Addition to Medical Benefits.--A benefit
under subsection (a) or (b) shall be in addition to any amounts
received by an eligible individual under section 264.
SEC. 267. [239F] ADMINISTRATION.
(a) Administration by Agreement With Other Agency or
Agencies.--The Secretary may administer any or all of the
provisions of this part through Memorandum of Agreement with
the head of any appropriate Federal agency.
(b) Regulations.--The head of the agency administering this
part or provisions thereof (including any agency head
administering such Act or provisions through a Memorandum of
Agreement under subsection (a)) may promulgate such
implementing regulations as may be found necessary and
appropriate. Initial implementing regulations may be interim
final regulations.
SEC. 268. [239G] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2003 through 2007, to remain available
until expended, including administrative costs and costs of
provision and payment of benefits. The Secretary's payment of
any benefit under section 264, 265, or 266 shall be subject to
the availability of appropriations under this section.
SEC. 269. [239H] RELATIONSHIP TO OTHER LAWS.
Except as explicitly provided herein, nothing in this part
shall be construed to override or limit any rights an
individual may have to seek compensation, benefits, or redress
under any other provision of Federal or State law.
PART D--UNITED STATES PUBLIC HEALTH SCIENCES TRACK
SEC. 271. [239L] ESTABLISHMENT.
(a) United States Public Health Services Track.--
(1) In general.--There is hereby authorized to be
established a United States Public Health Sciences
Track (referred to in this part as the ``Track''), at
sites to be selected by the Secretary, with authority
to grant appropriate advanced degrees in a manner that
uniquely emphasizes team-based service, public health,
epidemiology, and emergency preparedness and response.
It shall be so organized as to graduate not less than--
(A) 150 medical students annually, 10 of
whom shall be awarded studentships to the
Uniformed Services University of Health
Sciences;
(B) 100 dental students annually;
(C) 250 nursing students annually;
(D) 100 public health students annually;
(E) 100 behavioral and mental health
professional students annually;
(F) 100 physician assistant or nurse
practitioner students annually; and
(G) 50 pharmacy students annually.
(2) Locations.--The Track shall be located at
existing and accredited, affiliated health professions
education training programs at academic health centers
located in regions of the United States determined
appropriate by the Surgeon General, in consultation
with the National Health Care Workforce Commission
established in section 5101 of the Patient Protection
and Affordable Care Act.
(b) Number of Graduates.--Except as provided in subsection
(a), the number of persons to be graduated from the Track shall
be prescribed by the Secretary. In so prescribing the number of
persons to be graduated from the Track, the Secretary shall
institute actions necessary to ensure the maximum number of
first-year enrollments in the Track consistent with the
academic capacity of the affiliated sites and the needs of the
United States for medical, dental, and nursing personnel.
(c) Development.--The development of the Track may be by
such phases as the Secretary may prescribe subject to the
requirements of subsection (a).
(d) Integrated Longitudinal Plan.--The Surgeon General
shall develop an integrated longitudinal plan for health
professions continuing education throughout the continuum of
health-related education, training, and practice. Training
under such plan shall emphasize patient-centered,
interdisciplinary, and care coordination skills. Experience
with deployment of emergency response teams shall be included
during the clinical experiences.
(e) Faculty Development.--The Surgeon General shall develop
faculty development programs and curricula in decentralized
venues of health care, to balance urban, tertiary, and
inpatient venues.
SEC. 272. [239L-1] ADMINISTRATION.
(a) In General.--The business of the Track shall be
conducted by the Surgeon General with funds appropriated for
and provided by the Department of Health and Human Services.
The National Health Care Workforce Commission shall assist the
Surgeon General in an advisory capacity.
(b) Faculty.--
(1) In general.--The Surgeon General, after
considering the recommendations of the National Health
Care Workforce Commission, shall obtain the services of
such professors, instructors, and administrative and
other employees as may be necessary to operate the
Track, but utilize when possible, existing affiliated
health professions training institutions. Members of
the faculty and staff shall be employed under salary
schedules and granted retirement and other related
benefits prescribed by the Secretary so as to place the
employees of the Track faculty on a comparable basis
with the employees of fully accredited schools of the
health professions within the United States.
(2) Titles.--The Surgeon General may confer
academic titles, as appropriate, upon the members of
the faculty.
(3) Nonapplication of provisions.--The limitations
in section 5373 of title 5, United States Code, shall
not apply to the authority of the Surgeon General under
paragraph (1) to prescribe salary schedules and other
related benefits.
(c) Agreements.--The Surgeon General may negotiate
agreements with agencies of the Federal Government to utilize
on a reimbursable basis appropriate existing Federal medical
resources located in the United States (or locations selected
in accordance with section 271(a)(2)). Under such agreements
the facilities concerned will retain their identities and basic
missions. The Surgeon General may negotiate affiliation
agreements with accredited universities and health professions
training institutions in the United States. Such agreements may
include provisions for payments for educational services
provided students participating in Department of Health and
Human Services educational programs.
(d) Programs.--The Surgeon General may establish the
following educational programs for Track students:
(1) Postdoctoral, postgraduate, and technological
programs.
(2) A cooperative program for medical, dental,
physician assistant, pharmacy, behavioral and mental
health, public health, and nursing students.
(3) Other programs that the Surgeon General
determines necessary in order to operate the Track in a
cost-effective manner.
(e) Continuing Medical Education.--The Surgeon General
shall establish programs in continuing medical education for
members of the health professions to the end that high
standards of health care may be maintained within the United
States.
(f) Authority of the Surgeon General.--
(1) In general.--The Surgeon General is
authorized--
(A) to enter into contracts with, accept
grants from, and make grants to any nonprofit
entity for the purpose of carrying out
cooperative enterprises in medical, dental,
physician assistant, pharmacy, behavioral and
mental health, public health, and nursing
research, consultation, and education;
(B) to enter into contracts with entities
under which the Surgeon General may furnish the
services of such professional, technical, or
clerical personnel as may be necessary to
fulfill cooperative enterprises undertaken by
the Track;
(C) to accept, hold, administer, invest,
and spend any gift, devise, or bequest of
personal property made to the Track, including
any gift, devise, or bequest for the support of
an academic chair, teaching, research, or
demonstration project;
(D) to enter into agreements with entities
that may be utilized by the Track for the
purpose of enhancing the activities of the
Track in education, research, and technological
applications of knowledge; and
(E) to accept the voluntary services of
guest scholars and other persons.
(2) Limitation.--The Surgeon General may not enter
into any contract with an entity if the contract would
obligate the Track to make outlays in advance of the
enactment of budget authority for such outlays.
(3) Scientists.--Scientists or other medical,
dental, or nursing personnel utilized by the Track
under an agreement described in paragraph (1) may be
appointed to any position within the Track and may be
permitted to perform such duties within the Track as
the Surgeon General may approve.
(4) Volunteer services.--A person who provides
voluntary services under the authority of subparagraph
(E) of paragraph (1) shall be considered to be an
employee of the Federal Government for the purposes of
chapter 81 of title 5, relating to compensation for
work-related injuries, and to be an employee of the
Federal Government for the purposes of chapter 171 of
title 28, relating to tort claims. Such a person who is
not otherwise employed by the Federal Government shall
not be considered to be a Federal employee for any
other purpose by reason of the provision of such
services.
SEC. 273. [239L-2] STUDENTS; SELECTION; OBLIGATION.
(a) Student Selection.--
(1) In general.--Medical, dental, physician
assistant, pharmacy, behavioral and mental health,
public health, and nursing students at the Track shall
be selected under procedures prescribed by the Surgeon
General. In so prescribing, the Surgeon General shall
consider the recommendations of the National Health
Care Workforce Commission.
(2) Priority.--In developing admissions procedures
under paragraph (1), the Surgeon General shall ensure
that such procedures give priority to applicant
medical, dental, physician assistant, pharmacy,
behavioral and mental health, public health, and
nursing students from rural communities and
underrepresented minorities.
(b) Contract and Service Obligation.--
(1) Contract.--Upon being admitted to the Track, a
medical, dental, physician assistant, pharmacy,
behavioral and mental health, public health, or nursing
student shall enter into a written contract with the
Surgeon General that shall contain--
(A) an agreement under which--
(i) subject to subparagraph (B),
the Surgeon General agrees to provide
the student with tuition (or tuition
remission) and a student stipend
(described in paragraph (2)) in each
school year for a period of years (not
to exceed 4 school years) determined by
the student, during which period the
student is enrolled in the Track at an
affiliated or other participating
health professions institution pursuant
to an agreement between the Track and
such institution; and
(ii) subject to subparagraph (B),
the student agrees--
(I) to accept the provision
of such tuition and student
stipend to the student;
(II) to maintain enrollment
at the Track until the student
completes the course of study
involved;
(III) while enrolled in
such course of study, to
maintain an acceptable level of
academic standing (as
determined by the Surgeon
General);
(IV) if pursuing a degree
from a school of medicine or
osteopathic medicine, dental,
public health, or nursing
school or a physician
assistant, pharmacy, or
behavioral and mental health
professional program, to
complete a residency or
internship in a specialty that
the Surgeon General determines
is appropriate; and
(V) to serve for a period
of time (referred to in this
part as the ``period of
obligated service'') within the
Commissioned Corps of the
Public Health Service equal to
2 years for each school year
during which such individual
was enrolled at the College,
reduced as provided for in
paragraph (3);
(B) a provision that any financial
obligation of the United States arising out of
a contract entered into under this part and any
obligation of the student which is conditioned
thereon, is contingent upon funds being
appropriated to carry out this part;
(C) a statement of the damages to which the
United States is entitled for the student's
breach of the contract; and
(D) such other statements of the rights and
liabilities of the Secretary and of the
individual, not inconsistent with the
provisions of this part.
(2) Tuition and student stipend.--
(A) Tuition remission rates.--The Surgeon
General, based on the recommendations of the
National Health Care Workforce Commission,
shall establish Federal tuition remission rates
to be used by the Track to provide
reimbursement to affiliated and other
participating health professions institutions
for the cost of educational services provided
by such institutions to Track students. The
agreement entered into by such participating
institutions under paragraph (1)(A)(i) shall
contain an agreement to accept as payment in
full the established remission rate under this
subparagraph.
(B) Stipend.--The Surgeon General, based on
the recommendations of the National Health Care
Workforce Commission, shall establish and
update Federal stipend rates for payment to
students under this part.
(3) Reductions in the period of obligated
service.--The period of obligated service under
paragraph (1)(A)(ii)(V) shall be reduced--
(A) in the case of a student who elects to
participate in a high-needs speciality
residency (as determined by the National Health
Care Workforce Commission), by 3 months for
each year of such participation (not to exceed
a total of 12 months); and
(B) in the case of a student who, upon
completion of their residency, elects to
practice in a Federal medical facility (as
defined in section 781(e)) that is located in a
health professional shortage area (as defined
in section 332), by 3 months for year of full-
time practice in such a facility (not to exceed
a total of 12 months).
(c) Second 2 Years of Service.--During the third and fourth
years in which a medical, dental, physician assistant,
pharmacy, behavioral and mental health, public health, or
nursing student is enrolled in the Track, training should be
designed to prioritize clinical rotations in Federal medical
facilities in health professional shortage areas, and emphasize
a balance of hospital and community-based experiences, and
training within interdisciplinary teams.
(d) Dentist, Physician Assistant, Pharmacist, Behavioral
and Mental Health Professional, Public Health Professional, and
Nurse Training.--The Surgeon General shall establish provisions
applicable with respect to dental, physician assistant,
pharmacy, behavioral and mental health, public health, and
nursing students that are comparable to those for medical
students under this section, including service obligations,
tuition support, and stipend support. The Surgeon General shall
give priority to health professions training institutions that
train medical, dental, physician assistant, pharmacy,
behavioral and mental health, public health, and nursing
students for some significant period of time together, but at a
minimum have a discrete and shared core curriculum.
(e) Elite Federal Disaster Teams.--The Surgeon General, in
consultation with the Secretary, the Director of the Centers
for Disease Control and Prevention, and other appropriate
military and Federal government agencies, shall develop
criteria for the appointment of highly qualified Track faculty,
medical, dental, physician assistant, pharmacy, behavioral and
mental health, public health, and nursing students, and
graduates to elite Federal disaster preparedness teams to train
and to respond to public health emergencies, natural disasters,
bioterrorism events, and other emergencies.
(f) Student Dropped From Track in Affiliate School.--A
medical, dental, physician assistant, pharmacy, behavioral and
mental health, public health, or nursing student who, under
regulations prescribed by the Surgeon General, is dropped from
the Track in an affiliated school for deficiency in conduct or
studies, or for other reasons, shall be liable to the United
States for all tuition and stipend support provided to the
student.
SEC. 274. [239L-3] FUNDING.
Beginning with fiscal year 2010, the Secretary shall
transfer from the Public Health and Social Services Emergency
Fund such sums as may be necessary to carry out this
part.3/1/01 9:05:59 AM - F:\V7\030101\030101.005
Created by: PMG deg.ATTORNEY: PMG/FD (May 26,
1999) deg.
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
Part A--Research and Investigation
in general
Sec. 301. [241] (a) The Secretary shall conduct in the
Service, and encourage, cooperate with, and render assistance
to other appropriate public authorities, scientific
institutions, and scientists in the conduct of, and promote the
coordination of, research, investigations, experiments,
demonstrations, and studies relating to the causes, diagnosis,
treatment, control, and prevention of physical and mental
diseases and impairments of man, including water purification,
sewage treatment, and pollution of lakes and streams. In
carrying out the foregoing the Secretary is authorized to--
(1) collect and make available through publications
and other appropriate means, information as to, and the
practical application of, such research and other
activities;
(2) make available research facilities of the
Service to appropriate public authorities, and to
health officials and scientists engaged in special
study;
(3) make grants-in-aid to universities, hospitals,
laboratories, and other public or private institutions,
and to individuals for such research projects as are
recommended by the advisory council to the entity of
the Department supporting such projects and make, upon
recommendation of the advisory council to the
appropriate entity of the Department, grants-in-aid to
public or nonprofit universities, hospitals,
laboratories, and other institutions for the general
support of their research;
(4) secure from time to time and for such periods
as he deems advisable, the assistance and advice of
experts, scholars, and consultants from the United
States or abroad;
(5) for purposes of study, admit and treat at
institutions, hospitals, and stations of the Service,
persons not otherwise eligible for such treatment;
(6) make available, to health officials,
scientists, and appropriate public and other nonprofit
institutions and organizations, technical advice and
assistance on the application of statistical methods to
experiments, studies, and surveys in health and medical
fields;
(7) enter into contracts, including contracts for
research in accordance with and subject to the
provisions of law applicable to contracts entered into
by the military departments under title 10, United
States Code, sections 2353 and 2354, except that
determination, approval, and certification required
thereby shall be by the Secretary of Health, Education,
and Welfare; and
(8) adopt, upon recommendations of the advisory
councils to the appropriate entities of the Department
or, with respect to mental health, the National
Advisory Mental Health Council, such additional means
as the Secretary considers necessary or appropriate to
carry out the purposes of this section.
The Secretary may make available to individuals and entities,
for biomedical and behavioral research, substances and living
organisms. Such substances and organisms shall be made
available under such terms and conditions (including payment
for them) as the Secretary determines appropriate.
(b)(1) The Secretary shall conduct and may support through
grants and contracts studies and testing of substances for
carcinogenicity, teratogenicity, mutagenicity, and other
harmful biological effects. In carrying out this paragraph, the
Secretary shall consult with entities of the Federal
Government, outside of the Department of Health, Education, and
Welfare, engaged in comparable activities. The Secretary, upon
request of such an entity and under appropriate arrangements
for the payment of expenses, may conduct for such entity
studies and testing of substances for carcinogenicity,
teratogenicity, mutagenicity, and other harmful biological
effects.
(2)(A) The Secretary shall establish a comprehensive
program of research into the biological effects of low-level
ionizing radiation under which program the Secretary shall
conduct such research and may support such research by others
through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of
Federal programs of research on the biological effects of
ionizing radiation.
(3) The Secretary shall conduct and may support through
grants and contracts research and studies on human nutrition,
with particular emphasis on the role of nutrition in the
prevention and treatment of disease and on the maintenance and
promotion of health, and programs for the dissemination of
information respecting human nutrition to health professionals
and the public. In carrying out activities under this
paragraph, the Secretary shall provide for the coordination of
such of these activities as are performed by the different
divisions within the Department of Health, Education, and
Welfare and shall consult with entities of the Federal
Government, outside of the Department of Health, Education, and
Welfare, engaged in comparable activities. The Secretary, upon
request of such an entity and under appropriate arrangements
for the payment of expenses, may conduct and support such
activities for such entity.
(4) The Secretary shall publish a biennial report which
contains--
(A) a list of all substances (i) which either are
known to be carcinogens or may reasonably be
anticipated to be carcinogens and (ii) to which a
significant number of persons residing in the United
States are exposed;
(B) information concerning the nature of such
exposure and the estimated number of persons exposed to
such substances;
(C) a statement identifying (i) each substance
contained in the list under subparagraph (A) for which
no effluent, ambient, or exposure standard has been
established by a Federal agency, and (ii) for each
effluent, ambient, or exposure standard established by
a Federal agency with respect to a substance contained
in the list under subparagraph (A), the extent to
which, on the basis of available medical, scientific,
or other data, such standard, and the implementation of
such standard by the agency, decreases the risk to
public health from exposure to the substance; and
(D) a description of (i) each request received
during the year involved--
(I) from a Federal agency outside the
Department of Health, Education, and Welfare
for the Secretary, or
(II) from an entity within the Department
of Health, Education, and Welfare to any other
entity within the Department,
to conduct research into, or testing for, the
carcinogenicity of substances or to provide information
described in clause (ii) of subparagraph (C), and (ii)
how the Secretary and each such other entity,
respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any
contract for the conduct of any study, testing, program,
research, or review, or assessment under this subsection shall
be effective for any fiscal year only to such extent or in such
amounts as are provided in advance in Appropriation Acts.
(c) The Secretary may conduct biomedical research,
directly or through grants or contracts, for the
identification, control, treatment, and prevention of diseases
(including tropical diseases) which do not occur to a
significant extent in the United States.
(d) The Secretary may authorize persons engaged in
biomedical, behavioral, clinical, or other research (including
research on mental health, including research on the use and
effect of alcohol and other psychoactive drugs) to protect the
privacy of individuals who are the subject of such research by
withholding from all persons not connected with the conduct of
such research the names or other identifying characteristics of
such individuals. Persons so authorized to protect the privacy
of such individuals may not be compelled in any Federal, State,
or local civil, criminal, administrative, legislative, or other
proceedings to identify such individuals.
(e) The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall expand,
intensify, and coordinate the activities of the Centers for
Disease Control and Prevention with respect to preterm labor
and delivery and infant mortality.
narcotics
Sec. 302. [242] (a) In carrying out the purposes of section
301 with respect to drugs the use or misuse of which might
result in drug abuse or dependency, the studies and
investigations authorized therein shall include the use and
misuse of narcotic drugs and other drugs. Such studies and
investigations shall further include the quantities of crude
opium, coca leaves, and their salts, derivatives, and
preparations, and other drugs subject to control under the
Controlled Substances Act and Controlled Substances Import and
Export Act, together with reserves thereof, necessary to supply
the normal and emergency medicinal and scientific requirements
of the United States. The results of studies and investigations
of the quantities of narcotic drugs or other drugs subject to
control under such Acts, together with reserves of such drugs,
that are necessary to supply the normal and emergency medicinal
and scientific requirements of the United States, shall be
reported not later than the first day of April of each year to
the Attorney General, to be used at his discretion in
determining manufacturing quotas or importation requirements
under such Acts.
(b) The Surgeon General shall cooperate with States for the
purpose of aiding them to solve their narcotic drug problems
and shall give authorized representatives of the States the
benefit of his experience in the care, treatment, and
rehabilitation of narcotic addicts to the end that each State
may be encouraged to provide adequate facilities and methods
for the care and treatment of its narcotic addicts.
general authority respecting research, evaluations, and demonstrations
in health statistics, health services, and health care technology
assessment
Sec. 304. \1\ [242b] (a) The Secretary may, through the
Agency for Health Care Policy and Research or the National
Center for Health Statistics or using National Research Service
Awards or other appropriate authorities, undertake and support
training programs to provide for an expanded and continuing
supply of individuals qualified to perform the research,
evaluation, and demonstration projects set forth in section 306
and in title IX.
---------------------------------------------------------------------------
\1\ Former section 303 was repealed by section 3201(b)(1) of Public
Law 106-310 (114 Stat. 1190).
---------------------------------------------------------------------------
(b) To implement subsection (a) and section 306, the
Secretary may, in addition to any other authority which under
other provisions of this Act or any other law may be used by
him to implement such subsection, do the following:
(1) Utilize personnel and equipment, facilities,
and other physical resources of the Department of
Health and Human Services, permit appropriate (as
determined by the Secretary) entities and individuals
to utilize the physical resources of such Department,
provide technical assistance and advice, make grants to
public and nonprofit private entities and individuals,
and, when appropriate, enter into contracts with public
and private entities and individuals.
(2) Admit and treat at hospitals and other
facilities of the Service persons not otherwise
eligible for admission and treatment at such
facilities.
(3) Secure, from time to time and for such periods
as the Secretary deems advisable but in accordance with
section 3109 of title 5, United States Code, the
assistance and advice of consultants from the United
States or abroad. The Secretary may for the purpose of
carrying out the functions set forth in sections 305,
\2\ 306, and 309, obtain (in accordance with section
3109 of title 5 of the United States Code, but without
regard to the limitation in such section on the number
of days or the period of service) for each of the
centers the services of not more than fifteen experts
who have appropriate scientific or professional
qualifications.
---------------------------------------------------------------------------
\2\ See footnote for section 306.
---------------------------------------------------------------------------
(4) Acquire, construct, improve, repair, operate,
and maintain laboratory, research, and other necessary
facilities and equipment, and such other real or
personal property (including patents) as the Secretary
deems necessary; and acquire, without regard to the Act
of March 3, 1877 (40 U.S.C. 34), by lease or otherwise,
through the Administrator of General Services,
buildings or parts of buildings in the District of
Columbia or communities located adjacent to the
District of Columbia.
(c)(1) The Secretary shall coordinate all health services
research, evaluations, and demonstrations, all health
statistical and epidemiological activities, and all research,
evaluations, and demonstrations respecting the assessment of
health care technology undertaken and supported through units
of the Department of Health and Human Services. To the maximum
extent feasible such coordination shall be carried out through
the Agency for Health Care Policy and Research and the National
Center for Health Statistics.
(2) The Secretary shall coordinate the health services
research, evaluations, and demonstrations, the health
statistical and (where appropriate) epidemiological activities,
and the research, evaluations, and demonstrations respecting
the assessment of health care technology authorized by this Act
through the Agency for Health Care Policy and Research and the
National Center for Health Statistics.
national center for health statistics
Sec. 306. \1\ [242k] (a) There is established in the
Department of Health and Human Services the National Center for
Health Statistics (hereinafter in this section referred to as
the ``Center'') which shall be under the direction of a
Director who shall be appointed by the Secretary. The
Secretary, acting through the Center, shall conduct and support
statistical and epidemiological activities for the purpose of
improving the effectiveness, efficiency, and quality of health
services in the United States.
---------------------------------------------------------------------------
\1\ Former section 305 was repealed by section 6103(d)(1)(A) of
Public Law 101-239 (103 Stat. 2205). Title IX now applies to the matter
with which former section 305 was concerned.
---------------------------------------------------------------------------
(b) In carrying out subsection (a), the Secretary, acting
through the Center--
(1) shall collect statistics on--
(A) the extent and nature of illness and
disability of the population of the United
States (or of any groupings of the people
included in the population), including life
expectancy, the incidence of various acute and
chronic illnesses, and infant and maternal
morbidity and mortality,
(B) the impact of illness and disability of
the population on the economy of the United
States and on other aspects of the well-being
of its population (or of such groupings),
(C) environmental, social, and other health
hazards,
(D) determinants of health,
(E) health resources, including physicians,
dentists, nurses, and other health
professionals by specialty and type of practice
and the supply of services by hospitals,
extended care facilities, home health agencies,
and other health institutions,
(F) utilization of health care, including
utilization of (i) ambulatory health services
by specialties and types of practice of the
health professionals providing such services,
and (ii) services of hospitals, extended care
facilities, home health agencies, and other
institutions,
(G) health care costs and financing,
including the trends in health care prices and
cost, the sources of payments for health care
services, and Federal, State, and local
governmental expenditures for health care
services, and
(H) family formation, growth, and
dissolution;
(2) shall undertake and support (by grant or
contract) research, demonstrations, and evaluations
respecting new or improved methods for obtaining
current data on the matters referred to in paragraph
(1);
(3) may undertake and support (by grant or
contract) epidemiological research, demonstrations, and
evaluations on the matters referred to in paragraph
(1); and
(4) may collect, furnish, tabulate, and analyze
statistics, and prepare studies, on matters referred to
in paragraph (1) upon request of public and nonprofit
private entities under arrangements under which the
entities will pay the cost of the service provided.
Amounts appropriated to the Secretary from payments made under
arrangements made under paragraph (4) shall be available to the
Secretary for obligation until expended.
(c) The Center shall furnish such special statistical and
epidemiological compilations and surveys as the Committee on
Labor and Human Resources and the Committee on Appropriations
of the Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives may
request. Such statistical and epidemiological compilations and
surveys shall not be made subject to the payment of the actual
or estimated cost of the preparation of such compilations and
surveys.
(d) To insure comparability and reliability of health
statistics, the Secretary shall, through the Center, provide
adequate technical assistance to assist State and local
jurisdictions in the development of model laws dealing with
issues of confidentiality and comparability of data.
(e) For the purpose of producing comparable and uniform
health information and statistics, there is established the
Cooperative Health Statistics System. The Secretary, acting
through the Center, shall--
(1) coordinate the activities of Federal agencies
involved in the design and implementation of the
System;
(2) undertake and support (by grant or contract)
research, development, demonstrations, and evaluations
respecting the System;
(3) make grants to and enter into contracts with
State and local health agencies to assist them in
meeting the costs of data collection and other
activities carried out under the System; and
(4) review the statistical activities of the
Department of Health and Human Services to assure that
they are consistent with the System.
States participating in the System shall designate a State
agency to administer or be responsible for the administration
of the statistical activities within the State under the
System. The Secretary, acting through the Center, shall
prescribe guidelines to assure that statistical activities
within States participating in the system \1\ produce uniform
and timely data and assure appropriate access to such data.
---------------------------------------------------------------------------
\1\ So in law. Probably should be capitalized.
---------------------------------------------------------------------------
(f) To assist in carrying out this section, the Secretary,
acting through the Center, shall cooperate and consult with the
Departments of Commerce and Labor and any other interested
Federal departments or agencies and with State and local health
departments and agencies. For such purpose he shall utilize
insofar as possible the services or facilities of any agency of
the Federal Government and, without regard to section 3709 of
the Revised Statutes (41 U.S.C. 5), of any appropriate State or
other public agency, and may, without regard to such section,
utilize the services or facilities of any private agency,
organization, group, or individual, in accordance with written
agreements between the head of such agency, organization, or
group and the Secretary or between such individual and the
Secretary. Payment, if any, for such services or facilities
shall be made in such amounts as may be provided in such
agreement.
(g) To secure uniformity in the registration and collection
of mortality, morbidity, and other health data, the Secretary
shall prepare and distribute suitable and necessary forms for
the collection and compilation of such data.
(h)(1) There shall be an annual collection of data from the
records of births, deaths, marriages, and divorces in
registration areas. The data shall be obtained only from and
restricted to such records of the States and municipalities
which the Secretary, in his discretion, determines possess
records affording satisfactory data in necessary detail and
form. The Secretary shall encourage States and registration
areas to obtain detailed data on ethnic and racial populations,
including subpopulations of Hispanics, Asian Americans, and
Pacific Islanders with significant representation in the State
or registration area. Each State or registration area shall be
paid by the Secretary the Federal share of its reasonable costs
(as determined by the Secretary) for collecting and
transcribing (at the request of the Secretary and by whatever
method authorized by him) its records for such data.
(2) There shall be an annual collection of data from a
statistically valid sample concerning the general health,
illness, and disability status of the civilian
noninstitutionalized population. Specific topics to be
addressed under this paragraph, on an annual or periodic basis,
shall include the incidence of illness and accidental injuries,
prevalence of chronic diseases and impairments, disability,
physician visits, hospitalizations, and the relationship
between demographic and socioeconomic characteristics and
health characteristics.
(i) The Center may provide to public and nonprofit private
entities technical assistance in the effective use in such
activities of statistics collected or compiled by the Center.
(j) In carrying out the requirements of section 304(c) and
paragraph (1) of subsection (e) of this section, the Secretary
shall coordinate health statistical and epidemiological
activities of the Department of Health and Human Services by--
(1) establishing standardized means for the
collection of health information and statistics under
laws administered by the Secretary;
(2) developing, in consultation with the National
Committee on Vital and Health Statistics, and
maintaining the minimum sets of data needed on a
continuing basis to fulfill the collection requirements
of subsection (b)(1);
(3) after consultation with the National Committee
on Vital and Health Statistics, establishing standards
to assure the quality of health statistical and
epidemiological data collection, processing, and
analysis;
(4) in the case of proposed health data collections
of the Department which are required to be reviewed by
the Director of the Office of Management and Budget
under section 3509 of title 44, United States Code,
reviewing such proposed collections to determine
whether they conform with the minimum sets of data and
the standards promulgated pursuant to paragraphs (2)
and (3), and if any such proposed collection is found
not to be in conformance, by taking such action as may
be necessary to assure that it will conform to such
sets of data and standards, and
(5) periodically reviewing ongoing health data
collections of the Department, subject to review under
such section 3509, to determine if the collections are
being conducted in accordance with the minimum sets of
data and the standards promulgated pursuant to
paragraphs (2) and (3) and, if any such collection is
found not to be in conformance, by taking such action
as may be necessary to assure that the collection will
conform to such sets of data and standards not later
than the nineteenth day after the date of the
completion of the review of the collection.
(k)(1) There is established in the Office of the Secretary
a committee to be known as the National Committee on Vital and
Health Statistics (hereinafter in this subsection, referred to
as the ``Committee'') which shall consist of 18 members.
(2) The members of the Committee shall be appointed from
among persons who have distinguished themselves in the fields
of health statistics, electronic interchange of health care
information, privacy and security of electronic information,
population-based public health, purchasing or financing health
care services, integrated computerized health information
systems, health services research, consumer interests in health
information, health data standards, epidemiology, and the
provision of health services. Members of the Committee shall be
appointed for terms of 4 years.
(3) Of the members of the Committee--
(A) 1 shall be appointed, not later than 60 days
after the date of the enactment of the Health Insurance
Portability and Accountability Act of 1996, by the
Speaker of the House of Representatives after
consultation with the Minority Leader of the House of
Representatives;
(B) 1 shall be appointed, not later than 60 days
after the date of the enactment of the Health Insurance
Portability and Accountability Act of 1996, by the
President pro tempore of the Senate after consultation
with the Minority Leader of the Senate; and
(C) 16 shall be appointed by the Secretary.
(4) Members of the Committee shall be compensated in
accordance with section 208(c).
(5) The Committee--
(A) shall assist and advise the Secretary--
(i) to delineate statistical problems
bearing on health and health services which are
of national or international interest;
(ii) to stimulate studies of such problems
by other organizations and agencies whenever
possible or to make investigations of such
problems through subcommittees;
(iii) to determine, approve, and revise the
terms, definitions, classifications, and
guidelines for assessing health status and
health services, their distribution and costs,
for use (I) within the Department of Health and
Human Services, (II) by all programs
administered or funded by the Secretary,
including the Federal-State-local cooperative
health statistics system referred to in
subsection (e), and (III) to the extent
possible as determined by the head of the
agency involved, by the Department of Veterans
Affairs, the Department of Defense, and other
Federal agencies concerned with health and
health services;
(iv) with respect to the design of and
approval of health statistical and health
information systems concerned with the
collection, processing, and tabulation of
health statistics within the Department of
Health and Human Services, with respect to the
Cooperative Health Statistics System
established under subsection (e), and with
respect to the standardized means for the
collection of health information and statistics
to be established by the Secretary under
subsection (j)(1);
(v) to review and comment on findings and
proposals developed by other organizations and
agencies and to make recommendations for their
adoption or implementation by local, State,
national, or international agencies;
(vi) to cooperate with national committees
of other countries and with the World Health
Organization and other national agencies in the
studies of problems of mutual interest;
(vii) to issue an annual report on the
state of the Nation's health, its health
services, their costs and distributions, and to
make proposals for improvement of the Nation's
health statistics and health information
systems; and
(viii) in complying with the requirements
imposed on the Secretary under part C of title
XI of the Social Security Act;
(B) shall study the issues related to the adoption
of uniform data standards for patient medical record
information and the electronic exchange of such
information;
(C) shall report to the Secretary not later than 4
years after the date of the enactment of the Health
Insurance Portability and Accountability Act of 1996
recommendations and legislative proposals for such
standards and electronic exchange; and
(D) shall be responsible generally for advising the
Secretary and the Congress on the status of the
implementation of part C of title XI of the Social
Security Act.
(6) In carrying out health statistical activities under
this part, the Secretary shall consult with, and seek the
advice of, the Committee and other appropriate professional
advisory groups.
(7) Not later than 1 year after the date of the enactment
of the Health Insurance Portability and Accountability Act of
1996, and annually thereafter, the Committee shall submit to
the Congress, and make public, a report regarding the
implementation of part C of title XI of the Social Security
Act. Such report shall address the following subjects, to the
extent that the Committee determines appropriate:
(A) The extent to which persons required to comply
with part C of title XI of the Social Security Act are
cooperating in implementing the standards adopted under
such part.
(B) The extent to which such entities are meeting
the security standards adopted under such part and the
types of penalties assessed for noncompliance with such
standards.
(C) Whether the Federal and State Governments are
receiving information of sufficient quality to meet
their responsibilities under such part.
(D) Any problems that exist with respect to
implementation of such part.
(E) The extent to which timetables under such part
are being met.
(l) In carrying out this section, the Secretary, acting
through the Center, shall collect and analyze adequate health
data that is specific to particular ethnic and racial
populations, including data collected under national health
surveys. Activities carried out under this subsection shall be
in addition to any activities carried out under subsection (m).
(m)(1) The Secretary, acting through the Center, may make
grants to public and nonprofit private entities for--
(A) the conduct of special surveys or studies on
the health of ethnic and racial populations or
subpopulations;
(B) analysis of data on ethnic and racial
populations and subpopulations; and
(C) research on improving methods for developing
statistics on ethnic and racial populations and
subpopulations.
(2) The Secretary, acting through the Center, may provide
technical assistance, standards, and methodologies to grantees
supported by this subsection in order to maximize the data
quality and comparability with other studies.
(3) Provisions of section 308(d) do not apply to surveys or
studies conducted by grantees under this subsection unless the
Secretary, in accordance with regulations the Secretary may
issue, determines that such provisions are necessary for the
conduct of the survey or study and receives adequate assurance
that the grantee will enforce such provisions.
(4)(A) Subject to subparagraph (B), the Secretary, acting
through the Center, shall collect data on Hispanics and major
Hispanic subpopulation groups and American Indians, and for
developing special area population studies on major Asian
American and Pacific Islander populations.
(B) The provisions of subparagraph (A) shall be effective
with respect to a fiscal year only to the extent that funds are
appropriated pursuant to paragraph (3) of subsection (n), and
only if the amounts appropriated for such fiscal year pursuant
to each of paragraphs (1) and (2) of subsection (n) equal or
exceed the amounts so appropriated for fiscal year 1997.
(n)(1) For health statistical and epidemiological
activities undertaken or supported under subsections (a)
through (l), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1991 through
2003.
(2) For activities authorized in paragraphs (1) through (3)
of subsection (m), there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 1999
through 2003. Of such amounts, the Secretary shall use not more
than 10 percent for administration and for activities described
in subsection (m)(2).
(3) For activities authorized in subsection (m)(4), there
are authorized to be appropriated $1,000,000 for fiscal year
1998, and such sums as may be necessary for each of the fiscal
years 1999 through 2002.
international cooperation
Sec. 307. [242l] (a) The Secretary may participate with
other countries in cooperative endeavors in--
(1) biomedical research, health care technology,
and the health services research and statistical
analysis authorized under section 306 and title IX; and
(2) biomedical research, health care services,
health care research, or other related activities in
furtherance of the activities, objectives or goals
authorized under the Tom Lantos and Henry J. Hyde
United States Global Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Reauthorization Act of 2008.
(b) In connection with the cooperative endeavors authorized
by subsection (a), the Secretary may--
(1) make such use of resources offered by
participating foreign countries as he may find
necessary and appropriate;
(2) establish and maintain fellowships in the
United States and in participating foreign countries;
(3) make grants to public institutions or agencies
and to nonprofit private institutions or agencies in
the United States and in participating foreign
countries for the purpose of establishing and
maintaining the fellowships authorized by paragraph
(2);
(4) make grants or loans of equipment and
materials, for use by public or nonprofit private
institutions or agencies, or by individuals, in
participating foreign countries;
(5) participate and otherwise cooperate in any
international meetings, conferences, or other
activities concerned with biomedical research, health
services research, health statistics, or health care
technology;
(6) facilitate the interchange between the United
States and participating foreign countries, and among
participating foreign countries, of research scientists
and experts who are engaged in experiments or programs
of biomedical research, health services research,
health statistical activities, or health care
technology activities, and in carrying out such purpose
may pay per diem compensation, subsistence, and travel
for such scientists and experts when away from their
places of residence at rates not to exceed those
provided in section 5703(b) of title 5, United States
Code, for persons in the Government service employed
intermittently;
(7) procure, in accordance with section 3109 of
title 5, United States Code, the temporary or
intermittent services of experts or consultants;
(8) enter into contracts with individuals for the
provision of services (as defined in section 104 of
part 37 of title 48, Code of Federal Regulations (48
CFR 37.104)) in participating foreign countries, which
individuals may not be deemed employees of the United
States for the purpose of any law administered by the
Office of Personnel Management;
(9) provide such funds by advance or reimbursement
to the Secretary of State, as may be necessary, to pay
the costs of acquisition, lease, construction,
alteration, equipping, furnishing or management of
facilities outside of the United States; and
(10) in consultation with the Secretary of State,
through grant or cooperative agreement, make funds
available to public or nonprofit private institutions
or agencies in foreign countries in which the Secretary
is participating in activities described under
subsection (a) to acquire, lease, construct, alter, or
renovate facilities in those countries.
(c) The Secretary may provide to personnel appointed or
assigned by the Secretary to serve abroad, allowances and
benefits similar to those provided under chapter 9 of title I
of the Foreign Service Act of 1980 (22 U.S.C. 4081 et seq.).
Leaves of absence for personnel under this subsection shall be
on the same basis as that provided under subchapter I of
chapter 63 of title 5, United States Code or section 903 of the
Foreign Service Act of 1980 (22 U.S.C. 4083), to individuals
serving in the Foreign Service.
(d) In carrying out immunization programs and other
programs in developing countries for the prevention, treatment,
and control of infectious diseases, including HIV/AIDS,
tuberculosis, and malaria, the Director of the Centers for
Disease Control and Prevention, in coordination with the
Coordinator of United States Government Activities to Combat
HIV/AIDS Globally, the National Institutes of Health, national
and local government, and other organizations, such as the
World Health Organization and the United Nations Children's
Fund, shall develop and implement effective strategies to
improve injection safety, including eliminating unnecessary
injections, promoting sterile injection practices and
technologies, strengthening the procedures for proper needle
and syringe disposal, and improving the education and
information provided to the public and to health professionals.
general provisions respecting effectiveness, efficiency, and quality of
health services
Sec. 308. [242m] (a)(1) Not later than March 15 of each
year, the Secretary shall submit to the President and Congress
the following reports:
(A) A report on health care costs and financing.
Such report shall include a description and analysis of
the statistics collected under section 306(b)(1)(G).
(B) A report on health resources. Such report shall
include a description and analysis, by geographical
area, of the statistics collected under section
306(b)(1)(E).
(C) A report on the utilization of health
resources. Such report shall include a description and
analysis, by age, sex, income, and geographic area, of
the statistics collected under section 306(b)(1)(F).
(D) A report on the health of the Nation's people.
Such report shall include a description and analysis,
by age, sex, income, and geographic area, of the
statistics collected under section 306(b)(1)(A).
(2) The reports required in paragraph (1) shall be prepared
through the National Center for Health Statistics.
(3) The Office of Management and Budget may review any
report required by paragraph (1) of this subsection before its
submission to Congress, but the Office may not revise any such
report or delay its submission beyond the date prescribed for
its submission, and may submit to Congress its comments
respecting any such report.
(b)(1) No grant or contract may be made under section 304,
306, or 307 unless an application therefor has been submitted
to the Secretary in such form and manner, and containing such
information, as the Secretary may by regulation prescribe and
unless a peer review group referred to in paragraph (2) has
recommended the application for approval.
(2)(A) Each application submitted for a grant or contract
under section 306 in an amount exceeding $50,000 of direct
costs and for a health services research, evaluation, or
demonstration project, or for a grant under section 306(m),
shall be submitted to a peer review group for an evaluation of
the technical and scientific merits of the proposals made in
each such application. The Director of the National Center for
Health Statistics shall establish such peer review groups as
may be necessary to provide for such an evaluation of each such
application.
(B) A peer review group to which an application is
submitted pursuant to subparagraph (A) shall report its finding
and recommendations respecting the application to the
Secretary, acting through the Director of the National Center
for Health Statistics, in such form and manner as the Secretary
shall by regulation prescribe. The Secretary may not approve an
application described in such subparagraph unless a peer review
group has recommended the application for approval.
(C) The Secretary, acting through the Director of the
National Center for Health Statistics, shall make appointments
to the peer review groups required in subparagraph (A) from
among persons who are not officers or employees of the United
States and who possess appropriate technical and scientific
qualifications, except that peer review groups regarding grants
under section 306(m) may include appropriately qualified such
officers and employees.
(c) The Secretary shall take such action as may be
necessary to assure that statistics developed under sections
304 and 306 are of high quality, timely, comprehensive as well
as specific, standardized, and adequately analyzed and indexed,
and shall publish, make available, and disseminate such
statistics on as wide a basis as is practicable.
(d) No information, if an establishment or person supplying
the information or described in it is identifiable, obtained in
the course of activities undertaken or supported under section
304, 306, or 307 may be used for any purpose other than the
purpose for which it was supplied unless such establishment or
person has consented (as determined under regulations of the
Secretary) to its use for such other purpose and in the case of
information obtained in the course of health statistical or
epidemiological activities under section 304 or 306, such
information may not be published or released in other form if
the particular establishment or person supplying the
information or described in it is identifiable unless such
establishment or person has consented (as determined under
regulations of the Secretary) to its publication or release in
other form.
(e)(1) Payments of any grant or under any contract under
section 304, 306, or 307 may be made in advance or by way of
reimbursement, and in such installments and on such conditions,
as the Secretary deems necessary to carry out the purposes of
such section.
(2) The amounts otherwise payable to any person under a
grant or contract made under section 304, 306, or 307 shall be
reduced by--
(A) amounts equal to the fair market value of any
equipment or supplies furnished to such person by the
Secretary for the purpose of carrying out the project
with respect to which such grant or contract is made,
and
(B) amounts equal to the pay, allowances, traveling
expenses, and related personnel expenses attributable
to the performance of services by an officer or
employee of the Government in connection with such
project, if such officer or employee was assigned or
detailed by the Secretary to perform such services,
but only if such person requested the Secretary to furnish such
equipment or supplies, or such services, as the case may be.
(f) Contracts may be entered into under section 304 or 306
without regard to section 3324 of title 31, United States Code,
and section 3709 of the Revised Statutes (41 U.S.C. 5).
health conferences and health education information
Sec. 310. \1\ [242o] (a) A conference of the health
authorities in and among the several States shall be called
annually by the Secretary. Whenever in his opinion the
interests of the public health would be promoted by a
conference, the Secretary may invite as many of such health
authorities and officials of other State or local public or
private agencies, institutions, or organizations to confer as
he deems necessary or proper. Upon the application of health
authorities of five or more States it shall be the duty of the
Secretary to call a conference of all State health authorities
joining in the request. Each State represented at any
conference shall be entitled to a single vote. Whenever at any
such conference matters relating to mental health are to be
discussed, the mental health authorities of the respective
States shall be invited to attend.
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\1\ Former section 309 was repealed by section 6103(d)(1)(B) of
Public Law 101-239 (103 Stat. 2205).
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(b) From time to time the Secretary shall issue information
related to public health, in the form of publications or
otherwise, for the use of the public, and shall publish weekly
reports of health conditions in the United States and other
countries and other pertinent health information for the use of
persons and institutions concerned with health services.
SEC. 310A. [242S] CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF
WOMEN'S HEALTH.
(a) Establishment.--There is established within the Office
of the Director of the Centers for Disease Control and
Prevention, an office to be known as the Office of Women's
Health (referred to in this section as the ``Office''). The
Office shall be headed by a director who shall be appointed by
the Director of such Centers.
(b) Purpose.--The Director of the Office shall--
(1) report to the Director of the Centers for
Disease Control and Prevention on the current level of
the Centers' activity regarding women's health
conditions across, where appropriate, age, biological,
and sociocultural contexts, in all aspects of the
Centers' work, including prevention programs, public
and professional education, services, and treatment;
(2) establish short-range and long-range goals and
objectives within the Centers for women's health and,
as relevant and appropriate, coordinate with other
appropriate offices on activities within the Centers
that relate to prevention, research, education and
training, service delivery, and policy development, for
issues of particular concern to women;
(3) identify projects in women's health that should
be conducted or supported by the Centers;
(4) consult with health professionals,
nongovernmental organizations, consumer organizations,
women's health professionals, and other individuals and
groups, as appropriate, on the policy of the Centers
with regard to women; and
(5) serve as a member of the Department of Health
and Human Services Coordinating Committee on Women's
Health (established under section 229(b)(4)).
(c) Definition.--As used in this section, the term
``women's health conditions'', with respect to women of all
age, ethnic, and racial groups, means diseases, disorders, and
conditions--
(1) unique to, significantly more serious for, or
significantly more prevalent in women; and
(2) for which the factors of medical risk or type
of medical intervention are different for women, or for
which there is reasonable evidence that indicates that
such factors or types may be different for women.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2010 through 2014.
Part B--Federal-State Cooperation
in general
Sec. 311. [243] (a) The Secretary is authorized to accept
from State and local authorities any assistance in the
enforcement of quarantine regulations made pursuant to this Act
which such authorities may be able and willing to provide. The
Secretary shall also assist States and their political
subdivisions in the prevention and suppression of communicable
diseases and with respect to other public health matters, shall
cooperate with and aid State and local authorities in the
enforcement of their quarantine and other health regulations,
and shall advise the several States on matters relating to the
preservation and improvement of the public health.
(b) The Secretary shall encourage cooperative activities
between the States with respect to comprehensive and continuing
planning as to their current and future health needs, the
establishment and maintenance of adequate public health
services, and otherwise carrying out the public health
activities. The Secretary is also authorized to train personnel
for State and local health work. The Secretary may charge only
private entities reasonable fees for the training of their
personnel under the preceding sentence.
(c)(1) The Secretary is authorized to develop (and may take
such action as may be necessary to implement) a plan under
which personnel, equipment, medical supplies, and other
resources of the Service and other agencies under the
jurisdiction of the Secretary may be effectively used to
control epidemics of any disease or condition and to meet other
health emergencies or problems. The Secretary may enter into
agreements providing for the cooperative planning between the
Service and public and private community health programs and
agencies to cope with health problems (including epidemics and
health emergencies).
(2) The Secretary may, at the request of the appropriate
State or local authority, extend temporary (not in excess of
six months) assistance to States or localities in meeting
health emergencies of such a nature as to warrant Federal
assistance. The Secretary may require such reimbursement of the
United States for assistance provided under this paragraph as
he may determine to be reasonable under the circumstances. Any
reimbursement so paid shall be credited to the applicable
appropriation for the Service for the year in which such
reimbursement is received.
SEC. 312. [244] PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
(a) In General.--The Secretary shall award grants to
States, political subdivisions of States, Indian tribes, and
tribal organizations to develop and implement public access
defibrillation programs--
(1) by training and equipping local emergency
medical services personnel, including firefighters,
police officers, paramedics, emergency medical
technicians, and other first responders, to administer
immediate care, including cardiopulmonary resuscitation
and automated external defibrillation, to cardiac
arrest victims;
(2) by purchasing automated external
defibrillators, placing the defibrillators in public
places where cardiac arrests are likely to occur, and
training personnel in such places to administer
cardiopulmonary resuscitation and automated external
defibrillation to cardiac arrest victims;
(3) by setting procedures for proper maintenance
and testing of such devices, according to the
guidelines of the manufacturers of the devices;
(4) by providing training to members of the public
in cardiopulmonary resuscitation and automated external
defibrillation;
(5) by integrating the emergency medical services
system with the public access defibrillation programs
so that emergency medical services personnel, including
dispatchers, are informed about the location of
automated external defibrillators in their community;
and
(6) by encouraging private companies, including
small businesses, to purchase automated external
defibrillators and provide training for their employees
to administer cardiopulmonary resuscitation and
external automated defibrillation to cardiac arrest
victims in their community.
(b) Preference.--In awarding grants under subsection (a),
the Secretary shall give a preference to a State, political
subdivision of a State, Indian tribe, or tribal organization
that--
(1) has a particularly low local survival rate for
cardiac arrests, or a particularly low local response
rate for cardiac arrest victims; or
(2) demonstrates in its application the greatest
commitment to establishing and maintaining a public
access defibrillation program.
(c) Use of Funds.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under subsection (a) may use funds received through such
grant to--
(1) purchase automated external defibrillators that
have been approved, or cleared for marketing, by the
Food and Drug Administration;
(2) provide automated external defibrillation and
basic life support training in automated external
defibrillator usage through nationally recognized
courses;
(3) provide information to community members about
the public access defibrillation program to be funded
with the grant;
(4) provide information to the local emergency
medical services system regarding the placement of
automated external defibrillators in public places;
(5) produce materials to encourage private
companies, including small businesses, to purchase
automated external defibrillators;
(6) establish an information clearinghouse, that
shall be administered by an organization that has
substantial expertise in pediatric education, pediatric
medicine, and electrophysiology and sudden death, that
provides information to increase public access to
defibrillation in schools; and
(7) further develop strategies to improve access to
automated external defibrillators in public places.
(d) Application.--
(1) In general.--To be eligible to receive a grant
under subsection (a), a State, political subdivision of
a State, Indian tribe, or tribal organization shall
prepare and submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may reasonably require.
(2) Contents.--An application submitted under
paragraph (1) shall--
(A) describe the comprehensive public
access defibrillation program to be funded with
the grant and demonstrate how such program
would make automated external defibrillation
accessible and available to cardiac arrest
victims in the community;
(B) contain procedures for implementing
appropriate nationally recognized training
courses in performing cardiopulmonary
resuscitation and the use of automated external
defibrillators;
(C) contain procedures for ensuring direct
involvement of a licensed medical professional
and coordination with the local emergency
medical services system in the oversight of
training and notification of incidents of the
use of the automated external defibrillators;
(D) contain procedures for proper
maintenance and testing of the automated
external defibrillators, according to the
labeling of the manufacturer;
(E) contain procedures for ensuring
notification of local emergency medical
services system personnel, including
dispatchers, of the location and type of
devices used in the public access
defibrillation program; and
(F) provide for the collection of data
regarding the effectiveness of the public
access defibrillation program to be funded with
the grant in affecting the out-of-hospital
cardiac arrest survival rate.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $25,000,000 for for \1\ each of fiscal years 2003
through 2014. Not more than 10 percent of amounts received
under a grant awarded under this section may be used for
administrative expenses.
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\1\ The words ``for for'' so in law.
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SEC. 313. [245] PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
(a) In General.--The Secretary shall award grants to
political subdivisions of States, Indian tribes, and tribal
organizations to develop and implement innovative,
comprehensive, community-based public access defibrillation
demonstration projects that--
(1) provide cardiopulmonary resuscitation and
automated external defibrillation to cardiac arrest
victims in unique settings;
(2) provide training to community members in
cardiopulmonary resuscitation and automated external
defibrillation; and
(3) maximize community access to automated external
defibrillators.
(b) Use of Funds.--A recipient of a grant under subsection
(a) shall use the funds provided through the grant to--
(1) purchase automated external defibrillators that
have been approved, or cleared for marketing, by the
Food and Drug Administration;
(2) provide basic life training in automated
external defibrillator usage through nationally
recognized courses;
(3) provide information to community members about
the public access defibrillation demonstration project
to be funded with the grant;
(4) provide information to the local emergency
medical services system regarding the placement of
automated external defibrillators in the unique
settings; and
(5) further develop strategies to improve access to
automated external defibrillators in public places.
(c) Application.--
(1) In general.--To be eligible to receive a grant
under subsection (a), a political subdivision of a
State, Indian tribe, or tribal organization shall
prepare and submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may reasonably require.
(2) Contents.--An application submitted under
paragraph (1) may--
(A) describe the innovative, comprehensive,
community-based public access defibrillation
demonstration project to be funded with the
grant;
(B) explain how such public access
defibrillation demonstration project represents
innovation in providing public access to
automated external defibrillation; and
(C) provide for the collection of data
regarding the effectiveness of the
demonstration project to be funded with the
grant in--
(i) providing emergency
cardiopulmonary resuscitation and
automated external defibrillation to
cardiac arrest victims in the setting
served by the demonstration project;
and
(ii) affecting the cardiac arrest
survival rate in the setting served by
the demonstration project.
(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2002 through 2006. Not more than 10
percent of amounts received under a grant awarded under this
section may be used for administrative expenses.
grants for comprehensive health planning and public health services
Grants to States for Comprehensive State Health Planning
Sec. 314. [246] (a)(1) Authorization.--In order to assist
the States in comprehensive and continuing planning for their
current and future health needs, the Secretary is authorized
during the period beginning July 1, 1966, and ending June 30,
1973, to make grants to States which have submitted, and had
approved by the Secretary, State plans for comprehensive State
health planning. For the purposes of carrying out this
subsection, there are hereby authorized to be appropriated
$2,500,000 for the fiscal year ending June 30, 1967, $7,000,000
for the fiscal year ending June 30, 1968, $10,000,000 for the
fiscal year ending June 30, 1969, $15,000,000 for the fiscal
year ending June 30, 1970, $15,000,000 for the fiscal year
ending June 30, 1971, $17,000,000 for the fiscal year ending
June 30, 1972, $20,000,000 for the fiscal year ending June 30,
1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) State Plans for Comprehensive State Health Planning.--
In order to be approved for purposes of this subsection, a
State plan for comprehensive State health planning must--
(A) designate, or provide for the establishment of,
a single State agency, which may be an
interdepartmental agency, as the sole agency for
administering or supervising the administration of the
State's health planning functions under the plan;
(B) provide for the establishment of a State health
planning council, which shall include representatives
of Federal, State, and local agencies (including as an
ex officio member, if there is located in such State
one or more hospitals or other health care facilities
of the Department of Veterans Affairs, the individual
whom the Secretary of Veterans Affairs shall have
designated to serve on such council as the
representative of the hospitals or other health care
facilities of such Department which are located in such
State) and nongovernmental organizations and groups
concerned with health (including representation of the
regional medical program or programs included in whole
or in part within the State) and of consumers of health
services, to advise such State agency in carrying out
its functions under the plan, and a majority of the
membership of such council shall consist of
representatives of consumers of health services;
(C) set forth policies and procedures for the
expenditure of funds under the plan, which, in the
judgment of the Secretary, are designed to provide for
comprehensive State planning for health services (both
public and private and including home health care),
including the facilities and persons required for the
provision of such services, to meet the health needs of
the people of the State and including environmental
considerations as they relate to public health;
(D) provide for encouraging cooperative efforts
among governmental or nongovernmental agencies,
organizations and groups concerned with health
services, facilities, or manpower, and for cooperative
efforts between such agencies, organizations, and
groups and similar agencies, organizations, and groups
in the fields of education, welfare, and
rehabilitation;
(E) contain or be supported by assurances
satisfactory to the Secretary that the funds paid under
this subsection will be used to supplement and, to the
extent practicable, to increase the level of funds that
would otherwise be made available by the State for the
purpose of comprehensive health planning and not to
supplant such non-Federal funds;
(F) \1\ provide such methods of administration
(including methods relating to the establishment and
maintenance of personnel standards on a merit basis,
except that the Secretary shall exercise no authority
with respect to the selection, tenure of office, and
compensation of any individual employed in accordance
with such methods) as are found by the Secretary to be
necessary for the proper and efficient operation of the
plan;
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\1\ Section 208(a)(3) of Public Law 91-648 (42 U.S.C. 4728)
transferred to the United States Civil Service Commission all
functions, powers, and duties of the Secretary under any law applicable
to a grant program which requires the establishment and maintenance of
personnel standards on a merit basis with respect to the program.
Reorganization Plan No. 2 of 1978 (42 U.S.C. 1101 note) transferred to
the Office of Personnel Management all functions of the United States
Civil Service Commission.
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(G) provide that the State agency will make such
reports, in such form and containing such information,
as the Secretary may from time to time reasonably
require, and will keep such records and afford such
access thereto as the Secretary finds necessary to
assure the correctness and verification of such
reports;
(H) provide that the State agency will from time to
time, but not less often than annually, review its
State plan approved under this subsection and submit to
the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for
assisting each health care facility in the State to
develop a program for capital expenditures for
replacement, modernization, and expansion which is
consistent with an overall State plan developed in
accordance with criteria established by the Secretary
after consultation with the State which will meet the
needs of the State for health care facilities,
equipment, and services without duplication and
otherwise in the most efficient and economical manner,
and (ii) provide that the State agency furnishing such
assistance will periodically review the program
(developed pursuant to clause (i)) of each health care
facility in the State and recommended appropriate
modification thereof;
(J) provide for such fiscal control and fund
accounting procedures as may be necessary to assure
proper disbursement of and accounting for funds paid to
the State under this subsection; and
(K) contain such additional information and
assurances as the Secretary may find necessary to carry
out the purposes of this subsection.
(3)(A) State Allotments.--From the sums appropriated for
such purpose for each fiscal year, the several States shall be
entitled to allotments determined, in accordance with
regulations, on the basis of the population and the per capita
income of the respective States; except that no such allotment
to any State for any fiscal year shall be less than 1 per
centum of the sum appropriated for such fiscal year pursuant to
paragraph (1). Any such allotment to a State for a fiscal year
shall remain available for obligation by the State, in
accordance with the provisions of this subsection and the
State's plan approved thereunder, until the close of the
succeeding fiscal year.
(B) The amount of any allotment to a State under
subparagraph (A) for any fiscal year which the Secretary
determines will not be required by the State, during the period
for which it is available, for the purposes for which allotted
shall be available for reallotment by the Secretary from time
to time, on such date or dates as he may fix, to other States
with respect to which such a determination has not been made,
in proportion to the original allotments to such States under
subparagraph (A) for such fiscal year, but with such
proportionate amount for any of such other States being reduced
to the extent it exceeds the sum the Secretary estimates such
State needs and will be able to use during such period; and the
total of such reductions shall be similarly reallotted among
the States whose proportionate amounts were not so reduced. Any
amount so reallotted to a State from funds appropriated
pursuant to this subsection for a fiscal year shall be deemed
part of its allotment under subparagraph (A) for such fiscal
year.
(4) Payments to States.--From each State's allotment for a
fiscal year under this subsection, the State shall from time to
time be paid the Federal share of the expenditures incurred
during that year or the succeeding year pursuant to its State
plan approved under this subsection. Such payments shall be
made on the basis of estimates by the Secretary of the sums the
State will need in order to perform the planning under its
approved State plan under this subsection, but with such
adjustments as may be necessary to take account of previously
made underpayments or overpayments. The ``Federal share'' for
any State for purposes of this subsection shall be all, or such
part as the Secretary may determine, of the cost of such
planning, except that in the case of the allotments for the
fiscal year ending June 30, 1970, it shall not exceed 75 per
centum, of such cost.
Project Grants for Areawide Health Planning
(b)(1)(A) The Secretary is authorized, during the period
beginning July 1, 1966, and ending June 30, 1974, to make, with
the approval of the State agency administering or supervising
the administration of the State plan approved under subsection
(a), project grants to any other public or nonprofit private
agency or organization (but with appropriate representation of
the interests of local government where the recipient of the
grant is not a local government or combination thereof or an
agency of such government or combination) to cover not to
exceed 75 per centum of the costs of projects for developing
(and from time to time revising) comprehensive regional,
metropolitan area, or other local area plans for coordination
of existing and planned health services, including the
facilities and persons required for provision of such services;
and including the provision of such services through home
health care; except that in the case of project grants made in
any State prior to July 1, 1968, approval of such State agency
shall be required only if such State has such a State plan in
effect at the time of such grants. No grant may be made under
this subsection after June 30, 1970, to any agency or
organization to develop or revise health plans for an area
unless the Secretary determines that such agency or
organization provides means for appropriate representation of
the interests of the hospitals, other health care facilities,
and practicing physicians serving such area, and the general
public. For the purposes of carrying out this subsection, there
are hereby authorized to be appropriated $5,000,000 for the
fiscal year ending June 30, 1967, $7,500,000 for the fiscal
year ending June 30, 1968, $10,000,000 for the fiscal year
ending June 30, 1969, $15,000,000 for the fiscal year ending
June 30, 1970, $20,000,000 for the fiscal year ending June 30,
1971, $30,000,000 for the fiscal year ending June 30, 1972,
$40,000,000 for the fiscal year ending June 30, 1973, and
$25,100,000 for the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under
subparagraph (A) to the State agency administering or
supervising the administration of the State plan approved under
subsection (a) with respect to a particular region or area, but
only if (i) no application for such a grant with respect to
such region or area has been filed by any other agency or
organization qualified to receive such a grant, and (ii) such
State agency certifies, and the Secretary finds, that ample
opportunity has been afforded to qualified agencies and
organizations to file application for such a grant with respect
to such region or area and that it is improbable that, in the
foresee-able future, any agency or organization which is
qualified for such a grant will file application therefor.
(2)(A) In order to be approved under this subsection, an
application for a grant under this subsection must contain or
be supported by reasonable assurances that there has been or
will be established, in or for the area with respect to which
such grant is sought, an areawide health planning council. The
membership of such council shall include representatives of
public, voluntary, and non-profit private agencies,
institutions, and organizations concerned with health
(including representatives of the interests of local government
of the regional medical program for such area, and of consumers
of health services). A majority of the members of such council
shall consist of representatives of consumers of health
services.
(B) In addition, an application for a grant under this
subsection must contain or be supported by reasonable
assurances that the areawide health planning agency has made
provision for assisting health care facilities in its area to
develop a program for capital expenditures for replacement,
modernization, and expansion, which is consistent with an
overall State plan which will meet the needs of the State and
the area for health care facilities, equipment, and services
without duplication and otherwise in the most efficient and
economical manner.
Project Grants for Training, Studies, and Demonstrations
(c) The Secretary is also authorized, during the period
beginning July 1, 1966, and ending June 30, 1974, to make
grants to any public or nonprofit private agency, institution,
or other organization to cover all or any part of the cost of
projects for training, studies, or demonstrations looking
toward the development of improved or more effective
comprehensive health planning throughout the Nation. For the
purposes of carrying out this subsection, there are hereby
authorized to be appropriated $1,500,000 for the fiscal year
ending June 30, 1967, $2,500,000 for the fiscal year ending
June 30, 1968, $5,000,000 for the fiscal year ending June 30,
1969, $7,500,000 for the fiscal year ending June 30, 1970,
$8,000,000 for the fiscal year ending June 30, 1971,
$10,000,000 for the fiscal year ending June 30, 1972,
$12,000,000 for the fiscal year ending June 30, 1973, and
$4,700,000 for the fiscal year ending June 30, 1974.
family support groups for alzheimer's disease patients
Sec. 316. \1\ [247a] (a) Subject to available
appropriations, the Secretary, acting through the National
Institute of Mental Health, the National Institutes of Health,
and the Administration on Aging, shall promote the
establishment of family support groups to provide, without
charge, educational, emotional, and practical support to assist
individuals with Alzheimer's disease or a related memory
disorder and members of the families of such individuals. In
promoting the establishment of such groups, the Secretary shall
give priority to--
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\1\ With respect to section 315, subsection (d) of such section
provided as follows: ``This section shall cease to exist on March 31,
1989.''. See section 1 of Public Law 100-471 (102 Stat. 2284).
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(1) university medical centers and other
appropriate health care facilities which receive
Federal funds from the Secretary and which conduct
research on Alzheimer's disease or provide services to
individuals with such disease; and
(2) community-based programs which receive funds
from the Secretary, acting through the Administration
on Aging.
(b) The Secretary shall promote the establishment of a
national network to coordinate the family support groups
described in subsection (a).
project grants for preventive health services
Sec. 317. [247b] (a) The Secretary may make grants to
States, and in consultation with State health authorities, to
political subdivisions of States and to other public entities
to assist them in meeting the costs of establishing and
maintaining preventive health service programs.
(b) No grant may be made under subsection (a) unless an
application therefor has been submitted to, and approved by,
the Secretary. Such an application shall be in such form and be
submitted in such manner as the Secretary shall by regulation
prescribe and shall provide--
(1) a complete description of the type and extent
of the program for which the applicant is seeking a
grant under subsection (a);
(2) with respect to each such program (A) the
amount of Federal, State, and other funds obligated by
the applicant in its latest annual accounting period
for the provision of such program, (B) a description of
the services provided by the applicant in such program
in such period, (C) the amount of Federal funds needed
by the applicant to continue providing such services in
such program, and (D) if the applicant proposes changes
in the provision of the services in such program, the
priorities of such proposed changes, reasons for such
changes, and the amount of Federal funds needed by the
applicant to make such changes;
(3) assurances satisfactory to the Secretary that
the program which will be provided with funds under a
grant under subsection (a) will be provided in a manner
consistent with the State health plan in effect under
section 1524(c) and in those cases where the applicant
is a State, that such program will be provided, where
appropriate, in a manner consistent with any plans in
effect under an application approved under section 315;
(4) assurances satisfactory to the Secretary that
the applicant will provide for such fiscal control and
fund accounting procedures as the Secretary by
regulation prescribes to assure the proper disbursement
of and accounting for funds received under grants under
subsection (a);
(5) assurances satisfactory to the Secretary that
the applicant will provide for periodic evaluation of
its program or programs;
(6) assurances satisfactory to the Secretary that
the applicant will make such reports (in such form and
containing such information as the Secretary may by
regulation prescribe) as the Secretary may reasonably
require and keep such records and afford such access
thereto as the Secretary may find necessary to assure
the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that
the applicant will comply with any other conditions
imposed by this section with respect to grants; and
(8) such other information as the Secretary may by
regulation prescribe.
(c)(1) The Secretary shall not approve an application
submitted under subsection (b) for a grant for a program for
which a grant was previously made under subsection (a) unless
the Secretary determines--
(A) the program for which the application was
submitted is operating effectively to achieve its
stated purpose,
(B) the applicant complied with the assurances
provided the Secretary when applying for such previous
grant, and
(C) the applicant will comply with the assurances
provided with the application.
(2) The Secretary shall review annually the activities
undertaken by each recipient of a grant under subsection (a) to
determine if the program assisted by such grant is operating
effectively to achieve its stated purposes and if the recipient
is in compliance with the assurances provided the Secretary
when applying for such grant.
(d) The amount of a grant under subsection (a) shall be
determined by the Secretary. Payments under such grants may be
made in advance on the basis of estimates or by the way of
reimbursement, with necessary adjustments on account of
underpayments or overpayments, and in such installments and on
such terms and conditions as the Secretary finds necessary to
carry out the purposes of such grants.
(e) The Secretary, at the request of a recipient of a grant
under subsection (a), may reduce the amount of such grant by--
(1) the fair market value of any supplies
(including vaccines and other preventive agents) or
equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel
expenses of any officer or employee of the Government
when detailed to the grant recipient and the amount of
any other costs incurred in connection with the detail
of such officer or employee.
When the furnishing of such supplies or equipment or the detail
of such an officer or employee is for the convenience of and at
the request of such grant recipient and for the purpose of
carrying out a program with respect to which the grant under
subsection (a) is made. The amount by which any such grant is
so reduced shall be available for payment by the Secretary of
the costs incurred in furnishing the supplies or equipment, or
in detailing the personnel, on which the reduction of such
grant is based, and such amount shall be deemed as part of the
grant and shall be deemed to have been paid to the grant
recipient.
(f)(1) Each recipient of a grant under subsection (a) shall
keep such records as the Secretary shall by regulation
prescribe, including records which fully disclose the amount
and disposition by such recipient of the proceeds of such
grant, the total cost of the undertaking in connection with
which such grant was made, and the amount of that portion of
the cost of the undertaking supplied by other sources, and such
other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall
have access for the purpose of audit and examination to any
books, documents, papers, and records of the recipient of
grants under subsection (a) that are pertinent to such grants.
(g)(1) Nothing in this section shall limit or otherwise
restrict the use of funds which are granted to a State or to an
agency or a political subdivision of a State under provisions
of Federal law (other than this section) and which are
available for the conduct of preventive health service programs
from being used on connection with programs assisted through
grants under subsection (a).
(2) Nothing in this section shall be construed to require
any State or any agency or political subdivision of a State to
have a preventive health service program which would require
any person, who objects to any treatment provided under such a
program, to be treated or to have any child or ward treated
under such program.
(h) The Secretary shall include, as part of the report
required by section 1705, a report on the extent of the
problems presented by the diseases and conditions referred to
in subsection (j) on the amount of funds obligated under grants
under subsection (a) in the preceding fiscal year for each of
the programs listed in subsection (j); and on the effectiveness
of the activities assisted under grants under subsection (a) in
controlling such diseases and conditions.
(i) The Secretary may provide technical assistance to
States, State health authorities, and other public entities in
connection with the operation of their preventive health
service programs.
(j)(1) Except for grants for immunization programs the
authorization of appropriations for which are established in
paragraph (2), for grants under subsections (a) and (k)(1) for
preventive health service programs to immunize without charge
children, adolescents, and adults against vaccine-preventable
diseases, there are authorized to be appropriated such sums as
may be necessary. Not more than 10 percent ot the total amount
appropriated under the preceding sentence for any fiscal year
shall be available for grants under subsection (k)(1) for such
fiscal year.
(2) For grants under subsection (a) for preventive health
service programs for the provision without charge of
immunizations with vaccines approved for use, and recommended
for routine use, there are authorized to be appropriated such
sums as may be necessary.
(k)(1) The Secretary may make grants to States, political
subdivisions of States, and other public and nonprofit private
entities for--
(A) research into the prevention and control of
diseases that may be prevented through vaccination;
(B) demonstration projects for the prevention and
control of such diseases;
(C) public information and education programs for
the prevention and control of such diseases; and
(D) education, training, and clinical skills
improvement activities in the prevention and control of
such diseases for health professionals (including
allied health personnel).
(2) The Secretary may make grants to States, political
subdivisions of States, and other public and nonprofit private
entities for--
(A) research into the prevention and control of
diseases and conditions;
(B) demonstration projects for the prevention and
control of such diseases and conditions;
(C) public information and education programs for
the prevention and control of such diseases and
conditions; and
(D) education, training, and clinical skills
improvement activities in the prevention and control of
such diseases and conditions for health professionals
(including allied health personnel).
(3) No grant may be made under this subsection unless an
application therefor is submitted to the Secretary in such
form, at such time, and containing such information as the
Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) shall apply to grants
under this subsection in the same manner as such subsections
apply to grants under subsection (a).
(l) Authority to Purchase Recommended Vaccines for
Adults.--
(1) In general.--The Secretary may negotiate and
enter into contracts with manufacturers of vaccines for
the purchase and delivery of vaccines for adults as
provided for under subsection (e).
(2) State purchase.--A State may obtain additional
quantities of such adult vaccines (subject to amounts
specified to the Secretary by the State in advance of
negotiations) through the purchase of vaccines from
manufacturers at the applicable price negotiated by the
Secretary under this subsection.
(m) Demonstration Program To Improve Immunization
Coverage.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall establish a demonstration program to
award grants to States to improve the provision of
recommended immunizations for children, adolescents,
and adults through the use of evidence-based,
population-based interventions for high-risk
populations.
(2) State plan.--To be eligible for a grant under
paragraph (1), a State shall submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require, including a State plan that describes the
interventions to be implemented under the grant and how
such interventions match with local needs and
capabilities, as determined through consultation with
local authorities.
(3) Use of funds.--Funds received under a grant
under this subsection shall be used to implement
interventions that are recommended by the Task Force on
Community Preventive Services (as established by the
Secretary, acting through the Director of the Centers
for Disease Control and Prevention) or other evidence-
based interventions, including--
(A) providing immunization reminders or
recalls for target populations of clients,
patients, and consumers;
(B) educating targeted populations and
health care providers concerning immunizations
in combination with one or more other
interventions;
(C) reducing out-of-pocket costs for
families for vaccines and their administration;
(D) carrying out immunization-promoting
strategies for participants or clients of
public programs, including assessments of
immunization status, referrals to health care
providers, education, provision of on-site
immunizations, or incentives for immunization;
(E) providing for home visits that promote
immunization through education, assessments of
need, referrals, provision of immunizations, or
other services;
(F) providing reminders or recalls for
immunization providers;
(G) conducting assessments of, and
providing feedback to, immunization providers;
(H) any combination of one or more
interventions described in this paragraph; or
(I) immunization information systems to
allow all States to have electronic databases
for immunization records.
(4) Consideration.--In awarding grants under this
subsection, the Secretary shall consider any reviews or
recommendations of the Task Force on Community
Preventive Services.
(5) Evaluation.--Not later than 3 years after the
date on which a State receives a grant under this
subsection, the State shall submit to the Secretary an
evaluation of progress made toward improving
immunization coverage rates among high-risk populations
within the State.
(6) Report to congress.--Not later than 4 years
after the date of enactment of the Affordable Health
Choices Act, the Secretary shall submit to Congress a
report concerning the effectiveness of the
demonstration program established under this subsection
together with recommendations on whether to continue
and expand such program.
(7) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection, such sums as may be necessary for each of
fiscal years 2010 through 2014.
screenings, referrals, and education regarding lead poisoning
Sec. 317A. [247b-1] (a) Authority for Grants.--
(1) In general.--Subject to paragraph (2), the
Secretary, acting through the Director of the Centers
for Disease Control and Prevention, may make grants to
States and political subdivisions of States for the
initiation and expansion of community programs
designed--
(A) to provide, for infants and children--
(i) screening for elevated blood
lead levels;
(ii) referral for treatment of such
levels; and
(iii) referral for environmental
intervention associated with such
levels; and
(B) to provide education about childhood
lead poisoning.
(2) Authority regarding certain entities.--With
respect to a geographic area with a need for activities
authorized in paragraph (1), in any case in which
neither the State nor the political subdivision in
which such area is located has applied for a grant
under paragraph (1), the Secretary may make a grant
under such paragraph to any grantee under section 329,
330, or 340A for carrying out such activities in the
area.
(3) Provision of all services and activities
through each grantee.--In making grants under paragraph
(1), the Secretary shall ensure that each of the
activities described in such paragraph is provided
through each grantee under such paragraph. The
Secretary may authorize such a grantee to provide the
services and activities directly, or through
arrangements with other providers.
(b) Status as Medicaid Provider.--
(1) In general.--Subject to paragraph (2), the
Secretary may not make a grant under subsection (a)
unless, in the case of any service described in such
subsection that is made available pursuant to the State
plan approved under title XIX of the Social Security
Act for the State involved--
(A) the applicant for the grant will
provide the service directly, and the applicant
has entered into a participation agreement
under the State plan and is qualified to
receive payments under such plan; or
(B) the applicant will enter into an
agreement with a provider under which the
provider will provide the service, and the
provider has entered into such a participation
agreement and is qualified to receive such
payments.
(2) Waiver regarding certain secondary
agreements.--
(A) In the case of a provider making an
agreement pursuant to paragraph (1)(B)
regarding the provision of services, the
requirement established in such paragraph
regarding a participation agreement shall be
waived by the Secretary if the provider does
not, in providing health care services, impose
a charge or accept reimbursement available from
any third-party payor, including reimbursement
under any insurance policy or under any Federal
or State health benefits plan.
(B) A determination by the Secretary of
whether a provider referred to in subparagraph
(A) meets the criteria for a waiver under such
subparagraph shall be made without regard to
whether the provider accepts voluntary
donations regarding the provision of services
to the public.
(c) Priority in Making Grants.--In making grants under
subsection (a), the Secretary shall give priority to
applications for programs that will serve areas with a high
incidence of elevated blood lead levels in infants and
children.
(d) Grant Application.--No grant may be made under
subsection (a), unless an application therefor has been
submitted to, and approved by, the Secretary. Such an
application shall be in such form and shall be submitted in
such manner as the Secretary shall prescribe and shall include
each of the following:
(1) A complete description of the program which is
to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that
the program to be provided under the grant applied for
will include educational programs designed to--
(A) communicate to parents, educators, and
local health officials the significance and
prevalence of lead poisoning in infants and
children (including the sources of lead
exposure, the importance of screening young
children for lead, and the preventive steps
that parents can take in reducing the risk of
lead poisoning) which the program is designed
to detect and prevent; and
(B) communicate to health professionals and
paraprofessionals updated knowledge concerning
lead poisoning and research (including the
health consequences, if any, of low-level lead
burden; the prevalence of lead poisoning among
all socioeconomic groupings; the benefits of
expanded lead screening; and the therapeutic
and other interventions available to prevent
and combat lead poisoning in affected children
and families).
(3) Assurances satisfactory to the Secretary that
the applicant will report on a quarterly basis the
number of infants and children screened for elevated
blood lead levels, the number of infants and children
who were found to have elevated blood lead levels, the
number and type of medical referrals made for such
infants and children, the outcome of such referrals,
and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that
the applicant will make such reports respecting the
program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary that
the applicant will coordinate the activities carried
out pursuant to subsection (a) with related activities
and services carried out in the State by grantees under
title V or XIX of the Social Security Act.
(6) Assurances satisfactory to the Secretary that
Federal funds made available under such a grant for any
period will be so used as to supplement and, to the
extent practical, increase the level of State, local,
and other non-Federal funds that would, in the absence
of such Federal funds, be made available for the
program for which the grant is to be made and will in
no event supplant such State, local, and other non-
Federal funds.
(7) Assurances satisfactory to the Secretary that
the applicant will ensure complete and consistent
reporting of all blood lead test results from
laboratories and health care providers to State and
local health departments in accordance with guidelines
of the Centers for Disease Control and Prevention for
standardized reporting as described in subsection (m).
(8) Such other information as the Secretary may
prescribe.
(e) Relationship to Services and Activities Under Other
Programs.--
(1) In general.--A recipient of a grant under
subsection (a) may not make payments from the grant for
any service or activity to the extent that payment has
been made, or can reasonably be expected to be made,
with respect to such service or activity--
(A) under any State compensation program,
under an insurance policy, or under any Federal
or State health benefits program; or
(B) by an entity that provides health
services on a prepaid basis.
(2) Applicability to certain secondary agreements
for provision of services.--Paragraph (1) shall not
apply in the case of a provider through which a grantee
under subsection (a) provides services under such
subsection if the Secretary has provided a waiver under
subsection (b)(2) regarding the provider.
(f) Method and Amount of Payment.--The Secretary shall
determine the amount of a grant made under subsection (a).
Payments under such grants may be made in advance on the basis
of estimates or by way of reimbursement, with necessary
adjustments on account of underpayments or overpayments, and in
such installments and on such terms and conditions as the
Secretary finds necessary to carry out the purposes of such
grants. Not more than 10 percent of any grant may be obligated
for administrative costs.
(g) Supplies, Equipment, and Employee Detail.--The
Secretary, at the request of a recipient of a grant under
subsection (a), may reduce the amount of such grant by--
(1) the fair market value of any supplies or
equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel
expenses of any officer or employee of the Government
when detailed to the grant recipient and the amount of
any other costs incurred in connection with the detail
of such officer or employee;
when the furnishing of such supplies or equipment or the detail
of such an officer or employee is for the convenience of and at
the request of such grant recipient and for the purpose of
carrying out a program with respect to which the grant under
subsection (a) is made. The amount by which any such grant is
so reduced shall be available for payment by the Secretary of
the costs incurred in furnishing the supplies or equipment, or
in detailing the personnel, on which the reduction of such
grant is based, and such amount shall be deemed as part of the
grant and shall be deemed to have been paid to the grant
recipient.
(h) Records.--Each recipient of a grant under subsection
(a) shall keep such records as the Secretary shall prescribe,
including records which fully disclose the amount and
disposition by such recipient of the proceeds of such grant,
the total cost of the undertaking in connection with which such
grant was made, and the amount of that portion of the cost of
the undertaking supplied by other sources, and such other
records as will facilitate an effective audit.
(i) Audit and Examination of Records.--The Secretary and
the Comptroller General of the United States, or any of their
duly authorized representatives, shall have access for the
purpose of audit and examination to any books, documents,
papers, and records of the recipient of a grant under
subsection (a), that are pertinent to such grant.
(j) Annual Report.--
(1) In general.--Not later than May 1 of each year,
the Secretary shall submit to the Congress a report on
the effectiveness during the preceding fiscal year of
programs carried out with grants under subsection (a)
and of any programs that are carried out by the
Secretary pursuant to subsection (l)(2).
(2) Certain requirements.--Each report under
paragraph (1) shall include, in addition to any other
information that the Secretary may require, the
following information:
(A) The number of infants and children
screened.
(B) Demographic information on the
population of infants and children screened,
including the age and racial or ethnic status
of such population.
(C) The number of screening sites.
(D) A description of the severity of the
extent of the blood lead levels of the infants
and children screened, expressed in categories
of severity.
(E) The sources of payment for the
screenings.
(F) The number of grantees that have
established systems to ensure mandatory
reporting of all blood lead tests from
laboratories and health care providers to State
and local health departments.
(G) A comparison of the data provided
pursuant to subparagraphs (A) through (F) with
the equivalent data, if any, provided in the
report under paragraph (1) preceding the report
involved.
(k) Indian Tribes.--For purposes of this section, the term
``political subdivision'' includes Indian tribes.
(l) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out this section, there are
authorized to be appropriated $40,000,000 for fiscal
year 1993, and such sums as may be necessary for each
of the fiscal years 1994 through 2005.
(2) Allocation for other programs.--Of the amounts
appropriated under paragraph (1) for any fiscal year,
the Secretary may reserve not more than 20 percent for
carrying out programs regarding the activities
described in subsection (a) in addition to the program
of grants established in such subsection.
(m) Guidelines for Standardized Reporting.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, shall develop national guidelines for the
uniform reporting of all blood lead test results to State and
local health departments.
education, technology assessment, and epidemiology regarding lead
poisoning
Sec. 317B. [247b-3] (a) Prevention.--
(1) Public education.--The Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall carry out a program to educate
health professionals and paraprofessionals and the
general public on the prevention of lead poisoning in
infants and children. In carrying out the program, the
Secretary shall make available information concerning
the health effects of low-level lead toxicity, the
causes of lead poisoning, and the primary and secondary
preventive measures that may be taken to prevent such
poisoning.
(2) Interagency task force.--
(A) Not later than 6 months after the date
of the enactment of the Preventive Health
Amendments of 1992 \1\, the Secretary shall
establish a council to be known as the
Interagency Task Force on the Prevention of
Lead Poisoning (in this paragraph referred to
as the ``Task Force''). The Task Force shall
coordinate the efforts of Federal agencies to
prevent lead poisoning.
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\1\ Enacted October 27, 1992.
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(B) The Task Force shall be composed of--
(i) the Secretary, who shall serve
as the chair of the Task Force;
(ii) the Secretary of Housing and
Urban Development;
(iii) the Administrator of the
Environmental Protection Agency; and
(iv) senior staff of each of the
officials specified in clauses (i)
through (iii), as selected by the
officials respectively.
(C) The Task Force shall--
(i) review, evaluate, and
coordinate current strategies and plans
formulated by the officials serving as
members of the Task Force, including--
(I) the plan of the
Secretary of Health and Human
Services entitled ``Strategic
Plan for the Elimination of
Lead Poisoning'', dated
February 21, 1991;
(II) the plan of the
Secretary of Housing and Urban
Development entitled
``Comprehensive and Workable
Plan for the Abatement of Lead-
Based Paint in Privately Owned
Housing'', dated December 7,
1990; and
(III) the strategy of the
Administrator of the
Environmental Protection Agency
entitled ``Strategy for
Reducing Lead Exposures'',
dated February 21, 1991;
(ii) develop a unified
implementation plan for programs that
receive Federal financial assistance
for activities related to the
prevention of lead poisoning;
(iii) establish a mechanism for
sharing and disseminating information
among the agencies represented on the
Task Force;
(iv) identify the most promising
areas of research and education
concerning lead poisoning;
(v) identify the practical and
technological constraints to expanding
lead poisoning prevention;
(vi) annually carry out a
comprehensive review of Federal
programs providing assistance to
prevent lead poisoning, and not later
than May 1 of each year, submit to the
Committee on Labor and Human Resources
of the Senate and the Committee on the
Environment and Public Works of the
Senate, and to the Committee on Energy
and Commerce of the House of
Representatives, a report that
summarizes the findings made as a
result of such review and that contains
the recommendations of the Task Force
on the programs and policies with
respect to which the Task Force is
established, including related
budgetary recommendations; and
(vii) annually review and
coordinate departmental and agency
budgetary requests with respect to all
lead poisoning prevention activities of
the Federal Government.
(b) Technology Assessment and Epidemiology.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, shall, directly or through grants or
contracts--
(1) provide for the development of improved, more
cost-effective testing measures for detecting lead
toxicity in children;
(2) provide for the development of improved methods
of assessing the prevalence of lead poisoning,
including such methods as may be necessary to conduct
individual assessments for each State;
(3) provide for the collection of data on the
incidence and prevalence of lead poisoning of infants
and children, on the demographic characteristics of
infants and children with such poisoning (including
racial and ethnic status), and on the source of payment
for treatment for such poisoning (including the extent
to which insurance has paid for such treatment); and
(4) provide for any applied research necessary to
improve the effectiveness of programs for the
prevention of lead poisoning in infants and children.
national center on birth defects and developmental disabilities
Sec. 317C. [247b-4] (a) In General.--
(1) National center.--There is established within
the Centers for Disease Control and Prevention a center
to be known as the National Center on Birth Defects and
Developmental Disabilities (referred to in this section
as the ``Center''), which shall be headed by a director
appointed by the Director of the Centers for Disease
Control and Prevention.
(2) General duties.--The Secretary shall carry out
programs--
(A) to collect, analyze, and make available
data on birth defects, developmental
disabilities, and disabilities and health (in a
manner that facilitates compliance with
subsection (c)(2)), including data on the
causes of such defects and disabilities and on
the incidence and prevalence of such defects
and disabilities;
(B) to operate regional centers for the
conduct of applied epidemiological research on
the prevention of such defects and
disabilities;
(C) to provide information and education to
the public on the prevention of such defects
and disabilities;
(D) to conduct research on and to promote
the prevention of such defects and
disabilities, and secondary health conditions
among individuals with disabilities; and
(E) to support a National Spina Bifida
Program to prevent and reduce suffering from
the Nation's most common permanently disabling
birth defect.
(3) Folic acid.--The Secretary shall carry out
section 317J through the Center.
(4) Certain programs.--
(A) Transfers.--All programs and functions
described in subparagraph (B) are transferred
to the Center, effective upon the expiration of
the 180-day period beginning on the date of the
enactment of the Children's Health Act of 2000
\1\.
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\1\ Public Law 106-310, enacted October 17, 2000.
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(B) Relevant programs.--The programs and
functions described in this subparagraph are
all programs and functions that--
(i) relate to birth defects; folic
acid; cerebral palsy; mental
retardation; child development; newborn
screening; autism; fragile X syndrome;
fetal alcohol syndrome; pediatric
genetic disorders; disability
prevention; or other relevant diseases,
disorders, or conditions as determined
the Secretary; and
(ii) were carried out through the
National Center for Environmental
Health as of the day before the date of
the enactment of the Act referred to in
subparagraph (A).
(C) Related transfers.--Personnel employed
in connection with the programs and functions
specified in subparagraph (B), and amounts
available for carrying out the programs and
functions, are transferred to the Center,
effective upon the expiration of the 180-day
period beginning on the date of the enactment
of the Act referred to in subparagraph (A).
Such transfer of amounts does not affect the
period of availability of the amounts, or the
availability of the amounts with respect to the
purposes for which the amounts may be expended.
(b) Grants and Contracts.--
(1) In general.--In carrying out subsection (a),
the Secretary may make grants to and enter into
contracts with public and nonprofit private entities.
(2) Supplies and services in lieu of award funds.--
(A) Upon the request of a recipient of an
award of a grant or contract under paragraph
(1), the Secretary may, subject to subparagraph
(B), provide supplies, equipment, and services
for the purpose of aiding the recipient in
carrying out the purposes for which the award
is made and, for such purposes, may detail to
the recipient any officer or employee of the
Department of Health and Human Services.
(B) With respect to a request described in
subparagraph (A), the Secretary shall reduce
the amount of payments under the award involved
by an amount equal to the costs of detailing
personnel and the fair market value of any
supplies, equipment, or services provided by
the Secretary. The Secretary shall, for the
payment of expenses incurred in complying with
such request, expend the amounts withheld.
(3) Application for award.--The Secretary may make
an award of a grant or contract under paragraph (1)
only if an application for the award is submitted to
the Secretary and the application is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out the purposes for which the
award is to be made.
(c) Biennial Report.--Not later than February 1 of fiscal
year 1999 and of every second such year thereafter, the
Secretary shall submit to the Committee on Commerce of the
House of Representatives, and the Committee on Labor and Human
Resources of the Senate, a report that, with respect to the
preceding 2 fiscal years--
(1) contains information regarding the incidence
and prevalence of birth defects, developmental
disabilities, and the health status of individuals with
disabilities and the extent to which these conditions
have contributed to the incidence and prevalence of
infant mortality and affected quality of life;
(2) contains information under paragraph (1) that
is specific to various racial and ethnic groups
(including Hispanics, non-Hispanic whites, Blacks,
Native Americans, and Asian Americans);
(3) contains an assessment of the extent to which
various approaches of preventing birth defects,
developmental disabilities, and secondary health
conditions among individuals with disabilities have
been effective;
(4) describes the activities carried out under this
section;
(5) contains information on the incidence and
prevalence of individuals living with birth defects and
disabilities or developmental disabilities, information
on the health status of individuals with disabilities,
information on any health disparities experienced by
such individuals, and recommendations for improving the
health and wellness and quality of life of such
individuals;
(6) contains a summary of recommendations from all
birth defects research conferences sponsored by the
Centers for Disease Control and Prevention, including
conferences related to spina bifida; and
(7) contains any recommendations of the Secretary
regarding this section.
(d) Applicability of Privacy Laws.--The provisions of this
section shall be subject to the requirements of section 552a of
title 5, United States Code. All Federal laws relating to the
privacy of information shall apply to the data and information
that is collected under this section.
(e) Advisory Committee.--Notwithstanding any other
provision of law, the members of the advisory committee
appointed by the Director of the National Center for
Environmental Health that have expertise in birth defects,
developmental disabilities, and disabilities and health shall
be transferred to and shall advise the National Center on Birth
Defects and Developmental Disabilities effective on the date of
enactment of the Birth Defects and Developmental Disabilities
Prevention Act of 2003.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2003 through 2007.
preventive health measures with respect to prostate cancer
Sec. 317D. [247b-5] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may make grants to States and local health
departments for the purpose of enabling such States and
departments to carry out programs that may include the
following:
(1) To identify factors that influence the
attitudes or levels of awareness of men and health care
practitioners regarding screening for prostate cancer.
(2) To evaluate, in consultation with the Agency
for Health Care Policy and Research and the National
Institutes of Health, the effectiveness of screening
strategies for prostate cancer.
(3) To identify, in consultation with the Agency
for Health Care Policy and Research, issues related to
the quality of life for men after prostrate cancer
screening and followup.
(4) To develop and disseminate public information
and education programs for prostate cancer, including
appropriate messages about the risks and benefits of
prostate cancer screening for the general public,
health care providers, policy makers and other
appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and
minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary, who
shall take into consideration recommendations by the
United States Preventive Services Task Force and shall
seek input, where appropriate, from professional
societies and other private and public entities, that
there is sufficient consensus on the effectiveness of
prostate cancer screening--
(A) to screen men for prostate cancer as a
preventive health measure;
(B) to provide appropriate referrals for
the medical treatment of men who have been
screened under subparagraph (A) and to ensure,
to the extent practicable, the provision of
appropriate followup services and support
services such as case management;
(C) to establish mechanisms through which
State and local health departments can monitor
the quality of screening procedures for
prostate cancer, including the interpretation
of such procedures; and
(D) to improve, in consultation with the
Health Resources and Services Administration,
the education, training, and skills of health
practitioners (including appropriate allied
health professionals) in the detection and
control of prostate cancer.
(8) To evaluate activities conducted under
paragraphs (1) through (7) through appropriate
surveillance or program monitoring activities.
(b) Requirement of Matching Funds.--
(1) In general.--The Secretary may not make a grant
under subsection (a) unless the applicant involved
agrees, with respect to the costs to be incurred by the
applicant in carrying out the purpose described in such
section, to make available non-Federal contributions
(in cash or in kind under paragraph (2)) toward such
costs in an amount equal to not less than $1 for each
$3 of Federal funds provided in the grant. Such
contributions may be made directly or through donations
from public or private entities.
(2) Determination of amount of non-federal
contribution.--
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including equipment or services (and
excluding indirect or overhead costs). Amounts
provided by the Federal Government, or services
assisted or subsidized to any significant
extent by the Federal Government, may not be
included in determining the amount of such non-
Federal contributions.
(B) In making a determination of the amount
of non-Federal contributions for purposes of
paragraph (1), the Secretary may include only
non-Federal contributions in excess of the
average amount of non-Federal contributions
made by the applicant involved toward the
purpose described in subsection (a) for the 2-
year period preceding the fiscal year for which
the applicant involved is applying to receive a
grant under such subsection.
(C) In making a determination of the amount
of non-Federal contributions for purposes of
paragraph (1), the Secretary shall, subject to
subparagraphs (A) and (B) of this paragraph,
include any non-Federal amounts expended
pursuant to title XIX of the Social Security
Act by the applicant involved toward the
purpose described in paragraphs (1) and (2) of
subsection (a).
(c) Education on Significance of Early Detection.--The
Secretary may not make a grant under subsection (a) unless the
applicant involved agrees that, in carrying out subsection
(a)(3), the applicant will carry out education programs to
communicate to men, and to local health officials, the
significance of the early detection of prostate cancer.
(d) Requirement of Provision of All Services by Date
Certain.--The Secretary may not make a grant under subsection
(a) unless the applicant involved agrees--
(1) to ensure that, initially and throughout the
period during which amounts are received pursuant to
the grant, not less than 60 percent of the grant is
expended to provide each of the services or activities
described in paragraphs (1) and (2) of such subsection;
(2) to ensure that, by the end of any second fiscal
year of payments pursuant to the grant, each of the
services or activities described in such subsection is
provided; and
(3) to ensure that not more than 40 percent of the
grant is expended to provide the services or activities
described in paragraphs (3) through (6) of such section
\1\.
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\1\ So in law. Probably should be ``subsection''.
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(e) Additional Required Agreements.--
(1) Priority for low-income men.--The Secretary may
not make a grant under subsection (a) unless the
applicant involved agrees that low-income men, and men
at risk of prostate cancer, will be given priority in
the provision of services and activities pursuant to
paragraphs (1) and (2) of such subsection.
(2) Limitation on imposition of fees for
services.--The Secretary may not make a grant under
subsection (a) unless the applicant involved agrees
that, if a charge is imposed for the provision of
services or activities under the grant, such charge--
(A) will be made according to a schedule of
charges that is made available to the public;
(B) will be adjusted to reflect the income
of the man involved; and
(C) will not be imposed on any man with an
income of less than 100 percent of the official
poverty line, as established by the Director of
the Office of Management and Budget and revised
by the Secretary in accordance with section
673(2) of the Omnibus Budget Reconciliation Act
of 1981.
(3) Relationship to items and services under other
programs.--The Secretary may not make a grant under
subsection (a) unless the applicant involved agrees
that the grant will not be expended to make payment for
any item or service to the extent that payment has been
made, or can reasonably be expected to be made, with
respect to such item or service--
(A) under any State compensation program,
under an insurance policy, or under any Federal
or State health benefits program; or
(B) by an entity that provides health
services on a prepaid basis.
(4) Coordination with other prostate cancer
programs.--The Secretary may not make a grant under
subsection (a) unless the applicant involved agrees
that the services and activities funded through the
grant will be coordinated with other Federal, State,
and local prostate cancer programs.
(5) Limitation on administrative expenses.--The
Secretary may not make a grant under subsection (a)
unless the applicant involved agrees that not more than
10 percent of the grant will be expended for
administrative expenses with respect to the grant.
(6) Restrictions on use of grant.--The Secretary
may not make a grant under subsection (a) unless the
applicant involved agrees that the grant will not be
expended to provide inpatient hospital services for any
individual.
(7) Records and audits.--The Secretary may not make
a grant under subsection (a) unless the applicant
involved agrees that--
(A) the applicant will establish such
fiscal control and fund accounting procedures
as may be necessary to ensure the proper
disbursal of, and accounting for, amounts
received by the applicant under such section;
and
(B) upon request, the applicant will
provide records maintained pursuant to
paragraph (1) to the Secretary or the
Comptroller of the United States for purposes
of auditing the expenditures by the applicant
of the grant.
(f) Reports to Secretary.--The Secretary may not make a
grant under subsection (a) unless the applicant involved agrees
to submit to the Secretary such reports as the Secretary may
require with respect to the grant.
(g) Description of Intended Uses of Grant.--The Secretary
may not make a grant under subsection (a) unless--
(1) the applicant involved submits to the Secretary
a description of the purposes for which the applicant
intends to expend the grant;
(2) the description identifies the populations,
areas, and localities in the applicant \1\ with a need
for the services or activities described in subsection
(a);
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\1\ So in law.
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(3) the description provides information relating
to the services and activities to be provided,
including a description of the manner in which the
services and activities will be coordinated with any
similar services or activities of public or nonprivate
entities; and
(4) the description provides assurances that the
grant funds will be used in the most cost-effective
manner.
(h) Requirement of Submission of Application.--The
Secretary may not make a grant under subsection (a) unless an
application for the grant is submitted to the Secretary, the
application contains the description of intended uses required
in subsection (g), and the application is in such form, is made
in such manner, and contains such agreements, assurances, and
information as the Secretary determines to be necessary to
carry out this section.
(i) Method and Amount of Payment.--The Secretary shall
determine the amount of a grant made under subsection (a).
Payments under such grants may be made in advance on the basis
of estimates or by way of reimbursement, with necessary
adjustments on account of the underpayments or overpayments,
and in such installments and on such terms and conditions as
the Secretary finds necessary to carry out the purposes of such
grants.
(j) Technical Assistance and Provision of Supplies and
Services in Lieu of Grant Funds.--
(1) Technical assistance.--The Secretary may
provide training and technical assistance with respect
to the planning, development, and operation of any
program or service carried out pursuant to subsection
(a). The Secretary may provide such technical
assistance directly or through grants to, or contracts
with, public and private entities.
(2) Provision of supplies and services in lieu of
grant funds.--
(A) Upon the request of an applicant
receiving a grant under subsection (a), the
Secretary may, subject to subparagraph (B),
provide supplies, equipment, and services for
the purpose of aiding the applicant in carrying
out such section and, for such purpose, may
detail to the applicant any officer or employee
of the Department of Health and Human Services.
(B) With respect to a request described in
subparagraph (A), the Secretary shall reduce
the amount of payments under the grant under
subsection (a) to the applicant involved by an
amount equal to the costs of detailing
personnel (including pay, allowances, and
travel expenses) and the fair market value of
any supplies, equipment, or services provided
by the Secretary. The Secretary shall, for the
payment of expenses incurred in complying with
such request, expend the amounts withheld.
(k) Definition.--For purposes of this section, the term
``units of local government'' includes Indian tribes.
(l) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out
this section, there are authorized to be appropriated
$20,000,000 for fiscal year 1993, and such sums as may
be necessary for each of the fiscal years 1994 through
2004.
(2) Allocation for technical assistance.--Of the
amounts appropriated under paragraph (1) for a fiscal
year, the Secretary shall reserve not more than 20
percent for carrying out subsection (j)(1).
national strategy for combating and eliminating tuberculosis
Sec. 317E. [247b-6] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may make grants to States, political subdivisions,
and other public entities for preventive health service
programs for the prevention, control, and elimination of
tuberculosis.
(b) Research and Development; Demonstration Projects;
Education and Training.--With respect to the prevention,
treatment, control, and elimination of tuberculosis, the
Secretary may, directly or through grants to public or
nonprofit private entities, carry out the following:
(1) Research, with priority given to research and
development concerning latent tuberculosis infection,
strains of tuberculosis resistant to drugs, and
research concerning cases of tuberculosis that affect
certain populations at risk for tuberculosis.
(2) Research and development and related activities
to develop new tools for the elimination of
tuberculosis, including drugs, diagnostics, vaccines,
and public health interventions, such as directly
observed therapy and non-pharmaceutical intervention,
and methods to enhance detection and response to
outbreaks of tuberculosis, including multidrug
resistant tuberculosis. The Secretary is encouraged to
give priority to programmatically relevant research so
that new tools can be utilized in public health
practice.
(3) Demonstration projects for--
(A) the development of regional
capabilities to prevent, control, and eliminate
tuberculosis and prevent multidrug resistant
and extensively drug resistant strains of
tuberculosis;
(B) the intensification of efforts to
reduce health disparities in the incidence of
tuberculosis;
(C) the intensification of efforts to
control tuberculosis along the United States-
Mexico border and among United States-Mexico
binational populations, including through
expansion of the scope and number of programs
that--
(i) detect and treat binational
cases of tuberculosis; and
(ii) treat high-risk cases of
tuberculosis referred from Mexican
health departments;
(D) the intensification of efforts to
prevent, detect, and treat tuberculosis among
foreign-born persons who are in the United
States;
(E) the intensification of efforts to
prevent, detect, and treat tuberculosis among
populations and settings documented as having a
high risk for tuberculosis; and
(F) tuberculosis detection, control, and
prevention.
(4) Public information and education activities.
(5) Education, training, clinical skills
improvement activities, and workplace exposure
prevention for health professionals, including allied
health personnel and emergency response employees.
(6) Support of Centers to carry out activities
under paragraphs (1) through (4).
(7) Collaboration with international organizations
and foreign countries in carrying out such activities.
(8) Develop, enhance, and expand information
technologies that support tuberculosis control
including surveillance and database management systems
with cross-jurisdictional capabilities, which shall
conform to the standards and implementation
specifications for such information technologies as
recommended by the Secretary.
(c) Cooperation With Providers of Primary Health
Services.--The Secretary may make a grant under subsection (a)
or (b) only if the applicant for the grant agrees that, in
carrying out activities under the grant, the applicant will
cooperate with public and nonprofit private providers of
primary health services or substance abuse services, including
entities receiving assistance under section 329, 330, or 340A
or under title V or XIX.
(d) Application for Grant.--
(1) In general.--The Secretary may make a grant
under subsection (a) or (b) only if an application for
the grant is submitted to the Secretary and the
application, subject to paragraph (2), is in such form,
is made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out the subsection involved.
(2) Plan for prevention, control, and
elimination.--The Secretary may make a grant under
subsection (a) only if the application under paragraph
(1) contains a plan regarding the prevention, control,
and elimination of tuberculosis in the geographic area
with respect to which the grant is sought.
(3) Determination of amount of nonfederal
contributions.--
(A) Priority.--In awarding grants under
subsection (a) or (b), the Secretary shall give
highest priority to an applicant that provides
assurances that the applicant will contribute
non-Federal funds to carry out activities under
this section, which may be provided directly or
through donations from public or private
entities and may be in cash or in kind,
including equipment or services.
(B) Federal amounts not to be included as
contributions.--Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of non-Federal contributions as
described in subparagraph (A).
(e) Supplies and Services in Lieu of Grant Funds.--
(1) In general.--Upon the request of a grantee
under subsection (a) or (b), the Secretary may, subject
to paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the grantee in
carrying out the subsection involved and, for such
purpose, may detail to the State any officer or
employee of the Department of Health and Human
Services.
(2) Corresponding reduction in payments.--With
respect to a request described in paragraph (1), the
Secretary shall reduce the amount of payments under the
grant involved by an amount equal to the costs of
detailing personnel and the fair market value of any
supplies, equipment, or services provided by the
Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request,
expend the amounts withheld.
(f) Advisory Council.--
(1) In general.--The Secretary shall establish an
advisory council to be known as the Advisory Council
for the Elimination of Tuberculosis (in this subsection
referred to as the ``Council'').
(2) Duties.--The Council shall provide advice and
recommendations regarding the elimination of
tuberculosis to the Secretary. In addition, the Council
shall, with respect to eliminating such disease,
provide to the Secretary and other appropriate Federal
officials advice on--
(A) coordinating the activities of the
Department of Health and Human Services and
other Federal agencies that relate to the
disease, including activities under subsection
(b);
(B) responding rapidly and effectively to
emerging issues in tuberculosis; and
(C) efficiently utilizing the Federal
resources involved.
(3) Comprehensive plan.--
(A) In general.--In carrying out paragraph
(2), the Council shall make or update
recommendations on the development, revision,
and implementation of a comprehensive plan to
eliminate tuberculosis in the United States.
(B) Consultation.--In carrying out
subparagraph (A), the Council may consult with
appropriate public and private entities, which
may, subject to the direction or discretion of
the Secretary, include--
(i) individuals who are scientists,
physicians, laboratorians, and other
health professionals, who are not
officers or employees of the Federal
Government and who represent the
disciplines relevant to tuberculosis
elimination;
(ii) members of public-private
partnerships or private entities
established to address the elimination
of tuberculosis;
(iii) members of national and
international nongovernmental
organizations whose purpose is to
eliminate tuberculosis;
(iv) members from the general
public who are knowledgeable with
respect to tuberculosis elimination
including individuals who have or have
had tuberculosis; and
(v) scientists, physicians,
laboratorians, and other health
professionals who reside in a foreign
country with a substantial incidence or
prevalence of tuberculosis, and who
represent the specialties and
disciplines relevant to the research
under consideration.
(C) Certain components of plan.--In
carrying out subparagraph (A), the Council
shall, subject to the direction or discretion
of the Secretary--
(i) consider recommendations for
the involvement of the United States in
continuing global and cross-border
tuberculosis control activities in
countries where a high incidence of
tuberculosis directly affects the
United States; and
(ii) review the extent to which
progress has been made toward
eliminating tuberculosis.
(4) Biennial report.--
(A) In general.--The Council shall submit a
biennial report to the Secretary, as determined
necessary by the Secretary, on the activities
carried under this section. Each such report
shall include the opinion of the Council on the
extent to which its recommendations regarding
the elimination of tuberculosis have been
implemented, including with respect to--
(i) activities under subsection
(b); and
(ii) the national plan referred to
in paragraph (3).
(B) Public.--The Secretary shall make a
report submitted under subparagraph (A) public.
(5) Composition.--The Council shall be composed
of--
(A) ex officio representatives from the
Centers for Disease Control and Prevention, the
National Institutes of Health, the United
States Agency for International Development,
the Agency for Healthcare Research and Quality,
the Health Resources and Services
Administration, the United States-Mexico Border
Health Commission, and other Federal
departments and agencies that carry out
significant activities related to tuberculosis;
(B) State and local tuberculosis control
and public health officials;
(C) individuals who are scientists,
physicians, laboratorians, and other health
professionals who represent disciplines
relevant to tuberculosis elimination; and
(D) members of national and international
nongovernmental organizations established to
address the elimination of tuberculosis.
(6) Staff, information, and other assistance.--The
Secretary shall provide to the Council such staff,
information, and other assistance as may be necessary
to carry out the duties of the Council.
(g) Federal Tuberculosis Task Force.--
(1) Duties.--The Federal Tuberculosis Task Force
(in this subsection referred to as the ``Task Force'')
shall provide to the Secretary and other appropriate
Federal officials advice on research into new tools
under subsection (b)(2), including advice regarding the
efficient utilization of the Federal resources
involved.
(2) Comprehensive plan for new tools development.--
In carrying out paragraph (1), the Task Force shall
make recommendations on the development of a
comprehensive plan for the creation of new tools for
the elimination of tuberculosis, including drugs,
diagnostics, and vaccines.
(3) Consultation.--In developing the comprehensive
plan under paragraph (1), the Task Force shall consult
with external parties including representatives from
groups such as--
(A) scientists, physicians, laboratorians,
and other health professionals who represent
the specialties and disciplines relevant to the
research under consideration;
(B) members from public-private
partnerships, private entities, or foundations
(or both) engaged in activities relevant to
research under consideration;
(C) members of national and international
nongovernmental organizations established to
address tuberculosis elimination;
(D) members from the general public who are
knowledgeable with respect to tuberculosis
including individuals who have or have had
tuberculosis; and
(E) scientists, physicians, laboratorians,
and other health professionals who reside in a
foreign country with a substantial incidence or
prevalence of tuberculosis, and who represent
the specialties and disciplines relevant to the
research under consideration.
(h) Authorization of Appropriations.--
(1) General program.--
(A) In general.--For the purpose of
carrying out this section, there are authorized
to be appropriated $200,000,000 for fiscal year
2009, $210,000,000 for fiscal year 2010,
$220,500,000 for fiscal year 2011, $231,525,000
for fiscal year 2012, and $243,101,250 for
fiscal year 2013.
(B) Reservation for emergency grants.--Of
the amounts appropriated under subparagraph (A)
for a fiscal year, the Secretary may reserve
not more than 25 percent for emergency grants
under subsection (a) for any geographic area,
State, political subdivision of a State, or
other public entity in which there is, relative
to other areas, a substantial number of cases
of tuberculosis, multidrug resistant
tuberculosis, or extensively drug resistant
tuberculosis or a substantial rate of increase
in such cases.
(C) Priority.--In allocating amounts
appropriated under subparagraph (A), the
Secretary shall give priority to allocating
such amounts for grants under subsection (a).
(D) Allocation of funds.--
(i) Requirement of formula.--Of the
amounts appropriated under subparagraph
(A), not reserved under subparagraph
(B), and allocated by the Secretary for
grants under subsection (a), the
Secretary shall distribute a portion of
such amounts to grantees under
subsection (a) on the basis of a
formula.
(ii) Relevant factors.--The formula
developed by the Secretary under clause
(i) shall take into account the level
of tuberculosis morbidity and case
complexity in the respective geographic
area and may consider other factors
relevant to tuberculosis in such area.
(iii) No change to formula
required.--This subparagraph does not
require the Secretary to modify the
formula that was used by the Secretary
to distribute funds to grantees under
subsection (a) for fiscal year 2009.
(2) Limitation.--The authorization of
appropriations established in paragraph (1) for a
fiscal year is effective only if the amount
appropriated under such paragraph for such year equals
or exceeds the amount appropriated to carry out this
section for fiscal year 2009.
loan repayment program
Sec. 317F. [247b-7] (a) In General.--
(1) Authority.--Subject to paragraph (2), the
Secretary may carry out a program of entering into
contracts with appropriately qualified health
professionals under which such health professionals
agree to conduct prevention activities, as employees of
the Centers for Disease Control and Prevention and the
Agency for Toxic Substances and Disease Registry, in
consideration of the Federal Government agreeing to
repay, for each year of such service, not more than
$35,000 of the principal and interest of the
educational loans of such health professionals.
(2) Limitation.--The Secretary may not enter into
an agreement with a health professional pursuant to
paragraph (1) unless such professional--
(A) has a substantial amount of educational
loans relative to income; and
(B) agrees to serve as an employee of the
Centers for Disease Control and Prevention or
the Agency for Toxic Substances and Disease
Registry for purposes of paragraph (1) for a
period of not less than 3 years.
(b) Applicability of Certain Provisions.--With respect to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III of this Act,
the provisions of such subpart shall, except as inconsistent
with subsection (a), apply to the program established in this
section in the same manner and to the same extent as such
provisions apply to the National Health Service Corps Loan
Repayment Program.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $500,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 through
2002.
(d) Availability of Appropriations.--Amounts appropriated
for a fiscal year for contracts under subsection (a) shall
remain available until the expiration of the second fiscal year
beginning after the fiscal year for which the amounts were
appropriated.
SEC. 317G. [247B-8] FELLOWSHIP AND TRAINING PROGRAMS.
The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall establish fellowship
and training programs to be conducted by such Centers to train
individuals to develop skills in epidemiology, surveillance,
laboratory analysis, and other disease detection and prevention
methods. Such programs shall be designed to enable health
professionals and health personnel trained under such programs
to work, after receiving such training, in local, State,
national, and international efforts toward the prevention and
control of diseases, injuries, and disabilities. Such
fellowships and training may be administered through the use of
either appointment or nonappointment procedures.
diabetes in children and youth
Sec. 317H. [247b-9] (a) Surveillance on Juvenile
Diabetes.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall develop a
sentinel system to collect data on juvenile diabetes, including
with respect to incidence and prevalence, and shall establish a
national database for such data.
(b) Type 2 Diabetes in Youth.--The Secretary shall
implement a national public health effort to address type 2
diabetes in youth, including--
(1) enhancing surveillance systems and expanding
research to better assess the prevalence and incidence
of type 2 diabetes in youth and determine the extent to
which type 2 diabetes is incorrectly diagnosed as type
1 diabetes among children; and
(2) developing and improving laboratory methods to
assist in diagnosis, treatment, and prevention of
diabetes including, but not limited to, developing
noninvasive ways to monitor blood glucose to prevent
hypoglycemia and improving existing glucometers that
measure blood glucose.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
compilation of data on asthma
Sec. 317I. [247b-10] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall--
(1) conduct local asthma surveillance activities to
collect data on the prevalence and severity of asthma
and the quality of asthma management;
(2) compile and annually publish data on the
prevalence of children suffering from asthma in each
State; and
(3) to the extent practicable, compile and publish
data on the childhood mortality rate associated with
asthma nationally.
(b) Surveillance Activities.--The Director of the Centers
for Disease Control and Prevention, acting through the
representative of the Director on the National Asthma Education
Prevention Program Coordinating Committee, shall, in carrying
out subsection (a), provide an update on surveillance
activities at each Committee meeting.
(c) Collaborative Efforts.--The activities described in
subsection (a)(1) may be conducted in collaboration with
eligible entities awarded a grant under section 399L.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
effects of folic acid in prevention of birth defects
Sec. 317J. [247b-11] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall expand and intensify programs (directly or
through grants or contracts) for the following purposes:
(1) To provide education and training for health
professionals and the general public for purposes of
explaining the effects of folic acid in preventing
birth defects and for purposes of encouraging each
woman of reproductive capacity (whether or not planning
a pregnancy) to consume on a daily basis a dietary
supplement that provides an appropriate level of folic
acid.
(2) To conduct research with respect to such
education and training, including identifying effective
strategies for increasing the rate of consumption of
folic acid by women of reproductive capacity.
(3) To conduct research to increase the
understanding of the effects of folic acid in
preventing birth defects, including understanding with
respect to cleft lip, cleft palate, and heart defects.
(4) To provide for appropriate epidemiological
activities regarding folic acid and birth defects,
including epidemiological activities regarding neural
tube defects.
(b) Consultations With States and Private Entities.--In
carrying out subsection (a), the Secretary shall consult with
the States and with other appropriate public or private
entities, including national nonprofit private organizations,
health professionals, and providers of health insurance and
health plans.
(c) Technical Assistance.--The Secretary may (directly or
through grants or contracts) provide technical assistance to
public and nonprofit private entities in carrying out the
activities described in subsection (a).
(d) Evaluations.--The Secretary shall (directly or through
grants or contracts) provide for the evaluation of activities
under subsection (a) in order to determine the extent to which
such activities have been effective in carrying out the
purposes of the program under such subsection, including the
effects on various demographic populations. Methods of
evaluation under the preceding sentence may include surveys of
knowledge and attitudes on the consumption of folic acid and on
blood folate levels. Such methods may include complete and
timely monitoring of infants who are born with neural tube
defects.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
safe motherhood
Sec. 317K. [247b-12] (a) Surveillance.--
(1) Purpose.--The purpose of this subsection is to
develop surveillance systems at the local, State, and
national level to better understand the burden of
maternal complications and mortality and to decrease
the disparities among population at risk of death and
complications from pregnancy.
(2) Activities.--For the purpose described in
paragraph (1), the Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may carry out the following activities:
(A) The Secretary may establish and
implement a national surveillance program to
identify and promote the investigation of
deaths and severe complications that occur
during pregnancy.
(B) The Secretary may expand the Pregnancy
Risk Assessment Monitoring System to provide
surveillance and collect data in each State.
(C) The Secretary may expand the Maternal
and Child Health Epidemiology Program to
provide technical support, financial
assistance, or the time-limited assignment of
senior epidemiologists to maternal and child
health programs in each State.
(b) Prevention Research.--
(1) Purpose.--The purpose of this subsection is to
provide the Secretary with the authority to further
expand research concerning risk factors, prevention
strategies, and the roles of the family, health care
providers and the community in safe motherhood.
(2) Research.--The Secretary may carry out
activities to expand research relating to--
(A) encouraging preconception counseling,
especially for at risk populations such as
diabetics;
(B) the identification of critical
components of prenatal delivery and postpartum
care;
(C) the identification of outreach and
support services, such as folic acid education,
that are available for pregnant women;
(D) the identification of women who are at
high risk for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean
sections;
(H) an examination of the higher rates of
maternal mortality among African American
women;
(I) an examination of the relationship
between domestic violence and maternal
complications and mortality;
(J) preventing and reducing adverse health
consequences that may result from smoking,
alcohol and illegal drug use before, during and
after pregnancy;
(K) preventing infections that cause
maternal and infant complications; and
(L) other areas determined appropriate by
the Secretary.
(c) Prevention Programs.--
(1) \1\ In general.--The Secretary may carry out
activities to promote safe motherhood, including--
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\1\So in law. Subsection (c) does not contain a paragraph (2). See
section 901 of Public Law 106-310 (114 Stat. 1126).
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(A) public education campaigns on healthy
pregnancies and the building of partnerships
with outside organizations concerned about safe
motherhood;
(B) education programs for physicians,
nurses and other health care providers; and
(C) activities to promote community support
services for pregnant women.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
prenatal and postnatal health
Sec. 317L. [247b-13] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall carry out programs--
(1) to collect, analyze, and make available data on
prenatal smoking, alcohol and illegal drug use,
including data on the implications of such activities
and on the incidence and prevalence of such activities
and their implications;
(2) to conduct applied epidemiological research on
the prevention of prenatal and postnatal smoking,
alcohol and illegal drug use;
(3) to support, conduct, and evaluate the
effectiveness of educational and cessation programs;
and
(4) to provide information and education to the
public on the prevention and implications of prenatal
and postnatal smoking, alcohol and illegal drug use.
(b) Grants.--In carrying out subsection (a), the Secretary
may award grants to and enter into contracts with States, local
governments, scientific and academic institutions, federally
qualified health centers, and other public and nonprofit
entities, and may provide technical and consultative assistance
to such entities.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
oral health promotion and disease prevention
Sec. 317M. [247b-14] (a) Grants to Increase Resources for
Community Water Fluoridation.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may make grants to States and Indian tribes
for the purpose of increasing the resources available
for community water fluoridation.
(2) Use of funds.--A State shall use amounts
provided under a grant under paragraph (1)--
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on the
benefits of fluoridation; or
(D) to support the infrastructure necessary
to monitor and maintain the quality of water
fluoridation.
(b) Community Water Fluoridation.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention and in collaboration with the Director of
the Indian Health Service, shall establish a
demonstration project that is designed to assist rural
water systems in successfully implementing the water
fluoridation guidelines of the Centers for Disease
Control and Prevention that are entitled ``Engineering
and Administrative Recommendations for Water
Fluoridation, 1995'' (referred to in this subsection as
the ``EARWF'').
(2) Requirements.--
(A) Collaboration.--In collaborating under
paragraph (1), the Directors referred to in
such paragraph shall ensure that technical
assistance and training are provided to tribal
programs located in each of the 12 areas of the
Indian Health Service. The Director of the
Indian Health Service shall provide
coordination and administrative support to
tribes under this section.
(B) General use of funds.--Amounts made
available under paragraph (1) shall be used to
assist small water systems in improving the
effectiveness of water fluoridation and to meet
the recommendations of the EARWF.
(C) Fluoridation specialists.--
(i) In general.--In carrying out
this subsection, the Secretary shall
provide for the establishment of
fluoridation specialist engineering
positions in each of the Dental
Clinical and Preventive Support Centers
through which technical assistance and
training will be provided to tribal
water operators, tribal utility
operators and other Indian Health
Service personnel working directly with
fluoridation projects.
(ii) Liaison.--A fluoridation
specialist shall serve as the principal
technical liaison between the Indian
Health Service and the Centers for
Disease Control and Prevention with
respect to engineering and fluoridation
issues.
(iii) CDC.--The Director of the
Centers for Disease Control and
Prevention shall appoint individuals to
serve as the fluoridation specialists.
(D) Implementation.--The project
established under this subsection shall be
planned, implemented and evaluated over the 5-
year period beginning on the date on which
funds are appropriated under this section and
shall be designed to serve as a model for
improving the effectiveness of water
fluoridation systems of small rural
communities.
(3) Evaluation.--In conducting the ongoing
evaluation as provided for in paragraph (2)(D), the
Secretary shall ensure that such evaluation includes--
(A) the measurement of changes in water
fluoridation compliance levels resulting from
assistance provided under this section;
(B) the identification of the
administrative, technical and operational
challenges that are unique to the fluoridation
of small water systems;
(C) the development of a practical model
that may be easily utilized by other tribal,
State, county or local governments in improving
the quality of water fluoridation with emphasis
on small water systems; and
(D) the measurement of any increased
percentage of Native Americans or Alaskan
Natives who receive the benefits of optimally
fluoridated water.
(c) School-Based Dental Sealant Program.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention and in collaboration with the Administrator
of the Health Resources and Services Administration,
shall award a grant to each of the 50 States and
territories and to Indians, Indian tribes, tribal
organizations and urban Indian organizations (as such
terms are defined in section 4 of the Indian Health
Care Improvement Act) to provide for the development of
school-based dental sealant programs to improve the
access of children to sealants.
(2) Use of funds.--A State shall use amounts
received under a grant under paragraph (1) to provide
funds to eligible school-based entities or to public
elementary or secondary schools to enable such entities
or schools to provide children with access to dental
care and dental sealant services. Such services shall
be provided by licensed dental health professionals in
accordance with State practice licensing laws.
(3) Eligibility.--To be eligible to receive funds
under paragraph (1), an entity shall--
(A) prepare and submit to the State an
application at such time, in such manner and
containing such information as the State may
require; and
(B) be a public elementary or secondary
school--
(i) that is located in an urban
area in which and more than 50 percent
of the student population is
participating in Federal or State free
or reduced meal programs; or
(ii) that is located in a rural
area and, with respect to the school
district in which the school is
located, the district involved has a
median income that is at or below 235
percent of the poverty line, as defined
in section 673(2) of the Community
Services Block Grant Act (42 U.S.C.
9902(2)).
(d) Oral Health Infrastructure.--
(1) Cooperative agreements.--The Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall enter into cooperative agreements
with State, territorial, and Indian tribes or tribal
organizations (as those terms are defined in section 4
of the Indian Health Care Improvement Act) to establish
oral health leadership and program guidance, oral
health data collection and interpretation, (including
determinants of poor oral health among vulnerable
populations), a multi-dimensional delivery system for
oral health, and to implement science-based programs
(including dental sealants and community water
fluoridation) to improve oral health.
(2) Authorization of appropriations.--There is
authorized to be appropriated such sums as necessary to
carry out this subsection for fiscal years 2010 through
2014.
(e) Definitions.--For purposes of this section, the term
``Indian tribe'' means an Indian tribe or tribal organization
as defined in section 4(b) and section 4(c) of the Indian Self-
Determination and Education Assistance Act.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
surveillance and education regarding hepatitis c virus
Sec. 317N. [247b-15] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may (directly and through grants to public and
nonprofit private entities) provide for programs to carry out
the following:
(1) To cooperate with the States in implementing a
national system to determine the incidence of hepatitis
C virus infection (in this section referred to as ``HCV
infection'') and to assist the States in determining
the prevalence of such infection, including the
reporting of chronic HCV cases.
(2) To identify, counsel, and offer testing to
individuals who are at risk of HCV infection as a
result of receiving blood transfusions prior to July
1992, or as a result of other risk factors.
(3) To provide appropriate referrals for
counseling, testing, and medical treatment of
individuals identified under paragraph (2) and to
ensure, to the extent practicable, the provision of
appropriate follow-up services.
(4) To develop and disseminate public information
and education programs for the detection and control of
HCV infection, with priority given to high risk
populations as determined by the Secretary.
(5) To improve the education, training, and skills
of health professionals in the detection and control of
HCV infection, with priority given to pediatricians and
other primary care physicians, and obstetricians and
gynecologists.
(b) Laboratory Procedures.--The Secretary may (directly and
through grants to public and nonprofit private entities) carry
out programs to provide for improvements in the quality of
clinical-laboratory procedures regarding hepatitis C, including
reducing variability in laboratory results on hepatitis C
antibody and PCR testing.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
grants for lead poisoning related activities
Sec. 317O. [247b-16] (a) Authority To Make Grants.--
(1) In general.--The Secretary shall make grants to
States to support public health activities in States
and localities where data suggests that at least 5
percent of preschool-age children have an elevated
blood lead level through--
(A) effective, ongoing outreach and
community education targeted to families most
likely to be at risk for lead poisoning;
(B) individual family education activities
that are designed to reduce ongoing exposures
to lead for children with elevated blood lead
levels, including through home visits and
coordination with other programs designed to
identify and treat children at risk for lead
poisoning; and
(C) the development, coordination and
implementation of community-based approaches
for comprehensive lead poisoning prevention
from surveillance to lead hazard control.
(2) State match.--A State is not eligible for a
grant under this section unless the State agrees to
expend (through State or local funds) $1 for every $2
provided under the grant to carry out the activities
described in paragraph (1).
(3) Application.--To be eligible to receive a grant
under this section, a State shall submit an application
to the Secretary in such form and manner and containing
such information as the Secretary may require.
(b) Coordination With Other Children's Programs.--A State
shall identify in the application for a grant under this
section how the State will coordinate operations and activities
under the grant with--
(1) other programs operated in the State that serve
children with elevated blood lead levels, including any
such programs operated under title V, XIX, or XXI of
the Social Security Act; and
(2) one or more of the following--
(A) the child welfare and foster care and
adoption assistance programs under parts B and
E of title IV of such Act;
(B) the head start program established
under the Head Start Act (42 U.S.C. 9831 et
seq.);
(C) the program of assistance under the
special supplemental nutrition program for
women, infants and children (WIC) under section
17 of the Child Nutrition Act of 1966 (42
U.S.C. 1786);
(D) local public and private elementary or
secondary schools; or
(E) public housing agencies, as defined in
section 3 of the United States Housing Act of
1937 (42 U.S.C. 1437a).
(c) Performance Measures.--The Secretary shall establish
needs indicators and performance measures to evaluate the
activities carried out under grants awarded under this section.
Such indicators shall be commensurate with national measures of
maternal and child health programs and shall be developed in
consultation with the Director of the Centers for Disease
Control and Prevention.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.
HUMAN PAPILLOMAVIRUS (JOHANNA'S LAW) \1\
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\1\ The typeface of the parenthetical matter in the section heading
probably should appear in light face and all small caps.
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Sec. 317P. [247b-17] (a) Surveillance .--
(1) In general.--The Secretary, acting through the
Centers for Disease Control and Prevention, shall--
(A) enter into cooperative agreements with
States and other entities to conduct sentinel
surveillance or other special studies that
would determine the prevalence in various age
groups and populations of specific types of
human papillomavirus (referred to in this
section as ``HPV'') in different sites in
various regions of the United States, through
collection of special specimens for HPV using a
variety of laboratory-based testing and
diagnostic tools; and
(B) develop and analyze data from the HPV
sentinel surveillance system described in
subparagraph (A).
(2) Report.--The Secretary shall make a progress
report to the Congress with respect to paragraph (1) no
later than 1 year after the effective date of this
section.
(b) Prevention Activities; Education Program.--
(1) In general.--The Secretary, acting through the
Centers for Disease Control and Prevention, shall
conduct prevention research on HPV, including--
(A) behavioral and other research on the
impact of HPV-related diagnosis on individuals;
(B) formative research to assist with the
development of educational messages and
information for the public, for patients, and
for their partners about HPV;
(C) surveys of physician and public
knowledge, attitudes, and practices about
genital HPV infection; and
(D) upon the completion of and based on the
findings under subparagraphs (A) through (C),
develop and disseminate educational materials
for the public and health care providers
regarding HPV and its impact and prevention.
(2) Report; final proposal.--The Secretary shall
make a progress report to the Congress with respect to
paragraph (1) not later than 1 year after the effective
date of this section, and shall develop a final report
not later than 3 years after such effective date,
including a detailed summary of the significant
findings and problems and the best strategies to
prevent future infections, based on available science.
(c) HPV Education and Prevention.--
(1) In general.--The Secretary shall prepare and
distribute educational materials for health care
providers and the public that include information on
HPV. Such materials shall address--
(A) modes of transmission;
(B) consequences of infection, including
the link between HPV and cervical cancer;
(C) the available scientific evidence on
the effectiveness or lack of effectiveness of
condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears,
and other diagnostics for early intervention
and prevention of cervical cancer purposes in
preventing cervical cancer.
(2) Medically accurate information.--Educational
material under paragraph (1), and all other relevant
educational and prevention materials prepared and
printed from this date forward for the public and
health care providers by the Secretary (including
materials prepared through the Food and Drug
Administration, the Centers for Disease Control and
Prevention, and the Health Resources and Services
Administration), or by contractors, grantees, or
subgrantees thereof, that are specifically designed to
address STDs including HPV shall contain medically
accurate information regarding the effectiveness or
lack of effectiveness of condoms in preventing the STD
the materials are designed to address. Such requirement
only applies to materials mass produced for the public
and health care providers, and not to routine
communications.
(d) Johanna's Law.--
(1) National public awareness campaign.--
(A) In general.--The Secretary shall carry
out a national campaign to increase the
awareness and knowledge of health care
providers and women with respect to gynecologic
cancers.
(B) Written materials.--Activities under
the national campaign under subparagraph (A)
shall include--
(i) maintaining a supply of written
materials that provide information to
the public on gynecologic cancers; and
(ii) distributing the materials to
members of the public upon request.
(C) Public service announcements.--
Activities under the national campaign under
subparagraph (A) shall, in accordance with
applicable law and regulations, include
developing and placing, in telecommunications
media, public service announcements intended to
encourage women to discuss with their
physicians their risks of gynecologic cancers.
Such announcements shall inform the public on
the manner in which the written materials
referred to in subparagraph (B) can be obtained
upon request, and shall call attention to early
warning signs and risk factors based on the
best available medical information.
(2) Report and strategy.--
(A) Report.--Not later than 6 months after
the date of the enactment of this subsection,
the Secretary shall submit to the Congress a
report including the following:
(i) A description of the past and
present activities of the Department of
Health and Human Services to increase
awareness and knowledge of the public
with respect to different types of
cancer, including gynecologic cancers.
(ii) A description of the past and
present activities of the Department of
Health and Human Services to increase
awareness and knowledge of health care
providers with respect to different
types of cancer, including gynecologic
cancers.
(iii) For each activity described
pursuant to clause (i) or (ii), a
description of the following:
(I) The funding for such
activity for fiscal year 2006
and the cumulative funding for
such activity for previous
fiscal years.
(II) The background and
history of such activity,
including--
(aa) the goals of
such activity;
(bb) the
communications
objectives of such
activity;
(cc) the identity
of each agency within
the Department of
Health and Human
Services responsible
for any aspect of the
activity; and
(dd) how such
activity is or was
expected to result in
change.
(III) How long the activity
lasted or is expected to last.
(IV) The outcomes observed
and the evaluation methods, if
any, that have been, are being,
or will be used with respect to
such activity.
(V) For each such outcome
or evaluation method, a
description of the associated
results, analyses, and
conclusions.
(B) Strategy.--
(i) Development; submission to
congress.--Not later than 3 months
after submitting the report required by
subparagraph (A), the Secretary shall
develop and submit to the Congress a
strategy for improving efforts to
increase awareness and knowledge of the
public and health care providers with
respect to different types of cancer,
including gynecological cancers.
(ii) Consultation.--In developing
the strategy under clause (i), the
Secretary should consult with qualified
private sector groups, including
nonprofit organizations.
(3) Full compliance.--
(A) In general.--Not later than March 1,
2008, the Secretary shall ensure that all
provisions of this section, including
activities directed to be carried out by the
Centers for Disease Control and Prevention and
the Food and Drug Administration, are fully
implemented and being complied with. Not later
than April 30, 2008, the Secretary shall submit
to Congress a report that certifies compliance
with the preceding sentence and that contains a
description of all activities undertaken to
achieve such compliance.
(B) If the Secretary fails to submit the
certification as provided for under
subparagraph (A), the Secretary shall, not
later than 3 months after the date on which the
report is to be submitted under subparagraph
(A), and every 3 months thereafter, submit to
Congress an explanation as to why the Secretary
has not yet complied with the first sentence of
subparagraph (A), a detailed description of all
actions undertaken within the month for which
the report is being submitted to bring the
Secretary into compliance with such sentence,
and the anticipated date the Secretary expects
to be in full compliance with such sentence.
(4) Consultation with nonprofit gynecologic cancer
organizations.--In carrying out the national campaign
under this subsection, the Secretary shall consult with
nonprofit gynecologic cancer organizations, with a
mission both to conquer ovarian or other gynecologic
cancer and to provide outreach to State and local
governments and communities, for the purpose of
determining the best practices for providing
gynecologic cancer information and outreach services to
varied populations.
(6) Authorization of appropriations.--For the
purpose of carrying out this subsection, there is
authorized to be appropriated $16,500,000 for the
period of fiscal years 2007 through 2009 and
$18,000,000 for the period of fiscal years 2012 through
2014.
SEC. 317Q. [247B-18] SURVEILLANCE AND RESEARCH REGARDING MUSCULAR
DYSTROPHY.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may award
grants and cooperative agreements to public or nonprofit
private entities (including health departments of States and
political subdivisions of States, and including universities
and other educational entities) for the collection, analysis,
and reporting of data on Duchenne and other forms of muscular
dystrophy. In making such awards, the Secretary may provide
direct technical assistance in lieu of cash.
(b) National Muscular Dystrophy Epidemiology Program.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, may award grants to public or
nonprofit private entities (including health departments of
States and political subdivisions of States, and including
universities and other educational entities) for the purpose of
carrying out epidemiological activities regarding Duchenne and
other forms of muscular dystrophies, including collecting and
analyzing information on the number, incidence, correlates, and
symptoms of cases. In carrying out the preceding sentence, the
Secretary shall provide for a national surveillance program. In
making awards under this subsection, the Secretary may provide
direct technical assistance in lieu of cash.
(c) Coordination With Centers of Excellence.--The Secretary
shall ensure that epidemiological information under subsections
(a) and (b) is made available to centers of excellence
supported under section 404E(b) by the Director of the National
Institutes of Health.
(d) Data.--In carrying out this section, the Secretary may
ensure that any data on patients that is collected as part of
the Muscular Dystrophy STARnet (under a grant under this
section) is regularly updated to reflect changes in patient
condition over time.
(e) Reports and Study.--
(1) Annual report.--Not later than 18 months after
the date of the enactment of the Paul D. Wellstone
Muscular Dystrophy Community Assistance, Research, and
Education Amendments of 2008, and annually thereafter,
the Director of the Centers for Disease Control and
Prevention shall submit to the appropriate committees
of the Congress a report--
(A) concerning the activities carried out
by MD STARnet site \1\ funded under this
section during the year for which the report is
prepared;
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\1\ So in law. The term ``site'' probably should be ``sites''.
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(B) containing the data collected and
findings derived from the MD STARnet sites each
fiscal year (as funded under a grant under this
section during fiscal years 2008 through 2012);
and
(C) that every 2 years outlines prospective
data collection objectives and strategies.
(2) Tracking health outcomes.--The Secretary may
provide health outcome data on the health and survival
of people with muscular dystrophy.
(f) Authorization of Appropriations.--There are authorized
to be appropriated such sums as may be necessary to carry out
this section.
SEC. 317R. [247B-20] FOOD SAFETY GRANTS.
(a) In General.--The Secretary may award grants to States
and Indian tribes (as defined in section 4(e) of the Indian
Self-Determination and Education Assistance Act (25 U.S.C.
450b(e))) to expand participation in networks to enhance
Federal, State, and local food safety efforts, including
meeting the costs of establishing and maintaining the food
safety surveillance, technical, and laboratory capacity needed
for such participation.
(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $19,500,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2006.
SEC. 317S. [247B-21] MOSQUITO-BORNE DISEASES; COORDINATION GRANTS TO
STATES; ASSESSMENT AND CONTROL GRANTS TO POLITICAL
SUBDIVISIONS.
(a) Coordination Grants to States; Assessment Grants to
Political Subdivisions.--
(1) In general.--With respect to mosquito control
programs to prevent and control mosquito-borne diseases
(referred to in this section as ``control programs''),
the Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may make
grants to States for the purpose of--
(A) coordinating control programs in the
State involved; and
(B) assisting such State in making grants
to political subdivisions of the State to
conduct assessments to determine the immediate
needs in such subdivisions for control
programs, and to develop, on the basis of such
assessments, plans for carrying out control
programs in the subdivisions.
(2) Preference in making grants.--In making grants
under paragraph (1), the Secretary shall give
preference to States that have one or more political
subdivisions with an incidence, prevalence, or high
risk of mosquito-borne disease, or a population of
infected mosquitoes, that is substantial relative to
political subdivisions in other States.
(3) Certain requirements.--A grant may be made
under paragraph (1) only if--
(A) the State involved has developed, or
agrees to develop, a plan for coordinating
control programs in the State, and the plan
takes into account any assessments or plans
described in subsection (b)(3) that have been
conducted or developed, respectively, by
political subdivisions in the State;
(B) in developing such plan, the State
consulted or will consult (as the case may be
under subparagraph (A)) with political
subdivisions in the State that are carrying out
or planning to carry out control programs;
(C) the State agrees to monitor control
programs in the State in order to ensure that
the programs are carried out in accordance with
such plan, with priority given to coordination
of control programs in political subdivisions
described in paragraph (2) that are contiguous;
(D) the State agrees that the State will
make grants to political subdivisions as
described in paragraph (1)(B), and that such a
grant will not exceed $10,000; and
(E) the State agrees that the grant will be
used to supplement, and not supplant, State and
local funds available for the purpose described
in paragraph (1).
(4) Reports to secretary.--A grant may be made
under paragraph (1) only if the State involved agrees
that, promptly after the end of the fiscal year for
which the grant is made, the State will submit to the
Secretary a report that--
(A) describes the activities of the State
under the grant; and
(B) contains an evaluation of whether the
control programs of political subdivisions in
the State were effectively coordinated with
each other, which evaluation takes into account
any reports that the State received under
subsection (b)(5) from such subdivisions.
(5) Number of grants.--A State may not receive more
than one grant under paragraph (1).
(b) Prevention and Control Grants to Political
Subdivisions.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may make grants to political subdivisions
of States or consortia of political subdivisions of
States, for the operation of control programs.
(2) Preference in making grants.--In making grants
under paragraph (1), the Secretary shall give
preference to a political subdivision or consortium of
political subdivisions that--
(A) has--
(i) a history of elevated incidence
or prevalence of mosquito-borne
disease;
(ii) a population of infected
mosquitoes; or
(iii) met criteria determined by
the Secretary to suggest an increased
risk of elevated incidence or
prevalence of mosquito-borne disease in
the pending fiscal year;
(B) demonstrates to the Secretary that such
political subdivision or consortium of
political subdivisions will, if appropriate to
the mosquito circumstances involved,
effectively coordinate the activities of the
control programs with contiguous political
subdivisions;
(C) demonstrates to the Secretary (directly
or through State officials) that the State in
which such a political subdivision or
consortium of political subdivisions is located
has identified or will identify geographic
areas in such State that have a significant
need for control programs and will effectively
coordinate such programs in such areas; and
(D) is located in a State that has received
a grant under subsection (a).
(3) Requirement of assessment and plan.--A grant
may be made under paragraph (1) only if the political
subdivision or consortium of political subdivisions
involved--
(A) has conducted an assessment to
determine the immediate needs in such
subdivision or consortium for a control
program, including an entomological survey of
potential mosquito breeding areas; and
(B) has, on the basis of such assessment,
developed a plan for carrying out such a
program.
(4) Requirement of matching funds.--
(A) In general.--With respect to the costs
of a control program to be carried out under
paragraph (1) by a political subdivision or
consortium of political subdivisions, a grant
under such paragraph may be made only if the
subdivision or consortium agrees to make
available (directly or through donations from
public or private entities) non-Federal
contributions toward such costs in an amount
that is not less than \1/3\ of such costs ($1
for each $2 of Federal funds provided in the
grant).
(B) Determination of amount contributed.--
Non-Federal contributions required in
subparagraph (A) may be in cash or in kind,
fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of such non-Federal contributions.
(C) Waiver.--The Secretary may waive the
requirement established in subparagraph (A) if
the Secretary determines that extraordinary
economic conditions in the political
subdivision or consortium of political
subdivisions involved justify the waiver.
(5) Reports to secretary.--A grant may be made
under paragraph (1) only if the political subdivision
or consortium of political subdivisions involved agrees
that, promptly after the end of the fiscal year for
which the grant is made, the subdivision or consortium
will submit to the Secretary, and to the State within
which the subdivision or consortium is located, a
report that describes the control program and contains
an evaluation of whether the program was effective.
(6) Amount of grant; number of grants.--
(A) Amount of grant.--
(i) Single political subdivision.--
A grant under paragraph (1) awarded to
a political subdivision for a fiscal
year may not exceed $100,000.
(ii) Consortium.--A grant under
paragraph (1) awarded to a consortium
of 2 or more political subdivisions may
not exceed $110,000 for each political
subdivision. A consortium is not
required to provide matching funds
under paragraph (4) for any amounts
received by such consortium in excess
of amounts each political subdivision
would have received separately.
(iii) Waiver of requirement.--A
grant may exceed the maximum amount in
clause (i) or (ii) if the Secretary
determines that the geographical area
covered by a political subdivision or
consortium awarded a grant under
paragraph (1) has an extreme need due
to the size or density of--
(I) the human population in
such geographical area; or
(II) the mosquito
population in such geographical
area.
(B) Number of grants.--A political
subdivision or a consortium of political
subdivisions may not receive more than one
grant under paragraph (1).
(c) Applications for Grants.--A grant may be made under
subsection (a) or (b) only if an application for the grant is
submitted to the Secretary and the application is in such form,
is made in such manner, and contains such agreements,
assurances, and information as the Secretary determines to be
necessary to carry out this section.
(d) Technical Assistance.--Amounts appropriated under
subsection (f) may be used by the Secretary to provide training
and technical assistance with respect to the planning,
development, and operation of assessments and plans under
subsection (a) and control programs under subsection (b). The
Secretary may provide such technical assistance directly or
through awards of grants or contracts to public and private
entities.
(e) Definition of Political Subdivision.--In this section,
the term ``political subdivision'' means the local political
jurisdiction immediately below the level of State government,
including counties, parishes, and boroughs. If State law
recognizes an entity of general government that functions in
lieu of, and is not within, a county, parish, or borough, the
Secretary may recognize an area under the jurisdiction of such
other entities of general government as a political subdivision
for purposes of this section.
(f) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out
this section, there are authorized to be appropriated
$100,000,000 for fiscal year 2003, and such sums as may
be necessary for each of fiscal years 2004 through
2007.
(2) Public health emergencies.--In the case of
control programs carried out in response to a mosquito-
borne disease that constitutes a public health
emergency, the authorization of appropriations under
paragraph (1) is in addition to applicable
authorizations of appropriations under the Public
Health Security and Bioterrorism Preparedness and
Response Act of 2002.
(3) Fiscal year 2004 appropriations.--For fiscal
year 2004, 50 percent or more of the funds appropriated
under paragraph (1) shall be used to award grants to
political subdivisions or consortia of political
subdivisions under subsection (b).
SEC. 317T. [247B-22] MICROBICIDE RESEARCH.
(a) In General.--The Director of the Centers for Disease
Control and Prevention is strongly encouraged to fully
implement the Centers' microbicide agenda to support research
and development of microbicides for use to prevent the
transmission of the human immunodeficiency virus.
(b) Authorization of Appropriations.--There are authorized
to be appropriated such sums as may be necessary for each of
fiscal years 2009 through 2013 to carry out this section.
projects and programs for the prevention and control of sexually
transmitted diseases \1\
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\1\ Title II of Public Law 103-333, an appropriations Act, provides
(under the heading relating to the Centers for Disease Control and
Prevention; see 108 Stat. 2550) in part as follows: ``That funds
appropriated under this heading for fiscal year 1995 and subsequent
fiscal years shall be available for payment of the costs of medical
care, related expenses, and burial expenses hereafter incurred by or on
behalf of any person who had participated in the study of untreated
syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts and
subject to such terms and conditions as prescribed by the Secretary of
Health and Human Services and for payment, in such amounts and subject
to such terms and conditions, of such costs and expenses hereafter
incurred by or on behalf of such person's wife or offspring determined
by the Secretary to have suffered injury or disease from syphilis
contracted from such person''.
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Sec. 318. [247c] (a) The Secretary may provide technical
assistance to appropriate public and non-profit private
entities and to scientific institutions for their research in,
and training and public health programs for the prevention and
control of sexually transmitted diseases.
(b) The Secretary may make grants to States, political
subdivisions of States, and any other public and nonprofit
private entity for--
(1) research into the prevention and control of
sexually transmitted diseases;
(2) demonstration projects for the prevention and
control of sexually transmitted diseases;
(3) public information and education programs for
the prevention and control of such diseases; and
(4) education, training, and clinical skills
improvement activities in the prevention and control of
such diseases for health professionals (including
allied health personnel).
(c) The Secretary is also authorized to make project grants
to States and, in consultation with the State health authority,
to political subdivisions of States, for--
(1) sexually transmitted diseases surveillance
activities, including the reporting, screening, and
followup of diagnostic tests for, and diagnosed cases
of, sexually transmitted diseases;
(2) casefinding and case followup activities
respecting sexually transmitted diseases, including
contact tracing of infectious cases of sexually
transmitted diseases and routine testing, including
laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup
activities respecting sexually transmitted diseases;
and
(4) such special studies or demonstrations to
evaluate or test sexually transmitted diseases
prevention and control strategies and activities as may
be prescribed by the Secretary.
(d) The Secretary may make grants to States and political
subdivisions of States for the development, implementation, and
evaluation of innovative, interdisciplinary approaches to the
prevention and control of sexually transmitted diseases.
(e)(1) For the purpose of making grants under subsections
(b) through (d), there are authorized to be appropriated
$85,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep
such records as the Secretary shall prescribe including records
which fully disclose the amount and disposition by such
recipient of the proceeds of such grant, the total cost of the
project or undertaking in connection with which such grant was
given or used and the amount of that portion of the cost of the
project or undertaking supplied by other sources, and such
other records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall
have access for the purpose of audit and examination to any
books, documents, papers, and records of the recipients of
grants under this section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant
under this section, may reduce such grant by the fair market
value of any supplies or equipment furnished to such recipient
and by the amount of pay, allowances, travel expenses, and any
other costs in connection with the detail of an officer or
employee of the United States to the recipient when the
furnishing of such supplies or equipment or the detail of such
an officer or employee is for the convenience of and at the
request of such recipient and for the purpose of carrying out
the program with respect to which the grant under this section
is made. The amount by which any such grant is so reduced shall
be available for payment by the Secretary of the costs incurred
in furnishing the supplies, equipment, or personal services on
which the reduction of such grant is based.
(5) All information obtained in connection with the
examination, care, or treatment of any individual under any
program which is being carried out with a grant made under this
section shall not, without such individual's consent, be
disclosed except as may be necessary to provide service to him
or as may be required by a law of a State or political
subdivision of a State. Information derived from any such
program may be disclosed--
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or
provided care or treatment under such program is not disclosed.
(f) Nothing in this section shall be construed to require
any State or any political subdivision of a State to have a
sexually transmitted diseases program which would require any
person, who objects to any treatment provided under such a
program, to be treated under such a program.
INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
Sec. 318A. [247c-1] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may make grants to States, political subdivisions
of States, and other public or nonprofit private entities for
the purpose of carrying out the activities described in
subsection (c) regarding any treatable sexually transmitted
disease that can cause infertility in women if treatment is not
received for the disease.
(b) Authority Regarding Individual Diseases.--With respect
to diseases described in subsection (a), the Secretary shall,
in making a grant under such subsection, specify the particular
disease or diseases with respect to which the grant is to be
made. The Secretary may not make the grant unless the applicant
involved agrees to carry out this section only with respect to
the disease or diseases so specified.
(c) Authorized Activities.--With respect to any sexually
transmitted disease described in subsection (a), the activities
referred to in such subsection are--
(1) screening women for the disease and for
secondary conditions resulting from the disease,
subject to compliance with criteria issued under
subsection (f);
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention
and control of the disease (including, in the case of a
woman with the disease, counseling on the benefits of
locating and providing such counseling to any
individual from whom the woman may have contracted the
disease and any individual whom the woman may have
exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for
women screened pursuant to paragraph (1), including
referrals for evaluation and treatment with respect to
acquired immune deficiency syndrome and other sexually
transmitted diseases;
(6) in the case of any woman receiving services
pursuant to any of paragraphs (1) through (5),
providing to the partner of the woman the services
described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of
the availability of the services described in
paragraphs (1) through (6);
(8) providing to the public information and
education on the prevention and control of the disease,
including disseminating such information; and
(9) providing training to health care providers in
carrying out the screenings and counseling described in
paragraphs (1) and (3).
(d) Requirement of Availability of All Services Through
Each Grantee.--The Secretary may make a grant under subsection
(a) only if the applicant involved agrees that each activity
authorized in subsection (c) will be available through the
applicant. With respect to compliance with such agreement, the
applicant may expend the grant to carry out any of the
activities directly, and may expend the grant to enter into
agreements with other public or nonprofit private entities
under which the entities carry out the activities.
(e) Required Providers Regarding Certain Services.--The
Secretary may make a grant under subsection (a) only if the
applicant involved agrees that, in expending the grant to carry
out activities authorized in subsection (c), the services
described in paragraphs (1) through (7) of such subsection will
be provided only through entities that are State or local
health departments, grantees under section 329, 330, 340A, or
1001, or are other public or nonprofit private entities that
provide health services to a significant number of low-income
women.
(f) Quality Assurance Regarding Screening for Diseases.--
For purposes of this section, the Secretary shall establish
criteria for ensuring the quality of screening procedures for
diseases described in subsection (a).
(g) Confidentiality.--The Secretary may make a grant under
subsection (a) only if the applicant involved agrees, subject
to applicable law, to maintain the confidentiality of
information on individuals with respect to activities carried
out under subsection (c).
(h) Limitation on Imposition of Fees for Services.--The
Secretary may make a grant under subsection (a) only if the
applicant involved agrees that, if a charge is imposed for the
provision of services or activities under the grant, such
charge--
(1) will be made according to a schedule of charges
that is made available to the public;
(2) will be adjusted to reflect the income of the
individual involved; and
(3) will not be imposed on any individual with an
income of less than 150 percent of the official poverty
line, as established by the Director of the Office of
Management and Budget and revised by the Secretary in
accordance with section 673(2) of the Omnibus Budget
Reconciliation Act of 1981.
(i) Limitations on Certain Expenditures.--The Secretary may
make a grant under subsection (a) only if the applicant
involved agrees that not less than 80 percent of the grant will
be expended for the purpose of carrying out paragraphs (1)
through (7) of subsection (c).
(j) Reports to Secretary.--
(1) Collection of data.--The Secretary may make a
grant under subsection (a) only if the applicant
involved agrees, with respect to any disease selected
under subsection (b) for the applicant, to submit to
the Secretary, for each fiscal year for which the
applicant receives such a grant, a report providing--
(A) the incidence of the disease among the
population of individuals served by the
applicant;
(B) the number and demographic
characteristics of individuals in such
population;
(C) the types of interventions and
treatments provided by the applicant, and the
health conditions with respect to which
referrals have been made pursuant to subsection
(c)(5);
(D) an assessment of the extent to which
the activities carried pursuant to subsection
(a) have reduced the incidence of infertility
in the geographic area involved; and
(E) such other information as the Secretary
may require with respect to the project carried
out with the grant.
(2) Utility and comparability of data.--The
Secretary shall carry out activities for the purpose of
ensuring the utility and comparability of data
collected pursuant to paragraph (1).
(k) Maintenance of Effort.--With respect to activities for
which a grant under subsection (a) is authorized to be
expended, the Secretary may make such a grant only if the
applicant involved agrees to maintain expenditures of non-
Federal amounts for such activities at a level that is not less
than the average level of such expenditures maintained by the
applicant for the 2-year period preceding the fiscal year for
which the applicant is applying to receive such a grant.
(l) Requirement of Application.--
(1) In general.--The Secretary may make a grant
under subsection (a) only if an application for the
grant is submitted to the Secretary, the application
contains the plan required in paragraph (2), and the
application is in such form, is made in such manner,
and contains such agreements, assurances, and
information as the Secretary determines to be necessary
to carry out this section.
(2) Submission of plan for program of grantee.--
(A) In general.--The Secretary may make a
grant under subsection (a) only if the
applicant involved submits to the Secretary a
plan describing the manner in which the
applicant will comply with the agreements
required as a condition of receiving such a
grant, including a specification of the
entities through which activities authorized in
subsection (c) will be provided.
(B) Participation of certain entities.--The
Secretary may make a grant under subsection (a)
only if the applicant provides assurances
satisfactory to the Secretary that the plan
submitted under subparagraph (A) has been
prepared in consultation with an appropriate
number and variety of--
(i) representatives of entities in
the geographic area involved that
provide services for the prevention and
control of sexually transmitted
diseases, including programs to provide
to the public information and education
regarding such diseases; and
(ii) representatives of entities in
such area that provide family planning
services.
(m) Duration of Grant.--The period during which payments
are made to an entity from a grant under subsection (a) may not
exceed 3 years. The provision of such payments shall be subject
to annual approval by the Secretary of the payments and subject
to the availability of appropriations for the fiscal year
involved to make the payments in such year. The preceding
sentence may not be construed to establish a limitation on the
number of grants under such subsection that may be made to an
entity.
(n) Technical Assistance, and Supplies and Services in Lieu
of Grant Funds.--
(1) Technical assistance.--The Secretary may
provide training and technical assistance to grantees
under subsection (a) with respect to the planning,
development, and operation of any program or service
carried out under such subsection. The Secretary may
provide such technical assistance directly or through
grants or contracts.
(2) Supplies, equipment, and employee detail.--The
Secretary, at the request of a recipient of a grant
under subsection (a), may reduce the amount of such
grant by--
(A) the fair market value of any supplies
or equipment furnished the grant recipient; and
(B) the amount of the pay, allowances, and
travel expenses of any officer or employee of
the Government when detailed to the grant
recipient and the amount of any other costs
incurred in connection with the detail of such
officer or employee;
when the furnishing of such supplies or equipment or
the detail of such an officer or employee is for the
convenience of and at the request of such grant
recipient and for the purpose of carrying out a program
with respect to which the grant under subsection (a) is
made. The amount by which any such grant is so reduced
shall be available for payment by the Secretary of the
costs incurred in furnishing the supplies or equipment,
or in detailing the personnel, on which the reduction
of such grant is based, and such amount shall be deemed
as part of the grant and shall be deemed to have been
paid to the grant recipient.
(o) Evaluations and Reports by Secretary.--
(1) Evaluations.--The Secretary shall, directly or
through contracts with public or private entities,
provide for annual evaluations of programs carried out
pursuant to subsection (a) in order to determine the
quality and effectiveness of the programs.
(2) Report to congress.--Not later than 1 year
after the date on which amounts are first appropriated
pursuant to subsection (q), and biennially thereafter,
the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives, and to
the Committee on Labor and Human Resources of the
Senate, a report--
(A) summarizing the information provided to
the Secretary in reports made pursuant to
subsection (j)(1), including information on the
incidence of sexually transmitted diseases
described in subsection (a); and
(B) summarizing evaluations carried out
pursuant to paragraph (1) during the preceding
fiscal year.
(p) Coordination of Federal Programs.--The Secretary shall
coordinate the program carried out under this section with any
similar programs administered by the Secretary (including
coordination between the Director of the Centers for Disease
Control and Prevention and the Director of the National
Institutes of Health).
(q) Authorization of Appropriations.--For the purpose of
carrying out this section, other than subsections (o) and (r),
there are authorized to be appropriated $25,000,000 for fiscal
year 1993, and such sums as may be necessary for each of the
fiscal years 1994 through 1998.
(r) Separate Grants for Research on Delivery of
Services.--
(1) In general.--The Secretary may make grants for
the purpose of conducting research on the manner in
which the delivery of services under subsection (a) may
be improved. The Secretary may make such grants only to
grantees under such subsection and to public and
nonprofit private entities that are carrying out
programs substantially similar to programs carried out
under such subsection.
(2) Authorization of appropriations.--For the
purpose of carrying out paragraph (1), there are
authorized to be appropriated such sums as may be
necessary for each of the fiscal years 1993 through
1998.
data collection regarding programs under title xxvi
Sec. 318B. [247c-2] For the purpose of collecting and
providing data for program planning and evaluation activities
under title XXVI, there are authorized to be appropriated to
the Secretary (acting through the Director of the Centers for
Disease Control and Prevention) such sums as may be necessary
for each of the fiscal years 2001 through 2005. Such
authorization of appropriations is in addition to other
authorizations of appropriations that are available for such
purpose.
SEC. 319. [247D] PUBLIC HEALTH EMERGENCIES.
(a) Emergencies.--If the Secretary determines, after
consultation with such public health officials as may be
necessary, that--
(1) a disease or disorder presents a public health
emergency; or
(2) a public health emergency, including
significant outbreaks of infectious diseases or
bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to
respond to the public health emergency, including making
grants, providing awards for expenses, and entering into
contracts and conducting and supporting investigations into the
cause, treatment, or prevention of a disease or disorder as
described in paragraphs (1) and (2). Any such determination of
a public health emergency terminates upon the Secretary
declaring that the emergency no longer exists, or upon the
expiration of the 90-day period beginning on the date on which
the determination is made by the Secretary, whichever occurs
first. Determinations that terminate under the preceding
sentence may be renewed by the Secretary (on the basis of the
same or additional facts), and the preceding sentence applies
to each such renewal. Not later than 48 hours after making a
determination under this subsection of a public health
emergency (including a renewal), the Secretary shall submit to
the Congress written notification of the determination.
(b) Public Health Emergency Fund.--
(1) In general.--There is established in the
Treasury a fund to be designated as the ``Public Health
Emergency Fund'' to be made available to the Secretary
without fiscal year limitation to carry out subsection
(a) only if a public health emergency has been declared
by the Secretary under such subsection. There is
authorized to be appropriated to the Fund such sums as
may be necessary.
(2) Report.--Not later than 90 days after the end
of each fiscal year, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the
Senate and the Committee on Commerce and the Committee
on Appropriations of the House of Representatives a
report describing--
(A) the expenditures made from the Public
Health Emergency Fund in such fiscal year; and
(B) each public health emergency for which
the expenditures were made and the activities
undertaken with respect to each emergency which
was conducted or supported by expenditures from
the Fund.
(c) Supplement Not Supplant.--Funds appropriated under this
section shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities
under this section.
(d) Data Submittal and Reporting Deadlines.--In any case in
which the Secretary determines that, wholly or partially as a
result of a public health emergency that has been determined
pursuant to subsection (a), individuals or public or private
entities are unable to comply with deadlines for the submission
to the Secretary of data or reports required under any law
administered by the Secretary, the Secretary may,
notwithstanding any other provision of law, grant such
extensions of such deadlines as the circumstances reasonably
require, and may waive, wholly or partially, any sanctions
otherwise applicable to such failure to comply. Before or
promptly after granting such an extension or waiver, the
Secretary shall notify the Congress of such action and publish
in the Federal Register a notice of the extension or waiver.
SEC. 319A. [247D-1] VACCINE TRACKING AND DISTRIBUTION.
(a) Tracking.--The Secretary, together with relevant
manufacturers, wholesalers, and distributors as may agree to
cooperate, may track the initial distribution of federally
purchased influenza vaccine in an influenza pandemic. Such
tracking information shall be used to inform Federal, State,
local, and tribal decision makers during an influenza pandemic.
(b) Distribution.--The Secretary shall promote
communication between State, local, and tribal public health
officials and such manufacturers, wholesalers, and distributors
as agree to participate, regarding the effective distribution
of seasonal influenza vaccine. Such communication shall include
estimates of high priority populations, as determined by the
Secretary, in State, local, and tribal jurisdictions in order
to inform Federal, State, local, and tribal decision makers
during vaccine shortages and supply disruptions.
(c) Confidentiality.--The information submitted to the
Secretary or its contractors, if any, under this section or
under any other section of this Act related to vaccine
distribution information shall remain confidential in
accordance with the exception from the public disclosure of
trade secrets, commercial or financial information, and
information obtained from an individual that is privileged and
confidential, as provided for in section 552(b)(4) of title 5,
United States Code, and subject to the penalties and exceptions
under sections 1832 and 1833 of title 18, United States Code,
relating to the protection and theft of trade secrets, and
subject to privacy protections that are consistent with the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996. None of
such information provided by a manufacturer, wholesaler, or
distributor shall be disclosed without its consent to another
manufacturer, wholesaler, or distributor, or shall be used in
any manner to give a manufacturer, wholesaler, or distributor a
proprietary advantage.
(d) Guidelines.--The Secretary, in order to maintain the
confidentiality of relevant information and ensure that none of
the information contained in the systems involved may be used
to provide proprietary advantage within the vaccine market,
while allowing State, local, and tribal health officials access
to such information to maximize the delivery and availability
of vaccines to high priority populations, during times of
influenza pandemics, vaccine shortages, and supply disruptions,
in consultation with manufacturers, distributors, wholesalers
and State, local, and tribal health departments, shall develop
guidelines for subsections (a) and (b).
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, such sums for
each of fiscal years 2007 through 2011.
(f) Report to Congress.--As part of the National Health
Security Strategy described in section 2802, the Secretary
shall provide an update on the implementation of subsections
(a) through (d).
SEC. 319C-1. [247D-3A] IMPROVING STATE AND LOCAL PUBLIC HEALTH
SECURITY. \1\
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\1\ Former sections 319B and 319C were repealed by section
204(b)(1) of Public Law 109-417 (120 Stat. 2951).
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(a) In General.--To enhance the security of the United
States with respect to public health emergencies, the Secretary
shall award cooperative agreements to eligible entities to
enable such entities to conduct the activities described in
subsection (d).
(b) Eligible Entities.--To be eligible to receive an award
under subsection (a), an entity shall--
(1)(A) be a State;
(B) be a political subdivision determined by the
Secretary to be eligible for an award under this
section (based on criteria described in subsection
(i)(4)); or
(C) be a consortium of entities described in
subparagraph (A); and
(2) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require, including--
(A) an All-Hazards Public Health Emergency
Preparedness and Response Plan which shall
include--
(i) a description of the activities
such entity will carry out under the
agreement to meet the goals identified
under section 2802;
(ii) a pandemic influenza plan
consistent with the requirements of
paragraphs (2) and (5) of subsection
(g);
(iii) preparedness and response
strategies and capabilities that take
into account the medical and public
health needs of at-risk individuals in
the event of a public health emergency;
(iv) a description of the mechanism
the entity will implement to utilize
the Emergency Management Assistance
Compact or other mutual aid agreements
for medical and public health mutual
aid; and
(v) a description of how the entity
will include the State Unit on Aging in
public health emergency preparedness;
(B) an assurance that the entity will
report to the Secretary on an annual basis (or
more frequently as determined by the Secretary)
on the evidence-based benchmarks and objective
standards established by the Secretary to
evaluate the preparedness and response
capabilities of such entity under subsection
(g);
(C) an assurance that the entity will
conduct, on at least an annual basis, an
exercise or drill that meets any criteria
established by the Secretary to test the
preparedness and response capabilities of such
entity, and that the entity will report back to
the Secretary within the application of the
following year on the strengths and weaknesses
identified through such exercise or drill, and
corrective actions taken to address material
weaknesses;
(D) an assurance that the entity will
provide to the Secretary the data described
under section 319D(d)(3) as determined feasible
by the Secretary;
(E) an assurance that the entity will
conduct activities to inform and educate the
hospitals within the jurisdiction of such
entity on the role of such hospitals in the
plan required under subparagraph (A);
(F) an assurance that the entity, with
respect to the plan described under
subparagraph (A), has developed and will
implement an accountability system to ensure
that such entity make satisfactory annual
improvement and describe such system in the
plan under subparagraph (A);
(G) a description of the means by which to
obtain public comment and input on the plan
described in subparagraph (A) and on the
implementation of such plan, that shall include
an advisory committee or other similar
mechanism for obtaining comment from the public
and from other State, local, and tribal
stakeholders; and
(H) as relevant, a description of the
process used by the entity to consult with
local departments of public health to reach
consensus, approval, or concurrence on the
relative distribution of amounts received under
this section.
(c) Limitation.--Beginning in fiscal year 2009, the
Secretary may not award a cooperative agreement to a State
unless such State is a participant in the Emergency System for
Advance Registration of Volunteer Health Professionals
described in section 319I.
(d) Use of Funds.--
(1) In general.--An award under subsection (a)
shall be expended for activities to achieve the
preparedness goals described under paragraphs (1), (2),
(4), (5), and (6) of section 2802(b).
(2) Effect of section.--Nothing in this subsection
may be construed as establishing new regulatory
authority or as modifying any existing regulatory
authority.
(e) Coordination With Local Response Capabilities.--An
entity shall, to the extent practicable, ensure that activities
carried out under an award under subsection (a) are coordinated
with activities of relevant Metropolitan Medical Response
Systems, local public health departments, the Cities Readiness
Initiative, and local emergency plans.
(f) Consultation With Homeland Security.--In making awards
under subsection (a), the Secretary shall consult with the
Secretary of Homeland Security to--
(1) ensure maximum coordination of public health
and medical preparedness and response activities with
the Metropolitan Medical Response System, and other
relevant activities;
(2) minimize duplicative funding of programs and
activities;
(3) analyze activities, including exercises and
drills, conducted under this section to develop
recommendations and guidance on best practices for such
activities; and
(4) disseminate such recommendations and guidance,
including through expanding existing lessons learned
information systems to create a single Internet-based
point of access for sharing and distributing medical
and public health best practices and lessons learned
from drills, exercises, disasters, and other
emergencies.
(g) Achievement of Measurable Evidence-Based Benchmarks and
Objective Standards.--
(1) In general.--Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall develop or where
appropriate adopt, and require the application of,
measurable evidence-based benchmarks and objective
standards that measure levels of preparedness with
respect to the activities described in this section and
with respect to activities described in section 319C-2.
In developing such benchmarks and standards, the
Secretary shall consult with and seek comments from
State, local, and tribal officials and private
entities, as appropriate. Where appropriate, the
Secretary shall incorporate existing objective
standards. Such benchmarks and standards shall--
(A) include outcome goals representing
operational achievement of the National
Preparedness Goals developed under section
2802(b); and
(B) at a minimum, require entities to--
(i) measure progress toward
achieving the outcome goals; and
(ii) at least annually, test,
exercise, and rigorously evaluate the
public health and medical emergency
preparedness and response capabilities
of the entity, and report to the
Secretary on such measured and tested
capabilities and measured and tested
progress toward achieving outcome
goals, based on criteria established by
the Secretary.
(2) Criteria for pandemic influenza plans.--
(A) In general.--Not later than 180 days
after the date of enactment of the Pandemic and
All-Hazards Preparedness Act, the Secretary
shall develop and disseminate to the chief
executive officer of each State criteria for an
effective State plan for responding to pandemic
influenza.
(B) Rule of construction.--Nothing in this
section shall be construed to require the
duplication of Federal efforts with respect to
the development of criteria or standards,
without regard to whether such efforts were
carried out prior to or after the date of
enactment of this section.
(3) Technical assistance.--The Secretary shall, as
determined appropriate by the Secretary, provide to a
State, upon request, technical assistance in meeting
the requirements of this section, including the
provision of advice by experts in the development of
high-quality assessments, the setting of State
objectives and assessment methods, the development of
measures of satisfactory annual improvement that are
valid and reliable, and other relevant areas.
(4) Notification of failures.--The Secretary shall
develop and implement a process to notify entities that
are determined by the Secretary to have failed to meet
the requirements of paragraph (1) or (2). Such process
shall provide such entities with the opportunity to
correct such noncompliance. An entity that fails to
correct such noncompliance shall be subject to
paragraph (5).
(5) Withholding of amounts from entities that fail
to achieve benchmarks or submit influenza plan.--
Beginning with fiscal year 2009, and in each succeeding
fiscal year, the Secretary shall--
(A) withhold from each entity that has
failed substantially to meet the benchmarks and
performance measures described in paragraph (1)
for the immediately preceding fiscal year
(beginning with fiscal year 2008), pursuant to
the process developed under paragraph (4), the
amount described in paragraph (6); and
(B) withhold from each entity that has
failed to submit to the Secretary a plan for
responding to pandemic influenza that meets the
criteria developed under paragraph (2), the
amount described in paragraph (6).
(6) Amounts described.--
(A) In general.--The amounts described in
this paragraph are the following amounts that
are payable to an entity for activities
described in section 319C-1 or 319C-2:
(i) For the fiscal year immediately
following a fiscal year in which an
entity experienced a failure described
in subparagraph (A) or (B) of paragraph
(5) by the entity, an amount equal to
10 percent of the amount the entity was
eligible to receive for such fiscal
year.
(ii) For the fiscal year
immediately following two consecutive
fiscal years in which an entity
experienced such a failure, an amount
equal to 15 percent of the amount the
entity was eligible to receive for such
fiscal year, taking into account the
withholding of funds for the
immediately preceding fiscal year under
clause (i).
(iii) For the fiscal year
immediately following three consecutive
fiscal years in which an entity
experienced such a failure, an amount
equal to 20 percent of the amount the
entity was eligible to receive for such
fiscal year, taking into account the
withholding of funds for the
immediately preceding fiscal years
under clauses (i) and (ii).
(iv) For the fiscal year
immediately following four consecutive
fiscal years in which an entity
experienced such a failure, an amount
equal to 25 percent of the amount the
entity was eligible to receive for such
a fiscal year, taking into account the
withholding of funds for the
immediately preceding fiscal years
under clauses (i), (ii), and (iii).
(B) Separate accounting.--Each failure
described in subparagraph (A) or (B) of
paragraph (5) shall be treated as a separate
failure for purposes of calculating amounts
withheld under subparagraph (A).
(7) Reallocation of amounts withheld.--
(A) In general.--The Secretary shall make
amounts withheld under paragraph (6) available
for making awards under section 319C-2 to
entities described in subsection (b)(1) of such
section.
(B) Preference in reallocation.--In making
awards under section 319C-2 with amounts
described in subparagraph (A), the Secretary
shall give preference to eligible entities (as
described in section 319C-2(b)(1)) that are
located in whole or in part in States from
which amounts have been withheld under
paragraph (6).
(8) Waive or reduce withholding.--The Secretary may
waive or reduce the withholding described in paragraph
(6), for a single entity or for all entities in a
fiscal year, if the Secretary determines that
mitigating conditions exist that justify the waiver or
reduction.
(h) Grants for Real-Time Disease Detection Improvement.--
(1) In general.--The Secretary may award grants to
eligible entities to carry out projects described under
paragraph (4).
(2) Eligible entity.--For purposes of this section,
the term ``eligible entity'' means an entity that is--
(A)(i) a hospital, clinical laboratory,
university; or
(ii) a poison control center or
professional organization in the field of
poison control; and
(B) a participant in the network
established under subsection 319D(d).
(3) Application.--Each eligible entity desiring a
grant under this subsection shall submit to the
Secretary an application at such time, in such manner,
and containing such information as the Secretary may
require.
(4) Use of funds.--
(A) In general.--An eligible entity
described in paragraph (2)(A)(i) that receives
a grant under this subsection shall use the
funds awarded pursuant to such grant to carry
out a pilot demonstration project to purchase
and implement the use of advanced diagnostic
medical equipment to analyze real-time clinical
specimens for pathogens of public health or
bioterrorism significance and report any
results from such project to State, local, and
tribal public health entities and the network
established under section 319D(d).
(B) Other entities.--An eligible entity
described in paragraph (2)(A)(ii) that receives
a grant under this section shall use the funds
awarded pursuant to such grant to--
(i) improve the early detection,
surveillance, and investigative
capabilities of poison control centers
for chemical, biological, radiological,
and nuclear events by training poison
information personnel to improve the
accuracy of surveillance data,
improving the definitions used by the
poison control centers for
surveillance, and enhancing timely and
efficient investigation of data
anomalies;
(ii) improve the capabilities of
poison control centers to provide
information to health care providers
and the public with regard to chemical,
biological, radiological, or nuclear
threats or exposures, in consultation
with the appropriate State, local, and
tribal public health entities; or
(iii) provide surge capacity in the
event of a chemical, biological,
radiological, or nuclear event through
the establishment of alternative poison
control center worksites and the
training of nontraditional personnel.
(i) Funding.--
(1) Authorization of appropriations.--
(A) In general.--For the purpose of
carrying out this section, there is authorized
to be appropriated $824,000,000 for fiscal year
2007, of which $35,000,000 shall be used to
carry out subsection (h), for awards pursuant
to paragraph (3) (subject to the authority of
the Secretary to make awards pursuant to
paragraphs (4) and (5)), and such sums as may
be necessary for each of fiscal years 2008
through 2011.
(B) Coordination.--There are authorized to
be appropriated, $10,000,000 for fiscal year
2007 to carry out subsection (f)(4) of this
section and section 2814.
(C) Requirement for state matching funds.--
Beginning in fiscal year 2009, in the case of
any State or consortium of two or more States,
the Secretary may not award a cooperative
agreement under this section unless the State
or consortium of States agree that, with
respect to the amount of the cooperative
agreement awarded by the Secretary, the State
or consortium of States will make available
(directly or through donations from public or
private entities) non-Federal contributions in
an amount equal to--
(i) for the first fiscal year of
the cooperative agreement, not less
than 5 percent of such costs ($1 for
each $20 of Federal funds provided in
the cooperative agreement); and
(ii) for any second fiscal year of
the cooperative agreement, and for any
subsequent fiscal year of such
cooperative agreement, not less than 10
percent of such costs ($1 for each $10
of Federal funds provided in the
cooperative agreement).
(D) Determination of amount of non-federal
contributions.--As determined by the Secretary,
non-Federal contributions required in
subparagraph (C) may be provided directly or
through donations from public or private
entities and may be in cash or in kind, fairly
evaluated, including plant, equipment or
services. Amounts provided by the Federal
government, or services assisted or subsidized
to any significant extent by the Federal
government, may not be included in determining
the amount of such non-Federal contributions.
(2) Maintaining state funding.--
(A) In general.--An entity that receives an
award under this section shall maintain
expenditures for public health security at a
level that is not less than the average level
of such expenditures maintained by the entity
for the preceding 2 year period.
(B) Rule of construction.--Nothing in this
section shall be construed to prohibit the use
of awards under this section to pay salary and
related expenses of public health and other
professionals employed by State, local, or
tribal public health agencies who are carrying
out activities supported by such awards
(regardless of whether the primary assignment
of such personnel is to carry out such
activities).
(3) Determination of amount.--
(A) In general.--The Secretary shall award
cooperative agreements under subsection (a) to
each State or consortium of 2 or more States
that submits to the Secretary an application
that meets the criteria of the Secretary for
the receipt of such an award and that meets
other implementation conditions established by
the Secretary for such awards
(B) Base amount.--In determining the amount
of an award pursuant to subparagraph (A) for a
State, the Secretary shall first determine an
amount the Secretary considers appropriate for
the State (referred to in this paragraph as the
``base amount''), except that such amount may
not be greater than the minimum amount
determined under subparagraph (D).
(C) Increase on basis of population.--After
determining the base amount for a State under
subparagraph (B), the Secretary shall increase
the base amount by an amount equal to the
product of--
(i) the amount appropriated under
paragraph (1)(A)(i)(I) for the fiscal
year, less an amount equal to the sum
of all base amounts determined for the
States under subparagraph (B), and less
the amount, if any, reserved by the
Secretary under paragraphs (4) and (5);
and
(ii) subject to paragraph (4)(C),
the percentage constituted by the ratio
of an amount equal to the population of
the State over an amount equal to the
total population of the States (as
indicated by the most recent data
collected by the Bureau of the Census).
(D) Minimum amount.--Subject to the amount
appropriated under paragraph (1)(A)(i)(I), an
award pursuant to subparagraph (A) for a State
shall be the greater of the base amount as
increased under subparagraph (C), or the
minimum amount under this subparagraph. The
minimum amount under this subparagraph is--
(i) in the case of each of the
several States, the District of
Columbia, and the Commonwealth of
Puerto Rico, an amount equal to the
lesser of--
(I) $5,000,000; or
(II) if the amount
appropriated under paragraph
(1)(A)(i)(I) is less than
$667,000,000, an amount equal
to 0.75 percent of the amount
appropriated under such
paragraph, less the amount, if
any, reserved by the Secretary
under paragraphs (4) and (5);
or
(ii) in the case of each of
American Samoa, Guam, the Commonwealth
of the Northern Mariana Islands, and
the Virgin Islands, an amount
determined by the Secretary to be
appropriate, except that such amount
may not exceed the amount determined
under clause (i).
(4) Certain political subdivisions.--
(A) In general.--For fiscal year 2007, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the
amount appropriated under paragraph (1) for the
year an amount determined necessary by the
Secretary to make awards under subsection (a)
to political subdivisions that have a
substantial number of residents, have a
substantial local infrastructure for responding
to public health emergencies, and face a high
degree of risk from bioterrorist attacks or
other public health emergencies. Not more than
three political subdivisions may receive awards
pursuant to this subparagraph.
(B) Coordination with statewide plans.--An
award pursuant to subparagraph (A) may not be
made unless the application of the political
subdivision involved is in coordination with,
and consistent with, applicable Statewide plans
described in subsection (c).
(C) Relationship to formula grants.--In the
case of a State that will receive an award
pursuant to paragraph (3), and in which there
is located a political subdivision that will
receive an award pursuant to subparagraph (A),
the Secretary shall, in determining the amount
under paragraph (3)(C) for the State, subtract
from the population of the State an amount
equal to the population of such political
subdivision.
(D) Continuity of funding.--In determining
whether to make an award pursuant to
subparagraph (A) to a political subdivision,
the Secretary may consider, as a factor
indicating that the award should be made, that
the political subdivision received public
health funding from the Secretary for fiscal
year 2006.
(5) Significant unmet needs; degree of risk.--
(A) In general.--For fiscal year 2007, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the
amount appropriated under paragraph (1) for the
year an amount determined necessary by the
Secretary to make awards under subsection (a)
to eligible entities that--
(i) have a significant need for
funds to build capacity to identify,
detect, monitor, and respond to a
bioterrorist or other threat to the
public health, which need will not be
met by awards pursuant to paragraph
(3); and
(ii) face a particularly high
degree of risk of such a threat.
(B) Recipients of grants.--Awards pursuant
to subparagraph (A) may be supplemental awards
to States that receive awards pursuant to
paragraph (3), or may be awards to eligible
entities described in subsection (b)(1)(B)
within such States.
(C) Finding with respect to district of
columbia.--The Secretary shall consider the
District of Columbia to have a significant
unmet need for purposes of subparagraph (A),
and to face a particularly high degree of risk
for such purposes, on the basis of the
concentration of entities of national
significance located within the District.
(6) Funding of local entities.--The Secretary
shall, in making awards under this section, ensure that
with respect to the cooperative agreement awarded, the
entity make available appropriate portions of such
award to political subdivisions and local departments
of public health through a process involving the
consensus, approval or concurrence with such local
entities.
(j) Administrative and Fiscal Responsibility.--
(1) Annual reporting requirements.--Each entity
shall prepare and submit to the Secretary annual
reports on its activities under this section and
section 319C-2. Each such report shall be prepared by,
or in consultation with, the health department. In
order to properly evaluate and compare the performance
of different entities assisted under this section and
section 319C-2 and to assure the proper expenditure of
funds under this section and section 319C-2, such
reports shall be in such standardized form and contain
such information as the Secretary determines and
describes within 180 days of the date of enactment of
the Pandemic and All-Hazards Preparedness Act (after
consultation with the States) to be necessary to--
(A) secure an accurate description of those
activities;
(B) secure a complete record of the
purposes for which funds were spent, and of the
recipients of such funds;
(C) describe the extent to which the entity
has met the goals and objectives it set forth
under this section or section 319C-2;
(D) determine the extent to which funds
were expended consistent with the entity's
application transmitted under this section or
section 319C-2; and
(E) publish such information on a Federal
Internet website consistent with subsection
(k).
(2) Audits; implementation.--
(A) In general.--Each entity receiving
funds under this section or section 319C-2
shall, not less often than once every 2 years,
audit its expenditures from amounts received
under this section or section 319C-2. Such
audits shall be conducted by an entity
independent of the agency administering a
program funded under this section or section
319C-2 in accordance with the Comptroller
General's standards for auditing governmental
organizations, programs, activities, and
functions and generally accepted auditing
standards. Within 30 days following the
completion of each audit report, the entity
shall submit a copy of that audit report to the
Secretary.
(B) Repayment.--Each entity shall repay to
the United States amounts found by the
Secretary, after notice and opportunity for a
hearing to the entity, not to have been
expended in accordance with this section or
section 319C-2 and, if such repayment is not
made, the Secretary may offset such amounts
against the amount of any allotment to which
the entity is or may become entitled under this
section or section 319C-2 or may otherwise
recover such amounts.
(C) Withholding of payment.--The Secretary
may, after notice and opportunity for a
hearing, withhold payment of funds to any
entity which is not using its allotment under
this section or section 319C-2 in accordance
with such section. The Secretary may withhold
such funds until the Secretary finds that the
reason for the withholding has been removed and
there is reasonable assurance that it will not
recur.
(3) Maximum carryover amount.--
(A) In general.--For each fiscal year, the
Secretary, in consultation with the States and
political subdivisions, shall determine the
maximum percentage amount of an award under
this section that an entity may carryover to
the succeeding fiscal year.
(B) Amount exceeded.--For each fiscal year,
if the percentage amount of an award under this
section unexpended by an entity exceeds the
maximum percentage permitted by the Secretary
under subparagraph (A), the entity shall return
to the Secretary the portion of the unexpended
amount that exceeds the maximum amount
permitted to be carried over by the Secretary.
(C) Action by secretary.--The Secretary
shall make amounts returned to the Secretary
under subparagraph (B) available for awards
under section 319C-2(b)(1). In making awards
under section 319C-2(b)(1) with amounts
collected under this paragraph the Secretary
shall give preference to entities that are
located in whole or in part in States from
which amounts have been returned under
subparagraph (B).
(D) Waiver.--An entity may apply to the
Secretary for a waiver of the maximum
percentage amount under subparagraph (A). Such
an application for a waiver shall include an
explanation why such requirement should not
apply to the entity and the steps taken by such
entity to ensure that all funds under an award
under this section will be expended
appropriately.
(E) Waive or reduce withholding.--The
Secretary may waive the application of
subparagraph (B), or reduce the amount
determined under such subparagraph, for a
single entity pursuant to subparagraph (D) or
for all entities in a fiscal year, if the
Secretary determines that mitigating conditions
exist that justify the waiver or reduction.
(k) Compilation and Availability of Data.--The Secretary
shall compile the data submitted under this section and make
such data available in a timely manner on an appropriate
Internet website in a format that is useful to the public and
to other entities and that provides information on what
activities are best contributing to the achievement of the
outcome goals described in subsection (g).
SEC. 319C-2. [247D-3B] PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL
PREPAREDNESS TO IMPROVE SURGE CAPACITY.
(a) In General.--The Secretary shall award competitive
grants or cooperative agreements to eligible entities to enable
such entities to improve surge capacity and enhance community
and hospital preparedness for public health emergencies.
(b) Eligibility.--To be eligible for an award under
subsection (a), an entity shall--
(1)(A) be a partnership consisting of--
(i) one or more hospitals, at least one of
which shall be a designated trauma center,
consistent with section 1213(c);
(ii) one or more other local health care
facilities, including clinics, health centers,
primary care facilities, mental health centers,
mobile medical assets, or nursing homes; and
(iii)(I) one or more political
subdivisions;
(II) one or more States; or
(III) one or more States and one or more
political subdivisions; and
(B) prepare, in consultation with the Chief
Executive Officer and the lead health officials of the
State, District, or territory in which the hospital and
health care facilities described in subparagraph (A)
are located, and submit to the Secretary, an
application at such time, in such manner, and
containing such information as the Secretary may
require; or
(2)(A) be an entity described in section 319C-
1(b)(1); and
(B) submit an application at such time, in such
manner, and containing such information as the
Secretary may require, including the information or
assurances required under section 319C-1(b)(2) and an
assurance that the State will adhere to any applicable
guidelines established by the Secretary.
(c) Use of Funds.--An award under subsection (a) shall be
expended for activities to achieve the preparedness goals
described under paragraphs (1), (3), (4), (5), and (6) of
section 2802(b).
(d) Preferences.--
(1) Regional coordination.--In making awards under
subsection (a), the Secretary shall give preference to
eligible entities that submit applications that, in the
determination of the Secretary--
(A) will enhance coordination--
(i) among the entities described in
subsection (b)(1)(A)(i); and
(ii) between such entities and the
entities described in subsection
(b)(1)(A)(ii); and
(B) include, in the partnership described
in subsection (b)(1)(A), a significant
percentage of the hospitals and health care
facilities within the geographic area served by
such partnership.
(2) Other preferences.--In making awards under
subsection (a), the Secretary shall give preference to
eligible entities that, in the determination of the
Secretary--
(A) include one or more hospitals that are
participants in the National Disaster Medical
System;
(B) are located in a geographic area that
faces a high degree of risk, as determined by
the Secretary in consultation with the
Secretary of Homeland Security; or
(C) have a significant need for funds to
achieve the medical preparedness goals
described in section 2802(b)(3).
(e) Consistency of Planned Activities.--The Secretary may
not award a cooperative agreement to an eligible entity
described in subsection (b)(1) unless the application submitted
by the entity is coordinated and consistent with an applicable
State All-Hazards Public Health Emergency Preparedness and
Response Plan and relevant local plans, as determined by the
Secretary in consultation with relevant State health officials.
(f) Limitation on Awards.--A political subdivision shall
not participate in more than one partnership described in
subsection (b)(1).
(g) Coordination With Local Response Capabilities.--An
eligible entity shall, to the extent practicable, ensure that
activities carried out under an award under subsection (a) are
coordinated with activities of relevant local Metropolitan
Medical Response Systems, local Medical Reserve Corps, the
Cities Readiness Initiative, and local emergency plans.
(h) Maintenance of Funding.--
(1) In general.--An entity that receives an award
under this section shall maintain expenditures for
health care preparedness at a level that is not less
than the average level of such expenditures maintained
by the entity for the preceding 2 year period.
(2) Rule of construction.--Nothing in this section
shall be construed to prohibit the use of awards under
this section to pay salary and related expenses of
public health and other professionals employed by
State, local, or tribal agencies who are carrying out
activities supported by such awards (regardless of
whether the primary assignment of such personnel is to
carry out such activities).
(i) Performance and Accountability.--The requirements of
section 319C-1(g), (j), and (k) shall apply to entities
receiving awards under this section (regardless of whether such
entities are described under subsection (b)(1)(A) or (b)(2)(A))
in the same manner as such requirements apply to entities under
section 319C-1. An entity described in subsection (b)(1)(A)
shall make such reports available to the lead health official
of the State in which such partnership is located.
(j) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out
this section, there is authorized to be appropriated
$474,000,000 for fiscal year 2007, and such sums as may
be necessary for each of fiscal years 2008 through
2011.
(2) Reservation of amounts for partnerships.--Prior
to making awards described in paragraph (3), the
Secretary may reserve from the amount appropriated
under paragraph (1) for a fiscal year, an amount
determined appropriate by the Secretary for making
awards to entities described in subsection (b)(1)(A).
(3) Awards to states and political subdivisions.--
(A) In general.--From amounts appropriated
for a fiscal year under paragraph (1) and not
reserved under paragraph (2), the Secretary
shall make awards to entities described in
subsection (b)(2)(A) that have completed an
application as described in subsection
(b)(2)(B).
(B) Amount.--The Secretary shall determine
the amount of an award to each entity described
in subparagraph (A) in the same manner as such
amounts are determined under section 319C-1(i).
SEC. 319D. [247D-4] REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
(a) Facilities; Capacities.--
(1) Findings.--Congress finds that the Centers for
Disease Control and Prevention has an essential role in
defending against and combatting public health threats
domestically and abroad and requires secure and modern
facilities, and expanded and improved capabilities
related to bioterrorism and other public health
emergencies, sufficient to enable such Centers to
conduct this important mission.
(2) Facilities.--
(A) In general.--The Director of the
Centers for Disease Control and Prevention may
design, construct, and equip new facilities,
renovate existing facilities (including
laboratories, laboratory support buildings,
scientific communication facilities,
transshipment complexes, secured and isolated
parking structures, office buildings, and other
facilities and infrastructure), and upgrade
security of such facilities, in order to better
conduct the capacities described in section
319A, and for supporting public health
activities.
(B) Multiyear contracting authority.--For
any project of designing, constructing,
equipping, or renovating any facility under
subparagraph (A), the Director of the Centers
for Disease Control and Prevention may enter
into a single contract or related contracts
that collectively include the full scope of the
project, and the solicitation and contract
shall contain the clause ``availability of
funds'' found at section 52.232-18 of title 48,
Code of Federal Regulations.
(3) Improving the capacities of the centers for
disease control and prevention.--The Secretary shall
expand, enhance, and improve the capabilities of the
Centers for Disease Control and Prevention relating to
preparedness for and responding effectively to
bioterrorism and other public health emergencies.
Activities that may be carried out under the preceding
sentence include--
(A) expanding or enhancing the training of
personnel;
(B) improving communications facilities and
networks, including delivery of necessary
information to rural areas;
(C) improving capabilities for public
health surveillance and reporting activities,
taking into account the integrated system or
systems of public health alert communications
and surveillance networks under subsection (b);
and
(D) improving laboratory facilities related
to bioterrorism and other public health
emergencies, including increasing the security
of such facilities.
(b) National Communications and Surveillance Networks.--
(1) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements,
shall provide for the establishment of an integrated
system or systems of public health alert communications
and surveillance networks between and among--
(A) Federal, State, and local public health
officials;
(B) public and private health-related
laboratories, hospitals, and other health care
facilities; and
(C) any other entities determined
appropriate by the Secretary.
(2) Requirements.--The Secretary shall ensure that
networks under paragraph (1) allow for the timely
sharing and discussion, in a secure manner, of
essential information concerning bioterrorism or
another public health emergency, or recommended methods
for responding to such an attack or emergency.
(3) Standards.--Not later than one year after the
date of the enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, the
Secretary, in cooperation with health care providers
and State and local public health officials, shall
establish any additional technical and reporting
standards (including standards for interoperability)
for networks under paragraph (1).
(c) Authorization of Appropriations.--
(1) Facilities; capacities.--
(A) Facilities.--For the purpose of
carrying out subsection (a)(2), there are
authorized to be appropriated $300,000,000 for
each of the fiscal years 2002 and 2003, and
such sums as may be necessary for each of the
fiscal years 2004 through 2006.
(B) Mission; Improving capacities.--For the
purposes of achieving the mission of the
Centers for Disease Control and Prevention
described in subsection (a)(1), for carrying
out subsection (a)(3), for better conducting
the capacities described in section 319A, and
for supporting public health activities, there
are authorized to be appropriated such sums as
may be necessary for each of the fiscal years
2002 through 2006.
(2) National communications and surveillance
networks.--For the purpose of carrying out subsection
(b), there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2002
through 2006.
(d) Public Health Situational Awareness.--
(1) In general.--Not later than 2 years after the
date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary, in collaboration with
State, local, and tribal public health officials, shall
establish a near real-time electronic nationwide public
health situational awareness capability through an
interoperable network of systems to share data and
information to enhance early detection of rapid
response to, and management of, potentially
catastrophic infectious disease outbreaks and other
public health emergencies that originate domestically
or abroad. Such network shall be built on existing
State situational awareness systems or enhanced systems
that enable such connectivity.
(2) Strategic plan.--Not later than 180 days after
the date of enactment the Pandemic and All-Hazards
Preparedness Act, the Secretary shall submit to the
appropriate committees of Congress, a strategic plan
that demonstrates the steps the Secretary will
undertake to develop, implement, and evaluate the
network described in paragraph (1), utilizing the
elements described in paragraph (3).
(3) Elements.--The network described in paragraph
(1) shall include data and information transmitted in a
standardized format from--
(A) State, local, and tribal public health
entities, including public health laboratories;
(B) Federal health agencies;
(C) zoonotic disease monitoring systems;
(D) public and private sector health care
entities, hospitals, pharmacies, poison control
centers or professional organizations in the
field of poison control, and clinical
laboratories, to the extent practicable and
provided that such data are voluntarily
provided simultaneously to the Secretary and
appropriate State, local, and tribal public
health agencies; and
(E) such other sources as the Secretary may
deem appropriate.
(4) Rule of construction.--Paragraph (3) shall not
be construed as requiring separate reporting of data
and information from each source listed.
(5) Required activities.--In establishing and
operating the network described in paragraph (1), the
Secretary shall--
(A) utilize applicable interoperability
standards as determined by the Secretary
through a joint public and private sector
process;
(B) define minimal data elements for such
network;
(C) in collaboration with State, local, and
tribal public health officials, integrate and
build upon existing State, local, and tribal
capabilities, ensuring simultaneous sharing of
data, information, and analyses from the
network described in paragraph (1) with State,
local, and tribal public health agencies; and
(D) in collaboration with State, local, and
tribal public health officials, develop
procedures and standards for the collection,
analysis, and interpretation of data that
States, regions, or other entities collect and
report to the network described in paragraph
(1).
(e) State and Regional Systems To Enhance Situational
Awareness in Public Health Emergencies.--
(1) In general.--To implement the network described
in subsection (d), the Secretary may award grants to
States or consortia of States to enhance the ability of
such States or consortia of States to establish or
operate a coordinated public health situational
awareness system for regional or Statewide early
detection of, rapid response to, and management of
potentially catastrophic infectious disease outbreaks
and public health emergencies, in collaboration with
appropriate public health agencies, sentinel hospitals,
clinical laboratories, pharmacies, poison control
centers, other health care organizations, and animal
health organizations within such States.
(2) Eligibility.--To be eligible to receive a grant
under paragraph (1), the State or consortium of States
shall submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require, including an assurance
that the State or consortium of States will submit to
the Secretary--
(A) reports of such data, information, and
metrics as the Secretary may require;
(B) a report on the effectiveness of the
systems funded under the grant; and
(C) a description of the manner in which
grant funds will be used to enhance the
timelines and comprehensiveness of efforts to
detect, respond to, and manage potentially
catastrophic infectious disease outbreaks and
public health emergencies.
(3) Use of funds.--A State or consortium of States
that receives an award under this subsection--
(A) shall establish, enhance, or operate a
coordinated public health situational awareness
system for regional or Statewide early
detection of, rapid response to, and management
of potentially catastrophic infectious disease
outbreaks and public health emergencies;
(B) may award grants or contracts to
entities described in paragraph (1) within or
serving such State to assist such entities in
improving the operation of information
technology systems, facilitating the secure
exchange of data and information, and training
personnel to enhance the operation of the
system described in subparagraph (A); and
(C) may conduct a pilot program for the
development of multi-State telehealth network
test beds that build on, enhance, and securely
link existing State and local telehealth
programs to prepare for, monitor, respond to,
and manage the events of public health
emergencies, facilitate coordination and
communication among medical, public health, and
emergency response agencies, and provide
medical services through telehealth initiatives
within the States that are involved in such a
multi-State telehealth network test bed.
(4) Limitation.--Information technology systems
acquired or implemented using grants awarded under this
section must be compliant with--
(A) interoperability and other
technological standards, as determined by the
Secretary; and
(B) data collection and reporting
requirements for the network described in
subsection (d).
(5) Independent evaluation.--Not later than 4 years
after the date of enactment of the Pandemic and All-
Hazards Preparedness Act, the Government Accountability
Office shall conduct an independent evaluation, and
submit to the Secretary and the appropriate committees
of Congress a report concerning the activities
conducted under this subsection and subsection (d).
(f) Telehealth Enhancements for Emergency Response.--
(1) Evaluation.--The Secretary, in consultation
with the Federal Communications Commission and other
relevant Federal agencies, shall--
(A) conduct an inventory of telehealth
initiatives in existence on the date of
enactment of the Pandemic and All-Hazards
Preparedness Act, including--
(i) the specific location of
network components;
(ii) the medical, technological,
and communications capabilities of such
components;
(iii) the functionality of such
components; and
(iv) the capacity and ability of
such components to handle increased
volume during the response to a public
health emergency;
(B) identify methods to expand and
interconnect the regional health information
networks funded by the Secretary, the State and
regional broadband networks funded through the
rural health care support mechanism pilot
program funded by the Federal Communications
Commission, and other telehealth networks;
(C) evaluate ways to prepare for, monitor,
respond rapidly to, or manage the events of, a
public health emergency through the enhanced
use of telehealth technologies, including
mechanisms for payment or reimbursement for use
of such technologies and personnel during
public health emergencies;
(D) identify methods for reducing legal
barriers that deter health care professionals
from providing telemedicine services, such as
by utilizing State emergency health care
professional credentialing verification
systems, encouraging States to establish and
implement mechanisms to improve interstate
medical licensure cooperation, facilitating the
exchange of information among States regarding
investigations and adverse actions, and
encouraging States to waive the application of
licensing requirements during a public health
emergency;
(E) evaluate ways to integrate the practice
of telemedicine within the National Disaster
Medical System; and
(F) promote greater coordination among
existing Federal interagency telemedicine and
health information technology initiatives.
(2) Report.--Not later than 12 months after the
date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall prepare and
submit a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives
regarding the findings and recommendations pursuant to
subparagraphs (A) through (F) of paragraph (1).
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, such sums as may
be necessary in each of fiscal years 2007 through 2011.
SEC. 319E. [247D-5] COMBATING ANTIMICROBIAL RESISTANCE.
(a) Task Force.--
(1) In general.--The Secretary shall establish an
Antimicrobial Resistance Task Force to provide advice
and recommendations to the Secretary and coordinate
Federal programs relating to antimicrobial resistance.
The Secretary may appoint or select a committee, or
other organization in existence as of the date of the
enactment of this section, to serve as such a task
force, if such committee, or other organization meets
the requirements of this section.
(2) Members of task force.--The task force
described in paragraph (1) shall be composed of
representatives from such Federal agencies, and shall
seek input from public health constituencies,
manufacturers, veterinary and medical professional
societies and others, as determined to be necessary by
the Secretary, to develop and implement a comprehensive
plan to address the public health threat of
antimicrobial resistance.
(3) Agenda.--
(A) In general.--The task force described
in paragraph (1) shall consider factors the
Secretary considers appropriate, including--
(i) public health factors
contributing to increasing
antimicrobial resistance;
(ii) public health needs to detect
and monitor antimicrobial resistance;
(iii) detection, prevention, and
control strategies for resistant
pathogens;
(iv) the need for improved
information and data collection;
(v) the assessment of the risk
imposed by pathogens presenting a
threat to the public health; and
(vi) any other issues which the
Secretary determines are relevant to
antimicrobial resistance.
(B) Detection and control.--The Secretary,
in consultation with the task force described
in paragraph (1) and State and local public
health officials, shall--
(i) develop, improve, coordinate or
enhance participation in a surveillance
plan to detect and monitor emerging
antimicrobial resistance; and
(ii) develop, improve, coordinate
or enhance participation in an
integrated information system to
assimilate, analyze, and exchange
antimicrobial resistance data between
public health departments.
(4) Meetings.--The task force described under
paragraph (1) shall convene not less than twice a year,
or more frequently as the Secretary determines to be
appropriate.
(b) Research and Development of New Antimicrobial Drugs and
Diagnostics.--The Secretary and the Director of Agricultural
Research Services, consistent with the recommendations of the
task force established under subsection (a), shall directly or
through awards of grants or cooperative agreements to public or
private entities provide for the conduct of research,
investigations, experiments, demonstrations, and studies in the
health sciences that are related to--
(1) the development of new therapeutics, including
vaccines and antimicrobials, against resistant
pathogens;
(2) the development or testing of medical
diagnostics to detect pathogens resistant to
antimicrobials;
(3) the epidemiology, mechanisms, and pathogenesis
of antimicrobial resistance;
(4) the sequencing of the genomes, or other DNA
analysis, or other comparative analysis, of priority
pathogens (as determined by the Director of the
National Institutes of Health in consultation with the
task force established under subsection (a)), in
collaboration and coordination with the activities of
the Department of Defense and the Joint Genome
Institute of the Department of Energy; and
(5) other relevant research areas.
(c) Education of Medical and Public Health Personnel.--The
Secretary, after consultation with the Assistant Secretary for
Health, the Surgeon General, the Director of the Centers for
Disease Control and Prevention, the Administrator of the Health
Resources and Services Administration, the Director of the
Agency for Healthcare Research and Quality, members of the task
force described in subsection (a), professional organizations
and societies, and such other public health officials as may be
necessary, shall--
(1) develop and implement educational programs to
increase the awareness of the general public with
respect to the public health threat of antimicrobial
resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to
instruct health care professionals in the prudent use
of antibiotics; and
(3) develop and implement programs to train
laboratory personnel in the recognition or
identification of resistance in pathogens.
(d) Grants.--
(1) In general.--The Secretary shall award
competitive grants to eligible entities to enable such
entities to increase the capacity to detect, monitor,
and combat antimicrobial resistance.
(2) Eligible entities.--Eligible entities for
grants under paragraph (1) shall be State or local
public health agencies, Indian tribes or tribal
organizations, or other public or private nonprofit
entities.
(3) Use of funds.--An eligible entity receiving a
grant under paragraph (1) shall use funds from such
grant for activities that are consistent with the
factors identified by the task force under subsection
(a)(3), which may include activities that--
(A) provide training to enable such entity
to identify patterns of resistance rapidly and
accurately;
(B) develop, improve, coordinate or enhance
participation in information systems by which
data on resistant infections can be shared
rapidly among relevant national, State, and
local health agencies and health care
providers; and
(C) develop and implement policies to
control the spread of antimicrobial resistance.
(e) Grants for Demonstration Programs.--
(1) In general.--The Secretary shall award
competitive grants to eligible entities to establish
demonstration programs to promote judicious use of
antimicrobial drugs or control the spread of
antimicrobial-resistant pathogens.
(2) Eligible entities.--Eligible entities for
grants under paragraph (1) may include hospitals,
clinics, institutions of long-term care, professional
medical societies, schools or programs that train
medical laboratory personnel, or other public or
private nonprofit entities.
(3) Technical assistance.--The Secretary shall
provide appropriate technical assistance to eligible
entities that receive grants under paragraph (1).
(f ) Supplement Not Supplant.--Funds appropriated under
this section shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities
under this section.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $40,000,000 for
fiscal year 2001, $25,000,000 for each of the fiscal years 2002
and 2003, and such sums as may be necessary for each of the
fiscal years 2004 through 2006.
SEC. 319F. [247D-6] PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST
ATTACK.
(a) All-Hazards Public Health and Medical Response
Curricula and Training.--
(1) In general.--The Secretary, in collaboration
with the Secretary of Defense, and in consultation with
relevant public and private entities, shall develop
core health and medical response curricula and
trainings by adapting applicable existing curricula and
training programs to improve responses to public health
emergencies.
(2) Curriculum.--The public health and medical
response training program may include course work
related to--
(A) medical management of casualties,
taking into account the needs of at-risk
individuals;
(B) public health aspects of public health
emergencies;
(C) mental health aspects of public health
emergencies;
(D) national incident management, including
coordination among Federal, State, local,
tribal, international agencies, and other
entities; and
(E) protecting health care workers and
health care first responders from workplace
exposures during a public health emergency.
(3) Peer review.--On a periodic basis, products
prepared as part of the program shall be rigorously
tested and peer-reviewed by experts in the relevant
fields.
(4) Credit.--The Secretary and the Secretary of
Defense shall--
(A) take into account continuing
professional education requirements of public
health and healthcare professions; and
(B) cooperate with State, local, and tribal
accrediting agencies and with professional
associations in arranging for students enrolled
in the program to obtain continuing
professional education credit for program
courses.
(5) Dissemination and training.--
(A) In general.--The Secretary may provide
for the dissemination and teaching of the
materials described in paragraphs (1) and (2)
by appropriate means, as determined by the
Secretary.
(B) Certain entities.--The education and
training activities described in subparagraph
(A) may be carried out by Federal public health
or medical entities, appropriate educational
entities, professional organizations and
societies, private accrediting organizations,
and other nonprofit institutions or entities
meeting criteria established by the Secretary.
(C) Grants and contracts.--In carrying out
this subsection, the Secretary may carry out
activities directly or through the award of
grants and contracts, and may enter into
interagency agreements with other Federal
agencies.
(b) Advice to the Federal Government.--
(1) Required advisory committees.--In coordination
with the working group under subsection (a), the
Secretary shall establish advisory committees in
accordance with paragraphs (2) and (3) to provide
expert recommendations to assist such working groups in
carrying out their respective responsibilities under
subsections (a) and (b) \1\.
---------------------------------------------------------------------------
\1\ Probably should be ``to assist such working group in carrying
out its responsibilities under subsection (a)''. Formerly there were
two working groups, one under subsection (a) and one under subsection
(b). Now there is only the working group under subsection (a). See the
amendments made by sections 104(a) and 108 of Public Law 107-188 (116
Stat. 605, 609).
---------------------------------------------------------------------------
(2) National advisory committee on children and
terrorism \2\.--
---------------------------------------------------------------------------
\2\ The heading for subsection (b)(2) probably should read
``National advisory committee on at-risk individuals and public health
emergencies''. The amendment made by section 301(d)(1) of Public Law
109-417 (120 Stat. 2854) to strike ``Children and terrorism'' and
insert ``At-risk individuals and public health emergencies'' could not
be executed due to incorrect capitalization of the word ``Children'' in
the matter to be struck. Also the letter ``A'' in the word ``At-risk''
in the inserted text probably should be lowercase type.
---------------------------------------------------------------------------
(A) In general.--For purposes of paragraph
(1), the Secretary shall establish an advisory
committee to be known as the National Advisory
Committee on At-Risk Individuals and Public
Health Emergencies (referred to in this
paragraph as the ``Advisory Committee'').
(B) Duties.--The Advisory Committee shall
provide recommendations regarding--
(i) the preparedness of the health
care (including mental health care)
system to respond to public health
emergencies as they relate to at-risk
individuals;
(ii) needed changes to the health
care and emergency medical service
systems and emergency medical services
protocols to meet the special needs of
at-risk individuals; and
(iii) changes, if necessary, to the
national stockpile under section 121 of
the Public Health Security and
Bioterrorism Preparedness and Response
Act of 2002 to meet the emergency
health security of at-risk individuals.
(C) Composition.--The Advisory Committee
shall be composed of such Federal officials as
may be appropriate to address the special needs
of the diverse population groups of at-risk
populations.
(D) Termination.--The Advisory Committee
terminates six years after the date of the
enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of
2002.
(3) Emergency public information and communications
advisory committee.--
(A) In general.--For purposes of paragraph
(1), the Secretary shall establish an advisory
committee to be known as the Emergency Public
Information and Communications Advisory
Committee (referred to in this paragraph as the
``EPIC Advisory Committee'').
(B) Duties.--The EPIC Advisory Committee
shall make recommendations to the Secretary and
report on appropriate ways to communicate
public health information regarding
bioterrorism and other public health
emergencies to the public.
(C) Composition.--The EPIC Advisory
Committee shall be composed of individuals
representing a diverse group of experts in
public health, medicine, communications,
behavioral psychology, and other areas
determined appropriate by the Secretary.
(D) Dissemination.--The Secretary shall
review the recommendations of the EPIC Advisory
Committee and ensure that appropriate
information is disseminated to the public.
(E) Termination.--The EPIC Advisory
Committee terminates one year after the date of
the enactment of Public Health Security and
Bioterrorism Preparedness and Response Act of
2002.
(c) Expansion of Epidemic Intelligence Service Program.--
The Secretary may establish 20 officer positions in the
Epidemic Intelligence Service Program, in addition to the
number of the officer positions offered under such Program in
2006, for individuals who agree to participate, for a period of
not less than 2 years, in the Career Epidemiology Field Officer
program in a State, local, or tribal health department that
serves a health professional shortage area (as defined under
section 332(a)), a medically underserved population (as defined
under section 330(b)(3)), or a medically underserved area or
area at high risk of a public health emergency as designated by
the Secretary.
(d) Centers for Public Health Preparedness; Core Curricula
and Training.--
(1) In general.--The Secretary may establish at
accredited schools of public health, Centers for Public
Health Preparedness (hereafter referred to in this
section as the ``Centers'').
(2) Eligibility.--To be eligible to receive an
award under this subsection to establish a Center, an
accredited school of public health shall agree to
conduct activities consistent with the requirements of
this subsection.
(3) Core curricula.--The Secretary, in
collaboration with the Centers and other public or
private entities shall establish core curricula based
on established competencies leading to a 4-year
bachelor's degree, a graduate degree, a combined
bachelor and master's degree, or a certificate program,
for use by each Center. The Secretary shall disseminate
such curricula to other accredited schools of public
health and other health professions schools determined
appropriate by the Secretary, for voluntary use by such
schools.
(4) Core competency-based training program.--The
Secretary, in collaboration with the Centers and other
public or private entities shall facilitate the
development of a competency-based training program to
train public health practitioners. The Centers shall
use such training program to train public health
practitioners. The Secretary shall disseminate such
training program to other accredited schools of public
health, health professions schools, and other public or
private entities as determined by the Secretary, for
voluntary use by such entities.
(5) Content of core curricula and training
program.--The Secretary shall ensure that the core
curricula and training program established pursuant to
this subsection respond to the needs of State, local,
and tribal public health authorities and integrate and
emphasize essential public health security capabilities
consistent with section 2802(b)(2).
(6) Academic-workforce communication.--As a
condition of receiving funding from the Secretary under
this subsection, a Center shall collaborate with a
State, local, or tribal public health department to--
(A) define the public health preparedness
and response needs of the community involved;
(B) assess the extent to which such needs
are fulfilled by existing preparedness and
response activities of such school or health
department, and how such activities may be
improved;
(C) prior to developing new materials or
trainings, evaluate and utilize relevant
materials and trainings developed by others
Centers; and
(D) evaluate community impact and the
effectiveness of any newly developed materials
or trainings.
(7) Public health systems research.--In
consultation with relevant public and private entities,
the Secretary shall define the existing knowledge base
for public health preparedness and response systems,
and establish a research agenda based on Federal,
State, local, and tribal public health preparedness
priorities. As a condition of receiving funding from
the Secretary under this subsection, a Center shall
conduct public health systems research that is
consistent with the agenda described under this
paragraph.
(e) Accelerated Research and Development on Priority
Pathogens and Countermeasures.--
(1) In general.--With respect to pathogens of
potential use in a bioterrorist attack, and other
agents that may cause a public health emergency, the
Secretary, taking into consideration any
recommendations of the working group under subsection
(a), shall conduct, and award grants, contracts, or
cooperative agreements for, research, investigations,
experiments, demonstrations, and studies in the health
sciences relating to--
(A) the epidemiology and pathogenesis of
such pathogens;
(B) the sequencing of the genomes, or other
DNA analysis, or other comparative analysis, of
priority pathogens (as determined by the
Director of the National Institutes of Health
in consultation with the working group
established in subsection (a)), in
collaboration and coordination with the
activities of the Department of Defense and the
Joint Genome Institute of the Department of
Energy;
(C) the development of priority
countermeasures; and
(D) other relevant areas of research;
with consideration given to the needs of children and
other vulnerable populations.
(2) Priority.--The Secretary shall give priority
under this section to the funding of research and other
studies related to priority countermeasures.
(3) Role of department of veterans affairs.--In
carrying out paragraph (1), the Secretary shall
consider using the biomedical research and development
capabilities of the Department of Veterans Affairs, in
conjunction with that Department's affiliations with
health-professions universities. When advantageous to
the Government in furtherance of the purposes of such
paragraph, the Secretary may enter into cooperative
agreements with the Secretary of Veterans Affairs to
achieve such purposes.
(4) Priority countermeasures.--For purposes of this
section, the term ``priority countermeasure'' means a
drug, biological product, device, vaccine, vaccine
adjuvant, antiviral, or diagnostic test that the
Secretary determines to be--
(A) a priority to treat, identify, or
prevent infection by a biological agent or
toxin listed pursuant to section 351A(a)(1), or
harm from any other agent that may cause a
public health emergency; or
(B) a priority to treat, identify, or
prevent conditions that may result in adverse
health consequences or death and may be caused
by the administering of a drug, biological
product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that is a
priority under subparagraph (A).
(f) Authorization of Appropriations.--
(1) Fiscal year 2007.--There are authorized to be
appropriated to carry out this section for fiscal year
2007--
(A) to carry out subsection (a)--
(i) $5,000,000 to carry out
paragraphs (1) through (4); and
(ii) $7,000,000 to carry out
paragraph (5);
(B) to carry out subsection (c),
$3,000,000; and
(C) to carry out subsection (d),
$31,000,000, of which $5,000,000 shall be used
to carry out paragraphs (3) through (5) of such
subsection.
(2) Subsequent fiscal years.--There are authorized
to be appropriated such sums as may be necessary to
carry out this section for fiscal year 2008 and each
subsequent fiscal year.
SEC. 319F-1. [247D-6A] AUTHORITY FOR USE OF CERTAIN PROCEDURES
REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND
DEVELOPMENT ACTIVITIES. \2\
(a) In General.--
(1) Authority.--In conducting and supporting
research and development activities regarding
countermeasures under section 319F(h), the Secretary
may conduct and support such activities in accordance
with this section and, in consultation with the
Director of the National Institutes of Health, as part
of the program under section 446, if the activities
concern qualified countermeasures.
---------------------------------------------------------------------------
\2\ Section 5 of Public Law 108-276 (118 Stat. 860) requires
various reports regarding section 319F-1 and related provisions of law.
Section 5 is included in the appendix to this compilation.
---------------------------------------------------------------------------
(2) Definitions.--In this section:
(A) Qualified countermeasure.--The term
``qualified countermeasure'' means a drug (as
that term is defined by section 201(g)(1) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(g)(1))), biological product (as that
term is defined by section 351(i) of this Act
(42 U.S.C. 262(i))), or device (as that term is
defined by section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h))),
that the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of
the Homeland Security Act of 2002) to--
(i) diagnose, mitigate, prevent, or
treat harm from any biological agent
(including organisms that cause an
infectious disease) or toxin, chemical,
radiological, or nuclear agent that may
cause a public health emergency
affecting national security; or
(ii) diagnose, mitigate, prevent,
or treat harm from a condition that may
result in adverse health consequences
or death and may be caused by
administering a drug, biological
product, or device that is used as
described in this subparagraph.
(B) Infectious disease.--The term
``infectious disease'' means a disease
potentially caused by a pathogenic organism
(including a bacteria, virus, fungus, or
parasite) that is acquired by a person and that
reproduces in that person.
(3) Interagency cooperation.--
(A) In general.--In carrying out activities
under this section, the Secretary is
authorized, subject to subparagraph (B), to
enter into interagency agreements and other
collaborative undertakings with other agencies
of the United States Government.
(B) Limitation.--An agreement or
undertaking under this paragraph shall not
authorize another agency to exercise the
authorities provided by this section.
(4) Availability of facilities to the secretary.--
In any grant, contract, or cooperative agreement
entered into under the authority provided in this
section with respect to a biocontainment laboratory or
other related or ancillary specialized research
facility that the Secretary determines necessary for
the purpose of performing, administering, or supporting
qualified countermeasure research and development, the
Secretary may provide that the facility that is the
object of such grant, contract, or cooperative
agreement shall be available as needed to the Secretary
to respond to public health emergencies affecting
national security.
(5) Transfers of qualified countermeasures.--Each
agreement for an award of a grant, contract, or
cooperative agreement under section 319F(h) for the
development of a qualified countermeasure shall provide
that the recipient of the award will comply with all
applicable export-related controls with respect to such
countermeasure.
(b) Expedited Procurement Authority.--
(1) Increased simplified acquisition threshold for
qualified countermeasure procurements.--
(A) In general.--For any procurement by the
Secretary of property or services for use (as
determined by the Secretary) in performing,
administering, or supporting qualified
countermeasure research or development
activities under this section that the
Secretary determines necessary to respond to
pressing research and development needs under
this section, the amount specified in section
4(11) of the Office of Federal Procurement
Policy Act (41 U.S.C. 403(11)), as applicable
pursuant to section 302A(a) of the Federal
Property and Administrative Services Act of
1949 (41 U.S.C. 252a(a)), shall be deemed to be
$25,000,000 in the administration, with respect
to such procurement, of--
(i) section 303(g)(1)(A) of the
Federal Property and Administrative
Services Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its implementing
regulations; and
(ii) section 302A(b) of such Act
(41 U.S.C. 252a(b)) and its
implementing regulations.
(B) Application of certain provisions.--
Notwithstanding subparagraph (A) and the
provision of law and regulations referred to in
such subparagraph, each of the following
provisions shall apply to procurements
described in this paragraph to the same extent
that such provisions would apply to such
procurements in the absence of subparagraph
(A):
(i) Chapter 37 of title 40, United
States Code (relating to contract work
hours and safety standards).
(ii) Subsections (a) and (b) of
section 7 of the Anti-Kickback Act of
1986 (41 U.S.C. 57(a) and (b)).
(iii) Section 304C of the Federal
Property and Administrative Services
Act of 1949 (41 U.S.C. 254d) (relating
to the examination of contractor
records).
(iv) Section 3131 of title 40,
United States Code (relating to bonds
of contractors of public buildings or
works).
(v) Subsection (a) of section 304
of the Federal Property and
Administrative Services Act of 1949 (41
U.S.C. 254(a)) (relating to contingent
fees to middlemen).
(vi) Section 6002 of the Solid
Waste Disposal Act (42 U.S.C. 6962).
(vii) Section 1354 of title 31,
United States Code (relating to the
limitation on the use of appropriated
funds for contracts with entities not
meeting veterans employment reporting
requirements).
(C) Internal controls to be instituted.--
The Secretary shall institute appropriate
internal controls for procurements that are
under this paragraph, including requirements
with regard to documenting the justification
for use of the authority in this paragraph with
respect to the procurement involved.
(D) Authority to limit competition.--In
conducting a procurement under this paragraph,
the Secretary may not use the authority
provided for under subparagraph (A) to conduct
a procurement on a basis other than full and
open competition unless the Secretary
determines that the mission of the BioShield
Program under the Project BioShield Act of 2004
would be seriously impaired without such a
limitation.
(2) Procedures other than full and open
competition.--
(A) In general.--In using the authority
provided in section 303(c)(1) of title III of
the Federal Property and Administrative
Services Act of 1949 (41 U.S.C. 253(c)(1)) to
use procedures other than competitive
procedures in the case of a procurement
described in paragraph (1) of this subsection,
the phrase ``available from only one
responsible source'' in such section 303(c)(1)
shall be deemed to mean ``available from only
one responsible source or only from a limited
number of responsible sources''.
(B) Relation to other authorities.--The
authority under subparagraph (A) is in addition
to any other authority to use procedures other
than competitive procedures.
(C) Applicable government-wide
regulations.--The Secretary shall implement
this paragraph in accordance with government-
wide regulations implementing such section
303(c)(1) (including requirements that offers
be solicited from as many potential sources as
is practicable under the circumstances, that
required notices be published, and that
submitted offers be considered), as such
regulations apply to procurements for which an
agency has authority to use procedures other
than competitive procedures when the property
or services needed by the agency are available
from only one responsible source or only from a
limited number of responsible sources and no
other type of property or services will satisfy
the needs of the agency.
(3) Increased micropurchase threshold.--
(A) In general.--For a procurement
described by paragraph (1), the amount
specified in subsections (c), (d), and (f) of
section 32 of the Office of Federal Procurement
Policy Act (41 U.S.C. 428) shall be deemed to
be $15,000 in the administration of that
section with respect to such procurement.
(B) Internal controls to be instituted.--
The Secretary shall institute appropriate
internal controls for purchases that are under
this paragraph and that are greater than
$2,500.
(C) Exception to preference for purchase
card mechanism.--No provision of law
establishing a preference for using a
Government purchase card method for purchases
shall apply to purchases that are under this
paragraph and that are greater than $2,500.
(4) Review.--
(A) Review allowed.--Notwithstanding
subsection (f), section 1491 of title 28,
United States Code, and section 3556 of title
31 of such Code, review of a contracting agency
decision relating to a procurement described in
paragraph (1) may be had only by filing a
protest--
(i) with a contracting agency; or
(ii) with the Comptroller General
under subchapter V of chapter 35 of
title 31, United States Code.
(B) Override of stay of contract award or
performance committed to agency discretion.--
Notwithstanding section 1491 of title 28,
United States Code, and section 3553 of title
31 of such Code, the following authorizations
by the head of a procuring activity are
committed to agency discretion:
(i) An authorization under section
3553(c)(2) of title 31, United States
Code, to award a contract for a
procurement described in paragraph (1)
of this subsection.
(ii) An authorization under section
3553(d)(3)(C) of such title to perform
a contract for a procurement described
in paragraph (1) of this subsection.
(c) Authority to Expedite Peer Review.--
(1) In general.--The Secretary may, as the
Secretary determines necessary to respond to pressing
qualified countermeasure research and development needs
under this section, employ such expedited peer review
procedures (including consultation with appropriate
scientific experts) as the Secretary, in consultation
with the Director of NIH, deems appropriate to obtain
assessment of scientific and technical merit and likely
contribution to the field of qualified countermeasure
research, in place of the peer review and advisory
council review procedures that would be required under
sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
406(a)(3)(A), 492, and 494, as applicable to a grant,
contract, or cooperative agreement--
(A) that is for performing, administering,
or supporting qualified countermeasure research
and development activities; and
(B) the amount of which is not greater than
$1,500,000.
(2) Subsequent phases of research.--The Secretary's
determination of whether to employ expedited peer
review with respect to any subsequent phases of a
research grant, contract, or cooperative agreement
under this section shall be determined without regard
to the peer review procedures used for any prior peer
review of that same grant, contract, or cooperative
agreement. Nothing in the preceding sentence may be
construed to impose any requirement with respect to
peer review not otherwise required under any other law
or regulation.
(d) Authority for Personal Services Contracts.--
(1) In general.--For the purpose of performing,
administering, or supporting qualified countermeasure
research and development activities, the Secretary may,
as the Secretary determines necessary to respond to
pressing qualified countermeasure research and
development needs under this section, obtain by
contract (in accordance with section 3109 of title 5,
United States Code, but without regard to the
limitations in such section on the period of service
and on pay) the personal services of experts or
consultants who have scientific or other professional
qualifications, except that in no case shall the
compensation provided to any such expert or consultant
exceed the daily equivalent of the annual rate of
compensation for the President.
(2) Federal tort claims act coverage.--
(A) In general.--A person carrying out a
contract under paragraph (1), and an officer,
employee, or governing board member of such
person, shall, subject to a determination by
the Secretary, be deemed to be an employee of
the Department of Health and Human Services for
purposes of claims under sections 1346(b) and
2672 of title 28, United States Code, for money
damages for personal injury, including death,
resulting from performance of functions under
such contract.
(B) Exclusivity of remedy.--The remedy
provided by subparagraph (A) shall be exclusive
of any other civil action or proceeding by
reason of the same subject matter against the
entity involved (person, officer, employee, or
governing board member) for any act or omission
within the scope of the Federal Tort Claims
Act.
(C) Recourse in case of gross misconduct or
contract violation.--
(i) In general.--Should payment be
made by the United States to any
claimant bringing a claim under this
paragraph, either by way of
administrative determination,
settlement, or court judgment, the
United States shall have,
notwithstanding any provision of State
law, the right to recover against any
entity identified in subparagraph (B)
for that portion of the damages so
awarded or paid, as well as interest
and any costs of litigation, resulting
from the failure of any such entity to
carry out any obligation or
responsibility assumed by such entity
under a contract with the United States
or from any grossly negligent or
reckless conduct or intentional or
willful misconduct on the part of such
entity.
(ii) Venue.--The United States may
maintain an action under this
subparagraph against such entity in the
district court of the United States in
which such entity resides or has its
principal place of business.
(3) Internal controls to be instituted.--
(A) In general.--The Secretary shall
institute appropriate internal controls for
contracts under this subsection, including
procedures for the Secretary to make a
determination of whether a person, or an
officer, employee, or governing board member of
a person, is deemed to be an employee of the
Department of Health and Human Services
pursuant to paragraph (2).
(B) Determination of employee status to be
final.--A determination by the Secretary under
subparagraph (A) that a person, or an officer,
employee, or governing board member of a
person, is or is not deemed to be an employee
of the Department of Health and Human Services
shall be final and binding on the Secretary and
the Attorney General and other parties to any
civil action or proceeding.
(4) Number of personal services contracts
limited.--The number of experts and consultants whose
personal services are obtained under paragraph (1)
shall not exceed 30 at any time.
(e) Streamlined Personnel Authority.--
(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under
this section, without regard to those provisions of
title 5, United States Code, governing appointments in
the competitive service, and without regard to the
provisions of chapter 51 and subchapter III of chapter
53 of such title relating to classification and General
Schedule pay rates, appoint professional and technical
employees, not to exceed 30 such employees at any time,
to positions in the National Institutes of Health to
perform, administer, or support qualified
countermeasure research and development activities in
carrying out this section.
(2) Limitations.--The authority provided for under
paragraph (1) shall be exercised in a manner that--
(A) recruits and appoints individuals based
solely on their abilities, knowledge, and
skills;
(B) does not discriminate for or against
any applicant for employment on any basis
described in section 2302(b)(1) of title 5,
United States Code;
(C) does not allow an official to appoint
an individual who is a relative (as defined in
section 3110(a)(3) of such title) of such
official;
(D) does not discriminate for or against an
individual because of the exercise of any
activity described in paragraph (9) or (10) of
section 2302(b) of such title; and
(E) accords a preference, among equally
qualified persons, to persons who are
preference eligibles (as defined in section
2108(3) of such title).
(3) Internal controls to be instituted.--The
Secretary shall institute appropriate internal controls
for appointments under this subsection.
(f) Actions Committed to Agency Discretion.--Actions by the
Secretary under the authority of this section are committed to
agency discretion.
SEC. 319F-2. [247D-6B] STRATEGIC NATIONAL STOCKPILE AND SECURITY
COUNTERMEASURE PROCUREMENTS. \1\
(a) Strategic National Stockpile.--
(1) In general.--The Secretary, in collaboration
with the Director of the Centers for Disease Control
and Prevention, and in coordination with the Secretary
of Homeland Security (referred to in this section as
the ``Homeland Security Secretary''), shall maintain a
stockpile or stockpiles of drugs, vaccines and other
biological products, medical devices, and other
supplies in such numbers, types, and amounts as are
determined by the Secretary to be appropriate and
practicable, taking into account other available
sources, to provide for the emergency health security
of the United States, including the emergency health
security of children and other vulnerable populations,
in the event of a bioterrorist attack or other public
health emergency. The Secretary shall conduct an annual
review (taking into account at-risk individuals) of the
contents of the stockpile, including non-pharmaceutical
supplies, and make necessary additions or modifications
to the contents based on such review.
---------------------------------------------------------------------------
\1\ Section 5 of Public Law 108-276 (118 Stat. 860) requires
various reports regarding section 319F-2 and related provisions of law.
Section 5 is included in the appendix to this compilation.
---------------------------------------------------------------------------
(2) Procedures.--The Secretary, in managing the
stockpile under paragraph (1), shall--
(A) consult with the working group under
section 319F(a);
(B) ensure that adequate procedures are
followed with respect to such stockpile for
inventory management and accounting, and for
the physical security of the stockpile;
(C) in consultation with Federal, State,
and local officials, take into consideration
the timing and location of special events;
(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis to
ensure that emerging threats, advanced
technologies, and new countermeasures are
adequately considered;
(E) devise plans for the effective and
timely supply-chain management of the
stockpile, in consultation with appropriate
Federal, State and local agencies, and the
public and private health care infrastructure;
(F) deploy the stockpile as required by the
Secretary of Homeland Security to respond to an
actual or potential emergency;
(G) deploy the stockpile at the discretion
of the Secretary to respond to an actual or
potential public health emergency or other
situation in which deployment is necessary to
protect the public health or safety; and
(H) ensure the adequate physical security
of the stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The Secretary shall award
contracts, enter into cooperative agreements, or carry
out such other activities as may reasonably be required
in order to ensure that the stockpile under subsection
(a) includes an amount of vaccine against smallpox as
determined by such Secretary to be sufficient to meet
the health security needs of the United States.
(2) Rule of construction.--Nothing in this section
shall be construed to limit the private distribution,
purchase, or sale of vaccines from sources other than
the stockpile described in subsection (a).
(c) Additional Authority Regarding Procurement of Certain
Countermeasures; Availability of Special Reserve Fund.--
(1) In general.--
(A) Use of fund.--A security countermeasure
may, in accordance with this subsection, be
procured with amounts in the special reserve
fund under paragraph (10).
(B) Security countermeasure.--For purposes
of this subsection, the term ``security
countermeasure'' means a drug (as that term is
defined by section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1))), biological product (as that term
is defined by section 351(i) of this Act (42
U.S.C. 262(i))), or device (as that term is
defined by section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h)))
that--
(i)(I) the Secretary determines to
be a priority (consistent with sections
302(2) and 304(a) of the Homeland
Security Act of 2002) to diagnose,
mitigate, prevent, or treat harm from
any biological, chemical, radiological,
or nuclear agent identified as a
material threat under paragraph
(2)(A)(ii), or to diagnose, mitigate,
prevent, or treat harm from a condition
that may result in adverse health
consequences or death and may be caused
by administering a drug, biological
product, or device against such an
agent;
(II) the Secretary determines under
paragraph (2)(B)(ii) to be a necessary
countermeasure; and
(III)(aa) is approved or cleared
under chapter V of the Federal Food,
Drug, and Cosmetic Act or licensed
under section 351 of this Act; or
(bb) is a countermeasure for which
the Secretary determines that
sufficient and satisfactory clinical
experience or research data (including
data, if available, from pre-clinical
and clinical trials) support a
reasonable conclusion that the
countermeasure will qualify for
approval or licensing within eight
years after the date of a determination
under paragraph (5); or
(ii) is authorized for emergency
use under section 564 of the Federal
Food, Drug, and Cosmetic Act.
(2) Determination of material threats.--
(A) Material threat.--The Homeland Security
Secretary, in consultation with the Secretary
and the heads of other agencies as appropriate,
shall on an ongoing basis--
(i) assess current and emerging
threats of chemical, biological,
radiological, and nuclear agents; and
(ii) determine which of such agents
present a material threat against the
United States population sufficient to
affect national security.
(B) Public health impact; necessary
countermeasures.--The Secretary shall on an
ongoing basis--
(i) assess the potential public
health consequences for the United
States population of exposure to agents
identified under subparagraph (A)(ii);
and
(ii) determine, on the basis of
such assessment, the agents identified
under subparagraph (A)(ii) for which
countermeasures are necessary to
protect the public health.
(C) Notice to congress.--The Secretary and
the Homeland Security Secretary shall promptly
notify the designated congressional committees
(as defined in paragraph (10)) that a
determination has been made pursuant to
subparagraph (A) or (B).
(D) Assuring access to threat
information.--In making the assessment and
determination required under subparagraph (A),
the Homeland Security Secretary shall use all
relevant information to which such Secretary is
entitled under section 202 of the Homeland
Security Act of 2002, including but not limited
to information, regardless of its level of
classification, relating to current and
emerging threats of chemical, biological,
radiological, and nuclear agents.
(3) Assessment of availability and appropriateness
of countermeasures.--
(A) In general.--The Secretary, in
consultation with the Homeland Security
Secretary, shall assess on an ongoing basis the
availability and appropriateness of specific
countermeasures to address specific threats
identified under paragraph (2).
(B) Information.--The Secretary shall
institute a process for making publicly
available the results of assessments under
subparagraph (A) while withholding such
information as--
(i) would, in the judgment of the
Secretary, tend to reveal public health
vulnerabilities; or
(ii) would otherwise be exempt from
disclosure under section 552 of title
5, United States Code.
(4) Call for development of countermeasures;
commitment for recommendation for procurement.--
(A) Proposal to the president.--If,
pursuant to an assessment under paragraph (3),
the Homeland Security Secretary and the
Secretary make a determination that a
countermeasure would be appropriate but is
either
currently not developed or unavailable for
procurement as a security countermeasure or is
approved, licensed, or cleared only for
alternative uses, such Secretaries may jointly
submit to the President a proposal to--
(i) issue a call for the
development of such countermeasure; and
(ii) make a commitment that, upon
the first development of such
countermeasure that meets the
conditions for procurement under
paragraph (5), the Secretaries will,
based in part on information obtained
pursuant to such call, make a
recommendation under paragraph (6) that
the special reserve fund under
paragraph (10) be made available for
the procurement of such countermeasure.
(B) Countermeasure specifications.--The
Homeland Security Secretary and the Secretary
shall, to the extent practicable, include in
the proposal under subparagraph (A)--
(i) estimated quantity of purchase
(in the form of number of doses or
number of effective courses of
treatments regardless of dosage form);
(ii) necessary measures of minimum
safety and effectiveness;
(iii) estimated price for each dose
or effective course of treatment
regardless of dosage form; and
(iv) other information that may be
necessary to encourage and facilitate
research, development, and manufacture
of the countermeasure or to provide
specifications for the countermeasure.
(C) Presidential approval.--If the
President approves a proposal under
subparagraph (A), the Homeland Security
Secretary and the Secretary shall make known to
persons who may respond to a call for the
countermeasure involved--
(i) the call for the
countermeasure;
(ii) specifications for the
countermeasure under subparagraph (B);
and
(iii) the commitment described in
subparagraph (A)(ii).
(5) Secretary's determination of countermeasures
appropriate for funding from special reserve fund.--
(A) In general.--The Secretary, in
accordance with the provisions of this
paragraph, shall identify specific security
countermeasures that the Secretary determines,
in consultation with the Homeland Security
Secretary, to be appropriate for inclusion in
the stockpile under subsection (a) pursuant to
procurements made with amounts in the special
reserve fund under paragraph (10) (referred to
in this subsection individually as a
``procurement under this subsection'').
(B) Requirements.--In making a
determination under subparagraph (A) with
respect to a security countermeasure, the
Secretary shall determine and consider the
following:
(i) The quantities of the product
that will be needed to meet the
stockpile needs.
(ii) The feasibility of production
and delivery within eight years of
sufficient quantities of the product.
(iii) Whether there is a lack of a
significant commercial market for the
product at the time of procurement,
other than as a security
countermeasure.
(6) Recommendation for president's approval.--
(A) Recommendation for procurement.--In the
case of a security countermeasure that the
Secretary has, in accordance with paragraphs
(3) and (5), determined to be appropriate for
procurement under this subsection, the Homeland
Security Secretary and the Secretary shall
jointly submit to the President, in
coordination with the Director of the Office of
Management and Budget, a recommendation that
the special reserve fund under paragraph (10)
be made available for the procurement of such
countermeasure.
(B) Presidential approval.--The special
reserve fund under paragraph (10) is available
for a procurement of a security countermeasure
only if the President has approved a
recommendation under subparagraph (A) regarding
the countermeasure.
(C) Notice to designated congressional
committees.--The Secretary and the Homeland
Security Secretary shall notify the designated
congressional committees of each decision of
the President to approve a recommendation under
subparagraph (A). Such notice shall include an
explanation of the decision to make available
the special reserve fund under paragraph (10)
for procurement of such a countermeasure,
including, where available, the number of,
nature of, and other information concerning
potential suppliers of such countermeasure, and
whether other potential suppliers of the same
or similar countermeasures were considered and
rejected for procurement under this section and
the reasons therefor.
(D) Subsequent specific countermeasures.--
Procurement under this subsection of a security
countermeasure for a particular purpose does
not preclude the subsequent procurement under
this subsection of any other security
countermeasure for such purpose if the
Secretary has determined under paragraph (5)(A)
that such countermeasure is appropriate for
inclusion in the stockpile and if, as
determined by the Secretary, such
countermeasure provides improved safety or
effectiveness, or for other reasons enhances
preparedness to respond to threats of use of a
biological, chemical, radiological, or nuclear
agent. Such a determination by the Secretary is
committed to agency discretion.
(E) Rule of construction.--Recommendations
and approvals under this paragraph apply solely
to determinations that the special reserve fund
under paragraph (10) will be made available for
a procurement of a security countermeasure, and
not to the substance of contracts for such
procurement or other matters relating to awards
of such contracts.
(7) Procurement.--
(A) In general.--For purposes of a
procurement under this subsection that is
approved by the President under paragraph (6),
the Homeland Security Secretary and the
Secretary shall have responsibilities in
accordance with subparagraphs (B) and (C).
(B) Interagency agreement; cost.--The
Homeland Security Secretary shall enter into an
agreement with the Secretary for procurement of
a security countermeasure in accordance with
the provisions of this paragraph. The special
reserve fund under paragraph (10) shall be
available for payments made by the Secretary to
a vendor for such procurement.
(C) Procurement.--
(i) In general.--The Secretary
shall be responsible for--
(I) arranging for
procurement of a security
countermeasure, including
negotiating terms (including
quantity, production schedule,
and price) of, and entering
into, contracts and cooperative
agreements, and for carrying
out such other activities as
may reasonably be required, in
accordance with the provisions
of this subparagraph; and
(II) promulgating such
regulations as the Secretary
determines necessary to
implement the provisions of
this subsection.
(ii) Contract terms.--A contract
for procurements under this subsection
shall (or, as specified below, may)
include the following terms:
(I) Payment conditioned on
delivery.--The contract shall
provide that no payment may be
made until delivery of a
portion, acceptable to the
Secretary, of the total number
of units contracted for, except
that, notwithstanding any other
provision of law, the contract
may provide that, if the
Secretary determines (in the
Secretary's discretion) that an
advance payment, partial
payment for significant
milestones, or payment to
increase manufacturing capacity
is necessary to ensure success
of a project, the Secretary
shall pay an amount, not to
exceed 10 percent of the
contract amount, in advance of
delivery. The Secretary shall,
to the extent practicable, make
the determination of advance
payment at the same time as the
issuance of a solicitation. The
contract shall provide that
such advance payment is
required to be repaid if there
is a failure to perform by the
vendor under the contract. The
contract may also provide for
additional advance payments of
5 percent each for meeting the
milestones specified in such
contract, except that such
payments shall not exceed 50
percent of the total contract
amount. If the specified
milestones are reached, the
advanced payments of 5 percent
shall not be required to be
repaid. Nothing in this
subclause shall be construed as
affecting the rights of vendors
under provisions of law or
regulation (including the
Federal Acquisition Regulation)
relating to the termination of
contracts for the convenience
of the Government.
(II) Discounted payment.--
The contract may provide for a
discounted price per unit of a
product that is not licensed,
cleared, or approved as
described in paragraph
(1)(B)(i)(III)(aa) at the time
of delivery, and may provide
for payment of an additional
amount per unit if the product
becomes so licensed, cleared,
or approved before the
expiration date of the contract
(including an additional amount
per unit of product delivered
before the effective date of
such licensing, clearance, or
approval).
(III) Contract duration.--
The contract shall be for a
period not to exceed five
years, except that, in first
awarding the contract, the
Secretary may provide for a
longer duration, not exceeding
eight years, if the Secretary
determines that complexities or
other difficulties in
performance under the contract
justify such a period. The
contract shall be renewable for
additional periods, none of
which shall exceed five years.
(IV) Storage by vendor.--
The contract may provide that
the vendor will provide storage
for stocks of a product
delivered to the ownership of
the Federal Government under
the contract, for such period
and under such terms and
conditions as the Secretary may
specify, and in such case
amounts from the special
reserve fund under paragraph
(10) shall be available for
costs of shipping, handling,
storage, and related costs for
such product.
(V) Product approval.--The
contract shall provide that the
vendor seek approval,
clearance, or licensing of the
product from the Secretary; for
a timetable for the development
of data and other information
to support such approval,
clearance, or licensing; and
that the Secretary may waive
part or all of this contract
term on request of the vendor
or on the initiative of the
Secretary.
(VI) Non-stockpile
transfers of security
countermeasures.--The contract
shall provide that the vendor
will comply with all applicable
export-related controls with
respect to such countermeasure.
(VII) Sales exclusivity.--
The contract may provide that
the vendor is the exclusive
supplier of the product to the
Federal Government for a
specified period of time, not
to exceed the term of the
contract, on the condition that
the vendor is able to satisfy
the needs of the Government.
During the agreed period of
sales exclusivity, the vendor
shall not assign its rights of
sales exclusivity to another
entity or entities without
approval by the Secretary. Such
a sales exclusivity provision
in such a contract shall
constitute a valid basis for a
sole source procurement under
section 303(c)(1) of the
Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 253(c)(1)).
(VIII) Warm based surge
capacity.--The contract may
provide that the vendor
establish domestic
manufacturing capacity of the
product to ensure that
additional production of the
product is available in the
event that the Secretary
determines that there is a need
to quickly purchase additional
quantities of the product. Such
contract may provide a fee to
the vendor for establishing and
maintaining such capacity in
excess of the initial
requirement for the purchase of
the product. Additionally, the
cost of maintaining the
domestic manufacturing capacity
shall be an allowable and
allocable direct cost of the
contract.
(IX) Contract terms.--The
Secretary, in any contract for
procurement under this section,
may specify--
(aa) the dosing and
administration
requirements for
countermeasures to be
developed and procured;
(bb) the amount of
funding that will be
dedicated by the
Secretary for
development and
acquisition of the
countermeasure; and
(cc) the
specifications the
countermeasure must
meet to qualify for
procurement under a
contract under this
section.
(iii) Availability of simplified
acquisition procedures.--
(I) In general.--If the
Secretary determines that there
is a pressing need for a
procurement of a specific
countermeasure, the amount of
the procurement under this
subsection shall be deemed to
be below the threshold amount
specified in section 4(11) of
the Office of Federal
Procurement Policy Act (41
U.S.C. 403(11)), for purposes
of application to such
procurement, pursuant to
section 302A(a) of the Federal
Property and Administrative
Services Act of 1949 (41 U.S.C.
252a(a)), of--
(aa) section
303(g)(1)(A) of the
Federal Property and
Administrative Services
Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its
implementing
regulations; and
(bb) section
302A(b) of such Act (41
U.S.C. 252a(b)) and its
implementing
regulations.
(II) Application of certain
provisions.--Notwithstanding
subclause (I) and the provision
of law and regulations referred
to in such clause, each of the
following provisions shall
apply to procurements described
in this clause to the same
extent that such provisions
would apply to such
procurements in the absence of
subclause (I):
(aa) Chapter 37 of
title 40, United States
Code (relating to
contract work hours and
safety standards).
(bb) Subsections
(a) and (b) of section
7 of the Anti-Kickback
Act of 1986 (41 U.S.C.
57(a) and (b)).
(cc) Section 304C
of the Federal Property
and Administrative
Services Act of 1949
(41 U.S.C. 254d)
(relating to the
examination of
contractor records).
(dd) Section 3131
of title 40, United
States Code (relating
to bonds of contractors
of public buildings or
works).
(ee) Subsection (a)
of section 304 of the
Federal Property and
Administrative Services
Act of 1949 (41 U.S.C.
254(a)) (relating to
contingent fees to
middlemen).
(ff) Section 6002
of the Solid Waste
Disposal Act (42 U.S.C.
6962).
(gg) Section 1354
of title 31, United
States Code (relating
to the limitation on
the use of appropriated
funds for contracts
with entities not
meeting veterans
employment reporting
requirements).
(III) Internal controls to
be established.--The Secretary
shall establish appropriate
internal controls for
procurements made under this
clause, including requirements
with respect to documentation
of the justification for the
use of the authority provided
under this paragraph with
respect to the procurement
involved.
(IV) Authority to limit
competition.--In conducting a
procurement under this
subparagraph, the Secretary may
not use the authority provided
for under subclause (I) to
conduct a procurement on a
basis other than full and open
competition unless the
Secretary determines that the
mission of the BioShield
Program under the Project
BioShield Act of 2004 would be
seriously impaired without such
a limitation.
(iv) Procedures other than full and
open competition.--
(I) In general.--In using
the authority provided in
section 303(c)(1) of title III
of the Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 253(c)(1)) to
use procedures other than
competitive procedures in the
case of a procurement under
this subsection, the phrase
``available from only one
responsible source'' in such
section 303(c)(1) shall be
deemed to mean ``available from
only one responsible source or
only from a limited number of
responsible sources''.
(II) Relation to other
authorities.--The authority
under subclause (I) is in
addition to any other authority
to use procedures other than
competitive procedures.
(III) Applicable
government-wide regulations.--
The Secretary shall implement
this clause in accordance with
government-wide regulations
implementing such section
303(c)(1) (including
requirements that offers be
solicited from as many
potential sources as is
practicable under the
circumstances, that required
notices be published, and that
submitted offers be
considered), as such
regulations apply to
procurements for which an
agency has authority to use
procedures other than
competitive procedures when the
property or services needed by
the agency are available from
only one responsible source or
only from a limited number of
responsible sources and no
other type of property or
services will satisfy the needs
of the agency.
(v) Premium provision in multiple
award contracts.--
(I) In general.--If, under
this subsection, the Secretary
enters into contracts with more
than one vendor to procure a
security countermeasure, such
Secretary may, notwithstanding
any other provision of law,
include in each of such
contracts a provision that--
(aa) identifies an
increment of the total
quantity of security
countermeasure
required, whether by
percentage or by
numbers of units; and
(bb) promises to
pay one or more
specified premiums
based on the priority
of such vendors'
production and delivery
of the increment
identified under item
(aa), in accordance
with the terms and
conditions of the
contract.
(II) Determination of
government's requirement not
reviewable.--If the Secretary
includes in each of a set of
contracts a provision as
described in subclause (I),
such Secretary's determination
of the total quantity of
security countermeasure
required, and any amendment of
such determination, is
committed to agency discretion.
(vi) Extension of closing date for
receipt of proposals not reviewable.--A
decision by the Secretary to extend the
closing date for receipt of proposals
for a procurement under this subsection
is committed to agency discretion.
(vii) Limiting competition to
sources responding to request for
information.--In conducting a
procurement under this subsection, the
Secretary may exclude a source that has
not responded to a request for
information under section 303A(a)(1)(B)
of the Federal Property and
Administrative Services Act of 1949 (41
U.S.C. 253a(a)(1)(B)) if such request
has given notice that the Secretary may
so exclude such a source.
(8) Interagency cooperation.--
(A) In general.--In carrying out activities
under this section, the Homeland Security
Secretary and the Secretary are authorized,
subject to subparagraph (B), to enter into
interagency agreements and other collaborative
undertakings with other agencies of the United
States Government. Such agreements may allow
other executive agencies to order qualified and
security countermeasures under procurement
contracts or other agreements established by
the Secretary. Such ordering process (including
transfers of appropriated funds between an
agency and the Department of Health and Human
Services as reimbursements for such orders for
countermeasures) may be conducted under the
authority of section 1535 of title 31, United
States Code, except that all such orders shall
be processed under the terms established under
this subsection for the procurement of
countermeasures.
(B) Limitation.--An agreement or
undertaking under this paragraph shall not
authorize another agency to exercise the
authorities provided by this section to the
Homeland Security Secretary or to the
Secretary.
(9) Restrictions on use of funds.--Amounts in the
special reserve fund under paragraph (10) shall not be
used to pay--
(A) costs for the purchase of vaccines
under procurement contracts entered into before
the date of the enactment of the Project
BioShield Act of 2004; or
(B) costs other than payments made by the
Secretary to a vendor for a procurement of a
security countermeasure under paragraph (7).
(10) Definitions.--
(A) Special reserve fund.--For purposes of
this subsection, the term ``special reserve
fund'' has the meaning given such term in
section 510 of the Homeland Security Act of
2002 \1\.
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\1\ Subsections (a) through (c) of such section provide as follows:
(a) Authorization of Appropriations.--For the procurement of
security countermeasures under section 319F-2(c) of the Public Health
Service Act (referred to in this section as the ``security
countermeasures program''), there is authorized to be appropriated up
to $5,593,000,000 for the fiscal years 2004 through 2013. Of the
amounts appropriated under the preceding sentence, not to exceed
$3,418,000,000 may be obligated during the fiscal years 2004 through
2008, of which not to exceed $890,000,000 may be obligated during
fiscal year 2004.
(b) Special Reserve Fund.--For purposes of the security
countermeasures program, the term ``special reserve fund'' means the
``Biodefense Countermeasures'' appropriations account or any other
appropriation made under subsection (a).
(c) Availability.--Amounts appropriated under subsection (a) become
available for a procurement under the security countermeasures program
only upon the approval by the President of such availability for the
procurement in accordance with paragraph (6)(B) of such program.
---------------------------------------------------------------------------
(B) Designated congressional committees.--
For purposes of this section, the term
``designated congressional committees'' means
the following committees of the Congress:
(i) In the House of
Representatives: the Committee on
Energy and Commerce, the Committee on
Appropriations, the Committee on
Government Reform, and the Select
Committee on Homeland Security (or any
successor to the Select Committee).
(ii) In the Senate: the appropriate
committees.
(d) Disclosures.--No Federal agency shall disclose under
section 552 of title 5, United States Code, any information
identifying the location at which materials in the stockpile
under subsection (a) are stored.
(e) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a);
or
(2) a contractual agreement between the Secretary
and a vendor or vendors under which such vendor or
vendors agree to provide to such Secretary supplies
described in subsection (a).
(f) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose
of carrying out subsection (a), there are authorized to
be appropriated $640,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006. Such authorization is in addition to
amounts in the special reserve fund referred to in
subsection (c)(10)(A).
(2) Smallpox vaccine development.--For the purpose
of carrying out subsection (b), there are authorized to
be appropriated $509,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.
SEC. 319F-3. [247D-6D] TARGETED LIABILITY PROTECTIONS FOR PANDEMIC AND
EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.
(a) Liability Protections.--
(1) In general.--Subject to the other provisions of
this section, a covered person shall be immune from
suit and liability under Federal and State law with
respect to all claims for loss caused by, arising out
of, relating to, or resulting from the administration
to or the use by an individual of a covered
countermeasure if a declaration under subsection (b)
has been issued with respect to such countermeasure.
(2) Scope of claims for loss.--
(A) Loss.--For purposes of this section,
the term ``loss'' means any type of loss,
including--
(i) death;
(ii) physical, mental, or emotional
injury, illness, disability, or
condition;
(iii) fear of physical, mental, or
emotional injury, illness, disability,
or condition, including any need for
medical monitoring; and
(iv) loss of or damage to property,
including business interruption loss.
Each of clauses (i) through (iv) applies
without regard to the date of the occurrence,
presentation, or discovery of the loss
described in the clause.
(B) Scope.--The immunity under paragraph
(1) applies to any claim for loss that has a
causal relationship with the administration to
or use by an individual of a covered
countermeasure, including a causal relationship
with the design, development, clinical testing
or investigation, manufacture, labeling,
distribution, formulation, packaging,
marketing, promotion, sale, purchase, donation,
dispensing, prescribing, administration,
licensing, or use of such countermeasure.
(3) Certain conditions.--Subject to the other
provisions of this section, immunity under paragraph
(1) with respect to a covered countermeasure applies
only if--
(A) the countermeasure was administered or
used during the effective period of the
declaration that was issued under subsection
(b) with respect to the countermeasure;
(B) the countermeasure was administered or
used for the category or categories of
diseases, health conditions, or threats to
health specified in the declaration; and
(C) in addition, in the case of a covered
person who is a program planner or qualified
person with respect to the administration or
use of the countermeasure, the countermeasure
was administered to or used by an individual
who--
(i) was in a population specified
by the declaration; and
(ii) was at the time of
administration physically present in a
geographic area specified by the
declaration or had a connection to such
area specified in the declaration.
(4) Applicability of certain conditions.--With
respect to immunity under paragraph (1) and subject to
the other provisions of this section:
(A) In the case of a covered person who is
a manufacturer or distributor of the covered
countermeasure involved, the immunity applies
without regard to whether such countermeasure
was administered to or used by an individual in
accordance with the conditions described in
paragraph (3)(C).
(B) In the case of a covered person who is
a program planner or qualified person with
respect to the administration or use of the
covered countermeasure, the scope of immunity
includes circumstances in which the
countermeasure was administered to or used by
an individual in circumstances in which the
covered person reasonably could have believed
that the countermeasure was administered or
used in accordance with the conditions
described in paragraph (3)(C).
(5) Effect of distribution method.--The provisions
of this section apply to a covered countermeasure
regardless of whether such countermeasure is obtained
by donation, commercial sale, or any other means of
distribution, except to the extent that, under
paragraph (2)(E) of subsection (b), the declaration
under such subsection provides that subsection (a)
applies only to covered countermeasures obtained
through a particular means of distribution.
(6) Rebuttable presumption.--For purposes of
paragraph (1), there shall be a rebuttable presumption
that any administration or use, during the effective
period of the emergency declaration by the Secretary
under subsection (b), of a covered countermeasure shall
have been for the category or categories of diseases,
health conditions, or threats to health with respect to
which such declaration was issued.
(b) Declaration by Secretary.--
(1) Authority to issue declaration.--Subject to
paragraph (2), if the Secretary makes a determination
that a disease or other health condition or other
threat to health constitutes a public health emergency,
or that there is a credible risk that the disease,
condition, or threat may in the future constitute such
an emergency, the Secretary may make a declaration,
through publication in the Federal Register,
recommending, under conditions as the Secretary may
specify, the manufacture, testing, development,
distribution, administration, or use of one or more
covered countermeasures, and stating that subsection
(a) is in effect with respect to the activities so
recommended.
(2) Contents.--In issuing a declaration under
paragraph (1), the Secretary shall identify, for each
covered countermeasure specified in the declaration--
(A) the category or categories of diseases,
health conditions, or threats to health for
which the Secretary recommends the
administration or use of the countermeasure;
(B) the period or periods during which,
including as modified by paragraph (3),
subsection (a) is in effect, which period or
periods may be designated by dates, or by
milestones or other description of events,
including factors specified in paragraph (6);
(C) the population or populations of
individuals for which subsection (a) is in
effect with respect to the administration or
use of the countermeasure (which may be a
specification that such subsection applies
without geographic limitation to all
individuals);
(D) the geographic area or areas for which
subsection (a) is in effect with respect to the
administration or use of the countermeasure
(which may be a specification that such
subsection applies without geographic
limitation), including, with respect to
individuals in the populations identified under
subparagraph (C), a specification, as
determined appropriate by the Secretary, of
whether the declaration applies only to
individuals physically present in such areas or
whether in addition the declaration applies to
individuals who have a connection to such
areas, which connection is described in the
declaration; and
(E) whether subsection (a) is effective
only to a particular means of distribution as
provided in subsection (a)(5) for obtaining the
countermeasure, and if so, the particular means
to which such subsection is effective.
(3) Effective period of declaration.--
(A) Flexibility of period.--The Secretary
may, in describing periods under paragraph
(2)(B), have different periods for different
covered persons to address different
logistical, practical or other differences in
responsibilities.
(B) Additional time to be specified.--In
each declaration under paragraph (1), the
Secretary, after consulting, to the extent the
Secretary deems appropriate, with the
manufacturer of the covered countermeasure,
shall also specify a date that is after the
ending date specified under paragraph (2)(B)
and that allows what the Secretary determines
is--
(i) a reasonable period for the
manufacturer to arrange for disposition
of the covered countermeasure,
including the return of such product to
the manufacturer; and
(ii) a reasonable period for
covered persons to take such other
actions as may be appropriate to limit
administration or use of the covered
countermeasure.
(C) Additional period for certain strategic
national stockpile countermeasures.--With
respect to a covered countermeasure that is in
the stockpile under section 319F-2, if such
countermeasure was the subject of a declaration
under paragraph (1) at the time that it was
obtained for the stockpile, the effective
period of such declaration shall include a
period when the countermeasure is administered
or used pursuant to a distribution or release
from the stockpile.
(4) Amendments to declaration.--The Secretary may
through publication in the Federal Register amend any
portion of a declaration under paragraph (1). Such an
amendment shall not retroactively limit the
applicability of subsection (a) with respect to the
administration or use of the covered countermeasure
involved.
(5) Certain disclosures.--In publishing a
declaration under paragraph (1) in the Federal
Register, the Secretary is not required to disclose any
matter described in section 552(b) of title 5, United
States Code.
(6) Factors to be considered.--In deciding whether
and under what circumstances or conditions to issue a
declaration under paragraph (1) with respect to a
covered countermeasure, the Secretary shall consider
the desirability of encouraging the design,
development, clinical testing or investigation,
manufacture, labeling, distribution, formulation,
packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration,
licensing, and use of such countermeasure.
(7) Judicial review.--No court of the United
States, or of any State, shall have subject matter
jurisdiction to review, whether by mandamus or
otherwise, any action by the Secretary under this
subsection.
(8) Preemption of state law.--During the effective
period of a declaration under subsection (b), or at any
time with respect to conduct undertaken in accordance
with such declaration, no State or political
subdivision of a State may establish, enforce, or
continue in effect with respect to a covered
countermeasure any provision of law or legal
requirement that--
(A) is different from, or is in conflict
with, any requirement applicable under this
section; and
(B) relates to the design, development,
clinical testing or investigation, formulation,
manufacture, distribution, sale, donation,
purchase, marketing, promotion, packaging,
labeling, licensing, use, any other aspect of
safety or efficacy, or the prescribing,
dispensing, or administration by qualified
persons of the covered countermeasure, or to
any matter included in a requirement applicable
to the covered countermeasure under this
section or any other provision of this Act, or
under the Federal Food, Drug, and Cosmetic Act.
(9) Report to congress.--Within 30 days after
making a declaration under paragraph (1), the Secretary
shall submit to the appropriate committees of the
Congress a report that provides an explanation of the
reasons for issuing the declaration and the reasons
underlying the determinations of the Secretary with
respect to paragraph (2). Within 30 days after making
an amendment under paragraph (4), the Secretary shall
submit to such committees a report that provides the
reasons underlying the determination of the Secretary
to make the amendment.
(c) Definition of Willful Misconduct.--
(1) Definition.--
(A) In general.--Except as the meaning of
such term is further restricted pursuant to
paragraph (2), the term ``willful misconduct''
shall, for purposes of subsection (d), denote
an act or omission that is taken--
(i) intentionally to achieve a
wrongful purpose;
(ii) knowingly without legal or
factual justification; and
(iii) in disregard of a known or
obvious risk that is so great as to
make it highly probable that the harm
will outweigh the benefit.
(B) Rule of construction.--The criterion
stated in subparagraph (A) shall be construed
as establishing a standard for liability that
is more stringent than a standard of negligence
in any form or recklessness.
(2) Authority to promulgate regulatory
definition.--
(A) In general.--The Secretary, in
consultation with the Attorney General, shall
promulgate regulations, which may be
promulgated through interim final rules, that
further restrict the scope of actions or
omissions by a covered person that may qualify
as ``willful misconduct'' for purposes of
subsection (d).
(B) Factors to be considered.--In
promulgating the regulations under this
paragraph, the Secretary, in consultation with
the Attorney General, shall consider the need
to define the scope of permissible civil
actions under subsection (d) in a way that will
not adversely affect the public health.
(C) Temporal scope of regulations.--The
regulations under this paragraph may specify
the temporal effect that they shall be given
for purposes of subsection (d).
(D) Initial rulemaking.--Within 180 days
after the enactment of the Public Readiness and
Emergency Preparedness Act, the Secretary, in
consultation with the Attorney General, shall
commence and complete an initial rulemaking
process under this paragraph.
(3) Proof of willful misconduct.--In an action
under subsection (d), the plaintiff shall have the
burden of proving by clear and convincing evidence
willful misconduct by each covered person sued and that
such willful misconduct caused death or serious
physical injury.
(4) Defense for acts or omissions taken pursuant to
secretary's declaration.--Notwithstanding any other
provision of law, a program planner or qualified person
shall not have engaged in ``willful misconduct'' as a
matter of law where such program planner or qualified
person acted consistent with applicable directions,
guidelines, or recommendations by the Secretary
regarding the administration or use of a covered
countermeasure that is specified in the declaration
under subsection (b), provided either the Secretary, or
a State or local health authority, was provided with
notice of information regarding serious physical injury
or death from the administration or use of a covered
countermeasure that is material to the plaintiff's
alleged loss within 7 days of the actual discovery of
such information by such program planner or qualified
person.
(5) Exclusion for regulated activity of
manufacturer or distributor.--
(A) In general.--If an act or omission by a
manufacturer or distributor with respect to a
covered countermeasure, which act or omission
is alleged under subsection (e)(3)(A) to
constitute willful misconduct, is subject to
regulation by this Act or by the Federal Food,
Drug, and Cosmetic Act, such act or omission
shall not constitute ``willful misconduct'' for
purposes of subsection (d) if--
(i) neither the Secretary nor the
Attorney General has initiated an
enforcement action with respect to such
act or omission; or
(ii) such an enforcement action has
been initiated and the action has been
terminated or finally resolved without
a covered remedy.
Any action or proceeding under subsection (d)
shall be stayed during the pendency of such an
enforcement action.
(B) Definitions.--For purposes of this
paragraph, the following terms have the
following meanings:
(i) Enforcement action.--The term
``enforcement action'' means a criminal
prosecution, an action seeking an
injunction, a seizure action, a civil
monetary proceeding based on willful
misconduct, a mandatory recall of a
product because voluntary recall was
refused, a proceeding to compel repair
or replacement of a product, a
termination of an exemption under
section 505(i) or 520(g) of the Federal
Food, Drug, and Cosmetic Act, a
debarment proceeding, an investigator
disqualification proceeding where an
investigator is an employee or agent of
the manufacturer, a revocation, based
on willful misconduct, of an
authorization under section 564 of such
Act, or a suspension or withdrawal,
based on willful misconduct, of an
approval or clearance under chapter V
of such Act or of a licensure under
section 351 of this Act.
(ii) Covered remedy.--The term
``covered remedy'' means an outcome--
(I) that is a criminal
conviction, an injunction, or a
condemnation, a civil monetary
payment, a product recall, a
repair or replacement of a
product, a termination of an
exemption under section 505(i)
or 520(g) of the Federal Food,
Drug, and Cosmetic Act, a
debarment, an investigator
disqualification, a revocation
of an authorization under
section 564 of such Act, or a
suspension or withdrawal of an
approval or clearance under
chapter 5 of such Act or of a
licensure under section 351 of
this Act; and
(II) that results from a
final determination by a court
or from a final agency action.
(iii) Final.--The terms ``final''
and ``finally''--
(I) with respect to a court
determination, or to a final
resolution of an enforcement
action that is a court
determination, mean a judgment
from which an appeal of right
cannot be taken or a voluntary
or stipulated dismissal; and
(II) with respect to an
agency action, or to a final
resolution of an enforcement
action that is an agency
action, mean an order that is
not subject to further review
within the agency and that has
not been reversed, vacated,
enjoined, or otherwise
nullified by a final court
determination or a voluntary or
stipulated dismissal.
(C) Rules of construction.--
(i) In general.--Nothing in this
paragraph shall be construed--
(I) to affect the
interpretation of any provision
of the Federal Food, Drug, and
Cosmetic Act, of this Act, or
of any other applicable statute
or regulation; or
(II) to impair, delay,
alter, or affect the authority,
including the enforcement
discretion, of the United
States, of the Secretary, of
the Attorney General, or of any
other official with respect to
any administrative or court
proceeding under this Act,
under the Federal Food, Drug,
and Cosmetic Act, under title
18 of the United States Code,
or under any other applicable
statute or regulation.
(ii) Mandatory recalls.--A
mandatory recall called for in the
declaration is not a Food and Drug
Administration enforcement action.
(d) Exception to Immunity of Covered Persons.--
(1) In general.--Subject to subsection (f), the
sole exception to the immunity from suit and liability
of covered persons set forth in subsection (a) shall be
for an exclusive Federal cause of action against a
covered person for death or serious physical injury
proximately caused by willful misconduct, as defined
pursuant to subsection (c), by such covered person. For
purposes of section 2679(b)(2)(B) of title 28, United
States Code, such a cause of action is not an action
brought for violation of a statute of the United States
under which an action against an individual is
otherwise authorized.
(2) Persons who can sue.--An action under this
subsection may be brought for wrongful death or serious
physical injury by any person who suffers such injury
or by any representative of such a person.
(e) Procedures for Suit.--
(1) Exclusive federal jurisdiction.--Any action
under subsection (d) shall be filed and maintained only
in the United States District Court for the District of
Columbia.
(2) Governing law.--The substantive law for
decision in an action under subsection (d) shall be
derived from the law, including choice of law
principles, of the State in which the alleged willful
misconduct occurred, unless such law is inconsistent
with or preempted by Federal law, including provisions
of this section.
(3) Pleading with particularity.--In an action
under subsection (d), the complaint shall plead with
particularity each element of the plaintiff's claim,
including--
(A) each act or omission, by each covered
person sued, that is alleged to constitute
willful misconduct relating to the covered
countermeasure administered to or used by the
person on whose behalf the complaint was filed;
(B) facts supporting the allegation that
such alleged willful misconduct proximately
caused the injury claimed; and
(C) facts supporting the allegation that
the person on whose behalf the complaint was
filed suffered death or serious physical
injury.
(4) Verification, certification, and medical
records.--
(A) In general.--In an action under
subsection (d), the plaintiff shall verify the
complaint in the manner stated in subparagraph
(B) and shall file with the complaint the
materials described in subparagraph (C). A
complaint that does not substantially comply
with subparagraphs (B) and (C) shall not be
accepted for filing and shall not stop the
running of the statute of limitations.
(B) Verification requirement.--
(i) In general.--The complaint
shall include a verification, made by
affidavit of the plaintiff under oath,
stating that the pleading is true to
the knowledge of the deponent, except
as to matters specifically identified
as being alleged on information and
belief, and that as to those matters
the plaintiff believes it to be true.
(ii) Identification of matters
alleged upon information and belief.--
Any matter that is not specifically
identified as being alleged upon the
information and belief of the
plaintiff, shall be regarded for all
purposes, including a criminal
prosecution, as having been made upon
the knowledge of the plaintiff.
(C) Materials required.--In an action under
subsection (d), the plaintiff shall file with
the complaint--
(i) an affidavit, by a physician
who did not treat the person on whose
behalf the complaint was filed,
certifying, and explaining the basis
for such physician's belief, that such
person suffered the serious physical
injury or death alleged in the
complaint and that such injury or death
was proximately caused by the
administration or use of a covered
countermeasure; and
(ii) certified medical records
documenting such injury or death and
such proximate causal connection.
(5) Three-judge court.--Any action under subsection
(d) shall be assigned initially to a panel of three
judges. Such panel shall have jurisdiction over such
action for purposes of considering motions to dismiss,
motions for summary judgment, and matters related
thereto. If such panel has denied such motions, or if
the time for filing such motions has expired, such
panel shall refer the action to the chief judge for
assignment for further proceedings, including any
trial. Section 1253 of title 28, United States Code,
and paragraph (3) of subsection (b) of section 2284 of
title 28, United States Code, shall not apply to
actions under subsection (d).
(6) Civil discovery.--
(A) Timing.--In an action under subsection
(d), no discovery shall be allowed--
(i) before each covered person sued
has had a reasonable opportunity to
file a motion to dismiss;
(ii) in the event such a motion is
filed, before the court has ruled on
such motion; and
(iii) in the event a covered person
files an interlocutory appeal from the
denial of such a motion, before the
court of appeals has ruled on such
appeal.
(B) Standard.--Notwithstanding any other
provision of law, the court in an action under
subsection (d) shall permit discovery only with
respect to matters directly related to material
issues contested in such action, and the court
shall compel a response to a discovery request
(including a request for admission, an
interrogatory, a request for production of
documents, or any other form of discovery
request) under Rule 37, Federal Rules of Civil
Procedure, only if the court finds that the
requesting party needs the information sought
to prove or defend as to a material issue
contested in such action and that the likely
benefits of a response to such request equal or
exceed the burden or cost for the responding
party of providing such response.
(7) Reduction in award of damages for collateral
source benefits.--
(A) In general.--In an action under
subsection (d), the amount of an award of
damages that would otherwise be made to a
plaintiff shall be reduced by the amount of
collateral source benefits to such plaintiff.
(B) Provider of collateral source benefits
not to have lien or subrogation.--No provider
of collateral source benefits shall recover any
amount against the plaintiff or receive any
lien or credit against the plaintiff's recovery
or be equitably or legally subrogated to the
right of the plaintiff in an action under
subsection (d).
(C) Collateral source benefit defined.--For
purposes of this paragraph, the term
``collateral source benefit'' means any amount
paid or to be paid in the future to or on
behalf of the plaintiff, or any service,
product, or other benefit provided or to be
provided in the future to or on behalf of the
plaintiff, as a result of the injury or
wrongful death, pursuant to--
(i) any State or Federal health,
sickness, income-disability, accident,
or workers' compensation law;
(ii) any health, sickness, income-
disability, or accident insurance that
provides health benefits or income-
disability coverage;
(iii) any contract or agreement of
any group, organization, partnership,
or corporation to provide, pay for, or
reimburse the cost of medical,
hospital, dental, or income disability
benefits; or
(iv) any other publicly or
privately funded program.
(8) Noneconomic damages.--In an action under
subsection (d), any noneconomic damages may be awarded
only in an amount directly proportional to the
percentage of responsibility of a defendant for the
harm to the plaintiff. For purposes of this paragraph,
the term ``noneconomic damages'' means damages for
losses for physical and emotional pain, suffering,
inconvenience, physical impairment, mental anguish,
disfigurement, loss of enjoyment of life, loss of
society and companionship, loss of consortium, hedonic
damages, injury to reputation, and any other
nonpecuniary losses.
(9) Rule 11 sanctions.--Whenever a district court
of the United States determines that there has been a
violation of Rule 11 of the Federal Rules of Civil
Procedure in an action under subsection (d), the court
shall impose upon the attorney, law firm, or parties
that have violated Rule 11 or are responsible for the
violation, an appropriate sanction, which may include
an order to pay the other party or parties for the
reasonable expenses incurred as a direct result of the
filing of the pleading, motion, or other paper that is
the subject of the violation, including a reasonable
attorney's fee. Such sanction shall be sufficient to
deter repetition of such conduct or comparable conduct
by others similarly situated, and to compensate the
party or parties injured by such conduct.
(10) Interlocutory appeal.--The United States Court
of Appeals for the District of Columbia Circuit shall
have jurisdiction of an interlocutory appeal by a
covered person taken within 30 days of an order denying
a motion to dismiss or a motion for summary judgment
based on an assertion of the immunity from suit
conferred by subsection (a) or based on an assertion of
the exclusion under subsection (c)(5).
(f) Actions by and Against the United States.--Nothing in
this section shall be construed to abrogate or limit any right,
remedy, or authority that the United States or any agency
thereof may possess under any other provision of law or to
waive sovereign immunity or to abrogate or limit any defense or
protection available to the United States or its agencies,
instrumentalities, officers, or employees under any other law,
including any provision of chapter 171 of title 28, United
States Code (relating to tort claims procedure).
(g) Severability.--If any provision of this section, or the
application of such provision to any person or circumstance, is
held to be unconstitutional, the remainder of this section and
the application of such remainder to any person or circumstance
shall not be affected thereby.
(h) Rule of Construction Concerning National Vaccine Injury
Compensation Program.--Nothing in this section, or any
amendment made by the Public Readiness and Emergency
Preparedness Act, shall be construed to affect the National
Vaccine Injury Compensation Program under title XXI of this
Act.
(i) Definitions.--In this section:
(1) Covered countermeasure.--The term ``covered
countermeasure'' means--
(A) a qualified pandemic or epidemic
product (as defined in paragraph (7));
(B) a security countermeasure (as defined
in section 319F-2(c)(1)(B)); or
(C) a drug (as such term is defined in
section 201(g)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g)(1)),
biological product (as such term is defined by
section 351(i) of this Act), or device (as such
term is defined by section 201(h) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C.
321(h)) that is authorized for emergency use in
accordance with section 564 of the Federal
Food, Drug, and Cosmetic Act.
(2) Covered person.--The term ``covered person'',
when used with respect to the administration or use of
a covered countermeasure, means--
(A) the United States; or
(B) a person or entity that is--
(i) a manufacturer of such
countermeasure;
(ii) a distributor of such
countermeasure;
(iii) a program planner of such
countermeasure;
(iv) a qualified person who
prescribed, administered, or dispensed
such countermeasure; or
(v) an official, agent, or employee
of a person or entity described in
clause (i), (ii), (iii), or (iv).
(3) Distributor.--The term ``distributor'' means a
person or entity engaged in the distribution of drugs,
biologics, or devices, including but not limited to
manufacturers; repackers; common carriers; contract
carriers; air carriers; own-label distributors;
private-label distributors; jobbers; brokers;
warehouses, and wholesale drug warehouses; independent
wholesale drug traders; and retail pharmacies.
(4) Manufacturer.--The term ``manufacturer''
includes--
(A) a contractor or subcontractor of a
manufacturer;
(B) a supplier or licenser of any product,
intellectual property, service, research tool,
or component or other article used in the
design, development, clinical testing,
investigation, or manufacturing of a covered
countermeasure; and
(C) any or all of the parents,
subsidiaries, affiliates, successors, and
assigns of a manufacturer.
(5) Person.--The term ``person'' includes an
individual, partnership, corporation, association,
entity, or public or private corporation, including a
Federal, State, or local government agency or
department.
(6) Program planner.--The term ``program planner''
means a State or local government, including an Indian
tribe, a person employed by the State or local
government, or other person who supervised or
administered a program with respect to the
administration, dispensing, distribution, provision, or
use of a security countermeasure or a qualified
pandemic or epidemic product, including a person who
has established requirements, provided policy guidance,
or supplied technical or scientific advice or
assistance or provides a facility to administer or use
a covered countermeasure in accordance with a
declaration under subsection (b).
(7) Qualified pandemic or epidemic product.--The
term ``qualified pandemic or epidemic product'' means a
drug (as such term is defined in section 201(g)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)), biological product (as such term is defined
by section 351(i) of this Act), or device (as such term
is defined by section 201(h) of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 321(h)) that is--
(A)(i) a product manufactured, used,
designed, developed, modified, licensed, or
procured--
(I) to diagnose, mitigate, prevent,
treat, or cure a pandemic or epidemic;
or
(II) to limit the harm such
pandemic or epidemic might otherwise
cause; or
(ii) a product manufactured, used,
designed, developed, modified, licensed, or
procured to diagnose, mitigate, prevent, treat,
or cure a serious or life-threatening disease
or condition caused by a product described in
clause (i); and
(B)(i) approved or cleared under chapter V
of the Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of this Act;
(ii) the object of research for possible
use as described by subparagraph (A) and is the
subject of an exemption under section 505(i) or
520(g) of the Federal Food, Drug, and Cosmetic
Act; or
(iii) authorized for emergency use in
accordance with section 564 of the Federal
Food, Drug, and Cosmetic Act.
(8) Qualified person.--The term ``qualified
person'', when used with respect to the administration
or use of a covered countermeasure, means--
(A) a licensed health professional or other
individual who is authorized to prescribe,
administer, or dispense such countermeasures
under the law of the State in which the
countermeasure was prescribed, administered, or
dispensed; or
(B) a person within a category of persons
so identified in a declaration by the Secretary
under subsection (b).
(9) Security countermeasure.--The term ``security
countermeasure'' has the meaning given such term in
section 319F-2(c)(1)(B).
(10) Serious physical injury.--The term ``serious
physical injury'' means an injury that--
(A) is life threatening;
(B) results in permanent impairment of a
body function or permanent damage to a body
structure; or
(C) necessitates medical or surgical
intervention to preclude permanent impairment
of a body function or permanent damage to a
body structure.
SEC. 319F-4. [247D-6E] COVERED COUNTERMEASURE PROCESS.
(a) Establishment of Fund.--Upon the issuance by the
Secretary of a declaration under section 319F-3(b), there is
hereby established in the Treasury an emergency fund designated
as the ``Covered Countermeasure Process Fund'' for purposes of
providing timely, uniform, and adequate compensation to
eligible individuals for covered injuries directly caused by
the administration or use of a covered countermeasure pursuant
to such declaration, which Fund shall consist of such amounts
designated as emergency appropriations under section 402 of H.
Con. Res. 95 of the 109th Congress, this emergency designation
shall remain in effect through October 1, 2006.
(b) Payment of Compensation.--
(1) In general.--If the Secretary issues a
declaration under 319F-3(b), the Secretary shall, after
amounts have by law been provided for the Fund under
subsection (a), provide compensation to an eligible
individual for a covered injury directly caused by the
administration or use of a covered countermeasure
pursuant to such declaration.
(2) Elements of compensation.--The compensation
that shall be provided pursuant to paragraph (1) shall
have the same elements, and be in the same amount, as
is prescribed by sections 264, 265, and 266 in the case
of certain individuals injured as a result of
administration of certain countermeasures against
smallpox, except that section 266(a)(2)(B) shall not
apply.
(3) Rule of construction.--Neither reasonable and
necessary medical benefits nor lifetime total benefits
for lost employment income due to permanent and total
disability shall be limited by section 266.
(4) Determination of eligibility and
compensation.--Except as provided in this section, the
procedures for determining, and for reviewing a
determination of, whether an individual is an eligible
individual, whether such individual has sustained a
covered injury, whether compensation may be available
under this section, and the amount of such compensation
shall be those stated in section 262 (other than in
subsection (d)(2) of such section), in regulations
issued pursuant to that section, and in such additional
or alternate regulations as the Secretary may
promulgate for purposes of this section. In making
determinations under this section, other than those
described in paragraph (5)(A) as to the direct
causation of a covered injury, the Secretary may only
make such determination based on compelling, reliable,
valid, medical and scientific evidence.
(5) Covered countermeasure injury table.--
(A) In general.--The Secretary shall by
regulation establish a table identifying
covered injuries that shall be presumed to be
directly caused by the administration or use of
a covered countermeasure and the time period in
which the first symptom or manifestation of
onset of each such adverse effect must manifest
in order for such presumption to apply. The
Secretary may only identify such covered
injuries, for purpose of inclusion on the
table, where the Secretary determines, based on
compelling, reliable, valid, medical and
scientific evidence that administration or use
of the covered countermeasure directly caused
such covered injury.
(B) Amendments.--The provisions of section
263 (other than a provision of subsection
(a)(2) of such section that relates to
accidental vaccinia inoculation) shall apply to
the table established under this section.
(C) Judicial review.--No court of the
United States, or of any State, shall have
subject matter jurisdiction to review, whether
by mandamus or otherwise, any action by the
Secretary under this paragraph.
(6) Meanings of terms.--In applying sections 262,
263, 264, 265, and 266 for purposes of this section--
(A) the terms ``vaccine'' and ``smallpox
vaccine'' shall be deemed to mean a covered
countermeasure;
(B) the terms ``smallpox vaccine injury
table'' and ``table established under section
263'' shall be deemed to refer to the table
established under paragraph (4); and
(C) other terms used in those sections
shall have the meanings given to such terms by
this section.
(c) Voluntary Program.--The Secretary shall ensure that a
State, local, or Department of Health and Human Services plan
to administer or use a covered countermeasure is consistent
with any declaration under 319F-3 and any applicable guidelines
of the Centers for Disease Control and Prevention and that
potential participants are educated with respect to
contraindications, the voluntary nature of the program, and the
availability of potential benefits and compensation under this
part.
(d) Exhaustion; Exclusivity; Election.--
(1) Exhaustion.--Subject to paragraph (5), a
covered individual may not bring a civil action under
section 319F-3(d) against a covered person (as such
term is defined in section 319F-3(i)(2)) unless such
individual has exhausted such remedies as are available
under subsection (a), except that if amounts have not
by law been provided for the Fund under subsection (a),
or if the Secretary fails to make a final determination
on a request for benefits or compensation filed in
accordance with the requirements of this section within
240 days after such request was filed, the individual
may seek any remedy that may be available under section
319F-3(d).
(2) Tolling of statute of limitations.--The time
limit for filing a civil action under section 319F-3(d)
for an injury or death shall be tolled during the
pendency of a claim for compensation under subsection
(a).
(3) Rule of construction.--This section shall not
be construed as superseding or otherwise affecting the
application of a requirement, under chapter 171 of
title 28, United States Code, to exhaust administrative
remedies.
(4) Exclusivity.--The remedy provided by subsection
(a) shall be exclusive of any other civil action or
proceeding for any claim or suit this section
encompasses, except for a proceeding under section
319F-3.
(5) Election.--If under subsection (a) the
Secretary determines that a covered individual
qualifies for compensation, the individual has an
election to accept the compensation or to bring an
action under section 319F-3(d). If such individual
elects to accept the compensation, the individual may
not bring such an action.
(e) Definitions.--For purposes of this section, the
following terms shall have the following meanings:
(1) Covered countermeasure.--The term ``covered
countermeasure'' has the meaning given such term in
section 319F-3.
(2) Covered individual.--The term ``covered
individual'', with respect to administration or use of
a covered countermeasure pursuant to a declaration,
means an individual--
(A) who is in a population specified in
such declaration, and with respect to whom the
administration or use of the covered
countermeasure satisfies the other
specifications of such declaration; or
(B) who uses the covered countermeasure, or
to whom the covered countermeasure is
administered, in a good faith belief that the
individual is in the category described by
subparagraph (A).
(3) Covered injury.--The term ``covered injury''
means serious physical injury or death.
(4) Declaration.--The term ``declaration'' means a
declaration under section 319F-3(b).
(5) Eligible individual.--The term ``eligible
individual'' means an individual who is determined, in
accordance with subsection (b), to be a covered
individual who sustains a covered injury.
SEC. 319G. [247D-7] DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM
TRAINING, COORDINATION, AND READINESS.
(a) In General.--The Secretary shall make grants to not
more than three eligible entities to carry out demonstration
programs to improve the detection of pathogens likely to be
used in a bioterrorist attack, the development of plans and
measures to respond to bioterrorist attacks, and the training
of personnel involved with the various responsibilities and
capabilities needed to respond to acts of bioterrorism upon the
civilian population. Such awards shall be made on a competitive
basis and pursuant to scientific and technical review.
(b) Eligible Entities.--Eligible entities for grants under
subsection (a) are States, political subdivisions of States,
and public or private non-profit organizations.
(c) Specific Criteria.--In making grants under subsection
(a), the Secretary shall take into account the following
factors:
(1) Whether the eligible entity involved is
proximate to, and collaborates with, a major research
university with expertise in scientific training,
identification of biological agents, medicine, and life
sciences.
(2) Whether the entity is proximate to, and
collaborates with, a laboratory that has expertise in
the identification of biological agents.
(3) Whether the entity demonstrates, in the
application for the program, support and participation
of State and local governments and research
institutions in the conduct of the program.
(4) Whether the entity is proximate to, and
collaborates with, or is, an academic medical center
that has the capacity to serve an uninsured or
underserved population, and is equipped to educate
medical personnel.
(5) Such other factors as the Secretary determines
to be appropriate.
(d) Duration of Award.--The period during which payments
are made under a grant under subsection (a) may not exceed 5
years. The provision of such payments shall be subject to
annual approval by the Secretary of the payments and subject to
the availability of appropriations for the fiscal year involved
to make the payments.
(e) Supplement Not Supplant.--Grants under subsection (a)
shall be used to supplement, and not supplant, other Federal,
State, or local public funds provided for the activities
described in such subsection.
(f ) General Accounting Office Report \1\.--Not later than
180 days after the conclusion of the demonstration programs
carried out under subsection (a), the Comptroller General of
the United States shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate, and the Committee on Commerce and
the Committee on Appropriations of the House of
Representatives, a report that describes the ability of
grantees under such subsection to detect pathogens likely to be
used in a bioterrorist attack, develop plans and measures for
dealing with such threats, and train personnel involved with
the various responsibilities and capabilities needed to deal
with bioterrorist threats.
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\1\ Now the Government Accountability Office. See section 8 of
Public Law 108-271 (118 Stat. 814).
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(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $6,000,000 for
fiscal year 2001, and such sums as may be necessary through
fiscal year 2006.
SEC. 319H. [247D-7A] GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN
HEALTH PROFESSIONALS.
(a) In General.--The Secretary may make awards of grants
and cooperative agreements to appropriate public and nonprofit
private health or educational entities, including health
professions schools and programs as defined in section 799B,
for the purpose of providing low-interest loans, partial
scholarships, partial fellowships, revolving loan funds, or
other cost-sharing forms of assistance for the education and
training of individuals in any category of health professions
for which there is a shortage that the Secretary determines
should be alleviated in order to prepare for or respond
effectively to bioterrorism and other public health
emergencies.
(b) Authority Regarding Non-Federal Contributions.--The
Secretary may require as a condition of an award under
subsection (a) that a grantee under such subsection provide
non-Federal contributions toward the purpose described in such
subsection.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.
SEC. 319I. [247D-7B] EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF
HEALTH PROFESSIONS VOLUNTEERS.
(a) In General.--Not later than 12 months after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary shall link existing State verification systems to
maintain a single national interoperable network of systems,
each system being maintained by a State or group of States, for
the purpose of verifying the credentials and licenses of health
care professionals who volunteer to provide health services
during a public health emergency.
(b) Requirements.--The interoperable network of systems
established under subsection (a) (referred to in this section
as the ``verification network'') shall include--
(1) with respect to each volunteer health
professional included in the verification network--
(A) information necessary for the rapid
identification of, and communication with, such
professionals; and
(B) the credentials, certifications,
licenses, and relevant training of such
individuals; and
(2) the name of each member of the Medical Reserve
Corps, the National Disaster Medical System, and any
other relevant federally-sponsored or administered
programs determined necessary by the Secretary.
(c) Other Assistance.--The Secretary may make grants and
provide technical assistance to States and other public or
nonprofit private entities for activities relating to the
verification network developed under subsection (a).
(d) Accessibility.--The Secretary shall ensure that the
verification network is electronically accessible by State,
local, and tribal health departments and can be linked with the
identification cards under section 2813.
(e) Confidentiality.--The Secretary shall establish and
require the application of and compliance with measures to
ensure the effective security of, integrity of, and access to
the data included in the verification network.
(f) Coordination.--The Secretary shall coordinate with the
Secretary of Veterans Affairs and the Secretary of Homeland
Security to assess the feasibility of integrating the
verification network under this section with the VetPro system
of the Department of Veterans Affairs and the National
Emergency Responder Credentialing System of the Department of
Homeland Security. The Secretary shall, if feasible, integrate
the verification network under this section with such VetPro
system and the National Emergency Responder Credentialing
System.
(g) Updating of Information.--The States that are
participants in the verification network shall, on at least a
quarterly basis, work with the Director to provide for the
updating of the information contained in the verification
network.
(h) Clarification.--Inclusion of a health professional in
the verification network shall not constitute appointment of
such individual as a Federal employee for any purpose, either
under section 2812(c) or otherwise. Such appointment may only
be made under section 2812 or 2813.
(i) Health Care Provider Licenses.--The Secretary shall
encourage States to establish and implement mechanisms to waive
the application of licensing requirements applicable to health
professionals, who are seeking to provide medical services
(within their scope of practice), during a national, State,
local, or tribal public health emergency upon verification that
such health professionals are licensed and in good standing in
another State and have not been disciplined by any State health
licensing or disciplinary board.
(j) Rule of Construction.--This section may not be
construed as authorizing the Secretary to issue requirements
regarding the provision by the States of credentials, licenses,
accreditations, or hospital privileges.
(k) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums as
may be necessary for each of the fiscal years 2003 through
2011.
SEC. 319J. [247D-7C] SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
(a) In General.--Upon the request of a recipient of an
award under any of sections 319 through 319I or section 319K,
the Secretary may, subject to subsection (b), provide supplies,
equipment, and services for the purpose of aiding the recipient
in carrying out the purposes for which the award is made and,
for such purposes, may detail to the recipient any officer or
employee of the Department of Health and Human Services.
(b) Corresponding Reduction in Payments.--With respect to a
request described in subsection (a), the Secretary shall reduce
the amount of payments under the award involved by an amount
equal to the costs of detailing personnel and the fair market
value of any supplies, equipment, or services provided by the
Secretary. The Secretary shall, for the payment of expenses
incurred in complying with such request, expend the amounts
withheld.
SEC. 319K. [247D-7D] SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
(a) In General.--The Secretary, in consultation with the
Attorney General and the Secretary of Defense, may provide
technical or other assistance to provide security to persons or
facilities that conduct development, production, distribution,
or storage of priority countermeasures (as defined in section
319F(h)(4)).
(b) Guidelines.--The Secretary may develop guidelines to
enable entities eligible to receive assistance under subsection
(a) to secure their facilities against potential terrorist
attack.
SEC. 319L. [247D-7E] BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.
(a) Definitions.--In this section:
(1) BARDA.--The term ``BARDA'' means the Biomedical
Advanced Research and Development Authority.
(2) Fund.--The term ``Fund'' means the Biodefense
Medical Countermeasure Development Fund established
under subsection (d).
(3) Other transactions.--The term ``other
transactions'' means transactions, other than
procurement contracts, grants, and cooperative
agreements, such as the Secretary of Defense may enter
into under section 2371 of title 10, United States
Code.
(4) Qualified countermeasure.--The term ``qualified
countermeasure'' has the meaning given such term in
section 319F-1.
(5) Qualified pandemic or epidemic product.--The
term ``qualified pandemic or epidemic product'' has the
meaning given the term in section 319F-3.
(6) Advanced research and development.--
(A) In general.--The term ``advanced
research and development'' means, with respect
to a product that is or may become a qualified
countermeasure or a qualified pandemic or
epidemic product, activities that
predominantly--
(i) are conducted after basic
research and preclinical development of
the product; and
(ii) are related to manufacturing
the product on a commercial scale and
in a form that satisfies the regulatory
requirements under the Federal Food,
Drug, and Cosmetic Act or under section
351 of this Act.
(B) Activities included.--The term under
subparagraph (A) includes--
(i) testing of the product to
determine whether the product may be
approved, cleared, or licensed under
the Federal Food, Drug, and Cosmetic
Act or under section 351 of this Act
for a use that is or may be the basis
for such product becoming a qualified
countermeasure or qualified pandemic or
epidemic product, or to help obtain
such approval, clearance, or license;
(ii) design and development of
tests or models, including animal
models, for such testing;
(iii) activities to facilitate
manufacture of the product on a
commercial scale with consistently high
quality, as well as to improve and make
available new technologies to increase
manufacturing surge capacity;
(iv) activities to improve the
shelf-life of the product or
technologies for administering the
product; and
(v) such other activities as are
part of the advanced stages of testing,
refinement, improvement, or preparation
of the product for such use and as are
specified by the Secretary.
(7) Security countermeasure.--The term ``security
countermeasure'' has the meaning given such term in
section 319F-2.
(8) Research tool.--The term ``research tool''
means a device, technology, biological material
(including a cell line or an antibody), reagent, animal
model, computer system, computer software, or
analytical technique that is developed to assist in the
discovery, development, or manufacture of qualified
countermeasures or qualified pandemic or epidemic
products.
(9) Program manager.--The term ``program manager''
means an individual appointed to carry out functions
under this section and authorized to provide project
oversight and management of strategic initiatives.
(10) Person.--The term ``person'' includes an
individual, partnership, corporation, association,
entity, or public or private corporation, and a
Federal, State, or local government agency or
department.
(b) Strategic Plan for Countermeasure Research,
Development, and Procurement.--
(1) In general.--Not later than 6 months after the
date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall develop and make
public a strategic plan to integrate biodefense and
emerging infectious disease requirements with the
advanced research and development, strategic
initiatives for innovation, and the procurement of
qualified countermeasures and qualified pandemic or
epidemic products. The Secretary shall carry out such
activities as may be practicable to disseminate the
information contained in such plan to persons who may
have the capacity to substantially contribute to the
activities described in such strategic plan. The
Secretary shall update and incorporate such plan as
part of the National Health Security Strategy described
in section 2802.
(2) Content.--The strategic plan under paragraph
(1) shall guide--
(A) research and development, conducted or
supported by the Department of Health and Human
Services, of qualified countermeasures and
qualified pandemic or epidemic products against
possible biological, chemical, radiological,
and nuclear agents and to emerging infectious
diseases;
(B) innovation in technologies that may
assist advanced research and development of
qualified countermeasures and qualified
pandemic or epidemic products (such research
and development referred to in this section as
``countermeasure and product advanced research
and development''); and
(C) procurement of such qualified
countermeasures and qualified pandemic or
epidemic products by such Department.
(c) Biomedical Advanced Research and Development
Authority.--
(1) Establishment.--There is established within the
Department of Health and Human Services the Biomedical
Advanced Research and Development Authority.
(2) In general.--Based upon the strategic plan
described in subsection (b), the Secretary shall
coordinate the acceleration of countermeasure and
product advanced research and development by--
(A) facilitating collaboration between the
Department of Health and Human Services and
other Federal agencies, relevant industries,
academia, and other persons, with respect to
such advanced research and development;
(B) promoting countermeasure and product
advanced research and development;
(C) facilitating contacts between
interested persons and the offices or employees
authorized by the Secretary to advise such
persons regarding requirements under the
Federal Food, Drug, and Cosmetic Act and under
section 351 of this Act; and
(D) promoting innovation to reduce the time
and cost of countermeasure and product advanced
research and development.
(3) Director.--The BARDA shall be headed by a
Director (referred to in this section as the
``Director'') who shall be appointed by the Secretary
and to whom the Secretary shall delegate such functions
and authorities as necessary to implement this section.
(4) Duties.--
(A) Collaboration.--To carry out the
purpose described in paragraph (2)(A), the
Secretary shall--
(i) facilitate and increase the
expeditious and direct communication
between the Department of Health and
Human Services and relevant persons
with respect to countermeasure and
product advanced research and
development, including by--
(I) facilitating such
communication regarding the
processes for procuring such
advanced research and
development with respect to
qualified countermeasures and
qualified pandemic or epidemic
products of interest; and
(II) soliciting information
about and data from research on
potential qualified
countermeasures and qualified
pandemic or epidemic products
and related technologies;
(ii) at least annually--
(I) convene meetings with
representatives from relevant
industries, academia, other
Federal agencies, international
agencies as appropriate, and
other interested persons;
(II) sponsor opportunities
to demonstrate the operation
and effectiveness of relevant
biodefense countermeasure
technologies; and
(III) convene such working
groups on countermeasure and
product advanced research and
development as the Secretary
may determine are necessary to
carry out this section; and
(iii) carry out the activities
described in section 405 of the
Pandemic and All-Hazards Preparedness
Act.
(B) Support advanced research and
development.--To carry out the purpose
described in paragraph (2)(B), the Secretary
shall--
(i) conduct ongoing searches for,
and support calls for, potential
qualified countermeasures and qualified
pandemic or epidemic products;
(ii) direct and coordinate the
countermeasure and product advanced
research and development activities of
the Department of Health and Human
Services;
(iii) establish strategic
initiatives to accelerate
countermeasure and product advanced
research and development and innovation
in such areas as the Secretary may
identify as priority unmet need areas;
and
(iv) award contracts, grants,
cooperative agreements, and enter into
other transactions, for countermeasure
and product advanced research and
development.
(C) Facilitating advice.--To carry out the
purpose described in paragraph (2)(C) the
Secretary shall--
(i) connect interested persons with
the offices or employees authorized by
the Secretary to advise such persons
regarding the regulatory requirements
under the Federal Food, Drug, and
Cosmetic Act and under section 351 of
this Act related to the approval,
clearance, or licensure of qualified
countermeasures or qualified pandemic
or epidemic products; and
(ii) with respect to persons
performing countermeasure and product
advanced research and development
funded under this section, enable such
offices or employees to provide to the
extent practicable such advice in a
manner that is ongoing and that is
otherwise designed to facilitate
expeditious development of qualified
countermeasures and qualified pandemic
or epidemic products that may achieve
such approval, clearance, or licensure.
(D) Supporting innovation.--To carry out
the purpose described in paragraph (2)(D), the
Secretary may award contracts, grants, and
cooperative agreements, or enter into other
transactions, such as prize payments, to
promote--
(i) innovation in technologies that
may assist countermeasure and product
advanced research and development;
(ii) research on and development of
research tools and other devices and
technologies; and
(iii) research to promote strategic
initiatives, such as rapid diagnostics,
broad spectrum antimicrobials, and
vaccine manufacturing technologies.
(5) Transaction authorities.--
(A) Other transactions.--
(i) In general.--The Secretary
shall have the authority to enter into
other transactions under this
subsection in the same manner as the
Secretary of Defense enters into such
transactions under section 2371 of
title 10, United States Code.
(ii) Limitations on authority.--
(I) In general.--
Subsections (b), (c), and (h)
of section 845 of the National
Defense Authorization Act for
Fiscal Year 1994 (10 U.S.C.
2371 note) shall apply to other
transactions under this
subparagraph as if such
transactions were for prototype
projects described by
subsection (a) of such section
845.
(II) Written determinations
required.--The authority of
this subparagraph may be
exercised for a project that is
expected to cost the Department
of Health and Human Services in
excess of $20,000,000 only upon
a written determination by the
senior procurement executive
for the Department (as
designated for purpose of
section 16(c) of the Office of
Federal Procurement Policy Act
(41 U.S.C. 414(c))), that the
use of such authority is
essential to promoting the
success of the project. The
authority of the senior
procurement executive under
this subclause may not be
delegated.
(iii) Guidelines.--The Secretary
shall establish guidelines regarding
the use of the authority under clause
(i). Such guidelines shall include
auditing requirements.
(B) Expedited authorities.--
(i) In general.--In awarding
contracts, grants, and cooperative
agreements, and in entering into other
transactions under subparagraph (B) or
(D) of paragraph (4), the Secretary
shall have the expedited procurement
authorities, the authority to expedite
peer review, and the authority for
personal services contracts, supplied
by subsections (b), (c), and (d) of
section 319F-1.
(ii) Application of provisions.--
Provisions in such section 319F-1 that
apply to such authorities and that
require institution of internal
controls, limit review, provide for
Federal Tort Claims Act coverage of
personal services contractors, and
commit decisions to the discretion of
the Secretary shall apply to the
authorities as exercised pursuant to
this paragraph.
(iii) Authority to limit
competition.--For purposes of applying
section 319F-1(b)(1)(D) to this
paragraph, the phrase ``BioShield
Program under the Project BioShield Act
of 2004'' shall be deemed to mean the
countermeasure and product advanced
research and development program under
this section.
(iv) Availability of data.--The
Secretary shall require that, as a
condition of being awarded a contract,
grant, cooperative agreement, or other
transaction under subparagraph (B) or
(D) of paragraph (4), a person make
available to the Secretary on an
ongoing basis, and submit upon request
to the Secretary, all data related to
or resulting from countermeasure and
product advanced research and
development carried out pursuant to
this section.
(C) Advance payments; advertising.--The
Secretary may waive the requirements of section
3324(a) of title 31, United States Code, or
section 3709 of the Revised Statutes of the
United States (41 U.S.C. 5) upon the
determination by the Secretary that such waiver
is necessary to obtain countermeasures or
products under this section.
(D) Milestone-based payments allowed.--In
awarding contracts, grants, and cooperative
agreements, and in entering into other
transactions, under this section, the Secretary
may use milestone-based awards and payments.
(E) Foreign nationals eligible.--The
Secretary may under this section award
contracts, grants, and cooperative agreements
to, and may enter into other transactions with,
highly qualified foreign national persons
outside the United States, alone or in
collaboration with American participants, when
such transactions may inure to the benefit of
the American people.
(F) Establishment of research centers.--The
Secretary may assess the feasibility and
appropriateness of establishing, through
contract, grant, cooperative agreement, or
other transaction, an arrangement with an
existing research center in order to achieve
the goals of this section. If such an agreement
is not feasible and appropriate, the Secretary
may establish one or more federally-funded
research and development centers, or
university-affiliated research centers, in
accordance with section 303(c)(3) of the
Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(3)).
(6) At-risk individuals.--In carrying out the
functions under this section, the Secretary may give
priority to the advanced research and development of
qualified countermeasures and qualified pandemic or
epidemic products that are likely to be safe and
effective with respect to children, pregnant women,
elderly, and other at-risk individuals.
(7) Personnel authorities.--
(A) Specially qualified scientific and
professional personnel.--
(i) In general.--In addition to any
other personnel authorities, the
Secretary may--
(I) without regard to those
provisions of title 5, United
States Code, governing
appointments in the competitive
service, appoint highly
qualified individuals to
scientific or professional
positions in BARDA, such as
program managers, to carry out
this section; and
(II) compensate them in the
same manner and subject to the
same terms and conditions in
which individuals appointed
under section 9903 of such
title are compensated, without
regard to the provisions of
chapter 51 and subchapter III
of chapter 53 of such title
relating to classification and
General Schedule pay rates.
(ii) Manner of exercise of
authority.--The authority provided for
in this subparagraph shall be exercised
subject to the same limitations
described in section 319F-1(e)(2).
(iii) Term of appointment.--The
term limitations described in section
9903(c) of title 5, United States Code,
shall apply to appointments under this
subparagraph, except that the
references to the ``Secretary'' and to
the ``Department of Defense's national
security missions'' shall be deemed to
be to the Secretary of Health and Human
Services and to the mission of the
Department of Health and Human Services
under this section.
(B) Special consultants.--In carrying out
this section, the Secretary may appoint special
consultants pursuant to section 207(f).
(C) Limitation.--
(i) In general.--The Secretary may
hire up to 100 highly qualified
individuals, or up to 50 percent of the
total number of employees, whichever is
less, under the authorities provided
for in subparagraphs (A) and (B).
(ii) Report.--The Secretary shall
report to Congress on a biennial basis
on the implementation of this
subparagraph.
(d) Fund.--
(1) Establishment.--There is established the
Biodefense Medical Countermeasure Development Fund,
which shall be available to carry out this section in
addition to such amounts as are otherwise available for
this purpose.
(2) Funding.--To carry out the purposes of this
section, there are authorized to be appropriated to the
Fund--
(A) $1,070,000,000 for fiscal years 2006
through 2008, the amounts to remain available
until expended; and
(B) such sums as may be necessary for
subsequent fiscal years, the amounts to remain
available until expended.
(e) Inapplicability of Certain Provisions.--
(1) Disclosure.--
(A) In general.--The Secretary shall
withhold from disclosure under section 552 of
title 5, United States Code, specific technical
data or scientific information that is created
or obtained during the countermeasure and
product advanced research and development
carried out under subsection (c) that reveals
significant and not otherwise publicly known
vulnerabilities of existing medical or public
health defenses against biological, chemical,
nuclear, or radiological threats. Such
information shall be deemed to be information
described in section 552(b)(3) of title 5,
United States Code.
(B) Review.--Information subject to
nondisclosure under subparagraph (A) shall be
reviewed by the Secretary every 5 years, or
more frequently as determined necessary by the
Secretary, to determine the relevance or
necessity of continued nondisclosure.
(C) Sunset.--This paragraph shall cease to
have force or effect on the date that is 7
years after the date of enactment of the
Pandemic and All-Hazards Preparedness Act.
(2) Review.--Notwithstanding section 14 of the
Federal Advisory Committee Act, a working group of
BARDA under this section and the National Biodefense
Science Board under section 319M shall each terminate
on the date that is 5 years after the date on which
each such group or Board, as applicable, was
established. Such 5-year period may be extended by the
Secretary for one or more additional 5-year periods if
the Secretary determines that any such extension is
appropriate.
SEC. 319M. [247D-F] NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING
GROUPS.
(a) In General.--
(1) Establishment and function.--The Secretary
shall establish the National Biodefense Science Board
(referred to in this section as the ``Board'') to
provide expert advice and guidance to the Secretary on
scientific, technical and other matters of special
interest to the Department of Health and Human Services
regarding current and future chemical, biological,
nuclear, and radiological agents, whether naturally
occurring, accidental, or deliberate.
(2) Membership.--The membership of the Board shall
be comprised of individuals who represent the Nation's
preeminent scientific, public health, and medical
experts, as follows--
(A) such Federal officials as the Secretary
may determine are necessary to support the
functions of the Board;
(B) four individuals representing the
pharmaceutical, biotechnology, and device
industries;
(C) four individuals representing academia;
and
(D) five other members as determined
appropriate by the Secretary, of whom--
(i) one such member shall be a
practicing healthcare professional; and
(ii) one such member shall be an
individual from an organization
representing healthcare consumers.
(3) Term of appointment.--A member of the Board
described in subparagraph (B), (C), or (D) of paragraph
(2) shall serve for a term of 3 years, except that the
Secretary may adjust the terms of the initial Board
appointees in order to provide for a staggered term of
appointment for all members.
(4) Consecutive appointments; maximum terms.--A
member may be appointed to serve not more than 3 terms
on the Board and may serve not more than 2 consecutive
terms.
(5) Duties.--The Board shall--
(A) advise the Secretary on current and
future trends, challenges, and opportunities
presented by advances in biological and life
sciences, biotechnology, and genetic
engineering with respect to threats posed by
naturally occurring infectious diseases and
chemical, biological, radiological, and nuclear
agents;
(B) at the request of the Secretary, review
and consider any information and findings
received from the working groups established
under subsection (b); and
(C) at the request of the Secretary,
provide recommendations and findings for
expanded, intensified, and coordinated
biodefense research and development activities.
(6) Meetings.--
(A) Initial meeting.--Not later than one
year after the date of enactment of the
Pandemic and All-Hazards Preparedness Act, the
Secretary shall hold the first meeting of the
Board.
(B) Subsequent meetings.--The Board shall
meet at the call of the Secretary, but in no
case less than twice annually.
(7) Vacancies.--Any vacancy in the Board shall not
affect its powers, but shall be filled in the same
manner as the original appointment.
(8) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
(9) Powers.--
(A) Hearings.--The Board may hold such
hearings, sit and act at such times and places,
take such testimony, and receive such evidence
as the Board considers advisable to carry out
this subsection.
(B) Postal services.--The Board may use the
United States mails in the same manner and
under the same conditions as other departments
and agencies of the Federal Government.
(10) Personnel.--
(A) Employees of the federal government.--A
member of the Board that is an employee of the
Federal Government may not receive additional
pay, allowances, or benefits by reason of the
member's service on the Board.
(B) Other members.--A member of the Board
that is not an employee of the Federal
Government may be compensated at a rate not to
exceed the daily equivalent of the annual rate
of basic pay prescribed for level IV of the
Executive Schedule under section 5315 of title
5, United States Code, for each day (including
travel time) during which the member is engaged
in the actual performance of duties as a member
of the Board.
(C) Travel expenses.--Each member of the
Board shall receive travel expenses, including
per diem in lieu of subsistence, in accordance
with applicable provisions under subchapter I
of chapter 57 of title 5, United States Code.
(D) Detail of government employees.--Any
Federal Government employee may be detailed to
the Board with the approval for the
contributing agency without reimbursement, and
such detail shall be without interruption or
loss of civil service status or privilege.
(b) Other Working Groups.--The Secretary may establish a
working group of experts, or may use an existing working group
or advisory committee, to--
(1) identify innovative research with the potential
to be developed as a qualified countermeasure or a
qualified pandemic or epidemic product;
(2) identify accepted animal models for particular
diseases and conditions associated with any biological,
chemical, radiological, or nuclear agent, any toxin, or
any potential pandemic infectious disease, and identify
strategies to accelerate animal model and research tool
development and validation; and
(3) obtain advice regarding supporting and
facilitating advanced research and development related
to qualified countermeasures and qualified pandemic or
epidemic products that are likely to be safe and
effective with respect to children, pregnant women, and
other vulnerable populations, and other issues
regarding activities under this section that affect
such populations.
(c) Definitions.--Any term that is defined in section 319L
and that is used in this section shall have the same meaning in
this section as such term is given in section 319L.
(d) Authorization of Appropriations.--There are authorized
to be appropriated $1,000,000 to carry out this section for
fiscal year 2007 and each fiscal year thereafter.
hansen's disease program
Sec. 320. [247e] (a)(1) At or through the National Hansen's
Disease Programs Center (located in the State of Louisiana),
the Secretary shall without charge provide short-term care and
treatment, including outpatient care, for Hansen's disease and
related complications to any person determined by the Secretary
to be in need of such care and treatment. The Secretary may not
at or through such Center provide long-term care for any such
disease or complication.
(2) The Center referred to in paragraph (1) shall conduct
training in the diagnosis and management of Hansen's disease
and related complications, and shall conduct and promote the
coordination of research (including clinical research),
investigations, demonstrations, and studies relating to the
causes, diagnosis, treatment, control, and prevention of
Hansen's disease and other mycobacterial diseases and
complications related to such diseases.
(3) Paragraph (1) is subject to section 211 of the
Department of Health and Human Services Appropriations Act,
1998. \1\
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\1\ Title II of Public Law 105-78. See 111 Stat. 1477, 1489.
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(b) In addition to the Center referred to in subsection
(a), the Secretary may establish sites regarding persons with
Hansen's disease. Each such site shall provide for the
outpatient care and treatment for Hansen's disease and related
complications to any person determined by the Secretary to be
in need of such care and treatment.
(c) The Secretary shall carry out subsections (a) and (b)
acting through an agency of the Service. For purposes of the
preceding sentence, the agency designated by the Secretary
shall carry out both activities relating to the provision of
health services and activities relating to the conduct of
research.
(d) The Secretary shall make payments to the Board of
Health of the State of Hawaii for the care and treatment
(including outpatient care) in its facilities of persons
suffering from Hansen's disease at a rate determined by the
Secretary. The rate shall be approximately equal to the
operating cost per patient of such facilities, except that the
rate may not exceed the comparable costs per patient with
Hansen's disease for care and treatment provided by the Center
referred to in subsection (a). Payments under this subsection
are subject to the availability of appropriations for such
purpose.
coordinated program to improve pediatric oral health
Sec. 320A. \2\ [247d-8] (a) In General.--The Secretary,
acting through the Administrator of the Health Resources and
Services Administration, shall establish a program to fund
innovative oral health activities that improve the oral health
of children under 6 years of age who are eligible for services
provided under a Federal health program, to increase the
utilization of dental services by such children, and to
decrease the incidence of early childhood and baby bottle tooth
decay.
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\2\ The placement of this section in title III was carried out to
reflect the probable intent of Congress. Section 1603 of Public Law
106-310 (114 Stat. 1151) provided for an amendment to ``Part B of the
Public Health Service Act'', without specifying which title of this Act
was the subject of the amendment.
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(b) Grants.--The Secretary shall award grants to or enter
into contracts with public or private nonprofit schools of
dentistry or accredited dental training institutions or
programs, community dental programs, and programs operated by
the Indian Health Service (including federally recognized
Indian tribes that receive medical services from the Indian
Health Service, urban Indian health programs funded under title
V of the Indian Health Care Improvement Act, and tribes that
contract with the Indian Health Service pursuant to the Indian
Self-Determination and Education Assistance Act) to enable such
schools, institutions, and programs to develop programs of oral
health promotion, to increase training of oral health services
providers in accordance with State practice laws, or to
increase the utilization of dental services by eligible
children.
(c) Distribution.--In awarding grants under this section,
the Secretary shall, to the extent practicable, ensure an
equitable national geographic distribution of the grants,
including areas of the United States where the incidence of
early childhood caries is highest.
(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $10,000,000 for
each the fiscal years 2001 through 2005.
Part C--Hospitals, Medical Examinations, and Medical Care
hospitals
Sec. 321. [248] The Surgeon General, pursuant to
regulations, shall--
(a) Control, manage, and operate all institutions,
hospitals, and stations of the Service, including minor
repairs and maintenance, and provide for the care,
treatment, and hospitalization of patients, including
the furnishing of prosthetic and orthopedic devices;
and from time to time with the approval of the
President, select suitable sites for and establish such
additional institutions, hospitals, and stations in the
States and possessions of the United States as in his
judgment are necessary to enable the Service to
discharge its functions and duties;
(b) Provide for the transfer of Public Health
Service patients, in the care of attendants where
necessary, between hospitals and stations operated by
the Service or between such hospitals and stations and
other hospitals and stations in which Public Health
Service patients may be received, and the payment of
expenses of such transfer;
(c) Provide for the disposal of articles produced
by patients in the course of their curative treatment,
either by allowing the patient to retain such articles
or by selling them and depositing the money received
therefor to the credit of the appropriation from which
the materials for making the articles were purchased;
(d) Provide for the disposal of money and effects,
in the custody of the hospitals or stations, of
deceased patients; and
(e) Provide, to the extent the Surgeon General
determines that other public or private funds are not
available therefor, for the payment of expenses of
preparing and transporting the remains of, or the
payment of reasonable burial expenses for, any patient
dying in a hospital or station.
care and treatment of persons under quarantine and certain other
persons
Sec. 322. [249] (a) Any person when detained in accordance
with quarantine laws, or, at the request of the Immigration and
Naturalization Service, any person detained by that Service,
may be treated and cared for by the Public Health Service.
(b) Persons not entitled to treatment and care at
institutions, hospitals, and stations of the Service may, in
accordance with regulations of the Surgeon General, be admitted
thereto for temporary treatment and care in case of emergency.
(c) Persons whose care and treatment is authorized by
subsection (a) may, in accordance with regulations, receive
such care and treatment at the expense of the Service from
public or private medical or hospital facilities other than
those of the Service, when authorized by the officer in charge
of the station at which the application is made.
care and treatment of federal prisoners \1\
Sec. 323. [250] The Service shall supervise and furnish
medical treatment and other necessary medical, psychiatric, and
related technical and scientific services, authorized by the
Act of May 13, 1930, as amended (U.S.C., 1940 edition, title
18, secs. 751, 752), \2\ in penal and correctional institutions
of the United States.
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\1\ Title I of the Departments of Commerce, Justice, and State, the
Judiciary, and Related Agencies Appropriations Act, 2005 (as contained
in division B of Public Law 108-447) provided that of the amounts
appropriated for salaries and expenses regarding the Federal Prison
System ``the Attorney General may transfer to the Health Resources and
Services Administration such amounts as may be necessary for direct
expenditures by that Administration for medical relief for inmates of
Federal penal and correctional institutions''. (See 118 Stat. 2860.)
Similar provisions have appeared in the analogous appropriations Act of
many prior years. See section 250a of title 42, United States Code, and
the notes following such section.
\2\ Now codified to section 4005 of title 18, United States Code.
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examination and treatment of federal employees
Sec. 324. [251] (a) The Surgeon General is authorized to
provide at institutions, hospitals, and stations of the Service
medical, surgical, and hospital services and supplies for
persons entitled to treatment under the United States
Employees' Compensation Act \3\ and extensions thereof. The
Surgeon General may also provide for making medical
examinations of--
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\3\ Codified to chapter 81 of title 5, United States Code.
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(1) employees of the Federal Government for
retirement purposes;
(2) employees in Federal classified service, and
applicants for appointment, as requested by the Civil
Service Commission for the purpose of promoting health
and efficiency;
(3) seamen for purposes of qualifying for
certificates of service; and
(4) employees eligible for benefits under the
Longshoremen's and Harbor Workers' Compensation Act, as
amended (U.S.C. 1940 edition, title 33, chapter 18),
\4\ as requested by any deputy commissioner thereunder.
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\4\ Codification remains chapter 18 of title 33, United States
Code.
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(b) The Secretary is authorized to provide medical,
surgical, and dental treatment and hospitalization and
optometric care for Federal employees (as defined in section
8901(1) of title 5 of the United States Code) and their
dependents at remote medical facilities of the Public Health
Service where such care and treatment are not otherwise
available. Such employees and their dependents who are not
entitled to this care and treatment under any other provision
of law shall be charged for it at rates established by the
Secretary to reflect the reasonable cost of providing the care
and treatment. Any payments pursuant to the preceding sentence
shall be credited to the applicable appropriation to the Public
Health Service for the year in which such payments are
received.
examination of aliens
Sec. 325. [252] The Surgeon General shall provide for
making, at places within the United States or in other
countries, such physical and mental examinations of aliens as
are required by the immigration laws, subject to administrative
regulations prescribed by the Attorney General and medical
regulations prescribed by the Surgeon General with the approval
of the Secretary.
services to coast guard, coast and geodetic survey, and public health
service
Sec. 326. [253] (a) Subject to regulations of the
President--
(1) commissioned officers, chief warrant officers,
warrant officers, cadets, and enlisted personnel of the
Regular Coast Guard on active duty, including those on
shore duty and those on detached duty; and Regular and
temporary members of the United States Coast Guard
Reserve when on active duty;
(2) commissioned officers, ships' officers, and
members of the crews of vessels of the United States
Coast and Geodetic Survey on active duty including
those on shore duty and those on detached duty; and
(3) commissioned officers of the Regular or Reserve
Corps of the Public Health Service on active duty;
shall be entitled to medical, surgical, and dental treatment
and hospitalization by the Service. The Surgeon General may
detail commissioned officers for duty aboard vessels of the
Coast Guard or the Coast and Geodetic Survey.
(b)(1) The Secretary may provide health care for an
officer of the Regular or Reserve Corps involuntarily separated
from the Service, and for any dependent of such officer, if--
(A) the officer or dependent was receiving health
care at the expense of the Service at the time of the
separation; and
(B) the Secretary finds that the officer or
dependent is unable to obtain appropriate insurance for
the conditions for which the officer or dependent was
receiving health care.
(2) Health care may be provided under paragraph (1) for a
period of not more than one year from the date of separation of
the officer from the Service.
(c) The Service shall provide all services referred to in
subsection (a) required by the Coast Guard or Coast and
Geodetic Survey and shall perform all duties prescribed by
statute in connection with the examinations to determine
physical or mental condition for purposes of appointment,
enlistment, and reenlistment, promotion and retirement, and
officers of the Service assigned to duty on Coast Guard or
Coast and Geodetic Survey vessels may extend aid to the crews
of American vessels engaged in deep-sea fishing.
interdepartmental work
Sec. 327. [254] Nothing contained in this part shall affect
the authority of the Service to furnish any materials,
supplies, or equipment, or perform any work or services,
requested in accordance with section 7 of the Act of May 21,
1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or
the authority of any other executive department to furnish any
materials, supplies, or equipment, or perform any work or
services, requested by the Department of Health, Education, and
Welfare for the Service in accordance with that section.
sharing of medical care facilities and resources
Sec. 327A. [254a] (a) For purposes of this section--
(1) the term ``specialized health resources'' means
health care resources (whether equipment, space, or
personnel) which, because of cost, limited
availability, or unusual nature, are either unique in
the health care community or are subject to maximum
utilization only through mutual use;
(2) the term ``hospital'', unless otherwise
specified, includes (in addition to other hospitals)
any Federal hospital.
(b) For the purpose of maintaining or improving the quality
of care in Public Health Service facilities and to provide a
professional environment therein which will help to attract and
retain highly qualified and talented health personnel, to
encourage mutually beneficial relationships between Public
Health Service facilities and hospitals and other health
facilities in the health care community, and to promote the
full utilization of hospitals and other health facilities and
resources, the Secretary may--
(1) enter into agreements or arrangements with
schools of medicine, schools of osteopathic medicine,
and with other health professions schools, agencies, or
institutions, for such interchange or cooperative use
of facilities and services on a reciprocal or
reimbursable basis, as will be of benefit to the
training or research programs of the participating
agencies; and
(2) enter into agreement or arrangements with
hospitals and other health care facilities for the
mutual use or the exchange of use of specialized health
resources, and providing for reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement
shall be based on charges covering the reasonable cost of such
utilization, including normal depreciation and amortization
costs of equipment. Any proceeds to the Government under this
subsection shall be credited to the applicable appropriation of
the Public Health Service for the year in which such proceeds
are received.
Part D--Primary Health Care
Subpart I--Health Centers
SEC. 330. [254B] HEALTH CENTERS.
(a) Definition of Health Center.--
(1) In general.--For purposes of this section, the
term ``health center'' means an entity that serves a
population that is medically underserved, or a special
medically underserved population comprised of migratory
and seasonal agricultural workers, the homeless, and
residents of public housing, by providing, either
through the staff and supporting resources of the
center or through contracts or cooperative
arrangements--
(A) required primary health services (as
defined in subsection (b)(1)); and
(B) as may be appropriate for particular
centers, additional health services (as defined
in subsection (b)(2)) necessary for the
adequate support of the primary health services
required under subparagraph (A);
for all residents of the area served by the center
(hereafter referred to in this section as the
``catchment area'').
(2) Limitation.--The requirement in paragraph (1)
to provide services for all residents within a
catchment area shall not apply in the case of a health
center receiving a grant only under subsection (g),
(h), or (i).
(b) Definitions.--For purposes of this section:
(1) Required primary health services.--
(A) In general.--The term ``required
primary health services'' means--
(i) basic health services which,
for purposes of this section, shall
consist of--
(I) health services related
to family medicine, internal
medicine, pediatrics,
obstetrics, or gynecology that
are furnished by physicians and
where appropriate, physician
assistants, nurse
practitioners, and nurse
midwives;
(II) diagnostic laboratory
and radiologic services;
(III) preventive health
services, including--
(aa) prenatal and
perinatal services;
(bb) appropriate
cancer screening;
(cc) well-child
services;
(dd) immunizations
against vaccine-
preventable diseases;
(ee) screenings for
elevated blood lead
levels, communicable
diseases, and
cholesterol;
(ff) pediatric eye,
ear, and dental
screenings to determine
the need for vision and
hearing correction and
dental care;
(gg) voluntary
family planning
services; and
(hh) preventive
dental services;
(IV) emergency medical
services; and
(V) pharmaceutical services
as may be appropriate for
particular centers;
(ii) referrals to providers of
medical services (including specialty
referral when medically indicated) and
other health-related services
(including substance abuse and mental
health services);
(iii) patient case management
services (including counseling,
referral, and follow-up services) and
other services designed to assist
health center patients in establishing
eligibility for and gaining access to
Federal, State, and local programs that
provide or financially support the
provision of medical, social, housing,
educational, or other related services;
(iv) services that enable
individuals to use the services of the
health center (including outreach and
transportation services and, if a
substantial number of the individuals
in the population served by a center
are of limited English-speaking
ability, the services of appropriate
personnel fluent in the language spoken
by a predominant number of such
individuals); and
(v) education of patients and the
general population served by the health
center regarding the availability and
proper use of health services.
(B) Exception.--With respect to a health
center that receives a grant only under
subsection (g), the Secretary, upon a showing
of good cause, shall--
(i) waive the requirement that the
center provide all required primary
health services under this paragraph;
and
(ii) approve, as appropriate, the
provision of certain required primary
health services only during certain
periods of the year.
(2) Additional health services.--The term
``additional health services'' means services that are
not included as required primary health services and
that are appropriate to meet the health needs of the
population served by the health center involved. Such
term may include--
(A) behavioral and mental health and
substance abuse services;
(B) recuperative care services;
(C) environmental health services,
including--
(i) the detection and alleviation
of unhealthful conditions associated
with--
(I) water supply;
(II) chemical and pesticide
exposures;
(III) air quality; or
(IV) exposure to lead;
(ii) sewage treatment;
(iii) solid waste disposal;
(iv) rodent and parasitic
infestation;
(v) field sanitation;
(vi) housing; and
(vii) other environmental factors
related to health; and
(D) in the case of health centers receiving
grants under subsection (g), special
occupation-related health services for
migratory and seasonal agricultural workers,
including--
(i) screening for and control of
infectious diseases, including
parasitic diseases; and
(ii) injury prevention programs,
including prevention of exposure to
unsafe levels of agricultural chemicals
including pesticides.
(3) Medically underserved populations.--
(A) In general.--The term ``medically
underserved population'' means the population
of an urban or rural area designated by the
Secretary as an area with a shortage of
personal health services or a population group
designated by the Secretary as having a
shortage of such services.
(B) Criteria.--In carrying out subparagraph
(A), the Secretary shall prescribe criteria for
determining the specific shortages of personal
health services of an area or population group.
Such criteria shall--
(i) take into account comments
received by the Secretary from the
chief executive officer of a State and
local officials in a State; and
(ii) include factors indicative of
the health status of a population group
or residents of an area, the ability of
the residents of an area or of a
population group to pay for health
services and their accessibility to
them, and the availability of health
professionals to residents of an area
or to a population group.
(C) Limitation.--The Secretary may not
designate a medically underserved population in
a State or terminate the designation of such a
population unless, prior to such designation or
termination, the Secretary provides reasonable
notice and opportunity for comment and consults
with--
(i) the chief executive officer of
such State;
(ii) local officials in such State;
and
(iii) the organization, if any,
which represents a majority of health
centers in such State.
(D) Permissible designation.--The Secretary
may designate a medically underserved
population that does not meet the criteria
established under subparagraph (B) if the chief
executive officer of the State in which such
population is located and local officials of
such State recommend the designation of such
population based on unusual local conditions
which are a barrier to access to or the
availability of personal health services.
(c) Planning Grants.--
(1) In general.--
(A) Centers.--The Secretary may make grants
to public and nonprofit private entities for
projects to plan and develop health centers
which will serve medically underserved
populations. A project for which a grant may be
made under this subsection may include the cost
of the acquisition and lease of buildings and
equipment (including the costs of amortizing
the principal of, and paying the interest on,
loans) and shall include--
(i) an assessment of the need that
the population proposed to be served by
the health center for which the project
is undertaken has for required primary
health services and additional health
services;
(ii) the design of a health center
program for such population based on
such assessment;
(iii) efforts to secure, within the
proposed catchment area of such center,
financial and professional assistance
and support for the project;
(iv) initiation and encouragement
of continuing community involvement in
the development and operation of the
project; and
(v) proposed linkages between the
center and other appropriate provider
entities, such as health departments,
local hospitals, and rural health
clinics, to provide better coordinated,
higher quality, and more cost-effective
health care services.
(B) Managed care networks and plans.--The
Secretary may make grants to health centers
that receive assistance under this section to
enable the centers to plan and develop a
managed care network or plan. Such a grant may
only be made for such a center if--
(i) the center has received grants
under subsection (e)(1)(A) for at least
2 consecutive years preceding the year
of the grant under this subparagraph or
has otherwise demonstrated, as required
by the Secretary, that such center has
been providing primary care services
for at least the 2 consecutive years
immediately preceding such year; and
(ii) the center provides assurances
satisfactory to the Secretary that the
provision of such services on a prepaid
basis, or under another managed care
arrangement, will not result in the
diminution of the level or quality of
health services provided to the
medically underserved population served
prior to the grant under this
subparagraph.
(C) Practice management networks.--The
Secretary may make grants to health centers
that receive assistance under this section to
enable the centers to plan and develop practice
management networks that will enable the
centers to--
(i) reduce costs associated with
the provision of health care services;
(ii) improve access to, and
availability of, health care services
provided to individuals served by the
centers;
(iii) enhance the quality and
coordination of health care services;
or
(iv) improve the health status of
communities.
(D) Use of funds.--The activities for which
a grant may be made under subparagraph (B) or
(C) may include the purchase or lease of
equipment, which may include data and
information systems (including paying for the
costs of amortizing the principal of, and
paying the interest on, loans for equipment),
the provision of training and technical
assistance related to the provision of health
care services on a prepaid basis or under
another managed care arrangement, and other
activities that promote the development of
practice management or managed care networks
and plans.
(2) Limitation.--Not more than two grants may be
made under this subsection for the same project, except
that upon a showing of good cause, the Secretary may
make additional grant awards.
(3) Recognition of high poverty.--
(A) In general.--In making grants under
this subsection, the Secretary may recognize
the unique needs of high poverty areas.
(B) High poverty area defined.--For
purposes of subparagraph (A), the term ``high
poverty area'' means a catchment area which is
established in a manner that is consistent with
the factors in subsection (k)(3)(J), and the
poverty rate of which is greater than the
national average poverty rate as determined by
the Bureau of the Census.
(d) Loan Guarantee Program.--
(1) Establishment.--
(A) In general.--The Secretary shall
establish a program under which the Secretary
may, in accordance with this subsection and to
the extent that appropriations are provided in
advance for such program, guarantee up to 90
percent of the principal and interest on loans
made by non-Federal lenders to health centers,
funded under this section, for the costs of
developing and operating managed care networks
or plans described in subsection (c)(1)(B), or
practice management networks described in
subsection (c)(1)(C).
(B) Use of funds.--Loan funds guaranteed
under this subsection may be used--
(i) to establish reserves for the
furnishing of services on a pre-paid
basis;
(ii) for costs incurred by the
center or centers, otherwise permitted
under this section, as the Secretary
determines are necessary to enable a
center or centers to develop, operate,
and own the network or plan; or
(iii) to refinance an existing loan
(as of the date of refinancing) to the
center or centers, if the Secretary
determines--
(I) that such refinancing
will be beneficial to the
health center and the Federal
Government; or
(II) that the center (or
centers) can demonstrate an
ability to repay the refinanced
loan equal to or greater than
the ability of the center (or
centers) to repay the original
loan on the date the original
loan was made.
(C) Publication of guidance.--Prior to
considering an application submitted under this
subsection, the Secretary shall publish
guidelines to provide guidance on the
implementation of this section. The Secretary
shall make such guidelines available to the
universe of parties affected under this
subsection, distribute such guidelines to such
parties upon the request of such parties, and
provide a copy of such guidelines to the
appropriate committees of Congress.
(D) Provision directly to networks or
plans.--At the request of health centers
receiving assistance under this section, loan
guarantees provided under this paragraph may be
made directly to networks or plans that are at
least majority controlled and, as applicable,
at least majority owned by those health
centers.
(E) Federal credit reform.--The
requirements of the Federal Credit Reform Act
of 1990 (2 U.S.C. 661 et seq.) shall apply with
respect to loans refinanced under subparagraph
(B)(iii).
(2) Protection of financial interests.--
(A) In general.--The Secretary may not
approve a loan guarantee for a project under
this subsection unless the Secretary determines
that--
(i) the terms, conditions, security
(if any), and schedule and amount of
repayments with respect to the loan are
sufficient to protect the financial
interests of the United States and are
otherwise reasonable, including a
determination that the rate of interest
does not exceed such percent per annum
on the principal obligation outstanding
as the Secretary determines to be
reasonable, taking into account the
range of interest rates prevailing in
the private market for similar loans
and the risks assumed by the United
States, except that the Secretary may
not require as security any center
asset that is, or may be, needed by the
center or centers involved to provide
health services;
(ii) the loan would not be
available on reasonable terms and
conditions without the guarantee under
this subsection; and
(iii) amounts appropriated for the
program under this subsection are
sufficient to provide loan guarantees
under this subsection.
(B) Recovery of payments.--
(i) In general.--The United States
shall be entitled to recover from the
applicant for a loan guarantee under
this subsection the amount of any
payment made pursuant to such
guarantee, unless the Secretary for
good cause waives such right of
recovery (subject to appropriations
remaining available to permit such a
waiver) and, upon making any such
payment, the United States shall be
subrogated to all of the rights of the
recipient of the payments with respect
to which the guarantee was made.
Amounts recovered under this clause
shall be credited as reimbursements to
the financing account of the program.
(ii) Modification of terms and
conditions.--To the extent permitted by
clause (iii) and subject to the
requirements of section 504(e) of the
Credit Reform Act of 1990 (2 U.S.C.
661c(e)), any terms and conditions
applicable to a loan guarantee under
this subsection (including terms and
conditions imposed under clause (iv))
may be modified or waived by the
Secretary to the extent the Secretary
determines it to be consistent with the
financial interest of the United
States.
(iii) Incontestability.--Any loan
guarantee made by the Secretary under
this subsection shall be
incontestable--
(I) in the hands of an
applicant on whose behalf such
guarantee is made unless the
applicant engaged in fraud or
misrepresentation in securing
such guarantee; and
(II) as to any person (or
successor in interest) who
makes or contracts to make a
loan to such applicant in
reliance thereon unless such
person (or successor in
interest) engaged in fraud or
misrepresentation in making or
contracting to make such loan.
(iv) Further terms and
conditions.--Guarantees of loans under
this subsection shall be subject to
such further terms and conditions as
the Secretary determines to be
necessary to assure that the purposes
of this section will be achieved.
(3) Loan origination fees.--
(A) In general.--The Secretary shall
collect a loan origination fee with respect to
loans to be guaranteed under this subsection,
except as provided in subparagraph (C).
(B) Amount.--The amount of a loan
origination fee collected by the Secretary
under subparagraph (A) shall be equal to the
estimated long term cost of the loan guarantees
involved to the Federal Government (excluding
administrative costs), calculated on a net
present value basis, after taking into account
any appropriations that may be made for the
purpose of offsetting such costs, and in
accordance with the criteria used to award loan
guarantees under this subsection.
(C) Waiver.--The Secretary may waive the
loan origination fee for a health center
applicant who demonstrates to the Secretary
that the applicant will be unable to meet the
conditions of the loan if the applicant incurs
the additional cost of the fee.
(4) Defaults.--
(A) In general.--Subject to the
requirements of the Credit Reform Act of 1990
(2 U.S.C. 661 et seq.), the Secretary may take
such action as may be necessary to prevent a
default on a loan guaranteed under this
subsection, including the waiver of regulatory
conditions, deferral of loan payments,
renegotiation of loans, and the expenditure of
funds for technical and consultative
assistance, for the temporary payment of the
interest and principal on such a loan, and for
other purposes. Any such expenditure made under
the preceding sentence on behalf of a health
center or centers shall be made under such
terms and conditions as the Secretary shall
prescribe, including the implementation of such
organizational, operational, and financial
reforms as the Secretary determines are
appropriate and the disclosure of such
financial or other information as the Secretary
may require to determine the extent of the
implementation of such reforms.
(B) Foreclosure.--The Secretary may take
such action, consistent with State law
respecting foreclosure procedures and, with
respect to reserves required for furnishing
services on a prepaid basis, subject to the
consent of the affected States, as the
Secretary determines appropriate to protect the
interest of the United States in the event of a
default on a loan guaranteed under this
subsection, except that the Secretary may only
foreclose on assets offered as security (if
any) in accordance with paragraph (2)(A)(i).
(5) Limitation.--Not more than one loan guarantee
may be made under this subsection for the same network
or plan, except that upon a showing of good cause the
Secretary may make additional loan guarantees.
(6) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection such sums as may be necessary.
(e) Operating Grants.--
(1) Authority.--
(A) In general.--The Secretary may make
grants for the costs of the operation of public
and nonprofit private health centers that
provide health services to medically
underserved populations.
(B) Entities that fail to meet certain
requirements.--The Secretary may make grants,
for a period of not to exceed 2 years, for the
costs of the operation of public and nonprofit
private entities which provide health services
to medically underserved populations but with
respect to which the Secretary is unable to
make each of the determinations required by
subsection (k)(3).
(C) Operation of networks and plans.--The
Secretary may make grants to health centers
that receive assistance under this section, or
at the request of the health centers, directly
to a network or plan (as described in
subparagraphs (B) and (C) of subsection (c)(1))
that is at least majority controlled and, as
applicable, at least majority owned by such
health centers receiving assistance under this
section, for the costs associated with the
operation of such network or plan, including
the purchase or lease of equipment (including
the costs of amortizing the principal of, and
paying the interest on, loans for equipment).
(2) Use of funds.--The costs for which a grant may
be made under subparagraph (A) or (B) of paragraph (1)
may include the costs of acquiring and leasing
buildings and equipment (including the costs of
amortizing the principal of, and paying interest on,
loans), and the costs of providing training related to
the provision of required primary health services and
additional health services and to the management of
health center programs.
(3) Construction.--The Secretary may award grants
which may be used to pay the costs associated with
expanding and modernizing existing buildings or
constructing new buildings (including the costs of
amortizing the principal of, and paying the interest
on, loans) for projects approved prior to October 1,
1996.
(4) Limitation.--Not more than two grants may be
made under subparagraph (B) of paragraph (1) for the
same entity.
(5) Amount.--
(A) In general.--The amount of any grant
made in any fiscal year under subparagraphs (A)
and (B) of paragraph (1) to a health center
shall be determined by the Secretary, but may
not exceed the amount by which the costs of
operation of the center in such fiscal year
exceed the total of--
(i) State, local, and other
operational funding provided to the
center; and
(ii) the fees, premiums, and third-
party reimbursements, which the center
may reasonably be expected to receive
for its operations in such fiscal year.
(B) Networks and plans.--The total amount
of grant funds made available for any fiscal
year under paragraph (1)(C) and subparagraphs
(B) and (C) of subsection (c)(1) to a health
center or to a network or plan shall be
determined by the Secretary, but may not exceed
2 percent of the total amount appropriated
under this section for such fiscal year.
(C) Payments.--Payments under grants under
subparagraph (A) or (B) of paragraph (1) shall
be made in advance or by way of reimbursement
and in such installments as the Secretary finds
necessary and adjustments may be made for
overpayments or underpayments.
(D) Use of nongrant funds.--Nongrant funds
described in clauses (i) and (ii) of
subparagraph (A), including any such funds in
excess of those originally expected, shall be
used as permitted under this section, and may
be used for such other purposes as are not
specifically prohibited under this section if
such use furthers the objectives of the
project.
(f) Infant Mortality Grants.--
(1) In general.--The Secretary may make grants to
health centers for the purpose of assisting such
centers in--
(A) providing comprehensive health care and
support services for the reduction of--
(i) the incidence of infant
mortality; and
(ii) morbidity among children who
are less than 3 years of age; and
(B) developing and coordinating service and
referral arrangements between health centers
and other entities for the health management of
pregnant women and children described in
subparagraph (A).
(2) Priority.--In making grants under this
subsection the Secretary shall give priority to health
centers providing services to any medically underserved
population among which there is a substantial incidence
of infant mortality or among which there is a
significant increase in the incidence of infant
mortality.
(3) Requirements.--The Secretary may make a grant
under this subsection only if the health center
involved agrees that--
(A) the center will coordinate the
provision of services under the grant to each
of the recipients of the services;
(B) such services will be continuous for
each such recipient;
(C) the center will provide follow-up
services for individuals who are referred by
the center for services described in paragraph
(1);
(D) the grant will be expended to
supplement, and not supplant, the expenditures
of the center for primary health services
(including prenatal care) with respect to the
purpose described in this subsection; and
(E) the center will coordinate the
provision of services with other maternal and
child health providers operating in the
catchment area.
(g) Migratory and Seasonal Agricultural Workers.--
(1) In general.--The Secretary may award grants for
the purposes described in subsections (c), (e), and (f)
for the planning and delivery of services to a special
medically underserved population comprised of--
(A) migratory agricultural workers,
seasonal agricultural workers, and members of
the families of such migratory and seasonal
agricultural workers who are within a
designated catchment area; and
(B) individuals who have previously been
migratory agricultural workers but who no
longer meet the requirements of subparagraph
(A) of paragraph (3) because of age or
disability and members of the families of such
individuals who are within such catchment area.
(2) Environmental concerns.--The Secretary may
enter into grants or contracts under this subsection
with public and private entities to--
(A) assist the States in the implementation
and enforcement of acceptable environmental
health standards, including enforcement of
standards for sanitation in migratory
agricultural worker and seasonal agricultural
worker labor camps, and applicable Federal and
State pesticide control standards; and
(B) conduct projects and studies to assist
the several States and entities which have
received grants or contracts under this section
in the assessment of problems related to camp
and field sanitation, exposure to unsafe levels
of agricultural chemicals including pesticides,
and other environmental health hazards to which
migratory agricultural workers and seasonal
agricultural workers, and members of their
families, are exposed.
(3) Definitions.--For purposes of this subsection:
(A) Migratory agricultural worker.--The
term ``migratory agricultural worker'' means an
individual whose principal employment is in
agriculture, who has been so employed within
the last 24 months, and who establishes for the
purposes of such employment a temporary abode.
(B) Seasonal agricultural worker.--The term
``seasonal agricultural worker'' means an
individual whose principal employment is in
agriculture on a seasonal basis and who is not
a migratory agricultural worker.
(C) Agriculture.--The term ``agriculture''
means farming in all its branches, including--
(i) cultivation and tillage of the
soil;
(ii) the production, cultivation,
growing, and harvesting of any
commodity grown on, in, or as an
adjunct to or part of a commodity grown
in or on, the land; and
(iii) any practice (including
preparation and processing for market
and delivery to storage or to market or
to carriers for transportation to
market) performed by a farmer or on a
farm incident to or in conjunction with
an activity described in clause (ii).
(h) Homeless Population.--
(1) In general.--The Secretary may award grants for
the purposes described in subsections (c), (e), and (f)
for the planning and delivery of services to a special
medically underserved population comprised of homeless
individuals, including grants for innovative programs
that provide outreach and comprehensive primary health
services to homeless children and youth and children
and youth at risk of homelessness.
(2) Required services.--In addition to required
primary health services (as defined in subsection
(b)(1)), an entity that receives a grant under this
subsection shall be required to provide substance abuse
services as a condition of such grant.
(3) Supplement not supplant requirement.--A grant
awarded under this subsection shall be expended to
supplement, and not supplant, the expenditures of the
health center and the value of in kind contributions
for the delivery of services to the population
described in paragraph (1).
(4) Temporary continued provision of services to
certain former homeless individuals.--If any grantee
under this subsection has provided services described
in this section under the grant to a homeless
individual, such grantee may, notwithstanding that the
individual is no longer homeless as a result of
becoming a resident in permanent housing, expend the
grant to continue to provide such services to the
individual for not more than 12 months.
(5) Definitions.--For purposes of this section:
(A) Homeless individual.--The term
``homeless individual'' means an individual who
lacks housing (without regard to whether the
individual is a member of a family), including
an individual whose primary residence during
the night is a supervised public or private
facility that provides temporary living
accommodations and an individual who is a
resident in transitional housing.
(B) Substance abuse.--The term ``substance
abuse'' has the same meaning given such term in
section 534(4).
(C) Substance abuse services.--The term
``substance abuse services'' includes
detoxification, risk reduction, outpatient
treatment, residential treatment, and
rehabilitation for substance abuse provided in
settings other than hospitals.
(i) Residents of Public Housing.--
(1) In general.--The Secretary may award grants for
the purposes described in subsections (c), (e), and (f)
for the planning and delivery of services to a special
medically underserved population comprised of residents
of public housing (such term, for purposes of this
subsection, shall have the same meaning given such term
in section 3(b)(1) of the United States Housing Act of
1937) and individuals living in areas immediately
accessible to such public housing.
(2) Supplement not supplant.--A grant awarded under
this subsection shall be expended to supplement, and
not supplant, the expenditures of the health center and
the value of in kind contributions for the delivery of
services to the population described in paragraph (1).
(3) Consultation with residents.--The Secretary may
not make a grant under paragraph (1) unless, with
respect to the residents of the public housing
involved, the applicant for the grant--
(A) has consulted with the residents in the
preparation of the application for the grant;
and
(B) agrees to provide for ongoing
consultation with the residents regarding the
planning and administration of the program
carried out with the grant.
(j) Access Grants.--
(1) In general.--The Secretary may award grants to
eligible health centers with a substantial number of
clients with limited English speaking proficiency to
provide translation, interpretation, and other such
services for such clients with limited English speaking
proficiency.
(2) Eligible health center.--In this subsection,
the term ``eligible health center'' means an entity
that--
(A) is a health center as defined under
subsection (a);
(B) provides health care services for
clients for whom English is a second language;
and
(C) has exceptional needs with respect to
linguistic access or faces exceptional
challenges with respect to linguistic access.
(3) Grant amount.--The amount of a grant awarded to
a center under this subsection shall be determined by
the Administrator. Such determination of such amount
shall be based on the number of clients for whom
English is a second language that is served by such
center, and larger grant amounts shall be awarded to
centers serving larger numbers of such clients.
(4) Use of funds.--An eligible health center that
receives a grant under this subsection may use funds
received through such grant to--
(A) provide translation, interpretation,
and other such services for clients for whom
English is a second language, including hiring
professional translation and interpretation
services; and
(B) compensate bilingual or multilingual
staff for language assistance services provided
by the staff for such clients.
(5) Application.--An eligible health center
desiring a grant under this subsection shall submit an
application to the Secretary at such time, in such
manner, and containing such information as the
Secretary may reasonably require, including--
(A) an estimate of the number of clients
that the center serves for whom English is a
second language;
(B) the ratio of the number of clients for
whom English is a second language to the total
number of clients served by the center;
(C) a description of any language
assistance services that the center proposes to
provide to aid clients for whom English is a
second language; and
(D) a description of the exceptional needs
of such center with respect to linguistic
access or a description of the exceptional
challenges faced by such center with respect to
linguistic access.
(6) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection, in addition to any funds authorized to be
appropriated or appropriated for health centers under
any other subsection of this section, such sums as may
be necessary for each of fiscal years 2002 through
2006.
(k) Applications.--
(1) Submission.--No grant may be made under this
section unless an application therefore is submitted
to, and approved by, the Secretary. Such an application
shall be submitted in such form and manner and shall
contain such information as the Secretary shall
prescribe.
(2) Description of need.--An application for a
grant under subparagraph (A) or (B) of subsection
(e)(1) for a health center shall include--
(A) a description of the need for health
services in the catchment area of the center;
(B) a demonstration by the applicant that
the area or the population group to be served
by the applicant has a shortage of personal
health services; and
(C) a demonstration that the center will be
located so that it will provide services to the
greatest number of individuals residing in the
catchment area or included in such population
group.
Such a demonstration shall be made on the basis of the
criteria prescribed by the Secretary under subsection
(b)(3) or on any other criteria which the Secretary may
prescribe to determine if the area or population group
to be served by the applicant has a shortage of
personal health services. In considering an application
for a grant under subparagraph (A) or (B) of subsection
(e)(1), the Secretary may require as a condition to the
approval of such application an assurance that the
applicant will provide any health service defined under
paragraphs (1) and (2) of subsection (b) that the
Secretary finds is needed to meet specific health needs
of the area to be served by the applicant. Such a
finding shall be made in writing and a copy shall be
provided to the applicant.
(3) Requirements.--Except as provided in subsection
(e)(1)(B), the Secretary may not approve an application
for a grant under subparagraph (A) or (B) of subsection
(e)(1) unless the Secretary determines that the entity
for which the application is submitted is a health
center (within the meaning of subsection (a)) and
that--
(A) the required primary health services of
the center will be available and accessible in
the catchment area of the center promptly, as
appropriate, and in a manner which assures
continuity;
(B) the center has made and will continue
to make every reasonable effort to establish
and maintain collaborative relationships with
other health care providers in the catchment
area of the center;
(C) the center will have an ongoing quality
improvement system that includes clinical
services and management, and that maintains the
confidentiality of patient records;
(D) the center will demonstrate its
financial responsibility by the use of such
accounting procedures and other requirements as
may be prescribed by the Secretary;
(E) the center--
(i)(I) has or will have a
contractual or other arrangement with
the agency of the State, in which it
provides services, which administers or
supervises the administration of a
State plan approved under title XIX of
the Social Security Act for the payment
of all or a part of the center's costs
in providing health services to persons
who are eligible for medical assistance
under such a State plan; and
(II) \1\ has or will have a
contractual or other
arrangement with the State
agency administering the
program under title XXI of such
Act (42 U.S.C. 1397aa et seq.)
with respect to individuals who
are State children's health
insurance program
beneficiaries; or
---------------------------------------------------------------------------
\1\ Indentation is so in law. See section 101(7)(A)(i)(III) of
Public Law 107-251 (116 Stat. 225).
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(ii) has made or will make every
reasonable effort to enter into
arrangements described in subclauses
(I) and (II) of clause (i);
(F) the center has made or will make and
will continue to make every reasonable effort
to collect appropriate reimbursement for its
costs in providing health services to persons
who are entitled to insurance benefits under
title XVIII of the Social Security Act, to
medical assistance under a State plan approved
under title XIX of such Act, or to assistance
for medical expenses under any other public
assistance program or private health insurance
program;
(G) the center--
(i) has prepared a schedule of fees
or payments for the provision of its
services consistent with locally
prevailing rates or charges and
designed to cover its reasonable costs
of operation and has prepared a
corresponding schedule of discounts to
be applied to the payment of such fees
or payments, which discounts are
adjusted on the basis of the patient's
ability to pay;
(ii) has made and will continue to
make every reasonable effort--
(I) to secure from patients
payment for services in
accordance with such schedules;
and
(II) to collect
reimbursement for health
services to persons described
in subparagraph (F) on the
basis of the full amount of
fees and payments for such
services without application of
any discount;
(iii)(I) will assure that no
patient will be denied health care
services due to an individual's
inability to pay for such services; and
(II) will assure that any fees or
payments required by the center for
such services will be reduced or waived
to enable the center to fulfill the
assurance described in subclause (I);
and
(iv) has submitted to the Secretary
such reports as the Secretary may
require to determine compliance with
this subparagraph;
(H) the center has established a governing
board which except in the case of an entity
operated by an Indian tribe or tribal or Indian
organization under the Indian Self-
Determination Act or an urban Indian
organization under the Indian Health Care
Improvement Act (25 U.S.C. 1651 et seq.)--
(i) is composed of individuals, a
majority of whom are being served by
the center and who, as a group,
represent the individuals being served
by the center;
(ii) meets at least once a month,
selects the services to be provided by
the center, schedules the hours during
which such services will be provided,
approves the center's annual budget,
approves the selection of a director
for the center, and, except in the case
of a governing board of a public center
(as defined in the second sentence of
this paragraph), establishes general
policies for the center; and
(iii) in the case of an application
for a second or subsequent grant for a
public center, has approved the
application or if the governing body
has not approved the application, the
failure of the governing body to
approve the application was
unreasonable;
except that, upon a showing of good cause the
Secretary shall waive, for the length of the
project period, all or part of the requirements
of this subparagraph in the case of a health
center that receives a grant pursuant to
subsection (g), (h), (i), or (p);
(I) the center has developed--
(i) an overall plan and budget that
meets the requirements of the
Secretary; and
(ii) an effective procedure for
compiling and reporting to the
Secretary such statistics and other
information as the Secretary may
require relating to--
(I) the costs of its
operations;
(II) the patterns of use of
its services;
(III) the availability,
accessibility, and
acceptability of its services;
and
(IV) such other matters
relating to operations of the
applicant as the Secretary may
require;
(J) the center will review periodically its
catchment area to--
(i) ensure that the size of such
area is such that the services to be
provided through the center (including
any satellite) are available and
accessible to the residents of the area
promptly and as appropriate;
(ii) ensure that the boundaries of
such area conform, to the extent
practicable, to relevant boundaries of
political subdivisions, school
districts, and Federal and State health
and social service programs; and
(iii) ensure that the boundaries of
such area eliminate, to the extent
possible, barriers to access to the
services of the center, including
barriers resulting from the area's
physical characteristics, its
residential patterns, its economic and
social grouping, and available
transportation;
(K) in the case of a center which serves a
population including a substantial proportion
of individuals of limited English-speaking
ability, the center has--
(i) developed a plan and made
arrangements responsive to the needs of
such population for providing services
to the extent practicable in the
language and cultural context most
appropriate to such individuals; and
(ii) identified an individual on
its staff who is fluent in both that
language and in English and whose
responsibilities shall include
providing guidance to such individuals
and to appropriate staff members with
respect to cultural sensitivities and
bridging linguistic and cultural
differences;
(L) the center, has developed an ongoing
referral relationship with one or more
hospitals; and
(M) the center encourages persons receiving
or seeking health services from the center to
participate in any public or private (including
employer-offered) health programs or plans for
which the persons are eligible, so long as the
center, in complying with this subparagraph,
does not violate the requirements of
subparagraph (G)(iii)(I).
For purposes of subparagraph (H), the term ``public
center'' means a health center funded (or to be funded)
through a grant under this section to a public agency.
(4) Approval of new or expanded service
applications.--The Secretary shall approve applications
for grants under subparagraph (A) or (B) of subsection
(e)(1) for health centers which--
(A) have not received a previous grant
under such subsection; or
(B) have applied for such a grant to expand
their services;
in such a manner that the ratio of the medically
underserved populations in rural areas which may be
expected to use the services provided by such centers
to the medically underserved populations in urban areas
which may be expected to use the services provided by
such centers is not less than two to three or greater
than three to two.
(l) Technical Assistance.--The Secretary shall establish a
program through which the Secretary shall provide (either
through the Department of Health and Human Services or by grant
or contract) technical and other assistance to eligible
entities to assist such entities to meet the requirements of
subsection (k)(3). Services provided through the program may
include necessary technical and nonfinancial assistance,
including fiscal and program management assistance, training in
fiscal and program management, operational and administrative
support, and the provision of information to the entities of
the variety of resources available under this title and how
those resources can be best used to meet the health needs of
the communities served by the entities.
(m) Memorandum of Agreement.--In carrying out this section,
the Secretary may enter into a memorandum of agreement with a
State. Such memorandum may include, where appropriate,
provisions permitting such State to--
(1) analyze the need for primary health services
for medically underserved populations within such
State;
(2) assist in the planning and development of new
health centers;
(3) review and comment upon annual program plans
and budgets of health centers, including comments upon
allocations of health care resources in the State;
(4) assist health centers in the development of
clinical practices and fiscal and administrative
systems through a technical assistance plan which is
responsive to the requests of health centers; and
(5) share information and data relevant to the
operation of new and existing health centers.
(n) Records.--
(1) In general.--Each entity which receives a grant
under subsection (e) shall establish and maintain such
records as the Secretary shall require.
(2) Availability.--Each entity which is required to
establish and maintain records under this subsection
shall make such books, documents, papers, and records
available to the Secretary or the Comptroller General
of the United States, or any of their duly authorized
representatives, for examination, copying or mechanical
reproduction on or off the premises of such entity upon
a reasonable request therefore. The Secretary and the
Comptroller General of the United States, or any of
their duly authorized representatives, shall have the
authority to conduct such examination, copying, and
reproduction.
(o) Delegation of Authority.--The Secretary may delegate
the authority to administer the programs authorized by this
section to any office, except that the authority to enter into,
modify, or issue approvals with respect to grants or contracts
may be delegated only within the central office of the Health
Resources and Services Administration.
(p) Special Consideration.--In making grants under this
section, the Secretary shall give special consideration to the
unique needs of sparsely populated rural areas, including
giving priority in the awarding of grants for new health
centers under subsections (c) and (e), and the granting of
waivers as appropriate and permitted under subsections
(b)(1)(B)(i) and (k)(3)(G).
(q) Audits.--
(1) In general.--Each entity which receives a grant
under this section shall provide for an independent
annual financial audit of any books, accounts,
financial records, files, and other papers and property
which relate to the disposition or use of the funds
received under such grant and such other funds received
by or allocated to the project for which such grant was
made. For purposes of assuring accurate, current, and
complete disclosure of the disposition or use of the
funds received, each such audit shall be conducted in
accordance with generally accepted accounting
principles. Each audit shall evaluate--
(A) the entity's implementation of the
guidelines established by the Secretary
respecting cost accounting,
(B) the processes used by the entity to
meet the financial and program reporting
requirements of the Secretary, and
(C) the billing and collection procedures
of the entity and the relation of the
procedures to its fee schedule and schedule of
discounts and to the availability of health
insurance and public programs to pay for the
health services it provides.
A report of each such audit shall be filed with the
Secretary at such time and in such manner as the
Secretary may require.
(2) Records.--Each entity which receives a grant
under this section shall establish and maintain such
records as the Secretary shall by regulation require to
facilitate the audit required by paragraph (1). The
Secretary may specify by regulation the form and manner
in which such records shall be established and
maintained.
(3) Availability of records.--Each entity which is
required to establish and maintain records or to
provide for and audit under this subsection shall make
such books, documents, papers, and records available to
the Secretary or the Comptroller General of the United
States, or any of their duly authorized
representatives, for examination, copying or mechanical
reproduction on or off the premises of such entity upon
a reasonable request therefore. The Secretary and the
Comptroller General of the United States, or any of
their duly authorized representatives, shall have the
authority to conduct such examination, copying, and
reproduction.
(4) Waiver.--The Secretary may, under appropriate
circumstances, waive the application of all or part of
the requirements of this subsection with respect to an
entity.
(r) Authorization of Appropriations.--
(1) General amounts for grants.--For the purpose of
carrying out this section, in addition to the amounts
authorized to be appropriated under subsection (d),
there is authorized to be appropriated the following:
(A) For fiscal year 2010, $2,988,821,592.
(B) For fiscal year 2011, $3,862,107,440.
(C) For fiscal year 2012, $4,990,553,440.
(D) For fiscal year 2013, $6,448,713,307.
(E) For fiscal year 2014, $7,332,924,155.
(F) For fiscal year 2015, $8,332,924,155.
(G) For fiscal year 2016, and each
subsequent fiscal year, the amount appropriated
for the preceding fiscal year adjusted by the
product of--
(i) one plus the average percentage
increase in costs incurred per patient
served; and
(ii) one plus the average
percentage increase in the total number
of patients served.
(2) Special provisions.--
(A) Public centers.--The Secretary may not
expend in any fiscal year, for grants under
this section to public centers (as defined in
the second sentence of subsection (k)(3)) the
governing boards of which (as described in
subsection (k)(3)(H)) do not establish general
policies for such centers, an amount which
exceeds 5 percent of the amounts appropriated
under this section for that fiscal year. For
purposes of applying the preceding sentence,
the term ``public centers'' shall not include
health centers that receive grants pursuant to
subsection (h) or (i).
(B) Distribution of grants.--For fiscal
year 2002 and each of the following fiscal
years, the Secretary, in awarding grants under
this section, shall ensure that the proportion
of the amount made available under each of
subsections (g), (h), and (i), relative to the
total amount appropriated to carry out this
section for that fiscal year, is equal to the
proportion of the amount made available under
that subsection for fiscal year 2001, relative
to the total amount appropriated to carry out
this section for fiscal year 2001.
(3) Funding report.--The Secretary shall annually
prepare and submit to the appropriate committees of
Congress a report concerning the distribution of funds
under this section that are provided to meet the health
care needs of medically underserved populations,
including the homeless, residents of public housing,
and migratory and seasonal agricultural workers, and
the appropriateness of the delivery systems involved in
responding to the needs of the particular populations.
Such report shall include an assessment of the relative
health care access needs of the targeted populations
and the rationale for any substantial changes in the
distribution of funds.
(4) Rule of construction with respect to rural
health clinics.--
(A) In general.--Nothing in this section
shall be construed to prevent a community
health center from contracting with a Federally
certified rural health clinic (as defined in
section 1861(aa)(2) of the Social Security
Act), a low-volume hospital (as defined for
purposes of section 1886 of such Act), a
critical access hospital, a sole community
hospital (as defined for purposes of section
1886(d)(5)(D)(iii) of such Act), or a medicare-
dependent share hospital (as defined for
purposes of section 1886(d)(5)(G)(iv) of such
Act) for the delivery of primary health care
services that are available at the clinic or
hospital to individuals who would otherwise be
eligible for free or reduced cost care if that
individual were able to obtain that care at the
community health center. Such services may be
limited in scope to those primary health care
services available in that clinic or hospitals.
(B) Assurances.--In order for a clinic or
hospital to receive funds under this section
through a contract with a community health
center under subparagraph (A), such clinic or
hospital shall establish policies to ensure--
(i) nondiscrimination based on the
ability of a patient to pay; and
(ii) the establishment of a sliding
fee scale for low-income patients.
(s) Demonstration Program for Individualized Wellness
Plans.--
(1) In general.--The Secretary shall establish a
pilot program to test the impact of providing at-risk
populations who utilize community health centers funded
under this section an individualized wellness plan that
is designed to reduce risk factors for preventable
conditions as identified by a comprehensive risk-factor
assessment.
(2) Agreements.--The Secretary shall enter into
agreements with not more than 10 community health
centers funded under this section to conduct activities
under the pilot program under paragraph (1).
(3) Wellness plans.--
(A) In general.--An individualized wellness
plan prepared under the pilot program under
this subsection may include one or more of the
following as appropriate to the individual's
identified risk factors:
(i) Nutritional counseling.
(ii) A physical activity plan.
(iii) Alcohol and smoking cessation
counseling and services.
(iv) Stress management.
(v) Dietary supplements that have
health claims approved by the
Secretary.
(vi) Compliance assistance provided
by a community health center employee.
(B) Risk factors.--Wellness plan risk
factors shall include--
(i) weight;
(ii) tobacco and alcohol use;
(iii) exercise rates;
(iv) nutritional status; and
(v) blood pressure.
(C) Comparisons.--Individualized wellness
plans shall make comparisons between the
individual involved and a control group of
individuals with respect to the risk factors
described in subparagraph (B).
(4) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection, such sums as may be necessary.
SEC. 330A. [254C] RURAL HEALTH CARE SERVICES OUTREACH, RURAL HEALTH
NETWORK DEVELOPMENT, AND SMALL HEALTH CARE PROVIDER
QUALITY IMPROVEMENT GRANT PROGRAMS.
(a) Purpose.--The purpose of this section is to provide
grants for expanded delivery of health care services in rural
areas, for the planning and implementation of integrated health
care networks in rural areas, and for the planning and
implementation of small health care provider quality
improvement activities.
(b) Definitions.--
(1) Director.--The term ``Director'' means the
Director specified in subsection (d).
(2) Federally qualified health center; rural health
clinic.--The terms ``Federally qualified health
center'' and ``rural health clinic'' have the meanings
given the terms in section 1861(aa) of the Social
Security Act (42 U.S.C. 1395x(aa)).
(3) Health professional shortage area.--The term
``health professional shortage area'' means a health
professional shortage area designated under section
332.
(4) Medically underserved community.--The term
``medically underserved community'' has the meaning
given the term in section 799B(6).
(5) Medically underserved population.--The term
``medically underserved population'' has the meaning
given the term in section 330(b)(3).
(c) Program.--The Secretary shall establish, under section
301, a small health care provider quality improvement grant
program.
(d) Administration.--
(1) Programs.--The rural health care services
outreach, rural health network development, and small
health care provider quality improvement grant programs
established under section 301 shall be administered by
the Director of the Office of Rural Health Policy of
the Health Resources and Services Administration, in
consultation with State offices of rural health or
other appropriate State government entities.
(2) Grants.--
(A) In general.--In carrying out the
programs described in paragraph (1), the
Director may award grants under subsections
(e), (f), and (g) to expand access to,
coordinate, and improve the quality of
essential health care services, and enhance the
delivery of health care, in rural areas.
(B) Types of grants.--The Director may
award the grants--
(i) to promote expanded delivery of
health care services in rural areas
under subsection (e);
(ii) to provide for the planning
and implementation of integrated health
care networks in rural areas under
subsection (f); and
(iii) to provide for the planning
and implementation of small health care
provider quality improvement activities
under subsection (g).
(e) Rural Health Care Services Outreach Grants.--
(1) Grants.--The Director may award grants to
eligible entities to promote rural health care services
outreach by expanding the delivery of health care
services to include new and enhanced services in rural
areas. The Director may award the grants for periods of
not more than 3 years.
(2) Eligibility.--To be eligible to receive a grant
under this subsection for a project, an entity--
(A) shall be a rural public or rural
nonprofit private entity;
(B) shall represent a consortium composed
of members--
(i) that include 3 or more health
care providers; and
(ii) that may be nonprofit or for-
profit entities; and
(C) shall not previously have received a
grant under this subsection for the same or a
similar project, unless the entity is proposing
to expand the scope of the project or the area
that will be served through the project.
(3) Applications.--To be eligible to receive a
grant under this subsection, an eligible entity, in
consultation with the appropriate State office of rural
health or another appropriate State entity, shall
prepare and submit to the Secretary an application, at
such time, in such manner, and containing such
information as the Secretary may require, including--
(A) a description of the project that the
eligible entity will carry out using the funds
provided under the grant;
(B) a description of the manner in which
the project funded under the grant will meet
the health care needs of rural underserved
populations in the local community or region to
be served;
(C) a description of how the local
community or region to be served will be
involved in the development and ongoing
operations of the project;
(D) a plan for sustaining the project after
Federal support for the project has ended;
(E) a description of how the project will
be evaluated; and
(F) other such information as the Secretary
determines to be appropriate.
(f) Rural Health Network Development Grants.--
(1) Grants.--
(A) In general.--The Director may award
rural health network development grants to
eligible entities to promote, through planning
and implementation, the development of
integrated health care networks that have
combined the functions of the entities
participating in the networks in order to--
(i) achieve efficiencies;
(ii) expand access to, coordinate,
and improve the quality of essential
health care services; and
(iii) strengthen the rural health
care system as a whole.
(B) Grant periods.--The Director may award
such a rural health network development grant
for implementation activities for a period of 3
years. The Director may also award such a rural
health network development grant for planning
activities for a period of 1 year, to assist in
the development of an integrated health care
network, if the proposed participants in the
network do not have a history of collaborative
efforts and a 3-year grant would be
inappropriate.
(2) Eligibility.--To be eligible to receive a grant
under this subsection, an entity--
(A) shall be a rural public or rural
nonprofit private entity;
(B) shall represent a network composed of
participants--
(i) that include 3 or more health
care providers; and
(ii) that may be nonprofit or for-
profit entities; and
(C) shall not previously have received a
grant under this subsection (other than a grant
for planning activities) for the same or a
similar project.
(3) Applications.--To be eligible to receive a
grant under this subsection, an eligible entity, in
consultation with the appropriate State office of rural
health or another appropriate State entity, shall
prepare and submit to the Secretary an application, at
such time, in such manner, and containing such
information as the Secretary may require, including--
(A) a description of the project that the
eligible entity will carry out using the funds
provided under the grant;
(B) an explanation of the reasons why
Federal assistance is required to carry out the
project;
(C) a description of--
(i) the history of collaborative
activities carried out by the
participants in the network;
(ii) the degree to which the
participants are ready to integrate
their functions; and
(iii) how the local community or
region to be served will benefit from
and be involved in the activities
carried out by the network;
(D) a description of how the local
community or region to be served will
experience increased access to quality health
care services across the continuum of care as a
result of the integration activities carried
out by the network;
(E) a plan for sustaining the project after
Federal support for the project has ended;
(F) a description of how the project will
be evaluated; and
(G) other such information as the Secretary
determines to be appropriate.
(g) Small Health Care Provider Quality Improvement
Grants.--
(1) Grants.--The Director may award grants to
provide for the planning and implementation of small
health care provider quality improvement activities.
The Director may award the grants for periods of 1 to 3
years.
(2) Eligibility.--To be eligible for a grant under
this subsection, an entity--
(A)(i) shall be a rural public or rural
nonprofit private health care provider or
provider of health care services, such as a
critical access hospital or a rural health
clinic; or
(ii) shall be another rural provider or
network of small rural providers identified by
the Secretary as a key source of local care;
and
(B) shall not previously have received a
grant under this subsection for the same or a
similar project.
(3) Applications.--To be eligible to receive a
grant under this subsection, an eligible entity, in
consultation with the appropriate State office of rural
health or another appropriate State entity shall
prepare and submit to the Secretary an application, at
such time, in such manner, and containing such
information as the Secretary may require, including--
(A) a description of the project that the
eligible entity will carry out using the funds
provided under the grant;
(B) an explanation of the reasons why
Federal assistance is required to carry out the
project;
(C) a description of the manner in which
the project funded under the grant will assure
continuous quality improvement in the provision
of services by the entity;
(D) a description of how the local
community or region to be served will
experience increased access to quality health
care services across the continuum of care as a
result of the activities carried out by the
entity;
(E) a plan for sustaining the project after
Federal support for the project has ended;
(F) a description of how the project will
be evaluated; and
(G) other such information as the Secretary
determines to be appropriate.
(4) Expenditures for small health care provider
quality improvement grants.--In awarding a grant under
this subsection, the Director shall ensure that the
funds made available through the grant will be used to
provide services to residents of rural areas. The
Director shall award not less than 50 percent of the
funds made available under this subsection to providers
located in and serving rural areas.
(h) General Requirements.--
(1) Prohibited uses of funds.--An entity that
receives a grant under this section may not use funds
provided through the grant--
(A) to build or acquire real property; or
(B) for construction.
(2) Coordination with other agencies.--The
Secretary shall coordinate activities carried out under
grant programs described in this section, to the extent
practicable, with Federal and State agencies and
nonprofit organizations that are operating similar
grant programs, to maximize the effect of public
dollars in funding meritorious proposals.
(3) Preference.--In awarding grants under this
section, the Secretary shall give preference to
entities that--
(A) are located in health professional
shortage areas or medically underserved
communities, or serve medically underserved
populations; or
(B) propose to develop projects with a
focus on primary care, and wellness and
prevention strategies.
(i) Report.--Not later than September 30, 2005, the
Secretary shall prepare and submit to the appropriate
committees of Congress a report on the progress and
accomplishments of the grant programs described in subsections
(e), (f), and (g).
(j) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $45,000,000 for
each of fiscal years 2008 through 2012.
SEC. 330A-1. [254C-1A] GRANTS TO NURSE-MANAGED HEALTH CLINICS.
(a) Definitions.--
(1) Comprehensive primary health care services.--In
this section, the term ``comprehensive primary health
care services'' means the primary health services
described in section 330(b)(1).
(2) Nurse-managed health clinic.--The term ``nurse-
managed health clinic'' means a nurse-practice
arrangement, managed by advanced practice nurses, that
provides primary care or wellness services to
underserved or vulnerable populations and that is
associated with a school, college, university or
department of nursing, federally qualified health
center, or independent nonprofit health or social
services agency.
(b) Authority to Award Grants.--The Secretary shall award
grants for the cost of the operation of nurse-managed health
clinics that meet the requirements of this section.
(c) Applications.--To be eligible to receive a grant under
this section, an entity shall--
(1) be an NMHC; and
(2) submit to the Secretary an application at such
time, in such manner, and containing--
(A) assurances that nurses are the major
providers of services at the NMHC and that at
least 1 advanced practice nurse holds an
executive management position within the
organizational structure of the NMHC;
(B) an assurance that the NMHC will
continue providing comprehensive primary health
care services or wellness services without
regard to income or insurance status of the
patient for the duration of the grant period;
and
(C) an assurance that, not later than 90
days of receiving a grant under this section,
the NMHC will establish a community advisory
committee, for which a majority of the members
shall be individuals who are served by the
NMHC.
(d) Grant Amount.--The amount of any grant made under this
section for any fiscal year shall be determined by the
Secretary, taking into account--
(1) the financial need of the NMHC, considering
State, local, and other operational funding provided to
the NMHC; and
(2) other factors, as the Secretary determines
appropriate.
(e) Authorization of Appropriations.--For the purposes of
carrying out this section, there are authorized to be
appropriated $50,000,000 for the fiscal year 2010 and such sums
as may be necessary for each of the fiscal years 2011 through
2014.
SEC. 330B. [254C-2] SPECIAL DIABETES PROGRAMS FOR TYPE I DIABETES. \1\
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\1\ Section 4923 of Public Law 105-33 (111 Stat. 574, as amended by
section 1(c) of Public Law 107-360 (116 Stat. 3019),) requires the
Secretary of Health and Human Services to conduct evaluations regarding
programs under sections 330B and 330C. An interim report is required to
be submitted to the appropriate committees of Congress not later than
January 1, 2000, and a final report is required to be submitted not
later than January 1, 2007.
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(a) In General.--The Secretary, directly or through grants,
shall provide for research into the prevention and cure of Type
I diabetes.
(b) Funding.--
(1) Transferred funds.--Notwithstanding section
2104(a) of the Social Security Act, from the amounts
appropriated in such section for each of fiscal years
1998 through 2002, $30,000,000 is hereby transferred
and made available in such fiscal year for grants under
this section.
(2) Appropriations.--For the purpose of making
grants under this section, there is appropriated, out
of any funds in the Treasury not otherwise
appropriated--
(A) $70,000,000 for each of fiscal years
2001 and 2002 (which shall be combined with
amounts transferred under paragraph (1) for
each such fiscal years);
(B) $100,000,000 for fiscal year 2003; and
(C) $150,000,000 for each of fiscal years
2004 through 2013.
SEC. 330C. [254C-3] SPECIAL DIABETES PROGRAMS FOR INDIANS. \1\
(a) In General.--The Secretary shall make grants for
providing services for the prevention and treatment of diabetes
in accordance with subsection (b).
(b) Services Through Indian Health Facilities.--For
purposes of subsection (a), services under such subsection are
provided in accordance with this subsection if the services are
provided through any of the following entities:
(1) The Indian Health Service.
(2) An Indian health program operated by an Indian
tribe or tribal organization pursuant to a contract,
grant, cooperative agreement, or compact with the
Indian Health Service pursuant to the Indian Self-
Determination Act.
(3) An urban Indian health program operated by an
urban Indian organization pursuant to a grant or
contract with the Indian Health Service pursuant to
title V of the Indian Health Care Improvement Act.
(c) Funding.--
(1) Transferred funds.--Notwithstanding section
2104(a) of the Social Security Act, from the amounts
appropriated in such section for each of fiscal years
1998 through 2002, $30,000,000, to remain available
until expended, is hereby transferred and made
available in such fiscal year for grants under this
section.
(2) Appropriations.--For the purpose of making
grants under this section, there is appropriated, out
of any money in the Treasury not otherwise
appropriated--
(A) $70,000,000 for each of fiscal years
2001 and 2002 (which shall be combined with
amounts transferred under paragraph (1) for
each such fiscal years);
(B) $100,000,000 for fiscal year 2003; and
(C) $150,000,000 for each of fiscal years
2004 through 2013.
SEC. 330D. [254C-4] CENTERS FOR STRATEGIES ON FACILITATING UTILIZATION
OF PREVENTIVE HEALTH SERVICES AMONG VARIOUS
POPULATIONS.
(a) In General.--The Secretary, acting through the
appropriate agencies of the Public Health Service, shall make
grants to public or nonprofit private entities for the
establishment and operation of regional centers whose purpose
is to develop, evaluate, and disseminate effective strategies,
which utilize quality management measures, to assist public and
private health care programs and providers in the appropriate
utilization of preventive health care services by specific
populations.
(b) Research and Training.--The activities carried out by a
center under subsection (a) may include establishing programs
of research and training with respect to the purpose described
in such subsection, including the development of curricula for
training individuals in implementing the strategies developed
under such subsection.
(c) Priority Regarding Infants and Children.--In carrying
out the purpose described in subsection (a), the Secretary
shall give priority to various populations of infants, young
children, and their mothers.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2000 through 2004.
SEC. 330E. [254C-5] EPILEPSY; SEIZURE DISORDER.
(a) National Public Health Campaign.--
(1) In general.--The Secretary shall develop and
implement public health surveillance, education,
research, and intervention strategies to improve the
lives of persons with epilepsy, with a particular
emphasis on children. Such projects may be carried out
by the Secretary directly and through awards of grants
or contracts to public or nonprofit private entities.
The Secretary may directly or through such awards
provide technical assistance with respect to the
planning, development, and operation of such projects.
(2) Certain activities.--Activities under paragraph
(1) shall include--
(A) expanding current surveillance
activities through existing monitoring systems
and improving registries that maintain data on
individuals with epilepsy, including children;
(B) enhancing research activities on the
diagnosis, treatment, and management of
epilepsy;
(C) implementing public and professional
information and education programs regarding
epilepsy, including initiatives which promote
effective management of the disease through
children's programs which are targeted to
parents, schools, daycare providers, patients;
(D) undertaking educational efforts with
the media, providers of health care, schools
and others regarding stigmas and secondary
disabilities related to epilepsy and seizures,
and its effects on youth;
(E) utilizing and expanding partnerships
with organizations with experience addressing
the health and related needs of people with
disabilities; and
(F) other activities the Secretary deems
appropriate.
(3) Coordination of activities.--The Secretary
shall ensure that activities under this subsection are
coordinated as appropriate with other agencies of the
Public Health Service that carry out activities
regarding epilepsy and seizure.
(b) Seizure Disorder; Demonstration Projects in Medically
Underserved Areas.--
(1) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make grants for the purpose of
carrying out demonstration projects to improve access
to health and other services regarding seizures to
encourage early detection and treatment in children and
others residing in medically underserved areas.
(2) Application for grant.--A grant may not be
awarded under paragraph (1) unless an application
therefore is submitted to the Secretary and the
Secretary approves such application. Such application
shall be submitted in such form and manner and shall
contain such information as the Secretary may
prescribe.
(c) Definitions.--For purposes of this section:
(1) The term ``epilepsy'' refers to a chronic and
serious neurological condition characterized by
excessive electrical discharges in the brain causing
recurring seizures affecting all life activities. The
Secretary may revise the definition of such term to the
extent the Secretary determines necessary.
(2) The term ``medically underserved'' has the
meaning applicable under section 799B(6).
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
SEC. 330F. [254C-6] CERTAIN SERVICES FOR PREGNANT WOMEN.
(a) Infant Adoption Awareness.--
(1) In general.--The Secretary shall make grants to
national, regional, or local adoption organizations for
the purpose of developing and implementing programs to
train the designated staff of eligible health centers
in providing adoption information and referrals to
pregnant women on an equal basis with all other courses
of action included in nondirective counseling to
pregnant women.
(2) Best-practices guidelines.--
(A) In general.--A condition for the
receipt of a grant under paragraph (1) is that
the adoption organization involved agree that,
in providing training under such paragraph, the
organization will follow the guidelines
developed under subparagraph (B).
(B) Process for development of
guidelines.--
(i) In general.--The Secretary
shall establish and supervise a process
described in clause (ii) in which the
participants are--
(I) an appropriate number
and variety of adoption
organizations that, as a group,
have expertise in all models of
adoption practice and that
represent all members of the
adoption triad (birth mother,
infant, and adoptive parent);
and
(II) affected public health
entities.
(ii) Description of process.--The
process referred to in clause (i) is a
process in which the participants
described in such clause collaborate to
develop best-practices guidelines on
the provision of adoption information
and referrals to pregnant women on an
equal basis with all other courses of
action included in nondirective
counseling to pregnant women.
(iii) Date certain for
development.--The Secretary shall
ensure that the guidelines described in
clause (ii) are developed not later
than 180 days after the date of the
enactment of the Children's Health Act
of 2000 \1\.
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(C) Relation to authority for grants.--The
Secretary may not make any grant under
paragraph (1) before the date on which the
guidelines under subparagraph (B) are
developed.
(3) Use of grant.--
(A) In general.--With respect to a grant
under paragraph (1)--
(i) an adoption organization may
expend the grant to carry out the
programs directly or through grants to
or contracts with other adoption
organizations;
(ii) the purposes for which the
adoption organization expends the grant
may include the development of a
training curriculum, consistent with
the guidelines developed under
paragraph (2)(B); and
(iii) a condition for the receipt
of the grant is that the adoption
organization agree that, in providing
training for the designated staff of
eligible health centers, such
organization will make reasonable
efforts to ensure that the individuals
who provide the training are
individuals who are knowledgeable in
all elements of the adoption process
and are experienced in providing
adoption information and referrals in
the geographic areas in which the
eligible health centers are located,
and that the designated staff receive
the training in such areas.
(B) Rule of construction regarding training
of trainers.--With respect to individuals who
under a grant under paragraph (1) provide
training for the designated staff of eligible
health centers (referred to in this
subparagraph as ``trainers''), subparagraph
(A)(iii) may not be construed as establishing
any limitation regarding the geographic area in
which the trainers receive instruction in being
such trainers. A trainer may receive such
instruction in a different geographic area than
the area in which the trainer trains (or will
train) the designated staff of eligible health
centers.
(4) Adoption organizations; eligible health
centers; other definitions.--For purposes of this
section:
(A) The term ``adoption organization''
means a national, regional, or local
organization--
(i) among whose primary purposes
are adoption;
(ii) that is knowledgeable in all
elements of the adoption process and on
providing adoption information and
referrals to pregnant women; and
(iii) that is a nonprofit private
entity.
(B) The term ``designated staff'', with
respect to an eligible health center, means
staff of the center who provide pregnancy or
adoption information and referrals (or will
provide such information and referrals after
receiving training under a grant under
paragraph (1)).
(C) The term ``eligible health centers''
means public and nonprofit private entities
that provide health services to pregnant women.
(5) Training for certain eligible health centers.--
A condition for the receipt of a grant under paragraph
(1) is that the adoption organization involved agree to
make reasonable efforts to ensure that the eligible
health centers with respect to which training under the
grant is provided include--
(A) eligible health centers that receive
grants under section 1001 (relating to
voluntary family planning projects);
(B) eligible health centers that receive
grants under section 330 (relating to community
health centers, migrant health centers, and
centers regarding homeless individuals and
residents of public housing); and
(C) eligible health centers that receive
grants under this Act for the provision of
services in schools.
(6) Participation of certain eligible health
clinics.--In the case of eligible health centers that
receive grants under section 330 or 1001:
(A) Within a reasonable period after the
Secretary begins making grants under paragraph
(1), the Secretary shall provide eligible
health centers with complete information about
the training available from organizations
receiving grants under such paragraph. The
Secretary shall make reasonable efforts to
encourage eligible health centers to arrange
for designated staff to participate in such
training. Such efforts shall affirm Federal
requirements, if any, that the eligible health
center provide nondirective counseling to
pregnant women.
(B) All costs of such centers in obtaining
the training shall be reimbursed by the
organization that provides the training, using
grants under paragraph (1).
(C) Not later than 1 year after the date of
the enactment of the Children's Health Act of
2000 \1\, the Secretary shall submit to the
appropriate committees of the Congress a report
evaluating the extent to which adoption
information and referral, upon request, are
provided by eligible health centers. Within a
reasonable time after training under this
section is initiated, the Secretary shall
submit to the appropriate committees of the
Congress a report evaluating the extent to
which adoption information and referral, upon
request, are provided by eligible health
centers in order to determine the effectiveness
of such training and the extent to which such
training complies with subsection (a)(1). In
preparing the reports required by this
subparagraph, the Secretary shall in no respect
interpret the provisions of this section to
allow any interference in the provider-patient
relationship, any breach of patient
confidentiality, or any monitoring or auditing
of the counseling process or patient records
which breaches patient confidentiality or
reveals patient identity. The reports required
by this subparagraph shall be conducted by the
Secretary acting through the Administrator of
the Health Resources and Services
Administration and in collaboration with the
Director of the Agency for Healthcare Research
and Quality.
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\1\ Public Law 106-310, enacted October 17, 2000.
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(b) Application for Grant.--The Secretary may make a grant
under subsection (a) only if an application for the grant is
submitted to the Secretary and the application is in such form,
is made in such manner, and contains such agreements,
assurances, and information as the Secretary determines to be
necessary to carry out this section.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
SEC. 330G. [254C-7] SPECIAL NEEDS ADOPTION PROGRAMS; PUBLIC AWARENESS
CAMPAIGN AND OTHER ACTIVITIES.
(a) Special Needs Adoption Awareness Campaign.--
(1) In general.--The Secretary shall, through
making grants to nonprofit private entities, provide
for the planning, development, and carrying out of a
national campaign to provide information to the public
regarding the adoption of children with special needs.
(2) Input on planning and development.--In
providing for the planning and development of the
national campaign under paragraph (1), the Secretary
shall provide for input from a number and variety of
adoption organizations throughout the States in order
that the full national diversity of interests among
adoption organizations is represented in the planning
and development of the campaign.
(3) Certain features.--With respect to the national
campaign under paragraph (1):
(A) The campaign shall be directed at
various populations, taking into account as
appropriate differences among geographic
regions, and shall be carried out in the
language and cultural context that is most
appropriate to the population involved.
(B) The means through which the campaign
may be carried out include--
(i) placing public service
announcements on television, radio, and
billboards; and
(ii) providing information through
means that the Secretary determines
will reach individuals who are most
likely to adopt children with special
needs.
(C) The campaign shall provide information
on the subsidies and supports that are
available to individuals regarding the adoption
of children with special needs.
(D) The Secretary may provide that the
placement of public service announcements, and
the dissemination of brochures and other
materials, is subject to review by the
Secretary.
(4) Matching Requirement.--
(A) In general.--With respect to the costs
of the activities to be carried out by an
entity pursuant to paragraph (1), a condition
for the receipt of a grant under such paragraph
is that the entity agree to make available
(directly or through donations from public or
private entities) non-Federal contributions
toward such costs in an amount that is not less
than 25 percent of such costs.
(B) Determination of amount contributed.--
Non-Federal contributions under subparagraph
(A) may be in cash or in kind, fairly
evaluated, including plant, equipment, or
services. Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of such contributions.
(b) National Resources Program.--The Secretary shall
(directly or through grant or contract) carry out a program
that, through toll-free telecommunications, makes available to
the public information regarding the adoption of children with
special needs. Such information shall include the following:
(1) A list of national, State, and regional
organizations that provide services regarding such
adoptions, including exchanges and other information on
communicating with the organizations. The list shall
represent the full national diversity of adoption
organizations.
(2) Information beneficial to individuals who adopt
such children, including lists of support groups for
adoptive parents and other postadoptive services.
(c) Other Programs.--With respect to the adoption of
children with special needs, the Secretary shall make grants--
(1) to provide assistance to support groups for
adoptive parents, adopted children, and siblings of
adopted children; and
(2) to carry out studies to identify--
(A) the barriers to completion of the
adoption process; and
(B) those components that lead to favorable
long-term outcomes for families that adopt
children with special needs.
(d) Application for Grant.--The Secretary may make an award
of a grant or contract under this section only if an
application for the award is submitted to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out this section.
(e) Funding.--For the purpose of carrying out this section,
there are authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2001 through 2005.
SEC. 330H. [254C-8] HEALTHY START FOR INFANTS.
(a) In General.--
(1) Continuation and expansion of program.--The
Secretary, acting through the Administrator of the
Health Resources and Services Administration, Maternal
and Child Health Bureau, shall under authority of this
section continue in effect the Healthy Start Initiative
and may, during fiscal year 2001 and subsequent years,
carry out such program on a national basis.
(2) Definition.--For purposes of paragraph (1), the
term ``Healthy Start Initiative'' is a reference to the
program that, as an initiative to reduce the rate of
infant mortality and improve perinatal outcomes, makes
grants for project areas with high annual rates of
infant mortality and that, prior to the effective date
of this section, was a demonstration program carried
out under section 301.
(b) Considerations in Making Grants.--
(1) Requirements.--In making grants under
subsection (a), the Secretary shall require that
applicants (in addition to meeting all eligibility
criteria established by the Secretary) establish, for
project areas under such subsection, community-based
consortia of individuals and organizations (including
agencies responsible for administering block grant
programs under title V of the Social Security Act,
consumers of project services, public health
departments, hospitals, health centers under section
330, and other significant sources of health care
services) that are appropriate for participation in
projects under subsection (a).
(2) Other considerations.--In making grants under
subsection (a), the Secretary shall take into
consideration the following:
(A) Factors that contribute to infant
mortality, such as low birthweight.
(B) The extent to which applicants for such
grants facilitate--
(i) a community-based approach to
the delivery of services; and
(ii) a comprehensive approach to
women's health care to improve
perinatal outcomes.
(3) Special projects.--Nothing in paragraph (2)
shall be construed to prevent the Secretary from
awarding grants under subsection (a) for special
projects that are intended to address significant
disparities in perinatal health indicators in
communities along the United States-Mexico border or in
Alaska or Hawaii.
(c) Coordination.--Recipients of grants under subsection
(a) shall coordinate their services and activities with the
State agency or agencies that administer block grant programs
under title V of the Social Security Act in order to promote
cooperation, integration, and dissemination of information with
Statewide systems and with other community services funded
under the Maternal and Child Health Block Grant.
(d) Rule of Construction.--Except to the extent
inconsistent with this section, this section may not be
construed as affecting the authority of the Secretary to make
modifications in the program carried out under subsection (a).
(e) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out this section, there are
authorized to be appropriated--
(A) $120,000,000 for fiscal year 2008; and
(B) for each of fiscal years 2009 through
2013, the amount authorized for the preceding
fiscal year increased by the percentage
increase in the Consumer Price Index for all
urban consumers for such year.
(2) Allocation.--
(A) Program administration.--Of the amounts
appropriated under paragraph (1) for a fiscal
year, the Secretary may reserve up to 5 percent
for coordination, dissemination, technical
assistance, and data activities that are
determined by the Secretary to be appropriate
for carrying out the program under this
section.
(B) Evaluation.--Of the amounts
appropriated under paragraph (1) for a fiscal
year, the Secretary may reserve up to 1 percent
for evaluations of projects carried out under
subsection (a). Each such evaluation shall
include a determination of whether such
projects have been effective in reducing the
disparity in health status between the general
population and individuals who are members of
racial or ethnic minority groups.
SEC. 330I. [254C-14] TELEHEALTH NETWORK AND TELEHEALTH RESOURCE CENTERS
GRANT PROGRAMS.
(a) Definitions.--In this section:
(1) Director; office.--The terms ``Director'' and
``Office'' mean the Director and Office specified in
subsection (c).
(2) Federally qualified health center and rural
health clinic.--The term ``Federally qualified health
center'' and ``rural health clinic'' have the meanings
given the terms in section 1861(aa) of the Social
Security Act (42 U.S.C. 1395x(aa)).
(3) Frontier community.--The term ``frontier
community'' shall have the meaning given the term in
regulations issued under subsection (r).
(4) Medically underserved area.--The term
``medically underserved area'' has the meaning given
the term ``medically underserved community'' in section
799B(6).
(5) Medically underserved population.--The term
``medically underserved population'' has the meaning
given the term in section 330(b)(3).
(6) Telehealth services.--The term ``telehealth
services'' means services provided through telehealth
technologies.
(7) Telehealth technologies.--The term ``telehealth
technologies'' means technologies relating to the use
of electronic information, and telecommunications
technologies, to support and promote, at a distance,
health care, patient and professional health-related
education, health administration, and public health.
(b) Programs.--The Secretary shall establish, under section
301, telehealth network and telehealth resource centers grant
programs.
(c) Administration.--
(1) Establishment.--There is established in the
Health Resources and Services Administration an Office
for the Advancement of Telehealth. The Office shall be
headed by a Director.
(2) Duties.--The telehealth network and telehealth
resource centers grant programs established under
section 301 shall be administered by the Director, in
consultation with the State offices of rural health,
State offices concerning primary care, or other
appropriate State government entities.
(d) Grants.--
(1) Telehealth network grants.--The Director may,
in carrying out the telehealth network grant program
referred to in subsection (b), award grants to eligible
entities for projects to demonstrate how telehealth
technologies can be used through telehealth networks in
rural areas, frontier communities, and medically
underserved areas, and for medically underserved
populations, to--
(A) expand access to, coordinate, and
improve the quality of health care services;
(B) improve and expand the training of
health care providers; and
(C) expand and improve the quality of
health information available to health care
providers, and patients and their families, for
decisionmaking.
(2) Telehealth resource centers grants.--The
Director may, in carrying out the telehealth resource
centers grant program referred to in subsection (b),
award grants to eligible entities for projects to
demonstrate how telehealth technologies can be used in
the areas and communities, and for the populations,
described in paragraph (1), to establish telehealth
resource centers.
(e) Grant Periods.--The Director may award grants under
this section for periods of not more than 4 years.
(f) Eligible Entities.--
(1) Telehealth network grants.--
(A) Grant recipient.--To be eligible to
receive a grant under subsection (d)(1), an
entity shall be a nonprofit entity.
(B) Telehealth networks.--
(i) In general.--To be eligible to
receive a grant under subsection
(d)(1), an entity shall demonstrate
that the entity will provide services
through a telehealth network.
(ii) Nature of entities.--Each
entity participating in the telehealth
network may be a nonprofit or for-
profit entity.
(iii) Composition of network.--The
telehealth network shall include at
least 2 of the following entities (at
least 1 of which shall be a community-
based health care provider):
(I) Community or migrant
health centers or other
Federally qualified health
centers.
(II) Health care providers,
including pharmacists, in
private practice.
(III) Entities operating
clinics, including rural health
clinics.
(IV) Local health
departments.
(V) Nonprofit hospitals,
including community access
hospitals.
(VI) Other publicly funded
health or social service
agencies.
(VII) Long-term care
providers.
(VIII) Providers of health
care services in the home.
(IX) Providers of
outpatient mental health
services and entities operating
outpatient mental health
facilities.
(X) Local or regional
emergency health care
providers.
(XI) Institutions of higher
education.
(XII) Entities operating
dental clinics.
(2) Telehealth resource centers grants.--To be
eligible to receive a grant under subsection (d)(2), an
entity shall be a nonprofit entity.
(g) Applications.--To be eligible to receive a grant under
subsection (d), an eligible entity, in consultation with the
appropriate State office of rural health or another appropriate
State entity, shall prepare and submit to the Secretary an
application, at such time, in such manner, and containing such
information as the Secretary may require, including--
(1) a description of the project that the eligible
entity will carry out using the funds provided under
the grant;
(2) a description of the manner in which the
project funded under the grant will meet the health
care needs of rural or other populations to be served
through the project, or improve the access to services
of, and the quality of the services received by, those
populations;
(3) evidence of local support for the project, and
a description of how the areas, communities, or
populations to be served will be involved in the
development and ongoing operations of the project;
(4) a plan for sustaining the project after Federal
support for the project has ended;
(5) information on the source and amount of non-
Federal funds that the entity will provide for the
project;
(6) information demonstrating the long-term
viability of the project, and other evidence of
institutional commitment of the entity to the project;
(7) in the case of an application for a project
involving a telehealth network, information
demonstrating how the project will promote the
integration of telehealth technologies into the
operations of health care providers, to avoid
redundancy, and improve access to and the quality of
care; and
(8) other such information as the Secretary
determines to be appropriate.
(h) Terms; Conditions; Maximum Amount of Assistance.--The
Secretary shall establish the terms and conditions of each
grant program described in subsection (b) and the maximum
amount of a grant to be awarded to an individual recipient for
each fiscal year under this section. The Secretary shall
publish, in a publication of the Health Resources and Services
Administration, notice of the application requirements for each
grant program described in subsection (b) for each fiscal year.
(i) Preferences.--
(1) Telehealth networks.--In awarding grants under
subsection (d)(1) for projects involving telehealth
networks, the Secretary shall give preference to an
eligible entity that meets at least 1 of the following
requirements:
(A) Organization.--The eligible entity is a
rural community-based organization or another
community-based organization.
(B) Services.--The eligible entity proposes
to use Federal funds made available through
such a grant to develop plans for, or to
establish, telehealth networks that provide
mental health, public health, long-term care,
home care, preventive, or case management
services.
(C) Coordination.--The eligible entity
demonstrates how the project to be carried out
under the grant will be coordinated with other
relevant federally funded projects in the
areas, communities, and populations to be
served through the grant.
(D) Network.--The eligible entity
demonstrates that the project involves a
telehealth network that includes an entity
that--
(i) provides clinical health care
services, or educational services for
health care providers and for patients
or their families; and
(ii) is--
(I) a public library;
(II) an institution of
higher education; or
(III) a local government
entity.
(E) Connectivity.--The eligible entity
proposes a project that promotes local
connectivity within areas, communities, or
populations to be served through the project.
(F) Integration.--The eligible entity
demonstrates that health care information has
been integrated into the project.
(2) Telehealth resource centers.--In awarding
grants under subsection (d)(2) for projects involving
telehealth resource centers, the Secretary shall give
preference to an eligible entity that meets at least 1
of the following requirements:
(A) Provision of services.--The eligible
entity has a record of success in the provision
of telehealth services to medically underserved
areas or medically underserved populations.
(B) Collaboration and sharing of
expertise.--The eligible entity has a
demonstrated record of collaborating and
sharing expertise with providers of telehealth
services at the national, regional, State, and
local levels.
(C) Broad range of telehealth services.--
The eligible entity has a record of providing a
broad range of telehealth services, which may
include--
(i) a variety of clinical specialty
services;
(ii) patient or family education;
(iii) health care professional
education; and
(iv) rural residency support
programs.
(j) Distribution of Funds.--
(1) In general.--In awarding grants under this
section, the Director shall ensure, to the greatest
extent possible, that such grants are equitably
distributed among the geographical regions of the
United States.
(2) Telehealth networks.--In awarding grants under
subsection (d)(1) for a fiscal year, the Director shall
ensure that--
(A) not less than 50 percent of the funds
awarded shall be awarded for projects in rural
areas; and
(B) the total amount of funds awarded for
such projects for that fiscal year shall be not
less than the total amount of funds awarded for
such projects for fiscal year 2001 under
section 330A (as in effect on the day before
the date of enactment of the Health Care Safety
Net Amendments of 2002).
(k) Use of Funds.--
(1) Telehealth network program.--The recipient of a
grant under subsection (d)(1) may use funds received
through such grant for salaries, equipment, and
operating or other costs, including the cost of--
(A) developing and delivering clinical
telehealth services that enhance access to
community-based health care services in rural
areas, frontier communities, or medically
underserved areas, or for medically underserved
populations;
(B) developing and acquiring, through lease
or purchase, computer hardware and software,
audio and video equipment, computer network
equipment, interactive equipment, data terminal
equipment, and other equipment that furthers
the objectives of the telehealth network grant
program;
(C)(i) developing and providing distance
education, in a manner that enhances access to
care in rural areas, frontier communities, or
medically underserved areas, or for medically
underserved populations; or
(ii) mentoring, precepting, or supervising
health care providers and students seeking to
become health care providers, in a manner that
enhances access to care in the areas and
communities, or for the populations, described
in clause (i);
(D) developing and acquiring instructional
programming;
(E)(i) providing for transmission of
medical data, and maintenance of equipment; and
(ii) providing for compensation (including
travel expenses) of specialists, and referring
health care providers, who are providing
telehealth services through the telehealth
network, if no third party payment is available
for the telehealth services delivered through
the telehealth network;
(F) developing projects to use telehealth
technology to facilitate collaboration between
health care providers;
(G) collecting and analyzing usage
statistics and data to document the cost-
effectiveness of the telehealth services; and
(H) carrying out such other activities as
are consistent with achieving the objectives of
this section, as determined by the Secretary.
(2) Telehealth resource centers.--The recipient of
a grant under subsection (d)(2) may use funds received
through such grant for salaries, equipment, and
operating or other costs for--
(A) providing technical assistance,
training, and support, and providing for travel
expenses, for health care providers and a range
of health care entities that provide or will
provide telehealth services;
(B) disseminating information and research
findings related to telehealth services;
(C) promoting effective collaboration among
telehealth resource centers and the Office;
(D) conducting evaluations to determine the
best utilization of telehealth technologies to
meet health care needs;
(E) promoting the integration of the
technologies used in clinical information
systems with other telehealth technologies;
(F) fostering the use of telehealth
technologies to provide health care information
and education for health care providers and
consumers in a more effective manner; and
(G) implementing special projects or
studies under the direction of the Office.
(l) Prohibited Uses of Funds.--An entity that receives a
grant under this section may not use funds made available
through the grant--
(1) to acquire real property;
(2) for expenditures to purchase or lease
equipment, to the extent that the expenditures would
exceed 40 percent of the total grant funds;
(3) in the case of a project involving a telehealth
network, to purchase or install transmission equipment
(such as laying cable or telephone lines, or purchasing
or installing microwave towers, satellite dishes,
amplifiers, or digital switching equipment);
(4) to pay for any equipment or transmission costs
not directly related to the purposes for which the
grant is awarded;
(5) to purchase or install general purpose voice
telephone systems;
(6) for construction; or
(7) for expenditures for indirect costs (as
determined by the Secretary), to the extent that the
expenditures would exceed 15 percent of the total grant
funds.
(m) Collaboration.--In providing services under this
section, an eligible entity shall collaborate, if feasible,
with entities that--
(1)(A) are private or public organizations, that
receive Federal or State assistance; or
(B) are public or private entities that operate
centers, or carry out programs, that receive Federal or
State assistance; and
(2) provide telehealth services or related
activities.
(n) Coordination With Other Agencies.--The Secretary shall
coordinate activities carried out under grant programs
described in subsection (b), to the extent practicable, with
Federal and State agencies and nonprofit organizations that are
operating similar programs, to maximize the effect of public
dollars in funding meritorious proposals.
(o) Outreach Activities.--The Secretary shall establish and
implement procedures to carry out outreach activities to advise
potential end users of telehealth services in rural areas,
frontier communities, medically underserved areas, and
medically underserved populations in each State about the grant
programs described in subsection (b).
(p) Telehealth.--It is the sense of Congress that, for
purposes of this section, States should develop reciprocity
agreements so that a provider of services under this section
who is a licensed or otherwise authorized health care provider
under the law of 1 or more States, and who, through telehealth
technology, consults with a licensed or otherwise authorized
health care provider in another State, is exempt, with respect
to such consultation, from any State law of the other State
that prohibits such consultation on the basis that the first
health care provider is not a licensed or authorized health
care provider under the law of that State.
(q) Report.--Not later than September 30, 2005, the
Secretary shall prepare and submit to the appropriate
committees of Congress a report on the progress and
accomplishments of the grant programs described in subsection
(b).
(r) Regulations.--The Secretary shall issue regulations
specifying, for purposes of this section, a definition of the
term ``frontier area''. The definition shall be based on
factors that include population density, travel distance in
miles to the nearest medical facility, travel time in minutes
to the nearest medical facility, and such other factors as the
Secretary determines to be appropriate. The Secretary shall
develop the definition in consultation with the Director of the
Bureau of the Census and the Administrator of the Economic
Research Service of the Department of Agriculture.
(s) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section--
(1) for grants under subsection (d)(1), $40,000,000
for fiscal year 2002, and such sums as may be necessary
for each of fiscal years 2003 through 2006; and
(2) for grants under subsection (d)(2), $20,000,000
for fiscal year 2002, and such sums as may be necessary
for each of fiscal years 2003 through 2006.
SEC. 330J. [254C-15] RURAL EMERGENCY MEDICAL SERVICE TRAINING AND
EQUIPMENT ASSISTANCE PROGRAM.
(a) Grants.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration (referred to in this section as the
``Secretary'') shall award grants to eligible entities to
enable such entities to provide for improved emergency medical
services in rural areas.
(b) Eligibility.--To be eligible to receive a grant under
this section, an entity shall--
(1) be--
(A) a State emergency medical services
office;
(B) a State emergency medical services
association;
(C) a State office of rural health;
(D) a local government entity;
(E) a State or local ambulance provider; or
(F) any other entity determined appropriate
by the Secretary; and
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require, that includes--
(A) a description of the activities to be
carried out under the grant; and
(B) an assurance that the eligible entity
will comply with the matching requirement of
subsection (e).
(c) Use of Funds.--An entity shall use amounts received
under a grant made under subsection (a), either directly or
through grants to emergency medical service squads that are
located in, or that serve residents of, a nonmetropolitan
statistical area, an area designated as a rural area by any law
or regulation of a State, or a rural census tract of a
metropolitan statistical area (as determined under the most
recent Goldsmith Modification, originally published in a notice
of availability of funds in the Federal Register on February
27, 1992, 57 Fed. Reg. 6725), to--
(1) recruit emergency medical service personnel;
(2) recruit volunteer emergency medical service
personnel;
(3) train emergency medical service personnel in
emergency response, injury prevention, safety
awareness, and other topics relevant to the delivery of
emergency medical services;
(4) fund specific training to meet Federal or State
certification requirements;
(5) develop new ways to educate emergency health
care providers through the use of technology-enhanced
educational methods (such as distance learning);
(6) acquire emergency medical services equipment,
including cardiac defibrillators;
(7) acquire personal protective equipment for
emergency medical services personnel as required by the
Occupational Safety and Health Administration; and
(8) educate the public concerning cardiopulmonary
resuscitation, first aid, injury prevention, safety
awareness, illness prevention, and other related
emergency preparedness topics.
(d) Preference.--In awarding grants under this section the
Secretary shall give preference to--
(1) applications that reflect a collaborative
effort by 2 or more of the entities described in
subparagraphs (A) through (F) of subsection (b)(1); and
(2) applications submitted by entities that intend
to use amounts provided under the grant to fund
activities described in any of paragraphs (1) through
(5) of subsection (c).
(e) Matching Requirement.--The Secretary may not award a
grant under this section to an entity unless the entity agrees
that the entity will make available (directly or through
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out
under the grant in an amount equal to 25 percent of the amount
received under the grant.
(f) Emergency Medical Services.--In this section, the term
``emergency medical services''--
(1) means resources used by a qualified public or
private nonprofit entity, or by any other entity
recognized as qualified by the State involved, to
deliver medical care outside of a medical facility
under emergency conditions that occur--
(A) as a result of the condition of the
patient; or
(B) as a result of a natural disaster or
similar situation; and
(2) includes services delivered by an emergency
medical services provider (either compensated or
volunteer) or other provider recognized by the State
involved that is licensed or certified by the State as
an emergency medical technician or its equivalent (as
determined by the State), a registered nurse, a
physician assistant, or a physician that provides
services similar to services provided by such an
emergency medical services provider.
(g) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2002 through
2006.
(2) Administrative costs.--The Secretary may use
not more than 10 percent of the amount appropriated
under paragraph (1) for a fiscal year for the
administrative expenses of carrying out this section.
SEC. 330K. [254C-16] MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
(a) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity''
means a public or nonprofit private telehealth provider
network that offers services that include mental health
services provided by qualified mental health providers.
(2) Qualified mental health professionals.--The
term ``qualified mental health professionals'' refers
to providers of mental health services reimbursed under
the medicare program carried out under title XVIII of
the Social Security Act (42 U.S.C. 1395 et seq.) who
have additional training in the treatment of mental
illness in children and adolescents or who have
additional training in the treatment of mental illness
in the elderly.
(3) Special populations.--The term ``special
populations'' refers to the following 2 distinct
groups:
(A) Children and adolescents in mental
health underserved rural areas or in mental
health underserved urban areas.
(B) Elderly individuals located in long-
term care facilities in mental health
underserved rural or urban areas.
(4) Telehealth.--The term ``telehealth'' means the
use of electronic information and telecommunications
technologies to support long distance clinical health
care, patient and professional health-related
education, public health, and health administration.
(b) Program Authorized.--
(1) In general.--The Secretary, acting through the
Director of the Office for the Advancement of
Telehealth of the Health Resources and Services
Administration, shall award grants to eligible entities
to establish demonstration projects for the provision
of mental health services to special populations as
delivered remotely by qualified mental health
professionals using telehealth and for the provision of
education regarding mental illness as delivered
remotely by qualified mental health professionals using
telehealth.
(2) Populations served.--The Secretary shall award
the grants under paragraph (1) in a manner that
distributes the grants so as to serve equitably the
populations described in subparagraphs (A) and (B) of
subsection (a)(3).
(c) Use of Funds.--
(1) In general.--An eligible entity that receives a
grant under this section shall use the grant funds--
(A) for the populations described in
subsection (a)(3)(A)--
(i) to provide mental health
services, including diagnosis and
treatment of mental illness, as
delivered remotely by qualified mental
health professionals using telehealth;
and
(ii) to collaborate with local
public health entities to provide the
mental health services; and
(B) for the populations described in
subsection (a)(3)(B)--
(i) to provide mental health
services, including diagnosis and
treatment of mental illness, in long-
term care facilities as delivered
remotely by qualified mental health
professionals using telehealth; and
(ii) to collaborate with local
public health entities to provide the
mental health services.
(2) Other uses.--An eligible entity that receives a
grant under this section may also use the grant funds
to--
(A) pay telecommunications costs; and
(B) pay qualified mental health
professionals on a reasonable cost basis as
determined by the Secretary for services
rendered.
(3) Prohibited uses.--An eligible entity that
receives a grant under this section shall not use the
grant funds to--
(A) purchase or install transmission
equipment (other than such equipment used by
qualified mental health professionals to
deliver mental health services using telehealth
under the project involved); or
(B) build upon or acquire real property.
(d) Equitable Distribution.--In awarding grants under this
section, the Secretary shall ensure, to the greatest extent
possible, that such grants are equitably distributed among
geographical regions of the United States.
(e) Application.--An entity that desires a grant under this
section shall submit an application to the Secretary at such
time, in such manner, and containing such information as the
Secretary determines to be reasonable.
(f) Report.--Not later than 4 years after the date of
enactment of the Health Care Safety Net Amendments of 2002, the
Secretary shall prepare and submit to the appropriate
committees of Congress a report that shall evaluate activities
funded with grants under this section.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $20,000,000 for
fiscal year 2002 and such sums as may be necessary for fiscal
years 2003 through 2006.
SEC. 330L. [254C-18] TELEMEDICINE; INCENTIVE GRANTS REGARDING
COORDINATION AMONG STATES.
(a) In General.--The Secretary may make grants to State
professional licensing boards to carry out programs under which
such licensing boards of various States cooperate to develop
and implement State policies that will reduce statutory and
regulatory barriers to telemedicine.
(b) Authorization of Appropriations.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.
Subpart II--National Health Service Corps Program
national health service corps
Sec. 331. [254d] (a)(1) For the purpose of eliminating
health manpower \1\ shortages in health professional shortage
areas, there is established, within the Service, the National
Health Service Corps, which shall consist of--
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\1\ So in law. Probably should be ``health professional
shortages''. See section 401 of Public Law 101-597 (104 Stat. 3035).
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(A) such officers of the Regular and Reserve Corps
of the Service as the Secretary may designate,
(B) such civilian employees of the United States as
the Secretary may appoint, and
(C) such other individuals who are not employees of
the United States.
(2) The Corps shall be utilized by the Secretary to provide
primary health services in health professional shortage areas.
(3) For purposes of this subpart and subpart III:
(A) The term ``Corps'' means the National Health
Service Corps.
(B) The term ``Corps member'' means each of the
officers, employees, and individuals of which the Corps
consists pursuant to paragraph (1).
(C) The term ``health professional shortage area''
has the meaning given such term in section 332(a).
(D) The term ``primary health services'' means
health services regarding family medicine, internal
medicine, pediatrics, obstetrics and gynecology,
dentistry, or mental health, that are provided by
physicians or other health professionals.
(E)(i) The term ``behavioral and mental health
professionals'' means health service psychologists,
licensed clinical social workers, licensed professional
counselors, marriage and family therapists, psychiatric
nurse specialists, and psychiatrists.
(ii) The term `graduate program of behavioral and
mental health' means a program that trains behavioral
and mental health professionals.
(b)(1) The Secretary may conduct at schools of medicine,
osteopathic medicine, dentistry, and, as appropriate, nursing
and other schools of the health professions, including schools
at which graduate programs of behavioral and mental health are
offered, and at entities which train allied health personnel,
recruiting programs for the Corps, the Scholarship Program, and
the Loan Repayment Program. Such recruiting programs shall
include efforts to recruit individuals who will serve in the
Corps other than pursuant to obligated service under the
Scholarship or Loan Repayment Program.
(2) In the case of physicians, dentists, behavioral and
mental health professionals, certified nurse midwives,
certified nurse practitioners, and physician assistants who
have an interest and a commitment to providing primary health
care, the Secretary may establish fellowship programs to enable
such health professionals to gain exposure to and expertise in
the delivery of primary health services in health professional
shortage areas. To the maximum extent practicable, the
Secretary shall ensure that any such programs are established
in conjunction with accredited residency programs, and other
training programs, regarding such health professions.
(c)(1) The Secretary may reimburse an applicant for a
position in the Corps (including an individual considering
entering into a written agreement pursuant to section 338D) for
the actual and reasonable expenses incurred in traveling to and
from the applicant's place of residence to an eligible site to
which the applicant may be assigned under section 333 for the
purpose of evaluating such site with regard to being assigned
at such site. The Secretary may establish a maximum total
amount that may be paid to an individual as reimbursement for
such expenses.
(2) The Secretary may also reimburse the applicant for the
actual and reasonable expenses incurred for the travel of 1
family member to accompany the applicant to such site. The
Secretary may establish a maximum total amount that may be paid
to an individual as reimbursement for such expenses.
(3) In the case of an individual who has entered into a
contract for obligated service under the Scholarship Program or
under the Loan Repayment Program, the Secretary may reimburse
such individual for all or part of the actual and reasonable
expenses incurred in transporting the individual, the
individual's family, and the family's possessions to the site
of the individual's assignment under section 333. The Secretary
may establish a maximum total amount that may be paid to an
individual as reimbursement for such expenses.
(d)(1) The Secretary may, under regulations promulgated by
the Secretary, adjust the monthly pay of each member of the
Corps (other than a member described in subsection (a)(1)(C))
who is directly engaged in the delivery of health services in a
health professional shortage area as follows:
(A) During the first 36 months in which such a
member is so engaged in the delivery of health
services, his monthly pay may be increased by an amount
which when added to the member's monthly pay and
allowances will provide a monthly income competitive
with the average monthly income from a practice of an
individual who is a member of the profession of the
Corps member, who has equivalent training, and who has
been in practice for a period equivalent to the period
during which the Corps member has been in practice.
(B) During the period beginning upon the expiration
of the 36 months referred to in subparagraph (A) and
ending with the month in which the member's monthly pay
and allowances are equal to or exceed the monthly
income he received for the last of such 36 months, the
member may receive in addition to his monthly pay and
allowances an amount which when added to such monthly
pay and allowances equals the monthly income he
received for such last month.
(C) For each month in which a member is directly
engaged in the delivery of health services in a health
professional shortage area in accordance with an
agreement with the Secretary entered into under section
741(f)(1)(C), under which the Secretary is obligated to
make payments in accordance with section 741(f)(2), the
amount of any monthly increase under subparagraph (A)
or (B) with respect to such member shall be decreased
by an amount equal to one-twelfth of the amount which
the Secretary is obligated to pay upon the completion
of the year of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the term ``monthly
pay'' includes special pay received under chapter 5 of title 37
of the United States Code.
(2) In the case of a member of the Corps who is directly
engaged in the delivery of health services in a health
professional shortage area in accordance with a service
obligation incurred under the Scholarship Program or the Loan
Repayment Program, the adjustment in pay authorized by
paragraph (1) may be made for such a member only upon
satisfactory completion of such service obligation, and the
first 36 months of such member's being so engaged in the
delivery of health services shall, for purposes of paragraph
(1)(A), be deemed to begin upon such satisfactory completion.
(3) A member of the Corps described in subparagraph (C) of
subsection (a)(1) shall when assigned to an entity under
section 333 be subject to the personnel system of such entity,
except that such member shall receive during the period of
assignment the income that the member would receive if the
member was a member of the Corps described in subparagraph (B)
of such subsection.
(e) Corps members assigned under section 333 to provide
health services in health professional shortage areas shall not
be counted against any employment ceiling affecting the
Department.
(f) Sections 214 and 216 shall not apply to members of the
National Health Service Corps during their period of obligated
service under the Scholarship Program or the Loan Repayment
Program, except when such members are Commissioned Corps
officers who entered into a contract with Secretary under
section 338A or 338B after December 31, 2006 and when the
Secretary determines that exercising the authority provided
under section 214 or 216 with respect to any such officer to
would not cause unreasonable disruption to health care services
provided in the community in which such officer is providing
health care services.
(g)(1) The Secretary shall, by rule, prescribe conversion
provisions applicable to any individual who, within a year
after completion of service as a member of the Corps described
in subsection (a)(1)(C), becomes a commissioned officer in the
Regular or Reserve Corps of the Service.
(2) The rules prescribed under paragraph (1) shall provide
that in applying the appropriate provisions of this Act which
relate to retirement, any individual who becomes such an
officer shall be entitled to have credit for any period of
service as a member of the Corps described in subsection
(a)(1)(C).
(h) The Secretary shall ensure that adequate staff is
provided to the Service with respect to effectively
administering the program for the Corps.
(i)(1) In carrying out subpart III, the Secretary may, in
accordance with this subsection, issue waivers to individuals
who have entered into a contract for obligated service under
the Scholarship Program or the Loan Repayment Program under
which the individuals are authorized to satisfy the requirement
of obligated service through providing clinical practice that
is half time.
(2) A waiver described in paragraph (1) may be provided by
the Secretary only if--
(A) the entity for which the service is to be
performed--
(i) has been approved under section 333A
for assignment of a Corps member; and
(ii) has requested in writing assignment of
a health professional who would serve half
time;
(B) the Secretary has determined that assignment of
a health professional who would serve half time would
be appropriate for the area where the entity is
located;
(C) a Corps member who is required to perform
obligated service has agreed in writing to be assigned
for half-time service to an entity described in
subparagraph (A);
(D) the entity and the Corps member agree in
writing that the Corps member will perform half-time
clinical practice;
(E) the Corps member agrees in writing to fulfill
all of the service obligations under section 338C
through half-time clinical practice and either--
(i) double the period of obligated service
that would otherwise be required; or
(ii) in the case of contracts entered into
under section 338B, accept a minimum service
obligation of 2 years with an award amount
equal to 50 percent of the amount that would
otherwise be payable for full-time service; and
(F) the Corps member agrees in writing that if the
Corps member begins providing half-time service but
fails to begin or complete the period of obligated
service, the method stated in 338E(c) for determining
the damages for breach of the individual's written
contract will be used after converting periods of
obligated service or of service performed into their
full-time equivalents.
(3) In evaluating waivers issued under paragraph (1), the
Secretary shall examine the effect of multidisciplinary teams.
(j) For the purposes of this subpart and subpart III:
(1) The term ``Department'' means the Department of
Health and Human Services.
(2) The term ``Loan Repayment Program'' means the
National Health Service Corps Loan Repayment Program
established under section 338B.
(3) The term ``Scholarship Program'' means the
National Health Service Corps Scholarship Program
established under section 338A.
(4) The term ``State'' includes, in addition to the
several States, only the District of Columbia, the
Commonwealth of Puerto Rico, the Commonwealth of the
Northern Mariana Islands, the Virgin Islands, Guam,
American Samoa, and the Trust Territory of the Pacific
Islands.
(5) The terms ``full time'' and ``full-time'' mean
a minimum of 40 hours per week in a clinical practice,
for a minimum of 45 weeks per year.
(6) The terms ``half time'' and ``half-time'' mean
a minimum of 20 hours per week (not to exceed 39 hours
per week) in a clinical practice, for a minimum of 45
weeks per year.
designation of health professional shortage areas
Sec. 332. [254e] (a)(1) For purposes of this subpart the
term ``health professional shortage area'' means (A) an area in
an urban or rural area (which need not conform to the
geographic boundaries of a political subdivision and which is a
rational area for the delivery of health services) which the
Secretary determines has a health manpower shortage, (B) a
population group which the Secretary determines has such a
shortage, or (C) a public or nonprofit private medical facility
or other public facility which the Secretary determines has
such a shortage. All Federally qualified health centers and
rural health clinics, as defined in section 1861(aa) of the
Social Security Act (42 U.S.C. 1395x(aa)), that meet the
requirements of section 334 shall be automatically designated
as having such a shortage. The Secretary shall not remove an
area from the areas determined to be health professional
shortage areas under subparagraph (A) of the preceding sentence
until the Secretary has afforded interested persons and groups
in such area an opportunity to provide data and information in
support of the designation as a health professional shortage
area or a population group described in subparagraph (B) of
such sentence or a facility described in subparagraph (C) of
such sentence, and has made a determination on the basis of the
data and information submitted by such persons and groups and
other data and information available to the Secretary.
(2) For purposes of this subsection, the term ``medical
facility'' means a facility for the delivery of health services
and includes--
(A) a hospital, State mental hospital, public
health center, outpatient medical facility,
rehabilitation facility, facility for long-term care,
community mental health center, migrant health center,
facility operated by a city or county health
department, and community health center and which is
not reasonably accessible to an adequately served area;
(B) such a facility of a State correctional
institution or of the Indian Health Service, and a
health program or facility operated by a tribe or
tribal organization under the Indian Self-Determination
Act;
(C) such a facility used in connection with the
delivery of health services under section 321 (relating
to hospitals), 322 (relating to care and treatment of
persons under quarantine and others), 323 (relating to
care and treatment of Federal prisoners), 324 (relating
to examination and treatment of certain Federal
employees), 325 (relating to examination of aliens),
326 (relating to services to certain Federal
employees), 320 (relating to services for persons with
Hansen's disease), or 330(h) (relating to the provision
of health services to homeless individuals); and
(D) a Federal medical facility.
(3) Homeless individuals (as defined in section 330(h)(5)),
seasonal agricultural workers (as defined in section 330(g)(3))
and migratory agricultural workers (as so defined)), and
residents of public housing (as defined in section 3(b)(1) of
the United States Housing Act of 1937 (42 U.S.C. 1437a(b)(1)))
may be population groups under paragraph (1).
(b) The Secretary shall establish by regulation criteria
for the designation of areas, population groups, medical
facilities, and other public facilities, in the States, as
health professional shortage areas. In establishing such
criteria, the Secretary shall take into consideration the
following:
(1) The ratio of available health manpower to the
number of individuals in an area or population group,
or served by a medical facility or other public
facility under consideration for designation.
(2) Indicators of a need, notwithstanding the
supply of health manpower, for health services for the
individuals in an area or population group or served by
a medical facility or other public facility under
consideration for designation.
(3) The percentage of physicians serving an area,
population group, medical facility, or other public
facility under consideration for designation who are
employed by hospitals and who are graduates of foreign
medical schools.
(c) In determining whether to make a designation, the
Secretary shall take into consideration the following:
(1) The recommendations of the Governor of each
State in which the area, population group, medical
facility, or other public facility under consideration
for designation is in whole or part located.
(2) The extent to which individuals who are (A)
residents of the area, members of the population group,
or patients in the medical facility or other public
facility under consideration for designation, and (B)
entitled to have payment made for medical services
under title XVIII, XIX, or XXI of the Social Security
Act, cannot obtain such services because of suspension
of physicians from the programs under such titles.
(d)(1) In accordance with the criteria established under
subsection (b) and the considerations listed in subsection (c),
the Secretary shall designate health professional shortage
areas in the States, publish a descriptive list of the areas,
population groups, medical facilities, and other public
facilities so designated, and at least annually review and, as
necessary, revise such designations.
(2) For purposes of paragraph (1), a complete descriptive
list shall be published in the Federal Register not later than
July 1 of 1991 and each subsequent year.
(e)(1) Prior to the designation of a public facility,
including a Federal medical facility, as a health professional
shortage area, the Secretary shall give written notice of such
proposed designation to the chief administrative officer of
such facility and request comments within 30 days with respect
to such designation.
(2) Prior to the designation of a health professional
shortage area under this section, the Secretary shall, to the
extent practicable, give written notice of the proposed
designation of such area to appropriate public or private
nonprofit entities which are located or have a demonstrated
interest in such area and request comments from such entities
with respect to the proposed designation of such area.
(f) The Secretary shall give written notice of the
designation of a health professional shortage area, not later
than 60 days from the date of such designation, to--
(1) the Governor of each State in which the area,
population group, medical facility, or other public
facility so designated is in whole or part located; and
(2) appropriate public or nonprofit private
entities which are located or which have a demonstrated
interest in the area so designated.
(g) Any person may recommend to the Secretary the
designation of an area, population group, medical facility, or
other public facility as a health professional shortage area.
(h) The Secretary may conduct such information programs in
areas, among population groups, and in medical facilities and
other public facilities designated under this section as health
professional shortage areas as may be necessary to inform
public and nonprofit private entities which are located or have
a demonstrated interest in such areas of the assistance
available under this title by virtue of the designation of such
areas.
(i) Dissemination.--The Administrator of the Health
Resources and Services Administration shall disseminate
information concerning the designation criteria described in
subsection (b) to--
(1) the Governor of each State;
(2) the representative of any area, population
group, or facility selected by any such Governor to
receive such information;
(3) the representative of any area, population
group, or facility that requests such information; and
(4) the representative of any area, population
group, or facility determined by the Administrator to
be likely to meet the criteria described in subsection
(b).
(j)(1) The Secretary shall submit the report described in
paragraph (2) if the Secretary, acting through the
Administrator of the Health Resources and Services
Administration, issues--
(A) a regulation that revises the definition of a
health professional shortage area for purposes of this
section; or
(B) a regulation that revises the standards
concerning priority of such an area under section 333A.
(2) On issuing a regulation described in paragraph (1), the
Secretary shall prepare and submit to the Committee on Energy
and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate a
report that describes the regulation.
(3) Each regulation described in paragraph (1) shall take
effect 180 days after the committees described in paragraph (2)
receive a report referred to in such paragraph describing the
regulation.
assignment of corps personnel
Sec. 333. [254f] (a)(1) The Secretary may assign members of
the Corps to provide, under regulations promulgated by the
Secretary, health services in or to a health professional
shortage area during the assignment period only if--
(A) a public or private entity, which is located or
has a demonstrated interest in such area, makes
application to the Secretary for such assignment;
(B) such application has been approved by the
Secretary;
(C) the entity agrees to comply with the
requirements of section 334; and
(D) the Secretary has (i) conducted an evaluation
of the need and demand for health professional shortage
area, the intended use of Corps members to be assigned
to the area, community support for the assignment of
Corps members to the area, the area's efforts to secure
health professional shortage area, and the fiscal
management capability of the entity to which Corps
members would be assigned and (ii) on the basis of such
evaluation has determined that--
(I) there is a need and demand for health
manpower for the area;
(II) there has been appropriate and
efficient use of any Corps members previously
assigned to the entity for the area;
(III) there is general community support
for the assignment of Corps members to the
entity;
(IV) the area has made unsuccessful efforts
to secure health manpower for the area;
(V) there is a reasonable prospect of sound
fiscal management, including efficient
collection of fee-for-service, third-party, and
other appropriate funds, by the entity with
respect to Corps members assigned to such
entity; and
(VI) \1\ the entity
demonstrates willingness to
support or facilitate
mentorship, professional
development, and training
opportunities for Corps
members.
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\1\ Margin so in law.
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An application for assignment of a Corps member to a health
professional shortage area shall include a demonstration by the
applicant that the area or population group to be served by the
applicant has a shortage of personal health services and that
the Corps member will be located so that the member will
provide services to the greatest number of persons residing in
such area or included in such population group. Such a
demonstration shall be made on the basis of the criteria
prescribed by the Secretary under section 332(b) and on
additional criteria which the Secretary shall prescribe to
determine if the area or population group to be served by the
applicant has a shortage of personal health services.
(2) Corps members may be assigned to a Federal health care
facility, but only upon the request of the head of the
department or agency of which such facility is a part.
(3) In approving applications for assignment of members of
the Corps the Secretary shall not discriminate against
applications from entities which are not receiving Federal
financial assistance under this Act. In approving such
applications, the Secretary shall give preference to
applications in which a nonprofit entity or public entity shall
provide a site to which Corps members may be assigned.
(b)(1) The Secretary may not approve an application for the
assignment of a member of the Corps described in subparagraph
(C) of section 331(a)(1) to an entity unless the application of
the entity contains assurances satisfactory to the Secretary
that the entity (A) has sufficient financial resources to
provide the member of the Corps with an income of not less than
the income to which the member would be entitled if the member
was a member described in subparagraph (B) of section
331(a)(1), or (B) would have such financial resources if a
grant was made to the entity under paragraph (2).
(2)(A) If in approving an application of an entity for the
assignment of a member of the Corps described in subparagraph
(C) of section 331(a)(1) the Secretary determines that the
entity does not have sufficient financial resources to provide
the member of the Corps with an income of not less than the
income to which the member would be entitled if the member was
a member described in subparagraph (B) of section 331(a)(1),
the Secretary may make a grant to the entity to assure that the
member of the Corps assigned to it will receive during the
period of assignment to the entity such an income.
(B) The amount of any grant under subparagraph (A) shall be
determined by the Secretary. Payments under such a grant may be
made in advance or by way of reimbursement, and at such
intervals and on such conditions, as the Secretary finds
necessary. No grant may be made unless an application therefor
is submitted to and approved by the Secretary. Such an
application shall be in such form, submitted in such manner,
and contain such information, as the Secretary shall by
regulation prescribe.
(c) The Secretary shall assign Corps members to entities in
health professional shortage areas without regard to the
ability of the individuals in such areas, population groups,
medical facilities, or other public facilities to pay for such
services.
(d)(1) The Secretary may provide technical assistance to a
public or private entity which is located in a health
professional shortage area and which desires to make an
application under this section for assignment of a Corps member
to such area. Assistance provided under this paragraph may
include assistance to an entity in (A) analyzing the potential
use of health professions personnel in defined health services
delivery areas by the residents of such areas, (B) determining
the need for such personnel in such areas, (C) determining the
extent to which such areas will have a financial base to
support the practice of such personnel and the extent to which
additional financial resources are needed to adequately support
the practice, (D) determining the types of inpatient and other
health services that should be provided by such personnel in
such areas, and (E) developing long-term plans for addressing
health professional shortages and improving access to health
care. The Secretary shall encourage entities that receive
technical assistance under this paragraph to communicate with
other communities, State Offices of Rural Health, State Primary
Care Associations and Offices, and other entities concerned
with site development and community needs assessment.
(2) The Secretary may provide, to public and private
entities which are located in a health professional shortage
area to which area a Corps member has been assigned, technical
assistance to assist in the retention of such member in such
area after the completion of such member's assignment to the
area.
(3) The Secretary may provide, to health professional
shortage areas to which no Corps member has been assigned, (A)
technical assistance to assist in the recruitment of health
manpower for such areas, and (B) current information on public
and private programs which provide assistance in the securing
of health manpower.
(4)(A) The Secretary shall undertake to demonstrate the
improvements that can be made in the assignment of members of
the Corps to health professional shortage areas and in the
delivery of health care by Corps members in such areas through
coordination with States, political subdivisions of States,
agencies of States and political subdivisions, and other public
and private entities which have expertise in the planning,
development, and operation of centers for the delivery of
primary health care. In carrying out this subparagraph, the
Secretary shall enter into agreements with qualified entities
which provide that if--
(i) the entity places in effect a program for the
planning, development, and operation of centers for the
delivery of primary health care in health professional
shortage areas which reasonably addresses the need for
such care in such areas, and
(ii) under the program the entity will perform the
functions described in subparagraph (B),
the Secretary will assign under this section members of the
Corps in accordance with the program.
(B) For purposes of subparagraph (A), the term ``qualified
entity'' means a State, political subdivision of a State, an
agency of a State or political subdivision, or other public or
private entity operating solely within one State, which the
Secretary determines is able--
(i) to analyze the potential use of health
professions personnel in defined health services
delivery areas by the residents of such areas;
(ii) to determine the need for such personnel in
such areas and to recruit, select, and retain health
professions personnel (including members of the
National Health Service Corps) to meet such need;
(iii) to determine the extent to which such areas
will have a financial base to support the practice of
such personnel and the extent to which additional
financial resources are needed to adequately support
the practice;
(iv) to determine the types of inpatient and other
health services that should be provided by such
personnel in such areas;
(v) to assist such personnel in the development of
their clinical practice and fee schedules and in the
management of their practice;
(vi) to assist in the planning and development of
facilities for the delivery of primary health care; and
(vii) to assist in establishing the governing
bodies of centers for the delivery of such care and to
assist such bodies in defining and carrying out their
responsibilities.
(e) Notwithstanding any other law, any member of the Corps
licensed to practice medicine, osteopathic medicine, dentistry,
or any other health profession in any State shall, while
serving in the Corps, be allowed to practice such profession in
any State.
SEC. 333A. [254F-1] PRIORITIES IN ASSIGNMENT OF CORPS PERSONNEL.
(a) In General.--In approving applications made under
section 333 for the assignment of Corps members, the Secretary
shall--
(1) give priority to any such application that--
(A) is made regarding the provision of
primary health services to a health
professional shortage area with the greatest
such shortage; and
(B) is made by an entity that--
(i) serves a health professional
shortage area described in subparagraph
(A);
(ii) coordinates the delivery of
primary health services with related
health and social services;
(iii) has a documented record of
sound fiscal management; and
(iv) will experience a negative
impact on its capacity to provide
primary health services if a Corps
member is not assigned to the entity;
(2) with respect to the geographic area in which
the health professional shortage area is located, take
into consideration the willingness of individuals in
the geographic area, and of the appropriate
governmental agencies or health entities in the area,
to assist and cooperate with the Corps in providing
effective primary health services; and
(3) take into consideration comments of medical,
osteopathic, dental, or other health professional
societies whose members deliver services to the health
professional shortage area, or if no such societies
exist, comments of physicians, dentists, or other
health professionals delivering services to the area.
(b) Establishment of Criteria for Determining Priorities.--
(1) In general.--The Secretary shall establish
criteria specifying the manner in which the Secretary
makes a determination under subsection (a)(1)(A) of the
health professional shortage areas with the greatest
such shortages.
(2) Publication of criteria.--The criteria required
in paragraph (1) shall be published in the Federal
Register not later than July 1, 1991. Any revisions
made in the criteria by the Secretary shall be
effective upon publication in the Federal Register.
(c) Notifications Regarding Priorities.--
(1) Proposed list.--The Secretary shall prepare and
publish a proposed list of health professional shortage
areas and entities that would receive priority under
subsection (a)(1) in the assignment of Corps members.
The list shall contain the information described in
paragraph (2), and the relative scores and relative
priorities of the entities submitting applications
under section 333, in a proposed format. All such
entities shall have 30 days after the date of
publication of the list to provide additional data and
information in support of inclusion on the list or in
support of a higher priority determination and the
Secretary shall reasonably consider such data and
information in preparing the final list under paragraph
(2).
(2) Preparation of list for applicable period.--For
the purpose of carrying out paragraph (3), the
Secretary shall prepare and, as appropriate, update a
list of health professional shortage areas and entities
that are receiving priority under subsection (a)(1) in
the assignment of Corps members. Such list--
(A) shall include a specification, for each
such health professional shortage area, of the
entities for which the Secretary has provided
an authorization to receive assignments of
Corps members in the event that Corps members
are available for the assignments; and
(B) shall, of the entities for which an
authorization described in subparagraph (A) has
been provided, specify--
(i) the entities provided such an
authorization for the assignment of
Corps members who are participating in
the Scholarship Program;
(ii) the entities provided such an
authorization for the assignment of
Corps members who are participating in
the Loan Repayment Program; and
(iii) the entities provided such an
authorization for the assignment of
Corps members who have become Corps
members other than pursuant to
contractual obligations under the
Scholarship or Loan Repayment Programs.
The Secretary may set forth such specifications
by medical specialty.
(3) Notification of affected parties.--
(A) Entities.--Not later than 30 days after
the Secretary has added to a list under
paragraph (2) an entity specified as described
in subparagraph (A) of such paragraph, the
Secretary shall notify such entity that the
entity has been provided an authorization to
receive assignments of Corps members in the
event that Corps members are available for the
assignments.
(B) Individuals.--In the case of an
individual obligated to provide service under
the Scholarship Program, not later than 3
months before the date described in section
338C(b)(5), the Secretary shall provide to such
individual the names of each of the entities
specified as described in paragraph (2)(B)(i)
that is appropriate for the individual's
medical specialty and discipline.
(4) Revisions.--If the Secretary proposes to make a
revision in the list under paragraph (2), and the
revision would adversely alter the status of an entity
with respect to the list, the Secretary shall notify
the entity of the revision. Any entity adversely
affected by such a revision shall be notified in
writing by the Secretary of the reasons for the
revision and shall have 30 days from such notification
to file a written appeal of the determination involved
which shall be reasonably considered by the Secretary
before the revision to the list becomes final. The
revision to the list shall be effective with respect to
assignment of Corps members beginning on the date that
the revision becomes final.
(d) Limitation on Number of Entities Offered as Assignment
Choices in Scholarship Program.--
(1) Determination of available corps members.--By
April 1 of each calendar year, the Secretary shall
determine the number of participants in the Scholarship
Program who will be available for assignments under
section 333 during the program year beginning on July 1
of that calendar year.
(2) Determination of number of entities.--At all
times during a program year, the number of entities
specified under subsection (c)(2)(B)(i) shall be--
(A) not less than the number of
participants determined with respect to that
program year under paragraph (1); and
(B) not greater than twice the number of
participants determined with respect to that
program year under paragraph (1).
SEC. 334. [254G] CHARGES FOR SERVICES BY ENTITIES USING CORPS MEMBERS.
(a) Availability of Services Regardless of Ability To Pay
or Payment Source.--An entity to which a Corps member is
assigned shall not deny requested health care services, and
shall not discriminate in the provision of services to an
individual--
(1) because the individual is unable to pay for the
services; or
(2) because payment for the services would be made
under--
(A) the medicare program under title XVIII
of the Social Security Act (42 U.S.C. 1395 et
seq.);
(B) the medicaid program under title XIX of
such Act (42 U.S.C. 1396 et seq.); or
(C) the State children's health insurance
program under title XXI of such Act (42 U.S.C.
1397aa et seq.).
(b) Charges for Services.--The following rules shall apply
to charges for health care services provided by an entity to
which a Corps member is assigned:
(1) In general.--
(A) Schedule of fees or payments.--Except
as provided in paragraph (2), the entity shall
prepare a schedule of fees or payments for the
entity's services, consistent with locally
prevailing rates or charges and designed to
cover the entity's reasonable cost of
operation.
(B) Schedule of discounts.--Except as
provided in paragraph (2), the entity shall
prepare a corresponding schedule of discounts
(including, in appropriate cases, waivers) to
be applied to the payment of such fees or
payments. In preparing the schedule, the entity
shall adjust the discounts on the basis of a
patient's ability to pay.
(C) Use of schedules.--The entity shall
make every reasonable effort to secure from
patients fees and payments for services in
accordance with such schedules, and fees or
payments shall be sufficiently discounted in
accordance with the schedule described in
subparagraph (B).
(2) Services to beneficiaries of federal and
federally assisted programs.--In the case of health
care services furnished to an individual who is a
beneficiary of a program listed in subsection (a)(2),
the entity--
(A) shall accept an assignment pursuant to
section 1842(b)(3)(B)(ii) of the Social
Security Act (42 U.S.C. 1395u(b)(3)(B)(ii))
with respect to an individual who is a
beneficiary under the medicare program; and
(B) shall enter into an appropriate
agreement with--
(i) the State agency administering
the program under title XIX of such Act
with respect to an individual who is a
beneficiary under the medicaid program;
and
(ii) the State agency administering
the program under title XXI of such Act
with respect to an individual who is a
beneficiary under the State children's
health insurance program.
(3) Collection of payments.--The entity shall take
reasonable and appropriate steps to collect all
payments due for health care services provided by the
entity, including payments from any third party
(including a Federal, State, or local government agency
and any other third party) that is responsible for part
or all of the charge for such services.
provision of health services by corps members
Sec. 335. [254h] (a) In providing health services in a
health professional shortage area, Corps members shall utilize
the techniques, facilities, and organizational forms most
appropriate for the area, population group, medical facility,
or other public facility, and shall, to the maximum extent
feasible, provide such services (1) to all individuals in, or
served by, such health professional shortage area regardless of
their ability to pay for the services, and (2) in a manner
which is cooperative with other health care providers serving
such health professional shortage area.
(b)(1) Notwithstanding any other provision of law, the
Secretary may (A) to the maximum extent feasible make such
arrangements as he determines necessary to enable Corps members
to utilize the health facilities in or serving the health
professional shortage area in providing health services; (B)
make such arrangements as he determines are necessary for the
use of equipment and supplies of the Service and for the lease
or acquisition of other equipment and supplies; and (C) secure
the permanent or temporary services of physicians, dentists,
nurses, administrators, and other health personnel. If there
are no health facilities in or serving such area, the Secretary
may arrange to have Corps members provide health services in
the nearest health facilities of the Service or may lease or
otherwise provide facilities in or serving such area for the
provision of health services.
(2) If the individuals in or served by a health
professional shortage area are being served (as determined
under regulations of the Secretary) by a hospital or other
health care delivery facility of the Service, the Secretary
may, in addition to such other arrangements as he may make
under paragraph (1), arrange for the utilization of such
hospital or facility by Corps members in providing health
services, but only to the extent that such utilization will not
impair the delivery of health services and treatment through
such hospital or facility to individuals who are entitled to
health services and treatment through such hospital or
facility.
(c) The Secretary may make one loan to any entity with an
approved application under section 333 to assist such entity in
meeting the costs of (1) establishing medical, dental, or other
health profession practices, including the development of
medical practice management systems; (2) acquiring equipment
for use in providing health services; and (3) renovating
buildings to establish health facilities. No loan may be made
under this subsection unless an application therefor is
submitted to, and approved by, the Secretary. The amount of any
such loan shall be determined by the Secretary, except that no
such loan may exceed $50,000.
(d) Upon the expiration of the assignment of all Corps
members to a health professional shortage area, the Secretary
may (notwithstanding any other provision of law) sell, to any
appropriate local entity, equipment and other property of the
United States utilized by such members in providing health
services. Sales made under this subsection shall be made at the
fair market value (as determined by the Secretary) of the
equipment or such other property; except that the Secretary may
make such sales for a lesser value to an appropriate local
entity, if he determines that the entity is financially unable
to pay the full market value.
(e)(1)(A) It shall be unlawful for any hospital to deny an
authorized Corps member admitting privileges when such Corps
member otherwise meets the professional qualifications
established by the hospital for granting such privileges and
agrees to abide by the published bylaws of the hospital and the
published bylaws, rules, and regulations of its medical staff.
(B) Any hospital which is found by the Secretary, after
notice and an opportunity for a hearing on the record, to have
violated this subsection shall upon such finding cease, for a
period to be determined by the Secretary, to receive and to be
eligible to receive any Federal funds under this Act or under
titles XVIII, XIX, or XXI of the Social Security Act.
(2) For purposes of this subsection, the term ``hospital''
includes a State or local public hospital, a private profit
hospital, a private nonprofit hospital, a general or special
hospital, and any other type of hospital (excluding a hospital
owned or operated by an agency of the Federal Government), and
any related facilities.
SEC. 336. [254H-1] FACILITATION OF EFFECTIVE PROVISION OF CORPS
SERVICES.
(a) Consideration of Individual Characteristics of Members
in Making Assignments.--In making an assignment of a Corps
member to an entity that has had an application approved under
section 333, the Secretary shall, subject to making the
assignment in accordance with section 333A, seek to assign to
the entity a Corps member who has (and whose spouse, if any,
has) characteristics that increase the probability that the
member will remain in the health professional shortage area
involved after the completion of the period of service in the
Corps.
(b) Counseling on Service in Corps.--
(1) In general.--The Secretary shall, subject to
paragraph (3), offer appropriate counseling on service
in the Corps to individuals during the period of
membership in the Corps, particularly during the
initial period of each assignment.
(2) Career advisor regarding obligated service.--
(A) In the case of individuals who have
entered into contracts for obligated service
under the Scholarship or Loan Repayment
Program, counseling under paragraph (1) shall
include appropriate counseling on matters
particular to such obligated service. The
Secretary shall ensure that career advisors for
providing such counseling are available to such
individuals throughout the period of
participation in the Scholarship or Loan
Repayment Program.
(B) With respect to the Scholarship
Program, counseling under paragraph (1) shall
include counseling individuals during the
period in which the individuals are pursuing an
educational degree in the health profession
involved, including counseling to prepare the
individual for service in the Corps.
(3) Extent of counseling services.--With respect to
individuals who have entered into contracts for
obligated service under the Scholarship or Loan
Repayment Program, this subsection shall be carried out
regarding such individuals throughout the period of
obligated service (and, additionally, throughout the
period specified in paragraph (2)(B), in the case of
the Scholarship Program). With respect to Corps members
generally, this subsection shall be carried out to the
extent practicable.
(c) Grants Regarding Preparation of Students for
Practice.--With respect to individuals who have entered into
contracts for obligated service under the Scholarship or Loan
Repayment Program, the Secretary may make grants to, and enter
into contracts with, public and nonprofit private entities
(including health professions schools) for the conduct of
programs designed to prepare such individuals for the effective
provision of primary health services in the health professional
shortage areas to which the individuals are assigned.
(d) Professional Development and Training.--
(1) In general.--The Secretary shall assist Corps
members in establishing and maintaining professional
relationships and development opportunities, including
by--
(A) establishing appropriate professional
relationships between the Corps member involved
and the health professions community of the
geographic area with respect to which the
member is assigned;
(B) establishing professional development,
training, and mentorship linkages between the
Corps member involved and the larger health
professions community, including through
distance learning, direct mentorship, and
development and implementation of training
modules designed to meet the educational needs
of offsite Corps members;
(C) establishing professional networks
among Corps members; or
(D) engaging in other professional
development, mentorship, and training
activities for Corps members, at the discretion
of the Secretary.
(2) Assistance in establishing professional
relationships.--In providing such assistance under
paragraph (1), the Secretary shall focus on
establishing relationships with hospitals, with
academic medical centers and health professions
schools, with area health education centers under
section 751, with health education and training centers
under section 752, and with border health education and
training centers under such section 752. Such
assistance shall include assistance in obtaining
faculty appointments at health professions schools.
(3) Supplement not supplant.--Such efforts under
this subsection shall supplement, not supplant, non-
government efforts by professional health provider
societies to establish and maintain professional
relationships and development opportunities.
(e) Temporary Relief From Corps Duties.--
(1) In general.--The Secretary shall, subject to
paragraph (4), provide assistance to Corps members in
establishing arrangements through which Corps members
may, as appropriate, be provided temporary relief from
duties in the Corps in order to pursue continuing
education in the health professions, to participate in
exchange programs with teaching centers, to attend
professional conferences, or to pursue other interests,
including vacations.
(2) Assumption of duties of member.--
(A) Temporary relief under paragraph (1)
may be provided only if the duties of the Corps
member involved are assumed by another health
professional. With respect to such temporary
relief, the duties may be assumed by Corps
members or by health professionals who are not
Corps members, if the Secretary approves the
professionals for such purpose. Any health
professional so approved by the Secretary
shall, during the period of providing such
temporary relief, be deemed to be a Corps
member for purposes of section 224 (including
for purposes of the remedy described in such
section), section 333(f) \1\, and section
335(e).
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\1\ So in law. As a result of the amendments made by section 103(b)
of Public Law 101-597 (104 Stat. 3015), there is no subsection (f) in
section 333. (Subsection (e) of section 333, like sections 224 and
335(e), establishes a right for Corps members.)
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(B) In carrying out paragraph (1), the
Secretary shall provide for the formation and
continued existence of a group of health
professionals to provide temporary relief under
such paragraph.
(3) Recruitment from general health professions
community.--In carrying out paragraph (1), the
Secretary shall--
(A) encourage health professionals who are
not Corps members to enter into arrangements
under which the health professionals
temporarily assume the duties of Corps members
for purposes of paragraph (1); and
(B) with respect to the entities to which
Corps members have been assigned under section
333, encourage the entities to facilitate the
development of arrangements described in
subparagraph (A).
(4) Limitation.--In carrying out paragraph (1), the
Secretary may not, except as provided in paragraph (5),
obligate any amounts (other than for incidental
expenses) for the purpose of--
(A) compensating a health professional who
is not a Corps member for assuming the duties
of a Corps member; or
(B) paying the costs of a vacation, or
other interests that a Corps member may pursue
during the period of temporary relief under
such paragraph.
(5) Sole providers of health services.--In the case
of any Corps member who is the sole provider of health
services in the geographic area involved, the Secretary
may, from amounts appropriated under section 338,
obligate on behalf of the member such sums as the
Secretary determines to be necessary for purposes of
providing temporary relief under paragraph (1).
(f) Determinations Regarding Effective Service.--In
carrying out subsection (a) and sections 338A(d) and 338B(d),
the Secretary shall carry out activities to determine--
(1) the characteristics of physicians, dentists,
and other health professionals who are more likely to
remain in practice in health professional shortage
areas after the completion of the period of service in
the Corps;
(2) the characteristics of health manpower shortage
areas \1\, and of entities seeking assignments of Corps
members, that are more likely to retain Corps members
after the members have completed the period of service
in the Corps; and
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``health professional shortage
areas''. See section 401 of Public Law 101-597 (104 Stat. 3035).
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(3) the appropriate conditions for the assignment
and utilization in health manpower shortage areas \1\
of certified nurse practitioners, certified nurse
midwives, and physician assistants.
annual reports
Sec. 336A. [254i] The Secretary shall submit an annual
report to Congress, and shall include in such report with
respect to the previous calendar year--
(1) the number, identity, and priority of all
health professional shortage areas designated in such
year and the number of health professional shortage
areas which the Secretary estimates will be designated
in the subsequent year;
(2) the number of applications filed under section
333 in such year for assignment of Corps members and
the action taken on each such application;
(3) the number and types of Corps members assigned
in such year to health professional shortage areas, the
number and types of additional Corps members which the
Secretary estimates will be assigned to such areas in
the subsequent year, and the need for additional
members for the Corps;
(4) the recruitment efforts engaged in for the
Corps in such year and the number of qualified
individuals who applied for service in the Corps in
such year;
(5) the number of patients seen and the number of
patient visits recorded during such year with respect
to each health professional shortage area to which a
Corps member was assigned during such year;
(6) the number of Corps members who elected, and
the number of Corps members who did not elect, to
continue to provide health services in health
professional shortage areas after termination of their
service in the Corps and the reasons (as reported to
the Secretary) of members who did not elect for not
making such election;
(7) the results of evaluations and determinations
made under section 333(a)(1)(D) during such year; and
(8) the amount charged during such year for health
services provided by Corps members, the amount which
was collected in such year by entities in accordance
with section 334, and the amount which was paid to the
Secretary in such year under such agreements \1\.
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\1\ There is no antecedent reference to ``agreements''. Formerly,
paragraph (8) contained the clause ``, the amount which was collected
in such year by entities in accordance with agreements under section
334,''. Section 307(b) of Public Law 107-251 (116 Stat. 1649) struck
``agreements under'' in that clause.
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national advisory council
Sec. 337. [254j] (a) There is established a council to be
known as the National Advisory Council on the National Health
Service Corps (hereinafter in this section referred to as the
``Council''). The Council shall be composed of fifteen members
appointed by the Secretary. The Council shall consult with,
advise, and make recommendations to, the Secretary with respect
to his responsibilities in carrying out this subpart (other
than section 338G), and shall review and comment upon
regulations promulgated by the Secretary under this subpart.
(b)(1) Members of the Council shall be appointed for a term
of three years, except that any member appointed to fill a
vacancy occurring prior to the expiration of the term for which
the member's predecessor was appointed shall be appointed for
the remainder of such term. No member shall be removed, except
for cause.
(2) Members of the Council (other than members who are
officers or employees of the United States), while attending
meetings or conferences thereof or otherwise serving on the
business of the Council, shall be entitled to receive for each
day (including traveltime) in which they are so serving
compensation at a rate fixed by the Secretary (but not to
exceed the daily equivalent of the annual rate of basic pay in
effect for grade GS-18 of the General Schedule); and while so
serving away from their homes or regular places of business all
members may be allowed travel expenses, including per diem in
lieu of subsistence, as authorized by section 5703 of title 5
of the United States Code for persons in the Government service
employed intermittently.
(c) Section 14 of the Federal Advisory Committee Act shall
not apply with respect to the Council.
authorization of appropriation
Sec. 338. [254k] (a) For the purpose of carrying out this
subpart, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2008 through
2012.
(b) An appropriation under an authorization under
subsection (a) for any fiscal year may be made at any time
before that fiscal year and may be included in an Act making an
appropriation under an authorization under subsection (a) for
another fiscal year; but no funds may be made available from
any appropriation under such authorization for obligation under
sections 331 through 335, section 336A, and section 337 before
the fiscal year for which such appropriation is authorized.
Subpart III--Scholarship Program and Loan Repayment Program
national health service corps scholarship program
Sec. 338A. [254l] (a) The Secretary shall establish the
National Health Service Corps Scholarship Program to assure,
with respect to the provision of primary health services
pursuant to section 331(a)(2)--
(1) an adequate supply of physicians, dentists,
behavioral and mental health professionals, certified
nurse midwives, certified nurse practitioners, and
physician assistants; and
(2) if needed by the Corps, an adequate supply of
other health professionals.
(b) To be eligible to participate in the Scholarship
Program, an individual must--
(1) be accepted for enrollment, or be enrolled, as
a full-time student (A) in an accredited (as determined
by the Secretary) educational institution in a State
and (B) in a course of study or program, offered by
such institution and approved by the Secretary, leading
to a degree in medicine, osteopathic medicine,
dentistry, or other health profession, or an
appropriate degree from a graduate program of
behavioral and mental health;
(2) be eligible for, or hold, an appointment as a
commissioned officer in the Regular or Reserve Corps of
the Service or be eligible for selection for civilian
service in the Corps;
(3) submit an application to participate in the
Scholarship Program; and
(4) sign and submit to the Secretary, at the time
of submittal of such application, a written contract
(described in subsection (f)) to accept payment of a
scholarship and to serve (in accordance with this
subpart) for the applicable period of obligated service
in a health professional shortage area.
(c)(1) In disseminating application forms and contract
forms to individuals desiring to participate in the Scholarship
Program, the Secretary shall include with such forms--
(A) a fair summary of the rights and liabilities of
an individual whose application is approved (and whose
contract is accepted) by the Secretary, including in
the summary a clear explanation of the damages to which
the United States is entitled under section 338E in the
case of the individual's breach of the contract; and
(B) information respecting meeting a service
obligation through private practice under an agreement
under section 338D and such other information as may be
necessary for the individual to understand the
individual's prospective participation in the
Scholarship Program and service in the Corps, including
a statement of all factors considered in approving
applications for participation in the Program and in
making assignments for participants in the Program.
(2) The application form, contract form, and all other
information furnished by the Secretary under this subpart shall
be written in a manner calculated to be understood by the
average individual applying to participate in the Scholarship
Program. The Secretary shall make such application forms,
contract forms, and other information available to individuals
desiring to participate in the Scholarship Program on a date
sufficiently early to insure that such individuals have
adequate time to carefully review and evaluate such forms and
information.
(3)(A) The Secretary shall distribute to health professions
schools materials providing information on the Scholarship
Program and shall encourage the schools to disseminate the
materials to the students of the schools.
(B)(i) In the case of any health professional whose period
of obligated service under the Scholarship Program is nearing
completion, the Secretary shall encourage the individual to
remain in a health professional shortage area and to continue
providing primary health services.
(ii) During the period in which a health professional is
planning and making the transition to private practice from
obligated service under the Scholarship Program, the Secretary
may provide assistance to the professional regarding such
transition if the professional is remaining in a health
professional shortage area and is continuing to provide primary
health services.
(C) In the case of entities to which participants in the
Scholarship Program are assigned under section 333, the
Secretary shall encourage the entities to provide options with
respect to assisting the participants in remaining in the
health professional shortage areas involved, and in continuing
to provide primary health services, after the period of
obligated service under the Scholarship Program is completed.
The options with respect to which the Secretary provides such
encouragement may include options regarding the sharing of a
single employment position in the health professions by 2 or
more health professionals, and options regarding the
recruitment of couples where both of the individuals are health
professionals.
(d)(1) Subject to section 333A, in providing contracts
under the Scholarship Program--
(A) the Secretary shall consider the extent of the
demonstrated interest of the applicants for the
contracts in providing primary health services;
(B) the Secretary, in considering applications from
individuals accepted for enrollment or enrolled in
dental school, shall consider applications from all
individuals accepted for enrollment or enrolled in any
accredited dental school in a State; and
(C) may consider such other factors regarding the
applicants as the Secretary determines to be relevant
to selecting qualified individuals to participate in
such Program.
(2) In providing contracts under the Scholarship Program,
the Secretary shall give priority--
(A) first, to any application for such a contract
submitted by an individual who has previously received
a scholarship under this section or under section 758;
(B) second, to any application for such a contract
submitted by an individual who has characteristics that
increase the probability that the individual will
continue to serve in a health professional shortage
area after the period of obligated service pursuant to
subsection (f) is completed; and
(C) third, subject to subparagraph (B), to any
application for such a contract submitted by an
individual who is from a disadvantaged background.
(e)(1) An individual becomes a participant in the
Scholarship Program only upon the Secretary's approval of the
individual's application submitted under subsection (b)(3) and
the Secretary's acceptance of the contract submitted by the
individual under subsection (b)(4).
(2) The Secretary shall provide written notice to an
individual promptly upon the Secretary's approving, under
paragraph (1), of the individual's participation in the
Scholarship Program.
(f) The written contract (referred to in this subpart)
between the Secretary and an individual shall contain--
(1) an agreement that--
(A) subject to paragraph (2), the Secretary
agrees (i) to provide the individual with a
scholarship (described in subsection (g)) in
each such school year or years for a period of
years (not to exceed four school years)
determined by the individual, during which
period the individual is pursuing a course of
study described in subsection (b)(1)(B), and
(ii) to accept (subject to the availability of
appropriated funds for carrying out sections
331 through 335 and section 337) the individual
into the Corps (or for equivalent service as
otherwise provided in this subpart); and
(B) subject to paragraph (2), the
individual agrees--
(i) to accept provision of such a
scholarship to the individual;
(ii) to maintain enrollment in a
course of study described in subsection
(b)(1)(B) until the individual
completes the course of study;
(iii) while enrolled in such course
of study, to maintain an acceptable
level of academic standing (as
determined under regulations of the
Secretary by the educational
institution offering such course of
study);
(iv) if pursuing a degree from a
school of medicine or osteopathic
medicine, to complete a residency in a
specialty that the Secretary determines
is consistent with the needs of the
Corps; and
(v) to serve for a time period
(hereinafter in the subpart referred to
as the ``period of obligated service'')
equal to--
(I) one year for each
school year for which the
individual was provided a
scholarship under the
Scholarship Program, or
(II) two years,
whichever is greater, as a provider of
primary health services in a health
professional shortage area (designated
under section 332) to which he is
assigned by the Secretary as a member
of the Corps, or as otherwise provided
in this subpart;
(2) a provision that any financial obligation of
the United States arising out of a contract entered
into under this subpart and any obligation of the
individual which is conditioned thereon, is contingent
upon funds being appropriated for scholarships under
this subpart and to carry out the purposes of sections
331 through 335 and sections 337 and 338;
(3) a statement of the damages to which the United
States is entitled, under section 338E for the
individual's breach of the contract; and
(4) such other statements of the rights and
liabilities of the Secretary and of the individual, not
inconsistent with the provisions of this subpart.
(g)(1) A scholarship provided to a student for a school
year under a written contract under the Scholarship Program
shall consist of--
(A) payment to, or (in accordance with paragraph
(2)) on behalf of, the student of the amount (except as
provided in section 711) of--
(i) the tuition of the student in such
school year; and
(ii) all other reasonable educational
expenses, including fees, books, and laboratory
expenses, incurred by the student in such
school year; and
(B) payment to the student of a stipend of $400 per
month (adjusted in accordance with paragraph (3)) for
each of the 12 consecutive months beginning with the
first month of such school year.
(2) The Secretary may contract with an educational
institution, in which a participant in the Scholarship Program
is enrolled, for the payment to the educational institution of
the amounts of tuition and other reasonable educational
expenses described in paragraph (1)(A). Payment to such an
educational institution may be made without regard to section
3648 of the Revised Statutes (31 U.S.C. 529).
(3) The amount of the monthly stipend, specified in
paragraph (1)(B) and as previously adjusted (if at all) in
accordance with this paragraph, shall be increased by the
Secretary for each school year ending in a fiscal year
beginning after September 30, 1978, by an amount (rounded to
the next highest multiple of $1) equal to the amount of such
stipend multiplied by the overall percentage (under section
5303 of title 5, United States Code) of the adjustment (if such
adjustment is an increase) in the rates of pay under the
General Schedule made effective in the fiscal year in which
such school year ends.
(h) Notwithstanding any other provision of law, individuals
who have entered into written contracts with the Secretary
under this section, while undergoing academic training, shall
not be counted against any employment ceiling affecting the
Department.
SEC. 338B. [254L-1] NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT
PROGRAM.
(a) Establishment.--The Secretary shall establish a program
to be known as the National Health Service Corps Loan Repayment
Program to assure, with respect to the provision of primary
health services pursuant to section 331(a)(2)--
(1) an adequate supply of physicians, dentists,
behavioral and mental health professionals, certified
nurse midwives, certified nurse practitioners, and
physician assistants; and
(2) if needed by the Corps, an adequate supply of
other health professionals.
(b) Eligibility.--To be eligible to participate in the Loan
Repayment Program, an individual must--
(1)(A) have a degree in medicine, osteopathic
medicine, dentistry, or another health profession, or
an appropriate degree from a graduate program of
behavioral and mental health, or be certified as a
nurse midwife, nurse practitioner, or physician
assistant;
(B) be enrolled in an approved graduate training
program in medicine, osteopathic medicine, dentistry,
behavioral and mental health, or other health
profession; or
(C) be enrolled as a full-time student--
(i) in an accredited (as determined by the
Secretary) educational institution in a State;
and
(ii) in the final year of a course of a
study or program, offered by such institution
and approved by the Secretary, leading to a
degree in medicine, osteopathic medicine,
dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a
commissioned officer in the Regular or Reserve Corps of
the Service or be eligible for selection for civilian
service in the Corps; and
(3) submit to the Secretary an application for a
contract described in subsection (f) (relating to the
payment by the Secretary of the educational loans of
the individual in consideration of the individual
serving for a period of obligated service).
(c) Application, Contract, and Information Requirements.--
(1) Summary and information.--In disseminating
application forms and contract forms to individuals
desiring to participate in the Loan Repayment Program,
the Secretary shall include with such forms--
(A) a fair summary of the rights and
liabilities of an individual whose application
is approved (and whose contract is accepted) by
the Secretary, including in the summary a clear
explanation of the damages to which the United
States is entitled under section 338E in the
case of the individual's breach of the
contract; and
(B) information respecting meeting a
service obligation through private practice
under an agreement under section 338D and such
other information as may be necessary for the
individual to understand the individual's
prospective participation in the Loan Repayment
Program and service in the Corps.
(2) Understandability.--The application form,
contract form, and all other information furnished by
the Secretary under this subpart shall be written in a
manner calculated to be understood by the average
individual applying to participate in the Loan
Repayment Program.
(3) Availability.--The Secretary shall make such
application forms, contract forms, and other
information available to individuals desiring to
participate in the Loan Repayment Program on a date
sufficiently early to ensure that such individuals have
adequate time to carefully review and evaluate such
forms and information.
(4) Recruitment and retention.--
(A) The Secretary shall distribute to
health professions schools materials providing
information on the Loan Repayment Program and
shall encourage the schools to disseminate the
materials to the students of the schools.
(B)(i) In the case of any health
professional whose period of obligated service
under the Loan Repayment Program is nearing
completion, the Secretary shall encourage the
individual to remain in a health professional
shortage area and to continue providing primary
health services.
(ii) During the period in which a health
professional is planning and making the
transition to private practice from obligated
service under the Loan Repayment Program, the
Secretary may provide assistance to the
professional regarding such transition if the
professional is remaining in a health
professional shortage area and is
continuing to provide primary health services.
(C) In the case of entities to which
participants in the Loan Repayment Program are
assigned under section 333, the Secretary shall
encourage the entities to provide options with
respect to assisting the participants in
remaining in the health professional shortage
areas involved, and in continuing to provide
primary health services, after the period of
obligated service under the Loan Repayment
Program is completed. The options with respect
to which the Secretary provides such
encouragement may include options regarding the
sharing of a single employment position in the
health professions by 2 or more health
professionals, and options regarding the
recruitment of couples where both of the
individuals are health professionals.
(d)(1) Subject to section 333A, in providing contracts
under the Loan Repayment Program--
(A) the Secretary shall consider the extent of the
demonstrated interest of the applicants for the
contracts in providing primary health services; and
(B) may consider such other factors regarding the
applicants as the Secretary determines to be relevant
to selecting qualified individuals to participate in
such Program.
(2) In providing contracts under the Loan Repayment
Program, the Secretary shall give priority--
(A) to any application for such a contract
submitted by an individual whose training is in a
health profession or specialty determined by the
Secretary to be needed by the Corps;
(B) to any application for such a contract
submitted by an individual who has (and whose spouse,
if any, has) characteristics that increase the
probability that the individual will continue to serve
in a health professional shortage area after the period
of obligated service pursuant to subsection (f) is
completed; and
(C) subject to subparagraph (B), to any application
for such a contract submitted by an individual who is
from a disadvantaged background.
(e) Approval Required for Participation.--An individual
becomes a participant in the Loan Repayment Program only upon
the Secretary and the individual entering into a written
contract described in subsection (f).
(f) Contents of Contracts.--The written contract (referred
to in this subpart) between the Secretary and an individual
shall contain--
(1) an agreement that--
(A) subject to paragraph (3), the Secretary
agrees--
(i) to pay on behalf of the
individual loans in accordance with
subsection (g); and
(ii) to accept (subject to the
availability of appropriated funds for
carrying out sections 331 through 335
and section 337) the individual into
the Corps (or for equivalent service as
otherwise provided in this subpart);
and
(B) subject to paragraph (3), the
individual agrees--
(i) to accept loan payments on
behalf of the individual;
(ii) in the case of an individual
described in subsection (b)(1)(C), to
maintain enrollment in a course of
study or training described in such
subsection until the individual
completes the course of study or
training;
(iii) in the case of an individual
described in subsection (b)(1)(C),
while enrolled in such course of study
or training, to maintain an acceptable
level of academic standing (as
determined under regulations of the
Secretary by the educational
institution offering such course of
study or training); and
(iv) to serve for a time period
(hereinafter in this subpart referred
to as the ``period of obligated
service'') equal to 2 years or such
longer period as the individual may
agree to, as a provider of primary
health services in a health
professional shortage area (designated
under section 332) to which such
individual is assigned by the Secretary
as a member of the Corps or released
under section 338D;
(2) a provision permitting the Secretary to extend
for such longer additional periods, as the individual
may agree to, the period of obligated service agreed to
by the individual under paragraph (1)(B)(iv), including
extensions resulting in an aggregate period of
obligated service in excess of 4 years;
(3) a provision that any financial obligation of
the United States arising out of a contract entered
into under this subpart and any obligation of the
individual that is conditioned thereon, is contingent
on funds being appropriated for loan repayments under
this subpart and to carry out the purposes of sections
331 through 335 and sections 337 and 338;
(4) a statement of the damages to which the United
States is entitled, under section 338E for the
individual's breach of the contract; and
(5) such other statements of the rights and
liabilities of the Secretary and of the individual, not
inconsistent with this subpart.
(g) Payments.--
(1) In general.--A loan repayment provided for an
individual under a written contract under the Loan
Repayment Program shall consist of payment, in
accordance with paragraph (2), on behalf of the
individual of the principal, interest, and related
expenses on government and commercial loans received by
the individual regarding the undergraduate or graduate
education of the individual (or both), which loans were
made for--
(A) tuition expenses;
(B) all other reasonable educational
expenses, including fees, books, and laboratory
expenses, incurred by the individual; or
(C) reasonable living expenses as
determined by the Secretary.
(2) Payments for years served.--
(A) In general.--For each year of obligated
service that an individual contracts to serve
under subsection (f) the Secretary may pay up
to $50,000, plus, beginning with fiscal year
2012, an amount determined by the Secretary on
an annual basis to reflect inflation, on behalf
of the individual for loans described in
paragraph (1). In making a determination of the
amount to pay for a year of such service by an
individual, the Secretary shall consider the
extent to which each such determination--
(i) affects the ability of the
Secretary to maximize the number of
contracts that can be provided under
the Loan Repayment Program from the
amounts appropriated for such
contracts;
(ii) provides an incentive to serve
in health professional shortage areas
with the greatest such shortages; and
(iii) provides an incentive with
respect to the health professional
involved remaining in a health
professional shortage area, and
continuing to provide primary health
services, after the completion of the
period of obligated service under the
Loan Repayment Program.
(B) Repayment schedule.--Any arrangement
made by the Secretary for the making of loan
repayments in accordance with this subsection
shall provide that any repayments for a year of
obligated service shall be made no later than
the end of the fiscal year in which the
individual completes such year of service.
(3) Tax liability.--For the purpose of providing
reimbursements for tax liability resulting from
payments under paragraph (2) on behalf of an
individual--
(A) the Secretary shall, in addition to
such payments, make payments to the individual
in an amount equal to 39 percent of the total
amount of loan repayments made for the taxable
year involved; and
(B) may make such additional payments as
the Secretary determines to be appropriate with
respect to such purpose.
(4) Payment schedule.--The Secretary may enter into
an agreement with the holder of any loan for which
payments are made under the Loan Repayment Program to
establish a schedule for the making of such payments.
(h) Employment Ceiling.--Notwithstanding any other
provision of law, individuals who have entered into written
contracts with the Secretary under this section, while
undergoing academic or other training, shall not be counted
against any employment ceiling affecting the Department.
obligated service
Sec. 338C. [254m] (a) Service in Full-time Clinical
Practice.--Except as provided in section 338D, each individual
who has entered into a written contract with the Secretary
under section 338A or 338B shall provide service in the full-
time clinical practice of such individual's profession as a
member of the Corps for the period of obligated service
provided in such contract. The Secretary may treat teaching as
clinical practice for up to 20 percent of such period of
obligated service. Notwithstanding the preceding sentence, with
respect to a member of the Corps participating in the teaching
health centers graduate medical education program under section
340H, for the purpose of calculating time spent in full-time
clinical practice under this section, up to 50 percent of time
spent teaching by such member may be counted toward his or her
service obligation.
(b)(1) If an individual is required under subsection (a) to
provide service as specified in section 338A(f)(1)(B)(v) or
338B(f)(1)(B)(iv) (hereinafter in this subsection referred to
as ``obligated service''), the Secretary shall, not later than
ninety days before the date described in paragraph (5),
determine if the individual shall provide such service--
(A) as a member of the Corps who is a commissioned
officer in the Regular or Reserve Corps of the Service
or who is a civilian employee of the United States, or
(B) as a member of the Corps who is not such an
officer or employee,
and shall notify such individual of such determination.
(2) If the Secretary determines that an individual shall
provide obligated service as a member of the Corps who is a
commissioned officer in the Service or a civilian employee of
the United States, the Secretary shall, not later than sixty
days before the date described in paragraph (5), provide such
individual with sufficient information regarding the advantages
and disadvantages of service as such a commissioned officer or
civilian employee to enable the individual to make a decision
on an informed basis. To be eligible to provide obligated
service as a commissioned officer in the Service, an individual
shall notify the Secretary, not later than thirty days before
the date described in paragraph (5), of the individual's desire
to provide such service as such an officer. If an individual
qualifies for an appointment as such an officer, the Secretary
shall, as soon as possible after the date described in
paragraph (5), appoint the individual as a commissioned officer
of the Regular or Reserve Corps of the Service and shall
designate the individual as a member of the Corps.
(3) If an individual provided notice by the Secretary under
paragraph (2) does not qualify for appointment as a
commissioned officer in the Service, the Secretary shall, as
soon as possible after the date described in paragraph (5),
appoint such individual as a civilian employee of the United
States and designate the individual as a member of the Corps.
(4) If the Secretary determines that an individual shall
provide obligated service as a member of the Corps who is not
an employee of the United States, the Secretary shall, as soon
as possible after the date described in paragraph (5),
designate such individual as a member of the Corps to provide
such service.
(5)(A) In the case of the Scholarship Program, the date
referred to in paragraphs (1) through (4) shall be the date on
which the individual completes the training required for the
degree for which the individual receives the scholarship,
except that--
(i) for an individual receiving such a degree after
September 30, 2000, from a school of medicine or
osteopathic medicine, such date shall be the date the
individual completes a residency in a specialty that
the Secretary determines is consistent with the needs
of the Corps; and
(ii) at the request of an individual, the Secretary
may, consistent with the needs of the Corps, defer such
date until the end of a period of time required for the
individual to complete advanced training (including an
internship or residency).
(B) No period of internship, residency, or other advanced
clinical training shall be counted toward satisfying a period
of obligated service under this subpart.
(C) In the case of the Loan Repayment Program, if an
individual is required to provide obligated service under such
Program, the date referred to in paragraphs (1) through (4)--
(i) shall be the date determined under subparagraph
(A) in the case of an individual who is enrolled in the
final year of a course of study;
(ii) shall, in the case of an individual who is
enrolled in an approved graduate training program in
medicine, osteopathic medicine, dentistry, or other
health profession, be the date the individual completes
such training program; and
(iii) shall, in the case of an individual who has a
degree in medicine, osteopathic medicine, dentistry, or
other health profession and who has completed graduate
training, be the date the individual enters into an
agreement with the Secretary under section 338B.
(c) An individual shall be considered to have begun serving
a period of obligated service--
(1) on the date such individual is appointed as an
officer in a Regular or Reserve Corps of the Service or
is designated as a member of the Corps under subsection
(b)(3) or (b)(4), or
(2) in the case of an individual who has entered
into an agreement with the Secretary under section
338D, on the date specified in such agreement,
whichever is earlier.
(d) The Secretary shall assign individuals performing
obligated service in accordance with a written contract under
the Scholarship Program to health professional shortage areas
in accordance with sections 331 through 335 and sections 337
and 338. If the Secretary determines that there is no need in a
health professional shortage area (designated under section
332) for a member of the profession in which an individual is
obligated to provide service under a written contract and if
such individual is an officer in the Service or a civilian
employee of the United States, the Secretary may detail such
individual to serve his period of obligated service as a full-
time member of such profession in such unit of the Department
as the Secretary may determine.
private practice
Sec. 338D. [254n] (a) The Secretary shall, to the extent
permitted by, and consistent with, the requirements of
applicable State law, release an individual from all or part of
his service obligation under section 338C(a) or under section
225 (as in effect on September 30, 1977) if the individual
applies for such a release under this section and enters into a
written agreement with the Secretary under which the individual
agrees to engage for a period equal to the remaining period of
his service obligation in the full-time private clinical
practice (including service as a salaried employee in an entity
directly providing health services) of his health profession--
(1) in the case of an individual who received a
scholarship under the Scholarship Program or a loan
repayment under the Loan Repayment Program and who is
performing obligated service as a member of the Corps
in a health professional shortage area on the date of
his application for such a release, in the health
professional shortage area in which such individual is
serving on such date or in the case of an individual
for whom a loan payment was made under the Loan
Repayment Program and who is performing obligated
service as a member of the Corps in a health
professional shortage area on the date of the
application of the individual for such a release, in
the health professional shortage area selected by the
Secretary; or
(2) in the case of any other individual, in a
health professional shortage area (designated under
section 332) selected by the Secretary.
(b)(1) The written agreement described in subsection (a)
shall--
(A) provide that, during the period of private
practice by an individual pursuant to the agreement,
the individual shall comply with the requirements of
section 334 that apply to entities; and
(B) contain such additional provisions as the
Secretary may require to carry out the objectives of
this section.
(2) The Secretary shall take such action as may be
appropriate to ensure that the conditions of the written
agreement prescribed by this subsection are adhered to.
(c) If an individual breaches the contract entered into
under section 338A or 338B by failing (for any reason) to begin
his service obligation in accordance with an agreement entered
into under subsection (a) or to complete such service
obligation, the Secretary may permit such individual to perform
such service obligation as a member of the Corps.
(d) The Secretary may pay an individual who has entered
into an agreement with the Secretary under subsection (a) an
amount to cover all or part of the individual's expenses
reasonably incurred in transporting himself, his family, and
his possessions to the location of his private clinical
practice.
(e) Upon the expiration of the written agreement under
subsection (a), the Secretary may (notwithstanding any other
provision of law) sell to the individual who has entered into
an agreement with the Secretary under subsection (a), equipment
and other property of the United States utilized by such
individual in providing health services. Sales made under this
subsection shall be made at the fair market value (as
determined by the Secretary) of the equipment or such other
property, except that the Secretary may make such sales for a
lesser value to the individual if he determines that the
individual is financially unable to pay the full market value.
(f) The Secretary may, out of appropriations authorized
under section 338, pay to individuals participating in private
practice under this section the cost of such individual's
malpractice insurance and the lesser of--
(1)(A) $10,000 in the first year of obligated
service;
(B) $7,500 in the second year of obligated service;
(C) $5,000 in the third year of obligated service;
and
(D) $2,500 in the fourth year of obligated service;
or
(2) an amount determined by subtracting such
individual's net income before taxes from the income
the individual would have received as a member of the
Corps for each such year of obligated service.
(g) The Secretary shall, upon request, provide to each
individual released from service obligation under this section
technical assistance to assist such individual in fulfilling
his or her agreement under this section.
breach of scholarship contract or loan repayment contract
Sec. 338E. [254o] (a)(1) An individual who has entered into
a written contract with the Secretary under section 338A and
who--
(A) fails to maintain an acceptable level of
academic standing in the educational institution in
which he is enrolled (such level determined by the
educational institution under regulations of the
Secretary);
(B) is dismissed from such educational institution
for disciplinary reasons; or
(C) voluntarily terminates the training in such an
educational institution for which he is provided a
scholarship under such contract, before the completion
of such training,
in lieu of any service obligation arising under such contract,
shall be liable to the United States for the amount which has
been paid to him, or on his behalf, under the contract.
(2) An individual who has entered into a written contract
with the Secretary under section 338B and who--
(A) in the case of an individual who is enrolled in
the final year of a course of study, fails to maintain
an acceptable level of academic standing in the
educational institution in which such individual is
enrolled (such level determined by the educational
institution under regulations of the Secretary) or
voluntarily terminates such enrollment or is dismissed
from such educational institution before completion of
such course of study; or
(B) in the case of an individual who is enrolled in
a graduate training program, fails to complete such
training program and does not receive a waiver from the
Secretary under section 338B(b)(1)(B)(ii),
in lieu of any service obligation arising under such contract
shall be liable to the United States for the amount that has
been paid on behalf of the individual under the contract.
(b)(1)(A) Except as provided in paragraph (2), if (for any
reason not specified in subsection (a) or section 338G(d)) an
individual breaches his written contract by failing to begin
such individual's service obligation under section 338A in
accordance with section 338C or 338D, to complete such service
obligation, or to complete a required residency as specified in
section 338A(f)(1)(B)(iv), the United States shall be entitled
to recover from the individual an amount determined in
accordance with the formula
A=3q(t-s/t)
in which ``A'' is the amount the United States is entitled to
recover, ``q'' is the sum of the amounts paid under this
subpart to or on behalf of the individual and the interest on
such amounts which would be payable if at the time the amounts
were paid they were loans bearing interest at the maximum legal
prevailing rate, as determined by the Treasurer of the United
States; ``t'' is the total number of months in the individual's
period of obligated service; and ``s'' is the number of months
of such period served by him in accordance with section 338C or
a written agreement under section 338D.
(B)(i) Any amount of damages that the United States is
entitled to recover under this subsection or under subsection
(c) shall, within the 1-year period beginning on the date of
the breach of the written contract (or such longer period
beginning on such date as specified by the Secretary), be paid
to the United States. Amounts not paid within such period shall
be subject to collection through deductions in Medicare
payments pursuant to section 1892 of the Social Security Act.
(ii) If damages described in clause (i) are delinquent for
3 months, the Secretary shall, for the purpose of recovering
such damages--
(I) utilize collection agencies contracted with by
the Administrator of the General Services
Administration; or
(II) enter into contracts for the recovery of such
damages with collection agencies selected by the
Secretary.
(iii) Each contract for recovering damages pursuant to this
subsection shall provide that the contractor will, not less
than once each 6 months, submit to the Secretary a status
report on the success of the contractor in collecting such
damages. Section 3718 of title 31, United States Code, shall
apply to any such contract to the extent not inconsistent with
this subsection.
(iv) To the extent not otherwise prohibited by law, the
Secretary shall disclose to all appropriate credit reporting
agencies information relating to damages of more than $100 that
are entitled to be recovered by the United States under this
subsection and that are delinquent by more than 60 days or such
longer period as is determined by the Secretary.
(2) If an individual is released under section 753 from a
service obligation under section 225 (as in effect on September
30, 1977) and if the individual does not meet the service
obligation incurred under section 753, subsection (f) of such
section 225 shall apply to such individual in lieu of paragraph
(1) of this subsection.
(3) The Secretary may terminate a contract with an
individual under section 338A if, not later than 30 days before
the end of the school year to which the contract pertains, the
individual--
(A) submits a written request for such termination;
and
(B) repays all amounts paid to, or on behalf of,
the individual under section 338A(g).
(c)(1) If (for any reason not specified in subsection (a)
or section 338G(d)) an individual breaches the written contract
of the individual under section 338B by failing either to begin
such individual's service obligation in accordance with section
338C or 338D or to complete such service obligation, the United
States shall be entitled to recover from the individual an
amount equal to the sum of--
(A) the total of the amounts paid by the United
States under section 338B(g) on behalf of the
individual for any period of obligated service not
served;
(B) an amount equal to the product of the number of
months of obligated service that were not completed by
the individual, multiplied by $7,500; and
(C) the interest on the amounts described in
subparagraphs (A) and (B), at the maximum legal
prevailing rate, as determined by the Treasurer of the
United States, from the date of the breach;
except that the amount the United States is entitled to recover
under this paragraph shall not be less than $31,000.
(2) The Secretary may terminate a contract with an
individual under section 338B if, not later than 45 days before
the end of the fiscal year in which the contract was entered
into, the individual--
(A) submits a written request for such termination;
and
(B) repays all amounts paid on behalf of the
individual under section 338B(g).
(3) Damages that the United States is entitled to recover
shall be paid in accordance with subsection (b)(1)(B).
(d)(1) Any obligation of an individual under the
Scholarship Program (or a contract thereunder) or the Loan
Repayment Program (or a contract thereunder) for service or
payment of damages shall be canceled upon the death of the
individual.
(2) The Secretary shall by regulation provide for the
partial or total waiver or suspension of any obligation of
service or payment by an individual under the Scholarship
Program (or a contract thereunder) or the Loan Repayment
Program (or a contract thereunder) whenever compliance by the
individual is impossible or would involve extreme hardship to
the individual and if enforcement of such obligation with
respect to any individual would be unconscionable.
(3)(A) Any obligation of an individual under the
Scholarship Program (or a contract thereunder) or the Loan
Repayment Program (or a contract thereunder) for payment of
damages may be released by a discharge in bankruptcy under
title 11 of the United States Code only if such discharge is
granted after the expiration of the 7-year period beginning on
the first date that payment of such damages is required, and
only if the bankruptcy court finds that nondischarge of the
obligation would be unconscionable.
(B)(i) Subparagraph (A) shall apply to any financial
obligation of an individual under the provision of law
specified in clause (ii) to the same extent and in the same
manner as such subparagraph applies to any obligation of an
individual under the Scholarship or Loan Repayment Program (or
contract thereunder) for payment of damages.
(ii) The provision of law referred to in clause (i) is
subsection (f) of section 225 of this Act, as in effect prior
to the repeal of such section by section 408(b)(1) of Public
Law 94-484.
(e) Notwithstanding any other provision of Federal or State
law, there shall be no limitation on the period within which
suit may be filed, a judgment may be enforced, or an action
relating to an offset or garnishment, or other action, may be
initiated or taken by the Secretary, the Attorney General, or
the head of another Federal agency, as the case may be, for the
repayment of the amount due from an individual under this
section.
(f) The amendment made by section 313(a)(4) of the Health
Care Safety Net Amendments of 2002 (Public Law 107-251) shall
apply to any obligation for which a discharge in bankruptcy has
not been granted before the date that is 31 days after the date
of enactment of such Act.
SEC. 338F. [254O-1] FUND REGARDING USE OF AMOUNTS RECOVERED FOR
CONTRACT BREACH TO REPLACE SERVICES LOST AS RESULT
OF BREACH.
(a) Establishment of Fund.--There is established in the
Treasury of the United States a fund to be known as the
National Health Service Corps Member Replacement Fund
(hereafter in this section referred to as the ``Fund''). The
Fund shall consist of such amounts as may be appropriated under
subsection (b) to the Fund. Amounts appropriated for the Fund
shall remain available until expended.
(b) Authorization of Appropriations to Fund.--For each
fiscal year, there is authorized to be appropriated to the Fund
an amount equal to the sum of--
(1) the amount collected during the preceding
fiscal year by the Federal Government pursuant to the
liability of individuals under section 338E for the
breach of contracts entered into under section 338A or
338B;
(2) the amount by which grants under section 338I
have, for such preceding fiscal year, been reduced
under subsection (g)(2)(B) of such section; and
(3) the aggregate of the amount of interest
accruing during the preceding fiscal year on
obligations held in the Fund pursuant to subsection (d)
and the amount of proceeds from the sale or redemption
of such obligations during such fiscal year.
(c) Use of Fund.--
(1) Payments to certain health facilities.--Amounts
in the Fund and available pursuant to appropriations
Act may, subject to paragraph (2), be expended by the
Secretary to make payments to any entity--
(A) to which a Corps member has been
assigned under section 333; and
(B) that has a need for a health
professional to provide primary health services
as a result of the Corps member having breached
the contract entered into under section 338A or
338B by the individual.
(2) Purpose of payments.--An entity receiving
payments pursuant to paragraph (1) may expend the
payments to recruit and employ a health professional to
provide primary health services to patients of the
entity, or to enter into a contract with such a
professional to provide the services to the patients.
(d) Investment.--
(1) In general.--The Secretary of the Treasury
shall invest such amounts of the Fund as such Secretary
determines are not required to meet current withdrawals
from the Fund. Such investments may be made only in
interest-bearing obligations of the United States. For
such purpose, such obligations may be acquired on
original issue at the issue price, or by purchase of
outstanding obligations at the market price.
(2) Sale of obligations.--Any obligation acquired
by the Fund may be sold by the Secretary of the
Treasury at the market price.
special loans for former corps members to enter private practice
Sec. 338G. [254p] (a) The Secretary may, out of
appropriations authorized under section 338, make one loan to a
Corps member who has agreed in writing--
(1) to engage in the private full-time clinical
practice of the profession of the member in a health
professional shortage area (designated under section
332) for a period of not less than 2 years which--
(A) in the case of a Corps member who is
required to complete a period of obligated
service under this subpart, begins not later
than 1 year after the date on which such
individual completes such period of obligated
service; and
(B) in the case of an individual who is not
required to complete a period of obligated
service under this subpart, begins at such time
as the Secretary considers appropriate;
(2) to conduct such practice in accordance with
section 338D(b)(1); and
(3) to such additional conditions as the Secretary
may require to carry out this section.
Such a loan shall be used to assist such individual in meeting
the costs of beginning the practice of such individual's
profession in accordance with such agreement, including the
costs of acquiring equipment and renovating facilities for use
in providing health services, and of hiring nurses and other
personnel to assist in providing health services. Such loan may
not be used for the purchase or construction of any building.
(b)(1) The amount of a loan under subsection (a) to an
individual shall not exceed $25,000.
(2) The interest rate for any such loan shall not exceed an
annual rate of 5 percent.
(c) The Secretary may not make a loan under this section
unless an application therefor has been submitted to, and
approved by, the Secretary. The Secretary shall, by regulation,
set interest rates and repayment terms for loans under this
section.
(d) If the Secretary determines that an individual has
breached a written agreement entered into under subsection (a),
he shall, as soon as practicable after making such
determination notify the individual of such determination. If
within 60 days after the date of giving such notice, such
individual is not practicing his profession in accordance with
the agreement under such subsection and has not provided
assurances satisfactory to the Secretary that he will not
knowingly violate such agreement again, the United States shall
be entitled to recover from such individual--
(1) in the case of an individual who has received a
grant under this section (as in effect prior to October
1, 1984), an amount determined under section 338E(b),
except that in applying the formula contained in such
section ``q'' shall be the sum of the amount of the
grant made under subsection (a) to such individual and
the interest on such amount which would be payable if
at the time it was paid it was a loan bearing interest
at the maximum legal prevailing rate, ``t'' shall be
the number of months that such individual agreed to
practice his profession under agreement, and ``s''
shall be the number of months that such individual
practices his profession in accordance with such
agreement; and
(2) in the case of an individual who has received a
loan under this section, the full amount of the
principal and interest owed by such individual under
this section.
SEC. 338H. [254Q] AUTHORIZATION OF APPROPRIATIONS.
(a) Authorization of Appropriations.--For the purpose of
carrying out this section \1\, there is authorized to be
appropriated, out of any funds in the Treasury not otherwise
appropriated, the following:
---------------------------------------------------------------------------
\1\ The reference to ``this section'' in section 338H(a) probably
should be a reference to ``this subpart''.
---------------------------------------------------------------------------
(1) For fiscal year 2010, $320,461,632.
(2) For fiscal year 2011, $414,095,394.
(3) For fiscal year 2012, $535,087,442.
(4) For fiscal year 2013, $691,431,432.
(5) For fiscal year 2014, $893,456,433.
(6) For fiscal year 2015, $1,154,510,336.
(7) For fiscal year 2016, and each subsequent
fiscal year, the amount appropriated for the preceding
fiscal year adjusted by the product of--
(A) one plus the average percentage
increase in the costs of health professions
education during the prior fiscal year; and
(B) one plus the average percentage change
in the number of individuals residing in health
professions shortage areas designated under
section 333 during the prior fiscal year,
relative to the number of individuals residing
in such areas during the previous fiscal year.
(b) Scholarships for New Participants.--Of the amounts
appropriated under subsection (a) for a fiscal year, the
Secretary shall obligate not less than 10 percent for the
purpose of providing contracts for--
(1) scholarships under this subpart to individuals
who have not previously received such scholarships; or
(2) scholarships or loan repayments under the Loan
Repayment Program under section 338B to individuals
from disadvantaged backgrounds.
(c) Scholarships and Loan Repayments.--With respect to
certification as a nurse practitioner, nurse midwife, or
physician assistant, the Secretary shall, from amounts
appropriated under subsection (a) for a fiscal year, obligate
not less than a total of 10 percent for contracts for both
scholarships under the Scholarship Program under section 338A
and loan repayments under the Loan Repayment Program under
section 338B to individuals who are entering the first year of
a course of study or program described in section 338A(b)(1)(B)
that leads to such a certification or individuals who are
eligible for the loan repayment program as specified in section
338B(b) for a loan related to such certification.
SEC. 338I. [254Q-1] GRANTS TO STATES FOR LOAN REPAYMENT PROGRAMS.
(a) In General.--
(1) Authority for grants.--The Secretary, acting
through the Administrator of the Health Resources and
Services Administration, may make grants to States for
the purpose of assisting the States in operating
programs described in paragraph (2) in order to provide
for the increased availability of primary health care
services in health professional shortage areas. The
National Advisory Council established under section 337
shall advise the Administrator regarding the program
under this section.
(2) Loan repayment programs.--The programs referred
to in paragraph (1) are, subject to subsection (c),
programs of entering into contracts under which the
State involved agrees to pay all or part of the
principal, interest, and related expenses of the
educational loans of health professionals in
consideration of the professionals agreeing to provide
primary health services in health professional shortage
areas.
(3) Direct administration by state agency.--The
Secretary may not make a grant under paragraph (1)
unless the State involved agrees that the program
operated with the grant will be administered directly
by a State agency.
(b) Requirement of Matching Funds.--
(1) In general.--The Secretary may not make a grant
under subsection (a) unless the State agrees that, with
respect to the costs of making payments on behalf of
individuals under contracts made pursuant to paragraph
(2) of such subsection, the State will make available
(directly or through donations from public or private
entities) non-Federal contributions in cash toward such
costs in an amount equal to not less than $1 for each
$1 of Federal funds provided in the grant.
(2) Determination of amount of non-federal
contribution.--In determining the amount of non-Federal
contributions in cash that a State has provided
pursuant to paragraph (1), the Secretary may not
include any amounts provided to the State by the
Federal Government.
(c) Coordination With Federal Program.--
(1) Assignments for health professional shortage
areas under federal program.--The Secretary may not
make a grant under subsection (a) unless the State
involved agrees that, in carrying out the program
operated with the grant, the State will assign health
professionals participating in the program only to
public and nonprofit private entities located in and
providing health services in health professional
shortage areas.
(2) Remedies for breach of contracts.--The
Secretary may not make a grant under subsection (a)
unless the State involved agrees that the contracts
provided by the State pursuant to paragraph (2) of such
subsection will provide remedies for any breach of the
contracts by the health professionals involved.
(3) Limitation regarding contract inducements.--
(A) Except as provided in subparagraph (B),
the Secretary may not make a grant under
subsection (a) unless the State involved agrees
that the contracts provided by the State
pursuant to paragraph (2) of such subsection
will not be provided on terms that are more
favorable to health professionals than the most
favorable terms that the Secretary is
authorized to provide for contracts under the
Loan Repayment Program under section 338B,
including terms regarding--
(i) the annual amount of payments
provided on behalf of the professionals
regarding educational loans; and
(ii) the availability of remedies
for any breach of the contracts by the
health professionals involved.
(B) With respect to the limitation
established in subparagraph (A) regarding the
annual amount of payments that may be provided
to a health professional under a contract
provided by a State pursuant to subsection
(a)(2), such limitation shall not apply with
respect to a contract if--
(i) the excess of such annual
payments above the maximum amount
authorized in section 338B(g)(2)(A) for
annual payments regarding contracts is
paid solely from non-Federal
contributions under subsection (b); and
(ii) the contract provides that the
health professional involved will
satisfy the requirement of obligated
service under the contract solely
through the provision of primary health
services in a health professional
shortage area that is receiving
priority for purposes of section
333A(a)(1) and that is authorized to
receive assignments under section 333
of individuals who are participating in
the Scholarship Program under section
338A.
(d) Restrictions on Use of Funds.--The Secretary may not
make a grant under subsection (a) unless the State involved
agrees that the grant will not be expended--
(1) to conduct activities for which Federal funds
are expended--
(A) within the State to provide technical
or other nonfinancial assistance under
subsection (f) of section 330;
(B) under a memorandum of agreement entered
into with the State under subsection (h) of
such section; or
(C) under a grant under section 338J; or
(2) for any purpose other than making payments on
behalf of health professionals under contracts entered
into pursuant to subsection (a)(2).
(e) Reports.--The Secretary may not make a grant under
subsection (a) unless the State involved agrees--
(1) to submit to the Secretary such reports
regarding the States loan repayment program, as are
determined to be appropriate by the Secretary; and
(2) to submit such a report not later than January
10 of each fiscal year immediately following any fiscal
year for which the State has received such a grant.
(f) Requirement of Application.--The Secretary may not make
a grant under subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in
such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary
determines to be necessary to carry out such subsection.
(g) Noncompliance.--
(1) In general.--The Secretary may not make
payments under subsection (a) to a State for any fiscal
year subsequent to the first fiscal year of such
payments unless the Secretary determines that, for the
immediately preceding fiscal year, the State has
complied with each of the agreements made by the State
under this section.
(2) Reduction in grant relative to number of
breached contracts.--
(A) Before making a grant under subsection
(a) to a State for a fiscal year, the Secretary
shall determine the number of contracts
provided by the State under paragraph (2) of
such subsection with respect to which there has
been an initial breach by the health
professionals involved during the fiscal year
preceding the fiscal year for which the State
is applying to receive the grant.
(B) Subject to paragraph (3), in the case
of a State with 1 or more initial breaches for
purposes of subparagraph (A), the Secretary
shall reduce the amount of a grant under
subsection (a) to the State for the fiscal year
involved by an amount equal to the sum of the
expenditures of Federal funds made regarding
the contracts involved and an amount
representing interest on the amount of such
expenditures, determined with respect to each
contract on the basis of the maximum legal rate
prevailing for loans made during the time
amounts were paid under the contract, as
determined by the Treasurer of the United
States.
(3) Waiver regarding reduction in grant.--The
Secretary may waive the requirement established in
paragraph (2)(B) with respect to the initial breach of
a contract if the Secretary determines that such breach
by the health professional involved was attributable
solely to the professional having a serious illness.
(h) Definitions.--For purposes of this section, the term
``State'' means each of the 50 States, the District of
Columbia, the Commonwealth of Puerto Rico, the United States
Virgin Islands, Guam, American Samoa, Palau, the Marshall
Islands, and the Commonwealth of the Northern Mariana Islands.
(i) Authorization of Appropriations.--
(1) In general.--For the purpose of making grants
under subsection (a), there are authorized to be
appropriated $12,000,000 for fiscal year 2008, and such
sums as may be necessary for each of fiscal years 2009
through 2012.
(2) Availability.--Amounts appropriated under
paragraph (1) shall remain available until expended.
(j) Public Health Loan Repayment.--
(1) In general.--The Secretary may award grants to
States for the purpose of assisting such States in
operating loan repayment programs under which such
States enter into contracts to repay all or part of the
eligible loans borrowed by, or on behalf of,
individuals who agree to serve in State, local, or
tribal health departments that serve health
professional shortage areas or other areas at risk of a
public health emergency, as designated by the
Secretary.
(2) Loans eligible for repayment.--To be eligible
for repayment under this subsection, a loan shall be a
loan made, insured, or guaranteed by the Federal
Government that is borrowed by, or on behalf of, an
individual to pay the cost of attendance for a program
of education leading to a degree appropriate for
serving in a State, local, or tribal health department
as determined by the Secretary and the chief executive
officer of the State in which the grant is
administered, at an institution of higher education (as
defined in section 102 of the Higher Education Act of
1965), including principal, interest, and related
expenses on such loan.
(3) Applicability of existing requirements.--With
respect to awards made under paragraph (1)--
(A) the requirements of subsections (b),
(f), and (g) shall apply to such awards; and
(B) the requirements of subsection (c)
shall apply to such awards except that with
respect to paragraph (1) of such subsection,
the State involved may assign an individual
only to public and nonprofit private entities
that serve health professional shortage areas
or areas at risk of a public health emergency,
as determined by the Secretary.
(4) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection, such sums as may be necessary for each of
fiscal years 2007 through 2010.
SEC. 338J. [254R] GRANTS TO STATES FOR OPERATION OF OFFICES OF RURAL
HEALTH.
(a) In general.--The Secretary, action through the Director
of the Office of Rural Health Policy (established in section
711 of the Social Security Act), may make grants to States for
the purpose of improving health care in rural areas through the
operation of State offices of rural health.
(b) Requirement of Matching Funds.--
(1) In general.--The Secretary may not make a grant
under subsection (a) unless the State involved agrees,
with respect to the costs to be incurred by the State
in carrying out the purpose described in such
subsection, to provide non-Federal contributions toward
such costs in an amount equal to--
(A) for the first fiscal year of payments
under the grant, not less than $1 for each $3
of Federal funds provided in the grant;
(B) for any second fiscal year of such
payments, not less than $1 for each $1 of
Federal funds provided in the grant; and
(C) for any third fiscal year of such
payments, not less than $3 for each $1 of
Federal funds provided in the grant.
(2) Determination of amount of non-federal
contribution.--
(A) Subject to subparagraph (B), non-
Federal contributions required in paragraph (1)
may be in cash or in kind, fairly evaluated,
including plant, equipment, or services.
Amounts provided by the Federal Government, or
services assisted or subsidized to any
significant extent by the Federal Government,
may not be included in determining the amount
of such non-Federal contributions.
(B) The Secretary may not make a grant
under subsection (a) unless the State involved
agrees that--
(i) for the first fiscal year of
payments under the grant, 100 percent
or less of the non-Federal
contributions required in paragraph (1)
will be provided in the form of in-kind
contributions;
(ii) for any second fiscal year of
such payments, not more than 50 percent
of such non-Federal contributions will
be provided in the form of in-kind
contributions; and
(iii) for any third fiscal year of
such payments, such non-Federal
contributions will be provided solely
in the form of cash.
(c) Certain Required Activities.--The Secretary may not
make a grant under subsection (a) unless the State involved
agrees that activities carried out by an office operated
pursuant to such subsection will include--
(1) establishing and maintaining within the State a
clearinghouse for collecting and disseminating
information on--
(A) rural health care issues;
(B) research findings relating to rural
health care; and
(C) innovative approaches to the delivery
of health care in rural areas;
(2) coordinating the activities carried out in the
State that relate to rural health care, including
providing coordination for the purpose of avoiding
redundancy in such activities; and
(3) identifying Federal and State programs
regarding rural health, and providing technical
assistance to public and nonprofit private entities
regarding participation in such programs.
(d) Requirement Regarding Annual Budget for Office.--The
Secretary may not make a grant under subsection (a) unless the
State involved agrees that, for any fiscal year for which the
State receives such a grant, the office operated pursuant to
subsection (a) will be provided with an annual budget of not
less than $50,000.
(e) Certain Uses of Funds.--
(1) Restrictions.--The Secretary may not make a
grant under subsection (a) unless the State involved
agrees that--
(A) if research with respect to rural
health is conducted pursuant to the grant, not
more than 10 percent of the grant will be
expended for such research; and
(B) the grant will not be expended--
(i) to provide health care
(including providing cash payments
regarding such care);
(ii) to conduct activities for
which Federal funds are expended--
(I) within the State to
provide technical and other
nonfinancial assistance under
subsection (f) of section 330
\1\;
---------------------------------------------------------------------------
\1\ Probably should be ``subsection (k)''. See the amendment made
by section 2 of Public Law 104-299 (110 Stat. 3626).
---------------------------------------------------------------------------
(II) under a memorandum of
agreement entered into with the
State under subsection (h) of
such section; \2\ or
---------------------------------------------------------------------------
\2\ Probably should be ``subsection (m)''. See the amendment
referred to in footnote 1.
---------------------------------------------------------------------------
(III) under a grant under
section 338I;
(iii) to purchase medical
equipment, to purchase ambulances,
aircraft, or other vehicles, or to
purchase major communications
equipment;
(iv) to purchase or improve real
property; or
(v) to carry out any activity
regarding a certificate of need.
(2) Authorities.--Activities for which a State may
expend a grant under subsection (a) include--
(A) paying the costs of establishing an
office of rural health for purposes of
subsection (a);
(B) subject to paragraph (1)(B)(ii)(III),
paying the costs of any activity carried out
with respect to recruiting and retaining health
professionals to serve in rural areas of the
State; and
(C) providing grants and contracts to
public and nonprofit private entities to carry
out activities authorized in this section.
(f) Reports.--The Secretary may not make a grant under
subsection (a) unless the State involved agrees--
(1) to submit to the Secretary reports containing
such information as the Secretary may require regarding
activities carried out under this section by the State;
and
(2) to submit such a report not later than January
10 of each fiscal year immediately following any fiscal
year for which the State has received such a grant.
(g) Requirement of Application.--The Secretary may not make
a grant under subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in
such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary
determines to be necessary to carry out such subsection.
(h) Noncompliance.--The Secretary may not make payments
under subsection (a) to a State for any fiscal year subsequent
to the first fiscal year of such payments unless the Secretary
determines that, for the immediately preceding fiscal year, the
State has complied with each of the agreements made by the
State under this section.
(i) Definitions.--For purposes of this section, the term
``State'' means each of the several States.
(j) Authorization of Appropriations.--
(1) In general.--For the purpose of making grants
under subsection (a), there are authorized to be
appropriated $3,000,000 for fiscal year 1991,
$4,000,000 for fiscal year 1992, $3,000,000 for fiscal
year 1993, and such sums as may be necessary for each
of the fiscal years 1998 through 2002.
(2) Availability.--Amounts appropriated under
paragraph (1) shall remain available until expended.
(k) Termination of Program.--No grant may be made under
this section after the aggregate amounts appropriated under
subsection (j)(1) are equal to $36,000,000.
SEC. 338K. [254S] NATIVE HAWAIIAN HEALTH SCHOLARSHIPS.
(a) Subject to the availability of funds appropriated under
the authority of subsection (d), the Secretary shall provide
scholarship assistance, pursuant to a contract with the Papa
Ola Lokahi, to students who--
(1) meet the requirements of section 338A(b), and
(2) are Native Hawaiians.
(b)(1) The scholarship assistance provided under subsection
(a) shall be provided under the same terms and subject to the
same conditions, regulations, and rules that apply to
scholarship assistance provided under section 338A.
(2) The Native Hawaiian Health Scholarship program shall
not be administered by or through the Indian Health Service.
(c) For purposes of this section, the term ``Native
Hawaiian'' means any individual who is--
(1) a citizen of the United States,
(2) a resident of the State of Hawaii, and
(3) a descendant of the aboriginal people, who
prior to 1778, occupied and exercised sovereignty in
the area that now constitutes the State of Hawaii, as
evidenced by--
(A) genealogical records,
(B) Kupuna (elders) or Kama'aina (long-term
community residents) verification, or
(C) birth records of the State of Hawaii.
(d) There are authorized to be appropriated $1,800,000 for
each of the fiscal years 1990, 1991, and 1992 for the purpose
of funding the scholarship assistance provided under subsection
(a).
SEC. 338L. [254T] DEMONSTRATION PROJECT.
(a) Program Authorized.--The Secretary shall establish a
demonstration project to provide for the participation of
individuals who are chiropractic doctors or pharmacists in the
Loan Repayment Program described in section 338B.
(b) Procedure.--An individual that receives assistance
under this section with regard to the program described in
section 338B shall comply with all rules and requirements
described in such section (other than subparagraphs (A) and (B)
of section 338B(b)(1)) in order to receive assistance under
this section.
(c) Limitations.--
(1) In general.--The demonstration project
described in this section shall provide for the
participation of individuals who shall provide services
in rural and urban areas.
(2) Availability of other health professionals.--
The Secretary may not assign an individual receiving
assistance under this section to provide obligated
service at a site unless--
(A) the Secretary has assigned a physician
(as defined in section 1861(r) of the Social
Security Act) or other health professional
licensed to prescribe drugs to provide
obligated service at such site under section
338C or 338D; and
(B) such physician or other health
professional will provide obligated service at
such site concurrently with the individual
receiving assistance under this section.
(3) Rules of construction.--
(A) Supervision of individuals.--Nothing in
this section shall be construed to require or
imply that a physician or other health
professional licensed to prescribe drugs must
supervise an individual receiving assistance
under the demonstration project under this
section, with respect to such project.
(B) Licensure of health professionals.--
Nothing in this section shall be construed to
supersede State law regarding licensure of
health professionals.
(d) Designations.--The demonstration project described in
this section, and any providers who are selected to participate
in such project, shall not be considered by the Secretary in
the designation of a health professional shortage area under
section 332 during fiscal years 2002 through 2004.
(e) Rule of Construction.--This section shall not be
construed to require any State to participate in the project
described in this section.
(f) Report.--
(1) In general.--The Secretary shall evaluate the
participation of individuals in the demonstration
projects under this section and prepare and submit a
report containing the information described in
paragraph (2) to--
(A) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(B) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee
on Appropriations of the Senate;
(C) the Committee on Energy and Commerce of
the House of Representatives; and
(D) the Subcommittee on Labor, Health and
Human Services, and Education of the Committee
on Appropriations of the House of
Representatives.
(2) Content.--The report described in paragraph (1)
shall detail--
(A) the manner in which the demonstration
project described in this section has affected
access to primary care services, patient
satisfaction, quality of care, and health care
services provided for traditionally underserved
populations;
(B) how the participation of chiropractic
doctors and pharmacists in the Loan Repayment
Program might affect the designation of health
professional shortage areas; and
(C) whether adding chiropractic doctors and
pharmacists as permanent members of the
National Health Service Corps would be feasible
and would enhance the effectiveness of the
National Health Service Corps.
(g) Authorization of Appropriations.--
(1) in general.--There are authorized to be
appropriated to carry out this section, such sums as
may be necessary for fiscal years 2002 through 2004.
(2) Fiscal year 2005.--If the Secretary determines
and certifies to Congress by not later than September
30, 2004, that the number of individuals participating
in the demonstration project established under this
section is insufficient for purposes of performing the
evaluation described in subsection (f)(1), the
authorization of appropriations under paragraph (1)
shall be extended to include fiscal year 2005.
SEC. 338M. [254U] PUBLIC HEALTH DEPARTMENTS.
(a) In General.--To the extent that funds are appropriated
under subsection (e), the Secretary shall establish a
demonstration project to provide for the participation of
individuals who are eligible for the Loan Repayment Program
described in section 338B and who agree to complete their
service obligation in a State health department that provides a
significant amount of service to health professional shortage
areas or areas at risk of a public health emergency, as
determined by the Secretary, or in a local or tribal health
department that serves a health professional shortage area or
an area at risk of a public health emergency.
(b) Procedure.--To be eligible to receive assistance under
subsection (a), with respect to the program described in
section 338B, an individual shall--
(1) comply with all rules and requirements
described in such section (other than section
338B(f)(1)(B)(iv)); and
(2) agree to serve for a time period equal to 2
years, or such longer period as the individual may
agree to, in a State, local, or tribal health
department, described in subsection (a).
(c) Designations.--The demonstration project described in
subsection (a), and any healthcare providers who are selected
to participate in such project, shall not be considered by the
Secretary in the designation of health professional shortage
areas under section 332 during fiscal years 2007 through 2010.
(d) Report.--Not later than 3 years after the date of
enactment of this section, the Secretary shall submit a report
to the relevant committees of Congress that evaluates the
participation of individuals in the demonstration project under
subsection (a), the impact of such participation on State,
local, and tribal health departments, and the benefit and
feasibility of permanently allowing such placements in the Loan
Repayment Program.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, such sums as may
be necessary for each of fiscal years 2007 through 2010.
Subpart IV--Home Health Services
home health services
Sec. 339. [255] (a)(1) For the purpose of encouraging the
establishment and initial operation of home health programs to
provide home health services in areas in which such services
are inadequate or not readily accessible, the Secretary may, in
accordance with the provisions of this section, make grants to
public and nonprofit private entities and loans to proprietary
entities to meet the initial costs of establishing and
operating such home health programs. Such grants and loans may
include funds to provide training for paraprofessionals
(including homemaker home health aides) to provide home health
services.
(2) In making grants and loans under this subsection, the
Secretary shall--
(A) consider the relative needs of the several
States for home health services;
(B) give preference to areas in which a high
percentage of the population proposed to be served is
composed of individuals who are elderly, medically
indigent, or disabled; and
(C) give special consideration to areas with
inadequate means of transportation to obtain necessary
health services.
(3)(A) No loan may be made to a proprietary entity under
this section unless the application of such entity for such
loan contains assurances satisfactory to the Secretary that--
(i) at the time the application is made the entity
is fiscally sound;
(ii) the entity is unable to secure a loan for the
project for which the application is submitted from
non-Federal lenders at the rate of interest prevailing
in the area in which the entity is located; and
(iii) during the period of the loan, such entity
will remain fiscally sound.
(B) Loans under this section shall be made at an interest
rate comparable to the rate of interest prevailing on the date
the loan is made with respect to the marketable obligations of
the United States of comparable maturities, adjusted to provide
for administrative costs.
(4) Applications for grants and loans under this subsection
shall be in such form and contain such information as the
Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and
loans under this subsection $5,000,000 for each of the fiscal
years ending on September 30, 1983, September 30, 1984,
September 30, 1985, September 30, 1986, and September 30, 1987.
(b)(1) The Secretary may make grants to and enter into
contracts with public and private entities to assist them in
developing appropriate training programs for paraprofessionals
(including homemaker home health aides) to provide home health
services.
(2) Any program established with a grant or contract under
this subsection to train homemaker home health aides shall--
(A) extend for at least forty hours, and consist of
classroom instruction and at least twenty hours (in the
aggregate) of supervised clinical instruction directed
toward preparing students to deliver home health
services;
(B) be carried out under appropriate professional
supervision and be designed to train students to
maintain or enhance the personal care of an individual
in his home in a manner which promotes the functional
independence of the individual; and
(C) include training in--
(i) personal care services designed to
assist an individual in the activities of daily
living such as bathing, exercising, personal
grooming, and getting in and out of bed; and
(ii) household care services such as
maintaining a safe living environment, light
housekeeping, and assisting in providing good
nutrition (by the purchasing and preparation of
food).
(3) In making grants and entering into contracts under this
subsection, special consideration shall be given to entities
which establish or will establish programs to provide training
for persons fifty years of age and older who wish to become
paraprofessionals (including homemaker home health aides) to
provide home health services.
(4) Applications for grants and contracts under this
subsection shall be in such form and contain such information
as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and
contracts under this subsection $2,000,000 for each of the
fiscal years ending September 30, 1983, September 30, 1984,
September 30, 1985, September 30, 1986, and September 30, 1987.
(c) The Secretary shall report to the Committee on Labor
and Human Resources of the Senate and the Committee on Energy
and Commerce of the House of Representatives on or before
January 1, 1984, with respect to--
(1) the impact of grants made and contracts entered
into under subsections (a) and (b) (as such subsections
were in effect prior to October 1, 1981);
(2) the need to continue grants and loans under
subsections (a) and (b) (as such subsections are in
effect on the day after the date of enactment of the
Orphan Drug Act); and
(3) the extent to which standards have been applied
to the training of personnel who provide home health
services.
(d) For purposes of this section, the term ``home health
services'' has the meaning prescribed for the term by section
1861(m) of the Social Security Act.
Subpart V--Healthy Communities Access Program
SEC. 340. [256] GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFICIENCY, AND
COORDINATION OF SERVICES FOR THE UNINSURED AND
UNDERINSURED.
(a) In General.--The Secretary may award grants to eligible
entities to assist in the development of integrated health care
delivery systems to serve communities of individuals who are
uninsured and individuals who are underinsured--
(1) to improve the efficiency of, and coordination
among, the providers providing services through such
systems;
(2) to assist communities in developing programs
targeted toward preventing and managing chronic
diseases; and
(3) to expand and enhance the services provided
through such systems.
(b) Eligible Entities.--To be eligible to receive a grant
under this section, an entity shall be an entity that--
(1) represents a consortium--
(A) whose principal purpose is to provide a
broad range of coordinated health care services
for a community defined in the entity's grant
application as described in paragraph (2); and
(B) that includes at least one of each of
the following providers that serve the
community (unless such provider does not exist
within the community, declines or refuses to
participate, or places unreasonable conditions
on their participation)--
(i) a Federally qualified health
center (as defined in section 1861(aa)
of the Social Security Act (42 U.S.C.
1395x(aa)));
(ii) a hospital with a low-income
utilization rate (as defined in section
1923(b)(3) of the Social Security Act
(42 U.S.C. 1396r-4(b)(3)), that is
greater than 25 percent;
(iii) a public health department;
and
(iv) an interested public or
private sector health care provider or
an organization that has traditionally
served the medically uninsured and
underserved; and
(2) submits to the Secretary an application, in
such form and manner as the Secretary shall prescribe,
that--
(A) defines a community or geographic area
of uninsured and underinsured individuals;
(B) identifies the providers who will
participate in the consortium's program under
the grant, and specifies each provider's
contribution to the care of uninsured and
underinsured individuals in the community,
including the volume of care the provider
provides to beneficiaries under the medicare,
medicaid, and State child health insurance
programs and to patients who pay privately for
services;
(C) describes the activities that the
applicant and the consortium propose to perform
under the grant to further the objectives of
this section;
(D) demonstrates the consortium's ability
to build on the current system (as of the date
of submission of the application) for serving a
community or geographic area of uninsured and
underinsured individuals by involving providers
who have traditionally provided a significant
volume of care for that community;
(E) demonstrates the consortium's ability
to develop coordinated systems of care that
either directly provide or ensure the prompt
provision of a broad range of high-quality,
accessible services, including, as appropriate,
primary, secondary, and tertiary services, as
well as substance abuse treatment and mental
health services in a manner that assures
continuity of care in the community or
geographic area;
(F) provides evidence of community
involvement in the development, implementation,
and direction of the program that the entity
proposes to operate;
(G) demonstrates the consortium's ability
to ensure that individuals participating in the
program are enrolled in public insurance
programs for which the individuals are eligible
or know of private insurance programs where
available;
(H) presents a plan for leveraging other
sources of revenue, which may include State and
local sources and private grant funds, and
integrating current and proposed new funding
sources in a way to assure long-term
sustainability of the program;
(I) describes a plan for evaluation of the
activities carried out under the grant,
including measurement of progress toward the
goals and objectives of the program and the use
of evaluation findings to improve program
performance;
(J) demonstrates fiscal responsibility
through the use of appropriate accounting
procedures and appropriate management systems;
(K) demonstrates the consortium's
commitment to serve the community without
regard to the ability of an individual or
family to pay by arranging for or providing
free or reduced charge care for the poor; and
(L) includes such other information as the
Secretary may prescribe.
(c) Limitations.--
(1) Number of awards.--
(A) In general.--For each of fiscal years
2003, 2004, 2005, and 2006, the Secretary may
not make more than 35 new awards under
subsection (a) (excluding renewals of such
awards).
(B) Rule of construction.--This paragraph
shall not be construed to affect awards made
before fiscal year 2003.
(2) In general.--An eligible entity may not receive
a grant under this section (including with respect to
any such grant made before fiscal year 2003) for more
than 3 consecutive fiscal years, except that such
entity may receive such a grant award for not more than
1 additional fiscal year if--
(A) the eligible entity submits to the
Secretary a request for a grant for such an
additional fiscal year;
(B) the Secretary determines that
extraordinary circumstances (as defined in
paragraph (3)) justify the granting of such
request; and
(C) the Secretary determines that granting
such request is necessary to further the
objectives described in subsection (a).
(3) Extraordinary circumstances.--
(A) In general.--In paragraph (2), the term
``extraordinary circumstances'' means an event
(or events) that is outside of the control of
the eligible entity that has prevented the
eligible entity from fulfilling the objectives
described by such entity in the application
submitted under subsection (b)(2).
(B) Examples.--Extraordinary circumstances
include--
(i) natural disasters or other
major disruptions to the security or
health of the community or geographic
area served by the eligible entity; or
(ii) a significant economic
deterioration in the community or
geographic area served by such eligible
entity, that directly and adversely
affects the entity receiving an award
under subsection (a).
(d) Priorities.--In awarding grants under this section, the
Secretary--
(1) shall accord priority to applicants that
demonstrate the extent of unmet need in the community
involved for a more coordinated system of care; and
(2) may accord priority to applicants that best
promote the objectives of this section, taking into
consideration the extent to which the application
involved--
(A) identifies a community whose
geographical area has a high or increasing
percentage of individuals who are uninsured;
(B) demonstrates that the applicant has
included in its consortium providers, support
systems, and programs that have a tradition of
serving uninsured individuals and underinsured
individuals in the community;
(C) shows evidence that the program would
expand utilization of preventive and primary
care services for uninsured and underinsured
individuals and families in the community,
including behavioral and mental health
services, oral health services, or substance
abuse services;
(D) proposes a program that would improve
coordination between health care providers and
appropriate social service providers;
(E) demonstrates collaboration with State
and local governments;
(F) demonstrates that the applicant makes
use of non-Federal contributions to the
greatest extent possible; or
(G) demonstrates a likelihood that the
proposed program will continue after support
under this section ceases.
(e) Use of Funds.--
(1) Use by grantees.--
(A) In general.--Except as provided in
paragraphs (2) and (3), a grantee may use
amounts provided under this section only for--
(i) direct expenses associated with
achieving the greater integration of a
health care delivery system so that the
system either directly provides or
ensures the provision of a broad range
of culturally competent services, as
appropriate, including primary,
secondary, and tertiary services, as
well as substance abuse treatment and
mental health services; and
(ii) direct patient care and
service expansions to fill identified
or documented gaps within an integrated
delivery system.
(B) Specific uses.--The following are
examples of purposes for which a grantee may
use grant funds under this section, when such
use meets the conditions stated in subparagraph
(A):
(i) Increases in outreach
activities and closing gaps in health
care service.
(ii) Improvements to case
management.
(iii) Improvements to coordination
of transportation to health care
facilities.
(iv) Development of provider
networks and other innovative models to
engage physicians in voluntary efforts
to serve the medically underserved
within a community.
(v) Recruitment, training, and
compensation of necessary personnel.
(vi) Acquisition of technology for
the purpose of coordinating care.
(vii) Improvements to provider
communication, including implementation
of shared information systems or shared
clinical systems.
(viii) Development of common
processes for determining eligibility
for the programs provided through the
system, including creating common
identification cards and single sliding
scale discounts.
(ix) Development of specific
prevention and disease management tools
and processes.
(x) Translation services.
(xi) Carrying out other activities
that may be appropriate to a community
and that would increase access by the
uninsured to health care, such as
access initiatives for which private
entities provide non-Federal
contributions to supplement the Federal
funds provided through the grants for
the initiatives.
(2) Direct patient care limitation.--Not more than
15 percent of the funds provided under a grant awarded
under this section may be used for providing direct
patient care and services.
(3) Reservation of funds for national program
purposes.--The Secretary may use not more than 3
percent of funds appropriated to carry out this section
for providing technical assistance to grantees,
obtaining assistance of experts and consultants,
holding meetings, developing of tools, disseminating of
information, evaluation, and carrying out activities
that will extend the benefits of programs funded under
this section to communities other than the community
served by the program funded.
(f) Grantee Requirements.--
(1) Evaluation of effectiveness.--A grantee under
this section shall--
(A) report to the Secretary annually
regarding--
(i) progress in meeting the goals
and measurable objectives set forth in
the grant application submitted by the
grantee under subsection (b); and
(ii) the extent to which activities
conducted by such grantee have--
(I) improved the
effectiveness, efficiency, and
coordination of services for
uninsured and underinsured
individuals in the communities
or geographic areas served by
such grantee;
(II) resulted in the
provision of better quality
health care for such
individuals; and
(III) resulted in the
provision of health care to
such individuals at lower cost
than would have been possible
in the absence of the
activities conducted by such
grantee; and
(B) provide for an independent annual
financial audit of all records that relate to
the disposition of funds received through the
grant.
(2) Progress.--The Secretary may not renew an
annual grant under this section for an entity for a
fiscal year unless the Secretary is satisfied that the
consortium represented by the entity has made
reasonable and demonstrable progress in meeting the
goals and measurable objectives set forth in the
entity's grant application for the preceding fiscal
year.
(g) Maintenance of Effort.--With respect to activities for
which a grant under this section is authorized, the Secretary
may award such a grant only if the applicant for the grant, and
each of the participating providers, agree that the grantee and
each such provider will maintain its expenditures of non-
Federal funds for such activities at a level that is not less
than the level of such expenditures during the fiscal year
immediately preceding the fiscal year for which the applicant
is applying to receive such grant.
(h) Technical Assistance.--The Secretary may, either
directly or by grant or contract, provide any entity that
receives a grant under this section with technical and other
nonfinancial assistance necessary to meet the requirements of
this section.
(i) Evaluation of Program.--Not later than September 30,
2005, the Secretary shall prepare and submit to the appropriate
committees of Congress a report that describes the extent to
which projects funded under this section have been successful
in improving the effectiveness, efficiency, and coordination of
services for uninsured and underinsured individuals in the
communities or geographic areas served by such projects,
including whether the projects resulted in the provision of
better quality health care for such individuals, and whether
such care was provided at lower costs, than would have been
provided in the absence of such projects.
(j) Demonstration Authority.--The Secretary may make
demonstration awards under this section to historically black
health professions schools for the purposes of--
(1) developing patient-based research
infrastructure at historically black health professions
schools, which have an affiliation, or affiliations,
with any of the providers identified in subsection
(b)(1)(B);
(2) establishment of joint and collaborative
programs of medical research and data collection
between historically black health professions schools
and such providers, whose goal is to improve the health
status of medically underserved populations; or
(3) supporting the research-related costs of
patient care, data collection, and academic training
resulting from such affiliations.
(k) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2002 through 2006.
(l) Date Certain for Termination of Program.--Funds may not
be appropriated to carry out this section after September 30,
2006.
SEC. 340A. [256A] PATIENT NAVIGATOR GRANTS.
(a) Grants.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make grants to eligible entities for the
development and operation of demonstration programs to provide
patient navigator services to improve health care outcomes. The
Secretary shall coordinate with, and ensure the participation
of, the Indian Health Service, the National Cancer Institute,
the Office of Rural Health Policy, and such other offices and
agencies as deemed appropriate by the Secretary, regarding the
design and evaluation of the demonstration programs.
(b) Use of Funds.--The Secretary shall require each
recipient of a grant under this section to use the grant to
recruit, assign, train, and employ patient navigators who have
direct knowledge of the communities they serve to facilitate
the care of individuals, including by performing each of the
following duties:
(1) Acting as contacts, including by assisting in
the coordination of health care services and provider
referrals, for individuals who are seeking prevention
or early detection services for, or who following a
screening or early detection service are found to have
a symptom, abnormal finding, or diagnosis of, cancer or
other chronic disease.
(2) Facilitating the involvement of community
organizations in assisting individuals who are at risk
for or who have cancer or other chronic diseases to
receive better access to high-quality health care
services (such as by creating partnerships with patient
advocacy groups, charities, health care centers,
community hospice centers, other health care providers,
or other organizations in the targeted community).
(3) Notifying individuals of clinical trials and,
on request, facilitating enrollment of eligible
individuals in these trials.
(4) Anticipating, identifying, and helping patients
to overcome barriers within the health care system to
ensure prompt diagnostic and treatment resolution of an
abnormal finding of cancer or other chronic disease.
(5) Coordinating with the relevant health insurance
ombudsman programs to provide information to
individuals who are at risk for or who have cancer or
other chronic diseases about health coverage, including
private insurance, health care savings accounts, and
other publicly funded programs (such as Medicare,
Medicaid, health programs operated by the Department of
Veterans Affairs or the Department of Defense, the
State children's health insurance program, and any
private or governmental prescription assistance
programs).
(6) Conducting ongoing outreach to health disparity
populations, including the uninsured, rural
populations, and other medically underserved
populations, in addition to assisting other individuals
who are at risk for or who have cancer or other chronic
diseases to seek preventative care.
(c) Prohibitions.--
(1) Referral fees.--The Secretary shall require
each recipient of a grant under this section to
prohibit any patient navigator providing services under
the grant from accepting any referral fee, kickback, or
other thing of value in return for referring an
individual to a particular health care provider.
(2) Legal fees and costs.--The Secretary shall
prohibit the use of any grant funds received under this
section to pay any fees or costs resulting from any
litigation, arbitration, mediation, or other proceeding
to resolve a legal dispute.
(d) Grant Period.--
(1) In general.--Subject to paragraphs (2) and (3),
the Secretary may award grants under this section for
periods of not more than 3 years.
(2) Extensions.--Subject to paragraph (3), the
Secretary may extend the period of a grant under this
section. Each such extension shall be for a period of
not more than 1 year.
(3) Limitations on grant period.--In carrying out
this section, the Secretary shall ensure that the total
period of a grant does not exceed 4 years.
(e) Application.--
(1) In general.--To seek a grant under this
section, an eligible entity shall submit an application
to the Secretary in such form, in such manner, and
containing such information as the Secretary may
require.
(2) Contents.--At a minimum, the Secretary shall
require each such application to outline how the
eligible entity will establish baseline measures and
benchmarks that meet the Secretary's requirements to
evaluate program outcomes.
(3) Minimum core proficiencies.--The Secretary
shall not award a grant to an entity under this section
unless such entity provides assurances that patient
navigators recruited, assigned, trained, or employed
using grant funds meet minimum core proficiencies, as
defined by the entity that submits the application,
that are tailored for the main focus or intervention of
the navigator involved.
(f) Uniform Baseline Measures.--The Secretary shall
establish uniform baseline measures in order to properly
evaluate the impact of the demonstration projects under this
section.
(g) Preference.--In making grants under this section, the
Secretary shall give preference to eligible entities that
demonstrate in their applications plans to utilize patient
navigator services to overcome significant barriers in order to
improve health care outcomes in their respective communities.
(h) Duplication of Services.--An eligible entity that is
receiving Federal funds for activities described in subsection
(b) on the date on which the entity submits an application
under subsection (e) may not receive a grant under this section
unless the entity can demonstrate that amounts received under
the grant will be utilized to expand services or provide new
services to individuals who would not otherwise be served.
(i) Coordination With Other Programs.--The Secretary shall
ensure coordination of the demonstration grant program under
this section with existing authorized programs in order to
facilitate access to high-quality health care services.
(j) Study; Reports.--
(1) Final report by secretary.--Not later than 6
months after the completion of the demonstration grant
program under this section, the Secretary shall conduct
a study of the results of the program and submit to the
Congress a report on such results that includes the
following:
(A) An evaluation of the program outcomes,
including--
(i) quantitative analysis of
baseline and benchmark measures; and
(ii) aggregate information about
the patients served and program
activities.
(B) Recommendations on whether patient
navigator programs could be used to improve
patient outcomes in other public health areas.
(2) Interim reports by secretary.--The Secretary
may provide interim reports to the Congress on the
demonstration grant program under this section at such
intervals as the Secretary determines to be
appropriate.
(3) Reports by grantees.--The Secretary may require
grant recipients under this section to submit interim
and final reports on grant program outcomes.
(k) Rule of Construction.--This section shall not be
construed to authorize funding for the delivery of health care
services (other than the patient navigator duties listed in
subsection (b)).
(l) Definitions.--In this section:
(1) The term ``eligible entity'' means a public or
nonprofit private health center (including a Federally
qualified health center (as that term is defined in
section 1861(aa)(4) of the Social Security Act)), a
health facility operated by or pursuant to a contract
with the Indian Health Service, a hospital, a cancer
center, a rural health clinic, an academic health
center, or a nonprofit entity that enters into a
partnership or coordinates referrals with such a
center, clinic, facility, or hospital to provide
patient navigator services.
(2) The term ``health disparity population'' means
a population that, as determined by the Secretary, has
a significant disparity in the overall rate of disease
incidence, prevalence, morbidity, mortality, or
survival rates as compared to the health status of the
general population.
(3) The term ``patient navigator'' means an
individual who has completed a training program
approved by the Secretary to perform the duties listed
in subsection (b).
(m) Authorization of Appropriations.--
(1) In general.--To carry out this section, there
are authorized to be appropriated $2,000,000 for fiscal
year 2006, $5,000,000 for fiscal year 2007, $8,000,000
for fiscal year 2008, $6,500,000 for fiscal year 2009,
$3,500,000 for fiscal year 2010, and such sums as may
be necessary for each of fiscal years 2011 through
2015.
(2) Availability.--The amounts appropriated
pursuant to paragraph (1) shall remain available for
obligation through the end of fiscal year 2015.
Subpart VII--Drug Pricing Agreements \1\
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\1\ So in law. Former subpart VI was repealed by section 4(a)(3) of
Public Law 104-299 (110 Stat. 3645).
---------------------------------------------------------------------------
limitation on prices of drugs purchased by covered entities
Sec. 340B. [256b] (a) Requirements for Agreement With
Secretary.--
(1) In general.--The Secretary shall enter into an
agreement with each manufacturer of covered outpatient
drugs under which the amount required to be paid
(taking into account any rebate or discount, as
provided by the Secretary) to the manufacturer for
covered outpatient drugs (other than drugs described in
paragraph (3)) purchased by a covered entity on or
after the first day of the first month that begins
after the date of the enactment of this section, does
not exceed an amount equal to the average manufacturer
price for the drug under title XIX of the Social
Security Act in the preceding calendar quarter, reduced
by the rebate percentage described in paragraph (2).
Each such agreement shall require that the manufacturer
furnish the Secretary with reports, on a quarterly
basis, of the price for each covered outpatient drug
subject to the agreement that, according to the
manufacturer, represents the maximum price that covered
entities may permissibly be required to pay for the
drug (referred to in this section as the ``ceiling
price''), and shall require that the manufacturer offer
each covered entity covered outpatient drugs for
purchase at or below the applicable ceiling price if
such drug is made available to any other purchaser at
any price.
(2) Rebate percentage defined.--
(A) In general.--For a covered outpatient
drug purchased in a calendar quarter, the
``rebate percentage'' is the amount (expressed
as a percentage) equal to--
(i) the average total rebate
required under section 1927(c) of the
Social Security Act with respect to the
drug (for a unit of the dosage form and
strength involved) during the preceding
calendar quarter; divided by
(ii) the average manufacturer price
for such a unit of the drug during such
quarter.
(B) Over the counter drugs.--
(i) In general.--For purposes of
subparagraph (A), in the case of over
the counter drugs, the ``rebate
percentage'' shall be determined as if
the rebate required under section
1927(c) of the Social Security Act is
based on the applicable percentage
provided under section 1927(c)(3) of
such Act.
(ii) Definition.--The term ``over
the counter drug'' means a drug that
may be sold without a prescription and
which is prescribed by a physician (or
other persons authorized to prescribe
such drug under State law).
(3) Drugs provided under state medicaid plans.--
Drugs described in this paragraph are drugs purchased
by the entity for which payment is made by the State
under the State plan for medical assistance under title
XIX of the Social Security Act.
(4) Covered entity defined.--In this section, the
term ``covered entity'' means an entity that meets the
requirements described in paragraph (5) and is one of
the following:
(A) A Federally-qualified health center (as
defined in section 1905(l)(2)(B) of the Social
Security Act).
(B) An entity receiving a grant under
section 340A \1\.
---------------------------------------------------------------------------
\1\ See footnote on preceding page. See also footnote for section
217(a).
---------------------------------------------------------------------------
(C) A family planning project receiving a
grant or contract under section 1001.
(D) An entity receiving a grant under
subpart II of part C of title XXVI (relating to
categorical grants for outpatient early
intervention services for HIV disease).
(E) A State-operated AIDS drug purchasing
assistance program receiving financial
assistance under title XXVI.
(F) A black lung clinic receiving funds
under section 427(a) of the Black Lung Benefits
Act.
(G) A comprehensive hemophilia diagnostic
treatment center receiving a grant under
section 501(a)(2) of the Social Security Act.
(H) A Native Hawaiian Health Center
receiving funds under the Native Hawaiian
Health Care Act of 1988.
(I) An urban Indian organization receiving
funds under title V of the Indian Health Care
Improvement Act.
(J) Any entity receiving assistance under
title XXVI (other than a State or unit of local
government or an entity described in
subparagraph (D)), but only if the entity is
certified by the Secretary pursuant to
paragraph (7).
(K) An entity receiving funds under section
318 (relating to treatment of sexually
transmitted diseases) or section 317(j)(2)
(relating to treatment of tuberculosis) through
a State or unit of local government, but only
if the entity is certified by the Secretary
pursuant to paragraph (7).
(L) A subsection (d) hospital (as defined
in section 1886(d)(1)(B) of the Social Security
Act) that--
(i) is owned or operated by a unit
of State or local government, is a
public or private non-profit
corporation which is formally granted
governmental powers by a unit of State
or local government, or is a private
non-profit hospital which has a
contract with a State or local
government to provide health care
services to low income individuals who
are not entitled to benefits under
title XVIII of the Social Security Act
or eligible for assistance under the
State plan under this title;
(ii) for the most recent cost
reporting period that ended before the
calendar quarter involved, had a
disproportionate share adjustment
percentage (as determined under section
1886(d)(5)(F) of the Social Security
Act) greater than 11.75 percent or was
described in section
1886(d)(5)(F)(i)(II) of such Act; and
(iii) does not obtain covered
outpatient drugs through a group
purchasing organization or other group
purchasing arrangement.
(M) A children's hospital excluded from the
Medicare prospective payment system pursuant to
section 1886(d)(1)(B)(iii) of the Social
Security Act, or a free-standing cancer
hospital excluded from the Medicare prospective
payment system pursuant to section
1886(d)(1)(B)(v) of the Social Security Act,
that would meet the requirements of
subparagraph (L), including the
disproportionate share adjustment percentage
requirement under clause (ii) of such
subparagraph, if the hospital were a subsection
(d) hospital as defined by section
1886(d)(1)(B) of the Social Security Act.
(N) An entity that is a critical access
hospital (as determined under section
1820(c)(2) of the Social Security Act), and
that meets the requirements of subparagraph
(L)(i).
(O) An entity that is a rural referral
center, as defined by section 1886(d)(5)(C)(i)
of the Social Security Act, or a sole community
hospital, as defined by section
1886(d)(5)(C)(iii) of such Act, and that both
meets the requirements of subparagraph (L)(i)
and has a disproportionate share adjustment
percentage equal to or greater than 8 percent.
(5) Requirements for covered entities.--
(A) Prohibiting duplicate discounts or
rebates.--
(i) In general.--A covered entity
shall not request payment under title
XIX of the Social Security Act for
medical assistance described in section
1905(a)(12) of such Act with respect to
a drug that is subject to an agreement
under this section if the drug is
subject to the payment of a rebate to
the State under section 1927 of such
Act.
(ii) Establishment of mechanism.--
The Secretary shall establish a
mechanism to ensure that covered
entities comply with clause (i). If the
Secretary does not establish a
mechanism within 12 months under the
previous sentence, the requirements of
section 1927(a)(5)(C) of the Social
Security Act shall apply.
(B) Prohibiting resale of drugs.--With
respect to any covered outpatient drug that is
subject to an agreement under this subsection,
a covered entity shall not resell or otherwise
transfer the drug to a person who is not a
patient of the entity.
(C) Auditing.--A covered entity shall
permit the Secretary and the manufacturer of a
covered outpatient drug that is subject to an
agreement under this subsection with the entity
(acting in accordance with procedures
established by the Secretary relating to the
number, duration, and scope of audits) to audit
at the Secretary's or the manufacturer's
expense the records of the entity that directly
pertain to the entity's compliance with the
requirements described in subparagraphs (A) or
(B) with respect to drugs of the manufacturer.
(D) Additional sanction for
noncompliance.--If the Secretary finds, after
audit as described in subparagraph (C) and
after notice and hearing, that a covered entity
is in violation of a requirement described in
subparagraphs \1\ (A) or (B), the covered
entity shall be liable to the manufacturer of
the covered outpatient drug that is the subject
of the violation in an amount equal to the
reduction in the price of the drug (as
described in subparagraph (A)) provided under
the agreement between the entity and the
manufacturer under this paragraph.
---------------------------------------------------------------------------
\1\ So in law. See section 602(a) of Public Law 102-585 (106 Stat.
4967). Probably should be ``subparagraph''.
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(6) Treatment of distinct units of hospitals.--In
the case of a covered entity that is a distinct part of
a hospital, the hospital shall not be considered a
covered entity under this paragraph unless the hospital
is otherwise a covered entity under this subsection.
(7) Certification of certain covered entities.--
(A) Development of process.--Not later than
60 days after the date of enactment of this
subsection, the Secretary shall develop and
implement a process for the certification of
entities described in subparagraphs (J) and (K)
of paragraph (4).
(B) Inclusion of purchase information.--The
process developed under subparagraph (A) shall
include a requirement that an entity applying
for certification under this paragraph submit
information to the Secretary concerning the
amount such entity expended for covered
outpatient drugs in the preceding year so as to
assist the Secretary in evaluating the validity
of the entity's subsequent purchases of covered
outpatient drugs at discounted prices.
(C) Criteria.--The Secretary shall make
available to all manufacturers of covered
outpatient drugs a description of the criteria
for certification under this paragraph.
(D) List of purchasers and dispensers.--The
certification process developed by the
Secretary under subparagraph (A) shall include
procedures under which each State shall, not
later than 30 days after the submission of the
descriptions under subparagraph (C), prepare
and submit a report to the Secretary that
contains a list of entities described in
subparagraphs (J) and (K) of paragraph (4) that
are located in the State.
(E) Recertification.--The Secretary shall
require the recertification of entities
certified pursuant to this paragraph on a not
more frequent than annual basis, and shall
require that such entities submit information
to the Secretary to permit the Secretary to
evaluate the validity of subsequent purchases
by such entities in the same manner as that
required under subparagraph (B).
(8) Development of prime vendor program.--The
Secretary shall establish a prime vendor program under
which covered entities may enter into contracts with
prime vendors for the distribution of covered
outpatient drugs. If a covered entity obtains drugs
directly from a manufacturer, the manufacturer shall be
responsible for the costs of distribution.
(9) Notice to manufacturers.--The Secretary shall
notify manufacturers of covered outpatient drugs and
single State agencies under section 1902(a)(5) of the
Social Security Act of the identities of covered
entities under this paragraph, and of entities that no
longer meet the requirements of paragraph (5) or that
are no longer certified pursuant to paragraph (7).
(10) No prohibition on larger discount.--Nothing in
this subsection shall prohibit a manufacturer from
charging a price for a drug that is lower than the
maximum price that may be charged under paragraph (1).
(b) Other Definitions \1\.--
---------------------------------------------------------------------------
\1\ The amendment made by section 7101(b)(2)(A) of Public Law 111-
148 strikes ``Other Definition'' and all that follows through ``In this
section'' and inserts ``Other Definitions.--
---------------------------------------------------------------------------
(1) In general.--In this section''.
The heading of such amendment should have been to strike ``Other
Definitions''. The amendment made by such section has been carried out
to reflect the probable intent of Congress.
---------------------------------------------------------------------------
(1) In general.--In this section, the terms
``average manufacturer price'', ``covered outpatient
drug'', and ``manufacturer'' have the meaning given
such terms in section 1927(k) of the Social Security
Act.
(2) \2\ Covered drug.--In this section, the term
``covered drug''--
---------------------------------------------------------------------------
\2\ There are no references to the term ``covered drug'' in this
section.
---------------------------------------------------------------------------
(A) means a covered outpatient drug (as
defined in section 1927(k)(2) of the Social
Security Act); and
(B) includes, notwithstanding paragraph
(3)(A) of section 1927(k) of such Act, a drug
used in connection with an inpatient or
outpatient service provided by a hospital
described in subparagraph (L), (M), (N), or (O)
of subsection (a)(4) that is enrolled to
participate in the drug discount program under
this section.
(d) \3\ Improvements in Program Integrity.--
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\3\ In law, there is no subsection (c) in section 340B of the
Public Health Service Act. Subsection (d) of section 340B of the Public
Health Service, as in effect before the enactment of Public Law 111-
148, was redesignated as subsection (c) by section 2501(f)(1)(C) of
Public Law 111-148, amended to read by section 7101(d) of Public Law
111-148, and stricken by section 2302(2) of Public Law 111-152.
Subsection (d) of section 340B of the Public Health Service, as
currently in effect, is shown according to the probable intent of the
Congress. Section 7102(a) of Public Law 111-148 does not execute
because it amends to read a nonexistent subsection (d). Notably,
section 2302(3) of Public Law 111-152 assumes that section 7102(a) of
Public Law 111-148 executed properly and makes amendments to subsection
(d).
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(1) Manufacturer compliance.--
(A) In general.--From amounts appropriated
under paragraph (4), the Secretary shall
provide for improvements in compliance by
manufacturers with the requirements of this
section in order to prevent overcharges and
other violations of the discounted pricing
requirements specified in this section.
(B) Improvements.--The improvements
described in subparagraph (A) shall include the
following:
(i) The development of a system to
enable the Secretary to verify the
accuracy of ceiling prices calculated
by manufacturers under subsection
(a)(1) and charged to covered entities,
which shall include the following:
(I) Developing and
publishing through an
appropriate policy or
regulatory issuance, precisely
defined standards and
methodology for the calculation
of ceiling prices under such
subsection.
(II) Comparing regularly
the ceiling prices calculated
by the Secretary with the
quarterly pricing data that is
reported by manufacturers to
the Secretary.
(III) Performing spot
checks of sales transactions by
covered entities.
(IV) Inquiring into the
cause of any pricing
discrepancies that may be
identified and either taking,
or requiring manufacturers to
take, such corrective action as
is appropriate in response to
such price discrepancies.
(ii) The establishment of
procedures for manufacturers to issue
refunds to covered entities in the
event that there is an overcharge by
the manufacturers, including the
following:
(I) Providing the Secretary
with an explanation of why and
how the overcharge occurred,
how the refunds will be
calculated, and to whom the
refunds will be issued.
(II) Oversight by the
Secretary to ensure that the
refunds are issued accurately
and within a reasonable period
of time, both in routine
instances of retroactive
adjustment to relevant pricing
data and exceptional
circumstances such as erroneous
or intentional overcharging for
covered outpatient drugs.
(iii) The provision of access
through the Internet website of the
Department of Health and Human Services
to the applicable ceiling prices for
covered outpatient drugs as calculated
and verified by the Secretary in
accordance with this section, in a
manner (such as through the use of
password protection) that limits such
access to covered entities and
adequately assures security and
protection of privileged pricing data
from unauthorized re-disclosure.
(iv) The development of a mechanism
by which--
(I) rebates and other
discounts provided by
manufacturers to other
purchasers subsequent to the
sale of covered outpatient
drugs to covered entities are
reported to the Secretary; and
(II) appropriate credits
and refunds are issued to
covered entities if such
discounts or rebates have the
effect of lowering the
applicable ceiling price for
the relevant quarter for the
drugs involved.
(v) Selective auditing of
manufacturers and wholesalers to ensure
the integrity of the drug discount
program under this section.
(vi) The imposition of sanctions in
the form of civil monetary penalties,
which--
(I) shall be assessed
according to standards
established in regulations to
be promulgated by the Secretary
not later than 180 days after
the date of enactment of the
Patient Protection and
Affordable Care Act;
(II) shall not exceed
$5,000 for each instance of
overcharging a covered entity
that may have occurred; and
(III) shall apply to any
manufacturer with an agreement
under this section that
knowingly and intentionally
charges a covered entity a
price for purchase of a drug
that exceeds the maximum
applicable price under
subsection (a)(1).
(2) Covered entity compliance.--
(A) In general.--From amounts appropriated
under paragraph (4), the Secretary shall
provide for improvements in compliance by
covered entities with the requirements of this
section in order to prevent diversion and
violations of the duplicate discount provision
and other requirements specified under
subsection (a)(5).
(B) Improvements.--The improvements
described in subparagraph (A) shall include the
following:
(i) The development of procedures
to enable and require covered entities
to regularly update (at least annually)
the information on the Internet website
of the Department of Health and Human
Services relating to this section.
(ii) The development of a system
for the Secretary to verify the
accuracy of information regarding
covered entities that is listed on the
website described in clause (i).
(iii) The development of more
detailed guidance describing
methodologies and options available to
covered entities for billing covered
outpatient drugs to State Medicaid
agencies in a manner that avoids
duplicate discounts pursuant to
subsection (a)(5)(A).
(iv) The establishment of a single,
universal, and standardized
identification system by which each
covered entity site can be identified
by manufacturers, distributors, covered
entities, and the Secretary for
purposes of facilitating the ordering,
purchasing, and delivery of covered
outpatient drugs under this section,
including the processing of chargebacks
for such drugs.
(v) The imposition of sanctions, in
appropriate cases as determined by the
Secretary, additional to those to which
covered entities are subject under
subsection (a)(5)(D), through one or
more of the following actions:
(I) Where a covered entity
knowingly and intentionally
violates subsection (a)(5)(B),
the covered entity shall be
required to pay a monetary
penalty to a manufacturer or
manufacturers in the form of
interest on sums for which the
covered entity is found liable
under subsection (a)(5)(D),
such interest to be compounded
monthly and equal to the
current short term interest
rate as determined by the
Federal Reserve for the time
period for which the covered
entity is liable.
(II) Where the Secretary
determines a violation of
subsection (a)(5)(B) was
systematic and egregious as
well as knowing and
intentional, removing the
covered entity from the drug
discount program under this
section and disqualifying the
entity from re-entry into such
program for a reasonable period
of time to be determined by the
Secretary.
(III) Referring matters to
appropriate Federal authorities
within the Food and Drug
Administration, the Office of
Inspector General of Department
of Health and Human Services,
or other Federal agencies for
consideration of appropriate
action under other Federal
statutes, such as the
Prescription Drug Marketing Act
(21 U.S.C. 353).
(3) Administrative dispute resolution process.--
(A) In general.--Not later than 180 days
after the date of enactment of the Patient
Protection and Affordable Care Act, the
Secretary shall promulgate regulations to
establish and implement an administrative
process for the resolution of claims by covered
entities that they have been overcharged for
drugs purchased under this section, and claims
by manufacturers, after the conduct of audits
as authorized by subsection (a)(5)(C), of
violations of subsections (a)(5)(A) or
(a)(5)(B), including appropriate procedures for
the provision of remedies and enforcement of
determinations made pursuant to such process
through mechanisms and sanctions described in
paragraphs (1)(B) and (2)(B).
(B) Deadlines and procedures.--Regulations
promulgated by the Secretary under subparagraph
(A) shall--
(i) designate or establish a
decision-making official or decision-
making body within the Department of
Health and Human Services to be
responsible for reviewing and finally
resolving claims by covered entities
that they have been charged prices for
covered outpatient drugs in excess of
the ceiling price described in
subsection (a)(1), and claims by
manufacturers that violations of
subsection (a)(5)(A) or (a)(5)(B) have
occurred;
(ii) establish such deadlines and
procedures as may be necessary to
ensure that claims shall be resolved
fairly, efficiently, and expeditiously;
(iii) establish procedures by which
a covered entity may discover and
obtain such information and documents
from manufacturers and third parties as
may be relevant to demonstrate the
merits of a claim that charges for a
manufacturer's product have exceeded
the applicable ceiling price under this
section, and may submit such documents
and information to the administrative
official or body responsible for
adjudicating such claim;
(iv) require that a manufacturer
conduct an audit of a covered entity
pursuant to subsection (a)(5)(C) as a
prerequisite to initiating
administrative dispute resolution
proceedings against a covered entity;
(v) permit the official or body
designated under clause (i), at the
request of a manufacturer or
manufacturers, to consolidate claims
brought by more than one manufacturer
against the same covered entity where,
in the judgment of such official or
body, consolidation is appropriate and
consistent with the goals of fairness
and economy of resources; and
(vi) include provisions and
procedures to permit multiple covered
entities to jointly assert claims of
overcharges by the same manufacturer
for the same drug or drugs in one
administrative proceeding, and permit
such claims to be asserted on behalf of
covered entities by associations or
organizations representing the
interests of such covered entities and
of which the covered entities are
members.
(C) Finality of administrative
resolution.--The administrative resolution of a
claim or claims under the regulations
promulgated under subparagraph (A) shall be a
final agency decision and shall be binding upon
the parties involved, unless invalidated by an
order of a court of competent jurisdiction.
(4) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection, such sums as may be necessary for fiscal
year 2010 and each succeeding fiscal year.
(e) \1\ Exclusion of Orphan Drugs for Certain Covered
Entities.--For covered entities described in subparagraph (M)
(other than a children's hospital described in subparagraph
(M)), (N), or (O) of subsection (a)(4), the term ``covered
outpatient drug'' shall not include a drug designated by the
Secretary under section 526 of the Federal Food, Drug, and
Cosmetic Act for a rare disease or condition.
---------------------------------------------------------------------------
\1\ Subsection (e) is shown according to the probable intent of
Congress. Section 2302(4) of Public Law 111-152 inserts subsection (e)
``after subsection (d)''. See note in section 340B(d) of the Public
Health Service Act regarding the inclusion of subsection (d) to reflect
the probable intent of Congress.
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Subpart VIII--Bulk Purchases of Vaccines for Certain Programs
bulk purchases of vaccines for certain programs
Sec. 340C. [256c] (a) Agreements for Purchases.--
(1) In general.--Not later than 180 days after the
date of the enactment of the Preventive Health
Amendments of 1992 \1\, the Secretary, acting through
the Director of the Centers for Disease Control and
Prevention and in consultation with the Administrator
of the Health Resources and Services Administration,
shall enter into negotiations with manufacturers of
vaccines for the purpose of establishing and
maintaining agreements under which entities described
in paragraph (2) may purchase vaccines from the
manufacturers at the prices specified in the
agreements.
---------------------------------------------------------------------------
\1\ Enacted October 27, 1992.
---------------------------------------------------------------------------
(2) Relevant entities.--The entities referred to in
paragraph (1) are entities that provide immunizations
against vaccine-preventable diseases with assistance
provided under section 330.
(b) Negotiation of Prices.--In carrying out subsection (a),
the Secretary shall, to the extent practicable, ensure that the
prices provided for in agreements under such subsection are
comparable to the prices provided for in agreements negotiated
by the Secretary on behalf of grantees under section 317(j)(1).
(c) Authority of Secretary.--In carrying out subsection
(a), the Secretary, in the discretion of the Secretary, may
enter into the agreements described in such subsection (and may
decline to enter into such agreements), may modify such
agreements, may extend such agreements, and may terminate such
agreements.
(d) Rule of Construction.--This section may not be
construed as requiring any State to reduce or terminate the
supply of vaccines provided by the State to any of the entities
described in subsection (a)(2).
breast and cervical cancer information
Sec. 340D. [256d] (a) In General.--As a condition of
receiving grants, cooperative agreements, or contracts under
this Act, each of the entities specified in subsection (c)
shall, to the extent determined to be appropriate by the
Secretary, make available information concerning breast and
cervical cancer.
(b) Certain Authorities.--In carrying out subsection (a),
an entity specified in subsection (c)--
(1) may make the information involved available to
such individuals as the entity determines appropriate;
(2) may, as appropriate, provide information under
subsection (a) on the need for self-examination of the
breasts and on the skills for such self-examinations;
(3) shall provide information under subsection (a)
in the language and cultural context most appropriate
to the individuals to whom the information is provided;
and
(4) shall refer such clients as the entities
determine appropriate for breast and cervical cancer
screening, treatment, or other appropriate services.
(c) Relevant Entities.--The entities specified in this
subsection are the following:
(1) Entities receiving assistance under section
317F (relating to tuberculosis) \1\.
---------------------------------------------------------------------------
\1\ The reference to section 317F is so in law. See section 2502(b)
of Public Law 106-310 (114 Stat. 1163). Section 317E relates to
tuberculosis, not section 317F.
---------------------------------------------------------------------------
(2) Entities receiving assistance under section 318
(relating to sexually transmitted diseases).
(3) Migrant health centers receiving assistance
under section 329 \2\.
---------------------------------------------------------------------------
\2\ See footnote for section 217(a).
---------------------------------------------------------------------------
(4) Community health centers receiving assistance
under section 330 \2\.
(5) Entities receiving assistance under section
330(h) (relating to homeless individuals).
(6) Entities receiving assistance under section
340A \2\ (relating to health services for residents of
public housing).
(7) Entities providing services with assistance
under title V or title XIX.
(8) Entities receiving assistance under section
1001 (relating to family planning).
(9) Entities receiving assistance under title XXVI
(relating to services with respect to acquired immune
deficiency syndrome).
(10) Non-Federal entities authorized under the
Indian Self-Determination Act.
Subpart IX--Support of Graduate Medical Education Programs in
Children's Hospitals
SEC. 340E. [256E] PROGRAM OF PAYMENTS TO CHILDREN'S HOSPITALS THAT
OPERATE GRADUATE MEDICAL EDUCATION PROGRAMS.
(a) Payments.--The Secretary shall make two payments under
this section to each children's hospital for each of fiscal
years 2000 through 2005 and each of fiscal years 2007 through
2011, one for the direct expenses and the other for indirect
expenses associated with operating approved graduate medical
residency training programs. The Secretary shall promulgate
regulations pursuant to the rulemaking requirements of title 5,
United States Code, which shall govern payments made under this
subpart.
(b) Amount of Payments.--
(1) In general.--Subject to paragraphs (2) and (3),
the amounts payable under this section to a children's
hospital for an approved graduate medical residency
training program for a fiscal year are each of the
following amounts:
(A) Direct expense amount.--The amount
determined under subsection (c) for direct
expenses associated with operating approved
graduate medical residency training programs.
(B) Indirect expense amount.--The amount
determined under subsection (d) for indirect
expenses associated with the treatment of more
severely ill patients and the additional costs
relating to teaching residents in such
programs.
(2) Capped amount.--
(A) In general.--The total of the payments
made to children's hospitals under paragraph
(1)(A) or paragraph (1)(B) in a fiscal year
shall not exceed the funds appropriated under
paragraph (1) or (2), respectively, of
subsection (f) for such payments for that
fiscal year.
(B) Pro rata reductions of payments for
direct expenses.--If the Secretary determines
that the amount of funds appropriated under
subsection (f)(1) for a fiscal year is
insufficient to provide the total amount of
payments otherwise due for such periods under
paragraph (1)(A), the Secretary shall reduce
the amounts so payable on a pro rata basis to
reflect such shortfall.
(3) Annual reporting required.--
(A) Reduction in payment for failure to
report.--
(i) In general.--The amount payable
under this section to a children's
hospital for a fiscal year (beginning
with fiscal year 2008 and after taking
into account paragraph (2)) shall be
reduced by 25 percent if the Secretary
determines that--
(I) the hospital has failed
to provide the Secretary, as an
addendum to the hospital's
application under this section
for such fiscal year, the
report required under
subparagraph (B) for the
previous fiscal year; or
(II) such report fails to
provide the information
required under any clause of
such subparagraph.
(ii) Notice and opportunity to
provide missing information.--Before
imposing a reduction under clause (i)
on the basis of a hospital's failure to
provide information described in clause
(i)(II), the Secretary shall provide
notice to the hospital of such failure
and the Secretary's intention to impose
such reduction and shall provide the
hospital with the opportunity to
provide the required information within
a period of 30 days beginning on the
date of such notice. If the hospital
provides such information within such
period, no reduction shall be made
under clause (i) on the basis of the
previous failure to provide such
information.
(B) Annual report.--The report required
under this subparagraph for a children's
hospital for a fiscal year is a report that
includes (in a form and manner specified by the
Secretary) the following information for the
residency academic year completed immediately
prior to such fiscal year:
(i) The types of resident training
programs that the hospital provided for
residents described in subparagraph
(C), such as general pediatrics,
internal medicine/pediatrics, and
pediatric subspecialties, including
both medical subspecialties certified
by the American Board of Pediatrics
(such as pediatric gastroenterology)
and non-medical subspecialties approved
by other medical certification boards
(such as pediatric surgery).
(ii) The number of training
positions for residents described in
subparagraph (C), the number of such
positions recruited to fill, and the
number of such positions filled.
(iii) The types of training that
the hospital provided for residents
described in subparagraph (C) related
to the health care needs of different
populations, such as children who are
underserved for reasons of family
income or geographic location,
including rural and urban areas.
(iv) The changes in residency
training for residents described in
subparagraph (C) which the hospital has
made during such residency academic
year (except that the first report
submitted by the hospital under this
subparagraph shall be for such changes
since the first year in which the
hospital received payment under this
section), including--
(I) changes in curricula,
training experiences, and types
of training programs, and
benefits that have resulted
from such changes; and
(II) changes for purposes
of training the residents in
the measurement and improvement
of the quality and safety of
patient care.
(v) The numbers of residents
described in subparagraph (C) who
completed their residency training at
the end of such residency academic year
and care for children within the
borders of the service area of the
hospital or within the borders of the
State in which the hospital is located.
Such numbers shall be disaggregated
with respect to residents who completed
residencies in general pediatrics or
internal medicine/pediatrics,
subspecialty residencies, and dental
residencies.
(C) Residents.--The residents described in
this subparagraph are those who--
(i) are in full-time equivalent
resident training positions in any
training program sponsored by the
hospital; or
(ii) are in a training program
sponsored by an entity other than the
hospital, but who spend more than 75
percent of their training time at the
hospital.
(D) Report to congress.--Not later than the
end of fiscal year 2011, the Secretary, acting
through the Administrator of the Health
Resources and Services Administration, shall
submit a report to the Congress--
(i) summarizing the information
submitted in reports to the Secretary
under subparagraph (B);
(ii) describing the results of the
program carried out under this section;
and
(iii) making recommendations for
improvements to the program.
(c) Amount of Payment for Direct Graduate Medical
Education.--
(1) In general.--The amount determined under this
subsection for payments to a children's hospital for
direct graduate expenses relating to approved graduate
medical residency training programs for a fiscal year
is equal to the product of--
(A) the updated per resident amount for
direct graduate medical education, as
determined under paragraph (2); and
(B) the average number of full-time
equivalent residents in the hospital's graduate
approved medical residency training programs
(as determined under section 1886(h)(4) of the
Social Security Act during the fiscal year.
(2) Updated per resident amount for direct graduate
medical education.--The updated per resident amount for
direct graduate medical education for a hospital for a
fiscal year is an amount determined as follows:
(A) Determination of hospital single per
resident amount.--The Secretary shall compute
for each hospital operating an approved
graduate medical education program (regardless
of whether or not it is a children's hospital)
a single per resident amount equal to the
average (weighted by number of full-time
equivalent residents) of the primary care per
resident amount and the non-primary care per
resident amount computed under section
1886(h)(2) of the Social Security Act for cost
reporting periods ending during fiscal year
1997.
(B) Determination of wage and non-wage-
related proportion of the single per resident
amount.--The Secretary shall estimate the
average proportion of the single per resident
amounts computed under subparagraph (A) that is
attributable to wages and wage-related costs.
(C) Standardizing per resident amounts.--
The Secretary shall establish a standardized
per resident amount for each such hospital--
(i) by dividing the single per
resident amount computed under
subparagraph (A) into a wage-related
portion and a non-wage-related portion
by applying the proportion determined
under subparagraph (B);
(ii) by dividing the wage-related
portion by the factor applied under
section 1886(d)(3)(E) of the Social
Security Act for discharges occurring
during fiscal year 1999 for the
hospital's area; and
(iii) by adding the non-wage-
related portion to the amount computed
under clause (ii).
(D) Determination of national average.--The
Secretary shall compute a national average per
resident amount equal to the average of the
standardized per resident amounts computed
under subparagraph (C) for such hospitals, with
the amount for each hospital weighted by the
average number of full-time equivalent
residents at such hospital.
(E) Application to individual hospitals.--
The Secretary shall compute for each such
hospital that is a children's hospital a per
resident amount--
(i) by dividing the national
average per resident amount computed
under subparagraph (D) into a wage-
related portion and a non-wage-related
portion by applying the proportion
determined under subparagraph (B);
(ii) by multiplying the wage-
related portion by the factor applied
under section 1886(d)(3)(E) of the
Social Security Act for discharges
occurring during the preceding fiscal
year for the hospital's area; and
(iii) by adding the non-wage-
related portion to the amount computed
under clause (ii).
(F) Updating rate.--The Secretary shall
update such per resident amount for each such
children's hospital by the estimated percentage
increase in the consumer price index for all
urban consumers during the period beginning
October 1997 and ending with the midpoint of
the Federal fiscal year for which payments are
made.
(d) Amount of Payment for Indirect Medical Education.--
(1) In general.--The amount determined under this
subsection for payments to a children's hospital for
indirect expenses associated with the treatment of more
severely ill patients and the additional costs
associated with the teaching of residents for a fiscal
year is equal to an amount determined appropriate by
the Secretary.
(2) Factors.--In determining the amount under
paragraph (1), the Secretary shall--
(A) take into account variations in case
mix among children's hospitals and the ratio of
the number of full-time equivalent residents in
the hospitals' approved graduate medical
residency training programs to beds (but
excluding beds or bassinets assigned to healthy
newborn infants); and
(B) assure that the aggregate of the
payments for indirect expenses associated with
the treatment of more severely ill patients and
the additional costs related to the teaching of
residents under this section in a fiscal year
are equal to the amount appropriated for such
expenses for the fiscal year involved under
subsection (f)(2).
(e) Making of Payments.--
(1) Interim payments.--The Secretary shall
determine, before the beginning of each fiscal year
involved for which payments may be made for a hospital
under this section, the amounts of the payments for
direct graduate medical education and indirect medical
education for such fiscal year and shall (subject to
paragraph (2)) make the payments of such amounts in 12
equal interim installments during such period. Such
interim payments to each individual hospital shall be
based on the number of residents reported in the
hospital's most recently filed Medicare cost report
prior to the application date for the Federal fiscal
year for which the interim payment amounts are
established. In the case of a hospital that does not
report residents on a Medicare cost report, such
interim payments shall be based on the number of
residents trained during the hospital's most recently
completed Medicare cost report filing period.
(2) Withholding.--The Secretary shall withhold up
to 25 percent from each interim installment for direct
and indirect graduate medical education paid under
paragraph (1) as necessary to ensure a hospital will
not be overpaid on an interim basis.
(3) Reconciliation.--Prior to the end of each
fiscal year, the Secretary shall determine any changes
to the number of residents reported by a hospital in
the application of the hospital for the current fiscal
year to determine the final amount payable to the
hospital for the current fiscal year for both direct
expense and indirect expense amounts. Based on such
determination, the Secretary shall recoup any
overpayments made and pay any balance due to the extent
possible. The final amount so determined shall be
considered a final intermediary determination for the
purposes of section 1878 of the Social Security Act and
shall be subject to administrative and judicial review
under that section in the same manner as the amount of
payment under section 1186(d) of such Act is subject to
review under such section.
(f) Authorization of Appropriations.--
(1) Direct graduate medical education.--
(A) In general.--There are hereby
authorized to be appropriated, out of any money
in the Treasury not otherwise appropriated, for
payments under subsection (b)(1)(A)--
(i) for fiscal year 2000,
$90,000,000;
(ii) for fiscal year 2001,
$95,000,000;
(iii) for each of the fiscal years
2002 through 2005, such sums as may be
necessary; and
(iv) for each of fiscal years 2007
through 2011, $110,000,000.
(B) Carryover of excess.--The amounts
appropriated under subparagraph (A) for fiscal
year 2000 shall remain available for obligation
through the end of fiscal year 2001.
(2) Indirect medical education.--There are hereby
authorized to be appropriated, out of any money in the
Treasury not otherwise appropriated, for payments under
subsection (b)(1)(B)--
(A) for fiscal year 2000, $190,000,000;
(B) for fiscal year 2001, $190,000,000;
(C) for each of the fiscal years 2002
through 2005, such sums as may be necessary;
and
(D) for each of fiscal years 2007 through
2011, $220,000,000.
(g) Definitions.--In this section:
(1) Approved graduate medical residency training
program.--The term ``approved graduate medical
residency training program'' has the meaning given the
term ``approved medical residency training program'' in
section 1886(h)(5)(A) of the Social Security Act.
(2) Children's hospital.--The term ``children's
hospital'' means a hospital with a Medicare payment
agreement and which is excluded from the Medicare
inpatient prospective payment system pursuant to
section 1886(d)(1)(B)(iii) of the Social Security Act
and its accompanying regulations.
(3) Direct graduate medical education costs.--The
term ``direct graduate medical education costs'' has
the meaning given such term in section 1886(h)(5)(C) of
the Social Security Act.
Subpart X--Primary Dental Programs
SEC. 340F. [256F] DESIGNATED DENTAL HEALTH PROFESSIONAL SHORTAGE AREA.
In this subpart, the term ``designated dental health
professional shortage area'' means an area, population group,
or facility that is designated by the Secretary as a dental
health professional shortage area under section 332 or
designated by the applicable State as having a dental health
professional shortage.
SEC. 340G. [256G] GRANTS FOR INNOVATIVE PROGRAMS.
(a) Grant Program Authorized.--The Secretary, acting
through the Administrator of the Health Resources and Services
Administration, is authorized to award grants to States for the
purpose of helping States develop and implement innovative
programs to address the dental workforce needs of designated
dental health professional shortage areas in a manner that is
appropriate to the States' individual needs.
(b) State Activities.--A State receiving a grant under
subsection (a) may use funds received under the grant for--
(1) loan forgiveness and repayment programs for
dentists who--
(A) agree to practice in designated dental
health professional shortage areas;
(B) are dental school graduates who agree
to serve as public health dentists for the
Federal, State, or local government; and
(C) agree to--
(i) provide services to patients
regardless of such patients' ability to
pay; and
(ii) use a sliding payment scale
for patients who are unable to pay the
total cost of services;
(2) dental recruitment and retention efforts;
(3) grants and low-interest or no-interest loans to
help dentists who participate in the medicaid program
under title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) to establish or expand practices in
designated dental health professional shortage areas by
equipping dental offices or sharing in the overhead
costs of such practices;
(4) the establishment or expansion of dental
residency programs in coordination with accredited
dental training institutions in States without dental
schools;
(5) programs developed in consultation with State
and local dental societies to expand or establish oral
health services and facilities in designated dental
health professional shortage areas, including services
and facilities for children with special needs, such
as--
(A) the expansion or establishment of a
community-based dental facility, free-standing
dental clinic, consolidated health center
dental facility, school-linked dental facility,
or United States dental school-based facility;
(B) the establishment of a mobile or
portable dental clinic; and
(C) the establishment or expansion of
private dental services to enhance capacity
through additional equipment or additional
hours of operation;
(6) placement and support of dental students,
dental residents, and advanced dentistry trainees;
(7) continuing dental education, including
distance-based education;
(8) practice support through teledentistry
conducted in accordance with State laws;
(9) community-based prevention services such as
water fluoridation and dental sealant programs;
(10) coordination with local educational agencies
within the State to foster programs that promote
children going into oral health or science professions;
(11) the establishment of faculty recruitment
programs at accredited dental training institutions
whose mission includes community outreach and service
and that have a demonstrated record of serving
underserved States;
(12) the development of a State dental officer
position or the augmentation of a State dental office
to coordinate oral health and access issues in the
State; and
(13) any other activities determined to be
appropriate by the Secretary.
(c) Application.--
(1) In general.--Each State desiring a grant under
this section shall submit an application to the
Secretary at such time, in such manner, and containing
such information as the Secretary may reasonably
require.
(2) Assurances.--The application shall include
assurances that the State will meet the requirements of
subsection (d) and that the State possesses sufficient
infrastructure to manage the activities to be funded
through the grant and to evaluate and report on the
outcomes resulting from such activities.
(d) Matching Requirement.--The Secretary may not make a
grant to a State under this section unless that State agrees
that, with respect to the costs to be incurred by the State in
carrying out the activities for which the grant was awarded,
the State will provide non-Federal contributions in an amount
equal to not less than 40 percent of Federal funds provided
under the grant. The State may provide the contributions in
cash or in kind, fairly evaluated, including plant, equipment,
and services and may provide the contributions from State,
local, or private sources.
(e) Report.--Not later than 5 years after the date of
enactment of the Health Care Safety Net Amendments of 2002, the
Secretary shall prepare and submit to the appropriate
committees of Congress a report containing data relating to
whether grants provided under this section have increased
access to dental services in designated dental health
professional shortage areas.
(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $25,000,000 for
the 5-fiscal year period beginning with fiscal year 2008.
SEC. 340G-1. [256G-1] DEMONSTRATION PROGRAM.
(a) In General.--
(1) Authorization.--The Secretary is authorized to
award grants to 15 eligible entities to enable such
entities to establish a demonstration program to
establish training programs to train, or to employ,
alternative dental health care providers in order to
increase access to dental health care services in rural
and other underserved communities.
(2) Definition.--The term ``alternative dental
health care providers'' includes community dental
health coordinators, advance practice dental
hygienists, independent dental hygienists, supervised
dental hygienists, primary care physicians, dental
therapists, dental health aides, and any other health
professional that the Secretary determines appropriate.
(b) Timeframe.--The demonstration projects funded under
this section shall begin not later than 2 years after the date
of enactment of this section, and shall conclude not later than
7 years after such date of enactment.
(c) Eligible Entities.--To be eligible to receive a grant
under subsection (a), an entity shall--
(1) be--
(A) an institution of higher education,
including a community college;
(B) a public-private partnership;
(C) a federally qualified health center;
(D) an Indian Health Service facility or a
tribe or tribal organization (as such terms are
defined in section 4 of the Indian Self-
Determination and Education Assistance Act);
(E) a State or county public health clinic,
a health facility operated by an Indian tribe
or tribal organization, or urban Indian
organization providing dental services; or
(F) a public hospital or health system;
(2) be within a program accredited by the
Commission on Dental Accreditation or within a dental
education program in an accredited institution; and
(3) shall submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may require.
(d) Administrative Provisions.--
(1) Amount of grant.--Each grant under this section
shall be in an amount that is not less than $4,000,000
for the 5-year period during which the demonstration
project being conducted.
(2) Disbursement of funds.--
(A) Preliminary disbursements.--Beginning 1
year after the enactment of this section, the
Secretary may disperse to any entity receiving
a grant under this section not more than 20
percent of the total funding awarded to such
entity under such grant, for the purpose of
enabling the entity to plan the demonstration
project to be conducted under such grant.
(B) Subsequent disbursements.--The
remaining amount of grant funds not dispersed
under subparagraph (A) shall be dispersed such
that not less than 15 percent of such remaining
amount is dispersed each subsequent year.
(e) Compliance With State Requirements.--Each entity
receiving a grant under this section shall certify that it is
in compliance with all applicable State licensing requirements.
(f) Evaluation.--The Secretary shall contract with the
Director of the Institute of Medicine to conduct a study of the
demonstration programs conducted under this section that shall
provide analysis, based upon quantitative and qualitative data,
regarding access to dental health care in the United States.
(g) Clarification Regarding Dental Health Aide Program.--
Nothing in this section shall prohibit a dental health aide
training program approved by the Indian Health Service from
being eligible for a grant under this section.
(h) Authorization of Appropriations.--There is authorized
to be appropriated such sums as may be necessary to carry out
this section.
Subpart XI--Support of Graduate Medical Education in Qualified Teaching
Health Centers
SEC. 340H. [256H] PROGRAM OF PAYMENTS TO TEACHING HEALTH CENTERS THAT
OPERATE GRADUATE MEDICAL EDUCATION PROGRAMS.
(a) Payments.--Subject to subsection (h)(2), the Secretary
shall make payments under this section for direct expenses and
for indirect expenses to qualified teaching health centers that
are listed as sponsoring institutions by the relevant
accrediting body for expansion of existing or establishment of
new approved graduate medical residency training programs.
(b) Amount of Payments.--
(1) In general.--Subject to paragraph (2), the
amounts payable under this section to qualified
teaching health centers for an approved graduate
medical residency training program for a fiscal year
are each of the following amounts:
(A) Direct expense amount.--The amount
determined under subsection (c) for direct
expenses associated with sponsoring approved
graduate medical residency training programs.
(B) Indirect expense amount.--The amount
determined under subsection (d) for indirect
expenses associated with the additional costs
relating to teaching residents in such
programs.
(2) Capped amount.--
(A) In general.--The total of the payments
made to qualified teaching health centers under
paragraph (1)(A) or paragraph (1)(B) in a
fiscal year shall not exceed the amount of
funds appropriated under subsection (g) for
such payments for that fiscal year.
(B) Limitation.--The Secretary shall limit
the funding of full-time equivalent residents
in order to ensure the direct and indirect
payments as determined under subsection (c) and
(d) do not exceed the total amount of funds
appropriated in a fiscal year under subsection
(g).
(c) Amount of Payment for Direct Graduate Medical
Education.--
(1) In general.--The amount determined under this
subsection for payments to qualified teaching health
centers for direct graduate expenses relating to
approved graduate medical residency training programs
for a fiscal year is equal to the product of--
(A) the updated national per resident
amount for direct graduate medical education,
as determined under paragraph (2); and
(B) the average number of full-time
equivalent residents in the teaching health
center's graduate approved medical residency
training programs as determined under section
1886(h)(4) of the Social Security Act (without
regard to the limitation under subparagraph (F)
of such section) during the fiscal year.
(2) Updated national per resident amount for direct
graduate medical education.--The updated per resident
amount for direct graduate medical education for a
qualified teaching health center for a fiscal year is
an amount determined as follows:
(A) Determination of qualified teaching
health center per resident amount.--The
Secretary shall compute for each individual
qualified teaching health center a per resident
amount--
(i) by dividing the national
average per resident amount computed
under section 340E(c)(2)(D) into a
wage-related portion and a non-wage
related portion by applying the
proportion determined under
subparagraph (B);
(ii) by multiplying the wage-
related portion by the factor applied
under section 1886(d)(3)(E) of the
Social Security Act (but without
application of section 4410 of the
Balanced Budget Act of 1997 (42 U.S.C.
1395ww note)) during the preceding
fiscal year for the teaching health
center's area; and
(iii) by adding the non-wage-
related portion to the amount computed
under clause (ii).
(B) Updating rate.--The Secretary shall
update such per resident amount for each such
qualified teaching health center as determined
appropriate by the Secretary.
(d) Amount of Payment for Indirect Medical Education.--
(1) In general.--The amount determined under this
subsection for payments to qualified teaching health
centers for indirect expenses associated with the
additional costs of teaching residents for a fiscal
year is equal to an amount determined appropriate by
the Secretary.
(2) Factors.--In determining the amount under
paragraph (1), the Secretary shall--
(A) evaluate indirect training costs
relative to supporting a primary care residency
program in qualified teaching health centers;
and
(B) based on this evaluation, assure that
the aggregate of the payments for indirect
expenses under this section and the payments
for direct graduate medical education as
determined under subsection (c) in a fiscal
year do not exceed the amount appropriated for
such expenses as determined in subsection (g).
(3) Interim payment.--Before the Secretary makes a
payment under this subsection pursuant to a
determination of indirect expenses under paragraph (1),
the Secretary may provide to qualified teaching health
centers a payment, in addition to any payment made
under subsection (c), for expected indirect expenses
associated with the additional costs of teaching
residents for a fiscal year, based on an estimate by
the Secretary.
(e) Clarification Regarding Relationship to Other Payments
for Graduate Medical Education.--Payments under this section--
(1) shall be in addition to any payments--
(A) for the indirect costs of medical
education under section 1886(d)(5)(B) of the
Social Security Act;
(B) for direct graduate medical education
costs under section 1886(h) of such Act; and
(C) for direct costs of medical education
under section 1886(k) of such Act;
(2) shall not be taken into account in applying the
limitation on the number of total full-time equivalent
residents under subparagraphs (F) and (G) of section
1886(h)(4) of such Act and clauses (v), (vi)(I), and
(vi)(II) of section 1886(d)(5)(B) of such Act for the
portion of time that a resident rotates to a hospital;
and
(3) shall not include the time in which a resident
is counted toward full-time equivalency by a hospital
under paragraph (2) or under section 1886(d)(5)(B)(iv)
of the Social Security Act, section 1886(h)(4)(E) of
such Act, or section 340E of this Act.
(f) Reconciliation.--The Secretary shall determine any
changes to the number of residents reported by a hospital in
the application of the hospital for the current fiscal year to
determine the final amount payable to the hospital for the
current fiscal year for both direct expense and indirect
expense amounts. Based on such determination, the Secretary
shall recoup any overpayments made to pay any balance due to
the extent possible. The final amount so determined shall be
considered a final intermediary determination for the purposes
of section 1878 of the Social Security Act and shall be subject
to administrative and judicial review under that section in the
same manner as the amount of payment under section 1186(d) of
such Act is subject to review under such section.
(g) Funding.--To carry out this section, there are
appropriated such sums as may be necessary, not to exceed
$230,000,000, for the period of fiscal years 2011 through 2015.
(h) Annual Reporting Required.--
(1) Annual report.--The report required under this
paragraph for a qualified teaching health center for a
fiscal year is a report that includes (in a form and
manner specified by the Secretary) the following
information for the residency academic year completed
immediately prior to such fiscal year:
(A) The types of primary care resident
approved training programs that the qualified
teaching health center provided for residents.
(B) The number of approved training
positions for residents described in paragraph
(4).
(C) The number of residents described in
paragraph (4) who completed their residency
training at the end of such residency academic
year and care for vulnerable populations living
in underserved areas.
(D) Other information as deemed appropriate
by the Secretary.
(2) Audit authority; limitation on payment.--
(A) Audit authority.--The Secretary may
audit a qualified teaching health center to
ensure the accuracy and completeness of the
information submitted in a report under
paragraph (1).
(B) Limitation on payment.--A teaching
health center may only receive payment in a
cost reporting period for a number of such
resident positions that is greater than the
base level of primary care resident positions,
as determined by the Secretary. For purposes of
this subparagraph, the ``base level of primary
care residents'' for a teaching health center
is the level of such residents as of a base
period.
(3) Reduction in payment for failure to report.--
(A) In general.--The amount payable under
this section to a qualified teaching health
center for a fiscal year shall be reduced by at
least 25 percent if the Secretary determines
that--
(i) the qualified teaching health
center has failed to provide the
Secretary, as an addendum to the
qualified teaching health center's
application under this section for such
fiscal year, the report required under
paragraph (1) for the previous fiscal
year; or
(ii) such report fails to provide
complete and accurate information
required under any subparagraph of such
paragraph.
(B) Notice and opportunity to provide
accurate and missing information.--Before
imposing a reduction under subparagraph (A) on
the basis of a qualified teaching health
center's failure to provide complete and
accurate information described in subparagraph
(A)(ii), the Secretary shall provide notice to
the teaching health center of such failure and
the Secretary's intention to impose such
reduction and shall provide the teaching health
center with the opportunity to provide the
required information within the period of 30
days beginning on the date of such notice. If
the teaching health center provides such
information within such period, no reduction
shall be made under subparagraph (A) on the
basis of the previous failure to provide such
information.
(4) Residents.--The residents described in this
paragraph are those who are in part-time or full-time
equivalent resident training positions at a qualified
teaching health center in any approved graduate medical
residency training program.
(i) Regulations.--The Secretary shall promulgate
regulations to carry out this section.
(j) Definitions.--In this section:
(1) Approved graduate medical residency training
program.--The term ``approved graduate medical
residency training program'' means a residency or other
postgraduate medical training program--
(A) participation in which may be counted
toward certification in a specialty or
subspecialty and includes formal postgraduate
training programs in geriatric medicine
approved by the Secretary; and
(B) that meets criteria for accreditation
(as established by the Accreditation Council
for Graduate Medical Education, the American
Osteopathic Association, or the American Dental
Association).
(2) Primary care residency program.--The term
``primary care residency program'' has the meaning
given that term in section 749A.
(3) Qualified teaching health center.--The term
``qualified teaching health center'' has the meaning
given the term ``teaching health center'' in section
749A.
Subpart XI--Community-Based Collaborative Care Network Program
SEC. 340H. [256I] COMMUNITY-BASED COLLABORATIVE CARE NETWORK PROGRAM.
\1\
---------------------------------------------------------------------------
\1\ So in law. Sections 5508(c) and 10333 of Public Law 111-148
added a subpart XI including adding two sections designated as section
340H).
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(a) In General.--The Secretary may award grants to eligible
entities to support community-based collaborative care networks
that meet the requirements of subsection (b).
(b) Community-based Collaborative Care Networks.--
(1) Description.--A community-based collaborative
care network (referred to in this section as a
``network'') shall be a consortium of health care
providers with a joint governance structure (including
providers within a single entity) that provides
comprehensive coordinated and integrated health care
services (as defined by the Secretary) for low-income
populations.
(2) Required inclusion.--A network shall include
the following providers (unless such provider does not
exist within the community, declines or refuses to
participate, or places unreasonable conditions on their
participation):
(A) A hospital that meets the criteria in
section 1923(b)(1) of the Social Security Act;
and
(B) All Federally qualified health centers
(as defined in section 1861(aa) of the Social
Security Act located in the community.
(3) Priority.--In awarding grants, the Secretary
shall give priority to networks that include--
(A) the capability to provide the broadest
range of services to low-income individuals;
(B) the broadest range of providers that
currently serve a high volume of low-income
individuals; and
(C) a county or municipal department of
health.
(c) Application.--
(1) Application.--A network described in subsection
(b) shall submit an application to the Secretary.
(2) Renewal.--In subsequent years, based on the
performance of grantees, the Secretary may provide
renewal grants to prior year grant recipients.
(d) Use of Funds.--
(1) Use by grantees.--Grant funds may be used for
the following activities:
(A) Assist low-income individuals to--
(i) access and appropriately use
health services;
(ii) enroll in health coverage
programs; and
(iii) obtain a regular primary care
provider or a medical home.
(B) Provide case management and care
management.
(C) Perform health outreach using
neighborhood health workers or through other
means.
(D) Provide transportation.
(E) Expand capacity, including through
telehealth, after-hours services or urgent
care.
(F) Provide direct patient care services.
(2) Grant funds to hrsa grantees.--The Secretary
may limit the percent of grant funding that may be
spent on direct care services provided by grantees of
programs administered by the Health Resources and
Services Administration or impose other requirements on
such grantees deemed necessary.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2011 through 2015.
Part E--Narcotic Addicts and Other Drug Abusers \1\
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\1\ The probable intent of the Congress is that part E be repealed.
Section 3405(a) of Public Law 106-310 (114 Stat. 1221) provides as
follows: ``Part E of title III (42 U.S.C. 257 et seq.) is repealed.''
No Act is identified as the subject of the amendment, but the citation
given to the United States Code, section 257 of title 42, is the Code
section that codifies section 341 of this Act (the first section in
part E).
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care and treatment
Sec. 341. [257] (a) The Surgeon General is authorized to
provide for the confinement, care, protection, treatment, and
discipline of persons addicted to the use of habit-forming
narcotic drugs who are civilly committed to treatment under the
Narcotic Addict Rehabilitation Act of 1966, addicts and other
persons with drug abuse and drug dependence problems who
voluntarily submit themselves for treatment, and addicts
convicted of offenses against the United States, including
persons convicted by general courts-martial and consular
courts. Such care and treatment shall be provided at hospitals
of the Service especially equipped for the accommodation of
such patients or elsewhere where authorized under other
provisions of law, and shall be designed to rehabilitate such
persons, to restore them to health, and, where necessary, to
train them to be self-supporting and self-reliant; but nothing
in this section or in this part shall be construed to limit the
authority of the Surgeon General under other provisions of law
to provide for the conditional release of patients and for
aftercare under supervision. In carrying out this subsection,
the Secretary shall establish in each hospital and other
appropriate medical facility of the Service a treatment and
rehabilitation program for drug addicts and other persons with
drug abuse and drug dependence problems who are in the area
served by such hospital or other facility; except that the
requirement of this sentence shall not apply in the case of any
such hospital or other facility with respect to which the
Secretary determines that there is not sufficient need for such
a program in such hospital or other facility.
(b) Upon the admittance to, and departure from, a hospital
of the Service of a person who voluntarily submitted himself
for treatment pursuant to the provisions of this section, and
who at the time of his admittance to such hospital was a
resident of the District of Columbia, the Surgeon General shall
furnish to the Commissioners of the District of Columbia or
their designated agent, the name, address, and such other
pertinent information as may be useful in the rehabilitation to
society of such person.
(c) The Secretary may enter into agreements with the
Secretary of Veterans Affairs, the Secretary of Defense, and
the head of any other department or agency of the Government
under which agreements hospitals and other appropriate medical
facilities of the Service may be used in treatment and
rehabilitation programs provided by such department or agency
for drug addicts and other persons with drug abuse and other
drug dependence problems who are in areas served by such
hospitals or other facilities.
employment of addicts or other persons with drug abuse and drug
dependence problems
Sec. 342. [258] Narcotic addicts or other persons with drug
abuse and drug dependence problems in hospitals of the Service
designated for their care shall be employed in such manner and
under such conditions as the Surgeon General may direct. In
such hospitals the Surgeon General may, in his discretion,
establish industries, plants, factories, or shops for the
production and manufacture of articles, commodities, and
supplies for the United States Government. The Secretary of the
Treasury may require any Government department, establishment,
or other institution, for whom appropriations are made directly
or indirectly by the Congress of the United States, to purchase
at current market prices, as determined by him or his
authorized representative, such of the articles, commodities,
or supplies so produced or manufactured as meet their
specifications; and the Surgeon General shall provide for
payment to the inmates or their dependents of such pecuniary
earnings as he may deem proper. The Secretary shall establish a
working-capital fund for such industries, plants, factories,
and shops out of any funds appropriated for Public Health
Service hospitals at which addicts or other persons with drug
abuse and drug dependence problems are treated and cared for;
and such fund shall be available for the purchase, repair, or
replacement of machinery or equipment, for the purchase of raw
materials and supplies, for the purchase of uniforms and other
distinctive wearing apparel of employees in the performance of
their official duties, and for the employment of necessary
civilian officers and employees. The Surgeon General may
provide for the disposal of products of the industrial
activities conducted pursuant to this section, and the proceeds
of any sales thereof shall be covered into the Treasury of the
United States to the credit of the working-capital fund.
convicts
Sec. 343. [259] (a) The authority vested with the power to
designate the place of confinement of a prisoner shall transfer
to hospitals of the Service especially equipped for the
accommodation of addicts or other persons with drug abuse and
drug dependence problems, if accommodations are available, all
addicts or other persons with drug abuse and drug dependence
problems who have been or are hereafter sentenced to
confinement, or who are now or shall hereafter be confined, in
any penal, correctional, disciplinary, or reformatory
institution of the United States, including those addicts or
other persons with drug abuse and drug dependence problems
convicted of offenses against the United States who are
confined in State and Territorial prisons, penitentiaries, and
reformatories, except that no addict or other person with a
drug abuse or other drug dependence problem shall be
transferred to a hospital of the Service who, in the opinion of
the officer authorized to direct the transfer, is not a proper
subject for confinement in such an institution either because
of the nature of the crime he has committed or because of his
apparent incorrigibility. The authority vested with the power
to designate the place of confinement of a prisoner shall
transfer from a hospital of the Service to the institution from
which he was received, or to such other institution as may be
designated by the proper authority, any addict or other person
with a drug abuse or other drug dependence problem whose
presence at a hospital of the Service is detrimental to the
well-being of the hospital or who does not continue to be a
narcotic addict or other person with a drug abuse or other drug
dependence problem. All transfers of such prisoners to or from
a hospital of the Service shall be accompanied by necessary
attendants as directed by the officer in charge of such
hospital and the actual and necessary expenses incident to such
transfers shall be paid from the appropriation for the
maintenance of such Service hospital except to the extent that
other Federal agencies are authorized or required by law to pay
expenses incident to such transfers. When sentence is
pronounced against any person whom the prosecuting officer
believes to be an addict or other person with a drug abuse or
other drug dependence problem such officer shall report to the
authority vested with the power to designate the place of
confinement, the name of such person, the reasons for his
belief, all pertinent facts bearing on such addiction, drug
abuse, or drug dependence and the nature of the offense
committed. Whenever an alien addict or other person with a drug
abuse or other drug dependence problem transferred to a Service
hospital pursuant to this subsection is entitled to his
discharge but is subject to deportation, in lieu of being
returned to the penal institution from which he came he shall
be deported by the authority vested by law with power over
deportation.
(b) [Repealed.]
(c) Not later than one month prior to the expiration of the
sentence of any addict or other person with a drug abuse or
other drug dependence problem confined in a Service hospital,
he shall be examined by the Surgeon General or his authorized
representative. If the Surgeon General believes the person to
be discharged is still an addict or other person with a drug
abuse or other drug dependence problem and that he may by
further treatment in a Service hospital be cured of his
addiction, drug abuse, or drug dependence the addict or other
person with a drug abuse or other drug dependence problem shall
be informed, in accordance with regulations, of the
advisability of his submitting himself to further treatment.
The addict or other person with a drug abuse or other drug
dependence problem may then apply in writing to the Surgeon
General for further treatment in a Service hospital for a
period not exceeding the maximum length of time considered
necessary by the Surgeon General. Upon approval of the
application by the Surgeon General or his authorized agent, the
addict or other person with a drug abuse or other drug
dependence problem may be given such further treatment as is
necessary to cure him of his addiction, drug abuse, or drug
dependence.
(d) Every person convicted of an offense against the United
States, upon discharge, or upon release on parole or supervised
release from a hospital of the Service, shall be furnished with
the gratuities and transportation authorized by law to be
furnished to prisoners upon release from a penal, correctional,
disciplinary, or reformatory institution.
(e) Any court of the United States having the power to
suspend the imposition or execution of sentence and to place a
defendant on probation under any existing laws may impose as
one of the conditions of such probation that the defendant, if
an addict, or other person with a drug abuse or other drug
dependence problem shall submit himself for treatment at a
hospital of the Service especially equipped for the
accommodation of addicts or other persons with drug abuse and
drug dependence problems until discharged therefrom as cured
and that he shall be admitted thereto for such purpose. Upon
the discharge of any such probationer from a hospital of the
Service, he shall be furnished with the gratuities and
transportation authorized by law to be furnished to prisoners
upon release from a penal, correctional, disciplinary, or
reformatory institution. The actual and necessary expense
incident to transporting such probationer to such hospital and
to furnishing such transportation and gratuities shall be paid
from the appropriation for the maintenance of such hospital
except to the extent that other Federal agencies are authorized
or required by law to pay the cost of such transportation:
Provided, That where existing law vests a discretion in any
officer as to the place to which transportation shall be
furnished or as to the amount of clothing and gratuities to be
furnished, such discretion shall be exercised by the Surgeon
General with respect to addicts or other persons with drug
abuse and drug dependence problems discharged from hospitals of
the Service.
voluntary patients
Sec. 344. [260] (a) Any addict, or other person with a drug
abuse or other drug dependence problem whether or not he shall
have been convicted of an offense against the United States,
may apply to the Surgeon General for admission to a hospital of
the Service especially equipped for the accommodation of
addicts or other persons with drug abuse and drug dependence
problems.
(b) Any applicant shall be examined by the Surgeon General
who shall determine whether the applicant is an addict, or
other person with a drug abuse or other drug dependence problem
whether by treatment in a hospital of the Service he may
probably be cured of his addiction, drug abuse, or drug
dependence and the estimated length of time necessary to effect
his cure. The Surgeon General may, in his discretion, admit the
applicant to a Service hospital. No such addict or other person
with drug abuse or other drug dependence problem shall be
admitted unless he agrees to submit to treatment for the
maximum amount of time estimated by the Surgeon General to be
necessary to effect a cure, and unless suitable accommodations
are available after all eligible addicts or other persons with
drug abuse and drug dependence problems convicted of offenses
against the United States have been admitted. Any such addict
or other person with a drug abuse or other drug dependence
problem may be required to pay for his subsistence, care, and
treatment at rates fixed by the Surgeon General and amounts so
paid shall be covered into the Treasury of the United States to
the credit of the appropriation from which the expenditure for
his subsistence, care, and treatment was made. Appropriations
available for the care and treatment of addicts or other
persons with drug abuse and drug dependence problems admitted
to a hospital of the Service under this section shall be
available, subject to regulations, for paying the cost of
transportation to any place within the continental United
States, including subsistence allowance while traveling, for
any indigent addict or other person with a drug abuse or other
drug dependence problem who is discharged as cured.
(c) Any addict or other person with a drug abuse or other
drug dependence problem admitted for treatment under this
section, including any addict, or other person with a drug
abuse or other drug dependence problem not convicted of an
offense, who voluntarily submits himself for treatment, may be
confined in a hospital of the Service for a period not
exceeding the maximum amount of time estimated by the Surgeon
General as necessary to effect a cure of the addiction, drug
abuse, or drug dependence or until such time as he ceases to be
an addict or other person with a drug abuse or other drug
dependence problem.
(d) Any addict or other person with a drug abuse or other
drug dependence problem admitted for treatment under this
section shall not thereby forfeit or abridge any of his rights
as a citizen of the United States; nor shall such admission or
treatment be used against him in any proceeding in any court;
and the record of his voluntary commitment shall, except as
otherwise provided by this Act, be confidential and shall not
be divulged.
persons committed from district of columbia
Sec. 345. [260a] (a) The Surgeon General is authorized to
admit for care and treatment in any hospital of the Service
suitably equipped therefor, and thereafter to transfer between
hospitals of the Service in accordance with section 321(b), any
addict who is committed, under the provisions of the Act of
June 24, 1953 (Public Law 76, Eighty-third Congress) \1\, to
the Service or to a hospital thereof for care and treatment and
who the Surgeon General determines is a proper subject for care
and treatment. No such addict shall be admitted unless (1)
committed prior to July 1, 1958; and (2) at the time of
commitment, the number of persons in hospitals of the Service
who have been admitted pursuant to this subsection is less than
100; and (3) suitable accommodations are available after all
eligible addicts convicted of offenses against the United
States have been admitted.
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\1\ 67 Stat. 77. Codified to section 24-601 et seq., D.C. Code.
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(b) Any person admitted to a hospital of the Service
pursuant to subsection (a) shall be discharged therefrom (1)
upon order of the Superior Court of the District of Columbia,
or (2) when he is found by the Surgeon General to be cured and
rehabilitated. When any such person is so discharged, the
Surgeon General shall give notice thereof to the Superior Court
of the District of Columbia and shall deliver such person to
such court for such further action as such court may deem
necessary and proper under the provisions of the Act of June
24, 1953 (Public Law 76, Eighty-third Congress). \1\
(c) With respect to the detention, transfer, parole, or
discharge of any person committed to a hospital of the Service
in accordance with subsection (a), the Surgeon General and the
officer in charge of the hospital, in addition to authority
otherwise vested in them, shall have such authority as may be
conferred upon them, respectively, by the order of the
committing court.
(d) The cost of providing care and treatment for persons
admitted to a hospital of the Service pursuant to subsection
(a) shall be a charge upon the District of Columbia and shall
be paid by the District of Columbia to the Public Health
Service, either in advance or otherwise, as may be determined
by the Surgeon General. Such cost may be determined for each
addict or on the basis of rates established for all or
particular classes of patients, and shall include the cost of
transportation to and from facilities of the Public Health
Service. Moneys so paid to the Public Health Service shall be
covered into the Treasury of the United States as miscellaneous
receipts. Appropriations available for the care and treatment
of addicts admitted to a hospital of the Service under this
section shall be available, subject to regulations, for paying
the cost of transportation to the District of Columbia,
including subsistence allowance while traveling, for any such
addict who is discharged.
penalties
Sec. 346. [261] (a) Any person not authorized by law or by
the Surgeon General who introduces or attempts to introduce
into or upon the grounds of any hospital of the Service at
which addicts or other persons with drug abuse and drug
dependence problems are treated and cared for, any habit-
forming narcotic drug, or substance controlled under the
Controlled Substances Act, weapon, or any other contraband
article or thing, or any contraband letter or message intended
to be received by an inmate thereof, shall be guilty of a
felony and, upon conviction thereof, shall be punished by
imprisonment for not more than ten years.
(b) It shall be unlawful for any person properly committed
thereto to escape or attempt to escape from a hospital of the
Service at which addicts or other persons with drug abuse and
drug dependence problems are treated and cared for, and any
such person upon apprehension and conviction in a United States
court shall be punished by imprisonment for not more than five
years, such sentence to begin upon the expiration of the
sentence for which such person was originally confined.
(c) Any person who procures the escape of any person
admitted to a hospital of the Service at which addicts or other
persons with drug abuse and drug dependence problems are
treated and cared for, or who advises, connives at, aids, or
assists in such escape, or who conceals any such inmate after
such escape, shall be punished upon conviction in a United
States court by imprisonment in the penitentiary for not more
than three years.
release of patients
Sec. 347. [261a] For purposes of this Act, an individual
shall be deemed cured of his addiction, drug abuse, or drug
dependence, and rehabilitated if the Surgeon General determines
that he has received the maximum benefits of treatment and care
by the Service for his addiction, drug abuse, or drug
dependence, or if the Surgeon General determines that his
further treatment and care for such purpose would be
detrimental to the interests of the Service.
Part F--Licensing--Biological Products and Clinical Laboratories \1\
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\1\ Section 511(d) of Public Law 104-132 (110 Stat. 1284) relates
to the regulatory control of biological agents and includes a
requirement that the Secretary ``establish and maintain a list of each
biological agent that has the potential to pose a severe threat to
public health and safety''.
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Subpart 1--Biological Products
regulation of biological products \2\
Sec. 351. [262] (a)(1) No person shall introduce or deliver
for introduction into interstate commerce any biological
product unless--
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\2\ Section 123(f) of Public Law 105-115 (111 Stat. 2324) provides
as follows:
``(f) Special Rule.--The Secretary of Health and Human Services
shall take measures to minimize differences in the review and approval
of products required to have approved biologics license applications
under section 351 of the Public Health Service Act (42 U.S.C. 262) and
products required to have approved new drug applications under section
505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)(1)).''.
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(A) a biologics license under this subsection or
subsection (k) is in effect for the biological product;
and
(B) each package of the biological product is
plainly marked with--
(i) the proper name of the biological
product contained in the package;
(ii) the name, address, and applicable
license number of the manufacturer of the
biological product; and
(iii) the expiration date of the biological
product.
(2)(A) The Secretary shall establish, by regulation,
requirements for the approval, suspension, and revocation of
biologics licenses.
(B) Pediatric studies.--A person that
submits an application for a license under this
paragraph shall submit to the Secretary as part
of the application any assessments required
under section 505B of the Federal Food, Drug,
and Cosmetic Act.
(C) The Secretary shall approve a biologics license
application--
(i) on the basis of a demonstration that--
(I) the biological product that is the
subject of the application is safe, pure, and
potent; and
(II) the facility in which the biological
product is manufactured, processed, packed, or
held meets standards designed to assure that
the biological product continues to be safe,
pure, and potent; and
(ii) if the applicant (or other appropriate person)
consents to the inspection of the facility that is the
subject of the application, in accordance with
subsection (c).
(D) Postmarket Studies and Clinical Trials; Labeling; Risk
Evaluation and Mitigation Strategy.--A person that submits an
application for a license under this paragraph is subject to
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug,
and Cosmetic Act.
(3) The Secretary shall prescribe requirements under which
a biological product undergoing investigation shall be exempt
from the requirements of paragraph (1).
(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark
on the package or container of the biological product so as to
falsify the label or mark.
(c) Any officer, agent, or employee of the Department of
Health and Human Services, authorized by the Secretary for the
purpose, may during all reasonable hours enter and inspect any
establishment for the propagation or manufacture and
preparation of any biological product.
(d)(1) Upon a determination that a batch, lot, or other
quantity of a product licensed under this section presents an
imminent or substantial hazard to the public health, the
Secretary shall issue an order immediately ordering the recall
of such batch, lot, or other quantity of such product. An order
under this paragraph shall be issued in accordance with section
554 of title 5, United States Code.
(2) Any violation of paragraph (1) shall subject the
violator to a civil penalty of up to $100,000 per day of
violation. The amount of a civil penalty under this paragraph
shall, effective December 1 of each year beginning 1 year after
the effective date of this paragraph, be increased by the
percent change in the Consumer Price Index for the base quarter
of such year over the Consumer Price Index for the base quarter
of the preceding year, adjusted to the nearest \1/10\ of 1
percent. For purposes of this paragraph, the term ``base
quarter'', as used with respect to a year, means the calendar
quarter ending on September 30 of such year and the price index
for a base quarter is the arithmetical mean of such index for
the 3 months comprising such quarter.
(e) No person shall interfere with any officer, agent, or
employee of the Service in the performance of any duty imposed
upon him by this section or by regulations made by authority
thereof.
(f) Any person who shall violate, or aid or abet in
violating, any of the provisions of this section shall be
punished upon conviction by a fine not exceeding $500 or by
imprisonment not exceeding one year, or by both such fine and
imprisonment, in the discretion of the court.
(g) Nothing contained in this Act shall be construed as in
any way affecting, modifying, repealing, or superseding the
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C.,
1940 edition, title 21, ch. 9). \1\
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\1\ Codification remains chapter 9 of title 21, United States Code
(Sec. 301 et seq.).
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(h) \2\ A partially processed biological product which--
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\2\ Section 2102(d)(2) of title II of Public Law 104-134 (110 Stat.
1321-319) amended certain provisions in subsection (h). Subsequently,
section 2104 of such Public Law (110 Stat. 1321-320) amended subsection
(h) in its entirety. The above reflects only the latter amendment.
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(1) is not in a form applicable to the prevention,
treatment, or cure of diseases or injuries of man;
(2) is not intended for sale in the United States;
and
(3) is intended for further manufacture into final
dosage form outside the United States,
shall be subject to no restriction on the export of the product
under this Act or the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et. seq.) if the product is manufactured, processed,
packaged, and held in conformity with current good
manufacturing practice requirements or meets international
manufacturing standards as certified by an international
standards organization recognized by the Secretary and meets
the requirements of section 801(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
(i) In this section:
(1) The term ``biological product'' means a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product,
protein (except any chemically synthesized
polypeptide), or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent
organic arsenic compound), applicable to the
prevention, treatment, or cure of a disease or
condition of human beings.
(2) The term ``biosimilar'' or ``biosimilarity'',
in reference to a biological product that is the
subject of an application under subsection (k), means--
(A) that the biological product is highly
similar to the reference product
notwithstanding minor differences in clinically
inactive components; and
(B) there are no clinically meaningful
differences between the biological product and
the reference product in terms of the safety,
purity, and potency of the product.
(3) The term ``interchangeable'' or
``interchangeability'', in reference to a biological
product that is shown to meet the standards described
in subsection (k)(4), means that the biological product
may be substituted for the reference product without
the intervention of the health care provider who
prescribed the reference product.
(4) The term ``reference product'' means the single
biological product licensed under subsection (a)
against which a biological product is evaluated in an
application submitted under subsection (k).
(j) The Federal Food, Drug, and Cosmetic Act, including the
requirements under sections 505(o), 505(p), and 505-1 of such
Act, applies to a biological product subject to regulation
under this section, except that a product for which a license
has been approved under subsection (a) shall not be required to
have an approved application under section 505 of such Act.
(k) Licensure of Biological Products as Biosimilar or
Interchangeable.--
(1) In general.--Any person may submit an
application for licensure of a biological product under
this subsection.
(2) Content.--
(A) In general.--
(i) Required information.--An
application submitted under this
subsection shall include information
demonstrating that--
(I) the biological product
is biosimilar to a reference
product based upon data derived
from--
(aa) analytical
studies that
demonstrate that the
biological product is
highly similar to the
reference product
notwithstanding minor
differences in
clinically inactive
components;
(bb) animal studies
(including the
assessment of
toxicity); and
(cc) a clinical
study or studies
(including the
assessment of
immunogenicity and
pharmacokinetics or
pharmacodynamics) that
are sufficient to
demonstrate safety,
purity, and potency in
1 or more appropriate
conditions of use for
which the reference
product is licensed and
intended to be used and
for which licensure is
sought for the
biological product;
(II) the biological product
and reference product utilize
the same mechanism or
mechanisms of action for the
condition or conditions of use
prescribed, recommended, or
suggested in the proposed
labeling, but only to the
extent the mechanism or
mechanisms of action are known
for the reference product;
(III) the condition or
conditions of use prescribed,
recommended, or suggested in
the labeling proposed for the
biological product have been
previously approved for the
reference product;
(IV) the route of
administration, the dosage
form, and the strength of the
biological product are the same
as those of the reference
product; and
(V) the facility in which
the biological product is
manufactured, processed,
packed, or held meets standards
designed to assure that the
biological product continues to
be safe, pure, and potent.
(ii) Determination by secretary.--
The Secretary may determine, in the
Secretary's discretion, that an element
described in clause (i)(I) is
unnecessary in an application submitted
under this subsection.
(iii) Additional information.--An
application submitted under this
subsection--
(I) shall include publicly-
available information regarding
the Secretary's previous
determination that the
reference product is safe,
pure, and potent; and
(II) may include any
additional information in
support of the application,
including publicly-available
information with respect to the
reference product or another
biological product.
(B) Interchangeability.--An application (or
a supplement to an application) submitted under
this subsection may include information
demonstrating that the biological product meets
the standards described in paragraph (4).
(3) Evaluation by secretary.--Upon review of an
application (or a supplement to an application)
submitted under this subsection, the Secretary shall
license the biological product under this subsection
if--
(A) the Secretary determines that the
information submitted in the application (or
the supplement) is sufficient to show that the
biological product--
(i) is biosimilar to the reference
product; or
(ii) meets the standards described
in paragraph (4), and therefore is
interchangeable with the reference
product; and
(B) the applicant (or other appropriate
person) consents to the inspection of the
facility that is the subject of the
application, in accordance with subsection (c).
(4) Safety standards for determining
interchangeability.--Upon review of an application
submitted under this subsection or any supplement to
such application, the Secretary shall determine the
biological product to be interchangeable with the
reference product if the Secretary determines that the
information submitted in the application (or a
supplement to such application) is sufficient to show
that--
(A) the biological product--
(i) is biosimilar to the reference
product; and
(ii) can be expected to produce the
same clinical result as the reference
product in any given patient; and
(B) for a biological product that is
administered more than once to an individual,
the risk in terms of safety or diminished
efficacy of alternating or switching between
use of the biological product and the reference
product is not greater than the risk of using
the reference product without such alternation
or switch.
(5) General rules.--
(A) One reference product per
application.--A biological product, in an
application submitted under this subsection,
may not be evaluated against more than 1
reference product.
(B) Review.--An application submitted under
this subsection shall be reviewed by the
division within the Food and Drug
Administration that is responsible for the
review and approval of the application under
which the reference product is licensed.
(C) Risk evaluation and mitigation
strategies.--The authority of the Secretary
with respect to risk evaluation and mitigation
strategies under the Federal Food, Drug, and
Cosmetic Act shall apply to biological products
licensed under this subsection in the same
manner as such authority applies to biological
products licensed under subsection (a).
(6) Exclusivity for first interchangeable
biological product.--Upon review of an application
submitted under this subsection relying on the same
reference product for which a prior biological product
has received a determination of interchangeability for
any condition of use, the Secretary shall not make a
determination under paragraph (4) that the second or
subsequent biological product is interchangeable for
any condition of use until the earlier of--
(A) 1 year after the first commercial
marketing of the first interchangeable
biosimilar biological product to be approved as
interchangeable for that reference product;
(B) 18 months after--
(i) a final court decision on all
patents in suit in an action instituted
under subsection (l)(6) against the
applicant that submitted the
application for the first approved
interchangeable biosimilar biological
product; or
(ii) the dismissal with or without
prejudice of an action instituted under
subsection (l)(6) against the applicant
that submitted the application for the
first approved interchangeable
biosimilar biological product; or
(C)(i) 42 months after approval of the
first interchangeable biosimilar biological
product if the applicant that submitted such
application has been sued under subsection
(l)(6) and such litigation is still ongoing
within such 42-month period; or
(ii) 18 months after approval of the first
interchangeable biosimilar biological product
if the applicant that submitted such
application has not been sued under subsection
(l)(6).
For purposes of this paragraph, the term ``final court
decision'' means a final decision of a court from which
no appeal (other than a petition to the United States
Supreme Court for a writ of certiorari) has been or can
be taken.
(7) Exclusivity for reference product.--
(A) Effective date of biosimilar
application approval.--Approval of an
application under this subsection may not be
made effective by the Secretary until the date
that is 12 years after the date on which the
reference product was first licensed under
subsection (a).
(B) Filing period.--An application under
this subsection may not be submitted to the
Secretary until the date that is 4 years after
the date on which the reference product was
first licensed under subsection (a).
(C) First licensure.--Subparagraphs (A) and
(B) shall not apply to a license for or
approval of--
(i) a supplement for the biological
product that is the reference product;
or
(ii) a subsequent application filed
by the same sponsor or manufacturer of
the biological product that is the
reference product (or a licensor,
predecessor in interest, or other
related entity) for--
(I) a change (not including
a modification to the structure
of the biological product) that
results in a new indication,
route of administration, dosing
schedule, dosage form, delivery
system, delivery device, or
strength; or
(II) a modification to the
structure of the biological
product that does not result in
a change in safety, purity, or
potency.
(8) Guidance documents.--
(A) In general.--The Secretary may, after
opportunity for public comment, issue guidance
in accordance, except as provided in
subparagraph (B)(i), with section 701(h) of the
Federal Food, Drug, and Cosmetic Act with
respect to the licensure of a biological
product under this subsection. Any such
guidance may be general or specific.
(B) Public comment.--
(i) In general.--The Secretary
shall provide the public an opportunity
to comment on any proposed guidance
issued under subparagraph (A) before
issuing final guidance.
(ii) Input regarding most valuable
guidance.--The Secretary shall
establish a process through which the
public may provide the Secretary with
input regarding priorities for issuing
guidance.
(C) No requirement for application
consideration.--The issuance (or non-issuance)
of guidance under subparagraph (A) shall not
preclude the review of, or action on, an
application submitted under this subsection.
(D) Requirement for product class-specific
guidance.--If the Secretary issues product
class-specific guidance under subparagraph (A),
such guidance shall include a description of--
(i) the criteria that the Secretary
will use to determine whether a
biological product is highly similar to
a reference product in such product
class; and
(ii) the criteria, if available,
that the Secretary will use to
determine whether a biological product
meets the standards described in
paragraph (4).
(E) Certain product classes.--
(i) Guidance.--The Secretary may
indicate in a guidance document that
the science and experience, as of the
date of such guidance, with respect to
a product or product class (not
including any recombinant protein) does
not allow approval of an application
for a license as provided under this
subsection for such product or product
class.
(ii) Modification or reversal.--The
Secretary may issue a subsequent
guidance document under subparagraph
(A) to modify or reverse a guidance
document under clause (i).
(iii) No effect on ability to deny
license.--Clause (i) shall not be
construed to require the Secretary to
approve a product with respect to which
the Secretary has not indicated in a
guidance document that the science and
experience, as described in clause (i),
does not allow approval of such an
application.
(l) Patents.--
(1) Confidential access to subsection (k)
application.--
(A) Application of paragraph.--Unless
otherwise agreed to by a person that submits an
application under subsection (k) (referred to
in this subsection as the ``subsection (k)
applicant'') and the sponsor of the application
for the reference product (referred to in this
subsection as the ``reference product
sponsor''), the provisions of this paragraph
shall apply to the exchange of information
described in this subsection.
(B) In general.--
(i) Provision of confidential
information.--When a subsection (k)
applicant submits an application under
subsection (k), such applicant shall
provide to the persons described in
clause (ii), subject to the terms of
this paragraph, confidential access to
the information required to be produced
pursuant to paragraph (2) and any other
information that the subsection (k)
applicant determines, in its sole
discretion, to be appropriate (referred
to in this subsection as the
``confidential information'').
(ii) Recipients of information.--
The persons described in this clause
are the following:
(I) Outside counsel.--One
or more attorneys designated by
the reference product sponsor
who are employees of an entity
other than the reference
product sponsor (referred to in
this paragraph as the ``outside
counsel''), provided that such
attorneys do not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(II) In-house counsel.--One
attorney that represents the
reference product sponsor who
is an employee of the reference
product sponsor, provided that
such attorney does not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(iii) Patent owner access.--A
representative of the owner of a patent
exclusively licensed to a reference
product sponsor with respect to the
reference product and who has retained
a right to assert the patent or
participate in litigation concerning
the patent may be provided the
confidential information, provided that
the representative informs the
reference product sponsor and the
subsection (k) applicant of his or her
agreement to be subject to the
confidentiality provisions set forth in
this paragraph, including those under
clause (ii).
(C) Limitation on disclosure.--No person
that receives confidential information pursuant
to subparagraph (B) shall disclose any
confidential information to any other person or
entity, including the reference product sponsor
employees, outside scientific consultants, or
other outside counsel retained by the reference
product sponsor, without the prior written
consent of the subsection (k) applicant, which
shall not be unreasonably withheld.
(D) Use of confidential information.--
Confidential information shall be used for the
sole and exclusive purpose of determining, with
respect to each patent assigned to or
exclusively licensed by the reference product
sponsor, whether a claim of patent infringement
could reasonably be asserted if the subsection
(k) applicant engaged in the manufacture, use,
offering for sale, sale, or importation into
the United States of the biological product
that is the subject of the application under
subsection (k).
(E) Ownership of confidential
information.--The confidential information
disclosed under this paragraph is, and shall
remain, the property of the subsection (k)
applicant. By providing the confidential
information pursuant to this paragraph, the
subsection (k) applicant does not provide the
reference product sponsor or the outside
counsel any interest in or license to use the
confidential information, for purposes other
than those specified in subparagraph (D).
(F) Effect of infringement action.--In the
event that the reference product sponsor files
a patent infringement suit, the use of
confidential information shall continue to be
governed by the terms of this paragraph until
such time as a court enters a protective order
regarding the information. Upon entry of such
order, the subsection (k) applicant may
redesignate confidential information in
accordance with the terms of that order. No
confidential information shall be included in
any publicly-available complaint or other
pleading. In the event that the reference
product sponsor does not file an infringement
action by the date specified in paragraph (6),
the reference product sponsor shall return or
destroy all confidential information received
under this paragraph, provided that if the
reference product sponsor opts to destroy such
information, it will confirm destruction in
writing to the subsection (k) applicant.
(G) Rule of construction.--Nothing in this
paragraph shall be construed--
(i) as an admission by the
subsection (k) applicant regarding the
validity, enforceability, or
infringement of any patent; or
(ii) as an agreement or admission
by the subsection (k) applicant with
respect to the competency, relevance,
or materiality of any confidential
information.
(H) Effect of violation.--The disclosure of
any confidential information in violation of
this paragraph shall be deemed to cause the
subsection (k) applicant to suffer irreparable
harm for which there is no adequate legal
remedy and the court shall consider immediate
injunctive relief to be an appropriate and
necessary remedy for any violation or
threatened violation of this paragraph.
(2) Subsection (k) application information.--Not
later than 20 days after the Secretary notifies the
subsection (k) applicant that the application has been
accepted for review, the subsection (k) applicant--
(A) shall provide to the reference product
sponsor a copy of the application submitted to
the Secretary under subsection (k), and such
other information that describes the process or
processes used to manufacture the biological
product that is the subject of such
application; and
(B) may provide to the reference product
sponsor additional information requested by or
on behalf of the reference product sponsor.
(3) List and description of patents.--
(A) List by reference product sponsor.--Not
later than 60 days after the receipt of the
application and information under paragraph
(2), the reference product sponsor shall
provide to the subsection (k) applicant--
(i) a list of patents for which the
reference product sponsor believes a
claim of patent infringement could
reasonably be asserted by the reference
product sponsor, or by a patent owner
that has granted an exclusive license
to the reference product sponsor with
respect to the reference product, if a
person not licensed by the reference
product sponsor engaged in the making,
using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject
of the subsection (k) application; and
(ii) an identification of the
patents on such list that the reference
product sponsor would be prepared to
license to the subsection (k)
applicant.
(B) List and description by subsection (k)
applicant.--Not later than 60 days after
receipt of the list under subparagraph (A), the
subsection (k) applicant--
(i) may provide to the reference
product sponsor a list of patents to
which the subsection (k) applicant
believes a claim of patent infringement
could reasonably be asserted by the
reference product sponsor if a person
not licensed by the reference product
sponsor engaged in the making, using,
offering to sell, selling, or importing
into the United States of the
biological product that is the subject
of the subsection (k) application;
(ii) shall provide to the reference
product sponsor, with respect to each
patent listed by the reference product
sponsor under subparagraph (A) or
listed by the subsection (k) applicant
under clause (i)--
(I) a detailed statement
that describes, on a claim by
claim basis, the factual and
legal basis of the opinion of
the subsection (k) applicant
that such patent is invalid,
unenforceable, or will not be
infringed by the commercial
marketing of the biological
product that is the subject of
the subsection (k) application;
or
(II) a statement that the
subsection (k) applicant does
not intend to begin commercial
marketing of the biological
product before the date that
such patent expires; and
(iii) shall provide to the
reference product sponsor a response
regarding each patent identified by the
reference product sponsor under
subparagraph (A)(ii).
(C) Description by reference product
sponsor.--Not later than 60 days after receipt
of the list and statement under subparagraph
(B), the reference product sponsor shall
provide to the subsection (k) applicant a
detailed statement that describes, with respect
to each patent described in subparagraph
(B)(ii)(I), on a claim by claim basis, the
factual and legal basis of the opinion of the
reference product sponsor that such patent will
be infringed by the commercial marketing of the
biological product that is the subject of the
subsection (k) application and a response to
the statement concerning validity and
enforceability provided under subparagraph
(B)(ii)(I).
(4) Patent resolution negotiations.--
(A) In general.--After receipt by the
subsection (k) applicant of the statement under
paragraph (3)(C), the reference product sponsor
and the subsection (k) applicant shall engage
in good faith negotiations to agree on which,
if any, patents listed under paragraph (3) by
the subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6).
(B) Failure to reach agreement.--If, within
15 days of beginning negotiations under
subparagraph (A), the subsection (k) applicant
and the reference product sponsor fail to agree
on a final and complete list of which, if any,
patents listed under paragraph (3) by the
subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6), the provisions of paragraph (5) shall
apply to the parties.
(5) Patent resolution if no agreement.--
(A) Number of patents.--The subsection (k)
applicant shall notify the reference product
sponsor of the number of patents that such
applicant will provide to the reference product
sponsor under subparagraph (B)(i)(I).
(B) Exchange of patent lists.--
(i) In general.--On a date agreed
to by the subsection (k) applicant and
the reference product sponsor, but in
no case later than 5 days after the
subsection (k) applicant notifies the
reference product sponsor under
subparagraph (A), the subsection (k)
applicant and the reference product
sponsor shall simultaneously exchange--
(I) the list of patents
that the subsection (k)
applicant believes should be
the subject of an action for
patent infringement under
paragraph (6); and
(II) the list of patents,
in accordance with clause (ii),
that the reference product
sponsor believes should be the
subject of an action for patent
infringement under paragraph
(6).
(ii) Number of patents listed by
reference product sponsor.--
(I) In general.--Subject to
subclause (II), the number of
patents listed by the reference
product sponsor under clause
(i)(II) may not exceed the
number of patents listed by the
subsection (k) applicant under
clause (i)(I).
(II) Exception.--If a
subsection (k) applicant does
not list any patent under
clause (i)(I), the reference
product sponsor may list 1
patent under clause (i)(II).
(6) Immediate patent infringement action.--
(A) Action if agreement on patent list.--If
the subsection (k) applicant and the reference
product sponsor agree on patents as described
in paragraph (4), not later than 30 days after
such agreement, the reference product sponsor
shall bring an action for patent infringement
with respect to each such patent.
(B) Action if no agreement on patent
list.--If the provisions of paragraph (5) apply
to the parties as described in paragraph
(4)(B), not later than 30 days after the
exchange of lists under paragraph (5)(B), the
reference product sponsor shall bring an action
for patent infringement with respect to each
patent that is included on such lists.
(C) Notification and publication of
complaint.--
(i) Notification to secretary.--Not
later than 30 days after a complaint is
served to a subsection (k) applicant in
an action for patent infringement
described under this paragraph, the
subsection (k) applicant shall provide
the Secretary with notice and a copy of
such complaint.
(ii) Publication by secretary.--The
Secretary shall publish in the Federal
Register notice of a complaint received
under clause (i).
(7) Newly issued or licensed patents.--In the case
of a patent that--
(A) is issued to, or exclusively licensed
by, the reference product sponsor after the
date that the reference product sponsor
provided the list to the subsection (k)
applicant under paragraph (3)(A); and
(B) the reference product sponsor
reasonably believes that, due to the issuance
of such patent, a claim of patent infringement
could reasonably be asserted by the reference
product sponsor if a person not licensed by the
reference product sponsor engaged in the
making, using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject of the
subsection (k) application,
not later than 30 days after such issuance or
licensing, the reference product sponsor shall provide
to the subsection (k) applicant a supplement to the
list provided by the reference product sponsor under
paragraph (3)(A) that includes such patent, not later
than 30 days after such supplement is provided, the
subsection (k) applicant shall provide a statement to
the reference product sponsor in accordance with
paragraph (3)(B), and such patent shall be subject to
paragraph (8).
(8) Notice of commercial marketing and preliminary
injunction.--
(A) Notice of commercial marketing.--The
subsection (k) applicant shall provide notice
to the reference product sponsor not later than
180 days before the date of the first
commercial marketing of the biological product
licensed under subsection (k).
(B) Preliminary injunction.--After
receiving the notice under subparagraph (A) and
before such date of the first commercial
marketing of such biological product, the
reference product sponsor may seek a
preliminary injunction prohibiting the
subsection (k) applicant from engaging in the
commercial manufacture or sale of such
biological product until the court decides the
issue of patent validity, enforcement, and
infringement with respect to any patent that
is--
(i) included in the list provided
by the reference product sponsor under
paragraph (3)(A) or in the list
provided by the subsection (k)
applicant under paragraph (3)(B); and
(ii) not included, as applicable,
on--
(I) the list of patents
described in paragraph (4); or
(II) the lists of patents
described in paragraph (5)(B).
(C) Reasonable cooperation.--If the
reference product sponsor has sought a
preliminary injunction under subparagraph (B),
the reference product sponsor and the
subsection (k) applicant shall reasonably
cooperate to expedite such further discovery as
is needed in connection with the preliminary
injunction motion.
(9) Limitation on declaratory judgment action.--
(A) Subsection (k) application provided.--
If a subsection (k) applicant provides the
application and information required under
paragraph (2)(A), neither the reference product
sponsor nor the subsection (k) applicant may,
prior to the date notice is received under
paragraph (8)(A), bring any action under
section 2201 of title 28, United States Code,
for a declaration of infringement, validity, or
enforceability of any patent that is described
in clauses (i) and (ii) of paragraph (8)(B).
(B) Subsequent failure to act by subsection
(k) applicant.--If a subsection (k) applicant
fails to complete an action required of the
subsection (k) applicant under paragraph
(3)(B)(ii), paragraph (5), paragraph (6)(C)(i),
paragraph (7), or paragraph (8)(A), the
reference product sponsor, but not the
subsection (k) applicant, may bring an action
under section 2201 of title 28, United States
Code, for a declaration of infringement,
validity, or enforceability of any patent
included in the list described in paragraph
(3)(A), including as provided under paragraph
(7).
(C) Subsection (k) application not
provided.--If a subsection (k) applicant fails
to provide the application and information
required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k)
applicant, may bring an action under section
2201 of title 28, United States Code, for a
declaration of infringement, validity, or
enforceability of any patent that claims the
biological product or a use of the biological
product.
(m) Pediatric Studies.--
(1) Application of certain provisions.--The
provisions of subsections (a), (d), (e), (f), (i), (j),
(k), (l), (p), and (q) of section 505A of the Federal
Food, Drug, and Cosmetic Act shall apply with respect
to the extension of a period under paragraphs (2) and
(3) to the same extent and in the same manner as such
provisions apply with respect to the extension of a
period under subsection (b) or (c) of section 505A of
the Federal Food, Drug, and Cosmetic Act.
(2) Market exclusivity for new biological
products.--If, prior to approval of an application that
is submitted under subsection (a), the Secretary
determines that information relating to the use of a
new biological product in the pediatric population may
produce health benefits in that population, the
Secretary makes a written request for pediatric studies
(which shall include a timeframe for completing such
studies), the applicant agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(3) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(3) Market exclusivity for already-marketed
biological products.--If the Secretary determines that
information relating to the use of a licensed
biological product in the pediatric population may
produce health benefits in that population and makes a
written request to the holder of an approved
application under subsection (a) for pediatric studies
(which shall include a timeframe for completing such
studies), the holder agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(3) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(4) Exception.--The Secretary shall not extend a
period referred to in paragraph (2)(A), (2)(B), (3)(A),
or (3)(B) if the determination under section 505A(d)(3)
is made later than 9 months prior to the expiration of
such period.
SEC. 351A. [262A] ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND
TOXINS. \3\
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\3\ A program is carried out by the Secretary of Agriculture with
respect to each biological agent and each toxin that the Secretary
determines has the potential to pose a severe threat to animal or plant
health, or to animal or plant products. Such program has requirements
and authorities similar to those established in section 351A above. See
subtitle B of title II of Public Law 107-188 (section 211 et seq.; 116
Stat. 647). Subtitle C of such title (section 221 et seq.; 116 Stat.
657) relates to interagency coordination of the two programs.
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(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary shall by
regulation establish and maintain a list of
each biological agent and each toxin that has
the potential to pose a severe threat to public
health and safety.
(B) Criteria.--In determining whether to
include an agent or toxin on the list under
subparagraph (A), the Secretary shall--
(i) consider--
(I) the effect on human
health of exposure to the agent
or toxin;
(II) the degree of
contagiousness of the agent or
toxin and the methods by which
the agent or toxin is
transferred to humans;
(III) the availability and
effectiveness of
pharmacotherapies and
immunizations to treat and
prevent any illness resulting
from infection by the agent or
toxin; and
(IV) any other criteria,
including the needs of children
and other vulnerable
populations, that the Secretary
considers appropriate; and
(ii) consult with appropriate
Federal departments and agencies and
with scientific experts representing
appropriate professional groups,
including groups with pediatric
expertise.
(2) Biennial review.--The Secretary shall review
and republish the list under paragraph (1) biennially,
or more often as needed, and shall by regulation revise
the list as necessary in accordance with such
paragraph.
(b) Regulation of Transfers of Listed Agents and Toxins.--
The Secretary shall by regulation provide for--
(1) the establishment and enforcement of safety
procedures for the transfer of listed agents and
toxins, including measures to ensure--
(A) proper training and appropriate skills
to handle such agents and toxins; and
(B) proper laboratory facilities to contain
and dispose of such agents and toxins;
(2) the establishment and enforcement of safeguard
and security measures to prevent access to such agents
and toxins for use in domestic or international
terrorism or for any other criminal purpose;
(3) the establishment of procedures to protect the
public safety in the event of a transfer or potential
transfer of such an agent or toxin in violation of the
safety procedures established under paragraph (1) or
the safeguard and security measures established under
paragraph (2); and
(4) appropriate availability of biological agents
and toxins for research, education, and other
legitimate purposes.
(c) Possession and Use of Listed Agents and Toxins.--The
Secretary shall by regulation provide for the establishment and
enforcement of standards and procedures governing the
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect the public health and
safety.
(d) Registration; Identification; Database.--
(1) Registration.--Regulations under subsections
(b) and (c) shall require registration with the
Secretary of the possession, use, and transfer of
listed agents and toxins, and shall include provisions
to ensure that persons seeking to register under such
regulations have a lawful purpose to possess, use, or
transfer such agents and toxins, including provisions
in accordance with subsection (e)(6).
(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration
include (if available to the person registering)
information regarding the characterization of listed
agents and toxins to facilitate their identification,
including their source. The Secretary shall maintain a
national database that includes the names and locations
of registered persons, the listed agents and toxins
such persons are possessing, using, or transferring,
and information regarding the characterization of such
agents and toxins.
(e) Safeguard and Security Requirements for Registered
Persons.--
(1) In general.--Regulations under subsections (b)
and (c) shall include appropriate safeguard and
security requirements for persons possessing, using, or
transferring a listed agent or toxin commensurate with
the risk such agent or toxin poses to public health and
safety (including the risk of use in domestic or
international terrorism). The Secretary shall establish
such requirements in collaboration with the Secretary
of Homeland Security and the Attorney General, and
shall ensure compliance with such requirements as part
of the registration system under such regulations.
(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include
provisions to ensure that registered persons--
(A) provide access to listed agents and
toxins to only those individuals whom the
registered person involved determines have a
legitimate need to handle or use such agents
and toxins;
(B) submit the names and other identifying
information for such individuals to the
Secretary and the Attorney General, promptly
after first determining that the individuals
need access under subparagraph (A), and
periodically thereafter while the individuals
have such access, not less frequently than once
every five years;
(C) deny access to such agents and toxins
by individuals whom the Attorney General has
identified as restricted persons; and
(D) limit or deny access to such agents and
toxins by individuals whom the Attorney General
has identified as within any category under
paragraph (3)(B)(ii), if limiting or denying
such access by the individuals involved is
determined appropriate by the Secretary, in
consultation with the Attorney General.
(3) Submitted names; use of databases by attorney
general.--
(A) In general.--Upon the receipt of names
and other identifying information under
paragraph (2)(B), the Attorney General shall,
for the sole purpose of identifying whether the
individuals involved are within any of the
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose.
(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in
this subparagraph regarding an individual are
that--
(i) the individual is a restricted
person; or
(ii) the individual is reasonably
suspected by any Federal law
enforcement or intelligence agency of--
(I) committing a crime set
forth in section 2332b(g)(5) of
title 18, United States Code;
(II) knowing involvement
with an organization that
engages in domestic or
international terrorism (as
defined in section 2331 of such
title 18) or with any other
organization that engages in
intentional crimes of violence;
or
(III) being an agent of a
foreign power (as defined in
section 1801 of title 50,
United States Code).
(C) Notification by attorney general
regarding submitted names.--After the receipt
of a name and other identifying information
under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the
individual is within any of the categories
specified in subparagraph (B).
(4) Notifications by secretary.--The Secretary,
after receiving notice under paragraph (3) regarding an
individual, shall promptly notify the registered person
involved of whether the individual is granted or denied
access under paragraph (2). If the individual is denied
such access, the Secretary shall promptly notify the
individual of the denial.
(5) Expedited review.--Regulations under
subsections (b) and (c) shall provide for a procedure
through which, upon request to the Secretary by a
registered person who submits names and other
identifying information under paragraph (2)(B) and who
demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
(A) request the Attorney General to
expedite the process of identification under
paragraph (3)(A) and notification of the
Secretary under paragraph (3)(C); and
(B) expedite the notification of the
registered person by the Secretary under
paragraph (4).
(6) Process regarding persons seeking to
register.--
(A) Individuals.--Regulations under
subsections (b) and (c) shall provide that an
individual who seeks to register under either
of such subsections is subject to the same
processes described in paragraphs (2) through
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph.
(B) Other persons.--Regulations under
subsections (b) and (c) shall provide that, in
determining whether to deny or revoke
registration by a person other than an
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is a restricted person or
is reasonably suspected by any Federal law
enforcement or intelligence agency of being
within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide
that a person who seeks to register under
either of such subsections is subject to the
same processes described in paragraphs (2) and
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under
subsections (b) and (c) shall provide
for an opportunity for a review by the
Secretary--
(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
(II) when requested by the
person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise national security or an
investigation by any law enforcement
agency.
(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5, United States Code.
(B) Certain procedures.--
(i) Submission of ex parte
materials in judicial proceedings.--
When reviewing a decision of the
Secretary under subparagraph (A), and
upon request made ex parte and in
writing by the United States, a court,
upon a sufficient showing, may review
and consider ex parte documents
containing information the disclosure
of which could compromise national
security or an investigation by any law
enforcement agency. If the court
determines that portions of the
documents considered ex parte should be
disclosed to the person involved to
allow a response, the court shall
authorize the United States to delete
from such documents specified items of
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency, or to substitute a summary of
the information to which the person may
respond. Any order by the court
authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States
Code (relating to interlocutory appeal
and expedited consideration).
(ii) Disclosure of information.--In
a review under subparagraph (A), and in
any judical proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under subsection
(h) shall not be disclosed under
section 552 of title 5, United States
Code.
(8) Notifications regarding theft or loss of
agents.--Requirements under paragraph (1) shall include
the prompt notification of the Secretary, and
appropriate Federal, State, and local law enforcement
agencies, of the theft or loss of listed agents and
toxins.
(9) Technical assistance for registered persons.--
The Secretary, in consultation with the Attorney
General, may provide technical assistance to registered
persons to improve security of the facilities of such
persons.
(f) Inspections.--The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b) or
(c) to ensure their compliance with such regulations, including
prohibitions on restricted persons and other provisions of
subsection (e).
(g) Exemptions.--
(1) Clinical or diagnostic laboratories.--
Regulations under subsections (b) and (c) shall exempt
clinical or diagnostic laboratories and other persons
who possess, use, or transfer listed agents or toxins
that are contained in specimens presented for
diagnosis, verification, or proficiency testing,
provided that--
(A) the identification of such agents or
toxins is reported to the Secretary, and when
required under Federal, State, or local law, to
other appropriate authorities; and
(B) such agents or toxins are transferred
or destroyed in a manner set forth by the
Secretary by regulation.
(2) Products.--
(A) In general.--Regulations under
subsections (b) and (c) shall exempt products
that are, bear, or contain listed agents or
toxins and are cleared, approved, licensed, or
registered under any of the Acts specified in
subparagraph (B), unless the Secretary by order
determines that applying additional regulation
under subsection (b) or (c) to a specific
product is necessary to protect public health
and safety.
(B) Relevant laws.--For purposes of
subparagraph (A), the Acts specified in this
subparagraph are the following:
(i) The Federal Food, Drug, and
Cosmetic Act.
(ii) Section 351 of this Act.
(iii) The Act commonly known as the
Virus-Serum-Toxin Act (the eighth
paragraph under the heading ``Bureau of
Animal Industry'' in the Act of March
4, 1913; 21 U.S.C. 151-159).
(iv) The Federal Insecticide,
Fungicide, and Rodenticide Act.
(C) Investigational use.--
(i) In general.--The Secretary may
exempt an investigational product that
is, bears, or contains a listed agent
or toxin from the applicability of
provisions of regulations under
subsection (b) or (c) when such product
is being used in an investigation
authorized under any Federal Act and
the Secretary determines that applying
additional regulation under subsection
(b) or (c) to such product is not
necessary to protect public health and
safety.
(ii) Certain processes.--
Regulations under subsections (b) and
(c) shall set forth the procedures for
applying for an exemption under clause
(i). In the case of investigational
products authorized under any of the
Acts specified in subparagraph (B), the
Secretary shall make a determination
regarding a request for an exemption
not later than 14 days after the first
date on which both of the following
conditions have been met by the person
requesting the exemption:
(I) The person has
submitted to the Secretary an
application for the exemption
meeting the requirements
established by the Secretary.
(II) The person has
notified the Secretary that the
investigation has been
authorized under such an Act.
(3) Public health emergencies.--The Secretary may
temporarily exempt a person from the applicability of
the requirements of this section, in whole or in part,
if the Secretary determines that such exemption is
necessary to provide for the timely participation of
the person in a response to a domestic or foreign
public health emergency (whether determined under
section 319(a) or otherwise) that involves a listed
agent or toxin. With respect to the emergency involved,
such exemption for a person may not exceed 30 days,
except that the Secretary, after review of whether such
exemption remains necessary, may provide one extension
of an additional 30 days.
(4) Agricultural emergencies.--Upon request of the
Secretary of Agriculture, after the granting by such
Secretary of an exemption under section 212(g)(1)(D) of
the Agricultural Bioterrorism Protection Act of 2002
pursuant to a finding that there is an agricultural
emergency, the Secretary of Health and Human Services
may temporarily exempt a person from the applicability
of the requirements of this section, in whole or in
part, to provide for the timely participation of the
person in a response to the agricultural emergency.
With respect to the emergency involved, the exemption
under this paragraph for a person may not exceed 30
days, except that upon request of the Secretary of
Agriculture, the Secretary of Health and Human Services
may, after review of whether such exemption remains
necessary, provide one extension of an additional 30
days.
(h) Disclosure of Information.--
(1) Nondisclosure of certain information.--No
Federal agency specified in paragraph (2) shall
disclose under section 552 of title 5, United States
Code, any of the following:
(A) Any registration or transfer
documentation submitted under subsections (b)
and (c) for the possession, use, or transfer of
a listed agent or toxin; or information derived
therefrom to the extent that it identifies the
listed agent or toxin possessed, used, or
transferred by a specific registered person or
discloses the identity or location of a
specific registered person.
(B) The national database developed
pursuant to subsection (d), or any other
compilation of the registration or transfer
information submitted under subsections (b) and
(c) to the extent that such compilation
discloses site-specific registration or
transfer information.
(C) Any portion of a record that discloses
the site-specific or transfer-specific
safeguard and security measures used by a
registered person to prevent unauthorized
access to listed agents and toxins.
(D) Any notification of a release of a
listed agent or toxin submitted under
subsections (b) and (c), or any notification of
theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report
of an inspection of a specific registered
person conducted under subsection (f) that
identifies the listed agent or toxin possessed
by a specific registered person or that
discloses the identity or location of a
specific registered person if the agency
determines that public disclosure of the
information would endanger public health or
safety.
(2) Covered agencies.--For purposes of paragraph
(1) only, the Federal agencies specified in this
paragraph are the following:
(A) The Department of Health and Human
Services, the Department of Justice, the
Department of Agriculture, and the Department
of Transportation.
(B) Any Federal agency to which information
specified in paragraph (1) is transferred by
any agency specified in subparagraph (A) of
this paragraph.
(C) Any Federal agency that is a registered
person, or has a sub-agency component that is a
registered person.
(D) Any Federal agency that awards grants
or enters into contracts or cooperative
agreements involving listed agents and toxins
to or with a registered person, and to which
information specified in paragraph (1) is
transferred by any such registered person.
(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions
to public disclosure under section 552 of title 5,
United States Code, except as to subsection 552(b)(3)
of such title, to any of the information specified in
paragraph (1).
(4) Rule of construction.--Except as specifically
provided in paragraph (1), this subsection may not be
construed as altering the authority of any Federal
agency to withhold under section 552 of title 5, United
States Code, or the obligation of any Federal agency to
disclose under section 552 of title 5, United States
Code, any information, including information relating
to--
(A) listed agents and toxins, or
individuals seeking access to such agents and
toxins;
(B) registered persons, or persons seeking
to register their possession, use, or transfer
of such agents and toxins;
(C) general safeguard and security policies
and requirements under regulations under
subsections (b) and (c); or
(D) summary or statistical information
concerning registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
(5) Disclosures to congress; other disclosures.--
This subsection may not be construed as providing any
authority--
(A) to withhold information from the
Congress or any committee or subcommittee
thereof; or
(B) to withhold information from any person
under any other Federal law or treaty.
(i) Civil Money Penalty.-- \1\
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\1\ Section 175b of title 18, United States Code, establishes
criminal penalties relating to biological agents or toxins that are
listed as select agents in Appendix A of part 72 of title 42, Code of
Federal Regulations, pursuant to section 351A above, and are not
exempted under subsection (h) of section 72.6, or Appendix A of part
72, of title 42, Code of Federal Regulations.
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(1) In general.--In addition to any other penalties
that may apply under law, any person who violates any
provision of regulations under subsection (b) or (c)
shall be subject to the United States for a civil money
penalty in an amount not exceeding $250,000 in the case
of an individual and $500,000 in the case of any other
person.
(2) Applicability of certain provisions.--The
provisions of section 1128A of the Social Security Act
(other than subsections (a), (b), (h), and (i), the
first sentence of subsection (c), and paragraphs (1)
and (2) of subsection (f)) shall apply to a civil money
penalty under paragraph (1) in the same manner as such
provisions apply to a penalty or proceeding under
section 1128A(a) of such Act. The Secretary may
delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social
Security Act, and such authority shall include all
powers as contained in section 6 of the Inspector
General Act of 1978 (5 U.S.C. App.).
(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification
of the Secretary by a registered person whenever a release,
meeting criteria established by the Secretary, of a listed
agent or toxin has occurred outside of the biocontainment area
of a facility of the registered person. Upon receipt of such
notification and a finding by the Secretary that the release
poses a threat to public health or safety, the Secretary shall
take appropriate action to notify relevant State and local
public health authorities, other relevant Federal authorities,
and, if necessary, other appropriate persons (including the
public). If the released listed agent or toxin is an overlap
agent or toxin (as defined in subsection (l)), the Secretary
shall promptly notify the Secretary of Agriculture upon
notification by the registered person.
(k) Reports.--The Secretary shall report to the Congress
annually on the number and nature of notifications received
under subsection (e)(8) (relating to theft or loss) and
subsection (j) (relating to releases).
(l) Definitions.--For purposes of this section:
(1) The terms ``biological agent'' and ``toxin''
have the meanings given such terms in section 178 of
title 18, United States Code.
(2) The term ``listed agents and toxins'' means
biological agents and toxins listed pursuant to
subsection (a)(1).
(3) The term ``listed agents or toxins'' means
biological agents or toxins listed pursuant to
subsection (a)(1).
(4) The term ``overlap agents and toxins'' means
biological agents and toxins that--
(A) are listed pursuant to subsection
(a)(1); and
(B) are listed pursuant to section
212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002.
(5) The term ``overlap agent or toxin'' means a
biological agent or toxin that--
(A) is listed pursuant to subsection
(a)(1); and
(B) is listed pursuant to section 212(a)(1)
of the Agricultural Bioterrorism Protection Act
of 2002.
(6) The term ``person'' includes Federal, State,
and local governmental entities.
(7) The term ``registered person'' means a person
registered under regulations under subsection (b) or
(c).
(8) The term ``restricted person'' has the meaning
given such term in section 175b of title 18, United
States Code.
(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007.
preparation of biological products
Sec. 352. [263] (a) The Service may prepare for its own use
any product described in section 351 and any product necessary
to carrying out any of the purposes of section 301.
(b) The Service may prepare any product described in
section 351 for the use of other Federal departments or
agencies, and public or private agencies and individuals
engaged in work in the field of medicine when such product is
not available from establishments licensed under such section.
Subpart 2--Clinical Laboratories
h3 deg.certification of laboratories
Sec. 353. [263a] (a) Definition.--As used in this section,
the term ``laboratory'' or ``clinical laboratory'' means a
facility for the biological, microbiological, serological,
chemical, immuno-hematological, hematological, biophysical,
cytological, pathological, or other examination of materials
derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any
disease or impairment of, or the assessment of the health of,
human beings.
(b) Certificate Requirement.--No person may solicit or
accept materials derived from the human body for laboratory
examination or other procedure unless there is in effect for
the laboratory a certificate issued by the Secretary under this
section applicable to the category of examinations or
procedures which includes such examination or procedure.
(c) Issuance and Renewal of Certificates.--
(1) In general.--The Secretary may issue or renew a
certificate for a laboratory only if the laboratory
meets the requirements of subsection (d).
(2) Term.--A certificate issued under this section
shall be valid for a period of 2 years or such shorter
period as the Secretary may establish.
(d) Requirements for Certificates.--
(1) In general.--A laboratory may be issued a
certificate or have its certificate renewed if--
(A) the laboratory submits (or if the
laboratory is accredited under subsection (e),
the accreditation body which accredited the
laboratory submits), an application--
(i) in such form and manner as the
Secretary shall prescribe,
(ii) that describes the
characteristics of the laboratory
examinations and other procedures
performed by the laboratory including--
(I) the number and types of
laboratory examinations and
other procedures performed,
(II) the methodologies for
laboratory examinations and
other procedures employed, and
(III) the qualifications
(educational background,
training, and experience) of
the personnel directing and
supervising the laboratory and
performing the laboratory
examinations and other
procedures, and
(iii) that contains such other
information as the Secretary may
require to determine compliance with
this section, and
the laboratory agrees to provide to the
Secretary (or if the laboratory is accredited,
to the accreditation body which accredited it)
a description of any change in the information
submitted under clause (ii) not later than 6
months after the change was put into effect,
(B) the laboratory provides the Secretary--
(i) with satisfactory assurances
that the laboratory will be operated in
accordance with standards issued by the
Secretary under subsection (f), or
(ii) with proof of accreditation
under subsection (e),
(C) the laboratory agrees to permit
inspections by the Secretary under subsection
(g),
(D) the laboratory agrees to make records
available and submit reports to the Secretary
as the Secretary may reasonably require, and
(E) the laboratory agrees to treat
proficiency testing samples in the same manner
as it treats materials derived from the human
body referred to it for laboratory examinations
or other procedures in the ordinary course of
business.
(2) Requirements for certificates of waiver.--
(A) In general.--A laboratory which only
performs laboratory examinations and procedures
described in paragraph (3) shall be issued a
certificate of waiver or have its certificate
of waiver renewed if--
(i) the laboratory submits an
application--
(I) in such form and manner
as the Secretary shall
prescribe,
(II) that describes the
characteristics of the
laboratory examinations and
other procedures performed by
the laboratory, including the
number and types of laboratory
examinations and other
procedures performed, the
methodologies for laboratory
examinations and other
procedures employed, and the
qualifications (educational
background, training, and
experience) of the personnel
directing and supervising the
laboratory and performing the
laboratory examinations and
other procedures, and
(III) that contains such
other information as the
Secretary may reasonably
require to determine compliance
with this section, and
(ii) the laboratory agrees to make
records available and submit reports to
the Secretary as the Secretary may
require.
(B) Changes.--If a laboratory makes changes
in the examinations and other procedures
performed by it only with respect to
examinations and procedures which are described
in paragraph (3), the laboratory shall report
such changes to the Secretary not later than 6
months after the change has been put into
effect. If a laboratory proposes to make
changes in the examinations and procedures
performed by it such that the laboratory will
perform an examination or procedure not
described in paragraph (3), the laboratory
shall report such change to the Secretary
before the change takes effect.
(C) Effect.--Subsections (f) and (g) shall
not apply to a laboratory to which has been
issued a certificate of waiver.
(3) Examinations and procedures.--The examinations
and procedures identified in paragraph (2) are
laboratory examinations and procedures that have been
approved by the Food and Drug Administration for home
use or that, as determined by the Secretary, are simple
laboratory examinations and procedures that have an
insignificant risk of an erroneous result, including
those that--
(A) employ methodologies that are so simple
and accurate as to render the likelihood of
erroneous results by the user negligible, or
(B) the Secretary has determined pose no
unreasonable risk of harm to the patient if
performed incorrectly.
(4) Definition.--As used in this section, the term
``certificate'' includes a certificate of waiver issued
under paragraph (2).
(e) Accreditation.--
(1) In general.--A laboratory may be accredited for
purposes of obtaining a certificate if the laboratory--
(A) meets the standards of an approved
accreditation body, and
(B) authorizes the accreditation body to
submit to the Secretary (or such State agency
as the Secretary may designate) such records or
other information as the Secretary may require.
(2) Approval of accreditation bodies.--
(A) In general.--The Secretary may approve
a private nonprofit organization to be an
accreditation body for the accreditation of
laboratories if--
(i) using inspectors qualified to
evaluate the methodologies used by the
laboratories in performing laboratory
examinations and other procedures, the
accreditation body agrees to inspect a
laboratory for purposes of
accreditation with such frequency as
determined by Secretary, \1\
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\1\ So in law. Probably should be ``the Secretary''.
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(ii) the standards applied by the
body in determining whether or not to
accredit a laboratory are equal to or
more stringent than the standards
issued by the Secretary under
subsection (f),
(iii) there is adequate provision
for assuring that the standards of the
accreditation body continue to be met
by the laboratory,
(iv) in the case of any laboratory
accredited by the body which has had
its accreditation denied, suspended,
withdrawn, or revoked or which has had
any other action taken against it by
the accrediting body, the accrediting
body agrees to submit to the Secretary
the name of such laboratory within 30
days of the action taken,
(v) the accreditation body agrees
to notify the Secretary at least 30
days before it changes its standards,
and
(vi) if the accreditation body has
its approval withdrawn by the
Secretary, the body agrees to notify
each laboratory accredited by the body
of the withdrawal within 10 days of the
withdrawal.
(B) Criteria and procedures.--The Secretary
shall promulgate criteria and procedures for
approving an accreditation body and for
withdrawing such approval if the Secretary
determines that the accreditation body does not
meet the requirements of subparagraph (A).
(C) Effect of withdrawal of approval.--If
the Secretary withdraws the approval of an
accreditation body under subparagraph (B), the
certificate of any laboratory accredited by the
body shall continue in effect for 60 days after
the laboratory receives notification of the
withdrawal of the approval, except that the
Secretary may extend such period for a
laboratory if it \1\ determines that the
laboratory submitted an application for
accreditation or a certificate in a timely
manner after receipt of the notification of the
withdrawal of approval. If an accreditation
body withdraws or revokes the accreditation of
a laboratory, the certificate of the laboratory
shall continue in effect--
(i) for 45 days after the
laboratory receives notice of the
withdrawal or revocation of the
accreditation, or
(ii) until the effective date of
any action taken by the Secretary under
subsection (i).
(D) Evaluations.--The Secretary shall
evaluate annually the performance of each
approved accreditation body by--
(i) inspecting under subsection (g)
a sufficient number of the laboratories
accredited by such body to allow a
reasonable estimate of the performance
of such body, and
(ii) such other means as the
Secretary determines appropriate.
(3) Report.--The Secretary shall annually prepare
and submit, to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Labor
and Human Resources of the Senate, a report that
describes the results of the evaluation conducted under
paragraph (2)(D).
(f) \1\ Standards.--
---------------------------------------------------------------------------
\1\ Section 3 of Public Law 100-578 provides that, with respect to
subsection (g)(1) and subsections (h) through (m), any reference made
in any of such subsections to the standards established under
subsection (f) ``shall be considered a reference to the standards
established under subsection (d) [of section 353], as in effect on
December 31, 1988.''.
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(1) In general.--The Secretary shall issue
standards to assure consistent performance by
laboratories issued a certificate under this section of
valid and reliable laboratory examinations and other
procedures. Such standards shall require each
laboratory issued a certificate under this section--
(A) to maintain a quality assurance and
quality control program adequate and
appropriate for the validity and reliability of
the laboratory examinations and other
procedures of the laboratory and to meet
requirements relating to the proper collection,
transportation, and storage of specimens and
the reporting of results,
(B) to maintain records, equipment, and
facilities necessary for the proper and
effective operation of the laboratory,
(C) in performing and carrying out its
laboratory examinations and other procedures,
to use only personnel meeting such
qualifications as the Secretary may establish
for the direction, supervision, and performance
of examinations and procedures within the
laboratory, which qualifications shall take
into consideration competency, training,
experience, job performance, and education and
which qualifications shall, as appropriate, be
different on the basis of the type of
examinations and procedures being performed by
the laboratory and the risks and consequences
of erroneous results associated with such
examinations and procedures,
(D) to qualify under a proficiency testing
program meeting the standards established by
the Secretary under paragraph (3), and
(E) to meet such other requirements as the
Secretary determines necessary to assure
consistent performance by such laboratories of
accurate and reliable laboratory examinations
and procedures.
(2) Considerations.--In developing the standards to
be issued under paragraph (1), the Secretary shall,
within the flexibility provided under subparagraphs (A)
through (E) of paragraph (1), take into consideration--
(A) the examinations and procedures
performed and the methodologies employed,
(B) the degree of independent judgment
involved,
(C) the amount of interpretation involved,
(D) the difficulty of the calculations
involved,
(E) the calibration and quality control
requirements of the instruments used,
(F) the type of training required to
operate the instruments used in the
methodology, and
(G) such other factors as the Secretary
considers relevant.
(3) Proficiency testing program.--
(A) In general.--The Secretary shall
establish standards for the proficiency testing
programs for laboratories issued a certificate
under this section which are conducted by the
Secretary, conducted by an organization
approved under subparagraph (C), or conducted
by an approved accrediting body. The standards
shall require that a laboratory issued a
certificate under this section be tested for
each examination and procedure conducted within
a category of examinations or procedures for
which it has received a certificate, except for
examinations and procedures for which the
Secretary has determined that a proficiency
test cannot reasonably be developed. The
testing shall be conducted on a quarterly
basis, except where the Secretary determines
for technical and scientific reasons that a
particular examination or procedure may be
tested less frequently (but not less often than
twice per year).
(B) Criteria.--The standards established
under subparagraph (A) shall include uniform
criteria for acceptable performance under a
proficiency testing program, based on the
available technology and the clinical relevance
of the laboratory examination or other
procedure subject to such program. The criteria
shall be established for all examinations and
procedures and shall be uniform for each
examination and procedure. The standards shall
also include a system for grading proficiency
testing performance to determine whether a
laboratory has performed acceptably for a
particular quarter and acceptably for a
particular examination or procedure or category
of examination or procedure over a period of
successive quarters.
(C) Approved proficiency testing
programs.--For the purpose of administering
proficiency testing programs which meet the
standards established under subparagraph (A),
the Secretary shall approve a proficiency
testing program offered by a private nonprofit
organization or a State if the program meets
the standards established under subparagraph
(A) and the organization or State provides
technical assistance to laboratories seeking to
qualify under the program. The Secretary shall
evaluate each program approved under this
subparagraph annually to determine if the
program continues to meet the standards
established under subparagraph (A) and shall
withdraw the approval of any program that no
longer meets such standards.
(D) On-site \1\ testing.--The Secretary
shall perform, or shall direct a program
approved under subparagraph (C) to perform,
onsite proficiency testing to assure compliance
with the requirements of subsection (d)(5) \2\.
The Secretary shall perform, on an onsite or
other basis, proficiency testing to evaluate
the performance of a proficiency testing
program approved under subparagraph (C) and to
assure quality performance by a laboratory.
---------------------------------------------------------------------------
\1\ So in law. Probably should not be hyphenated. Compare with text
of subparagraph (D).
\2\ So in law. Probably should be ``(d)(1)(E)''.
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(E) Training, technical assistance, and
enhanced proficiency testing.--The Secretary
may, in lieu of or in addition to actions
authorized under subsection (h), (i), or (j),
require any laboratory which fails to perform
acceptably on an individual examination and
procedure or a category of examination and
procedures--
(i) to undertake training and to
obtain the necessary technical
assistance to meet the requirements of
the proficency \1\ testing program,
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``proficiency''.
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(ii) to enroll in a program of
enhanced proficiency testing, or
(iii) to undertake any combination
of the training, technical assistance,
or testing described in clauses (i) and
(ii).
(F) Testing results.--The Secretary shall
establish a system to make the results of the
proficiency testing programs subject to the
standards established by the Secretary under
subparagraph (A) available, on a reasonable
basis, upon request of any person. The
Secretary shall include with results made
available under this subparagraph such
explanatory information as may be appropriate
to assist in the interpretation of such
results.
(4) National standards for quality assurance in
cytology services.--
(A) Establishment.--The Secretary shall
establish national standards for quality
assurance in cytology services designed to
assure consistent performance by laboratories
of valid and reliable cytological services.
(B) Standards.--The standards established
under subparagraph (A) shall include--
(i) the maximum number of cytology
slides that any individual may screen
in a 24-hour period,
(ii) requirements that a clinical
laboratory maintain a record of (I) the
number of cytology slides screened
during each 24-hour period by each
individual who examines cytology slides
for the laboratory, and (II) the number
of hours devoted during each 24-hour
period to screening cytology slides by
such individual,
(iii) criteria for requiring
rescreening of cytological
preparations, such as (I) random
rescreening of cytology specimens
determined to be in the benign
category, (II) focused rescreening of
such preparations in high risk groups,
and (III) for each abnormal cytological
result, rescreening of all prior
cytological specimens for the patient,
if available,
(iv) periodic confirmation and
evaluation of the proficiency of
individuals involved in screening or
interpreting cytological preparations,
including announced and unannounced on-
site \2\ proficiency testing of such
individuals, with such testing to take
place, to the extent practicable, under
normal working conditions,
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\2\ See footnote 1 for paragraph (3)(D).
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(v) procedures for detecting
inadequately prepared slides, for
assuring that no cytological diagnosis
is rendered on such slides, and for
notifying referring physicians of such
slides,
(vi) requirements that all
cytological screening be done on the
premises of a laboratory that is
certified under this section,
(vii) requirements for the
retention of cytology slides by
laboratories for such periods of time
as the Secretary considers appropriate,
and
(viii) standards requiring periodic
inspection of cytology services by
persons capable of evaluating the
quality of cytology services.
(g) Inspections.--
(1) in general.--The Secretary may, on an announced
or unannounced basis, enter and inspect, during regular
hours of operation, laboratories which have been issued
a certificate under this section. In conducting such
inspections the Secretary shall have access to all
facilities, equipment, materials, records, and
information that the Secretary determines have a
bearing on whether the laboratory is being operated in
accordance with this section. As part of such an
inspection the Secretary may copy any such material or
require to it be \1\ submitted to the Secretary. An
inspection under this paragraph may be made only upon
presenting identification to the owner, operator, or
agent in charge of the laboratory being inspected.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``require it to be''.
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(2) Compliance with requirements and standards.--
The Secretary shall conduct inspections of laboratories
under paragraph (1) to determine their compliance with
the requirements of subsection (d) and the standards
issued under subsection (f). Inspections of
laboratories not accredited under subsection (e) shall
be conducted on a biennial basis or with such other
frequency as the Secretary determines to be necessary
to assure compliance with such requirements and
standards. Inspections of laboratories accredited under
subsection (e) shall be conducted on such basis as the
Secretary determines is necessary to assure compliance
with such requirements and standards.
(h) Intermediate Sanctions.--
(1) In general.--If the Secretary determines that a
laboratory which has been issued a certificate under
this section no longer substantially meets the
requirements for the issuance of a certificate, the
Secretary may impose intermediate sanctions in lieu of
the actions authorized by subsection (i).
(2) Types of sanctions.--The intermediate sanctions
which may be imposed under paragraph (1) shall consist
of--
(A) directed plans of correction,
(B) civil money penalties in an amount not
to exceed $10,000 for each violation listed in
subsection (i)(1) or for each day of
substantial noncompliance with the requirements
of this section,
(C) payment for the costs of onsite
monitoring, or
(D) any combination of the actions
described in subparagraphs (A), (B), and (C).
(3) Procedures.--The Secretary shall develop and
implement procedures with respect to when and how each
of the intermediate sanctions is to be imposed under
paragraph (1). Such procedures shall provide for notice
to the laboratory and a reasonable opportunity to
respond to the proposed sanction and appropriate
procedures for appealing determinations relating to the
imposition of intermediate sanctions \1\
---------------------------------------------------------------------------
\1\ So in law. The sentence lacks a period.
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(i) Suspension, Revocation, and Limitation.--
(1) In general.--Except as provided in paragraph
(2), the certificate of a laboratory issued under this
section may be suspended, revoked, or limited if the
Secretary finds, after reasonable notice and
opportunity for hearing to the owner or operator of the
laboratory, that such owner or operator or any employee
of the laboratory--
(A) has been guilty of misrepresentation in
obtaining the certificate,
(B) has performed or represented the
laboratory as entitled to perform a laboratory
examination or other procedure which is not
within a category of laboratory examinations or
other procedures authorized in the certificate,
(C) has failed to comply with the
requirements of subsection (d) or the standards
prescribed by the Secretary under subsection
(f),
(D) has failed to comply with reasonable
requests of the Secretary for--
(i) any information or materials,
or
(ii) work on materials,
that the Secretary concludes is necessary to
determine the laboratory's continued
eligibility for its certificate or continued
compliance with the Secretary's standards under
subsection (f),
(E) has refused a reasonable request of the
Secretary, or any Federal officer or employee
duly designated by the Secretary, for
permission to inspect the laboratory and its
operations and pertinent records during the
hours the laboratory is in operation,
(F) has violated or aided and abetted in
the violation of any provisions of this section
or of any regulation promulgated thereunder, or
(G) has not complied with an intermediate
sanction imposed under subsection (h).
(2) Action before a hearing.--If the Secretary
determines that--
(A) the failure of a laboratory to comply
with the standards of the Secretary under
subsection (f) presents an imminent and serious
risk to human health, or
(B) a laboratory has engaged in an action
described in subparagraph (D) or (E) of
paragraph (1),
the Secretary may suspend or limit the certificate of
the laboratory before holding a hearing under paragraph
(1) regarding such failure or refusal. The opportunity
for a hearing shall be provided no later than 60 days
from the effective date of the suspension or
limitation. A suspension or limitation under this
paragraph shall stay in effect until the decision of
the Secretary made after the hearing under paragraph
(1).
(3) Ineligibility to own or operate laboratories
after revocation.--No person who has owned or operated
a laboratory which has had its certificate revoked may,
within 2 years of the revocation of the certificate,
own or operate a laboratory for which a certificate has
been issued under this section. The certificate of a
laboratory which has been excluded from participation
under the medicare program under title XVIII of the
Social Security Act because of actions relating to the
quality of the laboratory shall be suspended for the
period the laboratory is so excluded.
(4) Improper referrals.--Any laboratory that the
Secretary determines intentionally refers its
proficiency testing samples to another laboratory for
analysis shall have its certificate revoked for at
least one year and shall be subject to appropriate
fines and penalties as provided for in subsection (h).
(j) Injunctions.--Whenever the Secretary has reason to
believe that continuation of any activity by a laboratory would
constitute a significant hazard to the public health the
Secretary may bring suit in the district court of the United
States for the district in which such laboratory is situated to
enjoin continuation of such activity. Upon proper showing, a
temporary injunction or restraining order against continuation
of such activity pending issuance of a final order under this
subsection shall be granted without bond by such court.
(k) Judicial Review.--
(1) Petition.--Any laboratory which has had an
intermediate sanction imposed under subsection (h) or
has had its certificate suspended, revoked, or limited
under subsection (i) may, at any time within 60 days
after the date the action of the Secretary under
subsection (i) or (h) becomes final, file a petition
with the United States court of appeals for the circuit
wherein the laboratory has its principal place of
business for judicial review of such action. As soon as
practicable after receipt of the petition, the clerk of
the court shall transmit a copy of the petition to the
Secretary or other officer designated by the Secretary
for that purpose. As soon as practicable after receipt
of the copy, the Secretary shall file in the court the
record on which the action of the Secretary is based,
as provided in section 2112 of title 28, United States
Code.
(2) Additional evidence.--If the petitioner applies
to the court for leave to adduce additional evidence,
and shows to the satisfaction of the court that such
additional evidence is material and that there were
reasonable grounds for the failure to adduce such
evidence in the proceeding before the Secretary, the
court may order such additional evidence (and evidence
in rebuttal of such additional evidence) to be taken
before the Secretary, and to be adduced upon the
hearing in such manner and upon such terms and
conditions as the court may deem proper. The Secretary
may modify the findings of the Secretary as to the
facts, or make new findings, by reason of the
additional evidence so taken, and the Secretary shall
file such modified or new findings, and the
recommendations of the Secretary, if any, for the
modification or setting aside of his original action,
with the return of such additional evidence.
(3) Judgment of court.--Upon the filing of the
petition referred to in paragraph (1), the court shall
have jurisdiction to affirm the action, or to set it
aside in whole or in part, temporarily or permanently.
The findings of the Secretary as to the facts, if
supported by substantial evidence, shall be conclusive.
(4) Finality of judgment.--The judgment of the
court affirming or setting aside, in whole or in part,
any such action of the Secretary shall be final,
subject to review by the Supreme Court of the United
States upon certiorari or certification as provided in
section 1254 of title 28, United States Code.
(l) Sanctions.--Any person who intentionally violates any
requirement of this section or any regulation promulgated
thereunder shall be imprisoned for not more than one year or
fined under title 18, United States Code or both, except that
if the conviction is for a second or subsequent violation of
such a requirement such person shall be imprisoned for not more
than 3 years or fined in accordance with title 18, United
States Code or both.
(m) Fees.--
(1) Certificate fees.--The Secretary shall require
payment of fees for the issuance and renewal of
certificates, except that the Secretary shall only
require a nominal fee for the issuance and renewal of
certificates of waiver.
(2) Additional fees.--The Secretary shall require
the payment of fees for inspections of laboratories
which are not accredited and for the cost of performing
proficiency testing on laboratories which do not
participate in proficiency testing programs approved
under subsection (f)(3)(C).
(3) Criteria.--
(A) Fees under paragraph (1).--Fees imposed
under paragraph (1) shall be sufficient to
cover the general costs of administering this
section, including evaluating and monitoring
proficiency testing programs approved under
subsection (f) and accrediting bodies and
implementing and monitoring compliance with the
requirements of this section.
(B) Fees under paragraph (2).--Fees imposed
under paragraph (2) shall be sufficient to
cover the cost of the Secretary in carrying out
the inspections and proficiency testing
described in paragraph (2).
(C) Fees imposed under paragraphs (1) and
(2).--Fees imposed under paragraphs (1) and (2)
shall vary by group or classification of
laboratory, based on such considerations as the
Secretary determines are relevant, which may
include the dollar volume and scope of the
testing being performed by the laboratories.
(n) Information.--On April 1, 1990 and annually thereafter,
the Secretary shall compile and make available to physicians
and the general public information, based on the previous
calendar year, which the Secretary determines is useful in
evaluating the performance of a laboratory, including--
(1) a list of laboratories which have been
convicted under Federal or State laws relating to fraud
and abuse, false billings, or kickbacks,
(2) a list of laboratories--
(A) which have had their certificates
revoked, suspended, or limited under subsection
(i), or
(B) which have been the subject of a
sanction under subsection (l),
together with a statement of the reasons for the
revocation, suspension, limitation, or sanction,
(3) a list of laboratories subject to intermediate
sanctions under subsection (h) together with a
statement of the reasons for the sanctions,
(4) a list of laboratories whose accreditation has
been withdrawn or revoked together with a statement of
the reasons for the withdrawal or revocation,
(5) a list of laboratories against which the
Secretary has taken action under subsection (j)
together with a statement of the reasons for such
action, and
(6) a list of laboratories which have been excluded
from participation under title XVIII or XIX of the
Social Security Act.
The information to be compiled under paragraphs (1) through (6)
shall be information for the calendar year preceding the date
the information is to be made available to the public and shall
be accompanied by such explanatory information as may be
appropriate to assist in the interpretation of the information
compiled under such paragraphs.
(o) Delegation.--In carrying out this section, the
Secretary may, pursuant to agreement, use the services or
facilities of any Federal or State or local public agency or
nonprofit private organization, and may pay therefor in advance
or by way of reimbursement, and in such installments, as the
Secretary may determine.
(p) State Laws.--
(1) Except as provided in paragraph (2), nothing in
this section shall be construed as affecting the power
of any State to enact and enforce laws relating to the
matters covered by this section to the extent that such
laws are not inconsistent with this section or with the
regulations issued under this section.
(2) If a State enacts laws relating to matters
covered by this section which provide for requirements
equal to or more stringent than the requirements of
this section or than the regulations issued under this
section, the Secretary may exempt clinical laboratories
in that State from compliance with this section.
(q) Consultations.--In carrying out this section, the
Secretary shall consult with appropriate private organizations
and public agencies.
Subpart 3--Mammography Facilities
SEC. 354. [263B] CERTIFICATION OF MAMMOGRAPHY FACILITIES.
(a) Definitions.--As used in this section:
(1) Accreditation body.--The term ``accreditation
body'' means a body that has been approved by the
Secretary under subsection (e)(1)(A) to accredit
mammography facilities.
(2) Certificate.--The term ``certificate'' means
the certificate described in subsection (b)(1).
(3) Facility.--
(A) In general.--The term ``facility''
means a hospital, outpatient department,
clinic, radiology practice, or mobile unit, an
office of a physician, or other facility as
determined by the Secretary, that conducts
breast cancer screening or diagnosis through
mammography activities. Such term does not
include a facility of the Department of
Veterans Affairs.
(B) Activities.--For the purposes of this
section, the activities of a facility include
the operation of equipment to produce the
mammogram, the processing of the film, the
initial interpretation of the mammogram and the
viewing conditions for that interpretation.
Where procedures such as the film processing,
or the interpretation of the mammogram are
performed in a location different from where
the mammogram is performed, the facility
performing the mammogram shall be responsible
for meeting the quality standards described in
subsection (f).
(4) Inspection.--The term ``inspection'' means an
onsite evaluation of the facility by the Secretary, or
State or local agency on behalf of the Secretary.
(5) Mammogram.--The term ``mammogram'' means a
radiographic image produced through mammography.
(6) Mammography.--The term ``mammography'' means
radiography of the breast.
(7) Survey.--The term ``survey'' means an onsite
physics consultation and evaluation performed by a
medical physicist as described in subsection (f)(1)(E).
(8) Review physician.--The term ``review
physician'' means a physician as prescribed by the
Secretary under subsection (f )(1)(D) who meets such
additional requirements as may be established by an
accreditation body under subsection (e) and approved by
the Secretary to review clinical images under
subsection (e)(1)(B)(i) on behalf of the accreditation
body.
(b) Certificate Requirement.--
(1) Certificate.--No facility may conduct an
examination or procedure described in paragraph (2)
involving mammography after October 1, 1994, unless the
facility obtains--
(A) a certificate or a temporary renewal
certificate--
(i) that is issued, and, if
applicable, renewed, by the Secretary
in accordance with paragraphs \1\ (1)
or (2) of subsection (c);
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\1\ So in law. Probably should be ``paragraph''. See section
2(1)(A)(ii) of Public Law 108-365 (118 Stat. 1738).
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(ii) that is applicable to the
examination or procedure to be
conducted; and
(iii) that is displayed prominently
in such facility; or
(B) a provisional certificate or a limited
provisional certificate--
(i) that is issued by the Secretary
in accordance with paragraphs (3) and
(4) of subsection (c);
(ii) that is applicable to the
examination or procedure to be
conducted; and
(iii) that is displayed prominently
in such facility.
The reference to a certificate in this section includes
a temporary renewal certificate, provisional
certificate, or a \2\ limited provisional certificate.
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\2\ So in law. The article ``a'' appears before both ``temporary
renewal certificate'' and ``limited provisional certificate''. See
section 2(1)(C) of Public Law 108-365 (118 Stat. 1738).
---------------------------------------------------------------------------
(2) Examination or procedure.--A facility shall
obtain a certificate in order to--
(A) operate radiological equipment that is
used to image the breast;
(B) provide for the interpretation of a
mammogram produced by such equipment at the
facility or under arrangements with a qualified
individual at a facility different from where
the mammography examination is performed; and
(C) provide for the processing of film
produced by such equipment at the facility or
under arrangements with a qualified individual
at a facility different from where the
mammography examination is performed.
(c) Issuance and Renewal of Certificates.--
(1) In general.--The Secretary may issue or renew a
certificate for a facility if the person or agent
described in subsection (d)(1)(A) meets the applicable
requirements of subsection (d)(1) with respect to the
facility. The Secretary may issue or renew a
certificate under this paragraph for not more than 3
years.
(2) Temporary renewal certificate.--The Secretary
may issue a temporary renewal certificate, for a period
of not to exceed 45 days, to a facility seeking
reaccreditation if the accreditation body has issued an
accreditation extension, for a period of not to exceed
45 days, for any of the following:
(A) The facility has submitted the required
materials to the accreditation body within the
established time frames for the submission of
such materials but the accreditation body is
unable to complete the reaccreditation process
before the certification expires.
(B) The facility has acquired additional or
replacement equipment, or has had significant
personnel changes or other unforeseen
situations that have caused the facility to be
unable to meet reaccreditation timeframes, but
in the opinion of the accreditation body have
not compromised the quality of mammography.
(3) Limited provisional certificate.--The Secretary
may, upon the request of an accreditation body, issue a
limited provisional certificate to an entity to enable
the entity to conduct examinations for educational
purposes while an onsite visit from an accreditation
body is in progress. Such certificate shall be valid
only during the time the site visit team from the
accreditation body is physically in the facility, and
in no case shall be valid for longer than 72 hours. The
issuance of a certificate under this paragraph, shall
not preclude the entity from qualifying for a
provisional certificate under paragraph (4).
(4) Provisional certificate.--The Secretary may
issue a provisional certificate for an entity to enable
the entity to qualify as a facility. The applicant for
a provisional certificate shall meet the requirements
of subsection (d)(1), except providing information
required by clauses (iii) and (iv) of subsection
(d)(1)(A). A provisional certificate may be in effect
no longer than 6 months from the date it is issued,
except that it may be extended once for a period of not
more than 90 days if the owner, lessor, or agent of the
facility demonstrates to the Secretary that without
such extension access to mammography in the geographic
area served by the facility would be significantly
reduced and if the owner, lessor, or agent of the
facility will describe in a report to the Secretary
steps that will be taken to qualify the facility for
certification under subsection (b)(1).
(d) Application for Certificate.--
(1) Submission.--The Secretary may issue or renew a
certificate for a facility if--
(A) the person who owns or leases the
facility or an authorized agent of the person,
submits to the Secretary, in such form and
manner as the Secretary shall prescribe, an
application that contains at a minimum--
(i) a description of the
manufacturer, model, and type of each
x-ray machine, image receptor, and
processor operated in the performance
of mammography by the facility;
(ii) a description of the
procedures currently used to provide
mammography at the facility,
including--
(I) the types of procedures
performed and the number of
such procedures performed in
the prior 12 months;
(II) the methodologies for
mammography; and
(III) the names and
qualifications (educational
background, training, and
experience) of the personnel
performing mammography and the
physicians reading and
interpreting the results from
the procedures;
(iii) proof of on-site survey by a
qualified medical physicist as
described in subsection (f)(1)(E); and
(iv) proof of accreditation in such
manner as the Secretary shall
prescribe; and
(B) the person or agent submits to the
Secretary--
(i) a satisfactory assurance that
the facility will be operated in
accordance with standards established
by the Secretary under subsection (f)
to assure the safety and accuracy of
mammography;
(ii) a satisfactory assurance that
the facility will--
(I) permit inspections
under subsection (g);
(II) make such records and
information available, and
submit such reports, to the
Secretary as the Secretary may
require; and
(III) update the
information submitted under
subparagraph (A) or assurances
submitted under this
subparagraph on a timely basis
as required by the Secretary;
and
(iii) such other information as the
Secretary may require.
An applicant shall not be required to provide in an
application under subparagraph (A) any information
which the applicant has supplied to the accreditation
body which accredited the applicant, except as required
by the Secretary.
(2) Appeal.--If the Secretary denies an application
for the certification of a facility submitted under
paragraph (1)(A), the Secretary shall provide the owner
or lessor of the facility or the agent of the owner or
lessor who submitted such application--
(A) a statement of the grounds on which the
denial is based, and
(B) an opportunity for an appeal in
accordance with the procedures set forth in
regulations of the Secretary published at part
498 of title 42, Code of Federal Regulations.
(3) Effect of denial.--If the application for the
certification of a facility is denied, the facility may
not operate unless the denial of the application is
overturned at the conclusion of the administrative
appeals process provided in the regulations referred to
in paragraph (2)(B).
(e) Accreditation.--
(1) Approval of accreditation bodies.--
(A) In general.--The Secretary may approve
a private nonprofit organization or State
agency to accredit facilities for purposes of
subsection (d)(1)(A)(iv) if the accreditation
body meets the standards for accreditation
established by the Secretary as described in
subparagraph (B) and provides the assurances
required by subparagraph (C).
(B) Standards.--The Secretary shall
establish standards for accreditation bodies,
including--
(i) standards that require an
accreditation body to perform--
(I) a review of clinical
images from each facility
accredited by such body not
less often than every 3 years
which review will be made by
qualified review physicians;
and
(II) a review of a random
sample of clinical images from
such facilities in each 3-year
period beginning October 1,
1994, which review will be made
by qualified review physicians;
(ii) standards that prohibit
individuals conducting the reviews
described in clause (i) from
maintaining any relationship to the
facility undergoing review which would
constitute a conflict of interest;
(iii) standards that limit the
imposition of fees for accreditation to
reasonable amounts;
(iv) standards that require as a
condition of accreditation that each
facility undergo a survey at least
annually by a medical physicist as
described in subsection (f)(1)(E) to
ensure that the facility meets the
standards described in subparagraphs
(A) and (B) of subsection (f)(1);
(v) standards that require
monitoring and evaluation of such
survey, as prescribed by the Secretary;
(vi) standards that are equal to
standards established under subsection
(f) which are relevant to accreditation
as determined by the Secretary; and
(vii) such additional standards as
the Secretary may require.
(C) Assurances.--The accrediting body shall
provide the Secretary satisfactory assurances
that the body will--
(i) comply with the standards as
described in subparagraph (B);
(ii) comply with the requirements
described in paragraph (4);
(iii) submit to the Secretary the
name of any facility for which the
accreditation body denies, suspends, or
revokes accreditation;
(iv) notify the Secretary in a
timely manner before the accreditation
body changes the standards of the body;
(v) notify each facility accredited
by the accreditation body if the
Secretary withdraws approval of the
accreditation body under paragraph (2)
in a timely manner; and
(vi) provide such other additional
information as the Secretary may
require.
(D) Regulations.--Not later than 9 months
after the date of the enactment of this
section, the Secretary shall promulgate
regulations under which the Secretary may
approve an accreditation body.
(2) Withdrawal of approval.--
(A) In general.--The Secretary shall
promulgate regulations under which the
Secretary may withdraw the approval of an
accreditation body if the Secretary determines
that the accreditation body does not meet the
standards under subparagraph (B) of paragraph
(1), the requirements of clauses (i) through
(vi) of subparagraph (C) of paragraph (1), or
the requirements of paragraph (4).
(B) Effect of withdrawal.--If the Secretary
withdraws the approval of an accreditation body
under subparagraph (A), the certificate of any
facility accredited by the body shall continue
in effect until the expiration of a reasonable
period, as determined by the Secretary, for
such facility to obtain another accreditation.
(3) Accreditation.--To be accredited by an approved
accreditation body a facility shall meet--
(A) the standards described in paragraph
(1)(B) which the Secretary determines are
applicable to the facility, and
(B) such other standards which the
accreditation body may require.
(4) Compliance.--To ensure that facilities
accredited by an accreditation body will continue to
meet the standards of the accreditation body, the
accreditation body shall--
(A) make onsite visits on an annual basis
of a sufficient number of the facilities
accredited by the body to allow a reasonable
estimate of the performance of the body; and
(B) take such additional measures as the
Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made after
providing such notice as the Secretary may require.
(5) Revocation of accreditation.--If an
accreditation body revokes the accreditation of a
facility, the certificate of the facility shall
continue in effect until such time as may be determined
by the Secretary.
(6) Evaluation and report.--
(A) Evaluation.--The Secretary shall
evaluate annually the performance of each
approved accreditation body by--
(i) inspecting under subsection
(g)(2) a sufficient number of the
facilities accredited by the body to
allow a reasonable estimate of the
performance of the body; and
(ii) such additional means as the
Secretary determines to be appropriate.
(B) Report.--The Secretary shall annually
prepare and submit to the Committee on Labor
and Human Resources of the Senate and the
Committee on Energy and Commerce of the House
of Representatives a report that describes the
results of the evaluation conducted in
accordance with subparagraph (A).
(f) Quality Standards.--
(1) In general.--The standards referred to in
subsection (d)(1)(B)(i) are standards established by
the Secretary which include--
(A) standards that require establishment
and maintenance of a quality assurance and
quality control program at each facility that
is adequate and appropriate to ensure the
reliability, clarity, and accuracy of
interpretation of mammograms and standards for
appropriate radiation dose;
(B) standards that require use of
radiological equipment specifically designed
for mammography, including radiologic standards
and standards for other equipment and materials
used in conjunction with such equipment;
(C) a requirement that personnel who
perform mammography--
(i)(I) be licensed by a State to
perform radiological procedures; or
(II) be certified as qualified to
perform radiological procedures by an
organization described in paragraph
(2)(A); and
(ii) during the 2-year period
beginning October 1, 1994, meet
training standards for personnel who
perform mammography or meet experience
requirements which shall at a minimum
include 1 year of experience in the
performance of mammography; and
(iii) upon the expiration of such
2-year period meet minimum training
standards for personnel who perform
mammograms;
(D) a requirement that mammograms be
interpreted by a physician who is certified as
qualified to interpret radiological procedures,
including mammography--
(i)(I) by a board described in
paragraph (2)(B); or
(II) by a program that complies
with the standards described in
paragraph (2)(C); and
(ii) who meets training and
continuing medical education
requirements as established by the
Secretary;
(E) a requirement that individuals who
survey mammography facilities be medical
physicists--
(i) licensed or approved by a State
to perform such surveys, reviews, or
inspections for mammography facilities;
(ii) certified in diagnostic
radiological physics or certified as
qualified to perform such surveys by a
board as described in paragraph (2)(D);
or
(iii) in the first 5 years after
the date of the enactment of this
section, who meet other criteria
established by the Secretary which are
comparable to the criteria described in
clause (i) or (ii);
(F) a requirement that a medical physicist
who is qualified in mammography as described in
subparagraph (E) survey mammography equipment
and oversee quality assurance practices at each
facility;
(G) a requirement that--
(i) a facility that performs any
mammogram--
(I) except as provided in
subclause (II), maintain the
mammogram in the permanent
medical records of the patient
for a period of not less than 5
years, or not less than 10
years if no subsequent
mammograms of such patient are
performed at the facility, or
longer if mandated by State
law; and
(II) upon the request of or
on behalf of the patient,
transfer the mammogram to a
medical institution, to a
physician of the patient, or to
the patient directly; and
(ii)(I) a facility must assure the
preparation of a written report of the
results of any mammography examination
signed by the interpreting physician;
(II) such written report shall be
provided to the patient's physicians
(if any);
(III) if such a physician is not
available or if there is no such
physician, the written report shall be
sent directly to the patient; and
(IV) whether or not such a
physician is available or there is no
such physician, a summary of the
written report shall be sent directly
to the patient in terms easily
understood by a lay person; and
(H) standards relating to special
techniques for mammography of patients with
breast implants.
Subparagraph (G) shall not be construed to limit a
patient's access to the patient's medical records.
(2) Certification of personnel.--The Secretary
shall by regulation--
(A) specify organizations eligible to
certify individuals to perform radiological
procedures as required by paragraph (1)(C);
(B) specify boards eligible to certify
physicians to interpret radiological
procedures, including mammography, as required
by paragraph (1)(D);
(C) establish standards for a program to
certify physicians described in paragraph
(1)(D); and
(D) specify boards eligible to certify
medical physicists who are qualified to survey
mammography equipment and to oversee quality
assurance practices at mammography facilities.
(g) Inspections.--
(1) Annual inspections.--
(A) In general.--The Secretary may enter
and inspect facilities to determine compliance
with the certification requirements under
subsection (b) and the standards established
under subsection (f). The Secretary shall, if
feasible, delegate to a State or local agency
the authority to make such inspections.
(B) Identification.--The Secretary, or
State or local agency acting on behalf of the
Secretary, may conduct inspections only on
presenting identification to the owner,
operator, or agent in charge of the facility to
be inspected.
(C) Scope of inspection.--In conducting
inspections, the Secretary or State or local
agency acting on behalf of the Secretary--
(i) shall have access to all
equipment, materials, records, and
information that the Secretary or State
or local agency considers necessary to
determine whether the facility is being
operated in accordance with this
section; and
(ii) may copy, or require the
facility to submit to the Secretary or
the State or local agency, any of the
materials, records, or information.
(D) Qualifications of inspectors.--
Qualified individuals, as determined by the
Secretary, shall conduct all inspections. The
Secretary may request that a State or local
agency acting on behalf of the Secretary
designate a qualified officer or employee to
conduct the inspections, or designate a
qualified Federal officer or employee to
conduct inspections. The Secretary shall
establish minimum qualifications and
appropriate training for inspectors and
criteria for certification of inspectors in
order to inspect facilities for compliance with
subsection (f).
(E) Frequency.--The Secretary or State or
local agency acting on behalf of the Secretary
shall conduct inspections under this paragraph
of each facility not less often than annually,
subject to paragraph (6).
(F) Records and annual reports.--The
Secretary or a State or local agency acting on
behalf of the Secretary which is responsible
for inspecting mammography facilities shall
maintain records of annual inspections required
under this paragraph for a period as prescribed
by the Secretary. Such a State or local agency
shall annually prepare and submit to the
Secretary a report concerning the inspections
carried out under this paragraph. Such reports
shall include a description of the facilities
inspected and the results of such inspections.
(2) Inspection of accredited facilities.--The
Secretary shall inspect annually a sufficient number of
the facilities accredited by an accreditation body to
provide the Secretary with a reasonable estimate of the
performance of such body.
(3) Inspection of facilities inspected by state or
local agencies.--The Secretary shall inspect annually
facilities inspected by State or local agencies acting
on behalf of the Secretary to assure a reasonable
performance by such State or local agencies.
(4) Timing.--The Secretary, or State or local
agency, may conduct inspections under paragraphs (1),
(2), and (3), during regular business hours or at a
mutually agreeable time and after providing such notice
as the Secretary may prescribe, except that the
Secretary may waive such requirements if the continued
performance of mammography at such facility threatens
the public health.
(5) Limited reinspection.--Nothing in this section
limits the authority of the Secretary to conduct
limited reinspections of facilities found not to be in
compliance with this section.
(6) Demonstration program.--
(A) In general.--The Secretary may
establish a demonstration program under which
inspections under paragraph (1) of selected
facilities are conducted less frequently by the
Secretary (or as applicable, by State or local
agencies acting on behalf of the Secretary)
than the interval specified in subparagraph (E)
of such paragraph.
(B) Requirements.--Any demonstration
program under subparagraph (A) shall be carried
out in accordance with the following:
(i) The program may not be
implemented before April 1, 2001.
Preparations for the program may be
carried out prior to such date.
(ii) In carrying out the program,
the Secretary may not select a facility
for inclusion in the program unless the
facility is substantially free of
incidents of noncompliance with the
standards under subsection (f ). The
Secretary may at any time provide that
a facility will no longer be included
in the program.
(iii) The number of facilities
selected for inclusion in the program
shall be sufficient to provide a
statistically significant sample,
subject to compliance with clause (ii).
(iv) Facilities that are selected
for inclusion in the program shall be
inspected at such intervals as the
Secretary determines will reasonably
ensure that the facilities are
maintaining compliance with such
standards.
(h) Sanctions.--
(1) In general.--In order to promote voluntary
compliance with this section, the Secretary may, in
lieu of taking the actions authorized by subsection
(i), impose one or more of the following sanctions:
(A) Directed plans of correction which
afford a facility an opportunity to correct
violations in a timely manner.
(B) Payment for the cost of onsite
monitoring.
(2) Patient information.--If the Secretary
determines that the quality of mammography performed by
a facility (whether or not certified pursuant to
subsection (c)) was so inconsistent with the quality
standards established pursuant to subsection (f ) as to
present a significant risk to individual or public
health, the Secretary may require such facility to
notify patients who received mammograms at such
facility, and their referring physicians, of the
deficiencies presenting such risk, the potential harm
resulting, appropriate remedial measures, and such
other relevant information as the Secretary may
require.
(3) Civil money penalties.--The Secretary may
assess civil money penalties in an amount not to exceed
$10,000 for--
(A) failure to obtain a certificate as
required by subsection (b),
(B) each failure by a facility to
substantially comply with, or each day on which
a facility fails to substantially comply with,
the standards established under subsection (f)
or the requirements described in subclauses (I)
through (III) of subsection (d)(1)(B)(ii),
(C) each failure to notify a patient of
risk as required by the Secretary pursuant to
paragraph (2), and
(D) each violation, or for each aiding and
abetting in a violation of, any provision of,
or regulation promulgated under, this section
by an owner, operator, or any employee of a
facility required to have a certificate.
(4) Procedures.--The Secretary shall develop and
implement procedures with respect to when and how each
of the sanctions is to be imposed under paragraphs (1)
through (3). Such procedures shall provide for notice
to the owner or operator of the facility and a
reasonable opportunity for the owner or operator to
respond to the proposed sanctions and appropriate
procedures for appealing determinations relating to the
imposition of sanctions.
(i) Suspension and Revocation.--
(1) In general.--The certificate of a facility
issued under subsection (c) may be suspended or revoked
if the Secretary finds, after providing, except as
provided in paragraph (2), reasonable notice and an
opportunity for a hearing to the owner or operator of
the facility, that the owner, operator, or any employee
of the facility--
(A) has been guilty of misrepresentation in
obtaining the certificate;
(B) has failed to comply with the
requirements of subsection (d)(1)(B)(ii)(III)
or the standards established by the Secretary
under subsection (f);
(C) has failed to comply with reasonable
requests of the Secretary (or of an
accreditation body approved pursuant to
subsection (e)) for any record, information,
report, or material that the Secretary (or such
accreditation body or State carrying out
certification program requirements pursuant to
subsection (q)) concludes is necessary to
determine the continued eligibility of the
facility for a certificate or continued
compliance with the standards established under
subsection (f);
(D) has refused a reasonable request of the
Secretary, any Federal officer or employee duly
designated by the Secretary, or any State or
local officer or employee duly designated by
the State or local agency, for permission to
inspect the facility or the operations and
pertinent records of the facility in accordance
with subsection (g);
(E) has violated or aided and abetted in
the violation of any provision of, or
regulation promulgated under, this section; or
(F) has failed to comply with a sanction
imposed under subsection (h).
(2) Action before a hearing.--
(A) In general.--The Secretary may suspend
the certificate of the facility before holding
a hearing required by paragraph (1) if the
Secretary has reason to believe that the
circumstance of the case will support one or
more of the findings described in paragraph (1)
and that--
(i) the failure or violation was
intentional; or
(ii) the failure or violation
presents a serious risk to human
health.
(B) Hearing.--If the Secretary suspends a
certificate under subparagraph (A), the
Secretary shall provide an opportunity for a
hearing to the owner or operator of the
facility not later than 60 days from the
effective date of the suspension. The
suspension shall remain in effect until the
decision of the Secretary made after the
hearing.
(3) Ineligibility to own or operate facilities
after revocation.--If the Secretary revokes the
certificate of a facility on the basis of an act
described in paragraph (1), no person who owned or
operated the facility at the time of the act may,
within 2 years of the revocation of the certificate,
own or operate a facility that requires a certificate
under this section.
(j) Injunctions.--If the Secretary determines that--
(1) continuation of any activity related to the
provision of mammography by a facility would constitute
a serious risk to human health, the Secretary may bring
suit in the district court of the United States for the
district in which the facility is situated to enjoin
continuation of the activity; and
(2) a facility is operating without a certificate
as required by subsection (b), the Secretary may bring
suit in the district court of the United States for the
district in which the facility is situated to enjoin
the operation of the facility.
Upon a proper showing, the district court shall grant a
temporary injunction or restraining order against continuation
of the activity or against operation of a facility, as the case
may be, without requiring the Secretary to post a bond, pending
issuance of a final order under this subsection.
(k) Judicial Review.--
(1) Petition.--If the Secretary imposes a sanction
on a facility under subsection (h) or suspends or
revokes the certificate of a facility under subsection
(i), the owner or operator of the facility may, not
later than 60 days after the date the action of the
Secretary becomes final, file a petition with the
United States court of appeals for the circuit in which
the facility is situated for judicial review of the
action. As soon as practicable after receipt of the
petition, the clerk of the court shall transmit a copy
of the petition to the Secretary or other officer
designated by the Secretary. As soon as practicable
after receipt of the copy, the Secretary shall file in
the court the record on which the action of the
Secretary is based, as provided in section 2112 of
title 28, United States Code.
(2) Additional evidence.--If the petitioner applies
to the court for leave to adduce additional evidence,
and shows to the satisfaction of the court that the
additional evidence is material and that there were
reasonable grounds for the failure to adduce such
evidence in the proceeding before the Secretary, the
court may order the additional evidence (and evidence
in rebuttal of the additional evidence) to be taken
before the Secretary, and to be adduced upon the
hearing in such manner and upon such terms and
conditions as the court may determine to be proper. The
Secretary may modify the findings of the Secretary as
to the facts, or make new findings, by reason of the
additional evidence so taken, and the Secretary shall
file the modified or new findings, and the
recommendations of the Secretary, if any, for the
modification or setting aside of the original action of
the Secretary with the return of the additional
evidence.
(3) Judgment of court.--Upon the filing of the
petition referred to in paragraph (1), the court shall
have jurisdiction to affirm the action, or to set the
action aside in whole or in part, temporarily or
permanently. The findings of the Secretary as to the
facts, if supported by substantial evidence, shall be
conclusive.
(4) Finality of judgment.--The judgment of the
court affirming or setting aside, in whole or in part,
any action of the Secretary shall be final, subject to
review by the Supreme Court of the United States upon
certiorari or certification, as provided in section
1254 of title 28, United States Code.
(l) Information.--
(1) In general.--Not later than October 1, 1996,
and annually thereafter, the Secretary shall compile
and make available to physicians and the general public
information that the Secretary determines is useful in
evaluating the performance of facilities, including a
list of facilities--
(A) that have been convicted under Federal
or State laws relating to fraud and abuse,
false billings, or kickbacks;
(B) that have been subject to sanctions
under subsection (h), together with a statement
of the reasons for the sanctions;
(C) that have had certificates revoked or
suspended under subsection (i), together with a
statement of the reasons for the revocation or
suspension;
(D) against which the Secretary has taken
action under subsection (j), together with a
statement of the reasons for the action;
(E) whose accreditation has been revoked,
together with a statement of the reasons of the
revocation;
(F) against which a State has taken adverse
action; and
(G) that meets such other measures of
performance as the Secretary may develop.
(2) Date.--The information to be compiled under
paragraph (1) shall be information for the calendar
year preceding the date the information is to be made
available to the public.
(3) Explanatory information.--The information to be
compiled under paragraph (1) shall be accompanied by
such explanatory information as may be appropriate to
assist in the interpretation of the information
compiled under such paragraph.
(m) State Laws.--Nothing in this section shall be construed
to limit the authority of any State to enact and enforce laws
relating to the matters covered by this section that are at
least as stringent as this section or the regulations issued
under this section.
(n) National Advisory Committee.--
(1) Establishment.--In carrying out this section,
the Secretary shall establish an advisory committee to
be known as the National Mammography Quality Assurance
Advisory Committee (hereafter in this subsection
referred to as the ``Advisory Committee'').
(2) Composition.--The Advisory Committee shall be
composed of not fewer than 13, nor more than 19
individuals, who are not officers or employees of the
Federal Government. The Secretary shall make
appointments to the Advisory Committee from among--
(A) physicians,
(B) practitioners, and
(C) other health professionals,
whose clinical practice, research specialization, or
professional expertise include a significant focus on
mammography. The Secretary shall appoint at least 4
individuals from among national breast cancer or
consumer health organizations with expertise in
mammography, at least 2 industry representatives with
expertise in mammography equipment, and at least 2
practicing physicians who provide mammography services.
(3) Functions and duties.--The Advisory Committee
shall--
(A) advise the Secretary on appropriate
quality standards and regulations for
mammography facilities;
(B) advise the Secretary on appropriate
standards and regulations for accreditation
bodies;
(C) advise the Secretary in the development
of regulations with respect to sanctions;
(D) assist in developing procedures for
monitoring compliance with standards under
subsection (f);
(E) make recommendations and assist in the
establishment of a mechanism to investigate
consumer complaints;
(F) report on new developments concerning
breast imaging that should be considered in the
oversight of mammography facilities;
(G) determine whether there exists a
shortage of mammography facilities in rural and
health professional shortage areas and
determine the effects of personnel or other
requirements of subsection (f) on access to the
services of such facilities in such areas;
(H) determine whether there will exist a
sufficient number of medical physicists after
October 1, 1999, to assure compliance with the
requirements of subsection (f)(1)(E);
(I) determine the costs and benefits of
compliance with the requirements of this
section (including the requirements of
regulations promulgated under this section);
and
(J) perform other activities that the
Secretary may require.
The Advisory Committee shall report the findings made
under subparagraphs (G) and (I) to the Secretary and
the Congress no later than October 1, 1993.
(4) Meetings.--The Advisory Committee shall meet
not less than quarterly for the first 3 years of the
program and thereafter, at least annually.
(5) Chairperson.--The Secretary shall appoint a
chairperson of the Advisory Committee.
(o) Consultations.--In carrying out this section, the
Secretary shall consult with appropriate Federal agencies
within the Department of Health and Human Services for the
purposes of developing standards, regulations, evaluations, and
procedures for compliance and oversight.
(p) Breast Cancer Screening Surveillance Research Grants.--
(1) Research.--
(A) Grants.--The Secretary shall award
grants to such entities as the Secretary may
determine to be appropriate to establish
surveillance systems in selected geographic
areas to provide data to evaluate the
functioning and effectiveness of breast cancer
screening programs in the United States,
including assessments of participation rates in
screening mammography, diagnostic procedures,
incidence of breast cancer, mode of detection
(mammography screening or other methods),
outcome and follow up information, and such
related epidemiologic analyses that may improve
early cancer detection and contribute to
reduction in breast cancer mortality. Grants
may be awarded for further research on breast
cancer surveillance systems upon the
Secretary's review of the evaluation of the
program.
(B) Use of funds.--Grants awarded under
subparagraph (A) may be used--
(i) to study--
(I) methods to link
mammography and clinical breast
examination records with
population-based cancer
registry data;
(II) methods to provide
diagnostic outcome data, or
facilitate the communication of
diagnostic outcome data, to
radiology facilities for
purposes of evaluating patterns
of mammography interpretation;
and
(III) mechanisms for
limiting access and maintaining
confidentiality of all stored
data; and
(ii) to conduct pilot testing of
the methods and mechanisms described in
subclauses (I), (II), and (III) of
clause (i) on a limited basis.
(C) Grant application.--To be eligible to
receive funds under this paragraph, an entity
shall submit an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may require.
(D) Report.--A recipient of a grant under
this paragraph shall submit a report to the
Secretary containing the results of the study
and testing conducted under clauses (i) and
(ii) of subparagraph (B), along with
recommendations for methods of establishing a
breast cancer screening surveillance system.
(2) Establishment.--The Secretary shall establish a
breast cancer screening surveillance system based on
the recommendations contained in the report described
in paragraph (1)(D).
(3) Standards and procedures.--The Secretary shall
establish standards and procedures for the operation of
the breast cancer screening surveillance system,
including procedures to maintain confidentiality of
patient records.
(4) Information.--The Secretary shall recruit
facilities to provide to the breast cancer screening
surveillance system relevant data that could help in
the research of the causes, characteristics, and
prevalence of, and potential treatments for, breast
cancer and benign breast conditions, if the information
may be disclosed under section 552 of title 5, United
States Code.
(q) State Program.--
(1) In general.--The Secretary may, upon
application, authorize a State--
(A) to carry out, subject to paragraph (2),
the certification program requirements under
subsections (b), (c), (d), (g)(1), (h), (i),
and (j) (including the requirements under
regulations promulgated pursuant to such
subsections), and
(B) to implement the standards established
by the Secretary under subsection (f),
with respect to mammography facilities operating within
the State.
(2) Approval.-- The Secretary may approve an
application under paragraph (1) if the Secretary
determines that--
(A) the State has enacted laws and issued
regulations relating to mammography facilities
which are the requirements of this section
(including the requirements under regulations
promulgated pursuant to such subsections), and
(B) the State has provided satisfactory
assurances that the State--
(i) has the legal authority and
qualified personnel necessary to
enforce the requirements of and the
regulations promulgated pursuant to
this section (including the
requirements under regulations
promulgated pursuant to such
subsections),
(ii) will devote adequate funds to
the administration and enforcement of
such requirements, and
(iii) will provide the Secretary
with such information and reports as
the Secretary may require.
(3) Authority of Secretary.--In a State with an
approved application--
(A) the Secretary shall carry out the
Secretary's functions under subsections (e) and
(f);
(B) the Secretary may take action under
subsections (h), (i), and (j); and
(C) the Secretary shall conduct oversight
functions under subsections (g)(2) and (g)(3).
(4) Withdrawal of approval.--
(A) In general.--The Secretary may, after
providing notice and opportunity for corrective
action, withdraw the approval of a State's
authority under paragraph (1) if the Secretary
determines that the State does not meet the
requirements of such paragraph. The Secretary
shall promulgate regulations for the
implementation of this subparagraph.
(B) Effect of withdrawal.--If the Secretary
withdraws the approval of a State under
subparagraph (A), the certificate of any
facility certified by the State shall continue
in effect until the expiration of a reasonable
period, as determined by the Secretary, for
such facility to obtain certification by the
Secretary.
(r) Funding.--
(1) Fees.--
(A) In general.--The Secretary shall, in
accordance with this paragraph assess and
collect fees from persons described in
subsection (d)(1)(A) (other than persons who
are governmental entities, as determined by the
Secretary) to cover the costs of inspections
conducted under subsection (g)(1) by the
Secretary or a State acting under a delegation
under subparagraph (A) of such subsection. Fees
may be assessed and collected under this
paragraph only in such manner as would result
in an aggregate amount of fees collected during
any fiscal year which equals the aggregate
amount of costs for such fiscal year for
inspections of facilities of such persons under
subsection (g)(1). A person's liability for
fees shall be reasonably based on the
proportion of the inspection costs which relate
to such person.
(B) Deposit and appropriations.--
(i) Deposit and availability.--Fees
collected under subparagraph (A) shall
be deposited as an offsetting
collection to the appropriations for
the Department of Health and Human
Services as provided in appropriation
Acts and shall remain available without
fiscal year limitation.
(ii) Appropriations.--Fees
collected under subparagraph (A) shall
be collected and available only to the
extent provided in advance in
appropriation Acts.
(2) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this
section--
(A) to award research grants under
subsection (p), such sums as may be necessary
for each of the fiscal years 1993 through 2007;
and
(B) for the Secretary to carry out other
activities which are not supported by fees
authorized and collected under paragraph (1),
such sums as may be necessary for fiscal years
1993 through 2007.
Part G--Quarantine and Inspection
control of communicable diseases
Sec. 361. [264] (a) The Surgeon General, with the approval
of the Secretary is authorized to make and enforce such
regulations as in his judgment are necessary to prevent the
introduction, transmission, or spread of communicable diseases
from foreign countries into the States or possessions, or from
one State or possession into any other State or possession. For
purposes of carrying out and enforcing such regulations, the
Surgeon General may provide for such inspection, fumigation,
disinfection, sanitation, pest extermination, destruction of
animals or articles found to be so infected or contaminated as
to be sources of dangerous infection to human beings, and other
measures, as in his judgment may be necessary.
(b) Regulations prescribed under this section shall not
provide for the apprehension, detention, or conditional release
of individuals except for the purpose of preventing the
introduction, transmission, or spread of such communicable
diseases as may be specified from time to time in Executive
orders of the President upon the recommendation of the
Secretary, in consultation with the Surgeon General, \1\.
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\1\ The comma is so in law. See the amendment made by section
142(a)(1) of Public Law 107-188 (116 Stat. 626).
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(c) Except as provided in subsection (d), regulations
prescribed under this section, insofar as they provide for the
apprehension, detention, examination, or conditional release of
individuals, shall be applicable only to individuals coming
into a State or possession from a foreign country or a
possession.
(d)(1) Regulations prescribed under this section may
provide for the apprehension and examination of any individual
reasonably believed to be infected with a communicable disease
in a qualifying stage and (A) to be moving or about to move
from a State to another State; or (B) to be a probable source
of infection to individuals who, while infected with such
disease in a qualifying stage, will be moving from a State to
another State. Such regulations may provide that if upon
examination any such individual is found to be infected, he may
be detained for such time and in such manner as may be
reasonably necessary. For purposes of this subsection, the term
``State'' includes, in addition to the several States, only the
District of Columbia.
(2) For purposes of this subsection, the term ``qualifying
stage'', with respect to a communicable disease, means that
such disease--
(A) is in a communicable stage; or
(B) is in a precommunicable stage, if the disease
would be likely to cause a public health emergency if
transmitted to other individuals.
(e) Nothing in this section or section 363, or the
regulations promulgated under such sections, may be construed
as superseding any provision under State law (including
regulations and including provisions established by political
subdivisions of States), except to the extent that such a
provision conflicts with an exercise of Federal authority under
this section or section 363.
suspension of entries and imports from designated places
Sec. 362. [265] Whenever the Surgeon General determines
that by reason of the existence of any communicable disease in
a foreign country there is serious danger of the introduction
of such disease into the United States, and that this danger is
so increased by the introduction of persons or property from
such country that a suspension of the right to introduce such
persons and property is required in the interest of the public
health, the Surgeon General, in accordance with regulations
approved by the President, shall have the power to prohibit, in
whole or in part, the introduction of persons and property from
such countries or places as he shall designate in order to
avert such danger, and for such period of time as he may deem
necessary for such purpose.
special powers in time of war
Sec. 363. \1\ [266] To protect the military and naval
forces and war workers of the United States, in time of war,
against any communicable disease specified in Executive orders
as provided in subsection (b) of section 361, the Secretary, in
consultation with the Surgeon General, is authorized to provide
by regulations for the apprehension and examination, in time of
war, of any individual reasonably believed (1) to be infected
with such disease and (2) to be a probable source of infection
to members of the armed forces of the United States or to
individuals engaged in the production or transportation of
arms, munitions, ships, food, clothing, or other supplies for
the armed forces. Such regulations may provide that if upon
examination any such individual is found to be so infected, he
may be detained for such time and in such manner as may be
reasonably necessary.
---------------------------------------------------------------------------
\1\ Under section 3 of Public Law 239, 80th Congress, the date of
July 25, 1947, is deemed, for purposes of this section, to be the date
of termination of ``any state of war heretofore declared by the
Congress''.
---------------------------------------------------------------------------
quarantine stations
Sec. 364. [267] (a) Except as provided in title II of the
Act of June 15, 1917, as amended (U.S.C., 1940 edition, title
50, secs. 191-194), \2\ the Surgeon General shall control,
direct, and manage all United States quarantine stations,
grounds, and anchorages, designate their boundaries, and
designate the quarantine officers to be in charge thereof. With
the approval of the President he shall from time to time select
suitable sites for and establish such additional stations,
grounds, and anchorages in the States and possessions of the
United States as in his judgment are necessary to prevent the
introduction of communicable diseases into the States and
possessions of the United States.
---------------------------------------------------------------------------
\2\ Now codified to sections 191, 192, 194, and 195 of title 50,
United States Code.
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(b) The Surgeon General shall establish the hours during
which quarantine service shall be performed at each quarantine
station, and, upon application by any interested party, may
establish quarantine inspection during the twenty-four hours of
the day, or any fraction thereof, at such quarantine stations
as, in his opinion, require such extended service. He may
restrict the performance of quarantine inspection to hours of
daylight for such arriving vessels as cannot, in his opinion,
be satisfactorily inspected during hours of darkness. No vessel
shall be required to undergo quarantine inspection during the
hours of darkness, unless the quarantine officer at such
quarantine station shall deem an immediate inspection necessary
to protect the public health. Uniformity shall not be required
in the hours during which quarantine inspection may be obtained
at the various ports of the United States.
(c) The Surgeon General shall fix a reasonable rate of
extra compensation for overtime services of employees of the
United States Public Health Service, Foreign Quarantine
Division, performing overtime duties including the operation of
vessels, in connection with the inspection or quarantine
treatment of persons (passengers and crews), conveyances, or
goods arriving by land, water, or air in the United States or
any place subject to the jurisdiction thereof, hereinafter
referred to as ``employees of the Public Health Service'', when
required to be on duty between the hours of 6 o'clock
postmeridian and 6 o'clock antemeridian (or between the hours
of 7 o'clock postmeridian and 7 o'clock antemeridian at
stations which have a declared workday of from 7 o'clock
antemeridian to 7 o'clock postmeridian), or on Sundays or
holidays, such rate, in lieu of compensation under any other
provision of law, to be fixed at two times the basic hourly
rate for each hour that the overtime extends beyond 6 o'clock
(or 7 o'clock as the case may be) postmeridian, and two times
the basic hourly rate for each overtime hour worked on Sundays
or holidays. As used in this subsection, the term ``basic
hourly rate'' shall mean the regular basic rate of pay which is
applicable to such employees for work performed within their
regular scheduled tour of duty.
(d)(1) The said extra compensation shall be paid to the
United States by the owner, agent, consignee, operator, or
master or other person in charge of any conveyance, for whom,
at his request, services as described in this subsection
(hereinafter referred to as overtime service) are performed. If
such employees have been ordered to report for duty and have so
reported, and the requested services are not performed by
reason of circumstances beyond the control of the employees
concerned, such extra compensation shall be paid on the same
basis as though the overtime services had actually been
performed during the period between the time the employees were
ordered to report for duty and did so report, and the time they
were notified that their services would not be required, and in
any case as though their services had continued for not less
than one hour. The Surgeon General with the approval of the
Secretary of Health, Education, and Welfare may prescribe
regulations requiring the owner, agent, consignee, operator, or
master or other person for whom the overtime services are
performed to file a bond in such amounts and containing such
conditions and with such sureties, or in lieu of a bond, to
deposit money or obligations of the United States in such
amount, as will assure the payment of charges under this
subsection, which bond or deposit may cover one or more
transactions or all transactions during a specified period:
Provided, That no charges shall be made for services performed
in connection with the inspection of (1) persons arriving by
international highways, ferries, bridges, or tunnels, or the
conveyances in which they arrive, or (2) persons arriving by
aircraft or railroad trains, the operations of which are
covered by published schedules, or the aircraft or trains in
which they arrive, or (3) persons arriving by vessels operated
between Canadian ports and ports on Puget Sound or operated on
the Great Lakes and connecting waterways, the operations of
which are covered by published schedules, or the vessels in
which they arrive.
(2) Moneys collected under this subsection shall be
deposited in the Treasury of the United States to the credit of
the appropriation charged with the expense of the services, and
the appropriations so credited shall be available for the
payment of such compensation to the said employees for services
so rendered.
certain duties of consular and other officers
Sec. 365. [268] (a) Any consular or medical officer of the
United States, designated for such purpose by the Secretary,
shall make reports to the Surgeon General, on such forms and at
such intervals as the Surgeon General may prescribe, of the
health conditions at the port or place at which such officer is
stationed.
(b) It shall be the duty of the customs officers and of
Coast Guard officers to aid in the enforcement of quarantine
rules and regulations; but no additional compensation, except
actual and necessary traveling expenses, shall be allowed any
such officer by reason of such services.
bills of health
Sec. 366. [269] (a) Except as otherwise prescribed in
regulations, any vessel at any foreign port or place clearing
or departing for any port or place in a State or possession
shall be required to obtain from the consular officer of the
United States or from the Public Health Service officer, or
other medical officer of the United States designated by the
Surgeon General, at the port or place of departure, a bill of
health in duplicate, in the form prescribed by the Surgeon
General. The President, from time to time, shall specify the
ports at which a medical officer shall be stationed for this
purpose. Such bill of health shall set forth the sanitary
history and condition of said vessel, and shall state that it
has in all respects complied with the regulations prescribed
pursuant to subsection (c). Before granting such duplicate bill
of health, such consular or medical officer shall be satisfied
that the matters and things therein stated are true. The
consular officer shall be entitled to demand and receive the
fees for bills of health and such fees shall be established by
regulation.
(b) Original bills of health shall be delivered to the
collectors of customs at the port of entry. Duplicate copies of
such bills of health shall be delivered at the time of
inspection to quarantine officers at such port. The bills of
health herein prescribed shall be considered as part of the
ship's papers, and when duly certified to by the proper
consular or other officer of the United States, over his
official signature and seal, shall be accepted as evidence of
the statements therein contained in any court of the United
States.
(c) The Surgeon General shall from time to time prescribe
regulations, applicable to vessels referred to in subsection
(a) of this section for the purpose of preventing the
introduction into the States or possessions of the United
States of any communicable disease by securing the best
sanitary condition of such vessels, their cargoes, passengers,
and crews. Such regulations shall be observed by such vessels
prior to departure, during the course of the voyage, and also
during inspection, disinfection, or other quarantine procedure
upon arrival at any United States quarantine station.
(d) The provisions of subsections (a) and (b) of this
section shall not apply to vessels plying between such foreign
ports on or near the frontiers of the United States and ports
of the United States as are designated by treaty.
(e) It shall be unlawful for any vessel to enter any port
in any State or possession of the United States to discharge
its cargo, or land its passengers, except upon a certificate of
the quarantine officer that regulations prescribed under
subsection (c) have in all respects been complied with by such
officer, the vessel, and its master. The master of every such
vessel shall deliver such certificate to the collector of
customs at the port of entry, together with the original bill
of health and other papers of the vessel. The certificate
required by this subsection shall be procurable from the
quarantine officer, upon arrival of the vessel at the
quarantine station and satisfactory inspection thereof, at any
time within which quarantine services are performed at such
station.
civil air navigation and civil aircraft
Sec. 367. [270] The Surgeon General is authorized to
provide by regulations for the application to air navigation
and aircraft of any of the provisions of sections 364, 365, and
366 and regulations prescribed thereunder (including penalties
and forfeitures for violations of such sections and
regulations), to such extent and upon such conditions as he
deems necessary for the safeguarding of the public health.
penalties
Sec. 368. [271] (a) Any person who violates any regulation
prescribed under section 361, 362, or 363, or any provision of
section 366 or any regulation prescribed thereunder, or who
enters or departs from the limits of any quarantine station,
ground, or anchorage in disregard of quarantine rules and
regulations or without permission of the quarantine officer in
charge, shall be punished by a fine of not more than $1,000 or
by imprisonment for not more than one year, or both.
(b) Any vessel which violates section 366, or any
regulations thereunder or under section 364, or which enters
within or departs from the limits of any quarantine station,
ground, or anchorage in disregard of the quarantine rules and
regulations or without permission of the officer in charge,
shall forfeit to the United States not more than $5,000, the
amount to be determined by the court, which shall be a lien on
such vessel, to be recovered by proceedings in the proper
district court of the United States. In all such proceedings
the United States attorney shall appear on behalf of the United
States; and all such proceedings shall be conducted in
accordance with the rules and laws governing cases of seizure
of vessels for violation of the revenue laws of the United
States.
(c) With the approval of the Secretary, the Surgeon General
may, upon application therefor, remit or mitigate any
forfeiture provided for under subsection (b) of this section,
and he shall have authority to ascertain the facts upon all
such applications.
administration of oaths
Sec. 369. [272] Medical officers of the United States, when
performing duties as quarantine officers at any port or place
within the United States, are authorized to take declarations
and administer oaths in matters pertaining to the
administration of the quarantine laws and regulations of the
United States.
Part H--Organ Transplants \1\
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\1\ Section 301 of the National Organ Transplant Act (Public Law
98-507; 42 U.S.C. 274e) provides:
Sec. 301. (a) It shall be unlawful for any person to knowingly
acquire, receive, or otherwise transfer any human organ for valuable
consideration for use in human transplantaion if the transfer affects
interstate commerce.
(b) Any person who violates subsection (a) shall be fined not more
than $50,000 or imprisoned not more than five years, or both.
(c) For purposes of subsection (a):
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(1) The term ``human organ'' means the human (including
fetal) kidney, liver, heart, lung, pancreas, bone marrow,
cornea, eye, bone, and skin or any subpart thereof and any
other human organ (or any subpart thereof, including that
derived from a fetus) specified by the Secretary of Health and
Human Services by regulation.
(2) The term ``valuable consideration'' does not include the
reasonable payments associated with the removal,
transportation, implantation, processing, preservation, quality
control, and storage of a human organ or the expenses of
travel, housing, and lost wages incurred by the donor of a
human organ in connection with the donation of the organ.
(3) The term ``interstate commerce'' has the meaning
prescribed for it by section 201(b) of the Federal Food, Drug
and Cosmetic Act.
organ procurement organizations
Sec. 371. [273] (a)(1) The Secretary may make grants for
the planning of qualified organ procurement organizations
described in subsection (b).
(2) The Secretary may make grants for the establishment,
initial operation, consolidation, and expansion of qualified
organ procurement organizations described in subsection (b).
(b)(1) \2\ A qualified organ procurement organization for
which grants may be made under subsection (a) is an
organization which, as determined by the Secretary, will carry
out the functions described in paragraph (2) \3\ and--
---------------------------------------------------------------------------
\2\ So in law. Subparagraphs (D) and (E) have the same text, and
there are two subparagraphs (H). This results from the same set of
amendments to section 371(b)(1) being enacted twice. The first set of
amendments was made by section 701(c) of Public Law 106-505 (114 Stat.
2347). These amendments redesignated subparagraphs (D) through (G) as
subparagraphs (E) through (H), respectively, and then added a new
subparagraph (D). The second set was made by section 219(b) of the
Departments of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 2001 (as enacted into law by
section 1(a)(1) of Public Law 106-554; 114 Stat. 2763A-29). Per the
second set of amendments, the subparagraph (D) added by the first set
was redesignated as (E), and the same text was again added as a
subparagraph (D). Per the second set, subparagraphs (F) and (G), as
redesignated by the first set, were redesignated as (G) and (H), which
resulted in there being two subparagraphs (H).
\3\ So in law. Probably should be ``paragraph (3)''.
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(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as
specified by the Secretary) necessary to assure the
fiscal stability of the organization,
(C) has an agreement with the Secretary to be
reimbursed under title XVIII of the Social Security Act
for the procurement of kidneys,
(D) notwithstanding any other provision of law, has
met the other requirements of this section and has been
certified or recertified by the Secretary within the
previous 4-year period as meeting the performance
standards to be a qualified organ procurement
organization through a process that either--
(i) granted certification or
recertification within such 4-year period with
such certification or recertification in effect
as of January 1, 2000, and remaining in effect
through the earlier of--
(I) January 1, 2002; or
(II) the completion of
recertification under the requirements
of clause (ii); or
(ii) is defined through regulations that
are promulgated by the Secretary by not later
than January 1, 2002, that--
(I) require recertifications of
qualified organ procurement
organizations not more frequently than
once every 4 years;
(II) rely on outcome and process
performance measures that are based on
empirical evidence, obtained through
reasonable efforts, of organ donor
potential and other related factors in
each service area of qualified organ
procurement organizations;
(III) use multiple outcome measures
as part of the certification process;
and
(IV) provide for a qualified organ
procurement organization to appeal a
decertification to the Secretary on
substantive and procedural grounds;
(E) notwithstanding any other provision of law, has
met the other requirements of this section and has been
certified or recertified by the Secretary within the
previous 4-year period as meeting the performance
standards to be a qualified organ procurement
organization through a process that either--
(i) granted certification or
recertification within such 4-year period with
such certification or recertification in effect
as of January 1, 2000, and remaining in effect
through the earlier of--
(I) January 1, 2002; or
(II) the completion of
recertification under the requirements
of clause (ii); or
(ii) is defined through regulations that
are promulgated by the Secretary by not later
than January 1, 2002, that--
(I) require recertifications of
qualified organ procurement
organizations not more frequently than
once every 4 years;
(II) rely on outcome and process
performance measures that are based on
empirical evidence, obtained through
reasonable efforts, of organ donor
potential and other related factors in
each service area of qualified organ
procurement organizations;
(III) use multiple outcome measures
as part of the certification process;
and
(IV) provide for a qualified organ
procurement organization to appeal a
decertification to the Secretary on
substantive and procedural grounds; \1\
---------------------------------------------------------------------------
\1\ So in law. Subparagraphs (D) and (E) have semicolons at the end
of organizational units, rather than commas.
---------------------------------------------------------------------------
(F) has procedures to obtain payment for non-renal
organs provided to transplant centers,
(G) has a defined service area that is of
sufficient size to assure maximum effectiveness in the
procurement and equitable distribution of organs, and
that either includes an entire metropolitan statistical
area (as specified by the Director of the Office of
Management and Budget) or does not include any part of
the area,
(H) has a director and such other staff, including
the organ donation coordinators and organ procurement
specialists necessary to effectively obtain organs from
donors in its service area, and
(H) has a board of directors or an advisory board
which--
(i) is composed of--
(I) members who represent hospital
administrators, intensive care or
emergency room personnel, tissue banks,
and voluntary health associations in
its service area,
(II) members who represent the
public residing in such area,
(III) a physician with knowledge,
experience, or skill in the field of
histocompatability \1\ or an individual
with a doctorate degree in a biological
science with knowledge, experience, or
skill in the field of
histocompatibility,
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``histocompatibility''.
---------------------------------------------------------------------------
(IV) a physician with knowledge or
skill in the field of neurology, and
(V) from each transplant center in
its service area which has arrangements
described in paragraph (2) \2\(G) with
the organization, a member who is a
surgeon who has practicing privileges
in such center and who performs organ
transplant surgery,
(ii) has the authority to recommend
policies for the procurement of organs and the
other functions described in paragraph (2) \2\,
and
---------------------------------------------------------------------------
\2\ So in law. Probably should be paragraph (3).
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(iii) has no authority over any other
activity of the organization.
(2)(A) Not later than 90 days after the date of the
enactment of this paragraph, \3\ the Secretary shall publish in
the Federal Register a notice of proposed rulemaking to
establish criteria for determining whether an entity meets the
requirement established in paragraph (1)(E).
---------------------------------------------------------------------------
\3\ Enacted November 16, 1990. See section 201(d) of Public Law
101-616.
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(B) Not later than 1 year after the date of enactment of
this paragraph, \3\ the Secretary shall publish in the Federal
Register a final rule to establish the criteria described in
subparagraph (A).
(3) An organ procurement organization shall--
(A) have effective agreements, to identify
potential organ donors, with a substantial majority of
the hospitals and other health care entities in its
service area which have facilities for organ donations,
(B) conduct and participate in systematic efforts,
including professional education, to acquire all usable
organs from potential donors,
(C) arrange for the acquisition and preservation of
donated organs and provide quality standards for the
acquisition of organs which are consistent with the
standards adopted by the Organ Procurement and
Transplantation Network under section 372(b)(2)(E),
including arranging for testing with respect to
preventing the acquisition of organs that are infected
with the etiologic agent for acquired immune deficiency
syndrome,
(D) arrange for the appropriate tissue typing of
donated organs,
(E) have a system to allocate donated organs
equitably among transplant patients according to
established medical criteria,
(F) provide or arrange for the transportation of
donated organs to transplant centers,
(G) have arrangements to coordinate its activities
with transplant centers in its service area,
(H) participate in the Organ Procurement
Transplantation Network established under section 372,
(I) have arrangements to cooperate with tissue
banks for the retrieval, processing, preservation,
storage, and distribution of tissues as may be
appropriate to assure that all usable tissues are
obtained from potential donors,
(J) evaluate annually the effectiveness of the
organization in acquiring potentially available organs,
and
(K) assist hospitals in establishing and
implementing protocols for making routine inquiries
about organ donations by potential donors.
(c) Pancreata procured by an organ procurement organization
and used for islet cell transplantation or research shall be
counted for purposes of certification or recertification under
subsection (b).
SEC. 371A. [273A] NATIONAL LIVING DONOR MECHANISMS.
The Secretary may establish and maintain mechanisms to
evaluate the long-term effects associated with living organ
donations by individuals who have served as living donors.
organ procurement and transplantation network
Sec. 372. [274] (a) The Secretary shall by contract provide
for the establishment and operation of an Organ Procurement and
Transplantation Network which meets the requirements of
subsection (b). The amount provided under such contract in any
fiscal year may not exceed $7,000,000. Funds for such contracts
shall be made available from funds available to the Public
Health Service from appropriations for fiscal years beginning
after fiscal year 1984.
(b)(1) The Organ Procurement and Transplantation Network
shall carry out the functions described in paragraph (2) and
shall--
(A) be a private nonprofit entity that has an
expertise in organ procurement and transplantation, and
(B) have a board of directors--
(i) that includes representatives of organ
procurement organizations (including
organizations that have received grants under
section 371), transplant centers, voluntary
health associations, and the general public;
and
(ii) that shall establish an executive
committee and other committees, whose
chairpersons shall be selected to ensure
continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network
shall--
(A) establish in one location or through regional
centers--
(i) a national list of individuals who need
organs, and
(ii) a national system, through the use of
computers and in accordance with established
medical criteria, to match organs and
individuals included in the list, especially
individuals whose immune system makes it
difficult for them to receive organs,
(B) establish membership criteria and medical
criteria for allocating organs and provide to members
of the public an opportunity to comment with respect to
such criteria,
(C) maintain a twenty-four-hour telephone service
to facilitate matching organs with individuals included
in the list,
(D) assist organ procurement organizations in the
nationwide distribution of organs equitably among
transplant patients,
(E) adopt and use standards of quality for the
acquisition and transportation of donated organs,
including standards for preventing the acquisition of
organs that are infected with the etiologic agent for
acquired immune deficiency syndrome,
(F) prepare and distribute, on a regionalized basis
(and, to the extent practicable, among regions or on a
national basis), samples of blood sera from individuals
who are included on the list and whose immune system
makes it difficult for them to receive organs, in order
to facilitate matching the compatibility of such
individuals with organ donors,
(G) coordinate, as appropriate, the transportation
of organs from organ procurement organizations to
transplant centers,
(H) provide information to physicians and other
health professionals regarding organ donation,
(I) collect, analyze, and publish data concerning
organ donation and transplants,
(J) carry out studies and demonstration projects
for the purpose of improving procedures for organ
procurement and allocation,
(K) work actively to increase the supply of donated
organs,
(L) submit to the Secretary an annual report
containing information on the comparative costs and
patient outcomes at each transplant center affiliated
with the organ procurement and transplantation network,
(M) \1\ recognize the differences in health
and in organ transplantation issues between
children and adults throughout the system and
adopt criteria, polices, and procedures that
address the unique health care needs of
children,
---------------------------------------------------------------------------
\1\ Indentation is so in law. See section 2101(a)(3) of Public Law
106-310 (114 Stat. 1156).
---------------------------------------------------------------------------
(N) \1\ carry out studies and demonstration
projects for the purpose of improving
procedures for organ donation procurement and
allocation, including but not limited to
projects to examine and attempt to increase
transplantation among populations with special
needs, including children and individuals who
are members of racial or ethnic minority
groups, and among populations with limited
access to transportation, and
(O) \1\ provide that for purposes of this
paragraph, the term ``children'' refers to
individuals who are under the age of 18.
---------------------------------------------------------------------------
\1\ See footnote for subparagraph (M).
---------------------------------------------------------------------------
(c) The Secretary shall establish procedures for--
(1) receiving from interested persons critical
comments relating to the manner in which the Organ
Procurement and Transplantation Network is carrying out
the duties of the Network under subsection (b); and
(2) the consideration by the Secretary of such
critical comments.
scientific registry
Sec. 373. [274a] The Secretary shall, by grant or contract,
develop and maintain a scientific registry of the recipients of
organ transplants. The registry shall include such information
respecting patients and transplant procedures as the Secretary
deems necessary to an ongoing evaluation of the scientific and
clinical status of organ transplantation. The Secretary shall
prepare for inclusion in the report under section 376 an
analysis of information derived from the registry.
general provisions respecting grants and contracts
Sec. 374. [274b] (a) No grant may be made under this part
or contract entered into under section 372 or 373 unless an
application therefor has been submitted to, and approved by,
the Secretary. Such an application shall be in such form and
shall be submitted in such manner as the Secretary shall by
regulation prescribe.
(b)(1) A grant for planning under section 371(a)(1) may be
made for one year with respect to any organ procurement
organization and may not exceed $100,000.
(2) Grants under section 371(a)(2) may be made for two
years. No such grant may exceed $500,000 for any year and no
organ procurement organization may receive more than $800,000
for initial operation or expansion.
(3) Grants or contracts under section 371(a)(3) may be made
for not more than 3 years.
(c)(1) The Secretary shall determine the amount of a grant
or contract made under section 371 or 373. Payments under such
grants and contracts may be made in advance on the basis of
estimates or by the way of reimbursement, with necessary
adjustments on account of underpayments or overpayments, and in
such installments and on such terms and conditions as the
Secretary finds necessary to carry out the purposes of such
grants and contracts.
(2)(A) Each recipient of a grant or contract under section
371 or 373 shall keep such records as the Secretary shall
prescribe, including records which fully disclose the amount
and disposition by such recipient of the proceeds of such grant
or contract, the total cost of the undertaking in connection
with which such grant or contract was made, and the amount of
that portion of the cost of the undertaking supplied by other
sources, and such other records as will facilitate an effective
audit.
(B) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall
have access for the purpose of audit and examination to any
books, documents, papers, and records of the recipient of a
grant or contract under section 371 or 373 that are pertinent
to such grant or contract.
(d) For purposes of this part:
(1) The term ``transplant center'' means a health
care facility in which transplants of organs are
performed.
(2) The term ``organ'' means the human kidney,
liver, heart, lung, pancreas, and any other human organ
(other than corneas and eyes) specified by the
Secretary by regulation and for purposes of section
373, such term includes bone marrow.
administration
Sec. 375. [274c] The Secretary shall designate and maintain
an identifiable administrative unit in the Public Health
Service to--
(1) administer this part and coordinate with the
organ procurement activities under title XVIII of the
Social Security Act,
(2) conduct a program of public information to
inform the public of the need for organ donations,
(3) provide technical assistance to organ
procurement organizations, the Organ Procurement and
Transplantation Network established under section 372,
and other entities in the health care system involved
in organ donations, procurement, and transplants, and
(4) provide information--
(i) \1\ to patients, their families, and
their physicians about transplantation; and
---------------------------------------------------------------------------
\1\ Clauses (i) and (ii) probably should be redesignated as
subparagraphs (A) and (B). See section 204(b)(2) of Public Law 101-616
(104 Stat. 3285).
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(ii) \1\ to patients and their families
about the resources available nationally and in
each State, and the comparative costs and
patient outcomes at each transplant center
affiliated with the organ procurement and
transplantation network, in order to assist the
patients and families with the costs associated
with transplantation.
report
Sec. 376. [274d] Not later than February 10 of 1991 and of
each second year thereafter, the Secretary shall publish, and
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate. \2\ a report on the scientific and clinical
status of organ transplantation. The Secretary shall consult
with the Director of the National Institutes of Health and the
Commissioner of the Food and Drug Administration in the
preparation of the report.
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\2\ So in law. There probably should be a comma after ``Senate''
rather than a period. See section 205 of Public Law 101-616.
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SEC. 377. [274F] REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EXPENSES
INCURRED TOWARD LIVING ORGAN DONATION.
(a) In General.--The Secretary may award grants to States,
transplant centers, qualified organ procurement organizations
under section 371, or other public or private entities for the
purpose of--
(1) providing for the reimbursement of travel and
subsistence expenses incurred by individuals toward
making living donations of their organs (in this
section referred to as ``donating individuals''); and
(2) providing for the reimbursement of such
incidental nonmedical expenses that are so incurred as
the Secretary determines by regulation to be
appropriate.
(b) Preference.--The Secretary shall, in carrying out
subsection (a), give preference to those individuals that the
Secretary determines are more likely to be otherwise unable to
meet such expenses.
(c) Certain Circumstances.--The Secretary may, in carrying
out subsection (a), consider--
(1) the term ``donating individuals'' as including
individuals who in good faith incur qualifying expenses
toward the intended donation of an organ but with
respect to whom, for such reasons as the Secretary
determines to be appropriate, no donation of the organ
occurs; and
(2) the term ``qualifying expenses'' as including
the expenses of having relatives or other individuals,
not to exceed 2, accompany or assist the donating
individual for purposes of subsection (a) (subject to
making payment for only those types of expenses that
are paid for a donating individual).
(d) Relationship to Payments Under Other Programs.--An
award may be made under subsection (a) only if the applicant
involved agrees that the award will not be expended to pay the
qualifying expenses of a donating individual to the extent that
payment has been made, or can reasonably be expected to be
made, with respect to such expenses--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program;
(2) by an entity that provides health services on a
prepaid basis; or
(3) by the recipient of the organ.
(e) Definitions.--For purposes of this section:
(1) The term ``donating individuals'' has the
meaning indicated for such term in subsection (a)(1),
subject to subsection (c)(1).
(2) The term ``qualifying expenses'' means the
expenses authorized for purposes of subsection (a),
subject to subsection (c)(2).
(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there is authorized to be
appropriated $5,000,000 for each of the fiscal years 2005
through 2009.
SEC. 377A. [274F-1] PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS.
(a) Organ Donation Public Awareness Program.--The Secretary
shall, directly or through grants or contracts, establish a
public education program in cooperation with existing national
public awareness campaigns to increase awareness about organ
donation and the need to provide for an adequate rate of such
donations.
(b) Studies and Demonstrations.--The Secretary may make
peer-reviewed grants to, or enter into peer-reviewed contracts
with, public and nonprofit private entities for the purpose of
carrying out studies and demonstration projects to increase
organ donation and recovery rates, including living donation.
(c) Grants to States.--
(1) In general.--The Secretary may make grants to
States for the purpose of assisting States in carrying
out organ donor awareness, public education, and
outreach activities and programs designed to increase
the number of organ donors within the State, including
living donors.
(2) Eligibility.--To be eligible to receive a grant
under this subsection, a State shall--
(A) submit an application to the Department
in the form prescribed;
(B) establish yearly benchmarks for
improvement in organ donation rates in the
State; and
(C) report to the Secretary on an annual
basis a description and assessment of the
State's use of funds received under this
subsection, accompanied by an assessment of
initiatives for potential replication in other
States.
(3) Use of funds.--Funds received under this
subsection may be used by the State, or in partnership
with other public agencies or private sector
institutions, for education and awareness efforts,
information dissemination, activities pertaining to the
State donor registry, and other innovative donation
specific initiatives, including living donation.
(d) Educational Activities.--The Secretary, in coordination
with the Organ Procurement and Transplantation Network and
other appropriate organizations, shall support the development
and dissemination of educational materials to inform health
care professionals and other appropriate professionals in
issues surrounding organ, tissue, and eye donation including
evidence-based proven methods to approach patients and their
families, cultural sensitivities, and other relevant issues.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $15,000,000 for fiscal year 2005, and such sums as
may be necessary for each of the fiscal years 2006 through
2009. Such authorization of appropriations is in addition to
any other authorizations of appropriations that are available
for such purpose.
SEC. 377B. [274F-2] GRANTS REGARDING HOSPITAL ORGAN DONATION
COORDINATORS.
(a) Authority.--
(1) In general.--The Secretary may award grants to
qualified organ procurement organizations and hospitals
under section 371 to establish programs coordinating
organ donation activities of eligible hospitals and
qualified organ procurement organizations under section
371. Such activities shall be coordinated to increase
the rate of organ donations for such hospitals.
(2) Eligible hospital.--For purposes of this
section, the term ``eligible hospital'' means a
hospital that performs significant trauma care, or a
hospital or consortium of hospitals that serves a
population base of not fewer than 200,000 individuals.
(b) Administration of Coordination Program.--A condition
for the receipt of a grant under subsection (a) is that the
applicant involved agree that the program under such subsection
will be carried out jointly--
(1) by representatives from the eligible hospital
and the qualified organ procurement organization with
respect to which the grant is made; and
(2) by such other entities as the representatives
referred to in paragraph (1) may designate.
(c) Requirements.--Each entity receiving a grant under
subsection (a) shall--
(1) establish joint organ procurement organization
and hospital designated leadership responsibility and
accountability for the project;
(2) develop mutually agreed upon overall project
performance goals and outcome measures, including
interim outcome targets; and
(3) collaboratively design and implement an
appropriate data collection process to provide ongoing
feedback to hospital and organ procurement organization
leadership on project progress and results.
(d) Rule of Construction.--Nothing in this section shall be
construed to interfere with regulations in force on the date of
enactment of the Organ Donation and Recovery Improvement Act.
(e) Evaluations.--Within 3 years after the award of grants
under this section, the Secretary shall ensure an evaluation of
programs carried out pursuant to subsection (a) in order to
determine the extent to which the programs have increased the
rate of organ donation for the eligible hospitals involved.
(f) Matching Requirement.--The Secretary may not award a
grant to a qualifying organ donation entity under this section
unless such entity agrees that, with respect to costs to be
incurred by the entity in carrying out activities for which the
grant was awarded, the entity shall contribute (directly or
through donations from public or private entities) non-Federal
contributions in cash or in kind, in an amount equal to not
less than 30 percent of the amount of the grant awarded to such
entity.
(g) Funding.--For the purpose of carrying out this section,
there are authorized to be appropriated $3,000,000 for fiscal
year 2005, and such sums as may be necessary for each of fiscal
years 2006 through 2009.
SEC. 377C. [274F-3] STUDIES RELATING TO ORGAN DONATION AND THE
RECOVERY, PRESERVATION, AND TRANSPORTATION OF
ORGANS.
(a) Development of Supportive Information.--The Secretary,
acting through the Director of the Agency for Healthcare
Research and Quality, shall develop scientific evidence in
support of efforts to increase organ donation and improve the
recovery, preservation, and transportation of organs.
(b) Activities.--In carrying out subsection (a), the
Secretary shall--
(1) conduct or support evaluation research to
determine whether interventions, technologies, or other
activities improve the effectiveness, efficiency, or
quality of existing organ donation practice;
(2) undertake or support periodic reviews of the
scientific literature to assist efforts of professional
societies to ensure that the clinical practice
guidelines that they develop reflect the latest
scientific findings;
(3) ensure that scientific evidence of the research
and other activities undertaken under this section is
readily accessible by the organ procurement workforce;
and
(4) work in coordination with the appropriate
professional societies as well as the Organ Procurement
and Transplantation Network and other organ procurement
and transplantation organizations to develop evidence
and promote the adoption of such proven practices.
(c) Research and Dissemination.--The Secretary, acting
through the Director of the Agency for Healthcare Research and
Quality, as appropriate, shall provide support for research and
dissemination of findings, to--
(1) develop a uniform clinical vocabulary for organ
recovery;
(2) apply information technology and
telecommunications to support the clinical operations
of organ procurement organizations;
(3) enhance the skill levels of the organ
procurement workforce in undertaking quality
improvement activities; and
(4) assess specific organ recovery, preservation,
and transportation technologies.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 2005, and such sums as
may be necessary for each of fiscal years 2006 through 2009.
SEC. 377D. [274F-4] REPORT RELATING TO ORGAN DONATION AND THE RECOVERY,
PRESERVATION, AND TRANSPORTATION OF ORGANS.
(a) In General.--Not later than December 31, 2005, and
every 2 years thereafter, the Secretary shall report to the
appropriate committees of Congress on the activities of the
Department carried out pursuant to this part, including an
evaluation describing the extent to which the activities have
affected the rate of organ donation and recovery.
(b) Requirements.--To the extent practicable, each report
submitted under subsection (a) shall--
(1) evaluate the effectiveness of activities,
identify effective activities, and disseminate such
findings with respect to organ donation and recovery;
(2) assess organ donation and recovery activities
that are recently completed, ongoing, or planned; and
(3) evaluate progress on the implementation of the
plan required under subsection (c)(5).
(c) Initial Report Requirements.--The initial report under
subsection (a) shall include the following:
(1) An evaluation of the organ donation practices
of organ procurement organizations, States, other
countries, and other appropriate organizations
including an examination across all populations,
including those with low organ donation rates, of--
(A) existing barriers to organ donation;
and
(B) the most effective donation and
recovery practices.
(2) An evaluation of living donation practices and
procedures. Such evaluation shall include an assessment
of issues relating to informed consent and the health
risks associated with living donation (including
possible reduction of long-term effects).
(3) An evaluation of--
(A) federally supported or conducted organ
donation efforts and policies, as well as
federally supported or conducted basic,
clinical, and health services research
(including research on preservation techniques
and organ rejection and compatibility); and
(B) the coordination of such efforts across
relevant agencies within the Department and
throughout the Federal Government.
(4) An evaluation of the costs and benefits of
State donor registries, including the status of
existing State donor registries, the effect of State
donor registries on organ donation rates, issues
relating to consent, and recommendations regarding
improving the effectiveness of State donor registries
in increasing overall organ donation rates.
(5) A plan to improve federally supported or
conducted organ donation and recovery activities,
including, when appropriate, the establishment of
baselines and benchmarks to measure overall outcomes of
these programs. Such plan shall provide for the ongoing
coordination of federally supported or conducted organ
donation and research activities.
SEC. 378. [274G] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated $8,000,000 for fiscal year 1991,
and such sums as may be necessary for each of the fiscal years
1992 and 1993.
PART I--C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM
SEC. 379. [274K] NATIONAL PROGRAM.
(a) Establishment.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall by one or more contracts establish and
maintain a C.W. Bill Young Cell Transplantation Program
(referred to in this section as the ``Program''), successor to
the National Bone Marrow Donor Registry, that has the purpose
of increasing the number of transplants for recipients suitably
matched to biologically unrelated donors of bone marrow and
cord blood, and that meets the requirements of this section.
The Secretary may award a separate contract to perform each of
the major functions of the Program described in paragraphs (1)
and (2) of subsection (d) if deemed necessary by the Secretary
to operate an effective and efficient system that is in the
best interest of patients. The Secretary shall conduct a
separate competition for the initial establishment of the cord
blood functions of the Program. The Program shall be under the
general supervision of the Secretary. The Secretary shall
establish an Advisory Council to advise, assist, consult with,
and make recommendations to the Secretary on matters related to
the activities carried out by the Program. The members of the
Advisory Council shall be appointed in accordance with the
following:
(1) Each member of the Advisory Council shall serve
for a term of 2 years, and each such member may serve
as many as 3 consecutive 2-year terms, except that--
(A) such limitations shall not apply to the
Chair of the Advisory Council (or the Chair-
elect) or to the member of the Advisory Council
who most recently served as the Chair; and
(B) one additional consecutive 2-year term
may be served by any member of the Advisory
Council who has no employment, governance, or
financial affiliation with any donor center,
recruitment organization, transplant center, or
cord blood bank.
(2) A member of the Advisory Council may continue
to serve after the expiration of the term of such
member until a successor is appointed.
(3) In order to ensure the continuity of the
Advisory Council, the Advisory Council shall be
appointed so that each year the terms of approximately
one-third of the members of the Advisory Council
expire.
(4) The membership of the Advisory Council--
(A) shall include as voting members a
balanced number of representatives including
representatives of marrow donor centers and
marrow transplant centers, representatives of
cord blood banks and participating birthing
hospitals, recipients of a bone marrow
transplant, recipients of a cord blood
transplant, persons who require such
transplants, family members of such a recipient
or family members of a patient who has
requested the assistance of the Program in
searching for an unrelated donor of bone marrow
or cord blood, persons with expertise in bone
marrow and cord blood transplantation, persons
with expertise in typing, matching, and
transplant outcome data analysis, persons with
expertise in the social sciences, basic
scientists with expertise in the biology of
adult stem cells, and members of the general
public; and
(B) shall include as nonvoting members
representatives from the Department of Defense
Marrow Donor Recruitment and Research Program
operated by the Department of the Navy, the
Division of Transplantation of the Health
Resources and Services Administration, the Food
and Drug Administration, and the National
Institutes of Health.
(5) Members of the Advisory Council shall be chosen
so as to ensure objectivity and balance and reduce the
potential for conflicts of interest. The Secretary
shall establish bylaws and procedures--
(A) to prohibit any member of the Advisory
Council who has an employment, governance, or
financial affiliation with a donor center,
recruitment organization, transplant center, or
cord blood bank from participating in any
decision that materially affects the center,
recruitment organization, transplant center, or
cord blood bank; and
(B) to limit the number of members of the
Advisory Council with any such affiliation.
(6) The Secretary, acting through the Advisory
Council, shall submit to the Congress--
(A) an annual report on the activities
carried out under this section; and
(B) not later than 6 months after the date
of the enactment of the Stem Cell Therapeutic
and Research Act of 2005, a report of
recommendations on the scientific factors
necessary to define a cord blood unit as a
high-quality unit.
(b) Accreditation.--The Secretary shall, through a public
process, recognize one or more accreditation entities for the
accreditation of cord blood banks.
(c) Informed Consent.--The Secretary shall, through a
public process, examine issues of informed consent, including--
(1) the appropriate timing of such consent; and
(2) the information provided to the maternal donor
regarding all of her medically appropriate cord blood
options.
Based on such examination, the Secretary shall require that the
standards used by the accreditation entities recognized under
subsection (b) ensure that a cord blood unit is acquired with
the informed consent of the maternal donor.
(d) Functions.-- \1\
---------------------------------------------------------------------------
\1\ Section 5 of Public Law 105-196 (112 Stat. 636) provides as
follows:
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``SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
---------------------------------------------------------------------------
``(a) In General.--During the period indicated pursuant to
subsection (b), the Comptroller General of the United States shall
conduct a study of the National Bone Marrow Donor Registry under
section 379 of the Public Health Service Act for purposes of making
determinations of the following:
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``(1) The extent to which, relative to the effective date of
this Act, such Registry has increased the representation of
racial and ethnic minority groups (including persons of mixed
ancestry) among potential donors of bone marrow who are
enrolled with the Registry, and whether the extent of increase
results in a level of representation that meets the standard
established in subsection (c)(1)(A) of such section 379 (as
added by section 2(c) of this Act).
``(2) The extent to which patients in need of a transplant of
bone marrow from a biologically unrelated donor, and the
physicians of such patients, have been utilizing the Registry
in the search for such a donor.
``(3) The number of such patients for whom the Registry began
a preliminary search but for whom the full search process was
not completed, and the reasons underlying such circumstances.
``(4) The extent to which the plan required in section
2(b)(2) of this Act (relating to the relationship between the
Registry and donor centers) has been implemented.
``(5) The extent to which the Registry, donor centers, donor
registries, collection centers, transplant centers, and other
appropriate entities have been complying with the standards,
criteria, and procedures under subsection (e) of such section
379 (as redesignated by section 2(c) of this Act).
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``(b) Report.--A report describing the findings of the study under
subsection (a) shall be submitted to the Congress not later than
October 1, 2001. The report may not be submitted before January 1,
2001.''.
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(1) Bone marrow functions.--With respect to bone
marrow, the Program shall--
(A) operate a system for identifying,
matching, and facilitating the distribution of
bone marrow that is suitably matched to
candidate patients;
(B) consistent with paragraph (3), permit
transplant physicians, other appropriate health
care professionals, and patients to search by
means of electronic access all available bone
marrow donors listed in the Program;
(C) carry out a program for the recruitment
of bone marrow donors in accordance with
subsection (e), including with respect to
increasing the representation of racial and
ethnic minority groups (including persons of
mixed ancestry) in the enrollment of the
Program;
(D) maintain and expand medical contingency
response capabilities, in coordination with
Federal programs, to prepare for and respond
effectively to biological, chemical, or
radiological attacks, and other public health
emergencies that can damage marrow, so that the
capability of supporting patients with marrow
damage from disease can be used to support
casualties with marrow damage;
(E) carry out informational and educational
activities in accordance with subsection (e);
(F) at least annually update information to
account for changes in the status of
individuals as potential donors of bone marrow;
(G) provide for a system of patient
advocacy through the office established under
subsection (h);
(H) provide case management services for
any potential donor of bone marrow to whom the
Program has provided a notice that the
potential donor may be suitably matched to a
particular patient through the office
established under subsection (h);
(I) with respect to searches for unrelated
donors of bone marrow that are conducted
through the system under subparagraph (A),
collect, analyze, and publish data in a
standardized electronic format on the number
and percentage of patients at each of the
various stages of the search process, including
data regarding the furthest stage reached, the
number and percentage of patients who are
unable to complete the search process, and the
reasons underlying such circumstances;
(J) support studies and demonstration and
outreach projects for the purpose of increasing
the number of individuals who are willing to be
marrow donors to ensure a genetically diverse
donor pool; and
(K) facilitate research with the
appropriate Federal agencies to improve the
availability, efficiency, safety, and cost of
transplants from unrelated donors and the
effectiveness of Program operations.
(2) Cord blood functions.--With respect to cord
blood, the Program shall--
(A) operate a system for identifying,
matching, and facilitating the distribution of
donated cord blood units that are suitably
matched to candidate patients and meet all
applicable Federal and State regulations
(including informed consent and Food and Drug
Administration regulations) from a qualified
cord blood bank;
(B) consistent with paragraph (3), allow
transplant physicians, other appropriate health
care professionals, and patients to search by
means of electronic access all available cord
blood units made available through the Program;
(C) allow transplant physicians and other
appropriate health care professionals to
reserve, as defined by the Secretary, a cord
blood unit for transplantation;
(D) support studies and demonstration and
outreach projects for the purpose of increasing
cord blood donation to ensure a genetically
diverse collection of cord blood units;
(E) provide for a system of patient
advocacy through the office established under
subsection (h);
(F) coordinate with the qualified cord
blood banks to support informational and
educational activities in accordance with
subsection (g);
(G) maintain and expand medical contingency
response capabilities, in coordination with
Federal programs, to prepare for and respond
effectively to biological, chemical, or
radiological attacks, and other public health
emergencies that can damage marrow, so that the
capability of supporting patients with marrow
damage from disease can be used to support
casualties with marrow damage; and
(H) with respect to the system under
subparagraph (A), collect, analyze, and publish
data in a standardized electronic format, as
required by the Secretary, on the number and
percentage of patients at each of the various
stages of the search process, including data
regarding the furthest stage reached, the
number and percentage of patients who are
unable to complete the search process, and the
reasons underlying such circumstances.
(3) Single point of access; standard data.--
(A) Single point of access.--The Secretary
shall ensure that health care professionals and
patients are able to search electronically for
and facilitate access to, in the manner and to
the extent defined by the Secretary and
consistent with the functions described in
paragraphs (1)(A) and (2)(A), cells from bone
marrow donors and cord blood units through a
single point of access.
(B) Standard data.--The Secretary shall
require all recipients of contracts under this
section to make available a standard dataset
for purposes of subparagraph (A) in a
standardized electronic format that enables
transplant physicians to compare among and
between bone marrow donors and cord blood units
to ensure the best possible match for the
patient.
(4) Definition.--The term ``qualified cord blood
bank'' means a cord blood bank that--
(A) has obtained all applicable Federal and
State licenses, certifications, registrations
(including pursuant to the regulations of the
Food and Drug Administration), and other
authorizations required to operate and maintain
a cord blood bank;
(B) has implemented donor screening, cord
blood collection practices, and processing
methods intended to protect the health and
safety of donors and transplant recipients to
improve transplant outcomes, including with
respect to the transmission of potentially
harmful infections and other diseases;
(C) is accredited by an accreditation
entity recognized by the Secretary under
subsection (b);
(D) has established a system of strict
confidentiality to protect the identity and
privacy of patients and donors in accordance
with existing Federal and State law;
(E) has established a system for
encouraging donation by a genetically diverse
group of donors; and
(F) has established a system to
confidentially maintain linkage between a cord
blood unit and a maternal donor.
(e) Bone Marrow Recruitment; Priorities; Information and
Education.--
(1) Recruitment; priorities.--The Program shall
carry out activities for the recruitment of bone marrow
donors. Such recruitment program shall identify
populations that are underrepresented among potential
donors enrolled with the Program. In the case of
populations that are identified under the preceding
sentence:
(A) The Program shall give priority to
carrying out activities under this part to
increase representation for such populations in
order to enable a member of such a population,
to the extent practicable, to have a
probability of finding a suitable unrelated
donor that is comparable to the probability
that an individual who is not a member of an
underrepresented population would have.
(B) The Program shall consider racial and
ethnic minority groups (including persons of
mixed ancestry) to be populations that have
been identified for purposes of this paragraph,
and shall carry out subparagraph (A) with
respect to such populations.
(2) Information and education regarding
recruitment; testing and enrollment.--
(A) In general.--The Program shall carry
out informational and educational activities,
in coordination with organ donation public
awareness campaigns operated through the
Department of Health and Human Services, for
purposes of recruiting individuals to serve as
donors of bone marrow, and shall test and
enroll with the Program potential bone marrow
donors. Such information and educational
activities shall include the following:
(i) Making information available to
the general public, including
information describing the needs of
patients with respect to donors of bone
marrow.
(ii) Educating and providing
information to individuals who are
willing to serve as potential bone
marrow donors.
(iii) Training individuals in
requesting individuals to serve as
potential bone marrow donors.
(B) Priorities.--In carrying out
informational and educational activities under
subparagraph (A), the Program shall give
priority to recruiting individuals to serve as
donors of bone marrow for populations that are
identified under paragraph (1).
(3) Transplantation as treatment option.--In
addition to activities regarding recruitment, the
recruitment program under paragraph (1) shall provide
information to physicians, other health care
professionals, and the public regarding bone marrow
transplants from unrelated donors as a treatment
option.
(4) Implementation of subsection.--The requirements
of this subsection shall be carried out by the entity
that has been awarded a contract by the Secretary under
subsection (a) to carry out the functions described in
subsection (d)(1).
(f) Bone Marrow Criteria, Standards, and Procedures.--The
Secretary shall enforce, for participating entities, including
the Program, individual marrow donor centers, marrow donor
registries, marrow collection centers, and marrow transplant
centers--
(1) quality standards and standards for tissue
typing, obtaining the informed consent of donors, and
providing patient advocacy;
(2) donor selection criteria, based on established
medical criteria, to protect both the donor and the
recipient and to prevent the transmission of
potentially harmful infectious diseases such as the
viruses that cause hepatitis and the etiologic agent
for Acquired Immune Deficiency Syndrome;
(3) procedures to ensure the proper collection and
transportation of the marrow;
(4) standards for the system for patient advocacy
operated under subsection (h), including standards
requiring the provision of appropriate information (at
the start of the search process and throughout the
process) to patients and their families and physicians;
(5) standards that--
(A) require the establishment of a system
of strict confidentiality of records relating
to the identity, address, HLA type, and
managing marrow donor center for marrow donors
and potential marrow donors; and
(B) prescribe the purposes for which the
records described in subparagraph (A) may be
disclosed, and the circumstances and extent of
the disclosure; and
(6) in the case of a marrow donor center or marrow
donor registry participating in the program, procedures
to ensure the establishment of a method for integrating
donor files, searches, and general procedures of the
center or registry with the Program.
(g) Cord Blood Recruitment; Priorities; Information and
Education.--
(1) Recruitment; priorities.--The Program shall
support activities, in cooperation with qualified cord
blood banks, for the recruitment of cord blood donors.
Such recruitment program shall identify populations
that are underrepresented among cord blood donors. In
the case of populations that are identified under the
preceding sentence:
(A) The Program shall give priority to
supporting activities under this part to
increase representation for such populations in
order to enable a member of such a population,
to the extent practicable, to have a
probability of finding a suitable cord blood
unit that is comparable to the probability that
an individual who is not a member of an
underrepresented population would have.
(B) The Program shall consider racial and
ethnic minority groups (including persons of
mixed ancestry) to be populations that have
been identified for purposes of this paragraph,
and shall support activities under subparagraph
(A) with respect to such populations.
(2) Information and education regarding
recruitment; testing and donation.--
(A) In general.--In carrying out the
recruitment program under paragraph (1), the
Program shall support informational and
educational activities in coordination with
qualified cord blood banks and organ donation
public awareness campaigns operated through the
Department of Health and Human Services, for
purposes of recruiting pregnant women to serve
as donors of cord blood. Such information and
educational activities shall include the
following:
(i) Making information available to
the general public, including
information describing the needs of
patients with respect to cord blood
units.
(ii) Educating and providing
information to pregnant women who are
willing to donate cord blood units.
(iii) Training individuals in
requesting pregnant women to serve as
cord blood donors.
(B) Priorities.--In carrying out
informational and educational activities under
subparagraph (A), the Program shall give
priority to supporting the recruitment of
pregnant women to serve as donors of cord blood
for populations that are identified under
paragraph (1).
(3) Transplantation as treatment option.--In
addition to activities regarding recruitment, the
recruitment program under paragraph (1) shall provide
information to physicians, other health care
professionals, and the public regarding cord blood
transplants from donors as a treatment option.
(4) Implementation of subsection.--The requirements
of this subsection shall be carried out by the entity
that has been awarded a contract by the Secretary under
subsection (a) to carry out the functions described in
subsection (d)(2).
(h) Patient Advocacy and Case Management for Bone Marrow
and Cord Blood.--
(1) In general.--The Secretary shall establish and
maintain, through a contract or other means determined
appropriate by the Secretary, an office of patient
advocacy (in this subsection referred to as the
``Office'').
(2) General functions.--The Office shall meet the
following requirements:
(A) The Office shall be headed by a
director.
(B) The Office shall be staffed by
individuals with expertise in bone marrow and
cord blood therapy covered under the Program.
(C) The Office shall operate a system for
patient advocacy, which shall be separate from
mechanisms for donor advocacy, and which shall
serve patients for whom the Program is
conducting, or has been requested to conduct, a
search for a bone marrow donor or cord blood
unit.
(D) In the case of such a patient, the
Office shall serve as an advocate for the
patient by directly providing to the patient
(or family members, physicians, or other
individuals acting on behalf of the patient)
individualized services with respect to
efficiently utilizing the system under
paragraphs (1) and (2) of subsection (d) to
conduct an ongoing search for a bone marrow
donor or cord blood unit and assist with
information regarding third party payor
matters.
(E) In carrying out subparagraph (D), the
Office shall monitor the system under
paragraphs (1) and (2) of subsection (d) to
determine whether the search needs of the
patient involved are being met, including with
respect to the following:
(i) Periodically providing to the
patient (or an individual acting on
behalf of the patient) information
regarding bone marrow donors or cord
blood units that are suitably matched
to the patient, and other information
regarding the progress being made in
the search.
(ii) Informing the patient (or such
other individual) if the search has
been interrupted or discontinued.
(iii) Identifying and resolving
problems in the search, to the extent
practicable.
(F) The Office shall ensure that the
following data are made available to patients:
(i) The resources available through
the Program.
(ii) A comparison of transplant
centers regarding search and other
costs that prior to transplantation are
charged to patients by transplant
centers.
(iii) The post-transplant outcomes
for individual transplant centers.
(iv) Information concerning issues
that patients may face after a
transplant.
(v) Such other information as the
Program determines to be appropriate.
(G) The Office shall conduct surveys of
patients (or family members, physicians, or
other individuals acting on behalf of patients)
to determine the extent of satisfaction with
the system for patient advocacy under this
subsection, and to identify ways in which the
system can be improved to best meet the needs
of patients.
(3) Case management.--
(A) In general.--In serving as an advocate
for a patient under paragraph (2), the Office
shall provide individualized case management
services directly to the patient (or family
members, physicians, or other individuals
acting on behalf of the patient), including--
(i) individualized case assessment;
and
(ii) the functions described in
paragraph (2)(D) (relating to progress
in the search process).
(B) Postsearch functions.--In addition to
the case management services described in
paragraph (1) for patients, the Office shall,
on behalf of patients who have completed the
search for a bone marrow donor or cord blood
unit, provide information and education on the
process of receiving a transplant, including
the post-transplant process.
(i) Comment Procedures.--The Secretary shall establish and
provide information to the public on procedures under which the
Secretary shall receive and consider comments from interested
persons relating to the manner in which the Program is carrying
out the duties of the Program. The Secretary may promulgate
regulations under this section.
(j) Consultation.--In developing policies affecting the
Program, the Secretary shall consult with the Advisory Council,
the Department of Defense Marrow Donor Recruitment and Research
Program operated by the Department of the Navy, and the board
of directors of each entity awarded a contract under this
section.
(k) Contracts.--
(1) Application.--To be eligible to enter into a
contract under this section, an entity shall submit to
the Secretary and obtain approval of an application at
such time, in such manner, and containing such
information as the Secretary shall by regulation
prescribe.
(2) Considerations.--In awarding contracts under
this section, the Secretary shall give consideration to
the continued safety of donors and patients and other
factors deemed appropriate by the Secretary.
(l) Eligibility.--Entities eligible to receive a contract
under this section shall include private nonprofit entities.
(m) Records.--
(1) Recordkeeping.--Each recipient of a contract or
subcontract under subsection (a) shall keep such
records as the Secretary shall prescribe, including
records that fully disclose the amount and disposition
by the recipient of the proceeds of the contract, the
total cost of the undertaking in connection with which
the contract was made, and the amount of the portion of
the cost of the undertaking supplied by other sources,
and such other records as will facilitate an effective
audit.
(2) Examination of records.--The Secretary and the
Comptroller General of the United States shall have
access to any books, documents, papers, and records of
the recipient of a contract or subcontract entered into
under this section that are pertinent to the contract,
for the purpose of conducting audits and examinations.
(n) Penalties for Disclosure.--Any person who discloses the
content of any record referred to in subsection (d)(4)(D) or
(f)(5)(A) without the prior written consent of the donor or
potential donor with respect to whom the record is maintained,
or in violation of the standards described in subsection
(f)(5)(B), shall be imprisoned for not more than 2 years or
fined in accordance with title 18, United States Code, or both.
SEC. 379A. [274L] STEM CELL THERAPEUTIC OUTCOMES DATABASE.
(a) Establishment.--The Secretary shall by contract
establish and maintain a scientific database of information
relating to patients who have been recipients of a stem cell
therapeutics product (including bone marrow, cord blood, or
other such product) from a donor.
(b) Information.--The outcomes database shall include
information in a standardized electronic format with respect to
patients described in subsection (a), diagnosis, transplant
procedures, results, long-term follow-up, and such other
information as the Secretary determines to be appropriate, to
conduct an ongoing evaluation of the scientific and clinical
status of transplantation involving recipients of a stem cell
therapeutics product from a donor.
(c) Annual Report on Patient Outcomes.--The Secretary shall
require the entity awarded a contract under this section to
submit to the Secretary an annual report concerning patient
outcomes with respect to each transplant center, based on data
collected and maintained by the entity pursuant to this
section.
(d) Publicly Available Data.--The outcomes database shall
make relevant scientific information not containing
individually identifiable information available to the public
in the form of summaries and data sets to encourage medical
research and to provide information to transplant programs,
physicians, patients, entities awarded a contract under section
379 donor registries, and cord blood banks.
SEC. 379A-1. [274L-1] DEFINITIONS.
In this part:
(1) The term ``Advisory Council'' means the
advisory council established by the Secretary under
section 379(a)(1).
(2) The term ``bone marrow'' means the cells found
in adult bone marrow and peripheral blood.
(3) The term ``outcomes database'' means the
database established by the Secretary under section
379A.
(4) The term ``Program'' means the C.W. Bill Young
Cell Transplantation Program established under section
379.
SEC. 379B. [274M] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated $34,000,000 for fiscal year 2006
and $38,000,000 for each of fiscal years 2007 through 2010.
Part J--Prevention and Control of Injuries
research
Sec. 391. [280b] (a) The Secretary, through the Director of
the Centers for Disease Control and Prevention, shall--
(1) conduct, and give assistance to public and
nonprofit private entities, scientific institutions,
and individuals engaged in the conduct of, research
relating to the causes, mechanisms, prevention,
diagnosis, treatment of injuries, and rehabilitation
from injuries;
(2) make grants to, or enter into cooperative
agreements or contracts with, public and nonprofit
private entities (including academic institutions,
hospitals, and laboratories) and individuals for the
conduct of such research; and
(3) make grants to, or enter into cooperative
agreements or contracts with, academic institutions for
the purpose of providing training on the causes,
mechanisms, prevention, diagnosis, treatment of
injuries, and rehabilitation from injuries.
(b) The Secretary, through the Director of the Centers for
Disease Control and Prevention, shall collect and disseminate,
through publications and other appropriate means, information
concerning the practical applications of research conducted or
assisted under subsection (a). In carrying out the preceding
sentence, the Secretary shall disseminate such information to
the public, including through elementary and secondary schools.
prevention and control activities
Sec. 392. [280b-1] (a) The Secretary, through the Director
of the Centers for Disease Control and Prevention, shall--
(1) assist States and political subdivisions of
States in activities for the prevention and control of
injuries; and
(2) encourage regional activities between States
designed to reduce injury rates.
(b) The Secretary, through the Director of the Centers for
Disease Control and Prevention, may--
(1) enter into agreements between the Service and
public and private community health agencies which
provide for cooperative planning of activities to deal
with problems relating to the prevention and control of
injuries;
(2) work in cooperation with other Federal
agencies, and with public and nonprofit private
entities, to promote activities regarding the
prevention and control of injuries; and
(3) make grants to States and, after consultation
with State health agencies, to other public or
nonprofit private entities for the purpose of carrying
out demonstration projects for the prevention and
control of injuries at sites that are not subject to
the Occupational Safety and Health Act of 1970,
including homes, elementary and secondary schools, and
public buildings.
interpersonal violence within families and among acquaintances
Sec. 393. [280b-1a] (a) With respect to activities that are
authorized in sections 391 and 392, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall carry out such activities with respect to
interpersonal violence within families and among acquaintances.
Activities authorized in the preceding sentence include the
following:
(1) Collecting data relating to the incidence of
such violence.
(2) Making grants to public and nonprofit private
entities for the evaluation of programs whose purpose
is to prevent such violence, including the evaluation
of demonstration projects under paragraph (6).
(3) Making grants to public and nonprofit private
entities for the conduct of research on identifying
effective strategies for preventing such violence.
(4) Providing to the public information and
education on such violence, including information and
education to increase awareness of the public health
consequences of such violence.
(5) Training health care providers as follows:
(A) To identify individuals whose medical
conditions or statements indicate that the
individuals are victims of such violence.
(B) To routinely determine, in examining
patients, whether the medical conditions or
statements of the patients so indicate.
(C) To refer individuals so identified to
entities that provide services regarding such
violence, including referrals for counseling,
housing, legal services, and services of
community organizations.
(6) Making grants to public and nonprofit private
entities for demonstration projects with respect to
such violence, including with respect to prevention.
(b) For purposes of this part, the term ``interpersonal
violence within families and among acquaintances'' includes
behavior commonly referred to as domestic violence, sexual
assault, spousal abuse, woman battering, partner abuse, elder
abuse, and acquaintance rape.check usc citations for
sections 393A and 393B which were renumbered by section 2(1)
and (2) of PL 110-206 deg.
SEC. 393A. [280B-1B] USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.
(a) Permitted Use.--The Secretary, acting through the
National Center for Injury Prevention and Control at the
Centers for Disease Control and Prevention, shall award
targeted grants to States to be used for rape prevention and
education programs conducted by rape crisis centers, State
sexual assault coalitions, and other public and private
nonprofit entities for--
(1) educational seminars;
(2) the operation of hotlines;
(3) training programs for professionals;
(4) the preparation of informational material;
(5) education and training programs for students
and campus personnel designed to reduce the incidence
of sexual assault at colleges and universities;
(6) education to increase awareness about drugs
used to facilitate rapes or sexual assaults; and
(7) other efforts to increase awareness of the
facts about, or to help prevent, sexual assault,
including efforts to increase awareness in underserved
communities and awareness among individuals with
disabilities (as defined in section 3 of the Americans
with Disabilities Act of 1990 (42 U.S.C. 12102)).
(b) Collection and Dissemination of Information on Sexual
Assault.--The Secretary shall, through the National Resource
Center on Sexual Assault established under the National Center
for Injury Prevention and Control at the Centers for Disease
Control and Prevention, provide resource information, policy,
training, and technical assistance to Federal, State, local,
and Indian tribal agencies, as well as to State sexual assault
coalitions and local sexual assault programs and to other
professionals and interested parties on issues relating to
sexual assault, including maintenance of a central resource
library in order to collect, prepare, analyze, and disseminate
information and statistics and analyses thereof relating to the
incidence and prevention of sexual assault.
(c) Authorization of Appropriations.--
(1) In general.--There is authorized to be
appropriated to carry out this section $80,000,000 for
each of fiscal years 2007 through 2011.
(2) National sexual violence resource center
allotment.--Of the total amount made available under
this subsection in each fiscal year, not less than
$1,500,000 shall be available for allotment under
subsection (b).
(d) Limitations.--
(1) Supplement not supplant.--Amounts provided to
States under this section shall be used to supplement
and not supplant other Federal, State, and local public
funds expended to provide services of the type
described in subsection (a).
(2) Studies.--A State may not use more than 2
percent of the amount received by the State under this
section for each fiscal year for surveillance studies
or prevalence studies.
(3) Administration.--A State may not use more than
5 percent of the amount received by the State under
this section for each fiscal year for administrative
expenses.
prevention of traumatic brain injury
Sec. 393B. [280b-1c] (a) In General.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may carry out projects to reduce the incidence of
traumatic brain injury. Such projects may be carried out by the
Secretary directly or through awards of grants or contracts to
public or nonprofit private entities. The Secretary may
directly or through such awards provide technical assistance
with respect to the planning, development, and operation of
such projects.
(b) Certain Activities.--Activities under subsection (a)
may include--
(1) the conduct of research into identifying
effective strategies for the prevention of traumatic
brain injury;
(2) the implementation of public information and
education programs for the prevention of such injury
and for broadening the awareness of the public
concerning the public health consequences of such
injury; and
(3) the implementation of a national education and
awareness campaign regarding such injury (in
conjunction with the program of the Secretary regarding
health-status goals for 2010, commonly referred to as
Healthy People 2010), including--
(A) the national dissemination of
information on--
(i) incidence and prevalence; and
(ii) information relating to
traumatic brain injury and the sequelae
of secondary conditions arising from
traumatic brain injury upon discharge
from hospitals and emergency
departments; and
(B) the provision of information in primary
care settings, including emergency rooms and
trauma centers, concerning the availability of
State level services and resources.
(c) Coordination of Activities.--The Secretary shall ensure
that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding traumatic brain injury.
(d) Definition.--For purposes of this section, the term
``traumatic brain injury'' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but may
include brain injuries caused by anoxia due to trauma. The
Secretary may revise the definition of such term as the
Secretary determines necessary, after consultation with States
and other appropriate public or nonprofit private entities.
national program for traumatic brain injury surveillance and registries
Sec. 393C. \1\ [280b-1d] (a) In General.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, may make grants to States or their designees to
develop or operate the State's traumatic brain injury
surveillance system or registry to determine the incidence and
prevalence of traumatic brain injury and related disability, to
ensure the uniformity of reporting under such system or
registry, to link individuals with traumatic brain injury to
services and supports, and to link such individuals with
academic institutions to conduct applied research that will
support the development of such surveillance systems and
registries as may be necessary. A surveillance system or
registry under this section shall provide for the collection of
data concerning--
---------------------------------------------------------------------------
\1\ The amendment by section 2(3) of Public Law 110-206 to
redesignate section 393B (relating to traumatic brain injury
registeries) as section 393C could not be executed because such section
had already been redesignated as section 393C by section 2(1) of Public
Law 110-202.
---------------------------------------------------------------------------
(1) demographic information about each traumatic
brain injury;
(2) information about the circumstances surrounding
the injury event associated with each traumatic brain
injury;
(3) administrative information about the source of
the collected information, dates of hospitalization and
treatment, and the date of injury; and
(4) information characterizing the clinical aspects
of the traumatic brain injury, including the severity
of the injury, outcomes of the injury, the types of
treatments received, and the types of services
utilized.
(b) Not later than 18 months after the date of enactment of
the Traumatic Brain Injury Act of 2008, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention and the Director of the National Institutes of
Health and in consultation with the Secretary of Defense and
the Secretary of Veterans Affairs, shall submit to the relevant
committees of Congress a report that contains the findings
derived from an evaluation concerning activities and procedures
that can be implemented by the Centers for Disease Control and
Prevention to improve the collection and dissemination of
compatible epidemiological studies on the incidence and
prevalence of traumatic brain injury in individuals who were
formerly in the military. The report shall include
recommendations on the manner in which such agencies can
further collaborate on the development and improvement of
traumatic brain injury diagnostic tools and treatments.
SEC. 393C-1. [280B-1E] STUDY ON TRAUMATIC BRAIN INJURY.
(a) Study.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention with respect to
paragraph (1) and in consultation with the Director of the
National Institutes of Health and other appropriate entities
with respect to paragraphs (2), (3), and (4), may conduct a
study with respect to traumatic brain injury for the purpose of
carrying out the following:
(1) In collaboration with appropriate State and
local health-related agencies--
(A) determining the incidence of traumatic
brain injury and prevalence of traumatic brain
injury related disability and the clinical
aspects of the disability in all age groups and
racial and ethnic minority groups in the
general population of the United States,
including institutional settings, such as
nursing homes, correctional facilities,
psychiatric hospitals, child care facilities,
and residential institutes for people with
developmental disabilities; and
(B) reporting national trends in traumatic
brain injury.
(2) Identifying common therapeutic interventions
which are used for the rehabilitation of individuals
with such injuries, and, subject to the availability of
information, including an analysis of--
(A) the effectiveness of each such
intervention in improving the functioning,
including return to work or school and
community participation, of individuals with
brain injuries;
(B) the comparative effectiveness of
interventions employed in the course of
rehabilitation of individuals with brain
injuries to achieve the same or similar
clinical outcome; and
(C) the adequacy of existing measures of
outcomes and knowledge of factors influencing
differential outcomes.
(3) Identifying interventions and therapies that
can prevent or remediate the development of secondary
neurologic conditions related to traumatic brain
injury.
(4) Developing practice guidelines for the
rehabilitation of traumatic brain injury at such time
as appropriate scientific research becomes available.
(b) Dates Certain for Reports.--If the study is conducted
under subsection (a), the Secretary shall, not later than 3
years after the date of the enactment of the Traumatic Brain
Injury Act of 2008, submit to Congress a report describing
findings made as a result of carrying out such subsection (a).
(c) Definition.--For purposes of this section, the term
``traumatic brain injury'' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but may
include brain injuries caused by anoxia due to trauma including
near drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.
SEC. 393D. [28B-1F] PREVENTION OF FALLS AMONG OLDER ADULTS.
(a) Public Education.--The Secretary may--
(1) oversee and support a national education
campaign to be carried out by a nonprofit organization
with experience in designing and implementing national
injury prevention programs, that is directed
principally to older adults, their families, and health
care providers, and that focuses on reducing falls
among older adults and preventing repeat falls; and
(2) award grants, contracts, or cooperative
agreements to qualified organizations, institutions, or
consortia of qualified organizations and institutions,
specializing, or demonstrating expertise, in falls or
fall prevention, for the purpose of organizing State-
level coalitions of appropriate State and local
agencies, safety, health, senior citizen, and other
organizations to design and carry out local education
campaigns, focusing on reducing falls among older
adults and preventing repeat falls.
(b) Research.--
(1) In general.--The Secretary may--
(A) conduct and support research to--
(i) improve the identification of
older adults who have a high risk of
falling;
(ii) improve data collection and
analysis to identify fall risk and
protective factors;
(iii) design, implement, and
evaluate the most effective fall
prevention interventions;
(iv) improve strategies that are
proven to be effective in reducing
falls by tailoring these strategies to
specific populations of older adults;
(v) conduct research in order to
maximize the dissemination of proven,
effective fall prevention
interventions;
(vi) intensify proven interventions
to prevent falls among older adults;
(vii) improve the diagnosis,
treatment, and rehabilitation of
elderly fall victims and older adults
at high risk for falls; and
(viii) assess the risk of falls
occurring in various settings;
(B) conduct research concerning barriers to
the adoption of proven interventions with
respect to the prevention of falls among older
adults;
(C) conduct research to develop, implement,
and evaluate the most effective approaches to
reducing falls among high-risk older adults
living in communities and long-term care and
assisted living facilities; and
(D) evaluate the effectiveness of community
programs designed to prevent falls among older
adults.
(2) Educational support.--The Secretary, either
directly or through awarding grants, contracts, or
cooperative agreements to qualified organizations,
institutions, or consortia of qualified organizations
and institutions, specializing, or demonstrating
expertise, in falls or fall prevention, may provide
professional education for physicians and allied health
professionals, and aging service providers in fall
prevention, evaluation, and management.
(c) Demonstration Projects.--The Secretary may carry out
the following:
(1) Oversee and support demonstration and research
projects to be carried out by qualified organizations,
institutions, or consortia of qualified organizations
and institutions, specializing, or demonstrating
expertise, in falls or fall prevention, in the
following areas:
(A) A multistate demonstration project
assessing the utility of targeted fall risk
screening and referral programs.
(B) Programs designed for community-
dwelling older adults that utilize
multicomponent fall intervention approaches,
including physical activity, medication
assessment and reduction when possible, vision
enhancement, and home modification strategies.
(C) Programs that are targeted to new fall
victims who are at a high risk for second falls
and which are designed to maximize independence
and quality of life for older adults,
particularly those older adults with functional
limitations.
(D) Private sector and public-private
partnerships to develop technologies to prevent
falls among older adults and prevent or reduce
injuries if falls occur.
(2)(A) Award grants, contracts, or cooperative
agreements to qualified organizations, institutions, or
consortia of qualified organizations and institutions,
specializing, or demonstrating expertise, in falls or
fall prevention, to design, implement, and evaluate
fall prevention programs using proven intervention
strategies in residential and institutional settings.
(B) Award 1 or more grants, contracts, or
cooperative agreements to 1 or more qualified
organizations, institutions, or consortia of qualified
organizations and institutions, specializing, or
demonstrating expertise, in falls or fall prevention,
in order to carry out a multistate demonstration
project to implement and evaluate fall prevention
programs using proven intervention strategies designed
for single and multifamily residential settings with
high concentrations of older adults, including--
(i) identifying high-risk populations;
(ii) evaluating residential facilities;
(iii) conducting screening to identify
high-risk individuals;
(iv) providing fall assessment and risk
reduction interventions and counseling;
(v) coordinating services with health care
and social service providers; and
(vi) coordinating post-fall treatment and
rehabilitation.
(3) Award 1 or more grants, contracts, or
cooperative agreements to qualified organizations,
institutions, or consortia of qualified organizations
and institutions, specializing, or demonstrating
expertise, in falls or fall prevention, to conduct
evaluations of the effectiveness of the demonstration
projects described in this subsection.
(d) Priority.--In awarding grants, contracts, or
cooperative agreements under this section, the Secretary may
give priority to entities that explore the use of cost-sharing
with respect to activities funded under the grant, contract, or
agreement to ensure the institutional commitment of the
recipients of such assistance to the projects funded under the
grant, contract, or agreement. Such non-Federal cost sharing
contributions may be provided directly or through donations
from public or private entities and may be in cash or in-kind,
fairly evaluated, including plant, equipment, or services.
(e) Study of Effects of Falls on Health Care Costs.--
(1) In general.--The Secretary may conduct a review
of the effects of falls on health care costs, the
potential for reducing falls, and the most effective
strategies for reducing health care costs associated
with falls.
(2) Report.--If the Secretary conducts the review
under paragraph (1), the Secretary shall, not later
than 36 months after the date of enactment of the
Safety of Seniors Act of 2007, submit to Congress a
report describing the findings of the Secretary in
conducting such review.
general provisions
Sec. 394. [280b-2] (a) The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall establish an advisory committee to advise the Secretary
and such Director with respect to the prevention and control of
injuries.
(b) The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may provide
technical assistance to public and nonprofit private entities
with respect to the planning, development, and operation of any
program or service carried out pursuant to this part. The
Secretary may provide such technical assistance directly or
through grants or contracts.
(c) Not later than February 1 of 1995 and of every second
year thereafter, the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall submit to
the Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the activities
carried out under this part during the preceding 2 fiscal
years. Such report shall include a description of such
activities that were carried out with respect to interpersonal
violence within families and among acquaintances and with
respect to rural areas.
authorizations of appropriations
Sec. 394A. [280b-3] For the purpose of carrying out this
part, there are authorized to be appropriated $50,000,000 for
fiscal year 1994, and \1\ such sums as may be necessary for
each of the fiscal years 1995 through 1998, and such sums as
may be necessary for each of the fiscal years 2001 through
2005.. \1\
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\1\ So in law. Section 1306 of Public Law 106-310 (114 Stat. 1143)
attempts to strike ``and'', but the amendment cannot be executed
because the instructions were to strike ``and'' after ``1994''. (The
word ``and'' appears after ``1994,'', not ``1994''.) Such section 1306
also added the superfluous period.
---------------------------------------------------------------------------
Part K--Health Care Services in the Home
Subpart I--Grants for Demonstration Projects
SEC. 395. [280C] ESTABLISHMENT OF PROGRAM.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall make not less than 5, and not more than
20, grants to States for the purpose of assisting grantees in
carrying out demonstration projects--
(1) to identify low-income individuals who can
avoid institutionalization or prolonged hospitalization
if \2\ skilled nursing care services, homemaker or home
health aide services, or personal care services are
provided in the homes of the individuals;
---------------------------------------------------------------------------
\2\ Section 2(f) of Public Law 102-108 (105 Stat. 550) provides as
follows: ``(f) Public Health Service Act Technical Amendments.--Section
395. [280c](a)(1) after the word `if' insert the words `skilled medical
services,' ''. The text of such section 2(f) does not provide
sufficient amendatory instructions to execute an amendment. The
apparent intent of the Congress was to amend section 395(a)(1) of the
Public Health Service Act (42 U.S.C. 280c(a)(1)).
---------------------------------------------------------------------------
(2) to pay the costs of the provision of such
services in the homes of such individuals; and
(3) to coordinate the provision by public and
private entities of such services, and other long-term
care services, in the homes of such individuals.
(b) Requirement With Respect to Age of Recipients of
Services.--The Secretary may not make a grant under subsection
(a) to a State unless the State agrees to ensure that--
(1) not less than 25 percent of the grant is
expended to provide services under such subsection to
individuals who are not less than 65 years of age; and
(2) of the portion of the grant reserved by the
State for purposes of complying with paragraph (1), not
less than 10 percent is expended to provide such
services to individuals who are not less than 85 years
of age.
(c) Relationship to Items and Services Under Other
Programs.--A State may not make payments from a grant under
subsection (a) for any item or service to the extent that
payment has been made, or can reasonably be expected to be
made, with respect to such item or service--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(2) by an entity that provides health services on a
prepaid basis.
SEC. 396. [280C-1] LIMITATION ON DURATION OF GRANT AND REQUIREMENT OF
MATCHING FUNDS.
(a) Limitation on Duration of Grant.--The period during
which payments are made to a State from a grant under section
395(a) may not exceed 3 years. Such payments shall be subject
to annual evaluation by the Secretary.
(b) Requirement of Matching Funds.--
(1)(A) For the first year of payments to a State
from a grant under section 395(a), the Secretary may
not make such payments in an amount exceeding 75
percent of the costs of services to be provided by the
State pursuant to such section.
(B) For the second year of such payments to a
State, the Secretary may not make such payments in an
amount exceeding 65 percent of the costs of such
services.
(C) For the third year of such payments to a State,
the Secretary may not make such payments in an amount
exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under
section 395(a) to a State unless the State agrees to
make available, directly or through donations from
public or private entities, non-Federal contributions
toward the costs of services to be provided pursuant to
such section in an amount equal to--
(A) for the first year of payments to the
State from the grant, not less than $25 (in
cash or in kind under subsection (c)) for each
$75 of Federal funds provided in the grant;
(B) for the second year of such payments to
the State, not less than $35 (in cash or in
kind under subsection (c)) for each $65 of such
Federal funds; and
(C) for the third year of such payments to
the State, not less than $45 (in cash or in
kind under subsection (c)) for each $55 of such
Federal funds.
(c) Determination of Amount of Non-Federal Contribution.--
Non-Federal contributions required in subsection (b) may be in
cash or in kind, fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal Government, or
services assisted or subsidized to any significant extent by
the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
SEC. 397. [280C-2] GENERAL PROVISIONS.
(a) Limitation on Administrative Expenses.--The Secretary
may not make a grant under section 395(a) to a State unless the
State agrees that not more than 10 percent of the grant will be
expended for administrative expenses with respect to the grant.
(b) Description of Intended Use of Grant.--The Secretary
may not make a grant under section 395(a) to a State unless--
(1) the State submits to the Secretary a
description of the purposes for which the State intends
to expend the grant; and
(2) such description provides information relating
to the programs and activities to be supported and
services to be provided, including--
(A) the number of individuals who will
receive services pursuant to section 395(a) and
the average costs of providing such services to
each such individual; and
(B) a description of the manner in which
such programs and activities will be
coordinated with any similar programs and
activities of public and private entities.
(c) Requirement of Application.--The Secretary may not make
a grant under section 395(a) to a State unless the State has
submitted to the Secretary an application for the grant. The
application shall--
(1) contain the description of intended
expenditures required in subsection (b);
(2) with respect to carrying out the purpose for
which the grant is to be made, provide assurances of
compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such
manner, and contain such information and agreements as
the Secretary determines to be necessary to carry out
this subpart.
(d) Evaluations and Report by Secretary.--The Secretary
shall--
(1) provide for an evaluation of each demonstration
project for which a grant is made under section 395(a);
and
(2) not later than 6 months after the completion of
such evaluations, submit to the Congress a report
describing the findings made as a result of the
evaluations.
(e) Authorizations of Appropriations.--For the purpose of
carrying out this subpart, there are authorized to be
appropriated $5,000,000 for each of the fiscal years 1988
through 1990, $7,500,000 for fiscal year 1991, and such sums as
may be necessary for each of the fiscal years 1992 and 1993.
Subpart II--Grants for Demonstrations Projects With Respect to
Alzheimer's Disease
SEC. 398. [280C-3] ESTABLISHMENT OF PROGRAM.
(a) In General.--The Secretary shall make grants to States
for the purpose of assisting grantees in carrying out
demonstration projects for planning, establishing, and
operating programs--
(1) to coordinate the development and operation
with public and private organizations of diagnostic,
treatment, care management, respite care, legal
counseling, and education services provided within the
State to individuals with Alzheimer's disease or
related disorders and to the families and care
providers of such individuals;
(2) to provide home health care, personal care, day
care, companion services, short-term care in health
facilities, and other respite care to individuals with
Alzheimer's disease or related disorders who are living
in single family homes or in congregate settings;
(3) to improve the access of such individuals to
home-based or community-based long-term care services
(subject to the services being provided by entities
that were providing such services in the State involved
as of October 1, 1995), particularly such individuals
who are members of racial or ethnic minority groups,
who have limited proficiency in speaking the English
language, or who live in rural areas; and
(4) to provide to health care providers, to
individuals with Alzheimer's disease or related
disorders, to the families of such individuals, to
organizations established for such individuals and such
families, and to the general public, information with
respect to--
(A) diagnostic services, treatment
services, and related services available to
such individuals and to the families of such
individuals;
(B) sources of assistance in obtaining such
services, including assistance under
entitlement programs; and
(C) the legal rights of such individuals
and such families.
(b) Requirement With Respect to Certain Expenditures.--The
Secretary may not make a grant under subsection (a) to a State
unless the State agrees to expend not less than 50 percent of
the grant for the provision of services described in subsection
(a)(2).
(c) Relationship to Items and Services Under Other
Programs.--A State may not make payments from a grant under
subsection (a) for any item or service to the extent that
payment has been made, or can reasonably be expected to be
made, with respect to such item or service--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(2) by an entity that provides health services on a
prepaid basis.
SEC. 398A. [280C-4] REQUIREMENT OF MATCHING FUNDS \1\
---------------------------------------------------------------------------
\1\ So in law. The section heading lacks a period. See section
301(b)(1) of Public Law 105-392 (112 Stat. 3586).
---------------------------------------------------------------------------
(a) Requirement of Matching Funds.--
(1)(A) For the first year of payments to a State
from a grant under section 398(a), the Secretary may
not make such payments in an amount exceeding 75
percent of the costs of services to be provided by the
State pursuant to such section.
(B) For the second year of such payments to a
State, the Secretary may not make such payments in an
amount exceeding 65 percent of the costs of such
services.
(C) For the third or subsequent year of such
payments to a State, the Secretary may not make such
payments in an amount exceeding 55 percent of the costs
of such services.
(2) The Secretary may not make a grant under
section 398(a) to a State unless the State agrees to
make available, directly or through donations from
public or private entities, non-Federal contributions
toward the costs of services to be provided pursuant to
such section in an amount equal to--
(A) for the first year of payments to the
State from the grant, not less than $25 (in
cash or in kind under subsection (c)) for each
$75 of Federal funds provided in the grant;
(B) for the second year of such payments to
the State, not less than $35 (in cash or in
kind under subsection (c)) for each $65 of such
Federal funds; and
(C) for the third or subsequent year of
such payments to the State, not less than $45
(in cash or in kind under subsection (c)) for
each $55 of such Federal funds.
(b) Determination of Amount of Non-Federal Contribution.--
Non-Federal contributions required in subsection (b) may be in
cash or in kind, fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal Government, or
services assisted or subsidized to any significant extent by
the Federal Government, may not be included in determining the
amount of such non-Federal contributions.
SEC. 398B. [280C-5] GENERAL PROVISIONS.
(a) Limitation on Administrative Expenses.--The Secretary
may not make a grant under section 398(a) to a State unless the
State agrees that not more than 10 percent of the grant will be
expended for administrative expenses with respect to the grant.
(b) Description of Intended Use of Grant.--The Secretary
may not make a grant under section 398(a) to a State unless--
(1) the State submits to the Secretary a
description of the purposes for which the State intends
to expend the grant; and
(2) such description provides information relating
to the programs and activities to be supported and
services to be provided, including--
(A) the number of individuals who will
receive services pursuant to section 398(a) and
the average costs of providing such services to
each such individual; and
(B) a description of the manner in which
such programs and activities will be
coordinated with any similar programs and
activities of public and private entities.
(c) Requirement of Application.--The Secretary may not make
a grant under section 398(a) to a State unless the State has
submitted to the Secretary an application for the grant. The
application shall--
(1) contain the description of intended
expenditures required in subsection (b);
(2) with respect to carrying out the purpose for
which the grant is to be made, provide assurances of
compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such
manner, and contain such information and agreements as
the Secretary determines to be necessary to carry out
this subpart.
(d) Evaluations and Report by Secretary.--The Secretary
shall--
(1) provide for an evaluation of each demonstration
project for which a grant is made under section 398(a);
and
(2) not later than 6 months after the completion of
such evaluations, submit to the Congress a report
describing the findings made as a result of the
evaluations.
(e) Authorizations of Appropriations.--For the purpose of
carrying out this subpart, there are authorized to be
appropriated $5,000,000 for each of the fiscal years 1988
through 1990, $7,500,000 for fiscal year 1991, such sums as may
be necessary for each of the fiscal years 1992 and 1993,
$8,000,000 for fiscal year 1998, and such sums as may be
necessary for each of the fiscal years 1999 through 2002.
Subpart III--Grants for Home Visiting Services for At-Risk Families
SEC. 399. [280C-6] PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD
HEALTH.
(a) In General.--
(1) Establishment of program.--The Secretary,
acting through the Administrator of the Health
Resources and Services Administration, shall make
grants to eligible entities to pay the Federal share of
the cost of providing the services specified in
subsection (b) to families in which a member is--
(A) a pregnant woman at risk of delivering
an infant with a health or developmental
complication; or
(B) a child less than 3 years of age--
(i) who is experiencing or is at
risk of a health or developmental
complication, or of child abuse or
neglect; or
(ii) who has been prenatally
exposed to maternal substance abuse.
(2) Minimum period of awards; administrative
consultations.--
(A) The Secretary shall award grants under
paragraph (1) for periods of at least three
years.
(B) The Administrator of the Administration
for Children, Youth, and Families and the
Director of the National Commission to Prevent
Infant Mortality shall be consulted regarding
the promulgation of program guidelines and
funding priorities under this section.
(3) Requirement of status as medicaid provider.--
(A) Subject to subparagraph (B), the
Secretary may make a grant under paragraph (1)
only if, in the case of any service under such
paragraph that is covered in the State plan
approved under title XIX of the Social Security
Act for the State involved--
(i) the entity involved will
provide the service directly, and the
entity has entered into a participation
agreement under the State plan and is
qualified to receive payments under
such plan; or
(ii) the entity will enter into an
agreement with an organization under
which the organization will provide the
service, and the organization has
entered into such a participation
agreement and is qualified to receive
such payments.
(B)(i) In the case of an organization
making an agreement under subparagraph (A)(ii)
regarding the provision of services under
paragraph (1), the requirement established in
such subparagraph regarding a participation
agreement shall be waived by the Secretary if
the organization does not, in providing health
or mental health services, impose a charge or
accept reimbursement available from any third-
party payor, including reimbursement under any
insurance policy or under any Federal or State
health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether
the organization accepts voluntary donations
regarding the provision of services to the
public.
(b) Home Visiting Services for Eligible Families.--With
respect to an eligible family, each of the following services
shall, directly or through arrangement with other public or
nonprofit private entities, be available (as applicable to the
family member involved) in each project operated with a grant
under subsection (a):
(1) Prenatal and postnatal health care.
(2) Primary health care for the children, including
developmental assessments.
(3) Education for the parents concerning infant
care and child development, including the development
and utilization of parent and teacher resource networks
and other family resource and support networks where
such networks are available.
(4) Upon the request of a parent, providing the
education described in paragraph (3) to other
individuals who have responsibility for caring for the
children.
(5) Education for the parents concerning behaviors
that adversely affect health.
(6) Assistance in obtaining necessary health,
mental health, developmental, social, housing, and
nutrition services and other assistance, including
services and other assistance under maternal and child
health programs; the special supplemental nutrition
program for women, infants, and children; section 17 of
the Child Nutrition Act of 1966; title V of the Social
Security Act; title XIX of such Act (including the
program for early and periodic screening, diagnostic,
and treatment services described in section 1905(r) of
such Act); titles IV and XIX of the Social Security
Act; housing programs; other food assistance programs;
and appropriate alcohol and drug dependency treatment
programs, according to need.
(c) Considerations in Making Grants.--In awarding grants
under subsection (a), the Secretary shall take into
consideration--
(1) the ability of the entity involved to provide,
either directly or through linkages, a broad range of
preventive and primary health care services and related
social, family support, and developmental services;
(2) different combinations of professional and lay
home visitors utilized within programs that are
reflective of the identified service needs and
characteristics of target populations;
(3) the extent to which the population to be
targeted has limited access to health care, and related
social, family support, and developmental services; and
(4) whether such grants are equitably distributed
among urban and rural settings and whether entities
serving Native American communities are represented
among the grantees.
(d) Federal Share.--With respect to the costs of carrying
out a project under subsection (a), a grant under such
subsection for the project may not exceed 90 percent of such
costs. To be eligible to receive such a grant, an applicant
must provide assurances that the applicant will obtain at least
10 percent of such costs from non-Federal funds (and such
contributions to such costs may be in cash or in-kind,
including facilities and personnel).
(e) Rule of Construction Regarding At-Risk Births.--For
purposes of subsection (a)(1), a pregnant woman shall be
considered to be at risk of delivering an infant with a health
or developmental complication if during the pregnancy the
woman--
(1) lacks appropriate access to, or information
concerning, early and routine prenatal care;
(2) lacks the transportation necessary to gain
access to the services described in subsection (b);
(3) lacks appropriate child care assistance, which
results in impeding the ability of such woman to
utilize health and related social services;
(4) is fearful of accessing substance abuse
services or child and family support services; or
(5) is a minor with a low income.
(f) Delivery of Services and Case Management.--
(1) Case management model.--Home visiting services
provided under this section shall be delivered
according to a case management model, and a registered
nurse, licensed social worker, or other licensed health
care professional with experience and expertise in
providing health and related social services in home
and community settings shall be assigned as the case
manager for individual cases under such model.
(2) Case manager.--A case manager assigned under
paragraph (1) shall have primary responsibility for
coordinating and overseeing the development of a plan
for each family that is to receive home visiting
services under this section, and for coordinating the
delivery of such services provided through appropriate
personnel.
(3) Appropriate personnel.--In determining which
personnel shall be utilized in the delivery of
services, the case manager shall consider--
(A) the stated objective of the project to
be operated with the grant, as determined after
considering identified gaps in the current
service delivery system; and
(B) the nature of the needs of the family
to be served, as determined at the initial
assessment of the family that is conducted by
the case manager, and through follow-up
contacts by other providers of home visiting
services.
(4) Family service plan.--A case manager, in
consultation with a team established in accordance with
paragraph (5) for the family involved, shall develop a
plan for the family following the initial visit to the
home of the family. Such plan shall reflect--
(A) an assessment of the health and related
social service needs of the family;
(B) a structured plan for the delivery of
home visiting services to meet the identified
needs of the family;
(C) the frequency with which such services
are to be provided to the family;
(D) ongoing revisions made as the needs of
family members change; and
(E) the continuing voluntary participation
of the family in the plan.
(5) Home visiting services team.--The team to be
consulted under paragraph (4) on behalf of a family
shall include, as appropriate, other nursing
professionals, physician assistants, social workers,
child welfare professionals, infant and early childhood
specialists, nutritionists, and laypersons trained as
home visitors. The case manager shall ensure that the
plan is coordinated with those physician services that
may be required by the mother or child.
(g) Outreach.--Each grantee under subsection (a) shall
provide outreach and casefinding services to inform eligible
families of the availability of home visiting services from the
project.
(h) Confidentiality.--In accordance with applicable State
law, an entity receiving a grant under subsection (a) shall
maintain confidentiality with respect to services provided to
families under this section.
(i) Certain Assurances.--The Secretary may award a grant
under subsection (a) only if the entity involved provides
assurances satisfactory to the Secretary that--
(1) the entity will provide home visiting services
with reasonable frequency--
(A) to families with pregnant women, as
early in the pregnancy as is practicable, and
until the infant reaches at least 2 years of
age; and
(B) to other eligible families, for at
least 2 years; and
(2) the entity will coordinate with public health
and related social service agencies to prevent
duplication of effort and improve the delivery of
comprehensive health and related social services.
(j) Submission to Secretary of Certain Information.--The
Secretary may award a grant under subsection (a) only if the
entity involved submits to the Secretary--
(1) a description of the population to be targeted
for home visiting services and methods of outreach and
casefinding for identifying eligible families,
including the use of lay home visitors where
appropriate;
(2) a description of the types and qualifications
of home visitors used by the entity and the process by
which the entity will provide continuing training and
sufficient support to the home visitors; and
(3) such other information as the Secretary
determines to be appropriate.
(k) Limitation Regarding Administrative Expenses.--Not more
than 10 percent of a grant under subsection (a) may be expended
for administrative expenses with respect to the grant. The
costs of training individuals to serve in the project involved
are not subject to the preceding sentence.
(l) Restrictions on Use of Grant.--To be eligible to
receive a grant under this section, an entity must agree that
the grant will not be expended--
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of
services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other than minor
remodeling) any building or other facility, or purchase
major medical equipment;
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds; or
(5) to provide financial assistance to any entity
other than a public or nonprofit private entity.
(m) Reports to Secretary.--To be eligible to receive a
grant under this section, an entity must agree to submit an
annual report on the services provided under this section to
the Secretary in such manner and containing such information as
the Secretary by regulation requires. At a minimum, the entity
shall report information concerning eligible families,
including--
(1) the characteristics of the families and
children receiving services under this section;
(2) the usage, nature, and location of the
provider, of preventive health services, including
prenatal, primary infant, and child health care;
(3) the incidence of low birthweight and premature
infants;
(4) the length of hospital stays for pre- and post-
partum women and their children;
(5) the incidence of substantiated child abuse and
neglect for all children within participating families;
(6) the number of emergency room visits for routine
health care;
(7) the source of payment for health care services
and the extent to which the utilization of health care
services, other than routine screening and medical
care, available to the individuals under the program
established under title XIX of the Social Security Act,
and under other Federal, State, and local programs, is
reduced;
(8) the number and type of referrals made for
health and related social services, including alcohol
and drug treatment services, and the utilization of
such services provided by the grantee; and
(9) the incidence of developmental disabilities.
(n) Requirement of Application.--The Secretary may make a
grant under subsection (a) only if--
(1) an application for the grant is submitted to
the Secretary;
(2) the application contains the agreements and
assurances required in this section, and the
information required in subsection (j);
(3) the application contains evidence that the
preparation of the application has been coordinated
with the State agencies responsible for maternal and
child health and child welfare, and coordinated with
services provided under part C of the Individuals with
Disabilities Education Act; and
(4) the application is in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this section.
(o) Peer Review.--
(1) Requirement.--In making determinations for
awarding grants under subsection (a), the Secretary
shall rely on the recommendations of the peer review
panel established under paragraph (2).
(2) Composition.--The Secretary shall establish a
review panel to make recommendations under paragraph
(1) that shall be composed of--
(A) national experts in the fields of
maternal and child health, child abuse and
neglect, and the provision of community-based
primary health services; and
(B) representatives of relevant Federal
agencies, including the Health Resources and
Services Administration, the Substance Abuse
and Mental Health Services Administration, the
Administration for Children, Youth, and
Families, the U.S. Advisory Board on Child
Abuse and Neglect, and the National Commission
to Prevent Infant Mortality.
(p) Evaluations.--
(1) In general.--The Secretary shall, directly or
through contracts with public or private entities--
(A) conduct evaluations to determine the
effectiveness of projects under subsection (a)
in reducing the incidence of children born with
health or developmental complications, the
incidence among children less than 3 years of
age of such complications, and the incidence of
child abuse and neglect; and
(B) not less than once during each 3-year
period, prepare and submit to the appropriate
committees of Congress a report concerning the
results of such evaluations.
(2) Contents.--The evaluations conducted under
paragraph (1) shall--
(A) include a summary of the data contained
in the annual reports submitted under
subsection (m);
(B) assess the relative effectiveness of
projects under subsection (a) in urban and
rural areas, and among programs utilizing
differing combinations of professionals and
trained home visitors recruited from the
community to meet the needs of defined target
service populations; and
(C) make further recommendations necessary
or desirable to increase the effectiveness of
such projects.
(q) Definitions.--For purposes of this section:
(1) The term ``eligible entity'' includes public
and nonprofit private entities that provide health or
related social services, including community-based
organizations, visiting nurse organizations, hospitals,
local health departments, community health centers,
Native Hawaiian health centers, nurse managed clinics,
family service agencies, child welfare agencies,
developmental service providers, family resource and
support programs, and resource mothers projects.
(2) The term ``eligible family'' means a family
described in subsection (a).
(3) The term ``health or developmental
complication'', with respect to a child, means--
(A) being born in an unhealthy or
potentially unhealthy condition, including
premature birth, low birthweight, and prenatal
exposure to maternal substance abuse;
(B) a condition arising from a condition
described in subparagraph (A);
(C) a physical disability or delay; and
(D) a developmental disability or delay.
(4) The term ``home visiting services'' means the
services specified in subsection (b), provided at the
residence of the eligible family involved or provided
pursuant to arrangements made for the family (including
arrangements for services in community settings).
(5) The term ``home visitors'' means providers of
home visiting services.
(r) Authorization of Appropriations.--For the purpose of
carrying out this section, there is authorized to be
appropriated $30,000,000 for each of the fiscal years 1993 and
1994.
[Part L \1\--]
---------------------------------------------------------------------------
\1\ The content of section 399A above, and the placement of the
section in this Act, probably do not reflect the intent of the
Congress. Section 399A formerly was section 399D. Section 3106 of
Public Law 106-310 (114 Stat. 1175) attempts to make various amendments
to section 399D, but the amendments cannot be executed because section
399D was redesignated as section 399A by section 502(1) of such Public
Law (114 Stat. 1115). (Section 399D now relates to technical assistance
in operations of Statewide cancer registries.)
Further, section 3106(m) of the Public Law (114 Stat. 1179)
attempts to transfer section 399D to title V of this Act as a section
519, but this transfer has not been executed because it applied to
section 399D ``as amended by this section'' (section 3106), and no
amendments described in section 3106 have been made to section 399D.
As a conforming amendment, section 3106(n) of the Public Law
provided that title III of this Act ``is amended by striking the
heading for part L''. This amendment has been executed, but for the
convenience of the reader, a designation for a part L is shown above in
brackets to indicate the probable intent of the Congress that section
399A is not included in part K of title III.
For the convenience of the reader, an italicized note follows
section 399A above showing the section as it would appear if the
amendments described in section 3106 of the Public Law were executed to
section 399A.
---------------------------------------------------------------------------
SEC. 399A. [280D] GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE
ABUSERS.\1\
(a) Establishment.--
(1) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall make grants to public and
nonprofit private entities for the purpose of carrying
out programs--
(A) to provide the services described in
subsection (b) to children of substance
abusers;
(B) to provide the applicable services
described in subsection (c) to families in
which a member is a substance abuser; and
(C) to identify such children and such
families.
(2) Administrative consultations.--The
Administrator of the Administration for Children,
Youth, and Families and the Administrator of the
Substance Abuse and Mental Health Services
Administration shall be consulted regarding the
promulgation of program guidelines and funding
priorities under this section.
(3) Requirement of status as medicaid provider.--
(A) Subject to subparagraph (B), the
Secretary may make a grant under paragraph (1)
only if, in the case of any service under such
paragraph that is covered in the State plan
approved under title XIX of the Social Security
Act for the State involved--
(i) the entity involved will
provide the service directly, and the
entity has entered into a participation
agreement under the State plan and is
qualified to receive payments under
such plan; or
(ii) the entity will enter into an
agreement with an organization under
which the organization will provide the
service, and the organization has
entered into such a participation
agreement and is qualified to receive
such payments.
(B)(i) In the case of an organization
making an agreement under subparagraph (A)(ii)
regarding the provision of services under
paragraph (1), the requirement established in
such subparagraph regarding a participation
agreement shall be waived by the Secretary if
the organization does not, in providing health
or mental health services, impose a charge or
accept reimbursement available from any third-
party payor, including reimbursement under any
insurance policy or under any Federal or State
health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether
the organization accepts voluntary donations
regarding the provision of services to the
public.
(b) Services for Children of Substance Abusers.--The
Secretary may make a grant under subsection (a) only if the
applicant involved agrees to make available (directly or
through agreements with other entities) to children of
substance abusers each of the following services:
(1) Periodic evaluation of children for
developmental, psychological, and medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental health
services.
(4) Therapeutic intervention services for children,
including provision of therapeutic child care.
(5) Preventive counseling services.
(6) Counseling related to the witnessing of chronic
violence.
(7) Referrals for, and assistance in establishing
eligibility for, services provided under--
(A) education and special education
programs;
(B) Head Start programs established under
the Head Start Act;
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by
Federal, State, or local governments; and
(F) programs offered by vocational
rehabilitation agencies, recreation
departments, and housing agencies.
(8) Additional developmental services that are
consistent with the provision of early intervention
services, as such term is defined in part C of the
Individuals with Disabilities Education Act.
(c) Services for Affected Families.--The Secretary may make
a grant under subsection (a) only if, in the case of families
in which a member is a substance abuser, the applicant involved
agrees to make available (directly or through agreements with
other entities) each of the following services, as applicable
to the family member involved:
(1) Services as follows, to be provided by a public
health nurse, social worker, or similar professional,
or by a trained worker from the community who is
supervised by a professional:
(A) Counseling to substance abusers on the
benefits and availability of substance abuse
treatment services and services for children of
substance abusers.
(B) Assistance to substance abusers in
obtaining and using substance abuse treatment
services and in obtaining the services
described in subsection (b) for their children.
(C) Visiting and providing support to
substance abusers, especially pregnant women,
who are receiving substance abuse treatment
services or whose children are receiving
services under subsection (b).
(2) In the case of substance abusers:
(A) Encouragement and, where necessary,
referrals to participate in appropriate
substance abuse treatment.
(B) Primary health care and mental health
services, including prenatal and post partum
care for pregnant women.
(C) Consultation and referral regarding
subsequent pregnancies and life options,
including education and career planning.
(D) Where appropriate, counseling regarding
family conflict and violence.
(E) Remedial education services.
(F) Referrals for, and assistance in
establishing eligibility for, services
described in subsection (b)(7).
(3) In the case of substance abusers, spouses of
substance abusers, extended family members of substance
abusers, caretakers of children of substance abusers,
and other people significantly involved in the lives of
substance abusers or the children of substance abusers:
(A) An assessment of the strengths and
service needs of the family and the assignment
of a case manager who will coordinate services
for the family.
(B) Therapeutic intervention services, such
as parental counseling, joint counseling
sessions for families and children, and family
therapy.
(C) Child care or other care for the child
to enable the parent to attend treatment or
other activities and respite care services.
(D) Parenting education services and parent
support groups.
(E) Support services, including, where
appropriate, transportation services.
(F) Where appropriate, referral of other
family members to related services such as job
training.
(G) Aftercare services, including continued
support through parent groups and home visits.
(d) Considerations in Making Grants.--In making grants
under subsection (a), the Secretary shall ensure that the
grants are reasonably distributed among the following types of
entities:
(1) Alcohol and drug treatment programs, especially
those providing treatment to pregnant women and mothers
and their children.
(2) Public or nonprofit private entities that
provide health or social services to disadvantaged
populations, and that have--
(A) expertise in applying the services to
the particular problems of substance abusers
and the children of substance abusers; and
(B) an affiliation or contractual
relationship with one or more substance abuse
treatment programs.
(3) Consortia of public or nonprofit private
entities that include at least one substance abuse
treatment program.
(4) Indian tribes.
(e) Federal Share.--The Federal share of a program carried
out under subsection (a) shall be 90 percent. The Secretary
shall accept the value of in-kind contributions, including
facilities and personnel, made by the grant recipient as a part
or all of the non-Federal share of grants.
(f) Coordination With Other Providers.--The Secretary may
make a grant under subsection (a) only if the applicant
involved agrees to coordinate its activities with those of the
State lead agency, and the State Interagency Coordinating
Council, under part C of the Individuals with Disabilities
Education Act.
(g) Restrictions on Use of Grant.--The Secretary may make a
grant under subsection (a) only if the applicant involved
agrees that the grant will not be expended--
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of
services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other than minor
remodeling) any building or other facility, or purchase
major medical equipment;
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds; or
(5) to provide financial assistance to any entity
other than a public or nonprofit private entity.
(h) Submission to Secretary of Certain Information.--The
Secretary may make a grant under subsection (a) only if the
applicant involved submits to the Secretary--
(1) a description of the population that is to
receive services under this section and a description
of such services that are to be provided and measurable
goals and objectives;
(2) a description of the mechanism that will be
used to involve the local public agencies responsible
for health, mental health, child welfare, education,
juvenile justice, developmental disabilities, and
substance abuse treatment programs in planning and
providing services under this section, as well as
evidence that the proposal has been coordinated with
the State agencies responsible for administering those
programs and the State agency responsible for
administering public maternal and child health
services;
(3) information demonstrating that the applicant
has established a collaborative relationship with child
welfare agencies and child protective services that
will enable the applicant, where appropriate, to--
(A) provide advocacy on behalf of substance
abusers and the children of substance abusers
in child protective services cases;
(B) provide services to help prevent the
unnecessary placement of children in substitute
care; and
(C) promote reunification of families or
permanent plans for the placement of the child;
and
(4) such other information as the Secretary
determines to be appropriate.
(i) Reports to Secretary.--The Secretary may make a grant
under subsection (a) only if the applicant involved agrees that
for each fiscal year for which the applicant receives such a
grant the applicant, in accordance with uniform standards
developed by the Secretary, will submit to the Secretary a
report containing--
(1) a description of specific services and
activities provided under the grant;
(2) information regarding progress toward meeting
the program's stated goals and objectives;
(3) information concerning the extent of use of
services provided under the grant, including the number
of referrals to related services and information on
other programs or services accessed by children,
parents, and other caretakers;
(4) information concerning the extent to which
parents were able to access and receive treatment for
alcohol and drug abuse and sustain participation in
treatment over time until the provider and the
individual receiving treatment agree to end such
treatment, and the extent to which parents re-enter
treatment after the successful or unsuccessful
termination of treatment;
(5) information concerning the costs of the
services provided and the source of financing for
health care services;
(6) information concerning--
(A) the number and characteristics of
families, parents, and children served,
including a description of the type and
severity of childhood disabilities, and an
analysis of the number of children served by
age;
(B) the number of children served who
remained with their parents during the period
in which entities provided services under this
section;
(C) the number of children served who were
placed in out-of-home care during the period in
which entities provided services under this
section;
(D) the number of children described in
subparagraph (C) who were reunited with their
families; and
(E) the number of children described in
subparagraph (C) for whom a permanent plan has
not been made or for whom the permanent plan is
other than family reunification;
(7) information on hospitalization or emergency
room use by the family members participating in the
program; and
(8) such other information as the Secretary
determines to be appropriate.
(j) Requirement of Application.--The Secretary may make any
grant under subsection (a) only if--
(1) an application for the grant is submitted to
the Secretary;
(2) the application contains the agreements
required in this section and the information required
in subsection (h); and
(3) the application is in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this section.
(k) Peer Review.--
(1) Requirement.--In making determinations for
awarding grants under subsection (a), the Secretary
shall rely on the recommendations of the peer review
panel established under paragraph (2).
(2) Composition.--The Secretary shall establish a
review panel to make recommendations under paragraph
(1) that shall be composed of--
(A) national experts in the fields of
maternal and child health, substance abuse
treatment, and child welfare; and
(B) representatives of relevant Federal
agencies, including the Health Resources and
Services Administration, the Substance Abuse
and Mental Health Services Administration, and
the Administration for Children, Youth, and
Families.
(l) Evaluations.--The Secretary shall periodically conduct
evaluations to determine the effectiveness of programs
supported under subsection (a)--
(1) in reducing the incidence of alcohol and drug
abuse among substance abusers participating in the
programs;
(2) in preventing adverse health conditions in
children of substance abusers;
(3) in promoting better utilization of health and
developmental services and improving the health,
developmental, and psychological status of children
receiving services under the program;
(4) in improving parental and family functioning;
(5) in reducing the incidence of out-of-home
placement for children whose parents receive services
under the program; and
(6) in facilitating the reunification of families
after children have been placed in out-of-home care.
(m) Report to Congress.--Not later than 2 years after the
date on which amounts are first appropriated under subjection
(o), the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, a report
that contains a description of programs carried out under this
section. At a minimum, the report shall contain--
(1) information concerning the number and type of
programs receiving grants;
(2) information concerning the type and use of
services offered;
(3) information concerning--
(A) the number and characteristics of
families, parents, and children served;
(B) the number of children served who
remained with their parents during or after the
period in which entities provided services
under this section;
(C) the number of children served who were
placed in out-of-home care during the period in
which entities provided services under this
section;
(D) the number of children described in
subparagraph (C) who were reunited with their
families; and
(E) the number of children described in
subparagraph (C) who were permanently placed in
out-of-home care;
analyzed by the type of entity described in subsection
(d) that provided services;
(4) an analysis of the access provided to, and use
of, related services and alcohol and drug treatment
through programs carried out under this section; and
(5) a comparison of the costs of providing services
through each of the types of entities described in
subsection (d).
(n) Data Collection.--The Secretary shall periodically
collect and report on information concerning the numbers of
children in substance abusing families, including information
on the age, gender and ethnicity of the children, the
composition and income of the family, and the source of health
care finances.
(o) Definitions.--For purposes of this section:
(1) The term ``caretaker'', with respect to a child
of a substance abuser, means any individual acting in a
parental role regarding the child (including any birth
parent, foster parent, adoptive parent, relative of
such a child, or other individual acting in such a
role).
(2) The term ``children of substance abusers''
means--
(A) children who have lived or are living
in a household with a substance abuser who is
acting in a parental role regarding the
children; and
(B) children who have been prenatally
exposed to alcohol or other dangerous drugs.
(3) The term ``Indian tribe'' means any tribe,
band, nation, or other organized group or community of
Indians, including any Alaska Native village (as
defined in, or established pursuant to, the Alaska
Native Claims Settlement Act), that is recognized as
eligible for the special programs and services provided
by the United States to Indians because of their status
as Indians.
(4) The term ``public or nonprofit private entities
that provide health or social services to disadvantaged
populations'' includes community-based organizations,
local public health departments, community action
agencies, hospitals, community health centers, child
welfare agencies, developmental disabilities service
providers, and family resource and support programs.
(5) The term ``substance abuse'' means the abuse of
alcohol or other drugs.
(p) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out this section, there are
authorized to be appropriated $50,000,000 for fiscal
year 1993, and such sums as may be necessary for fiscal
year 1994.
(2) Contingent authority regarding training of
certain individuals.--Of the amounts appropriated under
paragraph (1) for a fiscal year in excess of
$25,000,000, the Secretary may make available not more
than 15 percent for the training of health care
professionals and other personnel (including child
welfare providers) who provide services to children and
families of substance abusers.
======================================================================
NOTE: For the convenience of the reader, the following
indicates the probable intent of the Congress by showing
section 399A as the section would appear if the amendments
described in section 3106 of Public Law 106-310 (114 Stat.
1175) were executed to section 399A, rather than to section
399D as instructed by such section 3106, including the
amendment that redesignates the section as section 519 (toward
the purpose of transferring the section to title V of this
Act). See footnote on page 619.
SEC. 519. [280D] GRANTS FOR SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.
(a) Establishment.--
(1) In general.--The Secretary, acting through the
Administrator of the Substance Abuse and Mental Health
Services Administration, shall make grants to public
and nonprofit private entities for the purpose of
carrying out programs--
(A) to provide the services described in
subsection (b) to children of substance
abusers;
(B) to provide the applicable services
described in subsection (c) to families in
which a member is a substance abuser;
(C) to identify such children and such
families through youth service agencies, family
social services, child care providers, Head
Start, schools and after-school programs, early
childhood development programs, community-based
family resource and support centers, the
criminal justice system, health, substance
abuse and mental health providers through
screenings conducted during regular childhood
examinations and other examinations, self and
family member referrals, substance abuse
treatment services, and other providers of
services to children and families; and
(D) to provide education and training to
health, substance abuse and mental health
professionals, and other providers of services
to children and families through youth service
agencies, family social services, child care,
Head Start, schools and after-school programs,
early childhood development programs,
community-based family resource and support
centers, the criminal justice system, and other
providers of services to children and families.
(2) Administrative consultations.--The
Administrator of the Administration for Children,
Youth, and Families and the Administrator of the Health
Resources and Services Administration shall be
consulted regarding the promulgation of program
guidelines and funding priorities under this section.
(3) Requirement of status as medicaid provider.--
(A) Subject to subparagraph (B), the
Secretary may make a grant under paragraph (1)
only if, in the case of any service under such
paragraph that is covered in the State plan
approved under title XIX of the Social Security
Act for the State involved--
(i)(I) the entity involved will
provide the service directly, and the
entity has entered into a participation
agreement under the State plan and is
qualified to receive payments under
such plan; or
(II) the entity will enter into an
agreement with an organization under
which the organization will provide the
service, and the organization has
entered into such a participation
agreement and is qualified to receive
such payments; and
(ii) the entity will identify
children who may be eligible for
medical assistance under a State
program under title XIX or XXI of the
Social Security Act.
(B)(i) In the case of an organization
making an agreement under subparagraph (A)(ii)
regarding the provision of services under
paragraph (1), the requirement established in
such subparagraph regarding a participation
agreement shall be waived by the Secretary if
the organization does not, in providing health
or mental health services, impose a charge or
accept reimbursement available from any third-
party payor, including reimbursement under any
insurance policy or under any Federal or State
health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether
the organization accepts voluntary donations
regarding the provision of services to the
public.
(b) Services for Children of Substance Abusers.--The
Secretary may make a grant under subsection (a) only if the
applicant involved agrees to make available (directly or
through agreements with other entities) to children of
substance abusers each of the following services:
(1) Periodic evaluation of children for
developmental, psychological, alcohol and drug, and
medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental health
services.
(4) Therapeutic intervention services for children,
including provision of therapeutic child care.
(5) Developmentally and age-appropriate drug and
alcohol early intervention, treatment and prevention
services.
(6) Counseling related to the witnessing of chronic
violence.
(7) Referrals for, and assistance in establishing
eligibility for, services provided under--
(A) education and special education
programs;
(B) Head Start programs established under
the Head Start Act;
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by
Federal, State, or local governments; and
(F) programs offered by vocational
rehabilitation agencies, recreation
departments, and housing agencies.
(8) Additional developmental services that are
consistent with the provision of early intervention
services, as such term is defined in part H of the
Individuals with Disabilities Education Act.
Services shall be provided under paragraphs (2) through (8) by
a public health nurse, social worker, or similar professional,
or by a trained worker from the community who is supervised by
a professional, or by an entity, where the professional or
entity provides assurances that the professional or entity is
licensed or certified by the State if required and is complying
with applicable licensure or certification requirements.
(c) Services for Affected Families.--The Secretary may make
a grant under subsection (a) only if, in the case of families
in which a member is a substance abuser, the applicant involved
agrees to make available (directly or through agreements with
other entities) each of the following services, as applicable
to the family member involved:
(1) Services as follows, to be provided by a public
health nurse, social worker, or similar professional,
or by a trained worker from the community who is
supervised by a professional, or by an entity, where
the professional or entity provides assurances that the
professional or entity is licensed or certified by the
State if required and is complying with applicable
licensure or certification requirements:
(A) Counseling to substance abusers on the
benefits and availability of substance abuse
treatment services and services for children of
substance abusers.
(B) Assistance to substance abusers in
obtaining and using substance abuse treatment
services and in obtaining the services
described in subsection (b) for their children.
(C) Visiting and providing support to
substance abusers, especially pregnant women,
who are receiving substance abuse treatment
services or whose children are receiving
services under subsection (b).
(D) Aggressive outreach to family members
with substance abuse problems.
(E) Inclusion of consumer in the
development, implementation, and monitoring of
Family Services Plan.
(2) In the case of substance abusers:
(A) Alcohol and drug treatment services,
including screening and assessment, diagnosis,
detoxification, individual, group and family
counseling, relapse prevention, pharmacotherapy
treatment, after-care services, and case
management.
(B) Primary health care and mental health
services, including prenatal and post partum
care for pregnant women.
(C) Consultation and referral regarding
subsequent pregnancies and life options and
counseling on the human immunodeficiency virus
and acquired immune deficiency syndrome.
(D) Where appropriate, counseling regarding
family violence.
(E) Career planning and education services.
(F) Referrals for, and assistance in
establishing eligibility for, services
described in subsection (b)(7).
(3) In the case of substance abusers, spouses of
substance abusers, extended family members of substance
abusers, caretakers of children of substance abusers,
and other people significantly involved in the lives of
substance abusers or the children of substance abusers:
(A) An assessment of the strengths and
service needs of the family and the assignment
of a case manager who will coordinate services
for the family.
(B) Therapeutic intervention services, such
as parental counseling, joint counseling
sessions for families and children, and family
therapy.
(C) Child care or other care for the child
to enable the parent to attend treatment or
other activities and respite care services.
(D) Parenting education services and parent
support groups which include child abuse and
neglect prevention techniques.
(E) Support services, including, where
appropriate, transportation services.
(F) Where appropriate, referral of other
family members to related services such as job
training.
(G) Aftercare services, including continued
support through parent groups and home visits.
(d) Training for Providers of Services to Children and
Families.--The Secretary may make a grant under subsection (a)
for the training of health, substance abuse and mental health
professionals and other providers of services to children and
families through youth service agencies, family social
services, child care providers, Head Start, schools and after-
school programs, early childhood development programs,
community-based family resource centers, the criminal justice
system, and other providers of services to children and
families. Such training shall be to assist professionals in
recognizing the drug and alcohol problems of their clients and
to enhance their skills in identifying and understanding the
nature of substance abuse, and obtaining substance abuse early
intervention, prevention and treatment resources.
(e) Eligible Entities.--The Secretary shall distribute the
grants through the following types of entities:
(1) Alcohol and drug early intervention, prevention
or treatment programs, especially those providing
treatment to pregnant women and mothers and their
children.
(2) Public or nonprofit private entities that
provide health or social services to disadvantaged
populations, and that have--
(A) expertise in applying the services to
the particular problems of substance abusers
and the children of substance abusers; or
(B) an affiliation or contractual
relationship with one or more substance abuse
treatment programs or pediatric health or
mental health providers and family mental
health providers.
(3) Consortia of public or nonprofit private
entities that include at least one substance abuse
treatment program.
(4) Indian tribes.
(f) Federal Share.--The Federal share of a program carried
out under subsection (a) shall be 90 percent. The Secretary
shall accept the value of in-kind contributions, including
facilities and personnel, made by the grant recipient as a part
or all of the non-Federal share of grants.
(g) Restrictions on Use of Grant.--The Secretary may make a
grant under subsection (a) only if the applicant involved
agrees that the grant will not be expended--
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of
services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other than minor
remodeling) any building or other facility, or purchase
major medical equipment;
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds; or
(5) to provide financial assistance to any entity
other than a public or nonprofit private entity.
(h) Submission to Secretary of Certain Information.--The
Secretary may make a grant under subsection (a) only if the
applicant involved submits to the Secretary--
(1) a description of the population that is to
receive services under this section and a description
of such services that are to be provided and measurable
goals and objectives;
(2) a description of the mechanism that will be
used to involve the local public agencies responsible
for health, including maternal and child health \1\
mental health, child welfare, education, juvenile
justice, developmental disabilities, and substance
abuse in planning and providing services under this
section, as well as evidence that the proposal has been
coordinated with the State agencies responsible for
administering those programs, the State agency
responsible for administering alcohol and drug
programs, the State lead agency, and the State
Interagency Coordinating Council under part H of the
Individuals with Disabilities Education Act; and; \2\
---------------------------------------------------------------------------
\1\ The lack of a comma would be so in law. See section
3106(e)(1)(A) of Public Law 106-310 (114 Stat. 1177).
\2\ The superfluous semicolon would be so in law. See section
3106(e)(1)(C) of Public Law 106-310 (114 Stat. 1177).
---------------------------------------------------------------------------
(3) such other information as the Secretary
determines to be appropriate.
(i) Reports to Secretary.--The Secretary may make a grant
under subsection (a) only if the applicant involved agrees that
for each fiscal year for which the applicant receives such a
grant the applicant, in accordance with uniform standards
developed by the Secretary, will submit to the Secretary a
report containing--
(1) a description of specific services and
activities provided under the grant;
(2) information regarding progress toward meeting
the program's stated goals and objectives;
(3) information concerning the extent of use of
services provided under the grant, including the number
of referrals to related services and information on
other programs or services accessed by children,
parents, and other caretakers;
(4) information concerning the extent to which
parents were able to access and receive treatment for
alcohol and drug abuse and sustain participation in
treatment over time until the provider and the
individual receiving treatment agree to end such
treatment, and the extent to which parents re-enter
treatment after the successful or unsuccessful
termination of treatment;
(5) information concerning the costs of the
services provided and the source of financing for
health care services;
(6) information concerning--
(A) the number and characteristics of
families, parents, and children served,
including a description of the type and
severity of childhood disabilities, and an
analysis of the number of children served by
age;
(B) the number of children served who
remained with their parents during the period
in which entities provided services under this
section; and
(C) the number of case workers or other
professionals trained to identify and address
substance abuse issues.
(7) information on hospitalization or emergency
room use by the family members participating in the
program; and
(8) such other information as the Secretary
determines to be appropriate.
(j) Requirement of Application.--The Secretary may make any
grant under subsection (a) only if--
(1) an application for the grant is submitted to
the Secretary;
(2) the application contains the agreements
required in this section and the information required
in subsection (h); and
(3) the application is in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this section.
(k) Evaluations.--The Secretary shall periodically conduct
evaluations to determine the effectiveness of programs
supported under subsection (a)--
(1) in reducing the incidence of alcohol and drug
abuse among substance abusers participating in the
programs;
(2) in preventing adverse health conditions in
children of substance abusers;
(3) in promoting better utilization of health and
developmental services and improving the health,
developmental, and psychological status of children
receiving services under the program; and
(4) in improving parental and family functioning,
including increased participation in work or
employment-related activities and decreased
participation in welfare programs.
(l) Report to Congress.--Not later than 2 years after the
date on which amounts are first appropriated under subjection
(o), the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, a report
that contains a description of programs carried out under this
section. At a minimum, the report shall contain--
(1) information concerning the number and type of
programs receiving grants;
(2) information concerning the type and use of
services offered; and
(3) information concerning--
(A) the number and characteristics of
families, parents, and children served; and
(B) the number of children served who
remained with their parents during or after the
period in which entities provided services
under this section. \1\
---------------------------------------------------------------------------
\1\ The period at the end of subparagraph (B), and the semicolon at
the end of paragraph (3), would be so in law. See section 3106(h) of
Public Law 106-310 (114 Stat. 1178). The period probably should be a
semicolon, and the semicolon probably should be a period.
---------------------------------------------------------------------------
analyzed by the type of entity described in subsection
(d) \2\ that provided services; \3\
---------------------------------------------------------------------------
\2\ The reference to subsection (d) probably should be a reference
to subsection (e). Section 3106(l) of Public Law 106-310 (114 Stat.
1178) would redesignate subsection (d) as subsection (e) and make
conforming changes in cross-references. One of the conforming changes
would be to subsection (m), and would strike ``(d)'' and insert
``(e)''. The reference to subsection (d) appears in subsection (l),
however, not subsection (m).
\3\ See footnote for subsection (l)(3)(B).
---------------------------------------------------------------------------
(m) Data Collection.--The Secretary shall periodically
collect and report on information concerning the numbers of
children in substance abusing families, including information
on the age, gender and ethnicity of the children, the
composition and income of the family, and the source of health
care finances. The periodic report shall include a quantitative
estimate of the prevalence of alcohol and drug problems in
families involved in the child welfare system, the barriers to
treatment and prevention services facing these families, and
policy recommendations for removing the identified barriers,
including training for child welfare workers.
(n) Definitions.--For purposes of this section:
(1) The term ``caretaker'', with respect to a child
of a substance abuser, means any individual acting in a
parental role regarding the child (including any birth
parent, foster parent, adoptive parent, relative of
such a child, or other individual acting in such a
role).
(2) The term ``children of substance abusers''
means--
(A) children who have lived or are living
in a household with a substance abuser who is
acting in a parental role regarding the
children; and
(B) children who have been prenatally
exposed to alcohol or other drugs.
(3) The term ``Indian tribe'' means any tribe,
band, nation, or other organized group or community of
Indians, including any Alaska Native village (as
defined in, or established pursuant to, the Alaska
Native Claims Settlement Act), that is recognized as
eligible for the special programs and services provided
by the United States to Indians because of their status
as Indians.
(4) The term ``public or nonprofit private entities
that provide health or social services to disadvantaged
populations'' includes community-based organizations,
local public health departments, community action
agencies, hospitals, community health centers, child
welfare agencies, developmental disabilities service
providers, and family resource and support programs.
(5) The term ``substance abuse'' means the abuse of
alcohol or other drugs.
(o) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $50,000,000 for fiscal year 2001, and such sums as
may be necessary for each of fiscal years 2002 and 2003.
=======================================================================
Part M--National Program of Cancer Registries
SEC. 399B. [280E] NATIONAL PROGRAM OF CANCER REGISTRIES.
(a) In General.--
(1) Statewide cancer registries.--The Secretary,
acting through the Director of the Centers for Disease
Control, may make grants to States, or may make grants
or enter into contracts with academic or nonprofit
organizations designated by the State to operate the
State's cancer registry in lieu of making a grant
directly to the State, to support the operation of
population-based, statewide registries to collect, for
each condition specified in paragraph (2)(A), data
concerning--
(A) demographic information about each case
of cancer;
(B) information on the industrial or
occupational history of the individuals with
the cancers, to the extent such information is
available from the same record;
(C) administrative information, including
date of diagnosis and source of information;
(D) pathological data characterizing the
cancer, including the cancer site, stage of
disease (pursuant to Staging Guide), incidence,
and type of treatment; and
(E) other elements determined appropriate
by the Secretary.
(2) Cancer; benign brain-related tumors.--
(A) In general.--For purposes of paragraph
(1), the conditions referred to in this
paragraph are the following:
(i) Each form of in-situ and
invasive cancer (with the exception of
basal cell and squamous cell carcinoma
of the skin), including malignant
brain-related tumors.
(ii) Benign brain-related tumors.
(B) Brain-related tumor.--For purposes of
subparagraph (A):
(i) The term ``brain-related
tumor'' means a listed primary tumor
(whether malignant or benign) occurring
in any of the following sites:
(I) The brain, meninges,
spinal cord, cauda equina, a
cranial nerve or nerves, or any
other part of the central
nervous system.
(II) The pituitary gland,
pineal gland, or
craniopharyngeal duct.
(ii) The term ``listed'', with
respect to a primary tumor, means a
primary tumor that is listed in the
International Classification of
Diseases for Oncology (commonly
referred to as the ICD-O).
(iii) The term ``International
Classification of Diseases for
Oncology'' means a classification
system that includes topography (site)
information and histology (cell type
information) developed by the World
Health Organization, in collaboration
with international centers, to promote
international comparability in the
collection, classification, processing,
and presentation of cancer statistics.
The ICD-O system is a supplement to the
International Statistical
Classification of Diseases and Related
Health Problems (commonly known as the
ICD) and is the standard coding system
used by cancer registries worldwide.
Such term includes any modification
made to such system for purposes of the
United States. Such term further
includes any published classification
system that is internationally
recognized as a successor to the
classification system referred to in
the first sentence of this clause.
(C) Statewide cancer registry.--References
in this section to cancer registries shall be
considered to be references to registries
described in this subsection.
(b) Matching Funds.--
(1) In general.--The Secretary may make a grant
under subsection (a) only if the State, or the academic
or nonprofit private organization designated by the
State to operate the cancer registry of the State,
involved agrees, with respect to the costs of the
program, to make available (directly or through
donations from public or private entities) non-Federal
contributions toward such costs in an amount that is
not less than 25 percent of such costs or $1 for every
$3 of Federal funds provided in the grant.
(2) Determination of amount of non-federal
contribution; maintenance of effort.--
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or
services. Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of such non-Federal contributions.
(B) With respect to a State in which the
purpose described in subsection (a) is to be
carried out, the Secretary, in making a
determination of the amount of non-Federal
contributions provided under paragraph (1), may
include only such contributions as are in
excess of the amount of such contributions made
by the State toward the collection of data on
cancer for the fiscal year preceding the first
year for which a grant under subsection (a) is
made with respect to the State. The Secretary
may decrease the amount of non-Federal
contributions that otherwise would have been
required by this subsection in those cases in
which the State can demonstrate that decreasing
such amount is appropriate because of financial
hardship.
(c) Eligibility for Grants.--
(1) In general.--No grant shall be made by the
Secretary under subsection (a) unless an application
has been submitted to, and approved by, the Secretary.
Such application shall be in such form, submitted in
such a manner, and be accompanied by such information,
as the Secretary may specify. No such application may
be approved unless it contains assurances that the
applicant will use the funds provided only for the
purposes specified in the approved application and in
accordance with the requirements of this section, that
the application will establish such fiscal control and
fund accounting procedures as may be necessary to
assure proper disbursement and accounting of Federal
funds paid to the applicant under subsection (a) of
this section, and that the applicant will comply with
the peer review requirements under sections 491 and
492.
(2) Assurances.--Each applicant, prior to receiving
Federal funds under subsection (a), shall provide
assurances satisfactory to the Secretary that the
applicant will--
(A) provide for the establishment of a
registry in accordance with subsection (a);
(B) comply with appropriate standards of
completeness, timeliness, and quality of
population-based cancer registry data;
(C) provide for the annual publication of
reports of cancer data under subsection (a);
and
(D) provide for the authorization under
State law of the statewide cancer registry,
including promulgation of regulations
providing--
(i) a means to assure complete
reporting of cancer cases (as described
in subsection (a)) to the statewide
cancer registry by hospitals or other
facilities providing screening,
diagnostic or therapeutic services to
patients with respect to cancer;
(ii) a means to assure the complete
reporting of cancer cases (as defined
in subsection (a)) to the statewide
cancer registry by physicians,
surgeons, and all other health care
practitioners diagnosing or providing
treatment for cancer patients, except
for cases directly referred to or
previously admitted to a hospital or
other facility providing screening,
diagnostic or therapeutic services to
patients in that State and reported by
those facilities;
(iii) a means for the statewide
cancer registry to access all records
of physicians and surgeons, hospitals,
outpatient clinics, nursing homes, and
all other facilities, individuals, or
agencies providing such services to
patients which would identify cases of
cancer or would establish
characteristics of the cancer,
treatment of the cancer, or medical
status of any identified patient;
(iv) for the reporting of cancer
case data to the statewide cancer
registry in such a format, with such
data elements, and in accordance with
such standards of quality timeliness
and completeness, as may be established
by the Secretary;
(v) for the protection of the
confidentiality of all cancer case data
reported to the statewide cancer
registry, including a prohibition on
disclosure to any person of information
reported to the statewide cancer
registry that identifies, or could lead
to the identification of, an individual
cancer patient, except for disclosure
to other State cancer registries and
local and State health officers;
(vi) for a means by which
confidential case data may in
accordance with State law be disclosed
to cancer researchers for the purposes
of cancer prevention, control and
research;
(vii) for the authorization or the
conduct, by the statewide cancer
registry or other persons and
organizations, of studies utilizing
statewide cancer registry data,
including studies of the sources and
causes of cancer, evaluations of the
cost, quality, efficacy, and
appropriateness of diagnostic,
therapeutic, rehabilitative, and
preventative services and programs
relating to cancer, and any other
clinical, epidemiological, or other
cancer research; and
(viii) for protection for
individuals complying with the law,
including provisions specifying that no
person shall be held liable in any
civil action with respect to a cancer
case report provided to the statewide
cancer registry, or with respect to
access to cancer case information
provided to the statewide cancer
registry.
(d) Relationship to Certain Programs.--
(1) In general.--This section may not be construed
to act as a replacement for or diminishment of the
program carried out by the Director of the National
Cancer Institute and designated by such Director as the
Surveillance, Epidemiology, and End Results Program
(SEER).
(2) Supplanting of activities.--In areas where both
such programs exist, the Secretary shall ensure that
SEER support is not supplanted and that any additional
activities are consistent with the guidelines provided
for in subsection (c)(2) (C) and (D) and are
appropriately coordinated with the existing SEER
program.
(3) Transfer of responsibility.--The Secretary may
not transfer administration responsibility for such
SEER program from such Director.
(4) Coordination.--To encourage the greatest
possible efficiency and effectiveness of Federally
supported efforts with respect to the activities
described in this subsection, the Secretary shall take
steps to assure the appropriate coordination of
programs supported under this part with existing
Federally supported cancer registry programs.
(e) Requirement Regarding Certain Study on Breast Cancer.--
In the case of a grant under subsection (a) to any State
specified in subsection (b) of section 399E, the Secretary may
establish such conditions regarding the receipt of the grant as
the Secretary determines are necessary to facilitate the
collection of data for the study carried out under such
section.
SEC. 399C. [280E-1] PLANNING GRANTS REGARDING REGISTRIES.
(a) In General.--
(1) States.--The Secretary, acting through the
Director of the Centers for Disease Control, may make
grants to States for the purpose of developing plans
that meet the assurances required by the Secretary
under section 399B(c)(2).
(2) Other entities.--For the purpose described in
paragraph (1), the Secretary may make grants to public
entities other than States and to nonprofit private
entities. Such a grant may be made to an entity only if
the State in which the purpose is to be carried out has
certified that the State approves the entity as
qualified to carry out the purpose.
(b) Application.--The Secretary may make a grant under
subsection (a) only if an application for the grant is
submitted to the Secretary, the application contains the
certification required in subsection (a)(2) (if the application
is for a grant under such subsection), and the application is
in such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section.
SEC. 399D. [280E-2] TECHNICAL ASSISTANCE IN OPERATIONS OF STATEWIDE
CANCER REGISTRIES.
The Secretary, acting through the Director of the Centers
for Disease Control, may, directly or through grants and
contracts, or both, provide technical assistance to the States
in the establishment and operation of statewide registries,
including assistance in the development of model legislation
for statewide cancer registries and assistance in establishing
a computerized reporting and data processing system.
SEC. 399E. [280E-3] STUDY IN CERTAIN STATES TO DETERMINE THE FACTORS
CONTRIBUTING TO THE ELEVATED BREAST CANCER
MORTALITY RATES.
(a) In General.--Subject to subsections (c) and (d), the
Secretary, acting through the Director of the National Cancer
Institute, shall conduct a study for the purpose of determining
the factors contributing to the fact that breast cancer
mortality rates in the States specified in subsection (b) are
elevated compared to rates in other States.
(b) Relevant States.--The States referred to in subsection
(a) are Connecticut, Delaware, Maryland, Massachusetts, New
Hampshire, New Jersey, New York, Rhode Island, Vermont, and the
District of Columbia.
(c) Cooperation of State.--The Secretary may conduct the
study required in subsection (a) in a State only if the State
agrees to cooperate with the Secretary in the conduct of the
study, including providing information from any registry
operated by the State pursuant to section 399B(a).
(d) Planning, Commencement, and Duration.--The Secretary
shall, during each of the fiscal years 1993 and 1994, develop a
plan for conducting the study required in subsection (a). The
study shall be initiated by the Secretary not later than fiscal
year 1994, and the collection of data under the study may
continue through fiscal year 1998.
SEC. 399E-1. [280E-3A] NATIONAL CHILDHOOD CANCER REGISTRY.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall award
a grant to enhance and expand infrastructure to track the
epidemiology of pediatric cancer into a comprehensive
nationwide registry of actual occurrences of pediatric cancer.
Such registry shall be updated to include an actual occurrence
within weeks of the date of such occurrence.
(b) Informed Consent and Privacy Requirements and
Coordination With Existing Programs.--The registry established
pursuant to subsection (a) shall be subject to section 552a of
title 5, United States Code, the regulations promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, applicable Federal and State
informed consent regulations, any other applicable Federal and
State laws relating to the privacy of patient information, and
section 399B(d)(4) of this Act.
SEC. 399F. [280E-4] AUTHORIZATION OF APPROPRIATIONS.
(a) Registries.--For the purpose of carrying out this part
(other than section 399E-1), there are authorized to be
appropriated $30,000,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 through
2003. Of the amounts appropriated under the preceding sentence
for any such fiscal year, the Secretary may obligate not more
than 25 percent for carrying out section 399C, and not more
than 10 percent may be expended for assessing the accuracy,
completeness and quality of data collected, and not more than
10 percent of which is to be expended under section 399D.
(b) Breast Cancer Study.--Of the amounts appropriated for
the National Cancer Institute under subpart 1 of part C of
title IV for any fiscal year in which the study required in
section 399K \1\ is being carried out, the Secretary shall
expend not less than $1,000,000 for the study.
---------------------------------------------------------------------------
\1\ Probably should be a reference to section 399E. Section
502(2)(D)(iii) of Public Law 106-310 (114 Stat. 1115) provides that
subsection (b) above is amended by striking ``subsection 399K'' and
inserting ``section 399E''. The amendment cannot be executed because
the term to be struck does not appear in subsection (b). (Compare
``subsection 399K'' and ``section 399K''.)
---------------------------------------------------------------------------
Part N--National Foundation for the Centers for Disease Control and
Prevention
SEC. 399G. [280E-11] ESTABLISHMENT AND DUTIES OF FOUNDATION.
(a) In General.--There shall be established in accordance
with this section a nonprofit private corporation to be known
as the National Foundation for the Centers for Disease Control
and Prevention (in this part referred to as the
``Foundation''). The Foundation shall not be an agency or
instrumentality of the Federal Government, and officers,
employees, and members of the board of the Foundation shall not
be officers or employees of the Federal Government.
(b) Purpose of Foundation.--The purpose of the Foundation
shall be to support and carry out activities for the prevention
and control of diseases, disorders, injuries, and disabilities,
and for promotion of public health.
(c) Endowment Fund.--
(1) In general.--In carrying out subsection (b),
the Foundation shall establish a fund for providing
endowments for positions that are associated with the
Centers for Disease Control and Prevention and
dedicated to the purpose described in such subsection.
Subject to subsection (f)(1)(B), the fund shall consist
of such donations as may be provided by non-Federal
entities and such non-Federal assets of the Foundation
(including earnings of the Foundation and the fund) as
the Foundation may elect to transfer to the fund.
(2) Authorized expenditures of fund.--The provision
of endowments under paragraph (1) shall be the
exclusive function of the fund established under such
paragraph. Such endowments may be expended only for the
compensation of individuals holding the positions, for
staff, equipment, quarters, travel, and other
expenditures that are appropriate in supporting the
positions, and for recruiting individuals to hold the
positions endowed by the fund.
(d) Certain Activities of Foundation.--In carrying out
subsection (b), the Foundation may provide for the following
with respect to the purpose described in such subsection:
(1) Programs of fellowships for State and local
public health officials to work and study in
association with the Centers for Disease Control and
Prevention.
(2) Programs of international arrangements to
provide opportunities for public health officials of
other countries to serve in public health capacities in
the United States in association with the Centers for
Disease Control and Prevention or elsewhere, or
opportunities for employees of such Centers (or other
public health officials in the United States) to serve
in such capacities in other countries, or both.
(3) Studies, projects, and research (which may
include applied research on the effectiveness of
prevention activities, demonstration projects, and
programs and projects involving international, Federal,
State, and local governments).
(4) Forums for government officials and appropriate
private entities to exchange information. Participants
in such forums may include institutions of higher
education and appropriate international organizations.
(5) Meetings, conferences, courses, and training
workshops.
(6) Programs to improve the collection and analysis
of data on the health status of various populations.
(7) Programs for writing, editing, printing, and
publishing of books and other materials.
(8) Other activities to carry out the purpose
described in subsection (b).
(e) General Structure of Foundation; Nonprofit Status.--
(1) Board of directors.--The Foundation shall have
a board of directors (in this part referred to as the
``Board''), which shall be established and conducted in
accordance with subsection (f). The Board shall
establish the general policies of the Foundation for
carrying out subsection (b), including the
establishment of the bylaws of the Foundation.
(2) Executive director.--The Foundation shall have
an executive director (in this part referred to as the
``Director''), who shall be appointed by the Board, who
shall serve at the pleasure of the Board, and for whom
the Board shall establish the rate of compensation.
Subject to compliance with the policies and bylaws
established by the Board pursuant to paragraph (1), the
Director shall be responsible for the daily operations
of the Foundation in carrying out subsection (b).
(3) Nonprofit status.--In carrying out subsection
(b), the Board shall establish such policies and bylaws
under paragraph (1), and the Director shall carry out
such activities under paragraph (2), as may be
necessary to ensure that the Foundation maintains
status as an organization that--
(A) is described in subsection (c)(3) of
section 501 of the Internal Revenue Code of
1986; and
(B) is, under subsection (a) of such
section, exempt from taxation.
(f) Board of Directors.--
(1) Certain bylaws.--
(A) In establishing bylaws under subsection
(e)(1), the Board shall ensure that the bylaws
of the Foundation include bylaws for the
following:
(i) Policies for the selection of
the officers, employees, agents, and
contractors of the Foundation.
(ii) Policies, including ethical
standards, for the acceptance and
disposition of donations to the
Foundation and for the disposition of
the assets of the Foundation.
(iii) Policies for the conduct of
the general operations of the
Foundation.
(iv) Policies for writing, editing,
printing, and publishing of books and
other materials, and the acquisition of
patents and licenses for devices and
procedures developed by the Foundation.
(B) In establishing bylaws under subsection
(e)(1), the Board shall ensure that the bylaws
of the Foundation (and activities carried out
under the bylaws) do not--
(i) reflect unfavorably upon the
ability of the Foundation, or the
Centers for Disease Control and
Prevention, to carry out its
responsibilities or official duties in
a fair and objective manner; or
(ii) compromise, or appear to
compromise, the integrity of any
governmental program or any officer or
employee involved in such program.
(2) Composition.--
(A) Subject to subparagraph (B), the Board
shall be composed of 7 individuals, appointed
in accordance with paragraph (4), who
collectively possess education or experience
appropriate for representing the general field
of public health, the general field of
international health, and the general public.
Each such individual shall be a voting member
of the Board.
(B) The Board may, through amendments to
the bylaws of the Foundation, provide that the
number of members of the Board shall be a
greater number than the number specified in
subparagraph (A).
(3) Chair.--The Board shall, from among the members
of the Board, designate an individual to serve as the
chair of the Board (in this subsection referred to as
the ``Chair'').
(4) Appointments, vacancies, and terms.--Subject to
subsection (j) (regarding the initial membership of the
Board), the following shall apply to the Board:
(A) Any vacancy in the membership of the
Board shall be filled by appointment by the
Board, after consideration of suggestions made
by the Chair and the Director regarding the
appointments. Any such vacancy shall be filled
not later than the expiration of the 180-day
period beginning on the date on which the
vacancy occurs.
(B) The term of office of each member of
the Board appointed under subparagraph (A)
shall be 5 years. A member of the Board may
continue to serve after the expiration of the
term of the member until the expiration of the
180-day period beginning on the date on which
the term of the member expires.
(C) A vacancy in the membership of the
Board shall not affect the power of the Board
to carry out the duties of the Board. If a
member of the Board does not serve the full
term applicable under subparagraph (B), the
individual appointed to fill the resulting
vacancy shall be appointed for the remainder of
the term of the predecessor of the individual.
(5) Compensation.--Members of the Board may not
receive compensation for service on the Board. The
members may be reimbursed for travel, subsistence, and
other necessary expenses incurred in carrying out the
duties of the Board.
(g) Certain Responsibilities of Executive Director.--In
carrying out subsection (e)(2), the Director shall carry out
the following functions:
(1) Hire, promote, compensate, and discharge
officers and employees of the Foundation, and define
the duties of the officers and employees.
(2) Accept and administer donations to the
Foundation, and administer the assets of the
Foundation.
(3) Establish a process for the selection of
candidates for holding endowed positions under
subsection (c).
(4) Enter into such financial agreements as are
appropriate in carrying out the activities of the
Foundation.
(5) Take such action as may be necessary to acquire
patents and licenses for devices and procedures
developed by the Foundation and the employees of the
Foundation.
(6) Adopt, alter, and use a corporate seal, which
shall be judicially noticed.
(7) Commence and respond to judicial proceedings in
the name of the Foundation.
(8) Other functions that are appropriate in the
determination of the Director.
(h) General Provisions.--
(1) Authority for accepting funds.--The Director of
the Centers for Disease Control and Prevention may
accept and utilize, on behalf of the Federal
Government, any gift, donation, bequest, or devise of
real or personal property from the Foundation for the
purpose of aiding or facilitating the work of such
Centers. Funds may be accepted and utilized by such
Director under the preceding sentence without regard to
whether the funds are designated as general-purpose
funds or special-purpose funds.
(2) Authority for acceptance of voluntary
services.--
(A) The Director of the Centers for Disease
Control and Prevention may accept, on behalf of
the Federal Government, any voluntary services
provided to such Centers by the Foundation for
the purpose of aiding or facilitating the work
of such Centers. In the case of an individual,
such Director may accept the services provided
under the preceding sentence by the individual
until such time as the private funding for such
individual ends.
(B) The limitation established in
subparagraph (A) regarding the period of time
in which services may be accepted applies to
each individual who is not an employee of the
Federal Government and who serves in
association with the Centers for Disease
Control and Prevention pursuant to financial
support from the Foundation.
(3) Administrative control.--No officer, employee,
or member of the Board of the Foundation may exercise
any administrative or managerial control over any
Federal employee.
(4) Applicability of certain standards to non-
federal employees.--In the case of any individual who
is not an employee of the Federal Government and who
serves in association with the Centers for Disease
Control and Prevention pursuant to financial support
from the Foundation, the Foundation shall negotiate a
memorandum of understanding with the individual and the
Director of the Centers for Disease Control and
Prevention specifying that the individual--
(A) shall be subject to the ethical and
procedural standards regulating Federal
employment, scientific investigation, and
research findings (including publications and
patents) that are required of individuals
employed by the Centers for Disease Control and
Prevention, including standards under this Act,
the Ethics in Government Act, and the
Technology Transfer Act; and
(B) shall be subject to such ethical and
procedural standards under chapter 11 of title
18, United States Code (relating to conflicts
of interest), as the Director of such Centers
determines is appropriate, except such
memorandum may not provide that the individual
shall be subject to the standards of section
209 of such chapter.
(5) Financial conflicts of interest.--Any
individual who is an officer, employee, or member of
the Board of the Foundation may not directly or
indirectly participate in the consideration or
determination by the Foundation of any question
affecting--
(A) any direct or indirect financial
interest of the individual; or
(B) any direct or indirect financial
interest of any business organization or other
entity of which the individual is an officer or
employee or in which the individual has a
direct or indirect financial interest.
(6) Audits; availability of records.--The
Foundation shall--
(A) provide for biennial audits of the
financial condition of the Foundation; and
(B) make such audits, and all other
records, documents, and other papers of the
Foundation, available to the Secretary and the
Comptroller General of the United States for
examination or audit.
(7) Reports.--
(A) Not later than February 1 of each
fiscal year, the Foundation shall publish a
report describing the activities of the
Foundation during the preceding fiscal year.
Each such report shall include for the fiscal
year involved a comprehensive statement of the
operations, activities, financial condition,
and accomplishments of the Foundation,
including an accounting of the use of amounts
provided for under subsection (i).
(B) With respect to the financial condition
of the Foundation, each report under
subparagraph (A) shall include the source, and
a description of, all gifts to the Foundation
of real or personal property, and the source
and amount of all gifts to the Foundation of
money. Each such report shall include a
specification of any restrictions on the
purposes for which gifts to the Foundation may
be used.
(C) The Foundation shall make copies of
each report submitted under subparagraph (A)
available--
(i) for public inspection, and
shall upon request provide a copy of
the report to any individual for a
charge not to exceed the cost of
providing the copy; and
(ii) to the appropriate committees
of Congress.
(8) Liaison from centers for disease control and
prevention.--The Director of the Centers for Disease
Control and Prevention shall serve as the liaison
representative of such Centers to the Board and the
Foundation.
(i) Federal Funding.--
(1) Authority for annual grants.--
(A) The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall--
(i) for fiscal year 1993, make a
grant to an entity described in
subsection (j)(9) (relating to the
establishment of a committee to
establish the Foundation);
(ii) for fiscal year 1994, make a
grant to the committee established
under such subsection, or if the
Foundation has been established, to the
Foundation; and
(iii) for fiscal year 1995 and each
subsequent fiscal year, make a grant to
the Foundation.
(B) A grant under subparagraph (A) may be
expended--
(i) in the case of an entity
receiving the grant under subparagraph
(A)(i), only for the purpose of
carrying out the duties established in
subsection (j)(9) for the entity;
(ii) in the case of the committee
established under such subsection, only
for the purpose of carrying out the
duties established in subsection (j)
for the committee; and
(iii) in the case of the
Foundation, only for the purpose of the
administrative expenses of the
Foundation.
(C) A grant under subparagraph (A) may not
be expended to provide amounts for the fund
established under subsection (c).
(D) For the purposes described in
subparagraph (B)--
(i) any portion of the grant made
under subparagraph (A)(i) for fiscal
year 1993 that remains unobligated
after the entity receiving the grant
completes the duties established in
subsection (j)(9) for the entity shall
be available to the committee
established under such subsection; and
(ii) any portion of a grant under
subparagraph (A) made for fiscal year
1993 or 1994 that remains unobligated
after such committee completes the
duties established in such subsection
for the committee shall be available to
the Foundation.
(2) Funding for grants.--
(A) For the purpose of grants under
paragraph (1), there is authorized to be
appropriated $1,250,000 for each fiscal year.
(B) For the purpose of grants under
paragraph (1), the Secretary may for each
fiscal year make available not less than
$500,000, and not more than $1,250,000 from the
amounts appropriated for the fiscal year for
the programs of the Department of Health and
Human Services. Such amounts may be made
available without regard to whether amounts
have been appropriated under subparagraph (A).
(3) Certain restriction.--If the Foundation
receives Federal funds for the purpose of serving as a
fiscal intermediary between Federal agencies, the
Foundation may not receive such funds for the indirect
costs of carrying out such purpose in an amount
exceeding 10 percent of the direct costs of carrying
out such purpose. The preceding sentence may not be
construed as authorizing the expenditure of any grant
under paragraph (1) for such purpose.
(4) Support services.--The Director of the Centers
for Disease Control and Prevention may provide
facilities, utilities, and support services to the
Foundation if it is determined by the Director to be
advantageous to the programs of such Centers.
(j) Committee for Establishment of Foundation.--
(1) In general.--There shall be established in
accordance with this subsection a committee to carry
out the functions described in paragraph (2) (which
committee is referred to in this subsection as the
``Committee'').
(2) Functions.--The functions referred to in
paragraph (1) for the Committee are as follows:
(A) To carry out such activities as may be
necessary to incorporate the Foundation under
the laws of the State involved, including
serving as incorporators for the Foundation.
Such activities shall include ensuring that the
articles of incorporation for the Foundation
require that the Foundation be established and
operated in accordance with the applicable
provisions of this part (or any successor to
this part), including such provisions as may be
in effect pursuant to amendments enacted after
the date of the enactment of the Preventive
Health Amendments of 1992 \1\.
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\1\ Enacted October 27, 1992.
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(B) To ensure that the Foundation qualifies
for and maintains the status described in
subsection (e)(3) (regarding taxation).
(C) To establish the general policies and
initial bylaws of the Foundation, which bylaws
shall include the bylaws described in
subsections (e)(3) and (f)(1).
(D) To provide for the initial operation of
the Foundation, including providing for
quarters, equipment, and staff.
(E) To appoint the initial members of the
Board in accordance with the requirements
established in subsection (f)(2)(A) for the
composition of the Board, and in accordance
with such other qualifications as the Committee
may determine to be appropriate regarding such
composition. Of the members so appointed--
(i) 2 shall be appointed to serve
for a term of 3 years;
(ii) 2 shall be appointed to serve
for a term of 4 years; and
(iii) 3 shall be appointed to serve
for a term of 5 years.
(3) Completion of functions of committee; initial
meeting of board.--
(A) The Committee shall complete the
functions required in paragraph (1) not later
than September 30, 1994. The Committee shall
terminate upon the expiration of the 30-day
period beginning on the date on which the
Secretary determines that the functions have
been completed.
(B) The initial meeting of the Board shall
be held not later than November 1, 1994.
(4) Composition.--The Committee shall be composed
of 5 members, each of whom shall be a voting member. Of
the members of the Committee--
(A) no fewer than 2 shall have broad,
general experience in public health; and
(B) no fewer than 2 shall have broad,
general experience in nonprofit private
organizations (without regard to whether the
individuals have experience in public health).
(5) Chair.--The Committee shall, from among the
members of the Committee, designate an individual to
serve as the chair of the Committee.
(6) Terms; vacancies.--The term of members of the
Committee shall be for the duration of the Committee. A
vacancy in the membership of the Committee shall not
affect the power of the Committee to carry out the
duties of the Committee. If a member of the Committee
does not serve the full term, the individual appointed
to fill the resulting vacancy shall be appointed for
the remainder of the term of the predecessor of the
individual.
(7) Compensation.--Members of the Committee may not
receive compensation for service on the Committee.
Members of the Committee may be reimbursed for travel,
subsistence, and other necessary expenses incurred in
carrying out the duties of the Committee.
(8) Committee support.--The Director of the Centers
for Disease Control and Prevention may, from amounts
available to the Director for the general
administration of such Centers, provide staff and
financial support to assist the Committee with carrying
out the functions described in paragraph (2). In
providing such staff and support, the Director may both
detail employees and contract for assistance.
(9) Grant for establishment of committee.--
(A) With respect to a grant under paragraph
(1)(A)(i) of subsection (i) for fiscal year
1993, an entity described in this paragraph is
a private nonprofit entity with significant
experience in domestic and international issues
of public health. Not later than 180 days after
the date of the enactment of the Preventive
Health Amendments of 1992 \1\, the Secretary
shall make the grant to such an entity (subject
to the availability of funds under paragraph
(2) of such subsection).
---------------------------------------------------------------------------
\1\ Enacted October 27, 1992.
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(B) The grant referred to in subparagraph
(A) may be made to an entity only if the entity
agrees that--
(i) the entity will establish a
committee that is composed in
accordance with paragraph (4); and
(ii) the entity will not select an
individual for membership on the
Committee unless the individual agrees
that the Committee will operate in
accordance with each of the provisions
of this subsection that relate to the
operation of the Committee.
(C) The Secretary may make a grant referred
to in subparagraph (A) only if the applicant
for the grant makes an agreement that the grant
will not be expended for any purpose other than
carrying out subparagraph (B). Such a grant may
be made only if an application for the grant is
submitted to the Secretary containing such
agreement, and the application is in such form,
is made in such manner, and contains such other
agreements and such assurances and information
as the Secretary determines to be necessary to
carry out this paragraph.
PART O--FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
SEC. 399H. [280F] ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION
AND SERVICES PROGRAM.
(a) Fetal Alcohol Syndrome Prevention, Intervention and
Services Delivery Program.--The Secretary shall establish a
comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect
prevention, intervention and services delivery program that
shall include--
(1) an education and public awareness program to
support, conduct, and evaluate the effectiveness of--
(A) educational programs targeting medical
schools, social and other supportive services,
educators and counselors and other service
providers in all phases of childhood
development, and other relevant service
providers, concerning the prevention,
identification, and provision of services for
children, adolescents and adults with Fetal
Alcohol Syndrome and Fetal Alcohol Effect;
(B) strategies to educate school-age
children, including pregnant and high risk
youth, concerning Fetal Alcohol Syndrome and
Fetal Alcohol Effect;
(C) public and community awareness programs
concerning Fetal Alcohol Syndrome and Fetal
Alcohol Effect; and
(D) strategies to coordinate information
and services across affected community
agencies, including agencies providing social
services such as foster care, adoption, and
social work, medical and mental health
services, and agencies involved in education,
vocational training and civil and criminal
justice;
(2) a prevention and diagnosis program to support
clinical studies, demonstrations and other research as
appropriate to--
(A) develop appropriate medical diagnostic
methods for identifying Fetal Alcohol Syndrome
and Fetal Alcohol Effect; and
(B) develop effective prevention services
and interventions for pregnant, alcohol-
dependent women; and
(3) an applied research program concerning
intervention and prevention to support and conduct
service demonstration projects, clinical studies and
other research models providing advocacy, educational
and vocational training, counseling, medical and mental
health, and other supportive services, as well as
models that integrate and coordinate such services,
that are aimed at the unique challenges facing
individuals with Fetal Alcohol Syndrome or Fetal
Alcohol Effect and their families.
(b) Grants and Technical Assistance.--The Secretary may
award grants, cooperative agreements and contracts and provide
technical assistance to eligible entities described in section
399I to carry out subsection (a).
(c) Dissemination of Criteria.--In carrying out this
section, the Secretary shall develop a procedure for
disseminating the Fetal Alcohol Syndrome and Fetal Alcohol
Effect diagnostic criteria developed pursuant to section 705 of
the ADAMHA Reorganization Act (42 U.S.C. 485n note) to health
care providers, educators, social workers, child welfare
workers, and other individuals.
(d) National Task Force.--
(1) In general.--The Secretary shall establish a
task force to be known as the National Task Force on
Fetal Alcohol Syndrome and Fetal Alcohol Effect
(referred to in this subsection as the ``Task Force'')
to foster coordination among all governmental agencies,
academic bodies and community groups that conduct or
support Fetal Alcohol Syndrome and Fetal Alcohol Effect
research, programs, and surveillance, and otherwise
meet the general needs of populations actually or
potentially impacted by Fetal Alcohol Syndrome and
Fetal Alcohol Effect.
(2) Membership.--The Task Force established
pursuant to paragraph (1) shall--
(A) be chaired by an individual to be
appointed by the Secretary and staffed by the
Administration; and
(B) include the Chairperson of the
Interagency Coordinating Committee on Fetal
Alcohol Syndrome of the Department of Health
and Human Services, individuals with Fetal
Alcohol Syndrome and Fetal Alcohol Effect, and
representatives from advocacy and research
organizations such as the Research Society on
Alcoholism, the FAS Family Resource Institute,
the National Organization of Fetal Alcohol
Syndrome, the Arc, the academic community, and
Federal, State and local government agencies
and offices.
(3) Functions.--The Task Force shall--
(A) advise Federal, State and local
programs and research concerning Fetal Alcohol
Syndrome and Fetal Alcohol Effect, including
programs and research concerning education and
public awareness for relevant service
providers, school-age children, women at-risk,
and the general public, medical diagnosis,
interventions for women at-risk of giving birth
to children with Fetal Alcohol Syndrome and
Fetal Alcohol Effect, and beneficial services
for individuals with Fetal Alcohol Syndrome and
Fetal Alcohol Effect and their families;
(B) coordinate its efforts with the
Interagency Coordinating Committee on Fetal
Alcohol Syndrome of the Department of Health
and Human Services; and
(C) report on a biennial basis to the
Secretary and relevant committees of Congress
on the current and planned activities of the
participating agencies.
(4) Time for appointment.--The members of the Task
Force shall be appointed by the Secretary not later
than 6 months after the date of enactment of this part.
SEC. 399I. [280F-1] ELIGIBILITY.
To be eligible to receive a grant, or enter into a
cooperative agreement or contract under this part, an entity
shall--
(1) be a State, Indian tribal government, local
government, scientific or academic institution, or
nonprofit organization; and
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
prescribe, including a description of the activities
that the entity intends to carry out using amounts
received under this part.
SEC. 399J. [280F-2] AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--There are authorized to be appropriated to
carry out this part, $27,000,000 for each of the fiscal years
1999 through 2003.
(b) Task Force.--From amounts appropriated for a fiscal
year under subsection (a), the Secretary may use not to exceed
$2,000,000 of such amounts for the operations of the National
Task Force under section 399H(d).
SEC. 399K. [280F-3] SUNSET PROVISION.
This part shall not apply on the date that is 7 years after
the date on which all members of the National Task Force have
been appointed under section 399H(d)(1).
PART P--ADDITIONAL PROGRAMS
SEC. 399L. [280G] CHILDREN'S ASTHMA TREATMENT GRANTS PROGRAM.
(a) Authority To Make Grants.--
(1) In general.--In addition to any other payments
made under this Act or title V of the Social Security
Act, the Secretary shall award grants to eligible
entities to carry out the following purposes:
(A) To provide access to quality medical
care for children who live in areas that have a
high prevalence of asthma and who lack access
to medical care.
(B) To provide on-site education to
parents, children, health care providers, and
medical teams to recognize the signs and
symptoms of asthma, and to train them in the
use of medications to treat asthma and prevent
its exacerbations.
(C) To decrease preventable trips to the
emergency room by making medication available
to individuals who have not previously had
access to treatment or education in the
management of asthma.
(D) To provide other services, such as
smoking cessation programs, home modification,
and other direct and support services that
ameliorate conditions that exacerbate or induce
asthma.
(2) Certain projects.--In making grants under
paragraph (1), the Secretary may make grants designed
to develop and expand the following projects:
(A) Projects to provide comprehensive
asthma services to children in accordance with
the guidelines of the National Asthma Education
and Prevention Program (through the National
Heart, Lung and Blood Institute), including
access to care and treatment for asthma in a
community-based setting.
(B) Projects to fully equip mobile health
care clinics that provide preventive asthma
care including diagnosis, physical
examinations, pharmacological therapy, skin
testing, peak flow meter testing, and other
asthma-related health care services.
(C) Projects to conduct validated asthma
management education programs for patients with
asthma and their families, including patient
education regarding asthma management, family
education on asthma management, and the
distribution of materials, including displays
and videos, to reinforce concepts presented by
medical teams.
(2) \1\ Award of grants.--
---------------------------------------------------------------------------
\1\So in law. There are two paragraphs (2) in subsection (a). The
second paragraph (2) and paragraph (3) probably should be redesignated
as paragraphs (3) and (4), respectively. See section 501 of Public Law
106-310 (114 Stat. 1113).
---------------------------------------------------------------------------
(A) Application.--
(i) In general.--An eligible entity
shall submit an application to the
Secretary for a grant under this
section in such form and manner as the
Secretary may require.
(ii) Required information.--An
application submitted under this
subparagraph shall include a plan for
the use of funds awarded under the
grant and such other information as the
Secretary may require.
(B) Requirement.--In awarding grants under
this section, the Secretary shall give
preference to eligible entities that
demonstrate that the activities to be carried
out under this section shall be in localities
within areas of known or suspected high
prevalence of childhood asthma or high asthma-
related mortality or high rate of
hospitalization or emergency room visits for
asthma (relative to the average asthma
prevalence rates and associated mortality rates
in the United States). Acceptable data sets to
demonstrate a high prevalence of childhood
asthma or high asthma-related mortality may
include data from Federal, State, or local
vital statistics, claims data under title XIX
or XXI of the Social Security Act, other public
health statistics or surveys, or other data
that the Secretary, in consultation with the
Director of the Centers for Disease Control and
Prevention, deems appropriate.
(3) Definition of eligible entity.--For purposes of
this section, the term ``eligible entity'' means a
public or nonprofit private entity (including a State
or political subdivision of a State), or a consortium
of any of such entities.
(b) Coordination With Other Children's Programs.--An
eligible entity shall identify in the plan submitted as part of
an application for a grant under this section how the entity
will coordinate operations and activities under the grant
with--
(1) other programs operated in the State that serve
children with asthma, including any such programs
operated under title V, XIX, or XXI of the Social
Security Act; and
(2) one or more of the following--
(A) the child welfare and foster care and
adoption assistance programs under parts B and
E of title IV of such Act;
(B) the head start program established
under the Head Start Act (42 U.S.C. 9831 et
seq.);
(C) the program of assistance under the
special supplemental nutrition program for
women, infants and children (WIC) under section
17 of the Child Nutrition Act of 1966 (42
U.S.C. 1786);
(D) local public and private elementary or
secondary schools; or
(E) public housing agencies, as defined in
section 3 of the United States Housing Act of
1937 (42 U.S.C. 1437a).
(c) Evaluation.--An eligible entity that receives a grant
under this section shall submit to the Secretary an evaluation
of the operations and activities carried out under the grant
that includes--
(1) a description of the health status outcomes of
children assisted under the grant;
(2) an assessment of the utilization of asthma-
related health care services as a result of activities
carried out under the grant;
(3) the collection, analysis, and reporting of
asthma data according to guidelines prescribed by the
Director of the Centers for Disease Control and
Prevention; and
(4) such other information as the Secretary may
require.
(d) Preference for States That Allow Students to Self-
Administer Medication to Treat Asthma and Anaphylaxis.-- \1\
---------------------------------------------------------------------------
\1\ Subsection (d) was added by section 3(a) of Public Law 108-377
(118 Stat. 2203), which was enacted October 30, 2004. Section 3(b) of
such Public Law provides as follows: ``The amendments made by this
section shall apply only with respect to grants made on or after the
date that is 9 months after the date of the enactment of this Act.''.
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(1) Preference.--The Secretary, in making any grant
under this section or any other grant that is asthma-
related (as determined by the Secretary) to a State,
shall give preference to any State that satisfies the
following:
(A) In general.--The State must require
that each public elementary school and
secondary school in that State will grant to
any student in the school an authorization for
the self-administration of medication to treat
that student's asthma or anaphylaxis, if--
(i) a health care practitioner
prescribed the medication for use by
the student during school hours and
instructed the student in the correct
and responsible use of the medication;
(ii) the student has demonstrated
to the health care practitioner (or
such practitioner's designee) and the
school nurse (if available) the skill
level necessary to use the medication
and any device that is necessary to
administer such medication as
prescribed;
(iii) the health care practitioner
formulates a written treatment plan for
managing asthma or anaphylaxis episodes
of the student and for medication use
by the student during school hours; and
(iv) the student's parent or
guardian has completed and submitted to
the school any written documentation
required by the school, including the
treatment plan formulated under clause
(iii) and other documents related to
liability.
(B) Scope.--An authorization granted under
subparagraph (A) must allow the student
involved to possess and use his or her
medication--
(i) while in school;
(ii) while at a school-sponsored
activity, such as a sporting event; and
(iii) in transit to or from school
or school-sponsored activities.
(C) Duration of authorization.--An
authorization granted under subparagraph (A)--
(i) must be effective only for the
same school and school year for which
it is granted; and
(ii) must be renewed by the parent
or guardian each subsequent school year
in accordance with this subsection.
(D) Backup medication.--The State must
require that backup medication, if provided by
a student's parent or guardian, be kept at a
student's school in a location to which the
student has immediate access in the event of an
asthma or anaphylaxis emergency.
(E) Maintenance of information.--The State
must require that information described in
subparagraphs (A)(iii) and (A)(iv) be kept on
file at the student's school in a location
easily accessible in the event of an asthma or
anaphylaxis emergency.
(2) Rule of construction.--Nothing in this
subsection creates a cause of action or in any other
way increases or diminishes the liability of any person
under any other law.
(3) Definitions.--For purposes of this subsection:
(A) The terms ``elementary school'' and
``secondary school'' have the meaning given to
those terms in section 9101 of the Elementary
and Secondary Education Act of 1965.
(B) The term ``health care practitioner''
means a person authorized under law to
prescribe drugs subject to section 503(b) of
the Federal Food, Drug, and Cosmetic Act.
(C) The term ``medication'' means a drug as
that term is defined in section 201 of the
Federal Food, Drug, and Cosmetic Act and
includes inhaled bronchodilators and auto-
injectable epinephrine.
(D) The term ``self-administration'' means
a student's discretionary use of his or her
prescribed asthma or anaphylaxis medication,
pursuant to a prescription or written direction
from a health care practitioner.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
SEC. 399M. [280G-1] EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING
HEARING LOSS IN NEWBORNS AND INFANTS.
(a) Statewide Newborn and Infant Hearing Screening,
Evaluation and Intervention Programs and Systems.--The
Secretary, acting through the Administrator of the Health
Resources and Services Administration, shall make awards of
grants or cooperative agreements to develop statewide newborn
and infant hearing screening, evaluation, diagnosis, and
intervention programs and systems, and to assist in the
recruitment, retention, education, and training of qualified
personnel and health care providers, for the following
purposes:
(1) To develop and monitor the efficacy of
statewide programs and systems for hearing screening of
newborns and infants; prompt evaluation and diagnosis
of children referred from screening programs; and
appropriate educational, audiological, and medical
interventions for children identified with hearing
loss. Early intervention includes referral to and
delivery of information and services by schools and
agencies, including community, consumer, and parent-
based agencies and organizations and other programs
mandated by part C of the Individuals with Disabilities
Education Act, which offer programs specifically
designed to meet the unique language and communication
needs of deaf and hard of hearing newborns, infants,
toddlers, and children. Programs and systems under this
paragraph shall establish and foster family-to-family
support mechanisms that are critical in the first
months after a child is identified with hearing loss.
(2) To collect data on statewide newborn and infant
hearing screening, evaluation and intervention programs
and systems that can be used for applied research,
program evaluation and policy development.
(3) Other activities may include developing
efficient models to ensure that newborns and infants
who are identified with a hearing loss through
screening receive follow-up by a qualified health care
provider, and State agencies shall be encouraged to
adopt models that effectively increase the rate of
occurrence of such follow-up.
(b) Technical Assistance, Data Management, and Applied
Research.--
(1) Centers for disease control and prevention.--
The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall make
awards of grants or cooperative agreements to provide
technical assistance to State agencies to complement an
intramural program and to conduct applied research
related to newborn and infant hearing screening,
evaluation and intervention programs and systems. The
program shall develop standardized procedures for data
management and program effectiveness and costs, such
as--
(A) to ensure quality monitoring of newborn
and infant hearing loss screening, evaluation,
diagnosis, and intervention programs and
systems;
(B) to provide technical assistance on data
collection and management;
(C) to study the costs and effectiveness of
newborn and infant hearing screening,
evaluation and intervention programs and
systems conducted by State-based programs in
order to answer issues of importance to State
and national policymakers;
(D) to identify the causes and risk factors
for congenital hearing loss;
(E) to study the effectiveness of newborn
and infant hearing screening, audiologic and
medical evaluations and intervention programs
and systems by assessing the health,
intellectual and social developmental,
cognitive, and language status of these
children at school age; and
(F) to promote the sharing of data
regarding early hearing loss with State-based
birth defects and developmental disabilities
monitoring programs for the purpose of
identifying previously unknown causes of
hearing loss.
(2) National institutes of health.--The Director of
the National Institutes of Health, acting through the
Director of the National Institute on Deafness and
Other Communication Disorders, shall for purposes of
this section, continue a program of research and
development on the efficacy of new screening techniques
and technology, including clinical studies of screening
methods, studies on efficacy of intervention, and
related research.
(c) Coordination and Collaboration.--
(1) In general.--In carrying out programs under
this section, the Administrator of the Health Resources
and Services Administration, the Director of the
Centers for Disease Control and Prevention, and the
Director of the National Institutes of Health shall
collaborate and consult with other Federal agencies;
State and local agencies, including those responsible
for early intervention services pursuant to title XIX
of the Social Security Act (Medicaid Early and Periodic
Screening, Diagnosis and Treatment Program); title XXI
of the Social Security Act (State Children's Health
Insurance Program); title V of the Social Security Act
(Maternal and Child Health Block Grant Program); and
part C of the Individuals with Disabilities Education
Act; consumer groups of and that serve individuals who
are deaf and hard-of-hearing and their families;
appropriate national medical and other health and
education specialty organizations; persons who are deaf
and hard-of-hearing and their families; other qualified
professional personnel who are proficient in deaf or
hard-of-hearing children's language and who possess the
specialized knowledge, skills, and attributes needed to
serve deaf and hard-of-hearing newborns, infants,
toddlers, children, and their families; third-party
payers and managed care organizations; and related
commercial industries.
(2) Policy development.--The Administrator of the
Health Resources and Services Administration, the
Director of the Centers for Disease Control and
Prevention, and the Director of the National Institutes
of Health shall coordinate and collaborate on
recommendations for policy development at the Federal
and State levels and with the private sector, including
consumer, medical and other health and education
professional-based organizations, with respect to
newborn and infant hearing screening, evaluation,
diagnosis, and intervention programs and systems.
(3) State early detection, diagnosis, and
intervention programs and systems; data collection.--
The Administrator of the Health Resources and Services
Administration and the Director of the Centers for
Disease Control and Prevention shall coordinate and
collaborate in assisting States to establish newborn
and infant hearing screening, evaluation, diagnosis,
and intervention programs and systems under subsection
(a) and to develop a data collection system under
subsection (b).
(d) Rule of Construction; Religious Accommodation.--Nothing
in this section shall be construed to preempt or prohibit any
State law, including State laws which do not require the
screening for hearing loss of newborn infants or young children
of parents who object to the screening on the grounds that such
screening conflicts with the parents' religious beliefs.
(e) Definitions.--For purposes of this section:
(1) The term ``audiologic evaluation'' refers to
procedures to assess the status of the auditory system;
to establish the site of the auditory disorder; the
type and degree of hearing loss, and the potential
effects of hearing loss on communication; and to
identify appropriate treatment and referral options.
Referral options should include linkage to State
coordinating agencies under part C of the Individuals
with Disabilities Education Act or other appropriate
agencies, medical evaluation, hearing aid /sensory aid
assessment, audiologic rehabilitation treatment,
national and local consumer, self-help, parent, and
education organizations, and other family-centered
services.
(2) The terms ``audiologic rehabilitation'' and
``audiologic intervention'' refer to procedures,
techniques, and technologies to facilitate the
receptive and expressive communication abilities of a
child with hearing loss.
(3) The term ``early intervention'' refers to
providing appropriate services for the child with
hearing loss, including nonmedical services, and
ensuring that families of the child are provided
comprehensive, consumer- oriented information about the
full range of family support, training, information
services, and language and communication options and
are given the opportunity to consider and obtain the
full range of such appropriate services, educational
and program placements, and other options for their
child from highly qualified providers.
(4) The term ``medical evaluation by a physician''
refers to key components including history,
examination, and medical decision making focused on
symptomatic and related body systems for the purpose of
diagnosing the etiology of hearing loss and related
physical conditions, and for identifying appropriate
treatment and referral options.
(5) The term ``medical intervention'' refers to the
process by which a physician provides medical diagnosis
and direction for medical and /or surgical treatment
options of hearing loss and /or related medical
disorder associated with hearing loss.
(6) The term ``newborn and infant hearing
screening'' refers to objective physiologic procedures
to detect possible hearing loss and to identify
newborns and infants who require further audiologic and
medical evaluations.
(f ) Authorization of Appropriations.--
(1) Statewide newborn and infant hearing screening,
evaluation and intervention programs and systems.--For
the purpose of carrying out subsection (a), there are
authorized to be appropriated to the Health Resources
and Services Administration such sums as may be
necessary for fiscal years 2011 through 2015.
(2) Technical assistance, data management, and
applied research; centers for disease control and
prevention.--For the purpose of carrying out subsection
(b)(1), there are authorized to be appropriated to the
Centers for Disease Control and Prevention such sums as
may be necessary for fiscal years 2011 through 2015.
(3) Technical assistance, data management, and
applied research; national institute on deafness and
other communication disorders.--For the purpose of
carrying out subsection (b)(2), there are authorized to
be appropriated to the National Institute on Deafness
and Other Communication Disorders such sums as may be
necessary for fiscal years 2011 through 2015.
SEC. 399N. [280G-2] CHILDHOOD MALIGNANCIES.
(a) In General.--The Secretary, acting as appropriate
through the Director of the Centers for Disease Control and
Prevention and the Director of the National Institutes of
Health, shall study environmental and other risk factors for
childhood cancers (including skeletal malignancies, leukemias,
malignant tumors of the central nervous system, lymphomas, soft
tissue sarcomas, and other malignant neoplasms) and carry out
projects to improve outcomes among children with childhood
cancers and resultant secondary conditions, including limb
loss, anemia, rehabilitation, and palliative care. Such
projects shall be carried out by the Secretary directly and
through awards of grants or contracts.
(b) Certain Activities.--Activities under subsection (a)
include--
(1) the expansion of current demographic data
collection and population surveillance efforts to
include childhood cancers nationally;
(2) the development of a uniform reporting system
under which treating physicians, hospitals, clinics,
and States report the diagnosis of childhood cancers,
including relevant associated epidemiological data; and
(3) support for the National Limb Loss Information
Center to address, in part, the primary and secondary
needs of persons who experience childhood cancers in
order to prevent or minimize the disabling nature of
these cancers.
(c) Coordination of Activities.--The Secretary shall assure
that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities focused on childhood cancers and limb
loss.
(d) Definition.--For purposes of this section, the term
``childhood cancer'' refers to a spectrum of different
malignancies that vary by histology, site of disease, origin,
race, sex, and age. The Secretary may for purposes of this
section revise the definition of such term to the extent
determined by the Secretary to be appropriate.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
SEC. 399O. [280G-3] CONTROLLED SUBSTANCE MONITORING PROGRAM.
(a) Grants.--
(1) In general.--Each fiscal year, the Secretary
shall award a grant to each State with an application
approved under this section to enable the State--
(A) to establish and implement a State
controlled substance monitoring program; or
(B) to make improvements to an existing
State controlled substance monitoring program.
(2) Determination of amount.--
(A) Minimum amount.--In making payments
under a grant under paragraph (1) for a fiscal
year, the Secretary shall allocate to each
State with an application approved under this
section an amount that equals 1.0 percent of
the amount appropriated to carry out this
section for that fiscal year.
(B) Additional amounts.--In making payments
under a grant under paragraph (1) for a fiscal
year, the Secretary shall allocate to each
State with an application approved under this
section an additional amount which bears the
same ratio to the amount appropriated to carry
out this section for that fiscal year and
remaining after amounts are made available
under subparagraph (A) as the number of
pharmacies of the State bears to the number of
pharmacies of all States with applications
approved under this section (as determined by
the Secretary), except that the Secretary may
adjust the amount allocated to a State under
this subparagraph after taking into
consideration the budget cost estimate for the
State's controlled substance monitoring
program.
(3) Term of grants.--Grants awarded under this
section shall be obligated in the year in which funds
are allotted.
(b) Development of Minimum Requirements.--Prior to awarding
a grant under this section, and not later than 6 months after
the date on which funds are first appropriated to carry out
this section, after seeking consultation with States and other
interested parties, the Secretary shall, after publishing in
the Federal Register proposed minimum requirements and
receiving public comments, establish minimum requirements for
criteria to be used by States for purposes of clauses (ii),
(v), (vi), and (vii) of subsection (c)(1)(A).
(c) Application Approval Process.--
(1) In general.--To be eligible to receive a grant
under this section, a State shall submit an application
to the Secretary at such time, in such manner, and
containing such assurances and information as the
Secretary may reasonably require. Each such application
shall include--
(A) with respect to a State that intends to
use funds under the grant as provided for in
subsection (a)(1)(A)--
(i) a budget cost estimate for the
controlled substance monitoring program
to be implemented under the grant;
(ii) criteria for security for
information handling and for the
database maintained by the State under
subsection (e) generally including
efforts to use appropriate encryption
technology or other appropriate
technology to protect the security of
such information;
(iii) an agreement to adopt health
information interoperability standards,
including health vocabulary and
messaging standards, that are
consistent with any such standards
generated or identified by the
Secretary or his or her designee;
(iv) criteria for meeting the
uniform electronic format requirement
of subsection (h);
(v) criteria for availability of
information and limitation on access to
program personnel;
(vi) criteria for access to the
database, and procedures to ensure that
information in the database is
accurate;
(vii) criteria for the use and
disclosure of information, including a
description of the certification
process to be applied to requests for
information under subsection (f);
(viii) penalties for the
unauthorized use and disclosure of
information maintained in the State
controlled substance monitoring program
in violation of applicable State law or
regulation;
(ix) information on the relevant
State laws, policies, and procedures,
if any, regarding purging of
information from the database; and
(x) assurances of compliance with
all other requirements of this section;
or
(B) with respect to a State that intends to
use funds under the grant as provided for in
subsection (a)(1)(B)--
(i) a budget cost estimate for the
controlled substance monitoring program
to be improved under the grant;
(ii) a plan for ensuring that the
State controlled substance monitoring
program is in compliance with the
criteria and penalty requirements
described in clauses (ii) through
(viii) of subparagraph (A);
(iii) a plan to enable the State
controlled substance monitoring program
to achieve interoperability with at
least one other State controlled
substance monitoring program; and
(iv) assurances of compliance with
all other requirements of this section
or a statement describing why such
compliance is not feasible or is
contrary to the best interests of
public health in such State.
(2) State legislation.--As part of an application
under paragraph (1), the Secretary shall require a
State to demonstrate that the State has enacted
legislation or regulations to permit the implementation
of the State controlled substance monitoring program
and the imposition of appropriate penalties for the
unauthorized use and disclosure of information
maintained in such program.
(3) Interoperability.--If a State that submits an
application under this subsection geographically
borders another State that is operating a controlled
substance monitoring program under subsection (a)(1) on
the date of submission of such application, and such
applicant State has not achieved interoperability for
purposes of information sharing between its monitoring
program and the monitoring program of such border
State, such applicant State shall, as part of the plan
under paragraph (1)(B)(iii), describe the manner in
which the applicant State will achieve interoperability
between the monitoring programs of such States.
(4) Approval.--If a State submits an application in
accordance with this subsection, the Secretary shall
approve such application.
(5) Return of funds.--If the Secretary withdraws
approval of a State's application under this section,
or the State chooses to cease to implement or improve a
controlled substance monitoring program under this
section, a funding agreement for the receipt of a grant
under this section is that the State will return to the
Secretary an amount which bears the same ratio to the
overall grant as the remaining time period for
expending the grant funds bears to the overall time
period for expending the grant (as specified by the
Secretary at the time of the grant).
(d) Reporting Requirements.--In implementing or improving a
controlled substance monitoring program under this section, a
State shall comply, or with respect to a State that applies for
a grant under subsection (a)(1)(B) submit to the Secretary for
approval a statement of why such compliance is not feasible or
is contrary to the best interests of public health in such
State, with the following:
(1) The State shall require dispensers to report to
such State each dispensing in the State of a controlled
substance to an ultimate user not later than 1 week
after the date of such dispensing.
(2) The State may exclude from the reporting
requirement of this subsection--
(A) the direct administration of a
controlled substance to the body of an ultimate
user;
(B) the dispensing of a controlled
substance in a quantity limited to an amount
adequate to treat the ultimate user involved
for 48 hours or less; or
(C) the administration or dispensing of a
controlled substance in accordance with any
other exclusion identified by the Secretary for
purposes of this paragraph.
(3) The information to be reported under this
subsection with respect to the dispensing of a
controlled substance shall include the following:
(A) Drug Enforcement Administration
Registration Number (or other identifying
number used in lieu of such Registration
Number) of the dispenser.
(B) Drug Enforcement Administration
Registration Number (or other identifying
number used in lieu of such Registration
Number) and name of the practitioner who
prescribed the drug.
(C) Name, address, and telephone number of
the ultimate user or such contact information
of the ultimate user as the Secretary
determines appropriate.
(D) Identification of the drug by a
national drug code number.
(E) Quantity dispensed.
(F) Number of refills ordered.
(G) Whether the drug was dispensed as a
refill of a prescription or as a first-time
request.
(H) Date of the dispensing.
(I) Date of origin of the prescription.
(J) Such other information as may be
required by State law to be reported under this
subsection.
(4) The State shall require dispensers to report
information under this section in accordance with the
electronic format specified by the Secretary under
subsection (h), except that the State may waive the
requirement of such format with respect to an
individual dispenser that is unable to submit such
information by electronic means.
(e) Database.--In implementing or improving a controlled
substance monitoring program under this section, a State shall
comply with the following:
(1) The State shall establish and maintain an
electronic database containing the information reported
to the State under subsection (d).
(2) The database must be searchable by any field or
combination of fields.
(3) The State shall include reported information in
the database in a manner consistent with criteria
established by the Secretary, with appropriate
safeguards for ensuring the accuracy and completeness
of the database.
(4) The State shall take appropriate security
measures to protect the integrity of, and access to,
the database.
(f) Use and Disclosure of Information.--
(1) In general.--Subject to subsection (g), in
implementing or improving a controlled substance
monitoring program under this section, a State may
disclose information from the database established
under subsection (e) and, in the case of a request
under subparagraph (D), summary statistics of such
information, only in response to a request by--
(A) a practitioner (or the agent thereof)
who certifies, under the procedures determined
by the State, that the requested information is
for the purpose of providing medical or
pharmaceutical treatment or evaluating the need
for such treatment to a bona fide current
patient;
(B) any local, State, or Federal law
enforcement, narcotics control, licensure,
disciplinary, or program authority, who
certifies, under the procedures determined by
the State, that the requested information is
related to an individual investigation or
proceeding involving the unlawful diversion or
misuse of a schedule II, III, or IV substance,
and such information will further the purpose
of the investigation or assist in the
proceeding;
(C) the controlled substance monitoring
program of another State or group of States
with whom the State has established an
interoperability agreement;
(D) any agent of the Department of Health
and Human Services, a State medicaid program, a
State health department, or the Drug
Enforcement Administration who certifies that
the requested information is necessary for
research to be conducted by such department,
program, or administration, respectively, and
the intended purpose of the research is related
to a function committed to such department,
program, or administration by law that is not
investigative in nature; or
(E) an agent of the State agency or entity
of another State that is responsible for the
establishment and maintenance of that State's
controlled substance monitoring program, who
certifies that--
(i) the State has an application
approved under this section; and
(ii) the requested information is
for the purpose of implementing the
State's controlled substance monitoring
program under this section.
(2) Drug diversion.--In consultation with
practitioners, dispensers, and other relevant and
interested stakeholders, a State receiving a grant
under subsection (a)--
(A) shall establish a program to notify
practitioners and dispensers of information
that will help identify and prevent the
unlawful diversion or misuse of controlled
substances; and
(B) may, to the extent permitted under
State law, notify the appropriate authorities
responsible for carrying out drug diversion
investigations if the State determines that
information in the database maintained by the
State under subsection (e) indicates an
unlawful diversion or abuse of a controlled
substance.
(g) Limitations.--In implementing or improving a controlled
substance monitoring program under this section, a State--
(1) shall limit the information provided pursuant
to a valid request under subsection (f)(1) to the
minimum necessary to accomplish the intended purpose of
the request; and
(2) shall limit information provided in response to
a request under subsection (f)(1)(D) to nonidentifiable
information.
(h) Electronic Format.--The Secretary shall specify a
uniform electronic format for the reporting, sharing, and
disclosure of information under this section.
(i) Rules of Construction.--
(1) Functions otherwise authorized by law.--Nothing
in this section shall be construed to restrict the
ability of any authority, including any local, State,
or Federal law enforcement, narcotics control,
licensure, disciplinary, or program authority, to
perform functions otherwise authorized by law.
(2) No preemption.--Nothing in this section shall
be construed as preempting any State law, except that
no such law may relieve any person of a requirement
otherwise applicable under this Act.
(3) Additional privacy protections.--Nothing in
this section shall be construed as preempting any State
from imposing any additional privacy protections.
(4) Federal privacy requirements.--Nothing in this
section shall be construed to supersede any Federal
privacy or confidentiality requirement, including the
regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of
1996 (Public Law 104-191; 110 Stat. 2033) and section
543 of the Public Health Service Act.
(5) No federal private cause of action.--Nothing in
this section shall be construed to create a Federal
private cause of action.
(j) Studies and Reports.--
(1) Implementation report.--
(A) In general.--Not later than 180 days
after the date of enactment of this section,
the Secretary, based on a review of existing
State controlled substance monitoring programs
and other relevant information, shall determine
whether the implementation of such programs has
had a substantial negative impact on--
(i) patient access to treatment,
including therapy for pain or
controlled substance abuse;
(ii) pediatric patient access to
treatment; or
(iii) patient enrollment in
research or clinical trials in which,
following the protocol that has been
approved by the relevant institutional
review board for the research or
clinical trial, the patient has
obtained a controlled substance from
either the scientific investigator
conducting such research or clinical
trial or the agent thereof.
(B) Additional categories of exclusion.--If
the Secretary determines under subparagraph (A)
that a substantial negative impact has been
demonstrated with regard to one or more of the
categories of patients described in such
subparagraph, the Secretary shall identify
additional appropriate categories of exclusion
from reporting as authorized under subsection
(d)(2)(C).
(2) Progress report.--Not later than 3 years after
the date on which funds are first appropriated under
this section, the Secretary shall--
(A) complete a study that--
(i) determines the progress of
States in establishing and implementing
controlled substance monitoring
programs under this section;
(ii) provides an analysis of the
extent to which the operation of
controlled substance monitoring
programs have reduced inappropriate
use, abuse, or diversion of controlled
substances or affected patient access
to appropriate pain care in States
operating such programs;
(iii) determines the progress of
States in achieving interoperability
between controlled substance monitoring
programs, including an assessment of
technical and legal barriers to such
activities and recommendations for
addressing these barriers;
(iv) determines the feasibility of
implementing a real-time electronic
controlled substance monitoring
program, including the costs associated
with establishing such a program;
(v) provides an analysis of the
privacy protections in place for the
information reported to the controlled
substance monitoring program in each
State receiving a grant for the
establishment or operation of such
program, and any recommendations for
additional requirements for protection
of this information;
(vi) determines the feasibility of
implementing technological alternatives
to centralized data storage, such as
peer-to-peer file sharing or data
pointer systems, in controlled
substance monitoring programs and the
potential for such alternatives to
enhance the privacy and security of
individually identifiable data; and
(vii) evaluates the penalties that
States have enacted for the
unauthorized use and disclosure of
information maintained in the
controlled substance monitoring
program, and reports on the criteria
used by the Secretary to determine
whether such penalties qualify as
appropriate pursuant to this section;
and
(B) submit a report to the Congress on the
results of the study.
(k) Preference.--Beginning 3 years after the date on which
funds are first appropriated to carry out this section, the
Secretary, in awarding any competitive grant that is related to
drug abuse (as determined by the Secretary) and for which only
States are eligible to apply, shall give preference to any
State with an application approved under this section. The
Secretary shall have the discretion to apply such preference to
States with existing controlled substance monitoring programs
that meet minimum requirements under this section or to States
that put forth a good faith effort to meet those requirements
(as determined by the Secretary).
(l) Advisory Council.--
(1) Establishment.--A State may establish an
advisory council to assist in the establishment,
implementation, or improvement of a controlled
substance monitoring program under this section.
(2) Limitation.--A State may not use amounts
received under a grant under this section for the
operations of an advisory council established under
paragraph (1).
(3) Sense of congress.--It is the sense of the
Congress that, in establishing an advisory council
under this subsection, a State should consult with
appropriate professional boards and other interested
parties.
(m) Definitions.--For purposes of this section:
(1) The term ``bona fide patient'' means an
individual who is a patient of the practitioner
involved.
(2) The term ``controlled substance'' means a drug
that is included in schedule II, III, or IV of section
202(c) of the Controlled Substance Act.
(3) The term ``dispense'' means to deliver a
controlled substance to an ultimate user by, or
pursuant to the lawful order of, a practitioner,
irrespective of whether the dispenser uses the Internet
or other means to effect such delivery.
(4) The term ``dispenser'' means a physician,
pharmacist, or other person that dispenses a controlled
substance to an ultimate user.
(5) The term ``interoperability'' with respect to a
State controlled substance monitoring program means the
ability of the program to electronically share reported
information, including each of the required report
components described in subsection (d), with another
State if the information concerns either the dispensing
of a controlled substance to an ultimate user who
resides in such other State, or the dispensing of a
controlled substance prescribed by a practitioner whose
principal place of business is located in such other
State.
(6) The term ``nonidentifiable information'' means
information that does not identify a practitioner,
dispenser, or an ultimate user and with respect to
which there is no reasonable basis to believe that the
information can be used to identify a practitioner,
dispenser, or an ultimate user.
(7) The term ``practitioner'' means a physician,
dentist, veterinarian, scientific investigator,
pharmacy, hospital, or other person licensed,
registered, or otherwise permitted, by the United
States or the jurisdiction in which he or she practices
or does research, to distribute, dispense, conduct
research with respect to, administer, or use in
teaching or chemical analysis, a controlled substance
in the course of professional practice or research.
(8) The term ``State'' means each of the 50 States
and the District of Columbia.
(9) The term ``ultimate user'' means a person who
has obtained from a dispenser, and who possesses, a
controlled substance for his or her own use, for the
use of a member of his or her household, or for the use
of an animal owned by him or her or by a member of his
or her household.
(n) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated--
(1) $15,000,000 for each of fiscal years 2006 and
2007; and
(2) $10,000,000 for each of fiscal years 2008,
2009, and 2010.
SEC. 399P. [280G-4] GRANTS TO FOSTER PUBLIC HEALTH RESPONSES TO
DOMESTIC VIOLENCE, DATING VIOLENCE, SEXUAL ASSAULT,
AND STALKING.
(a) Authority to Award Grants.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall award grants to eligible State,
tribal, territorial, or local entities to strengthen
the response of State, tribal, territorial, or local
health care systems to domestic violence, dating
violence, sexual assault, and stalking.
(2) Eligible entities.--To be eligible to receive a
grant under this section, an entity shall--
(A) be--
(i) a State department (or other
division) of health, a State domestic
or sexual assault coalition or service-
based program, State law enforcement
task force, or any other nonprofit,
nongovernmental, tribal, territorial,
or State entity with a history of
effective work in the fields of
domestic violence, dating violence,
sexual assault or stalking, and health
care; or
(ii) a local, nonprofit domestic
violence, dating violence, sexual
assault, or stalking service-based
program, a local department (or other
division) of health, a local health
clinic, hospital, or health system, or
any other nonprofit, tribal, or local
entity with a history of effective work
in the field of domestic or sexual
violence and health;
(B) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such agreements, assurances, and
information as the Secretary determines to be
necessary to carry out the purposes for which
the grant is to be made; and
(C) demonstrate that the entity is
representing a team of organizations and
agencies working collaboratively to strengthen
the response of the health care system involved
to domestic violence, dating violence, sexual
assault, or stalking and that such team
includes domestic violence, dating violence,
sexual assault or stalking and health care
organizations.
(3) Duration.--A program conducted under a grant
awarded under this section shall not exceed 2 years.
(b) Use of Funds.--
(1) In general.--An entity shall use amounts
received under a grant under this section to design and
implement comprehensive strategies to improve the
response of the health care system involved to domestic
or sexual violence in clinical and public health
settings, hospitals, clinics, managed care settings
(including behavioral and mental health), and other
health settings.
(2) Mandatory strategies.--Strategies implemented
under paragraph (1) shall include the following:
(A) The implementation, dissemination, and
evaluation of policies and procedures to guide
health care professionals and behavioral and
public health staff in responding to domestic
violence, dating violence, sexual assault, and
stalking, including strategies to ensure that
health information is maintained in a manner
that protects the patient's privacy and safety
and prohibits insurance discrimination.
(B) The development of on-site access to
services to address the safety, medical, mental
health, and economic needs of patients either
by increasing the capacity of existing health
care professionals and behavioral and public
health staff to address domestic violence,
dating violence, sexual assault, and stalking,
by contracting with or hiring domestic or
sexual assault advocates to provide the
services, or to model other services
appropriate to the geographic and cultural
needs of a site.
(C) The evaluation of practice and the
institutionalization of identification,
intervention, and documentation including
quality improvement measurements.
(D) The provision of training and followup
technical assistance to health care
professionals, behavioral and public health
staff, and allied health professionals to
identify, assess, treat, and refer clients who
are victims of domestic violence, dating
violence, sexual violence, or stalking.
(3) Permissive strategies.--Strategies implemented
under paragraph (1) may include the following:
(A) Where appropriate, the development of
training modules and policies that address the
overlap of child abuse, domestic violence,
dating violence, sexual assault, and stalking
and elder abuse as well as childhood exposure
to domestic violence.
(B) The creation, adaptation, and
implementation of public education campaigns
for patients concerning domestic violence,
dating violence, sexual assault, and stalking
prevention.
(C) The development, adaptation, and
dissemination of domestic violence, dating
violence, sexual assault, and stalking
education materials to patients and health care
professionals and behavioral and public health
staff.
(D) The promotion of the inclusion of
domestic violence, dating violence, sexual
assault, and stalking into health professional
training schools, including medical, dental,
nursing school, social work, and mental health
curriculum.
(E) The integration of domestic violence,
dating violence, sexual assault, and stalking
into health care accreditation and professional
licensing examinations, such as medical,
dental, social work, and nursing boards.
(c) Allocation of Funds.--Funds appropriated under this
section shall be distributed equally between State and local
programs.
(d) Authorization of Appropriations.--There is authorized
to be appropriated to award grants under this section,
$5,000,000 for each of fiscal years 2007 through 2011.
SEC. 399Q. [280G-4] PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND
SUPPORT SERVICES.
(a) In General.--The Secretary, directly or through the
awarding of grants to public or private nonprofit entities, may
conduct demonstration projects for the purpose of improving the
provision of information on prematurity to health professionals
and other health care providers and the public and improving
the treatment and outcomes for babies born preterm.
(b) Activities.--Activities to be carried out under the
demonstration project under subsection (a) may include the
establishment of--
(1) programs to test and evaluate various
strategies to provide information and education to
health professionals, other health care providers, and
the public concerning--
(A) the signs of preterm labor, updated as
new research results become available;
(B) the screening for and the treating of
infections;
(c) counseling on optimal weight and good
nutrition, including folic acid;
(D) smoking cessation education and
counseling;
(E) stress management; and
(F) appropriate prenatal care;
(2) programs to improve the treatment and outcomes
for babies born premature, including the use of
evidence-based standards of care by health care
professionals for pregnant women at risk of preterm
labor or other serious complications and for infants
born preterm and at a low birthweight;
(3) programs to respond to the informational needs
of families during the stay of an infant in a neonatal
intensive care unit, during the transition of the
infant to the home, and in the event of a newborn
death; and
(4) such other programs as the Secretary determines
appropriate to achieve the purpose specified in
subsection (a).
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2007 through 2011.
SEC. 399R. [280G-6] CHRONIC KIDNEY DISEASE INITIATIVES.
(a) In General.--The Secretary shall establish pilot
projects to--
(1) increase public and medical community awareness
(particularly of those who treat patients with diabetes
and hypertension) regarding chronic kidney disease,
focusing on prevention;
(2) increase screening for chronic kidney disease,
focusing on Medicare beneficiaries at risk of chronic
kidney disease; and
(3) enhance surveillance systems to better assess
the prevalence and incidence of chronic kidney disease.
(b) Scope and Duration.--
(1) Scope.--The Secretary shall select at least 3
States in which to conduct pilot projects under this
section.
(2) Duration.--The pilot projects under this
section shall be conducted for a period that is not
longer than 5 years and shall begin on January 1, 2009.
(c) Evaluation and Report.--The Comptroller General of the
United States shall conduct an evaluation of the pilot projects
conducted under this section. Not later than 12 months after
the date on which the pilot projects are completed, the
Comptroller General shall submit to Congress a report on the
evaluation.
(d) Authorization of Appropriations.--There are authorized
to be appropriated such sums as may be necessary for the
purpose of carrying out this section.
SEC. 399S.[280G-7] AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
(a) Establishment.--
(1) In general.--Not later than 1 year after the
receipt of the report described in subsection
(b)(2)(A), the Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may,
if scientifically advisable--
(A) develop a system to collect data on
amyotrophic lateral sclerosis (referred to in
this section as ``ALS'') and other motor neuron
disorders that can be confused with ALS,
misdiagnosed as ALS, and in some cases progress
to ALS, including information with respect to
the incidence and prevalence of the disease in
the United States; and
(B) establish a national registry for the
collection and storage of such data to develop
a population-based registry of cases in the
United States of ALS and other motor neuron
disorders that can be confused with ALS,
misdiagnosed as ALS, and in some cases progress
to ALS.
(2) Purpose.--It is the purpose of the registry
established under paragraph (1)(B) to--
(A) better describe the incidence and
prevalence of ALS in the United States;
(B) examine appropriate factors, such as
environmental and occupational, that may be
associated with the disease;
(C) better outline key demographic factors
(such as age, race or ethnicity, gender, and
family history of individuals who are diagnosed
with the disease) associated with the disease;
(D) better examine the connection between
ALS and other motor neuron disorders that can
be confused with ALS, misdiagnosed as ALS, and
in some cases progress to ALS; and
(E) other matters as recommended by the
Advisory Committee established under subsection
(b).
(b) Advisory Committee.--
(1) Establishment.--Not later than 180 days after
the date of the enactment of this section, the
Secretary, acting through the Director of the Centers
for Disease Control and Prevention, may establish a
committee to be known as the Advisory Committee on the
National ALS Registry (referred to in this section as
the ``Advisory Committee''). The Advisory Committee
shall be composed of not more than 27 members to be
appointed by the Secretary, acting through the Centers
for Disease Control and Prevention, of which--
(A) two-thirds of such members shall
represent governmental agencies--
(i) including at least one member
representing--
(I) the National Institutes
of Health, to include, upon the
recommendation of the Director
of the National Institutes of
Health, representatives from
the National Institute of
Neurological Disorders and
Stroke and the National
Institute of Environmental
Health Sciences;
(II) the Department of
Veterans Affairs;
(III) the Agency for Toxic
Substances and Disease
Registry; and
(IV) the Centers for
Disease Control and Prevention;
and
(ii) of which at least one such
member shall be a clinician with
expertise on ALS and related diseases,
an epidemiologist with experience in
data registries, a statistician, an
ethicist, and a privacy expert
(relating to the privacy regulations
under the Health Insurance Portability
and Accountability Act of 1996); and
(B) one-third of such members shall be
public members, including at least one member
representing--
(i) national and voluntary health
associations;
(ii) patients with ALS or their
family members;
(iii) clinicians with expertise on
ALS and related diseases;
(iv) epidemiologists with
experience in data registries;
(v) geneticists or experts in
genetics who have experience with the
genetics of ALS or other neurological
diseases and
(vi) other individuals with an
interest in developing and maintaining
the National ALS Registry.
(2) Duties.--The Advisory Committee may review
information and make recommendations to the Secretary
concerning--
(A) the development and maintenance of the
National ALS Registry;
(B) the type of information to be collected
and stored in the Registry;
(C) the manner in which such data is to be
collected;
(D) the use and availability of such data
including guidelines for such use; and
(E) the collection of information about
diseases and disorders that primarily affect
motor neurons that are considered essential to
furthering the study and cure of ALS.
(3) Report.--Not later than 270 days after the date
on which the Advisory Committee is established, the
Advisory Committee may submit a report to the Secretary
concerning the review conducted under paragraph (2)
that contains the recommendations of the Advisory
Committee with respect to the results of such review.
(c) Grants.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may award
grants to, and enter into contracts and cooperative agreements
with, public or private nonprofit entities for the collection,
analysis, and reporting of data on ALS and other motor neuron
disorders that can be confused with ALS, misdiagnosed as ALS,
and in some cases progress to ALS after receiving the report
under subsection (b)(3).
(d) Coordination With State, Local, and Federal
Registries.--
(1) \1\ In general.--In establishing the National
ALS Registry under subsection (a), the Secretary,
acting through the Director of the Centers for Disease
Control and Prevention, may--
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\1\ So in law. Subsection (d) (as added by section 2 of Public Law
110-373) does not include a paragraph (2).
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(A) identify, build upon, expand, and
coordinate among existing data and surveillance
systems, surveys, registries, and other Federal
public health and environmental infrastructure
wherever possible, which may include--
(i) any registry pilot projects
previously supported by the Centers for
Disease Control and Prevention;
(ii) the Department of Veterans
Affairs ALS Registry;
(iii) the DNA and Cell Line
Repository of the National Institute of
Neurological Disorders and Stroke Human
Genetics Resource Center at the
National Institutes of Health;
(iv) Agency for Toxic Substances
and Disease Registry studies, including
studies conducted in Illinois,
Missouri, El Paso and San Antonio,
Texas, and Massachusetts;
(v) State-based ALS registries;
(vi) the National Vital Statistics
System; and
(vii) any other existing or
relevant databases that collect or
maintain information on those motor
neuron diseases recommended by the
Advisory Committee established in
subsection (b); and
(B) provide for research access to ALS data
as recommended by the Advisory Committee
established in subsection (b) to the extent
permitted by applicable statutes and
regulations and in a manner that protects
personal privacy consistent with applicable
privacy statutes and regulations.
(C) Coordination with nih and department of
veterans affairs.--Consistent with applicable
privacy statutes and regulations, the Secretary
may ensure that epidemiological and other types
of information obtained under subsection (a) is
made available to the National Institutes of
Health and the Department of Veterans Affairs.
(e) Definition.--For the purposes of this section, the term
``national voluntary health association'' means a national non-
profit organization with chapters or other affiliated
organizations in States throughout the United States with
experience serving the population of individuals with ALS and
have demonstrated experience in ALS research, care, and patient
services.
SEC. 399T. [280G-8] SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS
OF DOWN SYNDROME OR OTHER PRENATALLY OR POSTNATALLY
DIAGNOSED CONDITIONS.
(a) Definitions.--In this section:
(1) Down syndrome.--The term ``Down syndrome''
refers to a chromosomal disorder caused by an error in
cell division that results in the presence of an extra
whole or partial copy of chromosome 21.
(2) Health care provider.--The term ``health care
provider'' means any person or entity required by State
or Federal law or regulation to be licensed,
registered, or certified to provide health care
services, and who is so licensed, registered, or
certified.
(3) Postnatally diagnosed condition.--The term
``postnatally diagnosed condition'' means any health
condition identified during the 12-month period
beginning at birth.
(4) Prenatally diagnosed condition.--The term
``prenatally diagnosed condition'' means any fetal
health condition identified by prenatal genetic testing
or prenatal screening procedures.
(5) Prenatal test.--The term ``prenatal test''
means diagnostic or screening tests offered to pregnant
women seeking routine prenatal care that are
administered on a required or recommended basis by a
health care provider based on medical history, family
background, ethnic background, previous test results,
or other risk factors.
(b) Information and Support Services.--
(1) In general.--The Secretary, acting through the
Director of the National Institutes of Health, the
Director of the Centers for Disease Control and
Prevention, or the Administrator of the Health
Resources and Services Administration, may authorize
and oversee certain activities, including the awarding
of grants, contracts or cooperative agreements to
eligible entities, to--
(A) collect, synthesize, and disseminate
current evidence-based information relating to
Down syndrome or other prenatally or
postnatally diagnosed conditions; and
(B) coordinate the provision of, and access
to, new or existing supportive services for
patients receiving a positive diagnosis for
Down syndrome or other prenatally or
postnatally diagnosed conditions, including--
(i) the establishment of a resource
telephone hotline accessible to
patients receiving a positive test
result or to the parents of newly
diagnosed infants with Down syndrome
and other diagnosed conditions;
(ii) the expansion and further
development of the National
Dissemination Center for Children with
Disabilities, so that such Center can
more effectively conduct outreach to
new and expecting parents and provide
them with up-to-date information on the
range of outcomes for individuals
living with the diagnosed condition,
including physical, developmental,
educational, and psychosocial outcomes;
(iii) the expansion and further
development of national and local peer-
support programs, so that such programs
can more effectively serve women who
receive a positive diagnosis for Down
syndrome or other prenatal conditions
or parents of infants with a
postnatally diagnosed condition;
(iv) the establishment of a
national registry, or network of local
registries, of families willing to
adopt newborns with Down syndrome or
other prenatally or postnatally
diagnosed conditions, and links to
adoption agencies willing to place
babies with Down syndrome or other
prenatally or postnatally diagnosed
conditions, with families willing to
adopt; and
(v) the establishment of awareness
and education programs for health care
providers who provide, interpret, or
inform parents of the results of
prenatal tests for Down syndrome or
other prenatally or postnatally
diagnosed conditions, to patients,
consistent with the purpose described
in section 2(b)(1) \1\ of the
Prenatally and Postnatally Diagnosed
Conditions Awareness Act.
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\1\ So in law. Probably should read ``section 2(1)''.
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(2) Eligible entity.--In this subsection, the term
``eligible entity'' means--
(A) a State or a political subdivision of a
State;
(B) a consortium of 2 or more States or
political subdivisions of States;
(C) a territory;
(D) a health facility or program operated
by or pursuant to a contract with or grant from
the Indian Health Service; or
(E) any other entity with appropriate
expertise in prenatally and postnatally
diagnosed conditions (including nationally
recognized disability groups), as determined by
the Secretary.
(3) Distribution.--In distributing funds under this
subsection, the Secretary shall place an emphasis on
funding partnerships between health care professional
groups and disability advocacy organizations.
(c) Provision of Information to Providers.--
(1) In general.--A grantee under this section shall
make available to health care providers of parents who
receive a prenatal or postnatal diagnosis the
following:
(A) Up-to-date, evidence-based, written
information concerning the range of outcomes
for individuals living with the diagnosed
condition, including physical, developmental,
educational, and psychosocial outcomes.
(B) Contact information regarding support
services, including information hotlines
specific to Down syndrome or other prenatally
or postnatally diagnosed conditions, resource
centers or clearinghouses, national and local
peer support groups, and other education and
support programs as described in subsection
(b)(2).
(2) Informational requirements.--Information
provided under this subsection shall be--
(A) culturally and linguistically
appropriate as needed by women receiving a
positive prenatal diagnosis or the family of
infants receiving a postnatal diagnosis; and
(B) approved by the Secretary.
(d) Report.--Not later than 2 years after the date of
enactment of this section, the Government Accountability Office
shall submit a report to Congress concerning the effectiveness
of current healthcare and family support programs serving as
resources for the families of children with disabilities.
SEC. 399U. [280G-10] COMMUNITY PREVENTIVE SERVICES TASK FORCE.
(a) Establishment and Purpose.--The Director of the Centers
for Disease Control and Prevention shall convene an independent
Community Preventive Services Task Force (referred to in this
subsection as the ``Task Force'') to be composed of individuals
with appropriate expertise. Such Task Force shall review the
scientific evidence related to the effectiveness,
appropriateness, and cost-effectiveness of community preventive
interventions for the purpose of developing recommendations, to
be published in the Guide to Community Preventive Services
(referred to in this section as the ``Guide''), for individuals
and organizations delivering population-based services,
including primary care professionals, health care systems,
professional societies, employers, community organizations,
non-profit organizations, schools, governmental public health
agencies, Indian tribes, tribal organizations and urban Indian
organizations, medical groups, Congress and other policy-
makers. Community preventive services include any policies,
programs, processes or activities designed to affect or
otherwise affecting health at the population level.
(b) Duties.--The duties of the Task Force shall include--
(1) the development of additional topic areas for
new recommendations and interventions related to those
topic areas, including those related to specific
populations and age groups, as well as the social,
economic and physical environments that can have broad
effects on the health and disease of populations and
health disparities among sub-populations and age
groups;
(2) at least once during every 5-year period,
review interventions and update recommendations related
to existing topic areas, including new or improved
techniques to assess the health effects of
interventions, including health impact assessment and
population health modeling;
(3) improved integration with Federal Government
health objectives and related target setting for health
improvement;
(4) the enhanced dissemination of recommendations;
(5) the provision of technical assistance to those
health care professionals, agencies, and organizations
that request help in implementing the Guide
recommendations; and
(6) providing yearly reports to Congress and
related agencies identifying gaps in research and
recommending priority areas that deserve further
examination, including areas related to populations and
age groups not adequately addressed by current
recommendations.
(c) Role of Agency.--The Director shall provide ongoing
administrative, research, and technical support for the
operations of the Task Force, including coordinating and
supporting the dissemination of the recommendations of the Task
Force, ensuring adequate staff resources, and assistance to
those organizations requesting it for implementation of Guide
recommendations.
(d) Coordination With Preventive Services Task Force.--The
Task Force shall take appropriate steps to coordinate its work
with the U.S. Preventive Services Task Force and the Advisory
Committee on Immunization Practices, including the examination
of how each task force's recommendations interact at the nexus
of clinic and community.
(e) Operation.--In carrying out the duties under subsection
(b), the Task Force shall not be subject to the provisions of
Appendix 2 of title 5, United States Code.
(f) Authorization of Appropriations.--There are authorized
to be appropriated such sums as may be necessary for each
fiscal year to carry out the activities of the Task Force.
SEC. 399V. [280G-11]GRANTS TO PROMOTE POSITIVE HEALTH BEHAVIORS AND
OUTCOMES.
(a) Grants Authorized.--The Director of the Centers for
Disease Control and Prevention, in collaboration with the
Secretary, shall award grants to eligible entities to promote
positive health behaviors and outcomes for populations in
medically underserved communities through the use of community
health workers.
(b) Use of Funds.--Grants awarded under subsection (a)
shall be used to support community health workers--
(1) to educate, guide, and provide outreach in a
community setting regarding health problems prevalent
in medically underserved communities, particularly
racial and ethnic minority populations;
(2) to educate and provide guidance regarding
effective strategies to promote positive health
behaviors and discourage risky health behaviors;
(3) to educate and provide outreach regarding
enrollment in health insurance including the Children's
Health Insurance Program under title XXI of the Social
Security Act, Medicare under title XVIII of such Act
and Medicaid under title XIX of such Act;
(4) to identify and refer underserved populations
to appropriate healthcare agencies and community-based
programs and organizations in order to increase access
to quality healthcare services and to eliminate
duplicative care; or
(5) to educate, guide, and provide home visitation
services regarding maternal health and prenatal care.
(c) Application.--Each eligible entity that desires to
receive a grant under subsection (a) shall submit an
application to the Secretary, at such time, in such manner, and
accompanied by such information as the Secretary may require.
(d) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to applicants that--
(1) propose to target geographic areas--
(A) with a high percentage of residents who
are eligible for health insurance but are
uninsured or underinsured;
(B) with a high percentage of residents who
suffer from chronic diseases; or
(C) with a high infant mortality rate;
(2) have experience in providing health or health-
related social services to individuals who are
underserved with respect to such services; and
(3) have documented community activity and
experience with community health workers.
(e) Collaboration With Academic Institutions and the One-
stop Delivery System.--The Secretary shall encourage community
health worker programs receiving funds under this section to
collaborate with academic institutions and one-stop delivery
systems under section 134(c) of the Workforce Investment Act of
1998. Nothing in this section shall be construed to require
such collaboration.
(f) Evidence-based Interventions.--The Secretary shall
encourage community health worker programs receiving funding
under this section to implement a process or an outcome-based
payment system that rewards community health workers for
connecting underserved populations with the most appropriate
services at the most appropriate time. Nothing in this section
shall be construed to require such a payment.
(g) Quality Assurance and Cost Effectiveness.--The
Secretary shall establish guidelines for assuring the quality
of the training and supervision of community health workers
under the programs funded under this section and for assuring
the cost-effectiveness of such programs.
(h) Monitoring.--The Secretary shall monitor community
health worker programs identified in approved applications
under this section and shall determine whether such programs
are in compliance with the guidelines established under
subsection (g).
(i) Technical Assistance.--The Secretary may provide
technical assistance to community health worker programs
identified in approved applications under this section with
respect to planning, developing, and operating programs under
the grant.
(j) Authorization of Appropriations.--There are authorized
to be appropriated, such sums as may be necessary to carry out
this section for each of fiscal years 2010 through 2014.
(k) Definitions.--In this section:
(1) Community health worker.--The term ``community
health worker'' means an individual who promotes health
or nutrition within the community in which the
individual resides--
(A) by serving as a liaison between
communities and healthcare agencies;
(B) by providing guidance and social
assistance to community residents;
(C) by enhancing community residents'
ability to effectively communicate with
healthcare providers;
(D) by providing culturally and
linguistically appropriate health or nutrition
education;
(E) by advocating for individual and
community health;
(F) by providing referral and follow-up
services or otherwise coordinating care; and
(G) by proactively identifying and
enrolling eligible individuals in Federal,
State, local, private or nonprofit health and
human services programs.
(2) Community setting.--The term ``community
setting'' means a home or a community organization
located in the neighborhood in which a participant in
the program under this section resides.
(3) Eligible entity.--The term ``eligible entity''
means a public or nonprofit private entity (including a
State or public subdivision of a State, a public health
department, a free health clinic, a hospital, or a
Federally-qualified health center (as defined in
section 1861(aa) of the Social Security Act)), or a
consortium of any such entities.
(4) Medically underserved community.--The term
``medically underserved community'' means a community
identified by a State--
(A) that has a substantial number of
individuals who are members of a medically
underserved population, as defined by section
330(b)(3); and
(B) a significant portion of which is a
health professional shortage area as designated
under section 332.
SEC. 399V-1. [280G-12] PRIMARY CARE EXTENSION PROGRAM.
(a) Establishment, Purpose and Definition.--
(1) In general.--The Secretary, acting through the
Director of the Agency for Healthcare Research and
Quality, shall establish a Primary Care Extension
Program.
(2) Purpose.--The Primary Care Extension Program
shall provide support and assistance to primary care
providers to educate providers about preventive
medicine, health promotion, chronic disease management,
mental and behavioral health services (including
substance abuse prevention and treatment services), and
evidence-based and evidence-informed therapies and
techniques, in order to enable providers to incorporate
such matters into their practice and to improve
community health by working with community-based health
connectors (referred to in this section as ``Health
Extension Agents'').
(3) Definitions.--In this section:
(A) Health extension agent.--The term
``Health Extension Agent'' means any local,
community-based health worker who facilitates
and provides assistance to primary care
practices by implementing quality improvement
or system redesign, incorporating the
principles of the patient-centered medical home
to provide high-quality, effective, efficient,
and safe primary care and to provide guidance
to patients in culturally and linguistically
appropriate ways, and linking practices to
diverse health system resources.
(B) Primary care provider.--The term
``primary care provider'' means a clinician who
provides integrated, accessible health care
services and who is accountable for addressing
a large majority of personal health care needs,
including providing preventive and health
promotion services for men, women, and children
of all ages, developing a sustained partnership
with patients, and practicing in the context of
family and community, as recognized by a State
licensing or regulatory authority, unless
otherwise specified in this section.
(b) Grants To Establish State Hubs and Local Primary Care
Extension Agencies.--
(1) Grants.--The Secretary shall award competitive
grants to States for the establishment of State- or
multistate-level primary care Primary Care Extension
Program State Hubs (referred to in this section as
``Hubs'').
(2) Composition of hubs.--A Hub established by a
State pursuant to paragraph (1)--
(A) shall consist of, at a minimum, the
State health department, the entity responsible
for administering the State Medicaid program
(if other than the State health department),
the State-level entity administering the
Medicare program, and the departments that
train providers in primary care in 1 or more
health professions schools in the State; and
(B) may include entities such as hospital
associations, primary care practice-based
research networks, health professional
societies, State primary care associations,
State licensing boards, organizations with a
contract with the Secretary under section 1153
of the Social Security Act, consumer groups,
and other appropriate entities.
(c) State and Local Activities.--
(1) Hub activities.--Hubs established under a grant
under subsection (b) shall--
(A) submit to the Secretary a plan to
coordinate functions with quality improvement
organizations and area health education centers
if such entities are members of the Hub not
described in subsection (b)(2)(A);
(B) contract with a county- or local-level
entity that shall serve as the Primary Care
Extension Agency to administer the services
described in paragraph (2);
(C) organize and administer grant funds to
county- or local-level Primary Care Extension
Agencies that serve a catchment area, as
determined by the State; and
(D) organize State-wide or multistate
networks of local-level Primary Care Extension
Agencies to share and disseminate information
and practices.
(2) Local primary care extension agency
activities.--
(A) Required activities.--Primary Care
Extension Agencies established by a Hub under
paragraph (1) shall--
(i) assist primary care providers
to implement a patient-centered medical
home to improve the accessibility,
quality, and efficiency of primary care
services, including health homes;
(ii) develop and support primary
care learning communities to enhance
the dissemination of research findings
for evidence-based practice, assess
implementation of practice improvement,
share best practices, and involve
community clinicians in the generation
of new knowledge and identification of
important questions for research;
(iii) participate in a national
network of Primary Care Extension Hubs
and propose how the Primary Care
Extension Agency will share and
disseminate lessons learned and best
practices; and
(iv) develop a plan for financial
sustainability involving State, local,
and private contributions, to provide
for the reduction in Federal funds that
is expected after an initial 6-year
period of program establishment,
infrastructure development, and
planning.
(B) Discretionary activities.--Primary Care
Extension Agencies established by a Hub under
paragraph (1) may--
(i) provide technical assistance,
training, and organizational support
for community health teams established
under section 3602 of the Patient
Protection and Affordable Care Act;
(ii) collect data and provision of
primary care provider feedback from
standardized measurements of processes
and outcomes to aid in continuous
performance improvement;
(iii) collaborate with local health
departments, community health centers,
tribes and tribal entities, and other
community agencies to identify
community health priorities and local
health workforce needs, and participate
in community-based efforts to address
the social and primary determinants of
health, strengthen the local primary
care workforce, and eliminate health
disparities;
(iv) develop measures to monitor
the impact of the proposed program on
the health of practice enrollees and of
the wider community served; and
(v) participate in other
activities, as determined appropriate
by the Secretary.
(d) Federal Program Administration.--
(1) Grants; types.--Grants awarded under subsection
(b) shall be--
(A) program grants, that are awarded to
State or multistate entities that submit fully-
developed plans for the implementation of a
Hub, for a period of 6 years; or
(B) planning grants, that are awarded to
State or multistate entities with the goal of
developing a plan for a Hub, for a period of 2
years.
(2) Applications.--To be eligible for a grant under
subsection (b), a State or multistate entity shall
submit to the Secretary an application, at such time,
in such manner, and containing such information as the
Secretary may require.
(3) Evaluation.--A State that receives a grant
under subsection (b) shall be evaluated at the end of
the grant period by an evaluation panel appointed by
the Secretary.
(4) Continuing support.--After the sixth year in
which assistance is provided to a State under a grant
awarded under subsection (b), the State may receive
additional support under this section if the State
program has received satisfactory evaluations with
respect to program performance and the merits of the
State sustainability plan, as determined by the
Secretary.
(5) Limitation.--A State shall not use in excess of
10 percent of the amount received under a grant to
carry out administrative activities under this section.
Funds awarded pursuant to this section shall not be
used for funding direct patient care.
(e) Requirements on the Secretary.--In carrying out this
section, the Secretary shall consult with the heads of other
Federal agencies with demonstrated experience and expertise in
health care and preventive medicine, such as the Centers for
Disease Control and Prevention, the Substance Abuse and Mental
Health Administration, the Health Resources and Services
Administration, the National Institutes of Health, the Office
of the National Coordinator for Health Information Technology,
the Indian Health Service, the Agricultural Cooperative
Extension Service of the Department of Agriculture, and other
entities, as the Secretary determines appropriate.
(f) Authorization of Appropriations.--To awards grants as
provided in subsection (d), there are authorized to be
appropriated $120,000,000 for each of fiscal years 2011 and
2012, and such sums as may be necessary to carry out this
section for each of fiscal years 2013 through 2014.
SEC. 399V-2. [280G-13] NATIONAL CONGENITAL HEART DISEASE SURVEILLANCE
SYSTEM.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may--
(1) enhance and expand infrastructure to track the
epidemiology of congenital heart disease and to
organize such information into a nationally-
representative, population-based surveillance system
that compiles data concerning actual occurrences of
congenital heart disease, to be known as the `National
Congenital Heart Disease Surveillance System'; or
(2) award a grant to one eligible entity to
undertake the activities described in paragraph (1).
(b) Purpose.--The purpose of the Congenital Heart Disease
Surveillance System shall be to facilitate further research
into the types of health services patients use and to identify
possible areas for educational outreach and prevention in
accordance with standard practices of the Centers for Disease
Control and Prevention.
(c) Content.--The Congenital Heart Disease Surveillance
System--
(1) may include information concerning the
incidence and prevalence of congenital heart disease in
the United States;
(2) may be used to collect and store data on
congenital heart disease, including data concerning--
(A) demographic factors associated with
congenital heart disease, such as age, race,
ethnicity, sex, and family history of
individuals who are diagnosed with the disease;
(B) risk factors associated with the
disease;
(C) causation of the disease;
(D) treatment approaches; and
(E) outcome measures, such that analysis of
the outcome measures will allow derivation of
evidence-based best practices and guidelines
for congenital heart disease patients; and
(3) may ensure the collection and analysis of
longitudinal data related to individuals of all ages
with congenital heart disease, including infants, young
children, adolescents, and adults of all ages.
(d) Public Access.--The Congenital Heart Disease
Surveillance System shall be made available to the public, as
appropriate, including congenital heart disease researchers.
(e) Patient Privacy.--The Secretary shall ensure that the
Congenital Heart Disease Surveillance System is maintained in a
manner that complies with the regulations promulgated under
section 264 of the Health Insurance Portability and
Accountability Act of 1996.
(f) Eligibility for Grant.--To be eligible to receive a
grant under subsection (a)(2), an entity shall--
(1) be a public or private nonprofit entity with
specialized experience in congenital heart disease; and
(2) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require.
SEC. 399V-3. [280G-14] NATIONAL DIABETES PREVENTION PROGRAM.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall
establish a national diabetes prevention program (referred to
in this section as the ``program'') targeted at adults at high
risk for diabetes in order to eliminate the preventable burden
of diabetes.
(b) Program Activities.--The program described in
subsection (a) shall include--
(1) a grant program for community-based diabetes
prevention program model sites;
(2) a program within the Centers for Disease
Control and Prevention to determine eligibility of
entities to deliver community-based diabetes prevention
services;
(3) a training and outreach program for lifestyle
intervention instructors; and
(4) evaluation, monitoring and technical
assistance, and applied research carried out by the
Centers for Disease Control and Prevention.
(c) Eligible Entities.--To be eligible for a grant under
subsection (b)(1), an entity shall be a State or local health
department, a tribal organization, a national network of
community-based non-profits focused on health and wellbeing, an
academic institution, or other entity, as the Secretary
determines.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2010 through 2014.
SEC. 399V-4. [280G-15] STATE DEMONSTRATION PROGRAMS TO EVALUATE
ALTERNATIVES TO CURRENT MEDICAL TORT LITIGATION.
(a) In General.--The Secretary is authorized to award
demonstration grants to States for the development,
implementation, and evaluation of alternatives to current tort
litigation for resolving disputes over injuries allegedly
caused by health care providers or health care organizations.
In awarding such grants, the Secretary shall ensure the
diversity of the alternatives so funded.
(b) Duration.--The Secretary may award grants under
subsection (a) for a period not to exceed 5 years.
(c) Conditions for Demonstration Grants.--
(1) Requirements.--Each State desiring a grant
under subsection (a) shall develop an alternative to
current tort litigation that--
(A) allows for the resolution of disputes
over injuries allegedly caused by health care
providers or health care organizations; and
(B) promotes a reduction of health care
errors by encouraging the collection and
analysis of patient safety data related to
disputes resolved under subparagraph (A) by
organizations that engage in efforts to improve
patient safety and the quality of health care.
(2) Alternative to current tort litigation.--Each
State desiring a grant under subsection (a) shall
demonstrate how the proposed alternative described in
paragraph (1)(A)--
(A) makes the medical liability system more
reliable by increasing the availability of
prompt and fair resolution of disputes;
(B) encourages the efficient resolution of
disputes;
(C) encourages the disclosure of health
care errors;
(D) enhances patient safety by detecting,
analyzing, and helping to reduce medical errors
and adverse events;
(E) improves access to liability insurance;
(F) fully informs patients about the
differences in the alternative and current tort
litigation;
(G) provides patients the ability to opt
out of or voluntarily withdraw from
participating in the alternative at any time
and to pursue other options, including
litigation, outside the alternative;
(H) would not conflict with State law at
the time of the application in a way that would
prohibit the adoption of an alternative to
current tort litigation; and
(I) would not limit or curtail a patient's
existing legal rights, ability to file a claim
in or access a State's legal system, or
otherwise abrogate a patient's ability to file
a medical malpractice claim.
(3) Sources of compensation.--Each State desiring a
grant under subsection (a) shall identify the sources
from and methods by which compensation would be paid
for claims resolved under the proposed alternative to
current tort litigation, which may include public or
private funding sources, or a combination of such
sources. Funding methods shall to the extent
practicable provide financial incentives for activities
that improve patient safety.
(4) Scope.--
(A) In general.--Each State desiring a
grant under subsection (a) shall establish a
scope of jurisdiction (such as Statewide,
designated geographic region, a designated area
of health care practice, or a designated group
of health care providers or health care
organizations) for the proposed alternative to
current tort litigation that is sufficient to
evaluate the effects of the alternative. No
scope of jurisdiction shall be established
under this paragraph that is based on a health
care payer or patient population.
(B) Notification of patients.--A State
shall demonstrate how patients would be
notified that they are receiving health care
services that fall within such scope, and the
process by which they may opt out of or
voluntarily withdraw from participating in the
alternative. The decision of the patient
whether to participate or continue
participating in the alternative process shall
be made at any time and shall not be limited in
any way.
(5) Preference in awarding demonstration grants.--
In awarding grants under subsection (a), the Secretary
shall give preference to States--
(A) that have developed the proposed
alternative through substantive consultation
with relevant stakeholders, including patient
advocates, health care providers and health
care organizations, attorneys with expertise in
representing patients and health care
providers, medical malpractice insurers, and
patient safety experts;
(B) that make proposals that are likely to
enhance patient safety by detecting, analyzing,
and helping to reduce medical errors and
adverse events; and
(C) that make proposals that are likely to
improve access to liability insurance.
(d) Application.--
(1) In general.--Each State desiring a grant under
subsection (a) shall submit to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary may
require.
(2) Review panel.--
(A) In general.--In reviewing applications
under paragraph (1), the Secretary shall
consult with a review panel composed of
relevant experts appointed by the Comptroller
General.
(B) Composition.--
(i) Nominations.--The Comptroller
General shall solicit nominations from
the public for individuals to serve on
the review panel.
(ii) Appointment.--The Comptroller
General shall appoint, at least 9 but
not more than 13, highly qualified and
knowledgeable individuals to serve on
the review panel and shall ensure that
the following entities receive fair
representation on such panel:
(I) Patient advocates.
(II) Health care providers
and health care organizations.
(III) Attorneys with
expertise in representing
patients and health care
providers.
(IV) Medical malpractice
insurers.
(V) State officials.
(VI) Patient safety
experts.
(C) Chairperson.--The Comptroller General,
or an individual within the Government
Accountability Office designated by the
Comptroller General, shall be the chairperson
of the review panel.
(D) Availability of information.--The
Comptroller General shall make available to the
review panel such information, personnel, and
administrative services and assistance as the
review panel may reasonably require to carry
out its duties.
(E) Information from agencies.--The review
panel may request directly from any department
or agency of the United States any information
that such panel considers necessary to carry
out its duties. To the extent consistent with
applicable laws and regulations, the head of
such department or agency shall furnish the
requested information to the review panel.
(e) Reports.--
(1) By state.--Each State receiving a grant under
subsection (a) shall submit to the Secretary an annual
report evaluating the effectiveness of activities
funded with grants awarded under such subsection. Such
report shall, at a minimum, include the impact of the
activities funded on patient safety and on the
availability and price of medical liability insurance.
(2) By secretary.--The Secretary shall submit to
Congress an annual compendium of the reports submitted
under paragraph (1) and an analysis of the activities
funded under subsection (a) that examines any
differences that result from such activities in terms
of the quality of care, number and nature of medical
errors, medical resources used, length of time for
dispute resolution, and the availability and price of
liability insurance.
(f) Technical Assistance.--
(1) In general.--The Secretary shall provide
technical assistance to the States applying for or
awarded grants under subsection (a).
(2) Requirements.--Technical assistance under
paragraph (1) shall include--
(A) guidance on non-economic damages,
including the consideration of individual facts
and circumstances in determining appropriate
payment, guidance on identifying avoidable
injuries, and guidance on disclosure to
patients of health care errors and adverse
events; and
(B) the development, in consultation with
States, of common definitions, formats, and
data collection infrastructure for States
receiving grants under this section to use in
reporting to facilitate aggregation and
analysis of data both within and between
States.
(3) Use of common definitions, formats, and data
collection infrastructure.--States not receiving grants
under this section may also use the common definitions,
formats, and data collection infrastructure developed
under paragraph (2)(B).
(g) Evaluation.--
(1) In general.--The Secretary, in consultation
with the review panel established under subsection
(d)(2), shall enter into a contract with an appropriate
research organization to conduct an overall evaluation
of the effectiveness of grants awarded under subsection
(a) and to annually prepare and submit a report to
Congress. Such an evaluation shall begin not later than
18 months following the date of implementation of the
first program funded by a grant under subsection (a).
(2) Contents.--The evaluation under paragraph (1)
shall include--
(A) an analysis of the effects of the
grants awarded under subsection (a) with regard
to the measures described in paragraph (3);
(B) for each State, an analysis of the
extent to which the alternative developed under
subsection (c)(1) is effective in meeting the
elements described in subsection (c)(2);
(C) a comparison among the States receiving
grants under subsection (a) of the
effectiveness of the various alternatives
developed by such States under subsection
(c)(1);
(D) a comparison, considering the measures
described in paragraph (3), of States receiving
grants approved under subsection (a) and
similar States not receiving such grants; and
(E) a comparison, with regard to the
measures described in paragraph (3), of--
(i) States receiving grants under
subsection (a);
(ii) States that enacted, prior to
the date of enactment of the Patient
Protection and Affordable Care Act, any
cap on non-economic damages; and
(iii) States that have enacted,
prior to the date of enactment of the
Patient Protection and Affordable Care
Act, a requirement that the complainant
obtain an opinion regarding the merit
of the claim, although the substance of
such opinion may have no bearing on
whether the complainant may proceed
with a case.
(3) Measures.--The evaluations under paragraph (2)
shall analyze and make comparisons on the basis of--
(A) the nature and number of disputes over
injuries allegedly caused by health care
providers or health care organizations;
(B) the nature and number of claims in
which tort litigation was pursued despite the
existence of an alternative under subsection
(a);
(C) the disposition of disputes and claims,
including the length of time and estimated
costs to all parties;
(D) the medical liability environment;
(E) health care quality;
(F) patient safety in terms of detecting,
analyzing, and helping to reduce medical errors
and adverse events;
(G) patient and health care provider and
organization satisfaction with the alternative
under subsection (a) and with the medical
liability environment; and
(H) impact on utilization of medical
services, appropriately adjusted for risk.
(4) Funding.--The Secretary shall reserve 5 percent
of the amount appropriated in each fiscal year under
subsection (k) to carry out this subsection.
(h) MedPAC and MACPAC Reports.--
(1) MedPAC.--The Medicare Payment Advisory
Commission shall conduct an independent review of the
alternatives to current tort litigation that are
implemented under grants under subsection (a) to
determine the impact of such alternatives on the
Medicare program under title XVIII of the Social
Security Act, and its beneficiaries.
(2) MACPAC.--The Medicaid and CHIP Payment and
Access Commission shall conduct an independent review
of the alternatives to current tort litigation that are
implemented under grants under subsection (a) to
determine the impact of such alternatives on the
Medicaid or CHIP programs under titles XIX and XXI of
the Social Security Act, and their beneficiaries.
(3) Reports.--Not later than December 31, 2016, the
Medicare Payment Advisory Commission and the Medicaid
and CHIP Payment and Access Commission shall each
submit to Congress a report that includes the findings
and recommendations of each respective Commission based
on independent reviews conducted under paragraphs (1)
and (2), including an analysis of the impact of the
alternatives reviewed on the efficiency and
effectiveness of the respective programs.
(i) Option To Provide for Initial Planning Grants.--Of the
funds appropriated pursuant to subsection (k), the Secretary
may use a portion not to exceed $500,000 per State to provide
planning grants to such States for the development of
demonstration project applications meeting the criteria
described in subsection (c). In selecting States to receive
such planning grants, the Secretary shall give preference to
those States in which State law at the time of the application
would not prohibit the adoption of an alternative to current
tort litigation.
(j) Definitions.--In this section:
(1) Health care services.--The term ``health care
services'' means any services provided by a health care
provider, or by any individual working under the
supervision of a health care provider, that relate to--
(A) the diagnosis, prevention, or treatment
of any human disease or impairment; or
(B) the assessment of the health of human
beings.
(2) Health care organization.--The term ``health
care organization'' means any individual or entity
which is obligated to provide, pay for, or administer
health benefits under any health plan.
(3) Health care provider.--The term ``health care
provider'' means any individual or entity--
(A) licensed, registered, or certified
under Federal or State laws or regulations to
provide health care services; or
(B) required to be so licensed, registered,
or certified but that is exempted by other
statute or regulation.
(k) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $50,000,000 for
the 5-fiscal year period beginning with fiscal year 2011.
(l) Current State Efforts To Establish Alternative To Tort
Litigation.--Nothing in this section shall be construed to
limit any prior, current, or future efforts of any State to
establish any alternative to tort litigation.
(m) Rule of Construction.--Nothing in this section shall be
construed as limiting states' authority over or responsibility
for their state justice systems.
PART Q--PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
SEC. 399W. [280H] GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL
ACTIVITY.
(a) In General.--The Secretary, acting though the Director
of the Centers for Disease Control and Prevention, shall award
competitive grants to States and political subdivisions of
States for the development and implementation of State and
community-based intervention programs to promote good nutrition
and physical activity in children and adolescents.
(b) Eligibility.--To be eligible to receive a grant under
this section a State or political subdivision of a State shall
prepare and submit to the Secretary an application at such
time, in such manner, and containing such information as the
Secretary may require, including a plan that describes--
(1) how the applicant proposes to develop a
comprehensive program of school- and community-based
approaches to encourage and promote good nutrition and
appropriate levels of physical activity with respect to
children or adolescents in local communities;
(2) the manner in which the applicant shall
coordinate with appropriate State and local
authorities, such as State and local school
departments, State departments of health, chronic
disease directors, State directors of programs under
section 17 of the Child Nutrition Act of 1966, 5-a-day
coordinators, governors councils for physical activity
and good nutrition, and State and local parks and
recreation departments; and
(3) the manner in which the applicant will evaluate
the effectiveness of the program carried out under this
section.
(c) Use of Funds.--A State or political subdivision of a
State shall use amount received under a grant under this
section to--
(1) develop, implement, disseminate, and evaluate
school- and community-based strategies in States to
reduce inactivity and improve dietary choices among
children and adolescents;
(2) expand opportunities for physical activity
programs in school- and community-based settings; and
(3) develop, implement, and evaluate programs that
promote good eating habits and physical activity
including opportunities for children with cognitive and
physical disabilities.
(d) Technical Assistance.--The Secretary may set-aside an
amount not to exceed 10 percent of the amount appropriated for
a fiscal year under subsection (h) to permit the Director of
the Centers for Disease Control and Prevention to--
(1) provide States and political subdivisions of
States with technical support in the development and
implementation of programs under this section; and
(2) disseminate information about effective
strategies and interventions in preventing and treating
obesity through the promotion of good nutrition and
physical activity.
(e) Limitation on Administrative Costs.--Not to exceed 10
percent of the amount of a grant awarded to the State or
political subdivision under subsection (a) for a fiscal year
may be used by the State or political subdivision for
administrative expenses.
(f ) Term.--A grant awarded under subsection (a) shall be
for a term of 3 years.
(g) Definition.--In this section, the term ``children and
adolescents'' means individuals who do not exceed 18 years of
age.
(h) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.
SEC. 399X. [280H-1] APPLIED RESEARCH PROGRAM.
(a) In General.--The Secretary, acting through the Centers
for Disease Control and Prevention and in consultation with the
Director of the National Institutes of Health, shall--
(1) conduct research to better understand the
relationship between physical activity, diet, and
health and factors that influence health-related
behaviors;
(2) develop and evaluate strategies for the
prevention and treatment of obesity to be used in
community-based interventions and by health
professionals;
(3) develop and evaluate strategies for the
prevention and treatment of eating disorders, such as
anorexia and bulimia;
(4) conduct research to establish the prevalence,
consequences, and costs of childhood obesity and its
effects in adulthood;
(5) identify behaviors and risk factors that
contribute to obesity;
(6) evaluate materials and programs to provide
nutrition education to parents and teachers of children
in child care or pre-school and the food service staff
of such child care and pre-school entities; and
(7) evaluate materials and programs that are
designed to educate and encourage physical activity in
child care and pre-school facilities.
(b) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.
SEC. 399Y. [280H-2] EDUCATION CAMPAIGN.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, and in
collaboration with national, State, and local partners,
physical activity organizations, nutrition experts, and health
professional organizations, shall develop a national public
campaign to promote and educate children and their parents
concerning--
(1) the health risks associated with obesity,
inactivity, and poor nutrition;
(2) ways in which to incorporate physical activity
into daily living; and
(3) the benefits of good nutrition and strategies
to improve eating habits.
(b) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.
SEC. 399Z. [280H-3] HEALTH PROFESSIONAL EDUCATION AND TRAINING.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, in
collaboration with the Administrator of the Health Resources
and Services Administration and the heads of other agencies,
and in consultation with appropriate health professional
associations, shall develop and carry out a program to educate
and train health professionals in effective strategies to--
(1) better identify and assess patients with
obesity or an eating disorder or patients at-risk of
becoming obese or developing an eating disorder;
(2) counsel, refer, or treat patients with obesity
or an eating disorder; and
(3) educate patients and their families about
effective strategies to improve dietary habits and
establish appropriate levels of physical activity.
(b) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.
SEC. 399Z-1. [280H-5] SCHOOL-BASED HEALTH CENTERS.
(a) Definitions; Establishment of Criteria.--In this
section:
(1) Comprehensive primary health services.--The
term ``comprehensive primary health services'' means
the core services offered by school-based health
centers, which shall include the following:
(A) Physical.--Comprehensive health
assessments, diagnosis, and treatment of minor,
acute, and chronic medical conditions, and
referrals to, and follow-up for, specialty care
and oral and vision health services.
(B) Mental health.--Mental health and
substance use disorder assessments, crisis
intervention, counseling, treatment, and
referral to a continuum of services including
emergency psychiatric care, community support
programs, inpatient care, and outpatient
programs.
(2) Medically underserved children and
adolescents.--
(A) In general.--The term ``medically
underserved children and adolescents'' means a
population of children and adolescents who are
residents of an area designated as a medically
underserved area or a health professional
shortage area by the Secretary.
(B) Criteria.--The Secretary shall
prescribe criteria for determining the specific
shortages of personal health services for
medically underserved children and adolescents
under subparagraph (A) that shall--
(i) take into account any comments
received by the Secretary from the
chief executive officer of a State and
local officials in a State; and
(ii) include factors indicative of
the health status of such children and
adolescents of an area, including the
ability of the residents of such area
to pay for health services, the
accessibility of such services, the
availability of health professionals to
such children and adolescents, and
other factors as determined appropriate
by the Secretary.
(3) School-based health center.--The term ``school-
based health center'' means a health clinic that--
(A) meets the definition of a school-based
health center under section 2110(c)(9)(A) of
the Social Security Act and is administered by
a sponsoring facility (as defined in section
2110(c)(9)(B) of the Social Security Act);
(B) provides, at a minimum, comprehensive
primary health services during school hours to
children and adolescents by health
professionals in accordance with established
standards, community practice, reporting laws,
and other State laws, including parental
consent and notification laws that are not
inconsistent with Federal law; and
(C) does not perform abortion services.
(b) Authority To Award Grants.--The Secretary shall award
grants for the costs of the operation of school-based health
centers (referred to in this section as ``SBHCs'') that meet
the requirements of this section.
(c) Applications.--To be eligible to receive a grant under
this section, an entity shall--
(1) be an SBHC (as defined in subsection (a)(3));
and
(2) submit to the Secretary an application at such
time, in such manner, and containing--
(A) evidence that the applicant meets all
criteria necessary to be designated an SBHC;
(B) evidence of local need for the services
to be provided by the SBHC;
(C) an assurance that--
(i) SBHC services will be provided
to those children and adolescents for
whom parental or guardian consent has
been obtained in cooperation with
Federal, State, and local laws
governing health care service provision
to children and adolescents;
(ii) the SBHC has made and will
continue to make every reasonable
effort to establish and maintain
collaborative relationships with other
health care providers in the catchment
area of the SBHC;
(iii) the SBHC will provide on-site
access during the academic day when
school is in session and 24-hour
coverage through an on-call system and
through its backup health providers to
ensure access to services on a year-
round basis when the school or the SBHC
is closed;
(iv) the SBHC will be integrated
into the school environment and will
coordinate health services with school
personnel, such as administrators,
teachers, nurses, counselors, and
support personnel, as well as with
other community providers co-located at
the school;
(v) the SBHC sponsoring facility
assumes all responsibility for the SBHC
administration, operations, and
oversight; and
(vi) the SBHC will comply with
Federal, State, and local laws
concerning patient privacy and student
records, including regulations
promulgated under the Health Insurance
Portability and Accountability Act of
1996 and section 444 of the General
Education Provisions Act; and
(D) such other information as the Secretary
may require.
(d) Preferences and Consideration.--In reviewing
applications:
(1) The Secretary may give preference to applicants
who demonstrate an ability to serve the following:
(A) Communities that have evidenced
barriers to primary health care and mental
health and substance use disorder prevention
services for children and adolescents.
(B) Communities with high per capita
numbers of children and adolescents who are
uninsured, underinsured, or enrolled in public
health insurance programs.
(C) Populations of children and adolescents
that have historically demonstrated difficulty
in accessing health and mental health and
substance use disorder prevention services.
(2) The Secretary may give consideration to whether
an applicant has received a grant under subsection (a)
of section 4101 of the Patient Protection and
Affordable Care Act.
(e) Waiver of Requirements.--The Secretary may--
(1) under appropriate circumstances, waive the
application of all or part of the requirements of this
subsection with respect to an SBHC for not to exceed 2
years; and
(2) upon a showing of good cause, waive the
requirement that the SBHC provide all required
comprehensive primary health services for a designated
period of time to be determined by the Secretary.
(f) Use of Funds.--
(1) Funds.--Funds awarded under a grant under this
section--
(A) may be used for--
(i) acquiring and leasing equipment
(including the costs of amortizing the
principle of, and paying interest on,
loans for such equipment);
(ii) providing training related to
the provision of required comprehensive
primary health services and additional
health services;
(iii) the management and operation
of health center programs;
(iv) the payment of salaries for
physicians, nurses, and other personnel
of the SBHC; and
(B) may not be used to provide abortions.
(2) Construction.--The Secretary may award grants
which may be used to pay the costs associated with
expanding and modernizing existing buildings for use as
an SBHC, including the purchase of trailers or
manufactured buildings to install on the school
property.
(3) Limitations.--
(A) In general.--Any provider of services
that is determined by a State to be in
violation of a State law described in
subsection (a)(3)(B) with respect to activities
carried out at a SBHC shall not be eligible to
receive additional funding under this section.
(B) No overlapping grant period.--No entity
that has received funding under section 330 for
a grant period shall be eligible for a grant
under this section for with respect to the same
grant period.
(g) Matching Requirement.--
(1) In general.--Each eligible entity that receives
a grant under this section shall provide, from non-
Federal sources, an amount equal to 20 percent of the
amount of the grant (which may be provided in cash or
in-kind) to carry out the activities supported by the
grant.
(2) Waiver.--The Secretary may waive all or part of
the matching requirement described in paragraph (1) for
any fiscal year for the SBHC if the Secretary
determines that applying the matching requirement to
the SBHC would result in serious hardship or an
inability to carry out the purposes of this section.
(h) Supplement, Not Supplant.--Grant funds provided under
this section shall be used to supplement, not supplant, other
Federal or State funds.
(i) Evaluation.--The Secretary shall develop and implement
a plan for evaluating SBHCs and monitoring quality performance
under the awards made under this section.
(j) Age Appropriate Services.--An eligible entity receiving
funds under this section shall only provide age appropriate
services through a SBHC funded under this section to an
individual.
(k) Parental Consent.--An eligible entity receiving funds
under this section shall not provide services through a SBHC
funded under this section to an individual without the consent
of the parent or guardian of such individual if such individual
is considered a minor under applicable State law.
(l) Authorization of Appropriations.--For purposes of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2010 through 2014.
PART R--PROGRAMS RELATING TO AUTISM
SEC. 399AA. [280I] DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH
PROGRAM.
(a) Autism Spectrum Disorder and Other Developmental
Disabilities.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may award grants or cooperative agreements
to eligible entities for the collection, analysis, and
reporting of State epidemiological data on autism
spectrum disorder and other developmental disabilities.
An eligible entity shall assist with the development
and coordination of State autism spectrum disorder and
other developmental disability surveillance efforts
within a region. In making such awards, the Secretary
may provide direct technical assistance in lieu of
cash.
(2) Data standards.--In submitting epidemiological
data to the Secretary pursuant to paragraph (1), an
eligible entity shall report data according to
guidelines prescribed by the Director of the Centers
for Disease Control and Prevention, after consultation
with relevant State and local public health officials,
private sector developmental disability researchers,
and advocates for individuals with autism spectrum
disorder or other developmental disabilities.
(3) Eligibility.--To be eligible to receive an
award under paragraph (1), an entity shall be a public
or nonprofit private entity (including a health
department of a State or a political subdivision of a
State, a university, or any other educational
institution), and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require.
(b) Centers of Excellence in Autism Spectrum Disorder
Epidemiology.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall, subject to the availability of
appropriations, award grants or cooperative agreements
for the establishment of regional centers of excellence
in autism spectrum disorder and other developmental
disabilities epidemiology for the purpose of collecting
and analyzing information on the number, incidence,
correlates, and causes of autism spectrum disorder and
other developmental disabilities.
(2) Requirements.--To be eligible to receive a
grant or cooperative agreement under paragraph (1), an
entity shall submit to the Secretary an application
containing such agreements and information as the
Secretary may require, including an agreement that the
center to be established under the grant or cooperative
agreement shall operate in accordance with the
following:
(A) The center will collect, analyze, and
report autism spectrum disorder and other
developmental disability data according to
guidelines prescribed by the Director of the
Centers for Disease Control and Prevention,
after consultation with relevant State and
local public health officials, private sector
developmental disability researchers, and
advocates for individuals with developmental
disabilities.
(B) The center will develop or extend an
area of special research expertise (including
genetics, epigenetics, and epidemiological
research related to environmental exposures),
immunology, and other relevant research
specialty areas.
(C) The center will identify eligible cases
and controls through its surveillance system
and conduct research into factors which may
cause or increase the risk of autism spectrum
disorder and other developmental disabilities.
(c) Federal Response.--The Secretary shall coordinate the
Federal response to requests for assistance from State health,
mental health, and education department officials regarding
potential or alleged autism spectrum disorder or developmental
disability clusters.
(d) Definitions.--In this part:
(1) Other developmental disabilities.--The term
``other developmental disabilities'' has the meaning
given the term ``developmental disability'' in section
102(8) of the Developmental Disabilities Assistance and
Bill of Rights Act of 2000 (42 U.S.C. 15002(8)).
(2) State.--The term ``State'' means each of the
several States, the District of Columbia, the
Commonwealth of Puerto Rico, American Samoa, Guam, the
Commonwealth of the Northern Mariana Islands, the
Virgin Islands, and the Trust Territory of the Pacific
Islands.
(e) Sunset.--This section shall not apply after September
30, 2011.
SEC. 399BB. [280I-1] AUTISM EDUCATION, EARLY DETECTION, AND
INTERVENTION.
(a) Purpose.--It is the purpose of this section--
(1) to increase awareness, reduce barriers to
screening and diagnosis, promote evidence-based
interventions for individuals with autism spectrum
disorder or other developmental disabilities, and train
professionals to utilize valid and reliable screening
tools to diagnose or rule out and provide evidence-
based interventions for children with autism spectrum
disorder and other developmental disabilities; and
(2) to conduct activities under this section with a
focus on an interdisciplinary approach (as defined in
programs developed under section 501(a)(2) of the
Social Security Act) that will also focus on specific
issues for children who are not receiving an early
diagnosis and subsequent interventions.
(b) In General.--The Secretary shall, subject to the
availability of appropriations, establish and evaluate
activities to--
(1) provide information and education on autism
spectrum disorder and other developmental disabilities
to increase public awareness of developmental
milestones;
(2) promote research into the development and
validation of reliable screening tools for autism
spectrum disorder and other developmental disabilities
and disseminate information regarding those screening
tools;
(3) promote early screening of individuals at
higher risk for autism spectrum disorder and other
developmental disabilities as early as practicable,
given evidence-based screening techniques and
interventions;
(4) increase the number of individuals who are able
to confirm or rule out a diagnosis of autism spectrum
disorder and other developmental disabilities;
(5) increase the number of individuals able to
provide evidence-based interventions for individuals
diagnosed with autism spectrum disorder or other
developmental disabilities; and
(6) promote the use of evidence-based interventions
for individuals at higher risk for autism spectrum
disorder and other developmental disabilities as early
as practicable.
(c) Information and Education.--
(1) In general.--In carrying out subsection (b)(1),
the Secretary, in collaboration with the Secretary of
Education and the Secretary of Agriculture, shall,
subject to the availability of appropriations, provide
culturally competent information regarding autism
spectrum disorder and other developmental disabilities,
risk factors, characteristics, identification,
diagnosis or rule out, and evidence-based interventions
to meet the needs of individuals with autism spectrum
disorder or other developmental disabilities and their
families through--
(A) Federal programs, including--
(i) the Head Start program;
(ii) the Early Start program;
(iii) the Healthy Start program;
(iv) programs under the Child Care
and Development Block Grant Act of
1990;
(v) programs under title XIX of the
Social Security Act (particularly the
Medicaid Early and Periodic Screening,
Diagnosis and Treatment Program);
(vi) the program under title XXI of
the Social Security Act (the State
Children's Health Insurance Program);
(vii) the program under title V of
the Social Security Act (the Maternal
and Child Health Block Grant Program);
(viii) the program under parts B
and C of the Individuals with
Disabilities Education Act;
(ix) the special supplemental
nutrition program for women, infants,
and children established under section
17 of the Child Nutrition Act of 1966
(42 U.S.C. 1786); and
(x) the State grant program under
the Rehabilitation Act of 1973.
(B) State licensed child care facilities;
and
(C) other community-based organizations or
points of entry for individuals with autism
spectrum disorder and other developmental
disabilities to receive services.
(2) Lead agency.--
(A) Designation.--As a condition on the
provision of assistance or the conduct of
activities under this section with respect to a
State, the Secretary may require the Governor
of the State--
(i) to designate a public agency as
a lead agency to coordinate the
activities provided for under paragraph
(1) in the State at the State level;
and
(ii) acting through such lead
agency, to make available to
individuals and their family members,
guardians, advocates, or authorized
representatives; providers; and other
appropriate individuals in the State,
comprehensive culturally competent
information about State and local
resources regarding autism spectrum
disorder and other developmental
disabilities, risk factors,
characteristics, identification,
diagnosis or rule out, available
services and supports, and evidence-
based interventions.
(B) Requirements of agency.--In designating
the lead agency under subparagraph (A)(i), the
Governor shall--
(i) select an agency that has
demonstrated experience and expertise
in--
(I) autism spectrum
disorder and other
developmental disability
issues; and
(II) developing,
implementing, conducting, and
administering programs and
delivering education,
information, and referral
services (including technology-
based curriculum-development
services) to individuals with
developmental disabilities and
their family members,
guardians, advocates or
authorized representatives,
providers, and other
appropriate individuals locally
and across the State; and
(ii) consider input from
individuals with developmental
disabilities and their family members,
guardians, advocates or authorized
representatives, providers, and other
appropriate individuals.
(C) Information.--Information under
subparagraph (A)(ii) shall be provided
through--
(i) toll-free telephone numbers;
(ii) Internet websites;
(iii) mailings; or
(iv) such other means as the
Governor may require.
(d) Tools.--
(1) In general.--To promote the use of valid and
reliable screening tools for autism spectrum disorder
and other developmental disabilities, the Secretary
shall develop a curriculum for continuing education to
assist individuals in recognizing the need for valid
and reliable screening tools and the use of such tools.
(2) Collection, storage, coordination, and
availability.--The Secretary, in collaboration with the
Secretary of Education, shall provide for the
collection, storage, coordination, and public
availability of tools described in paragraph (1),
educational materials and other products that are used
by the Federal programs referred to in subsection
(c)(1)(A), as well as--
(A) programs authorized under the
Developmental Disabilities Assistance and Bill
of Rights Act of 2000;
(B) early intervention programs or
interagency coordinating councils authorized
under part C of the Individuals with
Disabilities Education Act; and
(C) children with special health care needs
programs authorized under title V of the Social
Security Act.
(3) Required sharing.--In establishing mechanisms
and entities under this subsection, the Secretary, and
the Secretary of Education, shall ensure the sharing of
tools, materials, and products developed under this
subsection among entities receiving funding under this
section.
(e) Diagnosis.--
(1) Training.--The Secretary, in coordination with
activities conducted under title V of the Social
Security Act, shall, subject to the availability of
appropriations, expand existing interdisciplinary
training opportunities or opportunities to increase the
number of sites able to diagnose or rule out
individuals with autism spectrum disorder or other
developmental disabilities and ensure that--
(A) competitive grants or cooperative
agreements are awarded to public or nonprofit
agencies, including institutions of higher
education, to expand existing or develop new
maternal and child health interdisciplinary
leadership education in neurodevelopmental and
related disabilities programs (similar to the
programs developed under section 501(a)(2) of
the Social Security Act) in States that do not
have such a program;
(B) trainees under such training programs--
(i) receive an appropriate balance
of academic, clinical, and community
opportunities;
(ii) are culturally competent;
(iii) are ethnically diverse;
(iv) demonstrate a capacity to
evaluate, diagnose or rule out,
develop, and provide evidence-based
interventions to individuals with
autism spectrum disorder and other
developmental disabilities; and
(v) demonstrate an ability to use a
family-centered approach; and
(C) program sites provide culturally
competent services.
(2) Technical assistance.--The Secretary may award
one or more grants under this section to provide
technical assistance to the network of
interdisciplinary training programs.
(3) Best practices.--The Secretary shall promote
research into additional valid and reliable tools for
shortening the time required to confirm or rule out a
diagnosis of autism spectrum disorder or other
developmental disabilities and detecting individuals
with autism spectrum disorder or other developmental
disabilities at an earlier age.
(f) Intervention.--The Secretary shall promote research,
through grants or contracts, to determine the evidence-based
practices for interventions for individuals with autism
spectrum disorder or other developmental disabilities, develop
guidelines for those interventions, and disseminate information
related to such research and guidelines.
(g) Sunset.--This section shall not apply after September
30, 2011.
SEC. 399CC. [280I-2] INTERAGENCY AUTISM COORDINATING COMMITTEE.
(a) Establishment.--The Secretary shall establish a
committee, to be known as the ``Interagency Autism Coordinating
Committee'' (in this section referred to as the ``Committee''),
to coordinate all efforts within the Department of Health and
Human Services concerning autism spectrum disorder.
(b) Responsibilities.--In carrying out its duties under
this section, the Committee shall--
(1) develop and annually update a summary of
advances in autism spectrum disorder research related
to causes, prevention, treatment, early screening,
diagnosis or rule out, intervention, and access to
services and supports for individuals with autism
spectrum disorder;
(2) monitor Federal activities with respect to
autism spectrum disorder;
(3) make recommendations to the Secretary regarding
any appropriate changes to such activities, including
recommendations to the Director of NIH with respect to
the strategic plan developed under paragraph (5);
(4) make recommendations to the Secretary regarding
public participation in decisions relating to autism
spectrum disorder;
(5) develop and annually update a strategic plan
for the conduct of, and support for, autism spectrum
disorder research, including proposed budgetary
requirements; and
(6) submit to the Congress such strategic plan and
any updates to such plan.
(c) Membership.--
(1) In general.--The Committee shall be composed
of--
(A) the Director of the Centers for Disease
Control and Prevention;
(B) the Director of the National Institutes
of Health, and the Directors of such national
research institutes of the National Institutes
of Health as the Secretary determines
appropriate;
(C) the heads of such other agencies as the
Secretary determines appropriate;
(D) representatives of other Federal
Governmental agencies that serve individuals
with autism spectrum disorder such as the
Department of Education; and
(E) the additional members appointed under
paragraph (2).
(2) Additional members.--Not fewer than 6 members
of the Committee, or 1/3 of the total membership of the
Committee, whichever is greater, shall be composed of
non-Federal public members to be appointed by the
Secretary, of which--
(A) at least one such member shall be an
individual with a diagnosis of autism spectrum
disorder;
(B) at least one such member shall be a
parent or legal guardian of an individual with
an autism spectrum disorder; and
(C) at least one such member shall be a
representative of leading research, advocacy,
and service organizations for individuals with
autism spectrum disorder.
(d) Administrative Support; Terms of Service; Other
Provisions.--The following provisions shall apply with respect
to the Committee:
(1) The Committee shall receive necessary and
appropriate administrative support from the Secretary.
(2) Members of the Committee appointed under
subsection (c)(2) shall serve for a term of 4 years,
and may be reappointed for one or more additional 4
year term. Any member appointed to fill a vacancy for
an unexpired term shall be appointed for the remainder
of such term. A member may serve after the expiration
of the member's term until a successor has taken
office.
(3) The Committee shall meet at the call of the
chairperson or upon the request of the Secretary. The
Committee shall meet not fewer than 2 times each year.
(4) All meetings of the Committee shall be public
and shall include appropriate time periods for
questions and presentations by the public.
(e) Subcommittees; Establishment and Membership.--In
carrying out its functions, the Committee may establish
subcommittees and convene workshops and conferences. Such
subcommittees shall be composed of Committee members and may
hold such meetings as are necessary to enable the subcommittees
to carry out their duties.
(f) Sunset.--This section shall not apply after September
30, 2011, and the Committee shall be terminated on such date.
SEC. 399DD. [280I-3] REPORT TO CONGRESS.
(a) In General.--Not later than 4 years after the date of
enactment of the Combating Autism Act of 2006, the Secretary,
in coordination with the Secretary of Education, shall prepare
and submit to the Health, Education, Labor, and Pensions
Committee of the Senate and the Energy and Commerce Committee
of the House of Representatives a progress report on activities
related to autism spectrum disorder and other developmental
disabilities.
(b) Contents.--The report submitted under subsection (a)
shall contain--
(1) a description of the progress made in
implementing the provisions of the Combating Autism Act
of 2006;
(2) a description of the amounts expended on the
implementation of the particular provisions of
Combating Autism Act of 2006;
(3) information on the incidence of autism spectrum
disorder and trend data of such incidence since the
date of enactment of the Combating Autism Act of 2006;
(4) information on the average age of diagnosis for
children with autism spectrum disorder and other
disabilities, including how that age may have changed
over the 4-year period beginning on the date of
enactment of this Act;
(5) information on the average age for intervention
for individuals diagnosed with autism spectrum disorder
and other developmental disabilities, including how
that age may have changed over the 4-year period
beginning on the date of enactment of this Act;
(6) information on the average time between initial
screening and then diagnosis or rule out for
individuals with autism spectrum disorder or other
developmental disabilities, as well as information on
the average time between diagnosis and evidence-based
intervention for individuals with autism spectrum
disorder or other developmental disabilities;
(7) information on the effectiveness and outcomes
of interventions for individuals diagnosed with autism
spectrum disorder, including by various subtypes, and
other developmental disabilities and how the age of the
child may affect such effectiveness;
(8) information on the effectiveness and outcomes
of innovative and newly developed intervention
strategies for individuals with autism spectrum
disorder or other developmental disabilities; and
(9) information on services and supports provided
to individuals with autism spectrum disorder and other
developmental disabilities who have reached the age of
majority (as defined for purposes of section 615(m) of
the Individuals with Disabilities Education Act (20
U.S.C. 1415(m)).
SEC. 399EE. [280I-4] AUTHORIZATION OF APPROPRIATIONS.
(a) Developmental Disabilities Surveillance and Research
Program.--To carry out section 399AA, there are authorized to
be appropriated the following:
(1) For fiscal year 2007, $15,000,000.
(2) For fiscal year 2008, $16,500,000.
(3) For fiscal year 2009, $18,000,000.
(4) For fiscal year 2010, $19,500,000.
(5) For fiscal year 2011, $21,000,000.
(b) Autism Education, Early Detection, and Intervention.--
To carry out section 399BB, there are authorized to be
appropriated the following:
(1) For fiscal year 2007, $32,000,000.
(2) For fiscal year 2008, $37,000,000.
(3) For fiscal year 2009, $42,000,000.
(4) For fiscal year 2010, $47,000,000.
(5) For fiscal year 2011, $52,000,000.
(c) Interagency Autism Coordinating Committee; Certain
Other Programs.--To carry out section 399CC, 409C, and section
404H, there are authorized to be appropriated the following:
(1) For fiscal year 2007, $100,000,000.
(2) For fiscal year 2008, $114,500,000.
(3) For fiscal year 2009, $129,000,000.
(4) For fiscal year 2010, $143,500,000.
(5) For fiscal year 2011, $158,000,000.
PART S--HEALTH CARE QUALITY PROGRAMS
Subpart I--National Strategy for Quality Improvement in Health Care
SEC. 399HH. [280J] NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH
CARE.
(a) Establishment of National Strategy and Priorities.--
(1) National strategy.--The Secretary, through a
transparent collaborative process, shall establish a
national strategy to improve the delivery of health
care services, patient health outcomes, and population
health.
(2) Identification of priorities.--
(A) In general.--The Secretary shall
identify national priorities for improvement in
developing the strategy under paragraph (1).
(B) Requirements.--The Secretary shall
ensure that priorities identified under
subparagraph (A) will--
(i) have the greatest potential for
improving the health outcomes,
efficiency, and patient-centeredness of
health care for all populations,
including children and vulnerable
populations;
(ii) identify areas in the delivery
of health care services that have the
potential for rapid improvement in the
quality and efficiency of patient care;
(iii) address gaps in quality,
efficiency, comparative effectiveness
information (taking into consideration
the limitations set forth in
subsections (c) and (d) of section 1182
of the Social Security Act), and health
outcomes measures and data aggregation
techniques;
(iv) improve Federal payment policy
to emphasize quality and efficiency;
(v) enhance the use of health care
data to improve quality, efficiency,
transparency, and outcomes;
(vi) address the health care
provided to patients with high-cost
chronic diseases;
(vii) improve research and
dissemination of strategies and best
practices to improve patient safety and
reduce medical errors, preventable
admissions and readmissions, and health
care-associated infections;
(viii) reduce health disparities
across health disparity populations (as
defined in section 485E) and geographic
areas; and
(ix) address other areas as
determined appropriate by the
Secretary.
(C) Considerations.--In identifying
priorities under subparagraph (A), the
Secretary shall take into consideration the
recommendations submitted by the entity with a
contract under section 1890(a) of the Social
Security Act and other stakeholders.
(D) Coordination with state agencies.--The
Secretary shall collaborate, coordinate, and
consult with State agencies responsible for
administering the Medicaid program under title
XIX of the Social Security Act and the
Children's Health Insurance Program under title
XXI of such Act with respect to developing and
disseminating strategies, goals, models, and
timetables that are consistent with the
national priorities identified under
subparagraph (A).
(b) Strategic Plan.--
(1) In general.--The national strategy shall
include a comprehensive strategic plan to achieve the
priorities described in subsection (a).
(2) Requirements.--The strategic plan shall include
provisions for addressing, at a minimum, the following:
(A) Coordination among agencies within the
Department, which shall include steps to
minimize duplication of efforts and utilization
of common quality measures, where available.
Such common quality measures shall be measures
identified by the Secretary under section 1139A
or 1139B of the Social Security Act or endorsed
under section 1890 of such Act.
(B) Agency-specific strategic plans to
achieve national priorities.
(C) Establishment of annual benchmarks for
each relevant agency to achieve national
priorities.
(D) A process for regular reporting by the
agencies to the Secretary on the implementation
of the strategic plan.
(E) Strategies to align public and private
payers with regard to quality and patient
safety efforts.
(F) Incorporating quality improvement and
measurement in the strategic plan for health
information technology required by the American
Recovery and Reinvestment Act of 2009 (Public
Law 111-5).
(c) Periodic Update of National Strategy.--The Secretary
shall update the national strategy not less than annually. Any
such update shall include a review of short- and long-term
goals.
(d) Submission and Availability of National Strategy and
Updates.--
(1) Deadline for initial submission of national
strategy.--Not later than January 1, 2011, the
Secretary shall submit to the relevant committees of
Congress the national strategy described in subsection
(a).
(2) Updates.--
(A) In general.--The Secretary shall submit
to the relevant committees of Congress an
annual update to the strategy described in
paragraph (1).
(B) Information submitted.--Each update
submitted under subparagraph (A) shall
include--
(i) a review of the short- and
long-term goals of the national
strategy and any gaps in such strategy;
(ii) an analysis of the progress,
or lack of progress, in meeting such
goals and any barriers to such
progress;
(iii) the information reported
under section 1139A of the Social
Security Act, consistent with the
reporting requirements of such section;
and
(iv) in the case of an update
required to be submitted on or after
January 1, 2014, the information
reported under section 1139B(b)(4) of
the Social Security Act, consistent
with the reporting requirements of such
section.
(C) Satisfaction of other reporting
requirements.--Compliance with the requirements
of clauses (iii) and (iv) of subparagraph (B)
shall satisfy the reporting requirements under
sections 1139A(a)(6) and 1139B(b)(4),
respectively, of the Social Security Act.
(e) Health Care Quality Internet Website.--Not later than
January 1, 2011, the Secretary shall create an Internet website
to make public information regarding--
(1) the national priorities for health care quality
improvement established under subsection (a)(2);
(2) the agency-specific strategic plans for health
care quality described in subsection (b)(2)(B); and
(3) other information, as the Secretary determines
to be appropriate.
SEC. 399II. [280J-1] COLLECTION AND ANALYSIS OF DATA FOR QUALITY AND
RESOURCE USE MEASURES.
(a) In General.--
(1) Establishment of strategic framework.--The
Secretary shall establish and implement an overall
strategic framework to carry out the public reporting
of performance information, as described in section
399JJ. Such strategic framework may include methods and
related timelines for implementing nationally
consistent data collection, data aggregation, and
analysis methods.
(2) Collection and aggregation of data.--The
Secretary shall collect and aggregate consistent data
on quality and resource use measures from information
systems used to support health care delivery, and may
award grants or contracts for this purpose. The
Secretary shall align such collection and aggregation
efforts with the requirements and assistance regarding
the expansion of health information technology systems,
the interoperability of such technology systems, and
related standards that are in effect on the date of
enactment of the Patient Protection and Affordable Care
Act.
(3) Scope.--The Secretary shall ensure that the
data collection, data aggregation, and analysis systems
described in paragraph (1) involve an increasingly
broad range of patient populations, providers, and
geographic areas over time.
(b) Grants or Contracts for Data Collection.--
(1) In general.--The Secretary may award grants or
contracts to eligible entities to support new, or
improve existing, efforts to collect and aggregate
quality and resource use measures described under
subsection (c).
(2) Eligible entities.--To be eligible for a grant
or contract under this subsection, an entity shall--
(A) be--
(i) a multi-stakeholder entity that
coordinates the development of methods
and implementation plans for the
consistent reporting of summary quality
and cost information;
(ii) an entity capable of
submitting such summary data for a
particular population and providers,
such as a disease registry, regional
collaboration, health plan
collaboration, or other population-wide
source; or
(iii) a Federal Indian Health
Service program or a health program
operated by an Indian tribe (as defined
in section 4 of the Indian Health Care
Improvement Act);
(B) promote the use of the systems that
provide data to improve and coordinate patient
care;
(C) support the provision of timely,
consistent quality and resource use information
to health care providers, and other groups and
organizations as appropriate, with an
opportunity for providers to correct inaccurate
measures; and
(D) agree to report, as determined by the
Secretary, measures on quality and resource use
to the public in accordance with the public
reporting process established under section
399JJ.
(c) Consistent Data Aggregation.--The Secretary may award
grants or contracts under this section only to entities that
enable summary data that can be integrated and compared across
multiple sources. The Secretary shall provide standards for the
protection of the security and privacy of patient data.
(d) Matching Funds.--The Secretary may not award a grant or
contract under this section to an entity unless the entity
agrees that it will make available (directly or through
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out
under the grant or contract in an amount equal to $1 for each
$5 of Federal funds provided under the grant or contract. Such
non-Federal matching funds may be provided directly or through
donations from public or private entities and may be in cash or
in-kind, fairly evaluated, including plant, equipment, or
services.
(e) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated such sums as
may be necessary for fiscal years 2010 through 2014.
SEC. 399JJ. [280J-2] PUBLIC REPORTING OF PERFORMANCE INFORMATION.
(a) Development of Performance Websites.--The Secretary
shall make available to the public, through standardized
Internet websites, performance information summarizing data on
quality measures. Such information shall be tailored to respond
to the differing needs of hospitals and other institutional
health care providers, physicians and other clinicians,
patients, consumers, researchers, policymakers, States, and
other stakeholders, as the Secretary may specify.
(b) Information on Conditions.--The performance information
made publicly available on an Internet website, as described in
subsection (a), shall include information regarding clinical
conditions to the extent such information is available, and the
information shall, where appropriate, be provider-specific and
sufficiently disaggregated and specific to meet the needs of
patients with different clinical conditions.
(c) Consultation.--
(1) In general.--In carrying out this section, the
Secretary shall consult with the entity with a contract
under section 1890(a) of the Social Security Act, and
other entities, as appropriate, to determine the type
of information that is useful to stakeholders and the
format that best facilitates use of the reports and of
performance reporting Internet websites.
(2) Consultation with stakeholders.--The entity
with a contract under section 1890(a) of the Social
Security Act shall convene multi-stakeholder groups, as
described in such section, to review the design and
format of each Internet website made available under
subsection (a) and shall transmit to the Secretary the
views of such multi-stakeholder groups with respect to
each such design and format.
(d) Coordination.--Where appropriate, the Secretary shall
coordinate the manner in which data are presented through
Internet websites described in subsection (a) and for public
reporting of other quality measures by the Secretary, including
such quality measures under title XVIII of the Social Security
Act.
(e) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated such sums as
may be necessary for fiscal years 2010 through 2014.
SEC. 399KK. [280J-3] QUALITY IMPROVEMENT PROGRAM FOR HOSPITALS WITH A
HIGH SEVERITY ADJUSTED READMISSION RATE.
(a) Establishment.--
(1) In general.--Not later than 2 years after the
date of enactment of this section, the Secretary shall
make available a program for eligible hospitals to
improve their readmission rates through the use of
patient safety organizations (as defined in section
921(4)).
(2) Eligible hospital defined.--In this subsection,
the term ``eligible hospital'' means a hospital that
the Secretary determines has a high rate of risk
adjusted readmissions for the conditions described in
section 1886(q)(8)(A) of the Social Security Act and
has not taken appropriate steps to reduce such
readmissions and improve patient safety as evidenced
through historically high rates of readmissions, as
determined by the Secretary.
(3) Risk adjustment.--The Secretary shall utilize
appropriate risk adjustment measures to determine
eligible hospitals.
(b) Report to the Secretary.--As determined appropriate by
the Secretary, eligible hospitals and patient safety
organizations working with those hospitals shall report to the
Secretary on the processes employed by the hospital to improve
readmission rates and the impact of such processes on
readmission rates.
PART T--ORAL HEALTHCARE PREVENTION ACTIVITIES
SEC. 399LL. [280K] ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
(a) Establishment.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in consultation with professional oral health organizations,
shall, subject to the availability of appropriations, establish
a 5-year national, public education campaign (referred to in
this section as the ``campaign'') that is focused on oral
healthcare prevention and education, including prevention of
oral disease such as early childhood and other caries,
periodontal disease, and oral cancer.
(b) Requirements.--In establishing the campaign, the
Secretary shall--
(1) ensure that activities are targeted towards
specific populations such as children, pregnant women,
parents, the elderly, individuals with disabilities,
and ethnic and racial minority populations, including
Indians, Alaska Natives and Native Hawaiians (as
defined in section 4(c) of the Indian Health Care
Improvement Act) in a culturally and linguistically
appropriate manner; and
(2) utilize science-based strategies to convey oral
health prevention messages that include, but are not
limited to, community water fluoridation and dental
sealants.
(c) Planning and Implementation.--Not later than 2 years
after the date of enactment of this section, the Secretary
shall begin implementing the 5-year campaign. During the 2-year
period referred to in the previous sentence, the Secretary
shall conduct planning activities with respect to the campaign.
SEC. 399LL-1. [280K-1] RESEARCH-BASED DENTAL CARIES DISEASE MANAGEMENT.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall award
demonstration grants to eligible entities to demonstrate the
effectiveness of research-based dental caries disease
management activities.
(b) Eligibility.--To be eligible for a grant under this
section, an entity shall--
(1) be a community-based provider of dental
services (as defined by the Secretary), including a
Federally-qualified health center, a clinic of a
hospital owned or operated by a State (or by an
instrumentality or a unit of government within a
State), a State or local department of health, a dental
program of the Indian Health Service, an Indian tribe
or tribal organization, or an urban Indian organization
(as such terms are defined in section 4 of the Indian
Health Care Improvement Act), a health system provider,
a private provider of dental services, medical, dental,
public health, nursing, nutrition educational
institutions, or national organizations involved in
improving children's oral health; and
(2) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require.
(c) Use of Funds.--A grantee shall use amounts received
under a grant under this section to demonstrate the
effectiveness of research-based dental caries disease
management activities.
(d) Use of Information.--The Secretary shall utilize
information generated from grantees under this section in
planning and implementing the public education campaign under
section 399LL.
SEC. 399LL-2. [280K-2] AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out this
part, such sums as may be necessary.
PART U--EMPLOYER-BASED WELLNESS PROGRAM
SEC. 399MM. [280L] TECHNICAL ASSISTANCE FOR EMPLOYER-BASED WELLNESS
PROGRAMS.
In order to expand the utilization of evidence-based
prevention and health promotion approaches in the workplace,
the Director shall--
(1) provide employers (including small, medium, and
large employers, as determined by the Director) with
technical assistance, consultation, tools, and other
resources in evaluating such employers' employer-based
wellness programs, including--
(A) measuring the participation and methods
to increase participation of employees in such
programs;
(B) developing standardized measures that
assess policy, environmental and systems
changes necessary to have a positive health
impact on employees' health behaviors, health
outcomes, and health care expenditures; and
(C) evaluating such programs as they relate
to changes in the health status of employees,
the absenteeism of employees, the productivity
of employees, the rate of workplace injury, and
the medical costs incurred by employees; and
(2) build evaluation capacity among workplace staff
by training employers on how to evaluate employer-based
wellness programs and ensuring evaluation resources,
technical assistance, and consultation are available to
workplace staff as needed through such mechanisms as
web portals, call centers, or other means.
SEC. 399MM-1. [280L-1] NATIONAL WORKSITE HEALTH POLICIES AND PROGRAMS
STUDY.
(a) In General.--In order to assess, analyze, and monitor
over time data about workplace policies and programs, and to
develop instruments to assess and evaluate comprehensive
workplace chronic disease prevention and health promotion
programs, policies and practices, not later than 2 years after
the date of enactment of this part, and at regular intervals
(to be determined by the Director) thereafter, the Director
shall conduct a national worksite health policies and programs
survey to assess employer-based health policies and programs.
(b) Report.--Upon the completion of each study under
subsection (a), the Director shall submit to Congress a report
that includes the recommendations of the Director for the
implementation of effective employer-based health policies and
programs.
SEC. 399MM-2. [280L-2] PRIORITIZATION OF EVALUATION BY SECRETARY.
The Secretary shall evaluate, in accordance with this part,
all programs funded through the Centers for Disease Control and
Prevention before conducting such an evaluation of privately
funded programs unless an entity with a privately funded
wellness program requests such an evaluation.
SEC. 399MM-3. [280L-3] PROHIBITION OF FEDERAL WORKPLACE WELLNESS
REQUIREMENTS.
Notwithstanding any other provision of this part, any
recommendations, data, or assessments carried out under this
part shall not be used to mandate requirements for workplace
wellness programs.
PART V--PROGRAMS RELATING TO BREAST HEALTH AND CANCER
SEC. 399NN. [280M] YOUNG WOMEN'S BREAST HEALTH AWARENESS AND SUPPORT OF
YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.
(a) Public Education Campaign.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall conduct a national evidence-based
education campaign to increase awareness of young
women's knowledge regarding--
(A) breast health in young women of all
racial, ethnic, and cultural backgrounds;
(B) breast awareness and good breast health
habits;
(C) the occurrence of breast cancer and the
general and specific risk factors in women who
may be at high risk for breast cancer based on
familial, racial, ethnic, and cultural
backgrounds such as Ashkenazi Jewish
populations;
(D) evidence-based information that would
encourage young women and their health care
professional to increase early detection of
breast cancers; and
(E) the availability of health information
and other resources for young women diagnosed
with breast cancer.
(2) Evidence-based, age appropriate messages.--The
campaign shall provide evidence-based, age-appropriate
messages and materials as developed by the Centers for
Disease Control and Prevention and the Advisory
Committee established under paragraph (4).
(3) Media campaign.--In conducting the education
campaign under paragraph (1), the Secretary shall award
grants to entities to establish national multimedia
campaigns oriented to young women that may include
advertising through television, radio, print media,
billboards, posters, all forms of existing and
especially emerging social networking media, other
Internet media, and any other medium determined
appropriate by the Secretary.
(4) Advisory committee.--
(A) Establishment.--Not later than 60 days
after the date of the enactment of this
section, the Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall establish an advisory
committee to assist in creating and conducting
the education campaigns under paragraph (1) and
subsection (b)(1).
(B) Membership.--The Secretary, acting
through the Director of the Centers for Disease
Control and Prevention, shall appoint to the
advisory committee under subparagraph (A) such
members as deemed necessary to properly advise
the Secretary, and shall include organizations
and individuals with expertise in breast
cancer, disease prevention, early detection,
diagnosis, public health, social marketing,
genetic screening and counseling, treatment,
rehabilitation, palliative care, and
survivorship in young women.
(b) Health Care Professional Education Campaign.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, and in consultation with the
Administrator of the Health Resources and Services
Administration, shall conduct an education campaign among
physicians and other health care professionals to increase
awareness--
(1) of breast health, symptoms, and early diagnosis
and treatment of breast cancer in young women,
including specific risk factors such as family history
of cancer and women that may be at high risk for breast
cancer, such as Ashkenazi Jewish population;
(2) on how to provide counseling to young women
about their breast health, including knowledge of their
family cancer history and importance of providing
regular clinical breast examinations;
(3) concerning the importance of discussing healthy
behaviors, and increasing awareness of services and
programs available to address overall health and
wellness, and making patient referrals to address
tobacco cessation, good nutrition, and physical
activity;
(4) on when to refer patients to a health care
provider with genetics expertise;
(5) on how to provide counseling that addresses
long-term survivorship and health concerns of young
women diagnosed with breast cancer; and
(6) on when to provide referrals to organizations
and institutions that provide credible health
information and substantive assistance and support to
young women diagnosed with breast cancer.
(c) Prevention Research Activities.--The Secretary, acting
through--
(1) the Director of the Centers for Disease Control
and Prevention, shall conduct prevention research on
breast cancer in younger women, including--
(A) behavioral, survivorship studies, and
other research on the impact of breast cancer
diagnosis on young women;
(B) formative research to assist with the
development of educational messages and
information for the public, targeted
populations, and their families about breast
health, breast cancer, and healthy lifestyles;
(C) testing and evaluating existing and new
social marketing strategies targeted at young
women; and
(D) surveys of health care providers and
the public regarding knowledge, attitudes, and
practices related to breast health and breast
cancer prevention and control in high-risk
populations; and
(2) the Director of the National Institutes of
Health, shall conduct research to develop and validate
new screening tests and methods for prevention and
early detection of breast cancer in young women.
(d) Support for Young Women Diagnosed With Breast Cancer.--
(1) In general.--The Secretary shall award grants
to organizations and institutions to provide health
information from credible sources and substantive
assistance directed to young women diagnosed with
breast cancer and pre-neoplastic breast diseases.
(2) Priority.--In making grants under paragraph
(1), the Secretary shall give priority to applicants
that deal specifically with young women diagnosed with
breast cancer and pre-neoplastic breast disease.
(e) No Duplication of Effort.--In conducting an education
campaign or other program under subsections (a), (b), (c), or
(d), the Secretary shall avoid duplicating other existing
Federal breast cancer education efforts.
(f) Measurement; Reporting.--The Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall--
(1) measure--
(A) young women's awareness regarding
breast health, including knowledge of family
cancer history, specific risk factors and early
warning signs, and young women's proactive
efforts at early detection;
(B) the number or percentage of young women
utilizing information regarding lifestyle
interventions that foster healthy behaviors;
(C) the number or percentage of young women
receiving regular clinical breast exams; and
(D) the number or percentage of young women
who perform breast self exams, and the
frequency of such exams, before the
implementation of this section;
(2) not less than every 3 years, measure the impact
of such activities; and
(3) submit reports to the Congress on the results
of such measurements.
(g) Definition.--In this section, the term ``young women''
means women 15 to 44 years of age.
(h) Authorization of Appropriations.--To carry out
subsections (a), (b), (c)(1), and (d), there are authorized to
be appropriated $9,000,000 for each of the fiscal years 2010
through 2014.ATTORNEY: pmg/FD (June 24, 1999) deg.
TITLE IV--NATIONAL RESEARCH INSTITUTES
Part A--National Institutes of Health
SEC. 401. [281] ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
(a) Relation to Public Health Service.--The National
Institutes of Health is an agency of the Service. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 202.
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(b) National Research Institutes and National Centers.--The
following agencies of the National Institutes of Health are
national research institutes or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and
Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and
Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and
Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute
of Child Health and Human Development.
(8) The National Institute of Dental and
Craniofacial Research. \2\
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\2\ Section 212 of the Departments of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act, 1999
(as contained in section 101(f) of division A of Public Law 105-277;
112 Stat. 2681-359) amended subparagraph (H) to read as provided above,
thereby indicating the intent of the Congress to change the designation
of the Institute. (The former designation was the National Institute of
Dental Research.) Conforming changes were not, however, made to section
453 or the related subpart heading, or to the reference in section
409A(a).
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(9) The National Eye Institute.
(10) The National Institute of Neurological
Disorders and Stroke.
(11) The National Institute on Deafness and Other
Communication Disorders.
(12) The National Institute on Alcohol Abuse and
Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical
Sciences.
(16) The National Institute of Environmental Health
Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical Imaging
and Bioengineering.
(19) The National Human Genome Research Institute.
(20) The National Library of Medicine.
(21) The National Center for Research Resources.
(22) The John E. Fogarty International Center for
Advanced Study in the Health Sciences.
(23) The National Center for Complementary and
Alternative Medicine.
(24) The National Institute on Minority Health and
Health Disparities.
(25) Any other national center that, as an agency
separate from any national research institute, was
established within the National Institutes of Health as
of the day before the date of the enactment of the
National Institutes of Health Reform Act of 2006.
(c) Division of Program Coordination, Planning, and
Strategic Initiatives.--
(1) In general.--Within the Office of the Director
of the National Institutes of Health, there shall be a
Division of Program Coordination, Planning, and
Strategic Initiatives (referred to in this subsection
as the ``Division'').
(2) Offices within division.--
(A) Offices.--The following offices are
within the Division: The Office of AIDS
Research, the Office of Research on Women's
Health, the Office of Behavioral and Social
Sciences Research, the Office of Disease
Prevention, the Office of Dietary Supplements,
the Office of Rare Diseases, and any other
office located within the Office of the
Director of NIH as of the day before the date
of the enactment of the National Institutes of
Health Reform Act of 2006. In addition to such
offices, the Director of NIH may establish
within the Division such additional offices or
other administrative units as the Director
determines to be appropriate.
(B) Authorities.--Each office in the
Division--
(i) shall continue to carry out the
authorities that were in effect for the
office before the date of enactment
referred to in subparagraph (A); and
(ii) shall, as determined
appropriate by the Director of NIH,
support the Division with respect to
the authorities described in section
402(b)(7).
(d) Organization.--
(1) Number of institutes and centers.--In the
National Institutes of Health, the number of national
research institutes and national centers may not exceed
a total of 27, including any such institutes or centers
established under authority of paragraph (2) or under
authority of this title as in effect on the day before
the date of the enactment of the National Institutes of
Health Reform Act of 2006.
(2) Reorganization of institutes.--
(A) In general.--The Secretary may
establish in the National Institutes of Health
one or more additional national research
institutes to conduct and support research,
training, health information, and other
programs with respect to any particular disease
or groups of diseases or any other aspect of
human health if--
(i) the Secretary determines that
an additional institute is necessary to
carry out such activities; and
(ii) the additional institute is
not established before the expiration
of 180 days after the Secretary has
provided the Committee on Energy and
Commerce of the House of
Representatives and the Committee on
Health, Education, Labor, and Pensions
of the Senate written notice of the
determination made under clause (i)
with respect to the institute.
(B) Additional authority.--The Secretary
may reorganize the functions of any national
research institute and may abolish any national
research institute if the Secretary determines
that the institute is no longer required. A
reorganization or abolition may not take effect
under this paragraph before the expiration of
180 days after the Secretary has provided the
Committee on Energy and Commerce of the House
of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate
written notice of the reorganization or
abolition.
(3) Reorganization of office of director.--
Notwithstanding subsection (c), the Director of NIH
may, after a series of public hearings, and with the
approval of the Secretary, reorganize the offices
within the Office of the Director, including the
addition, removal, or transfer of functions of such
offices, and the establishment or termination of such
offices, if the Director determines that the overall
management and operation of programs and activities
conducted or supported by such offices would be more
efficiently carried out under such a reorganization.
(4) Internal reorganization of institutes and
centers.--Notwithstanding any conflicting provisions of
this title, the director of a national research
institute or a national center may, after a series of
public hearings and with the approval of the Director
of NIH, reorganize the divisions, centers, or other
administrative units within such institute or center,
including the addition, removal, or transfer of
functions of such units, and the establishment or
termination of such units, if the director of such
institute or center determines that the overall
management and operation of programs and activities
conducted or supported by such divisions, centers, or
other units would be more efficiently carried out under
such a reorganization.
(e) Scientific Management Review Board for Periodic
Organizational Reviews.--
(1) In general.--Not later than 60 days after the
date of the enactment of the National Institutes of
Health Reform Act of 2006, the Secretary shall
establish an advisory council within the National
Institutes of Health to be known as the Scientific
Management Review Board (referred to in this subsection
as the ``Board'').
(2) Duties.--
(A) Reports on organizational issues.--The
Board shall provide advice to the appropriate
officials under subsection (d) regarding the
use of the authorities established in
paragraphs (2), (3), and (4) of such subsection
to reorganize the National Institutes of Health
(referred to in this subsection as
``organizational authorities''). Not less
frequently than once each 7 years, the Board
shall--
(i) determine whether and to what
extent the organizational authorities
should be used; and
(ii) issue a report providing the
recommendations of the Board regarding
the use of the authorities and the
reasons underlying the recommendations.
(B) Certain responsibilities regarding
reports.--The activities of the Board with
respect to a report under subparagraph (A)
shall include the following:
(i) Reviewing the research
portfolio of the National Institutes of
Health (referred to in this subsection
as ``NIH'') in order to determine the
progress and effectiveness and value of
the portfolio and the allocation among
the portfolio activities of the
resources of NIH.
(ii) Determining pending scientific
opportunities, and public health needs,
with respect to research within the
jurisdiction of NIH.
(iii) For any proposal for
organizational changes to which the
Board gives significant consideration
as a possible recommendation in such
report--
(I) analyzing the budgetary
and operational consequences of
the proposed changes;
(II) taking into account
historical funding and support
for research activities at
national research institutes
and centers that have been
established recently relative
to national research institutes
and centers that have been in
existence for more than two
decades;
(III) estimating the level
of resources needed to
implement the proposed changes;
(IV) assuming the proposed
changes will be made and making
a recommendation for the
allocation of the resources of
NIH among the national research
institutes and national
centers; and
(V) analyzing the
consequences for the progress
of research in the areas
affected by the proposed
changes.
(C) Consultation.--In carrying out
subparagraph (A), the Board shall consult
with--
(i) the heads of national research
institutes and national centers whose
directors are not members of the Board;
(ii) other scientific leaders who
are officers or employees of NIH and
are not members of the Board;
(iii) advisory councils of the
national research institutes and
national centers;
(iv) organizations representing the
scientific community; and
(v) organizations representing
patients.
(3) Composition of board.--The Board shall consist
of the Director of NIH, who shall be a permanent
nonvoting member on an ex officio basis, and an odd
number of additional members, not to exceed 21, all of
whom shall be voting members. The voting members of the
Board shall be the following:
(A) Not fewer than 9 officials who are
directors of national research institutes or
national centers. The Secretary shall designate
such officials for membership and shall ensure
that the group of officials so designated
includes directors of--
(i) national research institutes
whose budgets are substantial relative
to a majority of the other institutes;
(ii) national research institutes
whose budgets are small relative to a
majority of the other institutes;
(iii) national research institutes
that have been in existence for a
substantial period of time without
significant organizational change under
subsection (d);
(iv) as applicable, national
research institutes that have undergone
significant organization changes under
such subsection, or that have been
established under such subsection,
other than national research institutes
for which such changes have been in
place for a substantial period of time;
and
(v) national centers.
(B) Members appointed by the Secretary from
among individuals who are not officers or
employees of the United States. Such members
shall include--
(i) individuals representing the
interests of public or private
institutions of higher education that
have historically received funds from
NIH to conduct research; and
(ii) individuals representing the
interests of private entities that have
received funds from NIH to conduct
research or that have broad expertise
regarding how the National Institutes
of Health functions, exclusive of
private entities to which clause (i)
applies.
(4) Chair.--The Chair of the Board shall be
selected by the Secretary from among the members of the
Board appointed under paragraph (3)(B). The term of
office of the Chair shall be 2 years.
(5) Meetings.--
(A) In general.--The Board shall meet at
the call of the Chair or upon the request of
the Director of NIH, but not fewer than 5 times
with respect to issuing any particular report
under paragraph (2)(A). The location of the
meetings of the Board is subject to the
approval of the Director of NIH.
(B) Particular forums.--Of the meetings
held under subparagraph (A) with respect to a
report under paragraph (2)(A)--
(i) one or more shall be directed
toward the scientific community to
address scientific needs and
opportunities related to proposals for
organizational changes under subsection
(d), or as the case may be, related to
a proposal that no such changes be
made; and
(ii) one or more shall be directed
toward consumer organizations to
address the needs and opportunities of
patients and their families with
respect to proposals referred to in
clause (i).
(C) Availability of information from
forums.--For each meeting under subparagraph
(B), the Director of NIH shall post on the
Internet site of the National Institutes of
Health a summary of the proceedings.
(6) Compensation; term of office.--The provisions
of subsections (b)(4) and (c) of section 406 apply with
respect to the Board to the same extent and in the same
manner as such provisions apply with respect to an
advisory council referred to in such subsections,
except that the reference in such subsection (c) to 4
years regarding the term of an appointed member is
deemed to be a reference to 5 years.
(7) Reports.--
(A) Recommendations for changes.--Each
report under paragraph (2)(A) shall be
submitted to--
(i) the Committee on Energy and
Commerce and the Committee on
Appropriations of the House of
Representatives;
(ii) the Committee on Health,
Education, Labor, and Pensions and the
Committee on Appropriations of the
Senate;
(iii) the Secretary; and
(iv) officials with organizational
authorities, other than any such
official who served as a member of the
Board with respect to the report
involved.
(B) Availability to public.--The Director
of NIH shall post each report under paragraph
(2) on the Internet site of the National
Institutes of Health.
(C) Report on board activities.--Not later
than 18 months after the date of the enactment
of the National Institutes of Health Reform Act
of 2006, the Board shall submit to the
committees specified in subparagraph (A) a
report describing the activities of the Board.
(f) Organizational Changes per Recommendation of Scientific
Management Review Board.--
(1) In general.--With respect to an official who
has organizational authorities within the meaning of
subsection (e)(2)(A), if a recommendation to the
official for an organizational change is made in a
report under such subsection, the official shall,
except as provided in paragraphs (2), (3), and (4) of
this subsection, make the change in accordance with the
following:
(A) Not later than 100 days after the
report is submitted under subsection (e)(7)(A),
the official shall initiate the applicable
public process required in subsection (d)
toward making the change.
(B) The change shall be fully implemented
not later than the expiration of the 3-year
period beginning on the date on which such
process is initiated.
(2) Inapplicability to certain reorganizations.--
Paragraph (1) does not apply to a recommendation made
in a report under subsection (e)(2)(A) if the
recommendation is for--
(A) an organizational change under
subsection (d)(2) that constitutes the
establishment, termination, or consolidation of
one or more national research institutes or
national centers; or
(B) an organizational change under
subsection (d)(3).
(3) Objection by director of nih.--
(A) In general.--Paragraph (1) does not
apply to a recommendation for an organizational
change made in a report under subsection
(e)(2)(A) if, not later than 90 days after the
report is submitted under subsection (e)(7)(A),
the Director of NIH submits to the committees
specified in such subsection a report providing
that the Director objects to the change, which
report includes the reasons underlying the
objection.
(B) Scope of objection.--For purposes of
subparagraph (A), an objection by the Director
of NIH may be made to the entirety of a
recommended organizational change or to 1 or
more aspects of the change. Any aspect of a
change not objected to by the Director in a
report under subparagraph (A) shall be
implemented in accordance with paragraph (1).
(4) Congressional review.--An organizational change
under subsection (d)(2) that is initiated pursuant to
paragraph (1) shall be carried out by regulation in
accordance with the procedures for substantive rules
under section 553 of title 5, United States Code. A
rule under the preceding sentence shall be considered a
major rule for purposes of chapter 8 of such title
(relating to congressional review of agency
rulemaking).
(g) Definitions.--For purposes of this title:
(1) The term ``Director of NIH'' means the Director
of the National Institutes of Health.
(2) The terms ``national research institute'' and
``national center'' mean an agency of the National
Institutes of Health that is--
(A) listed in subsection (b) and not
terminated under subsection (d)(2)(A); or
(B) established by the Director of NIH
under such subsection.
(h) References to NIH.--For purposes of this title, a
reference to the National Institutes of Health includes its
agencies.
appointment and authority of director of nih
Sec. 402. [282] (a) The National Institutes of Health shall
be headed by the Director of NIH who shall be appointed by the
President by and with the advice and consent of the Senate. The
Director of NIH shall perform functions as provided under
subsection (b) and as the Secretary may otherwise prescribe.
(b) In carrying out the purposes of section 301, the
Secretary, acting through the Director of NIH--
(1) shall carry out this title, including being
responsible for the overall direction of the National
Institutes of Health and for the establishment and
implementation of general policies respecting the
management and operation of programs and activities
within the National Institutes of Health;
(2) shall coordinate and oversee the operation of
the national research institutes, national centers, and
administrative entities within the National Institutes
of Health;
(3) shall, in consultation with the heads of the
national research institutes and national centers, be
responsible for program coordination across the
national research institutes and national centers,
including conducting priority-setting reviews, to
ensure that the research portfolio of the National
Institutes of Health is balanced and free of
unnecessary duplication, and takes advantage of
collaborative, cross-cutting research;
(4) shall assemble accurate data to be used to
assess research priorities, including information to
better evaluate scientific opportunity, public health
burdens, and progress in reducing minority and other
health disparities;
(5) shall ensure that scientifically based
strategic planning is implemented in support of
research priorities as determined by the agencies of
the National Institutes of Health;
(6) shall ensure that the resources of the National
Institutes of Health are sufficiently allocated for
research projects identified in strategic plans;
(7)(A) shall, through the Division of Program
Coordination, Planning, and Strategic Initiatives--
(i) identify research that represents
important areas of emerging scientific
opportunities, rising public health challenges,
or knowledge gaps that deserve special emphasis
and would benefit from conducting or supporting
additional research that involves collaboration
between 2 or more national research institutes
or national centers, or would otherwise benefit
from strategic coordination and planning;
(ii) include information on such research
in reports under section 403; and
(iii) in the case of such research
supported with funds referred to in
subparagraph (B)--
(I) require as appropriate that
proposals include milestones and goals
for the research;
(II) require that the proposals
include timeframes for funding of the
research; and
(III) ensure appropriate
consideration of proposals for which
the principal investigator is an
individual who has not previously
served as the principal investigator of
research conducted or supported by the
National Institutes of Health;
(B) may, with respect to funds reserved under
section 402A(c)(1) for the Common Fund, allocate such
funds to the national research institutes and national
centers for conducting and supporting research that is
identified under subparagraph (A); and
(C) may assign additional functions to the Division
in support of responsibilities identified in
subparagraph (A), as determined appropriate by the
Director;
(8) shall, in coordination with the heads of the
national research institutes and national centers,
ensure that such institutes and centers--
(A) preserve an emphasis on investigator-
initiated research project grants, including
with respect to research involving
collaboration between 2 or more such institutes
or centers; and
(B) when appropriate, maximize
investigator-initiated research project grants
in their annual research portfolios;
(9) shall ensure that research conducted or
supported by the National Institutes of Health is
subject to review in accordance with section 492 and
that, after such review, the research is reviewed in
accordance with section 492A(a)(2) by the appropriate
advisory council under section 406 before the research
proposals are approved for funding;
(10) shall have authority to review and approve the
establishment of all centers of excellence recommended
by the national research institutes;
(11)(A) shall oversee research training for all of
the national research institutes and National Research
Service Awards in accordance with section 487; and
(B) may conduct and support research training--
(i) for which fellowship support is not
provided under section 487; and
(ii) that does not consist of residency
training of physicians or other health
professionals;
(12) may, from funds appropriated under section
402A(b), reserve funds to provide for research on
matters that have not received significant funding
relative to other matters, to respond to new issues and
scientific emergencies, and to act on research
opportunities of high priority;
(13) may, subject to appropriations Acts, collect
and retain registration fees obtained from third
parties to defray expenses for scientific, educational,
and research-related conferences;
(14) for the national research institutes and
administrative entities within the National Institutes
of Health--
(A) may acquire, construct, improve,
repair, operate, and maintain, at the site of
such institutes and entities, laboratories, and
other research facilities, other facilities,
equipment, and other real or personal property,
and
(B) may acquire, without regard to the Act
of March 3, 1877 (40 U.S.C. 34), by lease or
otherwise through the Administrator of General
Services, buildings or parts of buildings in
the District of Columbia or communities located
adjacent to the District of Columbia for use
for a period not to exceed ten years;
(15) may secure resources for research conducted by
or through the National Institutes of Health;
(16) may, without regard to the provisions of title
5, United States Code, governing appointments in the
competitive service, and without regard to the
provisions of chapter 51 and subchapter III of chapter
53 of such title relating to classification and General
Schedule pay rates, establish such technical and
scientific peer review groups and scientific program
advisory committees as are needed to carry out the
requirements of this title and appoint and pay the
members of such groups, except that officers and
employees of the United States shall not receive
additional compensation for service as members of such
groups;
(17) may secure for the National Institutes of
Health consultation services and advice of persons from
the United States or abroad;
(18) may use, with their consent, the services,
equipment, personnel, information, and facilities of
other Federal, State, or local public agencies, with or
without reimbursement therefor;
(19) may, for purposes of study, admit and treat at
facilities of the National Institutes of Health
individuals not otherwise eligible for such treatment;
(20) may accept voluntary and uncompensated
services;
(21) may perform such other administrative
functions as the Secretary determines are needed to
effectively carry out this title;
(22) may appoint physicians, dentists, and other
health care professionals, subject to the provisions of
title 5, United States Code, relating to appointments
and classifications in the competitive service, and may
compensate such professionals subject to the provisions
of chapter 74 of title 38, United States Code;
(23) shall designate a contact point or office to
help innovators and physicians identify sources of
funding available for pediatric medical device
development; and
(24) implement the Cures Acceleration Network
described in section 402C.
The Federal Advisory Committee Act shall not apply to the
duration of a peer review group appointed under paragraph (16).
The members of such a group shall be individuals who by virtue
of their training or experience are eminently qualified to
perform the review functions of such group. Not more than one-
fourth of the members of any such group shall be officers or
employees of the United States.
(c) The Director of NIH may make available to individuals
and entities, for biomedical and behavioral research,
substances and living organisms. Such substances and organisms
shall be made available under such terms and conditions
(including payment for them) as the Secretary determines
appropriate.
(d)(1) The Director of NIH may obtain (in accordance with
section 3109 of title 5, United States Code, but without regard
to the limitation in such section on the period of service) the
services of not more than 220 experts or consultants, with
scientific or other professional qualifications, for the
National Institutes of Health.
(2)(A) Except as provided in subparagraph (B), experts and
consultants whose services are obtained under paragraph (1)
shall be paid or reimbursed, in accordance with title 5, United
States Code, for their travel to and from their place of
service and for other expenses associated with their
assignment.
(B) Expenses specified in subparagraph (A) shall not be
allowed in connection with the assignment of an expert or
consultant whose services are obtained under paragraph (1)
unless the expert or consultant has agreed in writing to
complete the entire period of the assignment or one year of the
assignment, whichever is shorter, unless separated or
reassigned for reasons which are beyond the control of the
expert or consultant and which are acceptable to the Secretary.
If the expert or consultant violates the agreement, the money
spent by the United States for such expenses is recoverable
from the expert or consultant as a debt due the United States.
The Secretary may waive in whole or in part a right of recovery
under this subparagraph.
(e) The Director of NIH shall--
(1) advise the agencies of the National Institutes
of Health on medical applications of research;
(2) coordinate, review, and facilitate the
systematic identification and evaluation of, clinically
relevant information from research conducted by or
through the national research institutes;
(3) promote the effective transfer of the
information described in paragraph (2) to the health
care community and to entities that require such
information;
(4) monitor the effectiveness of the activities
described in paragraph (3); and
(5) ensure that, after January 1, 1994, all new or
revised health education and promotion materials
developed or funded by the National Institutes of
Health and intended for the general public are in a
form that does not exceed a level of functional
literacy, as defined in the National Literacy Act of
1991 (Public Law 102-73) \1\.
---------------------------------------------------------------------------
\1\ So in law. That Act was repealed by section 251(a)(2) of Public
Law 105-220 (112 Stat. 1079).
---------------------------------------------------------------------------
(f) There shall be in the National Institutes of Health an
Associate Director for Prevention. The Director of NIH shall
delegate to the Associate Director for Prevention the functions
of the Director relating to the promotion of the disease
prevention research programs of the national research
institutes and the coordination of such programs among the
national research institutes and between the national research
institutes and other public and private entities, including
elementary, secondary, and post-secondary schools. The
Associate Director shall--
(1) annually review the efficacy of existing
policies and techniques used by the national research
institutes to disseminate the results of disease
prevention and behavioral research programs; and
(2) recommend, coordinate, and oversee the
modification or reconstruction of such policies and
techniques to ensure maximum dissemination, using
advanced technologies to the maximum extent
practicable, of research results to such entities.
(g)(1)(A) In the case of entities described in subparagraph
(B), the Director of NIH, acting through the Director of the
National Center for Research Resources, shall establish a
program to enhance the competitiveness of such entities in
obtaining funds from the national research institutes for
conducting biomedical and behavioral research.
(B) The entities referred to in subparagraph (A) are
entities that conduct biomedical and behavioral research and
are located in a State in which the aggregate success rate for
applications to the national research institutes for assistance
for such research by the entities in the State has historically
constituted a low success rate of obtaining such funds,
relative to such aggregate rate for such entities in other
States.
(C) With respect to enhancing competitiveness for purposes
of subparagraph (A), the Director of NIH, in carrying out the
program established under such subparagraph, may--
(i) provide technical assistance to the entities
involved, including technical assistance in the
preparation of applications for obtaining funds from
the national research institutes;
(ii) assist the entities in developing a plan for
biomedical or behavioral research proposals; and
(iii) assist the entities in implementing such
plan.
(2) The Director of NIH shall establish a program of
supporting projects of biomedical or behavioral research whose
principal researchers are individuals who have not previously
served as the principal researchers of such projects supported
by the Director.
(h) The Secretary, acting through the Director of NIH and
the Directors of the agencies of the National Institutes of
Health, shall, in conducting and supporting programs for
research, research training, recruitment, and other activities,
provide for an increase in the number of women and individuals
from disadvantaged backgrounds (including racial and ethnic
minorities) in the fields of biomedical and behavioral
research.
(i)(1)(A) The Secretary, acting through the Director of
NIH, shall establish, maintain, and operate a data bank of
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection
referred to as the ``data bank''). The activities of the data
bank shall be integrated and coordinated with related
activities of other agencies of the Department of Health and
Human Services, and to the extent practicable, coordinated with
other data banks containing similar information.
(B) The Secretary shall establish the data bank after
consultation with the Commissioner of Food and Drugs, the
directors of the appropriate agencies of the National
Institutes of Health (including the National Library of
Medicine), and the Director of the Centers for Disease Control
and Prevention.
(2) In carrying out paragraph (1), the Secretary shall
collect, catalog, store, and disseminate the information
described in such paragraph. The Secretary shall disseminate
such information through information systems, which shall
include toll-free telephone communications, available to
individuals with serious or life-threatening diseases and
conditions, to other members of the public, to health care
providers, and to researchers.
(3) The data bank shall include the following:
(A) A registry of clinical trials (whether
federally or privately funded) of experimental
treatments for serious or life-threatening diseases and
conditions under regulations promulgated pursuant to
section 505(i) of the Federal Food, Drug, and Cosmetic
Act, which provides a description of the purpose of
each experimental drug, either with the consent of the
protocol sponsor, or when a trial to test effectiveness
begins. Information provided shall consist of
eligibility criteria for participation in the clinical
trials, a description of the location of trial sites,
and a point of contact for those wanting to enroll in
the trial, and shall be in a form that can be readily
understood by members of the public. \1\ Such
information shall be forwarded to the data bank by the
sponsor of the trial not later than 21 days after the
approval of the protocol.
---------------------------------------------------------------------------
\1\ Section 15(c)(2) of Public Law 107-109 (115 Stat. 1420)
attempted to make amendments to the first sentence of subparagraph (A),
but the amendments cannot be executed because the terms to be amended
appear in the second sentence, not the first. The following shows the
second sentence as it would appear if the amendments were executed to
the second sentence: ``Information provided shall consist of
eligibility criteria for participation in the clinical trials, a
description of the location of trial sites, a point of contact for
those wanting to enroll in the trial, and a description of whether, and
through what procedure, the manufacturer or sponsor of the
investigation of a new drug will respond to requests for protocol
exception, with appropriate safeguards, for single-patient and expanded
protocol use of the new drug, particularly in children, and shall be in
a form that can be readily understood by members of the public.''.
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(B) Information pertaining to experimental
treatments for serious or life-threatening diseases and
conditions that may be available--
(i) under a treatment investigational new
drug application that has been submitted to the
Secretary under section 561(c) of the Federal
Food, Drug, and Cosmetic Act; or
(ii) as a Group C cancer drug (as defined
by the National Cancer Institute).
The data bank may also include information pertaining
to the results of clinical trials of such treatments,
with the consent of the sponsor, including information
concerning potential toxicities or adverse effects
associated with the use or administration of such
experimental treatments.
(4) The data bank shall not include information relating to
an investigation if the sponsor has provided a detailed
certification to the Secretary that disclosure of such
information would substantially interfere with the timely
enrollment of subjects in the investigation, unless the
Secretary, after the receipt of the certification, provides the
sponsor with a detailed written determination that such
disclosure would not substantially interfere with such
enrollment.
(5) Fees collected under section 736 of the Federal Food,
Drug, and Cosmetic Act shall not be used in carrying out this
subsection.
(j) Expanded Clinical Trial Registry Data Bank.--
(1) Definitions; requirement.--
(A) Definitions.--In this subsection:
(i) Applicable clinical trial.--The
term ``applicable clinical trial''
means an applicable device clinical
trial or an applicable drug clinical
trial.
(ii) Applicable device clinical
trial.--The term ``applicable device
clinical trial'' means--
(I) a prospective clinical
study of health outcomes
comparing an intervention with
a device subject to section
510(k), 515, or 520(m) of the
Federal Food, Drug, and
Cosmetic Act against a control
in human subjects (other than a
small clinical trial to
determine the feasibility of a
device, or a clinical trial to
test prototype devices where
the primary outcome measure
relates to feasibility and not
to health outcomes); and
(II) a pediatric postmarket
surveillance as required under
section 522 of the Federal
Food, Drug, and Cosmetic Act.
(iii) Applicable drug clinical
trial.--
(I) In general.--The term
``applicable drug clinical
trial'' means a controlled
clinical investigation, other
than a phase I clinical
investigation, of a drug
subject to section 505 of the
Federal Food, Drug, and
Cosmetic Act or to section 351
of this Act.
(II) Clinical
investigation.--For purposes of
subclause (I), the term
``clinical investigation'' has
the meaning given that term in
section 312.3 of title 21, Code
of Federal Regulations (or any
successor regulation).
(III) Phase i.--For
purposes of subclause (I), the
term ``phase I'' has the
meaning given that term in
section 312.21 of title 21,
Code of Federal Regulations (or
any successor regulation).
(iv) Clinical trial information.--
The term ``clinical trial information''
means, with respect to an applicable
clinical trial, those data elements
that the responsible party is required
to submit under paragraph (2) or under
paragraph (3).
(v) Completion date.--The term
``completion date'' means, with respect
to an applicable clinical trial, the
date that the final subject was
examined or received an intervention
for the purposes of final collection of
data for the primary outcome, whether
the clinical trial concluded according
to the prespecified protocol or was
terminated.
(vi) Device.--The term ``device''
means a device as defined in section
201(h) of the Federal Food, Drug, and
Cosmetic Act.
(vii) Drug.--The term ``drug''
means a drug as defined in section
201(g) of the Federal Food, Drug, and
Cosmetic Act or a biological product as
defined in section 351 of this Act.
(viii) Ongoing.--The term
``ongoing'' means, with respect to a
clinical trial of a drug or a device
and to a date, that--
(I) 1 or more patients is
enrolled in the clinical trial;
and
(II) the date is before the
completion date of the clinical
trial.
(ix) Responsible party.--The term
``responsible party'', with respect to
a clinical trial of a drug or device,
means--
(I) the sponsor of the
clinical trial (as defined in
section 50.3 of title 21, Code
of Federal Regulations (or any
successor regulation)); or
(II) the principal
investigator of such clinical
trial if so designated by a
sponsor, grantee, contractor,
or awardee, so long as the
principal investigator is
responsible for conducting the
trial, has access to and
control over the data from the
clinical trial, has the right
to publish the results of the
trial, and has the ability to
meet all of the requirements
under this subsection for the
submission of clinical trial
information.
(B) Requirement.--The Secretary shall
develop a mechanism by which the responsible
party for each applicable clinical trial shall
submit the identity and contact information of
such responsible party to the Secretary at the
time of submission of clinical trial
information under paragraph (2).
(2) Expansion of clinical trial registry data bank
with respect to clinical trial information.--
(A) In general.--
(i) Expansion of data bank.--To
enhance patient enrollment and provide
a mechanism to track subsequent
progress of clinical trials, the
Secretary, acting through the Director
of NIH, shall expand, in accordance
with this subsection, the clinical
trials registry of the data bank
described under subsection (i)(1)
(referred to in this subsection as the
``registry data bank''). The Director
of NIH shall ensure that the registry
data bank is made publicly available
through the Internet.
(ii) Content.--The clinical trial
information required to be submitted
under this paragraph for an applicable
clinical trial shall include--
(I) descriptive
information, including--
(aa) a brief title,
intended for the lay
public;
(bb) a brief
summary, intended for
the lay public;
(cc) the primary
purpose;
(dd) the study
design;
(ee) for an
applicable drug
clinical trial, the
study phase;
(ff) study type;
(gg) the primary
disease or condition
being studied, or the
focus of the study;
(hh) the
intervention name and
intervention type;
(ii) the study
start date;
(jj) the expected
completion date;
(kk) the target
number of subjects; and
(ll) outcomes,
including primary and
secondary outcome
measures;
(II) recruitment
information, including--
(aa) eligibility
criteria;
(bb) gender;
(cc) age limits;
(dd) whether the
trial accepts healthy
volunteers;
(ee) overall
recruitment status;
(ff) individual
site status; and
(gg) in the case of
an applicable drug
clinical trial, if the
drug is not approved
under section 505 of
the Federal Food, Drug,
and Cosmetic Act or
licensed under section
351 of this Act,
specify whether or not
there is expanded
access to the drug
under section 561 of
the Federal Food, Drug,
and Cosmetic Act for
those who do not
qualify for enrollment
in the clinical trial
and how to obtain
information about such
access;
(III) location and contact
information, including--
(aa) the name of
the sponsor;
(bb) the
responsible party, by
official title; and
(cc) the facility
name and facility
contact information
(including the city,
State, and zip code for
each clinical trial
location, or a toll-
free number through
which such location
information may be
accessed); and
(IV) administrative data
(which the Secretary may make
publicly available as
necessary), including--
(aa) the unique
protocol identification
number;
(bb) other protocol
identification numbers,
if any; and
(cc) the Food and
Drug Administration
IND/IDE protocol number
and the record
verification date.
(iii) Modifications.--The Secretary
may by regulation modify the
requirements for clinical trial
information under this paragraph, if
the Secretary provides a rationale for
why such a modification improves and
does not reduce such clinical trial
information.
(B) Format and structure.--
(i) Searchable categories.--The
Director of NIH shall ensure that the
public may, in addition to keyword
searching, search the entries in the
registry data bank by 1 or more of the
following criteria:
(I) The disease or
condition being studied in the
clinical trial, using Medical
Subject Headers (MeSH)
descriptors.
(II) The name of the
intervention, including any
drug or device being studied in
the clinical trial.
(III) The location of the
clinical trial.
(IV) The age group studied
in the clinical trial,
including pediatric
subpopulations.
(V) The study phase of the
clinical trial.
(VI) The sponsor of the
clinical trial, which may be
the National Institutes of
Health or another Federal
agency, a private industry
source, or a university or
other organization.
(VII) The recruitment
status of the clinical trial.
(VIII) The National
Clinical Trial number or other
study identification for the
clinical trial.
(ii) Additional searchable
category.--Not later than 18 months
after the date of the enactment of the
Food and Drug Administration Amendments
Act of 2007, the Director of NIH shall
ensure that the public may search the
entries of the registry data bank by
the safety issue, if any, being studied
in the clinical trial as a primary or
secondary outcome.
(iii) Other elements.--The Director
of NIH shall also ensure that the
public may search the entries of the
registry data bank by such other
elements as the Director deems
necessary on an ongoing basis.
(iv) Format.--The Director of the
NIH shall ensure that the registry data
bank is easily used by the public, and
that entries are easily compared.
(C) Data submission.--The responsible party
for an applicable clinical trial, including an
applicable drug clinical trial for a serious or
life-threatening disease or condition, that is
initiated after, or is ongoing on the date that
is 90 days after, the date of the enactment of
the Food and Drug Administration Amendments Act
of 2007, shall submit to the Director of NIH
for inclusion in the registry data bank the
clinical trial information described in of
subparagraph (A)(ii) not later than the later
of--
(i) 90 days after such date of
enactment;
(ii) 21 days after the first
patient is enrolled in such clinical
trial; or
(iii) in the case of a clinical
trial that is not for a serious or
life-threatening disease or condition
and that is ongoing on such date of
enactment, 1 year after such date of
enactment.
(D) Posting of data.--
(i) Applicable drug clinical
trial.--The Director of NIH shall
ensure that clinical trial information
for an applicable drug clinical trial
submitted in accordance with this
paragraph is posted in the registry
data bank not later than 30 days after
such submission.
(ii) Applicable device clinical
trial.--The Director of NIH shall
ensure that clinical trial information
for an applicable device clinical trial
submitted in accordance with this
paragraph is posted publicly in the
registry data bank--
(I) not earlier than the
date of clearance under section
510(k) of the Federal Food,
Drug, and Cosmetic Act, or
approval under section 515 or
520(m) of such Act, as
applicable, for a device that
was not previously cleared or
approved, and not later than 30
days after such date; or
(II) for a device that was
previously cleared or approved,
not later than 30 days after
the clinical trial information
under paragraph (3)(C) is
required to be posted by the
Secretary.
(3) Expansion of registry data bank to include
results of clinical trials.--
(A) Linking registry data bank to existing
results.--
(i) In general.--Beginning not
later than 90 days after the date of
the enactment of the Food and Drug
Administration Amendments Act of 2007,
for those clinical trials that form the
primary basis of an efficacy claim or
are conducted after the drug involved
is approved or after the device
involved is cleared or approved, the
Secretary shall ensure that the
registry data bank includes links to
results information as described in
clause (ii) for such clinical trial--
(I) not earlier than 30
days after the date of the
approval of the drug involved
or clearance or approval of the
device involved; or
(II) not later than 30 days
after the results information
described in clause (ii)
becomes publicly available.
(ii) Required information.--
(I) FDA information.--The
Secretary shall ensure that the
registry data bank includes
links to the following
information:
(aa) If an advisory
committee considered at
a meeting an applicable
clinical trial, any
posted Food and Drug
Administration summary
document regarding such
applicable clinical
trial.
(bb) If an
applicable drug
clinical trial was
conducted under section
505A or 505B of the
Federal Food, Drug, and
Cosmetic Act, a link to
the posted Food and
Drug Administration
assessment of the
results of such trial.
(cc) Food and Drug
Administration public
health advisories
regarding the drug or
device that is the
subject of the
applicable clinical
trial, if any.
(dd) For an
applicable drug
clinical trial, the
Food and Drug
Administration action
package for approval
document required under
section 505(l)(2) of
the Federal Food, Drug,
and Cosmetic Act.
(ee) For an
applicable device
clinical trial, in the
case of a premarket
application under
section 515 of the
Federal Food, Drug, and
Cosmetic Act, the
detailed summary of
information respecting
the safety and
effectiveness of the
device required under
section 520(h)(1) of
such Act, or, in the
case of a report under
section 510(k) of such
Act, the section 510(k)
summary of the safety
and effectiveness data
required under section
807.95(d) of title 21,
Code of Federal
Regulations (or any
successor regulation).
(II) NIH information.--The
Secretary shall ensure that the
registry data bank includes
links to the following
information:
(aa) Medline
citations to any
publications focused on
the results of an
applicable clinical
trial.
(bb) The entry for
the drug that is the
subject of an
applicable drug
clinical trial in the
National Library of
Medicine database of
structured product
labels, if available.
(iii) Results for existing data
bank entries.--The Secretary may
include the links described in clause
(ii) for data bank entries for clinical
trials submitted to the data bank prior
to enactment of the Food and Drug
Administration Amendments Act of 2007,
as available.
(B) Inclusion of results.--The Secretary,
acting through the Director of NIH, shall--
(i) expand the registry data bank
to include the results of applicable
clinical trials (referred to in this
subsection as the ``registry and
results data bank'');
(ii) ensure that such results are
made publicly available through the
Internet;
(iii) post publicly a glossary for
the lay public explaining technical
terms related to the results of
clinical trials; and
(iv) in consultation with experts
on risk communication, provide
information with the information
included under subparagraph (C) in the
registry and results data bank to help
ensure that such information does not
mislead the patients or the public.
(C) Basic results.--Not later than 1 year
after the date of the enactment of the Food and
Drug Administration Amendments Act of 2007, the
Secretary shall include in the registry and
results data bank for each applicable clinical
trial for a drug that is approved under section
505 of the Federal Food, Drug, and Cosmetic Act
or licensed under section 351 of this Act or a
device that is cleared under section 510(k) of
the Federal Food, Drug, and Cosmetic Act or
approved under section 515 or 520(m) of such
Act, the following elements:
(i) Demographic and baseline
characteristics of patient sample.--A
table of the demographic and baseline
data collected overall and for each arm
of the clinical trial to describe the
patients who participated in the
clinical trial, including the number of
patients who dropped out of the
clinical trial and the number of
patients excluded from the analysis, if
any.
(ii) Primary and secondary
outcomes.--The primary and secondary
outcome measures as submitted under
paragraph (2)(A)(ii)(I)(ll), and a
table of values for each of the primary
and secondary outcome measures for each
arm of the clinical trial, including
the results of scientifically
appropriate tests of the statistical
significance of such outcome measures.
(iii) Point of contact.--A point of
contact for scientific information
about the clinical trial results.
(iv) Certain agreements.--Whether
there exists an agreement (other than
an agreement solely to comply with
applicable provisions of law protecting
the privacy of participants) between
the sponsor or its agent and the
principal investigator (unless the
sponsor is an employer of the principal
investigator) that restricts in any
manner the ability of the principal
investigator, after the completion date
of the trial, to discuss the results of
the trial at a scientific meeting or
any other public or private forum, or
to publish in a scientific or academic
journal information concerning the
results of the trial.
(D) Expanded registry and results data
bank.--
(i) Expansion by rulemaking.--To
provide more complete results
information and to enhance patient
access to and understanding of the
results of clinical trials, not later
than 3 years after the date of the
enactment of the Food and Drug
Administration Amendments Act of 2007,
the Secretary shall by regulation
expand the registry and results data
bank as provided under this
subparagraph.
(ii) Clinical trials.--
(I) Approved products.--The
regulations under this
subparagraph shall require the
inclusion of the results
information described in clause
(iii) for--
(aa) each
applicable drug
clinical trial for a
drug that is approved
under section 505 of
the Federal Food, Drug,
and Cosmetic Act or
licensed under section
351 of this Act; and
(bb) each
applicable device
clinical trial for a
device that is cleared
under section 510(k) of
the Federal Food, Drug,
and Cosmetic Act or
approved under section
515 or 520(m) of such
Act.
(II) Unapproved products.--
The regulations under this
subparagraph shall establish
whether or not the results
information described in clause
(iii) shall be required for--
(aa) an applicable
drug clinical trial for
a drug that is not
approved under section
505 of the Federal
Food, Drug, and
Cosmetic Act and not
licensed under section
351 of this Act
(whether approval or
licensure was sought or
not); and
(bb) an applicable
device clinical trial
for a device that is
not cleared under
section 510(k) of the
Federal Food, Drug, and
Cosmetic Act and not
approved under section
515 or section 520(m)
of such Act (whether
clearance or approval
was sought or not).
(iii) Required elements.--The
regulations under this subparagraph
shall require, in addition to the
elements described in subparagraph (C),
information within each of the
following categories:
(I) A summary of the
clinical trial and its results
that is written in non-
technical, understandable
language for patients, if the
Secretary determines that such
types of summary can be
included without being
misleading or promotional.
(II) A summary of the
clinical trial and its results
that is technical in nature, if
the Secretary determines that
such types of summary can be
included without being
misleading or promotional.
(III) The full protocol or
such information on the
protocol for the trial as may
be necessary to help to
evaluate the results of the
trial.
(IV) Such other categories
as the Secretary determines
appropriate.
(iv) Results submission.--The
results information described in clause
(iii) shall be submitted to the
Director of NIH for inclusion in the
registry and results data bank as
provided by subparagraph (E), except
that the Secretary shall by regulation
determine--
(I) whether the 1-year
period for submission of
clinical trial information
described in subparagraph
(E)(i) should be increased from
1 year to a period not to
exceed 18 months;
(II) whether the clinical
trial information described in
clause (iii) should be required
to be submitted for an
applicable clinical trial for
which the clinical trial
information described in
subparagraph (C) is submitted
to the registry and results
data bank before the effective
date of the regulations issued
under this subparagraph; and
(III) in the case when the
clinical trial information
described in clause (iii) is
required to be submitted for
the applicable clinical trials
described in clause (ii)(II),
the date by which such clinical
trial information shall be
required to be submitted,
taking into account--
(aa) the
certification process
under subparagraph
(E)(iii) when approval,
licensure, or clearance
is sought; and
(bb) whether there
should be a delay of
submission when
approval, licensure, or
clearance will not be
sought.
(v) Additional provisions.--The
regulations under this subparagraph
shall also establish--
(I) a standard format for
the submission of clinical
trial information under this
paragraph to the registry and
results data bank;
(II) additional information
on clinical trials and results
that is written in
nontechnical, understandable
language for patients;
(III) considering the
experience under the pilot
quality control project
described in paragraph (5)(C),
procedures for quality control,
including using representative
samples, with respect to
completeness and content of
clinical trial information
under this subsection, to help
ensure that data elements are
not false or misleading and are
non-promotional;
(IV) the appropriate timing
and requirements for updates of
clinical trial information, and
whether and, if so, how such
updates should be tracked;
(V) a statement to
accompany the entry for an
applicable clinical trial when
the primary and secondary
outcome measures for such
clinical trial are submitted
under paragraph (4)(A) after
the date specified for the
submission of such information
in paragraph (2)(C); and
(VI) additions or
modifications to the manner of
reporting of the data elements
established under subparagraph
(C).
(vi) Consideration of world health
organization data set.--The Secretary
shall consider the status of the
consensus data elements set for
reporting clinical trial results of the
World Health Organization when issuing
the regulations under this
subparagraph.
(vii) Public meeting.--The
Secretary shall hold a public meeting
no later than 18 months after the date
of the enactment of the Food and Drug
Administration Amendments Act of 2007
to provide an opportunity for input
from interested parties with regard to
the regulations to be issued under this
subparagraph.
(E) Submission of results information.--
(i) In general.--Except as provided
in clauses (iii), (iv), (v), and (vi)
the responsible party for an applicable
clinical trial that is described in
clause (ii) shall submit to the
Director of NIH for inclusion in the
registry and results data bank the
clinical trial information described in
subparagraph (C) not later than 1 year,
or such other period as may be provided
by regulation under subparagraph (D),
after the earlier of--
(I) the estimated
completion date of the trial as
described in paragraph
(2)(A)(ii)(I)(jj)); or
(II) the actual date of
completion.
(ii) Clinical trials described.--An
applicable clinical trial described in
this clause is an applicable clinical
trial subject to--
(I) paragraph (2)(C); and
(II)(aa) subparagraph (C);
or
(bb) the regulations issued
under subparagraph (D).
(iii) Delayed submission of results
with certification.--If the responsible
party for an applicable clinical trial
submits a certification that clause
(iv) or (v) applies to such clinical
trial, the responsible party shall
submit to the Director of NIH for
inclusion in the registry and results
data bank the clinical trial
information described in subparagraphs
(C) and (D) as required under the
applicable clause.
(iv) Seeking initial approval of a
drug or device.--With respect to an
applicable clinical trial that is
completed before the drug is initially
approved under section 505 of the
Federal Food, Drug, and Cosmetic Act or
initially licensed under section 351 of
this Act, or the device is initially
cleared under section 510(k) or
initially approved under section 515 or
520(m) of the Federal Food, Drug, and
Cosmetic Act, the responsible party
shall submit to the Director of NIH for
inclusion in the registry and results
data bank the clinical trial
information described in subparagraphs
(C) and (D) not later than 30 days
after the drug or device is approved
under such section 505, licensed under
such section 351, cleared under such
section 510(k), or approved under such
section 515 or 520(m), as applicable.
(v) Seeking approval of a new use
for the drug or device.--
(I) In general.--With
respect to an applicable
clinical trial where the
manufacturer of the drug or
device is the sponsor of an
applicable clinical trial, and
such manufacturer has filed, or
will file within 1 year, an
application seeking approval
under section 505 of the
Federal Food, Drug, and
Cosmetic Act, licensing under
section 351 of this Act, or
clearance under section 510(k),
or approval under section 515
or 520(m), of the Federal Food,
Drug, and Cosmetic Act for the
use studied in such clinical
trial (which use is not
included in the labeling of the
approved drug or device), then
the responsible party shall
submit to the Director of NIH
for inclusion in the registry
and results data bank the
clinical trial information
described in subparagraphs (C)
and (D) on the earlier of the
date that is 30 days after the
date--
(aa) the new use of
the drug or device is
approved under such
section 505, licensed
under such section 351,
cleared under such
section 510(k), or
approved under such
section 515 or 520(m);
(bb) the Secretary
issues a letter, such
as a complete response
letter, not approving
the submission or not
clearing the
submission, a not
approvable letter, or a
not substantially
equivalent letter for
the new use of the drug
or device under such
section 505, 351,
510(k), 515, or 520(m);
or
(cc) except as
provided in subclause
(III), the application
or premarket
notification under such
section 505, 351,
510(k), 515, or 520(m)
is withdrawn without
resubmission for no
less than 210 days.
(II) Requirement that each
clinical trial in application
be treated the same.--If a
manufacturer makes a
certification under clause
(iii) that this clause applies
with respect to a clinical
trial, the manufacturer shall
make such a certification with
respect to each applicable
clinical trial that is required
to be submitted in an
application or report for
licensure, approval, or
clearance (under section 351 of
this Act or section 505,
510(k), 515, or 520(m) of the
Federal Food, Drug, and
Cosmetic Act, as applicable) of
the use studied in the clinical
trial.
(III) Two-year
limitation.--The responsible
party shall submit to the
Director of NIH for inclusion
in the registry and results
data bank the clinical trial
information subject to
subclause (I) on the date that
is 2 years after the date a
certification under clause
(iii) was made to the Director
of NIH, if an action referred
to in item (aa), (bb), or (cc)
of subclause (I) has not
occurred by such date.
(vi) Extensions.--The Director of
NIH may provide an extension of the
deadline for submission of clinical
trial information under clause (i) if
the responsible party for the trial
submits to the Director a written
request that demonstrates good cause
for the extension and provides an
estimate of the date on which the
information will be submitted. The
Director of NIH may grant more than one
such extension for a clinical trial.
(F) Notice to director of nih.--The
Commissioner of Food and Drugs shall notify the
Director of NIH when there is an action
described in subparagraph (E)(iv) or item (aa),
(bb), or (cc) of subparagraph (E)(v)(I) with
respect to an application or a report that
includes a certification required under
paragraph (5)(B) of such action not later than
30 days after such action.
(G) Posting of data.--The Director of NIH
shall ensure that the clinical trial
information described in subparagraphs (C) and
(D) for an applicable clinical trial submitted
in accordance with this paragraph is posted
publicly in the registry and results database
not later than 30 days after such submission.
(H) Waivers regarding certain clinical
trial results.--The Secretary may waive any
applicable requirements of this paragraph for
an applicable clinical trial, upon a written
request from the responsible party, if the
Secretary determines that extraordinary
circumstances justify the waiver and that
providing the waiver is consistent with the
protection of public health, or in the interest
of national security. Not later than 30 days
after any part of a waiver is granted, the
Secretary shall notify, in writing, the
appropriate committees of Congress of the
waiver and provide an explanation for why the
waiver was granted.
(I) Adverse events.--
(i) Regulations.--Not later than 18
months after the date of the enactment
of the Food and Drug Administration
Amendments Act of 2007, the Secretary
shall by regulation determine the best
method for including in the registry
and results data bank appropriate
results information on serious adverse
and frequent adverse events for
applicable clinical trials described in
subparagraph (C) in a manner and form
that is useful and not misleading to
patients, physicians, and scientists.
(ii) Default.--If the Secretary
fails to issue the regulation required
by clause (i) by the date that is 24
months after the date of the enactment
of the Food and Drug Administration
Amendments Act of 2007, clause (iii)
shall take effect.
(iii) Additional elements.--Upon
the application of clause (ii), the
Secretary shall include in the registry
and results data bank for applicable
clinical trials described in
subparagraph (C), in addition to the
clinical trial information described in
subparagraph (C), the following
elements:
(I) Serious adverse
events.--A table of anticipated
and unanticipated serious
adverse events grouped by organ
system, with number and
frequency of such event in each
arm of the clinical trial.
(II) Frequent adverse
events.--A table of anticipated
and unanticipated adverse
events that are not included in
the table described in
subclause (I) that exceed a
frequency of 5 percent within
any arm of the clinical trial,
grouped by organ system, with
number and frequency of such
event in each arm of the
clinical trial.
(iv) Posting of other
information.--In carrying out clause
(iii), the Secretary shall, in
consultation with experts in risk
communication, post with the tables
information to enhance patient
understanding and to ensure such tables
do not mislead patients or the lay
public.
(v) Relation to subparagraph (c).--
Clinical trial information included in
the registry and results data bank
pursuant to this subparagraph is deemed
to be clinical trial information
included in such data bank pursuant to
subparagraph (C).
(4) Additional submissions of clinical trial
information.--
(A) Voluntary submissions.--A responsible
party for a clinical trial that is not an
applicable clinical trial, or that is an
applicable clinical trial that is not subject
to paragraph (2)(C), may submit complete
clinical trial information described in
paragraph (2) or paragraph (3) provided the
responsible party submits clinical trial
information for each applicable clinical trial
that is required to be submitted under section
351 or under section 505, 510(k), 515, or
520(m) of the Federal Food, Drug, and Cosmetic
Act in an application or report for licensure,
approval, or clearance of the drug or device
for the use studied in the clinical trial.
(B) Required submissions.--
(i) In general.--Notwithstanding
paragraphs (2) and (3) and subparagraph
(A), in any case in which the Secretary
determines for a specific clinical
trial described in clause (ii) that
posting in the registry and results
data bank of clinical trial information
for such clinical trial is necessary to
protect the public health--
(I) the Secretary may
require by notification that
such information be submitted
to the Secretary in accordance
with paragraphs (2) and (3)
except with regard to timing of
submission;
(II) unless the responsible
party submits a certification
under paragraph (3)(E)(iii),
such information shall be
submitted not later than 30
days after the date specified
by the Secretary in the
notification; and
(III) failure to comply
with the requirements under
subclauses (I) and (II) shall
be treated as a violation of
the corresponding requirement
of such paragraphs.
(ii) Clinical trials described.--A
clinical trial described in this clause
is--
(I) an applicable clinical
trial for a drug that is
approved under section 505 of
the Federal Food, Drug, and
Cosmetic Act or licensed under
section 351 of this Act or for
a device that is cleared under
section 510(k) of the Federal
Food, Drug, and Cosmetic Act or
approved under section 515 or
section 520(m) of such Act,
whose completion date is on or
after the date 10 years before
the date of the enactment of
the Food and Drug
Administration Amendments Act
of 2007; or
(II) an applicable clinical
trial that is described by both
by paragraph (2)(C) and
paragraph (3)(D)(ii)(II)).
(C) Updates to clinical trial data bank.--
(i) Submission of updates.--The
responsible party for an applicable
clinical trial shall submit to the
Director of NIH for inclusion in the
registry and results data bank updates
to reflect changes to the clinical
trial information submitted under
paragraph (2). Such updates--
(I) shall be provided not
less than once every 12 months,
unless there were no changes to
the clinical trial information
during the preceding 12-month
period;
(II) shall include
identification of the dates of
any such changes;
(III) not later than 30
days after the recruitment
status of such clinical trial
changes, shall include an
update of the recruitment
status; and
(IV) not later than 30 days
after the completion date of
the clinical trial, shall
include notification to the
Director that such clinical
trial is complete.
(ii) Public availability of
updates.--The Director of NIH shall
make updates submitted under clause (i)
publicly available in the registry data
bank. Except with regard to overall
recruitment status, individual site
status, location, and contact
information, the Director of NIH shall
ensure that updates to elements
required under subclauses (I) to (V) of
paragraph (2)(A)(ii) do not result in
the removal of any information from the
original submissions or any preceding
updates, and information in such
databases is presented in a manner that
enables users to readily access each
original element submission and to
track the changes made by the updates.
The Director of NIH shall provide a
link from the table of primary and
secondary outcomes required under
paragraph (3)(C)(ii) to the tracked
history required under this clause of
the primary and secondary outcome
measures submitted under paragraph
(2)(A)(ii)(I)(ll).
(5) Coordination and compliance.--
(A) Clinical trials supported by grants
from federal agencies.--
(i) Grants from certain federal
agencies.--If an applicable clinical
trial is funded in whole or in part by
a grant from any agency of the
Department of Health and Human
Services, including the Food and Drug
Administration, the National Institutes
of Health, or the Agency for Healthcare
Research and Quality, any grant or
progress report forms required under
such grant shall include a
certification that the responsible
party has made all required submissions
to the Director of NIH under paragraphs
(2) and (3).
(ii) Verification by federal
agencies.--The heads of the agencies
referred to in clause (i), as
applicable, shall verify that the
clinical trial information for each
applicable clinical trial for which a
grantee is the responsible party has
been submitted under paragraphs (2) and
(3) before releasing any remaining
funding for a grant or funding for a
future grant to such grantee.
(iii) Notice and opportunity to
remedy.--If the head of an agency
referred to in clause (i), as
applicable, verifies that a grantee has
not submitted clinical trial
information as described in clause
(ii), such agency head shall provide
notice to such grantee of such non-
compliance and allow such grantee 30
days to correct such non-compliance and
submit the required clinical trial
information.
(iv) Consultation with other
federal agencies.--The Secretary
shall--
(I) consult with other
agencies that conduct research
involving human subjects in
accordance with any section of
part 46 of title 45, Code of
Federal Regulations (or any
successor regulations), to
determine if any such research
is an applicable clinical
trial; and
(II) develop with such
agencies procedures comparable
to those described in clauses
(i), (ii), and (iii) to ensure
that clinical trial information
for such applicable clinical
trial is submitted under
paragraphs (2) and (3).
(B) Certification to accompany drug,
biological product, and device submissions.--At
the time of submission of an application under
section 505 of the Federal Food, Drug, and
Cosmetic Act, section 515 of such Act, section
520(m) of such Act, or section 351 of this Act,
or submission of a report under section 510(k)
of such Act, such application or submission
shall be accompanied by a certification that
all applicable requirements of this subsection
have been met. Where available, such
certification shall include the appropriate
National Clinical Trial control numbers.
(C) Quality control.--
(i) Pilot quality control
project.--Until the effective date of
the regulations issued under paragraph
(3)(D), the Secretary, acting through
the Director of NIH and the
Commissioner of Food and Drugs, shall
conduct a pilot project to determine
the optimal method of verification to
help to ensure that the clinical trial
information submitted under paragraph
(3)(C) is non-promotional and is not
false or misleading in any particular
under subparagraph (D). The Secretary
shall use the publicly available
information described in paragraph
(3)(A) and any other information
available to the Secretary about
applicable clinical trials to verify
the accuracy of the clinical trial
information submitted under paragraph
(3)(C).
(ii) Notice of compliance.--If the
Secretary determines that any clinical
trial information was not submitted as
required under this subsection, or was
submitted but is false or misleading in
any particular, the Secretary shall
notify the responsible party and give
such party an opportunity to remedy
such noncompliance by submitting the
required revised clinical trial
information not later than 30 days
after such notification.
(D) Truthful clinical trial information.--
(i) In general.--The clinical trial
information submitted by a responsible
party under this subsection shall not
be false or misleading in any
particular.
(ii) Effect.--Clause (i) shall not
have the effect of--
(I) requiring clinical
trial information with respect
to an applicable clinical trial
to include information from any
source other than such clinical
trial involved; or
(II) requiring clinical
trial information described in
paragraph (3)(D) to be
submitted for purposes of
paragraph (3)(C).
(E) Public notices.--
(i) Notice of violations.--If the
responsible party for an applicable
clinical trial fails to submit clinical
trial information for such clinical
trial as required under paragraphs (2)
or (3), the Director of NIH shall
include in the registry and results
data bank entry for such clinical trial
a notice--
(I) that the responsible
party is not in compliance with
this Act by--
(aa) failing to
submit required
clinical trial
information; or
(bb) submitting
false or misleading
clinical trial
information;
(II) of the penalties
imposed for the violation, if
any; and
(III) whether the
responsible party has corrected
the clinical trial information
in the registry and results
data bank.
(ii) Notice of failure to submit
primary and secondary outcomes.--If the
responsible party for an applicable
clinical trial fails to submit the
primary and secondary outcomes as
required under section 2(A)(ii)(I)(ll),
the Director of NIH shall include in
the registry and results data bank
entry for such clinical trial a notice
that the responsible party is not in
compliance by failing to register the
primary and secondary outcomes in
accordance with this act, and that the
primary and secondary outcomes were not
publicly disclosed in the database
before conducting the clinical trial.
(iii) Failure to submit
statement.--The notice under clause (i)
for a violation described in clause
(i)(I)(aa) shall include the following
statement: ``The entry for this
clinical trial was not complete at the
time of submission, as required by law.
This may or may not have any bearing on
the accuracy of the information in the
entry.''.
(iv) Submission of false
information statement.--The notice
under clause (i) for a violation
described in clause (i)(I)(bb) shall
include the following statement: ``The
entry for this clinical trial was found
to be false or misleading and therefore
not in compliance with the law.''.
(v) Non-submission of statement.--
The notice under clause (ii) for a
violation described in clause (ii)
shall include the following statement:
``The entry for this clinical trial did
not contain information on the primary
and secondary outcomes at the time of
submission, as required by law. This
may or may not have any bearing on the
accuracy of the information in the
entry.''.
(vi) Compliance searches.--The
Director of NIH shall provide that the
public may easily search the registry
and results data bank for entries that
include notices required under this
subparagraph.
(6) Limitation on disclosure of clinical trial
information.--
(A) In general.--Nothing in this subsection
(or under section 552 of title 5, United States
Code) shall require the Secretary to publicly
disclose, by any means other than the registry
and results data bank, information described in
subparagraph (B).
(B) Information described.--Information
described in this subparagraph is--
(i) information submitted to the
Director of NIH under this subsection,
or information of the same general
nature as (or integrally associated
with) the information so submitted; and
(ii) information not otherwise
publicly available, including because
it is protected from disclosure under
section 552 of title 5, United States
Code.
(7) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection $10,000,000 for each fiscal year.
(k)(1) The Director of NIH may establish a program to
provide day care services for the employees of the National
Institutes of Health similar to those services provided by
other Federal agencies (including the availability of day care
service on a 24-hour-a-day basis).
(2) Any day care provider at the National Institutes of
Health shall establish a sliding scale of fees that takes into
consideration the income and needs of the employee.
(3) For purposes regarding the provision of day care
services, the Director of NIH may enter into rental or lease
purchase agreements.
(l) Council of Councils.--
(1) Establishment.--Not later than 90 days after
the date of the enactment of the National Institutes of
Health Reform Act of 2006, the Director of NIH shall
establish within the Office of the Director an advisory
council to be known as the ``Council of Councils''
(referred to in this subsection as the ``Council'') for
the purpose of advising the Director on matters related
to the policies and activities of the Division of
Program Coordination, Planning, and Strategic
Initiatives, including making recommendations with
respect to the conduct and support of research
described in subsection (b)(7).
(2) Membership.--
(A) In general.--The Council shall be
composed of 27 members selected by the Director
of NIH with approval from the Secretary from
among the list of nominees under subparagraph
(C).
(B) Certain requirements.--In selecting the
members of the Council, the Director of NIH
shall ensure--
(i) the representation of a broad
range of disciplines and perspectives;
and
(ii) the ongoing inclusion of at
least 1 representative from each
national research institute whose
budget is substantial relative to a
majority of the other institutes.
(C) Nomination.--The Director of NIH shall
maintain an updated list of individuals who
have been nominated to serve on the Council,
which list shall consist of the following:
(i) For each national research
institute and national center, 3
individuals nominated by the head of
such institute or center from among the
members of the advisory council of the
institute or center, of which--
(I) two shall be
scientists; and
(II) one shall be from the
general public or shall be a
leader in the field of public
policy, law, health policy,
economics, or management.
(ii) For each office within the
Division of Program Coordination,
Planning, and Strategic Initiatives, 1
individual nominated by the head of
such office.
(iii) Members of the Council of
Public Representatives.
(3) Terms.--
(A) In general.--The term of service for a
member of the Council shall be 6 years, except
as provided in subparagraphs (B) and (C).
(B) Terms of initial appointees.--Of the
initial members selected for the Council, the
Director of NIH shall designate--
(i) nine for a term of 6 years;
(ii) nine for a term of 4 years;
and
(iii) nine for a term of 2 years.
(C) Vacancies.--Any member appointed to
fill a vacancy occurring before the expiration
of the term for which the member's predecessor
was appointed shall be appointed only for the
remainder of that term. A member may serve
after the expiration of that member's term
until a successor has taken office.
SEC. 402A. [282A] AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out this
title, there are authorized to be appropriated--
(1) $30,331,309,000 for fiscal year 2007;
(2) $32,831,309,000 for fiscal year 2008; and
(3) such sums as may be necessary for fiscal year
2009.
(b) Office of the Director.--Of the amount authorized to be
appropriated under subsection (a) for a fiscal year, there are
authorized to be appropriated for programs and activities under
this title carried out through the Office of the Director of
NIH such sums as may be necessary for each of the fiscal years
2007 through 2009.
(c) Trans-NIH Research.--
(1) Common fund.--
(A) Account.--For the purpose of
allocations under section 402(b)(7)(B)
(relating to research identified by the
Division of Program Coordination, Planning, and
Strategic Initiatives), there is established an
account to be known as the Common Fund.
(B) Reservation.--
(i) In general.--Of the total
amount appropriated under subsection
(a) for fiscal year 2007 or any
subsequent fiscal year, the Director of
NIH shall reserve an amount for the
Common Fund, subject to any applicable
provisions in appropriations Acts.
(ii) Minimum amount.--For each
fiscal year, the percentage constituted
by the amount reserved under clause (i)
relative to the total amount
appropriated under subsection (a) for
such year may not be less than the
percentage constituted by the amount so
reserved for the preceding fiscal year
relative to the total amount
appropriated under subsection (a) for
such preceding fiscal year, subject to
any applicable provisions in
appropriations Acts.
(C) Common fund strategic planning
report.--Not later than June 1, 2007, and every
2 years thereafter, the Secretary, acting
through the Director of NIH, shall submit a
report to the Congress containing a strategic
plan for funding research described in section
402(b)(7)(A)(i) (including personnel needs)
through the Common Fund. Each such plan shall
include the following:
(i) An estimate of the amounts
determined by the Director of NIH to be
appropriate for maximizing the
potential of such research.
(ii) An estimate of the amounts
determined by the Director of NIH to be
sufficient only for continuing to fund
research activities previously
identified by the Division of Program
Coordination, Planning, and Strategic
Initiatives.
(iii) An estimate of the amounts
determined by the Director of NIH to be
necessary to fund research described in
section 402(b)(7)(A)(i)--
(I) that is in addition to
the research activities
described in clause (ii); and
(II) for which there is the
most substantial need.
(D) Evaluation.--During the 6-month period
following the end of the first fiscal year for
which the total amount reserved under
subparagraph (B) is equal to 5 percent of the
total amount appropriated under subsection (a)
for such fiscal year, the Secretary, acting
through the Director of NIH, in consultation
with the advisory council established under
section 402(k), shall submit recommendations to
the Congress for changes regarding amounts for
the Common Fund.
(2) Trans-nih research reporting.--
(A) Limitation.--With respect to the total
amount appropriated under subsection (a) for
fiscal year 2008 or any subsequent fiscal year,
if the head of a national research institute or
national center fails to submit the report
required by subparagraph (B) for the preceding
fiscal year, the amount made available for the
institute or center for the fiscal year
involved may not exceed the amount made
available for the institute or center for
fiscal year 2006.
(B) Reporting.--Not later than January 1,
2008, and each January 1st thereafter--
(i) the head of each national
research institute or national center
shall submit to the Director of NIH a
report on the amount made available by
the institute or center for conducting
or supporting research that involves
collaboration between the institute or
center and 1 or more other national
research institutes or national
centers; and
(ii) the Secretary shall submit a
report to the Congress identifying the
percentage of funds made available by
each national research institute and
national center with respect to such
fiscal year for conducting or
supporting research described in clause
(i).
(C) Determination.--For purposes of
determining the amount or percentage of funds
to be reported under subparagraph (B), any
amounts made available to an institute or
center under section 402(b)(7)(B) shall be
included.
(D) Verification of amounts.--Upon receipt
of each report submitted under subparagraph
(B)(i), the Director of NIH shall review and,
in cases of discrepancy, verify the accuracy of
the amounts specified in the report.
(E) Waiver.--At the request of any national
research institute or national center, the
Director of NIH may waive the application of
this paragraph to such institute or center if
the Director finds that the conduct or support
of research described in subparagraph (B)(i) is
inconsistent with the mission of such institute
or center.
(d) Transfer Authority.--Of the total amount appropriated
under subsection (a) for a fiscal year, the Director of NIH may
(in addition to the reservation under subsection (c)(1) for
such year) transfer not more than 1 percent for programs or
activities that are authorized in this title and identified by
the Director to receive funds pursuant to this subsection. In
making such transfers, the Director may not decrease any
appropriation account under subsection (a) by more than 1
percent.
(e) Rule of Construction.--This section may not be
construed as affecting the authorities of the Director of NIH
under section 401.
SEC. 402B. [282B] ELECTRONIC CODING OF GRANTS AND ACTIVITIES.
The Secretary, acting through the Director of NIH, shall
establish an electronic system to uniformly code research
grants and activities of the Office of the Director and of all
the national research institutes and national centers. The
electronic system shall be searchable by a variety of codes,
such as the type of research grant, the research entity
managing the grant, and the public health area of interest.
When permissible, the Secretary, acting through the Director of
NIH, shall provide information on relevant literature and
patents that are associated with research activities of the
National Institutes of Health.
SEC. 402C. [282D] CURES ACCELERATION NETWORK.
(a) Definitions.--In this section:
(1) Biological product.--The term ``biological
product'' has the meaning given such term in section
351 of the Public Health Service Act.
(2) Drug; device.--The terms ``drug'' and
``device'' have the meanings given such terms in
section 201 of the Federal Food, Drug, and Cosmetic
Act.
(3) High need cure.--The term ``high need cure''
means a drug (as that term is defined by section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act,
biological product (as that term is defined by section
262(i)), or device (as that term is defined by section
201(h) of the Federal Food, Drug, and Cosmetic Act)
that, in the determination of the Director of NIH--
(A) is a priority to diagnose, mitigate,
prevent, or treat harm from any disease or
condition; and
(B) for which the incentives of the
commercial market are unlikely to result in its
adequate or timely development.
(4) Medical product.--The term ``medical product''
means a drug, device, biological product, or product
that is a combination of drugs, devices, and biological
products.
(b) Establishment of the Cures Acceleration Network.--
Subject to the appropriation of funds as described in
subsection (g), there is established within the Office of the
Director of NIH a program to be known as the Cures Acceleration
Network (referred to in this section as ``CAN''), which shall--
(1) be under the direction of the Director of NIH,
taking into account the recommendations of a CAN Review
Board (referred to in this section as the ``Board''),
described in subsection (d); and
(2) award grants and contracts to eligible
entities, as described in subsection (e), to accelerate
the development of high need cures, including through
the development of medical products and behavioral
therapies.
(c) Functions.--The functions of the CAN are to--
(1) conduct and support revolutionary advances in
basic research, translating scientific discoveries from
bench to bedside;
(2) award grants and contracts to eligible entities
to accelerate the development of high need cures;
(3) provide the resources necessary for government
agencies, independent investigators, research
organizations, biotechnology companies, academic
research institutions, and other entities to develop
high need cures;
(4) reduce the barriers between laboratory
discoveries and clinical trials for new therapies; and
(5) facilitate review in the Food and Drug
Administration for the high need cures funded by the
CAN, through activities that may include--
(A) the facilitation of regular and ongoing
communication with the Food and Drug
Administration regarding the status of
activities conducted under this section;
(B) ensuring that such activities are
coordinated with the approval requirements of
the Food and Drug Administration, with the goal
of expediting the development and approval of
countermeasures and products; and
(C) connecting interested persons with
additional technical assistance made available
under section 565 of the Federal Food, Drug,
and Cosmetic Act.
(d) CAN Board.--
(1) Establishment.--There is established a Cures
Acceleration Network Review Board (referred to in this
section as the ``Board''), which shall advise the
Director of NIH on the conduct of the activities of the
Cures Acceleration Network.
(2) Membership.--
(A) In general.--
(i) Appointment.--The Board shall
be comprised of 24 members who are
appointed by the Secretary and who
serve at the pleasure of the Secretary.
(ii) Chairperson and vice
chairperson.--The Secretary shall
designate, from among the 24 members
appointed under clause (i), one
Chairperson of the Board (referred to
in this section as the ``Chairperson'')
and one Vice Chairperson.
(B) Terms.--
(i) In general.--Each member shall
be appointed to serve a 4-year term,
except that any member appointed to
fill a vacancy occurring prior to the
expiration of the term for which the
member's predecessor was appointed
shall be appointed for the remainder of
such term.
(ii) Consecutive appointments;
maximum terms.--A member may be
appointed to serve not more than 3
terms on the Board, and may not serve
more than 2 such terms consecutively.
(C) Qualifications.--
(i) In general.--The Secretary
shall appoint individuals to the Board
based solely upon the individual's
established record of distinguished
service in one of the areas of
expertise described in clause (ii).
Each individual appointed to the Board
shall be of distinguished achievement
and have a broad range of disciplinary
interests.
(ii) Expertise.--The Secretary
shall select individuals based upon the
following requirements:
(I) For each of the fields
of--
(aa) basic
research;
(bb) medicine;
(cc)
biopharmaceuticals;
(dd) discovery and
delivery of medical
products;
(ee) bioinformatics
and gene therapy;
(ff) medical
instrumentation; and
(gg) regulatory
review and approval of
medical products,
the Secretary shall select at
least 1 individual who is
eminent in such fields.
(II) At least 4 individuals
shall be recognized leaders in
professional venture capital or
private equity organizations
and have demonstrated
experience in private equity
investing.
(III) At least 8
individuals shall represent
disease advocacy organizations.
(3) Ex-officio members.--
(A) Appointment.--In addition to the 24
Board members described in paragraph (2), the
Secretary shall appoint as ex-officio members
of the Board--
(i) a representative of the
National Institutes of Health,
recommended by the Secretary of the
Department of Health and Human
Services;
(ii) a representative of the Office
of the Assistant Secretary of Defense
for Health Affairs, recommended by the
Secretary of Defense;
(iii) a representative of the
Office of the Under Secretary for
Health for the Veterans Health
Administration, recommended by the
Secretary of Veterans Affairs;
(iv) a representative of the
National Science Foundation,
recommended by the Chair of the
National Science Board; and
(v) a representative of the Food
and Drug Administration, recommended by
the Commissioner of Food and Drugs.
(B) Terms.--Each ex-officio member shall
serve a 3-year term on the Board, except that
the Chairperson may adjust the terms of the
initial ex-officio members in order to provide
for a staggered term of appointment for all
such members.
(4) Responsibilities of the board and the director
of nih.--
(A) Responsibilities of the board.--
(i) In general.--The Board shall
advise, and provide recommendations to,
the Director of NIH with respect to--
(I) policies, programs, and
procedures for carrying out the
duties of the Director of NIH
under this section; and
(II) significant barriers
to successful translation of
basic science into clinical
application (including issues
under the purview of other
agencies and departments).
(ii) Report.--In the case that the
Board identifies a significant barrier,
as described in clause (i)(II), the
Board shall submit to the Secretary a
report regarding such barrier.
(B) Responsibilities of the director of
nih.--With respect to each recommendation
provided by the Board under subparagraph
(A)(i), the Director of NIH shall respond in
writing to the Board, indicating whether such
Director will implement such recommendation. In
the case that the Director of NIH indicates a
recommendation of the Board will not be
implemented, such Director shall provide an
explanation of the reasons for not implementing
such recommendation.
(5) Meetings.--
(A) In general.--The Board shall meet 4
times per calendar year, at the call of the
Chairperson.
(B) Quorum; requirements; limitations.--
(i) Quorum.--A quorum shall consist
of a total of 13 members of the Board,
excluding ex-officio members, with
diverse representation as described in
clause (iii).
(ii) Chairperson or vice
chairperson.--Each meeting of the Board
shall be attended by either the
Chairperson or the Vice Chairperson.
(iii) Diverse representation.--At
each meeting of the Board, there shall
be not less than one scientist, one
representative of a disease advocacy
organization, and one representative of
a professional venture capital or
private equity organization.
(6) Compensation and travel expenses.--
(A) Compensation.--Members shall receive
compensation at a rate to be fixed by the
Chairperson but not to exceed a rate equal to
the daily equivalent of the annual rate of
basic pay prescribed for level IV of the
Executive Schedule under section 5315 of title
5, United States Code, for each day (including
travel time) during which the member is engaged
in the performance of the duties of the Board.
All members of the Board who are officers or
employees of the United States shall serve
without compensation in addition to that
received for their services as officers or
employees of the United States.
(B) Travel expenses.--Members of the Board
shall be allowed travel expenses, including per
diem in lieu of subsistence, at rates
authorized for persons employed intermittently
by the Federal Government under section 5703(b)
of title 5, United States Code, while away from
their homes or regular places of business in
the performance of services for the Board.
(e) Grant Program.--
(1) Supporting innovation.--To carry out the
purposes described in this section, the Director of NIH
shall award contracts, grants, or cooperative
agreements to the entities described in paragraph (2),
to--
(A) promote innovation in technologies
supporting the advanced research and
development and production of high need cures,
including through the development of medical
products and behavioral therapies.
(B) accelerate the development of high need
cures, including through the development of
medical products, behavioral therapies, and
biomarkers that demonstrate the safety or
effectiveness of medical products; or
(C) help the award recipient establish
protocols that comply with Food and Drug
Administration standards and otherwise permit
the recipient to meet regulatory requirements
at all stages of development, manufacturing,
review, approval, and safety surveillance of a
medical product.
(2) Eligible entities.--To receive assistance under
paragraph (1), an entity shall--
(A) be a public or private entity, which
may include a private or public research
institution, an institution of higher
education, a medical center, a biotechnology
company, a pharmaceutical company, a disease
advocacy organization, a patient advocacy
organization, or an academic research
institution;
(B) submit an application containing--
(i) a detailed description of the
project for which the entity seeks such
grant or contract;
(ii) a timetable for such project;
(iii) an assurance that the entity
will submit--
(I) interim reports
describing the entity's--
(aa) progress in
carrying out the
project; and
(bb) compliance
with all provisions of
this section and
conditions of receipt
of such grant or
contract; and
(II) a final report at the
conclusion of the grant period,
describing the outcomes of the
project; and
(iv) a description of the protocols
the entity will follow to comply with
Food and Drug Administration standards
and regulatory requirements at all
stages of development, manufacturing,
review, approval, and safety
surveillance of a medical product; and
(C) provide such additional information as
the Director of NIH may require.
(3) Awards.--
(A) The cures acceleration partnership
awards.--
(i) Initial award amount.--Each
award under this subparagraph shall be
not more than $15,000,000 per project
for the first fiscal year for which the
project is funded, which shall be
payable in one payment.
(ii) Funding in subsequent fiscal
years.--An eligible entity receiving an
award under clause (i) may apply for
additional funding for such project by
submitting to the Director of NIH the
information required under
subparagraphs (B) and (C) of paragraph
(2). The Director may fund a project of
such eligible entity in an amount not
to exceed $15,000,000 for a fiscal year
subsequent to the initial award under
clause (i).
(iii) Matching funds.--As a
condition for receiving an award under
this subsection, an eligible entity
shall contribute to the project non-
Federal funds in the amount of $1 for
every $3 awarded under clauses (i) and
(ii), except that the Director of NIH
may waive or modify such matching
requirement in any case where the
Director determines that the goals and
objectives of this section cannot
adequately be carried out unless such
requirement is waived.
(B) The cures acceleration grant awards.--
(i) Initial award amount.--Each
award under this subparagraph shall be
not more than $15,000,000 per project
for the first fiscal year for which the
project is funded, which shall be
payable in one payment.
(ii) Funding in subsequent fiscal
years.--An eligible entity receiving an
award under clause (i) may apply for
additional funding for such project by
submitting to the Board the information
required under subparagraphs (B) and
(C) of paragraph (2). The Director of
NIH may fund a project of such eligible
entity in an amount not to exceed
$15,000,000 for a fiscal year
subsequent to the initial award under
clause (i).
(C) The cures acceleration flexible
research awards.--If the Director of NIH
determines that the goals and objectives of
this section cannot adequately be carried out
through a contract, grant, or cooperative
agreement, the Director of NIH shall have
flexible research authority to use other
transactions to fund projects in accordance
with the terms and conditions of this section.
Awards made under such flexible research
authority for a fiscal year shall not exceed 20
percent of the total funds appropriated under
subsection (g)(1) for such fiscal year.
(4) Suspension of awards for defaults,
noncompliance with provisions and plans, and diversion
of funds; repayment of funds.--The Director of NIH may
suspend the award to any entity upon noncompliance by
such entity with provisions and plans under this
section or diversion of funds.
(5) Audits.--The Director of NIH may enter into
agreements with other entities to conduct periodic
audits of the projects funded by grants or contracts
awarded under this subsection.
(6) Closeout procedures.--At the end of a grant or
contract period, a recipient shall follow the closeout
procedures under section 74.71 of title 45, Code of
Federal Regulations (or any successor regulation).
(7) Review.--A determination by the Director of NIH
as to whether a drug, device, or biological product is
a high need cure (for purposes of subsection (a)(3))
shall not be subject to judicial review.
(f) Competitive Basis of Awards.--Any grant, cooperative
agreement, or contract awarded under this section shall be
awarded on a competitive basis.
(g) Authorization of Appropriations.--
(1) In general.--For purposes of carrying out this
section, there are authorized to be appropriated
$500,000,000 for fiscal year 2010, and such sums as may
be necessary for subsequent fiscal years. Funds
appropriated under this section shall be available
until expended.
(2) Limitation on use of funds otherwise
appropriated.--No funds appropriated under this Act,
other than funds appropriated under paragraph (1), may
be allocated to the Cures Acceleration Network.
SEC. 403. [283] BIENNIAL REPORTS OF DIRECTOR OF NIH.
(a) In General.--The Director of NIH shall submit to the
Congress on a biennial basis a report in accordance with this
section. The first report shall be submitted not later than 1
year after the date of the enactment of the National Institutes
of Health Reform Act of 2006. Each such report shall include
the following information:
(1) An assessment of the state of biomedical and
behavioral research.
(2) A description of the activities conducted or
supported by the agencies of the National Institutes of
Health and policies respecting the programs of such
agencies.
(3) Classification and justification for the
priorities established by the agencies, including a
strategic plan and recommendations for future research
initiatives to be carried out under section 402(b)(7)
through the Division of Program Coordination, Planning,
and Strategic Initiatives.
(4) A catalog of all the research activities of the
agencies, prepared in accordance with the following:
(A) The catalog shall, for each such
activity--
(i) identify the agency or agencies
involved;
(ii) state whether the activity was
carried out directly by the agencies or
was supported by the agencies and
describe to what extent the agency was
involved; and
(iii) identify whether the activity
was carried out through a center of
excellence.
(B) In the case of clinical research, the
catalog shall, as appropriate, identify study
populations by demographic variables and other
variables that contribute to research on
minority health and health disparities.
(C) Research activities listed in the
catalog shall include, where applicable, the
following:
(i) Epidemiological studies and
longitudinal studies.
(ii) Disease registries,
information clearinghouses, and other
data systems.
(iii) Public education and
information campaigns.
(iv) Training activities,
including--
(I) National Research
Service Awards and Clinical
Transformation Science Awards;
(II) graduate medical
education programs, including
information on the number and
type of graduate degrees
awarded during the period in
which the programs received
funding under this title;
(III) investigator-
initiated awards for
postdoctoral training and
postdoctoral training funded
through research grants;
(IV) a breakdown by
demographic variables and other
appropriate categories; and
(V) an evaluation and
comparison of outcomes and
effectiveness of various
training programs.
(v) Clinical trials, including a
breakdown of participation by study
populations and demographic variables
and such other information as may be
necessary to demonstrate compliance
with section 492B (regarding inclusion
of women and minorities in clinical
research).
(vi) Translational research
activities with other agencies of the
Public Health Service.
(5) A summary of the research activities throughout
the agencies, which summary shall be organized by the
following categories, where applicable:
(A) Cancer.
(B) Neurosciences.
(C) Life stages, human development, and
rehabilitation.
(D) Organ systems.
(E) Autoimmune diseases.
(F) Genomics.
(G) Molecular biology and basic science.
(H) Technology development.
(I) Chronic diseases, including pain and
palliative care.
(J) Infectious diseases and bioterrorism.
(K) Minority health and health disparities.
(L) Such additional categories as the
Director determines to be appropriate.
(6) A review of each entity receiving funding under
this title in its capacity as a center of excellence
(in this paragraph referred to as a ``center of
excellence''), including the following:
(A) An evaluation of the performance and
research outcomes of each center of excellence.
(B) Recommendations for promoting
coordination of information among the centers
of excellence.
(C) Recommendations for improving the
effectiveness, efficiency, and outcomes of the
centers of excellence.
(D) If no additional centers of excellence
have been funded under this title since the
previous report under this section, an
explanation of the reasons for not funding any
additional centers.
(b) Requirement Regarding Disease-Specific Research
Activities.--In a report under subsection (a), the Director of
NIH, when reporting on research activities relating to a
specific disease, disorder, or other adverse health condition,
shall--
(1) present information in a standardized format;
(2) identify the actual dollar amounts obligated
for such activities; and
(3) include a plan for research on the specific
disease, disorder, or other adverse health condition,
including a statement of objectives regarding the
research, the means for achieving the objectives, a
date by which the objectives are expected to be
achieved, and justifications for revisions to the plan.
(c) Additional Reports.--In addition to reports required by
subsections (a) and (b), the Director of NIH or the head of a
national research institute or national center may submit to
the Congress such additional reports as the Director or the
head of such institute or center determines to be appropriate.
SEC. 403A. [283A] ANNUAL REPORTING TO INCREASE INTERAGENCY
COLLABORATION AND COORDINATION.
(a) Collaboration With Other HHS Agencies.--On an annual
basis, the Director of NIH shall submit to the Secretary a
report on the activities of the National Institutes of Health
involving collaboration with other agencies of the Department
of Health and Human Services.
(b) Clinical Trials.--Each calendar year, the Director of
NIH shall submit to the Commissioner of Food and Drugs a report
that identifies each clinical trial that is registered during
such calendar year in the databank of information established
under section 402(i).
(c) Human Tissue Samples.--On an annual basis, the Director
of NIH shall submit to the Congress a report that describes how
the National Institutes of Health and its agencies store and
track human tissue samples.
(d) First Report.--The first report under subsections (a),
(b), and (c) shall be submitted not later than 1 year after the
date of the enactment of the National Institutes of Health
Reform Act of 2006.
SEC. 403B. [283A-1] ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.
(a) Whistleblower Complaints.--
(1) In general.--On an annual basis, the Director
of NIH shall submit to the Inspector General of the
Department of Health and Human Services, the Secretary,
the Committee on Energy and Commerce and the Committee
on Appropriations of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate a
report summarizing the activities of the National
Institutes of Health relating to whistleblower
complaints.
(2) Contents.--For each whistleblower complaint
pending during the year for which a report is submitted
under this subsection, the report shall identify the
following:
(A) Each agency of the National Institutes
of Health involved.
(B) The status of the complaint.
(C) The resolution of the complaint to
date.
(b) Experts and Consultants.--On an annual basis, the
Director of NIH shall submit to the Inspector General of the
Department of Health and Human Services, the Secretary, the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate a report that--
(1) identifies the number of experts and
consultants, including any special consultants, whose
services are obtained by the National Institutes of
Health or its agencies;
(2) specifies whether such services were obtained
under section 207(f), section 402(d), or other
authority;
(3) describes the qualifications of such experts
and consultants;
(4) describes the need for hiring such experts and
consultants; and
(5) if such experts and consultants make financial
disclosures to the National Institutes of Health or any
of its agencies, specifies the income, gifts, assets,
and liabilities so disclosed.
(c) First Report.--The first report under subsections (a)
and (b) shall be submitted not later than 1 year after the date
of the enactment of the National Institutes of Health Reform
Act of 2006.
SEC. 403C. [283A-2] ANNUAL REPORTING REGARDING TRAINING OF GRADUATE
STUDENTS FOR DOCTORAL DEGREES.
(a) In General.--Each institution receiving an award under
this title for the training of graduate students for doctoral
degrees shall annually report to the Director of NIH, with
respect to graduate students supported by the National
Institutes of Health at such institution--
(1) the percentage of such students admitted for
study who successfully attain a doctoral degree; and
(2) for students described in paragraph (1), the
average time (not including any leaves of absence)
between the beginning of graduate study and the receipt
of a doctoral degree.
(3) \1\ Provision of information to applicants.--
Each institution described in subsection (a) shall
provide to each student submitting an application for a
program of graduate study at such institution the
information described in paragraphs (1) and (2) of such
subsection with respect to the program or programs to
which such student has applied.
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\1\ So in law. Paragraph (3) probably should be subsection (b).
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des
Sec. 403D. [283a-3] (a) The Director of NIH shall establish
a program for the conduct and support of research and training,
the dissemination of health information, and other programs
with respect to the diagnosis and treatment of conditions
associated with exposure to the drug diethylstilbestrol (in
this section referred to as ``DES'').
(b) In carrying out subsection (a), the Director of NIH,
after consultation with nonprofit private entities representing
individuals who have been exposed to DES, shall conduct or
support programs to educate health professionals and the public
on the drug, including the importance of identifying and
treating individuals who have been exposed to the drug.
(c) After consultation with the Office of Research on
Women's Health, the Director of NIH, acting through the
appropriate national research institutes, shall in carrying out
subsection (a) conduct or support one or more longitudinal
studies to determine the incidence of the following diseases or
disorders in the indicated populations and the relationship of
DES to the diseases or disorders:
(1) In the case of women to whom (on or after
January 1, 1938) DES was administered while the women
were pregnant, the incidence of all diseases and
disorders (including breast cancer, gynecological
cancers, and impairments of the immune system,
including autoimmune disease).
(2) In the case of women exposed to DES in utero,
the incidence of clear cell cancer (including
recurrences), the long-term health effects of such
cancer, and the effects of treatments for such cancer.
(3) In the case of men and women exposed to DES in
utero, the incidence of all diseases and disorders
(including impairments of the reproductive and
autoimmune systems).
(4) In the case of children of men or women exposed
to DES in utero, the incidence of all diseases and
disorders.
(d) For purposes of this section, an individual shall be
considered to have been exposed to DES in utero if, during the
pregnancy that resulted in the birth of such individual, DES
was (on or after January 1, 1938) administered to the
biological mother of the individual.
office of behavioral and social sciences research
Sec. 404A. \1\ [283c] (a) There is established within the
Office of the Director of NIH an office to be known as the
Office of Behavioral and Social Sciences Research (in this
section referred to as the ``Office''). The Office shall be
headed by a director, who shall be appointed by the Director of
NIH.
---------------------------------------------------------------------------
\1\ Section 404 was struck by section 101(b)(2) of Public Law 106-
525 (114 Stat. 2501).
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(b)(1) With respect to research on the relationship between
human behavior and the development, treatment, and prevention
of medical conditions, the Director of the Office shall--
(A) coordinate research conducted or supported by
the agencies of the National Institutes of Health; and
(B) identify projects of behavioral and social
sciences research that should be conducted or supported
by the national research institutes, and develop such
projects in cooperation with such institutes.
(2) Research authorized under paragraph (1) includes
research on teen pregnancy, infant mortality, violent behavior,
suicide, and homelessness. Such research does not include
neurobiological research, or research in which the behavior of
an organism is observed for the purpose of determining activity
at the cellular or molecular level.
children's vaccine initiative
Sec. 404B. [283d] (a) Development of New Vaccines.--The
Secretary, in consultation with the Director of the National
Vaccine Program under title XXI and acting through the
Directors of the National Institute for Allergy and Infectious
Diseases, the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, the National Institute for
Aging, and other public and private programs, shall carry out
activities, which shall be consistent with the global
Children's Vaccine Initiative, to develop affordable new and
improved vaccines to be used in the United States and in the
developing world that will increase the efficacy and efficiency
of the prevention of infectious diseases. In carrying out such
activities, the Secretary shall, to the extent practicable,
develop and make available vaccines that require fewer contacts
to deliver, that can be given early in life, that provide long
lasting protection, that obviate refrigeration, needles and
syringes, and that protect against a larger number of diseases.
(b) Report.--In the report required in section 2104 \1\,
the Secretary, acting through the Director of the National
Vaccine Program under title XXI, shall include information with
respect to activities and the progress made in implementing the
provisions of this section and achieving its goals.
---------------------------------------------------------------------------
\1\ Section 2104 was repealed by section 601(a)(1)(H) of Public Law
105-362 (112 Stat. 3285).
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h3 deg.plan for use of animals in research
Sec. 404C. [283e] (a) The Director of NIH, after
consultation with the committee established under subsection
(e), shall prepare a plan--
(1) for the National Institutes of Health to
conduct or support research into--
(A) methods of biomedical research and
experimentation that do not require the use of
animals;
(B) methods of such research and
experimentation that reduce the number of
animals used in such research;
(C) methods of such research and
experimentation that produce less pain and
distress in such animals; and
(D) methods of such research and
experimentation that involve the use of marine
life (other than marine mammals);
(2) for establishing the validity and reliability
of the methods described in paragraph (1);
(3) for encouraging the acceptance by the
scientific community of such methods that have been
found to be valid and reliable; and
(4) for training scientists in the use of such
methods that have been found to be valid and reliable.
(b) Not later than October 1, 1993, the Director of NIH
shall submit to the Committee on Energy and Commerce of the
House of Representatives, and to the Committee on Labor and
Human Resources of the Senate, the plan required in subsection
(a) and shall begin implementation of the plan.
(c) The Director of NIH shall periodically review, and as
appropriate, make revisions in the plan required under
subsection (a). A description of any revision made in the plan
shall be included in the first biennial report under section
403 that is submitted after the revision is made.
(d) The Director of NIH shall take such actions as may be
appropriate to convey to scientists and others who use animals
in biomedical or behavioral research or experimentation
information respecting the methods found to be valid and
reliable under subsection (a)(2).
(e)(1) The Director of NIH shall establish within the
National Institutes of Health a committee to be known as the
Interagency Coordinating Committee on the Use of Animals in
Research (in this subsection referred to as the ``Committee'').
(2) The Committee shall provide advice to the Director of
NIH on the preparation of the plan required in subsection (a).
(3) The Committee shall be composed of--
(A) the Directors of each of the national research
institutes and the Director of the Center for Research
Resources (or the designees of such Directors); and
(B) representatives of the Environmental Protection
Agency, the Food and Drug Administration, the Consumer
Product Safety Commission, the National Science
Foundation, and such additional agencies as the
Director of NIH determines to be appropriate, which
representatives shall include not less than one
veterinarian with expertise in laboratory-animal
medicine.
requirements regarding surveys of sexual behavior
Sec. 404D. [283f] With respect to any survey of human
sexual behavior proposed to be conducted or supported through
the National Institutes of Health, the survey may not be
carried out unless--
(1) the proposal has undergone review in accordance
with any applicable requirements of sections 491 and
492; and
(2) the Secretary, in accordance with section 492A,
makes a determination that the information expected to
be obtained through the survey will assist--
(A) in reducing the incidence of sexually
transmitted diseases, the incidence of
infection with the human immunodeficiency
virus, or the incidence of any other infectious
disease; or
(B) in improving reproductive health or
other conditions of health.
SEC. 404E. [283G] MUSCULAR DYSTROPHY; INITIATIVE THROUGH DIRECTOR OF
NATIONAL INSTITUTES OF HEALTH.
(a) Expansion, Intensification, and Coordination of
Activities.--
(1) In general.--The Director of NIH, in
coordination with the Directors of the National
Institute of Neurological Disorders and Stroke, the
National Institute of Arthritis and Muscoskeletal and
Skin Diseases, the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, the
National Heart, Lung, and Blood Institute, and the
other national research institutes as appropriate,
shall expand and intensify programs of such Institutes
with respect to research and related activities
concerning various forms of muscular dystrophy,
including Duchenne, myotonic, facioscapulohumeral
muscular dystrophy (referred to in this section as
``FSHD'') and other forms of muscular dystrophy.
(2) Coordination.--The Directors referred to in
paragraph (1) shall jointly coordinate the programs
referred to in such paragraph and consult with the
Muscular Dystrophy Interagency Coordinating Committee
established under section 6 of the MD-CARE Act.
(3) Allocations by director of nih.--The Director
of NIH shall allocate the amounts appropriated to carry
out this section for each fiscal year among the
national research institutes referred to in paragraph
(1).
(b) Centers of Excellence.--
(1) In general.--The Director of NIH shall award
grants and contracts under subsection (a)(1) to public
or nonprofit private entities to pay all or part of the
cost of planning, establishing, improving, and
providing basic operating support for centers of
excellence regarding research on various forms of
muscular dystrophy. Such centers of excellence shall be
known as the ``Paul D. Wellstone Muscular Dystrophy
Cooperative Research Centers''.
(2) Research.--Each center under paragraph (1)
shall supplement but not replace the establishment of a
comprehensive research portfolio in all the muscular
dystrophies. As a whole, the centers shall conduct
basic and clinical research in all forms of muscular
dystrophy including early detection, diagnosis,
prevention, and treatment, including the fields of
muscle biology, genetics, noninvasive imaging,
genetics, pharmacological and other therapies.
(3) Coordination of centers.--The Director of NIH
shall, as appropriate, provide for the coordination of
information among centers under paragraph (1) and
ensure regular communication between such centers.
(4) Organization of centers.--Each center under
paragraph (1) shall use the facilities of a single
institution, or be formed from a consortium of
cooperating institutions, meeting such requirements as
may be prescribed by the Director of NIH.
(5) Duration of support.--Support for a center
established under paragraph (1) may be provided under
this section for a period of not to exceed 5 years.
Such period may be extended for 1 or more additional
periods not exceeding 5 years if the operations of such
center have been reviewed by an appropriate technical
and scientific peer review group established by the
Director of NIH and if such group has recommended to
the Director that such period should be extended.
(c) Facilitation of Research.--The Director of NIH shall
provide for a program under subsection (a)(1) under which
samples of tissues and genetic materials that are of use in
research on muscular dystrophy are donated, collected,
preserved, and made available for such research. The program
shall be carried out in accordance with accepted scientific and
medical standards for the donation, collection, and
preservation of such samples.
(d) Coordinating Committee.--
(1) In general.--The Secretary shall establish the
Muscular Dystrophy Coordinating Committee (referred to
in this section as the ``Coordinating Committee'') to
coordinate activities across the National Institutes
and with other Federal health programs and activities
relating to the various forms of muscular dystrophy.
(2) Composition.--The Coordinating Committee shall
consist of not more than 15 members to be appointed by
the Secretary, of which--
(A) \2/3\ of such members shall represent
governmental agencies, including the directors
or their designees of each of the national
research institutes involved in research with
respect to muscular dystrophy and
representatives of all other Federal
departments and agencies whose programs involve
health functions or responsibilities relevant
to such diseases, including the Centers for
Disease Control and Prevention, the Health
Resources and Services Administration and the
Food and Drug Administration and
representatives of other governmental agencies
that serve children with muscular dystrophy,
such as the Department of Education; and
(B) \1/3\ of such members shall be public
members, including a broad cross section of
persons affected with muscular dystrophies
including parents or legal guardians, affected
individuals, researchers, and clinicians.
Members appointed under subparagraph (B) shall serve
for a term of 3 years, and may serve for an unlimited
number of terms if reappointed.
(3) Chair.--
(A) In general.--With respect to muscular
dystrophy, the Chair of the Coordinating
Committee shall serve as the principal advisor
to the Secretary, the Assistant Secretary for
Health, and the Director of NIH, and shall
provide advice to the Director of the Centers
for Disease Control and Prevention, the
Commissioner of Food and Drugs, and to the
heads of other relevant agencies. The
Coordinating Committee shall select the Chair
for a term not to exceed 2 years.
(B) Appointment.--The Chair of the
Committee shall be appointed by and be directly
responsible to the Secretary.
(4) Administrative support; terms of service; other
provisions.--The following shall apply with respect to
the Coordinating Committee:
(A) The Coordinating Committee shall
receive necessary and appropriate
administrative support from the Department of
Health and Human Services.
(B) The Coordinating Committee shall meet
as appropriate as determined by the Secretary,
in consultation with the chair.
(e) Plan for HHS Activities.--
(1) In general.--Not later than 1 year after the
date of enactment of this section, the Coordinating
Committee shall develop a plan for conducting and
supporting research and education on muscular dystrophy
through the national research institutes and shall
periodically review and revise the plan. The plan
shall--
(A) provide for a broad range of research
and education activities relating to
biomedical, epidemiological, psychosocial, and
rehabilitative issues, including studies of the
impact of such diseases in rural and
underserved communities;
(B) identify priorities among the programs
and activities of the National Institutes of
Health regarding such diseases; and
(C) reflect input from a broad range of
scientists, patients, and advocacy groups.
(2) Certain elements of plan.--The plan under
paragraph (1) shall, with respect to each form of
muscular dystrophy, provide for the following as
appropriate:
(A) Research to determine the reasons
underlying the incidence and prevalence of
various forms of muscular dystrophy.
(B) Basic research concerning the etiology
and genetic links of the disease and potential
causes of mutations.
(C) The development of improved screening
techniques.
(D) Basic and clinical research for the
development and evaluation of new treatments,
including new biological agents.
(E) Information and education programs for
health care professionals and the public.
(f) Public Input.--The Secretary shall, under subsection
(a)(1), provide for a means through which the public can obtain
information on the existing and planned programs and activities
of the Department of Health and Human Services with respect to
various forms of muscular dystrophy and through which the
Secretary can receive comments from the public regarding such
programs and activities.
(g) Clinical Research.--The Coordinating Committee may
evaluate the potential need to enhance the clinical research
infrastructure required to test emerging therapies for the
various forms of muscular dystrophy by prioritizing the
achievement of the goals related to this topic in the plan
under subsection (e)(1).
office of rare diseases
Sec. 404F. [283h] (a) Establishment.--There is established
within the Office of the Director of NIH an office to be known
as the Office of Rare Diseases (in this section referred to as
the ``Office''), which shall be headed by a Director (in this
section referred to as the ``Director''), appointed by the
Director of NIH.
(b) Duties.--
(1) In general.--The Director of the Office shall
carry out the following:
(A) The Director shall recommend an agenda
for conducting and supporting research on rare
diseases through the national research
institutes and centers. The agenda shall
provide for a broad range of research and
education activities, including scientific
workshops and symposia to identify research
opportunities for rare diseases.
(B) The Director shall, with respect to
rare diseases, promote coordination and
cooperation among the national research
institutes and centers and entities whose
research is supported by such institutes.
(C) The Director, in collaboration with the
directors of the other relevant institutes and
centers of the National Institutes of Health,
may enter into cooperative agreements with and
make grants for regional centers of excellence
on rare diseases in accordance with section
404G.
(D) The Director shall promote the
sufficient allocation of the resources of the
National Institutes of Health for conducting
and supporting research on rare diseases.
(E) The Director shall promote and
encourage the establishment of a centralized
clearinghouse for rare and genetic disease
information that will provide understandable
information about these diseases to the public,
medical professionals, patients and families.
(2) Principal advisor regarding orphan diseases.--
With respect to rare diseases, the Director shall serve
as the principal advisor to the Director of NIH and
shall provide advice to other relevant agencies. The
Director shall provide liaison with national and
international patient, health and scientific
organizations concerned with rare diseases.
(c) Definition.--For purposes of this section, the term
``rare disease'' means any disease or condition that affects
less than 200,000 persons in the United States.
rare disease regional centers of excellence
Sec. 404G. [283i] (a) Cooperative Agreements and Grants.--
(1) In general.--The Director of the Office of Rare
Diseases (in this section referred to as the
``Director''), in collaboration with the directors of
the other relevant institutes and centers of the
National Institutes of Health, may enter into
cooperative agreements with and make grants to public
or private nonprofit entities to pay all or part of the
cost of planning, establishing, or strengthening, and
providing basic operating support for regional centers
of excellence for clinical research into, training in,
and demonstration of diagnostic, prevention, control,
and treatment methods for rare diseases.
(2) Policies.--A cooperative agreement or grant
under paragraph (1) shall be entered into in accordance
with policies established by the Director of NIH.
(b) Coordination With Other Institutes.--The Director shall
coordinate the activities under this section with similar
activities conducted by other national research institutes,
centers and agencies of the National Institutes of Health and
by the Food and Drug Administration to the extent that such
institutes, centers and agencies have responsibilities that are
related to rare diseases.
(c) Uses for Federal Payments Under Cooperative Agreements
or Grants.--Federal payments made under a cooperative agreement
or grant under subsection (a) may be used for--
(1) staffing, administrative, and other basic
operating costs, including such patient care costs as
are required for research;
(2) clinical training, including training for
allied health professionals, continuing education for
health professionals and allied health professions
personnel, and information programs for the public with
respect to rare diseases; and
(3) clinical research and demonstration programs.
(d) Period of Support; Additional Periods.--Support of a
center under subsection (a) may be for a period of not to
exceed 5 years. Such period may be extended by the Director for
additional periods of not more than 5 years if the operations
of such center have been reviewed by an appropriate technical
and scientific peer review group established by the Director
and if such group has recommended to the Director that such
period should be extended.
SEC. 404H. [283J] REVIEW OF CENTERS OF EXCELLENCE.
(a) In General.--Not later than April 1, 2008, and
periodically thereafter, the Secretary, acting through the
Director of NIH, shall conduct a review and submit a report to
the appropriate committees of the Congress on the centers of
excellence.
(b) Report Contents.--Each report under subsection (a)
shall include the following:
(1) Evaluation of the performance and research
outcomes of each center of excellence.
(2) Recommendations for promoting coordination of
information among centers of excellence.
(3) Recommendations for improving the
effectiveness, efficiency, and outcomes of the centers
of excellence.
(c) Definition.--In this section, the term ``center of
excellence'' means an entity receiving funding under this title
in its capacity as a center of excellence.
Part B--General Provisions Respecting National Research Institutes
appointment and authority of the directors of the national research
institutes
Sec. 405. [284] (a) The Director of the National Cancer
Institute shall be appointed by the President and the Directors
of the other national research institutes shall be appointed by
the Secretary. Each Director of a national research institute
shall report directly to the Director of NIH.
(b)(1) In carrying out the purposes of section 301 with
respect to human diseases or disorders or other aspects of
human health for which the national research institutes were
established, the Secretary, acting through the Director of each
national research institute--
(A) shall encourage and support research,
investigations, experiments, demonstrations, and
studies in the health sciences related to--
(i) the maintenance of health,
(ii) the detection, diagnosis, treatment,
and prevention of human diseases and disorders,
(iii) the rehabilitation of individuals
with human diseases, disorders, and
disabilities, and
(iv) the expansion of knowledge of the
processes underlying human diseases, disorders,
and disabilities, the processes underlying the
normal and pathological functioning of the body
and its organ systems, and the processes
underlying the interactions between the human
organism and the environment;
(B) may, subject to the peer review prescribed
under section 492(b) and any advisory council review
under section 406(a)(3)(A)(i), conduct the research,
investigations, experiments, demonstrations, and
studies referred to in subparagraph (A);
(C) may conduct and support research training (i)
for which fellowship support is not provided under
section 487, and (ii) which is not residency training
of physicians or other health professionals;
(D) may develop, implement, and support
demonstrations and programs for the application of the
results of the activities of the institute to clinical
practice and disease prevention activities;
(E) may develop, conduct, and support public and
professional education and information programs;
(F) may secure, develop and maintain, distribute,
and support the development and maintenance of
resources needed for research;
(G) may make available the facilities of the
institute to appropriate entities and individuals
engaged in research activities and cooperate with and
assist Federal and State agencies charged with
protecting the public health;
(H) may accept unconditional gifts made to the
institute for its activities, and, in the case of gifts
of a value in excess of $50,000, establish suitable
memorials to the donor;
(I) may secure for the institute consultation
services and advice of persons from the United States
or abroad;
(J) may use, with their consent, the services,
equipment, personnel, information, and facilities of
other Federal, State, or local public agencies, with or
without reimbursement therefor;
(K) may accept voluntary and uncompensated
services; and
(L) may perform such other functions as the
Secretary determines are needed to carry out
effectively the purposes of the institute.
The indemnification provisions of section 2354, title 10,
United States Code, shall apply with respect to contracts
entered into under this subsection and section 402(b).
(2) Support for an activity or program under this
subsection may be provided through grants, contracts, and
cooperative agreements. The Secretary, acting through the
Director of each national research institute--
(A) may enter into a contract for research,
training, or demonstrations only if the contract has
been recommended after technical and scientific peer
review required by regulations under section 492;
(B) may make grants and cooperative agreements
under paragraph (1) for research, training, or
demonstrations, except that--
(i) if the direct cost of the grant or
cooperative agreement to be made does not
exceed $50,000, such grant or cooperative
agreement may be made only if such grant or
cooperative agreement has been recommended
after technical and scientific peer review
required by regulations under section 492, and
(ii) if the direct cost of the grant or
cooperative agreement to be made exceeds
$50,000, such grant or cooperative agreement
may be made only if such grant or cooperative
agreement has been recommended after technical
and scientific peer review required by
regulations under section 492 and is
recommended under section 406(a)(3)(A)(ii) by
the advisory council for the national research
institute involved; and
(C) shall, subject to section 2353(d)(2), receive
from the President and the Office of Management and
Budget directly all funds appropriated by the Congress
for obligation and expenditure by the Institute.
(c) In carrying out subsection (b), each Director of a
national research institute--
(1) shall coordinate, as appropriate, the
activities of the institute with similar programs of
other public and private entities;
(2) shall cooperate with the Directors of the other
national research institutes in the development and
support of multidisciplinary research and research that
involves more than one institute;
(3) may, in consultation with the advisory council
for the Institute and with the approval of the Director
of NIH--
(A) establish technical and scientific peer
review groups in addition to those appointed
under section 402(b)(16); and
(B) appoint the members of peer review groups
established under subparagraph (A); and
(4) may publish, or arrange for the publication of,
information with respect to the purpose of the
Institute without regard to section 501 of title 44,
United States Code.
The Federal Advisory Committee Act shall not apply to the
duration of a peer review group appointed under paragraph (3).
advisory councils
Sec. 406. [284a] (a)(1) Except as provided in subsection
(h), the Secretary shall appoint an advisory council for each
national research institute which (A) shall advise, assist,
consult with, and make recommendations to the Secretary and the
Director of such institute on matters related to the activities
carried out by and through the institute and the policies
respecting such activities, and (B) shall carry out the special
functions prescribed by part C.
(2) Each advisory council for a national research institute
may recommend to the Secretary acceptance, in accordance with
section 231, of conditional gifts for study, investigation, or
research respecting the diseases, disorders, or other aspect of
human health with respect to which the institute was
established, for the acquisition of grounds, or for the
construction, equipping, or maintenance of facilities for the
institute.
(3) Each advisory council for a national research
institute--
(A)(i) may on the basis of the materials provided
under section 492(b)(2) respecting research conducted
at the institute, make recommendations to the Director
of the institute respecting such research,
(ii) may review applications for grants and
cooperative agreements for research or training and for
which advisory council approval is required under
section 405(b)(2) and recommend for approval
applications for projects which show promise of making
valuable contributions to human knowledge, and
(iii) may review any grant, contract, or
cooperative agreement proposed to be made or entered
into by the institute;
(B) may collect, by correspondence or by personal
investigation, information as to studies which are
being carried on in the United States or any other
country as to the diseases, disorders, or other aspect
of human health with respect to which the institute was
established and with the approval of the Director of
the institute make available such information through
appropriate publications for the benefit of public and
private health entities and health professions
personnel and scientists and for the information of the
general public; and
(C) may appoint subcommittees and convene workshops
and conferences.
(b)(1) Each advisory council shall consist of ex officio
members and not more than eighteen members appointed by the
Secretary. The ex officio members shall be nonvoting members.
(2) The ex officio members of an advisory council shall
consist of--
(A) the Secretary, the Director of NIH, the
Director of the national research institute for which
the council is established, the Chief Medical Director
of the Department of Veterans Affairs or the Chief
Dental Director of the Department of Veterans Affairs,
and the Assistant Secretary of Defense for Health
Affairs (or the designees of such officers), and
(B) such additional officers or employees of the
United States as the Secretary determines necessary for
the advisory council to effectively carry out its
functions.
(3) The members of an advisory council who are not ex
officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by
the Secretary from among the leading representatives of
the health and scientific disciplines (including not
less than two individuals who are leaders in the fields
of public health and the behavioral or social sciences)
relevant to the activities of the national research
institute for which the advisory council is
established.
(B) One-third of the members shall be appointed by
the Secretary from the general public and shall include
leaders in fields of public policy, law, health policy,
economics, and management.
(4) Members of an advisory council who are officers or
employees of the United States shall not receive any
compensation for service on the advisory council. The other
members of an advisory council shall receive, for each day
(including traveltime) they are engaged in the performance of
the functions of the advisory council, compensation at rates
not to exceed the daily equivalent of the annual rate in effect
for grade GS-18 of the General Schedule.
(c) The term of office of an appointed member of an
advisory council is four years, except that any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term and the Secretary
shall make appointments to an advisory council in such a manner
as to ensure that the terms of the members do not all expire in
the same year. A member may serve after the expiration of the
member's term for 180 days after the date of such expiration. A
member who has been appointed for a term of four years may not
be reappointed to an advisory council before two years from the
date of expiration of such term of office. If a vacancy occurs
in the advisory council among the appointed members, the
Secretary shall make an appointment to fill the vacancy within
90 days from the date the vacancy occurs.
(d) The chairman of an advisory council shall be selected
by the Secretary from among the appointed members, except that
the Secretary may select the Director of the national research
institute for which the advisory council is established to be
the chairman of the advisory council. The term of office of the
chairman shall be two years.
(e) The advisory council shall meet at the call of the
chairman or upon the request of the Director of the national
research institute for which it was established, but at least
three times each fiscal year. The location of the meetings of
each advisory council is subject to the approval of the
Director of the national research institute for which the
advisory council was established.
(f) The Director of the national research institute for
which an advisory council is established shall designate a
member of the staff of the institute to serve as the executive
secretary of the advisory council. The Director of such
institute shall make available to the advisory council such
staff, information, and other assistance as it may require to
carry out its functions. The Director of such institute shall
provide orientation and training for new members of the
advisory council to provide them with such information and
training as may be appropriate for their effective
participation in the functions of the advisory council.
(g) Each advisory council may prepare, for inclusion in the
biennial report made under section 407, (1) comments respecting
the activities of the advisory council in the fiscal years
respecting which the report is prepared, (2) comments on the
progress of the national research institute for which it was
established in meeting its objectives, and (3) recommendations
respecting the future directions and program and policy
emphasis of the institute. Each advisory council may prepare
such additional reports as it may determine appropriate.
(h)(1) Except as provided in paragraph (2), this section
does not terminate the membership of any advisory council for a
national research institute which was in existence on the date
of enactment of the Health Research Extension Act of 1985.
After such date--
(A) the Secretary shall make appointments to each
such advisory council in such a manner as to bring
about as soon as practicable the composition for such
council prescribed by this section;
(B) each advisory council shall organize itself in
accordance with this section and exercise the functions
prescribed by this section; and
(C) the Director of each national research
institute shall perform for such advisory council the
functions prescribed by this section.
(2)(A) The National Cancer Advisory Board shall be the
advisory council for the National Cancer Institute. This
section applies to the National Cancer Advisory Board, except
that--
(i) appointments to such Board shall be made by the
President;
(ii) the term of office of an appointed member
shall be 6 years;
(iii) of the members appointed to the Board not
less than five members shall be individuals
knowledgeable in environmental carcinogenesis
(including carcinogenesis involving occupational and
dietary factors);
(iv) the chairman of the Board shall be selected by
the President from the appointed members and shall
serve as chairman for a term of two years;
(v) the ex officio members of the Board shall be
nonvoting members and shall be the Secretary, the
Director of the Office of Science and Technology
Policy, the Director of NIH, the Chief Medical Director
of the Department of Veterans Affairs, the Director of
the National Institute for Occupational Safety and
Health, the Director of the National Institute of
Environmental Health Sciences, the Secretary of Labor,
the Commissioner of the Food and Drug Administration,
the Administrator of the Environmental Protection
Agency, the Chairman of the Consumer Product Safety
Commission, the Assistant Secretary of Defense for
Health Affairs, and the Director of the Office of
Science of the Department of Energy (or the designees
of such officers); and
(vi) the Board shall meet at least four times each
fiscal year.
(B) This section applies to the advisory council to the
National Heart, Lung, and Blood Institute, except that the
advisory council shall meet at least four times each fiscal
year. \1\
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\1\ Section 407 of the Public Health Service Act was repealed by
section 104(b)(1)(C) of Public Law 109-482 (120 Stat. 3693).
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certain uses of funds
Sec. 408. [284c] (a)(1) Except as provided in paragraph
(2), the sum of the amounts obligated in any fiscal year for
administrative expenses of the National Institutes of Health
may not exceed an amount which is 5.5 percent of the total
amount appropriated for such fiscal year for the National
Institutes of Health.
(2) Paragraph (1) does not apply to the National Library of
Medicine, the National Center for Nursing Research, \1\ the
John E. Fogarty International Center for Advanced Study in the
Health Sciences, the Warren G. Magnuson Clinical Center, and
the Office of Medical Applications of Research.
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\1\ See footnote 2 for section 403(5).
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(3) For purposes of paragraph (1), the term
``administrative expenses'' means expenses incurred for the
support of activities relevant to the award of grants,
contracts, and cooperative agreements and expenses incurred for
general administration of the scientific programs and
activities of the National Institutes of Health.
(b) For fiscal year 1989 and subsequent fiscal years,
amounts made available to the National Institutes of Health
shall be available for payment of nurses and allied health
professionals in accordance with payment authorities,
scheduling options, benefits, and other authorities provided
under chapter 73 of title 38, United States Code, for nurses of
the Department of Veterans Affairs.
definitions
Sec. 409. [284d] (a) Health Service Research.--For purposes
of this title, the term ``health services research'' means
research endeavors that study the impact of the organization,
financing and management of health services on the quality,
cost, access to and outcomes of care. Such term does not
include research on the efficacy of services to prevent,
diagnose, or treat medical conditions.
(b) Clinical Research.--As used in this title, the term
``clinical research'' means patient oriented clinical research
conducted with human subjects, or research on the causes and
consequences of disease in human populations involving material
of human origin (such as tissue specimens and cognitive
phenomena) for which an investigator or colleague directly
interacts with human subjects in an outpatient or inpatient
setting to clarify a problem in human physiology,
pathophysiology or disease, or epidemiologic or behavioral
studies, outcomes research or health services research, or
developing new technologies, therapeutic interventions, or
clinical trials.
research on osteoporosis, paget's disease, and related bone disorders
Sec. 409A. [284e] (a) Establishment.--The Directors of the
National Institute of Arthritis and Musculoskeletal and Skin
Diseases, the National Institute on Aging, the National
Institute of Dental Research, \1\ and the National Institute of
Diabetes and Digestive and Kidney Diseases, shall expand and
intensify the programs of such Institutes with respect to
research and related activities concerning osteoporosis,
Paget's disease, and related bone disorders.
---------------------------------------------------------------------------
\1\See footnote for section 401(b)(1)(H).
---------------------------------------------------------------------------
(b) Coordination.--The Directors referred to in subsection
(a) shall jointly coordinate the programs referred to in such
subsection and consult with the Arthritis and Musculoskeletal
Diseases Interagency Coordinating Committee and the Interagency
Task Force on Aging Research.
(c) Information Clearinghouse.--
(1) In general.--In order to assist in carrying out
the purpose described in subsection (a), the Director
of NIH shall provide for the establishment of an
information clearinghouse on osteoporosis and related
bone disorders to facilitate and enhance knowledge and
understanding on the part of health professionals,
patients, and the public through the effective
dissemination of information.
(2) Establishment through grant or contract.--For
the purpose of carrying out paragraph (1), the Director
of NIH shall enter into a grant, cooperative agreement,
or contract with a nonprofit private entity involved in
activities regarding the prevention and control of
osteoporosis and related bone disorders.
parkinson's disease
Sec. 409B. [42 U.S.C. 284f] (a) In General.--The Director
of NIH shall establish a program for the conduct and support of
research and training with respect to Parkinson's disease
(subject to the extent of amounts appropriated to carry out
this section).
(b) Inter-Institute Coordination.--
(1) In general.--The Director of NIH shall provide
for the coordination of the program established under
subsection (a) among all of the national research
institutes conducting Parkinson's disease research.
(2) Conference.--Coordination under paragraph (1)
shall include the convening of a research planning
conference not less frequently than once every 2 years.
Each such conference shall prepare and submit to the
Committee on Appropriations and the Committee on Labor
and Human Resources of the Senate and the Committee on
Appropriations and the Committee on Commerce of the
House of Representatives a report concerning the
conference.
(c) Morris K. Udall Research Centers.--
(1) In general.--The Director of NIH is authorized
to award Core Center Grants to encourage the
development of innovative multidisciplinary research
and provide training concerning Parkinson's disease.
The Director is authorized to award not more than 10
Core Center Grants and designate each center funded
under such grants as a Morris K. Udall Center for
Research on Parkinson's Disease.
(2) Requirements.--
(A) In general.--With respect to
Parkinson's disease, each center assisted under
this subsection shall--
(i) use the facilities of a single
institution or a consortium of
cooperating institutions, and meet such
qualifications as may be prescribed by
the Director of the NIH; and
(ii) conduct basic and clinical
research.
(B) Discretionary requirements.--With
respect to Parkinson's disease, each center
assisted under this subsection may--
(i) conduct training programs for
scientists and health professionals;
(ii) conduct programs to provide
information and continuing education to
health professionals;
(iii) conduct programs for the
dissemination of information to the
public;
(iv) separately or in collaboration
with other centers, establish a
nationwide data system derived from
patient populations with Parkinson's
disease, and where possible, comparing
relevant data involving general
populations;
(v) separately or in collaboration
with other centers, establish a
Parkinson's Disease Information
Clearinghouse to facilitate and enhance
knowledge and understanding of
Parkinson's disease; and
(vi) separately or in collaboration
with other centers, establish a
national education program that fosters
a national focus on Parkinson's disease
and the care of those with Parkinson's
disease.
(3) Stipends regarding training programs.--A center
may use funds provided under paragraph (1) to provide
stipends for scientists and health professionals
enrolled in training programs under paragraph (2)(B).
(4) Duration of support.--Support of a center under
this subsection may be for a period not exceeding five
years. Such period may be extended by the Director of
NIH for one or more additional periods of not more than
five years if the operations of such center have been
reviewed by an appropriate technical and scientific
peer review group established by the Director and if
such group has recommended to the Director that such
period should be extended.
(d) Morris K. Udall Awards for Excellence in Parkinson's
Disease Research.--The Director of NIH is authorized to
establish a grant program to support investigators with a
proven record of excellence and innovation in Parkinson's
disease research and who demonstrate potential for significant
future breakthroughs in the understanding of the pathogensis,
diagnosis, and treatment of Parkinson's disease. Grants under
this subsection shall be available for a period of not to
exceed 5 years.
expansion, intensification, and coordination of activities of national
institutes of health with respect to research on autism spectrum
disorder \1\
---------------------------------------------------------------------------
\1\ Title I of Public Law 106-310 (114 Stat. 1105) established
several programs regarding autism, including the program under section
409C above. Section 105 of the Public Law requires annual reports to
the Congress on the implementation of such title I and the amendments
made by the title.
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Sec. 409C. [284g] (a) In General.--
(1) Expansion of activities.--The Director of NIH
(in this section referred to as the ``Director'')
shall, subject to the availability of appropriations,
expand, intensify, and coordinate the activities of the
National Institutes of Health with respect to research
on autism spectrum disorder, including basic and
clinical research in fields including pathology,
developmental neurobiology, genetics, epigenetics,
pharmacology, nutrition, immunology, neuroimmunology,
neurobehavioral development, endocrinology,
gastroenterology, and toxicology. Such research shall
investigate the cause (including possible environmental
causes), diagnosis or rule out, early detection,
prevention, services, supports, intervention, and
treatment of autism spectrum disorder.
(2) Consolidation.--The Director may consolidate
program activities under this section if such
consolidation would improve program efficiencies and
outcomes.
(3) Administration of program; collaboration among
agencies.--The Director shall carry out this section
acting through the Director of the National Institute
of Mental Health and in collaboration with any other
agencies that the Director determines appropriate.
(b) Centers of Excellence.--
(1) In general.--The Director shall under
subsection (a)(1) make awards of grants and contracts
to public or nonprofit private entities to pay all or
part of the cost of planning, establishing, improving,
and providing basic operating support for centers of
excellence regarding research on autism spectrum
disorder.
(2) Research.--Each center under paragraph (1)
shall conduct basic and clinical research into autism
spectrum disorder. Such research should include
investigations into the cause, diagnosis, early
detection, prevention, control, and treatment of autism
spectrum disorder. The centers, as a group, shall
conduct research including the fields of developmental
neurobiology, genetics, and psychopharmacology.
(3) Services for patients.--
(A) In general.--A center under paragraph
(1) may expend amounts provided under such
paragraph to carry out a program to make
individuals aware of opportunities to
participate as subjects in research conducted
by the centers.
(B) Referrals and costs.--A program under
subparagraph (A) may, in accordance with such
criteria as the Director may establish, provide
to the subjects described in such subparagraph,
referrals for health and other services, and
such patient care costs as are required for
research.
(C) Availability and access.--The extent to
which a center can demonstrate availability and
access to clinical services shall be considered
by the Director in decisions about awarding
grants to applicants which meet the scientific
criteria for funding under this section.
(4) Organization of centers.--Each center under
paragraph (1) shall use the facilities of a single
institution, or be formed from a consortium of
cooperating institutions, meeting such requirements as
may be prescribed by the Director.
(5) Number of centers; duration of support.--
(A) In general.--The Director shall provide
for the establishment of not less than five
centers under paragraph (1).
(B) Duration.--Support for a center
established under paragraph (1) may be provided
under this section for a period of not to
exceed 5 years. Such period may be extended for
one or more additional periods not exceeding 5
years if the operations of such center have
been reviewed by an appropriate technical and
scientific peer review group established by the
Director and if such group has recommended to
the Director that such period should be
extended.
(c) Facilitation of Research.--The Director shall under
subsection (a)(1) provide for a program under which samples of
tissues and genetic materials that are of use in research on
autism spectrum disorder are donated, collected, preserved, and
made available for such research. The program shall be carried
out in accordance with accepted scientific and medical
standards for the donation, collection, and preservation of
such samples.
(d) Public Input.--The Director shall under subsection
(a)(1) provide for means through which the public can obtain
information on the existing and planned programs and activities
of the National Institutes of Health with respect to autism
spectrum disorder and through which the Director can receive
comments from the public regarding such programs and
activities.
pediatric research initiative
Sec. 409D. [284h] (a) Establishment.--The Secretary shall
establish within the Office of the Director of NIH a Pediatric
Research Initiative (referred to in this section as the
``Initiative'') to conduct and support research that is
directly related to diseases, disorders, and other conditions
in children. The Initiative shall be headed by the Director of
NIH.
(b) Purpose.--The purpose of the Initiative is to provide
funds to enable the Director of NIH--
(1) to increase support for pediatric biomedical
research within the National Institutes of Health to
realize the expanding opportunities for advancement in
scientific investigations and care for children;
(2) to enhance collaborative efforts among the
Institutes to conduct and support multidisciplinary
research in the areas that the Director deems most
promising; and
(3) in coordination with the Food and Drug
Administration, to increase the development of adequate
pediatric clinical trials and pediatric use information
to promote the safer and more effective use of
prescription drugs in the pediatric population.
(c) Duties.--In carrying out subsection (b), the Director
of NIH shall--
(1) consult with the Director of the Eunice Kennedy
Shriver National Institute of Child Health and Human
Development and the other national research institutes,
in considering their requests for new or expanded
pediatric research efforts, and consult with the
Administrator of the Health Resources and Services
Administration and other advisors as the Director
determines to be appropriate;
(2) have broad discretion in the allocation of any
Initiative assistance among the Institutes, among types
of grants, and between basic and clinical research so
long as the assistance is directly related to the
illnesses and conditions of children; and
(3) be responsible for the oversight of any newly
appropriated Initiative funds and annually report to
Congress and the public on the extent of the total
funds obligated to conduct or support pediatric
research across the National Institutes of Health,
including the specific support and research awards
allocated through the Initiative.
(d) Transfer of Funds.--The Director of NIH may transfer
amounts appropriated under this section to any of the
Institutes for a fiscal year to carry out the purposes of the
Initiative under this section.
SEC. 409E. [284I] AUTOIMMUNE DISEASES.
(a) Expansion, Intensification, and Coordination of
Activities.--
(1) In general.--The Director of NIH shall expand,
intensify, and coordinate research and other activities
of the National Institutes of Health with respect to
autoimmune diseases.
(2) Allocations by director of nih.--With respect
to amounts appropriated to carry out this section for a
fiscal year, the Director of NIH shall allocate the
amounts among the national research institutes that are
carrying out paragraph (1).
(3) Definition.--The term ``autoimmune disease''
includes, for purposes of this section such diseases or
disorders with evidence of autoimmune pathogensis as
the Secretary determines to be appropriate.
(b) Coordinating Committee.--
(1) In general.--The Secretary shall ensure that
the Autoimmune Diseases Coordinating Committee
(referred to in this section as the ``Coordinating
Committee'') coordinates activities across the National
Institutes and with other Federal health programs and
activities relating to such diseases.
(2) Composition.--The Coordinating Committee shall
be composed of the directors or their designees of each
of the national research institutes involved in
research with respect to autoimmune diseases and
representatives of all other Federal departments and
agencies whose programs involve health functions or
responsibilities relevant to such diseases, including
the Centers for Disease Control and Prevention and the
Food and Drug Administration.
(3) Chair.--
(A) In general.--With respect to autoimmune
diseases, the Chair of the Committee shall
serve as the principal advisor to the
Secretary, the Assistant Secretary for Health,
and the Director of NIH, and shall provide
advice to the Director of the Centers for
Disease Control and Prevention, the
Commissioner of Food and Drugs, and other
relevant agencies.
(B) Director of nih.--The Chair of the
Committee shall be directly responsible to the
Director of NIH.
(c) Plan for NIH Activities.--
(1) In general.--Not later than 1 year after the
date of the enactment of this section, the Coordinating
Committee shall develop a plan for conducting and
supporting research and education on autoimmune
diseases through the national research institutes and
shall periodically review and revise the plan. The plan
shall--
(A) provide for a broad range of research
and education activities relating to
biomedical, psychosocial, and rehabilitative
issues, including studies of the
disproportionate impact of such diseases on
women;
(B) identify priorities among the programs
and activities of the National Institutes of
Health regarding such diseases; and
(C) reflect input from a broad range of
scientists, patients, and advocacy groups.
(2) Certain elements of plan.--The plan under
paragraph (1) shall, with respect to autoimmune
diseases, provide for the following as appropriate:
(A) Research to determine the reasons
underlying the incidence and prevalence of the
diseases.
(B) Basic research concerning the etiology
and causes of the diseases.
(C) Epidemiological studies to address the
frequency and natural history of the diseases,
including any differences among the sexes and
among racial and ethnic groups.
(D) The development of improved screening
techniques.
(E) Clinical research for the development
and evaluation of new treatments, including new
biological agents.
(F) Information and education programs for
health care professionals and the public.
(3) Implementation of plan.--The Director of NIH
shall ensure that programs and activities of the
National Institutes of Health regarding autoimmune
diseases are implemented in accordance with the plan
under paragraph (1).
muscular dystrophy research
Sec. 409F. [284j] (a) Coordination of Activities.--The
Director of NIH shall expand and increase coordination in the
activities of the National Institutes of Health with respect to
research on muscular dystrophies, including Duchenne muscular
dystrophy.
(b) Administration of Program; Collaboration Among
Agencies.--The Director of NIH shall carry out this section
through the appropriate institutes, including the National
Institute of Neurological Disorders and Stroke and in
collaboration with any other agencies that the Director
determines appropriate.
SEC. 409G. [284K] CLINICAL RESEARCH.
(a) In General.--The Director of National Institutes of
Health shall undertake activities to support and expand the
involvement of the National Institutes of Health in clinical
research.
(b) Requirements.--In carrying out subsection (a), the
Director of National Institutes of Health shall--
(1) consider the recommendations of the Division of
Research Grants Clinical Research Study Group and other
recommendations for enhancing clinical research; and
(2) establish intramural and extramural clinical
research fellowship programs directed specifically at
medical and dental students and a continuing education
clinical research training program at the National
Institutes of Health.
(c) Support for the Diverse Needs of Clinical Research.--
The Director of National Institutes of Health, in cooperation
with the Directors of the Institutes, Centers, and Divisions of
the National Institutes of Health, shall support and expand the
resources available for the diverse needs of the clinical
research community, including inpatient, outpatient, and
critical care clinical research.
(d) Peer Review.--The Director of National Institutes of
Health shall establish peer review mechanisms to evaluate
applications for the awards and fellowships provided for in
subsection (b)(2) and section 409D. Such review mechanisms
shall include individuals who are exceptionally qualified to
appraise the merits of potential clinical research training and
research grant proposals.
SEC. 409H. [284L] ENHANCEMENT AWARDS.
(a) Mentored Patient-Oriented Research Career Development
Awards.--
(1) Grants.--
(A) In general.--The Director of the
National Institutes of Health shall make grants
(to be referred to as ``Mentored Patient-
Oriented Research Career Development Awards'')
to support individual careers in clinical
research at general clinical research centers
or at other institutions that have the
infrastructure and resources deemed appropriate
for conducting patient-oriented clinical
research.
(B) Use.--Grants under subparagraph (A)
shall be used to support clinical investigators
in the early phases of their independent
careers by providing salary and such other
support for a period of supervised study.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(b) Mid-Career Investigator Awards in Patient-Oriented
Research.--
(1) Grants.--
(A) In general.--The Director of the
National Institutes of Health shall make grants
(to be referred to as ``Mid-Career Investigator
Awards in Patient-Oriented Research'') to
support individual clinical research projects
at general clinical research centers or at
other institutions that have the infrastructure
and resources deemed appropriate for conducting
patient-oriented clinical research.
(B) Use.--Grants under subparagraph (A)
shall be used to provide support for mid-career
level clinicians to allow such clinicians to
devote time to clinical research and to act as
mentors for beginning clinical investigators.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director requires.
(c) Graduate Training in Clinical Investigation Award.--
(1) In general.--The Director of the National
Institutes of Health shall make grants (to be referred
to as ``Graduate Training in Clinical Investigation
Awards'') to support individuals pursuing master's or
doctoral degrees in clinical investigation.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(3) Limitations.--Grants under this subsection
shall be for terms of 2 years or more and shall provide
stipend, tuition, and institutional support for
individual advanced degree programs in clinical
investigation.
(4) Definition.--As used in this subsection, the
term ``advanced degree programs in clinical
investigation'' means programs that award a master's or
Ph.D. degree in clinical investigation after 2 or more
years of training in areas such as the following:
(A) Analytical methods, biostatistics, and
study design.
(B) Principles of clinical pharmacology and
pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical
informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(d) Clinical Research Curriculum Awards.--
(1) In general.--The Director of the National
Institutes of Health shall make grants (to be referred
to as ``Clinical Research Curriculum Awards'') to
institutions for the development and support of
programs of core curricula for training clinical
investigators, including medical students. Such core
curricula may include training in areas such as the
following:
(A) Analytical methods, biostatistics, and
study design.
(B) Principles of clinical pharmacology and
pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical
informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
institution or a consortium of institutions at such
time as the Director may require. An institution may
submit only one such application.
(3) Limitations.--Grants under this subsection
shall be for terms of up to 5 years and may be
renewable.
SEC. 409I. [284M] PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. \1\
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\1\ Section 16 of Public Law 107-109 (115 Stat. 1421) requires the
Comptroller General of the United States, in consultation with the
Secretary of Health and Human Services, to submit to Congress a report
that relates to section 409I and to section 505A of the Federal Food,
Drug, and Cosmetic Act. The report is required to be submitted not
later than October 1, 2006.
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(a) List of Priority Issues in Pediatric Therapeutics.--
(1) In general.--Not later than one year after the
date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, the Secretary, acting through the
Director of the National Institutes of Health and in
consultation with the Commissioner of Food and Drugs
and experts in pediatric research, shall develop and
publish a priority list of needs in pediatric
therapeutics, including drugs, biological products, or
indications that require study. The list shall be
revised every three years.
(2) Consideration of available information.--In
developing and prioritizing the list under paragraph
(1), the Secretary shall consider--
(A) therapeutic gaps in pediatrics that may
include developmental pharmacology,
pharmacogenetic determinants of drug response,
metabolism of drugs and biologics in children,
and pediatric clinical trials;
(B) particular pediatric diseases,
disorders or conditions where more complete
knowledge and testing of therapeutics,
including drugs and biologics, may be
beneficial in pediatric populations; and
(C) the adequacy of necessary
infrastructure to conduct pediatric
pharmacological research, including research
networks and trained pediatric investigators.
(b) Pediatric Studies and Research.--The Secretary, acting
through the National Institutes of Health, shall award funds to
entities that have the expertise to conduct pediatric clinical
trials or other research (including qualified universities,
hospitals, laboratories, contract research organizations,
practice groups, federally funded programs such as pediatric
pharmacology research units, other public or private
institutions, or individuals) to enable the entities to conduct
the drug studies or other research on the issues described in
subsection (a). The Secretary may use contracts, grants, or
other appropriate funding mechanisms to award funds under this
subsection.
(c) Process for Proposed Pediatric Study Requests and
Labeling Changes.--
(1) Submission of proposed pediatric study
request.--The Director of the National Institutes of
Health shall, as appropriate, submit proposed pediatric
study requests for consideration by the Commissioner of
Food and Drugs for pediatric studies of a specific
pediatric indication identified under subsection (a).
Such a proposed pediatric study request shall be made
in a manner equivalent to a written request made under
subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act, including with respect to
the information provided on the pediatric studies to be
conducted pursuant to the request. The Director of the
National Institutes of Health may submit a proposed
pediatric study request for a drug for which--
(A)(i) there is an approved application
under section 505(j) of the Federal Food, Drug,
and Cosmetic Act; or
(ii) there is a submitted application that
could be approved under the criteria of such
section; and
(B) there is no patent protection or market
exclusivity protection for at least one form of
the drug under the Federal Food, Drug, and
Cosmetic Act; and
(C) additional studies are needed to assess
the safety and effectiveness of the use of the
drug in the pediatric population.
(2) Written request to holders of approved
applications for drugs lacking exclusivity.--The
Commissioner of Food and Drugs, in consultation with
the Director of the National Institutes of Health, may
issue a written request based on the proposed pediatric
study request for the indication or indications
submitted pursuant to paragraph (1) (which shall
include a timeframe for negotiations for an agreement)
for pediatric studies concerning a drug identified
under subsection (a) to all holders of an approved
application for the drug under section 505 of the
Federal Food, Drug, and Cosmetic Act. Such a written
request shall be made in a manner equivalent to the
manner in which a written request is made under
subsection (b) or (c) of section 505A of such Act,
including with respect to information provided on the
pediatric studies to be conducted pursuant to the
request and using appropriate formulations for each age
group for which the study is requested.
(3) Requests for proposals.--If the Commissioner of
Food and Drugs does not receive a response to a written
request issued under paragraph (2) not later than 30
days after the date on which a request was issued, the
Secretary, acting through the Director of the National
Institutes of Health and in consultation with the
Commissioner of Food and Drugs, shall publish a request
for proposals to conduct the pediatric studies
described in the written request in accordance with
subsection (b).
(4) Disqualification.--A holder that receives a
first right of refusal shall not be entitled to respond
to a request for proposals under paragraph (3).
(5) Contracts, grants, or other funding
mechanisms.--A contract, grant, or other funding may be
awarded under this section only if a proposal is
submitted to the Secretary in such form and manner, and
containing such agreements, assurances, and information
as the Secretary determines to be necessary to carry
out this section.
(6) Reporting of studies.--
(A) In general.--On completion of a
pediatric study in accordance with an award
under this section, a report concerning the
study shall be submitted to the Director of the
National Institutes of Health and the
Commissioner of Food and Drugs. The report
shall include all data generated in connection
with the study, including a written request if
issued.
(B) Availability of reports.--Each report
submitted under subparagraph (A) shall be
considered to be in the public domain (subject
to section 505A(d)(4) of the Federal Food,
Drug, and Cosmetic Act) and shall be assigned a
docket number by the Commissioner of Food and
Drugs. An interested person may submit written
comments concerning such pediatric studies to
the Commissioner of Food and Drugs, and the
written comments shall become part of the
docket file with respect to each of the drugs.
(C) Action by commissioner.--The
Commissioner of Food and Drugs shall take
appropriate action in response to the reports
submitted under subparagraph (A) in accordance
with paragraph (7).
(7) Requests for labeling change.--During the 180-
day period after the date on which a report is
submitted under paragraph (6)(A), the Commissioner of
Food and Drugs shall--
(A) review the report and such other data
as are available concerning the safe and
effective use in the pediatric population of
the drug studied;
(B) negotiate with the holders of approved
applications for the drug studied for any
labeling changes that the Commissioner of Food
and Drugs determines to be appropriate and
requests the holders to make; and
(C)(i) place in the public docket file a
copy of the report and of any requested
labeling changes; and
(ii) publish in the Federal Register and
through a posting on the Web site of the Food
and Drug Administration a summary of the report
and a copy of any requested labeling changes.
(8) Dispute resolution.--
(A) Referral to pediatric advisory
committee.--If, not later than the end of the
180-day period specified in paragraph (7), the
holder of an approved application for the drug
involved does not agree to any labeling change
requested by the Commissioner of Food and Drugs
under that paragraph, the Commissioner of Food
and Drugs shall refer the request to the
Pediatric Advisory Committee.
(B) Action by the pediatric advisory
committee.--Not later than 90 days after
receiving a referral under subparagraph (A),
the Pediatric Advisory Committee shall--
(i) review the available
information on the safe and effective
use of the drug in the pediatric
population, including study reports
submitted under this section; and
(ii) make a recommendation to the
Commissioner of Food and Drugs as to
appropriate labeling changes, if any.
(9) FDA determination.--Not later than 30 days
after receiving a recommendation from the Pediatric
Advisory Committee under paragraph (8)(B)(ii) with
respect to a drug, the Commissioner of Food and Drugs
shall consider the recommendation and, if appropriate,
make a request to the holders of approved applications
for the drug to make any labeling change that the
Commissioner of Food and Drugs determines to be
appropriate.
(10) Failure to agree.--If a holder of an approved
application for a drug, within 30 days after receiving
a request to make a labeling change under paragraph
(9), does not agree to make a requested labeling
change, the Commissioner of Food and Drugs may deem the
drug to be misbranded under the Federal Food, Drug, and
Cosmetic Act.
(11) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under the Federal Food,
Drug, and Cosmetic Act when a drug lacks appropriate
pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement
action referred to in the preceding sentence) shall
preclude, delay, or serve as the basis to stay the
other course of action.
(d) Dissemination of Pediatric Information.--Not later than
one year after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Secretary, acting
through the Director of the National Institutes of Health,
shall study the feasibility of establishing a compilation of
information on pediatric drug use and report the findings to
Congress.
(e) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this section--
(A) $200,000,000 for fiscal year 2008; and
(B) such sums as are necessary for each of
the four succeeding fiscal years.
(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.
SEC. 409J. [284Q] PAIN RESEARCH.
(a) Research Initiatives.--
(1) In general.--The Director of NIH is encouraged
to continue and expand, through the Pain Consortium, an
aggressive program of basic and clinical research on
the causes of and potential treatments for pain.
(2) Annual recommendations.--Not less than
annually, the Pain Consortium, in consultation with the
Division of Program Coordination, Planning, and
Strategic Initiatives, shall develop and submit to the
Director of NIH recommendations on appropriate pain
research initiatives that could be undertaken with
funds reserved under section 402A(c)(1) for the Common
Fund or otherwise available for such initiatives.
(3) Definition.--In this subsection, the term
``Pain Consortium'' means the Pain Consortium of the
National Institutes of Health or a similar trans-
National Institutes of Health coordinating entity
designated by the Secretary for purposes of this
subsection.
(b) Interagency Pain Research Coordinating Committee.--
(1) Establishment.--The Secretary shall establish
not later than 1 year after the date of the enactment
of this section and as necessary maintain a committee,
to be known as the Interagency Pain Research
Coordinating Committee (in this section referred to as
the ``Committee''), to coordinate all efforts within
the Department of Health and Human Services and other
Federal agencies that relate to pain research.
(2) Membership.--
(A) In general.--The Committee shall be
composed of the following voting members:
(i) Not more than 7 voting Federal
representatives appoint by the
Secretary from agencies that conduct
pain care research and treatment.
(ii) 12 additional voting members
appointed under subparagraph (B).
(B) Additional members.--The Committee
shall include additional voting members
appointed by the Secretary as follows:
(i) 6 non-Federal members shall be
appointed from among scientists,
physicians, and other health
professionals.
(ii) 6 members shall be appointed
from members of the general public, who
are representatives of leading
research, advocacy, and service
organizations for individuals with
pain-related conditions.
(C) Nonvoting members.--The Committee shall
include such nonvoting members as the Secretary
determines to be appropriate.
(3) Chairperson.--The voting members of the
Committee shall select a chairperson from among such
members. The selection of a chairperson shall be
subject to the approval of the Director of NIH.
(4) Meetings.--The Committee shall meet at the call
of the chairperson of the Committee or upon the request
of the Director of NIH, but in no case less often than
once each year.
(5) Duties.--The Committee shall--
(A) develop a summary of advances in pain
care research supported or conducted by the
Federal agencies relevant to the diagnosis,
prevention, and treatment of pain and diseases
and disorders associated with pain;
(B) identify critical gaps in basic and
clinical research on the symptoms and causes of
pain;
(C) make recommendations to ensure that the
activities of the National Institutes of Health
and other Federal agencies are free of
unnecessary duplication of effort;
(D) make recommendations on how best to
disseminate information on pain care; and
(E) make recommendations on how to expand
partnerships between public entities and
private entities to expand collaborative,
cross-cutting research.
(6) Review.--The Secretary shall review the
necessity of the Committee at least once every 2 years.
Part C--Specific Provisions Respecting National Research Institutes
Subpart 1--National Cancer Institute
purpose of institute
Sec. 410. [285] The general purpose of the National Cancer
Institute (hereafter in this subpart referred to as the
``Institute'') is the conduct and support of research,
training, health information dissemination, and other programs
with respect to the cause, diagnosis, prevention, and treatment
of cancer, rehabilitation from cancer, and the continuing care
of cancer patients and the families of cancer patients.
national cancer program
Sec. 411. [285a] The National Cancer Program shall consist
of (1) an expanded, intensified, and coordinated cancer
research program encompassing the research programs conducted
and supported by the Institute and the related research
programs of the other national research institutes, including
an expanded and intensified research program for the prevention
of cancer caused by occupational or environmental exposure to
carcinogens, and (2) the other programs and activities of the
Institute.
cancer control programs
Sec. 412. [285a-1] The Director of the Institute shall
establish and support demonstration, education, and other
programs for the detection, diagnosis, prevention, and
treatment of cancer and for rehabilitation and counseling
respecting cancer. Programs established and supported under
this section shall include--
(1) locally initiated education and demonstration
programs (and regional networks of such programs) to
transmit research results and to disseminate
information respecting--
(A) the detection, diagnosis, prevention,
and treatment of cancer,
(B) the continuing care of cancer patients
and the families of cancer patients, and
(C) rehabilitation and counseling
respecting cancer,
to physicians and other health professionals who
provide care to individuals who have cancer;
(2) the demonstration of and the education of
students of the health professions and health
professionals in--
(A) effective methods for the prevention
and early detection of cancer and the
identification of individuals with a high risk
of developing cancer, and
(B) improved methods of patient referral to
appropriate centers for early diagnosis and
treatment of cancer; and
(3) the demonstration of new methods for the
dissemination of information to the general public
concerning the prevention, early detection, diagnosis,
and treatment and control of cancer and information
concerning unapproved and ineffective methods, drugs,
and devices for the diagnosis, prevention, treatment,
and control of cancer.
special authorities of the director
Sec. 413. [285a-2] (a)(1) The Director of the Institute
shall establish an information and education program to
collect, identify, analyze, and disseminate on a timely basis,
through publications and other appropriate means, to cancer
patients and their families, physicians and other health
professionals, and the general public, information on cancer
research, diagnosis, prevention, and treatment (including
information respecting nutrition programs for cancer patients
and the relationship between nutrition and cancer). The
Director of the Institute may take such action as may be
necessary to insure that all channels for the dissemination and
exchange of scientific knowledge and information are maintained
between the Institute and the public and between the Institute
and other scientific, medical, and biomedical disciplines and
organizations nationally and internationally.
(2) In carrying out paragraph (1), the Director of the
Institute shall--
(A) provide public and patient information and
education programs, providing information that will
help individuals take personal steps to reduce their
risk of cancer, to make them aware of early detection
techniques and to motivate appropriate utilization of
those techniques, to help individuals deal with cancer
if it strikes, and to provide information to improve
long-term survival;
(B) continue and expand programs to provide
physicians and the public with state-of-the-art
information on the treatment of particular forms of
cancers, and to identify those clinical trials that
might benefit patients while advancing knowledge of
cancer treatment;
(C) assess the incorporation of state-of-the-art
cancer treatments into clinical practice and the extent
to which cancer patients receive such treatments and
include the results of such assessments in the biennial
reports required under section 407;
(D) maintain and operate the International Cancer
Research Data Bank, which shall collect, catalog,
store, and disseminate insofar as feasible the results
of cancer research and treatment undertaken in any
country for the use of any person involved in cancer
research and treatment in any country; and
(E) to the extent practicable, in disseminating the
results of such cancer research and treatment, utilize
information systems available to the public.
(b) The Director of the Institute in carrying out the
National Cancer Program--
(1) shall establish or support the large-scale
production or distribution of specialized biological
materials and other therapeutic substances for cancer
research and set standards of safety and care for
persons using such materials;
(2) shall, in consultation with the advisory
council for the Institute, support (A) research in the
cancer field outside the United States by highly
qualified foreign nationals which can be expected to
benefit the American people, (B) collaborative research
involving American and foreign participants, and (C)
the training of American scientists abroad and foreign
scientists in the United States;
(3) shall, in consultation with the advisory
council for the Institute, support appropriate programs
of education and training (including continuing
education and laboratory and clinical research
training);
(4) shall encourage and coordinate cancer research
by industrial concerns where such concerns evidence a
particular capability for such research;
(5) may obtain (after consultation with the
advisory council for the Institute and in accordance
with section 3109 of title 5, United States Code, but
without regard to the limitation in such section on the
period of service) the services of not more than one
hundred and fifty-one experts or consultants who have
scientific or professional qualifications;
(6)(A) may, in consultation with the advisory
council for the Institute, acquire, construct, improve,
repair, operate, and maintain laboratories, other
research facilities, equipment, and such other real or
personal property as the Director determines necessary;
(B) may, in consultation with the advisory council
for the Institute, make grants for construction or
renovation of facilities; and
(C) may, in consultation with the advisory council
for the Institute, acquire, without regard to the Act
of March 3, 1877 (40 U.S.C. 34), by lease or otherwise
through the Administrator of General Services,
buildings or parts of buildings in the District of
Columbia or communities located adjacent to the
District of Columbia for the use of the Institute for a
period not to exceed ten years;
(7) may, in consultation with the advisory council
for the Institute, appoint one or more advisory
committees composed of such private citizens and
officials of Federal, State, and local governments to
advise the Director with respect to the Director's
functions;
(8) may, subject to section 405(b)(2) and without
regard to section 3324 of title 31, United States Code,
and section 3709 of the Revised Statutes (41 U.S.C. 5),
enter into such contracts, leases, cooperative
agreements, as may be necessary in the conduct of
functions of the Director, with any public agency, or
with any person, firm, association, corporation, or
educational institution; and
(9) shall, notwithstanding section 405(a), prepare
and submit, directly to the President for review and
transmittal to Congress, an annual budget estimate
(including an estimate of the number and type of
personnel needs for the Institute) for the National
Cancer Program, after reasonable opportunity for
comment (but without change) by the Secretary, the
Director of NIH, and the Institute's advisory council.
Except as otherwise provided, experts and consultants whose
services are obtained under paragraph (5) shall be paid or
reimbursed, in accordance with title 5, United States Code, for
their travel to and from their place of service and for other
expenses associated with their assignment. Such expenses shall
not be allowed in connection with the assignment of an expert
or consultant whose services are obtained under paragraph (5)
unless the expert or consultant has agreed in writing to
complete the entire period of the assignment or one year of the
assignment, whichever is shorter, unless separated or
reassigned for reasons which are beyond the control of the
expert or consultant and which are acceptable to the Director
of the Institute. If the expert or consultant violates the
agreement, the money spent by the United States for such
expenses is recoverable from the expert or consultant as a debt
due the United States. The Secretary may waive in whole or in
part a right of recovery under the preceding sentence.
(c) Pre-Clinical Models To Evaluate Promising Pediatric
Cancer Therapies.--
(1) Expansion and coordination of activities.--The
Director of the National Cancer Institute shall expand,
intensify, and coordinate the activities of the
Institute with respect to research on the development
of preclinical models to evaluate which therapies are
likely to be effective for treating pediatric cancer.
(2) Coordination with other institutes.--The
Director of the Institute shall coordinate the
activities under paragraph (1) with similar activities
conducted by other national research institutes and
agencies of the National Institutes of Health to the
extent that those Institutes and agencies have
responsibilities that are related to pediatric cancer.
national cancer research and demonstration centers
Sec. 414. [285a-3] (a)(1) The Director of the Institute may
enter into cooperative agreements with and make grants to
public or private nonprofit entities to pay all or part of the
cost of planning, establishing, or strengthening, and providing
basic operating support for centers for basic and clinical
research into, training in, and demonstration of advanced
diagnostic, prevention, control, and treatment methods for
cancer.
(2) A cooperative agreement or grant under paragraph (1)
shall be entered into in accordance with policies established
by the Director of NIH and after consultation with the
Institute's advisory council.
(b) Federal payments made under a cooperative agreement or
grant under subsection (a) may be used for--
(1) construction (notwithstanding any limitation
under section 496);
(2) staffing and other basic operating costs,
including such patient care costs as are required for
research;
(3) clinical training, including training for
allied health professionals, continuing education for
health professionals and allied health professions
personnel, and information programs for the public
respecting cancer; and
(4) demonstration purposes.
As used in this paragraph, the term ``construction'' does not
include the acquisition of land, and the term ``training'' does
not include research training for which National Research
Service Awards \1\ may be provided under section 487.
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\1\ Now Ruth L. Kirschstein National Research Service Awards. See
section 487.
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(c) Support of a center under subsection (a) may be for a
period of not to exceed five years. Such period may be extended
by the Director for additional periods of not more than five
years each if the operations of such center have been reviewed
by an appropriate technical and scientific peer review group
established by the Director and if such group has recommended
to the Director that such period should be extended.
(d) Research centers under this section may not be
considered centers of excellence for purposes of section
402(b)(10).
president's cancer panel
Sec. 415. [285a-4] (a)(1) The President's Cancer Panel
(hereafter in this section referred to as the ``Panel'') shall
be composed of three persons appointed by the President who by
virtue of their training, experience, and background are
exceptionally qualified to appraise the National Cancer
Program. At least two members of the Panel shall be
distinguished scientists or physicians.
(2)(A) Members of the Panel shall be appointed for three-
year terms, except that (i) any member appointed to fill a
vacancy occurring prior to the expiration of the term for which
the member's predecessor was appointed shall be appointed only
for the remainder of such term, and (ii) a member may serve
until the member's successor has taken office. If a vacancy
occurs in the Panel, the President shall make an appointment to
fill the vacancy not later than 90 days after the date the
vacancy occurred.
(B) The President shall designate one of the members to
serve as the chairman of the Panel for a term of one year.
(C) Members of the Panel shall each be entitled to receive
the daily equivalent of the annual rate of basic pay in effect
for grade GS-18 of the General Schedule for each day (including
traveltime) during which they are engaged in the actual
performance of duties as members of the Panel and shall be paid
or reimbursed, in accordance with title 5, United States Code,
for their travel to and from their place of service and for
other expenses associated with their assignment.
(3) The Panel shall meet at the call of the chairman, but
not less often than four times a year. A transcript shall be
kept of the proceedings of each meeting of the Panel, and the
chairman shall make such transcript available to the public.
(b) The Panel shall monitor the development and execution
of the activities of the National Cancer Program, and shall
report directly to the President. Any delays or blockages in
rapid execution of the Program shall immediately be brought to
the attention of the President. The Panel shall submit to the
President periodic progress reports on the National Cancer
Program and shall submit to the President, the Secretary, and
the Congress an annual evaluation of the efficacy of the
Program and suggestions for improvements, and shall submit such
other reports as the President shall direct.
associate director for prevention
Sec. 416. [285a-5] (a) There shall be in the Institute an
Associate Director for Prevention to coordinate and promote the
programs in the Institute concerning the prevention of cancer.
The Associate Director shall be appointed by the Director of
the Institute from individuals who because of their
professional training or experience are experts in public
health or preventive medicine.
(b) The Associate Director for Prevention shall prepare for
inclusion in the biennial report made under section 407 a
description of the prevention activities of the Institute,
including a description of the staff and resources allocated to
those activities.
breast and gynecological cancers
Sec. 417. [285a-6] (a) Expansion and Coordination of
Activities.--The Director of the Institute, in consultation
with the National Cancer Advisory Board, shall expand,
intensify, and coordinate the activities of the Institute with
respect to research on breast cancer, ovarian cancer, and other
cancers of the reproductive system of women.
(b) Coordination With Other Institutes.--The Director of
the Institute shall coordinate the activities of the Director
under subsection (a) with similar activities conducted by other
national research institutes and agencies of the National
Institutes of Health to the extent that such Institutes and
agencies have responsibilities that are related to breast
cancer and other cancers of the reproductive system of women.
(c) Programs for Breast Cancer.--
(1) In general.--In carrying out subsection (a),
the Director of the Institute shall conduct or support
research to expand the understanding of the cause of,
and to find a cure for, breast cancer. Activities under
such subsection shall provide for an expansion and
intensification of the conduct and support of--
(A) basic research concerning the etiology
and causes of breast cancer;
(B) clinical research and related
activities concerning the causes, prevention,
detection and treatment of breast cancer;
(C) control programs with respect to breast
cancer in accordance with section 412,
including community-based programs designed to
assist women who are members of medically
underserved populations, low-income
populations, or minority groups;
(D) information and education programs with
respect to breast cancer in accordance with
section 413; and
(E) research and demonstration centers with
respect to breast cancer in accordance with
section 414, including the development and
operation of centers for breast cancer research
to bring together basic and clinical,
biomedical and behavioral scientists to conduct
basic, clinical, epidemiological, psychosocial,
prevention and treatment research and related
activities on breast cancer.
Not less than six centers shall be operated under
subparagraph (E). Activities of such centers should
include supporting new and innovative research and
training programs for new researchers. Such centers
shall give priority to expediting the transfer of
research advances to clinical applications.
(2) Implementation of plan for programs.--
(A) The Director of the Institute shall
ensure that the research programs described in
paragraph (1) are implemented in accordance
with a plan for the programs. Such plan shall
include comments and recommendations that the
Director of the Institute considers
appropriate, with due consideration provided to
the professional judgment needs of the
Institute as expressed in the annual budget
estimate prepared in accordance with section
413(9) \1\. The Director of the Institute, in
consultation with the National Cancer Advisory
Board, shall periodically review and revise
such plan.
---------------------------------------------------------------------------
\1\ So in law. See section 401 of Public Law 103-43 (107 Stat.
153). Probably should be section ``413(b)(9)''.
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(B) Not later than October 1, 1993, the
Director of the Institute shall submit a copy
of the plan to the President's Cancer Panel,
the Secretary and the Director of NIH.
(C) The Director of the Institute shall
submit any revisions of the plan to the
President's Cancer Panel, the Secretary, and
the Director of NIH.
(D) The Secretary shall provide a copy of
the plan submitted under subparagraph (A), and
any revisions submitted under subparagraph (C),
to the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate.
(d) Other Cancers.--In carrying out subsection (a), the
Director of the Institute shall conduct or support research on
ovarian cancer and other cancers of the reproductive system of
women. Activities under such subsection shall provide for the
conduct and support of--
(1) basic research concerning the etiology and
causes of ovarian cancer and other cancers of the
reproductive system of women;
(2) clinical research and related activities into
the causes, prevention, detection and treatment of
ovarian cancer and other cancers of the reproductive
system of women;
(3) control programs with respect to ovarian cancer
and other cancers of the reproductive system of women
in accordance with section 412;
(4) information and education programs with respect
to ovarian cancer and other cancers of the reproductive
system of women in accordance with section 413; and
(5) research and demonstration centers with respect
to ovarian cancer and cancers of the reproductive
system in accordance with section 414.
(e) Report.--The Director of the Institute shall prepare,
for inclusion in the biennial report submitted under section
407, a report that describes the activities of the National
Cancer Institute under the research programs referred to in
subsection (a), that shall include--
(1) a description of the research plan with respect
to breast cancer prepared under subsection (c);
(2) an assessment of the development, revision, and
implementation of such plan;
(3) a description and evaluation of the progress
made, during the period for which such report is
prepared, in the research programs on breast cancer and
cancers of the reproductive system of women;
(4) a summary and analysis of expenditures made,
during the period for which such report is made, for
activities with respect to breast cancer and cancers of
the reproductive system of women conducted and
supported by the National Institutes of Health; and
(5) such comments and recommendations as the
Director considers appropriate.
prostate cancer
Sec. 417A. [285a-7] (a) Expansion and Coordination of
Activities.--The Director of the Institute, in consultation
with the National Cancer Advisory Board, shall expand,
intensify, and coordinate the activities of the Institute with
respect to research on prostate cancer.
(b) Coordination With Other Institutes.--The Director of
the Institute shall coordinate the activities of the Director
under subsection (a) with similar activities conducted by other
national research institutes and agencies of the National
Institutes of Health to the extent that such Institutes and
agencies have responsibilities that are related to prostate
cancer.
(c) Programs.--
(1) In general.--In carrying out subsection (a),
the Director of the Institute shall conduct or support
research to expand the understanding of the cause of,
and to find a cure for, prostate cancer. Activities
under such subsection shall provide for an expansion
and intensification of the conduct and support of--
(A) basic research concerning the etiology
and causes of prostate cancer;
(B) clinical research and related
activities concerning the causes, prevention,
detection and treatment of prostate cancer;
(C) prevention and control and early
detection programs with respect to prostate
cancer in accordance with section 412,
particularly as it relates to intensifying
research on the role of prostate specific
antigen for the screening and early detection
of prostate cancer;
(D) an Inter-Institute Task Force, under
the direction of the Director of the Institute,
to provide coordination between relevant
National Institutes of Health components of
research efforts on prostate cancer;
(E) control programs with respect to
prostate cancer in accordance with section 412;
(F) information and education programs with
respect to prostate cancer in accordance with
section 413; and
(G) research and demonstration centers with
respect to prostate cancer in accordance with
section 414, including the development and
operation of centers for prostate cancer
research to bring together basic and clinical,
biomedical and behavioral scientists to conduct
basic, clinical, epidemiological, psychosocial,
prevention and control, treatment, research,
and related activities on prostate cancer.
Not less than six centers shall be operated under
subparagraph (G). Activities of such centers should
include supporting new and innovative research and
training programs for new researchers. Such centers
shall give priority to expediting the transfer of
research advances to clinical applications.
(2) Implementation of plan for programs.--
(A) The Director of the Institute shall
ensure that the research programs described in
paragraph (1) are implemented in accordance
with a plan for the programs. Such plan shall
include comments and recommendations that the
Director of the Institute considers
appropriate, with due consideration provided to
the professional judgment needs of the
Institute as expressed in the annual budget
estimate prepared in accordance with section
413(9) \1\. The Director of the Institute, in
consultation with the National Cancer Advisory
Board, shall periodically review and revise
such plan.
---------------------------------------------------------------------------
\1\ So in law. See section 402 of Public Law 103-43 (107 Stat.
155). Probably should be ``section 413(b)(9)''.
---------------------------------------------------------------------------
(B) Not later than October 1, 1993, the
Director of the Institute shall submit a copy
of the plan to the President's Cancer Panel,
the Secretary, and the Director of NIH.
(C) The Director of the Institute shall
submit any revisions of the plan to the
President's Cancer Panel, the Secretary, and
the Director of NIH.
(D) The Secretary shall provide a copy of
the plan submitted under subparagraph (A), and
any revisions submitted under subparagraph (C),
to the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate. \1\
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\1\ Section 417B was repealed by section 103(b)(15) of Public Law
109-482 (120 Stat. 3687).
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SEC. 417C. [285A-9] GRANTS FOR EDUCATION, PREVENTION, AND EARLY
DETECTION OF RADIOGENIC CANCERS AND DISEASES.
(a) Definition.--In this section the term ``entity'' means
any--
(1) National Cancer Institute-designated cancer
center;
(2) Department of Veterans Affairs hospital or
medical center;
(3) Federally Qualified Health Center, community
health center, or hospital;
(4) agency of any State or local government,
including any State department of health; or
(5) nonprofit organization.
(b) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration in consultation with the Director of the
National Institutes of Health and the Director of the Indian
Health Service, may make competitive grants to any entity for
the purpose of carrying out programs to--
(1) screen individuals described under section
4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure
Compensation Act (42 U.S.C. 2210 note) for cancer as a
preventative health measure;
(2) provide appropriate referrals for medical
treatment of individuals screened under paragraph (1)
and to ensure, to the extent practicable, the provision
of appropriate follow-up services;
(3) develop and disseminate public information and
education programs for the detection, prevention, and
treatment of radiogenic cancers and diseases; and
(4) facilitate putative applicants in the
documentation of claims as described in section 5(a) of
the Radiation Exposure Compensation Act (42 U.S.C. 2210
note).
(c) Indian Health Service.--The programs under subsection
(a) shall include programs provided through the Indian Health
Service or through tribal contracts, compacts, grants, or
cooperative agreements with the Indian Health Service and which
are determined appropriate to raising the health status of
Indians.
(d) Grant and Contract Authority.--Entities receiving a
grant under subsection (b) may expend the grant to carry out
the purpose described in such subsection.
(e) Health Coverage Unaffected.--Nothing in this section
shall be construed to affect any coverage obligation of a
governmental or private health plan or program relating to an
individual referred to under subsection (b)(1).
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SEC. 417D. [285A-10] RESEARCH, INFORMATION, AND EDUCATION WITH RESPECT
TO BLOOD CANCER. \1\
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\1\ Section 417D (as amended by Public Law 109-482) is shown after
section 417C for the convenience of the reader. Section 3 of Public Law
107-172 (116 Stat. 541) attempts to amend this part by inserting a new
section 417D ``after section 419C''. The amendment cannot be executed,
as this part does not contain a section 419C.
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(a) Joe Moakley Research Excellence Program.--
(1) In general.--The Director of NIH shall expand,
intensify, and coordinate programs for the conduct and
support of research with respect to blood cancer, and
particularly with respect to leukemia, lymphoma, and
multiple myeloma.
(2) Administration.--The Director of NIH shall
carry out this subsection through the Director of the
National Cancer Institute and in collaboration with any
other agencies that the Director determines to be
appropriate.
(b) Geraldine Ferraro Cancer Education Program.--
(1) In general.--The Secretary shall direct the
appropriate agency within the Department of Health and
Human Services, in collaboration with the Director of
NIH, to establish and carry out a program to provide
information and education for patients and the general
public with respect to blood cancer, and particularly
with respect to the treatment of leukemia, lymphoma,
and multiple myeloma.
(2) Administration.--The Agency determined by the
Secretary under paragraph (1) shall carry out this
subsection in collaboration with private health
organizations that have national education and patient
assistance programs on blood-related cancers.
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SEC. 417E. [285A-11] PEDIATRIC CANCER RESEARCH AND AWARENESS.
(a) Pediatric Cancer Research.--
(1) Programs of research excellence in pediatric
cancer.--The Secretary, in collaboration with the
Director of NIH and other Federal agencies with
interest in prevention and treatment of pediatric
cancer, shall continue to enhance, expand, and
intensify pediatric cancer research and other
activities related to pediatric cancer, including
therapeutically applicable research to generate
effective treatments, pediatric preclinical testing,
and pediatric clinical trials through National Cancer
Institute-supported pediatric cancer clinical trial
groups and their member institutions. In enhancing,
expanding, and intensifying such research and other
activities, the Secretary is encouraged to take into
consideration the application of such research and
other activities for minority, health disparity, and
medically underserved communities. For purposes of this
section, the term ``pediatric cancer research'' means
research on the causes, prevention, diagnosis,
recognition, treatment, and long-term effects of
pediatric cancer.
(2) Peer review requirements.--All grants awarded
under this subsection shall be awarded in accordance
with section 492.
(b) Public Awareness of Pediatric Cancers and Available
Treatments and Research.--
(1) In general.--The Secretary may award grants to
childhood cancer professional and direct service
organizations for the expansion and widespread
implementation of--
(A) activities that provide available
information on treatment protocols to ensure
early access to the best available therapies
and clinical trials for pediatric cancers;
(B) activities that provide available
information on the late effects of pediatric
cancer treatment to ensure access to necessary
long-term medical and psychological care; and
(C) direct resource services such as
educational outreach for parents, peer-to-peer
and parent-to-parent support networks,
information on school re-entry and
postsecondary education, and resource
directories or referral services for financial
assistance, psychological counseling, and other
support services.
In awarding grants under this paragraph, the Secretary
is encouraged to take into consideration the extent to
which an entity would use such grant for purposes of
making activities and services described in this
paragraph available to minority, health disparity, and
medically underserved communities.
(2) Performance measurement, transparency, and
accountability.--For each grant awarded under this
subsection, the Secretary shall develop and implement
metrics-based performance measures to assess the
effectiveness of activities funded under such grant.
(3) Informational requirements.--Any information
made available pursuant to a grant awarded under
paragraph (1) shall be--
(A) culturally and linguistically
appropriate as needed by patients and families
affected by childhood cancer; and
(B) approved by the Secretary.
(c) Rule of Construction.--Nothing in this section shall be
construed as being inconsistent with the goals and purposes of
the Minority Health and Health Disparities Research and
Education Act of 2000 (42 U.S.C. 202 note) \1\.
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\1\ The patenthetical reference to 42 U.S.C. 202 note in subsection
(c) probably should be stricken or revised to refer to 42 U.S.C. 201
note.
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(d) Authorization of Appropriations.--For purposes of
carrying out this section and section 399E-1, there are
authorized to be appropriated $30,000,000 for each of fiscal
years 2009 through 2013. Such authorization of appropriations
is in addition to the authorization of appropriations
established in section 402A with respect to such purpose. Funds
appropriated under this subsection shall remain available until
expended.
SEC. 417F. [42 U.S.C. 285A-12] INTERAGENCY BREAST CANCER AND
ENVIRONMENTAL RESEARCH COORDINATING COMMITTEE.
(a) Interagency Breast Cancer and Environmental Research
Coordinating Committee.--
(1) Establishment.--Not later than 6 months after
the date of the enactment of this section, the
Secretary shall establish a committee, to be known as
the Interagency Breast Cancer and Environmental
Research Coordinating Committee (in this section
referred to as the ``Committee'').
(2) Duties.--The Committee shall--
(A) share and coordinate information on
existing research activities, and make
recommendations to the National Institutes of
Health and other Federal agencies regarding how
to improve existing research programs, that are
related to breast cancer research;
(B) develop a comprehensive strategy and
advise the National Institutes of Health and
other Federal agencies in the solicitation of
proposals for collaborative, multidisciplinary
research, including proposals to evaluate
environmental and genomic factors that may be
related to the etiology of breast cancer that
would--
(i) result in innovative approaches
to study emerging scientific
opportunities or eliminate knowledge
gaps in research to improve the
research portfolio;
(ii) outline key research
questions, methodologies, and knowledge
gaps;
(iii) expand the number of research
proposals that involve collaboration
between 2 or more national research
institutes or national centers,
including proposals for Common Fund
research described in section 402(b)(7)
to improve the research portfolio; and
(iv) expand the number of
collaborative, multidisciplinary, and
multi-institutional research grants;
(C) develop a summary of advances in breast
cancer research supported or conducted by
Federal agencies relevant to the diagnosis,
prevention, and treatment of cancer and other
diseases and disorders; and
(D) not later than 2 years after the date
of the establishment of the Committee, make
recommendations to the Secretary--
(i) regarding any appropriate
changes to research activities,
including recommendations to improve
the research portfolio of the National
Institutes of Health to ensure that
scientifically-based strategic planning
is implemented in support of research
priorities that impact breast cancer
research activities;
(ii) to ensure that the activities
of the National Institutes of Health
and other Federal agencies, including
the Department of Defense, are free of
unnecessary duplication of effort;
(iii) regarding public
participation in decisions relating to
breast cancer research to increase the
involvement of patient advocacy and
community organizations representing a
broad geographical area;
(iv) on how best to disseminate
information on breast cancer research
progress; and
(v) on how to expand partnerships
between public entities, including
Federal agencies, and private entities
to expand collaborative, cross-cutting
research.
(3) Rule of construction.--For the purposes of the
Committee, when focusing on research to evaluate
environmental and genomic factors that may be related
to the etiology of breast cancer, nothing in this
section shall be construed to restrict the Secretary
from including other forms of cancer, as appropriate,
when doing so may advance research in breast cancer or
advance research in other forms of cancer.
(4) Membership.--
(A) In general.--The Committee shall be
composed of the following voting members:
(i) Not more than 7 voting Federal
representatives as follows:
(I) The Director of the
Centers for Disease Control and
Prevention.
(II) The Director of the
National Institutes of Health
and the directors of such
national research institutes
and national centers (which may
include the National Institute
of Environmental Health
Sciences) as the Secretary
determines appropriate.
(III) One representative
from the National Cancer
Institute Board of Scientific
Advisors, appointed by the
Director of the National Cancer
Institute.
(IV) The heads of such
other agencies of the
Department of Health and Human
Services as the Secretary
determines appropriate.
(V) Representatives of
other Federal agencies that
conduct or support cancer
research, including the
Department of Defense.
(ii) 12 additional voting members
appointed under subparagraph (B).
(B) Additional members.--The Committee
shall include additional voting members
appointed by the Secretary as follows:
(i) 6 members shall be appointed
from among scientists, physicians, and
other health professionals, who--
(I) are not officers or
employees of the United States;
(II) represent multiple
disciplines, including
clinical, basic, and public
health sciences;
(III) represent different
geographical regions of the
United States;
(IV) are from practice
settings, academia, or other
research settings; and
(V) are experienced in
scientific peer review process.
(ii) 6 members shall be appointed
from members of the general public, who
represent individuals with breast
cancer.
(C) Nonvoting members.--The Committee shall
include such nonvoting members as the Secretary
determines to be appropriate.
(5) Chairperson.--The voting members of the
Committee shall select a chairperson from among such
members. The selection of a chairperson shall be
subject to the approval of the Director of NIH.
(6) Meetings.--The Committee shall meet at the call
of the chairperson of the Committee or upon the request
of the Director of NIH, but in no case less often than
once each year.
(b) Review.--The Secretary shall review the necessity of
the Committee in calendar year 2011 and, thereafter, at least
once every 2 years.
Subpart 2--National Heart, Lung, and Blood Institute
PURPOSE OF THE INSTITUTE
Sec. 418. [285b] The general purpose of the National Heart,
Lung, and Blood Institute (hereafter in this subpart referred
to as the ``Institute'') is the conduct and support of
research, training, health information dissemination, and other
programs with respect to heart, blood vessel, lung, and blood
diseases and with respect to the use of blood and blood
products and the management of blood resources.
HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND CONTROL
PROGRAMS
Sec. 419. [285b-1] (a) The Director of the Institute shall
conduct and support programs for the prevention and control of
heart, blood vessel, lung, and blood diseases. Such programs
shall include community-based and population-based programs
carried out in cooperation with other Federal agencies, with
public health agencies of State or local governments, with
nonprofit private entities that are community-based health
agencies, or with other appropriate public or nonprofit private
entities.
(b) In carrying out programs under subsection (a), the
Director of the Institute shall give special consideration to
the prevention and control of heart, blood vessel, lung, and
blood diseases in children, and in populations that are at
increased risk with respect to such diseases.
INFORMATION AND EDUCATION
Sec. 420. [285b-2] The Director of the Institute shall
collect, identify, analyze, and disseminate on a timely basis,
through publications and other appropriate means, to patients,
families of patients, physicians and other health
professionals, and the general public, information on research,
prevention, diagnosis, and treatment of heart, blood vessel,
lung, and blood diseases, the maintenance of health to reduce
the incidence of such diseases, and on the use of blood and
blood products and the management of blood resources. In
carrying out this section, the Director of the Institute shall
place special emphasis upon the utilization of collaborative
efforts with both the public and private sectors to--
(1) increase the awareness and knowledge of health
care professionals and the public regarding the
prevention of heart and blood vessel, lung, and blood
diseases and the utilization of blood resources; and
(2) develop and disseminate to health
professionals, patients and patient families, and the
public information designed to encourage adults and
children to adopt healthful practices concerning the
prevention of such diseases.
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD
RESOURCES PROGRAM
Sec. 421. [285b-3] (a)(1) The National Heart, Blood Vessel,
Lung, and Blood Diseases and Blood Resources Program (hereafter
in this subpart referred to as the ``Program'' may provide
for--
(A) investigation into the epidemiology, etiology,
and prevention of all forms and aspects of heart, blood
vessel, lung, and blood diseases, including
investigations into the social, environmental,
behavioral, nutritional, biological, and genetic
determinants and influences involved in the
epidemiology, etiology, and prevention of such
diseases;
(B) studies and research into the basic biological
processes and mechanisms involved in the underlying
normal and abnormal heart, blood vessel, lung, and
blood phenomena;
(C) research into the development, trial, and
evaluation of techniques, drugs, and devices (including
computers) used in, and approaches to, the diagnosis,
treatment (including the provision of emergency medical
services), and prevention of heart, blood vessel, lung,
and blood diseases and the rehabilitation of patients
suffering from such diseases;
(D) establishment of programs that will focus and
apply scientific and technological efforts involving
the biological, physical, and engineering sciences to
all facets of heart, blood vessel, lung, and blood
diseases with emphasis on the refinement, development,
and evaluation of technological devices that will
assist, replace, or monitor vital organs and improve
instrumentation for detection, diagnosis, and treatment
of and rehabilitation from such diseases;
(E) establishment of programs for the conduct and
direction of field studies, large-scale testing and
evaluation, and demonstration of preventive,
diagnostic, therapeutic, and rehabilitative approaches
to, and emergency medical services for, such diseases;
(F) studies and research into blood diseases and
blood, and into the use of blood for clinical purposes
and all aspects of the management of blood resources in
the United States, including the collection,
preservation, fractionation, and distribution of blood
and blood products;
(G) the education (including continuing education)
and training of scientists, clinical investigators, and
educators, in fields and specialties (including
computer sciences) requisite to the conduct of clinical
programs respecting heart, blood vessel, lung, and
blood diseases and blood resources;
(H) public and professional education relating to
all aspects of such diseases, including the prevention
of such diseases, and the use of blood and blood
products and the management of blood resources;
(I) establishment of programs for study and
research into heart, blood vessel, lung, and blood
diseases of children (including cystic fibrosis,
hyaline membrane, hemolytic diseases such as sickle
cell anemia and Cooley's anemia, and hemophilic
diseases) and for the development and demonstration of
diagnostic, treatment, and preventive approaches to
such diseases; and
(J) establishment of programs for study, research,
development, demonstrations and evaluation of emergency
medical services for people who become critically ill
in connection with heart, blood vessel, lung, or blood
diseases.
(2) The Program shall be coordinated with other national
research institutes to the extent that they have
responsibilities respecting such diseases and shall give
special emphasis to the continued development in the Institute
of programs related to the causes of stroke and to effective
coordination of such programs with related stroke programs in
the National Institute of Neurological and Communicative
Disorders and Stroke. The Director of the Institute, with the
advice of the advisory council for the Institute, shall revise
annually the plan for the Program and shall carry out the
Program in accordance with such plan.
(b) In carrying out the Program, the Director of the
Institute, under policies established by the Director of NIH--
(1) may, after consultation with the advisory
council for the Institute, obtain (in accordance with
section 3109 of title 5, United States Code, but
without regard to the limitation in such section on the
period of such service) the services of not more than
one hundred experts or consultants who have scientific
or professional qualifications;
(2)(A) may, in consultation with the advisory
council for the Institute, acquire and construct,
improve, repair, operate, alter, renovate, and
maintain, heart, blood vessel, lung, and blood disease
and blood resource laboratories, research, training,
and other facilities, equipment, and such other real or
personal property as the Director determines necessary;
(B) may, in consultation with the advisory council
for the Institute, make grants for construction or
renovation of facilities; and
(C) may, in consultation with the advisory council
for the Institute, acquire, without regard to the Act
of March 3, 1877 (40 U.S.C. 34), by lease or otherwise,
through the Administrator of General Services,
buildings or parts of buildings in the District of
Columbia or communities located adjacent to the
District of Columbia for the use of the Institute for a
period not to exceed ten years;
(3) subject to section 405(b)(2) and without regard
to section 3324 of title 31, United States Code, and
section 3709 of the Revised Statutes (41 U.S.C. 5), may
enter into such contracts, leases, cooperative
agreements, or other transactions, as may be necessary
in the conduct of the Director's functions, with any
public agency, or with any person, firm, association,
corporation, or educational institutions;
(4) may make grants to public and nonprofit private
entities to assist in meeting the cost of the care of
patients in hospitals, clinics, and related facilities
who are participating in research projects; and
(5) shall, in consultation with the advisory
council for the Institute, conduct appropriate
intramural training and education programs, including
continuing education and laboratory and clinical
research training programs.
Except as otherwise provided, experts and consultants whose
services are obtained under paragraph (1) shall be paid or
reimbursed, in accordance with title 5, United States Code, for
their travel to and from their place of service and for other
expenses associated with their assignment. Such expenses shall
not be allowed in connection with the assignment of an expert
or consultant whose services are obtained under paragraph (1)
unless the expert or consultant has agreed in writing to
complete the entire period of the assignment or one year of the
assignment, whichever is shorter, unless separated or
reassigned for reasons which are beyond the control of the
expert or consultant and which are acceptable to the Director
of the Institute. If the expert or consultant violates the
agreement, the money spent by the United States for such
expenses is recoverable from the expert or consultant as a debt
due the United States. The Secretary may waive in whole or in
part a right of recovery under the preceding sentence.
NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD VESSEL,
LUNG, AND BLOOD DISEASES, SICKLE CELL ANEMIA, AND BLOOD RESOURCES
Sec. 422. [285b-4] (a)(1) The Director of the Institute may
provide, in accordance with subsection (c), for the development
of--
(A) ten centers for basic and clinical research
into, training in, and demonstration of, advanced
diagnostic, prevention, and treatment and
rehabilitation methods (including methods of providing
emergency medical services) for heart and blood vessel
diseases;
(B) ten centers for basic and clinical research
into, training in, and demonstration of, advanced
diagnostic, prevention, and treatment and
rehabilitation methods (including methods of providing
emergency medical services) for lung diseases
(including bronchitis, emphysema, asthma, cystic
fibrosis, and other lung diseases of children);
(C) ten centers for basic and clinical research
into, training in, and demonstration of, advanced
diagnostic, prevention, and treatment methods
(including methods of providing emergency medical
services) for blood diseases and research into blood,
in the use of blood products and in the management of
blood resources; and
(D) three centers for basic and clinical research
into, training in, and demonstration of, advanced
diagnostic, prevention, and treatment (including
genetic studies, intrauterine environment studies,
postnatal studies, heart arrhythmias, and acquired
heart disease and preventive cardiology) for
cardiovascular diseases in children.
(2) The centers developed under paragraph (1) shall, in
addition to being utilized for research, training, and
demonstrations, be utilized for the following prevention
programs for cardiovascular, pulmonary, and blood diseases:
(A) Programs to develop improved methods of
detecting individuals with a high risk of developing
cardiovascular, pulmonary, and blood diseases.
(B) Programs to develop improved methods of
intervention against those factors which cause
individuals to have a high risk of developing such
diseases.
(C) Programs to develop health professions and
allied health professions personnel highly skilled in
the prevention of such diseases.
(D) Programs to develop improved methods of
providing emergency medical services for persons with
such diseases.
(E) Programs of continuing education for health and
allied health professionals in the diagnosis,
prevention, and treatment of such diseases and the
maintenance of health to reduce the incidence of such
diseases and information programs for the public
respecting the prevention and early diagnosis and
treatment of such diseases and the maintenance of
health.
(3) The research, training, and demonstration activities
carried out through any such center may relate to any one or
more of the diseases referred to in paragraph (1) of this
subsection.
(b) The Director of the Institute shall provide, in
accordance with subsection (c), for the development of ten
centers for basic and clinical research into the diagnosis,
treatment, and control of sickle cell anemia.
(c)(1) The Director of the Institute may enter into
cooperative agreements with and make grants to public or
private nonprofit entities to pay all or part of the cost of
planning, establishing, or strengthening, and providing basic
operating support for centers for basic and clinical research
into, training in, and demonstration of the management of blood
resources and advanced diagnostic, prevention, and treatment
methods for heart, blood vessel, lung, or blood diseases.
(2) A cooperative agreement or grant under paragraph (1)
shall be entered into in accordance with policies established
by the Director of NIH and after consultation with the
Institute's advisory council.
(3) Federal payments made under a cooperative agreement or
grant under paragraph (1) may be used for--
(A) construction (notwithstanding any limitation
under section 496);
(B) staffing and other basic operating costs,
including such patient care costs as are required for
research;
(C) training, including training for allied health
professionals; and
(D) demonstration purposes.
As used in this subsection, the term ``construction'' does not
include the acquisition of land, and the term ``training'' does
not include research training for which National Research
Service Awards \1\ may be provided under section 487.
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\1\ Now Ruth L. Kirschstein National Research Service Awards. See
section 487.
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(4) Support of a center under paragraph (1) may be for a
period of not to exceed five years. Such period may be extended
by the Director for additional periods of not more than five
years each if the operations of such center have been reviewed
by an appropriate technical and scientific peer review group
established by the Director and if such group has recommended
to the Director that such period should be extended.
associate director for prevention
Sec. 423. [285b-6] (a) There shall be in the Institute an
Associate Director for Prevention to coordinate and promote the
programs in the Institute concerning the prevention of heart,
blood vessel, lung, and blood diseases. The Associate Director
shall be appointed by the Director of the Institute from
individuals who because of their professional training or
experience are experts in public health or preventive medicine.
(b) The Associate Director for Prevention shall prepare for
inclusion in the biennial report made under section 407 a
description of the prevention activities of the Institute,
including a description of the staff and resources allocated to
those activities.
NATIONAL CENTER ON SLEEP DISORDERS RESEARCH
Sec. 424. [285b-7] (a) Not later than 1 year after the date
of the enactment of the National Institutes of Health
Revitalization Act of 1993, the Director of the Institute shall
establish the National Center on Sleep Disorders Research (in
this section referred to as the ``Center''). The Center shall
be headed by a director, who shall be appointed by the Director
of the Institute.
(b) The general purpose of the Center is--
(1) the conduct and support of research, training,
health information dissemination, and other activities
with respect to sleep disorders, including biological
and circadian rhythm research, basic understanding of
sleep, chronobiological and other sleep related
research; and
(2) to coordinate the activities of the Center with
similar activities of other Federal agencies, including
the other agencies of the National Institutes of
Health, and similar activities of other public entities
and nonprofit entities.
(c)(1) The Director of the National Institutes of Health
shall establish a board to be known as the Sleep Disorders
Research Advisory Board (in this section referred to as the
``Advisory Board'').
(2) The Advisory Board shall advise, assist, consult with,
and make recommendations to the Director of the National
Institutes of Health, through the Director of the Institute,
and the Director of the Center concerning matters relating to
the scientific activities carried out by and through the Center
and the policies respecting such activities, including
recommendations with respect to the plan required in subsection
(c) \1\.
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\1\ So in law. See section 503 of Public Law 103-43 (107 Stat.
159). Probably should be ``subsection (d)''.
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(3)(A) The Director of the National Institutes of Health
shall appoint to the Advisory Board 12 appropriately qualified
representatives of the public who are not officers or employees
of the Federal Government. Of such members, eight shall be
representatives of health and scientific disciplines with
respect to sleep disorders and four shall be individuals
representing the interests of individuals with or undergoing
treatment for sleep disorders.
(B) The following officials shall serve as ex officio
members of the Advisory Board:
(i) The Director of the National Institutes of
Health.
(ii) The Director of the Center.
(iii) The Director of the National Heart, Lung and
Blood Institute.
(iv) The Director of the National Institute of
Mental Health.
(v) The Director of the National Institute on
Aging.
(vi) The Director of the Eunice Kennedy Shriver
National Institute of Child Health and Human
Development.
(vii) The Director of the National Institute of
Neurological Disorders and Stroke.
(viii) The Assistant Secretary for Health.
(ix) The Assistant Secretary of Defense (Health
Affairs).
(x) The Chief Medical Director of the Veterans'
Administration.
(4) The members of the Advisory Board shall, from among the
members of the Advisory Board, designate an individual to serve
as the chair of the Advisory Board.
(5) Except as inconsistent with, or inapplicable to, this
section, the provisions of section 406 shall apply to the
advisory board \2\ established under this section in the same
manner as such provisions apply to any advisory council
established under such section.
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\2\ So in law. See section 503 of Public Law 103-43 (107 Stat.
159). Probably should be capitalized.
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(d)(1) After consultation with the Director of the Center
and the advisory board established under subsection (c), the
Director of the National Institutes of Health shall develop a
comprehensive plan for the conduct and support of sleep
disorders research.
(2) The plan developed under paragraph (1) shall identify
priorities with respect to such research and shall provide for
the coordination of such research conducted or supported by the
agencies of the National Institutes of Health.
(3) The Director of the National Institutes of Health
(after consultation with the Director of the Center and the
advisory board established under subsection (c)) shall revise
the plan developed under paragraph (1) as appropriate.
(e) The Director of the Center, in cooperation with the
Centers for Disease Control and Prevention, is authorized to
coordinate activities with the Department of Transportation,
the Department of Defense, the Department of Education, the
Department of Labor, and the Department of Commerce to collect
data, conduct studies, and disseminate public information
concerning the impact of sleep disorders and sleep deprivation.
HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN
Sec. 424A. [285b-7a] (a) In General.--The Director of the
Institute shall expand, intensify, and coordinate research and
related activities of the Institute with respect to heart
attack, stroke, and other cardiovascular diseases in women.
(b) Coordination With Other Institutes.--The Director of
the Institute shall coordinate activities under subsection (a)
with similar activities conducted by the other national
research institutes and agencies of the National Institutes of
Health to the extent that such Institutes and agencies have
responsibilities that are related to heart attack, stroke, and
other cardiovascular diseases in women.
(c) Certain Programs.--In carrying out subsection (a), the
Director of the Institute shall conduct or support research to
expand the understanding of the causes of, and to develop
methods for preventing, cardiovascular diseases in women.
Activities under such subsection shall include conducting and
supporting the following:
(1) Research to determine the reasons underlying
the prevalence of heart attack, stroke, and other
cardiovascular diseases in women, including African-
American women and other women who are members of
racial or ethnic minority groups.
(2) Basic research concerning the etiology and
causes of cardiovascular diseases in women.
(3) Epidemiological studies to address the
frequency and natural history of such diseases and the
differences among men and women, and among racial and
ethnic groups, with respect to such diseases.
(4) The development of safe, efficient, and cost-
effective diagnostic approaches to evaluating women
with suspected ischemic heart disease.
(5) Clinical research for the development and
evaluation of new treatments for women, including
rehabilitation.
(6) Studies to gain a better understanding of
methods of preventing cardiovascular diseases in women,
including applications of effective methods for the
control of blood pressure, lipids, and obesity.
(7) Information and education programs for patients
and health care providers on risk factors associated
with heart attack, stroke, and other cardiovascular
diseases in women, and on the importance of the
prevention or control of such risk factors and timely
referral with appropriate diagnosis and treatment. Such
programs shall include information and education on
health-related behaviors that can improve such
important risk factors as smoking, obesity, high blood
cholesterol, and lack of exercise.
COORDINATION OF FEDERAL ASTHMA ACTIVITIES
Sec. 424B \1\ [285b-7b] (a) In General.--The Director of
Institute shall, through the National Asthma Education
Prevention Program Coordinating Committee--
---------------------------------------------------------------------------
\1\ So in law. The section designation lacks a period. See section
521 of Public Law 106-310 (114 Stat. 1116).
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(1) identify all Federal programs that carry out
asthma-related activities; and
(2) develop, in consultation with appropriate
Federal agencies and professional and voluntary health
organizations, a Federal plan for responding to asthma.
(b) Representation of the Department of Housing and Urban
Development.--A representative of the Department of Housing and
Urban Development shall be included on the National Asthma
Education Prevention Program Coordinating Committee for the
purpose of performing the tasks described in subsection (a).
\1\
---------------------------------------------------------------------------
\1\ Section 425 was repealed by section 103(b)(20) of Public Law
109-482 (120 Stat. 3688).
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SEC. 424C. [285B-7C] TUBERCULOSIS.
(a) In General.--The Director of the National Institutes of
Health may expand, intensify, and coordinate research and
development and related activities of the Institutes with
respect to tuberculosis including activities toward the goal of
eliminating such disease.
(b) Certain Activities.--Activities under subsection (a)
may include--
(1) enhancing basic and clinical research on
tuberculosis, including drug resistant tuberculosis;
(2) expanding research on the relationship between
such disease and the human immunodeficiency virus; and
(3) developing new tools for the elimination of
tuberculosis, including public health interventions and
methods to enhance detection and response to outbreaks
of tuberculosis, including multidrug resistant
tuberculosis.
SEC. 425. [285B-8] CONGENITAL HEART DISEASE.
(a) In General.--The Director of the Institute may expand,
intensify, and coordinate research and related activities of
the Institute with respect to congenital heart disease, which
may include congenital heart disease research with respect to--
(1) causation of congenital heart disease,
including genetic causes;
(2) long-term outcomes in individuals with
congenital heart disease, including infants, children,
teenagers, adults, and elderly individuals;
(3) diagnosis, treatment, and prevention;
(4) studies using longitudinal data and
retrospective analysis to identify effective treatments
and outcomes for individuals with congenital heart
disease; and
(5) identifying barriers to life-long care for
individuals with congenital heart disease.
(b) Coordination of Research Activities.--The Director of
the Institute may coordinate research efforts related to
congenital heart disease among multiple research institutions
and may develop research networks.
(c) Minority and Medically Underserved Communities.--In
carrying out the activities described in this section, the
Director of the Institute shall consider the application of
such research and other activities to minority and medically
underserved communities.
Subpart 3--National Institute of Diabetes and Digestive and Kidney
Diseases
PURPOSE OF THE INSTITUTE
Sec. 426. [285c] The general purpose of the National
Institute of Diabetes and Digestive and Kidney Diseases
(hereafter in this subpart referred to as the ``Institute'') is
the conduct and support of research, training, health
information dissemination, and other programs with respect to
diabetes mellitus and endocrine and metabolic diseases,
digestive diseases and nutritional disorders, and kidney,
urologic, and hematologic diseases.
DATA SYSTEMS AND INFORMATION CLEARINGHOUSES
Sec. 427. [285c-1] (a) The Director of the Institute shall
(1) establish the National Diabetes Data System for the
collection, storage, analysis, retrieval, and dissemination of
data derived from patient populations with diabetes, including,
where possible, data involving general populations for the
purpose of detection of individuals with a risk of developing
diabetes, and (2) establish the National Diabetes Information
Clearinghouse to facilitate and enhance knowledge and
understanding of diabetes on the part of health professionals,
patients, and the public through the effective dissemination of
information.
(b) The Director of the Institute shall (1) establish the
National Digestive Diseases Data System for the collection,
storage, analysis, retrieval, and dissemination of data derived
from patient populations with digestive diseases, including,
where possible, data involving general populations for the
purpose of detection of individuals with a risk of developing
digestive diseases, and (2) establish the National Digestive
Diseases Information Clearinghouse to facilitate and enhance
knowledge and understanding of digestive diseases on the part
of health professionals, patients, and the public through the
effective dissemination of information.
(c) The Director of the Institute shall (1) establish the
National Kidney and Urologic Diseases Data System for the
collection, storage, analysis, retrieval, and dissemination of
data derived from patient populations with kidney and urologic
diseases, including, where possible, data involving general
populations for the purpose of detection of individuals with a
risk of developing kidney and urologic diseases, and (2)
establish the National Kidney and Urologic Diseases Information
Clearinghouse to facilitate and enhance knowledge and
understanding of kidney and urologic diseases on the part of
health professionals, patients, and the public through the
effective dissemination of information.
DIVISION DIRECTORS FOR DIABETES, ENDOCRINOLOGY, AND METABOLIC DISEASES,
DIGESTIVE DISEASES AND NUTRITION, AND KIDNEY, UROLOGIC, AND HEMATOLOGIC
DISEASES
Sec. 428. [285c-2] (a)(1) In the Institute there shall be a
Division Director for Diabetes, Endocrinology, and Metabolic
Diseases, a Division Director for Digestive Diseases and
Nutrition, and a Division Director for Kidney, Urologic, and
Hematologic Diseases. Such Division Directors, under the
supervision of the Director of the Institute, shall be
responsible for--
(A) developing a coordinated plan (including
recommendations for expenditures) for each of the
national research institutes within the National
Institutes of Health with respect to research and
training concerning diabetes, endocrine and metabolic
diseases, digestive diseases and nutrition, and kidney,
urologic, and hematologic diseases;
(B) assessing the adequacy of management approaches
for the activities within such institutes concerning
such diseases and nutrition and developing improved
approaches if needed;
(C) monitoring and reviewing expenditures by such
institutes concerning such diseases and nutrition; and
(D) identifying research opportunities concerning
such diseases and nutrition and recommending ways to
utilize such opportunities.
(2) The Director of the Institute shall transmit to the
Director of NIH the plans, recommendations, and reviews of the
Division Directors under subparagraphs (A) through (D) of
paragraph (1) together with such comments and recommendations
as the Director of the Institute determines appropriate.
(b) The Director of the Institute, acting through the
Division Director for Diabetes, Endocrinology, and Metabolic
Diseases, the Division Director for Digestive Diseases and
Nutrition, and the Division Director for Kidney, Urologic, and
Hematologic Diseases, shall--
(1) carry out programs of support for research and
training (other than training for which National
Research Service Awards \1\ may be made under section
487) in the diagnosis, prevention, and treatment of
diabetes mellitus and endocrine and metabolic diseases,
digestive diseases and nutritional disorders, and
kidney, urologic, and hematologic diseases, including
support for training in medical schools, graduate
clinical training, graduate training in epidemiology,
epidemiology studies, clinical trials, and
interdisciplinary research programs; and
---------------------------------------------------------------------------
\1\ Now Ruth L. Kirschstein National Research Service Awards. See
section 487.
---------------------------------------------------------------------------
(2) establish programs of evaluation, planning, and
dissemination of knowledge related to such research and
training.
INTERAGENCY COORDINATING COMMITTEES
Sec. 429. [285c-3] (a) For the purpose of--
(1) better coordination of the research activities
of all the national research institutes relating to
diabetes mellitus, digestive diseases, and kidney,
urologic, and hematologic diseases; and
(2) coordinating those aspects of all Federal
health programs and activities relating to such
diseases to assure the adequacy and technical soundness
of such programs and activities and to provide for the
full communication and exchange of information
necessary to maintain adequate coordination of such
programs and activities;
the Secretary shall establish a Diabetes Mellitus Interagency
Coordinating Committee, a Digestive Diseases Interagency
Coordinating Committee, and a Kidney, Urologic, and Hematologic
Diseases Coordinating Committee (hereafter in this section
individually referred to as a ``Committee'').
(b) Each Committee shall be composed of the Directors of
each of the national research institutes and divisions involved
in research with respect to the diseases for which the
Committee is established, the Division Director of the
Institute for the diseases for which the Committee is
established, the Chief Medical Director of the Veterans'
Administration, and the Assistant Secretary of Defense for
Health Affairs (or the designees of such officers) and shall
include representation from all other Federal departments and
agencies whose programs involve health functions or
responsibilities relevant to such diseases, as determined by
the Secretary. Each Committee shall be chaired by the Director
of NIH (or the designee of the Director). Each Committee shall
meet at the call of the chairman, but not less often than four
times a year.
ADVISORY BOARDS
Sec. 430. [285c-4] (a) The Secretary shall establish in the
Institute the National Diabetes Advisory Board, the National
Digestive Diseases Advisory Board, and the National Kidney and
Urologic Diseases Advisory Board (hereafter in this section
individually referred to as an ``Advisory Board'').
(b) Each Advisory Board shall be composed of eighteen
appointed members and nonvoting ex officio members as follows:
(1) The Secretary shall appoint--
(A) twelve members from individuals who are
scientists, physicians, and other health
professionals, who are not officers or
employees of the United States, and who
represent the specialties and disciplines
relevant to the diseases with respect to which
the Advisory Board is established; and
(B) six members from the general public who
are knowledgeable with respect to such
diseases, including at least one member who is
a person who has such a disease and one member
who is a parent of a person who has such a
disease.
Of the appointed members at least five shall by virtue
of training or experience be knowledgeable in the
fields of health education, nursing, data systems,
public information, and community program development.
(2)(A) The following shall be ex officio members of
each Advisory Board:
(i) The Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute of Diabetes and Digestive and Kidney
Diseases, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs, the Assistant Secretary of Defense for
Health Affairs, and the Division Director of
the National Institute of Diabetes and
Digestive and Kidney Diseases for the diseases
for which the Board is established (or the
designees of such officers).
(ii) Such other officers and employees of
the United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
(B) In the case of the National Diabetes Advisory
Board, the following shall also be ex officio members:
The Director of the National Heart, Lung, and Blood
Institute, the Director of the National Eye Institute,
the Director of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development, and
the Administrator of the Health Resources and Services
Administration (or the designees of such officers).
(c) Members of an Advisory Board who are officers or
employees of the Federal Government shall serve as members of
the Advisory Board without compensation in addition to that
received in their regular public employment. Other members of
the Board shall receive compensation at rates not to exceed the
daily equivalent of the annual rate in effect for grade GS-18
of the General Schedule for each day (including traveltime)
they are engaged in the performance of their duties as members
of the Board.
(d) The term of office of an appointed member of an
Advisory Board is four years, except that no term of office may
extend beyond the expiration of the Advisory Board. Any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A member may serve
after the expiration of the member's term until a successor has
taken office. If a vacancy occurs in an Advisory Board, the
Secretary shall make an appointment to fill the vacancy not
later than 90 days from the date the vacancy occurred.
(e) The members of each Advisory Board shall select a
chairman from among the appointed members.
(f) The Secretary shall, after consultation with and
consideration of the recommendations of an Advisory Board,
provide the Advisory Board with an executive director and one
other professional staff member. In addition, the Secretary
shall, after consultation with and consideration of the
recommendations of the Advisory Board, provide the Advisory
Board with such additional professional staff members, such
clerical staff members, such services of consultants, such
information, and (through contracts or other arrangements) such
administrative support services and facilities, as the
Secretary determines are necessary for the Advisory Board to
carry out its functions.
(g) Each Advisory Board shall meet at the call of the
chairman or upon request of the Director of the Institute, but
not less often than four times a year.
(h) The National Diabetes Advisory Board and the National
Digestive Diseases Advisory Board shall--
(1) review and evaluate the implementation of the
plan (referred to in section 433) respecting the
diseases with respect to which the Advisory Board was
established and periodically update the plan to ensure
its continuing relevance;
(2) for the purpose of assuring the most effective
use and organization of resources respecting such
diseases, advise and make recommendations to the
Congress, the Secretary, the Director of NIH, the
Director of the Institute, and the heads of other
appropriate Federal agencies for the implementation and
revision of such plan; and
(3) maintain liaison with other advisory bodies
related to Federal agencies involved in the
implementation of such plan, the coordinating committee
for such diseases, and with key non-Federal entities
involved in activities affecting the control of such
diseases.
(i) In carrying out its functions, each Advisory Board may
establish subcommittees, convene workshops and conferences, and
collect data. Such subcommittees may be composed of Advisory
Board members and nonmember consultants with expertise in the
particular area addressed by such subcommittees. The
subcommittees may hold such meetings as are necessary to enable
them to carry out their activities.
(j) The National Diabetes Advisory Board and the National
Digestive Diseases Advisory Board in existence on the date of
enactment of the Health Research Extension Act of 1985 shall
terminate upon the appointment of a successor Board under
subsection (a). The Secretary shall make appointments to the
Advisory Boards established under subsection (a) before the
expiration of 90 days after such date. The members of the
Boards in existence on such date may be appointed, in
accordance with subsections (b) and (d), to the Boards
established under subsection (a) for diabetes and digestive
diseases, except that at least one-half of the members of the
National Diabetes Advisory Board in existence on the date of
enactment of the Health Research Extension Act of 1985 shall be
appointed to the National Diabetes Advisory Board first
established under subsection (a).
RESEARCH AND TRAINING CENTERS
Sec. 431. [285c-5] (a)(1) Consistent with applicable
recommendations of the National Commission on Diabetes, the
Director of the Institute shall provide for the development or
substantial expansion of centers for research and training in
diabetes mellitus and related endocrine and metabolic diseases.
Each center developed or expanded under this subsection shall--
(A) utilize the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such research and training
qualifications as may be prescribed by the Secretary;
and
(B) conduct--
(i) research in the diagnosis and treatment
of diabetes mellitus and related endocrine and
metabolic diseases and the complications
resulting from such diseases;
(ii) training programs for physicians and
allied health personnel in current methods of
diagnosis and treatment of such diseases and
complications, and in research in diabetes; and
(iii) information programs for physicians
and allied health personnel who provide primary
care for patients with such diseases or
complications.
(2) A center may use funds provided under paragraph (1) to
provide stipends for nurses and allied health professionals
enrolled in research training programs described in paragraph
(1)(B)(ii).
(b) Consistent with applicable recommendations of the
National Digestive Diseases Advisory Board, the Director shall
provide for the development or substantial expansion of centers
for research in digestive diseases and related functional,
congenital, metabolic disorders, and normal development of the
digestive tract. Each center developed or expanded under this
subsection--
(1) shall utilize the facilities of a single
institution, or be formed from a consortium of
cooperating institutions, meeting such research
qualifications as may be prescribed by the Secretary;
(2) shall develop and conduct basic and clinical
research into the cause, diagnosis, early detection,
prevention, control, and treatment of digestive
diseases and nutritional disorders and related
functional, congenital, or metabolic complications
resulting from such diseases or disorders;
(3) shall encourage research into and programs
for--
(A) providing information for patients with
such diseases and the families of such
patients, physicians and others who care for
such patients, and the general public;
(B) model programs for cost effective and
preventive patient care; and
(C) training physicians and scientists in
research on such diseases, disorders, and
complications; and
(4) may perform research and participate in
epidemiological studies and data collection relevant to
digestive diseases and disorders and disseminate such
research, studies, and data to the health care
profession and to the public.
(c) The Director shall provide for the development or
substantial expansion of centers for research in kidney and
urologic diseases. Each center developed or expanded under this
subsection--
(1) shall utilize the facilities of a single
institution, or be formed from a consortium of
cooperating institutions, meeting such research
qualifications as may be prescribed by the Secretary;
shall develop and conduct basic and clinical research
into the cause, diagnosis, early detection, prevention,
control, and treatment of kidney and urologic diseases;
(3) shall encourage research into and programs
for--
(A) providing information for patients with
such diseases, disorders, and complications and
the families of such patients, physicians and
others who care for such patients, and the
general public;
(B) model programs for cost effective and
preventive patient care; and
(C) training physicians and scientists in
research on such diseases; and
(4) may perform research and participate in
epidemiological studies and data collection relevant to
kidney and urologic diseases in order to disseminate
such research, studies, and data to the health care
profession and to the public.
(d)(1) The Director of the Institute shall, subject to the
extent of amounts made available in appropriations Acts,
provide for the development or substantial expansion of centers
for research and training regarding nutritional disorders,
including obesity.
(2) The Director of the Institute shall carry out paragraph
(1) in collaboration with the Director of the National Cancer
Institute and with the Directors of such other agencies of the
National Institutes of Health as the Director of NIH determines
to be appropriate.
(3) Each center developed or expanded under paragraph (1)
shall--
(A) utilize the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such research and training
qualifications as may be prescribed by the Director;
(B) conduct basic and clinical research into the
cause, diagnosis, early detection, prevention, control
and treatment of nutritional disorders, including
obesity and the impact of nutrition and diet on child
development;
(C) conduct training programs for physicians and
allied health professionals in current methods of
diagnosis and treatment of such diseases and
complications, and in research in such disorders; and
(D) conduct information programs for physicians and
allied health professionals who provide primary care
for patients with such disorders or complications.
(e) Insofar as practicable, centers developed or expanded
under this section should be geographically dispersed
throughout the United States and in environments with proven
research capabilities. Support of a center under this section
may be for a period of not to exceed five years and such period
may be extended by the Director of the Institute for additional
periods of not more than five years each if the operations of
such center have been reviewed by an appropriate technical and
scientific peer review group established by the Director and if
such group has recommended to the Director that such period
should be extended.
ADVISORY COUNCIL SUBCOMMITTEES
Sec. 432. [285c-6] There are established within the
advisory council for the Institute appointed under section 406
a subcommittee on diabetes and endocrine and metabolic
diseases, a subcommittee on digestive diseases and nutrition,
and a subcommittee on kidney, urologic, and hematologic
diseases. The subcommittees shall be composed of members of the
advisory council who are outstanding in the diagnosis,
prevention, and treatment of the diseases for which the
subcommittees are established and members of the advisory
council who are leaders in the fields of education and public
affairs. The subcommittees are authorized to review
applications made to the Director of the Institute for grants
for research and training projects relating to the diagnosis,
prevention, and treatment of the diseases for which the
subcommittees are established and shall recommend to the
advisory council those applications and contracts that the
subcommittees determine will best carry out the purposes of the
Institute. The subcommittees shall also review and evaluate the
diabetes and endocrine and metabolic diseases, digestive
diseases and nutrition, and kidney, urologic, and hematologic
diseases programs of the Institute and recommend to the
advisory council such changes in the administration of such
programs as the subcommittees determine are necessary.
BIENNIAL REPORT
Sec. 433. [285c-7] The Director of the Institute shall
prepare for inclusion in the biennial report made under section
407 a description of the Institute's activities--
(1) under the current diabetes plan under the
National Diabetes Mellitus Research and Education Act;
and
(2) under the current digestive diseases plan
formulated under the Arthritis, Diabetes, and Digestive
Diseases Amendments of 1976.
The description submitted by the Director shall include an
evaluation of the activities of the centers supported under
section 431.
H3 deg.NUTRITIONAL DISORDERS PROGRAM
Sec. 434. [285c-8] (a) The Director of the Institute, in
consultation with the Director of NIH, shall establish a
program of conducting and supporting research, training, health
information dissemination, and other activities with respect to
nutritional disorders, including obesity.
(b) In carrying out the program established under
subsection (a), the Director of the Institute shall conduct and
support each of the activities described in such subsection.
(c) In carrying out the program established under
subsection (a), the Director of the Institute shall carry out
activities to facilitate and enhance knowledge and
understanding of nutritional disorders, including obesity, on
the part of health professionals, patients, and the public
through the effective dissemination of information.
JUVENILE DIABETES
Sec. 434A. [285c-9] (a) Long-Term Epidemiology Studies.--
The Director of the Institute shall conduct or support long-
term epidemiology studies in which individuals with or at risk
for type 1, or juvenile, diabetes are followed for 10 years or
more. Such studies shall investigate the causes and
characteristics of the disease and its complications.
(b) Clinical Trial Infrastructure/Innovative Treatments for
Juvenile Diabetes.--The Secretary, acting through the Director
of the National Institutes of Health, shall support regional
clinical research centers for the prevention, detection,
treatment, and cure of juvenile diabetes.
(c) Prevention of Type 1 Diabetes.--The Secretary, acting
through the appropriate agencies, shall provide for a national
effort to prevent type 1 diabetes. Such effort shall provide
for a combination of increased efforts in research and
development of prevention strategies, including consideration
of vaccine development, coupled with appropriate ability to
test the effectiveness of such strategies in large clinical
trials of children and young adults.
Subpart 4--National Institute of Arthritis and Musculoskeletal and Skin
Diseases
PURPOSE OF THE INSTITUTE
Sec. 435. [285d] The general purpose of the National
Institute of Arthritis and Musculoskeletal and Skin Diseases
(hereafter in this subpart referred to as the ``Institute'') is
the conduct and support of research and training, the
dissemination of health information, and other programs with
respect to arthritis and musculoskeletal and skin diseases
(including sports-related disorders), with particular attention
to the effect of these diseases on children.* deg.
NATIONAL ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES PROGRAM
Sec. 436. [285d-1] (a) The Director of the Institute, with
the advice of the Institute's advisory council, shall prepare
and transmit to the Director of NIH a plan for a national
arthritis and musculoskeletal and skin diseases program to
expand, intensify, and coordinate the activities of the
Institute respecting arthritis and musculoskeletal and skin
diseases. The plan shall include such comments and
recommendations as the Director of the Institute determines
appropriate. The plan shall place particular emphasis upon
expanding research into better understanding the causes and the
development of effective treatments for arthritis affecting
children. The Director of the Institute shall periodically
review and revise such plan and shall transmit any revisions of
such plan to the Director of NIH.
(b) Activities under the national arthritis and
musculoskeletal and skin diseases program shall be coordinated
with the other national research institutes to the extent that
such institutes have responsibilities respecting arthritis and
musculoskeletal and skin diseases, and shall, at least, provide
for--
(1) investigation into the epidemiology, etiology,
and prevention of all forms of arthritis and
musculoskeletal and skin diseases, including sports-
related disorders, primarily through the support of
basic research in such areas as immunology, genetics,
biochemistry, microbiology, physiology, bioengineering,
and any other scientific discipline which can
contribute important knowledge to the treatment and
understanding of arthritis and musculoskeletal and skin
diseases;
(2) research into the development, trial, and
evaluation of techniques, drugs, and devices used in
the diagnosis, treatment, including medical
rehabilitation, and prevention of arthritis and
musculoskeletal and skin diseases;
(3) research on the refinement, development, and
evaluation of technological devices that will replace
or be a substitute for damaged bone, muscle, and joints
and other supporting structures;
(4) the establishment of mechanisms to monitor the
causes of athletic injuries and identify ways of
preventing such injuries on scholastic athletic fields;
and
(5) research into the causes of arthritis affecting
children and the development, trial, and evaluation of
techniques, drugs and devices used in the diagnosis,
treatment (including medical rehabilitation), and
prevention of arthritis in children.
(c) The Director of the Institute shall carry out the
national arthritis and musculoskeletal and skin diseases
program in accordance with the plan prepared under subsection
(a) and any revisions of such plan made under such subsection.
RESEARCH AND TRAINING
Sec. 437. [285d-2] The Director of the Institute shall--
(1) carry out programs of support for research and
training (other than training for which National
Research Service Awards \1\ may be made under section
487) in the diagnosis, prevention, and treatment of
arthritis and musculoskeletal and skin diseases,
including support for training in medical schools,
graduate clinical training, graduate training in
epidemiology, epidemiology studies, clinical trials,
and interdisciplinary research programs; and
---------------------------------------------------------------------------
\1\ Now Ruth L. Kirschstein National Research Service Awards. See
section 487.
---------------------------------------------------------------------------
(2) establish programs of evaluation, planning, and
dissemination of knowledge related to such research and
training.
DATA SYSTEM AND INFORMATION CLEARINGHOUSE
Sec. 438. [285d-3] (a) The Director of the Institute shall
establish the National Arthritis and Musculoskeletal and Skin
Diseases Data System for the collection, storage, analysis,
retrieval, and dissemination of data derived from patient
populations with arthritis and musculoskeletal and skin
diseases, including where possible, data involving general
populations for the purpose of detection of individuals with a
risk of developing arthritis and musculoskeletal and skin
diseases.
(b) The Director of the Institute shall establish the
National Arthritis and Musculoskeletal and Skin Diseases
Information Clearinghouse to facilitate and enhance, through
the effective dissemination of information, knowledge and
understanding of arthritis and musculoskeletal and skin
diseases, including juvenile arthritis and related conditions,
by health professionals, patients, and the public.
INTERAGENCY COORDINATING COMMITTEES
Sec. 439. [285d-4] (a) For the purpose of--
(1) better coordination of the research activities
of all the national research institutes relating to
arthritis, musculoskeletal diseases, and skin diseases,
including sports-related disorders; and
(2) coordinating the aspects of all Federal health
programs and activities relating to arthritis,
musculoskeletal diseases, and skin diseases in order to
assure the adequacy and technical soundness of such
programs and activities and in order to provide for the
full communication and exchange of information
necessary to maintain adequate coordination of such
programs and activities,
the Secretary shall establish an Arthritis and Musculoskeletal
Diseases Interagency Coordinating Committee and a Skin Diseases
Interagency Coordinating Committee (hereafter in this section
individually referred to as a ``Committee'').
(b) Each Committee shall be composed of the Directors of
each of the national research institutes and divisions involved
in research regarding the diseases with respect to which the
Committee is established, the Chief Medical Director of the
Department of Veterans Affairs, and the Assistant Secretary of
Defense for Health Affairs (or the designees of such officers),
and representatives of all other Federal departments and
agencies (as determined by the Secretary) whose programs
involve health functions or responsibilities relevant to
arthritis and musculoskeletal diseases or skin diseases, as the
case may be. Each Committee shall be chaired by the Director of
NIH (or the designee of the Director). Each Committee shall
meet at the call of the chairman, but not less often than four
times a year.
ARTHRITIS AND MUSCULOSKELETAL DISEASES DEMONSTRATION PROJECTS
Sec. 440. [285d-5] (a) The Director of the Institute may
make grants to public and private nonprofit entities to
establish and support projects for the development and
demonstration of methods for screening, detection, and referral
for treatment of arthritis and musculoskeletal diseases and for
the dissemination of information on such methods to the health
and allied health professions. Activities under such projects
shall be coordinated with Federal, State, local, and regional
health agencies, centers assisted under section 441, and the
data system established under subsection (c).
(b) Projects supported under this section shall include--
(1) programs which emphasize the development and
demonstration of new and improved methods of screening
and early detection, referral for treatment, and
diagnosis of individuals with a risk of developing
arthritis and musculoskeletal diseases;
(2) programs which emphasize the development and
demonstration of new and improved methods for patient
referral from local hospitals and physicians to
appropriate centers for early diagnosis and treatment;
(3) programs which emphasize the development and
demonstration of new and improved means of
standardizing patient data and recordkeeping;
(4) programs which emphasize the development and
demonstration of new and improved methods of
dissemination of knowledge about the programs, methods,
and means referred to in paragraphs (1), (2), and (3)
of this subsection to health and allied health
professionals;
(5) programs which emphasize the development and
demonstration of new and improved methods for the
dissemination to the general public of information--
(A) on the importance of early detection of
arthritis and musculoskeletal diseases, of
seeking prompt treatment, and of following an
appropriate regimen; and
(B) to discourage the promotion and use of
unapproved and ineffective diagnostic,
preventive treatment, and control methods for
arthritis and unapproved and ineffective drugs
and devices for arthritis and musculoskeletal
diseases; and
(6) projects for investigation into the
epidemiology of all forms and aspects of arthritis and
musculoskeletal diseases, including investigations into
the social, environmental, behavioral, nutritional, and
genetic determinants and influences involved in the
epidemiology of arthritis and musculoskeletal diseases.
(c) The Director shall provide for the standardization of
patient data and recordkeeping for the collection, storage,
analysis, retrieval, and dissemination of such data in
cooperation with projects assisted under this section, centers
assisted under section 441, and other persons engaged in
arthritis and musculoskeletal disease programs.
MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS
Sec. 441. [285d-6] (a) The Director of the Institute shall,
after consultation with the advisory council for the Institute,
provide for the development, modernization, and operation
(including staffing and other operating costs such as the costs
of patient care required for research) of new and existing
centers for arthritis and musculoskeletal diseases. For
purposes of this section, the term ``modernization'' means the
alteration, remodeling, improvement, expansion, and repair of
existing buildings and the provision of equipment for such
buildings to the extent necessary to make them suitable for use
as centers described in the preceding sentence.
(b) Each center assisted under this section shall--
(1)(A) use the facilities of a single institution
or a consortium of cooperating institutions, and (B)
meet such qualifications as may be prescribed by the
Secretary; and
(2) conduct--
(A) basic and clinical research into the
cause, diagnosis, early detection, prevention,
control, and treatment of and rehabilitation
from arthritis and musculoskeletal diseases and
complications resulting from arthritis and
musculoskeletal diseases, including research
into implantable biomaterials and biomechanical
and other orthopedic procedures;
(B) training programs for physicians,
scientists, and other health and allied health
professionals;
(C) information and continuing education
programs for physicians and other health and
allied health professionals who provide care
for patients with arthritis and musculoskeletal
diseases; and
(D) programs for the dissemination to the
general public of information--
(i) on the importance of early
detection of arthritis and
musculoskeletal diseases, of seeking
prompt treatment, and of following an
appropriate regimen; and
(ii) to discourage the promotion
and use of unapproved and ineffective
diagnostic, preventive, treatment, and
control methods and unapproved and
ineffective drugs and devices.
A center may use funds provided under subsection (a) to provide
stipends for health professionals enrolled in training programs
described in paragraph (2)(B).
(c) Each center assisted under this section may conduct
programs to--
(1) establish the effectiveness of new and improved
methods of detection, referral, and diagnosis of
individuals with a risk of developing arthritis and
musculoskeletal diseases;
(2) disseminate the results of research, screening,
and other activities, and develop means of
standardizing patient data and recordkeeping; and
(3) develop community consultative services to
facilitate the referral of patients to centers for
treatment.
(d) The Director of the Institute shall, insofar as
practicable, provide for an equitable geographical distribution
of centers assisted under this section. The Director shall give
appropriate consideration to the need for centers especially
suited to meeting the needs of children affected by arthritis
and musculoskeletal diseases.
(e) Support of a center under this section may be for a
period of not to exceed five years. Such period may be extended
by the Director of the Institute for one or more additional
periods of not more than five years if the operations of such
center have been reviewed by an appropriate technical and
scientific peer review group established by the Director and if
such group has recommended to the Director that such period
should be extended.
(f) Not later than October 1, 1993, the Director shall
establish a multipurpose arthritis and musculoskeletal disease
center for the purpose of expanding the level of research into
the cause, diagnosis, early detection, prevention, control, and
treatment of, and rehabilitation of children with arthritis and
musculoskeletal diseases.
LUPUS
Sec. 441A. [285d-6a] (a) In General.--The Director of the
Institute shall expand and intensify research and related
activities of the Institute with respect to lupus.
(b) Coordination With Other Institutes.--The Director of
the Institute shall coordinate the activities of the Director
under subsection (a) with similar activities conducted by the
other national research institutes and agencies of the National
Institutes of Health to the extent that such Institutes and
agencies have responsibilities that are related to lupus.
(c) Programs for Lupus.--In carrying out subsection (a),
the Director of the Institute shall conduct or support research
to expand the understanding of the causes of, and to find a
cure for, lupus. Activities under such subsection shall include
conducting and supporting the following:
(1) Research to determine the reasons underlying
the elevated prevalence of lupus in women, including
African-American women.
(2) Basic research concerning the etiology and
causes of the disease.
(3) Epidemiological studies to address the
frequency and natural history of the disease and the
differences among the sexes and among racial and ethnic
groups with respect to the disease.
(4) The development of improved diagnostic
techniques.
(5) Clinical research for the development and
evaluation of new treatments, including new biological
agents.
(6) Information and education programs for health
care professionals and the public.
ADVISORY BOARD
Sec. 442. [285d-7] (a) The Secretary shall establish in the
Institute the National Arthritis and Musculoskeletal and Skin
Diseases Advisory Board (hereafter in this section referred to
as the ``Advisory Board'').
(b) The Advisory Board shall be composed of twenty
appointed members and nonvoting, ex officio members, as
follows:
(1) The Secretary shall appoint--
(A) twelve members from individuals who are
scientists, physicians, and other health
professionals, who are not officers or
employees of the United States, and who
represent the specialties and disciplines
relevant to arthritis, musculoskeletal
diseases, and skin diseases; and
(B) eight members from the general public
who are knowledgeable with respect to such
diseases, including one member who is a person
who has such a disease, one person who is the
parent of an adult with such a disease, and two
members who are parents of children with
arthritis.
Of the appointed members at least five shall by virtue
of training or experience be knowledgeable in health
education, nursing, data systems, public information,
or community program development.
(2) The following shall be ex officio members of
the Advisory Board:
(A) the Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute of Arthritis and Musculoskeletal and
Skin Diseases, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs, and the Assistant Secretary of Defense
for Health Affairs (or the designees of such
officers), and
(B) such other officers and employees of
the United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
(c) Members of the Advisory Board who are officers or
employees of the Federal Government shall serve as members of
the Advisory Board without compensation in addition to that
received in their regular public employment. Other members of
the Advisory Board shall receive compensation at rates not to
exceed the daily equivalent of the annual rate in effect for
grade GS-18 of the General Schedule for each day (including
traveltime) they are engaged in the performance of their duties
as members of the Advisory Board.
(d) The term of office of an appointed member of the
Advisory Board is four years. Any member appointed to fill a
vacancy for an unexpired term shall be appointed for the
remainder of such term. A member may serve after the expiration
of the member's term until a successor has taken office. If a
vacancy occurs in the Advisory Board, the Secretary shall make
an appointment to fill the vacancy not later than 90 days after
the date the vacancy occurred.
(e) The members of the Advisory Board shall select a
chairman from among the appointed members.
(f) The Secretary shall, after consultation with and
consideration of the recommendations of the Advisory Board,
provide the Advisory Board with an executive director and one
other professional staff member. In addition, the Secretary
shall, after consultation with and consideration of the
recommendations of the Advisory Board, provide the Advisory
Board with such additional professional staff members, such
clerical staff members, and (through contracts or other
arrangements) with such administrative support services and
facilities, such information, and such services of consultants,
as the Secretary determines are necessary for the Advisory
Board to carry out its functions.
(g) The Advisory Board shall meet at the call of the
chairman or upon request of the Director of the Institute, but
not less often than four times a year.
(h) The Advisory Board shall--
(1) review and evaluate the implementation of the
plan prepared under section 436(a) and periodically
update the plan to ensure its continuing relevance;
(2) for the purpose of assuring the most effective
use and organization of resources respecting arthritis,
musculoskeletal diseases and skin diseases, advise and
make recommendations to the Congress, the Secretary,
the Director of NIH, the Director of the Institute, and
the heads of other appropriate Federal agencies for the
implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies for
Federal agencies involved in the implementation of such
plan, the interagency coordinating committees for such
diseases established under section 439, and with key
non-Federal entities involved in activities affecting
the control of such diseases.
(i) In carrying out its functions, the Advisory Board may
establish subcommittees, convene workshops and conferences, and
collect data. Such subcommittees may be composed of Advisory
Board members and nonmember consultants with expertise in the
particular area addressed by such subcommittees. The
subcommittees may hold such meetings as are necessary to enable
them to carry out their activities.
(j) The National Arthritis Advisory Board in existence on
the date of enactment of the Health Research Extension Act of
1985 shall terminate upon the appointment of a successor Board
under subsection (a). The Secretary shall make appointments to
the Advisory Board established under subsection (a) before the
expiration of 90 days after such date. The members of the Board
in existence on such date may be appointed, in accordance with
subsections (b) and (d), to the Advisory Board established
under subsection (a).
JUVENILE ARTHRITIS AND RELATED CONDITIONS
Sec. 442A. [285d-8] (a) Expansion and Coordination of
Activities.--The Director of the Institute, in coordination
with the Director of the National Institute of Allergy and
Infectious Diseases, shall expand and intensify the programs of
such Institutes with respect to research and related activities
concerning juvenile arthritis and related conditions.
(b) Coordination.--The Directors referred to in subsection
(a) shall jointly coordinate the programs referred to in such
subsection and consult with the Arthritis and Musculoskeletal
Diseases Interagency Coordinating Committee.
Subpart 5--National Institute on Aging
PURPOSE OF THE INSTITUTE
Sec. 443. [285e] The general purpose of the National
Institute on Aging (hereafter in this subpart referred to as
the ``Institute'') is the conduct and support of biomedical,
social, and behavioral research, training, health information
dissemination, and other programs with respect to the aging
process and the diseases and other special problems and needs
of the aged.
SPECIAL FUNCTIONS
Sec. 444. [285e-1] (a) In carrying out the training
responsibilities under this Act or any other Act for health and
allied health professions personnel, the Secretary shall take
appropriate steps to insure the education and training of
adequate numbers of allied health, nursing, and paramedical
personnel in the field of health care for the aged.
(b) The Director of the Institute shall conduct scientific
studies to measure the impact on the biological, medical,
social, and psychological aspects of aging of programs and
activities assisted or conducted by the Department of Health
and Human Services.
(c) The Director of the Institute shall carry out public
information and education programs designed to disseminate as
widely as possible the findings of research sponsored by the
Institute, other relevant aging research and studies, and other
information about the process of aging which may assist elderly
and near-elderly persons in dealing with, and all Americans in
understanding, the problems and processes associated with
growing older.
(d) The Director of the Institute shall make grants to
public and private nonprofit institutions to conduct research
relating to Alzheimer's Disease.
ALZHEIMER'S DISEASE CENTERS
Sec. 445. [285e-2] (a)(1) The Director of the Institute may
enter into cooperative agreements with and make grants to
public or private nonprofit entities (including university
medical centers) to pay all or part of the cost of planning,
establishing, or strengthening, and providing basic operating
support (including staffing) for centers for basic and clinical
research (including multidisciplinary research) into, training
in, and demonstration of advanced diagnostic, prevention, and
treatment methods for Alzheimer's disease.
(2) A cooperative agreement or grant under paragraph (1)
shall be entered into in accordance with policies established
by the Director of NIH and after consultation with the
Institute's advisory council.
(b)(1) Federal payments made under a cooperative agreement
or grant under subsection (a) may, with respect to Alzheimer's
disease, be used for--
(A) diagnostic examinations, patient assessments,
patient care costs, and other costs necessary for
conducting research;
(B) training, including training for allied
health professionals;
(C) diagnostic and treatment clinics designed to
meet the special needs of minority and rural
populations and other underserved populations;
(D) activities to educate the public; and
(E) the dissemination of information.
(2) For purposes of paragraph (1), the term ``training''
does not include research training for which National Research
Service Awards \1\ may be provided under section 487.
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\1\ Now Ruth L. Kirschstein National Research Service Awards. See
section 487.
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(c) Support of a center under subsection (a) may be for a
period of not to exceed five years. Such period may be extended
by the Director for additional periods of not more than five
years each if the operations of such center have been reviewed
by an appropriate technical and scientific peer review group
established by the Director and if such group has recommended
to the Director that such period should be extended.
CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
Sec. 445A. [285e-3] (a) The Director of the Institute shall
enter into cooperative agreements with, and make grants to,
public and private nonprofit entities for the development or
expansion of not less than 10 centers of excellence in
geriatric research and training of researchers. Each such
center shall be known as a Claude D. Pepper Older Americans
Independence Center.
(b) Each center developed or expanded under this section
shall--
(1) utilize the facilities of a single institution,
or be formed from a consortium of cooperating
institutions, meeting such research and training
qualifications as may be prescribed by the Director;
and
(2) conduct--
(A) research into the aging processes and
into the diagnosis and treatment of diseases,
disorders, and complications related to aging,
including menopause, which research includes
research on such treatments, and on medical
devices and other medical interventions
regarding such diseases, disorders, and
complications, that can assist individuals in
avoiding institutionalization and prolonged
hospitalization and in otherwise increasing the
independence of the individuals; and
(B) programs to develop individuals capable
of conducting research described in
subparagraph (A).
(c) In making cooperative agreements and grants under this
section for the development or expansion of centers, the
Director of the Institute shall ensure that, to the extent
practicable, any such centers are distributed equitably among
the principal geographic regions of the United States.
(d) For purposes of this section, the term
``independence'', with respect to diseases, disorders, and
complications of aging, means the functional ability of
individuals to perform activities of daily living or
instrumental activities of daily living without assistance or
supervision.
awards authorized
Sec. 445B. \1\ [285e-4] (a) The Director of the Institute
shall make awards to senior researchers who have made
distinguished achievements in biomedical research in areas
relating to Alzheimer's disease and related dementias. Awards
under this section shall be used by the recipients to support
research in areas relating to such disease and dementias, and
may be used by the recipients to train junior researchers who
demonstrate exceptional promise to conduct research in such
areas.
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\1\ Sections 445B through 445F were originally enacted as
provisions of title IX of Public Law 99-660, and were transferred to
the Public Health Service Act by section 142 of Public Law 100-607.
(Various provisions relating to Alzheimer's disease remain in such
title IX, which is included in this compilation.)
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(b) The Director of the Institute may make awards under
this section to researchers at centers supported under section
445 and to researchers at other public and nonprofit private
entities.
(c) The Director of the Institute shall make awards under
this section only to researchers who have been recommended for
such awards by the National Advisory Council on Aging.
(d) The Director of the Institute shall establish
procedures for the selection of the recipients of awards under
this section.
(e) Awards under this section shall be made for a one-year
period, and may be renewed for not more than six additional
consecutive one-year periods.
research program and plan
Sec. 445C. [285e-5] (a) The Director of the Institute shall
conduct, or make grants for the conduct of, research relevant
to appropriate services for individuals with Alzheimer's
disease and related dementias and their families.
(b)(1) Within 6 months after the date of enactment of the
Alzheimer's Disease and Related Dementias Services Research Act
of 1986, the Director of the Institute shall prepare and
transmit to the Chairman of the Council on Alzheimer's Disease
(in this section referred to as the ``Council'') a plan for the
research to be conducted under subsection (a). The plan shall--
(A) provide for research concerning--
(i) the epidemiology of, and the
identification of risk factors for, Alzheimer's
disease and related dementias; and
(ii) the development and evaluation of
reliable and valid multidimensional diagnostic
and assessment procedures and instruments; and
(B) ensure that research carried out under the plan
is coordinated with, and uses, to the maximum extent
feasible, resources of, other Federal programs relating
to Alzheimer's disease and related dementias, including
centers supported under section 445, centers supported
by the National Institute of Mental Health on the
psychopathology of the elderly, relevant activities of
the Administration on Aging, other programs and centers
involved in research on Alzheimer's disease and related
dementias supported by the Department, and other
programs relating to Alzheimer's disease and related
dementias which are planned or conducted by Federal
agencies other than the Department, State or local
agencies, community organizations, or private
foundations.
(2) Within one year after transmitting the plan required
under paragraph (1), and annually thereafter, the Director of
the Institute shall prepare and transmit to the Chairman of the
Council such revisions of such plan as the Director considers
appropriate.
(c) In preparing and revising the plan required by
subsection (b), the Director of the Institute shall consult
with the Chairman of the Council and the heads of agencies
within the Department.
(d) the \1\ Director of the Institute may develop, or make
grants to develop--
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\1\ So in law. See section 9 of Public Law 102-507 (106 Stat.
3287). Probably should be ``The''.
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(1) model techniques to--
(A) promote greater independence, including
enhanced independence in performing activities
of daily living and instrumental activities of
daily living, for persons with Alzheimer's
disease and related disorders; and
(B) prevent or reduce the severity of
secondary disabilities, including confusional
episodes, falls, bladder and bowel
incontinence, and adverse effects of
prescription and over-the-counter medications,
in such persons; and
(2) model curricula for health care professionals,
health care paraprofessionals, and family caregivers,
for training and application in the use of such
techniques.
(e) For purposes of this section, the term ``Council on
Alzheimer's Disease'' means the council established in section
911(a) \2\ of Public Law 99-660.
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\2\ Section 911 was repealed by section 601(a)(2)(E) of Public Law
105-362 (112 Stat. 3286).
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dissemination
Sec. 445D. [285e-6] The Director of the Institute shall
disseminate the results of research conducted under section
445C and this section to appropriate professional entities and
to the public.
clearinghouse on alzheimer's disease
Sec. 445E. [285e-7] (a) The Director of the Institute shall
establish the Clearinghouse on Alzheimer's Disease (hereinafter
referred to as the ``Clearinghouse''). The purpose of the
Clearinghouse is the dissemination of information concerning
services available for individuals with Alzheimer's disease and
related dementias and their families. The Clearinghouse shall--
(1) compile, archive, and disseminate information
concerning research, demonstration, evaluation, and
training programs and projects concerning Alzheimer's
disease and related dementias; and
(2) annually publish a summary of the information
compiled under paragraph (1) during the preceding 12-
month period, and make such information available upon
request to appropriate individuals and entities,
including educational institutions, research entities,
and Federal and public agencies.
(b) The Clearinghouse may charge an appropriate fee for
information provided through the toll-free telephone line
established under subsection (a)(3). \1\
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\1\ So in law. Section 445E does not contain a subsection (a)(3).
Section 445F(b)(2) provides for a toll-free telephone line.
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(c) The Director of the Institute, the Director of the
National Institute of Mental Health, and the Director of the
National Center for Health Services Research and Health Care
Technology Assessment shall provide to the Clearinghouse
summaries of the findings of research conducted under part D.
dissemination project
Sec. 445F. [285e-8] (a) The Director of the Institute shall
make a grant to, or enter into a contract with, a national
organization representing individuals with Alzheimer's disease
and related dementias for the conduct of the activities
described in subsection (b).
(b) The organization receiving a grant or contract under
this section shall--
(1) establish a central computerized information
system to--
(A) compile and disseminate information
concerning initiatives by State and local
governments and private entities to provide
programs and services for individuals with
Alzheimer's disease and related dementias; and
(B) translate scientific and technical
information concerning such initiatives into
information readily understandable by the
general public, and make such information
available upon request; and
(2) establish a national toll-free telephone line
to make available the information described in
paragraph (1), and information concerning Federal
programs, services and benefits for individuals with
Alzheimer's disease and related dementias and their
families.
(c) The organization receiving a grant or contract under
this section may charge appropriate fees for information
provided through the toll-free telephone line established under
subsection (b)(2), and may make exceptions to such fees for
individuals and organizations who are not financially able to
pay such fees.
(d) In order to receive a grant or contract under this
section, an organization shall submit an application to the
Director of the Institute. Such application shall contain--
(1) information demonstrating that such
organization has a network of contacts which will
enable such organization to receive information
necessary to the operation of the central computerized
information system described in subsection (b)(1);
(2) information demonstrating that, by the end of
fiscal year 1991, such organization will be financially
able to, and will, carry out the activities described
in subsection (b) without a grant or contract from the
Federal Government; and
(3) such other information as the Director may
prescribe.
h3 deg.alzheimer's disease registry
Sec. 445G. [285e-9] (a) In General.--The Director of the
Institute may make a grant to develop a registry for the
collection of epidemiological data about Alzheimer's disease
and its incidence in the United States, to train personnel in
the collection of such data, and for other matters respecting
such disease.
(b) Qualifications.--To qualify for a grant under
subsection (a) an applicant shall--
(1) be an accredited school of medicine or public
health which has expertise in the collection of
epidemiological data about individuals with Alzheimer's
disease and in the development of disease registries,
and
(2) have access to a large patient population,
including a patient population representative of
diverse ethnic backgrounds.
aging processes regarding women
Sec. 445H. [285e-10] The Director of the Institute, in
addition to other special functions specified in section 444
and in cooperation with the Directors of the other national
research institutes and agencies of the National Institutes of
Health, shall conduct research into the aging processes of
women, with particular emphasis given to the effects of
menopause and the physiological and behavioral changes
occurring during the transition from pre- to post-menopause,
and into the diagnosis, disorders, and complications related to
aging and loss of ovarian hormones in women.
SEC. 445I. [285E-10A] ALZHEIMER'S CLINICAL RESEARCH AND TRAINING
AWARDS.
(a) In General.--The Director of the Institute is
authorized to establish and maintain a program to enhance and
promote the translation of new scientific knowledge into
clinical practice related to the diagnosis, care and treatment
of individuals with Alzheimer's disease.
(b) Support of Promising Clinicians.--In order to foster
the application of the most current developments in the
etiology, pathogenesis, diagnosis, prevention and treatment of
Alzheimer's disease, amounts made available under this section
shall be directed to the support of promising clinicians
through awards for research, study, and practice at centers of
excellence in Alzheimer's disease research and treatment.
(c) Excellence in Certain Fields.--Research shall be
carried out under awards made under subsection (b) in
environments of demonstrated excellence in neuroscience,
neurobiology, geriatric medicine, and psychiatry and shall
foster innovation and integration of such disciplines or other
environments determined suitable by the Director of the
Institute.
Subpart 6--National Institute of Allergy and Infectious Diseases
purpose of the institute
Sec. 446. [285f] The general purpose of the National
Institute of Allergy and Infectious Diseases is the conduct and
support of research, training, health information
dissemination, and other programs with respect to allergic and
immunologic diseases and disorders and infectious diseases,
including tropical diseases.
research centers regarding chronic fatigue syndrome
Sec. 447. [285f-1] (a) The Director of the Institute, after
consultation with the advisory council for the Institute, may
make grants to, or enter into contracts with, public or
nonprofit private entities for the development and operation of
centers to conduct basic and clinical research on chronic
fatigue syndrome.
(b) Each center assisted under this section shall use the
facilities of a single institution, or be formed from a
consortium of cooperating institutions, meeting such
requirements as may be prescribed by the Director of the
Institute.
research and research training regarding tuberculosis
Sec. 447A. [285f-2] In carrying out section 446, the
Director of the Institute shall conduct or support research and
research training regarding the cause, diagnosis, early
detection, prevention and treatment of tuberculosis.
SEC. 447B. [285F-3] SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND
TRAINING AWARDS.
(a) In General.--The Director of the Institute is
authorized to establish and maintain a program to enhance and
promote the translation of new scientific knowledge into
clinical practice related to the diagnosis, care and treatment
of individuals with sexually transmitted diseases.
(b) Support of Promising Clinicians.--In order to foster
the application of the most current developments in the
etiology, pathogenesis, diagnosis, prevention and treatment of
sexually transmitted diseases, amounts made available under
this section shall be directed to the support of promising
clinicians through awards for research, study, and practice at
centers of excellence in sexually transmitted disease research
and treatment.
(c) Excellence in Certain Fields.--Research shall be
carried out under awards made under subsection (b) in
environments of demonstrated excellence in the etiology and
pathogenesis of sexually transmitted diseases and shall foster
innovation and integration of such disciplines or other
environments determined suitable by the Director of the
Institute.
SEC. 447C. [285F-4] MICROBICIDE RESEARCH AND DEVELOPMENT.
The Director of the Institute, acting through the head of
the Division of AIDS, shall, consistent with the peer-review
process of the National Institutes of Health, carry out
research on, and development of, safe and effective methods for
use by women to prevent the transmission of the human
immunodeficiency virus, which may include microbicides.
Subpart 7--Eunice Kennedy Shriver National Institute of Child Health
and Human Development \1\
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\1\ Section 1004 of Public Law 106-310 (114 Stat. 1130) authorizes
the Director of the Institute to conduct a national longitudinal study
of environmental influences (including physical, chemical, biological,
and psychosocial) on children's health and development. Subsection (d)
of such section requires periodic reports to the Congress regarding the
study. The first report is required to be submitted not later than
three years after the date of the enactment of the Public Law, which
was enacted October 17, 2000.
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purpose of the institute
Sec. 448. [285g] The general purpose of the National
Institute of Child Health and Human Development \1\ (hereafter
in this subpart referred to as the ``Institute'') is the
conduct and support of research, training, health information
dissemination, and other programs with respect to gynecologic
health, maternal health, child health, mental retardation,
human growth and development, including prenatal development,
population research, and special health problems and
requirements of mothers and children.
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\1\ The probable intent of the Congress is to refer to the ``Eunice
Kennedy Shriver National Institute of Child Health and Human
Development''. Section 1(b)(7) of Public Law 110-154 (121 Stat 1827)
struck the term ``National Institute of Child Health and Human
Development'' and inserted ``Eunice Kennedy Shriver National Institute
of Child Health and Human Development'' each place such term appeared
in the heading of subpart 7 of part C of title IV, but not in the text
of section 448.
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sudden infant death syndrome
Sec. 449. [285g-1] The Director of the Institute shall
conduct and support research which specifically relates to
sudden infant death syndrome.
mental retardation research
Sec. 450. [285g-2] The Director of the Institute shall
conduct and support research and related activities into the
causes, prevention, and treatment of mental retardation.
associate director for prevention
Sec. 451. [285g-3] There shall be in the Institute an
Associate Director for Prevention to coordinate and promote the
programs in the Institute concerning the prevention of health
problems of mothers and children. The Associate Director shall
be appointed by the Director of the Institute from individuals
who because of their professional training or experience are
experts in public health or preventive medicine.
national center for medical rehabilitation research
Sec. 452. [285g-4] (a) There shall be in the Institute an
agency to be known as the National Center for Medical
Rehabilitation Research (hereafter in this section referred to
as the ``Center'') \1\. The Director of the Institute shall
appoint a qualified individual to serve as Director of the
Center. The Director of the Center shall report directly to the
Director of the Institute.
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\1\ Section 3(b) of Public Law 101-613 requires that Federal
agencies, as appropriate, enter into agreements for preventing
duplication among Federal programs regarding medical rehabilitation.
Such section requires that the agreements be made not later than one
year after the date of the enactment of the Public Law, which was
enacted November 16, 1990.
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(b) The general purpose of the Center is the conduct and
support of research and research training (including research
on the development of orthotic and prosthetic devices), the
dissemination of health information, and other programs with
respect to the rehabilitation of individuals with physical
disabilities resulting from diseases or disorders of the
neurological, musculoskeletal, cardiovascular, pulmonary, or
any other physiological system (hereafter in this section
referred to as ``medical rehabilitation'').
(c)(1) In carrying out the purpose described in subsection
(b), the Director of the Center may--
(A) provide for clinical trials regarding medical
rehabilitation;
(B) provide for research regarding model systems of
medical rehabilitation;
(C) coordinate the activities of the Center with
similar activities of other agencies of the Federal
Government, including the other agencies of the
National Institutes of Health, and with similar
activities of other public entities and of private
entities;
(D) support multidisciplinary medical
rehabilitation research conducted or supported by more
than one such agency;
(E) in consultation with the advisory council for
the Institute and with the approval of the Director of
NIH--
(i) establish technical and scientific peer
review groups in addition to those appointed
under section 402(b)(16); and
(ii) appoint the members of peer review
groups established under subparagraph (A); and
(F) support medical rehabilitation research and
training centers.
The Federal Advisory Committee Act shall not apply to the
duration of a peer review group appointed under subparagraph
(E).
(2) In carrying out this section, the Director of the
Center may make grants and enter into cooperative agreements
and contracts.
(d)(1) In consultation with the Director of the Center, the
coordinating committee established under subsection (e), and
the advisory board established under subsection (f), the
Director of the Institute shall develop a comprehensive plan
for the conduct and support of medical rehabilitation research
(hereafter in this section referred to as the ``Research
Plan'').
(2) The Research Plan shall--
(A) identify current medical rehabilitation
research activities conducted or supported by the
Federal Government, opportunities and needs for
additional research, and priorities for such research;
and
(B) make recommendations for the coordination of
such research conducted or supported by the National
Institutes of Health and other agencies of the Federal
Government.
(3)(A) Not later than 18 months after the date of the
enactment of the National Institutes of Health Revitalization
Amendments of 1990, \1\ the Director of the Institute shall
transmit the Research Plan to the Director of NIH, who shall
submit the Plan to the President and the Congress.
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\1\ So in law. No Act with such a short title was enacted during
1990. The probable intent of the Congress was to make a reference to
Public Law 101-613, the National Institutes of Health Amendments of
1990, which added section 452 and which was enacted November 16, 1990.
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(B) Subparagraph (A) shall be carried out independently of
the process of reporting that is required in sections 403 and
407.
(4) The Director of the Institute shall periodically revise
and update the Research Plan as appropriate, after consultation
with the Director of the Center, the coordinating committee
established under subsection (e), and the advisory board
established under subsection (f). A description of any
revisions in the Research Plan shall be contained in each
report prepared under section 407 by the Director of the
Institute.
(e)(1) The Director of NIH shall establish a committee to
be known as the Medical Rehabilitation Coordinating Committee
(hereafter in this section referred to as the ``Coordinating
Committee'').
(2) The Coordinating Committee shall make recommendations
to the Director of the Institute and the Director of the Center
with respect to the content of the Research Plan and with
respect to the activities of the Center that are carried out in
conjunction with other agencies of the National Institutes of
Health and with other agencies of the Federal Government.
(3) The Coordinating Committee shall be composed of the
Director of the Center, the Director of the Institute, and the
Directors of the National Institute on Aging, the National
Institute of Arthritis and Musculoskeletal and Skin Diseases,
the National Heart, Lung, and Blood Institute, the National
Institute of Neurological Disorders and Stroke, and such other
national research institutes and such representatives of other
agencies of the Federal Government as the Director of NIH
determines to be appropriate.
(4) The Coordinating Committee shall be chaired by the
Director of the Center.
(f)(1) Not later than 90 days after the date of the
enactment of the National Institutes of Health Revitalization
Amendments of 1990, \1\ the Director of NIH shall establish a
National Advisory Board on Medical Rehabilitation Research
(hereafter in this section referred to as the ``Advisory
Board'').
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\1\ See footnote for subsection (d)(3)(A).
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(2) The Advisory Board shall review and assess Federal
research priorities, activities, and findings regarding medical
rehabilitation research, and shall advise the Director of the
Center and the Director of the Institute on the provisions of
the Research Plan.
(3)(A) The Director of NIH shall appoint to the Advisory
Board 18 qualified representatives of the public who are not
officers or employees of the Federal Government. Of such
members, 12 shall be representatives of health and scientific
disciplines with respect to medical rehabilitation and 6 shall
be individuals representing the interests of individuals
undergoing, or in need of, medical rehabilitation.
(B) The following officials shall serve as ex officio
members of the Advisory Board:
(i) The Director of the Center.
(ii) The Director of the Institute.
(iii) The Director of the National Institute on
Aging.
(iv) The Director of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases.
(v) The Director of the National Institute on
Deafness and Other Communication Disorders.
(vi) The Director of the National Heart, Lung, and
Blood Institute.
(vii) The Director of the National Institute of
Neurological Disorders and Stroke.
(viii) The Director of the National Institute on
Disability and Rehabilitation Research.
(ix) The Commissioner for Rehabilitation Services
Administration.
(x) The Assistant Secretary of Defense (Health
Affairs).
(xi) The Chief Medical Director of the Department
of Veterans Affairs.
(4) The members of the Advisory Board shall, from among the
members appointed under paragraph (3)(A), designate an
individual to serve as the chair of the Advisory Board.
h3 deg.research centers with respect to contraception and
infertility
Sec. 452A. [285g-5] (a) The Director of the Institute,
after consultation with the advisory council for the Institute,
shall make grants to, or enter into contracts with, public or
nonprofit private entities for the development and operation of
centers to conduct activities for the purpose of improving
methods of contraception and centers to conduct activities for
the purpose of improving methods of diagnosis and treatment of
infertility.
(b) In carrying out subsection (a), the Director of the
Institute shall, subject to the extent of amounts made
available in appropriations Acts, provide for the establishment
of three centers with respect to contraception and for two
centers with respect to infertility.
(c)(1) Each center assisted under this section shall, in
carrying out the purpose of the center involved--
(A) conduct clinical and other applied research,
including--
(i) for centers with respect to
contraception, clinical trials of new or
improved drugs and devices for use by males and
females (including barrier methods); and
(ii) for centers with respect to
infertility, clinical trials of new or improved
drugs and devices for the diagnosis and
treatment of infertility in males and females;
(B) develop protocols for training physicians,
scientists, nurses, and other health and allied health
professionals;
(C) conduct training programs for such individuals;
(D) develop model continuing education programs for
such professionals; and
(E) disseminate information to such professionals
and the public.
(2) A center may use funds provided under subsection (a) to
provide stipends for health and allied health professionals
enrolled in programs described in subparagraph (C) of paragraph
(1), and to provide fees to individuals serving as subjects in
clinical trials conducted under such paragraph.
(d) The Director of the Institute shall, as appropriate,
provide for the coordination of information among the centers
assisted under this section.
(e) Each center assisted under subsection (a) shall use the
facilities of a single institution, or be formed from a
consortium of cooperating institutions, meeting such
requirements as may be prescribed by the Director of the
Institute.
(f) Support of a center under subsection (a) may be for a
period not exceeding 5 years. Such period may be extended for
one or more additional periods not exceeding 5 years if the
operations of such center have been reviewed by an appropriate
technical and scientific peer review group established by the
Director and if such group has recommended to the Director that
such period should be extended.
h3 deg.program regarding obstetrics and gynecology
Sec. 452B. [285g-6] The Director of the Institute shall
establish and maintain within the Institute an intramural
laboratory and clinical research program in obstetrics and
gynecology.
h3 deg.child health research centers
Sec. 452C. [285g-7] The Director of the Institute shall
develop and support centers for conducting research with
respect to child health. Such centers shall give priority to
the expeditious transfer of advances from basic science to
clinical applications and improving the care of infants and
children.
prospective longitudinal study on adolescent health
Sec. 452D. [285g-8] (a) In General.--Not later than October
1, 1993, the Director of the Institute shall commence a study
for the purpose of providing information on the general health
and well-being of adolescents in the United States, including,
with respect to such adolescents, information on--
(1) the behaviors that promote health and the
behaviors that are detrimental to health; and
(2) the influence on health of factors particular
to the communities in which the adolescents reside.
(b) Design of Study.--
(1) In general.--The study required in subsection
(a) shall be a longitudinal study in which a
substantial number of adolescents participate as
subjects. With respect to the purpose described in such
subsection, the study shall monitor the subjects
throughout the period of the study to determine the
health status of the subjects and any change in such
status over time.
(2) Population-specific analyses.--The study
required in subsection (a) shall be conducted with
respect to the population of adolescents who are
female, the population of adolescents who are male,
various socioeconomic populations of adolescents, and
various racial and ethnic populations of adolescents.
The study shall be designed and conducted in a manner
sufficient to provide for a valid analysis of whether
there are significant differences among such
populations in health status and whether and to what
extent any such differences are due to factors
particular to the populations involved.
(c) Coordination With Women's Health Initiative.--With
respect to the national study of women being conducted by the
Secretary and known as the Women's Health Initiative, the
Secretary shall ensure that such study is coordinated with the
component of the study required in subsection (a) that concerns
adolescent females, including coordination in the design of the
2 studies.
fragile x
Sec. 452E. [285g-9] (a) Expansion and Coordination of
Research Activities.--The Director of the Institute, after
consultation with the advisory council for the Institute, shall
expand, intensify, and coordinate the activities of the
Institute with respect to research on the disease known as
fragile X.
(b) Research Centers.--
(1) In general.--The Director of the Institute
shall make grants or enter into contracts for the
development and operation of centers to conduct
research for the purposes of improving the diagnosis
and treatment of, and finding the cure for, fragile X.
(2) Number of centers.--
(A) In general.--In carrying out paragraph
(1), the Director of the Institute shall, to
the extent that amounts are appropriated, and
subject to subparagraph (B), provide for the
establishment of at least three fragile X
research centers.
(B) Peer review requirement.--The Director
of the Institute shall make a grant to, or
enter into a contract with, an entity for
purposes of establishing a center under
paragraph (1) only if the grant or contract has
been recommended after technical and scientific
peer review required by regulations under
section 492.
(3) Activities.--The Director of the Institute,
with the assistance of centers established under
paragraph (1), shall conduct and support basic and
biomedical research into the detection and treatment of
fragile X.
(4) Coordination among centers.--The Director of
the Institute shall, as appropriate, provide for the
coordination of the activities of the centers assisted
under this section, including providing for the
exchange of information among the centers.
(5) Certain administrative requirements.--Each
center assisted under paragraph (1) shall use the
facilities of a single institution, or be formed from a
consortium of cooperating institutions, meeting such
requirements as may be prescribed by the Director of
the Institute.
(6) Duration of support.--Support may be provided
to a center under paragraph (1) for a period not
exceeding 5 years. Such period may be extended for one
or more additional periods, each of which may not
exceed 5 years, if the operations of such center have
been reviewed by an appropriate technical and
scientific peer review group established by the
Director and if such group has recommended to the
Director that such period be extended.
investment in tomorrow's pediatric researchers
Sec. 452G. \1\ [285g-10] In order to ensure the future
supply of researchers dedicated to the care and research needs
of children, the Director of the Institute, after consultation
with the Administrator of the Health Resources and Services
Administration, shall support activities to provide for--
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\1\So in law. Probably should be ``Sec. 452F.''. See amendments
made by sections 201 and 1002 of Public Law 106-310 (114 Stat. 1109,
1128). (In amending this subpart to add section 452G above, such
section 1002 made a reference to this subpart ``as amended by section
921'' of Public Law 106-310, but no section 921 appeared in the Public
Law.)
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(1) an increase in the number and size of
institutional training grants to institutions
supporting pediatric training; and
(2) an increase in the number of career development
awards for health professionals who intend to build
careers in pediatric basic and clinical research,
including pediatric pharmacological research.
Subpart 8--National Institute of Dental Research \1\
purpose of the institute
Sec. 453. [285h] The general purpose of the National
Institute of Dental Research \1\ is the conduct and support of
research, training, health information dissemination, and other
programs with respect to the cause, prevention, and methods of
diagnosis and treatment of dental and oral diseases and
conditions.
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\1\See footnote for section 401(b)(1)(H).
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Subpart 9--National Eye Institute
purpose of the institute
Sec. 455. [285i] The general purpose of the National Eye
Institute (hereafter in this subpart referred to as the
``Institute'') is the conduct and support of research,
training, health information dissemination, and other programs
with respect to blinding eye diseases, visual disorders,
mechanisms of visual function, preservation of sight, and the
special health problems and requirements of the blind. Subject
to section 456, the Director of the Institute may carry out a
program of grants for public and private nonprofit vision
research facilities.
clinical research on eye care and diabetes
Sec. 456. [285i-1] (a) Program of Grants.--The Director of
the Institute, in consultation with the advisory council for
the Institute, may award research grants to one or more
Diabetes Eye Research Institutions for the support of programs
in clinical or health services aimed at--
(1) providing comprehensive eye care services for
people with diabetes, including a full complement of
preventive, diagnostic and treatment procedures;
(2) developing new and improved techniques of
patient care through basic and clinical research;
(3) assisting in translation of the latest research
advances into clinical practice; and
(4) expanding the knowledge of the eye and diabetes
through further research.
(b) Use of Funds.--Amounts received under a grant awarded
under this section shall be used for the following:
(1) Establishing the biochemical, cellular, and
genetic mechanisms associated with diabetic eye disease
and the earlier detection of pending eye abnormalities.
The focus of work under this paragraph shall require
that ophthalmologists have training in the most up-to-
date molecular and cell biological methods.
(2) Establishing new frontiers in technology, such
as video-based diagnostic and research resources, to--
(A) provide improved patient care;
(B) provide for the evaluation of retinal
physiology and its affect on diabetes; and
(C) provide for the assessment of risks for
the development and progression of diabetic eye
disease and a more immediate evaluation of
various therapies aimed at preventing diabetic
eye disease.
Such technologies shall be designed to permit
evaluations to be performed both in humans and in
animal models.
(3) The translation of the results of vision
research into the improved care of patients with
diabetic eye disease. Such translation shall require
the application of institutional resources that
encompass patient care, clinical research and basic
laboratory research.
(4) The conduct of research concerning the outcomes
of eye care treatments and eye health education
programs as they relate to patients with diabetic eye
disease, including the evaluation of regional
approaches to such research.
(c) Authorized Expenditures.--The purposes for which a
grant under subsection (a) may be expended include equipment
for the research described in such subsection.
Subpart 10--National Institute of Neurological Disorders and Stroke
purpose of the institute
Sec. 457. [285j] The general purpose of the National
Institute of Neurological Disorders and Stroke (hereafter in
this subpart referred to as the ``Institute'') is the conduct
and support of research, training, health information
dissemination, and other programs with respect to neurological
disease and disorder and stroke.
spinal cord regeneration research
Sec. 458. [285j-1] The Director of the Institute shall
conduct and support research into spinal cord regeneration.
bioengineering research
Sec. 459. [285j-2] The Director of the Institute shall make
grants or enter into contracts for research on the means to
overcome paralysis of the extremities through electrical
stimulation and the use of computers.
h3 deg.research on multiple sclerosis
Sec. 460. [285j-3] The Director of the Institute shall
conduct and support research on multiple sclerosis, especially
research on effects of genetics and hormonal changes on the
progress of the disease.
Subpart 11--National Institute of General Medical Sciences
purpose of the institute
Sec. 461. [285k] The general purpose of the National
Institute of General Medical Sciences is the conduct and
support of research, training, and, as appropriate, health
information dissemination, and other programs with respect to
general or basic medical sciences and related natural or
behavioral sciences which have significance for two or more
other national research institutes or are outside the general
area of responsibility of any other national research
institute.
Subpart 12--National Institute of Environmental Health Sciences
purpose of the institute
Sec. 463. [285l] The general purpose of the National
Institute of Environmental Health Sciences (in this subpart
referred to as the ``Institute'') is the conduct and support of
research, training, health information dissemination, and other
programs with respect to factors in the environment that affect
human health, directly or indirectly.
h3 deg.applied toxicological research and testing program
Sec. 463A. [285l-1] (a) There is established within the
Institute a program for conducting applied research and testing
regarding toxicology, which program shall be known as the
Applied Toxicological Research and Testing Program.
(b) In carrying out the program established under
subsection (a), the Director of the Institute shall, with
respect to toxicology, carry out activities--
(1) to expand knowledge of the health effects of
environmental agents;
(2) to broaden the spectrum of toxicology
information that is obtained on selected chemicals;
(3) to develop and validate assays and protocols,
including alternative methods that can reduce or
eliminate the use of animals in acute or chronic safety
testing;
(4) to establish criteria for the validation and
regulatory acceptance of alternative testing and to
recommend a process through which scientifically
validated alternative methods can be accepted for
regulatory use;
(5) to communicate the results of research to
government agencies, to medical, scientific, and
regulatory communities, and to the public; and
(6) to integrate related activities of the
Department of Health and Human Services.
methods of controlling certain insect and vermin populations
Sec. 463B. [285l-6] The Director of the Institute shall
conduct or support research to identify or develop methods of
controlling insect and vermin populations that transmit to
humans diseases that have significant adverse health
consequences.
H2 deg.Subpart 13--National Institute on Deafness and Other
Communication Disorders
h3 deg.purpose of the institute
Sec. 464. [285m] The general purpose of the National
Institute on Deafness and Other Communication Disorders
(hereafter referred to in this subpart as the ``Institute'') is
the conduct and support of research and training, the
dissemination of health information, and other programs with
respect to disorders of hearing and other communication
processes, including diseases affecting hearing, balance,
voice, speech, language, taste, and smell.
h3 deg.national deafness and other communication disorders
program
Sec. 464A. [285m-1] (a) The Director of the Institute, with
the advice of the Institute's advisory council, shall establish
a National Deafness and Other Communication Disorders Program
(hereafter in this section referred to as the ``Program''). The
Director or \1\ the Institute shall, with respect to the
Program, prepare and transmit to the Director of NIH a plan to
initiate, expand, intensify and coordinate activities of the
Institute respecting disorders of hearing (including tinnitus)
and other communication processes, including diseases affecting
hearing, balance, voice, speech, language, taste, and smell.
The plan shall include such comments and recommendations as the
Director of the Institute determines appropriate. The Director
of the Institute shall periodically review and revise the plan
and shall transmit any revisions of the plan to the Director of
NIH.
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\1\ So in law. See section 2(4) of Public Law 100-553 (102 Stat.
2769). Probably should be ``Director of''.
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(b) Activities under the Program shall include--
(1) investigation into the etiology, pathology,
detection, treatment, and prevention of all forms of
disorders of hearing and other communication processes,
primarily through the support of basic research in such
areas as anatomy, audiology, biochemistry,
bioengineering, epidemiology, genetics, immunology,
microbiology, molecular biology, the neurosciences,
otolaryngology, psychology, pharmacology, physiology,
speech and language pathology, and any other scientific
disciplines that can contribute important knowledge to
the understanding and elimination of disorders of
hearing and other communication processes;
(2) research into the evaluation of techniques
(including surgical, medical, and behavioral
approaches) and devices (including hearing aids,
implanted auditory and nonauditory prosthetic devices
and other communication aids) used in diagnosis,
treatment, rehabilitation, and prevention of disorders
of hearing and other communication processes;
(3) research into prevention, and early detection
and diagnosis, of hearing loss and speech and language
disturbances (including stuttering) and research into
preventing the effects of such disorders on learning
and learning disabilities with extension of programs
for appropriate referral and rehabilitation;
(4) research into the detection, treatment, and
prevention of disorders of hearing and other
communication processes in the growing elderly
population with extension of rehabilitative programs to
ensure continued effective communication skills in such
population;
(5) research to expand knowledge of the effects of
environmental agents that influence hearing or other
communication processes; and
(6) developing and facilitating intramural programs
on clinical and fundamental aspects of disorders of
hearing and all other communication processes.
h3 deg.data system and information clearinghouse
Sec. 464B. [285m-2] (a) The Director of the Institute shall
establish a National Deafness and Other Communication Disorders
Data System for the collection, storage, analysis, retrieval,
and dissemination of data derived from patient populations with
disorders of hearing or other communication processes,
including where possible, data involving general populations
for the purpose of identifying individuals at risk of
developing such disorders.
(b) The Director of the Institute shall establish a
National Deafness and Other Communication Disorders Information
Clearinghouse to facilitate and enhance, through the effective
dissemination of information, knowledge and understanding of
disorders of hearing and other communication processes by
health professionals, patients, industry, and the public.
h3 deg.multipurpose deafness and other communication
disorders center
Sec. 464C. [285m-3] (a) The Director of the Institute
shall, after consultation with the advisory council for the
Institute, provide for the development, modernization, and
operation (including care required for research) of new and
existing centers for studies of disorders of hearing and other
communication processes. For purposes of this section, the term
``modernization'' means the alteration, remodeling,
improvement, expansion, and repair of existing buildings and
the provision of equipment for such buildings to the extent
necessary to make them suitable for use as centers described in
the preceding sentence.
(b) Each center assisted under this section shall--
(1) use the facilities of a single institution or a
consortium of cooperating institutions; and
(2) meet such qualifications as may be prescribed
by the Secretary.
(c) Each center assisted under this section shall, at
least, conduct--
(1) basic and clinical research into the cause
diagnosis, early detection, prevention, control and
treatment of disorders of hearing and other
communication processes and complications resulting
from such disorders, including research into
rehabilitative aids, implantable biomaterials, auditory
speech processors, speech production devices, and other
otolaryngologic procedures;
(2) training programs for physicians, scientists,
and other health and allied health professionals;
(3) information and continuing education programs
for physicians and other health and allied health
professionals who will provide care for patients with
disorders of hearing or other communication processes;
and
(4) programs for the dissemination to the general
public of information--
(A) on the importance of early detection of
disorders of hearing and other communication
processes, of seeking prompt treatment,
rehabilitation, and of following an appropriate
regimen; and
(B) on the importance of avoiding exposure
to noise and other environmental toxic agents
that may affect disorders of hearing or other
communication processes.
(d) A center may use funds provided under subsection (a) to
provide stipends for health professionals enrolled in training
programs described in subsection (c)(2).
(e) Each center assisted under this section may conduct
programs--
(1) to establish the effectiveness of new and
improved methods of detection, referral, and diagnosis
of individuals at risk of developing disorders of
hearing or other communication processes; and
(2) to disseminate the results of research,
screening, and other activities, and develop means of
standardizing patient data and recordkeeping.
(f) The Director of the Institute shall, to the extent
practicable, provide for an equitable geographical distribution
of centers assisted under this section. The Director shall give
appropriate consideration to the need for centers especially
suited to meeting the needs of the elderly, and of children
(particularly with respect to their education and training),
affected by disorders of hearing or other communication
processes.
(g) Support of a center under this section may be for a
period not to exceed seven years. Such period may be extended
by the Director of the Institute for one or more additional
periods of not more than five years if the operations of such
center have been reviewed by an appropriate technical and
scientific peer review group established by the Director, with
the advice of the Institute's advisory council, if such group
has recommended to the Director that such period should be
extended.
national institute on deafness and other communication disorders
advisory board
Sec. 464D. [285m-4] (a) The Secretary shall establish in
the Institute the National Deafness and Other Communications
Disorders Advisory Board (hereafter in this section referred to
as the ``Advisory Board'').
(b) The Advisory Board shall be composed of eighteen
appointed members and nonvoting ex officio members as follows:
(1) The Secretary shall appoint--
(A) twelve members from individuals who are
scientists, physicians, and other health and
rehabilitation professionals, who are not
officers or employees of the United States, and
who represent the specialties and disciplines
relevant to deafness and other communication
disorders, including not less than two persons
with a communication disorder; and
(B) six members from the general public who
are knowledgeable with respect to such
disorders, including not less than one person
with a communication disorder and not less than
one person who is a parent of an individual
with such a disorder.
Of the appointed members, not less than five shall by
virtue of training or experience be knowledgeable in
diagnoses and rehabilitation of communication
disorders, education of the hearing, speech, or
language impaired, public health, public information,
community program development, occupational hazards to
communications senses, or the aging process.
(2) The following shall be ex officio members of
each Advisory Board:
(A) The Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute on Deafness and Other Communication
Disorders, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs, and the Assistant Secretary of Defense
for Health Affairs (or the designees of such
officers).
(B) Such other officers and employees of
the United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
(c) Members of an Advisory Board who are officers or
employees of the Federal Government shall serve as members of
the Advisory Board without compensation in addition to that
received in their regular public employment. Other members of
the Board shall receive compensation at rates not to exceed the
daily equivalent of the annual rate in effect for grade GS-18
of the General Schedule for each day (including traveltime)
they are engaged in the performance of their duties as members
of the Board.
(d) The term of office of an appointed member of the
Advisory Board is four years, except that no term of office may
extend beyond the expiration of the Advisory Board. Any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term. A member may serve
after the expiration of the member's term until a successor has
taken office. If a vacancy occurs in the Advisory Board, the
Secretary shall make an appointment to fill the vacancy not
later than 90 days from the date the vacancy occurred.
(e) The members of the Advisory Board shall select a
chairman from among the appointed members.
(f) The Secretary shall, after consultation with and
consideration of the recommendations of the Advisory Board,
provide the Advisory Board with an executive director and one
other professional staff member. In addition, the Secretary
shall, after consultation with and consideration of the
recommendations of the Advisory Board, provide the Advisory
Board with such additional professional staff members, such
clerical staff members, such services of consultants, such
information, and (through contracts or other arrangements) such
administrative support services and facilities, as the
Secretary determines are necessary for the Advisory Board to
carry out its functions.
(g) The Advisory Board shall meet at the call of the
chairman or upon request of the Director of the Institute, but
not less often than four times a year.
(h) The Advisory Board shall--
(1) review and evaluate the implementation of the
plan prepared under section 464A(a) and periodically
update the plan to ensure its continuing relevance;
(2) for the purpose of assuring the most effective
use and organization of resources respecting deafness
and other communication disorders, advise and make
recommendations to the Congress, the Secretary, the
Director of NIH, the Director of the Institute, and the
heads of other appropriate Federal agencies for the
implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies
related to Federal agencies involved in the
implementation of such plan and with key non-Federal
entities involved in activities affecting the control
of such disorders.
(i) In carrying out its functions, the Advisory Board may
establish subcommittees, convene workshops and conferences, and
collect data. Such subcommittees may be composed of Advisory
Board members and nonmember consultants with expertise in the
particular area addressed by such subcommittees. The
subcommittees may hold such meetings as are necessary to enable
them to carry out their activities.
(k) \1\ The National Deafness and Other Communication
Disorders Advisory Board shall be established not later than
April 1, 1989.
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\1\ So in law. There is no subsection (j) in section 464D.
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interagency coordinating committee
Sec. 464E. [285m-5] (a) The Secretary may establish a
committee to be known as the Deafness and Other Communication
Disorders Interagency Coordinating Committee (hereafter in this
section referred to as the ``Coordinating Committee'').
(b) The Coordinating Committee shall, with respect to
deafness and other communication disorders--
(1) provide for the coordination of the activities
of the national research institutes; and
(2) coordinate the aspects of all Federal health
programs and activities relating to deafness and other
communication disorders in order to assure the adequacy
and technical soundness of such programs and activities
and in order to provide for the full communication and
exchange of information necessary to maintain adequate
coordination of such programs and activities.
(c) The Coordinating Committee shall be composed of the
directors of each of the national research institutes and
divisions involved in research with respect to deafness and
other communication disorders and representatives of all other
Federal departments and agencies whose programs involve health
functions or responsibilities relevant to deafness and other
communication disorders.
(d) The Coordinating Committee shall be chaired by the
Director of NIH (or the designee of the Director). The
Committee shall meet at the call of the chair, but not less
often than four times a year.
limitation on administrative expenses
Sec. 464F. [285m-6] With respect to amounts appropriated
for a fiscal year for the National Institutes of Health, the
limitation established in section 408(a)(1) on the expenditure
of such amounts for administrative expenses shall apply to
administrative expenses of the National Institute on Deafness
and Other Communication Disorders.
Subpart 14--National Institute on Alcohol Abuse and Alcoholism
purpose of institute
Sec. 464H. [285n] (a) In General.--The general purpose of
the National Institute on Alcohol Abuse and Alcoholism
(hereafter in this subpart referred to as the ``Institute'') is
the conduct and support of biomedical and behavioral research,
health services research, research training, and health
information dissemination with respect to the prevention of
alcohol abuse and the treatment of alcoholism.
(b) Research Program.--The research program established
under this subpart shall encompass the social, behavioral, and
biomedical etiology, mental and physical health consequences,
and social and economic consequences of alcohol abuse and
alcoholism. In carrying out the program, the Director of the
Institute is authorized to--
(1) collect and disseminate through publications
and other appropriate means (including the development
of curriculum materials), information as to, and the
practical application of, the research and other
activities under the program;
(2) make available research facilities of the
Public Health Service to appropriate public
authorities, and to health officials and scientists
engaged in special study;
(3) make grants to universities, hospitals,
laboratories, and other public or nonprofit
institutions, and to individuals for such research
projects as are recommended by the National Advisory
Council on Alcohol Abuse and Alcoholism, giving special
consideration to projects relating to--
(A) the relationship between alcohol abuse
and domestic violence,
(B) the effects of alcohol use during
pregnancy,
(C) the impact of alcoholism and alcohol
abuse on the family, the workplace, and systems
for the delivery of health services,
(D) the relationship between the abuse of
alcohol and other drugs,
(E) the effect on the incidence of alcohol
abuse and alcoholism of social pressures, legal
requirements respecting the use of alcoholic
beverages, the cost of such beverages, and the
economic status and education of users of such
beverages,
(F) the interrelationship between alcohol
use and other health problems,
(G) the comparison of the cost and
effectiveness of various treatment methods for
alcoholism and alcohol abuse and the
effectiveness of prevention and intervention
programs for alcoholism and alcohol abuse, and
(H) alcoholism and alcohol abuse among
women;
(4) secure from time to time and for such periods
as he deems advisable, the assistance and advice of
experts, scholars, and consultants from the United
States or abroad;
(5) promote the coordination of research programs
conducted by the Institute, and similar programs
conducted by the National Institute of Drug Abuse and
by other departments, agencies, organizations, and
individuals, including all National Institutes of
Health research activities which are or may be related
to the problems of individuals suffering from
alcoholism or alcohol abuse or those of their families
or the impact of alcohol abuse on other health
problems;
(6) conduct an intramural program of biomedical,
behavioral, epidemiological, and social research,
including research into the most effective means of
treatment and service delivery, and including research
involving human subjects, which is--
(A) located in an institution capable of
providing all necessary medical care for such
human subjects, including complete 24-hour
medical diagnostic services by or under the
supervision of physicians, acute and intensive
medical care, including 24-hour emergency care,
psychiatric care, and such other care as is
determined to be necessary for individuals
suffering from alcoholism and alcohol abuse;
and
(B) associated with an accredited medical
or research training institution;
(7) for purposes of study, admit and treat at
institutions, hospitals, and stations of the Public
Health Service, persons not otherwise eligible for such
treatment;
(8) provide to health officials, scientists, and
appropriate public and other nonprofit institutions and
organizations, technical advice and assistance on the
application of statistical and other scientific
research methods to experiments, studies, and surveys
in health and medical fields;
(9) enter into contracts under this title without
regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529; \1\ 41 U.S.C. 5); and
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\1\ Now codified to section 3324 of title 31, United States Code.
---------------------------------------------------------------------------
(10) adopt, upon recommendation of the National
Advisory Council on Alcohol Abuse and Alcoholism, such
additional means as he deems necessary or appropriate
to carry out the purposes of this section.
(c) Collaboration.--The Director of the Institute shall
collaborate with the Administrator of the Substance Abuse and
Mental Health Services Administration in focusing the services
research activities of the Institute and in disseminating the
results of such research to health professionals and the
general public.
associate director for prevention
Sec. 464I. [285n-1] (a) In General.--There shall be in the
Institute an Associate Director for Prevention who shall be
responsible for the full-time coordination and promotion of the
programs in the Institute concerning the prevention of alcohol
abuse and alcoholism. The Associate Director shall be appointed
by the Director of the Institute from individuals who because
of their professional training or expertise are experts in
alcohol abuse and alcoholism or the prevention of such.
(b) Biennial Report.--The Associate Director for Prevention
shall prepare for inclusion in the biennial report made under
section 407 a description of the prevention activities of the
Institute, including a description of the staff and resources
allocated to those activities.
national alcohol research center
Sec. 464J. [285n-2] (a) The Secretary acting through the
Institute may designate National Alcohol Research Centers for
the purpose of interdisciplinary research relating to
alcoholism and other biomedical, behavioral, and social issues
related to alcoholism and alcohol abuse. No entity may be
designated as a Center unless an application therefor has been
submitted to, and approved by, the Secretary. Such an
application shall be submitted in such manner and contain such
information as the Secretary may reasonably require. The
Secretary may not approve such an application unless--
(1) the application contains or is supported by
reasonable assurances that--
(A) the applicant has the experience, or
capability, to conduct, through biomedical,
behavioral, social, and related disciplines,
long-term research on alcoholism and other
alcohol problems and to provide coordination of
such research among such disciplines;
(B) the applicant has available to it
sufficient facilities (including laboratory,
reference, and data analysis facilities) to
carry out the research plan contained in the
application,
(C) the applicant has facilities and
personnel to provide training in the prevention
and treatment of alcoholism and other alcohol
problems;
(D) the applicant has the capacity to train
predoctoral and postdoctoral students for
careers in research on alcoholism and other
alcohol problems;
(E) the applicant has the capacity to
conduct courses on alcohol problems and
research on alcohol problems for undergraduate
and graduate students, and medical and
osteopathic, nursing, social work, and other
specialized graduate students; and
(F) the applicant has the capacity to
conduct programs of continuing education in
such medical, legal, and social service fields
as the Secretary may require. \1\
---------------------------------------------------------------------------
\1\ So in law. See section 16(a)(5) of Public Law 96-180 (93 Stat.
1305). The period probably should be ``; and''. (Section 464J formerly
was section 504 of another law. The amendment made by Public Law 96-180
was directed to section 504 of that other law, which was Public Law 91-
616.)
---------------------------------------------------------------------------
(2) the application contains a detailed five-year
plan for research relating to alcoholism and other
alcohol problems.
(b) The Secretary shall, under such conditions as the
Secretary may reasonably require, make annual grants to Centers
which have been designated under this section. No funds
provided under a grant under this subsection may be used for
the purchase of any land or the purchase, construction,
preservation, or repair of any building. For the purposes of
the preceding sentence, the term ``construction'' has the
meaning given that term by section 701(1). \2\ The Secretary
shall include in the grants made under this section for fiscal
year beginning after September 30, 1981, a grant to a
designated Center for research on the effects of alcohol on the
elderly.
---------------------------------------------------------------------------
\2\ So in law. See section 2(a) of Public Law 102-352 (106 Stat.
938). Section 701(1) does not provide a definition for the term
``construction'', but former section 701(1) did provide such a
definition. Public Law 102-408 amended title VII generally; definitions
for the title are now provided in section 799, and that section does
not define the term ``construction''.
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Subpart 15--National Institute on Drug Abuse
purpose of institute
Sec. 464L. [285o] (a) In General.--The general purpose of
the National Institute on Drug Abuse (hereafter in this subpart
referred to as the ``Institute'') is the conduct and support of
biomedical and behavioral research, health services research,
research training, and health information dissemination with
respect to the prevention of drug abuse and the treatment of
drug abusers.
(b) Research Program.--The research program established
under this subpart shall encompass the social, behavioral, and
biomedical etiology, mental and physical health consequences,
and social and economic consequences of drug abuse. In carrying
out the program, the Director of the Institute shall give
special consideration to projects relating to drug abuse among
women (particularly with respect to pregnant women).
(c) Collaboration.--The Director of the Institute shall
collaborate with the Substance Abuse and Mental Health Services
Administration in focusing the services research activities of
the Institute and in disseminating the results of such research
to health professionals and the general public.
associate director for prevention
Sec. 464M. [285o-1] (a) In General.--There shall be in the
Institute an Associate Director for Prevention who shall be
responsible for the full-time coordination and promotion of the
programs in the Institute concerning the prevention of drug
abuse. The Associate Director shall be appointed by the
Director of the Institute from individuals who because of their
professional training or expertise are experts in drug abuse
and the prevention of such abuse.
(b) Report.--The Associate Director for Prevention shall
prepare for inclusion in the biennial report made under section
407 a description of the prevention activities of the
Institute, including a description of the staff and resources
allocated to those activities.
drug abuse research centers
Sec. 464N. [285o-2] (a) Authority.--The Director of the
Institute may designate National Drug Abuse Research Centers
for the purpose of interdisciplinary research relating to drug
abuse and other biomedical, behavioral, and social issues
related to drug abuse. No entity may be designated as a Center
unless an application therefore has been submitted to, and
approved by, the Secretary. Such an application shall be
submitted in such manner and contain such information as the
Secretary may reasonably require. The Secretary may not approve
such an application unless--
(1) the application contains or is supported by
reasonable assurances that--
(A) the applicant has the experience, or
capability, to conduct, through biomedical,
behavioral, social, and related disciplines,
long-term research on drug abuse and to provide
coordination of such research among such
disciplines;
(B) the applicant has available to it
sufficient facilities (including laboratory,
reference, and data analysis facilities) to
carry out the research plan contained in the
application;
(C) the applicant has facilities and
personnel to provide training in the prevention
and treatment of drug abuse;
(D) the applicant has the capacity to train
predoctoral and postdoctoral students for
careers in research on drug abuse;
(E) the applicant has the capacity to
conduct courses on drug abuse problems and
research on drug abuse for undergraduate and
graduate students, and medical and osteopathic,
nursing, social work, and other specialized
graduate students; and
(F) the applicant has the capacity to
conduct programs of continuing education in
such medical, legal, and social service fields
as the Secretary may require. \1\
---------------------------------------------------------------------------
\1\ So in law. See section 123(b) of Public Law 102-321 (106 Stat.
361). The period probably should be ``; and''.
---------------------------------------------------------------------------
(2) the application contains a detailed five-year
plan for research relating to drug abuse.
(b) Grants.--The Director of the Institute shall, under
such conditions as the Secretary may reasonably require, make
annual grants to Centers which have been designated under this
section. No funds provided under a grant under this subsection
may be used for the purchase of any land or the purchase,
construction, preservation, or repair of any building. For the
purposes of the preceding sentence, the term ``construction''
has the meaning given that term by section 701(1). \2\
---------------------------------------------------------------------------
\2\ See footnote for section 464J(b).
---------------------------------------------------------------------------
(c) Drug Abuse and Addition \3\ Research.--
---------------------------------------------------------------------------
\3\ Probably should be ``Addiction''. See section 2203 of Public
Law 107-273 (116 Stat. 1794).
---------------------------------------------------------------------------
(1) Grants or cooperative agreements.--The Director
of the Institute may make grants or enter into
cooperative agreements to expand the current and
ongoing interdisciplinary research and clinical trials
with treatment centers of the National Drug Abuse
Treatment Clinical Trials Network relating to drug
abuse and addiction, including related biomedical,
behavioral, and social issues.
(2) Use of funds.--Amounts made available under a
grant or cooperative agreement under paragraph (1) for
drug abuse and addiction may be used for research and
clinical trials relating to--
(A) the effects of drug abuse on the human
body, including the brain;
(B) the addictive nature of drugs and how
such effects differ with respect to different
individuals;
(C) the connection between drug abuse and
mental health;
(D) the identification and evaluation of
the most effective methods of prevention of
drug abuse and addiction;
(E) the identification and development of
the most effective methods of treatment of drug
addiction, including pharmacological
treatments;
(F) risk factors for drug abuse;
(G) effects of drug abuse and addiction on
pregnant women and their fetuses; and
(H) cultural, social, behavioral,
neurological, and psychological reasons that
individuals abuse drugs, or refrain from
abusing drugs.
(3) Research results.--The Director shall promptly
disseminate research results under this subsection to
Federal, State, and local entities involved in
combating drug abuse and addiction.
office on aids
Sec. 464O. [285o-3] The Director of the Institute shall
establish within the Institute an Office on AIDS. The Office
shall be responsible for the coordination of research and
determining the direction of the Institute with respect to AIDS
research related to--
(1) primary prevention of the spread of HIV,
including transmission via drug abuse;
(2) drug abuse services research; and
(3) other matters determined appropriate by the
Director.
medication development program
Sec. 464P. [285o-4] (a) Establishment.--There is
established in the Institute a Medication Development Program
through which the Director of such Institute shall--
(1) conduct periodic meetings with the Commissioner
of Food and Drugs to discuss measures that may
facilitate the approval process of drug abuse
treatments;
(2) encourage and promote (through grants,
contracts, international collaboration, or otherwise)
expanded research programs, investigations,
experiments, community trials, and studies, into the
development and use of medications to treat drug
addiction;
(3) establish or provide for the establishment of
research facilities;
(4) report on the activities of other relevant
agencies relating to the development and use of
pharmacotherapeutic treatments for drug addiction;
(5) collect, analyze, and disseminate data useful
in the development and use of pharmacotherapeutic
treatments for drug addiction and collect, catalog,
analyze, and disseminate through international
channels, the results of such research;
ctly or through grants, contracts, or cooperative
agreements, support training in the fundamental
sciences and clinical disciplines related to the
pharmacotherapeutic treatment of drug abuse, including
the use of training stipends, fellowships, and awards
where appropriate; and
(7) coordinate the activities conducted under this
section with related activities conducted within the
National Institute on Alcohol Abuse and Alcoholism, the
National Institute of Mental Health, and other
appropriate institutes and shall consult with the
Directors of such Institutes.
(b) Duties.--In carrying out the activities described in
subsection (a), the Director of the Institute--
(1) shall collect and disseminate through
publications and other appropriate means, information
pertaining to the research and other activities under
this section;
(2) shall make grants to or enter into contracts
and cooperative agreements with individuals and public
and private entities to further the goals of the
program;
(3) may, in accordance with section 496, and in
consultation with the National Advisory Council on Drug
Abuse, acquire, construct, improve, repair, operate,
and maintain pharmacotherapeutic research centers,
laboratories, and other necessary facilities and
equipment, and such other real or personal property as
the Director determines necessary, and may, in
consultation with such Advisory Council, make grants
for the construction or renovation of facilities to
carry out the purposes of this section;
(4) may accept voluntary and uncompensated
services;
(5) may accept gifts, or donations of services,
money, or property, real, personal, or mixed, tangible
or intangible; and
(6) shall take necessary action to ensure that all
channels for the dissemination and exchange of
scientific knowledge and information are maintained
between the Institute and the other scientific,
medical, and biomedical disciplines and organizations
nationally and internationally.
(c) Report.--
(1) In general.--Not later than December 31, 1992,
and each December 31 thereafter, the Director of the
Institute shall submit to the Office of National Drug
Control Policy established under section 1002 of the
Anti-Drug Abuse Act of 1988 (21 U.S.C. 1501) a report,
in accordance with paragraph (3), that describes the
objectives and activities of the program assisted under
this section.
(2) National drug control strategy.--The Director
of National Drug Control Policy shall incorporate, by
reference or otherwise, each report submitted under
this subsection in the National Drug Control Strategy
submitted the following February 1 under section 1005
of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
(d) Definition.--For purposes of this section, the term
``pharmacotherapeutics'' means medications used to treat the
symptoms and disease of drug abuse, including medications to--
(1) block the effects of abused drugs;
(2) reduce the craving for abused drugs;
(3) moderate or eliminate withdrawal symptoms;
(4) block or reverse the toxic effect of abused
drugs; or
(5) prevent relapse in persons who have been
detoxified from drugs of abuse.
Subpart 16--National Institute of Mental Health
purpose of institute
Sec. 464R. [285p] (a) In General.--The general purpose of
the National Institute of Mental Health (hereafter in this
subpart referred to as the ``Institute'') is the conduct and
support of biomedical and behavioral research, health services
research, research training, and health information
dissemination with respect to the cause, diagnosis, treatment,
control and prevention of mental illness.
(b) Research Program.--The research program established
under this subpart shall include support for biomedical and
behavioral neuroscience and shall be designed to further the
treatment and prevention of mental illness, the promotion of
mental health, and the study of the psychological, social and
legal factors that influence behavior.
(c) Collaboration.--The Director of the Institute shall
collaborate with the Administrator of the Substance Abuse and
Mental Health Services Administration in focusing the services
research activities of the Institute and in disseminating the
results of such research to health professionals and the
general public.
(d) Information With Respect to Suicide.--
(1) In general.--The Director of the Institute
shall--
(A) develop and publish information with
respect to the causes of suicide and the means
of preventing suicide; and
(B) make such information generally
available to the public and to health
professionals.
(2) Youth suicide.--Information described in
paragraph (1) shall especially relate to suicide among
individuals under 24 years of age.
(e) Associate Director for Special Populations.--
(1) In general.--The Director of the Institute
shall designate an Associate Director for Special
Populations.
(2) Duties.--The Associate Director for Special
Populations shall--
(A) develop and coordinate research
policies and programs to assure increased
emphasis on the mental health needs of women
and minority populations;
(B) support programs of basic and applied
social and behavioral research on the mental
health problems of women and minority
populations;
(C) study the effects of discrimination on
institutions and individuals, including
majority institutions and individuals;
(D) support and develop research designed
to eliminate institutional discrimination; and
(E) provide increased emphasis on the
concerns of women and minority populations in
training programs, service delivery programs,
and research endeavors of the Institute.
associate director for prevention
Sec. 464S. [285p-1] (a) In General.--There shall be in the
Institute an Associate Director for Prevention who shall be
responsible for the full-time coordination and promotion of the
programs in the Institute concerning the prevention of mental
disorder. The Associate Director shall be appointed by the
Director of the Institute from individuals who because of their
professional training or expertise are experts in mental
disorder and the prevention of such.
(b) Report.--The Associate Director for Prevention shall
prepare for inclusion in the biennial report made under section
407 a description of the prevention activities of the
Institute, including a description of the staff and resources
allocated to those activities.
office of rural mental health research
Sec. 464T. [285p-2] (a) In General.--There is established
within the Institute an office to be known as the Office of
Rural Mental Health Research (hereafter in this section
referred to as the ``Office''). The Office shall be headed by a
director, who shall be appointed by the Director of such
Institute from among individuals experienced or knowledgeable
in the provision of mental health services in rural areas. The
Secretary shall carry out the authorities established in this
section acting through the Director of the Office.
(b) Coordination of Activities.--The Director of the
Office, in consultation with the Director of the Institute and
with the Director of the Office of Rural Health Policy, shall--
(1) coordinate the research activities of the
Department of Health and Human Services as such
activities relate to the mental health of residents of
rural areas; and
(2) coordinate the activities of the Office with
similar activities of public and nonprofit private
entities.
(c) Research, Demonstrations, Evaluations, and
Dissemination.--The Director of the Office may, with respect to
the mental health of adults and children residing in rural
areas--
(1) conduct research on conditions that are unique
to the residents of rural areas, or more serious or
prevalent in such residents;
(2) conduct research on improving the delivery of
services in such areas; and
(3) disseminate information to appropriate public
and nonprofit private entities.
(d) Authority Regarding Grants and Contracts.--The Director
of the Office may carry out the authorities established in
subsection (c) directly and through grants, cooperative
agreements, or contracts with public or nonprofit private
entities.
office on aids
Sec. 464U. [285p-3] The Director of the Institute shall
establish within the Institute an Office on AIDS. The Office
shall be responsible for the coordination of research and
determining the direction of the Institute with respect to AIDS
research related to--
(1) primary prevention of the spread of HIV,
including transmission via sexual behavior;
(2) mental health services research; and
(3) other matters determined appropriate by the
Director.
Subpart 17--National Institute of Nursing Research
purpose of the institute
Sec. 464V. [285q] The general purpose of the National
Institute of Nursing Research (in this subpart referred to as
the ``Institute'') is the conduct and support of, and
dissemination of information respecting, basic and clinical
nursing research, training, and other programs in patient care
research.
specific authorities
Sec. 464W. [285q-1] To carry out section 464V, the Director
of the Institute may provide research training and instruction
and establish, in the Institute and other nonprofit
institutions, research traineeships and fellowships in the
study and investigation of the prevention of disease, health
promotion, and the nursing care of individuals with and the
families of individuals with acute and chronic illnesses. The
Director of the Institute may provide individuals receiving
such training and instruction or such traineeships or
fellowships with such stipends and allowances (including
amounts for travel and subsistence and dependency allowances)
as the Director determines necessary. The Director may make
grants to nonprofit institutions to provide such training and
instruction and traineeships and fellowships.
advisory council
Sec. 464X. [285q-2] (a)(1) The Secretary shall appoint an
advisory council for the Institute which shall advise, assist,
consult with, and make recommendations to the Secretary and the
Director of the Institute on matters related to the activities
carried out by and through the Institute and the policies
respecting such activities.
(2) The advisory council for the Institute may recommend to
the Secretary acceptance, in accordance with section 2701, \1\
of conditional gifts for study, investigations, and research
and for the acquisition of grounds or construction, equipping,
or maintenance of facilities for the Institute.
---------------------------------------------------------------------------
\1\ Probably should be section 231. That section formerly was
section 2701, and was redesignated by subsection (a)(2) of section 2010
of Public Law 103-43 (107 Stat. 213). Subsection (b)(5) of such section
purported to conform the above reference, but the amendment cannot be
executed because the amendment applied to the incorrect section. (The
conforming amendment applied to section 485. Section 464X formerly was
section 485, and was redesignated by section 1511(b)(2)(B) of Public
Law 103-43 (107 Stat. 179).)
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(3) The advisory council for the Institute--
(A)(i) may make recommendations to the Director of
the Institute respecting research conducted at the
Institute,
(ii) may review applications for grants and
cooperative agreements for research or training and
recommend for approval applications for projects which
show promise of making valuable contributions to human
knowledge, and
(iii) may review any grant, contract, or
cooperative agreement proposed to be made or entered
into by the Institute;
(B) may collect, by correspondence or by personal
investigation, information as to studies which are
being carried on in the United States or any other
country as to the diseases, disorders, or other aspects
of human health with respect to which the Institute is
concerned and with the approval of the Director of the
Institute make available such information through
appropriate publications for the benefit of public and
private health entities and health professions
personnel and scientists and for the information of the
general public; and
(C) may appoint subcommittees and convene workshops
and conferences.
(b)(1) The advisory council shall consist of ex officio
members and not more than eighteen members appointed by the
Secretary.
(2) The ex officio members of the advisory council shall
consist of--
(A) the Secretary, the Director of NIH, the
Director of the Institute, the chief nursing officer of
the Department of Veterans Affairs, the Assistant
Secretary of Defense for Health Affairs, the Director
of the Division of Nursing of the Health Resources and
Services Administration (or the designees of such
officers), and
(B) such additional officers or employees of the
United States as the Secretary determines necessary for
the advisory council to effectively carry out its
functions.
(3) The members of the advisory council who are not ex
officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by
the Secretary from among the leading representatives of
the health and scientific disciplines (including public
health and the behavioral or social sciences) relevant
to the activities of the Institute. Of the members
appointed pursuant to this subparagraph, at least seven
shall be professional nurses who are recognized experts
in the area of clinical practice, education, or
research.
(B) One-third of the members shall be appointed by
the Secretary from the general public and shall include
leaders in fields of public policy, law, health policy,
economics, and management.
(4) Members of the advisory council who are officers or
employees of the United States shall not receive any
compensation for service on the advisory council. The other
members of the advisory council shall receive, for each day
(including traveltime) they are engaged in the performance of
the functions of the advisory council, compensation at rates
not to exceed the daily equivalent of the annual rate in effect
for grade GS-18 of the General Schedule.
(c) The term of office of an appointed member of the
advisory council is four years, except that any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term and the Secretary
shall make appointments to an advisory council in such a manner
as to ensure that the terms of the members do not all expire in
the same year. A member may serve after the expiration of the
member's term until a successor has taken office. A member who
has been appointed for a term of four years may not be
reappointed to an advisory council before two years from the
date of expiration of such term of office. If a vacancy occurs
in the advisory council among the appointed members, the
Secretary shall make an appointment to fill the vacancy within
90 days from the date the vacancy occurs.
(d) The chairman of the advisory council shall be selected
by the Secretary from among the appointed members, except that
the Secretary may select the Director of the Institute to be
the chairman of the advisory council. The term of office of the
chairman shall be two years.
(e) The advisory council shall meet at the call of the
chairman or upon the request of the Director of the Institute,
but at least three times each fiscal year. The location of the
meetings of the advisory council is subject to the approval of
the Director of the Institute.
(f) The Director of the Institute shall designate a member
of the staff of the Institute to serve as the executive
secretary of the advisory council. The Director of the
Institute shall make available to the advisory council such
staff, information, and other assistance as it may require to
carry out its functions. The Director of the Institute shall
provide orientation and training for new members of the
advisory council to provide them with such information and
training as may be appropriate for their effective
participation in the functions of the advisory council.
(g) The advisory council may prepare, for inclusion in the
biennial report made under section 464Y, (1) comments
respecting the activities of the advisory council in the fiscal
years respecting which the report is prepared, (2) comments on
the progress of the Institute in meeting its objectives, and
(3) recommendations respecting the future directions and
program and policy emphasis of the Institute. The advisory
council may prepare such additional reports as it may determine
appropriate.
biennial report
Sec. 464Y. [285q-3] The Director of the Institute after
consultation with the advisory council for the Institute, shall
prepare for inclusion in the biennial report made under section
403 a biennial report which shall consist of a description of
the activities of the Institute and program policies of the
Director of the Institute in the fiscal years respecting which
the report is prepared. The Director of the Institute may
prepare such additional reports as the Director determines
appropriate. The Director of the Institute shall provide the
advisory council of the Institute an opportunity for the
submission of the written comments referred to in section
464X(g).
Subpart 18--National Institute of Biomedical Imaging and Bioengineering
purpose of the institute
Sec. 464z. [285r] (a) The general purpose of the National
Institute of Biomedical Imaging and Bioengineering (in this
section referred to as the ``Institute'') is the conduct and
support of research, training, the dissemination of health
information, and other programs with respect to biomedical
imaging, biomedical engineering, and associated technologies
and modalities with biomedical applications (in this section
referred to as ``biomedical imaging and bioengineering'').
(b)(1) The Director of the Institute, with the advice of
the Institute's advisory council, shall establish a National
Biomedical Imaging and Bioengineering Program (in this section
referred to as the ``Program'').
(2) Activities under the Program shall include the
following with respect to biomedical imaging and
bioengineering:
(A) Research into the development of new techniques
and devices.
(B) Related research in physics, engineering,
mathematics, computer science, and other disciplines.
(C) Technology assessments and outcomes studies to
evaluate the effectiveness of biologics, materials,
processes, devices, procedures, and informatics.
(D) Research in screening for diseases and
disorders.
(E) The advancement of existing imaging and
bioengineering modalities, including imaging,
biomaterials, and informatics.
(F) The development of target-specific agents to
enhance images and to identify and delineate disease.
(G) The development of advanced engineering and
imaging technologies and techniques for research from
the molecular and genetic to the whole organ and body
levels.
(H) The development of new techniques and devices
for more effective interventional procedures (such as
image-guided interventions).
(3)(A) With respect to the Program, the Director of the
Institute shall prepare and transmit to the Secretary and the
Director of NIH a plan to initiate, expand, intensify, and
coordinate activities of the Institute with respect to
biomedical imaging and bioengineering. The plan shall include
such comments and recommendations as the Director of the
Institute determines appropriate. The Director of the Institute
shall periodically review and revise the plan and shall
transmit any revisions of the plan to the Secretary and the
Director of NIH.
(B) The plan under subparagraph (A) shall include the
recommendations of the Director of the Institute with respect
to the following:
(i) Where appropriate, the consolidation of
programs of the National Institutes of Health for the
express purpose of enhancing support of activities
regarding basic biomedical imaging and bioengineering
research.
(ii) The coordination of the activities of the
Institute with related activities of the other agencies
of the National Institutes of Health and with related
activities of other Federal agencies.
(c) The establishment under section 406 of an advisory
council for the Institute is subject to the following:
(1) The number of members appointed by the
Secretary shall be 12.
(2) Of such members--
(A) six members shall be scientists,
engineers, physicians, and other health
professionals who represent disciplines in
biomedical imaging and bioengineering and who
are not officers or employees of the United
States; and
(B) six members shall be scientists,
engineers, physicians, and other health
professionals who represent other disciplines
and are knowledgeable about the applications of
biomedical imaging and bioengineering in
medicine, and who are not officers or employees
of the United States.
(3) In addition to the ex officio members specified
in section 406(b)(2), the ex officio members of the
advisory council shall include the Director of the
Centers for Disease Control and Prevention, the
Director of the National Science Foundation, and the
Director of the National Institute of Standards and
Technology (or the designees of such officers).
H2 deg.Subpart 19--National Human Genome Research Institute
purpose of the center \1\
---------------------------------------------------------------------------
\1\ The word ``center'' in the section heading probably should read
``institute''. Section 101(c)(4)(C) of Public Law 109-482 (120 Stat.
3675) struck ``center'' each place such term appeared in this subpart
and inserted ``institute''. However, this amendment was not effective
with respect to the section heading because the word ``center'' appears
in small caps.
---------------------------------------------------------------------------
Sec. 464z-1. [285s] (a) The general purpose of the National
Human Genome Research Institute (in this subpart referred to as
the ``Institute'') is to characterize the structure and
function of the human genome, including the mapping and
sequencing of individual genes. Such purpose includes--
(1) planning and coordinating the research goal of
the genome project;
(2) reviewing and funding research proposals;
(3) developing training programs;
(4) coordinating international genome research;
(5) communicating advances in genome science to the
public; and
(6) reviewing and funding proposals to address the
ethical and legal issues associated with the genome
project (including legal issues regarding patents).
(b) The Director of the Institute may conduct and support
research training--
(1) for which fellowship support is not provided
under section 487; and
(2) that is not residency training of physicians or
other health professionals.
(c)(1) Except as provided in paragraph (2), of the amounts
appropriated to carry out subsection (a) for a fiscal year, the
Director of the Institute shall make available not less than 5
percent for carrying out paragraph (6) of such subsection.
(2) With respect to providing funds under subsection (a)(6)
for proposals to address the ethical issues associated with the
genome project, paragraph (1) shall not apply for a fiscal year
if the Director of the Institute certifies to the Committee on
Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, that the
Director has determined that an insufficient number of such
proposals meet the applicable requirements of sections 491 and
492.
Subpart 20--National Institute on Minority Health and Health
Disparities
SEC. 464Z-3. [285T] PURPOSE OF CENTER \1\.
---------------------------------------------------------------------------
\1\ The word ``CENTER'' in the section heading for section 464z-3
probably should read ``INSTITUTE''. See amendment made by section
10334(c)(1)(D)(iii) of Public Law 111-148.
---------------------------------------------------------------------------
(a) In General.--The general purpose of the National
Institute on Minority Health and Health Disparities (in this
subpart referred to as the ``Institute'') is the conduct and
support of research, training, dissemination of information,
and other programs with respect to minority health conditions
and other populations with health disparities.
(b) Priorities.--The Director of the Institute shall in
expending amounts appropriated under this subpart give priority
to conducting and supporting minority health disparities
research.
(c) Minority Health Disparities Research.--For purposes of
this subpart:
(1) The term ``minority health disparities
research'' means basic, clinical, and behavioral
research on minority health conditions (as defined in
paragraph (2)), including research to prevent,
diagnose, and treat such conditions.
(2) The term ``minority health conditions'', with
respect to individuals who are members of minority
groups, means all diseases, disorders, and conditions
(including with respect to mental health and substance
abuse)--
(A) unique to, more serious, or more
prevalent in such individuals;
(B) for which the factors of medical risk
or types of medical intervention may be
different for such individuals, or for which it
is unknown whether such factors or types are
different for such individuals; or
(C) with respect to which there has been
insufficient research involving such
individuals as subjects or insufficient data on
such individuals.
(3) The term ``minority group'' has the meaning
given the term ``racial and ethnic minority group'' in
section 1707.
(4) The terms ``minority'' and ``minorities'' refer
to individuals from a minority group.
(d) Health Disparity Populations.--For purposes of this
subpart:
(1) A population is a health disparity population
if, as determined by the Director of the Institute
after consultation with the Director of the Agency for
Healthcare Research and Quality, there is a significant
disparity in the overall rate of disease incidence,
prevalence, morbidity, mortality, or survival rates in
the population as compared to the health status of the
general population.
(2) The Director shall give priority consideration
to determining whether minority groups qualify as
health disparity populations under paragraph (1).
(3) The term ``health disparities research'' means
basic, clinical, and behavioral research on health
disparity populations (including individual members and
communities of such populations) that relates to health
disparities as defined under paragraph (1), including
the causes of such disparities and methods to prevent,
diagnose, and treat such disparities.
(e) Coordination of Activities.--The Director of the
Institute shall act as the primary Federal official with
responsibility for coordinating all minority health disparities
research and other health disparities research conducted or
supported by the National Institutes of Health, and--
(1) shall represent the health disparities research
program of the National Institutes of Health, including
the minority health disparities research program, at
all relevant Executive branch task forces, committees
and planning activities; and
(2) shall maintain communications with all relevant
Public Health Service agencies, including the Indian
Health Service, and various other departments of the
Federal Government to ensure the timely transmission of
information concerning advances in minority health
disparities research and other health disparities
research between these various agencies for
dissemination to affected communities and health care
providers.
(f) Collaborative Comprehensive Plan and Budget.--
(1) In general.--Subject to the provisions of this
section and other applicable law, the Director of NIH,
the Director of the Institute, and the directors of the
other agencies of the National Institutes of Health in
collaboration (and in consultation with the advisory
council for the Institute) shall--
(A) establish a comprehensive plan and
budget for the conduct and support of all
minority health disparities research and other
health disparities research activities of the
agencies of the National Institutes of Health
(which plan and budget shall be first
established under this subsection not later
than 12 months after the date of the enactment
of this subpart);
(B) ensure that the plan and budget
establish priorities among the health
disparities research activities that such
agencies are authorized to carry out;
(C) ensure that the plan and budget
establish objectives regarding such activities,
describes the means for achieving the
objectives, and designates the date by which
the objectives are expected to be achieved;
(D) ensure that, with respect to amounts
appropriated for activities of the Institute,
the plan and budget give priority in the
expenditure of funds to conducting and
supporting minority health disparities
research;
(E) ensure that all amounts appropriated
for such activities are expended in accordance
with the plan and budget;
(F) review the plan and budget not less
than annually, and revise the plan and budget
as appropriate;
(G) ensure that the plan and budget serve
as a broad, binding statement of policies
regarding minority health disparities research
and other health disparities research
activities of the agencies, but do not remove
the responsibility of the heads of the agencies
for the approval of specific programs or
projects, or for other details of the daily
administration of such activities, in
accordance with the plan and budget; and
(H) promote coordination and collaboration
among the agencies conducting or supporting
minority health or other health disparities
research.
(2) Certain components of plan and budget.--With
respect to health disparities research activities of
the agencies of the National Institutes of Health, the
Director of the Institute shall ensure that the plan
and budget under paragraph (1) provide for--
(A) basic research and applied research,
including research and development with respect
to products;
(B) research that is conducted by the
agencies;
(C) research that is supported by the
agencies;
(D) proposals developed pursuant to
solicitations by the agencies and for proposals
developed independently of such solicitations;
and
(E) behavioral research and social sciences
research, which may include cultural and
linguistic research in each of the agencies.
(3) Minority health disparities research.--The plan
and budget under paragraph (1) shall include a separate
statement of the plan and budget for minority health
disparities research.
(g) Participation in Clinical Research.--The Director of
the Institute shall work with the Director of NIH and the
directors of the agencies of the National Institutes of Health
to carry out the provisions of section 492B that relate to
minority groups.
(h) Research Endowments.--
(1) In general.--The Director of the Institute may
carry out a program to facilitate minority health
disparities research and other health disparities
research by providing for research endowments--
(1) at centers of excellence under section 736; and
(2) at centers of excellence under section 464z-4.
\1\
---------------------------------------------------------------------------
\1\ So in law. Section 10334(c)(2)(A) of Public Law 111-148 amends
(h)(1) by striking and inserting text that results in two paragraphs
(1) and (2). The second paragraph (1) and the first paragraph (2)
proabbly should be redesignated as subparagraphs (A) and (B),
respectively (and moving margins to the right so that they align with
subparagraphs cpmtaomed in paragraph (2)).
---------------------------------------------------------------------------
(2) Eligibility.--The Director of the Institute may
provide for a research endowment under paragraph (1)
only if the institution involved meets the following
conditions:
(A) The institution does not have an
endowment that is worth in excess of an amount
equal to 50 percent of the national median of
endowment funds at institutions that conduct
similar biomedical research or training of
health professionals.
(B) The application of the institution
under paragraph (1) regarding a research
endowment has been recommended pursuant to
technical and scientific peer review and has
been approved by the advisory council under
subsection (j).
(i) Certain Activities.--In carrying out subsection (a),
the Director of the Institute--
(1) shall assist the Director of the National
Institute for Research Resources in carrying out
section 481(c)(3) and in committing resources for
construction at Institutions of Emerging Excellence;
(2) shall establish projects to promote cooperation
among Federal agencies, State, local, tribal, and
regional public health agencies, and private entities
in health disparities research; and
(3) may utilize information from previous health
initiatives concerning minorities and other health
disparity populations.
(j) Advisory Council.--
(1) In general.--The Secretary shall, in accordance
with section 406, establish an advisory council to
advise, assist, consult with, and make recommendations
to the Director of the Institute on matters relating to
the activities described in subsection (a), and with
respect to such activities to carry out any other
functions described in section 406 for advisory
councils under such section. Functions under the
preceding sentence shall include making recommendations
on budgetary allocations made in the plan under
subsection (f), and shall include reviewing reports
under subsection (k) before the reports are submitted
under such subsection.
(2) Membership.--With respect to the membership of
the advisory council under paragraph (1), a majority of
the members shall be individuals with demonstrated
expertise regarding minority health disparity and other
health disparity issues; representatives of communities
impacted by minority and other health disparities shall
be included; and a diversity of health professionals
shall be represented. The membership shall in addition
include a representative of the Office of Behavioral
and Social Sciences Research under section 404A.
(h) \1\ Interagency Coordination.--The Director of the
Institute, as the primary Federal officials with responsibility
for coordinating all research and activities conducted or
supported by the National Institutes of Health on minority
health and health disparities, shall plan, coordinate, review
and evaluate research and other activities conducted or
supported by the Institutes and Centers of the National
Institutes of Health.
---------------------------------------------------------------------------
\1\ So in law. Section 10334(c)(2)(C) of Public Law 111-148 amends
section 464z-3 (as redesignated) by adding a subsection (h) at the end.
Probably should be a subsection (k).
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SEC. 464Z-4. [285T-1] CENTERS OF EXCELLENCE FOR RESEARCH EDUCATION AND
TRAINING.
(a) In General.--The Director of the Institute shall make
awards of grants or contracts to designated biomedical and
behavioral research institutions under paragraph (1) of
subsection (c), or to consortia under paragraph (2) of such
subsection, for the purpose of assisting the institutions in
supporting programs of excellence in biomedical and behavioral
research training for individuals who are members of minority
health disparity populations or other health disparity
populations.
(b) Required Use of Funds.--An award may be made under
subsection (a) only if the applicant involved agrees that the
grant will be expended--
(1) to train members of minority health disparity
populations or other health disparity populations as
professionals in the area of biomedical or behavioral
research or both; or
(2) to expand, remodel, renovate, or alter existing
research facilities or construct new research
facilities for the purpose of conducting minority
health disparities research and other health
disparities research.
(c) Centers of Excellence.--
(1) In general.--For purposes of this section, a
designated biomedical and behavioral research
institution is a biomedical and behavioral research
institution that--
(A) has a significant number of members of
minority health disparity populations or other
health disparity populations enrolled as
students in the institution (including
individuals accepted for enrollment in the
institution);
(B) has been effective in assisting such
students of the institution to complete the
program of education or training and receive
the degree involved;
(C) has made significant efforts to recruit
minority students to enroll in and graduate
from the institution, which may include
providing means-tested scholarships and other
financial assistance as appropriate; and
(D) has made significant recruitment
efforts to increase the number of minority or
other members of health disparity populations
serving in faculty or administrative positions
at the institution.
(2) Consortium.--Any designated biomedical and
behavioral research institution involved may, with
other biomedical and behavioral institutions
(designated or otherwise), including tribal health
programs, form a consortium to receive an award under
subsection (a).
(3) Application of criteria to other programs.--In
the case of any criteria established by the Director of
the Institute for purposes of determining whether
institutions meet the conditions described in paragraph
(1), this section may not, with respect to minority
health disparity populations or other health disparity
populations, be construed to authorize, require, or
prohibit the use of such criteria in any program other
than the program established in this section.
(d) Duration of Grant.--The period during which payments
are made under a grant under subsection (a) may not exceed 5
years. Such payments shall be subject to annual approval by the
Director of the Institute and to the availability of
appropriations for the fiscal year involved to make the
payments.
(e) Maintenance of Effort.--
(1) In general.--With respect to activities for
which an award under subsection (a) is authorized to be
expended, the Director of the Institute may not make
such an award to a designated research institution or
consortium for any fiscal year unless the institution,
or institutions in the consortium, as the case may be,
agree to maintain expenditures of non-Federal amounts
for such activities at a level that is not less than
the level of such expenditures maintained by the
institutions involved for the fiscal year preceding the
fiscal year for which such institutions receive such an
award.
(2) Use of federal funds.--With respect to any
Federal amounts received by a designated research
institution or consortium and available for carrying
out activities for which an award under subsection (a)
is authorized to be expended, the Director of the
Institute may make such an award only if the
institutions involved agree that the institutions will,
before expending the award, expend the Federal amounts
obtained from sources other than the award.
(f) Certain Expenditures.--The Director of the Institute
may authorize a designated biomedical and behavioral research
institution to expend a portion of an award under subsection
(a) for research endowments.
(g) Definitions.--For purposes of this section:
(1) The term ``designated biomedical and behavioral
research institution'' has the meaning indicated for
such term in subsection (c)(1). Such term includes any
health professions school receiving an award of a grant
or contract under section 736.
(2) The term ``program of excellence'' means any
program carried out by a designated biomedical and
behavioral research institution with an award under
subsection (a), if the program is for purposes for
which the institution involved is authorized in
subsection (b) to expend the grant.
SEC. 464Z-5. [285T-2] LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH
DISPARITIES RESEARCH.
(a) In General.--The Director of the Institute shall
establish a program of entering into contracts with qualified
health professionals under which such health professionals
agree to engage in minority health disparities research or
other health disparities research in consideration of the
Federal Government agreeing to repay, for each year of engaging
in such research, not more than $35,000 of the principal and
interest of the educational loans of such health professionals.
(b) Service Provisions.--The provisions of sections 338B,
338C, and 338E shall, except as inconsistent with subsection
(a), apply to the program established in such subsection to the
same extent and in the same manner as such provisions apply to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III.
(c) Requirement Regarding Health Disparity Populations.--
The Director of the Institute shall ensure that not fewer than
50 percent of the contracts entered into under subsection (a)
are for appropriately qualified health professionals who are
members of a health disparity population.
(d) Priority.--With respect to minority health disparities
research and other health disparities research under subsection
(a), the Secretary shall ensure that priority is given to
conducting projects of biomedical research.
SEC. 464Z-6. [285T-3] GENERAL PROVISIONS REGARDING THE CENTER.
The Secretary, acting through the Director of the National
Institutes of Health, shall provide administrative support and
support services to the Director of the Institute and shall
ensure that such support takes maximum advantage of existing
administrative structures at the agencies of the National
Institutes of Health.
Part D--National Library of Medicine
Subpart 1--General Provisions
purpose, establishment, and functions of the national library of
medicine
Sec. 465. [286] (a) In order to assist the advancement of
medical and related sciences and to aid the dissemination and
exchange of scientific and other information important to the
progress of medicine and to the public health, there is
established the National Library of Medicine (hereafter in this
part referred to as the ``Library'').
(b) The Secretary, through the Library and subject to
subsection (d), shall--
(1) acquire and preserve books, periodicals,
prints, films, recordings, and other library materials
pertinent to medicine;
(2) organize the materials specified in paragraph
(1) by appropriate cataloging, indexing, and
bibliographical listings;
(3) publish and disseminate the catalogs, indexes,
and bibliographies referred to in paragraph (2);
(4) make available, through loans, photographic or
other copying procedures, or otherwise, such materials
in the Library as the Secretary determines appropriate;
(5) provide reference and research assistance;
(6) publicize the availability from the Library of
the products and services described in any of
paragraphs (1) through (5);
(7) promote the use of computers and
telecommunications by health professionals (including
health professionals in rural areas) for the purpose of
improving access to biomedical information for health
care delivery and medical research; and
(8) engage in such other activities as the
Secretary determines appropriate and as the Library's
resources permit.
(c) The Secretary may exchange, destroy, or otherwise
dispose of any books, periodicals, films, and other library
materials not needed for the permanent use of the Library.
(d)(1) The Secretary may, after obtaining the advice and
recommendations of the Board of Regents, prescribe rules under
which the Library will--
(A) provide copies of its publications or
materials,
(B) will make available its facilities for
research, or
(C) will make available its bibliographic,
reference, or other services,
to public and private entities and individuals.
(2) Rules prescribed under paragraph (1) may provide for
making available such publications, materials, facilities, or
services--
(A) without charge as a public service,
(B) upon a loan, exchange, or charge basis, or
(C) in appropriate circumstances, under contract
arrangements made with a public or other nonprofit
entity.
(e) Whenever the Secretary, with the advice of the Board of
Regents, determines that--
(1) in any geographic area of the United States
there is no regional medical library adequate to serve
such area;
(2) under criteria prescribed for the
administration of section 475, there is a need for a
regional medical library to serve such area; and
(3) because there is no medical library located in
such area which, with financial assistance under
section 475, can feasibly be developed into a regional
medical library adequate to serve such area,
the Secretary may establish, as a branch of the Library, a
regional medical library to serve the needs of such area.
(f) Section 231 shall be applicable to the acceptance and
administration of gifts made for the benefit of the Library or
for carrying out any of its functions, and the Board of Regents
shall make recommendations to the Secretary relating to
establishment within the Library of suitable memorials to the
donors.
(g) For purposes of this part, the terms ``medicine'' and
``medical'', except when used in section 466, include
preventive and therapeutic medicine, dentistry, pharmacy,
hospitalization, nursing, public health, and the fundamental
sciences related thereto, and other related fields of study,
research, or activity.
board of regents
Sec. 466. [286a] (a)(1)(A) The Board of Regents of the
National Library of Medicine consists of ex officio members and
ten members appointed by the Secretary.
(B) The ex officio members are the Surgeons General of the
Public Health Service, the Army, the Navy, and the Air Force,
the Chief Medical Director of the Department of Veterans
Affairs, the Dean of the Uniformed Services University of the
Health Sciences, the Assistant Director for Biological,
Behavioral, and Social Sciences of the National Science
Foundation, the Director of the National Agricultural Library,
and the Librarian of Congress (or their designees).
(C) The appointed members shall be selected from among
leaders in the various fields of the fundamental sciences,
medicine, dentistry, public health, hospital administration,
pharmacology, health communications technology, or scientific
or medical library work, or in public affairs. At least six of
the appointed members shall be selected from among leaders in
the fields of medical, dental, or public health research or
education.
(2) The Board shall annually elect one of the appointed
members to serve as chairman until the next election. The
Secretary shall designate a member of the Library staff to act
as executive secretary of the Board.
(b) The Board shall advise, consult with, and make
recommendations to the Secretary on matters of policy in regard
to the Library, including such matters as the acquisition of
materials for the Library, the scope, content, and organization
of the Library's services, and the rules under which its
materials, publications, facilities, and services shall be made
available to various kinds of users. The Secretary shall
include in the annual report of the Secretary to the Congress a
statement covering the recommendations made by the Board and
the disposition thereof. The Secretary may use the services of
any member of the Board in connection with matters related to
the work of the Library, for such periods, in addition to
conference periods, as the Secretary may determine.
(c) Each appointed member of the Board shall hold office
for a term of four years, except that any member appointed to
fill a vacancy occurring prior to the expiration of the term
for which the predecessor of such member was appointed shall be
appointed for the remainder of such term. None of the appointed
members shall be eligible for reappointment within one year
after the end of the preceding term of such member.
library facilities
Sec. 467. [286a-1] The Administrator of General Services
may acquire, by purchase, condemnation, donation, or otherwise,
a suitable site or sites, selected by the Secretary in
accordance with the direction of the Board, for suitable and
adequate buildings and facilities for use of the Library and to
erect thereon, furnish, and equip such buildings and
facilities. Amounts appropriated to carry out this section may
be used for the cost of preparation of drawings and
specifications, supervision of construction, and other
administrative expenses incident to the work. The Administrator
of General Services shall prepare the plans and specifications,
make all necessary contracts, and supervise construction.
Subpart 2--Financial Assistance
definitions
Sec. 470. [286b-1] As used in this subpart--
(1) the term ``medical library'' means a library
related to the sciences related to health; and
(2) the term ``sciences related to health''
includes medicine, osteopathy, dentistry, and public
health, and fundamental and applied sciences when
related thereto.
national medical libraries assistance advisory board
Sec. 471. [286b-2] (a) The Board of Regents of the National
Library of Medicine shall also serve as the National Medical
Libraries Assistance Advisory Board (hereafter in this subpart
referred to as the ``Board'').
(b) The Board shall advise and assist the Secretary in the
preparation of general regulations and with respect to policy
matters arising in the administration of this subpart.
(c) The Secretary may use the services of any member of the
Board, in connection with matters related to the administration
of this part for such periods, in addition to conference
periods, as the Secretary may determine.
(d) Appointed members of the Board who are not otherwise in
the employ of the United States, while attending conferences of
the Board or otherwise serving at the request of the Secretary
in connection with the administration of this subpart, shall be
entitled to receive compensation, per diem in lieu of
subsistence, and travel expenses in the same manner and under
the same conditions as that prescribed under section 208(c)
when attending conferences, traveling, or serving at the
request of the Secretary in connection with the Board's
function under this section.
grants for training in medical library sciences
Sec. 472. [286b-3] The Secretary shall make grants--
(1) to individuals to enable them to accept
traineeships and fellowships leading to
postbaccalaureate academic degrees in the field of
medical library science, in related fields pertaining
to sciences related to health, or in the field of the
communication of information;
(2) to individuals who are librarians or
specialists in information on sciences relating to
health, to enable them to undergo intensive training or
retraining so as to attain greater competence in their
occupations (including competence in the fields of
automatic data processing and retrieval);
(3) to assist appropriate public and private
nonprofit institutions in developing, expanding, and
improving training programs in library science and the
field of communications of information pertaining to
sciences relating to health; and
(4) to assist in the establishment of internship
programs in established medical libraries meeting
standards which the Secretary shall prescribe.
assistance for special scientific projects, and for research and
development in medical library science and related fields
Sec. 473. [286b-4] (a) The Secretary shall make grants to
physicians and other practitioners in the sciences related to
health, to scientists, and to public or nonprofit private
institutions on behalf of such physicians, other practitioners,
and scientists for the compilation of existing, or the writing
of original, contributions relating to scientific, social, or
cultural advancements in sciences related to health. In making
such grants, the Secretary shall make appropriate arrangements
under which the facilities of the Library and the facilities of
libraries of public and private nonprofit institutions of
higher learning may be made available in connection with the
projects for which such grants are made.
(b) The Secretary shall make grants to appropriate public
or private nonprofit institutions and enter into contracts with
appropriate persons, for purposes of carrying out projects of
research, investigations, and demonstrations in the field of
medical library science and related activities and for the
development of new techniques, systems, and equipment, for
processing, storing, retrieving, and distributing information
pertaining to sciences related to health.
(c)(1) The Secretary shall make grants to public or
nonprofit private institutions for the purpose of carrying out
projects of research on, and development and demonstration of,
new education technologies.
(2) The purposes for which a grant under paragraph (1) may
be made include projects concerning--
(A) computer-assisted teaching and testing of
clinical competence at health professions and research
institutions;
(B) the effective transfer of new information from
research laboratories to appropriate clinical
applications;
(C) the expansion of the laboratory and clinical
uses of computer-stored research databases; and
(D) the testing of new technologies for training
health care professionals.
(3) The Secretary may not make a grant under paragraph (1)
unless the applicant for the grant agrees to make the projects
available with respect to--
(A) assisting in the training of health professions
students; and
(B) enhancing and improving the capabilities of
health professionals regarding research and teaching.
grants for establishing, expanding, and improving the basic resources
of medical libraries and related instrumentalities
Sec. 474. [286b-5] (a) The Secretary shall make grants of
money, materials, or both, to public or private nonprofit
medical libraries and related scientific communication
instrumentalities for the purpose of establishing, expanding,
and improving their basic medical library or related resources.
A grant under this subsection may be used for--
(1) the acquisition of books, journals,
photographs, motion picture and other films, and other
similar materials;
(2) cataloging, binding, and other services and
procedures for processing library resource materials
for use by those who are served by the library or
related instrumentality;
(3) the acquisition of duplication devices,
facsimile equipment, film projectors, recording
equipment, and other equipment to facilitate the use of
the resources of the library or related instrumentality
by those who are served by it; and
(4) the introduction of new technologies in medical
librarianship.
(b)(1) The amount of any grant under this section to any
medical library or related instrumentality shall be determined
by the Secretary on the basis of the scope of library or
related services provided by such library or instrumentality in
relation to the population and purposes served by it. In making
a determination of the scope of services served by any medical
library or related instrumentality, the Secretary shall take
into account--
(A) the number of graduate and undergraduate
students making use of the resources of such library or
instrumentality;
(B) the number of physicians and other
practitioners in the sciences related to health
utilizing the resources of such library or
instrumentality;
(C) the type of supportive staffs, if any,
available to such library or instrumentality;
(D) the type, size, and qualifications of the
faculty of any school with which such library or
instrumentality is affiliated;
(E) the staff of any hospital or hospitals or of
any clinic or clinics with which such library or
instrumentality is affiliated; and
(F) the geographic area served by such library or
instrumentality and the availability within such area
of medical library or related services provided by
other libraries or related instrumentalities.
(2) Grants to such medical libraries or related
instrumentalities under this section shall be in such amounts
as the Secretary may by regulation prescribe with a view to
assuring adequate continuing financial support for such
libraries or instrumentalities from other sources during and
after the period for which grants are provided, except that in
no case shall any grant under this section to a medical library
or related instrumentality for any fiscal year exceed
$1,000,000.
grants and contracts for establishment of regional medical libraries
Sec. 475. [286b-6] (a) The Secretary, with the advice of
the Board, shall make grants to and enter into contracts with
existing public or private nonprofit medical libraries so as to
enable each of them to serve as the regional medical library
for the geographical area in which it is located.
(b) The uses for which grants and contracts under this
section may be employed include the--
(1) acquisition of books, journals, and other
similar materials;
(2) cataloging, binding, and other procedures for
processing library resource materials for use by those
who are served by the library;
(3) acquisition of duplicating devices and other
equipment to facilitate the use of the resources of the
library by those who are served by it;
(4) acquisition of mechanisms and employment of
personnel for the speedy transmission of materials from
the regional library to local libraries in the
geographic area served by the regional library; and
(5) planning for services and activities under this
section.
(c)(1) Grants and contracts under this section shall only
be made to or entered into with medical libraries which agree--
(A) to modify and increase their library resources,
and to supplement the resources of cooperating
libraries in the region, so as to be able to provide
adequate supportive services to all libraries in the
region as well as to individual users of library
services; and
(B) to provide free loan services to qualified
users and make available photoduplicated or facsimile
copies of biomedical materials which qualified
requesters may retain.
(2) The Secretary, in awarding grants and contracts under
this section, shall give priority to medical libraries having
the greatest potential of fulfilling the needs for regional
medical libraries. In determining the priority to be assigned
to any medical library, the Secretary shall consider--
(A) the adequacy of the library (in terms of
collections, personnel, equipment, and other
facilities) as a basis for a regional medical library;
and
(B) the size and nature of the population to be
served in the region in which the library is located.
(d) Grants and contracts under this section for basic
resource materials to a library may not exceed--
(1) 50 percent of the library's annual operating
expense (exclusive of Federal financial assistance
under this part) for the preceding year; or
(2) in case of the first year in which the library
receives a grant under this section for basic resource
materials, 50 percent of its average annual operating
expenses over the past three years (or if it had been
in operation for less than three years, its annual
operating expenses determined by the Secretary in
accordance with regulations).
financial support of biomedical scientific publications
Sec. 476. [286b-7] (a) The Secretary, with the advice of
the Board, shall make grants to, and enter into appropriate
contracts with, public or private nonprofit institutions of
higher education and individual scientists for the purpose of
supporting biomedical scientific publications of a nonprofit
nature and to procure the compilation, writing, editing, and
publication of reviews, abstracts, indices, handbooks,
bibliographies, and related matter pertaining to scientific
works and scientific developments.
(b) Grants under subsection (a) in support of any single
periodical publication may not be made for more than three
years, except in those cases in which the Secretary determines
that further support is necessary to carry out the purposes of
subsection (a).
grant payments, records, and audit
Sec. 477. [286b-8] (a) Payments under grants made under
sections 472, 473, 474, 475, and 476 may be made in advance or
by way of reimbursement and in such installments as the
Secretary shall prescribe by regulation after consultation with
the Board.
(b)(1) Each recipient of a grant under this subpart shall
keep such records as the Secretary shall prescribe, including
records which fully disclose the amount and disposition by such
recipient of the proceeds of such grant, the total cost of the
project or undertaking in connection with which such grant is
given or used, and the amount of that portion of the cost of
the project or undertaking supplied by other sources, and such
other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall
have access for the purpose of audit and examination to any
books, documents, papers, and records of such recipients that
are pertinent to any grant received under this subpart.
H5 deg.Subpart 3--National Center for Biotechnology
Information
h3 deg.purpose, establishment, functions, and funding of the
national center for biotechnology information
Sec. 478. [286c] (a) In order to focus and expand the
collection, storage, retrieval, and dissemination of the
results of biotechnology research by information systems, and
to support and enhance the development of new information
technologies to aid in the understanding of the molecular
processes that control health and disease, there is established
the National Center for Biotechnology Information (hereinafter
in this section referred to as the ``Center'') in the National
Library of Medicine.
(b) The Secretary, through the Center and subject to
section 465(d), shall--
(1) design, develop, implement, and manage
automated systems for the collection, storage,
retrieval, analysis, and dissemination of knowledge
concerning human molecular biology, biochemistry, and
genetics;
(2) perform research into advanced methods of
computer-based information processing capable of
representing and analyzing the vast number of
biologically important molecules and compounds;
(3) enable persons engaged in biotechnology
research and medical care to use systems developed
under paragraph (1) and methods described in paragraph
(2); and
(4) coordinate, as much as is practicable, efforts
to gather biotechnology information on an international
basis.
H2 deg.Subpart 4--National Information Center on Health
Services Research and Health Care Technology
h3 deg.national information center
Sec. 478A. [286d] (a) There is established within the
Library an entity to be known as the National Information
Center on Health Services Research and Health Care Technology
(in this section referred to as the ``Center'').
(b) The purpose of the Center is the collection, storage,
analysis, retrieval, and dissemination of information on health
services research, clinical practice guidelines, and on health
care technology, including the assessment of such technology.
Such purpose includes developing and maintaining data bases and
developing and implementing methods of carrying out such
purpose.
(c) The Director of the Center shall ensure that
information under subsection (b) concerning clinical practice
guidelines is collected and maintained electronically and in a
convenient format. Such Director shall develop and publish
criteria for the inclusion of practice guidelines and
technology assessments in the information center database.
(d) The Secretary, acting through the Center, shall
coordinate the activities carried out under this section
through the Center with related activities of the Administrator
for Health Care Policy and Research.
Part E--Other Agencies of NIH
Subpart 1--National Center for Research Resources
general purpose
Sec. 479. [287] The general purpose of the National Center
for Research Resources (in this subpart referred to as the
``Center'') is to strengthen and enhance the research
environments of entities engaged in health-related research by
developing and supporting essential research resources.
advisory council
Sec. 480. [287a] (a)(1) The Secretary shall appoint an
advisory council for the Center which shall advise, assist,
consult with, and make recommendations to the Secretary and the
Director of the Center on matters related to the activities
carried out by and through the Center and the policies
respecting such activities.
(2) The advisory council for the Center may recommend to
the Secretary acceptance, in accordance with section 231, of
conditional gifts for study, investigations, and research and
for the acquisition of grounds or construction, equipping, or
maintenance of facilities for the Center.
(3) The advisory council for the Center--
(A)(i) may make recommendations to the Director of
the Center respecting research conducted at the Center,
(ii) may review applications for grants and
cooperative agreements for research or training and
recommend for approval applications for projects which
show promise of making valuable contributions to human
knowledge, and
(iii) may review any grant, contract, or
cooperative agreement proposed to be made or entered
into by the Center;
(B) may collect, by correspondence or by personal
investigation, information as to studies which are
being carried on in the United States or any other
country as to the diseases, disorders, or other aspects
of human health with respect to which the Center is
concerned and with the approval of the Director of the
Center make available such information through
appropriate publications for the benefit of public and
private health entities and health professions
personnel and scientists and for the information of the
general public; and
(C) may appoint subcommittees and convene workshops
and conferences.
(b)(1) The advisory council shall consist of ex officio
members and not more than eighteen members appointed by the
Secretary.
(2) The ex officio members of the advisory council shall
consist of--
(A) the Secretary, the Director of NIH, the
Director of the Center, the Chief Medical Director of
the Department of Veterans Affairs, and the Assistant
Secretary of Defense for Health Affairs (or the
designees of such officers), and
(B) such additional officers or employees of the
United States as the Secretary determines necessary for
the advisory council to effectively carry out its
functions.
(3) The members of the advisory council who are not ex
officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by
the Secretary from among the leading representatives of
the health and scientific disciplines (including public
health and the behavioral or social sciences) relevant
to the activities of the Center.
(B) One-third of the members shall be appointed by
the Secretary from the general public and shall include
leaders in fields of public policy, law, health policy,
economics, and management.
(4) Members of the advisory council who are officers or
employees of the United States shall not receive any
compensation for service on the advisory council. The other
members of the advisory council shall receive, for each day
(including traveltime) they are engaged in the performance of
the functions of the advisory council, compensation at rates
not to exceed the daily equivalent of the annual rate in effect
for grade GS-18 of the General Schedule.
(c) The term of office of an appointed member of the
advisory council is four years, except that any member
appointed to fill a vacancy for an unexpired term shall be
appointed for the remainder of such term and the Secretary
shall make appointments to an advisory council in such a manner
as to ensure that the terms of the members do not all expire in
the same year. A member may serve after the expiration of the
member's term until a successor has taken office. A member who
has been appointed for a term of four years may not be
reappointed to an advisory council before two years from the
date of expiration of such term of office. If a vacancy occurs
in the advisory council among the appointed members, the
Secretary shall make an appointment to fill the vacancy within
90 days from the date the vacancy occurs.
(d) The chairman of the advisory council shall be selected
by the Secretary from among the appointed members, except that
the Secretary may select the Director of the Center to be the
chairman of the advisory council. The term of office of the
chairman shall be two years.
(e) The advisory council shall meet at the call of the
chairman or upon the request of the Director of the Center, but
at least three times each fiscal year. The location of the
meetings of the advisory council is subject to the approval of
the Director of the Center.
(f) The Director of the Center shall designate a member of
the staff of the Center to serve as the executive secretary of
the advisory council. The Director of the Center shall make
available to the advisory council such staff, information, and
other assistance as it may require to carry out its functions.
The Director of the Center shall provide orientation and
training for new members of the advisory council to provide
them with such information and training as may be appropriate
for their effective participation in the functions of the
advisory council.
(g) The advisory council may prepare, for inclusion in the
biennial report made under section 481, (1) comments respecting
the activities of the advisory council in the fiscal years
respecting which the report is prepared, (2) comments on the
progress of the Center in meeting its objectives, and (3)
recommendations respecting the future directions and program
and policy emphasis of the Center. The advisory council may
prepare such additional reports as it may determine
appropriate.
(h) This section does not terminate the membership of the
advisory council for the Center which was in existence on the
date of enactment of the Health Research Extension Act of 1985.
After such date--
(1) the Secretary shall make appointments to such
advisory council in such a manner as to bring about as
soon as practicable the composition for such council
prescribed by this section;
(2) the advisory council shall organize itself in
accordance with this section and exercise the functions
prescribed by this section; and
(3) the Director of the Center shall perform for
such advisory council the functions prescribed by this
section.
biennial report
Sec. 481. [287a-1] The Director of the Center, after
consultation with the advisory council for the Center, shall
prepare for inclusion in the biennial report made under section
403 a biennial report which shall consist of a description of
the activities of the Center and program policies of the
Director of the Center in the fiscal years respecting which the
report is prepared. The Director of the Center may prepare such
additional reports as the Director determines appropriate. The
Director of the Center shall provide the advisory council of
the Center an opportunity for the submission of the written
comments referred to in section 480(g).
SEC. 481A. [287A-2] BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
(a) Modernization and Construction of Facilities.--
(1) In general.--The Director of NIH, acting
through the Director of the Center or the Director of
the National Institute of Allergy and Infectious
Diseases, may make grants or contracts to public and
nonprofit private entities to expand, remodel,
renovate, or alter existing research facilities or
construct new research facilities, subject to the
provisions of this section.
(2) Construction and cost of construction.--For
purposes of this section, the terms ``construction''
and ``cost of construction'' include the construction
of new buildings and the expansion, renovation,
remodeling, and alteration of existing buildings,
including architects' fees, but do not include the cost
of acquisition of land or off-site improvements.
(b) Scientific and Technical Review Boards for Merit-Based
Review of Proposals.--
(1) In general: approval as precondition to
grants.--
(A) Establishment.--There is established
within the Center a Scientific and Technical
Review Board on Biomedical and Behavioral
Research Facilities (referred to in this
section as the ``Board'').
(B) Requirement.--The Director of the
Center may approve an application for a grant
under subsection (a) only if the Board has
under paragraph (2) recommended the application
for approval.
(2) Duties.--
(A) Advice.--The Board shall provide advice
to the Director of the Center and the advisory
council established under section 480 (in this
section referred to as the ``Advisory
Council'') in carrying out this section.
(B) Determination of merit.--In carrying
out subparagraph (A), the Board shall make a
determination of the merit of each application
submitted for a grant under subsection (a),
after consideration of the requirements
established in subsection (c), and shall report
the results of the determination to the
Director of the Center and the Advisory
Council. Such determinations shall be conducted
in a manner consistent with procedures
established under section 492.
(C) Amount.--In carrying out subparagraph
(A), the Board shall, in the case of
applications recommended for approval, make
recommendations to the Director and the
Advisory Council on the amount that should be
provided under the grant.
(D) Annual report.--In carrying out
subparagraph (A), the Board shall prepare an
annual report for the Director of the Center
and the Advisory Council describing the
activities of the Board in the fiscal year for
which the report is made. Each such report
shall be available to the public, and shall--
(i) summarize and analyze
expenditures made under this section;
(ii) provide a summary of the
types, numbers, and amounts of
applications that were recommended for
grants under subsection (a) but that
were not approved by the Director of
the Center; and
(iii) contain the recommendations
of the Board for any changes in the
administration of this section.
(3) Membership.--
(A) In general.--Subject to subparagraph
(B), the Board shall be composed of 15 members
to be appointed by the Director of the Center,
and such ad-hoc or temporary members as the
Director of the Center determines to be
appropriate. All members of the Board,
including temporary and ad-hoc members, shall
be voting members.
(B) Limitation.--Not more than three
individuals who are officers or employees of
the Federal Government may serve as members of
the Board.
(4) Certain requirements regarding membership.--In
selecting individuals for membership on the Board, the
Director of the Center shall ensure that the members
are individuals who, by virtue of their training or
experience, are eminently qualified to perform peer
review functions. In selecting such individuals for
such membership, the Director of the Center shall
ensure that the members of the Board collectively--
(A) are experienced in the planning,
construction, financing, and administration of
entities that conduct biomedical or behavioral
research sciences;
(B) are knowledgeable in making
determinations of the need of entities for
biomedical or behavioral research facilities,
including such facilities for the dentistry,
nursing, pharmacy, and allied health
professions;
(C) are knowledgeable in evaluating the
relative priorities for applications for grants
under subsection (a) in view of the overall
research needs of the United States; and
(D) are experienced with emerging centers
of excellence, as described in subsection
(c)(2).
(5) Certain authorities.--
(A) Workshops and conferences.--In carrying
out paragraph (2), the Board may convene
workshops and conferences, and collect data as
the Board considers appropriate.
(B) Subcommittees.--In carrying out
paragraph (2), the Board may establish
subcommittees within the Board. Such
subcommittees may hold meetings as determined
necessary to enable the subcommittee to carry
out its duties.
(6) Terms.--
(A) In general.--Except as provided in
subparagraph (B), each appointed member of the
Board shall hold office for a term of 4 years.
Any member appointed to fill a vacancy
occurring prior to the expiration of the term
for which such member's predecessor was
appointed shall be appointed for the remainder
of the term of the predecessor.
(B) Staggered terms.--Members appointed to
the Board shall serve staggered terms as
specified by the Director of the Center when
making the appointments.
(C) Reappointment.--No member of the Board
shall be eligible for reappointment to the
Board until 1 year has elapsed after the end of
the most recent term of the member.
(7) Compensation.--Members of the Board who are not
officers or employees of the United States shall
receive for each day the members are engaged in the
performance of the functions of the Board compensation
at the same rate received by members of other national
advisory councils established under this title.
(c) Requirements for Grants.--
(1) In general.--The Director of the Center or the
Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection
(a) only if the applicant for the grant meets the
following conditions:
(A) The applicant is determined by such
Director to be competent to engage in the type
of research for which the proposed facility is
to be constructed.
(B) The applicant provides assurances
satisfactory to the Director that--
(i) for not less than 20 years
after completion of the construction
involved, the facility will be used for
the purposes of the research for which
it is to be constructed;
(ii) sufficient funds will be
available to meet the non-Federal share
of the cost of constructing the
facility;
(iii) sufficient funds will be
available, when construction is
completed, for the effective use of the
facility for the research for which it
is being constructed; and
(iv) the proposed construction will
expand the applicant's capacity for
research, or is necessary to improve or
maintain the quality of the applicant's
research.
(C) The applicant meets reasonable
qualifications established by the Director with
respect to--
(i) the relative scientific and
technical merit of the applications,
and the relative effectiveness of the
proposed facilities, in expanding the
capacity for biomedical or behavioral
research and in improving the quality
of such research;
(ii) the quality of the research or
training, or both, to be carried out in
the facilities involved;
(iii) the congruence of the
research activities to be carried out
within the facility with the research
and investigator manpower needs of the
United States; and
(iv) the age and condition of
existing research facilities.
(D) The applicant has demonstrated a
commitment to enhancing and expanding the
research productivity of the applicant.
(2) Institutions of emerging excellence.--From the
amount appropriated to carry out this section for a
fiscal year up to $50,000,000, the Director of the
Center shall make available 25 percent of such amount,
and from the amount appropriated to carry out this
section for a fiscal year that is over $50,000,000, the
Director of the Center shall make available up to 25
percent of such amount, for grants under subsection (a)
to applicants that in addition to meeting the
requirements established in paragraph (1), have
demonstrated emerging excellence in biomedical or
behavioral research, as follows:
(A) The applicant has a plan for research
or training advancement and possesses the
ability to carry out the plan.
(B) The applicant carries out research and
research training programs that have a special
relevance to a problem, concern, or unmet
health need of the United States.
(C) The applicant has been productive in
research or research development and training.
(D) The applicant--
(i) has been designated as a center
of excellence under section 739;
(ii) is located in a geographic
area whose population includes a
significant number of individuals with
health status deficit, and the
applicant provides health services to
such individuals; or
(iii) is located in a geographic
area in which a deficit in health care
technology, services, or research
resources may adversely affect the
health status of the population of the
area in the future, and the applicant
is carrying out activities with respect
to protecting the health status of such
population.
(d) Requirement of Application.--The Director of the Center
or the Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection (a) only
if an application for the grant is submitted to the Director
and the application is in such form, is made in such manner,
and contains such agreements, assurances, and information as
the Director determines to be necessary to carry out this
section.
(e) Amount of Grant; Payments.--
(1) Amount.--The amount of any grant awarded under
subsection (a) shall be determined by the Director of
the Center or the Director of the National Institute of
Allergy and Infectious Diseases, except that such
amount shall not exceed--
(A) 50 percent (or, in the case of the
Institute, 75 percent) of the necessary cost of
the construction of a proposed facility as
determined by the Director; or
(B) in the case of a multipurpose facility,
40 percent (or, in the case of the Institute,
75 percent) of that part of the necessary cost
of construction that the Director determines to
be proportionate to the contemplated use of the
facility.
(2) Reservation of amounts.--On the approval of any
application for a grant under subsection (a), the
Director of the Center or the Director of the National
Institute of Allergy and Infectious Diseases shall
reserve, from any appropriation available for such
grants, the amount of such grant, and shall pay such
amount, in advance or by way of reimbursement, and in
such installments consistent with the construction
progress, as the Director may determine appropriate.
The reservation of any amount by the Director under
this paragraph may be amended by the Director, either
on the approval of an amendment of the application or
on the revision of the estimated cost of construction
of the facility.
(3) Exclusion of certain costs.--In determining the
amount of any grant under subsection (a), there shall
be excluded from the cost of construction an amount
equal to the sum of--
(A) the amount of any other Federal grant
that the applicant has obtained, or is assured
of obtaining, with respect to construction that
is to be financed in part by a grant authorized
under this section; and
(B) the amount of any non-Federal funds
required to be expended as a condition of such
other Federal grant.
(4) Waiver of limitations.--The limitations imposed
under paragraph (1) may be waived at the discretion of
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
for applicants meeting the conditions described in
subsection (c).
(f ) Recapture of Payments.--If, not later than 20 years
after the completion of construction for which a grant has been
awarded under subsection (a)--
(1) in the case of an award by the Director of the
Center, the applicant or other owner of the facility
shall cease to be a public or non profit private
entity; or
(2) the facility shall cease to be used for the
research purposes for which it was constructed (unless
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
determines, in accordance with regulations, that there
is good cause for releasing the applicant or other
owner from obligation to do so),
the United States shall be entitled to recover from the
applicant or other owner of the facility the amount bearing the
same ratio to the current value (as determined by an agreement
between the parties or by action brought in the United States
District Court for the district in which such facility is
situated) of the facility as the amount of the Federal
participation bore to the cost of the construction of such
facility.
(g) Guidelines.--Not later than 6 months after the date of
the enactment of this section, the Director of the Center,
after consultation with the Advisory Council, shall issue
guidelines with respect to grants under subsection (a).
construction of regional centers for research on primates
Sec. 481B. [287a-3] (a) With respect to activities carried
out by the National Center for Research Resources to support
regional centers for research on primates, the Director of NIH
may, for each of the fiscal years 1994 through 1996 \1\,
reserve from the amounts appropriated to carry out section 481A
up to $2,500,000 for the purpose of making awards of grants and
contracts to public or nonprofit private entities to construct,
renovate, or otherwise improve such regional centers. The
reservation of such amounts for any fiscal year is subject to
the availability of qualified applicants for such awards.
---------------------------------------------------------------------------
\1\ The probable intent of the Congress is that the authorization
of appropriations be for fiscals year 2000 through 2002. Section 304 of
Public Law 106-505 (114 Stat. 2335) provided that section 481B(a) ``is
amended by striking `1994' and all that follows through `$5,000,000'
and inserting `2000 through 2002, reserve from the amounts appropriated
under section 481A(i) such sums as necessary'''. The amendment cannot
be executed because a term referenced in the instructions,
``$5,000,000'', does not appear in section 481B(a). The term
``2,500,000'' probably should have been referenced.
---------------------------------------------------------------------------
(b) The Director of NIH may not make a grant or enter into
a contract under subsection (a) unless the applicant for such
assistance agrees, with respect to the costs to be incurred by
the applicant in carrying out the purpose described in such
subsection, to make available (directly or through donations
from public or private entities) non-Federal contributions in
cash toward such costs in an amount equal to not less than $1
for each $4 of Federal funds provided in such assistance.
SEC. 481C. [287A-3A] SANCTUARY SYSTEM FOR SURPLUS CHIMPANZEES.
(a) In General.--The Secretary shall provide for the
establishment and operation in accordance with this section of
a system to provide for the lifetime care of chimpanzees that
have been used, or were bred or purchased for use, in research
conducted or supported by the National Institutes of Health,
the Food and Drug Administration, or other agencies of the
Federal Government, and with respect to which it has been
determined by the Secretary that the chimpanzees are not needed
for such research (in this section referred to as ``surplus
chimpanzees'').
(b) Administration of Sanctuary System.--The Secretary
shall carry out this section, including the establishment of
regulations under subsection (d), in consultation with the
board of directors of the nonprofit private entity that
receives the contract under subsection (e) (relating to the
operation of the sanctuary system).
(c) Acceptance of Chimpanzees Into System.--All surplus
chimpanzees owned by the Federal Government shall be accepted
into the sanctuary system. Subject to standards under
subsection (d)(4), any chimpanzee that is not owned by the
Federal Government can be accepted into the system if the owner
transfers to the sanctuary system title to the chimpanzee.
(d) Standards for Permanent Retirement of Surplus
Chimpanzees.--
(1) In general.--Not later than 180 days after the
date of the enactment of this section, the Secretary
shall by regulation establish standards for operating
the sanctuary system to provide for the permanent
retirement of surplus chimpanzees. In establishing the
standards, the Secretary shall consider the
recommendations of the board of directors of the
nonprofit private entity that receives the contract
under subsection (e), and shall consider the
recommendations of the National Research Council
applicable to surplus chimpanzees that are made in the
report published in 1997 and entitled ``Chimpanzees in
Research--Strategies for Their Ethical Care,
Management, and Use''.
(2) Chimpanzees accepted into system.--With respect
to chimpanzees that are accepted into the sanctuary
system, standards under paragraph (1) shall include the
following:
(A) A prohibition that the chimpanzees may
not be used for research, except as authorized
under paragraph (3).
(B) Provisions regarding the housing of the
chimpanzees.
(C) Provisions regarding the behavioral
well-being of the chimpanzees.
(D) A requirement that the chimpanzees be
cared for in accordance with the Animal Welfare
Act.
(E) A requirement that the chimpanzees be
prevented from breeding.
(F) A requirement that complete histories
be maintained on the health and use in research
of the chimpanzees.
(G) A requirement that the chimpanzees be
monitored for the purpose of promptly detecting
the presence in the chimpanzees of any
condition that may be a threat to the public
health or the health of other chimpanzees.
(H) A requirement that chimpanzees posing
such a threat be contained in accordance with
applicable recommendations of the Director of
the Centers for Disease Control and Prevention.
(I) A prohibition that none of the
chimpanzees may be subjected to euthanasia,
except as in the best interests of the
chimpanzee involved, as determined by the
system and an attending veterinarian.
(J) A prohibition that the chimpanzees may
not be discharged from the system.
(K) A provision that the Secretary may, in
the discretion of the Secretary, accept into
the system chimpanzees that are not surplus
chimpanzees.
(L) Such additional standards as the
Secretary determines to be appropriate.
(3) Restrictions regarding research.--
(A) In general.--For purposes of paragraph
(2)(A), standards under paragraph (1) shall
provide that a chimpanzee accepted into the
sanctuary system may not be used for studies or
research, except that the chimpanzee may be
used for noninvasive behavioral studies or
medical studies based on information collected
during the course of normal veterinary care
that is provided for the benefit of the
chimpanzee, provided that any such study
involves minimal physical and mental harm,
pain, distress, and disturbance to the
chimpanzee and the social group in which the
chimpanzee lives.
(B) Additional restriction.--For purposes
of paragraph (2)(A), a condition for the use in
studies or research of a chimpanzee accepted
into the sanctuary system is (in addition to
conditions under subparagraph (A) of this
paragraph) that the applicant for such use has
not been fined for, or signed a consent decree
for, any violation of the Animal Welfare Act.
(4) Non-federal chimpanzees offered for acceptance
into system.--With respect to a chimpanzee that is not
owned by the Federal Government and is offered for
acceptance into the sanctuary system, standards under
paragraph (1) shall include the following:
(A) A provision that the Secretary may
authorize the imposition of a fee for accepting
such chimpanzee into the system, except as
follows:
(i) Such a fee may not be imposed
for accepting the chimpanzee if, on the
day before the date of the enactment of
this section, the chimpanzee was owned
by the nonprofit private entity that
receives the contract under subsection
(e) or by any individual sanctuary
facility receiving a subcontract or
grant under subsection (e)(1).
(ii) Such a fee may not be imposed
for accepting the chimpanzee if the
chimpanzee is owned by an entity that
operates a primate center, and if the
chimpanzee is housed in the primate
center pursuant to the program for
regional centers for research on
primates that is carried out by the
National Center for Research Resources.
Any fees collected under this subparagraph are
available to the Secretary for the costs of
operating the system. Any other fees received
by the Secretary for the long-term care of
chimpanzees (including any Federal fees that
are collected for such purpose and are
identified in the report under section 3 of the
Chimpanzee Health Improvement, Maintenance, and
Protection Act) are available for operating the
system, in addition to availability for such
other purposes as may be authorized for the use
of the fees.
(B) A provision that the Secretary may deny
such chimpanzee acceptance into the system if
the capacity of the system is not sufficient to
accept the chimpanzee, taking into account the
physical capacity of the system; the financial
resources of the system; the number of
individuals serving as the staff of the system,
including the number of professional staff; the
necessity of providing for the safety of the
staff and of the public; the necessity of
caring for accepted chimpanzees in accordance
with the standards under paragraph (1); and
such other factors as may be appropriate.
(C) A provision that the Secretary may deny
such chimpanzee acceptance into the system if a
complete history of the health and use in
research of the chimpanzee is not available to
the Secretary.
(D) Such additional standards as the
Secretary determines to be appropriate.
(e) Award of Contract for Operation of System.--
(1) In general.--Subject to the availability of
funds pursuant to subsection (g), the Secretary shall
make an award of a contract to a nonprofit private
entity under which the entity has the responsibility of
operating (and establishing, as applicable) the
sanctuary system and awarding subcontracts or grants to
individual sanctuary facilities that meet the standards
under subsection (d).
(2) Requirements.--The Secretary may make an award
under paragraph (1) to a nonprofit private entity only
if the entity meets the following requirements:
(A) The entity has a governing board of
directors that is composed and appointed in
accordance with paragraph (3) and is
satisfactory to the Secretary.
(B) The terms of service for members of
such board are in accordance with paragraph
(3).
(C) The members of the board serve without
compensation. The members may be reimbursed for
travel, subsistence, and other necessary
expenses incurred in carrying out the duties of
the board.
(D) The entity has an executive director
meeting such requirements as the Secretary
determines to be appropriate.
(E) The entity makes the agreement
described in paragraph (4) (relating to non-
Federal contributions).
(F) The entity agrees to comply with
standards under subsection (d).
(G) The entity agrees to make necropsy
reports on chimpanzees in the sanctuary system
available on a reasonable basis to persons who
conduct biomedical or behavioral research, with
priority given to such persons who are Federal
employees or who receive financial support from
the Federal Government for research.
(H) Such other requirements as the
Secretary determines to be appropriate.
(3) Board of directors.--For purposes of
subparagraphs (A) and (B) of paragraph (2):
(A) The governing board of directors of the
nonprofit private entity involved is composed
and appointed in accordance with this paragraph
if the following conditions are met:
(i) Such board is composed of not
more than 13 voting members.
(ii) Such members include
individuals with expertise and
experience in the science of managing
captive chimpanzees (including primate
veterinary care), appointed from among
individuals endorsed by organizations
that represent individuals in such
field.
(iii) Such members include
individuals with expertise and
experience in the field of animal
protection, appointed from among
individuals endorsed by organizations
that represent individuals in such
field.
(iv) Such members include
individuals with expertise and
experience in the zoological field
(including behavioral primatology),
appointed from among individuals
endorsed by organizations that
represent individuals in such field.
(v) Such members include
individuals with expertise and
experience in the field of the business
and management of nonprofit
organizations, appointed from among
individuals endorsed by organizations
that represent individuals in such
field.
(vi) Such members include
representatives from entities that
provide accreditation in the field of
laboratory animal medicine.
(vii) Such members include
individuals with expertise and
experience in the field of containing
biohazards.
(viii) Such members include an
additional member who serves as the
chair of the board, appointed from
among individuals who have been
endorsed for purposes of clause (ii),
(iii), (iv), or (v).
(ix) None of the members of the
board has been fined for, or signed a
consent decree for, any violation of
the Animal Welfare Act.
(B) The terms of service for members of the
board of directors are in accordance with this
paragraph if the following conditions are met:
(i) The term of the chair of the
board is 3 years.
(ii) The initial members of the
board select, by a random method, one
member from each of the six fields
specified in subparagraph (A) to serve
a term of 2 years and (in addition to
the chair) one member from each of such
fields to serve a term of 3 years.
(iii) After the initial terms under
clause (ii) expire, each member of the
board (other than the chair) is
appointed to serve a term of 2 years.
(iv) An individual whose term of
service expires may be reappointed to
the board.
(v) A vacancy in the membership of
the board is filled in the manner in
which the original appointment was
made.
(vi) If a member of the board does
not serve the full term applicable to
the member, the individual appointed to
fill the resulting vacancy is appointed
for the remainder of the term of the
predecessor member.
(4) Requirement of matching funds.--The agreement
required in paragraph (2)(E) for a nonprofit private
entity (relating to the award of the contract under
paragraph (1)) is an agreement that, with respect to
the costs to be incurred by the entity in establishing
and operating the sanctuary system, the entity will
make available (directly or through donations from
public or private entities) non-Federal contributions
toward such costs, in cash or in kind, in an amount not
less than the following, as applicable:
(A) For expenses associated with
establishing the sanctuary system (as
determined by the Secretary), 10 percent of
such costs ($1 for each $9 of Federal funds
provided under the contract under paragraph
(1)).
(B) For expenses associated with operating
the sanctuary system (as determined by the
Secretary), 25 percent of such costs ($1 for
each $3 of Federal funds provided under such
contract).
(5) Establishment of contract entity.--If the
Secretary determines that an entity meeting the
requirements of paragraph (2) does not exist, not later
than 60 days after the date of the enactment of this
section, the Secretary shall, for purposes of paragraph
(1), make a grant for the establishment of such an
entity, including paying the cost of incorporating the
entity under the law of one of the States.
(f ) Definitions.--For purposes of this section:
(1) Permanent retirement.--The term ``permanent
retirement'', with respect to a chimpanzee that has
been accepted into the sanctuary system, means that
under subsection (a) the system provides for the
lifetime care of the chimpanzee, that under subsection
(d)(2) the system does not permit the chimpanzee to be
used in research (except as authorized under subsection
(d)(3)) or to be euthanized (except as provided in
subsection (d)(2)(I)), that under subsection (d)(2) the
system will not discharge the chimpanzee from the
system, and that under such subsection the system
otherwise cares for the chimpanzee.
(2) Sanctuary system.--The term ``sanctuary
system'' means the system described in subsection (a).
(3) Secretary.--The term ``Secretary'' means the
Secretary of Health and Human Services.
(4) Surplus chimpanzees.--The term ``surplus
chimpanzees'' has the meaning given that term in
subsection (a).
(g) Funding.--
(1) In general.--Of the amount appropriated under
this Act for fiscal year 2001 and each subsequent
fiscal year, the Secretary, subject to paragraph (2),
shall reserve a portion for purposes of the operation
(and establishment, as applicable) of the sanctuary
system and for purposes of paragraph (3), except that
the Secretary may not for such purposes reserve any
further funds from such amount after the aggregate
total of the funds so reserved for such fiscal years
reaches $30,000,000. The purposes for which funds
reserved under the preceding sentence may be expended
include the construction and renovation of facilities
for the sanctuary system.
(2) Limitation.--Funds may not be reserved for a
fiscal year under paragraph (1) unless the amount
appropriated under this Act for such year equals or
exceeds the amount appropriated under this Act for
fiscal year 1999.
(3) Use of funds for other compliant facilities.--
With respect to amounts reserved under paragraph (1)
for a fiscal year, the Secretary may use a portion of
such amounts to make awards of grants or contracts to
public or private entities operating facilities that,
as determined by the board of directors of the
nonprofit private entity that receives the contract
under subsection (e), provide for the retirement of
chimpanzees in accordance with the same standards that
apply to the sanctuary system pursuant to regulations
under subsection (d). Such an award may be expended for
the expenses of operating the facilities involved.
SEC. 481D. [287A-2] GENERAL CLINICAL RESEARCH CENTERS.
(a) Grants.--The Director of the National Center for
Research Resources shall award grants for the establishment of
general clinical research centers to provide the infrastructure
for clinical research including clinical research training and
career enhancement. Such centers shall support clinical studies
and career development in all settings of the hospital or
academic medical center involved.
(b) Activities.--In carrying out subsection (a), the
Director of National Institutes of Health shall expand the
activities of the general clinical research centers through the
increased use of telecommunications and telemedicine
initiatives.
Subpart 2--John E. Fogarty International Center for Advanced Study in
the Health Sciences
general purpose
Sec. 482. [287b] The general purpose of the John E. Fogarty
International Center for Advanced Study in the Health Sciences
is to--
(1) facilitate the assembly of scientists and
others in the biomedical, behavioral, and related
fields for discussion, study, and research relating to
the development of health science internationally;
(2) provide research programs, conferences, and
seminars to further international cooperation and
collaboration in the life sciences;
(3) provide postdoctorate fellowships for research
training in the United States and abroad and promote
exchanges of senior scientists between the United
States and other countries;
(4) coordinate the activities of the National
Institutes of Health concerned with the health sciences
internationally; and
(5) receive foreign visitors to the National
Institutes of Health.
Subpart 4--Office of Dietary Supplements \1\
---------------------------------------------------------------------------
\1\ Subpart 3 of this part was transferred and redesignated as
subpart 19 of part C by section 101(c) of Public Law 109-482.
---------------------------------------------------------------------------
SEC. 485C. [287C-11] DIETARY SUPPLEMENTS.
(a) Establishment.--The Secretary shall establish an Office
of Dietary Supplements within the National Institutes of
Health.
(b) Purpose.--The purposes of the Office are--
(1) to explore more fully the potential role of
dietary supplements as a significant part of the
efforts of the United States to improve health care;
and
(2) to promote scientific study of the benefits of
dietary supplements in maintaining health and
preventing chronic disease and other health-related
conditions.
(c) Duties.--The Director of the Office of Dietary
Supplements shall--
(1) conduct and coordinate scientific research
within the National Institutes of Health relating to
dietary supplements and the extent to which the use of
dietary supplements can limit or reduce the risk of
diseases such as heart disease, cancer, birth defects,
osteoporosis, cataracts, or prostatism;
(2) collect and compile the results of scientific
research relating to dietary supplements, including
scientific data from foreign sources or the Office of
Alternative Medicine;
(3) serve as the principal advisor to the Secretary
and to the Assistant Secretary for Health and provide
advice to the Director of the National Institutes of
Health, the Director of the Centers for Disease Control
and Prevention, and the Commissioner of Food and Drugs
on issues relating to dietary supplements including--
(A) dietary intake regulations;
(B) the safety of dietary supplements;
(C) claims characterizing the relationship
between--
(i) dietary supplements; and
(ii)(I) prevention of disease or
other health-related conditions; and
(II) maintenance of health; and
(D) scientific issues arising in connection
with the labeling and composition of dietary
supplements;
(4) compile a database of scientific research on
dietary supplements and individual nutrients; and
(5) coordinate funding relating to dietary
supplements for the National Institutes of Health.
(d) Definition.--As used in this section, the term
``dietary supplement'' has the meaning given the term in
section 201(ff) of the Federal Food, Drug, and Cosmetic Act.
Subpart 5--National Center for Complementary and Alternative Medicine
SEC. 485D. [287C-21] PURPOSE OF CENTER.
(a) In General.--The general purposes of the National
Center for Complementary and Alternative Medicine (in this
subpart referred to as the ``Center'') are the conduct and
support of basic and applied research (including both
intramural and extramural research), research training, the
dissemination of health information, and other programs with
respect to identifying, investigating, and validating
complementary and alternative treatment, diagnostic and
prevention modalities, disciplines and systems. The Center
shall be headed by a director, who shall be appointed by the
Secretary. The Director of the Center shall report directly to
the Director of NIH.
(b) Advisory Council.--The Secretary shall establish an
advisory council for the Center in accordance with section 406,
except that at least half of the members of the advisory
council who are not ex officio members shall include
practitioners licensed in one or more of the major systems with
which the Center is concerned, and at least 3 individuals
representing the interests of individual consumers of
complementary and alternative medicine.
(c) Complement to Conventional Medicine.--In carrying out
subsection (a), the Director of the Center shall, as
appropriate, study the integration of alternative treatment,
diagnostic and prevention systems, modalities, and disciplines
with the practice of conventional medicine as a complement to
such medicine and into health care delivery systems in the
United States.
(d) Appropriate Scientific Expertise and Coordination With
Institutes and Federal Agencies.--The Director of the Center,
after consultation with the advisory council for the Center and
the division of research grants, shall ensure that scientists
with appropriate expertise in research on complementary and
alternative medicine are incorporated into the review,
oversight, and management processes of all research projects
and other activities funded by the Center. In carrying out this
subsection, the Director of the Center, as necessary, may
establish review groups with appropriate scientific expertise.
The Director of the Center shall coordinate efforts with other
Institutes and Federal agencies to ensure appropriate
scientific input and management.
(e) Evaluation of Various Disciplines and Systems.--In
carrying out subsection (a), the Director of the Center shall
identify and evaluate alternative and complementary medical
treatment, diagnostic and prevention modalities in each of the
disciplines and systems with which the Center is concerned,
including each discipline and system in which accreditation,
national certification, or a State license is available.
(f) Ensuring High Quality, Rigorous Scientific Review.--In
order to ensure high quality, rigorous scientific review of
complementary and alternative, diagnostic and prevention
modalities, disciplines and systems, the Director of the Center
shall conduct or support the following activities:
(1) Outcomes research and investigations.
(2) Epidemiological studies.
(3) Health services research.
(4) Basic science research.
(5) Clinical trials.
(6) Other appropriate research and investigational
activities.
The Director of NIH, in coordination with the Director of the
Center, shall designate specific personnel in each Institute to
serve as full-time liaisons with the Center in facilitating
appropriate coordination and scientific input.
(g) Data System; Information Clearinghouse.--
(1) Data system.--The Director of the Center shall
establish a bibliographic system for the collection,
storage, and retrieval of worldwide research relating
to complementary and alternative treatment, diagnostic
and prevention modalities, disciplines and systems.
Such a system shall be regularly updated and publicly
accessible.
(2) Clearinghouse.--The Director of the Center
shall establish an information clearinghouse to
facilitate and enhance, through the effective
dissemination of information, knowledge and
understanding of alternative medical treatment,
diagnostic and prevention practices by health
professionals, patients, industry, and the public.
(h) Research Centers.--The Director of the Center, after
consultation with the advisory council for the Center, shall
provide support for the development and operation of
multipurpose centers to conduct research and other activities
described in subsection (a) with respect to complementary and
alternative treatment, diagnostic and prevention modalities,
disciplines and systems. The provision of support for the
development and operation of such centers shall include
accredited complementary and alternative medicine research and
education facilities.
(i) Availability of Resources.--After consultation with the
Director of the Center, the Director of NIH shall ensure that
resources of the National Institutes of Health, including
laboratory and clinical facilities, fellowships (including
research training fellowship and junior and senior clinical
fellowships), and other resources are sufficiently available to
enable the Center to appropriately and effectively carry out
its duties as described in subsection (a). The Director of NIH,
in coordination with the Director of the Center, shall
designate specific personnel in each Institute to serve as
full-time liaisons with the Center in facilitating appropriate
coordination and scientific input.
(j) Availability of Appropriations.--Amounts appropriated
to carry out this section for fiscal year 1999 are available
for obligation through September 30, 2001. Amounts appropriated
to carry out this section for fiscal year 2000 are available
for obligation through September 30, 2001.
Part F--Research on Women's Health
SEC. 486. [287D] OFFICE OF RESEARCH ON WOMEN'S HEALTH.
(a) Establishment.--There is established within the Office
of the Director of NIH an office to be known as the Office of
Research on Women's Health (in this part referred to as the
``Office''). The Office shall be headed by a director, who
shall be appointed by the Director of NIH and who shall report
directly to the Director.
(b) Purpose.--The Director of the Office shall--
(1) identify projects of research on women's health
that should be conducted or supported by the national
research institutes;
(2) identify multidisciplinary research relating to
research on women's health that should be so conducted
or supported;
(3) carry out paragraphs (1) and (2) with respect
to the aging process in women, with priority given to
menopause;
(4) promote coordination and collaboration among
entities conducting research identified under any of
paragraphs (1) through (3);
(5) encourage the conduct of such research by
entities receiving funds from the national research
institutes;
(6) recommend an agenda for conducting and
supporting such research;
(7) promote the sufficient allocation of the
resources of the national research institutes for
conducting and supporting such research;
(8) assist in the administration of section 492B
with respect to the inclusion of women as subjects in
clinical research; and
(9) prepare the report required in section 486B.
(c) Coordinating Committee.--
(1) In carrying out subsection (b), the Director of
the Office shall establish a committee to be known as
the Coordinating Committee on Research on Women's
Health (in this subsection referred to as the
``Coordinating Committee'').
(2) The Coordinating Committee shall be composed of
the Directors of the national research institutes (or
the designees of the Directors).
(3) The Director of the Office shall serve as the
chair of the Coordinating Committee.
(4) With respect to research on women's health, the
Coordinating Committee shall assist the Director of the
Office in--
(A) identifying the need for such research,
and making an estimate each fiscal year of the
funds needed to adequately support the
research;
(B) identifying needs regarding the
coordination of research activities, including
intramural and extramural multidisciplinary
activities;
(C) supporting the development of
methodologies to determine the circumstances in
which obtaining data specific to women
(including data relating to the age of women
and the membership of women in ethnic or racial
groups) is an appropriate function of clinical
trials of treatments and therapies;
(D) supporting the development and
expansion of clinical trials of treatments and
therapies for which obtaining such data has
been determined to be an appropriate function;
and
(E) encouraging the national research
institutes to conduct and support such
research, including such clinical trials.
(d) Advisory Committee.--
(1) In carrying out subsection (b), the Director of
the Office shall establish an advisory committee to be
known as the Advisory Committee on Research on Women's
Health (in this subsection referred to as the
``Advisory Committee'').
(2) The Advisory Committee shall be composed of no
fewer than 12, and not more than 18 individuals, who
are not officers or employees of the Federal
Government. The Director of NIH shall make appointments
to the Advisory Committee from among physicians,
practitioners, scientists, and other health
professionals, whose clinical practice, research
specialization, or professional expertise includes a
significant focus on research on women's health. A
majority of the members of the Advisory Committee shall
be women.
(3) The Director of the Office shall serve as the
chair of the Advisory Committee.
(4) The Advisory Committee shall--
(A) advise the Director of the Office on
appropriate research activities to be
undertaken by the national research institutes
with respect to--
(i) research on women's health;
(ii) research on gender differences
in clinical drug trials, including
responses to pharmacological drugs;
(iii) research on gender
differences in disease etiology,
course, and treatment;
(iv) research on obstetrical and
gynecological health conditions,
diseases, and treatments; and
(v) research on women's health
conditions which require a
multidisciplinary approach;
(B) report to the Director of the Office on
such research;
(C) provide recommendations to such
Director regarding activities of the Office
(including recommendations on the development
of the methodologies described in subsection
(c)(4)(C) and recommendations on priorities in
carrying out research described in subparagraph
(A)); and
(D) assist in monitoring compliance with
section 492B regarding the inclusion of women
in clinical research.
(5)(A) The Advisory Committee shall prepare a
biennial report describing the activities of the
Committee, including findings made by the Committee
regarding--
(i) compliance with section 492B;
(ii) the extent of expenditures made for
research on women's health by the agencies of
the National Institutes of Health; and
(iii) the level of funding needed for such
research.
(B) The report required in subparagraph (A) shall
be submitted to the Director of NIH for inclusion in
the report required in section 403.
(e) Representation of Women Among Researchers.--The
Secretary, acting through the Assistant Secretary for Personnel
and in collaboration with the Director of the Office, shall
determine the extent to which women are represented among
senior physicians and scientists of the national research
institutes and among physicians and scientists conducting
research with funds provided by such institutes, and as
appropriate, carry out activities to increase the extent of
such representation.
(f) Definitions.--For purposes of this part:
(1) The term ``women's health conditions'', with
respect to women of all age, ethnic, and racial groups,
means all diseases, disorders, and conditions
(including with respect to mental health)--
(A) unique to, more serious, or more
prevalent in women;
(B) for which the factors of medical risk
or types of medical intervention are different
for women, or for which it is unknown whether
such factors or types are different for women;
or
(C) with respect to which there has been
insufficient clinical research involving women
as subjects or insufficient clinical data on
women.
(2) The term ``research on women's health'' means
research on women's health conditions, including
research on preventing such conditions.
SEC. 486A. [287D-1] NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH
ON WOMEN'S HEALTH.
(a) Data System.--
(1) The Director of NIH, in consultation with the
Director of the Office and the Director of the National
Library of Medicine, shall establish a data system for
the collection, storage, analysis, retrieval, and
dissemination of information regarding research on
women's health that is conducted or supported by the
national research institutes. Information from the data
system shall be available through information systems
available to health care professionals and providers,
researchers, and members of the public.
(2) The data system established under paragraph (1)
shall include a registry of clinical trials of
experimental treatments that have been developed for
research on women's health. Such registry shall include
information on subject eligibility criteria, sex, age,
ethnicity or race, and the location of the trial site
or sites. Principal investigators of such clinical
trials shall provide this information to the registry
within 30 days after it is available. Once a trial has
been completed, the principal investigator shall
provide the registry with information pertaining to the
results, including potential toxicities or adverse
effects associated with the experimental treatment or
treatments evaluated.
(b) Clearinghouse.--The Director of NIH, in consultation
with the Director of the Office and with the National Library
of Medicine, shall establish, maintain, and operate a program
to provide information on research and prevention activities of
the national research institutes that relate to research on
women's health.
SEC. 486B. [287D-2] BIENNIAL REPORT.
(a) In General.--With respect to research on women's
health, the Director of the Office shall, not later than
February 1, 1994, and biennially thereafter, prepare a report--
(1) describing and evaluating the progress made
during the preceding 2 fiscal years in research and
treatment conducted or supported by the National
Institutes of Health;
(2) describing and analyzing the professional
status of women physicians and scientists of such
Institutes, including the identification of problems
and barriers regarding advancements;
(3) summarizing and analyzing expenditures made by
the agencies of such Institutes (and by such Office)
during the preceding 2 fiscal years; and
(4) making such recommendations for legislative and
administrative initiatives as the Director of the
Office determines to be appropriate.
(b) Inclusion in Biennial Report of Director of NIH.--The
Director of the Office shall submit each report prepared under
subsection (a) to the Director of NIH for inclusion in the
report submitted to the President and the Congress under
section 403.
Part G--Awards and Training
Ruth L. Kirschstein National Research Service Awards \1\
Sec. 487. [288] (a)(1) The Secretary shall--
---------------------------------------------------------------------------
\1\ The typeface is so in law. See section 804(b) of Public Law
107-206 (116 Stat. 874).
---------------------------------------------------------------------------
(A) provide Ruth L. Kirschstein National Research
Service Awards \2\ for--
---------------------------------------------------------------------------
\2\ Section 804(c) of Public Law 107-206 (116 Stat. 874) provides
as follows:
``(c) Any reference in any law (other than this Act), regulation,
document, record, map, or other paper of the United States to `National
Research Service Awards' shall be considered to be a reference to `Ruth
L. Kirschstein National Research Service Awards'''.
---------------------------------------------------------------------------
(i) biomedical and behavioral research at
the National Institutes of Health in matters
relating to the cause, diagnosis, prevention,
and treatment of the diseases or other health
problems to which the activities of the
National Institutes of Health and
Administration \1\ are directed;
(ii) training at the National Institutes of
Health and at the Administration \1\ of
individuals to undertake such research;
(iii) biomedical and behavioral research
and health services research (including
research in primary medical care) at public and
nonprofit private entities; and
(iv) pre-doctoral and post-doctoral
training at public and private institutions of
individuals to undertake biomedical and
behavioral research;
(B) make grants to public and nonprofit private
institutions to enable such institutions to make Ruth
L. Kirschstein National Research Service Awards for
research (and training to undertake biomedical and
behavioral research) in the matters described in
subparagraph (A)(i) to individuals selected by such
institutions; and
(C) provide contracts for scholarships and loan
repayments in accordance with sections 487D and 487E,
subject to providing not more than an aggregate 50 such
contracts during the fiscal years 1994 through 1996.
A reference in this subsection to the National Institutes of
Health shall be considered to include the institutes, agencies,
divisions, and bureaus included in the National Institutes of
Health or under the Administration, \1\ as the case may be.
---------------------------------------------------------------------------
\1\ So in law. Section 163(b)(4)(B) of Public Law 102-321 (106
Stat. 376) struck a reference in paragraph (1) to the former Alcohol,
Drug Abuse, and Mental Health Administration, but failed to conform
related references.
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(2) Ruth L. Kirschstein National Research Service Awards
may not be used to support residency training of physicians and
other health professionals.
(3) In awarding Ruth L. Kirschstein National Research
Service Awards under this section, the Secretary shall take
account of the Nation's overall need for biomedical research
personnel by giving special consideration to physicians who
agree to undertake a minimum of two years of biomedical
research.
(4) The Secretary shall carry out paragraph (1) in a manner
that will result in the recruitment of women, and individuals
from disadvantaged backgrounds (including racial and ethnic
minorities), into fields of biomedical or behavioral research
and in the provision of research training to women and such
individuals.
(b)(1) No Ruth L. Kirschstein National Research Service
Award may be made by the Secretary to any individual unless--
(A) the individual has submitted to the Secretary
an application therefor and the Secretary has approved
the application;
(B) the individual provides, in such form and
manner as the Secretary shall by regulation prescribe,
assurances satisfactory to the Secretary that the
individual will meet the service requirement of
subsection (c); and
(C) in the case of a Ruth L. Kirschstein National
Research Service Award for a purpose described in
subsection (a)(1)(A)(iii), the individual has been
sponsored (in such manner as the Secretary may by
regulation require) by the institution at which the
research or training under the award will be conducted.
An application for an award shall be in such form, submitted in
such manner, and contain such information, as the Secretary may
by regulation prescribe.
(2) The making of grants under subsection (a)(1)(B) for
Ruth L. Kirschstein National Research Service Awards shall be
subject to review and approval by the appropriate advisory
councils within the Department of Health and Human Services (A)
whose activities relate to the research or training under the
awards, or (B) for the entity at which such research or
training will be conducted.
(3) No grant may be made under subsection (a)(1)(B) unless
an application therefor has been submitted to and approved by
the Secretary. Such application shall be in such form,
submitted in such manner, and contain such information, as the
Secretary may by regulation prescribe. Subject to the
provisions of this section (other than paragraph (1)), Ruth L.
Kirschstein National Research Service Awards made under a grant
under subsection (a)(1)(B) shall be made in accordance with
such regulations as the Secretary shall prescribe.
(4) The period of any Ruth L. Kirschstein National Research
Service Award made to any individual under subsection (a) may
not exceed--
(A) five years in the aggregate for pre-doctoral
training; and
(B) three years in the aggregate for post-doctoral
training;
unless the Secretary for good cause shown waives the
application of such limit to such individual.
(5) Ruth L. Kirschstein National Research Service Awards
shall provide for such stipends, tuition, fees, and allowances
(including travel and subsistence expenses and dependency
allowances), adjusted periodically to reflect increases in the
cost of living, for the recipients of the awards as the
Secretary may deem necessary. A Ruth L. Kirschstein National
Research Service Award made to an individual for research or
research training at a non-Federal public or nonprofit private
institution shall also provide for payments to be made to the
institution for the cost of support services (including the
cost of faculty salaries, supplies, equipment, general research
support, and related items) provided such individual by such
institution. The amount of any such payments to any institution
shall be determined by the Secretary and shall bear a direct
relationship to the reasonable costs of the institution for
establishing and maintaining the quality of its biomedical and
behavioral research and training programs.
(c)(1) Each individual who is awarded a Ruth L. Kirschstein
National Research Service Award for postdoctoral research
training shall, in accordance with paragraph (3), engage in
research training, research, or teaching that is health-related
(or any combination thereof) for the period specified in
paragraph (2). Such period shall be served in accordance with
the usual patterns of scientific employment.
(2)(A) The period referred to in paragraph (1) is 12
months, or one month for each month for which the individual
involved receives a Ruth L. Kirschstein National Research
Service Award for postdoctoral research training, whichever is
less.
(B) With respect to postdoctoral research training, in any
case in which an individual receives a Ruth L. Kirschstein
National Research Service Award for more than 12 months, the
13th month and each subsequent month of performing activities
under the Award shall be considered to be activities engaged in
toward satisfaction of the requirement established in paragraph
(1) regarding a period of service.
(3) The requirement of paragraph (1) shall be complied with
by any individual to whom it applies within such reasonable
period of time, after the completion of such individual's
award, as the Secretary shall by regulation prescribe. The
Secretary shall by regulation prescribe the type of research
and teaching in which an individual may engage to comply with
such requirement and such other requirements respecting
research and teaching as the Secretary considers appropriate.
(4)(A) If any individual to whom the requirement of
paragraph (1) is applicable fails, within the period prescribed
by paragraph (3), to comply with such requirements, the United
States shall be entitled to recover from such individual an
amount determined in accordance with the formula--
t--s
A=f <3-ln (> ------- <3-ln )>
t
----------------------------------------------------------------------------------------------------------------
in which ``A'' is the amount the United States is entitled to
recover; ``f'' is the sum of the total amount paid under one or
more Ruth L. Kirschstein National Research Service Awards to
such individual; ``t'' is the total number of months in such
individual's service obligation; and ``s'' is the number of
months of such obligation served by such individual in
accordance with paragraphs (1) and (2) of this subsection.
(B) Any amount which the United States is entitled to
recover under subparagraph (A) shall, within the three-year
period beginning on the date the United States becomes entitled
to recover such amount, be paid to the United States. Until any
amount due the United States under subparagraph (A) on account
of any Ruth L. Kirschstein National Research Service Award is
paid, there shall accrue to the United States interest on such
amount at a rate fixed by the Secretary of the Treasury after
taking into consideration private consumer rates of interest
prevailing on the date the United States becomes entitled to
such amount.
(5)(A) Any obligation of an individual under paragraph (1)
shall be canceled upon the death of such individual.
(B) The Secretary shall by regulation provide for the
waiver or suspension of any such obligation applicable to any
individual whenever compliance by such individual is impossible
or would involve substantial hardship to such individual or
would be against equity and good conscience.
loan repayment program for research with respect to acquired immune
deficiency syndrome
Sec. 487A. [288-1] (a) In General.--The Secretary shall
carry out a program of entering into agreements with
appropriately qualified health professionals under which such
health professionals agree to conduct, as employees of the
National Institutes of Health, research with respect to
acquired immune deficiency syndrome in consideration of the
Federal Government agreeing to repay, for each year of such
service, not more than $35,000 of the principal and interest of
the educational loans of such health professionals.
(b) Applicability of Certain Provisions.--With respect to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III, the
provisions of such subpart shall, except as inconsistent with
subsection (a) of this section, apply to the program
established in such subsection (a) in the same manner and to
the same extent as such provisions apply to the National Health
Service Corps Loan Repayment Program established in such
subpart.
loan repayment program for research with respect to contraception and
infertility
Sec. 487B. [288-2] (a) The Secretary, in consultation with
the Director of the Eunice Kennedy Shriver National Institute
of Child Health and Human Development, shall establish a
program of entering into contracts with qualified health
professionals (including graduate students) under which such
health professionals agree to conduct research with respect to
contraception, or with respect to infertility, in consideration
of the Federal Government agreeing to repay, for each year of
such service, not more than $35,000 of the principal and
interest of the educational loans of such health professionals.
(b) The provisions of sections 338B, 338C, and 338E shall,
except as inconsistent with subsection (a) of this section,
apply to the program established in subsection (a) to the same
extent and in the same manner as such provisions apply to the
National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III.
(c) Amounts available for carrying out this section shall
remain available until the expiration of the second fiscal year
beginning after the fiscal year for which the amounts were made
available.
loan repayment program for research generally
Sec. 487C. [288-3] (a) In General.--
(1) Authority for program.--Subject to paragraph
(2), the Secretary shall carry out a program of
entering into contracts with appropriately qualified
health professionals under which such health
professionals agree to conduct research, as employees
of the National Institutes of Health, in consideration
of the Federal Government agreeing to repay, for each
year of such service, not more than $35,000 of the
principal and interest of the educational loans of such
health professionals.
(2) Limitation.--The Secretary may not enter into
an agreement with a health professional pursuant to
paragraph (1) unless such professional--
(A) has a substantial amount of educational
loans relative to income; and
(B) agrees to serve as an employee of the
National Institutes of Health for purposes of
paragraph (1) for a period of not less than 3
years.
(b) Applicability of Certain Provisions.--With respect to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III, the
provisions of such subpart shall, except as inconsistent with
subsection (a) of this section, apply to the program
established in such subsection (a) in the same manner and to
the same extent as such provisions apply to the National Health
Service Corps Loan Repayment Program established in such
subpart.
h3 deg.undergraduate scholarship program regarding
professions needed by national research institutes
Sec. 487D. [288-4] (a) Establishment of Program.--
(1) In general.--Subject to section 487(a)(1)(C),
the Secretary, acting through the Director of NIH, may
carry out a program of entering into contracts with
individuals described in paragraph (2) under which--
(A) the Director of NIH agrees to provide
to the individuals scholarships for pursuing,
as undergraduates at accredited institutions of
higher education, academic programs appropriate
for careers in professions needed by the
National Institutes of Health; and
(B) the individuals agree to serve as
employees of the National Institutes of Health,
for the period described in subsection (c), in
positions that are needed by the National
Institutes of Health and for which the
individuals are qualified.
(2) Individuals from disadvantaged backgrounds.--
The individuals referred to in paragraph (1) are
individuals who--
(A) are enrolled or accepted for enrollment
as full-time undergraduates at accredited
institutions of higher education; and
(B) are from disadvantaged backgrounds.
(b) Facilitation of Interest of Students in Careers at
National Institutes of Health.--In providing employment to
individuals pursuant to contracts under subsection (a)(1), the
Director of NIH shall carry out activities to facilitate the
interest of the individuals in pursuing careers as employees of
the National Institutes of Health.
(c) Period of Obligated Service.--
(1) Duration of service.--For purposes of
subparagraph (B) of subsection (a)(1), the period of
service for which an individual is obligated to serve
as an employee of the National Institutes of Health is,
subject to paragraph (2)(A), 12 months for each
academic year for which the scholarship under such
subsection is provided.
(2) Schedule for service.--
(A) Subject to subparagraph (B), the
Director of NIH may not provide a scholarship
under subsection (a) unless the individual
applying for the scholarship agrees that--
(i) the individual will serve as an
employee of the National Institutes of
Health full-time for not less than 10
consecutive weeks of each year during
which the individual is attending the
educational institution involved and
receiving such a scholarship;
(ii) the period of service as such
an employee that the individual is
obligated to provide under clause (i)
is in addition to the period of service
as such an employee that the individual
is obligated to provide under
subsection (a)(1)(B); and
(iii) not later than 60 days after
obtaining the educational degree
involved, the individual will begin
serving full-time as such an employee
in satisfaction of the period of
service that the individual is
obligated to provide under subsection
(a)(1)(B).
(B) The Director of NIH may defer the
obligation of an individual to provide a period
of service under subsection (a)(1)(B), if the
Director determines that such a deferral is
appropriate.
(3) Applicability of certain provisions relating to
appointment and compensation.--For any period in which
an individual provides service as an employee of the
National Institutes of Health in satisfaction of the
obligation of the individual under subsection (a)(1)(B)
or paragraph (2)(A)(i), the individual may be appointed
as such an employee without regard to the provisions of
title 5, United States Code, relating to appointment
and compensation.
(d) Provisions Regarding Scholarship.--
(1) Approval of academic program.--The Director of
NIH may not provide a scholarship under subsection (a)
for an academic year unless--
(A) the individual applying for the
scholarship has submitted to the Director a
proposed academic program for the year and the
Director has approved the program; and
(B) the individual agrees that the program
will not be altered without the approval of the
Director.
(2) Academic standing.--The Director of NIH may not
provide a scholarship under subsection (a) for an
academic year unless the individual applying for the
scholarship agrees to maintain an acceptable level of
academic standing, as determined by the educational
institution involved in accordance with regulations
issued by the Secretary.
(3) Limitation on amount.--The Director of NIH may
not provide a scholarship under subsection (a) for an
academic year in an amount exceeding $20,000.
(4) Authorized uses.--A scholarship provided under
subsection (a) may be expended only for tuition
expenses, other reasonable educational expenses, and
reasonable living expenses incurred in attending the
school involved.
(5) Contract regarding direct payments to
institution.--In the case of an institution of higher
education with respect to which a scholarship under
subsection (a) is provided, the Director of NIH may
enter into a contract with the institution under which
the amounts provided in the scholarship for tuition and
other educational expenses are paid directly to the
institution.
(e) Penalties for Breach of Scholarship Contract.--The
provisions of section 338E shall apply to the program
established in subsection (a) to the same extent and in the
same manner as such provisions apply to the National Health
Service Corps Loan Repayment Program established in section
338B.
(f) Requirement of Application.--The Director of NIH may
not provide a scholarship under subsection (a) unless an
application for the scholarship is submitted to the Director
and the application is in such form, is made in such manner,
and contains such agreements, assurances, and information as
the Director determines to be necessary to carry out this
section.
(g) Availability of Authorization of Appropriations.--
Amounts appropriated for a fiscal year for scholarships under
this section shall remain available until the expiration of the
second fiscal year beginning after the fiscal year for which
the amounts were appropriated.
h3 deg.loan repayment program regarding clinical researchers
from disadvantaged backgrounds
Sec. 487E. [288-5] (a) Implementation of Program.--
(1) In general.--Subject to section 487(a)(1)(C),
the Secretary, acting through the Director of NIH may,
subject to paragraph (2), carry out a program of
entering into contracts with appropriately qualified
health professionals who are from disadvantaged
backgrounds under which such health professionals agree
to conduct clinical research in consideration of the
Federal Government agreeing to pay, for each year of
such service, not more than $35,000 of the principal
and interest of the educational loans of the health
professionals.
(2) Limitation.--The Director of NIH may not enter
into a contract with a health professional pursuant to
paragraph (1) unless such professional has a
substantial amount of education loans relative to
income.
(3) Applicability of certain provisions regarding
obligated service.--Except to the extent inconsistent
with this section, the provisions of sections 338B,
338C \1\ and 338E shall apply to the program
established in paragraph (1) to the same extent and in
the same manner as such provisions apply to the
National Health Service Corps Loan Repayment Program
established in section 338B.
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\1\ So in law. There is no comma after ``338C''.
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(b) Availability of Authorization of Appropriations.--
Amounts appropriated for a fiscal year for contracts under
subsection (a) shall remain available until the expiration of
the second fiscal year beginning after the fiscal year for
which the amounts were appropriated.
SEC. 487F. [288-5A] LOAN REPAYMENT PROGRAM REGARDING CLINICAL
RESEARCHERS.
(a) In General.--The Secretary, acting through the Director
of the National Institutes of Health, shall establish a program
to enter into contracts with qualified health professionals
under which such health professionals agree to conduct clinical
research, in consideration of the Federal Government agreeing
to repay, for each year of service conducting such research,
not more than $35,000 of the principal and interest of the
educational loans of such health professionals.
(b) Application of Provisions.--The provisions of sections
338B, 338C, and 338E shall, except as inconsistent with
subsection (a) of this section, apply to the program
established under subsection (a) to the same extent and in the
same manner as such provisions apply to the National Health
Service Corps Loan Repayment Program established in subpart III
of part D of title III.
pediatric research loan repayment program
Sec. 487F. \2\ [288-6] (a) In General.--The Secretary, in
consultation with the Director of NIH, may establish a
pediatric research loan repayment program. Through such
program--
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\2\ So in law. There are two sections 487F. Section 1002(b) of
Public Law 106-310 (114 Stat. 1129) inserted section 487F above.
Subsequently, section 205 of Public Law 106-505 (114 Stat. 2329), which
relates to a loan repayment program regarding clinical researchers,
inserted a section 487F after section 487E.
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(1) the Secretary shall enter into contracts with
qualified health professionals under which such
professionals will agree to conduct pediatric research,
including pediatric pharmacological research, in
consideration of the Federal Government agreeing to
repay, for each year of such service, not more than
$35,000 of the principal and interest of the
educational loans of such professionals; and
(2) the Secretary shall, for the purpose of
providing reimbursements for tax liability resulting
from payments made under paragraph (1) on behalf of an
individual, make payments, in addition to payments
under such paragraph, to the individual in an amount
equal to 39 percent of the total amount of loan
repayments made for the taxable year involved.
(b) Application of Other Provisions.--The provisions of
sections 338B, 338C, and 338E shall, except as inconsistent
with paragraph (1), apply to the program established under such
paragraph to the same extent and in the same manner as such
provisions apply to the National Health Service Corps Loan
Repayment Program established under subpart III of part D of
title III.
(c) Funding.--
(1) In general.--For the purpose of carrying out
this section with respect to a national research
institute the Secretary may reserve, from amounts
appropriated for such institute for the fiscal year
involved, such amounts as the Secretary determines to
be appropriate.
(2) Availability of funds.--Amounts made available
to carry out this section shall remain available until
the expiration of the second fiscal year beginning
after the fiscal year for which such amounts were made
available.
visiting scientist awards
Sec. 488. [288a] (a) The Secretary may make awards
(hereafter in this section referred to as ``Visiting Scientist
Awards'') to outstanding scientists who agree to serve as
visiting scientists at institutions of postsecondary education
which have significant enrollments of disadvantaged students.
Visiting Scientist Awards shall be made by the Secretary to
enable the faculty and students of such institutions to draw
upon the special talents of scientists from other institutions
for the purpose of receiving guidance, advice, and instruction
with regard to research, teaching, and curriculum development
in the biomedical and behavioral sciences and such other
aspects of these sciences as the Secretary shall deem
appropriate.
(b) The amount of each Visiting Scientist Award shall
include such sum as shall be commensurate with the salary or
remuneration which the individual receiving the award would
have been entitled to receive from the institution with which
the individual has, or had, a permanent or immediately prior
affiliation. Eligibility for and terms of Visiting Scientist
Awards shall be determined in accordance with regulations the
Secretary shall prescribe.
studies respecting biomedical and behavioral research personnel
Sec. 489. [288b] (a) The Secretary shall, in accordance
with subsection (b), arrange for the conduct of a continuing
study to--
(1) establish (A) the Nation's overall need for
biomedical and behavioral research personnel, (B) the
subject areas in which such personnel are needed and
the number of such personnel needed in each such area,
and (C) the kinds and extent of training which should
be provided such personnel;
(2) assess (A) current training programs available
for the training of biomedical and behavioral research
personnel which are conducted under this Act, at or
through national research institutes under the National
Institutes of Health, and (B) other current training
programs available for the training of such personnel;
(3) identify the kinds of research positions
available to and held by individuals completing such
programs;
(4) determine, to the extent feasible, whether the
programs referred to in clause (B) of paragraph (2)
would be adequate to meet the needs established under
paragraph (1) if the programs referred to in clause (A)
of paragraph (2) were terminated; and
(5) determine what modifications in the programs
referred to in paragraph (2) are required to meet the
needs established under paragraph (1).
(b)(1) The Secretary shall request the National Academy of
Sciences to conduct the study required by subsection (a) under
an arrangement under which the actual expenses incurred by such
Academy in conducting such study will be paid by the Secretary.
If the National Academy of Sciences is willing to do so, the
Secretary shall enter into such an arrangement with such
Academy for the conduct of such study.
(2) If the National Academy of Sciences is unwilling to
conduct such study under such an arrangement, then the
Secretary shall enter into a similar arrangement with other
appropriate nonprofit private groups or associations under
which such groups or associations will conduct such study and
prepare and submit the reports thereon as provided in
subsection (c).
(3) The National Academy of Sciences or other group or
association conducting the study required by subsection (a)
shall conduct such study in consultation with the Director of
NIH.
(c) A report on the results of the study required under
subsection (a) shall be submitted by the Secretary to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate at least once every four years.
Part H--General Provisions
institutional review boards; ethics guidance program
Sec. 491. [289] (a) The Secretary shall by regulation
require that each entity which applies for a grant, contract,
or cooperative agreement under this Act for any project or
program which involves the conduct of biomedical or behavioral
research involving human subjects submit in or with its
application for such grant, contract, or cooperative agreement
assurances satisfactory to the Secretary that it has
established (in accordance with regulations which the Secretary
shall prescribe) a board (to be known as an ``Institutional
Review Board'') to review biomedical and behavioral research
involving human subjects conducted at or supported by such
entity in order to protect the rights of the human subjects of
such research.
(b)(1) The Secretary shall establish a program within the
Department of Health and Human Services under which requests
for clarification and guidance with respect to ethical issues
raised in connection with biomedical or behavioral research
involving human subjects are responded to promptly and
appropriately.
(2) The Secretary shall establish a process for the prompt
and appropriate response to information provided to the
Director of NIH respecting incidences of violations of the
rights of human subjects of research for which funds have been
made available under this Act. The process shall include
procedures for the receiving of reports of such information
from recipients of funds under this Act and taking appropriate
action with respect to such violations.
peer review requirements
Sec. 492. [289a] (a)(1) The Secretary, acting through the
Director of NIH, shall by regulation require appropriate
technical and scientific peer review of--
(A) applications made for grants and cooperative
agreements under this Act for biomedical and behavioral
research; and
(B) applications made for biomedical and behavioral
research and development contracts to be administered
through the National Institutes of Health.
(2) Regulations promulgated under paragraph (1) shall
require that the review of applications made for grants,
contracts, and cooperative agreements required by the
regulations be conducted--
(A) to the extent practical, in a manner consistent
with the system for technical and scientific peer
review applicable on the date of the date of enactment
of the Health Research Extension Act of 1985 to grants
under this Act for biomedical and behavioral research,
and
(B) to the extent practical, by technical and
scientific peer review groups performing such review on
or before such date,
and shall authorize such review to be conducted by groups
appointed under sections 402(b)(16) and 405(c)(3).
(b) The Director of NIH shall establish procedures for
periodic technical and scientific peer review of research at
the National Institutes of Health. Such procedures shall
require that--
(1) the reviewing entity be provided a written
description of the research to be reviewed, and
(2) the reviewing entity provide the advisory
council of the national research institute involved
with such description and the results of the review by
the entity,
and shall authorize such review to be conducted by groups
appointed under sections 402(b)(6) and 405(c)(3).
(c)(1) In technical and scientific peer review under this
section of proposals for clinical research, the consideration
of any such proposal (including the initial consideration)
shall, except as provided in paragraph (2), include an
evaluation of the technical and scientific merit of the
proposal regarding compliance with section 492B.
(2) Paragraph (1) shall not apply to any proposal for
clinical research that, pursuant to subsection (b) of section
492B, is not subject to the requirement of subsection (a) of
such section regarding the inclusion of women and members of
minority groups as subjects in clinical research.
certain provisions regarding review and approval of proposals for
research
Sec. 492A. [289a-1] (a) Review as Precondition to
Research.--
(1) Protection of human research subjects.--
(A) In the case of any application
submitted to the Secretary for financial
assistance to conduct research, the Secretary
may not approve or fund any application that is
subject to review under section 491(a) by an
Institutional Review Board unless the
application has undergone review in accordance
with such section and has been recommended for
approval by a majority of the members of the
Board conducting such review.
(B) In the case of research that is subject
to review under procedures established by the
Secretary for the protection of human subjects
in clinical research conducted by the National
Institutes of Health, the Secretary may not
authorize the conduct of the research unless
the research has, pursuant to such procedures,
been recommended for approval.
(2) Peer review.--In the case of any proposal for
the National Institutes of Health to conduct or support
research, the Secretary may not approve or fund any
proposal that is subject to technical and scientific
peer review under section 492 unless the proposal has
undergone such review in accordance with such section
and has been recommended for approval by a majority of
the members of the entity conducting such review, and
unless a majority of the voting members of the
appropriate advisory council under section 406, or as
applicable, of the advisory council under section
402(k), has recommended the proposal for approval.
(b) Ethical Review of Research.--
(1) Procedures regarding withholding of funds.--If
research has been recommended for approval for purposes
of subsection (a), the Secretary may not withhold funds
for the research because of ethical considerations
unless--
(A) the Secretary convenes an advisory
board in accordance with paragraph (5) to study
such considerations; and
(B)(i) the majority of the advisory board
recommends that, because of such
considerations, the Secretary withhold funds
for the research; or
(ii) the majority of such board recommends
that the Secretary not withhold funds for the
research because of such considerations, but
the Secretary finds, on the basis of the report
submitted under paragraph (5)(B)(ii), that the
recommendation is arbitrary and capricious.
(2) Rules of construction.--Paragraph (1) may not
be construed as prohibiting the Secretary from
withholding funds for research on the basis of--
(A) the inadequacy of the qualifications of
the entities that would be involved with the
conduct of the research (including the entity
that would directly receive the funds from the
Secretary), subject to the condition that, with
respect to the process of review through which
the research was recommended for approval for
purposes of subsection (a), all findings
regarding such qualifications made in such
process are conclusive; or
(B) the priorities established by the
Secretary for the allocation of funds among
projects of research that have been so
recommended.
(3) Applicability.--The limitation established in
paragraph (1) regarding the authority to withhold funds
because of ethical considerations shall apply without
regard to whether the withholding of funds on such
basis is characterized as a disapproval, a moratorium,
a prohibition, or other characterization.
(4) Preliminary matters regarding use of
procedures.--
(A) If the Secretary makes a determination
that an advisory board should be convened for
purposes of paragraph (1), the Secretary shall,
through a statement published in the Federal
Register, announce the intention of the
Secretary to convene such a board.
(B) A statement issued under subparagraph
(A) shall include a request that interested
individuals submit to the Secretary
recommendations specifying the particular
individuals who should be appointed to the
advisory board involved. The Secretary shall
consider such recommendations in making
appointments to the board.
(C) The Secretary may not make appointments
to an advisory board under paragraph (1) until
the expiration of the 30-day period beginning
on the date on which the statement required in
subparagraph (A) is made with respect to the
board.
(5) Ethics advisory boards.--
(A) Any advisory board convened for
purposes of paragraph (1) shall be known as an
ethics advisory board (in this paragraph
referred to as an ``ethics board'').
(B)(i) An ethics board shall advise,
consult with, and make recommendations to the
Secretary regarding the ethics of the project
of biomedical or behavioral research with
respect to which the board has been convened.
(ii) Not later than 180 days after the date
on which the statement required in paragraph
(4)(A) is made with respect to an ethics board,
the board shall submit to the Secretary, and to
the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate, a
report describing the findings of the board
regarding the project of research involved and
making a recommendation under clause (i) of
whether the Secretary should or should not
withhold funds for the project. The report
shall include the information considered in
making the findings.
(C) An ethics board shall be composed of no
fewer than 14, and no more than 20, individuals
who are not officers or employees of the United
States. The Secretary shall make appointments
to the board from among individuals with
special qualifications and competence to
provide advice and recommendations regarding
ethical matters in biomedical and behavioral
research. Of the members of the board--
(i) no fewer than 1 shall be an
attorney;
(ii) no fewer than 1 shall be an
ethicist;
(iii) no fewer than 1 shall be a
practicing physician;
(iv) no fewer than 1 shall be a
theologian; and
(v) no fewer than one-third, and no
more than one-half, shall be scientists
with substantial accomplishments in
biomedical or behavioral research.
(D) The term of service as a member of an
ethics board shall be for the life of the
board. If such a member does not serve the full
term of such service, the individual appointed
to fill the resulting vacancy shall be
appointed for the remainder of the term of the
predecessor of the individual.
(E) A member of an ethics board shall be
subject to removal from the board by the
Secretary for neglect of duty or malfeasance or
for other good cause shown.
(F) The Secretary shall designate an
individual from among the members of an ethics
board to serve as the chair of the board.
(G) In carrying out subparagraph (B)(i)
with respect to a project of research, an
ethics board shall conduct inquiries and hold
public hearings.
(H) In carrying out subparagraph (B)(i)
with respect to a project of research, an
ethics board shall have access to all relevant
information possessed by the Department of
Health and Human Services, or available to the
Secretary from other agencies.
(I) Members of an ethics board shall
receive compensation for each day engaged in
carrying out the duties of the board, including
time engaged in traveling for purposes of such
duties. Such compensation may not be provided
in an amount in excess of the maximum rate of
basic pay payable for GS-18 of the General
Schedule.
(J) The Secretary, acting through the
Director of the National Institutes of Health,
shall provide to each ethics board reasonable
staff and assistance to carry out the duties of
the board.
(K) An ethics board shall terminate 30 days
after the date on which the report required in
subparagraph (B)(ii) is submitted to the
Secretary and the congressional committees
specified in such subparagraph.
(6) Definition.--For purposes of this subsection,
the term ``ethical considerations'' means
considerations as to whether the nature of the research
involved is such that it is unethical to conduct or
support the research.
inclusion of women and minorities in clinical research
Sec. 492B. [289a-2] (a) Requirement of Inclusion.--
(1) In general.--In conducting or supporting
clinical research for purposes of this title, the
Director of NIH shall, subject to subsection (b),
ensure that--
(A) women are included as subjects in each
project of such research; and
(B) members of minority groups are included
as subjects in such research.
(2) Outreach regarding participation as subjects.--
The Director of NIH, in consultation with the Director
of the Office of Research on Women's Health and the
Director of the Office of Research on Minority Health,
shall conduct or support outreach programs for the
recruitment of women and members of minority groups as
subjects in projects of clinical research.
(b) Inapplicability of Requirement.--The requirement
established in subsection (a) regarding women and members of
minority groups shall not apply to a project of clinical
research if the inclusion, as subjects in the project, of women
and members of minority groups, respectively--
(1) is inappropriate with respect to the health of
the subjects;
(2) is inappropriate with respect to the purpose of
the research; or
(3) is inappropriate under such other circumstances
as the Director of NIH may designate.
(c) Design of Clinical Trials.--In the case of any clinical
trial in which women or members of minority groups will under
subsection (a) be included as subjects, the Director of NIH
shall ensure that the trial is designed and carried out in a
manner sufficient to provide for a valid analysis of whether
the variables being studied in the trial affect women or
members of minority groups, as the case may be, differently
than other subjects in the trial.
(d) Guidelines.--
(1) In general.--Subject to paragraph (2), the
Director of NIH, in consultation with the Director of
the Office of Research on Women's Health and the
Director of the Office of Research on Minority Health,
shall establish guidelines regarding the requirements
of this section. The guidelines shall include
guidelines regarding--
(A) the circumstances under which the
inclusion of women and minorities as subjects
in projects of clinical research is
inappropriate for purposes of subsection (b);
(B) the manner in which clinical trials are
required to be designed and carried out for
purposes of subsection (c); and
(C) the operation of outreach programs
under subsection (a).
(2) Certain provisions.--With respect to the
circumstances under which the inclusion of women or
members of minority groups (as the case may be) as
subjects in a project of clinical research is
inappropriate for purposes of subsection (b), the
following applies to guidelines under paragraph (1):
(A)(i) In the case of a clinical trial, the
guidelines shall provide that the costs of such
inclusion in the trial is not a permissible
consideration in determining whether such
inclusion is inappropriate.
(ii) In the case of other projects of
clinical research, the guidelines shall provide
that the costs of such inclusion in the project
is not a permissible consideration in
determining whether such inclusion is
inappropriate unless the data regarding women
or members of minority groups, respectively,
that would be obtained in such project (in the
event that such inclusion were required) have
been or are being obtained through other means
that provide data of comparable quality.
(B) In the case of a clinical trial, the
guidelines may provide that such inclusion in
the trial is not required if there is
substantial scientific data demonstrating that
there is no significant difference between--
(i) the effects that the variables
to be studied in the trial have on
women or members of minority groups,
respectively; and
(ii) the effects that the variables
have on the individuals who would serve
as subjects in the trial in the event
that such inclusion were not required.
(e) Date Certain for Guidelines; Applicability.--
(1) Date certain.--The guidelines required in
subsection (d) shall be established and published in
the Federal Register not later than 180 days after the
date of the enactment of the National Institutes of
Health Revitalization Act of 1993.
(2) Applicability.--For fiscal year 1995 and
subsequent fiscal years, the Director of NIH may not
approve any proposal of clinical research to be
conducted or supported by any agency of the National
Institutes of Health unless the proposal specifies the
manner in which the research will comply with this
section.
(f) Reports by Advisory Councils.--The advisory council of
each national research institute shall prepare biennial reports
describing the manner in which the institute has complied with
this section. Each such report shall be submitted to the
Director of the institute involved for inclusion in the
biennial report under section 403.
(g) Definitions.--For purposes of this section:
(1) The term ``project of clinical research''
includes a clinical trial.
(2) The term ``minority group'' includes
subpopulations of minority groups. The Director of NIH
shall, through the guidelines established under
subsection (d), define the terms ``minority group'' and
``subpopulation'' for purposes of the preceding
sentence.
office of research integrity
Sec. 493. [289b] (a) In General.--
(1) Establishment of office.--Not later than 90
days after the date of enactment of this section, the
Secretary shall establish an office to be known as the
Office of Research Integrity (referred to in this
section as the ``Office''), which shall be established
as an independent entity in the Department of Health
and Human Services.
(2) Appointment of director.--The Office shall be
headed by a Director, who shall be appointed by the
Secretary, be experienced and specially trained in the
conduct of research, and have experience in the conduct
of investigations of research misconduct. The Secretary
shall carry out this section acting through the
Director of the Office. The Director shall report to
the Secretary.
(3) Definitions.--
(A) The Secretary shall by regulation
establish a definition for the term ``research
misconduct'' for purposes of this section.
(B) For purposes of this section, the term
``financial assistance'' means a grant,
contract, or cooperative agreement.
(b) Existence of Administrative Processes as Condition of
Funding for Research.--The Secretary shall by regulation
require that each entity that applies for financial assistance
under this Act for any project or program that involves the
conduct of biomedical or behavioral research submit in or with
its application for such assistance--
(1) assurances satisfactory to the Secretary that
such entity has established and has in effect (in
accordance with regulations which the Secretary shall
prescribe) an administrative process to review reports
of research misconduct in connection with biomedical
and behavioral research conducted at or sponsored by
such entity;
(2) an agreement that the entity will report to the
Director any investigation of alleged research
misconduct in connection with projects for which funds
have been made available under this Act that appears
substantial; and
(3) an agreement that the entity will comply with
regulations issued under this section.
(c) Process for Response of Director.--The Secretary shall
by regulation establish a process to be followed by the
Director for the prompt and appropriate--
(1) response to information provided to the
Director respecting research misconduct in connection
with projects for which funds have been made available
under this Act;
(2) receipt of reports by the Director of such
information from recipients of funds under this Act;
(3) conduct of investigations, when appropriate;
and
(4) taking of other actions, including appropriate
remedies, with respect to such misconduct.
(d) Monitoring by Director.--The Secretary shall by
regulation establish procedures for the Director to monitor
administrative processes and investigations that have been
established or carried out under this section.
(e) Protection of Whistleblowers.--
(1) In general.--In the case of any entity required
to establish administrative processes under subsection
(b), the Secretary shall by regulation establish
standards for preventing, and for responding to the
occurrence of retaliation by such entity, its officials
or agents, against an employee in the terms and
conditions of employment in response to the employee
having in good faith--
(A) made an allegation that the entity, its
officials or agents, has engaged in or failed
to adequately respond to an allegation of
research misconduct; or
(B) cooperated with an investigation of
such an allegation.
(2) Monitoring by secretary.--The Secretary shall
by regulation establish procedures for the Director to
monitor the implementation of the standards established
by an entity under paragraph (1) for the purpose of
determining whether the procedures have been
established, and are being utilized, in accordance with
the standards established under such paragraph.
(3) Noncompliance.--The Secretary shall by
regulation establish remedies for noncompliance by an
entity, its officials or agents, which has engaged in
retaliation in violation of the standards established
under paragraph (1). Such remedies may include
termination of funding provided by the Secretary for
such project or recovery of funding being provided by
the Secretary for such project, or other actions as
appropriate.
protection against financial conflicts of interest in certain projects
of research
Sec. 493A. [289b-1] (a) Issuance of Regulations.--The
Secretary shall by regulation define the specific circumstances
that constitute the existence of a financial interest in a
project on the part of an entity or individual that will, or
may be reasonably expected to, create a bias in favor of
obtaining results in such project that are consistent with such
financial interest. Such definition shall apply uniformly to
each entity or individual conducting a research project under
this Act. In the case of any entity or individual receiving
assistance from the Secretary for a project of research
described in subsection (b), the Secretary shall by regulation
establish standards for responding to, including managing,
reducing, or eliminating, the existence of such a financial
interest. The entity may adopt individualized procedures for
implementing the standards.
(b) Relevant Projects.--A project of research referred to
in subsection (a) is a project of clinical research whose
purpose is to evaluate the safety or effectiveness of a drug,
medical device, or treatment and for which such entity is
receiving assistance from the Secretary.
(c) Identifying and Reporting to Secretary.--The Secretary
shall by regulation require that each entity described in
subsection (a) that applies for assistance under this Act for
any project described in subsection (b) submit in or with its
application for such assistance--
(1) assurances satisfactory to the Secretary that
such entity has established and has in effect an
administrative process under subsection (a) to identify
financial interests (as defined under subsection (a))
that exist regarding the project; and
(2) an agreement that the entity will report to the
Secretary such interests identified by the entity and
how any such interests identified by the entity will be
managed or eliminated in order that the project in
question will be protected from bias that may stem from
such interests; and
(3) an agreement that the entity will comply with
regulations issued under this section.
(d) Monitoring of Process.--The Secretary shall monitor the
establishment and conduct of the administrative process
established by an entity pursuant to subsection (a).
(e) Response.--In any case in which the Secretary
determines that an entity has failed to comply with subsection
(c) regarding a project of research described in subsection
(b), the Secretary--
(1) shall require that, as a condition of receiving
assistance, the entity disclose the existence of a
financial interest (as defined under subsection (a)) in
each public presentation of the results of such
project; and
(2) may take such other actions as the Secretary
determines to be appropriate.
(f) Definitions.--For purposes of this section:
(1) The term ``financial interest'' includes the
receipt of consulting fees or honoraria and the
ownership of stock or equity.
(2) The term ``assistance'', with respect to
conducting a project of research, means a grant,
contract, or cooperative agreement.
research on public health emergencies
Sec. 494. [289c] If the Secretary determines, after
consultation with the Director of NIH, the Commissioner of the
Food and Drug Administration, or the Director of the Centers
for Disease Control and Prevention, that a disease or disorder
constitutes a public health emergency, the Secretary, acting
through the Director of NIH--
(1) shall expedite the review by advisory councils
under section 406 and by peer review groups under
section 492 of applications for grants for research on
such disease or disorder or proposals for contracts for
such research;
(2) shall exercise the authority in section 3709 of
the Revised Statutes (41 U.S.C. 5) respecting public
exigencies to waive the advertising requirements of
such section in the case of proposals for contracts for
such research;
(3) may provide administrative supplemental
increases in existing grants and contracts to support
new research relevant to such disease or disorder; and
(4) shall disseminate, to health professionals and
the public, information on the cause, prevention, and
treatment of such disease or disorder that has been
developed in research assisted under this section.
The amount of an increase in a grant or contract provided under
paragraph (3) may not exceed one-half the original amount of
the grant or contract.
collaborative use of certain health services research funds
Sec. 494A. [289c-1] The Secretary shall ensure that amounts
made available under subparts 14, 15 and 16 of part C for
health services research relating to alcohol abuse and
alcoholism, drug abuse and mental health be used
collaboratively, as appropriate, and in consultation with the
Agency for Health Care Policy Research.
animals in research
Sec. 495. [289d] (a) The Secretary, acting through the
Director of NIH, shall establish guidelines for the following:
(1) The proper care of animals to be used in
biomedical and behavioral research.
(2) The proper treatment of animals while being
used in such research. Guidelines under this paragraph
shall require--
(A) the appropriate use of tranquilizers,
analgesics, anesthetics, paralytics, and
euthanasia for animals in such research; and
(B) appropriate pre-surgical and post-
surgical veterinary medical and nursing care
for animals in such research.
Such guidelines shall not be construed to prescribe
methods of research.
(3) The organization and operation of animal care
committees in accordance with subsection (b).
(b)(1) Guidelines of the Secretary under subsection (a)(3)
shall require animal care committees at each entity which
conducts biomedical and behavioral research with funds provided
under this Act (including the National Institutes of Health and
the national research institutes) to assure compliance with the
guidelines established under subsection (a).
(2) Each animal care committee shall be appointed by the
chief executive officer of the entity for which the committee
is established, shall be composed of not fewer than three
members, and shall include at least one individual who has no
association with such entity and at least one doctor of
veterinary medicine.
(3) Each animal care committee of a research entity shall--
(A) review the care and treatment of animals in all
animal study areas and facilities of the research
entity at least semi-annually to evaluate compliance
with applicable guidelines established under subsection
(a) for appropriate animal care and treatment;
(B) keep appropriate records of reviews conducted
under subparagraph (A); and
(C) for each review conducted under subparagraph
(A), file with the Director of NIH at least annually
(i) a certification that the review has been conducted,
and (ii) reports of any violations of guidelines
established under subsection (a) or assurances required
under paragraph (1) which were observed in such review
and which have continued after notice by the committee
to the research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority
views filed by members of the committee.
(c) The Director of NIH shall require each applicant for a
grant, contract, or cooperative agreement involving research on
animals which is administered by the National Institutes of
Health or any national research institute to include in its
application or contract proposal, submitted after the
expiration of the twelve-month period beginning on the date of
enactment of this section--
(1) assurances satisfactory to the Director of NIH
that--
(A) the applicant meets the requirements of
the guidelines established under paragraphs (1)
and (2) of subsection (a) and has an animal
care committee which meets the requirements of
subsection (b); and
(B) scientists, animal technicians, and
other personnel involved with animal care,
treatment, and use by the applicant have
available to them instruction or training in
the humane practice of animal maintenance and
experimentation, and the concept, availability,
and use of research or testing methods that
limit the use of animals or limit animal
distress; and
(2) a statement of the reasons for the use of
animals in the research to be conducted with funds
provided under such grant or contract.
Notwithstanding subsection (a)(2) of section 553 of title 5,
United States Code, regulations under this subsection shall be
promulgated in accordance with the notice and comment
requirements of such section.
(d) If the Director of NIH determines that--
(1) the conditions of animal care, treatment, or
use in an entity which is receiving a grant, contract,
or cooperative agreement involving research on animals
under this title do not meet applicable guidelines
established under subsection (a);
(2) the entity has been notified by the Director of
NIH of such determination and has been given a
reasonable opportunity to take corrective action; and
(3) no action has been taken by the entity to
correct such conditions;
the Director of NIH shall suspend or revoke such grant or
contract under such conditions as the Director determines
appropriate.
(e) No guideline or regulation promulgated under subsection
(a) or (c) may require a research entity to disclose publicly
trade secrets or commercial or financial information which is
privileged or confidential.
use of appropriations under this title
Sec. 496. [289e] (a) Appropriations to carry out the
purposes of this title, unless otherwise expressly provided,
may be expended in the District of Columbia for--
(1) personal services;
(2) stenographic recording and translating
services;
(3) travel expenses (including the expenses of
attendance at meetings when specifically authorized by
the Secretary);
(4) rental;
(5) supplies and equipment;
(6) purchase and exchange of medical books, books
of reference, directories, periodicals, newspapers, and
press clippings;
(7) purchase, operation, and maintenance of
passenger motor vehicles;
(8) printing and binding (in addition to that
otherwise provided by law); and
(9) all other necessary expenses in carrying out
this title.
Such appropriations may be expended by contract if deemed
necessary, without regard to section 3709 of the Revised
Statutes (41 U.S.C. 5).
(b)(1) None of the amounts appropriated under this Act for
the purposes of this title may be obligated for the
construction of facilities (including the acquisition of land)
unless a provision of this title establishes express authority
for such purpose and unless the Act making appropriations under
such provision specifies that the amounts appropriated are
available for such purpose.
(2) Any grants, cooperative agreements, or contracts
authorized in this title for the construction of facilities may
be awarded only on a competitive basis.
gifts
Sec. 497. [289f] The Secretary may, in accordance with
section 231, accept conditional gifts for the National
Institutes of Health or a national research institute or for
the acquisition of grounds or for the erection, equipment, or
maintenance of facilities for the National Institutes of Health
or a national research institute. Donations of $50,000 or over
for the National Institutes of Health or a national research
institute for carrying out the purposes of this title may be
acknowledged by the establishment within the National
Institutes of Health or a national research institute of
suitable memorials to the donors.
fetal research
Sec. 498. [289g] (a) The Secretary may not conduct or
support any research or experimentation, in the United States
or in any other country, on a nonviable living human fetus ex
utero or a living human fetus ex utero for whom viability has
not been ascertained unless the research or experimentation--
may enhance the well-being or meet the health needs
of the fetus or enhance the probability of its survival
to viability; or
(2) will pose no added risk of suffering, injury,
or death to the fetus and the purpose of the research
or experimentation is the development of important
biomedical knowledge which cannot be obtained by other
means.
(b) In administering the regulations for the protection of
human research subjects which--
(1) apply to research conducted or supported by the
Secretary;
(2) involve living human fetuses in utero; and
(3) are published in section 46.208 of part 46 of
title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall
require that the risk standard (published in section 46.102(g)
of such part 46 or any successor to such regulations) be the
same for fetuses which are intended to be aborted and fetuses
which are intended to be carried to term.
research on transplantation of fetal tissue
Sec. 498A. [289g-1] (a) Establishment of Program.--
(1) In general.--The Secretary may conduct or
support research on the transplantation of human fetal
tissue for therapeutic purposes.
(2) Source of tissue.--Human fetal tissue may be
used in research carried out under paragraph (1)
regardless of whether the tissue is obtained pursuant
to a spontaneous or induced abortion or pursuant to a
stillbirth.
(b) Informed Consent of Donor.--
(1) In general.--In research carried out under
subsection (a), human fetal tissue may be used only if
the woman providing the tissue makes a statement, made
in writing and signed by the woman, declaring that--
(A) the woman donates the fetal tissue for
use in research described in subsection (a);
(B) the donation is made without any
restriction regarding the identity of
individuals who may be the recipients of
transplantations of the tissue; and
(C) the woman has not been informed of the
identity of any such individuals.
(2) Additional statement.--In research carried out
under subsection (a), human fetal tissue may be used
only if the attending physician with respect to
obtaining the tissue from the woman involved makes a
statement, made in writing and signed by the physician,
declaring that--
(A) in the case of tissue obtained pursuant
to an induced abortion--
(i) the consent of the woman for
the abortion was obtained prior to
requesting or obtaining consent for a
donation of the tissue for use in such
research;
(ii) no alteration of the timing,
method, or procedures used to terminate
the pregnancy was made solely for the
purposes of obtaining the tissue; and
(iii) the abortion was performed in
accordance with applicable State law;
(B) the tissue has been donated by the
woman in accordance with paragraph (1); and
(C) full disclosure has been provided to
the woman with regard to--
(i) such physician's interest, if
any, in the research to be conducted
with the tissue; and
(ii) any known medical risks to the
woman or risks to her privacy that
might be associated with the donation
of the tissue and that are in addition
to risks of such type that are
associated with the woman's medical
care.
(c) Informed Consent of Researcher and Donee.--In research
carried out under subsection (a), human fetal tissue may be
used only if the individual with the principal responsibility
for conducting the research involved makes a statement, made in
writing and signed by the individual, declaring that the
individual--
(1) is aware that--
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained
pursuant to a spontaneous or induced abortion
or pursuant to a stillbirth; and
(C) the tissue was donated for research
purposes;
(2) has provided such information to other
individuals with responsibilities regarding the
research;
(3) will require, prior to obtaining the consent of
an individual to be a recipient of a transplantation of
the tissue, written acknowledgment of receipt of such
information by such recipient; and
(4) has had no part in any decisions as to the
timing, method, or procedures used to terminate the
pregnancy made solely for the purposes of the research.
(d) Availability of Statements for Audit.--
(1) In general.--In research carried out under
subsection (a), human fetal tissue may be used only if
the head of the agency or other entity conducting the
research involved certifies to the Secretary that the
statements required under subsections (b)(2) and (c)
will be available for audit by the Secretary.
(2) Confidentiality of audit.--Any audit conducted
by the Secretary pursuant to paragraph (1) shall be
conducted in a confidential manner to protect the
privacy rights of the individuals and entities involved
in such research, including such individuals and
entities involved in the donation, transfer, receipt,
or transplantation of human fetal tissue. With respect
to any material or information obtained pursuant to
such audit, the Secretary shall--
(A) use such material or information only
for the purposes of verifying compliance with
the requirements of this section;
(B) not disclose or publish such material
or information, except where required by
Federal law, in which case such material or
information shall be coded in a manner such
that the identities of such individuals and
entities are protected; and
(C) not maintain such material or
information after completion of such audit,
except where necessary for the purposes of such
audit.
(e) Applicability of State and Local Law.--
(1) Research conducted by recipients of
assistance.--The Secretary may not provide support for
research under subsection (a) unless the applicant for
the financial assistance involved agrees to conduct the
research in accordance with applicable State law.
(2) Research conducted by secretary.--The Secretary
may conduct research under subsection (a) only in
accordance with applicable State and local law.
(f) Report.--The Secretary shall annually submit to the
Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report describing the activities
carried out under this section during the preceding fiscal
year, including a description of whether and to what extent
research under subsection (a) has been conducted in accordance
with this section.
(g) Definition.--For purposes of this section, the term
``human fetal tissue'' means tissue or cells obtained from a
dead human embryo or fetus after a spontaneous or induced
abortion, or after a stillbirth.
prohibitions regarding human fetal tissue
Sec. 498B. [289g-2] (a) Purchase of Tissue.--It shall be
unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human fetal tissue for valuable
consideration if the transfer affects interstate commerce.
(b) Solicitation or Acceptance of Tissue as Directed
Donation for Use in Transplantation.--It shall be unlawful for
any person to solicit or knowingly acquire, receive, or accept
a donation of human fetal tissue for the purpose of
transplantation of such tissue into another person if the
donation affects interstate commerce, the tissue will be or is
obtained pursuant to an induced abortion, and--
(1) the donation will be or is made pursuant to a
promise to the donating individual that the donated
tissue will be transplanted into a recipient specified
by such individual;
(2) the donated tissue will be transplanted into a
relative of the donating individual; or
(3) the person who solicits or knowingly acquires,
receives, or accepts the donation has provided valuable
consideration for the costs associated with such
abortion.
(c) Solicitation or Acceptance of Tissue From Fetuses
Gestated for Research Purposes.--It shall be unlawful for any
person or entity involved or engaged in interstate commerce
to--
(1) solicit or knowingly acquire, receive, or
accept a donation of human fetal tissue knowing that a
human pregnancy was deliberately initiated to provide
such tissue; or
(2) knowingly acquire, receive, or accept tissue or
cells obtained from a human embryo or fetus that was
gestated in the uterus of a nonhuman animal.
(d) Criminal Penalties for Violations.--
(1) In general.--Any person who violates subsection
(a), (b), or (c) shall be fined in accordance with
title 18, United States Code, subject to paragraph (2),
or imprisoned for not more than 10 years, or both.
(2) Penalties applicable to persons receiving
consideration.--With respect to the imposition of a
fine under paragraph (1), if the person involved
violates subsection (a) or (b)(3), a fine shall be
imposed in an amount not less than twice the amount of
the valuable consideration received.
(e) Definitions.--For purposes of this section:
(1) The term ``human fetal tissue'' has the meaning
given such term in section 498A(g).
(2) The term ``interstate commerce'' has the
meaning given such term in section 201(b) of the
Federal Food, Drug, and Cosmetic Act.
(3) The term ``valuable consideration'' does not
include reasonable payments associated with the
transportation, implantation, processing, preservation,
quality control, or storage of human fetal tissue.
SEC. 498C. [289G-3] BREAST IMPLANT RESEARCH.
(a) In General.--The Director of NIH may conduct or support
research to examine the long-term health implications of
silicone breast implants, both gel and saline filled. Such
research studies may include the following:
(1) Developing and examining techniques to measure
concentrations of silicone in body fluids and tissues.
(2) Surveillance of recipients of silicone breast
implants, including long-term outcomes and local
complications.
(b) Definition.--For purposes of this section, the term
``breast implant'' means a breast prosthesis that is implanted
to augment or reconstruct the female breast.
SEC. 498D. [289G-4] SUPPORT FOR EMERGENCY MEDICINE RESEARCH.
(a) Emergency Medical Research.--The Secretary shall
support Federal programs administered by the National
Institutes of Health, the Agency for Healthcare Research and
Quality, the Health Resources and Services Administration, the
Centers for Disease Control and Prevention, and other agencies
involved in improving the emergency care system to expand and
accelerate research in emergency medical care systems and
emergency medicine, including--
(1) the basic science of emergency medicine;
(2) the model of service delivery and the
components of such models that contribute to enhanced
patient health outcomes;
(3) the translation of basic scientific research
into improved practice; and
(4) the development of timely and efficient
delivery of health services.
(b) Pediatric Emergency Medical Research.--The Secretary
shall support Federal programs administered by the National
Institutes of Health, the Agency for Healthcare Research and
Quality, the Health Resources and Services Administration, the
Centers for Disease Control and Prevention, and other agencies
to coordinate and expand research in pediatric emergency
medical care systems and pediatric emergency medicine,
including--
(1) an examination of the gaps and opportunities in
pediatric emergency care research and a strategy for
the optimal organization and funding of such research;
(2) the role of pediatric emergency services as an
integrated component of the overall health system;
(3) system-wide pediatric emergency care planning,
preparedness, coordination, and funding;
(4) pediatric training in professional education;
and
(5) research in pediatric emergency care,
specifically on the efficacy, safety, and health
outcomes of medications used for infants, children, and
adolescents in emergency care settings in order to
improve patient safety.
(c) Impact Research.--The Secretary shall support research
to determine the estimated economic impact of, and savings that
result from, the implementation of coordinated emergency care
systems.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2014.
PART I--FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH
SEC. 499. [290B] ESTABLISHMENT AND DUTIES OF FOUNDATION.
(a) In General.--The Secretary shall, acting through the
Director of NIH, establish a nonprofit corporation to be known
as the Foundation for the National Institutes of Health
(hereafter in this section referred to as the ``Foundation'').
The Foundation shall not be an agency or instrumentality of the
United States Government.
(b) Purpose of Foundation.--The purpose of the Foundation
shall be to support the National Institutes of Health in its
mission (including collection of funds for pediatric
pharmacologic research), and to advance collaboration with
biomedical researchers from universities, industry, and
nonprofit organizations.
(c) Certain Activities of Foundation.--
(1) In general.--In carrying out subsection (b),
the Foundation may solicit and accept gifts, grants,
and other donations, establish accounts, and invest and
expend funds in support of the following activities
with respect to the purpose described in such
subsection:
(A) A program to provide and administer
endowed positions that are associated with the
research program of the National Institutes of
Health. Such endowments may be expended for the
compensation of individuals holding the
positions, for staff, equipment, quarters,
travel, and other expenditures that are
appropriate in supporting the endowed
positions.
(B) A program to provide and administer
fellowships and grants to research personnel in
order to work and study in association with the
National Institutes of Health. Such fellowships
and grants may include stipends, travel, health
insurance benefits and other appropriate
expenses. The recipients of fellowships shall
be selected by the donors and the Foundation
upon the recommendation of the National
Institutes of Health employees in the
laboratory where the fellow would serve, and
shall be subject to the agreement of the
Director of the National Institutes of Health
and the Executive Director of the Foundation.
(C) A program to collect funds for
pediatric pharmacologic research and studies
for which the Secretary issues a certification
in the affirmative under section 505A(n)(1)(A)
of the Federal Food, Drug, and Cosmetic Act.
(D) Supplementary programs to provide for--
(i) scientists of other countries
to serve in research capacities in the
United States in association with the
National Institutes of Health or
elsewhere, or opportunities for
employees of the National Institutes of
Health or other public health officials
in the United States to serve in such
capacities in other countries, or both;
(ii) the conduct and support of
studies, projects, and research, which
may include stipends, travel and other
support for personnel in collaboration
with national and international non-
profit and for-profit organizations;
(iii) the conduct and support of
forums, meetings, conferences, courses,
and training workshops that may include
undergraduate, graduate, post-graduate,
and post-doctoral accredited courses
and the maintenance of accreditation of
such courses by the Foundation at the
State and national level for college or
continuing education credits or for
degrees;
(iv) programs to support and
encourage teachers and students of
science at all levels of education and
programs for the general public which
promote the understanding of science;
(v) programs for writing, editing,
printing, publishing, and vending of
books and other materials; and
(vi) the conduct of other
activities to carry out and support the
purpose described in subsection (b).
(E) The Cures Acceleration Network
described in section 402C.
(2) Fees.--The Foundation may assess fees for the
provision of professional, administrative and
management services by the Foundation in amounts
determined reasonable and appropriate by the Executive
Director.
(3) Authority of foundation.--The Foundation shall
be the sole entity responsible for carrying out the
activities described in this subsection.
(d) Board of Directors.--
(1) Composition.--
(A) The Foundation shall have a Board of
Directors (hereafter referred to in this
section as the ``Board''), which shall be
composed of ex officio and appointed members in
accordance with this subsection. All appointed
members of the Board shall be voting members.
(B) The ex officio members of the Board
shall be--
(i) the Chairman and ranking
minority member of the Subcommittee on
Health and the Environment (Committee
on Energy and Commerce) or their
designees, in the case of the House of
Representatives;
(ii) the Chairman and ranking
minority member of the Committee on
Labor and Human Resources or their
designees, in the case of the Senate;
(iii) the Director of the National
Institutes of Health; and
(iv) the Commissioner of Food and
Drugs.
(C) The ex officio members of the Board
under subparagraph (B) shall appoint to the
Board individuals from among a list of
candidates to be provided by the National
Academy of Science. Such appointed members
shall include--
(i) representatives of the general
biomedical field;
(ii) representatives of experts in
pediatric medicine and research;
(iii) representatives of the
general biobehavioral field, which may
include experts in biomedical ethics;
and
(iv) representatives of the general
public, which may include
representatives of affected industries.
(D)(i) Not later than 30 days after the
date of the enactment of the National
Institutes of Health Revitalization Act of
1993, the Director of the National Institutes
of Health shall convene a meeting of the ex
officio members of the Board to--
(I) incorporate the Foundation and
establish the general policies of the
Foundation for carrying out the
purposes of subsection (b), including
the establishment of the bylaws of the
Foundation; and
(II) appoint the members of the
Board in accordance with subparagraph
(C).
(ii) Upon the appointment of the
appointed members of the Board under
clause (i)(II), the terms of service as
members of the Board of the ex officio
members of the Board described in
clauses (i) and (ii) of subparagraph
(B) shall terminate. The ex officio
members of the Board described in
clauses (iii) and (iv) of subparagraph
(B) shall continue to serve as ex
officio members of the Board.
(E) The agreement of not less than three-
fifths of the members of the ex officio members
of the Board shall be required for the
appointment of each member to the initial
Board.
(F) No employee of the National Institutes
of Health shall be appointed as a member of the
Board.
(G) The Board may, through amendments to
the bylaws of the Foundation, provide that the
number of appointed members of the Board shall
be greater than the number specified in
subparagraph (C).
(2) Chair.--
(A) The ex officio members of the Board
under paragraph (1)(B) shall designate an
individual to serve as the initial Chair of the
Board.
(B) Upon the termination of the term of
service of the initial Chair of the Board, the
appointed members of the Board shall elect a
member of the Board to serve as the Chair of
the Board.
(3) Terms and vacancies.--
(A) The term of office of each member of
the Board appointed under paragraph (1)(C)
shall be 5 years, except that the terms of
offices for the initial appointed members of
the Board shall expire as determined by the ex
officio members and the Chair.
(B) Any vacancy in the membership of the
appointed members of the Board shall be filled
in accordance with the bylaws of the Foundation
established in accordance with paragraph (6),
and shall not affect the power of the remaining
appointed members to execute the duties of the
Board.
(C) If a member of the Board does not serve
the full term applicable under subparagraph
(A), the individual appointed to fill the
resulting vacancy shall be appointed for the
remainder of the term of the predecessor of the
individual.
(D) A member of the Board may continue to
serve after the expiration of the term of the
member until a successor is appointed.
(4) Compensation.--Members of the Board may not
receive compensation for service on the Board. Such
members may be reimbursed for travel, subsistence, and
other necessary expenses incurred in carrying out the
duties of the Board, as set forth in the bylaws issued
by the Board.
(5) Meetings and quorum.--A majority of the
appointed members of the Board shall constitute a
quorum for purposes of conducting the business of the
Board.
(6) Certain bylaws.--
(A) In establishing bylaws under this
subsection, the Board shall ensure that the
following are provided for:
(i) Policies for the selection of
the officers, employees, agents, and
contractors of the Foundation.
(ii) Policies, including ethical
standards, for the acceptance,
solicitation, and disposition of
donations and grants to the Foundation
and for the disposition of the assets
of the Foundation. Policies with
respect to ethical standards shall
ensure that officers, employees and
agents of the Foundation (including
members of the Board) avoid
encumbrances that would result in a
conflict of interest, including a
financial conflict of interest or a
divided allegiance. Such policies shall
include requirements for the provision
of information concerning any ownership
or controlling interest in entities
related to the activities of the
Foundation by such officers, employees
and agents and their spouses and
relatives.
(iii) Policies for the conduct of
the general operations of the
Foundation.
(iv) Policies for writing, editing,
printing, publishing, and vending of
books and other materials.
(B) In establishing bylaws under this
subsection, the Board shall ensure that such
bylaws (and activities carried out under the
bylaws) do not--
(i) reflect unfavorably upon the
ability of the Foundation or the
National Institutes of Health to carry
out its responsibilities or official
duties in a fair and objective manner;
or
(ii) compromise, or appear to
compromise, the integrity of any
governmental agency or program, or any
officer or employee involved in such
program.
(e) Incorporation.--The initial members of the Board shall
serve as incorporators and shall take whatever actions
necessary to incorporate the Foundation.
(f) Nonprofit status.--The Foundation shall be considered
to be a corporation under section 501(c) of the Internal
Revenue Code of 1986, and shall be subject to the provisions of
such section.
(g) Executive Director.--
(1) In general.--The Foundation shall have an
Executive Director who shall be appointed by the Board
and shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-
day operations of the Foundation and shall have such
specific duties and responsibilities as the Board shall
prescribe.
(2) Compensation.--The rate of compensation of the
Executive Director shall be fixed by the Board.
(h) Powers.--In carrying out subsection (b), the Foundation
may--
(1) operate under the direction of its Board;
(2) adopt, alter, and use a corporate seal, which
shall be judicially noticed;
(3) provide for 1 or more officers, employees, and
agents, as may be necessary, define their duties, and
require surety bonds or make other provisions against
losses occasioned by acts of such persons;
(4) hire, promote, compensate, and discharge
officers and employees of the Foundation, and define
the duties of the officers and employees;
(5) with the consent of any executive department or
independent agency, use the information, services,
staff, and facilities of such in carrying out this
section;
(6) sue and be sued in its corporate name, and
complain and defend in courts of competent
jurisdiction;
(7) modify or consent to the modification of any
contract or agreement to which it is a party or in
which it has an interest under this part;
(8) establish a process for the selection of
candidates for positions under subsection (c);
(9) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
(10) take such action as may be necessary to obtain
patents and licenses for devices and procedures
developed by the Foundation and its employees;
(11) solicit, accept, hold, administer, invest, and
spend any gift, devise, or bequest of real or personal
property made to the Foundation;
(12) enter into such other contracts, leases,
cooperative agreements, and other transactions as the
Executive Director considers appropriate to conduct the
activities of the Foundation;
(13) appoint other groups of advisors as may be
determined necessary from time to time to carry out the
functions of the Foundation;
(14) enter into such other contracts, leases,
cooperative agreements, and other transactions as the
Executive Director considers appropriate to conduct the
activities of the Foundation; and
(15) exercise other powers as set forth in this
section, and such other incidental powers as are
necessary to carry out its powers, duties, and
functions in accordance with this part.
(i) Administrative Control.--No participant in the program
established under this part shall exercise any administrative
control over any Federal employee.
(7) in paragraphs (1) and (2) of subsection (j) (as
so redesignated), by striking ``(including those
developed under subsection (d)(2)(B)(i)(II))'' each
place it appears.
(j) General Provisions.--
(1) Foundation integrity.--The members of the Board
shall be accountable for the integrity of the
operations of the Foundation and shall ensure such
integrity through the development and enforcement of
criteria and procedures relating to standards of
conduct, financial disclosure statements, conflict of
interest rules, recusal and waiver rules, audits and
other matter determined appropriate by the Board.
(2) Financial conflicts of interest.--Any
individual who is an officer, employee, or member of
the Board of the Foundation may not (in accordance with
policies and requirements developed under subsection
(d)(6)) \1\ personally or substantially participate in
the consideration or determination by the Foundation of
any matter that would directly or predictably affect
any financial interest of the individual or a relative
(as such term is defined in section 109(16) of the
Ethics in Government Act of 1978) of the individual, of
any business organization or other entity, or of which
the individual is an officer or employee, or is
negotiating for employment, or in which the individual
has any other financial interest.
---------------------------------------------------------------------------
\1\ Section 13(7) of Public Law 107-109 (115 Stat. 1419) provided
that paragraphs (1) and (2) of section 499(j) are amended ``by striking
`(including those developed under subsection (d)(2)(B)(i)(II))' each
place it appears''. The term to be struck appeared in paragraph (1),
but not in paragraph (2).
---------------------------------------------------------------------------
(3) Audits; availability of records.--The
Foundation shall--
(A) provide for annual audits of the
financial condition of the Foundation; and
(B) make such audits, and all other
records, documents, and other papers of the
Foundation, available to the Secretary and the
Comptroller General of the United States for
examination or audit.
(4) Reports.--
(A) Not later than 5 months following the
end of each fiscal year, the Foundation shall
publish a report describing the activities of
the Foundation during the preceding fiscal
year. Each such report shall include for the
fiscal year involved a comprehensive statement
of the operations, activities, financial
condition, and accomplishments of the
Foundation, including an accounting of the use
of amounts transferred under subsection (l).
(B) With respect to the financial condition
of the Foundation, each report under
subparagraph (A) shall include the source, and
a description of, all gifts or grants to the
Foundation of real or personal property, and
the source and amount of all gifts or grants to
the Foundation of money. Each such report shall
include a specification of any restrictions on
the purposes for which gifts or grants to the
Foundation may be used.
(C) The Foundation shall make copies of
each report submitted under subparagraph (A)
available--
(i) for public inspection, and
shall upon request provide a copy of
the report to any individual for a
charge that shall not exceed the cost
of providing the copy; and
(ii) to the appropriate committees
of Congress.
(D) The Board shall annually hold a public
meeting to summarize the activities of the
Foundation and distribute written reports
concerning such activities and the scientific
results derived from such activities.
(5) Service of federal employees.--Federal
employees may serve on committees advisory to the
Foundation and otherwise cooperate with and assist the
Foundation in carrying out its function, so long as the
employees do not direct or control Foundation
activities.
(6) Relationship with existing entities.--The
Foundation may, pursuant to appropriate agreements,
merge with, acquire, or use the resources of existing
nonprofit private corporations with missions similar to
the purposes of the Foundation, such as the Foundation
for Advanced Education in the Sciences.
(7) Intellectual property rights.--The Board shall
adopt written standards with respect to the ownership
of any intellectual property rights derived from the
collaborative efforts of the Foundation prior to the
commencement of such efforts.
(8) National institutes of health amendments of
1990.--The activities conducted in support of the
National Institutes of Health Amendments of 1990
(Public Law 101-613), and the amendments made by such
Act, shall not be nullified by the enactment of this
section.
(9) Limitation of activities.--
(A) In general.--The Foundation shall exist
solely as an entity to work in collaboration
with the research programs of the National
Institutes of Health. The Foundation may not
undertake activities (such as the operation of
independent laboratories or competing for
Federal research funds) that are independent of
those of the National Institutes of Health
research programs.
(B) Gifts, grants, and other donations.--
(i) In general.--Gifts, grants, and
other donations to the Foundation may
be designated for pediatric research
and studies on drugs, and funds so
designated shall be used solely for
grants for research and studies under
subsection (c)(1)(C).
(ii) Other gifts.--Other gifts,
grants, or donations received by the
Foundation and not described in clause
(i) may also be used to support such
pediatric research and studies.
(iii) Report.--The recipient of a
grant for research and studies shall
agree to provide the Director of the
National Institutes of Health and the
Commissioner of Food and Drugs, at the
conclusion of the research and
studies--
(I) a report describing the
results of the research and
studies; and
(II) all data generated in
connection with the research
and studies.
(iv) Action by the commissioner of
food and drugs.--The Commissioner of
Food and Drugs shall take appropriate
action in response to a report received
under clause (iii) in accordance with
paragraphs (7) through (12) of section
409I(c), including negotiating with the
holders of approved applications for
the drugs studied for any labeling
changes that the Commissioner
determines to be appropriate and
requests the holders to make.
(C) Applicability.--Subparagraph (A) does
not apply to the program described in
subsection (c)(1)(C).
(10) Transfer of funds.--The Foundation may
transfer funds to the National Institutes of Health and
the National Institutes of Health may accept transfers
of funds from the Foundation. Any funds transferred
under this paragraph shall be subject to all Federal
limitations relating to federally-funded research.
(k) Duties of the Director.--
(1) Applicability of certain standards to non-
federal employees.--In the case of any individual who
is not an employee of the Federal Government and who
serves in association with the National Institutes of
Health, with respect to financial assistance received
from the Foundation, the Foundation may not provide the
assistance of, or otherwise permit the work at the
National Institutes of Health to begin until a
memorandum of understanding between the individual and
the Director of the National Institutes of Health, or
the designee of such Director, has been executed
specifying that the individual shall be subject to such
ethical and procedural standards of conduct relating to
duties performed at the National Institutes of Health,
as the Director of the National Institutes of Health
determines is appropriate.
(2) Support services.--The Director of the National
Institutes of Health may provide facilities, utilities
and support services to the Foundation if it is
determined by the Director to be advantageous to the
research programs of the National Institutes of Health.
(l) Funding.--From amounts appropriated to the National
Institutes of Health, for each fiscal year, the Director of NIH
shall transfer not less than $500,000 and not more than
$1,250,000 to the Foundation.ATTORNEY: CAS (March 29,
2000) deg.
TITLE V--SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
Part A--Organization and General Authorities
SEC. 501. [290AA] SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES
ADMINISTRATION.
(a) Establishment.--The Substance Abuse and Mental Health
Services Administration (hereafter referred to in this title as
the ``Administration'') is an agency of the Service.
(b) Agencies.--The following entities are agencies of the
Administration:
(1) The Center for Substance Abuse Treatment.
(2) The Center for Substance Abuse Prevention.
(3) The Center for Mental Health Services.
(c) Administrator and Deputy Administrator.--
(1) Administrator.--The Administration shall be
headed by an Administrator (hereinafter in this title
referred to as the ``Administrator'') who shall be
appointed by the President, by and with the advice and
consent of the Senate.
(2) Deputy Administrator.--The Administrator, with
the approval of the Secretary, may appoint a Deputy
Administrator and may employ and prescribe the
functions of such officers and employees, including
attorneys, as are necessary to administer the
activities to be carried out through the
Administration.
(d) Authorities.--The Secretary, acting through the
Administrator, shall--
(1) supervise the functions of the agencies of the
Administration in order to assure that the programs
carried out through each such agency receive
appropriate and equitable support and that there is
cooperation among the agencies in the implementation of
such programs;
(2) establish and implement, through the respective
agencies, a comprehensive program to improve the
provision of treatment and related services to
individuals with respect to substance abuse and mental
illness and to improve prevention services, promote
mental health and protect the legal rights of
individuals with mental illnesses and individuals who
are substance abusers;
(3) carry out the administrative and financial
management, policy development and planning,
evaluation, knowledge dissemination, and public
information functions that are required for the
implementation of this title;
(4) assure that the Administration conduct and
coordinate demonstration projects, evaluations, and
service system assessments and other activities
necessary to improve the availability and quality of
treatment, prevention and related services;
(5) support activities that will improve the
provision of treatment, prevention and related
services, including the development of national mental
health and substance abuse goals and model programs;
(6) in cooperation with the National Institutes of
Health, the Centers for Disease Control and the Health
Resources and Services Administration develop
educational materials and intervention strategies to
reduce the risks of HIV or tuberculosis among substance
abusers and individuals with mental illness and to
develop appropriate mental health services for
individuals with such illnesses;
(7) coordinate Federal policy with respect to the
provision of treatment services for substance abuse
utilizing anti-addiction medications, including
methadone;
(8) conduct programs, and assure the coordination
of such programs with activities of the National
Institutes of Health and the Agency for Health Care
Policy Research \1\, as appropriate, to evaluate the
process, outcomes and community impact of treatment and
prevention services and systems of care in order to
identify the manner in which such services can most
effectively be provided;
---------------------------------------------------------------------------
\1\ So in law. See section 101(a) of Public Law 102-321 (106 Stat.
324). Probably should have been ``Agency for Health Care Policy and
Research''. The Agency, however, was redesignated as the Agency for
Health Care Policy and Research by Public Law 106-129 (see 113 Stat.
1653).
---------------------------------------------------------------------------
(9) collaborate with the Director of the National
Institutes of Health in the development of a system by
which the relevant research findings of the National
Institute on Drug Abuse, the National Institute on
Alcohol Abuse and Alcoholism, the National Institute of
Mental Health, and, as appropriate, the Agency for
Health Care Policy Research \1\ are disseminated to
service providers in a manner designed to improve the
delivery and effectiveness of treatment and prevention
services;
(10) encourage public and private entities that
provide health insurance to provide benefits for
substance abuse and mental health services;
(11) promote the integration of substance abuse and
mental health services into the mainstream of the
health care delivery system of the United States;
(12) monitor compliance by hospitals and other
facilities with the requirements of sections 542 and
543;
(13) with respect to grant programs authorized
under this title, assure that--
(A) all grants that are awarded for the
provision of services are subject to
performance and outcome evaluations; and
(B) all grants that are awarded to entities
other than States are awarded only after the
State in which the entity intends to provide
services--
(i) is notified of the pendency of
the grant application; and
(ii) is afforded an opportunity to
comment on the merits of the
application;
(14) assure that services provided with amounts
appropriated under this title are provided bilingually,
if appropriate;
(15) improve coordination among prevention
programs, treatment facilities and nonhealth care
systems such as employers, labor unions, and schools,
and encourage the adoption of employee assistance
programs and student assistance programs;
(16) maintain a clearinghouse for substance abuse
and mental health information to assure the widespread
dissemination of such information to States, political
subdivisions, educational agencies and institutions,
treatment providers, and the general public;
(17) in collaboration with the National Institute
on Aging, and in consultation with the National
Institute on Drug Abuse, the National Institute on
Alcohol Abuse and Alcoholism and the National Institute
of Mental Health, as appropriate, promote and evaluate
substance abuse services for older Americans in need of
such services, and mental health services for older
Americans who are seriously mentally ill; and
(18) promote the coordination of service programs
conducted by other departments, agencies, organizations
and individuals that are or may be related to the
problems of individuals suffering from mental illness
or substance abuse, including liaisons with the Social
Security Administration, Centers for Medicare &
Medicaid Services, and other programs of the
Department, as well as liaisons with the Department of
Education, Department of Justice, and other Federal
Departments and offices, as appropriate.
(e) Associate Administrator for Alcohol Prevention and
Treatment Policy.--
(1) In general.--There may be in the Administration
an Associate Administrator for Alcohol Prevention and
Treatment Policy to whom the Administrator may delegate
the functions of promoting, monitoring, and evaluating
service programs for the prevention and treatment of
alcoholism and alcohol abuse within the Center for
Substance Abuse Prevention, the Center for Substance
Abuse Treatment and the Center for Mental Health
Services, and coordinating such programs among the
Centers, and among the Centers and other public and
private entities. The Associate Administrator also may
ensure that alcohol prevention, education, and policy
strategies are integrated into all programs of the
Centers that address substance abuse prevention,
education, and policy, and that the Center for
Substance Abuse Prevention addresses the Healthy People
2010 goals and the National Dietary Guidelines of the
Department of Health and Human Services and the
Department of Agriculture related to alcohol
consumption.
(2) Plan.--
(A) The Administrator, acting through the
Associate Administrator for Alcohol Prevention
and Treatment Policy, shall develop, and
periodically review and as appropriate revise,
a plan for programs and policies to treat and
prevent alcoholism and alcohol abuse. The plan
shall be developed (and reviewed and revised)
in collaboration with the Directors of the
Centers of the Administration and in
consultation with members of other Federal
agencies and public and private entities.
(B) Not later than 1 year after the date of
the enactment of the ADAMHA Reorganization Act,
the Administrator shall submit to the Congress
the first plan developed under subparagraph
(A).
(3) Report.--
(A) Not less than once during each 2 years,
the Administrator, acting through the Associate
Administrator for Alcohol Prevention and
Treatment Policy, shall prepare a report
describing the alcoholism and alcohol abuse
prevention and treatment programs undertaken by
the Administration and its agencies, and the
report shall include a detailed statement of
the expenditures made for the activities
reported on and the personnel used in
connection with such activities.
(B) Each report under subparagraph (A)
shall include a description of any revisions in
the plan under paragraph (2) made during the
preceding 2 years.
(C) Each report under subparagraph (A)
shall be submitted to the Administrator for
inclusion in the biennial report under
subsection (k).
(f) Associate Administrator for Women's Services.--
(1) Appointment.--The Administrator, with the
approval of the Secretary, shall appoint an Associate
Administrator for Women's Services who shall report
directly to the Administrator.
(2) Duties.--The Associate Administrator appointed
under paragraph (1) shall--
(A) establish a committee to be known as
the Coordinating Committee for Women's Services
(hereafter in this subparagraph referred to as
the ``Coordinating Committee''), which shall be
composed of the Directors of the agencies of
the Administration (or the designees of the
Directors);
(B) acting through the Coordinating
Committee, with respect to women's substance
abuse and mental health services--
(i) identify the need for such
services, and make an estimate each
fiscal year of the funds needed to
adequately support the services;
(ii) identify needs regarding the
coordination of services;
(iii) encourage the agencies of the
Administration to support such
services; and
(iv) assure that the unique needs
of minority women, including Native
American, Hispanic, African-American
and Asian women, are recognized and
addressed within the activities of the
Administration; and
(C) establish an advisory committee to be
known as the Advisory Committee for Women's
Services, which shall be composed of not more
than 10 individuals, a majority of whom shall
be women, who are not officers or employees of
the Federal Government, to be appointed by the
Administrator from among physicians,
practitioners, treatment providers, and other
health professionals, whose clinical practice,
specialization, or professional expertise
includes a significant focus on women's
substance abuse and mental health conditions,
that shall--
(i) advise the Associate
Administrator on appropriate activities
to be undertaken by the agencies of the
Administration with respect to women's
substance abuse and mental health
services, including services which
require a multidisciplinary approach;
(ii) collect and review data,
including information provided by the
Secretary (including the material
referred to in paragraph (3)), and
report biannually to the Administrator
regarding the extent to which women are
represented among senior personnel, and
make recommendations regarding
improvement in the participation of
women in the workforce of the
Administration; and
(iii) prepare, for inclusion in the
biennial report required pursuant to
subsection (k), a description of
activities of the Committee, including
findings made by the Committee
regarding--
(I) the extent of
expenditures made for women's
substance abuse and mental
health services by the agencies
of the Administration; and
(II) the estimated level of
funding needed for substance
abuse and mental health
services to meet the needs of
women;
(D) improve the collection of data on
women's health by--
(i) reviewing the current data at
the Administration to determine its
uniformity and applicability;
(ii) developing standards for all
programs funded by the Administration
so that data are, to the extent
practicable, collected and reported
using common reporting formats,
linkages and definitions; and
(iii) reporting to the
Administrator a plan for incorporating
the standards developed under clause
(ii) in all Administration programs and
a plan to assure that the data so
collected are accessible to health
professionals, providers, researchers,
and members of the public; and
(E) shall establish, maintain, and operate
a program to provide information on women's
substance abuse and mental health services.
(3) Study.--
(A) The Secretary, acting through the
Assistant Secretary for Personnel, shall
conduct a study to evaluate the extent to which
women are represented among senior personnel at
the Administration.
(B) Not later than 90 days after the date
of the enactment of the ADAMHA Reorganization
Act, the Assistant Secretary for Personnel
shall provide the Advisory Committee for
Women's Services with a study plan, including
the methodology of the study and any sampling
frames. Not later than 180 days after such date
of enactment, the Assistant Secretary shall
prepare and submit directly to the Advisory
Committee a report concerning the results of
the study conducted under subparagraph (A).
(C) The Secretary shall prepare and provide
to the Advisory Committee for Women's Services
any additional data as requested.
(4) Office.--Nothing in this subsection shall be
construed to preclude the Secretary from establishing
within the Substance Abuse and Mental Health
Administration an Office of Women's Health.
(5) Definition.--For purposes of this subsection,
the term ``women's substance abuse and mental health
conditions'', with respect to women of all age, ethnic,
and racial groups, means all aspects of substance abuse
and mental illness--
(A) unique to or more prevalent among
women; or
(B) with respect to which there have been
insufficient services involving women or
insufficient data.
(g) Services of Experts.--
(1) In general.--The Administrator may obtain (in
accordance with section 3109 of title 5, United States
Code, but without regard to the limitation in such
section on the number of days or the period of service)
the services of not more than 20 experts or consultants
who have professional qualifications. Such experts and
consultants shall be obtained for the Administration
and for each of its agencies.
(2) Compensation and expenses.--
(A) Experts and consultants whose services
are obtained under paragraph (1) shall be paid
or reimbursed for their expenses associated
with traveling to and from their assignment
location in accordance with sections 5724,
5724a(a), 5724a(c), and 5726(c) of title 5,
United States Code.
(B) Expenses specified in subparagraph (A)
may not be allowed in connection with the
assignment of an expert or consultant whose
services are obtained under paragraph (1),
unless and until the expert or consultant
agrees in writing to complete the entire period
of assignment or one year, whichever is
shorter, unless separated or reassigned for
reasons beyond the control of the expert or
consultant that are acceptable to the
Secretary. If the expert or consultant violates
the agreement, the money spent by the United
States for the expenses specified in
subparagraph (A) is recoverable from the expert
or consultant as a debt of the United States.
The Secretary may waive in whole or in part a
right of recovery under this subparagraph.
(h) Peer Review Groups.--The Administrator shall, without
regard to the provisions of title 5, United States Code,
governing appointments in the competitive service, and without
regard to the provisions of chapter 51 and subchapter III of
chapter 53 of such title, relating to classification and
General Schedule pay rates, establish such peer review groups
and program advisory committees as are needed to carry out the
requirements of this title and appoint and pay members of such
groups, except that officers and employees of the United States
shall not receive additional compensation for services as
members of such groups. The Federal Advisory Committee Act
shall not apply to the duration of a peer review group
appointed under this subsection.
(i) Voluntary Services.--The Administrator may accept
voluntary and uncompensated services.
(j) Administration.--The Administrator shall ensure that
programs and activities assigned under this title to the
Administration are fully administered by the respective Centers
to which such programs and activities are assigned.
(k) Report Concerning Activities and Progress.--Not later
than February 10, 1994, and once every 2 years thereafter, the
Administrator shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, the
report containing--
(1) a description of the activities carried out by
the Administration;
(2) a description of any measurable progress made
in improving the availability and quality of substance
abuse and mental health services;
(3) a description of the mechanisms by which
relevant research findings of the National Institute on
Drug Abuse, the National Institute on Alcohol Abuse and
Alcoholism, and the National Institute of Mental Health
have been disseminated to service providers or
otherwise utilized by the Administration to further the
purposes of this title; and
(4) any report required in this title to be
submitted to the Adminstrator \1\ for inclusion in the
report under this subsection.
---------------------------------------------------------------------------
\1\ So in law. See section 101(a) of Public Law 102-321 (106 Stat.
324). Probably should be ``Administrator''.
---------------------------------------------------------------------------
(l) Applications for Grants and Contracts.--With respect to
awards of grants, cooperative agreements, and contracts under
this title, the Administrator, or the Director of the Center
involved, as the case may be, may not make such an award
unless--
(1) an application for the award is submitted to
the official involved;
(2) with respect to carrying out the purpose for
which the award is to be provided, the application
provides assurances of compliance satisfactory to such
official; and
(3) the application is otherwise in such form, is
made in such manner, and contains such agreements,
assurances, and information as the official determines
to be necessary to carry out the purpose for which the
award is to be provided.
(m) Emergency Response.--
(1) In general.--Notwithstanding section 504 and
except as provided in paragraph (2), the Secretary may
use not to exceed 2.5 percent of all amounts
appropriated under this title for a fiscal year to make
noncompetitive grants, contracts or cooperative
agreements to public entities to enable such entities
to address emergency substance abuse or mental health
needs in local communities.
(2) Exceptions.--Amounts appropriated under part C
shall not be subject to paragraph (1).
(3) Emergencies.--The Secretary shall establish
criteria for determining that a substance abuse or
mental health emergency exists and publish such
criteria in the Federal Register prior to providing
funds under this subsection.
(n) Limitation on the Use of Certain Information.--No
information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the
course of activities undertaken or supported under section 505
may be used for any purpose other than the purpose for which it
was supplied unless such establishment or person has consented
(as determined under regulations of the Secretary) to its use
for such other purpose. Such information may not be published
or released in other form if the person who supplied the
information or who is described in it is identifiable unless
such person has consented (as determined under regulations of
the Secretary) to its publication or release in other form.
(o) Authorization of Appropriations.--For the purpose of
providing grants, cooperative agreements, and contracts under
this section, there are authorized to be appropriated
$25,000,000 for fiscal year 2001, and such sums as may be
necessary for each of the fiscal years 2002 and 2003.
advisory councils
Sec. 502. [290aa-1] (a) Appointment.--
(1) In general.--The Secretary shall appoint an
advisory council for--
(A) the Substance Abuse and Mental Health
Services Administration;
(B) the Center for Substance Abuse
Treatment;
(C) the Center for Substance Abuse
Prevention; and
(D) the Center for Mental Health Services.
Each such advisory council shall advise, consult with,
and make recommendations to the Secretary and the
Administrator or Director of the Administration or
Center for which the advisory council is established
concerning matters relating to the activities carried
out by and through the Administration or Center and the
policies respecting such activities.
(2) Function and activities.--An advisory council--
(A)(i) may on the basis of the materials
provided by the organization respecting
activities conducted at the organization, make
recommendations to the Administrator or
Director of the Administration or Center for
which it was established respecting such
activities;
(ii) shall review applications submitted
for grants and cooperative agreements for
activities for which advisory council approval
is required under section 504(d)(2) and
recommend for approval applications for
projects that show promise of making valuable
contributions to the Administration's mission;
and
(iii) may review any grant, contract, or
cooperative agreement proposed to be made or
entered into by the organization;
(B) may collect, by correspondence or by
personal investigation, information as to
studies and services that are being carried on
in the United States or any other country as to
the diseases, disorders, or other aspects of
human health with respect to which the
organization was established and with the
approval of the Administrator or Director,
whichever is appropriate, make such information
available through appropriate publications for
the benefit of public and private health
entities and health professions personnel and
for the information of the general public; and
(C) may appoint subcommittees and convene
workshops and conferences.
(b) Membership.--
(1) In general.--Each advisory council shall
consist of nonvoting ex officio members and not more
than 12 members to be appointed by the Secretary under
paragraph (3).
(2) Ex officio members.--The ex officio members of
an advisory council shall consist of--
(A) the Secretary;
(B) the Administrator;
(C) the Director of the Center for which
the council is established;
(D) the Under Secretary for Health of the
Department of Veterans Affairs;
(E) the Assistant Secretary for Defense for
Health Affairs (or the designates of such
officers); and
(F) such additional officers or employees
of the United States as the Secretary
determines necessary for the advisory council
to effectively carry out its functions.
(3) Appointed members.--Individuals shall be
appointed to an advisory council under paragraph (1) as
follows:
(A) Nine of the members shall be appointed
by the Secretary from among the leading
representatives of the health disciplines
(including public health and behavioral and
social sciences) relevant to the activities of
the Administration or Center for which the
advisory council is established.
(B) Three of the members shall be appointed
by the Secretary from the general public and
shall include leaders in fields of public
policy, public relations, law, health policy
economics, or management.
(4) Compensation.--Members of an advisory council
who are officers or employees of the United States
shall not receive any compensation for service on the
advisory council. The remaining members of an advisory
council shall receive, for each day (including travel
time) they are engaged in the performance of the
functions of the advisory council, compensation at
rates not to exceed the daily equivalent to the annual
rate in effect for grade GS-18 of the General Schedule.
(c) Terms of Office.--
(1) In general.--The term of office of a member of
an advisory council appointed under subsection (b)
shall be 4 years, except that any member appointed to
fill a vacancy for an unexpired term shall serve for
the remainder of such term. The Secretary shall make
appointments to an advisory council in such a manner as
to ensure that the terms of the members not all expire
in the same year. A member of an advisory council may
serve after the expiration of such member's term until
a successor has been appointed and taken office.
(2) Reappointments.--A member who has been
appointed to an advisory council for a term of 4 years
may not be reappointed to an advisory council during
the 2-year period beginning on the date on which such
4-year term expired.
(3) Time for appointment.--If a vacancy occurs in
an advisory council among the members under subsection
(b), the Secretary shall make an appointment to fill
such vacancy within 90 days from the date the vacancy
occurs.
(d) Chair.--The Secretary shall select a member of an
advisory council to serve as the chair of the council. The
Secretary may so select an individual from among the appointed
members, or may select the Administrator or the Director of the
Center involved. The term of office of the chair shall be 2
years.
(e) Meetings.--An advisory council shall meet at the call
of the chairperson or upon the request of the Administrator or
Director of the Administration or Center for which the advisory
council is established, but in no event less than 2 times
during each fiscal year. The location of the meetings of each
advisory council shall be subject to the approval of the
Administrator or Director of Administration or Center for which
the council was established.
(f) Executive Secretary and Staff.--The Administrator or
Director of the Administration or Center for which the advisory
council is established shall designate a member of the staff of
the Administration or Center for which the advisory council is
established to serve as the Executive Secretary of the advisory
council. The Administrator or Director shall make available to
the advisory council such staff, information, and other
assistance as it may require to carry out its functions. The
Administrator or Director shall provide orientation and
training for new members of the advisory council to provide for
their effective participation in the functions of the advisory
council.
reports on alcoholism, alcohol abuse, and drug abuse
Sec. 503. [290aa-2] (a) The Secretary shall submit to
Congress on or before January 15, 1984, and every three years
thereafter a report--
(1) containing current information on the health
consequences of using alcoholic beverages,
(2) containing a description of current research
findings made with respect to alcohol abuse and
alcoholism, and
(3) containing such recommendations for legislation
and administrative action as the Secretary may deem
appropriate.
(b) The Secretary shall submit to Congress on or before
January 15, 1984, and every three years thereafter a report--
(1) describing the health consequences and extent
of drug abuse in the United States;
(2) describing current research findings made with
respect to drug abuse, including current findings on
the health effects of marihuana and the addictive
property of tobacco; and
(3) containing such recommendations for legislation
and administrative action as the Secretary may deem
appropriate.
SEC. 503A. [290AA-2A] REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL
ILLNESS AND SUBSTANCE ABUSE DISORDERS.
(a) In General.--Not later than 2 years after the date of
the enactment of this section, the Secretary shall, after
consultation with organizations representing States, mental
health and substance abuse treatment providers, prevention
specialists, individuals receiving treatment services, and
family members of such individuals, prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Commerce of the House of
Representatives, a report on prevention and treatment services
for individuals who have co-occurring mental illness and
substance abuse disorders.
(b) Report Content.--The report under subsection (a) shall
be based on data collected from existing Federal and State
surveys regarding the treatment of co-occurring mental illness
and substance abuse disorders and shall include--
(1) a summary of the manner in which individuals
with co-occurring disorders are receiving treatment,
including the most up-to-date information available
regarding the number of children and adults with co-
occurring mental illness and substance abuse disorders
and the manner in which funds provided under sections
1911 and 1921 are being utilized, including the number
of such children and adults served with such funds;
(2) a summary of improvements necessary to ensure
that individuals with co-occurring mental illness and
substance abuse disorders receive the services they
need;
(3) a summary of practices for preventing substance
abuse among individuals who have a mental illness and
are at risk of having or acquiring a substance abuse
disorder; and
(4) a summary of evidenced-based practices for
treating individuals with co-occurring mental illness
and substance abuse disorders and recommendations for
implementing such practices.
(c) Funds for Report.--The Secretary may obligate funds to
carry out this section with such appropriations as are
available.
SEC. 504. \1\ [290AA-3] PEER REVIEW.
---------------------------------------------------------------------------
\1\ Section 504 appears according to the probable intent of the
Congress. Section 3401(b) of Public Law 106-310 (114 Stat. 1218)
provides that the section ``is amended as follows:''. No amendatory
instructions were then given, but a substitute text was provided. The
amendment probably should have instructed that section 504 ``is amended
to read as follows:''.
---------------------------------------------------------------------------
(a) In General.--The Secretary, after consultation with the
Administrator, shall require appropriate peer review of grants,
cooperative agreements, and contracts to be administered
through the agency which exceed the simple acquisition
threshold as defined in section 4(11) of the Office of Federal
Procurement Policy Act.
(b) Members.--The members of any peer review group
established under subsection (a) shall be individuals who by
virtue of their training or experience are eminently qualified
to perform the review functions of the group. Not more than
one-fourth of the members of any such peer review group shall
be officers or employees of the United States.
(c) Advisory Council Review.--If the direct cost of a grant
or cooperative agreement (described in subsection (a)) exceeds
the simple acquisition threshold as defined by section 4(11) of
the Office of Federal Procurement Policy Act, the Secretary may
make such a grant or cooperative agreement only if such grant
or cooperative agreement is recommended--
(1) after peer review required under subsection
(a); and
(2) by the appropriate advisory council.
(d) Conditions.--The Secretary may establish limited
exceptions to the limitations contained in this section
regarding participation of Federal employees and advisory
council approval. The circumstances under which the Secretary
may make such an exception shall be made public.
data collection \1\
Sec. 505. [290aa-4] (a) The Secretary, acting through the
Administrator, shall collect data each year on--
---------------------------------------------------------------------------
\1\ Section 502 of Public Law 104-237 (110 Stat. 3112) provides as
follows:
``The Secretary of Health and Human Services shall develop a public
health monitoring program to monitor methamphetamine abuse in the
United States. The program shall include the collection and
dissemination of data related to methamphetamine abuse which can be
used by public health officials in policy development.''.
---------------------------------------------------------------------------
(1) the national incidence and prevalence of the
various forms of mental illness and substance abuse;
and
(2) the incidence and prevalence of such various
forms in major metropolitan areas selected by the
Administrator.
(b) With respect to the activities of the Administrator
under subsection (a) relating to mental health, the
Administrator shall ensure that such activities include, at a
minimum, the collection of data on--
(1) the number and variety of public and nonprofit
private treatment programs;
(2) the number and demographic characteristics of
individuals receiving treatment through such programs;
(3) the type of care received by such individuals;
and
(4) such other data as may be appropriate.
(c)(1) With respect to the activities of the Administrator
under subsection (a) relating to substance abuse, the
Administrator shall ensure that such activities include, at a
minimum, the collection of data on--
(A) the number of individuals admitted to the
emergency rooms of hospitals as a result of the abuse
of alcohol or other drugs;
(B) the number of deaths occurring as a result of
substance abuse, as indicated in reports by coroners;
(C) the number and variety of public and private
nonprofit treatment programs, including the number and
type of patient slots available;
(D) the number of individuals seeking treatment
through such programs, the number and demographic
characteristics of individuals receiving such
treatment, the percentage of individuals who complete
such programs, and, with respect to individuals
receiving such treatment, the length of time between an
individual's request for treatment and the commencement
of treatment;
(E) the number of such individuals who return for
treatment after the completion of a prior treatment in
such programs and the method of treatment utilized
during the prior treatment;
(F) the number of individuals receiving public
assistance for such treatment programs;
(G) the costs of the different types of treatment
modalities for drug and alcohol abuse and the aggregate
relative costs of each such treatment modality provided
within a State in each fiscal year;
(H) to the extent of available information, the
number of individuals receiving treatment for alcohol
or drug abuse who have private insurance coverage for
the costs of such treatment;
(I) the extent of alcohol and drug abuse among high
school students and among the general population; and
(J) the number of alcohol and drug abuse counselors
and other substance abuse treatment personnel employed
in public and private treatment facilities.
(2) Annual surveys shall be carried out in the collection
of data under this subsection. Summaries and analyses of the
data collected shall be made available to the public.
(d) After consultation with the States and with appropriate
national organizations, the Administrator shall develop uniform
criteria for the collection of data, using the best available
technology, pursuant to this section.
SEC. 506. [290AA-5] GRANTS FOR THE BENEFIT OF HOMELESS INDIVIDUALS.
(a) In General.--The Secretary shall award grants,
contracts and cooperative agreements to community-based public
and private nonprofit entities for the purposes of providing
mental health and substance abuse services for homeless
individuals. In carrying out this section, the Secretary shall
consult with the Interagency Council on the Homeless,
established under section 201 of the Stewart B. McKinney
Homeless Assistance Act (42 U.S.C. 11311).
(b) Preferences.--In awarding grants, contracts, and
cooperative agreements under subsection (a), the Secretary
shall give a preference to--
(1) entities that provide integrated primary
health, substance abuse, and mental health services to
homeless individuals;
(2) entities that demonstrate effectiveness in
serving runaway, homeless, and street youth;
(3) entities that have experience in providing
substance abuse and mental health services to homeless
individuals;
(4) entities that demonstrate experience in
providing housing for individuals in treatment for or
in recovery from mental illness or substance abuse; and
(5) entities that demonstrate effectiveness in
serving homeless veterans.
(c) Services for Certain Individuals.--In awarding grants,
contracts, and cooperative agreements under subsection (a), the
Secretary shall not--
(1) prohibit the provision of services under such
subsection to homeless individuals who are suffering
from a substance abuse disorder and are not suffering
from a mental health disorder; and
(2) make payments under subsection (a) to any
entity that has a policy of--
(A) excluding individuals from mental
health services due to the existence or
suspicion of substance abuse; or
(B) has a policy of excluding individuals
from substance abuse services due to the
existence or suspicion of mental illness.
(d) Term of the Awards.--No entity may receive a grant,
contract, or cooperative agreement under subsection (a) for
more than 5 years.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $50,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003.
SEC. 506A. [290AA-5A] ALCOHOL AND DRUG PREVENTION OR TREATMENT SERVICES
FOR INDIANS AND NATIVE ALASKANS. \1\
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\1\ Section 3307 of Public Law 106-310 (114 Stat. 1216) establishes
a Commission on Indian and Native Alaskan Health Care and provides that
the Commission ``shall examine the health concerns of Indians and
Native Alaskans who reside on reservations and tribal lands''.
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(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to public and private
nonprofit entities, including Native Alaskan entities and
Indian tribes and tribal organizations, for the purpose of
providing alcohol and drug prevention or treatment services for
Indians and Native Alaskans.
(b) Priority.--In awarding grants, contracts, or
cooperative agreements under subsection (a), the Secretary
shall give priority to applicants that--
(1) propose to provide alcohol and drug prevention
or treatment services on reservations;
(2) propose to employ culturally-appropriate
approaches, as determined by the Secretary, in
providing such services; and
(3) have provided prevention or treatment services
to Native Alaskan entities and Indian tribes and tribal
organizations for at least 1 year prior to applying for
a grant under this section.
(c) Duration.--The Secretary shall award grants, contracts,
or cooperative agreements under subsection (a) for a period not
to exceed 5 years.
(d) Application.--An entity desiring a grant, contract, or
cooperative agreement under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
(e) Evaluation.--An entity that receives a grant, contract,
or cooperative agreement under subsection (a) shall submit, in
the application for such grant, a plan for the evaluation of
any project undertaken with funds provided under this section.
Such entity shall provide the Secretary with periodic
evaluations of the progress of such project and such evaluation
at the completion of such project as the Secretary determines
to be appropriate. The final evaluation submitted by such
entity shall include a recommendation as to whether such
project shall continue.
(f ) Report.--Not later than 3 years after the date of the
enactment of this section and annually thereafter, the
Secretary shall prepare and submit, to the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
describing the services provided pursuant to this section.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $15,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 and 2003.
SEC. 506B. [290AA-5B] GRANTS FOR ECSTASY AND OTHER CLUB DRUGS ABUSE
PREVENTION.
(a) Authority.--The Administrator may make grants to, and
enter into contracts and cooperative agreements with, public
and nonprofit private entities to enable such entities--
(1) to carry out school-based programs concerning
the dangers of the abuse of and addiction to 3,4-
methylenedioxy methamphetamine, related drugs, and
other drugs commonly referred to as ``club drugs''
using methods that are effective and science-based,
including initiatives that give students the
responsibility to create their own anti-drug abuse
education programs for their schools; and
(2) to carry out community-based abuse and
addiction prevention programs relating to 3,4-
methylenedioxy methamphetamine, related drugs, and
other club drugs that are effective and science-based.
(b) Use of Funds.--Amounts made available under a grant,
contract or cooperative agreement under subsection (a) shall be
used for planning, establishing, or administering prevention
programs relating to 3,4-methylenedioxy methamphetamine,
related drugs, and other club drugs.
(c) Use of Funds.--
(1) Discretionary functions.--Amounts provided to
an entity under this section may be used--
(A) to carry out school-based programs that
are focused on those districts with high or
increasing rates of abuse and addiction to 3,4-
methylenedioxy methamphetamine, related drugs,
and other club drugs and targeted at
populations that are most at risk to start
abusing these drugs;
(B) to carry out community-based prevention
programs that are focused on those populations
within the community that are most at-risk for
abuse of and addiction to 3,4-methylenedioxy
methamphetamine, related drugs, and other club
drugs;
(C) to assist local government entities to
conduct appropriate prevention activities
relating to 3,4-methylenedioxy methamphetamine,
related drugs, and other club drugs;
(D) to train and educate State and local
law enforcement officials, prevention and
education officials, health professionals,
members of community anti-drug coalitions and
parents on the signs of abuse of and addiction
to 3,4-methylenedioxy methamphetamine, related
drugs, and other club drugs and the options for
treatment and prevention;
(E) for planning, administration, and
educational activities related to the
prevention of abuse of and addiction to 3,4-
methylenedioxy methamphetamine, related drugs,
and other club drugs;
(F) for the monitoring and evaluation of
prevention activities relating to 3,4-
methylenedioxy methamphetamine, related drugs,
and other club drugs and reporting and
disseminating resulting information to the
public; and
(G) for targeted pilot programs with
evaluation components to encourage innovation
and experimentation with new methodologies.
(2) Priority.--The Administrator shall give
priority in awarding grants under this section to rural
and urban areas that are experiencing a high rate or
rapid increases in abuse and addiction to 3,4-
methylenedioxy methamphetamine, related drugs, and
other club drugs.
(d) Allocation and Report.--
(1) Prevention program allocation.--Not less than
$500,000 of the amount appropriated in each fiscal year
to carry out this section shall be made available to
the Administrator, acting in consultation with other
Federal agencies, to support and conduct periodic
analyses and evaluations of effective prevention
programs for abuse of and addiction to 3,4-
methylenedioxy methamphetamine, related drugs, and
other club drugs and the development of appropriate
strategies for disseminating information about and
implementing such programs.
(2) Report.--The Administrator shall annually
prepare and submit to the Committee on Health,
Education, Labor, and Pensions, the Committee on the
Judiciary, and the Committee on Appropriations of the
Senate, and the Committee on Commerce, the Committee on
the Judiciary, and the Committee on Appropriations of
the House of Representatives, a report containing the
results of the analyses and evaluations conducted under
paragraph (1).
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section--
(1) $10,000,000 for fiscal year 2001; and
(2) such sums as may be necessary for each
succeeding fiscal year.
Part B--Centers and Programs
Subpart 1--Center for Substance Abuse Treatment
center for substance abuse treatment \1\
Sec. 507. [290bb] (a) Establishment.--There is established
in the Administration a Center for Substance Abuse Treatment
(hereafter in this section referred to as the ``Center''). The
Center shall be headed by a Director (hereafter in this section
referred to as the ``Director'') appointed by the Secretary
from among individuals with extensive experience or academic
qualifications in the treatment of substance abuse or in the
evaluation of substance abuse treatment systems.
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\1\ Section 4 of Public Law 108-358 (118 Stat. 1664) authorizes the
Secretary of Health and Human Services to ``award grants to public and
nonprofit private entities to enable such entities to carry out
science-based education programs in elementary and secondary schools to
highlight the harmful effects of anabolic steroids''. Subsection (d) of
such section provides that there is authorized to be appropriated to
carry out the section $15,000,000 for each of the fiscal years 2005
through 2010.
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(b) Duties.--The Director of the Center shall--
(1) administer the substance abuse treatment block
grant program authorized in section 1921;
(2) ensure that emphasis is placed on children and
adolescents in the development of treatment programs;
(3) collaborate with the Attorney General to
develop programs to provide substance abuse treatment
services to individuals who have had contact with the
Justice system, especially adolescents;
(4) collaborate with the Director of the Center for
Substance Abuse Prevention in order to provide outreach
services to identify individuals in need of treatment
services, with emphasis on the provision of such
services to pregnant and postpartum women and their
infants and to individuals who abuse drugs
intravenously;
(5) collaborate with the Director of the National
Institute on Drug Abuse, with the Director of the
National Institute on Alcohol Abuse and Alcoholism, and
with the States to promote the study, dissemination,
and implementation of research findings that will
improve the delivery and effectiveness of treatment
services;
(6) collaborate with the Administrator of the
Health Resources and Services Administration and the
Administrator of the Centers for Medicare & Medicaid
Services to promote the increased integration into the
mainstream of the health care system of the United
States of programs for providing treatment services;
(7) evaluate plans submitted by the States pursuant
to section 1932(a)(6) in order to determine whether the
plans adequately provide for the availability,
allocation, and effectiveness of treatment services;
(8) sponsor regional workshops on improving the
quality and availability of treatment services;
(9) provide technical assistance to public and
nonprofit private entities that provide treatment
services, including technical assistance with respect
to the process of submitting to the Director
applications for any program of grants or contracts
carried out by the Director;
(10) encourage the States to expand the
availability (relative to fiscal year 1992) of programs
providing treatment services through self-run, self-
supported recovery based on the programs of housing
operated pursuant to section 1925;
(11) carry out activities to educate individuals on
the need for establishing treatment facilities within
their communities;
(12) encourage public and private entities that
provide health insurance to provide benefits for
outpatient treatment services and other nonhospital-
based treatment services;
(13) evaluate treatment programs to determine the
quality and appropriateness of various forms of
treatment, which shall be carried out through grants,
contracts, or cooperative agreements provided to public
or nonprofit private entities; and
(14) in carrying out paragraph (13), assess the
quality, appropriateness, and costs of various
treatment forms for specific patient groups.
(c) Grants and Contracts.--In carrying out the duties
established in subsection (b), the Director may make grants to
and enter into contracts and cooperative agreements with public
and nonprofit private entities.
residential treatment programs for pregnant and postpartum women
Sec. 508. [290bb-1] (a) In General.--The Director of the
Center for Substance Abuse Treatment shall provide awards of
grants, cooperative agreement, or contracts to public and
nonprofit private entities for the purpose of providing to
pregnant and postpartum women treatment for substance abuse
through programs in which, during the course of receiving
treatment--
(1) the women reside in facilities provided by the
programs;
(2) the minor children of the women reside with the
women in such facilities, if the women so request; and
(3) the services described in subsection (d) are
available to or on behalf of the women.
(b) Availability of Services for Each Participant.--A
funding agreement for an award under subsection (a) for an
applicant is that, in the program operated pursuant to such
subsection--
(1) treatment services and each supplemental
service will be available through the applicant, either
directly or through agreements with other public or
nonprofit private entities; and
(2) the services will be made available to each
woman admitted to the program.
(c) Individualized Plan of Services.--A funding agreement
for an award under subsection (a) for an applicant is that--
(1) in providing authorized services for an
eligible woman pursuant to such subsection, the
applicant will, in consultation with the women, prepare
an individualized plan for the provision to the woman
of the services; and
(2) treatment services under the plan will
include--
(A) individual, group, and family
counseling, as appropriate, regarding substance
abuse; and
(B) follow-up services to assist the woman
in preventing a relapse into such abuse.
(d) Required Supplemental Services.--In the case of an
eligible woman, the services referred to in subsection (a)(3)
are as follows:
(1) Prenatal and postpartum health care.
(2) Referrals for necessary hospital services.
(3) For the infants and children of the woman--
(A) pediatric health care, including
treatment for any perinatal effects of maternal
substance abuse and including screenings
regarding the physical and mental development
of the infants and children;
(B) counseling and other mental health
services, in the case of children; and
(C) comprehensive social services.
(4) Providing supervision of children during
periods in which the woman is engaged in therapy or in
other necessary health or rehabilitative activities.
(5) Training in parenting.
(6) Counseling on the human immunodeficiency virus
and on acquired immune deficiency syndrome.
(7) Counseling on domestic violence and sexual
abuse.
(8) Counseling on obtaining employment, including
the importance of graduating from a secondary school.
(9) Reasonable efforts to preserve and support the
family units of the women, including promoting the
appropriate involvement of parents and others, and
counseling the children of the women.
(10) Planning for and counseling to assist reentry
into society, both before and after discharge,
including referrals to any public or nonprofit private
entities in the community involved that provide
services appropriate for the women and the children of
the women.
(11) Case management services, including--
(A) assessing the extent to which
authorized services are appropriate for the
women and their children;
(B) in the case of the services that are
appropriate, ensuring that the services are
provided in a coordinated manner; and
(C) assistance in establishing eligibility
for assistance under Federal, State, and local
programs providing health services, mental
health services, housing services, employment
services, educational services, or social
services.
(e) Minimum Qualifications For Receipt of Award.--
(1) Certification by relevant state agency.--With
respect to the principal agency of the State involved
that administers programs relating to substance abuse,
the Director may make an award under subsection (a) to
an applicant only if the agency has certified to the
Director that--
(A) the applicant has the capacity to carry
out a program described in subsection (a);
(B) the plans of the applicant for such a
program are consistent with the policies of
such agency regarding the treatment of
substance abuse; and
(C) the applicant, or any entity through
which the applicant will provide authorized
services, meets all applicable State licensure
or certification requirements regarding the
provision of the services involved.
(2) Status as medicaid provider.--
(A) Subject to subparagraphs (B) and (C),
the Director may make an award under subsection
(a) only if, in the case of any authorized
service that is available pursuant to the State
plan approved under title XIX of the Social
Security Act for the State involved--
(i) the applicant for the award
will provide the service directly, and
the applicant has entered into a
participation agreement under the State
plan and is qualified to receive
payments under such plan; or
(ii) the applicant will enter into
an agreement with a public or nonprofit
private entity under which the entity
will provide the service, and the
entity has entered into such a
participation agreement plan and is
qualified to receive such payments.
(B)(i) In the case of an entity making an
agreement pursuant to subparagraph (A)(ii)
regarding the provision of services, the
requirement established in such subparagraph
regarding a participation agreement shall be
waived by the Director if the entity does not,
in providing health care services, impose a
charge or accept reimbursement available from
any third-party payor, including reimbursement
under any insurance policy or under any Federal
or State health benefits plan.
(ii) A determination by the Director of
whether an entity referred to in clause (i)
meets the criteria for a waiver under such
clause shall be made without regard to whether
the entity accepts voluntary donations
regarding the provision of services to the
public.
(C) With respect to any authorized service
that is available pursuant to the State plan
described in subparagraph (A), the requirements
established in such subparagraph shall not
apply to the provision of any such service by
an institution for mental diseases to an
individual who has attained 21 years of age and
who has not attained 65 years of age. For
purposes of the preceding sentence, the term
``institution for mental diseases'' has the
meaning given such term in section 1905(i) of
the Social Security Act.
(f) Requirement of Matching Funds.--
(1) In general.--With respect to the costs of the
program to be carried out by an applicant pursuant to
subsection (a), a funding agreement for an award under
such subsection is that the applicant will make
available (directly or through donations from public or
private entities) non-Federal contributions toward such
costs in an amount that--
(A) for the first fiscal year for which the
applicant receives payments under an award
under such subsection, is not less than $1 for
each $9 of Federal funds provided in the award;
(B) for any second such fiscal year, is not
less than $1 for each $9 of Federal funds
provided in the award; and
(C) for any subsequent such fiscal year, is
not less than $1 for each $3 of Federal funds
provided in the award.
(2) Determination of amount contributed.--Non-
Federal contributions required in paragraph (1) may be
in cash or in kind, fairly evaluated, including plant,
equipment, or services. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such non-
Federal contributions.
(g) Outreach.--A funding agreement for an award under
subsection (a) for an applicant is that the applicant will
provide outreach services in the community involved to identify
women who are engaging in substance abuse and to encourage the
women to undergo treatment for such abuse.
(h) Accessibility of Program; Cultural Context of
Services.--A funding agreement for an award under subsection
(a) for an applicant is that--
(1) the program operated pursuant to such
subsection will be operated at a location that is
accessible to low-income pregnant and postpartum women;
and
(2) authorized services will be provided in the
language and the cultural context that is most
appropriate.
(i) Continuing Education.--A funding agreement for an award
under subsection (a) is that the applicant involved will
provide for continuing education in treatment services for the
individuals who will provide treatment in the program to be
operated by the applicant pursuant to such subsection.
(j) Imposition of Charges.--A funding agreement for an
award under subsection (a) for an applicant is that, if a
charge is imposed for the provision of authorized services to
on \1\ behalf of an eligible woman, such charge--
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\1\ So in law. See section 108(a) of Public Law 102-321 (106 Stat.
336). Probably should be ``to or on''.
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(1) will be made according to a schedule of charges
that is made available to the public;
(2) will be adjusted to reflect the income of the
woman involved; and
(3) will not be imposed on any such woman with an
income of less than 185 percent of the official poverty
line, as established by the Director of the Office for
Management and Budget and revised by the Secretary in
accordance with section 673(2) of the Omnibus Budget
Reconciliation Act of 1981.
(k) Reports to Director.--A funding agreement for an award
under subsection (a) is that the applicant involved will submit
to the Director a report--
(1) describing the utilization and costs of
services provided under the award;
(2) specifying the number of women served, the
number of infants served, and the type and costs of
services provided; and
(3) providing such other information as the
Director determines to be appropriate.
(l) Requirement of Application.--The Director may make an
award under subsection (a) only if an application for the award
is submitted to the Director containing such agreements, and
the application is in such form, is made in such manner, and
contains such other agreements and such assurances and
information as the Director determines to be necessary to carry
out this section.
(m) Equitable Allocation of Awards.--In making awards under
subsection (a), the Director shall ensure that the awards are
equitably allocated among the principal geographic regions of
the United States, subject to the availability of qualified
applicants for the awards.
(n) Duration of Award.--The period during which payments
are made to an entity from an award under subsection (a) may
not exceed 5 years. The provision of such payments shall be
subject to annual approval by the Director of the payments and
subject to the availability of appropriations for the fiscal
year involved to make the payments. This subsection may not be
construed to establish a limitation on the number of awards
under such subsection that may be made to an entity.
(o) Evaluations; Dissemination of Findings.--The Director
shall, directly or through contract, provide for the conduct of
evaluations of programs carried out pursuant to subsection (a).
The Director shall disseminate to the States the findings made
as a result of the evaluations.
(p) Reports to Congress.--Not later than October 1, 1994,
the Director shall submit to the Committee on Energy and
Commerce of the House of Representatives, and to the Committee
on Labor and Human Resources of the Senate, a report describing
programs carried out pursuant to this section. Every 2 years
thereafter, the Director shall prepare a report describing such
programs carried out during the preceding 2 years, and shall
submit the report to the Administrator for inclusion in the
biennial report under section 501(k). Each report under this
subsection shall include a summary of any evaluations conducted
under subsection (m) during the period with respect to which
the report is prepared.
(q) Definitions.--For purposes of this section:
(1) The term ``authorized services'' means
treatment services and supplemental services.
(2) The term ``eligible woman'' means a woman who
has been admitted to a program operated pursuant to
subsection (a).
(3) The term ``funding agreement under subsection
(a)'', with respect to an award under subsection (a),
means that the Director may make the award only if the
applicant makes the agreement involved.
(4) The term ``treatment services'' means treatment
for substance abuse, including the counseling and
services described in subsection (c)(2).
(5) The term ``supplemental services'' means the
services described in subsection (d).
(r) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary to \1\ fiscal years
2001 through 2003.
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\1\ So in law. Probably should be ``for''. See section 3301(a) of
Public Law 106-310 (114 Stat. 1207).
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SEC. 509. [290BB-2] PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority
substance abuse treatment needs of regional and national
significance (as determined under subsection (b)) through the
provision of or through assistance for--
(1) knowledge development and application projects
for treatment and rehabilitation and the conduct or
support of evaluations of such projects;
(2) training and technical assistance; and
(3) targeted capacity response programs.
The Secretary may carry out the activities described in this
section directly or through grants or cooperative agreements
with States, political subdivisions of States, Indian tribes
and tribal organizations, other public or nonprofit private
entities.
(b) Priority Substance Abuse Treatment Needs.--
(1) In general.--Priority substance abuse treatment
needs of regional and national significance shall be
determined by the Secretary after consultation with
States and other interested groups. The Secretary shall
meet with the States and interested groups on an annual
basis to discuss program priorities.
(2) Special consideration.--In developing program
priorities under paragraph (1), the Secretary shall
give special consideration to promoting the integration
of substance abuse treatment services into primary
health care systems.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts,
or cooperative agreements under this section shall
comply with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for
projects carried out under subsection (a), require that
entities that apply for grants, contracts, or
cooperative agreements under that project provide non-
Federal matching funds, as determined appropriate by
the Secretary, to ensure the institutional commitment
of the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract, or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--The Secretary shall
establish comprehensive information and education programs to
disseminate and apply the findings of the knowledge development
and application, training and technical assistance programs,
and targeted capacity response programs under this section to
the general public, to health professionals and other
interested groups. The Secretary shall make every effort to
provide linkages between the findings of supported projects and
State agencies responsible for carrying out substance abuse
prevention and treatment programs.
(f ) Authorization of Appropriation.--There are authorized
to be appropriated to carry out this section, $300,000,000 for
fiscal year 2001 and such sums as may be necessary for each of
the fiscal years 2002 and 2003.
action by national institute on drug abuse and states concerning
military facilities
Sec. 513. \1\ [290bb-6] (a) Center for Substance Abuse
Treatment.--The Director of the Center for Substance Abuse
Treatment shall--
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\1\ Sections 510 through 512 were repealed by section 3301(c) of
Public Law 106-310 (114 Stat. 1209).
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(1) coordinate with the agencies represented on the
Commission on Alternative Utilization of Military
Facilities the utilization of military facilities or
parts thereof, as identified by such Commission,
established under the National Defense Authorization
Act of 1989, that could be utilized or renovated to
house nonviolent persons for drug treatment purposes;
(2) notify State agencies responsible for the
oversight of drug abuse treatment entities and programs
of the availability of space at the installations
identified in paragraph (1); and
(3) assist State agencies responsible for the
oversight of drug abuse treatment entities and programs
in developing methods for adapting the installations
described in paragraph (1) into residential treatment
centers.
(b) States.--With regard to military facilities or parts
thereof, as identified by the Commission on Alternative
Utilization of Military Facilities established under section
3042 of the Comprehensive Alcohol Abuse, Drug Abuse, and Mental
Health Amendments Act of 1988, that could be utilized or
renovated to house nonviolent persons for drug treatment
purposes, State agencies responsible for the oversight of drug
abuse treatment entities and programs shall--
(1) establish eligibility criteria for the
treatment of individuals at such facilities;
(2) select treatment providers to provide drug
abuse treatment at such facilities;
(3) provide assistance to treatment providers
selected under paragraph (2) to assist such providers
in securing financing to fund the cost of the programs
at such facilities; and
(4) establish, regulate, and coordinate with the
military official in charge of the facility, work
programs for individuals receiving treatment at such
facilities.
(c) Reservation of Space.--Prior to notifying States of the
availability of space at military facilities under subsection
(a)(2), the Director may reserve space at such facilities to
conduct research or demonstration projects.
SEC. 514. [290BB-7] SUBSTANCE ABUSE TREATMENT SERVICES FOR CHILDREN AND
ADOLESCENTS.
(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to public and private
nonprofit entities, including Native Alaskan entities and
Indian tribes and tribal organizations, for the purpose of
providing substance abuse treatment services for children and
adolescents.
(b) Priority.--In awarding grants, contracts, or
cooperative agreements under subsection (a), the Secretary
shall give priority to applicants who propose to--
(1) apply evidenced-based and cost effective
methods for the treatment of substance abuse among
children and adolescents;
(2) coordinate the provision of treatment services
with other social service agencies in the community,
including educational, juvenile justice, child welfare,
and mental health agencies;
(3) provide a continuum of integrated treatment
services, including case management, for children and
adolescents with substance abuse disorders and their
families;
(4) provide treatment that is gender-specific and
culturally appropriate;
(5) involve and work with families of children and
adolescents receiving treatment;
(6) provide aftercare services for children and
adolescents and their families after completion of
substance abuse treatment; and
(7) address the relationship between substance
abuse and violence.
(c) Duration of Grants.--The Secretary shall award grants,
contracts, or cooperative agreements under subsection (a) for
periods not to exceed 5 fiscal years.
(d) Application.--An entity desiring a grant, contract, or
cooperative agreement under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
(e) Evaluation.--An entity that receives a grant, contract,
or cooperative agreement under subsection (a) shall submit, in
the application for such grant, contract, or cooperative
agreement, a plan for the evaluation of any project undertaken
with funds provided under this section. Such entity shall
provide the Secretary with periodic evaluations of the progress
of such project and such evaluation at the completion of such
project as the Secretary determines to be appropriate.
(f ) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $40,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 and 2003.
SEC. 514A. [290BB-8] EARLY INTERVENTION SERVICES FOR CHILDREN AND
ADOLESCENTS.
(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to public and private
nonprofit entities, including local educational agencies (as
defined in section 14101 of the Elementary and Secondary
Education Act of 1965 (20 U.S.C. 8801)), for the purpose of
providing early intervention substance abuse services for
children and adolescents.
(b) Priority.--In awarding grants, contracts, or
cooperative agreements under subsection (a), the Secretary
shall give priority to applicants who demonstrate an ability
to--
(1) screen for and assess substance use and abuse
by children and adolescents;
(2) make appropriate referrals for children and
adolescents who are in need of treatment for substance
abuse;
(3) provide early intervention services, including
counseling and ancillary services, that are designed to
meet the developmental needs of children and
adolescents who are at risk for substance abuse; and
(4) develop networks with the educational, juvenile
justice, social services, and other agencies and
organizations in the State or local community involved
that will work to identify children and adolescents who
are in need of substance abuse treatment services.
(c) Condition.--In awarding grants, contracts, or
cooperative agreements under subsection (a), the Secretary
shall ensure that such grants, contracts, or cooperative
agreements are allocated, subject to the availability of
qualified applicants, among the principal geographic regions of
the United States, to Indian tribes and tribal organizations,
and to urban and rural areas.
(d) Duration of Grants.--The Secretary shall award grants,
contracts, or cooperative agreements under subsection (a) for
periods not to exceed 5 fiscal years.
(e) Application.--An entity desiring a grant, contract, or
cooperative agreement under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
(f ) Evaluation.--An entity that receives a grant,
contract, or cooperative agreement under subsection (a) shall
submit, in the application for such grant, contract, or
cooperative agreement, a plan for the evaluation of any project
undertaken with funds provided under this section. Such entity
shall provide the Secretary with periodic evaluations of the
progress of such project and such evaluation at the completion
of such project as the Secretary determines to be appropriate.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $20,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 and 2003.
methamphetamine and amphetamine treatment initiative
Sec. 514. \1\ [290bb-9] (a) Grants.--
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\1\ So in law. There are two sections 514. The first was added at
the end of this subpart (subpart 1 of part B) by section 3104(a) of
Public Law 106-310 (114 Stat. 1171). That section also added section
514A. Section 3632 of such Public Law (114 Stat. 1236) then added at
the end of this subpart section 514 above.
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(1) Authority to make grants.--The Director of the
Center for Substance Abuse Treatment may make grants to
States and Indian tribes recognized by the United
States that have a high rate, or have had a rapid
increase, in methamphetamine or amphetamine abuse or
addiction in order to permit such States and Indian
tribes to expand activities in connection with the
treatment of methamphetamine or amphetamine abuser or
addiction in the specific geographical areas of such
States or Indian tribes, as the case may be, where
there is such a rate or has been such an increase.
(2) Recipients.--Any grants under paragraph (1)
shall be directed to the substance abuse directors of
the States, and of the appropriate tribal government
authorities of the Indian tribes, selected by the
Director to receive such grants.
(3) Nature of activities.--Any activities under a
grant under paragraph (1) shall be based on reliable
scientific evidence of their efficacy in the treatment
of methamphetamine or amphetamine abuse or addiction.
(b) Geographic Distribution.--The Director shall ensure
that grants under subsection (a) are distributed equitably
among the various regions of the country and among rural,
urban, and suburban areas that are affected by methamphetamine
or amphetamine abuse or addiction.
(c) Additional Activities.--The Director shall--
(1) evaluate the activities supported by grants
under subsection (a);
(2) disseminate widely such significant information
derived from the evaluation as the Director considers
appropriate to assist States, Indian tribes, and
private providers of treatment services for
methamphetamine or amphetamine abuser or addiction in
the treatment of methamphetamine or amphetamine abuse
or addiction; and
(3) provide States, Indian tribes, and such
providers with technical assistance in connection with
the provision of such treatment.
(d) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this section $10,000,000 for
fiscal year 2000 and such sums as may be necessary for
each of fiscal years 2001 and 2002.
(2) Use of certain funds.--Of the funds
appropriated to carry out this section in any fiscal
year, the lesser of 5 percent of such funds or
$1,000,000 shall be available to the Director for
purposes of carrying out subsection (c).
Subpart 2--Center for Substance Abuse Prevention
office for substance abuse prevention
Sec. 515. [290bb-21] (a) There is established in the
Administration an Office for Substance Abuse Prevention
(hereafter referred to in this part as the ``Prevention
Center''). The Office \1\ shall be headed by a Director
appointed by the Secretary from individuals with extensive
experience or academic qualifications in the prevention of drug
or alcohol abuse.
---------------------------------------------------------------------------
\1\ So in law. See subsections (a), (d), and (e) of section 113 of
Public Law 102-321 (106 Stat. 345). Probably should be ``Prevention
Center''.
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(b) The Director of the Prevention Center shall--
(1) sponsor regional workshops on the prevention of
drug and alcohol abuse;
(2) coordinate the findings of research sponsored
by agencies of the Service on the prevention of drug
and alcohol abuse;
(3) develop effective drug and alcohol abuse
prevention literature (including literature on the
adverse effects of cocaine free base (known as crack));
(4) in cooperation with the Secretary of Education,
assure the widespread dissemination of prevention
materials among States, political subdivisions, and
school systems;
(5) support clinical training programs for
substance abuse counselors and other health
professionals involved in drug abuse education,
prevention,; \2\
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\2\ So in law. See section 113(c)(1) of Public Law 102-321 (106
Stat. 345).
---------------------------------------------------------------------------
(6) in cooperation with the Director of the Centers
for Disease Control \3\, develop educational materials
to reduce the risks of acquired immune deficiency
syndrome among intravenous drug abusers;
---------------------------------------------------------------------------
\3\ So in law. See section 113(b) of Public Law 102-321 (106 Stat.
345). Probably should be ``Centers for Disease Control and
Prevention''. Section 515 formerly was section 508, and after such
redesignation, section 312(d)(10) of Public Law 102-531 (106 Stat.
3505) attempted to amend ``section 508(b)(6)'' with respect to adding
``and Prevention''.
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(7) conduct training, technical assistance, data
collection, and evaluation activities of programs
supported under the Drug Free Schools and Communities
Act of 1986;
(8) support the development of model, innovative,
community-based programs to discourage alcohol and drug
abuse among young people;
(9) collaborate with the Attorney General of the
Department of Justice to develop programs to prevent
drug abuse among high risk youth;
(10) prepare for distribution documentary films and
public service announcements for television and radio
to educate the public, especially adolescent audiences,
concerning the dangers to health resulting from the
consumption of alcohol and drugs and, to the extent
feasible, use appropriate private organizations and
business concerns in the preparation of such
announcements; and
(11) develop and support innovative demonstration
programs designed to identify and deter the improper
use or abuse of anabolic steroids by students,
especially students in secondary schools.
(c) The Director may make grants and enter into contracts
and cooperative agreements in carrying out subsection (b).
(d) The Director of the Prevention Center shall establish a
national data base providing information on programs for the
prevention of substance abuse. The data base shall contain
information appropriate for use by public entities and
information appropriate for use by nonprofit private entities.
SEC. 516. [290BB-22] PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS OF
REGIONAL AND NATIONAL SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority
substance abuse prevention needs of regional and national
significance (as determined under subsection (b)) through the
provision of or through assistance for--
(1) knowledge development and application projects
for prevention and the conduct or support of
evaluations of such projects;
(2) training and technical assistance; and
(3) targeted capacity response programs.
The Secretary may carry out the activities described in this
section directly or through grants or cooperative agreements
with States, political subdivisions of States, Indian tribes
and tribal organizations, or other public or nonprofit private
entities.
(b) Priority Substance Abuse Prevention Needs.--
(1) In general.--Priority substance abuse
prevention needs of regional and national significance
shall be determined by the Secretary in consultation
with the States and other interested groups. The
Secretary shall meet with the States and interested
groups on an annual basis to discuss program
priorities.
(2) Special consideration.--In developing program
priorities under paragraph (1), the Secretary shall
give special consideration to--
(A) applying the most promising strategies
and research-based primary prevention
approaches; and
(B) promoting the integration of substance
abuse prevention information and activities
into primary health care systems.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts,
and cooperative agreements under this section shall
comply with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for
projects carried out under subsection (a), require that
entities that apply for grants, contracts, or
cooperative agreements under that project provide non-
Federal matching funds, as determined appropriate by
the Secretary, to ensure the institutional commitment
of the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract, or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--The Secretary shall
establish comprehensive information and education programs to
disseminate the findings of the knowledge development and
application, training and technical assistance programs, and
targeted capacity response programs under this section to the
general public and to health professionals. The Secretary shall
make every effort to provide linkages between the findings of
supported projects and State agencies responsible for carrying
out substance abuse prevention and treatment programs.
(f ) Authorization of Appropriation.--There are authorized
to be appropriated to carry out this section, $300,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003.
prevention, treatment, and rehabilitation model projects for high risk
youth
Sec. 517. [290bb-23] (a) The Secretary, through the
Director of the Prevention Center, shall make grants to public
and nonprofit private entities for projects to demonstrate
effective models for the prevention, treatment, and
rehabilitation of drug abuse and alcohol abuse among high risk
youth.
(b)(1) In making grants for drug abuse and alcohol abuse
prevention projects under this section, the Secretary shall
give priority to applications for projects directed at children
of substance abusers, latchkey children, children at risk of
abuse or neglect, preschool children eligible for services
under the Head Start Act, children at risk of dropping out of
school, children at risk of becoming adolescent parents, and
children who do not attend school and who are at risk of being
unemployed.
(2) In making grants for drug abuse and alcohol abuse
treatment and rehabilitation projects under this section, the
Secretary shall give priority to projects which address the
relationship between drug abuse or alcohol abuse and physical
child abuse, sexual child abuse, emotional child abuse,
dropping out of school, unemployment, delinquency, pregnancy,
violence, suicide, or mental health problems.
(3) In making grants under this section, the Secretary
shall give priority to applications from community based
organizations for projects to develop innovative models with
multiple, coordinated services for the prevention or for the
treatment and rehabilitation of drug abuse or alcohol abuse by
high risk youth.
(4) In making grants under this section, the Secretary
shall give priority to applications for projects to demonstrate
effective models with multiple, coordinated services which may
be replicated and which are for the prevention or for the
treatment and rehabilitation of drug abuse or alcohol abuse by
high risk youth.
(5) In making grants under this section, the Secretary
shall give priority to applications that employ research
designs adequate for evaluating the effectiveness of the
program.
(c) The Secretary shall ensure that projects under
subsection (a) include strategies for reducing the use of
alcoholic beverages and tobacco products by individuals to whom
it is unlawful to sell or distribute such beverages or
products.
(d) To the extent feasible, the Secretary shall make
grants under this section in all regions of the United States,
and shall ensure the distribution of grants under this section
among urban and rural areas.
(e) In order to receive a grant for a project under this
section for a fiscal year, a public or nonprofit private entity
shall submit an application to the Secretary, acting through
the Office. The Secretary may provide to the Governor of the
State the opportunity to review and comment on such
application. Such application shall be in such form, shall
contain such information, and shall be submitted at such time
as the Secretary may by regulation prescribe.
(f) The Director \1\ of the Office shall evaluate
projects conducted with grants under this section.
---------------------------------------------------------------------------
\1\ So in law. See section 114, and subsections (a), (d), and (e)
of section 113, of Public Law 102-321 (106 Stat. 346, 345). Probably
should be ``Prevention Center''.
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(g) For purposes of this section, the term ``high risk
youth'' means an individual who has not attained the age of 21
years, who is at high risk of becoming, or who has become, a
drug abuser or an alcohol abuser, and who--
(1) is identified as a child of a substance abuser;
(2) is a victim of physical, sexual, or
psychological abuse;
(3) has dropped out of school;
(4) has become pregnant;
(5) is economically disadvantaged;
(6) has committed a violent or delinquent act;
(7) has experienced mental health problems;
(8) has attempted suicide;
(9) has experienced long-term physical pain due to
injury; or
(10) has experienced chronic failure in school.
(h) For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2001 through 2003.
SEC. 519A. \1\ [290BB-25A] GRANTS FOR STRENGTHENING FAMILIES.
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\1\ The probable intent of the Congress is that section 399A of
this Act appear before section 519A as a section 519. See footnote for
section 399A. (Section 399A relates to grants for services for children
of substance abusers.)
Section 518 was repealed by section 3202(b) of Public Law 106-310
(114 Stat. 1210).
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(a) Program Authorized.--The Secretary, acting through the
Director of the Prevention Center, may make grants to public
and nonprofit private entities to develop and implement model
substance abuse prevention programs to provide early
intervention and substance abuse prevention services for
individuals of high-risk families and the communities in which
such individuals reside.
(b) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to applicants that--
(1) have proven experience in preventing substance
abuse by individuals of high-risk families and reducing
substance abuse in communities of such individuals;
(2) have demonstrated the capacity to implement
community-based partnership initiatives that are
sensitive to the diverse backgrounds of individuals of
high-risk families and the communities of such
individuals;
(3) have experience in providing technical
assistance to support substance abuse prevention
programs that are community-based;
(4) have demonstrated the capacity to implement
research-based substance abuse prevention strategies;
and
(5) have implemented programs that involve
families, residents, community agencies, and
institutions in the implementation and design of such
programs.
(c) Duration of Grants.--The Secretary shall award grants
under subsection (a) for a period not to exceed 5 years.
(d) Use of Funds.--An applicant that is awarded a grant
under subsection (a) shall--
(1) in the first fiscal year that such funds are
received under the grant, use such funds to develop a
model substance abuse prevention program; and
(2) in the fiscal year following the first fiscal
year that such funds are received, use such funds to
implement the program developed under paragraph (1) to
provide early intervention and substance abuse
prevention services to--
(A) strengthen the environment of children
of high risk families by targeting
interventions at the families of such children
and the communities in which such children
reside;
(B) strengthen protective factors, such
as--
(i) positive adult role models;
(ii) messages that oppose substance
abuse;
(iii) community actions designed to
reduce accessibility to and use of
illegal substances; and
(iv) willingness of individuals of
families in which substance abuse
occurs to seek treatment for substance
abuse;
(C) reduce family and community risks, such
as family violence, alcohol or drug abuse,
crime, and other behaviors that may effect
healthy child development and increase the
likelihood of substance abuse; and
(D) build collaborative and formal
partnerships between community agencies,
institutions, and businesses to ensure that
comprehensive high quality services are
provided, such as early childhood education,
health care, family support programs, parent
education programs, and home visits for
infants.
(e) Application.--To be eligible to receive a grant under
subsection (a), an applicant shall prepare and submit to the
Secretary an application that--
(1) describes a model substance abuse prevention
program that such applicant will establish;
(2) describes the manner in which the services
described in subsection (d)(2) will be provided; and
(3) describe in as much detail as possible the
results that the entity expects to achieve in
implementing such a program.
(f ) Matching Funding.--The Secretary may not make a grant
to a entity under subsection (a) unless that entity agrees
that, with respect to the costs to be incurred by the entity in
carrying out the program for which the grant was awarded, the
entity will make available non-Federal contributions in an
amount that is not less than 40 percent of the amount provided
under the grant.
(g) Report to Secretary.--An applicant that is awarded a
grant under subsection (a) shall prepare and submit to the
Secretary a report in such form and containing such information
as the Secretary may require, including an assessment of the
efficacy of the model substance abuse prevention program
implemented by the applicant and the short, intermediate, and
long term results of such program.
(h) Evaluations.--The Secretary shall conduct evaluations,
based in part on the reports submitted under subsection (g), to
determine the effectiveness of the programs funded under
subsection (a) in reducing substance use in high-risk families
and in making communities in which such families reside in
stronger. The Secretary shall submit such evaluations to the
appropriate committees of Congress.
(i) High-Risk Families.--In this section, the term ``high-
risk family'' means a family in which the individuals of such
family are at a significant risk of using or abusing alcohol or
any illegal substance.
( j) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $3,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
the fiscal years 2002 and 2003.
SEC. 519B. [290BB-25B] PROGRAMS TO REDUCE UNDERAGE DRINKING.
(a) Definitions.--For purposes of this section:
(1) The term ``alcohol beverage industry'' means
the brewers, vintners, distillers, importers,
distributors, and retail or online outlets that sell or
serve beer, wine, and distilled spirits.
(2) The term ``school-based prevention'' means
programs, which are institutionalized, and run by staff
members or school-designated persons or organizations
in any grade of school, kindergarten through 12th
grade.
(3) The term ``youth'' means persons under the age
of 21.
(4) The term ``IOM report'' means the report
released in September 2003 by the National Research
Council, Institute of Medicine, and entitled ``Reducing
Underage Drinking: A Collective Responsibility''.
(b) Sense of Congress.--It is the sense of the Congress
that:
(1) A multi-faceted effort is needed to more
successfully address the problem of underage drinking
in the United States. A coordinated approach to
prevention, intervention, treatment, enforcement, and
research is key to making progress. This Act recognizes
the need for a focused national effort, and addresses
particulars of the Federal portion of that effort, as
well as Federal support for State activities.
(2) The Secretary of Health and Human Services
shall continue to conduct research and collect data on
the short and long-range impact of alcohol use and
abuse upon adolescent brain development and other organ
systems.
(3) States and communities, including colleges and
universities, are encouraged to adopt comprehensive
prevention approaches, including--
(A) evidence-based screening, programs and
curricula;
(B) brief intervention strategies;
(C) consistent policy enforcement; and
(D) environmental changes that limit
underage access to alcohol.
(4) Public health groups, consumer groups, and the
alcohol beverage industry should continue and expand
evidence-based efforts to prevent and reduce underage
drinking.
(5) The entertainment industries have a powerful
impact on youth, and they should use rating systems and
marketing codes to reduce the likelihood that underage
audiences will be exposed to movies, recordings, or
television programs with unsuitable alcohol content.
(6) The National Collegiate Athletic Association,
its member colleges and universities, and athletic
conferences should affirm a commitment to a policy of
discouraging alcohol use among underage students and
other young fans.
(7) Alcohol is a unique product and should be
regulated differently than other products by the States
and Federal Government. States have primary authority
to regulate alcohol distribution and sale, and the
Federal Government should support and supplement these
State efforts. States also have a responsibility to
fight youth access to alcohol and reduce underage
drinking. Continued State regulation and licensing of
the manufacture, importation, sale, distribution,
transportation and storage of alcoholic beverages are
clearly in the public interest and are critical to
promoting responsible consumption, preventing illegal
access to alcohol by persons under 21 years of age from
commercial and non-commercial sources, maintaining
industry integrity and an orderly marketplace, and
furthering effective State tax collection.
(c) Interagency Coordinating Committee; Annual Report on
State Underage Drinking Prevention and Enforcement
Activities.--
(1) Interagency coordinating committee on the
prevention of underage drinking.--
(A) In general.--The Secretary, in
collaboration with the Federal officials
specified in subparagraph (B), shall formally
establish and enhance the efforts of the
interagency coordinating committee, that began
operating in 2004, focusing on underage
drinking (referred to in this subsection as the
``Committee'').
(B) Other agencies.--The officials referred
to in paragraph (1) are the Secretary of
Education, the Attorney General, the Secretary
of Transportation, the Secretary of the
Treasury, the Secretary of Defense, the Surgeon
General, the Director of the Centers for
Disease Control and Prevention, the Director of
the National Institute on Alcohol Abuse and
Alcoholism, the Administrator of the Substance
Abuse and Mental Health Services
Administration, the Director of the National
Institute on Drug Abuse, the Assistant
Secretary for Children and Families, the
Director of the Office of National Drug Control
Policy, the Administrator of the National
Highway Traffic Safety Administration, the
Administrator of the Office of Juvenile Justice
and Delinquency Prevention, the Chairman of the
Federal Trade Commission, and such other
Federal officials as the Secretary of Health
and Human Services determines to be
appropriate.
(C) Chair.--The Secretary of Health and
Human Services shall serve as the chair of the
Committee.
(D) Duties.--The Committee shall guide
policy and program development across the
Federal Government with respect to underage
drinking, provided, however, that nothing in
this section shall be construed as transferring
regulatory or program authority from an Agency
to the Coordinating Committee.
(E) Consultations.--The Committee shall
actively seek the input of and shall consult
with all appropriate and interested parties,
including States, public health research and
interest groups, foundations, and alcohol
beverage industry trade associations and
companies.
(F) Annual report.--
(i) In general.--The Secretary, on
behalf of the Committee, shall annually
submit to the Congress a report that
summarizes--
(I) all programs and
policies of Federal agencies
designed to prevent and reduce
underage drinking;
(II) the extent of progress
in preventing and reducing
underage drinking nationally;
(III) data that the
Secretary shall collect with
respect to the information
specified in clause (ii); and
(IV) such other information
regarding underage drinking as
the Secretary determines to be
appropriate.
(ii) Certain information.--The
report under clause (i) shall include
information on the following:
(I) Patterns and
consequences of underage
drinking as reported in
research and surveys such as,
but not limited to Monitoring
the Future, Youth Risk Behavior
Surveillance System, the
National Survey on Drug Use and
Health, and the Fatality
Analysis Reporting System.
(II) Measures of the
availability of alcohol from
commercial and non-commercial
sources to underage
populations.
(III) Measures of the
exposure of underage
populations to messages
regarding alcohol in
advertising and the
entertainment media as reported
by the Federal Trade
Commission.
(IV) Surveillance data,
including information on the
onset and prevalence of
underage drinking, consumption
patterns and the means of
underage access. The Secretary
shall develop a plan to improve
the collection, measurement and
consistency of reporting
Federal underage alcohol data.
(V) Any additional findings
resulting from research
conducted or supported under
subsection (f).
(VI) Evidence-based best
practices to prevent and reduce
underage drinking and provide
treatment services to those
youth who need them.
(2) Annual report on state underage drinking
prevention and enforcement activities.--
(A) In general.--The Secretary shall, with
input and collaboration from other appropriate
Federal agencies, States, Indian tribes,
territories, and public health, consumer, and
alcohol beverage industry groups, annually
issue a report on each State's performance in
enacting, enforcing, and creating laws,
regulations, and programs to prevent or reduce
underage drinking.
(B) State performance measures.--
(i) In general.--The Secretary
shall develop, in consultation with the
Committee, a set of measures to be used
in preparing the report on best
practices.
(ii) Categories.--In developing
these measures, the Secretary shall
consider categories including, but not
limited to:
(I) Whether or not the
State has comprehensive anti-
underage drinking laws such as
for the illegal sale, purchase,
attempt to purchase,
consumption, or possession of
alcohol; illegal use of
fraudulent ID; illegal
furnishing or obtaining of
alcohol for an individual under
21 years; the degree of
strictness of the penalties for
such offenses; and the
prevalence of the enforcement
of each of these infractions.
(II) Whether or not the
State has comprehensive
liability statutes pertaining
to underage access to alcohol
such as dram shop, social host,
and house party laws, and the
prevalence of enforcement of
each of these laws.
(III) Whether or not the
State encourages and conducts
comprehensive enforcement
efforts to prevent underage
access to alcohol at retail
outlets, such as random
compliance checks and shoulder
tap programs, and the number of
compliance checks within
alcohol retail outlets measured
against the number of total
alcohol retail outlets in each
State, and the result of such
checks.
(IV) Whether or not the
State encourages training on
the proper selling and serving
of alcohol for all sellers and
servers of alcohol as a
condition of employment.
(V) Whether or not the
State has policies and
regulations with regard to
direct sales to consumers and
home delivery of alcoholic
beverages.
(VI) Whether or not the
State has programs or laws to
deter adults from purchasing
alcohol for minors; and the
number of adults targeted by
these programs.
(VII) Whether or not the
State has programs targeted to
youths, parents, and caregivers
to deter underage drinking; and
the number of individuals
served by these programs.
(VIII) Whether or not the
State has enacted graduated
drivers licenses and the extent
of those provisions.
(IX) The amount that the
State invests, per youth
capita, on the prevention of
underage drinking, further
broken down by the amount spent
on--
(aa) compliance
check programs in
retail outlets,
including providing
technology to prevent
and detect the use of
false identification by
minors to make alcohol
purchases;
(bb) checkpoints
and saturation patrols
that include the goal
of reducing and
deterring underage
drinking;
(cc) community-
based, school-based,
and higher-education-
based programs to
prevent underage
drinking;
(dd) underage
drinking prevention
programs that target
youth within the
juvenile justice and
child welfare systems;
and
(ee) other State
efforts or programs as
deemed appropriate.
(3) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection $1,000,000 for fiscal year 2007, and
$1,000,000 for each of the fiscal years 2008 through
2010.
(d) National Media Campaign To Prevent Underage Drinking.--
(1) Scope of the campaign.--The Secretary shall
continue to fund and oversee the production,
broadcasting, and evaluation of the national adult-
oriented media public service campaign if the Secretary
determines that such campaign is effective in achieving
the media campaign's measurable objectives.
(2) Report.--The Secretary shall provide a report
to the Congress annually detailing the production,
broadcasting, and evaluation of the campaign referred
to in paragraph (1), and to detail in the report the
effectiveness of the campaign in reducing underage
drinking, the need for and likely effectiveness of an
expanded adult-oriented media campaign, and the
feasibility and the likely effectiveness of a national
youth-focused media campaign to combat underage
drinking.
(3) Consultation requirement.--In carrying out the
media campaign, the Secretary shall direct the entity
carrying out the national adult-oriented media public
service campaign to consult with interested parties
including both the alcohol beverage industry and public
health and consumer groups. The progress of this
consultative process is to be covered in the report
under paragraph (2).
(4) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection, $1,000,000 for fiscal year 2007 and
$1,000,000 for each of the fiscal years 2008 through
2010.
(e) Interventions.--
(1) Community-based coalition enhancement grants to
prevent underage drinking.--
(A) Authorization of program.--The
Administrator of the Substance Abuse and Mental
Health Services Administration, in consultation
with the Director of the Office of National
Drug Control Policy, shall award, if the
Administrator determines that the Department of
Health and Human Services is not currently
conducting activities that duplicate activities
of the type described in this subsection,
``enhancement grants'' to eligible entities to
design, test, evaluate and disseminate
effective strategies to maximize the
effectiveness of community-wide approaches to
preventing and reducing underage drinking. This
subsection is subject to the availability of
appropriations.
(B) Purposes.--The purposes of this
paragraph are to--
(i) prevent and reduce alcohol use
among youth in communities throughout
the United States;
(ii) strengthen collaboration among
communities, the Federal Government,
and State, local, and tribal
governments;
(iii) enhance intergovernmental
cooperation and coordination on the
issue of alcohol use among youth;
(iv) serve as a catalyst for
increased citizen participation and
greater collaboration among all sectors
and organizations of a community that
first demonstrates a long-term
commitment to reducing alcohol use
among youth;
(v) disseminate to communities
timely information regarding state-of-
the-art practices and initiatives that
have proven to be effective in
preventing and reducing alcohol use
among youth; and
(vi) enhance, not supplant,
effective local community initiatives
for preventing and reducing alcohol use
among youth.
(C) Application.--An eligible entity
desiring an enhancement grant under this
paragraph shall submit an application to the
Administrator at such time, and in such manner,
and accompanied by such information as the
Administrator may require. Each application
shall include--
(i) a complete description of the
entity's current underage alcohol use
prevention initiatives and how the
grant will appropriately enhance the
focus on underage drinking issues; or
(ii) a complete description of the
entity's current initiatives, and how
it will use this grant to enhance those
initiatives by adding a focus on
underage drinking prevention.
(D) Uses of funds.--Each eligible entity
that receives a grant under this paragraph
shall use the grant funds to carry out the
activities described in such entity's
application submitted pursuant to subparagraph
(C). Grants under this paragraph shall not
exceed $50,000 per year and may not exceed four
years.
(E) Supplement not supplant.--Grant funds
provided under this paragraph shall be used to
supplement, not supplant, Federal and non-
Federal funds available for carrying out the
activities described in this paragraph.
(F) Evaluation.--Grants under this
paragraph shall be subject to the same
evaluation requirements and procedures as the
evaluation requirements and procedures imposed
on recipients of drug free community grants.
(G) Definitions.--For purposes of this
paragraph, the term ``eligible entity'' means
an organization that is currently receiving or
has received grant funds under the Drug-Free
Communities Act of 1997 (21 U.S.C. 1521 et
seq.).
(H) Administrative expenses.--Not more than
6 percent of a grant under this paragraph may
be expended for administrative expenses.
(I) Authorization of appropriations.--There
are authorized to be appropriated to carry out
this paragraph $5,000,000 for fiscal year 2007,
and $5,000,000 for each of the fiscal years
2008 through 2010.
(2) Grants directed at preventing and reducing
alcohol abuse at institutions of higher education.--
(A) Authorization of program.--The
Secretary shall award grants to eligible
entities to enable the entities to prevent and
reduce the rate of underage alcohol consumption
including binge drinking among students at
institutions of higher education.
(B) Applications.--An eligible entity that
desires to receive a grant under this paragraph
shall submit an application to the Secretary at
such time, in such manner, and accompanied by
such information as the Secretary may require.
Each application shall include--
(i) a description of how the
eligible entity will work to enhance an
existing, or where none exists to build
a, statewide coalition;
(ii) a description of how the
eligible entity will target underage
students in the State;
(iii) a description of how the
eligible entity intends to ensure that
the statewide coalition is actually
implementing the purpose of this
section and moving toward indicators
described in subparagraph (D);
(iv) a list of the members of the
statewide coalition or interested
parties involved in the work of the
eligible entity;
(v) a description of how the
eligible entity intends to work with
State agencies on substance abuse
prevention and education;
(vi) the anticipated impact of
funds provided under this paragraph in
preventing and reducing the rates of
underage alcohol use;
(vii) outreach strategies,
including ways in which the eligible
entity proposes to--
(I) reach out to students
and community stakeholders;
(II) promote the purpose of
this paragraph;
(III) address the range of
needs of the students and the
surrounding communities; and
(IV) address community
norms for underage students
regarding alcohol use; and
(viii) such additional information
as required by the Secretary.
(C) Uses of funds.--Each eligible entity
that receives a grant under this paragraph
shall use the grant funds to carry out the
activities described in such entity's
application submitted pursuant to subparagraph
(B).
(D) Accountability.--On the date on which
the Secretary first publishes a notice in the
Federal Register soliciting applications for
grants under this paragraph, the Secretary
shall include in the notice achievement
indicators for the program authorized under
this paragraph. The achievement indicators
shall be designed--
(i) to measure the impact that the
statewide coalitions assisted under
this paragraph are having on the
institutions of higher education and
the surrounding communities, including
changes in the number of incidents of
any kind in which students have abused
alcohol or consumed alcohol while under
the age of 21 (including violations,
physical assaults, sexual assaults,
reports of intimidation, disruptions of
school functions, disruptions of
student studies, mental health
referrals, illnesses, or deaths);
(ii) to measure the quality and
accessibility of the programs or
information offered by the eligible
entity; and
(iii) to provide such other
measures of program impact as the
Secretary determines appropriate.
(E) Supplement not supplant.--Grant funds
provided under this paragraph shall be used to
supplement, and not supplant, Federal and non-
Federal funds available for carrying out the
activities described in this paragraph.
(F) Definitions.--For purposes of this
paragraph:
(i) Eligible entity.--The term
``eligible entity'' means a State,
institution of higher education, or
nonprofit entity.
(ii) Institution of higher
education.--The term ``institution of
higher education'' has the meaning
given the term in section 101(a) of the
Higher Education Act of 1965 (20 U.S.C.
1001(a)).
(iii) Secretary.--The term
``Secretary'' means the Secretary of
Education.
(iv) State.--The term ``State''
means each of the 50 States, the
District of Columbia, and the
Commonwealth of Puerto Rico.
(v) Statewide coalition.--The term
``statewide coalition'' means a
coalition that--
(I) includes, but is not
limited to--
(aa) institutions
of higher education
within a State; and
(bb) a nonprofit
group, a community
underage drinking
prevention coalition,
or another substance
abuse prevention group
within a State; and
(II) works toward lowering
the alcohol abuse rate by
targeting underage students at
institutions of higher
education throughout the State
and in the surrounding
communities.
(vi) Surrounding community.--The
term ``surrounding community'' means
the community--
(I) that surrounds an
institution of higher education
participating in a statewide
coalition;
(II) where the students
from the institution of higher
education take part in the
community; and
(III) where students from
the institution of higher
education live in off-campus
housing.
(G) Administrative expenses.--Not more than
5 percent of a grant under this paragraph may
be expended for administrative expenses.
(H) Authorization of appropriations.--There
are authorized to be appropriated to carry out
this paragraph $5,000,000 for fiscal year 2007,
and $5,000,000 for each of the fiscal years
2008 through 2010.
(f) Additional Research.--
(1) Additional research on underage drinking.--
(A) In general.--The Secretary shall,
subject to the availability of appropriations,
collect data, and conduct or support research
that is not duplicative of research currently
being conducted or supported by the Department
of Health and Human Services, on underage
drinking, with respect to the following:
(i) Comprehensive community-based
programs or strategies and statewide
systems to prevent and reduce underage
drinking, across the underage years
from early childhood to age 21,
including programs funded and
implemented by government entities,
public health interest groups and
foundations, and alcohol beverage
companies and trade associations.
(ii) Annually obtain and report
more precise information than is
currently collected on the scope of the
underage drinking problem and patterns
of underage alcohol consumption,
including improved knowledge about the
problem and progress in preventing,
reducing and treating underage
drinking; as well as information on the
rate of exposure of youth to
advertising and other media messages
encouraging and discouraging alcohol
consumption.
(iii) Compiling information on the
involvement of alcohol in unnatural
deaths of persons ages 12 to 20 in the
United States, including suicides,
homicides, and unintentional injuries
such as falls, drownings, burns,
poisonings, and motor vehicle crash
deaths.
(B) Certain matters.--The Secretary shall
carry out activities toward the following
objectives with respect to underage drinking:
(i) Obtaining new epidemiological
data within the national or targeted
surveys that identify alcohol use and
attitudes about alcohol use during pre-
and early adolescence, including harm
caused to self or others as a result of
adolescent alcohol use such as
violence, date rape, risky sexual
behavior, and prenatal alcohol
exposure.
(ii) Developing or identifying
successful clinical treatments for
youth with alcohol problems.
(C) Peer review.--Research under
subparagraph (A) shall meet current Federal
standards for scientific peer review.
(2) Authorization of appropriations.--There are
authorized to be appropriated to carry out this
subsection $6,000,000 for fiscal year 2007, and
$6,000,000 for each of the fiscal years 2008 through
2010.
SEC. 519C. [290BB-25C] SERVICES FOR INDIVIDUALS WITH FETAL ALCOHOL
SYNDROME.
(a) In General.--The Secretary shall make awards of grants,
cooperative agreements, or contracts to public and nonprofit
private entities, including Indian tribes and tribal
organizations, to provide services to individuals diagnosed
with fetal alcohol syndrome or alcohol-related birth defects.
(b) Use of Funds.--An award under subsection (a) may,
subject to subsection (d), be used to--
(1) screen and test individuals to determine the
type and level of services needed;
(2) develop a comprehensive plan for providing
services to the individual;
(3) provide mental health counseling;
(4) provide substance abuse prevention services and
treatment, if needed;
(5) coordinate services with other social programs
including social services, justice system, educational
services, health services, mental health and substance
abuse services, financial assistance programs,
vocational services and housing assistance programs;
(6) provide vocational services;
(7) provide health counseling;
(8) provide housing assistance;
(9) parenting skills training;
(10) overall case management;
(11) supportive services for families of
individuals with Fetal Alcohol Syndrome; and
(12) provide other services and programs, to the
extent authorized by the Secretary after consideration
of recommendations made by the National Task Force on
Fetal Alcohol Syndrome.
(c) Requirements.--To be eligible to receive an award under
subsection (a), an applicant shall--
(1) demonstrate that the program will be part of a
coordinated, comprehensive system of care for such
individuals;
(2) demonstrate an established communication with
other social programs in the community including social
services, justice system, financial assistance
programs, health services, educational services, mental
health and substance abuse services, vocational
services and housing assistance services;
(3) show a history of working with individuals with
fetal alcohol syndrome or alcohol-related birth
defects;
(4) provide assurance that the services will be
provided in a culturally and linguistically appropriate
manner; and
(5) provide assurance that at the end of the 5-year
award period, other mechanisms will be identified to
meet the needs of the individuals and families served
under such award.
(d) Relationship to Payments Under Other Programs.--An
award may be made under subsection (a) only if the applicant
involved agrees that the award will not be expended to pay the
expenses of providing any service under this section to an
individual to the extent that payment has been made, or can
reasonably be expected to be made, with respect to such
expenses--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(2) by an entity that provides health services on a
prepaid basis.
(e) Duration of Awards.--With respect to an award under
subsection (a), the period during which payments under such
award are made to the recipient may not exceed 5 years.
(f ) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(g) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out this section, there are
authorized to be appropriated $25,000,000 for fiscal
year 2001, and such sums as may be necessary for each
of the fiscal years 2002 and 2003.
(2) Allocation.--Of the amounts appropriated under
paragraph (1) for a fiscal year, not less than $300,000
shall, for purposes relating to fetal alcohol syndrome
and alcohol-related birth defects, be made available
for collaborative, coordinated interagency efforts with
the National Institute on Alcohol Abuse and Alcoholism,
the Eunice Kennedy Shriver National Institute of Child
Health and Human Development, the Health Resources and
Services Administration, the Agency for Healthcare
Research and Quality, the Centers for Disease Control
and Prevention, the Department of Education, and the
Department of Justice.
SEC. 519D. [290BB-25D] CENTERS OF EXCELLENCE ON SERVICES FOR
INDIVIDUALS WITH FETAL ALCOHOL SYNDROME AND
ALCOHOL-RELATED BIRTH DEFECTS AND TREATMENT FOR
INDIVIDUALS WITH SUCH CONDITIONS AND THEIR
FAMILIES.
(a) In General.--The Secretary shall make awards of grants,
cooperative agreements, or contracts to public or nonprofit
private entities for the purposes of establishing not more than
four centers of excellence to study techniques for the
prevention of fetal alcohol syndrome and alcohol-related birth
defects and adaptations of innovative clinical interventions
and service delivery improvements for the provision of
comprehensive services to individuals with fetal alcohol
syndrome or alcohol-related birth defects and their families
and for providing training on such conditions.
(b) Use of Funds.--An award under subsection (a) may be
used to--
(1) study adaptations of innovative clinical
interventions and service delivery improvements
strategies for children and adults with fetal alcohol
syndrome or alcohol-related birth defects and their
families;
(2) identify communities which have an exemplary
comprehensive system of care for such individuals so
that they can provide technical assistance to other
communities attempting to set up such a system of care;
(3) provide technical assistance to communities who
do not have a comprehensive system of care for such
individuals and their families;
(4) train community leaders, mental health and
substance abuse professionals, families, law
enforcement personnel, judges, health professionals,
persons working in financial assistance programs,
social service personnel, child welfare professionals,
and other service providers on the implications of
fetal alcohol syndrome and alcohol-related birth
defects, the early identification of and referral for
such conditions;
(5) develop innovative techniques for preventing
alcohol use by women in child bearing years; \1\
---------------------------------------------------------------------------
\1\So in law. Probably should read ``; and''. See section 3110 of
Public Law 106-310 (114 Stat. 1185).
---------------------------------------------------------------------------
(6) perform other functions, to the extent
authorized by the Secretary after consideration of
recommendations made by the National Task Force on
Fetal Alcohol Syndrome.
(c) Report.--
(1) In general.--A recipient of an award under
subsection (a) shall at the end of the period of
funding report to the Secretary on any innovative
techniques that have been discovered for preventing
alcohol use among women of child bearing years.
(2) Dissemination of findings.--The Secretary shall
upon receiving a report under paragraph (1) disseminate
the findings to appropriate public and private
entities.
(d) Duration of Awards.--With respect to an award under
subsection (a), the period during which payments under such
award are made to the recipient may not exceed 5 years.
(e) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(f ) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2001, and such sums as
may be necessary for each of the fiscal years 2002 and 2003.
SEC. 519E. \1\ [290BB-25E] PREVENTION OF METHAMPHETAMINE AND INHALANT
ABUSE AND ADDICTION.
---------------------------------------------------------------------------
\1\ The placement of section 519E is according to the probable
intent of the Congress. Section 3104(c) of Public Law 106-310 (114
Stat. 1173) added the section to this subpart, but did not specify the
specific placement of the section.
---------------------------------------------------------------------------
(a) Grants.--The Director of the Center for Substance Abuse
Prevention (referred to in this section as the ``Director'')
may make grants to and enter into contracts and cooperative
agreements with public and nonprofit private entities to enable
such entities--
(1) to carry out school-based programs concerning
the dangers of methamphetamine or inhalant abuse and
addiction, using methods that are effective and
evidence-based, including initiatives that give
students the responsibility to create their own anti-
drug abuse education programs for their schools; and
(2) to carry out community-based methamphetamine or
inhalant abuse and addiction prevention programs that
are effective and evidence-based.
(b) Use of Funds.--Amounts made available under a grant,
contract or cooperative agreement under subsection (a) shall be
used for planning, establishing, or administering
methamphetamine or inhalant prevention programs in accordance
with subsection (c).
(c) Prevention Programs and Activities.--
(1) In general.--Amounts provided under this
section may be used--
(A) to carry out school-based programs that
are focused on those districts with high or
increasing rates of methamphetamine or inhalant
abuse and addiction and targeted at populations
which are most at risk to start methamphetamine
or inhalant abuse;
(B) to carry out community-based prevention
programs that are focused on those populations
within the community that are most at-risk for
methamphetamine or inhalant abuse and
addiction;
(C) to assist local government entities to
conduct appropriate methamphetamine or inhalant
prevention activities;
(D) to train and educate State and local
law enforcement officials, prevention and
education officials, members of community anti-
drug coalitions and parents on the signs of
methamphetamine or inhalant abuse and addiction
and the options for treatment and prevention;
(E) for planning, administration, and
educational activities related to the
prevention of methamphetamine or inhalant abuse
and addiction;
(F) for the monitoring and evaluation of
methamphetamine or inhalant prevention
activities, and reporting and disseminating
resulting information to the public; and
(G) for targeted pilot programs with
evaluation components to encourage innovation
and experimentation with new methodologies.
(2) Priority.--The Director shall give priority in
making grants under this section to rural and urban
areas that are experiencing a high rate or rapid
increases in methamphetamine or inhalant abuse and
addiction.
(d) Analyses and Evaluation.--
(1) In general.--Up to $500,000 of the amount
available in each fiscal year to carry out this section
shall be made available to the Director, acting in
consultation with other Federal agencies, to support
and conduct periodic analyses and evaluations of
effective prevention programs for methamphetamine or
inhalant abuse and addiction and the development of
appropriate strategies for disseminating information
about and implementing these programs.
(2) Annual reports.--The Director shall submit to
the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate and
the Committee on Commerce and Committee on
Appropriations of the House of Representatives, an
annual report with the results of the analyses and
evaluation under paragraph (1).
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out subsection (a), $10,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 and 2003.
Subpart 3--Center for Mental Health Services
center for mental health services
Sec. 520. [290bb-31] (a) Establishment.--There is
established in the Administration a Center for Mental Health
Services (hereafter in this section referred to as the
``Center''). The Center shall be headed by a Director
(hereafter in this section referred to as the ``Director'')
appointed by the Secretary from among individuals with
extensive experience or academic qualifications in the
provision of mental health services or in the evaluation of
mental health service systems.
(b) Duties.--The Director of the Center shall--
(1) design national goals and establish national
priorities for--
(A) the prevention of mental illness; and
(B) the promotion of mental health;
(2) encourage and assist local entities and State
agencies to achieve the goals and priorities described
in paragraph (1);
(3) collaborate with the Department of Education
and the Department of Justice to develop programs to
assist local communities in addressing violence among
children and adolescents;
(4) develop and coordinate Federal prevention
policies and programs and to assure increased focus on
the prevention of mental illness and the promotion of
mental health;
(5) develop improved methods of treating
individuals with mental health problems and improved
methods of assisting the families of such individuals;
(6) administer the mental health services block
grant program authorized in section 1911;
(7) promote policies and programs at Federal,
State, and local levels and in the private sector that
foster independence and protect the legal rights of
persons with mental illness, including carrying out the
provisions of the Protection and Advocacy of Mentally
Ill Individuals Act;
(8) carry out the programs under part C;
(9) carry out responsibilities for the Human
Resource Development program, and programs of clinical
training for professional and paraprofessional
personnel pursuant to section 303 \1\;
---------------------------------------------------------------------------
\1\ The probable intent of the Congress is that the paragraph read
``(9) carry out responsibilities for the Human Resource Development
Program;''. See section 3112(c)(4) of Public Law 106-310 (114 Stat.
1188), which provides that paragraph (9) is amended ``by striking
`program and programs' and all that follows through `303' and inserting
`programs' ''. The amendment cannot be executed because the term to be
struck does not appear in paragraph (9). (Compare ``program and
programs'' and ``program, and programs''.)
---------------------------------------------------------------------------
(10) conduct services-related assessments,
including evaluations of the organization and financing
of care, self-help and consumer-run programs, mental
health economics, mental health service systems, rural
mental health, and improve the capacity of State to
conduct evaluations of publicly funded mental health
programs;
(11) establish a clearinghouse for mental health
information to assure the widespread dissemination of
such information to States, political subdivisions,
educational agencies and institutions, treatment and
prevention service providers, and the general public,
including information concerning the practical
application of research supported by the National
Institute of Mental Health that is applicable to
improving the delivery of services;
(12) provide technical assistance to public and
private entities that are providers of mental health
services;
(13) monitor and enforce obligations incurred by
community mental health centers pursuant to the
Community Mental Health Centers Act (as in effect prior
to the repeal of such Act on August 13, 1981, by
section 902(e)(2)(B) of Public Law 97-35 (95 Stat.
560));
(14) conduct surveys with respect to mental health,
such as the National Reporting Program; and
(15) assist States in improving their mental health
data collection.
(c) Grants and Contracts.--In carrying out the duties
established in subsection (b), the Director may make grants to
and enter into contracts and cooperative agreements with public
and nonprofit private entities.
SEC. 520A. [290BB-32] PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND
NATIONAL SIGNIFICANCE.
(a) Projects.--The Secretary shall address priority mental
health needs of regional and national significance (as
determined under subsection (b)) through the provision of or
through assistance for--
(1) knowledge development and application projects
for prevention, treatment, and rehabilitation, and the
conduct or support of evaluations of such projects;
(2) training and technical assistance programs;
(3) targeted capacity response programs; and
(4) systems change grants including statewide
family network grants and client-oriented and consumer
run self-help activities.
The Secretary may carry out the activities described in this
subsection directly or through grants or cooperative agreements
with States, political subdivisions of States, Indian tribes
and tribal organizations, other public or private nonprofit
entities.
(b) Priority Mental Health Needs.--
(1) Determination of needs.--Priority mental health
needs of regional and national significance shall be
determined by the Secretary in consultation with States
and other interested groups. The Secretary shall meet
with the States and interested groups on an annual
basis to discuss program priorities.
(2) Special consideration.--In developing program
priorities described in paragraph (1), the Secretary
shall give special consideration to promoting the
integration of mental health services into primary
health care systems.
(c) Requirements.--
(1) In general.--Recipients of grants, contracts,
and cooperative agreements under this section shall
comply with information and application requirements
determined appropriate by the Secretary.
(2) Duration of award.--With respect to a grant,
contract, or cooperative agreement awarded under this
section, the period during which payments under such
award are made to the recipient may not exceed 5 years.
(3) Matching funds.--The Secretary may, for
projects carried out under subsection (a), require that
entities that apply for grants, contracts, or
cooperative agreements under this section provide non-
Federal matching funds, as determined appropriate by
the Secretary, to ensure the institutional commitment
of the entity to the projects funded under the grant,
contract, or cooperative agreement. Such non-Federal
matching funds may be provided directly or through
donations from public or private entities and may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services.
(4) Maintenance of effort.--With respect to
activities for which a grant, contract or cooperative
agreement is awarded under this section, the Secretary
may require that recipients for specific projects under
subsection (a) agree to maintain expenditures of non-
Federal amounts for such activities at a level that is
not less than the level of such expenditures maintained
by the entity for the fiscal year preceding the fiscal
year for which the entity receives such a grant,
contract, or cooperative agreement.
(d) Evaluation.--The Secretary shall evaluate each project
carried out under subsection (a)(1) and shall disseminate the
findings with respect to each such evaluation to appropriate
public and private entities.
(e) Information and Education.--
(1) In general.--The Secretary shall establish
information and education programs to disseminate and
apply the findings of the knowledge development and
application, training, and technical assistance
programs, and targeted capacity response programs,
under this section to the general public, to health
care professionals, and to interested groups. The
Secretary shall make every effort to provide linkages
between the findings of supported projects and State
agencies responsible for carrying out mental health
services.
(2) Rural and underserved areas.--In disseminating
information on evidence-based practices in the
provision of children's mental health services under
this subsection, the Secretary shall ensure that such
information is distributed to rural and medically
underserved areas.
(f ) Authorization of Appropriation.--
(1) In general.--There are authorized to be
appropriated to carry out this section, $300,000,000
for fiscal year 2001, and such sums as may be necessary
for each of the fiscal years 2002 and 2003.
(2) Data infrastructure.--If amounts are not
appropriated for a fiscal year to carry out section
1971 with respect to mental health, then the Secretary
shall make available, from the amounts appropriated for
such fiscal year under paragraph (1), an amount equal
to the sum of $6,000,000 and 10 percent of all amounts
appropriated for such fiscal year under such paragraph
in excess of $100,000,000, to carry out such section
1971.
SEC. 520B. [290BB-33] NATIONAL CENTERS OF EXCELLENCE FOR DEPRESSION.
(a) Depressive Disorder Defined.--In this section, the term
``depressive disorder'' means a mental or brain disorder
relating to depression, including major depression, bipolar
disorder, and related mood disorders.
(b) Grant Program.--
(1) In general.--The Secretary, acting through the
Administrator, shall award grants on a competitive
basis to eligible entities to establish national
centers of excellence for depression (referred to in
this section as ``Centers''), which shall engage in
activities related to the treatment of depressive
disorders.
(2) Allocation of awards.--If the funds authorized
under subsection (f) are appropriated in the amounts
provided for under such subsection, the Secretary shall
allocate such amounts so that--
(A) not later than 1 year after the date of
enactment of the ENHANCED Act of 2009, not more
than 20 Centers may be established; and
(B) not later than September 30, 2016, not
more than 30 Centers may be established.
(3) Grant period.--
(A) In general.--A grant awarded under this
section shall be for a period of 5 years.
(B) Renewal.--A grant awarded under
subparagraph (A) may be renewed, on a
competitive basis, for 1 additional 5-year
period, at the discretion of the Secretary. In
determining whether to renew a grant, the
Secretary shall consider the report cards
issued under subsection (e)(2).
(4) Use of funds.--Grant funds awarded under this
subsection shall be used for the establishment and
ongoing activities of the recipient of such funds.
(5) Eligible entities.--
(A) Requirements.--To be eligible to
receive a grant under this section, an entity
shall--
(i) be an institution of higher
education or a public or private
nonprofit research institution; and
(ii) submit an application to the
Secretary at such time and in such
manner as the Secretary may require, as
described in subparagraph (B).
(B) Application.--An application described
in subparagraph (A)(ii) shall include--
(i) evidence that such entity--
(I) provides, or is capable
of coordinating with other
entities to provide,
comprehensive health services
with a focus on mental health
services and subspecialty
expertise for depressive
disorders;
(II) collaborates with
other mental health providers,
as necessary, to address co-
occurring mental illnesses;
(III) is capable of
training health professionals
about mental health; and
(ii) such other information, as the
Secretary may require.
(C) Priorities.--In awarding grants under
this section, the Secretary shall give priority
to eligible entities that meet 1 or more of the
following criteria:
(i) Demonstrated capacity and
expertise to serve the targeted
population.
(ii) Existing infrastructure or
expertise to provide appropriate,
evidence-based and culturally and
linguistically competent services.
(iii) A location in a geographic
area with disproportionate numbers of
underserved and at-risk populations in
medically underserved areas and health
professional shortage areas.
(iv) Proposed innovative approaches
for outreach to initiate or expand
services.
(v) Use of the most up-to-date
science, practices, and interventions
available.
(vi) Demonstrated capacity to
establish cooperative and collaborative
agreements with community mental health
centers and other community entities to
provide mental health, social, and
human services to individuals with
depressive disorders.
(6) National coordinating center.--
(A) In general.--The Secretary, acting
through the Administrator, shall designate 1
recipient of a grant under this section to be
the coordinating center of excellence for
depression (referred to in this section as the
``coordinating center''). The Secretary shall
select such coordinating center on a
competitive basis, based upon the demonstrated
capacity of such center to perform the duties
described in subparagraph (C).
(B) Application.--A Center that has been
awarded a grant under paragraph (1) may apply
for designation as the coordinating center by
submitting an application to the Secretary at
such time, in such manner, and containing such
information as the Secretary may require.
(C) Duties.--The coordinating center
shall--
(i) develop, administer, and
coordinate the network of Centers under
this section;
(ii) oversee and coordinate the
national database described in
subsection (d);
(iii) lead a strategy to
disseminate the findings and activities
of the Centers through such database;
and
(iv) serve as a liaison with the
Administration, the National Registry
of Evidence-based Programs and
Practices of the Administration, and
any Federal interagency or interagency
forum on mental health.
(7) Matching funds.--The Secretary may not award a
grant or contract under this section to an entity
unless the entity agrees that it will make available
(directly or through contributions from other public or
private entities) non-Federal contributions toward the
activities to be carried out under the grant or
contract in an amount equal to $1 for each $5 of
Federal funds provided under the grant or contract.
Such non-Federal matching funds may be provided
directly or through donations from public or private
entities and may be in cash or in-kind, fairly
evaluated, including plant, equipment, or services.
(c) Activities of the Centers.--Each Center shall carry out
the following activities:
(1) General activities.--Each Center shall--
(A) integrate basic, clinical, or health
services interdisciplinary research and
practice in the development, implementation,
and dissemination of evidence-based
interventions;
(B) involve a broad cross-section of
stakeholders, such as researchers, clinicians,
consumers, families of consumers, and voluntary
health organizations, to develop a research
agenda and disseminate findings, and to provide
support in the implementation of evidence-based
practices;
(C) provide training and technical
assistance to mental health professionals, and
engage in and disseminate translational
research with a focus on meeting the needs of
individuals with depressive disorders; and
(D) educate policy makers, employers,
community leaders, and the public about
depressive disorders to reduce stigma and raise
awareness of treatments.
(2) Improved treatment standards, clinical
guidelines, diagnostic protocols, and care coordination
practice.--Each Center shall collaborate with other
Centers in the network to--
(A) develop and implement treatment
standards, clinical guidelines, and protocols
that emphasize primary prevention, early
intervention, treatment for, and recovery from,
depressive disorders;
(B) foster communication with other
providers attending to co-occurring physical
health conditions such as cardiovascular,
diabetes, cancer, and substance abuse
disorders;
(C) leverage available community resources,
develop and implement improved self-management
programs, and, when appropriate, involve family
and other providers of social support in the
development and implementation of care plans;
and
(D) use electronic health records and
telehealth technology to better coordinate and
manage, and improve access to, care, as
determined by the coordinating center.
(3) Translational research through collaboration of
centers and community-based organizations.--Each Center
shall--
(A) demonstrate effective use of a public-
private partnership to foster collaborations
among members of the network and community-
based organizations such as community mental
health centers and other social and human
services providers;
(B) expand interdisciplinary,
translational, and patient-oriented research
and treatment; and
(C) coordinate with accredited academic
programs to provide ongoing opportunities for
the professional and continuing education of
mental health providers.
(d) National Database.--
(1) In general.--The coordinating center shall
establish and maintain a national, publicly available
database to improve prevention programs, evidence-based
interventions, and disease management programs for
depressive disorders, using data collected from the
Centers, as described in paragraph (2).
(2) Data collection.--Each Center shall submit data
gathered at such center, as appropriate, to the
coordinating center regarding--
(A) the prevalence and incidence of
depressive disorders;
(B) the health and social outcomes of
individuals with depressive disorders;
(C) the effectiveness of interventions
designed, tested, and evaluated;
(D) other information, as the Secretary may
require.
(3) Submission of data to the administrator.--The
coordinating center shall submit to the Administrator
the data and financial information gathered under
paragraph (2).
(4) Publication using data from the database.--A
Center, or an individual affiliated with a Center, may
publish findings using the data described in paragraph
(2) only if such center submits such data to the
coordinating center, as required under such paragraph.
(e) Establishment of Standards; Report Cards and
Recommendations; Third Party Review.--
(1) Establishment of standards.--The Secretary,
acting through the Administrator, shall establish
performance standards for--
(A) each Center; and
(B) the network of Centers as a whole.
(2) Report cards.--The Secretary, acting through
the Administrator, shall--
(A) for each Center, not later than 3 years
after the date on which such center of
excellence is established and annually
thereafter, issue a report card to the
coordinating center to rate the performance of
such Center; and
(B) not later than 3 years after the date
on which the first grant is awarded under
subsection (b)(1) and annually thereafter,
issue a report card to Congress to rate the
performance of the network of centers of
excellence as a whole.
(3) Recommendations.--Based upon the report cards
described in paragraph (2), the Secretary shall, not
later than September 30, 2015--
(A) make recommendations to the Centers
regarding improvements such centers shall make;
and
(B) make recommendations to Congress for
expanding the Centers to serve individuals with
other types of mental disorders.
(4) Third party review.--Not later than 3 years
after the date on which the first grant is awarded
under subsection (b)(1) and annually thereafter, the
Secretary shall arrange for an independent third party
to conduct an evaluation of the network of Centers to
ensure that such centers are meeting the goals of this
section.
(f) Authorization of Appropriations.--
(1) In general.--To carry out this section, there
are authorized to be appropriated--
(A) $100,000,000 for each of the fiscal
years 2011 through 2015; and
(B) $150,000,000 for each of the fiscal
years 2016 through 2020.
(2) Allocation of funds authorized.--Of the amount
appropriated under paragraph (1) for a fiscal year, the
Secretary shall determine the allocation of each Center
receiving a grant under this section, but in no case
may the allocation be more than $5,000,000, except that
the Secretary may allocate not more than $10,000,000 to
the coordinating center.
SEC. 520C. [290BB-34] YOUTH INTERAGENCY RESEARCH, TRAINING, AND
TECHNICAL ASSISTANCE CENTERS.
(a) Program Authorized.--The Secretary, acting through the
Administrator of the Substance Abuse and Mental Health Services
Administration, and in consultation with the Administrator of
the Office of Juvenile Justice and Delinquency Prevention, the
Director of the Bureau of Justice Assistance and the Director
of the National Institutes of Health--
(1) shall award grants or contracts to public or
nonprofit private entities to establish not more than
four research, training, and technical assistance
centers to carry out the activities described in
subsection (c); and
(2) shall award a competitive grant to 1 additional
research, training, and technical assistance center to
carry out the activities described in subsection (d).
(b) Application.--A public or private nonprofit entity
desiring a grant or contract under subsection (a) shall prepare
and submit an application to the Secretary at such time, in
such manner, and containing such information as the Secretary
may require.
(c) Authorized Activities.--A center established under a
grant or contract under subsection (a)(1) shall--
(1) provide training with respect to state-of-the-
art mental health and justice-related services and
successful mental health and substance abuse-justice
collaborations that focus on children and adolescents,
to public policymakers, law enforcement administrators,
public defenders, police, probation officers, judges,
parole officials, jail administrators and mental health
and substance abuse providers and administrators;
(2) engage in research and evaluations concerning
State and local justice and mental health systems,
including system redesign initiatives, and disseminate
information concerning the results of such evaluations;
(3) provide direct technical assistance, including
assistance provided through toll-free telephone
numbers, concerning issues such as how to accommodate
individuals who are being processed through the courts
under the Americans with Disabilities Act of 1990 (42
U.S.C. 12101 et seq.), what types of mental health or
substance abuse service approaches are effective within
the judicial system, and how community-based mental
health or substance abuse services can be more
effective, including relevant regional, ethnic, and
gender-related considerations; and
(4) provide information, training, and technical
assistance to State and local governmental officials to
enhance the capacity of such officials to provide
appropriate services relating to mental health or
substance abuse.
(d) Additional Center.--The additional research, training,
and technical assistance center established under subsection
(a)(2) shall provide appropriate information, training, and
technical assistance to States, political subdivisions of a
State, Federally recognized Indian tribes, tribal
organizations, institutions of higher education, public
organizations, or private nonprofit organizations for--
(1) the development or continuation of statewide or
tribal youth suicide early intervention and prevention
strategies;
(2) ensuring the surveillance of youth suicide
early intervention and prevention strategies;
(3) studying the costs and effectiveness of
statewide youth suicide early intervention and
prevention strategies in order to provide information
concerning relevant issues of importance to State,
tribal, and national policymakers;
(4) further identifying and understanding causes
and associated risk factors for youth suicide;
(5) analyzing the efficacy of new and existing
youth suicide early intervention techniques and
technology;
(6) ensuring the surveillance of suicidal behaviors
and nonfatal suicidal attempts;
(7) studying the effectiveness of State-sponsored
statewide and tribal youth suicide early intervention
and prevention strategies on the overall wellness and
health promotion strategies related to suicide
attempts;
(8) promoting the sharing of data regarding youth
suicide with Federal agencies involved with youth
suicide early intervention and prevention, and State-
sponsored statewide or tribal youth suicide early
intervention and prevention strategies for the purpose
of identifying previously unknown mental health causes
and associated risk factors for suicide in youth;
(9) evaluating and disseminating outcomes and best
practices of mental and behavioral health services at
institutions of higher education; and
(10) other activities determined appropriate by the
Secretary.
(e) Authorization of Appropriations.--
(1) For the purpose of awarding grants or contracts
under subsection (a)(1), there is authorized to be
appropriated $4,000,000 for fiscal year 2001, and such
sums as may be necessary for fiscal years 2002 and
2003.
(2) For the purpose of awarding a grant under
subsection (a)(2), there are authorized to be
appropriated $3,000,000 for fiscal year 2005,
$4,000,000 for fiscal year 2006, and $5,000,000 for
fiscal year 2007.
SEC. 520D. [290BB-35] SERVICES FOR YOUTH OFFENDERS.
(a) In General.--The Secretary, acting through the Director
of the Center for Mental Health Services, and in consultation
with the Director of the Center for Substance Abuse Treatment,
the Administrator of the Office of Juvenile Justice and
Delinquency Prevention, and the Director of the Special
Education Programs, shall award grants on a competitive basis
to State or local juvenile justice agencies to enable such
agencies to provide aftercare services for youth offenders who
have been discharged from facilities in the juvenile or
criminal justice system and have serious emotional disturbances
or are at risk of developing such disturbances.
(b) Use of Funds.--A State or local juvenile justice agency
receiving a grant under subsection (a) shall use the amounts
provided under the grant--
(1) to develop a plan describing the manner in
which the agency will provide services for each youth
offender who has a serious emotional disturbance and
has been detained or incarcerated in facilities within
the juvenile or criminal justice system;
(2) to provide a network of core or aftercare
services or access to such services for each youth
offender, including diagnostic and evaluation services,
substance abuse treatment services, outpatient mental
health care services, medication management services,
intensive home-based therapy, intensive day treatment
services, respite care, and therapeutic foster care;
(3) to establish a program that coordinates with
other State and local agencies providing recreational,
social, educational, vocational, or operational
services for youth, to enable the agency receiving a
grant under this section to provide community-based
system of care services for each youth offender that
addresses the special needs of the youth and helps the
youth access all of the aforementioned services; and
(4) using not more than 20 percent of funds
received, to provide planning and transition services
as described in paragraph (3) for youth offenders while
such youth are incarcerated or detained.
(c) Application.--A State or local juvenile justice agency
that desires a grant under subsection (a) shall submit an
application to the Secretary at such time, in such manner, and
accompanied by such information as the Secretary may reasonably
require.
(d) Report.--Not later than 3 years after the date of the
enactment of this section and annually thereafter, the
Secretary shall prepare and submit, to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Commerce of the House of Representatives, a report that
describes the services provided pursuant to this section.
(e) Definitions.--In this section:
(1) Serious emotional disturbance.--The term
``serious emotional disturbance'' with respect to a
youth offender means an offender who currently, or at
any time within the 1-year period ending on the day on
which services are sought under this section, has a
diagnosable mental, behavioral, or emotional disorder
that functionally impairs the offender's life by
substantially limiting the offender's role in family,
school, or community activities, and interfering with
the offender's ability to achieve or maintain one or
more developmentally-appropriate social, behavior,
cognitive, communicative, or adaptive skills.
(2) Community-based system of care.--The term
``community-based system of care'' means the provision
of services for the youth offender by various State or
local agencies that in an interagency fashion or
operating as a network addresses the recreational,
social, educational, vocational, mental health,
substance abuse, and operational needs of the youth
offender.
(3) Youth offender.--The term ``youth offender''
means an individual who is 21 years of age or younger
who has been discharged from a State or local juvenile
or criminal justice system, except that if the
individual is between the ages of 18 and 21 years, such
individual has had contact with the State or local
juvenile or criminal justice system prior to attaining
18 years of age and is under the jurisdiction of such a
system at the time services are sought.
(f ) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $40,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 and 2003.
SEC. 520E. [290BB-36] YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION
STRATEGIES.
(a) In General.--The Secretary, acting through the
Administrator of the Substance Abuse and Mental Health Services
Administration, shall award grants or cooperative agreements to
eligible entities to--
(1) develop and implement State-sponsored statewide
or tribal youth suicide early intervention and
prevention strategies in schools, educational
institutions, juvenile justice systems, substance abuse
programs, mental health programs, foster care systems,
and other child and youth support organizations;
(2) support public organizations and private
nonprofit organizations actively involved in State-
sponsored statewide or tribal youth suicide early
intervention and prevention strategies and in the
development and continuation of State-sponsored
statewide youth suicide early intervention and
prevention strategies;
(3) provide grants to institutions of higher
education to coordinate the implementation of State-
sponsored statewide or tribal youth suicide early
intervention and prevention strategies;
(4) collect and analyze data on State-sponsored
statewide or tribal youth suicide early intervention
and prevention services that can be used to monitor the
effectiveness of such services and for research,
technical assistance, and policy development; and
(5) assist eligible entities, through State-
sponsored statewide or tribal youth suicide early
intervention and prevention strategies, in achieving
targets for youth suicide reductions under title V of
the Social Security Act.
(b) Eligible Entity.--
(1) Definition.--In this section, the term
``eligible entity'' means--
(A) a State;
(B) a public organization or private
nonprofit organization designated by a State to
develop or direct the State-sponsored statewide
youth suicide early intervention and prevention
strategy; or
(C) a Federally recognized Indian tribe or
tribal organization (as defined in the Indian
Self-Determination and Education Assistance
Act) or an urban Indian organization (as
defined in the Indian Health Care Improvement
Act) that is actively involved in the
development and continuation of a tribal youth
suicide early intervention and prevention
strategy.
(2) Limitation.--In carrying out this section, the
Secretary shall ensure that each State is awarded only
1 grant or cooperative agreement under this section.
For purposes of the preceding sentence, a State shall
be considered to have been awarded a grant or
cooperative agreement if the eligible entity involved
is the State or an entity designated by the State under
paragraph (1)(B). Nothing in this paragraph shall be
construed to apply to entities described in paragraph
(1)(C).
(c) Preference.--In providing assistance under a grant or
cooperative agreement under this section, an eligible entity
shall give preference to public organizations, private
nonprofit organizations, political subdivisions, institutions
of higher education, and tribal organizations actively involved
with the State-sponsored statewide or tribal youth suicide
early intervention and prevention strategy that--
(1) provide early intervention and assessment
services, including screening programs, to youth who
are at risk for mental or emotional disorders that may
lead to a suicide attempt, and that are integrated with
school systems, educational institutions, juvenile
justice systems, substance abuse programs, mental
health programs, foster care systems, and other child
and youth support organizations;
(2) demonstrate collaboration among early
intervention and prevention services or certify that
entities will engage in future collaboration;
(3) employ or include in their applications a
commitment to evaluate youth suicide early intervention
and prevention practices and strategies adapted to the
local community;
(4) provide timely referrals for appropriate
community-based mental health care and treatment of
youth who are at risk for suicide in child-serving
settings and agencies;
(5) provide immediate support and information
resources to families of youth who are at risk for
suicide;
(6) offer access to services and care to youth with
diverse linguistic and cultural backgrounds;
(7) offer appropriate postsuicide intervention
services, care, and information to families, friends,
schools, educational institutions, juvenile justice
systems, substance abuse programs, mental health
programs, foster care systems, and other child and
youth support organizations of youth who recently
completed suicide;
(8) offer continuous and up-to-date information and
awareness campaigns that target parents, family
members, child care professionals, community care
providers, and the general public and highlight the
risk factors associated with youth suicide and the
life-saving help and care available from early
intervention and prevention services;
(9) ensure that information and awareness campaigns
on youth suicide risk factors, and early intervention
and prevention services, use effective communication
mechanisms that are targeted to and reach youth,
families, schools, educational institutions, and youth
organizations;
(10) provide a timely response system to ensure
that child-serving professionals and providers are
properly trained in youth suicide early intervention
and prevention strategies and that child-serving
professionals and providers involved in early
intervention and prevention services are properly
trained in effectively identifying youth who are at
risk for suicide;
(11) provide continuous training activities for
child care professionals and community care providers
on the latest youth suicide early intervention and
prevention services practices and strategies;
(12) conduct annual self-evaluations of outcomes
and activities, including consulting with interested
families and advocacy organizations;
(13) provide services in areas or regions with
rates of youth suicide that exceed the national average
as determined by the Centers for Disease Control and
Prevention; and
(14) obtain informed written consent from a parent
or legal guardian of an at-risk child before involving
the child in a youth suicide early intervention and
prevention program.
(d) Requirement for Direct Services.--Not less than 85
percent of grant funds received under this section shall be
used to provide direct services, of which not less than 5
percent shall be used for activities authorized under
subsection (a)(3).
(e) Coordination and Collaboration.--
(1) In general.--In carrying out this section, the
Secretary shall collaborate with relevant Federal
agencies and suicide working groups responsible for
early intervention and prevention services relating to
youth suicide.
(2) Consultation.--In carrying out this section,
the Secretary shall consult with--
(A) State and local agencies, including
agencies responsible for early intervention and
prevention services under title XIX of the
Social Security Act, the State Children's
Health Insurance Program under title XXI of the
Social Security Act, and programs funded by
grants under title V of the Social Security
Act;
(B) local and national organizations that
serve youth at risk for suicide and their
families;
(C) relevant national medical and other
health and education specialty organizations;
(D) youth who are at risk for suicide, who
have survived suicide attempts, or who are
currently receiving care from early
intervention services;
(E) families and friends of youth who are
at risk for suicide, who have survived suicide
attempts, who are currently receiving care from
early intervention and prevention services, or
who have completed suicide;
(F) qualified professionals who possess the
specialized knowledge, skills, experience, and
relevant attributes needed to serve youth at
risk for suicide and their families; and
(G) third-party payers, managed care
organizations, and related commercial
industries.
(3) Policy development.--In carrying out this
section, the Secretary shall--
(A) coordinate and collaborate on policy
development at the Federal level with the
relevant Department of Health and Human
Services agencies and suicide working groups;
and
(B) consult on policy development at the
Federal level with the private sector,
including consumer, medical, suicide prevention
advocacy groups, and other health and education
professional-based organizations, with respect
to State-sponsored statewide or tribal youth
suicide early intervention and prevention
strategies.
(f) Rule of Construction; Religious and Moral
Accommodation.--Nothing in this section shall be construed to
require suicide assessment, early intervention, or treatment
services for youth whose parents or legal guardians object
based on the parents' or legal guardians' religious beliefs or
moral objections.
(g) Evaluations and Report.--
(1) Evaluations by eligible entities.--Not later
than 18 months after receiving a grant or cooperative
agreement under this section, an eligible entity shall
submit to the Secretary the results of an evaluation to
be conducted by the entity concerning the effectiveness
of the activities carried out under the grant or
agreement.
(2) Report.--Not later than 2 years after the date
of enactment of this section, the Secretary shall
submit to the appropriate committees of Congress a
report concerning the results of--
(A) the evaluations conducted under
paragraph (1); and
(B) an evaluation conducted by the
Secretary to analyze the effectiveness and
efficacy of the activities conducted with
grants, collaborations, and consultations under
this section.
(h) Rule of Construction; Student Medication.--Nothing in
this section or section 520E-1 shall be construed to allow
school personnel to require that a student obtain any
medication as a condition of attending school or receiving
services.
(i) Prohibition.--Funds appropriated to carry out this
section, section 520C, section 520E-1, or section 520E-2 shall
not be used to pay for or refer for abortion.
(j) Parental consent.--States and entities receiving
funding under this section and section 520E-1 shall obtain
prior written, informed consent from the child's parent or
legal guardian for assessment services, school-sponsored
programs, and treatment involving medication related to youth
suicide conducted in elementary and secondary schools. The
requirement of the preceding sentence does not apply in the
following cases:
(1) In an emergency, where it is necessary to
protect the immediate health and safety of the student
or other students.
(2) Other instances, as defined by the State, where
parental consent cannot reasonably be obtained.
(k) Relation to Education Provisions.--Nothing in this
section or section 520E-1 shall be construed to supersede
section 444 of the General Education Provisions Act, including
the requirement of prior parental consent for the disclosure of
any education records. Nothing in this section or section 520E-
1 shall be construed to modify or affect parental notification
requirements for programs authorized under the Elementary and
Secondary Education Act of 1965 (as amended by the No Child
Left Behind Act of 2001; Public Law 107-110).
(l) Definitions.--In this section:
(1) Early intervention.--The term ``early
intervention'' means a strategy or approach that is
intended to prevent an outcome or to alter the course
of an existing condition.
(2) Educational institution; institution of higher
education; school.--The term--
(A) ``educational institution'' means a
school or institution of higher education;
(B) ``institution of higher education'' has
the meaning given such term in section 101 of
the Higher Education Act of 1965; and
(C) ``school'' means an elementary or
secondary school (as such terms are defined in
section 9101 of the Elementary and Secondary
Education Act of 1965).
(3) Prevention.--The term ``prevention'' means a
strategy or approach that reduces the likelihood or
risk of onset, or delays the onset, of adverse health
problems that have been known to lead to suicide.
(4) Youth.--The term ``youth'' means individuals
who are between 10 and 24 years of age.
(m) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out
this section, there are authorized to be appropriated
$7,000,000 for fiscal year 2005, $18,000,000 for fiscal
year 2006, and $30,000,000 for fiscal year 2007.
(2) Preference.--If less than $3,500,000 is
appropriated for any fiscal year to carry out this
section, in awarding grants and cooperative agreements
under this section during the fiscal year, the
Secretary shall give preference to States that have
rates of suicide that significantly exceed the national
average as determined by the Centers for Disease
Control and Prevention.
SEC. 520E-1. [290BB-36A] SUICIDE PREVENTION FOR CHILDREN AND
ADOLESCENTS \1\.
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\1\ The probable intent of the Congress is that the heading be
``SUICIDE PREVENTION FOR YOUTH''. See the amendment described in
section 3(b)(1)(A) of Public Law 108-355 (118 Stat. 1407). The
amendment cannot be executed because the matter in the heading to be
struck does not appear, as the amendatory instruction used the wrong
font. The amendment referred to ``CHILDREN AND ADOLESCENTS'' rather
than ``CHILDREN AND ADOLESCENTS''. (The amendment is directed to
section ``520E''. Section 520E-1 above formerly was section 520E, and
was redesignated by section 3(b)(2) of such Public Law.)
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(a) In General.--The Secretary shall award grants or
cooperative agreements to public organizations, private
nonprofit organizations, political subdivisions, consortia of
political subdivisions, consortia of States, or Federally
recognized Indian tribes or tribal organizations to design
early intervention and prevention strategies that will
complement the State-sponsored statewide or tribal youth
suicide early intervention and prevention strategies developed
pursuant to section 520E.
(b) Collaboration.--In carrying out subsection (a), the
Secretary shall ensure that activities under this section are
coordinated with the relevant Department of Health and Human
Services agencies and suicide working groups.
(c) Requirements.--A public organization, private nonprofit
organization, political subdivision, consortium of political
subdivisions, consortium of States, or federally recognized
Indian tribe or tribal organization desiring a grant, contract,
or cooperative agreement under this section shall demonstrate
that the suicide prevention program such entity proposes will--
(1)(A) comply with the State-sponsored statewide
early intervention and prevention strategy as developed
under section 520E; and
(B) in the case of a consortium of States, receive
the support of all States involved;
(2) provide for the timely assessment, treatment,
or referral for mental health or substance abuse
services of youth at risk for suicide;
(3) be based on suicide prevention practices and
strategies that are adapted to the local community;
(4) integrate its suicide prevention program into
the existing health care system in the community
including general, mental, and behavioral health
services, and substance abuse services;
(5) be integrated into other systems in the
community that address the needs of youth including the
school systems, educational institutions, juvenile
justice system, substance abuse programs, mental health
programs, foster care systems, and community child and
youth support organizations;
(6) use primary prevention methods to educate and
raise awareness in the local community by disseminating
evidence-based information about suicide prevention;
(7) include suicide prevention, mental health, and
related information and services for the families and
friends of those who completed suicide, as needed;
(8) offer access to services and care to youth with
diverse linguistic and cultural backgrounds;
(9) conduct annual self-evaluations of outcomes and
activities, including consulting with interested
families and advocacy organizations; \1\
---------------------------------------------------------------------------
\1\ So in law. Probably should include ``and'' after the semicolon
at the end of paragraph (9). See section 3(b)(1)(D)(ix) of Public Law
108-355 (118 Stat. 1408).
---------------------------------------------------------------------------
(10) ensure that staff used in the program are
trained in suicide prevention and that professionals
involved in the system of care have received training
in identifying persons at risk of suicide.
(d) Use of Funds.--Amounts provided under a grant or
cooperative agreement under this section shall be used to
supplement, and not supplant, Federal and non-Federal funds
available for carrying out the activities described in this
section. Applicants shall provide financial information to
demonstrate compliance with this section.
(e) Condition.--An applicant for a grant or cooperative
agreement under subsection (a) shall demonstrate to the
Secretary that the application complies with the State-
sponsored statewide early intervention and prevention strategy
as developed under section 520E and the applicant has the
support of the local community and relevant public health
officials.
(f ) Special Populations.--In awarding grants and
cooperative agreements under subsection (a), the Secretary
shall ensure that such awards are made in a manner that will
focus on the needs of communities or groups that experience
high or rapidly rising rates of suicide.
(g) Application.--A public organization, private nonprofit
organization, political subdivision, consortium of political
subdivisions, consortium of States, or Federally recognized
Indian tribe or tribal organization receiving a grant or
cooperative agreement under subsection (a) shall prepare and
submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
reasonably require. Such application shall include a plan for
the rigorous evaluation of activities funded under the grant or
cooperative agreement, including a process and outcome
evaluation.
(h) Distribution of Awards.--In awarding grants and
cooperative agreements under subsection (a), the Secretary
shall ensure that such awards are distributed among the
geographical regions of the United States and between urban and
rural settings.
(i) Evaluation.--A public organization, private nonprofit
organization, political subdivision, consortium of political
subdivisions, consortium of States, or Federally recognized
Indian tribe or tribal organization receiving a grant or
cooperative agreement under subsection (a) shall prepare and
submit to the Secretary at the end of the program period, an
evaluation of all activities funded under this section.
( j) Dissemination and Education.--The Secretary shall
ensure that findings derived from activities carried out under
this section are disseminated to State, county and local
governmental agencies and public and private nonprofit
organizations active in promoting suicide prevention and family
support activities.
(k) Duration of Projects.--With respect to a grant,
contract, or cooperative agreement \1\ awarded under this
section, the period during which payments under such award may
be made to the recipient may not exceed 3 years.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``grant or cooperative
agreement''. See the amendments made by section 3(b) of Public Law 108-
355 (118 Stat. 1407).
---------------------------------------------------------------------------
(l) Study.--Within 1 year after the date of the enactment
of this section, the Secretary shall, directly or by grant or
contract, initiate a study to assemble and analyze data to
identify--
(1) unique profiles of children under 13 who
attempt or complete suicide;
(2) unique profiles of youths between ages 13 and
24 who attempt or complete suicide; and
(3) a profile of services available to these groups
and the use of these services by children and youths
from paragraphs (1) and (2).
(m) Definitions.--In this section, the terms ``early
intervention'', ``educational institution'', ``institution of
higher education'', ``prevention'', ``school'', and ``youth''
have the meanings given to those terms in section 520E.
(n) Authorization of Appropriation.--For purposes of
carrying out this section, there is authorized to be
appropriated $75,000,000 for fiscal year 2001 and such sums as
may be necessary for each of the fiscal years 2002 through
2003.
SEC. 520E-2. [290BB-36B] MENTAL AND BEHAVIORAL HEALTH SERVICES ON
CAMPUS.
(a) In General.--The Secretary, acting through the Director
of the Center for Mental Health Services, in consultation with
the Secretary of Education, may award grants on a competitive
basis to institutions of higher education to enhance services
for students with mental and behavioral health problems that
can lead to school failure, such as depression, substance
abuse, and suicide attempts, so that students will successfully
complete their studies.
(b) Use of Funds.--The Secretary may not make a grant to an
institution of higher education under this section unless the
institution agrees to use the grant only for--
(1) educational seminars;
(2) the operation of hot lines;
(3) preparation of informational material;
(4) preparation of educational materials for
families of students to increase awareness of potential
mental and behavioral health issues of students
enrolled at the institution of higher education;
(5) training programs for students and campus
personnel to respond effectively to students with
mental and behavioral health problems that can lead to
school failure, such as depression, substance abuse,
and suicide attempts; or
(6) the creation of a networking infrastructure to
link colleges and universities that do not have mental
health services with health care providers who can
treat mental and behavioral health problems.
(c) Eligible grant recipients.--Any institution of higher
education receiving a grant under this section may carry out
activities under the grant through--
(1) college counseling centers;
(2) college and university psychological service
centers;
(3) mental health centers;
(4) psychology training clinics; or
(5) institution of higher education supported,
evidence-based, mental health and substance abuse
programs.
(d) Application.--An institution of higher education
desiring a grant under this section shall prepare and submit an
application to the Secretary at such time and in such manner as
the Secretary may require. At a minimum, the application shall
include the following:
(1) A description of identified mental and
behavioral health needs of students at the institution
of higher education.
(2) A description of Federal, State, local,
private, and institutional resources currently
available to address the needs described in paragraph
(1) at the institution of higher education.
(3) A description of the outreach strategies of the
institution of higher education for promoting access to
services, including a proposed plan for reaching those
students most in need of mental health services.
(4) A plan to evaluate program outcomes, including
a description of the proposed use of funds, the program
objectives, and how the objectives will be met.
(5) An assurance that the institution will submit a
report to the Secretary each fiscal year on the
activities carried out with the grant and the results
achieved through those activities.
(e) Requirement of Matching Funds.--
(1) In general.--The Secretary may make a grant
under this section to an institution of higher
education only if the institution agrees to make
available (directly or through donations from public or
private entities) non-Federal contributions in an
amount that is not less than $1 for each $1 of Federal
funds provided in the grant, toward the costs of
activities carried out with the grant (as described in
subsection (b)) and other activities by the institution
to reduce student mental and behavioral health
problems.
(2) Determination of amount contributed.--Non-
Federal contributions required under paragraph (1) may
be in cash or in kind. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such non-
Federal contributions.
(3) Waiver.--The Secretary may waive the
requirement established in paragraph (1) with respect
to an institution of higher education if the Secretary
determines that extraordinary need at the institution
justifies the waiver.
(f) Reports.--For each fiscal year that grants are awarded
under this section, the Secretary shall conduct a study on the
results of the grants and submit to the Congress a report on
such results that includes the following:
(1) An evaluation of the grant program outcomes,
including a summary of activities carried out with the
grant and the results achieved through those
activities.
(2) Recommendations on how to improve access to
mental and behavioral health services at institutions
of higher education, including efforts to reduce the
incidence of suicide and substance abuse.
(g) Definition.--In this section, the term ``institution of
higher education'' has the meaning given such term in section
101 of the Higher Education Act of 1965.
(h) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2005, $5,000,000 for
fiscal year 2006, and $5,000,000 for fiscal year 2007.
SEC. 520F. [290BB-37] GRANTS FOR EMERGENCY MENTAL HEALTH CENTERS.
(a) Program Authorized.--The Secretary shall award grants
to States, political subdivisions of States, Indian tribes, and
tribal organizations to support the designation of hospitals
and health centers as Emergency Mental Health Centers.
(b) Health Center.--In this section, the term ``health
center'' has the meaning given such term in section 330, and
includes community health centers and community mental health
centers.
(c) Distribution of Awards.--The Secretary shall ensure
that such grants awarded under subsection (a) are equitably
distributed among the geographical regions of the United
States, between urban and rural populations, and between
different settings of care including health centers, mental
health centers, hospitals, and other psychiatric units or
facilities.
(d) Application.--A State, political subdivision of a
State, Indian tribe, or tribal organization that desires a
grant under subsection (a) shall submit an application to the
Secretary at such time, in such manner, and containing such
information as the Secretary may require, including a plan for
the rigorous evaluation of activities carried out with funds
received under this section.
(e) Use of Funds.--
(1) In general.--A State, political subdivision of
a State, Indian tribe, or tribal organization receiving
a grant under subsection (a) shall use funds from such
grant to establish or designate hospitals and health
centers as Emergency Mental Health Centers.
(2) Emergency mental health centers.--Such
Emergency Mental Health Centers described in paragraph
(1)--
(A) shall--
(i) serve as a central receiving
point in the community for individuals
who may be in need of emergency mental
health services;
(ii) purchase, if needed, any
equipment necessary to evaluate,
diagnose and stabilize an individual
with a mental illness;
(iii) provide training, if needed,
to the medical personnel staffing the
Emergency Mental Health Center to
evaluate, diagnose, stabilize, and
treat an individual with a mental
illness; and
(iv) provide any treatment that is
necessary for an individual with a
mental illness or a referral for such
individual to another facility where
such treatment may be received; and
(B) may establish and train a mobile crisis
intervention team to respond to mental health
emergencies within the community.
(f ) Evaluation.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under subsection (a) shall prepare and submit an
evaluation to the Secretary at such time, in such manner, and
containing such information as the Secretary may reasonably
require, including an evaluation of activities carried out with
funds received under this section and a process and outcomes
evaluation.
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $25,000,000 for
fiscal year 2001 and such sums as may be necessary for each of
the fiscal years 2002 through 2003.
SEC. 520G. [290BB-38] GRANTS FOR JAIL DIVERSION PROGRAMS.
(a) Program Authorized.--The Secretary shall make up to 125
grants to States, political subdivisions of States, Indian
tribes, and tribal organizations, acting directly or through
agreements with other public or nonprofit entities, to develop
and implement programs to divert individuals with a mental
illness from the criminal justice system to community-based
services.
(b) Administration.--
(1) Consultation.--The Secretary shall consult with
the Attorney General and any other appropriate
officials in carrying out this section.
(2) Regulatory authority.--The Secretary shall
issue regulations and guidelines necessary to carry out
this section, including methodologies and outcome
measures for evaluating programs carried out by States,
political subdivisions of States, Indian tribes, and
tribal organizations receiving grants under subsection
(a).
(c) Applications.--
(1) In general.--To receive a grant under
subsection (a), the chief executive of a State, chief
executive of a subdivision of a State, Indian tribe or
tribal organization shall prepare and submit an
application to the Secretary at such time, in such
manner, and containing such information as the
Secretary shall reasonably require.
(2) Content.--Such application shall--
(A) contain an assurance that--
(i) community-based mental health
services will be available for the
individuals who are diverted from the
criminal justice system, and that such
services are based on the best known
practices, reflect current research
findings, include case management,
assertive community treatment,
medication management and access,
integrated mental health and co-
occurring substance abuse treatment,
and psychiatric rehabilitation, and
will be coordinated with social
services, including life skills
training, housing placement, vocational
training, education job placement, and
health care;
(ii) there has been relevant
interagency collaboration between the
appropriate criminal justice, mental
health, and substance abuse systems;
and
(iii) the Federal support provided
will be used to supplement, and not
supplant, State, local, Indian tribe,
or tribal organization sources of
funding that would otherwise be
available;
(B) demonstrate that the diversion program
will be integrated with an existing system of
care for those with mental illness;
(C) explain the applicant's inability to
fund the program adequately without Federal
assistance;
(D) specify plans for obtaining necessary
support and continuing the proposed program
following the conclusion of Federal support;
and
(E) describe methodology and outcome
measures that will be used in evaluating the
program.
(d) Use of Funds.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under subsection (a) may use funds received under such
grant to--
(1) integrate the diversion program into the
existing system of care;
(2) create or expand community-based mental health
and co-occurring mental illness and substance abuse
services to accommodate the diversion program;
(3) train professionals involved in the system of
care, and law enforcement officers, attorneys, and
judges; and
(4) provide community outreach and crisis
intervention.
(e) Federal Share.--
(1) In general.--The Secretary shall pay to a
State, political subdivision of a State, Indian tribe,
or tribal organization receiving a grant under
subsection (a) the Federal share of the cost of
activities described in the application.
(2) Federal share.--The Federal share of a grant
made under this section shall not exceed 75 percent of
the total cost of the program carried out by the State,
political subdivision of a State, Indian tribe, or
tribal organization. Such share shall be used for new
expenses of the program carried out by such State,
political subdivision of a State, Indian tribe, or
tribal organization.
(3) Non-federal share.--The non-Federal share of
payments made under this section may be made in cash or
in kind fairly evaluated, including planned equipment
or services. The Secretary may waive the requirement of
matching contributions.
(f ) Geographic Distribution.--The Secretary shall ensure
that such grants awarded under subsection (a) are equitably
distributed among the geographical regions of the United States
and between urban and rural populations.
(g) Training and Technical Assistance.--Training and
technical assistance may be provided by the Secretary to assist
a State, political subdivision of a State, Indian tribe, or
tribal organization receiving a grant under subsection (a) in
establishing and operating a diversion program.
(h) Evaluations.--The programs described in subsection (a)
shall be evaluated not less than one time in every 12-month
period using the methodology and outcome measures identified in
the grant application.
(i) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $10,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 through 2003.
SEC. 520H. [290BB-39] IMPROVING OUTCOMES FOR CHILDREN AND ADOLESCENTS
THROUGH SERVICES INTEGRATION BETWEEN CHILD WELFARE
AND MENTAL HEALTH SERVICES.
(a) In General.--The Secretary shall award grants,
contracts or cooperative agreements to States, political
subdivisions of States, Indian tribes, and tribal organizations
to provide integrated child welfare and mental health services
for children and adolescents under 19 years of age in the child
welfare system or at risk for becoming part of the system, and
parents or caregivers with a mental illness or a mental illness
and a co-occurring substance abuse disorder.
(b) Duration.--With respect to a grant, contract or
cooperative agreement awarded under this section, the period
during which payments under such award are made to the
recipient may not exceed 5 years.
(c) Application.--
(1) In general.--To be eligible to receive an award
under subsection (a), a State, political subdivision of
a State, Indian tribe, or tribal organization shall
submit an application to the Secretary at such time, in
such manner, and accompanied by such information as the
Secretary may reasonably require.
(2) Content.--An application submitted under
paragraph (1) shall--
(A) describe the program to be funded under
the grant, contract or cooperative agreement;
(B) explain how such program reflects best
practices in the provision of child welfare and
mental health services; and
(C) provide assurances that--
(i) persons providing services
under the grant, contract or
cooperative agreement are adequately
trained to provide such services; and
(ii) the services will be provided
in accordance with subsection (d).
(d) Use of Funds.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant, contract, or cooperative agreement under subsection (a)
shall use amounts made available through such grant, contract
or cooperative agreement to--
(1) provide family-centered, comprehensive, and
coordinated child welfare and mental health services,
including prevention, early intervention and treatment
services for children and adolescents, and for their
parents or caregivers;
(2) ensure a single point of access for such
coordinated services;
(3) provide integrated mental health and substance
abuse treatment for children, adolescents, and parents
or caregivers with a mental illness and a co-occurring
substance abuse disorder;
(4) provide training for the child welfare, mental
health and substance abuse professionals who will
participate in the program carried out under this
section;
(5) provide technical assistance to child welfare
and mental health agencies;
(6) develop cooperative efforts with other service
entities in the community, including education, social
services, juvenile justice, and primary health care
agencies;
(7) coordinate services with services provided
under the Medicaid program and the State Children's
Health Insurance Program under titles XIX and XXI of
the Social Security Act;
(8) provide linguistically appropriate and
culturally competent services; and
(9) evaluate the effectiveness and cost-efficiency
of the integrated services that measure the level of
coordination, outcome measures for parents or
caregivers with a mental illness or a mental illness
and a co-occurring substance abuse disorder, and
outcome measures for children.
(e) Distribution of Awards.--The Secretary shall ensure
that grants, contracts, and cooperative agreements awarded
under subsection (a) are equitably distributed among the
geographical regions of the United States and between urban and
rural populations.
(f ) Evaluation.--The Secretary shall evaluate each program
carried out by a State, political subdivision of a State,
Indian tribe, or tribal organization under subsection (a) and
shall disseminate the findings with respect to each such
evaluation to appropriate public and private entities.
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $10,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 and 2003.
SEC. 520I. [290BB-40] GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS
MENTAL ILLNESS AND CO-OCCURRING SUBSTANCE ABUSE.
(a) In General.--The Secretary shall award grants,
contracts, or cooperative agreements to States, political
subdivisions of States, Indian tribes, tribal organizations,
and private nonprofit organizations for the development or
expansion of programs to provide integrated treatment services
for individuals with a serious mental illness and a co-
occurring substance abuse disorder.
(b) Priority.--In awarding grants, contracts, and
cooperative agreements under subsection (a), the Secretary
shall give priority to applicants that emphasize the provision
of services for individuals with a serious mental illness and a
co-occurring substance abuse disorder who--
(1) have a history of interactions with law
enforcement or the criminal justice system;
(2) have recently been released from incarceration;
(3) have a history of unsuccessful treatment in
either an inpatient or outpatient setting;
(4) have never followed through with outpatient
services despite repeated referrals; or
(5) are homeless.
(c) Use of Funds.--A State, political subdivision of a
State, Indian tribe, tribal organization, or private nonprofit
organization that receives a grant, contract, or cooperative
agreement under subsection (a) shall use funds received under
such grant--
(1) to provide fully integrated services rather
than serial or parallel services;
(2) to employ staff that are cross-trained in the
diagnosis and treatment of both serious mental illness
and substance abuse;
(3) to provide integrated mental health and
substance abuse services at the same location;
(4) to provide services that are linguistically
appropriate and culturally competent;
(5) to provide at least 10 programs for integrated
treatment of both mental illness and substance abuse at
sites that previously provided only mental health
services or only substance abuse services; and
(6) to provide services in coordination with other
existing public and private community programs.
(d) Condition.--The Secretary shall ensure that a State,
political subdivision of a State, Indian tribe, tribal
organization, or private nonprofit organization that receives a
grant, contract, or cooperative agreement under subsection (a)
maintains the level of effort necessary to sustain existing
mental health and substance abuse programs for other
populations served by mental health systems in the community.
(e) Distribution of Awards.--The Secretary shall ensure
that grants, contracts, or cooperative agreements awarded under
subsection (a) are equitably distributed among the geographical
regions of the United States and between urban and rural
populations.
(f ) Duration.--The Secretary shall award grants, contract,
or cooperative agreements under this subsection for a period of
not more than 5 years.
(g) Application.--A State, political subdivision of a
State, Indian tribe, tribal organization, or private nonprofit
organization that desires a grant, contract, or cooperative
agreement under this subsection shall prepare and submit an
application to the Secretary at such time, in such manner, and
containing such information as the Secretary may require. Such
application shall include a plan for the rigorous evaluation of
activities funded with an award under such subsection,
including a process and outcomes evaluation.
(h) Evaluation.--A State, political subdivision of a State,
Indian tribe, tribal organization, or private nonprofit
organization that receives a grant, contract, or cooperative
agreement under this subsection shall prepare and submit a plan
for the rigorous evaluation of the program funded under such
grant, contract, or agreement, including both process and
outcomes evaluation, and the submission of an evaluation at the
end of the project period.
(i) Authorization of Appropriation.--There is authorized to
be appropriated to carry out this subsection $40,000,000 for
fiscal year 2001, and such sums as may be necessary for fiscal
years 2002 through 2003.
SEC. 520J. [290BB-41] TRAINING GRANTS.
(a) In General.--The Secretary shall award grants in
accordance with the provisions of this section.
(b) Mental Illness Awareness Training Grants.--
(1) In general.--The Secretary shall award grants
to States, political subdivisions of States, Indian
tribes, tribal organizations, and nonprofit private
entities to train teachers and other relevant school
personnel to recognize symptoms of childhood and
adolescent mental disorders, to refer family members to
the appropriate mental health services if necessary, to
train emergency services personnel to identify and
appropriately respond to persons with a mental illness,
and to provide education to such teachers and personnel
regarding resources that are available in the community
for individuals with a mental illness.
(2) Emergency Services Personnel \1\.--In this
subsection, the term ``emergency services personnel''
includes paramedics, firefighters, and emergency
medical technicians.
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\1\So in law. Words in the heading (except the first) probably
should be all small caps. See section 3213 of Public Law 106-310 (114
Stat. 1206).
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(3) Distribution of Awards \1\.--The Secretary
shall ensure that such grants awarded under this
subsection are equitably distributed among the
geographical regions of the United States and between
urban and rural populations.
(4) Application.--A State, political subdivision of
a State, Indian tribe, tribal organization, or
nonprofit private entity that desires a grant under
this subsection shall submit an application to the
Secretary at such time, in such manner, and containing
such information as the Secretary may require,
including a plan for the rigorous evaluation of
activities that are carried out with funds received
under a grant under this subsection.
(5) Use of Funds.--A State, political subdivision
of a State, Indian tribe, tribal organization, or
nonprofit private entity receiving a grant under this
subsection shall use funds from such grant to--
(A) train teachers and other relevant
school personnel to recognize symptoms of
childhood and adolescent mental disorders and
appropriately respond;
(B) train emergency services personnel to
identify and appropriately respond to persons
with a mental illness; and
(C) provide education to such teachers and
personnel regarding resources that are
available in the community for individuals with
a mental illness.
(6) Evaluation.--A State, political subdivision of
a State, Indian tribe, tribal organization, or
nonprofit private entity that receives a grant under
this subsection shall prepare and submit an evaluation
to the Secretary at such time, in such manner, and
containing such information as the Secretary may
reasonably require, including an evaluation of
activities carried out with funds received under the
grant under this subsection and a process and outcome
evaluation.
(7) Authorization of Appropriations.--There is
authorized to be appropriated to carry out this
subsection, $25,000,000 for fiscal year 2001 and such
sums as may be necessary for each of fiscal years 2002
through 2003.
SEC. 520K. [290BB-42] AWARDS FOR CO-LOCATING PRIMARY AND SPECIALTY CARE
IN COMMUNITY-BASED MENTAL HEALTH SETTINGS.
(a) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity''
means a qualified community mental health program
defined under section 1913(b)(1).
(2) Special populations.--The term ``special
populations'' means adults with mental illnesses who
have co-occurring primary care conditions and chronic
diseases.
(b) Program Authorized.--The Secretary, acting through the
Administrator shall award grants and cooperative agreements to
eligible entities to establish demonstration projects for the
provision of coordinated and integrated services to special
populations through the co-location of primary and specialty
care services in community-based mental and behavioral health
settings.
(c) Application.--To be eligible to receive a grant or
cooperative agreement under this section, an eligible entity
shall submit an application to the Administrator at such time,
in such manner, and accompanied by such information as the
Administrator may require, including a description of
partnerships, or other arrangements with local primary care
providers, including community health centers, to provide
services to special populations.
(d) Use of Funds.--
(1) In general.--For the benefit of special
populations, an eligible entity shall use funds awarded
under this section for--
(A) the provision, by qualified primary
care professionals, of on site primary care
services;
(B) reasonable costs associated with
medically necessary referrals to qualified
specialty care professionals, other
coordinators of care or, if permitted by the
terms of the grant or cooperative agreement, by
qualified specialty care professionals on a
reasonable cost basis on site at the eligible
entity;
(C) information technology required to
accommodate the clinical needs of primary and
specialty care professionals; or
(D) facility modifications needed to bring
primary and specialty care professionals on
site at the eligible entity.
(2) Limitation.--Not to exceed 15 percent of grant
or cooperative agreement funds may be used for
activities described in subparagraphs (C) and (D) of
paragraph (1).
(e) Evaluation.--Not later than 90 days after a grant or
cooperative agreement awarded under this section expires, an
eligible entity shall submit to the Secretary the results of an
evaluation to be conducted by the entity concerning the
effectiveness of the activities carried out under the grant or
agreement.
(f) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $50,000,000 for
fiscal year 2010 and such sums as may be necessary for each of
fiscal years 2011 through 2014.
Part C--Projects for Assistance in Transition From Homelessness
SEC. 521. [290CC-21] FORMULA GRANTS TO STATES.
For the purpose of carrying out section 522, the Secretary,
acting through the Director of the Center for Mental Health
Services, shall for each of the fiscal years 1991 through 1994
\1\ make an allotment for each State in an amount determined in
accordance with section 524. The Secretary shall make payments,
as grants, each such fiscal year to each State from the
allotment for the State if the Secretary approves for the
fiscal year involved an application submitted by the State
pursuant to section 529.
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\1\ Probably should be ``2001 through 2003''. Section 3203(b) of
Public Law 106-310 (114 Stat. 1191) amended section 535(a) of this Act,
which provides the authorization of appropriations for this part, by
striking ``1991 through 1994'' and inserting ``2001 through 2003''.
Such Public Law did not conform the reference in section 521 above.
---------------------------------------------------------------------------
SEC. 522. [290CC-22] PURPOSE OF GRANTS.
(a) In General.--The Secretary may not make payments under
section 521 unless the State involved agrees that the payments
will be expended solely for making grants to political
subdivisions of the State, and to nonprofit private entities
(including community-based veterans organizations and other
community organizations), for the purpose of providing the
services specified in subsection (b) to individuals who--
(1)(A) are suffering from serious mental illness;
or
(B) are suffering from serious mental illness and
from substance abuse; and
(2) are homeless or at imminent risk of becoming
homeless.
(b) Specification of Services.--The services referred to in
subsection (a) are--
(1) outreach services;
(2) screening and diagnostic treatment services;
(3) habilitation and rehabilitation services;
(4) community mental health services;
(5) alcohol or drug treatment services;
(6) staff training, including the training of
individuals who work in shelters, mental health
clinics, substance abuse programs, and other sites
where homeless individuals require services;
(7) case management services, including--
(A) preparing a plan for the provision of
community mental health services to the
eligible homeless individual involved, and
reviewing such plan not less than once every 3
months;
(B) providing assistance in obtaining and
coordinating social and maintenance services
for the eligible homeless individuals,
including services relating to daily living
activities, personal financial planning,
transportation services, and habilitation and
rehabilitation services, prevocational and
vocational services, and housing services;
(C) providing assistance to the eligible
homeless individual in obtaining income support
services, including housing assistance,
supplemental nutrition assistance program
benefits, and supplemental security income
benefits;
(D) referring the eligible homeless
individual for such other services as may be
appropriate; and
(E) providing representative payee services
in accordance with section 1631(a)(2) of the
Social Security Act if the eligible homeless
individual is receiving aid under title XVI of
such act and if the applicant is designated by
the Secretary to provide such services;
(8) supportive and supervisory services in
residential settings;
(9) referrals for primary health services, job
training, educational services, and relevant housing
services;
(10) subject to subsection (h)(1)--
(A) minor renovation, expansion, and repair
of housing;
(B) planning of housing;
(C) technical assistance in applying for
housing assistance;
(D) improving the coordination of housing
services;
(E) security deposits;
(F) the costs associated with matching
eligible homeless individuals with appropriate
housing situations; and
(G) 1-time rental payments to prevent
eviction; and
(11) other appropriate services, as determined by
the Secretary.
(c) Coordination.--The Secretary may not make payments
under section 521 unless the State involved agrees to make
grants pursuant to subsection (a) only to entities that have
the capacity to provide, directly or through arrangements, the
services specified in section 522(b), including coordinating
the provision of services in order to meet the needs of
eligible homeless individuals who are both mentally ill and
suffering from substance abuse.
(d) Special Consideration Regarding Veterans.--The
Secretary may not make payments under section 521 unless the
State involved agrees that, in making grants to entities
pursuant to subsection (a), the State will give special
consideration to entities with a demonstrated effectiveness in
serving homeless veterans.
(e) Special Rules.--The Secretary may not make payments
under section 521 unless the State involved agrees that grants
pursuant to subsection (a) will not be made to any entity
that--
(1) has a policy of excluding individuals from
mental health services due to the existence or
suspicion of substance abuse; or
(2) has a policy of excluding individuals from
substance abuse services due to the existence or
suspicion of mental illness.
(f) Administrative Expenses.--The Secretary may not make
payments under section 521 unless the State involved agrees
that not more than 4 percent of the payments will be expended
for administrative expenses regarding the payments.
(g) Maintenance of Effort.--The Secretary may not make
payments under section 521 unless the State involved agrees
that the State will maintain State expenditures for services
specified in subsection (b) at a level that is not less than
the average level of such expenditures maintained by the State
for the 2-year period preceding the fiscal year for which the
State is applying to receive such payments.
(h) Restrictions on Use of Funds.--The Secretary may not
make payments under section 521 unless the State involved
agrees that--
(1) not more than 20 percent of the payments will
be expended for housing services under subsection
(b)(10); and
(2) the payments will not be expended--
(A) to support emergency shelters or
construction of housing facilities;
(B) for inpatient psychiatric treatment
costs or inpatient substance abuse treatment
costs; or
(C) to make cash payments to intended
recipients of mental health or substance abuse
services.
(i) Waiver for Territories.--With respect to the United
States Virgin Islands, Guam, American Samoa, Palau, the
Marshall Islands, and the Commonwealth of the Northern Mariana
Islands, the Secretary may waive the provisions of this part
that the Secretary determines to be appropriate.
SEC. 523. [290CC-23] REQUIREMENT OF MATCHING FUNDS.
(a) In General.--The Secretary may not make payments under
section 521 unless, with respect to the costs of providing
services pursuant to section 522, the State involved agrees to
make available, directly or through donations from public or
private entities, non-Federal contributions toward such costs
in an amount that is not less than $1 for each $3 of Federal
funds provided in such payments.
(b) Determination of Amount.--Non-Federal contributions
required in subsection (a) may be in cash or in kind, fairly
evaluated, including plant, equipment, or services. Amounts
provided by the Federal Government, or services assisted or
subsidized to any significant extent by the Federal Government,
shall not be included in determining the amount of such non-
Federal contributions.
(c) Limitation Regarding Grants by States.--The Secretary
may not make payments under section 521 unless the State
involved agrees that the State will not require the entities to
which grants are provided pursuant to section 522(a) to provide
non-Federal contributions in excess of the non-Federal
contributions described in subsection (a).
SEC. 524. [290CC-24] DETERMINATION OF AMOUNT OF ALLOTMENT.
(a) Minimum Allotment.--The allotment for a State under
section 521 for a fiscal year shall be the greater of--
(1) $300,000 for each of the several States, the
District of Columbia, and the Commonwealth of Puerto
Rico, and $50,000 for each of Guam, the Virgin Islands,
American Samoa, and the Commonwealth of the Northern
Mariana Islands; and
(2) an amount determined in accordance with
subsection (b).
(b) Determination Under Formula.--The amount referred to in
subsection (a)(2) is the product of--
(1) an amount equal to the amount appropriated
under section 535(a) for the fiscal year; and
(2) a percentage equal to the quotient of--
(A) an amount equal to the population
living in urbanized areas of the State
involved, as indicated by the most recent data
collected by the Bureau of the Census; and
(B) an amount equal to the population
living in urbanized areas of the United States,
as indicated by the sum of the respective
amounts determined for the States under
subparagraph (A).
SEC. 525. [290CC-25] CONVERSION TO CATEGORICAL PROGRAM IN EVENT OF
FAILURE OF STATE REGARDING EXPENDITURE OF GRANTS.
(a) In General.--Subject to subsection (c), the Secretary
shall, from the amounts specified in subsection (b), make
grants to public and nonprofit private entities for the purpose
of providing to eligible homeless individuals the services
specified in section 522(b).
(b) \1\ Specification of Funds.--The amounts referred to in
subsection (a) are any amounts made available in appropriations
Acts for allotments under section 521 that are not paid to a
State as a result of--
---------------------------------------------------------------------------
\1\ So in law. Subparagraphs (A) through (C) probably should be
redesignated as paragraphs (1) through (3), respectively. See section
511 of Public Law 104-645 (104 Stat. 4729).
---------------------------------------------------------------------------
(A) the failure of the State to submit an
application under section 529;
(B) the failure of the State, in the
determination of the Secretary, to prepare the
application in accordance with such section or
to submit the application within a reasonable
period of time; or
(C) the State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State.
(c) Requirement of Provision of Services in State
Involved.--With respect to grants under subsection (a), amounts
made available under subsection (b) as a result of the State
involved shall be available only for grants to provide services
in such State.
SEC. 526. [290CC-26] PROVISION OF CERTAIN INFORMATION FROM STATE.
The Secretary may not make payments under section 521 to a
State unless, as part of the application required in section
529, the State submits to the Secretary a statement--
(1) identifying existing programs providing
services and housing to eligible homeless individuals
and identify gaps in the delivery systems of such
programs;
(2) containing a plan for providing services and
housing to eligible homeless individuals, which plan--
(A) describes the coordinated and
comprehensive means of providing services and
housing to homeless individuals; and
(B) includes documentation that suitable
housing for eligible homeless individuals will
accompany the provision of services to such
individuals;
(3) describes the source of the non-Federal
contributions described in section 523;
(4) contains assurances that the non-Federal
contributions described in section 523 will be
available at the beginning of the grant period;
(5) describe any voucher system that may be used to
carry out this part; and
(6) contain such other information or assurances as
the Secretary may reasonably require.
SEC. 527. [290CC-27] DESCRIPTION OF INTENDED EXPENDITURES OF GRANT.
(a) In General.--The Secretary may not make payments under
section 521 unless--
(1) as part of the application required in section
529, the State involved submits to the Secretary a
description of the intended use for the fiscal year of
the amounts for which the State is applying pursuant to
such section;
(2) such description identifies the geographic
areas within the State in which the greatest numbers of
homeless individuals with a need for mental health,
substance abuse, and housing services are located;
(3) such description provides information relating
to the programs and activities to be supported and
services to be provided, including information relating
to coordinating such programs and activities with any
similar programs and activities of public and private
entities; and
(4) the State agrees that such description will be
revised throughout the year as may be necessary to
reflect substantial changes in the programs and
activities assisted by the State pursuant to section
522.
(b) Opportunity for Public Comment.--The Secretary may not
make payments under section 521 unless the State involved
agrees that, in developing and carrying out the description
required in subsection (a), the State will provide public
notice with respect to the description (including any
revisions) and such opportunities as may be necessary to
provide interested persons, such as family members, consumers,
and mental health, substance abuse, and housing agencies, an
opportunity to present comments and recommendations with
respect to the description.
(c) Relationship to State Comprehensive Mental Health
Services Plan.--
(1) In general.--The Secretary may not make
payments under section 521 unless the services to be
provided pursuant to the description required in
subsection (a) are consistent with the State
comprehensive mental health services plan required in
subpart 2 of part B of title XIX.
(2) Special rule.--The Secretary may not make
payments under section 521 unless the services to be
provided pursuant to the description required in
subsection (a) have been considered in the preparation
of, have been included in, and are consistent with, the
State comprehensive mental health services plan
referred to in paragraph (1).
SEC. 528. [290CC-28] REQUIREMENT OF REPORTS BY STATES.
(a) In General.--The Secretary may not make payments under
section 521 unless the State involved agrees that, by not later
than January 31 of each fiscal year, the State will prepare and
submit to the Secretary a report in such form and containing
such information as the Secretary determines (after
consultation with the Administrator of the Substance Abuse and
Mental Health Services Administration) to be necessary for--
(1) securing a record and a description of the
purposes for which amounts received under section 521
were expended during the preceding fiscal year and of
the recipients of such amounts; and
(2) determining whether such amounts were expended
in accordance with the provisions of this part.
(b) Availability to Public of Reports.--The Secretary may
not make payments under section 521 unless the State involved
agrees to make copies of the reports described in subsection
(a) available for public inspection.
(c) Evaluations by Comptroller General.--The Administrator
of the Substance Abuse and Mental Health Services
Administration shall evaluate at least once every 3 years the
expenditures of grants under this part by eligible entities in
order to ensure that expenditures are consistent with the
provisions of this part, and shall include in such evaluation
recommendations regarding changes needed in program design or
operations.
SEC. 529. [290CC-29] REQUIREMENT OF APPLICATION.
The Secretary may not make payments under section 521
unless the State involved--
(1) submits to the Secretary an application for the
payments containing agreements and information in
accordance with this part;
(2) the agreements are made through certification
from the chief executive officer of the State; and
(3) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this part.
SEC. 530. [290CC-30] TECHNICAL ASSISTANCE.
The Secretary, through \1\ the National Institute of Mental
Health, the National Institute of Alcohol Abuse and Alcoholism,
and the National Institute on Drug Abuse, shall provide
technical assistance to eligible entities in developing
planning and operating programs in accordance with the
provisions of this part.
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\1\ Section 162(2) of Public Law 102-321 (106 Stat. 375) provides
that section 530 is amended by striking out ``through the National''
and all that follows through ``Abuse'' and inserting in lieu thereof
``through the agencies of the Administration''. The amendment cannot be
executed because it does not specify to which instance of the term
``Abuse'' the amendment applies. Additionally, section 163(a)(3) of
such law described an amendment that could not be executed, as the
amendment included instructions to strike ``on Alcohol Abuse'' while
``of Alcohol Abuse'' is the term in section 530. This latter amendment
attempted to insert ``Administrator of the Substance Abuse and Mental
Health Services Administration''. Subsequently, such section 163(a)(3)
was struck by section 2(b)(2) of Public Law 102-352 (106 Stat. 939).
---------------------------------------------------------------------------
SEC. 531. [290CC-31] FAILURE TO COMPLY WITH AGREEMENTS.
(a) Repayment of Payments.--
(1) The Secretary may, subject to subsection (c),
require a State to repay any payments received by the
State under section 521 that the Secretary determines
were not expended by the State in accordance with the
agreements required to be contained in the application
submitted by the State pursuant to section 529.
(2) If a State fails to make a repayment required
in paragraph (1), the Secretary may offset the amount
of the repayment against the amount of any payment due
to be paid to the State under section 521.
(b) Withholding of Payments.--
(1) The Secretary may, subject to subsection (c),
withhold payments due under section 521 if the
Secretary determines that the State involved is not
expending amounts received under such section in
accordance with the agreements required to be contained
in the application submitted by the State pursuant to
section 529.
(2) The Secretary shall cease withholding payments
from a State under paragraph (1) if the Secretary
determines that there are reasonable assurances that
the State will expend amounts received under section
521 in accordance with the agreements referred to in
such paragraph.
(3) The Secretary may not withhold funds under
paragraph (1) from a State for a minor failure to
comply with the agreements referred to in such
paragraph.
(c) Opportunity for Hearing.--Before requiring repayment of
payments under subsection (a)(1), or withholding payments under
subsection (b)(1), the Secretary shall provide to the State an
opportunity for a hearing.
(d) Rule of Construction.--Notwithstanding any other
provision of this part, a State receiving payments under
section 521 may not, with respect to any agreements required to
be contained in the application submitted under section 529, be
considered to be in violation of any such agreements by reason
of the fact that the State, in the regular course of providing
services under section 522(b) to eligible homeless individuals,
incidentally provides services to homeless individuals who are
not eligible homeless individuals.
SEC. 532. [290CC-32] PROHIBITION AGAINST CERTAIN FALSE STATEMENTS.
(a) In General.--
(1) A person may not knowingly make or cause to be
made any false statement or representation of a
material fact in connection with the furnishing of
items or services for which amounts may be paid by a
State from payments received by the State under section
521.
(2) A person with knowledge of the occurrence of
any event affecting the right of the person to receive
any amounts from payments made to the State under
section 521 may not conceal or fail to disclose any
such event with the intent of securing such an amount
that the person is not authorized to receive or
securing such an amount in an amount greater than the
amount the person is authorized to receive.
(b) Criminal Penalty for Violation of Prohibition.--Any
person who violates a prohibition established in subsection (a)
may for each violation be fined in accordance with title 18,
United States Code, or imprisoned for not more than 5 years, or
both.
SEC. 533. [290CC-33] NONDISCRIMINATION.
(a) In General.--
(1) Rule of construction regarding certain civil
rights laws.--For the purpose of applying the
prohibitions against discrimination on the basis of age
under the Age Discrimination Act of 1975, on the basis
of handicap under section 504 of the Rehabilitation Act
of 1973, on the basis of sex under title IX of the
Education Amendments of 1972, or on the basis of race,
color, or national origin under title VI of the Civil
Rights Act of 1964, programs and activities funded in
whole or in part with funds made available under
section 521 shall be considered to be programs and
activities receiving Federal financial assistance.
(2) Prohibition.--No person shall on the ground of
sex or religion be excluded from participation in, be
denied the benefits of, or be subjected to
discrimination under, any program or activity funded in
whole or in part with funds made available under
section 521.
(b) Enforcement.--
(1) Referrals to attorney general after notice.--
Whenever the Secretary finds that a State, or an entity
that has received a payment pursuant to section 521,
has failed to comply with a provision of law referred
to in subsection (a)(1), with subsection (a)(2), or
with an applicable regulation (including one prescribed
to carry out subsection (a)(2)), the Secretary shall
notify the chief executive officer of the State and
shall request the chief executive officer to secure
compliance. If within a reasonable period of time, not
to exceed 60 days, the chief executive officer fails or
refuses to secure compliance, the Secretary may--
(A) refer the matter to the Attorney
General with a recommendation that an
appropriate civil action be instituted;
(B) exercise the powers and functions
provided by the Age Discrimination Act of 1975,
section 504 of the Rehabilitation Act of 1973,
title IX of the Education Amendments of 1972,
or title VI of the Civil Rights Act of 1964, as
may be applicable; or
(C) take such other actions as may be
authorized by law.
(2) Authority of attorney general.--When a matter
is referred to the Attorney General pursuant to
paragraph (1)(A), or whenever the Attorney General has
reason to believe that a State or an entity is engaged
in a pattern or practice in violation of a provision of
law referred to in subsection (a)(1) or in violation of
subsection (a)(2), the Attorney General may bring a
civil action in any appropriate district court of the
United States for such relief as may be appropriate,
including injunctive relief.
SEC. 534. [290CC-34] DEFINITIONS.
For purposes of this part:
(1) Eligible homeless individual.--The term
``eligible homeless individual'' means an individual
described in section 522(a).
(2) Homeless individual.--The term ``homeless
individual'' has the meaning given such term in section
330(h)(5).
(3) State.--The term ``State'' means each of the
several States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam,
American Samoa, and the Commonwealth of the Northern
Mariana Islands.
(4) Substance abuse.--The term ``substance abuse''
means the abuse of alcohol or other drugs.
SEC. 535. [290CC-35] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this part, there is authorized to be appropriated
$75,000,000 for each of the fiscal years 2001 through 2003.
(b) Effect of Insufficient Appropriations for Minimum
Allotments.--
(1) In general.--If the amounts made available
under subsection (a) for a fiscal year are insufficient
for providing each State with an allotment under
section 521 of not less than the applicable amount
under section 524(a)(1), the Secretary shall, from such
amounts as are made available under such subsection,
make grants to the States for providing to eligible
homeless individuals the services specified in section
522(b).
(2) Rule of construction.--Paragraph (1) may not be
construed to require the Secretary to make a grant
under such paragraph to each State.
Part D--Miscellaneous Provisions Relating to Substance Abuse and Mental
Health
SEC. 541. [290DD] SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
(a) Programs and Services.--
(1) Development.--The Secretary, acting through the
Administrator of the Substance Abuse and Mental Health
Services Administration, shall be responsible for
fostering substance abuse prevention and treatment
programs and services in State and local governments
and in private industry.
(2) Model programs.--
(A) In general.--Consistent with the
responsibilities described in paragraph (1),
the Secretary, acting through the Administrator
of the Substance Abuse and Mental Health
Services Administration, shall develop a
variety of model programs suitable for
replication on a cost-effective basis in
different types of business concerns and State
and local governmental entities.
(B) Dissemination of information.--The
Secretary, acting through the Administrator of
the Substance Abuse and Mental Health Services
Administration, shall disseminate information
and materials relative to such model programs
to the State agencies responsible for the
administration of substance abuse prevention,
treatment, and rehabilitation activities and
shall, to the extent feasible provide technical
assistance to such agencies as requested.
(b) Deprivation of Employment.--
(1) Prohibition.--No person may be denied or
deprived of Federal civilian employment or a Federal
professional or other license or right solely on the
grounds of prior substance abuse.
(2) Application.--This subsection shall not apply
to employment in--
(A) the Central Intelligence Agency;
(B) the Federal Bureau of Investigation;
(C) the National Security Agency;
(D) any other department or agency of the
Federal Government designated for purposes of
national security by the President; or
(E) in any position in any department or
agency of the Federal Government, not referred
to in subparagraphs (A) through (D), which
position is determined pursuant to regulations
prescribed by the head of such agency or
department to be a sensitive position.
(3) Rehabilitation Act.--The inapplicability of the
prohibition described in paragraph (1) to the
employment described in paragraph (2) shall not be
construed to reflect on the applicability of the
Rehabilitation Act of 1973 or other anti-discrimination
laws to such employment.
(c) Construction.--This section shall not be construed to
prohibit the dismissal from employment of a Federal civilian
employee who cannot properly function in his employment.
SEC. 542. [290DD-1] ADMISSION OF SUBSTANCE ABUSERS TO PRIVATE AND
PUBLIC HOSPITALS AND OUTPATIENT FACILITIES.
(a) Nondiscrimination.--Substance abusers who are suffering
from medical conditions shall not be discriminated against in
admission or treatment, solely because of their substance
abuse, by any private or public general hospital, or outpatient
facility (as defined in section 1624(4)) which receives support
in any form from any program supported in whole or in part by
funds appropriated to any Federal department or agency.
(b) Regulations.--
(1) In general.--The Secretary shall issue
regulations for the enforcement of the policy of
subsection (a) with respect to the admission and
treatment of substance abusers in hospitals and
outpatient facilities which receive support of any kind
from any program administered by the Secretary. Such
regulations shall include procedures for determining
(after opportunity for a hearing if requested) if a
violation of subsection (a) has occurred, notification
of failure to comply with such subsection, and
opportunity for a violator to comply with such
subsection. If the Secretary determines that a hospital
or outpatient facility subject to such regulations has
violated subsection (a) and such violation continues
after an opportunity has been afforded for compliance,
the Secretary may suspend or revoke, after opportunity
for a hearing, all or part of any support of any kind
received by such hospital from any program administered
by the Secretary. The Secretary may consult with the
officials responsible for the administration of any
other Federal program from which such hospital or
outpatient facility receives support of any kind, with
respect to the suspension or revocation of such other
Federal support for such hospital or outpatient
facility.
(2) Department of veterans affairs.--The Secretary
of Veterans Affairs, acting through the Under Secretary
for Health, shall, to the maximum feasible extent
consistent with their responsibilities under title 38,
United States Code, prescribe regulations making
applicable the regulations prescribed by the Secretary
under paragraph (1) to the provision of hospital care,
nursing home care, domiciliary care, and medical
services under such title 38 to veterans suffering from
substance abuse. In prescribing and implementing
regulations pursuant to this paragraph, the Secretary
shall, from time to time, consult with the Secretary of
Health and Human Services in order to achieve the
maximum possible coordination of the regulations, and
the implementation thereof, which they each prescribe.
SEC. 543. [290DD-2] CONFIDENTIALITY OF RECORDS.
(a) Requirement.--Records of the identity, diagnosis,
prognosis, or treatment of any patient which are maintained in
connection with the performance of any program or activity
relating to substance abuse education, prevention, training,
treatment, rehabilitation, or research, which is conducted,
regulated, or directly or indirectly assisted by any department
or agency of the United States shall, except as provided in
subsection (e), be confidential and be disclosed only for the
purposes and under the circumstances expressly authorized under
subsection (b).
(b) Permitted Disclosure.--
(1) Consent.--The content of any record referred to
in subsection (a) may be disclosed in accordance with
the prior written consent of the patient with respect
to whom such record is maintained, but only to such
extent, under such circumstances, and for such purposes
as may be allowed under regulations prescribed pursuant
to subsection (g).
(2) Method for disclosure.--Whether or not the
patient, with respect to whom any given record referred
to in subsection (a) is maintained, gives written
consent, the content of such record may be disclosed as
follows:
(A) To medical personnel to the extent
necessary to meet a bona fide medical
emergency.
(B) To qualified personnel for the purpose
of conducting scientific research, management
audits, financial audits, or program
evaluation, but such personnel may not
identify, directly or indirectly, any
individual patient in any report of such
research, audit, or evaluation, or otherwise
disclose patient identities in any manner.
(C) If authorized by an appropriate order
of a court of competent jurisdiction granted
after application showing good cause therefor,
including the need to avert a substantial risk
of death or serious bodily harm. In assessing
good cause the court shall weigh the public
interest and the need for disclosure against
the injury to the patient, to the physician-
patient relationship, and to the treatment
services. Upon the granting of such order, the
court, in determining the extent to which any
disclosure of all or any part of any record is
necessary, shall impose appropriate safeguards
against unauthorized disclosure.
(c) Use of Records in Criminal Proceedings.--Except as
authorized by a court order granted under subsection (b)(2)(C),
no record referred to in subsection (a) may be used to initiate
or substantiate any criminal charges against a patient or to
conduct any investigation of a patient.
(d) Application.--The prohibitions of this section continue
to apply to records concerning any individual who has been a
patient, irrespective of whether or when such individual ceases
to be a patient.
(e) Nonapplicability.--The prohibitions of this section do
not apply to any interchange of records--
(1) within the Uniformed Services or within those
components of the Department of Veterans Affairs
furnishing health care to veterans; or
(2) between such components and the Uniformed
Services.
The prohibitions of this section do not apply to the reporting
under State law of incidents of suspected child abuse and
neglect to the appropriate State or local authorities.
(f) Penalties.--Any person who violates any provision of
this section or any regulation issued pursuant to this section
shall be fined in accordance with title 18, United States Code.
(g) Regulations.--Except as provided in subsection (h), the
Secretary shall prescribe regulations to carry out the purposes
of this section. Such regulations may contain such definitions,
and may provide for such safeguards and procedures, including
procedures and criteria for the issuance and scope of orders
under subsection (b)(2)(C), as in the judgment of the Secretary
are necessary or proper to effectuate the purposes of this
section, to prevent circumvention or evasion thereof, or to
facilitate compliance therewith.
(h) Application to Department of Veterans Affairs.--The
Secretary of Veterans Affairs, acting through the Chief Medical
Director, shall, to the maximum feasible extent consistent with
their responsibilities under title 38, United States Code,
prescribe regulations making applicable the regulations
prescribed by the Secretary of Health and Human Services under
subsection (g) of this section to records maintained in
connection with the provision of hospital care, nursing home
care, domiciliary care, and medical services under such title
38 to veterans suffering from substance abuse. In prescribing
and implementing regulations pursuant to this subsection, the
Secretary of Veterans Affairs shall, from time to time, consult
with the Secretary of Health and Human Services in order to
achieve the maximum possible coordination of the regulations,
and the implementation thereof, which they each prescribe.
Part E--Children With Serious Emotional Disturbances
H4 deg.SEC. 561. [290FF] COMPREHENSIVE COMMUNITY MENTAL
HEALTH SERVICES FOR CHILDREN WITH SERIOUS EMOTIONAL
DISTURBANCES.
(a) Grants to Certain Public Entities.--
(1) In general.--The Secretary, acting through the
Director of the Center for Mental Health Services,
shall make grants to public entities for the purpose of
providing comprehensive community mental health
services to children with a serious emotional
disturbance.
(2) Definition of public entity.--For purposes of
this part, the term ``public entity'' means any State,
any political subdivision of a State, and any Indian
tribe or tribal organization (as defined in section
4(b) and section 4(c) of the Indian Self-Determination
and Education Assistance Act).
(b) Considerations in Making Grants.--
(1) Requirement of status as grantee under part b
of title xix.--The Secretary may make a grant under
subsection (a) to a public entity only if--
(A) in the case of a public entity that is
a State, the State is such a grantee under
section 1911;
(B) in the case of a public entity that is
a political subdivision of a State, the State
in which the political subdivision is located
is such a grantee; and
(C) in the case of a public entity that is
an Indian tribe or tribal organization, the
State in which the tribe or tribal organization
is located is such a grantee.
(2) Requirement of status as medicaid provider.--
(A) Subject to subparagraph (B), the
Secretary may make a grant under subsection (a)
only if, in the case of any service under such
subsection that is covered in the State plan
approved under title XIX of the Social Security
Act for the State involved--
(i) the public entity involved will
provide the service directly, and the
entity has entered into a participation
agreement under the State plan and is
qualified to receive payments under
such plan; or
(ii) the public entity will enter
into an agreement with an organization
under which the organization will
provide the service, and the
organization has entered into such a
participation agreement and is
qualified to receive such payments.
(B)(i) In the case of an organization
making an agreement under subparagraph (A)(ii)
regarding the provision of services under
subsection (a), the requirement established in
such subparagraph regarding a participation
agreement shall be waived by the Secretary if
the organization does not, in providing health
or mental health services, impose a charge or
accept reimbursement available from any third-
party payor, including reimbursement under any
insurance policy or under any Federal or State
health benefits program.
(ii) A determination by the Secretary of
whether an organization referred to in clause
(i) meets the criteria for a waiver under such
clause shall be made without regard to whether
the organization accepts voluntary donations
regarding the provision of services to the
public.
(3) Certain considerations.--In making grants under
subsection (a), the Secretary shall--
(A) equitably allocate such assistance
among the principal geographic regions of the
United States;
(B) consider the extent to which the public
entity involved has a need for the grant; and
(C) in the case of any public entity that
is a political subdivision of a State or that
is an Indian tribe or tribal organization--
(i) shall consider any comments
regarding the application of the entity
for such a grant that are received by
the Secretary from the State in which
the entity is located; and
(ii) shall give special
consideration to the entity if the
State agrees to provide a portion of
the non-Federal contributions required
in subsection (c) regarding such a
grant.
(c) Matching Funds.--
(1) In general.--A funding agreement for a grant
under subsection (a) is that the public entity involved
will, with respect to the costs to be incurred by the
entity in carrying out the purpose described in such
subsection, make available (directly or through
donations from public or private entities) non-Federal
contributions toward such costs in an amount that--
(A) for the first fiscal year for which the
entity receives payments from a grant under
such subsection, is not less than $1 for each
$3 of Federal funds provided in the grant;
(B) for any second or third such fiscal
year, is not less than $1 for each $3 of
Federal funds provided in the grant;
(C) for any fourth such fiscal year, is not
less than $1 for each $1 of Federal funds
provided in the grant; and
(D) for any fifth and sixth such fiscal
year, is not less than $2 for each $1 of
Federal funds provided in the grant.
(2) Determination of amount contributed.--
(A) Non-Federal contributions required in
paragraph (1) may be in cash or in kind, fairly
evaluated, including plant, equipment, or
services. Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of such non-Federal contributions.
(B) In making a determination of the amount
of non-Federal contributions for purposes of
subparagraph (A), the Secretary may include
only non-Federal contributions in excess of the
average amount of non-Federal contributions
made by the public entity involved toward the
purpose described in subsection (a) for the 2-
year period preceding the first fiscal year for
which the entity receives a grant under such
section.
H4 deg.SEC. 562. [290FF-1] REQUIREMENTS WITH RESPECT TO
CARRYING OUT PURPOSE OF GRANTS.
(a) Systems of Comprehensive Care.--
(1) In general.--A funding agreement for a grant
under section 561(a) is that, with respect to children
with a serious emotional disturbance, the public entity
involved will carry out the purpose described in such
section only through establishing and operating 1 or
more systems of care for making each of the mental
health services specified in subsection (c) available
to each child provided access to the system. In
providing for such a system, the public entity may make
grants to, and enter into contracts with, public and
nonprofit private entities.
(2) Structure of system.--A funding agreement for a
grant under section 561(a) is that a system of care
under paragraph (1) will--
(A) be established in a community selected
by the public entity involved;
(B) consist of such public agencies and
nonprofit private entities in the community as
are necessary to ensure that each of the
services specified in subsection (c) is
available to each child provided access to the
system;
(C) be established pursuant to agreements
that the public entity enters into with the
agencies and entities described in subparagraph
(B);
(D) coordinate the provision of the
services of the system; and
(E) establish an office whose functions are
to serve as the location through which children
are provided access to the system, to
coordinate the provision of services of the
system, and to provide information to the
public regarding the system.
(3) Collaboration of local public entities.--A
funding agreement for a grant under section 561(a) is
that, for purposes of the establishment and operation
of a system of care under paragraph (1), the public
entity involved will seek collaboration among all
public agencies that provide human services in the
community in which the system is established, including
but not limited to those providing mental health
services, educational services, child welfare services,
or juvenile justice services.
(b) Limitation on Age of Children Provided Access to
System.--A funding agreement for a grant under section 561(a)
is that a system of care under subsection (a) will not provide
an individual with access to the system if the individual is
more than 21 years of age.
(c) Required Mental Health Services of System.--A funding
agreement for a grant under section 561(a) is that mental
health services provided by a system of care under subsection
(a) will include, with respect to a serious emotional
disturbance in a child--
(1) diagnostic and evaluation services;
(2) outpatient services provided in a clinic,
office, school or other appropriate location, including
individual, group and family counseling services,
professional consultation, and review and management of
medications;
(3) emergency services, available 24-hours a day, 7
days a week;
(4) intensive home-based services for children and
their families when the child is at imminent risk of
out-of-home placement;
(5) intensive day-treatment services;
(6) respite care;
(7) therapeutic foster care services, and services
in therapeutic foster family homes or individual
therapeutic residential homes, and groups homes caring
for not more than 10 children; and
(8) assisting the child in making the transition
from the services received as a child to the services
to be received as an adult.
(d) Required Arrangements Regarding Other Appropriate
Services.--
(1) In general.--A funding agreement for a grant
under section 561(a) is that--
(A) a system of care under subsection (a)
will enter into a memorandum of understanding
with each of the providers specified in
paragraph (2) in order to facilitate the
availability of the services of the provider
involved to each child provided access to the
system; and
(B) the grant under such section 561(a),
and the non-Federal contributions made with
respect to the grant, will not be expended to
pay the costs of providing such non-mental
health services to any individual.
(2) Specification of non-mental health services.--
The providers referred to in paragraph (1) are
providers of medical services other than mental health
services, providers of educational services, providers
of vocational counseling and vocational rehabilitation
services, and providers of protection and advocacy
services with respect to mental health.
(3) Facilitation of services of certain programs.--
A funding agreement for a grant under section 561(a) is
that a system of care under subsection (a) will, for
purposes of paragraph (1), enter into a memorandum of
understanding regarding facilitation of--
(A) services available pursuant to title
XIX of the Social Security Act, including
services regarding early periodic screening,
diagnosis, and treatment;
(B) services available under parts B and C
of the Individuals with Disabilities Education
Act; and
(C) services available under other
appropriate programs, as identified by the
Secretary.
(e) General Provisions Regarding Services of System.--
(1) Case management services.--A funding agreement
for a grant under section 561(a) is that a system of
care under subsection (a) will provide for the case
management of each child provided access to the system
in order to ensure that--
(A) the services provided through the
system to the child are coordinated and that
the need of each such child for the services is
periodically reassessed;
(B) information is provided to the family
of the child on the extent of progress being
made toward the objectives established for the
child under the plan of services implemented
for the child pursuant to section 563; and
(C) the system provides assistance with
respect to--
(i) establishing the eligibility of
the child, and the family of the child,
for financial assistance and services
under Federal, State, or local programs
providing for health services, mental
health services, educational services,
social services, or other services; and
(ii) seeking to ensure that the
child receives appropriate services
available under such programs.
(2) Other provisions.--A funding agreement for a
grant under section 561(a) is that a system of care
under subsection (a), in providing the services of the
system, will--
(A) provide the services of the system in
the cultural context that is most appropriate
for the child and family involved;
(B) ensure that individuals providing such
services to the child can effectively
communicate with the child and family in the
most direct manner;
(C) provide the services without
discriminating against the child or the family
of the child on the basis of race, religion,
national origin, sex, disability, or age;
(D) seek to ensure that each child provided
access to the system of care remains in the
least restrictive, most normative environment
that is clinically appropriate; and
(E) provide outreach services to inform
individuals, as appropriate, of the services
available from the system, including
identifying children with a serious emotional
disturbance who are in the early stages of such
disturbance.
(3) Rule of construction.--An agreement made under
paragraph (2) may not be construed--
(A) with respect to subparagraph (C) of
such paragraph--
(i) to prohibit a system of care
under subsection (a) from requiring
that, in housing provided by the
grantee for purposes of residential
treatment services authorized under
subsection (c), males and females be
segregated to the extent appropriate in
the treatment of the children involved;
or
(ii) to prohibit the system of care
from complying with the agreement made
under subsection (b); or
(B) with respect to subparagraph (D) of
such paragraph, to authorize the system of care
to expend the grant under section 561(a) (or
the non-Federal contributions made with respect
to the grant) to provide legal services or any
service with respect to which expenditures
regarding the grant are prohibited under
subsection (d)(1)(B).
(f) Restrictions on Use of Grant.--A funding agreement for
a grant under section 561(a) is that the grant, and the non-
Federal contributions made with respect to the grant, will not
be expended--
(1) to purchase or improve real property (including
the construction or renovation of facilities);
(2) to provide for room and board in residential
programs serving 10 or fewer children;
(3) to provide for room and board or other services
or expenditures associated with care of children in
residential treatment centers serving more than 10
children or in inpatient hospital settings, except
intensive home-based services and other services
provided on an ambulatory or outpatient basis; or
(4) to provide for the training of any individual,
except training authorized in section 564(a)(2) and
training provided through any appropriate course in
continuing education whose duration does not exceed 2
days.
(g) Waivers.--The Secretary may waive one or more of the
requirements of subsection (c) for a public entity that is an
Indian Tribe or tribal organization, or American Samoa, Guam,
the Marshall Islands, the Federated States of Micronesia, the
Commonwealth of the Northern Mariana Islands, the Republic of
Palau, or the United States Virgin Islands if the Secretary
determines, after peer review, that the system of care is
family-centered and uses the least restrictive environment that
is clinically appropriate.
H4 deg.SEC. 563. [290FF-2] INDIVIDUALIZED PLAN FOR SERVICES.
(a) In General.--A funding agreement for a grant under
section 561(a) is that a system of care under section 562(a)
will develop and carry out an individualized plan of services
for each child provided access to the system, and that the plan
will be developed and carried out with the participation of the
family of the child and, unless clinically inappropriate, with
the participation of the child.
(b) Multidisciplinary Team.--A funding agreement for a
grant under section 561(a) is that the plan required in
subsection (a) will be developed, and reviewed and as
appropriate revised not less than once each year, by a
multidisciplinary team of appropriately qualified individuals
who provide services through the system, including as
appropriate mental health services, other health services,
educational services, social services, and vocational
counseling and rehabilitation; \1\
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\1\ So in law. See section 119 of Public Law 102-321 (106 Stat.
349). Probably should be a period.
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(c) Coordination With Services Under Individuals with
Disabilities Education Act.--A funding agreement for a grant
under section 561(a) is that, with respect to a plan under
subsection (a) for a child, the multidisciplinary team required
in subsection (b) will--
(1) in developing, carrying out, reviewing, and
revising the plan consider any individualized education
program in effect for the child pursuant to part B of
the Individuals with Disabilities Education Act;
(2) ensure that the plan is consistent with such
individualized education program and provides for
coordinating services under the plan with services
under such program; and
(3) ensure that the memorandum of understanding
entered into under section 562(d)(3)(B) regarding such
Act includes provisions regarding compliance with this
subsection.
(d) Contents of Plan.--A funding agreement for a grant
under section 561(a) is that the plan required in subsection
(a) for a child will--
(1) identify and state the needs of the child for
the services available pursuant to section 562 through
the system;
(2) provide for each of such services that is
appropriate to the circumstances of the child,
including, except in the case of children who are less
than 14 years of age, the provision of appropriate
vocational counseling and rehabilitation, and
transition services (as defined in section 602 of the
Individuals with Disabilities Education Act);
(3) establish objectives to be achieved regarding
the needs of the child and the methodology for
achieving the objectives; and
(4) designate an individual to be responsible for
providing the case management required in section
562(e)(1) or certify that case management services will
be provided to the child as part of the individualized
education program of the child under the Individuals
with Disabilities Education Act.
H4 deg.SEC. 564. [290FF-3] ADDITIONAL PROVISIONS.
(a) Optional Services.--In addition to services described
in subsection (c) of section 562, a system of care under
subsection (a) of such section may, in expending a grant under
section 561(a), provide for--
(1) preliminary assessments to determine whether a
child should be provided access to the system;
(2) training in--
(A) the administration of the system;
(B) the provision of intensive home-based
services under paragraph (4) of section 562(c),
intensive day treatment under paragraph (5) of
such section, and foster care or group homes
under paragraph (7) of such section; and
(C) the development of individualized plans
for purposes of section 563;
(3) recreational activities for children provided
access to the system; and
(4) such other services as may be appropriate in
providing for the comprehensive needs with respect to
mental health of children with a serious emotional
disturbance.
(b) Comprehensive Plan.--The Secretary may make a grant
under section 561(a) only if, with respect to the jurisdiction
of the public entity involved, the entity has submitted to the
Secretary, and has had approved by the Secretary, a plan for
the development of a jurisdiction-wide system of care for
community-based services for children with a serious emotional
disturbance that specifies the progress the public entity has
made in developing the jurisdiction-wide system, the extent of
cooperation across agencies serving children in the
establishment of the system, the Federal and non-Federal
resources currently committed to the establishment of the
system, and the current gaps in community services and the
manner in which the grant under section 561(a) will be expended
to address such gaps and establish local systems of care.
(c) Limitation on Imposition of Fees for Services.--A
funding agreement for a grant under section 561(a) is that, if
a charge is imposed for the provision of services under the
grant, such charge--
(1) will be made according to a schedule of charges
that is made available to the public;
(2) will be adjusted to reflect the income of the
family of the child involved; and
(3) will not be imposed on any child whose family
has income and resources of equal to or less than 100
percent of the official poverty line, as established by
the Director of the Office of Management and Budget and
revised by the Secretary in accordance with section
673(2) of the Omnibus Budget Reconciliation Act of
1981.
(d) Relationship to Items and Services Under Other
Programs.--A funding agreement for a grant under section 561(a)
is that the grant, and the non-Federal contributions made with
respect to the grant, will not be expended to make payment for
any item or service to the extent that payment has been made,
or can reasonably be expected to be made, with respect to such
item or service--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(2) by an entity that provides health services on a
prepaid basis.
(e) Limitation on Administrative Expenses.--A funding
agreement for a grant under section 561(a) is that not more
than 2 percent of the grant will be expended for administrative
expenses incurred with respect to the grant by the public
entity involved.
(f) Reports to Secretary.--A funding agreement for a grant
under section 561(a) is that the public entity involved will
annually submit to the Secretary a report on the activities of
the entity under the grant that includes a description of the
number of children provided access to systems of care operated
pursuant to the grant, the demographic characteristics of the
children, the types and costs of services provided pursuant to
the grant, the availability and use of third-party
reimbursements, estimates of the unmet need for such services
in the jurisdiction of the entity, and the manner in which the
grant has been expended toward the establishment of a
jurisdiction-wide system of care for children with a serious
emotional disturbance, and such other information as the
Secretary may require with respect to the grant.
(g) Description of Intended Uses of Grant.--The Secretary
may make a grant under section 561(a) only if--
(1) the public entity involved submits to the
Secretary a description of the purposes for which the
entity intends to expend the grant;
(2) the description identifies the populations,
areas, and localities in the jurisdiction of the entity
with a need for services under this section; and
(3) the description provides information relating
to the services and activities to be provided,
including a description of the manner in which the
services and activities will be coordinated with any
similar services or activities of public or nonprofit
entities.
(h) Requirement of Application.--The Secretary may make a
grant under section 561(a) only if an application for the grant
is submitted to the Secretary, the application contains the
description of intended uses required in subsection (g), and
the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out this section.
H4 deg.SEC. 565. [290FF-4] GENERAL PROVISIONS.
(a) Duration of Support.--The period during which payments
are made to a public entity from a grant under section 561(a)
may not exceed 6 fiscal years.
(b) Technical Assistance.--
(1) In general.--The Secretary shall, upon the
request of a public entity receiving a grant under
section 561(a)--
(A) provide technical assistance to the
entity regarding the process of submitting to
the Secretary applications for grants under
section 561(a); and
(B) provide to the entity training and
technical assistance with respect to the
planning, development, and operation of systems
of care pursuant to section 562.
(2) Authority for grants and contracts.--The
Secretary may provide technical assistance under
subsection (a) directly or through grants to, or
contracts with, public and nonprofit private entities.
(c) Evaluations and Reports by Secretary.--
(1) In general.--The Secretary shall, directly or
through contracts with public or private entities,
provide for annual evaluations of programs carried out
pursuant to section 561(a). The evaluations shall
assess the effectiveness of the systems of care
operated pursuant to such section, including
longitudinal studies of outcomes of services provided
by such systems, other studies regarding such outcomes,
the effect of activities under this part on the
utilization of hospital and other institutional
settings, the barriers to and achievements resulting
from interagency collaboration in providing community-
based services to children with a serious emotional
disturbance, and assessments by parents of the
effectiveness of the systems of care.
(2) Report to congress.--The Secretary shall, not
later than 1 year after the date on which amounts are
first appropriated under subsection (c), and annually
thereafter, submit to the Congress a report summarizing
evaluations carried out pursuant to paragraph (1)
during the preceding fiscal year and making such
recommendations for administrative and legislative
initiatives with respect to this section as the
Secretary determines to be appropriate.
(d) Definitions.--For purposes of this part:
(1) The term ``child'' means an individual not more
than 21 years of age.
(2) The term ``family'', with respect to a child
provided access to a system of care under section
562(a), means--
(A) the legal guardian of the child; and
(B) as appropriate regarding mental health
services for the child, the parents of the
child (biological or adoptive, as the case may
be) and any foster parents of the child.
(3) The term ``funding agreement'', with respect to
a grant under section 561(a) to a public entity, means
that the Secretary may make such a grant only if the
public entity makes the agreement involved.
(4) The term ``serious emotional disturbance''
includes, with respect to a child, any child who has a
serious emotional disorder, a serious behavioral
disorder, or a serious mental disorder.
(e) Rule of Construction.--Nothing in this part shall be
construed as limiting the rights of a child with a serious
emotional disturbance under the Individuals with Disabilities
Education Act.
(f) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out this part, there are authorized
to be appropriated $100,000,000 for fiscal year 2001,
and such sums as may be necessary for each of the
fiscal years 2002 and 2003.
(2) \1\ Limitation regarding technical assistance.--Not
more than 10 percent of the amounts appropriated under
paragraph (1) for a fiscal year may be expended for carrying
out subsection (b).
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\1\ Indentation is so in law. See section 2017(2)(C)(ii) of Public
Law 103-43 (107 Stat. 218).
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Part F--Model Comprehensive Program for Treatment of Substance Abuse
\2\
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\2\ The part designation and heading for part F are so in law. Part
F formerly consisted of section 571. That section was repealed by
section 3301(c)(4) of Public Law 106-310 (114 Stat. 1209), but there
was no conforming amendment to strike the designation and heading for
part F.
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Part G \3\--Projects for Children and Violence
SEC. 581. \3\ [290HH] CHILDREN AND VIOLENCE.
---------------------------------------------------------------------------
\3\ There is another part G in this title, which also begins with a
section 581. See page 677. That part G relates to services provided
through religious organizations.
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(a) In General.--The Secretary, in consultation with the
Secretary of Education and the Attorney General, shall carry
out directly or through grants, contracts or cooperative
agreements with public entities a program to assist local
communities in developing ways to assist children in dealing
with violence.
(b) Activities.--Under the program under subsection (a),
the Secretary may--
(1) provide financial support to enable local
communities to implement programs to foster the health
and development of children;
(2) provide technical assistance to local
communities with respect to the development of programs
described in paragraph (1);
(3) provide assistance to local communities in the
development of policies to address violence when and if
it occurs;
(4) assist in the creation of community
partnerships among law enforcement, education systems
and mental health and substance abuse service systems;
and
(5) establish mechanisms for children and
adolescents to report incidents of violence or plans by
other children or adolescents to commit violence.
(c) Requirements.--An application for a grant, contract or
cooperative agreement under subsection (a) shall demonstrate
that--
(1) the applicant will use amounts received to
create a partnership described in subsection (b)(4) to
address issues of violence in schools;
(2) the activities carried out by the applicant
will provide a comprehensive method for addressing
violence, that will include--
(A) security;
(B) educational reform;
(C) the review and updating of school
policies;
(D) alcohol and drug abuse prevention and
early intervention services;
(E) mental health prevention and treatment
services; and
(F) early childhood development and
psychosocial services; and
(3) the applicant will use amounts received only
for the services described in subparagraphs (D), (E),
and (F) of paragraph (2).
(d) Geographical Distribution.--The Secretary shall ensure
that grants, contracts or cooperative agreements under
subsection (a) will be distributed equitably among the regions
of the country and among urban and rural areas.
(e) Duration of Awards.--With respect to a grant, contract
or cooperative agreement under subsection (a), the period
during which payments under such an award will be made to the
recipient may not exceed 5 years.
(f ) Evaluation.--The Secretary shall conduct an evaluation
of each project carried out under this section and shall
disseminate the results of such evaluations to appropriate
public and private entities.
(g) Information and Education.--The Secretary shall
establish comprehensive information and education programs to
disseminate the findings of the knowledge development and
application under this section to the general public and to
health care professionals.
(h) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $100,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 and 2003.
SEC. 582. [290HH-1] GRANTS TO ADDRESS THE PROBLEMS OF PERSONS WHO
EXPERIENCE VIOLENCE RELATED STRESS.
(a) In General.--The Secretary shall award grants,
contracts or cooperative agreements to public and nonprofit
private entities, as well as to Indian tribes and tribal
organizations, for the purpose of developing programs focusing
on the behavioral and biological aspects of psychological
trauma response and for developing knowledge with regard to
evidence-based practices for treating psychiatric disorders of
children and youth resulting from witnessing or experiencing a
traumatic event.
(b) Priorities.--In awarding grants, contracts or
cooperative agreements under subsection (a) related to the
development of knowledge on evidence-based practices for
treating disorders associated with psychological trauma, the
Secretary shall give priority to mental health agencies and
programs that have established clinical and basic research
experience in the field of trauma-related mental disorders.
(c) Geographical Distribution.--The Secretary shall ensure
that grants, contracts or cooperative agreements under
subsection (a) with respect to centers of excellence are
distributed equitably among the regions of the country and
among urban and rural areas.
(d) Evaluation.--The Secretary, as part of the application
process, shall require that each applicant for a grant,
contract or cooperative agreement under subsection (a) submit a
plan for the rigorous evaluation of the activities funded under
the grant, contract or agreement, including both process and
outcomes evaluation, and the submission of an evaluation at the
end of the project period.
(e) Duration of Awards.--With respect to a grant, contract
or cooperative agreement under subsection (a), the period
during which payments under such an award will be made to the
recipient may not exceed 5 years. Such grants, contracts or
agreements may be renewed.
(f ) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $50,000,000 for
fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2003 through 2006.
(g) Short Title.--This section may be cited as the ``Donald
J. Cohen National Child Traumatic Stress Initiative''.
PART H--REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN
FACILITIES
SEC. 591. [290II] REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF
CERTAIN FACILITIES.
(a) In General.--A public or private general hospital,
nursing facility, intermediate care facility, or other health
care facility, that receives support in any form from any
program supported in whole or in part with funds appropriated
to any Federal department or agency shall protect and promote
the rights of each resident of the facility, including the
right to be free from physical or mental abuse, corporal
punishment, and any restraints or involuntary seclusions
imposed for purposes of discipline or convenience.
(b) Requirements.--Restraints and seclusion may only be
imposed on a resident of a facility described in subsection (a)
if--
(1) the restraints or seclusion are imposed to
ensure the physical safety of the resident, a staff
member, or others; and
(2) the restraints or seclusion are imposed only
upon the written order of a physician, or other
licensed practitioner permitted by the State and the
facility to order such restraint or seclusion, that
specifies the duration and circumstances under which
the restraints are to be used (except in emergency
circumstances specified by the Secretary until such an
order could reasonably be obtained).
(c) Current Law.--This part shall not be construed to
affect or impede any Federal or State law or regulations that
provide greater protections than this part regarding seclusion
and restraint.
(d) Definitions.--In this section:
(1) Restraints.--The term ``restraints'' means--
(A) any physical restraint that is a
mechanical or personal restriction that
immobilizes or reduces the ability of an
individual to move his or her arms, legs, or
head freely, not including devices, such as
orthopedically prescribed devices, surgical
dressings or bandages, protective helmets, or
any other methods that involves the physical
holding of a resident for the purpose of
conducting routine physical examinations or
tests or to protect the resident from falling
out of bed or to permit the resident to
participate in activities without the risk of
physical harm to the resident (such term does
not include a physical escort); and
(B) a drug or medication that is used as a
restraint to control behavior or restrict the
resident's freedom of movement that is not a
standard treatment for the resident's medical
or psychiatric condition.
(2) Seclusion.--The term ``seclusion'' means a
behavior control technique involving locked isolation.
Such term does not include a time out.
(3) Physical escort.--The term ``physical escort''
means the temporary touching or holding of the hand,
wrist, arm, shoulder or back for the purpose of
inducing a resident who is acting out to walk to a safe
location.
(4) Time out.--The term ``time out'' means a
behavior management technique that is part of an
approved treatment program and may involve the
separation of the resident from the group, in a non-
locked setting, for the purpose of calming. Time out is
not seclusion.
SEC. 592. [290II-1] REPORTING REQUIREMENT.
(a) In General.--Each facility to which the Protection and
Advocacy for Mentally Ill Individuals Act of 1986 \1\ applies
shall notify the appropriate agency, as determined by the
Secretary, of each death that occurs at each such facility
while a patient is restrained or in seclusion, of each death
occurring within 24 hours after the patient has been removed
from restraints and seclusion, or where it is reasonable to
assume that a patient's death is a result of such seclusion or
restraint. A notification under this section shall include the
name of the resident and shall be provided not later than 7
days after the date of the death of the individual involved.
---------------------------------------------------------------------------
\1\ Probably should be Protection and Advocacy for Individuals with
Mental Illness Act. See section 3206(a) of Public Law 106-310 (114
Stat. 1193).
---------------------------------------------------------------------------
(b) Facility.--In this section, the term ``facility'' has
the meaning given the term ``facilities'' in section 102(3) of
the Protection and Advocacy for Mentally Ill Individuals Act of
1986 \1\ (42 U.S.C. 10802(3)).
SEC. 593. \2\ [290II-3] REGULATIONS AND ENFORCEMENT.
---------------------------------------------------------------------------
\2\ Section 593 appears according to the probable intent of the
Congress. Section 3207 of Public Law 106-310 (114 Stat. 1196) added
sections 591 and 592, and closing quotations were provided at the end
of section 592. Immediately following that section, however, section
593 appeared in quotations, and closing quotations were provided at the
end of the section. The probable intent of the Congress is that closing
quotations should not have been provided at the end of section 592.
---------------------------------------------------------------------------
(a) Training.--Not later than 1 year after the date of the
enactment of this part, the Secretary, after consultation with
appropriate State and local protection and advocacy
organizations, physicians, facilities, and other health care
professionals and patients, shall promulgate regulations that
require facilities to which the Protection and Advocacy for
Mentally Ill Individuals Act of 1986 \1\ (42 U.S.C. 10801 et
seq.) applies, to meet the requirements of subsection (b).
---------------------------------------------------------------------------
\1\ See footnote for subsection (a).
---------------------------------------------------------------------------
(b) Requirements.--The regulations promulgated under
subsection (a) shall require that--
(1) facilities described in subsection (a) ensure
that there is an adequate number of qualified
professional and supportive staff to evaluate patients,
formulate written individualized, comprehensive
treatment plans, and to provide active treatment
measures;
(2) appropriate training be provided for the staff
of such facilities in the use of restraints and any
alternatives to the use of restraints; and
(3) such facilities provide complete and accurate
notification of deaths, as required under section
592(a).
(c) Enforcement.--A facility to which this part applies
that fails to comply with any requirement of this part,
including a failure to provide appropriate training, shall not
be eligible for participation in any program supported in whole
or in part by funds appropriated to any Federal department or
agency.
PART I--REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON-
MEDICAL, COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH
SEC. 595. [290JJ] REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF
CERTAIN NON-MEDICAL, COMMUNITY-BASED FACILITIES FOR
CHILDREN AND YOUTH.
(a) Protection of Rights.--
(1) In general.--A public or private non-medical,
community-based facility for children and youth (as
defined in regulations to be promulgated by the
Secretary) that receives support in any form from any
program supported in whole or in part with funds
appropriated under this Act shall protect and promote
the rights of each resident of the facility, including
the right to be free from physical or mental abuse,
corporal punishment, and any restraints or involuntary
seclusions imposed for purposes of discipline or
convenience.
(2) Nonapplicability.--Notwithstanding this part, a
facility that provides inpatient psychiatric treatment
services for individuals under the age of 21, as
authorized and defined in subsections (a)(16) and (h)
of section 1905 of the Social Security Act, shall
comply with the requirements of part H.
(3) Applicability of medicaid provisions.--A non-
medical, community-based facility for children and
youth funded under the Medicaid program under title XIX
of the Social Security Act shall continue to meet all
existing requirements for participation in such program
that are not affected by this part.
(b) Requirements.--
(1) In general.--Physical restraints and seclusion
may only be imposed on a resident of a facility
described in subsection (a) if--
(A) the restraints or seclusion are imposed
only in emergency circumstances and only to
ensure the immediate physical safety of the
resident, a staff member, or others and less
restrictive interventions have been determined
to be ineffective; and
(B) the restraints or seclusion are imposed
only by an individual trained and certified, by
a State-recognized body (as defined in
regulation promulgated by the Secretary) and
pursuant to a process determined appropriate by
the State and approved by the Secretary, in the
prevention and use of physical restraint and
seclusion, including the needs and behaviors of
the population served, relationship building,
alternatives to restraint and seclusion, de-
escalation methods, avoiding power struggles,
thresholds for restraints and seclusion, the
physiological and psychological impact of
restraint and seclusion, monitoring physical
signs of distress and obtaining medical
assistance, legal issues, position asphyxia,
escape and evasion techniques, time limits, the
process for obtaining approval for continued
restraints, procedures to address problematic
restraints, documentation, processing with
children, and follow-up with staff, and
investigation of injuries and complaints.
(2) Interim procedures relating to training and
certification.--
(A) In general.--Until such time as the
State develops a process to assure the proper
training and certification of facility
personnel in the skills and competencies
referred in paragraph (1)(B), the facility
involved shall develop and implement an interim
procedure that meets the requirements of
subparagraph (B).
(B) Requirements.--A procedure developed
under subparagraph (A) shall--
(i) ensure that a supervisory or
senior staff person with training in
restraint and seclusion who is
competent to conduct a face-to-face
assessment (as defined in regulations
promulgated by the Secretary), will
assess the mental and physical well-
being of the child or youth being
restrained or secluded and assure that
the restraint or seclusion is being
done in a safe manner;
(ii) ensure that the assessment
required under clause (i) take place as
soon as practicable, but in no case
later than 1 hour after the initiation
of the restraint or seclusion; and
(iii) ensure that the supervisory
or senior staff person continues to
monitor the situation for the duration
of the restraint and seclusion.
(3) Limitations.--
(A) In general.--The use of a drug or
medication that is used as a restraint to
control behavior or restrict the resident's
freedom of movement that is not a standard
treatment for the resident's medical or
psychiatric condition in nonmedical community-
based facilities for children and youth
described in subsection (a)(1) is prohibited.
(B) Prohibition.--The use of mechanical
restraints in non-medical, community-based
facilities for children and youth described in
subsection (a)(1) is prohibited.
(C) Limitation.--A non-medical, community-
based facility for children and youth described
in subsection (a)(1) may only use seclusion
when a staff member is continuously face-to-
face monitoring the resident and when strong
licensing or accreditation and internal
controls are in place.
(c) Rule of Construction.--
(1) In general.--Nothing in this section shall be
construed as prohibiting the use of restraints for
medical immobilization, adaptive support, or medical
protection.
(2) Current law.--This part shall not be construed
to affect or impede any Federal or State law or
regulations that provide greater protections than this
part regarding seclusion and restraint.
(d) Definitions.--In this section:
(1) Mechanical restraint.--The term ``mechanical
restraint'' means the use of devices as a means of
restricting a resident's freedom of movement.
(2) Physical escort.--The term ``physical escort''
means the temporary touching or holding of the hand,
wrist, arm, shoulder or back for the purpose of
inducing a resident who is acting out to walk to a safe
location.
(3) Physical restraint.--The term ``physical
restraint'' means a personal restriction that
immobilizes or reduces the ability of an individual to
move his or her arms, legs, or head freely. Such term
does not include a physical escort.
(4) Seclusion.--The term ``seclusion'' means a
behavior control technique involving locked isolation.
Such term does not include a time out.
(5) Time out.--The term ``time out'' means a
behavior management technique that is part of an
approved treatment program and may involve the
separation of the resident from the group, in a non-
locked setting, for the purpose of calming. Time out is
not seclusion.
SEC. 595A. [290JJ-1] REPORTING REQUIREMENT.
Each facility to which this part applies shall notify the
appropriate State licensing or regulatory agency, as determined
by the Secretary--
(1) of each death that occurs at each such
facility. A notification under this section shall
include the name of the resident and shall be provided
not later than 24 hours after the time of the
individuals death; and
(2) of the use of seclusion or restraints in
accordance with regulations promulgated by the
Secretary, in consultation with the States.
SEC. 595B. [290JJ-2] REGULATIONS AND ENFORCEMENT.
(a) Training.--Not later than 6 months after the date of
the enactment of this part, the Secretary, after consultation
with appropriate State, local, public and private protection
and advocacy organizations, health care professionals, social
workers, facilities, and patients, shall promulgate regulations
that--
(1) require States that license non-medical,
community-based residential facilities for children and
youth to develop licensing rules and monitoring
requirements concerning behavior management practice
that will ensure compliance with Federal regulations
and to meet the requirements of subsection (b);
(2) require States to develop and implement such
licensing rules and monitoring requirements within 1
year after the promulgation of the regulations referred
to in the matter preceding paragraph (1); and
(3) support the development of national guidelines
and standards on the quality, quantity, orientation and
training, required under this part, as well as the
certification or licensure of those staff responsible
for the implementation of behavioral intervention
concepts and techniques.
(b) Requirements.--The regulations promulgated under
subsection (a) shall require--
(1) that facilities described in subsection (a)
ensure that there is an adequate number of qualified
professional and supportive staff to evaluate
residents, formulate written individualized,
comprehensive treatment plans, and to provide active
treatment measures;
(2) the provision of appropriate training and
certification of the staff of such facilities in the
prevention and use of physical restraint and seclusion,
including the needs and behaviors of the population
served, relationship building, alternatives to
restraint, de-escalation methods, avoiding power
struggles, thresholds for restraints, the physiological
impact of restraint and seclusion, monitoring physical
signs of distress and obtaining medical assistance,
legal issues, position asphyxia, escape and evasion
techniques, time limits for the use of restraint and
seclusion, the process for obtaining approval for
continued restraints and seclusion, procedures to
address problematic restraints, documentation,
processing with children, and follow-up with staff, and
investigation of injuries and complaints; and
(3) that such facilities provide complete and
accurate notification of deaths, as required under
section 595A(1).
(c) Enforcement.--A State to which this part applies that
fails to comply with any requirement of this part, including a
failure to provide appropriate training and certification,
shall not be eligible for participation in any program
supported in whole or in part by funds appropriated under this
Act.
Part G \1\--Services Provided Through Religious Organizations \2\
---------------------------------------------------------------------------
\1\ There are two parts G in this title. The first was added by
section 3101 of Public Law 106-310 (114 Stat. 1168) and relates to
projects for children and violence; that part also begins with section
581. See page 669. Sections 3207 and 3208 of such Public Law (114 Stat.
1195, 1197) added parts H and I, respectively.
Subsequently, part G above was added by section 144 of the
Community Renewal Tax Relief Act of 2000 (as enacted into law by
section 1(a)(7) of Public Law 106-554; 114 Stat. 2763A-619), which
provides that title V of this Act ``is amended by adding at the end the
following part:'', thereby placing that part G after the part I added
by Public Law 106-310.
\2\ Section 1955 of this Act also relates to religious
organizations as providers of substance abuse services. That section
was added by section 3305 of Public Law 106-310 (114 Stat. 1212).
---------------------------------------------------------------------------
SEC. 581. \1\ [290KK] APPLICABILITY TO DESIGNATED PROGRAMS.
(a) Designated Programs.--Subject to subsection (b), this
part applies to discretionary and formula grant programs
administered by the Substance Abuse and Mental Health Services
Administration that make awards of financial assistance to
public or private entities for the purpose of carrying out
activities to prevent or treat substance abuse (in this part
referred to as a ``designated program''). Designated programs
include the program under subpart II of part B of title XIX
(relating to formula grants to the States).
(b) Limitation.--This part does not apply to any award of
financial assistance under a designated program for a purpose
other than the purpose specified in subsection (a).
(c) Definitions.--For purposes of this part (and subject to
subsection (b)):
(1) The term ``designated program'' has the meaning
given such term in subsection (a).
(2) The term ``financial assistance'' means a
grant, cooperative agreement, or contract.
(3) The term ``program beneficiary'' means an
individual who receives program services.
(4) The term ``program participant'' means a public
or private entity that has received financial
assistance under a designated program.
(5) The term ``program services'' means treatment
for substance abuse, or preventive services regarding
such abuse, provided pursuant to an award of financial
assistance under a designated program.
(6) The term ``religious organization'' means a
nonprofit religious organization.
SEC. 582. [290KK-1] RELIGIOUS ORGANIZATIONS AS PROGRAM PARTICIPANTS.
(a) In General.--Notwithstanding any other provision of
law, a religious organization, on the same basis as any other
nonprofit private provider--
(1) may receive financial assistance under a
designated program; and
(2) may be a provider of services under a
designated program.
(b) Religious Organizations.--The purpose of this section
is to allow religious organizations to be program participants
on the same basis as any other nonprofit private provider
without impairing the religious character of such
organizations, and without diminishing the religious freedom of
program beneficiaries.
(c) Nondiscrimination Against Religious Organizations.--
(1) Eligibility as program participants.--Religious
organizations are eligible to be program participants
on the same basis as any other nonprofit private
organization as long as the programs are implemented
consistent with the Establishment Clause and Free
Exercise Clause of the First Amendment to the United
States Constitution. Nothing in this Act shall be
construed to restrict the ability of the Federal
Government, or a State or local government receiving
funds under such programs, to apply to religious
organizations the same eligibility conditions in
designated programs as are applied to any other
nonprofit private organization.
(2) Nondiscrimination.--Neither the Federal
Government nor a State or local government receiving
funds under designated programs shall discriminate
against an organization that is or applies to be a
program participant on the basis that the organization
has a religious character.
(d) Religious Character and Freedom.--
(1) Religious organizations.--Except as provided in
this section, any religious organization that is a
program participant shall retain its independence from
Federal, State, and local government, including such
organization's control over the definition,
development, practice, and expression of its religious
beliefs.
(2) Additional safeguards.--Neither the Federal
Government nor a State shall require a religious
organization to--
(A) alter its form of internal governance;
or
(B) remove religious art, icons, scripture,
or other symbols,
in order to be a program participant.
(e) Employment Practices.--Nothing in this section shall be
construed to modify or affect the provisions of any other
Federal or State law or regulation that relates to
discrimination in employment. A religious organization's
exemption provided under section 702 of the Civil Rights Act of
1964 regarding employment practices shall not be affected by
its participation in, or receipt of funds from, a designated
program.
(f ) Rights of Program Beneficiaries.--
(1) In general.--If an individual who is a program
beneficiary or a prospective program beneficiary
objects to the religious character of a program
participant, within a reasonable period of time after
the date of such objection such program participant
shall refer such individual to, and the appropriate
Federal, State, or local government that administers a
designated program or is a program participant shall
provide to such individual (if otherwise eligible for
such services), program services that--
(A) are from an alternative provider that
is accessible to, and has the capacity to
provide such services to, such individual; and
(B) have a value that is not less than the
value of the services that the individual would
have received from the program participant to
which the individual had such objection.
Upon referring a program beneficiary to an alternative
provider, the program participant shall notify the
appropriate Federal, State, or local government agency
that administers the program of such referral.
(2) Notices.--Program participants, public agencies
that refer individuals to designated programs, and the
appropriate Federal, State, or local governments that
administer designated programs or are program
participants shall ensure that notice is provided to
program beneficiaries or prospective program
beneficiaries of their rights under this section.
(3) Additional requirements.--A program participant
making a referral pursuant to paragraph (1) shall--
(A) prior to making such referral, consider
any list that the State or local government
makes available of entities in the geographic
area that provide program services; and
(B) ensure that the individual makes
contact with the alternative provider to which
the individual is referred.
(4) Nondiscrimination.--A religious organization
that is a program participant shall not in providing
program services or engaging in outreach activities
under designated programs discriminate against a
program beneficiary or prospective program beneficiary
on the basis of religion or religious belief.
(g) Fiscal Accountability.--
(1) In general.--Except as provided in paragraph
(2), any religious organization that is a program
participant shall be subject to the same regulations as
other recipients of awards of Federal financial
assistance to account, in accordance with generally
accepted auditing principles, for the use of the funds
provided under such awards.
(2) Limited audit.--With respect to the award
involved, a religious organization that is a program
participant shall segregate Federal amounts provided
under award into a separate account from non-Federal
funds. Only the award funds shall be subject to audit
by the government.
(h) Compliance.--With respect to compliance with this
section by an agency, a religious organization may obtain
judicial review of agency action in accordance with chapter 7
of title 5, United States Code.
SEC. 583. [290KK-2] LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
No funds provided under a designated program shall be
expended for sectarian worship, instruction, or
proselytization.
SEC. 584. [290KK-3] EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG
TREATMENT PROGRAMS.
(a) Findings.--The Congress finds that--
(1) establishing unduly rigid or uniform
educational qualification for counselors and other
personnel in drug treatment programs may undermine the
effectiveness of such programs; and
(2) such educational requirements for counselors
and other personnel may hinder or prevent the provision
of needed drug treatment services.
(b) Nondiscrimination.--In determining whether personnel of
a program participant that has a record of successful drug
treatment for the preceding three years have satisfied State or
local requirements for education and training, a State or local
government shall not discriminate against education and
training provided to such personnel by a religious
organization, so long as such education and training includes
basic content substantially equivalent to the content provided
by nonreligious organizations that the State or local
government would credit for purposes of determining whether the
relevant requirements have been satisfied.
TITLE VI--ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS
AND OTHER MEDICAL FACILITIES
declaration of purpose
Sec. 600. [291] The purpose of this title is--
(a) to assist the several States in the carrying
out of their programs for the construction and
modernization of such public or other nonprofit
community hospitals and other medical facilities as may
be necessary, in conjunction with existing facilities,
to furnish adequate hospital, clinic, or similar
services to all their people;
(b) to stimulate the development of new or improved
types of physical facilities for medical, diagnostic,
preventive, treatment, or rehabilitative services; and
(c) to promote research, experiments, and
demonstrations relating to the effective development
and utilization of hospital, clinic, or similar
services, facilities, and resources, and to promote the
coordination of such research, experiments, and
demonstrations and the useful application of their
results.
Part A--Grants and Loans for Construction and Modernization of
Hospitals and Other Medical Facilities
authorization of appropriations for construction and modernization
grants
Sec. 601. [291a] In order to assist the States in carrying
out the purposes of section 600, there are authorized to be
appropriated--
(a) for the fiscal year ending June 30, 1974--
(1) $20,800,000 for grants for the construction of
public or other nonprofit facilities for long-term
care;
(2) $70,000,000 for grants for the construction of
public or other nonprofit outpatient facilities;
(3) $15,000,000 for grants for the construction of
public or other nonprofit rehabilitation facilities;
(b) for grants for the construction of public or other
nonprofit hospitals and public health centers, $150,000,000 for
the fiscal year ending June 30, 1965, $160,000,000 for the
fiscal year ending June 30, 1966, $170,000,000 for the fiscal
year ending June 30, 1967, $180,000,000 each for the next two
fiscal years, $195,000,000 for the fiscal year ending June 30,
1970, $147,500,000 for the fiscal year ending June 30, 1971,
$152,500,000 for the fiscal year ending June 30, 1972,
$157,500,000 for the fiscal year ending June 30, 1973, and
$41,400,000 for the fiscal year ending June 30, 1974; and
(c) for grants for modernization of the facilities referred
to in paragraphs (a) and (b), $65,000,000 for the fiscal year
ending June 30, 1971, $80,000,000 for the fiscal year ending
June 30, 1972, $90,000,000 for the fiscal year ending June 30,
1973, and $50,000,000 for the fiscal year ending June 30, 1974.
state allotments
Sec. 602. [291b] (a)(1) Each State shall be entitled for
each fiscal year to an allotment bearing the same ratio to the
sums appropriated for such year pursuant to subparagraphs (1),
(2), and (3), respectively, of section 601(a), and to an
allotment bearing the same ratio to the sums appropriated for
such year pursuant to section 601(b), as the product of--
(A) the population of such State, and
(B) the square of its allotment percentage,
bears to the sum of the corresponding products for all of the
States.
(2) For each fiscal year, the Secretary shall, in
accordance with regulations, make allotments among the States,
from the sums appropriated for such year under section 601(c),
on the basis of the population, the financial need, and the
extent of the need for modernization of the facilities referred
to in paragraphs (a) and (b) of section 601, of the respective
States.
(b)(1) The allotment to any State under subsection (a) for
any fiscal year which is less than--
(A) $50,000 for the Virgin Islands, American Samoa,
the Trust Territory of the Pacific Islands, or Guam and
$100,000 for any other State, in the case of an
allotment for grants for the construction of public or
other nonprofit rehabilitation facilities.
(B) $100,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or
Guam and $200,000 for any other State in the case of an
allotment for grants for the construction of public or
other nonprofit outpatient facilities.
(C) $200,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or
Guam and $300,000 for any other State in the case of an
allotment for grants for the construction of public or
other nonprofit facilities for long-term care or for
the construction of public or other nonprofit hospitals
and public health centers, or for the modernization of
facilities referred to in paragraph (a) or (b) of
section 601, or
(D) $200,000 for the Virgin Islands, American
Samoa, the Trust Territory of the Pacific Islands, or
Guam and $300,000 for any other State in the case of an
allotment for grants for the modernization of
facilities referred to in paragraphs (a) and (b) of
section 601,
shall be increased to that amount, the total of the increases
thereby required being derived by proportionately reducing the
allotment from appropriations under such subparagraph or
paragraph to each of the remaining States under subsection (a)
of this section, but with such adjustments as may be necessary
to prevent the allotment of any of such remaining States from
appropriations under such subparagraph or paragraph from being
thereby reduced to less than that amount.
(2) An allotment of the Virgin Islands, American Samoa, the
Trust Territory of the Pacific Islands, or Guam for any fiscal
year may be increased as provided in paragraph (1) only to the
extent it satisfies the Surgeon General, at such time prior to
the beginning of such year as the Surgeon General may
designate, that such increase will be used for payments under
and in accordance with the provisions of this part.
(c) For the purposes of this part--
(1) The ``allotment percentage'' for any State
shall be 100 per centum less that percentage which
bears the same ratio to 50 per centum as the per capita
income of such State bears to the per capita income of
the United States, except that (A) the allotment
percentage shall in no case be more than 75 per centum
or less than 33\1/3\ per centum, and (B) the allotment
percentage for the Commonwealth of Puerto Rico, Guam,
American Samoa, the Trust Territory of the Pacific
Islands, and the Virgin Islands shall be 75 per centum.
(2) The allotment percentages shall be determined
by the Surgeon General between July 1 and September 30
of each even-numbered year, on the basis of the average
of the per capita incomes of each of the States and of
the United States for the three most recent consecutive
years for which satisfactory data are available from
the Department of Commerce, and the States shall be
notified promptly thereof. Such determination shall be
conclusive for each of the two fiscal years in the
period beginning July 1 next succeeding such
determination.
(3) The population of the several States shall be
determined on the basis of the latest figures certified
by the Department of Commerce.
(4) The term ``United States'' means (but only for
purposes of paragraphs (1) and (2)) the fifty States
and the District of Columbia.
(d)(1) Any sum allotted to a State, other than the Virgin
Islands, American Samoa, the Trust Territory of the Pacific
Islands, and Guam for a fiscal year under this section and
remaining unobligated at the end of such year shall remain
available to such State, for the purpose for which made, for
the next two fiscal years (and for such years only), in
addition to the sums allotted to such State for such purposes
for such next two fiscal years.
(2) Any sum allotted to the Virgin Islands, American Samoa,
the Trust Territory of the Pacific Islands, or Guam for a
fiscal year under this section and remaining unobligated at the
end of such year shall remain available to it, for the purpose
for which made, for the next two fiscal years (and for such
years only), in addition to the sums allotted to it for such
purpose for each of such next two fiscal years.
(e)(1) Upon the request of any State that a specified
portion of any allotment of such State under subsection (a) for
any fiscal year be added to any other allotment or allotments
of such State under such subsection for such year, the
Secretary shall promptly (but after application of subsection
(b)) adjust the allotments of such State in accordance with
such request and shall notify the State agency; except that the
aggregate of the portions so transferred from an allotment for
a fiscal year pursuant to this paragraph may not exceed the
amount specified with respect to such allotment in clause (A),
(B), (C), or (D), as the case may be, of subsection (b)(1)
which is applicable to such State.
(2) In addition to the transfer of portions of allotments
under paragraph (1), upon the request of any State that a
specified portion of any allotment of such State under
subsection (a), other than an allotment for grants for the
construction of public or other nonprofit rehabilitation
facilities, be added to another allotment of such State under
such subsection, other than an allotment for grants for the
construction of public or other nonprofit hospitals and public
health centers, and upon simultaneous certification to the
Secretary by the State agency in such State to the effect
that--
(A) it has afforded a reasonable opportunity to
make applications for the portion so specified and
there have been no approvable applications for such
portions, or
(B) in the case of a request to transfer a portion
of an allotment for grants for the construction of
public or other nonprofit hospitals and public health
centers, use of such portion as requested by such State
agency will better carry out the purposes of this
title,
the Secretary shall promptly (but after application of
subsection (b)) adjust the allotments of such State in
accordance with such request and shall notify the State agency.
(3) In addition to the transfer of portions of allotments
under paragraph (1) or (2), upon the request of any State that
a specified portion of an allotment of such State under
paragraph (2) of subsection (a) be added to an allotment of
such State under paragraph (1) of such subsection for grants
for the construction of public or other nonprofit hospitals and
public health centers, and upon simultaneous certification by
the State agency in such State to the effect that the need for
new public or other nonprofit hospitals and public health
centers is substantially greater than the need for
modernization of facilities referred to in paragraph (a) or (b)
of section 601, the Secretary shall promptly (but after
application of subsection (b) of this section) adjust the
allotments of such State in accordance with such request and
shall notify the State agency.
(4) After adjustment of allotments of any State, as
provided in paragraph (1), (2), or (3) of this subsection, the
allotments as so adjusted shall be deemed to be the State's
allotments under this section.
(f) In accordance with regulations, any State may file with
the Surgeon General a request that a specified portion of an
allotment to it under this part for grants for construction of
any type of facility, or for modernization of facilities, be
added to the corresponding allotment of another State for the
purpose of meeting a portion of the Federal share of the cost
of a project for the construction of a facility of that type in
such other State, or for modernization of a facility in such
other State, as the case may be. If it is found by the Surgeon
General (or, in the case of a rehabilitation facility, by the
Surgeon General and the Secretary) that construction or
modernization of the facility with respect to which the request
is made would meet needs of the State making the request and
that use of the specified portion of such State's allotment, as
requested by it, would assist in carrying out the purposes of
this title, such portion of such State's allotment shall be
added to the corresponding allotment of the other State, to be
used for the purpose referred to above.
general regulations
Sec. 603. [291c] The Surgeon General, with the approval of
the Federal Hospital Council and the Secretary of Health,
Education, and Welfare, shall by general regulations
prescribe--
(a) the general manner in which the State agency shall
determine the priority of projects based on the relative need
of different areas lacking adequate facilities of various types
for which assistance is available under this part, giving
special consideration--
(1) in the case of projects for the construction of
hospitals, to facilities serving areas with relatively
small financial resources and, at the option of the
State, rural communities;
(2) in the case of projects for the construction of
rehabilitation facilities, to facilities operated in
connection with a university teaching hospital which
will provide an integrated program of medical,
psychological, social, and vocational evaluation and
services under competent supervision;
(3) in the case of projects for modernization of
facilities, to facilities serving densely populated
areas;
(4) in the case of projects for construction or
modernization of outpatient facilities, to any
outpatient facility that will be located in, and
provide services for residents of, an area determined
by the Secretary to be a rural or urban poverty area;
(5) to projects for facilities which, alone or in
conjunction with other facilities, will provide
comprehensive health care, including outpatient and
preventive care as well as hospitalization;
(6) to facilities which will provide training in
health or allied health professions; and
(7) to facilities which will provide to a
significant extent, for the treatment of alcoholism;
(b) general standards of construction and equipment for
facilities of different classes and in different types of
location, for which assistance is available under this part;
(c) criteria for determining needs for general hospital and
long-term care beds, and needs for hospitals and other
facilities for which aid under this part is available, and for
developing plans for the distribution of such beds and
facilities;
(d) criteria for determining the extent to which existing
facilities, for which aid under this part is available, are in
need of modernization; and
(e) that the State plan shall provide for adequate
hospitals, and other facilities for which aid under this part
is available, for all persons residing in the State, and
adequate hospitals (and such other facilities) to furnish
needed services for persons unable to pay therefor. Such
regulations may also require that before approval of an
application for a project is recommended by a State agency to
the Surgeon General for approval under this part, assurance
shall be received by the State from the applicant that (1) the
facility or portion thereof to be constructed or modernized
will be made available to all persons residing in the
territorial area of the applicant; and (2) there will be made
available in the facility or portion thereof to be constructed
or modernized a reasonable volume of services to persons unable
to pay therefor, but an exception shall be made if such a
requirement is not feasible from a financial viewpoint.
state plans
Sec. 604. [291d] (a) Any State desiring to participate in
this part may submit a State plan. Such plan must--
(1) designate a single State agency as the sole
agency for the administration of the plan, or designate
such agency as the sole agency for supervising the
administration of the plan;
(2) contain satisfactory evidence that the State
agency designated in accordance with paragraph (1) will
have authority to carry out such plan in conformity
with this part;
(3) provide for the designation of a State advisory
council which shall include (A) representatives of
nongovernmental organizations or groups, and of public
agencies, concerned with the operation, construction,
or utilization of hospital or other facilities for
diagnosis, prevention, or treatment of illness or
disease, or for provision of rehabilitation services,
and representatives particularly concerned with
education or training of health professions personnel,
and (B) an equal number of representatives of consumers
familiar with the need for the services provided by
such facilities, to consult with the State agency in
carrying out the plan, and provide, if such council
does not include any representatives of nongovernmental
organizations or groups, or State agencies, concerned
with rehabilitation, for consultation with
organizations, groups, and State agencies so concerned;
(4) set forth, in accordance with criteria
established in regulations prescribed under section 603
and on the basis of a statewide inventory of existing
facilities, a survey of need, and (except to the extent
provided by or pursuant to such regulations) community,
area, or regional plans--
(A) the number of general hospital beds and
long-term care beds, and the number and types
of hospital facilities and facilities for long-
term care, needed to provide adequate
facilities for inpatient care of people
residing in the State, and a plan for the
distribution of such beds and facilities in
service areas throughout the State;
(B) the public health centers needed to
provide adequate public health services for
people residing in the State, and a plan for
the distribution of such centers throughout the
State;
(C) the outpatient facilities needed to
provide adequate diagnostic or treatment
services to ambulatory patients residing in the
State, and a plan for distribution of such
facilities throughout the State;
(D) the rehabilitation facilities needed to
assure adequate rehabilitation services for
disabled persons residing in the State, and a
plan for distribution of such facilities
throughout the State; and
(E) effective January 1, 1966, the extent
to which existing facilities referred to in
section 601 (a) or (b) in the State are in need
of modernization;
(5) set forth a construction and modernization
program conforming to the provisions set forth pursuant
to paragraph (4) and regulations prescribed under
section 603 and providing for construction or
modernization of the hospital or long-term care
facilities, public health centers, outpatient
facilities and rehabilitation facilities which are
needed, as determined under the provisions so set forth
pursuant to paragraph (4);
(6) set forth, with respect to each of such types
of medical facilities, the relative need, determined in
accordance with regulations prescribed under section
603, for projects for facilities of that type, and
provide for the construction or modernization, insofar
as financial resources available therefor and for
maintenance and operation make possible, in the order
of such relative need;
(7) provide minimum standards (to be fixed in the
discretion of the State) for the maintenance and
operation of facilities providing inpatient care which
receive aid under this part and, effective July 1,
1966, provide for enforcement of such standards with
respect to projects approved by the Surgeon General
under this part after June 30, 1964;
(8) provide such methods of administration of the
State plan, including methods relating to the
establishment and maintenance of personnel standards on
a merit basis (except that the Surgeon General shall
exercise no authority with respect to the selection,
tenure of office, or compensation of any individual
employed in accordance with such methods), as are found
by the Surgeon General to be necessary for the proper
and efficient operation of the plan;
(9) provide for affording to every applicant for a
construction or modernization project an opportunity
for a hearing before the State agency;
(10) provide that the State agency will make such
reports, in such form and containing such information,
as the Surgeon General may from time to time reasonably
require, and will keep such records and afford such
access thereto as the Surgeon General may find
necessary to assure the correctness and verification of
such reports;
(11) provide that the Comptroller General of the
United States or his duly authorized representatives
shall have access for the purpose of audit and
examination to the records specified in paragraph (10);
(12) provide that the State agency will from time
to time, but not less often than annually, review its
State plan and submit to the Surgeon General any
modifications thereof which it considers necessary; and
(13) effective July 1, 1971, provide that before
any project for construction or modernization of any
general hospital is approved by the State agency there
will be reasonable assurance of adequate provision for
extended care services (as determined in accordance
with regulations) to patients of such hospital when
such services are medically appropriate for them, with
such services being provided in facilities which (A)
are structurally part of, physically connected with, or
in immediate proximity to, such hospital, and (B)
either (i) are under the supervision of the
professional staff of such hospital or (ii) have
organized medical staffs and have in effect transfer
agreements with such hospital; except that the
Secretary may, at the request of the State agency,
waive compliance with clause (A) or (B), or both such
clauses, as the case may be, in the case of any project
if the State agency has determined that compliance with
such clause or clauses in such case would be
inadvisable.
(b) The Surgeon General shall approve any State plan and
any modification thereof which complies with the provisions of
subsection (a). If any such plan or modification thereof shall
have been disapproved by the Surgeon General for failure to
comply with subsection (a), the Federal Hospital Council shall,
upon request of the State agency, afford it an opportunity for
hearing. If such Council determines that the plan or
modification complies with the provisions of such subsection,
the Surgeon General shall thereupon approve such plan or
modification.
approval of projects for construction or modernization
Sec. 605. [291e] (a) For each project pursuant to a State
plan approved under this part, there shall be submitted to the
Surgeon General, through the State agency, an application by
the State or a political subdivision thereof or by a public or
other nonprofit agency. If two or more such agencies join in
the project, the application may be filed by one or more of
such agencies. Such application shall set forth--
(1) a description of the site for such project;
(2) plans and specifications therefor, in
accordance with regulations prescribed under section
603;
(3) reasonable assurance that title to such site is
or will be vested on one or more of the agencies filing
the application or in a public or other nonprofit
agency which is to operate the facility on completion
of the project;
(4) reasonable assurance that adequate financial
support will be available for the completion of the
project and for its maintenance and operation when
completed;
(5) reasonable assurance that all laborers and
mechanics employed by contractors or subcontractors in
the performance of construction or modernization on the
project will be paid wages at rates not less than those
prevailing on similar work in the locality as
determined by the Secretary of Labor in accordance with
the Davis-Bacon Act, as amended (40 U.S.C. 276a--276a-
5); and the Secretary of Labor shall have with respect
to the labor standards specified in this paragraph the
authority and functions set forth in Reorganization
Plan Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C. 133z-
15) and section 2 of the Act of June 13, 1934, as
amended (40 U.S.C. 276c); and
(6) a certification by the State agency of the
Federal share for the project.
(b) The Surgeon General shall approve such application if
sufficient funds to pay the Federal share of the cost of such
project are available from the appropriate allotment to the
State, and if the Surgeon General finds (1) that the
application contains such reasonable assurance as to title,
financial support, and payment of prevailing rates of wages;
(2) that the plans and specifications are in accord with the
regulations prescribed pursuant to section 603; (3) that the
application is in conformity with the State plan approved under
section 604 and contains an assurance that in the operation of
the project there will be compliance with the applicable
requirements of the regulations prescribed under section
603(e), and with State standards for operation and maintenance;
and (4) that the application has been approved and recommended
by the State agency, opportunity has been provided, prior to
such approval and recommendation, for consideration of the
project by the public or nonprofit private agency or
organization which has developed the comprehensive regional,
metropolitan area, or other local area plan or plans referred
to in section 314(b) covering the area in which such project is
to be located or, if there is no such agency or organization,
by the State agency administering or supervising the
administration of the State plan approved under section 314(a),
and the application is for a project which is entitled to
priority over other projects within the State in accordance
with the regulations prescribed pursuant to section 603(a).
Notwithstanding the preceding sentence, the Surgeon General may
approve such an application for a project for construction or
modernization of a rehabilitation facility only if it is also
approved by the Secretary of Health, Education, and Welfare.
(c) No application shall be disapproved until the Surgeon
General has afforded the State agency an opportunity for a
hearing.
(d) Amendment of any approved application shall be subject
to approval in the same manner as an original application.
(e) Notwithstanding any other provision of this title, no
application for an outpatient facility shall be approved under
this section unless the applicant is (1) a State, political
subdivision, or public agency, or (2) a corporation or
association which owns and operates a nonprofit hospital (as
defined in section 645) or which provides reasonable assurance
that the services of a general hospital will be available to
patients of such facility who are in need of hospital
care.* deg.
payments for construction or modernization
Sec. 606. [291f] (a) Upon certification to the Surgeon
General by the State agency, based upon inspection by it, that
work has been performed upon a project, or purchases have been
made, in accordance with the approved plans and specifications,
and that payment of an installment is due to the applicant,
such installment shall be paid to the State, from the
applicable allotment of such State, except that (1) if the
State is not authorized by law to make payments to the
applicant, or if the State so requests, the payment shall be
made directly to the applicant, (2) if the Surgeon General,
after investigation or otherwise, has reason to believe that
any act (or failure to act) has occurred requiring action
pursuant to section 607, payment may, after he has given the
State agency notice of opportunity for hearing pursuant to such
section, be withheld, in whole or in part, pending corrective
action or action based on such hearing, and (3) the total of
payments under this subsection with respect to such project may
not exceed an amount equal to the Federal share of the cost of
construction of such project.* deg.
(b) In case an amendment to an approved application is
approved as provided in section 605 or the estimated cost of a
project is revised upward, any additional payment with respect
thereto may be made from the applicable allotment of the State
for the fiscal year in which such amendment or revision is
approved.
(c)(1) At the request of any State, a portion of any
allotment or allotments of such State under this part shall be
available to pay one-half (or such smaller share as the State
may request) of the expenditures found necessary by the Surgeon
General for the proper and efficient administration during such
year of the State plan approved under this part; except that
not more than 4 per centum of the total of the allotments of
such State for a year, or $100,000, whichever is less, shall be
available for such purpose for such year. Payments of amounts
due under this paragraph may be made in advance or by way of
reimbursement, and in such installments, as the Surgeon General
may determine.
(2) Any amount paid under paragraph (1) to any State for
any fiscal year shall be paid on condition that there shall be
expended from State sources for such year for administration of
the State plan approved under this part not less than the total
amount expended for such purposes from such sources during the
fiscal year ending June 30, 1970.
withholding of payments
Sec. 607. [291g] Whenever the Surgeon General, after
reasonable notice and opportunity for hearing to the State
agency designated as provided in section 604(a)(1), finds--
(a) that the State agency is not complying
substantially with the provisions required by section
604 to be included in its State plan; or
(b) that any assurance required to be given in an
application filed under section 605 is not being or
cannot be carried out; or
(c) that there is a substantial failure to carry
out plans and specifications approved by the Surgeon
General under section 605; or
(d) that adequate State funds are not being
provided annually for the direct administration of the
State plan,
the Surgeon General may forthwith notify the State agency
that--
(e) no further payments will be made to the State
under this part, or
(f) no further payments will be made from the
allotments of such State from appropriations under any
one or more subparagraphs or paragraphs of section 601,
or for any project or projects, designated by the
Surgeon General as being affected by the action or
inaction referred to in paragraph (a), (b), (c), or (d)
of this section, as the Surgeon General may determine
to be appropriate under the circumstances; and, except
with regard to any project for which the application
has already been approved and which is not directly
affected, further payments may be withheld, in whole or
in part, until there is no longer any failure to comply
(or carry out the assurance or plans and specifications
or provide adequate State funds, as the case may be)
or, if such compliance (or other action) is impossible,
until the State repays or arranges for the repayment of
Federal moneys to which the recipient was not entitled.
judicial review
Sec. 608. [291h] (a) If the Surgeon General refuses to
approve any application for a project submitted under section
605 or section 610, the State agency through which such
application was submitted, or if any State is dissatisfied with
his action under section 607 such State may appeal to the
United States court of appeals for the circuit in which such
State is located, by filing a petition with such court within
sixty days after such action. A copy of the petition shall be
forthwith transmitted by the clerk of the court to the Surgeon
General, or any officer designated by him for that purpose. The
Surgeon General shall thereupon file in the court the record of
the proceedings on which he based his action, as provided in
section 2112 of title 28, United States Code. Upon the filing
of such petition, the court shall have jurisdiction to affirm
the action of the Surgeon General or to set it aside, in whole
or in part, temporarily or permanently, but until the filing of
the record, the Surgeon General may modify or set aside his
order.
(b) The findings of the Surgeon General as to the facts, if
supported by substantial evidence, shall be conclusive, but the
court, for good cause shown, may remand the case to the Surgeon
General to take further evidence, and the Surgeon General may
thereupon make new or modified findings of fact and may modify
his previous action, and shall file in the court the record of
the further proceedings. Such new or modified findings of fact
shall likewise be conclusive if supported by substantial
evidence.
(c) The judgment of the court affirming or setting aside,
in whole or in part, any action of the Surgeon General shall be
final, subject to review by the Supreme Court of the United
States upon certiorari or certification as provided in section
1254 of title 28, United States Code. The commencement of
proceedings under this section shall not, unless so
specifically ordered by the court, operate as a stay of the
Surgeon General's action.
recovery
Sec. 609. \1\ [291i] (a) If any facility with respect to
which funds have been paid under section 606 shall, at any time
within 20 years after the completion of construction or
modernization--
---------------------------------------------------------------------------
\1\ Subtitle D of title VII of Public Law 100-607 waived the
applicability of section 609 regarding a specified medical facility if
certain conditions relating to satisfaction of the obligations under
section 603(e) were met. (The text of such subtitle D is provided in
this compilation under the heading ``Waiver Regarding Title VI of
Public Health Service Act''.) Private Law 99-21 provided such a waiver
regarding another specified medical facility.
---------------------------------------------------------------------------
(1) be sold or transferred to any entity (A) which
is not qualified to file an application under section
605, or (B) which is not approved as a transferee by
the State agency designated pursuant to section 604, or
its successor, or
(2) cease to be a public health center or a public
or other nonprofit hospital, outpatient facility,
facility for long-term care, or rehabilitation
facility,
the United States shall be entitled to recover, whether from
the transferor or the transferee (or, in the case of a facility
which has ceased to be public or nonprofit, from the owners
thereof) an amount determined under subsection (c).
(b) The transferor of a facility which is sold or
transferred as described in subsection (a)(1), or the owner of
a facility the use of which is changed as described in
subsection (a)(2), shall provide the Secretary written notice
of such sale, transfer, or change not later than the expiration
of 10 days from the date on which such sale, transfer, or
change occurs.
(c)(1) except as provided in paragraph (2), the amount the
United States shall be entitled to recover under subsection (a)
is an amount bearing the same ratio to the then value (as
determined by the agreement of the parties or in an action
brought in the district court of the United States for the
district for which the facility involved is situated) of so
much of the facility as constituted an approved project or
projects as the amount of the Federal participation bore to the
cost of the construction or modernization of such project or
projects.
(2)(A) After the expiration of--
(i) 180 days after the date of the sale, transfer,
or change of use for which a notice is required by
subsection (b), in the case of a facility which is sold
or transferred or the use of which changes after the
date of the enactment of this subsection, or
(ii) thirty days after the date of the enactment of
this subsection or if later 180 days after the date of
the sale, transfer, or change of use for which a notice
is required by subsection (b), in the case of a
facility which was sold or transferred or the use of
which changed before the date of the enactment of this
subsection. \1\
---------------------------------------------------------------------------
\1\ So in law. The period probably should be a comma.
---------------------------------------------------------------------------
the amount which the United States is entitled to recover under
paragraph (1) with respect to a facility shall be the amount
prescribed by paragraph (1) plus interest, during the period
described in subparagraph (B), at a rate (determined by the
Secretary) based on the average of the bond equivalent of the
weekly ninety-day Treasury bill auction rate.
(B) The period referred to in subparagraph (A) is the
period beginning--
(i) in the case of a facility which was sold or
transferred or the use of which changed before the date
of the enactment of this subsection, thirty days after
such date or if later 180 days after the date of the
sale, transfer, or change of use for which a notice is
required by subsection (b),
(ii) in the case of a facility with respect to
which notice is provided in accordance with subsection
(b), upon the expiration of 180 days after the receipt
of such notice, or
(iii) in the case of a facility with respect to
which such notice is not provided as prescribed by
subsection (b), on the date of the sale, transfer, or
change of use for which such notice was to be provided,
and ending on the date the amount the United States is entitled
to under paragraph (1) is collected.
(d)(1) The Secretary may waive the recovery rights of the
United States under subsection (a)(1) with respect to a
facility in any State if the Secretary determines, in
accordance with regulations, that the entity to which the
facility was sold or transferred--
(A) has established an irrevocable trust--
(i) in an amount equal to the greater of
twice the cost of the remaining obligation of
the facility under clause (2) of section 603(e)
or the amount, determined under subsection (c),
that the United States is entitled to recover,
and
(ii) which will only be used by the entity
to provide the care required by clause (2) of
section 603(e); and
(B) will meet the obligation of the facility under
clause (1) of section 603(e).
(2) The Secretary may waive the recovery rights of the
United States under subsection (a)(2) with respect to a
facility in any State if the Secretary determines, in
accordance with regulations, that there is good cause for
waiving such rights with respect to such facility.
(e) The right of recovery of the United States under
subsection (a) shall not constitute a lien on any facility with
respect to which funds have been paid under section 606.
loans for construction or modernization of hospitals and other medical
facilities
Sec. 610. [291j] (a) In order further to assist the States
in carrying out the purposes of this title, the Surgeon General
is authorized to make a loan of funds to the applicant for any
project for construction or modernization which meets all of
the conditions specified for a grant under this part.
(b) Except as provided in this section, an application for
a loan with respect to any project under this part shall be
submitted, and shall be approved by the Surgeon General, in
accordance with the same procedures and subject to the same
limitations and conditions as would be applicable to the making
of a grant under this part for such project. Any such
application may be approved in any fiscal year only if
sufficient funds are available from the allotment for the type
of project involved. All loans under this section shall be paid
directly to the applicant.
(c)(1) The amount of a loan under this part shall not
exceed an amount equal to the Federal share of the estimated
cost of construction or modernization under the project. Where
a loan and a grant are made under this part with respect to the
same project, the aggregate amount of such loan and such grant
shall not exceed an amount equal to the Federal share of the
estimated cost of construction or modernization under the
project. Each loan shall bear interest at the rate arrived at
by adding one-quarter of 1 per centum per annum to the rate
which the Secretary of the Treasury determines to be equal to
the current average yield on all outstanding marketable
obligations of the United States as of the last day of the
month preceding the date the application for the loan is
approved and by adjusting the result so obtained to the nearest
one-eighth of 1 per centum. Each loan made under this part
shall mature not more than forty years after the date on which
such loan is made, except that nothing in this part shall
prohibit the payment of all or part of the loan at any time
prior to the maturity date. In addition to the terms and
conditions provided for, each loan under this part shall be
made subject to such terms, conditions, and covenants relating
to repayment of principal, payment of interest, and other
matters as may be agreed upon by the applicant and the Surgeon
General.
(2) The Surgeon General may enter into agreements modifying
any of the terms and conditions of a loan made under this part
whenever he determines such action is necessary to protect the
financial interest of the United States.
(3) If, at any time before a loan for a project has been
repaid in full, any of the events specified in clause (a) or
clause (b) of section 609 occurs with respect to such project,
the unpaid balance of the loan shall become immediately due and
payable by the applicant, and any transferee of the facility
shall be liable to the United States for such repayment.
(d) Any loan under this part shall be made out of the
allotment from which a grant for the project concerned would be
made. Payments of interest and repayments of principal on loans
under this part shall be deposited in the Treasury as
miscellaneous receipts.
Part B--Loan Guarantees and Loans for Modernization and Construction of
Hospitals and Other Medical Facilities
authorization of loan guarantees and loans
Sec. 621. [291j-1] (a)(1) In order to assist nonprofit
private agencies to carry out needed projects for the
modernization or construction of nonprofit private hospitals,
facilities for long-term care, outpatient facilities, and
rehabilitation facilities, the Secretary, during the period
July 1, 1970, through June 30, 1974, may, in accordance with
the provisions of this part, guarantee to non-Federal lenders
making loans to such agencies for such projects, payment of
principal of and interest on loans, made by such lenders, which
are approved under this part.
(2) In order to assist public agencies to carry out needed
projects for the modernization or construction of public health
centers, and public hospitals, facilities for long-term care,
outpatient facilities, and rehabilitation facilities, the
Secretary, during the period July 1, 1970, through June 30,
1974, may, in accordance with the provisions of this part, make
loans to such agencies which shall be sold and guaranteed in
accordance with section 627.
(b)(1) No loan guarantee under this part with respect to
any modernization or construction project may apply to so much
of the principal amount thereof as, when added to the amount of
any grant or loan under part A with respect to such project,
exceeds 90 per centum of the cost of such project.
(2) No loan to a public agency under this part shall be
made in an amount which, when added to the amount of any grant
or loan under part A with respect to such project, exceeds 90
per centum of the cost of such project.
(c) The Secretary, with the consent of the Secretary of
Housing and Urban Development, shall obtain from the Department
of Housing and Urban Development such assistance with respect
to the administration of this part as will promote efficiency
and economy thereof.
allocation among the states
Sec. 622. [291j-2] (a) For each fiscal year, the total
amount of principal of loans to nonprofit private agencies
which may be guaranteed or loans to public agencies which may
be directly made under this part shall be allotted by the
Secretary among the States, in accordance with regulations, on
the basis of each State's relative population, financial need,
need for construction of the facilities referred to in section
621(a), and need for modernization of such facilities.
(b) Any amount allotted under subsection (a) to a State for
a fiscal year ending before July 1, 1973, and remaining
unobligated at the end of such year shall remain available to
such State, for the purpose for which made, for the next two
fiscal years (and for such years only), and any such amount
shall be in addition to the amounts allotted to such State for
such purpose for each of such next two fiscal years; except
that, with the consent of any such State, any such amount
remaining unobligated at the end of the first of such next
fiscal year may be reallotted (on such basis as the Secretary
deems equitable and consistent with the purposes of this title)
to other States which have need therefor. Any amounts so
reallotted to a State shall be available for the purposes for
which made until the close of the second such next two fiscal
years and shall be in addition to the amount allotted and
available to such State for the same period.
(c) Any amount allotted or reallotted to a State under this
section for a fiscal year shall not, until the expiration of
the period during which it is available for obligation, be
considered as available for allotment for a subsequent fiscal
year.
(d) The allotments of any State under subsection (a) for
the fiscal year ending June 30, 1971, and the succeeding fiscal
year shall also be available to guarantee loans with respect to
any project, for modernization or construction of a nonprofit
private hospital or other health facility referred to in
section 621(a)(1), if the modernization or construction of such
facility was not commenced earlier than January 1, 1968, and if
the State certifies and the Secretary finds that without such
guaranteed loan such facility could not be completed and begin
to operate or could not continue to operate, but with such
guaranteed loan would be able to do so: Provided, That this
subsection shall not apply to more than two projects in any one
State.
applications and conditions
Sec. 623. [291j-3] (a) For each project for which a
guarantee of a loan to a nonprofit private agency or a direct
loan to a public agency is sought under this part, there shall
be submitted to the Secretary, through the State agency
designated in accordance with section 604, an application by
such private nonprofit agency or by such public agency. If two
or more private nonprofit agencies, or two or more public
agencies, join in the project, the application may be filed by
one or more such agencies. Such application shall (1) set forth
all of the descriptions, plans, specifications, assurances, and
information which are required by the third sentence of section
605(a) (other than clause (6) thereof) with respect to
applications submitted under that section, (2) contain such
other information as the Secretary may require to carry out the
purposes of this part, and (3) include a certification by the
State agency of the total cost of the project and the amount of
the loan for which a guarantee is sought under this part, or
the amount of the direct loan sought under this part, as the
case may be.
(b) The Secretary may approve such application only if--
(1) there remains sufficient balance in the
allotment determined for such State pursuant to section
622 to cover the amount of the loan for which a
guarantee is sought, or the amount of the direct loan
sought (as the case may be), in such application,
(2) he makes each of the findings which are
required by clauses (1) through (4) of section 605(b)
for the approval of applications for projects
thereunder (except that, in the case of the finding
required under such clause (4) of entitlement of a
project to a priority established under section 603(a),
such finding shall be made without regard to the
provisions of clauses (1) and (3) of such section),
(3) he finds that there is compliance with section
605(e),
(4) he obtains assurances that the applicant will
keep such records, and afford such access thereto, and
make such reports, in such form and containing such
information, as the Secretary may reasonably require,
and
(5) he also determines, in the case of a loan for
which a guarantee is sought, that the terms,
conditions, maturity, security (if any), and schedule
and amounts of repayments with respect to the loan are
sufficient to protect the financial interests of the
United States and are otherwise reasonable and in
accord with regulations, including a determination that
the rate of interest does not exceed such per centum
per annum on the principal obligation outstanding as
the Secretary determines to be reasonable, taking into
account the range of interest rates prevailing in the
private market for similar loans and the risks assumed
by the United States.
(c) No application under this section shall be disapproved
until the Secretary has afforded the State agency an
opportunity for a hearing.
(d) Amendment of an approved application shall be subject
to approval in the same manner as an original application.
(e)(1) In the case of any loan to a nonprofit private
agency, the United States shall be entitled to recover from the
applicant the amount of any payments made pursuant to any
guarantee of such loan under this part, unless the Secretary
for good cause waives its right of recovery, and, upon making
any such payment, the United States shall be subrogated to all
of the rights of the recipient of the payments with respect to
which the guarantee was made.
(2) Guarantees of loans to nonprofit private agencies under
this part shall be subject to such further terms and conditions
as the Secretary determines to be necessary to assure that the
purposes of this part will be achieved, and, to the extent
permitted by subsection (f), any of such terms and conditions
may be modified by the Secretary to the extent he determines it
to be consistent with the financial interest of the United
States.
(f) Any guarantee of a loan to a nonprofit private agency
made by the Secretary pursuant to this part shall be
incontestable in the hands of an applicant on whose behalf such
guarantee is made, and as to any person who makes or contracts
to make a loan to such applicant in reliance thereon, except
for fraud or misrepresentation on the part of such applicant or
such other person.
payment of interest on guaranteed loan
Sec. 624. [291j-4] (a) Subject to the provisions of
subsection (b), in the case of a guarantee of any loan to a
nonprofit private agency under this part with respect to a
hospital or other medical facility, the Secretary shall pay, to
the holder of such loan and for and on behalf of such hospital
or other medical facility amounts sufficient to reduce by 3 per
centum per annum the net effective interest rate otherwise
payable on such loan. Each holder of a loan, to a nonprofit
private agency, which is guaranteed under this part shall have
a contractual right to receive from the United States interest
payments required by the preceding sentence.
(b) Contracts to make the payments provided for in this
section shall not carry an aggregate amount greater than such
amount as may be provided in appropriations Acts.
limitation on amount of loans guaranteed or directly made
Sec. 625. [291j-5] The cumulative total of the principal of
the loans outstanding at any time with respect to which
guarantees have been issued, or which have been directly made,
under this part may not exceed the lesser of--
(1) such limitations as may be specified in
appropriations Acts, or
(2) in the case of loans covered by allotments for
the fiscal year ending June 30, 1971, $500,000,000; for
the fiscal year ending June 30, 1972, $1,000,000,000;
and for each of the fiscal years ending June 30, 1973,
and June 30, 1974.
loan guarantee and loan fund
Sec. 626. [291j-6] (a)(1) There is hereby established in
the Treasury a loan guarantee and loan fund (hereinafter in
this section referred to as the ``fund'') which shall be
available to the Secretary without fiscal year limitation, in
such amounts as may be specified from time to time in
appropriations Acts, (i) to enable him to discharge his
responsibilities under guarantees issued by him under this
part, (ii) for payment of interest on the loans to nonprofit
agencies which are guaranteed, (iii) for direct loans to public
agencies which are sold and guaranteed, (iv) for payment of
interest with respect to such loans, and (v) for repurchase by
him of direct loans to public agencies which have been sold and
guaranteed. There are authorized to be appropriated to the fund
from time to time such amounts as may be necessary to provide
capital required for the fund. To the extent authorized from
time to time in appropriation Acts, there shall be deposited in
the fund amounts received by the Secretary as interest payments
or repayments of principal on loans and any other moneys,
property, or assets derived by him from his operations under
this part, including any moneys derived from the sale of
assets.
(2) Of the moneys in the fund, there shall be available to
the Secretary for the purpose of making of direct loans to
public agencies only such sums as shall have been appropriated
for such purpose pursuant to section 627 or sums received by
the Secretary from the sale of such loans (in accordance with
such section) and authorized in appropriations Acts to be used
for such purpose.
(b) If at any time the moneys in the fund are insufficient
to enable the Secretary to discharge his responsibilities under
this part--
(i) \1\ to make payments of interest on loans to
nonprofit private agencies which he has guaranteed
under this part;
---------------------------------------------------------------------------
\1\ Clauses (i) through (v) probably should be redesignated as
paragraphs (1) through (5), respectively. See section 201 of Public Law
91-296 (84 Stat. 347).
---------------------------------------------------------------------------
(ii) \1\ to otherwise comply with guarantees under
this part of loans to nonprofit private agencies;
(iii) \1\ to make payments of interest subsidies
with respect to loans to public agencies which he has
made, sold, and guaranteed under this part;
(iv) \1\ in the event of default by public agencies
to make payments of principal and interest on loans
which the Secretary has made, sold, and guaranteed,
under this part, to make such payments to the purchaser
of such loan;
(v) \1\ to repurchase loans to public agencies
which have been sold and guaranteed under this part,
he is authorized to issue to the Secretary of the Treasury
notes or other obligations in such forms and denominations,
bearing such maturities, and subject to such terms and
conditions, as may be prescribed by the Secretary with the
approval of the Secretary of the Treasury, but only in such
amounts as may be specified from time to time in appropriations
Acts. Such notes or other obligations shall bear interest at a
rate determined by the Secretary of the Treasury, taking into
consideration the current average market yield on outstanding
marketable obligations of the United States of comparable
maturities during the month preceding the issuance of the notes
or other obligations. The Secretary of the Treasury is
authorized and directed to purchase any notes and other
obligations issued hereunder and for that purpose he is
authorized to use as a public debt transaction the proceeds
from the sale of any securities issued under the Second Liberty
Bond Act, as amended, and the purposes for which securities may
be issued under that Act, as amended, are extended to include
any purchase of such notes and obligations. The Secretary of
the Treasury may at any time sell any of the notes or other
obligations acquired by him under this subsection. All
redemptions, purchases, and sales by the Secretary of the
Treasury of such notes or other obligations shall be treated as
public debt transactions of the United States. Sums borrowed
under this subsection shall be deposited in the fund and
redemption of such notes and obligations shall be made by the
Secretary from such fund.
provisions applicable to loans to public facilities
Sec. 627. [291j-7] (a)(1) Any loan made by the Secretary to
a public agency under this part for the modernization or
construction of a public hospital or other health facility
shall require such public agency to pay interest thereon at a
rate comparable to the current rate of interest prevailing with
respect to loans, to nonprofit private agencies, which are
guaranteed under this part, for the modernization or
construction of similar facilities in the same or similar
areas, minus 3 per centum per annum.
(2)(A) No loan to a public agency shall be made under this
part unless--
(i) the Secretary is reasonably satisfied that such
agency will be able to make payments of principal and
interest thereon when due, and
(ii) such agency provides the Secretary with
reasonable assurances that there will be available to
such agency such additional funds as may be necessary
to complete the project with respect to which such loan
is requested.
(B) Any loan to a public agency shall have such security,
have such maturity date, be repayable in such installments, and
be subject to such other terms and conditions (including
provision for recovery in case of default) as the Secretary
determines to be necessary to carry out the purposes of this
part while adequately protecting the financial interests of the
United States.
(3) In making loans to public agencies under this part, the
Secretary shall give due regard to achieving an equitable
geographical distribution of such loans.
(b)(1) The Secretary shall from time to time, but with due
regard to the financial interests of the United States, sell
loans referred to in subsection (a)(1) either on the private
market or to the Federal National Mortgage Association in
accordance with section 302 of the Federal National Mortgage
Association Charter Act.
(2) Any loan so sold shall be sold for an amount which is
equal (or approximately equal) to the amount of the unpaid
principal of such loan as of the time of sale.
(c)(1) The Secretary is authorized to enter into an
agreement with the purchaser of any loan sold under this part
under which the Secretary agrees--
(A) to guarantee to such purchaser (and any
successor in interest to such purchaser) payments of
the principal and interest payable under such loan, and
(B) to pay as an interest subsidy to such purchaser
(and any successor in interest of such purchaser)
amounts which when added to the amount of interest
payable on such loan, are equivalent to a reasonable
rate of interest on such loan as determined by the
Secretary, after taking into account the range of
prevailing interest rates in the private market on
similar loans and the risks assumed by the United
States.
(2) Any such agreement--
(A) may provide that the Secretary shall act as
agent of any such purchaser, for the purpose of
collecting from the public agency to which such loan
was made and paying over to such purchaser, any
payments of principal and interest payable by such
agency under such loan;
(B) may provide for the repurchase by the Secretary
of any such loan on such terms and conditions as may be
specified in the agreement;
(C) shall provide that, in the event of any default
by the public agency to which such loan was made in
payment of principal and interest due on such loan, the
Secretary shall, upon notification to the purchaser (or
to the successor in interest of such purchaser), have
the option to close out such loan (and any obligations
of the Secretary with respect thereto) by paying to the
purchaser (or his successor in interest) the total
amount of outstanding principal and interest due
thereon at the time of such notification; and
(D) shall provide that, in the event such loan is
closed out as provided in subparagraph (C), or in the
event of any other loss incurred by the Secretary by
reason of the failure of such public agency to make
payments of principal and interest on such loan, the
Secretary shall be subrogated to all rights of such
purchaser for recovery of such loss from such public
agency.
(d) The Secretary may, for good cause, waive any right of
recovery which he has against a public agency by reason of the
failure of such agency to make payments of principal and
interest on a loan made to such agency under this part.
(e) After any loan to a public agency under this part has
been sold and guaranteed, interest paid on such loan and any
interest subsidy paid by the Secretary with respect to such
loan which is received by the purchaser thereof (or his
successor in interest) shall be included in gross income for
the purposes of chapter 1 of the Internal Revenue Code of 1954.
(f) Amounts received by the Secretary as proceeds from the
sale of loans under this section shall be deposited in the loan
fund established by section 626, and shall be available to the
Secretary for the making of further loans under this part in
accordance with the provisions of subsection (a)(2) of such
section.
(g) There is authorized to be appropriated to the
Secretary, for deposit in the loan fund established by section
626, $30,000,000 to provide initial capital for the making of
direct loans by the Secretary to public agencies for the
modernization or construction of facilities referred to in
subsection (a)(1).
Part C--Construction or Modernization of Emergency Rooms
authorization
Sec. 631. [291j-8] In order to assist in the provision of
adequate emergency room service in various communities of the
Nation for treatment of accident victims and handling of other
medical emergencies through special project grants for the
construction or modernization of emergency rooms of general
hospitals, there are authorized to be appropriated $20,000,000
each for the fiscal year ending June 30, 1971, and the next two
fiscal years.
eligibility for grants
Sec. 632. [291j-9] Funds appropriated pursuant to section
631 shall be available for grants by the Secretary for not to
exceed 50 per centum of the cost of construction or
modernization of emergency rooms of public or nonprofit general
hospitals, including provision or replacement of medical
transportation facilities. Such grants shall be made by the
Secretary only after consultation with the State agency
designated in accordance with section 604(a)(1) of the Public
Health Service Act. In order to be eligible for a grant under
this part, the project, and the applicant therefor, must meet
such criteria as may be prescribed by regulations. Such
regulations shall be so designed as to provide aid only with
respect to projects for which adequate assistance is not
readily available from other Federal, State, local, or other
sources, and to assist in providing modern, efficient, and
effective emergency room service needed to care for victims of
highway, industrial, agricultural, or other accidents and to
handle other medical emergencies, and to assist in providing
such service in geographical areas which have special need
therefor.
payments
Sec. 633. [291j-10] Grants under this part shall be paid in
advance or by way of reimbursement, in such installments and on
such conditions, as in the judgment of the Secretary will best
carry out the purposes of this part.
Part D--General
federal hospital council and advisory committees
Sec. 641. [291k] (a) In administering this title, the
Surgeon General shall consult with a Federal Hospital Council
consisting of the Surgeon General, who shall serve as Chairman
ex officio, and twelve members appointed by the Secretary of
Health, Education, and Welfare. Six of the twelve appointed
members shall be persons who are outstanding in fields
pertaining to medical facility and health activities, and three
of these six shall be authorities in matters relating to the
operation of hospitals or other medical facilities, one of them
shall be an authority in matters relating to the mentally
retarded, and one of them shall be an authority in matters
relating to mental health, and the other six members shall be
appointed to represent the consumers of services provided by
such facilities and shall be persons familiar with the need for
such services in urban or rural areas.
(b) Each appointed member shall hold office for a term of
four years, except that any member appointed to fill a vacancy
occurring prior to the expiration of the term for which his
predecessor was appointed shall be appointed for the remainder
of such term. An appointed member shall not be eligible to
serve continuously for more than two terms (whether beginning
before or after enactment of this section) but shall be
eligible for reappointment if he has not served immediately
preceding his reappointment.
(c) The Council shall meet as frequently as the Surgeon
General deems necessary, but not less than once each year. Upon
request by three or more members, it shall be the duty of the
Surgeon General to call a meeting of the Council.
(d) The Council is authorized to appoint such special
advisory or technical committees as may be useful in carrying
out its functions.
conference of state agencies
Sec. 642. [291l] Whenever in his opinion the purposes of
this title would be promoted by a conference, the Surgeon
General may invite representatives of as many State agencies,
designated in accordance with section 604, to confer as he
deems necessary or proper. A conference of the representatives
of all such State agencies shall be called annually by the
Surgeon General. Upon the application of five or more of such
State agencies, it shall be the duty of the Surgeon General to
call a conference of representatives of all State agencies
joining in the request.
state control of operations
Sec. 643. [291m] Except as otherwise specifically provided,
nothing in this title shall be construed as conferring on any
Federal office or employee the right to exercise any
supervision or control over the administration, personnel,
maintenance, or operation of any facility with respect to which
any funds have been or may be expended under this title.
loans for certain hospital experimentation projects
Sec. 643A. [291m-1] (a) In order to alleviate hardship on
any recipient of a grant under section 636 of this title (as in
effect immediately before the enactment of the Hospital and
Medical Facilities Amendments of 1964) for a project for the
construction of an experimental or demonstration facility
having as its specific purpose the application of novel means
for the reduction of hospital costs with respect to which there
has been a substantial increase in the cost of such
construction (over the estimated cost of such project on the
basis of which such grant was made) through no fault of such
recipient, the Secretary is authorized to make a loan to such
recipient not exceeding 66\2/3\ per centum of such increased
costs, as determined by the Secretary, if the Secretary
determines that such recipient is unable to obtain such an
amount for such purpose from other public or private sources.
(b) Any such loan shall be made only on the basis of an
application submitted to the Secretary in such form and
containing such information and assurances as he may prescribe.
(c) Each such loan shall bear interest at the rate of 2\1/
2\ per centum per annum on the unpaid balance thereof and shall
be repayable over a period determined by the Secretary to be
appropriate, but not exceeding fifty years.
(d) There are hereby authorized to be appropriated
$3,500,000 to carry out the provisions of this section.
definitions
Sec. 645. \1\ [291o] For the purposes of this title--
---------------------------------------------------------------------------
\1\ Section 644 was repealed by section 3(b) of Public Law 90-174.
---------------------------------------------------------------------------
(a) The term ``State'' includes the Commonwealth of Puerto
Rico, Guam, American Samoa, the Trust Territory of the Pacific
Islands, the Virgin Islands, and the District of Columbia.
(b)(1) The term ``Federal share'' with respect to any
project means the proportion of the cost of such project to be
paid by the Federal Government under this title.
(2) With respect to any project in any State for which a
grant is made from an allotment from an appropriation under
section 601, the Federal share shall be the amount determined
by the State agency designated in accordance with section 604,
but not more than 66\2/3\ per centum or the State's allotment
percentage, whichever is the lower, except that, if the State's
allotment percentage is lower than 50 per centum, such
allotment percentage shall be deemed to be 50 per centum for
purposes of this paragraph.
(3) Prior to the approval of the first project in a State
during any fiscal year the State agency designated in
accordance with section 604 shall give the Secretary written
notification of the maximum Federal share established pursuant
to paragraph (2) for projects in such State to be approved by
the Secretary during such fiscal year and the method for
determining the actual Federal share to be paid with respect to
such projects; and such maximum Federal share and such method
of determination for projects in such State approved during
such fiscal year shall not be changed after such approval.
(4) Notwithstanding the provisions of paragraphs (2) and
(3) of this subsection, the Federal share shall, at the option
of the State agency, be equal to the per centum provided under
such paragraphs plus an incentive per centum (which when
combined with the per centum provided under such paragraphs
shall not exceed 90 per centum) specified by the State agency
in the case of (A) projects that will provide services
primarily for persons in an area determined by the Secretary to
be a rural or urban poverty area, and (B) projects that offer
potential for reducing health care costs through shared
services among health care facilities, through interfacility
cooperation, or through the construction or modernization of
free-standing outpatient facilities.
(c) The term ``hospital'' includes general, tuberculosis,
and other types of hospitals, and related facilities, such as
laboratories, outpatient departments, nurses' home facilities,
extended care facilities, facilities related to programs for
home health services, self-care units, and central service
facilities, operated in connection with hospitals, and also
includes education or training facilities for health
professions personnel operated as an integral part of a
hospital, but does not include any hospital furnishing
primarily domiciliary care.
(d) The term ``public health center'' means a publicly
owned facility for the provision of public health services,
including related publicly owned facilities such as
laboratories, clinics, and administrative offices operated in
connection with such a facility.
(e) The term ``nonprofit'' as applied to any facility means
a facility which is owned and operated by one or more nonprofit
corporations or associations no part of the net earnings of
which inures, or may lawfully inure, to the benefit of any
private shareholder or individual.
(f) The term ``outpatient facility'' means a facility
(located in or apart from a hospital) for the diagnosis or
diagnosis and treatment of ambulatory patients (including
ambulatory inpatients)--
(1) which is operated in connection with a
hospital, or
(2) in which patient care is under the professional
supervision of persons licensed to practice medicine or
surgery in the State, or in the case of dental
diagnosis or treatment, under the professional
supervision of persons licensed to practice dentistry
in the State; or
(3) which offers to patients not requiring
hospitalization the services of licensed physicians in
various medical specialties, and which provides to its
patients a reasonably full-range of diagnostic and
treatment services.
(g) The term ``rehabilitation facility'' means a facility
which is operated for the primary purpose of assisting in the
rehabilitation of disabled persons through an integrated
program of--
(1) medical evaluation and services, and
(2) psychological, social, or vocational evaluation
and services,
under competent professional supervision, and in the case of
which--
(3) the major portion of the required evaluation
and services is furnished within the facility; and
(4) either (A) the facility is operated in
connection with a hospital, or (B) all medical and
related health services are prescribed by, or are under
the general direction of, persons licensed to practice
medicine or surgery in the State.
(h) The term ``facility for long-term care'' means a
facility (including an extended care facility) providing in-
patient care for convalescent or chronic disease patients who
require skilled nursing care and related medical services--
(1) which is a hospital (other than a hospital
primarily for the care and treatment of mentally ill or
tuberculous patients) or is operated in connection with
a hospital, or
(2) in which such nursing care and medical services
are prescribed by, or are performed under the general
direction of, persons licensed to practice medicine or
surgery in the State.
(i) The term ``construction'' includes construction of new
buildings, expansion, remodeling, and alteration of existing
buildings, and initial equipment of any such buildings
(including medical transportation facilities) and, in any case
in which it will help to provide a service not previously
provided in the community, equipment of any buildings;
including architects' fees, but excluding the cost of off-site
improvements and, except with respect to public health centers,
the cost of the acquisition of land.
(j) The term ``cost'' as applied to construction or
modernization means the amount found by the Surgeon General to
be necessary for construction and modernization respectively,
under a project, except that such term, as applied to a project
for modernization of a facility for which a grant or loan is to
be made from an allotment under section 602(a)(2), does not
include any amount found by the Surgeon General to be
attributable to expansion of the bed capacity of such facility.
(k) The term ``modernization'' includes alteration, major
repair (to the extent permitted by regulations), remodeling,
replacement, and renovation of existing buildings (including
initial equipment thereof), and replacement of obsolete, built-
in (as determined in accordance with regulations) equipment of
existing buildings.
(l) The term ``title,'' when used with reference to a site
for a project, means a fee simple, or such other estate or
interest (including a leasehold on which the rental does not
exceed 4 per centum of the value of the land) as the Surgeon
General finds sufficient to assure for a period of not less
than fifty years' undisturbed use and possession for the
purposes of construction and operation of the
project.* deg.
financial statements
Sec. 646. [291o-1] In the case of any facility for which a
grant, loan, or loan guarantee has been made under this title,
the applicant for such grant, loan, or loan guarantee (or, if
appropriate, such other person as the Secretary may prescribe)
shall file at least annually with the State agency for the
State in which the facility is located a statement which shall
be in such form, and contain such information, as the Secretary
may require to accurately show--
(1) the financial operations of the facility, and
(2) the costs to the facility of providing health
services in the facility and the charges made by the
facility for providing such services,
during the period with respect to which the statement is
filed.ATTORNEY: PMG/FD (June 3, 1999) deg.
TITLE VII--HEALTH PROFESSIONS EDUCATION
PART A--STUDENT LOANS
Subpart I--Insured Health Education Assistance Loans to Graduate
Students
SEC. 701. [292] STATEMENT OF PURPOSE.
The purpose of this subpart is to enable the Secretary to
provide a Federal program of student loan insurance for
students in (and certain former students of) eligible
institutions (as defined in section 719).
SEC. 702. [292A] SCOPE AND DURATION OF LOAN INSURANCE PROGRAM.
(a) In General.--The total principal amount of new loans
made and installments paid pursuant to lines of credit (as
defined in section 719) to borrowers covered by Federal loan
insurance under this subpart shall not exceed $350,000,000 for
fiscal year 1993, $375,000,000 for fiscal year 1994, and
$425,000,000 for fiscal year 1995. If the total amount of new
loans made and installments paid pursuant to lines of credit in
any fiscal year is less than the ceiling established for such
year, the difference between the loans made and installments
paid and the ceiling shall be carried over to the next fiscal
year and added to the ceiling applicable to that fiscal year,
and if in any fiscal year no ceiling has been established, any
difference carried over shall constitute the ceiling for making
new loans (including loans to new borrowers) and paying
installments for such fiscal year. Thereafter, Federal loan
insurance pursuant to this subpart may be granted only for
loans made (or for loan installments paid pursuant to lines of
credit) to enable students, who have obtained prior loans
insured under this subpart, to continue or complete their
educational program or to obtain a loan under section
705(a)(1)(B) to pay interest on such prior loans; but no
insurance may be granted for any loan made or installment paid
after September 30, 1998. The total principal amount of Federal
loan insurance available under this subsection shall be granted
by the Secretary without regard to any apportionment for the
purpose of chapter 15 of title 31, United States Code, and
without regard to any similar limitation.
(b) Certain Limitations and Priorities.--
(1) Limitations regarding lenders, states, or
areas.--The Secretary may, if necessary to assure an
equitable distribution of the benefits of this subpart,
assign, within the maximum amounts specified in
subsection (a), Federal loan insurance quotas
applicable to eligible lenders, or to States or areas,
and may from time to time reassign unused portions of
these quotas.
(2) Priority for certain lenders.--In providing
certificates of insurance under section 706 through
comprehensive contracts, the Secretary shall give
priority to eligible lenders that agree--
(A) to make loans to students at interest
rates below the rates prevailing, during the
period involved, for loans covered by Federal
loan insurance pursuant to this subpart; or
(B) to make such loans under terms that are
otherwise favorable to the student relative to
the terms under which eligible lenders are
generally making such loans during such period.
(c) Authority of Student Loan Marketing Association.--
(1) In general.--Subject to paragraph (2), the
Student Loan Marketing Association, established under
part B of title IV of the Higher Education Act of 1965,
is authorized to make advances on the security of,
purchase, service, sell, consolidate, or otherwise deal
in loans which are insured by the Secretary under this
subpart, except that if any loan made under this
subpart is included in a consolidated loan pursuant to
the authority of the Association under part B of title
IV of the Higher Education Act of 1965, the interest
rate on such consolidated loan shall be set at the
weighted average interest rate of all such loans
offered for consolidation and the resultant per centum
shall be rounded downward to the nearest one-eighth of
1 per centum, except that the interest rate shall be no
less than the applicable interest rate of the
guaranteed student loan program established under part
B of title IV of the Higher Education Act of 1965. In
the case of such a consolidated loan, the borrower
shall be responsible for any interest which accrues
prior to the beginning of the repayment period of the
loan, or which accrues during a period in which
principal need not be paid (whether or not such
principal is in fact paid) by reason of any provision
of the Higher Education Act of 1965.
(2) Applicability of certain federal regulations.--
With respect to Federal regulations for lenders, this
subpart may not be construed to preclude the
applicability of such regulations to the Student Loan
Marketing Association or to any other entity in the
business of purchasing student loans, including such
regulations with respect to applications, contracts,
and due diligence.
SEC. 703. [292B] LIMITATIONS ON INDIVIDUAL INSURED LOANS AND ON LOAN
INSURANCE.
(a) In General.--The total of the loans made to a student
in any academic year or its equivalent (as determined by the
Secretary) which may be covered by Federal loan insurance under
this subpart may not exceed $20,000 in the case of a student
enrolled in a school of medicine, osteopathic medicine,
dentistry, veterinary medicine, optometry, or podiatric
medicine, and $12,500 in the case of a student enrolled in a
school of pharmacy, public health, allied health, or
chiropractic, or a graduate program in health administration or
behavioral and mental health practice, including clinical
psychology. The aggregate insured unpaid principal amount for
all such insured loans made to any borrower shall not at any
time exceed $80,000 in the case of a borrower who is or was a
student enrolled in a school of medicine, osteopathic medicine,
dentistry, veterinary medicine, optometry, or podiatric
medicine, and $50,000 in the case of a borrower who is or was a
student enrolled in a school of pharmacy, public health, allied
health, or chiropractic, or a graduate program in health
administration or clinical psychology. The annual insurable
limit per student shall not be exceeded by a line of credit
under which actual payments by the lender to the borrower will
not be made in any year in excess of the annual limit.
(b) Extent of Insurance Liability.--The insurance liability
on any loan insured by the Secretary under this subpart shall
be 100 percent of the unpaid balance of the principal amount of
the loan plus interest. The full faith and credit of the United
States is pledged to the payment of all amounts which may be
required to be paid under the provisions of section 707 or 714.
SEC. 704. [292C] SOURCES OF FUNDS.
Loans made by eligible lenders in accordance with this
subpart shall be insurable by the Secretary whether made from
funds fully owned by the lender or from funds held by the
lender in a trust or similar capacity and available for such
loans.
SEC. 705. [292D] ELIGIBILITY OF BORROWERS AND TERMS OF INSURED LOANS.
(a) In General.--A loan by an eligible lender shall be
insurable by the Secretary under the provisions of this subpart
only if--
(1) made to--
(A) a student who--
(i)(I) has been accepted for
enrollment at an eligible institution,
or (II) in the case of a student
attending an eligible institution, is
in good standing at that institution,
as determined by the institution;
(ii) is or will be a full-time
student at the eligible institution;
(iii) has agreed that all funds
received under such loan shall be used
solely for tuition, other reasonable
educational expenses, including fees,
books, and laboratory expenses, and
reasonable living expenses, incurred by
such students;
(iv) if required under section 3 of
the Military Selective Service Act to
present himself for and submit to
registration under such section, has
presented himself and submitted to
registration under such section; and
(v) in the case of a pharmacy
student, has satisfactorily completed
three years of training; or
(B) an individual who--
(i) has previously had a loan
insured under this subpart when the
individual was a full-time student at
an eligible institution;
(ii) is in a period during which,
pursuant to paragraph (2), the
principal amount of such previous loan
need not be paid;
(iii) has agreed that all funds
received under the proposed loan shall
be used solely for repayment of
interest due on previous loans made
under this subpart; and
(iv) if required under section 3 of
the Military Selective Service Act to
present himself for and submit to
registration under such section, has
presented himself and submitted to
registration under such section;
(2) evidenced by a note or other written agreement
which--
(A) is made without security and without
endorsement, except that if the borrower is a
minor and such note or other written agreement
executed by him would not, under the applicable
law, create a binding obligation, an
endorsement may be required;
(B) provides for repayment of the principal
amount of the loan in installments over a
period of not less than 10 years (unless sooner
repaid) nor more than 25 years beginning not
earlier than 9 months nor later than 12 months
after the date of--
(i) the date on which--
(I) the borrower ceases to
be a participant in an
accredited internship or
residency program of not more
than four years in duration;
(II) the borrower completes
the fourth year of an
accredited internship or
residency program of more than
four years in duration; or
(III) the borrower, if not
a participant in a program
described in subclause (I) or
(II), ceases to carry, at an
eligible institution, the
normal full-time academic
workload as determined by the
institution; or
(ii) the date on which a borrower
who is a graduate of an eligible
institution ceases to be a participant
in a fellowship training program not in
excess of two years or a participant in
a full-time educational activity not in
excess of two years, which--
(I) is directly related to
the health profession for which
the borrower prepared at an
eligible institution, as
determined by the Secretary;
and
(II) may be engaged in by
the borrower during such a two-
year period which begins within
twelve months after the
completion of the borrower's
participation in a program
described in subclause (I) or
(II) of clause (i) or prior to
the completion of the
borrower's participation in
such program,
except as provided in subparagraph (C), except
that the period of the loan may not exceed 33
years from the date of execution of the note or
written agreement evidencing it, and except
that the note or other written instrument may
contain such provisions relating to repayment
in the event of default in the payment of
interest or in the payment of the costs of
insurance premiums, or other default by the
borrower, as may be authorized by regulations
of the Secretary in effect at the time the loan
is made;
(C) provides that periodic installments of
principal and interest need not be paid, but
interest shall accrue, during any period (i)
during which the borrower is pursuing a full-
time course of study at an eligible institution
(or at an institution defined by section 102(a)
of the Higher Education Act of 1965); (ii) not
in excess of four years during which the
borrower is a participant in an accredited
internship or residency program (including any
period in such a program described in subclause
(I) or subclause (II) of subparagraph (B)(i));
(iii) not in excess of three years, during
which the borrower is a member of the Armed
Forces of the United States; (iv) not in excess
of three years during which the borrower is in
service as a volunteer under the Peace Corps
Act; (v) not in excess of three years during
which the borrower is a member of the National
Health Service Corps; (vi) not in excess of
three years during which the borrower is in
service as a full-time volunteer under title I
of the Domestic Volunteer Service Act of 1973;
(vii) not in excess of 3 years, for a borrower
who has completed an accredited internship or
residency training program in osteopathic
general practice, family medicine, general
internal medicine, preventive medicine, or
general pediatrics and who is practicing
primary care; (viii) not in excess of 1 year,
for borrowers who are graduates of schools of
chiropractic; (ix) any period not in excess of
two years which is described in subparagraph
(B)(ii); (x) not in excess of three years,
during which the borrower is providing health
care services to Indians through an Indian
health program (as defined in section
108(a)(2)(A) of the Indian Health Care
Improvement Act (25 U.S.C. 1616a(a)(2)(A)) \1\;
and (xi) in addition to all other deferments
for which the borrower is eligible under
clauses (i) through (x), any period during
which the borrower is a member of the Armed
Forces on active duty during the Persian Gulf
conflict, and any period described in clauses
(i) through (xi) shall not be included in
determining the 25-year period described in
subparagraph (B);
---------------------------------------------------------------------------
\1\ So in law. Probably should include another closing parenthesis.
---------------------------------------------------------------------------
(D) provides for interest on the unpaid
principal balance of the loan at a yearly rate,
not exceeding the applicable maximum rate
prescribed and defined by the Secretary (within
the limits set forth in subsection (b)) on a
national, regional, or other appropriate basis,
which interest shall be compounded not more
frequently than annually and payable in
installments over the period of the loan except
as provided in subparagraph (C), except that
the note or other written agreement may provide
that payment of any interest may be deferred
until not later than the date upon which
repayment of the first installment of principal
falls due or the date repayment of principal is
required to resume (whichever is applicable)
and may further provide that, on such date, the
amount of the interest which has so accrued may
be added to the principal for the purposes of
calculating a repayment schedule;
(E) offers, in accordance with criteria
prescribed by regulation by the Secretary, a
schedule for repayment of principal and
interest under which payment of a portion of
the principal and interest otherwise payable at
the beginning of the repayment period (as
defined in such regulations) is deferred until
a later time in the period;
(F) entitles the borrower to accelerate
without penalty repayment of the whole or any
part of the loan;
(G) provides that the check for the
proceeds of the loan shall be made payable
jointly to the borrower and the eligible
institution in which the borrower is enrolled;
and
(H) contains such other terms and
conditions consistent with the provisions of
this subpart and with the regulations issued by
the Secretary pursuant to this subpart, as may
be agreed upon by the parties to such loan,
including, if agreed upon, a provision
requiring the borrower to pay to the lender, in
addition to principal and interest, amounts
equal to the insurance premiums payable by the
lender to the Secretary with respect to such
loan; and
(3) subject to the consent of the student and
subject to applicable law, the eligible lender has
obtained from the student appropriate demographic
information regarding the student, including racial or
ethnic background.
(b) Limitation on Rate of Interest.--The rate of interest
prescribed and defined by the Secretary for the purpose of
subsection (a)(2)(D) may not exceed the average of the bond
equivalent rates of the 91-day Treasury bills auctioned for the
previous quarter plus 3 percentage points, rounded to the next
higher one-eighth of 1 percent.
(c) Minimum Annual Payment by Borrower.--The total of the
payments by a borrower during any year or any repayment period
with respect to the aggregate amount of all loans to that
borrower which are insured under this subpart shall not be less
than the annual interest on the outstanding principal, except
as provided in subsection (a)(2)(C), unless the borrower, in
the written agreement described in subsection (a)(2), agrees to
make payments during any year or any repayment period in a
lesser amount.
(d) Applicability of Certain Laws on Rate or Amount of
Interest.--No provision of any law of the United States (other
than subsections (a)(2)(D) and (b)) or of any State that limits
the rate or amount of interest payable on loans shall apply to
a loan insured under this subpart.
(e) Determination Regarding Forbearance.--Any period of
time granted to a borrower under this subpart in the form of
forbearance on the loan shall not be included in the 25-year
total loan repayment period under subsection (a)(2)(C).
(f) Loan Repayment Schedule.--Lenders and holders under
this subpart shall offer borrowers graduated loan repayment
schedules that, during the first 5 years of loan repayment, are
based on the borrower's debt-to-income ratio.
(g) Rule of Construction Regarding Determination of Need of
Students.--With respect to any determination of the financial
need of a student for a loan covered by Federal loan insurance
under this subpart, this subpart may not be construed to limit
the authority of any school to make such allowances for
students with special circumstances as the school determines
appropriate.
(h) Definitions.--For purposes of this section:
(1) The term ``active duty'' has the meaning given
such term in section 101(18) of title 37, United States
Code, except that such term does not include active
duty for training.
(2) The term ``Persian Gulf conflict'' means the
period beginning on August 2, 1990, and ending on the
date thereafter prescribed by Presidential proclamation
or by law.
SEC. 706. [292E] CERTIFICATE OF LOAN INSURANCE; EFFECTIVE DATE OF
INSURANCE.
(a) In General.--
(1) Authority for issuance of certificate.--If,
upon application by an eligible lender, made upon such
form, containing such information, and supported by
such evidence as the Secretary may require, and
otherwise in conformity with this section, the
Secretary finds that the applicant has made a loan to
an eligible borrower which is insurable under the
provisions of this subpart, he may issue to the
applicant a certificate of insurance covering the loan
and setting forth the amount and terms of the
insurance.
(2) Effective date of insurance.--Insurance
evidenced by a certificate of insurance pursuant to
subsection (a)(1) shall become effective upon the date
of issuance of the certificate, except that the
Secretary is authorized, in accordance with
regulations, to issue commitments with respect to
proposed loans, or with respect to lines (or proposed
lines) of credit, submitted by eligible lenders, and in
that event, upon compliance with subsection (a)(1) by
the lender, the certificate of insurance may be issued
effective as of the date when any loan, or any payment
by the lender pursuant to a line of credit, to be
covered by such insurance is made to a student
described in section 705(a)(1). Such insurance shall
cease to be effective upon 60 days' default by the
lender in the payment of any installment of the
premiums payable pursuant to section 708.
(3) Certain agreements for lenders.--An application
submitted pursuant to subsection (a)(1) shall contain--
(A) an agreement by the applicant to pay,
in accordance with regulations, the premiums
fixed by the Secretary pursuant to section 708;
and
(B) an agreement by the applicant that if
the loan is covered by insurance the applicant
will submit such supplementary reports and
statements during the effective period of the
loan agreement, upon such forms, at such times,
and containing such information as the
Secretary may prescribe by or pursuant to
regulation.
(b) Authority Regarding Comprehensive Insurance Coverage.--
(1) In general.--In lieu of requiring a separate
insurance application and issuing a separate
certificate of insurance for each loan made by an
eligible lender as provided in subsection (a), the
Secretary may, in accordance with regulations
consistent with section 702, issue to any eligible
lender applying therefor a certificate of comprehensive
insurance coverage which shall, without further action
by the Secretary, insure all insurable loans made by
that lender, on or after the date of the certificate
and before a specified cutoff date, within the limits
of an aggregate maximum amount stated in the
certificate. Such regulations may provide for
conditioning such insurance, with respect to any loan,
upon compliance by the lender with such requirements
(to be stated or incorporated by reference in the
certificate) as in the Secretary's judgment will best
achieve the purpose of this subsection while protecting
the financial interest of the United States and
promoting the objectives of this subpart, including
(but not limited to) provisions as to the reporting of
such loans and information relevant thereto to the
Secretary and as to the payment of initial and other
premiums and the effect of default therein, and
including provision for confirmation by the Secretary
from time to time (through endorsement of the
certificate) of the coverage of specific new loans by
such certificate, which confirmation shall be
incontestable by the Secretary in the absence of fraud
or misrepresentation of fact or patent error.
(2) Lines of credit beyond cutoff date.--If the
holder of a certificate of comprehensive insurance
coverage issued under this subsection grants to a
borrower a line of credit extending beyond the cutoff
date specified in that certificate, loans or payments
thereon made by the holder after that date pursuant to
the line of credit shall not be deemed to be included
in the coverage of that certificate except as may be
specifically provided therein; but, subject to the
limitations of section 702, the Secretary may, in
accordance with regulations, make commitments to insure
such future loans or payments, and such commitments may
be honored either as provided in subsection (a) or by
inclusion of such insurance in comprehensive coverage
under this subsection for the period or periods in
which such future loans or payments are made.
(c) Assignment of Insurance Rights.--The rights of an
eligible lender arising under insurance evidenced by a
certificate of insurance issued to it under this section may be
assigned by such lender, subject to regulation by the
Secretary, only to--
(1) another eligible lender (including a public
entity in the business of purchasing student loans); or
(2) the Student Loan Marketing Association.
(d) Effect of Refinancing or Consolidation of
Obligations.--The consolidation of the obligations of two or
more federally insured loans obtained by a borrower in any
fiscal year into a single obligation evidenced by a single
instrument of indebtedness or the refinancing of a single loan
shall not affect the insurance by the United States. If the
loans thus consolidated are covered by separate certificates of
insurance issued under subsection (a), the Secretary may upon
surrender of the original certificates issue a new certificate
of insurance in accordance with that subsection upon the
consolidated obligation. If the loans thus consolidated are
covered by a single comprehensive certificate issued under
subsection (b), the Secretary may amend that certificate
accordingly.
(e) Rule of Construction Regarding Consolidation of Debts
and Refinancing.--Nothing in this section shall be construed to
preclude the lender and the borrower, by mutual agreement, from
consolidating all of the borrower's loans insured under this
subpart into a single instrument (or, if the borrower obtained
only 1 loan insured under this subpart, refinancing the loan 1
time) under the terms applicable to an insured loan made at the
same time as the consolidation. The lender or loan holder
should provide full information to the borrower concerning the
advantages and disadvantages of loan consolidation or
refinancing. Nothing in this section shall be construed to
preclude the consolidation of the borrower's loans insured
under this subpart under section 428C of the Higher Education
Act of 1965. Any loans insured pursuant to this subpart that
are consolidated under section 428C of such Act shall not be
eligible for special allowance payments under section 438 of
such Act.
SEC. 707. [292F] DEFAULT OF BORROWER.
(a) Conditions for Payment to Beneficiary.--
(1) In general.--Upon default by the borrower on
any loan covered by Federal loan insurance pursuant to
this subpart, and after a substantial collection effort
(including, subject to subsection (h), commencement and
prosecution of an action) as determined under
regulations of the Secretary, the insurance beneficiary
shall promptly notify the Secretary and the Secretary
shall, if requested (at that time or after further
collection efforts) by the beneficiary, or may on his
own motion, if the insurance is still in effect, pay to
the beneficiary the amount of the loss sustained by the
insured upon that loan as soon as that amount has been
determined, except that, if the insurance beneficiary
including any servicer of the loan is not designated
for ``exceptional performance'', as set forth in
paragraph (2), the Secretary shall pay to the
beneficiary a sum equal to 98 percent of the amount of
the loss sustained by the insured upon that loan.
(2) Exceptional performance.--
(A) Authority.--Where the Secretary
determines that an eligible lender, holder, or
servicer has a compliance performance rating
that equals or exceeds 97 percent, the
Secretary shall designate that eligible lender,
holder, or servicer, as the case may be, for
exceptional performance.
(B) Compliance performance rating.--For
purposes of subparagraph (A), a compliance
performance rating is determined with respect
to compliance with due diligence in the
disbursement, servicing, and collection of
loans under this subpart for each year for
which the determination is made. Such rating
shall be equal to the percentage of all due
diligence requirements applicable to each loan,
on average, as established by the Secretary,
with respect to loans serviced during the
period by the eligible lender, holder, or
servicer.
(C) Annual audits for lenders, holders, and
servicers.--Each eligible lender, holder, or
servicer desiring a designation under
subparagraph (A) shall have an annual financial
and compliance audit conducted with respect to
the loan portfolio of such eligible lender,
holder, or servicer, by a qualified independent
organization from a list of qualified
organizations identified by the Secretary and
in accordance with standards established by the
Secretary. The standards shall measure the
lender's, holder's, or servicer's compliance
with due diligence standards and shall include
a defined statistical sampling technique
designed to measure the performance rating of
the eligible lender, holder, or servicer for
the purpose of this section. Each eligible
lender, holder, or servicer shall submit the
audit required by this section to the
Secretary.
(D) Secretary's determinations.--The
Secretary shall make the determination under
subparagraph (A) based upon the audits
submitted under this paragraph and any
information in the possession of the Secretary
or submitted by any other agency or office of
the Federal Government.
(E) Quarterly compliance audit.--To
maintain its status as an exceptional
performer, the lender, holder, or servicer
shall undergo a quarterly compliance audit at
the end of each quarter (other than the quarter
in which status as an exceptional performer is
established through a financial and compliance
audit, as described in subparagraph (C)), and
submit the results of such audit to the
Secretary. The compliance audit shall review
compliance with due diligence requirements for
the period beginning on the day after the
ending date of the previous audit, in
accordance with standards determined by the
Secretary.
(F) Revocation authority.--The Secretary
shall revoke the designation of a lender,
holder, or servicer under subparagraph (A) if
any quarterly audit required under subparagraph
(E) is not received by the Secretary by the
date established by the Secretary or if the
audit indicates the lender, holder, or servicer
has failed to meet the standards for
designation as an exceptional performer under
subparagraph (A). A lender, holder, or servicer
receiving a compliance audit not meeting the
standard for designation as an exceptional
performer may reapply for designation under
subparagraph (A) at any time.
(G) Documentation.--Nothing in this section
shall restrict or limit the authority of the
Secretary to require the submission of claims
documentation evidencing servicing performed on
loans, except that the Secretary may not
require exceptional performers to submit
greater documentation than that required for
lenders, holders, and servicers not designated
under subparagraph (A).
(H) Cost of audits.--Each eligible lender,
holder, or servicer shall pay for all the costs
associated with the audits required under this
section.
(I) Additional revocation authority.--
Notwithstanding any other provision of this
section, a designation under subparagraph (A)
may be revoked at any time by the Secretary if
the Secretary determines that the eligible
lender, holder, or servicer has failed to
maintain an overall level of compliance
consistent with the audit submitted by the
eligible lender, holder, or servicer under this
paragraph or if the Secretary asserts that the
lender, holder, or servicer may have engaged in
fraud in securing designation under
subparagraph (A) or is failing to service loans
in accordance with program requirements.
(J) Noncompliance.--A lender, holder, or
servicer designated under subparagraph (A) that
fails to service loans or otherwise comply with
applicable program regulations shall be
considered in violation of the Federal False
Claims Act.
(b) Subrogation.--Upon payment by the Secretary of the
amount of the loss pursuant to subsection (a), the United
States shall be subrogated for all of the rights of the holder
of the obligation upon the insured loan and shall be entitled
to an assignment of the note or other evidence of the insured
loan by the insurance beneficiary. If the net recovery made by
the Secretary on a loan after deduction of the cost of that
recovery (including reasonable administrative costs) exceeds
the amount of the loss, the excess shall be paid over to the
insured. The Secretary may sell without recourse to eligible
lenders (or other entities that the Secretary determines are
capable of dealing in such loans) notes or other evidence of
loans received through assignment under the first sentence.
(c) Forbearance.--Nothing in this section or in this
subpart shall be construed to preclude any forbearance for the
benefit of the borrower which may be agreed upon by the parties
to the insured loan and approved by the Secretary or to
preclude forbearance by the Secretary in the enforcement of the
insured obligation after payment on that insurance.
(d) Reasonable Care and Diligence Regarding Loans.--Nothing
in this section or in this subpart shall be construed to excuse
the eligible lender or holder of a federally insured loan from
exercising reasonable care and diligence in the making of loans
under the provisions of this subpart and from exercising a
substantial effort in the collection of loans under the
provisions of this subpart. If the Secretary, after reasonable
notice and opportunity for hearing to an eligible lender, finds
that the lender has failed to exercise such care and diligence,
to exercise such substantial efforts, to make the reports and
statements required under section 706(a)(3), or to pay the
required Federal loan insurance premiums, he shall disqualify
that lender from obtaining further Federal insurance on loans
granted pursuant to this subpart until he is satisfied that its
failure has ceased and finds that there is reasonable assurance
that the lender will in the future exercise necessary care and
diligence, exercise substantial effort, or comply with such
requirements, as the case may be.
(e) Definitions.--For purposes of this section:
(1) The term ``insurance beneficiary'' means the
insured or its authorized assignee in accordance with
section 706(c).
(2) The term ``amount of the loss'' means, with
respect to a loan, unpaid balance of the principal
amount and interest on such loan, less the amount of
any judgment collected pursuant to default proceedings
commenced by the eligible lender or holder involved.
(3) The term ``default'' includes only such
defaults as have existed for 120 days.
(4) The term ``servicer'' means any agency acting
on behalf of the insurance beneficiary.
(f) Reductions in Federal Reimbursements or Payments for
Defaulting Borrowers.--The Secretary shall, after notice and
opportunity for a hearing, cause to be reduced Federal
reimbursements or payments for health services under any
Federal law to borrowers who are practicing their professions
and have defaulted on their loans insured under this subpart in
amounts up to the remaining balance of such loans. Procedures
for reduction of payments under the medicare program are
provided under section 1892 of the Social Security Act.
Notwithstanding such section 1892, any funds recovered under
this subsection shall be deposited in the insurance fund
established under section 710.
(g) Conditions for Discharge of Debt in Bankruptcy.--
Notwithstanding any other provision of Federal or State law, a
debt that is a loan insured under the authority of this subpart
may be released by a discharge in bankruptcy under any chapter
of title 11, United States Code, only if such discharge is
granted--
(1) after the expiration of the seven-year period
beginning on the first date when repayment of such loan
is required, exclusive of any period after such date in
which the obligation to pay installments on the loan is
suspended;
(2) upon a finding by the Bankruptcy Court that the
nondischarge of such debt would be unconscionable; and
(3) upon the condition that the Secretary shall not
have waived the Secretary's rights to apply subsection
(f) to the borrower and the discharged debt.
(h) Requirement Regarding Actions for Default.--
(1) In general.--With respect to the default by a
borrower on any loan covered by Federal loan insurance
under this subpart, the Secretary shall, under
subsection (a), require an eligible lender or holder to
commence and prosecute an action for such default
unless--
(A) in the determination of the Secretary--
(i) the eligible lender or holder
has made reasonable efforts to serve
process on the borrower involved and
has been unsuccessful with respect to
such efforts, or
(ii) prosecution of such an action
would be fruitless because of the
financial or other circumstances of the
borrower;
(B) for such loans made before the date of
the enactment of the Health Professions
Reauthorization Act of 1988, the loan involved
was made in an amount of less than $5,000; or
(C) for such loans made after such date,
the loan involved was made in an amount of less
than $2,500.
(2) Relationship to claim for payment.--With
respect to an eligible lender or holder that has
commenced an action pursuant to subsection (a), the
Secretary shall make the payment required in such
subsection, or deny the claim for such payment, not
later than 60 days after the date on which the
Secretary determines that the lender or holder has made
reasonable efforts to secure a judgment and collect on
the judgment entered into pursuant to this subsection.
(3) State court judgments.--With respect to any
State court judgment that is obtained by a lender or
holder against a borrower for default on a loan insured
under this subpart and that is subrogated to the United
States under subsection (b), any United States attorney
may register such judgment with the Federal courts for
enforcement.
(i) Inapplicability of Federal and State Statute of
Limitations on Actions for Loan Collection.--Notwithstanding
any other provision of Federal or State law, there shall be no
limitation on the period within which suit may be filed, a
judgment may be enforced, or an offset, garnishment, or other
action may be initiated or taken by the Secretary, the Attorney
General, or other administrative head of another Federal
agency, as the case may be, for the repayment of the amount due
from a borrower on a loan made under this subpart that has been
assigned to the Secretary under subsection (b).
(j) School Collection Assistance.--An institution or
postgraduate training program attended by a borrower may assist
in the collection of any loan of that borrower made under this
subpart which becomes delinquent, including providing
information concerning the borrower to the Secretary and to
past and present lenders and holders of the borrower's loans,
contacting the borrower in order to encourage repayment, and
withholding services in accordance with regulations issued by
the Secretary under section 715(a)(7). The institution or
postgraduate training program shall not be subject to section
809 of the Fair Debt Collection Practices Act for purposes of
carrying out activities authorized by this section.
SEC. 708. [292G] RISK-BASED PREMIUMS.
(a) Authority.--With respect to a loan made under this
subpart on or after January 1, 1993, the Secretary, in
accordance with subsection (b), shall assess a risk-based
premium on an eligible borrower and, if required under this
section, an eligible institution that is based on the default
rate of the eligible institution involved (as defined in
section 719).
(b) Assessment of Premium.--Except as provided in
subsection (d)(2), the risk-based premium to be assessed under
subsection (a) shall be as follows:
(1) Low-risk rate.--With respect to an eligible
borrower seeking to obtain a loan for attendance at an
eligible institution that has a default rate of not to
exceed five percent, such borrower shall be assessed a
risk-based premium in an amount equal to 6 percent of
the principal amount of the loan.
(2) Medium-risk rate.--
(A) In general.--With respect to an
eligible borrower seeking to obtain a loan for
attendance at an eligible institution that has
a default rate of in excess of five percent but
not to exceed 10 percent--
(i) such borrower shall be assessed
a risk-based premium in an amount equal
to 8 percent of the principal amount of
the loan; and
(ii) such institution shall be
assessed a risk-based premium in an
amount equal to 5 percent of the
principal amount of the loan.
(B) Default management plan.--An
institution of the type described in
subparagraph (A) shall prepare and submit to
the Secretary for approval, an annual default
management plan, that shall specify the
detailed short-term and long-term procedures
that such institution will have in place to
minimize defaults on loans to borrowers under
this subpart. Under such plan the institution
shall, among other measures, provide an exit
interview to all borrowers that includes
information concerning repayment schedules,
loan deferments, forbearance, and the
consequences of default.
(3) High-risk rate.--
(A) In general.--With respect to an
eligible borrower seeking to obtain a loan for
attendance at an eligible institution that has
a default rate of in excess of 10 percent but
not to exceed 20 percent--
(i) such borrower shall be assessed
a risk-based premium in an amount equal
to 8 percent of the principal amount of
the loan; and
(ii) such institution shall be
assessed a risk-based premium in an
amount equal to 10 percent of the
principal amount of the loan.
(B) Default management plan.--An
institution of the type described in
subparagraph (A) shall prepare and submit to
the Secretary for approval a plan that meets
the requirements of paragraph (2)(B).
(4) Ineligibility.--An individual shall not be
eligible to obtain a loan under this subpart for
attendance at an institution that has a default rate in
excess of 20 percent.
(c) Reduction of Risk-Based Premium.--Lenders shall reduce
by 50 percent the risk-based premium to eligible borrowers if a
credit worthy parent or other responsible party co-signs the
loan note.
(d) Administrative Waivers.--
(1) Hearing.--The Secretary shall afford an
institution not less than one hearing, and may consider
mitigating circumstances, prior to making such
institution ineligible for participation in the program
under this subpart.
(2) Exceptions.--In carrying out this section with
respect to an institution, the Secretary may grant an
institution a waiver of requirements of paragraphs (2)
through (4) of subsection (b) if the Secretary
determines that the default rate for such institution
is not an accurate indicator because the volume of the
loans under this subpart made by such institution has
been insufficient.
(3) Transition for certain institutions.--During
the 3-year period beginning on the effective date of
the Health Professions Education Extension Amendments
of 1992--
(A) subsection (b)(4) shall not apply with
respect to any eligible institution that is a
Historically Black College or University; and
(B) any such institution that has a default
rate in excess of 20 percent, and any eligible
borrower seeking a loan for attendance at the
institution, shall be subject to subsection
(b)(3) to the same extent and in the same
manner as eligible institutions and borrowers
described in such subsection.
(e) Payoff To Reduce Risk Category.--An institution may pay
off the outstanding principal and interest owed by the
borrowers of such institution who have defaulted on loans made
under this subpart in order to reduce the risk category of the
institution.
SEC. 709. [292H] OFFICE FOR HEALTH EDUCATION ASSISTANCE LOAN DEFAULT
REDUCTION.
(a) Establishment.--The Secretary shall establish, within
the Division of Student Assistance of the Bureau of Health
Professions, an office to be known as the Office for Health
Education Assistance Loan Default Reduction (in this section
referred to as the ``Office'').
(b) Purpose and Functions.--It shall be the purpose of the
Office to achieve a reduction in the number and amounts of
defaults on loans guaranteed under this subpart. In carrying
out such purpose the Office shall--
(1) conduct analytical and evaluative studies
concerning loans and loan defaults;
(2) carry out activities designed to reduce loan
defaults;
(3) respond to special circumstances that may exist
in the financial lending environment that may lead to
loan defaults;
(4) coordinate with other Federal entities that are
involved with student loan programs, including--
(A) with respect to the Department of
Education, in the development of a single
student loan application form, a single student
loan deferment form, a single disability form,
and a central student loan database; and
(B) with respect to the Department of
Justice, in the recovery of payments from
health professionals who have defaulted on
loans guaranteed under this subpart; and
(5) provide technical assistance to borrowers,
lenders, holders, and institutions concerning
deferments and collection activities.
(c) Additional Duties.--In conjunction with the report
submitted under subsection (b), the Office shall--
(1) compile, and publish in the Federal Register, a
list of the borrowers who are in default under this
subpart; and
(2) send the report and notices of default with
respect to these borrowers to relevant Federal agencies
and to schools, school associations, professional and
specialty associations, State licensing boards,
hospitals with which such borrowers may be associated,
and any other relevant organizations.
(d) Allocation of Funds for Office.--In the case of amounts
reserved under section 710(a)(2)(B) for obligation under this
subsection, the Secretary may obligate the amounts for the
purpose of administering the Office, including 7 full-time
equivalent employment positions for such Office. With respect
to such purpose, amounts made available under the preceding
sentence are in addition to amounts made available to the
Health Resources and Services Administration for program
management for the fiscal year involved. With respect to such
employment positions, the positions are in addition to the
number of full-time equivalent employment positions that
otherwise is authorized for the Department of Health and Human
Services for the fiscal year involved.
SEC. 710. [292I] INSURANCE ACCOUNT.
(a) In General.--
(1) Establishment.--There is hereby established a
student loan insurance account (in this section
referred to as the ``Account'') which shall be
available without fiscal year limitation to the
Secretary for making payments in connection with the
collection and default of loans insured under this
subpart by the Secretary.
(2) Funding.--
(A) Except as provided in subparagraph (B),
all amounts received by the Secretary as
premium charges for insurance and as receipts,
earnings, or proceeds derived from any claim or
other assets acquired by the Secretary in
connection with his operations under this
subpart, and any other moneys, property, or
assets derived by the Secretary from the
operations of the Secretary in connection with
this section, shall be deposited in the
Account.
(B) With respect to amounts described in
subparagraph (A) that are received by the
Secretary for fiscal year 1993 and subsequent
fiscal years, the Secretary may, before
depositing such amounts in the Account, reserve
from the amounts each such fiscal year not more
than $1,000,000 for obligation under section
709(d).
(3) Expenditures.--All payments in connection with
the default of loans insured by the Secretary under
this subpart shall be paid from the Account.
(b) Contingent Authority for Issuance of Notes or Other
Obligations.--If at any time the moneys in the Account are
insufficient to make payments in connection with the collection
or default of any loan insured by the Secretary under this
subpart, the Secretary of the Treasury may lend the Account
such amounts as may be necessary to make the payments involved,
subject to the Federal Credit Reform Act of 1990.
SEC. 711. [292J] POWERS AND RESPONSIBILITIES OF SECRETARY.
(a) In General.--In the performance of, and with respect
to, the functions, powers, and duties vested in the Secretary
by this subpart, the Secretary is authorized as follows:
(1) To prescribe such regulations as may be
necessary to carry out the purposes of this subpart.
(2) To sue and be sued in any district court of the
United States. Such district courts shall have
jurisdiction of civil actions arising under this
subpart without regard to the amount in controversy,
and any action instituted under this subsection by or
against the Secretary shall survive notwithstanding any
change in the person occupying the office of Secretary
or any vacancy in that office. No attachment,
injunction, garnishment, or other similar process,
mesne or final, shall be issued against the Secretary
or property under the control of the Secretary. Nothing
herein shall be constructed to except litigation
arising out of activities under this subpart from the
application of sections 517 and 547 of title 28 of the
United States Code.
(3) To include in any contract for Federal loan
insurance such terms, conditions, and covenants
relating to repayment of principal and payments of
interest, relating to his obligations and rights and to
those of eligible lenders, and borrowers in case of
default, and relating to such other matters as the
Secretary determines to be necessary to assure that the
purposes of this subpart will be achieved. Any term,
condition, and covenant made pursuant to this paragraph
or any other provisions of this subpart may be modified
by the Secretary if the Secretary determines that
modification is necessary to protect the financial
interest of the United States.
(4) Subject to the specific limitations in the
subpart, to consent to the modification of any note or
other instrument evidencing a loan which has been
insured by him under this subpart (including
modifications with respect to the rate of interest,
time of payment of any installment of principal and
interest or any portion thereof, or any other
provision).
(5) To enforce, pay, compromise, waive, or release
any right, title, claim, lien, or demand, however
acquired, including any equity or any right or \1\
redemption.
---------------------------------------------------------------------------
\1\ So in law. See section 102 of Public Law 102-408 (106 Stat.
1994). Probably should be ``right of redemption''.
---------------------------------------------------------------------------
(b) Annual Budget; Accounts.--The Secretary shall, with
respect to the financial operations arising by reason of this
subpart--
(1) prepare annually and submit a budget program as
provided for wholly owned Government corporations by
the Government Corporation Control Act; and
(2) maintain with respect to insurance under this
subpart an integral set of accounts.
SEC. 712. [292K] PARTICIPATION BY FEDERAL CREDIT UNIONS IN FEDERAL,
STATE, AND PRIVATE STUDENT LOAN INSURANCE PROGRAMS.
Notwithstanding any other provision of law, Federal credit
unions shall, pursuant to regulations of the Administrator of
the National Credit Union Administration, have power to make
insured loans to eligible students in accordance with the
provisions of this subpart relating to Federal insured loans.
SEC. 713. [292L] DETERMINATION OF ELIGIBLE STUDENTS.
For purposes of determining eligible students under this
part, in the case of a public school in a State that offers an
accelerated, integrated program of study combining
undergraduate premedical education and medical education
leading to advanced entry, by contractual agreement, into an
accredited four-year school of medicine which provides the
remaining training leading to a degree of doctor of medicine,
whenever in this part a provision refers to a student at a
school of medicine, such reference shall include only a student
enrolled in any of the last four years of such accelerated,
integrated program of study.
SEC. 714. [292M] REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR
DISABLED BORROWERS.
If a borrower who has received a loan dies or becomes
permanently and totally disabled (as determined in accordance
with regulations of the Secretary), the Secretary shall
discharge the borrower's liability on the loan by repaying the
amount owed on the loan from the account established under
section 710.
SEC. 715. [292N] ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.
(a) In General.--Notwithstanding any other provision of
this subpart, the Secretary is authorized to prescribe such
regulations as may be necessary to provide for--
(1) a fiscal audit of an eligible institution with
regard to any funds obtained from a borrower who has
received a loan insured under this subpart;
(2) the establishment of reasonable standards of
financial responsibility and appropriate institutional
capability for the administration by an eligible
institution of a program of student financial aid with
respect to funds obtained from a student who has
received a loan insured under this subpart;
(3) the limitation, suspension, or termination of
the eligibility under this subpart of any otherwise
eligible institution, whenever the Secretary has
determined, after notice and affording an opportunity
for hearing, that such institution has violated or
failed to carry out any regulation prescribed under
this subpart;
(4) the collection of information from the
borrower, lender, or eligible institution to assure
compliance with the provisions of section 705;
(5) the assessing of tuition or fees to borrowers
in amounts that are the same or less than the amount of
tuition and fees assessed to nonborrowers;
(6) the submission, by the institution or the
lender to the Office of Health Education Assistance
Loan Default Reduction, of information concerning each
loan made under this subpart, including the date when
each such loan was originated, the date when each such
loan is sold, the identity of the loan holder and
information concerning a change in the borrower's
status;
(7) the withholding of services, including academic
transcripts, financial aid transcripts, and alumni
services, by an institution from a borrower upon the
default of such borrower of a loan under this subpart,
except in case of a borrower who has filed for
bankruptcy; and
(8) the offering, by the lender to the borrower, of
a variety of repayment options, including fixed-rate,
graduated repayment with negative amortization
permitted, and income dependent payments for a limited
period followed by level monthly payments.
(b) Recording by Institution of Information on Students.--
The Secretary shall require an eligible institution to record,
and make available to the lender and to the Secretary upon
request, the name, address, postgraduate destination, and other
reasonable identifying information for each student of such
institution who has a loan insured under this subpart.
(c) Workshop for Student Borrowers.--Each participating
eligible institution must have, at the beginning of each
academic year, a workshop concerning the provisions of this
subpart that all student borrowers shall be required to attend.
SEC. 719. [292O] DEFINITIONS.
For purposes of this subpart:
(1) The term ``eligible institution'' means, with
respect to a fiscal year, a school of medicine,
osteopathic medicine, dentistry, veterinary medicine,
optometry, podiatric medicine, pharmacy, public health,
allied health, or chiropractic, or a graduate program
in health administration or behavioral and mental
health practice, including clinical psychology.
(2) The term ``eligible lender'' means an eligible
institution that became a lender under this subpart
prior to September 15, 1992, an agency or
instrumentality of a State, a financial or credit
institution (including an insurance company) which is
subject to examination and supervision by an agency of
the United States or of any State, a pension fund
approved by the Secretary for this purpose, or a
nonprofit private entity designated by the State,
regulated by the State, and approved by the Secretary.
(3) The term ``line of credit'' means an
arrangement or agreement between the lender and the
borrower whereby a loan is paid out by the lender to
the borrower in annual installments, or whereby the
lender agrees to make, in addition to the initial loan,
additional loans in subsequent years.
(4) The term ``school of allied health'' means a
program in a school of allied health (as defined in
section 799) which leads to a masters' degree or a
doctoral degree.
(5)(A) The term ``default rate'', in the case of an
eligible entity, means the percentage constituted by
the ratio of--
(i) the principal amount of loans insured
under this subpart--
(I) that are made with respect to
the entity and that enter repayment
status after April 7, 1987; and
(II) for which amounts have been
paid under section 707(a) to insurance
beneficiaries, exclusive of any loan
for which amounts have been so paid as
a result of the death or total and
permanent disability of the borrower;
exclusive of any loan for which the
borrower begins payments to the
Secretary on the loan pursuant to
section 707(b) and maintains payments
for 12 consecutive months in accordance
with the agreement involved (with the
loan subsequently being included or
excluded, as the case may be, as
amounts paid under section 707(a)
according to whether further defaults
occur and whether with respect to the
default involved compliance with such
requirement regarding 12 consecutive
months occurs); and exclusive of any
loan on which payments may not be
recovered by reason of the obligation
under the loan being discharged in
bankruptcy under title 11, United
States Code; to
(ii) the total principal amount of loans
insured under this subpart that are made with
respect to the entity and that enter repayment
status after April 7, 1987.
(B) For purposes of subparagraph (A), a loan
insured under this subpart shall be considered to have
entered repayment status if the applicable period
described in subparagraph (B) of section 705(a)(2)
regarding the loan has expired (without regard to
whether any period described in subparagraph (C) of
such section is applicable regarding the loan).
(C) For purposes of subparagraph (A), the term
``eligible entity'' means an eligible institution, an
eligible lender, or a holder, as the case may be.
(D) For purposes of subparagraph (A), a loan is
made with respect to an eligible entity if--
(i) in the case of an eligible institution, the
loan was made to students of the institution;
(ii) in the case of an eligible lender, the loan
was made by the lender; and
(iii) in the case of a holder, the loan was
purchased by the holder.
SEC. 720. [292P] AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For fiscal year 1993 and subsequent fiscal
years, there are authorized to be appropriated such sums as may
be necessary for the adequacy of the student loan insurance
account under this subpart and for the purpose of administering
this subpart.
(b) Availability of Sums.--Sums appropriated under
subsection (a) shall remain available until expended.
Subpart II--Federally-Supported Student Loan Funds
SEC. 721. [292Q] AGREEMENTS FOR OPERATION OF SCHOOL LOAN FUNDS.
(a) Fund Agreements.--The Secretary is authorized to enter
into an agreement for the establishment and operation of a
student loan fund in accordance with this subpart with any
public or other nonprofit school of medicine, osteopathic
medicine, dentistry, pharmacy, podiatric medicine, optometry,
or veterinary medicine.
(b) Requirements.--Each agreement entered into under this
section shall--
(1) provide for establishment of a student loan
fund by the school;
(2) provide for deposit in the fund of--
(A) the Federal capital contributions to
the fund;
(B) an amount equal to not less than one-
ninth of such Federal capital contributions,
contributed by such institution;
(C) collections of principal and interest
on loans made from the fund;
(D) collections pursuant to section 722(j);
and
(E) any other earnings of the fund;
(3) provide that the fund shall be used only for
loans to students of the school in accordance with the
agreement and for costs of collection of such loans and
interest thereon;
(4) provide that loans may be made from such funds
only to students pursuing a full-time course of study
at the school leading to a degree of doctor of
medicine, doctor of dentistry or an equivalent degree,
doctor of osteopathy, bachelor of science in pharmacy
or an equivalent degree, doctor of pharmacy or an
equivalent degree, doctor of podiatric medicine or an
equivalent degree, doctor of optometry or an equivalent
degree, or doctor of veterinary medicine or an
equivalent degree;
(5) provide that the school shall advise, in
writing, each applicant for a loan from the student
loan fund of the provisions of section 722 under which
outstanding loans from the student loan fund may be
paid (in whole or in part) by the Secretary; and
(6) contain such other provisions as are necessary
to protect the financial interests of the United
States.
(c) Failure of School To Collect Loans.--
(1) In general.--Any standard established by the
Secretary by regulation for the collection by schools
of medicine, osteopathic medicine, dentistry, pharmacy,
podiatric medicine, optometry, or veterinary medicine
of loans made pursuant to loan agreements under this
subpart shall provide that the failure of any such
school to collect such loans shall be measured in
accordance with this subsection. This subsection may
not be construed to require such schools to reimburse
the student loan fund under this subpart for loans that
became uncollectible prior to August 1985 or to
penalize such schools with respect to such loans.
(2) Extent of failure.--The measurement of a
school's failure to collect loans made under this
subpart shall be the ratio (stated as a percentage)
that the defaulted principal amount outstanding of such
school bears to the matured loans of such school.
(3) Definitions.--For purposes of this subsection:
(A) The term ``default'' means the failure
of a borrower of a loan made under this subpart
to--
(i) make an installment payment
when due; or
(ii) comply with any other term of
the promissory note for such loan,
except that a loan made under this subpart
shall not be considered to be in default if the
loan is discharged in bankruptcy or if the
school reasonably concludes from written
contracts with the borrower that the borrower
intends to repay the loan.
(B) The term ``defaulted principal amount
outstanding'' means the total amount borrowed
from the loan fund of a school that has reached
the repayment stage (minus any principal amount
repaid or canceled) on loans--
(i) repayable monthly and in
default for at least 120 days; and
(ii) repayable less frequently than
monthly and in default for at least 180
days;
(C) The term ``grace period'' means the
period of one year beginning on the date on
which the borrower ceases to pursue a full-time
course of study at a school of medicine,
osteopathic medicine, dentistry, pharmacy,
podiatric medicine, optometry, or veterinary
medicine; and
(D) The term ``matured loans'' means the
total principal amount of all loans made by a
school under this subpart minus the total
principal amount of loans made by such school
to students who are--
(i) enrolled in a full-time course
of study at such school; or
(ii) in their grace period.
SEC. 722. [292R] LOAN PROVISIONS.
(a) Amount of Loan.--
(1) In general.--Loans from a student loan fund
(established under an agreement with a school under
section 721) may not, subject to paragraph (2), exceed
for any student for a school year (or its equivalent)
the cost of attendance (including tuition, other
reasonable educational expenses, and reasonable living
costs) for that year at the educational institution
attended by the student (as determined by such
educational institution).
(2) Third and fourth years of medical school.--For
purposes of paragraph (1), the amount of the loan may,
in the case of the third or fourth year of a student at
a school of medicine or osteopathic medicine, be
increased to the extent necessary to pay the balances
of loans that, from sources other than the student loan
fund under section 721, were made to the individual for
attendance at the school. The authority to make such an
increase is subject to the school and the student
agreeing that such amount (as increased) will be
expended to pay such balances.
(b) Terms and Conditions.--Subject to section 723, any such
loans shall be made on such terms and conditions as the school
may determine, but may be made only to a student--
(1) who is in need of the amount thereof to pursue
a full-time course of study at the school leading to a
degree of doctor of medicine, doctor of dentistry or an
equivalent degree, doctor of osteopathy, bachelor of
science in pharmacy or an equivalent degree, doctor of
pharmacy or an equivalent degree, doctor of podiatric
medicine or an equivalent degree, doctor of optometry
or an equivalent degree, or doctor of veterinary
medicine or an equivalent degree; and
(2) who, if required under section 3 of the
Military Selective Service Act to present himself for
and submit to registration under such section, has
presented himself and submitted to registration under
such section.
(c) Repayment; Exclusions From Repayment Period.--Such
loans shall be repayable in equal or graduated periodic
installments (with the right of the borrower to accelerate
repayment) over the period of not less than 10 years nor more
than 25 years, at the discretion of the institution, which
begins one year after the student ceases to pursue a full-time
course of study at a school of medicine, osteopathic medicine,
dentistry, pharmacy, podiatry, optometry, or veterinary
medicine, excluding from such period--
(1) all periods--
(A) not in excess of three years of active
duty performed by the borrower as a member of a
uniformed service;
(B) not in excess of three years during
which the borrower serves as a volunteer under
the Peace Corps Act;
(C) during which the borrower participates
in advanced professional training, including
internships and residencies; and
(D) during which the borrower is pursuing a
full-time course of study at such a school; and
(2) a period--
(A) not in excess of two years during which
a borrower who is a full-time student in such a
school leaves the school, with the intent to
return to such school as a full-time student,
in order to engage in a full-time educational
activity which is directly related to the
health profession for which the borrower is
preparing, as determined by the Secretary; or
(B) not in excess of two years during which
a borrower who is a graduate of such a school
is a participant in a fellowship training
program or a full-time educational activity
which--
(i) is directly related to the
health profession for which such
borrower prepared at such school, as
determined by the Secretary; and
(ii) may be engaged in by the
borrower during such a two-year period
which begins within twelve months after
the completion of the borrower's
participation in advanced professional
training described in paragraph (1)(C)
or prior to the completion of such
borrower's participation in such
training.
(d) Cancellation of Liability.--The liability to repay the
unpaid balance of such a loan and accrued interest thereon
shall be canceled upon the death of the borrower, or if the
Secretary determines that he has become permanently, and
totally disabled.
(e) Rate of Interest.--Such loans shall bear interest, on
the unpaid balance of the loan, computed only for periods for
which the loan is repayable, at the rate of 5 percent per year.
(f) Security or Endorsement.--Loans shall be made under
this subpart without security or endorsement, except that if
the borrower is a minor and the note or other evidence of
obligation executed by him would not, under the applicable law,
create a binding obligation, either security or endorsement may
be required.
(g) Transferring and Assigning Loans.--No note or other
evidence of a loan made under this subpart may be transferred
or assigned by the school making the loan except that, if the
borrowers transfer to another school participating in the
program under this subpart, such note or other evidence of a
loan may be transferred to such other school.
(h) Charge With Respect to Insurance for Certain
Cancellations.--Subject to regulations of the Secretary, a
school may assess a charge with respect to loans made this \1\
subpart to cover the costs of insuring against cancellation of
liability under subsection (d).
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\1\ So in law. See section 102 of Public Law 102-408 (106 Stat.
1994). Probably should be ``made under this subpart''.
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(i) Charge With Respect to Late Payments.--Subject to
regulations of the Secretary, and in accordance with this
section, a school shall assess a charge with respect to a loan
made under this subpart for failure of the borrower to pay all
or any part of an installment when it is due and, in the case
of a borrower who is entitled to deferment of the loan under
subsection (c), for any failure to file timely and satisfactory
evidence of such entitlement. No such charge may be made if the
payment of such installment or the filing of such evidence is
made within 60 days after the date on which such installment or
filing is due. The amount of any such charge may not exceed an
amount equal to 6 percent of the amount of such installment.
The school may elect to add the amount of any such charge to
the principal amount of the loan as of the first day after the
day on which such installment or evidence was due, or to make
the amount of the charge payable to the school not later than
the due date of the next installment after receipt by the
borrower of notice of the assessment of the charge.
(j) Authority of Schools Regarding Rate of Payment.--A
school may provide, in accordance with regulations of the
Secretary, that during the repayment period of a loan from a
loan fund established pursuant to an agreement under this
subpart payments of principal and interest by the borrower with
respect to all the outstanding loans made to him from loan
funds so established shall be at a rate equal to not less than
$40 per month.
(k) Authority Regarding Repayments by Secretary.--Upon
application by a person who received, and is under an
obligation to repay, any loan made to such person as a health
professions student to enable him to study medicine,
osteopathy, dentistry, veterinary medicine, optometry,
pharmacy, or podiatry, the Secretary may undertake to repay
(without liability to the applicant) all or any part of such
loan, and any interest or portion thereof outstanding thereon,
upon his determination, pursuant to regulations establishing
criteria therefor, that the applicant--
(1) failed to complete such studies leading to his
first professional degree;
(2) is in exceptionally needy circumstances;
(3) is from a low-income or disadvantaged family as
those terms may be defined by such regulations; and
(4) has not resumed, or cannot reasonably be
expected to resume, the study of medicine, osteopathy,
dentistry, veterinary medicine, optometry, pharmacy, or
podiatric medicine, within two years following the date
upon which he terminated such studies.
(l) Collection Efforts by Secretary.--The Secretary is
authorized to attempt to collect any loan which was made under
this subpart, which is in default, and which was referred to
the Secretary by a school with which the Secretary has an
agreement under this subpart, on behalf of that school under
such terms and conditions as the Secretary may prescribe
(including reimbursement from the school's student loan fund
for expenses the Secretary may reasonably incur in attempting
collection), but only if the school has complied with such
requirements as the Secretary may specify by regulation with
respect to the collection of loans under this subpart. A loan
so referred shall be treated as a debt subject to section 5514
of title 5, United States Code. Amounts collected shall be
deposited in the school's student loan fund. Whenever the
Secretary desires the institution of a civil action regarding
any such loan, the Secretary shall refer the matter to the
Attorney General for appropriate action.
(m) Elimination of Statute of Limitation for Loan
Collections.--
(1) Purpose.--It is the purpose of this subsection
to ensure that obligations to repay loans under this
section are enforced without regard to any Federal or
State statutory, regulatory, or administrative
limitation on the period within which debts may be
enforced.
(2) Prohibition.--Notwithstanding any other
provision of Federal or State law, no limitation shall
terminate the period within which suit may be filed, a
judgment may be enforced, or an offset, garnishment, or
other action may be initiated or taken by a school that
has an agreement with the Secretary pursuant to section
721 that is seeking the repayment of the amount due
from a borrower on a loan made under this subpart after
the default of the borrower on such loan.
SEC. 723. [292S] MEDICAL SCHOOLS AND PRIMARY HEALTH CARE.
(a) Requirements for Students.--
(1) In general.--Subject to the provisions of this
subsection, in the case of student loan funds
established under section 721 by schools of medicine or
osteopathic medicine, each agreement entered into under
such section with such a school shall provide (in
addition to the provisions required in subsection (b)
of such section) that the school will make a loan from
such fund to a student only if the student agrees--
(A) to enter and complete a residency
training program in primary health care not
later than 4 years after the date on which the
student graduates from such school; and
(B) to practice in such care for 10 years
(including residency training in primary health
care) or through the date on which the loan is
repaid in full, whichever occurs first.
(2) Inapplicability to certain students.--
(A) The requirement established in
paragraph (1) regarding the student loan fund
of a school does not apply to a student if--
(i) the first loan to the student
from such fund is made before July 1,
1993; or
(ii) the loan is made from--
(I) a Federal capital
contribution under section 721
that is made from amounts
appropriated under section
724(f) (in this section
referred to as an ``exempt
Federal capital
contribution''); or
(II) a school contribution
made under section 721 pursuant
to such a Federal capital
contribution (in this section
referred to as an ``exempt
school contribution'').
(B) A Federal capital contribution under
section 721 may not be construed as being an
exempt Federal capital contribution if the
contribution was made from amounts appropriated
before October 1, 1990. A school contribution
under section 721 may not be construed as being
an exempt school contribution if the
contribution was made pursuant to a Federal
capital contribution under such section that
was made from amounts appropriated before such
date.
(3) Noncompliance by student.--Each agreement
entered into with a student pursuant to paragraph (1)
shall provide that, if the student fails to comply with
such agreement, the loan involved will begin to accrue
interest at a rate of 2 percent per year greater than
the rate at which the student would pay if compliant in
such year.
(4) Waivers.--
(A) With respect to the obligation of an
individual under an agreement made under
paragraph (1) as a student, the Secretary shall
provide for the partial or total waiver or
suspension of the obligation whenever
compliance by the individual is impossible, or
would involve extreme hardship to the
individual, and if enforcement of the
obligation with respect to the individual would
be unconscionable.
(B) For purposes of subparagraph (A), the
obligation of an individual shall be waived
if--
(i) the status of the individual as
a student of the school involved is
terminated before graduation from the
school, whether voluntarily or
involuntarily; and
(ii) the individual does not, after
such termination, resume attendance at
the school or begin attendance at any
other school of medicine or osteopathic
medicine.
(C) If an individual resumes or begins
attendance for purposes of subparagraph (B),
the obligation of the individual under the
agreement under paragraph (1) shall be
considered to have been suspended for the
period in which the individual was not in
attendance.
(D) This paragraph may not be construed as
authorizing the waiver or suspension of the
obligation of a student to repay, in accordance
with section 722, loans from student loan funds
under section 721.
(b) Requirements for Schools.--
(1) In general.--Subject to the provisions of this
subsection, in the case of student loan funds
established under section 721 by schools of medicine or
osteopathic medicine, each agreement entered into under
such section with such a school shall provide (in
addition to the provisions required in subsection (b)
of such section) that, for the 1-year period ending on
June 30, 1997; \1\ and for the 1-year period ending on
June 30 of each subsequent fiscal year, the school will
meet not less than 1 of the conditions described in
paragraph (2) with respect to graduates of the school
whose date of graduation from the school occurred
approximately 4 years before the end of the 1-year
period involved.
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\1\ So in law. See section 2014(c)(2)(A)(i) of Public Law 103-43
(107 Stat. 216). The semicolon probably should be a comma.
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(2) Description of conditions.--With respect to
graduates described in paragraph (1) (in this paragraph
referred to as ``designated graduates''), the
conditions referred to in such paragraph for a school
for a 1-year period are as follows:
(A) Not less than 50 percent of designated
graduates of the school meet the criterion of
either being in a residency training program in
primary health care, or being engaged in a
practice in such care (having completed such a
program).
(B) Not less than 25 percent of the
designated graduates of the school meet such
criterion, and such percentage is not less than
5 percentage points above the percentage of
such graduates meeting such criterion for the
preceding 1-year period.
(C) In the case of schools of medicine or
osteopathic medicine with student loans funds
under section 721, the school involved is at or
above the 75th percentile of such schools whose
designated graduates meet such criterion.
(3) Determinations by secretary.--Not later than 90
days after the close of each 1-year period described in
paragraph (1), the Secretary shall make a determination
of whether the school involved has for such period
complied with such paragraph and shall in writing
inform the school of the determination. Such
determination shall be made only after consideration of
the report submitted to the Secretary by the school
under paragraph (6).
(4) Noncompliance by school.--
(A)(i) Subject to subparagraph (C), each
agreement under section 721 with a school of
medicine or osteopathic medicine shall provide
that, if the school fails to comply with
paragraph (1) for a 1-year period under such
paragraph, the school--
(I) will pay to the
Secretary the amount applicable
under subparagraph (B) for the
period; and
(II) will pay such amount
not later than 90 days after
the school is informed under
paragraph (3) of the
determination of the Secretary
regarding such period.
(ii) Any amount that a school is required
to pay under clause (i) may be paid from the
student loan fund of the school under section
721.
(B) For purposes of subparagraph (A), the
amount applicable for a school, subject to
subparagraph (C), is--
(i) for the 1-year period ending
June 30, 1997, an amount equal to 10
percent of the income received during
such period by the student loan fund of
the school under section 721;
(ii) for the 1-year period ending
June 30, 1998, an amount equal to 20
percent of the income received during
such period by the student loan fund;
and
(iii) for any subsequent 1-year
period under paragraph (1), an amount
equal to 30 percent of the income
received during such period by the
student loan fund.
(C) In determining the amount of income
that a student loan fund has received for
purposes of subparagraph (B), the Secretary
shall exclude any income derived from exempt
contributions. Payments made to the Secretary
under subparagraph (A) may not be made with
such contributions or with income derived from
such contributions.
(5) Expenditure of payments.--
(A) Amounts paid to the Secretary under
paragraph (4) shall be expended to make Federal
capital contributions to student loan funds
under section 721 of schools that are in
compliance with paragraph (1).
(B) A Federal capital contribution under
section 721 may not be construed as being an
exempt Federal capital contribution if the
contribution is made from payments under
subparagraph (A). A school contribution under
such section may not be construed as being an
exempt school contribution if the contribution
is made pursuant to a Federal capital
contribution from such payments.
(6) Reports by schools.--Each agreement under
section 721 with a school of medicine or osteopathic
medicine shall provide that the school will submit to
the Secretary a report for each 1-year period under
paragraph (1) that provides such information as the
Secretary determines to be necessary for carrying out
this subsection. Each such report shall include
statistics concerning the current training or practice
status of all graduates of such school whose date of
graduation from the school occurred approximately 4
years before the end of the 1-year period involved.
(c) Definitions.--For purposes of this section:
(1) The term ``exempt contributions'' means exempt
Federal capital contributions and exempt school
contributions.
(2) The term ``exempt Federal capital
contribution'' means a Federal capital contribution
described in subclause (I) of subsection (a)(2)(A)(ii).
(3) The term ``exempt school contribution'' means a
school contribution described in subclause (II) of
subsection (a)(2)(A)(ii).
(4) The term ``income'', with respect to a student
fund under section 721, means payments of principal and
interest on any loan made from the fund, and any other
earnings of the fund.
(5) The term ``primary health care'' means family
medicine, general internal medicine, general
pediatrics, preventive medicine, or osteopathic general
practice.
(d) Sense of Congress.--It is the sense of Congress that
funds repaid under the loan program under this section should
not be transferred to the Treasury of the United States or
otherwise used for any other purpose other than to carry out
this section.
SEC. 724. [292T] INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.
(a) Fund Agreements Regarding Certain Amounts.--With
respect to amounts appropriated under subsection (f), each
agreement entered into under section 721 with a school shall
provide (in addition to the provisions required in subsection
(b) of such section) that--
(1) any Federal capital contribution made to the
student loan fund of the school from such amounts,
together with the school contribution appropriate under
subsection (b)(2)(B) of such section to the amount of
the Federal capital contribution, will be utilized only
for the purpose of--
(A) making loans to individuals from
disadvantaged backgrounds; and
(B) the costs of the collection of the
loans and interest on the loans; and
(2) collections of principal and interest on loans
made pursuant to paragraph (1), and any other earnings
of the student loan fund attributable to amounts that
are in the fund pursuant to such paragraph, will be
utilized only for the purpose described in such
paragraph.
(b) Minimum Qualifications for Schools.--The Secretary may
not make a Federal capital contribution for purposes of
subsection (a) for a fiscal year unless the health professions
school involved--
(1) is carrying out a program for recruiting and
retaining students from disadvantaged backgrounds,
including racial and ethnic minorities; and
(2) is carrying out a program for recruiting and
retaining minority faculty.
(c) Certain Agreements Regarding Education of Students;
Date Certain for Compliance.--The Secretary may not make a
Federal capital contribution for purposes of subsection (a) for
a fiscal year unless the health professions school involved
agrees--
(1) to ensure that adequate instruction regarding
minority health issues is provided for in the curricula
of the school;
(2) with respect to health clinics providing
services to a significant number of individuals who are
from disadvantaged backgrounds, including members of
minority groups, to enter into arrangements with 1 or
more such clinics for the purpose of providing students
of the school with experience in providing clinical
services to such individuals;
(3) with respect to public or nonprofit private
secondary educational institutions and undergraduate
institutions of higher education, to enter into
arrangements with 1 or more such institutions for the
purpose of carrying out programs regarding the
educational preparation of disadvantaged students,
including minority students, to enter the health
professions and regarding the recruitment of such
individuals into the health professions;
(4) to establish a mentor program for assisting
disadvantaged students, including minority students,
regarding the completion of the educational
requirements for degrees from the school;
(5) to be carrying out each of the activities
specified in any of paragraphs (1) through (4) by not
later than 1 year after the date on which the first
Federal capital contribution is made to the school for
purposes of subsection (a); and
(6) to continue carrying out such activities, and
the activities specified in paragraphs (1) and (2) of
subsection (b), throughout the period during which the
student loan fund established pursuant to section
721(b) is in operation.
(d) Availability of Other Amounts.--With respect to Federal
capital contributions to student loan funds under agreements
under section 721(b), any such contributions made before
October 1, 1990, together with the school contributions
appropriate under paragraph (2)(B) of such section to the
amount of the Federal capital contributions, may be utilized
for the purpose of making loans to individuals from
disadvantaged backgrounds, subject to section 723(a)(2)(B).
(e) Definition.--For purposes of this section, the term
``disadvantaged'', with respect to an individual, shall be
defined by the Secretary.
(f) Authorization of Appropriations.--
(1) \1\ In general.--With respect to making Federal
capital contributions to student loan funds for
purposes of subsection (a), there is authorized to be
appropriated for such contributions $8,000,000 for each
of the fiscal years 1998 through 2002.
---------------------------------------------------------------------------
\1\ Effective October 1, 2002, this paragraph is repealed by
section 132(b) of Public Law 105-392 (112 Stat. 3575).
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(2) Special consideration for certain schools.--In
making Federal capital contributions to student loan
funds for purposes of subsection (a), the Secretary
shall give special consideration to health professions
schools that have enrollments of underrepresented
minorities above the national average for health
professions schools.
SEC. 725. [292U] ADMINISTRATIVE PROVISIONS.
The Secretary may agree to modifications of agreements or
loans made under this subpart, and may compromise, waive, or
release any right, title, claim, or demand of the United States
arising or acquired under this subpart.
SEC. 726. [292V] PROVISION BY SCHOOLS OF INFORMATION TO STUDENTS.
(a) In General.--With respect to loans made by a school
under this subpart after June 30, 1986, each school, in order
to carry out the provisions of sections 721 and 722, shall, at
any time such school makes such a loan to a student under this
subpart, provide thorough and adequate loan information on
loans made under this subpart to the student. The loan
information required to be provided to the student by this
subsection shall include--
(1) the yearly and cumulative maximum amounts that
may be borrowed by the student;
(2) the terms under which repayment of the loan
will begin;
(3) the maximum number of years in which the loan
must be repaid;
(4) the interest rate that will be paid by the
borrower and the minimum amount of the required monthly
payment;
(5) the amount of any other fees charged to the
borrower by the lender;
(6) any options the borrower may have for deferral,
cancellation, prepayment, consolidation, or other
refinancing of the loan;
(7) a definition of default on the loan and a
specification of the consequences which will result to
the borrower if the borrower defaults, including a
description of any arrangements which may be made with
credit bureau organizations;
(8) to the extent practicable, the effect of
accepting the loan on the eligibility of the borrower
for other forms of student assistance; and
(9) a description of the actions that may be taken
by the Federal Government to collect the loan,
including a description of the type of information
concerning the borrower that the Federal Government may
disclose to (A) officers, employees, or agents of the
Department of Health and Human Services, (B) officers,
employees, or agents of schools with which the
Secretary has an agreement under this subpart, or (C)
any other person involved in the collection of a loan
under this subpart.
(b) Statement Regarding Loan.--Each school shall,
immediately prior to the graduation from such school of a
student who receives a loan under this subpart after June 30,
1986, provide such student with a statement specifying--
(1) each amount borrowed by the student under this
subpart;
(2) the total amount borrowed by the student under
this subpart; and
(3) a schedule for the repayment of the amounts
borrowed under this subpart, including the number,
amount, and frequency of payments to be made.
SEC. 727. [292W] PROCEDURES FOR APPEAL OF TERMINATION OF AGREEMENTS.
In any case in which the Secretary intends to terminate an
agreement with a school under this subpart, the Secretary shall
provide the school with a written notice specifying such
intention and stating that the school may request a formal
hearing with respect to such termination. If the school
requests such a hearing within 30 days after the receipt of
such notice, the Secretary shall provide such school with a
hearing conducted by an administrative law judge.
SEC. 728. [292X] DISTRIBUTION OF ASSETS FROM LOAN FUNDS.
(a) Distribution After Termination of Fund.--If a school
terminates a loan fund established under an agreement pursuant
to section 721(b), or if the Secretary for good cause
terminates the agreement with the school, there shall be a
capital distribution as follows:
(1) The Secretary shall first be paid an amount
which bears the same ratio to such balance in such fund
on the date of termination of the fund as the total
amount of the Federal capital contributions to such
fund by the Secretary pursuant to section 721(b)(2)(A)
bears to the total amount in such fund derived from
such Federal capital contributions and from funds
deposited therein pursuant to section 721(b)(2)(B).
(2) The remainder of such balance shall be paid to
the school.
(b) Payment of Proportionate Share to Secretary.--If a
capital distribution is made under subsection (a), the school
involved shall, after the capital distribution, pay to the
Secretary, not less often than quarterly, the same
proportionate share of amounts received by the school in
payment of principal or interest on loans made from the loan
fund established pursuant to section 721(b) as was determined
by the Secretary under subsection (a).
SEC. 735. \1\ [292Y] GENERAL PROVISIONS.
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\1\ Title VII does not have sections 729 through 734. See section
102 of Public Law 102-408 (106 Stat. 1994, 2021).
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(a) Date Certain for Applications.--The Secretary shall
from time to time set dates by which schools must file
applications for Federal capital contributions.
(b) Contingent Reduction in Allotments.--If the total of
the amounts requested for any fiscal year in such applications
exceeds the amounts appropriated under this section for that
fiscal year, the allotment to the loan fund of each such school
shall be reduced to whichever of the following is the smaller:
(A) the amount requested in its application; or (B) an amount
which bears the same ratio to the amounts appropriated as the
number of students estimated by the Secretary to be enrolled in
such school during such fiscal year bears to the estimated
total number of students in all such schools during such year.
Amounts remaining after allotment under the preceding sentence
shall be reallotted in accordance with clause (B) of such
sentence among schools whose applications requested more than
the amounts so allotted to their loan funds, but with such
adjustments as may be necessary to prevent the total allotted
to any such school's loan fund from exceeding the total so
requested by it.
(c) Allotment of Excess Funds.--Funds available in any
fiscal year for payment to schools under this subpart which are
in excess of the amount appropriated pursuant to this section
for that year shall be allotted among schools in such manner as
the Secretary determines will best carry out the purposes of
this subpart.
(d) Payment of Installments to Schools.--Allotments to a
loan fund of a school shall be paid to it from time to time in
such installments as the Secretary determines will not result
in unnecessary accumulations in the loan fund at such school.
(e) Disposition of Funds Returned to Secretary.--
(1) Expenditure for federal capital
contributions.--Subject to section 723(b)(5), any
amounts from student loan funds under section 721 that
are returned to the Secretary by health professions
schools shall be expended to make Federal capital
contributions to such funds.
(2) Date certain for contributions.--Amounts
described in paragraph (1) that are returned to the
Secretary shall be obligated before the end of the
succeeding fiscal year.
(3) Preference in making contributions.--In making
Federal capital contributions to student loans funds
under section 721 for a fiscal year from amounts
described in paragraph (1), the Secretary shall give
preference to health professions schools of the same
disciplines as the health professions schools returning
such amounts for the period during which the amounts
expended for such contributions were received by the
Secretary. Any such amounts that, prior to being so
returned, were available only for the purpose of loans
under this subpart to individuals from disadvantaged
backgrounds shall be available only for such purpose.
(f) Funding for Certain Medical Schools.--
(1) Authorization of appropriations.--For the
purpose of making Federal capital contributions to
student loan funds established under section 721 by
schools of medicine or osteopathic medicine, there is
authorized to be appropriated $10,000,000 for each of
the fiscal years 1994 through 1996.
(2) Minimum requirements.--
(A) Subject to subparagraph (B), the
Secretary may make a Federal capital
contribution pursuant to paragraph (1) only if
the school of medicine or osteopathic medicine
involved meets the conditions described in
subparagraph (A) of section 723(b)(2) or the
conditions described in subparagraph (C) of
such section.
(B) For purposes of subparagraph (A), the
conditions referred to in such subparagraph
shall be applied with respect to graduates of
the school involved whose date of graduation
occurred approximately 3 years before June 30
of the fiscal year preceding the fiscal year
for which the Federal capital contribution
involved is made.
PART B--HEALTH PROFESSIONS TRAINING FOR DIVERSITY
SEC. 736. [293] CENTERS OF EXCELLENCE.
(a) In General.--The Secretary shall make grants to, and
enter into contracts with, designated health professions
schools described in subsection (c), and other public and
nonprofit health or educational entities, for the purpose of
assisting the schools in supporting programs of excellence in
health professions education for under-represented minority
individuals.
(b) Required Use of Funds.--The Secretary may not make a
grant under subsection (a) unless the designated health
professions school involved agrees, subject to subsection
(c)(1)(C), to expend the grant--
(1) to develop a large competitive applicant pool
through linkages with institutions of higher education,
local school districts, and other community-based
entities and establish an education pipeline for health
professions careers;
(2) to establish, strengthen, or expand programs to
enhance the academic performance of under-represented
minority students attending the school;
(3) to improve the capacity of such school to
train, recruit, and retain under-represented minority
faculty including the payment of such stipends and
fellowships as the Secretary may determine appropriate;
(4) to carry out activities to improve the
information resources, clinical education, curricula
and cultural competence of the graduates of the school,
as it relates to minority health issues;
(5) to facilitate faculty and student research on
health issues particularly affecting under-represented
minority groups, including research on issues relating
to the delivery of health care;
(6) to carry out a program to train students of the
school in providing health services to a significant
number of under-represented minority individuals
through training provided to such students at
community-based health facilities that--
(A) provide such health services; and
(B) are located at a site remote from the
main site of the teaching facilities of the
school; and
(7) to provide stipends as the Secretary determines
appropriate, in amounts as the Secretary determines
appropriate.
(c) Centers of Excellence.--
(1) Designated schools.--
(A) In general.--The designated health
professions schools referred to in subsection
(a) are such schools that meet each of the
conditions specified in subparagraphs (B) and
(C), and that--
(i) meet each of the conditions
specified in paragraph (2)(A);
(ii) meet each of the conditions
specified in paragraph (3);
(iii) meet each of the conditions
specified in paragraph (4); or
(iv) meet each of the conditions
specified in paragraph (5).
(B) General conditions.--The conditions
specified in this subparagraph are that a
designated health professions school--
(i) has a significant number of
under-represented minority individuals
enrolled in the school, including
individuals accepted for enrollment in
the school;
(ii) has been effective in
assisting under-represented minority
students of the school to complete the
program of education and receive the
degree involved;
(iii) has been effective in
recruiting under-represented minority
individuals to enroll in and graduate
from the school, including providing
scholarships and other financial
assistance to such individuals and
encouraging under-represented minority
students from all levels of the
educational pipeline to pursue health
professions careers; and
(iv) has made significant
recruitment efforts to increase the
number of under-represented minority
individuals serving in faculty or
administrative positions at the school.
(C) Consortium.--The condition specified in
this subparagraph is that, in accordance with
subsection (e)(1), the designated health
profession school involved has with other
health profession schools (designated or
otherwise) formed a consortium to carry out the
purposes described in subsection (b) at the
schools of the consortium.
(D) Application of criteria to other
programs.--In the case of any criteria
established by the Secretary for purposes of
determining whether schools meet the conditions
described in subparagraph (B), this section may
not, with respect to racial and ethnic
minorities, be construed to authorize, require,
or prohibit the use of such criteria in any
program other than the program established in
this section.
(2) Centers of excellence at certain historically
black colleges and universities.--
(A) Conditions.--The conditions specified
in this subparagraph are that a designated
health professions school--
(i) is a school described in
section 799B(1); and
(ii) received a contract under
section 788B for fiscal year 1987, as
such section was in effect for such
fiscal year.
(B) Use of grant.--In addition to the
purposes described in subsection (b), a grant
under subsection (a) to a designated health
professions school meeting the conditions
described in subparagraph (A) may be expended--
(i) to develop a plan to achieve
institutional improvements, including
financial independence, to enable the
school to support programs of
excellence in health professions
education for under-represented
minority individuals; and
(ii) to provide improved access to
the library and informational resources
of the school.
(C) Exception.--The requirements of
paragraph (1)(C) shall not apply to a
historically black college or university that
receives funding under paragraphs (2) or (5)
\1\.
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\1\ So in law. Probably should read ``paragraph (2) or (5)''.
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(3) Hispanic centers of excellence.--The conditions
specified in this paragraph are that--
(A) with respect to Hispanic individuals,
each of clauses (i) through (iv) of paragraph
(1)(B) applies to the designated health
professions school involved;
(B) the school agrees, as a condition of
receiving a grant under subsection (a), that
the school will, in carrying out the duties
described in subsection (b), give priority to
carrying out the duties with respect to
Hispanic individuals; and
(C) the school agrees, as a condition of
receiving a grant under subsection (a), that--
(i) the school will establish an
arrangement with 1 or more public or
nonprofit community based Hispanic
serving organizations, or public or
nonprofit private institutions of
higher education, including schools of
nursing, whose enrollment of students
has traditionally included a
significant number of Hispanic
individuals, the purposes of which will
be to carry out a program--
(I) to identify Hispanic
students who are interested in
a career in the health
profession involved; and
(II) to facilitate the
educational preparation of such
students to enter the health
professions school; and
(ii) the school will make efforts
to recruit Hispanic students, including
students who have participated in the
undergraduate or other matriculation
program carried out under arrangements
established by the school pursuant to
clause (i)(II) and will assist Hispanic
students regarding the completion of
the educational requirements for a
degree from the school.
(4) Native american centers of excellence.--Subject
to subsection (e), the conditions specified in this
paragraph are that--
(A) with respect to Native Americans, each
of clauses (i) through (iv) of paragraph (1)(B)
applies to the designated health professions
school involved;
(B) the school agrees, as a condition of
receiving a grant under subsection (a), that
the school will, in carrying out the duties
described in subsection (b), give priority to
carrying out the duties with respect to Native
Americans; and
(C) the school agrees, as a condition of
receiving a grant under subsection (a), that--
(i) the school will establish an
arrangement with 1 or more public or
nonprofit private institutions of
higher education, including schools of
nursing, whose enrollment of students
has traditionally included a
significant number of Native Americans,
the purpose of which arrangement will
be to carry out a program--
(I) to identify Native
American students, from the
institutions of higher
education referred to in clause
(i), who are interested in
health professions careers; and
(II) to facilitate the
educational preparation of such
students to enter the
designated health professions
school; and
(ii) the designated health
professions school will make efforts to
recruit Native American students,
including students who have
participated in the undergraduate
program carried out under arrangements
established by the school pursuant to
clause (i) and will assist Native
American students regarding the
completion of the educational
requirements for a degree from the
designated health professions school.
(5) Other centers of excellence.--The conditions
specified in this paragraph are--
(A) with respect to other centers of
excellence, the conditions described in clauses
(i) through (iv) of paragraph (1)(B); and
(B) that the health professions school
involved has an enrollment of under-represented
minorities above the national average for such
enrollments of health professions schools.
(d) Designation as Center of Excellence.--
(1) In general.--Any designated health professions
school receiving a grant under subsection (a) and
meeting the conditions described in paragraph (2) or
(5) of subsection (c) shall, for purposes of this
section, be designated by the Secretary as a Center of
Excellence in Under-Represented Minority Health
Professions Education.
(2) Hispanic centers of excellence.--Any designated
health professions school receiving a grant under
subsection (a) and meeting the conditions described in
subsection (c)(3) shall, for purposes of this section,
be designated by the Secretary as a Hispanic Center of
Excellence in Health Professions Education.
(3) Native american centers of excellence.--Any
designated health professions school receiving a grant
under subsection (a) and meeting the conditions
described in subsection (c)(4) shall, for purposes of
this section, be designated by the Secretary as a
Native American Center of Excellence in Health
Professions Education. Any consortium receiving such a
grant pursuant to subsection (e) shall, for purposes of
this section, be so designated.
(e) Authority Regarding Native American Centers of
Excellence.--With respect to meeting the conditions specified
in subsection (c)(4), the Secretary may make a grant under
subsection (a) to a designated health professions school that
does not meet such conditions if--
(1) the school has formed a consortium in
accordance with subsection (d)(1); and
(2) the schools of the consortium collectively meet
such conditions, without regard to whether the schools
individually meet such conditions.
(f) Duration of Grant.--The period during which payments
are made under a grant under subsection (a) may not exceed 5
years. Such payments shall be subject to annual approval by the
Secretary and to the availability of appropriations for the
fiscal year involved to make the payments.
(g) Definitions.--In this section:
(1) Designated health professions school.--
(A) In general.--The term ``health
professions school'' means, except as provided
in subparagraph (B), a school of medicine, a
school of osteopathic medicine, a school of
dentistry, a school of pharmacy, or a graduate
program in behavioral or mental health.
(B) Exception.--The definition established
in subparagraph (A) shall not apply to the use
of the term ``designated health professions
school'' for purposes of subsection (c)(2).
(2) Program of excellence.--The term ``program of
excellence'' means any program carried out by a
designated health professions school with a grant made
under subsection (a), if the program is for purposes
for which the school involved is authorized in
subsection (b) or (c) to expend the grant.
(3) Native americans.--The term ``Native
Americans'' means American Indians, Alaskan Natives,
Aleuts, and Native Hawaiians.
(h) Formula for Allocations.--
(1) Allocations.--Based on the amount appropriated
under subsection (i) for a fiscal year, the following
subparagraphs shall apply as appropriate:
(A) In general.--If the amounts
appropriated under subsection (i) for a fiscal
year are $24,000,000 or less--
(i) the Secretary shall make
available $12,000,000 for grants under
subsection (a) to health professions
schools that meet the conditions
described in subsection (c)(2)(A); and
(ii) and available after grants are
made with funds under clause (i), the
Secretary shall make available--
(I) 60 percent of such
amount for grants under
subsection (a) to health
professions schools that meet
the conditions described in
paragraph (3) or (4) of
subsection (c) (including
meeting the conditions under
subsection (e)); and
(II) 40 percent of such
amount for grants under
subsection (a) to health
professions schools that meet
the conditions described in
subsection (c)(5).
(B) Funding in excess of $24,000,000.--If
amounts appropriated under subsection (i) for a
fiscal year exceed $24,000,000 but are less
than $30,000,000--
(i) 80 percent of such excess
amounts shall be made available for
grants under subsection (a) to health
professions schools that meet the
requirements described in paragraph (3)
or (4) of subsection (c) (including
meeting conditions pursuant to
subsection (e)); and
(ii) 20 percent of such excess
amount shall be made available for
grants under subsection (a) to health
professions schools that meet the
conditions described in subsection
(c)(5).
(C) Funding in excess of $30,000,000.--If
amounts appropriated under subsection (i) for a
fiscal year exceed $30,000,000 but are less
than $40,000,000, the Secretary shall make
available--
(i) not less than $12,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in subsection
(c)(2)(A);
(ii) not less than $12,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in paragraph (3)
or (4) of subsection (c) (including
meeting conditions pursuant to
subsection (e));
(iii) not less than $6,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in subsection
(c)(5); and
(iv) after grants are made with
funds under clauses (i) through (iii),
any remaining excess amount for grants
under subsection (a) to health
professions schools that meet the
conditions described in paragraph
(2)(A), (3), (4), or (5) of subsection
(c).
(D) Funding in excess of $40,000,000.--If
amounts appropriated under subsection (i) for a
fiscal year are $40,000,000 or more, the
Secretary shall make available--
(i) not less than $16,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in subsection
(c)(2)(A);
(ii) not less than $16,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in paragraph (3)
or (4) of subsection (c) (including
meeting conditions pursuant to
subsection (e));
(iii) not less than $8,000,000 for
grants under subsection (a) to health
professions schools that meet the
conditions described in subsection
(c)(5); and
(iv) after grants are made with
funds under clauses (i) through (iii),
any remaining funds for grants under
subsection (a) to health professions
schools that meet the conditions
described in paragraph (2)(A), (3),
(4), or (5) of subsection (c).
(2) No limitation.--Nothing in this subsection
shall be construed as limiting the centers of
excellence referred to in this section to the
designated amount, or to preclude such entities from
competing for grants under this section.
(3) Maintenance of effort.--
(A) In general.--With respect to activities
for which a grant made under this part are
authorized to be expended, the Secretary may
not make such a grant to a center of excellence
for any fiscal year unless the center agrees to
maintain expenditures of non-Federal amounts
for such activities at a level that is not less
than the level of such expenditures maintained
by the center for the fiscal year preceding the
fiscal year for which the school receives such
a grant.
(B) Use of federal funds.--With respect to
any Federal amounts received by a center of
excellence and available for carrying out
activities for which a grant under this part is
authorized to be expended, the center shall,
before expending the grant, expend the Federal
amounts obtained from sources other than the
grant, unless given prior approval from the
Secretary.
(i) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section--
(1) $50,000,000 for each of the fiscal years 2010
through 2015; and
(2) and such sums as are necessary for each
subsequent fiscal year.
SEC. 737. [293A] SCHOLARSHIPS FOR DISADVANTAGED STUDENTS.
(a) In General.--The Secretary may make a grant to an
eligible entity (as defined in subsection (d)(1)) under this
section for the awarding of scholarships by schools to any
full-time student who is an eligible individual as defined in
subsection (d). Such scholarships may be expended only for
tuition expenses, other reasonable educational expenses, and
reasonable living expenses incurred in the attendance of such
school.
(b) Preference in Providing Scholarships.--The Secretary
may not make a grant to an entity under subsection (a) unless
the health professions and nursing schools involved agree that,
in providing scholarships pursuant to the grant, the schools
will give preference to students for whom the costs of
attending the schools would constitute a severe financial
hardship and, notwithstanding other provisions of this section,
to former recipients of scholarships under sections 736 and
740(d)(2)(B) (as such sections existed on the day before the
date of enactment of this section).
(c) Amount of Award.--In awarding grants to eligible
entities that are health professions and nursing schools, the
Secretary shall give priority to eligible entities based on the
proportion of graduating students going into primary care, the
proportion of underrepresented minority students, and the
proportion of graduates working in medically underserved
communities.
(d) Definitions.--In this section:
(1) Eligible entities.--The term ``eligible
entities'' means an entity that--
(A) is a school of medicine, osteopathic
medicine, dentistry, nursing (as defined in
section 801), pharmacy, podiatric medicine,
optometry, veterinary medicine, public health,
chiropractic, or allied health, a school
offering a graduate program in behavioral and
mental health practice, or an entity providing
programs for the training of physician
assistants; and
(B) is carrying out a program for
recruiting and retaining students from
disadvantaged backgrounds, including students
who are members of racial and ethnic minority
groups.
(2) Eligible individual.--The term ``eligible
individual'' means an individual who--
(A) is from a disadvantaged background;
(B) has a financial need for a scholarship;
and
(C) is enrolled (or accepted for
enrollment) at an eligible health professions
or nursing school as a full-time student in a
program leading to a degree in a health
profession or nursing.
SEC. 738. [293B] LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY
POSITIONS.
(a) Loan Repayments.--
(1) Establishment of program.--The Secretary shall
establish a program of entering into contracts with
individuals described in paragraph (2) under which the
individuals agree to serve as members of the faculties
of schools described in paragraph (3) in consideration
of the Federal Government agreeing to pay, for each
year of such service, not more than $30,000 of the
principal and interest of the educational loans of such
individuals.
(2) Eligible individuals.--The individuals referred
to in paragraph (1) are individuals from disadvantaged
backgrounds who--
(A) have a degree in medicine, osteopathic
medicine, dentistry, nursing, or another health
profession;
(B) are enrolled in an approved graduate
training program in medicine, osteopathic
medicine, dentistry, nursing, or other health
profession; or
(C) are enrolled as full-time students--
(i) in an accredited (as determined
by the Secretary) school described in
paragraph (3); and
(ii) in the final year of a course
of a study or program, offered by such
institution and approved by the
Secretary, leading to a degree from
such a school.
(3) Eligible health professions schools.--The
schools described in this paragraph are schools of
medicine, nursing (as schools of nursing are defined in
section 801), osteopathic medicine, dentistry,
pharmacy, allied health, podiatric medicine, optometry,
veterinary medicine, or public health, schools offering
physician assistant education programs, or schools
offering graduate programs in behavioral and mental
health.
(4) Requirements regarding faculty positions.--The
Secretary may not enter into a contract under paragraph
(1) unless--
(A) the individual involved has entered
into a contract with a school described in
paragraph (3) to serve as a member of the
faculty of the school for not less than 2
years; and
(B) the contract referred to in
subparagraph (A) provides that--
(i) the school will, for each year
for which the individual will serve as
a member of the faculty under the
contract with the school, make payments
of the principal and interest due on
the educational loans of the individual
for such year in an amount equal to the
amount of such payments made by the
Secretary for the year;
(ii) the payments made by the
school pursuant to clause (i) on behalf
of the individual will be in addition
to the pay that the individual would
otherwise receive for serving as a
member of such faculty; and
(iii) the school, in making a
determination of the amount of
compensation to be provided by the
school to the individual for serving as
a member of the faculty, will make the
determination without regard to the
amount of payments made (or to be made)
to the individual by the Federal
Government under paragraph (1).
(5) Applicability of certain provisions.--The
provisions of sections 338C, 338G, and 338I shall apply
to the program established in paragraph (1) to the same
extent and in the same manner as such provisions apply
to the National Health Service Corps Loan Repayment
Program established in subpart III of part D of title
III, including the applicability of provisions
regarding reimbursements for increased tax liability
and regarding bankruptcy.
(6) Waiver regarding school contributions.--The
Secretary may waive the requirement established in
paragraph (4)(B) if the Secretary determines that the
requirement will impose an undue financial hardship on
the school involved.
(b) Fellowships.--
(1) In general.--The Secretary may make grants to
and enter into contracts with eligible entities to
assist such entities in increasing the number of
underrepresented minority individuals who are members
of the faculty of such schools.
(2) Applications.--To be eligible to receive a
grant or contract under this subsection, an entity
shall provide an assurance, in the application
submitted by the entity, that--
(A) amounts received under such a grant or
contract will be used to award a fellowship to
an individual only if the individual meets the
requirements of paragraphs (3) and (4); and
(B) each fellowship awarded pursuant to the
grant or contract will include--
(i) a stipend in an amount not
exceeding 50 percent of the regular
salary of a similar faculty member for
not to exceed 3 years of training; and
(ii) an allowance for other
expenses, such as travel to
professional meetings and costs related
to specialized training.
(3) Eligibility.--To be eligible to receive a grant
or contract under paragraph (1), an applicant shall
demonstrate to the Secretary that such applicant has or
will have the ability to--
(A) identify, recruit and select
underrepresented minority individuals who have
the potential for teaching, administration, or
conducting research at a health professions
institution;
(B) provide such individuals with the
skills necessary to enable them to secure a
tenured faculty position at such institution,
which may include training with respect to
pedagogical skills, program administration, the
design and conduct of research, grants writing,
and the preparation of articles suitable for
publication in peer reviewed journals;
(C) provide services designed to assist
such individuals in their preparation for an
academic career, including the provision of
counselors; and
(D) provide health services to rural or
medically underserved populations.
(4) Requirements.--To be eligible to receive a
grant or contract under paragraph (1) an applicant
shall--
(A) provide an assurance that such
applicant will make available (directly through
cash donations) $1 for every $1 of Federal
funds received under this section for the
fellowship;
(B) provide an assurance that institutional
support will be provided for the individual for
the second and third years at a level that is
equal to the total amount of institutional
funds provided in the year in which the grant
or contract was awarded;
(C) provide an assurance that the
individual that will receive the fellowship
will be a member of the faculty of the
applicant school; and
(D) provide an assurance that the
individual that will receive the fellowship
will have, at a minimum, appropriate advanced
preparation (such as a master's or doctoral
degree) and special skills necessary to enable
such individual to teach and practice.
(5) Definition.--For purposes of this subsection,
the term ``underrepresented minority individuals''
means individuals who are members of racial or ethnic
minority groups that are underrepresented in the health
professions including nursing.
SEC. 739. [293C] EDUCATIONAL ASSISTANCE IN THE HEALTH PROFESSIONS
REGARDING INDIVIDUALS FROM DISADVANTAGED
BACKGROUNDS.
(a) In General.--
(1) Authority for grants.--For the purpose of
assisting individuals from disadvantaged backgrounds,
as determined in accordance with criteria prescribed by
the Secretary, to undertake education to enter a health
profession, the Secretary may make grants to and enter
into contracts with schools of medicine, osteopathic
medicine, public health, dentistry, veterinary
medicine, optometry, pharmacy, allied health,
chiropractic, and podiatric medicine, public and
nonprofit private schools that offer graduate programs
in behavioral and mental health, programs for the
training of physician assistants, and other public or
private nonprofit health or educational entities to
assist in meeting the costs described in paragraph (2).
(2) Authorized expenditures.--A grant or contract
under paragraph (1) may be used by the entity to meet
the cost of--
(A) identifying, recruiting, and selecting
individuals from disadvantaged backgrounds, as
so determined, for education and training in a
health profession;
(B) facilitating the entry of such
individuals into such a school;
(C) providing counseling, mentoring, or
other services designed to assist such
individuals to complete successfully their
education at such a school;
(D) providing, for a period prior to the
entry of such individuals into the regular
course of education of such a school,
preliminary education and health research
training designed to assist them to complete
successfully such regular course of education
at such a school, or referring such individuals
to institutions providing such preliminary
education;
(E) publicizing existing sources of
financial aid available to students in the
education program of such a school or who are
undertaking training necessary to qualify them
to enroll in such a program;
(F) paying such scholarships as the
Secretary may determine for such individuals
for any period of health professions education
at a health professions school;
(G) paying such stipends as the Secretary
may approve for such individuals for any period
of education in student-enhancement programs
(other than regular courses), except that such
a stipend may not be provided to an individual
for more than 12 months, and such a stipend
shall be in an amount determined appropriate by
the Secretary (notwithstanding any other
provision of law regarding the amount of
stipends);
(H) carrying out programs under which such
individuals gain experience regarding a career
in a field of primary health care through
working at facilities of public or private
nonprofit community-based providers of primary
health services; and
(I) conducting activities to develop a
larger and more competitive applicant pool
through partnerships with institutions of
higher education, school districts, and other
community-based entities.
(3) Definition.--In this section, the term
``regular course of education of such a school'' as
used in subparagraph (D) includes a graduate program in
behavioral or mental health.
(b) Requirements for Awards.--In making awards to eligible
entities under subsection (a)(1), the Secretary shall give
preference to approved applications for programs that involve a
comprehensive approach by several public or nonprofit private
health or educational entities to establish, enhance and expand
educational programs that will result in the development of a
competitive applicant pool of individuals from disadvantaged
backgrounds who desire to pursue health professions careers. In
considering awards for such a comprehensive partnership
approach, the following shall apply with respect to the entity
involved:
(1) The entity shall have a demonstrated commitment
to such approach through formal agreements that have
common objectives with institutions of higher
education, school districts, and other community-based
entities.
(2) Such formal agreements shall reflect the
coordination of educational activities and support
services, increased linkages, and the consolidation of
resources within a specific geographic area.
(3) The design of the educational activities
involved shall provide for the establishment of a
competitive health professions applicant pool of
individuals from disadvantaged backgrounds by enhancing
the total preparation (academic and social) of such
individuals to pursue a health professions career.
(4) The programs or activities under the award
shall focus on developing a culturally competent health
care workforce that will serve the unserved and
underserved populations within the geographic area.
(c) Equitable Allocation of Financial Assistance.--The
Secretary, to the extent practicable, shall ensure that
services and activities under subsection (a) are adequately
allocated among the various racial and ethnic populations who
are from disadvantaged backgrounds.
(d) Matching Requirements.--The Secretary may require that
an entity that applies for a grant or contract under subsection
(a), provide non-Federal matching funds, as appropriate, to
ensure the institutional commitment of the entity to the
projects funded under the grant or contract. As determined by
the Secretary, such non-Federal matching funds may be provided
directly or through donations from public or private entities
and may be in cash or in-kind, fairly evaluated, including
plant, equipment, or services.
SEC. 740. [293D] AUTHORIZATION OF APPROPRIATION.
(a) Scholarships.--There are authorized to be appropriated
to carry out section 737, $51,000,000 for fiscal year 2010, and
such sums as may be necessary for each of the fiscal years 2011
through 2014. Of the amount appropriated in any fiscal year,
the Secretary shall ensure that not less than 16 percent shall
be distributed to schools of nursing.
(b) Loan Repayments and Fellowships.--For the purpose of
carrying out section 738, there is authorized to be
appropriated, $5,000,000 for each of the fiscal years 2010
through 2014.
(c) Educational Assistance in Health Professions Regarding
Individuals for Disadvantaged Backgrounds.--For the purpose of
grants and contracts under section 739(a)(1), there is
authorized to be appropriated $60,000,000 for fiscal year 2010
and such sums as may be necessary for each of the fiscal years
2011 through 2014. The Secretary may use not to exceed 20
percent of the amount appropriated for a fiscal year under this
subsection to provide scholarships under section 739(a)(2)(F).
(d) Report.--Not later than 6 months after the date of
enactment of this part, the Secretary shall prepare and submit
to the appropriate committees of Congress a report concerning
the efforts of the Secretary to address the need for a
representative mix of individuals from historically minority
health professions schools, or from institutions or other
entities that historically or by geographic location have a
demonstrated record of training or educating underrepresented
minorities, within various health professions disciplines, on
peer review councils.
SEC. 741. [293E] GRANTS FOR HEALTH PROFESSIONS EDUCATION.
(a) Cultural Competency, Prevention, and Public Health and
Individuals With Disability Grants.--
(1) In general.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make awards of grants, contracts,
or cooperative agreements to public and nonprofit
private entities (including tribal entities) for the
development, evaluation, and dissemination of research,
demonstration projects, and model curricula for
cultural competency, prevention, public health
proficiency, reducing health disparities, and aptitude
for working with individuals with disabilities training
for use in health professions schools and continuing
education programs, and for other purposes determined
as appropriate by the Secretary.
(2) Eligible entities.--Unless specifically
required otherwise in this title, the Secretary shall
accept applications for grants or contracts under this
section from health professions schools, academic
health centers, State or local governments, or other
appropriate public or private nonprofit entities (or
consortia of entities, including entities promoting
multidisciplinary approaches) for funding and
participation in health professions training
activities. The Secretary may accept applications from
for-profit private entities as determined appropriate
by the Secretary.
(b) Collaboration.--In carrying out subsection (a), the
Secretary shall collaborate with health professional societies,
licensing and accreditation entities, health professions
schools, and experts in minority health and cultural
competency, prevention, and public health and disability
groups, community-based organizations, and other organizations
as determined appropriate by the Secretary. The Secretary shall
coordinate with curricula and research and demonstration
projects developed under section 807.
(c) Dissemination.--
(1) In general.--Model curricula developed under
this section shall be disseminated through the Internet
Clearinghouse under section 270 and such other means as
determined appropriate by the Secretary.
(2) Evaluation.--The Secretary shall evaluate the
adoption and the implementation of cultural competency,
prevention, and public health, and working with
individuals with a disability training curricula, and
the facilitate inclusion of these competency measures
in quality measurement systems as appropriate.
(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2015.
PART C--TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL
PEDIATRICS, PHYSICIAN ASSISTANTS, GENERAL DENTISTRY, AND PEDIATRIC
DENTISTRY
Subpart I--Medical Training Generally
SEC. 747. [293K] PRIMARY CARE TRAINING AND ENHANCEMENT.
(a) Support and Development of Primary Care Training
Programs.--
(1) In general.--The Secretary may make grants to,
or enter into contracts with, an accredited public or
nonprofit private hospital, school of medicine or
osteopathic medicine, academically affiliated physician
assistant training program, or a public or private
nonprofit entity which the Secretary has determined is
capable of carrying out such grant or contract--
(A) to plan, develop, operate, or
participate in an accredited professional
training program, including an accredited
residency or internship program in the field of
family medicine, general internal medicine, or
general pediatrics for medical students,
interns, residents, or practicing physicians as
defined by the Secretary;
(B) to provide need-based financial
assistance in the form of traineeships and
fellowships to medical students, interns,
residents, practicing physicians, or other
medical personnel, who are participants in any
such program, and who plan to specialize or
work in the practice of the fields defined in
subparagraph (A);
(C) to plan, develop, and operate a program
for the training of physicians who plan to
teach in family medicine, general internal
medicine, or general pediatrics training
programs;
(D) to plan, develop, and operate a program
for the training of physicians teaching in
community-based settings;
(E) to provide financial assistance in the
form of traineeships and fellowships to
physicians who are participants in any such
programs and who plan to teach or conduct
research in a family medicine, general internal
medicine, or general pediatrics training
program;
(F) to plan, develop, and operate a
physician assistant education program, and for
the training of individuals who will teach in
programs to provide such training;
(G) to plan, develop, and operate a
demonstration program that provides training in
new competencies, as recommended by the
Advisory Committee on Training in Primary Care
Medicine and Dentistry and the National Health
Care Workforce Commission established in
section 5101 of the Patient Protection and
Affordable Care Act, which may include--
(i) providing training to primary
care physicians relevant to providing
care through patient-centered medical
homes (as defined by the Secretary for
purposes of this section);
(ii) developing tools and curricula
relevant to patient-centered medical
homes; and
(iii) providing continuing
education to primary care physicians
relevant to patient-centered medical
homes; and
(H) to plan, develop, and operate joint
degree programs to provide interdisciplinary
and interprofessional graduate training in
public health and other health professions to
provide training in environmental health,
infectious disease control, disease prevention
and health promotion, epidemiological studies
and injury control.
(2) Duration of awards.--The period during which
payments are made to an entity from an award of a grant
or contract under this subsection shall be 5 years.
(b) Capacity Building in Primary Care.--
(1) In general.--The Secretary may make grants to
or enter into contracts with accredited schools of
medicine or osteopathic medicine to establish,
maintain, or improve--
(A) academic units or programs that improve
clinical teaching and research in fields
defined in subsection (a)(1)(A); or
(B) programs that integrate academic
administrative units in fields defined in
subsection (a)(1)(A) to enhance
interdisciplinary recruitment, training, and
faculty development.
(2) Preference in making awards under this
subsection.--In making awards of grants and contracts
under paragraph (1), the Secretary shall give
preference to any qualified applicant for such an award
that agrees to expend the award for the purpose of--
(A) establishing academic units or programs
in fields defined in subsection (a)(1)(A); or
(B) substantially expanding such units or
programs.
(3) Priorities in making awards.--In awarding
grants or contracts under paragraph (1), the Secretary
shall give priority to qualified applicants that--
(A) proposes a collaborative project
between academic administrative units of
primary care;
(B) proposes innovative approaches to
clinical teaching using models of primary care,
such as the patient centered medical home, team
management of chronic disease, and
interprofessional integrated models of health
care that incorporate transitions in health
care settings and integration physical and
mental health provision;
(C) have a record of training the greatest
percentage of providers, or that have
demonstrated significant improvements in the
percentage of providers trained, who enter and
remain in primary care practice;
(D) have a record of training individuals
who are from underrepresented minority groups
or from a rural or disadvantaged background;
(E) provide training in the care of
vulnerable populations such as children, older
adults, homeless individuals, victims of abuse
or trauma, individuals with mental health or
substance-related disorders, individuals with
HIV/AIDS, and individuals with disabilities;
(F) establish formal relationships and
submit joint applications with federally
qualified health centers, rural health clinics,
area health education centers, or clinics
located in underserved areas or that serve
underserved populations;
(G) teach trainees the skills to provide
interprofessional, integrated care through
collaboration among health professionals;
(H) provide training in enhanced
communication with patients, evidence-based
practice, chronic disease management,
preventive care, health information technology,
or other competencies as recommended by the
Advisory Committee on Training in Primary Care
Medicine and Dentistry and the National Health
Care Workforce Commission established in
section 5101 of the Patient Protection and
Affordable Care Act; or
(I) provide training in cultural competency
and health literacy.
(4) Duration of awards.--The period during which
payments are made to an entity from an award of a grant
or contract under this subsection shall be 5 years.
(c) Authorization of Appropriations.--
(1) In general.--For purposes of carrying out this
section (other than subsection (b)(1)(B)), there are
authorized to be appropriated $125,000,000 for fiscal
year 2010, and such sums as may be necessary for each
of fiscal years 2011 through 2014.
(2) Training programs.--Fifteen percent of the
amount appropriated pursuant to paragraph (1) in each
such fiscal year shall be allocated to the physician
assistant training programs described in subsection
(a)(1)(F), which prepare students for practice in
primary care.
(3) Integrating academic administrative units.--For
purposes of carrying out subsection (b)(1)(B), there
are authorized to be appropriated $750,000 for each of
fiscal years 2010 through 2014.
SEC. 747A. [293K-1] TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.
(a) In General.--The Secretary shall award grants to
eligible entities to enable such entities to provide new
training opportunities for direct care workers who are employed
in long-term care settings such as nursing homes (as defined in
section 1908(e)(1) of the Social Security Act (42 U.S.C.
1396g(e)(1)), assisted living facilities and skilled nursing
facilities, intermediate care facilities for individuals with
mental retardation, home and community based settings, and any
other setting the Secretary determines to be appropriate.
(b) Eligibility.--To be eligible to receive a grant under
this section, an entity shall--
(1) be an institution of higher education (as
defined in section 102 of the Higher Education Act of
1965 (20 U.S.C. 1002)) that--
(A) is accredited by a nationally
recognized accrediting agency or association
listed under section 101(c) of the Higher
Education Act of 1965 (20 U.S.C. 1001(c)); and
(B) has established a public-private
educational partnership with a nursing home or
skilled nursing facility, agency or entity
providing home and community based services to
individuals with disabilities, or other long-
term care provider; and
(2) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require.
(c) Use of Funds.--An eligible entity shall use amounts
awarded under a grant under this section to provide assistance
to eligible individuals to offset the cost of tuition and
required fees for enrollment in academic programs provided by
such entity.
(d) Eligible Individual.--
(1) Eligibility.--To be eligible for assistance
under this section, an individual shall be enrolled in
courses provided by a grantee under this subsection and
maintain satisfactory academic progress in such
courses.
(2) Condition of assistance.--As a condition of
receiving assistance under this section, an individual
shall agree that, following completion of the
assistance period, the individual will work in the
field of geriatrics, disability services, long term
services and supports, or chronic care management for a
minimum of 2 years under guidelines set by the
Secretary.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $10,000,000 for
the period of fiscal years 2011 through 2013.
SEC. 748. [293K-2] TRAINING IN GENERAL, PEDIATRIC, AND PUBLIC HEALTH
DENTISTRY.
(a) Support and Development of Dental Training Programs.--
(1) In general.--The Secretary may make grants to,
or enter into contracts with, a school of dentistry,
public or nonprofit private hospital, or a public or
private nonprofit entity which the Secretary has
determined is capable of carrying out such grant or
contract--
(A) to plan, develop, and operate, or
participate in, an approved professional
training program in the field of general
dentistry, pediatric dentistry, or public
health dentistry for dental students,
residents, practicing dentists, dental
hygienists, or other approved primary care
dental trainees, that emphasizes training for
general, pediatric, or public health dentistry;
(B) to provide financial assistance to
dental students, residents, practicing
dentists, and dental hygiene students who are
in need thereof, who are participants in any
such program, and who plan to work in the
practice of general, pediatric, public heath
dentistry, or dental hygiene;
(C) to plan, develop, and operate a program
for the training of oral health care providers
who plan to teach in general, pediatric, public
health dentistry, or dental hygiene;
(D) to provide financial assistance in the
form of traineeships and fellowships to
dentists who plan to teach or are teaching in
general, pediatric, or public health dentistry;
(E) to meet the costs of projects to
establish, maintain, or improve dental faculty
development programs in primary care (which may
be departments, divisions or other units);
(F) to meet the costs of projects to
establish, maintain, or improve predoctoral and
postdoctoral training in primary care programs;
(G) to create a loan repayment program for
faculty in dental programs; and
(H) to provide technical assistance to
pediatric training programs in developing and
implementing instruction regarding the oral
health status, dental care needs, and risk-
based clinical disease management of all
pediatric populations with an emphasis on
underserved children.
(2) Faculty loan repayment.--
(A) In general.--A grant or contract under
subsection (a)(1)(G) may be awarded to a
program of general, pediatric, or public health
dentistry described in such subsection to plan,
develop, and operate a loan repayment program
under which--
(i) individuals agree to serve
full-time as faculty members; and
(ii) the program of general,
pediatric or public health dentistry
agrees to pay the principal and
interest on the outstanding student
loans of the individuals.
(B) Manner of payments.--With respect to
the payments described in subparagraph (A)(ii),
upon completion by an individual of each of the
first, second, third, fourth, and fifth years
of service, the program shall pay an amount
equal to 10, 15, 20, 25, and 30 percent,
respectively, of the individual's student loan
balance as calculated based on principal and
interest owed at the initiation of the
agreement.
(b) Eligible Entity.--For purposes of this subsection,
entities eligible for such grants or contracts in general,
pediatric, or public health dentistry shall include entities
that have programs in dental or dental hygiene schools, or
approved residency or advanced education programs in the
practice of general, pediatric, or public health dentistry.
Eligible entities may partner with schools of public health to
permit the education of dental students, residents, and dental
hygiene students for a master's year in public health at a
school of public health.
(c) Priorities in Making Awards.--With respect to training
provided for under this section, the Secretary shall give
priority in awarding grants or contracts to the following:
(1) Qualified applicants that propose collaborative
projects between departments of primary care medicine
and departments of general, pediatric, or public health
dentistry.
(2) Qualified applicants that have a record of
training the greatest percentage of providers, or that
have demonstrated significant improvements in the
percentage of providers, who enter and remain in
general, pediatric, or public health dentistry.
(3) Qualified applicants that have a record of
training individuals who are from a rural or
disadvantaged background, or from underrepresented
minorities.
(4) Qualified applicants that establish formal
relationships with Federally qualified health centers,
rural health centers, or accredited teaching facilities
and that conduct training of students, residents,
fellows, or faculty at the center or facility.
(5) Qualified applicants that conduct teaching
programs targeting vulnerable populations such as older
adults, homeless individuals, victims of abuse or
trauma, individuals with mental health or substance-
related disorders, individuals with disabilities, and
individuals with HIV/AIDS, and in the risk-based
clinical disease management of all populations.
(6) Qualified applicants that include educational
activities in cultural competency and health literacy.
(7) Qualified applicants that have a high rate for
placing graduates in practice settings that serve
underserved areas or health disparity populations, or
who achieve a significant increase in the rate of
placing graduates in such settings.
(8) Qualified applicants that intend to establish a
special populations oral health care education center
or training program for the didactic and clinical
education of dentists, dental health professionals, and
dental hygienists who plan to teach oral health care
for people with developmental disabilities, cognitive
impairment, complex medical problems, significant
physical limitations, and vulnerable elderly.
(d) Application.--An eligible entity desiring a grant under
this section shall submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
(e) Duration of Award.--The period during which payments
are made to an entity from an award of a grant or contract
under subsection (a) shall be 5 years. The provision of such
payments shall be subject to annual approval by the Secretary
and subject to the availability of appropriations for the
fiscal year involved to make the payments.
(f) Authorizations of Appropriations.--For the purpose of
carrying out subsections (a) and (b), there is authorized to be
appropriated $30,000,000 for fiscal year 2010 and such sums as
may be necessary for each of fiscal years 2011 through 2015.
(g) Carryover Funds.--An entity that receives an award
under this section may carry over funds from 1 fiscal year to
another without obtaining approval from the Secretary. In no
case may any funds be carried over pursuant to the preceding
sentence for more than 3 years.
SEC. 749. [293L] ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE
MEDICINE AND DENTISTRY.
(a) Establishment.--The Secretary shall establish an
advisory committee to be known as the Advisory Committee on
Training in Primary Care Medicine and Dentistry (in this
section referred to as the ``Advisory Committee'').
(b) Composition.--
(1) In general.--The Secretary shall determine the
appropriate number of individuals to serve on the
Advisory Committee. Such individuals shall not be
officers or employees of the Federal Government.
(2) Appointment.--Not later than 90 days after the
date of enactment of this Act \1\, the Secretary shall
appoint the members of the Advisory Committee from
among individuals who are health professionals. In
making such appointments, the Secretary shall ensure a
fair balance between the health professions, that at
least 75 percent of the members of the Advisory
Committee are health professionals, a broad geographic
representation of members and a balance between urban
and rural members. Members shall be appointed based on
their competence, interest, and knowledge of the
mission of the profession involved.
---------------------------------------------------------------------------
\1\ So in law. The reference to ``this Act'' means the Public
Health Service Act, which was enacted July 1, 1944. Probably should be
a reference to the Health Professions Education Partnerships Act of
1998, which added section 748. That Act is Public Law 105-392, enacted
November 13, 1998. (Section 102(4) of that Public Law (112 Stat. 3539)
added section 748.)
---------------------------------------------------------------------------
(3) Minority representation.--In appointing the
members of the Advisory Committee under paragraph (2),
the Secretary shall ensure the adequate representation
of women and minorities.
(c) Terms.--
(1) In general.--A member of the Advisory Committee
shall be appointed for a term of 3 years, except that
of the members first appointed--
(A) \1/3\ of such members shall serve for a
term of 1 year;
(B) \1/3\ of such members shall serve for a
term of 2 years; and
(C) \1/3\ of such members shall serve for a
term of 3 years.
(2) Vacancies.--
(A) In general.--A vacancy on the Advisory
Committee shall be filled in the manner in
which the original appointment was made and
shall be subject to any conditions which
applied with respect to the original
appointment.
(B) Filling unexpired term.--An individual
chosen to fill a vacancy shall be appointed for
the unexpired term of the member replaced.
(d) Duties.--The Advisory Committee shall--
(1) provide advice and recommendations to the
Secretary concerning policy and program development and
other matters of significance concerning the activities
under section 747;
(2) not later than 3 years after the date of
enactment of this section, and annually thereafter,
prepare and submit to the Secretary, and the Committee
on Labor and Human Resources of the Senate, and the
Committee on Commerce of the House of Representatives,
a report describing the activities of the Committee,
including findings and recommendations made by the
Committee concerning the activities under section 747;
(3) develop, publish, and implement performance
measures for programs under this part;
(4) develop and publish guidelines for longitudinal
evaluations (as described in section 761(d)(2)) for
programs under this part; and
(5) recommend appropriation levels for programs
under this part.
(e) Meetings and Documents.--
(1) Meetings.--The Advisory Committee shall meet
not less than 2 times each year. Such meetings shall be
held jointly with other related entities established
under this title where appropriate.
(2) Documents.--Not later than 14 days prior to the
convening of a meeting under paragraph (1), the
Advisory Committee shall prepare and make available an
agenda of the matters to be considered by the Advisory
Committee at such meeting. At any such meeting, the
Advisory Council \1\ shall distribute materials with
respect to the issues to be addressed at the meeting.
Not later than 30 days after the adjourning of such a
meeting, the Advisory Committee shall prepare and make
available a summary of the meeting and any actions
taken by the Committee based upon the meeting.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``Advisory Committee''. See
section 102(4) of Public Law 105-392 (112 Stat. 3539).
---------------------------------------------------------------------------
(f) Compensation and Expenses.--
(1) Compensation.--Each member of the Advisory
Committee shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic pay
prescribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each
day (including travel time) during which such member is
engaged in the performance of the duties of the
Committee.
(2) Expenses.--The members of the Advisory
Committee shall be allowed travel expenses, including
per diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I of chapter
57 of title 5, United States Code, while away from
their homes or regular places of business in the
performance of services for the Committee.
(g) FACA.--The Federal Advisory Committee Act shall apply
to the Advisory Committee under this section only to the extent
that the provisions of such Act do not conflict with the
requirements of this section.
SEC. 749A. [293L-1] TEACHING HEALTH CENTERS DEVELOPMENT GRANTS.
(a) Program Authorized.--The Secretary may award grants
under this section to teaching health centers for the purpose
of establishing new accredited or expanded primary care
residency programs.
(b) Amount and Duration.--Grants awarded under this section
shall be for a term of not more than 3 years and the maximum
award may not be more than $500,000.
(c) Use of Funds.--Amounts provided under a grant under
this section shall be used to cover the costs of--
(1) establishing or expanding a primary care
residency training program described in subsection (a),
including costs associated with--
(A) curriculum development;
(B) recruitment, training and retention of
residents and faculty:
(C) accreditation by the Accreditation
Council for Graduate Medical Education (ACGME),
the American Dental Association (ADA), or the
American Osteopathic Association (AOA); and
(D) faculty salaries during the development
phase; and
(2) technical assistance provided by an eligible
entity.
(d) Application.--A teaching health center seeking a grant
under this section shall submit an application to the Secretary
at such time, in such manner, and containing such information
as the Secretary may require.
(e) Preference for Certain Applications.--In selecting
recipients for grants under this section, the Secretary shall
give preference to any such application that documents an
existing affiliation agreement with an area health education
center program as defined in sections 751 and 799B.
(f) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity''
means an organization capable of providing technical
assistance including an area health education center
program as defined in sections 751 and 799B.
(2) Primary care residency program.--The term
``primary care residency program'' means an approved
graduate medical residency training program (as defined
in section 340H) in family medicine, internal medicine,
pediatrics, internal medicine-pediatrics, obstetrics
and gynecology, psychiatry, general dentistry,
pediatric dentistry, and geriatrics.
(3) Teaching health center.--
(A) In general.--The term ``teaching health
center'' means an entity that--
(i) is a community based,
ambulatory patient care center; and
(ii) operates a primary care
residency program.
(B) Inclusion of certain entities.--Such
term includes the following:
(i) A Federally qualified health
center (as defined in section
1905(l)(2)(B), of the Social Security
Act).
(ii) A community mental health
center (as defined in section
1861(ff)(3)(B) of the Social Security
Act).
(iii) A rural health clinic, as
defined in section 1861(aa) of the
Social Security Act.
(iv) A health center operated by
the Indian Health Service, an Indian
tribe or tribal organization, or an
urban Indian organization (as defined
in section 4 of the Indian Health Care
Improvement Act).
(v) An entity receiving funds under
title X of the Public Health Service
Act.
(g) Authorization of Appropriations.--There is authorized
to be appropriated, $25,000,000 for fiscal year 2010,
$50,000,000 for fiscal year 2011, $50,000,000 for fiscal year
2012, and such sums as may be necessary for each fiscal year
thereafter to carry out this section. Not to exceed $5,000,000
annually may be used for technical assistance program grants.
Subpart II--Training in Underserved Communities
SEC. 749B. [293M] RURAL PHYSICIAN TRAINING GRANTS.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall establish a grant program for the
purposes of assisting eligible entities in recruiting students
most likely to practice medicine in underserved rural
communities, providing rural-focused training and experience,
and increasing the number of recent allopathic and osteopathic
medical school graduates who practice in underserved rural
communities.
(b) Eligible Entities.--In order to be eligible to receive
a grant under this section, an entity shall--
(1) be a school of allopathic or osteopathic
medicine accredited by a nationally recognized
accrediting agency or association approved by the
Secretary for this purpose, or any combination or
consortium of such schools; and
(2) submit an application to the Secretary that
includes a certification that such entity will use
amounts provided to the institution as described in
subsection (d)(1).
(c) Priority.--In awarding grant funds under this section,
the Secretary shall give priority to eligible entities that--
(1) demonstrate a record of successfully training
students, as determined by the Secretary, who practice
medicine in underserved rural communities;
(2) demonstrate that an existing academic program
of the eligible entity produces a high percentage, as
determined by the Secretary, of graduates from such
program who practice medicine in underserved rural
communities;
(3) demonstrate rural community institutional
partnerships, through such mechanisms as matching or
contributory funding, documented in-kind services for
implementation, or existence of training partners with
interprofessional expertise in community health center
training locations or other similar facilities; or
(4) submit, as part of the application of the
entity under subsection (b), a plan for the long-term
tracking of where the graduates of such entity practice
medicine.
(d) Use of Funds.--
(1) Establishment.--An eligible entity receiving a
grant under this section shall use the funds made
available under such grant to establish, improve, or
expand a rural-focused training program (referred to in
this section as the ``Program'') meeting the
requirements described in this subsection and to carry
out such program.
(2) Structure of program.--An eligible entity
shall--
(A) enroll no fewer than 10 students per
class year into the Program; and
(B) develop criteria for admission to the
Program that gives priority to students--
(i) who have originated from or
lived for a period of 2 or more years
in an underserved rural community; and
(ii) who express a commitment to
practice medicine in an underserved
rural community.
(3) Curricula.--The Program shall require students
to enroll in didactic coursework and clinical
experience particularly applicable to medical practice
in underserved rural communities, including--
(A) clinical rotations in underserved rural
communities, and in applicable specialties, or
other coursework or clinical experience deemed
appropriate by the Secretary; and
(B) in addition to core school curricula,
additional coursework or training experiences
focused on medical issues prevalent in
underserved rural communities.
(4) Residency placement assistance.--Where
available, the Program shall assist all students of the
Program in obtaining clinical training experiences in
locations with postgraduate programs offering residency
training opportunities in underserved rural
communities, or in local residency training programs
that support and train physicians to practice in
underserved rural communities.
(5) Program student cohort support.--The Program
shall provide and require all students of the Program
to participate in group activities designed to further
develop, maintain, and reinforce the original
commitment of such students to practice in an
underserved rural community.
(e) Annual Reporting.--An eligible entity receiving a grant
under this section shall submit an annual report to the
Secretary on the success of the Program, based on criteria the
Secretary determines appropriate, including the residency
program selection of graduating students who participated in
the Program.
(f) Regulations.--Not later than 60 days after the date of
enactment of this section, the Secretary shall by regulation
define `underserved rural community' for purposes of this
section.
(g) Supplement Not Supplant.--Any eligible entity receiving
funds under this section shall use such funds to supplement,
not supplant, any other Federal, State, and local funds that
would otherwise be expended by such entity to carry out the
activities described in this section.
(h) Maintenance of Effort.--With respect to activities for
which funds awarded under this section are to be expended, the
entity shall agree to maintain expenditures of non-Federal
amounts for such activities at a level that is not less than
the level of such expenditures maintained by the entity for the
fiscal year preceding the fiscal year for which the entity
receives a grant under this section.
(i) Authorization of Appropriations.--There are authorized
to be appropriated $4,000,000 for each of the fiscal years 2010
through 2013.
PART D--INTERDISCIPLINARY, COMMUNITY-BASED LINKAGES
SEC. 750. [294] GENERAL PROVISIONS.
(a) Collaboration.--To be eligible to receive assistance
under this part, an academic institution shall use such
assistance in collaboration with 2 or more disciplines.
(b) Activities.--An entity shall use assistance under this
part to carry out innovative demonstration projects for
strategic workforce supplementation activities as needed to
meet national goals for interdisciplinary, community-based
linkages. Such assistance may be used consistent with this
part--
(1) to develop and support training programs;
(2) for faculty development;
(3) for model demonstration programs;
(4) for the provision of stipends for fellowship
trainees;
(5) to provide technical assistance; and
(6) for other activities that will produce outcomes
consistent with the purposes of this part.
SEC. 751. [294A] AREA HEALTH EDUCATION CENTERS.
(a) Establishment of Awards.--The Secretary shall make the
following 2 types of awards in accordance with this section:
(1) Infrastructure development award.--The
Secretary shall make awards to eligible entities to
enable such entities to initiate health care workforce
educational programs or to continue to carry out
comparable programs that are operating at the time the
award is made by planning, developing, operating, and
evaluating an area health education center program.
(2) Point of service maintenance and enhancement
award.--The Secretary shall make awards to eligible
entities to maintain and improve the effectiveness and
capabilities of an existing area health education
center program, and make other modifications to the
program that are appropriate due to changes in
demographics, needs of the populations served, or other
similar issues affecting the area health education
center program. For the purposes of this section, the
term ``Program'' refers to the area health education
center program.
(b) Eligible Entities; Application.--
(1) Eligible entities.--
(A) Infrastructure development.--For
purposes of subsection (a)(1), the term
``eligible entity'' means a school of medicine
or osteopathic medicine, an incorporated
consortium of such schools, or the parent
institutions of such a school. With respect to
a State in which no area health education
center program is in operation, the Secretary
may award a grant or contract under subsection
(a)(1) to a school of nursing.
(B) Point of service maintenance and
enhancement.--For purposes of subsection
(a)(2), the term ``eligible entity'' means an
entity that has received funds under this
section, is operating an area health education
center program, including an area health
education center or centers, and has a center
or centers that are no longer eligible to
receive financial assistance under subsection
(a)(1).
(2) Application.--An eligible entity desiring to
receive an award under this section shall submit to the
Secretary an application at such time, in such manner,
and containing such information as the Secretary may
require.
(c) Use of Funds.--
(1) Required activities.--An eligible entity shall
use amounts awarded under a grant under subsection
(a)(1) or (a)(2) to carry out the following activities:
(A) Develop and implement strategies, in
coordination with the applicable one-stop
delivery system under section 134(c) of the
Workforce Investment Act of 1998, to recruit
individuals from underrepresented minority
populations or from disadvantaged or rural
backgrounds into health professions, and
support such individuals in attaining such
careers.
(B) Develop and implement strategies to
foster and provide community-based training and
education to individuals seeking careers in
health professions within underserved areas for
the purpose of developing and maintaining a
diverse health care workforce that is prepared
to deliver high-quality care, with an emphasis
on primary care, in underserved areas or for
health disparity populations, in collaboration
with other Federal and State health care
workforce development programs, the State
workforce agency, and local workforce
investment boards, and in health care safety
net sites.
(C) Prepare individuals to more effectively
provide health services to underserved areas
and health disparity populations through field
placements or preceptorships in conjunction
with community-based organizations, accredited
primary care residency training programs,
Federally qualified health centers, rural
health clinics, public health departments, or
other appropriate facilities.
(D) Conduct and participate in
interdisciplinary training that involves
physicians, physician assistants, nurse
practitioners, nurse midwives, dentists,
psychologists, pharmacists, optometrists,
community health workers, public and allied
health professionals, or other health
professionals, as practicable.
(E) Deliver or facilitate continuing
education and information dissemination
programs for health care professionals, with an
emphasis on individuals providing care in
underserved areas and for health disparity
populations.
(F) Propose and implement effective program
and outcomes measurement and evaluation
strategies.
(G) Establish a youth public health program
to expose and recruit high school students into
health careers, with a focus on careers in
public health.
(2) Innovative opportunities.--An eligible entity
may use amounts awarded under a grant under subsection
(a)(1) or subsection (a)(2) to carry out any of the
following activities:
(A) Develop and implement innovative
curricula in collaboration with community-based
accredited primary care residency training
programs, Federally qualified health centers,
rural health clinics, behavioral and mental
health facilities, public health departments,
or other appropriate facilities, with the goal
of increasing the number of primary care
physicians and other primary care providers
prepared to serve in underserved areas and
health disparity populations.
(B) Coordinate community-based
participatory research with academic health
centers, and facilitate rapid flow and
dissemination of evidence-based health care
information, research results, and best
practices to improve quality, efficiency, and
effectiveness of health care and health care
systems within community settings.
(C) Develop and implement other strategies
to address identified workforce needs and
increase and enhance the health care workforce
in the area served by the area health education
center program.
(d) Requirements.--
(1) Area health education center program.--In
carrying out this section, the Secretary shall ensure
the following:
(A) An entity that receives an award under
this section shall conduct at least 10 percent
of clinical education required for medical
students in community settings that are removed
from the primary teaching facility of the
contracting institution for grantees that
operate a school of medicine or osteopathic
medicine. In States in which an entity that
receives an award under this section is a
nursing school or its parent institution, the
Secretary shall alternatively ensure that--
(i) the nursing school conducts at
least 10 percent of clinical education
required for nursing students in
community settings that are remote from
the primary teaching facility of the
school; and
(ii) the entity receiving the award
maintains a written agreement with a
school of medicine or osteopathic
medicine to place students from that
school in training sites in the area
health education center program area.
(B) An entity receiving funds under
subsection (a)(2) does not distribute such
funding to a center that is eligible to receive
funding under subsection (a)(1).
(2) Area health education center.--The Secretary
shall ensure that each area health education center
program includes at least 1 area health education
center, and that each such center--
(A) is a public or private organization
whose structure, governance, and operation is
independent from the awardee and the parent
institution of the awardee;
(B) is not a school of medicine or
osteopathic medicine, the parent institution of
such a school, or a branch campus or other
subunit of a school of medicine or osteopathic
medicine or its parent institution, or a
consortium of such entities;
(C) designates an underserved area or
population to be served by the center which is
in a location removed from the main location of
the teaching facilities of the schools
participating in the program with such center
and does not duplicate, in whole or in part,
the geographic area or population served by any
other center;
(D) fosters networking and collaboration
among communities and between academic health
centers and community-based centers;
(E) serves communities with a demonstrated
need of health professionals in partnership
with academic medical centers;
(F) addresses the health care workforce
needs of the communities served in coordination
with the public workforce investment system;
and
(G) has a community-based governing or
advisory board that reflects the diversity of
the communities involved.
(e) Matching Funds.--With respect to the costs of operating
a program through a grant under this section, to be eligible
for financial assistance under this section, an entity shall
make available (directly or through contributions from State,
county or municipal governments, or the private sector)
recurring non-Federal contributions in cash or in kind, toward
such costs in an amount that is equal to not less than 50
percent of such costs. At least 25 percent of the total
required non-Federal contributions shall be in cash. An entity
may apply to the Secretary for a waiver of not more than 75
percent of the matching fund amount required by the entity for
each of the first 3 years the entity is funded through a grant
under subsection (a)(1).
(f) Limitation.--Not less than 75 percent of the total
amount provided to an area health education center program
under subsection (a)(1) or (a)(2) shall be allocated to the
area health education centers participating in the program
under this section. To provide needed flexibility to newly
funded area health education center programs, the Secretary may
waive the requirement in the sentence for the first 2 years of
a new area health education center program funded under
subsection (a)(1).
(g) Award.--An award to an entity under this section shall
be not less than $250,000 annually per area health education
center included in the program involved. If amounts
appropriated to carry out this section are not sufficient to
comply with the preceding sentence, the Secretary may reduce
the per center amount provided for in such sentence as
necessary, provided the distribution established in subsection
(j)(2) is maintained.
(h) Project Terms.--
(1) In general.--Except as provided in paragraph
(2), the period during which payments may be made under
an award under subsection (a)(1) may not exceed--
(A) in the case of a program, 12 years; or
(B) in the case of a center within a
program, 6 years.
(2) Exception.--The periods described in paragraph
(1) shall not apply to programs receiving point of
service maintenance and enhancement awards under
subsection (a)(2) to maintain existing centers and
activities.
(i) Inapplicability of Provision.--Notwithstanding any
other provision of this title, section 791(a) shall not apply
to an area health education center funded under this section.
(j) Authorization of Appropriations.--
(1) In general.--There is authorized to be
appropriated to carry out this section $125,000,000 for
each of the fiscal years 2010 through 2014.
(2) Requirements.--Of the amounts appropriated for
a fiscal year under paragraph (1)--
(A) not more than 35 percent shall be used
for awards under subsection (a)(1);
(B) not less than 60 percent shall be used
for awards under subsection (a)(2);
(C) not more than 1 percent shall be used
for grants and contracts to implement outcomes
evaluation for the area health education
centers; and
(D) not more than 4 percent shall be used
for grants and contracts to provide technical
assistance to entities receiving awards under
this section.
(3) Carryover funds.--An entity that receives an
award under this section may carry over funds from 1
fiscal year to another without obtaining approval from
the Secretary. In no case may any funds be carried over
pursuant to the preceding sentence for more than 3
years.
(k) Sense of Congress.--It is the sense of the Congress
that every State have an area health education center program
in effect under this section.
SEC. 752. [294B] CONTINUING EDUCATIONAL SUPPORT FOR HEALTH
PROFESSIONALS SERVING IN UNDERSERVED COMMUNITIES.
(a) In General.--The Secretary shall make grants to, and
enter into contracts with, eligible entities to improve health
care, increase retention, increase representation of minority
faculty members, enhance the practice environment, and provide
information dissemination and educational support to reduce
professional isolation through the timely dissemination of
research findings using relevant resources.
(b) Eligible Entities.--For purposes of this section, the
term ``eligible entity'' means an entity described in section
799(b).
(c) Application.--An eligible entity desiring to receive an
award under this section shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require.
(d) Use of Funds.--An eligible entity shall use amounts
awarded under a grant or contract under this section to provide
innovative supportive activities to enhance education through
distance learning, continuing educational activities,
collaborative conferences, and electronic and telelearning
activities, with priority for primary care.
(e) Authorization.--There is authorized to be appropriated
to carry out this section $5,000,000 for each of the fiscal
years 2010 through 2014, and such sums as may be necessary for
each subsequent fiscal year.
SEC. 753. [294C] EDUCATION AND TRAINING RELATING TO GERIATRICS.
(a) Geriatric Education Centers.--
(1) In general.--The Secretary shall award grants
or contracts under this section to entities described
in paragraphs \1\ (1), (3), or (4) of section 799B, and
section 801(2), for the establishment or operation of
geriatric education centers.
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\1\ So in law. Probably should read ``paragraph''.
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(2) Requirements.--A geriatric education center is
a program that--
(A) improves the training of health
professionals in geriatrics, including
geriatric residencies, traineeships, or
fellowships;
(B) develops and disseminates curricula
relating to the treatment of the health
problems of elderly individuals;
(C) supports the training and retraining of
faculty to provide instruction in geriatrics;
(D) supports continuing education of health
professionals who provide geriatric care; and
(E) provides students with clinical
training in geriatrics in nursing homes,
chronic and acute disease hospitals, ambulatory
care centers, and senior centers.
(b) Geriatric Training Regarding Physicians and Dentists.--
(1) In general.--The Secretary may make grants to,
and enter into contracts with, schools of medicine,
schools of osteopathic medicine, teaching hospitals,
and graduate medical education programs, for the
purpose of providing support (including residencies,
traineeships, and fellowships) for geriatric training
projects to train physicians, dentists and behavioral
and mental health professionals who plan to teach
geriatric medicine, geriatric behavioral or mental
health, or geriatric dentistry.
(2) Requirements.--Each project for which a grant
or contract is made under this subsection shall--
(A) be staffed by full-time teaching
physicians who have experience or training in
geriatric medicine or geriatric behavioral or
mental health;
(B) be staffed, or enter into an agreement
with an institution staffed by full-time or
part-time teaching dentists who have experience
or training in geriatric dentistry;
(C) be staffed, or enter into an agreement
with an institution staffed by full-time or
part-time teaching behavioral mental health
professionals who have experience or training
in geriatric behavioral or mental health;
(D) be based in a graduate medical
education program in internal medicine or
family medicine or in a department of
geriatrics or behavioral or mental health;
(E) provide training in geriatrics and
exposure to the physical and mental
disabilities of elderly individuals through a
variety of service rotations, such as geriatric
consultation services, acute care services,
dental services, geriatric behavioral or mental
health units, day and home care programs,
rehabilitation services, extended care
facilities, geriatric ambulatory care and
comprehensive evaluation units, and community
care programs for elderly mentally retarded
individuals; and
(F) provide training in geriatrics through
one or both of the training options described
in subparagraphs (A) and (B) of paragraph (3).
(3) Training options.--The training options
referred to in subparagraph (F) of paragraph (2) shall
be as follows:
(A) A 1-year retraining program in
geriatrics for--
(i) physicians who are faculty
members in departments of internal
medicine, family medicine, gynecology,
geriatrics, and behavioral or mental
health at schools of medicine and
osteopathic medicine;
(ii) dentists who are faculty
members at schools of dentistry or at
hospital departments of dentistry; and
(iii) behavioral or mental health
professionals who are faculty members
in departments of behavioral or mental
health; and
(B) A 2-year internal medicine or family
medicine fellowship program providing emphasis
in geriatrics, which shall be designed to
provide training in clinical geriatrics and
geriatrics research for--
(i) physicians who have completed
graduate medical education programs in
internal medicine, family medicine,
behavioral or mental health, neurology,
gynecology, or rehabilitation medicine;
(ii) dentists who have demonstrated
a commitment to an academic career and
who have completed postdoctoral dental
training, including postdoctoral dental
education programs or who have relevant
advanced training or experience; and
(iii) behavioral or mental health
professionals who have completed
graduate medical education programs in
behavioral or mental health.
(4) Definitions.--For purposes of this subsection:
(A) The term ``graduate medical education
program'' means a program sponsored by a school
of medicine, a school of osteopathic medicine,
a hospital, or a public or private institution
that--
(i) offers postgraduate medical
training in the specialties and
subspecialties of medicine; and
(ii) has been accredited by the
Accreditation Council for Graduate
Medical Education or the American
Osteopathic Association through its
Committee on Postdoctoral Training.
(B) The term ``post-doctoral dental
education program'' means a program sponsored
by a school of dentistry, a hospital, or a
public or private institution that--
(i) offers post-doctoral training
in the specialties of dentistry,
advanced education in general
dentistry, or a dental general practice
residency; and
(ii) has been accredited by the
Commission on Dental Accreditation.
(c) Geriatric Faculty Fellowships.--
(1) Establishment of program.--The Secretary shall
establish a program to provide Geriatric Academic
Career Awards to eligible individuals to promote the
career development of such individuals as academic
geriatricians.
(2) Eligible individuals.--To be eligible to
receive an Award under paragraph (1), an individual
shall--
(A) be board certified or board eligible in
internal medicine, family practice, psychiatry,
or licensed dentistry, or have completed any
required training in a discipline and employed
in an accredited health professions school that
is approved by the Secretary;
(B) have completed an approved fellowship
program in geriatrics or have completed
specialty training in geriatrics as required by
the discipline and any addition geriatrics
training as required by the Secretary; and
(C) have a junior (non-tenured) faculty
appointment at an accredited (as determined by
the Secretary) school of medicine, osteopathic
medicine, nursing, social work, psychology,
dentistry, pharmacy, or other allied health
disciplines in an accredited health professions
school that is approved by the Secretary.
(3) Limitations.--No Award under paragraph (1) may
be made to an eligible individual unless the
individual--
(A) has submitted to the Secretary an
application, at such time, in such manner, and
containing such information as the Secretary
may require, and the Secretary has approved
such application;
(B) provides, in such form and manner as
the Secretary may require, assurances that the
individual will meet the service requirement
described in paragraph (6); and
(C) provides, in such form and manner as
the Secretary may require, assurances that the
individual has a full-time faculty appointment
in a health professions institution and
documented commitment from such institution to
spend 75 percent of the total time of such
individual on teaching and developing skills in
interdisciplinary education in geriatrics.
(4) Maintenance of effort.--An eligible individual
that receives an Award under paragraph (1) shall
provide assurances to the Secretary that funds provided
to the eligible individual under this subsection will
be used only to supplement, not to supplant, the amount
of Federal, State, and local funds otherwise expended
by the eligible individual.
(5) Amount and term.--
(A) Amount.--The amount of an Award under
this section for individuals who are physicians
shall equal $50,000 for fiscal year 1998,
adjusted for subsequent fiscal years to reflect
the increase in the Consumer Price Index. The
Secretary shall determine the amount of an
Award under this section for individuals who
are not physicians.
(B) Term.--The term of any Award made under
this subsection shall not exceed 5 years.
(C) Payment to institution.--The Secretary
shall make payments to institutions which
include schools of medicine, osteopathic
medicine, nursing, social work, psychology,
dentistry, and pharmacy, or other allied health
discipline in an accredited health professions
school that is approved by the Secretary.
(6) Service requirement.--An individual who
receives an Award under this subsection shall provide
training in clinical geriatrics, including the training
of interdisciplinary teams of health care
professionals. The provision of such training shall
constitute at least 75 percent of the obligations of
such individual under the Award.
(d) Geriatric Workforce Development.--
(1) In general.--The Secretary shall award grants
or contracts under this subsection to entities that
operate a geriatric education center pursuant to
subsection (a)(1).
(2) Application.--To be eligible for an award under
paragraph (1), an entity described in such paragraph
shall submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require.
(3) Use of funds.--Amounts awarded under a grant or
contract under paragraph (1) shall be used to--
(A) carry out the fellowship program
described in paragraph (4); and
(B) carry out 1 of the 2 activities
described in paragraph (5).
(4) Fellowship program.--
(A) In general.--Pursuant to paragraph (3),
a geriatric education center that receives an
award under this subsection shall use such
funds to offer short-term intensive courses
(referred to in this subsection as a
``fellowship'') that focus on geriatrics,
chronic care management, and long-term care
that provide supplemental training for faculty
members in medical schools and other health
professions schools with programs in
psychology, pharmacy, nursing, social work,
dentistry, public health, allied health, or
other health disciplines, as approved by the
Secretary. Such a fellowship shall be open to
current faculty, and appropriately credentialed
volunteer faculty and practitioners, who do not
have formal training in geriatrics, to upgrade
their knowledge and clinical skills for the
care of older adults and adults with functional
limitations and to enhance their
interdisciplinary teaching skills.
(B) Location.--A fellowship shall be
offered either at the geriatric education
center that is sponsoring the course, in
collaboration with other geriatric education
centers, or at medical schools, schools of
dentistry, schools of nursing, schools of
pharmacy, schools of social work, graduate
programs in psychology, or allied health and
other health professions schools approved by
the Secretary with which the geriatric
education centers are affiliated.
(C) CME credit.--Participation in a
fellowship under this paragraph shall be
accepted with respect to complying with
continuing health profession education
requirements. As a condition of such
acceptance, the recipient shall agree to
subsequently provide a minimum of 18 hours of
voluntary instructional support through a
geriatric education center that is providing
clinical training to students or trainees in
long-term care settings.
(5) Additional required activities described.--
Pursuant to paragraph (3), a geriatric education center
that receives an award under this subsection shall use
such funds to carry out 1 of the following 2
activities.
(A) Family caregiver and direct care
provider training.--A geriatric education
center that receives an award under this
subsection shall offer at least 2 courses each
year, at no charge or nominal cost, to family
caregivers and direct care providers that are
designed to provide practical training for
supporting frail elders and individuals with
disabilities. The Secretary shall require such
Centers to work with appropriate community
partners to develop training program content
and to publicize the availability of training
courses in their service areas. All family
caregiver and direct care provider training
programs shall include instruction on the
management of psychological and behavioral
aspects of dementia, communication techniques
for working with individuals who have dementia,
and the appropriate, safe, and effective use of
medications for older adults.
(B) Incorporation of best practices.--A
geriatric education center that receives an
award under this subsection shall develop and
include material on depression and other mental
disorders common among older adults, medication
safety issues for older adults, and management
of the psychological and behavioral aspects of
dementia and communication techniques with
individuals who have dementia in all training
courses, where appropriate.
(6) Targets.--A geriatric education center that
receives an award under this subsection shall meet
targets approved by the Secretary for providing
geriatric training to a certain number of faculty or
practitioners during the term of the award, as well as
other parameters established by the Secretary.
(7) Amount of award.--An award under this
subsection shall be in an amount of $150,000. Not more
than 24 geriatric education centers may receive an
award under this subsection.
(8) Maintenance of effort.--A geriatric education
center that receives an award under this subsection
shall provide assurances to the Secretary that funds
provided to the geriatric education center under this
subsection will be used only to supplement, not to
supplant, the amount of Federal, State, and local funds
otherwise expended by the geriatric education center.
(9) Authorization of appropriations.--In addition
to any other funding available to carry out this
section, there is authorized to be appropriated to
carry out this subsection, $10,800,000 for the period
of fiscal year 2011 through 2014.
(e) Geriatric Career Incentive Awards.--
(1) In general.--The Secretary shall award grants
or contracts under this section to individuals
described in paragraph (2) to foster greater interest
among a variety of health professionals in entering the
field of geriatrics, long-term care, and chronic care
management.
(2) Eligible individuals.--To be eligible to
received an award under paragraph (1), an individual
shall--
(A) be an advanced practice nurse, a
clinical social worker, a pharmacist, or
student of psychology who is pursuing a
doctorate or other advanced degree in
geriatrics or related fields in an accredited
health professions school; and
(B) submit to the Secretary an application
at such time, in such manner, and containing
such information as the Secretary may require.
(3) Condition of award.--As a condition of
receiving an award under this subsection, an individual
shall agree that, following completion of the award
period, the individual will teach or practice in the
field of geriatrics, long-term care, or chronic care
management for a minimum of 5 years under guidelines
set by the Secretary.
(4) Authorization of appropriations.--There is
authorized to be appropriated to carry out this
subsection, $10,000,000 for the period of fiscal years
2011 through 2013.
SEC. 754. [294D] QUENTIN N. BURDICK PROGRAM FOR RURAL INTERDISCIPLINARY
TRAINING.
(a) Grants.--The Secretary may make grants or contracts
under this section to help entities fund authorized activities
under an application approved under subsection (c).
(b) Use of Amounts.--
(1) In general.--Amounts provided under subsection
(a) shall be used by the recipients to fund
interdisciplinary training projects designed to--
(A) use new and innovative methods to train
health care practitioners to provide services
in rural areas;
(B) demonstrate and evaluate innovative
interdisciplinary methods and models designed
to provide access to cost-effective
comprehensive health care;
(C) deliver health care services to
individuals residing in rural areas;
(D) enhance the amount of relevant research
conducted concerning health care issues in
rural areas; and
(E) increase the recruitment and retention
of health care practitioners from rural areas
and make rural practice a more attractive
career choice for health care practitioners.
(2) Methods.--A recipient of funds under subsection
(a) may use various methods in carrying out the
projects described in paragraph (1), including--
(A) the distribution of stipends to
students of eligible applicants;
(B) the establishment of a post-doctoral
fellowship program;
(C) the training of faculty in the economic
and logistical problems confronting rural
health care delivery systems; or
(D) the purchase or rental of
transportation and telecommunication equipment
where the need for such equipment due to unique
characteristics of the rural area is
demonstrated by the recipient.
(3) Administration.--
(A) In general.--An applicant shall not use
more than 10 percent of the funds made
available to such applicant under subsection
(a) for administrative expenses.
(B) Training.--Not more than 10 percent of
the individuals receiving training with funds
made available to an applicant under subsection
(a) shall be trained as doctors of medicine or
doctors of osteopathy.
(C) Limitation.--An institution that
receives a grant under this section shall use
amounts received under such grant to
supplement, not supplant, amounts made
available by such institution for activities of
the type described in subsection (b)(1) in the
fiscal year preceding the year for which the
grant is received.
(c) Applications.--Applications submitted for assistance
under this section shall--
(1) be jointly submitted by at least two eligible
applicants with the express purpose of assisting
individuals in academic institutions in establishing
long-term collaborative relationships with health care
providers in rural areas; and
(2) designate a rural health care agency or
agencies for clinical treatment or training, including
hospitals, community health centers, migrant health
centers, rural health clinics, community behavioral and
mental health centers, long-term care facilities,
Native Hawaiian health centers, or facilities operated
by the Indian Health Service or an Indian tribe or
tribal organization or Indian organization under a
contract with the Indian Health Service under the
Indian Self-Determination Act.
(d) Definitions.--For the purposes of this section, the
term ``rural'' means geographic areas that are located outside
of standard metropolitan statistical areas.
SEC. 755. [294E] ALLIED HEALTH AND OTHER DISCIPLINES.
(a) In General.--The Secretary may make grants or contracts
under this section to help entities fund activities of the type
described in subsection (b).
(b) Activities.--Activities of the type described in this
subsection include the following:
(1) Assisting entities in meeting the costs
associated with expanding or establishing programs that
will increase the number of individuals trained in
allied health professions. Programs and activities
funded under this paragraph may include--
(A) those that expand enrollments in allied
health professions with the greatest shortages
or whose services are most needed by the
elderly;
(B) those that provide rapid transition
training programs in allied health fields to
individuals who have baccalaureate degrees in
health-related sciences;
(C) those that establish community-based
allied health training programs that link
academic centers to rural clinical settings;
(D) those that provide career advancement
training for practicing allied health
professionals;
(E) those that expand or establish clinical
training sites for allied health professionals
in medically underserved or rural communities
in order to increase the number of individuals
trained;
(F) those that develop curriculum that will
emphasize knowledge and practice in the areas
of prevention and health promotion, geriatrics,
long-term care, home health and hospice care,
and ethics;
(G) those that expand or establish
interdisciplinary training programs that
promote the effectiveness of allied health
practitioners in geriatric assessment and the
rehabilitation of the elderly;
(H) those that expand or establish
demonstration centers to emphasize innovative
models to link allied health clinical practice,
education, and research;
(I) those that provide financial assistance
(in the form of traineeships) to students who
are participants in any such program; and
(i) who plan to pursue a career in
an allied health field that has a
demonstrated personnel shortage; and
(ii) who agree upon completion of
the training program to practice in a
medically underserved community;
that shall be utilized to assist in the payment
of all or part of the costs associated with
tuition, fees and such other stipends as the
Secretary may consider necessary; and
(J) those to meet the costs of projects to
plan, develop, and operate or maintain graduate
programs in behavioral and mental health
practice.
(2) Planning and implementing projects in
preventive and primary care training for podiatric
physicians in approved or provisionally approved
residency programs that shall provide financial
assistance in the form of traineeships to residents who
participate in such projects and who plan to specialize
in primary care.
(3) Carrying out demonstration projects in which
chiropractors and physicians collaborate to identify
and provide effective treatment for spinal and lower-
back conditions.
SEC. 756. [294E-1] MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING
GRANTS.
(a) Grants Authorized.--The Secretary may award grants to
eligible institutions of higher education to support the
recruitment of students for, and education and clinical
experience of the students in--
(1) baccalaureate, master's, and doctoral degree
programs of social work, as well as the development of
faculty in social work;
(2) accredited master's, doctoral, internship, and
post-doctoral residency programs of psychology for the
development and implementation of interdisciplinary
training of psychology graduate students for providing
behavioral and mental health services, including
substance abuse prevention and treatment services;
(3) accredited institutions of higher education or
accredited professional training programs that are
establishing or expanding internships or other field
placement programs in child and adolescent mental
health in psychiatry, psychology, school psychology,
behavioral pediatrics, psychiatric nursing, social
work, school social work, substance abuse prevention
and treatment, marriage and family therapy, school
counseling, or professional counseling; and
(4) State-licensed mental health nonprofit and for-
profit organizations to enable such organizations to
pay for programs for preservice or in-service training
of paraprofessional child and adolescent mental health
workers.
(b) Eligibility Requirements.--To be eligible for a grant
under this section, an institution shall demonstrate--
(1) participation in the institutions' programs of
individuals and groups from different racial, ethnic,
cultural, geographic, religious, linguistic, and class
backgrounds, and different genders and sexual
orientations;
(2) knowledge and understanding of the concerns of
the individuals and groups described in subsection (a);
(3) any internship or other field placement program
assisted under the grant will prioritize cultural and
linguistic competency;
(4) the institution will provide to the Secretary
such data, assurances, and information as the Secretary
may require; and
(5) with respect to any violation of the agreement
between the Secretary and the institution, the
institution will pay such liquidated damages as
prescribed by the Secretary by regulation.
(c) Institutional Requirement.--For grants authorized under
subsection (a)(1), at least 4 of the grant recipients shall be
historically black colleges or universities or other minority-
serving institutions.
(d) Priority.--
(1) In selecting the grant recipients in social
work under subsection (a)(1), the Secretary shall give
priority to applicants that--
(A) are accredited by the Council on Social
Work Education;
(B) have a graduation rate of not less than
80 percent for social work students; and
(C) exhibit an ability to recruit social
workers from and place social workers in areas
with a high need and high demand population.
(2) In selecting the grant recipients in graduate
psychology under subsection (a)(2), the Secretary shall
give priority to institutions in which training focuses
on the needs of vulnerable groups such as older adults
and children, individuals with mental health or
substance-related disorders, victims of abuse or trauma
and of combat stress disorders such as posttraumatic
stress disorder and traumatic brain injuries, homeless
individuals, chronically ill persons, and their
families.
(3) In selecting the grant recipients in training
programs in child and adolescent mental health under
subsections (a)(3) and (a)(4), the Secretary shall give
priority to applicants that--
(A) have demonstrated the ability to
collect data on the number of students trained
in child and adolescent mental health and the
populations served by such students after
graduation or completion of preservice or in-
service training;
(B) have demonstrated familiarity with
evidence-based methods in child and adolescent
mental health services, including substance
abuse prevention and treatment services;
(C) have programs designed to increase the
number of professionals and paraprofessionals
serving high-priority populations and to
applicants who come from high-priority
communities and plan to serve medically
underserved populations, in health professional
shortage areas, or in medically underserved
areas;
(D) offer curriculum taught collaboratively
with a family on the consumer and family lived
experience or the importance of family-
professional or family-paraprofessional
partnerships; and
(E) provide services through a community
mental health program described in section
1913(b)(1).
(e) Authorization of Appropriation.--For the fiscal years
2010 through 2013, there is authorized to be appropriated to
carry out this section--
(1) $8,000,000 for training in social work in
subsection (a)(1);
(2) $12,000,000 for training in graduate psychology
in subsection (a)(2), of which not less than
$10,000,000 shall be allocated for doctoral,
postdoctoral, and internship level training;
(3) $10,000,000 for training in professional child
and adolescent mental health in subsection (a)(3); and
(4) $5,000,000 for training in paraprofessional
child and adolescent work in subsection (a)(4).
SEC. 757. [294F] ADVISORY COMMITTEE ON INTERDISCIPLINARY, COMMUNITY-
BASED LINKAGES.
(a) Establishment.--The Secretary shall establish an
advisory committee to be known as the Advisory Committee on
Interdisciplinary, Community-Based Linkages (in this section
referred to as the ``Advisory Committee'').
(b) Composition.--
(1) In general.--The Secretary shall determine the
appropriate number of individuals to serve on the
Advisory Committee. Such individuals shall not be
officers or employees of the Federal Government.
(2) Appointment.--Not later than 90 days after the
date of enactment of this Act \1\, the Secretary shall
appoint the members of the Advisory Committee from
among individuals who are health professionals from
schools of the types described in sections
751(b)(1)(A), 753(b), and 755(b). In making such
appointments, the Secretary shall ensure a fair balance
between the health professions, that at least 75
percent of the members of the Advisory Committee are
health professionals, a broad geographic representation
of members and a balance between urban and rural
members. Members shall be appointed based on their
competence, interest, and knowledge of the mission of
the profession involved.
---------------------------------------------------------------------------
\1\ So in law. The reference to ``this Act'' means the Public
Health Service Act, which was enacted July 1, 1944. Probably should be
a reference to the Health Professions Education Partnerships Act of
1998, which added section 756. That Act is Public Law 105-392, enacted
November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541)
added section 756.)
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(3) Minority representation.--In appointing the
members of the Advisory Committee under paragraph (2),
the Secretary shall ensure the adequate representation
of women and minorities.
(c) Terms.--
(1) In general.--A member of the Advisory Committee
shall be appointed for a term of 3 years, except that
of the members first appointed--
(A) \1/3\ of the members shall serve for a
term of 1 year;
(B) \1/3\ of the members shall serve for a
term of 2 years; and
(C) \1/3\ of the members shall serve for a
term of 3 years.
(2) Vacancies.--
(A) In general.--A vacancy on the Advisory
Committee shall be filled in the manner in
which the original appointment was made and
shall be subject to any conditions which
applied with respect to the original
appointment.
(B) Filling unexpired term.--An individual
chosen to fill a vacancy shall be appointed for
the unexpired term of the member replaced.
(d) Duties.--The Advisory Committee shall--
(1) provide advice and recommendations to the
Secretary concerning policy and program development and
other matters of significance concerning the activities
under this part;
(2) not later than 3 years after the date of
enactment of this section, and annually thereafter,
prepare and submit to the Secretary, and the Committee
on Labor and Human Resources of the Senate, and the
Committee on Commerce of the House of Representatives,
a report describing the activities of the Committee,
including findings and recommendations made by the
Committee concerning the activities under this part;
(3) develop, publish, and implement performance
measures for programs under this part;
(4) develop and publish guidelines for longitudinal
evaluations (as described in section 761(d)(2)) for
programs under this part; and
(5) recommend appropriation levels for programs
under this part.
(e) Meetings and Documents.--
(1) Meetings.--The Advisory Committee shall meet
not less than 3 times each year. Such meetings shall be
held jointly with other related entities established
under this title where appropriate.
(2) Documents.--Not later than 14 days prior to the
convening of a meeting under paragraph (1), the
Advisory Committee shall prepare and make available an
agenda of the matters to be considered by the Advisory
Committee at such meeting. At any such meeting, the
Advisory Council \1\ shall distribute materials with
respect to the issues to be addressed at the meeting.
Not later than 30 days after the adjourning of such a
meeting, the Advisory Committee shall prepare and make
available a summary of the meeting and any actions
taken by the Committee based upon the meeting.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``Advisory Committee''. See
section 103 of Public Law 105-392 (112 Stat. 3541).
---------------------------------------------------------------------------
(f) Compensation and Expenses.--
(1) Compensation.--Each member of the Advisory
Committee shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic pay
prescribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each
day (including travel time) during which such member is
engaged in the performance of the duties of the
Committee.
(2) Expenses.--The members of the Advisory
Committee shall be allowed travel expenses, including
per diem in lieu of subsistence, at rates authorized
for employees of agencies under subchapter I of chapter
57 of title 5, United States Code, while away from
their homes or regular places of business in the
performance of services for the Committee.
(g) FACA.--The Federal Advisory Committee Act shall apply
to the Advisory Committee under this section only to the extent
that the provisions of such Act do not conflict with the
requirements of this section.
SEC. 758. [294H] INTERDISCIPLINARY TRAINING AND EDUCATION ON DOMESTIC
VIOLENCE AND OTHER TYPES OF VIOLENCE AND ABUSE.
(a) Grants.--The Secretary, acting through the Director of
the Health Resources and Services Administration, shall award
grants under this section to develop interdisciplinary training
and education programs that provide undergraduate, graduate,
post-graduate medical, nursing (including advanced practice
nursing students), and other health professions students with
an understanding of, and clinical skills pertinent to, domestic
violence, sexual assault, stalking, and dating violence.
(b) Eligibility.--To be eligible to receive a grant under
this section an entity shall--
(1) be an accredited school of allopathic or
osteopathic medicine;
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require, including--
(A) information to demonstrate that the
applicant includes the meaningful participation
of a school of nursing and at least one other
school of health professions or graduate
program in public health, dentistry, social
work, midwifery, or behavioral and mental
health;
(B) strategies for the dissemination and
sharing of curricula and other educational
materials developed under the grant to other
interested medical and nursing schools and
national resource repositories for materials on
domestic violence and sexual assault; and
(C) a plan for consulting with community-
based coalitions or individuals who have
experience and expertise in issues related to
domestic violence, sexual assault, dating
violence, and stalking for services provided
under the program carried out under the grant.
(c) Use of Funds.--
(1) Required uses.--Amounts provided under a grant
under this section shall be used to--
(A) fund interdisciplinary training and
education projects that are designed to train
medical, nursing, and other health professions
students and residents to identify and provide
health care services (including mental or
behavioral health care services and referrals
to appropriate community services) to
individuals who are experiencing \1\ or who
have experienced domestic violence, sexual
assault, and stalking or dating violence; and
---------------------------------------------------------------------------
\1\ Section 4(c) of Public Law 109-271 amended section 758(c)(1)(A)
of the Public Health Service[s] Act. The reference to the amended law
should have been made to the Public Health Service Act but was executed
to reflect the probable intent of Congress.
---------------------------------------------------------------------------
(B) plan and develop culturally competent
clinical components for integration into
approved residency training programs that
address health issues related to domestic
violence, sexual assault, dating violence, and
stalking, along with other forms of violence as
appropriate, and include the primacy of victim
safety and confidentiality.
(2) Permissive uses.--Amounts provided under a
grant under this section may be used to--
(A) offer community-based training
opportunities in rural areas for medical,
nursing, and other students and residents on
domestic violence, sexual assault, stalking,
and dating violence, and other forms of
violence and abuse, which may include the use
of distance learning networks and other
available technologies needed to reach isolated
rural areas; or
(B) provide stipends to students who are
underrepresented in the health professions as
necessary to promote and enable their
participation in clerkships, preceptorships, or
other offsite training experiences that are
designed to develop health care clinical skills
related to domestic violence, sexual assault,
dating violence, and stalking.
(3) Requirements.--
(A) Confidentiality and safety.--Grantees
under this section shall ensure that all
educational programs developed with grant funds
address issues of confidentiality and patient
safety, and that faculty and staff associated
with delivering educational components are
fully trained in procedures that will protect
the immediate and ongoing security of the
patients, patient records, and staff. Advocacy-
based coalitions or other expertise available
in the community shall be consulted on the
development and adequacy of confidentially and
security procedures, and shall be fairly
compensated by grantees for their services.
(B) Rural programs.--Rural training
programs carried out under paragraph (2)(A)
shall reflect adjustments in protocols and
procedures or referrals that may be needed to
protect the confidentiality and safety of
patients who live in small or isolated
communities and who are currently or have
previously experienced violence or abuse.
(4) Child and elder abuse.--Issues related to child
and elder abuse may be addressed as part of a
comprehensive programmatic approach implemented under a
grant under this section.
(d) Requirements of Grantees.--
(1) Limitation on administrative expenses.--A
grantee shall not use more than 10 percent of the
amounts received under a grant under this section for
administrative expenses.
(2) Contribution of funds.--A grantee under this
section, and any entity receiving assistance under the
grant for training and education, shall contribute non-
Federal funds, either directly or through in-kind
contributions, to the costs of the activities to be
funded under the grant in an amount that is not less
than 25 percent of the total cost of such activities.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $3,000,000 for
each of fiscal years 2007 through 2011. Amounts appropriated
under this subsection shall remain available until expended.
SEC. 759. [294I] PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE.
(a) In General.--The Secretary may make awards of grants,
cooperative agreements, and contracts to health professions
schools, hospices, and other public and private entities for
the development and implementation of programs to provide
education and training to health care professionals in pain
care.
(b) Certain Topics.--An award may be made under subsection
(a) only if the applicant for the award agrees that the program
carried out with the award will include information and
education on--
(1) recognized means for assessing, diagnosing,
treating, and managing pain and related signs and
symptoms, including the medically appropriate use of
controlled substances;
(2) applicable laws, regulations, rules, and
policies on controlled substances, including the degree
to which misconceptions and concerns regarding such
laws, regulations, rules, and policies, or the
enforcement thereof, may create barriers to patient
access to appropriate and effective pain care;
(3) interdisciplinary approaches to the delivery of
pain care, including delivery through specialized
centers providing comprehensive pain care treatment
expertise;
(4) cultural, linguistic, literacy, geographic, and
other barriers to care in underserved populations; and
(5) recent findings, developments, and improvements
in the provision of pain care.
(c) Evaluation of Programs.--The Secretary shall (directly
or through grants or contracts) provide for the evaluation of
programs implemented under subsection (a) in order to determine
the effect of such programs on knowledge and practice of pain
care.
(d) Pain Care Defined.--For purposes of this section the
term ``pain care'' means the assessment, diagnosis, treatment,
or management of acute or chronic pain regardless of causation
or body location.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, such sums as may
be necessary for each of the fiscal years 2010 through 2012.
Amounts appropriated under this subsection shall remain
available until expended.
PART E--HEALTH PROFESSIONS AND PUBLIC HEALTH WORKFORCE
Subpart 1--Health Professions Workforce Information and Analysis
SEC. 761. [294N] HEALTH PROFESSIONS WORKFORCE INFORMATION AND ANALYSIS.
(a) Purpose.--It is the purpose of this section to--
(1) provide for the development of information
describing the health professions workforce and the
analysis of workforce related issues; and
(2) provide necessary information for decision-
making regarding future directions in health
professions and nursing programs in response to
societal and professional needs.
(b) National Center for Health Care Workforce Analysis.--
(1) Establishment.--The Secretary shall establish
the National Center for Health Workforce Analysis
(referred to in this section as the ``National
Center'').
(2) Purposes.--The National Center, in coordination
to the extent practicable with the National Health Care
Workforce Commission (established in section 5101 of
the Patient Protection and Affordable Care Act), and
relevant regional and State centers and agencies,
shall--
(A) provide for the development of
information describing and analyzing the health
care workforce and workforce related issues;
(B) carry out the activities under section
792(a);
(C) annually evaluate programs under this
title;
(D) develop and publish performance
measures and benchmarks for programs under this
title; and
(E) establish, maintain, and publicize a
national Internet registry of each grant
awarded under this title and a database to
collect data from longitudinal evaluations (as
described in subsection (d)(2)) on performance
measures (as developed under sections
749(d)(3), 757(d)(3), and 762(a)(3)).
(3) Collaboration and data sharing.--
(A) In general.--The National Center shall
collaborate with Federal agencies and relevant
professional and educational organizations or
societies for the purpose of linking data
regarding grants awarded under this title.
(B) Contracts for health workforce
analysis.--For the purpose of carrying out the
activities described in subparagraph (A), the
National Center may enter into contracts with
relevant professional and educational
organizations or societies.
(c) State and Regional Centers for Health Workforce
Analysis.--
(1) In general.--The Secretary shall award grants
to, or enter into contracts with, eligible entities for
purposes of--
(A) collecting, analyzing, and reporting
data regarding programs under this title to the
National Center and to the public; and
(B) providing technical assistance to local
and regional entities on the collection,
analysis, and reporting of data.
(2) Eligible entities.--To be eligible for a grant
or contract under this subsection, an entity shall--
(A) be a State, a State workforce
investment board, a public health or health
professions school, an academic health center,
or an appropriate public or private nonprofit
entity; and
(B) submit to the Secretary an application
at such time, in such manner, and containing
such information as the Secretary may require.
(d) Increase in Grants for Longitudinal Evaluations.--
(1) In general.--The Secretary shall increase the
amount awarded to an eligible entity under this title
for a longitudinal evaluation of individuals who have
received education, training, or financial assistance
from programs under this title.
(2) Capability.--A longitudinal evaluation shall be
capable of--
(A) studying practice patterns; and
(B) collecting and reporting data on
performance measures developed under sections
749(d)(3), 757(d)(3), and 762(a)(3).
(3) Guidelines.--A longitudinal evaluation shall
comply with guidelines issued under sections 749(d)(4),
757(d)(4), and 762(a)(4).
(4) Eligible entities.--To be eligible to obtain an
increase under this section, an entity shall be a
recipient of a grant or contract under this title.
(e) Authorization of Appropriations.--
(1) In general.--
(A) National center.--To carry out
subsection (b), there are authorized to be
appropriated $7,500,000 for each of fiscal
years 2010 through 2014.
(B) State and regional centers.--To carry
out subsection (c), there are authorized to be
appropriated $4,500,000 for each of fiscal
years 2010 through 2014.
(C) Grants for longitudinal evaluations.--
To carry out subsection (d), there are
authorized to be appropriated such sums as may
be necessary for fiscal years 2010 through
2014.
(2) Reservation.--Of the amounts appropriated under
subsection (a) \1\ for a fiscal year, the Secretary
shall reserve not less than $600,000 for conducting
health professions research and for carrying out data
collection and analysis in accordance with section 792.
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\1\ The reference to ``subsection (a)'' in subsection (e)(2)
probably should read ``paragraph (1)''. Paragraph (4) of section
5103(a) of PL 111-148 probably should have been designated as a
subparagraph (B) of paragraph (3) of such section. As such, the
amendment instruction in paragraph (4) to strike ``subsection (a)'' and
insert ``paragraph (1)'' could not be executed since it did not specify
to which subsection to carry out the amendment.
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(3) Availability of additional funds.--Amounts
otherwise appropriated for programs or activities under
this title may be used for activities under subsection
(b) with respect to the programs or activities from
which such amounts were made available.
SEC. 762. [294O] ADVISORY COUNCIL ON GRADUATE MEDICAL EDUCATION.
(a) Establishment; Duties.--There is established the
Council on Graduate Medical Education (in this section referred
to as the ``Council''). The Council shall--
(1) make recommendations to the Secretary of Health
and Human Services (in this section referred to as the
``Secretary''), and to the Committee on Labor and Human
Resources of the Senate, and the Committee on Energy
and Commerce of the House of Representatives, with
respect to--
(A) the supply and distribution of
physicians in the United States;
(B) current and future shortages or
excesses of physicians in medical and surgical
specialties and subspecialties;
(C) issues relating to foreign medical
school graduates;
(D) appropriate Federal policies with
respect to the matters specified in
subparagraphs (A), (B), and (C), including
policies concerning changes in the financing of
undergraduate and graduate medical education
programs and changes in the types of medical
education training in graduate medical
education programs;
(E) appropriate efforts to be carried out
by hospitals, schools of medicine, schools of
osteopathic medicine, and accrediting bodies
with respect to the matters specified in
subparagraphs (A), (B), and (C), including
efforts for changes in undergraduate and
graduate medical education programs; and
(F) deficiencies in, and needs for
improvements in, existing data bases concerning
the supply and distribution of, and
postgraduate training programs for, physicians
in the United States and steps that should be
taken to eliminate those deficiencies;
(2) encourage entities providing graduate medical
education to conduct activities to voluntarily achieve
the recommendations of the Council under paragraph
(1)(E);
(3) develop, publish, and implement performance
measures for programs under this title, except for
programs under part C or D;
(4) develop and publish guidelines for longitudinal
evaluations (as described in section 761(d)(2)) for
programs under this title, except for programs under
part C or D; and
(5) recommend appropriation levels for programs
under this title, except for programs under part C or
D.
(b) Composition.--The Council shall be composed of--
(1) the Assistant Secretary for Health or the
designee of the Assistant Secretary;
(2) the Administrator of the Health Care Financing
Administration;
(3) the Chief Medical Director of the Department of
Veterans Affairs;
(4) 6 members appointed by the Secretary to include
representatives of practicing primary care physicians,
national and specialty physician organizations, foreign
medical graduates, and medical student and house staff
associations;
(5) 4 members appointed by the Secretary to include
representatives of schools of medicine and osteopathic
medicine and public and private teaching hospitals; and
(6) 4 members appointed by the Secretary to include
representatives of health insurers, business, and
labor.
(c) Terms of Appointed Members.--
(1) In general; staggered rotation.--Members of the
Council appointed under paragraphs (4), (5), and (6) of
subsection (b) shall be appointed for a term of 4
years, except that the term of office of the members
first appointed shall expire, as designated by the
Secretary at the time of appointment, 4 at the end of 1
year, 4 at the end of 2 years, 3 at the end of 3 years,
and 3 at the end of 4 years.
(2) Date certain for appointment.--The Secretary
shall appoint the first members to the Council under
paragraphs (4), (5), and (6) of subsection (b) within
60 days after the date of enactment of this section.
(d) Chair.--The Council shall elect one of its members as
Chairman of the Council.
(e) Quorum.--Nine members of the Council shall constitute a
quorum, but a lesser number may hold hearings.
(f) Vacancies.--Any vacancy in the Council shall not affect
its power to function.
(g) Compensation.--Each member of the Council who is not
otherwise employed by the United States Government shall
receive compensation at a rate equal to the daily rate
prescribed for GS-18 under the General Schedule under section
5332 of title 5, United States Code, for each day, including
traveltime, such member is engaged in the actual performance of
duties as a member of the Council. A member of the Council who
is an officer or employee of the United States Government shall
serve without additional compensation. All members of the
Council shall be reimbursed for travel, subsistence, and other
necessary expenses incurred by them in the performance of their
duties.
(h) Certain Authorities and Duties.--
(1) Authorities.--In order to carry out the
provisions of this section, the Council is authorized
to--
(A) collect such information, hold such
hearings, and sit and act at such times and
places, either as a whole or by subcommittee,
and request the attendance and testimony of
such witnesses and the production of such
books, records, correspondence, memoranda,
papers, and documents as the Council or such
subcommittee may consider available; and
(B) request the cooperation and assistance
of Federal departments, agencies, and
instrumentalities, and such departments,
agencies, and instrumentalities are authorized
to provide such cooperation and assistance.
(2) Coordination of activities.--The Council shall
coordinate its activities with the activities of the
Secretary under section 792 of the Public Health
Service Act. The Secretary shall, in cooperation with
the Council and pursuant to the recommendations of the
Council, take such steps as are practicable to
eliminate deficiencies in the data base established
under such section 792 and shall make available in its
reports such comprehensive data sets as are developed
pursuant to this section.
(i) Requirement Regarding Reports.--In the reports required
under subsection (a), the Council shall specify its activities
during the period for which the report is made.
(j) Final Report.--Not later than April 1, 2002, the
Council shall submit a final report under subsection (a).
(k) Termination.--The Council shall terminate
September 30, 2003 \1\.
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\1\ Appropriations Acts for the Department of Health and Human
Services for fiscal years 2004 and 2005 provided for the continued
operation of the Council. See section 219 of division E of Public Law
108-199 (118 Stat. 255) and section 218 of division F of Public Law
108-447 (118 Stat. 3141). Each of such sections refers to ``the Council
on Graduate Education established by section 301 of Public Law 102-
408''. Such section 301 was transferred to the Public Health Service
Act as section 762 above by section 104(b) of Public Law 105-392 (112
Stat. 3552).
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(l) Funding.--Amounts otherwise appropriated under this
title may be utilized by the Secretary to support the
activities of the Council.
SEC. 763. [294P] PEDIATRIC RHEUMATOLOGY.
(a) In General.--The Secretary, acting through the
appropriate agencies, shall evaluate whether the number of
pediatric rheumatologists is sufficient to address the health
care needs of children with arthritis and related conditions,
and if the Secretary determines that the number is not
sufficient, shall develop strategies to help address the
shortfall.
(b) Report to Congress.--Not later than October 1, 2001,
the Secretary shall submit to the Congress a report describing
the results of the evaluation under subsection (a), and as
applicable, the strategies developed under such subsection.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
Subpart 2--Public Health Workforce
SEC. 765. [295] GENERAL PROVISIONS.
(a) In General.--The Secretary may award grants or
contracts to eligible entities to increase the number of
individuals in the public health workforce, to enhance the
quality of such workforce, and to enhance the ability of the
workforce to meet national, State, and local health care needs.
(b) Eligibility.--To be eligible to receive a grant or
contract under subsection (a) an entity shall--
(1) be--
(A) a health professions school, including
an accredited school or program of public
health, health administration, preventive
medicine, or dental public health or a school
providing health management programs;
(B) an academic health center;
(C) a State or local government; or
(D) any other appropriate public or private
nonprofit entity; and
(2) prepare and submit to the Secretary an
application at such time, in such manner, and
containing such information as the Secretary may
require.
(c) Preference.--In awarding grants or contracts under this
section the Secretary may grant a preference to entities--
(1) serving individuals who are from disadvantaged
backgrounds (including underrepresented racial and
ethnic minorities); and
(2) graduating large proportions of individuals who
serve in underserved communities.
(d) Activities.--Amounts provided under a grant or contract
awarded under this section may be used for--
(1) the costs of planning, developing, or operating
demonstration training programs;
(2) faculty development;
(3) trainee support;
(4) technical assistance;
(5) to meet the costs of projects--
(A) to plan and develop new residency
training programs and to maintain or improve
existing residency training programs in
preventive medicine and dental public health,
that have available full-time faculty members
with training and experience in the fields of
preventive medicine and dental public health;
and
(B) to provide financial assistance to
residency trainees enrolled in such programs;
(6) the retraining of existing public health
workers as well as for increasing the supply of new
practitioners to address priority public health,
preventive medicine, public health dentistry, and
health administration needs;
(7) preparing public health professionals for
employment at the State and community levels;
(8) public health workforce loan repayment
programs; or
(9) other activities that may produce outcomes that
are consistent with the purposes of this section.
(e) Traineeships.--
(1) In general.--With respect to amounts used under
this section for the training of health professionals,
such training programs shall be designed to--
(A) make public health education more
accessible to the public and private health
workforce;
(B) increase the relevance of public health
academic preparation to public health practice
in the future;
(C) provide education or training for
students from traditional on-campus programs in
practice-based sites; or
(D) develop educational methods and
distance-based approaches or technology that
address adult learning requirements and
increase knowledge and skills related to
community-based cultural diversity in public
health education.
(2) Severe shortage disciplines.--Amounts provided
under grants or contracts under this section may be
used for the operation of programs designed to award
traineeships to students in accredited schools of
public health who enter educational programs in fields
where there is a severe shortage of public health
professionals, including epidemiology, biostatistics,
environmental health, toxicology, public health
nursing, nutrition, preventive medicine, maternal and
child health, and behavioral and mental health
professions.
SEC. 766. [295A] PUBLIC HEALTH TRAINING CENTERS.
(a) In General.--The Secretary may make grants or contracts
for the operation of public health training centers.
(b) Eligible Entities.--
(1) In general.--A public health training center
shall be an accredited school of public health, or
another public or nonprofit private institution
accredited for the provision of graduate or specialized
training in public health, that plans, develops,
operates, and evaluates projects that are in
furtherance of the goals established by the Secretary
for the year 2000 in the areas of preventive medicine,
health promotion and disease prevention, or improving
access to and quality of health services in medically
underserved communities.
(2) Preference.--In awarding grants or contracts
under this section the Secretary shall give preference
to accredited schools of public health.
(c) Certain Requirements.--With respect to a public health
training center, an award may not be made under subsection (a)
unless the program agrees that it--
(1) will establish or strengthen field placements
for students in public or nonprofit private health
agencies or organizations;
(2) will involve faculty members and students in
collaborative projects to enhance public health
services to medically underserved communities;
(3) will specifically designate a geographic area
or medically underserved population to be served by the
center that shall be in a location removed from the
main location of the teaching facility of the school
that is participating in the program with such center;
and
(4) will assess the health personnel needs of the
area to be served by the center and assist in the
planning and development of training programs to meet
such needs.
SEC. 767. [295B] PUBLIC HEALTH TRAINEESHIPS.
(a) In General.--The Secretary may make grants to
accredited schools of public health, and to other public or
nonprofit private institutions accredited for the provision of
graduate or specialized training in public health, for the
purpose of assisting such schools and institutions in providing
traineeships to individuals described in subsection (b)(3).
(b) Certain Requirements.--
(1) Amount.--The amount of any grant under this
section shall be determined by the Secretary.
(2) Use of grant.--Traineeships awarded under
grants made under subsection (a) shall provide for
tuition and fees and such stipends and allowances
(including travel and subsistence expenses and
dependency allowances) for the trainees as the
Secretary may deem necessary.
(3) Eligible individuals.--The individuals referred
to in subsection (a) are individuals who are pursuing a
course of study in a health professions field in which
there is a severe shortage of health professionals
(which fields include the fields of epidemiology,
environmental health, biostatistics, toxicology,
nutrition, and maternal and child health).
SEC. 768. [295C] PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAINING GRANT
PROGRAM.
(a) Grants.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration and in consultation with the Director of the
Centers for Disease Control and Prevention, shall award grants
to, or enter into contracts with, eligible entities to provide
training to graduate medical residents in preventive medicine
specialties.
(b) Eligibility.--To be eligible for a grant or contract
under subsection (a), an entity shall be--
(1) an accredited school of public health or school
of medicine or osteopathic medicine;
(2) an accredited public or private nonprofit
hospital;
(3) a State, local, or tribal health department; or
(4) a consortium of 2 or more entities described in
paragraphs (1) through (3).
(c) Use of Funds.--Amounts received under a grant or
contract under this section shall be used to--
(1) plan, develop (including the development of
curricula), operate, or participate in an accredited
residency or internship program in preventive medicine
or public health;
(2) defray the costs of practicum experiences, as
required in such a program; and
(3) establish, maintain, or improve--
(A) academic administrative units
(including departments, divisions, or other
appropriate units) in preventive medicine and
public health; or
(B) programs that improve clinical teaching
in preventive medicine and public health.
(d) Report.--The Secretary shall submit to the Congress an
annual report on the program carried out under this section.
SEC. 769. [295D] HEALTH ADMINISTRATION TRAINEESHIPS AND SPECIAL
PROJECTS.
(a) In General.--The Secretary may make grants to State or
local governments (that have in effect preventive medical and
dental public health residency programs) or public or nonprofit
private educational entities (including graduate schools of
social work and business schools that have health management
programs) that offer a program described in subsection (b)--
(1) to provide traineeships for students enrolled
in such a program; and
(2) to assist accredited programs health
administration in the development or improvement of
programs to prepare students for employment with public
or nonprofit private entities.
(b) Relevant Programs.--The program referred to in
subsection (a) is an accredited program in health
administration, hospital administration, or health policy
analysis and planning, which program is accredited by a body or
bodies approved for such purpose by the Secretary of Education
and which meets such other quality standards as the Secretary
of Health and Human Services by regulation may prescribe.
(c) Preference in Making Grants.--In making grants under
subsection (a), the Secretary shall give preference to
qualified applicants that meet the following conditions:
(1) Not less than 25 percent of the graduates of
the applicant are engaged in full-time practice
settings in medically underserved communities.
(2) The applicant recruits and admits students from
medically underserved communities.
(3) For the purpose of training students, the
applicant has established relationships with public and
nonprofit providers of health care in the community
involved.
(4) In training students, the applicant emphasizes
employment with public or nonprofit private entities.
(d) Certain Provisions Regarding Traineeships.--
(1) Use of grant.--Traineeships awarded under
grants made under subsection (a) shall provide for
tuition and fees and such stipends and allowances
(including travel and subsistence expenses and
dependency allowances) for the trainees as the
Secretary may deem necessary.
(2) Preference for certain students.--Each entity
applying for a grant under subsection (a) for
traineeships shall assure to the satisfaction of the
Secretary that the entity will give priority to
awarding the traineeships to students who demonstrate a
commitment to employment with public or nonprofit
private entities in the fields with respect to which
the traineeships are awarded.
SEC. 770. [295E] AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out this
subpart, there is authorized to be appropriated $43,000,000 for
fiscal year 2011, and such sums as may be necessary for each of
the fiscal years 2012 through 2015.
(b) Limitation Regarding Certain Program.--In obligating
amounts appropriated under subsection (a), the Secretary may
not obligate more than 30 percent for carrying out section 767.
Subpart 3--Recruitment and Retention Programs
SEC. 775. [295F] INVESTMENT IN TOMORROW'S PEDIATRIC HEALTH CARE
WORKFORCE.
(a) Establishment.--The Secretary shall establish and carry
out a pediatric specialty loan repayment program under which
the eligible individual agrees to be employed full-time for a
specified period (which shall not be less than 2 years) in
providing pediatric medical subspecialty, pediatric surgical
specialty, or child and adolescent mental and behavioral health
care, including substance abuse prevention and treatment
services.
(b) Program Administration.--Through the program
established under this section, the Secretary shall enter into
contracts with qualified health professionals under which--
(1) such qualified health professionals will agree
to provide pediatric medical subspecialty, pediatric
surgical specialty, or child and adolescent mental and
behavioral health care in an area with a shortage of
the specified pediatric subspecialty that has a
sufficient pediatric population to support such
pediatric subspecialty, as determined by the Secretary;
and
(2) the Secretary agrees to make payments on the
principal and interest of undergraduate, graduate, or
graduate medical education loans of professionals
described in paragraph (1) of not more than $35,000 a
year for each year of agreed upon service under such
paragraph for a period of not more than 3 years during
the qualified health professional's--
(A) participation in an accredited
pediatric medical subspecialty, pediatric
surgical specialty, or child and adolescent
mental health subspecialty residency or
fellowship; or
(B) employment as a pediatric medical
subspecialist, pediatric surgical specialist,
or child and adolescent mental health
professional serving an area or population
described in such paragraph.
(c) In General.--
(1) Eligible individuals.--
(A) Pediatric medical specialists and
pediatric surgical specialists.--For purposes
of contracts with respect to pediatric medical
specialists and pediatric surgical specialists,
the term ``qualified health professional''
means a licensed physician who--
(i) is entering or receiving
training in an accredited pediatric
medical subspecialty or pediatric
surgical specialty residency or
fellowship; or
(ii) has completed (but not prior
to the end of the calendar year in
which this section is enacted) the
training described in subparagraph (B).
(B) Child and adolescent mental and
behavioral health.--For purposes of contracts
with respect to child and adolescent mental and
behavioral health care, the term ``qualified
health professional'' means a health care
professional who--
(i) has received specialized
training or clinical experience in
child and adolescent mental health in
psychiatry, psychology, school
psychology, behavioral pediatrics,
psychiatric nursing, social work,
school social work, substance abuse
disorder prevention and treatment,
marriage and family therapy, school
counseling, or professional counseling;
(ii) has a license or certification
in a State to practice allopathic
medicine, osteopathic medicine,
psychology, school psychology,
psychiatric nursing, social work,
school social work, marriage and family
therapy, school counseling, or
professional counseling; or
(iii) is a mental health service
professional who completed (but not
before the end of the calendar year in
which this section is enacted)
specialized training or clinical
experience in child and adolescent
mental health described in clause (i).
(2) Additional eligibility requirements.--The
Secretary may not enter into a contract under this
subsection with an eligible individual unless--
(A) the individual agrees to work in, or
for a provider serving, a health professional
shortage area or medically underserved area, or
to serve a medically underserved population;
(B) the individual is a United States
citizen or a permanent legal United States
resident; and
(C) if the individual is enrolled in a
graduate program, the program is accredited,
and the individual has an acceptable level of
academic standing (as determined by the
Secretary).
(d) Priority.--In entering into contracts under this
subsection, the Secretary shall give priority to applicants
who--
(1) are or will be working in a school or other
pre-kindergarten, elementary, or secondary education
setting;
(2) have familiarity with evidence-based methods
and cultural and linguistic competence health care
services; and
(3) demonstrate financial need.
(e) Authorization of Appropriations.--There is authorized
to be appropriated $30,000,000 for each of fiscal years 2010
through 2014 to carry out subsection (c)(1)(A) and $20,000,000
for each of fiscal years 2010 through 2013 to carry out
subsection (c)(1)(B).
SEC. 776. [295F-1] PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
(a) Establishment.--The Secretary shall establish the
Public Health Workforce Loan Repayment Program (referred to in
this section as the ``Program'') to assure an adequate supply
of public health professionals to eliminate critical public
health workforce shortages in Federal, State, local, and tribal
public health agencies.
(b) Eligibility.--To be eligible to participate in the
Program, an individual shall--
(1)(A) be accepted for enrollment, or be enrolled,
as a student in an accredited academic educational
institution in a State or territory in the final year
of a course of study or program leading to a public
health or health professions degree or certificate; and
have accepted employment with a Federal, State, local,
or tribal public health agency, or a related training
fellowship, as recognized by the Secretary, to commence
upon graduation; \1\
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\1\ So in law. There should probably be an ``or'' at the end of
subparagraph (A).
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(B)(i) have graduated, during the preceding 10-year
period, from an accredited educational institution in a
State or territory and received a public health or
health professions degree or certificate; and
(ii) be employed by, or have accepted employment
with, a Federal, State, local, or tribal public health
agency or a related training fellowship, as recognized
by the Secretary;
(2) be a United States citizen; and
(3)(A) submit an application to the Secretary to
participate in the Program;
(B) execute a written contract as required in
subsection (c); and
(4) not have received, for the same service, a
reduction of loan obligations under section 455(m),
428J, 428K, 428L, or 460 of the Higher Education Act of
1965.
(c) Contract.--The written contract (referred to in this
section as the ``written contract'') between the Secretary and
an individual shall contain--
(1) an agreement on the part of the Secretary that
the Secretary will repay on behalf of the individual
loans incurred by the individual in the pursuit of the
relevant degree or certificate in accordance with the
terms of the contract;
(2) an agreement on the part of the individual that
the individual will serve in the full-time employment
of a Federal, State, local, or tribal public health
agency or a related fellowship program in a position
related to the course of study or program for which the
contract was awarded for a period of time (referred to
in this section as the `period of obligated service')
equal to the greater of--
(A) 3 years; or
(B) such longer period of time as
determined appropriate by the Secretary and the
individual;
(3) an agreement, as appropriate, on the part of
the individual to relocate to a priority service area
(as determined by the Secretary) in exchange for an
additional loan repayment incentive amount to be
determined by the Secretary;
(4) a provision that any financial obligation of
the United States arising out of a contract entered
into under this section and any obligation of the
individual that is conditioned thereon, is contingent
on funds being appropriated for loan repayments under
this section;
(5) a statement of the damages to which the United
States is entitled, under this section for the
individual's breach of the contract; and
(6) such other statements of the rights and
liabilities of the Secretary and of the individual, not
inconsistent with this section.
(d) Payments.--
(1) In general.--A loan repayment provided for an
individual under a written contract under the Program
shall consist of payment, in accordance with paragraph
(2), on behalf of the individual of the principal,
interest, and related expenses on government and
commercial loans received by the individual regarding
the undergraduate or graduate education of the
individual (or both), which loans were made for tuition
expenses incurred by the individual.
(2) Payments for years served.--For each year of
obligated service that an individual contracts to serve
under subsection (c) the Secretary may pay up to
$35,000 on behalf of the individual for loans described
in paragraph (1). With respect to participants under
the Program whose total eligible loans are less than
$105,000, the Secretary shall pay an amount that does
not exceed \1/3\ of the eligible loan balance for each
year of obligated service of the individual.
(3) Tax liability.--For the purpose of providing
reimbursements for tax liability resulting from
payments under paragraph (2) on behalf of an
individual, the Secretary shall, in addition to such
payments, make payments to the individual in an amount
not to exceed 39 percent of the total amount of loan
repayments made for the taxable year involved.
(e) Postponing Obligated Service.--With respect to an
individual receiving a degree or certificate from a health
professions or other related school, the date of the initiation
of the period of obligated service may be postponed as approved
by the Secretary.
(f) Breach of Contract.--An individual who fails to comply
with the contract entered into under subsection (c) shall be
subject to the same financial penalties as provided for under
section 338E for breaches of loan repayment contracts under
section 338B.
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $195,000,000 for
fiscal year 2010, and such sums as may be necessary for each of
fiscal years 2011 through 2015.
SEC. 777. [295F-2] TRAINING FOR MID-CAREER PUBLIC AND ALLIED HEALTH
PROFESSIONALS.
(a) In General.--The Secretary may make grants to, or enter
into contracts with, any eligible entity to award scholarships
to eligible individuals to enroll in degree or professional
training programs for the purpose of enabling mid-career
professionals in the public health and allied health workforce
to receive additional training in the field of public health
and allied health.
(b) Eligibility.--
(1) Eligible entity.--The term ``eligible entity''
indicates an accredited educational institution that
offers a course of study, certificate program, or
professional training program in public or allied
health or a related discipline, as determined by the
Secretary
(2) Eligible individuals.--The term ``eligible
individuals'' includes those individuals employed in
public and allied health positions at the Federal,
State, tribal, or local level who are interested in
retaining or upgrading their education.
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $60,000,000 for
fiscal year 2010 and such sums as may be necessary for each of
fiscal years 2011 through 2015. Fifty percent of appropriated
funds shall be allotted to public health mid-career
professionals and 50 percent shall be allotted to allied health
mid-career professionals.
SEC. 778. [295F-3] FELLOWSHIP TRAINING IN APPLIED PUBLIC HEALTH
EPIDEMIOLOGY, PUBLIC HEALTH LABORATORY SCIENCE,
PUBLIC HEALTH INFORMATICS, AND EXPANSION OF THE
EPIDEMIC INTELLIGENCE SERVICE.
(a) In General.--The Secretary may carry out activities to
address documented workforce shortages in State and local
health departments in the critical areas of applied public
health epidemiology and public health laboratory science and
informatics and may expand the Epidemic Intelligence Service.
(b) Specific Uses.--In carrying out subsection (a), the
Secretary shall provide for the expansion of existing
fellowship programs operated through the Centers for Disease
Control and Prevention in a manner that is designed to
alleviate shortages of the type described in subsection (a).
(c) Other Programs.--The Secretary may provide for the
expansion of other applied epidemiology training programs that
meet objectives similar to the objectives of the programs
described in subsection (b).
(d) Work Obligation.--Participation in fellowship training
programs under this section shall be deemed to be service for
purposes of satisfying work obligations stipulated in contracts
under section 338I(j).
(e) General Support.--Amounts may be used from grants
awarded under this section to expand the Public Health
Informatics Fellowship Program at the Centers for Disease
Control and Prevention to better support all public health
systems at all levels of government.
(f) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $39,500,000 for
each of fiscal years 2010 through 2013, of which--
(1) $5,000,000 shall be made available in each such
fiscal year for epidemiology fellowship training
program activities under subsections (b) and (c);
(2) $5,000,000 shall be made available in each such
fiscal year for laboratory fellowship training programs
under subsection (b);
(3) $5,000,000 shall be made available in each such
fiscal year for the Public Health Informatics
Fellowship Program under subsection (e); and
(4) $24,500,000 shall be made available for
expanding the Epidemic Intelligence Service under
subsection (a).
PART F--GENERAL PROVISIONS
SEC. 791. [295J] PREFERENCES AND REQUIRED INFORMATION IN CERTAIN
PROGRAMS.
(a) Preferences in Making Awards.--
(1) In general.--Subject to paragraph (2), in
making awards of grants or contracts under any of
sections 747 and 750, the Secretary shall give
preference to any qualified applicant that--
(A) has a high rate for placing graduates
in practice settings having the principal focus
of serving residents of medically underserved
communities;
(B) during the 2-year period preceding the
fiscal year for which such an award is sought,
has achieved a significant increase in the rate
of placing graduates in such settings; or
(C) utilizes a longitudinal evaluation (as
described in section 761(d)(2)) and reports
data from such system to the national workforce
database (as established under section
761(b)(2)(E)).
(2) Limitation regarding peer review.--For purposes
of paragraph (1), the Secretary may not give an
applicant preference if the proposal of the applicant
is ranked at or below the 20th percentile of proposals
that have been recommended for approval by peer review
groups.
(b) Definition.--For purposes of this section, the term
``graduate'' means, unless otherwise specified, an individual
who has successfully completed all training and residency
requirements necessary for full certification in the health
profession selected by the individual.
(c) Exceptions for New Programs.--
(1) In general.--To permit new programs to compete
equitably for funding under this section, those new
programs that meet at least 4 of the criteria described
in paragraph (3) shall qualify for a funding preference
under this section.
(2) Definition.--As used in this subsection, the
term ``new program'' means any program that has
graduated less than three classes. Upon graduating at
least three classes, a program shall have the
capability to provide the information necessary to
qualify the program for the general funding preferences
described in subsection (a).
(3) Criteria.--The criteria referred to in
paragraph (1) are the following:
(A) The mission statement of the program
identifies a specific purpose of the program as
being the preparation of health professionals
to serve underserved populations.
(B) The curriculum of the program includes
content which will help to prepare
practitioners to serve underserved populations.
(C) Substantial clinical training
experience is required under the program in
medically underserved communities.
(D) A minimum of 20 percent of the clinical
faculty of the program spend at least 50
percent of their time providing or supervising
care in medically underserved communities.
(E) The entire program or a substantial
portion of the program is physically located in
a medically underserved community.
(F) Student assistance, which is linked to
service in medically underserved communities
following graduation, is available to the
students in the program.
(G) The program provides a placement
mechanism for deploying graduates to medically
underserved communities.
SEC. 792. [295K] HEALTH PROFESSIONS DATA.
(a) In General.--The Secretary shall establish a program,
including a uniform health professions data reporting system,
to collect, compile, and analyze data on health professions
personnel which program shall initially include data respecting
all physicians and dentists in the States. The Secretary is
authorized to expand the program to include, whenever he
determines it necessary, the collection, compilation, and
analysis of data respecting pharmacists, optometrists,
podiatrists, veterinarians, public health personnel,
audiologists, speech pathologists, health care administration
personnel, nurses, allied health personnel, medical
technologists, chiropractors, clinical psychologists,
professional counselors, and any other health personnel in
States designated by the Secretary to be included in the
program. Such data shall include data respecting the training,
licensure status (including permanent, temporary, partial,
limited, or institutional), place or places of practice,
professional specialty, practice characteristics, place and
date of birth, sex, and socioeconomic background of health
professions personnel and such other demographic information
regarding health professions personnel as the Secretary may
require.
(b) Certain Authorities and Requirements.--
(1) Sources of information.--In carrying out
subsection (a), the Secretary shall collect available
information from appropriate local, State, and Federal
agencies and other appropriate sources.
(2) Contracts for studies of health professions.--
The Secretary shall conduct or enter into contracts for
the conduct of analytic and descriptive studies of the
health professions, including evaluations and
projections of the supply of, and requirements for, the
health professions by specialty and geographic
location. Such studies shall include studies
determining by specialty and geographic location the
number of health professionals (including allied health
professionals and health care administration personnel)
who are members of minority groups, including
Hispanics, and studies providing by specialty and
geographic location evaluations and projections of the
supply of, and requirements for, health professionals
(including allied health professionals and health care
administration personnel) to serve minority groups,
including Hispanics.
(3) Grants and contracts regarding states.--The
Secretary is authorized to make grants and to enter
into contracts with States (or an appropriate nonprofit
private entity in any State) for the purpose of
participating in the program established under
subsection (a). The Secretary shall determine the
amount and scope of any such grant or contract. To be
eligible for a grant or contract under this paragraph a
State or entity shall submit an application in such
form and manner and containing such information as the
Secretary shall require. Such application shall include
reasonable assurance, satisfactory to the Secretary,
that--
(A) such State (or nonprofit entity within
a State) will establish a program of mandatory
annual registration of the health professions
personnel described in subsection (a) who
reside or practice in such State and of health
institutions licensed by such State, which
registration shall include such information as
the Secretary shall determine to be
appropriate;
(B) such State or entity shall collect such
information and report it to the Secretary in
such form and manner as the Secretary shall
prescribe; and
(C) such State or entity shall comply with
the requirements of subsection (e).
(d) \1\ Reports to Congress.--The Secretary shall submit to
the Congress on October 1, 1993, and biennially thereafter, the
following reports:
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\1\ So in law. Probably should be redesignated as (c).
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(1) A comprehensive report regarding the status of
health personnel according to profession, including a
report regarding the analytic and descriptive studies
conducted under this section.
(2) A comprehensive report regarding applicants to,
and students enrolled in, programs and institutions for
the training of health personnel, including
descriptions and analyses of student indebtedness,
student need for financial assistance, financial
resources to meet the needs of students, student career
choices such as practice specialty and geographic
location and the relationship, if any, between student
indebtedness and career choices.
(e) \1\ Requirements Regarding Personal Data.--
(1) In general.--The Secretary and each program
entity shall in securing and maintaining any record of
individually identifiable personal data (hereinafter in
this subsection referred to as ``personal data'') for
purposes of this section--
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\1\ So in law. Probably should be redesignated as (d).
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(A) inform any individual who is asked to
supply personal data whether he is legally
required, or may refuse, to supply such data
and inform him of any specific consequences,
known to the Secretary or program entity, as
the case may be, of providing or not providing
such data;
(B) upon request, inform any individual if
he is the subject of personal data secured or
maintained by the Secretary or program entity,
as the case may be, and make the data available
to him in a form comprehensible to him;
(C) assure that no use is made of personal
data which use is not within the purposes of
this section unless an informed consent has
been obtained from the individual who is the
subject of such data; and
(D) upon request, inform any individual of
the use being made of personal data respecting
such individual and of the identity of the
individuals and entities which will use the
data and their relationship to the programs
under this section.
(2) Consent as precondition to disclosure.--Any
entity which maintains a record of personal data and
which receives a request from the Secretary or a
program entity for such data for purposes of this
section shall not transfer any such data to the
Secretary or to a program entity unless the individual
whose personal data is to be so transferred gives an
informed consent for such transfer.
(3) Disclosure by secretary.--
(A) Notwithstanding any other provision of
law, personal data collected by the Secretary
or any program entity under this section may
not be made available or disclosed by the
Secretary or any program entity to any person
other than the individual who is the subject of
such data unless (i) such person requires such
data for purposes of this section, or (ii) in
response to a demand for such data made by
means of compulsory legal process. Any
individual who is the subject of personal data
made available or disclosed under clause (ii)
shall be notified of the demand for such data.
(B) Subject to all applicable laws
regarding confidentiality, only the data
collected by the Secretary under this section
which is not personal data shall be made
available to bona fide researchers and policy
analysts (including the Congress) for the
purposes of assisting in the conduct of studies
respecting health professions personnel.
(4) Definition.--For purposes of this subsection,
the term ``program entity'' means any public or private
entity which collects, compiles, or analyzes health
professions data under a grant, contract, or other
arrangement with the Secretary under this section.
(g) \1\ Technical Assistance.--The Secretary shall provide
technical assistance to the States and political subdivisions
thereof in the development of systems (including model laws)
concerning confidentiality and comparability of data collected
pursuant to this section.
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\1\ So in law. Probably should be redesignated as (e).
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(h) \2\ Grants and Contracts Regarding Nonprofit
Entities.--
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\2\ So in law. Probably should be redesignated as (f).
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(1) In general.--In carrying out subsection (a),
the Secretary may make grants, or enter into contracts
and cooperative agreements with, and provide technical
assistance to, any nonprofit entity in order to
establish a uniform allied health professions data
reporting system to collect, compile, and analyze data
on the allied health professions personnel.
(2) Reports.--With respect to reports required in
subsection (d), each such report made on or after
October 1, 1991, shall include a description and
analysis of data collected pursuant to paragraph (1).
SEC. 794. \3\ [295M] PROHIBITION AGAINST DISCRIMINATION ON BASIS OF
SEX.
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\3\ Section 793 was repealed by section 106(a)(2)(C) of Public Law
105-392 (112 Stat. 3557).
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The Secretary may not make a grant, loan guarantee, or
interest subsidy payment under this title to, or for the
benefit of, any school of medicine, osteopathic medicine,
dentistry, veterinary medicine, optometry, pharmacy, podiatric
medicine, or public health or any training center for allied
health personnel, or graduate program in clinical psychology,
unless the application for the grant, loan guarantee, or
interest subsidy payment contains assurances satisfactory to
the Secretary that the school or training center will not
discriminate on the basis of sex in the admission of
individuals to its training programs. The Secretary may not
enter into a contract under this title with any such school or
training center unless the school, training center, or graduate
program furnishes assurances satisfactory to the Secretary that
it will not discriminate on the basis of sex in the admission
of individuals to its training programs. In the case of a
school of medicine which--
(1) on the date of the enactment of this sentence
is in the process of changing its status as an
institution which admits only female students to that
of an institution which admits students without regard
to their sex, and
(2) is carrying out such change in accordance with
a plan approved by the Secretary,
the provisions of the preceding sentences of this section shall
apply only with respect to a grant, contract, loan guarantee,
or interest subsidy to, or for the benefit of such a school for
a fiscal year beginning after June 30, 1979.
SEC. 796. \1\ [295N-1] APPLICATION.
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\1\ Section 795 was repealed by section 101(b)(1) of Public Law
105-392 (112 Stat. 3537).
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(a) In General.--To be eligible to receive a grant or
contract under this title, an eligible entity shall prepare and
submit to the Secretary an application that meets the
requirements of this section, at such time, in such manner, and
containing such information as the Secretary may require.
(b) Plan.--An application submitted under this section
shall contain the plan of the applicant for carrying out a
project with amounts received under this title. Such plan shall
be consistent with relevant Federal, State, or regional health
professions program plans.
(c) Performance Outcome Standards.--An application
submitted under this section shall contain a specification by
the applicant entity of performance outcome standards that the
project to be funded under the grant or contract will be
measured against. Such standards shall address relevant health
workforce needs that the project will meet. The recipient of a
grant or contract under this section shall meet the standards
set forth in the grant or contract application.
(d) Linkages.--An application submitted under this section
shall contain a description of the linkages with relevant
educational and health care entities, including training
programs for other health professionals as appropriate, that
the project to be funded under the grant or contract will
establish. To the extent practicable, grantees under this
section shall establish linkages with health care providers who
provide care for underserved communities and populations.
SEC. 797. [295N-2] USE OF FUNDS.
(a) In General.--Amounts provided under a grant or contract
awarded under this title may be used for training program
development and support, faculty development, model
demonstrations, trainee support including tuition, books,
program fees and reasonable living expenses during the period
of training, technical assistance, workforce analysis,
dissemination of information, and exploring new policy
directions, as appropriate to meet recognized health workforce
objectives, in accordance with this title.
(b) Maintenance of Effort.--With respect to activities for
which a grant awarded under this title is to be expended, the
entity shall agree to maintain expenditures of non-Federal
amounts for such activities at a level that is not less than
the level of such expenditures maintained by the entity for the
fiscal year preceding the fiscal year for which the entity
receives such a grant.
SEC. 798. [295O] MATCHING REQUIREMENT.
The Secretary may require that an entity that applies for a
grant or contract under this title provide non-Federal matching
funds, as appropriate, to ensure the institutional commitment
of the entity to the projects funded under the grant. As
determined by the Secretary, such non-Federal matching funds
may be provided directly or through donations from public or
private entities and may be in cash or in-kind, fairly
evaluated, including plant, equipment, or services.
SEC. 799. [295O-1] GENERALLY APPLICABLE PROVISIONS.
(a) Awarding of Grants and Contracts.--The Secretary shall
ensure that grants and contracts under this title are awarded
on a competitive basis, as appropriate, to carry out innovative
demonstration projects or provide for strategic workforce
supplementation activities as needed to meet health workforce
goals and in accordance with this title. Contracts may be
entered into under this title with public or private entities
as may be necessary.
(b) Eligible Entities.--Unless specifically required
otherwise in this title, the Secretary shall accept
applications for grants or contracts under this title from
health professions schools, academic health centers, State or
local governments, or other appropriate public or private
nonprofit entities for funding and participation in health
professions and nursing training activities. The Secretary may
accept applications from for-profit private entities if
determined appropriate by the Secretary.
(c) Information Requirements.--
(1) In general.--Recipients of grants and contracts
under this title shall meet information requirements as
specified by the Secretary.
(2) Data collection.--The Secretary shall establish
procedures to ensure that, with respect to any data
collection required under this title, such data is
collected in a manner that takes into account age, sex,
race, and ethnicity.
(3) Use of funds.--The Secretary shall establish
procedures to permit the use of amounts appropriated
under this title to be used for data collection
purposes.
(4) Evaluations.--The Secretary shall establish
procedures to ensure the annual evaluation of programs
and projects operated by recipients of grants or
contracts under this title. Such procedures shall
ensure that continued funding for such programs and
projects will be conditioned upon a demonstration that
satisfactory progress has been made by the program or
project in meeting the objectives of the program or
project.
(d) Training Programs.--Training programs conducted with
amounts received under this title shall meet applicable
accreditation and quality standards.
(e) Duration of Assistance.--
(1) In general.--Subject to paragraph (2), in the
case of an award to an entity of a grant, cooperative
agreement, or contract under this title, the period
during which payments are made to the entity under the
award may not exceed 5 years. The provision of payments
under the award shall be subject to annual approval by
the Secretary of the payments and subject to the
availability of appropriations for the fiscal year
involved to make the payments. This paragraph may not
be construed as limiting the number of awards under the
program involved that may be made to the entity.
(2) Limitation.--In the case of an award to an
entity of a grant, cooperative agreement, or contract
under this title, paragraph (1) shall apply only to the
extent not inconsistent with any other provision of
this title that relates to the period during which
payments may be made under the award.
(f) Peer Review Regarding Certain Programs.--
(1) In general.--Each application for a grant under
this title, except any scholarship or loan program,
including those under sections \1\ 701, 721, or 723,
shall be submitted to a peer review group for an
evaluation of the merits of the proposals made in the
application. The Secretary may not approve such an
application unless a peer review group has recommended
the application for approval.
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\1\ So in law. Probably should read ``section''.
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(2) Composition.--Each peer review group under this
subsection shall be composed principally of individuals
who are not officers or employees of the Federal
Government. In providing for the establishment of peer
review groups and procedures, the Secretary shall
ensure sex, racial, ethnic, and geographic balance
among the membership of such groups.
(3) Administration.--This subsection shall be
carried out by the Secretary acting through the
Administrator of the Health Resources and Services
Administration.
(g) Preference or Priority Considerations.--In considering
a preference or priority for funding which is based on outcome
measures for an eligible entity under this title, the Secretary
may also consider the future ability of the eligible entity to
meet the outcome preference or priority through improvements in
the eligible entity's program design.
(h) Analytic Activities.--The Secretary shall ensure that--
(1) cross-cutting workforce analytical activities
are carried out as part of the workforce information
and analysis activities under section 761; and
(2) discipline-specific workforce information and
analytical activities are carried out as part of--
(A) the community-based linkage program
under part D; and
(B) the health workforce development
program under subpart 2 of part E.
(i) Osteopathic Schools.--For purposes of this title, any
reference to--
(1) medical schools shall include osteopathic
medical schools; and
(2) medical students shall include osteopathic
medical students.
SEC. 799A. [295O-2] TECHNICAL ASSISTANCE.
Funds appropriated under this title may be used by the
Secretary to provide technical assistance in relation to any of
the authorities under this title.
SEC. 799B. [295P] DEFINITIONS.
For purposes of this title:
(1)(A) The terms ``school of medicine'', ``school
of dentistry'', ``school of osteopathic medicine'',
``school of pharmacy'', ``school of optometry'',
``school of podiatric medicine'', ``school of
veterinary medicine'', ``school of public health'', and
``school of chiropractic'' mean an accredited public or
nonprofit private school in a State that provides
training leading, respectively, to a degree of doctor
of medicine, a degree of doctor of dentistry or an
equivalent degree, a degree of doctor of osteopathy, a
degree of bachelor of science in pharmacy or an
equivalent degree or a degree of doctor of pharmacy or
an equivalent degree, a degree of doctor of optometry
or an equivalent degree, a degree of doctor of
podiatric medicine or an equivalent degree, a degree of
doctor of veterinary medicine or an equivalent degree,
a graduate degree in public health or an equivalent
degree, and a degree of doctor of chiropractic or an
equivalent degree, and including advanced training
related to such training provided by any such school.
(B) The terms ``graduate program in health
administration'' and ``graduate program in clinical
psychology'' mean an accredited graduate program in a
public or nonprofit private institution in a State that
provides training leading, respectively, to a graduate
degree in health administration or an equivalent degree
and a doctoral degree in clinical psychology or an
equivalent degree.
(C) The terms ``graduate program in clinical social
work'' and ``graduate program in marriage and family
therapy'' and ``graduate program in professional
counseling'' mean an accredited graduate program in a
public or nonprofit private institution in a State that
provides training, respectively, in a concentration in
health or mental health care leading to a graduate
degree in social work and a concentration leading to a
graduate degree in marriage and family therapy and a
concentration leading to a graduate degree in
counseling.
(D) \1\ The term ``graduate program in behavioral
health and mental health practice'' means a graduate
program in clinical psychology, clinical social work,
professional counseling, or marriage and family
therapy.
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\1\ Section 108(a)(2) of Public Law 105-392 (112 Stat. 3560)
provides that paragraph (1)(D) is amended by inserting ``behavioral
health and mental health practice,'' before ``clinical''. The amendment
cannot be executed because the amendment does not specify to which
instance of the term ``clinical'' the amendment applies.
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(E) The term ``accredited'', when applied to a
school of medicine, osteopathic medicine, dentistry,
veterinary medicine, optometry, podiatry, pharmacy,
public health, or chiropractic, or a graduate program
in health administration, clinical psychology, clinical
social work, professional counseling, or marriage and
family therapy, means a school or program that is
accredited by a recognized body or bodies approved for
such purpose by the Secretary of Education, except that
a new school or program that, by reason of an
insufficient period of operation, is not, at the time
of application for a grant or contract under this
title, eligible for accreditation by such a recognized
body or bodies, shall be deemed accredited for purposes
of this title, if the Secretary of Education finds,
after consultation with the appropriate accreditation
body or bodies, that there is reasonable assurance that
the school or program will meet the accreditation
standards of such body or bodies prior to the beginning
of the academic year following the normal graduation
date of the first entering class in such school or
program.
(2) The term ``teaching facilities'' means areas
dedicated for use by students, faculty, or
administrative or maintenance personnel for clinical
purposes, research activities, libraries, classrooms,
offices, auditoriums, dining areas, student activities,
or other related purposes necessary for, and
appropriate to, the conduct of comprehensive programs
of education. Such term includes interim facilities but
does not include off-site improvements or living
quarters.
(3) Physician assistant education program.--The
term ``physician assistant education program'' means an
educational program in a public or private institution
in a State that--
(A) has as its objective the education of
individuals who, upon completion of their
studies in the program, be qualified to provide
primary care medical services with the
supervision of a physician; and
(B) is accredited by the Accreditation
Review Commission on Education for the
Physician Assistant.
(4) The term ``school of allied health'' means a
public or nonprofit private college, junior college, or
university or hospital-based educational entity that--
(A) provides, or can provide, programs of
education to enable individuals to become
allied health professionals or to provide
additional training for allied health
professionals;
(B) provides training for not less than a
total of twenty persons in the allied health
curricula (except that this subparagraph shall
not apply to any hospital-based educational
entity);
(C) includes or is affiliated with a
teaching hospital; and
(D) is accredited by a recognized body or
bodies approved for such purposes by the
Secretary of Education, or which provides to
the Secretary satisfactory assurance by such
accrediting body or bodies that reasonable
progress is being made toward accreditation.
(5) The term ``allied health professionals'' means
a health professional (other than a registered nurse or
physician assistant)--
(A) who has received a certificate, an
associate's degree, a bachelor's degree, a
master's degree, a doctoral degree, or
postbaccalaureate training, in a science
relating to health care;
(B) who shares in the responsibility for
the delivery of health care services or related
services, including--
(i) services relating to the
identification, evaluation, and
prevention of disease and disorders;
(ii) dietary and nutrition
services;
(iii) health promotion services;
(iv) rehabilitation services; or
(v) health systems management
services; and
(C) who has not received a degree of doctor
of medicine, a degree of doctor of osteopathy,
a degree of doctor of dentistry or an
equivalent degree, a degree of doctor of
veterinary medicine or an equivalent degree, a
degree of doctor of optometry or an equivalent
degree, a degree of doctor of podiatric
medicine or an equivalent degree, a degree of
bachelor of science in pharmacy or an
equivalent degree, a degree of doctor of
pharmacy or an equivalent degree, a graduate
degree in public health or an equivalent
degree, a degree of doctor of chiropractic or
an equivalent degree, a graduate degree in
health administration or an equivalent degree,
a doctoral degree in clinical psychology or an
equivalent degree, or a degree in social work
or an equivalent degree or a degree in
counseling or an equivalent degree.
(6) The term ``medically underserved community''
means an urban or rural area or population that--
(A) is eligible for designation under
section 332 as a health professional shortage
area;
(B) \1\ is eligible to be served by a
migrant health center under section 329, a
community health center under section 330, a
grantee under section 330(h) (relating to
homeless individuals), or a grantee under
section 340A (relating to residents of public
housing);
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\1\ See footnote for section 224(g)(1)(G)(ii).
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(C) has a shortage of personal health
services, as determined under criteria issued
by the Secretary under section 1861(aa)(2) of
the Social Security Act (relating to rural
health clinics); or
(D) is designated by a State Governor (in
consultation with the medical community) as a
shortage area or medically underserved
community.
(7) The term ``Department'' means the Department of
Health and Human Services.
(8) The term ``nonprofit'' refers to the status of
an entity owned and operated by one or more
corporations or associations no part of the net
earnings of which inures, or may lawfully inure, to the
benefit of any private shareholder or individual.
(9) The term ``State'' includes, in addition to the
several States, only the District of Columbia, the
Commonwealth of Puerto Rico, the Commonwealth of the
Northern Mariana Islands, the Virgin Islands, Guam,
American Samoa, and the Trust Territory of the Pacific
Islands.
(10)(A) Subject to subparagraph (B), the term
``underrepresented minorities'' means, with respect to
a health profession, racial and ethnic populations that
are underrepresented in the health profession relative
to the number of individuals who are members of the
population involved.
(B) For purposes of subparagraph (A), Asian
individuals shall be considered by the various
subpopulations of such individuals.
(11) The term ``psychologist'' means an individual
who--
(A) holds a doctoral degree in psychology;
and
(B) is licensed or certified on the basis
of the doctoral degree in psychology, by the
State in which the individual practices, at the
independent practice level of psychology to
furnish diagnostic, assessment, preventive, and
therapeutic services directly to individuals.
(12) Area health education center.--The term ``area
health education center'' means a public or nonprofit
private organization that has a cooperative agreement
or contract in effect with an entity that has received
an award under subsection (a)(1) or (a)(2) of section
751, satisfies the requirements in section 751(d)(1),
and has as one of its principal functions the operation
of an area health education center. Appropriate
organizations may include hospitals, health
organizations with accredited primary care training
programs, accredited physician assistant educational
programs associated with a college or university, and
universities or colleges not operating a school of
medicine or osteopathic medicine.
(13) Area health education center program.--The
term ``area health education center program'' means
cooperative program consisting of an entity that has
received an award under subsection (a)(1) or (a)(2) of
section 751 for the purpose of planning, developing,
operating, and evaluating an area health education
center program and one or more area health education
centers, which carries out the required activities
described in section 751(c), satisfies the program
requirements in such section, has as one of its
principal functions identifying and implementing
strategies and activities that address health care
workforce needs in its service area, in coordination
with the local workforce investment boards.
(14) Clinical social worker.--The term ``clinical
social worker'' has the meaning given the term in
section 1861(hh)(1) of the Social Security Act (42
U.S.C. 1395x(hh)(1)).
(15) Cultural competency.--The term ``cultural
competency'' shall be defined by the Secretary in a
manner consistent with section 1707(d)(3).
(16) Direct care worker.--The term ``direct care
worker'' has the meaning given that term in the 2010
Standard Occupational Classifications of the Department
of Labor for Home Health Aides [31-1011], Psychiatric
Aides [31-1013], Nursing Assistants [31-1014], and
Personal Care Aides [39-9021].
(17) Federally qualified health center.--The term
``Federally qualified health center'' has the meaning
given that term in section 1861(aa) of the Social
Security Act (42 U.S.C. 1395x(aa)).
(18) Frontier health professional shortage area.--
The term ``frontier health professional shortage area''
means an area--
(A) with a population density less than 6
persons per square mile within the service
area; and
(B) with respect to which the distance or
time for the population to access care is
excessive.
(19) Graduate psychology.--The term ``graduate
psychology'' means an accredited program in
professional psychology.
(20) Health disparity population.--The term
``health disparity population'' has the meaning given
such term in section 903(d)(1).
(21) Health literacy.--The term ``health literacy''
means the degree to which an individual has the
capacity to obtain, communicate, process, and
understand health information and services in order to
make appropriate health decisions.
(22) Mental health service professional.--The term
``mental health service professional'' means an
individual with a graduate or postgraduate degree from
an accredited institution of higher education in
psychiatry, psychology, school psychology, behavioral
pediatrics, psychiatric nursing, social work, school
social work, substance abuse disorder prevention and
treatment, marriage and family counseling, school
counseling, or professional counseling.
(23) One-stop delivery system center.--The term
``one-stop delivery system'' means a one-stop delivery
system described in section 134(c) of the Workforce
Investment Act of 1998 (29 U.S.C. 2864(c)).
(24) Paraprofessional child and adolescent mental
health worker.--The term ``paraprofessional child and
adolescent mental health worker'' means an individual
who is not a mental or behavioral health service
professional, but who works at the first stage of
contact with children and families who are seeking
mental or behavioral health services, including
substance abuse prevention and treatment services.
(25) Racial and ethnic minority group; racial and
ethnic minority population.--The terms ``racial and
ethnic minority group'' and ``racial and ethnic
minority population'' have the meaning given the term
`racial and ethnic minority group' in section 1707.
(26) Rural health clinic.--The term ``rural health
clinic'' has the meaning given that term in section
1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa)).ATTORNEY: PMG/FD (June 24,
1999) deg.
TITLE VIII--NURSING WORKFORCE DEVELOPMENT
PART A--GENERAL PROVISIONS
SEC. 801. [296] DEFINITIONS.
As used in this title:
(1) Eligible entities.--The term ``eligible
entities'' means schools of nursing, nursing centers,
academic health centers, State or local governments,
and other public or private nonprofit entities
determined appropriate by the Secretary that submit to
the Secretary an application in accordance with section
802.
(2) School of nursing.--The term ``school of
nursing'' means an accredited (as defined in paragraph
6) collegiate, associate degree, or diploma school of
nursing in a State where graduates are--
(A) authorized to sit for the National
Council Licensure EXamination-Registered Nurse
(NCLEX-RN); or
(B) licensed registered nurses who will
receive a graduate or equivalent degree or
training to become an advanced education nurse
as defined by section 811(b).
(3) Collegiate school of nursing.--The term
``collegiate school of nursing'' means a department,
division, or other administrative unit in a college or
university which provides primarily or exclusively a
program of education in professional nursing and
related subjects leading to the degree of bachelor of
arts, bachelor of science, bachelor of nursing, or to
an equivalent degree, or to a graduate degree in
nursing, or to an equivalent degree, and including
advanced training related to such program of education
provided by such school, but only if such program, or
such unit, college or university is accredited.
(4) Associate degree school of nursing.--The term
``associate degree school of nursing'' means a
department, division, or other administrative unit in a
junior college, community college, college, or
university which provides primarily or exclusively a
two-year program of education in professional nursing
and allied subjects leading to an associate degree in
nursing or to an equivalent degree, but only if such
program, or such unit, college, or university is
accredited.
(5) Diploma school of nursing.--The term ``diploma
school of nursing'' means a school affiliated with a
hospital or university, or an independent school, which
provides primarily or exclusively a program of
education in professional nursing and allied subjects
leading to a diploma or to equivalent indicia that such
program has been satisfactorily completed, but only if
such program, or such affiliated school or such
hospital or university or such independent school is
accredited.
(6) Accredited.--
(A) In general.--Except as provided in
subparagraph (B), the term ``accredited'' when
applied to any program of nurse education means
a program accredited by a recognized body or
bodies, or by a State agency, approved for such
purpose by the Secretary of Education and when
applied to a hospital, school, college, or
university (or a unit thereof) means a
hospital, school, college, or university (or a
unit thereof) which is accredited by a
recognized body or bodies, or by a State
agency, approved for such purpose by the
Secretary of Education. For the purpose of this
paragraph, the Secretary of Education shall
publish a list of recognized accrediting
bodies, and of State agencies, which the
Secretary of Education determines to be
reliable authority as to the quality of
education offered.
(B) New programs.--A new program of nursing
that, by reason of an insufficient period of
operation, is not, at the time of the
submission of an application for a grant or
contract under this title, eligible for
accreditation by such a recognized body or
bodies or State agency, shall be deemed
accredited for purposes of this title if the
Secretary of Education finds, after
consultation with the appropriate accreditation
body or bodies, that there is reasonable
assurance that the program will meet the
accreditation standards of such body or bodies
prior to the beginning of the academic year
following the normal graduation date of
students of the first entering class in such a
program.
(7) Nonprofit.--The term ``nonprofit'' as applied
to any school, agency, organization, or institution
means one which is a corporation or association, or is
owned and operated by one or more corporations or
associations, no part of the net earnings of which
inures, or may lawfully inure, to the benefit of any
private shareholder or individual.
(8) State.--The term ``State'' means a State, the
Commonwealth of Puerto Rico, the District of Columbia,
the Commonwealth of the Northern Mariana Islands, Guam,
American Samoa, the Virgin Islands, or the Trust
Territory of the Pacific Islands.
(9) Ambulatory surgical center.--The term
``ambulatory surgical center'' has the meaning
applicable to such term under title XVIII of the Social
Security Act.
(10) Federally qualified health center.--The term
``Federally qualified health center'' has the meaning
given such term under section 1861(aa)(4) of the Social
Security Act.
(11) Health care facility.--The term ``health care
facility'' means an Indian Health Service health
center, a Native Hawaiian health center, a hospital, a
Federally qualified health center, a rural health
clinic, a nursing home, a home health agency, a hospice
program, a public health clinic, a State or local
department of public health, a skilled nursing
facility, an ambulatory surgical center, or any other
facility designated by the Secretary.
(12) Home health agency.--The term ``home health
agency'' has the meaning given such term in section
1861(o) of the Social Security Act.
(13) Hospice program.--The term ``hospice program''
has the meaning given such term in section 1861(dd)(2)
of the Social Security Act.
(14) Rural health clinic.--The term ``rural health
clinic'' has the meaning given such term in section
1861(aa)(2) of the Social Security Act.
(15) Skilled nursing facility.--The term ``skilled
nursing facility'' has the meaning given such term in
section 1819(a) of the Social Security Act.
(16) Accelerated nursing degree program.--The term
``accelerated nursing degree program'' means a program
of education in professional nursing offered by an
accredited school of nursing in which an individual
holding a bachelors degree in another discipline
receives a BSN or MSN degree in an accelerated time
frame as determined by the accredited school of
nursing.
(17) Bridge or degree completion program.--The term
``bridge or degree completion program'' means a program
of education in professional nursing offered by an
accredited school of nursing, as defined in paragraph
(2), that leads to a baccalaureate degree in nursing.
Such programs may include, Registered Nurse (RN) to
Bachelor's of Science of Nursing (BSN) programs, RN to
MSN (Master of Science of Nursing) programs, or BSN to
Doctoral programs.
SEC. 802. [296A] APPLICATION.
(a) In General.--To be eligible to receive a grant or
contract under this title, an eligible entity shall prepare and
submit to the Secretary an application that meets the
requirements of this section, at such time, in such manner, and
containing such information as the Secretary may require.
(b) Plan.--An application submitted under this section
shall contain the plan of the applicant for carrying out a
project with amounts received under this title. Such plan shall
be consistent with relevant Federal, State, or regional program
plans.
(c) Performance Outcome Standards.--An application
submitted under this section shall contain a specification by
the applicant entity of performance outcome standards that the
project to be funded under the grant or contract will be
measured against. Such standards shall address relevant
national nursing needs that the project will meet. The
recipient of a grant or contract under this section shall meet
the standards set forth in the grant or contract application.
(d) Linkages.--An application submitted under this section
shall contain a description of the linkages with relevant
educational and health care entities, including training
programs for other health professionals as appropriate, that
the project to be funded under the grant or contract will
establish.
SEC. 803. [296B] USE OF FUNDS.
(a) In General.--Amounts provided under a grant or contract
awarded under this title may be used for training program
development and support, faculty development, model
demonstrations, trainee support including tuition, books,
program fees and reasonable living expenses during the period
of training, technical assistance, workforce analysis, and
dissemination of information, as appropriate to meet recognized
nursing objectives, in accordance with this title.
(b) Maintenance of Effort.--With respect to activities for
which a grant awarded under this title is to be expended, the
entity shall agree to maintain expenditures of non-Federal
amounts for such activities at a level that is not less than
the level of such expenditures maintained by the entity for the
fiscal year preceding the fiscal year for which the entity
receives such a grant.
SEC. 804. [296C] MATCHING REQUIREMENT.
The Secretary may require that an entity that applies for a
grant or contract under this title provide non-Federal matching
funds, as appropriate, to ensure the institutional commitment
of the entity to the projects funded under the grant. Such non-
Federal matching funds may be provided directly or through
donations from public or private entities and may be in cash or
in-kind, fairly evaluated, including plant, equipment, or
services.
SEC. 805. [296D] PREFERENCE.
In awarding grants or contracts under this title, the
Secretary shall give preference to applicants with projects
that will substantially benefit rural or underserved
populations, or help meet public health nursing needs in State
or local health departments.
SEC. 806. [296E] GENERALLY APPLICABLE PROVISIONS.
(a) Awarding of Grants and Contracts.--The Secretary shall
ensure that grants and contracts under this title are awarded
on a competitive basis, as appropriate, to carry out innovative
demonstration projects or provide for strategic workforce
supplementation activities as needed to meet national nursing
service goals and in accordance with this title. Contracts may
be entered into under this title with public or private
entities as determined necessary by the Secretary.
(b) Information Requirements.--
(1) In general.--Recipients of grants and contracts
under this title shall meet information requirements as
specified by the Secretary.
(2) Evaluations.--The Secretary shall establish
procedures to ensure the annual evaluation of programs
and projects operated by recipients of grants under
this title. Such procedures shall ensure that continued
funding for such programs and projects will be
conditioned upon a demonstration that satisfactory
progress has been made by the program or project in
meeting the objectives of the program or project.
(c) Training Programs.--Training programs conducted with
amounts received under this title shall meet applicable
accreditation and quality standards.
(d) Duration of Assistance.--
(1) In general.--Subject to paragraph (2), in the
case of an award to an entity of a grant, cooperative
agreement, or contract under this title, the period
during which payments are made to the entity under the
award may not exceed 5 years. The provision of payments
under the award shall be subject to annual approval by
the Secretary of the payments and subject to the
availability of appropriations for the fiscal year
involved to make the payments. This paragraph may not
be construed as limiting the number of awards under the
program involved that may be made to the entity.
(2) Limitation.--In the case of an award to an
entity of a grant, cooperative agreement, or contract
under this title, paragraph (1) shall apply only to the
extent not inconsistent with any other provision of
this title that relates to the period during which
payments may be made under the award.
(e) Peer Review Regarding Certain Programs.--
(1) In general.--Each application for a grant under
this title, except advanced nurse traineeship grants
under section 811(a)(2), shall be submitted to a peer
review group for an evaluation of the merits of the
proposals made in the application. The Secretary may
not approve such an application unless a peer review
group has recommended the application for approval.
(2) Composition.--Each peer review group under this
subsection shall be composed principally of individuals
who are not officers or employees of the Federal
Government. In providing for the establishment of peer
review groups and procedures, the Secretary shall,
except as otherwise provided, ensure sex, racial,
ethnic, and geographic representation among the
membership of such groups.
(3) Administration.--This subsection shall be
carried out by the Secretary acting through the
Administrator of the Health Resources and Services
Administration.
(f) Analytic Activities.--The Secretary shall ensure that--
(1) cross-cutting workforce analytical activities
are carried out as part of the workforce information
and analysis activities under this title; and
(2) discipline-specific workforce information is
developed and analytical activities are carried out as
part of--
(A) the advanced education nursing
activities under part B;
(B) the workforce diversity activities
under part C; and
(C) basic nursing education and practice
activities under part D.
(g) State and Regional Priorities.--Activities under grants
or contracts under this title shall, to the extent practicable,
be consistent with related Federal, State, or regional nursing
professions program plans and priorities.
(h) Filing of Applications.--
(1) In general.--Applications for grants or
contracts under this title may be submitted by health
professions schools, schools of nursing, academic
health centers, State or local governments, or other
appropriate public or private nonprofit entities as
determined appropriate by the Secretary in accordance
with this title.
(2) For-profit entities.--Notwithstanding paragraph
(1), a for-profit entity may be eligible for a grant or
contract under this title as determined appropriate by
the Secretary.
SEC. 807. [296E-1] GRANTS FOR HEALTH PROFESSIONS EDUCATION.
(a) Cultural Competency, Prevention, and Public Health and
Individuals With Disability Grants.--The Secretary, acting
through the Administrator of the Health Resources and Services
Administration, may make awards of grants, contracts, or
cooperative agreements to eligible entities for the
development, evaluation, and dissemination of research,
demonstration projects, and model curricula for cultural
competency, prevention, public health proficiency, reducing
health disparities, and aptitude for working with individuals
with disabilities training for use in health professions
schools and continuing education programs, and for other
purposes determined as appropriate by the Secretary. Grants
under this section shall be the same as provided in section
741.
(b) Collaboration.--In carrying out subsection (a), the
Secretary shall collaborate with the entities described in
section 741(b). The Secretary shall coordinate with curricula
and research and demonstration projects developed under such
section 741.
(c) Dissemination.--Model curricula developed under this
section shall be disseminated and evaluated in the same manner
as model curricula developed under section 741, as described in
subsection (c) of such section.
(d) Authorization of Appropriations.--There are to be
appropriated to carry out this section such sums as may be
necessary for each of the fiscal years 2010 through 2015.
SEC. 808. [296F] TECHNICAL ASSISTANCE.
Funds appropriated under this title may be used by the
Secretary to provide technical assistance in relation to any of
the authorities under this title.
prohibition against discrimination by schools on the basis of sex
Sec. 809. [296g] The Secretary may not make a grant, loan
guarantee, or interest subsidy payment under this title to, or
for the benefit of, any school of nursing unless the
application for the grant, loan guarantee, or interest subsidy
payment contains assurances satisfactory to the Secretary that
the school will not discriminate on the basis of sex in the
admission of individuals to its training programs. The
Secretary may not enter into a contract under this title with
any school unless the school furnishes assurances satisfactory
to the Secretary that it will not discriminate on the basis of
sex in the admission of individuals to its training programs.
PART B--NURSE PRACTITIONERS, NURSE MIDWIVES, NURSE ANESTHETISTS, AND
OTHER ADVANCED EDUCATION NURSES
SEC. 811. [296J] ADVANCED EDUCATION NURSING GRANTS.
(a) In General.--The Secretary may award grants to and
enter into contracts with eligible entities to meet the costs
of--
(1) projects that support the enhancement of
advanced nursing education and practice; and
(2) traineeships for individuals in advanced
nursing education programs.
(b) Definition of Advanced Education Nurses.--For purposes
of this section, the term ``advanced education nurses'' means
individuals trained in advanced degree programs including
individuals in combined R.N./Master's degree programs, post-
nursing master's certificate programs, or, in the case of nurse
midwives, in certificate programs in existence on the date that
is one day prior to the date of enactment of this section, to
serve as nurse practitioners, clinical nurse specialists, nurse
midwives, nurse anesthetists, nurse educators, nurse
administrators, or public health nurses, or in other nurse
specialties determined by the Secretary to require advanced
education.
(c) Authorized Nurse Practitioner.--Nurse practitioner
programs eligible for support under this section are
educational programs for registered nurses (irrespective of the
type of school of nursing in which the nurses received their
training) that--
(1) meet guidelines prescribed by the Secretary;
and
(2) have as their objective the education of nurses
who will upon completion of their studies in such
programs, be qualified to effectively provide primary
health care, including primary health care in homes and
in ambulatory care facilities, long-term care
facilities, acute care, and other health care settings.
(d) Authorized Nurse-midwifery Programs.--Midwifery
programs that are eligible for support under this section are
educational programs that--
(1) have as their objective the education of
midwives; and
(2) are accredited by the American College of
Nurse-Midwives Accreditation Commission for Midwifery
Education.
(e) Authorized Nurse Anesthesia Programs.--Nurse anesthesia
programs eligible for support under this section are education
programs that--
(1) provide registered nurses with full-time
anesthetist education; and
(2) are accredited by the Council on Accreditation
of Nurse Anesthesia Educational Programs.
(f) Other Authorized Educational Programs.--The Secretary
shall prescribe guidelines as appropriate for other advanced
nurse education programs eligible for support under this
section.
(g) Traineeships.--
(1) In general.--The Secretary may not award a
grant to an applicant under subsection (a) unless the
applicant involved agrees that traineeships provided
with the grant will only pay all or part of the costs
of--
(A) the tuition, books, and fees of the
program of advanced nurse education with
respect to which the traineeship is provided;
and
(B) the reasonable living expenses of the
individual during the period for which the
traineeship is provided.
(2) Special consideration.--In making awards of
grants and contracts under subsection (a)(2), the
Secretary shall give special consideration to an
eligible entity that agrees to expend the award to
train advanced education nurses who will practice in
health professional shortage areas designated under
section 332.
PART C--INCREASING NURSING WORKFORCE DIVERSITY
SEC. 821. [296M] WORKFORCE DIVERSITY GRANTS.
(a) \1\ In General.--
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\1\ So in law. There is no paragraph (2) in subsection (a).
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(1) Authority.--The Secretary may award grants to
and enter into contracts with eligible entities to meet
the costs of special projects to increase nursing
education opportunities for individuals who are from
disadvantaged backgrounds (including racial and ethnic
minorities underrepresented among registered nurses) by
providing student scholarships or stipends, stipends
for diploma or associate degree nurses to enter a
bridge or degree completion program, student
scholarships or stipends for accelerated nursing degree
programs, pre-entry preparation, advanced education
preparation, and retention activities.
(b) Guidance.--In carrying out subsection (a), the
Secretary shall take into consideration the recommendations of
the National Advisory Council on Nurse Education and Practice
and consult with nursing associations including the National
Coalition of Ethnic Minority Nurse Associations, American
Nurses Association, the National League for Nursing, the
American Association of Colleges of Nursing, the National Black
Nurses Association, the National Association of Hispanic
Nurses, the Association of Asian American and Pacific Islander
Nurses, the Native American Indian and Alaskan Nurses
Association, and the National Council of State Boards of
Nursing, and other organizations determined appropriate by the
Secretary.
(c) Required Information and Conditions for Award
Recipients.--
(1) In general.--Recipients of awards under this
section may be required, where requested, to report to
the Secretary concerning the annual admission,
retention, and graduation rates for individuals from
disadvantaged backgrounds and ethnic and racial
minorities in the school or schools involved in the
projects.
(2) Falling rates.--If any of the rates reported
under paragraph (1) fall below the average of the two
previous years, the grant or contract recipient shall
provide the Secretary with plans for immediately
improving such rates.
(3) Ineligibility.--A recipient described in
paragraph (2) shall be ineligible for continued funding
under this section if the plan of the recipient fails
to improve the rates within the 1-year period beginning
on the date such plan is implemented.
PART D--STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
SEC. 831. [296P] NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
(a) Education Priority Areas.--The Secretary may award
grants to or enter into contracts with eligible entities for--
(1) expanding the enrollment in baccalaureate
nursing programs; or
(2) providing education in new technologies,
including distance learning methodologies.
(b) Practice Priority Areas.--The Secretary may award
grants to or enter into contracts with eligible entities for--
(1) establishing or expanding nursing practice
arrangements in noninstitutional settings to
demonstrate methods to improve access to primary health
care in medically underserved communities;
(2) providing care for underserved populations and
other high-risk groups such as the elderly, individuals
with HIV/AIDS, substance abusers, the homeless, and
victims of domestic violence;
(3) providing coordinated care, and other skills
needed to practice in existing and emerging organized
health care systems; or
(4) developing cultural competencies among nurses.
(c) Retention Priority Areas.--The Secretary may award
grants to and enter into contracts with eligible entities to
enhance the nursing workforce by initiating and maintaining
nurse retention programs pursuant to paragraph (1) or (2).
(1) Grants for career ladder programs.--The
Secretary may award grants to and enter into contracts
with eligible entities for programs--
(A) to promote career advancement for
nursing personnel in a variety of training
settings, cross training or specialty training
among diverse population groups, and the
advancement of individuals including to become
professional nurses, advanced education nurses,
licensed practical nurses, certified nurse
assistants, and home health aides; and
(B) to assist individuals in obtaining
education and training required to enter the
nursing profession and advance within such
profession, such as by providing career
counseling and mentoring.
(2) Enhancing patient care delivery systems.--
(A) Grants.--The Secretary may award grants
to eligible entities to improve the retention
of nurses and enhance patient care that is
directly related to nursing activities by
enhancing collaboration and communication among
nurses and other health care professionals, and
by promoting nurse involvement in the
organizational and clinical decisionmaking
processes of a health care facility.
(B) Preference.--In making awards of grants
under this paragraph, the Secretary shall give
a preference to applicants that have not
previously received an award under this
paragraph.
(C) Continuation of an award.--The
Secretary shall make continuation of any award
under this paragraph beyond the second year of
such award contingent on the recipient of such
award having demonstrated to the Secretary
measurable and substantive improvement in nurse
retention or patient care.
(d) Other Priority Areas.--The Secretary may award grants
to or enter into contracts with eligible entities to address
other areas that are of high priority to nurse education,
practice, and retention, as determined by the Secretary.
(e) Preference.--For purposes of any amount of funds
appropriated to carry out this section for fiscal year 2003,
2004, or 2005 that is in excess of the amount of funds
appropriated to carry out this section for fiscal year 2002,
the Secretary shall give preference to awarding grants or
entering into contracts under subsections (a)(2) and (c).
(f) Report.--The Secretary shall submit to the Congress
before the end of each fiscal year a report on the grants
awarded and the contracts entered into under this section. Each
such report shall identify the overall number of such grants
and contracts and provide an explanation of why each such grant
or contract will meet the priority need of the nursing
workforce.
(g) Eligible Entity.--For purposes of this section, the
term ``eligible entity'' includes a school of nursing, as
defined in section 801(2),, \1\ a health care facility, or a
partnership of such a school and facility.
---------------------------------------------------------------------------
\1\ So in law.
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(h) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2014.
SEC. 831A. [296P-1] NURSE RETENTION GRANTS.
(a) Retention Priority Areas.--The Secretary may award
grants to, and enter into contracts with, eligible entities to
enhance the nursing workforce by initiating and maintaining
nurse retention programs pursuant to subsection (b) or (c).
(b) Grants for Career Ladder Program.--The Secretary may
award grants to, and enter into contracts with, eligible
entities for programs--
(1) to promote career advancement for individuals
including licensed practical nurses, licensed
vocational nurses, certified nurse assistants, home
health aides, diploma degree or associate degree
nurses, to become baccalaureate prepared registered
nurses or advanced education nurses in order to meet
the needs of the registered nurse workforce;
(2) developing and implementing internships and
residency programs in collaboration with an accredited
school of nursing, as defined by section 801(2), to
encourage mentoring and the development of specialties;
or
(3) to assist individuals in obtaining education
and training required to enter the nursing profession
and advance within such profession.
(c) Enhancing Patient Care Delivery Systems.--
(1) Grants.--The Secretary may award grants to
eligible entities to improve the retention of nurses
and enhance patient care that is directly related to
nursing activities by enhancing collaboration and
communication among nurses and other health care
professionals, and by promoting nurse involvement in
the organizational and clinical decision-making
processes of a health care facility.
(2) Priority.--In making awards of grants under
this subsection, the Secretary shall give preference to
applicants that have not previously received an award
under this subsection (or section 831(c) as such
section existed on the day before the date of enactment
of this section).
(3) Continuation of an award.--The Secretary shall
make continuation of any award under this subsection
beyond the second year of such award contingent on the
recipient of such award having demonstrated to the
Secretary measurable and substantive improvement in
nurse retention or patient care.
(d) Other Priority Areas.--The Secretary may award grants
to, or enter into contracts with, eligible entities to address
other areas that are of high priority to nurse retention, as
determined by the Secretary.
(e) Report.--The Secretary shall submit to the Congress
before the end of each fiscal year a report on the grants
awarded and the contracts entered into under this section. Each
such report shall identify the overall number of such grants
and contracts and provide an explanation of why each such grant
or contract will meet the priority need of the nursing
workforce.
(f) Eligible Entity.--For purposes of this section, the
term ``eligible entity'' includes an accredited school of
nursing, as defined by section 801(2), a health care facility,
or a partnership of such a school and facility.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2012.
PART E--STUDENT LOANS 1
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\1\ Section 936(e) of Public Law 94-63 repealed a section of this
title that provided for a revolving fund. This former section was
section 827. With respect to the revolving fund, such section 936(e)
provided as follows: ``The nurse training fund created within the
Treasury by section 827(d)(1) of the Act shall remain available to the
Secretary of Health, Education, and Welfare for the purpose of meeting
his responsibilities respecting participations in obligations acquired
under section 827 of the Act. The Secretary shall continue to deposit
in such fund all amounts received by him as interest payments or
repayments of principal on loans under such section 827. If at any time
the Secretary determines the moneys in the funds exceed the present and
any reasonable prospective further requirements of such fund, such
excess may be transferred to the general fund of the Treasury.''. Such
section further provided that ``[t]here are authorized to be
appropriated without fiscal year limitation such sums as may be
necessary to enable the Secretary to make payments under agreements
entered into under section 827(b) of the Act before [July 27, 1975]''.
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loan agreements
Sec. 835. [297a] (a) The Secretary is authorized to enter
into an agreement for the establishment and operation of a
student loan fund in accordance with this part with any public
or nonprofit private school of nursing which is located in a
State.
(b) Each agreement entered into under this section shall--
(1) provide for establishment of a student loan
fund by the school;
(2) provide for deposit in the fund, except as
provided in section 871, of (A) the Federal capital
contributions paid from allotments under section 838 to
the school by the Secretary, (B) an additional amount
from other sources equal to not less than one-ninth of
such Federal capital contributions, (C) collections of
principal and interest on loans made from the fund, (D)
collections pursuant to section 836(f), and (E) any
other earnings of the fund;
(3) provide that the fund, except as provided in
section 871, shall be used only for loans to students
of the school in accordance with the agreement and for
costs of collection of such loans and interest thereon;
(4) provide that loans may be made from such fund
only to students pursuing a full-time or half-time
course of study at the school leading to a
baccalaureate or associate degree in nursing or an
equivalent degree or a diploma in nursing, or to a
graduate degree in nursing; and
(5) contain such other provisions as are necessary
to protect the financial interests of the United
States.
(c)(1) Any standard established by the Secretary by
regulation for the collection by schools of nursing of loans
made pursuant to loan agreements under this part shall provide
that the failure of any such school to collect such loans shall
be measured in accordance with this subsection. With respect to
the student loan fund established pursuant to such agreements,
this subsection may not be construed to require such schools to
reimburse such loan fund for loans that became uncollectable
prior to 1983.
(2) The measurement of a school's failure to collect
loans made under this part shall be the ratio (stated as a
percentage) that the defaulted principal amount outstanding of
such school bears to the matured loans of such school.
(3) For purposes of this subsection--
(A) the term ``default'' means the failure of a
borrower of a loan made under this part to--
(i) make an installment payment when due;
or
(ii) comply with any other term of the
promissory note for such loan,
except that a loan made under this part shall not be
considered to be in default if the loan is discharged
in bankruptcy or if the school reasonably concludes
from written contacts with the borrower that the
borrower intends to repay the loan;
(B) the term ``defaulted principal amount
outstanding'' means the total amount borrowed from the
loan fund of a school that has reached the repayment
stage (minus any principal amount repaid or cancelled)
on loans--
(i) repayable monthly and in default for at
least 120 days; and
(ii) repayable less frequently than monthly
and in default for at least 180 days;
(C) the term ``grace period'' means the period of
nine months beginning on the date on which the borrower
ceases to pursue a full-time or half-time course of
study at a school of nursing; and
(D) the term ``matured loans'' means the total
principal amount of all loans made by a school of
nursing under this part minus the total principal
amount of loans made by such school to students who
are--
(i) enrolled in a full-time or half-time
course of study at such school; or
(ii) in their grace period.
loan provisions
Sec. 836. [297b] (a) The total of the loans for any
academic year (or its equivalent, as determined under
regulations of the Secretary) made by schools of nursing from
loan funds established pursuant to agreements under this part
may not exceed $3,300 in the case of any student, except that
for the final two academic years of the program involved, such
total may not exceed $5,200. The aggregate of the loans for all
years from such funds may not exceed $17,000 in the case of any
student during fiscal years 2010 and 2011. After fiscal year
2011, such amounts shall be adjusted to provide for a cost-of-
attendance increase for the yearly loan rate and the aggregate
of the loans.
(b) Loans from any such student loan fund by any school
shall be made on such terms and conditions as the school may
determine; subject, however, to such conditions, limitations,
and requirements as the Secretary may prescribe (by regulation
or in the agreement with the school) with a view to preventing
impairment of the capital of such fund to the maximum extent
practicable in the light of the objective of enabling the
student to complete his course of study; and except that--
(1) such a loan may be made only to a student who
(A) is in need of the amount of the loan to pursue a
full-time or half-time course of study at the school
leading to a baccalaureate or associate degree in
nursing or an equivalent degree, or a diploma in
nursing, or a graduate degree in nursing, (B) is
capable, in the opinion of the school, of maintaining
good standing in such course of study, and (C) with
respect to any student enrolling in the school after
June 30, 2000, is of financial need (as defined in
regulations issued by the Secretary);
(2) such a loan shall be repayable in equal or
graduated periodic installments (with the right of the
borrower to accelerate repayment) over the ten-year
period which begins nine months after the student
ceases to pursue a full-time or half-time course of
study at a school of nursing, excluding from such 10-
year period all (A) periods (up to three years) of (i)
active duty performed by the borrower as a member of a
uniformed service, or (ii) service as a volunteer under
the Peace Corps Act, (B) periods (up to ten years)
during which the borrower is pursuing a full-time or
half-time course of study at a collegiate school of
nursing leading to baccalaureate degree in nursing or
an equivalent degree, or to graduate degree in nursing,
or is otherwise pursuing advanced professional training
in nursing (or training to be a nurse anesthetist), and
(C) such additional periods under the terms of
paragraph (8) of this subsection;
(3) in the case of a student who received such a
loan before September 29, 1995, an amount up to 85 per
centum of any such loan made before such date (plus
interest thereon) shall be canceled for full-time
employment as a professional nurse (including teaching
in any of the fields of nurse training and service as
an administrator, supervisor, or consultant in any of
the fields of nursing) in any public or nonprofit
private agency, institution, or organization (including
neighborhood health centers), at the rate of 15 per
centum of the amount of such loan (plus interest)
unpaid on the first day of such service for each of the
first, second, and third complete year of such service,
and 20 per centum of such amount (plus interest) for
each complete fourth and fifth year of such service;
(4) the liability to repay the unpaid balance of
such loan and accrued interest thereon shall be
canceled upon the death of the borrower, or if the
Secretary determines that he has become permanently and
totally disabled;
(5) such a loan shall bear interest on the unpaid
balance of the loan, computed only for periods during
which the loan is repayable, at the rate of 5 percent
per annum;
(6) such a loan shall be made without security or
endorsement, except that if the borrower is a minor and
the note or other evidence of obligation executed by
him would not, under the applicable law, create a
binding obligation, either security or endorsement may
be required;
(7) no note or other evidence of any such loan may
be transferred or assigned by the school making the
loan except that, if the borrower transfers to another
school participating in the program under this part,
such note or other evidence of a loan may be
transferred to such other school; and
(8) pursuant to uniform criteria established by the
Secretary, the repayment period established under
paragraph (2) for any student borrower who during the
repayment period failed to make consecutive payments
and who, during the last 12 months of the repayment
period, has made at least 12 consecutive payments may
be extended for a period not to exceed 10 years.
(c) Where all or any part of a loan, or interest, is
canceled under this section, the Secretary shall pay to the
school an amount equal to the school's proportionate share of
the canceled portion, as determined by the Secretary.
(d) Any loan for any year by a school from a student loan
fund established pursuant to an agreement under this part shall
be made in such installments as may be provided in regulations
of the Secretary or such agreement and, upon notice to the
Secretary by the school that any recipient of a loan is failing
to maintain satisfactory standing, any or all further
installments of his loans shall be withheld, as may be
appropriate.
(e) An agreement under this part with any school shall
include provisions designed to make loans from the student loan
fund established thereunder reasonably available (to the extent
of the available funds in such fund) to all eligible students
in the school in need thereof.
(f) Subject to regulations of the Secretary and in
accordance with this section, a school shall assess a charge
with respect to a loan from the loan fund established pursuant
to an agreement under this part for failure of the borrower to
pay all or any part of an installment when it is due and, in
the case of a borrower who is entitled to deferment of the loan
under subsection (b)(2) or cancellation of part or all of the
loan under subsection (b)(3), for any failure to file timely
and satisfactory evidence of such entitlement. No such charge
may be made if the payment of such installment or the filing of
such evidence is made within 60 days after the date on which
such installment or filing is due. The amount of any such
charge may not exceed an amount equal to 6 percent of the
amount of such installment. The school may elect to add the
amount of any such charge to the principal amount of the loan
as of the first day after the day on which such installment or
evidence was due, or to make the amount of the charge payable
to the school not later than the due date of the next
installment after receipt by the borrower of notice of the
assessment of the charge.
(g) A school may provide in accordance with regulations of
the Secretary, that during the repayment period of a loan from
a loan fund established pursuant to an agreement under this
part payments of principal and interest by the borrower with
respect to all the outstanding loans made to him from loan
funds so established shall be at a rate equal to not less than
$40 per month.
(h) Notwithstanding the amendment made by section 6(b) of
the Nurse Training Act of 1971 to this section--
(A) any person who obtained one or more loans from
a loan fund established under this part, who before the
date of the enactment of the Nurse Training Act of 1971
became eligible for cancellation of all or part of such
loans (including accrued interest) under this section
(as in effect on the day before such date), and who on
such date was not engaged in a service for which loan
cancellation was authorized under this section (as so
in effect), may at any time elect to receive such
cancellation in accordance with this subsection (as so
in effect); and
(B) in the case of any person who obtained one or
more loans from a loan fund established under this part
and who on such date was engaged in a service for which
cancellation of all or part of such loans (including
accrued interest) was authorized under this section (as
so in effect), this section (as so in effect) shall
continue to apply to such person for purposes of
providing such loan cancellation until he terminates
such service.
(i) Upon application by a person who received and is under
an obligation to repay, any loan made to such person as a
nursing student, the Secretary may undertake to repay (without
liability to the applicant) all or any part of such loan, and
any interest or portion thereof outstanding thereon, upon his
determination, pursuant to regulations establishing criteria
therefor, that the applicant--
(1) failed to complete the nursing studies with
respect to which such loan was made;
(2) is in exceptionally needy circumstances; and
(3) has not resumed, or cannot reasonably be
expected to resume, such nursing studies within two
years following the date upon which the applicant
terminated the studies with respect to which such loan
was made.
(j) The Secretary is authorized to attempt to collect any
loan which was made under this part, which is in default, and
which was referred to the Secretary by a school of nursing with
which the Secretary has an agreement under this part, on behalf
of that school under such terms and conditions as the Secretary
may prescribe (including reimbursement from the school's
student loan fund for expenses the Secretary may reasonably
incur in attempting collection), but only if the school has
complied with such requirements as the Secretary may specify by
regulation with respect to the collection of loans under this
part. A loan so referred shall be treated as a debt subject to
section 5514 of title 5, United States Code. Amounts collected
shall be deposited in the school's student loan fund. Whenever
the Secretary desires the institution of a civil action
regarding any such loan, the Secretary shall refer the matter
to the Attorney General for appropriate action.
(k) \3\ Elimination of Statute of Limitation for Loan
Collections.--
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\3\ Paragraph (2) of section 133(c) of Public Law 105-392 provides
as follows: ``The amendment made by paragraph (1) shall be effective
with respect to actions pending on or after the date of enactment of
this Act.''.
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(1) Purpose.--It is the purpose of this subsection
to ensure that obligations to repay loans under this
section are enforced without regard to any Federal or
State statutory, regulatory, or administrative
limitation on the period within which debts may be
enforced.
(2) Prohibition.--Notwithstanding any other
provision of Federal or State law, no limitation shall
terminate the period within which suit may be filed, a
judgment may be enforced, or an offset, garnishment, or
other action may be initiated or taken by a school of
nursing that has an agreement with the Secretary
pursuant to section 835 that is seeking the repayment
of the amount due from a borrower on a loan made under
this part after the default of the borrower on such
loan.
allotments and payments of federal capital contributions
Sec. 838. \2\ [297d] (a)(1) The Secretary shall from time
to time set dates by which schools of nursing in a State must
file applications for Federal capital contributions.
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\2\ Section 837 was repealed by section 123(3) of Public Law 105-
392 (112 Stat. 3562).
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(2)(A) If the total of the amounts requested for any fiscal
year in such applications exceeds the total amount appropriated
under section 837 \2\ for that fiscal year, the allotment from
such total amount to the loan fund of each school of nursing
shall be reduced to whichever of the following is the smaller:
(i) The amount requested in its application.
(ii) An amount which bears the same ratio to the
total amount appropriated as the number of students
estimated by the Secretary to be enrolled on a full-
time basis in such school during such fiscal year bears
to the estimated total number of students enrolled in
all such schools on a full-time basis during such year.
(B) Amounts remaining after allotment under subparagraph
(A) shall be reallotted in accordance with clause (ii) of such
subparagraph among schools whose applications requested more
than the amounts so allotted to their loan funds, but with such
adjustments as may be necessary to prevent the total allotted
to any such school's loan fund under this paragraph and
paragraph (3) from exceeding the total so requested by it.
(3) Funds which, pursuant to section 839(c) or pursuant
to a loan agreement under section 835, are returned to the
Secretary in any fiscal year, shall be available for allotment
until expended. Funds described in the preceding sentence shall
be allotted among schools of nursing in such manner as the
Secretary determines will best carry out this part.
(b) Allotments to a loan fund of a school shall be paid
to it from time to time in such installments as the Secretary
determines will not result in unnecessary accumulations in the
loan fund at such school.
(c) The Federal capital contributions to a loan fund of a
school under this part shall be paid to it from time to time in
such installments as the Secretary determines will not result
in unnecessary accumulations in the loan fund at such school.
distribution of assets from loan funds
Sec. 839. [297e] (a) If a school terminates a loan fund
established under an agreement pursuant to section 835(b), or
if the Secretary for good cause terminates the agreement with
the school, there shall be a capital distribution as follows:
(1) The Secretary shall first be paid an amount
which bears the same ratio to such balance in such fund
on the date of termination of the fund as the total
amount of the Federal capital contributions to such
fund by the Secretary pursuant to section 835(b)(2)(A)
bears to the total amount in such fund derived from
such Federal capital contributions and from funds
deposited therein pursuant to section 835(b)(2)(B).
(2) The remainder of such balance shall be paid to
the school.
(b) If a capital distribution is made under subsection (a),
the school involved shall, after such capital distribution, pay
to the Secretary, not less often than quarterly, the same
proportionate share of amounts received by the school in
payment of principal or interest on loans made from the loan
fund established under section 835(b) as determined by the
Secretary under subsection (a).
(c)(1) Within 90 days after the termination of any
agreement with a school under section 835 or the termination in
any other manner of a school's participation in the loan
program under this subpart \1\, such school shall pay to the
Secretary from the balance of the loan fund of such school
established under section 835, an amount which bears the same
ratio to the balance in such fund on the date of such
termination as the total amount of the Federal capital
contributions to such fund by the Secretary pursuant to section
835(b)(2)(A) bears to the total amount in such fund on such
date derived from such Federal capital contributions and from
funds deposited in the fund pursuant to section 835(b)(2)(B).
The remainder of such balance shall be paid to the school.
---------------------------------------------------------------------------
\1\ So in law. Probably should read ``part''.
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(2) A school to which paragraph (1) applies shall pay to
the Secretary after the date on which payment is made under
such paragraph and not less than quarterly, the same
proportionate share of amounts received by the school after the
date of termination referred to in paragraph (1) in payment of
principal or interest on loans made from the loan fund as was
determined for the Secretary under such
paragraph.These sections appeared in subpart II of
Part B. Do they stay? If so the sequence of sections are not
right. deg.
administrative provisions
Sec. 840. [297g] The Secretary may agree to modifications
of agreements made under this part, and may compromise, waive,
or release any right, title, claim, or demand of the United
States arising or acquired under this part.
procedures for appeal of terminations
Sec. 842. \2\ [297i] In any case in which the Secretary
intends to terminate an agreement with a school of nursing
under this part, the Secretary shall provide the school with a
written notice specifying such intention and stating that the
school may request a formal hearing with respect to such
termination. If the school requests such a hearing within 30
days after the receipt of such notice, the Secretary shall
provide such school with a hearing conducted by an
administrative law judge.
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\2\ There is no section 841 between sections 840 and 842. Section
5310(b)(7) of Public Law 111-148 redesignates section 841 as section
871. Such amendment also redesignates part F as part I and transfers
part I (as redesignated) to the end of this title.
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loan repayment and scholarship programs
Sec. 846. \1\ [297n] (a) In General.--In the case of any
individual--
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\1\ Title VIII does not contain a section 843 or 844. A section 845
appears in part G on page 810.
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(1) who has received a baccalaureate or associate
degree in nursing (or an equivalent degree), a diploma
in nursing, or a graduate degree in nursing;
(2) who obtained (A) one or more loans from a loan
fund established under subpart II \2\, or (B) any other
educational loan for nurse training costs; and
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\2\ So in law. Probably should read ``part''.
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(3) who enters into an agreement with the Secretary
to serve as nurse for a period of not less than two
years at a health care facility with a critical
shortage of nurses, or in a accredited school of
nursing, as defined by section 801(2), as nurse
faculty;
the Secretary shall make payments in accordance with subsection
(b), for and on behalf of that individual, on the principal of
and interest on any loan of that individual described in
paragraph (2) of this subsection which is outstanding on the
date the individual begins the service specified in the
agreement described in paragraph (3) of this subsection. After
fiscal year 2007, the Secretary may not, pursuant to any
agreement entered into under this subsection, assign a nurse to
any private entity unless that entity is nonprofit.
(b) Manner of Payments.--The payments described in
subsection (a) shall be made by the Secretary as follows:
(1) Upon completion by the individual for whom the
payments are to be made of the first year of the
service specified in the agreement entered into with
the Secretary under subsection (a), the Secretary shall
pay 30 percent of the principal of, and the interest on
each loan of such individual described in subsection
(a)(2) which is outstanding on the date he began such
practice.
(2) Upon completion by that individual of the
second year of such service, the Secretary shall pay
another 30 percent of the principal of, and the
interest on each such loan.
(3) Upon completion by that individual of a third
year of such service, the Secretary shall pay another
25 percent of the principal of, and the interest on
each such loan.
(c) Payment by Due Date.--Notwithstanding the requirement
of completion of practice specified in subsection (b), the
Secretary shall, on or before the due date thereof, pay any
loan or loan installment which may fall due within the period
of service for which the borrower may receive payments under
this subsection, upon the declaration of such borrower, at such
times and in such manner as the Secretary may prescribe (and
supported by such other evidence as the Secretary may
reasonably require), that the borrower is then serving as
described by subsection (a)(3), and that the borrower will
continue to so serve for the period required (in the absence of
this subsection) to entitle the borrower to have made the
payments provided by this subsection for such period; except
that not more than 85 percent of the principal of any such loan
shall be paid pursuant to this subsection.
(d) Scholarship Program.--
(1) In general.--The Secretary shall (for fiscal
years 2003 and 2004) and may (for fiscal years
thereafter) carry out a program of entering into
contracts with eligible individuals under which such
individuals agree to serve as nurses for a period of
not less than 2 years at a health care facility with a
critical shortage of nurses, in consideration of the
Federal Government agreeing to provide to the
individuals scholarships for attendance at schools of
nursing.
(2) Eligible individuals.--In this subsection, the
term ``eligible individual'' means an individual who is
enrolled or accepted for enrollment as a full-time or
part-time student in a school of nursing.
(3) Service requirement.--
(A) In general.--The Secretary may not
enter into a contract with an eligible
individual under this subsection unless the
individual agrees to serve as a nurse at a
health care facility with a critical shortage
of nurses for a period of full-time service of
not less than 2 years, or for a period of part-
time service in accordance with subparagraph
(B).
(B) Part-time service.--An individual may
complete the period of service described in
subparagraph (A) on a part-time basis if the
individual has a written agreement that--
(i) is entered into by the facility
and the individual and is approved by
the Secretary; and
(ii) provides that the period of
obligated service will be extended so
that the aggregate amount of service
performed will equal the amount of
service that would be performed through
a period of full-time service of not
less than 2 years.
(4) Applicability of certain provisions.--The
provisions of subpart III of part D of title III shall,
except as inconsistent with this section, apply to the
program established in paragraph (1) in the same manner
and to the same extent as such provisions apply to the
National Health Service Corps Scholarship Program
established in such subpart.
(e) Preferences Regarding Participants.--In entering into
agreements under subsection (a) or (d), the Secretary shall
give preference to qualified applicants with the greatest
financial need.
(f) Breach of Agreement.--The Secretary may make payments
under subsection (a) on behalf of an individual only if the
agreement under such subsection provides that section 860(c) is
applicable to the individual.
(g) Breach of Agreement.--
(1) In general.--In the case of any program under
this section under which an individual makes an
agreement to provide health services for a period of
time in accordance with such program in consideration
of receiving an award of Federal funds regarding
education as a nurse (including an award for the
repayment of loans), the following applies if the
agreement provides that this subsection is applicable:
(A) In the case of a program under this
section that makes an award of Federal funds
for attending an accredited program of nursing
(in this section referred to as a ``nursing
program''), the individual is liable to the
Federal Government for the amount of such award
(including amounts provided for expenses
related to such attendance), and for interest
on such amount at the maximum legal prevailing
rate, if the individual--
(i) fails to maintain an acceptable
level of academic standing in the
nursing program (as indicated by the
program in accordance with requirements
established by the Secretary);
(ii) is dismissed from the nursing
program for disciplinary reasons; or
(iii) voluntarily terminates the
nursing program.
(B) The individual is liable to the Federal
Government for the amount of such award
(including amounts provided for expenses
related to such attendance), and for interest
on such amount at the maximum legal prevailing
rate, if the individual fails to provide health
services in accordance with the program under
this section for the period of time applicable
under the program.
(2) Waiver or suspension of liability.--In the case
of an individual or health facility making an agreement
for purposes of paragraph (1), the Secretary shall
provide for the waiver or suspension of liability under
such subsection if compliance by the individual or the
health facility, as the case may be, with the
agreements involved is impossible, or would involve
extreme hardship to the individual or facility, and if
enforcement of the agreements with respect to the
individual or facility would be unconscionable.
(3) Date certain for recovery.--Subject to
paragraph (2), any amount that the Federal Government
is entitled to recover under paragraph (1) shall be
paid to the United States not later than the expiration
of the 3-year period beginning on the date the United
States becomes so entitled.
(4) Availability.--Amounts recovered under
paragraph (1) with respect to a program under this
section shall be available for the purposes of such
program, and shall remain available for such purposes
until expended.
(h) Reports.--Not later than 18 months after the date of
enactment of the Nurse Reinvestment Act, and annually
thereafter, the Secretary shall prepare and submit to the
Congress a report describing the programs carried out under
this section, including statements regarding--
(1) the number of enrollees, scholarships, loan
repayments, and grant recipients;
(2) the number of graduates;
(3) the amount of scholarship payments and loan
repayments made;
(4) which educational institution the recipients
attended;
(5) the number and placement location of the
scholarship and loan repayment recipients at health
care facilities with a critical shortage of nurses;
(6) the default rate and actions required;
(7) the amount of outstanding default funds of both
the scholarship and loan repayment programs;
(8) to the extent that it can be determined, the
reason for the default;
(9) the demographics of the individuals
participating in the scholarship and loan repayment
programs;
(10) justification for the allocation of funds
between the scholarship and loan repayment programs;
and
(11) an evaluation of the overall costs and
benefits of the programs.
(i) Funding.--
(1) Authorization of appropriations.--For the
purpose of payments under agreements entered into under
subsection (a) or (d), there are authorized to be
appropriated such sums as may be necessary for each of
fiscal years 2003 through 2007.
(2) Allocations.--Of the amounts appropriated under
paragraph (1), the Secretary may, as determined
appropriate by the Secretary, allocate amounts between
the program under subsection (a) and the program under
subsection (d).
nurse faculty loan program
Sec. 846A. [297n-1] (a) School of Nursing Student Loan
Fund.--The Secretary, acting through the Administrator of the
Health Resources and Services Administration, may enter into an
agreement with any accredited school of nursing for the
establishment and operation of a student loan fund in
accordance with this section, to increase the number of
qualified nursing faculty.
(b) Agreements.--Each agreement entered into under
subsection (a) shall--
(1) provide for the establishment of a student loan
fund by the school involved;
(2) provide for deposit in the fund of--
(A) the Federal capital contributions to
the fund;
(B) an amount equal to not less than one-
ninth of such Federal capital contributions,
contributed by such school;
(C) collections of principal and interest
on loans made from the fund; and
(D) any other earnings of the fund;
(3) provide that the fund will be used only for
loans to students of the school in accordance with
subsection (c) and for costs of collection of such
loans and interest thereon;
(4) provide that loans may be made from such fund
only to students pursuing a full-time course of study
or, at the discretion of the Secretary, a part-time
course of study in an advanced degree program described
in section 811(b); and
(5) contain such other provisions as are necessary
to protect the financial interests of the United
States.
(c) Loan Provisions.--Loans from any student loan fund
established by a school pursuant to an agreement under
subsection (a) shall be made to an individual on such terms and
conditions as the school may determine, except that--
(1) such terms and conditions are subject to any
conditions, limitations, and requirements prescribed by
the Secretary;
(2) in the case of any individual, the total of the
loans for any academic year made by schools of nursing
from loan funds established pursuant to agreements
under subsection (a) may not exceed $35,500, during
fiscal years 2010 and 2011 fiscal years (after fiscal
year 2011, such amounts shall be adjusted to provide
for a cost-of-attendance increase for the yearly loan
rate and the aggregate loan;
(3) an amount up to 85 percent of any such loan
(plus interest thereon) shall be canceled by the school
as follows:
(A) upon completion by the individual of
each of the first, second, and third year of
full-time employment, required by the loan
agreement entered into under this subsection,
as a faculty member in an accredited a \1\
school of nursing, the school shall cancel 20
percent of the principle of, and the interest
on, the amount of such loan unpaid on the first
day of such employment; and
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\1\ So in law. Probably should read ``...as a faculty member in an
accredited school of nursing...''.
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(B) upon completion by the individual of
the fourth year of full-time employment,
required by the loan agreement entered into
under this subsection, as a faculty member in a
school of nursing, the school shall cancel 25
percent of the principle of, and the interest
on, the amount of such loan unpaid on the first
day of such employment;
(4) such a loan may be used to pay the cost of
tuition, fees, books, laboratory expenses, and other
reasonable education expenses;
(5) such a loan shall be repayable in equal or
graduated periodic installments (with the right of the
borrower to accelerate repayment) over the 10-year
period that begins 9 months after the individual ceases
to pursue a course of study at a school of nursing; and
(6) such a loan shall--
(A) beginning on the date that is 3 months
after the individual ceases to pursue a course
of study at a school of nursing, bear interest
on the unpaid balance of the loan at the rate
of 3 percent per annum; or
(B) subject to subsection (e), if the
school of nursing determines that the
individual will not complete such course of
study or serve as a faculty member as required
under the loan agreement under this subsection,
bear interest on the unpaid balance of the loan
at the prevailing market rate.
(d) Payment of Proportionate Share.--Where all or any part
of a loan, or interest, is canceled under this section, the
Secretary shall pay to the school an amount equal to the
school's proportionate share of the canceled portion, as
determined by the Secretary.
(e) Review by Secretary.--At the request of the individual
involved, the Secretary may review any determination by an
accredited school of nursing under subsection (c)(6)(B).
(f) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2014.
SEC. 847. [297O] ELIGIBLE INDIVIDUAL STUDENT LOAN REPAYMENT.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may enter into an agreement with eligible
individuals for the repayment of education loans, in accordance
with this section, to increase the number of qualified nursing
faculty.
(b) Agreements.--Each agreement entered into under this
subsection shall require that the eligible individual shall
serve as a full-time member of the faculty of an accredited
school of nursing, for a total period, in the aggregate, of at
least 4 years during the 6-year period beginning on the later
of--
(1) the date on which the individual receives a
master's or doctorate nursing degree from an accredited
school of nursing; or
(2) the date on which the individual enters into an
agreement under this subsection.
(c) Agreement Provisions.--Agreements entered into pursuant
to subsection (b) shall be entered into on such terms and
conditions as the Secretary may determine, except that--
(1) not more than 10 months after the date on which
the 6-year period described under subsection (b)
begins, but in no case before the individual starts as
a full-time member of the faculty of an accredited
school of nursing the Secretary shall begin making
payments, for and on behalf of that individual, on the
outstanding principal of, and interest on, any loan of
that individual obtained to pay for such degree;
(2) for an individual who has completed a master's
in nursing or equivalent degree in nursing--
(A) payments may not exceed $10,000 per
calendar year; and
(B) total payments may not exceed $40,000
during the 2010 and 2011 fiscal years (after
fiscal year 2011, such amounts shall be
adjusted to provide for a cost-of-attendance
increase for the yearly loan rate and the
aggregate loan); and
(3) for an individual who has completed a doctorate
or equivalent degree in nursing--
(A) payments may not exceed $20,000 per
calendar year; and
(B) total payments may not exceed $80,000
during the 2010 and 2011 fiscal years (adjusted
for subsequent fiscal years as provided for in
the same manner as in paragraph (2)(B)).
(d) Breach of Agreement.--
(1) In general.--In the case of any agreement made
under subsection (b), the individual is liable to the
Federal Government for the total amount paid by the
Secretary under such agreement, and for interest on
such amount at the maximum legal prevailing rate, if
the individual fails to meet the agreement terms
required under such subsection.
(2) Waiver or suspension of liability.--In the case
of an individual making an agreement for purposes of
paragraph (1), the Secretary shall provide for the
waiver or suspension of liability under such paragraph
if compliance by the individual with the agreement
involved is impossible or would involve extreme
hardship to the individual or if enforcement of the
agreement with respect to the individual would be
unconscionable.
(3) Date certain for recovery.--Subject to
paragraph (2), any amount that the Federal Government
is entitled to recover under paragraph (1) shall be
paid to the United States not later than the expiration
of the 3-year period beginning on the date the United
States becomes so entitled.
(4) Availability.--Amounts recovered under
paragraph (1) shall be available to the Secretary for
making loan repayments under this section and shall
remain available for such purpose until expended.
(e) Eligible Individual Defined.--For purposes of this
section, the term ``eligible individual'' means an individual
who--
(1) is a United States citizen, national, or lawful
permanent resident;
(2) holds an unencumbered license as a registered
nurse; and
(3) has either already completed a master's or
doctorate nursing program at an accredited school of
nursing or is currently enrolled on a full-time or
part-time basis in such a program.
(f) Priority.--For the purposes of this section and section
846A, funding priority will be awarded to School of Nursing
Student Loans that support doctoral nursing students or
Individual Student Loan Repayment that support doctoral nursing
students.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2014.
PART F--NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE
SEC. 851. [297T] NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND
PRACTICE.
(a) Establishment.--The Secretary shall establish an
advisory council to be known as the National Advisory Council
on Nurse Education and Practice (in this section referred to as
the ``Advisory Council'').
(b) Composition.--
(1) In general.--The Advisory Council shall be
composed of--
(A) not less than 21, nor more than 23
individuals, who are not officers or employees
of the Federal Government, appointed by the
Secretary without regard to the Federal civil
service laws, of which--
(i) 2 shall be selected from full-
time students enrolled in schools of
nursing;
(ii) 2 shall be selected from the
general public;
(iii) 2 shall be selected from
practicing professional nurses; and
(iv) 9 shall be selected from among
the leading authorities in the various
fields of nursing, higher, secondary
education, and associate degree schools
of nursing, and from representatives of
advanced education nursing groups (such
as nurse practitioners, nurse midwives,
and nurse anesthetists), hospitals, and
other institutions and organizations
which provide nursing services; and
(B) the Secretary (or the delegate of the
Secretary (who shall be an ex officio member
and shall serve as the Chairperson)).
(2) Appointment.--Not later than 90 days after the
date of enactment of this Act \1\, the Secretary shall
appoint the members of the Advisory Council and each
such member shall serve a 4 year term. In making such
appointments, the Secretary shall ensure a fair balance
between the nursing professions, a broad geographic
representation of members and a balance between urban
and rural members. Members shall be appointed based on
their competence, interest, and knowledge of the
mission of the profession involved. A majority of the
members shall be nurses.
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\1\ So in law. The reference to ``this Act'' means the Public
Health Service Act, which was enacted July 1, 1944. Probably should be
a reference to the Health Professions Education Partnerships Act of
1998, which added section 845. That Act is Public Law 105-392, enacted
November 13, 1998. (Section 123(5) of that Public Law (112 Stat. 3569)
added section 845.)
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(3) Minority representation.--In appointing the
members of the Advisory Council under paragraph (1),
the Secretary shall ensure the adequate representation
of minorities.
(c) Vacancies.--
(1) In general.--A vacancy on the Advisory Council
shall be filled in the manner in which the original
appointment was made and shall be subject to any
conditions which applied with respect to the original
appointment.
(2) Filling unexpired term.--An individual chosen
to fill a vacancy shall be appointed for the unexpired
term of the member replaced.
(d) Duties.--The Advisory Council shall--
(1) provide advice and recommendations to the
Secretary and Congress concerning policy matters
arising in the administration of this title, including
the range of issues relating to the nurse workforce,
education, and practice improvement;
(2) provide advice to the Secretary and Congress in
the preparation of general regulations and with respect
to policy matters arising in the administration of this
title, including the range of issues relating to nurse
supply, education and practice improvement; and
(3) not later than 3 years after the date of
enactment of this section, and annually thereafter,
prepare and submit to the Secretary, the Committee on
Labor and Human Resources of the Senate, and the
Committee on Commerce of the House of Representatives,
a report describing the activities of the Council,
including findings and recommendations made by the
Council concerning the activities under this title.
(e) Meetings and Documents.--
(1) Meetings.--The Advisory Council shall meet not
less than 2 times each year. Such meetings shall be
held jointly with other related entities established
under this title where appropriate.
(2) Documents.--Not later than 14 days prior to the
convening of a meeting under paragraph (1), the
Advisory Council shall prepare and make available an
agenda of the matters to be considered by the Advisory
Council at such meeting. At any such meeting, the
Advisory Council shall distribute materials with
respect to the issues to be addressed at the meeting.
Not later than 30 days after the adjourning of such a
meeting, the Advisory Council shall prepare and make
available a summary of the meeting and any actions
taken by the Council based upon the meeting.
(f) Compensation and Expenses.--
(1) Compensation.--Each member of the Advisory
Council shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic pay
prescribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each
day (including travel time) during which such member is
engaged in the performance of the duties of the
Council. All members of the Council who are officers or
employees of the United States shall serve without
compensation in addition to that received for their
services as officers or employees of the United States.
(2) Expenses.--The members of the Advisory Council
shall be allowed travel expenses, including per diem in
lieu of subsistence, at rates authorized for employees
of agencies under subchapter I of chapter 57 of title
5, United States Code, while away from their homes or
regular places of business in the performance of
services for the Council.
(g) Funding.--Amounts appropriated under this title may be
utilized by the Secretary to support the nurse education and
practice activities of the Council.
(h) FACA.--The Federal Advisory Committee Act shall apply
to the Advisory Committee under this section only to the extent
that the provisions of such Act do not conflict with the
requirements of this section.
PART G--PUBLIC SERVICE ANNOUNCEMENTS
SEC. 861. [297W] PUBLIC SERVICE ANNOUNCEMENTS.
(a) In General.--The Secretary shall develop and issue
public service announcements that advertise and promote the
nursing profession, highlight the advantages and rewards of
nursing, and encourage individuals to enter the nursing
profession.
(b) Method.--The public service announcements described in
subsection (a) shall be broadcast through appropriate media
outlets, including television or radio, in a manner intended to
reach as wide and diverse an audience as possible.
(c) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2003 through 2007.
SEC. 862. [297X] STATE AND LOCAL PUBLIC SERVICE ANNOUNCEMENTS.
(a) In General.--The Secretary may award grants to eligible
entities to support State and local advertising campaigns
through appropriate media outlets to promote the nursing
profession, highlight the advantages and rewards of nursing,
and encourage individuals from disadvantaged backgrounds to
enter the nursing profession.
(b) Use of Funds.--An eligible entity that receives a grant
under subsection (a) shall use funds received through such
grant to acquire local television and radio time, place
advertisements in local newspapers, or post information on
billboards or on the Internet in a manner intended to reach as
wide and diverse an audience as possible, in order to--
(1) advertise and promote the nursing profession;
(2) promote nursing education programs;
(3) inform the public of financial assistance
regarding such education programs;
(4) highlight individuals in the community who are
practicing nursing in order to recruit new nurses; or
(5) provide any other information to recruit
individuals for the nursing profession.
(c) Limitation.--An eligible entity that receives a grant
under subsection (a) shall not use funds received through such
grant to advertise particular employment opportunities.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2003 through 2007.
PART H--COMPREHENSIVE GERIATRIC EDUCATION
SEC. 865. [298] COMPREHENSIVE GERIATRIC EDUCATION.
(a) Program Authorized.--The Secretary shall award grants
to eligible entities to develop and implement, in coordination
with programs under section 753, programs and initiatives to
train and educate individuals in providing geriatric care for
the elderly.
(b) Use of Funds.--An eligible entity that receives a grant
under subsection (a) shall use funds under such grant to--
(1) provide training to individuals who will
provide geriatric care for the elderly;
(2) develop and disseminate curricula relating to
the treatment of the health problems of elderly
individuals;
(3) train faculty members in geriatrics;
(4) provide continuing education to individuals who
provide geriatric care; or
(5) establish traineeships for individuals who are
preparing for advanced education nursing degrees in
geriatric nursing, long-term care, gero-psychiatric
nursing or other nursing areas that specialize in the
care of the elderly population.
(c) Application.--An eligible entity desiring a grant under
subsection (a) shall submit an application to the Secretary at
such time, in such manner, and containing such information as
the Secretary may reasonably require.
(d) Eligible Entity.--For purposes of this section, the
term ``eligible entity'' includes a school of nursing, a health
care facility, a program leading to certification as a
certified nurse assistant, a partnership of such a school and
facility, or a partnership of such a program and facility.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of fiscal years 2010 through 2014.
PART I--FUNDING
SEC. 871. [298D] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out parts B, C, and D (subject
to section 851(g)), there are authorized to be appropriated
$338,000,000 for fiscal year 2010, and such sums as may be
necessary for each of the fiscal years 2011 through
2016.ATTORNEY: PMG/FD (Dec. 29, 1999) deg.
TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY \1\
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\1\ Section 2 of Public Law 106-129 (113 Stat. 1653) designated the
Agency as the Agency for Healthcare Research and Quality. Formerly it
was designated as the Agency for Health Care Policy and Research. See
section 6103 of Public Law 101-239 (103 Stat. 2189).
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PART A--ESTABLISHMENT AND GENERAL DUTIES
SEC. 901. [299] MISSION AND DUTIES.
(a) In General.--There is established within the Public
Health Service an agency to be known as the Agency for
Healthcare Research and Quality, which shall be headed by a
director appointed by the Secretary. The Secretary shall carry
out this title acting through the Director.
(b) Mission.--The purpose of the Agency is to enhance the
quality, appropriateness, and effectiveness of health services,
and access to such services, through the establishment of a
broad base of scientific research and through the promotion of
improvements in clinical and health system practices, including
the prevention of diseases and other health conditions. The
Agency shall promote health care quality improvement by
conducting and supporting--
(1) research that develops and presents scientific
evidence regarding all aspects of health care,
including--
(A) the development and assessment of
methods for enhancing patient participation in
their own care and for facilitating shared
patient-physician decision-making;
(B) the outcomes, effectiveness, and cost-
effectiveness of health care practices,
including preventive measures and long-term
care;
(C) existing and innovative technologies;
(D) the costs and utilization of, and
access to health care;
(E) the ways in which health care services
are organized, delivered, and financed and the
interaction and impact of these factors on the
quality of patient care;
(F) methods for measuring quality and
strategies for improving quality; and
(G) ways in which patients, consumers,
purchasers, and practitioners acquire new
information about best practices and health
benefits, the determinants and impact of their
use of this information;
(2) the synthesis and dissemination of available
scientific evidence for use by patients, consumers,
practitioners, providers, purchasers, policy makers,
and educators; and
(3) initiatives to advance private and public
efforts to improve health care quality.
(c) Requirements With Respect to Rural and Inner-City Areas
and Priority Populations.--
(1) Research, evaluations and demonstration
projects.--In carrying out this title, the Director
shall conduct and support research and evaluations, and
support demonstration projects, with respect to--
(A) the delivery of health care in inner-
city areas, and in rural areas (including
frontier areas); and
(B) health care for priority populations,
which shall include--
(i) low-income groups;
(ii) minority groups;
(iii) women;
(iv) children;
(v) the elderly; and
(vi) individuals with special
health care needs, including
individuals with disabilities and
individuals who need chronic care or
end-of-life health care.
(2) Process to ensure appropriate research.--The
Director shall establish a process to ensure that the
requirements of paragraph (1) are reflected in the
overall portfolio of research conducted and supported
by the Agency.
(3) Office of priority populations.--The Director
shall establish an Office of Priority Populations to
assist in carrying out the requirements of paragraph
(1).
SEC. 902. [299A] GENERAL AUTHORITIES.
(a) In General.--In carrying out section 901(b), the
Director shall conduct and support research, evaluations, and
training, support demonstration projects, research networks,
and multidisciplinary centers, provide technical assistance,
and disseminate information on health care and on systems for
the delivery of such care, including activities with respect
to--
(1) the quality, effectiveness, efficiency,
appropriateness and value of health care services;
(2) quality measurement and improvement;
(3) the outcomes, cost, cost-effectiveness, and use
of health care services and access to such services;
(4) clinical practice, including primary care and
practice-oriented research;
(5) health care technologies, facilities, and
equipment;
(6) health care costs, productivity, organization,
and market forces;
(7) health promotion and disease prevention,
including clinical preventive services;
(8) health statistics, surveys, database
development, and epidemiology; and
(9) medical liability.
(b) Health Services Training Grants.--
(1) In general.--The Director may provide training
grants in the field of health services research related
to activities authorized under subsection (a), to
include pre- and post-doctoral fellowships and training
programs, young investigator awards, and other programs
and activities as appropriate. In carrying out this
subsection, the Director shall make use of funds made
available under section 487(d)(3) as well as other
appropriated funds.
(2) Requirements.--In developing priorities for the
allocation of training funds under this subsection, the
Director shall take into consideration shortages in the
number of trained researchers who are addressing health
care issues for the priority populations identified in
section 901(c)(1)(B) and in addition, shall take into
consideration indications of long-term commitment,
amongst applicants for training funds, to addressing
health care needs of the priority populations.
(c) Multidisciplinary Centers.--The Director may provide
financial assistance to assist in meeting the costs of planning
and establishing new centers, and operating existing and new
centers, for multidisciplinary health services research,
demonstration projects, evaluations, training, and policy
analysis with respect to the matters referred to in subsection
(a).
(d) Relation to Certain Authorities Regarding Social
Security.--Activities authorized in this section shall be
appropriately coordinated with experiments, demonstration
projects, and other related activities authorized by the Social
Security Act and the Social Security Amendments of 1967.
Activities under subsection (a)(2) of this section that affect
the programs under titles XVIII, XIX and XXI of the Social
Security Act shall be carried out consistent with section 1142
of such Act.
(e) Disclaimer.--The Agency shall not mandate national
standards of clinical practice or quality health care
standards. Recommendations resulting from projects funded and
published by the Agency shall include a corresponding
disclaimer.
(f) Rule of Construction.--Nothing in this section shall be
construed to imply that the Agency's role is to mandate a
national standard or specific approach to quality measurement
and reporting. In research and quality improvement activities,
the Agency shall consider a wide range of choices, providers,
health care delivery systems, and individual preferences.
SEC. 903. [299A-1] RESEARCH ON HEALTH DISPARITIES.
(a) In General.--The Director shall--
(1) conduct and support research to identify
populations for which there is a significant disparity
in the quality, outcomes, cost, or use of health care
services or access to and satisfaction with such
services, as compared to the general population;
(2) conduct and support research on the causes of
and barriers to reducing the health disparities
identified in paragraph (1), taking into account such
factors as socioeconomic status, attitudes toward
health, the language spoken, the extent of formal
education, the area or community in which the
population resides, and other factors the Director
determines to be appropriate;
(3) conduct and support research and support
demonstration projects to identify, test, and evaluate
strategies for reducing or eliminating health
disparities, including development or identification of
effective service delivery models, and disseminate
effective strategies and models;
(4) develop measures and tools for the assessment
and improvement of the outcomes, quality, and
appropriateness of health care services provided to
health disparity populations;
(5) in carrying out section 902(c), provide support
to increase the number of researchers who are members
of health disparity populations, and the health
services research capacity of institutions that train
such researchers; and
(6) beginning with fiscal year 2003, annually
submit to the Congress a report regarding prevailing
disparities in health care delivery as it relates to
racial factors and socioeconomic factors in priority
populations.
(b) Research and Demonstration Projects.--
(1) In general.--In carrying out subsection (a),
the Director shall conduct and support research and
support demonstrations to--
(A) identify the clinical, cultural,
socioeconomic, geographic, and organizational
factors that contribute to health disparities,
including minority health disparity
populations, which research shall include
behavioral research, such as examination of
patterns of clinical decisionmaking, and
research on access, outreach, and the
availability of related support services (such
as cultural and linguistic services);
(B) identify and evaluate clinical and
organizational strategies to improve the
quality, outcomes, and access to care for
health disparity populations, including
minority health disparity populations;
(C) test such strategies and widely
disseminate those strategies for which there is
scientific evidence of effectiveness; and
(D) determine the most effective approaches
for disseminating research findings to health
disparity populations, including minority
populations.
(2) Use of certain strategies.--In carrying out
this section, the Director shall implement research
strategies and mechanisms that will enhance the
involvement of individuals who are members of minority
health disparity populations or other health disparity
populations, health services researchers who are such
individuals, institutions that train such individuals
as researchers, members of minority health disparity
populations or other health disparity populations for
whom the Agency is attempting to improve the quality
and outcomes of care, and representatives of
appropriate tribal or other community-based
organizations with respect to health disparity
populations. Such research strategies and mechanisms
may include the use of--
(A) centers of excellence that can
demonstrate, either individually or through
consortia, a combination of multi-disciplinary
expertise in outcomes or quality improvement
research, linkages to relevant sites of care,
and a demonstrated capacity to involve members
and communities of health disparity
populations, including minority health
disparity populations, in the planning,
conduct, dissemination, and translation of
research;
(B) provider-based research networks,
including health plans, facilities, or delivery
system sites of care (especially primary care),
that make extensive use of health care
providers who are members of health disparity
populations or who serve patients in such
populations and have the capacity to evaluate
and promote quality improvement;
(C) service delivery models (such as health
centers under section 330 and the Indian Health
Service) to reduce health disparities; and
(D) innovative mechanisms or strategies
that will facilitate the translation of past
research investments into clinical practices
that can reasonably be expected to benefit
these populations.
(c) Quality Measurement Development.--
(1) In general.--To ensure that health disparity
populations, including minority health disparity
populations, benefit from the progress made in the
ability of individuals to measure the quality of health
care delivery, the Director shall support the
development of quality of health care measures that
assess the experience of such populations with health
care systems, such as measures that assess the access
of such populations to health care, the cultural
competence of the care provided, the quality of the
care provided, the outcomes of care, or other aspects
of health care practice that the Director determines to
be important.
(2) Examination of certain practices.--The Director
shall examine the practices of providers that have a
record of reducing health disparities or have
experience in providing culturally competent health
services to minority health disparity populations or
other health disparity populations. In examining such
practices of providers funded under the authorities of
this Act, the Director shall consult with the heads of
the relevant agencies of the Public Health Service.
(3) Report.--Not later than 36 months after the
date of the enactment of this section, the Secretary,
acting through the Director, shall prepare and submit
to the appropriate committees of Congress a report
describing the state-of-the-art of quality measurement
for minority and other health disparity populations
that will identify critical unmet needs, the current
activities of the Department to address those needs,
and a description of related activities in the private
sector.
(d) Definition.--For purposes of this section:
(1) The term ``health disparity population'' has
the meaning given such term in section 464z-3, except
that in addition to the meaning so given, the Director
may determine that such term includes populations for
which there is a significant disparity in the quality,
outcomes, cost, or use of health care services or
access to or satisfaction with such services as
compared to the general population.
(2) The term ``minority'', with respect to
populations, refers to racial and ethnic minority
groups as defined in section 1707.
PART B--HEALTH CARE IMPROVEMENT RESEARCH
SEC. 911. [299B] HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
(a) Evidence Rating Systems.--In collaboration with experts
from the public and private sector, the Agency shall identify
and disseminate methods or systems to assess health care
research results, particularly methods or systems to rate the
strength of the scientific evidence underlying health care
practice, recommendations in the research literature, and
technology assessments. The Agency shall make methods or
systems for evidence rating widely available. Agency
publications containing health care recommendations shall
indicate the level of substantiating evidence using such
methods or systems.
(b) Health Care Improvement Research Centers and Provider-
Based Research Networks.--
(1) In general.--In order to address the full
continuum of care and outcomes research, to link
research to practice improvement, and to speed the
dissemination of research findings to community
practice settings, the Agency shall employ research
strategies and mechanisms that will link research
directly with clinical practice in geographically
diverse locations throughout the United States,
including--
(A) health care improvement research
centers that combine demonstrated
multidisciplinary expertise in outcomes or
quality improvement research with linkages to
relevant sites of care;
(B) provider-based research networks,
including plan, facility, or delivery system
sites of care (especially primary care), that
can evaluate outcomes and evaluate and promote
quality improvement; and
(C) other innovative mechanisms or
strategies to link research with clinical
practice.
(2) Requirements.--The Director is authorized to
establish the requirements for entities applying for
grants under this subsection.
SEC. 912. [299B-1] PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION
AND DELIVERY.
(a) Support for Efforts To Develop Information on
Quality.--
(1) Scientific and technical support.--In its role
as the principal agency for health care research and
quality, the Agency may provide scientific and
technical support for private and public efforts to
improve health care quality, including the activities
of accrediting organizations.
(2) Role of the agency.--With respect to paragraph
(1), the role of the Agency shall include--
(A) the identification and assessment of
methods for the evaluation of the health of--
(i) enrollees in health plans by
type of plan, provider, and provider
arrangements; and
(ii) other populations, including
those receiving long-term care
services;
(B) the ongoing development, testing, and
dissemination of quality measures, including
measures of health and functional outcomes;
(C) the compilation and dissemination of
health care quality measures developed in the
private and public sector;
(D) assistance in the development of
improved health care information systems;
(E) the development of survey tools for the
purpose of measuring participant and
beneficiary assessments of their health care;
and
(F) identifying and disseminating
information on mechanisms for the integration
of information on quality into purchaser and
consumer decision-making processes.
(b) Centers for Education and Research on Therapeutics.--
(1) In general.--The Secretary, acting through the
Director and in consultation with the Commissioner of
Food and Drugs, shall establish a program for the
purpose of making one or more grants for the
establishment and operation of one or more centers to
carry out the activities specified in paragraph (2).
(2) Required activities.--The activities referred
to in this paragraph are the following:
(A) The conduct of state-of-the-art
research for the following purposes:
(i) To increase awareness of--
(I) new uses of drugs,
biological products, and
devices;
(II) ways to improve the
effective use of drugs,
biological products, and
devices; and
(III) risks of new uses and
risks of combinations of drugs
and biological products.
(ii) To provide objective clinical
information to the following
individuals and entities:
(I) Health care
practitioners and other
providers of health care goods
or services.
(II) Pharmacists, pharmacy
benefit managers and
purchasers.
(III) Health maintenance
organizations and other managed
health care organizations.
(IV) Health care insurers
and governmental agencies.
(V) Patients and consumers.
(iii) To improve the quality of
health care while reducing the cost of
health care through--
(I) an increase in the
appropriate use of drugs,
biological products, or
devices; and
(II) the prevention of
adverse effects of drugs,
biological products, and
devices and the consequences of
such effects, such as
unnecessary hospitalizations.
(B) The conduct of research on the
comparative effectiveness, cost-effectiveness,
and safety of drugs, biological products, and
devices.
(C) Such other activities as the Secretary
determines to be appropriate, except that a
grant may not be expended to assist the
Secretary in the review of new drugs,
biological products, and devices.
(c) Reducing Errors in Medicine.--The Director shall, in
accordance with part C, conduct and support research and build
private-public partnerships to--
(1) identify the causes of preventable health care
errors and patient injury in health care delivery;
(2) develop, demonstrate, and evaluate strategies
for reducing errors and improving patient safety; and
(3) disseminate such effective strategies
throughout the health care industry.
SEC. 913. [299B-2] INFORMATION ON QUALITY AND COST OF CARE.
(a) In General.--The Director shall--
(1) conduct a survey to collect data on a
nationally representative sample of the population on
the cost, use and, for fiscal year 2001 and subsequent
fiscal years, quality of health care, including the
types of health care services Americans use, their
access to health care services, frequency of use, how
much is paid for the services used, the source of those
payments, the types and costs of private health
insurance, access, satisfaction, and quality of care
for the general population including rural residents
and also for populations identified in section 901(c);
and
(2) develop databases and tools that provide
information to States on the quality, access, and use
of health care services provided to their residents.
(b) Quality and Outcomes Information.--
(1) In general.--Beginning in fiscal year 2001, the
Director shall ensure that the survey conducted under
subsection (a)(1) will--
(A) identify determinants of health
outcomes and functional status, including the
health care needs of populations identified in
section 901(c), provide data to study the
relationships between health care quality,
outcomes, access, use, and cost, measure
changes over time, and monitor the overall
national impact of Federal and State policy
changes on health care;
(B) provide information on the quality of
care and patient outcomes for frequently
occurring clinical conditions for a nationally
representative sample of the population
including rural residents; and
(C) provide reliable national estimates for
children and persons with special health care
needs through the use of supplements or
periodic expansions of the survey.
In expanding the Medical Expenditure Panel Survey, as
in existence on the date of the enactment of this title
in fiscal year 2001 to collect information on the
quality of care, the Director shall take into account
any outcomes measurements generally collected by
private sector accreditation organizations.
(2) Annual report.--Beginning in fiscal year 2003,
the Secretary, acting through the Director, shall
submit to Congress an annual report on national trends
in the quality of health care provided to the American
people.
SEC. 914. [299B-3] INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.
(a) In General.--In order to foster a range of innovative
approaches to the management and communication of health
information, the Agency shall conduct and support research,
evaluations, and initiatives to advance--
(1) the use of information systems for the study of
health care quality and outcomes, including the
generation of both individual provider and plan-level
comparative performance data;
(2) training for health care practitioners and
researchers in the use of information systems;
(3) the creation of effective linkages between
various sources of health information, including the
development of information networks;
(4) the delivery and coordination of evidence-based
health care services, including the use of real-time
health care decision-support programs;
(5) the utility and comparability of health
information data and medical vocabularies by addressing
issues related to the content, structure, definitions
and coding of such information and data in consultation
with appropriate Federal, State and private entities;
(6) the use of computer-based health records in all
settings for the development of personal health records
for individual health assessment and maintenance, and
for monitoring public health and outcomes of care
within populations; and
(7) the protection of individually identifiable
information in health services research and health care
quality improvement.
(b) Demonstration.--The Agency shall support demonstrations
into the use of new information tools aimed at improving shared
decision-making between patients and their care-givers.
(c) Facilitating Public Access to Information.--The
Director shall work with appropriate public and private sector
entities to facilitate public access to information regarding
the quality of and consumer satisfaction with health care.
SEC. 915. [299B-4] RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN
UNDERSERVED AREAS.
(a) Preventive Services Task Force.--
(1) Establishment and purpose.--The Director shall
convene an independent Preventive Services Task Force
(referred to in this subsection as the ``Task Force'')
to be composed of individuals with appropriate
expertise. Such Task Force shall review the scientific
evidence related to the effectiveness, appropriateness,
and cost-effectiveness of clinical preventive services
for the purpose of developing recommendations for the
health care community, and updating previous clinical
preventive recommendations, to be published in the
Guide to Clinical Preventive Services (referred to in
this section as the ``Guide''), for individuals and
organizations delivering clinical services, including
primary care professionals, health care systems,
professional societies, employers, community
organizations, non-profit organizations, Congress and
other policy-makers, governmental public health
agencies, health care quality organizations, and
organizations developing national health objectives.
Such recommendations shall consider clinical preventive
best practice recommendations from the Agency for
Healthcare Research and Quality, the National
Institutes of Health, the Centers for Disease Control
and Prevention, the Institute of Medicine, specialty
medical associations, patient groups, and scientific
societies.
(2) Duties.--The duties of the Task Force shall
include--
(A) the development of additional topic
areas for new recommendations and interventions
related to those topic areas, including those
related to specific sub-populations and age
groups;
(B) at least once during every 5-year
period, review interventions and update
recommendations related to existing topic
areas, including new or improved techniques to
assess the health effects of interventions;
(C) improved integration with Federal
Government health objectives and related target
setting for health improvement;
(D) the enhanced dissemination of
recommendations;
(E) the provision of technical assistance
to those health care professionals, agencies
and organizations that request help in
implementing the Guide recommendations; and
(F) the submission of yearly reports to
Congress and related agencies identifying gaps
in research, such as preventive services that
receive an insufficient evidence statement, and
recommending priority areas that deserve
further examination, including areas related to
populations and age groups not adequately
addressed by current recommendations.
(3) Role of agency.--The Agency shall provide
ongoing administrative, research, and technical support
for the operations of the Task Force, including
coordinating and supporting the dissemination of the
recommendations of the Task Force, ensuring adequate
staff resources, and assistance to those organizations
requesting it for implementation of the Guide's
recommendations.
(4) Coordination with community preventive services
task force.--The Task Force shall take appropriate
steps to coordinate its work with the Community
Preventive Services Task Force and the Advisory
Committee on Immunization Practices, including the
examination of how each task force's recommendations
interact at the nexus of clinic and community.
(5) Operation.--Operation. In carrying out the
duties under paragraph (2), the Task Force is not
subject to the provisions of Appendix 2 of title 5,
United States Code.
(6) Independence.--All members of the Task Force
convened under this subsection, and any recommendations
made by such members, shall be independent and, to the
extent practicable, not subject to political pressure.
(7) Authorization of appropriations.--There are
authorized to be appropriated such sums as may be
necessary for each fiscal year to carry out the
activities of the Task Force.
(b) Primary Care Research.--
(1) In general.--There is established within the
Agency a Center for Primary Care Research (referred to
in this subsection as the ``Center'') that shall serve
as the principal source of funding for primary care
practice research in the Department of Health and Human
Services. For purposes of this paragraph, primary care
research focuses on the first contact when illness or
health concerns arise, the diagnosis, treatment or
referral to specialty care, preventive care, and the
relationship between the clinician and the patient in
the context of the family and community.
(2) Research.--In carrying out this section, the
Center shall conduct and support research concerning--
(A) the nature and characteristics of
primary care practice;
(B) the management of commonly occurring
clinical problems;
(C) the management of undifferentiated
clinical problems; and
(D) the continuity and coordination of
health services.
SEC. 916. [299B-5] HEALTH CARE PRACTICE AND TECHNOLOGY INNOVATION.
(a) In General.--The Director shall promote innovation in
evidence-based health care practices and technologies by--
(1) conducting and supporting research on the
development, diffusion, and use of health care
technology;
(2) developing, evaluating, and disseminating
methodologies for assessments of health care practices
and technologies;
(3) conducting intramural and supporting extramural
assessments of existing and new health care practices
and technologies;
(4) promoting education and training and providing
technical assistance in the use of health care practice
and technology assessment methodologies and results;
and
(5) working with the National Library of Medicine
and the public and private sector to develop an
electronic clearinghouse of currently available
assessments and those in progress.
(b) Specification of Process.--
(1) In general.--Not later than December 31, 2000,
the Director shall develop and publish a description of
the methods used by the Agency and its contractors for
health care practice and technology assessment.
(2) Consultations.--In carrying out this
subsection, the Director shall cooperate and consult
with the Assistant Secretary for Health, the
Administrator of the Centers for Medicare & Medicaid
Services, the Director of the National Institutes of
Health, the Commissioner of Food and Drugs, and the
heads of any other interested Federal department or
agency, and shall seek input, where appropriate, from
professional societies and other private and public
entities.
(3) Methodology.--The Director shall, in developing
the methods used under paragraph (1), consider--
(A) safety, efficacy, and effectiveness;
(B) legal, social, and ethical
implications;
(C) costs, benefits, and cost-
effectiveness;
(D) comparisons to alternate health care
practices and technologies; and
(E) requirements of Food and Drug
Administration approval to avoid duplication.
(c) Specific Assessments.--
(1) In general.--The Director shall conduct or
support specific assessments of health care
technologies and practices.
(2) Requests for assessments.--The Director is
authorized to conduct or support assessments, on a
reimbursable basis, for the Centers for Medicare &
Medicaid Services, the Department of Defense, the
Department of Veterans Affairs, the Office of Personnel
Management, and other public or private entities.
(3) Grants and contracts.--In addition to
conducting assessments, the Director may make grants
to, or enter into cooperative agreements or contracts
with, entities described in paragraph (4) for the
purpose of conducting assessments of experimental,
emerging, existing, or potentially outmoded health care
technologies, and for related activities.
(4) Eligible entities.--An entity described in this
paragraph is an entity that is determined to be
appropriate by the Director, including academic medical
centers, research institutions and organizations,
professional organizations, third party payers,
governmental agencies, minority institutions of higher
education (such as Historically Black Colleges and
Universities, and Hispanic institutions), and consortia
of appropriate research entities established for the
purpose of conducting technology assessments.
(d) Medical Examination of Certain Victims.--
(1) In general.--The Director shall develop and
disseminate a report on evidence-based clinical
practices for--
(A) the examination and treatment by health
professionals of individuals who are victims of
sexual assault (including child molestation) or
attempted sexual assault; and
(B) the training of health professionals,
in consultation with the Health Resources and
Services Administration, on performing medical
evidentiary examinations of individuals who are
victims of child abuse or neglect, sexual
assault, elder abuse, or domestic violence.
(2) Certain considerations.--In identifying the
issues to be addressed by the report, the Director
shall, to the extent practicable, take into
consideration the expertise and experience of Federal
and State law enforcement officials regarding the
victims referred to in paragraph (1), and of other
appropriate public and private entities (including
medical societies, victim services organizations,
sexual assault prevention organizations, and social
services organizations).
SEC. 917. [299B-6] COORDINATION OF FEDERAL GOVERNMENT QUALITY
IMPROVEMENT EFFORTS.
(a) Requirement.--
(1) In general.--To avoid duplication and ensure
that Federal resources are used efficiently and
effectively, the Secretary, acting through the
Director, shall coordinate all research, evaluations,
and demonstrations related to health services research,
quality measurement and quality improvement activities
undertaken and supported by the Federal Government.
(2) Specific activities.--The Director, in
collaboration with the appropriate Federal officials
representing all concerned executive agencies and
departments, shall develop and manage a process to--
(A) improve interagency coordination,
priority setting, and the use and sharing of
research findings and data pertaining to
Federal quality improvement programs,
technology assessment, and health services
research;
(B) strengthen the research information
infrastructure, including databases, pertaining
to Federal health services research and health
care quality improvement initiatives;
(C) set specific goals for participating
agencies and departments to further health
services research and health care quality
improvement; and
(D) strengthen the management of Federal
health care quality improvement programs.
(b) Study by the Institute of Medicine.--
(1) In general.--To provide Congress, the
Department of Health and Human Services, and other
relevant departments with an independent, external
review of their quality oversight, quality improvement
and quality research programs, the Secretary shall
enter into a contract with the Institute of Medicine--
(A) to describe and evaluate current
quality improvement, quality research and
quality monitoring processes through--
(i) an overview of pertinent health
services research activities and
quality improvement efforts conducted
by all Federal programs, with
particular attention paid to those
under titles XVIII, XIX, and XXI of the
Social Security Act; and
(ii) a summary of the partnerships
that the Department of Health and Human
Services has pursued with private
accreditation, quality measurement and
improvement organizations; and
(B) to identify options and make
recommendations to improve the efficiency and
effectiveness of quality improvement programs
through--
(i) the improved coordination of
activities across the medicare,
medicaid and child health insurance
programs under titles XVIII, XIX and
XXI of the Social Security Act and
health services research programs;
(ii) the strengthening of patient
choice and participation by
incorporating state-of-the-art quality
monitoring tools and making information
on quality available; and
(iii) the enhancement of the most
effective programs, consolidation as
appropriate, and elimination of
duplicative activities within various
Federal agencies.
(2) Requirements.--
(A) In general.--The Secretary shall enter
into a contract with the Institute of Medicine
for the preparation--
(i) not later than 12 months after
the date of the enactment of this
title, of a report providing an
overview of the quality improvement
programs of the Department of Health
and Human Services for the medicare,
medicaid, and CHIP programs under
titles XVIII, XIX, and XXI of the
Social Security Act; and
(ii) not later than 24 months after
the date of the enactment of this
title, of a final report containing
recommendations.
(B) Reports.--The Secretary shall submit
the reports described in subparagraph (A) to
the Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Ways and Means and
the Committee on Commerce of the House of
Representatives.
PART C--PATIENT SAFETY IMPROVEMENT
SEC. 921. [299B-21] DEFINITIONS.
In this part:
(1) HIPAA confidentiality regulations.--The term
``HIPAA confidentiality regulations'' means regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996
(Public Law 104-191; 110 Stat. 2033).
(2) Identifiable patient safety work product.--The
term ``identifiable patient safety work product'' means
patient safety work product that--
(A) is presented in a form and manner that
allows the identification of any provider that
is a subject of the work product, or any
providers that participate in activities that
are a subject of the work product;
(B) constitutes individually identifiable
health information as that term is defined in
the HIPAA confidentiality regulations; or
(C) is presented in a form and manner that
allows the identification of an individual who
reported information in the manner specified in
section 922(e).
(3) Nonidentifiable patient safety work product.--
The term ``nonidentifiable patient safety work
product'' means patient safety work product that is not
identifiable patient safety work product (as defined in
paragraph (2)).
(4) Patient safety organization.--The term
``patient safety organization'' means a private or
public entity or component thereof that is listed by
the Secretary pursuant to section 924(d).
(5) Patient safety activities.--The term ``patient
safety activities'' means the following activities:
(A) Efforts to improve patient safety and
the quality of health care delivery.
(B) The collection and analysis of patient
safety work product.
(C) The development and dissemination of
information with respect to improving patient
safety, such as recommendations, protocols, or
information regarding best practices.
(D) The utilization of patient safety work
product for the purposes of encouraging a
culture of safety and of providing feedback and
assistance to effectively minimize patient
risk.
(E) The maintenance of procedures to
preserve confidentiality with respect to
patient safety work product.
(F) The provision of appropriate security
measures with respect to patient safety work
product.
(G) The utilization of qualified staff.
(H) Activities related to the operation of
a patient safety evaluation system and to the
provision of feedback to participants in a
patient safety evaluation system.
(6) Patient safety evaluation system.--The term
``patient safety evaluation system'' means the
collection, management, or analysis of information for
reporting to or by a patient safety organization.
(7) Patient safety work product.--
(A) In general.--Except as provided in
subparagraph (B), the term ``patient safety
work product'' means any data, reports,
records, memoranda, analyses (such as root
cause analyses), or written or oral
statements--
(i) which--
(I) are assembled or
developed by a provider for
reporting to a patient safety
organization and are reported
to a patient safety
organization; or
(II) are developed by a
patient safety organization for
the conduct of patient safety
activities;
and which could result in improved
patient safety, health care quality, or
health care outcomes; or
(ii) which identify or constitute
the deliberations or analysis of, or
identify the fact of reporting pursuant
to, a patient safety evaluation system.
(B) Clarification.--
(i) Information described in
subparagraph (A) does not include a
patient's medical record, billing and
discharge information, or any other
original patient or provider record.
(ii) Information described in
subparagraph (A) does not include
information that is collected,
maintained, or developed separately, or
exists separately, from a patient
safety evaluation system. Such separate
information or a copy thereof reported
to a patient safety organization shall
not by reason of its reporting be
considered patient safety work product.
(iii) Nothing in this part shall be
construed to limit--
(I) the discovery of or
admissibility of information
described in this subparagraph
in a criminal, civil, or
administrative proceeding;
(II) the reporting of
information described in this
subparagraph to a Federal,
State, or local governmental
agency for public health
surveillance, investigation, or
other public health purposes or
health oversight purposes; or
(III) a provider's
recordkeeping obligation with
respect to information
described in this subparagraph
under Federal, State, or local
law.
(8) Provider.--The term ``provider'' means--
(A) an individual or entity licensed or
otherwise authorized under State law to provide
health care services, including--
(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, hospice
program, renal dialysis facility,
ambulatory surgical center, pharmacy,
physician or health care practitioner's
office, long term care facility,
behavior health residential treatment
facility, clinical laboratory, or
health center; or
(ii) a physician, physician
assistant, nurse practitioner, clinical
nurse specialist, certified registered
nurse anesthetist, certified nurse
midwife, psychologist, certified social
worker, registered dietitian or
nutrition professional, physical or
occupational therapist, pharmacist, or
other individual health care
practitioner; or
(B) any other individual or entity
specified in regulations promulgated by the
Secretary.
SEC. 922. [299B-22] PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
(a) Privilege.--Notwithstanding any other provision of
Federal, State, or local law, and subject to subsection (c),
patient safety work product shall be privileged and shall not
be--
(1) subject to a Federal, State, or local civil,
criminal, or administrative subpoena or order,
including in a Federal, State, or local civil or
administrative disciplinary proceeding against a
provider;
(2) subject to discovery in connection with a
Federal, State, or local civil, criminal, or
administrative proceeding, including in a Federal,
State, or local civil or administrative disciplinary
proceeding against a provider;
(3) subject to disclosure pursuant to section 552
of title 5, United States Code (commonly known as the
Freedom of Information Act) or any other similar
Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or
local governmental civil proceeding, criminal
proceeding, administrative rulemaking proceeding, or
administrative adjudicatory proceeding, including any
such proceeding against a provider; or
(5) admitted in a professional disciplinary
proceeding of a professional disciplinary body
established or specifically authorized under State law.
(b) Confidentiality of Patient Safety Work Product.--
Notwithstanding any other provision of Federal, State, or local
law, and subject to subsection (c), patient safety work product
shall be confidential and shall not be disclosed.
(c) Exceptions.--Except as provided in subsection (g)(3)--
(1) Exceptions from privilege and
confidentiality.--Subsections (a) and (b) shall not
apply to (and shall not be construed to prohibit) one
or more of the following disclosures:
(A) Disclosure of relevant patient safety
work product for use in a criminal proceeding,
but only after a court makes an in camera
determination that such patient safety work
product contains evidence of a criminal act and
that such patient safety work product is
material to the proceeding and not reasonably
available from any other source.
(B) Disclosure of patient safety work
product to the extent required to carry out
subsection (f)(4)(A).
(C) Disclosure of identifiable patient
safety work product if authorized by each
provider identified in such work product.
(2) Exceptions from confidentiality.--Subsection
(b) shall not apply to (and shall not be construed to
prohibit) one or more of the following disclosures:
(A) Disclosure of patient safety work
product to carry out patient safety activities.
(B) Disclosure of nonidentifiable patient
safety work product.
(C) Disclosure of patient safety work
product to grantees, contractors, or other
entities carrying out research, evaluation, or
demonstration projects authorized, funded,
certified, or otherwise sanctioned by rule or
other means by the Secretary, for the purpose
of conducting research to the extent that
disclosure of protected health information
would be allowed for such purpose under the
HIPAA confidentiality regulations.
(D) Disclosure by a provider to the Food
and Drug Administration with respect to a
product or activity regulated by the Food and
Drug Administration.
(E) Voluntary disclosure of patient safety
work product by a provider to an accrediting
body that accredits that provider.
(F) Disclosures that the Secretary may
determine, by rule or other means, are
necessary for business operations and are
consistent with the goals of this part.
(G) Disclosure of patient safety work
product to law enforcement authorities relating
to the commission of a crime (or to an event
reasonably believed to be a crime) if the
person making the disclosure believes,
reasonably under the circumstances, that the
patient safety work product that is disclosed
is necessary for criminal law enforcement
purposes.
(H) With respect to a person other than a
patient safety organization, the disclosure of
patient safety work product that does not
include materials that--
(i) assess the quality of care of
an identifiable provider; or
(ii) describe or pertain to one or
more actions or failures to act by an
identifiable provider.
(3) Exception from privilege.--Subsection (a) shall
not apply to (and shall not be construed to prohibit)
voluntary disclosure of nonidentifiable patient safety
work product.
(d) Continued Protection of Information After Disclosure.--
(1) In general.--Patient safety work product that
is disclosed under subsection (c) shall continue to be
privileged and confidential as provided for in
subsections (a) and (b), and such disclosure shall not
be treated as a waiver of privilege or confidentiality,
and the privileged and confidential nature of such work
product shall also apply to such work product in the
possession or control of a person to whom such work
product was disclosed.
(2) Exception.--Notwithstanding paragraph (1), and
subject to paragraph (3)--
(A) if patient safety work product is
disclosed in a criminal proceeding, the
confidentiality protections provided for in
subsection (b) shall no longer apply to the
work product so disclosed; and
(B) if patient safety work product is
disclosed as provided for in subsection
(c)(2)(B) (relating to disclosure of
nonidentifiable patient safety work product),
the privilege and confidentiality protections
provided for in subsections (a) and (b) shall
no longer apply to such work product.
(3) Construction.--Paragraph (2) shall not be
construed as terminating or limiting the privilege or
confidentiality protections provided for in subsection
(a) or (b) with respect to patient safety work product
other than the specific patient safety work product
disclosed as provided for in subsection (c).
(4) Limitations on actions.--
(A) Patient safety organizations.--
(i) In general.--A patient safety
organization shall not be compelled to
disclose information collected or
developed under this part whether or
not such information is patient safety
work product unless such information is
identified, is not patient safety work
product, and is not reasonably
available from another source.
(ii) Nonapplication.--The
limitation contained in clause (i)
shall not apply in an action against a
patient safety organization or with
respect to disclosures pursuant to
subsection (c)(1).
(B) Providers.--An accrediting body shall not take
an accrediting action against a provider based on the
good faith participation of the provider in the
collection, development, reporting, or maintenance of
patient safety work product in accordance with this
part. An accrediting body may not require a provider to
reveal its communications with any patient safety
organization established in accordance with this part.
(e) Reporter Protection.--
(1) In general.--A provider may not take an adverse
employment action, as described in paragraph (2),
against an individual based upon the fact that the
individual in good faith reported information--
(A) to the provider with the intention of
having the information reported to a patient
safety organization; or
(B) directly to a patient safety
organization.
(2) Adverse employment action.--For purposes of
this subsection, an ``adverse employment action''
includes--
(A) loss of employment, the failure to
promote an individual, or the failure to
provide any other employment-related benefit
for which the individual would otherwise be
eligible; or
(B) an adverse evaluation or decision made
in relation to accreditation, certification,
credentialing, or licensing of the individual.
(f) Enforcement.--
(1) Civil monetary penalty.--Subject to paragraphs
(2) and (3), a person who discloses identifiable
patient safety work product in knowing or reckless
violation of subsection (b) shall be subject to a civil
monetary penalty of not more than $10,000 for each act
constituting such violation.
(2) Procedure.--The provisions of section 1128A of
the Social Security Act, other than subsections (a) and
(b) and the first sentence of subsection (c)(1), shall
apply to civil money penalties under this subsection in
the same manner as such provisions apply to a penalty
or proceeding under section 1128A of the Social
Security Act.
(3) Relation to hipaa.--Penalties shall not be
imposed both under this subsection and under the
regulations issued pursuant to section 264(c)(1) of the
Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note) for a single act or
omission.
(4) Equitable relief.--
(A) In general.--Without limiting remedies
available to other parties, a civil action may
be brought by any aggrieved individual to
enjoin any act or practice that violates
subsection (e) and to obtain other appropriate
equitable relief (including reinstatement, back
pay, and restoration of benefits) to redress
such violation.
(B) Against state employees.--An entity
that is a State or an agency of a State
government may not assert the privilege
described in subsection (a) unless before the
time of the assertion, the entity or, in the
case of and with respect to an agency, the
State has consented to be subject to an action
described in subparagraph (A), and that consent
has remained in effect.
(g) Rule of Construction.--Nothing in this section shall be
construed--
(1) to limit the application of other Federal,
State, or local laws that provide greater privilege or
confidentiality protections than the privilege and
confidentiality protections provided for in this
section;
(2) to limit, alter, or affect the requirements of
Federal, State, or local law pertaining to information
that is not privileged or confidential under this
section;
(3) except as provided in subsection (i), to alter
or affect the implementation of any provision of the
HIPAA confidentiality regulations or section 1176 of
the Social Security Act (or regulations promulgated
under such section);
(4) to limit the authority of any provider, patient
safety organization, or other entity to enter into a
contract requiring greater confidentiality or
delegating authority to make a disclosure or use in
accordance with this section;
(5) as preempting or otherwise affecting any State
law requiring a provider to report information that is
not patient safety work product; or
(6) to limit, alter, or affect any requirement for
reporting to the Food and Drug Administration
information regarding the safety of a product or
activity regulated by the Food and Drug Administration.
(h) Clarification.--Nothing in this part prohibits any
person from conducting additional analysis for any purpose
regardless of whether such additional analysis involves issues
identical to or similar to those for which information was
reported to or assessed by a patient safety organization or a
patient safety evaluation system.
(i) Clarification of application of hipaa confidentiality
regulations to patient safety organizations.--For purposes of
applying the HIPAA confidentiality regulations--
(1) patient safety organizations shall be treated
as business associates; and
(2) patient safety activities of such organizations
in relation to a provider are deemed to be health care
operations (as defined in such regulations) of the
provider.
(j) Reports on Strategies to Improve Patient Safety.--
(1) Draft report.--Not later than the date that is
18 months after any network of patient safety databases
is operational, the Secretary, in consultation with the
Director, shall prepare a draft report on effective
strategies for reducing medical errors and increasing
patient safety. The draft report shall include any
measure determined appropriate by the Secretary to
encourage the appropriate use of such strategies,
including use in any federally funded programs. The
Secretary shall make the draft report available for
public comment and submit the draft report to the
Institute of Medicine for review.
(2) Final report.--Not later than 1 year after the
date described in paragraph (1), the Secretary shall
submit a final report to the Congress.
SEC. 923. [299B-23] NETWORK OF PATIENT SAFETY DATABASES.
(a) In General.--The Secretary shall facilitate the
creation of, and maintain, a network of patient safety
databases that provides an interactive evidence-based
management resource for providers, patient safety
organizations, and other entities. The network of databases
shall have the capacity to accept, aggregate across the
network, and analyze nonidentifiable patient safety work
product voluntarily reported by patient safety organizations,
providers, or other entities. The Secretary shall assess the
feasibility of providing for a single point of access to the
network for qualified researchers for information aggregated
across the network and, if feasible, provide for
implementation.
(b) Data Standards.--The Secretary may determine common
formats for the reporting to and among the network of patient
safety databases maintained under subsection (a) of
nonidentifiable patient safety work product, including
necessary work product elements, common and consistent
definitions, and a standardized computer interface for the
processing of such work product. To the extent practicable,
such standards shall be consistent with the administrative
simplification provisions of part C of title XI of the Social
Security Act.
(c) Use of Information.--Information reported to and among
the network of patient safety databases under subsection (a)
shall be used to analyze national and regional statistics,
including trends and patterns of health care errors. The
information resulting from such analyses shall be made
available to the public and included in the annual quality
reports prepared under section 913(b)(2).
SEC. 924. [299B-24] PATIENT SAFETY ORGANIZATION CERTIFICATION AND
LISTING.
(a) Certification.--
(1) Initial certification.--An entity that seeks to
be a patient safety organization shall submit an
initial certification to the Secretary that the
entity--
(A) has policies and procedures in place to
perform each of the patient safety activities
described in section 921(5); and
(B) upon being listed under subsection (d),
will comply with the criteria described in
subsection (b).
(2) Subsequent certifications.--An entity that is a
patient safety organization shall submit every 3 years
after the date of its initial listing under subsection
(d) a subsequent certification to the Secretary that
the entity--
(A) is performing each of the patient
safety activities described in section 921(5);
and
(B) is complying with the criteria
described in subsection (b).
(b) Criteria.--
(1) In general.--The following are criteria for the
initial and subsequent certification of an entity as a
patient safety organization:
(A) The mission and primary activity of the
entity are to conduct activities that are to
improve patient safety and the quality of
health care delivery.
(B) The entity has appropriately qualified
staff (whether directly or through contract),
including licensed or certified medical
professionals.
(C) The entity, within each 24-month period
that begins after the date of the initial
listing under subsection (d), has bona fide
contracts, each of a reasonable period of time,
with more than 1 provider for the purpose of
receiving and reviewing patient safety work
product.
(D) The entity is not, and is not a
component of, a health insurance issuer (as
defined in section 2791(b)(2)).
(E) The entity shall fully disclose--
(i) any financial, reporting, or
contractual relationship between the
entity and any provider that contracts
with the entity; and
(ii) if applicable, the fact that
the entity is not managed, controlled,
and operated independently from any
provider that contracts with the
entity.
(F) To the extent practical and
appropriate, the entity collects patient safety
work product from providers in a standardized
manner that permits valid comparisons of
similar cases among similar providers.
(G) The utilization of patient safety work
product for the purpose of providing direct
feedback and assistance to providers to
effectively minimize patient risk.
(2) Additional criteria for component
organizations.--If an entity that seeks to be a patient
safety organization is a component of another
organization, the following are additional criteria for
the initial and subsequent certification of the entity
as a patient safety organization:
(A) The entity maintains patient safety
work product separately from the rest of the
organization, and establishes appropriate
security measures to maintain the
confidentiality of the patient safety work
product.
(B) The entity does not make an
unauthorized disclosure under this part of
patient safety work product to the rest of the
organization in breach of confidentiality.
(C) The mission of the entity does not
create a conflict of interest with the rest of
the organization.
(c) Review of Certification.--
(1) In general.--
(A) Initial certification.--Upon the
submission by an entity of an initial
certification under subsection (a)(1), the
Secretary shall determine if the certification
meets the requirements of subparagraphs (A) and
(B) of such subsection.
(B) Subsequent certification.--Upon the
submission by an entity of a subsequent
certification under subsection (a)(2), the
Secretary shall review the certification with
respect to requirements of subparagraphs (A)
and (B) of such subsection.
(2) Notice of acceptance or non-acceptance.--If the
Secretary determines that--
(A) an entity's initial certification meets
requirements referred to in paragraph (1)(A),
the Secretary shall notify the entity of the
acceptance of such certification; or
(B) an entity's initial certification does
not meet such requirements, the Secretary shall
notify the entity that such certification is
not accepted and the reasons therefor.
(3) Disclosures regarding relationship to
providers.--The Secretary shall consider any
disclosures under subsection (b)(1)(E) by an entity and
shall make public findings on whether the entity can
fairly and accurately perform the patient safety
activities of a patient safety organization. The
Secretary shall take those findings into consideration
in determining whether to accept the entity's initial
certification and any subsequent certification
submitted under subsection (a) and, based on those
findings, may deny, condition, or revoke acceptance of
the entity's certification.
(d) Listing.--The Secretary shall compile and maintain a
listing of entities with respect to which there is an
acceptance of a certification pursuant to subsection (c)(2)(A)
that has not been revoked under subsection (e) or voluntarily
relinquished.
(e) Revocation of Acceptance of Certification.--
(1) In general.--If, after notice of deficiency, an
opportunity for a hearing, and a reasonable opportunity
for correction, the Secretary determines that a patient
safety organization does not meet the certification
requirements under subsection (a)(2), including
subparagraphs (A) and (B) of such subsection, the
Secretary shall revoke the Secretary's acceptance of
the certification of such organization.
(2) Supplying confirmation of notification to
providers.--Within 15 days of a revocation under
paragraph (1), a patient safety organization shall
submit to the Secretary a confirmation that the
organization has taken all reasonable actions to notify
each provider whose patient safety work product is
collected or analyzed by the organization of such
revocation.
(3) Publication of decision.--If the Secretary
revokes the certification of an organization under
paragraph (1), the Secretary shall--
(A) remove the organization from the
listing maintained under subsection (d); and
(B) publish notice of the revocation in the
Federal Register.
(f) Status of Data After Removal from Listing.--
(1) New data.--With respect to the privilege and
confidentiality protections described in section 922,
data submitted to an entity within 30 days after the
entity is removed from the listing under subsection
(e)(3)(A) shall have the same status as data submitted
while the entity was still listed.
(2) Protection to continue to apply.--If the
privilege and confidentiality protections described in
section 922 applied to patient safety work product
while an entity was listed, or to data described in
paragraph (1), such protections shall continue to apply
to such work product or data after the entity is
removed from the listing under subsection (e)(3)(A).
(g) Disposition of Work Product and Data.--If the Secretary
removes a patient safety organization from the listing as
provided for in subsection (e)(3)(A), with respect to the
patient safety work product or data described in subsection
(f)(1) that the patient safety organization received from
another entity, such former patient safety organization shall--
(1) with the approval of the other entity and a
patient safety organization, transfer such work product
or data to such patient safety organization;
(2) return such work product or data to the entity
that submitted the work product or data; or
(3) if returning such work product or data to such
entity is not practicable, destroy such work product or
data.
SEC. 925. [299B-24A] ACTIVITIES REGARDING WOMEN'S HEALTH.
(a) Establishment.--There is established within the Office
of the Director, an Office of Women's Health and Gender-Based
Research (referred to in this section as the ``Office''). The
Office shall be headed by a director who shall be appointed by
the Director of Healthcare and Research Quality.
(b) Purpose.--The official designated under subsection (a)
shall--
(1) report to the Director on the current Agency
level of activity regarding women's health, across,
where appropriate, age, biological, and sociocultural
contexts, in all aspects of Agency work, including the
development of evidence reports and clinical practice
protocols and the conduct of research into patient
outcomes, delivery of health care services, quality of
care, and access to health care;
(2) establish short-range and long-range goals and
objectives within the Agency for research important to
women's health and, as relevant and appropriate,
coordinate with other appropriate offices on activities
within the Agency that relate to health services and
medical effectiveness research, for issues of
particular concern to women;
(3) identify projects in women's health that should
be conducted or supported by the Agency;
(4) consult with health professionals,
nongovernmental organizations, consumer organizations,
women's health professionals, and other individuals and
groups, as appropriate, on Agency policy with regard to
women; and
(5) serve as a member of the Department of Health
and Human Services Coordinating Committee on Women's
Health (established under section 229(b)(4)).
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2010 through 2014.
SEC. 926. [299B-25] TECHNICAL ASSISTANCE.
The Secretary, acting through the Director, may provide
technical assistance to patient safety organizations, including
convening annual meetings for patient safety organizations to
discuss methodology, communication, data collection, or privacy
concerns.
SEC. 927. [299B-26] SEVERABILITY.
If any provision of this part is held to be
unconstitutional, the remainder of this part shall not be
affected.
PART D--HEALTH CARE QUALITY IMPROVEMENT
Subpart I--Quality Measure Development
SEC. 931. [299B-31] QUALITY MEASURE DEVELOPMENT.
(a) Quality Measure.--In this subpart, the term ``quality
measure'' means a standard for measuring the performance and
improvement of population health or of health plans, providers
of services, and other clinicians in the delivery of health
care services.
(b) Identification of Quality Measures.--
(1) Identification.--The Secretary, in consultation
with the Director of the Agency for Healthcare Research
and Quality and the Administrator of the Centers for
Medicare & Medicaid Services, shall identify, not less
often than triennially, gaps where no quality measures
exist and existing quality measures that need
improvement, updating, or expansion, consistent with
the national strategy under section 399HH, to the
extent available, for use in Federal health programs.
In identifying such gaps and existing quality measures
that need improvement, the Secretary shall take into
consideration--
(A) the gaps identified by the entity with
a contract under section 1890(a) of the Social
Security Act and other stakeholders;
(B) quality measures identified by the
pediatric quality measures program under
section 1139A of the Social Security Act; and
(C) quality measures identified through the
Medicaid Quality Measurement Program under
section 1139B of the Social Security Act.
(2) Publication.--The Secretary shall make
available to the public on an Internet website a report
on any gaps identified under paragraph (1) and the
process used to make such identification.
(c) Grants or Contracts for Quality Measure Development.--
(1) In general.--The Secretary shall award grants,
contracts, or intergovernmental agreements to eligible
entities for purposes of developing, improving,
updating, or expanding quality measures identified
under subsection (b).
(2) Prioritization in the development of quality
measures.--In awarding grants, contracts, or agreements
under this subsection, the Secretary shall give
priority to the development of quality measures that
allow the assessment of--
(A) health outcomes and functional status
of patients;
(B) the management and coordination of
health care across episodes of care and care
transitions for patients across the continuum
of providers, health care settings, and health
plans;
(C) the experience, quality, and use of
information provided to and used by patients,
caregivers, and authorized representatives to
inform decisionmaking about treatment options,
including the use of shared decisionmaking
tools and preference sensitive care (as defined
in section 936);
(D) the meaningful use of health
information technology;
(E) the safety, effectiveness, patient-
centeredness, appropriateness, and timeliness
of care;
(F) the efficiency of care;
(G) the equity of health services and
health disparities across health disparity
populations (as defined in section 485E) and
geographic areas;
(H) patient experience and satisfaction;
(I) the use of innovative strategies and
methodologies identified under section 933; and
(J) other areas determined appropriate by
the Secretary.
(3) Eligible entities.--To be eligible for a grant
or contract under this subsection, an entity shall--
(A) have demonstrated expertise and
capacity in the development and evaluation of
quality measures;
(B) have adopted procedures to include in
the quality measure development process--
(i) the views of those providers or
payers whose performance will be
assessed by the measure; and
(ii) the views of other parties who
also will use the quality measures
(such as patients, consumers, and
health care purchasers);
(C) collaborate with the entity with a
contract under section 1890(a) of the Social
Security Act and other stakeholders, as
practicable, and the Secretary so that quality
measures developed by the eligible entity will
meet the requirements to be considered for
endorsement by the entity with a contract under
such section 1890(a);
(D) have transparent policies regarding
governance and conflicts of interest; and
(E) submit an application to the Secretary
at such time and in such manner, as the
Secretary may require.
(4) Use of funds.--An entity that receives a grant,
contract, or agreement under this subsection shall use
such award to develop quality measures that meet the
following requirements:
(A) Such measures support measures required
to be reported under the Social Security Act,
where applicable, and in support of gaps and
existing quality measures that need
improvement, as described in subsection
(b)(1)(A).
(B) Such measures support measures
developed under section 1139A of the Social
Security Act and the Medicaid Quality
Measurement Program under section 1139B of such
Act, where applicable.
(C) To the extent practicable, data on such
quality measures is able to be collected using
health information technologies.
(D) Each quality measure is free of charge
to users of such measure.
(E) Each quality measure is publicly
available on an Internet website.
(d) Other Activities by the Secretary.--The Secretary may
use amounts available under this section to update and test,
where applicable, quality measures endorsed by the entity with
a contract under section 1890(a) of the Social Security Act or
adopted by the Secretary.
(e) Coordination of Grants.--The Secretary shall ensure
that grants or contracts awarded under this section are
coordinated with grants and contracts awarded under sections
1139A(5) and 1139B(4)(A) of the Social Security Act.
(f) Development of Outcome Measures.--
(1) In general.--The Secretary shall develop, and
periodically update (not less than every 3 years),
provider-level outcome measures for hospitals and
physicians, as well as other providers as determined
appropriate by the Secretary.
(2) Categories of measures.--The measures developed
under this subsection shall include, to the extent
determined appropriate by the Secretary--
(A) outcome measurement for acute and
chronic diseases, including, to the extent
feasible, the 5 most prevalent and resource-
intensive acute and chronic medical conditions;
and
(B) outcome measurement for primary and
preventative care, including, to the extent
feasible, measurements that cover provision of
such care for distinct patient populations
(such as healthy children, chronically ill
adults, or infirm elderly individuals).
(3) Goals.--In developing such measures, the
Secretary shall seek to--
(A) address issues regarding risk
adjustment, accountability, and sample size;
(B) include the full scope of services that
comprise a cycle of care; and
(C) include multiple dimensions.
(4) Timeframe.--
(A) Acute and chronic diseases.--Not later
than 24 months after the date of enactment of
this Act, the Secretary shall develop not less
than 10 measures described in paragraph (2)(A).
(B) Primary and preventive care.--Not later
than 36 months after the date of enactment of
this Act, the Secretary shall develop not less
than 10 measures described in paragraph (2)(B).
Subpart II--Health Care Quality Improvement Programs
SEC. 933. [299B-33] HEALTH CARE DELIVERY SYSTEM RESEARCH.
(a) Purpose.--The purposes of this section are to--
(1) enable the Director to identify, develop,
evaluate, disseminate, and provide training in
innovative methodologies and strategies for quality
improvement practices in the delivery of health care
services that represent best practices (referred to as
``best practices'') in health care quality, safety, and
value; and
(2) ensure that the Director is accountable for
implementing a model to pursue such research in a
collaborative manner with other related Federal
agencies.
(b) General Functions of the Center.--The Center for
Quality Improvement and Patient Safety of the Agency for
Healthcare Research and Quality (referred to in this section as
the ``Center''), or any other relevant agency or department
designated by the Director, shall--
(1) carry out its functions using research from a
variety of disciplines, which may include epidemiology,
health services, sociology, psychology, human factors
engineering, biostatistics, health economics, clinical
research, and health informatics;
(2) conduct or support activities consistent with
the purposes described in subsection (a), and for--
(A) best practices for quality improvement
practices in the delivery of health care
services; and
(B) that include changes in processes of
care and the redesign of systems used by
providers that will reliably result in intended
health outcomes, improve patient safety, and
reduce medical errors (such as skill
development for health care providers in team-
based health care delivery and rapid cycle
process improvement) and facilitate adoption of
improved workflow;
(3) identify health care providers, including
health care systems, single institutions, and
individual providers, that--
(A) deliver consistently high-quality,
efficient health care services (as determined
by the Secretary); and
(B) employ best practices that are
adaptable and scalable to diverse health care
settings or effective in improving care across
diverse settings;
(4) assess research, evidence, and knowledge about
what strategies and methodologies are most effective in
improving health care delivery;
(5) find ways to translate such information rapidly
and effectively into practice, and document the
sustainability of those improvements;
(6) create strategies for quality improvement
through the development of tools, methodologies, and
interventions that can successfully reduce variations
in the delivery of health care;
(7) identify, measure, and improve organizational,
human, or other causative factors, including those
related to the culture and system design of a health
care organization, that contribute to the success and
sustainability of specific quality improvement and
patient safety strategies;
(8) provide for the development of best practices
in the delivery of health care services that--
(A) have a high likelihood of success,
based on structured review of empirical
evidence;
(B) are specified with sufficient detail of
the individual processes, steps, training,
skills, and knowledge required for
implementation and incorporation into workflow
of health care practitioners in a variety of
settings;
(C) are designed to be readily adapted by
health care providers in a variety of settings;
and
(D) where applicable, assist health care
providers in working with other health care
providers across the continuum of care and in
engaging patients and their families in
improving the care and patient health outcomes;
(9) provide for the funding of the activities of
organizations with recognized expertise and excellence
in improving the delivery of health care services,
including children's health care, by involving multiple
disciplines, managers of health care entities, broad
development and training, patients, caregivers and
families, and frontline health care workers, including
activities for the examination of strategies to share
best quality improvement practices and to promote
excellence in the delivery of health care services; and
(10) build capacity at the State and community
level to lead quality and safety efforts through
education, training, and mentoring programs to carry
out the activities under paragraphs (1) through (9).
(c) Research Functions of Center.--
(1) In general.--The Center shall support, such as
through a contract or other mechanism, research on
health care delivery system improvement and the
development of tools to facilitate adoption of best
practices that improve the quality, safety, and
efficiency of health care delivery services. Such
support may include establishing a Quality Improvement
Network Research Program for the purpose of testing,
scaling, and disseminating of interventions to improve
quality and efficiency in health care. Recipients of
funding under the Program may include national, State,
multi-State, or multi-site quality improvement
networks.
(2) Research requirements.--The research conducted
pursuant to paragraph (1) shall--
(A) address the priorities identified by
the Secretary in the national strategic plan
established under section 399HH;
(B) identify areas in which evidence is
insufficient to identify strategies and
methodologies, taking into consideration areas
of insufficient evidence identified by the
entity with a contract under section 1890(a) of
the Social Security Act in the report required
under section 399JJ;
(C) address concerns identified by health
care institutions and providers and
communicated through the Center pursuant to
subsection (d);
(D) reduce preventable morbidity,
mortality, and associated costs of morbidity
and mortality by building capacity for patient
safety research;
(E) support the discovery of processes for
the reliable, safe, efficient, and responsive
delivery of health care, taking into account
discoveries from clinical research and
comparative effectiveness research;
(F) allow communication of research
findings and translate evidence into practice
recommendations that are adaptable to a variety
of settings, and which, as soon as practicable
after the establishment of the Center, shall
include--
(i) the implementation of a
national application of Intensive Care
Unit improvement projects relating to
the adult (including geriatric),
pediatric, and neonatal patient
populations;
(ii) practical methods for
addressing health care associated
infections, including Methicillin-
Resistant Staphylococcus Aureus and
Vancomycin-Resistant Entercoccus
infections and other emerging
infections; and
(iii) practical methods for
reducing preventable hospital
admissions and readmissions;
(G) expand demonstration projects for
improving the quality of children's health care
and the use of health information technology,
such as through Pediatric Quality Improvement
Collaboratives and Learning Networks,
consistent with provisions of section 1139A of
the Social Security Act for assessing and
improving quality, where applicable;
(H) identify and mitigate hazards by--
(i) analyzing events reported to
patient safety reporting systems and
patient safety organizations; and
(ii) using the results of such
analyses to develop scientific methods
of response to such events;
(I) include the conduct of systematic
reviews of existing practices that improve the
quality, safety, and efficiency of health care
delivery, as well as new research on improving
such practices; and
(J) include the examination of how to
measure and evaluate the progress of quality
and patient safety activities.
(d) Dissemination of Research Findings.--
(1) Public availability.--The Director shall make
the research findings of the Center available to the
public through multiple media and appropriate formats
to reflect the varying needs of health care providers
and consumers and diverse levels of health literacy.
(2) Linkage to health information technology.--The
Secretary shall ensure that research findings and
results generated by the Center are shared with the
Office of the National Coordinator of Health
Information Technology and used to inform the
activities of the health information technology
extension program under section 3012, as well as any
relevant standards, certification criteria, or
implementation specifications.
(e) Prioritization.--The Director shall identify and
regularly update a list of processes or systems on which to
focus research and dissemination activities of the Center,
taking into account--
(1) the cost to Federal health programs;
(2) consumer assessment of health care experience;
(3) provider assessment of such processes or
systems and opportunities to minimize distress and
injury to the health care workforce;
(4) the potential impact of such processes or
systems on health status and function of patients,
including vulnerable populations including children;
(5) the areas of insufficient evidence identified
under subsection (c)(2)(B); and
(6) the evolution of meaningful use of health
information technology, as defined in section 3000.
(f) Coordination.--The Center shall coordinate its
activities with activities conducted by the Center for Medicare
and Medicaid Innovation established under section 1115A of the
Social Security Act.
(g) Funding.--There is authorized to be appropriated to
carry out this section $20,000,000 for fiscal years 2010
through 2014.
SEC. 934. [299B-34] QUALITY IMPROVEMENT TECHNICAL ASSISTANCE AND
IMPLEMENTATION.
(a) In General.--The Director, through the Center for
Quality Improvement and Patient Safety of the Agency for
Healthcare Research and Quality (referred to in this section as
the ``Center''), shall award--
(1) technical assistance grants or contracts to
eligible entities to provide technical support to
institutions that deliver health care and health care
providers (including rural and urban providers of
services and suppliers with limited infrastructure and
financial resources to implement and support quality
improvement activities, providers of services and
suppliers with poor performance scores, and providers
of services and suppliers for which there are
disparities in care among subgroups of patients) so
that such institutions and providers understand, adapt,
and implement the models and practices identified in
the research conducted by the Center, including the
Quality Improvement Networks Research Program; and
(2) implementation grants or contracts to eligible
entities to implement the models and practices
described under paragraph (1).
(b) Eligible Entities.--
(1) Technical assistance award.--To be eligible to
receive a technical assistance grant or contract under
subsection (a)(1), an entity--
(A) may be a health care provider, health
care provider association, professional
society, health care worker organization,
Indian health organization, quality improvement
organization, patient safety organization,
local quality improvement collaborative, the
Joint Commission, academic health center,
university, physician-based research network,
primary care extension program established
under section 399V-1, a Federal Indian Health
Service program or a health program operated by
an Indian tribe (as defined in section 4 of the
Indian Health Care Improvement Act), or any
other entity identified by the Secretary; and
(B) shall have demonstrated expertise in
providing information and technical support and
assistance to health care providers regarding
quality improvement.
(2) Implementation award.--To be eligible to
receive an implementation grant or contract under
subsection (a)(2), an entity--
(A) may be a hospital or other health care
provider or consortium or providers, as
determined by the Secretary; and
(B) shall have demonstrated expertise in
providing information and technical support and
assistance to health care providers regarding
quality improvement.
(c) Application.--
(1) Technical assistance award.--To receive a
technical assistance grant or contract under subsection
(a)(1), an eligible entity shall submit an application
to the Secretary at such time, in such manner, and
containing--
(A) a plan for a sustainable business model
that may include a system of--
(i) charging fees to institutions
and providers that receive technical
support from the entity; and
(ii) reducing or eliminating such
fees for such institutions and
providers that serve low-income
populations; and
(B) such other information as the Director
may require.
(2) Implementation award.--To receive a grant or
contract under subsection (a)(2), an eligible entity
shall submit an application to the Secretary at such
time, in such manner, and containing--
(A) a plan for implementation of a model or
practice identified in the research conducted
by the Center including--
(i) financial cost, staffing
requirements, and timeline for
implementation; and
(ii) pre- and projected post-
implementation quality measure
performance data in targeted
improvement areas identified by the
Secretary; and
(B) such other information as the Director
may require.
(d) Matching Funds.--The Director may not award a grant or
contract under this section to an entity unless the entity
agrees that it will make available (directly or through
contributions from other public or private entities) non-
Federal contributions toward the activities to be carried out
under the grant or contract in an amount equal to $1 for each
$5 of Federal funds provided under the grant or contract. Such
non-Federal matching funds may be provided directly or through
donations from public or private entities and may be in cash or
in-kind, fairly evaluated, including plant, equipment, or
services.
(e) Evaluation.--
(1) In general.--The Director shall evaluate the
performance of each entity that receives a grant or
contract under this section. The evaluation of an
entity shall include a study of--
(A) the success of such entity in achieving
the implementation, by the health care
institutions and providers assisted by such
entity, of the models and practices identified
in the research conducted by the Center under
section 933;
(B) the perception of the health care
institutions and providers assisted by such
entity regarding the value of the entity; and
(C) where practicable, better patient
health outcomes and lower cost resulting from
the assistance provided by such entity.
(2) Effect of evaluation.--Based on the outcome of
the evaluation of the entity under paragraph (1), the
Director shall determine whether to renew a grant or
contract with such entity under this section.
(f) Coordination.--The entities that receive a grant or
contract under this section shall coordinate with health
information technology regional extension centers under section
3012(c) and the primary care extension program established
under section 399V-1 regarding the dissemination of quality
improvement, system delivery reform, and best practices
information.
SEC. 935. [299B-35] GRANTS OR CONTRACTS TO IMPLEMENT MEDICATION
MANAGEMENT SERVICES IN TREATMENT OF CHRONIC
DISEASES.
(a) In General.--The Secretary, acting through the Patient
Safety Research Center established in section 933 (referred to
in this section as the ``Center''), shall establish a program
to provide grants or contracts to eligible entities to
implement medication management (referred to in this section as
``MTM'') services provided by licensed pharmacists, as a
collaborative, multidisciplinary, inter-professional approach
to the treatment of chronic diseases for targeted individuals,
to improve the quality of care and reduce overall cost in the
treatment of such diseases. The Secretary shall commence the
program under this section not later than May 1, 2010.
(b) Eligible Entities.--To be eligible to receive a grant
or contract under subsection (a), an entity shall--
(1) provide a setting appropriate for MTM services,
as recommended by the experts described in subsection
(e);
(2) submit to the Secretary a plan for achieving
long-term financial sustainability;
(3) where applicable, submit a plan for
coordinating MTM services through local community
health teams established in section 3502 of the Patient
Protection and Affordable Care Act or in collaboration
with primary care extension programs established in
section 399V-1;
(4) submit a plan for meeting the requirements
under subsection (c); and
(5) submit to the Secretary such other information
as the Secretary may require.
(c) MTM Services to Targeted Individuals.--The MTM services
provided with the assistance of a grant or contract awarded
under subsection (a) shall, as allowed by State law including
applicable collaborative pharmacy practice agreements,
include--
(1) performing or obtaining necessary assessments
of the health and functional status of each patient
receiving such MTM services;
(2) formulating a medication treatment plan
according to therapeutic goals agreed upon by the
prescriber and the patient or caregiver or authorized
representative of the patient;
(3) selecting, initiating, modifying, recommending
changes to, or administering medication therapy;
(4) monitoring, which may include access to,
ordering, or performing laboratory assessments, and
evaluating the response of the patient to therapy,
including safety and effectiveness;
(5) performing an initial comprehensive medication
review to identify, resolve, and prevent medication-
related problems, including adverse drug events,
quarterly targeted medication reviews for ongoing
monitoring, and additional followup interventions on a
schedule developed collaboratively with the prescriber;
(6) documenting the care delivered and
communicating essential information about such care,
including a summary of the medication review, and the
recommendations of the pharmacist to other appropriate
health care providers of the patient in a timely
fashion;
(7) providing education and training designed to
enhance the understanding and appropriate use of the
medications by the patient, caregiver, and other
authorized representative;
(8) providing information, support services, and
resources and strategies designed to enhance patient
adherence with therapeutic regimens;
(9) coordinating and integrating MTM services
within the broader health care management services
provided to the patient; and
(10) such other patient care services allowed under
pharmacist scopes of practice in use in other Federal
programs that have implemented MTM services.
(d) Targeted Individuals.--MTM services provided by
licensed pharmacists under a grant or contract awarded under
subsection (a) shall be offered to targeted individuals who--
(1) take 4 or more prescribed medications
(including over-the-counter medications and dietary
supplements);
(2) take any ``high risk'' medications;
(3) have 2 or more chronic diseases, as identified
by the Secretary; or
(4) have undergone a transition of care, or other
factors, as determined by the Secretary, that are
likely to create a high risk of medication-related
problems.
(e) Consultation With Experts.--In designing and
implementing MTM services provided under grants or contracts
awarded under subsection (a), the Secretary shall consult with
Federal, State, private, public-private, and academic entities,
pharmacy and pharmacist organizations, health care
organizations, consumer advocates, chronic disease groups, and
other stakeholders involved with the research, dissemination,
and implementation of pharmacist-delivered MTM services, as the
Secretary determines appropriate. The Secretary, in
collaboration with this group, shall determine whether it is
possible to incorporate rapid cycle process improvement
concepts in use in other Federal programs that have implemented
MTM services.
(f) Reporting to the Secretary.--An entity that receives a
grant or contract under subsection (a) shall submit to the
Secretary a report that describes and evaluates, as requested
by the Secretary, the activities carried out under subsection
(c), including quality measures endorsed by the entity with a
contract under section 1890 of the Social Security Act, as
determined by the Secretary.
(g) Evaluation and Report.--The Secretary shall submit to
the relevant committees of Congress a report which shall--
(1) assess the clinical effectiveness of
pharmacist-provided services under the MTM services
program, as compared to usual care, including an
evaluation of whether enrollees maintained better
health with fewer hospitalizations and emergency room
visits than similar patients not enrolled in the
program;
(2) assess changes in overall health care resource
use by targeted individuals;
(3) assess patient and prescriber satisfaction with
MTM services;
(4) assess the impact of patient-cost sharing
requirements on medication adherence and
recommendations for modifications;
(5) identify and evaluate other factors that may
impact clinical and economic outcomes, including
demographic characteristics, clinical characteristics,
and health services use of the patient, as well as
characteristics of the regimen, pharmacy benefit, and
MTM services provided; and
(6) evaluate the extent to which participating
pharmacists who maintain a dispensing role have a
conflict of interest in the provision of MTM services,
and if such conflict is found, provide recommendations
on how such a conflict might be appropriately
addressed.
(h) Grants or Contracts To Fund Development of Performance
Measures.--The Secretary may, through the quality measure
development program under section 931 of the Public Health
Service Act, award grants or contracts to eligible entities for
the purpose of funding the development of performance measures
that assess the use and effectiveness of medication therapy
management services.
SEC. 936. [299B-36] PROGRAM TO FACILITATE SHARED DECISIONMAKING.
(a) Purpose.--The purpose of this section is to facilitate
collaborative processes between patients, caregivers or
authorized representatives, and clinicians that engages the
patient, caregiver or authorized representative in
decisionmaking, provides patients, caregivers or authorized
representatives with information about trade-offs among
treatment options, and facilitates the incorporation of patient
preferences and values into the medical plan.
(b) Definitions.--In this section:
(1) Patient decision aid.--The term ``patient
decision aid'' means an educational tool that helps
patients, caregivers or authorized representatives
understand and communicate their beliefs and
preferences related to their treatment options, and to
decide with their health care provider what treatments
are best for them based on their treatment options,
scientific evidence, circumstances, beliefs, and
preferences.
(2) Preference sensitive care.--The term
``preference sensitive care'' means medical care for
which the clinical evidence does not clearly support
one treatment option such that the appropriate course
of treatment depends on the values of the patient or
the preferences of the patient, caregivers or
authorized representatives regarding the benefits,
harms and scientific evidence for each treatment
option, the use of such care should depend on the
informed patient choice among clinically appropriate
treatment options.
(c) Establishment of Independent Standards for Patient
Decision Aids for Preference Sensitive Care.--
(1) Contract with entity to establish standards and
certify patient decision aids.--
(A) In general.--For purposes of supporting
consensus-based standards for patient decision
aids for preference sensitive care and a
certification process for patient decision aids
for use in the Federal health programs and by
other interested parties, the Secretary shall
have in effect a contract with the entity with
a contract under section 1890 of the Social
Security Act. Such contract shall provide that
the entity perform the duties described in
paragraph (2).
(B) Timing for first contract.--As soon as
practicable after the date of the enactment of
this section, the Secretary shall enter into
the first contract under subparagraph (A).
(C) Period of contract.--A contract under
subparagraph (A) shall be for a period of 18
months (except such contract may be renewed
after a subsequent bidding process).
(2) Duties.--The following duties are described in
this paragraph:
(A) Develop and identify standards for
patient decision aids.--The entity shall
synthesize evidence and convene a broad range
of experts and key stakeholders to develop and
identify consensus-based standards to evaluate
patient decision aids for preference sensitive
care.
(B) Endorse patient decision aids.--The
entity shall review patient decision aids and
develop a certification process whether patient
decision aids meet the standards developed and
identified under subparagraph (A). The entity
shall give priority to the review and
certification of patient decision aids for
preference sensitive care.
(d) Program To Develop, Update and Patient Decision Aids To
Assist Health Care Providers and Patients.--
(1) In general.--The Secretary, acting through the
Director, and in coordination with heads of other
relevant agencies, such as the Director of the Centers
for Disease Control and Prevention and the Director of
the National Institutes of Health, shall establish a
program to award grants or contracts--
(A) to develop, update, and produce patient
decision aids for preference sensitive care to
assist health care providers in educating
patients, caregivers, and authorized
representatives concerning the relative safety,
relative effectiveness (including possible
health outcomes and impact on functional
status), and relative cost of treatment or,
where appropriate, palliative care options;
(B) to test such materials to ensure such
materials are balanced and evidence based in
aiding health care providers and patients,
caregivers, and authorized representatives to
make informed decisions about patient care and
can be easily incorporated into a broad array
of practice settings; and
(C) to educate providers on the use of such
materials, including through academic
curricula.
(2) Requirements for patient decision aids.--
Patient decision aids developed and produced pursuant
to a grant or contract under paragraph (1)--
(A) shall be designed to engage patients,
caregivers, and authorized representatives in
informed decisionmaking with health care
providers;
(B) shall present up-to-date clinical
evidence about the risks and benefits of
treatment options in a form and manner that is
age-appropriate and can be adapted for
patients, caregivers, and authorized
representatives from a variety of cultural and
educational backgrounds to reflect the varying
needs of consumers and diverse levels of health
literacy;
(C) shall, where appropriate, explain why
there is a lack of evidence to support one
treatment option over another; and
(D) shall address health care decisions
across the age span, including those affecting
vulnerable populations including children.
(3) Distribution.--The Director shall ensure that
patient decision aids produced with grants or contracts
under this section are available to the public.
(4) Nonduplication of efforts.--The Director shall
ensure that the activities under this section of the
Agency and other agencies, including the Centers for
Disease Control and Prevention and the National
Institutes of Health, are free of unnecessary
duplication of effort.
(e) Grants To Support Shared Decisionmaking
Implementation.--
(1) In general.--The Secretary shall establish a
program to provide for the phased-in development,
implementation, and evaluation of shared decisionmaking
using patient decision aids to meet the objective of
improving the understanding of patients of their
medical treatment options.
(2) Shared decisionmaking resource centers.--
(A) In general.--The Secretary shall
provide grants for the establishment and
support of Shared Decisionmaking Resource
Centers (referred to in this subsection as
``Centers'') to provide technical assistance to
providers and to develop and disseminate best
practices and other information to support and
accelerate adoption, implementation, and
effective use of patient decision aids and
shared decisionmaking by providers.
(B) Objectives.--The objective of a Center
is to enhance and promote the adoption of
patient decision aids and shared decisionmaking
through--
(i) providing assistance to
eligible providers with the
implementation and effective use of,
and training on, patient decision aids;
and
(ii) the dissemination of best
practices and research on the
implementation and effective use of
patient decision aids.
(3) Shared decisionmaking participation grants.--
(A) In general.--The Secretary shall
provide grants to health care providers for the
development and implementation of shared
decisionmaking techniques and to assess the use
of such techniques.
(B) Preference.--In order to facilitate the
use of best practices, the Secretary shall
provide a preference in making grants under
this subsection to health care providers who
participate in training by Shared
Decisionmaking Resource Centers or comparable
training.
(C) Limitation.--Funds under this paragraph
shall not be used to purchase or implement use
of patient decision aids other than those
certified under the process identified in
subsection (c).
(4) Guidance.--The Secretary may issue guidance to
eligible grantees under this subsection on the use of
patient decision aids.
(f) Funding.--For purposes of carrying out this section
there are authorized to be appropriated such sums as may be
necessary for fiscal year 2010 and each subsequent fiscal year.
SEC. 937. [299B-37] DISSEMINATION AND BUILDING CAPACITY FOR RESEARCH.
(a) In General.--
(1) Dissemination.--The Office of Communication and
Knowledge Transfer (referred to in this section as the
``Office'') at the Agency for Healthcare Research and
Quality (or any other relevant office designated by
Agency for Healthcare Research and Quality), in
consultation with the National Institutes of Health,
shall broadly disseminate the research findings that
are published by the Patient Centered Outcomes Research
Institute established under section 1181(b) of the
Social Security Act (referred to in this section as the
``Institute'') and other government-funded research
relevant to comparative clinical effectiveness
research. The Office shall create informational tools
that organize and disseminate research findings for
physicians, health care providers, patients, payers,
and policy makers. The Office shall also develop a
publicly available resource database that collects and
contains government-funded evidence and research from
public, private, not-for profit, and academic sources.
(2) Requirements.--The Office shall provide for the
dissemination of the Institute's research findings and
government-funded research relevant to comparative
clinical effectiveness research to physicians, health
care providers, patients, vendors of health information
technology focused on clinical decision support,
appropriate professional associations, and Federal and
private health plans. Materials, forums, and media used
to disseminate the findings, informational tools, and
resource databases shall--
(A) include a description of considerations
for specific subpopulations, the research
methodology, and the limitations of the
research, and the names of the entities,
agencies, instrumentalities, and individuals
who conducted any research which was published
by the Institute; and
(B) not be construed as mandates,
guidelines, or recommendations for payment,
coverage, or treatment.
(b) Incorporation of Research Findings.--The Office, in
consultation with relevant medical and clinical associations,
shall assist users of health information technology focused on
clinical decision support to promote the timely incorporation
of research findings disseminated under subsection (a) into
clinical practices and to promote the ease of use of such
incorporation.
(c) Feedback.--The Office shall establish a process to
receive feedback from physicians, health care providers,
patients, and vendors of health information technology focused
on clinical decision support, appropriate professional
associations, and Federal and private health plans about the
value of the information disseminated and the assistance
provided under this section.
(d) Rule of Construction.--Nothing in this section shall
preclude the Institute from making its research findings
publicly available as required under section 1181(d)(8) of the
Social Security Act.
(e) Training of Researchers.--The Agency for Health Care
Research and Quality, in consultation with the National
Institutes of Health, shall build capacity for comparative
clinical effectiveness research by establishing a grant program
that provides for the training of researchers in the methods
used to conduct such research, including systematic reviews of
existing research and primary research such as clinical trials.
At a minimum, such training shall be in methods that meet the
methodological standards adopted under section 1181(d)(9) of
the Social Security Act.
(f) Building Data for Research.--The Secretary shall
provide for the coordination of relevant Federal health
programs to build data capacity for comparative clinical
effectiveness research, including the development and use of
clinical registries and health outcomes research data networks,
in order to develop and maintain a comprehensive, interoperable
data network to collect, link, and analyze data on outcomes and
effectiveness from multiple sources, including electronic
health records.
(g) Authority To Contract With the Institute.--Agencies and
instrumentalities of the Federal Government may enter into
agreements with the Institute, and accept and retain funds, for
the conduct and support of research described in this part,
provided that the research to be conducted or supported under
such agreements is authorized under the governing statutes of
such agencies and instrumentalities.
PART E--GENERAL PROVISIONS
SEC. 941. [299C] ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.
(a) Establishment.--There is established an advisory
council to be known as the National Advisory Council for
Healthcare Research and Quality.
(b) Duties.--
(1) In general.--The Advisory Council shall advise
the Secretary and the Director with respect to
activities proposed or undertaken to carry out the
mission of the Agency under section 901(b).
(2) Certain recommendations.--Activities of the
Advisory Council under paragraph (1) shall include
making recommendations to the Director regarding--
(A) priorities regarding health care
research, especially studies related to
quality, outcomes, cost and the utilization of,
and access to, health care services;
(B) the field of health care research and
related disciplines, especially issues related
to training needs, and dissemination of
information pertaining to health care quality;
and
(C) the appropriate role of the Agency in
each of these areas in light of private sector
activity and identification of opportunities
for public-private sector partnerships.
(c) Membership.--
(1) In general.--The Advisory Council shall, in
accordance with this subsection, be composed of
appointed members and ex officio members. All members
of the Advisory Council shall be voting members other
than the individuals designated under paragraph (3)(B)
as ex officio members.
(2) Appointed members.--The Secretary shall appoint
to the Advisory Council 21 appropriately qualified
individuals. At least 17 members of the Advisory
Council shall be representatives of the public who are
not officers or employees of the United States and at
least 1 member who shall be a specialist in the rural
aspects of 1 or more of the professions or fields
described in subparagraphs (A) through (G). The
Secretary shall ensure that the appointed members of
the Council, as a group, are representative of
professions and entities concerned with, or affected
by, activities under this title and under section 1142
of the Social Security Act. Of such members--
(A) three shall be individuals
distinguished in the conduct of research,
demonstration projects, and evaluations with
respect to health care;
(B) three shall be individuals
distinguished in the fields of health care
quality research or health care improvement;
(C) three shall be individuals
distinguished in the practice of medicine of
which at least one shall be a primary care
practitioner;
(D) three shall be individuals
distinguished in the other health professions;
(E) three shall be individuals either
representing the private health care sector,
including health plans, providers, and
purchasers or individuals distinguished as
administrators of health care delivery systems;
(F) three shall be individuals
distinguished in the fields of health care
economics, information systems, law, ethics,
business, or public policy; and
(G) three shall be individuals representing
the interests of patients and consumers of
health care.
(3) Ex officio members.--The Secretary shall
designate as ex officio members of the Advisory
Council--
(A) the Assistant Secretary for Health, the
Director of the National Institutes of Health,
the Director of the Centers for Disease Control
and Prevention, the Administrator of the
Centers for Medicare & Medicaid Services, the
Commissioner of the Food and Drug
Administration, the Director of the Office of
Personnel Management, the Assistant Secretary
of Defense (Health Affairs), and the Under
Secretary for Health of the Department of
Veterans Affairs; and
(B) such other Federal officials as the
Secretary may consider appropriate.
(d) Terms.--
(1) In general.--Members of the Advisory Council
appointed under subsection (c)(2) shall serve for a
term of 3 years.
(2) Staggered terms.--To ensure the staggered
rotation of one-third of the members of the Advisory
Council each year, the Secretary is authorized to
appoint the initial members of the Advisory Council for
terms of 1, 2, or 3 years.
(3) Service beyond term.--A member of the Council
appointed under subsection (c)(2) may continue to serve
after the expiration of the term of the members until a
successor is appointed.
(e) Vacancies.--If a member of the Advisory Council
appointed under subsection (c)(2) does not serve the full term
applicable under subsection (d), the individual appointed to
fill the resulting vacancy shall be appointed for the remainder
of the term of the predecessor of the individual.
(f) Chair.--The Director shall, from among the members of
the Advisory Council appointed under subsection (c)(2),
designate an individual to serve as the chair of the Advisory
Council.
(g) Meetings.--The Advisory Council shall meet not less
than once during each discrete 4-month period and shall
otherwise meet at the call of the Director or the chair.
(h) Compensation and Reimbursement of Expenses.--
(1) Appointed members.--Members of the Advisory
Council appointed under subsection (c)(2) shall receive
compensation for each day (including travel time)
engaged in carrying out the duties of the Advisory
Council unless declined by the member. Such
compensation may not be in an amount in excess of the
daily equivalent of the annual rate of basic pay
prescribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each
day during which such member is engaged in the
performance of the duties of the Advisory Council.
(2) Ex officio members.--Officials designated under
subsection (c)(3) as ex officio members of the Advisory
Council may not receive compensation for service on the
Advisory Council in addition to the compensation
otherwise received for duties carried out as officers
of the United States.
(i) Staff.--The Director shall provide to the Advisory
Council such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.
(j) Duration.--Notwithstanding section 14(a) of the Federal
Advisory Committee Act, the Advisory Council shall continue in
existence until otherwise provided by law.
SEC. 942. [299C-1] PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.
(a) Requirement of Review.--
(1) In general.--Appropriate technical and
scientific peer review shall be conducted with respect
to each application for a grant, cooperative agreement,
or contract under this title.
(2) Reports to director.--Each peer review group to
which an application is submitted pursuant to paragraph
(1) shall report its finding and recommendations
respecting the application to the Director in such form
and in such manner as the Director shall require.
(b) Approval as Precondition of Awards.--The Director may
not approve an application described in subsection (a)(1)
unless the application is recommended for approval by a peer
review group established under subsection (c).
(c) Establishment of Peer Review Groups.--
(1) In general.--The Director shall establish such
technical and scientific peer review groups as may be
necessary to carry out this section. Such groups shall
be established without regard to the provisions of
title 5, United States Code, that govern appointments
in the competitive service, and without regard to the
provisions of chapter 51, and subchapter III of chapter
53, of such title that relate to classification and pay
rates under the General Schedule.
(2) Membership.--The members of any peer review
group established under this section shall be appointed
from among individuals who by virtue of their training
or experience are eminently qualified to carry out the
duties of such peer review group. Officers and
employees of the United States may not constitute more
than 25 percent of the membership of any such group.
Such officers and employees may not receive
compensation for service on such groups in addition to
the compensation otherwise received for these duties
carried out as such officers and employees.
(3) Duration.--Notwithstanding section 14(a) of the
Federal Advisory Committee Act, peer review groups
established under this section may continue in
existence until otherwise provided by law.
(4) Qualifications.--Members of any peer review
group shall, at a minimum, meet the following
requirements:
(A) Such members shall agree in writing to
treat information received, pursuant to their
work for the group, as confidential
information, except that this subparagraph
shall not apply to public records and public
information.
(B) Such members shall agree in writing to
recuse themselves from participation in the
peer review of specific applications which
present a potential personal conflict of
interest or appearance of such conflict,
including employment in a directly affected
organization, stock ownership, or any financial
or other arrangement that might introduce bias
in the process of peer review.
(d) Authority for Procedural Adjustments in Certain
Cases.--In the case of applications for financial assistance
whose direct costs will not exceed $100,000, the Director may
make appropriate adjustments in the procedures otherwise
established by the Director for the conduct of peer review
under this section. Such adjustments may be made for the
purpose of encouraging the entry of individuals into the field
of research, for the purpose of encouraging clinical practice-
oriented or provider-based research, and for such other
purposes as the Director may determine to be appropriate.
(e) Regulations.--The Director shall issue regulations for
the conduct of peer review under this section.
SEC. 943. [299C-2] CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT,
COLLECTION, AND DISSEMINATION OF DATA.
(a) Standards With Respect to Utility of Data.--
(1) In general.--To ensure the utility, accuracy,
and sufficiency of data collected by or for the Agency
for the purpose described in section 901(b), the
Director shall establish standard methods for
developing and collecting such data, taking into
consideration--
(A) other Federal health data collection
standards; and
(B) the differences between types of health
care plans, delivery systems, health care
providers, and provider arrangements.
(2) Relationship with other department programs.--
In any case where standards under paragraph (1) may
affect the administration of other programs carried out
by the Department of Health and Human Services,
including the programs under title XVIII, XIX or XXI of
the Social Security Act, or may affect health
information that is subject to a standard developed
under part C of title XI of the Social Security Act,
they shall be in the form of recommendations to the
Secretary for such program.
(b) Statistics and Analyses.--The Director shall--
(1) take appropriate action to ensure that
statistics and analyses developed under this title are
of high quality, timely, and duly comprehensive, and
that the statistics are specific, standardized, and
adequately analyzed and indexed; and
(2) publish, make available, and disseminate such
statistics and analyses on as wide a basis as is
practicable.
(c) Authority Regarding Certain Requests.--Upon request of
a public or private entity, the Director may conduct or support
research or analyses otherwise authorized by this title
pursuant to arrangements under which such entity will pay the
cost of the services provided. Amounts received by the Director
under such arrangements shall be available to the Director for
obligation until expended.
SEC. 944. [299C-3] DISSEMINATION OF INFORMATION.
(a) In General.--The Director shall--
(1) without regard to section 501 of title 44,
United States Code, promptly publish, make available,
and otherwise disseminate, in a form understandable and
on as broad a basis as practicable so as to maximize
its use, the results of research, demonstration
projects, and evaluations conducted or supported under
this title;
(2) ensure that information disseminated by the
Agency is science-based and objective and undertakes
consultation as necessary to assess the appropriateness
and usefulness of the presentation of information that
is targeted to specific audiences;
(3) promptly make available to the public data
developed in such research, demonstration projects, and
evaluations;
(4) provide, in collaboration with the National
Library of Medicine where appropriate, indexing,
abstracting, translating, publishing, and other
services leading to a more effective and timely
dissemination of information on research, demonstration
projects, and evaluations with respect to health care
to public and private entities and individuals engaged
in the improvement of health care delivery and the
general public, and undertake programs to develop new
or improved methods for making such information
available; and
(5) as appropriate, provide technical assistance to
State and local government and health agencies and
conduct liaison activities to such agencies to foster
dissemination.
(b) Prohibition Against Restrictions.--Except as provided
in subsection (c), the Director may not restrict the
publication or dissemination of data from, or the results of,
projects conducted or supported under this title.
(c) Limitation on Use of Certain Information.--No
information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the
course of activities undertaken or supported under this title
may be used for any purpose other than the purpose for which it
was supplied unless such establishment or person has consented
(as determined under regulations of the Director) to its use
for such other purpose. Such information may not be published
or released in other form if the person who supplied the
information or who is described in it is identifiable unless
such person has consented (as determined under regulations of
the Director) to its publication or release in other form.
(d) Penalty.--Any person who violates subsection (c) shall
be subject to a civil monetary penalty of not more than $10,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security Act are
imposed and collected.
SEC. 945. [299C-4] ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND
CONTRACTS.
(a) Financial Conflicts of Interest.--With respect to
projects for which awards of grants, cooperative agreements, or
contracts are authorized to be made under this title, the
Director shall by regulation define--
(1) the specific circumstances that constitute
financial interests in such projects that will, or may
be reasonably expected to, create a bias in favor of
obtaining results in the projects that are consistent
with such interests; and
(2) the actions that will be taken by the Director
in response to any such interests identified by the
Director.
(b) Requirement of Application.--The Director may not, with
respect to any program under this title authorizing the
provision of grants, cooperative agreements, or contracts,
provide any such financial assistance unless an application for
the assistance is submitted to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Director determines to be necessary to carry out the program
involved.
(c) Provision of Supplies and Services in Lieu of Funds.--
(1) In general.--Upon the request of an entity
receiving a grant, cooperative agreement, or contract
under this title, the Secretary may, subject to
paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the entity in
carrying out the project involved and, for such
purpose, may detail to the entity any officer or
employee of the Department of Health and Human
Services.
(2) Corresponding reduction in funds.--With respect
to a request described in paragraph (1), the Secretary
shall reduce the amount of the financial assistance
involved by an amount equal to the costs of detailing
personnel and the fair market value of any supplies,
equipment, or services provided by the Director. The
Secretary shall, for the payment of expenses incurred
in complying with such request, expend the amounts
withheld.
(d) Applicability of Certain Provisions With Respect to
Contracts.--Contracts may be entered into under this part
without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529 and 41 U.S.C. 5).
SEC. 946. [299C-5] CERTAIN ADMINISTRATIVE AUTHORITIES.
(a) Deputy Director and Other Officers and Employees.--
(1) Deputy director.--The Director may appoint a
deputy director for the Agency.
(2) Other officers and employees.--The Director may
appoint and fix the compensation of such officers and
employees as may be necessary to carry out this title.
Except as otherwise provided by law, such officers and
employees shall be appointed in accordance with the
civil service laws and their compensation fixed in
accordance with title 5, United States Code.
(b) Facilities.--The Secretary, in carrying out this
title--
(1) may acquire, without regard to the Act of March
3, 1877 (40 U.S.C. 34), by lease or otherwise through
the Administrator of General Services, buildings or
portions of buildings in the District of Columbia or
communities located adjacent to the District of
Columbia for use for a period not to exceed 10 years;
and
(2) may acquire, construct, improve, repair,
operate, and maintain laboratory, research, and other
necessary facilities and equipment, and such other real
or personal property (including patents) as the
Secretary deems necessary.
(c) Provision of Financial Assistance.--The Director, in
carrying out this title, may make grants to public and
nonprofit entities and individuals, and may enter into
cooperative agreements or contracts with public and private
entities and individuals.
(d) Utilization of Certain Personnel and Resources.--
(1) Department of health and human services.--The
Director, in carrying out this title, may utilize
personnel and equipment, facilities, and other physical
resources of the Department of Health and Human
Services, permit appropriate (as determined by the
Secretary) entities and individuals to utilize the
physical resources of such Department, and provide
technical assistance and advice.
(2) Other agencies.--The Director, in carrying out
this title, may use, with their consent, the services,
equipment, personnel, information, and facilities of
other Federal, State, or local public agencies, or of
any foreign government, with or without reimbursement
of such agencies.
(e) Consultants.--The Secretary, in carrying out this
title, may secure, from time to time and for such periods as
the Director deems advisable but in accordance with section
3109 of title 5, United States Code, the assistance and advice
of consultants from the United States or abroad.
(f) Experts.--
(1) In general.--The Secretary may, in carrying out
this title, obtain the services of not more than 50
experts or consultants who have appropriate scientific
or professional qualifications. Such experts or
consultants shall be obtained in accordance with
section 3109 of title 5, United States Code, except
that the limitation in such section on the duration of
service shall not apply.
(2) Travel expenses.--
(A) In general.--Experts and consultants
whose services are obtained under paragraph (1)
shall be paid or reimbursed for their expenses
associated with traveling to and from their
assignment location in accordance with sections
5724, 5724a(a), 5724a(c), and 5726(c) of title
5, United States Code.
(B) Limitation.--Expenses specified in
subparagraph (A) may not be allowed in
connection with the assignment of an expert or
consultant whose services are obtained under
paragraph (1) unless and until the expert
agrees in writing to complete the entire period
of assignment, or 1 year, whichever is shorter,
unless separated or reassigned for reasons that
are beyond the control of the expert or
consultant and that are acceptable to the
Secretary. If the expert or consultant violates
the agreement, the money spent by the United
States for the expenses specified in
subparagraph (A) is recoverable from the expert
or consultant as a statutory obligation owed to
the United States. The Secretary may waive in
whole or in part a right of recovery under this
subparagraph.
(g) Voluntary and Uncompensated Services.--The Director, in
carrying out this title, may accept voluntary and uncompensated
services.
SEC. 947. [299C-6] FUNDING.
(a) Intent.--To ensure that the United States investment in
biomedical research is rapidly translated into improvements in
the quality of patient care, there must be a corresponding
investment in research on the most effective clinical and
organizational strategies for use of these findings in daily
practice. The authorization levels in subsections (b) and (c)
provide for a proportionate increase in health care research as
the United States investment in biomedical research increases.
(b) Authorization of Appropriations.--For the purpose of
carrying out this title, there are authorized to be
appropriated $250,000,000 for fiscal year 2000, and such sums
as may be necessary for each of the fiscal years 2001 through
2005.
(c) Evaluations.--In addition to amounts available pursuant
to subsection (b) for carrying out this title, there shall be
made available for such purpose, from the amounts made
available pursuant to section 241 (relating to evaluations), an
amount equal to 40 percent of the maximum amount authorized in
such section 241 to be made available for a fiscal year.
(d) Health Disparities Research.--For the purpose of
carrying out the activities under section 903, there are
authorized to be appropriated $50,000,000 for fiscal year 2001,
and such sums as may be necessary for each of the fiscal years
2002 through 2005.
(e) Patient Safety and Quality Improvement.--For the
purpose of carrying out part C, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2006 through 2010.
SEC. 948. [299C-7] DEFINITIONS.
In this title:
(1) Advisory council.--The term ``Advisory
Council'' means the National Advisory Council on
Healthcare Research and Quality established under
section 941.
(2) Agency.--The term ``Agency'' means the Agency
for Healthcare Research and Quality.
(3) Director.--The term ``Director'' means the
Director of the Agency for Healthcare Research and
Quality.
TITLE X--POPULATION RESEARCH AND VOLUNTARY FAMILY PLANNING PROGRAMS
project grants and contracts for family planning services
Sec. 1001. [300] (a) The Secretary is authorized to make
grants to and enter into contracts with public or nonprofit
private entities to assist in the establishment and operation
of voluntary family planning projects which shall offer a broad
range of acceptable and effective family planning methods and
services (including natural family planning methods,
infertility services, and services for adolescents). To the
extent practicable, entities which receive grants or contracts
under this subsection shall encourage familiy \1\ participation
in projects assisted under this subsection.
---------------------------------------------------------------------------
\1\ So in law. See section 931(b)(1) of Public Law 97-35 (95 Stat.
570). Probably should be ``family''.
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(b) In making grants and contracts under this section the
Secretary shall take into account the number of patients to be
served, the extent to which family planning services are needed
locally, the relative need of the applicant, and its capacity
to make rapid and effective use of such assistance. Local and
regional entities shall be assured the right to apply for
direct grants and contracts under this section, and the
Secretary shall by regulation fully provide for and protect
such right.
(c) The Secretary, at the request of a recipient of a grant
under subsection (a), may reduce the amount of such grant by
the fair market value of any supplies or equipment furnished
the grant recipient by the Secretary. The amount by which any
such grant is so reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the supplies or
equipment on which the reduction of such grant is based. Such
amount shall be deemed as part of the grant and shall be deemed
to have been paid to the grant recipient.
(d) For the purpose of making grants and contracts under
this section, there are authorized to be appropriated
$30,000,000 for the fiscal year ending June 30, 1971;
$60,000,000 for the fiscal year ending June 30, 1972;
$111,500,000 for the fiscal year ending June 30, 1973;
$111,500,000 each for the fiscal years ending June 30, 1974,
and June 30, 1975; $115,000,000 for fiscal year 1976;
$115,000,000 for the fiscal year ending September 30, 1977;
$136,400,000 for the fiscal year ending September 30, 1978;
$200,000,000 for the fiscal year ending September 30, 1979;
$230,000,000 for the fiscal year ending September 30, 1980;
$264,500,000 for the fiscal year ending September 30, 1981;
$126,510,000 for the fiscal year ending September 30, 1982;
$139,200,000 for the fiscal year ending September 30, 1983;
$150,030,000 for the fiscal year ending September 30, 1984; and
$158,400,000 for the fiscal year ending September 30, 1985.
formula grants to states for family planning services
Sec. 1002. [300a] (a) The Secretary is authorized to make
grants, from allotments made under subsection (b), to State
health authorities to assist in planning, establishing,
maintaining, coordinating, and evaluating family planning
services. No grant may be made to a State health authority
under this section unless such authority has submitted, and had
approved by the Secretary, a State plan for a coordinated and
comprehensive program of family planning services.
(b) The sums appropriated to carry out the provisions of
this section shall be allotted to the States by the Secretary
on the basis of the population and the financial need of the
respective States.
(c) For the purposes of this section, the term ``State''
includes the Commonwealth of Puerto Rico, the Northern Mariana
Islands, Guam, American Samoa, the Virgin Islands, the District
of Columbia, and the Trust Territory of the Pacific Islands.
(d) For the purpose of making grants under this section,
there are authorized to be appropriated $10,000,000 for the
fiscal year ending June 30, 1971; $15,000,000 for the fiscal
year ending June 30, 1972; and $20,000,000 for the fiscal year
ending June 30, 1973.
training grants and contracts
Sec. 1003. [300a-1] (a) The Secretary is authorized to make
grants to public or nonprofit private entities and to enter
into contracts with public or private entities and individuals
to provide the training for personnel to carry out family
planning service programs described in section 1001 or 1002.
(b) For the purpose of making payments pursuant to grants
and contracts under this section, there are authorized to be
appropriated $2,000,000 for the fiscal year ending June 30,
1971; $3,000,000 for the fiscal year ending June 30, 1972;
$4,000,000 for the fiscal year ending June 30, 1973; and
$3,000,000 each for the fiscal years ending June 30, 1974, and
June 30, 1975; $4,000,000 for fiscal year 1976; $5,000,000 for
the fiscal year ending September 30, 1977; $3,000,000 for the
fiscal year ending September 30, 1978; $3,100,000 for the
fiscal year ending September 30, 1979; $3,600,000 for the
fiscal year ending September 30, 1980; $4,100,000 for the
fiscal year ending September 30, 1981; $2,920,000 for the
fiscal year ending September 30, 1982; $3,200,000 for the
fiscal year ending September 30, 1983; $3,500,000 for the
fiscal year ending September 30, 1984; and $3,500,000 for the
fiscal year ending September 30, 1985.
research
Sec. 1004. [300a-2] The Secretary may--
(1) conduct, and
(2) make grants to public or nonprofit private
entities and enter into contracts with public or
private entities and individuals for projects for,
research in the biomedical, contraceptive development,
behavioral, and program implementation fields related to family
planning and population.
informational and educational materials
Sec. 1005. [300a-3] (a) The Secretary is authorized to make
grants to public or nonprofit private entities and to enter
into contracts with public or private entities and individuals
to assist in developing and making available family planning
and population growth information (including educational
materials) to all persons desiring such information (or
materials).
(b) For the purpose of making payments pursuant to grants
and contracts under this section, there are authorized to be
appropriated $750,000 for the fiscal year ending June 30, 1971;
$1,000,000 for the fiscal year ending June 30, 1972; $1,250,000
for the fiscal year ending June 30, 1973; $909,000 each for the
fiscal years ending June 30, 1974, and June 30, 1975;
$2,000,000 for fiscal year 1976; $2,500,000 for the fiscal year
ending September 30, 1977; $600,000 for the fiscal year ending
September 30, 1978; $700,000 for the fiscal year ending
September 30, 1979; $805,000 for the fiscal year ending
September 30, 1980; $926,000 for the fiscal year ending
September 30, 1981; $570,000 for the fiscal year ending
September 30, 1982; $600,000 for the fiscal year ending
September 30, 1983; $670,000 for the fiscal year ending
September 30, 1984; and $700,000 for the fiscal year ending
September 30, 1985.
regulations and payments
Sec. 1006. [300a-4] (a) Grants and contracts made under
this title shall be made in accordance with such regulations as
the Secretary may promulgate. The amount of any grant under any
section of this title shall be determined by the Secretary;
except that no grant under any such section for any program or
project for a fiscal year beginning after June 30, 1975, may be
made for less than 90 per centum of its costs (as determined
under regulations of the Secretary) unless the grant is to be
made for a program or project for which a grant was made (under
the same section) for the fiscal year ending June 30, 1975, for
less than 90 per centum of its costs (as so determined), in
which case a grant under such section for that program or
project for a fiscal year beginning after that date may be made
for a percentage which shall not be less than the percentage of
its costs for which the fiscal year 1975 grant was made.
(b) Grants under this title shall be payable in such
installments and subject to such conditions as the Secretary
may determine to be appropriate to assure that such grants will
be effectively utilized for the purposes for which made.
(c) A grant may be made or contract entered into under
section 1001 or 1002 for a family planning service project or
program only upon assurances satisfactory to the Secretary
that--
(1) priority will be given in such project or
program to the furnishing of such services to persons
from low-income families; and
(2) no charge will be made in such project or
program for services provided to any person from a low-
income family except to the extent that payment will be
made by a third party (including a government agency)
which is authorized or is under legal obligation to pay
such charge.
For purposes of this subsection, the term ``low-income family''
shall be defined by the Secretary in accordance with such
criteria as he may prescribe so as to insure that economic
status shall not be a deterrent to participation in the
programs assisted under this title.
(d)(1) A grant may be made or a contract entered into under
section 1001 or 1005 only upon assurances satisfactory to the
Secretary that informational or educational materials developed
or made available under the grant or contract will be suitable
for the purposes of this title and for the population or
community to which they are to be made available, taking into
account the educational and cultural background of the
individuals to whom such materials are addressed and the
standards of such population or community with respect to such
materials.
(2) In the case of any grant or contract under section
1001, such assurances shall provide for the review and approval
of the suitability of such materials, prior to their
distribution, by an advisory committee established by the
grantee or contractor in accordance with the Secretary's
regulations. Such a committee shall include individuals broadly
representative of the population or community to which the
materials are to be made available.
voluntary participation
Sec. 1007. [300a-5] The acceptance by any individual of
family planning services or family planning or population
growth information (including educational materials) provided
through financial assistance under this title (whether by grant
or contract) shall be voluntary and shall not be a prerequisite
to eligibility for or receipt of any other service or
assistance from, or to participation in, any other program of
the entity or individual that provided such service or
information.
prohibition of abortion
Sec. 1008. \1\ [300a-6] None of the funds appropriated
under this title shall be used in programs where abortion is a
method of family planning.
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\1\ Section 1009 was repealed by section 601(a)(1)(G) of Public Law
105-362 (112 Stat. 3285).
TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT
DEATH SYNDROME
Part A--Genetic Diseases
research project grants and contracts
Sec. 1102. [300b-1] In carrying out section 301, the
Secretary, may make grants to public and nonprofit private
entities, and may enter into contracts with public and private
entities and individuals, for projects for (1) basic or applied
research leading to the understanding, diagnosis, treatment,
and control of genetic diseases, (2) planning, establishing,
demonstrating, and developing special programs for the training
of genetic counselors, social and behavioral scientists, and
other health professionals, (3) the development of programs to
educate practicing physicians, other health professionals and
the public regarding the nature of genetic processes, the
inheritance patterns of genetic diseases, and the means,
methods, and facilities available to diagnose, control,
counsel, and treat genetic diseases, and (4) the development of
counseling and testing programs and other programs for the
diagnosis, control, and treatment of genetic diseases. In
making grants and entering into contracts for projects
described in clause (1) of the preceding sentence, the
Secretary shall give priority to applications for such grants
or contracts which are submitted for research on sickle cell
anemia and for research on Cooley's anemia.
voluntary participation
Sec. 1103. [300b-2] The participation by any individual in
any program or portion thereof under this part shall be wholly
voluntary and shall not be a prerequisite to eligibility for or
receipt of any other service or assistance from, or to
participation in, any other program.
application; administration of grants and contract programs
Sec. 1104. [300b-3] (a) A grant or contract under this part
may be made upon application submitted to the Secretary at such
time, in such manner, and containing and accompanied by such
information, as the Secretary may require including assurances
for an evaluation whether performed by the applicant or by the
Secretary. Such grant or contract may be made available on less
than a state-wide or regional basis. Each applicant shall--
(1) provide that the programs and activities for
which assistance under this part is sought will be
administered by or under the supervision of the
applicant;
(2) provide for strict confidentiality of all test
results, medical records, and other information
regarding testing, diagnosis, counseling, or treatment
of any person treated, except for (A) such information
as the patient (or his guardian) gives informed consent
to be released, or (B) statistical data compiled
without reference to the identity of any such patient;
(3) provide for community representation where
appropriate in the development and operation of
voluntary genetic testing or counseling programs funded
by a grant or contract under this part; and
(4) establish fiscal control and fund accounting
procedures as may be necessary to assure proper
disbursement of and accounting of Federal funds paid to
the applicant under this part.
(b) In making grants and entering into contracts for any
fiscal year under section 301 for projects described in section
1102 the Secretary shall give special consideration to
applications from entities that received grants from, or
entered into contracts with, the Secretary for the preceding
fiscal year for the conduct of comprehensive sickle cell
centers or sickle cell screening and education clinics.
public health service facilities
Sec. 1105. [300b-4] The Secretary shall establish a program
within the Service to provide voluntary testing, diagnosis,
counseling, and treatment of individuals respecting genetic
diseases. Services under such program shall be made available
through facilities of the Service to persons requesting such
services, and the program shall provide appropriate publicity
of the availability and voluntary nature of such services.
Sec. 1106. [Repealed].
applied technology
Sec. 1107. [300b-6] The Secretary, acting through an
identifiable administrative unit, shall--
(1) conduct epidemiological assessments and
surveillance of genetic diseases to define the scope
and extent of such diseases and the need for programs
for the diagnosis, treatment, and control of such
diseases, screening for such diseases, and the
counseling of persons with such diseases;
(2) on the basis of the assessments and
surveillance described in paragraph (1), develop for
use by the States programs which combine in an
effective manner diagnosis, treatment, and control of
such diseases, screening for such diseases, and
counseling of persons with such diseases; and
(3) on the basis of the assessments and
surveillance described in paragraph (1), provide
technical assistance to States to implement the
programs developed under paragraph (2) and train
appropriate personnel for such programs.
In carrying out this section, the Secretary may, from funds
allotted for use under section 502(a) of the Social Security
Act, make grants to or contracts with public or nonprofit
private entities (including grants and contracts for
demonstration projects).
tourette syndrome
Sec. 1108. [300b-7] (a) In General.--The Secretary shall
develop and implement outreach programs to educate the public,
health care providers, educators and community based
organizations about the etiology, symptoms, diagnosis and
treatment of Tourette Syndrome, with a particular emphasis on
children with Tourette Syndrome. Such programs may be carried
out by the Secretary directly and through awards of grants or
contracts to public or nonprofit private entities.
(b) Certain Activities.--Activities under subsection (a)
shall include--
(1) the production and translation of educational
materials, including public service announcements;
(2) the development of training material for health
care providers, educators and community based
organizations; and
(3) outreach efforts directed at the misdiagnosis
and underdiagnosis of Tourette Syndrome in children and
in minority groups.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005.
SEC. 1109. [300B-8] IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDERS.
(a) Authorization of Grant Program.--From amounts
appropriated under subsection (j), the Secretary, acting
through the Administrator of the Health Resources and Services
Administration (referred to in this section as the
``Administrator'') and in consultation with the Advisory
Committee on Heritable Disorders in Newborns and Children
(referred to in this section as the ``Advisory Committee''),
shall award grants to eligible entities to enable such
entities--
(1) to enhance, improve or expand the ability of
State and local public health agencies to provide
screening, counseling, or health care services to
newborns and children having or at risk for heritable
disorders;
(2) to assist in providing health care
professionals and newborn screening laboratory
personnel with education in newborn screening and
training in relevant and new technologies in newborn
screening and congenital, genetic, and metabolic
disorders;
(3) to develop and deliver educational programs (at
appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, and
specialty services to parents, families, and patient
advocacy and support groups; and
(4) to establish, maintain, and operate a system to
assess and coordinate treatment relating to congenital,
genetic, and metabolic disorders.
(b) Eligible Entity.--In this section, the term ``eligible
entity'' means--
(1) a State or a political subdivision of a State;
(2) a consortium of 2 or more States or political
subdivisions of States;
(3) a territory;
(4) a health facility or program operated by or
pursuant to a contract with or grant from the Indian
Health Service; or
(5) any other entity with appropriate expertise in
newborn screening, as determined by the Secretary.
(c) Approval Factors.--An application submitted for a grant
under subsection (a)(1) shall not be approved by the Secretary
unless the application contains assurances that the eligible
entity has adopted and implemented, is in the process of
adopting and implementing, or will use amounts received under
such grant to adopt and implement the guidelines and
recommendations of the Advisory Committee that are adopted by
the Secretary and in effect at the time the grant is awarded or
renewed under this section, which shall include the screening
of each newborn for the heritable disorders recommended by the
Advisory Committee and adopted by the Secretary.
(d) Coordination.--The Secretary shall take all necessary
steps to coordinate programs funded with grants received under
this section and to coordinate with existing newborn screening
activities.
(e) Limitation.--An eligible entity may not use amounts
received under this section to--
(1) provide cash payments to or on behalf of
affected individuals;
(2) provide inpatient services;
(3) purchase land or make capital improvements to
property; or
(4) provide for proprietary research or training.
(f ) Voluntary Participation.--The participation by any
individual in any program or portion thereof established or
operated with funds received under this section shall be wholly
voluntary and shall not be a prerequisite to eligibility for or
receipt of any other service or assistance from, or to
participation in, another Federal or State program.
(g) Supplement Not Supplant.--Funds appropriated under this
section shall be used to supplement and not supplant other
Federal, State, and local public funds provided for activities
of the type described in this section.
(h) Publication.--
(1) In general.--An application submitted under
subsection (c)(2) \1\ shall be made public by the State
in such a manner as to facilitate comment from any
person, including through hearings and other methods
used to facilitate comments from the public.
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\1\ Subsection (c)(2) was stricken by section 2(1) of the Newborn
Screening Saves Lives Act of 2007 (Public Law 110-204).
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(2) Comments.--Comments received by the State after
the publication described in paragraph (1) shall be
addressed in the application submitted under subsection
(c)(2) \1\.
(i) Technical Assistance.--The Secretary shall provide to
entities receiving grants under subsection (a) such technical
assistance as may be necessary to ensure the quality of
programs conducted under this section.
(j) Authorization of Appropriations.--There are authorized
to be appropriated--
(1) to provide grants for the purpose of carrying
out activities under subsection (a)(1), $15,000,000 for
fiscal year 2009; \1\ $15,187,500 for fiscal year 2010,
$15,375,000 for fiscal year 2011, $15,562,500 for
fiscal year 2012, and $15,750,000 for fiscal year 2013;
and
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\1\ So in law. The semicolon after the dollar amount for fiscal
year 2009 should be a comma.
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(2) to provide grants for the purpose of carrying
out activities under paragraphs (2), (3), and (4) of
subsection (a), $15,000,000 for fiscal year 2009,
$15,187,500 for fiscal year 2010, $15,375,000 for
fiscal year 2011, $15,562,500 for fiscal year 2012, and
$15,750,000 for fiscal year 2013.
SEC. 1110. [300B-9] EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD
SCREENING PROGRAMS.
(a) In General.--The Secretary shall award grants to
eligible entities to provide for the conduct of demonstration
programs to evaluate the effectiveness of screening, counseling
or health care services in reducing the morbidity and mortality
caused by heritable disorders in newborns and children.
(b) Demonstration Programs.--A demonstration program
conducted under a grant under this section shall be designed to
evaluate and assess, within the jurisdiction of the entity
receiving such grant--
(1) the effectiveness of screening, counseling,
testing or specialty services for newborns and children
at risk for heritable disorders in reducing the
morbidity and mortality associated with such disorders;
(2) the effectiveness of screening, counseling,
testing or specialty services in accurately and
reliably diagnosing heritable disorders in newborns and
children; or
(3) the availability of screening, counseling,
testing or specialty services for newborns and children
at risk for heritable disorders.
(c) Eligible Entities.--To be eligible to receive a grant
under subsection (a) an entity shall be a State or political
subdivision of a State, or a consortium of two or more States
or political subdivisions of States.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $5,000,000 for
fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000
for fiscal year 2011, $5,187,500 for fiscal year 2012, and
$5,250,000 for fiscal year 2013.
SEC. 1111. [300B-10] ADVISORY COMMITTEE ON HERITABLE DISORDERS IN
NEWBORNS AND CHILDREN.
(a) Establishment.--The Secretary shall establish an
advisory committee to be known as the ``Advisory Committee on
Heritable Disorders in Newborns and Children'' (referred to in
this section as the ``Advisory Committee'').
(b) Duties.--The Advisory Committee shall--
(1) provide advice and recommendations to the
Secretary concerning grants and projects awarded or
funded under section 1109;
(2) provide technical information to the Secretary
for the development of policies and priorities for the
administration of grants under section 1109;
(3) make systematic evidence-based and peer-
reviewed recommendations that include the heritable
disorders that have the potential to significantly
impact public health for which all newborns should be
screened, including secondary conditions that may be
identified as a result of the laboratory methods used
for screening;
(4) develop a model decision-matrix for newborn
screening expansion, including an evaluation of the
potential public health impact of such expansion, and
periodically update the recommended uniform screening
panel, as appropriate, based on such decision-matrix;
(5) consider ways to ensure that all States attain
the capacity to screen for the conditions described in
paragraph (3), and include in such consideration the
results of grant funding under section 1109; and
(6) provide such recommendations, advice or
information as may be necessary to enhance, expand or
improve the ability of the Secretary to reduce the
mortality or morbidity from heritable disorders, which
may include recommendations, advice, or information
dealing with--
(A) follow-up activities, including those
necessary to achieve rapid diagnosis in the
short-term, and those that ascertain long-term
case management outcomes and appropriate access
to related services;
(B) implementation, monitoring, and
evaluation of newborn screening activities,
including diagnosis, screening, follow-up, and
treatment activities;
(C) diagnostic and other technology used in
screening;
(D) the availability and reporting of
testing for conditions for which there is no
existing treatment;
(E) conditions not included in the
recommended uniform screening panel that are
treatable with Food and Drug Administration-
approved products or other safe and effective
treatments, as determined by scientific
evidence and peer review;
(F) minimum standards and related policies
and procedures used by State newborn screening
programs, such as language and terminology used
by State newborn screening programs to include
standardization of case definitions and names
of disorders for which newborn screening tests
are performed;
(G) quality assurance, oversight, and
evaluation of State newborn screening programs,
including ensuring that tests and technologies
used by each State meet established standards
for detecting and reporting positive screening
results;
(H) public and provider awareness and
education;
(I) the cost and effectiveness of newborn
screening and medical evaluation systems and
intervention programs conducted by State-based
programs;
(J) identification of the causes of, public
health impacts of, and risk factors for
heritable disorders; and
(K) coordination of surveillance
activities, including standardized data
collection and reporting, harmonization of
laboratory definitions for heritable disorders
and testing results, and confirmatory testing
and verification of positive results, in order
to assess and enhance monitoring of newborn
diseases.
(c) Membership.--
(1) In general.--The Secretary shall appoint not to
exceed 15 members to the Advisory Committee. In
appointing such members, the Secretary shall ensure
that the total membership of the Advisory Committee is
an odd number.
(2) Required members.--The Secretary shall appoint
to the Advisory Committee under paragraph (1)--
(A) the Administrator of the Health
Resources and Services Administration;
(B) the Director of the Centers for Disease
Control and Prevention;
(C) the Director of the National Institutes
of Health;
(D) the Director of the Agency for
Healthcare Research and Quality;
(E) the Commissioner of the Food and Drug
Administration;
(F) medical, technical, or scientific
professionals with special expertise in
heritable disorders, or in providing screening,
counseling, testing or specialty services for
newborns and children at risk for heritable
disorders;
(G) individuals with expertise in ethics
and infectious diseases who have worked and
published material in the area of newborn
screening;
(H) members of the public having special
expertise about or concern with heritable
disorders; and
(I) representatives from such Federal
agencies, public health constituencies, and
medical professional societies as determined to
be necessary by the Secretary, to fulfill the
duties of the Advisory Committee, as
established under subsection (b).
(d) Decision on Recommendations.--
(1) In general.--Not later than 180 days after the
Advisory Committee issues a recommendation pursuant to
this section, the Secretary shall adopt or reject such
recommendation.
(2) Pending recommendations.--The Secretary shall
adopt or reject any recommendation issued by the
Advisory Committee that is pending on the date of
enactment of the Newborn Screening Saves Lives Act of
2008 by not later than 180 days after the date of
enactment of such Act.
(3) Determinations to be made public.--The
Secretary shall publicize any determination on adopting
or rejecting a recommendation of the Advisory Committee
pursuant to this subsection, including the
justification for the determination.
(e) Annual Report.--Not later than 3 years after the date
of enactment of the Newborn Screening Saves Lives Act of 2008,
and each fiscal year thereafter, the Advisory Committee shall--
(1) publish a report on peer-reviewed newborn
screening guidelines, including follow-up and
treatment, in the United States;
(2) submit such report to the appropriate
committees of Congress, the Secretary, the Interagency
Coordinating Committee established under Section 1114,
and the State departments of health; and
(3) disseminate such report on as wide a basis as
practicable, including through posting on the internet
clearinghouse established under section 1112.
(f) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Advisory Committee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Newborn Screening Saves Lives Act of 2008.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $1,000,000 for
fiscal year 2009, $1,012,500 for fiscal year 2010, $1,025,000
for fiscal year 2011, $1,037,500 for fiscal year 2012, and
$1,050,000 for fiscal year 2013.
SEC. 1112. [300B-11] CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration (referred to in this part as the
``Administrator''), in consultation with the Director of the
Centers for Disease Control and Prevention and the Director of
the National Institutes of Health, shall establish and maintain
a central clearinghouse of current educational and family
support and services information, materials, resources,
research, and data on newborn screening to--
(1) enable parents and family members of newborns,
health professionals, industry representatives, and
other members of the public to increase their
awareness, knowledge, and understanding of newborn
screening;
(2) increase awareness, knowledge, and
understanding of newborn diseases and screening
services for expectant individuals and families; and
(3) maintain current data on quality indicators to
measure performance of newborn screening, such as
false-positive rates and other quality indicators as
determined by the Advisory Committee under section
1111.
(b) Internet Availability.--The Secretary, acting through
the Administrator, shall ensure that the clearinghouse
described under subsection (a)--
(1) is available on the Internet;
(2) includes an interactive forum;
(3) is updated on a regular basis, but not less
than quarterly; and
(4) provides--
(A) links to Government-sponsored, non-
profit, and other Internet websites of
laboratories that have demonstrated expertise
in newborn screening that supply research-based
information on newborn screening tests
currently available throughout the United
States;
(B) information about newborn conditions
and screening services available in each State
from laboratories certified under subpart 2 of
part F of title III, including information
about supplemental screening that is available
but not required, in the State where the infant
is born;
(C) current research on both treatable and
not-yet treatable conditions for which newborn
screening tests are available;
(D) the availability of Federal funding for
newborn and child screening for heritable
disorders including grants authorized under the
Newborn Screening Saves Lives Act of 2008; and
(E) other relevant information as
determined appropriate by the Secretary.
(c) Nonduplication.--In developing the clearinghouse under
this section, the Secretary shall ensure that such
clearinghouse minimizes duplication and supplements, not
supplants, existing information sharing efforts.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $2,500,000 for
fiscal year 2009, $2,531,250 for fiscal year 2010, $2,562,500
for fiscal year 2011, $2,593,750 for fiscal year 2012, and
$2,625,000 for fiscal year 2013.
SEC. 1113. [300B-12] LABORATORY QUALITY.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in
consultation with the Advisory Committee on Heritable Disorders
in Newborns and Children established under section 1111, shall
provide for--
(1) quality assurance for laboratories involved in
screening newborns and children for heritable
disorders, including quality assurance for newborn-
screening tests, performance evaluation services, and
technical assistance and technology transfer to newborn
screening laboratories to ensure analytic validity and
utility of screening tests; and
(2) appropriate quality control and other
performance test materials to evaluate the performance
of new screening tools.
(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2009, $5,062,500 for
fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500
for fiscal year 2012, and $5,250,000 for fiscal year 2013.
SEC. 1114. [300B-13] INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND
CHILD SCREENING.
(a) Purpose.--It is the purpose of this section to--
(1) assess existing activities and infrastructure,
including activities on birth defects and developmental
disabilities authorized under section 317C, in order to
make recommendations for programs to collect, analyze,
and make available data on the heritable disorders
recommended by the Advisory Committee on Heritable
Disorders in Newborns and Children under section 1111,
including data on the incidence and prevalence of, as
well as poor health outcomes resulting from, such
disorders; and
(2) make recommendations for the establishment of
regional centers for the conduct of applied
epidemiological research on effective interventions to
promote the prevention of poor health outcomes
resulting from such disorders as well as providing
information and education to the public on such
effective interventions.
(b) Establishment.--The Secretary shall establish an
Interagency Coordinating Committee on Newborn and Child
Screening (referred to in this section as the ``Interagency
Coordinating Committee'') to carry out the purpose of this
section.
(c) Composition.--The Interagency Coordinating Committee
shall be composed of the Director of the Centers for Disease
Control and Prevention, the Administrator, the Director of the
Agency for Healthcare Research and Quality, and the Director of
the National Institutes of Health, or their designees.
(d) Activities.--The Interagency Coordinating Committee
shall--
(1) report to the Secretary and the appropriate
committees of Congress on its recommendations related
to the purpose described in subsection (a); and
(2) carry out other activities determined
appropriate by the Secretary.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $1,000,000 for fiscal year 2009, $1,012,500 for
fiscal year 2010, $1,025,000 for fiscal year 2011, $1,037,500
for fiscal year 2012, and $1,050,000 for fiscal year 2013.
SEC. 1115. [300B-14] NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
(a) In General.--Not later than 180 days after the date of
enactment of this section, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in consultation with the Administrator and State departments of
health (or related agencies), shall develop a national
contingency plan for newborn screening for use by a State,
region, or consortia \1\ of States in the event of a public
health emergency.
---------------------------------------------------------------------------
\1\ The reference to ``consortia of States'' in subsection (a)
probably should refer to the ``consortium of States''.
---------------------------------------------------------------------------
(b) Contents.--The contingency plan developed under
subsection (a) shall include a plan for--
(1) the collection and transport of specimens;
(2) the shipment of specimens to State newborn
screening laboratories;
(3) the processing of specimens;
(4) the reporting of screening results to
physicians and families;
(5) the diagnostic confirmation of positive
screening results;
(6) ensuring the availability of treatment and
management resources;
(7) educating families about newborn screening; and
(8) carrying out other activities determined
appropriate by the Secretary.
SEC. 1116. [300B-15] HUNTER KELLY RESEARCH PROGRAM.
(a) Newborn Screening Activities.--
(1) In general.--The Secretary, in conjunction with
the Director of the National Institutes of Health and
taking into consideration the recommendations of the
Advisory Committee, may continue carrying out,
coordinating, and expanding research in newborn
screening (to be known as ``Hunter Kelly Newborn
Screening Research Program'') including--
(A) identifying, developing, and testing
the most promising new screening technologies,
in order to improve already existing screening
tests, increase the specificity of newborn
screening, and expand the number of conditions
for which screening tests are available;
(B) experimental treatments and disease
management strategies for additional newborn
conditions, and other genetic, metabolic,
hormonal, or functional conditions that can be
detected through newborn screening for which
treatment is not yet available; and
(C) other activities that would improve
newborn screening, as identified by the
Director.
(2) Additional newborn condition.--For purposes of
this subsection, the term ``additional newborn
condition'' means any condition that is not one of the
core conditions recommended by the Advisory Committee
and adopted by the Secretary.
(b) Funding.--In carrying out the research program under
this section, the Secretary and the Director shall ensure that
entities receiving funding through the program will provide
assurances, as practicable, that such entities will work in
consultation with the appropriate State departments of health,
and, as practicable, focus their research on screening
technology not currently performed in the States in which the
entities are located, and the conditions on the uniform
screening panel (or the standard test existing on the uniform
screening panel).
(c) Reports.--The Director is encouraged to include
information about the activities carried out under this section
in the biennial report required under section 403 of the
National Institutes of Health Reform Act of 2006. If such
information is included, the Director shall make such
information available to be included on the Internet
Clearinghouse established under section 1112.
(d) Nonduplication.--In carrying out programs under this
section, the Secretary shall minimize duplication and
supplement, not supplant, existing efforts of the type carried
out under this section.
(e) Peer Review.--Nothing in this section shall be
construed to interfere with the scientific peer-review process
at the National Institutes of Health.
Part B--Sudden Infant Death Syndrome
sudden infant death syndrome research and research reports
Sec. 1122. [300c-12] From the sums appropriated to the
Eunice Kennedy Shriver National Institute of Child Health and
Human Development, the Secretary shall assure that there are
applied to research of the type described in subparagraphs (A)
and (B) of subsection (b)(1) of this section such amounts each
year as will be adequate, given the leads and findings then
available from such research, in order to make maximum feasible
progress toward identification of infants at risk of sudden
infant death syndrome and prevention of sudden infant death
syndrome.
Part C--Hemophilia Programs
blood separation centers
Sec. 1132. [300c-22] (a) The Secretary may make grants to
and enter into contracts with public and nonprofit private
entities for projects to develop and expand, within existing
facilities, blood-separation centers to separate and make
available for distribution blood components to providers of
blood services and manufacturers of blood fractions. For
purposes of this section--
(1) the term ``blood components'' means those
constituents of whole blood which are used for therapy
and which are obtained by physical separation processes
which result in licensed products such as red blood
cells, platelets, white blood cells, AHF-rich plasma,
fresh-frozen plasma, cryoprecipitate, and single unit
plasma for infusion; and
(2) the term ``blood fractions'' means those
constituents of plasma which are used for therapy and
which are obtained by licensed fractionation processes
presently used in manufacturing which result in
licensed products such as normal serum albumin, plasma,
protein fraction, prothrombin complex, fibrinogen, AHF
concentrate, immune serum globulin, and hyperimmune
globulins.
(b) In the event the Secretary finds that there is an
insufficient supply of blood fractions available to meet the
needs for treatment of persons suffering from hemophilia, and
that public and other nonprofit private centers already engaged
in the production of blood fractions could alleviate such
insufficiency with assistance under this subsection, he may
make grants not to exceed $500,000 to such centers for the
purposes of alleviating the insufficiency.
(c) No grant or contract may be made under subsection (a)
or (b) unless an application therefor has been submitted to and
approved by the Secretary. Such an application shall be in such
form, submitted in such manner, and contain such information as
the Secretary shall by regulation prescribe.
(d) Contracts may be entered into under subsection (a)
without regard to section 3648 and 3709 of the Revised Statutes
(31 U.S.C. 529; 41 U.S.C. 5).
(e) For the purpose of making payments under grants and
contracts under subsections (a) and (b), there are authorized
to be appropriated $4,000,000 for fiscal year 1976, $5,000,000
for the fiscal year ending September 30, 1977, $3,450,000 for
the fiscal year ending September 30, 1978, $2,500,000 for the
fiscal year ending September 30, 1979, $3,000,000 for the
fiscal year ending September 30, 1980, $3,500,000 for the
fiscal year ending September 30, 1981.ATTORNEY: PMG/FD
(June 28, 1999) deg.
TITLE XII--TRAUMA CARE
Part A--General Authority and Duties of Secretary
SEC. 1201. [300D] ESTABLISHMENT.
(a) In General.--The Secretary shall, with respect to
trauma care--
(1) conduct and support research, training,
evaluations, and demonstration projects;
(2) foster the development of appropriate, modern
systems of such care through the sharing of information
among agencies and individuals involved in the study
and provision of such care;
(3) collect, compile, and disseminate information
on the achievements of, and problems experienced by,
State and local agencies and private entities in
providing trauma care and emergency medical services
and, in so doing, give special consideration to the
unique needs of rural areas;
(4) provide to State and local agencies technical
assistance to enhance each State's capability to
develop, implement, and sustain the trauma care
component of each State's plan for the provision of
emergency medical services;
(5) sponsor workshops and conferences; and
(6) promote the collection and categorization of
trauma data in a consistent and standardized manner.
(b) Grants, Cooperative Agreements, and Contracts.--The
Secretary may make grants, and enter into cooperative
agreements and contracts, for the purpose of carrying out
subsection (a).
SEC. 1202. [300D-3] ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE
IN RURAL AREAS.
(a) In General.--The Secretary may make grants to public
and nonprofit private entities for the purpose of carrying out
research and demonstration projects with respect to improving
the availability and quality of emergency medical services in
rural areas--
(1) by developing innovative uses of communications
technologies and the use of new communications
technology;
(2) by developing model curricula, such as advanced
trauma life support, for training emergency medical
services personnel, including first responders,
emergency medical technicians, emergency nurses and
physicians, and paramedics--
(A) in the assessment, stabilization,
treatment, preparation for transport, and
resuscitation of seriously injured patients,
with special attention to problems that arise
during long transports and to methods of
minimizing delays in transport to the
appropriate facility; and
(B) in the management of the operation of
the emergency medical services system;
(3) by making training for original certification,
and continuing education, in the provision and
management of emergency medical services more
accessible to emergency medical personnel in rural
areas through telecommunications, home studies,
providing teachers and training at locations accessible
to such personnel, and other methods;
(4) by developing innovative protocols and
agreements to increase access to prehospital care and
equipment necessary for the transportation of seriously
injured patients to the appropriate facilities;
(5) by evaluating the effectiveness of protocols
with respect to emergency medical services and systems;
and
(6) by increasing communication and coordination
with State trauma systems.
(b) Special Consideration for Certain Rural Areas.--In
making grants under subsection (a), the Secretary shall give
special consideration to any applicant for the grant that will
provide services under the grant in any rural area identified
by a State under section 1214(d)(1).
(c) Requirement of Application.--The Secretary may not make
a grant under subsection (a) unless an application for the
grant is submitted to the Secretary and the application is in
such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section.
SEC. 1203. [300D-5] COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE
IMPROVEMENT OF TRAUMA CARE.
(a) In General.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response, may make
grants to States, political subdivisions, or consortia of
States or political subdivisions for the purpose of improving
access to and enhancing the development of trauma care systems.
(b) Use of Funds.--The Secretary may make a grant under
this section only if the applicant agrees to use the grant--
(1) to integrate and broaden the reach of a trauma
care system, such as by developing innovative protocols
to increase access to prehospital care;
(2) to strengthen, develop, and improve an existing
trauma care system;
(3) to expand communications between the trauma
care system and emergency medical services through
improved equipment or a telemedicine system;
(4) to improve data collection and retention; or
(5) to increase education, training, and technical
assistance opportunities, such as training and
continuing education in the management of emergency
medical services accessible to emergency medical
personnel in rural areas through telehealth, home
studies, and other methods.
(c) Preference.--In selecting among States, political
subdivisions, and consortia of States or political subdivisions
for purposes of making grants under this section, the Secretary
shall give preference to applicants that--
(1) have developed a process, using national
standards, for designating trauma centers;
(2) recognize protocols for the delivery of
seriously injured patients to trauma centers;
(3) implement a process for evaluating the
performance of the trauma system; and
(4) agree to participate in information systems
described in section 1202 by collecting, providing, and
sharing information.
(d) Priority.--In making grants under this section, the
Secretary shall give priority to applicants that will use the
grants to focus on improving access to trauma care systems.
(e) Special Consideration.--In awarding grants under this
section, the Secretary shall give special consideration to
projects that demonstrate strong State or local support,
including availability of non-Federal contributions.
SEC. 1204. [300D-6] COMPETITIVE GRANTS FOR REGIONALIZED SYSTEMS FOR
EMERGENCY CARE RESPONSE.
(a) In General.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response, shall award
not fewer than 4 multiyear contracts or competitive grants to
eligible entities to support pilot projects that design,
implement, and evaluate innovative models of regionalized,
comprehensive, and accountable emergency care and trauma
systems.
(b) Eligible Entity; Region.--In this section:
(1) Eligible entity.--The term ``eligible entity''
means--
(A) a State or a partnership of 1 or more
States and 1 or more local governments; or
(B) an Indian tribe (as defined in section
4 of the Indian Health Care Improvement Act) or
a partnership of 1 or more Indian tribes.
(2) Region.--The term ``region'' means an area
within a State, an area that lies within multiple
States, or a similar area (such as a multicounty area),
as determined by the Secretary.
(3) Emergency services.--The term ``emergency
services'' includes acute, prehospital, and trauma
care.
(c) Pilot Projects.--The Secretary shall award a contract
or grant under subsection (a) to an eligible entity that
proposes a pilot project to design, implement, and evaluate an
emergency medical and trauma system that--
(1) coordinates with public health and safety
services, emergency medical services, medical
facilities, trauma centers, and other entities in a
region to develop an approach to emergency medical and
trauma system access throughout the region, including
9-1-1 Public Safety Answering Points and emergency
medical dispatch;
(2) includes a mechanism, such as a regional
medical direction or transport communications system,
that operates throughout the region to ensure that the
patient is taken to the medically appropriate facility
(whether an initial facility or a higher-level
facility) in a timely fashion;
(3) allows for the tracking of prehospital and
hospital resources, including inpatient bed capacity,
emergency department capacity, trauma center capacity,
on-call specialist coverage, ambulance diversion
status, and the coordination of such tracking with
regional communications and hospital destination
decisions; and
(4) includes a consistent region-wide prehospital,
hospital, and interfacility data management system
that--
(A) submits data to the National EMS
Information System, the National Trauma Data
Bank, and others;
(B) reports data to appropriate Federal and
State databanks and registries; and
(C) contains information sufficient to
evaluate key elements of prehospital care,
hospital destination decisions, including
initial hospital and interfacility decisions,
and relevant health outcomes of hospital care.
(d) Application.--
(1) In general.--An eligible entity that seeks a
contract or grant described in subsection (a) shall
submit to the Secretary an application at such time and
in such manner as the Secretary may require.
(2) Application information.--Each application
shall include--
(A) an assurance from the eligible entity
that the proposed system--
(i) has been coordinated with the
applicable State Office of Emergency
Medical Services (or equivalent State
office);
(ii) includes consistent indirect
and direct medical oversight of
prehospital, hospital, and
interfacility transport throughout the
region;
(iii) coordinates prehospital
treatment and triage, hospital
destination, and interfacility
transport throughout the region;
(iv) includes a categorization or
designation system for special medical
facilities throughout the region that
is integrated with transport and
destination protocols;
(v) includes a regional medical
direction, patient tracking, and
resource allocation system that
supports day-to-day emergency care and
surge capacity and is integrated with
other components of the national and
State emergency preparedness system;
and
(vi) addresses pediatric concerns
related to integration, planning,
preparedness, and coordination of
emergency medical services for infants,
children and adolescents; and
(B) such other information as the Secretary
may require.
(e) Requirement of Matching Funds.--
(1) In general.--The Secretary may not make a grant
under this section unless the State (or consortia of
States) involved agrees, with respect to the costs to
be incurred by the State (or consortia) in carrying out
the purpose for which such grant was made, to make
available non-Federal contributions (in cash or in kind
under paragraph (2)) toward such costs in an amount
equal to not less than $1 for each $3 of Federal funds
provided in the grant. Such contributions may be made
directly or through donations from public or private
entities.
(2) Non-federal contributions.--Non-Federal
contributions required in paragraph (1) may be in cash
or in kind, fairly evaluated, including equipment or
services (and excluding indirect or overhead costs).
Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent by the
Federal Government, may not be included in determining
the amount of such non-Federal contributions.
(f) Priority.--The Secretary shall give priority for the
award of the contracts or grants described in subsection (a) to
any eligible entity that serves a population in a medically
underserved area (as defined in section 330(b)(3)).
(g) Report.--Not later than 90 days after the completion of
a pilot project under subsection (a), the recipient of such
contract or grant described in shall submit to the Secretary a
report containing the results of an evaluation of the program,
including an identification of--
(1) the impact of the regional, accountable
emergency care and trauma system on patient health
outcomes for various critical care categories, such as
trauma, stroke, cardiac emergencies, neurological
emergencies, and pediatric emergencies;
(2) the system characteristics that contribute to
the effectiveness and efficiency of the program (or
lack thereof);
(3) methods of assuring the long-term financial
sustainability of the emergency care and trauma system;
(4) the State and local legislation necessary to
implement and to maintain the system;
(5) the barriers to developing regionalized,
accountable emergency care and trauma systems, as well
as the methods to overcome such barriers; and
(6) recommendations on the utilization of available
funding for future regionalization efforts.
(h) Dissemination of Findings.--The Secretary shall, as
appropriate, disseminate to the public and to the appropriate
Committees of the Congress, the information contained in a
report made under subsection (g).
Part B--Formula Grants With Respect to Modifications of State Plans
H4 deg.SEC. 1211. [300D-11] ESTABLISHMENT OF PROGRAM.
(a) Requirement of Allotments for States.--The Secretary
shall for each fiscal year make an allotment for each State in
an amount determined in accordance with section 1218. The
Secretary shall make payments, as grants, each fiscal year to
each State from the allotment for the State if the Secretary
approves for the fiscal year involved an application submitted
by the State pursuant to section 1217.
(b) Purpose.--Except as provided in section 1233, the
Secretary may not make payments under this part for a fiscal
year unless the State involved agrees that, with respect to the
trauma care component of the State plan for the provision of
emergency medical services, the payments will be expended only
for the purpose of developing, implementing, and monitoring the
modifications to such component described in section 1213.
SEC. 1212. [300D-12] REQUIREMENT OF MATCHING FUNDS FOR FISCAL YEARS
SUBSEQUENT TO FIRST FISCAL YEAR OF PAYMENTS.
(a) Non-Federal Contributions.--
(1) In general.--The Secretary may not make
payments under section 1211(a) unless the State
involved agrees, with respect to the costs described in
paragraph (2), to make available non-Federal
contributions (in cash or in kind under subsection
(b)(1)) toward such costs in an amount that--
(A) for the second and third fiscal years
of such payments to the State, is not less than
$1 for each $1 of Federal funds provided in
such payments for such fiscal years; and
(B) for the fourth and subsequent fiscal
years of such payments to the State, is not
less than $2 for each $1 of Federal funds
provided in such payments for such fiscal
years.
(2) Program costs.--The costs referred to in
paragraph (1) are--
(A) the costs to be incurred by the State
in carrying out the purpose described in
section 1211(b); or
(B) the costs of improving the quality and
availability of emergency medical services in
rural areas of the State.
(3) Initial year of payments.--The Secretary may
not require a State to make non-Federal contributions
as a condition of receiving payments under section
1211(a) for the first fiscal year of such payments to
the State.
(b) Determination of Amount of Non-Federal Contribution.--
With respect to compliance with subsection (a) as a condition
of receiving payments under section 1211(a)--
(1) a State may make the non-Federal contributions
required in such subsection in cash or in kind, fairly
evaluated, including plant, equipment, or services; and
(2) the Secretary may not, in making a
determination of the amount of non-Federal
contributions, include amounts provided by the Federal
Government or services assisted or subsidized to any
significant extent by the Federal Government.
SEC. 1213. [300D-13] REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE
OF ALLOTMENTS.
(a) Trauma Care Modifications to State Plan for Emergency
Medical Services.--With respect to the trauma care component of
a State plan for the provision of emergency medical services,
the modifications referred to in section 1211(b) are such
modifications to the State plan as may be necessary for the
State involved to ensure that the plan provides for access to
the highest possible quality of trauma care, and that the
plan--
(1) specifies that the modifications required
pursuant to paragraphs (2) through (11) will be
implemented by the principal State agency with respect
to emergency medical services or by the designee of
such agency;
(2) specifies a public or private entity that will
designate trauma care regions and trauma centers in the
State;
(3) subject to subsection (b), contains national
standards and requirements of the American College of
Surgeons or another appropriate entity for the
designation of level I and level II trauma centers, and
in the case of rural areas level III trauma centers
(including trauma centers with specified capabilities
and expertise in the care of pediatric trauma
patients), by such entity, including standards and
requirements for--
(A) the number and types of trauma patients
for whom such centers must provide care in
order to ensure that such centers will have
sufficient experience and expertise to be able
to provide quality care for victims of injury;
(B) the resources and equipment needed by
such centers; and
(C) the availability of rehabilitation
services for trauma patients;
(4) contains standards and requirements for the
implementation of regional trauma care systems,
including standards and guidelines (consistent with the
provisions of section 1867 of the Social Security Act)
for medically directed triage and transportation of
trauma patients (including patients injured in rural
areas) prior to care in designated trauma centers;
(5) subject to subsection (b), contains national
standards and requirements, including those of the
American Academy of Pediatrics and the American College
of Emergency Physicians, for medically directed triage
and transport of severely injured children to
designated trauma centers with specified capabilities
and expertise in the care of pediatric trauma patients;
(6) utilizes a program with procedures for the
evaluation of designated trauma centers (including
trauma centers described in paragraph (5)) and trauma
care systems;
(7) provides for the establishment and collection
of data in accordance with data collection requirements
developed in consultation with surgical, medical, and
nursing specialty groups, State and local emergency
medical services directors, and other trained
professionals in trauma care, from each designated
trauma center in the State of a central data reporting
and analysis system--
(A) to identify the number of severely
injured trauma patients and the number of
deaths from trauma within trauma care systems
in the State;
(B) to identify the cause of the injury and
any factors contributing to the injury;
(C) to identify the nature and severity of
the injury;
(D) to monitor trauma patient care
(including prehospital care) in each designated
trauma center within regional trauma care
systems in the State (including relevant
emergency-department discharges and
rehabilitation information) for the purpose of
evaluating the diagnosis, treatment, and
treatment outcome of such trauma patients;
(E) to identify the total amount of
uncompensated trauma care expenditures for each
fiscal year by each designated trauma center in
the State; and
(F) to identify patients transferred within
a regional trauma system, including reasons for
such transfer and the outcomes of such
patients;
(8) provides for the use of procedures by
paramedics and emergency medical technicians to assess
the severity of the injuries incurred by trauma
patients;
(9) provides for appropriate transportation and
transfer policies to ensure the delivery of patients to
designated trauma centers and other facilities within
and outside of the jurisdiction of such system,
including policies to ensure that only individuals
appropriately identified as trauma patients are
transferred to designated trauma centers, and to
provide periodic reviews of the transfers and the
auditing of such transfers that are determined to be
appropriate;
(10) conducts public education activities
concerning injury prevention and obtaining access to
trauma care;
(11) coordinates planning for trauma systems with
State disaster emergency planning and bioterrorism
hospital preparedness planning; and
(12) with respect to the requirements established
in this subsection, provides for coordination and
cooperation between the State and any other State with
which the State shares any standard metropolitan
statistical area.
(b) Certain Standards With Respect to Trauma Care Centers
and Systems.--
(1) In general.--The Secretary may not make
payments under section 1211(a) for a fiscal year unless
the State involved agrees that, in carrying out
paragraphs (3) through (5) of subsection (a), the State
will adopt standards for the designation of trauma
centers, and for triage, transfer, and transportation
policies, and that the State will, in adopting such
standards--
(A) take into account national standards
that outline resources for optimal care of
injured patients;
(B) consult with medical, surgical, and
nursing speciality groups, hospital
associations, emergency medical services State
and local directors, concerned advocates, and
other interested parties;
(C) conduct hearings on the proposed
standards after providing adequate notice to
the public concerning such hearing; and
(D) beginning in fiscal year 2008, take
into account the model plan described in
subsection (c).
(2) Quality of trauma care.--The highest quality of
trauma care shall be the primary goal of State
standards adopted under this subsection.
(3) Approval by the secretary.--The Secretary may
not make payments under section 1211(a) to a State if
the Secretary determines that--
(A) in the case of payments for fiscal year
2008 and subsequent fiscal years, the State has
not taken into account national standards,
including those of the American College of
Surgeons, the American College of Emergency
Physicians, and the American Academy of
Pediatrics, in adopting standards under this
subsection; or
(B) in the case of payments for fiscal year
2008 and subsequent fiscal years, the State has
not, in adopting such standards, taken into
account the model plan developed under
subsection (c).
(c) Model Trauma Care Plan.--
(1) In general.--Not later than 1 year after the
date of the enactment of the Trauma Care Systems
Planning and Development Act of 2007, the Secretary
shall update the model plan for the designation of
trauma centers and for triage, transfer, and
transportation policies that may be adopted for
guidance by the State. Such plan shall--
(A) take into account national standards,
including those of the American College of
Surgeons, American College of Emergency
Physicians, and the American Academy of
Pediatrics;
(B) take into account existing State plans;
(C) be developed in consultation with
medical, surgical, and nursing speciality
groups, hospital associations, emergency
medical services State directors and
associations, and other interested parties; and
(D) include standards for the designation
of rural health facilities and hospitals best
able to receive, stabilize, and transfer trauma
patients to the nearest appropriate designated
trauma center, and for triage, transfer, and
transportation policies as they relate to rural
areas.
(2) Applicability.--Standards described in
paragraph (1)(D) shall be applicable to all rural areas
in the State, including both non-metropolitan areas and
frontier areas that have populations of less than 6,000
per square mile.
(d) Rule of Construction With Respect to Number of
Designated Trauma Centers.--With respect to compliance with
subsection (a) as a condition of the receipt of a grant under
section 1211(a), such subsection may not be construed to
specify the number of trauma care centers designated pursuant
to such subsection.
SEC. 1214. [300D-14] REQUIREMENT OF SUBMISSION TO SECRETARY OF TRAUMA
PLAN AND CERTAIN INFORMATION.
(a) In General.--For each fiscal year, the Secretary may
not make payments to a State under section 1211(a) unless,
subject to subsection (b), the State submits to the Secretary
the trauma care component of the State plan for the provision
of emergency medical services, including any changes to the
trauma care component and any plans to address deficiencies in
the trauma care component.
(b) Interim Plan or Description of Efforts.--For each
fiscal year, if a State has not completed the trauma care
component of the State plan described in subsection (a), the
State may provide, in lieu of such completed component, an
interim component or a description of efforts made toward the
completion of the component.
(c) Information Received by State Reporting and Analysis
System.--The Secretary may not make payments to a State under
section 1211(a) unless the State agrees that the State will,
not less than once each year, provide to the Secretary the
information received by the State pursuant to section
1213(a)(7).
(d) Availability of Emergency Medical Services in Rural
Areas.--The Secretary may not make payments to a State under
section 1211(a) unless--
(1) the State identifies any rural area in the
State for which--
(A) there is no system of access to
emergency medical services through the
telephone number 911;
(B) there is no basic life-support system;
or
(C) there is no advanced life-support
system; and
(2) the State submits to the Secretary a list of
rural areas identified pursuant to paragraph (1) or, if
there are no such areas, a statement that there are no
such areas.
SEC. 1215. [300D-15] RESTRICTIONS ON USE OF PAYMENTS.
(a) In General.--The Secretary may not, except as provided
in subsection (b), make payments under section 1211(a) for a
fiscal year unless the State involved agrees that the payments
will not be expended--
(1) for any purpose other than developing,
implementing, and monitoring the modifications required
by section 1211(b) to be made to the State plan for the
provision of emergency medical services;
(2) to make cash payments to intended recipients of
services provided pursuant to this section;
(3) to purchase or improve real property (other
than minor remodeling of existing improvements to real
property);
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds; or
(5) to provide financial assistance to any entity
other than a public or nonprofit private entity.
(b) Waiver.--The Secretary may waive a restriction under
subsection (a) only if the Secretary determines that the
activities outlined by the State plan submitted under section
1214(a) by the State involved cannot otherwise be carried out.
SEC. 1217. [300D-17] REQUIREMENT OF SUBMISSION OF APPLICATION
CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
The Secretary may not make payments under section 1211(a)
to a State for a fiscal year unless--
(1) the State submits to the Secretary an
application for the payments containing agreements in
accordance with this part;
(2) the agreements are made through certification
from the chief executive officer of the State;
(3) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary;
(4) the application contains the plan provisions
and the information required to be submitted to the
Secretary pursuant to section 1214; and
(5) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this part.
SEC. 1218. [300D-18] DETERMINATION OF AMOUNT OF ALLOTMENT.
(a) Minimum Allotment.--Subject to the extent of amounts
made available in appropriations Acts, the amount of an
allotment under section 1211(a) for a State for a fiscal year
shall be the greater of--
(1) the amount determined under subsection (b)(1);
and
(2) $250,000 in the case of each of the several
States, the District of Columbia, and the Commonwealth
of Puerto Rico, and $50,000 in the case of each of the
Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands.
(b) Determination Under Formula.--
(1) In general.--The amount referred to in
subsection (a)(1) for a State for a fiscal year is the
sum of--
(A) an amount determined under paragraph
(2); and
(B) an amount determined under paragraph
(3).
(2) Amount relating to population.--The amount
referred to in subparagraph (A) of paragraph (1) for a
State for a fiscal year is the product of--
(A) an amount equal to 80 percent of the
amounts appropriated under section 1232(a) for
the fiscal year and available for allotment
under section 1211(a); and
(B) a percentage equal to the quotient of--
(i) an amount equal to the
population of the State; divided by
(ii) an amount equal to the
population of all States.
(3) Amount relating to square mileage.--The amount
referred to in subparagraph (B) of paragraph (1) for a
State for a fiscal year is the product of--
(A) an amount equal to 20 percent of the
amounts appropriated under section 1232(a) for
the fiscal year and available for allotment
under section 1211(a); and
(B) a percentage equal to the quotient of--
(i) an amount equal to the lesser
of 266,807 and the amount of the square
mileage of the State; divided by
(ii) an amount equal to the sum of
the respective amounts determined for
the States under clause (i).
(c) Disposition of Certain Funds Appropriated for
Allotments.--
(1) In general.--Amounts described in paragraph (2)
shall, in accordance with paragraph (3), be allotted by
the Secretary to States receiving payments under
section 1211(a) for the fiscal year (other than any
State referred to in paragraph (2)(C)).
(2) Type of amounts.--The amounts referred to in
paragraph (1) are any amounts made available pursuant
to 1232(b)(3) that are not paid under section 1211(a)
to a State as a result of--
(A) the failure of the State to submit an
application under section 1217;
(B) the failure, in the determination of
the Secretary, of the State to prepare within a
reasonable period of time such application in
compliance with such section; or
(C) the State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made for the State.
(3) Amount.--The amount of an allotment under
paragraph (1) for a State for a fiscal year shall be an
amount equal to the product of--
(A) an amount equal to the amount described
in paragraph (2) for the fiscal year involved;
and
(B) the percentage determined under
subsection (b)(2) for the State.
SEC. 1219. [300D-19] FAILURE TO COMPLY WITH AGREEMENTS.
(a) Repayment of Payments.--
(1) Requirement.--The Secretary may, in accordance
with subsection (b), require a State to repay any
payments received by the State pursuant to section
1211(a) that the Secretary determines were not expended
by the State in accordance with the agreements required
to be made by the State as a condition of the receipt
of payments under such section.
(2) Offset of amounts.--If a State fails to make a
repayment required in paragraph (1), the Secretary may
offset the amount of the repayment against any amount
due to be paid to the State under section 1211(a).
(b) Opportunity for a Hearing.--Before requiring repayment
of payments under subsection (a)(1), the Secretary shall
provide to the State an opportunity for a hearing.
H4 deg.SEC. 1220. [300D-20] PROHIBITION AGAINST CERTAIN
FALSE STATEMENTS.
(a) In General.--
(1) False statements or representations.--A person
may not knowingly and willfully make or cause to be
made any false statement or representation of a
material fact in connection with the furnishing of
items or services for which payments may be made by a
State from amounts paid to the State under section
1211(a).
(2) Concealing or failing to disclose
information.--A person with knowledge of the occurrence
of any event affecting the right of the person to
receive any payments from amounts paid to the State
under section 1211(a) may not conceal or fail to
disclose any such event with the intent of fraudulently
securing such amount.
(b) Criminal Penalty for Violation of Prohibition.--Any
person who violates a prohibition established in subsection (a)
may for each violation be fined in accordance with title 18,
United States Code, or imprisoned for not more than 5 years, or
both.
H4 deg.SEC. 1221. [300D-21] TECHNICAL ASSISTANCE AND
PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
LIEU OF GRANT FUNDS.
(a) Technical Assistance.--The Secretary shall, without
charge to a State receiving payments under section 1211(a),
provide to the State (or to any public or nonprofit private
entity designated by the State) technical assistance with
respect to the planning, development, and operation of any
program carried out pursuant to section 1211(b). The Secretary
may provide such technical assistance directly, through
contract, or through grants.
(b) Provision by Secretary of Supplies and Services in Lieu
of Grant Funds.--
(1) In general.--Upon the request of a State
receiving payments under section 1211(a), the Secretary
may, subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding the
State in carrying out section 1211(b) and, for such
purpose, may detail to the State any officer or
employee of the Department of Health and Human
Services.
(2) Reduction in payments.--With respect to a
request described in paragraph (1), the Secretary shall
reduce the amount of payments to the State under
section 1211(a) by an amount equal to the costs of
detailing personnel and the fair market value of any
supplies, equipment, or services provided by the
Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request,
expend the amounts withheld.
H4 deg.SEC. 1222. [300D-22] REPORT BY SECRETARY.
Not later than October 1, 2008, the Secretary shall report
to the appropriate committees of Congress on the activities of
the States carried out pursuant to section 1211. Such report
shall include an assessment of the extent to which Federal and
State efforts to develop systems of trauma care and to
designate trauma centers have reduced the incidence of
mortality, and the incidence of permanent disability, resulting
from trauma. Such report may include any recommendations of the
Secretary for appropriate administrative and legislative
initiatives with respect to trauma care.
Part C--General Provisions Regarding Parts A and B
SEC. 1231. [300D-31] DEFINITIONS.
For purposes of this part and parts A and B:
(1) Designated trauma center.--The term
``designated trauma center'' means a trauma center
designated in accordance with the modifications to the
State plan described in section 1213.
(2) State plan regarding emergency medical
services.--The term ``State plan'', with respect to the
provision of emergency medical services, means a plan
for a comprehensive, organized system to provide for
the access, response, triage, field stabilization,
transport, hospital stabilization, definitive care, and
rehabilitation of patients of all ages with respect to
emergency medical services.
(3) State.--The term ``State'' means each of the
several States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam,
American Samoa, and the Commonwealth of the Northern
Mariana Islands.
(4) Trauma.--The term ``trauma'' means an injury
resulting from exposure to a mechanical force.
(5) Trauma care component of state plan.--The term
``trauma care component'', with respect to components
of the State plan for the provision of emergency
medical services, means a plan for a comprehensive
health care system, within rural and urban areas of the
State, for the prompt recognition, prehospital care,
emergency medical care, acute surgical and medical
care, rehabilitation, and outcome evaluation of
seriously injured patients.
SEC. 1232. [300D-32] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out parts A and B, subject to subsections (b) and (c),
there are authorized to be appropriated $24,000,000 for each of
fiscal years 2010 through 2014.
(b) Reservation of Funds.--If the amount appropriated under
subsection (a) for a fiscal year is equal to or less than
$1,000,000, such appropriation is available only for the
purpose of carrying out part A. If the amount so appropriated
is greater than $1,000,000, 50 percent of such appropriation
shall be made available for the purpose of carrying out part A
and 50 percent shall be made available for the purpose of
carrying out part B.
(c) Allocation of Part A Funds.--Of the amounts
appropriated under subsection (a) for a fiscal year to carry
out part A--
(1) 10 percent of such amounts for such year shall
be allocated for administrative purposes; and
(2) 10 percent of such amounts for such year shall
be allocated for the purpose of carrying out section
1202.
(d) Authority.--For the purpose of carrying out parts A
through C, beginning on the date of enactment of the Patient
Protection and Affordable Care Act, the Secretary shall
transfer authority in administering grants and related
authorities under such parts from the Administrator of the
Health Resources and Services Administration to the Assistant
Secretary for Preparedness and Response.
Part D--Trauma Centers Operating in Areas Severely Affected by Drug-
Related Violence
H4 deg.SEC. 1241. [300D-41] GRANTS FOR CERTAIN TRAUMA
CENTERS.
(a) In General.--The Secretary shall establish 3 programs
to award grants to qualified public, nonprofit Indian Health
Service, Indian tribal, and urban Indian trauma centers--
(1) to assist in defraying substantial
uncompensated care costs;
(2) to further the core missions of such trauma
centers, including by addressing costs associated with
patient stabilization and transfer, trauma education
and outreach, coordination with local and regional
trauma systems, essential personnel and other fixed
costs, and expenses associated with employee and non-
employee physician services; and
(3) to provide emergency relief to ensure the
continued and future availability of trauma services.
(b) Minimum Qualifications of Trauma Centers.--
(1) Participation in trauma care system operating
under certain professional guidelines.--Except as
provided in paragraph (2), the Secretary may not award
a grant to a trauma center under subsection (a) unless
the trauma center is a participant in a trauma system
that substantially complies with section 1213.
(2) Exemption.--Paragraph (1) shall not apply to
trauma centers that are located in States with no
existing trauma care system.
(3) Qualification for substantial uncompensated
care costs.--The Secretary shall award substantial
uncompensated care grants under subsection (a)(1) only
to trauma centers meeting at least 1 of the criteria in
1 of the following 3 categories:
(A) Category a.--The criteria for category
A are as follows:
(i) At least 40 percent of the
visits in the emergency department of
the hospital in which the trauma center
is located were charity or self-pay
patients.
(ii) At least 50 percent of the
visits in such emergency department
were Medicaid (under title XIX of the
Social Security Act (42 U.S.C. 1396 et
seq.)) and charity and self-pay
patients combined.
(B) Category b.--The criteria for category
B are as follows:
(i) At least 35 percent of the
visits in the emergency department were
charity or self-pay patients.
(ii) At least 50 percent of the
visits in the emergency department were
Medicaid and charity and self-pay
patients combined.
(C) Category c.--The criteria for category
C are as follows:
(i) At least 20 percent of the
visits in the emergency department were
charity or self-pay patients.
(ii) At least 30 percent of the
visits in the emergency department were
Medicaid and charity and self-pay
patients combined.
(4) Trauma centers in 1115 waiver states.--
Notwithstanding paragraph (3), the Secretary may award
a substantial uncompensated care grant to a trauma
center under subsection (a)(1) if the trauma center
qualifies for funds under a Low Income Pool or Safety
Net Care Pool established through a waiver approved
under section 1115 of the Social Security Act (42
U.S.C. 1315).
(5) Designation.--The Secretary may not award a
grant to a trauma center unless such trauma center is
verified by the American College of Surgeons or
designated by an equivalent State or local agency.
(c) Additional Requirements.--The Secretary may not award a
grant to a trauma center under subsection (a)(1) unless such
trauma center--
(1) submits to the Secretary a plan satisfactory to
the Secretary that demonstrates a continued commitment
to serving trauma patients regardless of their ability
to pay; and
(2) has policies in place to assist patients who
cannot pay for part or all of the care they receive,
including a sliding fee scale, and to ensure fair
billing and collection practices.
H4 deg.SEC. 1242. [300D-42] PREFERENCES IN MAKING GRANTS.
(a) Substantial Uncompensated Care Awards.--
(1) In general.--The Secretary shall establish an
award basis for each eligible trauma center for grants
under section 1241(a)(1) according to the percentage
described in paragraph (2), subject to the requirements
of section 1241(b)(3).
(2) Percentages.--The applicable percentages are as
follows:
(A) With respect to a category A trauma
center, 100 percent of the uncompensated care
costs.
(B) With respect to a category B trauma
center, not more than 75 percent of the
uncompensated care costs.
(C) With respect to a category C trauma
center, not more than 50 percent of the
uncompensated care costs.
(b) \1\ Core Mission Awards.--
---------------------------------------------------------------------------
\1\ So in law. Subsection (b) includes a paragraph (1) but does not
include subsequent paragaraphs.
---------------------------------------------------------------------------
(1) In general.--In awarding grants under section
1241(a)(2), the Secretary shall--
(A) reserve 25 percent of the amount
allocated for core mission awards for Level III
and Level IV trauma centers; and
(B) reserve 25 percent of the amount
allocated for core mission awards for large
urban Level I and II trauma centers--
(i) that have at least 1 graduate
medical education fellowship in trauma
or trauma related specialties for which
demand is exceeding supply;
(ii) for which--
(I) annual uncompensated
care costs exceed $10,000,000;
or
(II) at least 20 percent of
emergency department visits are
charity or self-pay or Medicaid
patients; and
(iii) that are not eligible for
substantial uncompensated care awards
under section 1241(a)(1).
(c) Emergency Awards.--In awarding grants under section
1241(a)(3), the Secretary shall--
(1) give preference to any application submitted by
a trauma center that provides trauma care in a
geographic area in which the availability of trauma
care has significantly decreased or will significantly
decrease if the center is forced to close or downgrade
service or growth in demand for trauma services exceeds
capacity; and
(2) reallocate any emergency awards funds not
obligated due to insufficient, or a lack of qualified,
applications to the significant uncompensated care
award program.
H4 deg.SEC. 1243. [300D-43] CERTAIN AGREEMENTS.
(a) Maintenance of Financial Support.--The Secretary may
require a trauma center receiving a grant under section 1241(a)
to maintain access to trauma services at comparable levels to
the prior year during the grant period.
(b) Trauma Care Registry.--The Secretary may require the
trauma center receiving a grant under section 1241(a) to
provide data to a national and centralized registry of trauma
cases, in accordance with guidelines developed by the American
College of Surgeons, and as the Secretary may otherwise
require.
H4 deg.SEC. 1244. [300D-44] GENERAL PROVISIONS.
(a) Application.--The Secretary may not award a grant to a
trauma center under section 1241(a) unless such center submits
an application for the grant to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out this part.
(b) Limitation on Duration of Support.--The period during
which a trauma center receives payments under a grant under
section 1241(a)(3) shall be for 3 fiscal years, except that the
Secretary may waive such requirement for a center and authorize
such center to receive such payments for 1 additional fiscal
year.
(c) Limitation on Amount of Grant.--Notwithstanding section
1242(a), a grant under section 1241 may not be made in an
amount exceeding $2,000,000 for each fiscal year.
(d) Eligibility.--Except as provided in section
1242(b)(1)(B)(iii), acquisition of, or eligibility for, a grant
under section 1241(a) shall not preclude a trauma center from
being eligible for other grants described in such section.
(e) Funding Distribution.--Of the total amount appropriated
for a fiscal year under section 1245, 70 percent shall be used
for substantial uncompensated care awards under section
1241(a)(1), 20 percent shall be used for core mission awards
under section 1241(a)(2), and 10 percent shall be used for
emergency awards under section 1241(a)(3).
(f) Minimum Allowance.--Notwithstanding subsection (e), if
the amount appropriated for a fiscal year under section 1245 is
less than $25,000,000, all available funding for such fiscal
year shall be used for substantial uncompensated care awards
under section 1241(a)(1).
(g) Substantial Uncompensated Care Award Distribution and
Proportional Share.--Notwithstanding section 1242(a), of the
amount appropriated for substantial uncompensated care grants
for a fiscal year, the Secretary shall--
(1) make available--
(A) 50 percent of such funds for category A
trauma center grantees;
(B) 35 percent of such funds for category B
trauma center grantees; and
(C) 15 percent of such funds for category C
trauma center grantees; and
(2) provide available funds within each category in
a manner proportional to the award basis specified in
section 1242(a)(2) to each eligible trauma center.
(h) Report.--Beginning 2 years after the date of enactment
of the Patient Protection and Affordable Care Act, and every 2
years thereafter, the Secretary shall biennially report to
Congress regarding the status of the grants made under section
1241 and on the overall financial stability of trauma centers.
SEC. 1245. [300D-45] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated $100,000,000 for fiscal year
2009, and such sums as may be necessary for each of fiscal
years 2010 through 2015. Such authorization of appropriations
is in addition to any other authorization of appropriations or
amounts that are available for such purpose.
SEC. 1246. [300D-46] DEFINITION.
In this part, the term ``uncompensated care costs'' means
unreimbursed costs from serving self-pay, charity, or Medicaid
patients, without regard to payment under section 1923 of the
Social Security Act, all of which are attributable to emergency
care and trauma care, including costs related to subsequent
inpatient admissions to the hospital.
Part E--Miscellaneous Programs \1\
SEC. 1251. [300D-51] RESIDENCY TRAINING PROGRAMS IN EMERGENCY MEDICINE.
(a) In General.--The Secretary may make grants to public
and nonprofit private entities for the purpose of planning and
developing approved residency training programs in emergency
medicine.
(b) Identification and Referral of Domestic Violence.--The
Secretary may make a grant under subsection (a) only if the
applicant involved agrees that the training programs under
subsection (a) will provide education and training in
identifying and referring cases of domestic violence.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there is authorized to be
appropriated $400,000 for each of the fiscal years 2008 though
2012.
SEC. 1252. [300D-52] STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC
BRAIN INJURY.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make grants to States and American Indian
consortia for the purpose of carrying out projects to improve
access to rehabilitation and other services regarding traumatic
brain injury.
(b) State Advisory Board.--
(1) In general.--The Secretary may make a grant
under subsection (a) only if the State or American
Indian consortium involved agrees to establish an
advisory board within the appropriate health department
of the State or American Indian consortium or within
another department as designated by the chief executive
officer of the State or American Indian consortium.
(2) Functions.--An advisory board established under
paragraph (1) shall advise and make recommendations to
the State or American Indian consortium on ways to
improve services coordination regarding traumatic brain
injury. Such advisory boards shall encourage citizen
participation through the establishment of public
hearings and other types of community outreach
programs. In developing recommendations under this
paragraph, such boards shall consult with Federal,
State, and local governmental agencies and with
citizens groups and other private entities.
(3) Composition.--An advisory board established
under paragraph (1) shall be composed of--
(A) representatives of--
(i) the corresponding State or
American Indian consortium agencies
involved;
(ii) public and nonprofit private
health related organizations;
(iii) other disability advisory or
planning groups within the State or
American Indian consortium;
(iv) members of an organization or
foundation representing individuals
with traumatic brain injury in that
State or American Indian consortium;
and
(v) injury control programs at the
State or local level if such programs
exist; and
(B) a substantial number of individuals
with traumatic brain injury, or the family
members of such individuals.
(c) Matching Funds.--
(1) In general.--With respect to the costs to be
incurred by a State or American Indian consortium in
carrying out the purpose described in subsection (a),
the Secretary may make a grant under such subsection
only if the State or American Indian consortium agrees
to make available non-Federal contributions toward such
costs in an amount that is not less than $1 for each $2
of Federal funds provided under the grant.
(2) Determination of amount contributed.--Non-
Federal contributions under paragraph (1) may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such
contributions.
(d) Application for Grant.--The Secretary may make a grant
under subsection (a) only if an application for the grant is
submitted to the Secretary and the application is in such form,
is made in such manner, and contains such agreements,
assurances, and information as the Secretary determines to be
necessary to carry out this section.
(e) Continuation of Previously Awarded Demonstration
Projects.--A State or American Indian consortium that received
a grant under this section prior to the date of the enactment
of the Traumatic Brain Injury Act of 2008 may complete the
activities funded by the grant.
(f) Use of State and American Indian Consortium Grants.--
(1) Community services and supports.--A State or
American Indian consortium shall (directly or through
awards of contracts to nonprofit private entities) use
amounts received under a grant under this section for
the following:
(A) To develop, change, or enhance
community-based service delivery systems that
include timely access to comprehensive
appropriate services and supports. Such service
and supports--
(i) shall promote full
participation by individuals with brain
injury and their families in decision
making regarding the services and
supports; and
(ii) shall be designed for
children, youth, and adults with
traumatic brain injury.
(B) To focus on outreach to underserved and
inappropriately served individuals, such as
individuals in institutional settings,
individuals with low socioeconomic resources,
individuals in rural communities, and
individuals in culturally and linguistically
diverse communities.
(C) To award contracts to nonprofit
entities for consumer or family service access
training, consumer support, peer mentoring, and
parent to parent programs.
(D) To develop individual and family
service coordination or case management
systems.
(E) To support other needs identified by
the advisory board under subsection (b) for the
State or American Indian consortium involved.
(2) Best practices.--
(A) In general.--State or American Indian
consortium services and supports provided under
a grant under this section shall reflect the
best practices in the field of traumatic brain
injury, shall be in compliance with title II of
the Americans with Disabilities Act of 1990,
and shall be supported by quality assurance
measures as well as state-of-the-art health
care and integrated community supports,
regardless of the severity of injury.
(B) Demonstration by state agency.--The
State or American Indian consortium agency
responsible for administering amounts received
under a grant under this section shall
demonstrate that it has obtained knowledge and
expertise of traumatic brain injury and the
unique needs associated with traumatic brain
injury.
(3) State capacity building.--A State or American
Indian consortium may use amounts received under a
grant under this section to--
(A) educate consumers and families;
(B) train professionals in public and
private sector financing (such as third party
payers, State agencies, community-based
providers, schools, and educators);
(C) develop or improve case management or
service coordination systems;
(D) develop best practices in areas such as
family or consumer support, return to work,
housing or supportive living personal
assistance services, assistive technology and
devices, behavioral health services, substance
abuse services, and traumatic brain injury
treatment and rehabilitation;
(E) tailor existing State or American
Indian consortium systems to provide
accommodations to the needs of individuals with
brain injury (including systems administered by
the State or American Indian consortium
departments responsible for health, mental
health, labor/employment, education, mental
retardation /developmental disorders,
transportation, and correctional systems);
(F) improve data sets coordinated across
systems and other needs identified by a State
or American Indian consortium plan supported by
its advisory council; and
(G) develop capacity within targeted
communities.
(g) Coordination of Activities.--The Secretary shall ensure
that activities under this section are coordinated as
appropriate with other Federal agencies that carry out
activities regarding traumatic brain injury.
(h) Report.--Not less than biennially, the Secretary shall
submit to the Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Health, Education,
Labor, and Pensions of the Senate, a report describing the
findings and results of the programs established under this
section, \1\ and section 1253 including measures of outcomes
and consumer and surrogate satisfaction.
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\1\ The comma after ``this section'' probably should be moved to
follow the reference to ``section 1253''.
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(i) Definitions.--For purposes of this section:
(1) The terms ``American Indian consortium'' and
``State'' have the meanings given to those terms in
section 1253.
(2) The term ``traumatic brain injury'' means an
acquired injury to the brain. Such term does not
include brain dysfunction caused by congenital or
degenerative disorders, nor birth trauma, but may
include brain injuries caused by anoxia due to trauma.
The Secretary may revise the definition of such term as
the Secretary determines necessary, after consultation
with States and other appropriate public or nonprofit
private entities.
(j) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005, and such sums as may be
necessary for each of the fiscal years 2009 through 2012.
SEC. 1253. [300D-53] STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration (referred to in this section as the
``Administrator''), shall make grants to protection and
advocacy systems for the purpose of enabling such systems to
provide services to individuals with traumatic brain injury.
(b) Services Provided.--Services provided under this
section may include the provision of--
(1) information, referrals, and advice;
(2) individual and family advocacy;
(3) legal representation; and
(4) specific assistance in self-advocacy.
(c) Application.--To be eligible to receive a grant under
this section, a protection and advocacy system shall submit an
application to the Administrator at such time, in such form and
manner, and accompanied by such information and assurances as
the Administrator may require.
(d) Appropriations Less Than $2,700,000.--
(1) In general.--With respect to any fiscal year in
which the amount appropriated under subsection (l) to
carry out this section is less than $2,700,000, the
Administrator shall make grants from such amount to
individual protection and advocacy systems within
States to enable such systems to plan for, develop
outreach strategies for, and carry out services
authorized under this section for individuals with
traumatic brain injury.
(2) Amount.--The amount of each grant provided
under paragraph (1) shall be determined as set forth in
paragraphs (2) and (3) of subsection (e).
(e) Appropriations of $2,700,000 or More.--
(1) Population basis.--Except as provided in
paragraph (2), with respect to each fiscal year in
which the amount appropriated under subsection (l) to
carry out this section is $2,700,000 or more, the
Administrator shall make a grant to a protection and
advocacy system within each State.
(2) Amount.--The amount of a grant provided to a
system under paragraph (1) shall be equal to an amount
bearing the same ratio to the total amount appropriated
for the fiscal year involved under subsection (l) as
the population of the State in which the grantee is
located bears to the population of all States.
(3) Minimums.--Subject to the availability of
appropriations, the amount of a grant a protection and
advocacy system under paragraph (1) for a fiscal year
shall--
(A) in the case of a protection and
advocacy system located in American Samoa,
Guam, the United States Virgin Islands, or the
Commonwealth of the Northern Mariana Islands,
and the protection and advocacy system serving
the American Indian consortium, not be less
than $20,000; and
(B) in the case of a protection and
advocacy system in a State not described in
subparagraph (A), not be less than $50,000.
(4) Inflation adjustment.--For each fiscal year in
which the total amount appropriated under subsection
(l) to carry out this section is $5,000,000 or more,
and such appropriated amount exceeds the total amount
appropriated to carry out this section in the preceding
fiscal year, the Administrator shall increase each of
the minimum grants amount described in subparagraphs
(A) and (B) of paragraph (3) by a percentage equal to
the percentage increase in the total amount
appropriated under subsection (l) to carry out this
section between the preceding fiscal year and the
fiscal year involved.
(f) Carryover.--Any amount paid to a protection and
advocacy system that serves a State or the American Indian
consortium for a fiscal year under this section that remains
unobligated at the end of such fiscal year shall remain
available to such system for obligation during the next fiscal
year for the purposes for which such amount was originally
provided.
(g) Direct Payment.--Notwithstanding any other provision of
law, each fiscal year not later than October 1, the
Administrator shall pay directly to any protection and advocacy
system that complies with the provisions of this section, the
total amount of the grant for such system, unless the system
provides otherwise for such payment.
(h) Annual Report.--Each protection and advocacy system
that receives a payment under this section shall submit an
annual report to the Administrator concerning the services
provided to individuals with traumatic brain injury by such
system.
(i) Data Collection.--The Administrator of the Health
Resources and Services Administration and the Commissioner of
the Administration on Developmental Disabilities shall enter
into an agreement to coordinate the collection of data by the
Administrator and the Commissioner regarding protection and
advocacy services.
(j) Training and Technical Assistance.--
(1) Grants.--For any fiscal year for which the
amount appropriated to carry out this section is
$6,000,000 or greater, the Administrator shall use 2
percent of such amount to make a grant to an eligible
national association for providing for training and
technical assistance to protection and advocacy
systems.
(2) Definition.--In this subsection, the term
``eligible national association'' means a national
association with demonstrated experience in providing
training and technical assistance to protection and
advocacy systems.
(k) System Authority.--In providing services under this
section, a protection and advocacy system shall have the same
authorities, including access to records, as such system would
have for purposes of providing services under subtitle C of the
Developmental Disabilities Assistance and Bill of Rights Act of
2000 \1\.
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\1\ The reference to subtitle C of the Developmental Disabilities
Assistance and Bill of Rights Act of 2000 should refer to subtitle C of
``title I'' of such Act.
---------------------------------------------------------------------------
(l) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $5,000,000 for
fiscal year 2001, and such sums as may be necessary for each
the fiscal years 2009 through 2012.
(m) Definitions.--In this section:
(1) American indian consortium.--The term
``American Indian consortium'' means a consortium
established under part C of the Developmental
Disabilities Assistance Bill of Rights Act (42 U.S.C.
6042 et seq.).
(2) Protection and advocacy system.--The term
``protection and advocacy system'' means a protection
and advocacy system established under part C of the
Developmental Disabilities Assistance and Bill of
Rights Act (42 U.S.C. 6042 et seq.).
(3) State.--The term ``State'', unless otherwise
specified, means the several States of the United
States, the District of Columbia, the Commonwealth of
Puerto Rico, the United States Virgin Islands, Guam,
American Samoa, and the Commonwealth of the Northern
Mariana Islands.
Part F--Interagency Program for Trauma Research
SEC. 1261. [300D-61] ESTABLISHMENT OF PROGRAM.
(a) In General.--The Secretary, acting through the Director
of the National Institutes of Health (in this section referred
to as the ``Director''), shall establish a comprehensive
program of conducting basic and clinical research on trauma (in
this section referred to as the ``Program''). The Program shall
include research regarding the diagnosis, treatment,
rehabilitation, and general management of trauma.
(b) Plan for Program.--
(1) In general.--The Director, in consultation with
the Trauma Research Interagency Coordinating Committee
established under subsection (g), shall establish and
implement a plan for carrying out the activities of the
Program, including the activities described in
subsection (d). All such activities shall be carried
out in accordance with the plan. The plan shall be
periodically reviewed, and revised as appropriate.
(2) Submission to congress.--Not later than
December 1, 1993, the Director shall submit the plan
required in paragraph (1) to the Committee on Energy
and Commerce of the House of Representatives, and to
the Committee on Health, Education, Labor, and Pensions
of the Senate, together with an estimate of the funds
needed for each of the fiscal years 1994 through 1996
to implement the plan.
(c) Participating Agencies; Coordination and
Collaboration.--The Director--
(1) shall provide for the conduct of activities
under the Program by the Directors of the agencies of
the National Institutes of Health involved in research
with respect to trauma;
(2) shall ensure that the activities of the Program
are coordinated among such agencies; and
(3) shall, as appropriate, provide for
collaboration among such agencies in carrying out such
activities.
(d) Certain Activities of Program.--The Program shall
include--
(1) studies with respect to all phases of trauma
care, including prehospital, resuscitation, surgical
intervention, critical care, infection control, wound
healing, nutritional care and support, and medical
rehabilitation care;
(2) basic and clinical research regarding the
response of the body to trauma and the acute treatment
and medical rehabilitation of individuals who are the
victims of trauma;
(3) basic and clinical research regarding trauma
care for pediatric and geriatric patients; and
(4) the authority to make awards of grants or
contracts to public or nonprofit private entities for
the conduct of basic and applied research regarding
traumatic brain injury, which research may include--
(A) the development of new methods and
modalities for the more effective diagnosis,
measurement of degree of brain injury, post-
injury monitoring and prognostic assessment of
head injury for acute, subacute and later
phases of care;
(B) the development, modification and
evaluation of therapies that retard, prevent or
reverse brain damage after acute head injury
\1\, that arrest further deterioration
following injury and that provide the
restitution of function for individuals with
long-term injuries;
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\1\ Section 1303(a)(2) of Public Law 106-310 (114 Stat. 1138)
provides that subparagraph (B) is amended by striking ``acute injury''
and inserting ``acute brain injury''. The amendment cannot be executed
because the term to be struck does not appear in subparagraph (B).
(Compare ``acute injury'' and ``acute head injury''.)
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(C) the development of research on a
continuum of care from acute care through
rehabilitation, designed, to the extent
practicable, to integrate rehabilitation and
long-term outcome evaluation with acute care
research;
(D) the development of programs that
increase the participation of academic centers
of excellence in brain injury treatment and
rehabilitation research and training; and
(E) carrying out subparagraphs (A) through
(D) with respect to cognitive disorders and
neurobehavioral consequences arising from
traumatic brain injury, including the
development, modification, and evaluation of
therapies and programs of rehabilitation toward
reaching or restoring normal capabilities in
areas such as reading, comprehension, speech,
reasoning, and deduction.
(e) Mechanisms of Support.--In carrying out the Program,
the Director, acting through the Directors of the agencies
referred to in subsection (c)(1), may make grants to public and
nonprofit entities, including designated trauma centers.
(f) Resources.--The Director shall assure the availability
of appropriate resources to carry out the Program, including
the plan established under subsection (b) (including the
activities described in subsection (d)).
(g) Coordinating Committee.--
(1) In general.--There shall be established a
Trauma Research Interagency Coordinating Committee (in
this section referred to as the ``Coordinating
Committee'').
(2) Duties.--The Coordinating Committee shall make
recommendations regarding--
(A) the activities of the Program to be
carried out by each of the agencies represented
on the Committee and the amount of funds needed
by each of the agencies for such activities;
and
(B) effective collaboration among the
agencies in carrying out the activities.
(3) Composition.--The Coordinating Committee shall
be composed of the Directors of each of the agencies
that, under subsection (c), have responsibilities under
the Program, and any other individuals who are
practitioners in the trauma field as designated by the
Director of the National Institutes of Health.
(h) Definitions.--For purposes of this section:
(1) The term ``designated trauma center'' has the
meaning given such term in section 1231(1).
(2) The term ``Director'' means the Director of the
National Institutes of Health.
(3) The term ``trauma'' means any serious injury
that could result in loss of life or in significant
disability and that would meet pre-hospital triage
criteria for transport to a designated trauma center.
(4) The term ``traumatic brain injury'' means an
acquired injury to the brain. Such term does not
include brain dysfunction caused by congenital or
degenerative disorders, nor birth trauma, but may
include brain injuries caused by anoxia due to trauma.
The Secretary may revise the definition of such term as
the Secretary determines necessary, after consultation
with States and other appropriate public or nonprofit
private entities.
(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2001 through 2005, and such sums as may be
necessary for each of the fiscal years 2009 through 2012.
Part G--Poison Control
SEC. 1271. [300D-71] MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER.
(a) In General.--The Secretary shall provide coordination
and assistance to poison control centers for the establishment
of a nationwide toll-free phone number, and the maintenance of
such number, to be used to access such centers.
(b) Authorization of Appropriations.--There is authorized
to be appropriated $2,000,000 for fiscal year 2009 to carry out
this section, and $700,000 for each of fiscal years 2010
through 2014 for the maintenance of the nationwide toll free
phone number under subsection (a).
SEC. 1272. [300D-72] NATIONWIDE MEDIA CAMPAIGN TO PROMOTE POISON
CONTROL CENTER UTILIZATION.
(a) In General.--The Secretary shall carry out, and expand
upon, a national media campaign to educate the public and
health care providers about poison prevention and the
availability of poison control center resources in local
communities and to conduct advertising campaigns concerning the
nationwide toll-free number established under section 1271(a).
(b) Contract With Entity.--The Secretary may carry out
subsection (a) by entering into contracts with one or more
public or private entities, including nationally recognized
organizations in the field of poison control and national media
firms, for the development and implementation of a nationwide
poison prevention and poison control center awareness campaign,
which may include--
(1) the development and distribution of poison
prevention and poison control center awareness
materials;
(2) television, radio, Internet, and newspaper
public service announcements; and
(3) other activities to provide for public and
professional awareness and education.
(c) Evaluation.--The Secretary shall--
(1) establish baseline measures and benchmarks to
quantitatively evaluate the impact of the nationwide
media campaign carried out under this section; and
(2) on an annual basis, prepare and submit to the
appropriate committees of Congress, \1\ an evaluation
of the nationwide media campaign.
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\1\ The comma after ``Congress'' probably should not appear.
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(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, such sums as may
be necessary for fiscal year 2009, and $800,000 for each of
fiscal years 2010 through 2014.
SEC. 1273. [300D-73] MAINTENANCE OF THE POISON CONTROL CENTER GRANT
PROGRAM.
(a) Authorization of Program.--The Secretary shall award
grants to poison control centers certified under subsection (c)
(or granted a waiver under subsection (d)) and professional
organizations in the field of poison control for the purposes
of preventing, and providing treatment recommendations for,
poisonings and complying with the operational requirements
needed to sustain the certification of the center under
subsection (c).
(b) Additional Uses of Funds.--In addition to the purposes
described in subsection (a), a poison center or professional
organization awarded a grant, contract, or cooperative
agreement under such subsection may also use amounts received
under such grant, contract, or cooperative agreement--
(1) to establish and evaluate best practices in the
United States for poison prevention, poison control
center outreach, and emergency and preparedness
programs;
(2) to research, develop, implement, revise, and
communicate standard patient management guidelines for
commonly encountered toxic exposures;
(3) to improve national toxic exposure surveillance
by enhancing cooperative activities between poison
control centers in the United States and the Centers
for Disease Control and Prevention;
(4) to develop, support, and enhance technology and
capabilities of professional organizations in the field
of poison control to collect national poisoning, toxic
occurrence, and related public health data;
(5) to develop initiatives to foster the enhanced
public health utilization of national poison data
collected by organizations described in paragraph (4);
(6) to support and expand the toxicologic expertise
within poison control centers; and
(7) to improve the capacity of poison control
centers to answer high volumes of calls and respond
during times of national crisis or other public health
emergencies.
(c) Certification.--Except as provided in subsection (d),
the Secretary may award a grant to a poison control center
under subsection (a) only if--
(1) the center has been certified by a professional
organization in the field of poison control, and the
Secretary has approved the organization as having in
effect standards for certification that reasonably
provide for the protection of the public health with
respect to poisoning; or
(2) the center has been certified by a State
government, and the Secretary has approved the State
government as having in effect standards for
certification that reasonably provide for the
protection of the public health with respect to
poisoning.
(d) Waiver of Certification Requirements.--
(1) In general.--The Secretary may grant a waiver
of the certification requirements of subsection (c)
with respect to a noncertified poison control center
that applies for a grant under this section if such
center can reasonably demonstrate that the center will
obtain such a certification within a reasonable period
of time as determined appropriate by the Secretary.
(2) Renewal.--The Secretary may renew a waiver
under paragraph (1).
(3) Limitation.--In no case may the sum of the
number of years for a waiver under paragraph (1) and a
renewal under paragraph (2) exceed 5 years. The
preceding sentence shall take effect as of the date of
the enactment of the Poison Center Support,
Enhancement, and Awareness Act of 2008.
(e) Supplement Not Supplant.--Amounts made available to a
poison control center under this section shall be used to
supplement and not supplant other Federal, State or local funds
provided for such center.
(f) Maintenance of Effort.--A poison control center, in
utilizing the proceeds of a grant under this section, shall
maintain the expenditures of the center for activities of the
center at a level that is not less than the level of
expenditures maintained by the center for the fiscal year
preceding the fiscal year for which the grant is received.
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $27,500,000 for
fiscal year 2009, and $28,600,000 for each of fiscal years 2010
through 2014. The Secretary may utilize not to exceed 8 percent
of the amount appropriated under this preceding sentence in
each fiscal year for coordination, dissemination, technical
assistance, program evaluation, data activities, and other
program administration functions that do not include grants,
contracts, or cooperative agreements under subsections (a) and
(b), which are determined by the Secretary to be appropriate
for carrying out the program under this section.
SEC. 1274. [300D-74] RULE OF CONSTRUCTION.
Nothing in this part may be construed to ease any
restriction in Federal law applicable to the amount or
percentage of funds appropriated to carry out this part that
may be used to prepare or submit a report.
PART H--TRAUMA SERVICE AVAILABILITY
SEC. 1281. [300D-81] GRANTS TO STATES.
(a) Establishment.--To promote universal access to trauma
care services provided by trauma centers and trauma-related
physician specialties, the Secretary shall provide funding to
States to enable such States to award grants to eligible
entities for the purposes described in this section.
(b) Awarding of Grants by States.--Each State may award
grants to eligible entities within the State for the purposes
described in subparagraph (d).
(c) Eligibility.--
(1) In general.--To be eligible to receive a grant
under subsection (b) an entity shall--
(A) be--
(i) a public or nonprofit trauma
center or consortium thereof that meets
that requirements of paragraphs (1),
(2), and (5) of section 1241(b);
(ii) a safety net public or
nonprofit trauma center that meets the
requirements of paragraphs (1) through
(5) of section 1241(b); or
(iii) a hospital in an underserved
area (as defined by the State) that
seeks to establish new trauma services;
and
(B) submit to the State an application at
such time, in such manner, and containing such
information as the State may require.
(2) Limitation.--A State shall use at least 40
percent of the amount available to the State under this
part for a fiscal year to award grants to safety net
trauma centers described in paragraph (1)(A)(ii).
(d) Use of Funds.--The recipient of a grant under
subsection (b) shall carry out 1 or more of the following
activities consistent with subsection (b):
(1) Providing trauma centers with funding to
support physician compensation in trauma-related
physician specialties where shortages exist in the
region involved, with priority provided to safety net
trauma centers described in subsection (c)(1)(A)(ii).
(2) Providing for individual safety net trauma
center fiscal stability and costs related to having
service that is available 24 hours a day, 7 days a
week, with priority provided to safety net trauma
centers described in subsection (c)(1)(A)(ii) located
in urban, border, and rural areas.
(3) Reducing trauma center overcrowding at specific
trauma centers related to throughput of trauma
patients.
(4) Establishing new trauma services in underserved
areas as defined by the State.
(5) Enhancing collaboration between trauma centers
and other hospitals and emergency medical services
personnel related to trauma service availability.
(6) Making capital improvements to enhance access
and expedite trauma care, including providing helipads
and associated safety infrastructure.
(7) Enhancing trauma surge capacity at specific
trauma centers.
(8) Ensuring expedient receipt of trauma patients
transported by ground or air to the appropriate trauma
center.
(9) Enhancing interstate trauma center
collaboration.
(e) Limitation.--
(1) In general.--A State may use not more than 20
percent of the amount available to the State under this
part for a fiscal year for administrative costs
associated with awarding grants and related costs.
(2) Maintenance of effort.--The Secretary may not
provide funding to a State under this part unless the
State agrees that such funds will be used to supplement
and not supplant State funding otherwise available for
the activities and costs described in this part.
(f) Distribution of Funds.--The following shall apply with
respect to grants provided in this part:
(1) Less than $10,000,000.--If the amount of
appropriations for this part in a fiscal year is less
than $10,000,000, the Secretary shall divide such
funding evenly among only those States that have 1 or
more trauma centers eligible for funding under section
1241(b)(3)(A).
(2) Less than $20,000,000.--If the amount of
appropriations in a fiscal year is less than
$20,000,000, the Secretary shall divide such funding
evenly among only those States that have 1 or more
trauma centers eligible for funding under subparagraphs
(A) and (B) of section 1241(b)(3).
(3) Less than $30,000,000.--If the amount of
appropriations for this part in a fiscal year is less
than $30,000,000, the Secretary shall divide such
funding evenly among only those States that have 1 or
more trauma centers eligible for funding under section
1241(b)(3).
(4) $30,000,000 or more.--If the amount of
appropriations for this part in a fiscal year is
$30,000,000 or more, the Secretary shall divide such
funding evenly among all States.
SEC. 1282. [300D-82] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there is
authorized to be appropriated $100,000,000 for each of fiscal
years 2010 through 2015.ATTORNEY: pmg/FD (June 28,
1999) deg.
TITLE XIII--HEALTH MAINTENANCE ORGANIZATIONS
requirements for health maintenance organizations
Sec. 1301. [300e] (a) For purposes of this title, the term
``health maintenance organization'' means a public or private
entity which is organized under the laws of any State and which
(1) provides basic and supplemental health services to its
members in the manner prescribed by subsection (b), and (2) is
organized and operated in the manner prescribed by subsection
(c).
(b) A health maintenance organization shall provide,
without limitations as to time or cost other than those
prescribed by or under this title, basic and supplemental
health services to its members in the following manner:
(1) Each member is to be provided basic health
services for a basic health services payment which (A)
is to be paid on a periodic basis without regard to the
dates health services (within the basic health
services) are provided; (B) is fixed without regard to
the frequency, extent, or kind of health service
(within the basic health services) actually furnished;
(C) except in the case of basic health services
provided a member who is a full-time student (as
defined by the Secretary) at an accredited institution
of higher education, is fixed under a community rating
system; and (D) may be supplemented by additional
nominal payments which may be required for the
provision of specific services (within the basic health
services), except that such payments may not be
required where or in such a manner that they serve (as
determined under regulations of the Secretary) as a
barrier to the delivery of health services. Such
additional nominal payments shall be fixed in
accordance with the regulations of the Secretary. If a
health maintenance organization offers to its members
the opportunity to obtain basic health services through
a physician not described in subsection (b)(3)(A), the
organization may require, in addition to payments
described in clause (D) of this paragraph, a reasonable
deductible to be paid by a member when obtaining a
basic health service from such a physician. A health
maintenance organization may include a health service,
defined as a supplemental health service by section
1302(2), in the basic health services provided its
members for a basic health services payment described
in the first sentence. In the case of an entity which
before it became a qualified health maintenance
organization (within the meaning of section 1310(d))
provided comprehensive health services on a prepaid
basis, the requirement of clause (C) shall not apply to
such entity until the expiration of the forty-eight
month period beginning with the month following the
month in which the entity became such a qualified
health organization. The requirements of this paragraph
respecting the basic health services payment shall not
apply to the provision of basic health services to a
member for an illness or injury for which the member is
entitled to benefits under a workmen's compensation law
or an insurance policy but only to the extent such
benefits apply to such services. For the provision of
such services for an illness or injury for which a
member is entitled to benefits under such a law, the
health maintenance organization may, if authorized by
such law, charge or authorize the provider of such
services to charge, in accordance with the charges
allowed under such law, the insurance carrier,
employer, or other entity which under such law is to
pay for the provision of such services or, to the
extent that such member has been paid under such law
for such services, such member. For the provision of
such services for an illness or injury for which a
member is entitled to benefits under an insurance
policy, a health maintenance organization may charge or
authorize the provider of such services to charge the
insurance carrier under such policy or, to the extent
that such member has been paid under such policy for
such services, such member.
(2) For such payment or payments (hereinafter in
this title referred to as ``supplemental health
services payments'') as the health maintenance
organization may require in addition to the basic
health services payment, the organization may provide
to each of its members any of the health services which
are included in supplemental health services (as
defined in section 1302(2)). Supplemental health
services payments which are fixed on a prepayment basis
shall be fixed under a community rating system unless
the supplemental health services payment is for a
supplemental health service provided a member who is a
full-time student (as defined by the Secretary) at an
accredited institution of higher education, except
that, in the case of an entity which before it became a
qualified health maintenance organization (within the
meaning of section 1310(d)) provided comprehensive
health services on a prepaid basis, the requirement of
this sentence shall not apply to such entity during the
forty-eight month period beginning with the month
following the month in which the entity became such a
qualified health maintenance organization.
(3)(A) Except as provided in subparagraph (B), at
least 90 percent of the services of a physician which
are provided as basic health services shall be provided
through--
(i) members of the staff of the health
maintenance organization,
(ii) a medical group (or groups),
(iii) an individual practice association
(or associations),
(iv) physicians or other health
professionals who have contracted with the
health maintenance organization for the
provision of such services, or
(v) any combination of such staff, medical
group (or groups), individual practice
association (or associations) or physicians or
other health professionals under contract with
the organization.
(B) Subparagraph (A) does not apply to the
provision of the services of a physician--
(i) which the health maintenance
organization determines, in conformity with
regulations of the Secretary, are unusual or
infrequently used, or
(ii) which are provided a member of the
organization in a manner other than that
prescribed by subparagraph (A) because of an
emergency which made it medically necessary
that the service be provided to the member
before it could be provided in a manner
prescribed by subparagraph (A).
(C) Contracts between a health maintenance
organization and health professionals for the provision
of basic and supplemental health services shall include
such provisions as the Secretary may require (including
provisions requiring appropriate continuing education).
(D) Contracts between a health maintenance
organization and health professionals for the provision
of basic and supplemental health services shall include
such provisions as the Secretary may require, but only
to the extent that such requirements are designed to
insure the delivery of quality health care services and
sound fiscal management.
(4) Basic health services (and only such
supplemental health services as members have contracted
for) shall within the area served by the health
maintenance organization be available and accessible to
each of its members with reasonable promptness and in a
manner which assures continuity, and when medically
necessary be available and accessible twenty-four hours
a day and seven days a week, except that a health
maintenance organization which has a service area
located wholly in a nonmetropolitan area may make a
basic health service available outside its service area
if that basic health service is not a primary care or
emergency health care service and if there is an
insufficient number of providers of that basic health
service within the service area who will provide such
service to members of the health maintenance
organization. A member of a health maintenance
organization shall be reimbursed by the organization
for his expenses in securing basic and supplemental
health services other than through the organization if
the services were medically necessary and immediately
required because of an unforeseen illness, injury, or
condition.
(5) To the extent that a natural disaster, war,
riot, civil insurrection, or any other similar event
not within the control of a health maintenance
organization (as determined under regulations of the
Secretary) results in the facilities, personnel, or
financial resources of a health maintenance
organization not being available to provide or arrange
for the provision of a basic or supplemental health
service in accordance with the requirements of
paragraphs (1) through (4) of this subsection, such
requirements only require the organization to make a
good-faith effort to provide or arrange for the
provision of such service within such limitation on its
facilities, personnel, or resources.
(6) A health maintenance organization that
otherwise meets the requirements of this title may
offer a high-deductible health plan (as defined in
section 220(c)(2) of the Internal Revenue Code of
1986).
(c) Each health maintenance organization shall--
(1)(A) have--
(i) a fiscally sound operation, and
(ii) adequate provision against the risk of
insolvency,
which is satisfactory to the Secretary, and (B) have
administrative and managerial arrangements satisfactory
to the Secretary;
(2) assume full financial risk on a prospective
basis for the provision of basic health services,
except that a health maintenance organization may (A)
obtain insurance or make other arrangements for the
cost of providing to any member basic health services
the aggregate value of which exceeds $5,000 in any
year, (B) obtain insurance or make other arrangements
for the cost of basic health services provided to its
members other than through the organization because
medical necessity required their provision before they
could be secured through the organization, (C) obtain
insurance or make other arrangements for not more than
90 per centum of the amount by which its costs for any
of its fiscal years exceed 115 per centum of its income
for such fiscal year, and (D) make arrangements with
physicians or other health professionals, health care
institutions, or any combination of such individuals or
institutions to assume all or part of the financial
risk on a prospective basis for the provision of basic
health services by the physicians or other health
professionals or through the institutions;
(3)(A) enroll persons who are broadly
representative of the various age, social, and income
groups within the area it serves, except that in the
case of a health maintenance organization which has a
medically underserved population located (in whole or
in part) in the area it serves, not more than 75 per
centum of the members of that organization may be
enrolled from the medically underserved population
unless the area in which such population resides is
also a rural area (as designated by the Secretary), and
(B) carry out enrollment of members who are entitled to
medical assistance under a State plan approved under
title XIX of the Social Security Act in accordance with
procedures approved under regulations promulgated by
the Secretary;
(4) not expel or refuse to re-enroll any member
because of his health status or his requirements for
health services;
(5) be organized in such a manner that provides
meaningful procedures for hearing and resolving
grievances between the health maintenance organization
(including the medical group or groups and other health
delivery entities providing health services for the
organization) and the members of the organization;
(6) have organizational arrangements, established
in accordance with regulations of the Secretary, for an
ongoing quality assurance program for its health
services which program (A) stresses health outcomes,
and (B) provides review by physicians and other health
professionals of the process followed in the provision
of health services;
(7) adopt at least one of the following
arrangements to protect its members from incurring
liability for payment of any fees which are the legal
obligation of such organization--
(A) a contractual arrangement with any
hospital that is regularly used by the members
of such organization prohibiting such hospital
from holding any such member liable for payment
of any fees which are the legal obligation of
such organization;
(B) insolvency insurance, acceptable to the
Secretary;
(C) adequate financial reserve, acceptable
to the Secretary; and
(D) other arrangements, acceptable to the
Secretary, to protect members,
except that the requirements of this paragraph shall not apply
to a health maintenance organization if applicable State law
provides the members of such organization with protection from
liability for payment of any fees which are the legal
obligation of such organization; and
(8) provide, in accordance with regulations of the
Secretary (including safeguards concerning the confidentiality
of the doctor-patient relationship), an effective procedure for
developing, compiling, evaluating, and reporting to the
Secretary, statistics and other information (which the
Secretary shall publish and disseminate on an annual basis and
which the health maintenance organization shall disclose, in a
manner acceptable to the Secretary, to its members and the
general public) relating to (A) the cost of its operations, (B)
the patterns of utilization of its services, (C) the
availability, accessibility, and acceptability of its services,
(D) to the extent practical, developments in the health status
of its members, and (E) such other matters as the Secretary may
require.
The Secretary shall issue regulations stating the circumstances
under which the Secretary, in administering paragraph (1)(A),
will consider the resources of an organization which owns or
controls a health maintenance organization. Such regulations
shall require as a condition to consideration of resources that
an organization which owns or controls a health maintenance
organization shall provide satisfactory assurances that it will
assume the financial obligations of the health maintenance
organization.
(d) An organization that offers health benefits coverage
shall not be considered as failing to meet the requirements of
this section notwithstanding that it provides, with respect to
coverage offered in connection with a group health plan in the
small or large group market (as defined in section 2791(e)), an
affiliation period consistent with the provisions of section
2701(g).
definitions
Sec. 1302. [300e-1] For purposes of this title:
(1) The term ``basic health services'' means--
(A) physician services (including consultant and
referral services by a physician);
(B) inpatient and outpatient hospital services;
(C) medically necessary emergency health services;
(D) short-term (not to exceed twenty visits),
outpatient evaluative and crisis intervention mental
health services;
(E) medical treatment and referral services
(including referral services to appropriate ancillary
services) for the abuse of or addiction to alcohol and
drugs;
(F) diagnostic laboratory and diagnostic and
therapeutic radiologic services;
(G) home health services; and
(H) preventive health services (including (i)
immunizations, (ii) well-child care from birth, (iii)
periodic health evaluations for adults, (iv) voluntary
family planning services, (v) infertility services, and
(vi) children's eye and ear examinations conducted to
determine the need for vision and hearing correction).
Such term does not include a health service which the
Secretary, upon application of a health maintenance
organization, determines is unusual and infrequently provided
and not necessary for the protection of individual health. The
Secretary shall publish in the Federal Register each
determination made by him under the preceding sentence. If a
service of a physician described in the preceding sentence may
also be provided under applicable State law by a dentist,
optometrist, podiatrist, psychologist, or other health care
personnel a health maintenance organization may provide such
service through a dentist, optometrist, podiatrist,
psychologist, or other health care personnel (as the case may
be) licensed to provide such service. Such term includes a
health service directly associated with an organ transplant
only if such organ transplant was required to be included in
basic health services on April 15, 1985. For purposes of this
paragraph, the term ``home health services'' means health
services provided at a member's home by health care personnel,
as prescribed or directed by the responsible physician or other
authority designated by the health maintenance organization.
(2) The term ``supplemental health services'' means any
health service which is not included as a basic health service
under paragraph (1) of this section. If a health service
provided by a physician may also be provided under applicable
State law by a dentist, optometrist, podiatrist, psychologist,
or other health care personnel, a health maintenance
organization may provide such service through an optometrist,
dentist, podiatrist, psychologist, or other health care
personnel (as the case may be) licensed to provide such
service.
(3) The term ``member'' when used in connection with a
health maintenance organization means an individual who has
entered into a contractual agreement, or on whose behalf a
contractual arrangement has been entered into, with the
organization under which the organization assumes the
responsibility for the provision to such individual of basic
health services and of such supplemental health services as may
be contracted for.
(4) The term ``medical group'' means a partnership,
association, or other group--
(A) which is composed of health professionals
licensed to practice medicine or osteopathy and of such
other licensed health professionals (including
dentists, optometrists, podiatrists, and psychologists)
as are necessary for the provision of health services
for which the group is responsible;
(B) a majority of the members of which are licensed
to practice medicine or osteopathy; and
(C) the members of which (i) as their principal
professional activity engage in the coordinated
practice of their profession and as a group
responsibility have substantial responsibility for the
delivery of health services to members of a health
maintenance organization, except that this clause does
not apply before the end of the forty-eight month
period beginning after the month in which the health
maintenance oranization \1\ becomes a qualified health
maintenance organization as defined in section 1310(d),
or as authorized by the Secretary in accordance with
regulations that take into consideration the usual
circumstances of the group; (ii) pool their income from
practice as members of the group and distribute it
among themselves according to a prearranged salary or
drawing account or other similar plan unrelated to the
provision of specific health services; (iii) share
medical and other records and substantial portions of
major equipment and of professional, technical, and
administrative staff; (iv) arrange for and encourage
continuing education in the field of clinical medicine
and related areas for the members of the group; and (v)
establish an arrangement whereby a member's enrollment
status is not known to the health professional who
provides health services to the member.
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\1\ So in law. Probably should be ``organization''.
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(5) The term ``individual practice association'' means a
partnership, corporation, association, or other legal entity
which has entered into a services arrangement (or arrangements)
with persons who are licensed to practice medicine, osteopathy,
dentistry, podiatry, optometry, psychology, or other health
profession in a State and a majority of whom are licensed to
practice medicine or osteopathy. Such an arrangement shall
provide--
(A) that such persons shall provide their
professional services in accordance with a compensation
arrangement established by the entity; and
(B) to the extent feasible, for the sharing by such
persons of medical and other records, equipment, and
professional, technical, and administrative staff.
(6) The term ``health systems agency'' means an entity
which is designated in accordance with section 1515 of this
Act.
(7) The term ``medically underserved population'' means the
population of an urban or rural area designated by the
Secretary as an area with a shortage of personal health
services or a population group designated by the Secretary as
having a shortage of such services. Such a designation may be
made by the Secretary only after consideration of the comments
(if any) of (A) each State health planning and development
agency which covers (in whole or in part) such urban or rural
area or the area in which such population group resides, and
(B) each health systems agency designated for a health service
area which covers (in whole or in part) such urban or rural
area or the area in which such population group resides.
(8)(A) The term ``community rating system'' means the
systems, described in subparagraphs (B) and (C), of fixing
rates of payments for health services. A health maintenance
organization may fix its rates of payments under the system
described in subparagraph (B) or (C) or under both such
systems, but a health maintenance organization may use only one
such system for fixing its rates of payments for any one group.
(B) A system of fixing rates of payment for health services
may provide that the rates shall be fixed on a per-person or
per-family basis and may authorize the rates to vary with the
number of persons in a family, but, except as authorized in
subparagraph (D), such rates must be equivalent for all
individuals and for all families of similar composition.
(C) A system of fixing rates of payment for health services
may provide that the rates shall be fixed for individuals and
families by groups. Except as authorized in subparagraph (D),
such rates must be equivalent for all individuals in the same
group and for all families of similar composition in the same
group. If a health maintenance organization is to fix rates of
payment for individuals and families by groups, it shall--
(i)(I) classify all of the members of the
organization into classes based on factors
which the health maintenance organization
determines predict the differences in the use
of health services by the individuals or
families in each class and which have not been
disapproved by the Secretary,
(II) determine its revenue requirements for
providing services to the members of each class
established under subclause (I), and
(III) fix the rates of payments for the
individuals and families of a group on the
basis of a composite of the organization's
revenue requirements determined under subclause
(II) for providing services to them as members
of the classes established under subclause (I),
or
(ii) fix the rates of payments for the
individuals and families of a group on the
basis of the organization's revenue
requirements for providing services to the
group, except that the rates of payments for
the individuals and families of a group of less
than 100 persons may not be fixed at rates
greater than 110 percent of the rate that would
be fixed for such individuals and families
under subparagraph (B) or clause (i) of this
subparagraph.
The Secretary shall review the factors used by each health
maintenance organization to establish classes under clause (i).
If the Secretary determines that any such factor may not
reasonably be used to predict the use of the health services by
individuals and families, the Secretary shall disapprove such
factor for such purpose. If a health maintenance organization
is to fix rates of payment for a group under clause (ii), it
shall, upon request of the entity with which it contracts to
provide services to such group, disclose to that entity the
method and data used in calculating the rates of payment.
(D) The following differentials in rates of payments may be
established under the systems described in subparagraphs (B)
and (C):
(i) Nominal differentials in such rates may be
established to reflect differences in marketing costs
and the different administrative costs of collecting
payments from the following categories of members:
(I) Individual members (including their
families).
(II) Small groups of members (as determined
under regulations of the Secretary).
(III) Large groups of members (as
determined under regulations of the Secretary).
(ii) Nominal differentials in such rates may be
established to reflect the compositing of the rates of
payment in a systematic manner to accommodate group
purchasing practices of the various employers.
(iii) Differentials in such rates may be
established for members enrolled in a health
maintenance organization pursuant to a contract with a
governmental authority under section 1079 or 1086 of
title 10, United States Code, or under any other
governmental program (other than the health benefits
program authorized by chapter 89 of title 5, United
States Code) or any health benefits program for
employees of States, political subdivision of States,
and other public entities.
(9) The term ``non-metropolitan area'' means an area no
part of which is within an area designated as a standard
metropolitan statistical area by the Office of Management and
Budget and which does not contain a city whose population
exceeds fifty thousand individuals.
loans and loan guarantees for initial costs of operation
Sec. 1305. [300e-4] (a) The Secretary may--
(1) make loans to public or private health
maintenance organizations to assist them in meeting the
amount by which their costs of operation during a
period not to exceed the first sixty months of their
operation exceed their revenues in that period;
(2) make loans to public or private health
maintenance organizations to assist them in meeting the
amount by which their costs of operation, which the
Secretary determines are attributable to significant
expansion in their membership or area served and which
are incurred during a period not to exceed the first
sixty months of their operation after such expansion,
exceed their revenues in that period which the
Secretary determines are attributable to such
expansion; and
(3) guarantee to non-Federal lenders payment of the
principal of and the interest on loans made to private
health maintenance organizations for the amounts
referred to in paragraphs (1) and (2).
No loan or loan guarantee may be made under this subsection for
the costs of operation of a health maintenance organization
unless the Secretary determines that the organization has made
all reasonable attempts to meet such costs, and unless the
Secretary has made a grant or loan to, entered into a contract
with, or guaranteed a loan for, the organization in fiscal year
1981, 1982, 1983, 1984, or 1985 under this section or section
1304(b) (as in effect before October 1, 1985).
(b)(1) Except as provided in paragraph (2), the aggregate
amount of principal of loans made or guaranteed, or both, under
subsection (a) for a health maintenance organization may not
exceed $7,000,000. In any twelve-month period the amount
disbursed to a health maintenance organization under this
section (either directly by the Secretary, by an escrow agent
under the terms of an escrow agreement, or by a lender under a
guaranteed loan) may not exceed $3,000,000.
(2) The cumulative total of the principal of the loans
outstanding at any time which have been directly made or with
respect to which guarantees have been issued under subsection
(a) may not exceed such limitations as may be specified in
appropriation Acts.
(c) Loans under this section shall be made from the fund
established under section 1308(e).
(d) No loan may be made or guaranteed under this section
after September 30, 1986.
(e) Of the sums used for loans under this section in any
fiscal year from the loan fund established under section
1308(e), not less than 20 per centum shall be used for loans
for projects (1) for the initial operation of health
maintenance organizations which the Secretary determines have
not less than 66 per centum of their membership drawn from
residents of nonmetropolitan areas, and (2) the applications
for which meet the requirements of this title for approval.
(f) In considering applications for loan guarantees under
this section, the Secretary shall give special consideration to
applications for health maintenance organizations which will
serve medically underserved populations.
application requirements
Sec. 1306. [300e-5] (a) No loan or loan guarantee may be
made under this title unless an application therefor has been
submitted to and approved by the Secretary.
(b) The Secretary may not approve an application for a loan
or loan guarantee under this title unless--
(1) such application meets the requirements of
section 1308;
(2) in the case of an application for assistance
under section 1305, he determines that the applicant
making the application would not be able to complete
the project or undertaking for which the application is
submitted without the assistance applied for;
(3) the application contains satisfactory
specification of the existing or anticipated (A)
population group or groups to be served by the proposed
or existing health maintenance organization described
in the application, (B) membership of such
organization, (C) methods, terms, and periods of the
enrollment of members of such organization, (D)
estimated costs per member of the health and
educational services to be provided by such
organization and the nature of such costs, (E) sources
of professional services for such organization, and
organizational arrangements of such organization for
providing health and educational services, (F)
organizational arrangements of such organization for an
ongoing quality assurance program in conformity with
the requirements of section 1301(c), (G) sources of
prepayment and other forms of payment for the services
to be provided by such organization, (H) facilities,
and additional capital investments and sources of
financing therefor, available to such organization to
provide the level and scope of services proposed, (I)
administrative, managerial, and financial arrangements
and capabilities of such organization, (J) role for
members in the planning and policymaking for such
organization, (K) grievance procedures for members of
such organization, and (L) evaluations of the support
for and acceptance of such organization by the
population to be served, the sources of operating
support, and the professional groups to be involved or
affected thereby;
(4) contains or is supported by assurances
satisfactory to the Secretary that the applicant making
the application will, in accordance with such criteria
as the Secretary shall by regulation prescribe, enroll,
and maintain an enrollment of the maximum number of
members that its available and potential resources (as
determined under regulations of the Secretary) will
enable it to effectively serve;
(5) in the case of an application made for a
project which previously received a grant, contract,
loan, or loan guarantee under this title, such
application contains or is supported by assurances
satisfactory to the Secretary that the applicant making
the application has the financial capability to
adequately carry out the purposes of such project and
has developed and operated such project in accordance
with the requirements of this title and with the plans
contained in previous applications for such assistance;
(6) the application contains such assurances as the
Secretary may require respecting the intent and the
ability of the applicant to meet the requirements of
paragraphs (1) and (2) of section 1301(b) respecting
the fixing of basic health services payments and
supplemental health services payments under a community
rating system; and
(7) the application is submitted in such form and
manner, and contains such additional information, as
the Secretary shall prescribe in regulations.
An organization making multiple applications for more than one
loan or loan guarantee under this title, simultaneously or over
the course of time, shall not be required to submit duplicate
or redundant information but shall be required to update the
specifications (required by paragraph (3)) respecting the
existing or proposed health maintenance organization in such
manner and with such frequency as the Secretary may by
regulation prescribe. In determining, for purposes of paragraph
(2), whether an applicant would be able to complete a project
or undertaking without the assistance applied for, the
Secretary shall not consider any asset of the applicant the
obligation of which for such undertaking or project would
jeopardize the fiscal soundness of the applicant.
(c) The Secretary shall by regulation establish standards
and procedures for health systems agencies to follow in
reviewing and commenting on applications for loans and loan
guarantees under this title.
administration of assistance programs
Sec. 1307. [300e-6] (a)(1) Each recipient of a loan or loan
guarantee under this title shall keep such records as the
Secretary shall prescribe, including records which fully
disclose the amount and disposition by such recipient of the
proceeds of the loan (directly made or guaranteed), the total
cost of the undertaking in connection with which the loan was
given or used, the amount of that portion of the cost of the
undertaking supplied by other sources, and such other records
as will facilitate an effective audit.
(2) The Secretary, or any of his duly authorized
representatives, shall have access for the purpose of audit and
examination to any books, documents, papers, and records of the
recipients of a loan or loan guarantee under this title which
relate to such assistance.
(b) Upon expiration of the period for which a loan or loan
guarantee was provided an entity under this title, such entity
shall make a full and complete report to the Secretary in such
manner as he may by regulation prescribe. Each such report
shall contain, among such other matters as the Secretary may by
regulation require, descriptions of plans, developments, and
operations relating to the matters referred to in section
1306(b)(3).
(d) \1\ An entity which provides health services to a
defined population on a prepaid basis and which has members who
are entitled to insurance benefits under title XVIII of the
Social Security Act or to medical assistance under a State plan
approved under title XIX of such Act may be considered as a
health maintenance organization for purposes of receiving
assistance under this title if--
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\1\ Former subsection (c) was repealed by section 803(a) of Public
Law 99-660.
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(1) with respect to its members who are entitled to
such insurance benefits or to such medical assistance
it (A) provides health services in accordance with
section 1301(b), except that (i) it does not furnish to
those members the health services (within the basic
health services) for which it may not be compensated
under such title XVIII or such State plan, and (ii) it
does not fix the basic or supplemental health services
payment for such members under a community rating
system, and (B) is organized and operated in the manner
prescribed by section 1301(c), except that it does not
assume full financial risk on a prospective basis for
the provision to such members of basic or supplemental
health services with respect to which it is not
required under such title XVIII or such State plan to
assume such financial risk; and
(2) with respect to its other members it provides
health services in accordance with section 1301(b) and
is organized and operated in the manner prescribed by
section 1301(c).
An entity which provides health services to a defined
population on a prepaid basis and which has members who are
enrolled under the health benefits program authorized by
chapter 89 of title 5, United States Code, may be considered as
a health maintenance organization for purposes of receiving
assistance under this title if with respect to its other
members it provides health services in accordance with section
1301(b) and is organized and operated in the manner prescribed
by section 1301(c).
general provisions relating to loan guarantees and loans
Sec. 1308. [300e-7] (a)(1) The Secretary may not approve an
application for a loan guarantee under this title unless he
determines that (A) the terms, conditions, security (if any),
and schedule and amount of repayments with respect to the loan
are sufficient to protect the financial interests of the United
States and are otherwise reasonable, including a determination
that the rate of interest does not exceed such per centum per
annum on the principal obligation outstanding as the Secretary
determines to be reasonable, taking into account the range of
interest rates prevailing in the private market for loans with
similar maturities, terms, conditions, and security and the
risks assumed by the United States, and (B) the loan would not
be available on reasonable terms and conditions without the
guarantee under this title.
(2)(A) The United States shall be entitled to recover from
the applicant for a loan guarantee under this title the amount
of any payment made pursuant to such guarantee, unless the
Secretary for good cause waives such right of recovery; and,
upon making any such payment, the United States shall be
subrogated to all of the rights of the recipient of the
payments with respect to which the guarantee was made.
(B) To the extent permitted by subparagraph (C), any terms
and conditions applicable to a loan guarantee under this title
(including terms and conditions imposed under subparagraph (D))
may be modified by the Secretary to the extent he determines it
to be consistent with the financial interest of the United
States.
(C) Any loan guarantee made by the Secretary under this
title shall be incontestable (i) in the hands of an applicant
on whose behalf such guarantee is made unless the applicant
engaged in fraud or misrepresentation in securing such
guarantee, and (ii) as to any person (or his successor in
interest) who makes or contracts to make a loan to such
applicant in reliance thereon unless such person (or his
successor in interest) engaged in fraud or misrepresentation in
making or contracting to make such loan.
(D) guarantees of loans under this title shall be subject
to such further terms and conditions as the Secretary
determines to be necessary to assure that the purposes of this
title will be achieved.
(b)(1) The Secretary may not approve an application for a
loan under this title unless--
(A) the Secretary is reasonably satisfied that the
applicant therefor will be able to make payments of
principal and interest thereon when due, and
(B) the applicant provides the Secretary with
reasonable assurances that there will be available to
it such additional funds as may be necessary to
complete the project or undertaking with respect to
which such loan is requested.
(2) Any loan made under this title shall (A) have such
security, (B) have such maturity date, (C) be repayable in such
installments, (D) on the date the loan is made, bear interest
at a rate comparable to the rate of interest prevailing on such
date with respect to marketable obligations of the United
States of comparable maturities, adjusted to provide for
appropriate administrative charges, and (E) be subject to such
other terms and conditions (including provisions for recovery
in case of default), as the Secretary determines to be
necessary to carry out the purposes of this title while
adequately protecting the financial interests of the United
States. On the date disbursements are made under a loan after
the initial disbursement under the loan, the Secretary may
change the rate of interest on the amount of the loan disbursed
on that date to a rate which is comparable to the rate of
interest prevailing on the date the subsequent disbursement is
made with respect to marketable obligations of the United
States of comparable maturities, adjusted to provide for
appropriate administrative charges.
(3) The Secretary may, for good cause but with due regard
to the financial interests of the United States, waive any
right of recovery which he has by reason of the failure of a
borrower to make payments of principal of and interest on a
loan made under this title, except that if such loan is sold
and guaranteed, any such waiver shall have no effect upon the
Secretary's guarantee of timely payment of principal and
interest.
(c)(1) The Secretary may from time to time, but with due
regard to the financial interests of the United States, sell
loans made by him under this title.
(2) The Secretary may agree, prior to his sale of any such
loan, to guarantee to the purchaser (and any successor in
interest of the purchaser) compliance by the borrower with the
terms and conditions of such loan. Any such agreement shall
contain such terms and conditions as the Secretary considers
necessary to protect the financial interests of the United
States or as otherwise appropriate. Any such agreement may (A)
provide that the Secretary shall act as agent of any such
purchaser for the purpose of collecting from the borrower to
which such loan was made and paying over to such purchaser, any
payments of principal and interest payable by such organization
under such loan; and (B) provide for the repurchase by the
Secretary of any such loan on such terms and conditions as may
be specified in the agreement. The full faith and credit of the
United States is pledged to the payment of all amounts which
may be required to be paid under any guarantee under this
paragraph.
(3) After any loan under this title to a public health
maintenance organization has been sold and guaranteed under
this subsection, interest paid on such loan which is received
by the purchaser thereof (or his successor in interest) shall
be included in the gross income of the purchaser of the loan
(or his successor in interest) for the purpose of chapter 1 of
the Internal Revenue Code of 1954.
(4) Amounts received by the Secretary as proceeds from the
sale of loans under this subsection shall be deposited in the
loan fund established under subsection (e).
(5) Any reference in this title (other than in this
subsection and in subsection (d)) to a loan guarantee under
this title does not include a loan guarantee made under this
subsection.
(d)(1) There is established in the Treasury a loan
guarantee fund (hereinafter in this subsection referred to as
the ``fund'') which shall be available to the Secretary without
fiscal year limitation, in such amounts as may be specified
from time to time in appropriation Acts, to enable him to
discharge his responsibilities under loan guarantees issued by
him under this title and to take the action authorized by
subsection (f). There are authorized to be appropriated from
time to time such amounts as may be necessary to provide the
sums required for the fund. To the extent authorized in
appropriation Acts, there shall also be deposited in the fund
amounts received by the Secretary in connection with loan
guarantees under this title and other property or assets
derived by him from his operations respecting such loan
guarantees, including any money derived from the sale of
assets.
(2) If at any time the sums in the funds are insufficient
to enable the Secretary to discharge his responsibilities under
guarantees issued by him before October 1, 1986, under this
title and to take the action authorized by subsection (f), he
is authorized to issue to the Secretary of the Treasury notes
or other obligations in such forms and denominations, bearing
such maturities, and subject to such terms and conditions, as
may be prescribed by the Secretary with the approval of the
Secretary of Treasury. Such notes or other obligations shall
bear interest at a rate determined by the Secretary of the
Treasury, taking into consideration the current average market
yield on outstanding marketable obligations of the United
States of comparable maturities during the month preceding the
issuance of the notes or other obligations. The Secretary of
the Treasury shall purchase any notes and other obligations
issued under this paragraph and for that purpose he may use as
a public debt transaction the proceeds from the sale of any
securities issued under the Second Liberty Bond Act, and the
purposes for which the securities may be issued under that Act
are extended to include any purchase of such notes and
obligations. The Secretary of the Treasury may at any time sell
any of the notes or other obligations acquired by him under
this paragraph. All redemptions, purchases, and sales by the
Secretary of the Treasury of such notes or other obligations
shall be treated as public debt transactions of the United
States. Sums borrowed under this paragraph shall be deposited
in the fund and redemption of such notes and obligations shall
be made by the Secretary from the fund.
(e) There is established in the Treasury a loan fund
(hereinafter in this subsection referred to as the ``fund'')
which shall be available to the Secretary without fiscal year
limitation, in such amounts as may be specified from time to
time in appropriation Acts, to enable him to make loans under
this title and to take the action authorized by subsection (f).
There shall also be deposited in the fund amounts received by
the Secretary as interest payments and repayment of principal
on loans made under this title and other property or assets
derived by him from his operations respecting such loans, from
the sale of loans under subsection (c) of this section, or from
the sale of assets.
(f) The Secretary may take such action as he deems
appropriate to protect the interest of the United States in the
event of a default on a loan made or guaranteed under this
title, including taking possession of, holding, and using real
property pledged as security for such a loan or loan guarantee.
authorizations of appropriations
Sec. 1309. [300e-8] (a) For grants under section 1317 there
is authorized to be appropriated $1,000,000 for each of the
fiscal years 1982, 1983, and 1984.
(b) To meet the obligations of the loan fund established
under section 1308(e) resulting from defaults on loans made
from the fund and to meet the other obligations of the fund,
there is authorized to be appropriated to the loan fund for
fiscal years 1987, 1988, and 1989, such sums as may be
necessary.
employees' health benefits plans
Sec. 1310. \1\ [300e-9] (a) In accordance with regulations
which the Secretary shall prescribe--
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\1\ Section 1310 as shown above was added by section 7(b) of Public
Law 100-517. Such section provided in part as follows: ``Effective 7
years after the date of the enactment of this Act [October 24, 1988],
section 1310 (42 U.S.C. 300e-9) is amended to read as follows''.
Section 7(a)(3) of such Public Law provides that nothing in section
1310 shall be construed to supersede any provision of a collective
bargaining agreement in effect on [October 24, 1988].
Section 9 of such Public Law provides as follows: ``With respect to
abortion services, the Secretary of Health and Human Services shall not
promulgate or issue any regulations, policy statements, or
interpretations or develop any practices concerning the performance of
medically necessary procedures if such regulations, policy statements,
interpretations, or practices would be inconsistent with those in
effect on [October 24, 1988].''.
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(1) each employer--
(A) which is required during any calendar
quarter to pay its employees the minimum wage
prescribed by section 6 of the Fair Labor
Standards Act of 1938 (or would be required to
pay its employees such wage but for section
13(a) of such Act), and
(B) which during such calendar quarter
employed an average number of employees of not
less than 25, and
(2) any State and each political subdivision
thereof which during any calendar quarter employed an
average number of employees of not less than 25, as a
condition of payment to the State of funds under
section 317, 318, or 1002,
which offers to its employees in the calendar year beginning
after such calendar quarter the option of membership in a
qualified health maintenance organization which is engaged in
the provision of basic health services in a health maintenance
organization service area in which at least 25 of such
employees reside shall meet the requirements of subsection (b)
with respect to any qualified health maintenance organization
offered by the employer or State or political subdivision.
(b)(1) If a health benefits plan offered by an employer or
a State or political subdivision includes contributions for
services offered under the plan, the employer or State or
political subdivision shall make a contribution under the plan
for services offered by a qualified health maintenance
organization in an amount which does not financially
discriminate against an employee who enrolls in such
organization. For purposes of the preceding sentence, an
employer's or a State's or political subdivision's contribution
does not financially discriminate if the employer's or State's
or political subdivision's method of determining the
contributions on behalf of all employees is reasonable and is
designed to assure employees a fair choice among health
benefits plans.
(2) Each employer or State or political subdivision which
provides payroll deductions as a means of paying employees'
contributions for health benefits or which provides a health
benefits plan to which an employee contribution is not required
shall, with the consent of an employee who exercises option of
membership in a qualified health maintenance organization,
arrange for the employee's contribution for membership in the
organization to be paid through payroll deductions.
(3) No employer or State or political subdivision shall be
required to pay more for health benefits as a result of the
application of this subsection than would otherwise be required
by any prevailing collective bargaining agreement or other
legally enforceable contract for the provision of health
benefits between the employer or State or political subdivision
and its employees.
(c) For purposes of this section, the term ``qualified
health maintenance organization'' means (1) a health
maintenance organization which has provided assurances
satisfactory to the Secretary that it provides basic and
supplemental health services to its members in the manner
prescribed by section 1301(b) and that it is organized and
operated in the manner prescribed by section 1301(c), and (2)
an entity which proposes to become a health maintenance
organization and which the Secretary determines will when it
becomes operational provide basic and supplemental health
services to its members in the manner prescribed by section
1301(b) and will be organized and operated in the manner
prescribed by section 1301(c).
(d)(1) Any employer who knowingly does not comply with one
or more of the requirements of paragraph (1) or (2) of
subsection (b) shall be subject to a civil penalty of not more
than $10,000. If such noncompliance continues, a civil penalty
may be assessed and collected under this subsection for each
thirty-day period such noncompliance continues. Such penalty
may be assessed by the Secretary and collected in a civil
action brought by the United States in a United States district
court.
(2) In any proceeding by the Secretary to assess a civil
penalty under this subsection, no penalty shall be assessed
until the employer charged shall have been given notice and an
opportunity to present its views on such charge. In determining
the amount of the penalty, or the amount agreed upon in
compromise, the Secretary shall consider the gravity of the
noncompliance and the demonstrated good faith of the employer
charged in attempting to achieve rapid compliance after
notification by the Secretary of a noncompliance.
(3) In any civil action brought to review the assessment of
a civil penalty assessed under this subsection, the court
shall, at the request of any party to such action, hold a trial
de novo on the assessment of such civil penalty and in any
civil action to collect such a civil penalty, the court shall,
at the request of any party to such action, hold a trial de
novo on the assessment of such civil penalty unless in a prior
civil action to review the assessment of such penalty the court
held a trial de novo on such assessment.
(e) For purposes of this section, the term ``employer''
does not include (1) the Government of the United States, the
government of the District of Columbia or any territory or
possession of the United States, a State or any political
subdivision thereof, or any agency or instrumentality
(including the United States Postal Service and Postal Rate
Commission) of any of the foregoing, except that such term
includes nonappropriated fund instrumentalities of the
Government of the United States; or (2) a church, convention or
association of churches, or any organization operated,
supervised or controlled by a church, convention or association
of churches which organization (A) is an organization described
in section 501(c)(3) of the Internal Revenue Code of 1986, and
(B) does not discriminate (i) in the employment, compensation,
promotion, or termination of employment of any personnel, or
(ii) in the extension of staff or other privileges to any
physician or other health personnel, because such persons seek
to obtain or obtained health care, or participate in providing
health care, through a health maintenance organization.
(f) If the Secretary, after reasonable notice and
opportunity for a hearing to a State, finds that it or any of
its political subdivisions has failed to comply with paragraph
(1) or (2) of subsection (b), the Secretary shall terminate
payments to such State under sections 317, 318, and 1002 and
notify the Governor of such State that further payments under
such sections will not be made to the State until the Secretary
is satisfied that there will no longer be any such failure to
comply.
restrictive state laws and practices
Sec. 1311. [300e-10] (a) In the case of any entity--
(1) which cannot do business as a health
maintenance organization in a State in which it
proposes to furnish basic and supplemental health
services because that State by law, regulation, or
otherwise--
(A) requires as a condition to doing
business in that State that a medical society
approve the furnishing of services by the
entity,
(B) requires that physicians constitute all
or a percentage of its governing body,
(C) requires that all physicians or a
percentage of physicians in the locale
participate or be permitted to participate in
the provision of services for the entity,
(D) requires that the entity meet
requirements for insurers of health care
services doing business in that State
respecting initial capitalization and
establishment of financial reserves against
insolvency, or
(E) imposes requirements which would
prohibit the entity from complying with the
requirements of this title, and
(2) for which a grant, contract, loan, or loan
guarantee was made under this title or which is a
qualified health maintenance organization for purposes
of section 1310 (relating to employees' health benefits
plans),
such requirements shall not apply to that entity so as to
prevent it from operating as a health maintenance organization
in accordance with section 1301.
(b) No State may establish or enforce any law which
prevents a health maintenance organization for which a grant,
contract, loan, or loan guarantee was made under this title or
which is a qualified health maintenance organization for
purposes of section 1310 (relating to employees' health
benefits plans), from soliciting members through advertising
its services, charges, or other nonprofessional aspects of its
operation. This subsection does not authorize any advertising
which identifies, refers to, or makes any qualitative judgment
concerning, any health professional who provides services for a
health maintenance organization.
(c) The Secretary shall, within 6 months after the date of
the enactment of this subsection, develop a digest of State
laws, regulations, and practices pertaining to development,
establishment, and operation of health maintenance
organizations which shall be updated at least annually and
relevant sections of which shall be provided to the Governor of
each State annually. Such digest shall indicate which State
laws, regulations, and practices appear to be inconsistent with
the operation of this section. The Secretary shall also insure
that appropriate legal consultative assistance is available to
the States for the purpose of complying with the provisions of
this section.
continued regulation of health maintenance organizations
Sec. 1312. [300e-11] (a) If the Secretary determines that
an entity which received a grant, contract, loan, or loan
guarantee under this title as a health maintenance organization
or which was included in a health benefits plan offered to
employees pursuant to section 1310--
(1) fails to provide basic and supplemental
services to its members,
(2) fails to provide such services in the manner
prescribed by section 1301(b), or
(3) is not organized or operated in the manner
prescribed by section 1301(c),
the Secretary may take the action authorized by subsection (b).
(b)(1) If the Secretary makes, with respect to any entity
which provided assurances to the Secretary under section
1310(d)(1), a determination described in subsection (a), the
Secretary shall notify the entity in writing of the
determination. Such notice shall specify the manner in which
the entity has not complied with such assurances and direct
that the entity initiate (within 30 days of the date the notice
is issued by the Secretary or within such longer period as the
Secretary determines is reasonable) such action as may be
necessary to bring (within such period as the Secretary shall
prescribe) the entity into compliance with the assurances. If
the entity fails to initiate corrective action within the
period prescribed by the notice or fails to comply with the
assurances within such period as the Secretary prescribes, then
after the Secretary provides the entity a reasonable
opportunity for reconsideration of his determination,
including, at the entity's election, a fair hearing (A) the
entity shall not be a qualified health maintenance organization
for purposes of section 1310 until such date as the Secretary
determines that it is in compliance with the assurances, and
(B) each employer which has offered membership in the entity in
compliance with section 1310, each lawfully recognized
collective bargaining representative or other employee
representative which represents the employees of each such
employer, and the members of such entity shall be notified by
the entity that the entity is not a qualified health
maintenance organization for purposes of such section. The
notice required by clause (B) of the preceding sentence shall
contain, in readily understandable language, the reasons for
the determination that the entity is not a qualified health
maintenance organization. The Secretary shall publish in the
Federal Register each determination referred to in this
paragraph.
(2) If the Secretary makes, with respect to an entity which
has received a grant, contract, loan, or loan guarantee under
this title, a determination described in subsection (a), the
Secretary may, in addition to any other remedies available to
him, bring a civil action in the United States district court
for the district in which such entity is located to enforce its
compliance with the assurances it furnished respecting the
provision of basic and supplemental health services or its
organization or operation, as the case may be, which assurances
were made in connection with its application under this title
for the grant, contract, loan, or loan guarantee.
limitation on source of funding for health maintenance organizations
Sec. 1313. [300e-12] No funds appropriated under any
provision of this Act (except as provided in sections 329 and
330) other than this title may be used--
(1) for grants or contracts for surveys or other
activities to determine the feasibility of developing
or expanding health maintenance organizations or other
entities which provide, directly or indirectly, health
services to a defined population on a prepaid basis;
(2) for grants or contracts, or for payments under
loan guarantees, for planning projects for the
establishment or expansion of such organizations or
entities;
(3) for grants or contracts, or for payments under
loan guarantees, for projects for the initial
development or expansion of such organizations or
entities; or
(4) for loans, or for payments under loan
guarantees, to assist in meeting the costs of the
initial operation after establishment or expansion of
such organizations or entities or in meeting the costs
of such organizations in acquiring or constructing
ambulatory health care facilities.
annual report
Sec. 1315. [300e-14] (a) The Secretary shall periodically
review the programs of assistance authorized by this title and
make an annual report to the Congress of a summary of the
activities under each program. The Secretary shall include in
such summary--
(1) a summary of each grant, contract, loan, or
loan guarantee made under this title in the period
covered by the report and a list of the health
maintenance organizations which during such period
became qualified health maintenance organizations for
purposes of section 1310;
(2) the statistics and other information reported
in such period to the Secretary in accordance with
section 1301(c)(11);
(3) findings with respect to the ability of the
health maintenance organizations assisted under this
title--
(A) to operate on a fiscally sound basis
without continued Federal financial assistance,
(B) to meet the requirements of section
1301(c) respecting their organization and
operation,
(C) to provide basic and supplemental
health services in the manner prescribed by
section 1301(b),
(D) to include indigent and high-risk
individuals in their membership, and
(E) to provide services to medically
underserved populations; and
(4) findings with respect to--
(A) the operation of distinct categories of
health maintenance organizations in comparison
with each other,
(B) health maintenance organizations as a
group in comparison with alternative forms of
health care delivery, and
(C) the impact that health maintenance
organizations, individually, by category, and
as a group, have on the health of the public.
(b) The Office of Management and Budget may review the
Secretary's report under subsection (a) before its submission
to the Congress, but the Office may not revise the report or
delay its submission, and it may submit to the Congress its
comments (and those of other departments or agencies of the
Government) respecting such report.
training and technical assistance
Sec. 1317. [300e-16] (a)(1) The Secretary shall establish a
National Health Maintenance Organization Intern Program
(hereinafter in this subsection referred to as the ``Program'')
for the purpose of providing training to individuals to become
administrators and medical directors of health maintenance
organizations or to assume other managerial positions with
health maintenance organizations. Under the Program the
Secretary may directly provide internships for such training
and may make grants to or enter into contracts with health
maintenance organizations and other entities to provide such
internships.
(2) No internship may be provided by the Secretary and no
grant may be made or contract entered into by the Secretary for
the provision of internships unless an application therefor has
been submitted to and approved by the Secretary. Such an
application shall be in such form and contain such information,
and be submitted to the Secretary in such manner, as the
Secretary shall prescribe. Section 1306 does not apply to an
application submitted under this section.
(3) Internships under the Program shall provide for such
stipends and allowances (including travel and subsistence
expenses and dependency allowances) for the recipients of the
internships as the Secretary deems necessary. An internship
provided an individual for training at a health maintenance
organization or any other entity shall also provide for
payments to be made to the organization or other entity for the
cost of support services (including the cost of salaries,
supplies, equipment, and related items) provided such
individual by such organization or other entity. The amount of
any such payments to any organization or other entity shall be
determined by the Secretary and shall bear a direct
relationship to the reasonable costs of the organization or
other entity for establishing and maintaining its training
programs.
(4) Payments under grants under the Program may be made in
advance or by way of reimbursement, and at such intervals and
on such conditions, as the Secretary finds necessary.
(b) The Secretary shall provide technical assistance (1) to
entities intending to become a qualified health maintenance
organization within the meaning of section 1310(d), and (2) to
health maintenance organizations. The Secretary may provide
such technical assistance through grants to public and
nonprofit private entities and contracts with public and
private entities.
(c) The authority of the Secretary to enter into contracts
under subsections (a) and (b) shall be effective for any fiscal
year only to such extent or in such amounts as are provided in
advance by appropriation Acts.
financial disclosure
Sec. 1318. [300e-17] (a) Each health maintenance
organization shall, in accordance with regulations of the
Secretary, report to the Secretary financial information which
shall include the following:
(1) Such information as the Secretary may require
demonstrating that the health maintenance organization
has a fiscally sound operation.
(2) A copy of the report, if any, filed with the
Centers for Medicare & Medicaid Services containing the
information required to be reported under section 1124
of the Social Security Act by disclosing entities and
the information required to be supplied under section
1902(a)(38) of such Act.
(3) A description of transactions, as specified by
the Secretary, between the health maintenance
organization and a party in interest. Such transactions
shall include--
(A) any sale or exchange, or leasing of any
property between the health maintenance
organization and a party in interest;
(B) any furnishing for consideration of
goods, services (including management
services), or facilities between the health
maintenance organization and a party in
interest, but not including salaries paid to
employees for services provided in the normal
course of their employment and health services
provided to members by hospitals and other
providers and by staff, medical group (or
groups), individual practice association (or
associations), or any combination thereof; and
(C) any lending of money or other extension
of credit between a health maintenance
organization and a party in interest.
The Secretary may require that information reported respecting
a health maintenance organization which controls, is controlled
by, or is under common control with, another entity be in the
form of a consolidated financial statement for the organization
and such entity.
(b) For the purposes of this section the term ``party in
interest'' means:
(1) any director, officer, partner, or employee
responsible for management or administration of a
health maintenance organization, any person who is
directly or indirectly the beneficial owner of more
than 5 per centum of the equity of the organization,
any person who is the beneficial owner of a mortgage,
deed of trust, note, or other interest secured by, and
valuing more than 5 per centum of the health
maintenance organization, and, in the case of a health
maintenance organization organized as a nonprofit
corporation, an incorporator or member of such
corporation under applicable State corporation law;
(2) any entity in which a person described in
paragraph (1)--
(A) is an officer or director;
(B) is a partner (if such entity is
organized as a partnership);
(C) has directly or indirectly a beneficial
interest of more than 5 per centum of the
equity; or
(D) has a mortgage, deed of trust, note, or
other interest valuing more than 5 per centum
of the assets of such entity;
(3) any person directly or indirectly controlling,
controlled by, or under common control with a health
maintenance organization; and
(4) any spouse, child, or parent of an individual
described in paragraph (1).
(c) Each health maintenance organization shall make the
information reported pursuant to subsection (a) available to
its enrollees upon reasonable request.
(d) The Secretary shall, as he deems necessary, conduct an
evaluation of transactions reported to the Secretary under
subsection (a)(3) for the purpose of determining their adverse
impact, if any, on the fiscal soundness and reasonableness of
charges to the health maintenance organization with respect to
which they transpired. The Secretary shall evaluate the
reported transactions of not less than five, or if there are
more than twenty health maintenance organizations reporting
such transactions, not less than one-fourth of the health
maintenance organizations reporting any such transactions under
subsection (a)(3).
(f) \1\ Nothing in this section shall be construed to
confer upon the Secretary any authority to approve or
disapprove the rates charged by any health maintenance
organization.
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\1\ Subsection (e) was repealed by section 810 of Public Law 99-
660.
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(g) Any health maintenance organization failing to file
with the Secretary the annual financial statement required in
subsection (a) shall be ineligible for any Federal assistance
under this title until such time as such statement is received
by the Secretary and shall not be a qualified health
maintenance organization for purposes of section 1310.
(h) Whoever knowingly and willfully makes or causes to be
made any false statement or representation of a material fact
in any statement filed pursuant to this section shall be guilty
of a felony and upon conviction thereof shall be fined not more
than $25,000 or imprisoned for not more than five years, or
both.
TITLE XIV--SAFETY OF PUBLIC WATER SYSTEMS
[For Text of This Title See Volume 2 of the Environmental Law
Compilation]
TITLE XV--PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND
CERVICAL CANCERS
SEC. 1501. [300K] ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may make
grants to States on the basis of an established competitive
review process for the purpose of carrying out programs--
(1) to screen women for breast and cervical cancer
as a preventive health measure;
(2) to provide appropriate referrals for medical
treatment of women screened pursuant to paragraph (1)
and to ensure, to the extent practicable, the provision
of appropriate follow-up services and support services
such as case management;
(3) to develop and disseminate public information
and education programs for the detection and control of
breast and cervical cancer;
(4) to improve the education, training, and skills
of health professionals (including allied health
professionals) in the detection and control of breast
and cervical cancer;
(5) to establish mechanisms through which the
States can monitor the quality of screening procedures
for breast and cervical cancer, including the
interpretation of such procedures; and
(6) to evaluate activities conducted under
paragraphs (1) through (5) through appropriate
surveillance or program-monitoring activities.
(b) Grant and Contract Authority of States.--
(1) In general.--A State receiving a grant under
subsection (a) may, subject to paragraphs (2) and (3),
expend the grant to carry out the purpose described in
such subsection through grants to public and nonprofit
private entities and through contracts with public and
private entities.
(2) Certain applications.--If a nonprofit private
entity and a private entity that is not a nonprofit
entity both submit applications to a State to receive
an award of a grant or contract pursuant to paragraph
(1), the State may give priority to the application
submitted by the nonprofit private entity in any case
in which the State determines that the quality of such
application is equivalent to the quality of the
application submitted by the other private entity.
(3) Payments for screenings.--The amount paid by a
State to an entity under this subsection for a
screening procedure under subsection (a)(1) may not
exceed the amount that would be paid under part B of
title XVIII of the Social Security Act if payment were
made under such part for furnishing the procedure to a
woman enrolled under such part.
(c) Special Consideration for Certain States.--In making
grants under subsection (a) to States whose initial grants
under such subsection are made for fiscal year 1995 or any
subsequent fiscal year, the Secretary shall give special
consideration to any State whose proposal for carrying out
programs under such subsection--
(1) has been approved through a process of peer
review; and
(2) is made with respect to geographic areas in
which there is--
(A) a substantial rate of mortality from
breast or cervical cancer; or
(B) a substantial incidence of either of
such cancers.
(d) Coordinating Committee Regarding Year 2020 Health
Objectives.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall establish a
committee to coordinate the activities of the agencies of the
Public Health Service (and other appropriate Federal agencies)
that are carried out toward achieving the objectives
established by the Secretary for reductions in the rate of
mortality from breast and cervical cancer in the United States
by the year 2020. Such committee shall be comprised of Federal
officers or employees designated by the heads of the agencies
involved to serve on the committee as representatives of the
agencies, and such representatives from other public or private
entities as the Secretary determines to be appropriate.
SEC. 1502. [300L] REQUIREMENT OF MATCHING FUNDS.
(a) In General.--The Secretary may not make a grant under
section 1501 unless the State involved agrees, with respect to
the costs to be incurred by the State in carrying out the
purpose described in such section, to make available non-
Federal contributions (in cash or in kind under subsection (b))
toward such costs in an amount equal to not less than $1 for
each $3 of Federal funds provided in the grant. Such
contributions may be made directly or through donations from
public or private entities.
(b) Determination of Amount of Non-Federal Contribution.--
(1) In general.--Non-Federal contributions required
in subsection (a) may be in cash or in kind, fairly
evaluated, including equipment or services (and
excluding indirect or overhead costs). Amounts provided
by the Federal Government, or services assisted or
subsidized to any significant extent by the Federal
Government, may not be included in determining the
amount of such non-Federal contributions.
(2) Maintenance of effort.--In making a
determination of the amount of non-Federal
contributions for purposes of subsection (a), the
Secretary may include only non-Federal contributions in
excess of the average amount of non-Federal
contributions made by the State involved toward the
purpose described in section 1501 for the 2-year period
preceding the first fiscal year for which the State is
applying to receive a grant under such section.
(3) Inclusion of relevant non-federal contributions
for medicaid.--In making a determination of the amount
of non-Federal contributions for purposes of subsection
(a), the Secretary shall, subject to paragraphs (1) and
(2) of this subsection, include any non-Federal amounts
expended pursuant to title XIX of the Social Security
Act by the State involved toward the purpose described
in paragraphs (1) and (2) of section 1501(a).
SEC. 1502A. [300L-1] REQUIREMENT REGARDING MEDICAID.
The Secretary may not make a grant under section 1501 for a
program in a State unless the State plan under title XIX of the
Social Security Act for the State includes the screening
procedures specified in subparagraphs (A) and (B) of section
1503(a)(2) as medical assistance provided under the plan.
SEC. 1503. [300M] REQUIREMENTS WITH RESPECT TO TYPE AND QUALITY OF
SERVICES.
(a) Requirement of Provision of All Services by Date
Certain.--The Secretary may not make a grant under section 1501
unless the State involved agrees--
(1) to ensure that, initially and throughout the
period during which amounts are received pursuant to
the grant, not less than 60 percent of the grant is
expended to provide each of the services or activities
described in paragraphs (1) and (2) of section 1501(a),
including making available screening procedures for
both breast and cervical cancers;
(2) subject to subsection (b), to ensure that--
(A) in the case of breast cancer, both a
physical examination of the breasts and the
screening procedure known as a mammography are
conducted; and
(B) in the case of cervical cancer, both a
pelvic examination and the screening procedure
known as a pap smear are conducted;
(3) to ensure that, by the end of any second fiscal
year of payments pursuant to the grant, each of the
services or activities described in section 1501(a) is
provided; and
(4) to ensure that not more than 40 percent of the
grant is expended to provide the services or activities
described in paragraphs (3) through (6) of such
section.
(b) Use of Improved Screening Procedures.--The Secretary
may not make a grant under section 1501 unless the State
involved agrees that, if any screening procedure superior to a
procedure described in subsection (a)(2) becomes commonly
available and is recommended for use, any entity providing
screening procedures pursuant to the grant will utilize the
superior procedure rather than the procedure described in such
subsection.
(c) \1\ Quality Assurance Regarding Screening Procedures.--
The Secretary may not make a grant under section 1501 unless
the State involved agrees that the State will, in accordance
with applicable law, assure the quality of screening procedures
conducted pursuant to such section.
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\1\ Section 101(c)(2) of Public Law 103-183 (107 Stat. 2228)
provides as follows:
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``(2) Transition rule regarding mammographies.--With respect
to the screening procedure for breast cancer known as a
mammography, the requirements in effect on the day before the
date of the enactment of this Act under section 1503(c) of the
Public Health Service Act remain in effect (for an individual
or facility conducting such procedures pursuant to a grant to a
State under section 1501 of such Act) until there is in effect
for the facility a certificate (or provisional certificate)
issued under section 354 of such Act.''.
(d) Waiver of Services Requirement on Division of Funds.--
(1) In general.--The Secretary shall establish a
demonstration project under which the Secretary may
waive the requirements of paragraphs (1) and (4) of
subsection (a) for not more than 5 States, if--
(A) the State involved will use the waiver
to leverage non-Federal funds to supplement
each of the services or activities described in
paragraphs (1) and (2) of section 1501(a);
(B) the application of such requirement
would result in a barrier to the enrollment of
qualifying women;
(C) the State involved--
(i) demonstrates, to the
satisfaction of the Secretary, the
manner in which the State will use such
waiver to expand the level of screening
and follow-up services provided
immediately prior to the date on which
the waiver is granted; and
(ii) provides assurances,
satisfactory to the Secretary, that the
State will, on an annual basis,
demonstrate, through such documentation
as the Secretary may require, that the
State has used such waiver as described
in clause (i);
(D) the State involved submits to the
Secretary--
(i) assurances, satisfactory to the
Secretary, that the State will maintain
the average annual level of State
fiscal year expenditures for the
services and activities described in
paragraphs (1) and (2) of section
1501(a) for the period for which the
waiver is granted, and for the period
for which any extension of such wavier
is granted, at a level that is not less
than--
(I) the level of the State
fiscal year expenditures for
such services and activities
for the fiscal year preceding
the first fiscal year for which
the waiver is granted; or
(II) at the option of the
State and upon approval by the
Secretary, the average level of
the State expenditures for such
services and activities for the
3-fiscal year period preceding
the first fiscal year for which
the waiver is granted; and
(ii) a plan, satisfactory to the
Secretary, for maintaining the level of
activities carried out under the waiver
after the expiration of the waiver and
any extension of such waiver;
(E) the Secretary finds that granting such
a waiver to a State will increase the number of
women in the State that receive each of the
services or activities described in paragraphs
(1) and (2) of section 1501(a), including
making available screening procedures for both
breast and cervical cancers; and
(F) the Secretary finds that granting such
a waiver to a State will not adversely affect
the quality of each of the services or
activities described in paragraphs (1) and (2)
of section 1501(a).
(2) Duration of waiver.--
(A) In general.--In granting waivers under
paragraph (1), the Secretary--
(i) shall grant such waivers for a
period that is not less than 1 year but
not more than 2 years; and
(ii) upon request of a State, may
extend a waiver for an additional
period that is not less than 1 year but
not more than 2 years in accordance
with subparagraph (B).
(B) Additional period.--The Secretary, upon
the request of a State that has received a
waiver under paragraph (1), shall, at the end
of the waiver period described in subparagraph
(A)(i), review performance under the waiver and
may extend the waiver for an additional period
if the Secretary determines that--
(i) without an extension of the
waiver, there will be a barrier to the
enrollment of qualifying women;
(ii) the State requesting such
extended waiver will use the waiver to
leverage non-Federal funds to
supplement the services or activities
described in paragraphs (1) and (2) of
section 1501(a);
(iii) the waiver has increased, and
will continue to increase, the number
of women in the State that receive the
services or activities described in
paragraphs (1) and (2) of section
1501(a);
(iv) the waiver has not, and will
not, result in lower quality in the
State of the services or activities
described in paragraphs (1) and (2) of
section 1501(a); and
(v) the State has maintained the
average annual level of State fiscal
expenditures for the services and
activities described in paragraphs (1)
and (2) of section 1501(a) for the
period for which the waiver was granted
at a level that is not less than--
(I) the level of the State
fiscal year expenditures for
such services and activities
for the fiscal year preceding
the first fiscal year for which
the waiver is granted; or
(II) at the option of the
State and upon approval by the
Secretary, the average level of
the State expenditures for such
services and activities for the
3-fiscal year period preceding
the first fiscal year for which
the waiver is granted.
(3) Reporting requirements.--The Secretary shall
include as part of the evaluations and reports required
under section 1508, the following:
(A) A description of the total amount of
dollars leveraged annually from Non-Federal
entities in States receiving a waiver under
paragraph (1) and how these amounts were used.
(B) With respect to States receiving a
waiver under paragraph (1), a description of
the percentage of the grant that is expended on
providing each of the services or activities
described in--
(i) paragraphs (1) and (2) of
section 1501(a); and
(ii) paragraphs (3) through (6) of
section 1501(a).
(C) A description of the number of States
receiving waivers under paragraph (1) annually.
(D) With respect to States receiving a
waiver under paragraph (1), a description of--
(i) the number of women receiving
services under paragraphs (1), (2), and
(3) of section 1501(a) in programs
before and after the granting of such
waiver; and
(ii) the average annual level of
State fiscal expenditures for the
services and activities described in
paragraphs (1) and (2) of section
1501(a) for the year preceding the
first year for which the waiver was
granted.
(4) Limitation.--Amounts to which a waiver applies
under this subsection shall not be used to increase the
number of salaried employees.
(5) Definitions.--In this subsection:
(A) Indian tribe.--The term ``Indian
tribe'' has the meaning given the term in
section 4 of the Indian Health Care Improvement
Act (25 U.S.C. 1603).
(B) Tribal organization.--The term ``tribal
organization'' has the meaning given the term
in section 4 of the Indian Health Care
Improvement Act.
(C) State.--The term ``State'' means each
of the several States of the United States, the
District of Columbia, the Commonwealth of
Puerto Rico, American Samoa, the Commonwealth
of the Northern Mariana Islands, the Republic
of the Marshall Islands, the Federated States
of Micronesia, the Republic of Palau, an Indian
tribe, and a tribal organization.
(6) Sunset.--The Secretary may not grant a waiver
or extension under this subsection after September 30,
2012.
SEC. 1504. [300N] ADDITIONAL REQUIRED AGREEMENTS.
(a) Priority for Low-Income Women.--The Secretary may not
make a grant under section 1501 unless the State involved
agrees that low-income women will be given priority in the
provision of services and activities pursuant to paragraphs (1)
and (2) of section 1501(a).
(b) Limitation on Imposition of Fees for Services.--The
Secretary may not make a grant under section 1501 unless the
State involved agrees that, if a charge is imposed for the
provision of services or activities under the grant, such
charge--
(1) will be made according to a schedule of charges
that is made available to the public;
(2) will be adjusted to reflect the income of the
woman involved; and
(3) will not be imposed on any woman with an income
of less than 100 percent of the official poverty line,
as established by the Director of the Office of
Management and Budget and revised by the Secretary in
accordance with section 673(2) of the Omnibus Budget
Reconciliation Act of 1981.
(c) Statewide Provision of Services.--
(1) In general.--The Secretary may not make a grant
under section 1501 unless the State involved agrees
that services and activities under the grant will be
made available throughout the State, including
availability to members of any Indian tribe or tribal
organization (as such terms are defined in section 4 of
the Indian Self-Determination and Education Assistance
Act).
(2) Waiver.--The Secretary may waive the
requirement established in paragraph (1) for a State if
the Secretary determines that compliance by the State
with the requirement would result in an inefficient
allocation of resources with respect to carrying out
the purpose described in section 1501(a).
(3) Grants to tribes and tribal organizations.--
(A) The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may make grants to tribes and
tribal organizations (as such terms are used in
paragraph (1)) for the purpose of carrying out
programs described in section 1501(a). This
title applies to such a grant (in relation to
the jurisdiction of the tribe or organization)
to the same extent and in the same manner as
such title applies to a grant to a State under
section 1501 (in relation to the jurisdiction
of the State).
(B) If a tribe or tribal organization is
receiving a grant under subparagraph (A) and
the State in which the tribe or organization is
located is receiving a grant under section
1501, the requirement established in paragraph
(1) for the State regarding the tribe or
organization is deemed to have been waived
under paragraph (2).
(d) Relationship to Items and Services Under Other
Programs.--The Secretary may not make a grant under section
1501 unless the State involved agrees that the grant will not
be expended to make payment for any item or service to the
extent that payment has been made, or can reasonably be
expected to be made, with respect to such item or service--
(1) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(2) by an entity that provides health services on a
prepaid basis.
(e) Coordination With Other Breast and Cervical Cancer
Programs.--The Secretary may not make a grant under section
1501 unless the State involved agrees that the services and
activities funded through the grant shall be coordinated with
other Federal, State, and local breast and cervical cancer
programs.
(f) Limitation on Administrative Expenses.--The Secretary
may not make a grant under section 1501 unless the State
involved agrees that not more than 10 percent of the grant will
be expended for administrative expenses with respect to the
grant.
(g) Restrictions on Use of Grant.--The Secretary may not
make a grant under section 1501 unless the State involved
agrees that the grant will not be expended to provide inpatient
hospital services for any individual.
(h) Records and Audits.--The Secretary may not make a grant
under section 1501 unless the State involved agrees that--
(1) the State will establish such fiscal control
and fund accounting procedures as may be necessary to
ensure the proper disbursal of, and accounting for,
amounts received by the State under such section; and
(2) upon request, the State will provide records
maintained pursuant to paragraph (1) to the Secretary
or the Comptroller of the United States for purposes of
auditing the expenditures by the State of the grant.
(i) Reports to Secretary.--The Secretary may not make a
grant under section 1501 unless the State involved agrees to
submit to the Secretary such reports as the Secretary may
require with respect to the grant.
SEC. 1505. [300N-1] DESCRIPTION OF INTENDED USES OF GRANT.
The Secretary may not make a grant under section 1501
unless--
(1) the State involved submits to the Secretary a
description of the purposes for which the State intends
to expend the grant;
(2) the description identifies the populations,
areas, and localities in the State with a need for the
services or activities described in section 1501(a);
(3) the description provides information relating
to the services and activities to be provided,
including a description of the manner in which the
services and activities will be coordinated with any
similar services or activities of public and private
entities; and
(4) the description provides assurances that the
grant funds will be used in the most cost-effective
manner.
SEC. 1506. [300N-2] REQUIREMENT OF SUBMISSION OF APPLICATION.
The Secretary may not make a grant under section 1501
unless an application for the grant is submitted to the
Secretary, the application contains the description of intended
uses required in section 1505, and the application is in such
form, is made in such manner, and contains such agreements,
assurances, and information as the Secretary determines to be
necessary to carry out this title.
SEC. 1507. [300N-3] TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND
SERVICES IN LIEU OF GRANT FUNDS.
(a) Technical Assistance.--The Secretary may provide
training and technical assistance with respect to the planning,
development, and operation of any program or service carried
out pursuant to section 1501. The Secretary may provide such
technical assistance directly or through grants to, or
contracts with, public and private entities.
(b) Provision of Supplies and Services in Lieu of Grant
Funds.--
(1) In general.--Upon the request of a State
receiving a grant under section 1501, the Secretary
may, subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding the
State in carrying out such section and, for such
purpose, may detail to the State any officer or
employee of the Department of Health and Human
Services.
(2) Corresponding reduction in payments.--With
respect to a request described in paragraph (1), the
Secretary shall reduce the amount of payments under the
grant under section 1501 to the State involved by an
amount equal to the costs of detailing personnel
(including pay, allowances, and travel expenses) and
the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary
shall, for the payment of expenses incurred in
complying with such request, expend the amounts
withheld.
SEC. 1508. [300N-4] EVALUATIONS AND REPORTS.
(a) Evaluations.--The Secretary shall, directly or through
contracts with public or private entities, provide for annual
evaluations of programs carried out pursuant to section 1501.
Such evaluations shall include evaluations of--
(1) the extent to which States carrying out such
programs are in compliance with section 1501(a)(2) and
with section 1504(c); and
(2) the extent to which each State receiving a
grant under this title is in compliance with section
1502, including identification of--
(A) the amount of the non-Federal
contributions by the State for the preceding
fiscal year, disaggregated according to the
source of the contributions; and
(B) the proportion of such amount of non-
Federal contributions relative to the amount of
Federal funds provided through the grant to the
State for the preceding fiscal year.
(b) Report to Congress.--The Secretary shall, not later
than 1 year after the date of the enactment of the National
Breast and Cervical Cancer Early Detection Program
Reauthorization of 2007, and annually thereafter, submit to the
Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human
Resources of the Senate, a report summarizing evaluations
carried out pursuant to subsection (a) during the preceding
fiscal year and making such recommendations for administrative
and legislative initiatives with respect to this title as the
Secretary determines to be appropriate, including
recommendations regarding compliance by the States with section
1501(a)(2) and with section 1504(c).
SEC. 1509. [300N-4A] SUPPLEMENTAL GRANTS FOR ADDITIONAL PREVENTIVE
HEALTH SERVICES.
(a) Demonstration Projects.--In the case of States
receiving grants under section 1501, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, may make grants to not more than 3 such States to
carry out demonstration projects for the purpose of--
(1) providing preventive health services in
addition to the services authorized in such section,
including screenings regarding blood pressure and
cholesterol, and including health education;
(2) providing appropriate referrals for medical
treatment of women receiving services pursuant to
paragraph (1) and ensuring, to the extent practicable,
the provision of appropriate follow-up services; and
(3) evaluating activities conducted under
paragraphs (1) and (2) through appropriate surveillance
or program-monitoring activities.
(b) Status as Participant in Program Regarding Breast and
Cervical Cancer.--The Secretary may not make a grant under
subsection (a) unless the State involved agrees that services
under the grant will be provided only through entities that are
screening women for breast or cervical cancer pursuant to a
grant under section 1501.
(c) Applicability of Provisions of General Program.--This
title applies to a grant under subsection (a) to the same
extent and in the same manner as such title applies to a grant
under section 1501.
(d) Funding.--
(1) In general.--Subject to paragraph (2), for the
purpose of carrying out this section, there are
authorized to be appropriated $3,000,000 for fiscal
year 1994, and such sums as may be necessary for each
of the fiscal years 1995 through 2003.
(2) Limitation regarding funding with respect to
breast and cervical cancer.--The authorization of
appropriations established in paragraph (1) is not
effective for a fiscal year unless the amount
appropriated under section 1510(a) for the fiscal year
is equal to or greater than $100,000,000.
SEC. 1510. [300N-5] FUNDING FOR GENERAL PROGRAM.
(a) Authorization of Appropriations.--For the purpose of
carrying out this title, there are authorized to be
appropriated $50,000,000 for fiscal year 1991, such sums as may
be necessary for each of the fiscal years 1992 and 1993,
$150,000,000 for fiscal year 1994, such sums as may be
necessary for each of the fiscal years 1995 through 2003,
$225,000,000 for fiscal year 2008, $245,000,000 for fiscal year
2009, $250,000,000 for fiscal year 2010, $255,000,000 for
fiscal year 2011, and $275,000,000 for fiscal year 2012.
(b) Set-Aside for Technical Assistance and Provision of
Supplies and Services.--Of the amounts appropriated under
subsection (a) for a fiscal year, the Secretary shall reserve
not more than 20 percent for carrying out section 1507.
TITLE XVI--HEALTH RESOURCES DEVELOPMENT
Part A--Loans and Loan Guarantees
authority for loans and loan guarantees
Sec. 1601. [300q] (a)(1) The Secretary, during the period
ending September 30, 1982, may, in accordance with this part,
make loans from the fund established under section 1602(d) to
any public or nonprofit private entity for projects for--
(A) the discontinuance of unneeded hospital
services or facilities;
(B) the conversion of unneeded hospital services
and facilities to needed health services and medical
facilities, including outpatient medical facilities and
facilities for long-term care;
(C) the renovation and modernization of medical
facilities, particularly projects for the prevention or
elimination of safety hazards, projects to avoid
noncompliance with licensure or accreditation
standards, or projects to replace obsolete facilities;
(D) the construction of new outpatient medical
facilities; and
(E) the construction of new inpatient medical
facilities in areas which have experienced (as
determined by the Secretary) recent rapid population
growth.
(2)(A) The Secretary, during the period ending September
30, 1982, may, in accordance with this part, guarantee to--
(i) non-Federal lenders for their loans to public
and nonprofit private entities for medical facilities
projects described in paragraph (1), and
(ii) the Federal Financing Bank for its loans to
public and nonprofit private entities for such
projects,
payment of principal and interest on such loans.
(B) In the case of a guarantee of any loan to a public or
nonprofit private entity under subparagraph (A)(i) which is
located in an urban or rural poverty area, the Secretary may
pay, to the holder of such loan and for and on behalf of the
project for which the loan was made, amounts sufficient to
reduce by not more than one-half the net effective interest
rate otherwise payable on such loan if the Secretary finds that
without such assistance the project could not be undertaken.
(b) The principal amount of a loan directly made or
guaranteed under subsection (a) for a medical facilities
project, when added to any other assistance provided such
project under part B, may not exceed 90 per centum of the cost
of such project unless the project is located in an area
determined by the Secretary to be an urban or rural poverty
area, in which case the principal amount, when added to other
assistance under part B, may cover up to 100 per centum of such
costs.
(c) The cumulative total of the principal of the loans
outstanding at any time with respect to which guarantees have
been issued, or which have been directly made, may not exceed
such limitations as may be specified in appropriation Acts.
(d) The Secretary, with the consent of the Secretary of
Housing and Urban Development, shall obtain from the Department
of Housing and Urban Development such assistance with respect
to the administration of this part as will promote efficiency
and economy thereof.
general provisions relating to loan guarantees and loans
Sec. 1602. [300q-2] (a)(1) The Secretary may not approve a
loan guarantee for a project under this part unless he
determines that (A) the terms, conditions, security (if any),
and schedule and amount of repayments with respect to the loan
are sufficient to protect the financial interests of the United
States and are otherwise reasonable, including a determination
that the rate of interest does not exceed such per centum per
annum on the principal obligation outstanding as the Secretary
determines to be reasonable, taking into account the range of
interest rates prevailing in the private market for similar
loans and the risks assumed by the United States, and (B) the
loan would not be available on reasonable terms and conditions
without the guarantee under this part.
(2)(A) The United States shall be entitled to recover from
the applicant for a loan guarantee under this part the amount
of any payment made pursuant to such guarantee, unless the
Secretary for good cause waives such right of recovery; and,
upon making any such payment, the United States shall be
subrogated to all of the rights of the recipient of the
payments with respect to which the guarantee was made.
(B) To the extent permitted by subparagraph (C), any terms
and conditions applicable to a loan guarantee under this part
(including terms and conditions imposed under subparagraph (D))
may be modified by the Secretary to the extent he determines it
to be consistent with the financial interest of the United
States.
(C) Any loan guarantee made by the Secretary under this
part shall be incontestable (i) in the hands of an applicant on
whose behalf such guarantee is made unless the applicant
engaged in fraud or misrepresentation in securing such
guarantee, and (ii) as to any person (or his successor in
interest) who makes or contracts to make a loan to such
applicant in reliance thereon unless such person (or his
successor in interest) engaged in fraud or misrepresentation in
making or contracting to make such loan.
(D) Guarantees of loans under this part shall be subject to
such further terms and conditions as the Secretary determines
to be necessary to assure that the purposes of this title will
be achieved.
(b)(1) The Secretary may not approve a loan under this part
unless--
(A) the Secretary is reasonably satisfied that the
applicant under the project for which the loan would be
made will be able to make payments of principal and
interest thereon when due, and
(B) the applicant provides the Secretary with
reasonable assurances that there will be available to
it such additional funds as may be necessary to
complete the project or undertaking with respect to
which such loan is requested.
(2) Any loan made under this part shall (A) have such
security, (B) have such maturity date, (C) be repayable in such
installments, (D) bear interest at a rate comparable to the
current rate of interest prevailing, on the date the loan is
made, with respect to loans guaranteed under this part, minus
any interest subsidy made in accordance with section
1601(a)(2)(B) with respect to a loan made for a project located
in an urban or rural poverty area, and (E) be subject to such
other terms and conditions (including provisions for recovery
in case of default), as the Secretary determines to be
necessary to carry out the purposes of this title while
adequately protecting the financial interests of the United
States.
(3) The Secretary may, for good cause but with due regard
to the financial interests of the United States, waive any
right of recovery which he has by reasons of the failure of a
borrower to make payments of principal of and interest on a
loan made under this part, except that if such loan is sold and
guaranteed, any such waiver shall have no effect upon the
Secretary's guarantee of timely payment of principal and
interest.
(c)(1) The Secretary shall from time to time, but with due
regard to the financial interests of the United States, sell
loans made under this part either on the private market or to
the Federal National Mortgage Association in accordance with
section 302 of the Federal National Mortgage Association
Charter Act or to the Federal Financing Bank.
(2) Any loan so sold shall be sold for an amount which is
equal (or approximately equal) to the amount of the unpaid
principal of such loans as of time of sale.
(3)(A) The Secretary is authorized to enter into an
agreement with the purchaser of any loan sold under this part
under which the Secretary agrees--
(i) to guarantee to such purchaser (and any
successor in interest to such purchaser) payments of
the principal and interest payable under such loan, and
(ii) to pay as an interest subsidy to such
purchaser (and any successor in interest of such
purchaser) amounts which, when added to the amount of
interest payable on such loan, are equivalent to a
reasonable rate of interest on such loan as determined
by the Secretary after taking into account the range of
prevailing interest rates in the private market on
similar loans and the risks assumed by the United
States.
(B) Any agreement under subparagraph (A)--
(i) may provide that the Secretary shall act as
agent of any such purchaser, for the purpose of
collecting from the entity to which such loan was made
and paying over to such purchaser any payments of
principal and interest payable by such entity under
such loan;
(ii) may provide for the repurchase by the
Secretary of any such loan on such terms and conditions
as may be specified in the agreement;
(iii) shall provide that, in the event of any
default by the entity to which such loan was made in
payment of principal or interest due on such loan, the
Secretary shall, upon notification to the purchaser (or
to the successor in interest of such purchaser), have
the option to close out such loan (and any obligations
of the Secretary with respect thereto) by paying to the
purchaser (or his successor in interest) the total
amount of outstanding principal and interest due
thereon at the time of such notification; and
(iv) shall provide that, in the event such loan is
closed out as provided in clause (iii), or in the event
of any other loss incurred by the Secretary by reason
of the failure of such entity to make payments of
principal or interest on such loan, the Secretary shall
be subrogated to all rights of such purchaser for
recovery of such loss from such entity.
(4) Amounts received by the Secretary as proceeds from the
sale of loans under this subsection shall be deposited in the
fund established under subsection (d).
(5) If any loan to a public entity under this part is sold
and guaranteed by the Secretary under this subsection, interest
paid on such loan after its sale and any interest subsidy paid,
under paragraph (3)(A)(ii), by the Secretary with respect to
such loan which is received by the purchaser of the loan (or
the purchaser's successor in interest) shall be included in the
gross income of the purchaser or successor for the purpose of
chapter 1 of the Internal Revenue Code of 1954.
(d)(1) There is established in the Treasury a loan and loan
guarantee fund (hereinafter in this subsection referred to as
the ``fund'') which shall be available to the Secretary without
fiscal year limitation, in such amounts as may be specified
from time to time in appropriation Acts--
(A) to enable him to make loans under this part,
(B) to enable him to discharge his responsibilities
under loan guarantees issued by him under this part,
(C) for payment of interest under section
1601(a)(2)(B) on loans guaranteed under this part,
(D) for repurchase of loans under subsection
(c)(3)(B),
(E) for payment of interest on loans which are sold
and guaranteed, and
(F) to enable the Secretary to take the action
authorized by subsection (f).
There are authorized to be appropriated from time to time such
amounts as may be necessary to provide the sums required for
the fund. There shall also be deposited in the fund amounts
received by the Secretary in connection with loans and loan
guarantees under this part and other property or assets derived
by him from his operations respecting such loans and loan
guarantees, including any money derived from the sale of
assets.
(2) If at any time the sums in the funds are insufficient
to enable the Secretary--
(A) to make payments of interest under section
1601(a)(2)(B),
(B) to otherwise comply with guarantees under this
part of loans to nonprofit private entities,
(C) in the case of a loan which was made, sold, and
guaranteed under this part, to make to the purchaser of
such loan payments of principal and interest on such
loan after default by the entity to which the loan was
made, or
(D) to repurchase loans under subsection (c)(3)(B),
(E) to make payments of interest on loans which are
sold and guaranteed, and
(F) to enable the Secretary to take the action
authorized by subsection (f),
he is authorized to issue to the Secretary of the Treasury
notes or other obligations in such forms and denominations
bearing such maturities, and subject to such terms and
conditions, as may be prescribed by the Secretary with the
approval of the Secretary of the Treasury. Such notes or other
obligations shall bear interest at a rate determined by the
Secretary of the Treasury, taking into consideration the
current average market yield on outstanding marketable
obligations of the United States of comparable maturities
during the month preceding the issuance of the notes or other
obligations. The Secretary of the Treasury shall purchase any
notes and other obligations issued under this paragraph and for
that purpose he may use as a public debt transaction the
proceeds from the sale of any securities issued under the
Second Liberty Bond Act, and the purposes for which the
securities may be issued under that Act are extended to include
any purchase of such notes and obligations. The Secretary of
the Treasury may at any time sell any of the notes or other
obligations acquired by him under this paragraph. All
redemptions, purchases, and sales by the Secretary of the
Treasury of such notes or other obligations shall be treated as
public debt transactions of the United States. Sums borrowed
under this paragraph shall be deposited in the fund and
redemption of such notes and obligations shall be made by the
Secretary from the fund.
(e)(1) The assets, commitments, obligations, and
outstanding balances of the loan guarantee and loan fund
established in the Treasury by section 626 shall be transferred
to the fund established by subsection (d) of this section.
(2) To provide additional capitalization for the fund
established under subsection (d) there are authorized to be
appropriated to the fund, such sums as may be necessary for the
fiscal years ending June 30, 1975, June 30, 1976, September 30,
1977, September 30, 1978, September 30, 1979, September 30,
1980, September 30, 1981, and September 30, 1982.
(f)(1) The Secretary may take such action as may be
necessary to prevent a default on a loan made or guaranteed
under this part or under title VI, including the waiver of
regulatory conditions, deferral of loan payments, renegotiation
of loans, and the expenditure of funds for technical and
consultative assistance, for the temporary payment of the
interest and principal on such a loan, and for other purposes.
Any such expenditure made under the preceding sentence on
behalf of a medical facility shall be made under such terms and
conditions as the Secretary shall prescribe, including the
implementation of such organizational, operational, and
financial reforms as the Secretary determines are appropriate
and the disclosure of such financial or other information as
the Secretary may require to determine the extent of the
implementation of such reforms.
(2) The Secretary may take such action, consistent with
State law respecting foreclosure procedures, as he deems
appropriate to protect the interest of the United States in the
event of a default on a loan made or guaranteed under this part
or under title VI, including selling real property pledged as
security for such a loan or loan guarantee and for a reasonable
period of time taking possession of, holding, and using real
property pledged as security for such a loan or loan guarantee.
Part B--Project Grants
project grants
Sec. 1610. [300r] (a)(1)(A) The Secretary may make grants
for construction or modernization projects designed to--
(i) eliminate or prevent in medical facilities
imminent safety hazards as defined by Federal, State,
or local fire, building, or life safety codes or
regulations, or
(ii) avoid noncompliance by medical facilities with
State or voluntary licensure or accreditation
standards.
(B) A grant under subparagraph (A) may only be made to--
(i) a State or political subdivision of a State,
including any city, town, county, borough, hospital
district authority, or public or quasi-public
corporation, for any medical facility owned or operated
by the State or political subdivision; and
(ii) a nonprofit private entity for any medical
facility owned or operated by the entity but only if
the Secretary determines--
(I) the level of community service provided
by the facility and the proportion of its
patients who are unable to pay for services
rendered in the facility is similar to such
level and proportion in a medical facility of a
State or political subdivision, and
(II) that without a grant under
subparagraph (A) there would be a disruption of
the provision of health care to low-income
individuals.
(2) The amount of any grant under paragraph (1) may not
exceed 75 per centum of the cost of the project for which the
grant is made unless the project is located in an area
determined by the Secretary to be an urban or rural poverty
area, in which case the grant may cover up to 100 per centum of
such costs.
(3) There are authorized to be appropriated for grants
under paragraph (1) $40,000,000 for the fiscal year ending
September 30, 1980, $50,000,000 for the fiscal year ending
September 30, 1981, and $50,000,000 for the fiscal year ending
September 30, 1982. Funds available for obligation under this
subsection (as in effect before the date of the enactment of
the Health Planning and Resources Development Amendments of
1979) in the fiscal year ending September 30, 1979, shall
remain available for obligation under this subsection in the
succeeding fiscal year.
(b)(1) The Secretary may make grants to public and
nonprofit private entities for projects for (A) construction or
modernization of outpatient medical facilities which are
located apart from hospitals and which will provide services
for medically underserved populations, and (B) conversion of
existing facilities into outpatient medical facilities or
facilities for long-term care to provide services for such
populations.
(2) The amount of any grant under paragraph (1) may not
exceed 80 per centum of the cost of the project for which the
grant is made unless the project is located in an area
determined by the Secretary to be an urban or rural poverty
area, in which case the grant may cover up to 100 per centum of
such costs.
(3) There are authorized to be appropriated for grants
under paragraph (1) $15,000,000 for the fiscal year ending
September 30, 1981, and $15,000,000 for the fiscal year ending
September 30, 1982.
Part C--General Provisions
general regulations
Sec. 1620. [300s] The Secretary shall by regulation--
(1) prescribe the manner in which he shall
determine the priority among projects for which
assistance is available under part A or B, based on the
relative need of different areas for such projects and
giving special consideration--
(A) to projects for medical facilities
serving areas with relatively small financial
resources and for medical facilities serving
rural communities,
(B) in the case of projects for
modernization of medical facilities, to
projects for facilities serving densely
populated areas,
(C) in the case of projects for
construction of outpatient medical facilities,
to projects that will be located in, and
provide services for residents of, areas
determined by the Secretary to be rural or
urban poverty areas,
(D) to projects designed to (i) eliminate
or prevent imminent safety hazards as defined
by Federal, State, or local fire, building, or
life safety codes or regulations, or (ii) avoid
noncompliance with State or voluntary licensure
or accreditation standards, and
(E) to projects for medical facilities
which, alone or in conjunction with other
facilities, will provide comprehensive health
care, including outpatient and preventive care
as well as hospitalization;
(2) prescribe for medical facilities projects
assisted under part A or B general standards of
construction, modernization, and equipment, which
standards may vary on the basis of the class of
facilities and their location; and
(3) prescribe the general manner in which easy
entity which receives financial assistance under part A
or B or has received financial assistance under part A
or B or title VI shall be required to comply with the
assurances required to be made at the time such
assistance was received and the means by which such
entity shall be required to demonstrate compliance with
such assurances.
An entity subject to the requirements prescribed pursuant to
paragraph (3) respecting compliance with assurances made in
connection with receipt of financial assistance shall submit
periodically to the Secretary data and information which
reasonably supports the entity's compliance with such
assurances. The Secretary may not waive the requirement of the
preceding sentence.
applications
Sec. 1621. [300s-1] (a) No loan, loan guarantee, or grant
may be made under part A or B for a medical facilities project
unless an application for such project has been submitted to
and approved by the Secretary. If two or more entities join in
a project, an application for such project may be filed by any
of such entities or by all of them.
(b)(1) An application for a medical facilities project
shall be submitted in such form and manner as the Secretary
shall by regulation prescribe and shall, except as provided in
paragraph (2), set forth--
(A) in the case of a modernization project for a
medical facility for continuation of existing health
services, a finding by the State Agency of a continued
need for such services, and, in the case of any other
project for a medical facility, a finding by the State
Agency of the need for the new health services to be
provided through the medical facility upon completion
of the project;
(B) in the case of an application for a grant,
assurances satisfactory to the Secretary that (i) the
applicant making the application would not be able to
complete the project for which the application is
submitted without the grant applied for, and (ii) in
the case of a project to construct a new medical
facility, it would be inappropriate to convert an
existing medical facility to provide the services to be
provided through the new medical facility;
(C) in the case of a project for the discontinuance
of a service or facility or the conversion of a service
or a facility, an evaluation of the impact of such
discontinuance or conversion on the provision of health
care in the health service area in which such service
was provided or facility located;
(D) a description of the site of such project;
(E) plans and specifications therefor which meet
the requirements of the regulations prescribed under
section 1620(2);
(F) reasonable assurance that title to such site is
or will be vested in one or more of the entities filing
the application or in a public or other nonprofit
entity which is to operate the facility on completion
of the project;
(G) reasonable assurance that adequate financial
support will be available for the completion of the
project and for its maintenance and operation when
completed, and, for the purpose of determining if the
requirements of this subparagraph are met, Federal
assistance provided directly to a medical facility
which is located in an area determined by the Secretary
to be an urban or rural poverty area or through
benefits provided individuals served at such facility
shall be considered as financial support;
(H) the type of assistance being sought under part
A or B for the project;
(I) reasonable assurance that all laborers and
mechanics employed by contractors or subcontractors in
the performance of work on a project will be paid wages
at rates not less than those prevailing on similar
construction in the locality as determined by the
Secretary of Labor in accordance with the Act of March
3, 1931 (40 U.S.C. 276a--276a-5, known as the Davis-
Bacon Act), and the Secretary of Labor shall have with
respect to such labor standards the authority and
functions set forth in Reorganization Plan Numbered 14
of 1950 (15 FR 3176; 5 U.S.C. Appendix) and section 2
of the Act of June 13, 1934 (40 U.S.C. 276c);
(J) in the case of a project for the construction
or modernization of an outpatient facility, reasonable
assurance that the services of a general hospital will
be available to patients at such facility who are in
need of hospital care; and
(K) reasonable assurance that at all times after
such application is approved (i) the facility or
portion thereof to be constructed, modernized, or
converted will be made available to all persons
residing or employed in the area served by the
facility, and (ii) there will be made available in the
facility or portion thereof to be constructed,
modernized, or converted a reasonable volume of
services to persons unable to pay therefor and the
Secretary, in determining the reasonableness of the
volume of services provided, shall take into
consideration the extent to which compliance is
feasible from a financial viewpoint.
(2)(A) The Secretary may waive--
(i) the requirements of subparagraph (D) of
paragraph (1) for compliance with modernization and
equipment standards prescribed pursuant to section
1620(2), and
(ii) the requirement of subparagraph (E) of
paragraph (1) respecting title to a project site,
in the case of an application for a project described in
subparagraph (B) of this paragraph.
(B) A project referred to in subparagraph (A) is a
project--
(i) for the modernization of an outpatient medical
facility which will provide general purpose health
services, which is not part of a hospital, and which
will serve a medically underserved population as
defined in section 1624 or as designated by a health
systems agency, and
(ii) for which the applicant seeks a loan under
part A the principal amount of which does not exceed
$20,000.* deg.
recovery
Sec. 1622. [300s-1a] (a) If any facility with respect to
which funds have been paid under this title shall, at any time
within 20 years after the completion of construction or
modernization--* deg.
(1) be sold or transferred to any entity (A) which
is not qualified to file an application under section
1621 or 1642 or (B) which is not approved as a
transferee by the State Agency of the State in which
such facility is located, or its successor, or
(2) cease to be a public health center or a public
or other nonprofit hospital, outpatient facility,
facility for long-term care, or rehabilitation
facility,
the United States shall be entitled to recover, whether from
the transferor or the transferee (or, in the case of a facility
which has ceased to be public or nonprofit, from the owners
thereof) an amount determined under subsection (c).
(b) The transferor of a facility which is sold or
transferred as described in subsection (a)(1), or the owner of
a facility the use of which is changed as described in
subsection (a)(2), shall provide the Secretary written notice
of such sale, transfer, or change not later than the expiration
of 10 days from the date on which such sale, transfer, or
change occurs.
(c)(1) Except as provided in paragraph (2), the amount the
United States shall be entitled to recover under subsection (a)
is an amount bearing the same ratio to the then value (as
determined by the agreement of the parties or in an action
brought in the district court of the United States for the
district for which the facility involved is situated) of so
much of the facility as constituted an approved project or
projects as the amount of the Federal participation bore to the
cost of the construction or modernization of such project or
projects.
(2)(A) After the expiration of--
(i) 180 days after the date of the sale, transfer,
or change of use for which a notice is required by
subsection (b) in the case of a facility which is sold
or transferred or the use of which changes after the
date of the enactment of this subsection, or
(ii) thirty days after the date of enactment of
this subsection or if later 180 days after the date of
the sale, transfer, or change of use for which a notice
is required by subsection (b), in the case of a
facility which was sold or transferred or the use of
which changed before the date of the enactment of this
subsection,
the amount which the United States is entitled to recover under
paragraph (1) with respect to a facility shall be the amount
prescribed by paragraph (1) plus interest, during the period
described in subparagraph (B), at a rate (determined by the
Secretary) based on the average of the bond equivalent of the
weekly 90-day Treasury bill auction rate.
(B) The period referred to in subparagraph (A) is the
period beginning--
(i) in the case of a facility which was sold or
transferred or the use of which changed before the date
of the enactment of this subsection, thirty days after
such date or if later 180 days after the date of the
sale, transfer, or change of use for which a notice is
required by subsection (b),
(ii) in the case of a facility with respect to
which notice is provided in accordance with subsection
(b), upon the expiration of 180 days after the receipt
of such notice, or
(iii) in the case of a facility with respect to
which such notice is not provided as prescribed by
subsection (b), on the date of the sale, transfer, or
changes of use for which such notice was to be
provided,
and ending on the date the amount the United States is entitled
to under paragraph (1) is collected.
(d)(1) The Secretary may waive the recovery rights of the
United States under subsection (a)(1) with respect to a
facility in any State if the Secretary determines, in
accordance with regulations, that the entity to which the
facility was sold or transferred--
(A) has established an irrevocable trust--
(i) in an amount equal to the greater of
twice the cost of the remaining obligation of
the facility under clause (ii) of section
1621(b)(1)(K) or the amount, determined under
subsection (c), that the United States is
entitled to recover, and
(ii) which will only be used by the entity
to provide the care required by clause (ii) of
section 1621(b)(1)(K); and
(B) will meet the obligation of the facility under
clause (i) of section 1621(b)(1)(K).
(2) The Secretary may waive the recovery rights of the
United States under subsection (a)(2) with respect to a
facility in any State if the Secretary determines, in
accordance with regulations, that there is good cause for
waiving such rights with respect to such facility.
(e) The right of recovery of the United States under
subsection (a) shall not constitute a lien on any facility with
respect to which funds have been paid under this title.
control of operations
Sec. 1623. [300s-2] Except as otherwise specifically
provided, nothing in this title shall be construed as
conferring on any Federal officer, or employee the right to
exercise any supervision or control over the administration,
personnel, maintenance, or operation of any facility with
respect to which any funds have been or may be expended under
this title.
definitions
Sec. 1624. [300s-3] Except as provided in section 1642(e),
for purposes of this title--
(1) The term ``hospital'' includes general,
tuberculosis, and other types of hospitals, and related
facilities, such as laboratories, outpatient
departments, nurses' home facilities, extended care
facilities, facilities related to programs for home
health services, self-care units, and central service
facilities, operated in connection with hospitals, and
also includes education or training facilities for
health professonal \1\ personnel operated as an
integral part of a hospital, but does not include any
hospital furnishing primarily domiciliary care.
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\1\ So in law. Probably should be ``professional''.
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(2) The term ``public health center'' means a
publicly owned facility for the provision of public
health services, including related publicly owned
facilities such as laboratories, clinics, and
administrative offices operated in connection with such
a facility.
(3) The term ``nonprofit'' as applied to any
facility means a facility which is owned and operated
by one or more nonprofit corporations or associations
no part of the net earnings of which inures, or may
lawfully inure, to the benefit of any private
shareholder or individual.
(4) The term ``outpatient medical facility'' means
a medical facility (located in or apart from a
hospital) for the diagnosis or diagnosis and treatment
of ambulatory patients (including ambulatory
inpatients)--
(A) which is operated in connection with a
hospital;
(B) in which patient care is under the
professional supervision of persons licensed to
practice medicine or surgery in the State, or
in the case of dental diagnosis or treatment,
under the professional supervision of persons
licensed to practice dentistry in the State; or
(C) which offers to patients not requiring
hospitalization the services of licensed
physicians in various medical specialties and
which provides to its patients a reasonably
full range of diagnostic and treatment
services.
(5) The term ``rehabilitation facility'' means a
facility which is operated for the primary purpose of
assisting in the rehabilitation of disabled persons
through an integrated program of--
(A) medical evaluation and services, and
(B) psychological, social, or vocational
evaluation and services,
under competent professional supervision, and in the
case of which the major portion of the required
evaluation and services is furnished within the
facility; and either the facility is operated in
connection with a hospital, or all medical and related
health services are prescribed by, or are under the
general direction of, persons licensed to practice
medicine or surgery in the State.
(6) The term ``facility for long-term care'' means
a facility (including a skilled nursing or intermediate
care facility) providing in-patient care for
convalescent or chronic disease patients who required
skilled nursing or intermediate care and related
medical services--
(A) which is a hospital (other than a
hospital primarily for the care and treatment
of mentally ill or tuberculosis patients) or is
operated in connection with a hospital, or
(B) in which such care and medical services
are prescribed by, or are performed under the
general direction of, persons licensed to
practice medicine or surgery in the State.
(7) The term ``construction'' means construction of
new buildings and initial equipment of such buildings
and, in any case in which it will help to provide a
service not previously provided in the community,
equipment of any buildings; including architects' fees,
but excluding the cost of off-site improvements and,
except with respect to public health centers, the cost
of the acquisition of land
(8) The term ``cost'' as applied to construction
modernization, or conversion means the amount found by
the Secretary to be necessary for construction,
modernization, or conversion, respectively, under a
project, except that, in the case of a modernization
project or a project assisted under part D, such term
does not include any amount found by the Secretary to
be attributable to expansion of the bed capacity of any
facility.
(9) The term ``modernization'' includes the
alteration, expansion, major repair (to the extent
permitted by regulations), remodeling, replacement, and
renovation of existing buildings (including initial
equipment thereof), and the replacement of obsolete
equipment of existing buildings.
(10) The term ``title,'' \1\ when used with
reference to a site for a project, means a fee simple,
or such other estate or interest (including a leasehold
on which the rental does not exceed 4 per centum of the
value of the land) as the Secretary finds sufficient to
assure for a period of not less than twenty-five years'
undisturbed use and possession for the purposes of
construction, modernization, or conversion and
operation of the project for a period of not less than
(A) twenty years in the case of a project assisted
under an allotment or grant under this title, or (B)
the term of repayment of a loan made or guaranteed
under this title in the case of a project assisted by a
loan or loan guarantee.
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\1\ So in law. The comma probably should follow the ending
quotations.
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(11) The term ``medical facility'' means a
hospital, public health center, outpatient medical
facility, rehabilitation facility, facility for long-
term care, or other facility (as may be designated by
the Secretary) for the provision of health care to
ambulatory patients.
(12) The term ``State Agency'' means the State
health planning and development agency of a State
designated under title XV.
(13) The term ``urban or rural poverty area'' means
an urban or rural geographical area (as defined by the
Secretary) in which a percentage (as defined by the
Secretary in accordance with the next sentence) of the
residents of the area have incomes below the poverty
level (as defined by the Secretary of Commerce). The
percentage referred to in the preceding sentence shall
be defined so that the percentage of the population of
the United States residing in urban and rural poverty
areas is--
(A) not more than the percentage of the
total population of the United States with
incomes below the poverty level (as so defined)
plus five per centum, and
(B) not less than such percentage minus
five per centum.
(14) The term ``medically underserved population''
means the population of an urban or rural area
designated by the Secretary as an area with a shortage
of health facilities or a population group designated
by the Secretary as having a shortage of such
facilities.
financial statements; records and audit
Sec. 1625. [300s-4] (a) In the case of any facility for
which an allotment payment, grant, loan, or loan guarantee has
been made under this title, the applicant for such payment,
grant, loan, or loan guarantee (or, if appropriate, such other
person as the Secretary may prescribe) shall file at least
annually with the State Agency for the State in which the
facility is located a statement which shall be in such form,
and contain such information, as the Secretary may require to
accurately show--
(1) the financial operations of the facility, and
(2) the costs to the facility of providing health
services in the facility and the charges made by the
facility for providing such services,
during the period with respect to which the statement is filed.
(b)(1) Each entity receiving Federal assistance under this
title shall keep such records as the Secretary shall prescribe,
including records which fully disclose the amount and
disposition by such entity of the proceeds of such assistance,
the total cost of the project in connection with which such
assistance is given or used, the amount of that portion of the
cost of the project supplied by other sources, and such other
records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United
States, or any of their duly authorized representatives, shall
have access for the purpose of audit and examination to any
books, documents, papers, and records of such entities which in
the opinion of the Secretary or the Comptroller General may be
related or pertinent to the assistance referred to in paragraph
(1).
(c) Each such entity shall file at least annually with the
Secretary a statement which shall be in such form, and contain
such information, as the Secretary may require to accurately
show--
(1) the financial operations of the facility
constructed or modernized with such assistance, and
(2) the costs to such facility of providing health
services in such facility, and the charges made for
such services, during the period with respect to which
the statement is filed.
technical assistance
Sec. 1626. [300s-5] The Secretary shall provide (either
through the Department of Health, Education, and Welfare or by
contract) all necessary technical and other nonfinancial
assistance to any public or other entity which is eligible to
apply for assistance under this title to assist such entity in
developing applications to be submitted to the Secretary under
section 1621 or 1642. The Secretary shall make every effort to
inform eligible applicants of the availability of assistance
under this title.
enforcement of assurances
Sec. 1627. [300s-6] The Secretary shall investigate and
ascertain, on a periodic basis, with respect to each entity
which is receiving financial assistance under this title or
which has received financial assistance under title VI or this
title, the extent of compliance by such entity with the
assurances required to be made at the time such assistance was
received. If the Secretary finds that such an entity has failed
to comply with any such assurance, the Secretary shall report
such noncompliance to the health systems agency for the health
service area in which such entity is located and the State
health planning and development agency of the State in which
the entity is located and shall take any action authorized by
law (including an action for specific performance brought by
the Attorney General upon request of the Secretary) which will
effect compliance by the entity with such assurances. An action
to effectuate compliance with any such assurance may be brought
by a person other than the Secretary only if a complaint has
been filed by such person with the Secretary and the Secretary
has dismissed such complaint or the Attorney General has not
brought a civil action for compliance with such assurance
within six months after the date on which the complaint was
filed with the Secretary.
Part D--Area Health Services Development Funds
development grants for area health services development funds
Sec. 1640. [300t] (a) The Secretary shall make in each
fiscal year a grant to each health systems agency--
(1) with which there is in effect a designation
agreement under section 1515(c),
(2) which has in effect an HSP and AIP reviewed by
the Statewide Health Coordinating Council, and
(3) which, as determined under the review made
under section 1535(c), is organized and operated in the
manner prescribed by section 1512(b) and is performing
its functions under section 1513 in a manner
satisfactory to the Secretary,
to enable the agency to establish and maintain an Area Health
Services Development Fund from which it may make grants and
enter into contracts in accordance with section 1513(c)(3).
(b)(1) Except as provided in paragraph (2), the amount of
any grant under subsection (a) shall be determined by the
Secretary after taking into consideration the population of the
health service area for which the health systems agency is
designated, the average family income of the area, and the
supply of health services in the area.
(2) The amount of any grant under subsection (a) to a
health systems agency for any fiscal year may not exceed the
product of $1 and the population of the health service area for
which such agency is designated.
(c) No grant may be made under subsection (a) unless an
application therefor has been submitted to, and approved by,
the Secretary. Such an application shall be submitted in such
form and manner and contain such information as the Secretary
may require.
(d) For the purpose of making payments pursuant to grants
under subsection (a), there are authorized to be appropriated
$25,000,000 for the fiscal year ending June 30, 1975,
$75,000,000 for the fiscal year ending June 30, 1976,
$120,000,000 each for the fiscal years ending September 30,
1977, and September 30, 1978, $20,000,000 for the fiscal year
ending September 30, 1981, and $30,000,000 for the fiscal year
ending September 30, 1982.
Part E--Program To Assist and Encourage the Voluntary Discontinuance of
Unneeded Hospital Services and the Conversion of Unneeded Hospital
Services to Other Health Services Needed by the Community
establishment of program
Sec. 1641. [300t-11] The Secretary shall, by April 1, 1980,
establish a program under which--
(1) grants and technical assistance may be provided
to hospitals in operation on the date of the enactment
of this part (A) for the discontinuance of unneeded
hospital services, and (B) for the conversion of
unneeded hospital services to other health services
needed by the community; and
(2) grants may be provided to State Agencies
designated under section 1521(b)(3) for reducing
excesses in resources and facilities of hospitals.
grants for discontinuance and conversion
Sec. 1642. [300t-12] (a)(1) A grant to a hospital under the
program shall be subject to such terms and conditions as the
Secretary may by regulation prescribe to assure that the grant
is used for the purpose for which it was made.
(2) The amount of any such grant shall be determined by the
Secretary. The recipient of such a grant may use the grant--
(A) in the case of a grantee which discontinues the
provision of all hospital services or all inpatient
hospital services or an identifiable part of a hospital
facility which provides inpatient hospital services,
for the liquidation of the outstanding debt on the
facilities of the grantee used for the provision of the
services or for the liquidation of the outstanding debt
of the grantee on such identifiable part;
(B) in the case of a grantee which is discontinuing
the provision of an inpatient hospital service converts
or proposes to convert an identifiable part of a
hospital facility used in the provision of the
discontinued service to the delivery of other health
services, for the planning, development (including
construction and acquisition of equipment), and
delivery of the health service;
(C) to provide reasonable termination pay for
personnel of the grantee who will lose employment
because of the discontinuance of hospital services made
by the grantee, retraining of such personnel, assisting
such personnel in securing employment, and other costs
of implementing arrangements described in subsection
(c); and
(D) for such other costs which the Secretary
determines may need to be incurred by the grantee in
discontinuing hospital services.
(b)(1) No grant may be made to a hospital unless an
application therefor is submitted to and approved by the
Secretary. Such an application shall be in such form and
submitted in such manner as the Secretary may prescribe and
shall include--
(A) a description of each service to be
discontinued and, if a part of a hospital is to be
discontinued or converted to another use in connection
with such discontinuance, a description of such part;
(B) an evaluation of the impact of such
discontinuance and conversion on the provision of
health care in the health service area in which such
service is provided;
(C) an estimate of the change in the applicant's
costs which will result from such discontinuance and
conversion; and
(D) reasonable assurance that all laborers and
mechanics employed by contractors or subcontractors in
the performance of work on a project will be paid wages
at rates not less than those prevailing on similar
construction in the locality as determined by the
Secretary of Labor in accordance with the Act of March
3, 1931 (40 U.S.C. 276a--276a-5, known as the Davis-
Bacon Act), and the Secretary of Labor shall have with
respect to such labor standards the authority and
functions set forth in Reorganization Plan Numbered 14
of 1950 (15 FR 3176; 5 U.S.C. Appendix) and section 2
of the Act of June 13, 1934 (40 U.S.C. 276c);
(E) such other information as the Secretary may
require.
(2)(A) The health systems agency for the health service
area in which is located a hospital applying for a grant under
the program shall (i) in making the review of the applicant's
application under section 1513(e), determine the need for each
service or part proposed to be discontinued by the applicant,
(ii) in the case of an application for the conversion of a
facility, determine the need for each service which will be
provided as a result of a conversion, and (iii) make a
recommendation to the State Agency for the State in which the
applicant is located respecting approval by the Secretary of
the applicant's application.
(B) A State Agency which has received a recommendation from
a health systems agency under subparagraph (A) respecting an
application shall, after consideration of such recommendation,
make a recommendation to the Secretary respecting the approval
by the Secretary of the application. A State Agency's
recommendation under this subparagraph respecting the approval
of an application (i) shall be based upon (I) the need for each
service or part proposed to be discontinued by the applicant,
(II) in the case of an application for the conversion of a
facility, the need for each service which will be provided as a
result of the conversion, and (III) such other criteria as the
Secretary may prescribe, and (ii) shall be accompanied by the
health systems agency's recommendation made with respect to the
approval of the application.
(C) In determining, under subparagraphs (A) and (B), the
need for the service (or services) or part proposed to be
discontinued or converted by an applicant for a grant, a health
systems agency and State Agency shall give special
consideration to the unmet needs and existing access patterns
of urban or rural poverty populations.
(3)(A) The Secretary may not approve an application of a
hospital for a grant--
(i) if a State Agency recommended that the
application not be approved, or
(ii) if the Secretary is unable to determine that
the cost of providing inpatient health services in the
health service area in which the applicant is located
will be less than if the inpatient health services
proposed to be discontinued were not discontinued.
(B) In considering applications of hospitals for grants the
Secretary shall consider the recommendations of health systems
agencies and State Agencies and shall give special
consideration to applications (i) which will assist health
systems agencies and State Agencies to meet the goals in their
health systems plans and State health plans, or (ii) which will
result in the greatest reduction in hospital costs within a
health service area.
(c)(1) Except as provided in paragraph (3), the Secretary
may not approve an application submitted under subsection (b)
unless the Secretary of Labor has certified that fair and
equitable arrangements have been made to protect the interests
of employees affected by the discontinuance of services against
a worsening of their positions with respect to their
employment, including arrangements to preserve the rights of
employees under collective-bargaining agreements, continuation
of collective-bargaining rights consistent with the provisions
of the National Labor Relations Act, reassignment of affected
employees to other jobs, retraining programs, protecting
pension, health benefits, and other fringe benefits of affected
employees, and arranging adequate severance pay, if necessary.
(2) The Secretary of Labor shall by regulation prescribe
guidelines for arrangements for the protection of the interests
of employees affected by the discontinuance of hospital
services. The Secretary of Labor shall consult with the
Secretary of Health, Education, and Welfare in the promulgation
of such guidelines. Such guidelines shall first be promulgated
not later than the promulgation of regulations by the Secretary
for the administration of the grants authorized by section
1641.
(3) The Secretary of Labor shall review each application
submitted under subsection (b) to determine if the arrangements
described in paragraph (1) have been made and if they are
satisfactory and shall notify the Secretary respecting his
determination. Such review shall be completed within--
(A) ninety days from the date of the receipt of the
application from the Secretary of Health, Education,
and Welfare, or
(B) one hundred and twenty days from such date if
the Secretary of Labor has by regulation prescribed the
circumstances under which the review will require at
least one hundred and twenty days.
If within the applicable period, the Secretary of Labor does
not notify the Secretary of Health, Education, and Welfare
respecting his determination, the Secretary of Health,
Education, and Welfare shall review the application to
determine if the applicant has made the arrangements described
in paragraph (1) and if such arrangements are satisfactory. The
Secretary may not approve the application unless he determines
that such arrangements have been made and that they are
satisfactory.
(d) The records and audits requirements of section 705
shall apply with respect to grants made under subsection (a).
(e) For purposes of this part, the term ``hospital'' means,
with respect to any fiscal year, an institution (including a
distinct part of an institution participating in the programs
established under title XVIII of the Social Security Act)--
(1) which satisfies paragraphs (1) and (7) of
section 1861(e) of such Act,
(2) imposes charges or accepts payments for
services provided to patients, and
(3) the average duration of a patient's stay in
which was thirty days or less in the preceding fiscal
year,
but such term does not include a Federal hospital or a
psychiatric hospital (as described in section 1861(f)(1) of the
Social Security Act).
grants to states for reduction of excess hospital capacity
Sec. 1643. [300t-13] (a) For the purpose of demonstrating
the effectiveness of various means for reducing excesses in
resources and facilities of hospitals (referred to in this
section as ``excess hospital capacity''), the Secretary may
make grants to State Agencies designated under section
1521(b)(3) to assist such Agencies in--
(1) identifying (by geographic region or by health
service) excess hospital capacity,
(2) developing programs to inform the public of the
costs associated with excess hospital capacity,
(3) developing programs to reduce excess hospital
capacity in a manner which will produce the greatest
savings in the cost of health care delivery,
(4) developing means to overcome barriers to the
reduction of excess hospital capacity,
(5) in planning, evaluating, and carrying out
programs to decertify health care facilities providing
health services that are not appropriate, and
(6) any other activity related to the reduction of
excess hospital capacity.
(b) Grants under subsection (a) shall be made on such terms
and conditions as the Secretary may prescribe.
authorization of appropriations
Sec. 1644. [300t-14] To make payments under grants under
sections 1642 and 1643 there are authorized to be appropriated
$30,000,000 for the fiscal year ending September 30, 1980,
$50,000,000 for the fiscal year ending September 30, 1981, and
$75,000,000 for the fiscal year ending September 30, 1982,
except that in any fiscal year not more than 10 percent of the
amount appropriated under this section may be obligated for
grants under section 1643.ATTORNEY: CAS (March 29,
2000) deg.
TITLE XVII--HEALTH INFORMATION AND HEALTH PROMOTION
general authority
Sec. 1701. [300u] (a) The Secretary shall--
(1) formulate national goals, and a strategy to
achieve such goals, with respect to health information
and health promotion, preventive health services, and
education in the appropriate use of health care;
(2) analyze the necessary and available resources
for implementing the goals and strategy formulated
pursuant to paragraph (1), and recommend appropriate
educational and quality assurance policies for the
needed manpower resources identified by such analysis;
(3) undertake and support necessary activities and
programs to--
(A) incorporate appropriate health
education components into our society,
especially into all aspects of education and
health care,
(B) increase the application and use of
health knowledge, skills, and practices by the
general population in its patterns of daily
living, and
(C) establish systematic processes for the
exploration, development, demonstration, and
evaluation of innovative health promotion
concepts;
(4) undertake and support research and
demonstrations respecting health information and health
promotion, preventive health services, and education in
the appropriate use of health care;
(5) undertake and support appropriate training in
the operation of programs concerned with, health
information and health promotion, preventive health
services, and education in the appropriate use of
health care;
(6) undertake and support, through improved
planning and implementation of tested models and
evaluation of results, effective and efficient programs
respecting health information and health promotion,
preventive health services, and education in the
appropriate use of health care;
(7)(A) develop model programs through which
employers in the public sector, and employers that are
small businesses (as defined in section 3 of the Small
Business Act), can provide for their employees a
program to promote healthy behaviors and to discourage
participation in unhealthy behaviors;
(B) provide technical assistance to public and
private employers in implementing such programs
(including private employers that are not small
businesses and that will implement programs other than
the programs developed by the Secretary pursuant to
subparagraph (A)); and
(C) in providing such technical assistance, give
preference to small businesses;
(8) foster the exchange of information respecting,
and foster cooperation in the conduct of, research,
demonstration, and training programs respecting health
information and health promotion, preventive health
services, and education in the appropriate use of
health care;
(9) provide technical assistance in the programs
referred to in paragraph (8);
(10) use such other authorities for programs
respecting health information and health promotion,
preventive health services, and education in the
appropriate use of health care as are available and
coordinate such use with programs conducted under this
title; and
(11) establish in the Office of the Assistant
Secretary for Health an Office of Disease Prevention
and Health Promotion, which shall--
(A) coordinate all activities within the
Department which relate to disease prevention,
health promotion, preventive health services,
and health information and education with
respect to the appropriate use of health care;
(B) coordinate such activities with similar
activities in the private sector;
(C) establish a national information
clearinghouse to facilitate the exchange of
information concerning matters relating to
health information and health promotion,
preventive health services (which may include
information concerning models and standards for
insurance coverage of such services), and
education in the appropriate use of health
care, to facilitate access to such information,
and to assist in the analysis of issues and
problems relating to such matters; and
(D) support projects, conduct research, and
disseminate information relating to preventive
medicine, health promotion, and physical
fitness and sports medicine.
The Secretary shall appoint a Director for the Office of
Disease Prevention and Health Promotion established pursuant to
paragraph (11) of this subsection. The Secretary shall
administer this title in cooperation with health care
providers, educators, voluntary organizations, businesses, and
State and local health agencies in order to encourage the
dissemination of health information and health promotion
activities.
(b) For the purpose of carrying out this section and
sections 1702 through 1705, there are authorized to be
appropriated $10,000,000 for fiscal year 1992, and such sums as
may be necessary for each of the fiscal years 1993 through
2002.
(c) No grant may be made or contract entered into under
this title unless an application therefor has been submitted to
and approved by the Secretary. Such an application shall be
submitted in such form and manner and contain such information
as the Secretary may prescribe. Contracts may be entered into
under this title without regard to sections 3648 and 3709 of
the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).
research programs
Sec. 1702. [300u-1] (a) The Secretary is authorized to
conduct and support by grant or contract (and encourage others
to support) research in health information and health
promotion, preventive health services, and education in the
appropriate use of health care. Applications for grants and
contracts under this section shall be subject to appropriate
peer review. The Secretary shall also--
(1) provide consultation and technical assistance
to persons who need help in preparing research
proposals or in actually conducting research;
(2) determine the best methods of disseminating
information concerning personal health behavior,
preventive health services and the appropriate use of
health care and of affecting behavior so that such
information is applied to maintain and improve health,
and prevent disease, reduce its risk, or modify its
course or severity;
(3) determine and study environmental,
occupational, social, and behavioral factors which
affect and determine health and ascertain those
programs and areas for which educational and preventive
measures could be implemented to improve health as it
is affected by such factors;
(4) develop (A) methods by which the cost and
effectiveness of activities respecting health
information and health promotion, preventive health
services, and education in the appropriate use of
health care, can be measured, including methods for
evaluating the effectiveness of various settings for
such activities and the various types of persons
engaged in such activities, (B) methods for
reimbursement or payment for such activities, and (C)
models and standards for the conduct of such
activities, including models and standards for the
education, by providers of institutional health
services, of individuals receiving such services
respecting the nature of the institutional health
services provided the individuals and the symptoms,
signs, or diagnoses which led to provision of such
services;
(5) develop a method for assessing the cost and
effectiveness of specific medical services and
procedures under various conditions of use, including
the assessment of the sensitivity and specificity of
screening and diagnostic procedures; and
(6) enumerate and assess, using methods developed
under paragraph (5), preventive health measures and
services with respect to their cost and effectiveness
under various conditions of use (which measures and
services may include blood pressure screening,
cholesterol screening and control, smoking cessation
programs, substance abuse programs, cancer screening,
dietary and nutritional counseling, diabetes screening
and education, intraocular pressure screening, and
stress management).
(b) The Secretary shall make a periodic survey of the
needs, interest, attitudes, knowledge, and behavior of the
American public regarding health and health care. The Secretary
shall take into consideration the findings of such surveys and
the findings of similar surveys conducted by national and
community health education organizations, and other
organizations and agencies for formulating policy respecting
health information and health promotion, preventive health
services, and education in the appropriate use of health care.
community programs
Sec. 1703. [300u-2] (a) The Secretary is authorized to
conduct and support by grant or contract (and encourage others
to support) new and innovative programs in health information
and health promotion, preventive health services, and education
in the appropriate use of health care, and may specifically--
(1) support demonstration and training programs in
such matters which programs (A) are in hospitals,
ambulatory care settings, home care settings, schools,
day care programs for children, and other appropriate
settings representative of broad cross sections of the
population, and include public education activities of
voluntary health agencies, professional medical
societies, and other private nonprofit health
organizations, (B) focus on objectives that are
measurable, and (C) emphasize the prevention or
moderation of illness or accidents that appear
controllable through individual knowledge and behavior;
(2) provide consultation and technical assistance
to organizations that request help in planning,
operating, or evaluating programs in such matters;
(3) develop health information and health promotion
materials and teaching programs including (A) model
curriculums for the training of educational and health
professionals and paraprofessionals in health education
by medical, dental, and nursing schools, schools of
public health, and other institutions engaged in
training of educational or health professionals, (B)
model curriculums to be used in elementary and
secondary schools and institutions of higher learning,
(C) materials and programs for the continuing education
of health professionals and paraprofessionals in the
health education of their patients, (D) materials for
public service use by the printed and broadcast media,
and (E) materials and programs to assist providers of
health care in providing health education to their
patients; and
(4) support demonstration and evaluation programs
for individual and group self-help programs designed to
assist the participant in using his individual
capacities to deal with health problems, including
programs concerned with obesity, hypertension, and
diabetes.
(b) The Secretary is authorized to make grants to States
and other public and nonprofit entities to assist them in
meeting the costs of demonstrating and evaluating programs
which provide information respecting the costs and quality of
health care or information respecting health insurance policies
and prepaid health plans, or information respecting both. After
the development of models pursuant to sections 1704(4) and
1704(5) for such information, no grant may be made under this
subsection for a program unless the information to be provided
under the program is provided in accordance with one of such
models applicable to the information.
(c) The Secretary is authorized to support by grant or
contract (and to encourage others to support) private nonprofit
entities working in health information and health promotion,
preventive health services, and education in the appropriate
use of health care. The amount of any grant or contract for a
fiscal year beginning after September 30, 1978, for an entity
may not exceed 25 per centum of the expenses of entity for such
fiscal year for health information and health promotion,
preventive health services, and education in the appropriate
use of health care.
information programs
Sec. 1704. [300u-3] The Secretary is authorized to conduct
and support by grant or contract (and encourage others to
support) such activities as may be required to make information
respecting health information and health promotion, preventive
health services, and education in the appropriate use of health
care available to the consumers of medical care, providers of
such care, schools, and others who are or should be informed
respecting such matters. Such activities may include at least
the following:
(1) The publication of information, pamphlets, and
other reports which are specially suited to interest
and instruct the health consumer, which information,
pamphlets, and other reports shall be updated annually,
shall pertain to the individual's ability to improve
and safeguard his own health; shall include material,
accompanied by suitable illustrations, on child care,
family life and human development, disease prevention
(particularly prevention of pulmonary disease,
cardiovascular disease, and cancer), physical fitness,
dental health, environmental health, nutrition, safety
and accident prevention, drug abuse and alcoholism,
mental health, management of chronic diseases
(including diabetes and arthritis), and venereal
diseases; and shall be designed to reach populations of
different languages and of different social and
economic backgrounds.
(2) Securing the cooperation of the communication
media, providers of health care, schools, and others in
activities designed to promote and encourage the use of
health maintaining information and behavior.
(3) The study of health information and promotion
in advertising and the making to concerned Federal
agencies and others such recommendations respecting
such advertising as are appropriate.
(4) The development of models and standards for the
publication by States, insurance carriers, prepaid
health plans, and others (except individual health
practitioners) of information for use by the public
respecting the cost and quality of health care,
including information to enable the public to make
comparisons of the cost and quality of health care.
(5) The development of models and standards for the
publication by States, insurance carriers, prepaid
health plans, and others of information for use by the
public respecting health insurance policies and prepaid
health plans, including information on the benefits
provided by the various types of such policies and
plans, the premium charges for such policies and plans,
exclusions from coverage or eligibility for coverage,
cost sharing requirements, and the ratio of the amounts
paid as benefits to the amounts received as premiums
and information to enable the public to make relevant
comparisons of the costs and benefits of such policies
and plans.
report and study
Sec. 1705. [300u-4] (a) The Secretary shall, not later than
two years after the date of the enactment of this title and
biannually thereafter, submit to the President for transmittal
to Congress a report on the status of health information and
health promotion, preventive health services, and education in
the appropriate use of health care. Each such report shall
include--
(1) a statement of the activities carried out under
this title since the last report and the extent to
which each such activity achieves the purposes of this
title;
(2) an assessment of the manpower resources needed
to carry out programs relating to health information
and health promotion, preventive health services, and
education in the appropriate use of health care, and a
statement describing the activities currently being
carried out under this title designed to prepare
teachers and other manpower for such programs;
(3) the goals and strategy formulated pursuant to
section 1701(a)(1), the models and standards developed
under this title, and the results of the study required
by subsection (b) of this section; and
(4) such recommendations as the Secretary considers
appropriate for legislation respecting health
information and health promotion, preventive health
services, and education in the appropriate use of
health care, including recommendations for revisions to
and extension of this title.
(b) The Secretary shall conduct a study of health education
services and preventive health services to determine the
coverage of such services under public and private health
insurance programs, including the extent and nature of such
coverage and the cost sharing requirements required by such
programs for coverage of such services.
centers for research and demonstration of health promotion and disease
prevention
Sec. 1706. [300u-5] (a) The Secretary shall make grants or
enter into contracts with academic health centers for the
establishment, maintenance, and operation of centers for
research and demonstration with respect to health promotion and
disease prevention. Centers established, maintained, or
operated under this section shall undertake research and
demonstration projects in health promotion, disease prevention,
and improved methods of appraising health hazards and risk
factors, and shall serve as demonstration sites for the use of
new and innovative research in public health techniques to
prevent chronic diseases.
(b) Each center established, maintained, or operated under
this section shall--
(1) be located in an academic health center with--
(A) a multidisciplinary faculty with
expertise in public health and which has
working relationships with relevant groups in
such fields as medicine, psychology, nursing,
social work, education and business;
(B) graduate training programs relevant to
disease prevention;
(C) a core faculty in epidemiology,
biostatistics, social sciences, behavioral and
environmental health sciences, and health
administration;
(D) a demonstrated curriculum in disease
prevention;
(E) a capability for residency training in
public health or preventive medicine; and
(F) such other qualifications as the
Secretary may prescribe;
(2) conduct--
(A) health promotion and disease prevention
research, including retrospective studies and
longitudinal prospective studies in population
groups and communities;
(B) demonstration projects for the delivery
of services relating to health promotion and
disease prevention to defined population groups
using, as appropriate, community outreach and
organization techniques and other methods of
educating and motivating communities; and
(C) evaluation studies on the efficacy of
demonstration projects conducted under
subparagraph (B) of this paragraph.
The design of any evaluation study conducted under subparagraph
(C) shall be established prior to the commencement of the
demonstration project under subparagraph (B) for which the
evaluation will be conducted.
(c)(1) In making grants and entering into contracts under
this section, the Secretary shall provide for an equitable
geographical distribution of centers established, maintained,
and operated under this section and for the distribution of
such centers among areas containing a wide range of population
groups which exhibit incidences of diseases which are most
amenable to preventive intervention.
(2) The Secretary, through the Director of the Centers for
Disease Control and Prevention and in consultation with the
Director of the National Institutes of Health, shall establish
procedures for the appropriate peer review of applications for
grants and contracts under this section by peer review groups
composed principally of non-Federal experts.
(d) For purposes of this section, the term ``academic
health center'' means a school of medicine, a school of
osteopathy, or a school of public health, as such terms are
defined in section 701(4).
(e) For the purpose of carrying out this section, there are
authorized to be appropriated $10,000,000 for fiscal year 1992,
and such sums as may be necessary for each of the fiscal years
1993 through 2003.
office of minority health
Sec. 1707. [300u-6] (a) In General.--There is established
an Office of Minority Health. The Office of Minority Health as
existing on the date of enactment of the Patient Protection and
Affordable Care Act shall be transferred to the Office of the
Secretary in such manner that there is established in the
Office of the Secretary, the Office of Minority Health, which
shall be headed by the Deputy Assistant Secretary for Minority
Health who shall report directly to the Secretary, and shall
retain and strengthen authorities (as in existence on such date
of enactment) for the purpose of improving minority health and
the quality of health care minorities receive, and eliminating
racial and ethnic disparities. In carrying out this subsection,
the Secretary, acting through the Deputy Assistant Secretary,
shall award grants, contracts, enter into memoranda of
understanding, cooperative, interagency, intra-agency and other
agreements with public and nonprofit private entities,
agencies, as well as Departmental and Cabinet agencies and
organizations, and with organizations that are indigenous human
resource providers in communities of color to assure improved
health status of racial and ethnic minorities, and shall
develop measures to evaluate the effectiveness of activities
aimed at reducing health disparities and supporting the local
community. Such measures shall evaluate community outreach
activities, language services, workforce cultural competence,
and other areas as determined by the Secretary.
(b) Duties.--With respect to improving the health of racial
and ethnic minority groups, the Secretary, acting through the
Deputy Assistant Secretary for Minority Health (in this section
referred to as the ``Deputy Assistant Secretary''), shall carry
out the following:
(1) Establish short-range and long-range goals and
objectives and coordinate all other activities within
the Public Health Service that relate to disease
prevention, health promotion, service delivery, and
research concerning such individuals. The heads of each
of the agencies of the Service shall consult with the
Deputy Assistant Secretary to ensure the coordination
of such activities.
(2) Enter into interagency agreements with other
agencies of the Public Health Service.
(3) Support research, demonstrations and
evaluations to test new and innovative models.
(4) Increase knowledge and understanding of health
risk factors.
(5) Develop mechanisms that support better
information dissemination, education, prevention, and
service delivery to individuals from disadvantaged
backgrounds, including individuals who are members of
racial or ethnic minority groups.
(6) Ensure that the National Center for Health
Statistics collects data on the health status of each
minority group.
(7) With respect to individuals who lack
proficiency in speaking the English language, enter
into contracts with public and nonprofit private
providers of primary health services for the purpose of
increasing the access of the individuals to such
services by developing and carrying out programs to
provide bilingual or interpretive services.
(8) Support a national minority health resource
center to carry out the following:
(A) Facilitate the exchange of information
regarding matters relating to health
information and health promotion, preventive
health services, and education in the
appropriate use of health care.
(B) Facilitate access to such information.
(C) Assist in the analysis of issues and
problems relating to such matters.
(D) Provide technical assistance with
respect to the exchange of such information
(including facilitating the development of
materials for such technical assistance).
(9) Carry out programs to improve access to health
care services for individuals with limited proficiency
in speaking the English language. Activities under the
preceding sentence shall include developing and
evaluating model projects.
(10) Advise in matters related to the development,
implementation, and evaluation of health professions
education in decreasing disparities in health care
outcomes, including cultural competency as a method of
eliminating health disparities.
(c) Advisory Committee.--
(1) In general.--The Secretary shall establish an
advisory committee to be known as the Advisory
Committee on Minority Health (in this subsection
referred to as the ``Committee'').
(2) Duties.--The Committee shall provide advice to
the Deputy Assistant Secretary carrying out this
section, including advice on the development of goals
and specific program activities under paragraphs (1)
through (10) of subsection (b) for each racial and
ethnic minority group.
(3) Chair.--The chairperson of the Committee shall
be selected by the Secretary from among the members of
the voting members of the Committee. The term of office
of the chairperson shall be 2 years.
(4) Composition.--
(A) The Committee shall be composed of 12
voting members appointed in accordance with
subparagraph (B), and nonvoting, ex officio
members designated in subparagraph (C).
(B) The voting members of the Committee
shall be appointed by the Secretary from among
individuals who are not officers or employees
of the Federal Government and who have
expertise regarding issues of minority health.
The racial and ethnic minority groups shall be
equally represented among such members.
(C) The nonvoting, ex officio members of
the Committee shall be such officials of the
Department of Health and Human Services as the
Secretary determines to be appropriate.
(5) Terms.--Each member of the Committee shall
serve for a term of 4 years, except that the Secretary
shall initially appoint a portion of the members to
terms of 1 year, 2 years, and 3 years.
(6) Vacancies.--If a vacancy occurs on the
Committee, a new member shall be appointed by the
Secretary within 90 days from the date that the vacancy
occurs, and serve for the remainder of the term for
which the predecessor of such member was appointed. The
vacancy shall not affect the power of the remaining
members to execute the duties of the Committee.
(7) Compensation.--Members of the Committee who are
officers or employees of the United States shall serve
without compensation. Members of the Committee who are
not officers or employees of the United States shall
receive compensation, for each day (including travel
time) they are engaged in the performance of the
functions of the Committee. Such compensation may not
be in an amount in excess of the daily equivalent of
the annual maximum rate of basic pay payable under the
General Schedule (under title 5, United States Code)
for positions above GS-15.
(d) Certain Requirements Regarding Duties.--
(1) Recommendations regarding language.--
(A) Proficiency in speaking english.--The
Deputy Assistant Secretary shall consult with
the Director of the Office of International and
Refugee Health, the Director of the Office of
Civil Rights, and the Directors of other
appropriate departmental entities regarding
recommendations for carrying out activities
under subsection (b)(9).
(B) Health professions education regarding
health disparities.--The Deputy Assistant
Secretary shall carry out the duties under
subsection (b)(10) in collaboration with
appropriate personnel of the Department of
Health and Human Services, other Federal
agencies, and other offices, centers, and
institutions, as appropriate, that have
responsibilities under the Minority Health and
Health Disparities Research and Education Act
of 2000.
(2) Equitable allocation regarding activities.--In
carrying out subsection (b), the Secretary shall ensure
that services provided under such subsection are
equitably allocated among all groups served under this
section by the Secretary.
(3) Cultural competency of services.--The Secretary
shall ensure that information and services provided
pursuant to subsection (b) are provided in the
language, educational, and cultural context that is
most appropriate for the individuals for whom the
information and services are intended.
(e) Grants and Contracts Regarding Duties.--
(1) In general.--In carrying out subsection (b),
the Secretary acting through the Deputy Assistant
Secretary may make awards of grants, cooperative
agreements, and contracts to public and nonprofit
private entities.
(2) Process for making awards.--The Deputy
Assistant Secretary shall ensure that awards under
paragraph (1) are made, to the extent practical, only
on a competitive basis, and that a grant is awarded for
a proposal only if the proposal has been recommended
for such an award through a process of peer review.
(3) Evaluation and dissemination.--The Deputy
Assistant Secretary, directly or through contracts with
public and private entities, shall provide for
evaluations of projects carried out with awards made
under paragraph (1) during the preceding 2 fiscal
years. The report shall be included in the report
required under subsection (f) for the fiscal year
involved.
(f) Reports.--
(1) In general.--Not later than February 1 of
fiscal year 1999 and of each second year thereafter,
the Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives, and to
the Committee on Labor and Human Resources of the
Senate, a report describing the activities carried out
under this section during the preceding 2 fiscal years
and evaluating the extent to which such activities have
been effective in improving the health of racial and
ethnic minority groups. Each such report shall include
the biennial reports submitted under sections 201(e)(3)
and 201(f)(2) for such years by the heads of the Public
Health Service agencies.
(2) Agency reports.--Not later than February 1,
1999, and biennially thereafter, the heads of the
Public Health Service agencies shall submit to the
Deputy Assistant Secretary a report summarizing the
minority health activities of each of the respective
agencies.
(g) Definition.--For purposes of this section:
(1) The term ``racial and ethnic minority group''
means American Indians (including Alaska Natives,
Eskimos, and Aleuts); Asian Americans; Native Hawaiians
and other Pacific Islanders; Blacks; and Hispanics.
(2) The term ``Hispanic'' means individuals whose
origin is Mexican, Puerto Rican, Cuban, Central or
South American, or any other Spanish-speaking country.
(h) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2011 through 2016.
SEC. 1707A. [300U-6A] INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE
DEPARTMENT.
(a) In General.--The head of each agency specified in
subsection (b)(1) shall establish within the agency an office
to be known as the Office of Minority Health. The head of each
such Office shall be appointed by the head of the agency within
which the Office is established, and shall report directly to
the head of the agency. The head of such agency shall carry out
this section (as this section relates to the agency) acting
through such Director.
(b) Specified Agencies.--The agencies referred to in
subsection (a) are the Centers for Disease Control and
Prevention, the Health Resources and Services Administration,
the Substance Abuse and Mental Health Services Administration,
the Agency for Healthcare Research and Quality, the Food and
Drug Administration, and the Centers for Medicare & Medicaid
Services.
(c) Director; Appointment.--Each Office of Minority Health
established in an agency listed in subsection (a) shall be
headed by a director, with documented experience and expertise
in minority health services research and health disparities
elimination.
(d) References.--Except as otherwise specified, any
reference in Federal law to an Office of Minority Health (in
the Department of Health and Human Services) is deemed to be a
reference to the Office of Minority Health in the Office of the
Secretary.
(e) Funding.--
(1) Allocations.--Of the amounts appropriated for a
specified agency for a fiscal year, the Secretary must
designate an appropriate amount of funds for the
purpose of carrying out activities under this section
through the minority health office of the agency. In
reserving an amount under the preceding sentence for a
minority health office for a fiscal year, the Secretary
shall reduce, by substantially the same percentage, the
amount that otherwise would be available for each of
the programs of the designated agency involved.
(2) Availability of funds for staffing.--The
purposes for which amounts made available under
paragraph may be expended by a minority health office
include the costs of employing staff for such office.
office of adolescent health
Sec. 1708. [300u-7] (a) In General.--There is established
an Office of Adolescent Health within the Office of the
Assistant Secretary for Health, which office shall be headed by
a director appointed by the Secretary. The Secretary shall
carry out this section acting through the Director of such
Office.
(b) Duties.--With respect to adolescent health, the
Secretary shall--
(1) coordinate all activities within the Department
of Health and Human Services that relate to disease
prevention, health promotion, preventive health
services, and health information and education with
respect to the appropriate use of health care,
including coordinating--
(A) the design of programs, support for
programs, and the evaluation of programs;
(B) the monitoring of trends;
(C) projects of research (including
multidisciplinary projects) on adolescent
health; and
(D) the training of health providers who
work with adolescents, particularly nurse
practitioners, physician assistants, and social
workers;
(2) coordinate the activities described in
paragraph (1) with similar activities in the private
sector; and
(3) support projects, conduct research, and
disseminate information relating to preventive
medicine, health promotion, and physical fitness and
sports medicine.
(c) Certain Demonstration Projects.--
(1) In general.--In carrying out subsection (b)(3),
the Secretary may make grants to carry out
demonstration projects for the purpose of improving
adolescent health, including projects to train health
care providers in providing services to adolescents and
projects to reduce the incidence of violence among
adolescents, particularly among minority males.
(2) Authorization of appropriations.--For the
purpose of carrying out paragraph (1), there are
authorized to be appropriated $5,000,000 for fiscal
year 1993, and such sums as may be necessary for each
of the fiscal years 1994 through 1997.
(d) Information Clearinghouse.--In carrying out subsection
(b), the Secretary shall establish and maintain a National
Information Clearinghouse on Adolescent Health to collect and
disseminate to health professionals and the general public
information on adolescent health.
(e) National Plan.--In carrying out subsection (b), the
Secretary shall develop a national plan for improving
adolescent health. The plan shall be consistent with the
applicable objectives established by the Secretary for the
health status of the people of the United States for the year
2000, and shall be periodically reviewed, and as appropriate,
revised. The plan, and any revisions in the plan, shall be
submitted to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and Human
Resources of the Senate.
(f) Adolescent Health.--For purposes of this section, the
term ``adolescent health'', with respect to adolescents of all
ethnic and racial groups, means all diseases, disorders, and
conditions (including with respect to mental health)--
(1) unique to adolescents, or more serious or more
prevalent in adolescents;
(2) for which the factors of medical risk or types
of medical intervention are different for adolescents,
or for which it is unknown whether such factors or
types are different for adolescents; or
(3) with respect to which there has been
insufficient clinical research involving adolescents as
subjects or insufficient clinical data on adolescents.
biennial report regarding nutrition and health
Sec. 1709. [300u-8] (a) Biennial Report.--The Secretary
shall require the Surgeon General of the Public Health Service
to prepare biennial reports on the relationship between
nutrition and health. Such reports may, with respect to such
relationship, include any recommendations of the Secretary and
the Surgeon General.
(b) Submission to Congress.--The Secretary shall ensure
that, not later than February 1 of 1995 and of every second
year thereafter, a report under subsection (a) is submitted to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate.
education regarding des
Sec. 1710. [300u-9] (a) In General.--The Secretary, acting
through the heads of the appropriate agencies of the Public
Health Service, shall carry out a national program for the
education of health professionals and the public with respect
to the drug diethylstilbestrol (commonly known as DES). To the
extent appropriate, such national program shall use
methodologies developed through the education demonstration
program carried out under section 403C. In developing and
carrying out the national program, the Secretary shall consult
closely with representatives of nonprofit private entities that
represent individuals who have been exposed to DES and that
have expertise in community-based information campaigns for the
public and for health care providers. The implementation of the
national program shall begin during fiscal year 1999.
(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 1999 through 2003. The authorization of
appropriations established in the preceding sentence is in
addition to any other authorization of appropriation that is
available for such purpose.
TITLE XVIII--PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS
IN MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH
establishment of commission
Sec. 1801. [300v] (a) Establishment.--(1) There is
established the President's Commission for the Study of Ethical
Problems in Medicine and Biomedical and Behavioral Research \1\
(hereinafter in this title referred to as the ``Commission'')
which shall be composed of eleven members appointed by the
President. The members of the Commission shall be appointed as
follows:
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\1\ Such a Commission was established on December 17, 1979, by
Executive Order No. 12184 (44 Fed. Reg. 75091). The Executive Order was
revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed.
Reg. 7237).
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(A) Three of the members shall be appointed from
individuals who are distinguished in biomedical or
behavioral research.
(B) Three of the members shall be appointed from
individuals who are distinguished in the practice of
medicine or otherwise distinguished in the provision of
health care.
(C) Five of the members shall be appointed from
individuals who are distinguished in one or more of the
fields of ethics, theology, law, the natural sciences
(other than a biomedical or behavioral science), the
social sciences, the humanities, health administration,
government, and public affairs.
(2) No individual who is a full-time officer or employee of
the United States may be appointed as a member of the
Commission. The Secretary of Health, Education, and Welfare,
the Secretary of Defense, the Director of Central Intelligence,
the Director of the Office of Science and Technology Policy,
the Administrator of Veterans' Affairs, and the Director of the
National Science Foundation shall each designate an individual
to provide liaison with the Commission.
(3) No individual may be appointed to serve as a member of
the Commission if the individual has served for two terms of
four years each as such a member.
(4) A vacancy in the Commission shall be filled in the
manner in which the original appointment was made.
(b) Terms.--(1) Except as provided in paragraphs (2) and
(3), members shall be appointed for terms of four years.
(2) Of the members first appointed--
(A) four shall be appointed for terms of three
years, and
(B) three shall be appointed for terms of two
years,
as designated by the President at the time of appointment.
(3) Any member appointed to fill a vacancy occurring before
the expiration of the term for which his predecessor was
appointed shall be appointed only for the remainder of such
term. A member may serve after the expiration of his term until
his successor has taken office.
(c) Chairman.--The Chairman of the Commission shall be
appointed by the President, by and with the advice and consent
of the Senate, from members of the Commission.
(d) Meetings.--(1) Seven members of the Commission shall
constitute a quorum for business, but a lesser number may
conduct hearings.
(2) The Commission shall meet at the call of the Chairman
or at the call of a majority of its members.
(e) Compensation.--(1) Members of the Commission shall each
be entitled to receive the daily equivalent of the annual rate
of basic pay in effect for grade GS-18 of the General Schedule
for each day (including travel time) during which they are
engaged in the actual performance of duties vested in the
Commission.
(2) While away from their homes or regular places of
business in the performance of services for the Commission,
members of the Commission shall be allowed travel expenses,
including per diem in lieu of subsistence, in the same manner
as persons employed intermittently in the Government service
are allowed expenses under section 5703 of title 5 of the
United States Code.
duties of the commission
Sec. 1802. [300v-1] (a) Studies.--(1) The Commission shall
undertake studies of the ethical and legal implications of--
(A) the requirements for informed consent to
participation in research projects and to otherwise
undergo medical procedures;
(B) the matter of defining death, including the
advisability of developing a uniform definition of
death;
(C) voluntary testing, counseling, and information
and education programs with respect to genetic diseases
and conditions, taking into account the essential
equality of all human beings, born and unborn;
(D) the differences in the availability of health
services as determined by the income or residence of
the persons receiving the services;
(E) current procedures and mechanisms designed (i)
to safeguard the privacy of human subjects of
behavioral and biomedical research, (ii) to ensure the
confidentiality of individually identifiable patient
records, and (iii) to ensure appropriate access of
patients to information continued \1\ in such records,
\2\ and
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\1\ So in law. Probably should be ``contained''.
\2\ So in law. The comma should probably be a semicolon.
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(F) such other matters relating to medicine or
biomedical or behavioral research as the President may
designate for study by the Commission.
The Commission shall determine the priority and order of the
studies required under this paragraph.
(2) The Commission may undertake an investigation or study
of any other appropriate matter which relates to medicine or
biomedical or behavioral research (including the protection of
human subjects of biomedical or behavioral research) and which
is consistent with the purposes of this title on its own
initiative or at the request of the head of the Federal agency.
(3) In order to avoid duplication of effort, the Commission
may, in lieu of, or as part of, any study or investigation
required or otherwise conducted under this subsection, use a
study or investigation conducted by another entity if the
Commission sets forth its reasons for such use.
(4) Upon the completion of each investigation or study
undertaken by the Commission under this subsection (including a
study or investigation which merely uses another study or
investigation), it shall report its findings (including any
recommendations for legislation or administrative action) to
the President and the Congress and to each Federal agency to
which a recommendation in the report applies.
(b) Recommendations to Agencies.--(1) Within 60 days of the
date a Federal agency receives a recommendation from the
Commission that the agency take any action with respect to its
rules, policies, guidelines, or regulations, the agency shall
publish such recommendation in the Federal Register and shall
provide opportunity for interested persons to submit written
data, views, and arguments with respect to adoption of the
recommendation.
(2) Within the 180-day period beginning on the date of such
publication, the agency shall determine whether the action
proposed by such recommendation is appropriate, and, to the
extent that it determines that--
(A) such action is not appropriate, the agency
shall, within such time period, provide the Commission
with, and publish in the Federal Register, a notice of
such determination (including an adequate statement of
the reasons for the determination), or
(B) such action is appropriate, the agency shall
undertake such action as expeditiously as feasible and
shall notify the Commission of the determination and
the action undertaken.
(c) Report on Protection of Human Subjects.--The Commission
shall biennially report to the President, the Congress, and
appropriate Federal agencies on the protection of human
subjects of biomedical and behavioral research. Each such
report shall include a review of the adequacy and uniformity
(1) of the rules, policies, guidelines, and regulations of all
Federal agencies regarding the protection of human subjects of
biomedical or behavioral research which such agencies conduct
or support, and (2) of the implementation of such rules,
policies, guidelines, and regulations by such agencies, and may
include such recommendations for legislation and administrative
action as the Commission deems appropriate.
(d) Annual Report.--Not later than December 15 of each year
(beginning with 1979) the Commission shall report to the
President, the Congress, and appropriate Federal agencies on
the activities of the Commission during the fiscal year ending
in such year. Each such report shall include a complete list of
all recommendations described in subsection (b)(1) made to
Federal agencies by the Commission during the fiscal year and
the actions taken, pursant \1\ to subsection (b)(2), by the
agencies upon such recommendations, and may include such
recommendations for legislation and administrative action as
the Commission deems appropriate.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``pursuant''.
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(e) Publications.--The Commission may at any time publish
and disseminate to the public reports respecting its
activities.
(f) Definitions.--For purposes of this section:
(1) The term ``Federal agency'' means an authority
of the government of the United States, but does not
include (A) the Congress, (B) the courts of the United
States, and (C) the government of the Commonwealth of
Puerto Rico, the government of the District of
Columbia, or the government of any territory or
possession of the United States.
(2) The term ``protection of human subjects''
includes the protection of the health, safety, and
privacy of individuals.
administrative provisions
Sec. 1803. [300v-2] (a) Hearings.--The Commission may for
the purpose of carrying out this title hold such hearings, sit
and act at such times and places, take such testimony, and
receive such evidence, as the Commission may deem advisable.
(b) Staff.--(1) The Commission may appoint and fix the pay
of such staff personnel as it deems desirable. Such personnel
shall be appointed subject to the provisions of title 5, United
States Code, governing appointments in the competitive service,
and shall be paid in accordance with the provisions of chapter
51 and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates.
(2) The Commission may procure temporary and intermittent
services to the same extent as is authorized by section 3109(b)
of title 5 of the United States Code, but at rates for
individuals not to exceed the daily equivalent of the annual
rate of basis pay in effect for grade GS-18 of the General
Schedule.
(3) Upon request of the Commission, the head of any Federal
agency is authorized to detail, on a reimbursable basis, any of
the personnel of such agency to the Commission to assist it in
carrying out its duties under this title.
(c) Contracts.--The Commission, in performing its duties
and functions under this title, may enter into contracts with
appropriate public or nonprofit private entities. The authority
of the Commission to enter into such contracts is effective for
any fiscal year only to such extent or in such amounts as are
provided in advance in appropriation Acts.
(d) Information.--(1) The Commission may secure directly
from any Federal agency information necessary to enable it to
carry out this title. Upon request of the Chairman of the
Commission, the head of such agency shall furnish such
information to the Commission.
(2) The Commission shall promptly arrange for such security
clearances for its members and appropriate staff as are
necessary to obtain access to classified information needed to
carry out its duties under this title.
(3) The Commission shall not disclose any information
reported to or otherwise obtained by the Commission which is
exempt from disclosure under subsection (a) of section 552 of
title 5, United States Code, by reason of paragraphs (4) and
(6) of subsection (b) of such section.
(e) Support Services.--The Administrator of General
Services shall provide to the Commission on a reimbursable
basis such administrative support services as the Commission
may request.
authorization of appropriations; termination of commission
Sec. 1804. [300v-3] (a) Authorizations.--To carry out this
title there are authorized to be appropriated $5,000,000 for
the fiscal year ending September 30, 1979, $5,000,000 for the
fiscal year ending September 30, 1980, $5,000,000 for the
fiscal year ending September 30, 1981, and $5,000,000 for the
fiscal year ending September 30, 1982.
(b) Federal Advisory Committee Act; Termination.--The
Commission shall be subject to the Federal Advisory Committee
Act, except that, under section 14(a)(1)(B) of such Act, the
Commission shall terminate on December 31,
1982.ATTORNEY: PMG/FD (June 22, 1999) deg.
TITLE XIX--BLOCK GRANTS
H2 deg.Part A--Preventive Health and Health Services Block
Grant
H3 deg.authorization of appropriations
Sec. 1901. [300w] (a) For the purpose of allotments under
section 1902, there are authorized to be appropriated
$205,000,000 for fiscal year 1993, and such sums as may be
necessary for each of the fiscal years 1994 through 1998.
(b) Of the amount appropriated for any fiscal year under
subsection (a), at least $7,000,000 shall be made available for
allotments under section 1902(b).
allotments
Sec. 1902. [300w-1] (a)(1) From the amounts appropriated
under section 1901 for any fiscal year and available for
allotment under this subsection, the Secretary shall allot to
each State an amount which bears the same ratio to the
available amounts for that fiscal year as the amounts provided
by the Secretary under the provisions of law listed in
paragraph (2) to the State and entities in the State for fiscal
year 1981 bore to the total amount appropriated for such
provisions of law for fiscal year 1981.
(2) The provisions of law referred to in paragraph (1) are
the following provisions of law as in effect on September 30,
1981:
(A) The authority for grants under section 317 for
preventive health service programs for the control of
rodents.
(B) The authority for grants under section 317 for
establishing and maintaining community and school-based
fluoridation programs.
(C) The authority for grants under section 317 for
preventive health service programs for hypertension.
(D) Sections 401 and 402 of the Health Services and
Centers Amendments of 1978.
(E) Section 314(d).
(F) Section 339(a).
(G) Sections 1202, 1203, and 1204.
(b) From the amount required to be made available under
section 1901(b) for allotments under this subsection for any
fiscal year, the Secretary shall make allotments to each State
on the basis of the population of the State.
(c) To the extent that all the funds appropriated under
section 1901 for a fiscal year and available for allotment in
such fiscal year are not otherwise allotted to States because--
(1) one or more States have not submitted an
application or description of activities in accordance
with section 1905 for the fiscal year;
(2) one or more States have notified the Secretary
that they do not intend to use the full amount of their
allotment; or
(3) some State allotments are offset or repaid
under section 1906(b)(3);
such excess shall be allotted among each of the remaining
States in proportion to the amount otherwise allotted to such
States for the fiscal year without regard to this subsection.
(d)(1) If the Secretary--
(A) receives a request from the governing body of
an Indian tribe or tribal organization within any State
that funds under this part be provided directly by the
Secretary to such tribe or organization, and
(B) determines that the members of such tribe or
tribal organization would be better served by means of
grants made directly by the Secretary under this part,
the Secretary shall reserve from amounts which would otherwise
be allotted to such State under subsection (a) for the fiscal
year the amount determined under paragraph (2).
(2) The Secretary shall reserve for the purpose of
paragraph (1) from amounts that would otherwise be allotted to
such State under subsection (a) an amount equal to the amount
which bears the same ratio to the State's allotment for the
fiscal year involved as the total amount provided or allotted
for fiscal year 1981 by the Secretary to such tribe or tribal
organization under the provisions of law referred to in
subsection (a) bore to the total amount provided or allotted
for such fiscal year by the Secretary to the State and entities
(including Indian tribes and tribal organizations) in the State
under such provisions of law.
(3) The amount reserved by the Secretary on the basis of a
determination under this subsection shall be granted to the
Indian tribe or tribal organization serving the individuals for
whom such a determination has been made.
(4) In order for an Indian tribe or tribal organization to
be eligible for a grant for a fiscal year under this
subsection, it shall submit to the Secretary a plan for such
fiscal year which meets such criteria as the Secretary may
prescribe.
(5) The terms ``Indian tribe'' and ``tribal organization''
have the same meaning given such terms in section 4(b) and
section 4(c) of the Indian Self-Determination and Education
Assistance Act.
(e) The Secretary shall conduct a study for the purpose of
devising a formula for the equitable distribution of funds
available for allotment to the States under this section. In
conducting the study, the Secretary shall take into account--
(1) the financial resources of the various States,
(2) the populations of the States, and
(3) any other factor which the Secretary may
consider appropriate.
Before June 30, 1982, the Secretary shall submit a report to
the Congress respecting the development of a formula and make
such recommendations as the Secretary may deem appropriate in
order to ensure the most equitable distribution of funds under
allotments under this section.
payments under allotments to states
Sec. 1903. [300w-2] (a)(1) For each fiscal year, the
Secretary shall make payments, as provided by section 203 of
the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213),
to each State from its allotment under section 1902 (other than
any amount reserved under section 1902(d)) from amounts
appropriated for that fiscal year.
(2) Any amount paid to a State for a fiscal year and
remaining unobligated at the end of such year shall remain
available for the next fiscal year to such State for the
purposes for which it was made.
(b) The Secretary, at the request of a State, may reduce
the amount of payments under subsection (a) by--
(1) the fair market value of any supplies or
equipment furnished the State, and
(2) the amount of the pay, allowances, and travel
expenses of any officer or employee of the Government
when detailed to the State and the amount of any other
costs incurred in connection with the detail of such
officer or employee,
when the furnishing of supplies or equipment or the detail of
an officer or employee is for the convenience of and at the
request of the State and for the purpose of conducting
activities described in section 1904. The amount by which any
payment is so reduced shall be available for payment by the
Secretary of the costs incurred in furnishing the supplies or
equipment or in detailing the personnel, on which the reduction
of the payment is based, and the amount shall be deemed to be
part of the payment and shall be deemed to have been paid to
the State.
use of allotments
Sec. 1904. [300w-3] (a)(1) Except as provided in
subsections (b) and (c), payments made to a State under section
1903 may be used for the following:
(A) Activities consistent with making progress
toward achieving the objectives established by the
Secretary for the health status of the population of
the United States for the year 2000 (in this part
referred to as ``year 2000 health objectives'').
(B) Preventive health service programs for the
control of rodents and for community and school-based
fluoridation programs.
(C) Feasibility studies and planning for emergency
medical services systems and the establishment,
expansion, and improvement of such systems. Amounts for
such systems may not be used for the costs of the
operation of the systems or the purchase of equipment
for the systems, except that such amounts may be used
for the payment of not more than 50 percent of the
costs of purchasing communications equipment for the
systems. Amounts may be expended for feasibility
studies or planning for the trauma-care components of
such systems only if the studies or planning,
respectively, is consistent with the requirements of
section 1213(a).
(D) Providing services to victims of sex offenses
and for prevention of sex offenses.
(E) The establishment, operation, and coordination
of effective and cost-efficient systems to reduce the
prevalence of illness due to asthma and asthma-related
illnesses, especially among children, by reducing the
level of exposure to cockroach allergen or other known
asthma triggers through the use of integrated pest
management, as applied to cockroaches or other known
allergens. Amounts expended for such systems may
include the costs of building maintenance and the costs
of programs to promote community participation in the
carrying out at such sites of integrated pest
management, as applied to cockroaches or other known
allergens. For purposes of this subparagraph, the term
``integrated pest management'' means an approach to the
management of pests in public facilities that combines
biological, cultural, physical, and chemical tools in a
way that minimizes economic, health, and environmental
risks.
(F) With respect to activities described in any of
subparagraphs (A) through (E), related planning,
administration, and educational activities.
(G) Monitoring and evaluation of activities carried
out under any of subparagraphs (A) through (F).
(2) Except as provided in subsection (b), amounts paid to a
State under section 1903 from its allotment under section
1902(b) may only be used for providing services to rape victims
and for rape prevention.
(3) The Secretary may provide technical assistance to
States in planning and operating activities to be carried out
under this part.
(b) A State may not use amounts paid to it under section
1903 to--
(1) provide inpatient services,
(2) make cash payments to intended recipients of
health services,
(3) purchase or improve land, purchase, construct,
or permanently improve (other than minor remodeling)
any building or other facility, or purchase major
medical equipment,
(4) satisfy any requirement for the expenditure of
non-Federal funds as a condition for the receipt of
Federal funds, or
(5) provide financial assistance to any entity
other than a public or nonprofit private entity.
Except as provided in subsection (a)(1)(E), the Secretary may
waive the limitation contained in paragraph (3) upon the
request of a State if the Secretary finds that there are
extraordinary circumstances to justify the waiver and that
granting the waiver will assist in carrying out this part.
(c) A State may transfer not more than 7 percent of the
amount allotted to the State under section 1902(a) for any
fiscal year for use by the State under part B of this title and
title V of the Social Security Act in such fiscal year as
follows: At any time in the first three quarters of the fiscal
year a State may transfer not more than 3 percent of the
allotment of the State for the fiscal year for such use, and in
the last quarter of a fiscal year a State may transfer for such
use not more than the remainder of the amount of its allotment
which may be transferred.
(d) Of the amount paid to any State under section 1903, not
more than 10 percent paid from each of its allotments under
subsections (a) and (b) of section 1902 may be used for
administering the funds made available under section 1903. The
State will pay from non-Federal sources the remaining costs of
administering such funds.
application for payments; state plan
Sec. 1905. [300w-4] (a) In General.--The Secretary may make
payments under section 1903 to a State for a fiscal year only
if--
(1) the State submits to the Secretary an
application for the payments;
(2) the application contains a State plan in
accordance with subsection (b);
(3) the application contains the certification
described in subsection (c);
(4) the application contains such assurances as the
Secretary may require regarding the compliance of the
State with the requirements of this part (including
assurances regarding compliance with the agreements
described in subsection (c)); and
(5) the application is in such form and is
submitted by such date as the Secretary may require.
(b) State Plan.--A State plan required in subsection (a)(2)
for a fiscal year is in accordance with this subsection if the
plan meets the following conditions:
(1) The plan is developed by the State agency with
principal responsibility for public health programs, in
consultation with the advisory committee established
pursuant to subsection (c)(2).
(2) The plan specifies the activities authorized in
section 1904 that are to be carried out with payments
made to the State under section 1903, including a
specification of the year 2000 health objectives for
which the State will expend the payments.
(3) The plan specifies the populations in the State
for which such activities are to be carried out.
(4) The plan specifies any populations in the State
that have a disparate need for such activities.
(5) With respect to each population specified under
paragraph (3), the plan contains a strategy for
expending such payments to carry out such activities to
make progress toward improving the health status of the
population, which strategy includes--
(A) a description of the programs and
projects to be carried out;
(B) an estimate of the number of
individuals to be served by the programs and
projects; and
(C) an estimate of the number of public
health personnel needed to carry out the
strategy.
(6) The plan specifies the amount of such payments
to be expended for each of such activities and, with
respect to the activity involved--
(A) the amount to be expended for each
population specified under paragraph (3); and
(B) the amount to be expended for each
population specified under paragraph (4).
(c) State Certification.--The certification referred to in
subsection (a)(3) for a fiscal year is a certification to the
Secretary by the chief executive officer of the State involved
as follows:
(1)(A) In the development of the State plan
required in subsection (a)(2)--
(i) the chief health officer of the State
held public hearings on the plan; and
(ii) proposals for the plan were made
public in a manner that facilitated comments
from public and private entities (including
Federal and other public agencies).
(B) The State agrees that, if any revisions are
made in such plan during the fiscal year, the State
will, with respect to the revisions, hold hearings and
make proposals public in accordance with subparagraph
(A), and will submit to the Secretary a description of
the revisions.
(2) The State has established an advisory committee
in accordance with subsection (d).
(3) The State agrees to expend payments under
section 1903 only for the activities authorized in
section 1904.
(4) The State agrees to expend such payments in
accordance with the State plan submitted under
subsection (a)(2) (with any revisions submitted to the
Secretary under paragraph (1)(B)), including making
expenditures to carry out the strategy contained in the
plan pursuant to subsection (b)(5).
(5)(A) The State agrees that, in the case of each
population for which such strategy is carried out, the
State will measure the extent of progress being made
toward improving the health status of the population.
(B) The State agrees that--
(i) the State will collect and report data
in accordance with section 1906(a); and
(ii) for purposes of subparagraph (A),
progress will be measured through use of each
of the applicable uniform data items developed
by the Secretary under paragraph (2) of such
section, or if no such items are applicable,
through use of the uniform criteria developed
by the Secretary under paragraph (3) of such
section.
(6) With respect to the activities authorized in
section 1904, the State agrees to maintain State
expenditures for such activities at a level that is not
less than the average level of such expenditures
maintained by the State for the 2-year period preceding
the fiscal year for which the State is applying to
receive payments under section 1903.
(7) The State agrees to establish reasonable
criteria to evaluate the effective performance of
entities that receive funds from such payments and
procedures for procedural and substantive independent
State review of the failure by the State to provide
funds for any such entity.
(8) The State agrees to permit and cooperate with
Federal investigations undertaken in accordance with
section 1907.
(9) The State has in effect a system to protect
from inappropriate disclosure patient and sex offense
victim records maintained by the State in connection
with an activity funded under this part or by any
entity which is receiving payments from the allotment
of the State under this part.
(10) The State agrees to provide the officer of the
State government responsible for the administration of
the State highway safety program with an opportunity
to--
(A) participate in the development of any
plan by the State relating to emergency medical
services, as such plan relates to highway
safety; and
(B) review and comment on any proposal by
any State agency to use any Federal grant or
Federal payment received by the State for the
provision of emergency medical services as such
proposal relates to highway safety.
(d) State Advisory Committee.--
(1) In general.--For purposes of subsection (c)(2),
an advisory committee is in accordance with this
subsection if such committee is known as the State
Preventive Health Advisory Committee (in this
subsection referred to as the ``Committee'') and the
Committee meets the conditions described in the
subsequent paragraphs of this subsection.
(2) Duties.--A condition under paragraph (1) for a
State is that the duties of the Committee are--
(A) to hold public hearings on the State
plan required in subsection (a)(2); and
(B) to make recommendations pursuant to
subsection (b)(1) regarding the development and
implementation of such plan, including
recommendations on--
(i) the conduct of assessments of
the public health;
(ii) which of the activities
authorized in section 1904 should be
carried out in the State;
(iii) the allocation of payments
made to the State under section 1903;
(iv) the coordination of activities
carried out under such plan with
relevant programs of other entities;
and
(v) the collection and reporting of
data in accordance with section
1906(a).
(3) Composition.--
(A) A condition under paragraph (1) for a
State is that the Committee is composed of such
members of the general public, and such
officials of the health departments of
political subdivisions of the State, as may be
necessary to provide adequate representation of
the general public and of such health
departments.
(B) With respect to compliance with
subparagraph (A), the membership of advisory
committees established pursuant to subsection
(c)(2) may include representatives of
community-based organizations (including
minority community-based organizations),
schools of public health, and entities to which
the State involved awards grants or contracts
to carry out activities authorized in section
1904.
(4) Chair; meetings.--A condition under paragraph
(1) for a State is that the State public health officer
serves as the chair of the Committee, and that the
Committee meets not less than twice each fiscal year.
reports, data, and audits
Sec. 1906. [300w-5] (a)(1) For purposes of section
1905(c)(5)(B)(i), a State is collecting and reporting data for
a fiscal year in accordance with this subsection if the State
submits to the Secretary, not later than February 1 of the
succeeding fiscal year, a report that--
(A) describes the purposes for which the State
expended payments made to the State under section 1903;
(B) pursuant to section 1905(c)(5)(A), describes
the extent of progress made by the State for purposes
of such section;
(C) meets the conditions described in the
subsequent paragraphs of this subsection; and
(D) contains such additional information regarding
activities authorized in section 1904, and is submitted
in such form, as the Secretary may require.
(2)(A) The Secretary, in consultation with the States,
shall develop sets of data for uniformly defining health status
for purposes of the year 2000 health objectives (which sets are
in this subsection referred to as ``uniform data sets''). Each
of such sets shall consist of one or more categories of
information (in this subsection individually referred to as a
``uniform data item''). The Secretary shall develop formats for
the uniform collecting and reporting of information on such
items.
(B) A condition under paragraph (1)(C) for a fiscal year is
that the State involved will, in accordance with the applicable
format under subparagraph (A), collect during such year, and
include in the report under paragraph (1), the necessary
information for one uniform data item from each of the uniform
data sets, which items are selected for the State by the
Secretary.
(C) In the case of fiscal year 1995 and each subsequent
fiscal year, a condition under paragraph (1) for a State is
that the State will, in accordance with the applicable format
under subparagraph (A), collect during such year, and include
in the report under paragraph (1), the necessary information
for each of the uniform data sets appropriate to the year 2000
health objectives that the State has, in the State plan
submitted under section 1905 for the fiscal year, specified as
a purpose for which payments under section 1903 are to be
expended.
(3) The Secretary, in consultation with the States, shall
establish criteria for the uniform collection and reporting of
data on activities authorized in section 1904 with respect to
which no uniform data items exist.
(4) A condition under paragraph (1) for a fiscal year is
that the State involved will make copies of the report
submitted under such paragraph for the fiscal year available
for public inspection, and will upon request provide a copy of
the report to any individual for a charge not exceeding the
cost of providing the copy.
(b)(1) Each State shall establish fiscal control and fund
accounting procedures as may be necessary to assure the proper
disbursal of and accounting for Federal funds paid to the State
under section 1903 and funds transferred under section 1904(c)
for use under this part.
(2) Each State shall annually audit its expenditures from
payments received under section 1903. Such State audits shall
be conducted by an entity independent of any agency
administering a program funded under this part and, in so far
as practical, in accordance with the Comptroller General's
standards for auditing governmental organizations, programs,
activities, and functions. Within 30 days following the date
each audit is completed, the chief executive officer of the
State shall transmit a copy of that audit to the Secretary.
(3) Each State shall, after being provided by the Secretary
with adequate notice and opportunity for a hearing within the
State, repay to the United States amounts found not to have
been expended in accordance with the requirements of this part
or the certification provided by the State under section 1905.
If such repayment is not made, the Secretary shall, after
providing the State with adequate notice and opportunity for a
hearing within the State, offset such amounts against the
amount of any allotment to which the State is or may become
entitled under this part.
(4) The State shall make copies of the reports and audits
required by this section available for public inspection within
the State.
(5) The Comptroller General of the United States shall,
from time to time, evaluate the expenditures by States of
grants under this part in order to assure that expenditures are
consistent with the provisions of this part and the
certification provided by the State under section 1905.
(6) Not later than October 1, 1990, the Secretary shall
report to the Congress on the activities of the States that
have received funds under this part and may include in the
report any recommendations for appropriate changes in
legislation.
(c) Title XVII of the Omnibus Budget Reconciliation Act of
1981 shall not apply with respect to audits of funds allotted
under this part.
withholding
Sec. 1907. [300w-6] (a)(1) The Secretary shall, after
adequate notice and an opportunity for a hearing conducted
within the affected State, withhold funds from any State which
does not use its allotment in accordance with the requirements
of this part or the certification provided under section 1905.
The Secretary shall withhold such funds until the Secretary
finds that the reason for the withholding has been removed and
there is reasonable assurance that it will not recur.
(2) The Secretary may not institute proceedings to withhold
funds under paragraph (1) unless the Secretary has conducted an
investigation concerning whether the State has used its
allotment in accordance with the requirements of this part or
the certification provided under section 1905. Investigations
required by this paragraph shall be conducted within the
affected State by qualified investigators.
(3) The Secretary shall respond in an expeditious manner to
complaints of a substantial or serious nature that a State has
failed to use funds in accordance with the requirements of this
part or certifications provided under section 1905.
(4) The Secretary may not withhold funds under paragraph
(1) from a State for a minor failure to comply with the
requirements of this part or certifications provided under
section 1905.
(b)(1) The Secretary shall conduct in several States in
each fiscal year investigations of the use of funds received by
the States under this part in order to evaluate compliance with
the requirements of this part and certifications provided under
section 1905.
(2) The Comptroller General of the United States may
conduct investigations of the use of funds received under this
part by a State in order to insure compliance with the
requirements of this part and certifications provided under
section 1905.
(c) Each State, and each entity which has received funds
from an allotment made to a State under this part, shall make
appropriate books, documents, papers, and records available to
the Secretary or the Comptroller General of the United States,
or any of their duly authorized representatives, for
examination, copying, or mechanical reproduction on or off the
premises of the appropriate entity upon a reasonable request
therefor.
(d)(1) In conducting any investigation in a State, the
Secretary or the Comptroller General of the United States may
not make a request for any information not readily available to
such State or an entity which has received funds from an
allotment made to the State under this part or make an
unreasonable request for information to be compiled, collected,
or transmitted in any form not readily available.
(2) Paragraph (1) does not apply to the collection,
compilation, or transmittal of data in the course of a judicial
proceeding.
nondiscrimination
Sec. 1908. [300w-7] (a)(1) For the purpose of applying the
prohibitions against discrimination on the basis of age under
the Age Discrimination Act of 1975, on the basis of handicap
under section 504 of the Rehabilitation Act of 1973, on the
basis of sex under title IX of the Education Amendments of
1972, or on the basis of race, color, or national origin under
title VI of the Civil Rights Act of 1964, programs and
activities funded in whole or in part with funds made available
under this part are considered to be programs and activities
receiving Federal financial assistance.
(2) No person shall on the ground of sex or religion be
excluded from participation in, be denied the benefits of, or
be subjected to discrimination under, any program or activity
funded in whole or in part with funds made available under this
part.
(b) Whenever the Secretary finds that a State, or an entity
that has received a payment from an allotment to a State under
section 1902, has failed to comply with a provision of law
referred to in subsection (a)(1), with subsection (a)(2), or
with an applicable regulation (including one prescribed to
carry out subsection (a)(2)), the Secretary shall notify the
chief executive officer of the State and shall request him to
secure compliance. If within a reasonable period of time, not
to exceed sixty days, the chief executive officer fails or
refuses to secure compliance, the Secretary may--
(1) refer the matter to the Attorney General with a
recommendation that an appropriate civil action be
instituted,
(2) exercise the powers and functions provided by
title VI of the Civil Rights Act of 1964, the Age
Discrimination Act of 1975, or section 504 of the
Rehabilitation Act of 1973, as may be applicable, or
(3) take such other action as may be provided by
law.
(c) When a matter is referred to the Attorney General
pursuant to subsection (b)(1), or whenever he has reason to
believe that a State or an entity is engaged in a pattern or
practice in violation of a provision of law referred to in
subsection (a)(1) or in violation of subsection (a)(2), the
Attorney General may bring a civil action in any appropriate
district court of the United States for such relief as may be
appropriate, including injunctive relief.
criminal penalty for false statements
Sec. 1909. [300w-8] Whoever--
(1) knowingly and willfully makes or causes to be
made any false statement or representation of a
material fact in connection with the furnishing of
items or services for which payment may be made by a
State from funds allotted to the State under this part,
or
(2) having knowledge of the occurrence of any event
affecting his initial or continued right to any such
payment conceals or fails to disclose such event with
an intent fraudulently to secure such payment either in
a greater amount than is due or when no such payment is
authorized,
shall be fined not more than $25,000 or imprisoned for not more
than five years, or both.
emergency medical services for children
Sec. 1910. [300w-9] (a) For activities in addition to the
activities which may be carried out by States under section
1904(a)(1)(F), the Secretary may make grants to States or
accredited schools of medicine in States to support a program
of demonstration projects for the expansion and improvement of
emergency medical services for children who need treatment for
trauma or critical care. Any grant made under this subsection
shall be for not more than a 4-year period (with an optional
5th year based on performance), subject to annual evaluation by
the Secretary. Only 3 grants under this subsection may be made
in a State (to a State or to a school of medicine in such
State) in any fiscal year.
(b) The Secretary may renew a grant made under subsection
(a) for one additional one-year period only if the Secretary
determines that renewal of such grant will provide significant
benefits through the collection, analysis, and dissemination of
information or data which will be useful to States in which
grants under such subsection have not been made.
(c) For purposes of this section--
(1) the term ``school of medicine'' has the same
meaning as in section 701(4); and
(2) the term ``accredited'' has the same meaning as
in section 701(5).
(d) To carry out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 1985 and for each of
the two succeeding fiscal years, $3,000,000 for fiscal year
1989, $4,000,000 for fiscal year 1990, $5,000,000 for each of
the fiscal years 1991 and 1992, such sums as may be necessary
for each of the fiscal years 1993 through 2005, $25,000,000 for
fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
for fiscal year 2012, $28,940,625 for fiscal year 2013, and
$30,387,656 for fiscal year 2014.
Part B--Block Grants Regarding Mental Health and Substance Abuse
Subpart I--Block Grants for Community Mental Health Services
H4 deg.SEC. 1911. [300X] FORMULA GRANTS TO STATES.
(a) In General.--For the purpose described in subsection
(b), the Secretary, acting through the Director of the Center
for Mental Health Services, shall make an allotment each fiscal
year for each State in an amount determined in accordance with
section 1918. The Secretary shall make a grant to the State of
the allotment made for the State for the fiscal year if the
State submits to the Secretary an application in accordance
with section 1917.
(b) Purpose of Grants.--A funding agreement for a grant
under subsection (a) is that, subject to section 1916, the
State involved will expend the grant only for the purpose of--
(1) carrying out the plan submitted under section
1912(a) by the State for the fiscal year involved;
(2) evaluating programs and services carried out
under the plan; and
(3) planning, administration, and educational
activities related to providing services under the
plan.
H4 deg.SEC. 1912. [300X-1] STATE PLAN FOR COMPREHENSIVE
COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN
INDIVIDUALS.
(a) In General.--The Secretary may make a grant under
section 1911 only if--
(1) the State involved submits to the Secretary a
plan for providing comprehensive community mental
health services to adults with a serious mental illness
and to children with a serious emotional disturbance;
(2) the plan meets the criteria specified in
subsection (b); and
(3) the plan is approved by the Secretary.
(b) Criteria for Plan.--With respect to the provision of
comprehensive community mental health services to individuals
who are either adults with a serious mental illness or children
with a serious emotional disturbance, the criteria referred to
in subsection (a) regarding a plan are as follows:
(1) Comprehensive community-based mental health
systems.--The plan provides for an organized community-
based system of care for individuals with mental
illness and describes available services and resources
in a comprehensive system of care, including services
for dually diagnosed individuals. The description of
the system of care shall include health and mental
health services, rehabilitation services, employment
services, housing services, educational services,
substance abuse services, medical and dental care, and
other support services to be provided to individuals
with Federal, State and local public and private
resources to enable such individuals to function
outside of inpatient or residential institutions to the
maximum extent of their capabilities, including
services to be provided by local school systems under
the Individuals with Disabilities Education Act. The
plan shall include a separate description of case
management services and provide for activities leading
to reduction of hospitalization.
(2) Mental health system data and epidemiology.--
The plan contains an estimate of the incidence and
prevalence in the State of serious mental illness among
adults and serious emotional disturbance among children
and presents quantitative targets to be achieved in the
implementation of the system described in paragraph
(1).
(3) Children's services.--In the case of children
with serious emotional disturbance, the plan--
(A) subject to subparagraph (B), provides
for a system of integrated social services,
educational services, juvenile services, and
substance abuse services that, together with
health and mental health services, will be
provided in order for such children to receive
care appropriate for their multiple needs (such
system to include services provided under the
Individuals with Disabilities Education Act);
(B) provides that the grant under section
1911 for the fiscal year involved will not be
expended to provide any service under such
system other than comprehensive community
mental health services; and
(C) provides for the establishment of a
defined geographic area for the provision of
the services of such system.
(4) Targeted services to rural and homeless
populations.--The plan describes the State's outreach
to and services for individuals who are homeless and
how community-based services will be provided to
individuals residing in rural areas.
(5) Management systems.--The plan describes the
financial resources, staffing and training for mental
health providers that is necessary to implement the
plan, and provides for the training of providers of
emergency health services regarding mental health. The
plan further describes the manner in which the State
intends to expend the grant under section 1911 for the
fiscal year involved.
Except as provided for in paragraph (3), the State plan shall
contain the information required under this subsection with
respect to both adults with serious mental illness and children
with serious emotional disturbance.
(c) Definitions Regarding Mental Illness and Emotional
Disturbance; Methods for Estimate of Incidence and
Prevalence.--
(1) Establishment by secretary of definitions;
dissemination.--For purposes of this subpart, the
Secretary shall establish definitions for the terms
``adults with a serious mental illness'' and ``children
with a serious emotional disturbance''. The Secretary
shall disseminate the definitions to the States.
(2) Standardized methods.--The Secretary shall
establish standardized methods for making the estimates
required in subsection (b)(11) with respect to a State.
A funding agreement for a grant under section 1911 for
the State is that the State will utilize such methods
in making the estimates.
(3) Date certain for compliance by secretary.--Not
later than 90 days after the date of the enactment of
the ADAMHA Reorganization Act \1\, the Secretary shall
establish the definitions described in paragraph (1),
shall begin dissemination of the definitions to the
States, and shall establish the standardized methods
described in paragraph (2).
---------------------------------------------------------------------------
\1\ Enacted July 10, 1992.
---------------------------------------------------------------------------
(d) Requirement of Implementation of Plan.--
(1) Complete implementation.--Except as provided in
paragraph (2), in making a grant under section 1911 to
a State for a fiscal year, the Secretary shall make a
determination of the extent to which the State has
implemented the plan required in subsection (a). If the
Secretary determines that a State has not completely
implemented the plan, the Secretary shall reduce the
amount of the allotment under section 1911 for the
State for the fiscal year involved by an amount equal
to 10 percent of the amount determined under section
1918 for the State for the fiscal year.
(2) Substantial implementation and good faith
effort regarding fiscal year 1993.--
(A) In making a grant under section 1911 to
a State for fiscal year 1993, the Secretary
shall make a determination of the extent to
which the State has implemented the plan
required in subsection (a). If the Secretary
determines that the State has not substantially
implemented the plan, the Secretary shall,
subject to subparagraph (B), reduce the amount
of the allotment under section 1911 for the
State for such fiscal year by an amount equal
to 10 percent of the amount determined under
section 1918 for the State for the fiscal year.
(B) In carrying out subparagraph (A), if
the Secretary determines that the State is
making a good faith effort to implement the
plan required in subsection (a), the Secretary
may make a reduction under such subparagraph in
an amount that is less than the amount
specified in such subparagraph, except that the
reduction may not be made in an amount that is
less than 5 percent of the amount determined
under section 1918 for the State for fiscal
year 1993.
SEC. 1913. [300X-2] CERTAIN AGREEMENTS.
(a) Allocation for Systems of Integrated Services for
Children.--
(1) In general.--With respect to children with a
serious emotional disturbance, a funding agreement for
a grant under section 1911 is that--
(A) in the case of a grant for fiscal year
1993, the State involved will expend not less
than 10 percent of the grant to increase
(relative to fiscal year 1992) funding for the
system of integrated services described in
section 1912(b)(9);
(B) in the case of a grant for fiscal year
1994, the State will expend not less than 10
percent of the grant to increase (relative to
fiscal year 1993) funding for such system; and
(C) in the case of a grant for any
subsequent fiscal year, the State will expend
for such system not less than an amount equal
to the amount expended by the State for fiscal
year 1994.
(2) Waiver.--
(A) Upon the request of a State, the
Secretary may provide to the State a waiver of
all or part of the requirement established in
paragraph (1) if the Secretary determines that
the State is providing an adequate level of
comprehensive community mental health services
for children with a serious emotional
distrubance \1\, as indicated by a comparison
of the number of such children for which such
services are sought with the availability in
the State of the services.
---------------------------------------------------------------------------
\1\ So in law. See section 201 of Public Law 102-321 (106 Stat.
381). Probably should be ``disturbance''.
---------------------------------------------------------------------------
(B) The Secretary shall approve or deny a
request for a waiver under subparagraph (A) not
later than 120 days after the date on which the
request is made.
(C) Any waiver provided by the Secretary
under subparagraph (A) shall be applicable only
to the fiscal year involved.
(b) Providers of Services.--A funding agreement for a grant
under section 1911 for a State is that, with respect to the
plan submitted under section 1912(a) for the fiscal year
involved--
(1) services under the plan will be provided only
through appropriate, qualified community programs
(which may include community mental health centers,
child mental-health programs, psychosocial
rehabilitation programs, mental health peer-support
programs, and mental-health primary consumer-directed
programs); and
(2) services under the plan will be provided
through community mental health centers only if the
centers meet the criteria specified in subsection (c).
(c) Criteria for Mental Health Centers.--The criteria
referred to in subsection (b)(2) regarding community mental
health centers are as follows:
(1) With respect to mental health services, the
centers provide services as follows:
(A) Services principally to individuals
residing in a defined geographic area
(hereafter in this subsection referred to as a
``service area'').
(B) Outpatient services, including
specialized outpatient services for children,
the elderly, individuals with a serious mental
illness, and residents of the service areas of
the centers who have been discharged from
inpatient treatment at a mental health
facility.
(C) 24-hour-a-day emergency care services.
(D) Day treatment or other partial
hospitalization services, or psychosocial
rehabilitation services.
(E) Screening for patients being considered
for admission to State mental health facilities
to determine the appropriateness of such
admission.
(2) The mental health services of the centers are
provided, within the limits of the capacities of the
centers, to any individual residing or employed in the
service area of the center regardless of ability to pay
for such services.
(3) The mental health services of the centers are
available and accessible promptly, as appropriate and
in a manner which preserves human dignity and assures
continuity and high quality care.
H4 deg.SEC. 1914. [300X-3] STATE MENTAL HEALTH PLANNING
COUNCIL.
(a) In General.--A funding agreement for a grant under
section 1911 is that the State involved will establish and
maintain a State mental health planning council in accordance
with the conditions described in this section.
(b) Duties.--A condition under subsection (a) for a Council
is that the duties of the Council are--
(1) to review plans provided to the Council
pursuant to section 1915(a) by the State involved and
to submit to the State any recommendations of the
Council for modifications to the plans;
(2) to serve as an advocate for adults with a
serious mental illness, children with a severe
emotional disturbance, and other individuals with
mental illnesses or emotional problems; and
(3) to monitor, review, and evaluate, not less than
once each year, the allocation and adequacy of mental
health services within the State.
(c) Membership.--
(1) In general.--A condition under subsection (a)
for a Council is that the Council be composed of
residents of the State, including representatives of--
(A) the principal State agencies with
respect to--
(i) mental health, education,
vocational rehabilitation, criminal
justice, housing, and social services;
and
(ii) the development of the plan
submitted pursuant to title XIX of the
Social Security Act;
(B) public and private entities concerned
with the need, planning, operation, funding,
and use of mental health services and related
support services;
(C) adults with serious mental illnesses
who are receiving (or have received) mental
health services; and
(D) the families of such adults or families
of children with emotional disturbance.
(2) Certain requirements.--A condition under
subsection (a) for a Council is that--
(A) with respect to the membership of the
Council, the ratio of parents of children with
a serious emotional disturbance to other
members of the Council is sufficient to provide
adequate representation of such children in the
deliberations of the Council; and
(B) not less than 50 percent of the members
of the Council are individuals who are not
State employees or providers of mental health
services.
(d) Definition.--For purposes of this section, the term
``Council'' means a State mental health planning council.
SEC. 1915. [300X-4] ADDITIONAL PROVISIONS.
(a) Review of State Plan by Mental Health Planning
Council.--The Secretary may make a grant under section 1911 to
a State only if--
(1) the plan submitted under section 1912(a) with
respect to the grant and the report of the State under
section 1942(a) concerning the preceding fiscal year
has been reviewed by the State mental health planning
council under section 1914; and
(2) the State submits to the Secretary any
recommendations received by the State from such council
for modifications to the plan (without regard to
whether the State has made the recommended
modifications) and any comments concerning the annual
report.
(b) Maintenance of Effort Regarding State Expenditures for
Mental Health.--
(1) In general.--A funding agreement for a grant
under section 1911 is that the State involved will
maintain State expenditures for community mental health
services at a level that is not less than the average
level of such expenditures maintained by the State for
the 2-year period preceding the fiscal year for which
the State is applying for the grant.
(2) Exclusion of certain funds.--The Secretary may
exclude from the aggregate State expenditures under
subsection (a), funds appropriated to the principle
agency for authorized activities which are of a non-
recurring nature and for a specific purpose.
(3) Waiver.--The Secretary may, upon the request of
a State, waive the requirement established in paragraph
(1) if the Secretary determines that extraordinary
economic conditions in the State justify the waiver.
(4) Noncompliance by State.--
(A) In making a grant under section 1911 to
a State for a fiscal year, the Secretary shall
make a determination of whether, for the
previous fiscal year, the State maintained
material compliance with the agreement made
under paragraph (1). If the Secretary
determines that a State has failed to maintain
such compliance, the Secretary shall reduce the
amount of the allotment under section 1911 for
the State for the fiscal year for which the
grant is being made by an amount equal to the
amount constituting such failure for the
previous fiscal year.
(B) The Secretary may make a grant under
section 1911 for a fiscal year only if the
State involved submits to the Secretary
information sufficient for the Secretary to
make the determination required in subparagraph
(A).
SEC. 1916. [300X-5] RESTRICTIONS ON USE OF PAYMENTS.
(a) In General.--A funding agreement for a grant under
section 1911 is that the State involved will not expend the
grant--
(1) to provide inpatient services;
(2) to make cash payments to intended recipients of
health services;
(3) to purchase or improve land, purchase,
construct, or permanently improve (other than minor
remodeling) any building or other facility, or purchase
major medical equipment;
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds; or
(5) to provide financial assistance to any entity
other than a public or nonprofit private entity.
(b) Limitation on Administrative Expenses.--A funding
agreement for a grant under section 1911 is that the State
involved will not expend more than 5 percent of the grant for
administrative expenses with respect to the grant.
H4 deg.SEC. 1917. [300X-6] APPLICATION FOR GRANT.
(a) In General.--For purposes of section 1911, an
application for a grant under such section for a fiscal year in
accordance with \1\ this section if, subject to subsection
(b)--
---------------------------------------------------------------------------
\1\ So in law. See section 201 of Public Law 102-321 (106 Stat.
384). Probably should be ``is in accordance with''.
---------------------------------------------------------------------------
(1) the plan is received by the Secretary not later
than September 1 of the fiscal year prior to the fiscal
year for which a State is seeking funds, and the report
from the previous fiscal year as required under section
1941 is received by December 1 of the fiscal year of
the grant;
(2) the application contains each funding agreement
that is described in this subpart or subpart III for
such a grant (other than any such agreement that is not
applicable to the State);
(3) the agreements are made through certification
from the chief executive officer of the State;
(4) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary;
(5) the application contains the plan required in
section 1912(a), the information required in section
1915(b)(3)(B), and the report required in section
1942(a);
(6) the application contains recommendations in
compliance with section 1915(a), or if no such
recommendations are received by the State, the
application otherwise demonstrates compliance with such
section; and
(7) the application (including the plan under
section 1912(a)) is otherwise in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this subpart.
(b) Waivers Regarding Certain Territories.--In the case of
any territory of the United States except Puerto Rico, the
Secretary may waive such provisions of this subpart and subpart
III as the Secretary determines to be appropriate, other than
the provisions of section 1916.
SEC. 1918. [300X-7] DETERMINATION OF AMOUNT OF ALLOTMENT.
(a) States.--
(1) Determination under formula.--Subject to
subsection (b), the Secretary shall determine the
amount of the allotment required in section 1911 for a
State for a fiscal year in accordance with the
following formula:
X
A <3-ln (> ---- <3-ln )>
U
----------------------------------------------------------------------------------------------------------------
(2) Determination of term ``a''.--For purposes of
paragraph (1), the term ``A'' means the difference
between--
(A) the amount appropriated under section
1920(a) for allotments under section 1911 for
the fiscal year involved; and
(B) an amount equal to 1.5 percent of the
amount referred to in subparagraph (A).
(3) Determination of term ``u''.--For purposes of
paragraph (1), the term ``U'' means the sum of the
respective terms ``X'' determined for the States under
paragraph (4).
(4) Determination of term ``x''.--For purposes of
paragraph (1), the term ``X'' means the product of--
(A) an amount equal to the product of--
(i) the term ``P'', as determined
for the State involved under paragraph
(5); and
(ii) the factor determined under
paragraph (8) for the State; and
(B) the greater of--
(i) 0.4; and
(ii) an amount equal to an amount
determined for the State in accordance
with the following formula:
R%
1-.35 <3-ln (> ------- <3-ln )>
P%
----------------------------------------------------------------------------------------------------------------
(5) Determination of term ``p''.--
(A) For purposes of paragraph (4), the term
``P'' means the sum of--
(i) an amount equal to the product
of 0.107 and the number of individuals
in the State who are between 18 and 24
years of age (inclusive);
(ii) an amount equal to the product
of 0.166 and the number of individuals
in the State who are between 25 and 44
years of age (inclusive);
(iii) an amount equal to the
product of 0.099 and the number of
individuals in the State who are
between 45 and 64 years of age
(inclusive); and
(iv) an amount equal to the product
of 0.082 and the number of individuals
in the State who are 65 years of age or
older.
(B) With respect to data on population that
is necessary for purposes of making a
determination under subparagraph (A), the
Secretary shall use the most recent data that
is available from the Secretary of Commerce
pursuant to the decennial census and pursuant
to reasonable estimates by such Secretary of
changes occurring in the data in the ensuing
period.
(6) Determination of term ``r%''.--
(A) For purposes of paragraph (4), the term
``R%'', except as provided in subparagraph (D),
means the percentage constituted by the ratio
of the amount determined under subparagraph (B)
for the State involved to the amount determined
under subparagraph (C).
(B) The amount determined under this
subparagraph for the State involved is the
quotient of--
(i) the most recent 3-year
arithmetic mean of the total taxable
resources of the State, as determined
by the Secretary of the Treasury;
divided by
(ii) the factor determined under
paragraph (8) for the State.
(C) The amount determined under this
subparagraph is the sum of the respective
amounts determined for the States under
subparagraph (B) (including the District of
Columbia).
(D)(i) In the case of the District of
Columbia, for purposes of paragraph (4), the
term ``R%'' means the percentage constituted by
the ratio of the amount determined under clause
(ii) for such District to the amount determined
under clause (iii).
(ii) The amount determined under this
clause for the District of Columbia is the
quotient of--
(I) the most recent 3-year
arithmetic mean of total personal
income in such District, as determined
by the Secretary of Commerce; divided
by
(II) the factor determined under
paragraph (8) for the District.
(iii) The amount determined under this
clause is the sum of the respective amounts
determined for the States (including the
District of Columbia) by making, for each
State, the same determination as is described
in clause (ii) for the District of Columbia.
(7) Determination of term ``p%''.--For purposes of
paragraph (4), the term ``P%'' means the percentage
constituted by the ratio of the term ``P'' determined
under paragraph (5) for the State involved to the sum
of the respective terms ``P'' determined for the
States.
(8) Determination of certain factor.--
(A) The factor determined under this
paragraph for the State involved is a factor
whose purpose is to adjust the amount
determined under clause (i) of paragraph
(4)(A), and the amounts determined under each
of subparagraphs (B)(i) and (D)(ii)(I) of
paragraph (6), to reflect the differences that
exist between the State and other States in the
costs of providing comprehensive community
mental health services to adults with a serious
mental illness and to children with a serious
emotional disturbance.
(B) Subject to subparagraph (C), the factor
determined under this paragraph and in effect
for the fiscal year involved shall be
determined according to the methodology
described in the report entitled ``Adjusting
the Alcohol, Drug Abuse and Mental Health
Services Block Grant Allocations for Poverty
Populations and Cost of Service'', dated March
30, 1990, and prepared by Health Economics
Research, a corporation, pursuant to a contract
with the National Institute on Drug Abuse.
(C) The factor determined under this
paragraph for the State involved may not for
any fiscal year be greater than 1.1 or less
than 0.9.
(D)(i) Not later than October 1, 1992, the
Secretary, after consultation with the
Comptroller General, shall in accordance with
this section make a determination for each
State of the factor that is to be in effect for
the State under this paragraph. The factor so
determined shall remain in effect through
fiscal year 1994, and shall be recalculated
every third fiscal year thereafter.
(ii) After consultation with the
Comptroller General, the Secretary shall,
through publication in the Federal Register,
periodically make such refinements in the
methodology referred to in subparagraph (B) as
are consistent with the purpose described in
subparagraph (A).
(b) Minimum Allotments for States.--With respect to fiscal
year 2000, and subsequent fiscal years, the amount of the
allotment of a State under section 1911 shall not be less than
the amount the State received under such section for fiscal
year 1998.
(c) Territories.--
(1) Determination under formula.--Subject to
paragraphs (2) and (4), the amount of an allotment
under section 1911 for a territory of the United States
for a fiscal year shall be the product of--
(A) an amount equal to the amounts reserved
under paragraph (3) for the fiscal year; and
(B) a percentage equal to the quotient of--
(i) the civilian population of the
territory, as indicated by the most
recently available data; divided by
(ii) the aggregate civilian
population of the territories of the
United States, as indicated by such
data.
(2) Minimum allotment for territories.--The amount
of an allotment under section 1911 for a territory of
the United States for a fiscal year shall be the
greater of--
(A) the amount determined under paragraph
(1) for the territory for the fiscal year;
(B) $50,000; and
(C) with respect to fiscal years 1993 and
1994, an amount equal to 20.6 percent of the
amount received by the territory from
allotments made pursuant to this part for
fiscal year 1992.
(3) Reservation of amounts.--The Secretary shall
each fiscal year reserve for the territories of the
United States 1.5 percent of the amounts appropriated
under section 1920(a) for allotments under section 1911
for the fiscal year.
(4) Availability of data on population.--With
respect to data on the civilian population of the
territories of the United States, if the Secretary
determines for a fiscal year that recent such data for
purposes of paragraph (1)(B) do not exist regarding a
territory, the Secretary shall for such purposes
estimate the civilian population of the territory by
modifying the data on the territory to reflect the
average extent of change occurring during the ensuing
period in the population of all territories with
respect to which recent such data do exist.
(5) Applicability of certain provisions.--For
purposes of subsection (a), the term ``State'' does not
include the territories of the United States.
SEC. 1919. [300X-8] DEFINITIONS.
For purposes of this subpart:
(1) The terms ``adults with a serious mental
illness'' and ``children with a serious emotional
disturbance'' have the meanings given such terms under
section 1912(c)(1).
(2) The term ``funding agreement'', with respect to
a grant under section 1911 to a State, means that the
Secretary may make such a grant only if the State makes
the agreement involved.
H4 deg.SEC. 1920. [300X-9] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this subpart, and subpart III and section 505 with
respect to mental health, there are authorized to be
appropriated $450,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal years 2002 and 2003.
(b) Allocations for Technical Assistance, Data Collection,
and Program Evaluation.--
(1) In general.--For the purpose of carrying out
section 1948(a) with respect to mental health and the
purposes specified in paragraphs (2) and (3), the
Secretary shall obligate 5 percent of the amounts
appropriated under subsection (a) for a fiscal year.
(2) Data collection.--The purpose specified in this
paragraph is carrying out sections 505 and 1971 with
respect to mental health.
(3) Program evaluation.--The purpose specified in
this paragraph is the conduct of evaluations of
prevention and treatment programs and services with
respect to mental health to determine methods for
improving the availability and quality of such programs
and services.
Subpart II--Block Grants for Prevention and Treatment of Substance
Abuse
H4 deg.SEC. 1921. [300X-21] FORMULA GRANTS TO STATES.
(a) In General.--For the purpose described in subsection
(b), the Secretary, acting through the Center for Substance
Abuse Treatment, shall make an allotment each fiscal year for
each State in an amount determined in accordance with section
1933. The Secretary shall make a grant to the State of the
allotment made for the State for the fiscal year if the State
submits to the Secretary an application in accordance with
section 1932.
(b) Authorized Activities.--A funding agreement for a grant
under subsection (a) is that, subject to section 1931, the
State involved will expend the grant only for the purpose of
planning, carrying out, and evaluating activities to prevent
and treat substance abuse and for related activities authorized
in section 1924.
H4 deg.SEC. 1922. [300X-22] CERTAIN ALLOCATIONS.
(a) Allocation Regarding Primary Prevention Programs.--A
funding agreement for a grant under section 1921 is that, in
expending the grant, the State involved--
(1) will expend not less than 20 percent for
programs for individuals who do not require treatment
for substance abuse, which programs--
(A) educate and counsel the individuals on
such abuse; and
(B) provide for activities to reduce the
risk of such abuse by the individuals;
(2) will, in carrying out paragraph (1)--
(A) give priority to programs for
populations that are at risk of developing a
pattern of such abuse; and
(B) ensure that programs receiving priority
under subparagraph (A) develop community-based
strategies for the prevention of such abuse,
including strategies to discourage the use of
alcoholic beverages and tobacco products by
individuals to whom it is unlawful to sell or
distribute such beverages or products.
(b) \1\ Allocations Regarding Women.--
---------------------------------------------------------------------------
\1\ Paragraph (2)(A) of section 3303(f) of Public Law 106-310 (114
Stat. 1211) provides as follows:
(2) Conforming amendments.--Effective upon the publication of
the regulations developed in accordance with section 1932(e)(1)
of the Public Health Service Act (42 U.S.C. 300x-32(d))--
(A) section 1922(c) of the Public Health Service Act
(42 U.S.C. 300x-22(c)) is amended by--
(i) striking paragraph (2); and
(ii) redesignating paragraph (3) as paragraph
(2); and
The reference to section 1922(c) probably should be a reference to
section 1922(b), as amended by section 3303(a) of such Public Law.
---------------------------------------------------------------------------
(1) In general.--Subject to paragraph (2), a
funding agreement for a grant under section 1921 for a
fiscal year is that--
(A) in the case of a grant for fiscal year
1993, the State involved will expend not less
than 5 percent of the grant to increase
(relative to fiscal year 1992) the availability
of treatment services designed for pregnant
women and women with dependent children (either
by establishing new programs or expanding the
capacity of existing programs);
(B) in the case of a grant for fiscal year
1994, the State will expend not less than 5
percent of the grant to so increase (relative
to fiscal year 1993) the availability of such
services for such women; and
(C) in the case of a grant for any
subsequent fiscal year, the State will expend
for such services for such women not less than
an amount equal to the amount expended by the
State for fiscal year 1994.
(2) Waiver.--
(A) Upon the request of a State, the
Secretary may provide to the State a waiver of
all or part of the requirement established in
paragraph (1) if the Secretary determines that
the State is providing an adequate level of
treatments services for women described in such
paragraph, as indicated by a comparison of the
number of such women seeking the services with
the availability in the State of the services.
(B) The Secretary shall approve or deny a
request for a waiver under subparagraph (A) not
later than 120 days after the date on which the
request is made.
(C) Any waiver provided by the Secretary
under subparagraph (A) shall be applicable only
to the fiscal year involved.
(3) Childcare and prenatal care.--A funding
agreement for a grant under section 1921 for a State is
that each entity providing treatment services with
amounts reserved under paragraph (1) by the State will,
directly or through arrangements with other public or
nonprofit private entities, make available prenatal
care to women receiving such services and, while the
women are receiving the services, childcare.
H4 deg.SEC. 1923. [300X-23] INTRAVENOUS SUBSTANCE ABUSE.
(a) Capacity of Treatment Programs.--
(1) Notification of reaching capacity.--A funding
agreement for a grant under section 1921 is that the
State involved will, in the case of programs of
treatment for intravenous drug abuse, require that any
such program receiving amounts from the grant, upon
reaching 90 percent of its capacity to admit
individuals to the program, provide to the State a
notification of such fact.
(2) Provision of treatment.--A funding agreement
for a grant under section 1921 is that the State
involved will, with respect to notifications under
paragraph (1), ensure that each individual who requests
and is in need of treatment for intravenous drug abuse
is admitted to a program of such treatment not later
than--
(A) 14 days after making the request for
admission to such a program; or
(B) 120 days after the date of such
request, if no such program has the capacity to
admit the individual on the date of such
request and if interim services are made
available to the individual not later than 48
hours after such request.
(b) Outreach Regarding Intravenous Substance Abuse.--A
funding agreement for a grant under section 1921 is that the
State involved, in providing amounts from the grant to any
entity for treatment services for intravenous drug abuse, will
require the entity to carry out activities to encourage
individuals in need of such treatment to undergo treatment.
SEC. 1924. [300X-24] REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN
IMMUNODEFICIENCY VIRUS.
(a) Tuberculosis.--
(1) In general.--A funding agreement for a grant
under section 1921 is that the State involved will
require that any entity receiving amounts from the
grant for operating a program of treatment for
substance abuse--
(A) will, directly or through arrangements
with other public or nonprofit private
entities, routinely make available tuberculosis
services to each individual receiving treatment
for such abuse; and
(B) in the case of an individual in need of
such treatment who is denied admission to the
program on the basis of the lack of the
capacity of the program to admit the
individual, will refer the individual to
another provider of tuberculosis services.
(2) Tuberculosis services.--For purposes of
paragraph (1), the term ``tuberculosis services'', with
respect to an individual, means--
(A) counseling the individual with respect
to tuberculosis;
(B) testing to determine whether the
individual has contracted such disease and
testing to determine the form of treatment for
the disease that is appropriate for the
individual; and
(C) providing such treatment to the
individual.
(b) Human Immunodeficiency Virus.--
(1) Requirement for certain states.--In the case of
a State described in paragraph (2), a funding agreement
for a grant under section 1921 is that--
(A) with respect to individuals undergoing
treatment for substance abuse, the State will,
subject to paragraph (3), carry out 1 or more
projects to make available to the individuals
early intervention services for HIV disease at
the sites at which the individuals are
undergoing such treatment;
(B) for the purpose of providing such early
intervention services through such projects,
the State will make available from the grant
the percentage that is applicable for the State
under paragraph (4); and
(C) the State will, subject to paragraph
(5), carry out such projects only in geographic
areas of the State that have the greatest need
for the projects.
(2) Designated states.--For purposes of this
subsection, a State described in this paragraph is any
State whose rate of cases of acquired immune deficiency
syndrome is 10 or more such cases per 100,000
individuals (as indicated by the number of such cases
reported to and confirmed by the Director of the
Centers for Disease Control for the most recent
calendar year for which such data are available).
(3) Use of existing programs regarding substance
abuse.--With respect to programs that provide treatment
services for substance abuse, a funding agreement for a
grant under section 1921 for a designated State is that
each such program participating in a project under
paragraph (1) will be a program that began operation
prior to the fiscal year for which the State is
applying to receive the grant. A program that so began
operation may participate in a project under paragraph
(1) without regard to whether the program has been
providing early intervention services for HIV disease.
(4) Applicable percentage regarding expenditures
for services.--
(A)(i) For purposes of paragraph (1)(B),
the percentage that is applicable under this
paragraph for a designated State is, subject to
subparagraph (B), the percentage by which the
amount of the grant under section 1921 for the
State for the fiscal year involved is an
increase over the amount specified in clause
(ii).
(ii) The amount specified in this clause is
the amount that was reserved by the designated
State involved from the allotment of the State
under section 1912A for fiscal year 1991 in
compliance with section 1916(c)(6)(A)(ii) (as
such sections were in effect for such fiscal
year).
(B) If the percentage determined under
subparagraph (A) for a designated State for a
fiscal year is less than 2 percent (including a
negative percentage, in the case of a State for
which there is no increase for purposes of such
subparagraph), the percentage applicable under
this paragraph for the State is 2 percent. If
the percentage so determined is 2 percent or
more, the percentage applicable under this
paragraph for the State is the percentage
determined under subparagraph (A), subject to
not exceeding 5 percent.
(5) Requirement regarding rural areas.--
(A) A funding agreement for a grant under
section 1921 for a designated State is that, if
the State will carry out 2 or more projects
under paragraph (1), the State will carry out 1
such project in a rural area of the State,
subject to subparagraph (B).
(B) The Secretary shall waive the
requirement established in subparagraph (A) if
the State involved certifies to the Secretary
that--
(i) there is insufficient demand in
the State to carry out a project under
paragraph (1) in any rural area of the
State; or
(ii) there are no rural areas in
the State.
(6) Manner of providing services.--With respect to
the provision of early intervention services for HIV
disease to an individual, a funding agreement for a
grant under section 1921 for a designated State is
that--
(A) such services will be undertaken
voluntarily by, and with the informed consent
of, the individual; and
(B) undergoing such services will not be
required as a condition of receiving treatment
services for substance abuse or any other
services.
(7) Definitions.--For purposes of this subsection:
(A) The term ``designated State'' means a
State described in paragraph (2).
(B) The term ``early intervention
services'', with respect to HIV disease,
means--
(i) appropriate pretest counseling;
(ii) testing individuals with
respect to such disease, including
tests to confirm the presence of the
disease, tests to diagnose the extent
of the deficiency in the immune system,
and tests to provide information on
appropriate therapeutic measures for
preventing and treating the
deterioration of the immune system and
for preventing and treating conditions
arising from the disease;
(iii) appropriate post-test
counseling; and
(iv) providing the therapeutic
measures described in clause (ii).
(C) The term ``HIV disease'' means
infection with the etiologic agent for acquired
immune deficiency syndrome.
(c) Expenditure of Grant for Compliance With Agreements.--
(1) In general.--A grant under section 1921 may be
expended for purposes of compliance with the agreements
required in this section, subject to paragraph (2).
(2) Limitation.--A funding agreement for a grant
under section 1921 for a State is that the grant will
not be expended to make payment for any service
provided for purposes of compliance with this section
to the extent that payment has been made, or can
reasonably be expected to be made, with respect to such
service--
(A) under any State compensation program,
under any insurance policy, or under any
Federal or State health benefits program
(including the program established in title
XVIII of the Social Security Act and the
program established in title XIX of such Act);
or
(B) by an entity that provides health
services on a prepaid basis.
(d) Maintenance of Effort.--With respect to services
provided for by a State for purposes of compliance with this
section, a funding agreement for a grant under section 1921 is
that the State will maintain expenditures of non-Federal
amounts for such services at a level that is not less than
average level of such expenditures maintained by the State for
2-year period preceding the first fiscal year for which the
State receives such a grant.
(e) Applicability of Certain Provision.--Section 1931
applies to this section (and to each other provision of this
subpart).
H4 deg.SEC. 1925. [300X-25] GROUP HOMES FOR RECOVERING
SUBSTANCE ABUSERS.
(a) State Revolving Funds for Establishment of Homes.--A
State, using funds available under section 1921, may establish
and maintain the ongoing operation of a revolving fund in
accordance with this section to support group homes for
recovering substance abusers as follows:
(1) The purpose of the fund is to make loans for
the costs of establishing programs for the provision of
housing in which individuals recovering from alcohol or
drug abuse may reside in groups of not less than 6
individuals. The fund is established directly by the
State or through the provision of a grant or contract
to a nonprofit private entity.
(2) The programs are carried out in accordance with
guidelines issued under subsection (b).
(3) Not less than $100,000 is available for the
fund.
(4) Loans made from the revolving fund do not
exceed $4,000 and each such loan is repaid to the
revolving fund by the residents of the housing involved
not later than 2 years after the date on which the loan
is made.
(5) Each such loan is repaid by such residents
through monthly installments, and a reasonable penalty
is assessed for each failure to pay such periodic
installments by the date specified in the loan
agreement involved.
(6) Such loans are made only to nonprofit private
entities agreeing that, in the operation of the program
established pursuant to the loan--
(A) the use of alcohol or any illegal drug
in the housing provided by the program will be
prohibited;
(B) any resident of the housing who
violates such prohibition will be expelled from
the housing;
(C) the costs of the housing, including
fees for rent and utilities, will be paid by
the residents of the housing; and
(D) the residents of the housing will,
through a majority vote of the residents,
otherwise establish policies governing
residence in the housing, including the manner
in which applications for residence in the
housing are approved.
(b) Issuance by Secretary of Guidelines.--The Secretary
shall ensure that there are in effect guidelines under this
subpart for the operation of programs described in subsection
(a).
(c) Applicability to Territories.--The requirements
established in subsection (a) shall not apply to any territory
of the United States other than the Commonwealth of Puerto
Rico.
H4 deg.SEC. 1926. [300X-26] STATE LAW REGARDING SALE OF
TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 18.
(a) Relevant Law.--
(1) In general.--Subject to paragraph (2), for
fiscal year 1994 and subsequent fiscal years, the
Secretary may make a grant under section 1921 only if
the State involved has in effect a law providing that
it is unlawful for any manufacturer, retailer, or
distributor of tobacco products to sell or distribute
any such product to any individual under the age of 18.
(2) Delayed applicability for certain states.--In
the case of a State whose legislature does not convene
a regular session in fiscal year 1993, and in the case
of a State whose legislature does not convene a regular
session in fiscal year 1994, the requirement described
in paragraph (1) as a condition of a receipt of a grant
under section 1921 shall apply only for fiscal year
1995 and subsequent fiscal years.
(b) Enforcement.--
(1) In general.--For the first applicable fiscal
year and for subsequent fiscal years, a funding
agreement for a grant under section 1921 is that the
State involved will enforce the law described in
subsection (a) in a manner that can reasonably be
expected to reduce the extent to which tobacco products
are available to individuals under the age of 18.
(2) Activities and reports regarding enforcement.--
For the first applicable fiscal year and for subsequent
fiscal years, a funding agreement for a grant under
section 1921 is that the State involved will--
(A) annually conduct random, unannounced
inspections to ensure compliance with the law
described in subsection (a); and
(B) annually submit to the Secretary a
report describing--
(i) the activities carried out by
the State to enforce such law during
the fiscal year preceding the fiscal
year for which the State is seeking the
grant;
(ii) the extent of success the
State has achieved in reducing the
availability of tobacco products to
individuals under the age of 18; and
(iii) the strategies to be utilized
by the State for enforcing such law
during the fiscal year for which the
grant is sought.
(c) Noncompliance of State.--Before making a grant under
section 1921 to a State for the first applicable fiscal year or
any subsequent fiscal year, the Secretary shall make a
determination of whether the State has maintained compliance
with subsections (a) and (b). If, after notice to the State and
an opportunity for a hearing, the Secretary determines that the
State is not in compliance with such subsections, the Secretary
shall reduce the amount of the allotment under such section for
the State for the fiscal year involved by an amount equal to--
(1) in the case of the first applicable fiscal
year, 10 percent of the amount determined under section
1933 for the State for the fiscal year;
(2) in the case of the first fiscal year following
such applicable fiscal year, 20 percent of the amount
determined under section 1933 for the State for the
fiscal year;
(3) in the case of the second such fiscal year, 30
percent of the amount determined under section 1933 for
the State for the fiscal year; and
(4) in the case of the third such fiscal year or
any subsequent fiscal year, 40 percent of the amount
determined under section 1933 for the State for the
fiscal year.
(d) Definition.--For purposes of this section, the term
``first applicable fiscal year'' means--
(1) fiscal year 1995, in the case of any State
described in subsection (a)(2); and
(2) fiscal year 1994, in the case of any other
State.
H4 deg.SEC. 1927. [300X-27] TREATMENT SERVICES FOR PREGNANT
WOMEN.
(a) In General.--A funding agreement for a grant under
section 1921 is that the State involved--
(1) will ensure that each pregnant woman in the
State who seeks or is referred for and would benefit
from such services is given preference in admissions to
treatment facilities receiving funds pursuant to the
grant; and
(2) will, in carrying out paragraph (1), publicize
the availability to such women of services from the
facilities and the fact that the women receive such
preference.
(b) Referrals Regarding States.--A funding agreement for a
grant under section 1921 is that, in carrying out subsection
(a)(1)--
(1) the State involved will require that, in the
event that a treatment facility has insufficient
capacity to provide treatment services to any woman
described in such subsection who seeks the services
from the facility, the facility refer the woman to the
State; and
(2) the State, in the case of each woman for whom a
referral under paragraph (1) is made to the State--
(A) will refer the woman to a treatment
facility that has the capacity to provide
treatment services to the woman; or
(B) will, if no treatment facility has the
capacity to admit the woman, make interim
services available to the woman not later than
48 hours after the women \1\ seeks the
treatment services.
---------------------------------------------------------------------------
\1\ So in law. See section 202 of Public Law 102-321 (106 Stat.
396). Probably should be ``woman''.
---------------------------------------------------------------------------
H4 deg.SEC. 1928. [300X-28] ADDITIONAL AGREEMENTS.
(a) Improvement of Process for Appropriate Referrals for
Treatment.--With respect to individuals seeking treatment
services, a funding agreement for a grant under section 1921 is
that the State involved will improve (relative to fiscal year
1992) the process in the State for referring the individuals to
treatment facilities that can provide to the individuals the
treatment modality that is most appropriate for the
individuals.
(b) Continuing Education.--With respect to any facility for
treatment services or prevention actitivities \2\ that is
receiving amounts from a grant under section 1921, a funding
agreement for a State for a grant under such section is that
continuing education in such services or activities (or both,
as the case may be) will be made available to employees of the
facility who provide the services or activities.
---------------------------------------------------------------------------
\2\ So in law. See section 202 of Public Law 102-321 (106 Stat.
396). Probably should be ``activities''.
---------------------------------------------------------------------------
(c) Coordination of Various Activities and Services.--A
funding agreement for a grant under section 1921 is that the
State involved will coordinate prevention and treatment
activities with the provision of other appropriate services
(including health, social, correctional and criminal justice,
educational, vocational rehabilitation, and employment
services).
(d) \1\ Waiver of Requirement.--
---------------------------------------------------------------------------
\1\Paragraph (2)(B) of section 3303(f) of Public Law 106-310 (114
Stat. 1211) provides as follows:
(2) Conforming amendments.--Effective upon the publication of
the regulations developed in accordance with section 1932(e)(1)
of the Public Health Service Act (42 U.S.C. 300x-32(d))--
(A) * * *
(B) section 1928(d) of the Public Health Service Act
(42 U.S.C. 300x-28(d)) is repealed.
(1) In general.--Upon the request of a State, the
Secretary may provide to a State a waiver of any or all
of the requirements established in this section if the
Secretary determines that, with respect to services for
the prevention and treatment of substance abuse, the
requirement involved is unnecessary for maintaining
quality in the provision of such services in the State.
(2) Date certain for acting upon request.--The
Secretary shall approve or deny a request for a waiver
under paragraph (1) not later than 120 days after the
date on which the request is made.
(3) Applicability of waiver.--Any waiver provided
by the Secretary under paragraph (1) shall be
applicable only to the fiscal year involved.
H4 deg.SEC. 1929. [300X-29] SUBMISSION TO SECRETARY OF
STATEWIDE ASSESSMENT OF NEEDS.
The Secretary may make a grant under section 1921 only if
the State submits to the Secretary an assessment of the need in
the State for authorized activities (which assessment is
conducted in accordance with criteria issued by the Secretary),
both by locality and by the State in general, which assessment
includes a description of--
(1) the incidence and prevalence in the State of
drug abuse and the incidence and prevalence in the
State of alcohol abuse and alcoholism;
(2) current prevention and treatment activities in
the State;
(3) the need of the State for technical assistance
to carry out such activities;
(4) efforts by the State to improve such
activities; and
(5) the extent to which the availability of such
activities is insufficient to meet the need for the
activities, the interim services to be made available
under sections 1923(a) and 1927(b), and the manner in
which such services are to be so available.
H4 deg.SEC. 1930. [300X-30] MAINTENANCE OF EFFORT REGARDING
STATE EXPENDITURES.
(a) In General.--With respect to the principal agency of a
State for carrying out authorized activities, a funding
agreement for a grant under section 1921 for the State for a
fiscal year is that such agency will for such year maintain
aggregate State expenditures for authorized activities at a
level that is not less than the average level of such
expenditures maintained by the State for the 2-year period
preceding the fiscal year for which the State is applying for
the grant.
(b) Exclusion of Certain Funds.--The Secretary may exclude
from the aggregate State expenditures under subsection (a),
funds appropriated to the principle agency for authorized
activities which are of a non-recurring nature and for a
specific purpose.
(c) Waiver.--
(1) In general.--Upon the request of a State, the
Secretary may waive all or part of the requirement
established in subsection (a) if the Secretary
determines that extraordinary economic conditions in
the State justify the waiver.
(2) Date certain for acting upon request.--The
Secretary shall approve or deny a request for a waiver
under paragraph (1) not later than 120 days after the
date on which the request is made.
(3) Applicability of waiver.--Any waiver provided
by the Secretary under paragraph (1) shall be
applicable only to the fiscal year involved.
(d) Noncompliance by State.--
(1) In general.--In making a grant under section
1921 to a State for a fiscal year, the Secretary shall
make a determination of whether, for the previous
fiscal year, the State maintained material compliance
with any agreement made under subsection (a). If the
Secretary determines that a State has failed to
maintain such compliance, the Secretary shall reduce
the amount of the allotment under section 1921 for the
State for the fiscal year for which the grant is being
made by an amount equal to the amount constituting such
failure for the previous fiscal year.
(2) Submission of information to secretary.--The
Secretary may make a grant under section 1921 for a
fiscal year only if the State involved submits to the
Secretary information sufficient for the Secretary to
make the determination required in paragraph (1).
H4 deg.SEC. 1931. [300X-31] RESTRICTIONS ON EXPENDITURE OF
GRANT.
(a) In General.--
(1) Certain restrictions.--A funding agreement for
a grant under section 1921 is that the State involved
will not expend the grant--
(A) to provide inpatient hospital services,
except as provided in subsection (b);
(B) to make cash payments to intended
recipients of health services;
(C) to purchase or improve land, purchase,
construct, or permanently improve (other than
minor remodeling) any building or other
facility, or purchase major medical equipment;
(D) to satisfy any requirement for the
expenditure of non-Federal funds as a condition
for the receipt of Federal funds;
(E) to provide financial assistance to any
entity other than a public or nonprofit private
entity; or
(F) to carry out any program prohibited by
section 256(b) of the Health Omnibus Programs
Extension of 1988 (42 U.S.C. 300ee-5).
(2) Limitation on administrative expenses.--A
funding agreement for a grant under section 1921 is
that the State involved will not expend more than 5
percent of the grant to pay the costs of administering
the grant.
(3) Limitation regarding penal and correctional
institutions.--A funding agreement for a State for a
grant under section 1921 is that, in expending the
grant for the purpose of providing treatment services
in penal or correctional institutions of the State, the
State will not expend more than an amount equal to the
amount expended for such purpose by the State from the
grant made under section 1912A to the State for fiscal
year 1991 (as section 1912A was in effect for such
fiscal year).
(b) Exception Regarding Inpatient Hospital Services.--
(1) Medical necessity as precondition.--With
respect to compliance with the agreement made under
subsection (a), a State may expend a grant under
section 1921 to provide inpatient hospital services as
treatment for substance abuse only if it has been
determined, in accordance with guidelines issued by the
Secretary, that such treatment is a medical necessity
for the individual involved, and that the individual
cannot be effectively treated in a community-based,
nonhospital, residential program of treatment.
(2) Rate of payment.--In the case of an individual
for whom a grant under section 1921 is expended to
provide inpatient hospital services described in
paragraph (1), a funding agreement for the grant for
the State involved is that the daily rate of payment
provided to the hospital for providing the services to
the individual will not exceed the comparable daily
rate provided for community-based, nonhospital,
residential programs of treatment for substance abuse.
(c) Waiver Regarding Construction of Facilities.--
(1) In general.--The Secretary may provide to any
State a waiver of the restriction established in
subsection (a)(1)(C) for the purpose of authorizing the
State to expend a grant under section 1921 for the
construction of a new facility or rehabilitation of an
existing facility, but not for land acquisition.
(2) Standard regarding need for waiver.--The
Secretary may approve a waiver under paragraph (1) only
if the State demonstrates to the Secretary that
adequate treatment cannot be provided through the use
of existing facilities and that alternative facilities
in existing suitable buildings are not available.
(3) Amount.--In granting a waiver under paragraph
(1), the Secretary shall allow the use of a specified
amount of funds to construct or rehabilitate a
specified number of beds for residential treatment and
a specified number of slots for outpatient treatment,
based on reasonable estimates by the State of the costs
of construction or rehabilitation. In considering
waiver applications, the Secretary shall ensure that
the State has carefully designed a program that will
minimize the costs of additional beds.
(4) Matching funds.--The Secretary may grant a
waiver under paragraph (1) only if the State agrees,
with respect to the costs to be incurred by the State
in carrying out the purpose of the waiver, to make
available non-Federal contributions in cash toward such
costs in an amount equal to not less than $1 for each
$1 of Federal funds provided under section 1921.
(5) Date certain for acting upon request.--The
Secretary shall act upon a request for a waiver under
paragraph (1) not later than 120 days after the date on
which the request is made.
H4 deg.SEC. 1932. [300X-32] APPLICATION FOR GRANT; APPROVAL
OF STATE PLAN.
(a) In General.--For purposes of section 1921, an
application for a grant under such section for a fiscal year is
in accordance with this section if, subject to subsections (c)
and (d)(2)--
(1) the application is received by the Secretary
not later than October 1 of the fiscal year for which
the State is seeking funds;
(2) the application contains each funding agreement
that is described in this subpart or subpart III for
such a grant (other than any such agreement that is not
applicable to the State);
(3) the agreements are made through certification
from the chief executive officer of the State;
(4) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary;
(5) the application contains the information
required in section 1929, the information required in
section 1930(c)(2), and the report required in section
1942(a);
(6)(A) the application contains a plan in
accordance with subsection (b) and the plan is approved
by the Secretary; and
(B) the State provides assurances satisfactory to
the Secretary that the State complied with the
provisions of the plan under subparagraph (A) that was
approved by the Secretary for the most recent fiscal
year for which the State received a grant under section
1921; and
(7) the application (including the plan under
paragraph (6)) is otherwise in such form, is made in
such manner, and contains such agreements, assurances,
and information as the Secretary determines to be
necessary to carry out this subpart.
(b) State Plan.--
(1) In general.--A plan submitted by a State under
subsection (a)(6) is in accordance with this subsection
if the plan contains detailed provisions for complying
with each funding agreement for a grant under section
1921 that is applicable to the State, including a
description of the manner in which the State intends to
expend the grant.
(2) Authority of secretary regarding
modifications.--As a condition of making a grant under
section 1921 to a State for a fiscal year, the
Secretary may require that the State modify any
provision of the plan submitted by the State under
subsection (a)(6) (including provisions on priorities
in carrying out authorized activities). If the
Secretary approves the plan and makes the grant to the
State for the fiscal year, the Secretary may not during
such year require the State to modify the plan.
(3) Authority of center for substance abuse
prevention.--With respect to plans submitted by the
States under subsection (a)(6), the Secretary, acting
through the Director of the Center for Substance Abuse
Prevention, shall review and approve or disapprove the
provisions of the plans that relate to prevention
activities.
(c) Waivers Regarding Certain Territories.--In the case of
any territory of the United States except Puerto Rico, the
Secretary may waive such provisions of this subpart and subpart
III as the Secretary determines to be appropriate, other than
the provisions of section 1931.
(d) Issuance of Regulations; Precondition to Making
Grants.--
(1) Regulations.--Not later than August 25, 1992,
the Secretary, acting as appropriate through the
Director of the Center for Treatment Improvement or the
Director of the Center for Substance Abuse Prevention,
shall by regulation establish standards specifying the
circumstances in which the Secretary will consider an
application for a grant under section 1921 to be in
accordance with this section.
(2) Issuance as precondition to making grants.--The
Secretary may not make payments under any grant under
section 1921 for fiscal year 1993 on or after January
1, 1993, unless the Secretary has issued standards
under paragraph (1).
(e) Waiver Authority for Certain Requirements.--
(1) In general.--Upon the request of a State, the
Secretary may waive the requirements of all or part of
the sections described in paragraph (2) using objective
criteria established by the Secretary by regulation
after consultation with the States and other interested
parties including consumers and providers.
(2) Sections.--The sections described in paragraph
(1) are sections 1922(c), 1923, 1924 and 1928.
(3) Date certain for acting upon request.--The
Secretary shall approve or deny a request for a waiver
under paragraph (1) and inform the State of that
decision not later than 120 days after the date on
which the request and all the information needed to
support the request are submitted.
(4) Annual reporting requirement.--The Secretary
shall annually report to the general public on the
States that receive a waiver under this subsection.
H4 deg.SEC. 1933. [300X-33] DETERMINATION OF AMOUNT OF
ALLOTMENT.
(a) States.--
(1) In general.--Subject to subsection (b), the
Secretary shall determine the amount of the allotment
required in section 1921 for a State for a fiscal year
as follows:
(A) The formula established in paragraph
(1) of section 1918(a) shall apply to this
subsection to the same extent and in the same
manner as the formula applies for purposes of
section 1918(a), except that, in the
application of such formula for purposes of
this subsection, the modifications described in
subparagraph (B) shall apply.
(B) For purposes of subparagraph (A), the
modifications described in this subparagraph
are as follows:
(i) The amount specified in
paragraph (2)(A) of section 1918(a) is
deemed to be the amount appropriated
under section 1935(a) for allotments
under section 1921 for the fiscal year
involved.
(ii) The term ``P'' is deemed to
have the meaning given in paragraph (2)
of this subsection. Section
1918(a)(5)(B) applies to the data used
in determining such term for the
States.
(iii) The factor determined under
paragraph (8) of section 1918(a) is
deemed to have the purpose of
reflecting the differences that exist
between the State involved and other
States in the costs of providing
authorized services.
(2) Determination of term ``p''.--For purposes of
this subsection, the term ``P'' means the percentage
that is the arithmetic mean of the percentage
determined under subparagraph (A) and the percentage
determined under subparagraph (B), as follows:
(A) The percentage constituted by the ratio
of--
(i) an amount equal to the sum of
the total number of individuals who
reside in the State involved and are
between 18 and 24 years of age
(inclusive) and the number of
individuals in the State who reside in
urbanized areas of the State and are
between such years of age; to
(ii) an amount equal to the total
of the respective sums determined for
the States under clause (i).
(B) The percentage constituted by the ratio
of--
(i) the total number of individuals
in the State who are between 25 and 64
years of age (inclusive); to
(ii) an amount equal to the sum of
the respective amounts determined for
the States under clause (i).
(b) Minimum Allotments for States.--
(1) In general.--With respect to fiscal year 2000,
and each subsequent fiscal year, the amount of the
allotment of a State under section 1921 shall not be
less than the amount the State received under such
section for the previous fiscal year increased by an
amount equal to 30.65 percent of the percentage by
which the aggregate amount allotted to all States for
such fiscal year exceeds the aggregate amount allotted
to all States for the previous fiscal year.
(2) Limitations.--
(A) In general.--Except as provided in
subparagraph (B), a State shall not receive an
allotment under section 1921 for a fiscal year
in an amount that is less than an amount equal
to 0.375 percent of the amount appropriated
under section 1935(a) for such fiscal year.
(B) Exception.--In applying subparagraph
(A), the Secretary shall ensure that no State
receives an increase in its allotment under
section 1921 for a fiscal year (as compared to
the amount allotted to the State in the prior
fiscal year) that is in excess of an amount
equal to 300 percent of the percentage by which
the amount appropriated under section 1935(a)
for such fiscal year exceeds the amount
appropriated for the prior fiscal year.
(3) Decrease in or equal appropriations.--If the
amount appropriated under section 1935(a) for a fiscal
year is equal to or less than the amount appropriated
under such section for the prior fiscal year, the
amount of the State allotment under section 1921 shall
be equal to the amount that the State received under
section 1921 in the prior fiscal year decreased by the
percentage by which the amount appropriated for such
fiscal year is less than the amount appropriated or
such section for the prior fiscal year.
(c) Territories.--
(1) Determination under formula.--Subject to
paragraphs (2) and (4), the amount of an allotment
under section 1921 for a territory of the United States
for a fiscal year shall be the product of--
(A) an amount equal to the amounts reserved
under paragraph (3) for the fiscal year; and
(B) a percentage equal to the quotient of--
(i) the civilian population of the
territory, as indicated by the most
recently available data; divided by
(ii) the aggregate civilian
population of the territories of the
United States, as indicated by such
data.
(2) Minimum allotment for territories.--The amount
of an allotment under section 1921 for a territory of
the United States for a fiscal year shall be the
greater of--
(A) the amount determined under paragraph
(1) for the territory for the fiscal year;
(B) $50,000; and
(C) with respect to fiscal years 1993 and
1994, an amount equal to 79.4 percent of the
amount received by the territory from
allotments made pursuant to this part for
fiscal year 1992.
(3) Reservation of amounts.--The Secretary shall
each fiscal year reserve for the territories of the
United States 1.5 percent of the amounts appropriated
under section 1935(a) for allotments under section 1921
for the fiscal year.
(4) Availability of data on population.--With
respect to data on the civilian population of the
territories of the United States, if the Secretary
determines for a fiscal year that recent such data for
purposes of paragraph (1)(B) do not exist regarding a
territory, the Secretary shall for such purposes
estimate the civilian population of the territory by
modifying the data on the territory to reflect the
average extent of change occurring during the ensuing
period in the population of all territories with
respect to which recent such data do exist.
(5) Applicability of certain provisions.--For
purposes of subsections (a) and (b), the term ``State''
does not include the territories of the United States.
(d) Indian tribes and tribal organizations.--
(1) In general.--If the Secretary--
(A) receives a request from the governing
body of an Indian tribe or tribal organization
within any State that funds under this subpart
be provided directly by the Secretary to such
tribe or organization; and
(B) makes a determination that the members
of such tribe or tribal organization would be
better served by means of grants made directly
by the Secretary under this; \1\
---------------------------------------------------------------------------
\1\ So in law. See section 102 of Public Law 102-321 (106 Stat.
402). Probably should be ``under this subpart''.
---------------------------------------------------------------------------
the Secretary shall reserve from the allotment under
section 1921 for the State for the fiscal year involved
an amount that bears the same ratio to the allotment as
the amount provided under this subpart to the tribe or
tribal organization for fiscal year 1991 for activities
relating to the prevention and treatment of the abuse
of alcohol and other drugs bore to the amount of the
portion of the allotment under this subpart for the
State for such fiscal year that was expended for such
activities.
(2) Tribe or tribal organization as grantee.--The
amount reserved by the Secretary on the basis of a
determination under this paragraph \2\ shall be granted
to the Indian tribe or tribal organization serving the
individuals for whom such a determination has been
made.
---------------------------------------------------------------------------
\2\ So in law. See section 102 of Public Law 102-321 (106 Stat.
402). Probably should be ``subsection''.
---------------------------------------------------------------------------
(3) Application.--In order for an Indian tribe or
tribal organization to be eligible for a grant for a
fiscal year under this paragraph, it shall submit to
the Secretary a plan for such fiscal year that meets
such criteria as the Secretary may prescribe.
(4) Definition.--The terms ``Indian tribe'' and
``tribal organization'' have the same meaning given
such terms in subsections (b) and (c) of section 4 of
the Indian Self-Determination and Education Assistance
Act.
H4 deg.SEC. 1934. [300X-34] DEFINITIONS.
For purposes of this subpart:
(1) The term ``authorized activities'', subject to
section 1931, means the activities described in section
1921(b).
(2) The term ``funding agreement'', with respect to
a grant under section 1921 to a State, means that the
Secretary may make such a grant only if the State makes
the agreement involved.
(3) The term ``prevention activities'', subject to
section 1931, means activities to prevent substance
abuse.
(4) The term ``substance abuse'' means the abuse of
alcohol or other drugs.
(5) The term ``treatment activities'' means
treatment services and, subject to section 1931,
authorized activities that are related to treatment
services.
(6) The term ``treatment facility'' means an entity
that provides treatment services.
(7) The term ``treatment services'', subject to
section 1931, means treatment for substance abuse.
H4 deg.SEC. 1935. [300X-35] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
carrying out this subpart, subpart III and section 505 with
respect to substance abuse, and section 515(d), there are
authorized to be appropriated $2,000,000,000 for fiscal year
2001, and such sums as may be necessary for each of the fiscal
years 2002 and 2003.
(b) Allocations for Technical Assistance, National Data
Base, Data Collection, and Program Evaluations.--
(1) In general.--
(A) For the purpose of carrying out section
1948(a) with respect to substance abuse,
section 515(d), and the purposes specified in
subparagraphs (B) and (C), the Secretary shall
obligate 5 percent of the amounts appropriated
under subsection (a) each fiscal year.
(B) The purpose specified in this
subparagraph is the collection of data in this
paragraph \1\ is carrying out sections 505 and
1971 with respect to substance abuse.
---------------------------------------------------------------------------
\1\ So in law. See section 202 of Public Law 102-321 (106 Stat.
403). The words ``the collection of data in this paragraph'' probably
should not appear.
---------------------------------------------------------------------------
(C) The purpose specified in this
subparagraph is the conduct of evaluations of
authorized activities to determine methods for
improving the availability and quality of such
activities.
(2) Activities of center for substance abuse
prevention.--Of the amounts reserved under paragraph
(1) for a fiscal year, the Secretary, acting through
the Director of the Center for Substance Abuse
Prevention, shall obligate 20 percent for carrying out
paragraph (1)(C), section 1948(a) with respect to
prevention activities, and section 515(d).
(3) Core data set.--A State that receives a new
grant, contract, or cooperative agreement from amounts
available to the Secretary under paragraph (1), for the
purposes of improving the data collection, analysis and
reporting capabilities of the State, shall be required,
as a condition of receipt of funds, to collect,
analyze, and report to the Secretary for each fiscal
year subsequent to receiving such funds a core data set
to be determined by the Secretary in conjunction with
the States.
Subpart III--General Provisions
H4 deg.SEC. 1941. [300X-51] OPPORTUNITY FOR PUBLIC COMMENT
ON STATE PLANS.
A funding agreement for a grant under section 1911 or 1921
is that the State involved will make the plan required in
section 1912, and the plan required in section 1932,
respectively, public within the State in such manner as to
facilitate comment from any person (including any Federal or
other public agency) during the development of the plan
(including any revisions) and after the submission of the plan
to the Secretary.
H4 deg.SEC. 1942. [300X-52] REQUIREMENT OF REPORTS AND
AUDITS BY STATES.
(a) Report.--A funding agreement for a grant under section
1911 or 1921 is that the State involved will submit to the
Secretary a report in such form and containing such information
as the Secretary determines (after consultation with the
States) to be necessary for securing a record and a description
of--
(1) the purposes for which the grant received by
the State for the preceding fiscal year under the
program involved were expended and a description of the
activities of the State under the program; and
(2) the recipients of amounts provided in the
grant.
(b) Audits.--A funding agreement for a grant under section
1911 or 1921 is that the State will, with respect to the grant,
comply with chapter 75 of title 31, United States Code.
(c) Availability to Public.--A funding agreement for a
grant under section 1911 or 1921 is that the State involved
will--
(1) make copies of the reports and audits described
in this section available for public inspection within
the State; and
(2) provide copies of the report under subsection
(a), upon request, to any interested person (including
any public agency).
H4 deg.SEC. 1943. [300X-53] ADDITIONAL REQUIREMENTS.
(a) In General.--A funding agreement for a grant under
section 1911 or 1921 is that the State involved will--
(1)(A) for the fiscal year for which the grant
involved is provided, provide for independent peer
review to assess the quality, appropriateness, and
efficacy of treatment services provided in the State to
individuals under the program involved; and
(B) ensure that, in the conduct of such peer
review, not fewer than 5 percent of the entities
providing services in the State under such program are
reviewed (which 5 percent is representative of the
total population of such entities);
(2) permit and cooperate with Federal
investigations undertaken in accordance with section
1945; and
(3) provide to the Secretary any data required by
the Secretary pursuant to section 505 and will
cooperate with the Secretary in the development of
uniform criteria for the collection of data pursuant to
such section.
(b) Patient Records.--The Secretary may make a grant under
section 1911 or 1921 only if the State involved has in effect a
system to protect from inappropriate disclosure patient records
maintained by the State in connection with an activity funded
under the program involved or by any entity which is receiving
amounts from the grant.
H4 deg.SEC. 1944. [300X-54] DISPOSITION OF CERTAIN FUNDS
APPROPRIATED FOR ALLOTMENTS.
(a) In General.--Amounts described in subsection (b) and
available for a fiscal year pursuant to section 1911 or 1921,
as the case may be, shall be allotted by the Secretary and paid
to the States receiving a grant under the program involved,
other than any State referred to in subsection (b) with respect
to such program. Such amounts shall be allotted in a manner
equivalent to the manner in which the allotment under the
program involved was determined.
(b) Specification of Amounts.--The amounts referred to in
subsection (a) are any amounts that--
(1) are not paid to States under the program
involved as a result of--
(A) the failure of any State to submit an
application in accordance with the program;
(B) the failure of any State to prepare
such application in compliance with the
program; or
(C) any State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State under
the program;
(2) are terminated, repaid, or offset under section
1945;
(3) in the case of the program established in
section 1911, are available as a result of reductions
in allotments under such section pursuant to section
1912(d) or 1915(b); or
(4) in the case of the program established in
section 1921, are available as a result of reductions
in allotments under such section pursuant to section
1926 or 1930.
H4 deg.SEC. 1945. [300X-55] FAILURE TO COMPLY WITH
AGREEMENTS.
(a) Suspension or Termination of Payments.--Subject to
subsection (e), if the Secretary determines that a State has
materially failed to comply with the agreements or other
conditions required for the receipt of a grant under the
program involved, the Secretary may in whole or in part suspend
payments under the grant, terminate the grant for cause, or
employ such other remedies (including the remedies provided for
in subsections (b) and (c)) as may be legally available and
appropriate in the circumstances involved.
(b) Repayment of Payments.--
(1) In general.--Subject to subsection (e), the
Secretary may require a State to repay with interest
any payments received by the State under section 1911
or 1921 that the Secretary determines were not expended
by the State in accordance with the agreements required
under the program involved.
(2) Offset against payments.--If a State fails to
make a repayment required in paragraph (1), the
Secretary may offset the amount of the repayment
against the amount of any payment due to be paid to the
State under the program involved.
(c) Withholding of Payments.--
(1) In general.--Subject to subsections (e) and
(g)(3), the Secretary may withhold payments due under
section 1911 or 1921 if the Secretary determines that
the State involved is not expending amounts received
under the program involved in accordance with the
agreements required under the program.
(2) Termination of withholding.--The Secretary
shall cease withholding payments from a State under
paragraph (1) if the Secretary determines that there
are reasonable assurances that the State will expend
amounts received under the program involved in
accordance with the agreements required under the
program.
(d) Applicability of Remedies to Certain Violations.--
(1) In general.--With respect to agreements or
other conditions for receiving a grant under the
program involved, in the case of the failure of a State
to maintain material compliance with a condition
referred to in paragraph (2), the provisions for
noncompliance with the condition that are provided in
the section establishing the condition shall apply in
lieu of subsections (a) through (c) of this section.
(2) Relevant conditions.--For purposes of paragraph
(1):
(A) In the case of the program established
in section 1911, a condition referred to in
this paragraph is the condition established in
section 1912(d) and the condition established
in section 1915(b).
(B) In the case of the program established
in section 1921, a condition referred to in
this paragraph is the condition established in
section 1926 and the condition established in
section 1930.
(e) Opportunity for Hearing.--Before taking action against
a State under any of subsections (a) through (c) (or under a
section referred to in subsection (d)(2), as the case may be),
the Secretary shall provide to the State involved adequate
notice and an opportunity for a hearing.
(f) Requirement of Hearing in Certain Circumstances.--
(1) In general.--If the Secretary receives a
complaint that a State has failed to maintain material
compliance with the agreements or other conditions
required for receiving a grant under the program
involved (including any condition referred to for
purposes of subsection (d)), and there appears to be
reasonable evidence to support the complaint, the
Secretary shall promptly conduct a hearing with respect
to the complaint.
(2) Finding of material noncompliance.--If in a
hearing under paragraph (1) the Secretary finds that
the State involved has failed to maintain material
compliance with the agreement or other condition
involved, the Secretary shall take such action under
this section as may be appropriate to ensure that
material compliance is so maintained, or such action as
may be required in a section referred to in subsection
(d)(2), as the case may be.
(g) Certain Investigations.--
(1) Requirement regarding secretary.--The Secretary
shall in fiscal year 1994 and each subsequent fiscal
year conduct in not less than 10 States investigations
of the expenditure of grants received by the States
under section 1911 or 1921 in order to evaluate
compliance with the agreements required under the
program involved.
(2) Provision of records etc. upon request.--Each
State receiving a grant under section 1911 or 1921, and
each entity receiving funds from the grant, shall make
appropriate books, documents, papers, and records
available to the Secretary or the Comptroller General,
or any of their duly authorized representatives, for
examination, copying, or mechanical reproduction on or
off the premises of the appropriate entity upon a
reasonable request therefor.
(3) Limitations on authority.--The Secretary may
not institute proceedings under subsection (c) unless
the Secretary has conducted an investigation concerning
whether the State has expended payments under the
program involved in accordance with the agreements
required under the program. Any such investigation
shall be conducted within the State by qualified
investigators.
H4 deg.SEC. 1946. [300X-56] PROHIBITIONS REGARDING RECEIPT
OF FUNDS.
(a) Establishment.--
(1) Certain false statements and representations.--
A person shall not knowingly and willfully make or
cause to be made any false statement or representation
of a material fact in connection with the furnishing of
items or services for which payments may be made by a
State from a grant made to the State under section 1911
or 1921.
(2) Concealing or failing to disclose certain
events.--A person with knowledge of the occurrence of
any event affecting the initial or continued right of
the person to receive any payments from a grant made to
a State under section 1911 or 1921 shall not conceal or
fail to disclose any such event with an intent
fraudulently to secure such payment either in a greater
amount than is due or when no such amount is due.
(b) Criminal Penalty for Violation of Prohibition.--Any
person who violates any prohibition established in subsection
(a) shall for each violation be fined in accordance with title
18, United States Code, or imprisoned for not more than 5
years, or both.
H4 deg.SEC. 1947. [300X-57] NONDISCRIMINATION.
(a) In General.--
(1) Rule of construction regarding certain civil
rights laws.--For the purpose of applying the
prohibitions against discrimination on the basis of age
under the Age Discrimination Act of 1975, on the basis
of handicap under section 504 of the Rehabilitation Act
of 1973, on the basis of sex under title IX of the
Education Amendments of 1972, or on the basis of race,
color, or national origin under title VI of the Civil
Rights Act of 1964, programs and activities funded in
whole or in part with funds made available under
section 1911 or 1921 shall be considered to be programs
and activities receiving Federal financial assistance.
(2) Prohibition.--No person shall on the ground of
sex (including, in the case of a woman, on the ground
that the woman is pregnant), or on the ground of
religion, be excluded from participation in, be denied
the benefits of, or be subjected to discrimination
under, any program or activity funded in whole or in
part with funds made available under section 1911 or
1921.
(b) Enforcement.--
(1) Referrals to attorney general after notice.--
Whenever the Secretary finds that a State, or an entity
that has received a payment pursuant to section 1911 or
1921, has failed to comply with a provision of law
referred to in subsection (a)(1), with subsection
(a)(2), or with an applicable regulation (including one
prescribed to carry out subsection (a)(2)), the
Secretary shall notify the chief executive officer of
the State and shall request the chief executive officer
to secure compliance. If within a reasonable period of
time, not to exceed 60 days, the chief executive
officer fails or refuses to secure compliance, the
Secretary may--
(A) refer the matter to the Attorney
General with a recommendation that an
appropriate civil action be instituted;
(B) exercise the powers and functions
provided by the Age Discrimination Act of 1975,
section 504 of the Rehabilitation Act of 1973,
title IX of the Education Amendments of 1972,
or title VI of the Civil Rights Act of 1964, as
may be applicable; or
(C) take such other actions as may be
authorized by law.
(2) Authority of attorney general.--When a matter
is referred to the Attorney General pursuant to
paragraph (1)(A), or whenever the Attorney General has
reason to believe that a State or an entity is engaged
in a pattern or practice in violation of a provision of
law referred to in subsection (a)(1) or in violation of
subsection (a)(2), the Attorney General may bring a
civil action in any appropriate district court of the
United States for such relief as may be appropriate,
including injunctive relief.
H4 deg.SEC. 1948. [300X-58] TECHNICAL ASSISTANCE AND
PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT
FUNDS.
(a) Technical Assistance.--The Secretary shall, without
charge to a State receiving a grant under section 1911 or 1921,
provide to the State (or to any public or nonprofit private
entity within the State) technical assistance with respect to
the planning, development, and operation of any program or
service carried out pursuant to the program involved. The
Secretary may provide such technical assistance directly,
through contract, or through grants.
(b) Provision of Supplies and Services in Lieu of Grant
Funds.--
(1) In general.--Upon the request of a State
receiving a grant under section 1911 or 1921, the
Secretary may, subject to paragraph (2), provide
supplies, equipment, and services for the purpose of
aiding the State in carrying out the program involved
and, for such purpose, may detail to the State any
officer or employee of the Department of Health and
Human Services.
(2) Corresponding reduction in payments.--With
respect to a request described in paragraph (1), the
Secretary shall reduce the amount of payments under the
program involved to the State by an amount equal to the
costs of detailing personnel and the fair market value
of any supplies, equipment, or services provided by the
Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request,
expend the amounts withheld.
SEC. 1949. \1\ [300X-59] PLANS FOR PERFORMANCE PARTNERSHIPS.
---------------------------------------------------------------------------
\1\ Section 1949 appears according to the probable intent of the
Congress. Section 3403(a) of Public Law 106-310 (114 Stat. 1219)
provides that the section ``is amended as follows:''. No amendatory
instructions were then given, but a substitute text was provided. The
amendment probably should have instructed that section 1949 ``is
amended to read as follows:''.
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(a) Development.--The Secretary in conjunction with States
and other interested groups shall develop separate plans for
the programs authorized under subparts I and II for creating
more flexibility for States and accountability based on outcome
and other performance measures. The plans shall each include--
(1) a description of the flexibility that would be
given to the States under the plan;
(2) the common set of performance measures that
would be used for accountability, including measures
that would be used for the program under subpart II for
pregnant addicts, HIV transmission, tuberculosis, and
those with a co-occurring substance abuse and mental
disorders, and for programs under subpart I for
children with serious emotional disturbance and adults
with serious mental illness and for individuals with
co-occurring mental health and substance abuse
disorders;
(3) the definitions for the data elements to be
used under the plan;
(4) the obstacles to implementation of the plan and
the manner in which such obstacles would be resolved;
(5) the resources needed to implement the
performance partnerships under the plan; and
(6) an implementation strategy complete with
recommendations for any necessary legislation.
(b) Submission.--Not later than 2 years after the date of
the enactment of this Act \2\, the plans developed under
subsection (a) shall be submitted to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Commerce of the House of Representatives.
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\2\ The probable intent of the Congress was that the reference to
``this Act'' be a reference to the Children's Health Act of 2000
(Public Law 106-310), which provided a substitute text for section 1949
(see footnote 1), including subsection (b) above. That Act was enacted
October 17, 2000. (A reference to ``this Act'' is a reference to the
Public Health Service Act, which was enacted July 1, 1944.)
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(c) Information.--As the elements of the plans described in
subsection (a) are developed, States are encouraged to provide
information to the Secretary on a voluntary basis.
(d) Participants.--The Secretary shall include among those
interested groups that participate in the development of the
plan consumers of mental health or substance abuse services,
providers, representatives of political divisions of States,
and representatives of racial and ethnic groups including
Native Americans.
H4 deg.SEC. 1950. [300X-60] RULE OF CONSTRUCTION REGARDING
DELEGATION OF AUTHORITY TO STATES.
With respect to States receiving grants under section 1911
or 1921, this part may not be construed to authorize the
Secretary to delegate to the States the primary responsibility
for interpreting the governing provisions of this part.
SEC. 1951. [300X-61] SOLICITATION OF VIEWS OF CERTAIN ENTITIES.
In carrying out this part, the Secretary, as appropriate,
shall solicit the views of the States and other appropriate
entities.
SEC. 1952. \1\ [300X-62] AVAILABILITY TO STATES OF GRANT PAYMENTS.
---------------------------------------------------------------------------
\1\ Section 1952 appears according to the probable intent of the
Congress. Section 3403(b) of Public Law 106-310 (114 Stat. 1220)
provides that the section ``is amended as follows:''. No amendatory
instructions were then given, but a substitute text was provided. The
amendment probably should have instructed that section 1952 ``is
amended to read as follows:''.
---------------------------------------------------------------------------
Any amounts paid to a State for a fiscal year under section
1911 or 1921 shall be available for obligation and expenditure
until the end of the fiscal year following the fiscal year for
which the amounts were paid.
SEC. 1953. [300X-63] CONTINUATION OF CERTAIN PROGRAMS.
(a) In General.--Of the amount allotted to the State of
Hawaii under section 1911, and the amount allotted to such
State under section 1921, an amount equal to the proportion of
Native Hawaiians residing in the State to the total population
of the State shall be available, respectively, for carrying out
the program involved for Native Hawaiians.
(b) Expenditure of Amounts.--The amount made available
under subsection (a) may be expended only through contracts
entered into by the State of Hawaii with public and private
nonprofit organizations to enable such organizations to plan,
conduct, and administer comprehensive substance abuse and
treatment programs for the benefit of Native Hawaiians. In
entering into contracts under this section, the State of Hawaii
shall give preference to Native Hawaiian organizations and
Native Hawaiian health centers.
(c) Definitions.--For the purposes of this subsection \2\,
the terms ``Native Hawaiian'', ``Native Hawaiian
organization'', and ``Native Hawaiian health center'' have the
meaning given such terms in section 2308 of subtitle D of title
II of the Anti-Drug Abuse Act of 1988.
---------------------------------------------------------------------------
\2\ So in law. See section 203 of Public Law 102-321 (106 Stat.
409). Probably should be ``section''.
---------------------------------------------------------------------------
H4 deg.SEC. 1954. [300X-64] DEFINITIONS.
(a) Definitions for Subpart III.--For purposes of this
subpart:
(1) The term ``program involved'' means the program
of grants established in section 1911 or 1921, or both,
as indicated by whether the State involved is receiving
or is applying to receive a grant under section 1911 or
1921, or both.
(2)(A) The term ``funding agreement'', with respect
to a grant under section 1911, has the meaning given
such term in section 1919.
(B) The term ``funding agreement'', with respect to
a grant under section 1921, has the meaning given such
term in section 1934.
(b) Definitions for Part B.--For purposes of this part:
(1) The term ``Comptroller General'' means the
Comptroller General of the United States.
(2) The term ``State'', except as provided in
sections 1918(c)(5) and 1933(c)(5), means each of the
several States, the District of Columbia, and each of
the territories of the United States.
(3) The term ``territories of the United States''
means each of the Commonwealth of Puerto Rico, American
Samoa, Guam, the Commonwealth of the Northern Mariana
Islands, the Virgin Islands, Palau, the Marshall
Islands, and Micronesia.
(4) The term ``interim services'', in the case of
an individual in need of treatment for substance abuse
who has been denied admission to a program of such
treatment on the basis of the lack of the capacity of
the program to admit the individual, means services for
reducing the adverse health effects of such abuse, for
promoting the health of the individual, and for
reducing the risk of transmission of disease, which
services are provided until the individual is admitted
to such a program.
SEC. 1955. [300X-65] SERVICES PROVIDED BY NONGOVERNMENTAL
ORGANIZATIONS. \1\
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\1\ Part G of title V of this Act (the second part G; see page 677)
also relates to religious organizations as providers of substance abuse
services. That part was added by section 144 of the Community Renewal
Tax Relief Act of 2000 (as enacted into law by section 1(a)(7) of
Public Law 106-554; 114 Stat. 2763A-619). Section 1955 above was added
by section 3305 of Public Law 106-310 (114 Stat. 1212).
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(a) Purposes.--The purposes of this section are--
(1) to prohibit discrimination against
nongovernmental organizations and certain individuals
on the basis of religion in the distribution of
government funds to provide substance abuse services
under this title and title V, and the receipt of
services under such titles; and
(2) to allow the organizations to accept the funds
to provide the services to the individuals without
impairing the religious character of the organizations
or the religious freedom of the individuals.
(b) Religious Organizations Included as Nongovernmental
Providers.--
(1) In general.--A State may administer and provide
substance abuse services under any program under this
title or title V through grants, contracts, or
cooperative agreements to provide assistance to
beneficiaries under such titles with nongovernmental
organizations.
(2) Requirement.--A State that elects to utilize
nongovernmental organizations as provided for under
paragraph (1) shall consider, on the same basis as
other nongovernmental organizations, religious
organizations to provide services under substance abuse
programs under this title or title V, so long as the
programs under such titles are implemented in a manner
consistent with the Establishment Clause of the first
amendment to the Constitution. Neither the Federal
Government nor a State or local government receiving
funds under such programs shall discriminate against an
organization that provides services under, or applies
to provide services under, such programs, on the basis
that the organization has a religious character.
(c) Religious Character and Independence.--
(1) In general.--A religious organization that
provides services under any substance abuse program
under this title or title V shall retain its
independence from Federal, State, and local
governments, including such organization's control over
the definition, development, practice, and expression
of its religious beliefs.
(2) Additional safeguards.--Neither the Federal
Government nor a State or local government shall
require a religious organization--
(A) to alter its form of internal
governance; or
(B) to remove religious art, icons,
scripture, or other symbols,
in order to be eligible to provide services under any
substance abuse program under this title or title V.
(d) Employment Practices.--
(1) Substance abuse.--A religious organization that
provides services under any substance abuse program
under this title or title V may require that its
employees providing services under such program adhere
to rules forbidding the use of drugs or alcohol.
(2) Title vii exemption.--The exemption of a
religious organization provided under section 702 or
703(e)(2) of the Civil Rights Act of 1964 (42 U.S.C.
2000e-1, 2000e-2(e)(2)) regarding employment practices
shall not be affected by the religious organization's
provision of services under, or receipt of funds from,
any substance abuse program under this title or title
V.
(e) Rights of Beneficiaries of Assistance.--
(1) In general.--If an individual described in
paragraph (3) has an objection to the religious
character of the organization from which the individual
receives, or would receive, services funded under any
substance abuse program under this title or title V,
the appropriate Federal, State, or local governmental
entity shall provide to such individual (if otherwise
eligible for such services) within a reasonable period
of time after the date of such objection, services
that--
(A) are from an alternative provider that
is accessible to the individual; and
(B) have a value that is not less than the
value of the services that the individual would
have received from such organization.
(2) Notice.--The appropriate Federal, State, or
local governmental entity shall ensure that notice is
provided to individuals described in paragraph (3) of
the rights of such individuals under this section.
(3) Individual described.--An individual described
in this paragraph is an individual who receives or
applies for services under any substance abuse program
under this title or title V.
(f ) Nondiscrimination Against Beneficiaries.--A religious
organization providing services through a grant, contract, or
cooperative agreement under any substance abuse program under
this title or title V shall not discriminate, in carrying out
such program, against an individual described in subsection
(e)(3) on the basis of religion, a religious belief, a refusal
to hold a religious belief, or a refusal to actively
participate in a religious practice.
(g) Fiscal Accountability.--
(1) In general.--Except as provided in paragraph
(2), any religious organization providing services
under any substance abuse program under this title or
title V shall be subject to the same regulations as
other nongovernmental organizations to account in
accord with generally accepted accounting principles
for the use of such funds provided under such program.
(2) Limited audit.--Such organization shall
segregate government funds provided under such
substance abuse program into a separate account. Only
the government funds shall be subject to audit by the
government.
(h) Compliance.--Any party that seeks to enforce such
party's rights under this section may assert a civil action for
injunctive relief exclusively in an appropriate Federal or
State court against the entity, agency or official that
allegedly commits such violation.
(i) Limitations on Use of Funds for Certain Purposes.--No
funds provided through a grant or contract to a religious
organization to provide services under any substance abuse
program under this title or title V shall be expended for
sectarian worship, instruction, or proselytization.
( j) Effect on State and Local Funds.--If a State or local
government contributes State or local funds to carry out any
substance abuse program under this title or title V, the State
or local government may segregate the State or local funds from
the Federal funds provided to carry out the program or may
commingle the State or local funds with the Federal funds. If
the State or local government commingles the State or local
funds, the provisions of this section shall apply to the
commingled funds in the same manner, and to the same extent, as
the provisions apply to the Federal funds.
(k) Treatment of Intermediate Contractors.--If a
nongovernmental organization (referred to in this subsection as
an ``intermediate organization''), acting under a contract or
other agreement with the Federal Government or a State or local
government, is given the authority under the contract or
agreement to select nongovernmental organizations to provide
services under any substance abuse program under this title or
title V, the intermediate organization shall have the same
duties under this section as the government but shall retain
all other rights of a nongovernmental organization under this
section.
SEC. 1956. [300X-66] SERVICES FOR INDIVIDUALS WITH CO-OCCURRING
DISORDERS.
States may use funds available for treatment under sections
1911 and 1921 to treat persons with co-occurring substance
abuse and mental disorders as long as funds available under
such sections are used for the purposes for which they were
authorized by law and can be tracked for accounting purposes.
PART C--CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE
Subpart I--Data Infrastructure Development
SEC. 1971. [300Y] DATA INFRASTRUCTURE DEVELOPMENT.
(a) In General.--The Secretary may make grants to, and
enter into contracts or cooperative agreements with States for
the purpose of developing and operating mental health or
substance abuse data collection, analysis, and reporting
systems with regard to performance measures including capacity,
process, and outcomes measures.
(b) Projects.--The Secretary shall establish criteria to
ensure that services will be available under this section to
States that have a fundamental basis for the collection,
analysis, and reporting of mental health and substance abuse
performance measures and States that do not have such basis.
The Secretary will establish criteria for determining whether a
State has a fundamental basis for the collection, analysis, and
reporting of data.
(c) Condition of Receipt of Funds.--As a condition of the
receipt of an award under this section a State shall agree to
collect, analyze, and report to the Secretary within 2 years of
the date of the award on a core set of performance measures to
be determined by the Secretary in conjunction with the States.
(d) Matching Requirement.--
(1) In general.--With respect to the costs of the
program to be carried out under subsection (a) by a
State, the Secretary may make an award under such
subsection only if the applicant agrees to make
available (directly or through donations from public or
private entities) non-Federal contributions toward such
costs in an amount that is not less than 50 percent of
such costs.
(2) Determination of amount contributed.--Non-
Federal contributions under paragraph (1) may be in
cash or in kind, fairly evaluated, including plant,
equipment, or services. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such
contributions.
(e) Duration of Support.--The period during which payments
may be made for a project under subsection (a) may be not less
than 3 years nor more than 5 years.
(f ) Authorization of Appropriation.--
(1) In general.--For the purpose of carrying out
this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal
years 2001, 2002 and 2003.
(2) Allocation.--Of the amounts appropriated under
paragraph (1) for a fiscal year, 50 percent shall be
expended to support data infrastructure development for
mental health and 50 percent shall be expended to
support data infrastructure development for substance
abuse.
Subpart II--Interim Maintenance Treatment of Narcotics Dependence
SEC. 1976. [300Y-11] INTERIM MAINTENANCE TREATMENT.
(a) Requirement Regarding Secretary.--Subject to the
following subsections of this section, for the purpose of
reducing the incidence of the transmission of HIV disease
pursuant to the intravenous abuse of heroin or other morphine-
like drugs, the Secretary, in establishing conditions for the
use of methadone in public or nonprofit private programs of
treatment for dependence on such drugs, shall authorize such
programs--
(1) to dispense methadone for treatment purposes to
individuals who--
(A) meet the conditions for admission to
such programs that dispense methadone as part
of comprehensive treatment for such dependence;
and
(B) are seeking admission to such programs
that so dispense methadone, but as a result of
the limited capacity of the programs, will not
gain such admission until 14 or more days after
seeking admission to the programs; and
(2) in dispensing methadone to such individuals, to
provide only minimum ancillary services during the
period in which the individuals are waiting for
admission to programs of comprehensive treatment.
(b) Inapplicability of Requirement in Certain
Circumstances.--
(1) In general.--The requirement established in
subsection (a) for the Secretary does not apply if any
or all of the following conditions are met:
(A) The preponderance of scientific
research indicates that the risk of the
transmission of HIV disease pursuant to the
intravenous abuse of drugs is minimal.
(B) The preponderance of scientific
research indicates that the medically
supervised dispensing of methadone is not an
effective method of reducing the extent of
dependence on heroin and other morphine-like
drugs.
(C) The preponderance of available data
indicates that, of treatment programs that
dispense methadone as part of comprehensive
treatment, a substantial majority admit all
individuals seeking services to the programs
not later than 14 days after the individuals
seek admission to the programs.
(2) Evaluation by secretary.--In evaluating whether
any or all of the conditions described in paragraph (1)
have been met, the Secretary shall consult with the
National Commission on Acquired Immune Deficiency
Syndrome.
(c) Conditions for Obtaining Authorization From
Secretary.--
(1) In general.--In carrying out the requirement
established in subsection (a), the Secretary shall,
after consultation with the National Commission on
Acquired Immune Deficiency Syndrome, by regulation
issue such conditions for treatment programs to obtain
authorization from the Secretary to provide interim
maintenance treatment as may be necessary to carry out
the purpose described in such subsection. Such
conditions shall include conditions for preventing the
unauthorized use of methadone.
(2) Counseling on hiv disease.--The regulations
issued under paragraph (1) shall provide that an
authorization described in such paragraph may not be
issued to a treatment program unless the program
provides to recipients of the treatment counseling on
preventing exposure to and the transmission of HIV
disease.
(3) Permission of relevant state as condition of
authorization.--The regulations issued under paragraph
(1) shall provide that the Secretary may not provide an
authorization described in such paragraph to any
treatment program in a State unless the chief public
health officer of the State has certified to the
Secretary that--
(A) such officer does not object to the
provision of such authorizations to treatment
programs in the State; and
(B) the provision of interim maintenance
services in the State will not reduce the
capacity of comprehensive treatment programs in
the State to admit individuals to the programs
(relative to the date on which such officer so
certifies).
(4) Date certain for issuance of regulations;
failure of secretary.--The Secretary shall issue the
final rule for purposes of the regulations required in
paragraph (1), and such rule shall be effective, not
later than the expiration of the 180-day period
beginning on the date of the enactment of the ADAMHA
Reorganization Act \1\. If the Secretary fails to meet
the requirement of the preceding sentence, the proposed
rule issued on March 2, 1989, with respect to part 291
of title 21, Code of Federal Regulations (docket
numbered 88N-0444; 54 Fed. Reg. 8973 et seq.) is deemed
to take effect as a final rule upon the expiration of
such period, and the provisions of paragraph (3) of
this subsection are deemed to be incorporated into such
rule.
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\1\ Enacted July 10, 1992.
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(d) Definitions.--For purposes of this section:
(1) The term ``interim maintenance services'' means
the provision of methadone in a treatment program under
the circumstances described in paragraphs (1) and (2)
of subsection (a).
(2) The term ``HIV disease'' means infection with
the etiologic agent for acquired immune deficiency
syndrome.
(3) The term ``treatment program'' means a public
or nonprofit private program of treatment for
dependence on heroin or other morphine-like drugs.
TITLE XX--ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
findings and purposes
Sec. 2001. [300z] (a) The Congress finds that--
(1) in 1978, an estimated one million one hundred
thousand teenagers became pregnant, more than five
hundred thousand teenagers carried their babies to
term, and over one-half of the babies born to such
teenagers were born out of wedlock;
(2) adolescents aged seventeen and younger
accounted for more than one-half of the out of wedlock
births to teenagers;
(3) in a high proportion of cases, the pregnant
adolescent is herself the product of an unmarried
parenthood during adolescence and is continuing the
pattern in her own lifestyle;
(4) it is estimated that approximately 80 per
centum of unmarried teenagers who carry their
pregnancies to term live with their families before and
during their pregnancy and remain with their families
after the birth of the child;
(5) pregnancy and childbirth among unmarried
adolescents, particularly young adolescents, often
results in severe adverse health, social, and economic
consequences including: a higher percentage of
pregnancy and childbirth complications; a higher
incidence of low birth weight babies; a higher infant
mortality and morbidity; a greater likelihood that an
adolescent marriage will end in divorce; a decreased
likelihood of completing schooling; and higher risks of
unemployment and welfare dependency; and therefore,
education, training, and job research services are
important for adolescent parents;
(6)(A) adoption is a positive option for unmarried
pregnant adolescents who are unwilling or unable to
care for their children since adoption is a means of
providing permanent families for such children from
available approved couples who are unable or have
difficulty in conceiving or carrying children of their
own to term; and
(B) at present, only 4 per centum of unmarried
pregnant adolescents who carry their babies to term
enter into an adoption plan or arrange for their babies
to be cared for by relatives or friends;
(7) an unmarried adolescent who becomes pregnant
once is likely to experience recurrent pregnancies and
childbearing, with increased risks;
(8)(A) the problems of adolescent premarital sexual
relations, pregnancy, and parenthood are multiple and
complex and are frequently associated with or are a
cause of other troublesome situations in the family;
and
(B) such problems are best approached through a
variety of integrated and essential services provided
to adolescents and their families by other family
members, religious and charitable organizations,
voluntary associations, and other groups in the private
sector as well as services provided by publicly
sponsored initiatives;
(9) a wide array of educational, health, and
supportive services are not available to adolescents
with such problems or to their families, or when
available frequently are fragmented and thus are of
limited effectiveness in discouraging adolescent
premarital sexual relations and the consequences of
such relations;
(10)(A) prevention of adolescent sexual activity
and adolescent pregnancy depends primarily upon
developing strong family values and close family ties,
and since the family is the basic social unit in which
the values and attitudes of adolescents concerning
sexuality and pregnancy are formed, programs designed
to deal with issues of sexuality and pregnancy will be
successful to the extent that such programs encourage
and sustain the role of the family in dealing with
adolescent sexual activity and adolescent pregnancy;
(B) Federal policy therefore should encourage the
development of appropriate health, educational, and
social services where such services are now lacking or
inadequate, and the better coordination of existing
services where they are available; and
(C) services encouraged by the Federal Government
should promote the involvement of parents with their
adolescent children, and should emphasize the provision
of support by other family members, religious and
charitable organizations, voluntary associations, and
other groups in the private sector in order to help
adolescents and their families deal with complex issues
of adolescent premarital sexual relations and the
consequences of such relations; and
(11)(A) there has been limited research concerning
the societal causes and consequences of adolescent
pregnancy;
(B) there is limited knowledge concerning which
means of intervention are effective in mediating or
eliminating adolescent premarital sexual relations and
adolescent pregnancy; and
(C) it is necessary to expand and strengthen such
knowledge in order to develop an array of approaches to
solving the problems of adolescent premarital sexual
relations and adolescent pregnancy in both urban and
rural settings.
(b) Therefore, the purposes of this title are--
(1) to find effective means, within the context of
the family, of reaching adolescents before they become
sexually active in order to maximize the guidance and
support available to adolescents from parents and other
family members, and to promote self discipline and
other prudent approaches to the problem of adolescent
premarital sexual relations, including adolescent
pregnancy;
(2) to promote adoption as an alternative for
adolescent parents;
(3) to establish innovative, comprehensive, and
integrated approaches to the delivery of care services
both for pregnant adolescents, with primary emphasis on
unmarried adolescents who are seventeen years of age or
under, and for adolescent parents, which shall be based
upon an assessment of existing programs and, where
appropriate, upon efforts to establish better
coordination, integration, and linkages among such
existing programs in order to--
(A) enable pregnant adolescents to obtain
proper care and assist pregnant adolescents and
adolescent parents to become productive
independent contributors to family and
community life; and
(B) assist families of adolescents to
understand and resolve the societal causes
which are associated with adolescent pregnancy;
(4) to encourage and support research projects and
demonstration projects concerning the societal causes
and consequences of adolescent premarital sexual
relations, contraceptive use, pregnancy, and child
rearing;
(5) to support evaluative research to identify
effective services which alleviate, eliminate, or
resolve any negative consequences of adolescent
premarital sexual relations and adolescent childbearing
for the parents, the child, and their families; and
(6) to encourage and provide for the dissemination
of results, findings, and information from programs and
research projects relating to adolescent premarital
sexual relations, pregnancy, and parenthood.
definitions
Sec. 2002. [300z-1] (a) For the purposes of this title, the
term--
(1) ``Secretary'' means the Secretary of Health and
Human Services;
(2) ``eligible person'' means--
(A) with regard to the provision of care
services, a pregnant adolescent, an adolescent
parent, or the family of a pregnant adolescent
or an adolescent parent; or
(B) with regard to the provision of
prevention services and referral to such other
services which may be appropriate, a
nonpregnant adolescent;
(3) ``eligible grant recipient'' means a public or
nonprofit private organization or agency which
demonstrates, to the satisfaction of the Secretary--
(A) in the case of an organization which
will provide care services, the capability of
providing all care services in a single setting
or the capability of creating a network through
which all care services would be provided; or
(B) in the case of an organization which
will provide prevention services, the
capability of providing such services;
(4) ``necessary services'' means services which may
be provided by grantees which are--
(A) pregnancy testing and maternity
counseling;
(B) adoption counseling and referral
services which present adoption as an option
for pregnant adolescents, including referral to
licensed adoption agencies in the community if
the eligible grant recipient is not a licensed
adoption agency;
(C) primary and preventive health services
including prenatal and postnatal care;
(D) nutrition information and counseling;
(E) referral for screening and treatment of
venereal disease;
(F) referral to appropriate pediatric care;
(G) educational services relating to family
life and problems associated with adolescent
premarital sexual relations, including--
(i) information about adoption;
(ii) education on the
responsibilities of sexuality and
parenting;
(iii) the development of material
to support the role of parents as the
provider of sex education; and
(iv) assistance to parents,
schools, youth agencies, and health
providers to educate adolescents and
preadolescents concerning self-
discipline and responsibility in human
sexuality;
(H) appropriate educational and vocational
services;
(I) referral to licensed residential care
or maternity home services; and
(J) mental health services and referral to
mental health services and to other appropriate
physical health services;
(K) child care sufficient to enable the
adolescent parent to continue education or to
enter into employment;
(L) consumer education and homemaking;
(M) counseling for the immediate and
extended family members of the eligible person;
(N) transportation;
(O) outreach services to families of
adolescents to discourage sexual relations
among unemancipated minors;
(P) family planning services; and
(Q) such other services consistent with the
purposes of this title as the Secretary may
approve in accordance with regulations
promulgated by the Secretary;
(5) ``core services'' means those services which
shall be provided by a grantee, as determined by the
Secretary by regulation;
(6) ``supplemental services'' means those services
which may be provided by a grantee, as determined by
the Secretary by regulation;
(7) ``care services'' means necessary services for
the provision of care to pregnant adolescents and
adolescent parents and includes all core services with
respect to the provision of such care prescribed by the
Secretary by regulation;
(8) ``prevention services'' means necessary
services to prevent adolescent sexual relations,
including the services described in subparagraphs (A),
(D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph
(4);
(9) ``adolescent'' means an individual under the
age of nineteen; and
(10) ``unemancipated minor'' means a minor who is
subject to the control, authority, and supervision of
his or her parents or guardians, as determined under
State law.
(b) Until such time as the Secretary promulgates
regulations pursuant to the second sentence of this subsection,
the Secretary shall use the regulations promulgated under title
VI of the Health Services and Centers Amendments of 1978 which
were in effect on the date of enactment of this title, to
determine which necessary services are core services for
purposes of this title. The Secretary may promulgate
regulations to determine which necessary services are core
services for purposes of this title based upon an evaluation of
and information concerning which necessary services are
essential to carry out the purposes of this title and taking
into account (1) factors such as whether services are to be
provided in urban or rural areas, the ethnic groups to be
served, and the nature of the populations to be served, and (2)
the results of the evaluations required under section 2006(b).
The Secretary may from time to time revise such regulations.
authority to make grants for demonstration projects
Sec. 2003. [300z-2] (a) The Secretary may make grants to
further the purposes of this title to eligible grant recipients
which have submitted an application which the Secretary finds
meets the requirements of section 2006 for demonstration
projects which the Secretary determines will help communities
provide appropriate care and prevention services in easily
accessible locations. Demonstration projects shall, as
appropriate, provide, supplement, or improve the quality of
such services. Demonstration projects shall use such methods as
will strengthen the capacity of families to deal with the
sexual behavior, pregnancy, or parenthood of adolescents and to
make use of support systems such as other family members,
friends, religious and charitable organizations, and voluntary
associations.
(b) Grants under this title for demonstration projects may
be for the provision of--
(1) care services;
(2) prevention services; or
(3) a combination of care services and prevention
services.
uses of grants for demonstration projects for services
Sec. 2004. [300z-3] (a) Except as provided in subsection
(b), funds provided for demonstration projects for services
under this title may be used by grantees only to--
(1) provide to eligible persons--
(A) care services;
(B) prevention services; or
(C) care and prevention services (in the
case of a grantee who is providing a
combination of care and prevention services);
(2) coordinate, integrate, and provide linkages
among providers of care, prevention, and other services
for eligible persons in furtherance of the purposes of
this title;
(3) provide supplemental services where such
services are not adequate or not available to eligible
persons in the community and which are essential to the
care of pregnant adolescents and to the prevention of
adolescent premarital sexual relations and adolescent
pregnancy;
(4) plan for the administration and coordination of
pregnancy prevention services and programs of care for
pregnant adolescents and adolescent parents which will
further the objectives of this title; and
(5) fulfill assurances required for grant approval
by section 2006.
(b)(1) No funds provided for a demonstration project for
services under this title may be used for the provision of
family planning services (other than counseling and referral
services) to adolescents unless appropriate family planning
services are not otherwise available in the community.
(2) Any grantee who receives funds for a demonstration
project for services under this title and who, after
determining under paragraph (1) that appropriate family
planning services are not otherwise available in the community,
provides family planning services (other than counseling and
referral services) to adolescents may only use funds provided
under this title for such family planning services if all funds
received by such grantee from all other sources to support such
family planning services are insufficient to support such
family planning services.
(c) Grantees who receive funds for a demonstration project
for services under this title shall charge fees for services
pursuant to a fee schedule approved by the Secretary as a part
of the application described in section 2006 which bases fees
charged by the grantee on the income of the eligible person or
the parents or legal guardians of the eligible person and takes
into account the difficulty adolescents face in obtaining
resources to pay for services. A grantee who receives funds for
a demonstration project for services under this title may not,
in any case, discriminate with regard to the provision of
services to any individual because of that individual's
inability to provide payment for such services, except that in
determining the ability of an unemancipated minor to provide
payment for services, the income of the family of an
unemancipated minor shall be considered in determining the
ability of such minor to make such payments unless the parents
or guardians of the unemancipated minor refuse to make such
payments.
priorities, amounts, and duration of grants for demonstration projects
for services
Sec. 2005. [300z-4] (a) In approving applications for
grants for demonstration projects for services under this
title, the Secretary shall give priority to applicants who--
(1) serve an area where there is a high incidence
of adolescent pregnancy;
(2) serve an area with a high proportion of low-
income families and where the availability of programs
of care for pregnant adolescents and adolescent parents
is low;
(3) show evidence--
(A) in the case of an applicant who will
provide care services, of having the ability to
bring together a wide range of needed core
services and, as appropriate, supplemental
services in comprehensive single-site projects,
or to establish a well-integrated network of
such services (appropriate for the target
population and geographic area to be served
including the special needs of rural areas) for
pregnant adolescents or adolescent parents; or
(B) in the case of an applicant who will
provide prevention services, of having the
ability to provide prevention services for
adolescents and their families which are
appropriate for the target population and the
geographic area to be served, including the
special needs of rural areas;
(4) will utilize to the maximum extent feasible
existing available programs and facilities such as
neighborhood and primary health care centers, maternity
homes which provide or can be equipped to provide
services to pregnant adolescents, agencies serving
families, youth, and children with established programs
of service to pregnant adolescents and vulnerable
families, licensed adoption agencies, children and
youth centers, maternal and infant health centers,
regional rural health facilities, school and other
educational programs, mental health programs, nutrition
programs, recreation programs, and other ongoing
pregnancy prevention services and programs of care for
pregnant adolescents and adolescent parents;
(5) make use, to the maximum extent feasible, of
other Federal, State, and local funds, programs,
contributions, and other third-party reimbursements;
(6) can demonstrate a community commitment to the
program by making available to the demonstration
project non-Federal funds, personnel, and facilities;
(7) have involved the community to be served,
including public and private agencies, adolescents, and
families, in the planning and implementation of the
demonstration project; and
(8) will demonstrate innovative and effective
approaches in addressing the problems of adolescent
premarital sexual relations, pregnancy, or parenthood,
including approaches to provide pregnant adolescents
with adequate information about adoption.
(b)(1) The amount of a grant for a demonstration project
for services under this title shall be determined by the
Secretary, based on factors such as the incidence of adolescent
pregnancy in the geographic area to be served, and the adequacy
of pregnancy prevention services and programs of care for
pregnant adolescents and adolescent parents in such area.
(2) In making grants for demonstration projects for
services under this title, the Secretary shall consider the
special needs of rural areas and, to the maximum extent
practicable, shall distribute funds taking into consideration
the relative number of adolescents in such areas in need of
such services.
(c)(1) A grantee may not receive funds for a demonstration
project for services under this title for a period in excess of
5 years.
(2)(A) Subject to paragraph (3), a grant for a
demonstration project for services under this title may not
exceed--
(i) 70 per centum of the costs of the project for
the first and second years of the project;
(ii) 60 per centum of such costs for the third year
of the project;
(iii) 50 per centum of such costs for the fourth
year of the project; and
(iv) 40 per centum of such costs for the fifth year
of the project.
(B) Non-Federal contributions required by subparagraph (A)
may be in cash or in kind, fairly evaluated, including plant,
equipment, or services.
(3) The Secretary may waive the limitation specified in
paragraph (2)(A) for any year in accordance with criteria
established by regulation.
requirements for applications
Sec. 2006. [300z-5] (a) An application for a grant for a
demonstration project for services under this title shall be in
such form and contain such information as the Secretary may
require, and shall include--
(1) an identification of the incidence of
adolescent pregnancy and related problems;
(2) a description of the economic conditions and
income levels in the geographic area to be served;
(3) a description of existing pregnancy prevention
services and programs of care for pregnant adolescents
and adolescent parents (including adoption services),
and including where, how, by whom, and to which
population groups such services are provided, and the
extent to which they are coordinated in the geographic
area to be served;
(4) a description of the major unmet needs for
services for adolescents at risk of initial or
recurrent pregnancies and an estimate of the number of
adolescents not being served in the area;
(5)(A) in the case of an applicant who will provide
care services, a description of how all core services
will be provided in the demonstration project using
funds under this title or will otherwise be provided by
the grantee in the area to be served, the population to
which such services will be provided, how such services
will be coordinated, integrated, and linked with other
related programs and services and the source or sources
of funding of such core services in the public and
private sectors; or
(B) in the case of an applicant who will provide
prevention services, a description of the necessary
services to be provided and how the applicant will
provide such services;
(6) a description of the manner in which
adolescents needing services other than the services
provided directly by the applicant will be identified
and how access and appropriate referral to such other
services (such as medicaid; licensed adoption agencies;
maternity home services; public assistance; employment
services; child care services for adolescent parents;
and other city, county, and State programs related to
adolescent pregnancy) will be provided, including a
description of a plan to coordinate such other services
with the services supported under this title;
(7) a description of the applicant's capacity to
continue services as Federal funds decrease and in the
absence of Federal assistance;
(8) a description of the results expected from the
provision of services, and the procedures to be used
for evaluating those results;
(9) a summary of the views of public agencies,
providers of services, and the general public in the
geographic area to be served, concerning the proposed
use of funds provided for a demonstration project for
services under this title and a description of
procedures used to obtain those views, and, in the case
of applicants who propose to coordinate services
administered by a State, the written comments of the
appropriate State officials responsible for such
services;
(10) assurances that the applicant will have an
ongoing quality assurance program;
(11) assurances that, where appropriate, the
applicant shall have a system for maintaining the
confidentiality of patient records in accordance with
regulations promulgated by the Secretary;
(12) assurances that the applicant will demonstrate
its financial responsibility by the use of such
accounting procedures and other requirements as may be
prescribed by the Secretary;
(13) assurances that the applicant (A) has or will
have a contractual or other arrangement with the agency
of the State (in which the applicant provides services)
that administers or supervises the administration of a
State plan approved under title XIX of the Social
Security Act for the payment of all or a part of the
applicant's costs in providing health services to
persons who are eligible for medical assistance under
such a State plan, or (B) has made or will make every
reasonable effort to enter into such an arrangement;
(14) assurances that the applicant has made or will
make and will continue to make every reasonable effort
to collect appropriate reimbursement for its costs in
providing health services to persons who are entitled
to benefits under title V of the Social Security Act,
to medical assistance under a State plan approved under
title XIX of such Act, or to assistance for medical
expenses under any other public assistance program or
private health insurance program;
(15) assurances that the applicant has or will make
and will continue to make every reasonable effort to
collect appropriate reimbursement for its costs in
providing services to persons entitled to services
under parts B and E of title IV and title XX of the
Social Security Act;
(16)(A) a description of--
(i) the schedule of fees to be used in the
provision of services, which shall comply with
section 2004(c) and which shall be designed to
cover all reasonable direct and indirect costs
incurred by the applicant in providing
services; and
(ii) a corresponding schedule of discounts
to be applied to the payment of such fees,
which shall comply with section 2004(c) and
which shall be adjusted on the basis of the
ability of the eligible person to pay;
(B) assurances that the applicant has made and will
continue to make every reasonable effort--
(i) to secure from eligible persons payment
for services in accordance with such schedules;
(ii) to collect reimbursement for health or
other services provided to persons who are
entitled to have payment made on their behalf
for such services under any Federal or other
government program or private insurance
program; and
(iii) to seek such reimbursement on the
basis of the full amount of fees for services
without application of any discount; and
(C) assurances that the applicant has submitted or
will submit to the Secretary such reports as the
Secretary may require to determine compliance with this
paragraph;
(17) assurances that the applicant will make
maximum use of funds available under title X of this
Act;
(18) assurances that the acceptance by any
individual of family planning services or family
planning information (including educational materials)
provided through financial assistance under this title
shall be voluntary and shall not be a prerequisite to
eligibility for or receipt of any other service
furnished by the applicant;
(19) assurances that fees collected by the
applicant for services rendered in accordance with this
title shall be used by the applicant to further the
purposes of this title;
(20) assurances that the applicant, if providing
both prevention and care services will not exclude or
discriminate against any adolescent who receives
prevention services and subsequently requires care
services as a pregnant adolescent;
(21) a description of how the applicant will, as
appropriate in the provision of services--
(A) involve families of adolescents in a
manner which will maximize the role of the
family in the solution of problems relating to
the parenthood or pregnancy of the adolescent;
(B) involve religious and charitable
organizations, voluntary associations, and
other groups in the private sector as well as
services provided by publicly sponsored
initiatives;
(22)(A) assurances that--
(i) except as provided in subparagraph (B)
and subject to clause (ii), the applicant will
notify the parents or guardians of any
unemancipated minor requesting services from
the applicant and, except as provided in
subparagraph (C), will obtain the permission of
such parents or guardians with respect to the
provision of such services; and
(ii) in the case of a pregnant
unemancipated minor requesting services from
the applicant, the applicant will notify the
parents or guardians of such minor under clause
(i) within a reasonable period of time;
(B) assurances that the applicant will not notify
or request the permission of the parents or guardian of
any unemancipated minor without the consent of the
minor--
(i) who solely is requesting from the
applicant pregnancy testing or testing or
treatment for venereal disease;
(ii) who is the victim of incest involving
a parent; or
(iii) if an adult sibling of the minor or
an adult aunt, uncle, or grandparent who is
related to the minor by blood certifies to the
grantee that notification of the parents or
guardians of such minor would result in
physical injury to such minor; and
(C) assurances that the applicant will not require,
with respect to the provision of services, the
permission of the parents or guardians of any pregnant
unemancipated minor if such parents or guardians are
attempting to compel such minor to have an abortion;
(23) assurances that primary emphasis for services
supported under this title shall be given to
adolescents seventeen and under who are not able to
obtain needed assistance through other means;
(24) assurances that funds received under this
title shall supplement and not supplant funds received
from any other Federal, State, or local program or any
private sources of funds; and
(25) a plan for the conduct of, and assurances that
the applicant will conduct, evaluations of the
effectiveness of the services supported under this
title in accordance with subsection (b).
(b)(1) Each grantee which receives funds for a
demonstration project for services under this title shall
expend at least 1 per centum but not in excess of 5 per centum
of the amounts received under this title for the conduct of
evaluations of the services supported under this title. The
Secretary may, for a particular grantee upon good cause shown,
waive the provisions of the preceding sentence with respect to
the amounts to be expended on evaluations, but may not waive
the requirement that such evaluations be conducted.
(2) Evaluations required by paragraph (1) shall be
conducted by an organization or entity which is independent of
the grantee providing services supported under this title. To
assist in conducting the evaluations required by paragraph (1),
each grantee shall develop a working relationship with a
college or university located in the grantee's State which will
provide or assist in providing monitoring and evaluation of
services supported under this title unless no college or
university in the grantee's State is willing or has the
capacity to provide or assist in providing such monitoring and
assistance.
(3) The Secretary may provide technical assistance with
respect to the conduct of evaluations required under this
subsection to any grantee which is unable to develop a working
relationship with a college or university in the applicant's
State for the reasons described in paragraph (2).
(c) Each grantee which receives funds for a demonstration
project for services under this title shall make such reports
concerning its use of Federal funds as the Secretary may
require. Reports shall include, at such times as are considered
appropriate by the Secretary, the results of the evaluations of
the services supported under this title.
(d)(1) A grantee shall periodically notify the Secretary of
the exact number of instances in which a grantee does not
notify the parents or guardians of a pregnant unemancipated
minor under subsection (a)(22)(B)(iii).
(2) For purposes of subsection (a)(22)(B)(iii), the term
``adult'' means an adult as defined by State law.
(e) Each applicant shall provide the Governor of the State
in which the applicant is located a copy of each application
submitted to the Secretary for a grant for a demonstration
project for services under this title. The Governor shall
submit to the applicant comments on any such application within
the period of sixty days beginning on the day when the Governor
receives such copy. The applicant shall include the comments of
the Governor with such application.
(f) No application submitted for a grant for a
demonstration project for care services under this title may be
approved unless the Secretary is satisfied that core services
shall be available through the applicant within a reasonable
time after such grant is received.
coordination of federal and state programs
Sec. 2007. [300z-6] (a) The Secretary shall coordinate
Federal policies and programs providing services relating to
the prevention of adolescent sexual relations and initial and
recurrent adolescent pregnancies and providing care services
for pregnant adolescents. In achieving such coordination, the
Secretary shall--
(1) require grantees who receive funds for
demonstration projects for services under this title to
report periodically to the Secretary concerning
Federal, State, and local policies and programs that
interfere with the delivery of and coordination of
pregnancy prevention services and other programs of
care for pregnant adolescents and adolescent parents;
(2) provide technical assistance to facilitate
coordination by State and local recipients of Federal
assistance;
(3) review all programs administered by the
Department of Health and Human Services which provide
prevention services or care services to determine if
the policies of such programs are consistent with the
policies of this title, consult with other departments
and agencies of the Federal Government who administer
programs that provide such services, and encourage such
other departments and agencies to make recommendations,
as appropriate, for legislation to modify such programs
in order to facilitate the use of all Government
programs which provide such services as a basis for
delivery of more comprehensive prevention services and
more comprehensive programs of care for pregnant
adolescents and adolescent parents;
(4) give priority in the provision of funds, where
appropriate, to applicants using single or coordinated
grant applications for multiple programs; and
(5) give priority, where appropriate, to the
provision of funds under Federal programs administered
by the Secretary (other than the program established by
this title) to projects providing comprehensive
prevention services and comprehensive programs of care
for pregnant adolescents and adolescent parents.
(b) Any recipient of a grant for a demonstration project
for services under this title shall coordinate its activities
with any other recipient of such a grant which is located in
the same locality.
research
Sec. 2008. [300z-7] (a)(1) The Secretary may make grants
and enter into contracts with public agencies or private
organizations or institutions of higher education to support
the research and dissemination activities described in
paragraphs (4), (5), and (6) of section 2001(b).
(2) The Secretary may make grants or enter into contracts
under this section for a period of one year. A grant or
contract under this section for a project may be renewed for
four additional one-year periods, which need not be
consecutive.
(3) A grant or contract for any one-year period under this
section may not exceed $100,000 for the direct costs of
conducting research or disemination \1\ activities under this
section and may include such additional amounts for the
indirect costs of conducting such activities as the Secretary
determines appropriate. The Secretary may waive the preceding
sentence with respect to a specific project if he determines
that--
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``dissemination''.
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(A) exceptional circumstances warrant such waiver
and that the project will have national impact; or
(B) additional amounts are necessary for the direct
costs of conducting limited demonstration projects for
the provision of necessary services in order to provide
data for research carried out under this title.
(4) The amount of any grant or contract made under this
section may remain available for obligation or expenditure
after the close of the one-year period for which such grant or
contract is made in order to assist the recipient in preparing
the report required by subsection (f)(1).
(b)(1) Funds provided for research under this section may
be used for descriptive or explanatory surveys, longitudinal
studies, or limited demonstration projects for services that
are for the purpose of increasing knowledge and understanding
of the matters described in paragraphs (4) and (5) of section
2001(b).
(2) Funds provided under this section may not be used for
the purchase or improvement of land, or the purchase,
construction, or permanent improvement (other than minor
remodeling) of any building or facility.
(c) The Secretary may not make any grant or enter into any
contract to support research or dissemination activities under
this section unless--
(1) the Secretary has received an application for
such grant or contract which is in such form and which
contains such information as the Secretary may by
regulation require;
(2) the applicant has demonstrated that the
applicant is capable of conducting one or more of the
types of research or dissemination activities described
in paragraph (4), (5), or (6) of section 2001(b); and
(3) in the case of an application for a research
project, the panel established by subsection (e)(2) has
determined that the project is of scientific merit.
(d) The Secretary shall, where appropriate, coordinate
research and dissemination activities carried out under this
section with research and dissemination activities carried out
by the National Institutes of Health.
(e)(1) The Secretary shall establish a system for the
review of applications for grants and contracts under this
section. Such system shall be substantially similar to the
system for scientific peer review of the National Institutes of
Health and shall meet the requirements of paragraphs (2) and
(3).
(2) In establishing the system required by paragraph (1),
the Secretary shall establish a panel to review applications
under this section. Not more than 25 per centum of the members
of the panel shall be physicians. The panel shall meet as often
as may be necessary to facilitate the expeditious review of
applications under this section, but not less than once each
year. The panel shall review each project for which an
application is made under this section, evaluate the scientific
merit of the project, determine whether the project is of
scientific merit, and make recommendations to the Secretary
concerning whether the application for the project should be
approved.
(3) The Secretary shall make grants under this section from
among the projects which the panel established by paragraph (2)
has determined to be of scientific merit and may only approve
an application for a project if the panel has made such
determination with respect to such a project. The Secretary
shall make a determination with respect to an application
within one month after receiving the determinations and
recommendations of such panel with respect to the application.
(f)(1)(A) The recipient of a grant or contract for a
research project under this section shall prepare and transmit
to the Secretary a report describing the results and
conclusions of such research. Except as provided in
subparagraph (B), such report shall be transmitted to the
Secretary not later than eighteen months after the end of the
year for which funds are provided under this section. The
recipient may utilize reprints of articles published or
accepted for publication in professional journals to supplement
or replace such report if the research contained in such
articles was supported under this section during the year for
which the report is required.
(B) In the case of any research project for which
assistance is provided under this section for two or more
consecutive one-year periods, the recipient of such assistance
shall prepare and transmit the report required by subparagraph
(A) to the Secretary not later than twelve months after the end
of each one-year period for which such funding is provided.
(2) Recipients of grants and contracts for dissemination
under this section shall submit to the Secretary such reports
as the Secretary determines appropriate.
evaluation and administration
Sec. 2009. [300z-8] (a) Of the funds appropriated under
this title, the Secretary shall reserve not less than 1 per
centum and not more than 3 per centum for the evaluation of
activities carried out under this title. The Secretary shall
submit to the appropriate committees of the Congress a summary
of each evaluation conducted under this section.
(b) The officer or employee of the Department of Health and
Human Services designated by the Secretary to carry out the
provisions of this title shall report directly to the Assistant
Secretary for Health with respect to the activities of such
officer or employee in carrying out such provisions.
authorization of appropriations
Sec. 2010. [300z-9] (a) For the purpose of carrying out
this title, there are authorized to be appropriated $30,000,000
for the fiscal year ending September 30, 1982, $30,000,000 for
the fiscal year ending September 30, 1983, $30,000,000 for the
fiscal year ending September 30, 1984, and $30,000,000 for the
fiscal year ending September 30, 1985.
(b) At least two-thirds of the amounts appropriated to
carry out this title shall be used to make grants for
demonstration projects for services.
(c) Not more than one-third of the amounts specified under
subsection (b) for use for grants for demonstration projects
for services shall be used for grants for demonstration
projects for prevention services.
restrictions
Sec. 2011. [300z-10] (a) Grants or payments may be made
only to programs or projects which do not provide abortions or
abortion counseling or referral, or which do not subcontract
with or make any payment to any person who provides abortions
or abortion counseling or referral, except that any such
program or project may provide referral for abortion counseling
to a pregnant adolescent if such adolescent and the parents or
guardians of such adolescent request such referral; and grants
may be made only to projects or programs which do not advocate,
promote, or encourage abortion.
(b) The Secretary shall ascertain whether programs or
projects comply with subsection (a) and take appropriate action
if programs or projects do not comply with such subsection,
including withholding of funds.ATTORNEY: PMG/FD (June
22, 1999) deg.
TITLE XXI--VACCINES
Subtitle 1--National Vaccine Program
establishment
Sec. 2101. [300aa-1] The Secretary shall establish in the
Department of Health and Human Services a National Vaccine
Program to achieve optimal prevention of human infectious
diseases through immunization and to achieve optimal prevention
against adverse reactions to vaccines. The Program shall be
administered by a Director selected by the Secretary.
program responsibilities
Sec. 2102. [300aa-2] (a) The Director of the Program shall
have the following responsibilities:
(1) Vaccine research.--The Director of the Program
shall, through the plan issued under section 2103,
coordinate and provide direction for research carried
out in or through the National Institutes of Health,
the Centers for Disease Control and Prevention, the
Office of Biologics Research and Review of the Food and
Drug Administration, the Department of Defense, and the
Agency for International Development on means to induce
human immunity against naturally occurring infectious
diseases and to prevent adverse reactions to vaccines.
(2) Vaccine development.--The Director of the
Program shall, through the plan issued under section
2103, coordinate and provide direction for activities
carried out in or through the National Institutes of
Health, the Office of Biologics Research and Review of
the Food and Drug Administration, the Department of
Defense, and the Agency for International Development
to develop the techniques needed to produce safe and
effective vaccines.
(3) Safety and efficacy testing of vaccines.--The
Director of the Program shall, through the plan issued
under section 2103, coordinate and provide direction
for safety and efficacy testing of vaccines carried out
in or through the National Institutes of Health, the
Centers for Disease Control and Prevention, the Office
of Biologics Research and Review of the Food and Drug
Administration, the Department of Defense, and the
Agency for International Development.
(4) Licensing of vaccine manufacturers and
vaccines.--The Director of the Program shall, through
the plan issued under section 2103, coordinate and
provide direction for the allocation of resources in
the implementation of the licensing program under
section 353.
(5) Production and procurement of vaccines.--The
Director of the Program shall, through the plan issued
under section 2103, ensure that the governmental and
non-governmental production and procurement of safe and
effective vaccines by the Public Health Service, the
Department of Defense, and the Agency for International
Development meet the needs of the United States
population and fulfill commitments of the United States
to prevent human infectious diseases in other
countries.
(6) Distribution and use of vaccines.--The Director
of the Program shall, through the plan issued under
section 2103, coordinate and provide direction to the
Centers for Disease Control and Prevention and
assistance to States, localities, and health
practitioners in the distribution and use of vaccines,
including efforts to encourage public acceptance of
immunizations and to make health practitioners and the
public aware of potential adverse reactions and
contraindications to vaccines.
(7) Evaluating the need for and the effectiveness
and adverse effects of vaccines and immunization
activities.--The Director of the Program shall, through
the plan issued under section 2103, coordinate and
provide direction to the National Institutes of Health,
the Centers for Disease Control and Prevention, the
Office of Biologics Research and Review of the Food and
Drug Administration, the National Center for Health
Statistics, the National Center for Health Services
Research and Health Care Technology Assessment, and the
Centers for Medicare & Medicaid Services in monitoring
the need for and the effectiveness and adverse effects
of vaccines and immunization activities.
(8) Coordinating governmental and non-governmental
activities.--The Director of the Program shall, through
the plan issued under section 2103, provide for the
exchange of information between Federal agencies
involved in the implementation of the Program and non-
governmental entities engaged in the development and
production of vaccines and in vaccine research and
encourage the investment of non-governmental resources
complementary to the governmental activities under the
Program.
(9) Funding of federal agencies.--The Director of
the Program shall make available to Federal agencies
involved in the implementation of the plan issued under
section 2103 funds appropriated under section 2106 to
supplement the funds otherwise available to such
agencies for activities under the plan.
(b) In carrying out subsection (a) and in preparing the
plan under section 2103, the Director shall consult with all
Federal agencies involved in research on and development,
testing, licensing, production, procurement, distribution, and
use of vaccines.
plan
Sec. 2103. [300aa-3] The Director of the Program shall
prepare and issue a plan for the implementation of the
responsibilities of the Director under section 2102. The plan
shall establish priorities in research and the development,
testing, licensing, production, procurement, distribution, and
effective use of vaccines, describe an optimal use of resources
to carry out such priorities, and describe how each of the
various departments and agencies will carry out their vaccine
functions in consultation and coordination with the Program and
in conformity with such priorities. The first plan under this
section shall be prepared not later than January 1, 1987, and
shall be revised not later than January 1 of each succeeding
year.
national vaccine advisory committee
Sec. 2105. \1\ [300aa-5] (a) There is established the
National Vaccine Advisory Committee. The members of the
Committee shall be appointed by the Director of the Program, in
consultation with the National Academy of Sciences, from among
individuals who are engaged in vaccine research or the
manufacture of vaccines or who are physicians, members of
parent organizations concerned with immunizations, or
representatives of State or local health agencies or public
health organizations.
(b) The Committee shall--
(1) study and recommend ways to encourage the
availability of an adequate supply of safe and
effective vaccination products in the States,
(2) recommend research priorities and other
measures the Director of the Program should take to
enhance the safety and efficacy of vaccines,
(3) advise the Director of the Program in the
implementation of sections 2102, 2103, and 2104 \1\,
and
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\1\ Section 2104 was repealed by section 601(a)(1)(H) of Public Law
105-362.
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(4) identify annually for the Director of the
Program the most important areas of government and non-
government cooperation that should be considered in
implementing sections 2102, 2103, and 2104 \1\.
authorizations
Sec. 2106. [300aa-6] (a) To carry out this subtitle other
than section 2102(9) there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2004
and 2005.
(b) To carry out section 2102(9) there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2004 and 2005.
Subtitle 2--National Vaccine Injury Compensation Program
Part A--Program Requirements
establishment of program
Sec. 2110. [300aa-10] (a) Program Established.--There is
established the National Vaccine Injury Compensation Program to
be administered by the Secretary under which compensation may
be paid for a vaccine-related injury or death.
(b) Attorney's Obligation.--It shall be the ethical
obligation of any attorney who is consulted by an individual
with respect to a vaccine-related injury or death to advise
such individual that compensation may be available under the
program for such injury or death.
(c) Publicity.--The Secretary shall undertake reasonable
efforts to inform the public of the availability of the
Program.
petitions for compensation
Sec. 2111. [300aa-11] (a) General Rule.--
(1) A proceeding for compensation under the Program
for a vaccine-related injury or death shall be
initiated by service upon the Secretary and the filing
of a petition containing the matter prescribed by
subsection (c) with the United States Claims Court. The
clerk of the United States Claims Court shall
immediately forward the filed petition to the chief
special master for assignment to a special master under
section 2112(d)(1).
(2)(A) No person may bring a civil action for
damages in an amount greater than $1,000 or in an
unspecified amount against a vaccine administrator or
manufacturer in a State or Federal court for damages
arising from a vaccine-related injury or death
associated with the administration of a vaccine after
the effective date of this part, and no such court may
award damages in an amount greater than $1,000 in a
civil action for damages for such a vaccine-related
injury or death,
unless a petition has been filed, in accordance with
section 2116, for compensation under the Program for
such injury or death and--
(i)(I) the United States Claims Court has
issued a judgment under section 2112 on such
petition, and
(II) such person elects under section 2121(a) to
file such an action, or
(ii) such person elects to withdraw such
petition under section 2121(b) or such petition
is considered withdrawn under such section.
(B) If a civil action which is barred under
subparagraph (A) is filed in a State or Federal court,
the court shall dismiss the action. If a petition is
filed under this section with respect to the injury or
death for which such civil action was brought, the date
such dismissed action was filed shall, for purposes of
the limitations of actions prescribed by section 2116,
be considered the date the petition was filed if the
petition was filed within one year of the date of the
dismissal of the civil action.
(3) No vaccine administrator or manufacturer may be
made a party to a civil action (other than a civil
action which may be brought under paragraph (2)) for
damages for a vaccine-related injury or death
associated with the administration of a vaccine after
the effective date of this part. \1\
(4) If in a civil action brought against a vaccine
administrator or manufacturer before the effective date
of this part \1\ damages were denied for a vaccine-
related injury or death or if such civil action was
dismissed with prejudice, the person who brought such
action may file a petition under subsection (b) for
such injury or death.
(5)(A) A plaintiff who on the effective date of
this part \1\ has pending a civil action for damages
for a vaccine-related injury or death may, at any time
within 2 years after the effective date of this part
\1\ or before judgment, whichever occurs first,
petition to have such action dismissed without
prejudice or costs and file a petition under subsection
(b) for such injury or death.
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\1\ Effective October 1, 1988.
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(B) If a plaintiff has pending a civil action for
damages for a vaccine-related injury or death, such
person may not file a petition under subsection (b) for
such injury or death.
(6) If a person brings a civil action after
November 15, 1988 \2\ for damages for a vaccine-related
injury or death associated with the administration of a
vaccine before November 15, 1988, such person may not
file a petition under subsection (b) for such injury or
death.
---------------------------------------------------------------------------
\2\ So in law. Probably should be followed by a comma.
---------------------------------------------------------------------------
(7) If in a civil action brought against a vaccine
administrator or manufacturer for a vaccine-related
injury or death damages are awarded under a judgment of
a court or a settlement of such action, the person who
brought such action may not file a petition under
subsection (b) for such injury or death.
(8) If on the effective date of this part there was
pending an appeal or rehearing with respect to a civil
action brought against a vaccine administrator or
manufacturer and if the outcome of the last appellate
review of such action or the last rehearing of such
action is the denial of damages for a vaccine-related
injury or death, the person who brought such action may
file a petition under subsection (b) for such injury or
death.
(9) This subsection applies only to a person who
has sustained a vaccine-related injury or death and who
is qualified to file a petition for compensation under
the Program.
(10) The Clerk of the United States Claims Court is
authorized to continue to receive, and forward,
petitions for compensation for a vaccine-related injury
or death associated with the administration of a
vaccine on or after October 1, 1992.
(b) Petitioners.--
(1)(A) Except as provided in subparagraph (B), any
person who has sustained a vaccine-related injury, the
legal representative of such person if such person is a
minor or is disabled, or the legal representative of
any person who died as the result of the administration
of a vaccine set forth in the Vaccine Injury Table may,
if the person meets the requirements of subsection
(c)(1), file a petition for compensation under the
Program.
(B) No person may file a petition for a vaccine-
related injury or death associated with a vaccine
administered before the effective date of this part if
compensation has been paid under this subtitle for 3500
petitions for such injuries or deaths.
(2) Only one petition may be filed with respect to
each administration of a vaccine.
(c) Petition Content.--A petition for compensation under
the Program for a vaccine-related injury or death shall
contain--
(1) except as provided in paragraph (3), an
affidavit, and supporting documentation, demonstrating
that the person who suffered such injury or who died--
(A) received a vaccine set forth in the
Vaccine Injury Table or, if such person did not
receive such a vaccine, contracted polio,
directly or indirectly, from another person who
received an oral polio vaccine,
(B)(i) if such person received a vaccine
set forth in the Vaccine Injury Table--
(I) received the vaccine in the
United States or in its trust
territories,
(II) received the vaccine outside
the United States or a trust territory
and at the time of the vaccination such
person was a citizen of the United
States serving abroad as a member of
the Armed Forces or otherwise as an
employee of the United States or a
dependent of such a citizen, or
(III) received the vaccine outside
the United States or a trust territory
and the vaccine was manufactured by a
vaccine manufacturer located in the
United States and such person returned
to the United States not later than 6
months after the date of the
vaccination,
(ii) if such person did not receive such a
vaccine but contracted polio from another
person who received an oral polio vaccine, was
a citizen of the United States or a dependent
of such a citizen,
(C)(i) sustained, or had significantly
aggravated, any illness, disability, injury, or
condition set forth in the Vaccine Injury Table
in association with the vaccine referred to in
subparagraph (A) or died from the
administration of such vaccine, and the first
symptom or manifestation of the onset or of the
significant aggravation of any such illness,
disability, injury, or condition or the death
occurred within the time period after vaccine
administration set forth in the Vaccine Injury
Table, or
(ii)(I) sustained, or had significantly
aggravated, any illness, disability, injury, or
condition not set forth in the Vaccine Injury
Table but which was caused by a vaccine
referred to in subparagraph (A), or
(II) sustained, or had significantly
aggravated, any illness, disability, injury, or
condition set forth in the Vaccine Injury Table
the first symptom or manifestation of the onset
or significant aggravation of which did not
occur within the time period set forth in the
Table but which was caused by a vaccine
referred to in subparagraph (A),
(D)(i) suffered the residual effects or
complications of such illness, disability,
injury, or condition for more than 6 months
after the administration of the vaccine, or
(ii) died from the administration of the
vaccine, or (iii) suffered such illness,
disability, injury, or condition from the
vaccine which resulted in inpatient
hospitalization and surgical intervention, and
(E) has not previously collected an award
or settlement of a civil action for damages for
such vaccine-related injury or death,
(2) except as provided in paragraph (3), maternal
prenatal and delivery records, newborn hospital records
(including all physicians' and nurses' notes and test
results), vaccination records associated with the
vaccine allegedly causing the injury, pre- and post-
injury physician or clinic records (including all
relevant growth charts and test results), all post-
injury inpatient and outpatient records (including all
provider notes, test results, and medication records),
if applicable, a death certificate, and if applicable,
autopsy results, and
(3) an identification of any records of the type
described in paragraph (1) or (2) which are unavailable
to the petitioner and the reasons for their
unavailability.
(d) Additional Information.--A petition may also include
other available relevant medical records relating to the person
who suffered such injury or who died from the administration of
the vaccine.
(e) Schedule.--The petitioner shall submit in accordance
with a schedule set by the special master assigned to the
petition assessments, evaluations, and prognoses and such other
records and documents as are reasonably necessary for the
determination of the amount of compensation to be paid to, or
on behalf of, the person who suffered such injury or who died
from the administration of the vaccine.
jurisdiction
Sec. 2112. [300aa-12] (a) General Rule.--The United States
Claims Court and the United States Claims Court special masters
shall, in accordance with this section, have jurisdiction over
proceedings to determine if a petitioner under section 2111 is
entitled to compensation under the Program and the amount of
such compensation. The United States Claims Court may issue and
enforce such orders as the court deems necessary to assure the
prompt payment of any compensation awarded.
(b) Parties.--
(1) In all proceedings brought by the filing of a
petition under section 2111(b), the Secretary shall be
named as the respondent, shall participate, and shall
be represented in accordance with section 518(a) of
title 28, United States Code.
(2) Within 30 days after the Secretary receives
service of any petition filed under section 2111 the
Secretary shall publish notice of such petition in the
Federal Register. The special master designated with
respect to such petition under subsection (c) shall
afford all interested persons an opportunity to submit
relevant, written information--
(A) relating to the existence of the
evidence described in section 2113(a)(1)(B), or
(B) relating to any allegation in a
petition with respect to the matters described
in section 2111(c)(1)(C)(ii).
(c) United States Claims Court Special Masters.--
(1) There is established within the United States
Claims Court an office of special masters which shall
consist of not more than 8 special masters. The judges
of the United States Claims Court shall appoint the
special masters, 1 of whom, by designation of the
judges of the United States Claims Court, shall serve
as chief special master. The appointment and
reappointment of the special masters shall be by the
concurrence of a majority of the judges of the court.
(2) The chief special master and other special
masters shall be subject to removal by the judges of
the United States Claims Court for incompetency,
misconduct, or neglect of duty or for physical or
mental disability or for other good cause shown.
(3) A special master's office shall be terminated
if the judges of the United States Claims Court
determine, upon advice of the chief special master,
that the services performed by that office are no
longer needed.
(4) The appointment of any individual as a special
master shall be for a term of 4 years, subject to
termination under paragraphs (2) and (3). Individuals
serving as special masters upon the date of the
enactment of this subsection shall serve for 4 years
from the date of their original appointment, subject to
termination under paragraphs (2) and (3). The chief
special master in office on the date of the enactment
of this subsection shall continue to serve as chief
special master for the balance of the master's term,
subject to termination under paragraphs (2) and (3).
(5) The compensation of the special masters shall
be determined by the judges of the United States Claims
Court, upon advice of the chief special master. The
salary of the chief special master shall be the annual
rate of basic pay for level IV of the Executive
Schedule, as prescribed by section 5315, title 5,
United States Code. The salaries of the other special
masters shall not exceed the annual rate of basic pay
of level V of the Executive Schedule, as prescribed by
section 5316, title 5, United States Code.
(6) The chief special master shall be responsible
for the following:
(A) Administering the office of special
masters and their staff, providing for the
efficient, expeditious, and effective handling
of petitions, and performing such other duties
related to the Program as may be assigned to
the chief special master by a concurrence of a
majority of the United States Claims Courts \1\
judges.
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``United States Court of Federal
Claims''.
---------------------------------------------------------------------------
(B) Appointing and fixing the salary and
duties of such administrative staff as are
necessary. Such staff shall be subject to
removal for good cause by the chief special
master.
(C) Managing and executing all aspects of
budgetary and administrative affairs affecting
the special masters and their staff, subject to
the rules and regulations of the Judicial
Conference of the United States. The Conference
rules and regulations pertaining to United
States magistrates shall be applied to the
special masters.
(D) Coordinating with the United States
Claims Court the use of services, equipment,
personnel, information, and facilities of the
United States Claims Court without
reimbursement.
(E) Reporting annually to the Congress and
the judges of the United States Claims Court on
the number of petitions filed under section
2111 and their disposition, the dates on which
the vaccine-related injuries and deaths for
which the petitions were filed occurred, the
types and amounts of awards, the length of time
for the disposition of petitions, the cost of
administering the Program, and recommendations
for changes in the Program.
(d) Special Masters.--
(1) Following the receipt and filing of a petition
under section 2111, the clerk of the United States
Claims Court shall forward the petition to the chief
special master who shall designate a special master to
carry out the functions authorized by paragraph (3).
(2) The special masters shall recommend rules to
the Claims Court and, taking into account such
recommended rules, the Claims Court shall promulgate
rules pursuant to section 2071 of title 28, United
States Code. Such rules shall--
(A) provide for a less-adversarial,
expeditious, and informal proceeding for the
resolution of petitions,
(B) include flexible and informal standards
of admissibility of evidence,
(C) include the opportunity for summary
judgment,
(D) include the opportunity for parties to
submit arguments and evidence on the record
without requiring routine use of oral
presentations, cross examinations, or hearings,
and
(E) provide for limitations on discovery
and allow the special masters to replace the
usual rules of discovery in civil actions in
the United States Claims Court.
(3)(A) A special master to whom a petition has been
assigned shall issue a decision on such petition with
respect to whether compensation is to be provided under
the Program and the amount of such compensation. The
decision of the special master shall--
(i) include findings of fact and
conclusions of law, and
(ii) be issued as expeditiously as
practicable but not later than 240 days,
exclusive of suspended time under subparagraph
(C), after the date the petition was filed.
The decision of the special master may be reviewed by
the United States Claims Court in accordance with
subsection (e).
(B) In conducting a proceeding on a petition a
special master--
(i) may require such evidence as may be
reasonable and necessary,
(ii) may require the submission of such
information as may be reasonable and necessary,
(iii) may require the testimony of any
person and the production of any documents as
may be reasonable and necessary,
(iv) shall afford all interested persons an
opportunity to submit relevant written
information--
(I) relating to the existence of
the evidence described in section
2113(a)(1)(B), or
(II) relating to any allegation in
a petition with respect to the matters
described in section 2111(c)(1)(C)(ii),
and
(v) may conduct such hearings as may be
reasonable and necessary.
There may be no discovery in a proceeding on a petition
other than the discovery required by the special
master.
(C) In conducting a proceeding on a petition a
special master shall suspend the proceedings one time
for 30 days on the motion of either party. After a
motion for suspension is granted, further motions for
suspension by either party may be granted by the
special master, if the special master determines the
suspension is reasonable and necessary, for an
aggregate period not to exceed 150 days.
(D) If, in reviewing proceedings on petitions for
vaccine-related injuries or deaths associated with the
administration of vaccines before the effective date of
this part, the chief special master determines that the
number of filings and resultant workload place an undue
burden on the parties or the special master involved in
such proceedings, the chief special master may, in the
interest of justice, suspend proceedings on any
petition for up to 30 months (but for not more than 6
months at a time) in addition to the suspension time
under subparagraph (C).
(4)(A) Except as provided in subparagraph (B),
information submitted to a special master or the court
in a proceeding on a petition may not be disclosed to a
person who is not a party to the proceeding without the
express written consent of the person who submitted the
information.
(B) A decision of a special master or the court in
a proceeding shall be disclosed, except that if the
decision is to include information--
(i) which is trade secret or commercial or
financial information which is privileged and
confidential, or
(ii) which are medical files and similar
files the disclosure of which would constitute
a clearly unwarranted invasion of privacy,
and if the person who submitted such information
objects to the inclusion of such information in the
decision, the decision shall be disclosed without such
information.
(e) Action by the United States Claims Court.--
(1) Upon issuance of the special master's decision,
the parties shall have 30 days to file with the clerk
of the United States Claims Court a motion to have the
court review the decision. If such a motion is filed,
the other party shall file a response with the clerk of
the United States Claims Court no later than 30 days
after the filing of such motion.
(2) Upon the filing of a motion under paragraph (1)
with respect to a petition, the United States Claims
Court shall have jurisdiction to undertake a review of
the record of the proceedings and may thereafter--
(A) uphold the findings of fact and
conclusions of law of the special master and
sustain the special master's decision,
(B) set aside any findings of fact or
conclusion of law of the special master found
to be arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with
law and issue its own findings of fact and
conclusions of law, or
(C) remand the petition to the special
master for further action in accordance with
the court's direction.
The court shall complete its action on a petition
within 120 days of the filing of a response under
paragraph (1) excluding any days the petition is before
a special master as a result of a remand under
subparagraph (C). The court may allow not more than 90
days for remands under subparagraph (C).
(3) In the absence of a motion under paragraph (1)
respecting the special master's decision or if the
United States Claims Court takes the action described
in paragraph (2)(A) with respect to the special
master's decision, the clerk of the United States
Claims Court shall immediately enter judgment in
accordance with the special master's decision.
(f) Appeals.--The findings of fact and conclusions of law
of the United States Claims Court on a petition shall be final
determinations of the matters involved, except that the
Secretary or any petitioner aggrieved by the findings or
conclusions of the court may obtain review of the judgment of
the court in the United States court of appeals for the Federal
Circuit upon petition filed within 60 days of the date of the
judgment with such court of appeals within 60 days of the date
of entry of the United States Claims Court's \1\ judgment with
such court of appeals.
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\1\ So in law. Probably should be a reference to the United States
Court of Federal Claims.
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(g) \2\ Notice.--If--
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\2\ Subsection (i)(2) of section 201 of Public Law 102-168 (105
Stat. 1104), which was enacted on November 26, 1991, provided that the
amendments made by subsections (d) and (f) of such section ``shall take
effect as if the amendments had been in effect on and after October 1,
1988''. Such subsections (d) and (f) related to actions by petitioners,
and to annuities, respectively, and involved amendments to sections
2112(g), 2115(f)(4), 2116(c), and 2121(b).
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(1) a special master fails to make a decision on a
petition within the 240 days prescribed by subsection
(d)(3)(A)(ii) (excluding (A) any period of suspension
under subsection (d)(3)(C) or (d)(3)(D), and (B) any
days the petition is before a special master as a
result of a remand under subsection (e)(2)(C)), or
(2) the United States Claims Court fails to enter a
judgment under this section on a petition within 420
days (excluding (A) any period of suspension under
subsection (d)(3)(C) or (d)(3)(D), and (B) any days the
petition is before a special master as a result of a
remand under subsection (e)(2)(C)) after the date on
which the petition was filed,
the special master or court shall notify the petitioner under
such petition that the petitioner may withdraw the petition
under section 2121(b) or the petitioner may choose under
section 2121(b) to have the petition remain before the special
master or court, as the case may be.
determination of eligibility and compensation
Sec. 2113. [300aa-13] (a) General Rule.--
(1) Compensation shall be awarded under the Program
to a petitioner if the special master or court finds on
the record as a whole--
(A) that the petitioner has demonstrated by
a preponderance of the evidence the matters
required in the petition by section 2111(c)(1),
and
(B) that there is not a preponderance of
the evidence that the illness, disability,
injury, condition, or death described in the
petition is due to factors unrelated to the
administration of the vaccine described in the
petition.
The special master or court may not make such a finding
based on the claims of a petitioner alone,
unsubstantiated by medical records or by medical
opinion.
(2) For purposes of paragraph (1), the term
``factors unrelated to the administration of the
vaccine''--
(A) does not include any idiopathic,
unexplained, unknown, hypothetical, or
undocumentable cause, factor, injury, illness,
or condition, and
(B) may, as documented by the petitioner's
evidence or other material in the record,
include infection, toxins, trauma (including
birth trauma and related anoxia), or metabolic
disturbances which have no known relation to
the vaccine involved, but which in the
particular case are shown to have been the
agent or agents principally responsible for
causing the petitioner's illness, disability,
injury, condition, or death.
(b) Matters To Be Considered.--
(1) In determining whether to award compensation to
a petitioner under the Program, the special master or
court shall consider, in addition to all other relevant
medical and scientific evidence contained in the
record--
(A) any diagnosis, conclusion, medical
judgment, or autopsy or coroner's report which
is contained in the record regarding the
nature, causation, and aggravation of the
petitioner's illness, disability, injury,
condition, or death, and
(B) the results of any diagnostic or
evaluative test which are contained in the
record and the summaries and conclusions.
Any such diagnosis, conclusion, judgment, test result,
report, or summary shall not be binding on the special
master or court. In evaluating the weight to be
afforded to any such diagnosis, conclusion, judgment,
test result, report, or summary, the special master or
court shall consider the entire record and the course
of the injury, disability, illness, or condition until
the date of the judgment of the special master or
court.
(2) The special master or court may find the first
symptom or manifestation of onset or significant
aggravation of an injury, disability, illness,
condition, or death described in a petition occurred
within the time period described in the Vaccine Injury
Table even though the occurrence of such symptom or
manifestation was not recorded or was incorrectly
recorded as having occurred outside such period. Such a
finding may be made only upon demonstration by a
preponderance of the evidence that the onset or
significant aggravation of the injury, disability,
illness, condition, or death described in the petition
did in fact occur within the time period described in
the Vaccine Injury Table.
(c) Record Defined.--For purposes of this section, the term
``record'' means the record established by the special masters
of the United States Claims Court in a proceeding on a petition
filed under section 2111.
vaccine injury table
Sec. 2114. [300aa-14] (a) Initial Table.--The following is
a table of vaccines, the injuries, disabilities, illnesses,
conditions, and deaths resulting from the administration of
such vaccines, and the time period in which the first symptom
or manifestation of onset or of the significant aggravation of
such injuries, disabilities, illnesses, conditions, and deaths
is to occur after vaccine administration for purposes of
receiving compensation under the Program:
VACCINE INJURY TABLE
I. DTP; P; DTP/Polio
Combination; or Any
Other Vaccine
Containing Whole Cell
Pertussis Bacteria,
Extracted or Partial
Cell Bacteria, or
Specific Pertussis
Antigen(s).
Illness, disability, Time period for first
injury, or condition symptom or
covered: manifestation of onset
or of significant
aggravation after
vaccine administration:
A. Anaphylaxis or 24 hours
anaphylactic shock.
B. Encephalopathy (or 3 days
encephalitis).
C. Shock-collapse or 3 days
hypotonic-
hyporesponsive collapse.
D. Residual seizure 3 days
disorder in accordance
with subsection (b)(2).
E. Any acute Not applicable
complication or sequela
(including death) of an
illness, disability,
injury, or condition
referred to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
II. Measles, mumps, rubella,
or any vaccine
containing any of the
foregoing as a
component; DT; Td; or
Tetanus Toxoid.
A. Anaphylaxis or 24 hours
anaphylactic shock.
B. Encephalopathy (or 15 days (for mumps,
encephalitis). rubella, measles, or
any vaccine containing
any of the foregoing as
a component). 3 days
(for DT, Td, or tetanus
toxoid).
C. Residual seizure 15 days (for mumps,
disorder in accordance rubella, measles, or
with subsection (b)(2). any vaccine containing
any of the foregoing as
a component). 3 days
(for DT, Td, or tetanus
toxoid).
D. Any acute Not applicable
complication or sequela
(including death) of an
illness, disability,
injury, or condition
referred to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
III. Polio Vaccines (other
than Inactivated Polio
Vaccine).
A. Paralytic polio
--in a non- 30 days
immunodeficient
recipient.
--in an 6 months
immunodeficient
recipient.
--in a vaccine- Not applicable
associated community
case.
B. Any acute Not applicable
complication or sequela
(including death) of an
illness, disability,
injury, or condition
referred to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
IV. Inactivated Polio
Vaccine.
A. Anaphylaxis or 24 hours
anaphylactic shock.
B. Any acute Not applicable
complication or sequela
(including death) of an
illness, disability,
injury, or condition
referred to above which
illness, disability,
injury, or condition
arose within the time
period prescribed.
(b) Qualifications and Aids to Interpretation.--The
following qualifications and aids to interpretation shall apply
to the Vaccine Injury Table in subsection (a):
(1) A shock-collapse or a hypotonic-hyporesponsive
collapse may be evidenced by indicia or symptoms such
as decrease or loss of muscle tone, paralysis (partial
or complete), hemiplegia or hemiparesis, loss of color
or turning pale white or blue, unresponsiveness to
environmental stimuli, depression of consciousness,
loss of consciousness, prolonged sleeping with
difficulty arousing, or cardiovascular or respiratory
arrest.
(2) A petitioner may be considered to have suffered
a residual seizure disorder if the petitioner did not
suffer a seizure or convulsion unaccompanied by fever
or accompanied by a fever of less than 102 degrees
Fahrenheit before the first seizure or convulsion after
the administration of the vaccine involved and if--
(A) in the case of a measles, mumps, or
rubella vaccine or any combination of such
vaccines, the first seizure or convulsion
occurred within 15 days after administration of
the vaccine and 2 or more seizures or
convulsions occurred within 1 year after the
administration of the vaccine which were
unaccompanied by fever or accompanied by a
fever of less than 102 degrees Fahrenheit, and
(B) in the case of any other vaccine, the
first seizure or convulsion occurred within 3
days after administration of the vaccine and 2
or more seizures or convulsions occurred within
1 year after the administration of the vaccine
which were unaccompanied by fever or
accompanied by a fever of less than 102 degrees
Fahrenheit.
(3)(A) The term ``encephalopathy'' means any
significant acquired abnormality of, or injury to, or
impairment of function of the brain. Among the frequent
manifestations of encephalopathy are focal and diffuse
neurologic signs, increased intracranial pressure, or
changes lasting at least 6 hours in level of
consciousness, with or without convulsions. The
neurological signs and symptoms of encephalopathy may
be temporary with complete recovery, or may result in
various degrees of permanent impairment. Signs and
symptoms such as high pitched and unusual screaming,
persistent unconsolable crying, and bulging fontanel
are compatible with an encephalopathy, but in and of
themselves are not conclusive evidence of
encephalopathy. Encephalopathy usually can be
documented by slow wave activity on an
electroencephalogram.
(B) If in a proceeding on a petition it is shown by
a preponderance of the evidence that an encephalopathy
was caused by infection, toxins, trauma, or metabolic
disturbances the encephalopathy shall not be considered
to be a condition set forth in the table. If at the
time a judgment is entered on a petition filed under
section 2111 for a vaccine-related injury or death it
is not possible to determine the cause, by a
preponderance of the evidence, of an encephalopathy,
the encephalopathy shall be considered to be a
condition set forth in the table. In determining
whether or not an encephalopathy is a condition set
forth in the table, the court shall consider the entire
medical record.
(4) For purposes of paragraphs (2) and (3), the
terms ``seizure'' and ``convulsion'' include grand mal,
petit mal, absence, myoclonic, tonic-clonic, and focal
motor seizures and signs. If a provision of the table
to which paragraph (1), (2), (3), or (4) applies is
revised under subsection (c) or (d), such paragraph
shall not apply to such provision after the effective
date of the revision unless the revision specifies that
such paragraph is to continue to apply.
(c) Administrative Revision of the Table.--
(1) The Secretary may promulgate regulations to
modify in accordance with paragraph (3) the Vaccine
Injury Table. In promulgating such regulations, the
Secretary shall provide for notice and opportunity for
a public hearing and at least 180 days of public
comment.
(2) Any person (including the Advisory Commission
on Childhood Vaccines) may petition the Secretary to
propose regulations to amend the Vaccine Injury Table.
Unless clearly frivolous, or initiated by the
Commission, any such petition shall be referred to the
Commission for its recommendations. Following--
(A) receipt of any recommendation of the
Commission, or
(B) 180 days after the date of the referral
to the Commission,
whichever occurs first, the Secretary shall conduct a
rulemaking proceeding on the matters proposed in the
petition or publish in the Federal Register a statement
of reasons for not conducting such proceeding.
(3) A modification of the Vaccine Injury Table
under paragraph (1) may add to, or delete from, the
list of injuries, disabilities, illnesses, conditions,
and deaths for which compensation may be provided or
may change the time periods for the first symptom or
manifestation of the onset or the significant
aggravation of any such injury, disability, illness,
condition, or death.
(4) Any modification under paragraph (1) of the
Vaccine Injury Table shall apply only with respect to
petitions for compensation under the Program which are
filed after the effective date of such regulation.
(d) Role of Commission.--Except with respect to a
regulation recommended by the Advisory Commission on Childhood
Vaccines, the Secretary may not propose a regulation under
subsection (c) or any revision thereof, unless the Secretary
has first provided to the Commission a copy of the proposed
regulation or revision, requested recommendations and comments
by the Commission, and afforded the Commission at least 90 days
to make such recommendations.
(e) \1\ Additional Vaccines.--
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\1\ Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646)
provides as follows:
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``(3) Effective date.--A revision by the Secretary under
section 2114(e) of the Public Health Service Act (42 U.S.C.
300aa-14(e)) (as amended by paragraph (2)) shall take effect
upon the effective date of a tax enacted to provide funds for
compensation paid with respect to the vaccine to be added to
the vaccine injury table in section 2114(a) of the Public
Health Service Act (42 U.S.C. 300aa-14(a)).''.
(1) Vaccines recommended before august 1, 1993.--By
August 1, 1995, the Secretary shall revise the Vaccine
Injury Table included in subsection (a) to include--
(A) vaccines which are recommended to the
Secretary by the Centers for Disease Control
and Prevention before August 1, 1993, for
routine administration to children,
(B) the injuries, disabilities, illnesses,
conditions, and deaths associated with such
vaccines, and
(C) the time period in which the first
symptoms or manifestations of onset or other
significant aggravation of such injuries,
disabilities, illnesses, conditions, and deaths
associated with such vaccines may occur.
(2) Vaccines recommended after august 1, 1993.--
When after August 1, 1993, the Centers for Disease
Control and Prevention recommends a vaccine to the
Secretary for routine administration to children, the
Secretary shall, within 2 years of such recommendation,
amend the Vaccine Injury Table included in subsection
(a) to include--
(A) vaccines which were recommended for
routine administration to children,
(B) the injuries, disabilities, illnesses,
conditions, and deaths associated with such
vaccines, and
(C) the time period in which the first
symptoms or manifestations of onset or other
significant aggravation of such injuries,
disabilities, illnesses, conditions, and deaths
associated with such vaccines may occur.
compensation
Sec. 2115. [300aa-15] (a) General Rule.--Compensation
awarded under the Program to a petitioner under section 2111
for a vaccine-related injury or death associated with the
administration of a vaccine after the effective date of this
part \1\ shall include the following:
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\1\ Effective October 1, 1988.
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(1)(A) Actual unreimbursable expenses incurred from
the date of the judgment awarding such expenses and
reasonable projected unreimbursable expenses which--
(i) result from the vaccine-related injury
for which the petitioner seeks compensation,
(ii) have been or will be incurred by or on
behalf of the person who suffered such injury,
and
(iii)(I) have been or will be for diagnosis
and medical or other remedial care determined
to be reasonably necessary, or
(II) have been or will be for
rehabilitation, developmental evaluation,
special education, vocational training and
placement, case management services,
counseling, emotional or behavioral therapy,
residential and custodial care and service
expenses, special equipment, related travel
expenses, and facilities determined to be
reasonably necessary.
(B) Subject to section 2116(a)(2), actual
unreimbursable expenses incurred before the date of the
judgment awarding such expenses which--
(i) resulted from the vaccine-related
injury for which the petitioner seeks
compensation,
(ii) were incurred by or on behalf of the
person who suffered such injury, and
(iii) were for diagnosis, medical or other
remedial care, rehabilitation, developmental
evaluation, special education, vocational
training and placement, case management
services, counseling, emotional or behavioral
therapy, residential and custodial care and
service expenses, special equipment, related
travel expenses, and facilities determined to
be reasonably necessary.
(2) In the event of a vaccine-related death, an
award of $250,000 for the estate of the deceased.
(3)(A) In the case of any person who has sustained
a vaccine-related injury after attaining the age of 18
and whose earning capacity is or has been impaired by
reason of such person's vaccine-related injury for
which compensation is to be awarded, compensation for
actual and anticipated loss of earnings determined in
accordance with generally recognized actuarial
principles and projections.
(B) In the case of any person who has sustained a
vaccine-related injury before attaining the age of 18
and whose earning capacity is or has been impaired by
reason of such person's vaccine-related injury for
which compensation is to be awarded and whose vaccine-
related injury is of sufficient severity to permit
reasonable anticipation that such person is likely to
suffer impaired earning capacity at age 18 and beyond,
compensation after attaining the age of 18 for loss of
earnings determined on the basis of the average gross
weekly earnings of workers in the private, non-farm
sector, less appropriate taxes and the average cost of
a health insurance policy, as determined by the
Secretary.
(4) For actual and projected pain and suffering and
emotional distress from the vaccine-related injury, an
award not to exceed $250,000.
(b) Vaccines Administered Before the Effective Date.--
Compensation awarded under the Program to a petitioner under
section 2111 for a vaccine-related injury or death associated
with the administration of a vaccine before the effective date
of this part \1\ may include the compensation described in
paragraphs (1)(A) and (2) of subsection (a) and may also
include an amount, not to exceed a combined total of $30,000,
for--
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\1\ Effective October 1, 1988.
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(1) lost earnings (as provided in paragraph
(3) of subsection (a)),
(2) pain and suffering (as provided in
paragraph (4) of subsection (a)), and
(3) reasonable attorneys' fees and costs
(as provided in subsection (e) \2\.
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\2\ So in law. Probably should be a closing parenthesis after
``subsection (e)''.
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(c) Residential and Custodial Care and Service.--The amount
of any compensation for residential and custodial care and
service expenses under subsection (a)(1) shall be sufficient to
enable the compensated person to remain living at home.
(d) Types of Compensation Prohibited.--Compensation awarded
under the Program may not include the following:
(1) Punitive or exemplary damages.
(2) Except with respect to compensation payments
under paragraphs (2) and (3) of subsection (a),
compensation for other than the health, education, or
welfare of the person who suffered the vaccine-related
injury with respect to which the compensation is paid.
(e) Attorneys' Fees.--
(1) In awarding compensation on a petition filed
under section 2111 the special master or court shall
also award as part of such compensation an amount to
cover--
(A) reasonable attorneys' fees, and
(B) other costs,
incurred in any proceeding on such petition. If the
judgment of a special master or court on such a
petition does not award compensation, the special
master or court may award an amount of compensation to
cover petitioner's reasonable attorneys' fees and other
costs incurred in any proceeding on such petition if
the special master or court determines that the
petition was brought in good faith and there was a
reasonable basis for the claim for which the petition
was brought.
(2) If the petitioner, before the effective date of
this part, \1\ filed a civil action for damages for any
vaccine-related injury or death for which compensation
may be awarded under the Program, and petitioned under
section 2111(a)(5) to have such action dismissed and to
file a petition for compensation under the Program, in
awarding compensation on such petition the special
master or court may include an amount of compensation
limited to the costs and expenses incurred by the
petitioner and the attorney of the petitioner before
the effective date of this part \1\ in preparing,
filing, and prosecuting such civil action (including
the reasonable value of the attorney's time if the
civil action was filed under contingent fee
arrangements).
(3) No attorney may charge any fee for services in
connection with a petition filed under section 2111
which is in addition to any amount awarded as
compensation by the special master or court under
paragraph (1).
(f) Payment of Compensation.--
(1) Except as provided in paragraph (2), no
compensation may be paid until an election has been
made, or has been deemed to have been made, under
section 2121(a) to receive compensation.
(2) Compensation described in subsection
(a)(1)(A)(iii) shall be paid from the date of the
judgment of the United States Claims Court under
section 2112 awarding the compensation. Such
compensation may not be paid after an election under
section 2121(a) to file a civil action for damages for
the vaccine-related injury or death for which such
compensation was awarded.
(3) Payments of compensation under the Program and
the costs of carrying out the Program shall be exempt
from reduction under any order issued under part C of
the Balanced Budget and Emergency Deficit Control Act
of 1985.
(4)(A) \1\ Except as provided in subparagraph (B),
payment of compensation under the Program shall be
determined on the basis of the net present value of the
elements of the compensation and shall be paid from the
Vaccine Injury Compensation Trust Fund established
under section 9510 of the Internal Revenue Code of 1986
in a lump sum of which all or a portion may be used as
ordered by the special master to purchase an annuity or
otherwise be used, with the consent of the petitioner,
in a manner determined by the special master to be in
the best interests of the petitioner.
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\1\ See footnote for section 2112(g).
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(B) In the case of a payment of compensation under
the Program to a petitioner for a vaccine-related
injury or death associated with the administration of a
vaccine before the effective date of this part \2\ the
compensation shall be determined on the basis of the
net present value of the elements of compensation and
paid in 4 equal annual installments of which all or a
portion of the proceeds \1\ may be used as ordered by
the special master to purchase an annuity or otherwise
be used, with the consent of the petitioner, in a
manner determined by the special master to be in the
best interests of the petitioner. Any reasonable
attorneys' fees and costs shall be paid in a lump sum.
If the appropriations under subsection (j) are
insufficient to make a payment of an annual
installment, the limitation on civil actions prescribed
by section 2121(a) shall not apply to a civil action
for damages brought by the petitioner entitled to the
payment.
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\2\ Effective October 1, 1988.
\1\ Section 201(e)(1)(B) of Public Law 102-168 (105 Stat. 1103)
provided that this subparagraph is amended by striking out ``paid in 4
equal installments of which all or portion of the proceeds'' and
inserting in lieu thereof ``shall be paid from appropriations made
available under subsection (j) in a lump sum of which all or a
portion''. The amendment cannot be executed because the term to be
struck does not appear in the law. (Compare ``equal installments'' with
``equal annual installments'' and ``or portion'' with ``or a
portion''.)
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(C) In purchasing an annuity under subparagraph (A)
or (B), the Secretary may purchase a guarantee for the
annuity, may enter into agreements regarding the
purchase price for and rate of return of the annuity,
and may take such other actions as may be necessary to
safeguard the financial interests of the United States
regarding the annuity. Any payment received by the
Secretary pursuant to the preceding sentence shall be
paid to the Vaccine Injury Compensation Trust Fund
established under section 9510 of the Internal Revenue
Code of 1986, or to the appropriations account from
which the funds were derived to purchase the annuity,
whichever is appropriate.
(g) Program Not Primarily Liable.--Payment of compensation
under the Program shall not be made for any item or service to
the extent that payment has been made, or can reasonably be
expected to be made, with respect to such item or service (1)
under any State compensation program, under an insurance
policy, or under any Federal or State health benefits program
(other than under title XIX of the Social Security Act), or (2)
by an entity which provides health services on a prepaid basis.
(h) Liability of Health Insurance Carriers, Prepaid Health
Plans, and Benefit Providers.--No policy of health insurance
may make payment of benefits under the policy secondary to the
payment of compensation under the Program and--
(1) no State, and
(2) no entity which provides health services on a
prepaid basis or provides health benefits,
may make the provision of health services or health benefits
secondary to the payment of compensation under the Program,
except that this subsection shall not apply to the provision of
services or benefits under title XIX of the Social Security
Act.
(i) Source of Compensation.--
(1) Payment of compensation under the Program to a
petitioner for a vaccine-related injury or death
associated with the administration of a vaccine before
the effective date of this part \1\ shall be made by
the Secretary from appropriations under subsection (j).
(2) Payment of compensation under the Program to a
petitioner for a vaccine-related injury or death
associated with the administration of a vaccine on or
after the effective date of this part \1\ shall be made
from the Vaccine Injury Compensation Trust Fund
established under section 9510 of the Internal Revenue
Code of 1986.
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\1\ Effective October 1, 1988.
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(j) Authorization.--For the payment of compensation under
the Program to a petitioner for a vaccine-related injury or
death associated with the administration of a vaccine before
the effective date of this part \1\ there are authorized to be
appropriated to the Department of Health and Human Services
$80,000,000 for fiscal year 1989, $80,000,000 for fiscal year
1990, $80,000,000 for fiscal year 1991, $80,000,000 for fiscal
year 1992, $110,000,000 for fiscal year 1993, and $110,000,000
for each succeeding fiscal year in which a payment of
compensation is required under subsection (f)(4)(B). Amounts
appropriated under this subsection shall remain available until
expended.
limitations of actions
Sec. 2116. [300aa-16] (a) General Rule.--In the case of--
(1) a vaccine set forth in the Vaccine Injury Table
which is administered before the effective date of this
part, \1\ if a vaccine-related injury or death occurred
as a result of the administration of such vaccine, no
petition may be filed for compensation under the
Program for such injury or death after the expiration
of 28 months after the effective date of this part \1\
and no such petition may be filed if the first symptom
or manifestation of onset or of the significant
aggravation of such injury occurred more than 36 months
after the date of administration of the vaccine,
(2) a vaccine set forth in the Vaccine Injury Table
which is administered after the effective date of this
part, \1\ if a vaccine-related injury occurred as a
result of the administration of such vaccine, no
petition may be filed for compensation under the
Program for such injury after the expiration of 36
months after the date of the occurrence of the first
symptom or manifestation of onset or of the significant
aggravation of such injury, and
(3) a vaccine set forth in the Vaccine Injury Table
which is administered after the effective date of this
part, \1\ if a death occurred as a result of the
administration of such vaccine, no petition may be
filed for compensation under the Program for such death
after the expiration of 24 months from the date of the
death and no such petition may be filed more than 48
months after the date of the occurrence of the first
symptom or manifestation of onset or of the significant
aggravation of the injury from which the death
resulted.
(b) Effect of Revised Table.--If at any time the Vaccine
Injury Table is revised and the effect of such revision is to
permit an individual who was not, before such revision,
eligible to seek compensation under the Program, or to
significantly increase the likelihood of obtaining
compensation, such person may, notwithstanding section
2111(b)(2), file a petition for such compensation not later
than 2 years after the effective date of the revision, except
that no compensation may be provided under the Program with
respect to a vaccine-related injury or death covered under the
revision of the table if--
(1) the vaccine-related death occurred more than 8
years before the date of the revision of the table, or
(2) the vaccine-related injury occurred more than 8
years before the date of the revision of the table.
(c) \1\ State Limitations of Actions.--If a petition is
filed under section 2111 for a vaccine-related injury or death,
limitations of actions under State law shall be stayed with
respect to a civil action brought for such injury or death for
the period beginning on the date the petition is filed and
ending on the date (1) an election is made under section
2121(a) to file the civil action or (2) an election is made
under section 2121(b) to withdraw the petition.
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\1\ See footnote for section 2112(g).
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subrogration
Sec. 2117. [300aa-17] (a) General Rule.--Upon payment of
compensation to any petitioner under the Program, the trust
fund which has been established to provide such compensation
shall be subrograted \2\ to all rights of the petitioner with
respect to the vaccine-related injury or death for which
compensation was paid, except that the trust fund may not
recover under such rights an amount greater than the amount of
compensation paid to the petitioner.
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\2\ So in law. Probably should be ``subrogated''.
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(b) Disposition of Amounts Recovered.--Amounts recovered
under subsection (a) shall be collected on behalf of, and
deposited in, the Vaccine Injury Compensation Trust Fund
established under section 9510 of the Internal Revenue Code of
1986.
advisory commission on childhood vaccines
Sec. 2119. [300aa-19] (a) Establishment.--There is
established the Advisory Commission on Childhood Vaccines. The
Commission shall be composed of:
(1) Nine members appointed by the Secretary as
follows:
(A) Three members who are health
professionals, who are not employees of the
United States, and who have expertise in the
health care of children, the epidemiology,
etiology, and prevention of childhood diseases,
and the adverse reactions associated with
vaccines, of whom at least two shall be
pediatricians.
(B) Three members from the general public,
of whom at least two shall be legal
representatives of children who have suffered a
vaccine-related injury or death.
(C) Three members who are attorneys, of
whom at least one shall be an attorney whose
specialty includes representation of persons
who have suffered a vaccine-related injury or
death and of whom one shall be an attorney
whose specialty includes representation of
vaccine manufacturers.
(2) The Director of the National Institutes of
Health, the Assistant Secretary for Health, the
Director of the Centers for Disease Control and
Prevention, and the Commissioner of Food and Drugs (or
the designees of such officials), each of whom shall be
a nonvoting ex officio member.
The Secretary shall select members of the Commission within 90
days of the effective date of this part. \1\ The members of the
Commission shall select a Chair from among the members.
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\1\ Effective October 1, 1988.
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(b) Term of Office.--Appointed members of the Commission
shall be appointed for a term of office of 3 years, except that
of the members first appointed, 3 shall be appointed for a term
of 1 year, 3 shall be appointed for a term of 2 years, and 3
shall be appointed for a term of 3 years, as determined by the
Secretary.
(c) Meetings.--The Commission shall first meet within 60
days after all members of the Commission are appointed, and
thereafter shall meet not less often than four times per year
and at the call of the chair. A quorum for purposes of a
meeting is 5. A decision at a meeting is to be made by a ballot
of a majority of the voting members of the Commission present
at the meeting.
(d) Compensation.--Members of the Commission who are
officers or employees of the Federal Government shall serve as
members of the Commission without compensation in addition to
that received in their regular public employment. Members of
the Commission who are not officers or employees of the Federal
Government shall be compensated at a rate not to exceed the
daily equivalent of the rate in effect for grade GS-18 of the
General Schedule for each day (including traveltime) they are
engaged in the performance of their duties as members of the
Commission. All members, while so serving away from their homes
or regular places of business, may be allowed travel expenses,
including per diem in lieu of subsistence, in the same manner
as such expenses are authorized by section 5703, title 5,
United States Code, for employees serving intermittently.
(e) Staff.--The Secretary shall provide the Commission with
such professional and clerical staff, such information, and the
services of such consultants as may be necessary to assist the
Commission in carrying out effectively its functions under this
section.
(f) Functions.--The Commission shall--
(1) advise the Secretary on the implementation of
the Program,
(2) on its own initiative or as the result of the
filing of a petition, recommend changes in the Vaccine
Injury Table,
(3) advise the Secretary in implementing the
Secretary's responsibilities under section 2127
regarding the need for childhood vaccination products
that result in fewer or no significant adverse
reactions,
(4) survey Federal, State, and local programs and
activities relating to the gathering of information on
injuries associated with the administration of
childhood vaccines, including the adverse reaction
reporting requirements of section 2125(b), and advise
the Secretary on means to obtain, compile, publish, and
use credible data related to the frequency and severity
of adverse reactions associated with childhood
vaccines, and
(5) recommend to the Director of the National
Vaccine Program research related to vaccine injuries
which should be conducted to carry out this subtitle.
Part B--Additional Remedies
authority to bring actions
Sec. 2121. [300aa-21] (a) Election.--After judgment has
been entered by the United States Claims Court or, if an appeal
is taken under section 2112(f), after the appellate court's
mandate is issued, the petitioner who filed the petition under
section 2111 shall file with the clerk of the United States
Claims Court--
(1) if the judgment awarded compensation, an
election in writing to receive the compensation or to
file a civil action for damages for such injury or
death, or
(2) if the judgment did not award compensation, an
election in writing to accept the judgment or to file a
civil action for damages for such injury or death.
An election shall be filed under this subsection not later than
90 days after the date of the court's final judgment with
respect to which the election is to be made. If a person
required to file an election with the court under this
subsection does not file the election within the time
prescribed for filing the election, such person shall be deemed
to have filed an election to accept the judgment of the court.
If a person elects to receive compensation under a judgment of
the court in an action for a vaccine-related injury or death
associated with the administration of a vaccine before the
effective date of this part or is deemed to have accepted the
judgment of the court in such an action, such person may not
bring or maintain a civil action for damages against a vaccine
administrator or manufacturer for the vaccine-related injury or
death for which the judgment was entered. For limitations on
the bringing of civil actions for vaccine-related injuries or
deaths associated with the administration of a vaccine after
the effective date of this part \1\, see section 2111(a)(2).
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\1\ Effective October 1, 1988.
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(b) \2\ Continuance or Withdrawal of Petition.\3\--A
petitioner under a petition filed under section 2111 may submit
to the United States Claims Court a notice in writing choosing
to continue or to withdraw the petition if--
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\2\ See footnote for section 2112(g).
\3\ The amendment described in section 201(d)(3)(C) of Public Law
102-168 (105 Stat. 1103) has been executed according to the probable
intent of the Congress. After redesignating former subparagraphs (A)
and (B) as paragraphs (1) and (2), the amendatory instructions of the
section provided that section 2121(b) is amended ``by running the text
of paragraph (1) into the subsection heading and making the margin of
the text full measure''. The instructions were applied to portions of
the matter preceding paragraph (1) as redesignated, rather than to the
text of paragraph (1). (That is, the instructions were applied to the
former paragraph (1).)
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(1) a special master fails to make a
decision on such petition within the 240 days
prescribed by section 2112(d)(3)(A)(ii)
(excluding (i) any period of suspension under
section 2112(d)(3)(C) or 2112(d)(3)(D), and
(ii) any days the petition is before a special
master as a result of a remand under section
2112(e)(2)(C)), or
(2) the court fails to enter a judgment
under section 2112 on the petition within 420
days (excluding (i) any period of suspension
under section 2112(d)(3)(C) or 2112(d)(3)(D),
and (ii) any days the petition is before a
special master as a result of a remand under
section 2112(e)(2)(C)) after the date on which
the petition was filed.
Such a notice shall be filed within 30 days of the
provision of the notice required by section 2112(g).
(c) Limitations of Actions.--A civil action for damages
arising from a vaccine-related injury or death for which a
petition was filed under section 2111 shall, except as provided
in section 2116(c), be brought within the period prescribed by
limitations of actions under State law applicable to such civil
action.
standards of responsibility
Sec. 2122. [300aa-22] (a) General Rule.--Except as provided
in subsections (b), (c), and (e) State law shall apply to a
civil action brought for damages for a vaccine-related injury
or death.
(b) Unavoidable Adverse Side Effects; Warnings.--
(1) No vaccine manufacturer shall be liable in a
civil action for damages arising from a vaccine-related
injury or death associated with the administration of a
vaccine after the effective date of this part \1\ if
the injury or death resulted from side effects that
were unavoidable even though the vaccine was properly
prepared and was accompanied by proper directions and
warnings.
(2) For purposes of paragraph (1), a vaccine shall
be presumed to be accompanied by proper directions and
warnings if the vaccine manufacturer shows that it
complied in all material respects with all requirements
under the Federal Food, Drug, and Cosmetic Act and
section 351 of the Public Health Service Act (including
regulations issued under such provisions) applicable to
the vaccine and related to vaccine-related injury or
death for which the civil action was brought unless the
plaintiff shows--
(A) that the manufacturer engaged in the
conduct set forth in subparagraph (A) or (B) of
section 2123(d)(2), or
(B) by clear and convincing evidence that
the manufacturer failed to exercise due care
notwithstanding its compliance with such Act
and section (and regulations issued under such
provisions).
(c) Direct Warnings.--No vaccine manufacturer shall be
liable in a civil action for damages arising from a vaccine-
related injury or death associated with the administration of a
vaccine after the effective date of this part \1\ solely due to
the manufacturer's failure to provide direct warnings to the
injured party (or the injured party's legal representative) of
the potential dangers resulting from the administration of the
vaccine manufactured by the manufacturer.
(d) Construction.--The standards of responsibility
prescribed by this section are not to be construed as
authorizing a person who brought a civil action for damages
against a vaccine manufacturer for a vaccine-related injury or
death in which damages were denied or which was dismissed with
prejudice to bring a new civil action against such manufacturer
for such injury or death.
(e) Preemption.--No State may establish or enforce a law
which prohibits an individual from bringing a civil action
against a vaccine manufacturer for damages for a vaccine-
related injury or death if such civil action is not barred by
this subtitle.
trial
Sec. 2123. [300aa-23] (a) General Rule.--A civil action
against a vaccine manufacturer for damages for a vaccine-
related injury or death associated with the administration of a
vaccine after the effective date of this part \1\ which is not
barred by section 2111(a)(2) shall be tried in three stages.
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\1\ Effective October 1, 1988.
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(b) Liability.--The first stage of such a civil action
shall be held to determine if a vaccine manufacturer is liable
under section 2122.
(c) General Damages.--The second stage of such a civil
action shall be held to determine the amount of damages (other
than punitive damages) a vaccine manufacturer found to be
liable under section 2122 shall be required to pay.
(d) Punitive Damages.--
(1) If sought by the plaintiff, the third stage of
such an action shall be held to determine the amount of
punitive damages a vaccine manufacturer found to be
liable under section 2122 shall be required to pay.
(2) If in such an action the manufacturer shows
that it complied, in all material respects, with all
requirements under the Federal Food, Drug, and Cosmetic
Act and the Public Health Service Act applicable to the
vaccine and related to the vaccine injury or death with
respect to which the action was brought, the
manufacturer shall not be held liable for punitive
damages unless the manufacturer engaged in--
(A) fraud or intentional and wrongful
withholding of information from the Secretary
during any phase of a proceeding for approval
of the vaccine under section 351,
(B) intentional and wrongful withholding of
information relating to the safety or efficacy
of the vaccine after its approval, or
(C) other criminal or illegal activity
relating to the safety and effectiveness of
vaccines,
which activity related to the vaccine-related injury or
death for which the civil action was brought.
(e) Evidence.--In any stage of a civil action, the Vaccine
Injury Table, any finding of fact or conclusion of law of the
United States Claims Court or a special master in a proceeding
on a petition filed under section 2111 and the final judgment
of the United States Claims Court and subsequent appellate
review on such a petition shall not be admissible.
Part C--Assuring a Safer Childhood Vaccination Program in the United
States
recording and reporting of information
Sec. 2125. [300aa-25] (a) General Rule.--Each health care
provider who administers a vaccine set forth in the Vaccine
Injury Table to any person shall record, or ensure that there
is recorded, in such person's permanent medical record (or in a
permanent office log or file to which a legal representative
shall have access upon request) with respect to each such
vaccine--
(1) the date of administration of the vaccine,
(2) the vaccine manufacturer and lot number of the
vaccine,
(3) the name and address and, if appropriate, the
title of the health care provider administering the
vaccine, and
(4) any other identifying information on the
vaccine required pursuant to regulations promulgated by
the Secretary.
(b) Reporting.--
(1) Each health care provider and vaccine
manufacturer shall report to the Secretary--
(A) the occurrence of any event set forth
in the Vaccine Injury Table, including the
events set forth in section 2114(b) which occur
within 7 days of the administration of any
vaccine set forth in the Table or within such
longer period as is specified in the Table or
section,
(B) the occurrence of any contraindicating
reaction to a vaccine which is specified in the
manufacturer's package insert, and
(C) such other matters as the Secretary may
by regulation require.
Reports of the matters referred to in subparagraphs (A)
and (B) shall be made beginning 90 days after the
effective date of this part. \1\ The Secretary shall
publish in the Federal Register as soon as practicable
after such date a notice of the reporting requirement.
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\1\ Effective December 22, 1987.
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(2) A report under paragraph (1) respecting a
vaccine shall include the time periods after the
administration of such vaccine within which vaccine-
related illnesses, disabilities, injuries, or
conditions, the symptoms and manifestations of such
illnesses, disabilities, injuries, or conditions, or
deaths occur, and the manufacturer and lot number of
the vaccine.
(3) The Secretary shall issue the regulations
referred to in paragraph (1)(C) within 180 days of the
effective date of this part. \1\
(c) Release of Information.--
(1) Information which is in the possession of the
Federal Government and State and local governments
under this section and which may identify an individual
shall not be made available under section 552 of title
5, United States Code, or otherwise, to any person
except--
(A) the person who received the vaccine, or
(B) the legal representative of such
person.
(2) For purposes of paragraph (1), the term
``information which may identify an individual'' shall
be limited to the name, street address, and telephone
number of the person who received the vaccine and of
that person's legal representative and the medical
records of such person relating to the administration
of the vaccine, and shall not include the locality and
State of vaccine administration, the name of the health
care provider who administered the vaccine, the date of
the vaccination, or information concerning any reported
illness, disability, injury, or condition resulting
from the administration of the vaccine, any symptom or
manifestation of such illness, disability, injury, or
condition, or death resulting from the administration
of the vaccine.
(3) Except as provided in paragraph (1), all
information reported under this section shall be
available to the public.
vaccine information
Sec. 2126. [300aa-26] (a) General Rule.--Not later than 1
year after the effective date of this part, \1\ the Secretary
shall develop and disseminate vaccine information materials for
distribution by health care providers to the legal
representatives of any child or to any other individual
receiving a vaccine set forth in the Vaccine Injury Table. Such
materials shall be published in the Federal Register and may be
revised.
(b) Development and Revision of Materials.--Such materials
shall be developed or revised--
(1) after notice to the public and 60 days of
comment thereon, and
(2) in consultation with the Advisory Commission on
Childhood Vaccines, appropriate health care providers
and parent organizations, the Centers for Disease
Control and Prevention, and the Food and Drug
Administration.
(c) Information Requirements.--The information in such
materials shall be based on available data and information,
shall be presented in understandable terms and shall include--
(1) a concise description of the benefits of the
vaccine,
(2) a concise description of the risks associated
with the vaccine,
(3) a statement of the availability of the National
Vaccine Injury Compensation Program, and
(4) such other relevant information as may be
determined by the Secretary.
(d) Health Care Provider Duties.--On and after a date
determined by the Secretary which is--
(1) after the Secretary develops the information
materials required by subsection (a), and
(2) not later than 6 months after the date such
materials are published in the Federal Register,
each health care provider who administers a vaccine set forth
in the Vaccine Injury Table shall provide to the legal
representatives of any child or to any other individual to whom
such provider intends to administer such vaccine a copy of the
information materials developed pursuant to subsection (a),
supplemented with visual presentations or oral explanations, in
appropriate cases. Such materials shall be provided prior to
the administration of such vaccine.
mandate for safer childhood vaccines
Sec. 2127. [300aa-27] (a) General Rule.--In the
administration of this subtitle and other pertinent laws under
the jurisdiction of the Secretary, the Secretary shall--
(1) promote the development of childhood vaccines
that result in fewer and less serious adverse reactions
than those vaccines on the market on the effective date
of this part \1\ and promote the refinement of such
vaccines, and
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\1\ Effective December 22, 1987.
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(2) make or assure improvements in, and otherwise
use the authorities of the Secretary with respect to,
the licensing, manufacturing, processing, testing,
labeling, warning, use instructions, distribution,
storage, administration, field surveillance, adverse
reaction reporting, and recall of reactogenic lots or
batches, of vaccines, and research on vaccines, in
order to reduce the risks of adverse reactions to
vaccines.
(b) Task Force.--
(1) The Secretary shall establish a task force on
safer childhood vaccines which shall consist of the
Director of the National Institutes of Health, the
Commissioner of the Food and Drug Administration, and
the Director of the Centers for Disease Control.
(2) The Director of the National Institutes of
Health shall serve as chairman of the task force.
(3) In consultation with the Advisory Commission on
Childhood Vaccines, the task force shall prepare
recommendations to the Secretary concerning
implementation of the requirements of subsection (a).
(c) Report.--Within 2 years after the effective date of
this part, \1\ and periodically thereafter, the Secretary shall
prepare and transmit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Labor and
Human Resources of the Senate a report describing the actions
taken pursuant to subsection (a) during the preceding 2-year
period.
manufacturer recordkeeping and reporting
Sec. 2128. [300aa-28] (a) General Rule.--Each vaccine
manufacturer of a vaccine set forth in the Vaccine Injury Table
or any other vaccine the administration of which is mandated by
the law or regulations of any State, shall, with respect to
each batch, lot, or other quantity manufactured or licensed
after the effective date of this part-- \1\
(1) prepare and maintain records documenting the
history of the manufacturing, processing, testing,
repooling, and reworking of each batch, lot, or other
quantity of such vaccine, including the identification
of any significant problems encountered in the
production, testing, or handling of such batch, lot, or
other quantity,
(2) if a safety test on such batch, lot, or other
quantity indicates a potential imminent or substantial
public health hazard is presented, report to the
Secretary within 24 hours of such safety test which the
manufacturer (or manufacturer's representative)
conducted, including the date of the test, the type of
vaccine tested, the identity of the batch, lot, or
other quantity tested, whether the batch, lot, or other
quantity tested is the product of repooling or
reworking of previous batches, lots, or other
quantities (and, if so, the identity of the previous
batches, lots, or other quantities which were repooled
or reworked), the complete test results, and the name
and address of the person responsible for conducting
the test,
(3) include with each such report a certification
signed by a responsible corporate official that such
report is true and complete, and
(4) prepare, maintain, and upon request submit to
the Secretary product distribution records for each
such vaccine by batch, lot, or other quantity number.
(b) Sanction.--Any vaccine manufacturer who intentionally
destroys, alters, falsifies, or conceals any record or report
required under paragraph (1) or (2) of subsection (a) shall--
(1) be subject to a civil penalty of up to $100,000
per occurrence, or
(2) be fined $50,000 or imprisoned for not more
than 1 year, or both.
Such penalty shall apply to the person who intentionally
destroyed, altered, falsified, or concealed such record or
report, to the person who directed that such record or report
be destroyed, altered, falsified, or concealed, and to the
vaccine manufacturer for which such person is an agent,
employee, or representative. Each act of destruction,
alteration, falsification, or concealment shall be treated as a
separate occurrence.
Part D--General Provisions
citizen's actions
Sec. 2131. [300aa-31] (a) General Rule.--Except as provided
in subsection (b), any person may commence in a district court
of the United States a civil action on such person's own behalf
against the Secretary where there is alleged a failure of the
Secretary to perform any act or duty under this subtitle.
(b) Notice.--No action may be commenced under subsection
(a) before the date which is 60 days after the person bringing
the action has given written notice of intent to commence such
action to the Secretary.
(c) Costs of Litigation.--The court, in issuing any final
order in any action under this section, may award costs of
litigation (including reasonable attorney and expert witness
fees) to any plaintiff who substantially prevails on one or
more significant issues in the action.
judicial review
Sec. 2132. [300aa-32] A petition for review of a regulation
under this subtitle may be filed in a court of appeals of the
United States within 60 days from the date of the promulgation
of the regulation or after such date if such petition is based
solely on grounds arising after such 60th day.
definitions
Sec. 2133. \1\ [300aa-33] For purposes of this subtitle:
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\1\ Paragraphs (3) and (5) above appear so as to reflect the
probable intent of the Congress, and former paragraph (7) has been
struck to reflect such intent. Sections 1714, 1715, and 1716 of Public
Law 107-296 (116 Stat. 2320, 2321) made amendments to section 2133 with
respect to such paragraphs. Subsequently, section 102(a) of division L
of Public Law 108-7 (117 Stat. 528) was enacted, and that section
indicated the intent of the Congress to nullify those amendments. That
section repealed sections 1714, 1715, and 1716 rather than directly
amending paragraphs (3), (5), and (7). (That section also repealed
section 1717, which related to effective dates.)
Section 102(b) of Public Law 108-7 provided as follows: ``The
Public Health Service Act (42 U.S.C. 201 et seq.) shall be applied and
administered as if the sections repealed by subsection (a) had never
been enacted.''. Consistent with that provision, section 2133 is shown
above to reflect the assumption that repealing a provision of law that
makes a change in an Act has the effect of amending that Act so as to
undo the change.
Section 102(c) of such Public Law provides as follows: ``No
inference shall be drawn from the enactment of sections 1714 through
1717 of the Homeland Security Act of 2002 (Public Law 107-296), or from
this repeal, regarding the law prior to enactment of sections 1714
through 1717 of the Homeland Security Act of 2002 (Public Law 107-296).
Further, no inference shall be drawn that subsection (a) or (b) affects
any change in that prior law, or that Leroy v. Secretary of Health and
Human Services, Office of Special Master, No. 02-392V (October 11,
2002), was incorrectly decided.''.
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(1) The term ``health care provider'' means any
licensed health care professional, organization, or
institution, whether public or private (including
Federal, State, and local departments, agencies, and
instrumentalities) under whose authority a vaccine set
forth in the Vaccine Injury Table is administered.
(2) The term ``legal representative'' means a
parent or an individual who qualifies as a legal
guardian under State law.
(3) The term ``manufacturer'' means any
corporation, organization, or institution, whether
public or private (including Federal, State, and local
departments, agencies, and instrumentalities), which
manufactures, imports, processes, or distributes under
its label any vaccine set forth in the Vaccine Injury
Table, except that, for purposes of section 2128, such
term shall include the manufacturer of any other
vaccine covered by that section. The term
``manufacture'' means to manufacture, import, process,
or distribute a vaccine.
(4) The term ``significant aggravation'' means any
change for the worse in a preexisting condition which
results in markedly greater disability, pain, or
illness accompanied by substantial deterioration of
health.
(5) The term ``vaccine-related injury or death''
means an illness, injury, condition, or death
associated with one or more of the vaccines set forth
in the Vaccine Injury Table, except that the term does
not include an illness, injury, condition, or death
associated with an adulterant or contaminant
intentionally added to such a vaccine.
(6)(A) The term ``Advisory Commission on Childhood
Vaccines'' means the Commission established under
section 2119.
(B) The term ``Vaccine Injury Table'' means the
table set out in section 2114.
h3 deg.termination of program
Sec. 2134. [300aa-34] (a) Reviews.--The Secretary shall
review the number of awards of compensation made under the
program to petitioners under section 2111 for vaccine-related
injuries and deaths associated with the administration of
vaccines on or after the effective date of this part \1\ as
follows:
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\1\ Effective December 22, 1987.
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(1) The Secretary shall review the number of such
awards made in the 12-month period beginning on the
effective date of this part. \1\
(2) At the end of each 3-month period beginning
after the expiration of the 12-month period referred to
in paragraph (1) the Secretary shall review the number
of such awards made in the 3-month period.
(b) Report.--
(1) If in conducting a review under subsection (a)
the Secretary determines that at the end of the period
reviewed the total number of awards made by the end of
that period and accepted under section 2121(a) exceeds
the number of awards listed next to the period reviewed
in the table in paragraph (2)--
(A) the Secretary shall notify the Congress
of such determination, and
(B) beginning 180 days after the receipt by
Congress of a notification under paragraph (1),
no petition for a vaccine-related injury or
death associated with the administration of a
vaccine on or after the effective date of this
part \1\ may be filed under section 2111.
Section 2111(a) and part B shall not apply to civil
actions for damages for a vaccine-related injury or
death for which a petition may not be filed because of
subparagraph (B).
(2) The table referred to in paragraph (1) is as
follows:
Total number of awards
by the end of the period
Period reviewed: reviewed
12 months after the effective date of part....... 150
13th through the 15th month after such date...... 188
16th through the 18th month after such date...... 225
19th through the 21st month after such date...... 263
22nd through the 24th month after such date...... 300
25th through the 27th month after such date...... 338
28th through the 30th month after such date...... 375
31st through the 33rd month after such date...... 413
34th through the 36th month after such date...... 450
37th through the 39th month after such date...... 488
40th through the 42nd month after such date...... 525
43rd through the 45th month after such date...... 563
46th through the 48th month after such date...... 600.
TITLE XXII--REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN
STATE AND LOCAL EMPLOYEES
SEC. 2201. [300BB-1] STATE AND LOCAL GOVERNMENTAL GROUP HEALTH PLANS
MUST PROVIDE CONTINUATION COVERAGE TO CERTAIN
INDIVIDUALS.
(a) In General.--In accordance with regulations which the
Secretary shall prescribe, each group health plan that is
maintained by any State that receives funds under this Act, by
any political subdivision of such a State, or by any agency or
instrumentality of such a State or political subdivision, shall
provide, in accordance with this title, that each qualified
beneficiary who would lose coverage under the plan as a result
of a qualifying event is entitled, under the plan, to elect,
within the election period, continuation coverage under the
plan.
(b) Exception for Certain Plans.--Subsection (a) shall not
apply to--
(1) any group health plan for any calendar year if
all employers maintaining such plan normally employed
fewer than 20 employees on a typical business day
during the preceding calendar year, or
(2) any group health plan maintained for employees
by the government of the District of Columbia or any
territory or possession of the United States or any
agency or instrumentality.
SEC. 2202. [300BB-2] CONTINUATION COVERAGE.
For purposes of section 2201, the term ``continuation
coverage'' means coverage under the plan which meets the
following requirements:
(1) Type of benefit coverage.--The coverage must
consist of coverage which, as of the time the coverage
is being provided, is identical to the coverage
provided under the plan to similarly situated
beneficiaries under the plan with respect to whom a
qualifying event has not occurred. If coverage is
modified under the plan for any group of similarly
situated beneficiaries, such coverage shall also be
modified in the same manner for all individuals who are
qualified beneficiaries under the plan pursuant to this
part \1\ in connection with such group.
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\1\ So in law. This title is not divided into parts.
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(2) Period of coverage.--The coverage must extend
for at least the period beginning on the date of the
qualifying event and ending not earlier than the
earliest of the following:
(A) Maximum required period.--
(i) General rule for terminations
and reduced hours.--In the case of a
qualifying event described in section
2203(2), except as provided in clause
(ii), the date which is 18 months after
the date of the qualifying event.
(ii) Special rule for multiple
qualifying events.--If a qualifying
event occurs during the 18 months after
the date of a qualifying event
described in section 2203(2), the date
which is 36 months after the date of
the qualifying event described in
section 2203(2).
(iii) General rule for other
qualifying events.--In the case of a
qualifying event not described in
section 2203(2), the date which is 36
months after the date of the qualifying
event.
(iv) Special rule for taa-eligible
individuals.--In the case of a
qualifying event described in section
2203(2) with respect to a covered
employee who is (as of the date that
the period of coverage would, but for
this clause or clause (v), otherwise
terminate under clause (i) or (ii)) a
TAA-eligible individual (as defined in
section 2205(b)(4)(B)), the period of
coverage shall not terminate by reason
of clause (i) or (ii), as the case may
be, before the later of the date
specified in such clause or the date on
which such individual ceases to be such
a TAA-eligible individual. The
preceding sentence shall not require
any period of coverage to extend beyond
February 12, 2011.
(v) Medicare entitlement followed
by qualifying event.--In the case of a
qualifying event described in section
2203(2) that occurs less than 18 months
after the date the covered employee
became entitled to benefits under title
XVIII of the Social Security Act, the
period of coverage for qualified
beneficiaries other than the covered
employee shall not terminate under this
subparagraph before the close of the
36-month period beginning on the date
the covered employee became so
entitled.
(vi) Special rule for disability.--
In the case of a qualified beneficiary
who is determined, under title II or
XVI of the Social Security Act, to have
been disabled at any time during the
first 60 days of continuation coverage
under this title, any reference in
clause (i) or (ii) to 18 months with
respect to such event \1\ is deemed a
reference to 29 months (with respect to
all qualified beneficiaries), but only
if the qualified beneficiary has
provided notice of such determination
under section 2206(3) before the end of
such 18 months.
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\1\ Section 421(a)(1)(A)(ii)(III) of Public Law 104-191 (110 Stat.
2087) provides that the last sentence of subparagraph (A) is amended by
striking ``with respect to such event,''. The amendment cannot be
executed because the term to be struck does not appear. (Compare ``with
respect to such event,'' and ``with respect to such event''.)
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(B) End of plan.--The date on which the
employer ceases to provide any group health
plan to any employee.
(C) Failure to pay premium.--The date on
which coverage ceases under the plan by reason
of a failure to make timely payment of any
premium required under the plan with respect to
the qualified beneficiary. The payment of any
premium (other than any payment referred to in
the last sentence of paragraph (3)) shall be
considered to be timely if made within 30 days
after the date due or within such longer period
as applies to or under the plan.
(D) Group health plan coverage or medicare
entitlememt.--The date on which the qualified
beneficiary first becomes, after the date of
the election--
(i) covered under any other group
health plan (as an employee or
otherwise) which does not contain any
exclusion or limitation with respect to
any preexisting condition of such
beneficiary (other than such an
exclusion or limitation which does not
apply to (or is satisfied by) such
beneficiary by reason of chapter 100 of
the Internal Revenue Code of 1986, part
7 of subtitle B of title I of the
Employee Retirement Income Security Act
of 1974, or title XXVII of this Act),
or
(ii) entitled to benefits under
title XVIII of the Social Security Act.
(E) Termination of extended coverage for
disability.--In the case of a qualified
beneficiary who is disabled at any time during
the first 60 days of continuation coverage
under this title, the month that begins more
than 30 days after the date of the final
determination under title II or XVI of the
Social Security Act that the qualified
beneficiary is no longer disabled.
(3) Premium requirements.--The plan may require
payment of a premium for any period of continuation
coverage, except that such premium--
(A) shall not exceed 102 percent of the
applicable premium for such period, and
(B) may, at the election of the payor, be
made in monthly installments.
In no event may the plan require the payment of any
premium before the day which is 45 days after the day
on which the qualified beneficiary made the initial
election for continuation coverage. In the case of an
individual described in the last sentence of paragraph
(2)(A), any reference in subparagraph (A) of this
paragraph to ``102 percent'' is deemed a reference to
``150 percent'' for any month after the 18th month of
continuation coverage described in clause (i) or (ii)
of paragraph (2)(A).
(4) No requirement of insurability.--The coverage
may not be conditioned upon, or discriminate on the
basis of lack of, evidence of insurability.
(5) Conversion option.--In the case of a qualified
beneficiary whose period of continuation coverage
expires under paragraph (2)(A), the plan must, during
the 180-day period ending on such expiration date,
provide to the qualified beneficiary the option of
enrollment under a conversion health plan otherwise
generally available under the plan.
SEC. 2203. [300BB-3] QUALIFYING EVENT.
For purposes of this title, the term ``qualifying event''
means, with respect to any covered employee, any of the
following events which, but for the continuation coverage
required under this title, would result in the loss of coverage
of a qualified beneficiary:
(1) The death of the covered employee.
(2) The termination (other than by reason of such
employee's gross misconduct), or reduction of hours, of
the covered employee's employment.
(3) The divorce or legal separation of the covered
employee from the employee's spouse.
(4) The covered employee becoming entitled to
benefits under title XVIII of the Social Security Act.
(5) A dependent child ceasing to be a dependent
child under the generally applicable requirements of
the plan.
SEC. 2204. [300BB-4] APPLICABLE PREMIUM.
For purposes of this title--
(1) In general.--The term ``applicable premium''
means, with respect to any period of continuation
coverage of qualified beneficiaries, the cost to the
plan for such period of the coverage for similarly
situated beneficiaries with respect to whom a
qualifying event has not occurred (without regard to
whether such cost is paid by the employer or employee).
(2) Special rule for self-insured plans.--To the
extent that a plan is a self-insured plan--
(A) In general.--Except as provided in
subparagraph (B), the applicable premium for
any period of continuation coverage of
qualified beneficiaries shall be equal to a
reasonable estimate of the cost of providing
coverage for such period for similarly situated
beneficiaries which--
(i) is determined on an actuarial
basis, and
(ii) takes into account such
factors as the Secretary may prescribe
in regulations.
(B) Determination on basis of past cost.--
If a plan administrator elects to have this
subparagraph apply, the applicable premium for
any period of continuation coverage of
qualified beneficiaries shall be equal to--
(i) the cost to the plan for
similarly situated beneficiaries for
the same period occurring during the
preceding determination period under
paragraph (3), adjusted by
(ii) the percentage increase or
decrease in the implicit price deflator
of the gross national product
(calculated by the Department of
Commerce and published in the Survey of
Current Business) for the 12-month
period ending on the last day of the
sixth month of such preceding
determination period.
(C) Subparagraph (b) not to apply where
significant change.--A plan administrator may
not elect to have subparagraph (B) apply in any
case in which there is any significant
difference, between the determination period
and the preceding determination period, in
coverage under, or in employees covered by, the
plan. The determination under the preceding
sentence for any determination period shall be
made at the same time as the determination
under paragraph (3).
(3) Determination period.--The determination of any
applicable premium shall be made for a period of 12
months and shall be made before the beginning of such
period.
SEC. 2205. [300BB-5] ELECTION.
(a) In General.--For purposes of this title--
(1) Election period.--The term ``election period''
means the period which--
(A) begins not later than the date on which
coverage terminates under the plan by reason of
a qualifying event,
(B) is of at least 60 days' duration, and
(C) ends not earlier than 60 days after the
later of--
(i) the date described in
subparagraph (A), or
(ii) in the case of any qualified
beneficiary who receives notice under
section 2206(4), the date of such
notice.
(2) Effect of election on other beneficiaries.--
Except as otherwise specified in an election, any
election of continuation coverage by a qualified
beneficiary described in subparagraph (A)(i) or (B) of
section 2208(3) shall be deemed to include an election
of continuation coverage on behalf of any other
qualified beneficiary who would lose coverage under the
plan by reason of the qualifying event. If there is a
choice among types of coverage under the plan, each
qualified beneficiary is entitled to make a separate
selection among such types of coverage.
(b) Temporary Extension of COBRA Election Period for
Certain Individuals.--
(1) In general.--In the case of a nonelecting TAA-
eligible individual and notwithstanding subsection (a),
such individual may elect continuation coverage under
this title during the 60-day period that begins on the
first day of the month in which the individual becomes
a TAA-eligible individual, but only if such election is
made not later than 6 months after the date of the TAA-
related loss of coverage.
(2) Commencement of coverage; no reach-back.--Any
continuation coverage elected by a TAA-eligible
individual under paragraph (1) shall commence at the
beginning of the 60-day election period described in
such paragraph and shall not include any period prior
to such 60-day election period.
(3) Preexisting conditions.--With respect to an
individual who elects continuation coverage pursuant to
paragraph (1), the period--
(A) beginning on the date of the TAA-
related loss of coverage, and
(B) ending on the first day of the 60-day
election period described in paragraph (1),
shall be disregarded for purposes of determining the
63-day periods referred to in section 2701(c)(2),
section 701(c)(2) of the Employee Retirement Income
Security Act of 1974, and section 9801(c)(2) of the
Internal Revenue Code of 1986.
(4) Definitions.--For purposes of this subsection:
(A) Nonelecting taa-eligible individual.--
The term ``nonelecting TAA-eligible
individual'' means a TAA-eligible individual
who--
(i) has a TAA-related loss of
coverage; and
(ii) did not elect continuation
coverage under this part during the
TAA-related election period.
(B) TAA-eligible individual.--The term
``TAA-eligible individual'' means--
(i) an eligible TAA recipient (as
defined in paragraph (2) of section
35(c) of the Internal Revenue Code of
1986), and
(ii) an eligible alternative TAA
recipient (as defined in paragraph (3)
of such section).
(C) TAA-related election period.--The term
``TAA-related election period'' means, with
respect to a TAA-related loss of coverage, the
60-day election period under this part which is
a direct consequence of such loss.
(D) TAA-related loss of coverage.--The term
``TAA-related loss of coverage'' means, with
respect to an individual whose separation from
employment gives rise to being an TAA-eligible
individual, the loss of health benefits
coverage associated with such separation.
SEC. 2206. [300BB-6] NOTICE REQUIREMENTS.
In accordance with regulations prescribed by the
Secretary--
(1) the group health plan shall provide, at the
time of commencement of coverage under the plan,
written notice to each covered employee and spouse of
the employee (if any) of the rights provided under this
subsection, \1\
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\1\ So in law. Probably should be ``this title''.
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(2) the employer of an employee under a plan must
notify the plan administrator of a qualifying event
described in paragraph (1), (2), or (4) of section 2203
within 30 days of the date of the qualifying event,
(3) each covered employee or qualified beneficiary
is responsible for notifying the plan administrator of
the occurrence of any qualifying event described in
paragraph (3) or (5) of section 2203 within 60 days
after the date of the qualifying event and each
qualified beneficiary who is determined, under title II
or XVI of the Social Security Act, to have been
disabled at any time during the first 60 days of
continuation coverage under this title is responsible
for notifying the plan administrator of such
determination within 60 days after the date of the
determination and for notifying the plan administrator
within 30 days after the date of any final
determination under such title or titles that the
qualified beneficiary is no longer disabled, and
(4) the plan administrator shall notify--
(A) in the case of a qualifying event
described in paragraph (1), (2), or (4) of
section 2203, any qualified beneficiary with
respect to such event, and
(B) in the case of a qualifying event
described in paragraph (3) or (5) of section
2203 where the covered employee notifies the
plan administrator under paragraph (3), any
qualified beneficiary with respect to such
event,
of such beneficiary's rights under this subsection. \1\
For purposes of paragraph (4), any notification shall be made
within 14 days of the date on which the plan administrator is
notified under paragraph (2) or (3), whichever is applicable,
and any such notification to an individual who is a qualified
beneficiary as the spouse of the covered employee shall be
treated as notification to all other qualified beneficiaries
residing with such spouse at the time such notification is
made.
SEC. 2207. \2\ [300bb-7] ENFORCEMENT.
Any individual who is aggrieved by the failure of a State,
political subdivision, or agency or instrumentality thereof, to
comply with the requirements of this title may bring an action
for appropriate equitable relief.
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\2\ Section 13631(d) of Public Law 103-66 (107 Stat. 643) provides
as follows:
(d) Continued Coverage of Costs of a Pediatric Vaccine Under
Certain Group Health Plans.--
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(1) Requirement.--The requirement of this paragraph, with
respect to a group health plan for plan years beginning after
the date of the enactment of this Act, is that the group health
plan not reduce its coverage of the costs of pediatric vaccines
(as defined under section 1928(h)(6) of the Social Security
Act) below the coverage it provided as of May 1, 1993.
(2) Enforcement.--For purposes of section 2207 of the Public
Health Service Act, the requirement of paragraph (1) is deemed
a requirement of title XXII of such Act.
SEC. 2208. [300BB-8] DEFINITIONS.
For purposes of this title--
(1) Group health plan.--The term ``group health
plan'' has the meaning given such term in 5000(b) \1\
of the Internal Revenue Code of 1986. Such term shall
not include any plan substantially all of the coverage
under which is for qualified long-term care services
(as defined in section 7702B(c) of such Code).
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\1\ So in law. The word ``section'' does not appear. See section
102(d) of Public Law 104-191 (110 Stat. 1978).
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(2) Covered employee.--The term ``covered
employee'' means an individual who is (or was) provided
coverage under a group health plan by virtue of the
performance of services by the individual for 1 or more
persons maintaining the plan (including as an employee
defined in section 401(c)(1) of the Internal Revenue
Code of 1986).
(3) Qualified beneficiary.--
(A) In general.--The term ``qualified
beneficiary'' means, with respect to a covered
employee under a group health plan, any other
individual who, on the day before the
qualifying event for that employee, is a
beneficiary under the plan--
(i) as the spouse of the covered
employee, or
(ii) as the dependent child of the
employee.
Such term shall also include a child who is born to or
placed for adoption with the covered employee during
the period of continuation coverage under this title.
\2\
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\2\ Indentation is so in law. See section 401(a)(3) of Public Law
104-191 (110 Stat. 2085).
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(B) Special rule for terminations and
reduced employment.--In the case of a
qualifying event described in section 2203(2),
the term ``qualified beneficiary'' includes the
covered employee.
(4) Plan administrator.--The term ``plan
administrator'' has the meaning given the term
``administrator'' by section 3(16)(A) of the Employee
Retirement Income Security Act of 1974.
H1 deg.TITLE XXIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE
DEFICIENCY SYNDROME \1\
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\1\ Subtitle E of title II of Public Law 100-607 (102 Stat. 3108)
established various authorities regarding acquired immune deficiency
syndrome.
Section 2301 was repealed by section 104(b)(2)(C) of Public Law
109-482.
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Part A--Administration of Research Programs
H4 deg.SEC. 2302. [300CC-1] REQUIREMENT OF EXPEDITING AWARDS
OF GRANTS AND CONTRACTS FOR RESEARCH.
(a) In General.--The Secretary shall expedite the award of
grants, contracts, and cooperative agreements for research
projects relating to acquired immune deficiency syndrome
(including such research projects initiated independently of
any solicitation by the Secretary for proposals for such
research projects).
(b) Time Limitations With Respect to Certain
Applications.--
(1) With respect to programs of grants, contracts,
and cooperative agreements described in subsection (a),
any application submitted in response to a solicitation
by the Secretary for proposals pursuant to such a
program--
(A) may not be approved if the application
is submitted after the expiration of the 3-
month period beginning on the date on which the
solicitation is issued; and
(B) shall be awarded, or otherwise finally
acted upon, not later than the expiration of
the 6-month period beginning on the expiration
of the period described in subparagraph (A).
(2) If the Secretary makes a determination that it
is not practicable to administer a program referred to
in paragraph (1) in accordance with the time
limitations described in such paragraph, the Secretary
may adjust the time limitations accordingly.
(c) Requirements With Respect to Adjustments in Time
Limitations.--With respect to any program for which a
determination described in subsection (b)(2) is made, the
Secretary shall--
(1) if the determination is made before the
Secretary issues a solicitation for proposals pursuant
to the program, ensure that the solicitation describes
the time limitations as adjusted by the determination;
and
(2) if the determination is made after the
Secretary issues such a solicitation for proposals,
issue a statement describing the time limitations as
adjusted by the determination and individually notify,
with respect to the determination, each applicant whose
application is submitted before the expiration of the
3-month period beginning on the date on which the
solicitation was issued.
(d) Annual Reports to Congress.--Except as provided in
subsection (e), the Secretary shall annually prepare, for
inclusion in the comprehensive report required in section 2301,
a report--
(A) \1\ summarizing programs for which the
Secretary has made a determination described in
subsection (b)(2), including a description of the time
limitations as adjusted by the determination and
including a summary of the solicitation issued by the
Secretary for proposals pursuant to the program; and
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\1\ Designations are so in law. Subparagraphs (A) and (B) should
probably be designated paragraphs (1) and (2), respectively. Similarly,
clauses (i) and (ii) of subparagraph (B) should probably be designated
subparagraphs (A) and (B), respectively.
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(B) summarizing applications that--
(i) were submitted pursuant to a program of
grants, contracts, or cooperative agreements
referred to in paragraph (1) of subsection (b)
for which a determination described in
paragraph (2) of such subsection has not been
made; and
(ii) were not processed in accordance with
the time limitations described in such
paragraph (1).
(e) Quarterly Reports for Fiscal Year 1989.--For fiscal
year 1989, the report required in subsection (d) shall, not
less than quarterly, be prepared and submitted to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate.
SEC. 2303. [300CC-2] REQUIREMENTS WITH RESPECT TO PROCESSING OF
REQUESTS FOR PERSONNEL AND ADMINISTRATIVE SUPPORT.
(a) In General.--The Director of the Office of Personnel
Management or the Administrator of General Services, as the
case may be, shall respond to any priority request made by the
Administrator of the Alcohol, Drug Abuse, and Mental Health
Administration, the Director of the Centers for Disease Control
and Prevention, the Commissioner of Food and Drugs, or the
Director of the National Institutes of Health, not later than
21 days after the date on which such request is made. If the
Director of the Office of Personnel Management or the
Administrator of General Services, as the case may be, does not
disapprove a priority request during the 21-day period, the
request shall be deemed to be approved.
(b) Notice to Secretary and to Assistant Secretary for
Health.--The Administrator of the Substance Abuse and Mental
Health Services Administration, the Director of the Centers for
Disease Control and Prevention, the Commissioner of Food and
Drugs, and the Director of the National Institutes of Health,
shall, respectively, transmit to the Secretary and the
Assistant Secretary for Health a copy of each priority request
made under this section by the agency head involved. The copy
shall be transmitted on the date on which the priority request
involved is made.
(c) Definition of Priority Request.--For purposes of this
section, the term ``priority request'' means any request that--
(1) is designated as a priority request by the
Administrator of the Substance Abuse and Mental Health
Services Administration, the Director of the Centers
for Disease Control and Prevention, the Commissioner of
Food and Drugs, or the Director of the National
Institutes of Health; and
(2)(A) is made to the Director of the Office of
Personnel Management for the allocation of personnel to
carry out activities with respect to acquired immune
deficiency syndrome; or
(B) is made to the Administrator of General
Services for administrative support or space in
carrying out such activities.
SEC. 2304. [300CC-3] ESTABLISHMENT OF RESEARCH ADVISORY COMMITTEE.
(a) In General.--After consultation with the Commissioner
of Food and Drugs, the Secretary, acting through the Director
of the National Institute of Allergy and Infectious Diseases,
shall establish within such Institute an advisory committee to
be known as the AIDS Research Advisory Committee (hereafter in
this section referred to as the ``Committee'').
(b) Composition.--The Committee shall be composed of
physicians whose clinical practice includes a significant
number of patients with acquired immune deficiency syndrome.
(c) Duties.--The Committee shall--
(1) advise the Director of such Institute (and may
provide advice to the Directors of other agencies of
the National Institutes of Health, as appropriate) on
appropriate research activities to be undertaken with
respect to clinical treatment of such syndrome,
including advice with respect to--
(A) research on drugs for preventing or
minimizing the development of symptoms or
conditions arising from infection with the
etiologic agent for such syndrome, including
recommendations on the projects of research
with respect to diagnosing immune deficiency
and with respect to predicting, diagnosing,
preventing, and treating opportunistic cancers
and infectious diseases; and
(B) research on the effectiveness of
treating such symptoms or conditions with drugs
that--
(i) are not approved by the
Commissioner of Food and Drugs for the
purpose of treating such symptoms or
conditions; and
(ii) are being utilized for such
purpose by individuals infected with
such etiologic agent;
(2)(A) review ongoing publicly and privately
supported research on clinical treatment for acquired
immune deficiency syndrome, including research on drugs
described in paragraph (1); and
(B) periodically issue, and make available to
health care professionals, reports describing and
evaluating such research;
(3) conduct studies and convene meetings for the
purpose of determining the recommendations among
physicians in clinical practice on clinical treatment
of acquired immune deficiency syndrome, including
treatment with the drugs described in paragraph (1);
and
(4) conduct a study for the purpose of developing,
with respect to individuals infected with the etiologic
agent for acquired immune deficiency syndrome, a
consensus among health care professionals on clinical
treatments for preventing or minimizing the development
of symptoms or conditions arising from infection with
such etiologic agent.
H2 deg.Part B--Research Authority
SEC. 2311. [300CC-11] CLINICAL EVALUATION UNITS AT NATIONAL INSTITUTES
OF HEALTH.
(a) In General.--The Secretary, acting through the Director
of the National Cancer Institute and the Director of the
National Institute of Allergy and Infectious Diseases, shall
for each such Institute establish a clinical evaluation unit at
the Clinical Center at the National Institutes of Health. Each
of the clinical evaluation units--
(1) shall conduct clinical evaluations of
experimental treatments for acquired immune deficiency
syndrome developed within the preclinical drug
development program, including evaluations of methods
of diagnosing immune deficiency and evaluations of
methods of predicting, diagnosing, preventing, and
treating opportunistic cancers and infectious diseases;
and
(2) may conduct clinical evaluations of
experimental treatments for such syndrome that are
developed by any other national research institute of
the National Institutes of Health or by any other
entity.
(b) Personnel and Administrative Support.--
(1) For the purposes described in subsection (a),
the Secretary, acting through the Director of the
National Institutes of Health, shall provide each of
the clinical evaluation units required in such
subsection--
(A)(i) with not less than 50 beds; or
(ii) with an outpatient clinical capacity
equal to not less than twice the outpatient
clinical capacity, with respect to acquired
immune deficiency syndrome, possessed by the
Clinical Center of the National Institutes of
Health on June 1, 1988; and
(B) with such personnel, such
administrative support, and such other support
services as may be necessary.
(2) Facilities, personnel, administrative support,
and other support services provided pursuant to
paragraph (1) shall be in addition to the number or
level of facilities, personnel, administrative support,
and other support services that otherwise would be
available at the Clinical Center at the National
Institutes of Health for the provision of clinical care
for individuals with diseases or disorders.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary.
H4 deg.SEC. 2312. [300CC-12] USE OF INVESTIGATIONAL NEW
DRUGS WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY
SYNDROME.
(a) Encouragement of Applications With Respect to Clinical
Trials.--
(1) If, in the determination of the Secretary,
there is preliminary evidence that a new drug has
effectiveness in humans with respect to the prevention
or treatment of acquired immune deficiency syndrome,
the Secretary shall, through statements published in
the Federal Register--
(A) announce the fact of such
determination; and
(B) with respect to the new drug involved,
encourage an application for an exemption for
investigational use of the new drug under
regulations issued under section 505(i) of the
Federal Food, Drug, and Cosmetic Act.
(2)(A) The AIDS Research Advisory Committee
established pursuant to section 2304 shall make
recommendations to the Secretary with respect to new
drugs appropriate for determinations described in
paragraph (1).
(B) The Secretary shall, as soon as is practicable,
determine the merits of recommendations received by the
Secretary pursuant to subparagraph (A).
(b) Encouragement of Applications With Respect to Treatment
Use in Circumstances Other Than Clinical Trials.--
(1) In the case of a new drug with respect to which
the Secretary has made a determination described in
subsection (a) and with respect to which an exemption
is in effect for purposes of section 505(i) of the
Federal Food, Drug, and Cosmetic Act, the Secretary
shall--
(A) as appropriate, encourage the sponsor
of the investigation of the new drug to submit
to the Secretary, in accordance with
regulations issued under such section, an
application to use the drug in the treatment of
individuals--
(i) who are infected with the
etiologic agent for acquired immune
deficiency syndrome; and
(ii) who are not participating in
the clinical trials conducted pursuant
to such exemption; and
(B) if such an application is approved,
encourage, as appropriate, licensed medical
practitioners to obtain, in accordance with
such regulations, the new drug from such
sponsor for the purpose of treating such
individuals.
(2) If the sponsor of the investigation of a new
drug described in paragraph (1) does not submit to the
Secretary an application described in such paragraph
(relating to treatment use), the Secretary shall,
through statements published in the Federal Register,
encourage, as appropriate, licensed medical
practitioners to submit to the Secretary such
applications in accordance with regulations described
in such paragraph.
(c) Technical Assistance With Respect to Treatment Use.--In
the case of a new drug with respect to which the Secretary has
made a determination described in subsection (a), the Secretary
may, directly or through grants or contracts, provide technical
assistance with respect to the process of--
(1) submitting to the Secretary applications for
exemptions described in paragraph (1)(B) of such
subsection;
(2) submitting to the Secretary applications
described in subsection (b); and
(3) with respect to sponsors of investigations of
new drugs, facilitating the transfer of new drugs from
such sponsors to licensed medical practitioners.
(d) Definition.--For purposes of this section, the term
``new drug'' has the meaning given such term in section 201 of
the Federal Food, Drug, and Cosmetic Act.
H4 deg.SEC. 2313. [300CC-13] TERRY BEIRN COMMUNITY-BASED
AIDS RESEARCH INITIATIVE.
(a) In General.--After consultation with the Commissioner
of Food and Drugs, the Director of the National Institutes of
Health, acting through the National Institute \1\ of Allergy
and Infectious Diseases, may make grants to public entities and
nonprofit private entities concerned with acquired immune
deficiency syndrome, and may enter into contracts with public
and private such entities, for the purpose of planning and
conducting, in the community involved, clinical trials of
experimental treatments for infection with the etiologic agent
for such syndrome that are approved by the Commissioner of Food
and Drugs for investigational use under regulations issued
under section 505 of the Federal Food, Drug, and Cosmetic Act.
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\1\ So in law. Probably should be ``acting through the Director of
the National Institute''. (Section 2617(b)(1) of Public Law 100-690
expressed the intent to so amend the provision; however, the amendment
cannot be executed because the amendatory instructions are to strike
``through the National Institutes of Allergy'', and this term does not
appear in subsection (a) (above).)
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(b) Requirement of Certain Projects.--
(1) Financial assistance under subsection (a) shall
include such assistance to community-based
organizations and community health centers for the
purpose of--
(A) retaining appropriate medical
supervision;
(B) assisting with administration, data
collection and record management; and
(C) conducting training of community
physicians, nurse practitioners, physicians'
assistants and other health professionals for
the purpose of conducting clinical trials.
(2)(A) Financial assistance under subsection (a)
shall include such assistance for demonstration
projects designed to implement and conduct community-
based clinical trials in order to provide access to the
entire scope of communities affected by infections with
the etiologic agent for acquired immune deficiency
syndrome, including minorities, hemophiliacs and
transfusion-exposed individuals, women, children, users
of intravenous drugs, and individuals who are
asymptomatic with respect to such infection.
(B) The Director of the National Institutes of
Health may not provide financial assistance under this
paragraph unless the application for such assistance is
approved--
(i) by the Commissioner of Food and Drugs;
(ii) by a duly constituted Institutional
Review Board that meets the requirements of
part 56 of title 21, Code of Federal
Regulations; and
(iii) by the Director of the National
Institute of Allergy and Infectious Diseases.
(c) Participation of Private Industry, Schools of Medicine
and Primary Providers.--Programs carried out with financial
assistance provided under subsection (a) shall be designed to
encourage private industry and schools of medicine, osteopathic
medicine, and existing consortia of primary care providers
organized to conduct clinical research concerning acquired
immune deficiency syndrome to participate in, and to support,
the clinical trials conducted pursuant to the programs.
(d) Requirement of Application.--The Secretary may not
provide financial assistance under subsection (a) unless--
(1) an application for the assistance is submitted
to the Secretary;
(2) with respect to carrying out the purpose for
which the assistance is to be made, the application
provides assurances of compliance satisfactory to the
Secretary; and
(3) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this section.
(e) Authorization of Appropriations.--
(1) For the purpose of carrying out subsection
(b)(1), there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
1989 through 1996.
(2) For the purpose of carrying out subsection
(b)(2), there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
1989 through 1996.
SEC. 2314. [300CC-14] EVALUATION OF CERTAIN TREATMENTS.
(a) Establishment of Program.--
(1) After consultation with the AIDS Research
Advisory Committee established pursuant to section
2304, the Secretary shall establish a program for the
evaluation of drugs that--
(A) are not approved by the Commissioner of
Food and Drugs for the purpose of treatments
with respect to acquired immune deficiency
syndrome; and
(B) are being utilized for such purpose by
individuals infected with the etiologic agent
for such syndrome.
(2) The program established under paragraph (1)
shall include evaluations of the effectiveness and the
risks of the treatment involved, including the risks of
foregoing treatments with respect to acquired immune
deficiency syndrome that are approved by the
Commissioner of Food and Drugs.
(b) Authority With Respect to Grants and Contracts.--
(1) For the purpose of conducting evaluations
required in subsection (a), the Secretary may make
grants to, and enter into cooperative agreements and
contracts with, public and nonprofit private entities.
(2) Nonprofit private entities under paragraph (1)
may include nonprofit private organizations that--
(A) are established for the purpose of
evaluating treatments with respect to acquired
immune deficiency syndrome; and
(B) consist primarily of individuals
infected with the etiologic agent for such
syndrome.
(c) Scientific and Ethical Guidelines.--
(1) The Secretary shall establish appropriate
scientific and ethical guidelines for the conduct of
evaluations carried out pursuant to this section. The
Secretary may not provide financial assistance under
subsection (b)(1) unless the applicant for such
assistance agrees to comply with such guidelines.
(2) The Secretary may establish the guidelines
described in paragraph (1) only after consulting with--
(A) physicians whose clinical practice
includes a significant number of individuals
with acquired immune deficiency syndrome;
(B) individuals who are infected with the
etiologic agent for such syndrome; and
(C) other individuals with appropriate
expertise or experience.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary.
SEC. 2315. [300CC-15] SUPPORT OF INTERNATIONAL EFFORTS.
(a) Grants and Contracts for Research.--
(1) Under section 307, the Secretary, acting
through the Director of the National Institutes of
Health--
(A) shall, for the purpose described in
paragraph (2), make grants to, enter into
cooperative agreements and contracts with, and
provide technical assistance to, international
organizations concerned with public health; and
(B) may, for such purpose, provide
technical assistance to foreign governments.
(2) The purpose referred to in paragraph (1) is
promoting and expediting international research and
training concerning the natural history and
pathogenesis of the human immunodeficiency virus and
the development and evaluation of vaccines and
treatments for acquired immune deficiency syndrome and
opportunistic infections.
(b) Grants and Contracts for Additional Purposes.--After
consultation with the Administrator of the Agency for
International Development, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall under section 307 make grants to, enter into contracts
with, and provide technical assistance to, international
organizations concerned with public health and may provide
technical assistance to foreign governments, in order to
support--
(1) projects for training individuals with respect
to developing skills and technical expertise for use in
the prevention, diagnosis, and treatment of acquired
immune deficiency syndrome; and
(2) epidemiological research relating to acquired
immune deficiency syndrome.
(c) Special Programme of World Health Organization.--
Support provided by the Secretary pursuant to this section
shall be in furtherance of the global strategy of the World
Health Organization Special Programme on Acquired
Immunodeficiency Syndrome.
(d) Preferences.--In providing grants, cooperative
agreements, contracts, and technical assistance under
subsections (a) and (b), the Secretary shall--
(1) give preference to activities under such
subsections conducted by, or in cooperation with, the
World Health Organization; and
(2) with respect to activities carried out under
such subsections in the Western Hemisphere, give
preference to activities conducted by, or in
cooperation with, the Pan American Health Organization
or the World Health Organization.
(e) Requirement of Application.--The Secretary may not make
a grant or enter into a cooperative agreement or contract under
this section unless--
(1) an application for such assistance is submitted
to the Secretary;
(2) with respect to carrying out the purpose for
which such assistance is to be provided, the
application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this section.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each fiscal
year.
SEC. 2316. [300CC-16] RESEARCH CENTERS.
(a) In General.--
(1) The Secretary, acting through the Director of
the National Institute of Allergy and Infectious
Diseases, may make grants to, and enter into contracts
with, public and nonprofit private entities to assist
such entities in planning, establishing, or
strengthening, and providing basic operating support
for, centers for basic and clinical research into, and
training in, advanced diagnostic, prevention, and
treatment methods for acquired immune deficiency
syndrome.
(2) A grant or contract under paragraph (1) shall
be provided in accordance with policies established by
the Secretary, acting through the Director of the
National Institutes of Health, and after consultation
with the advisory council for the National Institute of
Allergy and Infectious Diseases.
(3) The Secretary shall ensure that, as
appropriate, clinical research programs carried out
under paragraph (1) include as research subjects women,
children, hemophiliacs, and minorities.
(b) Use of Financial Assistance.--
(1) Financial assistance under subsection (a) may
be expended for--
(A) the renovation or leasing of space;
(B) staffing and other basic operating
costs, including such patient care costs as are
required for clinical research;
(C) clinical training with respect to
acquired immune deficiency syndrome (including
such training for allied health professionals);
and
(D) demonstration purposes, including
projects in the long-term monitoring and
outpatient treatment of individuals infected
with the etiologic agent for such syndrome.
(2) Financial assistance under subsection (a) may
not be expended to provide research training for which
National Research Service Awards may be provided under
section 487.
(c) Duration of Support.--Support of a center under
subsection (a) may be for not more than five years. Such period
may be extended by the Director for additional periods of not
more than five years each if the operations of such center have
been reviewed by an appropriate technical and scientific peer
review group established by the Director and if such group has
recommended to the Director that such period should be
extended.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary.
SEC. 2317. [300CC-17] INFORMATION SERVICES.
(a) Establishment of Program.--The Secretary shall
establish, maintain, and operate a program with respect to
information on research, treatment, and prevention activities
relating to infection with the etiologic agent for acquired
immune deficiency syndrome. The program shall, with respect to
the agencies of the Department of Health and Human Services, be
integrated and coordinated.
(b) Toll-Free Telephone Communications for Health Care
Entities.--
(1) After consultation with the Director of the
Office of AIDS Research, the Administrator of the
Health Resources and Services Administration, and the
Director of the Centers for Disease Control and
Prevention, the Secretary shall provide for toll-free
telephone communications to provide medical and
technical information with respect to acquired immune
deficiency syndrome to health care professionals,
allied health care providers, and to professionals
providing emergency health services.
(2) Information provided pursuant to paragraph (1)
shall include--
(A) information on prevention of exposure
to, and the transmission of, the etiologic
agent for acquired immune deficiency syndrome;
and
(B) information contained in the data banks
established in subsections (c) and (d).
(c) Data Bank on Research Information.--
(1) After consultation with the Director of the
Office of AIDS Research, the Director of the Centers
for Disease Control and Prevention, and the National
Library of Medicine, the Secretary shall establish a
data bank of information on the results of research
with respect to acquired immune deficiency syndrome
conducted in the United States and other countries.
(2) In carrying out paragraph (1), the Secretary
shall collect, catalog, store, and disseminate the
information described in such paragraph. To the extent
practicable, the Secretary shall make such information
available to researchers, physicians, and other
appropriate individuals, of countries other than the
United States.
(d) Data Bank on Clinical Trials and Treatments.--
(1) After consultation with the Commissioner of
Food and Drugs, the AIDS Research Advisory Committee
established under section 2304, and the Director of the
Office of AIDS Research, the Secretary shall, in
carrying out subsection (a), establish a data bank of
information on clinical trials and treatments with
respect to infection with the etiologic agent for
acquired immune deficiency syndrome (hereafter in this
section referred to as the ``Data Bank'').
(2) In carrying out paragraph (1), the Secretary
shall collect, catalog, store, and disseminate the
information described in such paragraph. The Secretary
shall disseminate such information through information
systems available to individuals infected with the
etiologic agent for acquired immune deficiency
syndrome, to other members of the public, to health
care providers, and to researchers.
(e) Requirements With Respect to Data Bank on Clinical
Trials and Treatments.--The Data Bank shall include the
following:
(1) A registry of clinical trials of experimental
treatments for acquired immune deficiency syndrome and
related illnesses conducted under regulations
promulgated pursuant to section 505 of the Federal
Food, Drug and Cosmetic Act that provides a description
of the purpose of each experimental drug protocol
either with the consent of the protocol sponsor, or
when a trial to test efficacy begins. Information
provided shall include eligibility criteria and the
location of trial sites, and must be forwarded to the
Data Bank by the sponsor of the trial not later than 21
days after the approval by the Food and Drug
Administration.
(2) Information pertaining to experimental
treatments for acquired immune deficiency syndrome that
may be available under a treatment investigational new
drug application that has been submitted to the Food
and Drug Administration pursuant to part 312 of title
21, Code of Federal Regulations. The Data Bank shall
also include information pertaining to the results of
clinical trials of such treatments, with the consent of
the sponsor, of such experimental treatments, including
information concerning potential toxicities or adverse
effects associated with the use or administration of
such experimental treatment.
SEC. 2318. [300CC-18] DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE
OF INFECTED INDIVIDUALS.
(a) In General.--
(1) The Secretary, acting through the Director of
the National Institutes of Health and after
consultation with the Administrator for Health Care
Policy and Research, may make grants to public and
nonprofit private entities for the establishment of
projects to develop model protocols for the clinical
care of individuals infected with the etiologic agent
for acquired immune deficiency syndrome, including
treatment and prevention of HIV infection and related
conditions among women.
(2) The Secretary may not make a grant under
paragraph (1) unless--
(A) the applicant for the grant is a
provider of comprehensive primary care; or
(B) the applicant for the grant agrees,
with respect to the project carried out
pursuant to paragraph (1), to enter into a
cooperative arrangement with an entity that is
a provider of comprehensive primary care.
(b) Requirement of Provision of Certain Services.--The
Secretary may not make a grant under subsection (a) unless the
applicant for the grant agrees that, with respect to patients
participating in the project carried out with the grant,
services provided pursuant to the grant will include--
(1) monitoring, in clinical laboratories, of the
condition of such patients;
(2) clinical intervention for infection with the
etiologic agent for acquired immune deficiency
syndrome, including measures for the prevention of
conditions arising from the infection;
(3) information and counseling on the availability
of treatments for such infection approved by the
Commissioner of Food and Drugs, on the availability of
treatments for such infection not yet approved by the
Commissioner, and on the reports issued by the AIDS
Research Advisory Committee under section
2304(c)(2)(B);
(4) support groups; and
(5) information on, and referrals to, entities
providing appropriate social support services.
(c) Limitation on Imposition of Charges for Services.--The
Secretary may not make a grant under subsection (a) unless the
applicant for the grant agrees that, if the applicant will
routinely impose a charge for providing services pursuant to
the grant, the applicant will not impose the charge on any
individual seeking such services who is unable to pay the
charge.
(d) Evaluation and Reports.--
(1) The Secretary may not make a grant under
subsection (a) unless the applicant for the grant
agrees, with respect to the project carried out
pursuant to subsection (a), to submit to the
Secretary--
(A) information sufficient to assist in the
replication of the model protocol developed
pursuant to the project; and
(B) such reports as the Secretary may
require.
(2) The Secretary shall provide for evaluations of
projects carried out pursuant to subsection (a) and
shall annually submit to the Congress a report
describing such projects. The report shall include the
findings made as a result of such evaluations and may
include any recommendations of the Secretary for
appropriate administrative and legislative initiatives
with respect to the program established in this
section.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 1989 through 1991, and such sums as may be
necessary for each of the fiscal years 1994 through 1996.
H4 deg.SEC. 2319. [300CC-19] NATIONAL BLOOD RESOURCE
EDUCATION PROGRAM.
After consultation with the Director of the National Heart,
Lung, and Blood Institute and the Commissioner of Food and
Drugs, the Secretary shall establish a program of research and
education regarding blood donations and transfusions to
maintain and improve the safety of the blood supply. Education
programs shall be directed at health professionals, patients,
and the community to--
(1) in the case of the public and patients
undergoing treatment--
(A) increase awareness that the process of
donating blood is safe;
(B) promote the concept that blood donors
are contributors to a national need to maintain
an adequate and safe blood supply;
(C) encourage blood donors to donate more
than once a year; and
(D) encourage repeat blood donors to
recruit new donors;
(2) in the case of health professionals--
(A) improve knowledge, attitudes, and
skills of health professionals in the
appropriate use of blood and blood components;
(B) increase the awareness and
understanding of health professionals regarding
the risks versus benefits of blood transfusion;
and
(C) encourage health professionals to
consider alternatives to the administration of
blood or blood components for their patients;
and
(3) in the case of the community, increase
coordination, communication, and collaboration among
community, professional, industry, and government
organizations regarding blood donation and transfusion
issues.
SEC. 2320. [300CC-20] ADDITIONAL AUTHORITY WITH RESPECT TO RESEARCH.
(a) Data Collection With Respect to National Prevalence.--
(1) The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may,
through representative sampling and other appropriate
methodologies, provide for the continuous collection of
data on the incidence in the United States of cases of
acquired immune deficiency syndrome and of cases of
infection with the etiologic agent for such syndrome.
The Secretary may carry out the program of data
collection directly or through cooperative agreements
and contracts with public and nonprofit private
entities.
(2) The Secretary shall encourage each State to
enter into a cooperative agreement or contract under
paragraph (1) with the Secretary in order to facilitate
the prompt collection of the most recent accurate data
on the incidence of cases described in such paragraph.
(3) The Secretary shall ensure that data collected
under paragraph (1) includes data on the demographic
characteristics of the population of individuals with
cases described in paragraph (1), including data on
specific subpopulations at risk of infection with the
etiologic agent for acquired immune deficiency
syndrome.
(4) In carrying out this subsection, the Secretary
shall, for the purpose of assuring the utility of data
collected under this section, request entities with
expertise in the methodologies of data collection to
provide, as soon as is practicable, assistance to the
Secretary and to the States with respect to the
development and utilization of uniform methodologies of
data collection.
(5) The Secretary shall provide for the
dissemination of data collected pursuant to this
subsection. In carrying out this paragraph, the
Secretary may publish such data as frequently as the
Secretary determines to be appropriate with respect to
the protection of the public health. The Secretary
shall publish such data not less than once each year.
(b) Epidemiological and Demographic Data.--
(1) The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall
develop an epidemiological data base and shall provide
for long-term studies for the purposes of--
(A) collecting information on the
demographic characteristics of the population
of individuals infected with the etiologic
agent for acquired immune deficiency syndrome
and the natural history of such infection; and
(B) developing models demonstrating the
long-term domestic and international patterns
of the transmission of such etiologic agent.
(2) The Secretary may carry out paragraph (1)
directly or through grants to, or cooperative
agreeements 1 or contracts with, public and
nonprofit private entities, including Federal agencies.
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\1\ So in law. Probably should be ``agreements''.
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(c) Long-Term Research.--The Secretary may make grants to
public and nonprofit private entities for the purpose of
assisting grantees in conducting long-term research into
treatments for acquired immune deficiency syndrome developed
from knowledge of the genetic nature of the etiologic agent for
such syndrome.
(d) Social Sciences Research.--The Secretary, acting
through the Director of the National Institute of Mental
Health, may make grants to public and nonprofit private
entities for the purpose of assisting grantees in conducting
scientific research into the psychological and social sciences
as such sciences relate to acquired immune deficiency syndrome.
(e) Authorization of Appropriations.--
(1) For the purpose of carrying out this section,
there are authorized to be appropriated such sums as
may be necessary for each fiscal year.
(2) Amounts appropriated pursuant to paragraph (1)
to carry out subsection (c) shall remain available
until expended.
H2 deg.Part C--Research Training
SEC. 2341. [300CC-31] FELLOWSHIPS AND TRAINING.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control \2\, shall establish
fellowship and training programs to be conducted by the Centers
for Disease Control \2\ to train individuals to develop skills
in epidemiology, surveillance, testing, counseling, education,
information, and laboratory analysis relating to acquired
immune deficiency syndrome. Such programs shall be designed to
enable health professionals and health personnel trained under
such programs to work, after receiving such training, in
national and international efforts toward the prevention,
diagnosis, and treatment of acquired immune deficiency
syndrome.
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\2\ So in law. Section 312(d)(21) of Public Law 102-531 (106 Stat.
3505) provided that section 2341(a) is amended by striking ``Centers
for Disease Control'' and inserting ``Centers for Disease Control and
Prevention''. The amendment cannot be executed because it does not
specify to which of the instances of such term the amendment applies.
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(b) Programs Conducted by National Institute of Mental
Health.--The Secretary, acting through the Director of the
National Institute of Mental Health, shall conduct or support
fellowship and training programs for individuals pursuing
graduate or postgraduate study in order to train such
individuals to conduct scientific research into the
psychological and social sciences as such sciences relate to
acquired immune deficiency syndrome.
(c) Relationship to Limitation on Number of Employees.--Any
individual receiving a fellowship or receiving training under
subsection (a) or (b) shall not be included in any
determination of the number of full-time equivalent employees
of the Department of Health and Human Services for the purpose
of any limitation on the number of such employees established
by law prior to, on, or after the date of the enactment of the
AIDS Amendments of 1988.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each fiscal
year.
Part D--Office of AIDS Research
Subpart I--Interagency Coordination of Activities
SEC. 2351. [300CC-40] ESTABLISHMENT OF OFFICE.
(a) In General.--There is established within the National
Institutes of Health an office to be known as the Office of
AIDS Research. The Office shall be headed by a director, who
shall be appointed by the Secretary.
(b) Duties.--
(1) Interagency coordination of aids activities.--
With respect to acquired immune deficiency syndrome,
the Director of the Office shall plan, coordinate, and
evaluate research and other activities conducted or
supported by the agencies of the National Institutes of
Health. In carrying out the preceding sentence, the
Director of the Office shall evaluate the AIDS
activities of each of such agencies and shall provide
for the periodic reevaluation of such activities.
(2) Consultations.--The Director of the Office
shall carry out this subpart (including developing and
revising the plan required in section 2353) in
consultation with the heads of the agencies of the
National Institutes of Health, with the advisory
councils of the agencies, and with the advisory council
established under section 2352.
(3) Coordination.--The Director of the Office shall
act as the primary Federal official with responsibility
for overseeing all AIDS research conducted or supported
by the National Institutes of Health, and
(A) shall serve to represent the National
Institutes of Health AIDS Research Program at
all relevant Executive branch task forces and
committees; and
(B) shall maintain communications with all
relevant Public Health Service agencies and
with various other departments of the Federal
Government, to ensure the timely transmission
of information concerning advances in AIDS
research and the clinical treatment of acquired
immune deficiency syndrome and its related
conditions, between these various agencies for
dissemination to affected communities and
health care providers.
SEC. 2351A. [300CC-40A] MICROBICIDE RESEARCH.
(a) Federal Strategic Plan.--The Director of the Office
shall--
(1) expedite the implementation of the Federal
strategic plans required by section 403(a) of the
Public Health Service Act (42 U.S.C. 283(a)(5))
regarding the conduct and support of research on, and
development of, a microbicide to prevent the
transmission of the human immunodeficiency virus; and
(2) review and, as appropriate, revise such plan to
prioritize funding and activities relative to their
scientific urgency and potential market readiness.
(b) Coordination.--In implementing, reviewing, and
prioritizing elements of the plan described in subsection (a),
the Director of the Office shall consult, as appropriate,
with--
(1) representatives of other Federal agencies
involved in microbicide research, including the
Coordinator of United States Government Activities to
Combat HIV/AIDS Globally, the Director of the Centers
for Disease Control and Prevention, and the
Administrator of the United States Agency for
International Development;
(2) the microbicide research and development
community; and
(3) health advocates.
SEC. 2352. [300CC-40A] ADVISORY COUNCIL; COORDINATING COMMITTEES.
(a) Advisory Council.--
(1) In general.--The Secretary shall establish an
advisory council for the purpose of providing advice to
the Director of the Office on carrying out this part.
(Such council is referred to in this subsection as the
``Advisory Council''.)
(2) Composition, compensation, terms, chair, etc.--
Subsections (b) through (g) of section 406 apply to the
Advisory Council to the same extent and in the same
manner as such subsections apply to advisory councils
for the national research institutes, except that--
(A) in addition to the ex officio members
specified in section 406(b)(2), there shall
serve as such members of the Advisory Council a
representative from the advisory council of
each of the National Cancer Institute and the
National Institute on Allergy and Infectious
Diseases; and
(B) with respect to the other national
research institutes, there shall serve as ex
officio members of such Council, in addition to
such members specified in subparagraph (A), a
representative from the advisory council of
each of the 2 institutes that receive the
greatest funding for AIDS activities.
(b) Individual Coordinating Committees Regarding Research
Disciplines.--
(1) In general.--The Director of the Office shall
establish, for each research discipline in which any
activity under the plan required in section 2353 is
carried out, a committee for the purpose of providing
advice to the Director of the Office on carrying out
this part with respect to such discipline. (Each such
committee is referred to in this subsection as a
``coordinating committee''.)
(2) Composition.--Each coordinating committee shall
be composed of representatives of the agencies of the
National Institutes of Health with significant
responsibilities regarding the research discipline
involved.
SEC. 2353. [300CC-40B] COMPREHENSIVE PLAN FOR EXPENDITURE OF
APPROPRIATIONS.
(a) In General.--Subject to the provisions of this section
and other applicable law, the Director of the Office, in
carrying out section 2351, shall--
(1) establish a comprehensive plan for the conduct
and support of all AIDS activities of the agencies of
the National Institutes of Health (which plan shall be
first established under this paragraph not later than
12 months after the date of the enactment of the
National Institutes of Health Revitalization Act of
1993); \1\
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\1\ Enacted June 10, 1993.
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(2) ensure that the Plan establishes priorities
among the AIDS activities that such agencies are
authorized to carry out;
(3) ensure that the Plan establishes objectives
regarding such activities, describes the means for
achieving the objectives, and designates the date by
which the objectives are expected to be achieved;
(4) ensure that all amounts appropriated for such
activities are expended in accordance with the Plan;
(5) review the Plan not less than annually, and
revise the Plan as appropriate; and
(6) ensure that the Plan serves as a broad, binding
statement of policies regarding AIDS activities of the
agencies, but does not remove the responsibility of the
heads of the agencies for the approval of specific
programs or projects, or for other details of the daily
administration of such activities, in accordance with
the Plan.
(b) Certain Components of Plan.--With respect to AIDS
activities of the agencies of the National Institutes of
Health, the Director of the Office shall ensure that the Plan--
(1) provides for basic research;
(2) provides for applied research;
(3) provides for research that is conducted by the
agencies;
(4) provides for research that is supported by the
agencies;
(5) provides for proposals developed pursuant to
solicitations by the agencies and for proposals
developed independently of such solicitations; and
(6) provides for behavioral research and social
sciences research.
(c) Budget Estimates.--
(1) Full-funding budget.--
(A) With respect to a fiscal year, the
Director of the Office shall prepare and submit
directly to the President, for review and
transmittal to the Congress, a budget estimate
for carrying out the Plan for the fiscal year,
after reasonable opportunity for comment (but
without change) by the Secretary, the Director
of the National Institutes of Health, and the
advisory council established under section
2352. The budget estimate shall include an
estimate of the number and type of personnel
needs for the Office.
(B) The budget estimate submitted under
subparagraph (A) shall estimate the amounts
necessary for the agencies of the National
Institutes of Health to carry out all AIDS
activities determined by the Director of the
Office to be appropriate, without regard to the
probability that such amounts will be
appropriated.
(2) Alternative budgets.--
(A) With respect to a fiscal year, the
Director of the Office shall prepare and submit
to the Secretary and the Director of the
National Institutes of Health the budget
estimates described in subparagraph (B) for
carrying out the Plan for the fiscal year. The
Secretary and such Director shall consider each
of such estimates in making recommendations to
the President regarding a budget for the Plan
for such year.
(B) With respect to the fiscal year
involved, the budget estimates referred to in
subparagraph (A) for the Plan are as follows:
(i) The budget estimate submitted
under paragraph (1).
(ii) A budget estimate developed on
the assumption that the amounts
appropriated will be sufficient only
for--
(I) continuing the conduct
by the agencies of the National
Institutes of Health of
existing AIDS activities (if
approved for continuation), and
continuing the support of such
activities by the agencies in
the case of projects or
programs for which the agencies
have made a commitment of
continued support; and
(II) carrying out, of
activities that are in addition
to activities specified in
subclause (I), only such
activities for which the
Director determines there is
the most substantial need.
(iii) Such other budget estimates
as the Director of the Office
determines to be appropriate.
(d) Funding.--
(1) Authorization of appropriations.--For the
purpose of carrying out AIDS activities under the Plan,
there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 1994
through 1996.
(2) Receipt of funds.--For the first fiscal year
beginning after the date on which the Plan first
established under section 2353(a)(1) has been in effect
for 12 months, and for each subsequent fiscal year, the
Director of the Office shall receive directly from the
President and the Director of the Office of Management
and Budget all funds available for AIDS activities of
the National Institutes of Health.
(3) Allocations for agencies.--
(A) Each fiscal year the Director of the
Office shall, from the amounts received under
paragraph (2) for the fiscal year, allocate to
the agencies of the National Institutes of
Health (in accordance with the Plan) all
amounts available for such year for carrying
out the AIDS activities specified in subsection
(c)(2)(B)(ii)(I) for such year. Such allocation
shall, to the extent practicable, be made not
later than 15 days after the date on which the
Director receives amounts under paragraph (2).
(B) Each fiscal year the Director of the
Office shall, from the amounts received under
paragraph (2) for the fiscal year, allocate to
the agencies of the National Institutes of
Health (in accordance with the Plan) all
amounts available for such year for carrying
out AIDS activities that are not referred to in
subparagraph (A). Such allocation shall, to the
extent practicable, be made not later than 30
days after the date on which the Director
receives amounts under paragraph (2).
SEC. 2354. [300CC-41] ADDITIONAL AUTHORITIES.
(a) In General.--In carrying out AIDS research, the
Director of the Office--
(1) shall develop and expand clinical trials of
treatments and therapies for infection with the
etiologic agent for acquired immune deficiency
syndrome, including such clinical trials for women,
infants, children, hemophiliacs, and minorities;
(2) may establish or support the large-scale
development and preclinical screening, production, or
distribution of specialized biological materials and
other therapeutic substances for AIDS research and set
standards of safety and care for persons using such
materials;
(3) may support--
(A) AIDS research conducted outside the
United States by qualified foreign
professionals if such research can reasonably
be expected to benefit the people of the United
States;
(B) collaborative research involving
American and foreign participants; and
(C) the training of American scientists
abroad and foreign scientists in the United
States;
(4) may encourage and coordinate AIDS research
conducted by any industrial concern that evidences a
particular capability for the conduct of such research;
(5)(A) may acquire, improve, repair, operate, and
maintain laboratories, other research facilities,
equipment, and such other real or personal property as
the Director of the Office determines necessary;
(B) may make grants for the construction or
renovation of facilities; and
(C) may acquire, without regard to the Act of March
3, 1877 (40 U.S.C. 34) by lease or otherwise through
the Administrator of General Services, buildings or
parts of buildings in the District of Columbia or
communities located adjacent to the District of
Columbia for the use of the National Institutes of
Health for a period not to exceed ten years; and
(6) subject to section 405(b)(2) and without regard
to section 3324 of title 31, United States Code, and
section 3709 of the Revised Statutes (41 U.S.C. 5), may
enter into such contracts and cooperative agreements
with any public agency, or with any person, firm,
association, corporation, or educational institution,
as may be necessary to expedite and coordinate research
relating to acquired immune deficiency syndrome.
(b) Projects for Cooperation Among Public and Private
Health Entities.--In carrying out subsection (a), the Director
of the Office shall establish projects to promote cooperation
among Federal agencies, State, local, and regional public
health agencies, and private entities, in research concerning
the diagnosis, prevention, and treatment of acquired immune
deficiency syndrome.
Subpart II--Emergency Discretionary Fund
SEC. 2356. [300CC-43] EMERGENCY DISCRETIONARY FUND.
(a) In General.--
(1) Establishment.--There is established a fund
consisting of such amounts as may be appropriated under
subsection (g). Subject to the provisions of this
section, the Director of the Office, after consultation
with the advisory council established under section
2352, may expend amounts in the Fund for the purpose of
conducting and supporting such AIDS activities,
including projects of AIDS research, as may be
authorized in this Act for the National Institutes of
Health.
(2) Preconditions to use of fund.--Amounts in the
Fund may be expended only if--
(A) the Director identifies the particular
set of AIDS activities for which such amounts
are to be expended;
(B) the set of activities so identified
constitutes either a new project or additional
AIDS activities for an existing project;
(C) the Director of the Office has made a
determination that there is a significant need
for such set of activities; and
(D) as of June 30 of the fiscal year
preceding the fiscal year in which the
determination is made, such need was not
provided for in any appropriations Act passed
by the House of Representatives to make
appropriations for the Departments of Labor,
Health and Human Services (including the
National Institutes of Health), Education, and
related agencies for the fiscal year in which
the determination is made.
(3) Two-year use of fund for project involved.--In
the case of an identified set of AIDS activities,
obligations of amounts in the Fund may not be made for
such set of activities after the expiration of the 2-
year period beginning on the date on which the initial
obligation of such amounts is made for such set.
(b) Peer Review.--With respect to an identified set of AIDS
activities carried out with amounts in the Fund, this section
may not be construed as waiving applicable requirements for
peer review.
(c) Limitations on Use of Fund.--
(1) Construction of facilities.--Amounts in the
Fund may not be used for the construction, renovation,
or relocation of facilities, or for the acquisition of
land.
(2) Congressional disapproval of projects.--
(A) Amounts in the Fund may not be expended
for the fiscal year involved for an identified
set of AIDS activities, or a category of AIDS
activities, for which--
(i)(I) amounts were made available
in an appropriations Act for the
preceding fiscal year; and
(II) amounts are not made available
in any appropriations Act for the
fiscal year involved; or
(ii) amounts are by law prohibited
from being expended.
(B) A determination under subparagraph
(A)(i) of whether amounts have been made
available in appropriations Acts for a fiscal
year shall be made without regard to whether
such Acts make available amounts for the Fund.
(3) Investment of fund amounts.--Amounts in the
Fund may not be invested.
(d) Applicability of Limitation Regarding Number of
Employees.--The purposes for which amounts in the Fund may be
expended include the employment of individuals necessary to
carry out identified sets of AIDS activities approved under
subsection (a). Any individual employed under the preceding
sentence may not be included in any determination of the number
of full-time equivalent employees for the Department of Health
and Human Services for the purpose of any limitation on the
number of such employees established by law prior to, on, or
after the date of the enactment of the National Institutes of
Health Revitalization Act of 1993. \1\
(e) Definitions.--For purposes of this section:
(1) The term ``Fund'' means the fund established in
subsection (a).
(2) The term ``identified set of AIDS activities''
means a particular set of AIDS activities identified
under subsection (a)(2)(A).
(f) Funding.--
(1) Authorization of appropriations.--For the
purpose of providing amounts for the Fund, there is
authorized to be appropriated $100,000,000 for each of
the fiscal years 1994 through 1996.
(2) Availability.--Amounts appropriated for the
Fund are available until expended.
Subpart III--General Provisions
SEC. 2359. [300CC-45] GENERAL PROVISIONS REGARDING THE OFFICE.
(a) Administrative Support for Office.--The Secretary,
acting through the Director of the National Institutes of
Health, shall provide administrative support and support
services to the Director of the Office and shall ensure that
such support takes maximum advantage of existing administrative
structures at the agencies of the National Institutes of
Health.
(b) Evaluation.--Not later than 5 years after the date of
the enactment of National Institutes of Health Revitalization
Act of 1993, \1\ the Secretary shall conduct an evaluation to--
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\1\ Enacted June 10, 1993.
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(1) determine the effect of this section on the
planning and coordination of the AIDS research programs
at the institutes, centers and divisions of the
National Institutes of Health;
(2) evaluate the extent to which this part has
eliminated the duplication of administrative resources
among such Institutes, centers and divisions; and
(3) provide recommendations concerning future
alterations with respect to this part.
(c) Definitions.--For purposes of this part:
(1) The term ``AIDS activities'' means AIDS
research and other activities that relate to acquired
immune deficiency syndrome.
(2) The term ``AIDS research'' means research with
respect to acquired immune deficiency syndrome.
(3) The term ``Office'' means the Office of AIDS
Research.
(4) The term ``Plan'' means the plan required in
section 2353(a)(1).
Part E--General Provisions
SEC. 2361. [300CC-51] DEFINITION.
For purposes of this title:
(1) The term ``infection'', with respect to the
etiologic agent for acquired immune deficiency
syndrome, includes opportunistic cancers and infectious
diseases and any other conditions arising from
infection with such etiologic agent.
(2) The term ``treatment'', with respect to the
etiologic agent for acquired immune deficiency
syndrome, includes primary and secondary
prophylaxis.ATTORNEY: PMG/FD (June 22,
1999) deg.
H1 deg.TITLE XXIV--HEALTH SERVICES WITH RESPECT TO ACQUIRED
IMMUNE DEFICIENCY SYNDROME \1\
H2 deg.Part A--Formula Grants to States for Home and
Community-Based Health Services
H4 deg.SEC. 2401. [300DD] ESTABLISHMENT OF PROGRAM.
(a) Allotments for States.--For the purpose described in
subsection (b), the Secretary shall for each of the fiscal
years 1989 and 1990 make an allotment for each State in an
amount determined in accordance with section 2408. The
Secretary shall make payments each such fiscal year to each
State from the allotment for the State if the Secretary
approves for the fiscal year involved an application submitted
by the State pursuant to section 2407.
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\1\ See footnote at beginning of title XXIII.
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(b) Purpose of Grants.--The Secretary may not make payments
under subsection (a) for a fiscal year unless the State
involved agrees to expend the payments only for the purpose of
providing services in accordance with section 2402.
(c) Eligible Individual Defined.--For purposes of this
part:
(1) The term ``eligible individual'' means an
individual infected with the etiologic agent for
acquired immune deficiency syndrome who either is
medically dependent or chronically dependent.
(2) The term ``medically dependent'' means, with
respect to an individual, that the individual has been
certified by a physician as--
(A) requiring the routine use of
appropriate medical services (which may include
home intravenous drug therapy) to prevent or
compensate for the individual's serious
deterioration, arising from infection with the
etiologic agent for acquired immune deficiency
syndrome, of physical health or cognitive
function, and
(B) being able to avoid long-term or
repeated care as an inpatient or resident in a
hospital, nursing facility, or other
institution if home and community-based health
services are provided to the individual.
(3) The term ``chronically dependent'' means, with
respect to an individual, that the individual has been
certified by a physician as--
(A) being unable to perform, because of
physical or cognitive impairment (without
substantial assistance from another individual)
arising from infection with the etiologic agent
for acquired immune deficiency syndrome, at
least 2 of the following activities of daily
living: bathing, dressing, toileting,
transferring, and eating, or
(B) having a similar level of disability
due to cognitive impairment (as defined by the
Secretary).
(d) Home and Community-Based Health Services Defined.--For
purposes of this part, the term ``home and community-based
health services''--
(1) means, with respect to an eligible individual,
skilled health services furnished to the individual in
the individual's home pursuant to a written plan of
care established by a health care professional for the
provision of such services and items and services
described in paragraph (2);
(2) includes--
(A) durable medical equipment,
(B) homemaker/home health aide services and
personal care services furnished in the
individual's home,
(C) day treatment or other partial
hospitalization services,
(D) home intravenous drug therapy
(including prescription drugs administered
intravenously as part of such therapy), and
(E) routine diagnostic tests administered
in the individual's home,
furnished pursuant to such plan of care; but
(3) does not include, except as specifically
provided in paragraph (2)--
(A) diagnostic tests,
(B) inpatient hospital services,
(C) nursing facility services, and
(D) prescription drugs.
SEC. 2402. [300DD-1] PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF
GRANTS.
(a) Required Uses of Funds.--The Secretary may not make
payments under section 2401(a) unless the State involved agrees
that the State will--
(1) provide for home and community-based health
services for eligible individuals pursuant to written
plans of care established by health care professionals
for providing such services to such individuals;
(2) provide for the identification, location, and
provision of outreach to eligible individuals;
(3) provide for coordinating the provision of
services under this part with the provision of similar
or related services by public and private entities; and
(4) give priority to the provision of outreach and
home and community-based services to eligible
individuals with low incomes.
(b) Authority for Grants and Contracts.--A State may make
payment for services under subsection (a) through grants to
public and nonprofit private entities and through contracts
with public and private entities. In providing such financial
assistance, a State shall give priority to public and nonprofit
private entities that have demonstrated experience in
delivering home and community-based health services to
individuals infected with the etiologic agent for acquired
immune deficiency syndrome.
SEC. 2403. [300DD-2] REQUIREMENT OF SUBMISSION OF DESCRIPTION OF
INTENDED USES OF GRANT.
The Secretary may not make payments under section 2401(a)
to a State for a fiscal year unless--
(1) the State submits to the Secretary a
description of the purposes for which the State intends
to expend such payments for the fiscal year;
(2) such description provides information relating
to the services and activities to be provided,
including a description of the manner in which such
services and activities will be coordinated with any
similar services and activities of public and private
entities; and
(3) such description includes information relating
to (A) the process for determining which eligible
individuals are medically dependent or chronically
dependent and (B) the process for establishing written
plans of care for the provision of home and community-
based health services under this part.
H4 deg.SEC. 2404. [300DD-3] RESTRICTIONS ON USE OF GRANT.
(a) In General.--The Secretary may not make payments under
section 2401(a) for a fiscal year to a State unless the State
agrees that the payments will not be expended--
(1) to provide for items or services described in
section 2401(d)(3);
(2) to make cash payments to intended recipients of
services;
(3) to purchase or improve real property (other
than minor remodeling of existing improvements to real
property) or to purchase major medical equipment; or
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds.
(b) Limitation on Administrative Expenses.--The Secretary
may not make payments under section 2401(a) for a fiscal year
unless the State involved agrees that the State will not expend
more than 5 percent of the payments made to the State under
such section for administrative expenses with respect to
carrying out the purpose of this part.
(c) Limitation on Total Payments.--
(1) Before March 1, 1989, for fiscal year 1989 and
before September 1, 1989, for fiscal year 1990, the
Secretary shall determine and publish the national
average monthly payments, for extended care services
under part A of title XVIII of the Social Security Act,
for each resident of a skilled nursing facility the
Secretary estimates will be paid in the fiscal year.
(2) The Secretary may not make payments under
section 2401(a) for a fiscal year to a State to the
extent that the average monthly payments for eligible
individuals provided home and community-based health
services under this part in the State exceeds 65
percent of the national average monthly payments
determined and published for the fiscal year under
paragraph (1).
H4 deg.SEC. 2405. [300DD-4] REQUIREMENT OF REPORTS AND
AUDITS BY STATES.
(a) Reports.--
(1) The Secretary may not make payments under
section 2401(a) for a fiscal year unless the State
involved agrees to prepare and submit to the Secretary,
by not later than January 1 following the fiscal year,
an annual report in such form and containing such
information as the Secretary determines (after
consultation with the States and the Comptroller
General of the United States) to be necessary for--
(A) securing a record and a description of
the purposes for which payments received by the
State pursuant to section 2401(a) were expended
and of the recipients of such payments;
(B) determining whether the payments were
expended in accordance with the purpose of this
part; and
(C) determining the percentage of payments
received pursuant to section 2401(a) that were
expended by the State for administrative
expenses during the fiscal year involved.
(2) Each report by a State under paragraph (1) for
a fiscal year also shall include--
(A) information on the number and type of
eligible individuals provided home and
community-based health services by the State
under this part for the fiscal year;
(B) information on the types of home and
community-based health services so provided;
(C) information on the average monthly
costs of such services and a comparison of such
costs with costs of providing services in
hospitals, nursing facilities, and similar
institutions; and
(D) such other information as the Secretary
may require to provide for an evaluation of the
program under this part and its cost-
effectiveness.
(b) Audits.--
(1) The Secretary may not make payments under
section 2401(a) for a fiscal year unless the State
involved agrees to establish such fiscal control and
fund accounting procedures as may be necessary to
ensure the proper disbursal of, and accounting for,
amounts received by the State under such section.
(2) The Secretary may not make payments under
section 2401(a) for a fiscal year unless the State
involved agrees that--
(A) the State will provide for--
(i) a financial and compliance
audit of such payments; or
(ii) a single financial and
compliance audit of each entity
administering such payments;
(B) the audit will be performed biennially
and will cover expenditures in each fiscal
year; and
(C) the audit will be conducted in
accordance with standards established by the
Comptroller General of the United States for
the audit of governmental organizations,
programs, activities, and functions.
(3) The Secretary may not make payments under
section 2401(a) for a fiscal year unless the State
involved agrees that, not later than 30 days after the
completion of an audit under paragraph (2), the State
will provide a copy of the audit report to the State
legislature.
(4) For purposes of paragraph (2), the term
``financial and compliance audit'' means an audit to
determine whether the financial statements of an
audited entity present fairly the financial position,
and the results of financial operations, of the entity
in accordance with generally accepted accounting
principles, and whether the entity has complied with
laws and regulations that may have a material effect
upon the financial statements.
(c) Availability to Public.--The Secretary may not make
payments under section 2401(a) unless the State involved agrees
to make copies of the reports and audits described in this
section available for public inspection.
(d) Evaluations by Comptroller General.--The Comptroller
General of the United States shall, from time to time, evaluate
the expenditures by the States of payments under section
2401(a) in order to assure that expenditures are consistent
with the provisions of this part.
H4 deg.SEC. 2406. [300DD-5] ADDITIONAL REQUIRED AGREEMENTS.
(a) \1\ In General.--The Secretary may not make payments
under section 2401(a) for a fiscal year unless the State
involved agrees that--
---------------------------------------------------------------------------
\1\ So in law. This section does not contain a subsection (b).
---------------------------------------------------------------------------
(1) the legislature of the State will conduct
public hearings on the proposed use and distribution of
the payments to be received from the allotments for
each such fiscal year;
(2)(A) the State will, to the maximum extent
practicable, ensure that services provided to an
individual pursuant to the program involved will be
provided without regard to the ability of the
individual to pay for such services and without regard
to the current or past health condition of the
individual;
(B) if any charges are imposed for the provision of
home and community-based health services for which
assistance is provided under this part, such charges
(i) will be pursuant to a public schedule of charges,
(ii) will not be imposed on any eligible individual
with an income that does not exceed 100 percent of the
official poverty line, and (iii) for an eligible
individual with an income that exceeds 100 percent of
the official poverty line, will be adjusted to reflect
the income of the individual;
(3) the State will provide for periodic independent
peer review to assess the quality and appropriateness
of home and community-based health services provided by
entities that receive funds from the State pursuant to
section 2401(a);
(4) the State will permit and cooperate with
Federal investigations undertaken under section
2409(e);
(5) the State will maintain State expenditures for
home and community-based health services for
individuals infected with the etiologic agent for
acquired immune deficiency syndrome at a level equal to
not less than the average level of such expenditures
maintained by the State for the 2-year period preceding
the fiscal year for which the State is applying to
receive payments; and
(6) the State will not make payments from
allotments made under section 2401(a) for any item or
service to the extent that payment has been made, or
can reasonably be expected to be made, with respect to
that item or service (i) under any State compensation
program, under an insurance policy, under any Federal
or State health benefits program, or (ii) by an entity
that provides health services on a prepaid basis.
SEC. 2407. [300DD-6] REQUIREMENT OF SUBMISSION OF APPLICATION
CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
The Secretary may not make payments under section 2401(a)
to a State for a fiscal year unless--
(1) the State submits to the Secretary an
application for the payments containing agreements in
accordance with sections 2401 through 2406;
(2) the agreements are made through certification
from the chief executive officer of the State;
(3) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary;
(4) the application contains the description of
intended expenditures required in section 2403; and
(5) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this part.
H4 deg.SEC. 2408. [300DD-7] DETERMINATION OF AMOUNT OF
ALLOTMENTS FOR STATES.
(a) Minimum Allotment.--Subject to the extent of amounts
made available in appropriations Acts, the amount of an
allotment under section 2401(a) for--
(1) each of the several States, the District of
Columbia, and the Commonwealth of Puerto Rico, for a
fiscal year shall be the greater of--
(A) $100,000, and
(B) an amount determined under subsection
(b); and
(2) each territory of the United States (as defined
in section 2413(5)) shall be $25,000.
(b) Determination Under Formula.--
(1) The amount referred to in subsection (a)(1)(B)
for a State is the product of--
(A) an amount equal to the amount
appropriated pursuant to section 2414(a) for
the fiscal year involved; and
(B) the ratio of the distribution factor
for the State to the sum of the distribution
factors for all the States.
(2) In paragraph (1)(B), the term ``distribution
factor'' means, for a State, the product of--
(A) the number in the State of additional
cases of acquired immune deficiency syndrome,
as indicated by the number of such cases
reported to and confirmed by the Secretary for
the most recent fiscal year for which such data
are available, and
(B) the ratio (based on the most recent
available data) of (i) the average per capita
income of individuals in the United States to
(ii) the average per capita income of
individuals in the State;
except that the distribution factors for all the States
and territories shall be proportionally reduced to the
extent necessary to assure that the total of the
allotments under subsection (a) for all the States and
territories for each fiscal year does not exceed the
amount appropriated pursuant to section 2414(a) for the
fiscal year.
(c) Indian Tribes.--
(1) Upon the request of the governing body of an
Indian tribe or tribal organization within a State to
the Secretary, the Secretary shall--
(A) reserve from the amount that otherwise
would be allotted for the fiscal year to the
State under subsection (a) an amount determined
in accordance with paragraph (2); and
(B) grant the amount reserved under
subparagraph (A) to the Indian tribe or tribal
organization serving eligible individuals who
are members of the Indian tribe or tribal
organization.
(2) The amount reserved under paragraph (1)(A)
shall be an amount equal to the product of--
(A) the amount that otherwise would be
allotted to the State under subsection (a) for
the fiscal year; and
(B) the Secretary's estimate of the
proportion of the number of additional cases
described in subsection (b)(2)(A) that are
attributable to members of the Indian tribe or
tribal organization.
(3) The Secretary may not make a grant under
paragraph (1)(B) to an Indian tribe or tribal
organization unless the Indian tribe or tribal
organization submits to the Secretary an application
meeting the requirements of such an application under
section 2407.
(d) Disposition of Certain Funds Appropriated for
Allotments.--
(1) Amounts described in paragraph (2) shall, in
accordance with paragraph (3), be allotted by the
Secretary to States receiving payments under section
2401(a) for the fiscal year (other than any State
referred to in paragraph (2)(B)).
(2) The amounts referred to in paragraph (1) are
any amounts that are not paid to States or territories
under section 2401(a) as a result of--
(A) the failure of any State or territory
to submit an application under section 2407
within a reasonable time period established by
the Secretary; or
(B) any State or territory informing the
Secretary that the State or territory does not
intend to expend the full amount of the
allotment made to the State or territory.
(3) The amount of an allotment under paragraph (1)
for a State for a fiscal year shall be an amount equal
to the product of--
(A) an amount equal to the amount described
in paragraph (2) for the fiscal year involved;
and
(B) the ratio determined under subsection
(b)(1)(B) for the State.
H4 deg.SEC. 2409. [300DD-8] FAILURE TO COMPLY WITH
AGREEMENTS.
(a) Repayment of Payments.--
(1) The Secretary may, subject to subsection (c),
require a State to repay any payments received by the
State under section 2401(a) that the Secretary
determines were not expended by the State in accordance
with the agreements required to be contained in the
application submitted by the State pursuant to section
2407.
(2) If a State fails to make a repayment required
in paragraph (1), the Secretary may offset the amount
of the repayment against the amount of any payment due
to be paid to the State under section 2401(a).
(b) Withholding of Payments.--
(1) The Secretary may, subject to subsection (c),
withhold payments due under section 2401(a) if the
Secretary determines that the State involved is not
expending amounts received under such section in
accordance with the agreements required to be contained
in the application submitted by the State pursuant to
section 2407.
(2) The Secretary shall cease withholding payments
from a State under paragraph (1) if the Secretary
determines that there are reasonable assurances that
the State will expend amounts received under section
2401(a) in accordance with the agreements referred to
in such paragraph.
(c) Opportunity for Hearing.--Before requiring repayment of
payments under subsection (a)(1), or withholding payments under
subsection (b)(1), the Secretary shall provide to the State an
opportunity for a hearing conducted within the State.
(d) Technical Violations.--The Secretary may not require
repayment under subsection (a)(1), or withhold payments under
subsection (b)(1), for a technical violation, as determined by
the Secretary, of any agreement required to be contained in the
application submitted by the State pursuant to section 2407.
(e) Investigations.--
(1) The Secretary shall conduct in several States
in each fiscal year investigations of the expenditure
of payments received by the States under section
2401(a) in order to evaluate compliance with the
agreements required to be contained in the applications
submitted to the Secretary pursuant to section 2407.
(2) Each State, and each entity receiving funds
from payments made to a State under section 2401(a),
shall make appropriate books, documents, papers, and
records available to the Secretary and the Comptroller
General of the United States, or any of their duly
authorized representatives, for examination, copying,
or mechanical reproduction on or off the premises of
the appropriate entity upon a reasonable request
therefor.
(3)(A) In conducting any investigation in a State,
the Secretary and the Comptroller General of the United
States may not make a request for any information not
readily available to the State, or to an entity
receiving funds from payments made to the State under
section 2401(a), or make an unreasonable request for
information to be compiled, collected, or transmitted
in any form not readily available.
(B) Subparagraph (A) shall not apply to the
collection, compilation, or transmittal of data in the
course of a judicial proceeding.
H4 deg.SEC. 2410. [300DD-9] PROHIBITION AGAINST CERTAIN
FALSE STATEMENTS.
(a) In General.--A person may not knowingly make or cause
to be made any false statement or representation of a material
fact in connection with the furnishing of items or services for
which amounts may be paid by a State from payments received by
the State under section 2401(a).
(b) Criminal Penalty for Violation of Prohibition.--Any
person who violates a prohibition established in subsection (a)
may for each violation be fined in accordance with title 18,
United States Code, or imprisoned for not more than 5 years, or
both.
SEC. 2411. [300DD-10] TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY
OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
(a) Technical Assistance.--Upon the request of a State
receiving payments under section 2401(a), the Secretary may,
without charge to the State, provide to the State (or to any
public or private entity designated by the State) technical
assistance with respect to the planning, development, and
operation of any program or service carried out pursuant to
this part. The Secretary may provide such technical assistance
directly, through contract, or through grants.
(b) Provision by Secretary of Supplies and Services in Lieu
of Grant Funds.--
(1) Upon the request of a State receiving payments
under section 2401(a), the Secretary may, subject to
paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the State in
carrying out this part and, for such purpose, may
detail to the State any officer or employee of the
Department of Health and Human Services.
(2) With respect to a request described in
paragraph (1), the Secretary shall reduce the amount of
payments under section 2401(a) to the State by an
amount equal to the costs of detailing personnel and
the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary
shall, for the payment of expenses incurred in
complying with such request, expend the amounts
withheld.
H4 deg.SEC. 2412. [300DD-11] REPORT BY SECRETARY.
Not later than March 1, 1990, the Secretary shall report to
the Congress on the activities of the States under this part.
Such report shall include a recommendation as to whether or not
the program under this part should be extended beyond fiscal
year 1990 and may include any recommendations of the Secretary
for appropriate administrative and legislative initiatives.
H4 deg.SEC. 2413. [300DD-12] DEFINITIONS.
For purposes of this part:
(1) The terms ``Indian tribe'' and ``tribal
organization'' have the same meaning given such terms
in sections 4(b) and 4(c) of the Indian Self-
Determination and Education Assistance Act.
(2) The term ``infected with the etiologic agent
for acquired immune deficiency syndrome'' includes any
condition arising from infection with such etiologic
agent.
(3)(A) An individual is considered to have low
income if the individual's income does not exceed 200
percent of the official poverty line.
(B) The term ``official poverty line'' refers, with
respect to an individual, to the official poverty line
defined by the Office of Management and Budget, and
revised annually in accordance with section 673(2) of
the Omnibus Budget Reconciliation Act of 1981,
applicable to a family of the size involved.
(4)(A) The term ``State'' means, except as provided
in subparagraph (B), each of the several States, the
District of Columbia, the Commonwealth of Puerto Rico,
and each territory of the United States.
(B) For purposes of subsections (b) and (d) of
section 2408, the term ``State'' means each of the
several States, the District of Columbia, and the
Commonwealth of Puerto Rico.
(5) The term ``territory of the United States''
means each of the following: the Virgin Islands, Guam,
American Samoa, and the Commonwealth of the Northern
Mariana Islands.
H4 deg.SEC. 2414. [300DD-13] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
making allotments under section 2401(a), there are authorized
to be appropriated $100,000,000 for each of the fiscal years
1989 and 1990.
(b) Availability to States.--Any amounts paid to a State or
territory under section 2401(a) shall remain available to the
State or territory until the expiration of the 1-year period
beginning on the date on which the State or territory receives
such amounts.
H4 deg.SEC. 2415. [300DD-14] SUNSET.
Effective with respect to appropriations made for any
period after fiscal year 1990, this part is repealed.
H2 deg.Part B--Subacute Care
H4 deg.SEC. 2421. [300DD-21] DEMONSTRATION PROJECTS.
(a) As used in this section:
(1) The term ``individuals infected with the
etiologic agent for acquired immune deficiency
syndrome'' means individuals who have a disease, or are
recovering from a disease, attributable to the
infection of such individuals with such etiologic
agent, and as a result of the effects of such disease,
are in need of subacute-care services.
(2) The term ``subacute care'' means medical and
health care services that are required for individuals
recovering from acute care episodes that are less
intensive than the level of care provided in acute-care
hospitals, and includes skilled nursing care, hospice
care, and other types of health services provided in
other long-term-care facilities.
(b) The Secretary shall conduct three demonstration
projects to determine the effectiveness and cost of providing
the subacute-care services described in subsection (b) to
individuals infected with the etiologic agent for acquired
immune deficiency syndrome, and the impact of such services on
the health status of such individuals.
(c)(1) The services provided under each demonstration
project shall be designed to meet the specific needs of
individuals infected with the etiologic agent for acquired
immune deficiency syndrome, and shall include--
(A) the care and treatment of such individuals by
providing--
(i) subacute care;
(ii) emergency medical care and specialized
diagnostic and therapeutic services as needed
and where appropriate, either directly or
through affiliation with a hospital that has
experience in treating individuals with
acquired immune deficiency syndrome; and
(iii) case management services to ensure,
through existing services and programs whenever
possible, appropriate discharge planning for
such individuals; and
(B) technical assistance, to other facilities in
the region served by such facility, that is directed
toward education and training of physicians, nurses,
and other health-care professionals in the subacute
care and treatment of individuals infected with the
etiologic agent for acquired immune deficiency
syndrome.
(2) Services provided under each demonstration project may
also include--
(A) hospice services;
(B) outpatient care; and
(C) outreach activities in the surrounding
community to hospitals and other health-care facilities
that serve individuals infected with the etiologic
agent for acquired immune deficiency syndrome.
(d) The demonstration projects shall be conducted--
(1) during a 4-year period beginning not later than
9 months after the date of enactment of this section;
\1\ and
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\1\ Enacted on November 4, 1988.
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(2) at sites that--
(A) are geographically diverse and located
in areas that are appropriate for the provision
of the required and authorized services; and
(B) have the highest incidence of cases of
acquired immune deficiency syndrome and the
greatest need for subacute-care services.
(e) The Secretary shall evaluate the operations of the
demonstration projects and shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Labor and Human Resources of the Senate--
(1) not later than 18 months after the beginning of
the first project, a preliminary report that contains--
(A) a description of the sites at which the
projects are being conducted and of the
services being provided in each project; and
(B) a preliminary evaluation of the
experience of the projects in the first 12
months of operation; and
(2) not later than 6 months after the completion of
the last project, a final report that contains--
(A) an assessment of the costs of subacute
care for individuals infected with the
etiologic agent for acquired immune deficiency
syndrome, including a breakdown of all other
sources of funding for the care provided to
cover subacute care; and
(B) recommendations for appropriate
legislative changes.
(f) Each demonstration project shall provide for other
research to be carried out at the site of such demonstration
project including--
(1) clinical research on acquired immune deficiency
syndrome, concentrating on research on the neurological
manifestations resulting from infection with the
etiologic agent for such syndrome; and
(2) the study of the psychological and mental
health issues related to such syndrome.
(g)(1) To carry out this section, there are authorized to
be appropriated $10,000,000 for fiscal year 1989 and such sums
as are necessary for each of the fiscal years 1990 through
1992.
(2) Amounts appropriated pursuant to paragraph (1) shall
remain available until September 10, 1992.
(h) The Secretary shall enter into an agreement with the
Administrator of the Veterans' Administration to ensure that
appropriate provision will be made for the furnishing, through
demonstration projects, of services to eligible veterans, under
contract with the Veterans' Administration pursuant to section
620 of title 38, United States Code.
H2 deg.Part C--Other Health Services
H4 deg.SEC. 2431. [300DD-31] GRANTS FOR ANONYMOUS TESTING.
The Secretary may make grants to the States for the purpose
of providing opportunities for individuals--
(1) to undergo counseling and testing with respect
to the etiologic agent for acquired immune deficiency
syndrome without being required to provide any
information relating to the identity of the
individuals; and
(2) to undergo such counseling and testing through
the use of a pseudonym.
SEC. 2432. [300DD-32] REQUIREMENT OF PROVISION OF CERTAIN COUNSELING
SERVICES.
(a) Counseling Before Testing.--The Secretary may not make
a grant under section 2431 to a State unless the State agrees
that, before testing an individual pursuant to such section,
the State will provide to the individual appropriate counseling
with respect to acquired immune deficiency syndrome (based on
the most recent scientific data relating to such syndrome),
including--
(1) measures for the prevention of exposure to, and
the transmission of, the etiologic agent for such
syndrome;
(2) the accuracy and reliability of the results of
such testing;
(3) the significance of the results of such
testing, including the potential for developing
acquired immune deficiency syndrome; and
(4) encouraging individuals, as appropriate, to
undergo testing for such etiologic agent and providing
information on the benefits of such testing.
(b) Counseling of Individuals With Negative Test Results.--
The Secretary may not make a grant under section 2431 to a
State unless the State agrees that, if the results of testing
conducted pursuant to such section indicate that an individual
is not infected with the etiologic agent for acquired immune
deficiency syndrome, the State will review for the individual
the information provided pursuant to subsection (a) with
respect to such syndrome, including--
(1) the information described in paragraphs (1)
through (3) of such subsection; and
(2) the appropriateness of further counseling,
testing, and education of the individual with respect
to acquired immune deficiency syndrome.
(c) Counseling of Individuals With Positive Test Results.--
The Secretary may not make a grant under section 2431 to a
State unless the State agrees that, if the results of testing
conducted pursuant to such section indicate that an individual
is infected with the etiologic agent for acquired immune
deficiency syndrome, the State will provide to the individual
appropriate counseling with respect to such syndrome,
including--
(1) reviewing the information described in
paragraphs (1) through (3) of subsection (a);
(2) reviewing the appropriateness of further
counseling, testing, and education of the individual
with respect to acquired immune deficiency syndrome;
(3) the importance of not exposing others to the
etiologic agent for acquired immune deficiency
syndrome;
(4) the availability in the geographic area of any
appropriate services with respect to health care,
including mental health care and social and support
services;
(5) the benefits of locating and counseling any
individual by whom the infected individual may have
been exposed to the etiologic agent for acquired immune
deficiency syndrome and any individual whom the
infected individual may have exposed to such etiologic
agent; and
(6) the availability, if any, of the services of
public health authorities with respect to locating and
counseling any individual described in paragraph (5).
(d) Rule of Construction With Respect to Counseling Without
Testing.--Agreements entered into pursuant to subsections (a)
through (c) may not be construed to prohibit any grantee under
section 2431 from expending the grant for the purpose of
providing counseling services described in such subsections to
an individual who will not undergo testing described in such
section as a result of the grantee or the individual
determining that such testing of the individual is not
appropriate.
(e) Use of Funds.--
(1) The purpose of this subpart \1\ is to provide
for counseling and testing services to prevent and
reduce exposure to, and transmission of, the etiologic
agent for acquired immune deficiency syndrome.
---------------------------------------------------------------------------
\1\ Probably should be ``part''. See section 118(b)(1)(B) of Public
Law 102-321 (106 Stat. 348).
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(2) All individuals receiving counseling pursuant
to this subpart \1\ are to be counseled about the
harmful effects of promiscuous sexual activity and
intravenous substance abuse, and the benefits of
abstaining from such activities.
(3) None of the fund appropriated to carry out this
subpart \1\ may be used to provide counseling that is
designed to promote or encourage, directly, homosexual
or heterosexual sexual activity or intravenous drug
abuse.
(4) Paragraph (3) may not be construed to prohibit
a counselor who has already performed the counseling of
an individual required by paragraph (2), to provide
accurate information about means to reduce an
individual's risk of exposure to, or the transmission
of, the etiologic agent for acquired immune deficiency
syndrome, provided that any informational materials
used are not obscene. * deg.
H4 deg.SEC. 2433. [300DD-33] FUNDING.
For the purpose of grants under section 2431, there are
authorized to be appropriated $100,000,000 for each of the
fiscal years 1989 and 1990.ATTORNEY: PMG/FD (June 22,
1999) deg.
TITLE XXV--PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME \1\
H4 deg.SEC. 2500. [300EE] USE OF FUNDS.
(a) In General.--The purpose of this title is to provide
for the establishment of education and information programs to
prevent and reduce exposure to, and the transmission of, the
etiologic agent for acquired immune deficiency syndrome.
---------------------------------------------------------------------------
\1\ See footnote at beginning of title XXIII.
---------------------------------------------------------------------------
(b) Contents of Programs.--All programs of education and
information receiving funds under this title shall include
information about the harmful effects of promiscuous sexual
activity and intravenous substance abuse, and the benefits of
abstaining from such activities.
(c) Limitation.--None of the funds appropriated to carry
out this title may be used to provide education or information
designed to promote or encourage, directly, homosexual or
heterosexual sexual activity or intravenous substance abuse.
(d) Construction.--Subsection (c) may not be construed to
restrict the ability of an education program that includes the
information required in subsection (b) to provide accurate
information about various means to reduce an individual's risk
of exposure to, or the transmission of, the etiologic agent for
acquired immune deficiency syndrome, provided that any
informational materials used are not obscene.
Part A--Formula Grants to States
H4 deg.SEC. 2501. [300EE-11] ESTABLISHMENT OF PROGRAM.
(a) Allotments for States.--For the purpose described in
subsection (b), the Secretary shall for each of the fiscal
years 1989 through 1991 make an allotment for each State in an
amount determined in accordance with section 2507. The
Secretary shall make payments each such fiscal year to each
State from the allotment for the State if the Secretary
approves for the fiscal year involved an application submitted
by the State pursuant to section 2503.
(b) Purpose of Grants.--The Secretary may not make payments
under subsection (a) for a fiscal year unless the State
involved agrees to expend the payments only for the purpose of
carrying out, in accordance with section 2502, public
information activities with respect to acquired immune
deficiency syndrome.
H4 deg.SEC. 2502. [300EE-12] PROVISIONS WITH RESPECT TO
CARRYING OUT PURPOSE OF GRANTS.
A State may expend payments received under section
2501(a)--
(1) to develop, establish, and conduct public
information activities relating to the prevention and
diagnosis of acquired immune deficiency syndrome for
those populations or communities in the State in which
there are a significant number of individuals at risk
of infection with the etiologic agent for such
syndrome;
(2) to develop, establish, and conduct such public
information activities for the general public relating
to the prevention and diagnosis of such syndrome;
(3) to develop, establish, and conduct activities
to reduce risks relating to such syndrome, including
research into the prevention of such syndrome;
(4) to conduct demonstration projects for the
prevention of such syndrome;
(5) to provide technical assistance to public
entities, to nonprofit private entities concerned with
such syndrome, to schools, and to employers, for the
purpose of developing information programs relating to
such syndrome;
(6) with respect to education and training programs
for the prevention of such syndrome, to conduct such
programs for health professionals (including allied
health professionals), public safety workers (including
emergency response employees), teachers, school
administrators, and other appropriate education
personnel;
(7) to conduct appropriate programs for educating
school-aged children with respect to such syndrome,
after consulting with local school boards;
(8) to make available to physicians and dentists in
the State information with respect to acquired immune
deficiency syndrome, including measures for the
prevention of exposure to, and the transmission of, the
etiologic agent for such syndrome (which information is
updated not less than annually with the most recently
available scientific date \1\ relating to such
syndrome);
---------------------------------------------------------------------------
\1\ So in law. Probably should be ``data''.
---------------------------------------------------------------------------
(9) to carry out the initial implementation of
recommendations contained in the guidelines and the
model curriculum developed under section 253 of the
AIDS Amendments of 1988; and
(10) to make grants to public entities, and to
nonprofit private entities concerned with acquired
immune deficiency syndrome, for the purpose of the
development, establishment, and expansion of programs
for education directed toward individuals at increased
risk of infection with the etiologic agent for such
syndrome and activities to reduce the risks of exposure
to such etiologic agent, with preference to programs
directed toward populations in which there is
significant evidence of such infection.
H4 deg.SEC. 2503. [300EE-13] REQUIREMENT OF SUBMISSION OF
APPLICATION CONTAINING CERTAIN AGREEMENTS AND
ASSURANCES.
(a) In General.--The Secretary may not make payments under
section 2501(a) for a fiscal year unless--
(1) the State involved submits to the Secretary a
description of the purposes for which the State intends
to expend the payments for the fiscal year;
(2) the description identifies the populations,
areas, and localities in the State with a need for the
services for which amounts may be provided by the State
under this part;
(3) the description provides information relating
to the programs and activities to be supported and
services to be provided, including a description of the
manner in which such programs and activities will be
coordinated with any similar programs and activities of
public and private entities;
(4) the State submits to the Secretary an
application for the payments containing agreements in
accordance with this part;
(5) the agreements are made through certification
from the chief executive officer of the State;
(6) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary; and
(7) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this part.
(b) Opportunity for Public Comment.--The Secretary may not
make payments under section 2501(a) for a fiscal year unless
the State involved agrees that, in developing and carrying out
the description required in subsection (a), the State will
provide public notice with respect to the description
(including any revisions) and will facilitate comments from
interested persons.
H4 deg.SEC. 2504. [300EE-14] RESTRICTIONS ON USE OF GRANT.
(a) In General.--The Secretary may not make payments under
section 2501(a) for a fiscal year unless the State involved
agrees that the payments will not be expended--
(1) to provide inpatient services;
(2) to make cash payments to intended recipients of
services;
(3) to purchase or improve real property (other
than minor remodeling of existing improvements to real
property) or to purchase major medical equipment; or
(4) to satisfy any requirement for the expenditure
of non-Federal funds as a condition for the receipt of
Federal funds.
(b) Limitation on Administrative Expenses.--The Secretary
may not make payments under section 2501(a) for a fiscal year
unless the State involved agrees that the State will not expend
more than 5 percent of the payments for administrative expenses
with respect to carrying out the purpose described in section
2501(b).
H4 deg.SEC. 2505. [300EE-15] REQUIREMENT OF REPORTS AND
AUDITS BY STATES.
(a) Reports.--The Secretary may not make payments under
section 2501(a) for a fiscal year unless the State involved
agrees to prepare and submit to the Secretary an annual report
in such form and containing such information as the Secretary
determines to be necessary for--
(1) securing a record and a description of the
purposes for which payments received by the State
pursuant to such section were expended and of the
recipients of such payments;
(2) determining whether the payments were expended
in accordance with the needs within the State required
to be identified pursuant to section 2503(a)(2);
(3) determining whether the payments were expended
in accordance with the purpose described in section
2501(b); and
(4) determining the percentage of payments received
pursuant to such section that were expended by the
State for administrative expenses during the preceding
fiscal year.
(b) Audits.--
(1) The Secretary may not make payments under
section 2501(a) for a fiscal year unless the State
involved agrees to establish such fiscal control and
fund accounting procedures as may be necessary to
ensure the proper disbursal of, and accounting for,
amounts received by the State under such section.
(2) The Secretary may not make payments under
section 2501(a) for a fiscal year unless the State
involved agrees that--
(A) the State will provide for--
(i) a financial and compliance
audit of such payments; or
(ii) a single financial and
compliance audit of each entity
administering such payments;
(B) the audit will be performed biennially
and will cover expenditures in each fiscal
year; and
(C) the audit will be conducted in
accordance with standards established by the
Comptroller General of the United States for
the audit of governmental organizations,
programs, activities, and functions.
(3) The Secretary may not make payments under
section 2501(a) for a fiscal year unless the State
involved agrees that, not later than 30 days after the
completion of an audit under paragraph (2), the State
will provide a copy of the audit report to the State
legislature.
(4) For purposes of paragraph (2), the term
``financial and compliance audit'' means an audit to
determine whether the financial statements of an
audited entity present fairly the financial position,
and the results of financial operations, of the entity
in accordance with generally accepted accounting
principles, and whether the entity has complied with
laws and regulations that may have a material effect
upon the financial statements.
(c) Availability to Public.--The Secretary may not make
payments under section 2501(a) for a fiscal year unless the
State involved agrees to make copies of the reports and audits
described in this section available for public inspection.
(d) Evaluations by Comptroller General.--The Comptroller
General of the United States shall, from time to time, evaluate
the expenditures by States of payments received under section
2501(a) in order to ensure that expenditures are consistent
with the provisions of this part.
H4 deg.SEC. 2506. [300EE-16] ADDITIONAL REQUIRED AGREEMENTS.
(a) In General.--The Secretary may not, except as provided
in subsection (b), make payments under section 2501(a) for a
fiscal year unless the State involved agrees that--
(1) all programs conducted or supported by the
State with such payments will establish objectives for
the program and will determine the extent to which the
objectives are met;
(2) information provided under this part will be
scientifically accurate and factually correct;
(3) in carrying out section 2501(b), the State will
give priority to programs described in section 2502(10)
for individuals described in such section;
(4) with respect to a State in which there is a
substantial number of individuals who are intravenous
substance abusers, the State will place priority on
activities under this part directed at such substance
abusers;
(5) with respect to a State in which there is a
significant incidence of reported cases of acquired
immune deficiency syndrome, the State will--
(A) for the purpose described in subsection
(b) of section 2501, expend not less than 50
percent of payments received under subsection
(a) of such section for a fiscal year--
(i) to make grants to public
entities, to migrant health centers (as
defined in section 329(a)), to
community health centers (as defined in
section 330(a)) \1\, and to nonprofit
private entities concerned with
acquired immune deficiency syndrome; or
---------------------------------------------------------------------------
\1\ See footnote for section 217(a).
---------------------------------------------------------------------------
(ii) to enter into contracts with
public and private entities; and
(B) of the amounts reserved for a fiscal
year by the State for expenditures required in
subparagraph (A), expend not less than 50
percent to carry out section 2502(10) through
grants to nonprofit private entities, including
minority entities, concerned with acquired
immune deficiency syndrome located in and
representative of communities and
subpopulations reflecting the local incidence
of such syndrome;
(6) with respect to programs carried out pursuant
to section 2502(10), the State will ensure that any
applicant for a grant under such section agrees--
(A) that any educational or informational
materials developed with a grant pursuant to
such section will contain material, and be
presented in a manner, that is specifically
directed toward the group for which such
materials are intended;
(B) to provide a description of the manner
in which the applicant has planned the program
in consultation with, and of the manner in
which such applicant will consult during the
conduct of the program with--
(i) appropriate local officials and
community groups for the area to be
served by the program;
(ii) organizations comprised of,
and representing, the specific
population to which the education or
prevention effort is to be directed;
and
(iii) individuals having expertise
in health education and in the needs of
the population to be served;
(C) to provide information demonstrating
that the applicant has continuing
relationships, or will establish continuing
relationships, with a portion of the population
in the service area that is at risk of
infection with the etiologic agent for acquired
immune deficiency syndrome and with public and
private entities in such area that provide
health or other support services to individuals
with such infection;
(D) to provide a description of--
(i) the objectives established by
the applicant for the conduct of the
program; and
(ii) the methods the applicant will
use to evaluate the activities
conducted under the program to
determine if such objectives are met;
and
(E) such other information as the Secretary
may prescribe;
(7) with respect to programs carried out pursuant
to section 2502(10), the State will give preference to
any applicant for a grant pursuant to such section that
is located in, has a history of service in, and will
serve under the program, any geographic area in which--
(A) there is a significant incidence of
acquired immune deficiency syndrome;
(B) there has been a significant increase
in the incidence of such syndrome; or
(C) there is a significant risk of becoming
infected with the etiologic agent for such
syndrome;
(8) the State will establish reasonable criteria to
evaluate the effective performance of entities that
receive funds from payments made to the State under
section 2501(a) and will establish procedures for
procedural and substantive independent State review of
the failure by the State to provide funds for any such
entity;
(9) the State will permit and cooperate with
Federal investigations undertaken in accordance with
section 2508(e);
(10) the State will maintain State expenditures for
services provided pursuant to section 2501 at a level
equal to not less than the average level of such
expenditures maintained by the State for the 2-year
period preceding the fiscal year for which the State is
applying to receive payments.
(b) Definition.--For purposes of subsection (a)(5), the
term ``significant percentage'' means at least a percentage of
1 percent of the number of reported cases of acquired immune
deficiency syndrome in the United States.
H4 deg.SEC. 2507. [300EE-17] DETERMINATION OF AMOUNT OF
ALLOTMENTS FOR STATES.
(a) Minimum Allotment.--Subject to the extent of amounts
made available in appropriation Acts, the allotment for a State
under section 2501(a) for a fiscal year shall be the greater
of--
(1) the applicable amount specified in subsection
(b); or
(2) the amount determined in accordance with
subsection (c).
(b) Determination of Minimum Allotment.--
(1) If the total amount appropriated under section
2514(a) for a fiscal year exceeds $100,000,000, the
amount referred to in subsection (a)(1) shall be
$300,000 for the fiscal year.
(2) If the total amount appropriated under section
2514(a) for a fiscal year equals or exceeds
$50,000,000, but is less than $100,000,000, the amount
referred to in subsection (a)(1) shall be $200,000 for
the fiscal year.
(3) If the total amount appropriated under section
2514(a) for a fiscal year is less than $50,000,000, the
amount referred to in subsection (a)(1) shall be
$100,000 for the fiscal year.
(c) Determination Under Formula.--
(1) The amount referred to in subsection (a)(2) is
the sum of--
(A) the amount determined under paragraph
(2); and
(B) the amount determined under paragraph
(3).
(2) The amount referred to in paragraph (1)(A) is
the product of--
(A) an amount equal to 50 percent of the
amounts appropriated pursuant to section
2514(a); and
(B) a percentage equal to the quotient of--
(i) the population of the State
involved; divided by
(ii) the population of the United
States.
(3) The amount referred to in paragraph (1)(B) is
the product of--
(A) an amount equal to 50 percent of the
amounts appropriated pursuant to section
2514(a); and
(B) a percentage equal to the quotient of--
(i) the number of additional cases
of acquired immune deficiency syndrome
reported to and confirmed by the
Secretary for the State involved for
the most recent fiscal year for which
such data is available; divided by
(ii) the number of additional cases
of such syndrome reported to and
confirmed by the Secretary for the
United States for such fiscal year.
(d) Disposition of Certain Funds Appropriated for
Allotments.--
(1) Amounts described in paragraph (2) shall be
allotted by the Secretary to States receiving payments
under section 2501(a) for the fiscal year (other than
any State referred to in paragraph (2)(C)). Such
amounts shall be allotted according to a formula
established by the Secretary. The formula shall be
equivalent to the formula described in this section
under which the allotment under section 2501(a) for the
State for the fiscal year involved was determined.
(2) The amounts referred to in paragraph (1) are
any amounts that are not paid to States under section
2501(a) as a result of--
(A) the failure of any State to submit an
application under section 2503;
(B) the failure, in the determination of
the Secretary, of any State to prepare within a
reasonable period of time such application in
compliance with such section; or
(C) any State informing the Secretary that
the State does not intend to expend the full
amount of the allotment made to the State.
H4 deg.SEC. 2508. [300EE-18] FAILURE TO COMPLY WITH
AGREEMENTS.
(a) Repayment of Payments.--
(1) The Secretary may, subject to subsection (c),
require a State to repay any payments received by the
State under section 2501(a) that the Secretary
determines were not expended by the State in accordance
with the agreements required to be contained in the
application submitted by the State pursuant to section
2503.
(2) If a State fails to make a repayment required
in paragraph (1), the Secretary may offset the amount
of the repayment against the amount of any payment due
to be paid to the State under section 2501(a).
(b) Withholding of Payments.--
(1) The Secretary may, subject to subsection (c),
withhold payments due under section 2501(a) if the
Secretary determines that the State involved is not
expending amounts received under such section in
accordance with the agreements required to be contained
in the application submitted by the State pursuant to
section 2503.
(2) The Secretary shall cease withholding payments
from a State under paragraph (1) if the Secretary
determines that there are reasonable assurances that
the State will expend amounts received under section
2501(a) in accordance with the agreements referred to
in such paragraph.
(3) The Secretary may not withhold funds under
paragraph (1) from a State for a minor failure to
comply with the agreements referred to in such
paragraph.
(c) Opportunity for Hearing.--Before requiring repayment of
payments under subsection (a)(1), or withholding payments under
subsection (b)(1), the Secretary shall provide to the State an
opportunity for a hearing conducted within the State.
(d) Prompt Response to Serious Allegations.--The Secretary
shall promptly respond to any complaint of a substantial or
serious nature that a State has failed to expend amounts
received under section 2501(a) in accordance with the
agreements required to be contained in the application
submitted by the State pursuant to section 2503.
(e) Investigations.--
(1) The Secretary shall conduct in several States
in each fiscal year investigations of the expenditure
of payments received by the States under section
2501(a) in order to evaluate compliance with the
agreements required to be contained in the applications
submitted to the Secretary pursuant to section 2503.
(2) The Comptroller General of the United States
may conduct investigations of the expenditure of funds
received under section 2501(a) by a State in order to
ensure compliance with the agreements referred to in
paragraph (1).
(3) Each State, and each entity receiving funds
from payments made to a State under section 2501(a),
shall make appropriate books, documents, papers, and
records available to the Secretary and the Comptroller
General of the United States, or any of their duly
authorized representatives, for examination, copying,
or mechanical reproduction on or off the premises of
the appropriate entity upon a reasonable request
therefor.
(4)(A) In conducting any investigation in a State,
the Secretary and the Comptroller General of the United
States may not make a request for any information not
readily available to the State, or to an entity
receiving funds from payments made to the State under
section 2501(a), or make an unreasonable request for
information to be compiled, collected, or transmitted
in any form not readily available.
(B) Subparagraph (A) shall not apply to the
collection, compilation, or transmittal of data in the
course of a judicial proceeding.
H4 deg.SEC. 2509. [300EE-19] PROHIBITION AGAINST CERTAIN
FALSE STATEMENTS.
(a) In General.--
(1) A person may not knowingly make or cause to be
made any false statement or representation of a
material fact in connection with the furnishing of
items or services for which amounts may be paid by a
State from payments received by the State under section
2501(a).
(2) A person with knowledge of the occurrence of
any event affecting the right of the person to receive
any amounts from payments made to the State under
section 2501(a) may not conceal or fail to disclose any
such event with the intent of fraudulently securing
such amounts.
(b) Criminal Penalty for Violation of Prohibition.--Any
person who violates a prohibition established in subsection (a)
may for each violation be fined in accordance with title 18,
United States Code, or imprisoned for not more than 5 years, or
both.
H4 deg.SEC. 2510. [300EE-20] TECHNICAL ASSISTANCE AND
PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
LIEU OF GRANT FUNDS.
(a) Technical Assistance.--The Secretary may provide
training and technical assistance to States with respect to the
planning, development, and operation of any program or service
carried out pursuant to this part. The Secretary may provide
such technical assistance directly or through grants or
contracts.
(b) Provision by Secretary of Supplies and Services in Lieu
of Grant Funds.--
(1) Upon the request of a State receiving payments
under this part, the Secretary may, subject to
paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the State in
carrying out such part and, for such purpose, may
detail to the State any officer or employee of the
Department of Health and Human Services.
(2) With respect to a request described in
paragraph (1), the Secretary shall reduce the amount of
payments under section 2501(a) to the State by an
amount equal to the costs of detailing personnel and
the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary
shall, for the payment of expenses incurred in
complying with such request, expend the amounts
withheld.
H4 deg.SEC. 2511. [300EE-21] EVALUATIONS.
The Secretary shall, directly or through grants or
contracts, evaluate the services provided and activities
carried out with payments to States under this part.
H4 deg.SEC. 2512. [300EE-22] REPORT BY SECRETARY.
The Secretary shall annually prepare a report on the
activities of the States carried out pursuant to this part.
Such report may include any recommendations of the Secretary
for appropriate administrative and legislative initiatives. The
report shall be submitted to the Congress through inclusion in
the comprehensive report required in section 2301(a).
H4 deg.SEC. 2513. [300EE-23] DEFINITION.
For purposes of this part, the term ``infection with the
etiologic agent for acquired immune deficiency syndrome''
includes any condition arising from such etiologic agent.
H4 deg.SEC. 2514. [300EE-24] FUNDING.
(a) Authorization of Appropriations.--For the purpose of
making allotments under section 2501(a), there are authorized
to be appropriated $165,000,000 for fiscal year 1989 and such
sums as may be necessary for each of the fiscal years 1990 and
1991.
(b) Availability to States.--Any amounts paid to a State
under section 2501(a) shall remain available to the State until
the expiration of the 1-year period beginning on the date on
which the State receives such amounts.
H2 deg.Part B--National Information Programs
H4 deg.SEC. 2521. [300EE-31] AVAILABILITY OF INFORMATION TO
GENERAL PUBLIC.
(a) Comprehensive Information Plan.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall annually prepare a comprehensive plan,
including a budget, for a National Acquired Immune Deficiency
Syndrome Information Program. The plan shall contain provisions
to implement the provisions of this title. The Director shall
submit such plan to the Secretary. The authority established in
this subsection may not be construed to be the exclusive
authority for the Director to carry out information activities
with respect to acquired immune deficiency syndrome.
(b) Clearinghouse.--
(1) The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may
establish a clearinghouse to make information
concerning acquired immune deficiency syndrome
available to Federal agencies, States, public and
private entities, and the general public.
(2) The clearinghouse may conduct or support
programs--
(A) to develop and obtain educational
materials, model curricula, and methods
directed toward reducing the transmission of
the etiologic agent for acquired immune
deficiency syndrome;
(B) to provide instruction and support for
individuals who provide instruction in methods
and techniques of education relating to the
prevention of acquired immune deficiency
syndrome and instruction in the use of the
materials and curricula described in
subparagraph (A); and
(C) to conduct, or to provide for the
conduct of, the materials, curricula, and
methods described in paragraph (1) and the
efficacy of such materials, curricula, and
methods in preventing infection with the the
\1\ etiologic agent for acquired immune
deficiency syndrome.
---------------------------------------------------------------------------
\1\ So in law. The word ``the'' appears twice.
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(c) Toll-Free Telephone Communications.--The Secretary
shall provide for the establishment and maintenance of toll-
free telephone communications to provide information to, and
respond to queries from, the public concerning acquired immune
deficiency syndrome. Such communications shall be available on
a 24-hour basis.
H4 deg.SEC. 2522. [300EE-32] PUBLIC INFORMATION CAMPAIGNS.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may make
grants to public entities, and to nonprofit private entities
concerned with acquired immune deficiency syndrome, and shall
enter into contracts with public and private entities, for the
development and delivery of public service announcements and
paid advertising messages that warn individuals about
activities which place them at risk of infection with the
etiologic agent for such syndrome.
(b) Requirement of Application.--The Secretary may not
provide financial assistance under subsection (a) unless--
(1) an application for such assistance is submitted
to the Secretary;
(2) with respect to carrying out the purpose for
which the assistance is to be provided, the application
provides assurances of compliance satisfactory to the
Secretary; and
(3) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this section.
H4 deg.SEC. 2523. [300EE-33] PROVISION OF INFORMATION TO
UNDERSERVED POPULATIONS.
(a) In General.--The Secretary may make grants to public
entities, to migrant health centers (as defined in section
329(a) \2\), to community health centers (as defined in section
330(a)) \2\, and to nonprofit private entities concerned with
acquired immune deficiency syndrome, for the purpose of
assisting grantees in providing services to populations of
individuals that are underserved with respect to programs
providing information on the prevention of exposure to, and the
transmission of, the etiologic agent for acquired immune
deficiency syndrome.
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\2\ See footnote for section 217(a).
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(b) Preferences in Making Grants.--In making grants under
subsection (a), the Secretary shall give preference to any
applicant for such a grant that has the ability to disseminate
rapidly the information described in subsection (a) (including
any national organization with such ability).
H4 deg.SEC. 2524. [300EE-34] AUTHORIZATION OF
APPROPRIATIONS.
(a) In General.--For the purpose of carrying out sections
2521 through 2523, there are authorized to be appropriated
$105,000,000 for fiscal year 1989 and such sums as may be
necessary for each of the fiscal years 1990 and 1991.
(b) Allocations.--
(1) Of the amounts appropriated pursuant to
subsection (a), the Secretary shall make available
$45,000,000 to carry out section 2522 and $30,000,000
to carry out this part through financial assistance to
minority entities for the provision of services to
minority populations.
(2) After consultation with the Director of the
Office of Minority Health and with the Indian Health
Service, the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall,
not later than 90 days after the date of the enactment
of the AIDS Amendments of 1988, \1\ publish guidelines
to provide procedures for applications for funding
pursuant to paragraph (1) and for public comment.
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\1\ Enacted on November 4, 1988.ATTORNEY: PMG/FD (June 24,
1999) deg.
TITLE XXVI--HIV HEALTH CARE SERVICES PROGRAM 1, 2
Part A--Emergency Relief for Areas With Substantial Need for Services
\3\
Subpart I--General Grant Provisions
SEC. 2601. [300FF-11] ESTABLISHMENT OF PROGRAM OF GRANTS.
(a) Eligible Areas.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall, subject to subsections (b) through (c),
make grants in accordance with section 2603 for the purpose of
assisting in the provision of the services specified in section
2604 in any metropolitan area for which there has been reported
to and confirmed by the Director of the Centers for Disease
Control and Prevention a cumulative total of more than 2,000
cases of AIDS during the most recent period of 5 calendar years
for which such data are available.
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\1\ This title was added by Public Law 101-381. Section 2 of that
Public Law provides as follows: ``It is the purpose of this Act to
provide emergency assistance to localities that are disproportionately
affected by the Human Immunodeficiency Virus epidemic and to make
financial assistance available to States and other public or private
nonprofit entities to provide for the development, organization,
coordination and operation of more effective and cost efficient systems
for the delivery of essential services to individuals and families with
HIV disease.''.
\2\ Section 502 of Public Law 106-345 (114 Stat. 1353) relates to
the development of reliable and affordable tests for HIV disease that
can rapidly be administered and whose results can rapidly be obtained.
\3\ With respect to information for determining formula grants
under parts A and B, section 501(a) of Public Law 106-345 (114 Stat.
1352) provides for a study of State surveillance systems regarding
cases of infection with the human immunodeficiency virus. Section
501(d)(1) of such Law requires that a report of the findings of the
study be submitted not later than 3 years after the date of the
enactment of the Law, which was enacted October 20, 2000.
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(b) Continued Status as Eligible Area.--Notwithstanding any
other provision of this section, a metropolitan area that is an
eligible area for a fiscal year continues to be an eligible
area until the metropolitan area fails, for three consecutive
fiscal years--
(1) to meet the requirements of subsection (a); and
(2) to have a cumulative total of 3,000 or more
living cases of AIDS (reported to and confirmed by the
Director of the Centers for Disease Control and
Prevention) as of December 31 of the most recent
calendar year for which such data is available.
(c) Boundaries.--For purposes of determining eligibility
under this subpart--
(1) with respect to a metropolitan area that
received funding under this subpart in fiscal year
2006, the boundaries of such metropolitan area shall be
the boundaries that were in effect for such area for
fiscal year 1994; or
(2) with respect to a metropolitan area that
becomes eligible to receive funding under this subpart
in any fiscal year after fiscal year 2006, the
boundaries of such metropolitan area shall be the
boundaries that are in effect for such area when such
area initially receives funding under this subpart.
SEC. 2602. [300FF-12] ADMINISTRATION AND PLANNING COUNCIL.
(a) Administration.--
(1) In general.--Assistance made available under
grants awarded under this subpart shall be directed to
the chief elected official of the city or urban county
that administers the public health agency that provides
outpatient and ambulatory services to the greatest
number of individuals with AIDS, as reported to and
confirmed by the Centers for Disease Control and
Prevention, in the eligible area that is awarded such a
grant.
(2) Requirements.--
(A) In general.--To receive assistance
under section 2601(a), the chief elected
official of the eligible area involved shall--
(i) establish, through
intergovernmental agreements with the
chief elected officials of the
political subdivisions described in
subparagraph (B), an administrative
mechanism to allocate funds and
services based on--
(I) the number of AIDS
cases in such subdivisions;
(II) the severity of need
for outpatient and ambulatory
care services in such
subdivisions; and
(III) the health and
support services personnel
needs of such subdivisions; and
(ii) establish an HIV health
services planning council in accordance
with subsection (b).
(B) Local political subdivision.--The
political subdivisions referred to in
subparagraph (A) are those political
subdivisions in the eligible area--
(i) that provide HIV-related health
services; and
(ii) for which the number of cases
reported for purposes of section
2601(a) constitutes not less than 10
percent of the number of such cases
reported for the eligible area.
(b) HIV Health Services Planning Council.--
(1) Establishment.--To be eligible for assistance
under this subpart, the chief elected official
described in subsection (a)(1) shall establish or
designate an HIV health services planning council that
shall reflect in its composition the demographics of
the population of individuals with HIV/AIDS in the
eligible area involved, with particular consideration
given to disproportionately affected and historically
underserved groups and subpopulations. Nominations for
membership on the council shall be identified through
an open process and candidates shall be selected based
on locally delineated and publicized criteria. Such
criteria shall include a conflict-of-interest standard
that is in accordance with paragraph (5).
(2) Representation.--The HIV health services
planning council shall include representatives of--
(A) health care providers, including
federally qualified health centers;
(B) community-based organizations serving
affected populations and AIDS service
organizations;
(C) social service providers, including
providers of housing and homeless services;
(D) mental health and substance abuse
providers;
(E) local public health agencies;
(F) hospital planning agencies or health
care planning agencies;
(G) affected communities, including people
with HIV/AIDS, members of a Federally
recognized Indian tribe as represented in the
population, individuals co-infected with
hepatitis B or C and historically underserved
groups and subpopulations;
(H) nonelected community leaders;
(I) State government (including the State
medicaid agency and the agency administering
the program under part B);
(J) grantees under subpart II of part C;
(K) grantees under section 2671, or, if
none are operating in the area, representatives
of organizations with a history of serving
children, youth, women, and families living
with HIV and operating in the area;
(L) grantees under other Federal HIV
programs, including but not limited to
providers of HIV prevention services; and
(M) representatives of individuals who
formerly were Federal, State, or local
prisoners, were released from the custody of
the penal system during the preceding 3 years,
and had HIV/AIDS as of the date on which the
individuals were so released.
(3) Method of providing for council.--
(A) In general.--In providing for a council
for purposes of paragraph (1), a chief elected
official receiving a grant under section
2601(a) may establish the council directly or
designate an existing entity to serve as the
council, subject to subparagraph (B).
(B) Consideration regarding designation of
council.--In making a determination of whether
to establish or designate a council under
subparagraph (A), a chief elected official
receiving a grant under section 2601(a) shall
give priority to the designation of an existing
entity that has demonstrated experience in
planning for the HIV health care service needs
within the eligible area and in the
implementation of such plans in addressing
those needs. Any existing entity so designated
shall be expanded to include a broad
representation of the full range of entities
that provide such services within the
geographic area to be served.
(4) Duties.--The planning council established or
designated under paragraph (1) shall--
(A) determine the size and demographics of
the population of individuals with HIV/AIDS, as
well as the size and demographics of the
estimated population of individuals with HIV/
AIDS who are unaware of their HIV status;
(B) determine the needs of such population,
with particular attention to--
(i) individuals with HIV/AIDS who
know their HIV status and are not
receiving HIV-related services;
(ii) disparities in access and
services among affected subpopulations
and historically underserved
communities; and
(iii) individuals with HIV/AIDS who
do not know their HIV status;
(C) establish priorities for the allocation
of funds within the eligible area, including
how best to meet each such priority and
additional factors that a grantee should
consider in allocating funds under a grant
based on the--
(i) size and demographics of the
population of individuals with HIV/AIDS
(as determined under subparagraph (A))
and the needs of such population (as
determined under subparagraph (B));
(ii) demonstrated (or probable)
cost effectiveness and outcome
effectiveness of proposed strategies
and interventions, to the extent that
data are reasonably available;
(iii) priorities of the communities
with HIV/AIDS for whom the services are
intended;
(iv) coordination in the provision
of services to such individuals with
programs for HIV prevention and for the
prevention and treatment of substance
abuse, including programs that provide
comprehensive treatment for such abuse;
(v) availability of other
governmental and non-governmental
resources, including the State medicaid
plan under title XIX of the Social
Security Act and the State Children's
Health Insurance Program under title
XXI of such Act to cover health care
costs of eligible individuals and
families with HIV/AIDS; and
(vi) capacity development needs
resulting from disparities in the
availability of HIV-related services in
historically underserved communities;
(D) develop a comprehensive plan for the
organization and delivery of health and support
services described in section 2604 that--
(i) includes a strategy for
identifying individuals who know their
HIV status and are not receiving such
services and for informing the
individuals of and enabling the
individuals to utilize the services,
giving particular attention to
eliminating disparities in access and
services among affected subpopulations
and historically underserved
communities, and including discrete
goals, a timetable, and an appropriate
allocation of funds;
(ii) includes a strategy to
coordinate the provision of such
services with programs for HIV
prevention (including outreach and
early intervention) and for the
prevention and treatment of substance
abuse (including programs that provide
comprehensive treatment services for
such abuse);
(iii) is compatible with any State
or local plan for the provision of
services to individuals with HIV/AIDS;
and
(iv) includes a strategy,
coordinated as appropriate with other
community strategies and efforts,
including discrete goals, a timetable,
and appropriate funding, for
identifying individuals with HIV/AIDS
who do not know their HIV status,
making such individuals aware of such
status, and enabling such individuals
to use the health and support services
described in section 2604, with
particular attention to reducing
barriers to routine testing and
disparities in access and services
among affected subpopulations and
historically underserved communities;
(E) assess the efficiency of the
administrative mechanism in rapidly allocating
funds to the areas of greatest need within the
eligible area, and at the discretion of the
planning council, assess the effectiveness,
either directly or through contractual
arrangements, of the services offered in
meeting the identified needs;
(F) participate in the development of the
statewide coordinated statement of need
initiated by the State public health agency
responsible for administering grants under part
B;
(G) establish methods for obtaining input
on community needs and priorities which may
include public meetings (in accordance with
paragraph (7)), conducting focus groups, and
convening ad-hoc panels; and
(H) coordinate with Federal grantees that
provide HIV-related services within the
eligible area.
(5) Conflicts of interest.--
(A) In general.--The planning council under
paragraph (1) may not be directly involved in
the administration of a grant under section
2601(a). With respect to compliance with the
preceding sentence, the planning council may
not designate (or otherwise be involved in the
selection of) particular entities as recipients
of any of the amounts provided in the grant.
(B) Required agreements.--An individual may
serve on the planning council under paragraph
(1) only if the individual agrees that if the
individual has a financial interest in an
entity, if the individual is an employee of a
public or private entity, or if the individual
is a member of a public or private
organization, and such entity or organization
is seeking amounts from a grant under section
2601(a), the individual will not, with respect
to the purpose for which the entity seeks such
amounts, participate (directly or in an
advisory capacity) in the process of selecting
entities to receive such amounts for such
purpose.
(C) Composition of council.--The following
applies regarding the membership of a planning
council under paragraph (1):
(i) Not less than 33 percent of the
council shall be individuals who are
receiving HIV-related services pursuant
to a grant under section 2601(a), are
not officers, employees, or consultants
to any entity that receives amounts
from such a grant, and do not represent
any such entity, and reflect the
demographics of the population of
individuals with HIV/AIDS as determined
under paragraph (4)(A). For purposes of
the preceding sentence, an individual
shall be considered to be receiving
such services if the individual is a
parent of, or a caregiver for, a minor
child who is receiving such services.
(ii) With respect to membership on
the planning council, clause (i) may
not be construed as having any effect
on entities that receive funds from
grants under any of parts B through F
but do not receive funds from grants
under section 2601(a), on officers or
employees of such entities, or on
individuals who represent such
entities.
(6) Grievance procedures.--A planning council under
paragraph (1) shall develop procedures for addressing
grievances with respect to funding under this subpart,
including procedures for submitting grievances that
cannot be resolved to binding arbitration. Such
procedures shall be described in the by-laws of the
planning council and be consistent with the
requirements of subsection (c).
(7) Public deliberations.--With respect to a
planning council under paragraph (1), the following
applies:
(A) The council may not be chaired solely
by an employee of the grantee under section
2601(a).
(B) In accordance with criteria established
by the Secretary:
(i) The meetings of the council
shall be open to the public and shall
be held only after adequate notice to
the public.
(ii) The records, reports,
transcripts, minutes, agenda, or other
documents which were made available to
or prepared for or by the council shall
be available for public inspection and
copying at a single location.
(iii) Detailed minutes of each
meeting of the council shall be kept.
The accuracy of all minutes shall be
certified to by the chair of the
council.
(iv) This subparagraph does not
apply to any disclosure of information
of a personal nature that would
constitute a clearly unwarranted
invasion of personal privacy, including
any disclosure of medical information
or personnel matters.
(c) \1\ Grievance Procedures.--
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\1\ Subsection (c) was added by an amendment to subsection (b).
Section 3(b)(1)(F) of Public Law 104-146 (110 Stat. 1348) provided that
subsection (b) of section 2602 is amended ``by adding at the end
thereof the following:'', and then added paragraphs (5) and (6) and
subsection (c).
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(1) Federal responsibility.--
(A) Models.--The Secretary shall, through a
process that includes consultations with
grantees under this subpart and public and
private experts in grievance procedures,
arbitration, and mediation, develop model
grievance procedures that may be implemented by
the planning council under subsection (b)(1)
and grantees under this subpart. Such model
procedures shall describe the elements that
must be addressed in establishing local
grievance procedures and provide grantees with
flexibility in the design of such local
procedures.
(B) Review.--The Secretary shall review
grievance procedures established by the
planning council and grantees under this
subpart to determine if such procedures are
adequate. In making such a determination, the
Secretary shall assess whether such procedures
permit legitimate grievances to be filed,
evaluated, and resolved at the local level.
(2) Grantees.--To be eligible to receive funds
under this subpart, a grantee shall develop grievance
procedures that are determined by the Secretary to be
consistent with the model procedures developed under
paragraph (1)(A). Such procedures shall include a
process for submitting grievances to binding
arbitration.
(d) Process for Establishing Allocation Priorities.--
Promptly after the date of the submission of the report
required in section 501(b) of the Ryan White CARE Act
Amendments of 2000 \1\ (relating to the relationship between
epidemiological measures and health care for certain
individuals with HIV/AIDS), the Secretary, in consultation with
planning councils and entities that receive amounts from grants
under section 2601(a) or 2611, shall develop epidemiologic
measures--
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\1\ Public Law 106-345 (114 Stat. 1352). Section 501(d)(2) of such
Law requires that the report be submitted not later than 2 years after
the date of the enactment of the Law, which was enacted October 20,
2000.
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(1) for establishing the number of individuals
living with HIV/AIDS who are not receiving HIV-related
health services; and
(2) for carrying out the duties under subsection
(b)(4) and section 2617(b).
(e) Training Guidance and Materials.--The Secretary shall
provide to each chief elected official receiving a grant under
section 2601(a) guidelines and materials for training members
of the planning council under paragraph (1) regarding the
duties of the council.
SEC. 2603. [300FF-13] TYPE AND DISTRIBUTION OF GRANTS.
(a) Grants Based on Relative Need of Area.--
(1) In general.--In carrying out section 2601(a),
the Secretary shall make a grant for each eligible area
for which an application under section 2605(a) has been
approved. Each such grant shall be made in an amount
determined in accordance with paragraph (3).
(2) Expedited distribution.--Not later than 60 days
after an appropriation becomes available to carry out
this subpart for a fiscal year, the Secretary shall,
except in the case of waivers granted under section
2605(c), disburse 66\2/3\ percent of the amount made
available under section 2610(b) for carrying out this
subpart for such fiscal year through grants to eligible
areas under section 2601(a), in accordance with
paragraphs (3) and (4).
(3) Amount of grant.--
(A) In general.--Subject to the extent of
amounts made available in appropriations Acts,
a grant made for purposes of this paragraph to
an eligible area shall be made in an amount
equal to the product of--
(i) an amount equal to the amount
available for distribution under
paragraph (2) for the fiscal year
involved; and
(ii) the percentage constituted by
the ratio of the distribution factor
for the eligible area to the sum of the
respective distribution factors for all
eligible areas;
which product shall then, as applicable, be
increased under paragraph (4).
(B) Distribution factor.--For purposes of
subparagraph (A)(ii), the term ``distribution
factor'' means an amount equal to the estimated
number of living cases of AIDS \1\ in the
eligible area involved, as determined under
subparagraph (C).
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\1\ Section 102(b)(1) of Public Law 109-415 provides as follows:
(1) in subparagraph (B), by striking ``estimated living cases
of acquired immune deficiency syndrome'' and inserting ``living
cases of HIV/AIDS (reported to and confirmed by the Director of
---------------------------------------------------------------------------
the Centers for Disease Control and Prevention)''; and
Such amendment could not be executed because the words ``number
of'' probably should appear before ``living cases'' in the matter
purported to be struck.
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(C) Living cases of hiv/aids.--
(i) Requirement of names-based
reporting.--Except as provided in
clause (ii), the number determined
under this subparagraph for an eligible
area for a fiscal year for purposes of
subparagraph (B) is the number of
living names-based cases of HIV/AIDS
that, as of December 31 of the most
recent calendar year for which such
data is available, have been reported
to and confirmed by the Director of the
Centers for Disease Control and
Prevention.
(ii) Transition period; exemption
regarding non-aids cases.--For each of
the fiscal years 2007 through 2012, an
eligible area is, subject to clauses
(iii) through (v), exempt from the
requirement under clause (i) that
living names-based non-AIDS cases of
HIV be reported unless--
(I) a system was in
operation as of December 31,
2005, that provides
sufficiently accurate and
reliable names-based reporting
of such cases throughout the
State in which the area is
located, subject to clause
(viii); or
(II) no later than the
beginning of fiscal year 2008
or a subsequent fiscal year
through fiscal year 2012, the
Secretary, in consultation with
the chief executive of the
State in which the area is
located, determines that a
system has become operational
in the State that provides
sufficiently accurate and
reliable names-based reporting
of such cases throughout the
State.
(iii) Requirements for exemption
for fiscal year 2007.--For fiscal year
2007, an exemption under clause (ii)
for an eligible area applies only if,
by October 1, 2006--
(I)(aa) the State in which
the area is located had
submitted to the Secretary a
plan for making the transition
to sufficiently accurate and
reliable names-based reporting
of living non-AIDS cases of
HIV; or
(bb) all statutory changes
necessary to provide for
sufficiently accurate and
reliable reporting of such
cases had been made; and
(II) the State had agreed
that, by April 1, 2008, the
State will begin accurate and
reliable names-based reporting
of such cases, except that such
agreement is not required to
provide that, as of such date,
the system for such reporting
be fully sufficient with
respect to accuracy and
reliability throughout the
area.
(iv) Requirement for exemption as
of fiscal year 2008.--For each of the
fiscal years 2008 through 2012, an
exemption under clause (ii) for an
eligible area applies only if, as of
April 1, 2008, the State in which the
area is located is substantially in
compliance with the agreement under
clause (iii)(II).
(v) Progress toward names-based
reporting.--For fiscal year 2009 or a
subsequent fiscal year, the Secretary
may terminate an exemption under clause
(ii) for an eligible area if the State
in which the area is located submitted
a plan under clause (iii)(I)(aa) and
the Secretary determines that the State
is not substantially following the
plan.
(vi) Counting of cases in areas
with exemptions.--
(I) In general.--With
respect to an eligible area
that is under a reporting
system for living non-AIDS
cases of HIV that is not names-
based (referred to in this
subparagraph as ``code-based
reporting''), the Secretary
shall, for purposes of this
subparagraph, modify the number
of such cases reported for the
eligible area in order to
adjust for duplicative
reporting in and among systems
that use code-based reporting.
(II) Adjustment rate.--The
adjustment rate under subclause
(I) for an eligible area shall
be a reduction of 5 percent for
fiscal years before fiscal year
2012 (and 6 percent for fiscal
year 2012) in the number of
living non-AIDS cases of HIV
reported for the area.
(III) Increased adjustment
for certain areas previously
using code-based reporting.--
For purposes of this
subparagraph for each of fiscal
years 2010 through 2012, the
Secretary shall deem the
applicable number of living
cases of HIV/AIDS in an area
that were reported to and
confirmed by the Centers for
Disease Control and Prevention
to be 3 percent higher than the
actual number if--
(aa) for fiscal
year 2007, such area
was a transitional
area;
(bb) fiscal year
2007 was the first year
in which the count of
living non-AIDS cases
of HIV in such area,
for purposes of this
section, was based on a
names-based reporting
system; and
(cc) the amount of
funding that such area
received under this
part for fiscal year
2007 was less than 70
percent of the amount
of funding (exclusive
of funds that were
identified as being for
purposes of the
Minority AIDS
Initiative) that such
area received under
such part for fiscal
year 2006.
(vii) Multiple political
jurisdictions.--With respect to living
non-AIDS cases of HIV, if an eligible
area is not entirely within one
political jurisdiction and as a result
is subject to more than one reporting
system for purposes of this
subparagraph:
(I) Names-based reporting
under clause (i) applies in a
jurisdictional portion of the
area, or an exemption under
clause (ii) applies in such
portion (subject to applicable
provisions of this
subparagraph), according to
whether names-based reporting
or code-based reporting is used
in such portion.
(II) If under subclause (I)
both names-based reporting and
code-based reporting apply in
the area, the number of code-
based cases shall be reduced
under clause (vi).
(viii) List of eligible areas
meeting standard regarding December 31,
2005.--
(I) In general.--If an
eligible area or portion
thereof is in a State specified
in subclause (II), the eligible
area or portion shall be
considered to meet the standard
described in clause (ii)(I). No
other eligible area or portion
thereof may be considered to
meet such standard.
(II) Relevant states.--For
purposes of subclause (I), the
States specified in this
subclause are the following:
Alaska, Alabama, Arkansas,
Arizona, Colorado, Florida,
Indiana, Iowa, Idaho, Kansas,
Louisiana, Michigan, Minnesota,
Missouri, Mississippi, North
Carolina, North Dakota,
Nebraska, New Jersey, New
Mexico, New York, Nevada, Ohio,
Oklahoma, South Carolina, South
Dakota, Tennessee, Texas, Utah,
Virginia, Wisconsin, West
Virginia, Wyoming, Guam, and
the Virgin Islands.
(ix) Rules of construction
regarding acceptance of reports.--
(I) Cases of aids.--With
respect to an eligible area
that is subject to the
requirement under clause (i)
and is not in compliance with
the requirement for names-based
reporting of living non-AIDS
cases of HIV, the Secretary
shall, notwithstanding such
noncompliance, accept reports
of living cases of AIDS that
are in accordance with such
clause.
(II) Applicability of
exemption requirements.--The
provisions of clauses (ii)
through (viii) may not be
construed as having any legal
effect for fiscal year 2013 or
any subsequent fiscal year, and
accordingly, the status of a
State for purposes of such
clauses may not be considered
after fiscal year 2012.
(x) Program for detecting
inaccurate or fraudulent counting.--The
Secretary shall carry out a program to
monitor the reporting of names-based
cases for purposes of this subparagraph
and to detect instances of inaccurate
reporting, including fraudulent
reporting.
(xi) Future fiscal years.--For
fiscal years beginning with fiscal year
2013, determinations under this
paragraph shall be based only on living
names-based cases of HIV/AIDS with
respect to the area involved.
(D) Code-based areas; limitation on
increase in grant .--
(i) In general.--For each of the
fiscal years 2007 through 2012, if
code-based reporting (within the
meaning of subparagraph (C)(vi))
applies in an eligible area or any
portion thereof as of the beginning of
the fiscal year involved, then
notwithstanding any other provision of
this paragraph, the amount of the grant
pursuant to this paragraph for such
area for such fiscal year may not--
(I) for fiscal year 2007,
exceed by more than 5 percent
the amount of the grant for the
area that would have been made
pursuant to this paragraph and
paragraph (4) for fiscal year
2006 (as such paragraphs were
in effect for such fiscal year)
if paragraph (2) (as so in
effect) had been applied by
substituting ``66\2/3\
percent'' for ``50 percent'';
and
(II) for each of the fiscal
years 2008 through 2012, exceed
by more than 5 percent the
amount of the grant pursuant to
this paragraph and paragraph
(4) for the area for the
preceding fiscal year.
(ii) Use of amounts involved.--For
each of the fiscal years 2007 through
2012, amounts available as a result of
the limitation under clause (i) shall
be made available by the Secretary as
additional amounts for grants pursuant
to subsection (b) for the fiscal year
involved, subject to paragraph (4) and
section 2610(d)(2).
(4) Increases in grant.--
(A) In general.--For each eligible area
that received a grant pursuant to this
subsection for fiscal year 2009, the Secretary
shall, for each of the fiscal years 2010
through 2013, increase the amount of the grant
made pursuant to paragraph (3) for the area to
ensure that the amount of the grant for the
fiscal year involved is not less than the
following amount, as applicable to such fiscal
year:
(i) For fiscal year 2010, an amount
equal to 95 percent of the sum of the
amount of the grant made pursuant to
paragraph (3) and this paragraph for
fiscal year 2009.
(ii) For each of the fiscal years
2011 and 2012, an amount equal to 100
percent of the amount of the grant made
pursuant to paragraph (3) and this
paragraph for fiscal year 2010.
(iii) For fiscal year 2013, an
amount equal to 92.5 percent of the
amount of the grant made pursuant to
paragraph (3) and this paragraph for
fiscal year 2012.
(B) Source of funds for increase.--
(i) In general.--From the amounts
available for carrying out the single
program referred to in section
2609(d)(2)(C) for a fiscal year
(relating to supplemental grants), the
Secretary shall make available such
amounts as may be necessary to comply
with subparagraph (A), subject to
section 2610(d)(2).
(ii) Pro rata reduction.--If the
amounts referred to in clause (i) for a
fiscal year are insufficient to fully
comply with subparagraph (A) for the
year, the Secretary, in order to
provide the additional funds necessary
for such compliance, shall reduce on a
pro rata basis the amount of each grant
pursuant to this subsection for the
fiscal year, other than grants for
eligible areas for which increases
under subparagraph (A) apply. A
reduction under the preceding sentence
may not be made in an amount that would
result in the eligible area involved
becoming eligible for such an increase.
(C) Limitation.--This paragraph may not be
construed as having any applicability after
fiscal year 2013.
(b) Supplemental Grants.--
(1) In general.--Subject to subsection (a)(4)(B)(i)
and section 2610(d), the Secretary shall disburse the
remainder of amounts not disbursed under section
2603(a)(2) for such fiscal year for the purpose of
making grants under section 2601(a) to eligible areas
whose application under section 2605(b)--
(A) contains a report concerning the
dissemination of emergency relief funds under
subsection (a) and the plan for utilization of
such funds;
(B) demonstrates the need in such area, on
an objective and quantified basis, for
supplemental financial assistance to combat the
HIV epidemic;
(C) demonstrates the existing commitment of
local resources of the area, both financial and
in-kind, to combating the HIV epidemic;
(D) demonstrates the ability of the area to
utilize such supplemental financial resources
in a manner that is immediately responsive and
cost effective;
(E) demonstrates that resources will be
allocated in accordance with the local
demographic incidence of AIDS including
appropriate allocations for services for
infants, children, youth, women, and families
with HIV/AIDS;
(F) demonstrates the inclusiveness of
affected communities and individuals with HIV/
AIDS;
(G) demonstrates the manner in which the
proposed services are consistent with the local
needs assessment and the statewide coordinated
statement of need;
(H) demonstrates the ability of the
applicant to expend funds efficiently by not
having had, for the most recent grant year
under subsection (a) for which data is
available, more than 5 percent of grant funds
under such subsection canceled, offset under
subsection (c)(4), or covered by any waivers
under subsection (c)(3); and
(I) demonstrates success in identifying
individuals with HIV/AIDS as described in
clauses (i) through (iii) of paragraph (2)(A).
(2) Amount of grant.--
(A) In general.--The amount of each grant
made for purposes of this subsection shall be
determined by the Secretary based on a
weighting of factors under paragraph (1), with
demonstrated need under subparagraph (B) of
such paragraph counting one-third, and
demonstrated success in identifying individuals
with HIV/AIDS who do not know their HIV status
and making them aware of such status counting
one-third. In making such determination, the
Secretary shall consider--
(i) the number of individuals who
have been tested for HIV/AIDS;
(ii) of those individuals described
in clause (i), the number of
individuals who tested for HIV/AIDS who
are made aware of their status,
including the number who test positive;
and
(iii) of those individuals
described in clause (ii), the number
who have been referred to appropriate
treatment and care.
(B) Demonstrated need.--The factors
considered by the Secretary in determining
whether an eligible area has a demonstrated
need for purposes of paragraph (1)(B) may
include any or all of the following:
(i) The unmet need for such
services, as determined under section
2602(b)(4) or other community input
process as defined under section
2609(d)(1)(A).
(ii) An increasing need for HIV/
AIDS-related services, including
relative rates of increase in the
number of cases of HIV/AIDS.
(iii) The relative rates of
increase in the number of cases of HIV/
AIDS within new or emerging
subpopulations.
(iv) The current prevalence of HIV/
AIDS.
(v) Relevant factors related to the
cost and complexity of delivering
health care to individuals with HIV/
AIDS in the eligible area.
(vi) The impact of co-morbid
factors, including co-occurring
conditions, determined relevant by the
Secretary.
(vii) The prevalence of
homelessness.
(viii) The prevalence of
individuals described under section
2602(b)(2)(M).
(ix) The relevant factors that
limit access to health care, including
geographic variation, adequacy of
health insurance coverage, and language
barriers.
(x) The impact of a decline in the
amount received pursuant to subsection
(a) on services available to all
individuals with HIV/AIDS identified
and eligible under this title.
(C) Priority in making grants.--The
Secretary shall provide funds under this
subsection to an eligible area to address the
decline or disruption of all EMA-provided
services related to the decline in the amounts
received pursuant to subsection (a) consistent
with the grant award for the eligible area for
fiscal year 2006, to the extent that the factor
under subparagraph (B)(x) (relating to a
decline in funding) applies to the eligible
area.
(D) Increased adjustment for certain areas
previously using code-based reporting.--For
purposes of this subsection for each of fiscal
years 2010 through 2012, the Secretary shall
deem the applicable number of living cases of
HIV/AIDS in an area that were reported to and
confirmed by the Centers for Disease Control
and Prevention to be 3 percent higher than the
actual number if the conditions described in
items (aa) through (cc) of subsection
(a)(3)(C)(vi)(III) are all satisfied.
(3) Remainder of amounts.--In determining the
amount of funds to be obligated under paragraph (1),
the Secretary shall include amounts that are not paid
to the eligible areas under expedited procedures under
section 2603(a)(2) as a result of--
(A) the failure of any eligible area to
submit an application under section 2605(c); or
(B) any eligible area informing the
Secretary that such eligible area does not
intend to expend the full amount of its grant
under such section.
(4) Failure to submit.--
(A) In general.--The failure of an eligible
area to submit an application for an expedited
grant under section 2603(a)(2) shall not result
in such area being ineligible for a grant under
this subsection.
(B) Application.--The application of an
eligible area submitted under section 2605(b)
shall contain the assurances required under
subsection (a) of such section if such eligible
area fails to submit an application for an
expedited grant under section 2603(a)(2).
(c) Timeframe for Obligation and Expenditure of Grant
Funds.--
(1) Obligation by end of grant year.--Effective for
fiscal year 2007 and subsequent fiscal years, funds
from a grant award made pursuant to subsection (a) or
(b) for a fiscal year are available for obligation by
the eligible area involved through the end of the one-
year period beginning on the date in such fiscal year
on which funds from the award first become available to
the area (referred to in this subsection as the ``grant
year for the award''), except as provided in paragraph
(3)(A).
(2) Supplemental grants; cancellation of
unobligated balance of grant award.--Effective for
fiscal year 2007 and subsequent fiscal years, if a
grant award made pursuant to subsection (b) for an
eligible area for a fiscal year has an unobligated
balance as of the end of the grant year for the award--
(A) the Secretary shall cancel that
unobligated balance of the award, and shall
require the eligible area to return any amounts
from such balance that have been disbursed to
the area; and
(B) the funds involved shall be made
available by the Secretary as additional
amounts for grants pursuant to subsection (b)
for the first fiscal year beginning after the
fiscal year in which the Secretary obtains the
information necessary for determining that the
balance is required under subparagraph (A) to
be canceled, except that the availability of
the funds for such grants is subject to
subsection (a)(4) and section 2610(d)(2) as
applied for such year.
(3) Formula grants; cancellation of unobligated
balance of grant award; waiver permitting carryover.--
(A) In general.--Effective for fiscal year
2007 and subsequent fiscal years, if a grant
award made pursuant to subsection (a) for an
eligible area for a fiscal year has an
unobligated balance as of the end of the grant
year for the award, the Secretary shall cancel
that unobligated balance of the award, and
shall require the eligible area to return any
amounts from such balance that have been
disbursed to the area, unless--
(i) before the end of the grant
year, the chief elected official of the
area submits to the Secretary a written
application for a waiver of the
cancellation, which application
includes a description of the purposes
for which the area intends to expend
the funds involved; and
(ii) the Secretary approves the
waiver.
(B) Expenditure by end of carryover year.--
With respect to a waiver under subparagraph (A)
that is approved for a balance that is
unobligated as of the end of a grant year for
an award:
(i) The unobligated funds are
available for expenditure by the
eligible area involved for the one-year
period beginning upon the expiration of
the grant year (referred to in this
subsection as the ``carryover year'').
(ii) If the funds are not expended
by the end of the carryover year, the
Secretary shall cancel that unexpended
balance of the award, and shall require
the eligible area to return any amounts
from such balance that have been
disbursed to the area.
(C) Use of cancelled balances.--In the case
of any balance of a grant award that is
cancelled under subparagraph (A) or (B)(ii),
the grant funds involved shall be made
available by the Secretary as additional
amounts for grants pursuant to subsection (b)
for the first fiscal year beginning after the
fiscal year in which the Secretary obtains the
information necessary for determining that the
balance is required under such subparagraph to
be canceled, except that the availability of
the funds for such grants is subject to
subsection (a)(4) and section 2610(d)(2) as
applied for such year.
(D) Corresponding reduction in future
grant.--
(i) In general.--In the case of an
eligible area for which a balance from
a grant award under subsection (a) is
unobligated as of the end of the grant
year for the award--
(I) the Secretary shall
reduce, by the same amount as
such unobligated balance (less
any amount of such balance that
is the subject of a waiver of
cancellation under subparagraph
(A)), the amount of the grant
under such subsection for the
first fiscal year beginning
after the fiscal year in which
the Secretary obtains the
information necessary for
determining that such balance
was unobligated as of the end
of the grant year (which
requirement for a reduction
applies without regard to
whether a waiver under
subparagraph (A) has been
approved with respect to such
balance); and
(II) the grant funds
involved in such reduction
shall be made available by the
Secretary as additional funds
for grants pursuant to
subsection (b) for such first
fiscal year, subject to
subsection (a)(4) and section
2610(d)(2);
except that this clause does not apply
to the eligible area if the amount of
the unobligated balance was 5 percent
or less.
(ii) Relation to increases in
grant.--A reduction under clause (i)
for an eligible area for a fiscal year
may not be taken into account in
applying subsection (a)(4) with respect
to the area for the subsequent fiscal
year.
(4) Authority regarding administration of
provisions.--In administering paragraphs (2) and (3)
with respect to the unobligated balance of an eligible
area, the Secretary may elect to reduce the amount of
future grants to the area under subsection (a) or (b),
as applicable, by the amount of any such unobligated
balance in lieu of cancelling such amount as provided
for in paragraph (2) or (3)(A). In such case, the
Secretary may permit the area to use such unobligated
balance for purposes of any such future grant. An
amount equal to such reduction shall be available for
use as additional amounts for grants pursuant to
subsection (b), subject to subsection (a)(4) and
section 2610(d)(2). Nothing in this paragraph shall be
construed to affect the authority of the Secretary
under paragraphs (2) and (3), including the authority
to grant waivers under paragraph (3)(A). The reduction
in future grants authorized under this paragraph shall
be notwithstanding the penalty required under paragraph
(3)(D) with respect to unobligated funds.
(d) Compliance With Priorities of HIV Planning Council.--
Notwithstanding any other provision of this subpart, the
Secretary, in carrying out section 2601(a), may not make any
grant under subsection (a) or (b) to an eligible area unless
the application submitted by such area under section 2605 for
the grant involved demonstrates that the grants made under
subsections (a) and (b) to the area for the preceding fiscal
year (if any) were expended in accordance with the priorities
applicable to such year that were established, pursuant to
section 2602(b)(4)(C), by the planning council serving the
area.
(e) Report on the Awarding of Supplemental Funds.--Not
later than 45 days after the awarding of supplemental funds
under this section, the Secretary shall submit to Congress a
report concerning such funds. Such report shall include
information detailing--
(1) the total amount of supplemental funds
available under this section for the year involved;
(2) the amount of supplemental funds used in
accordance with the hold harmless provisions of
subsection (a)(4);
(3) the amount of supplemental funds disbursed
pursuant to subsection (b)(2)(C);
(4) the disbursement of the remainder of the
supplemental funds after taking into account the uses
described in paragraphs (2) and (3); and
(5) the rationale used for the amount of funds
disbursed as described under paragraphs (2), (3), and
(4).
SEC. 2604. [300FF-14] USE OF AMOUNTS.
(a) Requirements.--The Secretary may not make a grant under
section 2601(a) to the chief elected official of an eligible
area unless such political subdivision agrees that--
(1) subject to paragraph (2), the allocation of
funds and services within the eligible area will be
made in accordance with the priorities established,
pursuant to section 2602(b)(4)(C), by the HIV health
services planning council that serves such eligible
area;
(2) funds provided under section 2601 will be
expended only for--
(A) core medical services described in
subsection (c);
(B) support services described in
subsection (d); and
(C) administrative expenses described in
subsection (h); and
(3) the use of such funds will comply with the
requirements of this section.
(b) Direct Financial Assistance to Appropriate Entities.--
(1) In general.--The chief elected official of an
eligible area shall use amounts from a grant under
section 2601 to provide direct financial assistance to
entities described in paragraph (2) for the purpose of
providing core medical services and support services.
(2) Appropriate entities.--Direct financial
assistance may be provided under paragraph (1) to
public or nonprofit private entities, or private for-
profit entities if such entities are the only available
provider of quality HIV care in the area.
(c) Required Funding for Core Medical Services.--
(1) In general.--With respect to a grant under
section 2601 for an eligible area for a grant year, the
chief elected official of the area shall, of the
portion of the grant remaining after reserving amounts
for purposes of paragraphs (1) and (5)(B)(i) of
subsection (h), use not less than 75 percent to provide
core medical services that are needed in the eligible
area for individuals with HIV/AIDS who are identified
and eligible under this title (including services
regarding the co-occurring conditions of the
individuals).
(2) Waiver.--
(A) In general.--The Secretary shall waive
the application of paragraph (1) with respect
to a chief elected official for a grant year if
the Secretary determines that, within the
eligible area involved--
(i) there are no waiting lists for
AIDS Drug Assistance Program services
under section 2616; and
(ii) core medical services are
available to all individuals with HIV/
AIDS identified and eligible under this
title.
(B) Notification of waiver status.--When
informing the chief elected official of an
eligible area that a grant under section 2601
is being made for the area for a grant year,
the Secretary shall inform the official whether
a waiver under subparagraph (A) is in effect
for such year.
(3) Core medical services.--For purposes of this
subsection, the term ``core medical services'', with
respect to an individual with HIV/AIDS (including the
co-occurring conditions of the individual), means the
following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments
in accordance with section 2616.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (e).
(F) Health insurance premium and cost
sharing assistance for low-income individuals
in accordance with section 2615.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 2614(c).
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(d) Support Services.--
(1) In general.--For purposes of this section, the
term ``support services'' means services, subject to
the approval of the Secretary, that are needed for
individuals with HIV/AIDS to achieve their medical
outcomes (such as respite care for persons caring for
individuals with HIV/AIDS, outreach services, medical
transportation, linguistic services, and referrals for
health care and support services).
(2) Medical outcomes.--In this subsection, the term
``medical outcomes'' means those outcomes affecting the
HIV-related clinical status of an individual with HIV/
AIDS.
(e) Early Intervention Services.--
(1) In general.--For purposes of this section, the
term ``early intervention services'' means HIV/AIDS
early intervention services described in section
2651(e), with follow-up referral provided for the
purpose of facilitating the access of individuals
receiving the services to HIV-related health services.
The entities through which such services may be
provided under the grant include public health
departments, emergency rooms, substance abuse and
mental health treatment programs, detoxification
centers, detention facilities, clinics regarding
sexually transmitted diseases, homeless shelters, HIV/
AIDS counseling and testing sites, health care points
of entry specified by eligible areas, federally
qualified health centers, and entities described in
section 2652(a) that constitute a point of access to
services by maintaining referral relationships.
(2) Conditions.--With respect to an entity that
proposes to provide early intervention services under
paragraph (1), such paragraph shall apply only if the
entity demonstrates to the satisfaction of the chief
elected official for the eligible area involved that--
(A) Federal, State, or local funds are
otherwise inadequate for the early intervention
services the entity proposes to provide; and
(B) the entity will expend funds pursuant
to such paragraph to supplement and not
supplant other funds available to the entity
for the provision of early intervention
services for the fiscal year involved.
(f) Priority for Women, Infants, Children, and Youth.--
(1) In general.--For the purpose of providing
health and support services to infants, children,
youth, and women with HIV/AIDS, including treatment
measures to prevent the perinatal transmission of HIV,
the chief elected official of an eligible area, in
accordance with the established priorities of the
planning council, shall for each of such populations in
the eligible area use, from the grants made for the
area under section 2601(a) for a fiscal year, not less
than the percentage constituted by the ratio of the
population involved (infants, children, youth, or women
in such area) with HIV/AIDS to the general population
in such area of individuals with HIV/AIDS.
(2) Waiver.--With respect to the population
involved, the Secretary may provide to the chief
elected official of an eligible area a waiver of the
requirement of paragraph (1) if such official
demonstrates to the satisfaction of the Secretary that
the population is receiving HIV-related health services
through the State medicaid program under title XIX of
the Social Security Act, the State children's health
insurance program under title XXI of such Act, or other
Federal or State programs.
(g) Requirement of Status as Medicaid Provider.--
(1) Provision of service.--Subject to paragraph
(2), the Secretary may not make a grant under section
2601(a) for the provision of services under this
section in a State unless, in the case of any such
service that is available pursuant to the State plan
approved under title XIX of the Social Security Act for
the State--
(A) the political subdivision involved will
provide the service directly, and the political
subdivision has entered into a participation
agreement under the State plan and is qualified
to receive payments under such plan; or
(B) the political subdivision will enter
into an agreement with a public or nonprofit
private entity under which the entity will
provide the service, and the entity has entered
into such a participation agreement and is
qualified to receive such payments.
(2) Waiver.--
(A) In general.--In the case of an entity
making an agreement pursuant to paragraph
(1)(B) regarding the provision of services, the
requirement established in such paragraph shall
be waived by the HIV health services planning
council for the eligible area if the entity
does not, in providing health care services,
impose a charge or accept reimbursement
available from any third-party payor, including
reimbursement under any insurance policy or
under any Federal or State health benefits
program.
(B) Determination.--A determination by the
HIV health services planning council of whether
an entity referred to in subparagraph (A) meets
the criteria for a waiver under such
subparagraph shall be made without regard to
whether the entity accepts voluntary donations
for the purpose of providing services to the
public.
(h) Administration.--
(1) Limitation.--The chief elected official of an
eligible area shall not use in excess of 10 percent of
amounts received under a grant under this subpart for
administrative expenses.
(2) Allocations by chief elected official.--In the
case of entities and subcontractors to which the chief
elected official of an eligible area allocates amounts
received by the official under a grant under this
subpart, the official shall ensure that, of the
aggregate amount so allocated, the total of the
expenditures by such entities for administrative
expenses does not exceed 10 percent (without regard to
whether particular entities expend more than 10 percent
for such expenses).
(3) Administrative activities.--For purposes of
paragraph (1), amounts may be used for administrative
activities that include--
(A) routine grant administration and
monitoring activities, including the
development of applications for part A funds,
the receipt and disbursal of program funds, the
development and establishment of reimbursement
and accounting systems, the development of a
clinical quality management program as
described in paragraph (5), the preparation of
routine programmatic and financial reports, and
compliance with grant conditions and audit
requirements; and
(B) all activities associated with the
grantee's contract award procedures, including
the activities carried out by the HIV health
services planning council as established under
section 2602(b), the development of requests
for proposals, contract proposal review
activities, negotiation and awarding of
contracts, monitoring of contracts through
telephone consultation, written documentation
or onsite visits, reporting on contracts, and
funding reallocation activities.
(4) Subcontractor administrative activities.--For
the purposes of this subsection, subcontractor
administrative activities include--
(A) usual and recognized overhead
activities, including established indirect
rates for agencies;
(B) management oversight of specific
programs funded under this title; and
(C) other types of program support such as
quality assurance, quality control, and related
activities.
(5) Clinical quality management.--
(A) Requirement.--The chief elected
official of an eligible area that receives a
grant under this subpart shall provide for the
establishment of a clinical quality management
program to assess the extent to which HIV
health services provided to patients under the
grant are consistent with the most recent
Public Health Service guidelines for the
treatment of HIV/AIDS and related opportunistic
infection, and as applicable, to develop
strategies for ensuring that such services are
consistent with the guidelines for improvement
in the access to and quality of HIV health
services.
(B) Use of funds.--
(i) In general.--From amounts
received under a grant awarded under
this subpart for a fiscal year, the
chief elected official of an eligible
area may use for activities associated
with the clinical quality management
program required in subparagraph (A)
not to exceed the lesser of--
(I) 5 percent of amounts
received under the grant; or
(II) $3,000,000.
(ii) Relation to limitation on
administrative expenses.--The costs of
a clinical quality management program
under subparagraph (A) may not be
considered administrative expenses for
purposes of the limitation established
in paragraph (1).
(i) Construction.--A chief elected official may not use
amounts received under a grant awarded under this subpart to
purchase or improve land, or to purchase, construct, or
permanently improve (other than minor remodeling) any building
or other facility, or to make cash payments to intended
recipients of services.
SEC. 2605. [300FF-15] APPLICATION.
(a) In General.--To be eligible to receive a grant under
section 2601, an eligible area shall prepare and submit to the
Secretary an application, in accordance with subsection (c)
regarding a single application and grant award, at such time,
in such form, and containing such information as the Secretary
shall require, including assurances adequate to ensure--
(1)(A) that funds received under a grant awarded
under this subpart will be utilized to supplement not
supplant State funds made available in the year for
which the grant is awarded to provide HIV-related
services as described in section 2604(b)(1);
(B) that the political subdivisions within the
eligible area will maintain the level of expenditures
by such political subdivisions for HIV-related services
as described in section 2604(b)(1) at a level that is
equal to the level of such expenditures by such
political subdivisions for the preceding fiscal year;
and
(C) that political subdivisions within the eligible
area will not use funds received under a grant awarded
under this subpart in maintaining the level of
expenditures for HIV-related services as required in
subparagraph (B);
(2) that the eligible area has an HIV health
services planning council and has entered into
intergovernmental agreements pursuant to section 2602,
and has developed or will develop the comprehensive
plan in accordance with section 2602(b)(3)(B);
(3) that entities within the eligible area that
receive funds under a grant under this subpart will
maintain appropriate relationships with entities in the
eligible area served that constitute key points of
access to the health care system for individuals with
HIV/AIDS (including emergency rooms, substance abuse
treatment programs, detoxification centers, adult and
juvenile detention facilities, sexually transmitted
disease clinics, HIV counseling and testing sites,
mental health programs, and homeless shelters), and
other entities under section 2604(b)(3) and 2652(a),
for the purpose of facilitating early intervention for
individuals newly diagnosed with HIV/AIDS and
individuals knowledgeable of their HIV status but not
in care;
(4) that the chief elected official of the eligible
area will satisfy all requirements under section
2604(c);
(5) that entities within the eligible area that
will receive funds under a grant provided under section
2601(a) shall participate in an established HIV
community-based continuum of care if such continuum
exists within the eligible area;
(6) that funds received under a grant awarded under
this subpart will not be utilized to make payments for
any item or service to the extent that payment has been
made, or can reasonably be expected to be made, with
respect to that item or service--
(A) under any State compensation program,
under an insurance policy, or under any Federal
or State health benefits program (except for a
program administered by or providing the
services of the Indian Health Service); or
(B) by an entity that provides health
services on a prepaid basis;
(7) to the maximum extent practicable, that--
(A) HIV health care and support services
provided with assistance made available under
this subpart will be provided without regard--
(i) to the ability of the
individual to pay for such services;
and
(ii) to the current or past health
condition of the individual to be
served;
(B) such services will be provided in a
setting that is accessible to low-income
individuals with HIV-disease; and
(C) a program of outreach will be provided
to low-income individuals with HIV-disease to
inform such individuals of such services;
(8) that the applicant has participated, or will
agree to participate, in the statewide coordinated
statement of need process where it has been initiated
by the State public health agency responsible for
administering grants under part B, and ensure that the
services provided under the comprehensive plan are
consistent with the statewide coordinated statement of
need;
(9) that the eligible area has procedures in place
to ensure that services provided with funds received
under this subpart meet the criteria specified in
section 2604(b)(1); and
(10) that the chief elected official will submit to
the lead State agency under section 2617(b)(4), audits,
consistent with Office of Management and Budget
circular A133, regarding funds expended in accordance
with this subpart every 2 years and shall include
necessary client-based data to compile unmet need
calculations and Statewide coordinated statements of
need process.
(b) Application.--An eligible area that desires to receive
a grant under section 2603(b) shall prepare and submit to the
Secretary an application, in accordance with subsection (c)
regarding a single application and grant award, at such time,
in such form, and containing such information as the Secretary
shall require, including the information required under such
subsection and information concerning--
(1) the number of individuals to be served within
the eligible area with assistance provided under the
grant, including the identification of individuals with
HIV/AIDS as described in clauses (i) through (iii) of
section 2603(b)(2)(A);
(2) demographic data on the population of such
individuals;
(3) the average cost of providing each category of
HIV-related health services and the extent to which
such cost is paid by third-party payors;
(4) the aggregate amounts expended for each such
category of services;
(5) the manner in which the expected expenditures
are related to the planning process for States that
receive funding under part B (including the planning
process described in section 2617(b)); and
(6) the expected expenditures and how those
expenditures will improve overall client outcomes, as
described under the State plan under section 2617(b),
and through additional outcomes measures as identified
by the HIV health services planning council under
section 2602(b).
(c) Single Application and Grant Award.--
(1) Application.--The Secretary may phase in the
use of a single application that meets the requirements
of subsections (a) and (b) of section 2603 with respect
to an eligible area that desires to receive grants
under section 2603 for a fiscal year.
(2) Grant award.--The Secretary may phase in the
awarding of a single grant to an eligible area that
submits an approved application under paragraph (1) for
a fiscal year.
(d) Date Certain for Submission.--
(1) Requirement.--Except as provided in paragraph
(2), to be eligible to receive a grant under section
2601(a) for a fiscal year, an application under
subsection (a) shall be submitted not later than 45
days after the date on which appropriations are made
under section 2677 for the fiscal year.
(2) Exception.--The Secretary may extend the time
for the submission of an application under paragraph
(1) for a period of not to exceed 60 days if the
Secretary determines that the eligible area has made a
good faith effort to comply with the requirement of
such paragraph but has otherwise been unable to submit
its application.
(3) Distribution by Secretary.--Not later than 45
days after receiving an application that meets the
requirements of subsection (a) from an eligible area,
the Secretary shall distribute to such eligible area
the amounts awarded under the grant for which the
application was submitted.
(4) Redistribution.--Any amounts appropriated in
any fiscal year under this subpart and not obligated to
an eligible entity as a result of the failure of such
entity to submit an application shall be redistributed
by the Secretary to other eligible entities in
proportion to the original grants made to such eligible
areas under section 2601(a).
(e) Requirements Regarding Imposition of Charges for
Services.--
(1) In general.--The Secretary may not make a grant
under section 2601 to an eligible area unless the
eligible area provides assurances that in the provision
of services with assistance provided under the grant--
(A) in the case of individuals with an
income less than or equal to 100 percent of the
official poverty line, the provider will not
impose charges on any such individual for the
provision of services under the grant;
(B) in the case of individuals with an
income greater than 100 percent of the official
poverty line, the provider--
(i) will impose a charge on each
such individual for the provision of
such services; and
(ii) will impose the charge
according to a schedule of charges that
is made available to the public;
(C) in the case of individuals with an
income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an amount
exceeding 5 percent of the annual gross income
of the individual involved;
(D) in the case of individuals with an
income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an amount
exceeding 7 percent of the annual gross income
of the individual involved; and
(E) in the case of individuals with an
income greater than 300 percent of the official
poverty line, the provider will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income
of the individual involved.
(2) Assessment of charge.--With respect to
compliance with the assurance made under paragraph (1),
a grantee or entity receiving assistance under this
subpart may, in the case of individuals subject to a
charge for purposes of such paragraph--
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules and
regarding limitations on the maximum amount of
charges; and
(B) take into consideration the medical
expenses of individuals in assessing the amount
of the charge, subject to such provisions.
(3) Applicability of limitation on amount of
charge.--The Secretary may not make a grant under
section 2601 to an eligible area unless the eligible
area agrees that the limitations established in
subparagraphs (C), (D) and (E) of paragraph (1)
regarding the imposition of charges for services
applies to the annual aggregate of charges imposed for
such services, without regard to whether they are
characterized as enrollment fees, premiums,
deductibles, cost sharing, copayments, coinsurance, or
other charges.
(4) Waiver regarding secondary agreements.--The
requirements established in paragraphs (1) through (3)
shall be waived in accordance with section 2604(d)(2).
SEC. 2606. [300FF-16] TECHNICAL ASSISTANCE.
The Administrator of the Health Resources and Services
Administration shall, beginning on the date of enactment of
this title, provide technical assistance, including assistance
from other grantees, contractors or subcontractors under this
title to assist newly eligible metropolitan areas in the
establishment of HIV health services planning councils and, to
assist entities in complying with the requirements of this
subpart in order to make such entities eligible to receive a
grant under this subpart. The Administrator may make planning
grants available to metropolitan areas, in an amount not to
exceed $75,000 for any metropolitan area, projected to be
eligible for funding under section 2601 in the following fiscal
year. Such grant amounts shall be deducted from the first year
formula award to eligible areas accepting such grants. Not to
exceed 1 percent of the amount appropriated for a fiscal year
under section 2677 for grants under part A may be used to carry
out this section.
SEC. 2607. [300FF-17] DEFINITIONS.
For purposes of this subpart:
(1) Eligible area.--The term ``eligible area''
means a metropolitan area meeting the requirements of
section 2601 that are applicable to the area.
(2) Metropolitan area.--The term ``metropolitan
area'' means an area that is referred to in the HIV/
AIDS Surveillance Report of the Centers for Disease
Control and Prevention as a metropolitan area, and that
has a population of 50,000 or more individuals.
Subpart II--Transitional Grants
SEC. 2609. [300FF-19] ESTABLISHMENT OF PROGRAM.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall make grants for the purpose of providing
services described in section 2604 in transitional areas,
subject to the same provisions regarding the allocation of
grant funds as apply under subsection (c) of such section.
(b) Transitional Areas.--For purposes of this section, the
term ``transitional area'' means, subject to subsection (c), a
metropolitan area for which there has been reported to and
confirmed by the Director of the Centers for Disease Control
and Prevention a cumulative total of at least 1,000, but fewer
than 2,000, cases of AIDS during the most recent period of 5
calendar years for which such data are available.
(c) Certain Eligibility Rules.--
(1) Fiscal year 2011.--With respect to grants under
subsection (a) for fiscal year 2011, a metropolitan
area that received funding under subpart I for fiscal
year 2010 but does not for fiscal year 2011 qualify
under such subpart as an eligible area and does not
qualify under subsection (b) as a transitional area
shall, notwithstanding subsection (b), be considered a
transitional area.
(2) Continued status as transitional area.--
(A) In general.--Notwithstanding subsection
(b), a metropolitan area that is a transitional
area for a fiscal year continues, except as
provided in subparagraph (B), to be a
transitional area until the metropolitan area
fails, for three consecutive fiscal years--
(i) to qualify under such
subsection as a transitional area; and
(ii) subject to subparagraphs (B)
and (C), to have a cumulative total of
1,500 or more living cases of AIDS
(reported to and confirmed by the
Director of the Centers for Disease
Control and Prevention) as of December
31 of the most recent calendar year for
which such data is available.
(B) Permitting margin of error applicable
to certain metropolitan areas.--In applying
subparagraph (A)(ii) for a fiscal year after
fiscal year 2008, in the case of a metropolitan
area that has a cumulative total of at least
1,400 (and fewer than 1,500) living cases of
AIDS as of December 31 of the most recent
calendar year for which such data is available,
such area shall be treated as having met the
criteria of such subparagraph if not more than
5 percent of the total from grants awarded to
such area under this part is unobligated as of
the end of the most recent fiscal year for
which such data is available.
(C) Exception regarding status as eligible
area.--Subparagraphs (A) and (B) do not apply
for a fiscal year if the metropolitan area
involved qualifies under subpart I as an
eligible area.
(d) Application of Certain Provisions of Subpart I.--
(1) Administration; planning council.--
(A) In general.--The provisions of section
2602 apply with respect to a grant under
subsection (a) for a transitional area to the
same extent and in the same manner as such
provisions apply with respect to a grant under
subpart I for an eligible area, except that,
subject to subparagraph (B), the chief elected
official of the transitional area may elect not
to comply with the provisions of section
2602(b) if the official provides documentation
to the Secretary that details the process used
to obtain community input (particularly from
those with HIV) in the transitional area for
formulating the overall plan for priority
setting and allocating funds from the grant
under subsection (a).
(B) Exception.--For each of the fiscal
years 2007 through 2013, the exception
described in subparagraph (A) does not apply if
the transitional area involved received funding
under subpart I for fiscal year 2006.
(2) Type and distribution of grants; timeframe for
obligation and expenditure of grant funds.--
(A) Formula grants; supplemental grants.--
The provisions of section 2603 apply with
respect to grants under subsection (a) to the
same extent and in the same manner as such
provisions apply with respect to grants under
subpart I, subject to subparagraphs (B) and
(C).
(B) Formula grants; increase in grant.--For
purposes of subparagraph (A), section
2603(a)(4) does not apply.
(C) Supplemental grants; single program
with subpart i program.--With respect to
section 2603(b) as applied for purposes of
subparagraph (A):
(i) The Secretary shall combine
amounts available pursuant to such
subparagraph with amounts available for
carrying out section 2603(b) and shall
administer the two programs as a single
program.
(ii) In the single program, the
Secretary has discretion in allocating
amounts between eligible areas under
subpart I and transitional areas under
this section, subject to the
eligibility criteria that apply under
such section, and subject to section
2603(b)(2)(C) (relating to priority in
making grants).
(iii) Pursuant to section
2603(b)(1), amounts for the single
program are subject to use under
sections 2603(a)(4) and 2610(d)(1).
(3) Application; technical assistance;
definitions.--The provisions of sections 2605, 2606,
and 2607 apply with respect to grants under subsection
(a) to the same extent and in the same manner as such
provisions apply with respect to grants under subpart
I.
Subpart III--General Provisions
SEC. 2610. [300FF-20] AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out this part,
there are authorized to be appropriated $604,000,000 for fiscal
year 2007, $626,300,000 for fiscal year 2008, $649,500,000 for
fiscal year 2009, $681,975,000 for fiscal year 2010,
$716,074,000 for fiscal year 2011, $751,877,000 for fiscal year
2012, and $789,471,000 for fiscal year 2013. Amounts
appropriated under the preceding sentence for a fiscal year are
available for obligation by the Secretary until the end of the
second succeeding fiscal year.
(b) Reservation of Amounts.--
(1) Fiscal year 2007.--Of the amount appropriated
under subsection (a) for fiscal year 2007, the
Secretary shall reserve--
(A) $458,310,000 for grants under subpart
I; and
(B) $145,690,000 for grants under section
2609.
(2) Subsequent fiscal years.--Of the amount
appropriated under subsection (a) for fiscal year 2008
and each subsequent fiscal year--
(A) the Secretary shall reserve an amount
for grants under subpart I; and
(B) the Secretary shall reserve an amount
for grants under section 2609.
(c) Transfer of Certain Amounts; Change in Status as
Eligible Area or Transitional Area.--Notwithstanding subsection
(b):
(1) If a metropolitan area is an eligible area
under subpart I for a fiscal year, but for a subsequent
fiscal year ceases to be an eligible area by reason of
section 2601(b)--
(A)(i) the amount reserved under paragraph
(1)(A) or (2)(A) of subsection (b) of this
section for the first such subsequent year of
not being an eligible area is deemed to be
reduced by an amount equal to the amount of the
grant made pursuant to section 2603(a) for the
metropolitan area for the preceding fiscal
year; and
(ii)(I) if the metropolitan area qualifies
for such first subsequent fiscal year as a
transitional area under 2609, the amount
reserved under paragraph (1)(B) or (2)(B) of
subsection (b) for such fiscal year is deemed
to be increased by an amount equal to the
amount of the reduction under subparagraph (A)
for such year; or
(II) if the metropolitan area does not
qualify for such first subsequent fiscal year
as a transitional area under 2609, an amount
equal to the amount of such reduction is,
notwithstanding subsection (a), transferred and
made available for grants pursuant to section
2618(a)(1), in addition to amounts available
for such grants under section 2623; and
(B) if a transfer under subparagraph
(A)(ii)(II) is made with respect to the
metropolitan area for such first subsequent
fiscal year, then--
(i) the amount reserved under
paragraph (1)(A) or (2)(A) of
subsection (b) of this section for such
year is deemed to be reduced by an
additional $500,000; and
(ii) an amount equal to the amount
of such additional reduction is,
notwithstanding subsection (a),
transferred and made available for
grants pursuant to section 2618(a)(1),
in addition to amounts available for
such grants under section 2623.
(2) If a metropolitan area is a transitional area
under section 2609 for a fiscal year, but for a
subsequent fiscal year ceases to be a transitional area
by reason of section 2609(c)(2) (and does not qualify
for such subsequent fiscal year as an eligible area
under subpart I)--
(A) the amount reserved under subsection
(b)(2)(B) of this section for the first such
subsequent fiscal year of not being a
transitional area is deemed to be reduced by an
amount equal to the total of--
(i) the amount of the grant that,
pursuant to section 2603(a), was made
under section 2609(d)(2)(A) for the
metropolitan area for the preceding
fiscal year; and
(ii) $500,000; and
(B)(i) subject to clause (ii), an amount
equal to the amount of the reduction under
subparagraph (A) for such year is,
notwithstanding subsection (a), transferred and
made available for grants pursuant to section
2618(a)(1), in addition to amounts available
for such grants under section 2623; and
(ii) for each of fiscal years 2010 through
2013, notwithstanding subsection (a)--
(I) there shall be transferred to
the State containing the metropolitan
area, for purposes described in section
2612(a), an amount (which shall not be
taken into account in applying section
2618(a)(2)(H)) equal to--
(aa) for the first fiscal
year of the metropolitan area
not being a transitional area,
75 percent of the amount
described in subparagraph
(A)(i) for such area;
(bb) for the second fiscal
year of the metropolitan area
not being a transitional area,
50 percent of such amount; and
(cc) for the third fiscal
year of the metropolitan area
not being a transitional area,
25 percent of such amount; and
(II) there shall be transferred and
made available for grants pursuant to
section 2618(a)(1) for the fiscal year,
in addition to amounts available for
such grants under section 2623, an
amount equal to the total amount of the
reduction for such fiscal year under
subparagraph (A), less the amount
transferred for such fiscal year under
subclause (I).
(3) If a metropolitan area is a transitional area
under section 2609 for a fiscal year, but for a
subsequent fiscal year qualifies as an eligible area
under subpart I--
(A) the amount reserved under subsection
(b)(2)(B) of this section for the first such
subsequent fiscal year of becoming an eligible
area is deemed to be reduced by an amount equal
to the amount of the grant that, pursuant to
section 2603(a), was made under section
2609(d)(2)(A) for the metropolitan area for the
preceding fiscal year; and
(B) the amount reserved under subsection
(b)(2)(A) for such fiscal year is deemed to be
increased by an amount equal to the amount of
the reduction under subparagraph (A) for such
year.
(d) Certain Transfers; Allocations Between Programs Under
Subpart I.--With respect to paragraphs (1)(B)(i) and (2)(A)(ii)
of subsection (c), the Secretary shall administer any
reductions under such paragraphs for a fiscal year in
accordance with the following:
(1) The reductions shall be made from amounts
available for the single program referred to in section
2609(d)(2)(C) (relating to supplemental grants).
(2) The reductions shall be made before the amounts
referred to in paragraph (1) are used for purposes of
section 2603(a)(4).
(3) If the amounts referred to in paragraph (1) are
not sufficient for making all the reductions, the
reductions shall be reduced until the total amount of
the reductions equals the total of the amounts referred
to in such paragraph.
(e) Rules of Construction Regarding First Subsequent Fiscal
Year.--Paragraphs (1) and (2) of subsection (c) apply with
respect to each series of fiscal years during which a
metropolitan area is an eligible area under subpart I or a
transitional area under section 2609 for a fiscal year and then
for a subsequent fiscal year ceases to be such an area by
reason of section 2601(b) or 2609(c)(2), respectively, rather
than applying to a single such series. Paragraph (3) of
subsection (c) applies with respect to each series of fiscal
years during which a metropolitan area is a transitional area
under section 2609 for a fiscal year and then for a subsequent
fiscal year becomes an eligible area under subpart I, rather
than applying to a single such series.
Part B--Care Grant Program 1, 2
Subpart I--General Grant Provisions
SEC. 2611. [300FF-21] GRANTS.
The Secretary shall, subject to the availability of
appropriations, make grants to States to enable such States to
improve the quality, availability and organization of health
care and support services for individuals and families with
HIV/AIDS. The authority of the Secretary to provide grants
under part B is subject to section 2626(e)(2) (relating to the
decrease in perinatal transmission of HIV/AIDS).
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\1\ Section 8(a) of Public Law 104-146 (110 Stat. 1372) establishes
a condition for the receipt of grants under part B. The condition
relates to notification of spouses of HIV-infected patients.
\2\ See footnote at the beginning of part A.
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SEC. 2612. [300FF-22] GENERAL USE OF GRANTS.
(a) In General.--A State may use amounts provided under
grants made under section 2611 for--
(1) core medical services described in subsection
(b);
(2) support services described in subsection (c);
and
(3) administrative expenses described in section
2618(b)(3).
(b) Required Funding for Core Medical Services.--
(1) In general.--With respect to a grant under
section 2611 for a State for a grant year, the State
shall, of the portion of the grant remaining after
reserving amounts for purposes of subparagraphs (A) and
(E)(ii)(I) of section 2618(b)(3), use not less than 75
percent to provide core medical services that are
needed in the State for individuals with HIV/AIDS who
are identified and eligible under this title (including
services regarding the co-occurring conditions of the
individuals).
(2) Waiver.--
(A) In general.--The Secretary shall waive
the application of paragraph (1) with respect
to a State for a grant year if the Secretary
determines that, within the State--
(i) there are no waiting lists for
AIDS Drug Assistance Program services
under section 2616; and
(ii) core medical services are
available to all individuals with HIV/
AIDS identified and eligible under this
title.
(B) Notification of waiver status.--When
informing a State that a grant under section
2611 is being made to the State for a fiscal
year, the Secretary shall inform the State
whether a waiver under subparagraph (A) is in
effect for the fiscal year.
(3) Core medical services.--For purposes of this
subsection, the term ``core medical services'', with
respect to an individual infected with HIV/AIDS
(including the co-occurring conditions of the
individual) means the following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments
in accordance with section 2616.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (d).
(F) Health insurance premium and cost
sharing assistance for low-income individuals
in accordance with section 2615.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 2614(c).
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(c) Support Services.--
(1) In general.--For purposes of this subsection,
the term ``support services'' means services, subject
to the approval of the Secretary, that are needed for
individuals with HIV/AIDS to achieve their medical
outcomes (such as respite care for persons caring for
individuals with HIV/AIDS, outreach services, medical
transportation, linguistic services, and referrals for
health care and support services).
(2) Definition of medical outcomes.--In this
subsection, the term ``medical outcomes'' means those
outcomes affecting the HIV-related clinical status of
an individual with HIV/AIDS.
(d) Early Intervention Services.--
(1) In general.--For purposes of this section, the
term ``early intervention services'' means HIV/AIDS
early intervention services described in section
2651(e), with follow-up referral provided for the
purpose of facilitating the access of individuals
receiving the services to HIV-related health services.
The entities through which such services may be
provided under the grant include public health
departments, emergency rooms, substance abuse and
mental health treatment programs, detoxification
centers, detention facilities, clinics regarding
sexually transmitted diseases, homeless shelters, HIV/
AIDS counseling and testing sites, health care points
of entry specified by States, federally qualified
health centers, and entities described in section
2652(a) that constitute a point of access to services
by maintaining referral relationships.
(2) Conditions.--With respect to an entity that
proposes to provide early intervention services under
paragraph (1), such paragraph shall apply only if the
entity demonstrates to the satisfaction of the chief
elected official for the State involved that--
(A) Federal, State, or local funds are
otherwise inadequate for the early intervention
services the entity proposes to provide; and
(B) the entity will expend funds pursuant
to such subparagraph to supplement and not
supplant other funds available to the entity
for the provision of early intervention
services for the fiscal year involved.
(e) Priority for Women, Infants, Children, and Youth.--
(1) In general.--For the purpose of providing
health and support services to infants, children,
youth, and women with HIV/AIDS, including treatment
measures to prevent the perinatal transmission of HIV,
a State shall for each of such populations in the
eligible area use, from the grants made for the area
under section 2601(a) for a fiscal year, not less than
the percentage constituted by the ratio of the
population involved (infants, children, youth, or women
in such area) with HIV/AIDS to the general population
in such area of individuals with HIV/AIDS.
(2) Waiver.--With respect to the population
involved, the Secretary may provide to a State a waiver
of the requirement of paragraph (1) if such State
demonstrates to the satisfaction of the Secretary that
the population is receiving HIV-related health services
through the State medicaid program under title XIX of
the Social Security Act, the State children's health
insurance program under title XXI of such Act, or other
Federal or State programs.
(f) Construction.--A State may not use amounts received
under a grant awarded under section 2611 to purchase or improve
land, or to purchase, construct, or permanently improve (other
than minor remodeling) any building or other facility, or to
make cash payments to intended recipients of services.
SEC. 2613. [300FF-23] GRANTS TO ESTABLISH HIV CARE CONSORTIA.
(a) Consortia.--A State may, subject to subsection (f), use
amounts provided under a grant awarded under section 2611 to
provide assistance under section 2612(a) to an entity that--
(1) is an association of one or more public, and
one or more nonprofit private, (or private for-profit
providers or organizations if such entities are the
only available providers of quality HIV care in the
area) health care and support service providers and
community based organizations operating within areas
determined by the State to be most affected by HIV/
AIDS; and
(2) agrees to use such assistance for the planning,
development and delivery, through the direct provision
of services or through entering into agreements with
other entities for the provision of such services, of
comprehensive outpatient health and support services
for individuals with HIV disease, that may include--
(A) essential health services such as case
management services, medical, nursing,
substance abuse treatment, mental health
treatment, and dental care, diagnostics,
monitoring, prophylactic treatment for
opportunistic infections, treatment education
to take place in the context of health care
delivery, and medical follow-up services,
mental health, developmental, and
rehabilitation services, home health and
hospice care; and
(B) essential support services such as
transportation services, attendant care,
homemaker services, day or respite care,
benefits advocacy, advocacy services provided
through public and nonprofit private entities,
and services that are incidental to the
provision of health care services for
individuals with HIV/AIDS including nutrition
services, housing referral services, and child
welfare and family services (including foster
care and adoption services).
An entity or entities of the type described in this subsection
shall hereinafter be referred to in this title as a
``consortium'' or ``consortia''.
(b) Assurances.--
(1) Requirement.--To receive assistance from a
State under subsection (a), an applicant consortium
shall provide the State with assurances that--
(A) within any locality in which such
consortium is to operate, the populations and
subpopulations of individuals and families with
HIV/AIDS have been identified by the
consortium, particularly those experiencing
disparities in access and services and those
who reside in historically underserved
communities;
(B) the service plan established under
subsection (c)(2) by such consortium is
consistent with the comprehensive plan under
section 2617(b)(4) and addresses the special
care and service needs of the populations and
subpopulations identified under subparagraph
(A); and
(C) except as provided in paragraph (2),
the consortium will be a single coordinating
entity that will integrate the delivery of
services among the populations and
subpopulations identified under subparagraph
(A).
(2) Exception.--Subparagraph (C) of paragraph (1)
shall not apply to any applicant consortium that the
State determines will operate in a community or
locality in which it has been demonstrated by the
applicant consortium that--
(A) subpopulations exist within the
community to be served that have unique service
requirements; and
(B) such unique service requirements cannot
be adequately and efficiently addressed by a
single consortium serving the entire community
or locality.
(c) Application.--
(1) In general.--To receive assistance from the
State under subsection (a), a consortium shall prepare
and submit to the State, an application that--
(A) demonstrates that the consortium
includes agencies and community-based
organizations--
(i) with a record of service to
populations and subpopulations with
HIV/AIDS requiring care within the
community to be served; and
(ii) that are representative of
populations and subpopulations
reflecting the local incidence of HIV
and that are located in areas in which
such populations reside;
(B) demonstrates that the consortium has
carried out an assessment of service needs
within the geographic area to be served and,
after consultation with the entities described
in paragraph (2), has established a plan to
ensure the delivery of services to meet such
identified needs that shall include--
(i) assurances that service needs
will be addressed through the
coordination and expansion of existing
programs before new programs are
created;
(ii) assurances that, in
metropolitan areas, the geographic area
to be served by the consortium
corresponds to the geographic
boundaries of local health and support
services delivery systems to the extent
practicable;
(iii) assurances that, in the case
of services for individuals residing in
rural areas, the applicant consortium
shall deliver case management services
that link available community support
services to appropriate specialized
medical services; and
(iv) assurances that the assessment
of service needs and the planning of
the delivery of services will include
participation by individuals with HIV/
AIDS;
(C) demonstrates that adequate planning has
occurred to meet the special needs of families
with HIV/AIDS, including family centered and
youth centered care;
(D) demonstrates that the consortium has
created a mechanism to evaluate periodically--
(i) the success of the consortium
in responding to identified needs; and
(ii) the cost-effectiveness of the
mechanisms employed by the consortium
to deliver comprehensive care;
(E) demonstrates that the consortium will
report to the State the results of the
evaluations described in subparagraph (D) and
shall make available to the State or the
Secretary, on request, such data and
information on the program methodology that may
be required to perform an independent
evaluation; and
(F) demonstrates that adequate planning
occurred to address disparities in access and
services and historically underserved
communities.
(2) Consultation.--In establishing the plan
required under paragraph (1)(B), the consortium shall
consult with--
(A)(i) the public health agency that
provides or supports ambulatory and outpatient
HIV-related health care services within the
geographic area to be served; or
(ii) in the case of a public health agency
that does not directly provide such HIV-related
health care services such agency shall consult
with an entity or entities that directly
provide ambulatory and outpatient HIV-related
health care services within the geographic area
to be served;
(B) not less than one community-based
organization that is organized solely for the
purpose of providing HIV-related support
services to individuals with HIV/AIDS;
(C) grantees under section 2671, or, if
none are operating in the area, representatives
in the area of organizations with a history of
serving children, youth, women, and families
living with HIV; and
(D) the types of entities described in
section 2602(b)(2).
The organization to be consulted under subparagraph (B)
shall be at the discretion of the applicant consortium.
(d) Definition.--As used in section 2611, the term ``family
centered care'' means the system of services described in this
section that is targeted specifically to the special needs of
infants, children, women, and families. Family centered care
shall be based on a partnership between parents, professionals,
and the community designed to ensure an integrated,
coordinated, culturally sensitive, and community-based
continuum of care for children, women, and families with HIV/
AIDS.
(e) Priority.--In providing assistance under subsection
(a), the State shall, among applicants that meet the
requirements of this section, give priority--
(1) first to consortia that are receiving
assistance from the Health Resources and Services
Administration for adult and pediatric HIV-related care
demonstration projects; and then
(2) to any other existing HIV care consortia.
(f) Allocation of Funds; Treatment as Support Services.--
For purposes of the requirement of section 2612(b)(1),
expenditures of grants under section 2611 for or through
consortia under this section are deemed to be support services,
not core medical services. The preceding sentence may not be
construed as having any legal effect on the provisions of
subsection (a) that relate to authorized expenditures of the
grant.
SEC. 2614. [300FF-24] GRANTS FOR HOME- AND COMMUNITY-BASED CARE.
(a) Uses.--A State may use amounts provided under a grant
awarded under section 2611 to make grants under section
2612(b)(3)(J) to entities to--
(1) provide home- and community-based health
services for individuals with HIV/AIDS pursuant to
written plans of care prepared by a case management
team, that shall include appropriate health care
professionals, in such State for providing such
services to such individuals;
(2) provide outreach services to individuals with
HIV/AIDS, including those individuals in rural areas;
and
(3) provide for the coordination of the provision
of services under this section with the provision of
HIV-related health services, including specialty care
and vaccinations for hepatitis co-infection, provided
by public and private entities.
(b) Priority.--In awarding grants under subsection (a), a
State shall give priority to entities that provide assurances
to the State that--
(1) such entities will participate in HIV care
consortia if such consortia exist within the State; and
(2) such entities will utilize amounts provided
under such grants for the provision of home- and
community-based services to low-income individuals with
HIV/AIDS.
(c) Definition.--As used in section 2611, the term ``home-
and community-based health services''--
(1) means, with respect to an individual with HIV/
AIDS, skilled health services furnished to the
individual in the individual's home pursuant to a
written plan of care established by a case management
team, that shall include appropriate health care
professionals, for the provision of such services and
items described in paragraph (2);
(2) includes--
(A) durable medical equipment;
(B) home health aide services and personal
care services furnished in the home of the
individual;
(C) day treatment or other partial
hospitalization services;
(D) home intravenous and aerosolized drug
therapy (including prescription drugs
administered as part of such therapy);
(E) routine diagnostic testing administered
in the home of the individual; and
(F) appropriate mental health,
developmental, and rehabilitation services; and
(3) does not include--
(A) inpatient hospital services; and
(B) nursing home and other long term care
facilities.
SEC. 2615. [300FF-25] CONTINUUM OF HEALTH INSURANCE COVERAGE.
(a) In General.--A State may use amounts received under a
grant awarded under section 2611 to establish a program of
financial assistance under section 2612(b)(3)(F) to assist
eligible low-income individuals with HIV/AIDS in--
(1) maintaining a continuity of health insurance;
or
(2) receiving medical benefits under a health
insurance program, including risk-pools.
(b) Limitations.--Assistance shall not be utilized under
subsection (a)--
(1) to pay any costs associated with the creation,
capitalization, or administration of a liability risk
pool (other than those costs paid on behalf of
individuals as part of premium contributions to
existing liability risk pools); and
(2) to pay any amount expended by a State under
title XIX of the Social Security Act.
SEC. 2616. [300FF-26] PROVISION OF TREATMENTS.
(a) In General.--A State shall use a portion of the amounts
provided under a grant awarded under section 2611 to establish
a program under section 2612(b)(3)(B) to provide therapeutics
to treat HIV/AIDS or prevent the serious deterioration of
health arising from HIV/AIDS in eligible individuals, including
measures for the prevention and treatment of opportunistic
infections.
(b) Eligible Individual.--To be eligible to receive
assistance from a State under this section an individual
shall--
(1) have a medical diagnosis of HIV/AIDS; and
(2) be a low-income individual, as defined by the
State.
(c) State Duties.--In carrying out this section the State
shall--
(1) ensure that the therapeutics included on the
list of classes of core antiretroviral therapeutics
established by the Secretary under subsection (e) are,
at a minimum, the treatments provided by the State
pursuant to this section;
(2) provide assistance for the purchase of
treatments determined to be eligible under paragraph
(1), and the provision of such ancillary devices that
are essential to administer such treatments;
(3) provide outreach to individuals with HIV/AIDS,
and as appropriate to the families of such individuals;
(4) facilitate access to treatments for such
individuals;
(5) document the progress made in making
therapeutics described in subsection (a) available to
individuals eligible for assistance under this section;
and
(6) encourage, support, and enhance adherence to
and compliance with treatment regimens, including
related medical monitoring.
Of the amount reserved by a State for a fiscal year for use
under this section, the State may not use more than 5 percent
to carry out services under paragraph (6), except that the
percentage applicable with respect to such paragraph is 10
percent if the State demonstrates to the Secretary that such
additional services are essential and in no way diminish access
to the therapeutics described in subsection (a).
(d) Duties of the Secretary.--In carrying out this section,
the Secretary shall review the current status of State drug
reimbursement programs established under section 2612(2) and
assess barriers to the expanded availability of the treatments
described in subsection (a). The Secretary shall also examine
the extent to which States coordinate with other grantees under
this title to reduce barriers to the expanded availability of
the treatments described in subsection (a).
(e) List of Classes of Core Antiretroviral Therapeutics.--
For purposes of subsection (c)(1), the Secretary shall develop
and maintain a list of classes of core antiretroviral
therapeutics, which list shall be based on the therapeutics
included in the guidelines of the Secretary known as the
Clinical Practice Guidelines for Use of HIV/AIDS Drugs,
relating to drugs needed to manage symptoms associated with
HIV. The preceding sentence does not affect the authority of
the Secretary to modify such Guidelines.
(f) Use of Health Insurance and Plans.--
(1) In general.--In carrying out subsection (a), a
State may expend a grant under section 2611 to provide
the therapeutics described in such subsection by paying
on behalf of individuals with HIV/AIDS the costs of
purchasing or maintaining health insurance or plans
whose coverage includes a full range of such
therapeutics and appropriate primary care services.
(2) Limitation.--The authority established in
paragraph (1) applies only to the extent that, for the
fiscal year involved, the costs of the health insurance
or plans to be purchased or maintained under such
paragraph do not exceed the costs of otherwise
providing therapeutics described in subsection (a).
(g) Drug Rebate Program.--A State shall ensure that any
drug rebates received on drugs purchased from funds provided
pursuant to this section are applied to activities supported
under this subpart, with priority given to activities described
under this section.
SEC. 2617. [300FF-27] STATE APPLICATION.
(a) In General.--The Secretary shall not make a grant to a
State under section 2611 for a fiscal year unless the State
prepares and submits, to the Secretary, an application at such
time, in such form, and containing such agreements, assurances,
and information as the Secretary determines to be necessary to
carry out section 2611.
(b) Description of Intended Uses and Agreements.--The
application submitted under subsection (a) shall contain--
(1) a detailed description of the HIV-related
services provided in the State to individuals and
families with HIV/AIDS during the year preceding the
year for which the grant is requested, and the number
of individuals and families receiving such services,
that shall include--
(A) a description of the types of programs
operated or funded by the State for the
provision of HIV-related services during the
year preceding the year for which the grant is
requested and the methods utilized by the State
to finance such programs;
(B) an accounting of the amount of funds
that the State has expended for such services
and programs during the year preceding the year
for which the grant is requested; and
(C) information concerning--
(i) the number of individuals to be
served with assistance provided under
the grant;
(ii) demographic data on the
population of the individuals to be
served;
(iii) the average cost of providing
each category of HIV-related health
services and the extent to which such
cost is paid by third-party payors; and
(iv) the aggregate amounts expended
for each such category of services;
(2) a determination of the size and demographics of
the population of individuals with HIV/AIDS in the
State;
(3) a determination of the needs of such
population, with particular attention to--
(A) individuals with HIV/AIDS who know
their HIV status and are not receiving HIV-
related services; and
(B) disparities in access and services
among affected subpopulations and historically
underserved communities;
(4) the designation of a lead State agency that
shall--
(A) administer all assistance received
under section 2611;
(B) conduct the needs assessment and
prepare the State plan under paragraph (3);
(C) prepare all applications for assistance
under section 2611;
(D) receive notices with respect to
programs under this title;
(E) every 2 years, collect and submit to
the Secretary all audits, consistent with
Office of Management and Budget circular A133,
from grantees within the State, including
audits regarding funds expended in accordance
with section 2611; and
(F) carry out any other duties determined
appropriate by the Secretary to facilitate the
coordination of programs under this title.
(5) a comprehensive plan that describes the
organization and delivery of HIV health care and
support services to be funded with assistance received
under section 2611 that shall include a description of
the purposes for which the State intends to use such
assistance, and that--
(A) \1\ establishes priorities for the
allocation of funds within the State based on--
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\1\The placement of subparagraphs (A) through (C) is according to
the probable intent of the Congress. Section 205(a)(3) of Public Law
106-345 (114 Stat. 1332, 1333) amended paragraph (4) by redesignating
subparagraphs (A) through (C) as subparagraphs (D) through (F), and
then instructed that new subparagraphs (A) through (C) be inserted
before ``subparagraph (C)''. The amendment probably should have
instructed that the new subparagraphs be inserted before subparagraph
(D), as redesignated.
---------------------------------------------------------------------------
(i) size and demographics of the
population of individuals with HIV/AIDS
(as determined under paragraph (2)) and
the needs of such population (as
determined under paragraph (3));
(ii) availability of other
governmental and non-governmental
resources, including the State medicaid
plan under title XIX of the Social
Security Act and the State Children's
Health Insurance Program under title
XXI of such Act to cover health care
costs of eligible individuals and
families with HIV/AIDS;
(iii) capacity development needs
resulting from disparities in the
availability of HIV-related services in
historically underserved communities
and rural communities; and
(iv) the efficiency of the
administrative mechanism of the State
for rapidly allocating funds to the
areas of greatest need within the
State;
(B) includes a strategy for identifying
individuals who know their HIV status and are
not receiving such services and for informing
the individuals of and enabling the individuals
to utilize the services, giving particular
attention to eliminating disparities in access
and services among affected subpopulations and
historically underserved communities, and
including discrete goals, a timetable, and an
appropriate allocation of funds;
(C) includes a strategy to coordinate the
provision of such services with programs for
HIV prevention (including outreach and early
intervention) and for the prevention and
treatment of substance abuse (including
programs that provide comprehensive treatment
services for such abuse);
(D) describes the services and activities
to be provided and an explanation of the manner
in which the elements of the program to be
implemented by the State with such assistance
will maximize the quality of health and support
services available to individuals with HIV/AIDS
throughout the State;
(E) provides a description of the manner in
which services funded with assistance provided
under section 2611 will be coordinated with
other available related services for
individuals with HIV/AIDS;
(F) provides a description of how the
allocation and utilization of resources are
consistent with the statewide coordinated
statement of need (including traditionally
underserved populations and subpopulations)
developed in partnership with other grantees in
the State that receive funding under this
title; and
(G) includes key outcomes to be measured by
all entities in the State receiving assistance
under this title; and
(6) an assurance that the public health agency
administering the grant for the State will periodically
convene a meeting of individuals with HIV/AIDS, members
of a Federally recognized Indian tribe as represented
in the State, representatives of grantees under each
part under this title, providers, and public agency
representatives for the purpose of developing a
statewide coordinated statement of need;
(7) an assurance by the State that--
(A) the public health agency that is
administering the grant for the State engages
in a public advisory planning process,
including public hearings, that includes the
participants under paragraph (6), and the types
of entities described in section 2602(b)(2), in
developing the comprehensive plan under
paragraph (5) and commenting on the
implementation of such plan;
(B) the State will--
(i) to the maximum extent
practicable, ensure that HIV-related
health care and support services
delivered pursuant to a program
established with assistance provided
under section 2611 will be provided
without regard to the ability of the
individual to pay for such services and
without regard to the current or past
health condition of the individual with
HIV/AIDS;
(ii) ensure that such services will
be provided in a setting that is
accessible to low-income individuals
with HIV/AIDS;
(iii) provide outreach to low-
income individuals with HIV/AIDS to
inform such individuals of the services
available under section 2611; and
(iv) in the case of a State that
intends to use amounts provided under
the grant for purposes described in
2615 \1\, submit a plan to the
Secretary that demonstrates that the
State has established a program that
assures that--
---------------------------------------------------------------------------
\1\ The word ``section'' probably should appear before ``2615''.
Section 12(c)(3) of Public Law 104-146 (110 Stat. 1373) provides that
subsection (b)(3)(B)(iv) is amended by inserting ``section'' before
``2615'', but the amendment cannot be executed because the term
``2615'' does not appear in paragraph (3)(B)(iv). The term formerly did
appear in such paragraph, but former paragraph (3) was redesignated as
paragraph (4) by section 3(c)(4)(B) of such Public Law (110 Stat.
1355).
---------------------------------------------------------------------------
(I) such amounts will be
targeted to individuals who
would not otherwise be able to
afford health insurance
coverage; and
(II) income, asset, and
medical expense criteria will
be established and applied by
the State to identify those
individuals who qualify for
assistance under such program,
and information concerning such
criteria shall be made
available to the public;
(C) the State will provide for periodic
independent peer review to assess the quality
and appropriateness of health and support
services provided by entities that receive
funds from the State under section 2611;
(D) the State will permit and cooperate
with any Federal investigations undertaken
regarding programs conducted under section
2611;
(E) the State will maintain HIV-related
activities at a level that is equal to not less
than the level of such expenditures by the
State for the 1-year period preceding the
fiscal year for which the State is applying to
receive a grant under section 2611;
(F) the State will ensure that grant funds
are not utilized to make payments for any item
or service to the extent that payment has been
made, or can reasonably be expected to be made,
with respect to that item or service--
(i) under any State compensation
program, under an insurance policy, or
under any Federal or State health
benefits program; or
(ii) by an entity that provides
health services on a prepaid basis
(except for a program administered by
or providing the services of the Indian
Health Service); and
(G) entities within areas in which
activities under the grant are carried out will
maintain appropriate relationships with
entities in the area served that constitute key
points of access to the health care system for
individuals with HIV/AIDS (including emergency
rooms, substance abuse treatment programs,
detoxification centers, adult and juvenile
detention facilities, sexually transmitted
disease clinics, HIV counseling and testing
sites, mental health programs, and homeless
shelters), and other entities under section
2612(c) and 2652(a), for the purpose of
facilitating early intervention for individuals
newly diagnosed with HIV/AIDS and individuals
knowledgeable of their HIV status but not in
care; and
(8) a comprehensive plan--
(A) containing an identification of
individuals with HIV/AIDS as described in
clauses (i) through (iii) of section
2603(b)(2)(A) and the strategy required under
section 2602(b)(4)(D)(iv);
(B) describing the estimated number of
individuals within the State with HIV/AIDS who
do not know their status;
(C) describing activities undertaken by the
State to find the individuals described in
subparagraph (A) and to make such individuals
aware of their status;
(D) describing the manner in which the
State will provide undiagnosed individuals who
are made aware of their status with access to
medical treatment for their HIV/AIDS; and
(E) describing efforts to remove legal
barriers, including State laws and regulations,
to routine testing.
(c) Requirements Regarding Imposition of Charges for
Services.--
(1) In General.--The Secretary may not make a grant
under section 2611 to a State unless the State provides
assurances that in the provision of services with
assistance provided under the grant--
(A) in the case of individuals with an
income less than or equal to 100 percent of the
official poverty line, the provider will not
impose charges on any such individual for the
provision of services under the grant;
(B) in the case of individuals with an
income greater than 100 percent of the official
poverty line, the provider--
(i) will impose charges on each
such individual for the provision of
such services; and
(ii) will impose charges according
to a schedule of charges that is made
available to the public;
(C) in the case of individuals with an
income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an amount
exceeding 5 percent of the annual gross income
of the individual involved;
(D) in the case of individuals with an
income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the provider will not, for
any calendar year, impose charges in an amount
exceeding 7 percent of the annual gross income
of the individual involved; and
(E) in the case of individuals with an
income greater than 300 percent of the official
poverty line, the provider will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income
of the individual involved.
(2) Assessment of charge.--With respect to
compliance with the assurance made under paragraph (1),
a grantee under section 2611 may, in the case of
individuals subject to a charge for purposes of such
paragraph--
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules regarding
limitation on the maximum amount of charges;
and
(B) take into consideration the medical
expenses of individuals in assessing the amount
of the charge, subject to such provisions.
(3) Applicability of limitation on amount of
charge.--The Secretary may not make a grant under
section 2611 unless the applicant of the grant agrees
that the limitations established in subparagraphs (C),
(D), and (E) of paragraph (1) regarding the imposition
of charges for services applies to the annual aggregate
of charges imposed for such services, without regard to
whether they are characterized as enrollment fees,
premiums, deductibles, cost sharing, copayments,
coinsurance, or other charges.
(4) Waiver.--
(A) In general.--The State shall waive the
requirements established in paragraphs (1)
through (3) in the case of an entity that does
not, in providing health care services, impose
a charge or accept reimbursement from any
third-party payor, including reimbursement
under any insurance policy or under any Federal
or State health benefits program.
(B) Determination.--A determination by the
State of whether an entity referred to in
subparagraph (A) meets the criteria for a
waiver under such subparagraph shall be made
without regard to whether the entity accepts
voluntary donations regarding the provision of
services to the public.
(d) Requirement of Matching Funds Regarding State
Allotments.--
(1) In general.--In the case of any State to which
the criterion described in paragraph (3) applies, the
Secretary may not make a grant under section 2611
unless the State agrees that, with respect to the costs
to be incurred by the State in carrying out the program
for which the grant was awarded, the State will,
subject to subsection (b)(2), make available (directly
or through donations from public or private entities)
non-Federal contributions toward such costs in an
amount equal to--
(A) for the first fiscal year of payments
under the grant, not less than 16\2/3\ percent
of such costs ($1 for each $5 of Federal funds
provided in the grant);
(B) for any second fiscal year of such
payments, not less than 20 percent of such
costs ($1 for each $4 of Federal funds provided
in the grant);
(C) for any third fiscal year of such
payments, not less than 25 percent of such
costs ($1 for each $3 of Federal funds provided
in the grant);
(D) for any fourth fiscal year of such
payments, not less than 33\1/3\ percent of such
costs ($1 for each $2 of Federal funds provided
in the grant); and
(E) for any subsequent fiscal year of such
payments, not less than 33\1/3\ percent of such
costs ($1 for each $2 of Federal funds provided
in the grant).
(2) Determination of amount of non-federal
contribution.--
(A) In general.--Non-Federal contributions
required in paragraph (1) may be in cash or in
kind, fairly evaluated, including plant,
equipment, or services. Amounts provided by the
Federal Government, and any portion of any
service subsidized by the Federal Government,
may not be included in determining the amount
of such non-Federal contributions.
(B) Inclusion of certain amounts.--
(i) In making a determination of
the amount of non-Federal contributions
made by a State for purposes of
paragraph (1), the Secretary shall,
subject to clause (ii), include any
non-Federal contributions provided by
the State for HIV-related services,
without regard to whether the
contributions are made for programs
established pursuant to this title;
(ii) In making a determination for
purposes of clause (i), the Secretary
may not include any non-Federal
contributions provided by the State as
a condition of receiving Federal funds
under any program under this title
(except for the program established in
section 2611) or under other provisions
of law.
(3) Applicability of requirement.--
(A) Number of cases.--A State referred to
in paragraph (1) is any State for which the
number of cases of HIV/AIDS reported to and
confirmed by the Director of the Centers for
Disease Control and Prevention for the period
described in subparagraph (B) constitutes in
excess of 1 percent of the aggregate number of
such cases reported to and confirmed by the
Director for such period for the United States.
(B) Period of time.--The period referred to
in subparagraph (A) is the 2-year period
preceding the fiscal year for which the State
involved is applying to receive a grant under
subsection (a).
(C) Puerto Rico.--For purposes of paragraph
(1), the number of cases of HIV/AIDS reported
and confirmed for the Commonwealth of Puerto
Rico for any fiscal year shall be deemed to be
less than 1 percent.
(4) Diminished state contribution.--With respect to
a State that does not make available the entire amount
of the non-Federal contribution referred to in
paragraph (1), the State shall continue to be eligible
to receive Federal funds under a grant under section
2611, except that the Secretary in providing Federal
funds under the grant shall provide such funds (in
accordance with the ratios prescribed in paragraph (1))
only with respect to the amount of funds contributed by
such State.
SEC. 2618. [300FF-28] DISTRIBUTION OF FUNDS.
(a) Amount of Grant to State.--
(1) Minimum allotment.--Subject to the extent of
amounts made available under section 2623, the amount
of a grant to be made under section 2611 for--
(A) each of the 50 States, the District of
Columbia, Guam, and the Virgin Islands
(referred to in this paragraph as a ``covered
State'') for a fiscal year shall be the greater
of--
(i)(I) with respect to a covered
State that has less than 90 living
cases of AIDS, as determined under
paragraph (2)(D), $200,000; or
(II) with respect to a covered
State that has 90 or more living cases
of AIDS, as determined under paragraph
(2)(D), $500,000; and
(ii) an amount determined under
paragraph (2) and then, as applicable,
increased under paragraph (2)(H); and
(B) each territory other than Guam and the
Virgin Islands shall be the greater of $50,000
or an amount determined under paragraph (2).
(2) Determination.--
(A) Formula.--For purposes of paragraph
(1), the amount referred to in this paragraph
for a State (including a territory) for a
fiscal year is, subject to subparagraphs (E)
and (F)--
(i) an amount equal to the amount
made available under section 2623 for
the fiscal year involved for grants
pursuant to paragraph (1), subject to
subparagraph (F); and
(ii) the percentage constituted by
the sum of--
(I) the product of 0.75 and
the ratio of the State
distribution factor for the
State or territory (as
determined under subsection
(B)) to the sum of the
respective State distribution
factors for all States or
territories;
(II) the product of .20 and
the ratio of the non-EMA
distribution factor for the
State or territory (as
determined under subparagraph
(C)) to the sum of the
respective non-EMA distribution
factors for all States or
territories; and
(III) if the State does not
for such fiscal year contain
any area that is an eligible
area under subpart I of part A
or any area that is a
transitional area under section
2609 (referred to in this
subclause as a ``no-EMA
State''), the product of 0.05
and the ratio of the number of
cases that applies for the
State under subparagraph (D) to
the sum of the respective
numbers of cases that so apply
for all no-EMA States.
(B) State distribution factor.--For
purposes of subparagraph (A)(ii)(I), the term
``State distribution factor'' means an amount
equal to the number of living cases of HIV/AIDS
in the State involved, as determined under
subparagraph (D).
(C) Non-ema distribution factor.--For
purposes of subparagraph (A)(ii)(II), the term
``non-ema distribution factor'' means an amount
equal to the sum of--
(i) the number of living cases of
HIV/AIDS in the State involved, as
determined under subparagraph (D); less
(ii) a number equal to the sum of--
(I) the total number of
living cases of HIV/AIDS that
are within areas in such State
that are eligible areas under
subpart I of part A for the
fiscal year involved, which
individual number for an area
is the number that applies
under section 2601 for the area
for such fiscal year; and
(II) the total number of
such cases that are within
areas in such State that are
transitional areas under
section 2609 for such fiscal
year, which individual number
for an area is the number that
applies under such section for
the fiscal year.
(D) Living cases of hiv/aids.--
(i) Requirement of names-based
reporting.--Except as provided in
clause (ii), the number determined
under this subparagraph for a State for
a fiscal year for purposes of
subparagraph (B) is the number of
living names-based cases of HIV/AIDS in
the State that, as of December 31 of
the most recent calendar year for which
such data is available, have been
reported to and confirmed by the
Director of the Centers for Disease
Control and Prevention.
(ii) Transition period; exemption
regarding non-aids cases.--For each of
the fiscal years 2007 through 2012, a
State is, subject to clauses (iii)
through (v), exempt from the
requirement under clause (i) that
living non-AIDS names-based cases of
HIV be reported unless--
(I) a system was in
operation as of December 31,
2005, that provides
sufficiently accurate and
reliable names-based reporting
of such cases throughout the
State, subject to clause (vii);
or
(II) no later than the
beginning of fiscal year 2008
or a subsequent fiscal year
through fiscal year 2012, the
Secretary, after consultation
with the chief executive of the
State, determines that a system
has become operational in the
State that provides
sufficiently accurate and
reliable names-based reporting
of such cases throughout the
State.
(iii) Requirements for exemption
for fiscal year 2007.--For fiscal year
2007, an exemption under clause (ii)
for a State applies only if, by October
1, 2006--
(I)(aa) the State had
submitted to the Secretary a
plan for making the transition
to sufficiently accurate and
reliable names-based reporting
of living non-AIDS cases of
HIV; or
(bb) all statutory changes
necessary to provide for
sufficiently accurate and
reliable reporting of such
cases had been made; and
(II) the State had agreed
that, by April 1, 2008, the
State will begin accurate and
reliable names-based reporting
of such cases, except that such
agreement is not required to
provide that, as of such date,
the system for such reporting
be fully sufficient with
respect to accuracy and
reliability throughout the
area.
(iv) Requirement for exemption as
of fiscal year 2008.--For each of the
fiscal years 2008 through 2012, an
exemption under clause (ii) for a State
applies only if, as of April 1, 2008,
the State is substantially in
compliance with the agreement under
clause (iii)(II).
(v) Progress toward names-based
reporting.--For fiscal year 2009 or a
subsequent fiscal year, the Secretary
may terminate an exemption under clause
(ii) for a State if the State submitted
a plan under clause (iii)(I)(aa) and
the Secretary determines that the State
is not substantially following the
plan.
(vi) Counting of cases in areas
with exemptions.--
(I) In general.--With
respect to a State that is
under a reporting system for
living non-AIDS cases of HIV
that is not names-based
(referred to in this
subparagraph as ``code-based
reporting''), the Secretary
shall, for purposes of this
subparagraph, modify the number
of such cases reported for the
State in order to adjust for
duplicative reporting in and
among systems that use code-
based reporting.
(II) Adjustment rate.--The
adjustment rate under subclause
(I) for a State shall be a
reduction of 5 percent for
fiscal years before fiscal year
2012 (and 6 percent for fiscal
year 2012) in the number of
living non-AIDS cases of HIV
reported for the State.
(III) Increased adjustment
for certain states previously
using code-based reporting.--
For purposes of this
subparagraph for each of fiscal
years 2010 through 2012, the
Secretary shall deem the
applicable number of living
cases of HIV/AIDS in a State
that were reported to and
confirmed by the Centers for
Disease Control and Prevention
to be 3 percent higher than the
actual number if--
(aa) there is an
area in such State that
satisfies all of the
conditions described in
items (aa) through (cc)
of section
2603(a)(3)(C)(vi)(III);
or
(bb)(AA) fiscal
year 2007 was the first
year in which the count
of living non-AIDS
cases of HIV in such
area, for purposes of
this part, was based on
a names-based reporting
system; and
(BB) the amount of
funding that such State
received under this
part for fiscal year
2007 was less than 70
percent of the amount
of funding that such
State received under
such part for fiscal
year 2006.
(vii) List of states meeting
standard regarding december 31, 2005.--
(I) In general.--If a State
is specified in subclause (II),
the State shall be considered
to meet the standard described
in clause (ii)(I). No other
State may be considered to meet
such standard.
(II) Relevant states.--For
purposes of subclause (I), the
States specified in this
subclause are the following:
Alaska, Alabama, Arkansas,
Arizona, Colorado, Florida,
Indiana, Iowa, Idaho, Kansas,
Louisiana, Michigan, Minnesota,
Missouri, Mississippi, North
Carolina, North Dakota,
Nebraska, New Jersey, New
Mexico, New York, Nevada, Ohio,
Oklahoma, South Carolina, South
Dakota, Tennessee, Texas, Utah,
Virginia, Wisconsin, West
Virginia, Wyoming, Guam, and
the Virgin Islands.
(viii) Rules of construction
regarding acceptance of reports.--
(I) Cases of aids.--With
respect to a State that is
subject to the requirement
under clause (i) and is not in
compliance with the requirement
for names-based reporting of
living non-AIDS cases of HIV,
the Secretary shall,
notwithstanding such
noncompliance, accept reports
of living cases of AIDS that
are in accordance with such
clause.
(II) Applicability of
exemption requirements.--The
provisions of clauses (ii)
through (vii) may not be
construed as having any legal
effect for fiscal year 2013 or
any subsequent fiscal year, and
accordingly, the status of a
State for purposes of such
clauses may not be considered
after fiscal year 2012.
(ix) Program for detecting
inaccurate or fraudulent counting.--The
Secretary shall carry out a program to
monitor the reporting of names-based
cases for purposes of this subparagraph
and to detect instances of inaccurate
reporting, including fraudulent
reporting.
(x) Future fiscal years.--For
fiscal years beginning with fiscal year
2013, determinations under this
paragraph shall be based only on living
names-based cases of HIV/AIDS with
respect to the State involved.
(E) Code-based states; limitation on
increase in grant.--
(i) In general.--For each of the
fiscal years 2007 through 2012, if
code-based reporting (within the
meaning of subparagraph (D)(vi))
applies in a State as of the beginning
of the fiscal year involved, then
notwithstanding any other provision of
this paragraph, the amount of the grant
pursuant to paragraph (1) for the State
may not for the fiscal year involved
exceed by more than 5 percent the
amount of the grant pursuant to this
paragraph for the State for the
preceding fiscal year, except that the
limitation under this clause may not
result in a grant pursuant to paragraph
(1) for a fiscal year that is less than
the minimum amount that applies to the
State under such paragraph for such
fiscal year.
(ii) Use of amounts involved.--For
each of the fiscal years 2007 through
2012, amounts available as a result of
the limitation under clause (i) shall
be made available by the Secretary as
additional amounts for grants pursuant
to section 2620, subject to
subparagraph (H).
(F) \1\ Appropriations for treatment drug
program.--
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\1\ The amendments made by section 203(c) of Public Law 109-415 to
section 2618(a)(2)(G) have been carried out to subparagraph (F), as
redesignated by subsection (b)(4) of such Public Law, in order to
reflect the probable intent of Congress.
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(i) Formula grants.--With respect
to the fiscal year involved, if under
section 2623 an appropriations Act
provides an amount exclusively for
carrying out section 2616, the portion
of such amount allocated to a State
shall be the product of--
(I) \2\ 100 percent of such amount,
less the percentage reserved under
clause (ii)(V); and
---------------------------------------------------------------------------
\2\ Indentation of subclauses (I) and (II) are so in law. See
section 206(e)(1) of Public Law 106-345 (114 Stat. 1336).
---------------------------------------------------------------------------
(II) \2\ the percentage constituted
by the ratio of the State distribution
factor for the State (as determined
under subparagraph (B)) to the sum of
the State distribution factors for all
States;
which product shall then, as
applicable, be increased under
subparagraph (H).
(ii) Supplemental treatment drug
grants.--
(I) In general.--From
amounts made available under
subclause (V), the Secretary
shall award supplemental grants
to States described in
subclause (II) to enable such
States to purchase and
distribute to eligible
individuals under section
2616(b) pharmaceutical
therapeutics described under
subsections (c)(2) and (e) of
such section.
(II) Eligible states.--For
purposes of subclause (I), a
State shall be an eligible
State if the State did not have
unobligated funds subject to
reallocation under section
2618(d) in the previous fiscal
year and, in accordance with
criteria established by the
Secretary, demonstrates a
severe need for a grant under
this clause. For purposes of
determining severe need, the
Secretary shall consider
eligibility standards,
formulary composition, the
number of eligible individuals
to whom a State is unable to
provide therapeutics described
in section 2616(a), and an
unanticipated increase of
eligible individuals with HIV/
AIDS.
(III) State requirements.--
The Secretary may not make a
grant to a State under this
clause unless the State agrees
that the State will make
available (directly or through
donations of public or private
entities) non-Federal
contributions toward the
activities to be carried out
under the grant in an amount
equal to $1 for each $4 of
Federal funds provided in the
grant, except that the
Secretary may waive this
subclause if the State has
otherwise fully complied with
section 2617(d) with respect to
the grant year involved. The
provisions of this subclause
shall apply to States that are
not required to comply with
such section 2617(d).
(IV) Use and
coordination.--Amounts made
available under a grant under
this clause shall only be used
by the State to provide HIV/
AIDS-related medications. The
State shall coordinate the use
of such amounts with the
amounts otherwise provided
under section 2616(a) in order
to maximize drug coverage.
(V) Funding.--For the
purpose of making grants under
this clause, the Secretary
shall each fiscal year reserve
5 percent of the amount
referred to in clause (i) with
respect to section 2616.
(iii) Code-based states; limitation
on increase in formula grant.--The
limitation under subparagraph (E)(i)
applies to grants pursuant to clause
(i) of this subparagraph to the same
extent and in the same manner as such
limitation applies to grants pursuant
to paragraph (1), except that the
reference to minimum grants does not
apply for purposes of this clause.
Amounts available as a result of the
limitation under the preceding sentence
shall be made available by the
Secretary as additional amounts for
grants under clause (ii) of this
subparagraph.
(H) \1\ Increase in formula grants.--
---------------------------------------------------------------------------
\1\ So in law. There is no subparagraph (G).
---------------------------------------------------------------------------
(i) Assurance of amount.--
(I) General rule.--For
fiscal year 2010, the Secretary
shall ensure, subject to
clauses (ii) through (iv), that
the total for a State of the
grant pursuant to paragraph (1)
and the grant pursuant to
subparagraph (F) is not less
than 95 percent of such total
for the State for fiscal year
2009.
(II) Rule of
construction.--With respect to
the application of subclause
(I), the 95 percent requirement
under such subclause shall
apply with respect to each
grant awarded under paragraph
(1) and with respect to each
grant awarded under
subparagraph (F).
(ii) Fiscal years 2011 and 2012.--
For each of the fiscal years 2011 and
2012, the Secretary shall ensure that
the total for a State of the grant
pursuant to paragraph (1) and the grant
pursuant to subparagraph (F) is not
less than 100 percent of such total for
the State for fiscal year 2010.
(iii) Fiscal year 2013.--For fiscal
year 2013, the Secretary shall ensure
that the total for a State of the grant
pursuant to paragraph (1) and the grant
pursuant to subparagraph (F) is not
less than 92.5 percent of such total
for the State for fiscal year 2012.
(iv) Source of funds for
increase.--
(I) In general.--From the
amount reserved under section
2623(b)(2) for a fiscal year,
and from amounts available for
such section pursuant to
subsection (d) of this section,
the Secretary shall make
available such amounts as may
be necessary to comply with
clause (i).
(II) Pro rata reduction.--
If the amounts referred to in
subclause (I) for a fiscal year
are insufficient to fully
comply with clause (i) for the
year, the Secretary, in order
to provide the additional funds
necessary for such compliance,
shall reduce on a pro rata
basis the amount of each grant
pursuant to paragraph (1) for
the fiscal year, other than
grants for States for which
increases under clause (i)
apply and other than States
described in paragraph
(1)(A)(i)(I). A reduction under
the preceding sentence may not
be made in an amount that would
result in the State involved
becoming eligible for such an
increase.
(v) Applicability.--This paragraph
may not be construed as having any
applicability after fiscal year 2013.
(b) Allocation of Assistance by States.--
(1) Allowances.--Prior to allocating assistance
under this subsection, a State shall consider the unmet
needs of those areas that have not received financial
assistance under part A.
(2) Planning and evaluations.--Subject to paragraph
(4) and except as provided in paragraph (5), a State
may not use more than 10 percent of amounts received
under a grant awarded under section 2611 for planning
and evaluation activities.
(3) Administration.--
(A) In general.--Subject to paragraph (4),
and except as provided in paragraph (5), a
State may not use more than 10 percent of
amounts received under a grant awarded under
section 2611 for administration.
(B) Allocations.--In the case of entities
and subcontractors to which a State allocates
amounts received by the State under a grant
under section 2611, the State shall ensure
that, of the aggregate amount so allocated, the
total of the expenditures by such entities for
administrative expenses does not exceed 10
percent (without regard to whether particular
entities expend more than 10 percent for such
expenses).
(C) Administrative activities.--For the
purposes of subparagraph (A), amounts may be
used for administrative activities that include
routine grant administration and monitoring
activities, including a clinical quality
management program under subparagraph (E).
(D) Subcontractor administrative costs.--
For the purposes of this paragraph,
subcontractor administrative activities
include--
(i) usual and recognized overhead,
including established indirect rates
for agencies;
(ii) management oversight of
specific programs funded under this
title; and
(iii) other types of program
support such as quality assurance,
quality control, and related
activities.
(E) Clinical quality management.--
(i) Requirement.--Each State that
receives a grant under section 2611
shall provide for the establishment of
a clinical quality management program
to assess the extent to which HIV
health services provided to patients
under the grant are consistent with the
most recent Public Health Service
guidelines for the treatment of HIV/
AIDS and related opportunistic
infection, and as applicable, to
develop strategies for ensuring that
such services are consistent with the
guidelines for improvement in the
access to and quality of HIV health
services.
(ii) Use of funds.--
(I) In general.--From
amounts received under a grant
awarded under section 2611 for
a fiscal year, a State may use
for activities associated with
the clinical quality management
program required in clause (i)
not to exceed the lesser of--
(aa) 5 percent of
amounts received under
the grant; or
(bb) $3,000,000.
(II) Relation to limitation
on administrative expenses.--
The costs of a clinical quality
management program under clause
(i) may not be considered
administrative expenses for
purposes of the limitation
established in subparagraph
(A).
(4) Limitation on use of funds.--Except as provided
in paragraph (5), a State may not use more than a total
of 15 percent of amounts received under a grant awarded
under section 2611 for the purposes described in
paragraphs (2) and (3).
(5) Exception.--With respect to a State that
receives the minimum allotment under subsection (a)(1)
for a fiscal year, such State, from the amounts
received under a grant awarded under section 2611 for
such fiscal year for the activities described in
paragraphs (2) and (3), may, notwithstanding paragraphs
(2) through (4) \1\, use not more than that amount
required to support one full-time-equivalent employee.
---------------------------------------------------------------------------
\1\ Section 203(e)(5) of Public Law 109-415 (120 Stat. 2795) struck
``paragraphs (3)'' and all that follows through ``(5),'' and inserted
revised text. There were two references to ``paragraphs (3)''. The
amendment was executed to the first such reference to reflect the
probable intent of Congress.
---------------------------------------------------------------------------
(6) Construction.--A State may not use amounts
received under a grant awarded under section 2611 to
purchase or improve land, or to purchase, construct, or
permanently improve (other than minor remodeling) any
building or other facility, or to make cash payments to
intended recipients of services.
(c) Expedited Distribution.--
(1) In general.--Not less than 75 percent of the
amounts received under a grant awarded to a State under
section 2611 shall be obligated to specific programs
and projects and made available for expenditure not
later than--
(A) in the case of the first fiscal year
for which amounts are received, 150 days after
the receipt of such amounts by the State; and
(B) in the case of succeeding fiscal years,
120 days after the receipt of such amounts by
the State.
(2) Public comment.--Within the time periods
referred to in paragraph (1), the State shall invite
and receive public comment concerning methods for the
utilization of such amounts.
(d) Reallocation.--Any portion of a grant made to a State
under section 2611 for a fiscal year that has not been
obligated as described in subsection (c) ceases to be available
to the State and shall be made available by the Secretary for
grants under section 2620, in addition to amounts made
available for such grants under section 2623(b)(2).
SEC. 2619. [300FF-29] TECHNICAL ASSISTANCE.
The Secretary shall provide technical assistance in
administering and coordinating the activities authorized under
section 2612, including technical assistance for the
development and implementation of statewide coordinated
statements of need.
SEC. 2620. [300FF-29A] SUPPLEMENTAL GRANTS.
(a) In General.--For the purpose of providing services
described in section 2612(a), the Secretary shall make grants
to States--
(1) whose applications under section 2617 have
demonstrated the need in the State, on an objective and
quantified basis, for supplemental financial assistance
to provide such services; and
(2) that did not, for the most recent grant year
pursuant to section 2618(a)(1) or 2618(a)(2)(F)(i) for
which data is available, have more than 5 percent of
grant funds under such sections canceled, offset under
section 2622(e), or covered by any waivers under
section 2622(c).
(b) Demonstrated Need.--The factors considered by the
Secretary in determining whether an eligible area has a
demonstrated need for purposes of subsection (a)(1) may include
any or all of the following:
(1) The unmet need for such services, as determined
under section 2617(b).
(2) An increasing need for HIV/AIDS-related
services, including relative rates of increase in the
number of cases of HIV/AIDS.
(3) The relative rates of increase in the number of
cases of HIV/AIDS within new or emerging
subpopulations.
(4) The current prevalence of HIV/AIDS.
(5) Relevant factors related to the cost and
complexity of delivering health care to individuals
with HIV/AIDS in the eligible area.
(6) The impact of co-morbid factors, including co-
occurring conditions, determined relevant by the
Secretary.
(7) The prevalence of homelessness.
(8) The prevalence of individuals described under
section 2602(b)(2)(M).
(9) The relevant factors that limit access to
health care, including geographic variation, adequacy
of health insurance coverage, and language barriers.
(10) The impact of a decline in the amount received
pursuant to section 2618 on services available to all
individuals with HIV/AIDS identified and eligible under
this title.
(c) Priority in Making Grants.--The Secretary shall provide
funds under this section to a State to address the decline in
services related to the decline in the amounts received
pursuant to section 2618 consistent with the grant award to the
State for fiscal year 2006, to the extent that the factor under
subsection (b)(10) (relating to a decline in funding) applies
to the State.
(d) Report on the Awarding of Supplemental Funds.--Not
later than 45 days after the awarding of supplemental funds
under this section, the Secretary shall submit to Congress a
report concerning such funds. Such report shall include
information detailing--
(1) the total amount of supplemental funds
available under this section for the year involved;
(2) the amount of supplemental funds used in
accordance with the hold harmless provisions of section
2618(a)(2);
(3) the amount of supplemental funds disbursed
pursuant to subsection (c);
(4) the disbursement of the remainder of the
supplemental funds after taking into account the uses
described in paragraphs (2) and (3); and
(5) the rationale used for the amount of funds
disbursed as described under paragraphs (2), (3), and
(4).
(e) Core Medical Services.--The provisions of section
2612(b) apply with respect to a grant under this section to the
same extent and in the same manner as such provisions apply
with respect to a grant made pursuant to section 2618(a)(1).
(f) Applicability of Grant Authority.--The authority to
make grants under this section applies beginning with the first
fiscal year for which amounts are made available for such
grants under section 2623(b)(1).
SEC. 2621. [300FF-30] EMERGING COMMUNITIES.
(a) In General.--The Secretary shall award supplemental
grants to States determined to be eligible under subsection (b)
to enable such States to provide comprehensive services of the
type described in section 2612(a) to supplement the services
otherwise provided by the State under a grant under this
subpart in emerging communities within the State that are not
eligible to receive grants under part A.
(b) Eligibility.--To be eligible to receive a supplemental
grant under subsection (a), a State shall--
(1) be eligible to receive a grant under this
subpart;
(2) demonstrate the existence in the State of an
emerging community as defined in subsection (d)(1);
(3) agree that the grant will be used to provide
funds directly to emerging communities in the State,
separately from other funds under this title that are
provided by the State to such communities; and
(4) submit the information described in subsection
(c).
(c) Reporting Requirements.--A State that desires a grant
under this section shall, as part of the State application
submitted under section 2617, submit a detailed description of
the manner in which the State will use amounts received under
the grant and of the severity of need. Such description shall
include--
(1) a report concerning the dissemination of
supplemental funds under this section and the plan for
the utilization of such funds in the emerging
community;
(2) a demonstration of the existing commitment of
local resources, both financial and in-kind;
(3) a demonstration that the State will maintain
HIV-related activities at a level that is equal to not
less than the level of such activities in the State for
the 1-year period preceding the fiscal year for which
the State is applying to receive a grant under section
2611;
(4) a demonstration of the ability of the State to
utilize such supplemental financial resources in a
manner that is immediately responsive and cost
effective;
(5) a demonstration that the resources will be
allocated in accordance with the local demographic
incidence of AIDS including appropriate allocations for
services for infants, children, women, and families
with HIV/AIDS;
(6) a demonstration of the inclusiveness of the
planning process, with particular emphasis on affected
communities and individuals with HIV/AIDS; and
(7) a demonstration of the manner in which the
proposed services are consistent with local needs
assessments and the statewide coordinated statement of
need.
(d) Definitions of Emerging Community.--For purposes of
this section, the term ``emerging community'' means a
metropolitan area (as defined in section 2607) for which there
has been reported to and confirmed by the Director of the
Centers for Disease Control and Prevention a cumulative total
of at least 500, but fewer than 1,000, cases of AIDS during the
most recent period of 5 calendar years for which such data are
available.
(e) Continued Status as Emerging Community.--
Notwithstanding any other provision of this section, a
metropolitan area that is an emerging community for a fiscal
year continues to be an emerging community until the
metropolitan area fails, for three consecutive fiscal years--
(1) to meet the requirements of subsection (d); and
(2) to have a cumulative total of 750 or more
living cases of AIDS (reported to and confirmed by the
Director of the Centers for Disease Control and
Prevention) as of December 31 of the most recent
calendar year for which such data is available.
(f) Distribution.--The amount of a grant under subsection
(a) for a State for a fiscal year shall be an amount equal to
the product of--
(1) the amount available under section 2623(b)(1)
for the fiscal year; and
(2) a percentage equal to the ratio constituted by
the number of living cases of HIV/AIDS in emerging
communities in the State to the sum of the respective
numbers of such cases in such communities for all
States.
SEC. 2622. [300FF-31A] TIMEFRAME FOR OBLIGATION AND EXPENDITURE OF
GRANT FUNDS.
(a) Obligation by end of Grant Year.--Effective for fiscal
year 2007 and subsequent fiscal years, funds from a grant award
made to a State for a fiscal year pursuant to section
2618(a)(1) or 2618(a)(2)(F), or under section 2620 or 2621, are
available for obligation by the State through the end of the
one-year period beginning on the date in such fiscal year on
which funds from the award first become available to the State
(referred to in this section as the ``grant year for the
award''), except as provided in subsection (c)(1).
(b) Supplemental Grants; Cancellation of Unobligated
Balance of Grant Award.--Effective for fiscal year 2007 and
subsequent fiscal years, if a grant award made to a State for a
fiscal year pursuant to section 2618(a)(2)(F)(ii), or under
section 2620 or 2621, has an unobligated balance as of the end
of the grant year for the award--
(1) the Secretary shall cancel that unobligated
balance of the award, and shall require the State to
return any amounts from such balance that have been
disbursed to the State; and
(2) the funds involved shall be made available by
the Secretary as additional amounts for grants pursuant
to section 2620 for the first fiscal year beginning
after the fiscal year in which the Secretary obtains
the information necessary for determining that the
balance is required under paragraph (1) to be canceled,
except that the availability of the funds for such
grants is subject to section 2618(a)(2)(H) as applied
for such year.
(c) Formula Grants; Cancellation of Unobligated Balance of
Grant Award; Waiver Permitting Carryover.--
(1) In general.--Effective for fiscal year 2007 and
subsequent fiscal years, if a grant award made to a
State for a fiscal year pursuant to section 2618(a)(1)
or 2618(a)(2)(F)(i) has an unobligated balance as of
the end of the grant year for the award, the Secretary
shall cancel that unobligated balance of the award, and
shall require the State to return any amounts from such
balance that have been disbursed to the State, unless--
(A) before the end of the grant year, the
State submits to the Secretary a written
application for a waiver of the cancellation,
which application includes a description of the
purposes for which the State intends to expend
the funds involved; and
(B) the Secretary approves the waiver.
(2) Expenditure by end of carryover year.--With
respect to a waiver under paragraph (1) that is
approved for a balance that is unobligated as of the
end of a grant year for an award:
(A) The unobligated funds are available for
expenditure by the State involved for the one-
year period beginning upon the expiration of
the grant year (referred to in this section as
the ``carryover year'').
(B) If the funds are not expended by the
end of the carryover year, the Secretary shall
cancel that unexpended balance of the award,
and shall require the State to return any
amounts from such balance that have been
disbursed to the State.
(3) Use of cancelled balances.--In the case of any
balance of a grant award that is cancelled under
paragraph (1) or (2)(B), the grant funds involved shall
be made available by the Secretary as additional
amounts for grants under section 2620 for the first
fiscal year beginning after the fiscal year in which
the Secretary obtains the information necessary for
determining that the balance is required under such
paragraph to be canceled, except that the availability
of the funds for such grants is subject to section
2618(a)(2)(H) as applied for such year.
(4) Corresponding reduction in future grant.--
(A) In general.--In the case of a State for
which a balance from a grant award made
pursuant to section 2618(a)(1) or
2618(a)(2)(F)(i) is unobligated as of the end
of the grant year for the award--
(i) the Secretary shall reduce, by
the same amount as such unobligated
balance (less any amount of such
balance that is the subject of a waiver
of cancellation under paragraph (1)),
the amount of the grant under such
section for the first fiscal year
beginning after the fiscal year in
which the Secretary obtains the
information necessary for determining
that such balance was unobligated as of
the end of the grant year (which
requirement for a reduction applies
without regard to whether a waiver
under paragraph (1) has been approved
with respect to such balance); and
(ii) the grant funds involved in
such reduction shall be made available
by the Secretary as additional funds
for grants under section 2620 for such
first fiscal year, subject to section
2618(a)(2)(H);
except that this subparagraph does not apply to
the State if the amount of the unobligated
balance was 5 percent or less.
(B) Relation to increases in grant.--A
reduction under subparagraph (A) for a State
for a fiscal year may not be taken into account
in applying section 2618(a)(2)(H) with respect
to the State for the subsequent fiscal year.
(d) Treatment of Drug Rebates.--For purposes of this
section, funds that are drug rebates referred to in section
2616(g) may not be considered part of any grant award referred
to in subsection (a). If an expenditure of ADAP rebate funds
would trigger a penalty under this section or a higher penalty
than would otherwise have applied, the State may request that
for purposes of this section, the Secretary deem the State's
unobligated balance to be reduced by the amount of rebate funds
in the proposed expenditure. Notwithstanding 2618(a)(2)(F), any
unobligated amount under section 2618(a)(2)(F)(ii)(V) that is
returned to the Secretary for reallocation shall be used by the
Secretary for--
(1) the ADAP supplemental program if the Secretary
determines appropriate; or
(2) for additional amounts for grants pursuant to
section 2620.
(e) Authority Regarding Administration of Provisions.--In
administering subsections (b) and (c) with respect to the
unobligated balance of a State, the Secretary may elect to
reduce the amount of future grants to the State under section
2618, 2620, or 2621, as applicable, by the amount of any such
unobligated balance in lieu of cancelling such amount as
provided for in subsection (b) or (c)(1). In such case, the
Secretary may permit the State to use such unobligated balance
for purposes of any such future grant. An amount equal to such
reduction shall be available for use as additional amounts for
grants pursuant to section 2620, subject to section
2618(a)(2)(H). Nothing in this paragraph shall be construed to
affect the authority of the Secretary under subsections (b) and
(c), including the authority to grant waivers under subsection
(c)(1). The reduction in future grants authorized under this
subsection shall be notwithstanding the penalty required under
subsection (c)(4) with respect to unobligated funds.
SEC. 2623. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out this
subpart, there are authorized to be appropriated $1,195,500,000
for fiscal year 2007, $1,239,500,000 for fiscal year 2008,
$1,285,200,000 for fiscal year 2009, $1,349,460,000 for fiscal
year 2010, $1,416,933,000 for fiscal year 2011, $1,487,780,000
for fiscal year 2012, and $1,562,169,000 for fiscal year 2013.
Amounts appropriated under the preceding sentence for a fiscal
year are available for obligation by the Secretary until the
end of the second succeeding fiscal year.
(b) Reservation of Amounts.--
(1) Emerging communities.--Of the amount
appropriated under subsection (a) for a fiscal year,
the Secretary shall reserve $5,000,000 for grants under
section 2621.
(2) Supplemental grants.--
(A) In general.--Of the amount appropriated
under subsection (a) for a fiscal year in
excess of the 2006 adjusted amount, the
Secretary shall reserve \1/3\ for grants under
section 2620, except that the availability of
the reserved funds for such grants is subject
to section 2618(a)(2)(H) as applied for such
year, and except that any amount appropriated
exclusively for carrying out section 2616 (and,
accordingly, distributed under section
2618(a)(2)(F)) is not subject to this
subparagraph.
(B) 2006 adjusted amount.--For purposes of
subparagraph (A), the term ``2006 adjusted
amount'' means the amount appropriated for
fiscal year 2006 under section 2677(b) (as such
section was in effect for such fiscal year),
excluding any amount appropriated for such year
exclusively for carrying out section 2616 (and,
accordingly, distributed under section
2618(a)(2)(I), as so in effect).
Subpart II--Provisions Concerning Pregnancy and Perinatal Transmission
of HIV
SEC. 2625. [300FF-33] EARLY DIAGNOSIS GRANT PROGRAM.
(a) In General.--In the case of States whose laws or
regulations are in accordance with subsection (b), the
Secretary, acting through the Centers for Disease Control and
Prevention, shall make grants to such States for the purposes
described in subsection (c).
(b) Description of Compliant States.--For purposes of
subsection (a), the laws or regulations of a State are in
accordance with this subsection if, under such laws or
regulations (including programs carried out pursuant to the
discretion of State officials), both of the policies described
in paragraph (1) are in effect, or both of the policies
described in paragraph (2) are in effect, as follows:
(1)(A) Voluntary opt-out testing of pregnant women.
(B) Universal testing of newborns.
(2)(A) Voluntary opt-out testing of clients at
sexually transmitted disease clinics.
(B) Voluntary opt-out testing of clients at
substance abuse treatment centers.
The Secretary shall periodically ensure that the applicable
policies are being carried out and recertify compliance.
(c) Use of Funds.--A State may use funds provided under
subsection (a) for HIV/AIDS testing (including rapid testing),
prevention counseling, treatment of newborns exposed to HIV/
AIDS, treatment of mothers infected with HIV/AIDS, and costs
associated with linking those diagnosed with HIV/AIDS to care
and treatment for HIV/AIDS.
(d) Application.--A State that is eligible for the grant
under subsection (a) shall submit an application to the
Secretary, in such form, in such manner, and containing such
information as the Secretary may require.
(e) Limitation on Amount of Grant.--A grant under
subsection (a) to a State for a fiscal year may not be made in
an amount exceeding $10,000,000.
(f) Rule of Construction.--Nothing in this section shall be
construed to pre-empt State laws regarding HIV/AIDS counseling
and testing.
(g) Definitions.--In this section:
(1) The term ``voluntary opt-out testing'' means
HIV/AIDS testing--
(A) that is administered to an individual
seeking other health care services; and
(B) in which--
(i) pre-test counseling is not
required but the individual is informed
that the individual will receive an
HIV/AIDS test and the individual may
opt out of such testing; and
(ii) for those individuals with a
positive test result, post-test
counseling (including referrals for
care) is provided and confidentiality
is protected.
(2) The term ``universal testing of newborns''
means HIV/AIDS testing that is administered within 48
hours of delivery to--
(A) all infants born in the State; or
(B) all infants born in the State whose
mother's HIV/AIDS status is unknown at the time
of delivery.
(h) Authorization of Appropriations.--Of the funds
appropriated annually to the Centers for Disease Control and
Prevention for HIV/AIDS prevention activities, $30,000,000
shall be made available for each of the fiscal years 2007
through 2009 for grants under subsection (a), of which
$20,000,000 shall be made available for grants to States with
the policies described in subsection (b)(1), and $10,000,000
shall be made available for grants to States with the policies
described in subsection (b)(2). Funds provided under this
section are available until expended.
SEC. 2626. [300FF-34] PERINATAL TRANSMISSION OF HIV DISEASE;
CONTINGENT REQUIREMENT REGARDING STATE GRANTS UNDER
THIS PART.
(a) Annual Determination of Reported Cases.--A State shall
annually determine the rate of reported cases of AIDS as a
result of perinatal transmission among residents of the State.
(b) Causes of Perinatal Transmission.--In determining the
rate under subsection (a), a State shall also determine the
possible causes of perinatal transmission. Such causes may
include--
(1) the inadequate provision within the State of
prenatal counseling and testing in accordance with the
guidelines issued by the Centers for Disease Control
and Prevention;
(2) the inadequate provision or utilization within
the State of appropriate therapy or failure of such
therapy to reduce perinatal transmission of HIV,
including--
(A) that therapy is not available,
accessible or offered to mothers; or
(B) that available therapy is offered but
not accepted by mothers; or
(3) other factors (which may include the lack of
prenatal care) determined relevant by the State.
(c) CDC Reporting System.--Not later than 4 months after
the date of enactment of this subpart, the Director of the
Centers for Disease Control and Prevention shall develop and
implement a system to be used by States to comply with the
requirements of subsections (a) and (b). The Director shall
issue guidelines to ensure that the data collected is
statistically valid.
SEC. 2627. [300FF-37] STATE HIV TESTING PROGRAMS ESTABLISHED PRIOR TO
OR AFTER ENACTMENT.
Nothing in this subpart shall be construed to disqualify a
State from receiving grants under this title if such State has
established at any time prior to or after the date of enactment
of this subpart a program of mandatory HIV testing.
SEC. 2628. [300FF-37A] RECOMMENDATIONS FOR REDUCING INCIDENCE OF
PERINATAL TRANSMISSION.
(a) Study by Institute of Medicine.--
(1) In general.--The Secretary shall request the
Institute of Medicine to enter into an agreement with
the Secretary under which such Institute conducts a
study to provide the following:
(A) For the most recent fiscal year for
which the information is available, a
determination of the number of newborn infants
with HIV born in the United States with respect
to whom the attending obstetrician for the
birth did not know the HIV status of the
mother.
(B) A determination for each State of any
barriers, including legal barriers, that
prevent or discourage an obstetrician from
making it a routine practice to offer pregnant
women an HIV test and a routine practice to
test newborn infants for HIV/AIDS in
circumstances in which the obstetrician does
not know the HIV status of the mother of the
infant.
(C) Recommendations for each State for
reducing the incidence of cases of the
perinatal transmission of HIV, including
recommendations on removing the barriers
identified under subparagraph (B).
If such Institute declines to conduct the study, the
Secretary shall enter into an agreement with another
appropriate public or nonprofit private entity to
conduct the study.
(2) Report.--The Secretary shall ensure that, not
later than 18 months after the effective date of this
section, the study required in paragraph (1) is
completed and a report describing the findings made in
the study is submitted to the appropriate committees of
the Congress, the Secretary, and the chief public
health official of each of the States.
(b) Progress Toward Recommendations.--In fiscal year 2004,
the Secretary shall collect information from the States
describing the actions taken by the States toward meeting the
recommendations specified for the States under subsection
(a)(1)(C).
(c) Submission of Reports to Congress.--The Secretary shall
submit to the appropriate committees of the Congress reports
describing the information collected under subsection (b).
Subpart III--Certain Partner Notification Programs
SEC. 2631. [300FF-38] GRANTS FOR PARTNER NOTIFICATION PROGRAMS.
(a) In General.--In the case of States whose laws or
regulations are in accordance with subsection (b), the
Secretary, subject to subsection (c)(2), may make grants to the
States for carrying out programs to provide partner counseling
and referral services.
(b) Description of Compliant State Programs.--For purposes
of subsection (a), the laws or regulations of a State are in
accordance with this subsection if under such laws or
regulations (including programs carried out pursuant to the
discretion of State officials) the following policies are in
effect:
(1) The State requires that the public health
officer of the State carry out a program of partner
notification to inform partners of individuals with
HIV/AIDS that the partners may have been exposed to the
disease.
(2)(A) In the case of a health entity that provides
for the performance on an individual of a test for HIV/
AIDS, or that treats the individual for the disease,
the State requires, subject to subparagraph (B), that
the entity confidentially report the positive test
results to the State public health officer in a manner
recommended and approved by the Director of the Centers
for Disease Control and Prevention, together with such
additional information as may be necessary for carrying
out such program.
(B) The State may provide that the requirement of
subparagraph (A) does not apply to the testing of an
individual for HIV/AIDS if the individual underwent the
testing through a program designed to perform the test
and provide the results to the individual without the
individual disclosing his or her identity to the
program. This subparagraph may not be construed as
affecting the requirement of subparagraph (A) with
respect to a health entity that treats an individual
for HIV/AIDS.
(3) The program under paragraph (1) is carried out
in accordance with the following:
(A) Partners are provided with an
appropriate opportunity to learn that the
partners have been exposed to HIV/AIDS, subject
to subparagraph (B).
(B) The State does not inform partners of
the identity of the infected individuals
involved.
(C) Counseling and testing for HIV/AIDS are
made available to the partners and to infected
individuals, and such counseling includes
information on modes of transmission for the
disease, including information on prenatal and
perinatal transmission and preventing
transmission.
(D) Counseling of infected individuals and
their partners includes the provision of
information regarding therapeutic measures for
preventing and treating the deterioration of
the immune system and conditions arising from
the disease, and the provision of other
prevention-related information.
(E) Referrals for appropriate services are
provided to partners and infected individuals,
including referrals for support services and
legal aid.
(F) Notifications under subparagraph (A)
are provided in person, unless doing so is an
unreasonable burden on the State.
(G) There is no criminal or civil penalty
on, or civil liability for, an infected
individual if the individual chooses not to
identify the partners of the individual, or the
individual does not otherwise cooperate with
such program.
(H) The failure of the State to notify
partners is not a basis for the civil liability
of any health entity who under the program
reported to the State the identity of the
infected individual involved.
(I) The State provides that the provisions
of the program may not be construed as
prohibiting the State from providing a
notification under subparagraph (A) without the
consent of the infected individual involved.
(4) The State annually reports to the Director of
the Centers for Disease Control and Prevention the
number of individuals from whom the names of partners
have been sought under the program under paragraph (1),
the number of such individuals who provided the names
of partners, and the number of partners so named who
were notified under the program.
(5) The State cooperates with such Director in
carrying out a national program of partner
notification, including the sharing of information
between the public health officers of the States.
(c) Reporting System for Cases of HIV Disease; Preference
in Making Grants.--In making grants under subsection (a), the
Secretary shall give preference to States whose reporting
systems for cases of HIV/AIDS produce data on such cases that
is sufficiently accurate and reliable for use for purposes of
section 2618(a)(2)(D)(i).
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there is authorized to be
appropriated $10,000,000 for each of the fiscal years 2007
through 2009.
Part C--Early Intervention Services
Subpart I--Categorical Grants
SEC. 2651. [300FF-51] ESTABLISHMENT OF A PROGRAM.
(a) In General.--For the purposes described in subsection
(b), the Secretary, acting through the Administrator of the
Health Resources and Services Administration, may make grants
to public and nonprofit private entities specified in section
2652(a).
(b) Requirements.--
(1) In general.--The Secretary may not make a grant
under subsection (a) unless the applicant for the grant
agrees to expend the grant only for--
(A) core medical services described in
subsection (c);
(B) support services described in
subsection (d); and
(C) administrative expenses as described in
section 2664(g)(3).
(2) Early intervention services.--An applicant for
a grant under subsection (a) shall expend not less than
50 percent of the amount received under the grant for
the services described in subparagraphs (B) through (E)
of subsection (e)(1) for individuals with HIV/AIDS.
(c) Required Funding for Core Medical Services.--
(1) In general.--With respect to a grant under
subsection (a) to an applicant for a fiscal year, the
applicant shall, of the portion of the grant remaining
after reserving amounts for purposes of paragraphs (3)
and (5) of section 2664(g), use not less than 75
percent to provide core medical services that are
needed in the area involved for individuals with HIV/
AIDS who are identified and eligible under this title
(including services regarding the co-occurring
conditions of the individuals).
(2) Waiver.--
(A) The Secretary shall waive the
application of paragraph (1) with respect to an
applicant for a grant if the Secretary
determines that, within the service area of the
applicant--
(i) there are no waiting lists for
AIDS Drug Assistance Program services
under section 2616; and
(ii) core medical services are
available to all individuals with HIV/
AIDS identified and eligible under this
title.
(B) Notification of waiver status.--When
informing an applicant that a grant under
subsection (a) is being made for a fiscal year,
the Secretary shall inform the applicant
whether a waiver under subparagraph (A) is in
effect for the fiscal year.
(3) Core medical services.--For purposes of this
subsection, the term ``core medical services'', with
respect to an individual with HIV/AIDS (including the
co-occurring conditions of the individual) means the
following services:
(A) Outpatient and ambulatory health
services.
(B) AIDS Drug Assistance Program treatments
under section 2616.
(C) AIDS pharmaceutical assistance.
(D) Oral health care.
(E) Early intervention services described
in subsection (e).
(F) Health insurance premium and cost
sharing assistance for low-income individuals
in accordance with section 2615.
(G) Home health care.
(H) Medical nutrition therapy.
(I) Hospice services.
(J) Home and community-based health
services as defined under section 2614(c).
(K) Mental health services.
(L) Substance abuse outpatient care.
(M) Medical case management, including
treatment adherence services.
(d) Support Services.--
(1) In general.--For purposes of this section, the
term ``support services'' means services, subject to
the approval of the Secretary, that are needed for
individuals with HIV/AIDS to achieve their medical
outcomes (such as respite care for persons caring for
individuals with HIV/AIDS, outreach services, medical
transportation, linguistic services, and referrals for
health care and support services).
(2) Definition of medical outcomes.--In this
section, the term ``medical outcomes'' means those
outcomes affecting the HIV-related clinical status of
an individual with HIV/AIDS.
(e) Specification of Early Intervention Services.--
(1) In general.--The early intervention services
referred to in this section are--
(A) counseling individuals with respect to
HIV/AIDS in accordance with section 2662;
(B) testing individuals with respect to
HIV/AIDS, including tests to confirm the
presence of the disease, tests to diagnose the
extent of the deficiency in the immune system,
and tests to provide information on appropriate
therapeutic measures for preventing and
treating the deterioration of the immune system
and for preventing and treating conditions
arising from HIV/AIDS;
(C) referrals described in paragraph (2);
(D) other clinical and diagnostic services
regarding HIV/AIDS, and periodic medical
evaluations of individuals with HIV/AIDS; and
(E) providing the therapeutic measures
described in subparagraph (B).
(2) Referrals.--The services referred to in
paragraph (1)(C) are referrals of individuals with HIV/
AIDS to appropriate providers of health and support
services, including, as appropriate--
(A) to entities receiving amounts under
part A or B for the provision of such services;
(B) to biomedical research facilities of
institutions of higher education that offer
experimental treatment for such disease, or to
community-based organizations or other entities
that provide such treatment; or
(C) to grantees under section 2671, in the
case of a pregnant woman.
(3) Requirement of availability of all early
intervention services through each grantee.--
(A) In general.--The Secretary may not make
a grant under subsection (a) unless the
applicant for the grant agrees that each of the
early intervention services specified in
paragraph (2) will be available through the
grantee. With respect to compliance with such
agreement, such a grantee may expend the grant
to provide the early intervention services
directly, and may expend the grant to enter
into agreements with public or nonprofit
private entities, or private for-profit
entities if such entities are the only
available provider of quality HIV care in the
area, under which the entities provide the
services.
(B) Other requirements.--Grantees described
in--
(i) subparagraphs (A), (D), (E),
and (F) of section 2652(a)(1) shall use
not less than 50 percent of the amount
of such a grant to provide the services
described in subparagraphs (A), (B),
(D), and (E) of paragraph (1) directly
and on-site or at sites where other
primary care services are rendered; and
(ii) subparagraphs (B) and (C) of
section 2652(a)(1) shall ensure the
availability of early intervention
services through a system of linkages
to community-based primary care
providers, and to establish mechanisms
for the referrals described in
paragraph (1)(C), and for follow-up
concerning such referrals.
SEC. 2652. [300FF-52] MINIMUM QUALIFICATIONS OF GRANTEES.
(a) Eligible Entities.--
(1) In general.--The entities referred to in
section 2651(a) are public entities and nonprofit
private entities that are--
(A) federally-qualified health centers
under section 1905(l)(2)(B) of the Social
Security Act;
(B) grantees under section 1001 (regarding
family planning) other than States;
(C) comprehensive hemophilia diagnostic and
treatment centers;
(D) rural health clinics;
(E) health facilities operated by or
pursuant to a contract with the Indian Health
Service;
(F) community-based organizations, clinics,
hospitals and other health facilities that
provide early intervention services to those
persons infected with HIV/AIDS through
intravenous drug use; or
(G) nonprofit private entities that provide
comprehensive primary care services to
populations at risk of HIV/AIDS, including
faith-based and community-based organizations.
(2) Underserved populations.--Entities described in
paragraph (1) shall serve underserved populations which
may include minority populations and Native American
populations, ex-offenders, individuals with
comorbidities including hepatitis B or C, mental
illness, or substance abuse, low-income populations,
inner city populations, and rural populations. \1\;
---------------------------------------------------------------------------
\1\ See footnote for section 217(a).
---------------------------------------------------------------------------
(b) Status as Medicaid Provider.--
(1) In general.--Subject to paragraph (2), the
Secretary may not make a grant under section 2651 for
the provision of services described in subsection (b)
of such section in a State unless, in the case of any
such service that is available pursuant to the State
plan approved under title XIX of the Social Security
Act for the State--
(A) the applicant for the grant will
provide the service directly, and the applicant
has entered into a participation agreement
under the State plan and is qualified to
receive payments under such plan; or
(B) the applicant for the grant will enter
into an agreement with a public or nonprofit
private entity, or a private for-profit entity
if such entity is the only available provider
of quality HIV care in the area, under which
the entity will provide the service, and the
entity has entered into such a participation
agreement and is qualified to receive such
payments.
(2) Waiver regarding certain secondary
agreements.--
(A) In the case of an entity making an
agreement pursuant to paragraph (1)(B)
regarding the provision of services, the
requirement established in such paragraph
regarding a participation agreement shall be
waived by the Secretary if the entity does not,
in providing health care services, impose a
charge or accept reimbursement available from
any third-party payor, including reimbursement
under any insurance policy or under any Federal
or State health benefits program.
(B) A determination by the Secretary of
whether an entity referred to in subparagraph
(A) meets the criteria for a waiver under such
subparagraph shall be made without regard to
whether the entity accepts voluntary donations
regarding the provision of services to the
public.
SEC. 2653. [300FF-53] PREFERENCES IN MAKING GRANTS.
(a) In General.--In making grants under section 2651, the
Secretary shall give preference to any qualified applicant
experiencing an increase in the burden of providing services
regarding HIV/AIDS, as indicated by the factors specified in
subsection (b).
(b) Specification of Factors.--
(1) In general.--In the case of the geographic area
with respect to which the entity involved is applying
for a grant under section 2651, the factors referred to
in subsection (a), as determined for the period
specified in paragraph (2), are--
(A) the number of cases of HIV/AIDS;
(B) the rate of increase in such cases;
(C) the lack of availability of early
intervention services;
(D) the number of other cases of sexually
transmitted diseases, and the number of cases
of tuberculosis and of drug abuse and the
number of cases of individuals co-infected with
HIV/AIDS and hepatitis B or C;
(E) the rate of increase in each of the
cases specified in subparagraph (D);
(F) the lack of availability of primary
health services from providers other than such
applicant; and
(G) the distance between such area and the
nearest community that has an adequate level of
availability of appropriate HIV-related
services, and the length of time required to
travel such distance.
(2) Relevant period of time.--The period referred
to in paragraph (1) is the 2-year period preceding the
fiscal year for which the entity involved is applying
to receive a grant under section 2651.
(c) Equitable Allocations.--In providing preferences for
purposes of subsection (b), the Secretary shall equitably
allocate the preferences among urban and rural areas.
(d) Certain Areas.--Of the applicants who qualify for
preference under this section--
(1) the Secretary shall give preference to
applicants that will expend the grant under section
2651 to provide early intervention under such section
in rural areas; and
(2) the Secretary shall give preference to areas
that are underserved with respect to such services.
SEC. 2654. [300FF-54] MISCELLANEOUS PROVISIONS.
(a) Services for Individuals With Hemophilia.--In making
grants under section 2651, the Secretary shall ensure that any
such grants made regarding the provision of early intervention
services to individuals with hemophilia are made through the
network of comprehensive hemophilia diagnostic and treatment
centers.
(b) Technical Assistance.--The Secretary may, directly or
through grants or contracts, provide technical assistance to
nonprofit private entities regarding the process of submitting
to the Secretary applications for grants under section 2651,
and may provide technical assistance with respect to the
planning, development, and operation of any program or service
carried out pursuant to such section.
(c) Planning and Development Grants.--
(1) In general.--The Secretary may provide planning
grants to public and nonprofit private entities for
purposes of--
(A) enabling such entities to provide early
intervention services; and
(B) assisting the entities in expanding
their capacity to provide HIV/AIDS-related
health services, including early intervention
services, in low-income communities and
affected subpopulations that are underserved
with respect to such services (subject to the
condition that a grant pursuant to this
subparagraph may not be expended to purchase or
improve land, or to purchase, construct, or
permanently improve, other than minor
remodeling, any building or other facility).
(2) Requirement.--The Secretary may only award a
grant to an entity under paragraph (1) if the Secretary
determines that the entity will use such grant to
assist the entity in qualifying for a grant under
section 2651.
(3) Preference.--In awarding grants under paragraph
(1), the Secretary shall give preference to entities
that provide primary care services in rural areas or to
underserved populations.
(4) Amount and duration of grants.--
(A) Early intervention services.--A grant
under paragraph (1)(A) may be made in an amount
not to exceed $50,000.
(B) Capacity development.--
(i) Amount.--A grant under
paragraph (1)(B) may be made in an
amount not to exceed $150,000.
(ii) Duration.--The total duration
of a grant under paragraph (1)(B),
including any renewal, may not exceed 3
years.
(5) Limitation.--Not to exceed 5 percent of the
amount appropriated for a fiscal year under section
2655 may be used to carry out this section.
SEC. 2655. [300FF-55] AUTHORIZATION OF APPROPRIATIONS.
For the purpose of making grants under section 2651, there
are authorized to be appropriated, $218,600,000 for fiscal year
2007, $226,700,000 for fiscal year 2008, $235,100,000 for
fiscal year 2009, $246,855,000 for fiscal year 2010,
$259,198,000 for fiscal year 2011, $272,158,000 for fiscal year
2012, and $285,766,000 for fiscal year 2013.
Subpart II--General Provisions
SEC. 2661. [300FF-61] CONFIDENTIALITY AND INFORMED CONSENT.
(a) Confidentiality.--The Secretary may not make a grant
under this part unless, in the case of any entity applying for
a grant under section 2651, the entity agrees to ensure that
information regarding the receipt of early intervention
services pursuant to the grant is maintained confidentially in
a manner not inconsistent with applicable law.
(b) Informed Consent.--The Secretary may not make a grant
under this part unless the applicant for the grant agrees that,
in testing an individual for HIV/AIDS, the applicant will test
an individual only after the individual confirms that the
decision of the individual with respect to undergoing such
testing is voluntarily made.
SEC. 2662. [300FF-62] PROVISION OF CERTAIN COUNSELING SERVICES.
(a) Counseling of Individuals With Negative Test Results.--
The Secretary may not make a grant under this part unless the
applicant for the grant agrees that, if the results of testing
conducted for HIV/AIDS indicate that an individual does not
have such condition, the applicant will provide the individual
information, including--
(1) measures for prevention of, exposure to, and
transmission of HIV/AIDS, hepatitis B, hepatitis C, and
other sexually transmitted diseases;
(2) the accuracy and reliability of results of
testing for HIV/AIDS, hepatitis B, and hepatitis C;
(3) the significance of the results of such
testing, including the potential for developing AIDS,
hepatitis B, or hepatitis C;
(4) the appropriateness of further counseling,
testing, and education of the individual regarding HIV/
AIDS and other sexually transmitted diseases;
(5) if diagnosed with chronic hepatitis B or
hepatitis C co-infection, the potential of developing
hepatitis-related liver disease and its impact on HIV/
AIDS; and
(6) information regarding the availability of
hepatitis B vaccine and information about hepatitis
treatments.
(b) Counseling of Individuals With Positive Test Results.--
The Secretary may not make a grant under this part unless the
applicant for the grant agrees that, if the results of testing
for HIV/AIDS indicate that the individual has such condition,
the applicant will provide to the individual appropriate
counseling regarding the condition, including--
(1) information regarding--
(A) measures for prevention of, exposure
to, and transmission of HIV/AIDS, hepatitis B,
and hepatitis C;
(B) the accuracy and reliability of results
of testing for HIV/AIDS, hepatitis B, and
hepatitis C; and
(C) the significance of the results of such
testing, including the potential for developing
AIDS, hepatitis B, or hepatitis C;
(2) reviewing the appropriateness of further
counseling, testing, and education of the individual
regarding HIV/AIDS and other sexually transmitted
diseases; and
(3) providing counseling--
(A) on the availability, through the
applicant, of early intervention services;
(B) on the availability in the geographic
area of appropriate health care, mental health
care, and social and support services,
including providing referrals for such
services, as appropriate;
(C)(i) that explains the benefits of
locating and counseling any individual by whom
the infected individual may have been exposed
to HIV/AIDS, hepatitis B, or hepatitis C and
any individual whom the infected individual may
have exposed to HIV/AIDS, hepatitis B, or
hepatitis C; and
(ii) that emphasizes it is the duty of
infected individuals to disclose their infected
status to their sexual partners and their
partners in the sharing of hypodermic needles;
that provides advice to infected individuals on
the manner in which such disclosures can be
made; and that emphasizes that it is the
continuing duty of the individuals to avoid any
behaviors that will expose others to HIV/AIDS,
hepatitis B, or hepatitis C; and
(D) on the availability of the services of
public health authorities with respect to
locating and counseling any individual
described in subparagraph (C);
(4) if diagnosed with chronic hepatitis B or
hepatitis C co-infection, the potential of developing
hepatitis-related liver disease and its impact on HIV/
AIDS; and
(5) information regarding the availability of
hepatitis B vaccine.
(c) Additional Requirements Regarding Appropriate
Counseling.--The Secretary may not make a grant under this part
unless the applicant for the grant agrees that, in counseling
individuals with respect to HIV/AIDS, the applicant will ensure
that the counseling is provided under conditions appropriate to
the needs of the individuals.
(d) Counseling of Emergency Response Employees.--The
Secretary may not make a grant under this part to a State
unless the State agrees that, in counseling individuals with
respect to HIV/AIDS, the State will ensure that, in the case of
emergency response employees, the counseling is provided to
such employees under conditions appropriate to the needs of the
employees regarding the counseling.
(e) Rule of Construction Regarding Counseling Without
Testing.--Agreements made pursuant to this section may not be
construed to prohibit any grantee under this part from
expending the grant for the purpose of providing counseling
services described in this section to an individual who does
not undergo testing for HIV/AIDS as a result of the grantee or
the individual determining that such testing of the individual
is not appropriate.
SEC. 2663. [300FF-63] APPLICABILITY OF REQUIREMENTS REGARDING
CONFIDENTIALITY, INFORMED CONSENT, AND COUNSELING.
The Secretary may not make a grant under this part unless
the applicant for the grant agrees that, with respect to
testing for HIV/AIDS, any such testing carried out by the
applicant with funds appropriated through this Act will be
carried out in accordance with conditions described in sections
2661 and 2662.
SEC. 2664. [300FF-64] ADDITIONAL REQUIRED AGREEMENTS.
(a) Reports to Secretary.--The Secretary may not make a
grant under this part unless--
(1) the applicant submits to the Secretary--
(A) a specification of the expenditures
made by the applicant for early intervention
services for the fiscal year preceding the
fiscal year for which the applicant is applying
to receive the grant;
(B) an estimate of the number of
individuals to whom the applicant has provided
such services for such fiscal year;
(C) information regarding how the expected
expenditures of the grant are related to the
planning process for localities funded under
part A (including the planning process
described in section 2602) and for States
funded under part B (including the planning
process described in section 2617(b)); and
(D) a specification of the expected
expenditures and how those expenditures will
improve overall client outcomes, as described
in the State plan under section 2617(b);
(2) the applicant agrees to submit to the Secretary
a report providing--
(A) the number of individuals to whom the
applicant provides early intervention services
pursuant to the grant;
(B) epidemiological and demographic data on
the population of such individuals;
(C) the extent to which the costs of HIV-
related health care for such individuals are
paid by third-party payors;
(D) the average costs of providing each
category of early intervention service; and
(E) the aggregate amounts expended for each
such category;
(3) the applicant agrees to provide additional
documentation to the Secretary regarding the process
used to obtain community input into the design and
implementation of activities related to such grant; and
(4) the applicant agrees to submit, every 2 years,
to the lead State agency under section 2617(b)(4)
audits, consistent with Office of Management and Budget
circular A133, regarding funds expended in accordance
with this title and shall include necessary client
level data to complete unmet need calculations and
Statewide coordinated statements of need process.
(b) Provision of Opportunities for Anonymous Counseling and
Testing.--The Secretary may not make a grant under this part
unless the applicant for the grant agrees that, to the extent
permitted under State law, regulation or rule, the applicant
will offer substantial opportunities for an individual--
(1) to undergo counseling and testing regarding
HIV/AIDS without being required to provide any
information relating to the identity of the individual;
and
(2) to undergo such counseling and testing through
the use of a pseudonym.
(c) Prohibition Against Requiring Testing as Condition of
Receiving Other Health Services.--The Secretary may not make a
grant under this part unless the applicant for the grant agrees
that, with respect to an individual seeking health services
from the applicant, the applicant will not require the
individual to undergo testing for HIV as a condition of
receiving any health services unless such testing is medically
indicated in the provision of the health services sought by the
individual.
(d) Maintenance of Support.--The Secretary may not make a
grant under this part unless the applicant for the grant agrees
to maintain the expenditures of the applicant for early
intervention services at a level equal to not less than the
level of such expenditures maintained by the State for the
fiscal year preceding the fiscal year for which the applicant
is applying to receive the grant.
(e) Requirements Regarding Imposition of Charges for
Services.--
(1) In general.--The Secretary may not make a grant
under this part unless, subject to paragraph (5), the
applicant for the grant agrees that--
(A) in the case of individuals with an
income less than or equal to 100 percent of the
official poverty line, the applicant will not
impose a charge on any such individual for the
provision of early intervention services under
the grant;
(B) in the case of individuals with an
income greater than 100 percent of the official
poverty line, the applicant--
(i) will impose a charge on each
such individual for the provision of
such services; and
(ii) will impose the charge
according to a schedule of charges that
is made available to the public.
(2) Limitation on charges regarding individuals
subject to charges.--With respect to the imposition of
a charge for purposes of paragraph (1)(B)(ii), the
Secretary may not make a grant under this part unless,
subject to paragraph (5), the applicant for the grant
agrees that--
(A) in the case of individuals with an
income greater than 100 percent of the official
poverty line and not exceeding 200 percent of
such poverty line, the applicant will not, for
any calendar year, impose charges in an amount
exceeding 5 percent of the annual gross income
of the individual involved;
(B) in the case of individuals with an
income greater than 200 percent of the official
poverty line and not exceeding 300 percent of
such poverty line, the applicant will not, for
any calendar year, impose charges in an amount
exceeding 7 percent of the annual gross income
of the individual involved; and
(C) in the case of individuals with an
income greater than 300 percent of the official
poverty line, the applicant will not, for any
calendar year, impose charges in an amount
exceeding 10 percent of the annual gross income
of the individual involved.
(3) Assessment of charge.--With respect to
compliance with the agreement made under paragraph (1),
a grantee under this part may, in the case of
individuals subject to a charge for purposes of such
paragraph--
(A) assess the amount of the charge in the
discretion of the grantee, including imposing
only a nominal charge for the provision of
services, subject to the provisions of such
paragraph regarding public schedules and of
paragraph (2) regarding limitations on the
maximum amount of charges; and
(B) take into consideration the medical
expenses of individuals in assessing the amount
of the charge, subject to such provisions.
(4) Applicability of limitation on amount of
charge.--The Secretary may not make a grant under this
part unless the applicant for the grant agrees that the
limitations established in paragraph (2) regarding the
imposition of charges for services applies to the
annual aggregate of charges imposed for such services,
without regard to whether they are characterized as
enrollment fees, premiums, deductibles, cost sharing,
copayments, coinsurance, or similar charges.
(5) Waiver regarding certain secondary
agreements.--The requirement established in paragraph
(1)(B)(i) shall be waived by the Secretary in the case
of any entity for whom the Secretary has granted a
waiver under section 2652(b)(2).
(f) Relationship to Items and Services Under Other
Programs.--
(1) In general.--The Secretary may not make a grant
under this part unless the applicant for the grant
agrees that, subject to paragraph (2), the grant will
not be expended by the applicant, or by any entity
receiving amounts from the applicant for the provision
of early intervention services, to make payment for any
such service to the extent that payment has been made,
or can reasonably be expected to be made, with respect
to such service--
(A) under any State compensation program,
under an insurance policy, or under any Federal
or State health benefits program (except for a
program administered by or providing the
services of the Indian Health Service); or
(B) by an entity that provides health
services on a prepaid basis.
(2) Applicability to certain secondary agreements
for provision of services.--An agreement made under
paragraph (1) shall not apply in the case of an entity
through which a grantee under this part provides early
intervention services if the Secretary has provided a
waiver under section 2652(b)(2) regarding the entity.
(g) Administration of Grant.--The Secretary may not make a
grant under this part unless the applicant for the grant agrees
that--
(1) the applicant will not expend amounts received
pursuant to this part for any purpose other than the
purposes described in the subpart under which the grant
involved is made;
(2) the applicant will establish such procedures
for fiscal control and fund accounting as may be
necessary to ensure proper disbursement and accounting
with respect to the grant;
(3) the applicant will not expend more than 10
percent of the grant for administrative expenses with
respect to the grant, including planning and
evaluation, except that the costs of a clinical quality
management program under paragraph (5) may not be
considered administrative expenses for purposes of such
limitation;
(4) the applicant will submit evidence that the
proposed program is consistent with the statewide
coordinated statement of need and agree to participate
in the ongoing revision of such statement of need; and
(5) the applicant will provide for the
establishment of a clinical quality management
program--
(A) to assess the extent to which medical
services funded under this title that are
provided to patients are consistent with the
most recent Public Health Service guidelines
for the treatment of HIV/AIDS and related
opportunistic infections, and as applicable, to
develop strategies for ensuring that such
services are consistent with the guidelines;
and
(B) to ensure that improvements in the
access to and quality of HIV health services
are addressed.
SEC. 2665. [300FF-65] REQUIREMENT OF SUBMISSION OF APPLICATION
CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
The Secretary may not make a grant under this part unless--
(1) an application for the grant is submitted to
the Secretary containing agreements and assurances in
accordance with this part and containing the
information specified in section 2664(a)(1);
(2) with respect to such agreements, the
application provides assurances of compliance
satisfactory to the Secretary; and
(3) the application otherwise is in such form, is
made in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out this part.
SEC. 2666. [300FF-66] PROVISION BY SECRETARY OF SUPPLIES AND SERVICES
IN LIEU OF GRANT FUNDS.
(a) In General.--Upon the request of a grantee under this
part, the Secretary may, subject to subsection (b), provide
supplies, equipment, and services for the purpose of aiding the
grantee in providing early intervention services and, for such
purpose, may detail to the State any officer or employee of the
Department of Health and Human Services.
(b) Limitation.--With respect to a request described in
subsection (a), the Secretary shall reduce the amount of
payments under the grant involved by an amount equal to the
costs of detailing personnel and the fair market value of any
supplies, equipment, or services provided by the Secretary. The
Secretary shall, for the payment of expenses incurred in
complying with such request, expend the amounts withheld.
SEC. 2667. [300FF-67] USE OF FUNDS.
Counseling programs carried out under this part--
(1) shall not be designed to promote or encourage,
directly, intravenous drug abuse or sexual activity,
homosexual or heterosexual;
(2) shall be designed to reduce exposure to and
transmission of HIV/AIDS by providing accurate
information;
(3) shall provide information on the health risks
of promiscuous sexual activity and intravenous drug
abuse; amd
(4) shall provide information on the transmission
and prevention of hepatitis A, B, and C, including
education about the availability of hepatitis A and B
vaccines and assisting patients in identifying
vaccination sites.
PART D--WOMEN, INFANTS, CHILDREN, AND YOUTH
SEC. 2671. [300FF-71] GRANTS FOR COORDINATED SERVICES AND ACCESS TO
RESEARCH FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall award grants to public and nonprofit
private entities (including a health facility operated by or
pursuant to a contract with the Indian Health Service) for the
purpose of providing family-centered care involving outpatient
or ambulatory care (directly or through contracts or memoranda
of understanding) for women, infants, children, and youth with
HIV/AIDS.
(b) Additional Services for Patients and Families.--Funds
provided under grants awarded under subsection (a) may be used
for the following support services:
(1) Family-centered care including case management.
(2) Referrals for additional services including--
(A) referrals for inpatient hospital
services, treatment for substance abuse, and
mental health services; and
(B) referrals for other social and support
services, as appropriate.
(3) Additional services necessary to enable the
patient and the family to participate in the program
established by the applicant pursuant to such
subsection including services designed to recruit and
retain youth with HIV.
(4) The provision of information and education on
opportunities to participate in HIV/AIDS-related
clinical research.
(c) Coordination With Other Entities.--A grant awarded
under subsection (a) may be made only if the applicant provides
an agreement that includes the following:
(1) The applicant will coordinate activities under
the grant with other providers of health care services
under this Act, and under title V of the Social
Security Act, including programs promoting the
reduction and elimination of risk of HIV/AIDS for
youth.
(2) The applicant will participate in the statewide
coordinated statement of need under part B (where it
has been initiated by the public health agency
responsible for administering grants under part B) and
in revisions of such statement.
(3) The applicant will every 2 years submit to the
lead State agency under section 2617(b)(4) audits
regarding funds expended in accordance with this title
and shall include necessary client-level data to
complete unmet need calculations and Statewide
coordinated statements of need process.
(d) Administration; Application.--A grant may only be
awarded to an entity under subsection (a) if an application for
the grant is submitted to the Secretary and the application is
in such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary
determines to be necessary to carry out this section. Such
application shall include the following:
(1) Information regarding how the expected
expenditures of the grant are related to the planning
process for localities funded under part A (including
the planning process outlined in section 2602) and for
States funded under part B (including the planning
process outlined in section 2617(b)).
(2) A specification of the expected expenditures
and how those expenditures will improve overall patient
outcomes, as outlined as part of the State plan (under
section 2617(b)) or through additional outcome
measures.
(e) Annual Review of Programs; Evaluations.--
(1) Review regarding access to and participation in
programs.--With respect to a grant under subsection (a)
for an entity for a fiscal year, the Secretary shall,
not later than 180 days after the end of the fiscal
year, provide for the conduct and completion of a
review of the operation during the year of the program
carried out under such subsection by the entity. The
purpose of such review shall be the development of
recommendations, as appropriate, for improvements in
the following:
(A) Procedures used by the entity to
allocate opportunities and services under
subsection (a) among patients of the entity who
are women, infants, children, or youth.
(B) Other procedures or policies of the
entity regarding the participation of such
individuals in such program.
(2) Evaluations.----The Secretary shall, directly
or through contracts with public and private entities,
provide for evaluations of programs carried out
pursuant to subsection (a).
(f) Administrative Expenses.--
(1) Limitation.--A grantee may not use more than 10
percent of amounts received under a grant awarded under
this section for administrative expenses.
(2) Clinical quality management program.--A grantee
under this section shall implement a clinical quality
management program to assess the extent to which HIV
health services provided to patients under the grant
are consistent with the most recent Public Health
Service guidelines for the treatment of HIV/AIDS and
related opportunistic infection, and as applicable, to
develop strategies for ensuring that such services are
consistent with the guidelines for improvement in the
access to and quality of HIV health services.
(g) Training and Technical Assistance.--From the amounts
appropriated under subsection (j) for a fiscal year, the
Secretary may use not more than 5 percent to provide, directly
or through contracts with public and private entities (which
may include grantees under subsection (a)), training and
technical assistance to assist applicants and grantees under
subsection (a) in complying with the requirements of this
section.
(h) Definitions.--In this section:
(1) Administrative expenses.--The term
``administrative expenses'' means funds that are to be
used by grantees for grant management and monitoring
activities, including costs related to any staff or
activity unrelated to services or indirect costs.
(2) Indirect costs.--The term ``indirect costs''
means costs included in a Federally negotiated indirect
rate.
(3) Services.--The term ``services'' means--
(A) services that are provided to clients
to meet the goals and objectives of the program
under this section, including the provision of
professional, diagnostic, and therapeutic
services by a primary care provider or a
referral to and provision of specialty care;
and
(B) services that sustain program activity
and contribute to or help improve services
under subparagraph (A).
(i) Application to Primary Care Services.--Nothing in this
part shall be construed as requiring funds under this part to
be used for primary care services when payments are available
for such services from other sources (including under titles
XVIII, XIX, and XXI of the Social Security Act).
(j) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated, $71,800,000 for each of the fiscal years 2007
through 2009, $75,390,000 for fiscal year 2010, $79,160,000 for
fiscal year 2011, $83,117,000 for fiscal year 2012, and
$87,273,000 for fiscal year 2013.
PART E--GENERAL PROVISIONS
SEC. 2681. [300FF-81] COORDINATION.
(a) Requirement.--The Secretary shall ensure that the
Health Resources and Services Administration, the Centers for
Disease Control and Prevention, the Substance Abuse and Mental
Health Services Administration, and the Centers for Medicare &
Medicaid Services coordinate the planning, funding, and
implementation of Federal HIV programs (including all minority
AIDS initiatives of the Public Health Service, including under
section 2693) to enhance the continuity of care and prevention
services for individuals with HIV/AIDS or those at risk of such
disease. The Secretary shall consult with other Federal
agencies, including the Department of Veterans Affairs, as
needed and utilize planning information submitted to such
agencies by the States and entities eligible for assistance
under this title.
(b) Report.--The Secretary shall biennially prepare and
submit to the appropriate committees of the Congress a report
concerning the coordination efforts at the Federal, State, and
local levels described in this section, including a description
of Federal barriers to HIV program integration and a strategy
for eliminating such barriers and enhancing the continuity of
care and prevention services for individuals with HIV/AIDS or
those at risk of such disease.
(c) Integration by State.--As a condition of receipt of
funds under this title, a State shall provide assurances to the
Secretary that health support services funded under this title
will be integrated with other such services, that programs will
be coordinated with other available programs (including
Medicaid), and that the continuity of care and prevention
services of individuals with HIV/AIDS is enhanced.
(d) Integration by Local or Private Entities.--As a
condition of receipt of funds under this title, a local
government or private nonprofit entity shall provide assurances
to the Secretary that services funded under this title will be
integrated with other such services, that programs will be
coordinated with other available programs (including Medicaid),
and that the continuity of care and prevention services of
individuals with HIV is enhanced.
SEC. 2682. [300FF-82] AUDITS.
(a) In General.--For fiscal year 2009, and each subsequent
fiscal year, the Secretary may reduce the amounts of grants
under this title to a State or political subdivision of a State
for a fiscal year if, with respect to such grants for the
second preceding fiscal year, the State or subdivision fails to
prepare audits in accordance with the procedures of section
7502 of title 31, United States Code. The Secretary shall
annually select representative samples of such audits, prepare
summaries of the selected audits, and submit the summaries to
the Congress.
(b) Posting on the Internet.--All audits that the Secretary
receives from the State lead agency under section 2617(b)(4)
shall be posted, in their entirety, on the Internet website of
the Health Resources and Services Administration.
SEC. 2683. [300FF-83] PUBLIC HEALTH EMERGENCY.
(a) In General.--In an emergency area and during an
emergency period, the Secretary shall have the authority to
waive such requirements of this title to improve the health and
safety of those receiving care under this title and the general
public, except that the Secretary may not expend more than 5
percent of the funds allocated under this title for sections
2620 and section 2603(b).
(b) Emergency Area and Emergency Period.--In this section:
(1) Emergency area.--The term ``emergency area''
means a geographic area in which there exists--
(A) an emergency or disaster declared by
the President pursuant to the National
Emergencies Act or the Robert T. Stafford
Disaster Relief and Emergency Assistance Act;
or
(B) a public health emergency declared by
the Secretary pursuant to section 319.
(2) Emergency period.--The term ``emergency
period'' means the period in which there exists--
(A) an emergency or disaster declared by
the President pursuant to the National
Emergencies Act or the Robert T. Stafford
Disaster Relief and Emergency Assistance Act;
or
(B) a public health emergency declared by
the Secretary pursuant to section 319.
(c) Unobligated Funds.--If funds under a grant under this
section are not expended for an emergency in the fiscal year in
which the emergency is declared, such funds shall be returned
to the Secretary for reallocation under sections 2603(b) and
2620.
SEC. 2684. [300FF-84] PROHIBITION ON PROMOTION OF CERTAIN ACTIVITIES.
None of the funds appropriated under this title shall be
used to fund AIDS programs, or to develop materials, designed
to promote or encourage, directly, intravenous drug use or
sexual activity, whether homosexual or heterosexual. Funds
authorized under this title may be used to provide medical
treatment and support services for individuals with HIV.
SEC. 2685. [300FF-85] PRIVACY PROTECTIONS.
(a) In General.--The Secretary shall ensure that any
information submitted to, or collected by, the Secretary under
this title excludes any personally identifiable information.
(b) Definition.--In this section, the term ``personally
identifiable information'' has the meaning given such term
under the regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996.
SEC. 2686. [300FF-86] GAO REPORT.
The Comptroller General of the Government Accountability
Office shall, not less than 1 year after the date of enactment
of the Ryan White HIV/AIDS Treatment Extension Act of 2009,
submit to the appropriate committees of Congress a report
describing Minority AIDS Initiative activities across the
Department of Health and Human Services, including programs
under this title and programs at the Centers for Disease
Control and Prevention, the Substance Abuse and Mental Health
Services Administration, and other departmental agencies. Such
report shall include a history of program activities within
each relevant agency and a description of activities conducted,
people served and types of grantees funded, and shall collect
and describe best practices in community outreach and capacity-
building of community based organizations serving the
communities that are disproportionately affected by HIV/AIDS.
SEC. 2687. [300FF-87] SEVERITY OF NEED INDEX.
(a) Development of Index.--Not later than September 30,
2008, the Secretary shall develop and submit to the appropriate
committees of Congress a severity of need index in accordance
with subsection (c).
(b) Definition of Severity of Need Index.--In this section,
the term ``severity of need index'' means the index of the
relative needs of individuals within a State or area, as
identified by a number of different factors, and is a factor or
set of factors that is multiplied by the number of living HIV/
AIDS cases in a State or area, providing different weights to
those cases based on needs. Such factors or set of factors may
be different for different components of the provisions under
this title.
(c) Requirements for Secretarial Submission.--When the
Secretary submits to the appropriate committees of Congress the
severity of need index under subsection (a), the Secretary
shall provide the following:
(1) Methodology for and rationale behind developing
the severity of need index, including information
related to the field testing of the severity of need
index.
(2) An independent contractor analysis of
activities carried out under paragraph (1).
(3) Information regarding the process by which the
Secretary received community input regarding the
application and development of the severity of need
index.
(d) Annual Reports.--If the Secretary fails to submit the
severity of need index under subsection (a) in either of fiscal
years 2007 or 2008, the Secretary shall prepare and submit to
the appropriate committees of Congress a report for such fiscal
year--
(1) that updates progress toward having client
level data;
(2) that updates the progress toward having a
severity of need index, including information related
to the methodology and process for obtaining community
input; and
(3) that, as applicable, states whether the
Secretary could develop a severity of need index before
fiscal year 2009.
SEC. 2688. [300FF-87A] NATIONAL HIV/AIDS TESTING GOAL.
(a) In General.--Not later than January 1, 2010, the
Secretary shall establish a national HIV/AIDS testing goal of
5,000,000 tests for HIV/AIDS annually through federally-
supported HIV/AIDS prevention, treatment, and care programs,
including programs under this title and other programs
administered by the Centers for Disease Control and Prevention.
(b) Annual Report.--Not later than January 1, 2011, and
annually thereafter, the Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall submit
to Congress a report describing, with regard to the preceding
12-month reporting period--
(1) whether the testing goal described in
subsection (a) has been met;
(2) the total number of individuals tested through
federally-supported and other HIV/AIDS prevention,
treatment, and care programs in each State;
(3) the number of individuals who--
(A) prior to such 12-month period, were
unaware of their HIV status; and
(B) through federally-supported and other
HIV/AIDS prevention, treatment, and care
programs, were diagnosed and referred into
treatment and care during such period;
(4) any barriers, including State laws and
regulations, that the Secretary determines to be a
barrier to meeting the testing goal described in
subsection (a);
(5) the amount of funding the Secretary determines
necessary to meet the annual testing goal in the
following 12 months and the amount of Federal funding
expended to meet the testing goal in the prior 12-month
period; and
(6) the most cost-effective strategies for
identifying and diagnosing individuals who were unaware
of their HIV status, including voluntary testing with
pre-test counseling, routine screening including opt-
out testing, partner counseling and referral services,
and mass media campaigns.
(c) Review of Program Effectiveness.--Not later than 1 year
after the date of enactment of this section, the Secretary, in
consultation with the Director of the Centers for Disease
Control and Prevention, shall submit a report to Congress based
on a comprehensive review of each of the programs and
activities conducted by the Centers for Disease Control and
Prevention as part of the Domestic HIV/AIDS Prevention
Activities, including the following:
(1) The amount of funding provided for each program
or activity.
(2) The primary purpose of each program or
activity.
(3) The annual goals for each program or activity.
(4) The relative effectiveness of each program or
activity with relation to the other programs and
activities conducted by the Centers for Disease Control
and Prevention, based on the--
(A) number of previously undiagnosed
individuals with HIV/AIDS made aware of their
status and referred into the appropriate
treatment;
(B) amount of funding provided for each
program or activity compared to the number of
undiagnosed individuals with HIV/AIDS made
aware of their status;
(C) program's contribution to the National
HIV/AIDS testing goal; and
(D) progress made toward the goals
described in paragraph (3).
(5) Recommendations if any to Congress on ways to
allocate funding for domestic HIV/AIDS prevention
activities and programs in order to achieve the
National HIV/AIDS testing goal.
(d) Coordination With Other Federal Activities.--In
pursuing the National HIV/AIDS testing goal, the Secretary,
where appropriate, shall consider and coordinate with other
national strategies conducted by the Federal Government to
address HIV/AIDS.
SEC. 2689. [300FF-88] DEFINITIONS.
For purposes of this title:
(1) AIDS.--The term ``AIDS'' means acquired immune
deficiency syndrome.
(2) Co-occurring conditions.--The term ``co-
occurring conditions'' means one or more adverse health
conditions in an individual with HIV/AIDS, without
regard to whether the individual has AIDS and without
regard to whether the conditions arise from HIV.
(3) Counseling.--The term ``counseling'' means such
counseling provided by an individual trained to provide
such counseling.
(4) Family-centered care.--The term ``family-
centered care'' means the system of services described
in this title that is targeted specifically to the
special needs of infants, children, women and families.
Family-centered care shall be based on a partnership
between parents, professionals, and the community
designed to ensure an integrated, coordinated,
culturally sensitive, and community-based continuum of
care for children, women, and families with HIV/AIDS.
(5) Families with hiv/aids.--The term ``families
with HIV/AIDS'' means families in which one or more
members have HIV/AIDS.
(6) HIV.--The term ``HIV'' means infection with
the human immunodeficiency virus.
(7) HIV/AIDS.--
(A) In general.--The term ``HIV/AIDS''
means HIV, and includes AIDS and any condition
arising from AIDS.
(B) Counting of cases.--The term ``living
cases of HIV/AIDS'', with respect to the
counting of cases in a geographic area during a
period of time, means the sum of--
(i) the number of living non-AIDS
cases of HIV in the area; and
(ii) the number of living cases of
AIDS in the area.
(C) Non-aids cases.--The term ``non-AIDS'',
with respect to a case of HIV, means that the
individual involved has HIV but does not have
AIDS.
(8) Human immunodeficiency virus.--The term ``human
immunodeficiency virus'' means the etiologic agent for
AIDS.
(9) Official poverty line.--The term ``official
poverty line'' means the poverty line established by
the Director of the Office of Management and Budget and
revised by the Secretary in accordance with section
673(2) of the Omnibus Budget Reconciliation Act of
1981.
(10) Person.--The term ``person'' includes one or
more individuals, governments (including the Federal
Government and the governments of the States),
governmental agencies, political subdivisions, labor
unions, partnerships, associations, corporations, legal
representatives, mutual companies, joint-stock
companies, trusts, unincorporated organizations,
receivers, trustees, and trustees in cases under title
11, United States Code.
(11) State.--
(A) In general.--The term ``State'' means
each of the 50 States, the District of
Columbia, and each of the territories.
(B) Territories.--The term ``territory''
means each of American Samoa, Guam, the
Commonwealth of Puerto Rico, the Commonwealth
of the Northern Mariana Islands, the Virgin
Islands, the Republic of the Marshall Islands,
the Federated States of Micronesia, and Palau.
(12) Youth with hiv.--The term ``youth with HIV''
means individuals who are 13 through 24 years old and
who have HIV/AIDS.
PART F--DEMONSTRATION AND TRAINING
Subpart I--Special Projects of National Significance
SEC. 2691. [300FF-101] SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE.
(a) In General.--Of the amount appropriated under each of
parts A, B, C, and D for each fiscal year, the Secretary shall
use the greater of $20,000,000 or an amount equal to 3 percent
of such amount appropriated under each such part, but not to
exceed $25,000,000, to administer special projects of national
significance to--
(1) quickly respond to emerging needs of
individuals receiving assistance under this title; and
(2) to fund special programs to develop a standard
electronic client information data system to improve
the ability of grantees under this title to report
client-level data to the Secretary.
(b) Grants.--The Secretary shall award grants under
subsection (a) to entities eligible for funding under parts A,
B, C, and D based on--
(1) whether the funding will promote obtaining
client level data as it relates to the creation of a
severity of need index, including funds to facilitate
the purchase and enhance the utilization of qualified
health information technology systems;
(2) demonstrated ability to create and maintain a
qualified health information technology system;
(3) the potential replicability of the proposed
activity in other similar localities or nationally;
(4) the demonstrated reliability of the proposed
qualified health information technology system across a
variety of providers, geographic regions, and clients;
and
(5) the demonstrated ability to maintain a safe and
secure qualified health information system; or
(6) newly emerging needs of individuals receiving
assistance under this title.
(c) Coordination.--The Secretary may not make a grant under
this section unless the applicant submits evidence that the
proposed program is consistent with the statewide coordinated
statement of need, and the applicant agrees to participate in
the ongoing revision process of such statement of need.
(d) Privacy Protection.--The Secretary may not make a grant
under this section for the development of a qualified health
information technology system unless the applicant provides
assurances to the Secretary that the system will, at a minimum,
comply with the privacy regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996.
(e) Replication.--The Secretary shall make information
concerning successful models or programs developed under this
part available to grantees under this title for the purpose of
coordination, replication, and integration. To facilitate
efforts under this subsection, the Secretary may provide for
peer-based technical assistance for grantees funded under this
part.
Subpart II--AIDS Education and Training Centers
SEC. 2692. [300FF-111] HIV/AIDS COMMUNITIES, SCHOOLS, AND CENTERS.
(a) Schools; Centers.--
(1) In general.--The Secretary may make grants and
enter into contracts to assist public and nonprofit
private entities and schools and academic health
science centers in meeting the costs of projects--
(A) to train health personnel, including
practitioners in programs under this title and
other community providers, in the diagnosis,
treatment, and prevention of HIV/AIDS,
including the prevention of the perinatal
transmission of the disease, including measures
for the prevention and treatment of
opportunistic infections, and including (as
applicable to the type of health professional
involved), prenatal and other gynecological
care for women with HIV/AIDS;
(B) to train the faculty of schools of, and
graduate departments or programs of, medicine,
nursing, osteopathic medicine, dentistry,
public health, allied health, and mental health
practice to teach health professions students
to provide for the health care needs of
individuals with HIV/AIDS;
(C) to develop and disseminate curricula
and resource materials relating to the care and
treatment of individuals with such disease and
the prevention of the disease among individuals
who are at risk of contracting the disease; and
(D) to develop protocols for the medical
care of women with HIV/AIDS, including prenatal
and other gynecological care for such women.
(2) Preference in making grants.--In making grants
under paragraph (1), the Secretary shall give
preference to qualified projects which will--
(A) train, or result in the training of,
health professionals who will provide treatment
for minority individuals and Native Americans
with HIV/AIDS and other individuals who are at
high risk of contracting such disease;
(B) train, or result in the training of,
minority health professionals and minority
allied health professionals to provide
treatment for individuals with such disease;
and
(C) train or result in the training of
health professionals and allied health
professionals to provide treatment for
hepatitis B or C co-infected individuals.
(3) Application.--No grant or contract may be made
under paragraph (1) unless an application is submitted
to the Secretary in such form, at such time, and
containing such information, as the Secretary may
prescribe.
(b) Dental Schools.--
(1) In general.--
(A) Grants.--The Secretary may make grants
to dental schools and programs described in
subparagraph (B) to assist such schools and
programs with respect to oral health care to
patients with HIV/AIDS.
(B) Eligible applicants.--For purposes of
this subsection, the dental schools and
programs referred to in this subparagraph are
dental schools and programs that were described
in section 777(b)(4)(B) as such section was in
effect on the day before the date of the
enactment of the Health Professions Education
Partnerships Act of 1998 (Public Law 105-392)
and in addition dental hygiene programs that
are accredited by the Commission on Dental
Accreditation.
(2) Application.--Each dental school or program
described in section \1\ the section referred to in
paragraph (1)(B) may annually submit an application
documenting the unreimbursed costs of oral health care
provided to patients with HIV/AIDS by that school or
hospital during the prior year.
---------------------------------------------------------------------------
\1\ So in law. See section 402(b)(2) of Public Law 106-345 (114
Stat. 1349).
---------------------------------------------------------------------------
(3) Distribution.--The Secretary shall distribute
the available funds among all eligible applicants,
taking into account the number of patients with HIV/
AIDS served and the unreimbursed oral health care costs
incurred by each institution as compared with the total
number of patients served and costs incurred by all
eligible applicants.
(4) Maintenance of effort.--The Secretary shall not
make a grant under this subsection if doing so would
result in any reduction in State funding allotted for
such purposes.
(5) Community-based care.--The Secretary may make
grants to dental schools and programs described in
paragraph (1)(B) that partner with community-based
dentists to provide oral health care to patients with
HIV/AIDS in unserved areas. Such partnerships shall
permit the training of dental students and residents
and the participation of community dentists as adjunct
faculty.
(c) Authorization of Appropriations.--
(1) Schools; centers.--For the purpose of awarding
grants under subsection (a), there are authorized to be
appropriated $34,700,000 for each of the fiscal years
2007 through 2009, $36,535,000 for fiscal year 2010,
$38,257,000 for fiscal year 2011, $40,170,000 for
fiscal year 2012, and $42,178,000 for fiscal year 2013.
(2) Dental schools.--For the purpose of awarding
grants under subsection (b), there are authorized to be
appropriated $13,000,000 for each of the fiscal years
2007 through 2009, $13,650,000 for fiscal year 2010,
$14,333,000 for fiscal year 2011, $15,049,000 for
fiscal year 2012, and $15,802,000 for fiscal year 2013.
Subpart III--Minority AIDS Initiative
SEC. 2693. [300FF-121] MINORITY AIDS INITIATIVE.
(a) In General.--For the purpose of carrying out activities
under this section to evaluate and address the disproportionate
impact of HIV/AIDS on, and the disparities in access,
treatment, care, and outcomes for, racial and ethnic minorities
(including African Americans, Alaska Natives, Latinos, American
Indians, Asian Americans, Native Hawaiians, and Pacific
Islanders), there are authorized to be appropriated
$131,200,000 for fiscal year 2007, $135,100,000 for fiscal year
2008, $139,100,000 for fiscal year 2009, $146,055,000 for
fiscal year 2010, $153,358,000 for fiscal year 2011,
$161,026,000 for fiscal year 2012, and $169,077,000 for fiscal
year 2013. The Secretary shall develop a formula for the
awarding of grants under subsections (b)(1)(A) and (b)(1)(B)
that ensures that funding is provided based on the distribution
of populations disproportionately impacted by HIV/AIDS.
(b) Certain Activities.--
(1) In general.--In carrying out the purpose
described in subsection (a), the Secretary shall
provide for--
(A) emergency assistance under part A;
(B) care grants under part B;
(C) early intervention services under part
C;
(D) services through projects for HIV-
related care under part D; and
(E) activities through education and
training centers under section 2692.
(2) Allocations among activities.--Activities under
paragraph (1) shall be carried out by the Secretary in
accordance with the following:
(A) For supplemental grants to improve HIV-
related health outcomes to reduce existing
racial and ethnic health disparities, the
Secretary shall, of the amount appropriated
under subsection (a) for a fiscal year, reserve
the following, as applicable:
(i) For fiscal year 2007,
$43,800,000.
(ii) For fiscal year 2008,
$45,400,000.
(iii) For fiscal year 2009,
$47,100,000.
(iv) For fiscal year 2010,
$46,738,000.
(v) For fiscal year 2011,
$49,075,000.
(vi) For fiscal year 2012,
$51,528,000.
(vii) For fiscal year 2013,
$54,105,000.
(B) For grants used for supplemental
support education and outreach services to
increase the number of eligible racial and
ethnic minorities who have access to treatment
through the program under section 2616 for
therapeutics, the Secretary shall, of the
amount appropriated for a fiscal year under
subsection (a), reserve the following, as
applicable:
(i) For fiscal year 2007,
$7,000,000.
(ii) For fiscal year 2008,
$7,300,000.
(iii) For fiscal year 2009,
$7,500,000.
(iv) For fiscal year 2010,
$8,763,000.
(v) For fiscal year 2011,
$9,202,000.
(vi) For fiscal year 2012,
$9,662,000.
(vii) For fiscal year 2013,
$10,145,000.
(C) For planning grants, capacity-building
grants, and services grants to health care
providers who have a history of providing
culturally and linguistically appropriate care
and services to racial and ethnic minorities,
the Secretary shall, of the amount appropriated
for a fiscal year under subsection (a), reserve
the following, as applicable:
(i) For fiscal year 2007,
$53,400,000.
(ii) For fiscal year 2008,
$55,400,000.
(iii) For fiscal year 2009,
$57,400,000.
(iv) For fiscal year 2010,
$61,343,000.
(v) For fiscal year 2011,
$64,410,000.
(vi) For fiscal year 2012,
$67,631,000.
(vii) For fiscal year 2013,
$71,012,000.
(D) For eliminating racial and ethnic
disparities in the delivery of comprehensive,
culturally and linguistically appropriate care
services for HIV disease for women, infants,
children, and youth, the Secretary shall, of
the amount appropriated under subsection (a),
reserve the following, as applicable:
(i) For fiscal year 2010,
$20,448,000.
(ii) For fiscal year 2011,
$21,470,000.
(iii) For fiscal year 2012,
$22,543,000.
(iv) For fiscal year 2013,
$23,671,000.
(E) For increasing the training capacity of
centers to expand the number of health care
professionals with treatment expertise and
knowledge about the most appropriate standards
of HIV disease-related treatments and medical
care for racial and ethnic minority adults,
adolescents, and children with HIV disease, the
Secretary shall, of the amount appropriated
under subsection (a), reserve the following, as
applicable:
(i) For fiscal year 2010,
$8,763,000.
(ii) For fiscal year 2011,
$9,201,000.
(iii) For fiscal year 2012,
$9,662,000.
(iv) For fiscal year 2013,
$10,144,000.
(c) Consistency With Prior Program.--With respect to the
purpose described in subsection (a), the Secretary shall carry
out this section consistent with the activities carried out
under this title by the Secretary pursuant to the Departments
of Labor, Health and Human Services, and Education, and Related
Agencies Appropriations Act, 2002 (Public Law 107-116).
(d) Synchronization of Minority AIDS Initiative.--For
fiscal year 2010 and each subsequent fiscal year, the Secretary
shall incorporate and synchronize the schedule of application
submissions and funding availability under this section with
the schedule of application submissions and funding
availability under the corresponding provisions of this title
XXVI as follows:
(1) The schedule for carrying out subsection
(b)(1)(A) shall be the same as the schedule applicable
to emergency assistance under part A.
(2) The schedule for carrying out subsection
(b)(1)(B) shall be the same as the schedule applicable
to care grants under part B.
(3) The schedule for carrying out subsection
(b)(1)(C) shall be the same as the schedule applicable
to grants for early intervention services under part C.
(4) The schedule for carrying out subsection
(b)(1)(D) shall be the same as the schedule applicable
to grants for services through projects for HIV-related
care under part D.
(5) The schedule for carrying out subsection
(b)(1)(E) shall be the same as the schedule applicable
to grants and contracts for activities through
education and training centers under section 2692.
PART G--NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES
SEC. 2695. [300FF-131] INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT
TO NOTIFICATION REQUIREMENTS.
(a) In General.--Not later than 180 days after the date of
the enactment of this part, the Secretary shall complete the
development of--
(1) a list of potentially life-threatening
infectious diseases, including emerging infectious
diseases, to which emergency response employees may be
exposed in responding to emergencies;
(2) guidelines describing the circumstances in
which such employees may be exposed to such diseases,
taking into account the conditions under which
emergency response is provided; and
(3) guidelines describing the manner in which
medical facilities should make determinations for
purposes of section 2695B(d).
(b) Specification of Airborne Infectious Diseases.--The
list developed by the Secretary under subsection (a)(1) shall
include a specification of those infectious diseases on the
list that are routinely transmitted through airborne or
aerosolized means.
(c) Dissemination.--The Secretary shall--
(1) transmit to State public health officers copies
of the list and guidelines developed by the Secretary
under subsection (a) with the request that the officers
disseminate such copies as appropriate throughout the
States; and
(2) make such copies available to the public.
SEC. 2695A. [300FF-132] ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE
INFECTIOUS DISEASES IN VICTIMS ASSISTED.
(a) Routine Notification of Designated Officer.--
(1) Determination by treating facility.--If a
victim of an emergency is transported by emergency
response employees to a medical facility and the
medical facility makes a determination that the victim
has an airborne infectious disease, the medical
facility shall notify the designated officer of the
emergency response employees who transported the victim
to the medical facility of the determination.
(2) Determination by facility ascertaining cause of
death.--If a victim of an emergency is transported by
emergency response employees to a medical facility and
the victim dies at or before reaching the medical
facility, the medical facility ascertaining the cause
of death shall notify the designated officer of the
emergency response employees who transported the victim
to the initial medical facility of any determination by
the medical facility that the victim had an airborne
infectious disease.
(b) Requirement of Prompt Notification.--With respect to a
determination described in paragraph (1) or (2) of subsection
(a), the notification required in each of such paragraphs shall
be made as soon as is practicable, but not later than 48 hours
after the determination is made.
SEC. 2695B. [300FF-133] REQUEST FOR NOTIFICATION WITH RESPECT TO
VICTIMS ASSISTED.
(a) Initiation of Process by Employee.--If an emergency
response employee believes that the employee may have been
exposed to an infectious disease by a victim of an emergency
who was transported to a medical facility as a result of the
emergency, and if the employee attended, treated, assisted, or
transported the victim pursuant to the emergency, then the
designated officer of the employee shall, upon the request of
the employee, carry out the duties described in subsection (b)
regarding a determination of whether the employee may have been
exposed to an infectious disease by the victim.
(b) Initial Determination by Designated Officer.--The
duties referred to in subsection (a) are that--
(1) the designated officer involved collect the
facts relating to the circumstances under which, for
purposes of subsection (a), the employee involved may
have been exposed to an infectious disease; and
(2) the designated officer evaluate such facts and
make a determination of whether, if the victim involved
had any infectious disease included on the list issued
under paragraph (1) of section 2695(a), the employee
would have been exposed to the disease under such
facts, as indicated by the guidelines issued under
paragraph (2) of such section.
(c) Submission of Request to Medical Facility.--
(1) In general.--If a designated officer makes a
determination under subsection (b)(2) that an emergency
response employee may have been exposed to an
infectious disease, the designated officer shall submit
to the medical facility to which the victim involved
was transported a request for a response under
subsection (d) regarding the victim of the emergency
involved.
(2) Form of request.--A request under paragraph (1)
shall be in writing and be signed by the designated
officer involved, and shall contain a statement of the
facts collected pursuant to subsection (b)(1).
(d) Evaluation and Response Regarding Request to Medical
Facility.--
(1) In general.--If a medical facility receives a
request under subsection (c), the medical facility
shall evaluate the facts submitted in the request and
make a determination of whether, on the basis of the
medical information possessed by the facility regarding
the victim involved, the emergency response employee
was exposed to an infectious disease included on the
list issued under paragraph (1) of section 2695(a), as
indicated by the guidelines issued under paragraph (2)
of such section.
(2) Notification of exposure.--If a medical
facility makes a determination under paragraph (1) that
the emergency response employee involved has been
exposed to an infectious disease, the medical facility
shall, in writing, notify the designated officer who
submitted the request under subsection (c) of the
determination.
(3) Finding of no exposure.--If a medical facility
makes a determination under paragraph (1) that the
emergency response employee involved has not been
exposed to an infectious disease, the medical facility
shall, in writing, inform the designated officer who
submitted the request under subsection (c) of the
determination.
(4) Insufficient information.--
(A) If a medical facility finds in
evaluating facts for purposes of paragraph (1)
that the facts are insufficient to make the
determination described in such paragraph, the
medical facility shall, in writing, inform the
designated officer who submitted the request
under subsection (c) of the insufficiency of
the facts.
(B)(i) If a medical facility finds in
making a determination under paragraph (1) that
the facility possesses no information on
whether the victim involved has an infectious
disease included on the list under section
2695(a), the medical facility shall, in
writing, inform the designated officer who
submitted the request under subsection (c) of
the insufficiency of such medical information.
(ii) If after making a response under
clause (i) a medical facility determines that
the victim involved has an infectious disease,
the medical facility shall make the
determination described in paragraph (1) and
provide the applicable response specified in
this subsection.
(e) Time for Making Response.--After receiving a request
under subsection (c) (including any such request resubmitted
under subsection (g)(2)), a medical facility shall make the
applicable response specified in subsection (d) as soon as is
practicable, but not later than 48 hours after receiving the
request.
(f) Death of Victim of Emergency.--
(1) Facility ascertaining cause of death.--If a
victim described in subsection (a) dies at or before
reaching the medical facility involved, and the medical
facility receives a request under subsection (c), the
medical facility shall provide a copy of the request to
the medical facility ascertaining the cause of death of
the victim, if such facility is a different medical
facility than the facility that received the original
request.
(2) Responsibility of facility.--Upon the receipt
of a copy of a request for purposes of paragraph (1),
the duties otherwise established in this part regarding
medical facilities shall apply to the medical facility
ascertaining the cause of death of the victim in the
same manner and to the same extent as such duties apply
to the medical facility originally receiving the
request.
(g) Assistance of Public Health Officer.--
(1) Evaluation of response of medical facility
regarding insufficient facts.--
(A) In the case of a request under
subsection (c) to which a medical facility has
made the response specified in subsection
(d)(4)(A) regarding the insufficiency of facts,
the public health officer for the community in
which the medical facility is located shall
evaluate the request and the response, if the
designated officer involved submits such
documents to the officer with the request that
the officer make such an evaluation.
(B) As soon as is practicable after a
public health officer receives a request under
subparagraph (A), but not later than 48 hours
after receipt of the request, the public health
officer shall complete the evaluation required
in such paragraph and inform the designated
officer of the results of the evaluation.
(2) Findings of evaluation.--
(A) If an evaluation under paragraph (1)(A)
indicates that the facts provided to the
medical facility pursuant to subsection (c)
were sufficient for purposes of determinations
under subsection (d)(1)--
(i) the public health officer
shall, on behalf of the designated
officer involved, resubmit the request
to the medical facility; and
(ii) the medical facility shall
provide to the designated officer the
applicable response specified in
subsection (d).
(B) If an evaluation under paragraph (1)(A)
indicates that the facts provided in the
request to the medical facility were
insufficient for purposes of determinations
specified in subsection (c)--
(i) the public health officer shall
provide advice to the designated
officer regarding the collection and
description of appropriate facts; and
(ii) if sufficient facts are
obtained by the designated officer--
(I) the public health
officer shall, on behalf of the
designated officer involved,
resubmit the request to the
medical facility; and
(II) the medical facility
shall provide to the designated
officer the appropriate
response under subsection (c).
SEC. 2695C. [300FF-134] PROCEDURES FOR NOTIFICATION OF EXPOSURE.
(a) Contents of Notification to Officer.--In making a
notification required under section 2695A or section
2695B(d)(2), a medical facility shall provide--
(1) the name of the infectious disease involved;
and
(2) the date on which the victim of the emergency
involved was transported by emergency response
employees to the medical facility involved.
(b) Manner of Notification.--If a notification under
section 2695A or section 2695B(d)(2) is mailed or otherwise
indirectly made--
(1) the medical facility sending the notification
shall, upon sending the notification, inform the
designated officer to whom the notification is sent of
the fact that the notification has been sent; and
(2) such designated officer shall, not later than
10 days after being informed by the medical facility
that the notification has been sent, inform such
medical facility whether the designated officer has
received the notification.
SEC. 2695D. [300FF-135] NOTIFICATION OF EMPLOYEE.
(a) In General.--After receiving a notification for
purposes of section 2695A or 2695B(d)(2), a designated officer
of emergency response employees shall, to the extent
practicable, immediately notify each of such employees who--
(1) responded to the emergency involved; and
(2) as indicated by guidelines developed by the
Secretary, may have been exposed to an infectious
disease.
(b) Certain Contents of Notification to Employee.--A
notification under this subsection to an emergency response
employee shall inform the employee of--
(1) the fact that the employee may have been
exposed to an infectious disease and the name of the
disease involved;
(2) any action by the employee that, as indicated
by guidelines developed by the Secretary, is medically
appropriate; and
(3) if medically appropriate under such criteria,
the date of such emergency.
(c) Responses Other Than Notification of Exposure.--After
receiving a response under paragraph (3) or (4) of subsection
(d) of section 2695B, or a response under subsection (g)(1) of
such section, the designated officer for the employee shall, to
the extent practicable, immediately inform the employee of the
response.
SEC. 2695E. [300FF-136] SELECTION OF DESIGNATED OFFICERS.
(a) In General.--For the purposes of receiving
notifications and responses and making requests under this part
on behalf of emergency response employees, the public health
officer of each State shall designate 1 official or officer of
each employer of emergency response employees in the State.
(b) Preference in Making Designations.--In making the
designations required in subsection (a), a public health
officer shall give preference to individuals who are trained in
the provision of health care or in the control of infectious
diseases.
SEC. 2695F. [300FF-137] LIMITATION WITH RESPECT TO DUTIES OF MEDICAL
FACILITIES.
The duties established in this part for a medical
facility--
(1) shall apply only to medical information
possessed by the facility during the period in which
the facility is treating the victim for conditions
arising from the emergency, or during the 60-day period
beginning on the date on which the victim is
transported by emergency response employees to the
facility, whichever period expires first; and
(2) shall not apply to any extent after the
expiration of the 30-day period beginning on the
expiration of the applicable period referred to in
paragraph (1), except that such duties shall apply with
respect to any request under section 2695B(c) received
by a medical facility before the expiration of such 30-
day period.
SEC. 2695G. [300FF-138] MISCELLANEOUS PROVISIONS.
(a) Liability of Medical Facilities, Designated Officers,
Public Health Officers, and Governing Entities.--This part may
not be construed to authorize any cause of action for damages
or any civil penalty against any medical facility, any
designated officer, any other public health officer, or any
governing entity of such facility or officer for failure to
comply with the duties established in this part.
(b) Testing.--This part may not, with respect to victims of
emergencies, be construed to authorize or require a medical
facility to test any such victim for any infectious disease.
(c) Confidentiality.--This part may not be construed to
authorize or require any medical facility, any designated
officer of emergency response employees, or any such employee,
to disclose identifying information with respect to a victim of
an emergency or with respect to an emergency response employee.
(d) Failure To Provide Emergency Services.--This part may
not be construed to authorize any emergency response employee
to fail to respond, or to deny services, to any victim of an
emergency.
(e) Notification and Reporting Deadlines.--In any case in
which the Secretary determines that, wholly or partially as a
result of a public health emergency that has been determined
pursuant to section 319(a), individuals or public or private
entities are unable to comply with the requirements of this
part, the Secretary may, notwithstanding any other provision of
law, temporarily suspend, in whole or in part, the requirements
of this part as the circumstances reasonably require. Before or
promptly after such a suspension, the Secretary shall notify
the Congress of such action and publish in the Federal Register
a notice of the suspension.
(f) Continued Application of State and Local Law.--Nothing
in this part shall be construed to limit the application of
State or local laws that require the provision of data to
public health authorities.
SEC. 2695H. [300FF-139] INJUNCTIONS REGARDING VIOLATION OF PROHIBITION.
(a) In General.--The Secretary may, in any court of
competent jurisdiction, commence a civil action for the purpose
of obtaining temporary or permanent injunctive relief with
respect to any violation of this part.
(b) Facilitation of Information on Violations.--The
Secretary shall establish an administrative process for
encouraging emergency response employees to provide information
to the Secretary regarding violations of this part. As
appropriate, the Secretary shall investigate alleged such
violations and seek appropriate injunctive relief.
SEC. 2695I. [300FF-140] APPLICABILITY OF PART.
This part shall not apply in a State if the chief executive
officer of the State certifies to the Secretary that the law of
the State is substantially consistent with this
part.4/13/2009 12:41:15 PM - f:\Vhlc\041309\041309.022
Created by: PRGriffi deg.4/13/2009 12:42:28 PM -
f:\Vhlc\041309\041309.023 Created by:
PRGriffi deg.ATTORNEY: PMG/FD (June 24, 1999) deg.
TITLE XXVII--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
Part A--Group Market Reforms \1\
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\1\ Effective on September 23, 2010, section 1001(1) of Public Law
111-148 provides for an amendment to strike the part A heading and
insert the following: ``PART A--INDIVIDUAL AND GROUP MARKET REFORMS''.
[Note: For a version of law of part A, as amended by 1001,
1201, and 1563 (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by
section 10107(b)(1)) of Public Law 111-148, see note set out in
---------------------------------------------------------------------------
italic typeface that appears after section 2723 below.]
Subpart 1--Portability, Access, and Renewability Requirements
SEC. 2701. [300GG] INCREASED PORTABILITY THROUGH LIMITATION ON
PREEXISTING CONDITION EXCLUSIONS.
(a) Limitation on Preexisting Condition Exclusion Period;
Crediting for Periods of Previous Coverage.--Subject to
subsection (d), a group health plan, and a health insurance
issuer offering group health insurance coverage, may, with
respect to a participant or beneficiary, impose a preexisting
condition exclusion only if--
(1) such exclusion relates to a condition (whether
physical or mental), regardless of the cause of the
condition, for which medical advice, diagnosis, care,
or treatment was recommended or received within the 6-
month period ending on the enrollment date;
(2) such exclusion extends for a period of not more
than 12 months (or 18 months in the case of a late
enrollee) after the enrollment date; and
(3) the period of any such preexisting condition
exclusion is reduced by the aggregate of the periods of
creditable coverage (if any, as defined in subsection
(c)(1)) applicable to the participant or beneficiary as
of the enrollment date.
(b) Definitions.--For purposes of this part--
(1) Preexisting condition exclusion.--
(A) In general.--The term ``preexisting
condition exclusion'' means, with respect to
coverage, a limitation or exclusion of benefits
relating to a condition based on the fact that
the condition was present before the date of
enrollment for such coverage, whether or not
any medical advice, diagnosis, care, or
treatment was recommended or received before
such date.
(B) Treatment of genetic information.--
Genetic information shall not be treated as a
condition described in subsection (a)(1) in the
absence of a diagnosis of the condition related
to such information.
(2) Enrollment date.--The term ``enrollment date''
means, with respect to an individual covered under a
group health plan or health insurance coverage, the
date of enrollment of the individual in the plan or
coverage or, if earlier, the first day of the waiting
period for such enrollment.
(3) Late enrollee.--The term ``late enrollee''
means, with respect to coverage under a group health
plan, a participant or beneficiary who enrolls under
the plan other than during--
(A) the first period in which the
individual is eligible to enroll under the
plan, or
(B) a special enrollment period under
subsection (f).
(4) Waiting period.--The term ``waiting period''
means, with respect to a group health plan and an
individual who is a potential participant or
beneficiary in the plan, the period that must pass with
respect to the individual before the individual is
eligible to be covered for benefits under the terms of
the plan.
(c) Rules Relating to Crediting Previous Coverage.--
(1) Creditable coverage defined.--For purposes of
this title, the term ``creditable coverage'' means,
with respect to an individual, coverage of the
individual under any of the following:
(A) A group health plan.
(B) Health insurance coverage.
(C) Part A or part B of title XVIII of the
Social Security Act.
(D) Title XIX of the Social Security Act,
other than coverage consisting solely of
benefits under section 1928.
(E) Chapter 55 of title 10, United States
Code.
(F) A medical care program of the Indian
Health Service or of a tribal organization.
(G) A State health benefits risk pool.
(H) A health plan offered under chapter 89
of
title 5, United States Code.
(I) A public health plan (as defined in
regulations).
(J) A health benefit plan under section
5(e) of the Peace Corps Act (22 U.S.C.
2504(e)).
Such term does not include coverage consisting solely
of coverage of excepted benefits (as defined in section
2791(c)).
(2) Not counting periods before significant breaks
in coverage.--
(A) In general.--A period of creditable
coverage shall not be counted, with respect to
enrollment of an individual under a group
health plan, if, after such period and before
the enrollment date, there was a 63-day period
during all of which the individual was not
covered under any creditable coverage.
(B) Waiting period not treated as a break
in coverage.--For purposes of subparagraph (A)
and subsection (d)(4), any period that an
individual is in a waiting period for any
coverage under a group health plan (or for
group health insurance coverage) or is in an
affiliation period (as defined in subsection
(g)(2)) shall not be taken into account in
determining the continuous period under
subparagraph (A).
(C) TAA-eligible individuals.--In the case
of plan years beginning before February 13,
2011--
(i) TAA pre-certification period
rule.--In the case of a TAA-eligible
individual, the period beginning on the
date the individual has a TAA-related
loss of coverage and ending on the date
that is 7 days after the date of the
issuance by the Secretary (or by any
person or entity designated by the
Secretary) of a qualified health
insurance costs credit eligibility
certificate for such individual for
purposes of section 7527 of the
Internal Revenue Code of 1986 shall not
be taken into account in determining
the continuous period under
subparagraph (A).
(ii) Definitions.--The terms ``TAA-
eligible individual'' and ``TAA-related
loss of coverage'' have the meanings
given such terms in section 2205(b)(4).
(3) Method of crediting coverage.--
(A) Standard method.--Except as otherwise
provided under subparagraph (B), for purposes
of applying subsection (a)(3), a group health
plan, and a health insurance issuer offering
group health insurance coverage, shall count a
period of creditable coverage without regard to
the specific benefits covered during the
period.
(B) Election of alternative method.--A
group health plan, or a health insurance issuer
offering group health insurance, may elect to
apply subsection (a)(3) based on coverage of
benefits within each of several classes or
categories of benefits specified in regulations
rather than as provided under subparagraph (A).
Such election shall be made on a uniform basis
for all participants and beneficiaries. Under
such election a group health plan or issuer
shall count a period of creditable coverage
with respect to any class or category of
benefits if any level of benefits is covered
within such class or category.
(C) Plan notice.--In the case of an
election with respect to a group health plan
under subparagraph (B) (whether or not health
insurance coverage is provided in connection
with such plan), the plan shall--
(i) prominently state in any
disclosure statements concerning the
plan, and state to each enrollee at the
time of enrollment under the plan, that
the plan has made such election, and
(ii) include in such statements a
description of the effect of this
election.
(D) Issuer notice.--In the case of an
election under subparagraph (B) with respect to
health insurance coverage offered by an issuer
in the small or large group market, the
issuer--
(i) shall prominently state in any
disclosure statements concerning the
coverage, and to each employer at the
time of the offer or sale of the
coverage, that the issuer has made such
election, and
(ii) shall include in such
statements a description of the effect
of such election.
(4) Establishment of period.--Periods of creditable
coverage with respect to an individual shall be
established through presentation of certifications
described in subsection (e) or in such other manner as
may be specified in regulations.
(d) Exceptions.--
(1) Exclusion not applicable to certain newborns.--
Subject to paragraph (4), a group health plan, and a
health insurance issuer offering group health insurance
coverage, may not impose any preexisting condition
exclusion in the case of an individual who, as of the
last day of the 30-day period beginning with the date
of birth, is covered under creditable coverage.
(2) Exclusion not applicable to certain adopted
children.--Subject to paragraph (4), a group health
plan, and a health insurance issuer offering group
health insurance coverage, may not impose any
preexisting condition exclusion in the case of a child
who is adopted or placed for adoption before attaining
18 years of age and who, as of the last day of the 30-
day period beginning on the date of the adoption or
placement for adoption, is covered under creditable
coverage. The previous sentence shall not apply to
coverage before the date of such adoption or placement
for adoption.
(3) Exclusion not applicable to pregnancy.--A group
health plan, and health insurance issuer offering group
health insurance coverage, may not impose any
preexisting condition exclusion relating to pregnancy
as a preexisting condition.
(4) Loss if break in coverage.--Paragraphs (1) and
(2) shall no longer apply to an individual after the
end of the first 63-day period during all of which the
individual was not covered under any creditable
coverage.
(e) Certifications and Disclosure of Coverage.--
(1) Requirement for certification of period of
creditable coverage.--
(A) In general.--A group health plan, and a
health insurance issuer offering group health
insurance coverage, shall provide the
certification described in subparagraph (B)--
(i) at the time an individual
ceases to be covered under the plan or
otherwise becomes covered under a COBRA
continuation provision,
(ii) in the case of an individual
becoming covered under such a
provision, at the time the individual
ceases to be covered under such
provision, and
(iii) on the request on behalf of
an individual made not later than 24
months after the date of cessation of
the coverage described in clause (i) or
(ii), whichever is later.
The certification under clause (i) may be
provided, to the extent practicable, at a time
consistent with notices required under any
applicable COBRA continuation provision.
(B) Certification.--The certification
described in this subparagraph is a written
certification of--
(i) the period of creditable
coverage of the individual under such
plan and the coverage (if any) under
such COBRA continuation provision, and
(ii) the waiting period (if any)
(and affiliation period, if applicable)
imposed with respect to the individual
for any coverage under such plan.
(C) Issuer compliance.--To the extent that
medical care under a group health plan consists
of group health insurance coverage, the plan is
deemed to have satisfied the certification
requirement under this paragraph if the health
insurance issuer offering the coverage provides
for such certification in accordance with this
paragraph.
(2) Disclosure of information on previous
benefits.--In the case of an election described in
subsection (c)(3)(B) by a group health plan or health
insurance issuer, if the plan or issuer enrolls an
individual for coverage under the plan and the
individual provides a certification of coverage of the
individual under paragraph (1)--
(A) upon request of such plan or issuer,
the entity which issued the certification
provided by the individual shall promptly
disclose to such requesting plan or issuer
information on coverage of classes and
categories of health benefits available under
such entity's plan or coverage, and
(B) such entity may charge the requesting
plan or issuer for the reasonable cost of
disclosing such information.
(3) Regulations.--The Secretary shall establish
rules to prevent an entity's failure to provide
information under paragraph (1) or (2) with respect to
previous coverage of an individual from adversely
affecting any subsequent coverage of the individual
under another group health plan or health insurance
coverage.
(f) Special Enrollment Periods.--
(1) Individuals losing other coverage.--A group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, shall permit an employee who is
eligible, but not enrolled, for coverage under the
terms of the plan (or a dependent of such an employee
if the dependent is eligible, but not enrolled, for
coverage under such terms) to enroll for coverage under
the terms of the plan if each of the following
conditions is met:
(A) The employee or dependent was covered
under a group health plan or had health
insurance coverage at the time coverage was
previously offered to the employee or
dependent.
(B) The employee stated in writing at such
time that coverage under a group health plan or
health insurance coverage was the reason for
declining enrollment, but only if the plan
sponsor or issuer (if applicable) required such
a statement at such time and provided the
employee with notice of such requirement (and
the consequences of such requirement) at such
time.
(C) The employee's or dependent's coverage
described in subparagraph (A)--
(i) was under a COBRA continuation
provision and the coverage under such
provision was
exhausted; or
(ii) was not under such a provision
and either the coverage was terminated
as a result of loss of eligibility for
the coverage (including as a result of
legal separation, divorce, death,
termination of employment, or reduction
in the number of hours of employment)
or employer contributions toward such
coverage were terminated.
(D) Under the terms of the plan, the
employee requests such enrollment not later
than 30 days after the date of exhaustion of
coverage described in subparagraph (C)(i) or
termination of coverage or employer
contribution described in subparagraph (C)(ii).
(2) For dependent beneficiaries.--
(A) In general.--If--
(i) a group health plan makes
coverage available with respect to a
dependent of an individual,
(ii) the individual is a
participant under the plan (or has met
any waiting period applicable to
becoming a participant under the plan
and is eligible to be enrolled under
the plan but for a failure to enroll
during a previous enrollment period),
and
(iii) a person becomes such a
dependent of the individual through
marriage, birth, or adoption or
placement for adoption,
the group health plan shall provide for a
dependent special enrollment period described
in subparagraph (B) during which the person
(or, if not otherwise enrolled, the individual)
may be enrolled under the plan as a dependent
of the individual, and in the case of the birth
or adoption of a child, the spouse of the
individual may be enrolled as a dependent of
the individual if such spouse is otherwise
eligible for coverage.
(B) Dependent special enrollment period.--A
dependent special enrollment period under this
subparagraph shall be a period of not less than
30 days and shall begin on the later of--
(i) the date dependent coverage is
made
available, or
(ii) the date of the marriage,
birth, or adoption or placement for
adoption (as the case may be) described
in subparagraph (A)(iii).
(C) No waiting period.--If an individual
seeks to enroll a dependent during the first 30
days of such a dependent special enrollment
period, the coverage of the dependent shall
become effective--
(i) in the case of marriage, not
later than the first day of the first
month beginning after the date the
completed request for enrollment is
received;
(ii) in the case of a dependent's
birth, as of the date of such birth; or
(iii) in the case of a dependent's
adoption or placement for adoption, the
date of such adoption or placement for
adoption.
(3) Special rules for application in case of
medicaid and chip.--
(A) In general.--A group health plan, and a
health insurance issuer offering group health
insurance coverage in connection with a group
health plan, shall permit an employee who is
eligible, but not enrolled, for coverage under
the terms of the plan (or a dependent of such
an employee if the dependent is eligible, but
not enrolled, for coverage under such terms) to
enroll for coverage under the terms of the plan
if either of the following conditions is met:
(i) Termination of medicaid or chip
coverage.--The employee or dependent is
covered under a Medicaid plan under
title XIX of the Social Security Act or
under a State child health plan under
title XXI of such Act and coverage of
the employee or dependent under such a
plan is terminated as a result of loss
of eligibility for such coverage and
the employee requests coverage under
the group health plan (or health
insurance coverage) not later than 60
days after the date of termination of
such coverage.
(ii) Eligibility for employment
assistance under medicaid or chip.--The
employee or dependent becomes eligible
for assistance, with respect to
coverage under the group health plan or
health insurance coverage, under such
Medicaid plan or State child health
plan (including under any waiver or
demonstration project conducted under
or in relation to such a plan), if the
employee requests coverage under the
group health plan or health insurance
coverage not later than 60 days after
the date the employee or dependent is
determined to be eligible for such
assistance.
(B) Coordination with medicaid and chip.--
(i) Outreach to employees regarding
availability of medicaid and chip
coverage.--
(I) In general.--Each
employer that maintains a group
health plan in a State that
provides medical assistance
under a State Medicaid plan
under title XIX of the Social
Security Act, or child health
assistance under a State child
health plan under title XXI of
such Act, in the form of
premium assistance for the
purchase of coverage under a
group health plan, shall
provide to each employee a
written notice informing the
employee of potential
opportunities then currently
available in the State in which
the employee resides for
premium assistance under such
plans for health coverage of
the employee or the employee's
dependents. For purposes of
compliance with this subclause,
the employer may use any State-
specific model notice developed
in accordance with section
701(f)(3)(B)(i)(II) of the
Employee Retirement Income
Security Act of 1974 (29 U.S.C.
1181(f)(3)(B)(i)(II)).
(II) Option to provide
concurrent with provision of
plan materials to employee.--An
employer may provide the model
notice applicable to the State
in which an employee resides
concurrent with the furnishing
of materials notifying the
employee of health plan
eligibility, concurrent with
materials provided to the
employee in connection with an
open season or election process
conducted under the plan, or
concurrent with the furnishing
of the summary plan description
as provided in section 104(b)
of the Employee Retirement
Income Security Act of 1974.
(ii) Disclosure about group health
plan benefits to states for medicaid
and chip eligible individuals.--In the
case of an enrollee in a group health
plan who is covered under a Medicaid
plan of a State under title XIX of the
Social Security Act or under a State
child health plan under title XXI of
such Act, the plan administrator of the
group health plan shall disclose to the
State, upon request, information about
the benefits available under the group
health plan in sufficient specificity,
as determined under regulations of the
Secretary of Health and Human Services
in consultation with the Secretary that
require use of the model coverage
coordination disclosure form developed
under section 311(b)(1)(C) of the
Children's Health Insurance
Reauthorization Act of 2009, so as to
permit the State to make a
determination (under paragraph (2)(B),
(3), or (10) of section 2105(c) of the
Social Security Act or otherwise)
concerning the cost-effectiveness of
the State providing medical or child
health assistance through premium
assistance for the purchase of coverage
under such group health plan and in
order for the State to provide
supplemental benefits required under
paragraph (10)(E) of such section or
other authority.
(g) Use of Affiliation Period by HMOs as Alternative to
Preexisting Condition Exclusion.--
(1) In general.--A health maintenance organization
which offers health insurance coverage in connection
with a group health plan and which does not impose any
preexisting condition exclusion allowed under
subsection (a) with respect to any particular coverage
option may impose an affiliation period for such
coverage option, but only if--
(A) such period is applied uniformly
without regard to any health status-related
factors; and
(B) such period does not exceed 2 months
(or 3 months in the case of a late enrollee).
(2) Affiliation period.--
(A) Defined.--For purposes of this title,
the term ``affiliation period'' means a period
which, under the terms of the health insurance
coverage offered by the health maintenance
organization, must expire before the health
insurance coverage becomes effective. The
organization is not required to provide health
care services or benefits during such period
and no premium shall be charged to the
participant or beneficiary for any coverage
during the period.
(B) Beginning.--Such period shall begin on
the enrollment date.
(C) Runs concurrently with waiting
periods.--An affiliation period under a plan
shall run concurrently with any waiting period
under the plan.
(3) Alternative methods.--A health maintenance
organization described in paragraph (1) may use
alternative methods, from those described in such
paragraph, to address adverse selection as approved by
the State insurance commissioner or official or
officials designated by the State to enforce the
requirements of this part for the State involved with
respect to such issuer.
SEC. 2702. \1\ [300GG-1] PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL
PARTICIPANTS AND BENEFICIARIES BASED ON HEALTH
STATUS.
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\1\ Effective September 23, 2010, section 1001(5) of Public Law
111-148 amends part A of title XXVII by inserting after section 2702 a
new subpart II. For version of law, see note set out in italic typeface
that appears after section 2702.
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(a) In Eligibility To Enroll.--
(1) In general.--Subject to paragraph (2), a group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, may not establish rules for
eligibility (including continued eligibility) of any
individual to enroll under the terms of the plan based
on any of the following health status-related factors
in relation to the individual or a dependent of the
individual:
(A) Health status.
(B) Medical condition (including both
physical and mental illnesses).
(C) Claims experience.
(D) Receipt of health care.
(E) Medical history.
(F) Genetic information.
(G) Evidence of insurability (including
conditions arising out of acts of domestic
violence).
(H) Disability.
(2) No application to benefits or exclusions.--To
the extent consistent with section 701, paragraph (1)
shall not be construed--
(A) to require a group health plan, or
group health insurance coverage, to provide
particular benefits other than those provided
under the terms of such plan or coverage, or
(B) to prevent such a plan or coverage from
establishing limitations or restrictions on the
amount, level, extent, or nature of the
benefits or coverage for similarly situated
individuals enrolled in the plan or coverage.
(3) Construction.--For purposes of paragraph (1),
rules for eligibility to enroll under a plan include
rules defining any applicable waiting periods for such
enrollment.
(b) In Premium Contributions.--
(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, may not require
any individual (as a condition of enrollment or
continued enrollment under the plan) to pay a premium
or contribution which is greater than such premium or
contribution for a similarly situated individual
enrolled in the plan on the basis of any health status-
related factor in relation to the individual or to an
individual enrolled under the plan as a dependent of
the individual.
(2) Construction.--Nothing in paragraph (1) shall
be construed--
(A) to restrict the amount that an employer
may be charged for coverage under a group
health plan except as provided in paragraph
(3); or
(B) to prevent a group health plan, and a
health insurance issuer offering group health
insurance coverage, from establishing premium
discounts or rebates or modifying otherwise
applicable copayments or deductibles in return
for adherence to programs of health promotion
and disease prevention.
(3) No group-based discrimination on basis of
genetic information.--
(A) In general.--For purposes of this
section, a group health plan, and health
insurance issuer offering group health
insurance coverage in connection with a group
health plan, may not adjust premium or
contribution amounts for the group covered
under such plan on the basis of genetic
information.
(B) Rule of construction.--Nothing in
subparagraph (A) or in paragraphs (1) and (2)
of subsection (d) shall be construed to limit
the ability of a health insurance issuer
offering health insurance coverage in
connection with a group health plan to increase
the premium for an employer based on the
manifestation of a disease or disorder of an
individual who is enrolled in the plan. In such
case, the manifestation of a disease or
disorder in one individual cannot also be used
as genetic information about other group
members and to further increase the premium for
the employer.
(c) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance
issuer offering health insurance coverage in connection
with a group health plan, shall not request or require
an individual or a family member of such individual to
undergo a genetic test.
(2) Rule of construction.--Paragraph (1) shall not
be construed to limit the authority of a health care
professional who is providing health care services to
an individual to request that such individual undergo a
genetic test.
(3) Rule of construction regarding payment.--
(A) In general.--Nothing in paragraph (1)
shall be construed to preclude a group health
plan, or a health insurance issuer offering
health insurance coverage in connection with a
group health plan, from obtaining and using the
results of a genetic test in making a
determination regarding payment (as such term
is defined for the purposes of applying the
regulations promulgated by the Secretary under
part C of title XI of the Social Security Act
and section 264 of the Health Insurance
Portability and Accountability Act of 1996, as
may be revised from time to time) consistent
with subsection (a).
(B) Limitation.--For purposes of
subparagraph (A), a group health plan, or a
health insurance issuer offering health
insurance coverage in connection with a group
health plan, may request only the minimum
amount of information necessary to accomplish
the intended purpose.
(4) Research exception.--Notwithstanding paragraph
(1), a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request, but not require, that a
participant or beneficiary undergo a genetic test if
each of the following conditions is met:
(A) The request is made pursuant to
research that complies with part 46 of title
45, Code of Federal Regulations, or equivalent
Federal regulations, and any applicable State
or local law or regulations for the protection
of human subjects in research.
(B) The plan or issuer clearly indicates to
each participant or beneficiary, or in the case
of a minor child, to the legal guardian of such
beneficiary, to whom the request is made that--
(i) compliance with the request is
voluntary; and
(ii) non-compliance will have no
effect on enrollment status or premium
or contribution amounts.
(C) No genetic information collected or
acquired under this paragraph shall be used for
underwriting purposes.
(D) The plan or issuer notifies the
Secretary in writing that the plan or issuer is
conducting activities pursuant to the exception
provided for under this paragraph, including a
description of the activities conducted.
(E) The plan or issuer complies with such
other conditions as the Secretary may by
regulation require for activities conducted
under this paragraph.
(d) Prohibition on Collection of Genetic Information.--
(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information for
underwriting purposes (as defined in section 2791).
(2) Prohibition on collection of genetic
information prior to enrollment.--A group health plan,
and a health insurance issuer offering health insurance
coverage in connection with a group health plan, shall
not request, require, or purchase genetic information
with respect to any individual prior to such
individual's enrollment under the plan or coverage in
connection with such enrollment.
(3) Incidental collection.--If a group health plan,
or a health insurance issuer offering health insurance
coverage in connection with a group health plan,
obtains genetic information incidental to the
requesting, requiring, or purchasing of other
information concerning any individual, such request,
requirement, or purchase shall not be considered a
violation of paragraph (2) if such request,
requirement, or purchase is not in violation of
paragraph (1).
(e) Application to All Plans.--The provisions of
subsections (a)(1)(F), (b)(3), (c) , and (d) and subsection
(b)(1) and section 2701 with respect to genetic information,
shall apply to group health plans and health insurance issuers
without regard to section 2721(a).
(f) Genetic Information of a Fetus or Embryo.--Any
reference in this part to genetic information concerning an
individual or family member of an individual shall--
(1) with respect to such an individual or family
member of an individual who is a pregnant woman,
include genetic information of any fetus carried by
such pregnant woman; and
(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include
genetic information of any embryo legally held by the
individual or family member.
======================================================================
[Note: Effective September 23, 2010, section 1001(5) of
Public Law 111-148 provides for an amendment to add after
section 2702 a new subpart II. Part A of this title is
extensively amended by inserting new sections and renumbering
existing sections throughout by such Public Law, which
amendments have different effective dates. Subpart II of part A
reads as follows:]
Subpart II--Improving Coverage
SEC. 2711. [300GG-11] NO LIFETIME OR ANNUAL LIMITS.
(a) Prohibition.--
(1) In general.--A group health plan and a health
insurance issuer offering group or individual health
insurance coverage may not establish--
(A) lifetime limits on the dollar value of
benefits for any participant or beneficiary; or
(B) except as provided in paragraph (2),
annual limits on the dollar value of benefits
for any participant or beneficiary.
(2) Annual limits prior to 2014.--With respect to
plan years beginning prior to January 1, 2014, a group
health plan and a health insurance issuer offering
group or individual health insurance coverage may only
establish a restricted annual limit on the dollar value
of benefits for any participant or beneficiary with
respect to the scope of benefits that are essential
health benefits under section 1302(b) of the Patient
Protection and Affordable Care Act, as determined by
the Secretary. In defining the term ``restricted annual
limit'' for purposes of the preceding sentence, the
Secretary shall ensure that access to needed services
is made available with a minimal impact on premiums.
(b) Per Beneficiary Limits.--Subsection (a) shall not be
construed to prevent a group health plan or health insurance
coverage from placing annual or lifetime per beneficiary limits
on specific covered benefits that are not essential health
benefits under section 1302(b) of the Patient Protection and
Affordable Care Act, to the extent that such limits are
otherwise permitted under Federal or State law.
SEC. 2712. [300GG-12] PROHIBITION ON RESCISSIONS.
A group health plan and a health insurance issuer offering
group or individual health insurance coverage shall not rescind
such plan or coverage with respect to an enrollee once the
enrollee is covered under such plan or coverage involved,
except that this section shall not apply to a covered
individual who has performed an act or practice that
constitutes fraud or makes an intentional misrepresentation of
material fact as prohibited by the terms of the plan or
coverage. Such plan or coverage may not be cancelled except
with prior notice to the enrollee, and only as permitted under
section 2702(c) or 2742(b).
SEC. 2713. [300GG-13] COVERAGE OF PREVENTIVE HEALTH SERVICES.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
shall, at a minimum provide coverage for and shall not impose
any cost sharing requirements for--
(1) evidence-based items or services that have in
effect a rating of ``A'' or ``B'' in the current
recommendations of the United States Preventive
Services Task Force;
(2) immunizations that have in effect a
recommendation from the Advisory Committee on
Immunization Practices of the Centers for Disease
Control and Prevention with respect to the individual
involved; and
(3) with respect to infants, children, and
adolescents, evidence-informed preventive care and
screenings provided for in the comprehensive guidelines
supported by the Health Resources and Services
Administration.
(4) with respect to women, such additional
preventive care and screenings not described in
paragraph (1) as provided for in comprehensive
guidelines supported by the Health Resources and
Services Administration for purposes of this paragraph.
(5) for the purposes of this Act, and for the
purposes of any other provision of law, the current
recommendations of the United States Preventive Service
Task Force regarding breast cancer screening,
mammography, and prevention shall be considered the
most current other than those issued in or around
November 2009.
Nothing in this subsection shall be construed to prohibit a
plan or issuer from providing coverage for services in addition
to those recommended by United States Preventive Services Task
Force or to deny coverage for services that are not recommended
by such Task Force.
(b) Interval.--
(1) In general.--The Secretary shall establish a
minimum interval between the date on which a
recommendation described in subsection (a)(1) or (a)(2)
or a guideline under subsection (a)(3) is issued and
the plan year with respect to which the requirement
described in subsection (a) is effective with respect
to the service described in such recommendation or
guideline.
(2) Minimum.--The interval described in paragraph
(1) shall not be less than 1 year.
(c) Value-based Insurance Design.--The Secretary may
develop guidelines to permit a group health plan and a health
insurance issuer offering group or individual health insurance
coverage to utilize value-based insurance designs.
SEC. 2714. [300GG-14] EXTENSION OF DEPENDENT COVERAGE.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
that provides dependent coverage of children shall continue to
make such coverage available for an adult child until the child
turns 26 years of age. Nothing in this section shall require a
health plan or a health insurance issuer described in the
preceding sentence to make coverage available for a child of a
child receiving dependent coverage.
(b) Regulations.--The Secretary shall promulgate
regulations to define the dependents to which coverage shall be
made available under subsection (a).
(c) Rule of Construction.--Nothing in this section shall be
construed to modify the definition of ``dependent'' as used in
the Internal Revenue Code of 1986 with respect to the tax
treatment of the cost of coverage.
SEC. 2715. [300GG-15] DEVELOPMENT AND UTILIZATION OF UNIFORM
EXPLANATION OF COVERAGE DOCUMENTS AND STANDARDIZED
DEFINITIONS.
(a) In General.--Not later than 12 months after the date of
enactment of the Patient Protection and Affordable Care Act,
the Secretary shall develop standards for use by a group health
plan and a health insurance issuer offering group or individual
health insurance coverage, in compiling and providing to
applicants, enrollees, and policyholders or certificate holders
a summary of benefits and coverage explanation that accurately
describes the benefits and coverage under the applicable plan
or coverage. In developing such standards, the Secretary shall
consult with the National Association of Insurance
Commissioners (referred to in this section as the ``NAIC''), a
working group composed of representatives of health insurance-
related consumer advocacy organizations, health insurance
issuers, health care professionals, patient advocates including
those representing individuals with limited English
proficiency, and other qualified individuals.
(b) Requirements.--The standards for the summary of
benefits and coverage developed under subsection (a) shall
provide for the following:
(1) Appearance.--The standards shall ensure that
the summary of benefits and coverage is presented in a
uniform format that does not exceed 4 pages in length
and does not include print smaller than 12-point font.
(2) Language.--The standards shall ensure that the
summary is presented in a culturally and linguistically
appropriate manner and utilizes terminology
understandable by the average plan enrollee.
(3) Contents.--The standards shall ensure that the
summary of benefits and coverage includes--
(A) uniform definitions of standard
insurance terms and medical terms (consistent
with subsection (g)) so that consumers may
compare health insurance coverage and
understand the terms of coverage (or exception
to such coverage);
(B) a description of the coverage,
including cost sharing for--
(i) each of the categories of the
essential health benefits described in
subparagraphs (A) through (J) of
section 1302(b)(1) of the Patient
Protection and Affordable Care Act; and
(ii) other benefits, as identified
by the Secretary;
(C) the exceptions, reductions, and
limitations on coverage;
(D) the cost-sharing provisions, including
deductible, coinsurance, and co-payment
obligations;
(E) the renewability and continuation of
coverage provisions;
(F) a coverage facts label that includes
examples to illustrate common benefits
scenarios, including pregnancy and serious or
chronic medical conditions and related cost
sharing, such scenarios to be based on
recognized clinical practice guidelines;
(G) a statement of whether the plan or
coverage--
(i) provides minimum essential
coverage (as defined under section
5000A(f) of the Internal Revenue Code
1986); and
(ii) ensures that the plan or
coverage share of the total allowed
costs of benefits provided under the
plan or coverage is not less than 60
percent of such costs;
(H) a statement that the outline is a
summary of the policy or certificate and that
the coverage document itself should be
consulted to determine the governing
contractual provisions; and
(I) a contact number for the consumer to
call with additional questions and an Internet
web address where a copy of the actual
individual coverage policy or group certificate
of coverage can be reviewed and obtained.
(c) Periodic Review and Updating.--The Secretary shall
periodically review and update, as appropriate, the standards
developed under this section.
(d) Requirement To Provide.--
(1) In general.--Not later than 24 months after the
date of enactment of the Patient Protection and
Affordable Care Act, each entity described in paragraph
(3) shall provide, prior to any enrollment restriction,
a summary of benefits and coverage explanation pursuant
to the standards developed by the Secretary under
subsection (a) to--
(A) an applicant at the time of
application;
(B) an enrollee prior to the time of
enrollment or reenrollment, as applicable; and
(C) a policyholder or certificate holder at
the time of issuance of the policy or delivery
of the certificate.
(2) Compliance.--An entity described in paragraph
(3) is deemed to be in compliance with this section if
the summary of benefits and coverage described in
subsection (a) is provided in paper or electronic form.
(3) Entities in general.--An entity described in
this paragraph is--
(A) a health insurance issuer (including a
group health plan that is not a self-insured
plan) offering health insurance coverage within
the United States; or
(B) in the case of a self-insured group
health plan, the plan sponsor or designated
administrator of the plan (as such terms are
defined in section 3(16) of the Employee
Retirement Income Security Act of 1974).
(4) Notice of modifications.--If a group health
plan or health insurance issuer makes any material
modification in any of the terms of the plan or
coverage involved (as defined for purposes of section
102 of the Employee Retirement Income Security Act of
1974) that is not reflected in the most recently
provided summary of benefits and coverage, the plan or
issuer shall provide notice of such modification to
enrollees not later than 60 days prior to the date on
which such modification will become effective.
(e) Preemption.--The standards developed under subsection
(a) shall preempt any related State standards that require a
summary of benefits and coverage that provides less information
to consumers than that required to be provided under this
section, as determined by the Secretary.
(f) Failure To Provide.--An entity described in subsection
(d)(3) that willfully fails to provide the information required
under this section shall be subject to a fine of not more than
$1,000 for each such failure. Such failure with respect to each
enrollee shall constitute a separate offense for purposes of
this subsection.
(g) Development of Standard Definitions.--
(1) In general.--The Secretary shall, by
regulation, provide for the development of standards
for the definitions of terms used in health insurance
coverage, including the insurance-related terms
described in paragraph (2) and the medical terms
described in paragraph (3).
(2) Insurance-related terms.--The insurance-related
terms described in this paragraph are premium,
deductible, co-insurance, co-payment, out-of-pocket
limit, preferred provider, non-preferred provider, out-
of-network co-payments, UCR (usual, customary and
reasonable) fees, excluded services, grievance and
appeals, and such other terms as the Secretary
determines are important to define so that consumers
may compare health insurance coverage and understand
the terms of their coverage.
(3) Medical terms.--The medical terms described in
this paragraph are hospitalization, hospital outpatient
care, emergency room care, physician services,
prescription drug coverage, durable medical equipment,
home health care, skilled nursing care, rehabilitation
services, hospice services, emergency medical
transportation, and such other terms as the Secretary
determines are important to define so that consumers
may compare the medical benefits offered by health
insurance and understand the extent of those medical
benefits (or exceptions to those benefits).
SEC. 2715A. [300GG-15A] PROVISION OF ADDITIONAL INFORMATION.
A group health plan and a health insurance issuer offering
group or individual health insurance coverage shall comply with
the provisions of section 1311(e)(3) of the Patient Protection
and Affordable Care Act, except that a plan or coverage that is
not offered through an Exchange shall only be required to
submit the information required to the Secretary and the State
insurance commissioner, and make such information available to
the public.
SEC. 2716. [300GG-16] PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY
COMPENSATED INDIVIDUALS.
(a) In General.--A group health plan (other than a self-
insured plan) shall satisfy the requirements of section
105(h)(2) of the Internal Revenue Code of 1986 (relating to
prohibition on discrimination in favor of highly compensated
individuals).
(b) Rules and Definitions.--For purposes of this section--
(1) Certain rules to apply.--Rules similar to the
rules contained in paragraphs (3), (4), and (8) of
section 105(h) of such Code shall apply.
(2) Highly compensated individual.--The term
``highly compensated individual'' has the meaning given
such term by section 105(h)(5) of such Code.
SEC. 2717. [300GG-17] ENSURING THE QUALITY OF CARE.
(a) Quality Reporting.--
(1) In general.--Not later than 2 years after the
date of enactment of the Patient Protection and
Affordable Care Act, the Secretary, in consultation
with experts in health care quality and stakeholders,
shall develop reporting requirements for use by a group
health plan, and a health insurance issuer offering
group or individual health insurance coverage, with
respect to plan or coverage benefits and health care
provider reimbursement structures that--
(A) improve health outcomes through the
implementation of activities such as quality
reporting, effective case management, care
coordination, chronic disease management, and
medication and care compliance initiatives,
including through the use of the medical homes
model as defined for purposes of section 3602
of the Patient Protection and Affordable Care
Act, for treatment or services under the plan
or coverage;
(B) implement activities to prevent
hospital readmissions through a comprehensive
program for hospital discharge that includes
patient-centered education and counseling,
comprehensive discharge planning, and post
discharge reinforcement by an appropriate
health care professional;
(C) implement activities to improve patient
safety and reduce medical errors through the
appropriate use of best clinical practices,
evidence based medicine, and health information
technology under the plan or coverage; and
(D) implement wellness and health promotion
activities.
(2) Reporting requirements.--
(A) In general.--A group health plan and a
health insurance issuer offering group or
individual health insurance coverage shall
annually submit to the Secretary, and to
enrollees under the plan or coverage, a report
on whether the benefits under the plan or
coverage satisfy the elements described in
subparagraphs (A) through (D) of paragraph (1).
(B) Timing of reports.--A report under
subparagraph (A) shall be made available to an
enrollee under the plan or coverage during each
open enrollment period.
(C) Availability of reports.--The Secretary
shall make reports submitted under subparagraph
(A) available to the public through an Internet
website.
(D) Penalties.--In developing the reporting
requirements under paragraph (1), the Secretary
may develop and impose appropriate penalties
for non-compliance with such requirements.
(E) Exceptions.--In developing the
reporting requirements under paragraph (1), the
Secretary may provide for exceptions to such
requirements for group health plans and health
insurance issuers that substantially meet the
goals of this section.
(b) Wellness and Prevention Programs.--For purposes of
subsection (a)(1)(D), wellness and health promotion activities
may include personalized wellness and prevention services,
which are coordinated, maintained or delivered by a health care
provider, a wellness and prevention plan manager, or a health,
wellness or prevention services organization that conducts
health risk assessments or offers ongoing face-to-face,
telephonic or web-based intervention efforts for each of the
program's participants, and which may include the following
wellness and prevention efforts:
(1) Smoking cessation.
(2) Weight management.
(3) Stress management.
(4) Physical fitness.
(5) Nutrition.
(6) Heart disease prevention.
(7) Healthy lifestyle support.
(8) Diabetes prevention.
(c) Protection of Second Amendment Gun Rights.--
(1) Wellness and prevention programs.--A wellness
and health promotion activity implemented under
subsection (a)(1)(D) may not require the disclosure or
collection of any information relating to--
(A) the presence or storage of a lawfully-
possessed firearm or ammunition in the
residence or on the property of an individual;
or
(B) the lawful use, possession, or storage
of a firearm or ammunition by an individual.
(2) Limitation on data collection.--None of the
authorities provided to the Secretary under the Patient
Protection and Affordable Care Act or an amendment made
by that Act shall be construed to authorize or may be
used for the collection of any information relating
to--
(A) the lawful ownership or possession of a
firearm or ammunition;
(B) the lawful use of a firearm or
ammunition; or
(C) the lawful storage of a firearm or
ammunition.
(3) Limitation on databases or data banks.--None of
the authorities provided to the Secretary under the
Patient Protection and Affordable Care Act or an
amendment made by that Act shall be construed to
authorize or may be used to maintain records of
individual ownership or possession of a firearm or
ammunition.
(4) Limitation on determination of premium rates or
eligibility for health insurance.--A premium rate may
not be increased, health insurance coverage may not be
denied, and a discount, rebate, or reward offered for
participation in a wellness program may not be reduced
or withheld under any health benefit plan issued
pursuant to or in accordance with the Patient
Protection and Affordable Care Act or an amendment made
by that Act on the basis of, or on reliance upon--
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use or storage of a firearm
or ammunition.
(5) Limitation on data collection requirements for
individuals.--No individual shall be required to
disclose any information under any data collection
activity authorized under the Patient Protection and
Affordable Care Act or an amendment made by that Act
relating to--
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use, possession, or storage
of a firearm or ammunition.
(d) Regulations.--Not later than 2 years after the date of
enactment of the Patient Protection and Affordable Care Act,
the Secretary shall promulgate regulations that provide
criteria for determining whether a reimbursement structure is
described in subsection (a).
(e) Study and Report.--Not later than 180 days after the
date on which regulations are promulgated under subsection (c),
the Government Accountability Office shall review such
regulations and conduct a study and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report regarding the impact the activities
under this section have had on the quality and cost of health
care.
SEC. 2718. [300GG-18] BRINGING DOWN THE COST OF HEALTH CARE COVERAGE.
(a) Clear Accounting for Costs.--A health insurance issuer
offering group or individual health insurance coverage
(including a grandfathered health plan) shall, with respect to
each plan year, submit to the Secretary a report concerning the
ratio of the incurred loss (or incurred claims) plus the loss
adjustment expense (or change in contract reserves) to earned
premiums. Such report shall include the percentage of total
premium revenue, after accounting for collections or receipts
for risk adjustment and risk corridors and payments of
reinsurance, that such coverage expends--
(1) on reimbursement for clinical services provided
to enrollees under such coverage;
(2) for activities that improve health care
quality; and
(3) on all other non-claims costs, including an
explanation of the nature of such costs, and excluding
Federal and State taxes and licensing or regulatory
fees.
The Secretary shall make reports received under this section
available to the public on the Internet website of the
Department of Health and Human Services.
(b) Ensuring That Consumers Receive Value for Their Premium
Payments.--
(1) Requirement to provide value for premium
payments.--
(A) Requirement.--Beginning not later than
January 1, 2011, a health insurance issuer
offering group or individual health insurance
coverage (including a grandfathered health
plan) shall, with respect to each plan year,
provide an annual rebate to each enrollee under
such coverage, on a pro rata basis, if the
ratio of the amount of premium revenue expended
by the issuer on costs described in paragraphs
(1) and (2) of subsection (a) to the total
amount of premium revenue (excluding Federal
and State taxes and licensing or regulatory
fees and after accounting for payments or
receipts for risk adjustment, risk corridors,
and reinsurance under sections 1341, 1342, and
1343 of the Patient Protection and Affordable
Care Act) for the plan year (except as provided
in subparagraph (B)(ii)), is less than--
(i) with respect to a health
insurance issuer offering coverage in
the large group market, 85 percent, or
such higher percentage as a State may
by regulation determine; or
(ii) with respect to a health
insurance issuer offering coverage in
the small group market or in the
individual market, 80 percent, or such
higher percentage as a State may by
regulation determine, except that the
Secretary may adjust such percentage
with respect to a State if the
Secretary determines that the
application of such 80 percent may
destabilize the individual market in
such State.
(B) Rebate amount.--
(i) Calculation of amount.--The
total amount of an annual rebate
required under this paragraph shall be
in an amount equal to the product of--
(I) the amount by which the
percentage described in clause
(i) or (ii) of subparagraph (A)
exceeds the ratio described in
such subparagraph; and
(II) the total amount of
premium revenue (excluding
Federal and State taxes and
licensing or regulatory fees
and after accounting for
payments or receipts for risk
adjustment, risk corridors, and
reinsurance under sections
1341, 1342, and 1343 of the
Patient Protection and
Affordable Care Act) for such
plan year.
(ii) Calculation based on average
ratio.--Beginning on January 1, 2014,
the determination made under
subparagraph (A) for the year involved
shall be based on the averages of the
premiums expended on the costs
described in such subparagraph and
total premium revenue for each of the
previous 3 years for the plan.
(2) Consideration in setting percentages.--In
determining the percentages under paragraph (1), a
State shall seek to ensure adequate participation by
health insurance issuers, competition in the health
insurance market in the State, and value for consumers
so that premiums are used for clinical services and
quality improvements.
(3) Enforcement.--The Secretary shall promulgate
regulations for enforcing the provisions of this
section and may provide for appropriate penalties.
(c) Definitions.--Not later than December 31, 2010, and
subject to the certification of the Secretary, the National
Association of Insurance Commissioners shall establish uniform
definitions of the activities reported under subsection (a) and
standardized methodologies for calculating measures of such
activities, including definitions of which activities, and in
what regard such activities, constitute activities described in
subsection (a)(2). Such methodologies shall be designed to take
into account the special circumstances of smaller plans,
different types of plans, and newer plans.
(d) Adjustments.--The Secretary may adjust the rates
described in subsection (b) if the Secretary determines
appropriate on account of the volatility of the individual
market due to the establishment of State Exchanges.
(e) Standard Hospital Charges.--Each hospital operating
within the United States shall for each year establish (and
update) and make public (in accordance with guidelines
developed by the Secretary) a list of the hospital's standard
charges for items and services provided by the hospital,
including for diagnosis-related groups established under
section 1886(d)(4) of the Social Security Act.
SEC. 2719. [300GG-19] APPEALS PROCESS.
(a) Internal Claims Appeals.--
(1) In general.--A group health plan and a health
insurance issuer offering group or individual health
insurance coverage shall implement an effective appeals
process for appeals of coverage determinations and
claims, under which the plan or issuer shall, at a
minimum--
(A) have in effect an internal claims
appeal process;
(B) provide notice to enrollees, in a
culturally and linguistically appropriate
manner, of available internal and external
appeals processes, and the availability of any
applicable office of health insurance consumer
assistance or ombudsman established under
section 2793 to assist such enrollees with the
appeals processes; and
(C) allow an enrollee to review their file,
to present evidence and testimony as part of
the appeals process, and to receive continued
coverage pending the outcome of the appeals
process.
(2) Established processes.--To comply with
paragraph (1)--
(A) a group health plan and a health
insurance issuer offering group health coverage
shall provide an internal claims and appeals
process that initially incorporates the claims
and appeals procedures (including urgent
claims) set forth at section 2560.503-1 of
title 29, Code of Federal Regulations, as
published on November 21, 2000 (65 Fed. Reg.
70256), and shall update such process in
accordance with any standards established by
the Secretary of Labor for such plans and
issuers; and
(B) a health insurance issuer offering
individual health coverage, and any other
issuer not subject to subparagraph (A), shall
provide an internal claims and appeals process
that initially incorporates the claims and
appeals procedures set forth under applicable
law (as in existence on the date of enactment
of this section), and shall update such process
in accordance with any standards established by
the Secretary of Health and Human Services for
such issuers.
(b) External Review.--A group health plan and a health
insurance issuer offering group or individual health insurance
coverage--
(1) shall comply with the applicable State external
review process for such plans and issuers that, at a
minimum, includes the consumer protections set forth in
the Uniform External Review Model Act promulgated by
the National Association of Insurance Commissioners and
is binding on such plans; or
(2) shall implement an effective external review
process that meets minimum standards established by the
Secretary through guidance and that is similar to the
process described under paragraph (1)--
(A) if the applicable State has not
established an external review process that
meets the requirements of paragraph (1); or
(B) if the plan is a self-insured plan that
is not subject to State insurance regulation
(including a State law that establishes an
external review process described in paragraph
(1)).
(c) Secretary Authority.--The Secretary may deem the
external review process of a group health plan or health
insurance issuer, in operation as of the date of enactment of
this section, to be in compliance with the applicable process
established under subsection (b), as determined appropriate by
the Secretary.
SEC. 2719A. [300GG-19A] PATIENT PROTECTIONS.
(a) Choice of Health Care Professional.--If a group health
plan, or a health insurance issuer offering group or individual
health insurance coverage, requires or provides for designation
by a participant, beneficiary, or enrollee of a participating
primary care provider, then the plan or issuer shall permit
each participant, beneficiary, and enrollee to designate any
participating primary care provider who is available to accept
such individual.
(b) Coverage of Emergency Services.--
(1) In general.--If a group health plan, or a
health insurance issuer offering group or individual
health insurance issuer, provides or covers any
benefits with respect to services in an emergency
department of a hospital, the plan or issuer shall
cover emergency services (as defined in paragraph
(2)(B))--
(A) without the need for any prior
authorization determination;
(B) whether the health care provider
furnishing such services is a participating
provider with respect to such services;
(C) in a manner so that, if such services
are provided to a participant, beneficiary, or
enrollee--
(i) by a nonparticipating health
care provider with or without prior
authorization; or
(ii)(I) such services will be
provided without imposing any
requirement under the plan for prior
authorization of services or any
limitation on coverage where the
provider of services does not have a
contractual relationship with the plan
for the providing of services that is
more restrictive than the requirements
or limitations that apply to emergency
department services received from
providers who do have such a
contractual relationship with the plan;
and
(II) if such services are provided
out-of-network, the cost-sharing
requirement (expressed as a copayment
amount or coinsurance rate) is the same
requirement that would apply if such
services were provided in-network;
(D) without regard to any other term or
condition of such coverage (other than
exclusion or coordination of benefits, or an
affiliation or waiting period, permitted under
section 2701 of this Act, section 701 of the
Employee Retirement Income Security Act of
1974, or section 9801 of the Internal Revenue
Code of 1986, and other than applicable cost-
sharing).
(2) Definitions.--In this subsection:
(A) Emergency medical condition.--The term
``emergency medical condition'' means a medical
condition manifesting itself by acute symptoms
of sufficient severity (including severe pain)
such that a prudent layperson, who possesses an
average knowledge of health and medicine, could
reasonably expect the absence of immediate
medical attention to result in a condition
described in clause (i), (ii), or (iii) of
section 1867(e)(1)(A) of the Social Security
Act.
(B) Emergency services.--The term
``emergency services'' means, with respect to
an emergency medical condition--
(i) a medical screening examination
(as required under section 1867 of the
Social Security Act) that is within the
capability of the emergency department
of a hospital, including ancillary
services routinely available to the
emergency department to evaluate such
emergency medical condition, and
(ii) within the capabilities of the
staff and facilities available at the
hospital, such further medical
examination and treatment as are
required under section 1867 of such Act
to stabilize the patient.
(C) Stabilize.--The term ``to stabilize'',
with respect to an emergency medical condition
(as defined in subparagraph (A)), has the
meaning give in section 1867(e)(3) of the
Social Security Act (42 U.S.C. 1395dd(e)(3)).
(c) Access to Pediatric Care.--
(1) Pediatric care.--In the case of a person who
has a child who is a participant, beneficiary, or
enrollee under a group health plan, or health insurance
coverage offered by a health insurance issuer in the
group or individual market, if the plan or issuer
requires or provides for the designation of a
participating primary care provider for the child, the
plan or issuer shall permit such person to designate a
physician (allopathic or osteopathic) who specializes
in pediatrics as the child's primary care provider if
such provider participates in the network of the plan
or issuer.
(2) Construction.--Nothing in paragraph (1) shall
be construed to waive any exclusions of coverage under
the terms and conditions of the plan or health
insurance coverage with respect to coverage of
pediatric care.
(d) Patient Access to Obstetrical and Gynecological Care.--
(1) General rights.--
(A) Direct access.--A group health plan, or
health insurance issuer offering group or
individual health insurance coverage, described
in paragraph (2) may not require authorization
or referral by the plan, issuer, or any person
(including a primary care provider described in
paragraph (2)(B)) in the case of a female
participant, beneficiary, or enrollee who seeks
coverage for obstetrical or gynecological care
provided by a participating health care
professional who specializes in obstetrics or
gynecology. Such professional shall agree to
otherwise adhere to such plan's or issuer's
policies and procedures, including procedures
regarding referrals and obtaining prior
authorization and providing services pursuant
to a treatment plan (if any) approved by the
plan or issuer.
(B) Obstetrical and gynecological care.--A
group health plan or health insurance issuer
described in paragraph (2) shall treat the
provision of obstetrical and gynecological
care, and the ordering of related obstetrical
and gynecological items and services, pursuant
to the direct access described under
subparagraph (A), by a participating health
care professional who specializes in obstetrics
or gynecology as the authorization of the
primary care provider.
(2) Application of paragraph.--A group health plan,
or health insurance issuer offering group or individual
health insurance coverage, described in this paragraph
is a group health plan or coverage that--
(A) provides coverage for obstetric or
gynecologic care; and
(B) requires the designation by a
participant, beneficiary, or enrollee of a
participating primary care provider.
(3) Construction.--Nothing in paragraph (1) shall
be construed to--
(A) waive any exclusions of coverage under
the terms and conditions of the plan or health
insurance coverage with respect to coverage of
obstetrical or gynecological care; or
(B) preclude the group health plan or
health insurance issuer involved from requiring
that the obstetrical or gynecological provider
notify the primary care health care
professional or the plan or issuer of treatment
decisions.
=======================================================================
Subpart 2--Other Requirements \1\
---------------------------------------------------------------------------
\1\ Effective January 1, 2014, the probable intent of Congress is
to strike both the subpart designation and heading, but the amendment
by section 1563 (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by section
10107(b)(1)) of Public Law 111-148, strikes only the ``second
heading''.
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SEC. 2704. [300GG-4] STANDARDS RELATING TO BENEFITS FOR MOTHERS AND
NEWBORNS. \2\
---------------------------------------------------------------------------
\2\ Effective September 23, 2010, section 1001(2) of Public Law
111-148 provides for an amendment to redesignate sections 2704 through
2707 as sections 2725 through 2728.
---------------------------------------------------------------------------
(a) Requirements for Minimum Hospital Stay Following
Birth.--
(1) In general.--A group health plan, and a health
insurance issuer offering group health insurance
coverage, may not--
(A) except as provided in paragraph (2)--
(i) restrict benefits for any
hospital length of stay in connection
with childbirth for the mother or
newborn child, following a normal
vaginal delivery, to less than 48
hours, or
(ii) restrict benefits for any
hospital length of stay in connection
with childbirth for the mother or
newborn child, following a cesarean
section, to less than 96 hours, or
(B) require that a provider obtain
authorization from the plan or the issuer for
prescribing any length of stay required under
subparagraph (A) (without regard to paragraph
(2)).
(2) Exception.--Paragraph (1)(A) shall not apply in
connection with any group health plan or health
insurance issuer in any case in which the decision to
discharge the mother or her newborn child prior to the
expiration of the minimum length of stay otherwise
required under paragraph (1)(A) is made by an attending
provider in consultation with the mother.
(b) Prohibitions.--A group health plan, and a health
insurance issuer offering group health insurance coverage in
connection with a group health plan, may not--
(1) deny to the mother or her newborn child
eligibility, or continued eligibility, to enroll or to
renew coverage under the terms of the plan, solely for
the purpose of avoiding the requirements of this
section;
(2) provide monetary payments or rebates to mothers
to encourage such mothers to accept less than the
minimum protections available under this section;
(3) penalize or otherwise reduce or limit the
reimbursement of an attending provider because such
provider provided care to an individual participant or
beneficiary in accordance with this section;
(4) provide incentives (monetary or otherwise) to
an attending provider to induce such provider to
provide care to an individual participant or
beneficiary in a manner inconsistent with this section;
or
(5) subject to subsection (c)(3), restrict benefits
for any portion of a period within a hospital length of
stay required under subsection (a) in a manner which is
less favorable than the benefits provided for any
preceding portion of such stay.
(c) Rules of Construction.--
(1) Nothing in this section shall be construed to
require a mother who is a participant or beneficiary--
(A) to give birth in a hospital; or
(B) to stay in the hospital for a fixed
period of time following the birth of her
child.
(2) This section shall not apply with respect to
any group health plan, or any group health insurance
coverage offered by a health insurance issuer, which
does not provide benefits for hospital lengths of stay
in connection with childbirth for a mother or her
newborn child.
(3) Nothing in this section shall be construed as
preventing a group health plan or issuer from imposing
deductibles, coinsurance, or other cost-sharing in
relation to benefits for hospital lengths of stay in
connection with childbirth for a mother or newborn
child under the plan (or under health insurance
coverage offered in connection with a group health
plan), except that such coinsurance or other cost-
sharing for any portion of a period within a hospital
length of stay required under subsection (a) may not be
greater than such coinsurance or cost-sharing for any
preceding portion of such stay.
(d) Notice.--A group health plan under this part shall
comply with the notice requirement under section 711(d) of the
Employee Retirement Income Security Act of 1974 with respect to
the requirements of this section as if such section applied to
such plan.
(e) Level and Type of Reimbursements.--Nothing in this
section shall be construed to prevent a group health plan or a
health insurance issuer offering group health insurance
coverage from negotiating the level and type of reimbursement
with a provider for care provided in accordance with this
section.
(f) Preemption; Exception for Health Insurance Coverage in
Certain States.--
(1) In general.--The requirements of this section
shall not apply with respect to health insurance
coverage if there is a State law (as defined in section
2723(d)(1)) for a State that regulates such coverage
that is described in any of the following
subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital
length of stay following a normal vaginal
delivery and at least a 96-hour hospital length
of stay following a cesarean section.
(B) Such State law requires such coverage
to provide for maternity and pediatric care in
accordance with guidelines established by the
American College of Obstetricians and
Gynecologists, the American Academy of
Pediatrics, or other established professional
medical associations.
(C) Such State law requires, in connection
with such coverage for maternity care, that the
hospital length of stay for such care is left
to the decision of (or required to be made by)
the attending provider in consultation with the
mother.
(2) Construction.--Section 2723(a)(1) shall not be
construed as superseding a State law described in
paragraph (1).
SEC. 2705. [300GG-5] PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER
BENEFITS. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 2704.
---------------------------------------------------------------------------
(a) In General.--
(1) Aggregate lifetime limits.--In the case of a
group health plan (or health insurance coverage offered
in connection with such a plan) that provides both
medical and surgical benefits and mental health or
substance use disorder benefits--
(A) No lifetime limit.--If the plan or
coverage does not include an aggregate lifetime
limit on substantially all medical and surgical
benefits, the plan or coverage may not impose
any aggregate lifetime limit on mental health
or substance use disorder benefits.
(B) Lifetime limit.--If the plan or
coverage includes an aggregate lifetime limit
on substantially all medical and surgical
benefits (in this paragraph referred to as the
``applicable lifetime limit''), the plan or
coverage shall either--
(i) apply the applicable lifetime
limit both to the medical and surgical
benefits to which it otherwise would
apply and to mental health and
substance use disorder benefits and not
distinguish in the application of such
limit between such medical and surgical
benefits and mental health and
substance use disorder benefits; or
(ii) not include any aggregate
lifetime limit on mental health or
substance use disorder benefits that is
less than the applicable lifetime
limit.
(C) Rule in case of different limits.--In
the case of a plan or coverage that is not
described in subparagraph (A) or (B) and that
includes no or different aggregate lifetime
limits on different categories of medical and
surgical benefits, the Secretary shall
establish rules under which subparagraph (B) is
applied to such plan or coverage with respect
to mental health and substance use disorder
benefits by substituting for the applicable
lifetime limit an average aggregate lifetime
limit that is computed taking into account the
weighted average of the aggregate lifetime
limits applicable to such categories.
(2) Annual limits.--In the case of a group health
plan (or health insurance coverage offered in
connection with such a plan) that provides both medical
and surgical benefits and mental health or substance
use disorder benefits--
(A) No annual limit.--If the plan or
coverage does not include an annual limit on
substantially all medical and surgical
benefits, the plan or coverage may not impose
any annual limit on mental health or substance
use disorder benefits.
(B) Annual limit.--If the plan or coverage
includes an annual limit on substantially all
medical and surgical benefits (in this
paragraph referred to as the ``applicable
annual limit''), the plan or coverage shall
either--
(i) apply the applicable annual
limit both to medical and surgical
benefits to which it otherwise would
apply and to mental health and
substance use disorder benefits and not
distinguish in the application of such
limit between such medical and surgical
benefits and mental health and
substance use disorder benefits; or
(ii) not include any annual limit
on mental health or substance use
disorder benefits that is less than the
applicable annual limit.
(C) Rule in case of different limits.--In
the case of a plan or coverage that is not
described in subparagraph (A) or (B) and that
includes no or different annual limits on
different categories of medical and surgical
benefits, the Secretary shall establish rules
under which subparagraph (B) is applied to such
plan or coverage with respect to mental health
and substance use disorder benefits by
substituting for the applicable annual limit an
average annual limit that is computed taking
into account the weighted average of the annual
limits applicable to such categories.
(3) Financial requirements and treatment
limitations.--
(A) In general.--In the case of a group
health plan (or health insurance coverage
offered in connection with such a plan) that
provides both medical and surgical benefits and
mental health or substance use disorder
benefits, such plan or coverage shall ensure
that--
(i) the financial requirements
applicable to such mental health or
substance use disorder benefits are no
more restrictive than the predominant
financial requirements applied to
substantially all medical and surgical
benefits covered by the plan (or
coverage), and there are no separate
cost sharing requirements that are
applicable only with respect to mental
health or substance use disorder
benefits; and
(ii) the treatment limitations
applicable to such mental health or
substance use disorder benefits are no
more restrictive than the predominant
treatment limitations applied to
substantially all medical and surgical
benefits covered by the plan (or
coverage) and there are no separate
treatment limitations that are
applicable only with respect to mental
health or substance use disorder
benefits.
(B) Definitions.--In this paragraph:
(i) Financial requirement.--The
term ``financial requirement'' includes
deductibles, copayments, coinsurance,
and out-of-pocket expenses, but
excludes an aggregate lifetime limit
and an annual limit subject to
paragraphs (1) and (2).
(ii) Predominant.--A financial
requirement or treatment limit is
considered to be predominant if it is
the most common or frequent of such
type of limit or requirement.
(iii) Treatment limitation.--The
term ``treatment limitation'' includes
limits on the frequency of treatment,
number of visits, days of coverage, or
other similar limits on the scope or
duration of treatment.
(4) Availability of plan information.--The criteria
for medical necessity determinations made under the
plan with respect to mental health or substance use
disorder benefits (or the health insurance coverage
offered in connection with the plan with respect to
such benefits) shall be made available by the plan
administrator (or the health insurance issuer offering
such coverage) in accordance with regulations to any
current or potential participant, beneficiary, or
contracting provider upon request. The reason for any
denial under the plan (or coverage) of reimbursement or
payment for services with respect to mental health or
substance use disorder benefits in the case of any
participant or beneficiary shall, on request or as
otherwise required, be made available by the plan
administrator (or the health insurance issuer offering
such coverage) to the participant or beneficiary in
accordance with regulations.
(5) Out-of-network providers.--In the case of a
plan or coverage that provides both medical and
surgical benefits and mental health or substance use
disorder benefits, if the plan or coverage provides
coverage for medical or surgical benefits provided by
out-of-network providers, the plan or coverage shall
provide coverage for mental health or substance use
disorder benefits provided by out-of-network providers
in a manner that is consistent with the requirements of
this section.
(b) Construction.--Nothing in this section shall be
construed--
(1) as requiring a group health plan (or health
insurance coverage offered in connection with such a
plan) to provide any mental health or substance use
disorder benefits; or
(2) in the case of a group health plan (or health
insurance coverage offered in connection with such a
plan) that provides mental health or substance use
disorder benefits, as affecting the terms and
conditions of the plan or coverage relating to such
benefits under the plan or coverage, except as provided
in subsection (a).
(c) Exemptions.--
(1) Small employer exemption.--This section shall
not apply to any group health plan (and group health
insurance coverage offered in connection with a group
health plan) for any plan year of a small employer (as
defined in section 2791(e)(4), except that for purposes
of this paragraph such term shall include employers
with 1 employee in the case of an employer residing in
a State that permits small groups to include a single
individual).
(2) Cost exemption.--
(A) In general.--With respect to a group
health plan (or health insurance coverage
offered in connection with such a plan), if the
application of this section to such plan (or
coverage) results in an increase for the plan
year involved of the actual total costs of
coverage with respect to medical and surgical
benefits and mental health and substance use
disorder benefits under the plan (as determined
and certified under subparagraph (C)) by an
amount that exceeds the applicable percentage
described in subparagraph (B) of the actual
total plan costs, the provisions of this
section shall not apply to such plan (or
coverage) during the following plan year, and
such exemption shall apply to the plan (or
coverage) for 1 plan year. An employer may
elect to continue to apply mental health and
substance use disorder parity pursuant to this
section with respect to the group health plan
(or coverage) involved regardless of any
increase in total costs.
(B) Applicable percentage.--With respect to
a plan (or coverage), the applicable percentage
described in this subparagraph shall be--
(i) 2 percent in the case of the
first plan year in which this section
is applied; and
(ii) 1 percent in the case of each
subsequent plan year.
(C) Determinations by actuaries.--
Determinations as to increases in actual costs
under a plan (or coverage) for purposes of this
section shall be made and certified by a
qualified and licensed actuary who is a member
in good standing of the American Academy of
Actuaries. All such determinations shall be in
a written report prepared by the actuary. The
report, and all underlying documentation relied
upon by the actuary, shall be maintained by the
group health plan or health insurance issuer
for a period of 6 years following the
notification made under subparagraph (E).
(D) 6-month determinations.--If a group
health plan (or a health insurance issuer
offering coverage in connection with a group
health plan) seeks an exemption under this
paragraph, determinations under subparagraph
(A) shall be made after such plan (or coverage)
has complied with this section for the first 6
months of the plan year involved.
(E) Notification.--
(i) In general.--A group health
plan (or a health insurance issuer
offering coverage in connection with a
group health plan) that, based upon a
certification described under
subparagraph (C), qualifies for an
exemption under this paragraph, and
elects to implement the exemption,
shall promptly notify the Secretary,
the appropriate State agencies, and
participants and beneficiaries in the
plan of such election.
(ii) Requirement.--A notification
to the Secretary under clause (i) shall
include--
(I) a description of the
number of covered lives under
the plan (or coverage) involved
at the time of the
notification, and as
applicable, at the time of any
prior election of the cost-
exemption under this paragraph
by such plan (or coverage);
(II) for both the plan year
upon which a cost exemption is
sought and the year prior, a
description of the actual total
costs of coverage with respect
to medical and surgical
benefits and mental health and
substance use disorder benefits
under the plan; and
(III) for both the plan
year upon which a cost
exemption is sought and the
year prior, the actual total
costs of coverage with respect
to mental health and substance
use disorder benefits under the
plan.
(iii) Confidentiality.--A
notification to the Secretary under
clause (i) shall be confidential. The
Secretary shall make available, upon
request and on not more than an annual
basis, an anonymous itemization of such
notifications, that includes--
(I) a breakdown of States
by the size and type of
employers submitting such
notification; and
(II) a summary of the data
received under clause (ii).
(F) Audits by appropriate agencies.--To
determine compliance with this paragraph, the
Secretary may audit the books and records of a
group health plan or health insurance issuer
relating to an exemption, including any
actuarial reports prepared pursuant to
subparagraph (C), during the 6 year period
following the notification of such exemption
under subparagraph (E). A State agency
receiving a notification under subparagraph (E)
may also conduct such an audit with respect to
an exemption covered by such notification.
(d) Separate Application to Each Option Offered.--In the
case of a group health plan that offers a participant or
beneficiary two or more benefit package options under the plan,
the requirements of this section shall be applied separately
with respect to each such option.
(e) Definitions.--For purposes of this section--
(1) Aggregate lifetime limit.--The term ``aggregate
lifetime limit'' means, with respect to benefits under
a group health plan or health insurance coverage, a
dollar limitation on the total amount that may be paid
with respect to such benefits under the plan or health
insurance coverage with respect to an individual or
other coverage unit.
(2) Annual limit.--The term ``annual limit'' means,
with respect to benefits under a group health plan or
health
insurance coverage, a dollar limitation on the total
amount of benefits that may be paid with respect to
such benefits in a 12-month period under the plan or
health insurance coverage with respect to an individual
or other coverage unit.
(3) Medical or surgical benefits.--The term
``medical or surgical benefits'' means benefits with
respect to
medical or surgical services, as defined under the
terms of the plan or coverage (as the case may be), but
does not include mental health or substance use
disorder benefits.
(4) Mental health benefits.--The term ``mental
health benefits'' means benefits with respect to
services for mental health conditions, as defined under
the terms of the plan and in accordance with applicable
Federal and State law.
(5) Substance use disorder benefits.--The term
``substance use disorder benefits'' means benefits with
respect to services for substance use disorders, as
defined under the terms of the plan and in accordance
with applicable Federal and State law.
SEC. 2706. [300GG-6] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY
FOLLOWING MASTECTOMIES. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 2704.
---------------------------------------------------------------------------
The provisions of section 713 of the Employee Retirement
Income Security Act of 1974 shall apply to group health plans,
and health insurance issuers providing health insurance
coverage in connection with group health plans, as if included
in this subpart. \2\
---------------------------------------------------------------------------
\2\ Section 2706 was added by subsection (a) of section 903 of the
Departments of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1999 (as contained in section
101(f) of division A of Public Law 105-277; 112 Stat. 2681-438).
Subsection (c) of such section 903 concerns effective dates, and
paragraph (1) of the subsection provides as follows:
---------------------------------------------------------------------------
``(1) Group plans.--
``(A) In general.--The amendment made by subsection
(a) shall apply to group health plans for plan years
beginning on or after the date of enactment of this
Act.
``(B) Special rule for collective bargaining
agreements.--In the case of a group health plan
maintained pursuant to 1 or more collective bargaining
agreements between employee representatives and 1 or
more employers, any plan amendment made pursuant to a
collective bargaining agreement relating to the plan
which amends the plan solely to conform to any
requirement added by the amendment made by subsection
(a) shall not be treated as a termination of such
collective bargaining agreement.''.
---------------------------------------------------------------------------
The Public Law was enacted October 21, 1998.
---------------------------------------------------------------------------
SEC. 2707. [300GG-7] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY
NECESSARY LEAVE OF ABSENCE. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 2704.
---------------------------------------------------------------------------
(a) Medically Necessary Leave of Absence.--In this section,
the term ``medically necessary leave of absence'' means, with
respect to a dependent child described in subsection (b)(2) in
connection with a group health plan or health insurance
coverage offered in connection with such plan, a leave of
absence of such child from a postsecondary educational
institution (including an institution of higher education as
defined in section 102 of the Higher Education Act of 1965), or
any other change in enrollment of such child at such an
institution, that--
(1) commences while such child is suffering from a
serious illness or injury;
(2) is medically necessary; and
(3) causes such child to lose student status for
purposes of coverage under the terms of the plan or
coverage.
(b) Requirement To Continue Coverage.--
(1) In general.--In the case of a dependent child
described in paragraph (2), a group health plan, or a
health insurance issuer that provides health insurance
coverage in connection with a group health plan, shall
not terminate coverage of such child under such plan or
health insurance coverage due to a medically necessary
leave of absence before the date that is the earlier
of--
(A) the date that is 1 year after the first
day of the medically necessary leave of
absence; or
(B) the date on which such coverage would
otherwise terminate under the terms of the plan
or health insurance coverage.
(2) Dependent child described.--A dependent child
described in this paragraph is, with respect to a group
health plan or health insurance coverage offered in
connection with the plan, a beneficiary under the plan
who--
(A) is a dependent child, under the terms
of the plan or coverage, of a participant or
beneficiary under the plan or coverage; and
(B) was enrolled in the plan or coverage,
on the basis of being a student at a
postsecondary educational institution (as
described in subsection (a)), immediately
before the first day of the medically necessary
leave of absence involved.
(3) Certification by physician.--Paragraph (1)
shall apply to a group health plan or health insurance
coverage offered by an issuer in connection with such
plan only if the plan or issuer of the coverage has
received written certification by a treating physician
of the dependent child which states that the child is
suffering from a serious illness or injury and that the
leave of absence (or other change of enrollment)
described in subsection (a) is medically necessary.
(c) Notice.--A group health plan, and a health insurance
issuer providing health insurance coverage in connection with a
group health plan, shall include, with any notice regarding a
requirement for certification of student status for coverage
under the plan or coverage, a description of the terms of this
section for continued coverage during medically necessary
leaves of absence. Such description shall be in language which
is understandable to the typical plan participant.
(d) No Change in Benefits.--A dependent child whose
benefits are continued under this section shall be entitled to
the same benefits as if (during the medically necessary leave
of absence) the child continued to be a covered student at the
institution of higher education and was not on a medically
necessary leave of absence.
(e) Continued Application in Case of Changed Coverage.--
If--
(1) a dependent child of a participant or
beneficiary is in a period of coverage under a group
health plan or health insurance coverage offered in
connection with such a plan, pursuant to a medically
necessary leave of absence of the child described in
subsection (b);
(2) the manner in which the participant or
beneficiary is covered under the plan changes, whether
through a change in health insurance coverage or health
insurance issuer, a change between health insurance
coverage and self-insured coverage, or otherwise; and
(3) the coverage as so changed continues to provide
coverage of beneficiaries as dependent children,
this section shall apply to coverage of the child under the
changed coverage for the remainder of the period of the
medically necessary leave of absence of the dependent child
under the plan in the same manner as it would have applied if
the changed coverage had been the previous coverage.
Subpart 3--Provisions Applicable Only to Health Insurance Issuers
SEC. 2711. [300GG-11] GUARANTEED AVAILABILITY OF COVERAGE FOR EMPLOYERS
IN THE GROUP MARKET. \1\
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\1\ Effective September 23, 2010, section 1001(3) of Public Law
111-148 provides an amendment to redesignate sections 2711 through 2713
as sections 2731 through 2733.
---------------------------------------------------------------------------
(a) Issuance of Coverage in the Small Group Market.--
(1) In general.--Subject to subsections (c) through
(f), each health insurance issuer that offers health
insurance coverage in the small group market in a
State--
(A) must accept every small employer (as
defined in section 2791(e)(4)) in the State
that applies for such coverage; and
(B) must accept for enrollment under such
coverage every eligible individual (as defined
in paragraph (2)) who applies for enrollment
during the period in which the individual first
becomes eligible to enroll under the terms of
the group health plan and may not place any
restriction which is inconsistent with section
2702 on an eligible individual being a
participant or beneficiary.
(2) Eligible individual defined.--For purposes of
this section, the term ``eligible individual'' means,
with respect to a health insurance issuer that offers
health insurance coverage to a small employer in
connection with a group health plan in the small group
market, such an individual in relation to the employer
as shall be determined--
(A) in accordance with the terms of such
plan,
(B) as provided by the issuer under rules
of the issuer which are uniformly applicable in
a State to small employers in the small group
market, and
(C) in accordance with all applicable State
laws governing such issuer and such market.
(b) Assuring Access in the Large Group Market.--
(1) Reports to hhs.--The Secretary shall request
that the chief executive officer of each State submit
to the Secretary, by not later December 31, 2000, and
every 3 years thereafter a report on--
(A) the access of large employers to health
insurance coverage in the State, and
(B) the circumstances for lack of access
(if any) of large employers (or one or more
classes of such employers) in the State to such
coverage.
(2) Triennial reports to congress.--The Secretary,
based on the reports submitted under paragraph (1) and
such other information as the Secretary may use, shall
prepare and submit to Congress, every 3 years, a report
describing the extent to which large employers (and
classes of such employers) that seek health insurance
coverage in the different States are able to obtain
access to such coverage. Such report shall include such
recommendations as the Secretary determines to be
appropriate.
(3) GAO report on large employer access to health
insurance coverage.--The Comptroller General shall
provide for a study of the extent to which classes of
large employers in the different States are able to
obtain access to health insurance coverage and the
circumstances for lack of access (if any) to such
coverage. The Comptroller General shall submit to
Congress a report on such study not later than 18
months after the date of the enactment of this title.
(c) Special Rules for Network Plans.--
(1) In general.--In the case of a health insurance
issuer that offers health insurance coverage in the
small group market through a network plan, the issuer
may--
(A) limit the employers that may apply for
such coverage to those with eligible
individuals who live, work, or reside in the
service area for such network plan; and
(B) within the service area of such plan,
deny such coverage to such employers if the
issuer has demonstrated, if required, to the
applicable State authority that--
(i) it will not have the capacity
to deliver services adequately to
enrollees of any additional groups
because of its obligations to existing
group contract holders and enrollees,
and
(ii) it is applying this paragraph
uniformly to all employers without
regard to the claims experience of
those employers and their employees
(and their dependents) or any health
status-related factor relating to such
employees and dependents.
(2) 180-day suspension upon denial of coverage.--An
issuer, upon denying health insurance coverage in any
service area in accordance with paragraph (1)(B), may
not offer coverage in the small group market within
such service area for a period of 180 days after the
date such coverage is denied.
(d) Application of Financial Capacity Limits.--
(1) In general.--A health insurance issuer may deny
health insurance coverage in the small group market if
the issuer has demonstrated, if required, to the
applicable State authority that--
(A) it does not have the financial reserves
necessary to underwrite additional coverage;
and
(B) it is applying this paragraph uniformly
to all employers in the small group market in
the State consistent with applicable State law
and without regard to the claims experience of
those employers and their employees (and their
dependents) or any health status-related factor
relating to such employees and dependents.
(2) 180-day suspension upon denial of coverage.--A
health insurance issuer upon denying health insurance
coverage in connection with group health plans in
accordance with paragraph (1) in a State may not offer
coverage in connection with group health plans in the
small group market in the State for a period of 180
days after the date such coverage is denied or until
the issuer has demonstrated to the applicable State
authority, if required under applicable State law, that
the issuer has sufficient financial reserves to
underwrite additional coverage, whichever is later. An
applicable State authority may provide for the
application of this subsection on a service-area-
specific basis.
(e) Exception to Requirement for Failure To Meet Certain
Minimum Participation or Contribution Rules.--
(1) In general.--Subsection (a) shall not be
construed to preclude a health insurance issuer from
establishing employer contribution rules or group
participation rules for the offering of health
insurance coverage in connection with a group health
plan in the small group market, as allowed under
applicable State law.
(2) Rules defined.--For purposes of paragraph (1)--
(A) the term ``employer contribution rule''
means a requirement relating to the minimum
level or amount of employer contribution toward
the premium for enrollment of participants and
beneficiaries; and
(B) the term ``group participation rule''
means a requirement relating to the minimum
number of participants or beneficiaries that
must be enrolled in relation to a specified
percentage or number of eligible individuals or
employees of an employer.
(f) Exception for Coverage Offered Only to Bona Fide
Association Members.--Subsection (a) shall not apply to health
insurance coverage offered by a health insurance issuer if such
coverage is made available in the small group market only
through one or more bona fide associations (as defined in
section 2791(d)(3)).
SEC. 2712. [300GG-12] GUARANTEED RENEWABILITY OF COVERAGE FOR EMPLOYERS
IN THE GROUP MARKET. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 2711.
---------------------------------------------------------------------------
(a) In General.--Except as provided in this section, if a
health insurance issuer offers health insurance coverage in the
small or large group market in connection with a group health
plan, the issuer must renew or continue in force such coverage
at the option of the plan sponsor of the plan.
(b) General Exceptions.--A health insurance issuer may
nonrenew or discontinue health insurance coverage offered in
connection with a group health plan in the small or large group
market based only on one or more of the following:
(1) Nonpayment of premiums.--The plan sponsor has
failed to pay premiums or contributions in accordance
with the terms of the health insurance coverage or the
issuer has not received timely premium payments.
(2) Fraud.--The plan sponsor has performed an act
or practice that constitutes fraud or made an
intentional misrepresentation of material fact under
the terms of the coverage.
(3) Violation of participation or contribution
rules.--The plan sponsor has failed to comply with a
material plan provision relating to employer
contribution or group participation rules, as permitted
under section 2711(e) in the case of the small group
market or pursuant to applicable State law in the case
of the large group market.
(4) Termination of coverage.--The issuer is ceasing
to offer coverage in such market in accordance with
subsection (c) and applicable State law.
(5) Movement outside service area.--In the case of
a health insurance issuer that offers health insurance
coverage in the market through a network plan, there is
no longer any enrollee in connection with such plan who
lives, resides, or works in the service area of the
issuer (or in the area for which the issuer is
authorized to do business) and, in the case of the
small group market, the issuer would deny enrollment
with respect to such plan under section 2711(c)(1)(A).
(6) Association membership ceases.--In the case of
health insurance coverage that is made available in the
small or large group market (as the case may be) only
through one or more bona fide associations, the
membership of an employer in the association (on the
basis of which the coverage is provided) ceases but
only if such coverage is terminated under this
paragraph uniformly without regard to any health
status-related factor relating to any covered
individual.
(c) Requirements for Uniform Termination of Coverage.--
(1) Particular type of coverage not offered.--In
any case in which an issuer decides to discontinue
offering a particular type of group health insurance
coverage offered in the small or large group market,
coverage of such type may be discontinued by the issuer
in accordance with applicable State law in such market
only if--
(A) the issuer provides notice to each plan
sponsor provided coverage of this type in such
market (and participants and beneficiaries
covered under such coverage) of such
discontinuation at least 90 days prior to the
date of the discontinuation of such coverage;
(B) the issuer offers to each plan sponsor
provided coverage of this type in such market,
the option to purchase all (or, in the case of
the large group market, any) other health
insurance coverage currently being offered by
the issuer to a group health plan in such
market; and
(C) in exercising the option to discontinue
coverage of this type and in offering the
option of coverage under subparagraph (B), the
issuer acts uniformly without regard to the
claims experience of those sponsors or any
health status-related factor relating to any
participants or beneficiaries covered or new
participants or beneficiaries who may become
eligible for such coverage.
(2) Discontinuance of all coverage.--
(A) In general.--In any case in which a
health insurance issuer elects to discontinue
offering all health insurance coverage in the
small group market or the large group market,
or both markets, in a State, health insurance
coverage may be discontinued by the issuer only
in accordance with applicable State law and
if--
(i) the issuer provides notice to
the applicable State authority and to
each plan sponsor (and participants and
beneficiaries covered under such
coverage) of such discontinuation at
least 180 days prior to the date of the
discontinuation of such coverage; and
(ii) all health insurance issued or
delivered for issuance in the State in
such market (or markets) are
discontinued and coverage under such
health insurance coverage in such
market (or markets) is not renewed.
(B) Prohibition on market reentry.--In the
case of a discontinuation under subparagraph
(A) in a market, the issuer may not provide for
the issuance of any health insurance coverage
in the market and State involved during the 5-
year period beginning on the date of the
discontinuation of the last health insurance
coverage not so renewed.
(d) Exception for Uniform Modification of Coverage.--At the
time of coverage renewal, a health insurance issuer may modify
the health insurance coverage for a product offered to a group
health plan--
(1) in the large group market; or
(2) in the small group market if, for coverage that
is available in such market other than only through one
or more bona fide associations, such modification is
consistent with State law and effective on a uniform
basis among group health plans with that product.
(e) Application to Coverage Offered Only Through
Associations.--In applying this section in the case of health
insurance coverage that is made available by a health insurance
issuer in the small or large group market to employers only
through one or more associations, a reference to ``plan
sponsor'' is deemed, with respect to coverage provided to an
employer member of the association, to include a reference to
such employer.
SEC. 2713. [300GG-13] DISCLOSURE OF INFORMATION. \1\
---------------------------------------------------------------------------
\1\ See footnote for section 2711.
---------------------------------------------------------------------------
(a) Disclosure of Information by Health Plan Issuers.--In
connection with the offering of any health insurance coverage
to a small employer, a health insurance issuer--
(1) shall make a reasonable disclosure to such
employer, as part of its solicitation and sales
materials, of the availability of information described
in subsection (b), and
(2) upon request of such a small employer, provide
such information.
(b) Information Described.--
(1) In general.--Subject to paragraph (3), with
respect to a health insurance issuer offering health
insurance coverage to a small employer, information
described in this subsection is information
concerning--
(A) the provisions of such coverage
concerning issuer's right to change premium
rates and the factors that may affect changes
in premium rates;
(B) the provisions of such coverage
relating to renewability of coverage;
(C) the provisions of such coverage
relating to any preexisting condition
exclusion; and
(D) the benefits and premiums available
under all health insurance coverage for which
the employer is qualified.
(2) Form of information.--Information under this
subsection shall be provided to small employers in a
manner determined to be understandable by the average
small employer, and shall be sufficient to reasonably
inform small employers of their rights and obligations
under the health insurance coverage.
(3) Exception.--An issuer is not required under
this section to disclose any information that is
proprietary and trade secret information under
applicable law.
Subpart 4--Exclusion of Plans; Enforcement; Preemption
SEC. 2721. \2\ [300GG-21] EXCLUSION OF CERTAIN PLANS. \1\
---------------------------------------------------------------------------
\1\ Section 604(b) of Public Law 104-204 (110 Stat. 2940) provided
that various provisions of section 2721 are amended by striking
``subparts 1 and 2'' and inserting ``subparts 1 and 3''. Subsection (c)
of such section provides as follows:
(c) Effective Date.--The amendments made by this section shall
apply with respect to group health plans for plan years beginning on or
after January 1, 1998.
\2\ Effective September 23, 2010, section 1001(4) of Public Law
111-148 provides an amendment to redesignate sections 2721 through 2723
as sections 2735 through 2737.
---------------------------------------------------------------------------
(a) Exception for Certain Small Group Health Plans.--The
requirements of subparts 1 and 3 \1\ shall not apply to any
group health plan (and health insurance coverage offered in
connection with a group health plan) for any plan year if, on
the first day of such plan year, such plan has less than 2
participants who are current employees.
(b) Limitation on Application of Provisions Relating to
Group Health Plans.--
(1) In general.--The requirements of subparts 1
through 3 shall apply with respect to group health
plans only--
(A) subject to paragraph (2), in the case
of a plan that is a nonfederal governmental
plan, and
(B) with respect to health insurance
coverage offered in connection with a group
health plan (including such a plan that is a
church plan or a governmental plan).
(2) Treatment of nonfederal governmental plans.--
(A) Election to be excluded.--Except as
provided in subparagraph (D), if the plan
sponsor of a nonfederal governmental plan which
is a group health plan to which the provisions
of subparts 1 through 3 otherwise apply makes
an election under this subparagraph (in such
form and manner as the Secretary may by
regulations prescribe), then the requirements
of such subparts insofar as they apply directly
to group health plans (and not merely to group
health insurance coverage) shall not apply to
such governmental plans for such period except
as provided in this paragraph.
(B) Period of election.--An election under
subparagraph (A) shall apply--
(i) for a single specified plan
year, or
(ii) in the case of a plan provided
pursuant to a collective bargaining
agreement, for the term of such
agreement.
An election under clause (i) may be extended
through subsequent elections under this
paragraph.
(C) Notice to enrollees.--Under such an
election, the plan shall provide for--
(i) notice to enrollees (on an
annual basis and at the time of
enrollment under the plan) of the fact
and consequences of such election, and
(ii) certification and disclosure
of creditable coverage under the plan
with respect to enrollees in accordance
with section 2701(e).
(D) Election not applicable to requirements
concerning genetic information.--The election
described in subparagraph (A) shall not be
available with respect to the provisions of
subsections (a)(1)(F), (b)(3), (c), and (d) of
section 2702 and the provisions of sections
2701 and 2702(b) to the extent that such
provisions apply to genetic information.
(c) Exception for Certain Benefits.--The requirements of
subparts 1 through 3 shall not apply to any group health plan
(or group health insurance coverage) in relation to its
provision of excepted benefits described in section 2791(c)(1).
(d) Exception for Certain Benefits If Certain Conditions
Met.--
(1) Limited, excepted benefits.--The requirements
of subparts 1 through 3 shall not apply to any group
health plan (and group health insurance coverage
offered in connection with a group health plan) in
relation to its provision of excepted benefits
described in section 2791(c)(2) if the benefits--
(A) are provided under a separate policy,
certificate, or contract of insurance; or
(B) are otherwise not an integral part of
the plan.
(2) Noncoordinated, excepted benefits.--The
requirements of subparts 1 through 3 shall not apply to
any group health plan (and group health insurance
coverage offered in connection with a group health
plan) in relation to its provision of excepted benefits
described in section 2791(c)(3) if all of the following
conditions are met:
(A) The benefits are provided under a
separate policy, certificate, or contract of
insurance.
(B) There is no coordination between the
provision of such benefits and any exclusion of
benefits under any group health plan maintained
by the same plan sponsor.
(C) Such benefits are paid with respect to
an event without regard to whether benefits are
provided with respect to such an event under
any group health plan maintained by the same
plan sponsor.
(3) Supplemental excepted benefits.--The
requirements of this part shall not apply to any group
health plan (and group health insurance coverage) in
relation to its provision of excepted benefits
described in section 27971(c)(4) if the benefits are
provided under a separate policy, certificate, or
contract of insurance.
(e) Treatment of Partnerships.--For purposes of this part--
(1) Treatment as a group health plan.--Any plan,
fund, or program which would not be (but for this
subsection) an employee welfare benefit plan and which
is established or maintained by a partnership, to the
extent that such plan, fund, or program provides
medical care (including items and services paid for as
medical care) to present or former partners in the
partnership or to their dependents (as defined under
the terms of the plan, fund, or program), directly or
through insurance, reimbursement, or otherwise, shall
be treated (subject to paragraph (2)) as an employee
welfare benefit plan which is a group health plan.
(2) Employer.--In the case of a group health plan,
the term ``employer'' also includes the partnership in
relation to any partner.
(3) Participants of group health plans.--In the
case of a group health plan, the term ``participant''
also includes--
(A) in connection with a group health plan
maintained by a partnership, an individual who
is a partner in relation to the partnership, or
(B) in connection with a group health plan
maintained by a self-employed individual (under
which one or more employees are participants),
the self-employed individual,
if such individual is, or may become, eligible to
receive a benefit under the plan or such individual's
beneficiaries may be eligible to receive any such
benefit.
SEC. 2722. [300GG-22] ENFORCEMENT.
(a) State Enforcement.--
(1) State authority.--Subject to section 2723, each
State may require that health insurance issuers that
issue, sell, renew, or offer health insurance coverage
in the State in the small or large group markets meet
the requirements of this part with respect to such
issuers.
(2) Failure to implement provisions.--In the case
of a determination by the Secretary that a State has
failed to substantially enforce a provision (or
provisions) in this part with respect to health
insurance issuers in the State, the Secretary shall
enforce such provision (or provisions) under subsection
(b) insofar as they relate to the issuance, sale,
renewal, and offering of health insurance coverage in
connection with group health plans in such State.
(b) Secretarial Enforcement Authority.--
(1) Limitation.--The provisions of this subsection
shall apply to enforcement of a provision (or
provisions) of this part only--
(A) as provided under subsection (a)(2);
and
(B) with respect to group health plans that
are non-Federal governmental plans.
(2) Imposition of penalties.--In the cases
described in paragraph (1)--
(A) In general.--Subject to the succeeding
provisions of this subsection, any non-Federal
governmental plan that is a group health plan
and any health insurance issuer that fails to
meet a provision of this part applicable to
such plan or issuer is subject to a civil money
penalty under this subsection.
(B) Liability for penalty.--In the case of
a
failure by--
(i) a health insurance issuer, the
issuer is liable for such penalty, or
(ii) a group health plan that is a
non-Federal governmental plan which
is--
(I) sponsored by 2 or more
employers, the plan is liable
for such penalty, or
(II) not so sponsored, the
employer is liable for such
penalty.
(C) Amount of penalty.--
(i) In general.--The maximum amount
of penalty imposed under this paragraph
is $100 for each day for each
individual with respect to which such a
failure occurs.
(ii) Considerations in
imposition.--In determining the amount
of any penalty to be assessed under
this paragraph, the Secretary shall
take into account the previous record
of compliance of the entity being
assessed with the applicable provisions
of this part and the gravity of the
violation.
(iii) Limitations.--
(I) Penalty not to apply
where failure not discovered
exercising reasonable
diligence.--No civil money
penalty shall be imposed under
this paragraph on any failure
during any period for which it
is established to the
satisfaction of the Secretary
that none of the entities
against whom the penalty would
be imposed knew, or exercising
reasonable diligence would have
known, that such failure
existed.
(II) Penalty not to apply
to failures corrected within 30
days.--No civil money penalty
shall be imposed under this
paragraph on any failure if
such failure was due to
reasonable cause and not to
willful neglect, and such
failure is corrected during the
30-day period beginning on the
first day any of the entities
against whom the penalty would
be imposed knew, or exercising
reasonable diligence would have
known, that such failure
existed.
(D) Administrative review.--
(i) Opportunity for hearing.--The
entity assessed shall be afforded an
opportunity for hearing by the
Secretary upon request made within 30
days after the date of the issuance of
a notice of assessment. In such hearing
the decision shall be made on the
record pursuant to section 554 of title
5, United States Code. If no hearing is
requested, the assessment shall
constitute a final and unappealable
order.
(ii) Hearing procedure.--If a
hearing is requested, the initial
agency decision shall be made by an
administrative law judge, and such
decision shall become the final order
unless the Secretary modifies or
vacates the decision. Notice of intent
to modify or vacate the decision of the
administrative law judge shall be
issued to the parties within 30 days
after the date of the decision of the
judge. A final order which takes effect
under this paragraph shall be
subject to review only as provided
under subparagraph (E).
(E) Judicial review.--
(i) Filing of action for review.--
Any entity against whom an order
imposing a civil money penalty has been
entered after an agency hearing under
this paragraph may obtain review by the
United States district court for any
district in which such entity is
located or the United States District
Court for the District of Columbia by
filing a notice of appeal in such court
within 30 days from the date of such
order, and simultaneously sending a
copy of such notice by registered mail
to the Secretary.
(ii) Certification of
administrative record.--The Secretary
shall promptly certify and file in such
court the record upon which the penalty
was imposed.
(iii) Standard for review.--The
findings of the Secretary shall be set
aside only if found to be unsupported
by substantial evidence as provided by
section 706(2)(E) of title 5, United
States Code.
(iv) Appeal.--Any final decision,
order, or judgment of the district
court concerning such review shall be
subject to appeal as provided in
chapter 83 of title 28 of such Code.
(F) Failure to pay assessment; maintenance
of action.--
(i) Failure to pay assessment.--If
any entity fails to pay an assessment
after it has become a final and
unappealable order, or after the court
has entered final judgment in favor of
the Secretary, the Secretary shall
refer the matter to the Attorney
General who shall recover the amount
assessed by action in the appropriate
United States district court.
(ii) Nonreviewability.--In such
action the validity and appropriateness
of the final order imposing the penalty
shall not be subject to review.
(G) Payment of penalties.--Except as
otherwise provided, penalties collected under
this paragraph shall be paid to the Secretary
(or other officer) imposing the penalty and
shall be available without appropriation and
until expended for the purpose of enforcing the
provisions with respect to which the penalty
was imposed.
(3) Enforcement authority relating to genetic
discrimination.--
(A) General rule.--In the cases described
in paragraph (1), notwithstanding the
provisions of paragraph (2)(C), the succeeding
subparagraphs of this paragraph shall apply
with respect to an action under this subsection
by the Secretary with respect to any failure of
a health insurance issuer in connection with a
group health plan, to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of
section 2702 or section 2701 or 2702(b)(1) with
respect to genetic information in connection
with the plan.
(B) Amount.--
(i) In general.--The amount of the
penalty imposed under this paragraph
shall be $100 for each day in the
noncompliance period with respect to
each participant or beneficiary to whom
such failure relates.
(ii) Noncompliance period.--For
purposes of this paragraph, the term
``noncompliance period'' means, with
respect to any failure, the period--
(I) beginning on the date
such failure first occurs; and
(II) ending on the date the
failure is corrected.
(C) Minimum penalties where failure
discovered.--Notwithstanding clauses (i) and
(ii) of subparagraph (D):
(i) In general.--In the case of 1
or more failures with respect to an
individual--
(I) which are not corrected
before the date on which the
plan receives a notice from the
Secretary of such violation;
and
(II) which occurred or
continued during the period
involved;
the amount of penalty imposed by
subparagraph (A) by reason of such
failures with respect to such
individual shall not be less than
$2,500.
(ii) Higher minimum penalty where
violations are more than de minimis.--
To the extent violations for which any
person is liable under this paragraph
for any year are more than de minimis,
clause (i) shall be applied by
substituting ``$15,000'' for ``$2,500''
with respect to such person.
(D) Limitations.--
(i) Penalty not to apply where
failure not discovered exercising
reasonable diligence.--No penalty shall
be imposed by subparagraph (A) on any
failure during any period for which it
is established to the satisfaction of
the Secretary that the person otherwise
liable for such penalty did not know,
and exercising reasonable diligence
would not have known, that such failure
existed.
(ii) Penalty not to apply to
failures corrected within certain
periods.--No penalty shall be imposed
by subparagraph (A) on any failure if--
(I) such failure was due to
reasonable cause and not to
willful neglect; and
(II) such failure is
corrected during the 30-day
period beginning on the first
date the person otherwise
liable for such penalty knew,
or exercising reasonable
diligence would have known,
that such failure existed.
(iii) Overall limitation for
unintentional failures.--In the case of
failures which are due to reasonable
cause and not to willful neglect, the
penalty imposed by subparagraph (A) for
failures shall not exceed the amount
equal to the lesser of--
(I) 10 percent of the
aggregate amount paid or
incurred by the employer (or
predecessor employer) during
the preceding taxable year for
group health plans; or
(II) $500,000.
(E) Waiver by secretary.--In the case of a
failure which is due to reasonable cause and
not to willful neglect, the Secretary may waive
part or all of the penalty imposed by
subparagraph (A) to the extent that the payment
of such penalty would be excessive relative to
the failure involved.
SEC. 2723. [300GG-23] PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.
(a) Continued Applicability of State Law With Respect to
Health Insurance Issuers.--
(1) In General.--Subject to paragraph (2) and
except as provided in subsection (b), this part and
part C insofar as it relates to this part shall not be
construed to supersede any provision of State law which
establishes, implements, or continues in effect any
standard or requirement solely relating to health
insurance issuers in connection with group health
insurance coverage except to the extent that such
standard or requirement prevents the application of a
requirement of this part.
(2) Continued preemption with respect to group
health plans.--Nothing in this part shall be construed
to affect or modify the provisions of section 514 of
the Employee Retirement Income Security Act of 1974
with respect to group health plans.
(b) Special Rules in Case of Portability Requirements.--
(1) In general.--Subject to paragraph (2), the
provisions of this part relating to health insurance
coverage offered by a health insurance issuer supersede
any provision of State law which establishes,
implements, or continues in effect a standard or
requirement applicable to imposition of a preexisting
condition exclusion specifically governed by section
701 which differs from the standards or requirements
specified in such section.
(2) Exceptions.--Only in relation to health
insurance coverage offered by a health insurance
issuer, the provisions of this part do not supersede
any provision of State law to the extent that such
provision--
(i) \1\ substitutes for the reference to
``6-month period'' in section 2701(a)(1) a
reference to any shorter period of time;
---------------------------------------------------------------------------
\1\ Clauses (i) through (vii) probably should be redesignated as
subparagraphs (A) through (G). See section 102(a) of Public Law 104-191
(110 Stat. 1971).
---------------------------------------------------------------------------
(ii) \1\ substitutes for the reference to
``12 months'' and ``18 months'' in section
2701(a)(2) a reference to any shorter period of
time;
(iii) \1\ substitutes for the references to
``63'' days in sections 2701(c)(2)(A) and
2701(d)(4)(A) a reference to any greater number
of days;
(iv) \1\ substitutes for the reference to
``30-day period'' in sections 2701(b)(2) and
2701(d)(1) a reference to any greater period;
(v) \1\ prohibits the imposition of any
preexisting condition exclusion in cases not
described in section 2701(d) or expands the
exceptions described in such section;
(vi) \1\ requires special enrollment
periods in addition to those required under
section 2701(f); or
(vii) \1\ reduces the maximum period
permitted in an affiliation period under
section 2701(g)(1)(B).
(c) Rules of Construction.--Nothing in this part (other
than section 2704) shall be construed as requiring a group
health plan or health insurance coverage to provide specific
benefits under the terms of such plan or coverage.
(d) Definitions.--For purposes of this section--
(1) State law.--The term ``State law'' includes all
laws, decisions, rules, regulations, or other State
action having the effect of law, of any State. A law of
the United States applicable only to the District of
Columbia shall be treated as a State law rather than a
law of the United States.
(2) State.--The term ``State'' includes a State
(including the Northern Mariana Islands), any political
subdivisions of a State or such Islands, or any agency
or instrumentality of either.
======================================================================
[Note: Effective on January 1, 2014, sections 1001, 1201,
and 1563 (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by
section 10107(b)(1)) of Public Law 111-148 provides for
amendments to provisions in part A. The conforming amendments
made by section 1563 (as so redesignated) of such Public Law to
part A take effect on date of enactment (March 23, 2010) but
have been carried to this version to reflect to probable intent
of Congress. Upon such date, part A of title XXVII reads as
follows:]
PART A--INDIVIDUAL AND GROUP MARKET REFORMS
Subpart I--General Reform
SEC. 2701. [300GG] FAIR HEALTH INSURANCE PREMIUMS.
(a) \1\ Prohibiting Discriminatory Premium Rates.--
---------------------------------------------------------------------------
\1\ There are no subsections following subsection (a) in section
2701.
---------------------------------------------------------------------------
(1) In general.--With respect to the premium rate
charged by a health insurance issuer for health
insurance coverage offered in the individual or small
group market--
(A) such rate shall vary with respect to
the particular plan or coverage involved only
by--
(i) whether such plan or coverage
covers an individual or family;
(ii) rating area, as established in
accordance with paragraph (2);
(iii) age, except that such rate
shall not vary by more than 3 to 1 for
adults (consistent with section
2707(c)); and
(iv) tobacco use, except that such
rate shall not vary by more than 1.5 to
1; and
(B) such rate shall not vary with respect
to the particular plan or coverage involved by
any other factor not described in subparagraph
(A).
(2) Rating area.--
(A) In general.--Each State shall establish
1 or more rating areas within that State for
purposes of applying the requirements of this
title.
(B) Secretarial review.--The Secretary
shall review the rating areas established by
each State under subparagraph (A) to ensure the
adequacy of such areas for purposes of carrying
out the requirements of this title. If the
Secretary determines a State's rating areas are
not adequate, or that a State does not
establish such areas, the Secretary may
establish rating areas for that State.
(3) Permissible age bands.--The Secretary, in
consultation with the National Association of Insurance
Commissioners, shall define the permissible age bands
for rating purposes under paragraph (1)(A)(iii).
(4) Application of variations based on age or
tobacco use.--With respect to family coverage under a
group health plan or health insurance coverage, the
rating variations permitted under clauses (iii) and
(iv) of paragraph (1)(A) shall be applied based on the
portion of the premium that is attributable to each
family member covered under the plan or coverage.
(5) Special rule for large group market.--If a
State permits health insurance issuers that offer
coverage in the large group market in the State to
offer such coverage through the State Exchange (as
provided for under section 1312(f)(2)(B) of the Patient
Protection and Affordable Care Act), the provisions of
this subsection shall apply to all coverage offered in
such market (other than self-insured group health plans
offered in such market) in the State.
SEC. 2702. [300GG-1] GUARANTEED AVAILABILITY OF COVERAGE.
(a) Guaranteed Issuance of Coverage in the Individual and
Group Market.--Subject to subsections (b) through (e), each
health insurance issuer that offers health insurance coverage
in the individual or group market in a State must accept every
employer and individual in the State that applies for such
coverage.
(b) Enrollment.--
(1) Restriction.--A health insurance issuer
described in subsection (a) may restrict enrollment in
coverage described in such subsection to open or
special enrollment periods.
(2) Establishment.--A health insurance issuer
described in subsection (a) shall, in accordance with
the regulations promulgated under paragraph (3),
establish special enrollment periods for qualifying
events (under section 603 of the Employee Retirement
Income Security Act of 1974).
(3) Regulations.--The Secretary shall promulgate
regulations with respect to enrollment periods under
paragraphs (1) and (2).
(c) Special Rules for Network Plans.--
(1) In general.--In the case of a health insurance
issuer that offers health insurance coverage in the
group and individual market through a network plan, the
issuer may--
(A) limit the employers that may apply for
such coverage to those with eligible
individuals who live, work, or reside in the
service area for such network plan; and
(B) within the service area of such plan,
deny such coverage to such employers and
individuals if the issuer has demonstrated, if
required, to the applicable State authority
that--
(i) it will not have the capacity
to deliver services adequately to
enrollees of any additional groups or
any additional individuals because of
its obligations to existing group
contract holders and enrollees, and
(ii) it is applying this paragraph
uniformly to all employers and
individuals without regard to the
claims experience of those individuals,
employers and their employees (and
their dependents) or any health status-
related factor relating to such
individuals employees and dependents.
(2) 180-day suspension upon denial of coverage.--An
issuer, upon denying health insurance coverage in any
service area in accordance with paragraph (1)(B), may
not offer coverage in the group or individual market
within such service area for a period of 180 days after
the date such coverage is denied.
(d) Application of Financial Capacity Limits.--
(1) In general.--A health insurance issuer may deny
health insurance coverage in the group or individual
market if the issuer has demonstrated, if required, to
the applicable State authority that--
(A) it does not have the financial reserves
necessary to underwrite additional coverage;
and
(B) it is applying this paragraph uniformly
to all employers and individuals in the group
or individual market in the State consistent
with applicable State law and without regard to
the claims experience of those individuals,
employers and their employees (and their
dependents) or any health status-related factor
relating to such individuals, employees and
dependents.
(2) 180-day suspension upon denial of coverage.--A
health insurance issuer upon denying health insurance
coverage in connection with group health plans in
accordance with paragraph (1) in a State may not offer
coverage in connection with group health plans in the
group or individual market in the State for a period of
180 days after the date such coverage is denied or
until the issuer has demonstrated to the applicable
State authority, if required under applicable State
law, that the issuer has sufficient financial reserves
to underwrite additional coverage, whichever is later.
An applicable State authority may provide for the
application of this subsection on a service-area-
specific basis.
SEC. 2703. [300GG-2] GUARANTEED RENEWABILITY OF COVERAGE.
(a) In General.--Except as provided in this section, if a
health insurance issuer offers health insurance coverage in the
individual or group market, the issuer must renew or continue
in force such coverage at the option of the plan sponsor or the
individual, as applicable.
(b) General Exceptions.--A health insurance issuer may
nonrenew or discontinue health insurance coverage offered in
connection with a health insurance coverage offered in the
group or individual market based only on one or more of the
following:
(1) Nonpayment of premiums.--The plan sponsor, or
individual, as applicable, has failed to pay premiums
or contributions in accordance with the terms of the
health insurance coverage or the issuer has not
received timely premium payments.
(2) Fraud.--The plan sponsor, or individual, as
applicable, has performed an act or practice that
constitutes fraud or made an intentional
misrepresentation of material fact under the terms of
the coverage.
(3) Violation of participation or contribution
rates.--In the case of a group health plan, the plan
sponsor has failed to comply with a material plan
provision relating to employer contribution or group
participation rules, pursuant to applicable State law.
(4) Termination of coverage.--The issuer is ceasing
to offer coverage in such market in accordance with
subsection (c) and applicable State law.
(5) Movement outside service area.--In the case of
a health insurance issuer that offers health insurance
coverage in the market through a network plan, there is
no longer any enrollee in connection with such plan who
lives, resides, or works in the service area of the
issuer (or in the area for which the issuer is
authorized to do business) and, in the case of the
small group market, the issuer would deny enrollment
with respect to such plan under section 2711(c)(1)(A).
(6) Association membership ceases.--In the case of
health insurance coverage that is made available in the
small or large group market (as the case may be) only
through one or more bona fide associations, the
membership of an employer in the association (on the
basis of which the coverage is provided) ceases but
only if such coverage is terminated under this
paragraph uniformly without regard to any health
status-related factor relating to any covered
individual.
(c) Requirements for Uniform Termination of Coverage.--
(1) Particular type of coverage not offered.--In
any case in which an issuer decides to discontinue
offering a particular type of group or individual
health insurance coverage, coverage of such type may be
discontinued by the issuer in accordance with
applicable State law in such market only if--
(A) the issuer provides notice to each plan
sponsor or individual, as applicable, provided
coverage of this type in such market (and
participants and beneficiaries covered under
such coverage) of such discontinuation at least
90 days prior to the date of the
discontinuation of such coverage;
(B) the issuer offers to each plan sponsor
or individual, as applicable, provided coverage
of this type in such market, the option to
purchase all (or, in the case of the large
group market, any) other health insurance
coverage currently being offered by the issuer
to a group health plan or individual health
insurance coverage \1\ in such market; and
---------------------------------------------------------------------------
\1\ Section 1563(c)(9)(C)(i)(III)(bb) (relating to conforming
amendments--originally designated as section 1562 and redesignated as
section 1563 by section 10107(b)(1)) of Public Law 111-148 provides for
an amendment to insert ``or individual health insurance coverage''.
Such amendment did not specify where to insert this new language,
however, it was carried out by inserting such language after ``group
health plan'' to reflect the probable intent of Congress.
---------------------------------------------------------------------------
(C) in exercising the option to discontinue
coverage of this type and in offering the
option of coverage under subparagraph (B), the
issuer acts uniformly without regard to the
claims experience of those sponsors or
individuals, as applicable, or any health
status-related factor relating to any
participants or beneficiaries covered or new
participants or beneficiaries who may become
eligible for such coverage.
(2) Discontinuance of all coverage.--
(A) In general.--In any case in which a
health insurance issuer elects to discontinue
offering all health insurance coverage in the
individual or group market, or all markets, in
a State, health insurance coverage may be
discontinued by the issuer only in accordance
with applicable State law and if--
(i) the issuer provides notice to
the applicable State authority and to
each plan sponsor or individual, as
applicable, (and participants and
beneficiaries covered under such
coverage) of such discontinuation at
least 180 days prior to the date of the
discontinuation of such coverage; and
(ii) all health insurance issued or
delivered for issuance in the State in
such market (or markets) are
discontinued and coverage under such
health insurance coverage in such
market (or markets) is not renewed.
(B) Prohibition on market reentry.--In the
case of a discontinuation under subparagraph
(A) in a market, the issuer may not provide for
the issuance of any health insurance coverage
in the market and State involved during the 5-
year period beginning on the date of the
discontinuation of the last health insurance
coverage not so renewed.
(d) Exception for Uniform Modification of Coverage.--At the
time of coverage renewal, a health insurance issuer may modify
the health insurance coverage for a product offered to a group
health plan--
(1) in the large group market; or
(2) in the small group market if, for coverage that
is available in such market other than only through one
or more bona fide associations, such modification is
consistent with State law and effective on a uniform
basis among group health plans with that product.
(e) Application to Coverage Offered Only Through
Associations.--In applying this section in the case of health
insurance coverage that is made available by a health insurance
issuer in the small or large group market to employers only
through one or more associations, a reference to ``plan
sponsor'' is deemed, with respect to coverage provided to an
employer member of the association, to include a reference to
such employer.
SEC. 2704. [300GG-3] PROHIBITION OF PREEXISTING CONDITION EXCLUSIONS OR
OTHER DISCRIMINATION BASED ON HEALTH STATUS.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
may not impose any preexisting condition exclusion with respect
to such plan or coverage.
(b) Definitions.--For purposes of this part--
(1) Preexisting condition exclusion.--
(A) In general.--The term ``preexisting
condition exclusion'' means, with respect to
coverage, a limitation or exclusion of benefits
relating to a condition based on the fact that
the condition was present before the date of
enrollment for such coverage, whether or not
any medical advice, diagnosis, care, or
treatment was recommended or received before
such date.
(B) Treatment of genetic information.--
Genetic information shall not be treated as a
condition described in subsection (a)(1) in the
absence of a diagnosis of the condition related
to such information.
(2) Enrollment date.--The term ``enrollment date''
means, with respect to an individual covered under a
group health plan or health insurance coverage, the
date of enrollment of the individual in the plan or
coverage or, if earlier, the first day of the waiting
period for such enrollment.
(3) Late enrollee.--The term ``late enrollee''
means, with respect to coverage under a group health
plan, a participant or beneficiary who enrolls under
the plan other than during--
(A) the first period in which the
individual is eligible to enroll under the
plan, or
(B) a special enrollment period under
subsection (f).
(4) Waiting period.--The term ``waiting period''
means, with respect to a group health plan and an
individual who is a potential participant or
beneficiary in the plan, the period that must pass with
respect to the individual before the individual is
eligible to be covered for benefits under the terms of
the plan.
(c) Rules Relating to Crediting Previous Coverage.--
(1) Creditable coverage defined.--For purposes of
this title, the term ``creditable coverage'' means,
with respect to an individual, coverage of the
individual under any of the following:
(A) A group health plan.
(B) Health insurance coverage.
(C) Part A or part B of title XVIII of the
Social Security Act.
(D) Title XIX of the Social Security Act,
other than coverage consisting solely of
benefits under section 1928.
(E) Chapter 55 of title 10, United States
Code.
(F) A medical care program of the Indian
Health Service or of a tribal organization.
(G) A State health benefits risk pool.
(H) A health plan offered under chapter 89
of
title 5, United States Code.
(I) A public health plan (as defined in
regulations).
(J) A health benefit plan under section
5(e) of the Peace Corps Act (22 U.S.C.
2504(e)).
Such term does not include coverage consisting solely
of coverage of excepted benefits (as defined in section
2791(c)).
(2) Not counting periods before significant breaks
in coverage.--
(A) In general.--A period of creditable
coverage shall not be counted, with respect to
enrollment of an individual under a group or
individual health plan, if, after such period
and before the enrollment date, there was a 63-
day period during all of which the individual
was not covered under any creditable coverage.
(B) Waiting period not treated as a break
in coverage.--For purposes of subparagraph (A)
and subsection (d)(4), any period that an
individual is in a waiting period for any
coverage under a group or individual health
plan (or for group health insurance coverage)
or is in an affiliation period (as defined in
subsection (g)(2)) shall not be taken into
account in determining the continuous period
under subparagraph (A).
(C) TAA-eligible individuals.--In the case
of plan years beginning before January 1,
2011--
(i) TAA pre-certification period
rule.--In the case of a TAA-eligible
individual, the period beginning on the
date the individual has a TAA-related
loss of coverage and ending on the date
that is 7 days after the date of the
issuance by the Secretary (or by any
person or entity designated by the
Secretary) of a qualified health
insurance costs credit eligibility
certificate for such individual for
purposes of section 7527 of the
Internal Revenue Code of 1986 shall not
be taken into account in determining
the continuous period under
subparagraph (A).
(ii) Definitions.--The terms ``TAA-
eligible individual'' and ``TAA-related
loss of coverage'' have the meanings
given such terms in section 2205(b)(4).
(3) Method of crediting coverage.--
(A) Standard method.--Except as otherwise
provided under subparagraph (B), for purposes
of applying subsection (a)(3), a group health
plan, and a health insurance issuer offering
group or individual health insurance coverage,
shall count a period of creditable coverage
without regard to the specific benefits covered
during the period.
(B) Election of alternative method.--A
group health plan, or a health insurance issuer
offering group or individual health insurance,
may elect to apply subsection (a)(3) based on
coverage of benefits within each of several
classes or categories of benefits specified in
regulations rather than as provided under
subparagraph (A). Such election shall be made
on a uniform basis for all participants and
beneficiaries. Under such election a group or
individual health plan or issuer shall count a
period of creditable coverage with respect to
any class or category of benefits if any level
of benefits is covered within such class or
category.
(C) Plan notice.--In the case of an
election with respect to a group health plan
under subparagraph (B) (whether or not health
insurance coverage is provided in connection
with such plan), the plan shall--
(i) prominently state in any
disclosure statements concerning the
plan, and state to each enrollee at the
time of enrollment under the plan, that
the plan has made such election, and
(ii) include in such statements a
description of the effect of this
election.
(D) Issuer notice.--In the case of an
election under subparagraph (B) with respect to
health insurance coverage offered by an issuer
in the individual or group group \1\ market,
the issuer--
---------------------------------------------------------------------------
\1\ So in law. See amendment made by section 1563(c)(1)(A)(ii)(II)
(relating to conforming amendments--originally designated as section
1562 and redesignated as section 1563 by section 10107(b)(1)) of Public
Law 111-148.
---------------------------------------------------------------------------
(i) shall prominently state in any
disclosure statements concerning the
coverage, and to each employer at the
time of the offer or sale of the
coverage, that the issuer has made such
election, and
(ii) shall include in such
statements a description of the effect
of such election.
(4) Establishment of period.--Periods of creditable
coverage with respect to an individual shall be
established through presentation of certifications
described in subsection (e) or in such other manner as
may be specified in regulations.
(d) Exceptions.--
(1) Exclusion not applicable to certain newborns.--
Subject to paragraph (4), a group health plan, and a
health insurance issuer offering group or individual
health insurance coverage, may not impose any
preexisting condition exclusion in the case of an
individual who, as of the last day of the 30-day period
beginning with the date of birth, is covered under
creditable coverage.
(2) Exclusion not applicable to certain adopted
children.--Subject to paragraph (4), a group health
plan, and a health insurance issuer offering group or
individual health insurance coverage, may not impose
any preexisting condition exclusion in the case of a
child who is adopted or placed for adoption before
attaining 18 years of age and who, as of the last day
of the 30-day period beginning on the date of the
adoption or placement for adoption, is covered under
creditable coverage. The previous sentence shall not
apply to coverage before the date of such adoption or
placement for adoption.
(3) Exclusion not applicable to pregnancy.--A group
health plan, and health insurance issuer offering group
or individual health insurance coverage, may not impose
any preexisting condition exclusion relating to
pregnancy as a preexisting condition.
(4) Loss if break in coverage.--Paragraphs (1) and
(2) shall no longer apply to an individual after the
end of the first 63-day period during all of which the
individual was not covered under any creditable
coverage.
(e) Certifications and Disclosure of Coverage.--
(1) Requirement for certification of period of
creditable coverage.--
(A) In general.--A group health plan, and a
health insurance issuer offering group or
individual health insurance coverage, shall
provide the certification described in
subparagraph (B)--
(i) at the time an individual
ceases to be covered under the plan or
otherwise becomes covered under a COBRA
continuation provision,
(ii) in the case of an individual
becoming covered under such a
provision, at the time the individual
ceases to be covered under such
provision, and
(iii) on the request on behalf of
an individual made not later than 24
months after the date of cessation of
the coverage described in clause (i) or
(ii), whichever is later.
The certification under clause (i) may be
provided, to the extent practicable, at a time
consistent with notices required under any
applicable COBRA continuation provision.
(B) Certification.--The certification
described in this subparagraph is a written
certification of--
(i) the period of creditable
coverage of the individual under such
plan and the coverage (if any) under
such COBRA continuation provision, and
(ii) the waiting period (if any)
(and affiliation period, if applicable)
imposed with respect to the individual
for any coverage under such plan.
(C) Issuer compliance.--To the extent that
medical care under a group health plan consists
of group health insurance coverage, the plan is
deemed to have satisfied the certification
requirement under this paragraph if the health
insurance issuer offering the coverage provides
for such certification in accordance with this
paragraph.
(2) Disclosure of information on previous
benefits.--In the case of an election described in
subsection (c)(3)(B) by a group health plan or health
insurance issuer, if the plan or issuer enrolls an
individual for coverage under the plan and the
individual provides a certification of coverage of the
individual under paragraph (1)--
(A) upon request of such plan or issuer,
the entity which issued the certification
provided by the individual shall promptly
disclose to such requesting plan or issuer
information on coverage of classes and
categories of health benefits available under
such entity's plan or coverage, and
(B) such entity may charge the requesting
plan or issuer for the reasonable cost of
disclosing such information.
(3) Regulations.--The Secretary shall establish
rules to prevent an entity's failure to provide
information under paragraph (1) or (2) with respect to
previous coverage of an individual from adversely
affecting any subsequent coverage of the individual
under another group health plan or health insurance
coverage.
(f) Special Enrollment Periods.--
(1) Individuals losing other coverage.--A group
health plan, and a health insurance issuer offering
group health insurance coverage in connection with a
group health plan, shall permit an employee who is
eligible, but not enrolled, for coverage under the
terms of the plan (or a dependent of such an employee
if the dependent is eligible, but not enrolled, for
coverage under such terms) to enroll for coverage under
the terms of the plan if each of the following
conditions is met:
(A) The employee or dependent was covered
under a group health plan or had health
insurance coverage at the time coverage was
previously offered to the employee or
dependent.
(B) The employee stated in writing at such
time that coverage under a group health plan or
health insurance coverage was the reason for
declining enrollment, but only if the plan
sponsor or issuer (if applicable) required such
a statement at such time and provided the
employee with notice of such requirement (and
the consequences of such requirement) at such
time.
(C) The employee's or dependent's coverage
described in subparagraph (A)--
(i) was under a COBRA continuation
provision and the coverage under such
provision was
exhausted; or
(ii) was not under such a provision
and either the coverage was terminated
as a result of loss of eligibility for
the coverage (including as a result of
legal separation, divorce, death,
termination of employment, or reduction
in the number of hours of employment)
or employer contributions toward such
coverage were terminated.
(D) Under the terms of the plan, the
employee requests such enrollment not later
than 30 days after the date of exhaustion of
coverage described in subparagraph (C)(i) or
termination of coverage or employer
contribution described in subparagraph (C)(ii).
(2) For dependent beneficiaries.--
(A) In general.--If--
(i) a group health plan makes
coverage available with respect to a
dependent of an individual,
(ii) the individual is a
participant under the plan (or has met
any waiting period applicable to
becoming a participant under the plan
and is eligible to be enrolled under
the plan but for a failure to enroll
during a previous enrollment period),
and
(iii) a person becomes such a
dependent of the individual through
marriage, birth, or adoption or
placement for adoption,
the group health plan shall provide for a
dependent special enrollment period described
in subparagraph (B) during which the person
(or, if not otherwise enrolled, the individual)
may be enrolled under the plan as a dependent
of the individual, and in the case of the birth
or adoption of a child, the spouse of the
individual may be enrolled as a dependent of
the individual if such spouse is otherwise
eligible for coverage.
(B) Dependent special enrollment period.--A
dependent special enrollment period under this
subparagraph shall be a period of not less than
30 days and shall begin on the later of--
(i) the date dependent coverage is
made
available, or
(ii) the date of the marriage,
birth, or adoption or placement for
adoption (as the case may be) described
in subparagraph (A)(iii).
(C) No waiting period.--If an individual
seeks to enroll a dependent during the first 30
days of such a dependent special enrollment
period, the coverage of the dependent shall
become effective--
(i) in the case of marriage, not
later than the first day of the first
month beginning after the date the
completed request for enrollment is
received;
(ii) in the case of a dependent's
birth, as of the date of such birth; or
(iii) in the case of a dependent's
adoption or placement for adoption, the
date of such adoption or placement for
adoption.
(3) Special rules for application in case of
medicaid and chip.--
(A) In general.--A group health plan, and a
health insurance issuer offering group health
insurance coverage in connection with a group
health plan, shall permit an employee who is
eligible, but not enrolled, for coverage under
the terms of the plan (or a dependent of such
an employee if the dependent is eligible, but
not enrolled, for coverage under such terms) to
enroll for coverage under the terms of the plan
if either of the following conditions is met:
(i) Termination of medicaid or chip
coverage.--The employee or dependent is
covered under a Medicaid plan under
title XIX of the Social Security Act or
under a State child health plan under
title XXI of such Act and coverage of
the employee or dependent under such a
plan is terminated as a result of loss
of eligibility for such coverage and
the employee requests coverage under
the group health plan (or health
insurance coverage) not later than 60
days after the date of termination of
such coverage.
(ii) Eligibility for employment
assistance under medicaid or chip.--The
employee or dependent becomes eligible
for assistance, with respect to
coverage under the group health plan or
health insurance coverage, under such
Medicaid plan or State child health
plan (including under any waiver or
demonstration project conducted under
or in relation to such a plan), if the
employee requests coverage under the
group health plan or health insurance
coverage not later than 60 days after
the date the employee or dependent is
determined to be eligible for such
assistance.
(B) Coordination with medicaid and chip.--
(i) Outreach to employees regarding
availability of medicaid and chip
coverage.--
(I) In general.--Each
employer that maintains a group
health plan in a State that
provides medical assistance
under a State Medicaid plan
under title XIX of the Social
Security Act, or child health
assistance under a State child
health plan under title XXI of
such Act, in the form of
premium assistance for the
purchase of coverage under a
group health plan, shall
provide to each employee a
written notice informing the
employee of potential
opportunities then currently
available in the State in which
the employee resides for
premium assistance under such
plans for health coverage of
the employee or the employee's
dependents. For purposes of
compliance with this subclause,
the employer may use any State-
specific model notice developed
in accordance with section
701(f)(3)(B)(i)(II) of the
Employee Retirement Income
Security Act of 1974 (29 U.S.C.
1181(f)(3)(B)(i)(II)).
(II) Option to provide
concurrent with provision of
plan materials to employee.--An
employer may provide the model
notice applicable to the State
in which an employee resides
concurrent with the furnishing
of materials notifying the
employee of health plan
eligibility, concurrent with
materials provided to the
employee in connection with an
open season or election process
conducted under the plan, or
concurrent with the furnishing
of the summary plan description
as provided in section 104(b)
of the Employee Retirement
Income Security Act of 1974.
(ii) Disclosure about group health
plan benefits to states for medicaid
and chip eligible individuals.--In the
case of an enrollee in a group health
plan who is covered under a Medicaid
plan of a State under title XIX of the
Social Security Act or under a State
child health plan under title XXI of
such Act, the plan administrator of the
group health plan shall disclose to the
State, upon request, information about
the benefits available under the group
health plan in sufficient specificity,
as determined under regulations of the
Secretary of Health and Human Services
in consultation with the Secretary that
require use of the model coverage
coordination disclosure form developed
under section 311(b)(1)(C) of the
Children's Health Insurance
Reauthorization Act of 2009, so as to
permit the State to make a
determination (under paragraph (2)(B),
(3), or (10) of section 2105(c) of the
Social Security Act or otherwise)
concerning the cost-effectiveness of
the State providing medical or child
health assistance through premium
assistance for the purchase of coverage
under such group health plan and in
order for the State to provide
supplemental benefits required under
paragraph (10)(E) of such section or
other authority.
(g) Use of Affiliation Period by HMOs as Alternative to
Preexisting Condition Exclusion.--
(1) In general.--A health maintenance organization
which offers health insurance coverage in connection
with a group health plan and which does not impose any
preexisting condition exclusion allowed under
subsection (a) with respect to any particular coverage
option may impose an affiliation period for such
coverage option, but only if--
(A) such period is applied uniformly
without regard to any health status-related
factors; and
(B) such period does not exceed 2 months
(or 3 months in the case of a late enrollee).
(2) Affiliation period.--
(A) Defined.--For purposes of this title,
the term ``affiliation period'' means a period
which, under the terms of the health insurance
coverage offered by the health maintenance
organization, must expire before the health
insurance coverage becomes effective. The
organization is not required to provide health
care services or benefits during such period
and no premium shall be charged to the
participant or beneficiary for any coverage
during the period.
(B) Beginning.--Such period shall begin on
the enrollment date.
(C) Runs concurrently with waiting
periods.--An affiliation period under a plan
shall run concurrently with any waiting period
under the plan.
(3) Alternative methods.--A health maintenance
organization described in paragraph (1) may use
alternative methods, from those described in such
paragraph, to address adverse selection as approved by
the State insurance commissioner or official or
officials designated by the State to enforce the
requirements of this part for the State involved with
respect to such issuer.
SEC. 2705. [300GG-4] PROHIBITING DISCRIMINATION AGAINST INDIVIDUAL
PARTICIPANTS AND BENEFICIARIES BASED ON HEALTH
STATUS.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
may not establish rules for eligibility (including continued
eligibility) of any individual to enroll under the terms of the
plan or coverage based on any of the following health status-
related factors in relation to the individual or a dependent of
the individual:
(1) Health status.
(2) Medical condition (including both physical and
mental illnesses).
(3) Claims experience.
(4) Receipt of health care.
(5) Medical history.
(6) Genetic information.
(7) Evidence of insurability (including conditions
arising out of acts of domestic violence).
(8) Disability.
(9) Any other health status-related factor
determined appropriate by the Secretary.
(b) In Premium Contributions.--
(1) In general.--A group health plan, and a health
insurance issuer offering group or individual health
insurance coverage, may not require any individual (as
a condition of enrollment or continued enrollment under
the plan) to pay a premium or contribution which is
greater than such premium or contribution for a
similarly situated individual enrolled in the plan on
the basis of any health status-related factor in
relation to the individual or to an individual enrolled
under the plan as a dependent of the individual.
(2) Construction.--Nothing in paragraph (1) shall
be construed--
(A) to restrict the amount that an employer
or individual may be charged for coverage under
a group health plan except as provided in
paragraph (3) or individual health coverage, as
the case may be; or
(B) to prevent a group health plan, and a
health insurance issuer offering group health
insurance coverage, from establishing premium
discounts or rebates or modifying otherwise
applicable copayments or deductibles in return
for adherence to programs of health promotion
and disease prevention.
(3) No group-based discrimination on basis of
genetic information.--
(A) In general.--For purposes of this
section, a group health plan, and health
insurance issuer offering group or individual
health insurance coverage, may not adjust
premium or contribution amounts for the group
covered under such plan on the basis of genetic
information.
(B) Rule of construction.--Nothing in
subparagraph (A) or in paragraphs (1) and (2)
of subsection (d) shall be construed to limit
the ability of a health insurance issuer
offering group or individual health insurance
coverage to increase the premium for an
employer based on the manifestation of a
disease or disorder of an individual who is
enrolled in the plan. In such case, the
manifestation of a disease or disorder in one
individual cannot also be used as genetic
information about other group members and to
further increase the premium for the employer.
(c) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A group health plan, and a health insurance
issuer offering health insurance coverage in connection
with a group health plan, shall not request or require
an individual or a family member of such individual to
undergo a genetic test.
(2) Rule of construction.--Paragraph (1) shall not
be construed to limit the authority of a health care
professional who is providing health care services to
an individual to request that such individual undergo a
genetic test.
(3) Rule of construction regarding payment.--
(A) In general.--Nothing in paragraph (1)
shall be construed to preclude a group health
plan, or a health insurance issuer offering
health insurance coverage in connection with a
group health plan, from obtaining and using the
results of a genetic test in making a
determination regarding payment (as such term
is defined for the purposes of applying the
regulations promulgated by the Secretary under
part C of title XI of the Social Security Act
and section 264 of the Health Insurance
Portability and Accountability Act of 1996, as
may be revised from time to time) consistent
with subsection (a).
(B) Limitation.--For purposes of
subparagraph (A), a group health plan, or a
health insurance issuer offering health
insurance coverage in connection with a group
health plan, may request only the minimum
amount of information necessary to accomplish
the intended purpose.
(4) Research exception.--Notwithstanding paragraph
(1), a group health plan, or a health insurance issuer
offering health insurance coverage in connection with a
group health plan, may request, but not require, that a
participant or beneficiary undergo a genetic test if
each of the following conditions is met:
(A) The request is made pursuant to
research that complies with part 46 of title
45, Code of Federal Regulations, or equivalent
Federal regulations, and any applicable State
or local law or regulations for the protection
of human subjects in research.
(B) The plan or issuer clearly indicates to
each participant or beneficiary, or in the case
of a minor child, to the legal guardian of such
beneficiary, to whom the request is made that--
(i) compliance with the request is
voluntary; and
(ii) non-compliance will have no
effect on enrollment status or premium
or contribution amounts.
(C) No genetic information collected or
acquired under this paragraph shall be used for
underwriting purposes.
(D) The plan or issuer notifies the
Secretary in writing that the plan or issuer is
conducting activities pursuant to the exception
provided for under this paragraph, including a
description of the activities conducted.
(E) The plan or issuer complies with such
other conditions as the Secretary may by
regulation require for activities conducted
under this paragraph.
(d) Prohibition on Collection of Genetic Information.--
(1) In general.--A group health plan, and a health
insurance issuer offering health insurance coverage in
connection with a group health plan, shall not request,
require, or purchase genetic information for
underwriting purposes (as defined in section 2791).
(2) Prohibition on collection of genetic
information prior to enrollment.--A group health plan,
and a health insurance issuer offering health insurance
coverage in connection with a group health plan, shall
not request, require, or purchase genetic information
with respect to any individual prior to such
individual's enrollment under the plan or coverage in
connection with such enrollment.
(3) Incidental collection.--If a group health plan,
or a health insurance issuer offering health insurance
coverage in connection with a group health plan,
obtains genetic information incidental to the
requesting, requiring, or purchasing of other
information concerning any individual, such request,
requirement, or purchase shall not be considered a
violation of paragraph (2) if such request,
requirement, or purchase is not in violation of
paragraph (1).
(e) Application to All Plans.--The provisions of
subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1)
and section 2704 with respect to genetic information, shall
apply to group health plans and health insurance issuers
without regard to section 2735(a).
(f) Genetic Information of a Fetus or Embryo.--Any
reference in this part to genetic information concerning an
individual or family member of an individual shall--
(1) with respect to such an individual or family
member of an individual who is a pregnant woman,
include genetic information of any fetus carried by
such pregnant woman; and
(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include
genetic information of any embryo legally held by the
individual or family member.
(j) \1\ Programs of Health Promotion or Disease
Prevention.--
---------------------------------------------------------------------------
\1\ So in law. There are no subsections (g)-(i).
---------------------------------------------------------------------------
(1) General provisions.--
(A) General rule.--For purposes of
subsection (b)(2)(B), a program of health
promotion or disease prevention (referred to in
this subsection as a ``wellness program'')
shall be a program offered by an employer that
is designed to promote health or prevent
disease that meets the applicable requirements
of this subsection.
(B) No conditions based on health status
factor.--If none of the conditions for
obtaining a premium discount or rebate or other
reward for participation in a wellness program
is based on an individual satisfying a standard
that is related to a health status factor, such
wellness program shall not violate this section
if participation in the program is made
available to all similarly situated individuals
and the requirements of paragraph (2) are
complied with.
(C) Conditions based on health status
factor.--If any of the conditions for obtaining
a premium discount or rebate or other reward
for participation in a wellness program is
based on an individual satisfying a standard
that is related to a health status factor, such
wellness program shall not violate this section
if the requirements of paragraph (3) are
complied with.
(2) Wellness programs not subject to
requirements.--If none of the conditions for obtaining
a premium discount or rebate or other reward under a
wellness program as described in paragraph (1)(B) are
based on an individual satisfying a standard that is
related to a health status factor (or if such a
wellness program does not provide such a reward), the
wellness program shall not violate this section if
participation in the program is made available to all
similarly situated individuals. The following programs
shall not have to comply with the requirements of
paragraph (3) if participation in the program is made
available to all similarly situated individuals:
(A) A program that reimburses all or part
of the cost for memberships in a fitness
center.
(B) A diagnostic testing program that
provides a reward for participation and does
not base any part of the reward on outcomes.
(C) A program that encourages preventive
care related to a health condition through the
waiver of the copayment or deductible
requirement under group health plan for the
costs of certain items or services related to a
health condition (such as prenatal care or
well-baby visits).
(D) A program that reimburses individuals
for the costs of smoking cessation programs
without regard to whether the individual quits
smoking.
(E) A program that provides a reward to
individuals for attending a periodic health
education seminar.
(3) Wellness programs subject to requirements.--If
any of the conditions for obtaining a premium discount,
rebate, or reward under a wellness program as described
in paragraph (1)(C) is based on an individual
satisfying a standard that is related to a health
status factor, the wellness program shall not violate
this section if the following requirements are complied
with:
(A) The reward for the wellness program,
together with the reward for other wellness
programs with respect to the plan that requires
satisfaction of a standard related to a health
status factor, shall not exceed 30 percent of
the cost of employee-only coverage under the
plan. If, in addition to employees or
individuals, any class of dependents (such as
spouses or spouses and dependent children) may
participate fully in the wellness program, such
reward shall not exceed 30 percent of the cost
of the coverage in which an employee or
individual and any dependents are enrolled. For
purposes of this paragraph, the cost of
coverage shall be determined based on the total
amount of employer and employee contributions
for the benefit package under which the
employee is (or the employee and any dependents
are) receiving coverage. A reward may be in the
form of a discount or rebate of a premium or
contribution, a waiver of all or part of a
cost-sharing mechanism (such as deductibles,
copayments, or coinsurance), the absence of a
surcharge, or the value of a benefit that would
otherwise not be provided under the plan. The
Secretaries of Labor, Health and Human
Services, and the Treasury may increase the
reward available under this subparagraph to up
to 50 percent of the cost of coverage if the
Secretaries determine that such an increase is
appropriate.
(B) The wellness program shall be
reasonably designed to promote health or
prevent disease. A program complies with the
preceding sentence if the program has a
reasonable chance of improving the health of,
or preventing disease in, participating
individuals and it is not overly burdensome, is
not a subterfuge for discriminating based on a
health status factor, and is not highly suspect
in the method chosen to promote health or
prevent disease.
(C) The plan shall give individuals
eligible for the program the opportunity to
qualify for the reward under the program at
least once each year.
(D) The full reward under the wellness
program shall be made available to all
similarly situated individuals. For such
purpose, among other things:
(i) The reward is not available to
all similarly situated individuals for
a period unless the wellness program
allows--
(I) for a reasonable
alternative standard (or waiver
of the otherwise applicable
standard) for obtaining the
reward for any individual for
whom, for that period, it is
unreasonably difficult due to a
medical condition to satisfy
the otherwise applicable
standard; and
(II) for a reasonable
alternative standard (or waiver
of the otherwise applicable
standard) for obtaining the
reward for any individual for
whom, for that period, it is
medically inadvisable to
attempt to satisfy the
otherwise applicable standard.
(ii) If reasonable under the
circumstances, the plan or issuer may
seek verification, such as a statement
from an individual's physician, that a
health status factor makes it
unreasonably difficult or medically
inadvisable for the individual to
satisfy or attempt to satisfy the
otherwise applicable standard.
(E) The plan or issuer involved shall
disclose in all plan materials describing the
terms of the wellness program the availability
of a reasonable alternative standard (or the
possibility of waiver of the otherwise
applicable standard) required under
subparagraph (D). If plan materials disclose
that such a program is available, without
describing its terms, the disclosure under this
subparagraph shall not be required.
(k) Existing Programs.--Nothing in this section shall
prohibit a program of health promotion or disease prevention
that was established prior to the date of enactment of this
section and applied with all applicable regulations, and that
is operating on such date, from continuing to be carried out
for as long as such regulations remain in effect.
(l) Wellness Program Demonstration Project.--
(1) In general.--Not later than July 1, 2014, the
Secretary, in consultation with the Secretary of the
Treasury and the Secretary of Labor, shall establish a
10-State demonstration project under which
participating States shall apply the provisions of
subsection (j) to programs of health promotion offered
by a health insurance issuer that offers health
insurance coverage in the individual market in such
State.
(2) Expansion of demonstration project.--If the
Secretary, in consultation with the Secretary of the
Treasury and the Secretary of Labor, determines that
the demonstration project described in paragraph (1) is
effective, such Secretaries may, beginning on July 1,
2017 expand such demonstration project to include
additional participating States.
(3) Requirements.--
(A) Maintenance of coverage.--The
Secretary, in consultation with the Secretary
of the Treasury and the Secretary of Labor,
shall not approve the participation of a State
in the demonstration project under this section
unless the Secretaries determine that the
State's project is designed in a manner that--
(i) will not result in any decrease
in coverage; and
(ii) will not increase the cost to
the Federal Government in providing
credits under section 36B of the
Internal Revenue Code of 1986 or cost-
sharing assistance under section 1402
of the Patient Protection and
Affordable Care Act.
(B) Other requirements.--States that
participate in the demonstration project under
this subsection--
(i) may permit premium discounts or
rebates or the modification of
otherwise applicable copayments or
deductibles for adherence to, or
participation in, a reasonably designed
program of health promotion and disease
prevention;
(ii) shall ensure that requirements
of consumer protection are met in
programs of health promotion in the
individual market;
(iii) shall require verification
from health insurance issuers that
offer health insurance coverage in the
individual market of such State that
premium discounts--
(I) do not create undue
burdens for individuals insured
in the individual market;
(II) do not lead to cost
shifting; and
(III) are not a subterfuge
for discrimination;
(iv) shall ensure that consumer
data is protected in accordance with
the requirements of section 264(c) of
the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C.
1320d-2 note); and
(v) shall ensure and demonstrate to
the satisfaction of the Secretary that
the discounts or other rewards provided
under the project reflect the expected
level of participation in the wellness
program involved and the anticipated
effect the program will have on
utilization or medical claim costs.
(m) Report.--
(1) In general.--Not later than 3 years after the
date of enactment of the Patient Protection and
Affordable Care Act, the Secretary, in consultation
with the Secretary of the Treasury and the Secretary of
Labor, shall submit a report to the appropriate
committees of Congress concerning--
(A) the effectiveness of wellness programs
(as defined in subsection (j)) in promoting
health and preventing disease;
(B) the impact of such wellness programs on
the access to care and affordability of
coverage for participants and non-participants
of such programs;
(C) the impact of premium-based and cost-
sharing incentives on participant behavior and
the role of such programs in changing behavior;
and
(D) the effectiveness of different types of
rewards.
(2) Data collection.--In preparing the report
described in paragraph (1), the Secretaries shall
gather relevant information from employers who provide
employees with access to wellness programs, including
State and Federal agencies.
(n) Regulations.--Nothing in this section shall be
construed as prohibiting the Secretaries of Labor, Health and
Human Services, or the Treasury from promulgating regulations
in connection with this section.
SEC. 2706. [300GG-5] NON-DISCRIMINATION IN HEALTH CARE.
(a) Providers.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
shall not discriminate with respect to participation under the
plan or coverage against any health care provider who is acting
within the scope of that provider's license or certification
under applicable State law. This section shall not require that
a group health plan or health insurance issuer contract with
any health care provider willing to abide by the terms and
conditions for participation established by the plan or issuer.
Nothing in this section shall be construed as preventing a
group health plan, a health insurance issuer, or the Secretary
from establishing varying reimbursement rates based on quality
or performance measures.
(b) Individuals.--The provisions of section 1558 of the
Patient Protection and Affordable Care Act (relating to non-
discrimination) shall apply with respect to a group health plan
or health insurance issuer offering group or individual health
insurance coverage.
SEC. 2707. [300GG-6] COMPREHENSIVE HEALTH INSURANCE COVERAGE.
(a) Coverage for Essential Health Benefits Package.--A
health insurance issuer that offers health insurance coverage
in the individual or small group market shall ensure that such
coverage includes the essential health benefits package
required under section 1302(a) of the Patient Protection and
Affordable Care Act.
(b) Cost-sharing Under Group Health Plans.--A group health
plan shall ensure that any annual cost-sharing imposed under
the plan does not exceed the limitations provided for under
paragraphs (1) and (2) of section 1302(c).
(c) Child-only Plans.--If a health insurance issuer offers
health insurance coverage in any level of coverage specified
under section 1302(d) of the Patient Protection and Affordable
Care Act, the issuer shall also offer such coverage in that
level as a plan in which the only enrollees are individuals
who, as of the beginning of a plan year, have not attained the
age of 21.
(d) Dental Only.--This section shall not apply to a plan
described in section 1302(d)(2)(B)(ii)(I).
SEC. 2708. [300GG-7] PROHIBITION ON EXCESSIVE WAITING PERIODS.
A group health plan and a health insurance issuer offering
group health insurance coverage shall not apply any waiting
period (as defined in section 2704(b)(4)) that exceeds 90 days.
SEC. 2709. [300GG-8] COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED
CLINICAL TRIALS. \1\
---------------------------------------------------------------------------
\1\ So in law. There are two section 2709's. The first section 2709
(relating Disclosure of Information), was former section 2713, which
was then redesignated as 2733 (by section 1001(3) of Public Law 111-
148), then redesignated again to section 2709 and transfered to appear
after section 2708 (by section 1563(c)(10)(C) (relating to conforming
amendments--originally designated as section 1562 and redesignated as
section 1563 by section 10107(b)(1)) of such Public Law).
---------------------------------------------------------------------------
(a) Coverage.--
(1) In general.--If a group health plan or a health
insurance issuer offering group or individual health
insurance coverage provides coverage to a qualified
individual, then such plan or issuer--
(A) may not deny the individual
participation in the clinical trial referred to
in subsection (b)(2);
(B) subject to subsection (c), may not deny
(or limit or impose additional conditions on)
the coverage of routine patient costs for items
and services furnished in connection with
participation in the trial; and
(C) may not discriminate against the
individual on the basis of the individual's
participation in such trial.
(2) Routine patient costs.--
(A) Inclusion.--For purposes of paragraph
(1)(B), subject to subparagraph (B), routine
patient costs include all items and services
consistent with the coverage provided in the
plan (or coverage) that is typically covered
for a qualified individual who is not enrolled
in a clinical trial.
(B) Exclusion.--For purposes of paragraph
(1)(B), routine patient costs does not
include--
(i) the investigational item,
device, or service, itself;
(ii) items and services that are
provided solely to satisfy data
collection and analysis needs and that
are not used in the direct clinical
management of the patient; or
(iii) a service that is clearly
inconsistent with widely accepted and
established standards of care for a
particular diagnosis.
(3) Use of in-network providers.--If one or more
participating providers is participating in a clinical
trial, nothing in paragraph (1) shall be construed as
preventing a plan or issuer from requiring that a
qualified individual participate in the trial through
such a participating provider if the provider will
accept the individual as a participant in the trial.
(4) Use of out-of-network.--Notwithstanding
paragraph (3), paragraph (1) shall apply to a qualified
individual participating in an approved clinical trial
that is conducted outside the State in which the
qualified individual resides.
(b) Qualified Individual Defined.--For purposes of
subsection (a), the term ``qualified individual'' means an
individual who is a participant or beneficiary in a health plan
or with coverage described in subsection (a)(1) and who meets
the following conditions:
(1) The individual is eligible to participate in an
approved clinical trial according to the trial protocol
with respect to treatment of cancer or other life-
threatening disease or condition.
(2) Either--
(A) the referring health care professional
is a participating health care provider and has
concluded that the individual's participation
in such trial would be appropriate based upon
the individual meeting the conditions described
in paragraph (1); or
(B) the participant or beneficiary provides
medical and scientific information establishing
that the individual's participation in such
trial would be appropriate based upon the
individual meeting the conditions described in
paragraph (1).
(c) Limitations on Coverage.--This section shall not be
construed to require a group health plan, or a health insurance
issuer offering group or individual health insurance coverage,
to provide benefits for routine patient care services provided
outside of the plan's (or coverage's) health care provider
network unless out-of-network benefits are otherwise provided
under the plan (or coverage).
(d) Approved Clinical Trial Defined.--
(1) In general.--In this section, the term
``approved clinical trial'' means a phase I, phase II,
phase III, or phase IV clinical trial that is conducted
in relation to the prevention, detection, or treatment
of cancer or other life-threatening disease or
condition and is described in any of the following
subparagraphs:
(A) Federally funded trials.--The study or
investigation is approved or funded (which may
include funding through in-kind contributions)
by one or more of the following:
(i) The National Institutes of
Health.
(ii) The Centers for Disease
Control and Prevention.
(iii) The Agency for Health Care
Research and Quality.
(iv) The Centers for Medicare &
Medicaid Services.
(v) cooperative group or center of
any of the entities described in
clauses (i) through (iv) or the
Department of Defense or the Department
of Veterans Affairs.
(vi) A qualified non-governmental
research entity identified in the
guidelines issued by the National
Institutes of Health for center support
grants.
(vii) Any of the following if the
conditions described in paragraph (2)
are met:
(I) The Department of
Veterans Affairs.
(II) The Department of
Defense.
(III) The Department of
Energy.
(B) The study or investigation is conducted
under an investigational new drug application
reviewed by the Food and Drug Administration.
(C) The study or investigation is a drug
trial that is exempt from having such an
investigational new drug application.
(2) Conditions for departments.--The conditions
described in this paragraph, for a study or
investigation conducted by a Department, are that the
study or investigation has been reviewed and approved
through a system of peer review that the Secretary
determines--
(A) to be comparable to the system of peer
review of studies and investigations used by
the National Institutes of Health, and
(B) assures unbiased review of the highest
scientific standards by qualified individuals
who have no interest in the outcome of the
review.
(e) Life-threatening Condition Defined.--In this section,
the term ``life-threatening condition'' means any disease or
condition from which the likelihood of death is probable unless
the course of the disease or condition is interrupted.
(f) Construction.--Nothing in this section shall be
construed to limit a plan's or issuer's coverage with respect
to clinical trials.
(g) Application to FEHBP.--Notwithstanding any provision of
chapter 89 of title 5, United States Code, this section shall
apply to health plans offered under the program under such
chapter.
(h) Preemption.--Notwithstanding any other provision of
this Act, nothing in this section shall preempt State laws that
require a clinical trials policy for State regulated health
insurance plans that is in addition to the policy required
under this section.
SEC. 2709. [300GG-9] DISCLOSURE OF INFORMATION.
(a) Disclosure of Information by Health Plan Issuers.--In
connection with the offering of any health insurance coverage
to a small employer or an individual, a health insurance
issuer--
(1) shall make a reasonable disclosure to such
employer,, \1\ or individual, as applicable, as part of
its solicitation and sales materials, of the
availability of information described in subsection
(b), and
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\1\ So in law.
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(2) upon request of such a employer, or individual,
as applicable,, \1\ or individual, as applicable,
provide such information.
(b) Information Described.--
(1) In general.--Subject to paragraph (3), with
respect to a health insurance issuer offering health
insurance coverage to a employer, or individual, as
applicable,, \1\ information described in this
subsection is information concerning--
(A) the provisions of such coverage
concerning issuer's right to change premium
rates and the factors that may affect changes
in premium rates; and
(B) the benefits and premiums available
under all health insurance coverage for which
the employer, or individual, as applicable, is
qualified.
(2) Form of information.--Information under this
subsection shall be provided to employers, or
individuals, as applicable, in a manner determined to
be understandable by the average employer, or
individual, as applicable,, \1\ and shall be sufficient
to reasonably inform employers, or individuals, as
applicable, of their rights and obligations under the
health insurance coverage.
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\1\ So in law.
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(3) Exception.--An issuer is not required under
this section to disclose any information that is
proprietary and trade secret information under
applicable law.
Subpart II--Improving Coverage
SEC. 2711. [300GG-11] NO LIFETIME OR ANNUAL LIMITS.
(a) Prohibition.--
(1) In general.--A group health plan and a health
insurance issuer offering group or individual health
insurance coverage may not establish--
(A) lifetime limits on the dollar value of
benefits for any participant or beneficiary; or
(B) except as provided in paragraph (2),
annual limits on the dollar value of benefits
for any participant or beneficiary.
(2) Annual limits prior to 2014.--With respect to
plan years beginning prior to January 1, 2014, a group
health plan and a health insurance issuer offering
group or individual health insurance coverage may only
establish a restricted annual limit on the dollar value
of benefits for any participant or beneficiary with
respect to the scope of benefits that are essential
health benefits under section 1302(b) of the Patient
Protection and Affordable Care Act, as determined by
the Secretary. In defining the term ``restricted annual
limit'' for purposes of the preceding sentence, the
Secretary shall ensure that access to needed services
is made available with a minimal impact on premiums.
(b) Per Beneficiary Limits.--Subsection (a) shall not be
construed to prevent a group health plan or health insurance
coverage from placing annual or lifetime per beneficiary limits
on specific covered benefits that are not essential health
benefits under section 1302(b) of the Patient Protection and
Affordable Care Act, to the extent that such limits are
otherwise permitted under Federal or State law.
SEC. 2712. [300GG-12] PROHIBITION ON RESCISSIONS.
A group health plan and a health insurance issuer offering
group or individual health insurance coverage shall not rescind
such plan or coverage with respect to an enrollee once the
enrollee is covered under such plan or coverage involved,
except that this section shall not apply to a covered
individual who has performed an act or practice that
constitutes fraud or makes an intentional misrepresentation of
material fact as prohibited by the terms of the plan or
coverage. Such plan or coverage may not be cancelled except
with prior notice to the enrollee, and only as permitted under
section 2702(c) or 2742(b).
SEC. 2713. [300GG-13] COVERAGE OF PREVENTIVE HEALTH SERVICES.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
shall, at a minimum provide coverage for and shall not impose
any cost sharing requirements for--
(1) evidence-based items or services that have in
effect a rating of ``A'' or ``B'' in the current
recommendations of the United States Preventive
Services Task Force;
(2) immunizations that have in effect a
recommendation from the Advisory Committee on
Immunization Practices of the Centers for Disease
Control and Prevention with respect to the individual
involved; and
(3) with respect to infants, children, and
adolescents, evidence-informed preventive care and
screenings provided for in the comprehensive guidelines
supported by the Health Resources and Services
Administration.
(4) with respect to women, such additional
preventive care and screenings not described in
paragraph (1) as provided for in comprehensive
guidelines supported by the Health Resources and
Services Administration for purposes of this paragraph.
(5) for the purposes of this Act, and for the
purposes of any other provision of law, the current
recommendations of the United States Preventive Service
Task Force regarding breast cancer screening,
mammography, and prevention shall be considered the
most current other than those issued in or around
November 2009.
Nothing in this subsection shall be construed to prohibit a
plan or issuer from providing coverage for services in addition
to those recommended by United States Preventive Services Task
Force or to deny coverage for services that are not recommended
by such Task Force.
(b) Interval.--
(1) In general.--The Secretary shall establish a
minimum interval between the date on which a
recommendation described in subsection (a)(1) or (a)(2)
or a guideline under subsection (a)(3) is issued and
the plan year with respect to which the requirement
described in subsection (a) is effective with respect
to the service described in such recommendation or
guideline.
(2) Minimum.--The interval described in paragraph
(1) shall not be less than 1 year.
(c) Value-based Insurance Design.--The Secretary may
develop guidelines to permit a group health plan and a health
insurance issuer offering group or individual health insurance
coverage to utilize value-based insurance designs.
SEC. 2714. [300GG-14] EXTENSION OF DEPENDENT COVERAGE.
(a) In General.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage
that provides dependent coverage of children shall continue to
make such coverage available for an adult child until the child
turns 26 years of age. Nothing in this section shall require a
health plan or a health insurance issuer described in the
preceding sentence to make coverage available for a child of a
child receiving dependent coverage.
(b) Regulations.--The Secretary shall promulgate
regulations to define the dependents to which coverage shall be
made available under subsection (a).
(c) Rule of Construction.--Nothing in this section shall be
construed to modify the definition of ``dependent'' as used in
the Internal Revenue Code of 1986 with respect to the tax
treatment of the cost of coverage.
SEC. 2715. [300GG-15] DEVELOPMENT AND UTILIZATION OF UNIFORM
EXPLANATION OF COVERAGE DOCUMENTS AND STANDARDIZED
DEFINITIONS.
(a) In General.--Not later than 12 months after the date of
enactment of the Patient Protection and Affordable Care Act,
the Secretary shall develop standards for use by a group health
plan and a health insurance issuer offering group or individual
health insurance coverage, in compiling and providing to
applicants, enrollees, and policyholders or certificate holders
a summary of benefits and coverage explanation that accurately
describes the benefits and coverage under the applicable plan
or coverage. In developing such standards, the Secretary shall
consult with the National Association of Insurance
Commissioners (referred to in this section as the ``NAIC''), a
working group composed of representatives of health insurance-
related consumer advocacy organizations, health insurance
issuers, health care professionals, patient advocates including
those representing individuals with limited English
proficiency, and other qualified individuals.
(b) Requirements.--The standards for the summary of
benefits and coverage developed under subsection (a) shall
provide for the following:
(1) Appearance.--The standards shall ensure that
the summary of benefits and coverage is presented in a
uniform format that does not exceed 4 pages in length
and does not include print smaller than 12-point font.
(2) Language.--The standards shall ensure that the
summary is presented in a culturally and linguistically
appropriate manner and utilizes terminology
understandable by the average plan enrollee.
(3) Contents.--The standards shall ensure that the
summary of benefits and coverage includes--
(A) uniform definitions of standard
insurance terms and medical terms (consistent
with subsection (g)) so that consumers may
compare health insurance coverage and
understand the terms of coverage (or exception
to such coverage);
(B) a description of the coverage,
including cost sharing for--
(i) each of the categories of the
essential health benefits described in
subparagraphs (A) through (J) of
section 1302(b)(1) of the Patient
Protection and Affordable Care Act; and
(ii) other benefits, as identified
by the Secretary;
(C) the exceptions, reductions, and
limitations on coverage;
(D) the cost-sharing provisions, including
deductible, coinsurance, and co-payment
obligations;
(E) the renewability and continuation of
coverage provisions;
(F) a coverage facts label that includes
examples to illustrate common benefits
scenarios, including pregnancy and serious or
chronic medical conditions and related cost
sharing, such scenarios to be based on
recognized clinical practice guidelines;
(G) a statement of whether the plan or
coverage--
(i) provides minimum essential
coverage (as defined under section
5000A(f) of the Internal Revenue Code
1986); and
(ii) ensures that the plan or
coverage share of the total allowed
costs of benefits provided under the
plan or coverage is not less than 60
percent of such costs;
(H) a statement that the outline is a
summary of the policy or certificate and that
the coverage document itself should be
consulted to determine the governing
contractual provisions; and
(I) a contact number for the consumer to
call with additional questions and an Internet
web address where a copy of the actual
individual coverage policy or group certificate
of coverage can be reviewed and obtained.
(c) Periodic Review and Updating.--The Secretary shall
periodically review and update, as appropriate, the standards
developed under this section.
(d) Requirement To Provide.--
(1) In general.--Not later than 24 months after the
date of enactment of the Patient Protection and
Affordable Care Act, each entity described in paragraph
(3) shall provide, prior to any enrollment restriction,
a summary of benefits and coverage explanation pursuant
to the standards developed by the Secretary under
subsection (a) to--
(A) an applicant at the time of
application;
(B) an enrollee prior to the time of
enrollment or reenrollment, as applicable; and
(C) a policyholder or certificate holder at
the time of issuance of the policy or delivery
of the certificate.
(2) Compliance.--An entity described in paragraph
(3) is deemed to be in compliance with this section if
the summary of benefits and coverage described in
subsection (a) is provided in paper or electronic form.
(3) Entities in general.--An entity described in
this paragraph is--
(A) a health insurance issuer (including a
group health plan that is not a self-insured
plan) offering health insurance coverage within
the United States; or
(B) in the case of a self-insured group
health plan, the plan sponsor or designated
administrator of the plan (as such terms are
defined in section 3(16) of the Employee
Retirement Income Security Act of 1974).
(4) Notice of modifications.--If a group health
plan or health insurance issuer makes any material
modification in any of the terms of the plan or
coverage involved (as defined for purposes of section
102 of the Employee Retirement Income Security Act of
1974) that is not reflected in the most recently
provided summary of benefits and coverage, the plan or
issuer shall provide notice of such modification to
enrollees not later than 60 days prior to the date on
which such modification will become effective.
(e) Preemption.--The standards developed under subsection
(a) shall preempt any related State standards that require a
summary of benefits and coverage that provides less information
to consumers than that required to be provided under this
section, as determined by the Secretary.
(f) Failure To Provide.--An entity described in subsection
(d)(3) that willfully fails to provide the information required
under this section shall be subject to a fine of not more than
$1,000 for each such failure. Such failure with respect to each
enrollee shall constitute a separate offense for purposes of
this subsection.
(g) Development of Standard Definitions.--
(1) In general.--The Secretary shall, by
regulation, provide for the development of standards
for the definitions of terms used in health insurance
coverage, including the insurance-related terms
described in paragraph (2) and the medical terms
described in paragraph (3).
(2) Insurance-related terms.--The insurance-related
terms described in this paragraph are premium,
deductible, co-insurance, co-payment, out-of-pocket
limit, preferred provider, non-preferred provider, out-
of-network co-payments, UCR (usual, customary and
reasonable) fees, excluded services, grievance and
appeals, and such other terms as the Secretary
determines are important to define so that consumers
may compare health insurance coverage and understand
the terms of their coverage.
(3) Medical terms.--The medical terms described in
this paragraph are hospitalization, hospital outpatient
care, emergency room care, physician services,
prescription drug coverage, durable medical equipment,
home health care, skilled nursing care, rehabilitation
services, hospice services, emergency medical
transportation, and such other terms as the Secretary
determines are important to define so that consumers
may compare the medical benefits offered by health
insurance and understand the extent of those medical
benefits (or exceptions to those benefits).
SEC. 2715A. [300GG-15A] PROVISION OF ADDITIONAL INFORMATION.
A group health plan and a health insurance issuer offering
group or individual health insurance coverage shall comply with
the provisions of section 1311(e)(3) of the Patient Protection
and Affordable Care Act, except that a plan or coverage that is
not offered through an Exchange shall only be required to
submit the information required to the Secretary and the State
insurance commissioner, and make such information available to
the public.
SEC. 2716. [300GG-16] PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY
COMPENSATED INDIVIDUALS.
(a) In General.--A group health plan (other than a self-
insured plan) shall satisfy the requirements of section
105(h)(2) of the Internal Revenue Code of 1986 (relating to
prohibition on discrimination in favor of highly compensated
individuals).
(b) Rules and Definitions.--For purposes of this section--
(1) Certain rules to apply.--Rules similar to the
rules contained in paragraphs (3), (4), and (8) of
section 105(h) of such Code shall apply.
(2) Highly compensated individual.--The term
``highly compensated individual'' has the meaning given
such term by section 105(h)(5) of such Code.
SEC. 2717. [300GG-17] ENSURING THE QUALITY OF CARE.
(a) Quality Reporting.--
(1) In general.--Not later than 2 years after the
date of enactment of the Patient Protection and
Affordable Care Act, the Secretary, in consultation
with experts in health care quality and stakeholders,
shall develop reporting requirements for use by a group
health plan, and a health insurance issuer offering
group or individual health insurance coverage, with
respect to plan or coverage benefits and health care
provider reimbursement structures that--
(A) improve health outcomes through the
implementation of activities such as quality
reporting, effective case management, care
coordination, chronic disease management, and
medication and care compliance initiatives,
including through the use of the medical homes
model as defined for purposes of section 3602
of the Patient Protection and Affordable Care
Act, for treatment or services under the plan
or coverage;
(B) implement activities to prevent
hospital readmissions through a comprehensive
program for hospital discharge that includes
patient-centered education and counseling,
comprehensive discharge planning, and post
discharge reinforcement by an appropriate
health care professional;
(C) implement activities to improve patient
safety and reduce medical errors through the
appropriate use of best clinical practices,
evidence based medicine, and health information
technology under the plan or coverage; and
(D) implement wellness and health promotion
activities.
(2) Reporting requirements.--
(A) In general.--A group health plan and a
health insurance issuer offering group or
individual health insurance coverage shall
annually submit to the Secretary, and to
enrollees under the plan or coverage, a report
on whether the benefits under the plan or
coverage satisfy the elements described in
subparagraphs (A) through (D) of paragraph (1).
(B) Timing of reports.--A report under
subparagraph (A) shall be made available to an
enrollee under the plan or coverage during each
open enrollment period.
(C) Availability of reports.--The Secretary
shall make reports submitted under subparagraph
(A) available to the public through an Internet
website.
(D) Penalties.--In developing the reporting
requirements under paragraph (1), the Secretary
may develop and impose appropriate penalties
for non-compliance with such requirements.
(E) Exceptions.--In developing the
reporting requirements under paragraph (1), the
Secretary may provide for exceptions to such
requirements for group health plans and health
insurance issuers that substantially meet the
goals of this section.
(b) Wellness and Prevention Programs.--For purposes of
subsection (a)(1)(D), wellness and health promotion activities
may include personalized wellness and prevention services,
which are coordinated, maintained or delivered by a health care
provider, a wellness and prevention plan manager, or a health,
wellness or prevention services organization that conducts
health risk assessments or offers ongoing face-to-face,
telephonic or web-based intervention efforts for each of the
program's participants, and which may include the following
wellness and prevention efforts:
(1) Smoking cessation.
(2) Weight management.
(3) Stress management.
(4) Physical fitness.
(5) Nutrition.
(6) Heart disease prevention.
(7) Healthy lifestyle support.
(8) Diabetes prevention.
(c) Protection of Second Amendment Gun Rights.--
(1) Wellness and prevention programs.--A wellness
and health promotion activity implemented under
subsection (a)(1)(D) may not require the disclosure or
collection of any information relating to--
(A) the presence or storage of a lawfully-
possessed firearm or ammunition in the
residence or on the property of an individual;
or
(B) the lawful use, possession, or storage
of a firearm or ammunition by an individual.
(2) Limitation on data collection.--None of the
authorities provided to the Secretary under the Patient
Protection and Affordable Care Act or an amendment made
by that Act shall be construed to authorize or may be
used for the collection of any information relating
to--
(A) the lawful ownership or possession of a
firearm or ammunition;
(B) the lawful use of a firearm or
ammunition; or
(C) the lawful storage of a firearm or
ammunition.
(3) Limitation on databases or data banks.--None of
the authorities provided to the Secretary under the
Patient Protection and Affordable Care Act or an
amendment made by that Act shall be construed to
authorize or may be used to maintain records of
individual ownership or possession of a firearm or
ammunition.
(4) Limitation on determination of premium rates or
eligibility for health insurance.--A premium rate may
not be increased, health insurance coverage may not be
denied, and a discount, rebate, or reward offered for
participation in a wellness program may not be reduced
or withheld under any health benefit plan issued
pursuant to or in accordance with the Patient
Protection and Affordable Care Act or an amendment made
by that Act on the basis of, or on reliance upon--
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use or storage of a firearm
or ammunition.
(5) Limitation on data collection requirements for
individuals.--No individual shall be required to
disclose any information under any data collection
activity authorized under the Patient Protection and
Affordable Care Act or an amendment made by that Act
relating to--
(A) the lawful ownership or possession of a
firearm or ammunition; or
(B) the lawful use, possession, or storage
of a firearm or ammunition.
(d) Regulations.--Not later than 2 years after the date of
enactment of the Patient Protection and Affordable Care Act,
the Secretary shall promulgate regulations that provide
criteria for determining whether a reimbursement structure is
described in subsection (a).
(e) Study and Report.--Not later than 180 days after the
date on which regulations are promulgated under subsection (c),
the Government Accountability Office shall review such
regulations and conduct a study and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report regarding the impact the activities
under this section have had on the quality and cost of health
care.
SEC. 2718. [300GG-18] BRINGING DOWN THE COST OF HEALTH CARE COVERAGE.
(a) Clear Accounting for Costs.--A health insurance issuer
offering group or individual health insurance coverage
(including a grandfathered health plan) shall, with respect to
each plan year, submit to the Secretary a report concerning the
ratio of the incurred loss (or incurred claims) plus the loss
adjustment expense (or change in contract reserves) to earned
premiums. Such report shall include the percentage of total
premium revenue, after accounting for collections or receipts
for risk adjustment and risk corridors and payments of
reinsurance, that such coverage expends--
(1) on reimbursement for clinical services provided
to enrollees under such coverage;
(2) for activities that improve health care
quality; and
(3) on all other non-claims costs, including an
explanation of the nature of such costs, and excluding
Federal and State taxes and licensing or regulatory
fees.
The Secretary shall make reports received under this section
available to the public on the Internet website of the
Department of Health and Human Services.
(b) Ensuring That Consumers Receive Value for Their Premium
Payments.--
(1) Requirement to provide value for premium
payments.--
(A) Requirement.--Beginning not later than
January 1, 2011, a health insurance issuer
offering group or individual health insurance
coverage (including a grandfathered health
plan) shall, with respect to each plan year,
provide an annual rebate to each enrollee under
such coverage, on a pro rata basis, if the
ratio of the amount of premium revenue expended
by the issuer on costs described in paragraphs
(1) and (2) of subsection (a) to the total
amount of premium revenue (excluding Federal
and State taxes and licensing or regulatory
fees and after accounting for payments or
receipts for risk adjustment, risk corridors,
and reinsurance under sections 1341, 1342, and
1343 of the Patient Protection and Affordable
Care Act) for the plan year (except as provided
in subparagraph (B)(ii)), is less than--
(i) with respect to a health
insurance issuer offering coverage in
the large group market, 85 percent, or
such higher percentage as a State may
by regulation determine; or
(ii) with respect to a health
insurance issuer offering coverage in
the small group market or in the
individual market, 80 percent, or such
higher percentage as a State may by
regulation determine, except that the
Secretary may adjust such percentage
with respect to a State if the
Secretary determines that the
application of such 80 percent may
destabilize the individual market in
such State.
(B) Rebate amount.--
(i) Calculation of amount.--The
total amount of an annual rebate
required under this paragraph shall be
in an amount equal to the product of--
(I) the amount by which the
percentage described in clause
(i) or (ii) of subparagraph (A)
exceeds the ratio described in
such subparagraph; and
(II) the total amount of
premium revenue (excluding
Federal and State taxes and
licensing or regulatory fees
and after accounting for
payments or receipts for risk
adjustment, risk corridors, and
reinsurance under sections
1341, 1342, and 1343 of the
Patient Protection and
Affordable Care Act) for such
plan year.
(ii) Calculation based on average
ratio.--Beginning on January 1, 2014,
the determination made under
subparagraph (A) for the year involved
shall be based on the averages of the
premiums expended on the costs
described in such subparagraph and
total premium revenue for each of the
previous 3 years for the plan.
(2) Consideration in setting percentages.--In
determining the percentages under paragraph (1), a
State shall seek to ensure adequate participation by
health insurance issuers, competition in the health
insurance market in the State, and value for consumers
so that premiums are used for clinical services and
quality improvements.
(3) Enforcement.--The Secretary shall promulgate
regulations for enforcing the provisions of this
section and may provide for appropriate penalties.
(c) Definitions.--Not later than December 31, 2010, and
subject to the certification of the Secretary, the National
Association of Insurance Commissioners shall establish uniform
definitions of the activities reported under subsection (a) and
standardized methodologies for calculating measures of such
activities, including definitions of which activities, and in
what regard such activities, constitute activities described in
subsection (a)(2). Such methodologies shall be designed to take
into account the special circumstances of smaller plans,
different types of plans, and newer plans.
(d) Adjustments.--The Secretary may adjust the rates
described in subsection (b) if the Secretary determines
appropriate on account of the volatility of the individual
market due to the establishment of State Exchanges.
(e) Standard Hospital Charges.--Each hospital operating
within the United States shall for each year establish (and
update) and make public (in accordance with guidelines
developed by the Secretary) a list of the hospital's standard
charges for items and services provided by the hospital,
including for diagnosis-related groups established under
section 1886(d)(4) of the Social Security Act.
SEC. 2719. [300GG-19] APPEALS PROCESS.
(a) Internal Claims Appeals.--
(1) In general.--A group health plan and a health
insurance issuer offering group or individual health
insurance coverage shall implement an effective appeals
process for appeals of coverage determinations and
claims, under which the plan or issuer shall, at a
minimum--
(A) have in effect an internal claims
appeal process;
(B) provide notice to enrollees, in a
culturally and linguistically appropriate
manner, of available internal and external
appeals processes, and the availability of any
applicable office of health insurance consumer
assistance or ombudsman established under
section 2793 to assist such enrollees with the
appeals processes; and
(C) allow an enrollee to review their file,
to present evidence and testimony as part of
the appeals process, and to receive continued
coverage pending the outcome of the appeals
process.
(2) Established processes.--To comply with
paragraph (1)--
(A) a group health plan and a health
insurance issuer offering group health coverage
shall provide an internal claims and appeals
process that initially incorporates the claims
and appeals procedures (including urgent
claims) set forth at section 2560.503-1 of
title 29, Code of Federal Regulations, as
published on November 21, 2000 (65 Fed. Reg.
70256), and shall update such process in
accordance with any standards established by
the Secretary of Labor for such plans and
issuers; and
(B) a health insurance issuer offering
individual health coverage, and any other
issuer not subject to subparagraph (A), shall
provide an internal claims and appeals process
that initially incorporates the claims and
appeals procedures set forth under applicable
law (as in existence on the date of enactment
of this section), and shall update such process
in accordance with any standards established by
the Secretary of Health and Human Services for
such issuers.
(b) External Review.--A group health plan and a health
insurance issuer offering group or individual health insurance
coverage--
(1) shall comply with the applicable State external
review process for such plans and issuers that, at a
minimum, includes the consumer protections set forth in
the Uniform External Review Model Act promulgated by
the National Association of Insurance Commissioners and
is binding on such plans; or
(2) shall implement an effective external review
process that meets minimum standards established by the
Secretary through guidance and that is similar to the
process described under paragraph (1)--
(A) if the applicable State has not
established an external review process that
meets the requirements of paragraph (1); or
(B) if the plan is a self-insured plan that
is not subject to State insurance regulation
(including a State law that establishes an
external review process described in paragraph
(1)).
(c) Secretary Authority.--The Secretary may deem the
external review process of a group health plan or health
insurance issuer, in operation as of the date of enactment of
this section, to be in compliance with the applicable process
established under subsection (b), as determined appropriate by
the Secretary.
SEC. 2719A. [300GG-19A] PATIENT PROTECTIONS.
(a) Choice of Health Care Professional.--If a group health
plan, or a health insurance issuer offering group or individual
health insurance coverage, requires or provides for designation
by a participant, beneficiary, or enrollee of a participating
primary care provider, then the plan or issuer shall permit
each participant, beneficiary, and enrollee to designate any
participating primary care provider who is available to accept
such individual.
(b) Coverage of Emergency Services.--
(1) In general.--If a group health plan, or a
health insurance issuer offering group or individual
health insurance issuer, provides or covers any
benefits with respect to services in an emergency
department of a hospital, the plan or issuer shall
cover emergency services (as defined in paragraph
(2)(B))--
(A) without the need for any prior
authorization determination;
(B) whether the health care provider
furnishing such services is a participating
provider with respect to such services;
(C) in a manner so that, if such services
are provided to a participant, beneficiary, or
enrollee--
(i) by a nonparticipating health
care provider with or without prior
authorization; or
(ii)(I) such services will be
provided without imposing any
requirement under the plan for prior
authorization of services or any
limitation on coverage where the
provider of services does not have a
contractual relationship with the plan
for the providing of services that is
more restrictive than the requirements
or limitations that apply to emergency
department services received from
providers who do have such a
contractual relationship with the plan;
and
(II) if such services are provided
out-of-network, the cost-sharing
requirement (expressed as a copayment
amount or coinsurance rate) is the same
requirement that would apply if such
services were provided in-network; \1\
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\1\ Probably should read ``; and''.
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(D) without regard to any other term or
condition of such coverage (other than
exclusion or coordination of benefits, or an
affiliation or waiting period, permitted under
section 2701 of this Act, section 701 of the
Employee Retirement Income Security Act of
1974, or section 9801 of the Internal Revenue
Code of 1986, and other than applicable cost-
sharing).
(2) Definitions.--In this subsection:
(A) Emergency medical condition.--The term
``emergency medical condition'' means a medical
condition manifesting itself by acute symptoms
of sufficient severity (including severe pain)
such that a prudent layperson, who possesses an
average knowledge of health and medicine, could
reasonably expect the absence of immediate
medical attention to result in a condition
described in clause (i), (ii), or (iii) of
section 1867(e)(1)(A) of the Social Security
Act.
(B) Emergency services.--The term
``emergency services'' means, with respect to
an emergency medical condition--
(i) a medical screening examination
(as required under section 1867 of the
Social Security Act) that is within the
capability of the emergency department
of a hospital, including ancillary
services routinely available to the
emergency department to evaluate such
emergency medical condition, and
(ii) within the capabilities of the
staff and facilities available at the
hospital, such further medical
examination and treatment as are
required under section 1867 of such Act
to stabilize the patient.
(C) Stabilize.--The term ``to stabilize'',
with respect to an emergency medical condition
(as defined in subparagraph (A)), has the
meaning give in section 1867(e)(3) of the
Social Security Act (42 U.S.C. 1395dd(e)(3)).
(c) Access to Pediatric Care.--
(1) Pediatric care.--In the case of a person who
has a child who is a participant, beneficiary, or
enrollee under a group health plan, or health insurance
coverage offered by a health insurance issuer in the
group or individual market, if the plan or issuer
requires or provides for the designation of a
participating primary care provider for the child, the
plan or issuer shall permit such person to designate a
physician (allopathic or osteopathic) who specializes
in pediatrics as the child's primary care provider if
such provider participates in the network of the plan
or issuer.
(2) Construction.--Nothing in paragraph (1) shall
be construed to waive any exclusions of coverage under
the terms and conditions of the plan or health
insurance coverage with respect to coverage of
pediatric care.
(d) Patient Access to Obstetrical and Gynecological Care.--
(1) General rights.--
(A) Direct access.--A group health plan, or
health insurance issuer offering group or
individual health insurance coverage, described
in paragraph (2) may not require authorization
or referral by the plan, issuer, or any person
(including a primary care provider described in
paragraph (2)(B)) in the case of a female
participant, beneficiary, or enrollee who seeks
coverage for obstetrical or gynecological care
provided by a participating health care
professional who specializes in obstetrics or
gynecology. Such professional shall agree to
otherwise adhere to such plan's or issuer's
policies and procedures, including procedures
regarding referrals and obtaining prior
authorization and providing services pursuant
to a treatment plan (if any) approved by the
plan or issuer.
(B) Obstetrical and gynecological care.--A
group health plan or health insurance issuer
described in paragraph (2) shall treat the
provision of obstetrical and gynecological
care, and the ordering of related obstetrical
and gynecological items and services, pursuant
to the direct access described under
subparagraph (A), by a participating health
care professional who specializes in obstetrics
or gynecology as the authorization of the
primary care provider.
(2) Application of paragraph.--A group health plan,
or health insurance issuer offering group or individual
health insurance coverage, described in this paragraph
is a group health plan or coverage that--
(A) provides coverage for obstetric or
gynecologic care; and
(B) requires the designation by a
participant, beneficiary, or enrollee of a
participating primary care provider.
(3) Construction.--Nothing in paragraph (1) shall
be construed to--
(A) waive any exclusions of coverage under
the terms and conditions of the plan or health
insurance coverage with respect to coverage of
obstetrical or gynecological care; or
(B) preclude the group health plan or
health insurance issuer involved from requiring
that the obstetrical or gynecological provider
notify the primary care health care
professional or the plan or issuer of treatment
decisions.
SEC. 2725. \1\ [300GG-25] STANDARDS RELATING TO BENEFITS FOR MOTHERS
AND NEWBORNS.
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\1\ The placement of this section and succeeding sections 2726,
2727, and 2728 here, versus after section 2724, is ambiguous insofar as
these sections at the time of their redesignation from sections 2702-
2708 were not explicitly moved to follow section 2724, yet the failure
to place them after section 2724 results in these sections not
following ordinary sequential numbering.
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(a) Requirements for Minimum Hospital Stay Following
Birth.--
(1) In general.--A group health plan, and a health
insurance issuer offering group or individual health
insurance coverage, may not--
(A) except as provided in paragraph (2)--
(i) restrict benefits for any
hospital length of stay in connection
with childbirth for the mother or
newborn child, following a normal
vaginal delivery, to less than 48
hours, or
(ii) restrict benefits for any
hospital length of stay in connection
with childbirth for the mother or
newborn child, following a cesarean
section, to less than 96 hours, or
(B) require that a provider obtain
authorization from the plan or the issuer for
prescribing any length of stay required under
subparagraph (A) (without regard to paragraph
(2)).
(2) Exception.--Paragraph (1)(A) shall not apply in
connection with any group health plan or health
insurance issuer in any case in which the decision to
discharge the mother or her newborn child prior to the
expiration of the minimum length of stay otherwise
required under paragraph (1)(A) is made by an attending
provider in consultation with the mother.
(b) Prohibitions.--A group health plan, and a health
insurance issuer offering group or individual health insurance
coverage, may not--
(1) deny to the mother or her newborn child
eligibility, or continued eligibility, to enroll or to
renew coverage under the terms of the plan or coverage,
solely for the purpose of avoiding the requirements of
this section;
(2) provide monetary payments or rebates to mothers
to encourage such mothers to accept less than the
minimum protections available under this section;
(3) penalize or otherwise reduce or limit the
reimbursement of an attending provider because such
provider provided care to an individual participant or
beneficiary in accordance with this section;
(4) provide incentives (monetary or otherwise) to
an attending provider to induce such provider to
provide care to an individual participant or
beneficiary in a manner inconsistent with this section;
or
(5) subject to subsection (c)(3), restrict benefits
for any portion of a period within a hospital length of
stay required under subsection (a) in a manner which is
less favorable than the benefits provided for any
preceding portion of such stay.
(c) Rules of Construction.--
(1) Nothing in this section shall be construed to
require a mother who is a participant or beneficiary--
(A) to give birth in a hospital; or
(B) to stay in the hospital for a fixed
period of time following the birth of her
child.
(2) This section shall not apply with respect to
any group health plan, or any health insurance issuer
offering group or individual health insurance coverage,
which does not provide benefits for hospital lengths of
stay in connection with childbirth for a mother or her
newborn child.
(3) Nothing in this section shall be construed as
preventing a group health plan or health insurance
issuer from imposing deductibles, coinsurance, or other
cost-sharing in relation to benefits for hospital
lengths of stay in connection with childbirth for a
mother or newborn child under the plan (or under health
insurance coverage offered in connection with a group
health plan), except that such coinsurance or other
cost-sharing for any portion of a period within a
hospital length of stay required under subsection (a)
may not be greater than such coinsurance or cost-
sharing for any preceding portion of such stay.
(d) Notice.--A group health plan under this part shall
comply with the notice requirement under section 711(d) of the
Employee Retirement Income Security Act of 1974 with respect to
the requirements of this section as if such section applied to
such plan.
(e) Level and Type of Reimbursements.--Nothing in this
section shall be construed to prevent a group health plan or a
health insurance issuer offering group or individual health
insurance coverage from negotiating the level and type of
reimbursement with a provider for care provided in accordance
with this section.
(f) Preemption; Exception for Health Insurance Coverage in
Certain States.--
(1) In general.--The requirements of this section
shall not apply with respect to health insurance
coverage if there is a State law (as defined in section
2723(d)(1)) for a State that regulates such coverage
that is described in any of the following
subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital
length of stay following a normal vaginal
delivery and at least a 96-hour hospital length
of stay following a cesarean section.
(B) Such State law requires such coverage
to provide for maternity and pediatric care in
accordance with guidelines established by the
American College of Obstetricians and
Gynecologists, the American Academy of
Pediatrics, or other established professional
medical associations.
(C) Such State law requires, in connection
with such coverage for maternity care, that the
hospital length of stay for such care is left
to the decision of (or required to be made by)
the attending provider in consultation with the
mother.
(2) Construction.--Section 2723(a)(1) shall not be
construed as superseding a State law described in
paragraph (1).
SEC. 2726. [300GG-26] PARITY IN MENTAL HEALTH AND SUBSTANCE USE
DISORDER BENEFITS.
(a) In General.--
(1) Aggregate lifetime limits.--In the case of a
group health plan or a health insurance issuer offering
group or individual health insurance coverage that
provides both medical and surgical benefits and mental
health or substance use disorder benefits--
(A) No lifetime limit.--If the plan or
coverage does not include an aggregate lifetime
limit on substantially all medical and surgical
benefits, the plan or coverage may not impose
any aggregate lifetime limit on mental health
or substance use disorder benefits.
(B) Lifetime limit.--If the plan or
coverage includes an aggregate lifetime limit
on substantially all medical and surgical
benefits (in this paragraph referred to as the
``applicable lifetime limit''), the plan or
coverage shall either--
(i) apply the applicable lifetime
limit both to the medical and surgical
benefits to which it otherwise would
apply and to mental health and
substance use disorder benefits and not
distinguish in the application of such
limit between such medical and surgical
benefits and mental health and
substance use disorder benefits; or
(ii) not include any aggregate
lifetime limit on mental health or
substance use disorder benefits that is
less than the applicable lifetime
limit.
(C) Rule in case of different limits.--In
the case of a plan or coverage that is not
described in subparagraph (A) or (B) and that
includes no or different aggregate lifetime
limits on different categories of medical and
surgical benefits, the Secretary shall
establish rules under which subparagraph (B) is
applied to such plan or coverage with respect
to mental health and substance use disorder
benefits by substituting for the applicable
lifetime limit an average aggregate lifetime
limit that is computed taking into account the
weighted average of the aggregate lifetime
limits applicable to such categories.
(2) Annual limits.--In the case of a group health
plan or a health insurance issuer offering group or
individual health insurance coverage that provides both
medical and surgical benefits and mental health or
substance use disorder benefits--
(A) No annual limit.--If the plan or
coverage does not include an annual limit on
substantially all medical and surgical
benefits, the plan or coverage may not impose
any annual limit on mental health or substance
use disorder benefits.
(B) Annual limit.--If the plan or coverage
includes an annual limit on substantially all
medical and surgical benefits (in this
paragraph referred to as the ``applicable
annual limit''), the plan or coverage shall
either--
(i) apply the applicable annual
limit both to medical and surgical
benefits to which it otherwise would
apply and to mental health and
substance use disorder benefits and not
distinguish in the application of such
limit between such medical and surgical
benefits and mental health and
substance use disorder benefits; or
(ii) not include any annual limit
on mental health or substance use
disorder benefits that is less than the
applicable annual limit.
(C) Rule in case of different limits.--In
the case of a plan or coverage that is not
described in subparagraph (A) or (B) and that
includes no or different annual limits on
different categories of medical and surgical
benefits, the Secretary shall establish rules
under which subparagraph (B) is applied to such
plan or coverage with respect to mental health
and substance use disorder benefits by
substituting for the applicable annual limit an
average annual limit that is computed taking
into account the weighted average of the annual
limits applicable to such categories.
(3) Financial requirements and treatment
limitations.--
(A) In general.--In the case of a group
health plan or a health insurance issuer
offering group or individual health insurance
coverage that provides both medical and
surgical benefits and mental health or
substance use disorder benefits, such plan or
coverage shall ensure that--
(i) the financial requirements
applicable to such mental health or
substance use disorder benefits are no
more restrictive than the predominant
financial requirements applied to
substantially all medical and surgical
benefits covered by the plan (or
coverage), and there are no separate
cost sharing requirements that are
applicable only with respect to mental
health or substance use disorder
benefits; and
(ii) the treatment limitations
applicable to such mental health or
substance use disorder benefits are no
more restrictive than the predominant
treatment limitations applied to
substantially all medical and surgical
benefits covered by the plan (or
coverage) and there are no separate
treatment limitations that are
applicable only with respect to mental
health or substance use disorder
benefits.
(B) Definitions.--In this paragraph:
(i) Financial requirement.--The
term ``financial requirement'' includes
deductibles, copayments, coinsurance,
and out-of-pocket expenses, but
excludes an aggregate lifetime limit
and an annual limit subject to
paragraphs (1) and (2).
(ii) Predominant.--A financial
requirement or treatment limit is
considered to be predominant if it is
the most common or frequent of such
type of limit or requirement.
(iii) Treatment limitation.--The
term ``treatment limitation'' includes
limits on the frequency of treatment,
number of visits, days of coverage, or
other similar limits on the scope or
duration of treatment.
(4) Availability of plan information.--The criteria
for medical necessity determinations made under the
plan with respect to mental health or substance use
disorder benefits (or the health insurance coverage
offered in connection with the plan with respect to
such benefits) shall be made available by the plan
administrator (or the health insurance issuer offering
such coverage) in accordance with regulations to any
current or potential participant, beneficiary, or
contracting provider upon request. The reason for any
denial under the plan (or coverage) of reimbursement or
payment for services with respect to mental health or
substance use disorder benefits in the case of any
participant or beneficiary shall, on request or as
otherwise required, be made available by the plan
administrator (or the health insurance issuer offering
such coverage) to the participant or beneficiary in
accordance with regulations.
(5) Out-of-network providers.--In the case of a
plan or coverage that provides both medical and
surgical benefits and mental health or substance use
disorder benefits, if the plan or coverage provides
coverage for medical or surgical benefits provided by
out-of-network providers, the plan or coverage shall
provide coverage for mental health or substance use
disorder benefits provided by out-of-network providers
in a manner that is consistent with the requirements of
this section.
(b) Construction.--Nothing in this section shall be
construed--
(1) as requiring a group health plan or a health
insurance issuer offering group or individual health
insurance coverage to provide any mental health or
substance use disorder benefits; or
(2) in the case of a group health plan or a health
insurance issuer offering group or individual health
insurance coverage that provides mental health or
substance use disorder benefits, as affecting the terms
and conditions of the plan or coverage relating to such
benefits under the plan or coverage, except as provided
in subsection (a).
(c) Exemptions.--
(1) Small employer exemption.--This section shall
not apply to any group health plan and a health
insurance issuer offering group or individual health
insurance coverage for any plan year of a small
employer (as defined in section 2791(e)(4), except that
for purposes of this paragraph such term shall include
employers with 1 employee in the case of an employer
residing in a State that permits small groups to
include a single individual).
(2) Cost exemption.--
(A) In general.--With respect to a group
health plan or a health insurance issuer
offering group or individual health insurance
coverage, if the application of this section to
such plan (or coverage) results in an increase
for the plan year involved of the actual total
costs of coverage with respect to medical and
surgical benefits and mental health and
substance use disorder benefits under the plan
(as determined and certified under subparagraph
(C)) by an amount that exceeds the applicable
percentage described in subparagraph (B) of the
actual total plan costs, the provisions of this
section shall not apply to such plan (or
coverage) during the following plan year, and
such exemption shall apply to the plan (or
coverage) for 1 plan year. An employer may
elect to continue to apply mental health and
substance use disorder parity pursuant to this
section with respect to the group health plan
(or coverage) involved regardless of any
increase in total costs.
(B) Applicable percentage.--With respect to
a plan (or coverage), the applicable percentage
described in this subparagraph shall be--
(i) 2 percent in the case of the
first plan year in which this section
is applied; and
(ii) 1 percent in the case of each
subsequent plan year.
(C) Determinations by actuaries.--
Determinations as to increases in actual costs
under a plan (or coverage) for purposes of this
section shall be made and certified by a
qualified and licensed actuary who is a member
in good standing of the American Academy of
Actuaries. All such determinations shall be in
a written report prepared by the actuary. The
report, and all underlying documentation relied
upon by the actuary, shall be maintained by the
group health plan or health insurance issuer
for a period of 6 years following the
notification made under subparagraph (E).
(D) 6-month determinations.--If a group
health plan (or a health insurance issuer
offering coverage in connection with a group
health plan) \1\ seeks an exemption under this
paragraph, determinations under subparagraph
(A) shall be made after such plan (or coverage)
has complied with this section for the first 6
months of the plan year involved.
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\1\ In section 1563 (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by section
10107(b)(1)) of Public Law 111-148, Congress may have intended to
replace the parenthetical with a reference to both group and individual
health insurance. The Congression intent is unclear.
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(E) Notification.--
(i) In general.--A group health
plan (or a health insurance issuer
offering coverage in connection with a
group health plan) \1\ that, based upon
a certification described under
subparagraph (C), qualifies for an
exemption under this paragraph, and
elects to implement the exemption,
shall promptly notify the Secretary,
the appropriate State agencies, and
participants and beneficiaries in the
plan of such election.
(ii) Requirement.--A notification
to the Secretary under clause (i) shall
include--
(I) a description of the
number of covered lives under
the plan (or coverage) involved
at the time of the
notification, and as
applicable, at the time of any
prior election of the cost-
exemption under this paragraph
by such plan (or coverage);
(II) for both the plan year
upon which a cost exemption is
sought and the year prior, a
description of the actual total
costs of coverage with respect
to medical and surgical
benefits and mental health and
substance use disorder benefits
under the plan; and
(III) for both the plan
year upon which a cost
exemption is sought and the
year prior, the actual total
costs of coverage with respect
to mental health and substance
use disorder benefits under the
plan.
(iii) Confidentiality.--A
notification to the Secretary under
clause (i) shall be confidential. The
Secretary shall make available, upon
request and on not more than an annual
basis, an anonymous itemization of such
notifications, that includes--
(I) a breakdown of States
by the size and type of
employers submitting such
notification; and
(II) a summary of the data
received under clause (ii).
(F) Audits by appropriate agencies.--To
determine compliance with this paragraph, the
Secretary may audit the books and records of a
group health plan or health insurance issuer
relating to an exemption, including any
actuarial reports prepared pursuant to
subparagraph (C), during the 6 year period
following the notification of such exemption
under subparagraph (E). A State agency
receiving a notification under subparagraph (E)
may also conduct such an audit with respect to
an exemption covered by such notification.
(d) Separate Application to Each Option Offered.--In the
case of a group health plan that offers a participant or
beneficiary two or more benefit package options under the plan,
the requirements of this section shall be applied separately
with respect to each such option.
(e) Definitions.--For purposes of this section--
(1) Aggregate lifetime limit.--The term ``aggregate
lifetime limit'' means, with respect to benefits under
a group health plan or health insurance coverage, a
dollar limitation on the total amount that may be paid
with respect to such benefits under the plan or health
insurance coverage with respect to an individual or
other coverage unit.
(2) Annual limit.--The term ``annual limit'' means,
with respect to benefits under a group health plan or
health
insurance coverage, a dollar limitation on the total
amount of benefits that may be paid with respect to
such benefits in a 12-month period under the plan or
health insurance coverage with respect to an individual
or other coverage unit.
(3) Medical or surgical benefits.--The term
``medical or surgical benefits'' means benefits with
respect to
medical or surgical services, as defined under the
terms of the plan or coverage (as the case may be), but
does not include mental health or substance use
disorder benefits.
(4) Mental health benefits.--The term ``mental
health benefits'' means benefits with respect to
services for mental health conditions, as defined under
the terms of the plan and in accordance with applicable
Federal and State law.
(5) Substance use disorder benefits.--The term
``substance use disorder benefits'' means benefits with
respect to services for substance use disorders, as
defined under the terms of the plan and in accordance
with applicable Federal and State law.
SEC. 2727. [300GG-27] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY
FOLLOWING MASTECTOMIES. \1\
The provisions of section 713 of the Employee Retirement
Income Security Act of 1974 shall apply to group health plans,
and and \2\ health insurance issuers offering group or
individual health insurance coverage, as if included in this
subpart.
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\1\ Section 2706 (prior to its redesignation as 2727 by Public Law
111-148) was added by subsection (a) of section 903 of the Departments
of Labor, Health and Human Services, and Education, and Related
Agencies Appropriations Act, 1999 (as contained in section 101(f) of
division A of Public Law 105-277; 112 Stat. 2681-438). Subsection (c)
of such section 903 concerns effective dates, and paragraph (1) of the
subsection provides as follows:
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``(1) Group plans.--
``(A) In general.--The amendment made by subsection
(a) shall apply to group health plans for plan years
beginning on or after the date of enactment of this
Act.
``(B) Special rule for collective bargaining
agreements.--In the case of a group health plan
maintained pursuant to 1 or more collective bargaining
agreements between employee representatives and 1 or
more employers, any plan amendment made pursuant to a
collective bargaining agreement relating to the plan
which amends the plan solely to conform to any
requirement added by the amendment made by subsection
(a) shall not be treated as a termination of such
collective bargaining agreement.''.
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The Public Law was enacted October 21, 1998.
\2\ So in law.
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SEC. 2728. [300GG-28] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY
NECESSARY LEAVE OF ABSENCE.
(a) Medically Necessary Leave of Absence.--In this section,
the term ``medically necessary leave of absence'' means, with
respect to a dependent child described in subsection (b)(2) in
connection with a group health plan or individual health
insurance coverage, a leave of absence of such child from a
postsecondary educational institution (including an institution
of higher education as defined in section 102 of the Higher
Education Act of 1965), or any other change in enrollment of
such child at such an institution, that--
(1) commences while such child is suffering from a
serious illness or injury;
(2) is medically necessary; and
(3) causes such child to lose student status for
purposes of coverage under the terms of the plan or
coverage.
(b) Requirement To Continue Coverage.--
(1) In general.--In the case of a dependent child
described in paragraph (2), a group health plan, or a
health insurance issuer that offers group or individual
health insurance coverage, shall not terminate coverage
of such child under such plan or health insurance
coverage due to a medically necessary leave of absence
before the date that is the earlier of--
(A) the date that is 1 year after the first
day of the medically necessary leave of
absence; or
(B) the date on which such coverage would
otherwise terminate under the terms of the plan
or health insurance coverage.
(2) Dependent child described.--A dependent child
described in this paragraph is, with respect to a group
health plan or individual health insurance coverage, a
beneficiary under the plan who--
(A) is a dependent child, under the terms
of the plan or coverage, of a participant or
beneficiary under the plan or coverage; and
(B) was enrolled in the plan or coverage,
on the basis of being a student at a
postsecondary educational institution (as
described in subsection (a)), immediately
before the first day of the medically necessary
leave of absence involved.
(3) Certification by physician.--Paragraph (1)
shall apply to a group health plan or individual health
insurance coverage only if the plan or issuer of the
coverage has received written certification by a
treating physician of the dependent child which states
that the child is suffering from a serious illness or
injury and that the leave of absence (or other change
of enrollment) described in subsection (a) is medically
necessary.
(c) Notice.--A group health plan, and a health insurance
issuer that offers group or individual health insurance
coverage, shall include, with any notice regarding a
requirement for certification of student status for coverage
under the plan or coverage, a description of the terms of this
section for continued coverage during medically necessary
leaves of absence. Such description shall be in language which
is understandable to the typical plan participant.
(d) No Change in Benefits.--A dependent child whose
benefits are continued under this section shall be entitled to
the same benefits as if (during the medically necessary leave
of absence) the child continued to be a covered student at the
institution of higher education and was not on a medically
necessary leave of absence.
(e) Continued Application in Case of Changed Coverage.--
If--
(1) a dependent child of a participant or
beneficiary is in a period of coverage under a group
health plan or individual health insurance coverage,
pursuant to a medically necessary leave of absence of
the child described in subsection (b);
(2) the manner in which the participant or
beneficiary is covered under the plan changes, whether
through a change in health insurance coverage or health
insurance issuer, a change between health insurance
coverage and self-insured coverage, or otherwise; and
(3) the coverage as so changed continues to provide
coverage of beneficiaries as dependent children,
this section shall apply to coverage of the child under the
changed coverage for the remainder of the period of the
medically necessary leave of absence of the dependent child
under the plan in the same manner as it would have applied if
the changed coverage had been the previous coverage.
Subpart 2--Exclusion of Plans; Enforcement; Preemption
SEC. 2722. \1\ [300GG-21] EXCLUSION OF CERTAIN PLANS.
---------------------------------------------------------------------------
\1\ The numerical sequence of section enumerators beginning in
subpart 2 so in law. See section enumerators at the end of subpart 1 of
this part and amendments redesignating section enumerators in subpart 2
by section 1001(4) and section 1563(c)(12) of Public Law 111-148. See
footnote accompanying section 2725 regarding ambiguity in placement of
sections 2725-2728.
There are conflicting amendments made to provisions of this
section by section 1563(a) and section 1563(c)(12)(B) (relating to
conforming amendments--originally designated as section 1562 and
redesignated as section 1563 by section 10107(b)(1)) of Public Law 111-
148. The amendments reflected here are from section 1563(a) of such
Public Law and thereby render the global amendment made by subsection
(c)(12)(B) unexecutable.
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(a) Limitation on Application of Provisions Relating to
Group Health Plans.--
(1) In general.--The requirements of subparts 1 and
2 \2\ shall apply with respect to group health plans
only--
---------------------------------------------------------------------------
\2\ The references to ``subparts 1 and 2'' probably should read
``subparts I and II''.
---------------------------------------------------------------------------
(A) subject to paragraph (2), in the case
of a plan that is a nonfederal governmental
plan, and
(B) with respect to health insurance
coverage offered in connection with a group
health plan (including such a plan that is a
church plan or a governmental plan).
(2) Treatment of nonfederal governmental plans.--
(A) Election to be excluded.--Except as
provided in subparagraph (D) or (E), if the
plan sponsor of a nonfederal governmental plan
which is a group health plan to which the
provisions of subparts 1 and 2 \3\ otherwise
apply makes an election under this subparagraph
(in such form and manner as the Secretary may
by regulations prescribe), then the
requirements of such subparts insofar as they
apply directly to group health plans (and not
merely to group health insurance coverage)
shall not apply to such governmental plans for
such period except as provided in this
paragraph.
(B) Period of election.--An election under
subparagraph (A) shall apply--
(i) for a single specified plan
year, or
(ii) in the case of a plan provided
pursuant to a collective bargaining
agreement, for the term of such
agreement.
An election under clause (i) may be extended
through subsequent elections under this
paragraph.
(C) Notice to enrollees.--Under such an
election, the plan shall provide for--
(i) notice to enrollees (on an
annual basis and at the time of
enrollment under the plan) of the fact
and consequences of such election, and
(ii) certification and disclosure
of creditable coverage under the plan
with respect to enrollees in accordance
with section 2701(e).
(D) Election not applicable to requirements
concerning genetic information.--The election
described in subparagraph (A) shall not be
available with respect to the provisions of
subsections (a)(1)(F), (b)(3), (c), and (d) of
section 2702 and the provisions of sections
2701 and 2702(b) to the extent that such
provisions apply to genetic information.
(E) Election not applicable.--The election
described in subparagraph (A) shall not be
available with respect to the provisions of
subparts I and II.
(b) Exception for Certain Benefits.--The requirements of
subparts 1 and 2 \1\ shall not apply to any individual coverage
or any group health plan (or group health insurance coverage)
in relation to its provision of excepted benefits described in
section 2791(c)(1).
---------------------------------------------------------------------------
\1\ The references to ``subparts 1 and 2'' probably should read
``subparts I and II''.
---------------------------------------------------------------------------
(c) Exception for Certain Benefits If Certain Conditions
Met.--
(1) Limited, excepted benefits.--The requirements
of subparts 1 and 2 \1\ shall not apply to any
individual coverage or any group health plan (and group
health insurance coverage offered in connection with a
group health plan) in relation to its provision of
excepted benefits described in section 2791(c)(2) if
the benefits--
(A) are provided under a separate policy,
certificate, or contract of insurance; or
(B) are otherwise not an integral part of
the plan.
(2) Noncoordinated, excepted benefits.--The
requirements of subparts 1 and 2 \1\ shall not apply to
any individual coverage or any group health plan (and
group health insurance coverage offered in connection
with a group health plan) in relation to its provision
of excepted benefits described in section 2791(c)(3) if
all of the following conditions are met:
(A) The benefits are provided under a
separate policy, certificate, or contract of
insurance.
(B) There is no coordination between the
provision of such benefits and any exclusion of
benefits under any group health plan maintained
by the same plan sponsor.
(C) Such benefits are paid with respect to
an event without regard to whether benefits are
provided with respect to such an event under
any group health plan maintained by the same
plan sponsor or, with respect to individual
coverage, under any health insurance coverage
maintained by the same health insurance issuer
\2\.
---------------------------------------------------------------------------
\2\ Section 1563 (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by section
10107(b)(1)) of Public Law 111-148 provides for an amendment to insert
``or, with respect to individual coverage, under any health insurance
coverage maintained by the same health insurance issuer''. Such
amendment did not specify where to insert this new language, however,
it was carried out by inserting this new language before the period at
the end in order to reflect the probable intent of Congress.
---------------------------------------------------------------------------
(3) Supplemental excepted benefits.--The
requirements of this part shall not apply to any
individual coverage or any group health plan (and group
health insurance coverage) in relation to its provision
of excepted benefits described in section 27971(c)(4)
if the benefits are provided under a separate policy,
certificate, or contract of insurance.
(d) Treatment of Partnerships.--For purposes of this part--
(1) Treatment as a group health plan.--Any plan,
fund, or program which would not be (but for this
subsection) an employee welfare benefit plan and which
is established or maintained by a partnership, to the
extent that such plan, fund, or program provides
medical care (including items and services paid for as
medical care) to present or former partners in the
partnership or to their dependents (as defined under
the terms of the plan, fund, or program), directly or
through insurance, reimbursement, or otherwise, shall
be treated (subject to paragraph (2)) as an employee
welfare benefit plan which is a group health plan.
(2) Employer.--In the case of a group health plan,
the term ``employer'' also includes the partnership in
relation to any partner.
(3) Participants of group health plans.--In the
case of a group health plan, the term ``participant''
also includes--
(A) in connection with a group health plan
maintained by a partnership, an individual who
is a partner in relation to the partnership, or
(B) in connection with a group health plan
maintained by a self-employed individual (under
which one or more employees are participants),
the self-employed individual,
if such individual is, or may become, eligible to
receive a benefit under the plan or such individual's
beneficiaries may be eligible to receive any such
benefit.
SEC. 2723. [300GG-22] ENFORCEMENT.
(a) State Enforcement.--
(1) State authority.--Subject to section 2723, each
State may require that health insurance issuers that
issue, sell, renew, or offer health insurance coverage
in the State in the individual or group market meet the
requirements of this part with respect to such issuers.
(2) Failure to implement provisions.--In the case
of a determination by the Secretary that a State has
failed to substantially enforce a provision (or
provisions) in this part with respect to health
insurance issuers in the State, the Secretary shall
enforce such provision (or provisions) under subsection
(b) insofar as they relate to the issuance, sale,
renewal, and offering of health insurance coverage in
connection with group health plans or individual health
insurance coverage in such State.
(b) Secretarial Enforcement Authority.--
(1) Limitation.--The provisions of this subsection
shall apply to enforcement of a provision (or
provisions) of this part only--
(A) as provided under subsection (a)(2);
and
(B) with respect to individual health
insurance coverage or group health plans that
are non-Federal governmental plans.
(2) Imposition of penalties.--In the cases
described in paragraph (1)--
(A) In general.--Subject to the succeeding
provisions of this subsection, any non-Federal
governmental plan that is a group health plan
and any health insurance issuer that fails to
meet a provision of this part applicable to
such plan or issuer is subject to a civil money
penalty under this subsection.
(B) Liability for penalty.--In the case of
a
failure by--
(i) a health insurance issuer, the
issuer is liable for such penalty, or
(ii) a group health plan that is a
non-Federal governmental plan which
is--
(I) sponsored by 2 or more
employers, the plan is liable
for such penalty, or
(II) not so sponsored, the
employer is liable for such
penalty.
(C) Amount of penalty.--
(i) In general.--The maximum amount
of penalty imposed under this paragraph
is $100 for each day for each
individual with respect to which such a
failure occurs.
(ii) Considerations in
imposition.--In determining the amount
of any penalty to be assessed under
this paragraph, the Secretary shall
take into account the previous record
of compliance of the entity being
assessed with the applicable provisions
of this part and the gravity of the
violation.
(iii) Limitations.--
(I) Penalty not to apply
where failure not discovered
exercising reasonable
diligence.--No civil money
penalty shall be imposed under
this paragraph on any failure
during any period for which it
is established to the
satisfaction of the Secretary
that none of the entities
against whom the penalty would
be imposed knew, or exercising
reasonable diligence would have
known, that such failure
existed.
(II) Penalty not to apply
to failures corrected within 30
days.--No civil money penalty
shall be imposed under this
paragraph on any failure if
such failure was due to
reasonable cause and not to
willful neglect, and such
failure is corrected during the
30-day period beginning on the
first day any of the entities
against whom the penalty would
be imposed knew, or exercising
reasonable diligence would have
known, that such failure
existed.
(D) Administrative review.--
(i) Opportunity for hearing.--The
entity assessed shall be afforded an
opportunity for hearing by the
Secretary upon request made within 30
days after the date of the issuance of
a notice of assessment. In such hearing
the decision shall be made on the
record pursuant to section 554 of title
5, United States Code. If no hearing is
requested, the assessment shall
constitute a final and unappealable
order.
(ii) Hearing procedure.--If a
hearing is requested, the initial
agency decision shall be made by an
administrative law judge, and such
decision shall become the final order
unless the Secretary modifies or
vacates the decision. Notice of intent
to modify or vacate the decision of the
administrative law judge shall be
issued to the parties within 30 days
after the date of the decision of the
judge. A final order which takes effect
under this paragraph shall be
subject to review only as provided
under subparagraph (E).
(E) Judicial review.--
(i) Filing of action for review.--
Any entity against whom an order
imposing a civil money penalty has been
entered after an agency hearing under
this paragraph may obtain review by the
United States district court for any
district in which such entity is
located or the United States District
Court for the District of Columbia by
filing a notice of appeal in such court
within 30 days from the date of such
order, and simultaneously sending a
copy of such notice by registered mail
to the Secretary.
(ii) Certification of
administrative record.--The Secretary
shall promptly certify and file in such
court the record upon which the penalty
was imposed.
(iii) Standard for review.--The
findings of the Secretary shall be set
aside only if found to be unsupported
by substantial evidence as provided by
section 706(2)(E) of title 5, United
States Code.
(iv) Appeal.--Any final decision,
order, or judgment of the district
court concerning such review shall be
subject to appeal as provided in
chapter 83 of title 28 of such Code.
(F) Failure to pay assessment; maintenance
of action.--
(i) Failure to pay assessment.--If
any entity fails to pay an assessment
after it has become a final and
unappealable order, or after the court
has entered final judgment in favor of
the Secretary, the Secretary shall
refer the matter to the Attorney
General who shall recover the amount
assessed by action in the appropriate
United States district court.
(ii) Nonreviewability.--In such
action the validity and appropriateness
of the final order imposing the penalty
shall not be subject to review.
(G) Payment of penalties.--Except as
otherwise provided, penalties collected under
this paragraph shall be paid to the Secretary
(or other officer) imposing the penalty and
shall be available without appropriation and
until expended for the purpose of enforcing the
provisions with respect to which the penalty
was imposed.
(3) Enforcement authority relating to genetic
discrimination.--
(A) General rule.--In the cases described
in paragraph (1), notwithstanding the
provisions of paragraph (2)(C), the succeeding
subparagraphs of this paragraph shall apply
with respect to an action under this subsection
by the Secretary with respect to any failure of
a health insurance issuer in connection with a
group health plan, to meet the requirements of
subsection (a)(1)(F), (b)(3), (c), or (d) of
section 2702 or section 2701 or 2702(b)(1) with
respect to genetic information in connection
with the plan.
(B) Amount.--
(i) In general.--The amount of the
penalty imposed under this paragraph
shall be $100 for each day in the
noncompliance period with respect to
each participant or beneficiary to whom
such failure relates.
(ii) Noncompliance period.--For
purposes of this paragraph, the term
``noncompliance period'' means, with
respect to any failure, the period--
(I) beginning on the date
such failure first occurs; and
(II) ending on the date the
failure is corrected.
(C) Minimum penalties where failure
discovered.--Notwithstanding clauses (i) and
(ii) of subparagraph (D):
(i) In general.--In the case of 1
or more failures with respect to an
individual--
(I) which are not corrected
before the date on which the
plan receives a notice from the
Secretary of such violation;
and
(II) which occurred or
continued during the period
involved;
the amount of penalty imposed by
subparagraph (A) by reason of such
failures with respect to such
individual shall not be less than
$2,500.
(ii) Higher minimum penalty where
violations are more than de minimis.--
To the extent violations for which any
person is liable under this paragraph
for any year are more than de minimis,
clause (i) shall be applied by
substituting ``$15,000'' for ``$2,500''
with respect to such person.
(D) Limitations.--
(i) Penalty not to apply where
failure not discovered exercising
reasonable diligence.--No penalty shall
be imposed by subparagraph (A) on any
failure during any period for which it
is established to the satisfaction of
the Secretary that the person otherwise
liable for such penalty did not know,
and exercising reasonable diligence
would not have known, that such failure
existed.
(ii) Penalty not to apply to
failures corrected within certain
periods.--No penalty shall be imposed
by subparagraph (A) on any failure if--
(I) such failure was due to
reasonable cause and not to
willful neglect; and
(II) such failure is
corrected during the 30-day
period beginning on the first
date the person otherwise
liable for such penalty knew,
or exercising reasonable
diligence would have known,
that such failure existed.
(iii) Overall limitation for
unintentional failures.--In the case of
failures which are due to reasonable
cause and not to willful neglect, the
penalty imposed by subparagraph (A) for
failures shall not exceed the amount
equal to the lesser of--
(I) 10 percent of the
aggregate amount paid or
incurred by the employer (or
predecessor employer) during
the preceding taxable year for
group health plans; or
(II) $500,000.
(E) Waiver by secretary.--In the case of a
failure which is due to reasonable cause and
not to willful neglect, the Secretary may waive
part or all of the penalty imposed by
subparagraph (A) to the extent that the payment
of such penalty would be excessive relative to
the failure involved.
SEC. 2724. [300GG-23] PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.
(a) Continued Applicability of State Law With Respect to
Health Insurance Issuers.--
(1) In General.--Subject to paragraph (2) and
except as provided in subsection (b), this part and
part C insofar as it relates to this part shall not be
construed to supersede any provision of State law which
establishes, implements, or continues in effect any
standard or requirement solely relating to health
insurance issuers in connection with individual or
group health insurance coverage except to the extent
that such standard or requirement prevents the
application of a requirement of this part.
(2) Continued preemption with respect to group
health plans.--Nothing in this part shall be construed
to affect or modify the provisions of section 514 of
the Employee Retirement Income Security Act of 1974
with respect to group health plans.
(b) Special Rules in Case of Portability Requirements.--
(1) In general.--Subject to paragraph (2), the
provisions of this part relating to health insurance
coverage offered by a health insurance issuer supersede
any provision of State law which establishes,
implements, or continues in effect a standard or
requirement applicable to imposition of a preexisting
condition exclusion specifically governed by section
701 which differs from the standards or requirements
specified in such section.
(2) Exceptions.--Only in relation to health
insurance coverage offered by a health insurance
issuer, the provisions of this part do not supersede
any provision of State law to the extent that such
provision--
(i) \1\ substitutes for the reference to
``6-month period'' in section 2701(a)(1) a
reference to any shorter period of time;
---------------------------------------------------------------------------
\1\ Clauses (i) through (vii) probably should be redesignated as
subparagraphs (A) through (G). See section 102(a) of Public Law 104-191
(110 Stat. 1971).
---------------------------------------------------------------------------
(ii) \1\ substitutes for the reference to
``12 months'' and ``18 months'' in section
2701(a)(2) a reference to any shorter period of
time;
(iii) \1\ substitutes for the references to
``63'' days in sections 2701(c)(2)(A) and
2701(d)(4)(A) a reference to any greater number
of days;
(iv) \1\ substitutes for the reference to
``30-day period'' in sections 2701(b)(2) and
2701(d)(1) a reference to any greater period;
(v) \1\ prohibits the imposition of any
preexisting condition exclusion in cases not
described in section 2701(d) or expands the
exceptions described in such section;
(vi) \1\ requires special enrollment
periods in addition to those required under
section 2701(f); or
(vii) \1\ reduces the maximum period
permitted in an affiliation period under
section 2701(g)(1)(B).
(c) Rules of Construction.--Nothing in this part (other
than section 2704) shall be construed as requiring a group
health plan or health insurance coverage to provide specific
benefits under the terms of such plan or coverage.
(d) Definitions.--For purposes of this section--
(1) State law.--The term ``State law'' includes all
laws, decisions, rules, regulations, or other State
action having the effect of law, of any State. A law of
the United States applicable only to the District of
Columbia shall be treated as a State law rather than a
law of the United States.
(2) State.--The term ``State'' includes a State
(including the Northern Mariana Islands), any political
subdivisions of a State or such Islands, or any agency
or instrumentality of either. \2\
---------------------------------------------------------------------------
\2\ See footnote accompanying section 2725 regarding ambiguity in
placement of sections 2725-2728.
=======================================================================
Part B--Individual Market Rules \1\
Subpart 1--Portability, Access, and Renewability Requirements
SEC. 2741. [300GG-41] GUARANTEED AVAILABILITY OF INDIVIDUAL HEALTH
INSURANCE COVERAGE TO CERTAIN INDIVIDUALS WITH
PRIOR GROUP COVERAGE.
(a) Guaranteed Availability.--
(1) In general.--Subject to the succeeding
subsections of this section and section 2744, each
health insurance issuer that offers health insurance
coverage (as defined in section 2791(b)(1)) in the
individual market in a State may not, with respect to
an eligible individual (as defined in subsection (b))
desiring to enroll in individual health insurance
coverage--
---------------------------------------------------------------------------
\1\ Section 111(b) of Public Law 104-191 (110 Stat. 1987) provides
as follows:
``(b) Effective Date.--
---------------------------------------------------------------------------
``(1) In general.--Except as provided in this subsection,
part B of title XXVII of the Public Health Service Act (as
inserted by subsection (a)) shall apply with respect to health
insurance coverage offered, sold, issued, renewed, in effect,
or operated in the individual market after June 30, 1997,
regardless of when a period of creditable coverage occurs.
``(2) Application of certification rules.--The provisions of
section 102(d)(2) of this Act shall apply to section 2743 of
the the Public Health Service Act in the same manner as it
applies to section 2701(e) [redesignated as section 2704(e) by
P.L. 111-148] of such Act.''.
---------------------------------------------------------------------------
With respect to paragraph (2) of such section 111(b), subsection
(d) of section 102 of Public Law 104-191 is not divided into paragraphs
(1) and (2) (and the subsection relates to a technical correction).
Subsection (c)(2) of such section 102 does relate to certifications.
---------------------------------------------------------------------------
(A) decline to offer such coverage to, or
deny enrollment of, such individual; or
(B) impose any preexisting condition
exclusion (as defined in section 2701(b)(1)(A))
with respect to such coverage.
(2) Substitution by state of acceptable alternative
mechanism.--The requirement of paragraph (1) shall not
apply to health insurance coverage offered in the
individual market in a State in which the State is
implementing an acceptable alternative mechanism under
section 2744.
(b) Eligible Individual Defined.--In this part, the term
``eligible individual'' means an individual--
(1)(A) for whom, as of the date on which the
individual seeks coverage under this section, the
aggregate of the periods of creditable coverage (as
defined in section 2701(c)) is 18 or more months and
(B) whose most recent prior creditable coverage was
under a group health plan, governmental plan, or church
plan (or health insurance coverage offered in
connection with any such plan);
(2) who is not eligible for coverage under (A) a
group health plan, (B) part A or part B of title XVIII
of the Social Security Act, or (C) a State plan under
title XIX of such Act (or any successor program), and
does not have other health insurance coverage;
(3) with respect to whom the most recent coverage
within the coverage period described in paragraph
(1)(A) was not terminated based on a factor described
in paragraph (1) or (2) of section 2712(b) (relating to
nonpayment of premiums or fraud);
(4) if the individual had been offered the option
of continuation coverage under a COBRA continuation
provision or under a similar State program, who elected
such coverage; and
(5) who, if the individual elected such
continuation coverage, has exhausted such continuation
coverage under such provision or program.
(c) Alternative Coverage Permitted Where No State
Mechanism.--
(1) In general.--In the case of health insurance
coverage offered in the individual market in a State in
which the State is not implementing an acceptable
alternative mechanism under section 2744, the health
insurance issuer may elect to limit the coverage
offered under subsection (a) so long as it offers at
least two different policy forms of health insurance
coverage both of which--
(A) are designed for, made generally
available to, and actively marketed to, and
enroll both eligible and other individuals by
the issuer; and
(B) meet the requirement of paragraph (2)
or (3), as elected by the issuer.
For purposes of this subsection, policy forms which
have different cost-sharing arrangements or different
riders shall be considered to be different policy
forms.
(2) Choice of most popular policy forms.--The
requirement of this paragraph is met, for health
insurance coverage policy forms offered by an issuer in
the individual market, if the issuer offers the policy
forms for individual health insurance coverage with the
largest, and next to largest, premium volume of all
such policy forms offered by the issuer in the State or
applicable marketing or service area (as may be
prescribed in regulation) by the issuer in the
individual market in the period involved.
(3) Choice of 2 policy forms with representative
coverage.--
(A) In general.--The requirement of this
paragraph is met, for health insurance coverage
policy forms offered by an issuer in the
individual market, if the issuer offers a
lower-level coverage policy form (as defined in
subparagraph (B)) and a higher-level coverage
policy form (as defined in subparagraph (C))
each of which includes benefits substantially
similar to other individual health insurance
coverage offered by the issuer in that State
and each of which is covered under a method
described in section 2744(c)(3)(A) (relating to
risk adjustment, risk spreading, or financial
subsidization).
(B) Lower-level of coverage described.--A
policy form is described in this subparagraph
if the actuarial value of the benefits under
the coverage is at least 85 percent but not
greater than 100 percent of a weighted average
(described in subparagraph (D)).
(C) Higher-level of coverage described.--A
policy form is described in this subparagraph
if--
(i) the actuarial value of the
benefits under the coverage is at least
15 percent greater than the actuarial
value of the coverage described in
subparagraph (B) offered by the issuer
in the area involved; and
(ii) the actuarial value of the
benefits under the coverage is at least
100 percent but not greater than 120
percent of a weighted average
(described in subparagraph (D)).
(D) Weighted average.--For purposes of this
paragraph, the weighted average described in
this subparagraph is the average actuarial
value of the benefits provided by all the
health insurance coverage issued (as elected by
the issuer) either by that issuer or by all
issuers in the State in the individual market
during the previous year (not including
coverage issued under this section), weighted
by enrollment for the different coverage.
(4) Election.--The issuer elections under this
subsection shall apply uniformly to all eligible
individuals in the State for that issuer. Such an
election shall be effective for policies offered during
a period of not shorter than 2 years.
(5) Assumptions.--For purposes of paragraph (3),
the actuarial value of benefits provided under
individual health insurance coverage shall be
calculated based on a standardized population and a set
of standardized utilization and cost factors.
(d) Special Rules for Network Plans.--
(1) In general.--In the case of a health insurance
issuer that offers health insurance coverage in the
individual market through a network plan, the issuer
may--
(A) limit the individuals who may be
enrolled under such coverage to those who live,
reside, or work within the service area for
such network plan; and
(B) within the service area of such plan,
deny such coverage to such individuals if the
issuer has demonstrated, if required, to the
applicable State authority that--
(i) it will not have the capacity
to deliver services adequately to
additional individual enrollees because
of its obligations to existing group
contract holders and enrollees and
individual enrollees, and
(ii) it is applying this paragraph
uniformly to individuals without regard
to any health status-related factor of
such individuals and without regard to
whether the individuals are eligible
individuals.
(2) 180-day suspension upon denial of coverage.--An
issuer, upon denying health insurance coverage in any
service area in accordance with paragraph (1)(B), may
not offer coverage in the individual market within such
service area for a period of 180 days after such
coverage is denied.
(e) Application of Financial Capacity Limits.--
(1) In general.--A health insurance issuer may deny
health insurance coverage in the individual market to
an eligible individual if the issuer has demonstrated,
if required, to the applicable State authority that--
(A) it does not have the financial reserves
necessary to underwrite additional coverage;
and
(B) it is applying this paragraph uniformly
to all individuals in the individual market in
the State consistent with applicable State law
and without regard to any health status-related
factor of such individuals and without regard
to whether the individuals are eligible
individuals.
(2) 180-day suspension upon denial of coverage.--An
issuer upon denying individual health insurance
coverage in any service area in accordance with
paragraph (1) may not offer such coverage in the
individual market within such service area for a period
of 180 days after the date such coverage is denied or
until the issuer has demonstrated, if required under
applicable State law, to the applicable State authority
that the issuer has sufficient financial reserves to
underwrite additional coverage, whichever is later. A
State may provide for the application of this paragraph
on a service-area-specific basis.
(e) \1\ Market Requirements.--
---------------------------------------------------------------------------
\1\ So in law. Probably should redesignate the second subsection
(e) and subsection (f) as subsections (f) and (g), respectively. See
section 111(a) of Pub. L. 104-191 (110 Stat. 1978).
---------------------------------------------------------------------------
(1) In general.--The provisions of subsection (a)
shall not be construed to require that a health
insurance issuer offering health insurance coverage
only in connection with group health plans or through
one or more bona fide associations, or both, offer such
health insurance coverage in the individual market.
(2) Conversion policies.--A health insurance issuer
offering health insurance coverage in connection with
group health plans under this title shall not be deemed
to be a health insurance issuer offering individual
health insurance coverage solely because such issuer
offers a conversion policy.
(f) \1\ Construction.--Nothing in this section shall be
construed--
(1) to restrict the amount of the premium rates
that an issuer may charge an individual for health
insurance coverage provided in the individual market
under applicable State law; or
(2) to prevent a health insurance issuer offering
health insurance coverage in the individual market from
establishing premium discounts or rebates or modifying
otherwise applicable copayments or deductibles in
return for adherence to programs of health promotion
and disease prevention.
SEC. 2742. [300GG-42] GUARANTEED RENEWABILITY OF INDIVIDUAL HEALTH
INSURANCE COVERAGE.
(a) In General.--Except as provided in this section, a
health insurance issuer that provides individual health
insurance coverage to an individual shall renew or continue in
force such coverage at the option of the individual.
(b) General Exceptions.--A health insurance issuer may
nonrenew or discontinue health insurance coverage of an
individual in the individual market based only on one or more
of the following:
(1) Nonpayment of premiums.--The individual has
failed to pay premiums or contributions in accordance
with the terms of the health insurance coverage or the
issuer has not received timely premium payments.
(2) Fraud.--The individual has performed an act or
practice that constitutes fraud or made an intentional
misrepresentation of material fact under the terms of
the coverage.
(3) Termination of plan.--The issuer is ceasing to
offer coverage in the individual market in accordance
with subsection (c) and applicable State law.
(4) Movement outside service area.--In the case of
a health insurance issuer that offers health insurance
coverage in the market through a network plan, the
individual no longer resides, lives, or works in the
service area (or in an area for which the issuer is
authorized to do business) but only if such coverage is
terminated under this paragraph uniformly without
regard to any health status-related factor of covered
individuals.
(5) Association membership ceases.--In the case of
health insurance coverage that is made available in the
individual market only through one or more bona fide
associations, the membership of the individual in the
association (on the basis of which the coverage is
provided) ceases but only if such coverage is
terminated under this paragraph uniformly without
regard to any health status-related factor of covered
individuals.
(c) Requirements for Uniform Termination of Coverage.--
(1) Particular type of coverage not offered.--In
any case in which an issuer decides to discontinue
offering a particular type of health insurance coverage
offered in the individual market, coverage of such type
may be discontinued by the issuer only if--
(A) the issuer provides notice to each
covered individual provided coverage of this
type in such market of such discontinuation at
least 90 days prior to the date of the
discontinuation of such coverage;
(B) the issuer offers to each individual in
the individual market provided coverage of this
type, the option to purchase any other
individual health insurance coverage currently
being offered by the issuer for individuals in
such market; and
(C) in exercising the option to discontinue
coverage of this type and in offering the
option of coverage under subparagraph (B), the
issuer acts uniformly without regard to any
health status-related factor of enrolled
individuals or individuals who may become
eligible for such coverage.
(2) Discontinuance of all coverage.--
(A) In general.--Subject to subparagraph
(C), in any case in which a health insurance
issuer elects to discontinue offering all
health insurance coverage in the individual
market in a State, health insurance coverage
may be discontinued by the issuer only if--
(i) the issuer provides notice to
the applicable State authority and to
each individual of such discontinuation
at least 180 days prior to the date of
the expiration of such coverage, and
(ii) all health insurance issued or
delivered for issuance in the State in
such market are discontinued and
coverage under such health insurance
coverage in such market is not renewed.
(B) Prohibition on market reentry.--In the
case of a discontinuation under subparagraph
(A) in the individual market, the issuer may
not provide for the issuance of any health
insurance coverage in the market and State
involved during the 5-year period beginning on
the date of the discontinuation of the last
health insurance coverage not so renewed.
(d) Exception for Uniform Modification of Coverage.--At the
time of coverage renewal, a health insurance issuer may modify
the health insurance coverage for a policy form offered to
individuals in the individual market so long as such
modification is consistent with State law and effective on a
uniform basis among all individuals with that policy form.
(e) Application to Coverage Offered Only Through
Associations.--In applying this section in the case of health
insurance coverage that is made available by a health insurance
issuer in the individual market to individuals only through one
or more associations, a reference to an ``individual'' is
deemed to include a reference to such an association (of which
the individual is a member).
SEC. 2743. [300GG-43] CERTIFICATION OF COVERAGE.
The provisions of section 2701(e) shall apply to health
insurance coverage offered by a health insurance issuer in the
individual market in the same manner as it applies to health
insurance coverage offered by a health insurance issuer in
connection with a group health plan in the small or large group
market.
SEC. 2744. [300GG-44] STATE FLEXIBILITY IN INDIVIDUAL MARKET REFORMS.
(a) Waiver of Requirements Where Implementation of
Acceptable Alternative Mechanism.--
(1) In general.--The requirements of section 2741
shall not apply with respect to health insurance
coverage offered in the individual market in the State
so long as a State is found to be implementing, in
accordance with this section and consistent with
section 2762(b), an alternative mechanism (in this
section referred to as an ``acceptable alternative
mechanism'')--
(A) under which all eligible individuals
are provided a choice of health insurance
coverage;
(B) under which such coverage does not
impose any preexisting condition exclusion with
respect to such coverage;
(C) under which such choice of coverage
includes at least one policy form of coverage
that is comparable to comprehensive health
insurance coverage offered in the individual
market in such State or that is comparable to a
standard option of coverage available under the
group or individual health insurance laws of
such State; and
(D) in a State which is implementing--
(i) a model act described in
subsection (c)(1),
(ii) a qualified high risk pool
described in subsection (c)(2), or
(iii) a mechanism described in
subsection (c)(3).
(2) Permissible Forms of mechanisms.--A private or
public individual health insurance mechanism (such as a
health insurance coverage pool or programs, mandatory
group conversion policies, guaranteed issue of one or
more plans of individual health insurance coverage, or
open enrollment by one or more health insurance
issuers), or combination of such mechanisms, that is
designed to provide access to health benefits for
individuals in the individual market in the State in
accordance with this section may constitute an
acceptable alternative mechanism.
(b) Application of Acceptable Alternative Mechanisms.--
(1) Presumption.--
(A) In general.--Subject to the succeeding
provisions of this subsection, a State is
presumed to be implementing an acceptable
alternative mechanism in accordance with this
section as of July 1, 1997, if, by not later
than April 1, 1997, the chief executive officer
of a State--
(i) notifies the Secretary that the
State has enacted or intends to enact
(by not later than January 1, 1998, or
July 1, 1998, in the case of a State
described in subparagraph (B)(ii)) any
necessary legislation to provide for
the implementation of a mechanism
reasonably designed to be an acceptable
alternative mechanism as of January 1,
1998, (or, in the case of a State
described in subparagraph (B)(ii), July
1, 1998); and
(ii) provides the Secretary with
such information as the Secretary may
require to review the mechanism and its
implementation (or proposed
implementation) under this subsection.
(B) Delay permitted for certain states.--
(i) Effect of delay.--In the case
of a State described in clause (ii)
that provides notice under subparagraph
(A)(i), for the presumption to continue
on and after July 1, 1998, the chief
executive officer of the State by April
1, 1998--
(I) must notify the
Secretary that the State has
enacted any necessary
legislation to provide for the
implementation of a mechanism
reasonably designed to be an
acceptable alternative
mechanism as of July 1, 1998;
and
(II) must provide the
Secretary with such information
as the Secretary may require to
review the mechanism and its
implementation (or proposed
implementation) under this
subsection.
(ii) States described.--A State
described in this clause is a State
that has a legislature that does not
meet within the 12-month period
beginning on the date of enactment of
this Act.
(C) Continued application.--In order for a
mechanism to continue to be presumed to be an
acceptable alternative mechanism, the State
shall provide the Secretary every 3 years with
information described in subparagraph (A)(ii)
or (B)(i)(II) (as the case may be).
(2) Notice.--If the Secretary finds, after review
of information provided under paragraph (1) and in
consultation with the chief executive officer of the
State and the insurance commissioner or chief insurance
regulatory official of the State, that such a mechanism
is not an acceptable alternative mechanism or is not
(or no longer) being implemented, the Secretary--
(A) shall notify the State of--
(i) such preliminary determination,
and
(ii) the consequences under
paragraph (3) of a failure to implement
such a mechanism; and
(B) shall permit the State a reasonable
opportunity in which to modify the mechanism
(or to adopt another mechanism) in a manner so
that may be an acceptable alternative mechanism
or to provide for implementation of such a
mechanism.
(3) Final determination.--If, after providing
notice and opportunity under paragraph (2), the
Secretary finds that the mechanism is not an acceptable
alternative mechanism or the State is not implementing
such a mechanism, the Secretary shall notify the State
that the State is no longer considered to be
implementing an acceptable alternative mechanism and
that the requirements of section 2741 shall apply to
health insurance coverage offered in the individual
market in the State, effective as of a date specified
in the notice.
(4) Limitation on secretarial authority.--The
Secretary shall not make a determination under
paragraph (2) or (3) on any basis other than the basis
that a mechanism is not an acceptable alternative
mechanism or is not being implemented.
(5) Future adoption of mechanisms.--If a State,
after January 1, 1997, submits the notice and
information described in paragraph (1), unless the
Secretary makes a finding described in paragraph (3)
within the 90-day period beginning on the date of
submission of the notice and information, the mechanism
shall be considered to be an acceptable alternative
mechanism for purposes of this section, effective 90
days after the end of such period, subject to the
second sentence of paragraph (1).
(c) Provision Related to Risk.--
(1) Adoption of naic models.--The model act
referred to in subsection (a)(1)(D)(i) is the Small
Employer and Individual Health Insurance Availability
Model Act (adopted by the National Association of
Insurance Commissioners on June 3, 1996) insofar as it
applies to individual health insurance coverage or the
Individual Health Insurance Portability Model Act (also
adopted by such Association on such date).
(2) Qualified high risk pool.--For purposes of
subsection (a)(1)(D)(ii), a ``qualified high risk
pool'' described in this paragraph is a high risk pool
that--
(A) provides to all eligible individuals
health insurance coverage (or comparable
coverage) that does not impose any preexisting
condition exclusion with respect to such
coverage for all eligible individuals, and
(B) provides for premium rates and covered
benefits for such coverage consistent with
standards included in the NAIC Model Health
Plan for Uninsurable Individuals Act (as in
effect as of the date of the enactment of this
title).
(3) Other mechanisms.--For purposes of subsection
(a)(1)(D)(iii), a mechanism described in this
paragraph--
(A) provides for risk adjustment, risk
spreading, or a risk spreading mechanism (among
issuers or policies of an issuer) or otherwise
provides for some financial subsidization for
eligible individuals, including through
assistance to participating issuers; or
(B) is a mechanism under which each
eligible individual is provided a choice of all
individual health insurance coverage otherwise
available.
SEC. 2745. [300GG-45] RELIEF FOR HIGH RISK POOLS.
(a) Seed Grants to States.--The Secretary shall provide
from the funds appropriated under subsection (d)(1)(A) a grant
of up to $1,000,000 to each State that has not created a
qualified high risk pool as of the date of enactment of the
State High Risk Pool Funding Extension Act of 2006 for the
State's costs of creation and initial operation of such a pool.
(b) Grants for Operational Losses.--
(1) In general.--In the case of a State that has
established a qualified high risk pool that--
(A) restricts premiums charged under the
pool to no more than 200 percent of the premium
for applicable standard risk rates;
(B) offers a choice of two or more coverage
options through the pool; and
(C) has in effect a mechanism reasonably
designed to ensure continued funding of losses
incurred by the State in connection with
operation of the pool after the end of the last
fiscal year for which a grant is provided under
this paragraph;
the Secretary shall provide, from the funds
appropriated under paragraphs (1)(B)(i) and (2)(A) of
subsection (d) and allotted to the State under
paragraph (2), a grant for the losses incurred by the
State in connection with the operation of the pool.
(2) Allotment.--Subject to paragraph (4), the
amounts appropriated under paragraphs (1)(B)(i) and
(2)(A) of subsection (d) for a fiscal year shall be
allotted and made available to the States (or the
entities that operate the high risk pool under
applicable State law) that qualify for a grant under
paragraph (1) as follows:
(A) An amount equal to 40 percent of such
appropriated amount for the fiscal year shall
be allotted in equal amounts to each qualifying
State that is one of the 50 States or the
District of Columbia and that applies for a
grant under this subsection.
(B) An amount equal to 30 percent of such
appropriated amount for the fiscal year shall
be allotted among qualifying States that apply
for such a grant so that the amount allotted to
such a State bears the same ratio to such
appropriated amount as the number of uninsured
individuals in the State bears to the total
number of uninsured individuals (as determined
by the Secretary) in all qualifying States that
so apply.
(C) An amount equal to 30 percent of such
appropriated amount for the fiscal year shall
be allotted among qualifying States that apply
for such a grant so that the amount allotted to
a State bears the same ratio to such
appropriated amount as the number of
individuals enrolled in health care coverage
through the qualified high risk pool of the
State bears to the total number of individuals
so enrolled through qualified high risk pools
(as determined by the Secretary) in all
qualifying States that so apply.
(3) Special rule for pools charging higher
premiums.--In the case of a qualified high risk pool of
a State which charges premiums that exceed 150 percent
of the premium for applicable standard risks, the State
shall use at least 50 percent of the amount of the
grant provided to the State to carry out this
subsection to reduce premiums for enrollees.
(4) Limitation for territories.--In no case shall
the aggregate amount allotted and made available under
paragraph (2) for a fiscal year to States that are not
the 50 States or the District of Columbia exceed
$1,000,000.
(c) Bonus Grants for Supplemental Consumer Benefits.--
(1) In general.--In the case of a State that is one
of the 50 States or the District of Columbia, that has
established a qualified high risk pool, and that is
receiving a grant under subsection (b)(1), the
Secretary shall provide, from the funds appropriated
under paragraphs (1)(B)(ii) and (2)(B) of subsection
(d) and allotted to the State under paragraph (3), a
grant to be used to provide supplemental consumer
benefits to enrollees or potential enrollees (or
defined subsets of such enrollees or potential
enrollees) in qualified high risk pools.
(2) Benefits.--A State shall use amounts received
under a grant under this subsection to provide one or
more of the following benefits:
(A) Low-income premium subsidies.
(B) A reduction in premium trends, actual
premiums, or other cost-sharing requirements.
(C) An expansion or broadening of the pool
of individuals eligible for coverage, such as
through eliminating waiting lists, increasing
enrollment caps, or providing flexibility in
enrollment rules.
(D) Less stringent rules, or additional
waiver authority, with respect to coverage of
pre-existing conditions.
(E) Increased benefits.
(F) The establishment of disease management
programs.
(3) Allotment; limitation.--The Secretary shall
allot funds appropriated under paragraphs (1)(B)(ii)
and (2)(B) of subsection (d) among States qualifying
for a grant under paragraph (1) in a manner specified
by the Secretary, but in no case shall the amount so
allotted to a State for a fiscal year exceed 10 percent
of the funds so appropriated for the fiscal year.
(4) Rule of construction.--Nothing in this
subsection shall be construed to prohibit a State that,
on the date of the enactment of the State High Risk
Pool Funding Extension Act of 2006, is in the process
of implementing a program to provide benefits of the
type described in paragraph (2), from being eligible
for a grant under this subsection.
(d) Funding.--
(1) Appropriation for fiscal year 2006.--There are
authorized to be appropriated for fiscal year 2006--
(A) $15,000,000 to carry out subsection
(a); and
(B) $75,000,000, of which, subject to
paragraph (4)--
(i) two-thirds of the amount
appropriated shall be made available
for allotments under subsection (b)(2);
and
(ii) one-third of the amount
appropriated shall be made available
for allotments under subsection (c)(3).
(2) Authorization of appropriations for fiscal
years 2007 through 2010.--There are authorized to be
appropriated $75,000,000 for each of fiscal years 2007
through 2010, of which, subject to paragraph (4)--
(A) two-thirds of the amount appropriated
for a fiscal year shall be made available for
allotments under subsection (b)(2); and
(B) one-third of the amount appropriated
for a fiscal year shall be made available for
allotments under subsection (c)(3).
(3) Availability.--Funds appropriated for purposes
of carrying out this section for a fiscal year shall
remain available for obligation through the end of the
following fiscal year.
(4) Reallotment.--If, on June 30 of each fiscal
year for which funds are appropriated under paragraph
(1)(B) or (2), the Secretary determines that all the
amounts so appropriated are not allotted or otherwise
made available to States, such remaining amounts shall
be allotted and made available under subsection (b)
among States receiving grants under subsection (b) for
the fiscal year based upon the allotment formula
specified in such subsection.
(5) No entitlement.--Nothing in this section shall
be construed as providing a State with an entitlement
to a grant under this section.
(e) Applications.--To be eligible for a grant under this
section, a State shall submit to the Secretary an application
at such time, in such manner, and containing such information
as the Secretary may require.
(f) Annual Report.--The Secretary shall submit to Congress
an annual report on grants provided under this section. Each
such report shall include information on the distribution of
such grants among States and the use of grant funds by States.
(g) Definitions.--In this section:
(1) Qualified high risk pool.--
(A) In general.--The term ``qualified high
risk pool'' has the meaning given such term in
section 2744(c)(2), except that a State may
elect to meet the requirement of subparagraph
(A) of such section (insofar as it requires the
provision of coverage to all eligible
individuals) through providing for the
enrollment of eligible individuals through an
acceptable alternative mechanism (as defined
for purposes of section 2744) that includes a
high risk pool as a component.
(2) Standard risk rate.--The term ``standard risk
rate'' means a rate--
(A) determined under the State high risk
pool by considering the premium rates charged
by other health insurers offering health
insurance coverage to individuals in the
insurance market served;
(B) that is established using reasonable
actuarial techniques; and
(C) that reflects anticipated claims
experience and expenses for the coverage
involved.
(3) State.--The term ``State'' means any of the 50
States and the District of Columbia and includes Puerto
Rico, the Virgin Islands, Guam, American Samoa, and the
Northern Mariana Islands.
Subpart 2--Other Requirements
SEC. 2751. [300GG-51] STANDARDS RELATING TO BENEFITS FOR MOTHERS AND
NEWBORNS.
(a) In General.--The provisions of section 2704 (other than
subsections (d) and (f)) shall apply to health insurance
coverage offered by a health insurance issuer in the individual
market in the same manner as it applies to health insurance
coverage offered by a health insurance issuer in connection
with a group health plan in the small or large group market.
(b) Notice Requirement.--A health insurance issuer under
this part shall comply with the notice requirement under
section 711(d) of the Employee Retirement Income Security Act
of 1974 with respect to the requirements referred to in
subsection (a) as if such section applied to such issuer and
such issuer were a group health plan.
(c) Preemption; Exception for Health Insurance
Coverage in Certain States.--
(1) In general.--The requirements of this section
shall not apply with respect to health insurance
coverage if there is a State law (as defined in section
2723(d)(1)) for a State that regulates such coverage
that is described in any of the following
subparagraphs:
(A) Such State law requires such coverage
to provide for at least a 48-hour hospital
length of stay following a normal vaginal
delivery and at least a 96-hour hospital length
of stay following a cesarean section.
(B) Such State law requires such coverage
to provide for maternity and pediatric care in
accordance with guidelines established by the
American College of Obstetricians and
Gynecologists, the American Academy of
Pediatrics, or other established professional
medical associations.
(C) Such State law requires, in connection
with such coverage for maternity care, that the
hospital length of stay for such care is left
to the decision of (or required to be made by)
the attending provider in consultation with the
mother.
(2) Construction.--Section 2762(a) shall not be
construed as superseding a State law described in
paragraph (1).
SEC. 2752. [300GG-52] REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY
FOLLOWING MASTECTOMIES. \1\
The provisions of section 2706 shall apply to health
insurance coverage offered by a health insurance issuer in the
individual market in the same manner as they apply to health
insurance coverage offered by a health insurance issuer in
connection with a group health plan in the small or large group
market.
---------------------------------------------------------------------------
\1\ Section 2752 was added by subsection (b) of section 903 of the
Departments of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1999 (as contained in section
101(f) of division A of Public Law 105-277 (112 Stat. 2681-438)).
Subsection (c) of such section 903 concerns effective dates, and
paragraph (2) of the subsection provides as follows:
---------------------------------------------------------------------------
``(2) Individual plans.--The amendment made by subsection (b)
shall apply with respect to health insurance coverage offered,
sold, issued, renewed, in effect, or operated in the individual
market on or after the date of enactment of this Act.''.
---------------------------------------------------------------------------
The Public Law was enacted October 21, 1998.
---------------------------------------------------------------------------
SEC. 2753. \2\ [300GG-53] PROHIBITION OF HEALTH DISCRIMINATION ON THE
BASIS OF GENETIC INFORMATION.
---------------------------------------------------------------------------
\2\ Another section designated as section 2753 appears at the end
of part B. There are details in a footnote regarding its placement at
the end.
---------------------------------------------------------------------------
(a) Prohibition on Genetic Information as a Condition of
Eligibility.--
(1) In general.--A health insurance issuer offering
health insurance coverage in the individual market may
not establish rules for the eligibility (including
continued eligibility) of any individual to enroll in
individual health insurance coverage based on genetic
information.
(2) Rule of construction.--Nothing in paragraph (1)
or in paragraphs (1) and (2) of subsection (e) shall be
construed to preclude a health insurance issuer from
establishing rules for eligibility for an individual to
enroll in individual health insurance coverage based on
the manifestation of a disease or disorder in that
individual, or in a family member of such individual
where such family member is covered under the policy
that covers such individual.
(b) Prohibition on Genetic Information in Setting Premium
Rates.--
(1) In general.--A health insurance issuer offering
health insurance coverage in the individual market
shall not adjust premium or contribution amounts for an
individual on the basis of genetic information
concerning the individual or a family member of the
individual.
(2) Rule of construction.--Nothing in paragraph (1)
or in paragraphs (1) and (2) of subsection (e) shall be
construed to preclude a health insurance issuer from
adjusting premium or contribution amounts for an
individual on the basis of a manifestation of a disease
or disorder in that individual, or in a family member
of such individual where such family member is covered
under the policy that covers such individual. In such
case, the manifestation of a disease or disorder in one
individual cannot also be used as genetic information
about other individuals covered under the policy issued
to such individual and to further increase premiums or
contribution amounts.
(c) Prohibition on Genetic Information as Preexisting
Condition.--
(1) In general.--A health insurance issuer offering
health insurance coverage in the individual market may
not, on the basis of genetic information, impose any
preexisting condition exclusion (as defined in section
2701(b)(1)(A)) with respect to such coverage.
(2) Rule of construction.--Nothing in paragraph (1)
or in paragraphs (1) and (2) of subsection (e) shall be
construed to preclude a health insurance issuer from
imposing any preexisting condition exclusion for an
individual with respect to health insurance coverage on
the basis of a manifestation of a disease or disorder
in that individual.
(d) Genetic Testing.--
(1) Limitation on requesting or requiring genetic
testing.--A health insurance issuer offering health
insurance coverage in the individual market shall not
request or require an individual or a family member of
such individual to undergo a genetic test.
(2) Rule of construction.--Paragraph (1) shall not
be construed to limit the authority of a health care
professional who is providing health care services to
an individual to request that such individual undergo a
genetic test.
(3) Rule of construction regarding payment.--
(A) In general.--Nothing in paragraph (1)
shall be construed to preclude a health
insurance issuer offering health insurance
coverage in the individual market from
obtaining and using the results of a genetic
test in making a determination regarding
payment (as such term is defined for the
purposes of applying the regulations
promulgated by the Secretary under part C of
title XI of the Social Security Act and section
264 of the Health Insurance Portability and
Accountability Act of 1996, as may be revised
from time to time) consistent with subsection
(a) and (c).
(B) Limitation.--For purposes of
subparagraph (A), a health insurance issuer
offering health insurance coverage in the
individual market may request only the minimum
amount of information necessary to accomplish
the intended purpose.
(4) Research exception.--Notwithstanding paragraph
(1), a health insurance issuer offering health
insurance coverage in the individual market may
request, but not require, that an individual or a
family member of such individual undergo a genetic test
if each of the following conditions is met:
(A) The request is made pursuant to
research that complies with part 46 of title
45, Code of Federal Regulations, or equivalent
Federal regulations, and any applicable State
or local law or regulations for the protection
of human subjects in research.
(B) The issuer clearly indicates to each
individual, or in the case of a minor child, to
the legal guardian of such child, to whom the
request is made that--
(i) compliance with the request is
voluntary; and
(ii) non-compliance will have no
effect on enrollment status or premium
or contribution amounts.
(C) No genetic information collected or
acquired under this paragraph shall be used for
underwriting purposes.
(D) The issuer notifies the Secretary in
writing that the issuer is conducting
activities pursuant to the exception provided
for under this paragraph, including a
description of the activities conducted.
(E) The issuer complies with such other
conditions as the Secretary may by regulation
require for activities conducted under this
paragraph.
(e) Prohibition on Collection of Genetic Information.--
(1) In general.--A health insurance issuer offering
health insurance coverage in the individual market
shall not request, require, or purchase genetic
information for underwriting purposes (as defined in
section 2791).
(2) Prohibition on collection of genetic
information prior to enrollment.--A health insurance
issuer offering health insurance coverage in the
individual market shall not request, require, or
purchase genetic information with respect to any
individual prior to such individual's enrollment under
the plan in connection with such enrollment.
(3) Incidental collection.--If a health insurance
issuer offering health insurance coverage in the
individual market obtains genetic information
incidental to the requesting, requiring, or purchasing
of other information concerning any individual, such
request, requirement, or purchase shall not be
considered a violation of paragraph (2) if such
request, requirement, or purchase is not in violation
of paragraph (1).
(f) Genetic Information of a Fetus or Embryo.--Any
reference in this part to genetic information concerning an
individual or family member of an individual shall--
(1) with respect to such an individual or family
member of an individual who is a pregnant woman,
include genetic information of any fetus carried by
such pregnant woman; and
(2) with respect to an individual or family member
utilizing an assisted reproductive technology, include
genetic information of any embryo legally held by the
individual or family member.
Subpart 3--General Provisions \1\
SEC. 2761. [300GG-61] ENFORCEMENT.
(a) State Enforcement.--
(1) State authority.--Subject to section 2762, each
State may require that health insurance issuers that
issue, sell, renew, or offer health insurance coverage
in the State in the individual market meet the
requirements established under this part with respect
to such issuers.
---------------------------------------------------------------------------
\1\ Section 605(a)(3) of Public Law 104-204 (110 Stat. 2941) adds
this subpart designation and heading to part B.
---------------------------------------------------------------------------
(2) Failure to implement requirements.--In the case
of a State that fails to substantially enforce the
requirements set forth in this part with respect to
health insurance issuers in the State, the Secretary
shall enforce the requirements of this part under
subsection (b) insofar as they relate to the issuance,
sale, renewal, and offering of health insurance
coverage in the individual market in such State.
(b) Secretarial Enforcement Authority.--The Secretary shall
have the same authority in relation to enforcement of the
provisions of this part with respect to issuers of health
insurance coverage in the individual market in a State as the
Secretary has under section 2722(b)(2), and section 2722(b)(3)
with respect to violations of genetic nondiscrimination
provisions, in relation to the enforcement of the provisions of
part A with respect to issuers of health insurance coverage in
the small group market in the State.
SEC. 2762. [300GG-62] PREEMPTION. \1\
---------------------------------------------------------------------------
\1\ Section 1563(c)(15)(A) (relating to conforming amendments--
originally designated as section 1562 and redesignated as section 1563
by section 10107(b)(1)) of Public Law 111-148 provides for an amendment
in the section heading by inserting ``AND APPLICATION'' before the
period. Section 1563(c)(15)(B) (as so redesignated) of such Public Law
provides for an amendment to add at the end a new subsection (c). See
note set out in italic typeface that appears after subsection (b)
below.
The amendments to section 2762 made by section 1563(c)(15), as so
redesignated, takes effect on date of enactment of Public Law 111-148
(March 23, 2010); however, they're being treated here as if they take
effect on January 1, 2014 to reflect the probable intent of Congress
and in order to be consistent with the execution of different
amendments made by such section 1563 to part A of this title (see
details regarding the effective date in a note to a second version of
part A).
---------------------------------------------------------------------------
(a) In General.--Subject to subsection (b), nothing in this
part (or part C insofar as it applies to this part) shall be
construed to prevent a State from establishing, implementing,
or continuing in effect standards and requirements unless such
standards and requirements prevent the application of a
requirement of this part.
(b) Rules of Construction.--(1) Nothing in this part (or
part C insofar as it applies to this part) shall be construed
to affect or modify the provisions of section 514 of the
Employee Retirement Income Security Act of 1974 (29 U.S.C.
1144).
(2) Nothing in this part (other than section 2751) shall be
construed as requiring health insurance coverage offered in the
individual market to provide specific benefits under the terms
of such coverage.
======================================================================
[Note: Section 1563(c)(15)(B) (relating to conforming
amendments--originally designated as section 1562 and
redesignated as section 1563 by section 10107(b)(1)) of Public
Law 111-148 provides for an amendment to add a new subsection
(c) at the end of section 2762. Such amendment takes effect on
date of enactment of Public Law 111-148 (March 23, 2010);
however, they're being treated here as if they take effect on
January 1, 2014 to reflect the probable intent of Congress and
in order to be consistent with the execution of different
amendments made by such section 1563 to part A of this title
(see details regarding the effective date in a note to a second
version of part A). Upon such date, the following new
subsection (c) reads as follows :]
(c) Application of Part A Provisions.--
(1) In general.--The provisions of part A shall
apply to health insurance issuers providing health
insurance coverage in the individual market in a State
as provided for in such part.
(2) Clarification.--To the extent that any
provision of this part conflicts with a provision of
part A with respect to health insurance issuers
providing health insurance coverage in the individual
market in a State, the provisions of such part A shall
apply.
=======================================================================
SEC. 2763. [300GG-63] GENERAL EXCEPTIONS.
(a) Exception for Certain Benefits.--The requirements of
this part shall not apply to any health insurance coverage in
relation to its provision of excepted benefits described in
section 2791(c)(1).
(b) Exception for Certain Benefits If Certain Conditions
Met.--The requirements of this part shall not apply to any
health insurance coverage in relation to its provision of
excepted benefits described in paragraph (2), (3), or (4) of
section 2791(c) if the benefits are provided under a separate
policy, certificate, or contract of insurance.
SEC. 2753. [300GG-54] COVERAGE OF DEPENDENT STUDENTS ON MEDICALLY
NECESSARY LEAVE OF ABSENCE. \1\
---------------------------------------------------------------------------
\1\ The placement of section 2753 at the end of subpart 3 is so in
law. See amendment made by section 2(b)(2) of Public Law 110-381 122
Stat. 4084). Section 102(b)(1)(A) of Public Law 110-233 redesignated
subpart 3 of part B as subpart 2. Also, another section designated as
section 2753 was added by section 102(b)(1)(B) of such Public Law (122
Stat. 893).
---------------------------------------------------------------------------
The provisions of section 2707 shall apply to health
insurance coverage offered by a health insurance issuer in the
individual market in the same manner as they apply to health
insurance coverage offered by a health insurance issuer in
connection with a group health plan in the small or large group
market.
Part C--Definitions; Miscellaneous Provisions
SEC. 2791. [300GG-91] DEFINITIONS.
(a) Group Health Plan.--
(1) Definition.--The term ``group health plan''
means an employee welfare benefit plan (as defined in
section 3(1) of the Employee Retirement Income Security
Act of 1974) to the extent that the plan provides
medical care (as defined in paragraph (2)) and
including items and services paid for as medical care)
to employees or their dependents (as defined under the
terms of the plan) directly or through insurance,
reimbursement, or otherwise.
(2) Medical care.--The term ``medical care'' means
amounts paid for--
(A) the diagnosis, cure, mitigation,
treatment, or prevention of disease, or amounts
paid for the purpose of affecting any structure
or function of the body,
(B) amounts paid for transportation
primarily for and essential to medical care
referred to in subparagraph (A), and
(C) amounts paid for insurance covering
medical care referred to in subparagraphs (A)
and (B).
(3) Treatment of certain plans as group health plan
for notice provision.--A program under which creditable
coverage described in subparagraph (C), (D), (E), or
(F) of section 2701(c)(1) is provided shall be treated
as a group health plan for purposes of applying section
2701(e).
(b) Definitions Relating to Health Insurance.--
(1) Health insurance coverage.--The term ``health
insurance coverage'' means benefits consisting of
medical care (provided directly, through insurance or
reimbursement, or otherwise and including items and
services paid for as medical care) under any hospital
or medical service policy or certificate, hospital or
medical service plan contract, or health maintenance
organization contract offered by a health insurance
issuer.
(2) Health insurance issuer.--The term ``health
insurance issuer'' means an insurance company,
insurance service, or insurance organization (including
a health maintenance organization, as defined in
paragraph (3)) which is licensed to engage in the
business of insurance in a State and which is subject
to State law which regulates insurance (within the
meaning of section 514(b)(2) of the Employee Retirement
Income Security Act of 1974). Such term does not
include a group health plan.
(3) Health maintenance organization.--The term
``health maintenance organization'' means--
(A) a Federally qualified health
maintenance organization (as defined in section
1301(a)),
(B) an organization recognized under State
law as a health maintenance organization, or
(C) a similar organization regulated under
State law for solvency in the same manner and
to the same extent as such a health maintenance
organization.
(4) Group health insurance coverage.--The term
``group health insurance coverage'' means, in
connection with a group health plan, health insurance
coverage offered in connection with such plan.
(5) Individual health insurance coverage.--The term
``individual health insurance coverage'' means health
insurance coverage offered to individuals in the
individual market, but does not include short-term
limited duration insurance.
(c) Excepted Benefits.--For purposes of this title, the
term ``excepted benefits'' means benefits under one or more (or
any combination thereof) of the following:
(1) Benefits not subject to requirements.--
(A) Coverage only for accident, or
disability income insurance, or any combination
thereof.
(B) Coverage issued as a supplement to
liability
insurance.
(C) Liability insurance, including general
liability insurance and automobile liability
insurance.
(D) Workers' compensation or similar
insurance.
(E) Automobile medical payment insurance.
(F) Credit-only insurance.
(G) Coverage for on-site medical clinics.
(H) Other similar insurance coverage,
specified in regulations, under which benefits
for medical care are secondary or incidental to
other insurance benefits.
(2) Benefits not subject to requirements if offered
separately.--
(A) Limited scope dental or vision
benefits.
(B) Benefits for long-term care, nursing
home care, home health care, community-based
care, or any combination thereof.
(C) Such other similar, limited benefits as
are specified in regulations.
(3) Benefits not subject to requirements if offered
as independent, noncoordinated benefits.--
(A) Coverage only for a specified disease
or illness.
(B) Hospital indemnity or other fixed
indemnity insurance.
(4) Benefits not subject to requirements if offered
as separate insurance policy.--Medicare supplemental
health insurance (as defined under section 1882(g)(1)
of the Social Security Act), coverage supplemental to
the coverage provided under chapter 55 of title 10,
United States Code, and similar supplemental coverage
provided to coverage under a group health plan.
(d) \1\ Other Definitions.--
---------------------------------------------------------------------------
\1\ For version of law for section 2791(d)(20)-(21) (as amended by
section 1563(b) (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by section
10107(b)(1)) of Public Law 111-148) see note set out in italic typeface
that appears after paragraph (19).
---------------------------------------------------------------------------
(1) Applicable state authority.--The term
``applicable State authority'' means, with respect to a
health insurance issuer in a State, the State insurance
commissioner or official or officials designated by the
State to enforce the requirements of this title for the
State involved with respect to such issuer.
(2) Beneficiary.--The term ``beneficiary'' has the
meaning given such term under section 3(8) of the
Employee Retirement Income Security Act of 1974.
(3) Bona fide association.--The term ``bona fide
association'' means, with respect to health insurance
coverage offered in a State, an association which--
(A) has been actively in existence for at
least 5 years;
(B) has been formed and maintained in good
faith for purposes other than obtaining
insurance;
(C) does not condition membership in the
association on any health status-related factor
relating to an individual (including an
employee of an employer or a dependent of an
employee);
(D) makes health insurance coverage offered
through the association available to all
members regardless of any health status-related
factor relating to such members (or individuals
eligible for coverage through a member);
(E) does not make health insurance coverage
offered through the association available other
than in connection with a member of the
association; and
(F) meets such additional requirements as
may be imposed under State law.
(4) COBRA continuation provision.--The term ``COBRA
continuation provision'' means any of the following:
(A) Section 4980B of the Internal Revenue
Code of 1986, other than subsection (f)(1) of
such section insofar as it relates to pediatric
vaccines.
(B) Part 6 of subtitle B of title I of the
Employee Retirement Income Security Act of
1974, other than section 609 of such Act.
(C) Title XXII of this Act.
(5) Employee.--The term ``employee'' has the
meaning given such term under section 3(6) of the
Employee Retirement Income Security Act of 1974.
(6) Employer.--The term ``employer'' has the
meaning given such term under section 3(5) of the
Employee Retirement Income Security Act of 1974, except
that such term shall include only employers of two or
more employees.
(7) Church plan.--The term ``church plan'' has the
meaning given such term under section 3(33) of the
Employee Retirement Income Security Act of 1974.
(8) Governmental plan.--(A) The term ``governmental
plan'' has the meaning given such term under section
3(32) of the Employee Retirement Income Security Act of
1974 and any Federal governmental plan.
(B) Federal governmental plan.--The term ``Federal
governmental plan'' means a governmental plan
established or maintained for its employees by the
Government of the United States or by any agency or
instrumentality of such Government.
(C) Non-Federal governmental plan.--The term ``non-
Federal governmental plan'' means a governmental plan
that is not a Federal governmental plan.
(9) Health status-related factor.--The term
``health status-related factor'' means any of the
factors described in section 2702(a)(1).
(10) Network plan.--The term ``network plan'' means
health insurance coverage of a health insurance issuer
under which the financing and delivery of medical care
(including items and services paid for as medical care)
are provided, in whole or in part, through a defined
set of providers under contract with the issuer.
(11) Participant.--The term ``participant'' has the
meaning given such term under section 3(7) of the
Employee Retirement Income Security Act of 1974.
(12) Placed for adoption defined.--The term
``placement'', or being ``placed'', for adoption, in
connection with any placement for adoption of a child
with any person, means the assumption and retention by
such person of a legal obligation for total or partial
support of such child in anticipation of adoption of
such child. The child's placement with such person
terminates upon the termination of such legal
obligation.
(13) Plan sponsor.--The term ``plan sponsor'' has
the meaning given such term under section 3(16)(B) of
the Employee Retirement Income Security Act of 1974.
(14) State.--The term ``State'' means each of the
several States, the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa, and the
Northern Mariana Islands.
(15) Family member.--The term ``family member''
means, with respect to any individual--
(A) a dependent (as such term is used for
purposes of section 2701(f)(2)) of such
individual; and
(B) any other individual who is a first-
degree, second-degree, third-degree, or fourth-
degree relative of such individual or of an
individual described in subparagraph (A).
(16) Genetic information.--
(A) In general.--The term ``genetic
information'' means, with respect to any
individual, information about--
(i) such individual's genetic
tests,
(ii) the genetic tests of family
members of such individual, and
(iii) the manifestation of a
disease or disorder in family members
of such individual.
(B) Inclusion of genetic services and
participation in genetic research.--Such term
includes, with respect to any individual, any
request for, or receipt of, genetic services,
or participation in clinical research which
includes genetic services, by such individual
or any family member of such individual.
(C) Exclusions.--The term ``genetic
information'' shall not include information
about the sex or age of any individual.
(17) Genetic test.--
(A) In general.--The term ``genetic test''
means an analysis of human DNA, RNA,
chromosomes, proteins, or metabolites, that
detects genotypes, mutations, or chromosomal
changes.
(B) Exceptions.--The term ``genetic test''
does not mean--
(i) an analysis of proteins or
metabolites that does not detect
genotypes, mutations, or chromosomal
changes; or
(ii) an analysis of proteins or
metabolites that is directly related to
a manifested disease, disorder, or
pathological condition that could
reasonably be detected by a health care
professional with appropriate training
and expertise in the field of medicine
involved.
(18) Genetic services.--The term ``genetic
services'' means--
(A) a genetic test;
(B) genetic counseling (including
obtaining, interpreting, or assessing genetic
information); or
(C) genetic education.
(19) Underwriting purposes.--The term
``underwriting purposes'' means, with respect to any
group health plan, or health insurance coverage offered
in connection with a group health plan--
(A) rules for, or determination of,
eligibility (including enrollment and continued
eligibility) for benefits under the plan or
coverage;
(B) the computation of premium or
contribution amounts under the plan or
coverage;
(C) the application of any pre-existing
condition exclusion under the plan or coverage;
and
(D) other activities related to the
creation, renewal, or replacement of a contract
of health insurance or health benefits.
=======================================================================
[Note: Section 1563(b) (relating to conforming amendments--
originally designated as section 1562 and redesignated as
section 1563 by section 10107(b)(1)) of Public Law 111-148
provides for an amendment to add new paragraphs (20)-(21) at
the end of section 2791(d). Such amendment takes effect on date
of enactment of Public Law 111-148 (March 23, 2010); however,
they're being treated here as if they take effect on January 1,
2014 to reflect the probable intent of Congress and in order to
be consistent with the execution of different amendments made
by such section 1563 to part A of this title (see details
regarding the effective date in a note to a second version of
part A). Upon such date, paragraphs (20)-(21) read as follows:]
(20) Qualified health plan.--The term ``qualified
health plan'' has the meaning given such term in
section 1301(a) of the Patient Protection and
Affordable Care Act.
(21) Exchange.--The term ``Exchange'' means an
American Health Benefit Exchange established under
section 1311 of the Patient Protection and Affordable
Care Act.
=======================================================================
(e) Definitions Relating to Markets and Small Em-
ployers.--For purposes of this title:
(1) Individual market.--
(A) In general.--The term ``individual
market'' means the market for health insurance
coverage offered to individuals other than in
connection with a group health plan.
(B) Treatment of very small groups.--
(i) In general.--Subject to clause
(ii), such terms includes coverage
offered in connection with a group
health plan that has fewer than two
participants as current employees on
the first day of the plan year.
(ii) State exception.--Clause (i)
shall not apply in the case of a State
that elects to regulate the coverage
described in such clause as coverage in
the small group market.
(2) Large employer.--The term ``large employer''
means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer
who employed an average of at least 51 \1\ employees on
business days during the preceding calendar year and
who employs at least 2 employees on the first day of
the plan year.
---------------------------------------------------------------------------
\1\ Section 1563(c)(16)(A) (relating to conforming amendments--
originally designated as section 1562 and redesignated as section 1563
by section 10107(b)(1)) of Public Law 111-148 provides for an amendment
to section 2791(e)(2) by striking ``51'' and inserting ``101''.
The amendment to section 2791(e) made by section 1563(c)(16)(A),
as so redesignated, takes effect on date of enactment of Public Law
111-148 (March 23, 2010); however, they're being treated here as if
they take effect on January 1, 2014 to reflect the probable intent of
Congress and in order to be consistent with the execution of different
amendments made by such section 1563 to part A of this title (see
details regarding the effective date in a note to a second version of
part A).
---------------------------------------------------------------------------
(3) Large group market.--The term ``large group
market'' means the health insurance market under which
individuals obtain health insurance coverage (directly
or through any arrangement) on behalf of themselves
(and their dependents) through a group health plan
maintained by a large employer.
(4) \2\ Small employer.--The term ``small
employer'' means, in connection with a group health
plan with respect to a calendar year and a plan year,
an employer who employed an average of at least 2 but
not more than 50 employees on business days during the
preceding calendar year and who employs at least 2
employees on the first day of the plan year.
---------------------------------------------------------------------------
\2\ For version of law of paragraph (4) (as amended by section
1563(c)(16)(B) (relating to conforming amendments--originally
designated as section 1562 and redesignated as section 1563 by section
10107(b)(1)) of Public Law 111-148) see note set out in italic typeface
that appears after this paragraph.
---------------------------------------------------------------------------
=======================================================================
[Note: Section 1563(c)(16)(B) (relating to conforming
amendments--originally designated as section 1562 and
redesignated as section 1563 by section 10107(b)(1)) of Public
Law 111-148 provides for amendments to paragraph (4) of section
2791(e). Such amendments take effect on date of enactment of
Public Law 111-148 (March 23, 2010); however, they're being
treated here as if they take effect on January 1, 2014 to
reflect the probable intent of Congress and in order to be
consistent with the execution of different amendments made by
such section 1563 to part A of this title (see details
regarding the effective date in a note to a second version of
part A). Upon such date, paragraph (4) reads as follows:]
(4) Small employer.--The term ``small employer''
means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer
who employed an average of at least 1 but not more than
100 employees on business days during the preceding
calendar year and who employs at least 1 employees on
the first day of the plan year.
=======================================================================
(5) Small group market.--The term ``small group
market'' means the health insurance market under which
individuals obtain health insurance coverage (directly
or through any arrangement) on behalf of themselves
(and their dependents) through a group health plan
maintained by a small employer.
(6) Application of certain rules in determination
of employer size.--For purposes of this subsection--
(A) Application of aggregation rule for
employers.--all persons treated as a single
employer under subsection (b), (c), (m), or (o)
of section 414 of the Internal Revenue Code of
1986 shall be treated as 1 employer.
(B) Employers not in existence in preceding
year.--In the case of an employer which was not
in existence throughout the preceding calendar
year, the determination of whether such
employer is a small or large employer shall be
based on the average number of employees that
it is reasonably expected such employer will
employ on business days in the current calendar
year.
(C) Predecessors.--Any reference in this
subsection to an employer shall include a
reference to any predecessor of such employer.
SEC. 2792. [300GG-92] REGULATIONS.
The Secretary, consistent with section 104 of the Health
Care Portability and Accountability Act of 1996, may promulgate
such regulations as may be necessary or appropriate to carry
out the provisions of this title. The Secretary may promulgate
any interim final rules as the Secretary determines are
appropriate to carry out this title.
SEC. 2793. [300GG-93] HEALTH INSURANCE CONSUMER INFORMATION.
(a) In General.--The Secretary shall award grants to States
to enable such States (or the Exchanges operating in such
States) to establish, expand, or provide support for--
(1) offices of health insurance consumer
assistance; or
(2) health insurance ombudsman programs.
(b) Eligibility.--
(1) In general.--To be eligible to receive a grant,
a State shall designate an independent office of health
insurance consumer assistance, or an ombudsman, that,
directly or in coordination with State health insurance
regulators and consumer assistance organizations,
receives and responds to inquiries and complaints
concerning health insurance coverage with respect to
Federal health insurance requirements and under State
law.
(2) Criteria.--A State that receives a grant under
this section shall comply with criteria established by
the Secretary for carrying out activities under such
grant.
(c) Duties.--The office of health insurance consumer
assistance or health insurance ombudsman shall--
(1) assist with the filing of complaints and
appeals, including filing appeals with the internal
appeal or grievance process of the group health plan or
health insurance issuer involved and providing
information about the external appeal process;
(2) collect, track, and quantify problems and
inquiries encountered by consumers;
(3) educate consumers on their rights and
responsibilities with respect to group health plans and
health insurance coverage;
(4) assist consumers with enrollment in a group
health plan or health insurance coverage by providing
information, referral, and assistance; and
(5) resolve problems with obtaining premium tax
credits under section 36B of the Internal Revenue Code
of 1986.
(d) Data Collection.--As a condition of receiving a grant
under subsection (a), an office of health insurance consumer
assistance or ombudsman program shall be required to collect
and report data to the Secretary on the types of problems and
inquiries encountered by consumers. The Secretary shall utilize
such data to identify areas where more enforcement action is
necessary and shall share such information with State insurance
regulators, the Secretary of Labor, and the Secretary of the
Treasury for use in the enforcement activities of such
agencies.
(e) Funding.--
(1) Initial funding.--There is hereby appropriated
to the Secretary, out of any funds in the Treasury not
otherwise appropriated, $30,000,000 for the first
fiscal year for which this section applies to carry out
this section. Such amount shall remain available
without fiscal year limitation.
(2) Authorization for subsequent years.--There is
authorized to be appropriated to the Secretary for each
fiscal year following the fiscal year described in
paragraph (1), such sums as may be necessary to carry
out this section.
SEC. 2794. [300GG-94] ENSURING THAT CONSUMERS GET VALUE FOR THEIR
DOLLARS.
(a) Initial Premium Review Process.--
(1) In general.--The Secretary, in conjunction with
States, shall establish a process for the annual
review, beginning with the 2010 plan year and subject
to subsection (b)(2)(A), of unreasonable increases in
premiums for health insurance coverage.
(2) Justification and disclosure.--The process
established under paragraph (1) shall require health
insurance issuers to submit to the Secretary and the
relevant State a justification for an unreasonable
premium increase prior to the implementation of the
increase. Such issuers shall prominently post such
information on their Internet websites. The Secretary
shall ensure the public disclosure of information on
such increases and justifications for all health
insurance issuers.
(b) Continuing Premium Review Process.--
(1) Informing secretary of premium increase
patterns.--As a condition of receiving a grant under
subsection (c)(1), a State, through its Commissioner of
Insurance, shall--
(A) provide the Secretary with information
about trends in premium increases in health
insurance coverage in premium rating areas in
the State; and
(B) make recommendations, as appropriate,
to the State Exchange about whether particular
health insurance issuers should be excluded
from participation in the Exchange based on a
pattern or practice of excessive or unjustified
premium increases.
(2) Monitoring by secretary of premium increases.--
(A) In general.--Beginning with plan years
beginning in 2014, the Secretary, in
conjunction with the States and consistent with
the provisions of subsection (a)(2), shall
monitor premium increases of health insurance
coverage offered through an Exchange and
outside of an Exchange.
(B) Consideration in opening exchange.--In
determining under section 1312(f)(2)(B) of the
Patient Protection and Affordable Care Act
whether to offer qualified health plans in the
large group market through an Exchange, the
State shall take into account any excess of
premium growth outside of the Exchange as
compared to the rate of such growth inside the
Exchange.
(c) Grants in Support of Process.--
(1) Premium review grants during 2010 through
2014.--The Secretary shall carry out a program to award
grants to States during the 5-year period beginning
with fiscal year 2010 to assist such States in carrying
out subsection (a), including--
(A) in reviewing and, if appropriate under
State law, approving premium increases for
health insurance coverage;
(B) in providing information and
recommendations to the Secretary under
subsection (b)(1); and
(C) in establishing centers (consistent
with subsection (d)) at academic or other
nonprofit institutions to collect medical
reimbursement information from health insurance
issuers, to analyze and organize such
information, and to make such information
available to such issuers, health care
providers, health researchers, health care
policy makers, and the general public.
(2) Funding.--
(A) In general.--Out of all funds in the
Treasury not otherwise appropriated, there are
appropriated to the Secretary $250,000,000, to
be available for expenditure for grants under
paragraph (1) and subparagraph (B).
(B) Further availability for insurance
reform and consumer protection.--If the amounts
appropriated under subparagraph (A) are not
fully obligated under grants under paragraph
(1) by the end of fiscal year 2014, any
remaining funds shall remain available to the
Secretary for grants to States for planning and
implementing the insurance reforms and consumer
protections under part A.
(C) Allocation.--The Secretary shall
establish a formula for determining the amount
of any grant to a State under this subsection.
Under such formula--
(i) the Secretary shall consider
the number of plans of health insurance
coverage offered in each State and the
population of the State; and
(ii) no State qualifying for a
grant under paragraph (1) shall receive
less than $1,000,000, or more than
$5,000,000 for a grant year.
(d) Medical Reimbursement Data Centers.--
(1) Functions.--A center established under
subsection (c)(1)(C) shall--
(A) develop fee schedules and other
database tools that fairly and accurately
reflect market rates for medical services and
the geographic differences in those rates;
(B) use the best available statistical
methods and data processing technology to
develop such fee schedules and other database
tools;
(C) regularly update such fee schedules and
other database tools to reflect changes in
charges for medical services;
(D) make health care cost information
readily available to the public through an
Internet website that allows consumers to
understand the amounts that health care
providers in their area charge for particular
medical services; and
(E) regularly publish information
concerning the statistical methodologies used
by the center to analyze health charge data and
make such data available to researchers and
policy makers.
(2) Conflicts of interest.--A center established
under subsection (c)(1)(C) shall adopt by-laws that
ensures that the center (and all members of the
governing board of the center) is independent and free
from all conflicts of interest. Such by-laws shall
ensure that the center is not controlled or influenced
by, and does not have any corporate relation to, any
individual or entity that may make or receive payments
for health care services based on the center's analysis
of health care costs.
(3) Rule of construction.--Nothing in this
subsection shall be construed to permit a center
established under subsection (c)(1)(C) to compel health
insurance issuers to provide data to the center.
SEC. 2794. [300GG-95] UNIFORM FRAUD AND ABUSE REFERRAL FORMAT. \1\
---------------------------------------------------------------------------
\1\ So in law. There are two sections 2794s'. Sections 1003 and
6603 of Public Law 111-148 add new section 2794s' to the end of part C
of title XXVII.
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The Secretary shall request the National Association of
Insurance Commissioners to develop a model uniform report form
for private health insurance issuer seeking to refer suspected
fraud and abuse to State insurance departments or other
responsible State agencies for investigation. The Secretary
shall request that the National Association of Insurance
Commissioners develop recommendations for uniform reporting
standards for such referrals.ATTORNEY: PMG/VLC (July
10, 2002) deg.
TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH
EMERGENCIES
Subtitle A--National All-Hazards Preparedness and Response Planning,
Coordinating, and Reporting
SEC. 2801. [300HH] PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE
FUNCTIONS.
(a) In General.--The Secretary of Health and Human Services
shall lead all Federal public health and medical response to
public health emergencies and incidents covered by the National
Response Plan developed pursuant to section 502(6) of the
Homeland Security Act of 2002, or any successor plan.
(b) Interagency Agreement.--The Secretary, in collaboration
with the Secretary of Veterans Affairs, the Secretary of
Transportation, the Secretary of Defense, the Secretary of
Homeland Security, and the head of any other relevant Federal
agency, shall establish an interagency agreement, consistent
with the National Response Plan or any successor plan, under
which agreement the Secretary of Health and Human Services
shall assume operational control of emergency public health and
medical response assets, as necessary, in the event of a public
health emergency, except that members of the armed forces under
the authority of the Secretary of Defense shall remain under
the command and control of the Secretary of Defense, as shall
any associated assets of the Department of Defense.
SEC. 2802. [300HH-1] NATIONAL HEALTH SECURITY STRATEGY.
(a) In General.--
(1) Preparedness and response regarding public
health emergencies.--Beginning in 2009 and every four
years thereafter, the Secretary shall prepare and
submit to the relevant committees of Congress a
coordinated strategy (to be known as the National
Health Security Strategy) and any revisions thereof,
and an accompanying implementation plan for public
health emergency preparedness and response. Such
National Health Security Strategy shall identify the
process for achieving the preparedness goals described
in subsection (b) and shall be consistent with the
National Preparedness Goal, the National Incident
Management System, and the National Response Plan
developed pursuant to section 502(6) of the Homeland
Security Act of 2002, or any successor plan.
(2) Evaluation of progress.--The National Health
Security Strategy shall include an evaluation of the
progress made by Federal, State, local, and tribal
entities, based on the evidence-based benchmarks and
objective standards that measure levels of preparedness
established pursuant to section 319C-1(g). Such
evaluation shall include aggregate and State-specific
breakdowns of obligated funding spent by major category
(as defined by the Secretary) for activities funded
through awards pursuant to sections 319C-1 and 319C-2.
(3) Public health workforce.--In 2009, the National
Health Security Strategy shall include a national
strategy for establishing an effective and prepared
public health workforce, including defining the
functions, capabilities, and gaps in such workforce,
and identifying strategies to recruit, retain, and
protect such workforce from workplace exposures during
public health emergencies.
(b) Preparedness Goals.--The National Health Security
Strategy shall include provisions in furtherance of the
following:
(1) Integration.--Integrating public health and
public and private medical capabilities with other
first responder systems, including through--
(A) the periodic evaluation of Federal,
State, local, and tribal preparedness and
response capabilities through drills and
exercises; and
(B) integrating public and private sector
public health and medical donations and
volunteers.
(2) Public health.--Developing and sustaining
Federal, State, local, and tribal essential public
health security capabilities, including the following:
(A) Disease situational awareness
domestically and abroad, including detection,
identification, and investigation.
(B) Disease containment including
capabilities for isolation, quarantine, social
distancing, and decontamination.
(C) Risk communication and public
preparedness.
(D) Rapid distribution and administration
of medical countermeasures.
(3) Medical.--Increasing the preparedness, response
capabilities, and surge capacity of hospitals, other
health care facilities (including mental health
facilities), and trauma care and emergency medical
service systems, with respect to public health
emergencies, which shall include developing plans for
the following:
(A) Strengthening public health emergency
medical management and treatment capabilities.
(B) Medical evacuation and fatality
management.
(C) Rapid distribution and administration
of medical countermeasures.
(D) Effective utilization of any available
public and private mobile medical assets and
integration of other Federal assets.
(E) Protecting health care workers and
health care first responders from workplace
exposures during a public health emergency.
(4) At-risk individuals.--
(A) Taking into account the public health
and medical needs of at-risk individuals in the
event of a public health emergency.
(B) For purpose of this section and
sections 319C-1, 319F, and 319L, the term ``at-
risk individuals'' means children, pregnant
women, senior citizens and other individuals
who have special needs in the event of a public
health emergency, as determined by the
Secretary.
(5) Coordination.--Minimizing duplication of, and
ensuring coordination between, Federal, State, local,
and tribal planning, preparedness, and response
activities (including the State Emergency Management
Assistance Compact). Such planning shall be consistent
with the National Response Plan, or any successor plan,
and National Incident Management System and the
National Preparedness Goal.
(6) Continuity of operations.--Maintaining vital
public health and medical services to allow for optimal
Federal, State, local, and tribal operations in the
event of a public health emergency.
SEC. 2803. [300HH-2] ENHANCING MEDICAL SURGE CAPACITY.
(a) Study of Enhancing Medical Surge Capacity.--As part of
the joint review described in section 2812(b), the Secretary
shall evaluate the benefits and feasibility of improving the
capacity of the Department of Health and Human Services to
provide additional medical surge capacity to local communities
in the event of a public health emergency. Such study shall
include an assessment of the need for and feasibility of
improving surge capacity through--
(1) acquisition and operation of mobile medical
assets by the Secretary to be deployed, on a
contingency basis, to a community in the event of a
public health emergency;
(2) integrating the practice of telemedicine within
the National Disaster Medical System; and
(3) other strategies to improve such capacity as
determined appropriate by the Secretary.
(b) Authority To Acquire and Operate Mobile Medical
Assets.--In addition to any other authority to acquire, deploy,
and operate mobile medical assets, the Secretary may acquire,
deploy, and operate mobile medical assets if, taking into
consideration the evaluation conducted under subsection (a),
such acquisition, deployment, and operation is determined to be
beneficial and feasible in improving the capacity of the
Department of Health and Human Services to provide additional
medical surge capacity to local communities in the event of a
public health emergency.
(c) Using Federal Facilities To Enhance Medical Surge
Capacity.--
(1) Analysis.--The Secretary shall conduct an
analysis of whether there are Federal facilities which,
in the event of a public health emergency, could
practicably be used as facilities in which to provide
health care.
(2) Memoranda of understanding.--If, based on the
analysis conducted under paragraph (1), the Secretary
determines that there are Federal facilities which, in
the event of a public health emergency, could be used
as facilities in which to provide health care, the
Secretary shall, with respect to each such facility,
seek to conclude a memorandum of understanding with the
head of the Department or agency that operates such
facility that permits the use of such facility to
provide health care in the event of a public health
emergency.
Subtitle B--All-Hazards Emergency Preparedness and Response
SEC. 2811. [300HH-10] COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.
(a) In General.--There is established within the Department
of Health and Human Services the position of the Assistant
Secretary for Preparedness and Response. The President, with
the advice and consent of the Senate, shall appoint an
individual to serve in such position. Such Assistant Secretary
shall report to the Secretary.
(b) Duties.--Subject to the authority of the Secretary, the
Assistant Secretary for Preparedness and Response shall carry
out the following functions:
(1) Leadership.--Serve as the principal advisor to
the Secretary on all matters related to Federal public
health and medical preparedness and response for public
health emergencies.
(2) Personnel.--Register, credential, organize,
train, equip, and have the authority to deploy Federal
public health and medical personnel under the authority
of the Secretary, including the National Disaster
Medical System, and coordinate such personnel with the
Medical Reserve Corps and the Emergency System for
Advance Registration of Volunteer Health Professionals.
(3) Countermeasures.--Oversee advanced research,
development, and procurement of qualified
countermeasures (as defined in section 319F-1) and
qualified pandemic or epidemic products (as defined in
section 319F-3).
(4) Coordination.--
(A) Federal integration.--Coordinate with
relevant Federal officials to ensure
integration of Federal preparedness and
response activities for public health
emergencies.
(B) State, local, and tribal integration.--
Coordinate with State, local, and tribal public
health officials, the Emergency Management
Assistance Compact, health care systems, and
emergency medical service systems to ensure
effective integration of Federal public health
and medical assets during a public health
emergency.
(C) Emergency medical services.--Promote
improved emergency medical services medical
direction, system integration, research, and
uniformity of data collection, treatment
protocols, and policies with regard to public
health emergencies.
(5) Logistics.--In coordination with the Secretary
of Veterans Affairs, the Secretary of Homeland
Security, the General Services Administration, and
other public and private entities, provide logistical
support for medical and public health aspects of
Federal responses to public health emergencies.
(6) Leadership.--Provide leadership in
international programs, initiatives, and policies that
deal with public health and medical emergency
preparedness and response.
(c) Functions.--The Assistant Secretary for Preparedness
and Response shall--
(1) have authority over and responsibility for--
(A) the National Disaster Medical System
(in accordance with section 301 of the Pandemic
and All-Hazards Preparedness Act); and
(B) the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C-2;
(2) exercise the responsibilities and authorities
of the Secretary with respect to the coordination of--
(A) the Medical Reserve Corps pursuant to
section 2813;
(B) the Emergency System for Advance
Registration of Volunteer Health Professionals
pursuant to section 319I;
(C) the Strategic National Stockpile; and
(D) the Cities Readiness Initiative; and
(3) assume other duties as determined appropriate
by the Secretary.
SEC. 2812. [300HH-11] NATIONAL DISASTER MEDICAL SYSTEM.
(a) National Disaster Medical System.--
(1) In general.--The Secretary shall provide for
the operation in accordance with this section of a
system to be known as the National Disaster Medical
System. The Secretary shall designate the Assistant
Secretary for Preparedness and Response as the head of
the National Disaster Medical System, subject to the
authority of the Secretary.
(2) Federal and state collaborative system.--
(A) In general.--The National Disaster
Medical System shall be a coordinated effort by
the Federal agencies specified in subparagraph
(B), working in collaboration with the States
and other appropriate public or private
entities, to carry out the purposes described
in paragraph (3).
(B) Participating federal agencies.--The
Federal agencies referred to in subparagraph
(A) are the Department of Health and Human
Services, the Department of Homeland Security,
the Department of Defense, and the Department
of Veterans Affairs.
(3) Purpose of system.--
(A) In general.--The Secretary may activate
the National Disaster Medical System to--
(i) provide health services,
health-related social services, other
appropriate human services, and
appropriate auxiliary services to
respond to the needs of victims of a
public health emergency (whether or not
determined to be a public health
emergency under section 319); or
(ii) be present at locations, and
for limited periods of time, specified
by the Secretary on the basis that the
Secretary has determined that a
location is at risk of a public health
emergency during the time specified.
(B) Ongoing activities.--The National
Disaster Medical System shall carry out such
ongoing activities as may be necessary to
prepare for the provision of services described
in subparagraph (A) in the event that the
Secretary activates the National Disaster
Medical System for such purposes.
(C) Test for mobilization of system.--
During the one-year period beginning on the
date of the enactment of the Pandemic and All-
Hazards Preparedness Act, the Secretary shall
conduct an exercise to test the capability and
timeliness of the National Disaster Medical
System to mobilize and otherwise respond
effectively to a bioterrorist attack or other
public health emergency that affects two or
more geographic locations concurrently.
Thereafter, the Secretary may periodically
conduct such exercises regarding the National
Disaster Medical System as the Secretary
determines to be appropriate.
(b) Modifications.--
(1) In general.--Taking into account the findings
from the joint review described under paragraph (2),
the Secretary shall modify the policies of the National
Disaster Medical System as necessary.
(2) Joint review and medical surge capacity
strategic plan.--Not later than 180 days after the date
of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary, in coordination with
the Secretary of Homeland Security, the Secretary of
Defense, and the Secretary of Veterans Affairs, shall
conduct a joint review of the National Disaster Medical
System. Such review shall include an evaluation of
medical surge capacity, as described by section
2803(a). As part of the National Health Security
Strategy under section 2802, the Secretary shall update
the findings from such review and further modify the
policies of the National Disaster Medical System as
necessary.
(3) Participation agreements for non-federal
entities.--In carrying out paragraph (1), the Secretary
shall establish criteria regarding the participation of
States and private entities in the National Disaster
Medical System, including criteria regarding agreements
for such participation. The criteria shall include the
following:
(A) Provisions relating to the custody and
use of Federal personal property by such
entities, which may in the discretion of the
Secretary include authorizing the custody and
use of such property to respond to emergency
situations for which the National Disaster
Medical System has not been activated by the
Secretary pursuant to subsection (a)(3)(A). Any
such custody and use of Federal personal
property shall be on a reimbursable basis.
(B) Provisions relating to circumstances in
which an individual or entity has agreements
with both the National Disaster Medical System
and another entity regarding the provision of
emergency services by the individual. Such
provisions shall address the issue of
priorities among the agreements involved.
(c) Intermittent Disaster-Response Personnel.--
(1) In general.--For the purpose of assisting the
National Disaster Medical System in carrying out duties
under this section, the Secretary may appoint
individuals to serve as intermittent personnel of such
System in accordance with applicable civil service laws
and regulations.
(2) Liability.--For purposes of section 224(a) and
the remedies described in such section, an individual
appointed under paragraph (1) shall, while acting
within the scope of such appointment, be considered to
be an employee of the Public Health Service performing
medical, surgical, dental, or related functions. With
respect to the participation of individuals appointed
under paragraph (1) in training programs authorized by
the Assistant Secretary for Preparedness and Response
or a comparable official of any Federal agency
specified in subsection (a)(2)(B), acts of individuals
so appointed that are within the scope of such
participation shall be considered within the scope of
the appointment under paragraph (1) (regardless of
whether the individuals receive compensation for such
participation).
(d) Certain Employment Issues Regarding Intermittent
Appointments.--
(1) Intermittent disaster-response appointee.--For
purposes of this subsection, the term ``intermittent
disaster-response appointee'' means an individual
appointed by the Secretary under subsection (c).
(2) Compensation for work injuries.--An
intermittent disaster-response appointee shall, while
acting in the scope of such appointment, be considered
to be an employee of the Public Health Service
performing medical, surgical, dental, or related
functions, and an injury sustained by such an
individual shall be deemed ``in the performance of
duty'', for purposes of chapter 81 of title 5, United
States Code, pertaining to compensation for work
injuries. With respect to the participation of
individuals appointed under subsection (c) in training
programs authorized by the Assistant Secretary for
Preparedness and Response or a comparable official of
any Federal agency specified in subsection (a)(2)(B),
injuries sustained by such an individual, while acting
within the scope of such participation, also shall be
deemed ``in the performance of duty'' for purposes of
chapter 81 of title 5, United States Code (regardless
of whether the individuals receive compensation for
such participation). In the event of an injury to such
an intermittent disaster-response appointee, the
Secretary of Labor shall be responsible for making
determinations as to whether the claimant is entitled
to compensation or other benefits in accordance with
chapter 81 of title 5, United States Code.
(3) Employment and reemployment rights.--
(A) In general.--Service as an intermittent
disaster-response appointee when the Secretary
activates the National Disaster Medical System
or when the individual participates in a
training program authorized by the Assistant
Secretary for Preparedness and Response or a
comparable official of any Federal agency
specified in subsection (a)(2)(B) shall be
deemed ``service in the uniformed services''
for purposes of chapter 43 of title 38, United
States Code, pertaining to employment and
reemployment rights of individuals who have
performed service in the uniformed services
(regardless of whether the individual receives
compensation for such participation). All
rights and obligations of such persons and
procedures for assistance, enforcement, and
investigation shall be as provided for in
chapter 43 of title 38, United States Code.
(B) Notice of absence from position of
employment.--Preclusion of giving notice of
service by necessity of Service as an
intermittent disaster-response appointee when
the Secretary activates the National Disaster
Medical System shall be deemed preclusion by
``military necessity'' for purposes of section
4312(b) of title 38, United States Code,
pertaining to giving notice of absence from a
position of employment. A determination of such
necessity shall be made by the Secretary, in
consultation with the Secretary of Defense, and
shall not be subject to judicial review.
(4) Limitation.--An intermittent disaster-response
appointee shall not be deemed an employee of the
Department of Health and Human Services for purposes
other than those specifically set forth in this
section.
(e) Rule of Construction Regarding Use of Commissioned
Corps.--If the Secretary assigns commissioned officers of the
Regular or Reserve Corps to serve with the National Disaster
Medical System, such assignments do not affect the terms and
conditions of their appointments as commissioned officers of
the Regular or Reserve Corps, respectively (including with
respect to pay and allowances, retirement, benefits, rights,
privileges, and immunities).
(f) Definition.--For purposes of this section, the term
``auxiliary services'' includes mortuary services, veterinary
services, and other services that are determined by the
Secretary to be appropriate with respect to the needs referred
to in subsection (a)(3)(A).
(g) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Preparedness and
Response and the operations of the National Disaster Medical
System, other than purposes for which amounts in the Public
Health Emergency Fund under section 319 are available, there
are authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2007 through 2011.
SEC. 2813. [300HH-15] VOLUNTEER MEDICAL RESERVE CORPS.
(a) In General.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary, in collaboration with State, local, and tribal
officials, shall build on State, local, and tribal programs in
existence on the date of enactment of such Act to establish and
maintain a Medical Reserve Corps (referred to in this section
as the ``Corps'') to provide for an adequate supply of
volunteers in the case of a Federal, State, local, or tribal
public health emergency. The Corps shall be headed by a
Director who shall be appointed by the Secretary and shall
oversee the activities of the Corps chapters that exist at the
State, local, and tribal levels.
(b) State, Local, and Tribal Coordination.--The Corps shall
be established using existing State, local, and tribal teams
and shall not alter such teams.
(c) Composition.--The Corps shall be composed of
individuals who--
(1)(A) are health professionals who have
appropriate professional training and expertise as
determined appropriate by the Director of the Corps; or
(B) are non-health professionals who have an
interest in serving in an auxiliary or support capacity
to facilitate access to health care services in a
public health emergency;
(2) are certified in accordance with the
certification program developed under subsection (d);
(3) are geographically diverse in residence;
(4) have registered and carry out training
exercises with a local chapter of the Medical Reserve
Corps; and
(5) indicate whether they are willing to be
deployed outside the area in which they reside in the
event of a public health emergency.
(d) Certification; Drills.--
(1) Certification.--The Director, in collaboration
with State, local, and tribal officials, shall
establish a process for the periodic certification of
individuals who volunteer for the Corps, as determined
by the Secretary, which shall include the completion by
each individual of the core training programs developed
under section 319F, as required by the Director. Such
certification shall not supercede State licensing or
credentialing requirements.
(2) Drills.--In conjunction with the core training
programs referred to in paragraph (1), and in order to
facilitate the integration of trained volunteers into
the health care system at the local level, Corps
members shall engage in periodic training exercises to
be carried out at the local level.
(e) Deployment.--During a public health emergency, the
Secretary shall have the authority to activate and deploy
willing members of the Corps to areas of need, taking into
consideration the public health and medical expertise required,
with the concurrence of the State, local, or tribal officials
from the area where the members reside.
(f) Expenses and Transportation.--While engaged in
performing duties as a member of the Corps pursuant to an
assignment by the Secretary (including periods of travel to
facilitate such assignment), members of the Corps who are not
otherwise employed by the Federal Government shall be allowed
travel or transportation expenses, including per diem in lieu
of subsistence.
(g) Identification.--The Secretary, in cooperation and
consultation with the States, shall develop a Medical Reserve
Corps Identification Card that describes the licensure and
certification information of Corps members, as well as other
identifying information determined necessary by the Secretary.
(h) Intermittent Disaster-Response Personnel.--
(1) In general.--For the purpose of assisting the
Corps in carrying out duties under this section, during
a public health emergency, the Secretary may appoint
selected individuals to serve as intermittent personnel
of such Corps in accordance with applicable civil
service laws and regulations. In all other cases,
members of the Corps are subject to the laws of the
State in which the activities of the Corps are
undertaken.
(2) Applicable protections.--Subsections (c)(2),
(d), and (e) of section 2812 shall apply to an
individual appointed under paragraph (1) in the same
manner as such subsections apply to an individual
appointed under section 2812(c).
(3) Limitation.--State, local, and tribal officials
shall have no authority to designate a member of the
Corps as Federal intermittent disaster-response
personnel, but may request the services of such
members.
(i) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $22,000,000 for
fiscal year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011.
SEC. 2814. [300HH-16] AT-RISK INDIVIDUALS.
The Secretary, acting through such employee of the
Department of Health and Human Services as determined by the
Secretary and designated publicly (which may, at the discretion
of the Secretary, involve the appointment or designation of an
individual as the Director of At-Risk Individuals), shall--
(1) oversee the implementation of the National
Preparedness goal of taking into account the public
health and medical needs of at-risk individuals in the
event of a public health emergency, as described in
section 2802(b)(4);
(2) assist other Federal agencies responsible for
planning for, responding to, and recovering from public
health emergencies in addressing the needs of at-risk
individuals;
(3) provide guidance to and ensure that recipients
of State and local public health grants include
preparedness and response strategies and capabilities
that take into account the medical and public health
needs of at-risk individuals in the event of a public
health emergency, as described in section 319C-
1(b)(2)(A)(iii);
(4) ensure that the contents of the strategic
national stockpile take into account at-risk
populations as described in section 2811(b)(3)(B);
(5) oversee the progress of the Advisory Committee
on At-Risk Individuals and Public Health Emergencies
established under section 319F(b)(2) and make
recommendations with a focus on opportunities for
action based on the work of the Committee;
(6) oversee curriculum development for the public
health and medical response training program on medical
management of casualties, as it concerns at-risk
individuals as described in subparagraphs (A) through
(C) of section 319F(a)(2);
(7) disseminate novel and best practices of
outreach to and care of at-risk individuals before,
during, and following public health emergencies; and
(8) not later than one year after the date of
enactment of the Pandemic and All-Hazards Preparedness
Act, prepare and submit to Congress a report describing
the progress made on implementing the duties described
in this section.
SEC. 2815. [42 U.S.C. 300HH-17] EMERGENCY RESPONSE COORDINATION OF
PRIMARY CARE PROVIDERS.
The Secretary, acting through Administrator \1\ of the
Health Resources and Services Administration, and in
coordination with the Assistant Secretary for Preparedness and
Response, shall
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\1\ So in law. Probably should read ``the Administrator''.
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(1) provide guidance and technical assistance to
health centers funded under section 330 and to State
and local health departments and emergency managers to
integrate health centers into State and local emergency
response plans and to better meet the primary care
needs of populations served by health centers during
public health emergencies; and
(2) encourage employees at health centers funded
under section 330 to participate in emergency medical
response programs including the National Disaster
Medical System authorized in section 2812, the
Volunteer Medical Reserve Corps authorized in section
2813, and the Emergency System for Advance Registration
of Health Professions Volunteers authorized in section
319I.
Subtitle C--Strengthening Public Health Surveillance Systems
SEC. 2821. [300HH-31] EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS.
(a) In General.--Subject to the availability of
appropriations, the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall establish
an Epidemiology and Laboratory Capacity Grant Program to award
grants to State health departments as well as local health
departments and tribal jurisdictions that meet such criteria as
the Director determines appropriate. Academic centers that
assist State and eligible local and tribal health departments
may also be eligible for funding under this section as the
Director determines appropriate. Grants shall be awarded under
this section to assist public health agencies in improving
surveillance for, and response to, infectious diseases and
other conditions of public health importance by--
(1) strengthening epidemiologic capacity to
identify and monitor the occurrence of infectious
diseases and other conditions of public health
importance;
(2) enhancing laboratory practice as well as
systems to report test orders and results
electronically;
(3) improving information systems including
developing and maintaining an information exchange
using national guidelines and complying with capacities
and functions determined by an advisory council
established and appointed by the Director; and
(4) developing and implementing prevention and
control strategies.
(b) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $190,000,000 for
each of fiscal years 2010 through 2013, of which--
(1) not less than $95,000,000 shall be made
available each such fiscal year for activities under
paragraphs (1) and (4) of subsection (a);
(2) not less than $60,000,000 shall be made
available each such fiscal year for activities under
subsection (a)(3); and
(3) not less than $32,000,000 shall be made
available each such fiscal year for activities under
subsection (a)(2).ATTORNEY: PMG/VLC (July 10,
2002) deg.
TITLE XXIX--LIFESPAN RESPITE CARE
SEC. 2901. [300II] DEFINITIONS.
In this title:
(1) Adult with a special need.--The term ``adult
with a special need'' means a person 18 years of age or
older who requires care or supervision to--
(A) meet the person's basic needs;
(B) prevent physical self-injury or injury
to others; or
(C) avoid placement in an institutional
facility.
(2) Aging and disability resource center.--The term
``aging and disability resource center'' means an
entity administering a program established by the
State, as part of the State's system of long-term care,
to provide a coordinated system for providing--
(A) comprehensive information on available
public and private long-term care programs,
options, and resources;
(B) personal counseling to assist
individuals in assessing their existing or
anticipated long-term care needs, and
developing and implementing a plan for long-
term care designed to meet their specific needs
and circumstances; and
(C) consumer access to the range of
publicly supported long-term care programs for
which consumers may be eligible, by serving as
a convenient point of entry for such programs.
(3) Child with a special need.--The term ``child
with a special need'' means an individual less than 18
years of age who requires care or supervision beyond
that required of children generally to--
(A) meet the child's basic needs; or
(B) prevent physical injury, self-injury,
or injury to others.
(4) Eligible state agency.--The term ``eligible
State agency'' means a State agency that--
(A) administers the State's program under
the Older Americans Act of 1965, administers
the State's program under title XIX of the
Social Security Act, or is designated by the
Governor of such State to administer the
State's programs under this title;
(B) is an aging and disability resource
center;
(C) works in collaboration with a public or
private nonprofit statewide respite care
coalition or organization; and
(D) demonstrates--
(i) an ability to work with other
State and community-based agencies;
(ii) an understanding of respite
care and family caregiver issues across
all age groups, disabilities, and
chronic conditions; and
(iii) the capacity to ensure
meaningful involvement of family
members, family caregivers, and care
recipients.
(5) Family caregiver.--The term ``family
caregiver'' means an unpaid family member, a foster
parent, or another unpaid adult, who provides in-home
monitoring, management, supervision, or treatment of a
child or adult with a special need.
(6) Lifespan respite care.--The term ``lifespan
respite care'' means a coordinated system of
accessible, community-based respite care services for
family caregivers of children or adults with special
needs.
(7) Respite care.--The term ``respite care'' means
planned or emergency care provided to a child or adult
with a special need in order to provide temporary
relief to the family caregiver of that child or adult.
(8) State.--The term ``State'' means any of the
several States, the District of Columbia, the Virgin
Islands of the United States, the Commonwealth of
Puerto Rico, Guam, American Samoa, and the Commonwealth
of the Northern Mariana Islands.
SEC. 2902. [300II-1] LIFESPAN RESPITE CARE GRANTS AND COOPERATIVE
AGREEMENTS.
(a) Purposes.--The purposes of this section are--
(1) to expand and enhance respite care services to
family caregivers;
(2) to improve the statewide dissemination and
coordination of respite care; and
(3) to provide, supplement, or improve access and
quality of respite care services to family caregivers,
thereby reducing family caregiver strain.
(b) Authorization.--Subject to subsection (e), the
Secretary is authorized to award grants or cooperative
agreements for the purposes described in subsection (a) to
eligible State agencies for which an application is submitted
pursuant to subsection (d).
(c) Federal Lifespan Approach.--In carrying out this
section, the Secretary shall work in cooperation with the
National Family Caregiver Support Program of the Administration
on Aging and other respite care programs within the Department
of Health and Human Services to ensure coordination of respite
care services for family caregivers of children and adults with
special needs.
(d) Application.--
(1) Submission.--Each Governor desiring the
eligible State agency of his or her State to receive a
grant or cooperative agreement under this section shall
submit an application on behalf of such agency to the
Secretary at such time, in such manner, and containing
such information as the Secretary shall require.
(2) Contents.--Each application submitted under
this section shall include--
(A) a description of the eligible State
agency's--
(i) ability to work with other
State and community-based agencies;
(ii) understanding of respite care
and family caregiver issues across all
age groups, disabilities, and chronic
conditions; and
(iii) capacity to ensure meaningful
involvement of family members, family
caregivers, and care recipients;
(B) with respect to the population of
family caregivers to whom respite care
information or services will be provided or for
whom respite care workers and volunteers will
be recruited and trained, a description of--
(i) the population of family
caregivers;
(ii) the extent and nature of the
respite care needs of that population;
(iii) existing respite care
services for that population, including
numbers of family caregivers being
served and extent of unmet need;
(iv) existing methods or systems to
coordinate respite care information and
services to the population at the State
and local level and extent of unmet
need;
(v) how respite care information
dissemination and coordination, respite
care services, respite care worker and
volunteer recruitment and training
programs, or training programs for
family caregivers that assist such
family caregivers in making informed
decisions about respite care services
will be provided using grant or
cooperative agreement funds;
(vi) a plan for administration,
collaboration, and coordination of the
proposed respite care activities with
other related services or programs
offered by public or private, nonprofit
entities, including area agencies on
aging;
(vii) how the population, including
family caregivers, care recipients, and
relevant public or private agencies,
will participate in the planning and
implementation of the proposed respite
care activities;
(viii) how the proposed respite
care activities will make use, to the
maximum extent feasible, of other
Federal, State, and local funds,
programs, contributions, other forms of
reimbursements, personnel, and
facilities;
(ix) respite care services
available to family caregivers in the
eligible State agency's State or
locality, including unmet needs and how
the eligible State agency's plan for
use of funds will improve the
coordination and distribution of
respite care services for family
caregivers of children and adults with
special needs;
(x) the criteria used to identify
family caregivers eligible for respite
care services;
(xi) how the quality and safety of
any respite care services provided will
be monitored, including methods to
ensure that respite care workers and
volunteers are appropriately screened
and possess the necessary skills to
care for the needs of the care
recipient in the absence of the family
caregiver; and
(xii) the results expected from
proposed respite care activities and
the procedures to be used for
evaluating those results;
(C) assurances that, where appropriate, the
eligible State agency will have a system for
maintaining the confidentiality of care
recipient and family caregiver records; and
(D) a memorandum of agreement regarding the
joint responsibility for the eligible State
agency's lifespan respite program between--
(i) the eligible State agency; and
(ii) a public or private nonprofit
statewide respite coalition or
organization.
(e) Priority; Considerations.--When awarding grants or
cooperative agreements under this section, the Secretary
shall--
(1) give priority to eligible State agencies that
the Secretary determines show the greatest likelihood
of implementing or enhancing lifespan respite care
statewide; and
(2) give consideration to eligible State agencies
that are building or enhancing the capacity of their
long-term care systems to respond to the comprehensive
needs, including respite care needs, of their
residents.
(f) Use of Grant or Cooperative Agreement Funds.--
(1) In general.--
(A) Required uses of funds.--Each eligible
State agency awarded a grant or cooperative
agreement under this section shall use all or
part of the funds--
(i) to develop or enhance lifespan
respite care at the State and local
levels;
(ii) to provide respite care
services for family caregivers caring
for children or adults;
(iii) to train and recruit respite
care workers and volunteers;
(iv) to provide information to
caregivers about available respite and
support services; and
(v) to assist caregivers in gaining
access to such services.
(B) Optional uses of funds.--Each eligible
State agency awarded a grant or cooperative
agreement under this section may use part of
the funds for--
(i) training programs for family
caregivers to assist such family
caregivers in making informed decisions
about respite care services;
(ii) other services essential to
the provision of respite care as the
Secretary may specify; or
(iii) training and education for
new caregivers.
(2) Subcontracts.--Each eligible State agency
awarded a grant or cooperative agreement under this
section may carry out the activities described in
paragraph (1) directly or by grant to, or contract
with, public or private entities.
(3) Matching funds.--
(A) In general.--With respect to the costs
of the activities to be carried out under
paragraph (1), a condition for the receipt of a
grant or cooperative agreement under this
section is that the eligible State agency
agrees to make available (directly or through
donations from public or private entities) non-
Federal contributions toward such costs in an
amount that is not less than 25 percent of such
costs.
(B) Determination of amount contributed.--
Non-Federal contributions required by
subparagraph (A) may be in cash or in kind,
fairly evaluated, including plant, equipment,
or services. Amounts provided by the Federal
Government, or services assisted or subsidized
to any significant extent by the Federal
Government, may not be included in determining
the amount of such non-Federal contributions.
(g) Term of Grants or Cooperative Agreements.--
(1) In general.--The Secretary shall award grants
or cooperative agreements under this section for terms
that do not exceed 5 years.
(2) Renewal.--The Secretary may renew a grant or
cooperative agreement under this section at the end of
the term of the grant or cooperative agreement
determined under paragraph (1).
(h) Maintenance of Effort.--Funds made available under this
section shall be used to supplement and not supplant other
Federal, State, and local funds available for respite care
services.
SEC. 2903. [300II-2] NATIONAL LIFESPAN RESPITE RESOURCE CENTER.
(a) Establishment.--The Secretary may award a grant or
cooperative agreement to a public or private nonprofit entity
to establish a National Resource Center on Lifespan Respite
Care (referred to in this section as the ``center'').
(b) Purposes of the Center.--The center shall--
(1) maintain a national database on lifespan
respite care;
(2) provide training and technical assistance to
State, community, and nonprofit respite care programs;
and
(3) provide information, referral, and educational
programs to the public on lifespan respite care.
SEC. 2904. [300II-3] REPORT.
Not later than January 1, 2009, the Secretary shall report
to the Congress on the activities undertaken under this title.
Such report shall evaluate--
(1) the number of States that have lifespan respite
care programs;
(2) the demographics of the caregivers receiving
respite care services through grants or cooperative
agreements under this title; and
(3) the effectiveness of entities receiving grants
or cooperative agreements under this title.
SEC. 2905. [300II-4] AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated to carry out this
title--
(1) $30,000,000 for fiscal year 2007;
(2) $40,000,000 for fiscal year 2008;
(3) $53,330,000 for fiscal year 2009;
(4) $71,110,000 for fiscal year 2010; and
(5) $94,810,000 for fiscal year 2011.
TITLE XXX--HEALTH INFORMATION TECHNOLOGY AND QUALITY
SEC. 3000. [300JJ] DEFINITIONS.
In this title:
(1) Certified ehr technology.--The term ``certified
EHR technology'' means a qualified electronic health
record that is certified pursuant to section 3001(c)(5)
as meeting standards adopted under section 3004 that
are applicable to the type of record involved (as
determined by the Secretary, such as an ambulatory
electronic health record for office-based physicians or
an inpatient hospital electronic health record for
hospitals).
(2) Enterprise integration.--The term ``enterprise
integration'' means the electronic linkage of health
care providers, health plans, the government, and other
interested parties, to enable the electronic exchange
and use of health information among all the components
in the health care infrastructure in accordance with
applicable law, and such term includes related
application protocols and other related standards.
(3) Health care provider.--The term ``health care
provider'' includes a hospital, skilled nursing
facility, nursing facility, home health entity or other
long term care facility, health care clinic, community
mental health center (as defined in section
1913(b)(1)), renal dialysis facility, blood center,
ambulatory surgical center described in section 1833(i)
of the Social Security Act, emergency medical services
provider, Federally qualified health center, group
practice, a pharmacist, a pharmacy, a laboratory, a
physician (as defined in section 1861(r) of the Social
Security Act), a practitioner (as described in section
1842(b)(18)(C) of the Social Security Act), a provider
operated by, or under contract with, the Indian Health
Service or by an Indian tribe (as defined in the Indian
Self-Determination and Education Assistance Act),
tribal organization, or urban Indian organization (as
defined in section 4 of the Indian Health Care
Improvement Act), a rural health clinic, a covered
entity under section 340B, an ambulatory surgical
center described in section 1833(i) of the Social
Security Act, a therapist (as defined in section
1848(k)(3)(B)(iii) of the Social Security Act), and any
other category of health care facility, entity,
practitioner, or clinician determined appropriate by
the Secretary.
(4) Health information.--The term ``health
information'' has the meaning given such term in
section 1171(4) of the Social Security Act.
(5) Health information technology.--The term
``health information technology'' means hardware,
software, integrated technologies or related licenses,
intellectual property, upgrades, or packaged solutions
sold as services that are designed for or support the
use by health care entities or patients for the
electronic creation, maintenance, access, or exchange
of health information
(6) Health plan.--The term ``health plan'' has the
meaning given such term in section 1171(5) of the
Social Security Act.
(7) HIT policy committee.--The term ``HIT Policy
Committee'' means such Committee established under
section 3002(a).
(8) HIT standards committee.--The term ``HIT
Standards Committee'' means such Committee established
under section 3003(a).
(9) Individually identifiable health information.--
The term ``individually identifiable health
information'' has the meaning given such term in
section 1171(6) of the Social Security Act.
(10) Laboratory.--The term ``laboratory'' has the
meaning given such term in section 353(a).
(11) National coordinator.--The term ``National
Coordinator'' means the head of the Office of the
National Coordinator for Health Information Technology
established under section 3001(a).
(12) Pharmacist.--The term ``pharmacist'' has the
meaning given such term in section 804(2) of the
Federal Food, Drug, and Cosmetic Act.
(13) Qualified electronic health record.--The term
``qualified electronic health record'' means an
electronic record of health-related information on an
individual that--
(A) includes patient demographic and
clinical health information, such as medical
history and problem lists; and
(B) has the capacity--
(i) to provide clinical decision
support;
(ii) to support physician order
entry;
(iii) to capture and query
information relevant to health care
quality; and
(iv) to exchange electronic health
information with, and integrate such
information from other sources.
(14) State.--The term ``State'' means each of the
several States, the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa, and the
Northern Mariana Islands.
Subtitle A--Promotion of Health Information Technology
SEC. 3001. [300JJ-11] OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH
INFORMATION TECHNOLOGY.
(a) Establishment.--There is established within the
Department of Health and Human Services an Office of the
National Coordinator for Health Information Technology
(referred to in this section as the ``Office''). The Office
shall be headed by a National Coordinator who shall be
appointed by the Secretary and shall report directly to the
Secretary.
(b) Purpose.--The National Coordinator shall perform the
duties under subsection (c) in a manner consistent with the
development of a nationwide health information technology
infrastructure that allows for the electronic use and exchange
of information and that--
(1) ensures that each patient's health information
is secure and protected, in accordance with applicable
law;
(2) improves health care quality, reduces medical
errors, reduces health disparities, and advances the
delivery of patient-centered medical care;
(3) reduces health care costs resulting from
inefficiency, medical errors, inappropriate care,
duplicative care, and incomplete information;
(4) provides appropriate information to help guide
medical decisions at the time and place of care;
(5) ensures the inclusion of meaningful public
input in such development of such infrastructure;
(6) improves the coordination of care and
information among hospitals, laboratories, physician
offices, and other entities through an effective
infrastructure for the secure and authorized exchange
of health care information;
(7) improves public health activities and
facilitates the early identification and rapid response
to public health threats and emergencies, including
bioterror events and infectious disease outbreaks;
(8) facilitates health and clinical research and
health care quality;
(9) promotes early detection, prevention, and
management of chronic diseases;
(10) promotes a more effective marketplace, greater
competition, greater systems analysis, increased
consumer choice, and improved outcomes in health care
services; and
(11) improves efforts to reduce health disparities.
(c) Duties of the National Coordinator.--
(1) Standards.--The National Coordinator shall--
(A) review and determine whether to endorse
each standard, implementation specification,
and certification criterion for the electronic
exchange and use of health information that is
recommended by the HIT Standards Committee
under section 3003 for purposes of adoption
under section 3004;
(B) make such determinations under
subparagraph (A), and report to the Secretary
such determinations, not later than 45 days
after the date the recommendation is received
by the Coordinator; and
(C) review Federal health information
technology investments to ensure that Federal
health information technology programs are
meeting the objectives of the strategic plan
published under paragraph (3).
(2) HIT policy coordination.--
(A) In general.--The National Coordinator
shall coordinate health information technology
policy and programs of the Department with
those of other relevant executive branch
agencies with a goal of avoiding duplication of
efforts and of helping to ensure that each
agency undertakes health information technology
activities primarily within the areas of its
greatest expertise and technical capability and
in a manner towards a coordinated national
goal.
(B) HIT policy and standards committees.--
The National Coordinator shall be a leading
member in the establishment and operations of
the HIT Policy Committee and the HIT Standards
Committee and shall serve as a liaison among
those two Committees and the Federal
Government.
(3) Strategic plan.--
(A) In general.--The National Coordinator
shall, in consultation with other appropriate
Federal agencies (including the National
Institute of Standards and Technology), update
the Federal Health IT Strategic Plan (developed
as of June 3, 2008) to include specific
objectives, milestones, and metrics with
respect to the following:
(i) The electronic exchange and use
of health information and the
enterprise integration of such
information.
(ii) The utilization of an
electronic health record for each
person in the United States by 2014.
(iii) The incorporation of privacy
and security protections for the
electronic exchange of an individual's
individually identifiable health
information.
(iv) Ensuring security methods to
ensure appropriate authorization and
electronic authentication of health
information and specifying technologies
or methodologies for rendering health
information unusable, unreadable, or
indecipherable.
(v) Specifying a framework for
coordination and flow of
recommendations and policies under this
subtitle among the Secretary, the
National Coordinator, the HIT Policy
Committee, the HIT Standards Committee,
and other health information exchanges
and other relevant entities.
(vi) Methods to foster the public
understanding of health information
technology.
(vii) Strategies to enhance the use
of health information technology in
improving the quality of health care,
reducing medical errors, reducing
health disparities, improving public
health, increasing prevention and
coordination with community resources,
and improving the continuity of care
among health care settings.
(viii) Specific plans for ensuring
that populations with unique needs,
such as children, are appropriately
addressed in the technology design, as
appropriate, which may include
technology that automates enrollment
and retention for eligible individuals.
(B) Collaboration.--The strategic plan
shall be updated through collaboration of
public and private entities.
(C) Measurable outcome goals.--The
strategic plan update shall include measurable
outcome goals.
(D) Publication.--The National Coordinator
shall republish the strategic plan, including
all updates.
(4) Website.--The National Coordinator shall
maintain and frequently update an Internet website on
which there is posted information on the work,
schedules, reports, recommendations, and other
information to ensure transparency in promotion of a
nationwide health information technology
infrastructure.
(5) Certification.--
(A) In general.--The National Coordinator,
in consultation with the Director of the
National Institute of Standards and Technology,
shall keep or recognize a program or programs
for the voluntary certification of health
information technology as being in compliance
with applicable certification criteria adopted
under this subtitle. Such program shall
include, as appropriate, testing of the
technology in accordance with section 13201(b)
of the Health Information Technology for
Economic and Clinical Health Act.
(B) Certification criteria described.--In
this title, the term ``certification criteria''
means, with respect to standards and
implementation specifications for health
information technology, criteria to establish
that the technology meets such standards and
implementation specifications.
(6) Reports and publications.--
(A) Report on additional funding or
authority needed.--Not later than 12 months
after the date of the enactment of this title,
the National Coordinator shall submit to the
appropriate committees of jurisdiction of the
House of Representatives and the Senate a
report on any additional funding or authority
the Coordinator or the HIT Policy Committee or
HIT Standards Committee requires to evaluate
and develop standards, implementation
specifications, and certification criteria, or
to achieve full participation of stakeholders
in the adoption of a nationwide health
information technology infrastructure that
allows for the electronic use and exchange of
health information.
(B) Implementation report.--The National
Coordinator shall prepare a report that
identifies lessons learned from major public
and private health care systems in their
implementation of health information
technology, including information on whether
the technologies and practices developed by
such systems may be applicable to and usable in
whole or in part by other health care
providers.
(C) Assessment of impact of hit on
communities with health disparities and
uninsured, underinsured, and medically
underserved areas.--The National Coordinator
shall assess and publish the impact of health
information technology in communities with
health disparities and in areas with a high
proportion of individuals who are uninsured,
underinsured, and medically underserved
individuals (including urban and rural areas)
and identify practices to increase the adoption
of such technology by health care providers in
such communities, and the use of health
information technology to reduce and better
manage chronic diseases.
(D) Evaluation of benefits and costs of the
electronic use and exchange of health
information.--The National Coordinator shall
evaluate and publish evidence on the benefits
and costs of the electronic use and exchange of
health information and assess to whom these
benefits and costs accrue.
(E) Resource requirements.--The National
Coordinator shall estimate and publish
resources required annually to reach the goal
of utilization of an electronic health record
for each person in the United States by 2014,
including--
(i) the required level of Federal
funding;
(ii) expectations for regional,
State, and private investment;
(iii) the expected contributions by
volunteers to activities for the
utilization of such records; and
(iv) the resources needed to
establish a health information
technology workforce sufficient to
support this effort (including
education programs in medical
informatics and health information
management).
(7) Assistance.--The National Coordinator may
provide financial assistance to consumer advocacy
groups and not-for-profit entities that work in the
public interest for purposes of defraying the cost to
such groups and entities to participate under, whether
in whole or in part, the National Technology Transfer
Act of 1995 (15 U.S.C. 272 note).
(8) Governance for nationwide health information
network.--The National Coordinator shall establish a
governance mechanism for the nationwide health
information network.
(d) Detail of Federal Employees.--
(1) In general.--Upon the request of the National
Coordinator, the head of any Federal agency is
authorized to detail, with or without reimbursement
from the Office, any of the personnel of such agency to
the Office to assist it in carrying out its duties
under this section.
(2) Effect of detail.--Any detail of personnel
under paragraph (1) shall--
(A) not interrupt or otherwise affect the
civil service status or privileges of the
Federal employee; and
(B) be in addition to any other staff of
the Department employed by the National
Coordinator.
(3) Acceptance of detailees.--Notwithstanding any
other provision of law, the Office may accept detailed
personnel from other Federal agencies without regard to
whether the agency described under paragraph (1) is
reimbursed.
(e) Chief Privacy Officer of the Office of the National
Coordinator.--Not later than 12 months after the date of the
enactment of this title, the Secretary shall appoint a Chief
Privacy Officer of the Office of the National Coordinator,
whose duty it shall be to advise the National Coordinator on
privacy, security, and data stewardship of electronic health
information and to coordinate with other Federal agencies (and
similar privacy officers in such agencies), with State and
regional efforts, and with foreign countries with regard to the
privacy, security, and data stewardship of electronic
individually identifiable health information.
SEC. 3002. [300JJ-12] HIT POLICY COMMITTEE.
(a) Establishment.--There is established a HIT Policy
Committee to make policy recommendations to the National
Coordinator relating to the implementation of a nationwide
health information technology infrastructure, including
implementation of the strategic plan described in section
3001(c)(3).
(b) Duties.--
(1) Recommendations on health information
technology infrastructure.--The HIT Policy Committee
shall recommend a policy framework for the development
and adoption of a nationwide health information
technology infrastructure that permits the electronic
exchange and use of health information as is consistent
with the strategic plan under section 3001(c)(3) and
that includes the recommendations under paragraph (2).
The Committee shall update such recommendations and
make new recommendations as appropriate.
(2) Specific areas of standard development.--
(A) In general.--The HIT Policy Committee
shall recommend the areas in which standards,
implementation specifications, and
certification criteria are needed for the
electronic exchange and use of health
information for purposes of adoption under
section 3004 and shall recommend an order of
priority for the development, harmonization,
and recognition of such standards,
specifications, and certification criteria
among the areas so recommended. Such standards
and implementation specifications shall include
named standards, architectures, and software
schemes for the authentication and security of
individually identifiable health information
and other information as needed to ensure the
reproducible development of common solutions
across disparate entities.
(B) Areas required for consideration.--For
purposes of subparagraph (A), the HIT Policy
Committee shall make recommendations for at
least the following areas:
(i) Technologies that protect the
privacy of health information and
promote security in a qualified
electronic health record, including for
the segmentation and protection from
disclosure of specific and sensitive
individually identifiable health
information with the goal of minimizing
the reluctance of patients to seek care
(or disclose information about a
condition) because of privacy concerns,
in accordance with applicable law, and
for the use and disclosure of limited
data sets of such information.
(ii) A nationwide health
information technology infrastructure
that allows for the electronic use and
accurate exchange of health
information.
(iii) The utilization of a
certified electronic health record for
each person in the United States by
2014.
(iv) Technologies that as a part of
a qualified electronic health record
allow for an accounting of disclosures
made by a covered entity (as defined
for purposes of regulations promulgated
under section 264(c) of the Health
Insurance Portability and
Accountability Act of 1996) for
purposes of treatment, payment, and
health care operations (as such terms
are defined for purposes of such
regulations).
(v) The use of certified electronic
health records to improve the quality
of health care, such as by promoting
the coordination of health care and
improving continuity of health care
among health care providers, by
reducing medical errors, by improving
population health, by reducing health
disparities, by reducing chronic
disease, and by advancing research and
education.
(vi) Technologies that allow
individually identifiable health
information to be rendered unusable,
unreadable, or indecipherable to
unauthorized individuals when such
information is transmitted in the
nationwide health information network
or physically transported outside of
the secured, physical perimeter of a
health care provider, health plan, or
health care clearinghouse.
(vii) The use of electronic systems
to ensure the comprehensive collection
of patient demographic data, including,
at a minimum, race, ethnicity, primary
language, and gender information.
(viii) Technologies that address
the needs of children and other
vulnerable populations.
(C) Other areas for consideration.--In
making recommendations under subparagraph (A),
the HIT Policy Committee may consider the
following additional areas:
(i) The appropriate uses of a
nationwide health information
infrastructure, including for purposes
of--
(I) the collection of
quality data and public
reporting;
(II) biosurveillance and
public health;
(III) medical and clinical
research; and
(IV) drug safety.
(ii) Self-service technologies that
facilitate the use and exchange of
patient information and reduce wait
times.
(iii) Telemedicine technologies, in
order to reduce travel requirements for
patients in remote areas.
(iv) Technologies that facilitate
home health care and the monitoring of
patients recuperating at home.
(v) Technologies that help reduce
medical errors.
(vi) Technologies that facilitate
the continuity of care among health
settings.
(vii) Technologies that meet the
needs of diverse populations.
(viii) Methods to facilitate secure
access by an individual to such
individual's protected health
information.
(ix) Methods, guidelines, and
safeguards to facilitate secure access
to patient information by a family
member, caregiver, or guardian acting
on behalf of a patient due to age-
related and other disability, cognitive
impairment, or dementia.
(x) Any other technology that the
HIT Policy Committee finds to be among
the technologies with the greatest
potential to improve the quality and
efficiency of health care.
(3) Forum.--The HIT Policy Committee shall serve as
a forum for broad stakeholder input with specific
expertise in policies relating to the matters described
in paragraphs (1) and (2).
(4) Consistency with evaluation conducted under
mippa.--
(A) Requirement for consistency.--The HIT
Policy Committee shall ensure that
recommendations made under paragraph (2)(B)(vi)
are consistent with the evaluation conducted
under section 1809(a) of the Social Security
Act.
(B) Scope.--Nothing in subparagraph (A)
shall be construed to limit the recommendations
under paragraph (2)(B)(vi) to the elements
described in section 1809(a)(3) of the Social
Security Act.
(C) Timing.--The requirement under
subparagraph (A) shall be applicable to the
extent that evaluations have been conducted
under section 1809(a) of the Social Security
Act, regardless of whether the report described
in subsection (b) of such section has been
submitted.
(c) Membership and Operations.--
(1) In general.--The National Coordinator shall
take a leading position in the establishment and
operations of the HIT Policy Committee.
(2) Membership.--The HIT Policy Committee shall be
composed of members to be appointed as follows:
(A) 3 members shall be appointed by the
Secretary, 1 of whom shall be appointed to
represent the Department of Health and Human
Services and 1 of whom shall be a public health
official.
(B) 1 member shall be appointed by the
majority leader of the Senate.
(C) 1 member shall be appointed by the
minority leader of the Senate.
(D) 1 member shall be appointed by the
Speaker of the House of Representatives.
(E) 1 member shall be appointed by the
minority leader of the House of
Representatives.
(F) Such other members as shall be
appointed by the President as representatives
of other relevant Federal agencies.
(G) 13 members shall be appointed by the
Comptroller General of the United States of
whom--
(i) 3 members shall advocates for
patients or consumers;
(ii) 2 members shall represent
health care providers, one of which
shall be a physician;
(iii) 1 member shall be from a
labor organization representing health
care workers;
(iv) 1 member shall have expertise
in health information privacy and
security;
(v) 1 member shall have expertise
in improving the health of vulnerable
populations;
(vi) 1 member shall be from the
research community;
(vii) 1 member shall represent
health plans or other third-party
payers;
(viii) 1 member shall represent
information technology vendors;
(ix) 1 member shall represent
purchasers or employers; and
(x) 1 member shall have expertise
in health care quality measurement and
reporting.
(3) Participation.--The members of the HIT Policy
Committee appointed under paragraph (2) shall represent
a balance among various sectors of the health care
system so that no single sector unduly influences the
recommendations of the Policy Committee.
(4) Terms.--
(A) In general.--The terms of the members
of the HIT Policy Committee shall be for 3
years, except that the Comptroller General
shall designate staggered terms for the members
first appointed.
(B) Vacancies.--Any member appointed to
fill a vacancy in the membership of the HIT
Policy Committee that occurs prior to the
expiration of the term for which the member's
predecessor was appointed shall be appointed
only for the remainder of that term. A member
may serve after the expiration of that member's
term until a successor has been appointed. A
vacancy in the HIT Policy Committee shall be
filled in the manner in which the original
appointment was made.
(5) Outside involvement.--The HIT Policy Committee
shall ensure an opportunity for the participation in
activities of the Committee of outside advisors,
including individuals with expertise in the development
of policies for the electronic exchange and use of
health information, including in the areas of health
information privacy and security.
(6) Quorum.--A majority of the member of the HIT
Policy Committee shall constitute a quorum for purposes
of voting, but a lesser number of members may meet and
hold hearings.
(7) Failure of initial appointment.--If, on the
date that is 45 days after the date of enactment of
this title, an official authorized under paragraph (2)
to appoint one or more members of the HIT Policy
Committee has not appointed the full number of members
that such paragraph authorizes such official to
appoint, the Secretary is authorized to appoint such
members.
(8) Consideration.--The National Coordinator shall
ensure that the relevant and available recommendations
and comments from the National Committee on Vital and
Health Statistics are considered in the development of
policies.
(d) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.), other than section 14 of such Act, shall
apply to the HIT Policy Committee.
(e) Publication.--The Secretary shall provide for
publication in the Federal Register and the posting on the
Internet website of the Office of the National Coordinator for
Health Information Technology of all policy recommendations
made by the HIT Policy Committee under this section.
SEC. 3003. [300JJ-13] HIT STANDARDS COMMITTEE.
(a) Establishment.--There is established a committee to be
known as the HIT Standards Committee to recommend to the
National Coordinator standards, implementation specifications,
and certification criteria for the electronic exchange and use
of health information for purposes of adoption under section
3004, consistent with the implementation of the strategic plan
described in section 3001(c)(3) and beginning with the areas
listed in section 3002(b)(2)(B) in accordance with policies
developed by the HIT Policy Committee.
(b) Duties.--
(1) Standards development.--
(A) In general.--The HIT Standards
Committee shall recommend to the National
Coordinator standards, implementation
specifications, and certification criteria
described in subsection (a) that have been
developed, harmonized, or recognized by the HIT
Standards Committee. The HIT Standards
Committee shall update such recommendations and
make new recommendations as appropriate,
including in response to a notification sent
under section 3004(a)(2)(B). Such
recommendations shall be consistent with the
latest recommendations made by the HIT Policy
Committee.
(B) Harmonization.--The HIT Standards
Committee recognize harmonized or updated
standards from an entity or entities for the
purpose of harmonizing or updating standards
and implementation specifications in order to
achieve uniform and consistent implementation
of the standards and implementation
specifications.
(C) Pilot testing of standards and
implementation specifications.--In the
development, harmonization, or recognition of
standards and implementation specifications,
the HIT Standards Committee shall, as
appropriate, provide for the testing of such
standards and specifications by the National
Institute for Standards and Technology under
section 13201(a) of the Health Information
Technology for Economic and Clinical Health
Act.
(D) Consistency.--The standards,
implementation specifications, and
certification criteria recommended under this
subsection shall be consistent with the
standards for information transactions and data
elements adopted pursuant to section 1173 of
the Social Security Act.
(2) Forum.--The HIT Standards Committee shall serve
as a forum for the participation of a broad range of
stakeholders to provide input on the development,
harmonization, and recognition of standards,
implementation specifications, and certification
criteria necessary for the development and adoption of
a nationwide health information technology
infrastructure that allows for the electronic use and
exchange of health information.
(3) Schedule.--Not later than 90 days after the
date of the enactment of this title, the HIT Standards
Committee shall develop a schedule for the assessment
of policy recommendations developed by the HIT Policy
Committee under section 3002. The HIT Standards
Committee shall update such schedule annually. The
Secretary shall publish such schedule in the Federal
Register.
(4) Public input.--The HIT Standards Committee
shall conduct open public meetings and develop a
process to allow for public comment on the schedule
described in paragraph (3) and recommendations
described in this subsection. Under such process
comments shall be submitted in a timely manner after
the date of publication of a recommendation under this
subsection.
(5) Consideration.--The National Coordinator shall
ensure that the relevant and available recommendations
and comments from the National Committee on Vital and
Health Statistics are considered in the development of
standards.
(c) Membership and Operations.--
(1) In general.--The National Coordinator shall
take a leading position in the establishment and
operations of the HIT Standards Committee.
(2) Membership.--The membership of the HIT
Standards Committee shall at least reflect providers,
ancillary healthcare workers, consumers, purchasers,
health plans, technology vendors, researchers, relevant
Federal agencies, and individuals with technical
expertise on health care quality, privacy and security,
and on the electronic exchange and use of health
information.
(3) Participation.--The members of the HIT
Standards Committee appointed under this subsection
shall represent a balance among various sectors of the
health care system so that no single sector unduly
influences the recommendations of such Committee.
(4) Outside involvement.--The HIT Policy Committee
shall ensure an opportunity for the participation in
activities of the Committee of outside advisors,
including individuals with expertise in the development
of standards for the electronic exchange and use of
health information, including in the areas of health
information privacy and security.
(5) Balance among sectors.--In developing the
procedures for conducting the activities of the HIT
Standards Committee, the HIT Standards Committee shall
act to ensure a balance among various sectors of the
health care system so that no single sector unduly
influences the actions of the HIT Standards Committee.
(6) Assistance.--For the purposes of carrying out
this section, the Secretary may provide or ensure that
financial assistance is provided by the HIT Standards
Committee to defray in whole or in part any membership
fees or dues charged by such Committee to those
consumer advocacy groups and not for profit entities
that work in the public interest as a part of their
mission.
(d) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.), other than section 14, shall apply to the
HIT Standards Committee.
(e) Publication.--The Secretary shall provide for
publication in the Federal Register and the posting on the
Internet website of the Office of the National Coordinator for
Health Information Technology of all recommendations made by
the HIT Standards Committee under this section.
SEC. 3004. [300JJ-14] PROCESS FOR ADOPTION OF ENDORSED RECOMMENDATIONS;
ADOPTION OF INITIAL SET OF STANDARDS,
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION
CRITERIA.
(a) Process for Adoption of Endorsed Recommendations.--
(1) Review of endorsed standards, implementation
specifications, and certification criteria.--Not later
than 90 days after the date of receipt of standards,
implementation specifications, or certification
criteria endorsed under section 3001(c), the Secretary,
in consultation with representatives of other relevant
Federal agencies, shall jointly review such standards,
implementation specifications, or certification
criteria and shall determine whether or not to propose
adoption of such standards, implementation
specifications, or certification criteria.
(2) Determination to adopt standards,
implementation specifications, and certification
criteria.--If the Secretary determines--
(A) to propose adoption of any grouping of
such standards, implementation specifications,
or certification criteria, the Secretary shall,
by regulation under section 553 of title 5,
United States Code, determine whether or not to
adopt such grouping of standards,
implementation specifications, or certification
criteria; or
(B) not to propose adoption of any grouping
of standards, implementation specifications, or
certification criteria, the Secretary shall
notify the National Coordinator and the HIT
Standards Committee in writing of such
determination and the reasons for not proposing
the adoption of such recommendation.
(3) Publication.--The Secretary shall provide for
publication in the Federal Register of all
determinations made by the Secretary under paragraph
(1).
(b) Adoption of Standards, Implementation Specifications,
and Certification Criteria.--
(1) In general.--Not later than December 31, 2009,
the Secretary shall, through the rulemaking process
consistent with subsection (a)(2)(A), adopt an initial
set of standards, implementation specifications, and
certification criteria for the areas required for
consideration under section 3002(b)(2)(B). The
rulemaking for the initial set of standards,
implementation specifications, and certification
criteria may be issued on an interim, final basis.
(2) Application of current standards,
implementation specifications, and certification
criteria.--The standards, implementation
specifications, and certification criteria adopted
before the date of the enactment of this title through
the process existing through the Office of the National
Coordinator for Health Information Technology may be
applied towards meeting the requirement of paragraph
(1).
(3) Subsequent standards activity.--The Secretary
shall adopt additional standards, implementation
specifications, and certification criteria as necessary
and consistent with the schedule published under
section 3003(b)(2).
SEC. 3005. [300JJ-15] APPLICATION AND USE OF ADOPTED STANDARDS AND
IMPLEMENTATION SPECIFICATIONS BY FEDERAL AGENCIES.
For requirements relating to the application and use by
Federal agencies of the standards and implementation
specifications adopted under section 3004, see section 13111 of
the Health Information Technology for Economic and Clinical
Health Act.
SEC. 3006. [300JJ-16] VOLUNTARY APPLICATION AND USE OF ADOPTED
STANDARDS AND IMPLEMENTATION SPECIFICATIONS BY
PRIVATE ENTITIES.
(a) In General.--Except as provided under section 13112 of
the HITECH Act, nothing in such Act or in the amendments made
by such Act shall be construed--
(1) to require a private entity to adopt or comply
with a standard or implementation specification adopted
under section 3004; or
(2) to provide a Federal agency authority, other
than the authority such agency may have under other
provisions of law, to require a private entity to
comply with such a standard or implementation
specification.
(b) Rule of Construction.--Nothing in this subtitle shall
be construed to require that a private entity that enters into
a contract with the Federal Government apply or use the
standards and implementation specifications adopted under
section 3004 with respect to activities not related to the
contract.
SEC. 3007. [300JJ-17] FEDERAL HEALTH INFORMATION TECHNOLOGY.
(a) In General.--The National Coordinator shall support the
development and routine updating of qualified electronic health
record technology (as defined in section 3000) consistent with
subsections (b) and (c) and make available such qualified
electronic health record technology unless the Secretary
determines through an assessment that the needs and demands of
providers are being substantially and adequately met through
the marketplace.
(b) Certification.--In making such electronic health record
technology publicly available, the National Coordinator shall
ensure that the qualified electronic health record technology
described in subsection (a) is certified under the program
developed under section 3001(c)(3) to be in compliance with
applicable standards adopted under section 3003(a).
(c) Authorization To Charge a Nominal Fee.--The National
Coordinator may impose a nominal fee for the adoption by a
health care provider of the health information technology
system developed or approved under subsection (a) and (b). Such
fee shall take into account the financial circumstances of
smaller providers, low income providers, and providers located
in rural or other medically underserved areas.
(d) Rule of Construction.--Nothing in this section shall be
construed to require that a private or government entity adopt
or use the technology provided under this section.
SEC. 3008. [300JJ-18] TRANSITIONS.
(a) ONCHIT.--To the extent consistent with section 3001,
all functions, personnel, assets, liabilities, and
administrative actions applicable to the National Coordinator
for Health Information Technology appointed under Executive
Order No. 13335 or the Office of such National Coordinator on
the date before the date of the enactment of this title shall
be transferred to the National Coordinator appointed under
section 3001(a) and the Office of such National Coordinator as
of the date of the enactment of this title.
(b) National EHealth Collaborative.--Nothing in sections
3002 or 3003 or this subsection shall be construed as
prohibiting the AHIC Successor, Inc. doing business as the
National eHealth Collaborative from modifying its charter,
duties, membership, and any other structure or function
required to be consistent with section 3002 and 3003 so as to
allow the Secretary to recognize such AHIC Successor, Inc. as
the HIT Policy Committee or the HIT Standards Committee.
(c) Consistency of Recommendations.--In carrying out
section 3003(b)(1)(A), until recommendations are made by the
HIT Policy Committee, recommendations of the HIT Standards
Committee shall be consistent with the most recent
recommendations made by such AHIC Successor, Inc.
SEC. 3009. [300JJ-19] MISCELLANEOUS PROVISIONS.
(a) Relation to HIPAA Privacy and Security Law.--
(1) In general.--With respect to the relation of
this title to HIPAA privacy and security law:
(A) This title may not be construed as
having any effect on the authorities of the
Secretary under HIPAA privacy and security law.
(B) The purposes of this title include
ensuring that the health information technology
standards and implementation specifications
adopted under section 3004 take into account
the requirements of HIPAA privacy and security
law.
(2) Definition.--For purposes of this section, the
term ``HIPAA privacy and security law'' means--
(A) the provisions of part C of title XI of
the Social Security Act, section 264 of the
Health Insurance Portability and Accountability
Act of 1996, and subtitle D of title IV of the
Health Information Technology for Economic and
Clinical Health Act; and
(B) regulations under such provisions.
(b) Flexibility.--In administering the provisions of this
title, the Secretary shall have flexibility in applying the
definition of health care provider under section 3000(3),
including the authority to omit certain entities listed in such
definition when applying such definition under this title,
where appropriate.
Subtitle B--Incentives for the Use of Health Information Technology
SEC. 3011. [300JJ-31] IMMEDIATE FUNDING TO STRENGTHEN THE HEALTH
INFORMATION TECHNOLOGY INFRASTRUCTURE.
(a) In General.--The Secretary shall, using amounts
appropriated under section 3018, invest in the infrastructure
necessary to allow for and promote the electronic exchange and
use of health information for each individual in the United
States consistent with the goals outlined in the strategic plan
developed by the National Coordinator (and as available) under
section 3001. The Secretary shall invest funds through the
different agencies with expertise in such goals, such as the
Office of the National Coordinator for Health Information
Technology, the Health Resources and Services Administration,
the Agency for Healthcare Research and Quality, the Centers of
Medicare & Medicaid Services, the Centers for Disease Control
and Prevention, and the Indian Health Service to support the
following:
(1) Health information technology architecture that
will support the nationwide electronic exchange and use
of health information in a secure, private, and
accurate manner, including connecting health
information exchanges, and which may include updating
and implementing the infrastructure necessary within
different agencies of the Department of Health and
Human Services to support the electronic use and
exchange of health information.
(2) Development and adoption of appropriate
certified electronic health records for categories of
health care providers not eligible for support under
title XVIII or XIX of the Social Security Act for the
adoption of such records.
(3) Training on and dissemination of information on
best practices to integrate health information
technology, including electronic health records, into a
provider's delivery of care, consistent with best
practices learned from the Health Information
Technology Research Center developed under section
3012(b), including community health centers receiving
assistance under section 330, covered entities under
section 340B, and providers participating in one or
more of the programs under titles XVIII, XIX, and XXI
of the Social Security Act (relating to Medicare,
Medicaid, and the State Children's Health Insurance
Program).
(4) Infrastructure and tools for the promotion of
telemedicine, including coordination among Federal
agencies in the promotion of telemedicine.
(5) Promotion of the interoperability of clinical
data repositories or registries.
(6) Promotion of technologies and best practices
that enhance the protection of health information by
all holders of individually identifiable health
information.
(7) Improvement and expansion of the use of health
information technology by public health departments.
(b) Coordination.--The Secretary shall ensure funds under
this section are used in a coordinated manner with other health
information promotion activities.
(c) Additional Use of Funds.--In addition to using funds as
provided in subsection (a), the Secretary may use amounts
appropriated under section 3018 to carry out health information
technology activities that are provided for under laws in
effect on the date of the enactment of this title.
(d) Standards for Acquisition of Health Information
Technology.--To the greatest extent practicable, the Secretary
shall ensure that where funds are expended under this section
for the acquisition of health information technology, such
funds shall be used to acquire health information technology
that meets applicable standards adopted under section 3004.
Where it is not practicable to expend funds on health
information technology that meets such applicable standards,
the Secretary shall ensure that such health information
technology meets applicable standards otherwise adopted by the
Secretary.
SEC. 3012. [300JJ-32] HEALTH INFORMATION TECHNOLOGY IMPLEMENTATION
ASSISTANCE.
(a) Health Information Technology Extension Program.--To
assist health care providers to adopt, implement, and
effectively use certified EHR technology that allows for the
electronic exchange and use of health information, the
Secretary, acting through the Office of the National
Coordinator, shall establish a health information technology
extension program to provide health information technology
assistance services to be carried out through the Department of
Health and Human Services. The National Coordinator shall
consult with other Federal agencies with demonstrated
experience and expertise in information technology services,
such as the National Institute of Standards and Technology, in
developing and implementing this program.
(b) Health Information Technology Research Center.--
(1) In general.--The Secretary shall create a
Health Information Technology Research Center (in this
section referred to as the ``Center'') to provide
technical assistance and develop or recognize best
practices to support and accelerate efforts to adopt,
implement, and effectively utilize health information
technology that allows for the electronic exchange and
use of information in compliance with standards,
implementation specifications, and certification
criteria adopted under section 3004.
(2) Input.--The Center shall incorporate input
from--
(A) other Federal agencies with
demonstrated experience and expertise in
information technology services such as the
National Institute of Standards and Technology;
(B) users of health information technology,
such as providers and their support and
clerical staff and others involved in the care
and care coordination of patients, from the
health care and health information technology
industry; and
(C) others as appropriate.
(3) Purposes.--The purposes of the Center are to--
(A) provide a forum for the exchange of
knowledge and experience;
(B) accelerate the transfer of lessons
learned from existing public and private sector
initiatives, including those currently
receiving Federal financial support;
(C) assemble, analyze, and widely
disseminate evidence and experience related to
the adoption, implementation, and effective use
of health information technology that allows
for the electronic exchange and use of
information including through the regional
centers described in subsection (c);
(D) provide technical assistance for the
establishment and evaluation of regional and
local health information networks to facilitate
the electronic exchange of information across
health care settings and improve the quality of
health care;
(E) provide technical assistance for the
development and dissemination of solutions to
barriers to the exchange of electronic health
information; and
(F) learn about effective strategies to
adopt and utilize health information technology
in medically underserved communities.
(c) Health Information Technology Regional Extension
Centers.--
(1) In general.--The Secretary shall provide
assistance for the creation and support of regional
centers (in this subsection referred to as ``regional
centers'') to provide technical assistance and
disseminate best practices and other information
learned from the Center to support and accelerate
efforts to adopt, implement, and effectively utilize
health information technology that allows for the
electronic exchange and use of information in
compliance with standards, implementation
specifications, and certification criteria adopted
under section 3004. Activities conducted under this
subsection shall be consistent with the strategic plan
developed by the National Coordinator, (and, as
available) under section 3001.
(2) Affiliation.--Regional centers shall be
affiliated with any United States-based nonprofit
institution or organization, or group thereof, that
applies and is awarded financial assistance under this
section. Individual awards shall be decided on the
basis of merit.
(3) Objective.--The objective of the regional
centers is to enhance and promote the adoption of
health information technology through--
(A) assistance with the implementation,
effective use, upgrading, and ongoing
maintenance of health information technology,
including electronic health records, to
healthcare providers nationwide;
(B) broad participation of individuals from
industry, universities, and State governments;
(C) active dissemination of best practices
and research on the implementation, effective
use, upgrading, and ongoing maintenance of
health information technology, including
electronic health records, to health care
providers in order to improve the quality of
healthcare and protect the privacy and security
of health information;
(D) participation, to the extent
practicable, in health information exchanges;
(E) utilization, when appropriate, of the
expertise and capability that exists in Federal
agencies other than the Department; and
(F) integration of health information
technology, including electronic health
records, into the initial and ongoing training
of health professionals and others in the
healthcare industry that would be instrumental
to improving the quality of healthcare through
the smooth and accurate electronic use and
exchange of health information.
(4) Regional assistance.--Each regional center
shall aim to provide assistance and education to all
providers in a region, but shall prioritize any direct
assistance first to the following:
(A) Public or not-for-profit hospitals or
critical access hospitals.
(B) Federally qualified health centers (as
defined in section 1861(aa)(4) of the Social
Security Act).
(C) Entities that are located in rural and
other areas that serve uninsured, underinsured,
and medically underserved individuals
(regardless of whether such area is urban or
rural).
(D) Individual or small group practices (or
a consortium thereof) that are primarily
focused on primary care.
(5) Financial support.--The Secretary may provide
financial support to any regional center created under
this subsection for a period not to exceed four years.
The Secretary may not provide more than 50 percent of
the capital and annual operating and maintenance funds
required to create and maintain such a center, except
in an instance of national economic conditions which
would render this cost-share requirement detrimental to
the program and upon notification to Congress as to the
justification to waive the cost-share requirement.
(6) Notice of program description and availability
of funds.--The Secretary shall publish in the Federal
Register, not later than 90 days after the date of the
enactment of this title, a draft description of the
program for establishing regional centers under this
subsection. Such description shall include the
following:
(A) A detailed explanation of the program
and the programs goals.
(B) Procedures to be followed by the
applicants.
(C) Criteria for determining qualified
applicants.
(D) Maximum support levels expected to be
available to centers under the program.
(7) Application review.--The Secretary shall
subject each application under this subsection to merit
review. In making a decision whether to approve such
application and provide financial support, the
Secretary shall consider at a minimum the merits of the
application, including those portions of the
application regarding--
(A) the ability of the applicant to provide
assistance under this subsection and
utilization of health information technology
appropriate to the needs of particular
categories of health care providers;
(B) the types of service to be provided to
health care providers;
(C) geographical diversity and extent of
service area; and
(D) the percentage of funding and amount of
in-kind commitment from other sources.
(8) Biennial evaluation.--Each regional center
which receives financial assistance under this
subsection shall be evaluated biennially by an
evaluation panel appointed by the Secretary. Each
evaluation panel shall be composed of private experts,
none of whom shall be connected with the center
involved, and of Federal officials. Each evaluation
panel shall measure the involved center's performance
against the objective specified in paragraph (3). The
Secretary shall not continue to provide funding to a
regional center unless its evaluation is overall
positive.
(9) Continuing support.--After the second year of
assistance under this subsection, a regional center may
receive additional support under this subsection if it
has received positive evaluations and a finding by the
Secretary that continuation of Federal funding to the
center was in the best interest of provision of health
information technology extension services.
SEC. 3013. [300JJ-33] STATE GRANTS TO PROMOTE HEALTH INFORMATION
TECHNOLOGY.
(a) In General.--The Secretary, acting through the National
Coordinator, shall establish a program in accordance with this
section to facilitate and expand the electronic movement and
use of health information among organizations according to
nationally recognized standards.
(b) Planning Grants.--The Secretary may award a grant to a
State or qualified State-designated entity (as described in
subsection (f)) that submits an application to the Secretary at
such time, in such manner, and containing such information as
the Secretary may specify, for the purpose of planning
activities described in subsection (d).
(c) Implementation Grants.--The Secretary may award a grant
to a State or qualified State designated entity that--
(1) has submitted, and the Secretary has approved,
a plan described in subsection (e) (regardless of
whether such plan was prepared using amounts awarded
under subsection (b); and
(2) submits an application at such time, in such
manner, and containing such information as the
Secretary may specify.
(d) Use of Funds.--Amounts received under a grant under
subsection (c) shall be used to conduct activities to
facilitate and expand the electronic movement and use of health
information among organizations according to nationally
recognized standards through activities that include--
(1) enhancing broad and varied participation in the
authorized and secure nationwide electronic use and
exchange of health information;
(2) identifying State or local resources available
towards a nationwide effort to promote health
information technology;
(3) complementing other Federal grants, programs,
and efforts towards the promotion of health information
technology;
(4) providing technical assistance for the
development and dissemination of solutions to barriers
to the exchange of electronic health information;
(5) promoting effective strategies to adopt and
utilize health information technology in medically
underserved communities;
(6) assisting patients in utilizing health
information technology;
(7) encouraging clinicians to work with Health
Information Technology Regional Extension Centers as
described in section 3012, to the extent they are
available and valuable;
(8) supporting public health agencies' authorized
use of and access to electronic health information;
(9) promoting the use of electronic health records
for quality improvement including through quality
measures reporting; and
(10) such other activities as the Secretary may
specify.
(e) Plan.--
(1) In general.--A plan described in this
subsection is a plan that describes the activities to
be carried out by a State or by the qualified State-
designated entity within such State to facilitate and
expand the electronic movement and use of health
information among organizations according to nationally
recognized standards and implementation specifications.
(2) Required elements.--A plan described in
paragraph (1) shall--
(A) be pursued in the public interest;
(B) be consistent with the strategic plan
developed by the National Coordinator, (and, as
available) under section 3001;
(C) include a description of the ways the
State or qualified State-designated entity will
carry out the activities described in
subsection (b); and
(D) contain such elements as the Secretary
may require.
(f) Qualified State-Designated Entity.--For purposes of
this section, to be a qualified State-designated entity, with
respect to a State, an entity shall--
(1) be designated by the State as eligible to
receive awards under this section;
(2) be a not-for-profit entity with broad
stakeholder representation on its governing board;
(3) demonstrate that one of its principal goals is
to use information technology to improve health care
quality and efficiency through the authorized and
secure electronic exchange and use of health
information;
(4) adopt nondiscrimination and conflict of
interest policies that demonstrate a commitment to
open, fair, and nondiscriminatory participation by
stakeholders; and
(5) conform to such other requirements as the
Secretary may establish.
(g) Required Consultation.--In carrying out activities
described in subsections (b) and (c), a State or qualified
State-designated entity shall consult with and consider the
recommendations of--
(1) health care providers (including providers that
provide services to low income and underserved
populations);
(2) health plans;
(3) patient or consumer organizations that
represent the population to be served;
(4) health information technology vendors;
(5) health care purchasers and employers;
(6) public health agencies;
(7) health professions schools, universities and
colleges;
(8) clinical researchers;
(9) other users of health information technology
such as the support and clerical staff of providers and
others involved in the care and care coordination of
patients; and
(10) such other entities, as may be determined
appropriate by the Secretary.
(h) Continuous Improvement.--The Secretary shall annually
evaluate the activities conducted under this section and shall,
in awarding grants under this section, implement the lessons
learned from such evaluation in a manner so that awards made
subsequent to each such evaluation are made in a manner that,
in the determination of the Secretary, will lead towards the
greatest improvement in quality of care, decrease in costs, and
the most effective authorized and secure electronic exchange of
health information.
(i) Required Match.--
(1) In general.--For a fiscal year (beginning with
fiscal year 2011), the Secretary may not make a grant
under this section to a State unless the State agrees
to make available non-Federal contributions (which may
include in-kind contributions) toward the costs of a
grant awarded under subsection (c) in an amount equal
to--
(A) for fiscal year 2011, not less than $1
for each $10 of Federal funds provided under
the grant;
(B) for fiscal year 2012, not less than $1
for each $7 of Federal funds provided under the
grant; and
(C) for fiscal year 2013 and each
subsequent fiscal year, not less than $1 for
each $3 of Federal funds provided under the
grant.
(2) Authority to require state match for fiscal
years before fiscal year 2011.--For any fiscal year
during the grant program under this section before
fiscal year 2011, the Secretary may determine the
extent to which there shall be required a non-Federal
contribution from a State receiving a grant under this
section.
SEC. 3014. [300JJ-34] COMPETITIVE GRANTS TO STATES AND INDIAN TRIBES
FOR THE DEVELOPMENT OF LOAN PROGRAMS TO FACILITATE
THE WIDESPREAD ADOPTION OF CERTIFIED EHR
TECHNOLOGY.
(a) In General.--The National Coordinator may award
competitive grants to eligible entities for the establishment
of programs for loans to health care providers to conduct the
activities described in subsection (e).
(b) Eligible Entity Defined.--For purposes of this
subsection, the term ``eligible entity'' means a State or
Indian tribe (as defined in the Indian Self-Determination and
Education Assistance Act) that--
(1) submits to the National Coordinator an
application at such time, in such manner, and
containing such information as the National Coordinator
may require;
(2) submits to the National Coordinator a strategic
plan in accordance with subsection (d) and provides to
the National Coordinator assurances that the entity
will update such plan annually in accordance with such
subsection;
(3) provides assurances to the National Coordinator
that the entity will establish a Loan Fund in
accordance with subsection (c);
(4) provides assurances to the National Coordinator
that the entity will not provide a loan from the Loan
Fund to a health care provider unless the provider
agrees to--
(A) submit reports on quality measures
adopted by the Federal Government (by not later
than 90 days after the date on which such
measures are adopted), to--
(i) the Administrator of the
Centers for Medicare & Medicaid
Services (or his or her designee), in
the case of an entity participating in
the Medicare program under title XVIII
of the Social Security Act or the
Medicaid program under title XIX of
such Act; or
(ii) the Secretary in the case of
other entities;
(B) demonstrate to the satisfaction of the
Secretary (through criteria established by the
Secretary) that any certified EHR technology
purchased, improved, or otherwise financially
supported under a loan under this section is
used to exchange health information in a manner
that, in accordance with law and standards (as
adopted under section 3004) applicable to the
exchange of information, improves the quality
of health care, such as promoting care
coordination; and
(C) comply with such other requirements as
the entity or the Secretary may require;
(D) include a plan on how health care
providers involved intend to maintain and
support the certified EHR technology over time;
(E) include a plan on how the health care
providers involved intend to maintain and
support the certified EHR technology that would
be purchased with such loan, including the type
of resources expected to be involved and any
such other information as the State or Indian
Tribe, respectively, may require; and
(5) agrees to provide matching funds in accordance
with subsection (h).
(c) Establishment of Fund.--For purposes of subsection
(b)(3), an eligible entity shall establish a certified EHR
technology loan fund (referred to in this subsection as a
``Loan Fund'') and comply with the other requirements contained
in this section. A grant to an eligible entity under this
section shall be deposited in the Loan Fund established by the
eligible entity. No funds authorized by other provisions of
this title to be used for other purposes specified in this
title shall be deposited in any Loan Fund.
(d) Strategic Plan.--
(1) In general.--For purposes of subsection (b)(2),
a strategic plan of an eligible entity under this
subsection shall identify the intended uses of amounts
available to the Loan Fund of such entity.
(2) Contents.--A strategic plan under paragraph
(1), with respect to a Loan Fund of an eligible entity,
shall include for a year the following:
(A) A list of the projects to be assisted
through the Loan Fund during such year.
(B) A description of the criteria and
methods established for the distribution of
funds from the Loan Fund during the year.
(C) A description of the financial status
of the Loan Fund as of the date of submission
of the plan.
(D) The short-term and long-term goals of
the Loan Fund.
(e) Use of Funds.--Amounts deposited in a Loan Fund,
including loan repayments and interest earned on such amounts,
shall be used only for awarding loans or loan guarantees,
making reimbursements described in subsection (g)(4)(A), or as
a source of reserve and security for leveraged loans, the
proceeds of which are deposited in the Loan Fund established
under subsection (c). Loans under this section may be used by a
health care provider to--
(1) facilitate the purchase of certified EHR
technology;
(2) enhance the utilization of certified EHR
technology (which may include costs associated with
upgrading health information technology so that it
meets criteria necessary to be a certified EHR
technology);
(3) train personnel in the use of such technology;
or
(4) improve the secure electronic exchange of
health information.
(f) Types of Assistance.--Except as otherwise limited by
applicable State law, amounts deposited into a Loan Fund under
this section may only be used for the following:
(1) To award loans that comply with the following:
(A) The interest rate for each loan shall
not exceed the market interest rate.
(B) The principal and interest payments on
each loan shall commence not later than 1 year
after the date the loan was awarded, and each
loan shall be fully amortized not later than 10
years after the date of the loan.
(C) The Loan Fund shall be credited with
all payments of principal and interest on each
loan awarded from the Loan Fund.
(2) To guarantee, or purchase insurance for, a
local obligation (all of the proceeds of which finance
a project eligible for assistance under this
subsection) if the guarantee or purchase would improve
credit market access or reduce the interest rate
applicable to the obligation involved.
(3) As a source of revenue or security for the
payment of principal and interest on revenue or general
obligation bonds issued by the eligible entity if the
proceeds of the sale of the bonds will be deposited
into the Loan Fund.
(4) To earn interest on the amounts deposited into
the Loan Fund.
(5) To make reimbursements described in subsection
(g)(4)(A).
(g) Administration of Loan Funds.--
(1) Combined financial administration.--An eligible
entity may (as a convenience and to avoid unnecessary
administrative costs) combine, in accordance with
applicable State law, the financial administration of a
Loan Fund established under this subsection with the
financial administration of any other revolving fund
established by the entity if otherwise not prohibited
by the law under which the Loan Fund was established.
(2) Cost of administering fund.--Each eligible
entity may annually use not to exceed 4 percent of the
funds provided to the entity under a grant under this
section to pay the reasonable costs of the
administration of the programs under this section,
including the recovery of reasonable costs expended to
establish a Loan Fund which are incurred after the date
of the enactment of this title.
(3) Guidance and regulations.--The National
Coordinator shall publish guidance and promulgate
regulations as may be necessary to carry out the
provisions of this section, including--
(A) provisions to ensure that each eligible
entity commits and expends funds allotted to
the entity under this section as efficiently as
possible in accordance with this title and
applicable State laws; and
(B) guidance to prevent waste, fraud, and
abuse.
(4) Private sector contributions.--
(A) In general.--A Loan Fund established
under this section may accept contributions
from private sector entities, except that such
entities may not specify the recipient or
recipients of any loan issued under this
subsection. An eligible entity may agree to
reimburse a private sector entity for any
contribution made under this subparagraph,
except that the amount of such reimbursement
may not be greater than the principal amount of
the contribution made.
(B) Availability of information.--An
eligible entity shall make publicly available
the identity of, and amount contributed by, any
private sector entity under subparagraph (A)
and may issue letters of commendation or make
other awards (that have no financial value) to
any such entity.
(h) Matching Requirements.--
(1) In general.--The National Coordinator may not
make a grant under subsection (a) to an eligible entity
unless the entity agrees to make available (directly or
through donations from public or private entities) non-
Federal contributions in cash to the costs of carrying
out the activities for which the grant is awarded in an
amount equal to not less than $1 for each $5 of Federal
funds provided under the grant.
(2) Determination of amount of non-federal
contribution.--In determining the amount of non-Federal
contributions that an eligible entity has provided
pursuant to subparagraph (A), the National Coordinator
may not include any amounts provided to the entity by
the Federal Government.
(i) Effective Date.--The Secretary may not make an award
under this section prior to January 1, 2010.
SEC. 3015. [300JJ-35] DEMONSTRATION PROGRAM TO INTEGRATE INFORMATION
TECHNOLOGY INTO CLINICAL EDUCATION.
(a) In General.--The Secretary may award grants under this
section to carry out demonstration projects to develop academic
curricula integrating certified EHR technology in the clinical
education of health professionals. Such awards shall be made on
a competitive basis and pursuant to peer review.
(b) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity shall--
(1) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require;
(2) submit to the Secretary a strategic plan for
integrating certified EHR technology in the clinical
education of health professionals to reduce medical
errors, increase access to prevention, reduce chronic
diseases, and enhance health care quality;
(3) be--
(A) a school of medicine, osteopathic
medicine, dentistry, or pharmacy, a graduate
program in behavioral or mental health, or any
other graduate health professions school;
(B) a graduate school of nursing or
physician assistant studies;
(C) a consortium of two or more schools
described in subparagraph (A) or (B); or
(D) an institution with a graduate medical
education program in medicine, osteopathic
medicine, dentistry, pharmacy, nursing, or
physician assistance studies;
(4) provide for the collection of data regarding
the effectiveness of the demonstration project to be
funded under the grant in improving the safety of
patients, the efficiency of health care delivery, and
in increasing the likelihood that graduates of the
grantee will adopt and incorporate certified EHR
technology, in the delivery of health care services;
and
(5) provide matching funds in accordance with
subsection (d).
(c) Use of Funds.--
(1) In general.--With respect to a grant under
subsection (a), an eligible entity shall--
(A) use grant funds in collaboration with 2
or more disciplines; and
(B) use grant funds to integrate certified
EHR technology into community-based clinical
education.
(2) Limitation.--An eligible entity shall not use
amounts received under a grant under subsection (a) to
purchase hardware, software, or services.
(d) Financial Support.--The Secretary may not provide more
than 50 percent of the costs of any activity for which
assistance is provided under subsection (a), except in an
instance of national economic conditions which would render the
cost-share requirement under this subsection detrimental to the
program and upon notification to Congress as to the
justification to waive the cost-share requirement.
(e) Evaluation.--The Secretary shall take such action as
may be necessary to evaluate the projects funded under this
section and publish, make available, and disseminate the
results of such evaluations on as wide a basis as is
practicable.
(f) Reports.--Not later than 1 year after the date of
enactment of this title, and annually thereafter, the Secretary
shall submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Finance of the Senate, and the
Committee on Energy and Commerce of the House of
Representatives a report that--
(1) describes the specific projects established
under this section; and
(2) contains recommendations for Congress based on
the evaluation conducted under subsection (e).
SEC. 3016. [300JJ-36] INFORMATION TECHNOLOGY PROFESSIONALS IN HEALTH
CARE.
(a) In General.--The Secretary, in consultation with the
Director of the National Science Foundation, shall provide
assistance to institutions of higher education (or consortia
thereof) to establish or expand medical health informatics
education programs, including certification, undergraduate, and
masters degree programs, for both health care and information
technology students to ensure the rapid and effective
utilization and development of health information technologies
(in the United States health care infrastructure).
(b) Activities.--Activities for which assistance may be
provided under subsection (a) may include the following:
(1) Developing and revising curricula in medical
health informatics and related disciplines.
(2) Recruiting and retaining students to the
program involved.
(3) Acquiring equipment necessary for student
instruction in these programs, including the
installation of testbed networks for student use.
(4) Establishing or enhancing bridge programs in
the health informatics fields between community
colleges and universities.
(c) Priority.--In providing assistance under subsection
(a), the Secretary shall give preference to the following:
(1) Existing education and training programs.
(2) Programs designed to be completed in less than
six months.
SEC. 3017. [300JJ-37] GENERAL GRANT AND LOAN PROVISIONS.
(a) Reports.--The Secretary may require that an entity
receiving assistance under this subtitle shall submit to the
Secretary, not later than the date that is 1 year after the
date of receipt of such assistance, a report that includes--
(1) an analysis of the effectiveness of the
activities for which the entity receives such
assistance, as compared to the goals for such
activities; and
(2) an analysis of the impact of the project on
health care quality and safety.
(b) Requirement to Improve Quality of Care and Decrease in
Costs.--The National Coordinator shall annually evaluate the
activities conducted under this subtitle and shall, in awarding
grants, implement the lessons learned from such evaluation in a
manner so that awards made subsequent to each such evaluation
are made in a manner that, in the determination of the National
Coordinator, will result in the greatest improvement in the
quality and efficiency of health care.
SEC. 3018. [300JJ-38] AUTHORIZATION FOR APPROPRIATIONS.
For the purposes of carrying out this subtitle, there is
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2009 through 2013.
Subtitle C--Other Provisions
SEC. 3021. [300JJ-51] HEALTH INFORMATION TECHNOLOGY ENROLLMENT
STANDARDS AND PROTOCOLS.
(a) In General.--
(1) Standards and protocols.--Not later than 180
days after the date of enactment of this title, the
Secretary, in consultation with the HIT Policy
Committee and the HIT Standards Committee, shall
develop interoperable and secure standards and
protocols that facilitate enrollment of individuals in
Federal and State health and human services programs,
as determined by the Secretary.
(2) Methods.--The Secretary shall facilitate
enrollment in such programs through methods determined
appropriate by the Secretary, which shall include
providing individuals and third parties authorized by
such individuals and their designees notification of
eligibility and verification of eligibility required
under such programs.
(b) Content.--The standards and protocols for electronic
enrollment in the Federal and State programs described in
subsection (a) shall allow for the following:
(1) Electronic matching against existing Federal
and State data, including vital records, employment
history, enrollment systems, tax records, and other
data determined appropriate by the Secretary to serve
as evidence of eligibility and in lieu of paper-based
documentation.
(2) Simplification and submission of electronic
documentation, digitization of documents, and systems
verification of eligibility.
(3) Reuse of stored eligibility information
(including documentation) to assist with retention of
eligible individuals.
(4) Capability for individuals to apply, recertify
and manage their eligibility information online,
including at home, at points of service, and other
community-based locations.
(5) Ability to expand the enrollment system to
integrate new programs, rules, and functionalities, to
operate at increased volume, and to apply streamlined
verification and eligibility processes to other Federal
and State programs, as appropriate.
(6) Notification of eligibility, recertification,
and other needed communication regarding eligibility,
which may include communication via email and cellular
phones.
(7) Other functionalities necessary to provide
eligibles with streamlined enrollment process.
(c) Approval and Notification.--With respect to any
standard or protocol developed under subsection (a) that has
been approved by the HIT Policy Committee and the HIT Standards
Committee, the Secretary--
(1) shall notify States of such standards or
protocols; and
(2) may require, as a condition of receiving
Federal funds for the health information technology
investments, that States or other entities incorporate
such standards and protocols into such investments.
(d) Grants for Implementation of Appropriate Enrollment
HIT.--
(1) In general.--The Secretary shall award grant to
eligible entities to develop new, and adapt existing,
technology systems to implement the HIT enrollment
standards and protocols developed under subsection (a)
(referred to in this subsection as ``appropriate HIT
technology'').
(2) Eligible entities.--To be eligible for a grant
under this subsection, an entity shall--
(A) be a State, political subdivision of a
State, or a local governmental entity; and
(B) submit to the Secretary an application
at such time, in such manner, and containing--
(i) a plan to adopt and implement
appropriate enrollment technology that
includes--
(I) proposed reduction in
maintenance costs of technology
systems;
(II) elimination or
updating of legacy systems; and
(III) demonstrated
collaboration with other
entities that may receive a
grant under this section that
are located in the same State,
political subdivision, or
locality;
(ii) an assurance that the entity
will share such appropriate enrollment
technology in accordance with paragraph
(4); and
(iii) such other information as the
Secretary may require.
(3) Sharing.--
(A) In general.--The Secretary shall ensure
that appropriate enrollment HIT adopted under
grants under this subsection is made available
to other qualified State, qualified political
subdivisions of a State, or other appropriate
qualified entities (as described in
subparagraph (B)) at no cost.
(B) Qualified entities.--The Secretary
shall determine what entities are qualified to
receive enrollment HIT under subparagraph (A),
taking into consideration the recommendations
of the HIT Policy Committee and the HIT
Standards Committee.
TITLE XXXI--DATA COLLECTION, ANALYSIS, AND QUALITY
SEC. 3101. [300KK] DATA COLLECTION, ANALYSIS, AND QUALITY.
(a) Data Collection.--
(1) In general.--The Secretary shall ensure that,
by not later than 2 years after the date of enactment
of this title, any federally conducted or supported
health care or public health program, activity or
survey (including Current Population Surveys and
American Community Surveys conducted by the Bureau of
Labor Statistics and the Bureau of the Census) collects
and reports, to the extent practicable--
(A) data on race, ethnicity, sex, primary
language, and disability status for applicants,
recipients, or participants;
(B) data at the smallest geographic level
such as State, local, or institutional levels
if such data can be aggregated;
(C) sufficient data to generate
statistically reliable estimates by racial,
ethnic, sex, primary language, and disability
status subgroups for applicants, recipients or
participants using, if needed, statistical
oversamples of these subpopulations; and
(D) any other demographic data as deemed
appropriate by the Secretary regarding health
disparities.
(2) Collection standards.--In collecting data
described in paragraph (1), the Secretary or designee
shall--
(A) use Office of Management and Budget
standards, at a minimum, for race and ethnicity
measures;
(B) develop standards for the measurement
of sex, primary language, and disability
status;
(C) develop standards for the collection of
data described in paragraph (1) that, at a
minimum--
(i) collects self-reported data by
the applicant, recipient, or
participant; and
(ii) collects data from a parent or
legal guardian if the applicant,
recipient, or participant is a minor or
legally incapacitated;
(D) survey health care providers and
establish other procedures in order to assess
access to care and treatment for individuals
with disabilities and to identify--
(i) locations where individuals
with disabilities access primary, acute
(including intensive), and long-term
care;
(ii) the number of providers with
accessible facilities and equipment to
meet the needs of the individuals with
disabilities, including medical
diagnostic equipment that meets the
minimum technical criteria set forth in
section 510 of the Rehabilitation Act
of 1973; and
(iii) the number of employees of
health care providers trained in
disability awareness and patient care
of individuals with disabilities; and
(E) require that any reporting requirement
imposed for purposes of measuring quality under
any ongoing or federally conducted or supported
health care or public health program, activity,
or survey includes requirements for the
collection of data on individuals receiving
health care items or services under such
programs activities by race, ethnicity, sex,
primary language, and disability status.
(3) Data management.--In collecting data described
in paragraph (1), the Secretary, acting through the
National Coordinator for Health Information Technology
shall--
(A) develop national standards for the
management of data collected; and
(B) develop interoperability and security
systems for data management.
(b) \1\ Data Analysis.--
---------------------------------------------------------------------------
\1\ So in law. Subsection (b) includes a paragraph (1) but there
are no subsequent paragraphs.
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(1) In general.--For each federally conducted or
supported health care or public health program or
activity, the Secretary shall analyze data collected
under paragraph (a) to detect and monitor trends in
health disparities (as defined for purposes of section
485E) at the Federal and State levels.
(c) Data Reporting and Dissemination.--
(1) In general.--The Secretary shall make the
analyses described in (b) available to--
(A) the Office of Minority Health;
(B) the National Center on Minority Health
and Health Disparities;
(C) the Agency for Healthcare Research and
Quality;
(D) the Centers for Disease Control and
Prevention;
(E) the Centers for Medicare & Medicaid
Services;
(F) the Indian Health Service and
epidemiology centers funded under the Indian
Health Care Improvement Act;
(G) the Office of Rural health;
(H) other agencies within the Department of
Health and Human Services; and
(I) other entities as determined
appropriate by the Secretary.
(2) Reporting of data.--The Secretary shall report
data and analyses described in (a) and (b) through--
(A) public postings on the Internet
websites of the Department of Health and Human
Services; and
(B) any other reporting or dissemination
mechanisms determined appropriate by the
Secretary.
(3) Availability of data.--The Secretary may make
data described in (a) and (b) available for additional
research, analyses, and dissemination to other Federal
agencies, non-governmental entities, and the public, in
accordance with any Federal agency's data user
agreements.
(d) Limitations on Use of Data.--Nothing in this section
shall be construed to permit the use of information collected
under this section in a manner that would adversely affect any
individual.
(e) Protection and Sharing of Data.--
(1) Privacy and other safeguards.--The Secretary
shall ensure (through the promulgation of regulations
or otherwise) that--
(A) all data collected pursuant to
subsection (a) is protected--
(i) under privacy protections that
are at least as broad as those that the
Secretary applies to other health data
under the regulations promulgated under
section 264(c) of the Health Insurance
Portability and Accountability Act of
1996 (Public Law 104-191; 110 Stat.
2033); and
(ii) from all inappropriate
internal use by any entity that
collects, stores, or receives the data,
including use of such data in
determinations of eligibility (or
continued eligibility) in health plans,
and from other inappropriate uses, as
defined by the Secretary; and
(B) all appropriate information security
safeguards are used in the collection,
analysis, and sharing of data collected
pursuant to subsection (a).
(2) Data sharing.--The Secretary shall establish
procedures for sharing data collected pursuant to
subsection (a), measures relating to such data, and
analyses of such data, with other relevant Federal and
State agencies including the agencies, centers, and
entities within the Department of Health and Human
Services specified in subsection (c)(1)..
(f) Data on Rural Underserved Populations.--The Secretary
shall ensure that any data collected in accordance with this
section regarding racial and ethnic minority groups are also
collected regarding underserved rural and frontier populations.
(g) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2010 through 2014.
(h) Requirement for Implementation.--Notwithstanding any
other provision of this section, data may not be collected
under this section unless funds are directly appropriated for
such purpose in an appropriations Act.
(i) Consultation.--The Secretary shall consult with the
Director of the Office of Personnel Management, the Secretary
of Defense, the Secretary of Veterans Affairs, the Director of
the Bureau of the Census, the Commissioner of Social Security,
and the head of other appropriate Federal agencies in carrying
out this section.
======================================================================
TITLE XXXII--COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS
[Note: Effective January 1, 2011, section 8002(a)(1) of
Public Law 111-148 provides for an amendment to add at the end
of the Public Health Service Act a new title XXXII as follows:]
SEC. 3201. [300LL] PURPOSE.
The purpose of this title is to establish a national
voluntary insurance program for purchasing community living
assistance services and supports in order to--
(1) provide individuals with functional limitations
with tools that will allow them to maintain their
personal and financial independence and live in the
community through a new financing strategy for
community living assistance services and supports;
(2) establish an infrastructure that will help
address the Nation's community living assistance
services and supports needs;
(3) alleviate burdens on family caregivers; and
(4) address institutional bias by providing a
financing mechanism that supports personal choice and
independence to live in the community.
SEC. 3202. [300LL-1] DEFINITIONS.
In this title:
(1) Active enrollee.--The term ``active enrollee''
means an individual who is enrolled in the CLASS
program in accordance with section 3204 and who has
paid any premiums due to maintain such enrollment.
(2) Actively employed.--The term ``actively
employed'' means an individual who--
(A) is reporting for work at the
individual's usual place of employment or at
another location to which the individual is
required to travel because of the individual's
employment (or in the case of an individual who
is a member of the uniformed services, is on
active duty and is physically able to perform
the duties of the individual's position); and
(B) is able to perform all the usual and
customary duties of the individual's employment
on the individual's regular work schedule.
(3) Activities of daily living.--The term
``activities of daily living'' means each of the
following activities specified in section
7702B(c)(2)(B) of the Internal Revenue Code of 1986:
(A) Eating.
(B) Toileting.
(C) Transferring.
(D) Bathing.
(E) Dressing.
(F) Continence.
(4) CLASS program.--The term ``CLASS program''
means the program established under this title.
(5) Eligibility assessment system.--The term
``Eligibility Assessment System'' means the entity
established by the Secretary under section 3205(a)(2)
to make functional eligibility determinations for the
CLASS program.
(6) Eligible beneficiary.--
(A) In general.--The term ``eligible
beneficiary'' means any individual who is an
active enrollee in the CLASS program and, as of
the date described in subparagraph (B)--
(i) has paid premiums for
enrollment in such program for at least
60 months;
(ii) has earned, with respect to at
least 3 calendar years that occur
during the first 60 months for which
the individual has paid premiums for
enrollment in the program, at least an
amount equal to the amount of wages and
self-employment income which an
individual must have in order to be
credited with a quarter of coverage
under section 213(d) of the Social
Security Act for the year; and
(iii) has paid premiums for
enrollment in such program for at least
24 consecutive months, if a lapse in
premium payments of more than 3 months
has occurred during the period that
begins on the date of the individual's
enrollment and ends on the date of such
determination.
(B) Date described.--For purposes of
subparagraph (A), the date described in this
subparagraph is the date on which the
individual is determined to have a functional
limitation described in section 3203(a)(1)(C)
that is expected to last for a continuous
period of more than 90 days.
(C) Regulations.--The Secretary shall
promulgate regulations specifying exceptions to
the minimum earnings requirements under
subparagraph (A)(ii) for purposes of being
considered an eligible beneficiary for certain
populations.
(7) Hospital; nursing facility; intermediate care
facility for the mentally retarded; institution for
mental diseases.--The terms ``hospital'', ``nursing
facility'', ``intermediate care facility for the
mentally retarded'', and ``institution for mental
diseases'' have the meanings given such terms for
purposes of Medicaid.
(8) CLASS independence advisory council.--The term
``CLASS Independence Advisory Council'' or ``Council''
means the Advisory Council established under section
3207 to advise the Secretary.
(9) CLASS independence benefit plan.--The term
``CLASS Independence Benefit Plan'' means the benefit
plan developed and designated by the Secretary in
accordance with section 3203.
(10) CLASS independence fund.--The term ``CLASS
Independence Fund'' or ``Fund'' means the fund
established under section 3206.
(11) Medicaid.--The term ``Medicaid'' means the
program established under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.).
(12) Poverty line.--The term ``poverty line'' has
the meaning given that term in section 2110(c)(5) of
the Social Security Act (42 U.S.C. 1397jj(c)(5)).
(13) Protection and advocacy system.--The term
``Protection and Advocacy System'' means the system for
each State established under section 143 of the
Developmental Disabilities Assistance and Bill of
Rights Act of 2000 (42 U.S.C. 15043).
SEC. 3203. [300LL-2] CLASS INDEPENDENCE BENEFIT PLAN.
(a) Process for Development.--
(1) In general.--The Secretary, in consultation
with appropriate actuaries and other experts, shall
develop at least 3 actuarially sound benefit plans as
alternatives for consideration for designation by the
Secretary as the CLASS Independence Benefit Plan under
which eligible beneficiaries shall receive benefits
under this title. Each of the plan alternatives
developed shall be designed to provide eligible
beneficiaries with the benefits described in section
3205 consistent with the following requirements:
(A) Premiums.--
(i) In general.--Beginning with the
first year of the CLASS program, and
for each year thereafter, subject to
clauses (ii) and (iii), the Secretary
shall establish all premiums to be paid
by enrollees for the year based on an
actuarial analysis of the 75-year costs
of the program that ensures solvency
throughout such 75-year period.
(ii) Nominal premium for poorest
individuals and full-time students.--
(I) In general.--The
monthly premium for enrollment
in the CLASS program shall not
exceed the applicable dollar
amount per month determined
under subclause (II) for--
(aa) any individual
whose income does not
exceed the poverty
line; and
(bb) any individual
who has not attained
age 22, and is actively
employed during any
period in which the
individual is a full-
time student (as
determined by the
Secretary).
(II) Applicable dollar
amount.--The applicable dollar
amount described in this
subclause is the amount equal
to $5, increased by the
percentage increase in the
consumer price index for all
urban consumers (U.S. city
average) for each year
occurring after 2009 and before
such year.
(iii) Class independence fund
reserves.--At such time as the CLASS
program has been in operation for 10
years, the Secretary shall establish
all premiums to be paid by enrollees
for the year based on an actuarial
analysis that accumulated reserves in
the CLASS Independence Fund would not
decrease in that year. At such time as
the Secretary determines the CLASS
program demonstrates a sustained
ability to finance expected yearly
expenses with expected yearly premiums
and interest credited to the CLASS
Independence Fund, the Secretary may
decrease the required amount of CLASS
Independence Fund reserves.
(B) Vesting period.--A 5-year vesting
period for eligibility for benefits.
(C) Benefit triggers.--A benefit trigger
for provision of benefits that requires a
determination that an individual has a
functional limitation, as certified by a
licensed health care practitioner, described in
any of the following clauses that is expected
to last for a continuous period of more than 90
days:
(i) The individual is determined to
be unable to perform at least the
minimum number (which may be 2 or 3) of
activities of daily living as are
required under the plan for the
provision of benefits without
substantial assistance (as defined by
the Secretary) from another individual.
(ii) The individual requires
substantial supervision to protect the
individual from threats to health and
safety due to substantial cognitive
impairment.
(iii) The individual has a level of
functional limitation similar (as
determined under regulations prescribed
by the Secretary) to the level of
functional limitation described in
clause (i) or (ii).
(D) Cash benefit.--Payment of a cash
benefit that satisfies the following
requirements:
(i) Minimum required amount.--The
benefit amount provides an eligible
beneficiary with not less than an
average of $50 per day (as determined
based on the reasonably expected
distribution of beneficiaries receiving
benefits at various benefit levels).
(ii) Amount scaled to functional
ability.--The benefit amount is varied
based on a scale of functional ability,
with not less than 2, and not more than
6, benefit level amounts.
(iii) Daily or weekly.--The benefit
is paid on a daily or weekly basis.
(iv) No lifetime or aggregate
limit.--The benefit is not subject to
any lifetime or aggregate limit.
(2) Review and recommendation by the class
independence advisory council.--The CLASS Independence
Advisory Council shall--
(A) evaluate the alternative benefit plans
developed under paragraph (1); and
(B) recommend for designation as the CLASS
Independence Benefit Plan for offering to the
public the plan that the Council determines
best balances price and benefits to meet
enrollees' needs in an actuarially sound
manner, while optimizing the probability of the
long-term sustainability of the CLASS program.
(3) Designation by the secretary.--Not later than
October 1, 2012, the Secretary, taking into
consideration the recommendation of the CLASS
Independence Advisory Council under paragraph (2)(B),
shall designate a benefit plan as the CLASS
Independence Benefit Plan. The Secretary shall publish
such designation, along with details of the plan and
the reasons for the selection by the Secretary, in a
final rule that allows for a period of public comment.
(b) Additional Premium Requirements.--
(1) Adjustment of premiums.--
(A) In general.--Except as provided in
subparagraphs (B), (C), (D), and (E), the
amount of the monthly premium determined for an
individual upon such individual's enrollment in
the CLASS program shall remain the same for as
long as the individual is an active enrollee in
the program.
(B) Recalculated premium if required for
program solvency.--
(i) In general.--Subject to clause
(ii), if the Secretary determines,
based on the most recent report of the
Board of Trustees of the CLASS
Independence Fund, the advice of the
CLASS Independence Advisory Council,
and the annual report of the Inspector
General of the Department of Health and
Human Services, and waste, fraud, and
abuse, or such other information as the
Secretary determines appropriate, that
the monthly premiums and income to the
CLASS Independence Fund for a year are
projected to be insufficient with
respect to the 20-year period that
begins with that year, the Secretary
shall adjust the monthly premiums for
individuals enrolled in the CLASS
program as necessary (but maintaining a
nominal premium for enrollees whose
income is below the poverty line or who
are full-time students actively
employed).
(ii) Exemption from increase.--Any
increase in a monthly premium imposed
as result of a determination described
in clause (i) shall not apply with
respect to the monthly premium of any
active enrollee who--
(I) has attained age 65;
(II) has paid premiums for
enrollment in the program for
at least 20 years; and
(III) is not actively
employed.
(C) Recalculated premium if reenrollment
after more than a 3-month lapse.--
(i) In general.--The reenrollment
of an individual after a 90-day period
during which the individual failed to
pay the monthly premium required to
maintain the individual's enrollment in
the CLASS program shall be treated as
an initial enrollment for purposes of
age-adjusting the premium for
reenrollment in the program.
(ii) Credit for prior months if
reenrolled within 5 years.--An
individual who reenrolls in the CLASS
program after such a 90-day period and
before the end of the 5-year period
that begins with the first month for
which the individual failed to pay the
monthly premium required to maintain
the individual's enrollment in the
program shall be--
(I) credited with any
months of paid premiums that
accrued prior to the
individual's lapse in
enrollment; and
(II) notwithstanding the
total amount of any such
credited months, required to
satisfy section 3202(6)(A)(ii)
before being eligible to
receive benefits.
(D) No longer status as a full-time
student.--An individual subject to a nominal
premium on the basis of being described in
subsection (a)(1)(A)(ii)(I)(bb) who ceases to
be described in that subsection, beginning with
the first month following the month in which
the individual ceases to be so described, shall
be subject to the same monthly premium as the
monthly premium that applies to an individual
of the same age who first enrolls in the
program under the most similar circumstances as
the individual (such as the first year of
eligibility for enrollment in the program or in
a subsequent year).
(E) Penalty for reenollment after 5-year
lapse.--In the case of an individual who
reenrolls in the CLASS program after the end of
the 5-year period described in subparagraph
(C)(ii), the monthly premium required for the
individual shall be the age-adjusted premium
that would be applicable to an initially
enrolling individual who is the same age as the
reenrolling individual, increased by the
greater of--
(i) an amount that the Secretary
determines is actuarially sound for
each month that occurs during the
period that begins with the first month
for which the individual failed to pay
the monthly premium required to
maintain the individual's enrollment in
the CLASS program and ends with the
month preceding the month in which the
reenollment is effective; or
(ii) 1 percent of the applicable
age-adjusted premium for each such
month occurring in such period.
(2) Administrative expenses.--In determining the
monthly premiums for the CLASS program the Secretary
may factor in costs for administering the program, not
to exceed for any year in which the program is in
effect under this title, an amount equal to 3 percent
of all premiums paid during the year.
(3) No underwriting requirements.--No underwriting
(other than on the basis of age in accordance with
subparagraphs (D) and (E) of paragraph (1)) shall be
used to--
(A) determine the monthly premium for
enrollment in the CLASS program; or
(B) prevent an individual from enrolling in
the program.
(c) Self-attestation and Verification of Income.--The
Secretary shall establish procedures to--
(1) permit an individual who is eligible for the
nominal premium required under subsection (a)(1)(A)(ii)
to self-attest that their income does not exceed the
poverty line or that their status as a full-time
student who is actively employed;
(2) verify, using procedures similar to the
procedures used by the Commissioner of Social Security
under section 1631(e)(1)(B)(ii) of the Social Security
Act and consistent with the requirements applicable to
the conveyance of data and information under section
1942 of such Act, the validity of such self-
attestation; and
(3) require an individual to confirm, on at least
an annual basis, that their income does not exceed the
poverty line or that they continue to maintain such
status.
SEC. 3204. [300LL-3] ENROLLMENT AND DISENROLLMENT REQUIREMENTS.
(a) Automatic Enrollment.--
(1) In general.--Subject to paragraph (2), the
Secretary, in coordination with the Secretary of the
Treasury, shall establish procedures under which each
individual described in subsection (c) may be
automatically enrolled in the CLASS program by an
employer of such individual in the same manner as an
employer may elect to automatically enroll employees in
a plan under section 401(k), 403(b), or 457 of the
Internal Revenue Code of 1986.
(2) Alternative enrollment procedures.--The
procedures established under paragraph (1) shall
provide for an alternative enrollment process for an
individual described in subsection (c) in the case of
such an individual--
(A) who is self-employed;
(B) who has more than 1 employer; or
(C) whose employer does not elect to
participate in the automatic enrollment process
established by the Secretary.
(3) Administration.--
(A) In general.--The Secretary and the
Secretary of the Treasury shall, by regulation,
establish procedures to ensure that an
individual is not automatically enrolled in the
CLASS program by more than 1 employer.
(B) Form.--Enrollment in the CLASS program
shall be made in such manner as the Secretary
may prescribe in order to ensure ease of
administration.
(b) Election to Opt-Out.--An individual described in
subsection (c) may elect to waive enrollment in the CLASS
program at any time in such form and manner as the Secretary
and the Secretary of the Treasury shall prescribe.
(c) Individual Described.--For purposes of enrolling in the
CLASS program, an individual described in this paragraph is an
individual--
(1) who has attained age 18;
(2) who--
(A) receives wages or income on which there
is imposed a tax under section 3101(a) or
3201(a) of the Internal Revenue Code of 1986;
or
(B) derives self-employment income on which
there is imposed a tax under section 1401(a) of
the Internal Revenue Code of 1986;
(3) who is actively employed; and
(4) who is not--
(A) a patient in a hospital or nursing
facility, an intermediate care facility for the
mentally retarded, or an institution for mental
diseases and receiving medical assistance under
Medicaid; or
(B) confined in a jail, prison, other penal
institution or correctional facility, or by
court order pursuant to conviction of a
criminal offense or in connection with a
verdict or finding described in section
202(x)(1)(A)(ii) of the Social Security Act (42
U.S.C. 402(x)(1)(A)(ii)).
(d) Rule of Construction.--Nothing in this title shall be
construed as requiring an active enrollee to continue to
satisfy subparagraph (A) or (B) of subsection (c)(2) in order
to maintain enrollment in the CLASS program.
(e) Payment.--
(1) Payroll deduction.--An amount equal to the
monthly premium for the enrollment in the CLASS program
of an individual shall be deducted from the wages or
self-employment income of such individual in accordance
with such procedures as the Secretary, in coordination
with the Secretary of the Treasury, shall establish for
employers who elect to deduct and withhold such
premiums on behalf of enrolled employees.
(2) Alternative payment mechanism.--The Secretary,
in coordination with the Secretary of the Treasury,
shall establish alternative procedures for the payment
of monthly premiums by an individual enrolled in the
CLASS program--
(A) who does not have an employer who
elects to deduct and withhold premiums in
accordance with paragraph (1); or
(B) who does not earn wages or derive self-
employment income.
(f) Transfer of Premiums Collected.--
(1) In general.--During each calendar year the
Secretary of the Treasury shall deposit into the CLASS
Independence Fund a total amount equal, in the
aggregate, to 100 percent of the premiums collected
during that year.
(2) Transfers based on estimates.--The amount
deposited pursuant to paragraph (1) shall be
transferred in at least monthly payments to the CLASS
Independence Fund on the basis of estimates by the
Secretary and certified to the Secretary of the
Treasury of the amounts collected in accordance with
subparagraphs (A) and (B) of paragraph (5). Proper
adjustments shall be made in amounts subsequently
transferred to the Fund to the extent prior estimates
were in excess of, or were less than, actual amounts
collected.
(g) Other Enrollment and Disenrollment Opportunities.--The
Secretary, in coordination with the Secretary of the Treasury,
shall establish procedures under which--
(1) an individual who, in the year of the
individual's initial eligibility to enroll in the CLASS
program, has not enrolled in the program, is eligible
to elect to enroll in the program, in such form and
manner as the Secretaries shall establish, only during
an open enrollment period established by the
Secretaries that is specific to the individual and that
may not occur more frequently than biennially after the
date on which the individual first elected to waive
enrollment in the program; and
(2) an individual shall only be permitted to
disenroll from the program (other than for nonpayment
of premiums) during an annual disenrollment period
established by the Secretaries and in such form and
manner as the Secretaries shall establish.
SEC. 3205. [300LL-4] BENEFITS.
(a) Determination of Eligibility.--
(1) Application for receipt of benefits.--The
Secretary shall establish procedures under which an
active enrollee shall apply for receipt of benefits
under the CLASS Independence Benefit Plan.
(2) Eligibility assessments.--
(A) In general.--Not later than January 1,
2012, the Secretary shall--
(i) establish an Eligibility
Assessment System (other than a service
with which the Commissioner of Social
Security has entered into an agreement,
with respect to any State, to make
disability determinations for purposes
of title II or XVI of the Social
Security Act) to provide for
eligibility assessments of active
enrollees who apply for receipt of
benefits;
(ii) enter into an agreement with
the Protection and Advocacy System for
each State to provide advocacy services
in accordance with subsection (d); and
(iii) enter into an agreement with
public and private entities to provide
advice and assistance counseling in
accordance with subsection (e).
(B) Regulations.--The Secretary shall
promulgate regulations to develop an expedited
nationally equitable eligibility determination
process, as certified by a licensed health care
practitioner, an appeals process, and a
redetermination process, as certified by a
licensed health care practitioner, including
whether an active enrollee is eligible for a
cash benefit under the program and if so, the
amount of the cash benefit (in accordance the
sliding scale established under the plan).
(C) Presumptive eligibility for certain
institutionalized enrollees planning to
discharge.--An active enrollee shall be deemed
presumptively eligible if the enrollee--
(i) has applied for, and attests is
eligible for, the maximum cash benefit
available under the sliding scale
established under the CLASS
Independence Benefit Plan;
(ii) is a patient in a hospital
(but only if the hospitalization is for
long-term care), nursing facility,
intermediate care facility for the
mentally retarded, or an institution
for mental diseases; and
(iii) is in the process of, or
about to begin the process of, planning
to discharge from the hospital,
facility, or institution, or within 60
days from the date of discharge from
the hospital, facility, or institution.
(D) Appeals.--The Secretary shall establish
procedures under which an applicant for
benefits under the CLASS Independence Benefit
Plan shall be guaranteed the right to appeal an
adverse determination.
(b) Benefits.--An eligible beneficiary shall receive the
following benefits under the CLASS Independence Benefit Plan:
(1) Cash benefit.--A cash benefit established by
the Secretary in accordance with the requirements of
section 3203(a)(1)(D) that--
(A) the first year in which beneficiaries
receive the benefits under the plan, is not
less than the average dollar amount specified
in clause (i) of such section; and
(B) for any subsequent year, is not less
than the average per day dollar limit
applicable under this subparagraph for the
preceding year, increased by the percentage
increase in the consumer price index for all
urban consumers (U.S. city average) over the
previous year.
(2) Advocacy services.--Advocacy services in
accordance with subsection (d).
(3) Advice and assistance counseling.--Advice and
assistance counseling in accordance with subsection
(e).
(4) Administrative expenses.--Advocacy services and
advise and assistance counseling services under
paragraphs (2) and (3) of this subsection shall be
included as administrative expenses under section
3203(b)(3).
(c) Payment of Benefits.--
(1) Life independence account.--
(A) In general.--The Secretary shall
establish procedures for administering the
provision of benefits to eligible beneficiaries
under the CLASS Independence Benefit Plan,
including the payment of the cash benefit for
the beneficiary into a Life Independence
Account established by the Secretary on behalf
of each eligible beneficiary.
(B) Use of cash benefits.--Cash benefits
paid into a Life Independence Account of an
eligible beneficiary shall be used to purchase
nonmedical services and supports that the
beneficiary needs to maintain his or her
independence at home or in another residential
setting of their choice in the community,
including (but not limited to) home
modifications, assistive technology, accessible
transportation, homemaker services, respite
care, personal assistance services, home care
aides, and nursing support. Nothing in the
preceding sentence shall prevent an eligible
beneficiary from using cash benefits paid into
a Life Independence Account for obtaining
assistance with decision making concerning
medical care, including the right to accept or
refuse medical or surgical treatment and the
right to formulate advance directives or other
written instructions recognized under State
law, such as a living will or durable power of
attorney for health care, in the case that an
injury or illness causes the individual to be
unable to make health care decisions.
(C) Electronic management of funds.--The
Secretary shall establish procedures for--
(i) crediting an account
established on behalf of a beneficiary
with the beneficiary's cash daily
benefit;
(ii) allowing the beneficiary to
access such account through debit
cards; and
(iii) accounting for withdrawals by
the beneficiary from such account.
(D) Primary payor rules for beneficiaries
who are enrolled in medicaid.--In the case of
an eligible beneficiary who is enrolled in
Medicaid, the following payment rules shall
apply:
(i) Institutionalized
beneficiary.--If the beneficiary is a
patient in a hospital, nursing
facility, intermediate care facility
for the mentally retarded, or an
institution for mental diseases, the
beneficiary shall retain an amount
equal to 5 percent of the beneficiary's
daily or weekly cash benefit (as
applicable) (which shall be in addition
to the amount of the beneficiary's
personal needs allowance provided under
Medicaid), and the remainder of such
benefit shall be applied toward the
facility's cost of providing the
beneficiary's care, and Medicaid shall
provide secondary coverage for such
care.
(ii) Beneficiaries receiving home
and community-based services.--
(I) 50 percent of benefit
retained by beneficiary.--
Subject to subclause (II), if a
beneficiary is receiving
medical assistance under
Medicaid for home and community
based services, the beneficiary
shall retain an amount equal to
50 percent of the beneficiary's
daily or weekly cash benefit
(as applicable), and the
remainder of the daily or
weekly cash benefit shall be
applied toward the cost to the
State of providing such
assistance (and shall not be
used to claim Federal matching
funds under Medicaid), and
Medicaid shall provide
secondary coverage for the
remainder of any costs incurred
in providing such assistance.
(II) Requirement for state
offset.--A State shall be paid
the remainder of a
beneficiary's daily or weekly
cash benefit under subclause
(I) only if the State home and
community-based waiver under
section 1115 of the Social
Security Act (42 U.S.C. 1315)
or subsection (c) or (d) of
section 1915 of such Act (42
U.S.C. 1396n), or the State
plan amendment under subsection
(i) of such section does not
include a waiver of the
requirements of section
1902(a)(1) of the Social
Security Act (relating to
statewideness) or of section
1902(a)(10)(B) of such Act
(relating to comparability) and
the State offers at a minimum
case management services,
personal care services,
habilitation services, and
respite care under such a
waiver or State plan amendment.
(III) Definition of home
and community-based services.--
In this clause, the term ``home
and community-based services''
means any services which may be
offered under a home and
community-based waiver
authorized for a State under
section 1115 of the Social
Security Act (42 U.S.C. 1315)
or subsection (c) or (d) of
section 1915 of such Act (42
U.S.C. 1396n) or under a State
plan amendment under subsection
(i) of such section.
(iii) Beneficiaries enrolled in
programs of all-inclusive care for the
elderly (pace).--
(I) In general.--Subject to
subclause (II), if a
beneficiary is receiving
medical assistance under
Medicaid for PACE program
services under section 1934 of
the Social Security Act (42
U.S.C. 1396u-4), the
beneficiary shall retain an
amount equal to 50 percent of
the beneficiary's daily or
weekly cash benefit (as
applicable), and the remainder
of the daily or weekly cash
benefit shall be applied toward
the cost to the State of
providing such assistance (and
shall not be used to claim
Federal matching funds under
Medicaid), and Medicaid shall
provide secondary coverage for
the remainder of any costs
incurred in providing such
assistance.
(II) Institutionalized
recipients of pace program
services.--If a beneficiary
receiving assistance under
Medicaid for PACE program
services is a patient in a
hospital, nursing facility,
intermediate care facility for
the mentally retarded, or an
institution for mental
diseases, the beneficiary shall
be treated as in
institutionalized beneficiary
under clause (i).
(2) Authorized representatives.--
(A) In general.--The Secretary shall
establish procedures to allow access to a
beneficiary's cash benefits by an authorized
representative of the eligible beneficiary on
whose behalf such benefits are paid.
(B) Quality assurance and protection
against fraud and abuse.--The procedures
established under subparagraph (A) shall ensure
that authorized representatives of eligible
beneficiaries comply with standards of conduct
established by the Secretary, including
standards requiring that such representatives
provide quality services on behalf of such
beneficiaries, do not have conflicts of
interest, and do not misuse benefits paid on
behalf of such beneficiaries or otherwise
engage in fraud or abuse.
(3) Commencement of benefits.--Benefits shall be
paid to, or on behalf of, an eligible beneficiary
beginning with the first month in which an application
for such benefits is approved.
(4) Rollover option for lump-sum payment.--An
eligible beneficiary may elect to--
(A) defer payment of their daily or weekly
benefit and to rollover any such deferred
benefits from month-to-month, but not from
year-to-year; and
(B) receive a lump-sum payment of such
deferred benefits in an amount that may not
exceed the lesser of--
(i) the total amount of the accrued
deferred benefits; or
(ii) the applicable annual benefit.
(5) Period for determination of annual benefits.--
(A) In general.--The applicable period for
determining with respect to an eligible
beneficiary the applicable annual benefit and
the amount of any accrued deferred benefits is
the 12-month period that commences with the
first month in which the beneficiary began to
receive such benefits, and each 12-month period
thereafter.
(B) Inclusion of increased benefits.--The
Secretary shall establish procedures under
which cash benefits paid to an eligible
beneficiary that increase or decrease as a
result of a change in the functional status of
the beneficiary before the end of a 12-month
benefit period shall be included in the
determination of the applicable annual benefit
paid to the eligible beneficiary.
(C) Recoupment of unpaid, accrued
benefits.--
(i) In general.--The Secretary, in
coordination with the Secretary of the
Treasury, shall recoup any accrued
benefits in the event of--
(I) the death of a
beneficiary; or
(II) the failure of a
beneficiary to elect under
paragraph (4)(B) to receive
such benefits as a lump-sum
payment before the end of the
12-month period in which such
benefits accrued.
(ii) Payment into class
independence fund.--Any benefits
recouped in accordance with clause (i)
shall be paid into the CLASS
Independence Fund and used in
accordance with section 3206.
(6) Requirement to recertify eligibility for
receipt of benefits.--An eligible beneficiary shall
periodically, as determined by the Secretary--
(A) recertify by submission of medical
evidence the beneficiary's continued
eligibility for receipt of benefits; and
(B) submit records of expenditures
attributable to the aggregate cash benefit
received by the beneficiary during the
preceding year.
(7) Supplement, not supplant other health care
benefits.--Subject to the Medicaid payment rules under
paragraph (1)(D), benefits received by an eligible
beneficiary shall supplement, but not supplant, other
health care benefits for which the beneficiary is
eligible under Medicaid or any other Federally funded
program that provides health care benefits or
assistance.
(d) Advocacy Services.--An agreement entered into under
subsection (a)(2)(A)(ii) shall require the Protection and
Advocacy System for the State to--
(1) assign, as needed, an advocacy counselor to
each eligible beneficiary that is covered by such
agreement and who shall provide an eligible beneficiary
with--
(A) information regarding how to access the
appeals process established for the program;
(B) assistance with respect to the annual
recertification and notification required under
subsection (c)(6); and
(C) such other assistance with obtaining
services as the Secretary, by regulation, shall
require; and
(2) ensure that the System and such counselors
comply with the requirements of subsection (h).
(e) Advice and Assistance Counseling.--An agreement entered
into under subsection (a)(2)(A)(iii) shall require the entity
to assign, as requested by an eligible beneficiary that is
covered by such agreement, an advice and assistance counselor
who shall provide an eligible beneficiary with information
regarding--
(1) accessing and coordinating long-term services
and supports in the most integrated setting;
(2) possible eligibility for other benefits and
services;
(3) development of a service and support plan;
(4) information about programs established under
the Assistive Technology Act of 1998 and the services
offered under such programs;
(5) available assistance with decision making
concerning medical care, including the right to accept
or refuse medical or surgical treatment and the right
to formulate advance directives or other written
instructions recognized under State law, such as a
living will or durable power of attorney for health
care, in the case that an injury or illness causes the
individual to be unable to make health care decisions;
and
(6) such other services as the Secretary, by
regulation, may require.
(f) No Effect on Eligibility for Other Benefits.--Benefits
paid to an eligible beneficiary under the CLASS program shall
be disregarded for purposes of determining or continuing the
beneficiary's eligibility for receipt of benefits under any
other Federal, State, or locally funded assistance program,
including benefits paid under titles II, XVI, XVIII, XIX, or
XXI of the Social Security Act (42 U.S.C. 401 et seq., 1381 et
seq., 1395 et seq., 1396 et seq., 1397aa et seq.), under the
laws administered by the Secretary of Veterans Affairs, under
low-income housing assistance programs, or under the
supplemental nutrition assistance program established under the
Food and Nutrition Act of 2008 (7 U.S.C. 2011 et seq.).
(g) Rule of Construction.--Nothing in this title shall be
construed as prohibiting benefits paid under the CLASS
Independence Benefit Plan from being used to compensate a
family caregiver for providing community living assistance
services and supports to an eligible beneficiary.
(h) Protection Against Conflict of Interests.--The
Secretary shall establish procedures to ensure that the
Eligibility Assessment System, the Protection and Advocacy
System for a State, advocacy counselors for eligible
beneficiaries, and any other entities that provide services to
active enrollees and eligible beneficiaries under the CLASS
program comply with the following:
(1) If the entity provides counseling or planning
services, such services are provided in a manner that
fosters the best interests of the active enrollee or
beneficiary.
(2) The entity has established operating procedures
that are designed to avoid or minimize conflicts of
interest between the entity and an active enrollee or
beneficiary.
(3) The entity provides information about all
services and options available to the active enrollee
or beneficiary, to the best of its knowledge, including
services available through other entities or providers.
(4) The entity assists the active enrollee or
beneficiary to access desired services, regardless of
the provider.
(5) The entity reports the number of active
enrollees and beneficiaries provided with assistance by
age, disability, and whether such enrollees and
beneficiaries received services from the entity or
another entity.
(6) If the entity provides counseling or planning
services, the entity ensures that an active enrollee or
beneficiary is informed of any financial interest that
the entity has in a service provider.
(7) The entity provides an active enrollee or
beneficiary with a list of available service providers
that can meet the needs of the active enrollee or
beneficiary.
SEC. 3206. [300LL-5] CLASS INDEPENDENCE FUND.
(a) Establishment of CLASS Independence Fund.--There is
established in the Treasury of the United States a trust fund
to be known as the `CLASS Independence Fund'. The Secretary of
the Treasury shall serve as Managing Trustee of such Fund. The
Fund shall consist of all amounts derived from payments into
the Fund under sections 3204(f) and 3205(c)(5)(C)(ii), and
remaining after investment of such amounts under subsection
(b), including additional amounts derived as income from such
investments. The amounts held in the Fund are appropriated and
shall remain available without fiscal year limitation--
(1) to be held for investment on behalf of
individuals enrolled in the CLASS program;
(2) to pay the administrative expenses related to
the Fund and to investment under subsection (b); and
(3) to pay cash benefits to eligible beneficiaries
under the CLASS Independence Benefit Plan.
(b) Investment of Fund Balance.--The Secretary of the
Treasury shall invest and manage the CLASS Independence Fund in
the same manner, and to the same extent, as the Federal
Supplementary Medical Insurance Trust Fund may be invested and
managed under subsections (c), (d), and (e) of section 1841(d)
of the Social Security Act (42 U.S.C. 1395t).
(c) Board of Trustees.--
(1) In general.--With respect to the CLASS
Independence Fund, there is hereby created a body to be
known as the Board of Trustees of the CLASS
Independence Fund (hereinafter in this section referred
to as the ``Board of Trustees'') composed of the
Secretary of the Treasury, the Secretary of Labor, and
the Secretary of Health and Human Services, all ex
officio, and of two members of the public (both of whom
may not be from the same political party), who shall be
nominated by the President for a term of 4 years and
subject to confirmation by the Senate. A member of the
Board of Trustees serving as a member of the public and
nominated and confirmed to fill a vacancy occurring
during a term shall be nominated and confirmed only for
the remainder of such term. An individual nominated and
confirmed as a member of the public may serve in such
position after the expiration of such member's term
until the earlier of the time at which the member's
successor takes office or the time at which a report of
the Board is first issued under paragraph (2) after the
expiration of the member's term. The Secretary of the
Treasury shall be the Managing Trustee of the Board of
Trustees. The Board of Trustees shall meet not less
frequently than once each calendar year. A person
serving on the Board of Trustees shall not be
considered to be a fiduciary and shall not be
personally liable for actions taken in such capacity
with respect to the Trust Fund.
(2) Duties.--
(A) In general.--It shall be the duty of
the Board of Trustees to do the following:
(i) Hold the CLASS Independence
Fund.
(ii) Report to the Congress not
later than the first day of April of
each year on the operation and status
of the CLASS Independence Fund during
the preceding fiscal year and on its
expected operation and status during
the current fiscal year and the next 2
fiscal years.
(iii) Report immediately to the
Congress whenever the Board is of the
opinion that the amount of the CLASS
Independence Fund is not actuarially
sound in regards to the projection
under section 3203(b)(1)(B)(i).
(iv) Review the general policies
followed in managing the CLASS
Independence Fund, and recommend
changes in such policies, including
necessary changes in the provisions of
law which govern the way in which the
CLASS Independence Fund is to be
managed.
(B) Report.--The report provided for in
subparagraph (A)(ii) shall--
(i) include--
(I) a statement of the
assets of, and the
disbursements made from, the
CLASS Independence Fund during
the preceding fiscal year;
(II) an estimate of the
expected income to, and
disbursements to be made from,
the CLASS Independence Fund
during the current fiscal year
and each of the next 2 fiscal
years;
(III) a statement of the
actuarial status of the CLASS
Independence Fund for the
current fiscal year, each of
the next 2 fiscal years, and as
projected over the 75-year
period beginning with the
current fiscal year; and
(IV) an actuarial opinion
by the Chief Actuary of the
Centers for Medicare & Medicaid
Services certifying that the
techniques and methodologies
used are generally accepted
within the actuarial profession
and that the assumptions and
cost estimates used are
reasonable; and
(ii) be printed as a House document
of the session of the Congress to which
the report is made.
(C) Recommendations.--If the Board of
Trustees determines that enrollment trends and
expected future benefit claims on the CLASS
Independence Fund are not actuarially sound in
regards to the projection under section
3203(b)(1)(B)(i) and are unlikely to be
resolved with reasonable premium increases or
through other means, the Board of Trustees
shall include in the report provided for in
subparagraph (A)(ii) recommendations for such
legislative action as the Board of Trustees
determine to be appropriate, including whether
to adjust monthly premiums or impose a
temporary moratorium on new enrollments.
SEC. 3207. [300LL-6] CLASS INDEPENDENCE ADVISORY COUNCIL.
(a) Establishment.--There is hereby created an Advisory
Committee to be known as the ``CLASS Independence Advisory
Council''.
(b) Membership.--
(1) In general.--The CLASS Independence Advisory
Council shall be composed of not more than 15
individuals, not otherwise in the employ of the United
States--
(A) who shall be appointed by the President
without regard to the civil service laws and
regulations; and
(B) a majority of whom shall be
representatives of individuals who participate
or are likely to participate in the CLASS
program, and shall include representatives of
older and younger workers, individuals with
disabilities, family caregivers of individuals
who require services and supports to maintain
their independence at home or in another
residential setting of their choice in the
community, individuals with expertise in long-
term care or disability insurance, actuarial
science, economics, and other relevant
disciplines, as determined by the Secretary.
(2) Terms.--
(A) In general.--The members of the CLASS
Independence Advisory Council shall serve
overlapping terms of 3 years (unless appointed
to fill a vacancy occurring prior to the
expiration of a term, in which case the
individual shall serve for the remainder of the
term).
(B) Limitation.--A member shall not be
eligible to serve for more than 2 consecutive
terms.
(3) Chair.--The President shall, from time to time,
appoint one of the members of the CLASS Independence
Advisory Council to serve as the Chair.
(c) Duties.--The CLASS Independence Advisory Council shall
advise the Secretary on matters of general policy in the
administration of the CLASS program established under this
title and in the formulation of regulations under this title
including with respect to--
(1) the development of the CLASS Independence
Benefit Plan under section 3203;
(2) the determination of monthly premiums under
such plan; and
(3) the financial solvency of the program.
(d) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.), other than section 14 of that Act, shall
apply to the CLASS Independence Advisory Council.
(e) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to the CLASS Independence Advisory Council
to carry out its duties under this section, such sums
as may be necessary for fiscal year 2011 and for each
fiscal year thereafter.
(2) Availability.--Any sums appropriated under the
authorization contained in this section shall remain
available, without fiscal year limitation, until
expended.
SEC. 3208. [300LL-7] SOLVENCY AND FISCAL INDEPENDENCE; REGULATIONS;
ANNUAL REPORT.
(a) Solvency.--The Secretary shall regularly consult with
the Board of Trustees of the CLASS Independence Fund and the
CLASS Independence Advisory Council, for purposes of ensuring
that enrollees premiums are adequate to ensure the financial
solvency of the CLASS program, both with respect to fiscal
years occurring in the near-term and fiscal years occurring
over 20- and 75-year periods, taking into account the
projections required for such periods under subsections
(a)(1)(A)(i) and (b)(1)(B)(i) of section 3202.
(b) No Taxpayer Funds Used To Pay Benefits.--No taxpayer
funds shall be used for payment of benefits under a CLASS
Independent Benefit Plan. For purposes of this subsection, the
term ``taxpayer funds'' means any Federal funds from a source
other than premiums deposited by CLASS program participants in
the CLASS Independence Fund and any associated interest
earnings.
(c) Regulations.--The Secretary shall promulgate such
regulations as are necessary to carry out the CLASS program in
accordance with this title. Such regulations shall include
provisions to prevent fraud and abuse under the program.
(d) Annual Report.--Beginning January 1, 2014, the
Secretary shall submit an annual report to Congress on the
CLASS program. Each report shall include the following:
(1) The total number of enrollees in the program.
(2) The total number of eligible beneficiaries
during the fiscal year.
(3) The total amount of cash benefits provided
during the fiscal year.
(4) A description of instances of fraud or abuse
identified during the fiscal year.
(5) Recommendations for such administrative or
legislative action as the Secretary determines is
necessary to improve the program, ensure the solvency
of the program, or to prevent the occurrence of fraud
or abuse.
SEC. 3209. [300LL-8] INSPECTOR GENERAL'S REPORT.
The Inspector General of the Department of Health and Human
Services shall submit an annual report to the Secretary and
Congress relating to the overall progress of the CLASS program
and of the existence of waste, fraud, and abuse in the CLASS
program. Each such report shall include findings in the
following areas:
(1) The eligibility determination process.
(2) The provision of cash benefits.
(3) Quality assurance and protection against waste,
fraud, and abuse.
(4) Recouping of unpaid and accrued benefits.
SEC. 3210. [300LL-9] TAX TREATMENT OF PROGRAM.
The CLASS program shall be treated for purposes of the
Internal Revenue Code of 1986 in the same manner as a qualified
long-term care insurance contract for qualified long-term care
services.
TITLE XXXIII--WORLD TRADE CENTER HEALTH PROGRAM
Subtitle A--Establishment of Program; Advisory Committee
SEC. 3301. ESTABLISHMENT OF WORLD TRADE CENTER HEALTH PROGRAM.
(a) In General.--There is hereby established within the
Department of Health and Human Services a program to be known
as the World Trade Center Health Program, which shall be
administered by the WTC Program Administrator, to provide
beginning on July 1, 2011--
(1) medical monitoring and treatment benefits to
eligible emergency responders and recovery and cleanup
workers (including those who are Federal employees) who
responded to the September 11, 2001, terrorist attacks;
and
(2) initial health evaluation, monitoring, and
treatment benefits to residents and other building
occupants and area workers in New York City who were
directly impacted and adversely affected by such
attacks.
(b) Components of Program.--The WTC Program includes the
following components:
(1) Medical monitoring for responders.--Medical
monitoring under section 3311, including clinical
examinations and long-term health monitoring and
analysis for enrolled WTC responders who were likely to
have been exposed to airborne toxins that were
released, or to other hazards, as a result of the
September 11, 2001, terrorist attacks.
(2) Initial health evaluation for survivors.--An
initial health evaluation under section 3321, including
an evaluation to determine eligibility for followup
monitoring and treatment.
(3) Followup monitoring and treatment for wtc-
related health conditions for responders and
survivors.--Provision under sections 3312, 3322, and
3323 of followup monitoring and treatment and payment,
subject to the provisions of subsection (d), for all
medically necessary health and mental health care
expenses of an individual with respect to a WTC-related
health condition (including necessary prescription
drugs).
(4) Outreach.--Establishment under section 3303 of
an education and outreach program to potentially
eligible individuals concerning the benefits under this
title.
(5) Clinical data collection and analysis.--
Collection and analysis under section 3304 of health
and mental health data relating to individuals
receiving monitoring or treatment benefits in a uniform
manner in collaboration with the collection of
epidemiological data under section 3342.
(6) Research on health conditions.--Establishment
under subtitle C of a research program on health
conditions resulting from the September 11, 2001,
terrorist attacks.
(c) No Cost Sharing.--Monitoring and treatment benefits and
initial health evaluation benefits are provided under subtitle
B without any deductibles, copayments, or other cost sharing to
an enrolled WTC responder or certified-eligible WTC survivor.
Initial health evaluation benefits are provided under subtitle
B without any deductibles, copayments, or other cost sharing to
a screening-eligible WTC survivor.
(d) Preventing Fraud and Unreasonable Administrative
Costs.--
(1) Fraud.--The Inspector General of the Department
of Health and Human Services shall develop and
implement a program to review the WTC Program's health
care expenditures to detect fraudulent or duplicate
billing and payment for inappropriate services. This
title is a Federal health care program (as defined in
section 1128B(f) of the Social Security Act) and is a
health plan (as defined in section 1128C(c) of such
Act) for purposes of applying sections 1128 through
1128E of such Act.
(2) Unreasonable administrative costs.--The
Inspector General of the Department of Health and Human
Services shall develop and implement a program to
review the WTC Program for unreasonable administrative
costs, including with respect to infrastructure,
administration, and claims processing.
(e) Quality Assurance.--The WTC Program Administrator
working with the Clinical Centers of Excellence shall develop
and implement a quality assurance program for the monitoring
and treatment delivered by such Centers of Excellence and any
other participating health care providers. Such program shall
include--
(1) adherence to monitoring and treatment
protocols;
(2) appropriate diagnostic and treatment referrals
for participants;
(3) prompt communication of test results to
participants; and
(4) such other elements as the Administrator
specifies in consultation with the Clinical Centers of
Excellence.
(f) Annual Program Report.--
(1) In general.--Not later than 6 months after the
end of each fiscal year in which the WTC Program is in
operation, the WTC Program Administrator shall submit
an annual report to the Congress on the operations of
this title for such fiscal year and for the entire
period of operation of the program.
(2) Contents included in report.--Each annual
report under paragraph (1) shall include at least the
following:
(A) Eligible individuals.--Information for
each clinical program described in paragraph
(3)--
(i) on the number of individuals
who applied for certification under
subtitle B and the number of such
individuals who were so certified;
(ii) of the individuals who were
certified, on the number who received
monitoring under the program and the
number of such individuals who received
medical treatment under the program;
(iii) with respect to individuals
so certified who received such
treatment, on the WTC-related health
conditions for which they were treated;
and
(iv) on the projected number of
individuals who will be certified under
subtitle B in the succeeding fiscal
year and the succeeding 10-year period.
(B) Monitoring, initial health evaluation,
and treatment costs.--For each clinical program
so described--
(i) information on the costs of
monitoring and initial health
evaluation and the costs of treatment
and on the estimated costs of such
monitoring, evaluation, and treatment
in the succeeding fiscal year; and
(ii) an estimate of the cost of
medical treatment for WTC-related
health conditions that have been paid
for or reimbursed by workers'
compensation, by public or private
health plans, or by New York City under
section 3331.
(C) Administrative costs.--Information on
the cost of administering the program,
including costs of program support, data
collection and analysis, and research conducted
under the program.
(D) Administrative experience.--Information
on the administrative performance of the
program, including--
(i) the performance of the program
in providing timely evaluation of and
treatment to eligible individuals; and
(ii) a list of the Clinical Centers
of Excellence and other providers that
are participating in the program.
(E) Scientific reports.--A summary of the
findings of any new scientific reports or
studies on the health effects associated with
exposure described in section 3306(1),
including the findings of research conducted
under section 3341(a).
(F) Advisory committee recommendations.--A
list of recommendations by the WTC Scientific/
Technical Advisory Committee on additional WTC
Program eligibility criteria and on additional
WTC-related health conditions and the action of
the WTC Program Administrator concerning each
such recommendation.
(3) Separate clinical programs described.--In
paragraph (2), each of the following shall be treated
as a separate clinical program of the WTC Program:
(A) Firefighters and related personnel.--
The benefits provided for enrolled WTC
responders described in section 3311(a)(2)(A).
(B) Other wtc responders.--The benefits
provided for enrolled WTC responders not
described in subparagraph (A).
(C) WTC survivors.--The benefits provided
for screening-eligible WTC survivors and
certified-eligible WTC survivors in section
3321(a).
(g) Notification to Congress Upon Reaching 80 Percent of
Eligibility Numerical Limits.--The Secretary shall promptly
notify the Congress of each of the following:
(1) When the number of enrollments of WTC
responders subject to the limit established under
section 3311(a)(4) has reached 80 percent of such
limit.
(2) When the number of certifications for
certified-eligible WTC survivors subject to the limit
established under section 3321(a)(3) has reached 80
percent of such limit.
(h) Consultation.--The WTC Program Administrator shall
engage in ongoing outreach and consultation with relevant
stakeholders, including the WTC Health Program Steering
Committees and the Advisory Committee under section 3302,
regarding the implementation and improvement of programs under
this title.
SEC. 3302. WTC HEALTH PROGRAM SCIENTIFIC/TECHNICAL ADVISORY COMMITTEE;
WTC HEALTH PROGRAM STEERING COMMITTEES.
(a) Advisory Committee.--
(1) Establishment.--The WTC Program Administrator
shall establish an advisory committee to be known as
the WTC Health Program Scientific/Technical Advisory
Committee (in this subsection referred to as the
``Advisory Committee'') to review scientific and
medical evidence and to make recommendations to the
Administrator on additional WTC Program eligibility
criteria and on additional WTC-related health
conditions.
(2) Composition.--The WTC Program Administrator
shall appoint the members of the Advisory Committee and
shall include at least--
(A) 4 occupational physicians, at least 2
of whom have experience treating WTC rescue and
recovery workers;
(B) 1 physician with expertise in pulmonary
medicine;
(C) 2 environmental medicine or
environmental health specialists;
(D) 2 representatives of WTC responders;
(E) 2 representatives of certified-eligible
WTC survivors;
(F) an industrial hygienist;
(G) a toxicologist;
(H) an epidemiologist; and
(I) a mental health professional.
(3) Meetings.--The Advisory Committee shall meet at
such frequency as may be required to carry out its
duties.
(4) Reports.--The WTC Program Administrator shall
provide for publication of recommendations of the
Advisory Committee on the public Web site established
for the WTC Program.
(5) Duration.--Notwithstanding any other provision
of law, the Advisory Committee shall continue in
operation during the period in which the WTC Program is
in operation.
(6) Application of faca.--Except as otherwise
specifically provided, the Advisory Committee shall be
subject to the Federal Advisory Committee Act.
(b) WTC Health Program Steering Committees.--
(1) Consultation.--The WTC Program Administrator
shall consult with 2 steering committees (each in this
section referred to as a ``Steering Committee'') that
are established as follows:
(A) WTC responders steering committee.--One
Steering Committee, to be known as the WTC
Responders Steering Committee, for the purpose
of receiving input from affected stakeholders
and facilitating the coordination of monitoring
and treatment programs for the enrolled WTC
responders under part 1 of subtitle B.
(B) WTC survivors steering committee.--One
Steering Committee, to be known as the WTC
Survivors Steering Committee, for the purpose
of receiving input from affected stakeholders
and facilitating the coordination of initial
health evaluations, monitoring, and treatment
programs for screening-eligible and certified-
eligible WTC survivors under part 2 of subtitle
B.
(2) Membership.--
(A) WTC responders steering committee.--
(i) Representation.--The WTC
Responders Steering Committee shall
include--
(I) representatives of the
Centers of Excellence providing
services to WTC responders;
(II) representatives of
labor organizations
representing firefighters,
police, other New York City
employees, and recovery and
cleanup workers who responded
to the September 11, 2001,
terrorist attacks; and
(III) 3 representatives of
New York City, 1 of whom will
be selected by the police
commissioner of New York City,
1 by the health commissioner of
New York City, and 1 by the
mayor of New York City.
(ii) Initial membership.--The WTC
Responders Steering Committee shall
initially be composed of members of the
WTC Monitoring and Treatment Program
Steering Committee (as in existence on
the day before the date of the
enactment of this title).
(B) WTC survivors steering committee.--
(i) Representation.--The WTC
Survivors Steering Committee shall
include representatives of--
(I) the Centers of
Excellence providing services
to screening-eligible and
certified-eligible WTC
survivors;
(II) the population of
residents, students, and area
and other workers affected by
the September 11, 2001,
terrorist attacks;
(III) screening-eligible
and certified-eligible
survivors receiving initial
health evaluations, monitoring,
or treatment under part 2 of
subtitle B and organizations
advocating on their behalf; and
(IV) New York City.
(ii) Initial membership.--The WTC
Survivors Steering Committee shall
initially be composed of members of the
WTC Environmental Health Center
Survivor Advisory Committee (as in
existence on the day before the date of
the enactment of this title).
(C) Additional appointments.--Each Steering
Committee may recommend, if approved by a
majority of voting members of the Committee,
additional members to the Committee.
(D) Vacancies.--A vacancy in a Steering
Committee shall be filled by an individual
recommended by the Steering Committee.
SEC. 3303. EDUCATION AND OUTREACH.
The WTC Program Administrator shall institute a program
that provides education and outreach on the existence and
availability of services under the WTC Program. The outreach
and education program--
(1) shall include--
(A) the establishment of a public Web site
with information about the WTC Program;
(B) meetings with potentially eligible
populations;
(C) development and dissemination of
outreach materials informing people about the
program; and
(D) the establishment of phone information
services; and
(2) shall be conducted in a manner intended--
(A) to reach all affected populations; and
(B) to include materials for culturally and
linguistically diverse populations.
SEC. 3304. UNIFORM DATA COLLECTION AND ANALYSIS.
(a) In General.--The WTC Program Administrator shall
provide for the uniform collection of data, including claims
data (and analysis of data and regular reports to the
Administrator) on the prevalence of WTC-related health
conditions and the identification of new WTC-related health
conditions. Such data shall be collected for all individuals
provided monitoring or treatment benefits under subtitle B and
regardless of their place of residence or Clinical Center of
Excellence through which the benefits are provided. The WTC
Program Administrator shall provide, through the Data Centers
or otherwise, for the integration of such data into the
monitoring and treatment program activities under this title.
(b) Coordinating Through Centers of Excellence.--Each
Clinical Center of Excellence shall collect data described in
subsection (a) and report such data to the corresponding Data
Center for analysis by such Data Center.
(c) Collaboration With WTC Health Registry.--The WTC
Program Administrator shall provide for collaboration between
the Data Centers and the World Trade Center Health Registry
described in section 3342.
(d) Privacy.--The data collection and analysis under this
section shall be conducted and maintained in a manner that
protects the confidentiality of individually identifiable
health information consistent with applicable statutes and
regulations, including, as applicable, HIPAA privacy and
security law (as defined in section 3009(a)(2)) and section
552a of title 5, United States Code.
SEC. 3305. CLINICAL CENTERS OF EXCELLENCE AND DATA CENTERS.
(a) In General.--
(1) Contracts with clinical centers of
excellence.--The WTC Program Administrator shall,
subject to subsection (b)(1)(B), enter into contracts
with Clinical Centers of Excellence (as defined in
subsection (b)(1)(A))--
(A) for the provision of monitoring and
treatment benefits and initial health
evaluation benefits under subtitle B;
(B) for the provision of outreach
activities to individuals eligible for such
monitoring and treatment benefits, for initial
health evaluation benefits, and for followup to
individuals who are enrolled in the monitoring
program;
(C) for the provision of counseling for
benefits under subtitle B, with respect to WTC-
related health conditions, for individuals
eligible for such benefits;
(D) for the provision of counseling for
benefits for WTC-related health conditions that
may be available under workers' compensation or
other benefit programs for work-related
injuries or illnesses, health insurance,
disability insurance, or other insurance plans
or through public or private social service
agencies and assisting eligible individuals in
applying for such benefits;
(E) for the provision of translational and
interpretive services for program participants
who are not English language proficient; and
(F) for the collection and reporting of
data, including claims data, in accordance with
section 3304.
(2) Contracts with data centers.--
(A) In general.--The WTC Program
Administrator shall enter into contracts with
one or more Data Centers (as defined in
subsection (b)(2))--
(i) for receiving, analyzing, and
reporting to the WTC Program
Administrator on data, in accordance
with section 3304, that have been
collected and reported to such Data
Centers by the corresponding Clinical
Centers of Excellence under subsection
(b)(1)(B)(iii);
(ii) for the development of
monitoring, initial health evaluation,
and treatment protocols, with respect
to WTC-related health conditions;
(iii) for coordinating the outreach
activities conducted under paragraph
(1)(B) by each corresponding Clinical
Center of Excellence;
(iv) for establishing criteria for
the credentialing of medical providers
participating in the nationwide network
under section 3313;
(v) for coordinating and
administering the activities of the WTC
Health Program Steering Committees
established under section 3002(b); and
(vi) for meeting periodically with
the corresponding Clinical Centers of
Excellence to obtain input on the
analysis and reporting of data
collected under clause (i) and on the
development of monitoring, initial
health evaluation, and treatment
protocols under clause (ii).
(B) Medical provider selection.--The
medical providers under subparagraph (A)(iv)
shall be selected by the WTC Program
Administrator on the basis of their experience
treating or diagnosing the health conditions
included in the list of WTC-related health
conditions.
(C) Clinical discussions.--In carrying out
subparagraph (A)(ii), a Data Center shall
engage in clinical discussions across the WTC
Program to guide treatment approaches for
individuals with a WTC-related health
condition.
(D) Transparency of data.--A contract
entered into under this subsection with a Data
Center shall require the Data Center to make
any data collected and reported to such Center
under subsection (b)(1)(B)(iii) available to
health researchers and others as provided in
the CDC/ATSDR Policy on Releasing and Sharing
Data.
(3) Authority for contracts to be class specific.--
A contract entered into under this subsection with a
Clinical Center of Excellence or a Data Center may be
with respect to one or more class of enrolled WTC
responders, screening-eligible WTC survivors, or
certified-eligible WTC survivors.
(4) Use of cooperative agreements.--Any contract
under this title between the WTC Program Administrator
and a Data Center or a Clinical Center of Excellence
may be in the form of a cooperative agreement.
(5) Review on feasibility of consolidating data
centers.--Not later than July 1, 2011, the Comptroller
General of the United States shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report on the
feasibility of consolidating Data Centers into a single
Data Center.
(b) Centers of Excellence.--
(1) Clinical centers of excellence.--
(A) Definition.--For purposes of this
title, the term ``Clinical Center of
Excellence'' means a Center that demonstrates
to the satisfaction of the Administrator that
the Center--
(i) uses an integrated, centralized
health care provider approach to create
a comprehensive suite of health
services under this title that are
accessible to enrolled WTC responders,
screening-eligible WTC survivors, or
certified-eligible WTC survivors;
(ii) has experience in caring for
WTC responders and screening-eligible
WTC survivors or includes health care
providers who have been trained
pursuant to section 3313(c);
(iii) employs health care provider
staff with expertise that includes, at
a minimum, occupational medicine,
environmental medicine, trauma-related
psychiatry and psychology, and social
services counseling; and
(iv) meets such other requirements
as specified by the Administrator.
(B) Contract requirements.--The WTC Program
Administrator shall not enter into a contract
with a Clinical Center of Excellence under
subsection (a)(1) unless the Center agrees to
do each of the following:
(i) Establish a formal mechanism
for consulting with and receiving input
from representatives of eligible
populations receiving monitoring and
treatment benefits under subtitle B
from such Center.
(ii) Coordinate monitoring and
treatment benefits under subtitle B
with routine medical care provided for
the treatment of conditions other than
WTC-related health conditions.
(iii) Collect and report to the
corresponding Data Center data,
including claims data, in accordance
with section 3304(b).
(iv) Have in place safeguards
against fraud that are satisfactory to
the Administrator, in consultation with
the Inspector General of the Department
of Health and Human Services.
(v) Treat or refer for treatment
all individuals who are enrolled WTC
responders or certified-eligible WTC
survivors with respect to such Center
who present themselves for treatment of
a WTC-related health condition.
(vi) Have in place safeguards,
consistent with section 3304(c), to
ensure the confidentiality of an
individual's individually identifiable
health information, including requiring
that such information not be disclosed
to the individual's employer without
the authorization of the individual.
(vii) Use amounts paid under
subsection (c)(1) only for costs
incurred in carrying out the activities
described in subsection (a), other than
those described in subsection
(a)(1)(A).
(viii) Utilize health care
providers with occupational and
environmental medicine expertise to
conduct physical and mental health
assessments, in accordance with
protocols developed under subsection
(a)(2)(A)(ii).
(ix) Communicate with WTC
responders and screening-eligible and
certified-eligible WTC survivors in
appropriate languages and conduct
outreach activities with relevant
stakeholder worker or community
associations.
(x) Meet all the other applicable
requirements of this title, including
regulations implementing such
requirements.
(C) Transition rule to ensure continuity of
care.--The WTC Program Administrator shall to
the maximum extent feasible ensure continuity
of care in any period of transition from
monitoring and treatment of an enrolled WTC
responder or certified-eligible WTC survivor by
a provider to a Clinical Center of Excellence
or a health care provider participating in the
nationwide network under section 3313.
(2) Data centers.--For purposes of this title, the
term ``Data Center'' means a Center that the WTC
Program Administrator determines has the capacity to
carry out the responsibilities for a Data Center under
subsection (a)(2).
(3) Corresponding centers.--For purposes of this
title, a Clinical Center of Excellence and a Data
Center shall be treated as ``corresponding'' to the
extent that such Clinical Center and Data Center serve
the same population group.
(c) Payment for Infrastructure Costs.--
(1) In general.--The WTC Program Administrator
shall reimburse a Clinical Center of Excellence for the
fixed infrastructure costs of such Center in carrying
out the activities described in subtitle B at a rate
negotiated by the Administrator and such Centers. Such
negotiated rate shall be fair and appropriate and take
into account the number of enrolled WTC responders
receiving services from such Center under this title.
(2) Fixed infrastructure costs.--For purposes of
paragraph (1), the term ``fixed infrastructure costs''
means, with respect to a Clinical Center of Excellence,
the costs incurred by such Center that are not
otherwise reimbursable by the WTC Program Administrator
under section 3312(c) for patient evaluation,
monitoring, or treatment but which are needed to
operate the WTC program such as the costs involved in
outreach to participants or recruiting participants,
data collection and analysis, social services for
counseling patients on other available assistance
outside the WTC program, and the development of
treatment protocols. Such term does not include costs
for new construction or other capital costs.
(d) GAO Analysis.--Not later than July 1, 2011, the
Comptroller General shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate an
analysis on whether Clinical Centers of Excellence with which
the WTC Program Administrator enters into a contract under this
section have financial systems that will allow for the timely
submission of claims data for purposes of section 3304 and
subsections (a)(1)(F) and (b)(1)(B)(iii).
SEC. 3306. DEFINITIONS.
In this title:
(1) The term ``aggravating'' means, with respect to
a health condition, a health condition that existed on
September 11, 2001, and that, as a result of exposure
to airborne toxins, any other hazard, or any other
adverse condition resulting from the September 11,
2001, terrorist attacks, requires medical treatment
that is (or will be) in addition to, more frequent
than, or of longer duration than the medical treatment
that would have been required for such condition in the
absence of such exposure.
(2) The term ``certified-eligible WTC survivor''
has the meaning given such term in section 3321(a)(2).
(3) The terms ``Clinical Center of Excellence'' and
``Data Center'' have the meanings given such terms in
section 3305.
(4) The term ``enrolled WTC responder'' means a WTC
responder enrolled under section 3311(a)(3).
(5) The term ``initial health evaluation''
includes, with respect to an individual, a medical and
exposure history, a physical examination, and
additional medical testing as needed to evaluate
whether the individual has a WTC-related health
condition and is eligible for treatment under the WTC
Program.
(6) The term ``list of WTC-related health
conditions'' means--
(A) for WTC responders, the health
conditions listed in section 3312(a)(3); and
(B) for screening-eligible and certified-
eligible WTC survivors, the health conditions
listed in section 3322(b).
(7) The term ``New York City disaster area'' means
the area within New York City that is--
(A) the area of Manhattan that is south of
Houston Street; and
(B) any block in Brooklyn that is wholly or
partially contained within a 1.5-mile radius of
the former World Trade Center site.
(8) The term ``New York metropolitan area'' means
an area, specified by the WTC Program Administrator,
within which WTC responders and eligible WTC screening-
eligible survivors who reside in such area are
reasonably able to access monitoring and treatment
benefits and initial health evaluation benefits under
this title through a Clinical Center of Excellence
described in subparagraphs (A), (B), or (C) of section
3305(b)(1).
(9) The term ``screening-eligible WTC survivor''
has the meaning given such term in section 3321(a)(1).
(10) Any reference to ``September 11, 2001'' shall
be deemed a reference to the period on such date
subsequent to the terrorist attacks at the World Trade
Center, Shanksville, Pennsylvania, or the Pentagon, as
applicable, on such date.
(11) The term ``September 11, 2001, terrorist
attacks'' means the terrorist attacks that occurred on
September 11, 2001, in New York City, in Shanksville,
Pennsylvania, and at the Pentagon, and includes the
aftermath of such attacks.
(12) The term ``WTC Health Program Steering
Committee'' means such a Steering Committee established
under section 3302(b).
(13) The term ``WTC Program'' means the Word Trade
Center Health Program established under section
3301(a).
(14)(A) The term ``WTC Program Administrator''
means--
(i) subject to subparagraph (B), with
respect to paragraphs (3) and (4) of section
3311(a) (relating to enrollment of WTC
responders), section 3312(c) and the
corresponding provisions of section 3322
(relating to payment for initial health
evaluation, monitoring, and treatment,
paragraphs (1)(C), (2)(B), and (3) of section
3321(a) (relating to determination or
certification of screening-eligible or
certified-eligible WTC responders), and part 3
of subtitle B (relating to payor provisions),
an official in the Department of Health and
Human Services, to be designated by the
Secretary; and
(ii) with respect to any other provision of
this title, the Director of the National
Institute for Occupational Safety and Health,
or a designee of such Director.
(B) In no case may the Secretary designate under
subparagraph (A)(i) the Director of the National
Institute for Occupational Safety and Health or a
designee of such Director with respect to section 3322
(relating to payment for initial health evaluation,
monitoring, and treatment).
(15) The term ``WTC-related health condition'' is
defined in section 3312(a).
(16) The term ``WTC responder'' is defined in
section 3311(a).
(17) The term ``WTC Scientific/Technical Advisory
Committee'' means such Committee established under
section 3302(a).
Subtitle B--Program of Monitoring, Initial Health Evaluations, and
Treatment
PART 1--WTC RESPONDERS
SEC. 3311. IDENTIFICATION OF WTC RESPONDERS AND PROVISION OF WTC-
RELATED MONITORING SERVICES.
(a) WTC Responder Defined.--
(1) In general.--For purposes of this title, the
term ``WTC responder'' means any of the following
individuals, subject to paragraph (4):
(A) Currently identified responder.--An
individual who has been identified as eligible
for monitoring under the arrangements as in
effect on the date of the enactment of this
title between the National Institute for
Occupational Safety and Health and--
(i) the consortium coordinated by
Mt. Sinai Hospital in New York City
that coordinates the monitoring and
treatment for enrolled WTC responders
other than with respect to those
covered under the arrangement with the
Fire Department of New York City; or
(ii) the Fire Department of New
York City.
(B) Responder who meets current eligibility
criteria.--An individual who meets the current
eligibility criteria described in paragraph
(2).
(C) Responder who meets modified
eligibility criteria.--An individual who--
(i) performed rescue, recovery,
demolition, debris cleanup, or other
related services in the New York City
disaster area in response to the
September 11, 2001, terrorist attacks,
regardless of whether such services
were performed by a State or Federal
employee or member of the National
Guard or otherwise; and
(ii) meets such eligibility
criteria relating to exposure to
airborne toxins, other hazards, or
adverse conditions resulting from the
September 11, 2001, terrorist attacks
as the WTC Program Administrator, after
consultation with the WTC Scientific/
Technical Advisory Committee,
determines appropriate.
The WTC Program Administrator shall not modify
such eligibility criteria on or after the date
that the number of enrollments of WTC
responders has reached 80 percent of the limit
described in paragraph (4) or on or after the
date that the number of certifications for
certified-eligible WTC survivors under section
3321(a)(2)(B) has reached 80 percent of the
limit described in section 3321(a)(3).
(2) Current eligibility criteria.--The eligibility
criteria described in this paragraph for an individual
is that the individual is described in any of the
following categories:
(A) Firefighters and related personnel.--
The individual--
(i) was a member of the Fire
Department of New York City (whether
fire or emergency personnel, active or
retired) who participated at least one
day in the rescue and recovery effort
at any of the former World Trade Center
sites (including Ground Zero, Staten
Island Landfill, and the New York City
Chief Medical Examiner's Office) for
any time during the period beginning on
September 11, 2001, and ending on July
31, 2002; or
(ii)(I) is a surviving immediate
family member of an individual who was
a member of the Fire Department of New
York City (whether fire or emergency
personnel, active or retired) and was
killed at the World Trade site on
September 11, 2001; and
(II) received any treatment for a
WTC-related health condition described
in section 3312(a)(1)(A)(ii) (relating
to mental health conditions) on or
before September 1, 2008.
(B) Law enforcement officers and wtc
rescue, recovery, and cleanup workers.--The
individual--
(i) worked or volunteered onsite in
rescue, recovery, debris cleanup, or
related support services in lower
Manhattan (south of Canal St.), the
Staten Island Landfill, or the barge
loading piers, for at least 4 hours
during the period beginning on
September 11, 2001, and ending on
September 14, 2001, for at least 24
hours during the period beginning on
September 11, 2001, and ending on
September 30, 2001, or for at least 80
hours during the period beginning on
September 11, 2001, and ending on July
31, 2002;
(ii)(I) was a member of the Police
Department of New York City (whether
active or retired) or a member of the
Port Authority Police of the Port
Authority of New York and New Jersey
(whether active or retired) who
participated onsite in rescue,
recovery, debris cleanup, or related
services in lower Manhattan (south of
Canal St.), including Ground Zero, the
Staten Island Landfill, or the barge
loading piers, for at least 4 hours
during the period beginning September
11, 2001, and ending on September 14,
2001;
(II) participated onsite in rescue,
recovery, debris cleanup, or related
services at Ground Zero, the Staten
Island Landfill, or the barge loading
piers, for at least one day during the
period beginning on September 11, 2001,
and ending on July 31, 2002;
(III) participated onsite in
rescue, recovery, debris cleanup, or
related services in lower Manhattan
(south of Canal St.) for at least 24
hours during the period beginning on
September 11, 2001, and ending on
September 30, 2001; or
(IV) participated onsite in rescue,
recovery, debris cleanup, or related
services in lower Manhattan (south of
Canal St.) for at least 80 hours during
the period beginning on September 11,
2001, and ending on July 31, 2002;
(iii) was an employee of the Office
of the Chief Medical Examiner of New
York City involved in the examination
and handling of human remains from the
World Trade Center attacks, or other
morgue worker who performed similar
post-September 11 functions for such
Office staff, during the period
beginning on September 11, 2001, and
ending on July 31, 2002;
(iv) was a worker in the Port
Authority Trans-Hudson Corporation
Tunnel for at least 24 hours during the
period beginning on February 1, 2002,
and ending on July 1, 2002; or
(v) was a vehicle-maintenance
worker who was exposed to debris from
the former World Trade Center while
retrieving, driving, cleaning,
repairing, and maintaining vehicles
contaminated by airborne toxins from
the September 11, 2001, terrorist
attacks during a duration and period
described in subparagraph (A).
(C) Responders to the september 11 attacks
at the pentagon and shanksville,
pennsylvania.--The individual--
(i)(I) was a member of a fire or
police department (whether fire or
emergency personnel, active or
retired), worked for a recovery or
cleanup contractor, or was a volunteer;
and performed rescue, recovery,
demolition, debris cleanup, or other
related services at the Pentagon site
of the terrorist-related aircraft crash
of September 11, 2001, during the
period beginning on September 11, 2001,
and ending on the date on which the
cleanup of the site was concluded, as
determined by the WTC Program
Administrator; or
(II) was a member of a fire or
police department (whether fire or
emergency personnel, active or
retired), worked for a recovery or
cleanup contractor, or was a volunteer;
and performed rescue, recovery,
demolition, debris cleanup, or other
related services at the Shanksville,
Pennsylvania, site of the terrorist-
related aircraft crash of September 11,
2001, during the period beginning on
September 11, 2001, and ending on the
date on which the cleanup of the site
was concluded, as determined by the WTC
Program Administrator; and
(ii) is determined by the WTC
Program Administrator to be at an
increased risk of developing a WTC-
related health condition as a result of
exposure to airborne toxins, other
hazards, or adverse conditions
resulting from the September 11, 2001,
terrorist attacks, and meets such
eligibility criteria related to such
exposures, as the WTC Program
Administrator determines are
appropriate, after consultation with
the WTC Scientific/Technical Advisory
Committee.
(3) Enrollment process.--
(A) In general.--The WTC Program
Administrator shall establish a process for
enrolling WTC responders in the WTC Program.
Under such process--
(i) WTC responders described in
paragraph (1)(A) shall be deemed to be
enrolled in such Program;
(ii) subject to clause (iii), the
Administrator shall enroll in such
program individuals who are determined
to be WTC responders;
(iii) the Administrator shall deny
such enrollment to an individual if the
Administrator determines that the
numerical limitation in paragraph (4)
on enrollment of WTC responders has
been met;
(iv) there shall be no fee charged
to the applicant for making an
application for such enrollment;
(v) the Administrator shall make a
determination on such an application
not later than 60 days after the date
of filing the application; and
(vi) an individual who is denied
enrollment in such Program shall have
an opportunity to appeal such
determination in a manner established
under such process.
(B) Timing.--
(i) Currently identified
responders.--In accordance with
subparagraph (A)(i), the WTC Program
Administrator shall enroll an
individual described in paragraph
(1)(A) in the WTC Program not later
than July 1, 2011.
(ii) Other responders.--In
accordance with subparagraph (A)(ii)
and consistent with paragraph (4), the
WTC Program Administrator shall enroll
any other individual who is determined
to be a WTC responder in the WTC
Program at the time of such
determination.
(4) Numerical limitation on eligible wtc
responders.--
(A) In general.--The total number of
individuals not described in paragraph (1)(A)
or (2)(A)(ii) who may be enrolled under
paragraph (3)(A)(ii) shall not exceed 25,000 at
any time, of which no more than 2,500 may be
individuals enrolled based on modified
eligibility criteria established under
paragraph (1)(C).
(B) Process.--In implementing subparagraph
(A), the WTC Program Administrator shall--
(i) limit the number of enrollments
made under paragraph (3)--
(I) in accordance with such
subparagraph; and
(II) to such number, as
determined by the Administrator
based on the best available
information and subject to
amounts available under section
3351, that will ensure
sufficient funds will be
available to provide treatment
and monitoring benefits under
this title, with respect to all
individuals who are enrolled
through the end of fiscal year
2020; and
(ii) provide priority (subject to
paragraph (3)(A)(i)) in such
enrollments in the order in which
individuals apply for enrollment under
paragraph (3).
(5) Disqualification of individuals on terrorist
watch list.--No individual who is on the terrorist
watch list maintained by the Department of Homeland
Security shall qualify as an eligible WTC responder.
Before enrolling any individual as a WTC responder in
the WTC Program under paragraph (3), the Administrator,
in consultation with the Secretary of Homeland
Security, shall determine whether the individual is on
such list.
(b) Monitoring Benefits.--
(1) In general.--In the case of an enrolled WTC
responder (other than one described in subsection
(a)(2)(A)(ii)), the WTC Program shall provide for
monitoring benefits that include monitoring consistent
with protocols approved by the WTC Program
Administrator and including clinical examinations and
long-term health monitoring and analysis. In the case
of an enrolled WTC responder who is an active member of
the Fire Department of New York City, the responder
shall receive such benefits as part of the individual's
periodic company medical exams.
(2) Provision of monitoring benefits.--The
monitoring benefits under paragraph (1) shall be
provided through the Clinical Center of Excellence for
the type of individual involved or, in the case of an
individual residing outside the New York metropolitan
area, under an arrangement under section 3313.
SEC. 3312. TREATMENT OF ENROLLED WTC RESPONDERS FOR WTC-RELATED HEALTH
CONDITIONS.
(a) WTC-Related Health Condition Defined.--
(1) In general.--For purposes of this title, the
term ``WTC-related health condition'' means a condition
that--
(A)(i) is an illness or health condition
for which exposure to airborne toxins, any
other hazard, or any other adverse condition
resulting from the September 11, 2001,
terrorist attacks, based on an examination by a
medical professional with experience in
treating or diagnosing the health conditions
included in the applicable list of WTC-related
health conditions, is substantially likely to
be a significant factor in aggravating,
contributing to, or causing the illness or
health condition, as determined under paragraph
(2); or
(ii) is a mental health condition for which
such attacks, based on an examination by a
medical professional with experience in
treating or diagnosing the health conditions
included in the applicable list of WTC-related
health conditions, is substantially likely to
be a significant factor in aggravating,
contributing to, or causing the condition, as
determined under paragraph (2); and
(B) is included in the applicable list of
WTC-related health conditions or--
(i) with respect to a WTC
responder, is provided certification of
coverage under subsection
(b)(2)(B)(iii); or
(ii) with respect to a screening-
eligible WTC survivor or certified-
eligible WTC survivor, is provided
certification of coverage under
subsection (b)(2)(B)(iii), as applied
under section 3322(a).
In the case of a WTC responder described in section
3311(a)(2)(A)(ii) (relating to a surviving immediate
family member of a firefighter), such term does not
include an illness or health condition described in
subparagraph (A)(i).
(2) Determination.--The determination under
paragraph (1) or subsection (b) of whether the
September 11, 2001, terrorist attacks were
substantially likely to be a significant factor in
aggravating, contributing to, or causing an
individual's illness or health condition shall be made
based on an assessment of the following:
(A) The individual's exposure to airborne
toxins, any other hazard, or any other adverse
condition resulting from the terrorist attacks.
Such exposure shall be--
(i) evaluated and characterized
through the use of a standardized,
population-appropriate questionnaire
approved by the Director of the
National Institute for Occupational
Safety and Health; and
(ii) assessed and documented by a
medical professional with experience in
treating or diagnosing health
conditions included on the list of WTC-
related health conditions.
(B) The type of symptoms and temporal
sequence of symptoms. Such symptoms shall be--
(i) assessed through the use of a
standardized, population-appropriate
medical questionnaire approved by the
Director of the National Institute for
Occupational Safety and Health and a
medical examination; and
(ii) diagnosed and documented by a
medical professional described in
subparagraph (A)(ii).
(3) List of health conditions for wtc responders.--
The list of health conditions for WTC responders
consists of the following:
(A) Aerodigestive disorders.--
(i) Interstitial lung diseases.
(ii) Chronic respiratory disorder--
fumes/vapors.
(iii) Asthma.
(iv) Reactive airways dysfunction
syndrome (RADS).
(v) WTC-exacerbated chronic
obstructive pulmonary disease (COPD).
(vi) Chronic cough syndrome.
(vii) Upper airway hyperreactivity.
(viii) Chronic rhinosinusitis.
(ix) Chronic nasopharyngitis.
(x) Chronic laryngitis.
(xi) Gastroesophageal reflux
disorder (GERD).
(xii) Sleep apnea exacerbated by or
related to a condition described in a
previous clause.
(B) Mental health conditions.--
(i) Posttraumatic stress disorder
(PTSD).
(ii) Major depressive disorder.
(iii) Panic disorder.
(iv) Generalized anxiety disorder.
(v) Anxiety disorder (not otherwise
specified).
(vi) Depression (not otherwise
specified).
(vii) Acute stress disorder.
(viii) Dysthymic disorder.
(ix) Adjustment disorder.
(x) Substance abuse.
(C) Musculoskeletal disorders for certain
wtc responders.--In the case of a WTC responder
described in paragraph (4), a condition
described in such paragraph.
(D) Additional conditions.--Any cancer (or
type of cancer) or other condition added,
pursuant to paragraph (5) or (6), to the list
under this paragraph.
(4) Musculoskeletal disorders.--
(A) In general.--For purposes of this
title, in the case of a WTC responder who
received any treatment for a WTC-related
musculoskeletal disorder on or before September
11, 2003, the list of health conditions in
paragraph (3) shall include:
(i) Low back pain.
(ii) Carpal tunnel syndrome (CTS).
(iii) Other musculoskeletal
disorders.
(B) Definition.--The term ``WTC-related
musculoskeletal disorder'' means a chronic or
recurrent disorder of the musculoskeletal
system caused by heavy lifting or repetitive
strain on the joints or musculoskeletal system
occurring during rescue or recovery efforts in
the New York City disaster area in the
aftermath of the September 11, 2001, terrorist
attacks.
(5) Cancer.--
(A) In general.--The WTC Program
Administrator shall periodically conduct a
review of all available scientific and medical
evidence, including findings and
recommendations of Clinical Centers of
Excellence, published in peer-reviewed journals
to determine if, based on such evidence, cancer
or a certain type of cancer should be added to
the applicable list of WTC-related health
conditions. The WTC Program Administrator shall
conduct the first review under this
subparagraph not later than 180 days after the
date of the enactment of this title.
(B) Proposed regulations and rulemaking.--
Based on the periodic reviews under
subparagraph (A), if the WTC Program
Administrator determines that cancer or a
certain type of cancer should be added to such
list of WTC-related health conditions, the WTC
Program Administrator shall propose
regulations, through rulemaking, to add cancer
or the certain type of cancer to such list.
(C) Final regulations.--Based on all the
available evidence in the rulemaking record,
the WTC Program Administrator shall make a
final determination of whether cancer or a
certain type of cancer should be added to such
list of WTC-related health conditions. If such
a determination is made to make such an
addition, the WTC Program Administrator shall
by regulation add cancer or the certain type of
cancer to such list.
(D) Determinations not to add cancer or
certain types of cancer.--In the case that the
WTC Program Administrator determines under
subparagraph (B) or (C) that cancer or a
certain type of cancer should not be added to
such list of WTC-related health conditions, the
WTC Program Administrator shall publish an
explanation for such determination in the
Federal Register. Any such determination to not
make such an addition shall not preclude the
addition of cancer or the certain type of
cancer to such list at a later date.
(6) Addition of health conditions to list for wtc
responders.--
(A) In general.--Whenever the WTC Program
Administrator determines that a proposed rule
should be promulgated to add a health condition
to the list of health conditions in paragraph
(3), the Administrator may request a
recommendation of the Advisory Committee or may
publish such a proposed rule in the Federal
Register in accordance with subparagraph (D).
(B) Administrator's options after receipt
of petition.--In the case that the WTC Program
Administrator receives a written petition by an
interested party to add a health condition to
the list of health conditions in paragraph (3),
not later than 60 days after the date of
receipt of such petition the Administrator
shall--
(i) request a recommendation of the
Advisory Committee;
(ii) publish a proposed rule in the
Federal Register to add such health
condition, in accordance with
subparagraph (D);
(iii) publish in the Federal
Register the Administrator's
determination not to publish such a
proposed rule and the basis for such
determination; or
(iv) publish in the Federal
Register a determination that
insufficient evidence exists to take
action under clauses (i) through (iii).
(C) Action by advisory committee.--In the
case that the Administrator requests a
recommendation of the Advisory Committee under
this paragraph, with respect to adding a health
condition to the list in paragraph (3), the
Advisory Committee shall submit to the
Administrator such recommendation not later
than 60 days after the date of such request or
by such date (not to exceed 180 days after such
date of request) as specified by the
Administrator. Not later than 60 days after the
date of receipt of such recommendation, the
Administrator shall, in accordance with
subparagraph (D), publish in the Federal
Register a proposed rule with respect to such
recommendation or a determination not to
propose such a proposed rule and the basis for
such determination.
(D) Publication.--The WTC Program
Administrator shall, with respect to any
proposed rule under this paragraph--
(i) publish such proposed rule in
accordance with section 553 of title 5,
United States Code; and
(ii) provide interested parties a
period of 30 days after such
publication to submit written comments
on the proposed rule.
The WTC Program Administrator may extend the
period described in clause (ii) upon a finding
of good cause. In the case of such an
extension, the Administrator shall publish such
extension in the Federal Register.
(E) Interested party defined.--For purposes
of this paragraph, the term ``interested
party'' includes a representative of any
organization representing WTC responders, a
nationally recognized medical association, a
Clinical or Data Center, a State or political
subdivision, or any other interested person.
(b) Coverage of Treatment for WTC-Related Health
Conditions.--
(1) Determination for enrolled wtc responders based
on a wtc-related health condition.--
(A) In general.--If a physician at a
Clinical Center of Excellence that is providing
monitoring benefits under section 3311 for an
enrolled WTC responder makes a determination
that the responder has a WTC-related health
condition that is in the list in subsection
(a)(3) and that exposure to airborne toxins,
other hazards, or adverse conditions resulting
from the September 1, 2001, terrorist attacks
is substantially likely to be a significant
factor in aggravating, contributing to, or
causing the condition--
(i) the physician shall promptly
transmit such determination to the WTC
Program Administrator and provide the
Administrator with the medical facts
supporting such determination; and
(ii) on and after the date of such
transmittal and subject to subparagraph
(B), the WTC Program shall provide for
payment under subsection (c) for
medically necessary treatment for such
condition.
(B) Review; certification; appeals.--
(i) Review.--A Federal employee
designated by the WTC Program
Administrator shall review
determinations made under subparagraph
(A).
(ii) Certification.--The
Administrator shall provide a
certification of such condition based
upon reviews conducted under clause
(i). Such a certification shall be
provided unless the Administrator
determines that the responder's
condition is not a WTC-related health
condition in the list in subsection
(a)(3) or that exposure to airborne
toxins, other hazards, or adverse
conditions resulting from the September
1, 2001, terrorist attacks is not
substantially likely to be a
significant factor in aggravating,
contributing to, or causing the
condition.
(iii) Appeal process.--The
Administrator shall establish, by rule,
a process for the appeal of
determinations under clause (ii).
(2) Determination based on medically associated
wtc-related health conditions.--
(A) In general.--If a physician at a
Clinical Center of Excellence determines
pursuant to subsection (a) that the enrolled
WTC responder has a health condition described
in subsection (a)(1)(A) that is not in the list
in subsection (a)(3) but which is medically
associated with a WTC-related health
condition--
(i) the physician shall promptly
transmit such determination to the WTC
Program Administrator and provide the
Administrator with the facts supporting
such determination; and
(ii) the Administrator shall make a
determination under subparagraph (B)
with respect to such physician's
determination.
(B) Procedures for review, certification,
and appeal.--The WTC Program Administrator
shall, by rule, establish procedures for the
review and certification of physician
determinations under subparagraph (A). Such
rule shall provide for--
(i) the timely review of such a
determination by a physician panel with
appropriate expertise for the condition
and recommendations to the WTC Program
Administrator;
(ii) not later than 60 days after
the date of the transmittal under
subparagraph (A)(i), a determination by
the WTC Program Administrator on
whether or not the condition involved
is described in subsection (a)(1)(A)
and is medically associated with a WTC-
related health condition;
(iii) certification in accordance
with paragraph (1)(B)(ii) of coverage
of such condition if determined to be
described in subsection (a)(1)(A) and
medically associated with a WTC-related
health condition; and
(iv) a process for appeals of
determinations relating to such
conditions.
(C) Inclusion in list of health
conditions.--If the WTC Program Administrator
provides certification under subparagraph
(B)(iii) for coverage of a condition, the
Administrator may, pursuant to subsection
(a)(6), add the condition to the list in
subsection (a)(3).
(D) Conditions already declined for
inclusion in list.--If the WTC Program
Administrator publishes a determination under
subsection (a)(6)(B) not to include a condition
in the list in subsection (a)(3), the WTC
Program Administrator shall not provide
certification under subparagraph (B)(iii) for
coverage of the condition. In the case of an
individual who is certified under subparagraph
(B)(iii) with respect to such condition before
the date of the publication of such
determination the previous sentence shall not
apply.
(3) Requirement of medical necessity.--
(A) In general.--In providing treatment for
a WTC-related health condition, a physician or
other provider shall provide treatment that is
medically necessary and in accordance with
medical treatment protocols established under
subsection (d).
(B) Regulations relating to medical
necessity.--For the purpose of this title, the
WTC Program Administrator shall issue
regulations specifying a standard for
determining medical necessity with respect to
health care services and prescription
pharmaceuticals, a process for determining
whether treatment furnished and pharmaceuticals
prescribed under this title meet such standard
(including any prior authorization
requirement), and a process for appeal of a
determination under subsection (c)(3).
(4) Scope of treatment covered.--
(A) In general.--The scope of treatment
covered under this subsection includes services
of physicians and other health care providers,
diagnostic and laboratory tests, prescription
drugs, inpatient and outpatient hospital
services, and other medically necessary
treatment.
(B) Pharmaceutical coverage.--With respect
to ensuring coverage of medically necessary
outpatient prescription drugs, such drugs shall
be provided, under arrangements made by the WTC
Program Administrator, directly through
participating Clinical Centers of Excellence or
through one or more outside vendors.
(C) Transportation expenses for nationwide
network.--The WTC Program Administrator may
provide for necessary and reasonable
transportation and expenses incident to the
securing of medically necessary treatment
through the nationwide network under section
3313 involving travel of more than 250 miles
and for which payment is made under this
section in the same manner in which individuals
may be furnished necessary and reasonable
transportation and expenses incident to
services involving travel of more than 250
miles under regulations implementing section
3629(c) of the Energy Employees Occupational
Illness Compensation Program Act of 2000 (title
XXXVI of Public Law 106-398; 42 U.S.C.
7384t(c)).
(5) Provision of treatment pending certification.--
With respect to an enrolled WTC responder for whom a
determination is made by an examining physician under
paragraph (1) or (2), but for whom the WTC Program
Administrator has not yet determined whether to certify
the determination, the WTC Program Administrator may
establish by rule a process through which the
Administrator may approve the provision of medical
treatment under this subsection (and payment under
subsection (c)) with respect to such responder and such
responder's WTC-related health condition (under such
terms and conditions as the Administrator may provide)
until the Administrator makes a decision on whether to
certify the determination.
(c) Payment for Initial Health Evaluation, Monitoring, and
Treatment of WTC-Related Health Conditions.--
(1) Medical treatment.--
(A) Use of feca payment rates.--
(i) In general.--Subject to clause
(ii):
(I) Subject to
subparagraphs (B) and (C), the
WTC Program Administrator shall
reimburse costs for medically
necessary treatment under this
title for WTC-related health
conditions according to the
payment rates that would apply
to the provision of such
treatment and services by the
facility under the Federal
Employees Compensation Act.
(II) For treatment not
covered under subclause (i) or
subparagraph (B), the WTC
Program Administrator shall
establish by regulation a
reimbursement rate for such
treatment.
(ii) Exception.--In no case shall
payments for products or services under
clause (i) be made at a rate higher
than the Office of Worker's
Compensation Programs in the Department
Labor would pay for such products or
services rendered at the time such
products or services were provided.
(B) Pharmaceuticals.--
(i) In general.--The WTC Program
Administrator shall establish a program
for paying for the medically necessary
outpatient prescription pharmaceuticals
prescribed under this title for WTC-
related health conditions through one
or more contracts with outside vendors.
(ii) Competitive bidding.--Under
such program the Administrator shall--
(I) select one or more
appropriate vendors through a
Federal competitive bid
process; and
(II) select the lowest
bidder (or bidders) meeting the
requirements for providing
pharmaceutical benefits for
participants in the WTC
Program.
(iii) Treatment of fdny
participants.--Under such program the
Administrator may enter into an
agreement with a separate vendor to
provide pharmaceutical benefits to
enrolled WTC responders for whom the
Clinical Center of Excellence is
described in section 3305 if such an
arrangement is deemed necessary and
beneficial to the program by the WTC
Program Administrator.
(iv) Pharmaceuticals.--Not later
than July 1, 2011, the Comptroller
General of the United States shall
submit to the Committee on Energy and
Commerce of the House of
Representatives and the Committee on
Health, Education, Labor, and Pensions
of the Senate a report on whether
existing Federal pharmaceutical
purchasing programs can provide
pharmaceutical benefits more
efficiently and effectively than
through the WTC program.
(C) Improving quality and efficiency
through modification of payment amounts and
methodologies.--The WTC Program Administrator
may modify the amounts and methodologies for
making payments for initial health evaluations,
monitoring, or treatment, if, taking into
account utilization and quality data furnished
by the Clinical Centers of Excellence under
section 3305(b)(1)(B)(iii), the Administrator
determines that a bundling, capitation, pay for
performance, or other payment methodology would
better ensure high quality and efficient
delivery of initial health evaluations,
monitoring, or treatment to an enrolled WTC
responder, screening-eligible WTC survivor, or
certified-eligible WTC survivor.
(2) Monitoring and initial health evaluation.--The
WTC Program Administrator shall reimburse the costs of
monitoring and the costs of an initial health
evaluation provided under this title at a rate set by
the Administrator by regulation.
(3) Determination of medical necessity.--
(A) Review of medical necessity and
protocols.--As part of the process for
reimbursement or payment under this subsection,
the WTC Program Administrator shall provide for
the review of claims for reimbursement or
payment for the provision of medical treatment
to determine if such treatment is medically
necessary and in accordance with medical
treatment protocols established under
subsection (d).
(B) Withholding of payment for medically
unnecessary treatment.--The Administrator shall
withhold such reimbursement or payment for
treatment that the Administrator determines is
not medically necessary or is not in accordance
with such medical treatment protocols.
(d) Medical Treatment Protocols.--
(1) Development.--The Data Centers shall develop
medical treatment protocols for the treatment of
enrolled WTC responders and certified-eligible WTC
survivors for health conditions included in the
applicable list of WTC-related health conditions.
(2) Approval.--The medical treatment protocols
developed under paragraph (1) shall be subject to
approval by the WTC Program Administrator.
SEC. 3313. NATIONAL ARRANGEMENT FOR BENEFITS FOR ELIGIBLE INDIVIDUALS
OUTSIDE NEW YORK.
(a) In General.--In order to ensure reasonable access to
benefits under this subtitle for individuals who are enrolled
WTC responders, screening-eligible WTC survivors, or certified-
eligible WTC survivors and who reside in any State, as defined
in section 2(f), outside the New York metropolitan area, the
WTC Program Administrator shall establish a nationwide network
of health care providers to provide monitoring and treatment
benefits and initial health evaluations near such individuals'
areas of residence in such States. Nothing in this subsection
shall be construed as preventing such individuals from being
provided such monitoring and treatment benefits or initial
health evaluation through any Clinical Center of Excellence.
(b) Network Requirements.--Any health care provider
participating in the network under subsection (a) shall--
(1) meet criteria for credentialing established by
the Data Centers;
(2) follow the monitoring, initial health
evaluation, and treatment protocols developed under
section 3305(a)(2)(A)(ii);
(3) collect and report data in accordance with
section 3304; and
(4) meet such fraud, quality assurance, and other
requirements as the WTC Program Administrator
establishes, including sections 1128 through 1128E of
the Social Security Act, as applied by section 3301(d).
(c) Training and Technical Assistance.--The WTC Program
Administer may provide, including through contract, for the
provision of training and technical assistance to health care
providers participating in the network under subsection (a).
(d) Provision of Services Through the VA.--
(1) In general.--The WTC Program Administrator may
enter into an agreement with the Secretary of Veterans
Affairs for the Secretary to provide services under
this section through facilities of the Department of
Veterans Affairs.
(2) National program.--Not later than July 1, 2011,
the Comptroller General of the United States shall
submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
on whether the Department of Veterans Affairs can
provide monitoring and treatment services to
individuals under this section more efficiently and
effectively than through the nationwide network to be
established under subsection (a).
PART 2--WTC SURVIVORS
SEC. 3321. IDENTIFICATION AND INITIAL HEALTH EVALUATION OF SCREENING-
ELIGIBLE AND CERTIFIED-ELIGIBLE WTC SURVIVORS.
(a) Identification of Screening-Eligible WTC Survivors and
Certified-Eligible WTC Survivors.--
(1) Screening-eligible wtc survivors.--
(A) Definition.--In this title, the term
``screening-eligible WTC survivor'' means,
subject to subparagraph (C) and paragraph (3),
an individual who is described in any of the
following clauses:
(i) Currently identified
survivor.--An individual, including a
WTC responder, who has been identified
as eligible for medical treatment and
monitoring by the WTC Environmental
Health Center as of the date of
enactment of this title.
(ii) Survivor who meets current
eligibility criteria.--An individual
who is not a WTC responder, for
purposes of the initial health
evaluation under subsection (b), claims
symptoms of a WTC-related health
condition and meets any of the current
eligibility criteria described in
subparagraph (B).
(iii) Survivor who meets modified
eligibility criteria.--An individual
who is not a WTC responder, for
purposes of the initial health
evaluation under subsection (b), claims
symptoms of a WTC-related health
condition and meets such eligibility
criteria relating to exposure to
airborne toxins, other hazards, or
adverse conditions resulting from the
September 11, 2001, terrorist attacks
as the WTC Administrator determines,
after consultation with the Data
Centers described in section 3305 and
the WTC Scientific/Technical Advisory
Committee and WTC Health Program
Steering Committees under section 3302.
The Administrator shall not modify such
criteria under clause (iii) on or after the
date that the number of certifications for
certified-eligible WTC survivors under
paragraph (2)(B) has reached 80 percent of the
limit described in paragraph (3) or on or after
the date that the number of enrollments of WTC
responders has reached 80 percent of the limit
described in section 3311(a)(4).
(B) Current eligibility criteria.--The
eligibility criteria described in this
subparagraph for an individual are that the
individual is described in any of the following
clauses:
(i) A person who was present in the
New York City disaster area in the dust
or dust cloud on September 11, 2001.
(ii) A person who worked, resided,
or attended school, childcare, or adult
daycare in the New York City disaster
area for--
(I) at least 4 days during
the 4-month period beginning on
September 11, 2001, and ending
on January 10, 2002; or
(II) at least 30 days
during the period beginning on
September 11, 2001, and ending
on July 31, 2002.
(iii) Any person who worked as a
cleanup worker or performed maintenance
work in the New York City disaster area
during the 4-month period described in
subparagraph (B)(i) and had extensive
exposure to WTC dust as a result of
such work.
(iv) A person who was deemed
eligible to receive a grant from the
Lower Manhattan Development Corporation
Residential Grant Program, who
possessed a lease for a residence or
purchased a residence in the New York
City disaster area, and who resided in
such residence during the period
beginning on September 11, 2001, and
ending on May 31, 2003.
(v) A person whose place of
employment--
(I) at any time during the
period beginning on September
11, 2001, and ending on May 31,
2003, was in the New York City
disaster area; and
(II) was deemed eligible to
receive a grant from the Lower
Manhattan Development
Corporation WTC Small Firms
Attraction and Retention Act
program or other government
incentive program designed to
revitalize the lower Manhattan
economy after the September 11,
2001, terrorist attacks.
(C) Application and determination process
for screening eligibility.--
(i) In general.--The WTC Program
Administrator in consultation with the
Data Centers shall establish a process
for individuals, other than individuals
described in subparagraph (A)(i), to be
determined to be screening-eligible WTC
survivors. Under such process--
(I) there shall be no fee
charged to the applicant for
making an application for such
determination;
(II) the Administrator
shall make a determination on
such an application not later
than 60 days after the date of
filing the application;
(III) the Administrator
shall make such a determination
relating to an applicant's
compliance with this title and
shall not determine that an
individual is not so eligible
or deny written documentation
under clause (ii) to such
individual unless the
Administrator determines that--
(aa) based on the
application submitted,
the individual does not
meet the eligibility
criteria; or
(bb) the numerical
limitation on
certifications of
certified-eligible WTC
survivors set forth in
paragraph (3) has been
met; and
(IV) an individual who is
determined not to be a
screening-eligible WTC survivor
shall have an opportunity to
appeal such determination in a
manner established under such
process.
(ii) Written documentation of
screening-eligibility.--
(I) In general.--In the
case of an individual who is
described in subparagraph
(A)(i) or who is determined
under clause (i) (consistent
with paragraph (3)) to be a
screening-eligible WTC
survivor, the WTC Program
Administrator shall provide an
appropriate written
documentation of such fact.
(II) Timing.--
(aa) Currently
identified survivors.--
In the case of an
individual who is
described in
subparagraph (A)(i),
the WTC Program
Administrator shall
provide the written
documentation under
subclause (I) not later
than July 1, 2011.
(bb) Other
members.--In the case
of another individual
who is determined under
clause (i) and
consistent with
paragraph (3) to be a
screening-eligible WTC
survivor, the WTC
Program Administrator
shall provide the
written documentation
under subclause (I) at
the time of such
determination.
(2) Certified-eligible wtc survivors.--
(A) Definition.--The term ``certified-
eligible WTC survivor'' means, subject to
paragraph (3), a screening-eligible WTC
survivor who the WTC Program Administrator
certifies under subparagraph (B) to be eligible
for followup monitoring and treatment under
this part.
(B) Certification of eligibility for
monitoring and treatment.--
(i) In general.--The WTC Program
Administrator shall establish a
certification process under which the
Administrator shall provide appropriate
certification to screening-eligible WTC
survivors who, pursuant to the initial
health evaluation under subsection (b),
are determined to be eligible for
followup monitoring and treatment under
this part.
(ii) Timing.--
(I) Currently identified
survivors.--In the case of an
individual who is described in
paragraph (1)(A)(i), the WTC
Program Administrator shall
provide the certification under
clause (i) not later than July
1, 2011.
(II) Other members.--In the
case of another individual who
is determined under clause (i)
to be eligible for followup
monitoring and treatment, the
WTC Program Administrator shall
provide the certification under
such clause at the time of such
determination.
(3) Numerical limitation on certified-eligible wtc
survivors.--
(A) In general.--The total number of
individuals not described in paragraph
(1)(A)(i) who may be certified as certified-
eligible WTC survivors under paragraph (2)(B)
shall not exceed 25,000 at any time.
(B) Process.--In implementing subparagraph
(A), the WTC Program Administrator shall--
(i) limit the number of
certifications provided under paragraph
(2)(B)--
(I) in accordance with such
subparagraph; and
(II) to such number, as
determined by the Administrator
based on the best available
information and subject to
amounts made available under
section 3351, that will ensure
sufficient funds will be
available to provide treatment
and monitoring benefits under
this title, with respect to all
individuals receiving such
certifications through the end
of fiscal year 2020; and
(ii) provide priority in such
certifications in the order in which
individuals apply for a determination
under paragraph (2)(B).
(4) Disqualification of individuals on terrorist
watch list.--No individual who is on the terrorist
watch list maintained by the Department of Homeland
Security shall qualify as a screening-eligible WTC
survivor or a certified-eligible WTC survivor. Before
determining any individual to be a screening-eligible
WTC survivor under paragraph (1) or certifying any
individual as a certified eligible WTC survivor under
paragraph (2), the Administrator, in consultation with
the Secretary of Homeland Security, shall determine
whether the individual is on such list.
(b) Initial Health Evaluation To Determine Eligibility for
Followup Monitoring or Treatment.--
(1) In general.--In the case of a screening-
eligible WTC survivor, the WTC Program shall provide
for an initial health evaluation to determine if the
survivor has a WTC-related health condition and is
eligible for followup monitoring and treatment benefits
under the WTC Program. Initial health evaluation
protocols under section 3305(a)(2)(A)(ii) shall be
subject to approval by the WTC Program Administrator.
(2) Initial health evaluation providers.--The
initial health evaluation described in paragraph (1)
shall be provided through a Clinical Center of
Excellence with respect to the individual involved.
(3) Limitation on initial health evaluation
benefits.--Benefits for an initial health evaluation
under this part for a screening-eligible WTC survivor
shall consist only of a single medical initial health
evaluation consistent with initial health evaluation
protocols described in paragraph (1). Nothing in this
paragraph shall be construed as preventing such an
individual from seeking additional medical initial
health evaluations at the expense of the individual.
SEC. 3322. FOLLOWUP MONITORING AND TREATMENT OF CERTIFIED-ELIGIBLE WTC
SURVIVORS FOR WTC-RELATED HEALTH CONDITIONS.
(a) In General.--Subject to subsection (b), the provisions
of sections 3311 and 3312 shall apply to followup monitoring
and treatment of WTC-related health conditions for certified-
eligible WTC survivors in the same manner as such provisions
apply to the monitoring and treatment of WTC-related health
conditions for enrolled WTC responders.
(b) List of WTC-Related Health Conditions for Survivors.--
The list of health conditions for screening-eligible WTC
survivors and certified-eligible WTC survivors consists of the
following:
(1) Aerodigestive disorders.--
(A) Interstitial lung diseases.
(B) Chronic respiratory disorder--fumes/
vapors.
(C) Asthma.
(D) Reactive airways dysfunction syndrome
(RADS).
(E) WTC-exacerbated chronic obstructive
pulmonary disease (COPD).
(F) Chronic cough syndrome.
(G) Upper airway hyperreactivity.
(H) Chronic rhinosinusitis.
(I) Chronic nasopharyngitis.
(J) Chronic laryngitis.
(K) Gastroesophageal reflux disorder
(GERD).
(L) Sleep apnea exacerbated by or related
to a condition described in a previous clause.
(2) Mental health conditions.--
(A) Posttraumatic stress disorder (PTSD).
(B) Major depressive disorder.
(C) Panic disorder.
(D) Generalized anxiety disorder.
(E) Anxiety disorder (not otherwise
specified).
(F) Depression (not otherwise specified).
(G) Acute stress disorder.
(H) Dysthymic disorder.
(I) Adjustment disorder.
(J) Substance abuse.
(3) Additional conditions.--Any cancer (or type of
cancer) or other condition added to the list in section
3312(a)(3) pursuant to paragraph (5) or (6) of section
3312(a), as such provisions are applied under
subsection (a) with respect to certified-eligible WTC
survivors.
SEC. 3323. FOLLOWUP MONITORING AND TREATMENT OF OTHER INDIVIDUALS WITH
WTC-RELATED HEALTH CONDITIONS.
(a) In General.--Subject to subsection (c), the provisions
of section 3322 shall apply to the followup monitoring and
treatment of WTC-related health conditions in the case of
individuals described in subsection (b) in the same manner as
such provisions apply to the followup monitoring and treatment
of WTC-related health conditions for certified-eligible WTC
survivors.
(b) Individuals Described.--An individual described in this
subsection is an individual who, regardless of location of
residence--
(1) is not an enrolled WTC responder or a
certified-eligible WTC survivor; and
(2) is diagnosed at a Clinical Center of Excellence
with a WTC-related health condition for certified-
eligible WTC survivors.
(c) Limitation.--
(1) In general.--The WTC Program Administrator
shall limit benefits for any fiscal year under
subsection (a) in a manner so that payments under this
section for such fiscal year do not exceed the amount
specified in paragraph (2) for such fiscal year.
(2) Limitation.--The amount specified in this
paragraph for--
(A) the last calendar quarter of fiscal
year 2011 is $5,000,000;
(B) fiscal year 2012 is $20,000,000; or
(C) a succeeding fiscal year is the amount
specified in this paragraph for the previous
fiscal year increased by the annual percentage
increase in the medical care component of the
consumer price index for all urban consumers.
PART 3--PAYOR PROVISIONS
SEC. 3331. PAYMENT OF CLAIMS.
(a) In General.--Except as provided in subsections (b) and
(c), the cost of monitoring and treatment benefits and initial
health evaluation benefits provided under parts 1 and 2 of this
subtitle shall be paid for by the WTC Program from the World
Trade Center Health Program Fund.
(b) Workers' Compensation Payment.--
(1) In general.--Subject to paragraph (2), payment
for treatment under parts 1 and 2 of this subtitle of a
WTC-related health condition of an individual that is
work-related shall be reduced or recouped to the extent
that the WTC Program Administrator determines that
payment has been made, or can reasonably be expected to
be made, under a workers' compensation law or plan of
the United States, a State, or a locality, or other
work-related injury or illness benefit plan of the
employer of such individual, for such treatment. The
provisions of clauses (iii), (iv), (v), and (vi) of
paragraph (2)(B) of section 1862(b) of the Social
Security Act and paragraphs (3) and (4) of such section
shall apply to the recoupment under this subsection of
a payment to the WTC Program (with respect to a
workers' compensation law or plan, or other work-
related injury or illness plan of the employer
involved, and such individual) in the same manner as
such provisions apply to the reimbursement of a payment
under section 1862(b)(2) of such Act to the Secretary
(with respect to such a law or plan and an individual
entitled to benefits under title XVIII of such Act)
except that any reference in such paragraph (4) to
payment rates under title XVIII of the Social Security
Act shall be deemed a reference to payment rates under
this title.
(2) Exception.--Paragraph (1) shall not apply for
any quarter, with respect to any workers' compensation
law or plan, including line of duty compensation, to
which New York City is obligated to make payments, if,
in accordance with terms specified under the contract
under subsection (d)(1)(A), New York City has made the
full payment required under such contract for such
quarter.
(3) Rules of construction.--Nothing in this title
shall be construed to affect, modify, or relieve any
obligations under a worker's compensation law or plan,
other work-related injury or illness benefit plan of an
employer, or any health insurance plan.
(c) Health Insurance Coverage.--
(1) In general.--In the case of an individual who
has a WTC-related health condition that is not work-
related and has health coverage for such condition
through any public or private health plan (including
health benefits under title XVIII, XIX, or XXI of the
Social Security Act) the provisions of section 1862(b)
of the Social Security Act shall apply to such a health
plan and such individual in the same manner as they
apply to group health plan and an individual entitled
to benefits under title XVIII of such Act pursuant to
section 226(a) of such Act. Any costs for items and
services covered under such plan that are not
reimbursed by such health plan, due to the application
of deductibles, copayments, coinsurance, other cost
sharing, or otherwise, are reimbursable under this
title to the extent that they are covered under the WTC
Program. The program under this title shall not be
treated as a legally liable party for purposes of
applying section 1902(a)(25) of the Social Security
Act.
(2) Recovery by individual providers.--Nothing in
paragraph (1) shall be construed as requiring an entity
providing monitoring and treatment under this title to
seek reimbursement under a health plan with which the
entity has no contract for reimbursement.
(3) Maintenance of required minimum essential
coverage.--No payment may be made for monitoring and
treatment under this title for an individual for a
month (beginning with July 2014) if with respect to
such month the individual--
(A) is an applicable individual (as defined
in subsection (d) of section 5000A of Internal
Revenue Code of 1986) for whom the exemption
under subsection (e) of such section does not
apply; and
(B) is not covered under minimum essential
coverage, as required under subsection (a) of
such section.
(d) Required Contribution by New York City in Program
Costs.--
(1) Contract requirement.--
(A) In general.--No funds may be disbursed
from the World Trade Center Health Program Fund
under section 3351 unless New York City has
entered into a contract with the WTC Program
Administrator under which New York City agrees,
in a form and manner specified by the
Administrator, to pay the full contribution
described in subparagraph (B) in accordance
with this subsection on a timely basis, plus
any interest owed pursuant to subparagraph
(E)(i). Such contract shall specify the terms
under which New York City shall be considered
to have made the full payment required for a
quarter for purposes of subsection (b)(2).
(B) Full contribution amount.--Under such
contract, with respect to the last calendar
quarter of fiscal year 2011 and each calendar
quarter in fiscal years 2012 through 2015 the
full contribution amount under this
subparagraph shall be equal to 10 percent of
the expenditures in carrying out this title for
the respective quarter and with respect to
calendar quarters in fiscal year 2016, such
full contribution amount shall be equal to \1/
9\ of the Federal expenditures in carrying out
this title for the respective quarter.
(C) Satisfaction of payment obligation.--
The payment obligation under such contract may
not be satisfied through any of the following:
(i) An amount derived from Federal
sources.
(ii) An amount paid before the date
of the enactment of this title.
(iii) An amount paid to satisfy a
judgment or as part of a settlement
related to injuries or illnesses
arising out of the September 11, 2001,
terrorist attacks.
(D) Timing of contribution.--The payment
obligation under such contract for a calendar
quarter in a fiscal year shall be paid not
later than the last day of the second
succeeding calendar quarter.
(E) Compliance.--
(i) Interest for late payment.--If
New York City fails to pay to the WTC
Program Administrator pursuant to such
contract the amount required for any
calendar quarter by the day specified
in subparagraph (D), interest shall
accrue on the amount not so paid at the
rate (determined by the Administrator)
based on the average yield to maturity,
plus 1 percentage point, on outstanding
municipal bonds issued by New York City
with a remaining maturity of at least 1
year.
(ii) Recovery of amounts owed.--The
amounts owed to the WTC Program
Administrator under such contract shall
be recoverable by the United States in
an action in the same manner as
payments made under title XVIII of the
Social Security Act may be recoverable
in an action brought under section
1862(b)(2)(B)(iii) of such Act.
(F) Deposit in fund.--The WTC Program
Administer shall deposit amounts paid under
such contract into the World Trade Center
Health Program Fund under section 3351.
(2) Payment of new york city share of monitoring
and treatment costs.--With respect to each calendar
quarter for which a contribution is required by New
York City under the contract under paragraph (1), the
WTC Program Administrator shall--
(A) provide New York City with an estimate
of such amount of the required contribution at
the beginning of such quarter and with an
updated estimate of such amount at the
beginning of each of the subsequent 2 quarters;
(B) bill such amount directly to New York
City; and
(C) certify periodically, for purposes of
this subsection, whether or not New York City
has paid the amount so billed.
Such amount shall initially be estimated by the WTC
Program Administrator and shall be subject to
adjustment and reconciliation based upon actual
expenditures in carrying out this title.
(3) Rule of construction.--Nothing in this
subsection shall be construed as authorizing the WTC
Administrator, with respect to a fiscal year, to reduce
the numerical limitation under section 3311(a)(4) or
3321(a)(3) for such fiscal year if New York City fails
to comply with paragraph (1) for a calendar quarter in
such fiscal year.
(e) Work-Related Described.--For the purposes of this
section, a WTC-related health condition shall be treated as a
condition that is work-related if--
(1) the condition is diagnosed in an enrolled WTC
responder, or in an individual who qualifies as a
certified-eligible WTC survivor on the basis of being a
rescue, recovery, or cleanup worker; or
(2) with respect to the condition the individual
has filed and had established a claim under a workers'
compensation law or plan of the United States or a
State, or other work-related injury or illness benefit
plan of the employer of such individual.
SEC. 3332. ADMINISTRATIVE ARRANGEMENT AUTHORITY.
The WTC Program Administrator may enter into arrangements
with other government agencies, insurance companies, or other
third-party administrators to provide for timely and accurate
processing of claims under sections 3312, 3313, 3322, and 3323.
Subtitle C--Research Into Conditions
SEC. 3341. RESEARCH REGARDING CERTAIN HEALTH CONDITIONS RELATED TO
SEPTEMBER 11 TERRORIST ATTACKS.
(a) In General.--With respect to individuals, including
enrolled WTC responders and certified-eligible WTC survivors,
receiving monitoring or treatment under subtitle B, the WTC
Program Administrator shall conduct or support--
(1) research on physical and mental health
conditions that may be related to the September 11,
2001, terrorist attacks;
(2) research on diagnosing WTC-related health
conditions of such individuals, in the case of
conditions for which there has been diagnostic
uncertainty; and
(3) research on treating WTC-related health
conditions of such individuals, in the case of
conditions for which there has been treatment
uncertainty.
The Administrator may provide such support through continuation
and expansion of research that was initiated before the date of
the enactment of this title and through the World Trade Center
Health Registry (referred to in section 3342), through a
Clinical Center of Excellence, or through a Data Center.
(b) Types of Research.--The research under subsection
(a)(1) shall include epidemiologic and other research studies
on WTC-related health conditions or emerging conditions--
(1) among enrolled WTC responders and certified-
eligible WTC survivors under treatment; and
(2) in sampled populations outside the New York
City disaster area in Manhattan as far north as 14th
Street and in Brooklyn, along with control populations,
to identify potential for long-term adverse health
effects in less exposed populations.
(c) Consultation.--The WTC Program Administrator shall
carry out this section in consultation with the WTC Scientific/
Technical Advisory Committee.
(d) Application of Privacy and Human Subject Protections.--
The privacy and human subject protections applicable to
research conducted under this section shall not be less than
such protections applicable to research conducted or funded by
the Department of Health and Human Services.
SEC. 3342. WORLD TRADE CENTER HEALTH REGISTRY.
For the purpose of ensuring ongoing data collection
relating to victims of the September 11, 2001, terrorist
attacks, the WTC Program Administrator shall ensure that a
registry of such victims is maintained that is at least as
comprehensive as the World Trade Center Health Registry
maintained under the arrangements in effect as of April 20,
2009, with the New York City Department of Health and Mental
Hygiene.
Subtitle D--Funding
SEC. 3351. WORLD TRADE CENTER HEALTH PROGRAM FUND.
(a) Establishment of Fund.--
(1) In general.--There is established a fund to be
known as the World Trade Center Health Program Fund
(referred to in this section as the ``Fund'').
(2) Funding.--Out of any money in the Treasury not
otherwise appropriated, there shall be deposited into
the Fund for each of fiscal years 2012 through 2016
(and the last calendar quarter of fiscal year 2011)--
(A) the Federal share, consisting of an
amount equal to the lesser of--
(i) 90 percent of the expenditures
in carrying out this title for the
respective fiscal year (initially based
on estimates, subject to subsequent
reconciliation based on actual
expenditures); or
(ii)(I) $71,000,000 for the last
calendar quarter of fiscal year 2011,
$318,000,000 for fiscal year 2012,
$354,000,000 for fiscal year 2013,
$382,000,000 for fiscal year 2014, and
$431,000,000 for fiscal year 2015; and
(II) subject to paragraph (4), an
additional amount for fiscal year 2016
from unexpended amounts for previous
fiscal years; plus
(B) the New York City share, consisting of
the amount contributed under the contract under
section 3331(d).
(3) Contract requirement.--
(A) In general.--No funds may be disbursed
from the Fund unless New York City has entered
into a contract with the WTC Program
Administrator under section 3331(d)(1).
(B) Breach of contract.--In the case of a
failure to pay the amount so required under the
contract--
(i) the amount is recoverable under
subparagraph (E)(ii) of such section;
(ii) such failure shall not affect
the disbursement of amounts from the
Fund; and
(iii) the Federal share described
in paragraph (2)(A) shall not be
increased by the amount so unpaid.
(4) Aggregate limitation on funding beginning with
fiscal year 2016.--Beginning with fiscal year 2016, in
no case shall the share of Federal funds deposited into
the Fund under paragraph (2) for such fiscal year and
previous fiscal years and quarters exceed the sum of
the amounts specified in paragraph (2)(A)(ii)(I).
(b) Mandatory Funds for Monitoring, Initial Health
Evaluations, Treatment, and Claims Processing.--
(1) In general.--The amounts deposited into the
Fund under subsection (a)(2) shall be available,
without further appropriation, consistent with
paragraph (2) and subsection (c), to carry out subtitle
B and sections 3302(a), 3303, 3304, 3305(a)(2),
3305(c), 3341, and 3342.
(2) Limitation on mandatory funding.--This title
does not establish any Federal obligation for payment
of amounts in excess of the amounts available from the
Fund for such purpose.
(3) Limitation on authorization for further
appropriations.--This title does not establish any
authorization for appropriation of amounts in excess of
the amounts available from the Fund under paragraph
(1).
(c) Limits on Spending for Certain Purposes.--Of the
amounts made available under subsection (b)(1), not more than
each of the following amounts may be available for each of the
following purposes:
(1) Surviving immediate family members of
firefighters.--For the purposes of carrying out
subtitle B with respect to WTC responders described in
section 3311(a)(2)(A)(ii)--
(A) for the last calendar quarter of fiscal
year 2011, $100,000;
(B) for fiscal year 2012, $400,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
(2) WTC health program scientific/technical
advisory committee.--For the purpose of carrying out
section 3302(a)--
(A) for the last calendar quarter of fiscal
year 2011, $25,000;
(B) for fiscal year 2012, $100,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
(3) Education and outreach.--For the purpose of
carrying out section 3303--
(A) for the last calendar quarter of fiscal
year 2011, $500,000;
(B) for fiscal year 2012, $2,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
(4) Uniform data collection.--For the purpose of
carrying out section 3304 and for reimbursing Data
Centers (as defined in section 3305(b)(2)) for the
costs incurred by such Centers in carrying out
activities under contracts entered into under section
3305(a)(2)--
(A) for the last calendar quarter of fiscal
year 2011, $2,500,000;
(B) for fiscal year 2012, $10,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
(5) Research regarding certain health conditions.--
For the purpose of carrying out section 3341--
(A) for the last calendar quarter of fiscal
year 2011, $3,750,000;
(B) for fiscal year 2012, $15,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
(6) World trade center health registry.--For the
purpose of carrying out section 3342--
(A) for the last calendar quarter of fiscal
year 2011, $1,750,000;
(B) for fiscal year 2012, $7,000,000; and
(C) for each subsequent fiscal year, the
amount specified under this paragraph for the
previous fiscal year increased by the
percentage increase in the consumer price index
for all urban consumers (all items; United
States city average) as estimated by the
Secretary for the 12-month period ending with
March of the previous year.
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