[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2014 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 42
Public Health
________________________
Parts 1 to 399
Revised as of October 1, 2014
Containing a codification of documents of general
applicability and future effect
As of October 1, 2014
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register.
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 42:
Chapter I--Public Health Service, Department of
Health and Human Services 3
Chapters II-III [Reserved]
Finding Aids:
Table of CFR Titles and Chapters........................ 951
Alphabetical List of Agencies Appearing in the CFR...... 971
List of CFR Sections Affected........................... 981
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 42 CFR 2.1 refers to
title 42, part 2, section
1.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, October 1, 2014), consult the ``List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
the revision date stated on the cover of each volume are not carried.
Code users may find the text of provisions in effect on any given date
in the past by using the appropriate List of CFR Sections Affected
(LSA). For the convenience of the reader, a ``List of CFR Sections
Affected'' is published at the end of each CFR volume. For changes to
the Code prior to the LSA listings at the end of the volume, consult
previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
Federal Regulations. An agency may add regulatory information at a
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used
editorially to indicate that a portion of the CFR was left vacant and
not accidentally dropped due to a printing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed as
an approved incorporation by reference, please contact the agency that
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CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Authorities
and Rules. A list of CFR titles, chapters, subchapters, and parts and an
alphabetical list of agencies publishing in the CFR are also included in
this volume.
[[Page vii]]
An index to the text of ``Title 3--The President'' is carried within
that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
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For inquiries concerning CFR reference assistance, call 202-741-6000
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The e-CFR is a regularly updated, unofficial editorial compilation
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of the Federal Register and the Government Printing Office. It is
available at www.ecfr.gov.
Charles A. Barth,
Director,
Office of the Federal Register.
October 1, 2014.
[[Page ix]]
THIS TITLE
Title 42--Public Health is composed of five volumes. The parts in
these volumes are arranged in the following order: Parts 1-399, parts
400-413, parts 414-429, parts 430 to 481, and part 482 to end. The first
volume (parts 1-399) contains current regulations issued under chapter
I--Public Health Service (HHS). The second, third, and fourth volumes
(parts 400-413, parts 414-429, and parts 430 to 481) include regulations
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS)
and the fifth volume (part 482 to end) contains the remaining
regulations in chapter IV and the regulations issued under chapter V by
the Office of Inspector General-Health Care (HHS). The contents of these
volumes represent all current regulations codified under this title of
the CFR as of October 1, 2014.
For this volume, Michele Bugenhagen was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Jim Hemphill.
[[Page 1]]
TITLE 42--PUBLIC HEALTH
(This book contains parts 1 to 399)
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Part
chapter i--Public Health Service, Department of Health and
Human Services............................................ 2
chapters ii-iii [Reserved]
[[Page 3]]
CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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Editorial Note: Nomenclature changes to chapter I appear at 67 FR
36549, May 24, 2002.
SUBCHAPTER A--GENERAL PROVISIONS
Part Page
1 [Reserved]
2 Confidentiality of alcohol and drug abuse
patient records......................... 7
2a Protection of identity--research subjects... 26
3 Patient safety organizations and patient
safety work product..................... 31
4 National Library of Medicine................ 63
5 Designation of health professional(s)
shortage areas.......................... 65
5a Rural physician training grant program...... 83
6 Federal tort claims act coverage of certain
grantees and individuals................ 83
7 Distribution of reference biological
standards and biological preparations... 86
8 Certification of opioid treatment programs.. 87
9 Standards of care for chimpanzees held in
the federally supported sanctuary system 107
10 340B Drug Pricing Program................... 120
SUBCHAPTER B--PERSONNEL
21 Commissioned officers....................... 124
22 Personnel other than commissioned officers.. 134
23 National Health Service Corps............... 135
24 Senior Biomedical Research Service.......... 144
SUBCHAPTER C--MEDICAL CARE AND EXAMINATIONS
31 Medical care for certain personnel of the
Coast Guard, National Ocean Survey,
Public Health Service, and former
Lighthouse Service...................... 148
[[Page 4]]
32 Medical care for persons with Hansen's
disease and other persons in emergencies 153
34 Medical examination of aliens............... 154
35 Hospital and station management............. 161
37 Specifications for medical examinations of
coal miners............................. 170
38 Disaster assistance for crisis counseling
and training............................ 196
SUBCHAPTER D--GRANTS
50 Policies of general applicability........... 200
51 Requirements applicable to the protection
and advocacy for individuals with mental
illness program......................... 219
51a Project grants for maternal and child health 231
51b Project grants for preventive health
services................................ 234
51c Grants for community health services........ 241
51d Mental health and substance abuse emergency
response procedures..................... 256
51e-51g [Reserved]
52 Grants for research projects................ 261
52a National Institutes of Health center grants. 265
52b National Institutes of Health construction
grants.................................. 270
52c Minority Biomedical Research Support Program 279
52d National Cancer Institute Clinical Cancer
Education Program....................... 281
52e National Heart, Lung, and Blood Institute
grants for prevention and control
projects................................ 284
52h Scientific peer review of research grant
applications and research and
development contract projects........... 287
53 Grants, loans and loan guarantees for
construction and modernization of
hospitals and medical facilities........ 293
54 Charitable Choice regulations applicable to
States receiving Substance Abuse
Prevention and Treatment block grants
and/or Projects for Assistance in
Transition from Homelessness grants..... 301
54a Charitable Choice regulations applicable to
States, local governments and religious
organizations receiving discretionary
funding under Title V of the Public
Health Service Act, 42 U.S.C. 290aa, et
seq., for substance abuse prevention and
treatment services...................... 304
55a Program grants for Black Lung clinics....... 309
56 Grants for migrant health services.......... 311
[[Page 5]]
57 Grants for construction of teaching
facilities, educational improvements,
scholarships and student loans.......... 331
58 Grants for training of public health and
allied health personnel................. 373
59 Grants for family planning services......... 373
59a National Library of Medicine grants......... 382
60 Health Education Assistance Loan Program.... 386
SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61 Fellowships................................. 418
62 National Health Service Corps Scholarship
and Loan Repayment Programs............. 423
63 Traineeships................................ 441
63a National Institutes of Health training
grants.................................. 444
64 National Library of Medicine training grants 448
64a Obligated service for mental health
traineeships............................ 450
65 National Institute of Environmental Health
Sciences hazardous waste worker training 454
65a National Institute of Environmental Health
Sciences hazardous substances basic
research and training grants............ 457
66 National Research Service Awards............ 461
67 Agency for Health Care Policy and Research
grants and contracts.................... 468
68 National Institutes of Health (NIH) Loan
Repayment Programs (LRPs)............... 478
SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70 Interstate quarantine....................... 487
71 Foreign quarantine.......................... 489
72 [Reserved]
73 Select agents and toxins.................... 515
75 Standards for the accreditation of
educational programs for and the
credentialing of radiologic personnel... 534
SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED
ACTIVITIES
80 Administrative functions, practices, and
procedures.............................. 548
81 Guidelines for determining probability of
causation under the energy employees
occupational illness compensation
program act of 2000..................... 549
82 Methods for conducting dose reconstruction
under the Energy Employees Occupational
Illness Compensation Program Act of 2000 556
[[Page 6]]
83 Procedures for designating classes of
employees as members of the special
exposure cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000........ 567
84 Approval of respiratory protective devices.. 579
85 Requests for health hazard evaluations...... 651
85a Occupational safety and health
investigations of places of employment.. 656
86 Grants for education programs in
occupational safety and health.......... 661
87 National Institute for Occupational Safety
and Health Research and demonstration
grants.................................. 669
88 World Trade Center Health Program........... 671
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS
SUBSTANCES RELEASES AND FACILITIES
90 Administrative functions, practices, and
procedures.............................. 684
93 Public health service policies on research
misconduct.............................. 688
SUBCHAPTER I [RESERVED]
SUBCHAPTER J--VACCINES
100 Vaccine injury compensation................. 717
102 Smallpox compensation program............... 722
110 Countermeasures injury compensation program. 749
SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121 Organ Procurement and Transplantation
Network................................. 774
124 Medical facility construction and
modernization........................... 785
125-129 [Reserved]
SUBCHAPTER L--COMPASSIONATE PAYMENTS
130 Ricky Ray Hemophilia Relief Fund Program.... 821
131-135 [Reserved]
SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
136 Indian health............................... 854
136a Indian health............................... 888
137 Tribal self-governance...................... 896
138-199 [Reserved]
[[Page 7]]
SUBCHAPTER A_GENERAL PROVISIONS
PART 1 [RESERVED]
PART 2_CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS
--Table of Contents
Subpart A_Introduction
Sec.
2.1 Statutory authority for confidentiality of drug abuse patient
records.
2.2 Statutory authority for confidentiality of alcohol abuse patient
records.
2.3 Purpose and effect.
2.4 Criminal penalty for violation.
2.5 Reports of violations.
Subpart B_General Provisions
2.11 Definitions.
2.12 Applicability.
2.13 Confidentiality restrictions.
2.14 Minor patients.
2.15 Incompetent and deceased patients.
2.16 Security for written records.
2.17 Undercover agents and informants.
2.18 Restrictions on the use of identification cards.
2.19 Disposition of records by discontinued programs.
2.20 Relationship to State laws.
2.21 Relationship to Federal statutes protecting research subjects
against compulsory disclosure of their identity.
2.22 Notice to patients of Federal confidentiality requirements.
2.23 Patient access and restrictions on use.
Subpart C_Disclosures With Patient's Consent
2.31 Form of written consent.
2.32 Prohibition on redisclosure.
2.33 Disclosures permitted with written consent.
2.34 Disclosures to prevent multiple enrollments in detoxification and
maintenance treatment programs.
2.35 Disclosures to elements of the criminal justice system which have
referred patients.
Subpart D_Disclosures Without Patient Consent
2.51 Medical emergencies.
2.52 Research activities.
2.53 Audit and evaluation activities.
Subpart E_Court Orders Authorizing Disclosure and Use
2.61 Legal effect of order.
2.62 Order not applicable to records disclosed without consent to
researchers, auditors and evaluators.
2.63 Confidential communications.
2.64 Procedures and criteria for orders authorizing disclosures for
noncriminal purposes.
2.65 Procedures and criteria for orders authorizing disclosure and use
of records to criminally investigate or prosecute patients.
2.66 Procedures and criteria for orders authorizing disclosure and use
of records to investigate or prosecute a program or the person
holding the records.
2.67 Orders authorizing the use of undercover agents and informants to
criminally investigate employees or agents of a program.
Authority: Sec. 408 of Pub. L. 92-255, 86 Stat. 79, as amended by
sec. 303 (a), (b) of Pub L. 93-282, 83 Stat. 137, 138; sec. 4(c)(5)(A)
of Pub. L. 94-237, 90 Stat. 244; sec. 111(c)(3) of Pub. L. 94-581, 90
Stat. 2852; sec. 509 of Pub. L. 96-88, 93 Stat. 695; sec. 973(d) of Pub.
L. 97-35, 95 Stat. 598; and transferred to sec. 527 of the Public Health
Service Act by sec. 2(b)(16)(B) of Pub. L. 98-24, 97 Stat. 182 and as
amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290ee-3)
and sec. 333 of Pub. L. 91-616, 84 Stat. 1853, as amended by sec. 122(a)
of Pub. L. 93-282, 88 Stat. 131; and sec. 111(c)(4) of Pub. L. 94-581,
90 Stat. 2852 and transferred to sec. 523 of the Public Health Service
Act by sec. 2(b)(13) of Pub. L. 98-24, 97 Stat. 181 and as amended by
sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290dd-3), as
amended by sec. 131 of Pub. L. 102-321, 106 Stat. 368, (42 U.S.C. 290dd-
2).
Source: 52 FR 21809, June 9, 1987, unless otherwise noted.
Subpart A_Introduction
Sec. 2.1 Statutory authority for confidentiality of drug abuse patient
records.
The restrictions of these regulations upon the disclosure and use of
drug abuse patient records were initially authorized by section 408 of
the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 U.S.C.
1175). That section as amended was transferred by Pub. L. 98-24 to
section 527 of the Public Health Service Act which is codified
[[Page 8]]
at 42 U.S.C. 290ee-3. The amended statutory authority is set forth
below:
Sec. 290ee-3. Confidentiality of patient records.
(a) Disclosure authorization
Records of the identity, diagnosis, prognosis, or treatment of any
patient which are maintained in connection with the performance of any
drug abuse prevention function conducted, regulated, or directly or
indirectly assisted by any department or agency of the United States
shall, except as provided in subsection (e) of this section, be
confidential and be disclosed only for the purposes and under the
circumstances expressly authorized under subsection (b) of this section.
(b) Purposes and circumstances of disclosure affecting consenting
patient and patient regardless of consent
(1) The content of any record referred to in subsection (a) of this
section 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) of this
section.
(2) Whether or not the patient, with respect to whom any given
record referred to in subsection (a) of this section is maintained,
gives his 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. 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) Prohibition against use of record in making criminal charges or
investigation of patient
Except as authorized by a court order granted under subsection
(b)(2)(C) of this section, no record referred to in subsection (a) of
this section may be used to initiate or substantiate any criminal
charges against a patient or to conduct any investigation of a patient.
(d) Continuing prohibition against disclosure irrespective of status
as patient
The prohibitions of this section continue to apply to records
concerning any individual who has been a patient, irrespective of
whether or when he ceases to be a patient.
(e) Armed Forces and Veterans' Administration; interchange of
records; report of suspected child abuse and neglect to State or local
authorities
The prohibitions of this section do not apply to any interchange of
records--
(1) within the Armed Forces or witrhin those components of the
Veterans' Administration furnishing health care to veterans, or
(2) between such components and the Armed Forces.
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) Penalty for first and subsequent offenses
Any person who violates any provision of this section or any
regulation issued pursuant to this section shall be fined not more than
$500 in the case of a first offense, and not nore than $5,000 in the
case of each subsequent offense.
(g) Regulations; interagency consultations; definitions, safeguards,
and procedures, including procedures and criteria for issuance and scope
of orders
Except as provided in subsection (h) of this section, the Secretary,
after consultation with the Administrator of Veterans' Affairs and the
heads of other Federal departments and agencies substantially affected
thereby, shall prescribe regulations to carry out the purposes of this
section. These 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) of this
section, 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.
(Subsection (h) was superseded by section 111(c)(3) of Pub. L. 94-581.
The responsibility of the Administrator of Veterans' Affairs to write
regulations to provide for confidentiality of drug abuse patient records
under Title 38 was moved from 21 U.S.C. 1175 to 38 U.S.C. 4134.)
Sec. 2.2 Statutory authority for confidentiality of alcohol abuse
patient records.
The restrictions of these regulations upon the disclosure and use of
alcohol
[[Page 9]]
abuse patient records were initially authorized by section 333 of the
Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and
Rehabilitation Act of 1970 (42 U.S.C. 4582). The section as amended was
transferred by Pub. L. 98-24 to section 523 of the Public Health Service
Act which is codified at 42 U.S.C. 290dd-3. The amended statutory
authority is set forth below:
Sec. 290dd-3. Confidentiality of patient records
(a) Disclosure authorization
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 alcoholism or alcohol abuse education,
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)
of this section, be confidential and be disclosed only for the purposes
and under the circumstances expressly authorized under subsection (b) of
this section.
(b) Purposes and circumstances of disclosure affecting consenting
patient and patient regardless of consent
(1) The content of any record referred to in subsection (a) of this
section 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) of this
section.
(2) Whether or not the patient, with respect to whom any given
record referred to in subsection (a) of this section is maintained,
gives his 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. 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) Prohibition against use of record in making criminal charges or
investigation of patient
Except as authorized by a court order granted under subsection
(b)(2)(C) of this section, no record referred to in subsection (a) of
this section may be used to initiate or substantiate any criminal
charges against a patient or to conduct any investigation of a patient.
(d) Continuing prohibition against disclosure irrespective of status
as patient
The prohibitions of this section continue to apply to records
concerning any individual who has been a patient, irrespective of
whether or when he ceases to be a patient.
(e) Armed Forces and Veterans' Administration; interchange of record
of suspected child abuse and neglect to State or local authorities
The prohibitions of this section do not apply to any interchange of
records--
(1) within the Armed Forces or within those components of the
Veterans' Administration furnishing health care to veterans, or
(2) between such components and the Armed Forces.
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) Penalty for first and subsequent offenses
Any person who violates any provision of this section or any
regulation issued pursuant to this section shall be fined not more than
$500 in the case of a first offense, and not more than $5,000 in the
case of each subsequent offense.
(g) Regulations of Secretary; definitions, safeguards, and
procedures, including procedures and criteria for issuance and scope of
orders
Except as provided in subsection (h) of this section, the Secretary
shall prescribe regulations to carry out the purposes of this section.
These 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) of this section,
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.
(Subsection (h) was superseded by section 111(c)(4) of Pub. L. 94-581.
The responsibility of the Administrator of Veterans' Affairs to write
regulations to provide for confidentiality of alcohol abuse patient
records under Title 38 was moved from 42 U.S.C. 4582 to 38 U.S.C. 4134.)
[[Page 10]]
Sec. 2.3 Purpose and effect.
(a) Purpose. Under the statutory provisions quoted in Sec. Sec. 2.1
and 2.2, these regulations impose restrictions upon the disclosure and
use of alcohol and drug abuse patient records which are maintained in
connection with the performance of any federally assisted alcohol and
drug abuse program. The regulations specify:
(1) Definitions, applicability, and general restrictions in subpart
B (definitions applicable to Sec. 2.34 only appear in that section);
(2) Disclosures which may be made with written patient consent and
the form of the written consent in subpart C;
(3) Disclosures which may be made without written patient consent or
an authorizing court order in subpart D; and
(4) Disclosures and uses of patient records which may be made with
an authorizing court order and the procedures and criteria for the entry
and scope of those orders in subpart E.
(b) Effect. (1) These regulations prohibit the disclosure and use of
patient records unless certain circumstances exist. If any circumstances
exists under which disclosure is permitted, that circumstance acts to
remove the prohibition on disclosure but it does not compel disclosure.
Thus, the regulations do not require disclosure under any circumstances.
(2) These regulations are not intended to direct the manner in which
substantive functions such as research, treatment, and evaluation are
carried out. They are intended to insure that an alcohol or drug abuse
patient in a federally assisted alcohol or drug abuse program is not
made more vulnerable by reason of the availability of his or her patient
record than an individual who has an alcohol or drug problem and who
does not seek treatment.
(3) Because there is a criminal penalty (a fine--see 42 U.S.C.
290ee-3(f), 42 U.S.C. 290dd-3(f) and 42 CFR 2.4) for violating the
regulations, they are to be construed strictly in favor of the potential
violator in the same manner as a criminal statute (see M. Kraus &
Brothers v. United States, 327 U.S. 614, 621-22, 66 S. Ct. 705, 707-08
(1946)).
Sec. 2.4 Criminal penalty for violation.
Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(f), any person who
violates any provision of those statutes or these regulations shall be
fined not more than $500 in the case of a first offense, and not more
than $5,000 in the case of each subsequent offense.
Sec. 2.5 Reports of violations.
(a) The report of any violation of these regulations may be directed
to the United States Attorney for the judicial district in which the
violation occurs.
(b) The report of any violation of these regulations by a methadone
program may be directed to the Regional Offices of the Food and Drug
Administration.
Subpart B_General Provisions
Sec. 2.11 Definitions.
For purposes of these regulations:
Alcohol abuse means the use of an alcoholic beverage which impairs
the physical, mental, emotional, or social well-being of the user.
Drug abuse means the use of a psychoactive substance for other than
medicinal purposes which impairs the physical, mental, emotional, or
social well-being of the user.
Diagnosis means any reference to an individual's alcohol or drug
abuse or to a condition which is identified as having been caused by
that abuse which is made for the purpose of treatment or referral for
treatment.
Disclose or disclosure means a communication of patient indentifying
information, the affirmative verification of another person's
communication of patient identifying information, or the communication
of any information from the record of a patient who has been identified.
Informant means an individual:
(a) Who is a patient or employee of a program or who becomes a
patient or employee of a program at the request of a law enforcement
agency or official: and
(b) Who at the request of a law enforcement agency or official
observes one or more patients or employees of
[[Page 11]]
the program for the purpose of reporting the information obtained to the
law enforcement agency or official.
Patient means any individual who has applied for or been given
diagnosis or treatment for alcohol or drug abuse at a federally assisted
program and includes any individual who, after arrest on a criminal
charge, is identified as an alcohol or drug abuser in order to determine
that individual's eligibility to participate in a program.
Patient identifying information means the name, address, social
security number, fingerprints, photograph, or similar information by
which the identity of a patient can be determined with reasonable
accuracy and speed either directly or by reference to other publicly
available information. The term does not include a number assigned to a
patient by a program, if that number does not consist of, or contain
numbers (such as a social security, or driver's license number) which
could be used to identify a patient with reasonable accuracy and speed
from sources external to the program.
Person means an individual, partnership, corporation, Federal, State
or local government agency, or any other legal entity.
Program means:
(a) An individual or entity (other than a general medical care
facility) who holds itself out as providing, and provides, alcohol or
drug abuse diagnosis, treatment or referral for treatment; or
(b) An identified unit within a general medical facility which holds
itself out as providing, and provides, alcohol or drug abuse diagnosis,
treatment or referral for treatment; or
(c) Medical personnel or other staff in a general medical care
facility whose primary function is the provision of alcohol or drug
abuse diagnosis, treatment or referral for treatment and who are
identified as such providers. (See Sec. 2.12(e)(1) for examples.)
Program director means:
(a) In the case of a program which is an individual, that
individual:
(b) In the case of a program which is an organization, the
individual designated as director, managing director, or otherwise
vested with authority to act as chief executive of the organization.
Qualified service organization means a person which:
(a) Provides services to a program, such as data processing, bill
collecting, dosage preparation, laboratory analyses, or legal, medical,
accounting, or other professional services, or services to prevent or
treat child abuse or neglect, including training on nutrition and child
care and individual and group therapy, and
(b) Has entered into a written agreement with a program under which
that person:
(1) Acknowledges that in receiving, storing, processing or otherwise
dealing with any patient records from the progams, it is fully bound by
these regulations; and
(2) If necessary, will resist in judicial proceedings any efforts to
obtain access to patient records except as permitted by these
regulations.
Records means any information, whether recorded or not, relating to
a patient received or acquired by a federally assisted alcohol or drug
program.
Third party payer means a person who pays, or agrees to pay, for
diagnosis or treatment furnished to a patient on the basis of a
contractual relationship with the patient or a member of his family or
on the basis of the patient's eligibility for Federal, State, or local
governmental benefits.
Treatment means the management and care of a patient suffering from
alcohol or drug abuse, a condition which is identified as having been
caused by that abuse, or both, in order to reduce or eliminate the
adverse effects upon the patient.
Undercover agent means an officer of any Federal, State, or local
law enforcement agency who enrolls in or becomes an employee of a
program for the purpose of investigating a suspected violation of law or
who pursues that purpose after enrolling or becoming employed for other
purposes.
[52 FR 21809, June 9, 1987, as amended at 60 FR 22297, May 5, 1995]
Sec. 2.12 Applicability.
(a) General--(1) Restrictions on disclosure. The restrictions on
disclosure in
[[Page 12]]
these regulations apply to any information, whether or not recorded,
which:
(i) Would identify a patient as an alcohol or drug abuser either
directly, by reference to other publicly available information, or
through verification of such an identification by another person; and
(ii) Is drug abuse information obtained by a federally assisted drug
abuse program after March 20, 1972, or is alcohol abuse information
obtained by a federally assisted alcohol abuse program after May 13,
1974 (or if obtained before the pertinent date, is maintained by a
federally assisted alcohol or drug abuse program after that date as part
of an ongoing treatment episode which extends past that date) for the
purpose of treating alcohol or drug abuse, making a diagnosis for that
treatment, or making a referral for that treatment.
(2) Restriction on use. The restriction on use of information to
initiate or substantiate any criminal charges against a patient or to
conduct any criminal investigation of a patient (42 U.S.C. 290ee-3(c),
42 U.S.C. 290dd-3(c)) applies to any information, whether or not
recorded which is drug abuse information obtained by a federally
assisted drug abuse program after March 20, 1972, or is alcohol abuse
information obtained by a federally assisted alcohol abuse program after
May 13, 1974 (or if obtained before the pertinent date, is maintained by
a federally assisted alcohol or drug abuse program after that date as
part of an ongoing treatment episode which extends past that date), for
the purpose of treating alcohol or drug abuse, making a diagnosis for
the treatment, or making a referral for the treatment.
(b) Federal assistance. An alcohol abuse or drug abuse program is
considered to be federally assisted if:
(1) It is conducted in whole or in part, whether directly or by
contract or otherwise by any department or agency of the United States
(but see paragraphs (c)(1) and (c)(2) of this section relating to the
Veterans' Administration and the Armed Forces);
(2) It is being carried out under a license, certification,
registration, or other authorization granted by any department or agency
of the United States including but not limited to:
(i) Certification of provider status under the Medicare program;
(ii) Authorization to conduct methadone maintenance treatment (see
21 CFR 291.505); or
(iii) Registration to dispense a substance under the Controlled
Substances Act to the extent the controlled substance is used in the
treatment of alcohol or drug abuse;
(3) It is supported by funds provided by any department or agency of
the United States by being:
(i) A recipient of Federal financial assistance in any form,
including financial assistance which does not directly pay for the
alcohol or drug abuse diagnosis, treatment, or referral activities; or
(ii) Conducted by a State or local government unit which, through
general or special revenue sharing or other forms of assistance,
receives Federal funds which could be (but are not necessarily) spent
for the alcohol or drug abuse program; or
(4) It is assisted by the Internal Revenue Service of the Department
of the Treasury through the allowance of income tax deductions for
contributions to the program or through the granting of tax exempt
status to the program.
(c) Exceptions--(1) Veterans' Administration. These regulations do
not apply to information on alcohol and drug abuse patients maintained
in connection with the Veterans' Administration provisions of hospital
care, nursing home care, domiciliary care, and medical services under
title 38, United States Code. Those records are governed by 38 U.S.C.
4132 and regulations issued under that authority by the Administrator of
Veterans' Affairs.
(2) Armed Forces. These regulations apply to any information
described in paragraph (a) of this section which was obtained by any
component of the Armed Forces during a period when the patient was
subject to the Uniform Code of Military Justice except:
(i) Any interchange of that information within the Armed Forces; and
(ii) Any interchange of that information between the Armed Forces
and
[[Page 13]]
those components of the Veterans Administration furnishing health care
to veterans.
(3) Communication within a program or between a program and an
entity having direct administrative control over that program. The
restrictions on disclosure in these regulations do not apply to
communications of information between or among personnel having a need
for the information in connection with their duties that arise out of
the provision of diagnosis, treatment, or referral for treatment of
alcohol or drug abuse if the communications are
(i) Within a program or
(ii) Between a program and an entity that has direct administrative
control over the program.
(4) Qualified Service Organizations. The restrictions on disclosure
in these regulations do not apply to communications between a program
and a qualified service organization of information needed by the
organization to provide services to the program.
(5) Crimes on program premises or against program personnel. The
restrictions on disclosure and use in these regulations do not apply to
communications from program personnel to law enforcement officers
which--
(i) Are directly related to a patient's commission of a crime on the
premises of the program or against program personnel or to a threat to
commit such a crime; and
(ii) Are limited to the circumstances of the incident, including the
patient status of the individual committing or threatening to commit the
crime, that individual's name and address, and that individual's last
known whereabouts.
(6) Reports of suspected child abuse and neglect. The restrictions
on disclosure and use in these regulations do not apply to the reporting
under State law of incidents of suspected child abuse and neglect to the
appropriate State or local authorities. However, the restrictions
continue to apply to the original alcohol or drug abuse patient records
maintained by the program including their disclosure and use for civil
or criminal proceedings which may arise out of the report of suspected
child abuse and neglect.
(d) Applicability to recipients of information--(1) Restriction on
use of information. The restriction on the use of any information
subject to these regulations to initiate or substantiate any criminal
charges against a patient or to conduct any criminal investigation of a
patient applies to any person who obtains that information from a
federally assisted alcohol or drug abuse program, regardless of the
status of the person obtaining the information or of whether the
information was obtained in accordance with these regulations. This
restriction on use bars, among other things, the introduction of that
information as evidence in a criminal proceeding and any other use of
the information to investigate or prosecute a patient with respect to a
suspected crime. Information obtained by undercover agents or informants
(see Sec. 2.17) or through patient access (see Sec. 2.23) is subject
to the restriction on use.
(2) Restrictions on disclosures--Third party payers, administrative
entities, and others. The restrictions on disclosure in these
regulations apply to:
(i) Third party payers with regard to records disclosed to them by
federally assisted alcohol or drug abuse programs;
(ii) Entities having direct administrative control over programs
with regard to information communicated to them by the program under
Sec. 2.12(c)(3); and
(iii) Persons who receive patient records directly from a federally
assisted alcohol or drug abuse program and who are notified of the
restrictions on redisclosure of the records in accordance with Sec.
2.32 of these regulations.
(e) Explanation of applicability--(1) Coverage. These regulations
cover any information (including information on referral and intake)
about alcohol and drug abuse patients obtained by a program (as the
terms ``patient'' and ``program'' are defined in Sec. 2.11) if the
program is federally assisted in any manner described in Sec. 2.12(b).
Coverage includes, but is not limited to, those treatment or
rehabilitation programs, employee assistance programs, programs within
general hospitals, school-based programs, and private practitioners who
hold themselves out as
[[Page 14]]
providing, and provide alcohol or drug abuse diagnosis, treatment, or
referral for treatment. However, these regulations would not apply, for
example, to emergency room personnel who refer a patient to the
intensive care unit for an apparent overdose, unless the primary
function of such personnel is the provision of alcohol or drug abuse
diagnosis, treatment or referral and they are identified as providing
such services or the emergency room has promoted itself to the community
as a provider of such services.
(2) Federal assistance to program required. If a patient's alcohol
or drug abuse diagnosis, treatment, or referral for treatment is not
provided by a program which is federally conducted, regulated or
supported in a manner which constitutes Federal assistance under Sec.
2.12(b), that patient's record is not covered by these regulations.
Thus, it is possible for an individual patient to benefit from Federal
support and not be covered by the confidentiality regulations because
the program in which the patient is enrolled is not federally assisted
as defined in Sec. 2.12(b). For example, if a Federal court placed an
individual in a private for-profit program and made a payment to the
program on behalf of that individual, that patient's record would not be
covered by these regulations unless the program itself received Federal
assistance as defined by Sec. 2.12(b).
(3) Information to which restrictions are applicable. Whether a
restriction is on use or disclosure affects the type of information
which may be available. The restrictions on disclosure apply to any
information which would identify a patient as an alcohol or drug abuser.
The restriction on use of information to bring criminal charges against
a patient for a crime applies to any information obtained by the program
for the purpose of diagnosis, treatment, or referral for treatment of
alcohol or drug abuse. (Note that restrictions on use and disclosure
apply to recipients of information under Sec. 2.12(d).)
(4) How type of diagnosis affects coverage. These regulations cover
any record of a diagnosis identifying a patient as an alcohol or drug
abuser which is prepared in connection with the treatment or referral
for treatment of alcohol or drug abuse. A diagnosis prepared for the
purpose of treatment or referral for treatment but which is not so used
is covered by these regulations. The following are not covered by these
regulations:
(i) Diagnosis which is made solely for the purpose of providing
evidence for use by law enforcement authorities; or
(ii) A diagnosis of drug overdose or alcohol intoxication which
clearly shows that the individual involved is not an alcohol or drug
abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to a
prescribed dosage of one or more drugs).
[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987, as amended at 60
FR 22297, May 5, 1995]
Sec. 2.13 Confidentiality restrictions.
(a) General. The patient records to which these regulations apply
may be disclosed or used only as permitted by these regulations and may
not otherwise be disclosed or used in any civil, criminal,
administrative, or legislative proceedings conducted by any Federal,
State, or local authority. Any disclosure made under these regulations
must be limited to that information which is necessary to carry out the
purpose of the disclosure.
(b) Unconditional compliance required. The restrictions on
disclosure and use in these regulations apply whether the holder of the
information believes that the person seeking the information already has
it, has other means of obtaining it, is a law enforcement or other
official, has obtained a subpoena, or asserts any other justification
for a disclosure or use which is not permitted by these regulations.
(c) Acknowledging the presence of patients: Responding to requests.
(1) The presence of an identified patient in a facility or component of
a facility which is publicly identified as a place where only alcohol or
drug abuse diagnosis, treatment, or referral is provided may be
acknowledged only if the patient's written consent is obtained in
accordance with subpart C of these regulations or if an authorizing
court order is entered in accordance with subpart E of these
regulations. The regulations permit acknowledgement of the presence of
an identified patient in a facility or part of a facility if the
[[Page 15]]
facility is not publicy identified as only an alcohol or drug abuse
diagnosis, treatment or referral facility, and if the acknowledgement
does not reveal that the patient is an alcohol or drug abuser.
(2) Any answer to a request for a disclosure of patient records
which is not permissible under these regulations must be made in a way
that will not affirmatively reveal that an identified individual has
been, or is being diagnosed or treated for alcohol or drug abuse. An
inquiring party may be given a copy of these regulations and advised
that they restrict the disclosure of alcohol or drug abuse patient
records, but may not be told affirmatively that the regulations restrict
the disclosure of the records of an identified patient. The regulations
do not restrict a disclosure that an identified individual is not and
never has been a patient.
Sec. 2.14 Minor patients.
(a) Definition of minor. As used in these regulations the term
``minor'' means a person who has not attained the age of majority
specified in the applicable State law, or if no age of majority is
specified in the applicable State law, the age of eighteen years.
(b) State law not requiring parental consent to treatment. If a
minor patient acting alone has the legal capacity under the applicable
State law to apply for and obtain alcohol or drug abuse treatment, any
written consent for disclosure authorized under subpart C of these
regulations may be given only by the minor patient. This restriction
includes, but is not limited to, any disclosure of patient identifying
information to the parent or guardian of a minor patient for the purpose
of obtaining financial reimbursement. These regulations do not prohibit
a program from refusing to provide treatment until the minor patient
consents to the disclosure necessary to obtain reimbursement, but
refusal to provide treatment may be prohibited under a State or local
law requiring the program to furnish the service irrespective of ability
to pay.
(c) State law requiring parental consent to treatment. (1) Where
State law requires consent of a parent, guardian, or other person for a
minor to obtain alcohol or drug abuse treatment, any written consent for
disclosure authorized under subpart C of these regulations must be given
by both the minor and his or her parent, guardian, or other person
authorized under State law to act in the minor's behalf.
(2) Where State law requires parental consent to treatment the fact
of a minor's application for treatment may be communicated to the
minor's parent, guardian, or other person authorized under State law to
act in the minor's behalf only if:
(i) The minor has given written consent to the disclosure in
accordance with subpart C of these regulations or
(ii) The minor lacks the capacity to make a rational choice
regarding such consent as judged by the program director under paragraph
(d) of this section.
(d) Minor applicant for services lacks capacity for rational choice.
Facts relevant to reducing a threat to the life or physical well being
of the applicant or any other individual may be disclosed to the parent,
guardian, or other person authorized under State law to act in the
minor's behalf if the program director judges that:
(1) A minor applicant for services lacks capacity because of extreme
youth or mental or physical condition to make a rational decision on
whether to consent to a disclosure under subpart C of these regulations
to his or her parent, guardian, or other person authorized under State
law to act in the minor's behalf, and
(2) The applicant's situation poses a substantial threat to the life
or physical well being of the applicant or any other individual which
may be reduced by communicating relevant facts to the minor's parent,
guardian, or other person authorized under State law to act in the
minor's behalf.
Sec. 2.15 Incompetent and deceased patients.
(a) Incompetent patients other than minors--(1) Adjudication of
incompetence. In the case of a patient who has been adjudicated as
lacking the capacity, for any reason other than insufficient age, to
manage his or her own affairs, any consent which is required under these
regulations may be given by the
[[Page 16]]
guardian or other person authorized under State law to act in the
patient's behalf.
(2) No adjudication of incompetency. For any period for which the
program director determines that a patient, other than a minor or one
who has been adjudicated incompetent, suffers from a medical condition
that prevents knowing or effective action on his or her own behalf, the
program director may exercise the right of the patient to consent to a
disclosure under subpart C of these regulations for the sole purpose of
obtaining payment for services from a third party payer.
(b) Deceased patients--(1) Vital statistics. These regulations do
not restrict the disclosure of patient identifying information relating
to the cause of death of a patient under laws requiring the collection
of death or other vital statistics or permitting inquiry into the cause
of death.
(2) Consent by personal representative. Any other disclosure of
information identifying a deceased patient as an alcohol or drug abuser
is subject to these regulations. If a written consent to the disclosure
is required, that consent may be given by an executor, administrator, or
other personal representative appointed under applicable State law. If
there is no such appointment the consent may be given by the patient's
spouse or, if none, by any responsible member of the patient's family.
Sec. 2.16 Security for written records.
(a) Written records which are subject to these regulations must be
maintained in a secure room, locked file cabinet, safe or other similar
container when not in use; and
(b) Each program shall adopt in writing procedures which regulate
and control access to and use of written records which are subject to
these regulations.
Sec. 2.17 Undercover agents and informants.
(a) Restrictions on placement. Except as specifically authorized by
a court order granted under Sec. 2.67 of these regulations, no program
may knowingly employ, or enroll as a patient, any undercover agent or
informant.
(b) Restriction on use of information. No information obtained by an
undercover agent or informant, whether or not that undercover agent or
informant is placed in a program pursuant to an authorizing court order,
may be used to criminally investigate or prosecute any patient.
[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]
Sec. 2.18 Restrictions on the use of identification cards.
No person may require any patient to carry on his or her person
while away from the program premises any card or other object which
would identify the patient as an alcohol or drug abuser. This section
does not prohibit a person from requiring patients to use or carry cards
or other identification objects on the premises of a program.
Sec. 2.19 Disposition of records by discontinued programs.
(a) General. If a program discontinues operations or is taken over
or acquired by another program, it must purge patient identifying
information from its records or destroy the records unless--
(1) The patient who is the subject of the records gives written
consent (meeting the requirements of Sec. 2.31) to a transfer of the
records to the acquiring program or to any other program designated in
the consent (the manner of obtaining this consent must minimize the
likelihood of a disclosure of patient identifying information to a third
party); or
(2) There is a legal requirement that the records be kept for a
period specified by law which does not expire until after the
discontinuation or acquisition of the program.
(b) Procedure where retention period required by law. If paragraph
(a)(2) of this section applies, the records must be:
(1) Sealed in envelopes or other containers labeled as follows:
``Records of [insert name of program] required to be maintained under
[insert citation to statute, regulation, court order or other legal
authority requiring that records be kept] until a date not later than
[insert appropriate date]''; and
(2) Held under the restrictions of these regulations by a
responsible person who must, as soon as practicable
[[Page 17]]
after the end of the retention period specified on the label, destroy
the records.
Sec. 2.20 Relationship to State laws.
The statutes authorizing these regulations (42 U.S.C. 290ee-3 and 42
U.S.C. 290dd-3) do not preempt the field of law which they cover to the
exclusion of all State laws in that field. If a disclosure permitted
under these regulations is prohibited under State law, neither these
regulations nor the authorizing statutes may be construed to authorize
any violation of that State law. However, no State law may either
authorize or compel any disclosure prohibited by these regulations.
Sec. 2.21 Relationship to Federal statutes protecting research subjects
against compulsory disclosure of their identity.
(a) Research privilege description. There may be concurrent coverage
of patient identifying information by these regulations and by
administrative action taken under: Section 303(a) of the Public Health
Service Act (42 U.S.C. 242a(a) and the implementing regulations at 42
CFR part 2a); or section 502(c) of the Controlled Substances Act (21
U.S.C. 872(c) and the implementing regulations at 21 CFR 1316.21). These
``research privilege'' statutes confer on the Secretary of Health and
Human Services and on the Attorney General, respectively, the power to
authorize researchers conducting certain types of research to withhold
from all persons not connected with the research the names and other
identifying information concerning individuals who are the subjects of
the research.
(b) Effect of concurrent coverage. These regulations restrict the
disclosure and use of information about patients, while administrative
action taken under the research privilege statutes and implementing
regulations protects a person engaged in applicable research from being
compelled to disclose any identifying characteristics of the individuals
who are the subjects of that research. The issuance under subpart E of
these regulations of a court order authorizing a disclosure of
information about a patient does not affect an exercise of authority
under these research privilege statutes. However, the research privilage
granted under 21 CFR 291.505(g) to treatment programs using methadone
for maintenance treatment does not protect from compulsory disclosure
any imformation which is permitted to be disclosed under those
regulations. Thus, if a court order entered in accordance with subpart E
of these regulations authorizes a methadone maintenance treatment
program to disclose certain information about its patients, that program
may not invoke the research privilege under 21 CFR 291.505(g) as a
defense to a subpoena for that information.
Sec. 2.22 Notice to patients of Federal confidentiality requirements.
(a) Notice required. At the time of admission or as soon threreafter
as the patient is capable of rational communication, each program shall:
(1) Communicate to the patient that Federal law and regulations
protect the confidentiality of alcohol and drug abuse patient records;
and
(2) Give to the patient a summary in writing of the Federal law and
regulations.
(b) Required elements of written summary. The written summary of the
Federal law and regulations must include:
(1) A general description of the limited circumstances under which a
program may acknowledge that an individual is present at a facility or
disclose outside the program information identifying a patient as an
alcohol or drug abuser.
(2) A statement that violation of the Federal law and regulations by
a program is a crime and that suspected violations may be reported to
appropriate authorities in accordance with these regulations.
(3) A statement that information related to a patient's commission
of a crime on the premises of the program or against personnel of the
program is not protected.
(4) A statement that reports of suspected child abuse and neglect
made under State law to appropriate State or local authorities are not
protected.
(5) A citation to the Federal law and regulations.
(c) Program options. The program may devise its own notice or may
use the
[[Page 18]]
sample notice in paragraph (d) to comply with the requirement to provide
the patient with a summary in writing of the Federal law and
regulations. In addition, the program may include in the written summary
information concerning State law and any program policy not inconsistent
with State and Federal law on the subject of confidentiality of alcohol
and drug abuse patient records.
(d) Sample notice.
Confidentiality of Alcohol and Drug Abuse Patient Records
The confidentiality of alcohol and drug abuse patient records
maintained by this program is protected by Federal law and regulations.
Generally, the program may not say to a person outside the program that
a patient attends the program, or disclose any information identifying a
patient as an alcohol or drug abuser Unless:
(1) The patient consents in writing:
(2) The disclosure is allowed by a court order; or
(3) The disclosure is made to medical personnel in a medical
emergency or to qualified personnel for research, audit, or program
evaluation.
Violation of the Federal law and regulations by a program is a
crime. Suspected violations may be reported to appropriate authorities
in accordance with Federal regulations.
Federal law and regulations do not protect any information about a
crime committed by a patient either at the program or against any person
who works for the program or about any threat to commit such a crime.
Federal laws and regulations do not protect any information about
suspected child abuse or neglect from being reported under State law to
appropriate State or local authorities.
(See 42 U.S.C. 290dd-3 and 42 U.S.C. 290ee-3 for Federal laws and 42 CFR
part 2 for Federal regulations.)
(Approved by the Office of Management and Budget under control number
0930-0099)
Sec. 2.23 Patient access and restrictions on use.
(a) Patient access not prohibited. These regulations do not prohibit
a program from giving a patient access to his or her own records,
including the opportunity to inspect and copy any records that the
program maintains about the patient. The program is not required to
obtain a patient's written consent or other authorization under these
regulations in order to provide such access to the patient.
(b) Restriction on use of information. Information obtained by
patient access to his or her patient record is subject to the
restriction on use of his information to initiate or substantiate any
criminal charges against the patient or to conduct any criminal
investigation of the patient as provided for under Sec. 2.12(d)(1).
Subpart C_Disclosures With Patient's Consent
Sec. 2.31 Form of written consent.
(a) Required elements. A written consent to a disclosure under these
regulations must include:
(1) The specific name or general designation of the program or
person permitted to make the disclosure.
(2) The name or title of the individual or the name of the
organization to which disclosure is to be made.
(3) The name of the patient.
(4) The purpose of the disclosure.
(5) How much and what kind of information is to be disclosed.
(6) The signature of the patient and, when required for a patient
who is a minor, the signature of a person authorized to give consent
under Sec. 2.14; or, when required for a patient who is incompetent or
deceased, the signature of a person authorized to sign under Sec. 2.15
in lieu of the patient.
(7) The date on which the consent is signed.
(8) A statement that the consent is subject to revocation at any
time except to the extent that the program or person which is to make
the disclosure has already acted in reliance on it. Acting in reliance
includes the provision of treatment services in reliance on a valid
consent to disclose information to a third party payer.
(9) The date, event, or condition upon which the consent will expire
if not revoked before. This date, event, or condition must insure that
the consent will last no longer than reasonably necessary to serve the
purpose for which it is given.
(b) Sample consent form. The following form complies with paragraph
(a) of this section, but other elements may be added.
[[Page 19]]
1. I (name of patient) [squ] Request [squ] Authorize:
2. (name or general designation of program which is to make the
disclosure)
________________________________________________________________________
3. To disclose: (kind and amount of information to be disclosed)
________________________________________________________________________
4. To: (name or title of the person or organization to which disclosure
is to be made)
________________________________________________________________________
5. For (purpose of the disclosure)
________________________________________________________________________
6. Date (on which this consent is signed)
________________________________________________________________________
7. Signature of patient
________________________________________________________________________
8. Signature of parent or guardian (where required)
________________________________________________________________________
9. Signature of person authorized to sign in lieu of the patient (where
required)
________________________________________________________________________
10. This consent is subject to revocation at any time except to the
extent that the program which is to make the disclosure has already
taken action in reliance on it. If not previously revoked, this consent
will terminate upon: (specific date, event, or condition)
(c) Expired, deficient, or false consent. A disclosure may not be
made on the basis of a consent which:
(1) Has expired;
(2) On its face substantially fails to conform to any of the
requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through a reasonable effort could be known, by the
person holding the records to be materially false.
(Approved by the Office of Management and Budget under control number
0930-0099)
Sec. 2.32 Prohibition on redisclosure.
Notice to accompany disclosure. Each disclosure made with the
patient's written consent must be accompanied by the following written
statement:
This information has been disclosed to you from records protected by
Federal confidentiality rules (42 CFR part 2). The Federal rules
prohibit you from making any further disclosure of this information
unless further disclosure is expressly permitted by the written consent
of the person to whom it pertains or as otherwise permitted by 42 CFR
part 2. A general authorization for the release of medical or other
information is NOT sufficient for this purpose. The Federal rules
restrict any use of the information to criminally investigate or
prosecute any alcohol or drug abuse patient.
[52 FR 21809, June 9, 1987; 52 FR 41997, Nov. 2, 1987]
Sec. 2.33 Disclosures permitted with written consent.
If a patient consents to a disclosure of his or her records under
Sec. 2.31, a program may disclose those records in accordance with that
consent to any individual or organization named in the consent, except
that disclosures to central registries and in connection with criminal
justice referrals must meet the requirements of Sec. Sec. 2.34 and
2.35, respectively.
Sec. 2.34 Disclosures to prevent multiple enrollments in detoxification
and maintenance treatment programs.
(a) Definitions. For purposes of this section:
Central registry means an organization which obtains from two or
more member progams patient identifying information about individuals
applying for maintenance treatment or detoxification treatment for the
purpose of avoiding an individual's concurrent enrollment in more than
one program.
Detoxification treatment means the dispensing of a narcotic drug in
decreasing doses to an individual in order to reduce or eliminate
adverse physiological or psychological effects incident to withdrawal
from the sustained use of a narcotic drug.
Maintenance treatment means the dispensing of a narcotic drug in the
treatment of an individual for dependence upon heroin or other morphine-
like drugs.
Member program means a detoxification treatment or maintenance
treatment program which reports patient identifying information to a
central registry and which is in the same State as that central registry
or is not more than 125 miles from any border of the State in which the
central registry is located.
(b) Restrictions on disclosure. A program may disclose patient
records to a central registry or to any detoxification or maintenance
treatment program not more than 200 miles away for the purpose of
preventing the multiple enrollment of a patient only if:
[[Page 20]]
(1) The disclosure is made when:
(i) The patient is accepted for treatment;
(ii) The type or dosage of the drug is changed; or
(iii) The treatment is interrupted, resumed or terminated.
(2) The disclosure is limited to:
(i) Patient identifying information;
(ii) Type and dosage of the drug; and
(iii) Relevant dates.
(3) The disclosure is made with the patient's written consent
meeting the requirements of Sec. 2.31, except that:
(i) The consent must list the name and address of each central
registry and each known detoxification or maintenance treatment program
to which a disclosure will be made; and
(ii) The consent may authorize a disclosure to any detoxification or
maintenance treatment program established within 200 miles of the
program after the consent is given without naming any such program.
(c) Use of information limited to prevention of multiple
enrollments. A central registry and any detoxification or maintenance
treatment program to which information is disclosed to prevent multiple
enrollments may not redisclose or use patient identifying information
for any purpose other than the prevention of multiple enrollments unless
authorized by a court order under subpart E of these regulations.
(d) Permitted disclosure by a central registry to prevent a multiple
enrollment. When a member program asks a central registry if an
identified patient is enrolled in another member program and the
registry determines that the patient is so enrolled, the registry may
disclose--
(1) The name, address, and telephone number of the member program(s)
in which the patient is already enrolled to the inquiring member
program; and
(2) The name, address, and telephone number of the inquiring member
program to the member program(s) in which the patient is already
enrolled. The member programs may communicate as necessary to verify
that no error has been made and to prevent or eliminate any multiple
enrollment.
(e) Permitted disclosure by a detoxification or maintenance
treatment program to prevent a multiple enrollment. A detoxification or
maintenance treatment program which has received a disclosure under this
section and has determined that the patient is already enrolled may
communicate as necessary with the program making the disclosure to
verify that no error has been made and to prevent or eliminate any
multiple enrollment.
Sec. 2.35 Disclosures to elements of the criminal justice system
which have referred patients.
(a) A program may disclose information about a patient to those
persons within the criminal justice system which have made participation
in the program a condition of the disposition of any criminal
proceedings against the patient or of the patient's parole or other
release from custody if:
(1) The disclosure is made only to those individuals within the
criminal justice system who have a need for the information in
connection with their duty to monitor the patient's progress (e.g., a
prosecuting attorney who is withholding charges against the patient, a
court granting pretrial or posttrial release, probation or parole
officers responsible for supervision of the patient); and
(2) The patient has signed a written consent meeting the
requirements of Sec. 2.31 (except paragraph (a)(8) which is
inconsistent with the revocation provisions of paragraph (c) of this
section) and the requirements of paragraphs (b) and (c) of this section.
(b) Duration of consent. The written consent must state the period
during which it remains in effect. This period must be reasonable,
taking into account:
(1) The anticipated length of the treatment;
(2) The type of criminal proceeding involved, the need for the
information in connection with the final disposition of that proceeding,
and when the final disposition will occur; and
(3) Such other factors as the program, the patient, and the
person(s) who will receive the disclosure consider pertinent.
(c) Revocation of consent. The written consent must state that it is
revocable upon the passage of a specified amount of time or the
occurrence of a specified,
[[Page 21]]
ascertainable event. The time or occurrence upon which consent becomes
revocable may be no later than the final disposition of the conditional
release or other action in connection with which consent was given.
(d) Restrictions on redisclosure and use. A person who receives
patient information under this section may redisclose and use it only to
carry out that person's official duties with regard to the patient's
conditional release or other action in connection with which the consent
was given.
Subpart D_Disclosures Without Patient Consent
Sec. 2.51 Medical emergencies.
(a) General Rule. Under the procedures required by paragraph (c) of
this section, patient identifying information may be disclosed to
medical personnel who have a need for information about a patient for
the purpose of treating a condition which poses an immediate threat to
the health of any individual and which requires immediate medical
intervention.
(b) Special Rule. Patient identifying information may be disclosed
to medical personnel of the Food and Drug Administration (FDA) who
assert a reason to believe that the health of any individual may be
threatened by an error in the manufacture, labeling, or sale of a
product under FDA jurisdiction, and that the information will be used
for the exclusive purpose of notifying patients or their physicians of
potential dangers.
(c) Procedures. Immediately following disclosure, the program shall
document the disclosure in the patient's records, setting forth in
writing:
(1) The name of the medical personnel to whom disclosure was made
and their affiliation with any health care facility;
(2) The name of the individual making the disclosure;
(3) The date and time of the disclosure; and
(4) The nature of the emergency (or error, if the report was to
FDA).
(Approved by the Office of Management and Budget under control number
0930-0099)
Sec. 2.52 Research activities.
(a) Patient identifying information may be disclosed for the purpose
of conducting scientific research if the program director makes a
determination that the recipient of the patient identifying information:
(1) Is qualified to conduct the research;
(2) Has a research protocol under which the patient identifying
information:
(i) Will be maintained in accordance with the security requirements
of Sec. 2.16 of these regulations (or more stringent requirements); and
(ii) Will not be redisclosed except as permitted under paragraph (b)
of this section; and
(3) Has provided a satisfactory written statement that a group of
three or more individuals who are independent of the research project
has reviewed the protocol and determined that:
(i) The rights and welfare of patients will be adequately protected;
and
(ii) The risks in disclosing patient identifying information are
outweighed by the potential benefits of the research.
(b) A person conducting research may disclose patient identifying
information obtained under paragraph (a) of this section only back to
the program from which that information was obtained and may not
identify any individual patient in any report of that research or
otherwise disclose patient identities.
[52 FR 21809, June 9, 1987, as amended at 52 FR 41997, Nov. 2, 1987]
Sec. 2.53 Audit and evaluation activities.
(a) Records not copied or removed. If patient records are not copied
or removed, patient identifying information may be disclosed in the
course of a review of records on program premises to any person who
agrees in writing to comply with the limitations on redisclosure and use
in paragraph (d) of this section and who:
(1) Performs the audit or evaluation activity on behalf of:
(i) Any Federal, State, or local governmental agency which provides
financial assistance to the program or is
[[Page 22]]
authorized by law to regulate its activities; or
(ii) Any private person which provides financial assistance to the
program, which is a third party payer covering patients in the program,
or which is a quality improvement organization performing a utilization
or quality control review; or
(2) Is determined by the program director to be qualified to conduct
the audit or evaluation activities.
(b) Copying or removal of records. Records containing patient
identifying information may be copied or removed from program premises
by any person who:
(1) Agrees in writing to:
(i) Maintain the patient identifying information in accordance with
the security requirements provided in Sec. 2.16 of these regulations
(or more stringent requirements);
(ii) Destroy all the patient identifying information upon completion
of the audit or evaluation; and
(iii) Comply with the limitations on disclosure and use in paragraph
(d) of this section; and
(2) Performs the audit or evaluation activity on behalf of:
(i) Any Federal, State, or local governmental agency which provides
financial assistance to the program or is authorized by law to regulate
its activities; or
(ii) Any private person which provides financial assistance to the
program, which is a third part payer covering patients in the program,
or which is a quality improvement organization performing a utilization
or quality control review.
(c) Medicare or Medicaid audit or evaluation. (1) For purposes of
Medicare or Medicaid audit or evaluation under this section, audit or
evaluation includes a civil or administrative investigation of the
program by any Federal, State, or local agency responsible for oversight
of the Medicare or Medicaid program and includes administrative
enforcement, against the program by the agency, of any remedy authorized
by law to be imposed as a result of the findings of the investigation.
(2) Consistent with the definition of program in Sec. 2.11, program
includes an employee of, or provider of medical services under, the
program when the employee or provider is the subject of a civil
investigation or administrative remedy, as those terms are used in
paragraph (c)(1) of this section.
(3) If a disclosure to a person is authorized under this section for
a Medicare or Medicaid audit or evaluation, including a civil
investigation or administrative remedy, as those terms are used in
paragraph (c)(1) of this section, then a quality improvement
organization which obtains the information under paragraph (a) or (b)
may disclose the information to that person but only for purposes of
Medicare or Medicaid audit or evaluation.
(4) The provisions of this paragraph do not authorize the agency,
the program, or any other person to disclose or use patient identifying
information obtained during the audit or evaluation for any purposes
other than those necessary to complete the Medicare or Medicaid audit or
evaluation activity as specified in this paragraph.
(d) Limitations on disclosure and use. Except as provided in
paragraph (c) of this section, patient identifying information disclosed
under this section may be disclosed only back to the program from which
it was obtained and used only to carry out an audit or evaluation
purpose or to investigate or prosecute criminal or other activities, as
authorized by a court order entered under Sec. 2.66 of these
regulations.
Subpart E_Court Orders Authorizing Disclosure and Use
Sec. 2.61 Legal effect of order.
(a) Effect. An order of a court of competent jurisdiction entered
under this subpart is a unique kind of court order. Its only purpose is
to authorize a disclosure or use of patient information which would
otherwise be prohibited by 42 U.S.C. 290ee-3, 42 U.S.C. 290dd-3 and
these regulations. Such an order does not compel disclosure. A subpoena
or a similar legal mandate must be issued in order to compel disclosure.
This mandate may be entered at the same time as and accompany an
authorizing court order entered under these regulations.
[[Page 23]]
(b) Examples. (1) A person holding records subject to these
regulations receives a subpoena for those records: a response to the
subpoena is not permitted under the regulations unless an authorizing
court order is entered. The person may not disclose the records in
response to the subpoena unless a court of competent jurisdiction enters
an authorizing order under these regulations.
(2) An authorizing court order is entered under these regulations,
but the person authorized does not want to make the disclosure. If there
is no subpoena or other compulsory process or a subpoena for the records
has expired or been quashed, that person may refuse to make the
disclosure. Upon the entry of a valid subpoena or other compulsory
process the person authorized to disclose must disclose, unless there is
a valid legal defense to the process other than the confidentiality
restrictions of these regulations.
[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]
Sec. 2.62 Order not applicable to records disclosed without consent
to researchers, auditors and evaluators.
A court order under these regulations may not authorize qualified
personnel, who have received patient identifying information without
consent for the purpose of conducting research, audit or evaluation, to
disclose that information or use it to conduct any criminal
investigation or prosecution of a patient. However, a court order under
Sec. 2.66 may authorize disclosure and use of records to investigate or
prosecute qualified personnel holding the records.
Sec. 2.63 Confidential communications.
(a) A court order under these regulations may authorize disclosure
of confidential communications made by a patient to a program in the
course of diagnosis, treatment, or referral for treatment only if:
(1) The disclosure is necessary to protect against an existing
threat to life or of serious bodily injury, including circumstances
which constitute suspected child abuse and neglect and verbal threats
against third parties;
(2) The disclosure is necessary in connection with investigation or
prosecution of an extremely serious crime, such as one which directly
threatens loss of life or serious bodily injury, including homicide,
rape, kidnapping, armed robbery, assault with a deadly weapon, or child
abuse and neglect; or
(3) The disclosure is in connection with litigation or an
administrative proceeding in which the patient offers testimony or other
evidence pertaining to the content of the confidential communications.
(b) [Reserved]
Sec. 2.64 Procedures and criteria for orders authorizing disclosures
for noncriminal purposes.
(a) Application. An order authorizing the disclosure of patient
records for purposes other than criminal investigation or prosecution
may be applied for by any person having a legally recognized interest in
the disclosure which is sought. The application may be filed separately
or as part of a pending civil action in which it appears that the
patient records are needed to provide evidence. An application must use
a fictitious name, such as John Doe, to refer to any patient and may not
contain or otherwise disclose any patient identifying information unless
the patient is the applicant or has given a written consent (meeting the
requirements of these regulations) to disclosure or the court has
ordered the record of the proceeding sealed from public scrunity.
(b) Notice. The patient and the person holding the records from whom
disclosure is sought must be given:
(1) Adequate notice in a manner which will not disclose patient
identifying information to other persons; and
(2) An opportunity to file a written response to the application, or
to appear in person, for the limited purpose of providing evidence on
the statutory and regulatory criteria for the issuance of the court
order.
(c) Review of evidence: Conduct of hearing. Any oral argument,
review of evidence, or hearing on the application must be held in the
judge's chambers or in some manner which ensures that patient
identifying information is not disclosed to anyone other than a party to
the proceeding, the patient, or the person holding the record, unless
the patient requests an open hearing in a
[[Page 24]]
manner which meets the written consent requirements of these
regulations. The proceeding may include an examination by the judge of
the patient records referred to in the application.
(d) Criteria for entry of order. An order under this section may be
entered only if the court determines that good cause exists. To make
this determination the court must find that:
(1) Other ways of obtaining the information are not available or
would not be effective; and
(2) The public interest and need for the disclosure outweigh the
potential injury to the patient, the physician-patient relationship and
the treatment services.
(e) Content of order. An order authorizing a disclosure must:
(1) Limit disclosure to those parts of the patient's record which
are essential to fulfill the objective of the order;
(2) Limit disclosure to those persons whose need for information is
the basis for the order; and
(3) Include such other measures as are necessary to limit disclosure
for the protection of the patient, the physician-patient relationship
and the treatment services; for example, sealing from public scrutiny
the record of any proceeding for which disclosure of a patient's record
has been ordered.
Sec. 2.65 Procedures and criteria for orders authorizing disclosure
and use of records to criminally investigate or prosecute patients.
(a) Application. An order authorizing the disclosure or use of
patient records to criminally investigate or prosecute a patient may be
applied for by the person holding the records or by any person
conducting investigative or prosecutorial activities with respect to the
enforcement of criminal laws. The application may be filed separately,
as part of an application for a subpoena or other compulsory process, or
in a pending criminal action. An application must use a fictitious name
such as John Doe, to refer to any patient and may not contain or
otherwise disclose patient identifying information unless the court has
ordered the record of the proceeding sealed from public scrutiny.
(b) Notice and hearing. Unless an order under Sec. 2.66 is sought
with an order under this section, the person holding the records must be
given:
(1) Adequate notice (in a manner which will not disclose patient
identifying information to third parties) of an application by a person
performing a law enforcement function;
(2) An opportunity to appear and be heard for the limited purpose of
providing evidence on the statutory and regulatory criteria for the
issuance of the court order; and
(3) An opportunity to be represented by counsel independent of
counsel for an applicant who is a person performing a law enforcement
function.
(c) Review of evidence: Conduct of hearings. Any oral argument,
review of evidence, or hearing on the application shall be held in the
judge's chambers or in some other manner which ensures that patient
identifying information is not disclosed to anyone other than a party to
the proceedings, the patient, or the person holding the records. The
proceeding may include an examination by the judge of the patient
records referred to in the application.
(d) Criteria. A court may authorize the disclosure and use of
patient records for the purpose of conducting a criminal investigation
or prosecution of a patient only if the court finds that all of the
following criteria are met:
(1) The crime involved is extremely serious, such as one which
causes or directly threatens loss of life or serious bodily injury
including homicide, rape, kidnapping, armed robbery, assault with a
deadly weapon, and child abuse and neglect.
(2) There is a reasonable likelihood that the records will disclose
information of substantial value in the investigation or prosecution.
(3) Other ways of obtaining the information are not available or
would not be effective.
(4) The potential injury to the patient, to the physician-patient
relationship and to the ability of the program to provide services to
other patients is outweighed by the public interest and the need for the
disclosure.
(5) If the applicant is a person performing a law enforcement
function that:
(i) The person holding the records has been afforded the opportunity
to be
[[Page 25]]
represented by independent counsel; and
(ii) Any person holding the records which is an entity within
Federal, State, or local government has in fact been represented by
counsel independent of the applicant.
(e) Content of order. Any order authorizing a disclosure or use of
patient records under this section must:
(1) Limit disclosure and use to those parts of the patient's record
which are essential to fulfill the objective of the order;
(2) Limit disclosure to those law enforcement and prosecutorial
officials who are responsible for, or are conducting, the investigation
or prosecution, and limit their use of the records to investigation and
prosecution of extremely serious crime or suspected crime specified in
the application; and
(3) Include such other measures as are necessary to limit disclosure
and use to the fulfillment of only that public interest and need found
by the court.
[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]
Sec. 2.66 Procedures and criteria for orders authorizing disclosure
and use of records to investigate or prosecute a program or the person
holding the records.
(a) Application. (1) An order authorizing the disclosure or use of
patient records to criminally or administratively investigate or
prosecute a program or the person holding the records (or employees or
agents of that program or person) may be applied for by any
administrative, regulatory, supervisory, investigative, law enforcement,
or prosecutorial agency having jurisdiction over the program's or
person's activities.
(2) The application may be filed separately or as part of a pending
civil or criminal action against a program or the person holding the
records (or agents or employees of the program or person) in which it
appears that the patient records are needed to provide material
evidence. The application must use a fictitious name, such as John Doe,
to refer to any patient and may not contain or otherwise disclose any
patient identifying information unless the court has ordered the record
of the proceeding sealed from public scrutiny or the patient has given a
written consent (meeting the requirements of Sec. 2.31 of these
regulations) to that disclosure.
(b) Notice not required. An application under this section may, in
the discretion of the court, be granted without notice. Although no
express notice is required to the program, to the person holding the
records, or to any patient whose records are to be disclosed, upon
implementation of an order so granted any of the above persons must be
afforded an opportunity to seek revocation or amendment of that order,
limited to the presentation of evidence on the statutory and regulatory
criteria for the issuance of the court order.
(c) Requirements for order. An order under this section must be
entered in accordance with, and comply with the requirements of,
paragraphs (d) and (e) of Sec. 2.64 of these regulations.
(d) Limitations on disclosure and use of patient identifying
information: (1) An order entered under this section must require the
deletion of patient identifying information from any documents made
available to the public.
(2) No information obtained under this section may be used to
conduct any investigation or prosecution of a patient, or be used as the
basis for an application for an order under Sec. 2.65 of these
regulations.
Sec. 2.67 Orders authorizing the use of undercover agents and
informants to criminally investigate employees or agents of a program.
(a) Application. A court order authorizing the placement of an
undercover agent or informant in a program as an employee or patient may
be applied for by any law enforcement or prosecutorial agency which has
reason to believe that employees or agents of the program are engaged in
criminal misconduct.
(b) Notice. The program director must be given adequate notice of
the application and an opportunity to appear and be heard (for the
limited purpose of providing evidence on the statutory and regulatory
criteria for the issuance of the court order), unless the application
asserts a belief that:
[[Page 26]]
(1) The program director is involved in the criminal activities to
be investigated by the undercover agent or informant; or
(2) The program director will intentionally or unintentionally
disclose the proposed placement of an undercover agent or informant to
the employees or agents who are suspected of criminal activities.
(c) Criteria. An order under this section may be entered only if the
court determines that good cause exists. To make this determination the
court must find:
(1) There is reason to believe that an employee or agent of the
program is engaged in criminal activity;
(2) Other ways of obtaining evidence of this criminal activity are
not available or would not be effective; and
(3) The public interest and need for the placement of an undercover
agent or informant in the program outweigh the potential injury to
patients of the program, physician-patient relationships and the
treatment services.
(d) Content of order. An order authorizing the placement of an
undercover agent or informant in a program must:
(1) Specifically authorize the placement of an undercover agent or
an informant;
(2) Limit the total period of the placement to six months;
(3) Prohibit the undercover agent or informant from disclosing any
patient identifying information obtained from the placement except as
necessary to criminally investigate or prosecute employees or agents of
the program; and
(4) Include any other measures which are appropriate to limit any
potential disruption of the program by the placement and any potential
for a real or apparent breach of patient confidentiality; for example,
sealing from public scrutiny the record of any proceeding for which
disclosure of a patient's record has been ordered.
(e) Limitation on use of information. No information obtained by an
undercover agent or informant placed under this section may be used to
criminally investigate or prosecute any patient or as the basis for an
application for an order under Sec. 2.65 of these regulations.
PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents
Sec.
2a.1 Applicability.
2a.2 Definitions.
2a.3 Application; coordination.
2a.4 Contents of application; in general.
2a.5 Contents of application; research projects in which drugs will be
administered.
2a.6 Issuance of Confidentiality Certificates; single project
limitation.
2a.7 Effect of Confidentiality Certificate.
2a.8 Termination.
Authority: Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub.
L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat.
132.
Source: 44 FR 20384, Apr. 4, 1979, unless otherwise noted.
Sec. 2a.1 Applicability.
(a) Section 303(a) of the Public Health Service Act (42 U.S.C.
242a(a)) provides that ``[t]he Secretary [of Health and Human Services]
may authorize persons engaged in 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.'' The regulations in this part establish procedures
under which any person engaged in research on mental health including
research on the use and effect of alcohol and other psychoactive drugs
(whether or not the research is federally funded) may, subject to the
exceptions set forth in paragraph (b) of this section, apply for such an
authorization of confidentiality.
(b) These regulations do not apply to:
(1) Authorizations of confidentiality for research requiring an
Investigational New Drug exemption under section 505(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new
drugs, such as methadone, requiring continuation of long-
[[Page 27]]
term studies, records, and reports. Attention is called to 21 CFR
291.505(g) relating to authorizations of confidentiality for patient
records maintained by methadone treatment programs.
(2) Authorizations of confidentiality for research which are related
to law enforcement activities or otherwise within the purview of the
Attorney General's authority to issue authorizations of confidentiality
pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C.
872(c)) and 21 CFR 1316.21.
(c) The Secretary's regulations on confidentiality of alcohol and
drug abuse patient records (42 CFR part 2) and the regulations of this
part may, in some instances, concurrently cover the same transaction. As
explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary
disclosures of information from applicable patient records while a
Confidentiality Certificate issued pursuant to the regulations of this
part protects a person engaged in applicable research from being
compelled to disclose identifying characteristics of individuals who are
the subject of such research.
Sec. 2a.2 Definitions.
(a) Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
(b) Person means any individual, corporation, government, or
governmental subdivision or agency, business trust, partnership,
association, or other legal entity.
(c) Research means systematic study directed toward new or fuller
knowledge and understanding of the subject studied. The term includes,
but is not limited to, behavioral science studies, surveys, evaluations,
and clinical investigations.
(d) Drug has the meaning given that term by section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
(e) Controlled drug means a drug which is included in schedule I,
II, III, IV, or V of part B of the Controlled Substances Act (21 U.S.C.
811-812).
(f) Administer refers to the direct application of a drug to the
body of a human research subject, whether such application be by
injection, inhalation, ingestion, or any other means, by (1) a qualified
person engaged in research (or, in his or her presence, by his or her
authorized agent), or (2) a research subject in accordance with
instructions of a qualified person engaged in research, whether or not
in the presence of a qualified person engaged in research.
(g) Identifying characteristics refers to the name, address, any
identifying number, fingerprints, voiceprints, photographs or any other
item or combination of data about a research subject which could
reasonably lead directly or indirectly by reference to other information
to identification of that research subject.
(h) Psychoactive drug means, in addition to alcohol, any drug which
has as its principal action an effect on thought, mood, or behavior.
Sec. 2a.3 Application; coordination.
(a) Any person engaged in (or who intends to engage in) the research
to which this part applies, who desires authorization to withhold the
names and other identifying characteristics of individuals who are the
subject of such research from any person or authority not connected with
the conduct of such research may apply to the Office of the Director,
National Institute on Drug Abuse, the Office of the Director, National
Institute of Mental Health, or the Office of the Director, National
Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville,
Maryland 20857 for an authorization of confidentiality.
(b) If there is uncertainty with regard to which Institute is
appropriate or if the research project falls within the purview of more
than one Institute, an application need be submitted only to one
Institute. Persons who are uncertain with regard to the applicability of
these regulations to a particular type of research may apply for an
authorization of confidentiality under the regulations of this part to
one of the Institutes. Requests which are within the scope of the
authorities described
[[Page 28]]
in Sec. 2a.1(b) will be forwarded to the appropriate agency for
consideration and the person will be advised accordingly.
(c) An application may accompany, precede, or follow the sumission
of a request for DHHS grant or contract assistance, though it is not
necessary to request DHHS grant or contract assistance in order to apply
for a Confidentiality Certificate. If a person has previously submitted
any information required in this part in connection with a DHHS grant or
contract, he or she may substitute a copy of information thus submitted,
if the information is current and accurate. If a person requests a
Confidentiality Certificate at the same time he or she submits an
application for DHHS grant or contract assistance, the application for a
Confidentiality Certificate may refer to the pertinent section(s) of the
DHHS grant or contract application which provide(s) the information
required to be submitted under this part. (See Sec. Sec. 2a.4 and
2a.5.)
(d) A separate application is required for each research project for
which an authorization of confidentiality is requested.
Sec. 2a.4 Contents of application; in general.
In addition to any other pertinent information which the Secretary
may require, each application for an authorization of confidentiality
for a research project shall contain:
(a) The name and address of the individual primarily responsible for
the conduct of the research and the sponsor or institution with which he
or she is affiliated, if any. Any application from a person affiliated
with an institution will be considered only if it contains or is
accompanied by documentation of institutional approval. This
documentation may consist of a written statement signed by a responsible
official of the institution or of a copy of or reference to a valid
certification submitted in accordance with 45 CFR part 46.
(b) The location of the research project and a description of the
facilities available for conducting the research, including the name and
address of any hospital, institution, or clinical laboratory facility to
be utilized in connection with the research.
(c) The names, addresses, and summaries of the scientific or other
appropriate training and experience of all personnel having major
responsibilities in the research project and the training and experience
requirements for major positions not yet filled.
(d) An outline of the research protocol for the project including a
clear and concise statement of the purpose and rationale of the research
project and the general research methods to be used.
(e) The date on which research will begin or has begun and the
estimated date for completion of the project.
(f) A specific request, signed by the individual primarily
responsible for the conduct of the research, for authority to withhold
the names and other identifying characteristics of the research subjects
and the reasons supporting such request.
(g) An assurance (1) From persons making application for a
Confidentiality Certificate for a research project for which DHHS grant
or contract support is received or sought that they will comply with all
the requirements of 45 CFR part 46, ``Protection of Human Subjects,'' or
(2) From all other persons making application that they will comply
with the informed consent requirements of 45 CFR 46.103(c) and document
legally effective informed consent in a manner consistent with the
principles stated in 45 CFR 46.110, if it is determined by the
Secretary, on the basis of information submitted by the person making
application, that subjects will be placed at risk. If a modification of
paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under
paragraph (c) of that section, the applicant will describe the proposed
modification and submit it for approval by the Secretary.
(h) An assurance that if an authorization of confidentiality is
given it will not be represented as an endorsement of the research
project by the Secretary or used to coerce individuals to participate in
the research project.
(i) An assurance that any person who is authorized by the Secretary
to protect the privacy of research subjects
[[Page 29]]
will use that authority to refuse to disclose identifying
characteristics of research subjects in any Federal, State, or local
civil, criminal, administrative, legislative, or other proceedings to
compel disclosure of the identifying characteristics of research
subjects.
(j) An assurance that all research subjects who participate in the
project during the period the Confidentiality Certificate is in effect
will be informed that:
(1) A Confidentiality Certificate has been issued;
(2) The persons authorized by the Confidentiality Certificate to
protect the identity of research subjects may not be compelled to
identify research subjects in any civil, criminal, administrative,
legislative, or other proceedings whether Federal, State, or local;
(3) If any of the following conditions exist the Confidentiality
Certificate does not authorize any person to which it applies to refuse
to reveal identifying information concerning research subjects:
(i) The subject consents in writing to disclosure of identifying
information,
(ii) Release is required by the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of
Federal Regulations), or
(iii) Authorized personnel of DHHS request identifying information
for audit or program evaluation of a research project funded by DHHS or
for investigation of DHHS grantees or contractors and their employees or
agents carrying out such a project. (See Sec. 2a.7(b));
(4) The Confidentiality Certificate does not govern the voluntary
disclosure of identifying characteristics of research subjects;
(5) The Confidentiality Certificate does not represent an
endorsement of the research project by the Secretary.
(k) An assurance that all research subjects who enter the project
after the termination of the Confidentiality Certificate will be
informed that the authorization of confidentiality has ended and that
the persons authorized to protect the identity of research subjects by
the Confidentiality Certificate may not rely on the Certificate to
refuse to disclose identifying characteristics of research subjects who
were not participants in the project during the period the Certificate
was in effect. (See Sec. 2a.8(c)).
Sec. 2a.5 Contents of application; research projects in which drugs
will be administered.
(a) In addition to the information required by Sec. 2a.4 and any
other pertinent information which the Secretary may require, each
application for an authorization of confidentiality for a research
project which involves the administering of a drug shall contain:
(1) Identification of the drugs to be administered in the research
project and a description of the methods for such administration, which
shall include a statement of the dosages to be administered to the
research subjects;
(2) Evidence that individuals who administer drugs are authorized to
do so under applicable Federal and State law; and
(3) In the case of a controlled drug, a copy of the Drug Enforcement
Administration Certificate of Registration (BND Form 223) under which
the research project will be conducted.
(b) An application for an authorization of confidentiality with
respect to a research project which involves the administering of a
controlled drug may include a request for exemption of persons engaged
in the research from State or Federal prosecution for possession,
distribution, and dispensing of controlled drugs as authorized under
section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and
21 CFR 1316.22. If the request is in such form, and is supported by such
information, as is required by 21 CFR 1316.22, the Secretary will
forward it, together with his or her recommendation that such request be
approved or disapproved, for the consideration of the Administrator of
the Drug Enforcement Administration.
Sec. 2a.6 Issuance of Confidentiality Certificates; single project
limitation.
(a) In reviewing the information provided in the application for a
Confidentiality Certificate, the Secretary will take into account:
[[Page 30]]
(1) The scientific or other appropriate training and experience of
all personnel having major responsibilities in the research project;
(2) Whether the project constitutes bona fide ``research'' which is
within the scope of the regulations of this part; and
(3) Such other factors as he or she may consider necessary and
appropriate. All applications for Confidentiality Certificates shall be
evaluated by the Secretary through such officers and employees of the
Department and such experts or consultants engaged for this purpose as
he or she determines to be appropriate.
(b) After consideration and evaluation of an application for an
authorization of confidentiality, the Secretary will either issue a
Confidentiality Certificate or a letter denying a Confidentiality
Certificate, which will set forth the reasons for such denial, or will
request additional information from the person making application. The
Confidentiality Certificate will include:
(1) The name and address of the person making application;
(2) The name and address of the individual primarily responsible for
conducting the research, if such individual is not the person making
application;
(3) The location of the research project;
(4) A brief description of the research project;
(5) A statement that the Certificate does not represent an
endorsement of the research project by the Secretary;
(6) The Drug Enforcement Administration registration number for the
project, if any; and
(7) The date or event upon which the Confidentiality Certificate
becomes effective, which shall not be before the later of either the
commencement of the research project or the date of issuance of the
Certificate, and the date or event upon which the Certificate will
expire.
(c) A Confidentiality Certificate is not transferable and is
effective only with respect to the names and other identifying
characteristics of those individuals who are the subjects of the single
research project specified in the Confidentiality Certificate. The
recipient of a Confidentiality Certificate shall, within 15 days of any
completion or discontinuance of the research project which occurs prior
to the expiration date set forth in the Certificate, provide written
notification to the Director of the Institute to which application was
made. If the recipient determines that the research project will not be
completed by the expiration date set forth in the Confidentiality
Certificate he or she may submit a written request for an extension of
the expiration date which shall include a justification for such
extension and a revised estimate of the date for completion of the
project. Upon approval of such a request, the Secretary will issue an
amended Confidentiality Certificate.
(d) The protection afforded by a Confidentiality Certificate does
not extend to significant changes in the research project as it is
described in the application for such Certificate (e.g., changes in the
personnel having major responsibilities in the research project, major
changes in the scope or direction of the research protocol, or changes
in the drugs to be administered and the persons who will administer
them). The recipient of a Confidentiality Certificate shall notify the
Director of the Institute to which application was made of any proposal
for such a significant change by submitting an amended application for a
Confidentiality Certificate in the same form and manner as an original
application. On the basis of such application and other pertinent
information the Secretary will either:
(1) Approve the amended application and issue an amended
Confidentiality Certificate together with a Notice of Cancellation
terminating original the Confidentiality Certificate in accordance with
Sec. 2a.8; or
(2) Disapprove the amended application and notify the applicant in
writing that adoption of the proposed significant changes will result in
the issuance of a Notice of Cancellation terminating the original
Confidentiality Certificate in accordance with Sec. 2a.8.
Sec. 2a.7 Effect of Confidentiality Certificate.
(a) A Confidentiality Certificate authorizes the withholding of the
names and other identifying characteristics of
[[Page 31]]
individuals who participate as subjects in the research project
specified in the Certificate while the Certificate is in effect. The
authorization applies to all persons who, in the performance of their
duties in connection with the research project, have access to
information which would identify the subjects of the research. Persons
so authorized may not, at any time, be compelled in any Federal, State,
or local civil, criminal, administrative, legislative, or other
proceedings to identify the research subjects encompassed by the
Certificate, except in those circumstances specified in paragraph (b) of
this section.
(b) A Confidentiality Certificate granted under this part does not
authorize any person to refuse to reveal the name or other identifying
characteristics of any research subject in the following circumstances:
(1) The subject (or, if he or she is legally incompetent, his or her
guardian) consents, in writing, to the disclosure of such information,
(2) Authorized personnel of DHHS request such information for audit
or program evaluation of a research project funded by DHHS or for
investigation of DHHS grantees or contractors and their employees or
agents carrying out such a project. (See 45 CFR 5.71 for confidentiality
standards imposed on such DHHS personnel), or
(3) Release of such information is required by the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated
thereunder (title 21, Code of Federal Regulations).
(c) Neither a Confidentiality Certificate nor the regulations of
this part govern the voluntary disclosure of identifying characteristics
of research subjects.
Sec. 2a.8 Termination.
(a) A Confidentiality Certificate is in effect from the date of its
issuance until the effective date of its termination. The effective date
of termination shall be the earlier of:
(1) The expiration date set forth in the Confidentiality
Certificate; or
(2) Ten days from the date of mailing a Notice of Cancellation to
the applicant, pursuant to a determination by the Secretary that the
research project has been completed or discontinued or that retention of
the Confidentiality Certificate is otherwise no longer necessary or
desirable.
(b) A Notice of Cancellation shall include: an identification of the
Confidentiality Certificate to which it applies; the effective date of
its termination; and the grounds for cancellation. Upon receipt of a
Notice of Cancellation the applicant shall return the Confidentiality
Certificate to the Secretary.
(c) Any termination of a Confidentiality Certificate pursuant to
this section is operative only with respect to the names and other
identifying characteristics of individuals who begin their participation
as research subjects after the effective date of such termination. (See
Sec. 2a.4(k) requiring researchers to notify subjects who enter the
project after the termination of the Confidentiality Certificate of
termination of the Certificate). The protection afforded by a
Confidentiality Certificate is permanent with respect to subjects who
participated in research during any time the authorization was in
effect.
PART 3_PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
--Table of Contents
Subpart A_General Provisions
Sec.
3.10 Purpose.
3.20 Definitions.
Subpart B_PSO Requirements and Agency Procedures
3.102 Process and requirements for initial and continued listing of
PSOs.
3.104 Secretarial actions.
3.106 Security requirements.
3.108 Correction of deficiencies, revocation, and voluntary
relinquishment.
3.110 Assessment of PSO compliance.
3.112 Submissions and forms.
Subpart C_Confidentiality and Privilege Protections of Patient Safety
Work Product
3.204 Privilege of patient safety work product.
3.206 Confidentiality of patient safety work product.
3.208 Continued protection of patient safety work product.
[[Page 32]]
3.210 Required disclosure of patient safety work product to the
Secretary.
3.212 Nonidentification of patient safety work product.
Subpart D_Enforcement Program
3.304 Principles for achieving compliance.
3.306 Complaints to the Secretary.
3.308 Compliance reviews.
3.310 Responsibilities of respondents.
3.312 Secretarial action regarding complaints and compliance reviews.
3.314 Investigational subpoenas and inquiries.
3.402 Basis for a civil money penalty.
3.404 Amount of a civil money penalty.
3.408 Factors considered in determining the amount of a civil money
penalty.
3.414 Limitations.
3.416 Authority to settle.
3.418 Exclusivity of penalty.
3.420 Notice of proposed determination.
3.422 Failure to request a hearing.
3.424 Collection of penalty.
3.426 Notification of the public and other agencies.
3.504 Hearings before an ALJ.
3.506 Rights of the parties.
3.508 Authority of the ALJ.
3.510 Ex parte contacts.
3.512 Prehearing conferences.
3.514 Authority to settle.
3.516 Discovery.
3.518 Exchange of witness lists, witness statements, and exhibits.
3.520 Subpoenas for attendance at hearing.
3.522 Fees.
3.524 Form, filing, and service of papers.
3.526 Computation of time.
3.528 Motions.
3.530 Sanctions.
3.532 Collateral estoppel.
3.534 The hearing.
3.538 Witnesses.
3.540 Evidence.
3.542 The record.
3.544 Post hearing briefs.
3.546 ALJ's decision.
3.548 Appeal of the ALJ's decision.
3.550 Stay of the Secretary's decision.
3.552 Harmless error.
Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.
Source: 73 FR 70796, Nov. 21, 2008, unless otherwise noted.
Subpart A_General Provisions
Sec. 3.10 Purpose.
The purpose of this part is to implement the Patient Safety and
Quality Improvement Act of 2005 (Pub. L. 109-41), which amended Title IX
of the Public Health Service Act (42 U.S.C. 299 et seq.) by adding
sections 921 through 926, 42 U.S.C. 299b-21 through 299b-26.
Sec. 3.20 Definitions.
As used in this part, the terms listed alphabetically below have the
meanings set forth as follows:
Affiliated provider means, with respect to a provider, a legally
separate provider that is the parent organization of the provider, is
under common ownership, management, or control with the provider, or is
owned, managed, or controlled by the provider.
AHRQ stands for the Agency for Healthcare Research and Quality in
HHS.
ALJ stands for an Administrative Law Judge of HHS.
Board means the members of the HHS Departmental Appeals Board, in
the Office of the Secretary, which issues decisions in panels of three.
Bona fide contract means:
(1) A written contract between a provider and a PSO that is executed
in good faith by officials authorized to execute such contract; or
(2) A written agreement (such as a memorandum of understanding or
equivalent recording of mutual commitments) between a Federal, State,
local, or Tribal provider and a Federal, State, local, or Tribal PSO
that is executed in good faith by officials authorized to execute such
agreement.
Complainant means a person who files a complaint with the Secretary
pursuant to Sec. 3.306.
Component organization means an entity that:
(1) Is a unit or division of a legal entity (including a
corporation, partnership, or a Federal, State, local or Tribal agency or
organization); or
(2) Is owned, managed, or controlled by one or more legally separate
parent organizations.
Component PSO means a PSO listed by the Secretary that is a
component organization.
Confidentiality provisions means for purposes of subparts C and D,
any requirement or prohibition concerning confidentiality established by
sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service
Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the
[[Page 33]]
provisions, at Sec. Sec. 3.206 and 3.208, that implement the statutory
prohibition on disclosure of identifiable patient safety work product.
Disclosure means the release, transfer, provision of access to, or
divulging in any other manner of patient safety work product by:
(1) An entity or natural person holding the patient safety work
product to another legally separate entity or natural person, other than
a workforce member of, or a health care provider holding privileges
with, the entity holding the patient safety work product; or
(2) A component PSO to another entity or natural person outside the
component PSO and within the legal entity of which the component PSO is
a part.
Entity means any organization or organizational unit, regardless of
whether the organization is public, private, for-profit, or not-for-
profit.
Group health plan means an employee welfare benefit plan (as defined
in section 3(1) of the Employee Retirement Income Security Act of 1974
(ERISA)) to the extent that the plan provides medical care (as defined
in paragraph (2) of section 2791(a) of the Public Health Service Act,
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.
Health insurance issuer means an insurance company, insurance
service, or insurance organization (including a health maintenance
organization, as defined in 42 U.S.C. 300gg-91(b)(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 29 U.S.C.
1144(b)(2)). This term does not include a group health plan.
Health maintenance organization means:
(1) A Federally qualified health maintenance organization (HMO) (as
defined in 42 U.S.C. 300e(a));
(2) An organization recognized under State law as a health
maintenance organization; or
(3) A similar organization regulated under State law for solvency in
the same manner and to the same extent as such a health maintenance
organization.
HHS stands for the United States Department of Health and Human
Services.
HIPAA Privacy Rule means the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability Act of
1996 (HIPAA), at 45 CFR part 160 and subparts A and E of part 164.
Identifiable patient safety work product means patient safety work
product that:
(1) 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, or are responsible for, activities that are a
subject of the work product;
(2) Constitutes individually identifiable health information as that
term is defined in the HIPAA Privacy Rule at 45 CFR 160.103; or
(3) Is presented in a form and manner that allows the identification
of an individual who in good faith reported information directly to a
PSO or to a provider with the intention of having the information
reported to a PSO (``reporter'').
Nonidentifiable patient safety work product means patient safety
work product that is not identifiable patient safety work product in
accordance with the nonidentification standards set forth at Sec.
3.212.
OCR stands for the Office for Civil Rights in HHS.
Parent organization means an organization that: owns a controlling
interest or a majority interest in a component organization; has the
authority to control or manage agenda setting, project management, or
day-to-day operations; or the authority to review and override decisions
of a component organization. The component organization may be a
provider.
Patient Safety Act means the Patient Safety and Quality Improvement
Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public
Health Service Act (42 U.S.C. 299 et seq.) by inserting a new Part C,
sections 921 through 926, which are codified at 42 U.S.C. 299b-21
through 299b-26.
[[Page 34]]
Patient safety activities means the following activities carried out
by or on behalf of a PSO or a provider:
(1) Efforts to improve patient safety and the quality of health care
delivery;
(2) The collection and analysis of patient safety work product;
(3) The development and dissemination of information with respect to
improving patient safety, such as recommendations, protocols, or
information regarding best practices;
(4) 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;
(5) The maintenance of procedures to preserve confidentiality with
respect to patient safety work product;
(6) The provision of appropriate security measures with respect to
patient safety work product;
(7) The utilization of qualified staff; and
(8) 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.
Patient safety evaluation system means the collection, management,
or analysis of information for reporting to or by a PSO.
Patient safety organization (PSO) means a private or public entity
or component thereof that is listed as a PSO by the Secretary in
accordance with subpart B. A health insurance issuer or a component
organization of a health insurance issuer may not be a PSO. See also the
exclusions in Sec. 3.102 of this part.
Patient safety work product:
(1) Except as provided in paragraph (2) of this definition, patient
safety work product means any data, reports, records, memoranda,
analyses (such as root cause analyses), or written or oral statements
(or copies of any of this material)
(i) Which could improve patient safety, health care quality, or
health care outcomes; and
(A) Which are assembled or developed by a provider for reporting to
a PSO and are reported to a PSO, which includes information that is
documented as within a patient safety evaluation system for reporting to
a PSO, and such documentation includes the date the information entered
the patient safety evaluation system; or
(B) Are developed by a PSO for the conduct of patient safety
activities; or
(ii) Which identify or constitute the deliberations or analysis of,
or identify the fact of reporting pursuant to, a patient safety
evaluation system.
(2)(i) Patient safety work product does not include a patient's
medical record, billing and discharge information, or any other original
patient or provider information; nor does it 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 PSO shall not by reason of its reporting be
considered patient safety work product.
(ii) Patient safety work product assembled or developed by a
provider for reporting to a PSO may be removed from a patient safety
evaluation system and no longer considered patient safety work product
if:
(A) The information has not yet been reported to a PSO; and
(B) The provider documents the act and date of removal of such
information from the patient safety evaluation system.
(iii) Nothing in this part shall be construed to limit information
that is not patient safety work product from being:
(A) Discovered or admitted in a criminal, civil or administrative
proceeding;
(B) Reported to a Federal, State, local or Tribal governmental
agency for public health or health oversight purposes; or
(C) Maintained as part of a provider's recordkeeping obligation
under Federal, State, local or Tribal law.
Person means a natural person, trust or estate, partnership,
corporation, professional association or corporation, or other entity,
public or private.
Provider means:
(1) An individual or entity licensed or otherwise authorized under
State law to provide health care services, including--
[[Page 35]]
(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 (includes a group practice), long term
care facility, behavior health residential treatment facility, clinical
laboratory, or health center; or
(ii) A physician, physician assistant, registered nurse, 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;
(2) Agencies, organizations, and individuals within Federal, State,
local, or Tribal governments that deliver health care, organizations
engaged as contractors by the Federal, State, local, or Tribal
governments to deliver health care, and individual health care
practitioners employed or engaged as contractors by the Federal State,
local, or Tribal governments to deliver health care; or
(3) A parent organization of one or more entities described in
paragraph (1)(i) of this definition or a Federal, State, local, or
Tribal government unit that manages or controls one or more entities
described in paragraphs (1)(i) or (2) of this definition.
Research has the same meaning as the term is defined in the HIPAA
Privacy Rule at 45 CFR 164.501.
Respondent means a provider, PSO, or responsible person who is the
subject of a complaint or a compliance review.
Responsible person means a person, other than a provider or a PSO,
who has possession or custody of identifiable patient safety work
product and is subject to the confidentiality provisions.
Workforce means employees, volunteers, trainees, contractors, or
other persons whose conduct, in the performance of work for a provider,
PSO or responsible person, is under the direct control of such provider,
PSO or responsible person, whether or not they are paid by the provider,
PSO or responsible person.
Subpart B_PSO Requirements and Agency Procedures
Sec. 3.102 Process and requirements for initial and continued listing
of PSOs.
(a) Eligibility and process for initial and continued listing--(1)
Submission of certification. Any entity, except as specified in
paragraph (a)(2) of this section, may request from the Secretary an
initial or continued listing as a PSO by submitting a completed
certification form that meets the requirements of this section, in
accordance with Sec. 3.112. An individual with authority to make
commitments on behalf of the entity seeking listing will be required to
submit contact information for the entity and:
(i) Attest that the entity is not subject to any exclusion in
paragraph (a)(2) of this section;
(ii) Provide certifications that the entity meets each requirement
for PSOs in paragraph (b) of this section;
(iii) If the entity is a component of another organization, provide
the additional certifications that the entity meets the requirements of
paragraph (c)(1)(i) of this section;
(iv) If the entity is a component of an excluded entity described in
paragraph (a)(2)(ii), provide the additional certifications and
information required by paragraph (c)(1)(ii) of this section;
(v) Attest that the entity has disclosed if the Secretary has ever
delisted this entity (under its current name or any other) or refused to
list the entity or whether any of its officials or senior managers held
comparable positions of responsibility in an entity that was denied
listing or delisted and, if any of these circumstances apply, submit
with its certifications and related disclosures, the name of the entity
or entities that the Secretary declined to list or delisted;
(vi) Attest that the PSO will promptly notify the Secretary during
its period of listing if it can no longer comply with any of its
attestations and the applicable requirements in Sec. Sec. 3.102(b) and
3.102(c) or if there have been any changes in the accuracy of the
information submitted for listing, along with the pertinent changes; and
[[Page 36]]
(vii) Provide other information that the Secretary determines to be
necessary to make the requested listing determination.
(2) Exclusion of certain entities. The following types of entities
may not seek listing as a PSO:
(i) A health insurance issuer; a unit or division of a health
insurance issuer; or an entity that is owned, managed, or controlled by
a health insurance issuer;
(ii)(A) An entity that accredits or licenses health care providers;
(B) An entity that oversees or enforces statutory or regulatory
requirements governing the delivery of health care services;
(C) An agent of an entity that oversees or enforces statutory or
regulatory requirements governing the delivery of health care services;
or
(D) An entity that operates a Federal, state, local or Tribal
patient safety reporting system to which health care providers (other
than members of the entity's workforce or health care providers holding
privileges with the entity) are required to report information by law or
regulation.
(iii) A component of an entity listed in paragraph (a)(2)(ii) may
seek listing as a component PSO subject to the requirements and
restrictions of paragraph (c)(1)(ii) of this section.
(3) Submission of certification for continued listing. To facilitate
a timely Secretarial determination regarding acceptance of its
certification for continued listing, a PSO must submit the required
certification no later than 75 days before the expiration of a PSO's
three-year period of listing.
(b) Fifteen general PSO certification requirements. The
certifications submitted to the Secretary in accordance with paragraph
(a)(1)(ii) of this section must conform to the following 15
requirements:
(1) Required certification regarding eight patient safety
activities--(i) Initial listing. An entity seeking initial listing as a
PSO must certify that it has written policies and procedures in place to
perform each of the eight patient safety activities, defined in Sec.
3.20. With respect to paragraphs (5) and (6) in the definition of
patient safety activities regarding confidentiality and security, the
policies and procedures must include and provide for:
(A) Compliance with the confidentiality provisions of subpart C of
this part and with appropriate security measures as required by Sec.
3.106 of this subpart.
(B) Notification of each provider that submitted patient safety work
product or data as described in Sec. 3.108(b)(2) to the entity if the
submitted work product or data was subject to an unauthorized disclosure
or its security was breached.
(ii) Continued Listing. A PSO seeking continued listing must certify
that it is performing, and will continue to perform, each of the patient
safety activities defined in Sec. 3.20, and is and will continue to
comply with the requirements of paragraphs (b)(1)(i)(A) and (B) of this
section.
(2) Required certification regarding seven PSO criteria--(i) Initial
Listing. In its initial certification submission, an entity must also
certify that, if listed as a PSO, it will comply with the seven
requirements in paragraphs (b)(2)(i)(A) through (G) of this section.
(A) The mission and primary activity of the PSO must be to conduct
activities that are to improve patient safety and the quality of health
care delivery.
(B) The PSO must have appropriately qualified workforce members,
including licensed or certified medical professionals.
(C) The PSO, within the 24-month period that begins on the date of
its initial listing as a PSO, and within each sequential 24-month period
thereafter, must have 2 bona fide contracts, each of a reasonable period
of time, each with a different provider for the purpose of receiving and
reviewing patient safety work product.
(D) The PSO is not a health insurance issuer, and is not a component
of a health insurance issuer.
(E) The PSO must make disclosures to the Secretary as required under
Sec. 3.102(d), in accordance with Sec. 3.112 of this subpart.
(F) To the extent practical and appropriate, the PSO must collect
patient safety work product from providers in a standardized manner that
permits valid comparisons of similar cases among similar providers.
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(G) The PSO must utilize patient safety work product for the purpose
of providing direct feedback and assistance to providers to effectively
minimize patient risk.
(ii) Continued Listing. A PSO seeking continued listing must certify
that it is complying with, and will continue to comply with, the
requirements of paragraphs (b)(2)(i)(A) through (G) of this section.
(iii) Compliance with the criterion for collecting patient safety
work product in a standardized manner to the extent practical and
appropriate. With respect to paragraph (b)(2)(i)(F) of this section, the
Secretary will assess compliance by a PSO in the following manner.
(A) A PSO seeking continued listing must:
(1) Certify that the PSO is using the Secretary's published guidance
for common formats and definitions in its collection of patient safety
work product (option (I));
(2) Certify that the PSO is using an alternative system of formats
and definitions that permits valid comparisons of similar cases among
similar providers (option (II)); or
(3) Provide a clear explanation for why it is not practical or
appropriate for the PSO to comply with options (I) or (II) at this time.
(B) The Secretary will consider a PSO to be in compliance if the
entity complies with option (I), satisfactorily demonstrates that option
(II) permits valid comparisons of similar cases among similar providers,
or satisfactorily demonstrates that it is not practical or appropriate
for the PSO to comply with options (I) or (II) at this time.
(c) Additional certifications required of component organizations--
(1) Requirements when seeking listing--(i) Requirements that all
component organizations must meet. In addition to meeting the 15 general
PSO certification requirements of paragraph (b) of this section, an
entity seeking initial listing that is a component of another
organization must certify that it will comply with the requirements of
paragraph (c)(2) of this section. A component PSO seeking continued
listing must certify that it is complying with, and will continue to
comply with, the requirements of this same paragraph (c)(2). At initial
and continued listing, a component entity must attach to its
certifications for listing contact information for its parent
organization(s).
(ii) Additional requirements and limitations applicable to
components of entities that are excluded from listing. In addition to
the requirements under paragraph (c)(1)(i) of this section, a component
of an organization excluded from listing under paragraph (a)(2)(ii) of
this section must submit the additional certifications and specified
information for initial and continued listing and comply with paragraph
(c)(4) of this section.
(2) Required component certifications--(i) Separation of patient
safety work product. A component PSO must maintain patient safety work
product separately from the rest of the parent organization(s) of which
it is a part, and establish appropriate security measures to maintain
the confidentiality of patient safety work product. The information
system in which the component PSO maintains patient safety work product
must not permit unauthorized access by one or more individuals in, or by
units of, the rest of the parent organization(s) of which it is a part.
(ii) Nondisclosure of patient safety work product. A component PSO
must require that members of its workforce and any other contractor
staff not make unauthorized disclosures of patient safety work product
to the rest of the parent organization(s) of which it is a part.
(iii) No conflict of interest. The pursuit of the mission of a
component PSO must not create a conflict of interest with the rest of
the parent organization(s) of which it is a part.
(3) Written agreements for assisting a component PSO in the conduct
of patient safety activities. Notwithstanding the requirements of
paragraph (c)(2) of this section, a component PSO may provide access to
identifiable patient safety work product to one or more individuals in,
or to one or more units of, the rest of the parent organization(s) of
which it is a part, if the component PSO enters into a written agreement
with such individuals or units which requires that:
[[Page 38]]
(i) The component PSO will only provide access to identifiable
patient safety work product to enable such individuals or units to
assist the component PSO in its conduct of patient safety activities,
and
(ii) Such individuals or units that receive access to identifiable
patient safety work product pursuant to such written agreement will only
use or disclose such information as specified by the component PSO to
assist the component PSO in its conduct of patient safety activities,
will take appropriate security measures to prevent unauthorized
disclosures and will comply with the other certifications the component
has made pursuant to paragraph (c)(2) of this section regarding
unauthorized disclosures and conducting the mission of the PSO without
creating conflicts of interest.
(4) Required attestations, information and operational limitations
for components of entities excluded from listing. A component
organization of an entity that is subject to the restrictions of
paragraph (a)(2)(ii) of this section must:
(i) Submit the following information with its certifications for
listing:
(A) A statement describing its parent organization's role, and the
scope of the parent organization's authority, with respect to any of the
following that apply: Accreditation or licensure of health care
providers, oversight or enforcement of statutory or regulatory
requirements governing the delivery of health care services, serving as
an agent of such a regulatory oversight or enforcement authority, or
administering a public mandatory patient safety reporting system;
(B) An attestation that the parent organization has no policies or
procedures that would require or induce providers to report patient
safety work product to their component organization once listed as a PSO
and that the component PSO will notify the Secretary within 5 calendar
days of the date on which the component organization has knowledge of
the adoption by the parent organization of such policies or procedures,
and an acknowledgment that the adoption of such policies or procedures
by the parent organization during the component PSO's period of listing
will result in the Secretary initiating an expedited revocation process
in accordance with Sec. 3.108(e); and
(C) An attestation that the component organization will prominently
post notification on its Web site and publish in any promotional
materials for dissemination to providers, a summary of the information
that is required by paragraph (c)(4)(i)(A) of this section.
(ii) Comply with the following requirements during its period of
listing:
(A) The component organization may not share staff with its parent
organization(s).
(B) The component organization may enter into a written agreement
pursuant to paragraph (c)(3) but such agreements are limited to units or
individuals of the parent organization(s) whose responsibilities do not
involve the activities specified in the restrictions in paragraph
(a)(2)(ii) of this section.
(d) Required notifications. Upon listing, PSOs must meet the
following notification requirements:
(1) Notification regarding PSO compliance with the minimum contract
requirement. No later than 45 calendar days prior to the last day of the
pertinent 24-month assessment period, specified in paragraph
(b)(2)(iii)(C) of this section, the Secretary must receive from a PSO a
certification that states whether it has met the requirement of that
paragraph regarding two bona fide contracts, submitted in accordance
with Sec. 3.112 of this subpart.
(2) Notification regarding a PSO's relationships with its
contracting providers--(i) Requirement. A PSO must file a disclosure
statement regarding a provider with which it has a contract that
provides the confidentiality and privilege protections of the Patient
Safety Act (hereinafter referred to as a Patient Safety Act contract) if
the PSO has any other relationships with this provider that are
described in paragraphs (d)(2)(i)(A) through (D) of this section. The
PSO must disclose all such relationships. A disclosure statement is not
required if all of its other relationships with the provider are limited
to Patient Safety Act contracts.
(A) The provider and PSO have current contractual relationships,
other
[[Page 39]]
than those arising from any Patient Safety Act contracts, including
formal contracts or agreements that impose obligations on the PSO.
(B) The provider and PSO have current financial relationships other
than those arising from any Patient Safety Act contracts. A financial
relationship may include any direct or indirect ownership or investment
relationship between the PSO and the contracting provider, shared or
common financial interests or direct or indirect compensation
arrangements whether in cash or in-kind.
(C) The PSO and provider have current reporting relationships other
than those arising from any Patient Safety Act contracts, by which the
provider has access to information regarding the work and operation of
the PSO that is not available to other contracting providers.
(D) Taking into account all relationships that the PSO has with the
provider, the PSO is not independently managed or controlled, or the PSO
does not operate independently from, the contracting provider.
(ii) Content. A PSO must submit to the Secretary the required
attestation form for disclosures with the information specified below in
accordance with Sec. 3.112 and this section. The substantive
information that must be included with each submission has two required
parts:
(A) The Required Disclosures. The first part of the substantive
information must provide a succinct list of obligations between the PSO
and the contracting provider apart from their Patient Safety Act
contract(s) that create, or contain, any of the types of relationships
that must be disclosed based upon the requirements of paragraphs
(d)(2)(i)(A) through (D) of this section. Each reportable obligation or
discrete set of obligations that the PSO has with this contracting
provider should be listed only once; noting the specific aspects of the
obligation(s) that reflect contractual or financial relationships,
involve access to information that is not available to other providers,
or affect the independence of PSO operations, management, or control.
(B) An Explanatory Narrative. The second required part of the
substantive information must provide a brief explanatory narrative
succinctly describing: The policies and procedures that the PSO has in
place to ensure adherence to objectivity and professionally recognized
analytic standards in the assessments it undertakes; and any other
policies or procedures, or agreements with this provider, that the PSO
has in place to ensure that it can fairly and accurately perform patient
safety activities.
(iii) Deadlines for submission. The Secretary must receive a
disclosure statement within 45 days of the date on which a PSO enters a
contract with a provider if the circumstances described in any of the
paragraphs (d)(2)(i)(A) through (D) of this section are met on the date
the contract is entered. During the contract period, if these
circumstances subsequently arise, the Secretary must receive a
disclosure statement from the PSO within 45 days of the date that any
disclosure requirement in paragraph (d)(2)(i) of this section first
applies.
Sec. 3.104 Secretarial actions.
(a) Actions in response to certification submissions for initial and
continued listing as a PSO. (1) In response to an initial or continued
certification submission by an entity, pursuant to the requirements of
Sec. 3.102 of this subpart, the Secretary may--
(i) Accept the certification submission and list the entity as a
PSO, or maintain the listing of a PSO, if the Secretary determines that
the entity meets the applicable requirements of the Patient Safety Act
and this subpart;
(ii) Deny acceptance of a certification submission and, in the case
of a currently listed PSO, remove the entity from the list if the entity
does not meet the applicable requirements of the Patient Safety Act and
this subpart; or
(iii) Condition the listing of an entity or the continued listing of
a PSO, following a determination made pursuant to paragraph (c) of this
section or a determination after review of the pertinent history of an
entity that has been
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delisted or refused listing and its officials and senior managers.
(2) Basis for determination. In making a determination regarding
listing, the Secretary will consider the certification submission; any
prior actions by the Secretary regarding the entity or PSO including
delisting; any history of or current non-compliance by the entity or the
PSO or its officials or senior managers with statutory or regulatory
requirements or requests from the Secretary; the relationships of the
entity or PSO with providers; and any findings made by the Secretary in
accordance with paragraph (c) of this section.
(3) Notification. The Secretary will notify in writing each entity
of action taken on its certification submission for initial or continued
listing. The Secretary will provide reasons when an entity's
certification is conditionally accepted and the entity is conditionally
listed, when an entity's certification is not accepted and the entity is
not listed, or when acceptance of its certification is revoked and the
entity is delisted.
(b) Actions regarding PSO compliance with the minimum contract
requirement. After the date on which the Secretary, under Sec.
3.102(d)(1) of this subpart, must receive notification regarding
compliance of a PSO with the minimum contract requirement--
(1) If the PSO has met the minimum contract requirement, the
Secretary will acknowledge in writing receipt of the notification and
add information to the list established pursuant to paragraph (d) of
this section stating that the PSO has certified that it has met the
requirement.
(2) If the PSO states that it has not yet met the minimum contract
requirement by the date specified in Sec. 3.102(d)(1), or if notice is
not received by that date, the Secretary will issue to the PSO a notice
of a preliminary finding of deficiency as specified in Sec. 3.108(a)(2)
and establish a period for correction that extends until midnight of the
last day of the PSO's applicable 24-month period of assessment.
Thereafter, if the requirement has not been met, the Secretary will
provide the PSO a written notice of proposed revocation and delisting in
accordance with Sec. 3.108(a)(3).
(c) Actions regarding required disclosures by PSOs of relationships
with contracting providers. The Secretary will review and make findings
regarding each disclosure statement submitted by a PSO, pursuant to
Sec. 3.102(d)(2), regarding its relationships with contracting
provider(s), determine whether such findings warrant action regarding
the listing of the PSO in accordance with paragraph (c)(2) of this
section, and make the findings public.
(1) Basis of findings regarding PSO disclosure statements. In
reviewing disclosure statements, submitted pursuant to Sec. 3.102(d)(2)
of this subpart, the Secretary will consider the disclosed
relationship(s) between the PSO and the contracting provider and the
statements and material submitted by the PSO describing the policies and
procedures that the PSO has in place to determine whether the PSO can
fairly and accurately perform the required patient safety activities.
(2) Determination by the Secretary. Based on the Secretary's review
and findings, he may choose to take any of the following actions:
(i) For an entity seeking an initial or continued listing, the
Secretary may list or continue the listing of an entity without
conditions, list the entity subject to conditions, or deny the entity's
certification for initial or continued listing; or
(ii) For a listed PSO, the Secretary may determine that the entity
will remain listed without conditions, continue the entity's listing
subject to conditions, or remove the entity from the list of PSOs.
(3) Release of disclosure statements and Secretarial findings. (i)
Subject to paragraph (c)(3)(ii) of this section, the Secretary will make
disclosure statements available to the public along with related
findings that are made available in accordance with paragraph (c) of
this section.
(ii) The Secretary may withhold information that is exempt from
public disclosure under the Freedom of Information Act, e.g., trade
secrets or confidential commercial information that are subject to the
restrictions of 18 U.S.C. 1905.
(d) Maintaining a list of PSOs. The Secretary will compile and
maintain a
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publicly available list of entities whose certifications as PSOs have
been accepted. The list will include contact information for each
entity, a copy of all certification forms and disclosure statements
submitted by each entity in accordance with paragraph (c)(3)(ii) of this
section, the effective date of the PSO's listing, and information on
whether a PSO has certified that it has met the two contract
requirement. The list also will include a copy of the Secretary's
findings regarding each disclosure statement submitted by an entity,
information describing any related conditions that have been placed by
the Secretary on the listing of an entity as a PSO, and other
information that this Subpart states may be made public. AHRQ may
maintain a PSO website (or a comparable future form of public notice)
and may post the list on this website.
(e) Three-year period of listing. (1) The three-year period of
listing of a PSO will automatically expire at midnight of the last day
of this period, unless the listing had been revoked or relinquished
earlier in accordance with Sec. 3.108 of this subpart, or if, prior to
this automatic expiration, the PSO seeks a new three-year listing, in
accordance with Sec. 3.102, and the Secretary accepts the PSO's
certification for a new three-year listing, in accordance with Sec.
3.104(a).
(2) The Secretary plans to send a written notice of imminent
expiration to a PSO at least 60 calendar days prior to the date on which
its three-year period of listing expires if the Secretary has not yet
received a certification for continued listing. The Secretary plans to
indicate, on the AHRQ PSO website, the PSOs from whom certifications for
continued listing have not been timely received.
(f) Effective dates of Secretarial actions. Unless otherwise stated,
the effective date of each action by the Secretary pursuant to this
subpart will be specified in the written notice of such action that is
sent to the entity. When the Secretary sends a notice that addresses
acceptance or revocation of an entity's certifications or voluntary
relinquishment by an entity of its status as a PSO, the notice will
specify the effective date and time of listing or delisting.
Sec. 3.106 Security requirements.
(a) Application. A PSO must secure patient safety work product in
conformance with the security requirements of paragraph (b) of this
section. These requirements must be met at all times and at any location
at which the PSO, its workforce members, or its contractors receive,
access, or handle patient safety work product. Handling patient safety
work product includes its processing, development, use, maintenance,
storage, removal, disclosure, transmission and destruction.
(b) Security framework. A PSO must have written policies and
procedures that address each of the considerations specified in this
subsection. In addressing the framework that follows, the PSO may
develop appropriate and scalable security standards, policies, and
procedures that are suitable for the size and complexity of its
organization.
(1) Security management. A PSO must address:
(i) Maintenance and effective implementation of written policies and
procedures that conform to the requirements of this section to protect
the confidentiality, integrity, and availability of the patient safety
work product that is received, accessed, or handled; and to monitor and
improve the effectiveness of such policies and procedures, and
(ii) Training of the PSO workforce and PSO contractors who receive,
access, or handle patient safety work product regarding the requirements
of the Patient Safety Act, this Part, and the PSO's policies and
procedures regarding the confidentiality and security of patient safety
work product.
(2) Distinguishing patient safety work product. A PSO must address:
(i) Maintenance of the security of patient safety work product,
whether in electronic or other media, through either physical separation
from non-patient safety work product, or if co-located with non-patient
safety work product, by making patient safety work product
distinguishable so that the appropriate form and level of security can
be applied and maintained;
[[Page 42]]
(ii) Protection of the media, whether in electronic, paper, or other
media or format, that contain patient safety work product, limiting
access to authorized users, and sanitizing and destroying such media
before their disposal or release for reuse; and
(iii) Physical and environmental protection, to control and limit
physical and virtual access to places and equipment where patient safety
work product is received, accessed, or handled.
(3) Security control and monitoring. A PSO must address:
(i) Identification of those authorized to receive, access, or handle
patient safety work product and an audit capacity to detect unlawful,
unauthorized, or inappropriate receipt, access, or handling of patient
safety work product, and
(ii) Methods to prevent unauthorized receipt, access, or handling of
patient safety work product.
(4) Security assessment. A PSO must address:
(i) Periodic assessments of security risks and controls to establish
if its controls are effective, to correct any deficiency identified, and
to reduce or eliminate any vulnerabilities.
(ii) System and communications protection, to monitor, control, and
protect PSO receipt, access, or handling of patient safety work product
with particular attention to the transmission of patient safety work
product to and from providers, other PSOs, contractors or any other
responsible persons.
Sec. 3.108 Correction of deficiencies, revocation, and voluntary
relinquishment.
(a) Process for correction of a deficiency and revocation--(1)
Circumstances leading to revocation. The Secretary may revoke his
acceptance of an entity's certification (``revocation'') and delist the
entity as a PSO if he determines--
(i) The PSO is not fulfilling the certifications made to the
Secretary as required by Sec. 3.102;
(ii) The PSO has not met the two contract requirement, as required
by Sec. 3.102(d)(1);
(iii) Based on a PSO's disclosures made pursuant to Sec.
3.102(d)(2) , that the entity cannot fairly and accurately perform the
patient safety activities of a PSO with a public finding to that effect;
or
(iv) The PSO is not in compliance with any other provision of the
Patient Safety Act or this part.
(2) Notice of preliminary finding of deficiency and establishment of
an opportunity for correction of a deficiency. (i) Except as provided by
paragraph (e) of this section, if the Secretary determines that a PSO is
not in compliance with its obligations under the Patient Safety Act or
this subpart, the Secretary must send a PSO written notice of the
preliminary finding of deficiency. The notice must state the actions or
inactions that encompass the deficiency finding, outline the evidence
that the deficiency exists, specify the possible and/or required
corrective actions that must be taken, and establish a date by which the
deficiency must be corrected. The Secretary may specify in the notice
the form of documentation required to demonstrate that the deficiency
has been corrected.
(ii) The notice of a preliminary finding of deficiency is presumed
received five days after it is sent, absent evidence of the actual
receipt date. If a PSO does not submit evidence to the Secretary within
14 calendar days of actual or constructive receipt of such notice,
whichever is longer, which demonstrates that the preliminary finding is
factually incorrect, the preliminary finding will be the basis for a
finding of deficiency.
(3) Determination of correction of a deficiency. (i) Unless the
Secretary specifies another date, the Secretary must receive
documentation to demonstrate that the PSO has corrected any deficiency
cited in the preliminary finding of deficiency no later than five
calendar days following the last day of the correction period that is
specified by the Secretary in such notice.
(ii) In making a determination regarding the correction of any
deficiency, the Secretary will consider the documentation submitted by
the PSO, any assessments under Sec. 3.110, recommendations of program
staff, and any other information available regarding the PSO that the
Secretary deems appropriate and relevant to the PSO's implementation of
the terms of its certification.
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(iii) After completing his review, the Secretary may make one of the
following determinations:
(A) The action(s) taken by the PSO have corrected any deficiency, in
which case the Secretary will withdraw the notice of deficiency and so
notify the PSO;
(B) The PSO has acted in good faith to correct the deficiency, but
the Secretary finds an additional period of time is necessary to achieve
full compliance and/or the required corrective action specified in the
notice of a preliminary finding of deficiency needs to be modified in
light of the experience of the PSO in attempting to implement the
corrective action, in which case the Secretary will extend the period
for correction and/or modify the specific corrective action required; or
(C) The PSO has not completed the corrective action because it has
not acted with reasonable diligence or speed to ensure that the
corrective action was completed within the allotted time, in which case
the Secretary will issue to the PSO a notice of proposed revocation and
delisting.
(iv) When the Secretary issues a written notice of proposed
revocation and delisting, the notice will specify the deficiencies that
have not been timely corrected and will detail the manner in which the
PSO may exercise its opportunity to be heard in writing to respond to
the deficiencies specified in the notice.
(4) Opportunity to be heard in writing following a notice of
proposed revocation and delisting. The Secretary will afford a PSO an
opportunity to be heard in writing, as specified in paragraph (a)(4)(i)
of this section, to provide a substantive response to the deficiency
finding(s) set forth in the notice of proposed revocation and delisting.
(i) The notice of proposed revocation and delisting is presumed
received five days after it is sent, absent evidence of actual receipt.
The Secretary will provide a PSO with a period of time, beginning with
the date of receipt of the notice of proposed revocation and delisting
of which there is evidence, or the presumed date of receipt if there is
no evidence of earlier receipt, and ending at midnight 30 calendar days
thereafter, during which the PSO may submit a substantive response to
the deficiency findings in writing.
(ii) The Secretary will provide to the PSO any rules of procedure
governing the form or transmission of the written response to the notice
of proposed revocation and delisting. Such rules may also be posted on
the AHRQ PSO Web site or published in the Federal Register.
(iii) If a PSO does not submit a written response to the deficiency
finding(s) within 30 calendar days of receipt of the notice of proposed
revocation and delisting, the notice of proposed revocation becomes
final as a matter of law and the basis for Secretarial action under
paragraph (b)(1) of this section.
(5) The Secretary's decision regarding revocation. The Secretary
will review the entire administrative record pertaining to a notice of
proposed revocation and delisting and any written materials submitted by
the PSO under paragraph (a)(4) of this section. The Secretary may
affirm, reverse, or modify the notice of proposed revocation and
delisting and will make a determination with respect to the continued
listing of the PSO.
(b) Revocation of the Secretary's acceptance of a PSO's
certifications--(1) Establishing the date and time of revocation and
delisting. When the Secretary concludes, in accordance with a decision
made under paragraphs (a)(5), (e)(3)(iii) or (e)(3)(iv)(C) of this
section, that revocation of the acceptance of a PSO's certification is
warranted for its failure to comply with requirements of the Patient
Safety Act or of this Part, the Secretary will establish the effective
time and date for such prompt revocation and removal of the entity from
the list of PSOs, so notify the PSO in writing, and provide the relevant
public notice required by Sec. 3.108(d) of this subpart.
(2) Required notification of providers and status of data. (i) Upon
being notified of the Secretary's action pursuant to paragraph (b)(1) of
this section, the former PSO will take all reasonable actions to notify
each provider, whose patient safety work product it collected
[[Page 44]]
or analyzed, of the Secretary's action(s) and the following statutory
information: Confidentiality and privilege protections that applied to
patient safety work product while the former PSO was listed continue to
apply after the entity is removed from listing. Data submitted by
providers to the former PSO for 30 calendar days following the date and
time on which the entity was removed from the list of PSOs pursuant to
paragraph (b)(1) of this section will have the same status as data
submitted while the entity was still listed.
(ii) Within 15 days of being notified of the Secretary's action
pursuant to paragraph (b)(1) of this section, the former PSO shall
submit to the Secretary confirmation that it has taken the actions in
paragraph (b)(2)(i) of this section.
(3) Disposition of patient safety work product and data. Within 90
days following the effective date of revocation and delisting pursuant
to paragraph (b)(1) of this section, the former PSO will take one or
more of the following measures in regard to patient safety work product
and data described in paragraph (b)(2)(i) of this section:
(i) Transfer such patient safety work product or data, with the
approval of the source from which it was received, to a PSO that has
agreed to receive such patient safety work product or data;
(ii) Return such work product or data to the source from which it
was submitted; or
(iii) If returning such patient safety work product or data to its
source is not practicable, destroy such patient safety work product or
data.
(c) Voluntary relinquishment--(1) Circumstances constituting
voluntary relinquishment. A PSO will be considered to have voluntarily
relinquished its status as a PSO if the Secretary accepts a notification
from a PSO that it wishes to relinquish voluntarily its listing as a
PSO.
(2) Notification of voluntary relinquishment. A PSO's notification
of voluntary relinquishment to the Secretary must include the following:
(i) An attestation that all reasonable efforts have been made, or
will have been made by a PSO within 15 calendar days of this statement,
to notify the sources from which it received patient safety work product
of the PSO's intention to cease PSO operations and activities, to
relinquish voluntarily its status as a PSO, to request that these other
entities cease reporting or submitting any further information to the
PSO as soon as possible, and inform them that any information reported
after the effective date and time of delisting that the Secretary sets
pursuant to paragraph (c)(3) of this section will not be protected as
patient safety work product under the Patient Safety Act.
(ii) An attestation that the entity has established a plan, or
within 15 calendar days of this statement, will have made all reasonable
efforts to establish a plan, in consultation with the sources from which
it received patient safety work product, that provides for the
disposition of the patient safety work product held by the PSO
consistent with, to the extent practicable, the statutory options for
disposition of patient safety work product as set out in paragraph
(b)(3) of this section; and
(iii) Appropriate contact information for further communications
from the Secretary.
(3) Response to notification of voluntary relinquishment. (i) After
a PSO provides the notification required by paragraph (c)(2) of this
section, the Secretary will respond in writing to the entity indicating
whether the proposed voluntary relinquishment of its PSO status is
accepted. If the voluntary relinquishment is accepted, the Secretary's
response will indicate an effective date and time for the entity's
removal from the list of PSOs and will provide public notice of the
voluntary relinquishment and the effective date and time of the
delisting, in accordance with Sec. 3.108(d) of this subpart.
(ii) If the Secretary receives a notification of voluntary
relinquishment during or immediately after revocation proceedings for
cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary,
as a matter of discretion, may accept voluntary relinquishment in
accordance with the preceding paragraph or decide not to accept the
entity's proposed voluntary relinquishment and proceed with the
revocation for cause
[[Page 45]]
and delisting pursuant to paragraph (b)(1) of this section.
(4) Non-applicability of certain procedures and requirements. (i) A
decision by the Secretary to accept a request by a PSO to relinquish
voluntarily its status as a PSO pursuant to paragraph (c)(2) of this
section does not constitute a determination of a deficiency in PSO
compliance with the Patient Safety Act or with this Subpart.
(ii) The procedures and requirements of Sec. 3.108(a) of this
subpart regarding deficiencies including the opportunity to correct
deficiencies and to be heard in writing, and the procedures and
requirements of Sec. 3.108(b) are not applicable to determinations of
the Secretary made pursuant to this subsection.
(d) Public notice of delisting regarding removal from listing. If
the Secretary removes an entity from the list of PSOs following
revocation of acceptance of the entity's certification pursuant to Sec.
3.108(b)(1), voluntary relinquishment pursuant to Sec. 3.108(c)(3), or
expiration of an entity's period of listing pursuant to Sec.
3.104(e)(1), the Secretary will promptly publish in the Federal Register
and on the AHRQ PSO website, or in a comparable future form of public
notice, a notice of the actions taken and the effective dates.
(e) Expedited revocation and delisting--(1) Basis for expedited
revocation. Notwithstanding any other provision of this section, the
Secretary may use the expedited revocation process described in
paragraph (e)(3) of this section if he determines--
(i) The PSO is not in compliance with this part because it is or is
about to become an entity described in Sec. 3.102(a)(2).
(ii) The parent organization of the PSO is an entity described in
Sec. 3.102(a)(2) and requires or induces health care providers to
report patient safety work product to its component PSO; or
(iii) The circumstances for revocation in paragraph (a)(1) of this
section exist, and the Secretary has determined that there would be
serious adverse consequences if the PSO were to remain listed.
(2) Applicable provisions. If the Secretary uses the expedited
revocation process described in paragraph (e)(3) of this section, the
procedures in paragraphs (a)(2) through (5) of this section shall not
apply and paragraph (a)(1) and paragraphs (b) and (d) of this section
shall apply.
(3) Expedited revocation process. (i) The Secretary must send the
PSO a written notice of deficiency that:
(A) Identifies the evidence that the circumstances for revocation
and delisting under paragraph (a)(1) of this section exist, and any
corrective action that the PSO must take if the Secretary determines
that corrective action may resolve the matter so that the entity would
not be delisted; and
(B) Provides an opportunity for the PSO to respond in writing to
correct the facts or the legal bases for delisting found in the notice,
and to offer any other grounds for its not being delisted.
(ii) The notice of deficiency will be presumed to be received five
days after it is sent, absent evidence of the actual receipt date.
(iii) If the PSO does not submit a written response to the Secretary
within 14 calendar days of actual or constructive receipt of such
notice, whichever is longer, the Secretary may revoke his acceptance of
the PSO's certifications and remove the entity from the list of PSOs.
(iv) If the PSO responds in writing within the required 14-day time
period, the Secretary may take any of the following actions:
(A) Withdraw the notice of deficiency;
(B) Provide the PSO with more time to resolve the matter to the
Secretary's satisfaction; or
(C) Revoke his acceptance of the PSO's certifications and remove the
entity from the list of PSOs.
Sec. 3.110 Assessment of PSO compliance.
The Secretary may request information or conduct announced or
unannounced reviews of, or site visits to, PSOs, to assess or verify PSO
compliance with the requirements of this subpart and for these purposes
will be allowed to inspect the physical or virtual sites maintained or
controlled by the PSO. The Secretary will be allowed to inspect and/or
be given or sent copies of any PSO records deemed necessary
[[Page 46]]
and requested by the Secretary to implement the provisions of this
subpart. Such PSO records may include patient safety work product in
accordance with Sec. 3.206(d) of this part.
Sec. 3.112 Submissions and forms.
(a) Forms referred to in this subpart may be obtained on the PSO Web
site (http://www.pso.ahrq.gov) maintained for the Secretary by AHRQ or a
successor agency or on successor publication technology or by requesting
them in writing by e-mail at [email protected], or by mail from the
Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540
Gaither Road, Rockville, MD 20850. A form (including any required
attachments) must be submitted in accordance with the accompanying
instructions.
(b) Information submitted to AHRQ in writing, but not required to be
on or attached to a form, and requests for information from AHRQ, may be
submitted by mail or other delivery to the Agency for Healthcare
Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville,
MD 20850, by facsimile at (301) 427-1341, or by e-mail at
[email protected].
(c) If a submission to the Secretary is incomplete or additional
information is needed to allow a determination to be made under this
subpart, the submitter will be notified if any additional information is
required.
Subpart C_Confidentiality and Privilege Protections of Patient Safety
Work Product
Sec. 3.204 Privilege of patient safety work product.
(a) Privilege. Notwithstanding any other provision of Federal,
State, local, or Tribal law and subject to paragraph (b) of this section
and Sec. 3.208 of this subpart, patient safety work product shall be
privileged and shall not be:
(1) Subject to a Federal, State, local, or Tribal civil, criminal,
or administrative subpoena or order, including in a Federal, State,
local, or Tribal civil or administrative disciplinary proceeding against
a provider;
(2) Subject to discovery in connection with a Federal, State, local,
or Tribal civil, criminal, or administrative proceeding, including in a
Federal, State, local, or Tribal 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, local, or Tribal law;
(4) Admitted as evidence in any Federal, State, local, or Tribal
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) Exceptions to privilege. Privilege shall not apply to (and shall
not be construed to prohibit) one or more of the following disclosures:
(1) Disclosure of relevant patient safety work product for use in a
criminal proceeding, subject to the conditions at Sec. 3.206(b)(1) of
this subpart.
(2) Disclosure to the extent required to permit equitable relief
subject to the conditions at Sec. 3.206(b)(2) of this subpart.
(3) Disclosure pursuant to provider authorizations subject to the
conditions at Sec. 3.206(b)(3) of this subpart.
(4) Disclosure of non-identifiable patient safety work product
subject to the conditions at Sec. 3.206(b)(5) of this subpart.
(c) Implementation and enforcement by the Secretary. Privilege shall
not apply to (and shall not be construed to prohibit) disclosures of
relevant patient safety work product to or by the Secretary if such
patient safety work product is needed to investigate or determine
compliance, or to seek or impose civil money penalties, with respect to
this part or the HIPAA Privacy Rule, or to make or support decisions
with respect to listing of a PSO.
Sec. 3.206 Confidentiality of patient safety work product.
(a) Confidentiality. Subject to paragraphs (b) through (e) of this
section,
[[Page 47]]
and Sec. Sec. 3.208 and 3.210 of this subpart, patient safety work
product shall be confidential and shall not be disclosed.
(b) Exceptions to confidentiality. The confidentiality provisions
shall not apply to (and shall not be construed to prohibit) one or more
of the following disclosures:
(1) Disclosure in criminal proceedings. Disclosure of relevant
patient safety work product for use in a criminal proceeding, but only
after a court makes an in-camera determination that:
(i) Such patient safety work product contains evidence of a criminal
act;
(ii) Such patient safety work product is material to the proceeding;
and
(iii) Such patient safety work product is not reasonably available
from any other source.
(2) Disclosure to permit equitable relief for reporters. Disclosure
of patient safety work product to the extent required to permit
equitable relief under section 922 (f)(4)(A) of the Public Health
Service Act, provided the court or administrative tribunal has issued a
protective order to protect the confidentiality of the patient safety
work product in the course of the proceeding.
(3) Disclosure authorized by identified providers. (i) Disclosure of
identifiable patient safety work product consistent with a valid
authorization if such authorization is obtained from each provider
identified in such work product prior to disclosure. A valid
authorization must:
(A) Be in writing and signed by the provider from whom authorization
is sought; and
(B) Contain sufficient detail to fairly inform the provider of the
nature and scope of the disclosures being authorized;
(ii) A valid authorization must be retained by the disclosing entity
for six years from the date of the last disclosure made in reliance on
the authorization and made available to the Secretary upon request.
(4) Disclosure for patient safety activities--(i) Disclosure between
a provider and a PSO. Disclosure of patient safety work product for
patient safety activities by a provider to a PSO or by a PSO to that
disclosing provider.
(ii) Disclosure to a contractor of a provider or a PSO. A provider
or a PSO may disclose patient safety work product for patient safety
activities to an entity with which it has contracted to undertake
patient safety activities on its behalf. A contractor receiving patient
safety work product for patient safety activities may not further
disclose patient safety work product, except to the provider or PSO with
which it is contracted.
(iii) Disclosure among affiliated providers. Disclosure of patient
safety work product for patient safety activities by a provider to an
affiliated provider.
(iv) Disclosure to another PSO or provider. Disclosure of patient
safety work product for patient safety activities by a PSO to another
PSO or to another provider that has reported to the PSO, or, except as
otherwise permitted in paragraph (b)(4)(iii) of this section, by a
provider to another provider, provided:
(A) The following direct identifiers of any providers and of
affiliated organizations, corporate parents, subsidiaries, practice
partners, employers, members of the workforce, or household members of
such providers are removed:
(1) Names;
(2) Postal address information, other than town or city, State and
zip code;
(3) Telephone numbers;
(4) Fax numbers;
(5) Electronic mail addresses;
(6) Social security numbers or taxpayer identification numbers;
(7) Provider or practitioner credentialing or DEA numbers;
(8) National provider identification number;
(9) Certificate/license numbers;
(10) Web Universal Resource Locators (URLs);
(11) Internet Protocol (IP) address numbers;
(12) Biometric identifiers, including finger and voice prints; and
(13) Full face photographic images and any comparable images; and
(B) With respect to any individually identifiable health information
in such patient safety work product, the direct identifiers listed at 45
CFR 164.514(e)(2) have been removed.
[[Page 48]]
(5) Disclosure of nonidentifiable patient safety work product.
Disclosure of nonidentifiable patient safety work product when patient
safety work product meets the standard for nonidentification in
accordance with Sec. 3.212 of this subpart.
(6) Disclosure for research. (i) Disclosure of patient safety work
product to persons 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.
(ii) If the patient safety work product disclosed pursuant to
paragraph (b)(6)(i) of this section is by a HIPAA covered entity as
defined at 45 CFR 160.103 and contains protected health information as
defined by the HIPAA Privacy Rule at 45 CFR 160.103, such patient safety
work product may only be disclosed under this exception in the same
manner as would be permitted under the HIPAA Privacy Rule.
(7) Disclosure to the Food and Drug Administration (FDA) and
entities required to report to FDA. (i) Disclosure by a provider of
patient safety work product concerning an FDA-regulated product or
activity to the FDA, an entity required to report to the FDA concerning
the quality, safety, or effectiveness of an FDA-regulated product or
activity, or a contractor acting on behalf of FDA or such entity for
these purposes.
(ii) Any person permitted to receive patient safety work product
pursuant to paragraph (b)(7)(i) of this section may only further
disclose such patient safety work product for the purpose of evaluating
the quality, safety, or effectiveness of that product or activity to
another such person or the disclosing provider.
(8) Voluntary disclosure to an accrediting body. (i) Voluntary
disclosure by a provider of patient safety work product to an
accrediting body that accredits that provider, provided, with respect to
any identified provider other than the provider making the disclosure:
(A) The provider agrees to the disclosure; or
(B) The identifiers at Sec. 3.206(b)(4)(iv)(A) are removed.
(ii) An accrediting body may not further disclose patient safety
work product it receives pursuant to paragraph (b)(8)(i) of this
section.
(iii) An accrediting body may not take an accrediting action against
a provider based on a 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 PSO.
(9) Disclosure for business operations. (i) Disclosure of patient
safety work product by a provider or a PSO for business operations to
attorneys, accountants, and other professionals. Such contractors may
not further disclose patient safety work product, except to the entity
from which they received the information.
(ii) Disclosure of patient safety work product for such other
business operations that the Secretary may prescribe by regulation as
consistent with the goals of this part.
(10) Disclosure to law enforcement. (i) Disclosure of patient safety
work product to an appropriate law enforcement authority relating to an
event that either constitutes the commission of a crime, or for which
the disclosing person reasonably believes constitutes the commission of
a crime, provided that the disclosing person believes, reasonably under
the circumstances, that the patient safety work product that is
disclosed is necessary for criminal law enforcement purposes.
(ii) Law enforcement personnel receiving patient safety work product
pursuant to paragraph (b)(10)(i) of this section only may disclose that
patient safety work product to other law enforcement authorities as
needed for law enforcement activities related to the event that gave
rise to the disclosure under paragraph (b)(10)(i) of this section.
(c) Safe harbor. A provider or responsible person, but not a PSO, is
not considered to have violated the requirements of this subpart if a
member of its workforce discloses patient safety work product, provided
that the disclosure does not include materials, including oral
statements, that:
(1) Assess the quality of care of an identifiable provider; or
[[Page 49]]
(2) Describe or pertain to one or more actions or failures to act by
an identifiable provider.
(d) Implementation and enforcement by the Secretary. The
confidentiality provisions shall not apply to (and shall not be
construed to prohibit) disclosures of relevant patient safety work
product to or by the Secretary if such patient safety work product is
needed to investigate or determine compliance or to seek or impose civil
money penalties, with respect to this part or the HIPAA Privacy Rule, or
to make or support decisions with respect to listing of a PSO.
(e) No limitation on authority to limit or delegate disclosure or
use. Nothing in subpart C of this part shall be construed to limit the
authority of any person to enter into a contract requiring greater
confidentiality or delegating authority to make a disclosure or use in
accordance with this subpart.
Sec. 3.208 Continued protection of patient safety work product.
(a) Except as provided in paragraph (b) of this section, patient
safety work product disclosed in accordance with this subpart, or
disclosed impermissibly, shall continue to be privileged and
confidential.
(b)(1) Patient safety work product disclosed for use in a criminal
proceeding pursuant to section 922(c)(1)(A) of the Public Health Service
Act, 42 U.S.C. 299b-22(c)(1)(A), and/or pursuant to Sec. 3.206(b)(1) of
this subpart continues to be privileged, but is no longer confidential.
(2) Non-identifiable patient safety work product that is disclosed
is no longer privileged or confidential and not subject to the
regulations under this part.
(3) Paragraph (b) of this section applies only to the specific
patient safety work product disclosed.
Sec. 3.210 Required disclosure of patient safety work product to the
Secretary.
Notwithstanding any other provision in this part, providers, PSOs,
and responsible persons must disclose patient safety work product upon
request by the Secretary when the Secretary determines such patient
safety work product is needed to investigate or determine compliance or
to seek or impose civil money penalties, with respect to this part or
the HIPAA Privacy Rule, or to make or support decisions with respect to
listing of a PSO.
Sec. 3.212 Nonidentification of patient safety work product.
(a) Patient safety work product is nonidentifiable with respect to a
particular identified provider or a particular identified reporter if:
(1) A person with appropriate knowledge of and experience with
generally accepted statistical and scientific principles and methods for
rendering information not individually identifiable:
(i) Applying such principles and methods, determines that the risk
is very small that the information could be used, alone or in
combination with other reasonably available information, by an
anticipated recipient to identify an identified provider or reporter;
and
(ii) Documents the methods and results of the analysis that justify
such determination; or
(2)(i) The following identifiers of such provider or reporter and of
affiliated organizations, corporate parents, subsidiaries, practice
partners, employers, members of the workforce, or household members of
such providers or reporters are removed:
(A) The direct identifiers listed at Sec. 3.206(b)(4)(iv)(A)(1)
through (13) of this subpart;
(B) Geographic subdivisions smaller than a State, including street
address, city, county, precinct, zip code and equivalent geocodes,
except for the initial three digits of a zip code if, according to the
current publicly available data from the Bureau of the Census, the
geographic unit formed by combining all zip codes with the same three
initial digits contains more than 20,000 people;
(C) All elements of dates (except year) for dates directly related
to a patient safety incident or event; and
(D) Any other unique identifying number, characteristic, or code
except as permitted for re-identification; and
(ii) The provider, PSO or responsible person making the disclosure
does not
[[Page 50]]
have actual knowledge that the information could be used, alone or in
combination with other information that is reasonably available to the
intended recipient, to identify the particular provider or reporter.
(3) Re-identification. A provider, PSO, or responsible person may
assign a code or other means of record identification to allow
information made nonidentifiable under this section to be re-identified
by such provider, PSO, or responsible person, provided that:
(i) The code or other means of record identification is not derived
from or related to information about the provider or reporter and is not
otherwise capable of being translated so as to identify the provider or
reporter; and
(ii) The provider, PSO, or responsible person does not use or
disclose the code or other means of record identification for any other
purpose, and does not disclose the mechanism for re-identification.
(b) Patient safety work product is non-identifiable with respect to
a particular patient only if the individually identifiable health
information regarding that patient is de-identified in accordance with
the HIPAA Privacy Rule standard and implementation specifications for
the de-identification at 45 CFR 164.514(a) through (c).
Subpart D_Enforcement Program
Sec. 3.304 Principles for achieving compliance.
(a) Cooperation. The Secretary will, to the extent practicable, seek
the cooperation of providers, PSOs, and responsible persons in obtaining
compliance with the applicable confidentiality provisions.
(b) Assistance. The Secretary may provide technical assistance to
providers, PSOs, and responsible persons to help them comply voluntarily
with the applicable confidentiality provisions.
Sec. 3.306 Complaints to the Secretary.
(a) Right to file a complaint. A person who believes that patient
safety work product has been disclosed in violation of the
confidentiality provisions may file a complaint with the Secretary.
(b) Requirements for filing complaints. Complaints under this
section must meet the following requirements:
(1) A complaint must be filed in writing, either on paper or
electronically.
(2) A complaint must name the person that is the subject of the
complaint and describe the act(s) believed to be in violation of the
applicable confidentiality provision(s).
(3) A complaint must be filed within 180 days of when the
complainant knew or should have known that the act complained of
occurred, unless this time limit is waived by the Secretary for good
cause shown.
(4) The Secretary may prescribe additional procedures for the filing
of complaints, as well as the place and manner of filing, by notice in
the Federal Register.
(c) Investigation. The Secretary may investigate complaints filed
under this section. Such investigation may include a review of the
pertinent policies, procedures, or practices of the respondent and of
the circumstances regarding any alleged violation. At the time of
initial written communication with the respondent about the complaint,
the Secretary will describe the act(s) that are the basis of the
complaint.
Sec. 3.308 Compliance reviews.
The Secretary may conduct compliance reviews to determine whether a
respondent is complying with the applicable confidentiality provisions.
Sec. 3.310 Responsibilities of respondents.
(a) Provide records and compliance reports. A respondent must keep
such records and submit such compliance reports, in such time and manner
and containing such information, as the Secretary may determine to be
necessary to enable the Secretary to ascertain whether the respondent
has complied or is complying with the applicable confidentiality
provisions.
(b) Cooperate with complaint investigations and compliance reviews.
A respondent must cooperate with the Secretary, if the Secretary
undertakes an investigation or compliance review of the policies,
procedures, or practices of the respondent to determine whether it is
complying with the applicable confidentiality provisions.
[[Page 51]]
(c) Permit access to information. (1) A respondent must permit
access by the Secretary during normal business hours to its facilities,
books, records, accounts, and other sources of information, including
patient safety work product, that are pertinent to ascertaining
compliance with the applicable confidentiality provisions. If the
Secretary determines that exigent circumstances exist, such as when
documents may be hidden or destroyed, a respondent must permit access by
the Secretary at any time and without notice.
(2) If any information required of a respondent under this section
is in the exclusive possession of any other agency, institution, or
person, and the other agency, institution, or person fails or refuses to
furnish the information, the respondent must so certify and set forth
what efforts it has made to obtain the information.
Sec. 3.312 Secretarial action regarding complaints and compliance
reviews.
(a) Resolution when noncompliance is indicated. (1) If an
investigation of a complaint pursuant to Sec. 3.306 of this subpart or
a compliance review pursuant to Sec. 3.308 of this subpart indicates
noncompliance, the Secretary may attempt to reach a resolution of the
matter satisfactory to the Secretary by informal means. Informal means
may include demonstrated compliance or a completed corrective action
plan or other agreement.
(2) If the matter is resolved by informal means, the Secretary will
so inform the respondent and, if the matter arose from a complaint, the
complainant, in writing.
(3) If the matter is not resolved by informal means, the Secretary
will--
(i) So inform the respondent and provide the respondent an
opportunity to submit written evidence of any mitigating factors. The
respondent must submit any evidence to the Secretary within 30 days
(computed in the same manner as prescribed under Sec. 3.526 of this
subpart) of receipt of such notification; and
(ii) If, following action pursuant to paragraph (a)(3)(i) of this
section, the Secretary decides that a civil money penalty should be
imposed, inform the respondent of such finding in a notice of proposed
determination in accordance with Sec. 3.420 of this subpart.
(b) Resolution when no violation is found. If, after an
investigation pursuant to Sec. 3.306 of this subpart or a compliance
review pursuant to Sec. 3.308 of this subpart, the Secretary determines
that further action is not warranted, the Secretary will so inform the
respondent and, if the matter arose from a complaint, the complainant,
in writing.
(c) Uses and disclosures of information obtained. (1) Identifiable
patient safety work product obtained by the Secretary in connection with
an investigation or compliance review under this subpart will not be
disclosed by the Secretary, except in accordance with Sec. 3.206(d) of
this subpart, or if otherwise permitted by this part or the Patient
Safety Act.
(2) Except as provided for in paragraph (c)(1) of this section,
information, including testimony and other evidence, obtained by the
Secretary in connection with an investigation or compliance review under
this subpart may be used by HHS in any of its activities and may be used
or offered into evidence in any administrative or judicial proceeding.
Sec. 3.314 Investigational subpoenas and inquiries.
(a) The Secretary may issue subpoenas in accordance with 42 U.S.C.
405(d) and (e), and 1320a-7a(j), to require the attendance and testimony
of witnesses and the production of any other evidence including patient
safety work product during an investigation or compliance review
pursuant to this part.
(1) A subpoena issued under this paragraph must--
(i) State the name of the person (including the entity, if
applicable) to whom the subpoena is addressed;
(ii) State the statutory authority for the subpoena;
(iii) Indicate the date, time, and place that the testimony will
take place;
(iv) Include a reasonably specific description of any documents or
items required to be produced; and
[[Page 52]]
(v) If the subpoena is addressed to an entity, describe with
reasonable particularity the subject matter on which testimony is
required. In that event, the entity must designate one or more natural
persons who will testify on its behalf, and must state as to each such
person that person's name and address and the matters on which he or she
will testify. The designated person must testify as to matters known or
reasonably available to the entity.
(2) A subpoena under this section must be served by--
(i) Delivering a copy to the natural person named in the subpoena or
to the entity named in the subpoena at its last principal place of
business; or
(ii) Registered or certified mail addressed to the natural person at
his or her last known dwelling place or to the entity at its last known
principal place of business.
(3) A verified return by the natural person serving the subpoena
setting forth the manner of service or, in the case of service by
registered or certified mail, the signed return post office receipt,
constitutes proof of service.
(4) Witnesses are entitled to the same fees and mileage as witnesses
in the district courts of the United States (28 U.S.C. 1821 and 1825).
Fees need not be paid at the time the subpoena is served.
(5) A subpoena under this section is enforceable through the
district court of the United States for the district where the
subpoenaed natural person resides or is found or where the entity
transacts business.
(b) Investigational inquiries are non-public investigational
proceedings conducted by the Secretary.
(1) Testimony at investigational inquiries will be taken under oath
or affirmation.
(2) Attendance of non-witnesses is discretionary with the Secretary,
except that a witness is entitled to be accompanied, represented, and
advised by an attorney.
(3) Representatives of the Secretary are entitled to attend and ask
questions.
(4) A witness will have the opportunity to clarify his or her
answers on the record following questioning by the Secretary.
(5) Any claim of privilege must be asserted by the witness on the
record.
(6) Objections must be asserted on the record. Errors of any kind
that might be corrected if promptly presented will be deemed to be
waived unless reasonable objection is made at the investigational
inquiry. Except where the objection is on the grounds of privilege, the
question will be answered on the record, subject to objection.
(7) If a witness refuses to answer any question not privileged or to
produce requested documents or items, or engages in conduct likely to
delay or obstruct the investigational inquiry, the Secretary may seek
enforcement of the subpoena under paragraph (a)(5) of this section.
(8) The proceedings will be recorded and transcribed. The witness is
entitled to a copy of the transcript, upon payment of prescribed costs,
except that, for good cause, the witness may be limited to inspection of
the official transcript of his or her testimony.
(9)(i) The transcript will be submitted to the witness for
signature.
(A) Where the witness will be provided a copy of the transcript, the
transcript will be submitted to the witness for signature. The witness
may submit to the Secretary written proposed corrections to the
transcript, with such corrections attached to the transcript. If the
witness does not return a signed copy of the transcript or proposed
corrections within 30 days (computed in the same manner as prescribed
under Sec. 3.526 of this part) of its being submitted to him or her for
signature, the witness will be deemed to have agreed that the transcript
is true and accurate.
(B) Where, as provided in paragraph (b)(8) of this section, the
witness is limited to inspecting the transcript, the witness will have
the opportunity at the time of inspection to propose corrections to the
transcript, with corrections attached to the transcript. The witness
will also have the opportunity to sign the transcript. If the witness
does not sign the transcript or offer corrections within 30 days
(computed in the same manner as prescribed
[[Page 53]]
under Sec. 3.526 of this part) of receipt of notice of the opportunity
to inspect the transcript, the witness will be deemed to have agreed
that the transcript is true and accurate.
(ii) The Secretary's proposed corrections to the record of
transcript will be attached to the transcript.
Sec. 3.402 Basis for a civil money penalty.
(a) General rule. A person who discloses identifiable patient safety
work product in knowing or reckless violation of the confidentiality
provisions shall be subject to a civil money penalty for each act
constituting such violation.
(b) Violation attributed to a principal. A principal is
independently liable, in accordance with the federal common law of
agency, for a civil money penalty based on the act of the principal's
agent, including a workforce member, acting within the scope of the
agency if such act could give rise to a civil money penalty in
accordance with Sec. 3.402(a) of this subpart.
Sec. 3.404 Amount of a civil money penalty.
(a) The amount of a civil money penalty will be determined in
accordance with paragraph (b) of this section and Sec. 3.408 of this
subpart.
(b) The Secretary may impose a civil money penalty in the amount of
not more than $11,000.
[73 FR 70796, Nov. 21, 2008, as amended at 74 FR 42779, Aug. 25, 2009]
Sec. 3.408 Factors considered in determining the amount of a civil
money penalty.
In determining the amount of any civil money penalty, the Secretary
may consider as aggravating or mitigating factors, as appropriate, any
of the following:
(a) The nature of the violation.
(b) The circumstances, including the consequences, of the violation,
including:
(1) The time period during which the violation(s) occurred; and
(2) Whether the violation caused physical or financial harm or
reputational damage;
(c) The degree of culpability of the respondent, including:
(1) Whether the violation was intentional; and
(2) Whether the violation was beyond the direct control of the
respondent.
(d) Any history of prior compliance with the Patient Safety Act,
including violations, by the respondent, including:
(1) Whether the current violation is the same or similar to prior
violation(s);
(2) Whether and to what extent the respondent has attempted to
correct previous violations;
(3) How the respondent has responded to technical assistance from
the Secretary provided in the context of a compliance effort; and
(4) How the respondent has responded to prior complaints.
(e) The financial condition of the respondent, including:
(1) Whether the respondent had financial difficulties that affected
its ability to comply;
(2) Whether the imposition of a civil money penalty would jeopardize
the ability of the respondent to continue to provide health care or
patient safety activities; and
(3) The size of the respondent.
(f) Such other matters as justice may require.
Sec. 3.414 Limitations.
No action under this subpart may be entertained unless commenced by
the Secretary, in accordance with Sec. 3.420 of this subpart, within 6
years from the date of the occurrence of the violation.
Sec. 3.416 Authority to settle.
Nothing in this subpart limits the authority of the Secretary to
settle any issue or case or to compromise any penalty.
Sec. 3.418 Exclusivity of penalty.
(a) Except as otherwise provided by paragraph (b) of this section, a
penalty imposed under this part is in addition to any other penalty
prescribed by law.
(b) Civil money penalties shall not be imposed both under this part
and under the HIPAA Privacy Rule (45 CFR parts 160 and 164).
[[Page 54]]
Sec. 3.420 Notice of proposed determination.
(a) If a penalty is proposed in accordance with this part, the
Secretary must deliver, or send by certified mail with return receipt
requested, to the respondent, written notice of the Secretary's intent
to impose a penalty. This notice of proposed determination must include:
(1) Reference to the statutory basis for the penalty;
(2) A description of the findings of fact regarding the violations
with respect to which the penalty is proposed;
(3) The reason(s) why the violation(s) subject(s) the respondent to
a penalty;
(4) The amount of the proposed penalty;
(5) Any factors described in Sec. 3.408 of this subpart that were
considered in determining the amount of the proposed penalty; and
(6) Instructions for responding to the notice, including a statement
of the respondent's right to a hearing, a statement that failure to
request a hearing within 60 days permits the imposition of the proposed
penalty without the right to a hearing under Sec. 3.504 of this subpart
or a right of appeal under Sec. 3.548 of this subpart, and the address
to which the hearing request must be sent.
(b) The respondent may request a hearing before an ALJ on the
proposed penalty by filing a request in accordance with Sec. 3.504 of
this subpart.
Sec. 3.422 Failure to request a hearing.
If the respondent does not request a hearing within the time
prescribed by Sec. 3.504 of this subpart and the matter is not settled
pursuant to Sec. 3.416 of this subpart, the Secretary may impose the
proposed penalty or any lesser penalty permitted by sections 921 through
926 of the Public Health Service Act, 42 U.S.C. 299b-21 through 299b-26.
The Secretary will notify the respondent by certified mail, return
receipt requested, of any penalty that has been imposed and of the means
by which the respondent may satisfy the penalty, and the penalty is
final on receipt of the notice. The respondent has no right to appeal a
penalty under Sec. 3.548 of this subpart with respect to which the
respondent has not timely requested a hearing.
Sec. 3.424 Collection of penalty.
(a) Once a determination of the Secretary to impose a penalty has
become final, the penalty will be collected by the Secretary, subject to
the first sentence of 42 U.S.C. 1320a-7a(f).
(b) The penalty may be recovered in a civil action brought in the
United States district court for the district where the respondent
resides, is found, or is located.
(c) The amount of a penalty, when finally determined, or the amount
agreed upon in compromise, may be deducted from any sum then or later
owing by the United States, or by a State agency, to the respondent.
(d) Matters that were raised or that could have been raised in a
hearing before an ALJ, or in an appeal under 42 U.S.C. 1320a-7a(e), may
not be raised as a defense in a civil action by the United States to
collect a penalty under this part.
Sec. 3.426 Notification of the public and other agencies.
Whenever a proposed penalty becomes final, the Secretary will
notify, in such manner as the Secretary deems appropriate, the public
and the following organizations and entities thereof and the reason it
was imposed: The appropriate State or local medical or professional
organization, the appropriate State agency or agencies administering or
supervising the administration of State health care programs (as defined
in 42 U.S.C. 1320a-7(h)), the appropriate utilization and quality
control peer review organization, and the appropriate State or local
licensing agency or organization (including the agency specified in 42
U.S.C. 1395aa(a), 1396a(a)(33)).
Sec. 3.504 Hearings before an ALJ.
(a) A respondent may request a hearing before an ALJ. The parties to
the hearing proceeding consist of--
(1) The respondent; and
(2) The officer(s) or employee(s) of HHS to whom the enforcement
authority involved has been delegated.
[[Page 55]]
(b) The request for a hearing must be made in writing signed by the
respondent or by the respondent's attorney and sent by certified mail,
return receipt requested, to the address specified in the notice of
proposed determination. The request for a hearing must be mailed within
60 days after notice of the proposed determination is received by the
respondent. For purposes of this section, the respondent's date of
receipt of the notice of proposed determination is presumed to be 5 days
after the date of the notice unless the respondent makes a reasonable
showing to the contrary to the ALJ.
(c) The request for a hearing must clearly and directly admit, deny,
or explain each of the findings of fact contained in the notice of
proposed determination with regard to which the respondent has any
knowledge. If the respondent has no knowledge of a particular finding of
fact and so states, the finding shall be deemed denied. The request for
a hearing must also state the circumstances or arguments that the
respondent alleges constitute the grounds for any defense and the
factual and legal basis for opposing the penalty.
(d) The ALJ must dismiss a hearing request where--
(1) On motion of the Secretary, the ALJ determines that the
respondent's hearing request is not timely filed as required by
paragraph (b) or does not meet the requirements of paragraph (c) of this
section;
(2) The respondent withdraws the request for a hearing;
(3) The respondent abandons the request for a hearing; or
(4) The respondent's hearing request fails to raise any issue that
may properly be addressed in a hearing.
Sec. 3.506 Rights of the parties.
(a) Except as otherwise limited by this subpart, each party may--
(1) Be accompanied, represented, and advised by an attorney;
(2) Participate in any conference held by the ALJ;
(3) Conduct discovery of documents as permitted by this subpart;
(4) Agree to stipulations of fact or law that will be made part of
the record;
(5) Present evidence relevant to the issues at the hearing;
(6) Present and cross-examine witnesses;
(7) Present oral arguments at the hearing as permitted by the ALJ;
and
(8) Submit written briefs and proposed findings of fact and
conclusions of law after the hearing.
(b) A party may appear in person or by a representative. Natural
persons who appear as an attorney or other representative must conform
to the standards of conduct and ethics required of practitioners before
the courts of the United States.
(c) Fees for any services performed on behalf of a party by an
attorney are not subject to the provisions of 42 U.S.C. 406, which
authorizes the Secretary to specify or limit their fees.
Sec. 3.508 Authority of the ALJ.
(a) The ALJ must conduct a fair and impartial hearing, avoid delay,
maintain order, and ensure that a record of the proceeding is made.
(b) The ALJ may--
(1) Set and change the date, time and place of the hearing upon
reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a
reasonable period of time;
(3) Hold conferences to identify or simplify the issues, or to
consider other matters that may aid in the expeditious disposition of
the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance of witnesses at
hearings and the production of documents at or in relation to hearings;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of documentary discovery as
permitted by this subpart;
(8) Regulate the course of the hearing and the conduct of
representatives, parties, and witnesses;
(9) Examine witnesses;
(10) Receive, rule on, exclude, or limit evidence;
(11) Upon motion of a party, take official notice of facts;
(12) Conduct any conference, argument or hearing in person or, upon
[[Page 56]]
agreement of the parties, by telephone; and
(13) Upon motion of a party, decide cases, in whole or in part, by
summary judgment where there is no disputed issue of material fact. A
summary judgment decision constitutes a hearing on the record for the
purposes of this subpart.
(c) The ALJ--
(1) May not find invalid or refuse to follow Federal statutes,
regulations, or Secretarial delegations of authority and must give
deference to published guidance to the extent not inconsistent with
statute or regulation;
(2) May not enter an order in the nature of a directed verdict;
(3) May not compel settlement negotiations; or
(4) May not enjoin any act of the Secretary.
Sec. 3.510 Ex parte contacts.
No party or person (except employees of the ALJ's office) may
communicate in any way with the ALJ on any matter at issue in a case,
unless on notice and opportunity for both parties to participate. This
provision does not prohibit a party or person from inquiring about the
status of a case or asking routine questions concerning administrative
functions or procedures.
Sec. 3.512 Prehearing conferences.
(a) The ALJ must schedule at least one prehearing conference, and
may schedule additional prehearing conferences as appropriate, upon
reasonable notice, which may not be less than 14 business days, to the
parties.
(b) The ALJ may use prehearing conferences to discuss the
following--
(1) Simplification of the issues;
(2) The necessity or desirability of amendments to the pleadings,
including the need for a more definite statement;
(3) Stipulations and admissions of fact or as to the contents and
authenticity of documents;
(4) Whether the parties can agree to submission of the case on a
stipulated record;
(5) Whether a party chooses to waive appearance at an oral hearing
and to submit only documentary evidence (subject to the objection of the
other party) and written argument;
(6) Limitation of the number of witnesses;
(7) Scheduling dates for the exchange of witness lists and of
proposed exhibits;
(8) Discovery of documents as permitted by this subpart;
(9) The time and place for the hearing;
(10) The potential for the settlement of the case by the parties;
and
(11) Other matters as may tend to encourage the fair, just and
expeditious disposition of the proceedings, including the protection of
confidentiality of identifiable patient safety work product that may be
submitted into evidence or otherwise used in the proceeding, if
appropriate.
(c) The ALJ must issue an order containing the matters agreed upon
by the parties or ordered by the ALJ at a prehearing conference.
Sec. 3.514 Authority to settle.
The Secretary has exclusive authority to settle any issue or case
without the consent of the ALJ.
Sec. 3.516 Discovery.
(a) A party may make a request to another party for production of
documents for inspection and copying that are relevant and material to
the issues before the ALJ.
(b) For the purpose of this section, the term ``documents'' includes
information, reports, answers, records, accounts, papers and other data
and documentary evidence. Nothing contained in this section may be
interpreted to require the creation of a document, except that requested
data stored in an electronic data storage system must be produced in a
form accessible to the requesting party.
(c) Requests for documents, requests for admissions, written
interrogatories, depositions and any forms of discovery, other than
those permitted under paragraph (a) of this section, are not authorized.
(d) This section may not be construed to require the disclosure of
interview reports or statements obtained by any party, or on behalf of
any party, of persons who will not be called as witnesses
[[Page 57]]
by that party, or analyses and summaries prepared in conjunction with
the investigation or litigation of the case, or any otherwise privileged
documents.
(e)(1) When a request for production of documents has been received,
within 30 days the party receiving that request must either fully
respond to the request, or state that the request is being objected to
and the reasons for that objection. If objection is made to part of an
item or category, the part must be specified. Upon receiving any
objections, the party seeking production may then, within 30 days or any
other time frame set by the ALJ, file a motion for an order compelling
discovery. The party receiving a request for production may also file a
motion for protective order any time before the date the production is
due.
(2) The ALJ may grant a motion for protective order or deny a motion
for an order compelling discovery if the ALJ finds that the discovery
sought--
(i) Is irrelevant;
(ii) Is unduly costly or burdensome;
(iii) Will unduly delay the proceeding; or
(iv) Seeks privileged information.
(3) The ALJ may extend any of the time frames set forth in paragraph
(e)(1) of this section.
(4) The burden of showing that discovery should be allowed is on the
party seeking discovery.
Sec. 3.518 Exchange of witness lists, witness statements, and exhibits.
(a) The parties must exchange witness lists, copies of prior written
statements of proposed witnesses, and copies of proposed hearing
exhibits, including copies of any written statements that the party
intends to offer in lieu of live testimony in accordance with Sec.
3.538, not more than 60, and not less than 15, days before the scheduled
hearing.
(b)(1) If, at any time, a party objects to the proposed admission of
evidence not exchanged in accordance with paragraph (a) of this section,
the ALJ must determine whether the failure to comply with paragraph (a)
of this section should result in the exclusion of that evidence.
(2) Unless the ALJ finds that extraordinary circumstances justified
the failure timely to exchange the information listed under paragraph
(a) of this section, the ALJ must exclude from the party's case-in-
chief--
(i) The testimony of any witness whose name does not appear on the
witness list; and
(ii) Any exhibit not provided to the opposing party as specified in
paragraph (a) of this section.
(3) If the ALJ finds that extraordinary circumstances existed, the
ALJ must then determine whether the admission of that evidence would
cause substantial prejudice to the objecting party.
(i) If the ALJ finds that there is no substantial prejudice, the
evidence may be admitted.
(ii) If the ALJ finds that there is substantial prejudice, the ALJ
may exclude the evidence, or, if he or she does not exclude the
evidence, must postpone the hearing for such time as is necessary for
the objecting party to prepare and respond to the evidence, unless the
objecting party waives postponement.
(c) Unless the other party objects within a reasonable period of
time before the hearing, documents exchanged in accordance with
paragraph (a) of this section will be deemed to be authentic for the
purpose of admissibility at the hearing.
Sec. 3.520 Subpoenas for attendance at hearing.
(a) A party wishing to procure the appearance and testimony of any
person at the hearing may make a motion requesting the ALJ to issue a
subpoena if the appearance and testimony are reasonably necessary for
the presentation of a party's case.
(b) A subpoena requiring the attendance of a person in accordance
with paragraph (a) of this section may also require the person (whether
or not the person is a party) to produce relevant and material evidence
at or before the hearing.
(c) When a subpoena is served by a respondent on a particular
employee or official or particular office of HHS, the Secretary may
comply by designating
[[Page 58]]
any knowledgeable HHS representative to appear and testify.
(d) A party seeking a subpoena must file a written motion not less
than 30 days before the date fixed for the hearing, unless otherwise
allowed by the ALJ for good cause shown. That motion must--
(1) Specify any evidence to be produced;
(2) Designate the witnesses; and
(3) Describe the address and location with sufficient particularity
to permit those witnesses to be found.
(e) The subpoena must specify the time and place at which the
witness is to appear and any evidence the witness is to produce.
(f) Within 15 days after the written motion requesting issuance of a
subpoena is served, any party may file an opposition or other response.
(g) If the motion requesting issuance of a subpoena is granted, the
party seeking the subpoena must serve it by delivery to the person
named, or by certified mail addressed to that person at the person's
last dwelling place or principal place of business.
(h) The person to whom the subpoena is directed may file with the
ALJ a motion to quash the subpoena within 10 days after service.
(i) The exclusive remedy for contumacy by, or refusal to obey a
subpoena duly served upon, any person is specified in 42 U.S.C. 405(e).
Sec. 3.522 Fees.
The party requesting a subpoena must pay the cost of the fees and
mileage of any witness subpoenaed in the amounts that would be payable
to a witness in a proceeding in United States District Court. A check
for witness fees and mileage must accompany the subpoena when served,
except that, when a subpoena is issued on behalf of the Secretary, a
check for witness fees and mileage need not accompany the subpoena.
Sec. 3.524 Form, filing, and service of papers.
(a) Forms. (1) Unless the ALJ directs the parties to do otherwise,
documents filed with the ALJ must include an original and two copies.
(2) Every pleading and paper filed in the proceeding must contain a
caption setting forth the title of the action, the case number, and a
designation of the paper, such as motion to quash subpoena.
(3) Every pleading and paper must be signed by and must contain the
address and telephone number of the party or the person on whose behalf
the paper was filed, or his or her representative.
(4) Papers are considered filed when they are mailed.
(b) Service. A party filing a document with the ALJ or the Board
must, at the time of filing, serve a copy of the document on the other
party. Service upon any party of any document must be made by delivering
a copy, or placing a copy of the document in the United States mail,
postage prepaid and addressed, or with a private delivery service, to
the party's last known address. When a party is represented by an
attorney, service must be made upon the attorney in lieu of the party.
(c) Proof of service. A certificate of the natural person serving
the document by personal delivery or by mail, setting forth the manner
of service, constitutes proof of service.
Sec. 3.526 Computation of time.
(a) In computing any period of time under this subpart or in an
order issued thereunder, the time begins with the day following the act,
event or default, and includes the last day of the period unless it is a
Saturday, Sunday, or legal holiday observed by the Federal Government,
in which event it includes the next business day.
(b) When the period of time allowed is less than 7 days,
intermediate Saturdays, Sundays, and legal holidays observed by the
Federal Government must be excluded from the computation.
(c) Where a document has been served or issued by placing it in the
mail, an additional 5 days must be added to the time permitted for any
response. This paragraph does not apply to requests for hearing under
Sec. 3.504.
Sec. 3.528 Motions.
(a) An application to the ALJ for an order or ruling must be by
motion. Motions must state the relief sought, the
[[Page 59]]
authority relied upon and the facts alleged, and must be filed with the
ALJ and served on all other parties.
(b) Except for motions made during a prehearing conference or at the
hearing, all motions must be in writing. The ALJ may require that oral
motions be reduced to writing.
(c) Within 10 days after a written motion is served, or such other
time as may be fixed by the ALJ, any party may file a response to the
motion.
(d) The ALJ may not grant a written motion before the time for
filing responses has expired, except upon consent of the parties or
following a hearing on the motion, but may overrule or deny the motion
without awaiting a response.
(e) The ALJ must make a reasonable effort to dispose of all
outstanding motions before the beginning of the hearing.
Sec. 3.530 Sanctions.
The ALJ may sanction a person, including any party or attorney, for
failing to comply with an order or procedure, for failing to defend an
action or for other misconduct that interferes with the speedy, orderly
or fair conduct of the hearing. The sanctions must reasonably relate to
the severity and nature of the failure or misconduct. The sanctions may
include--
(a) In the case of refusal to provide or permit discovery under the
terms of this part, drawing negative factual inferences or treating the
refusal as an admission by deeming the matter, or certain facts, to be
established;
(b) Prohibiting a party from introducing certain evidence or
otherwise supporting a particular claim or defense;
(c) Striking pleadings, in whole or in part;
(d) Staying the proceedings;
(e) Dismissal of the action;
(f) Entering a decision by default;
(g) Ordering the party or attorney to pay the attorney's fees and
other costs caused by the failure or misconduct; and
(h) Refusing to consider any motion or other action that is not
filed in a timely manner.
Sec. 3.532 Collateral estoppel.
When a final determination that the respondent violated a
confidentiality provision has been rendered in any proceeding in which
the respondent was a party and had an opportunity to be heard, the
respondent is bound by that determination in any proceeding under this
part.
Sec. 3.534 The hearing.
(a) The ALJ must conduct a hearing on the record in order to
determine whether the respondent should be found liable under this part.
(b)(1) The respondent has the burden of going forward and the burden
of persuasion with respect to any challenge to the amount of a proposed
penalty pursuant to Sec. Sec. 3.404 and 3.408, including any factors
raised as mitigating factors.
(2) The Secretary has the burden of going forward and the burden of
persuasion with respect to all other issues, including issues of
liability and the existence of any factors considered as aggravating
factors in determining the amount of the proposed penalty.
(3) The burden of persuasion will be judged by a preponderance of
the evidence.
(c) The hearing must be open to the public unless otherwise ordered
by the ALJ for good cause shown, which may be that identifiable patient
safety work product has been introduced into evidence or is expected to
be introduced into evidence.
(d)(1) Subject to the 15-day rule under Sec. 3.518(a) and the
admissibility of evidence under Sec. 3.540, either party may introduce,
during its case in chief, items or information that arose or became
known after the date of the issuance of the notice of proposed
determination or the request for hearing, as applicable. Such items and
information may not be admitted into evidence, if introduced--
(i) By the Secretary, unless they are material and relevant to the
acts or omissions with respect to which the penalty is proposed in the
notice of proposed determination pursuant to Sec. 3.420 of this part,
including circumstances that may increase penalties; or
[[Page 60]]
(ii) By the respondent, unless they are material and relevant to an
admission, denial or explanation of a finding of fact in the notice of
proposed determination under Sec. 3.420 of this part, or to a specific
circumstance or argument expressly stated in the request for hearing
under Sec. 3.504, including circumstances that may reduce penalties.
(2) After both parties have presented their cases, evidence may be
admitted in rebuttal even if not previously exchanged in accordance with
Sec. 3.518.
Sec. 3.538 Witnesses.
(a) Except as provided in paragraph (b) of this section, testimony
at the hearing must be given orally by witnesses under oath or
affirmation.
(b) At the discretion of the ALJ, testimony of witnesses other than
the testimony of expert witnesses may be admitted in the form of a
written statement. The ALJ may, at his or her discretion, admit prior
sworn testimony of experts that has been subject to adverse examination,
such as a deposition or trial testimony. Any such written statement must
be provided to the other party, along with the last known address of the
witness, in a manner that allows sufficient time for the other party to
subpoena the witness for cross-examination at the hearing. Prior written
statements of witnesses proposed to testify at the hearing must be
exchanged as provided in Sec. 3.518.
(c) The ALJ must exercise reasonable control over the mode and order
of interrogating witnesses and presenting evidence so as to:
(1) Make the interrogation and presentation effective for the
ascertainment of the truth;
(2) Avoid repetition or needless consumption of time; and
(3) Protect witnesses from harassment or undue embarrassment.
(d) The ALJ must permit the parties to conduct cross-examination of
witnesses as may be required for a full and true disclosure of the
facts.
(e) The ALJ may order witnesses excluded so that they cannot hear
the testimony of other witnesses, except that the ALJ may not order to
be excluded--
(1) A party who is a natural person;
(2) In the case of a party that is not a natural person, the officer
or employee of the party appearing for the entity pro se or designated
as the party's representative; or
(3) A natural person whose presence is shown by a party to be
essential to the presentation of its case, including a person engaged in
assisting the attorney for the Secretary.
Sec. 3.540 Evidence.
(a) The ALJ must determine the admissibility of evidence.
(b) Except as provided in this subpart, the ALJ is not bound by the
Federal Rules of Evidence. However, the ALJ may apply the Federal Rules
of Evidence where appropriate, for example, to exclude unreliable
evidence.
(c) The ALJ must exclude irrelevant or immaterial evidence.
(d) Although relevant, evidence may be excluded if its probative
value is substantially outweighed by the danger of unfair prejudice,
confusion of the issues, or by considerations of undue delay or needless
presentation of cumulative evidence.
(e) Although relevant, evidence must be excluded if it is privileged
under Federal law.
(f) Evidence concerning offers of compromise or settlement is
inadmissible to the extent provided in Rule 408 of the Federal Rules of
Evidence.
(g) Evidence of crimes, wrongs, or acts other than those at issue in
the instant case is admissible in order to show motive, opportunity,
intent, knowledge, preparation, identity, lack of mistake, or existence
of a scheme. This evidence is admissible regardless of whether the
crimes, wrongs, or acts occurred during the statute of limitations
period applicable to the acts or omissions that constitute the basis for
liability in the case and regardless of whether they were referenced in
the Secretary's notice of proposed determination under Sec. 3.420.
(h) The ALJ must permit the parties to introduce rebuttal witnesses
and evidence.
(i) All documents and other evidence offered or taken for the record
must be open to examination by both parties, unless otherwise ordered by
the ALJ for good cause shown.
[[Page 61]]
Sec. 3.542 The record.
(a) The hearing must be recorded and transcribed. Transcripts may be
obtained following the hearing from the ALJ. A party that requests a
transcript of hearing proceedings must pay the cost of preparing the
transcript unless, for good cause shown by the party, the payment is
waived by the ALJ or the Board, as appropriate.
(b) The transcript of the testimony, exhibits, and other evidence
admitted at the hearing, and all papers and requests filed in the
proceeding constitute the record for decision by the ALJ and the
Secretary.
(c) The record may be inspected and copied (upon payment of a
reasonable fee) by any person, unless otherwise ordered by the ALJ for
good cause shown, which may include the presence in the record of
identifiable patient safety work product.
(d) For good cause, which may include the presence in the record of
identifiable patient safety work product, the ALJ may order appropriate
redactions made to the record.
Sec. 3.544 Post hearing briefs.
The ALJ may require the parties to file post-hearing briefs. In any
event, any party may file a post-hearing brief. The ALJ must fix the
time for filing the briefs. The time for filing may not exceed 60 days
from the date the parties receive the transcript of the hearing or, if
applicable, the stipulated record. The briefs may be accompanied by
proposed findings of fact and conclusions of law. The ALJ may permit the
parties to file reply briefs.
Sec. 3.546 ALJ's decision.
(a) The ALJ must issue a decision, based only on the record, which
must contain findings of fact and conclusions of law.
(b) The ALJ may affirm, increase, or reduce the penalties imposed by
the Secretary.
(c) The ALJ must issue the decision to both parties within 60 days
after the time for submission of post-hearing briefs and reply briefs,
if permitted, has expired. If the ALJ fails to meet the deadline
contained in this paragraph, he or she must notify the parties of the
reason for the delay and set a new deadline.
(d) Unless the decision of the ALJ is timely appealed as provided
for in Sec. 3.548, the decision of the ALJ will be final and binding on
the parties 60 days from the date of service of the ALJ's decision.
Sec. 3.548 Appeal of the ALJ's decision.
(a) Any party may appeal the decision of the ALJ to the Board by
filing a notice of appeal with the Board within 30 days of the date of
service of the ALJ decision. The Board may extend the initial 30 day
period for a period of time not to exceed 30 days if a party files with
the Board a request for an extension within the initial 30 day period
and shows good cause.
(b) If a party files a timely notice of appeal with the Board, the
ALJ must forward the record of the proceeding to the Board.
(c) A notice of appeal must be accompanied by a written brief
specifying exceptions to the initial decision and reasons supporting the
exceptions. Any party may file a brief in opposition to the exceptions,
which may raise any relevant issue not addressed in the exceptions,
within 30 days of receiving the notice of appeal and the accompanying
brief. The Board may permit the parties to file reply briefs.
(d) There is no right to appear personally before the Board or to
appeal to the Board any interlocutory ruling by the ALJ.
(e) The Board may not consider any issue not raised in the parties'
briefs, nor any issue in the briefs that could have been raised before
the ALJ but was not.
(f) If any party demonstrates to the satisfaction of the Board that
additional evidence not presented at such hearing is relevant and
material and that there were reasonable grounds for the failure to
adduce such evidence at the hearing, the Board may remand the matter to
the ALJ for consideration of such additional evidence.
(g) The Board may decline to review the case, or may affirm,
increase, reduce, reverse or remand any penalty determined by the ALJ.
[[Page 62]]
(h) The standard of review on a disputed issue of fact is whether
the initial decision of the ALJ is supported by substantial evidence on
the whole record. The standard of review on a disputed issue of law is
whether the decision is erroneous.
(i) Within 60 days after the time for submission of briefs and reply
briefs, if permitted, has expired, the Board must serve on each party to
the appeal a copy of the Board's decision and a statement describing the
right of any respondent who is penalized to seek judicial review.
(j)(1) The Board's decision under paragraph (i) of this section,
including a decision to decline review of the initial decision, becomes
the final decision of the Secretary 60 days after the date of service of
the Board's decision, except with respect to a decision to remand to the
ALJ or if reconsideration is requested under this paragraph.
(2) The Board will reconsider its decision only if it determines
that the decision contains a clear error of fact or error of law. New
evidence will not be a basis for reconsideration unless the party
demonstrates that the evidence is newly discovered and was not
previously available.
(3) A party may file a motion for reconsideration with the Board
before the date the decision becomes final under paragraph (j)(1) of
this section. A motion for reconsideration must be accompanied by a
written brief specifying any alleged error of fact or law and, if the
party is relying on additional evidence, explaining why the evidence was
not previously available. Any party may file a brief in opposition
within 15 days of receiving the motion for reconsideration and the
accompanying brief unless this time limit is extended by the Board for
good cause shown. Reply briefs are not permitted.
(4) The Board must rule on the motion for reconsideration not later
than 30 days from the date the opposition brief is due. If the Board
denies the motion, the decision issued under paragraph (i) of this
section becomes the final decision of the Secretary on the date of
service of the ruling. If the Board grants the motion, the Board will
issue a reconsidered decision, after such procedures as the Board
determines necessary to address the effect of any error. The Board's
decision on reconsideration becomes the final decision of the Secretary
on the date of service of the decision, except with respect to a
decision to remand to the ALJ.
(5) If service of a ruling or decision issued under this section is
by mail, the date of service will be deemed to be 5 days from the date
of mailing.
(k)(1) A respondent's petition for judicial review must be filed
within 60 days of the date on which the decision of the Board becomes
the final decision of the Secretary under paragraph (j) of this section.
(2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for
judicial review filed in any U.S. Court of Appeals challenging the final
decision of the Secretary must be sent by certified mail, return receipt
requested, to the General Counsel of HHS. The petition copy must be a
copy showing that it has been time-stamped by the clerk of the court
when the original was filed with the court.
(3) If the General Counsel of HHS received two or more petitions
within 10 days after the final decision of the Secretary, the General
Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation
of any petitions that were received within the 10 day period.
Sec. 3.550 Stay of the Secretary's decision.
(a) Pending judicial review, the respondent may file a request for
stay of the effective date of any penalty with the ALJ. The request must
be accompanied by a copy of the notice of appeal filed with the Federal
court. The filing of the request automatically stays the effective date
of the penalty until such time as the ALJ rules upon the request.
(b) The ALJ may not grant a respondent's request for stay of any
penalty unless the respondent posts a bond or provides other adequate
security.
(c) The ALJ must rule upon a respondent's request for stay within 10
days of receipt.
Sec. 3.552 Harmless error.
No error in either the admission or the exclusion of evidence, and
no error or defect in any ruling or order or in
[[Page 63]]
any act done or omitted by the ALJ or by any of the parties is ground
for vacating, modifying or otherwise disturbing an otherwise appropriate
ruling or order or act, unless refusal to take such action appears to
the ALJ or the Board inconsistent with substantial justice. The ALJ and
the Board at every stage of the proceeding must disregard any error or
defect in the proceeding that does not affect the substantial rights of
the parties.
PART 4_NATIONAL LIBRARY OF MEDICINE--Table of Contents
Sec.
4.1 Programs to which these regulations apply.
4.2 Definitions.
4.3 Purpose of the Library.
4.4 Use of Library facilities.
4.5 Use of materials from the collections.
4.6 Reference, bibliographic, reproduction, and consultation services.
4.7 Fees.
4.8 Publication of the Library and information about the Library.
Authority: 42 U.S.C. 216, 286.
Source: 56 FR 29188, June 26, 1991, unless otherwise noted.
Sec. 4.1 Programs to which these regulations apply.
(a) The regulations of this part govern access to the National
Library of Medicine's facilities and library collections and the
availability of its bibliographic, reproduction, reference, and related
services. These functions are performed by the Library directly for the
benefit of the general public and health-sciences professionals as
required by sections 465(b) (3)-(6) of the Act (42 U.S.C. 286(b) (3)-
(6)).
(b) The regulations of this part do not apply to:
(1) The Library's internal functions relating to the acquisition and
preservation of materials and the organization of these materials as
required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1)
and (2)).
(2) The availability of ``records'' under the Freedom of Information
Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are
covered in 45 CFR parts 5 and 5b.
(3) Federal assistance for medical libraries and other purposes
which are authorized by sections 469-477 of the Act (42 U.S.C. 286b to
286b-8). (See parts 59a, 61 and 64 of this chapter.)
(4) The availability of facilities, collections, and related
services of Regional Medical Libraries established or maintained under
the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part
59a, subpart B of this chapter.)
Sec. 4.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
Collections means all books, periodicals, prints, audiovisual
materials, films, videotapes, recordings, manuscripts, and other
resource materials of the library. It does not include data processing
tapes or programs used solely for internal processing activities to
generate reference materials, nor does it include ``records'' of the
Library as defined in 45 CFR 5.5. Records of the Library are available
in accordance with the regulations under the Freedom of Information Act
and Privacy Act of 1974. (See 45 CFR parts 5 and 5b.)
Director means the Director of the National Library of Medicine or
the Director's delegate.
Health-sciences professional means any person engaged in: (1) The
administration of health activities; (2) the provision of health
services; or (3) research, teaching, or education concerned with the
advancement of medicine or other sciences related to health or
improvement of the public health.
Historical collection means: (1) Materials in the collections
published or printed prior to 1914; (2) manuscripts and prints; (3) the
archival film collection; and (4) other materials of the collections
which, because of age, or unique or unusual value, require special
handling, storage, or protection for their preservation, as determined
by the Director.
Library means the National Library of Medicine, established by
section 465 of the Act (42 U.S.C. 286).
Regional Medical Library means a medical library established or
maintained as a regional medical library under section 475 of the Act
(42 U.S.C. 286b-6).
[[Page 64]]
Sec. 4.3 Purpose of the Library.
The purpose of the Library is to assist the advancement of medical
and related sciences and aid the dissemination and exchange of
scientific and other information important to the progress of medicine
and the public health. The Library acquires and maintains library
materials pertinent to medicine, including audiovisual materials;
compiles, publishes, and disseminates catalogs, indices, and
bibliographies of these materials, as appropriate; makes available
materials, through loan or otherwise; provides reference and other
assistance to research; and engages in other activities in furtherance
of this purpose.
Sec. 4.4 Use of Library facilities.
(a) General. The Library facilities are available to any person
seeking to make use of the collections. The Director may prescribe
reasonable rules to assure the most effective use of facilities by
health-sciences professionals and to protect the collections from misuse
or damage. These rules must be consistent with the regulations in this
part and applicable Department regulations and policies on
nondiscrimination.
(b) Reading rooms. Public reading rooms are available for obtaining
and reading materials from the collections. The Director may prescribe
reasonable rules designed to provide adequate reading space and orderly
conditions and procedures.
(c) Study rooms. Upon request a limited number of study rooms may be
made available to individuals requiring extensive use of Library
materials. Requests for study rooms shall be addressed in writing to the
Director. The Director shall give priority, in the following order, for
study room use to:
(1) Persons engaged in ``special scientific projects'' under section
473 of the Act (42 U.S.C. 286b-4),
(2) Health-sciences professionals, and
(3) The general public.
Sec. 4.5 Use of materials from the collections.
(a) Unrestricted materials. Except as otherwise provided in this
section, materials from the collections are generally available to any
interested person only in facilities provided by the Library for this
purpose. The Director may prescribe additional reasonable rules to
assure the most effective use of the Library's resources by health-
sciences professionals and to protect the collections from misuse or
damage. The rules must be consistent with the regulations in this part
and applicable Department regulations and policies on nondiscrimination.
Materials in the collections are available upon each request which
assures, to the Director's satisfaction, that the materials will be
safeguarded from misuse, damage, loss, or misappropriation, and will be
returned promptly after use or upon request of the Library.
(b) Restricted materials--(1) Historical collection. Materials from
the historical collection are available only as the Director may permit
to assure their maximum preservation and protection. Copies of these
materials may be made available in the form of microfilm and other
copies, for which reasonable fees may be charged.
(2) Gifts. Materials in the collections are available only in
accordance with any limitations imposed as a condition of the
acquisition of those materials, whether the acquisition was by gift or
purchase.
(c) Loans--(1) General. Requests for loans of materials must assure
the Library that (i) the materials will be safeguarded from misuse,
damage, loss, or misappropriation and (ii) the materials will be
returned promptly after use or upon request of the Library. The Library
may provide copies in lieu of original materials, which need not be
returned unless otherwise stated at the time of the loan.
(2) Loans of audiovisual materials. Audiovisual materials are
available for loan under the same general terms as printed materials.
(3) Loans to other libraries. Upon request materials or copies are
available for use through libraries of public or private agencies or
institutions. The requesting library must assure that it has first
exhausted its own collection resources, those of other local libraries
in the geographic area, and those of the Regional Medical Library
network (including Regional and Resource Libraries) before making a
request for a loan.
[[Page 65]]
(4) Loans to health-sciences professionals. The Director may make
loans of materials directly to health-sciences professionals. An
individual wishing a loan of library materials must assure to the
satisfaction of the Director that the individual is geographically
isolated, in terms of distance or available transportation, from medical
literature resources likely to contain the desired material.
(Approved by the Office of Management and Budget under control number
0925-0276)
Sec. 4.6 Reference, bibliographic, reproduction, and consultation services.
(a) General. To the extent resources permit, the Library will make
available, upon request, reference, bibliographic, reproduction, and
consultation services. Priority will be given to requests from health-
sciences professionals for services not reasonably available through
local or regional libraries.
(b) Specialized bibliographic services. The Director may provide
bibliographies on individually selected medical or scientific topics
upon request where it is consistent with the Library's purpose. The
Director may publish and make available for general distribution by the
Library, bibliographic searches determined to be of general interest.
The Library may also produce and distribute a limited number of
bibliographies on topics of general interest to public or nonprofit
health-related professional societies, research organizations, and other
group users. These bibliographies may be produced on a regularly
recurring or intermittent basis under contract between the Library and
public or nonprofit agencies, when determined in each case by the
Director to be necessary to assure more effective distribution of the
bibliographic information.
(c) Information retrieval system computer tapes. To the extent
Library resources permit and in order to further the Library's purpose,
the Director may make available upon request by agencies, organizations,
and institutions copies of all or part of the Library's magnetic tapes.
Sec. 4.7 Fees.
The Director may charge reasonable fees for any service provided by
the Library under this part, in accordance with a schedule available at
the Library upon request, which are designed to recover all or a portion
of the cost to the Library of providing the service.
Sec. 4.8 Publication of the Library and information about the Library.
Lists of bibliographies, Library publications sold by the Government
Printing Office, necessary application forms, and other information
concerning the organization, operation, functions, and services of the
Library, are available from the National Library of Medicine, Bethesda,
Maryland 20894.
PART 5_DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS--
Table of Contents
Sec.
5.1 Purpose.
5.2 Definitions.
5.3 Procedures for designation of health professional(s) shortage areas.
5.4 Notification and publication of designations and withdrawals.
Appendix A to Part 5--Criteria for Designation of Areas having Shortages
of Primary Medical Care Professional(s)
Appendix B to Part 5--Criteria for Designation of Areas having Shortages
of Dental Professional(s)
Appendix C to Part 5--Criteria for Designation of Areas Having Shortages
of Mental Health Professionals
Appendix D to Part 5--Criteria for Designation of Areas having Shortages
of Vision Care Professional(s)
Appendix E to Part 5--Criteria for Designation of Areas having Shortages
of Podiatric Professional(s)
Appendix F to Part 5--Criteria for Designation of Areas having Shortages
of Pharmacy Professional(s)
Appendix G to Part 5--Criteria for Designation of Areas having Shortages
of Veterinary Professional(s)
Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690
(42 U.S.C. 216); sec. 332 of the Public Health Service Act, 90 Stat.
2270-2272 (42 U.S.C. 254e).
Source: 45 FR 76000, Nov. 17, 1980, unless otherwise noted.
[[Page 66]]
Sec. 5.1 Purpose.
These regulations establish criteria and procedures for the
designation of geographic areas, population groups, medical facilities,
and other public facilities, in the States, as health professional(s)
shortage areas.
Sec. 5.2 Definitions.
Act means the Public Health Service Act, as amended.
Health professional(s) shortage area means any of the following
which the Secretary determines has a shortage of health professional(s):
(1) 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); (2) a population group; or (3) a
public or nonprofit private medical facility.
Health service area means a health service area whose boundaries
have been designated by the Secretary, under section 1511 of the Act,
for purposes of health planning activities.
Health systems agency or HSA means the health systems agency
designated, under section 1515 of the Act, to carry out health planning
activities for a specific health service area.
Medical facility means a facility for the delivery of health
services and includes: (1) A community health center, public health
center, outpatient medical facility, or community mental health center;
(2) a hospital, State mental hospital, facility for long-term care, or
rehabilitation facility; (3) a migrant health center or an Indian Health
service facility; (4) a facility for delivery of health services to
inmates in a U.S. penal or correctional institution (under section 323
of the Act) or a State correctional institution; (5) a Public Health
Service medical facility (used in connection with the delivery of health
services under section 320, 321, 322, 324, 325, or 326 of the Act); or
(6) any other Federal medical facility.
Metropolitan area means an area which has been designated by the
Office of Management and Budget as a standard metropolitan statistical
area (SMSA). All other areas are ``non-metropolitan areas.''
Poverty level means the povery level as defined by the Bureau of the
Census, using the poverty index adopted by a Federal Interagency
Committee in 1969, and updated each year to reflect changes in the
Consumer Price Index.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department to whom the authority
involved has been delegated.
State includes, in addition to the several States, the District of
Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands,
the Virgin Islands, Guam, American Samoa, and the Trust Territory of the
Pacific Islands.
State health planning and development agency or SHPDA means a State
health planning and development agency designated under section 1521 of
the Act.
Sec. 5.3 Procedures for designation of health professional(s)
shortage areas.
(a) Using data available to the Department from national, State, and
local sources and based upon the criteria in the appendices to this
part, the Department will annually prepare listings (by State and health
service area) of currently designated health professional(s) shortage
areas and potentially designatable areas, together with appropriate
related data available to the Department. Relevant portions of this
material will then be forwarded to each health systems agency, State
health planning and development agency, and Governor, who will be asked
to review the listings for their State, correct any errors of which they
are aware, and offer their recommendations, if any, within 90 days, as
to which geographic areas, population groups, and facilities in areas
under their jurisdiction should be designated. An information copy of
these listings will also be made available, upon request, to interested
parties for their use in providing comments or recommendations to the
Secretary and/or to the appropriate HSA, SHPDA, or Governor.
(b) In addition, any agency or individual may request the Secretary
to designate (or withdraw the designation of) a particular geographic
area, population group, or facility as a health
[[Page 67]]
professional(s) shortage area. Each request will be forwarded by the
Secretary to the appropriate HSA, SHPDA, and Governor, who will be asked
to review it and offer their recommendations, if any, within 30 days. An
information copy will also be made available to other interested
parties, upon request, for their use in providing comments or
recommendations to the Secretary and/or to the appropriate HSA, SHPDA,
or Governor.
(c) In each case where the designation of a public facility
(including a Federal medical facility) is under consideration, the
Secretary will give written notice of the proposed designation to the
chief administrative officer of the facility, who will be asked to
review it and offer their recommendations, if any, within 30 days.
(d) After review of the available information and consideration of
the comments and recommendations submitted, the Secretary will designate
health professional(s) shortage areas and withdraw the designation of
any areas which have been determined no longer to have a shortage of
health professional(s).
Sec. 5.4 Notification and publication of designations and withdrawals.
(a) The Secretary will give written notice of the designation (or
withdrawal of designation) of a health professional(s) shortage area,
not later than 60 days from the date of the designation (or withdrawal
of 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
in part located;
(2) Each HSA for a health service area which includes all or any
part of the area, population group, medical facility, or other public
facility so designated;
(3) The SHPDA for each State in which the area, population group,
medical facility, or other public facility so designated is in whole or
in part located; and
(4) Appropriate public or nonprofit private entities which are
located in or which have a demonstrated interest in the area so
designated.
(b) The Secretary will periodically publish updated lists of
designated health professional(s) shortage areas in the Federal
Register, by type of professional(s) shortage. An updated list of areas
for each type of professional(s) shortage will be published at least
once annually.
(c) The effective date of the designation of an area shall be the
date of the notification letter to the individual or agency which
requested the designation, or the date of publication in the Federal
Register, whichever comes first.
(d) Once an area is listed in the Federal Register as a designated
health professional(s) shortage area, the effective date of any later
withdrawal of the area's designation shall be the date when notification
of the withdrawal, or an updated list of designated areas which does not
include it, is published in the Federal Register.
Sec. Appendix A to Part 5--Criteria for Designation of Areas Having
Shortages of Primary Medical Care Professional(s)
Part I--Geographic Areas
A. Federal and State Correctional Institutions.
1. Criteria.
Medium to maximum security Federal and State correctional
institutions and youth detention facilities will be designated as having
a shortage of primary medical care professional(s) if both the following
criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of
FTE primary care physicians serving the institution is at least 1,000:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate
that intake medical examinations are routinely performed upon entry,
then--Number of internees=average number of inmates.
(ii) If the average length-of-stay is specified as one year or more,
and intake medical examinations are routinely performed upon entry,
then--Number of internees=average number of inmates+(0.3)xnumber of new
inmates per year.
[[Page 68]]
(iii) If the average length-of-stay is specified as less than one
year, and intake examinations are routinely performed upon entry, then--
Number of internees=average number of inmates+(0.2)x(1+ALOS/2)xnumber of
new inmates per year where ALOS=average length-of-stay (in fraction of
year). (The number of FTE primary care physicians is computed as in part
I, section B, paragraph 3 above.)
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of
internees to primary care physicians, as follows:
Group 1--Institutions with 500 or more inmates and no physicians.
Group 2--Other institutions with no physicians and institutions with
R greater than (or equal to) 2,000:1.
Group 3--Institutions with R greater than (or equal to) 1,000:1 but
less than 2,000:1.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Primary Medical Care Services.
(a) The following areas will be considered rational areas for the
delivery of primary medical care services:
(i) A county, or a group of contiguous counties whose population
centers are within 30 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more
than one county, whose population, because of topography, market or
transportation patterns, distinctive population characteristics or other
factors, has limited access to contiguous area resources, as measured
generally by a travel time greater than 30 minutes to such resources.
(iii) Established neighborhoods and communities within metropolitan
areas which display a strong self-identity (as indicated by a
homogeneous socioeconomic or demographic structure and/or a tradition of
interaction or interdependency), have limited interaction with
contiguous areas, and which, in general, have a minimum population of
20,000.
(b) The following distances will be used as guidelines in
determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways:
25 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the distance
corresponding to 30 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident
civilian population of the area, excluding inmates of institutions, with
the following adjustments, where appropriate:
(a) Adjustments to the population for the differing health service
requirements of various age-sex population groups will be computed using
the table below of visit rates for 12 age-sex population cohorts. The
total expected visit rate will first be obtained by multiplying each of
the 12 visit rates in the table by the size of the area population
within that particular age-sex cohort and adding the resultant 12 visit
figures together. This total expected visit rate will then be divided by
the U.S. average per capita visit rate of 5.1, to obtain the adjusted
population for the area.
----------------------------------------------------------------------------------------------------------------
Age groups
-----------------------------------------------
Sex Under 65 and
5 5-14 15-24 25-44 45-64 over
----------------------------------------------------------------------------------------------------------------
Male............................................................ 7.3 3.6 3.3 3.6 4.7 6.4
Female.......................................................... 6.4 3.2 5.5 6.4 6.5 6.8
----------------------------------------------------------------------------------------------------------------
(b) The effect of transient populations on the need of an area for
primary care professional(s) will be taken into account as follows:
(i) Seasonal residents, i.e., those who maintain a residence in the
area but inhabit it for only 2 to 8 months per year, may be included but
must be weighted in proportion to the fraction of the year they are
present in the area.
(ii) Other tourists (non-resident) may be included in an area's
population but only with a weight of 0.25, using the following formula:
Effective tourist contribution to population=0.25x(fraction of year
tourists are present in area)x(average daily number of tourists during
portion of year that tourists are present).
(iii) Migratory workers and their families may be included in an
area's population, using the following formula: Effective migrant
contribution to population=(fraction of year migrants are present in
area)x(average daily number of migrants during portion of year that
migrants are present).
3. Counting of Primary Care Practitioners.
(a) All non-Federal doctors of medicine (M.D.) and doctors of
osteopathy (D.O.) providing direct patient care who practice principally
in one of the four primary care specialities--general or family
practice, general internal medicine, pediatrics, and obstetrics
[[Page 69]]
and gynecology--will be counted. Those physicians engaged solely in
administration, research, and teaching will be excluded. Adjustments for
the following factors will be made in computing the number of full-time-
equivalent (FTE) primary care physicians:
(i) Interns and residents will be counted as 0.1 full-time
equivalent (FTE) physicians.
(ii) Graduates of foreign medical schools who are not citizens or
lawful permanent residents of the United States will be excluded from
physician counts.
(iii) Those graduates of foreign medical schools who are citizens or
lawful permanent residents of the United States, but do not have
unrestricted licenses to practice medicine, will be counted as 0.5 FTE
physicians.
(b) Practitioners who are semi-retired, who operate a reduced
practice due to infirmity or other limiting conditions, or who provide
patient care services to the residents of the area only on a part-time
basis will be discounted through the use of full-time equivalency
figures. A 40-hour work week will be used as the standard for
determining full-time equivalents in these cases. For practitioners
working less than a 40-hour week, every four (4) hours (or \1/2\ day)
spent providing patient care, in either ambulatory or inpatient
settings, will be counted as 0.1 FTE (with numbers obtained for FTE's
rounded to the nearest 0.1 FTE), and each physician providing patient
care 40 or more hours a week will be counted as 1.0 FTE physician. (For
cases where data are available only for the number of hours providing
patient care in office settings, equivalencies will be provided in
guidelines.)
(c) In some cases, physicians located within an area may not be
accessible to the population of the area under consideration. Allowances
for physicians with restricted practices can be made, on a case-by-case
basis. However, where only a portion of the population of the area
cannot access existing primary care resources in the area, a population
group designation may be more appropriate (see part II of this
appendix).
(d) Hospital staff physicians involved exclusively in inpatient care
will be excluded. The number of full-time equivalent physicians
practicing in organized outpatient departments and primary care clinics
will be included, but those in emergency rooms will be excluded.
(e) Physicians who are suspended under provisions of the Medicare-
Medicaid Anti-Fraud and Abuse Act for a period of eighteen months or
more will be excluded.
4. Determination of Unusually High Needs for Primary Medical Care
Services.
An area will be considered as having unusually high needs for
primary health care services if at least one of the following criteria
is met:
(a) The area has more than 100 births per year per 1,000 women aged
15-44.
(b) The area has more than 20 infant deaths per 1,000 live births.
(c) More than 20% of the population (or of all households) have
incomes below the poverty level.
5. Determination of Insufficient Capacity of Existing Primary Care
Providers.
An area's existing primary care providers will be considered to have
insufficient capacity if at least two of the following criteria are met:
(a) More than 8,000 office or outpatient visits per year per FTE
primary care physician serving the area.
(b) Unusually long waits for appointments for routine medical
services (i.e., more than 7 days for established patients and 14 days
for new patients).
(c) Excessive average waiting time at primary care providers (longer
than one hour where patients have appointments or two hours where
patients are treated on a first-come, first-served basis).
(d) Evidence of excessive use of emergency room facilities for
routine primary care.
(e) A substantial proportion (2/3 or more) of the area's physicians
do not accept new patients.
(f) Abnormally low utilization of health services, as indicated by
an average of 2.0 or less office visits per year on the part of the
area's population.
6. Contiguous Area Considerations.
Primary care professional(s) in areas contiguous to an area being
considered for designation will be considered excessively distant,
overutilized or inaccessible to the population of the area under
consideration if one of the following conditions prevails in each
contiguous area:
(a) Primary care professional(s) in the contiguous area are more
than 30 minutes travel time from the population center(s) of the area
being considered for designation (measured in accordance with paragraph
B.1(b) of this part).
(b) The contiguous area population-to-full-time-equivalent primary
care physician ratio is in excess of 2000:1, indicating that
practitioners in the contiguous area cannot be expected to help
alleviate the shortage situation in the area being considered for
designation.
(c) Primary care professional(s) in the contiguous area are
inaccessible to the population of the area under consideration because
of specified access barriers, such as:
(i) Significant differences between the demographic (or socio-
economic) characteristics of the area under consideration and those of
the contiguous area, indicating that the population of the area under
consideration may be effectively isolated from nearby resources. This
isolation could be indicated, for example, by an unusually high
proportion of non-English-speaking persons.
[[Page 70]]
(ii) A lack of economic access to contiguous area resources, as
indicated particularly where a very high proportion of the population of
the area under consideration is poor (i.e., where more than 20 percent
of the population or the households have incomes below the poverty
level), and Medicaid-covered or public primary care services are not
available in the contiguous area.
C. Determination of Degree of Shortage.
Designated areas will be assigned to degree-of-shortage groups,
based on the ratio (R) of population to number of full-time equivalent
primary care physicians and the presence or absence of unusually high
needs for primary health care services, according to the following
table:
------------------------------------------------------------------------
High needs not High needs
indicated indicated
------------------------------------------------------------------------
Group 1......................... No physicians..... No physicians; or
R=5,00
0
Group 2......................... R=5,000 5,000R<
l=4,000
Group 3......................... 5,000R< 4,000R<
l=4,000. l=3,500
Group 4......................... 4,000R< 3,500R<
l=3,500. l=3,000
------------------------------------------------------------------------
D. Determination of size of primary care physician shortage. Size of
Shortage (in number of FTE primary care physicians needed) will be
computed using the following formulas:
(1) For areas without unusually high need or insufficient capacity:
Primary care physician shortage = area population / 3,500 - number of
FTE primary care physicians
(2) For areas with unusually high need or insufficient capacity:
Primary care physician shortage = area population / 3,000 - number of
FTE primary care physicians
Part II--Population Groups
A. Criteria.
1. In general, specific population groups within particular
geographic areas will be designated as having a shortage of primary
medical care professional(s) if the following three criteria are met:
(a) The area in which they reside is rational for the delivery of
primary medical care services, as defined in paragraph B.1 of part I of
this appendix.
(b) Access barriers prevent the population group from use of the
area's primary medical care providers. Such barriers may be economic,
linguistic, cultural, or architectural, or could involve refusal of some
providers to accept certain types of patients or to accept Medicaid
reimbursement.
(c) The ratio of the number of persons in the population group to
the number of primary care physicians practicing in the area and serving
the population group is at least 3,000:1.
2. Indians and Alaska Natives will be considered for designation as
having shortages of primary care professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d)
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are
automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section
4(c) of Pub. L. 94-437) will be designated if the general criteria in
paragraph A are met.
B. Determination of Degree of Shortage.
Each designated population group will be assigned to a degree-of-
shortage group, based on the ratio (R) of the group's population to the
number of primary care physicians serving it, as follows:
Group 1--No physicians or R5,000.
Group 2--5,000R=4,000.
Group 3--4,000R=3,500.
Group 4--3,500R=3,000.
Population groups which have received ``automatic'' designation will
be assigned to degree-of-shortage group 4 if no information on the ratio
of the number of persons in the group to the number of FTE primary care
physicians serving them is provided.
C. Determination of size of primary care physician shortage. Size of
shortage (in number of primary care physicians needed) will be computed
as follows:
Primary care physician shortage=number of persons in population
group/3,000-number of FTE primary care physicians
Part III--Facilities
A. Federal and State Correctional Institutions.
1. Criteria.
Medium to maximum security Federal and State correctional
institutions and youth detention facilities will be designated as having
a shortage of primary medical care professional(s) if both the following
criteria are met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of
FTE primary care physicians serving the institution is at least 1,000:1.
(Here the number of internees is the number of inmates present at the
beginning of the year plus the number of new inmates entering the
institution during the year, including those who left before the end of
the year; the number of FTE primary care physicians is computed as in
part I, section B, paragraph 3 above.)
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of
internees to primary care physicians, as follows:
Group 1--Institutions with 500 or more inmates and no physicians.
Group 2--Other institutions with no physicians and institutions with
R=2,000.
[[Page 71]]
Group 3--Institutions with 2,000R=1,000.
B. Public or Non-Profit Medical Facilities.
1. Criteria.
Public or non-profit private medical facilities will be designated
as having a shortage of primary medical care professional(s) if:
(a) the facility is providing primary medical care services to an
area or population group designated as having a primary care
professional(s) shortage; and
(b) the facility has insufficient capacity to meet the primary care
needs of that area or population group.
2. Methodology
In determining whether public or nonprofit private medical
facilities meet the criteria established by paragraph B.1 of this Part,
the following methodology will be used:
(a) Provision of Services to a Designated Area or Population Group.
A facility will be considered to be providing services to a
designated area or population group if either:
(i) A majority of the facility's primary care services are being
provided to residents of designated primary care professional(s)
shortage areas or to population groups designated as having a shortage
of primary care professional(s); or
(ii) The population within a designated primary care shortage area
or population group has reasonable access to primary care services
provided at the facility. Reasonable access will be assumed if the area
within which the population resides lies within 30 minutes travel time
of the facility and non-physical barriers (relating to demographic and
socioeconomic characteristics of the population) do not prevent the
population from receiving care at the facility.
Migrant health centers (as defined in section 319(a)(1) of the Act)
which are located in areas with designated migrant population groups and
Indian Health Service facilities are assumed to be meeting this
requirement.
(b) Insufficient capacity to meet primary care needs.
A facility will be considered to have insufficient capacity to meet
the primary care needs of the area or population it serves if at least
two of the following conditions exist at the facility:
(i) There are more than 8,000 outpatient visits per year per FTE
primary care physician on the staff of the facility. (Here the number of
FTE primary care physicians is computed as in Part I, Section B,
paragraph 3 above.)
(ii) There is excessive usage of emergency room facilities for
routine primary care.
(iii) Waiting time for appointments is more than 7 days for
established patients or more than 14 days for new patients, for routine
health services.
(iv) Waiting time at the facility is longer than 1 hour where
patients have appointments or 2 hours where patients are treated on a
first-come, first-served basis.
3. Determination of Degree of Shortage.
Each designated medical facility will be assigned to the same
degree-of-shortage group as the designated area or population group
which it serves.
[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8737, Mar. 2, 1989; 57
FR 2480, Jan. 22, 1992]
Sec. Appendix B to Part 5--Criteria for Designation of Areas Having
Shortages of Dental Professional(s)
Part I--Geographic Areas
A. Federal and State Correctional Institutions.
1. Criteria
Medium to maximum security Federal and State correctional
institutions and youth detention facilities will be designated as having
a shortage of dental professional(s) if both the following criteria are
met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of
FTE dentists serving the institution is at least 1,500:1.
Here the number of internees is defined as follows:
(i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate
that intake dental examinations are routinely performed by dentists upon
entry, then--Number of internees=average number of inmates.
(ii) If the average length-of-stay is specified as one year or more,
and intake dental examinations are routinely performed upon entry,
then--Number of internees=average number of inmates+number of new
inmates per year.
(iii) If the average length-of-stay is specified as less than one
year, and intake dental examinations are routinely performed upon entry,
then--Number of internees=average number of inmates+\1/
3\x(1+2xALOS)xnumber of new inmates per year where ALOS=average length-
of-stay (in fraction of year).
(The number of FTE dentists is computed as in part I, section B,
paragraph 3 above.)
2. Determination of Degree of Shortage.
Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of
internees to dentists, as follows:
Group 1--Institutions with 500 or more inmates and no dentists.
Group 2--Other institutions with no dentists and institutions with R
greater than (or equal to) 3,000:1.
[[Page 72]]
Group 3--Institutions with R greater than (or equal to) 1,500:1 but
less than 3,000:1.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this part, the following methodology will be used:
1. Rational Area for the Delivery of Dental Services.
(a) The following areas will be considered rational areas for the
delivery of dental health services:
(i) A county, or a group of several contiguous counties whose
population centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more
than one county) whose population, because of topography, market or
transportation patterns, distinctive population characteristics, or
other factors, has limited access to contiguous area resources, as
measured generally by a travel time of greater than 40 minutes to such
resources.
(iii) Established neighborhoods and communities within metropolitan
areas which display a strong self-identity (as indicated by a homogenous
socioeconomic or demographic structure and/or a traditional of
interaction or intradependency), have limited interaction with
contiguous areas, and which, in general, have a minimum population of
20,000.
(b) The following distances will be used as guidelines in
determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways:
30 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the distance
corresponding to 40 minutes travel time.
2. Population Count.
The population count use will be the total permanent resident
civilian population of the area, excluding inmates of institutions, with
the following adjustments:
(a) Seasonal residents, i.e., those who maintain a residence in the
area but inhabit it for only 2 to 8 months per year, may be included but
must be weighted in proportion to the fraction of the year they are
present in the area.
(b) Migratory workers and their families may be included in an
area's population using the following formula: Effective migrant
contribution to population=(fraction of year migrants are present in
area)x(average daily number of migrants during portion of year that
migrants are present).
3. Counting of Dental Practitioners.
(a) All non-Federal dentists providing patient care will be counted,
except in those areas where it is shown that specialists (those dentists
not in general practice or pedodontics) are serving a larger area and
are not addressing the general dental care needs of the area under
consideration.
(b) Full-time equivalent (FTE) figures will be used to reflect
productivity differences among dental practices based on the age of the
dentists, the number of auxiliaries employed, and the number of hours
worked per week. In general, the number of FTE dentists will be computed
using weights obtained from the matrix in Table 1, which is based on the
productivity of dentists at various ages, with different numbers of
auxiliaries, as compared with the average productivity of all dentists.
For the purposes of these determinations, an auxiliary is defined as any
non-dentist staff employed by the dentist to assist in operation of the
practice.
Table 1--Equivalency Weights, by Age and Number of Auxiliaries
------------------------------------------------------------------------
<55 55-59 60-64 65+
------------------------------------------------------------------------
No auxiliaries.......................... 0.8 0.7 0.6 0.5
One auxiliary........................... 1.0 0.9 0.8 0.7
Two auxiliaries......................... 1.2 1.0 1.0 0.8
Three auxiliaries....................... 1.4 1.2 1.0 1.0
Four or more auxiliaries................ 1.5 1.5 1.3 1.2
------------------------------------------------------------------------
If information on the number of auxiliaries employed by the dentist
is not available, Table 2 will be used to compute the number of full-
time equivalent dentists.
Table 2--Equivalency Weights, by Age
------------------------------------------------------------------------
55 55-59 60-64 65+
------------------------------------------------------------------------
Equivalency weights..................... 1.2 0.9 0.8 0.6
------------------------------------------------------------------------
The number of FTE dentists within a particular age group (or age/
auxiliary group) will be obtained by multiplying the number of dentists
within that group by its corresponding equivalency weight. The total
supply of FTE dentists within an area is then computed as the sum of
those dentists within each age (or age/auxiliary) group.
(c) The equivalency weights specified in tables 1 and 2 assume that
dentists within a particular group are working full-time (40 hours per
week). Where appropriate data are available, adjusted equivalency
figures for dentists who are semi-retired, who operate a reduced
practice due to infirmity or other limiting conditions, or who are
available to the population of an area only on a part-time basis will be
used to reflect the reduced availability of these dentists. In computing
these equivalency figures, every 4 hours (or \1/2\ day) spent in the
dental practice will be counted as 0.1 FTE except that each dentist
working more than 40 hours a week will be
[[Page 73]]
counted as 1.0. The count obtained for a particular age group of
dentists will then be multiplied by the appropriate equivalency weight
from table 1 or 2 to obtain a full-time equivalent figure for dentists
within that particular age or age/auxiliary category.
4. Determination of Unusually High Needs for Dental Services.
An area will be considered as having unusually high needs for dental
services if at least one of the following criteria is met:
(a) More than 20% of the population (or of all households) has
incomes below the poverty level.
(b) The majority of the area's population does not have a
fluoridated water supply.
5. Determination of Insufficient Capacity of Existing Dental Care
Providers.
An area's existing dental care providers will be considered to have
insufficient capacity if at least two of the following criteria are met:
(a) More than 5,000 visits per year per FTE dentist serving the
area.
(b) Unusually long waits for appointments for routine dental
services (i.e., more than 6 weeks).
(c) A substantial proportion (\2/3\ or more) of the area's dentists
do not accept new patients.
6. Contiguous Area Considerations.
Dental professional(s) in areas contiguous to an area being
considered for designation will be considered excessively distant,
overutilized or inaccessible to the population of the area under
consideration if one of the following conditions prevails in each
contiguous area:
(a) Dental professional(s) in the contiguous area are more than 40
minutes travel time from the center of the area being considered for
designation (measured in accordance with Paragraph B.1.(b) of this
part).
(b) Contiguous area population-to-(FTE) dentist ratios are in excess
of 3,000:1, indicating that resources in contiguous areas cannot be
expected to help alleviate the shortage situation in the area being
considered for designation.
(c) Dental professional(s) in the contiguous area are inaccessible
to the population of the area under consideration because of specified
access barriers, such as:
(i) Significant differences between the demographic (or
socioeconomic) characteristics of the area under consideration and those
of the contiguous area, indicating that the population of the area under
consideration may be effectively isolated from nearby resources. Such
isolation could be indicated, for example, by an unusually high
proportion of non-English-speaking persons.
(ii) A lack of economic access to contiguous area resources,
particularly where a very high proportion of the population of the area
under consideration is poor (i.e., where more than 20 percent of the
population or of the households have incomes below the poverty level)
and Medicaid-covered or public dental services are not available in the
contiguous area.
C. Determination of Degree of Shortage.
The degree of shortage of a given geographic area, designated as
having a shortage of dental professional(s), will be determined using
the following procedure:
Designated areas will be assigned to degree-of-shortage groups,
based on the ratio (R) of population to number of full-time-equivalent
dentists and the presence or absence of unusually high needs for dental
services, or insufficient capacity of existing dental care providers
according to the following table:
------------------------------------------------------------------------
High needs or
insufficient High needs or
capacity not insufficient
indicated capacity indicated
------------------------------------------------------------------------
Group 1......................... No dentists....... No dentists or
R=8,00
0.
Group 2......................... R=8,000 8,000R<
l=6,000.
Group 3......................... 8,000R< 6,000R<
l=6,000. l=5,000.
Group 4......................... 6,000R< 5,000R<
l=5,000. l=4,000.
------------------------------------------------------------------------
D. Determination of size of dental shortage. Size of Dental Shortage
(in number of FTE dental practitioners needed) will be computed using
the following formulas:
(1) For areas without unusually high need:
Dental shortage=area population/5,000-number of FTE dental practitioners
(2) For areas with unusually high need:
Dental shortage=area population/4,000-number of FTE dental practitioners
Part II--Population Groups
A. Criteria.
1. In general, specified population groups within particular
geographic areas will be designated as having a shortage of dental care
professional(s) if the following three criteria are met:
a. The area in which they reside is rational for the delivery of
dental care services, as defined in paragraph B.1 of part I of this
appendix.
b. Access barriers prevent the population group from use of the
area's dental providers.
c. The ratio (R) of the number of persons in the population group to
the number of dentists practicing in the area and serving the population
group is at least 4,000:1.
2. Indians and Alaska Natives will be considered for designation as
having shortages of dental professional(s) as follows:
(a) Groups of members of Indian tribes (as defined in section 4(d)
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are
automatically designated.
(b) Other groups of Indians or Alaska Natives (as defined in section
4(c) of Pub. L. 94-437) will be designated if the general criteria in
paragraph 1 are met.
[[Page 74]]
B. Determination of Degree of Shortage.
Each designated population group will be assigned to a degree-of-
shortage group as follows:
Group 1--No dentists or R=8,000.
Group 2--8,000R=6,000.
Group 3--6,000R=5,000.
Group 4--5,000R=4,000.
Population groups which have received ``automatic'' designation will be
assigned to degree-of-shortage group 4 unless information on the ratio
of the number of persons in the group to the number of FTE dentists
serving them is provided.
C. Determination of size of dental shortage. Size of dental shortage
will be computed as follows:
Dental shortage=number of persons in population group/4,000-number of
FTE dental practitioners
Part III--Facilities
A. Federal and State Correctional Institutions.
1. Criteria.
Medium to maximum security Federal and State correctional
institutions and youth detention facilities will be designated as having
a shortage of dental professional(s) if both the following criteria are
met:
(a) The institution has at least 250 inmates.
(b) The ratio of the number of internees per year to the number of
FTE dentists serving the institution is at least 1,500:1. (Here the
number of internees is the number of inmates present at the beginning of
the year plus the number of new inmates entering the institution during
the year, including those who left before the end of the year; the
number of FTE dentists is computed as in part I, section B, paragraph 3
above.)
2. Determination of Degree-of-Shortage.
Designated correctional institutions will be assigned to degree-of-
shortage groups as follows, based on number of inmates and/or the ratio
(R) of internees to dentists:
Group 1--Institutions with 500 or more inmates and no dentists.
Group 2--Other institutions with no dentists and institutions with R
3,000.
Group 3--Institutions with 3,000 R 1,500.
B. Public or Non-Profit Private Dental Facilities.
1. Criteria.
Public or nonprofit private facilties providing general dental care
services will be designated as having a shortage of dental
professional(s) if both of the following criteria are met:
(a) The facility is providing general dental care services to an
area or population group designated as having a dental professional(s)
shortage; and
(b) The facility has insufficent capacity to meet the dental care
needs of that area or population group.
2. Methodology.
In determining whether public or nonprofit private facilities meet
the criteria established by paragraph B.1. of this part, the following
methodology will be used:
(a) Provision of Services to a Designated Area or Population Group.
A facility will be considered to be providing services to an area or
population group if either:
(i) A majority of the facility's dental care services are being
provided to residents of designated dental professional(s) shortage
areas or to population groups designated as having a shortage of dental
professional(s); or
(ii) The population within a designated dental shortage area or
population group has reasonable access to dental services provided at
the facility. Reasonable access will be assumed if the population lies
within 40 minutes travel time of the facility and non-physical barriers
(relating to demographic and socioeconomic characteristics of the
population) do not prevent the population from receiving care at the
facility.
Migrant health centers (as defined in section 319(a)(1) of the Act)
which are located in areas with designated migrant population groups and
Indian Health Service facilities are assumed to be meeting this
requirement.
(b) Insufficient Capacity To Meet Dental Care Needs.
A facility will be considered to have insufficient capacity to meet
the dental care needs of a designated area or population group if either
of the following conditions exists at the facility.
(i) There are more than 5,000 outpatient visits per year per FTE
dentist on the staff of the facility. (Here the number of FTE dentists
is computed as in part I, section B, paragraph 3 above.)
(ii) Waiting time for appointments is more than 6 weeks for routine
dental services.
3. Determination of Degree of Shortage.
Each designated dental facility will be assigned to the same degree-
of-shortage group as the designated area or population group which it
serves.
[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57
FR 2480, Jan. 22, 1992]
Sec. Appendix C to Part 5--Criteria for Designation of Areas Having
Shortages of Mental Health Professionals
Part I--Geographic Areas
A. Criteria. A geographic area will be designated as having a
shortage of mental health professionals if the following four criteria
are met:
[[Page 75]]
1. The area is a rational area for the delivery of mental health
services.
2. One of the following conditions prevails within the area:
(a) The area has--
(i) A population-to-core-mental-health-professional ratio greater
than or equal to 6,000:1 and a population-to-psychiatrist ratio greater
than or equal to 20,000:1, or
(ii) A population-to-core-professional ratio greater than or equal
to 9,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to
30,000:1;
(b) The area has unusually high needs for mental health services,
and has--
(i) A population-to-core-mental-health-professional ratio greater
than or equal to 4,500:1 and
A population-to-psychiatrist ratio greater than or equal to
15,000:1, or
(ii) A population-to-core-professional ratio greater than or equal
to 6,000:1, or
(iii) A population-to-psychiatrist ratio greater than or equal to
20,000:1;
3. Mental health professionals in contiguous areas are overutilized,
excessively distant or inaccessible to residents of the area under
consideration.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Mental Health Services.
(a) The following areas will be considered rational areas for the
delivery of mental health services:
(i) An established mental health catchment area, as designated in
the State Mental Health Plan under the general criteria set forth in
section 238 of the Community Mental Health Centers Act.
(ii) A portion of an established mental health catchment area whose
population, because of topography, market and/or transportation patterns
or other factors, has limited access to mental health resources in the
rest of the catchment area, as measured generally by a travel time of
greater than 40 minutes to these resources.
(iii) A county or metropolitan area which contains more than one
mental health catchment area, where data are unavailable by individual
catchment area.
(b) The following distances will be used as guidelines in
determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways:
30 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the distance
corresponding to 40 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident
civilian population of the area, excluding inmates of institutions.
3. Counting of mental health professionals. (a) All non-Federal core
mental health professionals (as defined below) providing mental health
patient care (direct or other, including consultation and supervision)
in ambulatory or other short-term care settings to residents of the area
will be counted. Data on each type of core professional should be
presented separately, in terms of the number of full-time-equivalent
(FTE) practitioners of each type represented.
(b) Definitions:
(i) Core mental health professionals or core professionals includes
those psychiatrists, clinical psychologists, clinical social workers,
psychiatric nurse specialists, and marriage and family therapists who
meet the definitions below.
(ii) Psychiatrist means a doctor of medicine (M.D.) or doctor of
osteopathy (D.O.) who
(A) Is certified as a psychiatrist or child psychiatrist by the
American Medical Specialities Board of Psychiatry and Neurology or by
the American Osteopathic Board of Neurology and Psychiatry, or, if not
certified, is ``broad-eligible'' (i.e., has successfully completed an
accredited program of graduate medical or osteopathic education in
psychiatry or child psychiatry); and
(B) Practices patient care psychiatry or child psychiatry, and is
licensed to do so, if required by the State of practice.
(iii) Clinical psychologist means an individual (normally with a
doctorate in psychology) who is practicing as a clinical or counseling
psychologist and is licensed or certified to do so by the State of
practice; or, if licensure or certification is not required in the State
of practice, an individual with a doctorate in psychology and two years
of supervised clinical or counseling experience. (School psychologists
are not included.)
(iv) Clinical social worker means an individual who--
(A) Is certified as a clinical social worker by the American Board
of Examiners in Clinical Social Work, or is listed on the National
Association of Social Workers' Clinical Register, or has a master's
degree in social work and two years of supervised clinical experience;
and
(B) Is licensed to practice as a social worker, if required by the
State of practice.
(v) Psychiatric nurse specialist means a registered nurse (R.N.)
who--
(A) Is certified by the American Nurses Association as a psychiatric
and mental health clinical nurse specialist, or has a master's degree in
nursing with a specialization in psychiatric/mental health and two years
of supervised clinical experience; and
[[Page 76]]
(B) Is licensed to practice as a psychiatric or mental health nurse
specialist, if required by the State of practice.
(vi) Marriage and family therapist means an individual (normally
with a master's or doctoral degree in marital and family therapy and at
least two years of supervised clinical experience) who is practicing as
a marital and family therapist and is licensed or certified to do so by
the State of practice; or, if licensure or certification is not required
by the State of practice, is eligible for clinical membership in the
American Association for Marriage and Family Therapy.
(c) Practitioners who provide patient care to the population of an
area only on a part-time basis (whether because they maintain another
office elsewhere, spend some of their time providing services in a
facility, are semi-retired, or operate a reduced practice for other
reasons), will be counted on a partial basis through the use of full-
time-equivalency calculations based on a 40-hour week. Every 4 hours (or
\1/2\ day) spent providing patient care services in ambulatory or
inpatient settings will be counted as 0.1 FTE, and each practitioner
providing patient care for 40 or more hours per week as 1.0 FTE. Hours
spent on research, teaching, vocational or educational counseling, and
social services unrelated to mental health will be excluded; if a
practitioner is located wholly or partially outside the service area,
only those services actually provided within the area are to be counted.
(d) In some cases, practitioners located within an area may not be
accessible to the general population of the area under consideration.
Practitioners working in restricted facilities will be included on an
FTE basis based on time spent outside the facility. Examples of
restricted facilities include correctional institutions, youth detention
facilities, residential treatment centers for emotionally disturbed or
mentally retarded children, school systems, and inpatient units of State
or county mental hospitals.
(e) In cases where there are mental health facilities or
institutions providing both inpatient and outpatient services, only
those FTEs providing mental health services in outpatient units or other
short-term care units will be counted.
(f) Adjustments for the following factors will also be made in
computing the number of FTE providers:
(i) Practitioners in residency programs will be counted as 0.5 FTE.
(ii) Graduates of foreign schools who are not citizens or lawful
permanent residents of the United States will be excluded from counts.
(iii) Those graduates of foreign schools who are citizens or lawful
permanent residents of the United States, and practice in certain
settings, but do not have unrestricted licenses to practice, will be
counted on a full-time-equivalency basis up to a maximum of 0.5 FTE.
(g) Practitioners suspended for a period of 18 months or more under
provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act will not be
counted.
4. Determination of unusually high needs for mental health services.
An area will be considered to have unusually high needs for mental
health services if one of the following criteria is met:
(a) 20 percent of the population (or of all households) in the area
have incomes below the poverty level.
(b) The youth ratio, defined as the ratio of the number of children
under 18 to the number of adults of ages 18 to 64, exceeds 0.6.
(c) The elderly ratio, defined as the ratio of the number of persons
aged 65 and over to the number of adults of ages 18 to 64, exceeds 0.25.
(d) A high prevalence of alcoholism in the population, as indicated
by prevalence data showing the area's alcoholism rates to be in the
worst quartile of the nation, region, or State.
(e) A high degree of substance abuse in the area, as indicated by
prevalence data showing the area's substance abuse to be in the worst
quartile of the nation, region, or State.
5. Contiguous area considerations. Mental health professionals in
areas contiguous to an area being considered for designation will be
considered excessively distant, overutilized or inaccessible to the
population of the area under consideration if one of the following
conditions prevails in each contiguous area:
(a) Core mental health professionals in the contiguous area are more
than 40 minutes travel time from the closest population center of the
area being considered for designation (measured in accordance with
paragraph B.1(b) of this part).
(b) The population-to-core-mental-health-professional ratio in the
contiguous area is in excess of 3,000:1 and the population-to-
psychiatrist ratio there is in excess of 10,000:1, indicating that core
mental health professionals in the contiguous areas are overutilized and
cannot be expected to help alleviate the shortage situation in the area
for which designation is being considered. (If data on core mental
health professionals other than psychiatrists are not available for the
contiguous area, a population-to-psychiatrist ratio there in excess of
20,000:1 may be used to demonstrate overutilization.)
(c) Mental health professionals in contiguous areas are inaccessible
to the population of the requested area due to geographic, cultural,
language or other barriers or because of residency restrictions of
programs or facilities providing such professionals.
C. Determination of degree of shortage. Designated areas will be
assigned to degree-of-
[[Page 77]]
shortage groups according to the following table, depending on the ratio
(RC) of population to number of FTE core-mental-health-
service providers (FTEC); the ratio (RP) of
population to number of FTE psychiatrists (FTEP); and the
presence or absence of high needs:
High Needs Not Indicated
Group 1--FTEC=0 and FTEP=0
Group 2--RC gte * 6,000:1 and FTEP=0
Group 3--RC gte 6,000:1 and RP gte 20,000
Group 4(a)--For psychiatrist placements only: All other areas with
FTEP=0 or RP gte 30,000
Group 4(b)--For other mental health practitioner placements: All other
areas with RC gte 9,000:1.
* Note: ``gte'' means ``greater than or equal to''.
High Needs Indicated
Group 1--FTEC=0 and FTEP=0
Group 2--RC gte 4,500:1 and FTEP=0
Group 3--RC gte 4,500:1 and RP gte 15,000
Group 4(a)--For psychiatrist placements only: All other areas with
FTEP=0 or RP gte 20,000
Group 4(b)--For other mental health practitioner placements: All other
areas with RC gte 6,000:1.
D. Determination of Size of Shortage. Size of Shortage (in number of
FTE professionals needed) will be computed using the following formulas:
(1) For areas without unusually high need:
Core professional shortage=area population/6,000-number of FTE core
professionals
Psychiatrist shortage=area population/20,000-number of FTE psychiatrists
(2) For areas with unusually high need:
Core professional shortage=area population/4,500-number of FTE core
professionals
Psychiatrist shortage=area population/15,000-number of FTE psychiatrists
Part II--Population Groups
A. Criteria. Population groups within particular rational mental
health service areas will be designated as having a mental health
professional shortage if the following criteria are met:
1. Access barriers prevent the population group from using those
core mental health professionals which are present in the area; and
2. One of the following conditions prevails:
(a) The ratio of the number of persons in the population group to
the number of FTE core mental health professionals serving the
population group is greater than or equal to 4,500:1 and the ratio of
the number of persons in the population group to the number of FTE
psychiatrists serving the population group is greater than or equal to
15,000:1; or,
(b) The ratio of the number of persons in the population group to
the number of FTE core mental health professionals serving the
population group is greater than or equal to 6,000:1; or,
(c) The ratio of the number of persons in the population group to
the number of FTE psychiatrists serving the population group is greater
than or equal to 20,000:1.
B. Determination of degree of shortage. Designated population groups
will be assigned to the same degree-of-shortage groups defined in part
I.C of this appendix for areas with unusually high needs for mental
health services, using the computed ratio (RC) of the number
of persons in the population group to the number of FTE core mental
health service providers (FTEC) serving the population group,
and the ration (RP) of the number of persons in the
population group to the number of FTE psychiatrists (FTEP)
serving the population group.
C. Determination of size of shortage. Size of shortage will be
computed as follows:
Core professional shortage=number of persons in population group/4,500-
number of FTE core professionals
Psychiatrist shortage=number of persons in population group/15,000-
number of FTE psychiatrists
Part III--Facilities
A. Federal and State Correctional Institutions
1. Criteria.
Medium to maximum security Federal and State correctional
institutions for adults or youth, and youth detention facilities, will
be designated as having a shortage of psychiatric professional(s) if
both of the following criteria are met:
(a) The institution has more than 250 inmates, and
(b) The ratio of the number of internees per year to the number of
FTE psychiatrists serving the institution is at least 2,000:1. (Here the
number of internees is the number of inmates or residents present at the
beginning of the year, plus the number of new inmates or residents
entering the institution during the year, including those who left
before the end of the year; the number of FTE psychiatrists is computed
as in part I, section B, paragraph 3 above.)
2. Determination of Degree of Shortage.
Correctional facilities and youth detention facilities will be
assigned to degree-of-shortage groups, based on the number of inmates
and/or the ratio (R) of internees to FTE psychiatrists, as follows:
Group 1--Facilities with 500 or more inmates or residents and no
psychiatrist.
Group 2--Other facilities with no psychiatrists and facilities with
500 or more inmates or residents and R3,000.
Group 3--All other facilities.
B. State and County Mental Hospitals.
[[Page 78]]
1. Criteria.
A State or county hospital will be designated as having a shortage
of psychiatric professional(s) if both of the following criteria are
met:
(a) The mental hospital has an average daily inpatient census of at
least 100; and
(b) The number of workload units per FTE psychiatrists available at
the hospital exceeds 300, where workload units are calculated using the
following formula:
Total workload units = average daily inpatient census + 2 x (number
of inpatient admissions per year) + 0.5 x (number of admissions to day
care and outpatient services per year).
2. Determination of Degree of Shortage.
State or county mental hospitals will be assigned to degree-of-
shortage groups, based on the ratio (R) of workload units to number of
FTE psychiatrists, as follows:
Group 1--No psychiatrists, or R1,800.
Group 2--1,800R1,200.
Group 3--1,200R600.
Group 4--600R300.
C. Community Mental Health Centers and Other Public or Nonprofit
Private Facilities.
1. Criteria.
A community mental health center (CMHC), authorized by Pub. L. 94-
63, or other public or nonprofit private facility providing mental
health services to an area or population group, may be designated as
having a shortage of psychiatric professional(s) if the facility is
providing (or is responsible for providing) mental health services to an
area or population group designated as having a mental health
professional(s) shortage, and the facility has insufficient capacity to
meet the psychiatric needs of the area or population group.
2. Methodology.
In determining whether CMHCs or other public or nonprofit private
facilities meet the criteria established in paragraph C.1 of this Part,
the following methodology will be used.
(a) Provision of Services to a Designated Area or Population Group.
The facility will be considered to be providing services to a
designated area or population group if either:
(i) A majority of the facility's mental health services are being
provided to residents of designated mental health professional(s)
shortage areas or to population groups designated as having a shortage
of mental health professional(s); or
(ii) The population within a designated psychiatric shortage area or
population group has reasonable access to mental health services
provided at the facility. Such reasonable access will be assumed if the
population lies within 40 minutes travel time of the facility and
nonphysical barriers (relating to demographic and socioeconomic
characteristics of the population) do not prevent the population from
receiving care at the facility.
(b) Responsibility for Provision of Services.
This condition will be considered to be met if the facility, by
Federal or State statute, administrative action, or contractual
agreement, has been given responsibility for providing and/or
coordinating mental health services for the area or population group,
consistent with applicable State plans.
(c) Insufficient capacity to meet mental health service needs. A
facility will be considered to have insufficient capacity to meet the
mental health service needs of the area or population it serves if:
(i) There are more than 1,000 patient visits per year per FTE core
mental health professional on staff of the facility, or
(ii) There are more than 3,000 patient visits per year per FTE
psychiatrist on staff of the facility, or
(iii) No psychiatrists are on the staff and this facility is the
only facility providing (or responsible for providing) mental health
services to the designated area or population.
3. Determination of Degree-of-Shortage.
Each designated facility will be assigned to the same degree-of-
shortage group as the designated area or population group which it
serves.
[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57
FR 2477, Jan. 22, 1992]
Sec. Appendix D to Part 5--Criteria for Designation of Areas Having
Shortages of Vision Care Professional(s)
Part I--Geographic Areas
A. Criteria.
A geographic area will be designated as having a shortage of vision
care professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of vision care
services.
2. The estimated number of optometric visits supplied by vision care
professional(s) in the area is less than the estimated requirements of
the area's population for these visits, and the computed shortage is at
least 1,500 optometric visits.
3. Vision care professional(s) in contiguous areas are excessively
distant, overutilized, or inaccessible to the population of the area
under consideration.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Vision Care Services.
[[Page 79]]
(a) The following areas will be considered rational areas for the
delivery of vision care services:
(i) A county, or a group of contiguous counties whose population
centers are within 40 minutes travel time of each other;
(ii) A portion of a county (or an area made up of portions of more
than one county) whose population, because of topography, market or
transportation patterns, or other factors, has limited access to
contiguous area resources, as measured generally by a travel time of
greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in
determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways:
30 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the distance
corresponding to 40 minutes travel time.
2. Determination of Estimated Requirement for Optometric Visits.
The number of optometric visits required by an area's population
will be estimated by multiplying each of the following visit rates by
the size of the population within that particular age group and then
adding the figures obtained together.
----------------------------------------------------------------------------------------------------------------
Annual number of optometric visits required per person, by age
-----------------------------------------------------------------------
Age 60 and
Under 20 20-29 30-39 40-49 50-59 over
----------------------------------------------------------------------------------------------------------------
Number of visits........................ 0.11 0.20 0.24 0.35 0.41 0.48
----------------------------------------------------------------------------------------------------------------
For geographic areas where the age distribution of the population is
not known, it will be assumed that the percentage distribution, by age
groups, for the area is the same as the distribution for the county of
which it is a part.
(3) Determination of Estimated Supply of Optometric Visits.
The estimated supply of optometric services will be determined by
use of the following formula:
Optometric visits supplied = 3,000 x (number of optometrists under 65)
Optometric visits supplied + 2,000 x (number of optometrists 65 and
over)
Optometric visits supplied + 1,500 x (number of ophthamologists)
(4) Determination of Size of Shortage.
Size of shortage (in number of optometric visits) will be computed
as follows:
Optometric visit shortage = visits required - visits supplied
(5) Contiguous Area Considerations.
Vision care professional(s) in area contiguous to an area being
considered for designation will be considered execessively distant,
overutilized or inaccessible to the population of the area if one of the
following conditions prevails in each contiguous area:
(a) Vision care professional(s) in the contiguous area are more than
40 minutes travel time from the center of the area being considered for
designation (measured in accordance with paragraph B.1(b) of this part).
(b) The estimated requirement for vision care services in the
contiguous area exceeds the estimated supply of such services there,
based on the requirements and supply calculations previously described.
(c) Vision care professional(s) in the contiguous area are
inaccessible to the population of the area because of specified access
barriers (such as economic or cultural barriers).
C. Determination of Degree-of-Shortage.
Designated areas (and population groups) will be assigned to degree-
of-shortage groups, based on the ratio of optometric visits supplied to
optometric visits required for the area (or group), as follows:
Group 1--Areas (or groups) with no optometric visits being supplied
(i.e., with no optometrists or ophthalmologists).
Group 2--Areas (or groups) where the ratio of optometric visits
supplied to optometric visits required is less than 0.5.
Group 3--Areas (or groups) where the ratio of optometric visits
supplied to optometric visits required is between 0.5 and 1.0.
Part II--Population Groups
A. Criteria.
Population groups within particular geographic areas will be
designated if both the following criteria are met:
(1) Members of the population group do not have access to vision
care resources within the area (or in contiguous areas) because of non-
physical access barriers (such as economic or cultural barriers).
(2) The estimated number of optometric visits supplied to the
population group (as determined under paragraph B.3 of part I of this
Appendix) is less than the estimated number of visits required by that
group (as determined under paragraph B.2 of part I of this Appendix),
and the computed shortage is at least 1,500 optometric visits.
[[Page 80]]
B. Determination of Degree of Shortage.
The degree of shortage of a given population group will be
determined in the same way as described for areas in paragraph C of part
I of this appendix.
Sec. Appendix E to Part 5--Criteria for Designation of Areas Having
Shortages of Podiatric Professional(s)
Part I--Geographic Areas
A. Criteria.
A geographic area will be designated as having a shortage of
podiatric professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of podiatric
services.
2. The area's ratio of population to foot care practitioners is at
least 28,000:1, and the computed podiatrist shortage to meet this ratio
is at least 0.5.
3. Podiatric professional(s) in contiguous areas are overutilized,
excessively distant, or inaccessible to the population of the area under
consideration.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this Part, the following methodology will be used:
1. Rational Areas for the Delivery of Podiatric Services.
(a) The following areas will be considered rational areas for the
delivery of podiatric services:
(i) A county or a group of contiguous counties whose population
centers are within 40 minutes travel time of each other.
(ii) A portion of a county, or an area made up of portions of more
than one county, whose population, because of topography, market and/or
transportation patterns or other factors, has limited access to
contiguous area resources, as measured generally by a travel time of
greater than 40 minutes from its population center to these resources.
(b) The following distances will be used as guidelines in
determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways:
30 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the area
corresponding to 40 minutes travel time.
2. Population Count.
The population count used will be the total permanent resident
civilian population of the area, excluding inmates of institutions,
adjusted by the following formula to take into account the differing
utilization rates of podiatric services by different age groups within
the population:
Adjusted population=total population x (1 + 2.2 x (percent of population
65 and over) - 0.44 x (percent of population under 17)).
3. Counting of Foot Care Practitioners.
(a) All podiatrists providing patient care will be counted. However,
in order to take into account productivity differences in podiatric
practices associated with the age of the podiatrists, the following
formula will be utilized:
Number of FTE podiatrists = 1.0 x (podiatrists under age 55)
+ .8 x (podiatrists age 55 and over)
(b) In order to take into account the fact that orthopedic surgeons
and general and family practitioners devote a percentage of their time
to foot care, the total available foot care practitioners will be
computed as follows:
Number of foot care practitioners = number of FTE podiatrists
+ .15 x (number of orthopedic surgeons)
+ .02 x (number of general and family practioners).
4. Determination of Size of Shortage.
Size of shortage (in number of FTE podiatrists) will be computed as
follows:
Podiatrist shortage = adjusted population / 28,000 - number of FTE foot
care practitioners.
5. Contiguous Area Considerations.
Podiatric professional(s) in areas contiguous to an area being
considered for designation will be considered excessively distant,
overutilized or inaccessible to the population of the area under
consideration if one of the following conditions prevails in each
contiguous area:
(a) Podiatric professional(s) in the contiguous area are more than
40 minutes travel time from the center of the area being considered for
designation.
(b) The population-to-foot care practitioner ratio in the contiguous
areas is in excess of 20,000:1, indicating that contiguous area
podiatric professional(s) cannot be expected to help alleviate the
shortage situation in the area for which designation is requested.
(c) Podiatric professional(s) in the contiguous area are
inaccessible to the population of the area under consideration because
of specified access barriers (such as economic or cultural barriers).
C. Determination of Degree of Shortage.
Designated areas will be assigned to groups, based on the ratio (R)
of adjusted population to number of foot care practitioners, as follows:
[[Page 81]]
Group 1 Areas with no foot care practitioners, and areas with R
50,000 and no podiatrists.
Group 2 Other areas with R 50,000.
Group 3 Areas with 50,000 R 28,000.
Sec. Appendix F to Part 5--Criteria for Designation of Areas Having
Shortages of Pharmacy Professional(s)
Part I--Geographic Areas
A. Criteria.
A geographic area will be designated as having a shortage of
pharmacy professional(s) if the following three criteria are met:
1. The area is a rational area for the delivery of pharmacy
services.
2. The number of pharmacists serving the area is less than the
estimated requirement for pharmacists in the area, and the computed
pharmacist shortage is at least 0.5.
3. Pharmacists in contiguous areas are overutilized or excessively
distant from the population of the area under consideration.
B. Methodology.
In determining whether an area meets the criteria established by
paragraph A of this Part, the following methodology will be used:
1. Rational Areas for the Delivery of Pharmacy Services.
(a) The following areas will be considered rational areas for the
delivery of pharmacy services:
(i) A county, or a group of contiguous counties whose population
centers are within 30 minutes travel time of each other; and
(ii) A portion of a county, or an area made up of portions of more
than one county, whose population, because of topography, market or
transportation patterns or other factors, has limited access to
contiguous area resources, as measured generally by a travel time of
greater than 30 minutes to these resources.
(b) The following distances will be used as guidelines in
determining distances corresponding to 30 minutes travel time:
(i) Under normal conditions with primary roads available: 20 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 15 miles.
(iii) In flat terrain or in areas connected by interstate highways:
25 miles.
Within inner portions of metropolitan areas, information on the
public transportation system will be used to determine the area
corresponding to 30 minutes travel time.
2. Counting of Pharmacists.
All active pharmacists within the area will be counted, except those
engaged in teaching, administration, or pharmaceutical research.
3. Determination of Estimated Requirement for Pharmacists.
(a) Basic estimate. The basic estimated requirement for pharmacists
will be calculated as follows:
Basic pharmacist requirement = .15 x (resident civilian population/
1,000) + .035 x (total number of physicians engaged in patient
care in the area).
(b) Adjusted estimate. For areas with less than 20,000 persons, the
following adjustment is made to the basic estimate to compensate for the
lower expected productivity of small practices.
Estimated pharmacist requirement = (2 - population/20,000) x basic
pharmacist requirement.
4. Size of Shortage Computation.
The size of the shortage will be computed as follows:
Pharmacist shortage = estimated pharmacist requirement - number of
pharmacists available.
5. Contiguous Area Considerations.
Pharmacists in areas contiguous to an area being considered for
designation will be considered excessively distant or overutilized if
either:
(a) Pharmacy professional(s) in contiguous areas are more than 30
minutes travel time from the center of the area under consideration, or
(b) The number of pharmacists in each contiguous area is less than
or equal to the estimated requirement for pharmacists for that
contiguous area (as computed above).
C. Determination of Degree-of-Shortage.
Designated areas will be assigned to degree-of-shortage groups,
based on the proportion of the estimated requirement for pharmacists
which is currently available in the area, as follows:
Group 1--Areas with no pharmacists.
Group 2--Areas where the ratio of available pharmacists to
pharmacists required is less than 0.5.
Group 3--Areas where the ratio of available pharmacists to
pharmacists required is between 0.5 and 1.0.
Sec. Appendix G to Part 5--Criteria for Designation of Areas Having
Shortages of Veterinary Professional(s)
Part I--Geographic Areas
A. Criteria for Food Animal Veterinary Shortage.
A geographic area will be designated as having a shortage of food
animal veterinary professional(s) if the following three criteria are
met:
[[Page 82]]
1. The area is a rational area for the delivery of veterinary
services.
2. The ratio of veterinary livestock units to food animal
veterinarians in the area is at least 10,000:1, and the computed food
animal veterinarian shortage to meet this ratio is at least 0.5.
3. Food animal veterinarians in contiguous areas are overutilized or
excessively distant from the population of the area under consideration.
B. Criteria for Companion Animal Veterinary Shortage.
A geographic area will be designated as having a shortage of
companion animal veterinary professional(s) if the following three
criteria are met:
1. The area is a rational area for the delivery of veterinary
services.
2. The ratio of resident civilian population to number of companion
animal veterinarians in the area is at least 30,000:1 and the computed
companion animal veterinary shortage to meet this ratio is at least 0.5.
3. Companion animal veterinarians in contiguous areas are
overutilized or excessively distant from the population of the area
under consideration.
C. Methodology.
In determining whether an area meets the criteria established by
paragraphs A and B of this part, the following methodology will be used:
1. Rational Areas for the Delivery of Veterinary Services.
(a) The following areas will be considered rational areas for the
delivery of veterinary services:
(i) A county, or a group of contiguous counties whose population
centers are within 40 minutes travel time of each other.
(ii) A portion of a county (or an area made up of portions of more
than one county) which, because of topography, market and/or
transportation patterns or other factors, has limited access to
contiguous area resources, as measured generally by a travel time of
greater than 40 minutes to these resources.
(b) The following distances will be used as guidelines in
determining distances corresponding to 40 minutes travel time:
(i) Under normal conditions with primary roads available: 25 miles.
(ii) In mountainous terrain or in areas with only secondary roads
available: 20 miles.
(iii) In flat terrain or in areas connected by interstate highways:
30 miles.
2. Determination of Number of Veterinary Livestock Units (VLU)
Requiring Care.
Since various types of food animals require varying amounts of
veterinary care, each type of animal has been assigned a weight
indicating the amount of veterinary care it requires relative to that
required by a milk cow. Those weights are used to compute the number of
``Veterinary Livestock Units'' (VLU) for which veterinary care is
required.
The VLU is computed as follows:
Veterinary Livestock Units (VLU)=(number of milk cows)
+.2x(number of other cattle and calves)
+.05x(number of hogs and pigs)
+.05x(number of sheep)
+.002x(number of poultry).
3. Counting of Food Animal Veterinarians.
The number of food animal veterinarians is determined by weighting
the number of veterinarians within each of several practice categories
according to the average fraction of practice time in that category
which is devoted to food animal veterinary care, as follows:
Number of Food Animal Veterinarians=(number of veterinarians in large
animal practice, exclusively)
+(number of veterinarians in bovine practice, exclusively)
+(number of veterinarians in poultry practice, exclusively)
+.75x(mixed practice veterinarians with greater than 50% of practice in
large animal care)
+.5x(mixed practice veterinarians with approximately 50% of practice in
large animal care)
+.25x(mixed practice veterinarians with less than 50% of practice in
large animal care).
4. Counting of Companion Animal Veterinarians (that is, those who
provide services for dogs, cats, horses, and any other animals
maintained as companions to the owner rather than as food animals).
The number of full-time equivalent companion animal veterinarians is
determined by weighting the number of veterinarians within each of
several practice categories by the average portion of their practice
which is devoted to companion animal care by the practitioners within
that category, as follows:
Number of Companion Animal Veterinarians=(number of veterinarians in
large animal practice, exclusively)
+(number of veterinarians in equine practice, exclusively)
+.75x(mixed practice veterinarians with greater than 50% of practice in
small animal care)
+.5x(mixed practice veterinarians with approximately 50% of practice in
small animal care)
+.25x(mixed practice veterinarians with less than 50% of practice in
small animal care).
5. Size of Shortage Computation.
The size of shortage will be computed as follows:
(a) Food animal veterinarian shortage=(VLU/10,000)-(number of food
animal veterinarians).
(b) Companion animal veterinarian shortage=(resident civilian pop./
[[Page 83]]
30,000)-(number of companion animal veterinarians).
6. Contiguous Area Considerations.
Veterinary professional(s) in areas contiguous to an area being
considered for designation will be considered excessively distant from
the population of the area or overutilized if one of the following
conditions prevails in each contiguous area:
(a) Veterinary professional(s) in the contiguous area are more than
60 minutes travel time from the center of the area being considered for
designation (measured in accordance with paragraph C.1.(b) of this
part).
(b) In the case of food animal veterinary professional(s), the VLU-
to-food animal veterinarian ratio in the contiguous area is in excess of
5,000:1.
(c) In the case of companion animal veterinary professional(s), the
population-to-companion animal veterinarian ratio in the contiguous area
is in excess of 15,000:1.
C. Determination of Degree-of-Shortage.
Designated areas will be assigned to degree-of-shortage groups as
follows:
Group 1--Areas with a food animal veterinarian shortage and no
veterinarians.
Group 2--Areas (not included above) with a food animal veterinarian
shortage and no food animal veterinarians.
Group 3--All other food animal veterinarian shortage areas.
Group 4--All companion animal shortage areas (not included above)
having no veterinarians.
Group 5--All other companion animal shortage areas.
PART 5a_RURAL PHYSICIAN TRAINING GRANT PROGRAM--Table of Contents
Sec.
5a.1 Statutory basis and purpose.
5a.2 Applicability.
5a.3 Definition of Underserved Rural Community.
Authority: Sec. 749B of the Public Health Service Act (42 U.S.C.
293k) as amended.
Source: 75 FR 29451, May 26, 2010, unless otherwise noted.
Sec. 5a.1 Statutory basis and purpose.
This part implements section 749B(f) of the Public Health Service
Act. These provisions define ``underserved rural community'' for
purposes of the Rural Physician Training Grant Program.
Sec. 5a.2 Applicability.
This part applies to grants made under section 749B of the Public
Health Service Act.
Sec. 5a.3 Definition of Underserved Rural Community.
Underserved Rural Community means a community:
(a) Located in:
(1) A non-Metropolitan County or Micropolitan county; or
(2) If it is within a Metropolitan county, all Census Tracts that
are assigned a Rural-Urban Commuting Area (RUCAs) codes of 4-10; or
(3) Census Tracts within a Metropolitan Area with RUCA codes 2 and 3
that are larger than 400 square miles and have population density of
less than 30 people per square mile; and
(b) Located in a current:
(1) Federally-designated Primary Health Care Geographic Health
Professions Shortage Area, (under section 332(a)(1)(A) of the Public
Health Service Act) or
(2) Federally-designated Medically Underserved Area (under section
330(b)(3) of the Public Health Service Act).
PART 6_FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES
AND INDIVIDUALS--Table of Contents
Sec.
6.1 Applicability.
6.2 Definitions.
6.3 Eligible entities.
6.4 Covered individuals.
6.5 Deeming process for eligible entities.
6.6 Covered acts and omissions.
Authority: Sections 215 and 224 of the Public Health Service Act, 42
U.S.C. 216 and 233.
Source: 60 FR 22532, May 8, 1995, unless otherwise noted.
Sec. 6.1 Applicability.
This part applies to entities and individuals whose acts and
omissions related to the performance of medical, surgical, dental, or
related functions are covered by the Federal Tort Claims Act (28 U.S.C.
1346(b) and 2671-2680) in accordance with the provisions of section
224(g) of the Public Health Service Act (42 U.S.C. 233(g)).
Sec. 6.2 Definitions.
Act means the Public Health Service Act, as amended.
Attorney General means the Attorney General of the United States and
any
[[Page 84]]
other officer or employee of the Department of Justice to whom the
authority involved has been delegated.
Covered entity means an entity described in Sec. 6.3 which has been
deemed by the Secretary, in accordance with Sec. 6.5, to be covered by
this part.
Covered individual means an individual described in Sec. 6.4.
Effective date as used in Sec. 6.5 and Sec. 6.6 refers to the date
of the Secretary's determination that an entity is a covered entity.
Secretary means the Secretary of Health and Human Services (HHS) and
any other officer or employee of the Department of HHS to whom the
authority involved has been delegated.
Subrecipient means an entity which receives a grant or a contract
from a covered entity to provide a full range of health services on
behalf of the covered entity.
Sec. 6.3 Eligible entities.
(a) Grantees. Entities eligible for coverage under this part are
public and nonprofit private entities receiving Federal funds under any
of the following grant programs:
(1) Section 329 of the Act (relating to grants for migrant health
centers);
(2) Section 330 of the Act (relating to grants for community health
centers);
(3) Section 340 of the Act (relating to grants for health services
for the homeless); and
(4) Section 340A of the Act (relating to grants for health services
for residents of public housing).
(b) Subrecipients. Entities that are subrecipients of grant funds
described in paragraph (a) of this section are eligible for coverage
only if they provide a full range of health care services on behalf of
an eligible grantee and only for those services carried out under the
grant funded project.
Sec. 6.4 Covered individuals.
(a) Officers and employees of a covered entity are eligible for
coverage under this part.
(b) Contractors of a covered entity who are physicians or other
licensed or certified health care practitioners are eligible for
coverage under this part if they meet the requirements of section
224(g)(5) of the Act.
(c) An individual physician or other licensed or certified health
care practitioner who is an officer, employee, or contractor of a
covered entity will not be covered for acts or omissions occurring after
receipt by the entity employing such individual of notice of a final
determination by the Attorney General that he or she is no longer
covered by this part, in accordance with section 224(i) of the Act.
Sec. 6.5 Deeming process for eligible entities.
Eligible entities will be covered by this part only on and after the
effective date of a determination by the Secretary that they meet the
requirements of section 224(h) of the Act. In making such determination,
the Secretary will receive such assurances and conduct such
investigations as he or she deems necessary.
Sec. 6.6 Covered acts and omissions.
(a) Only acts and omissions occurring on and after the effective
date of the Secretary's determination under Sec. 6.5 and before the
later date specified in section 224(g)(3) of the Act are covered by this
part.
(b) Only claims for damage for personal injury, including death,
resulting from the performance of medical, surgical, dental, or related
functions are covered by this part.
(c) With respect to covered individuals, only acts and omissions
within the scope of their employment (or contract for services) are
covered. If a covered individual is providing services which are not on
behalf of the covered entity, such as on a volunteer basis or on behalf
of a third-party (except as described in paragraph (d) of this section),
whether for pay or otherwise, acts and omissions which are related to
such services are not covered.
(d) Only acts and omissions related to the grant-supported activity
of entities are covered. Acts and omissions related to services provided
to individuals who are not patients of a covered entity will be covered
only if the Secretary determines that:
(1) The provision of the services to such individuals benefits
patients of the entity and general populations that could be served by
the entity through
[[Page 85]]
community-wide intervention efforts within the communities served by
such entity;
(2) The provision of the services to such individuals facilitates
the provision of services to patients of the entity; or
(3) Such services are otherwise required to be provided to such
individuals under an employment contract or similar arrangement between
the entity and the covered individual.
(e) Examples. The following are examples of situations within the
scope of paragraph (d) of this section:
(1) A community health center deemed to be a covered entity
establishes a school-based or school-linked health program as part of
its grant supported activity. Even though the students treated are not
necessarily registered patients of the center, the center and its health
care practitioners will be covered for services provided, if the
Secretary makes the determination in paragraph (d)(1) of this section.
(2) A migrant health center requires its physicians to obtain staff
privileges at a community hospital. As a condition of obtaining such
privileges, and thus being able to admit the center's patients to the
hospital, the physicians must agree to provide occasional coverage of
the hospital's emergency room. The Secretary would be authorized to
determine that this coverage is necessary to facilitate the provision of
services to the grantee's patients, and that it would therefore be
covered by paragraph (d)(2) of this section.
(3) A homeless health services grantee makes arrangements with local
community providers for after-hours coverage of its patients. The
grantee's physicians are required by their employment contracts to
provide periodic cross-coverage for patients of these providers, in
order to make this arrangement feasible. The Secretary may determine
that the arrangement is within the scope of paragraph (d)(3) of this
section.
(4) For the specific activities described in this paragraph (e)(4),
when carried out by an entity (and its eligible personnel) that has been
covered under paragraph (c) of this section, the Department has
determined that coverage is provided under paragraph (d) of this
section, without the need for specific application for an additional
coverage determination under paragraph (d) of this section, if the
activity or arrangement in question fits squarely within these
descriptions; otherwise, the health center should seek a particularized
determination of coverage.
(i) Community-Wide Interventions. (A) School-Based Clinics: Health
center staff provide primary and preventive health care services at a
facility located in a school or on school grounds. The health center has
a written affiliation agreement with the school.
(B) School-Linked Clinics: Health center staff provide primary and
preventive health care services, at a site not located on school
grounds, to students of one or more schools. The health center has a
written affiliation agreement with each school.
(C) Health Fairs: On behalf of the health center, health center
staff conduct or participate in an event to attract community members
for purposes of performing health assessments. Such events may be held
in the health center, outside on its grounds, or elsewhere in the
community.
(D) Immunization Campaigns: On behalf of the health center, health
center staff conduct or participate in an event to immunize individuals
against infectious illnesses. The event may be held at the health
center, schools, or elsewhere in the community.
(E) Migrant Camp Outreach: Health center staff travel to a migrant
farmworker residence camp to conduct intake screening to determine those
in need of clinic services (which may mean health care is provided at
the time of such intake activity or during subsequent clinic staff
visits to the camp).
(F) Homeless Outreach: Health center staff travel to a shelter for
homeless persons, or a street location where homeless persons
congregate, to conduct intake screening to determine those in need of
clinic services (which may mean health care is provided at the time of
such intake activity or during subsequent clinic staff visits to that
location).
(ii) Hospital-Related Activities. Periodic hospital call or hospital
emergency room coverage is required by the
[[Page 86]]
hospital as a condition for obtaining hospital admitting privileges.
There must also be documentation for the particular health care provider
that this coverage is a condition of employment at the health center.
(iii) Coverage-Related Activities. As part of a health center's
arrangement with local community providers for after-hours coverage of
its patients, the health center's providers are required by their
employment contract to provide periodic or occasional cross-coverage for
patients of these providers.
(iv) Coverage in Certain Individual Emergencies. A health center
provider is providing or undertaking to provide covered services to a
health center patient within the approved scope of project of the
center, or to an individual who is not a patient of the health center
under the conditions set forth in this rule, when the provider is then
asked, called upon, or undertakes, at or near that location and as the
result of a non-health center patient's emergency situation, to
temporarily treat or assist in treating that non-health center patient.
In addition to any other documentation required for the original
services, the health center must have documentation (such as employee
manual provisions, health center bylaws, or an employee contract) that
the provision of individual emergency treatment, when the practitioner
is already providing or undertaking to provide covered services, is a
condition of employment at the health center.
[60 FR 22532, May 8, 1995; 60 FR 36073, July 13, 1995; 78 FR 58204,
Sept. 23, 2013]
PART 7_DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL
PREPARATIONS--Table of Contents
Sec.
7.1 Applicability.
7.2 Establishment of a user charge.
7.3 Definitions.
7.4 Schedule of charges.
7.5 Payment procedures.
7.6 Exemptions.
Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title
V of the Independent Offices Appropriations Act of 1952 (31 U.S.C.
9701); and secs. 301(a) and 352 of the Public Health Service Act, as
amended (42 U.S.C. 241(a) and 263).
Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.
Sec. 7.1 Applicability.
The provisions of this part are applicable to private entities
requesting from the Centers for Disease Control and Prevention (CDC)
reference biological Standards and Biological preparations for use in
their laboratories.
[78 FR 43820, July 22, 2013]
Sec. 7.2 Establishment of a user charge.
Except as otherwise provided in Sec. 7.6, a user charge shall be
imposed to cover the cost to CDC of producing and distributing reference
biological standards and biological preparations.
Sec. 7.3 Definitions.
Biological standards means a uniform and stable reference biological
substance which allows measurements of relative potency to be made and
described in a common currency of international and national units of
activity.
Biological preparations means a reference biological substance which
may be used for a purpose similar to that of a standard, but which has
been established without a full collaborative study, or where a
collaborative study has shown that it is not appropriate to establish
the preparation as an international standard.
Sec. 7.4 Schedule of charges.
The charges imposed in Sec. 7.2 are based on the amount published
in CDC's price list of available products. These changes will reflect
direct costs (such as salaries and equipment), indirect costs (such as
rent, telephone service, and a proportionate share of management and
administrative costs), and the cost of particular ingredients. Charges
may vary over time and between different biological standards or
biological preparations, depending upon the cost of ingredients and the
complexity of production. An up-to-date schedule of charges is available
from the Division of Scientific Resources, Centers for Disease Control,
[[Page 87]]
1600 Clifton Road NE., MS C-17, Atlanta, Georgia, 30333 or 404-639-3466.
[78 FR 43820, July 22, 2013]
Sec. 7.5 Payment procedures.
An up-to-date fee schedule and instructions for terms of payment are
available from the Division of Scientific Resources, Centers for Disease
Control and Prevention, 1600 Clifton Road, MS C-17, Atlanta, Georgia
30333 or 404-639-3466. Any changes in the fee schedule will be published
in the Federal Register. The fee must be paid in U.S. dollars at the
time that the requester requests the biological reference standard or
biological preparation.
[78 FR 43820, July 22, 2013]
Sec. 7.6 Exemptions.
State and local health departments, governmental institutions (e.g.,
State hospitals and universities), the World Health Organization, and
ministries of health of foreign governments may be exempted from paying
user charges, when using biological standards or biological preparations
for public health purposes.
PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents
Subpart A_Accreditation
Sec.
8.1 Scope.
8.2 Definitions.
8.3 Application for approval as an accreditation body.
8.4 Accreditation body responsibilities.
8.5 Periodic evaluation of accreditation bodies.
8.6 Withdrawal of approval of accreditation bodies.
Subpart B_Certification and Treatment Standards
8.11 Opioid treatment program certification.
8.12 Federal opioid treatment standards.
8.13 Revocation of accreditation and accreditation body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.
Subpart C_Procedures for Review of Suspension or Proposed Revocation of
OTP Certification, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official and
calculation of deadlines.
8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-
23, 300x-27(a), 300y-11.
Source: 66 FR 4090, Jan. 17, 2001, unless otherwise noted.
Subpart A_Accreditation
Sec. 8.1 Scope.
The regulations in this part establish the procedures by which the
Secretary of Health and Human Services (the Secretary) will determine
whether a practitioner is qualified under section 303(g) of the
Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs in
the treatment of opioid addiction. These regulations also establish the
Secretary's standards regarding the appropriate quantities of opioid
drugs that may be provided for unsupervised use by individuals
undergoing such treatment (21 U.S.C. 823(g)(1)). Under these
regulations, a practitioner who intends to dispense opioid drugs in the
treatment of opioid addiction must first obtain from the Secretary or by
delegation, from the Administrator, Substance Abuse and Mental Health
Services Administration (SAMHSA), a certification that the practitioner
is
[[Page 88]]
qualified under the Secretary's standards and will comply with such
standards. Eligibility for certification will depend upon the
practitioner obtaining accreditation from an accreditation body that has
been approved by SAMHSA. These regulations establish the procedures
whereby an entity can apply to become an approved accreditation body.
This part also establishes requirements and general standards for
accreditation bodies to ensure that practitioners are consistently
evaluated for compliance with the Secretary's standards for opiate
addiction treatment with an opioid agonist treatment medication.
Sec. 8.2 Definitions.
The following definitions apply to this part:
Accreditation means the process of review and acceptance by an
accreditation body.
Accreditation body means a body that has been approved by SAMHSA
under Sec. 8.3 to accredit opioid treatment programs using opioid
agonist treatment medications.
Accreditation body application means the application filed with
SAMHSA for purposes of obtaining approval as an accreditation body, as
described in Sec. 8.3(b).
Accreditation elements mean the elements or standards that are
developed and adopted by an accreditation body and approved by SAMHSA.
Accreditation survey means an onsite review and evaluation of an
opioid treatment program by an accreditation body for the purpose of
determining compliance with the Federal opioid treatment standards
described in Sec. 8.12.
Accredited opioid treatment program means an opioid treatment
program that is the subject of a current, valid accreditation from an
accreditation body approved by SAMHSA under Sec. 8.3(d).
Certification means the process by which SAMHSA determines that an
opioid treatment program is qualified to provide opioid treatment under
the Federal opioid treatment standards.
Certification application means the application filed by an opioid
treatment program for purposes of obtaining certification from SAMHSA,
as described in Sec. 8.11(b).
Certified opioid treatment program means an opioid treatment program
that is the subject of a current, valid certification under Sec. 8.11.
Comprehensive maintenance treatment is maintenance treatment
provided in conjunction with a comprehensive range of appropriate
medical and rehabilitative services.
Detoxification treatment means the dispensing of an opioid agonist
treatment medication in decreasing doses to an individual to alleviate
adverse physical or psychological effects incident to withdrawal from
the continuous or sustained use of an opioid drug and as a method of
bringing the individual to a drug-free state within such period.
Federal opioid treatment standards means the standards established
by the Secretary in Sec. 8.12 that are used to determine whether an
opioid treatment program is qualified to engage in opioid treatment. The
Federal opioid treatment standards established in Sec. 8.12 also
include the standards established by the Secretary regarding the
quantities of opioid drugs which may be provided for unsupervised use.
For-cause inspection means an inspection of an opioid treatment
program by the Secretary, or by an accreditation body, that may be
operating in violation of Federal opioid treatment standards, may be
providing substandard treatment, or may be serving as a possible source
of diverted medications.
Interim maintenance treatment means maintenance treatment provided
in conjunction with appropriate medical services while a patient is
awaiting transfer to a program that provides comprehensive maintenance
treatment.
Long-term detoxification treatment means detoxification treatment
for a period more than 30 days but not in excess of 180 days.
Maintenance treatment means the dispensing of an opioid agonist
treatment medication at stable dosage levels for a period in excess of
21 days in the treatment of an individual for opioid addiction.
[[Page 89]]
Medical director means a physician, licensed to practice medicine in
the jurisdiction in which the opioid treatment program is located, who
assumes responsibility for administering all medical services performed
by the program, either by performing them directly or by delegating
specific responsibility to authorized program physicians and healthcare
professionals functioning under the medical director's direct
supervision.
Medical and rehabilitative services means services such as medical
evaluations, counseling, and rehabilitative and other social programs
(e.g., vocational and educational guidance, employment placement), that
are intended to help patients in opioid treatment programs become and/or
remain productive members of society.
Medication unit means a facility established as part of, but
geographically separate from, an opioid treatment program from which
licensed private practitioners or community pharmacists dispense or
administer an opioid agonist treatment medication or collect samples for
drug testing or analysis.
Opiate addiction is defined as a cluster of cognitive, behavioral,
and physiological symptoms in which the individual continues use of
opiates despite significant opiate-induced problems. Opiate dependence
is characterized by repeated self-administration that usually results in
opiate tolerance, withdrawal symptoms, and compulsive drug-taking.
Dependence may occur with or without the physiological symptoms of
tolerance and withdrawal.
Opioid agonist treatment medication means any opioid agonist drug
that is approved by the Food and Drug Administration under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in
the treatment of opiate addiction.
Opioid drug means any drug having an addiction-forming or addiction-
sustaining liability similar to morphine or being capable of conversion
into a drug having such addiction-forming or addiction-sustaining
liability.
Opioid treatment means the dispensing of an opioid agonist treatment
medication, along with a comprehensive range of medical and
rehabilitative services, when clinically necessary, to an individual to
alleviate the adverse medical, psychological, or physical effects
incident to opiate addiction. This term encompasses detoxification
treatment, short-term detoxification treatment, long-term detoxification
treatment, maintenance treatment, comprehensive maintenance treatment,
and interim maintenance treatment.
Opioid treatment program or ``OTP'' means a program or practitioner
engaged in opioid treatment of individuals with an opioid agonist
treatment medication.
Patient means any individual who undergoes treatment in an opioid
treatment program.
Program sponsor means the person named in the application for
certification described in Sec. 8.11(b) as responsible for the
operation of the opioid treatment program and who assumes responsibility
for all its employees, including any practitioners, agents, or other
persons providing medical, rehabilitative, or counseling services at the
program or any of its medication units. The program sponsor need not be
a licensed physician but shall employ a licensed physician for the
position of medical director.
Registered opioid treatment program means an opioid treatment
program that is registered under 21 U.S.C. 823(g).
Short-term detoxification treatment means detoxification treatment
for a period not in excess of 30 days.
State Authority is the agency designated by the Governor or other
appropriate official designated by the Governor to exercise the
responsibility and authority within the State or Territory for governing
the treatment of opiate addiction with an opioid drug.
Treatment plan means a plan that outlines for each patient
attainable short-term treatment goals that are mutually acceptable to
the patient and the opioid treatment program and which specifies the
services to be provided and the frequency and schedule for their
provision.
[[Page 90]]
Sec. 8.3 Application for approval as an accreditation body.
(a) Eligibility. Private nonprofit organizations or State
governmental entities, or political subdivisions thereof, capable of
meeting the requirements of this part may apply for approval as an
accreditation body.
(b) Application for initial approval. Three copies of an
accreditation body application form [SMA-163] shall be submitted to
SAMHSA at rm. 12-105, 5600 Fishers Lane, Rockville, MD 20857, and marked
ATTENTION: OTP Certification Program. SAMHSA will consider and accept
the electronic submission of these materials when electronic submission
systems are developed and available. Accreditation body applications
shall include the following information and supporting documentation:
(1) Name, address, and telephone number of the applicant and a
responsible official for the accreditation body. The application shall
be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the applicant is not a State governmental entity or
political subdivision;
(3) A set of the accreditation elements or standards and a detailed
discussion showing how the proposed accreditation elements or standards
will ensure that each OTP surveyed by the applicant is qualified to meet
or is meeting each of the Federal opioid treatment standards set forth
in Sec. 8.12;
(4) A detailed description of the applicant's decisionmaking
process, including:
(i) Procedures for initiating and performing onsite accreditation
surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines,
instructions, and other materials the applicant will send to OTPs during
the accreditation process, including a request for a complete history of
prior accreditation activities and a statement that all information and
data submitted in the application for accreditation is true and
accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and SAMHSA of
deficiencies and for monitoring corrections of deficiencies by OTPs;
(v) Policies and procedures for suspending or revoking an OTP's
accreditation;
(vi) Policies and procedures that will ensure processing of
applications for accreditation and applications for renewal of
accreditation within a timeframe approved by SAMHSA; and
(vii) A description of the applicant's appeals process to allow OTPs
to contest adverse accreditation decisions.
(5) Policies and procedures established by the accreditation body to
avoid conflicts of interest, or the appearance of conflicts of interest,
by the applicant's board members, commissioners, professional personnel,
consultants, administrative personnel, and other representatives;
(6) A description of the education, experience, and training
requirements for the applicant's professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician on the applicant's staff;
(7) A description of the applicant's training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the body will comply with the
requirements of Sec. 8.4, including a contingency plan for
investigating complaints under Sec. 8.4(e);
(10) Policies and procedures established to protect confidential
information the applicant will collect or receive in its role as an
accreditation body; and
(11) Any other information SAMHSA may require.
(c) Application for renewal of approval. An accreditation body that
intends to continue to serve as an accreditation body beyond its current
term shall apply to SAMHSA for renewal, or notify SAMHSA of its
intention not to apply for renewal, in accordance with the following
procedures and schedule:
(1) At least 9 months before the date of expiration of an
accreditation body's term of approval, the body shall inform SAMHSA in
writing of its intent to seek renewal.
[[Page 91]]
(2) SAMHSA will notify the applicant of the relevant information,
materials, and supporting documentation required under paragraph (b) of
this section that the applicant shall submit as part of the renewal
procedure.
(3) At least 3 months before the date of expiration of the
accreditation body's term of approval, the applicant shall furnish to
SAMHSA three copies of a renewal application containing the information,
materials, and supporting documentation requested by SAMHSA under
paragraph (c)(2) of this section.
(4) An accreditation body that does not intend to renew its approval
shall so notify SAMHSA at least 9 months before the expiration of the
body's term of approval.
(d) Rulings on applications for initial approval or renewal of
approval. (1) SAMHSA will grant an application for initial approval or
an application for renewal of approval if it determines the applicant
substantially meets the accreditation body requirements of this subpart.
(2) If SAMHSA determines that the applicant does not substantially
meet the requirements set forth in this subpart. SAMHSA will notify the
applicant of the deficiencies in the application and request that the
applicant resolve such deficiencies within 90 days of receipt of the
notice. If the deficiencies are resolved to the satisfaction of SAMHSA
within the 90-day time period, the body will be approved as an
accreditation body. If the deficiencies have not been resolved to the
satisfaction of SAMHSA within the 90-day time period, the application
for approval as an accreditation body will be denied.
(3) If SAMHSA does not reach a final decision on a renewal
application before the expiration of an accreditation body's term of
approval, the approval will be deemed extended until SAMHSA reaches a
final decision, unless an accreditation body does not rectify
deficiencies in the application within the specified time period, as
required in paragraph (d)(2) of this section.
(e) Relinquishment of approval. An accreditation body that intends
to relinquish its accreditation approval before expiration of the body's
term of approval shall submit a letter of such intent to SAMHSA, at the
address in paragraph (b) of this section, at least 9 months before
relinquishing such approval.
(f) Notification. An accreditation body that does not apply for
renewal of approval, or is denied such approval by SAMHSA, relinquishes
its accreditation approval before expiration of its term of approval, or
has its approval withdrawn, shall:
(1) Transfer copies of records and other related information as
required by SAMHSA to a location, including another accreditation body,
and according to a schedule approved by SAMHSA; and
(2) Notify, in a manner and time period approved by SAMHSA, all OTPs
accredited or seeking accreditation by the body that the body will no
longer have approval to provide accreditation services.
(g) Term of approval. An accreditation body's term of approval is
for a period not to exceed 5 years.
(h) State accreditation bodies. State governmental entities,
including political subdivisions thereof, may establish organizational
units that may act as accreditation bodies, provided such units meet the
requirements of this section, are approved by SAMHSA under this section,
and have taken appropriate measures to prevent actual or apparent
conflicts of interest, including cases in which State or Federal funds
are used to support opioid treatment services.
Sec. 8.4 Accreditation body responsibilities.
(a) Accreditation surveys and for cause inspections. (1)
Accreditation bodies shall conduct routine accreditation surveys for
initial, renewal, and continued accreditation of each OTP at least every
3 years.
(2) Accreditation bodies must agree to conduct for-cause inspections
upon the request of SAMHSA.
(3) Accreditation decisions shall be fully consistent with the
policies and procedures submitted as part of the approved accreditation
body application.
(b) Response to noncompliant programs. (1) If an accreditation body
receives or discovers information that suggests
[[Page 92]]
that an OTP is not meeting Federal opioid treatment standards, or if
survey of the OTP by the accreditation body otherwise demonstrates one
or more deficiencies in the OTP, the accreditation body shall as
appropriate either require and monitor corrective action or shall
suspend or revoke accreditation of the OTP, as appropriate based on the
significance of the deficiencies.
(i) Accreditation bodies shall either not accredit or shall revoke
the accreditation of any OTP that substantially fails to meet the
Federal opioid treatment standards.
(ii) Accreditation bodies shall notify SAMHSA as soon as possible
but in no case longer than 48 hours after becoming aware of any practice
or condition in an OTP that may pose a serious risk to public health or
safety or patient care.
(iii) If an accreditation body determines that an OTP is
substantially meeting the Federal opioid treatment standards, but is not
meeting one or more accreditation elements, the accreditation body shall
determine the necessary corrective measures to be taken by the OTP,
establish a schedule for implementation of such measures, and notify the
OTP in writing that it must implement such measures within the specified
schedule in order to ensure continued accreditation. The accreditation
body shall verify that the necessary steps are taken by the OTP within
the schedule specified and that all accreditation elements are being
substantially met or will be substantially met.
(2) Nothing in this part shall prevent accreditation bodies from
granting accreditation, contingent on promised programmatic or
performance changes, to OTPs with less substantial violations. Such
accreditation shall not exceed 12 months. OTPs that have been granted
such accreditation must have their accreditation revoked if they fail to
make changes to receive unconditional accreditation upon resurvey or
reinspection.
(c) Recordkeeping. (1) Accreditation bodies shall maintain records
of their accreditation activities for at least 5 years from the creation
of the record. Such records must contain sufficient detail to support
each accreditation decision made by the accreditation body.
(2) Accreditation bodies shall establish procedures to protect
confidential information collected or received in their role as
accreditation bodies that are consistent with, and that are designed to
ensure compliance with, all Federal and State laws, including 42 CFR
part 2.
(i) Information collected or received for the purpose of carrying
out accreditation body responsibilities shall not be used for any other
purpose or disclosed, other than to SAMHSA or its duly designated
representatives, unless otherwise required by law or with the consent of
the OTP.
(ii) Nonpublic information that SAMHSA shares with the accreditation
body concerning an OTP shall not be further disclosed except with the
written permission of SAMHSA.
(d) Reporting. (1) Accreditation bodies shall provide to SAMHSA any
documents and information requested by SAMHSA within 5 days of receipt
of the request.
(2) Accreditation bodies shall make a summary of the results of each
accreditation survey available to SAMHSA upon request. Such summaries
shall contain sufficient detail to justify the accreditation action
taken.
(3) Accreditation bodies shall provide SAMHSA upon request a list of
each OTP surveyed and the identity of all individuals involved in the
conduct and reporting of survey results.
(4) Accreditation bodies shall submit to SAMHSA the name of each OTP
for which the accreditation body accredits conditionally, denies,
suspends, or revokes accreditation, and the basis for the action, within
48 hours of the action.
(5) Notwithstanding any reports made to SAMHSA under paragraphs
(d)(1) through (d)(4) of this section, each accreditation body shall
submit to SAMHSA semiannually, on January 15 and July 15 of each
calendar year, a report consisting of a summary of the results of each
accreditation survey conducted in the past year. The summary shall
contain sufficient detail to justify each accreditation action taken.
[[Page 93]]
(6) All reporting requirements listed in this section shall be
provided to SAMHSA at the address specified in Sec. 8.3(b).
(e) Complaint response. Accreditation bodies shall have policies and
procedures to respond to complaints from SAMHSA, patients, facility
staff, and others, within a reasonable period of time but not more than
5 days of the receipt of the complaint. Accreditation bodies shall also
agree to notify SAMHSA within 48 hours of receipt of a complaint and
keep SAMHSA informed of all aspects of the response to the complaint.
(f) Modifications of accreditation elements. Accreditation bodies
shall obtain SAMHSA's authorization prior to making any substantive
(i.e., noneditorial) change in accreditation elements.
(g) Conflicts of interest. The accreditation body shall maintain and
apply policies and procedures that SAMHSA has approved in accordance
with Sec. 8.3 to reduce the possibility of actual conflict of interest,
or the appearance of a conflict of interest, on the part of individuals
who act on behalf of the accreditation body. Individuals who participate
in accreditation surveys or otherwise participate in the accreditation
decision or an appeal of the accreditation decision, as well as their
spouses and minor children, shall not have a financial interest in the
OTP that is the subject of the accreditation survey or decision.
(h) Accreditation teams. (1) An accreditation body survey team shall
consist of healthcare professionals with expertise in drug abuse
treatment and, in particular, opioid treatment. The accreditation body
shall consider factors such as the size of the OTP, the anticipated
number of problems, and the OTP's accreditation history, in determining
the composition of the team. At a minimum, survey teams shall consist of
at least two healthcare professionals whose combined expertise includes:
(i) The dispensing and administration of drugs subject to control
under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(ii) Medical issues relating to the dosing and administration of
opioid agonist treatment medications for the treatment of opioid
addiction;
(iii) Psychosocial counseling of individuals undergoing opioid
treatment; and
(iv) Organizational and administrative issues associated with opioid
treatment programs.
(2) Members of the accreditation team must be able to recuse
themselves at any time from any survey in which either they or the OTP
believes there is an actual conflict of interest or the appearance of a
conflict of interest.
(i) Accreditation fees. Fees charged to OTPs for accreditation shall
be reasonable. SAMHSA generally will find fees to be reasonable if the
fees are limited to recovering costs to the accreditation body,
including overhead incurred. Accreditation body activities that are not
related to accreditation functions are not recoverable through fees
established for accreditation.
(1) The accreditation body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different OTPs.
(2) At SAMHSA's request, accreditation bodies shall provide to
SAMHSA financial records or other materials, in a manner specified by
SAMHSA, to assist in assessing the reasonableness of accreditation body
fees.
Sec. 8.5 Periodic evaluation of accreditation bodies.
SAMHSA will evaluate periodically the performance of accreditation
bodies primarily by inspecting a selected sample of the OTPs accredited
by the accrediting body and by evaluating the accreditation body's
reports of surveys conducted, to determine whether the OTPs surveyed and
accredited by the accreditation body are in compliance with the Federal
opioid treatment standards. The evaluation will include a determination
of whether there are major deficiencies in the accreditation body's
performance that, if not corrected, would warrant withdrawal of the
approval of the accreditation body under Sec. 8.6.
[[Page 94]]
Sec. 8.6 Withdrawal of approval of accreditation bodies.
If SAMHSA determines that an accreditation body is not in
substantial compliance with this subpart, SAMHSA shall take appropriate
action as follows:
(a) Major deficiencies. If SAMHSA determines that the accreditation
body has a major deficiency, such as commission of fraud, material false
statement, failure to perform a major accreditation function
satisfactorily, or significant noncompliance with the requirements of
this subpart, SAMHSA shall withdraw approval of that accreditation body.
(1) In the event of a major deficiency, SAMHSA shall notify the
accreditation body of the agency's action and the grounds on which the
approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify
each OTP that has been accredited or is seeking accreditation that the
accreditation body's approval has been withdrawn. Such notification
shall be made within a time period and in a manner approved by SAMHSA.
(b) Minor deficiencies. If SAMHSA determines that the accreditation
body has minor deficiencies in the performance of an accreditation
function, that are less serious or more limited than the types of
deficiencies described in paragraph (a) of this section, SAMHSA will
notify the body that it has 90 days to submit to SAMHSA a plan of
corrective action. The plan must include a summary of corrective actions
and a schedule for their implementation. SAMHSA may place the body on
probationary status for a period of time determined by SAMHSA, or may
withdraw approval of the body if corrective action is not taken.
(1) If SAMHSA places an accreditation body on probationary status,
the body shall notify all OTPs that have been accredited, or that are
seeking accreditation, of the accreditation body's probationary status
within a time period and in a manner approved by SAMHSA.
(2) Probationary status will remain in effect until such time as the
body can demonstrate to the satisfaction of SAMHSA that it has
successfully implemented or is implementing the corrective action plan
within the established schedule, and the corrective actions taken have
substantially eliminated all identified problems.
(3) If SAMHSA determines that an accreditation body that has been
placed on probationary status is not implementing corrective actions
satisfactorily or within the established schedule, SAMHSA may withdraw
approval of the accreditation body. The accreditation body shall notify
all OTPs that have been accredited, or are seeking accreditation, of the
accreditation body's loss of SAMHSA approval within a time period and in
a manner approved by SAMHSA.
(c) Reapplication. (1) An accreditation body that has had its
approval withdrawn may submit a new application for approval if the body
can provide information to SAMHSA to establish that the problems that
were grounds for withdrawal of approval have been resolved.
(2) If SAMHSA determines that the new application demonstrates that
the body satisfactorily has addressed the causes of its previous
unacceptable performance, SAMHSA may reinstate approval of the
accreditation body.
(3) SAMHSA may request additional information or establish
additional conditions that must be met before SAMHSA approves the
reapplication.
(4) SAMHSA may refuse to accept an application from a former
accreditation body whose approval was withdrawn because of fraud,
material false statement, or willful disregard of public health.
(d) Hearings. An opportunity to challenge an adverse action taken
regarding withdrawal of approval of an accreditation body shall be
addressed through the relevant procedures set forth in subpart C of this
part, except that the procedures in Sec. 8.28 for expedited review of
an immediate suspension would not apply to an accreditation body that
has been notified under paragraph (a) or (b) of this section of the
withdrawal of its approval.
[[Page 95]]
Subpart B_Certification and Treatment Standards
Sec. 8.11 Opioid treatment program certification.
(a) General. (1) An OTP must be the subject of a current, valid
certification from SAMHSA to be considered qualified by the Secretary
under section 303(g)(1) of the Controlled Substances Act (21 U.S.C.
823(g)(1)) to dispense opioid drugs in the treatment of opioid
addiction. An OTP must be determined to be qualified under section
303(g)(1) of the Controlled Substances Act, and must be determined to be
qualified by the Attorney General under section 303(g)(1), to be
registered by the Attorney General to dispense opioid agonist treatment
medications to individuals for treatment of opioid addiction.
(2) To obtain certification from SAMHSA, an OTP must meet the
Federal opioid treatment standards in Sec. 8.12, must be the subject of
a current, valid accreditation by an accreditation body or other entity
designated by SAMHSA, and must comply with any other conditions for
certification established by SAMHSA.
(3) Certification shall be granted for a term not to exceed 3 years,
except that certification may be extended during the third year if an
application for accreditation is pending.
(b) Application for certification. Three copies of an application
for certification must be submitted by the OTP to the address identified
in Sec. 8.3(b). SAMHSA will consider and accept the electronic
submission of these materials when electronic submission systems are
developed and available. The application for certification shall
include:
(1) A description of the current accreditation status of the OTP;
(2) A description of the organizational structure of the OTP;
(3) The names of the persons responsible for the OTP;
(4) The addresses of the OTP and of each medication unit or other
facility under the control of the OTP;
(5) The sources of funding for the OTP and the name and address of
each governmental entity that provides such funding; and
(6) A statement that the OTP will comply with the conditions of
certification set forth in paragraph (f) of this section.
(7) The application shall be signed by the program sponsor who shall
certify that the information submitted in the application is truthful
and accurate.
(c) Action on application. (1) Following SAMHSA's receipt of an
application for certification of an OTP, and after consultation with the
appropriate State authority regarding the qualifications of the
applicant, SAMHSA may grant the application for certification, or renew
an existing certification, if SAMHSA determines that the OTP has
satisfied the requirements for certification or renewal of
certification.
(2) SAMHSA may deny the application if SAMHSA determines that:
(i) The application for certification is deficient in any respect;
(ii) The OTP will not be operated in accordance with the Federal
opioid treatment standards established under Sec. 8.12;
(iii) The OTP will not permit an inspection or a survey to proceed,
or will not permit in a timely manner access to relevant records or
information; or
(iv) The OTP has made misrepresentations in obtaining accreditation
or in applying for certification.
(3) Within 5 days after it reaches a final determination that an OTP
meets the requirements for certification, SAMHSA will notify the Drug
Enforcement Administration (DEA) that the OTP has been determined to be
qualified to provide opioid treatment under section 303(g)(1) of the
Controlled Substances Act.
(d) Transitional certification. OTPs that before May 18, 2001 were
the subject of a current, valid approval by FDA under 21 CFR, part 291
(contained in the 21 CFR parts 200 to 299 edition, revised as of July 1,
2000), are deemed to be the subject of a current valid certification for
purposes of paragraph (a)(11) of this section. Such ``transitional
certification'' will expire on August 17, 2001 unless the OTP submits
the information required by paragraph (b) of this section to SAMHSA on
or before August 17, 2001. In addition to this application, OTPs must
certify with a
[[Page 96]]
written statement signed by the program sponsor, that they will apply
for accreditation within 90 days of the date SAMHSA approves the second
accreditation body. Transitional certification, in that case, will
expire on May 19, 2003. SAMHSA may extend the transitional certification
of an OTP for up to one additional year provided the OTP demonstrates
that it has applied for accreditation, that an accreditation survey has
taken place or is scheduled to take place, and that an accreditation
decision is expected within a reasonable period of time (e.g., within 90
days from the date of survey). Transitional certification under this
section may be suspended or revoked in accordance with Sec. 8.14.
(e) Provisional certification. (1) OTPs that have no current
certification from SAMHSA, but have applied for accreditation with an
accreditation body, are eligible to receive a provisional certification
for up to 1 year. To receive a provisional certification, an OTP shall
submit the information required by paragraph (b) of this section to
SAMHSA along with a statement identifying the accreditation body to
which the OTP has applied for accreditation, the date on which the OTP
applied for accreditation, the dates of any accreditation surveys that
have taken place or are expected to take place, and the expected
schedule for completing the accreditation process. A provisional
certification for up to 1 year will be granted, following receipt of the
information described in this paragraph, unless SAMHSA determines that
patient health would be adversely affected by the granting of
provisional certification.
(2) An extension of provisional certification may be granted in
extraordinary circumstances or otherwise to protect public health. To
apply for a 90-day extension of provisional certification, an OTP shall
submit to SAMHSA a statement explaining its efforts to obtain
accreditation and a schedule for obtaining accreditation as
expeditiously as possible.
(f) Conditions for certification. (1) OTPs shall comply with all
pertinent State laws and regulations. Nothing in this part is intended
to limit the authority of State and, as appropriate, local governmental
entities to regulate the use of opioid drugs in the treatment of opioid
addiction. The provisions of this section requiring compliance with
requirements imposed by State law, or the submission of applications or
reports required by the State authority, do not apply to OTPs operated
directly by the Department of Veterans Affairs, the Indian Health
Service, or any other department or agency of the United States. Federal
agencies operating OTPs have agreed to cooperate voluntarily with State
agencies by granting permission on an informal basis for designated
State representatives to visit Federal OTPs and by furnishing a copy of
Federal reports to the State authority, including the reports required
under this section.
(2) OTPs shall allow, in accordance with Federal controlled
substances laws and Federal confidentiality laws, inspections and
surveys by duly authorized employees of SAMHSA, by accreditation bodies,
by the DEA, and by authorized employees of any relevant State or Federal
governmental authority.
(3) Disclosure of patient records maintained by an OTP is governed
by the provisions of 42 CFR part 2, and every program must comply with
that part. Records on the receipt, storage, and distribution of opioid
agonist treatment medications are also subject to inspection under
Federal controlled substances laws and under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 et seq.). Federally-sponsored treatment
programs are subject to applicable Federal confidentiality statutes.
(4) A treatment program or medication unit or any part thereof,
including any facility or any individual, shall permit a duly authorized
employee of SAMHSA to have access to and to copy all records on the use
of opioid drugs in accordance with the provisions of 42 CFR part 2.
(5) OTPs shall notify SAMHSA within 3 weeks of any replacement or
other change in the status of the program sponsor or medical director.
(6) OTPs shall comply with all regulations enforced by the DEA under
21 CFR chapter II, and must be registered by the DEA before
administering or
[[Page 97]]
dispensing opioid agonist treatment medications.
(7) OTPs must operate in accordance with Federal opioid treatment
standards and approved accreditation elements.
(g) Conditions for interim maintenance treatment program approval.
(1) Before a public or nonprofit private OTP may provide interim
maintenance treatment, the program must receive the approval of both
SAMHSA and the chief public health officer of the State in which the OTP
operates.
(2) Before SAMHSA may grant such approval, the OTP must provide
SAMHSA with documentation from the chief public health officer of the
State in which the OTP operates demonstrating that:
(i) Such officer does not object to the providing of interim
maintenance treatment in the State;
(ii) The OTP seeking to provide such treatment is unable to place
patients in a public or nonprofit private comprehensive treatment
program within a reasonable geographic area within 14 days of the time
patients seek admission to such programs;
(iii) The authorization of the OTP to provide interim maintenance
treatment will not otherwise reduce the capacity of comprehensive
maintenance treatment programs in the State to admit individuals
(relative to the date on which such officer so certifies); and
(iv) The State certifies that each individual enrolled in interim
maintenance treatment will be transferred to a comprehensive maintenance
treatment program no later than 120 days from the date on which each
individual first requested treatment, as provided in section 1923 of the
Public Health Service Act (21 U.S.C. 300x-23).
(3) SAMHSA will provide notice to the OTP denying or approving the
request to provide interim maintenance treatment. The OTP shall not
provide such treatment until it has received such notice from SAMHSA.
(h) Exemptions. An OTP may, at the time of application for
certification or any time thereafter, request from SAMHSA exemption from
the regulatory requirements set forth under this section and Sec. 8.12.
An example of a case in which an exemption might be granted would be for
a private practitioner who wishes to treat a limited number of patients
in a non-metropolitan area with few physicians and no rehabilitative
services geographically accessible and requests exemption from some of
the staffing and service standards. The OTP shall support the rationale
for the exemption with thorough documentation, to be supplied in an
appendix to the initial application for certification or in a separate
submission. SAMHSA will approve or deny such exemptions at the time of
application, or any time thereafter, if appropriate. SAMHSA shall
consult with the appropriate State authority prior to taking action on
an exemption request.
(i) Medication units, long-term care facilities and hospitals. (1)
Certified OTPs may establish medication units that are authorized to
dispense opioid agonist treatment medications for observed ingestion.
Before establishing a medication unit, a certified OTP must notify
SAMHSA by submitting form SMA-162. The OTP must also comply with the
provisions of 21 CFR part 1300 before establishing a medication unit.
Medication units shall comply with all pertinent state laws and
regulations.
(2) Certification as an OTP under this part will not be required for
the maintenance or detoxification treatment of a patient who is admitted
to a hospital or long-term care facility for the treatment of medical
conditions other than opiate addiction and who requires maintenance or
detoxification treatment during the period of his or her stay in that
hospital or long-term care facility. The terms ``hospital'' and ``long-
term care facility'' as used in this section are to have the meaning
that is assigned under the law of the State in which the treatment is
being provided. Nothing in this section is intended to relieve hospitals
and long-term care facilities from the obligation to obtain registration
from the Attorney General, as appropriate, under section 303(g) of the
Controlled Substances Act.
[66 FR 4090, Jan. 17, 2001, as amended at 66 FR 15347, Mar. 19, 2001]
[[Page 98]]
Sec. 8.12 Federal opioid treatment standards.
(a) General. OTPs must provide treatment in accordance with the
standards in this section and must comply with these standards as a
condition of certification.
(b) Administrative and organizational structure. An OTP's
organizational structure and facilities shall be adequate to ensure
quality patient care and to meet the requirements of all pertinent
Federal, State, and local laws and regulations. At a minimum, each OTP
shall formally designate a program sponsor and medical director. The
program sponsor shall agree on behalf of the OTP to adhere to all
requirements set forth in this part and any regulations regarding the
use of opioid agonist treatment medications in the treatment of opioid
addiction which may be promulgated in the future. The medical director
shall assume responsibility for administering all medical services
performed by the OTP. In addition, the medical director shall be
responsible for ensuring that the OTP is in compliance with all
applicable Federal, State, and local laws and regulations.
(c) Continuous quality improvement. (1) An OTP must maintain current
quality assurance and quality control plans that include, among other
things, annual reviews of program policies and procedures and ongoing
assessment of patient outcomes.
(2) An OTP must maintain a current ``Diversion Control Plan'' or
``DCP'' as part of its quality assurance program that contains specific
measures to reduce the possibility of diversion of controlled substances
from legitimate treatment use and that assigns specific responsibility
to the medical and administrative staff of the OTP for carrying out the
diversion control measures and functions described in the DCP.
(d) Staff credentials. Each person engaged in the treatment of
opioid addiction must have sufficient education, training, and
experience, or any combination thereof, to enable that person to perform
the assigned functions. All physicians, nurses, and other licensed
professional care providers, including addiction counselors, must comply
with the credentialing requirements of their respective professions.
(e) Patient admission criteria--(1) Maintenance treatment. An OTP
shall maintain current procedures designed to ensure that patients are
admitted to maintenance treatment by qualified personnel who have
determined, using accepted medical criteria such as those listed in the
Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that
the person is currently addicted to an opioid drug, and that the person
became addicted at least 1 year before admission for treatment. In
addition, a program physician shall ensure that each patient voluntarily
chooses maintenance treatment and that all relevant facts concerning the
use of the opioid drug are clearly and adequately explained to the
patient, and that each patient provides informed written consent to
treatment.
(2) Maintenance treatment for persons under age 18. A person under
18 years of age is required to have had two documented unsuccessful
attempts at short-term detoxification or drug-free treatment within a
12-month period to be eligible for maintenance treatment. No person
under 18 years of age may be admitted to maintenance treatment unless a
parent, legal guardian, or responsible adult designated by the relevant
State authority consents in writing to such treatment.
(3) Maintenance treatment admission exceptions. If clinically
appropriate, the program physician may waive the requirement of a 1-year
history of addiction under paragraph (e)(1) of this section, for
patients released from penal institutions (within 6 months after
release), for pregnant patients (program physician must certify
pregnancy), and for previously treated patients (up to 2 years after
discharge).
(4) Detoxification treatment. An OTP shall maintain current
procedures that are designed to ensure that patients are admitted to
short- or long-term detoxification treatment by qualified personnel,
such as a program physician, who determines that such treatment is
appropriate for the specific patient by applying established diagnostic
criteria. Patients with two or more unsuccessful detoxification episodes
within a 12-month period must be
[[Page 99]]
assessed by the OTP physician for other forms of treatment. A program
shall not admit a patient for more than two detoxification treatment
episodes in one year.
(f) Required services.(1) General. OTPs shall provide adequate
medical, counseling, vocational, educational, and other assessment and
treatment services. These services must be available at the primary
facility, except where the program sponsor has entered into a formal,
documented agreement with a private or public agency, organization,
practitioner, or institution to provide these services to patients
enrolled in the OTP. The program sponsor, in any event, must be able to
document that these services are fully and reasonably available to
patients.
(2) Initial medical examination services. OTPs shall require each
patient to undergo a complete, fully documented physical evaluation by a
program physician or a primary care physician, or an authorized
healthcare professional under the supervision of a program physician,
before admission to the OTP. The full medical examination, including the
results of serology and other tests, must be completed within 14 days
following admission.
(3) Special services for pregnant patients. OTPs must maintain
current policies and procedures that reflect the special needs of
patients who are pregnant. Prenatal care and other gender specific
services or pregnant patients must be provided either by the OTP or by
referral to appropriate healthcare providers.
(4) Initial and periodic assessment services. Each patient accepted
for treatment at an OTP shall be assessed initially and periodically by
qualified personnel to determine the most appropriate combination of
services and treatment. The initial assessment must include preparation
of a treatment plan that includes the patient's short-term goals and the
tasks the patient must perform to complete the short-term goals; the
patient's requirements for education, vocational rehabilitation, and
employment; and the medical, psychosocial, economic, legal, or other
supportive services that a patient needs. The treatment plan also must
identify the frequency with which these services are to be provided. The
plan must be reviewed and updated to reflect that patient's personal
history, his or her current needs for medical, social, and psychological
services, and his or her current needs for education, vocational
rehabilitation, and employment services.
(5) Counseling services. (i) OTPs must provide adequate substance
abuse counseling to each patient as clinically necessary. This
counseling shall be provided by a program counselor, qualified by
education, training, or experience to assess the psychological and
sociological background of patients, to contribute to the appropriate
treatment plan for the patient and to monitor patient progress.
(ii) OTPs must provide counseling on preventing exposure to, and the
transmission of, human immunodeficiency virus (HIV) disease for each
patient admitted or readmitted to maintenance or detoxification
treatment.
(iii) OTPs must provide directly, or through referral to adequate
and reasonably accessible community resources, vocational
rehabilitation, education, and employment services for patients who
either request such services or who have been determined by the program
staff to be in need of such services.
(6) Drug abuse testing services. OTPs must provide adequate testing
or analysis for drugs of abuse, including at least eight random drug
abuse tests per year, per patient in maintenance treatment, in
accordance with generally accepted clinical practice. For patients in
short-term detoxification treatment, the OTP shall perform at least one
initial drug abuse test. For patients receiving long-term detoxification
treatment, the program shall perform initial and monthly random tests on
each patient.
(g) Recordkeeping and patient confidentiality. (1) OTPs shall
establish and maintain a recordkeeping system that is adequate to
document and monitor patient care. This system is required to comply
with all Federal and State reporting requirements relevant to opioid
drugs approved for use in treatment of opioid addiction. All records are
required to be kept confidential in
[[Page 100]]
accordance with all applicable Federal and State requirements.
(2) OTPs shall include, as an essential part of the recordkeeping
system, documentation in each patient's record that the OTP made a good
faith effort to review whether or not the patient is enrolled any other
OTP. A patient enrolled in an OTP shall not be permitted to obtain
treatment in any other OTP except in exceptional circumstances. If the
medical director or program physician of the OTP in which the patient is
enrolled determines that such exceptional circumstances exist, the
patient may be granted permission to seek treatment at another OTP,
provided the justification for finding exceptional circumstances is
noted in the patient's record both at the OTP in which the patient is
enrolled and at the OTP that will provide the treatment.
(h) Medication administration, dispensing, and use. (1) OTPs must
ensure that opioid agonist treatment medications are administered or
dispensed only by a practitioner licensed under the appropriate State
law and registered under the appropriate State and Federal laws to
administer or dispense opioid drugs, or by an agent of such a
practitioner, supervised by and under the order of the licensed
practitioner. This agent is required to be a pharmacist, registered
nurse, or licensed practical nurse, or any other healthcare professional
authorized by Federal and State law to administer or dispense opioid
drugs.
(2) OTPs shall use only those opioid agonist treatment medications
that are approved by the Food and Drug Administration under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in
the treatment of opioid addiction. In addition, OTPs who are fully
compliant with the protocol of an investigational use of a drug and
other conditions set forth in the application may administer a drug that
has been authorized by the Food and Drug Administration under an
investigational new drug application under section 505(i) of the Federal
Food, Drug, and Cosmetic Act for investigational use in the treatment of
opioid addiction. Currently the following opioid agonist treatment
medications will be considered to be approved by the Food and Drug
Administration for use in the treatment of opioid addiction:
(i) Methadone;
(ii) Levomethadyl acetate (LAAM); and
(iii) Buprenorphine and buprenorphine combination products that have
been approved for use in the treatment of opioid addiction.
(3) OTPs shall maintain current procedures that are adequate to
ensure that the following dosage form and initial dosing requirements
are met:
(i) Methadone shall be administered or dispensed only in oral form
and shall be formulated in such a way as to reduce its potential for
parenteral abuse.
(ii) For each new patient enrolled in a program, the initial dose of
methadone shall not exceed 30 milligrams and the total dose for the
first day shall not exceed 40 milligrams, unless the program physician
documents in the patient's record that 40 milligrams did not suppress
opiate abstinence symptoms.
(4) OTPs shall maintain current procedures adequate to ensure that
each opioid agonist treatment medication used by the program is
administered and dispensed in accordance with its approved product
labeling. Dosing and administration decisions shall be made by a program
physician familiar with the most up-to-date product labeling. These
procedures must ensure that any significant deviations from the approved
labeling, including deviations with regard to dose, frequency, or the
conditions of use described in the approved labeling, are specifically
documented in the patient's record.
(i) Unsupervised or ``take-home'' use. To limit the potential for
diversion of opioid agonist treatment medications to the illicit market,
opioid agonist treatment medications dispensed to patients for
unsupervised use shall be subject to the following requirements.
(1) Any patient in comprehensive maintenance treatment may receive a
single take-home dose for a day that the clinic is closed for business,
including Sundays and State and Federal holidays.
(2) Treatment program decisions on dispensing opioid treatment
medications to patients for unsupervised use
[[Page 101]]
beyond that set forth in paragraph (i)(1) of this section, shall be
determined by the medical director. In determining which patients may be
permitted unsupervised use, the medical director shall consider the
following take-home criteria in determining whether a patient is
responsible in handling opioid drugs for unsupervised use.
(i) Absence of recent abuse of drugs (opioid or nonnarcotic),
including alcohol;
(ii) Regularity of clinic attendance;
(iii) Absence of serious behavioral problems at the clinic;
(iv) Absence of known recent criminal activity, e.g., drug dealing;
(v) Stability of the patient's home environment and social
relationships;
(vi) Length of time in comprehensive maintenance treatment;
(vii) Assurance that take-home medication can be safely stored
within the patient's home; and
(viii) Whether the rehabilitative benefit the patient derived from
decreasing the frequency of clinic attendance outweighs the potential
risks of diversion.
(3) Such determinations and the basis for such determinations
consistent with the criteria outlined in paragraph (i)(2) of this
section shall be documented in the patient's medical record. If it is
determined that a patient is responsible in handling opioid drugs, the
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi)
of this section apply. The dispensing restrictions set forth in
paragraphs (i)(3)(i) through (vi) of this section do not apply to
buprenorphine and buprenorphine products listed under paragraph
(h)(2)(iii) of this section.
(4) No medications shall be dispensed to patients in short-term
detoxification treatment or interim maintenance treatment for
unsupervised or take-home use.
(5) OTPs must maintain current procedures adequate to identify the
theft or diversion of take-home medications, including labeling
containers with the OTP's name, address, and telephone number. Programs
also must ensure that take-home supplies are packaged in a manner that
is designed to reduce the risk of accidental ingestion, including child-
proof containers (see Poison Prevention Packaging Act, Public Law 91-601
(15 U.S.C. 1471 et seq.)).
(j) Interim maintenance treatment. (1) The program sponsor of a
public or nonprofit private OTP may place an individual, who is eligible
for admission to comprehensive maintenance treatment, in interim
maintenance treatment if the individual cannot be placed in a public or
nonprofit private comprehensive program within a reasonable geographic
area and within 14 days of the individual's application for admission to
comprehensive maintenance treatment. An initial and at least two other
urine screens shall be taken from interim patients during the maximum of
120 days permitted for such treatment. A program shall establish and
follow reasonable criteria for establishing priorities for transferring
patients from interim maintenance to comprehensive maintenance
treatment. These transfer criteria shall be in writing and shall
include, at a minimum, a preference for pregnant women in admitting
patients to interim maintenance and in transferring patients from
interim maintenance to comprehensive maintenance treatment. Interim
maintenance shall be provided in a manner consistent with all applicable
Federal and State laws, including sections 1923, 1927(a), and 1976 of
the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-
11).
(2) The program shall notify the State health officer when a patient
begins interim maintenance treatment, when a patient leaves interim
maintenance treatment, and before the date of mandatory transfer to a
comprehensive program, and shall document such notifications.
(3) SAMHSA may revoke the interim maintenance authorization for
programs that fail to comply with the provisions of this paragraph (j).
Likewise, SAMHSA will consider revoking the interim maintenance
authorization of a program if the State in which the program operates is
not in compliance with the provisions of Sec. 8.11(g).
(4) All requirements for comprehensive maintenance treatment apply
to interim maintenance treatment with the following exceptions:
[[Page 102]]
(i) The opioid agonist treatment medication is required to be
administered daily under observation;
(ii) Unsupervised or ``take-home'' use is not allowed;
(iii) An initial treatment plan and periodic treatment plan
evaluations are not required;
(iv) A primary counselor is not required to be assigned to the
patient;
(v) Interim maintenance cannot be provided for longer than 120 days
in any 12-month period; and
(vi) Rehabilitative, education, and other counseling services
described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this
section are not required to be provided to the patient.
[66 FR 4090, Jan. 17, 2001, as amended at 68 FR 27939, May 22, 2003; 77
FR 72761, Dec. 6, 2012]
Sec. 8.13 Revocation of accreditation and accreditation body approval.
(a) SAMHSA action following revocation of accreditation. If an
accreditation body revokes an OTP's accreditation, SAMHSA may conduct an
investigation into the reasons for the revocation. Following such
investigation, SAMHSA may determine that the OTP's certification should
no longer be in effect, at which time SAMHSA will initiate procedures to
revoke the facility's certification in accordance with Sec. 8.14.
Alternatively, SAMHSA may determine that another action or combination
of actions would better serve the public health, including the
establishment and implementation of a corrective plan of action that
will permit the certification to continue in effect while the OTP seeks
reaccreditation.
(b) Accreditation body approval. (1) If SAMHSA withdraws the
approval of an accreditation body under Sec. 8.6, the certifications of
OTPs accredited by such body shall remain in effect for a period of 1
year after the date of withdrawal of approval of the accreditation body,
unless SAMHSA determines that to protect public health or safety, or
because the accreditation body fraudulently accredited treatment
programs, the certifications of some or all of the programs should be
revoked or suspended or that a shorter time period should be established
for the certifications to remain in effect. SAMHSA may extend the time
in which a certification remains in effect under this paragraph on a
case-by-case basis.
(2) Within 1 year from the date of withdrawal of approval of an
accreditation body, or within any shorter period of time established by
SAMHSA, OTPs currently accredited by the accreditation body must obtain
accreditation from another accreditation body. SAMHSA may extend the
time period for obtaining reaccreditation on a case-by-case basis.
Sec. 8.14 Suspension or revocation of certification.
(a) Revocation. Except as provided in paragraph (b) of this section,
SAMHSA may revoke the certification of an OTP if SAMHSA finds, after
providing the program sponsor with notice and an opportunity for a
hearing in accordance with subpart C of this part, that the program
sponsor, or any employee of the OTP:
(1) Has been found guilty of misrepresentation in obtaining the
certification;
(2) Has failed to comply with the Federal opioid treatment standards
in any respect;
(3) Has failed to comply with reasonable requests from SAMHSA or
from an accreditation body for records, information, reports, or
materials that are necessary to determine the continued eligibility of
the OTP for certification or continued compliance with the Federal
opioid treatment standards; or
(4) Has refused a reasonable request of a duly designated SAMHSA
inspector, Drug Enforcement Administration (DEA) Inspector, State
Inspector, or accreditation body representative for permission to
inspect the program or the program's operations or its records.
(b) Suspension. Whenever SAMHSA has reason to believe that
revocation may be required and that immediate action is necessary to
protect public health or safety, SAMHSA may immediately suspend the
certification of an OTP before holding a hearing under subpart C of this
part. SAMHSA may immediately suspend as well as propose revocation of
the certification of an OTP before holding a hearing under subpart C of
this part if SAMHSA makes a finding described in paragraph
[[Page 103]]
(a) of this section and also determines that:
(1) The failure to comply with the Federal opioid treatment
standards presents an imminent danger to the public health or safety;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the failure to comply with the
Federal opioid treatment standards was intentional or was associated
with fraud.
(c) Written notification. In the event that SAMHSA suspends the
certification of an OTP in accordance with paragraph (b) of this section
or proposes to revoke the certification of an OTP in accordance with
paragraph (a) of this section, SAMHSA shall promptly provide the sponsor
of the OTP with written notice of the suspension or proposed revocation
by facsimile transmission, personal service, commercial overnight
delivery service, or certified mail, return receipt requested. Such
notice shall state the reasons for the action and shall state that the
OTP may seek review of the action in accordance with the procedures in
subpart C of this part.
(d)(1) If SAMHSA suspends certification in accordance with paragraph
(b) of this section:
(i) SAMHSA will immediately notify DEA that the OTP's registration
should be suspended under 21 U.S.C. 824(d); and
(ii) SAMHSA will provide an opportunity for a hearing under subpart
C of this part.
(2) Suspension of certification under paragraph (b) of this section
shall remain in effect until the agency determines that:
(i) The basis for the suspension cannot be substantiated;
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The OTP's certification shall be revoked.
Sec. 8.15 Forms.
(a) SMA-162--Application for Certification to Use Opioid Agonist
Treatment Medications for Opioid Treatment.
(b) SMA-163--Application for Becoming an Accreditation Body under
Sec. 8.3.
Subpart C_Procedures for Review of Suspension or Proposed Revocation of
OTP Certification, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
Sec. 8.21 Applicability.
The procedures in this subpart apply when:
(a) SAMHSA has notified an OTP in writing that its certification
under the regulations in subpart B of this part has been suspended or
that SAMHSA proposes to revoke the certification; and
(b) The OTP has, within 30 days of the date of the notification or
within 3 days of the date of the notification when seeking an expedited
review of a suspension, requested in writing an opportunity for a review
of the suspension or proposed revocation.
(c) SAMHSA has notified an accreditation body of an adverse action
taken regarding withdrawal of approval of the accreditation body under
the regulations in subpart A of this part; and
(d) The accreditation body has, within 30 days of the date of the
notification, requested in writing an opportunity for a review of the
adverse action.
Sec. 8.22 Definitions.
The following definitions apply to this subpart C.
(a) Appellant means:
(1) The treatment program which has been notified of its suspension
or proposed revocation of its certification under the regulations of
this part and has requested a review of the suspension or proposed
revocation, or
(2) The accreditation body which has been notified of adverse action
regarding withdrawal of approval under the regulations of this subpart
and has requested a review of the adverse action.
(b) Respondent means SAMHSA.
(c) Reviewing official means the person or persons designated by the
Secretary who will review the suspension or proposed revocation. The
reviewing
[[Page 104]]
official may be assisted by one or more HHS officers or employees or
consultants in assessing and weighing the scientific and technical
evidence and other information submitted by the appellant and respondent
on the reasons for the suspension and proposed revocation.
Sec. 8.23 Limitation on issues subject to review.
The scope of review shall be limited to the facts relevant to any
suspension, or proposed revocation, or adverse action, the necessary
interpretations of the facts the regulations, in the subpart, and other
relevant law.
Sec. 8.24 Specifying who represents the parties.
The appellant's request for review shall specify the name, address,
and phone number of the appellant's representative. In its first written
submission to the reviewing official, the respondent shall specify the
name, address, and phone number of the respondent's representative.
Sec. 8.25 Informal review and the reviewing official's response.
(a) Request for review. Within 30 days of the date of the notice of
the suspension or proposed revocation, the appellant must submit a
written request to the reviewing official seeking review, unless some
other time period is agreed to by the parties. A copy must also be sent
to the respondent. The request for review must include a copy of the
notice of suspension, proposed revocation, or adverse action, a brief
statement of why the decision to suspend, propose revocation, or take an
adverse action is incorrect, and the appellant's request for an oral
presentation, if desired.
(b) Acknowledgment. Within 5 days after receiving the request for
review, the reviewing official will send an acknowledgment and advise
the appellant of the next steps. The reviewing official will also send a
copy of the acknowledgment to the respondent.
Sec. 8.26 Preparation of the review file and written arguments.
The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments. The
procedures for development of the review file and submission of written
argument are:
(a) Appellant's documents and brief. Within 30 days after receiving
the acknowledgment of the request for review, the appellant shall submit
to the reviewing official the following (with a copy to the respondent):
(1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages,
explaining why respondent's decision to suspend or propose revocation of
appellant's certification or to take adverse action regarding withdrawal
of approval of the accreditation body is incorrect (appellant's brief).
(b) Respondent's documents and brief. Within 30 days after receiving
a copy of the acknowledgment of the request for review, the respondent
shall submit to the reviewing official the following (with a copy to the
appellant):
(1) A review file containing documents supporting respondent's
decision to suspend or revoke appellant's certification, or approval as
an accreditation body, tabbed and organized chronologically, and
accompanied by an index identifying each document. Only essential
documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in
length, explaining the basis for suspension, proposed revocation, or
adverse action (respondent's brief).
(c) Reply briefs. Within 10 days after receiving the opposing
party's submission, or 20 days after receiving acknowledgment of the
request for review, whichever is later, each party may submit a short
reply not to exceed 10 double-spaced pages.
(d) Cooperative efforts. Whenever feasible, the parties should
attempt to develop a joint review file.
(e) Excessive documentation. The reviewing official may take any
appropriate steps to reduce excessive documentation, including the
return of or
[[Page 105]]
refusal to consider documentation found to be irrelevant, redundant, or
unnecessary.
(f) Discovery. The use of interrogatories, depositions, and other
forms of discovery shall not be allowed.
Sec. 8.27 Opportunity for oral presentation.
(a) Electing oral presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the time it
submits its written request for review to the reviewing official. The
reviewing official will grant the request if the official determines
that the decisionmaking process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide for
an oral presentation at the official's own initiative or at the request
of the respondent.
(b) Presiding official. The reviewing official or designee will be
the presiding official responsible for conducting the oral presentation.
(c) Preliminary conference. The presiding official may hold a
prehearing conference (usually a telephone conference call) to consider
any of the following: Simplifying and clarifying issues; stipulations
and admissions; limitations on evidence and witnesses that will be
presented at the hearing; time allotted for each witness and the hearing
altogether; scheduling the hearing; and any other matter that will
assist in the review process. Normally, this conference will be
conducted informally and off the record; however, the presiding official
may, at the presiding official's discretion, produce a written document
summarizing the conference or transcribe the conference, either of which
will be made a part of the record.
(d) Time and place of oral presentation. The presiding official will
attempt to schedule the oral presentation within 45 days of the date
appellant's request for review is received or within 15 days of
submission of the last reply brief, whichever is later. The oral
presentation will be held at a time and place determined by the
presiding official following consultation with the parties.
(e) Conduct of the oral presentation--(1) General. The presiding
official is responsible for conducting the oral presentation. The
presiding official may be assisted by one or more HHS officers or
employees or consultants in conducting the oral presentation and
reviewing the evidence. While the oral presentation will be kept as
informal as possible, the presiding official may take all necessary
steps to ensure an orderly proceeding.
(2) Burden of proof/standard of proof. In all cases, the respondent
bears the burden of proving by a preponderance of the evidence that its
decision to suspend, propose revocation, or take adverse action is
appropriate. The appellant, however, has a responsibility to respond to
the respondent's allegations with evidence and argument to show that the
respondent is incorrect.
(3) Admission of evidence. The rules of evidence do not apply and
the presiding official will generally admit all testimonial evidence
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each
party may make an opening and closing statement, may present witnesses
as agreed upon in the pre-hearing conference or otherwise, and may
question the opposing party's witnesses. Since the parties have ample
opportunity to prepare the review file, a party may introduce additional
documentation during the oral presentation only with the permission of
the presiding official. The presiding official may question witnesses
directly and take such other steps necessary to ensure an effective and
efficient consideration of the evidence, including setting time
limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including,
for example, motions to exclude or strike redundant or immaterial
evidence, motions to dismiss the case for insufficient evidence, or
motions for summary judgment. Except for those made during the hearing,
all motions and opposition to motions, including argument, must be in
writing and be no more than 10 double-spaced pages in length. The
presiding official will set a reasonable time for the party opposing the
motion to reply.
[[Page 106]]
(5) Transcripts. The presiding official shall have the oral
presentation transcribed and the transcript shall be made a part of the
record. Either party may request a copy of the transcript and the
requesting party shall be responsible for paying for its copy of the
transcript.
(f) Obstruction of justice or making of false statements.
Obstruction of justice or the making of false statements by a witness or
any other person may be the basis for a criminal prosecution under 18
U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the presiding official's discretion,
the presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may
submit comments on any major prejudicial errors in the transcript.
Sec. 8.28 Expedited procedures for review of immediate suspension.
(a) Applicability. When the Secretary notifies a treatment program
in writing that its certification has been immediately suspended, the
appellant may request an expedited review of the suspension and any
proposed revocation. The appellant must submit this request in writing
to the reviewing official within 10 days of the date the OTP received
notice of the suspension. The request for review must include a copy of
the suspension and any proposed revocation, a brief statement of why the
decision to suspend and propose revocation is incorrect, and the
appellant's request for an oral presentation, if desired. A copy of the
request for review must also be sent to the respondent.
(b) Reviewing official's response. As soon as practicable after the
request for review is received, the reviewing official will send an
acknowledgment with a copy to the respondent.
(c) Review file and briefs. Within 10 days of the date the request
for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
following:
(1) A review file containing essential documents relevant to the
review, tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages,
explaining the party's position concerning the suspension and any
proposed revocation. No reply brief is permitted.
(d) Oral presentation. If an oral presentation is requested by the
appellant or otherwise granted by the reviewing official in accordance
with Sec. 8.27(a), the presiding official will attempt to schedule the
oral presentation within 20 to 30 days of the date of appellant's
request for review at a time and place determined by the presiding
official following consultation with the parties. The presiding official
may hold a pre-hearing conference in accordance with Sec. 8.27(c) and
will conduct the oral presentation in accordance with the procedures of
Sec. Sec. 8.27(e), (f), and (g).
(e) Written decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation and
will attempt to issue the decision within 7 to 10 days of the date of
the oral presentation or within 3 days of the date on which the
transcript is received or the date of the last submission by either
party, whichever is later. All other provisions set forth in Sec. 8.33
apply.
(f) Transmission of written communications. Because of the
importance of timeliness for these expedited procedures, all written
communications between the parties and between either party and the
reviewing official shall be sent by facsimile transmission, personal
service, or commercial overnight delivery service.
Sec. 8.29 Ex parte communications.
Except for routine administrative and procedural matters, a party
shall not communicate with the reviewing or presiding official without
notice to the other party.
Sec. 8.30 Transmission of written communications by reviewing official
and calculation of deadlines.
(a) Timely review. Because of the importance of a timely review, the
reviewing official should normally transmit written communications to
either party by facsimile transmission, personal service, or commercial
overnight delivery service, or certified mail, return receipt requested,
in which case
[[Page 107]]
the date of transmission or day following mailing will be considered the
date of receipt. In the case of communications sent by regular mail, the
date of receipt will be considered 3 days after the date of mailing.
(b) Due date. In counting days, include Saturdays, Sundays, and
holidays. However, if a due date falls on a Saturday, Sunday, or Federal
holiday, then the due date is the next Federal working day.
Sec. 8.31 Authority and responsibilities of the reviewing official.
In addition to any other authority specified in this subpart C, the
reviewing official and the presiding official, with respect to those
authorities involving the oral presentation, shall have the authority to
issue orders; examine witnesses; take all steps necessary for the
conduct of an orderly hearing; rule on requests and motions; grant
extensions of time for good reasons; dismiss for failure to meet
deadlines or other requirements; order the parties to submit relevant
information or witnesses; remand a case for further action by the
respondent; waive or modify these procedures in a specific case, usually
with notice to the parties; reconsider a decision of the reviewing
official where a party promptly alleges a clear error of fact or law;
and to take any other action necessary to resolve disputes in accordance
with the objectives of the procedures in this subpart.
Sec. 8.32 Administrative record.
The administrative record of review consists of the review file;
other submissions by the parties; transcripts or other records of any
meetings, conference calls, or oral presentation; evidence submitted at
the oral presentation; and orders and other documents issued by the
reviewing and presiding officials.
Sec. 8.33 Written decision.
(a) Issuance of decision. The reviewing official shall issue a
written decision upholding or denying the suspension, proposed
revocation, or adverse action. The decision will set forth the reasons
for the decision and describe the basis for that decision in the record.
Furthermore, the reviewing official may remand the matter to the
respondent for such further action as the reviewing official deems
appropriate.
(b) Date of decision. The reviewing official will attempt to issue
the decision within 15 days of the date of the oral presentation, the
date on which the transcript is received, or the date of the last
submission by either party, whichever is later. If there is no oral
presentation, the decision will normally be issued within 15 days of the
date of receipt of the last reply brief. Once issued, the reviewing
official will immediately communicate the decision to each party.
(c) Public notice and communications to the Drug Enforcement
Administration (DEA). (1) If the suspension and proposed revocation of
OTP certification are upheld, the revocation of certification will
become effective immediately and the public will be notified by
publication of a notice in the Federal Register. SAMHSA will notify DEA
within 5 days that the OTP's registration should be revoked.
(2) If the suspension and proposed revocation of OTP certification
are denied, the revocation will not take effect and the suspension will
be lifted immediately. Public notice will be given by publication in the
Federal Register. SAMHSA will notify DEA within 5 days that the OTP's
registration should be restored, if applicable.
Sec. 8.34 Court review of final administrative action; exhaustion
of administrative remedies.
Before any legal action is filed in court challenging the
suspension, proposed revocation, or adverse action, respondent shall
exhaust administrative remedies provided under this subpart, unless
otherwise provided by Federal law. The reviewing official's decision,
under Sec. 8.28(e) or Sec. 8.33(a), constitutes final agency action as
of the date of the decision.
PART 9_STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY
SUPPORTED SANCTUARY SYSTEM--Table of Contents
Sec.
9.1 Applicability and purpose.
[[Page 108]]
9.2 Definitions.
9.3 Sanctuary policies and responsibilities.
9.4 Physical facility policies and design.
9.5 Chimpanzee ownership, fees, and studies.
9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.
9.7 Reproduction.
9.8 Animal records.
9.9 Facility staffing.
9.10 Occupational Health and Safety Program (OHSP) and biosafety
requirements.
9.11 Animal transport.
9.12 Compliance with the Standards of Care, USDA and PHS policies and
regulations.
9.13 Other federal laws, regulations, and statutes that apply to this
part.
Authority: 42 U.S.C. 216, 287a-3a.
Source: 73 FR 60423, Oct. 10, 2008, unless otherwise noted.
Sec. 9.1 Applicability and purpose.
(a) General. The standards of care set forth in this part apply to
the chimpanzee sanctuaries that are contracted (or subcontracted) to the
Federal Government to operate the federally supported chimpanzee
sanctuary system authorized by section 481C of the Public Health Service
(PHS) Act, as amended (42 U.S.C. 287a-3a).
(b) What is the purpose of the federally supported chimpanzee
sanctuary system and the authority for establishing these standards of
care regulation? The Chimpanzee Health Improvement, Maintenance, and
Protection Act (Pub. L. 106-551, referred to as the ``CHIMP Act'' or
``Chimpanzee Retirement Act'') was enacted by Congress to provide for
the establishment and operation of a sanctuary system to provide
lifetime care for chimpanzees that have been used, or were bred or
purchased for use, in research conducted or supported by the agencies of
the Federal Government, and that are determined to be no longer needed
for such research. The CHIMP Act also mandates that standards of care
for chimpanzees in the sanctuary shall be developed to ensure the well-
being of chimpanzees and the health and safety of the chimpanzees.
(c) To what chimpanzee sanctuaries do the standards of care in this
part apply? The standards of care set forth in this part apply to only
those sanctuaries that are contracted or subcontracted to the Federal
Government to operate the federally supported chimpanzee sanctuary
system.
Sec. 9.2 Definitions.
As used in this part:
Adequate veterinary care means a program directed by a veterinarian
qualified through training and/or experience to provide professional
medical care to the chimpanzees within the Sanctuary and with the
appropriate authority to provide this care. The program also provides
guidance to all caregivers on all matters relating to the health and
well-being of the chimpanzees.
American Zoo and Aquarium Association (AZA) means the professional
society composed of individuals with various backgrounds and interests
that are devoted to advancing the knowledge and understanding of zoo
animals and the management of zoos in the United States.
American Zoo and Aquarium Association (AZA) Accreditation Standards
are those standards developed by the AZA that are used to review,
evaluate, and accredit zoos or zoological gardens. These standards cover
a variety of areas including facilities, policies and procedures,
training, staff qualifications, medical and animal care, husbandry and
well-being procedures, and conservation, along with other specific
areas.
Animal Care and Use Committee means the Institutional Animal Care
and Use Committee established under section 13(b) of the Animal Welfare
Act of 1985 and the Health Research Extension Act of 1985. For the
purpose of these Standards of Care, it shall consist of at least five
(5) members including the Chairperson, a Doctor of Veterinary Medicine
(D.V.M. or V.M.D.) knowledgeable in nonhuman primate care and diseases
and with delegated program responsibility, a member not affiliated with
the Sanctuary, a scientist, and a member of the animal protection
community. The requirement that a member of the ACUC must be from an
animal protection organization is unique to this part and is not
required under the Animal Welfare Regulations or the Public Health
Service Policy on the Humane Care and Use of Laboratory Animals. This
Committee must be established if research as defined by the Animal
Welfare Act Regulations and the Public
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Health Service Policy (research, teaching, testing, exhibition) is to be
conducted at the sanctuary.
Animal protection organization means a nonprofit organization whose
primary mission is protection of animals through positive advocacy and
action.
Animal Resource Manager (or Animal Resource Supervisor) means the
individual employee responsible for managing the nonprofessional staff
providing care for the chimpanzees at the sanctuary. This individual may
perform other duties as assigned by the Sanctuary Contractor.
Animal Welfare Act/Regulations means the Act of August 24, 1966
(Pub. L. 89-544, commonly known as the Laboratory Animal Welfare Act),
as amended by the Act of December 24, 1970 (Pub. L. 91-579, the Animal
Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279, the
Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L.
99-198, the Food Security Act of 1985), and as may be subsequently
amended, and the United States Department of Agriculture (USDA)
regulations implementing the Animal Welfare Act in title 9, chapter 1,
subchapter A of the CFR.
Animal Welfare Assurance means the documentation from an institution
assuring compliance with the PHS Policy on Humane Care and Use of
Laboratory Animals. This policy is administered by the Office of
Laboratory Animal Welfare (OLAW), National Institutes of Health.
Association for Assessment and Accreditation of Laboratory Animal
Care, International (AAALAC) means the nonprofit organization that is
recognized in the United States and abroad as being the body responsible
for the accreditation of laboratory animal programs.
Behaviorist means a person hired by the sanctuary to administer or
oversee the enrichment and behavioral program for the chimpanzees at the
sanctuary. This individual must be qualified through training or
experience.
Biosafety Officer means the individual responsible for establishing
and monitoring workplace safety procedures designed to minimize or
prevent injury or loss due to biohazards in accordance with policies
established by the sanctuary administration.
Board of Directors (BOD) means the individuals selected by the
Contractor to govern the nonprofit institution responsible for operating
the federally supported chimpanzee Sanctuary system. The board members
must meet the qualifications and criteria stated in the CHIMP Act.
Chair of the Board of Directors means the individual chosen by the
BOD or other legally empowered entity to carry out such action, who is
responsible for chairing meetings and acting on behalf of the board.
This individual reports directly to the Board.
Chief Executive Officer (CEO) means the principal person responsible
for overall accomplishment of the mission of the chimpanzee sanctuary.
CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and
Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as
the ``CHIMP Act'' or ``Chimpanzee Retirement Act,'' and any future
amendments.
Chimpanzee means a member of Pan troglodytes. It excludes the pygmy
chimpanzee (Pan paniscus or bonobo).
Chimpanzee caregivers (caregivers) mean all sanctuary technical and
husbandry staff providing long-term care and services for the
chimpanzees.
Contractor/Primary Contractor/Sanctuary Contractor means the
nonprofit entity awarded a contract by the Federal Government to
establish and operate the chimpanzee sanctuary system.
Euthanasia means the humane death of a chimpanzee accomplished by a
method that produces rapid unconsciousness and subsequent death without
evidence of pain or distress. The method must be consistent with the
recommendations of the American Veterinary Medical Association Panel on
Euthanasia.
Exhibition means exhibiting chimpanzees to the public for
compensation. This definition excludes limited viewing for educational
purposes that are not disruptive to the chimpanzees.
Facility director means the individual responsible for directing the
overall activities at the Sanctuary site.
Facility Veterinarian means a person who has graduated from a
veterinary school accredited by the American Veterinary Medical
Association (AVMA)
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Council on Education, or who has a certificate issued by the AVMA's
Education Commission for Foreign Veterinary Graduates; has training and/
or experience in the care and management of nonhuman primates; and has
direct or delegated authority for activities involving chimpanzees at
the federally funded chimpanzee sanctuary.
Federal Acquisition Regulations (FAR) means the codified rules
applicable to contracts, specifically those sections of the FAR (48 CFR
chapter 1, part 52) that are applicable to contracts between the Federal
Government and a contractor (in this case a private, nonprofit entity
under contract to operate the chimpanzee sanctuary system).
Federal agency means an executive agency as such term is defined in
section 105 of title 5, United States Code, and refers to the agency
from which the research facility receives a Federal award for projects
involving animals.
Federally owned chimpanzees mean chimpanzees that have been
purchased by, bred by, or donated to a federal agency for use in
biomedical/behavioral research. Chimpanzees whose ownership was
subsequently transferred from Federal ownership via written transfer
agreements are no longer federally owned.
Guide means The Guide for the Care and Use of Laboratory Animals,
published by the National Academy of Sciences, Institute for Laboratory
Animal Research of the National Research Council, 1996, International
Standard Book Number 0-309-05377-3.
Housing facility means any land, premises, shed, barn, building,
trailer, or other structure or area housing intended to house
chimpanzees.
Indoor housing facility refers to any structure or enclosure (for
example, cages, pens, rooms) for maintaining animals in a controlled
environment that provides for normal physiological and behavioral needs.
Interstate air transport live animals (IATA) regulations means those
regulations and standards covering the air transportation of nonhuman
primates developed and implemented by the International Air
Transportation Association.
Invasive research (studies) utilizes those procedures that cause
more than momentary pain, distress, fear, discomfort, injury, or other
negative modalities to a chimpanzee. Any procedure that enters or
exposes a body cavity is considered to be invasive. Sanctuary
chimpanzees may not be used in invasive research. This definition
excludes any invasive procedure that is a part of veterinary, medical,
or surgical care that is performed by or under the direction of the
Sanctuary Veterinarian using acceptable veterinary practices. Some
examples of invasive studies are:
(1) Experimental exposure to a substance that may be detrimental to
a chimpanzee's health (e.g., infectious disease, radiation). This does
not include accidental exposures to infectious diseases transmitted from
cage mates or from radiation or other exposures at the time of regularly
scheduled or necessary veterinary examinations and treatments;
(2) Any invasion of a body cavity;
(3) Surgery and surgical implantation of devices that are not a part
of a veterinary medical treatment or colony management purposes.
(4) Behavioral studies that cause distress or discomfort, such as
induction of a fear response;
(5) Testing of any drug;
(6) Purposeful manipulation of social groups or the removal from
their social group or addition of individuals in order to conduct
behavioral research (for example, on aggression). Creation and
refinement of social groups will be necessary when the animals arrive at
the Sanctuary and this should take place only when necessary in regards
to colony management and should not be driven by independently initiated
research studies;
(7) Restraint unless it is in conjunction with the annual exam or
clinical care; and
(8) Darting or anesthesia induction other than at annual exam or in
the case of an emergency in which the chimpanzee's well-being is at
stake.
National Primate Research Center (NPRC) means those centers
supported by the National Center for Research Resources, National
Institutes of Health, Department of Health and Human Services, as
national resources for providing high-quality nonhuman
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primate research resources and facilities. As of June 2007, there were
eight such centers.
National Research Council means the component of the National
Academy of Sciences that advises the Federal Government on matters
related to science, research, and research resources.
Nonfederally owned chimpanzees mean chimpanzees that have not been
purchased by, bred by, or donated to the Federal Government for use in
federally supported research projects. In accordance with the CHIMP Act,
chimpanzees owned on the date of passage of the CHIMP Act by a National
Primate Research Center may enter the sanctuary system without requiring
the NPRC to pay a fee. Offspring born in the sanctuary is owned by the
Sanctuary Contractor.
Noninvasive research (studies) means the use of procedures that
depend upon close observation of chimpanzee behavior or on medical
information collected during the course of normal veterinary care. These
procedures do not require removal of the chimpanzees from their social
group or environment, or require a separate anesthetic or sedation event
to collect data or record observations. Some examples of noninvasive
studies are:
(1) Visual observation;
(2) Behavioral studies designed to improve the establishment and
maintenance of social groups. These activities may cause stress as a
result of novel interactions between chimpanzees and caregivers, but
they are not considered invasive as long as they are intended to
maximize the well-being of the chimpanzees;
(3) Medical examinations as deemed necessary to oversee the health
of the chimpanzees, in the least invasive manner possible. Collection of
samples routinely obtained during a physical examination for processing
during this time is also considered noninvasive since a separate event
is not required;
(4) Administration and evaluation of environmental enrichment used
to promote the psychological well-being of the chimpanzees; and
(5) Actions taken to provide essential medical treatment to an
individual chimpanzee exhibiting symptoms of illness. This applies only
to serious illness that cannot be treated while the chimpanzee remains
within the colony.
Outdoor housing facility (area) means corrals, Primadomes (a
prefabricated outdoor housing unit), fenced open areas, or similar
structures or areas for maintaining chimpanzees with access to adequate
protection from the extremes of environmental elements and harsh weather
conditions.
Outdoor ranging area means an area that allows chimpanzees greater
ranging space than corrals or other outdoor housing area and includes a
variety of vegetation, shrubbery, grasses and trees, thereby providing
for a fairly unrestricted natural setting for the chimpanzees to engage
in species-appropriate activities. The area is secured by an outer
perimeter barrier.
Project Officer means the individual designated by the Federal
Government to represent the contracting officer and interests of the
federal agency, within defined areas, in monitoring and overseeing the
chimpanzee sanctuary system contract.
Sanctuary Chimpanzee Care Committee (SCCC) or similar designated
committee means the group of individuals designated by the CEO of the
sanctuary that reviews and monitors adherence to the policies,
procedures, and regulations at the sanctuary.
Sanctuary Contractor means the nonprofit, private entities selected
by NCRR/NIH to develop and operate the chimpanzee sanctuary system. This
contractor is also known as the ``primary contractor'' for the sanctuary
system.
Sanctuary Director means the individual who provides day-to-day
direction and oversight to the employees responsible for performing the
daily tasks at the facility.
Sanctuary or federally supported chimpanzee sanctuary system means
the sanctuary or sanctuary system established by the Federal Government
through contracting with a private, nonprofit entity, for the purpose of
carrying out the provisions of the CHIMP Act of 2000. The system
includes a primary Contractor and may include additional subcontractors
as required. This sanctuary system is supported primarily from funds
allocated by NCRR/
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NIH/HHS with some matching funds from the nonprofit contractor.
Secretary means the Secretary of Health and Human Services or his/
her designee.
Subcontractor means a private, nonprofit entity selected by the
primary contractor to provide additional sanctuary services.
Surplus chimpanzees means chimpanzees that are no longer needed in
research and that were used, or were bred or purchased for use, in
research conducted or supported by the Federal Government.
USDA licensed intermediate handler/carrier means any person,
including a department, agency, or instrumentality of the United States
or of any State or local government, who is engaged in any business in
which it receives custody of animals in connection with their
transportation in commerce and who is licensed by the USDA.
Zoonotic disease(s) means diseases that are transmissible from
chimpanzees to humans.
Sec. 9.3 Sanctuary policies and responsibilities.
(a) What are the policies and responsibilities governing the
sanctuary system? It will be the policies and responsibilities of the
sanctuary system to:
(1) Appoint a Board of Directors (BOD) responsible for the overall
governance and direction of the Sanctuary. The BOD shall designate the
Chief Executive Officer (CEO), who is responsible for the management and
oversight of the daily operations of the sanctuary and the performance
of other delegated tasks. Subcontractors, if applicable, shall be
governed by the policies that are developed by the Board of Directors of
the primary contractor.
(2) Direct the BOD to:
(i) Ensure that chimpanzees accepted into the sanctuary are not
discharged;
(ii) Develop guidelines for accepting chimpanzees not owned by the
Federal Government into the sanctuary if the conditions are met as
outlined in 42 U.S.C. 287;
(iii) Ensure that the Board of Directors of the primary contractor
consists of no more than thirteen (13) individuals, and that the
conditions governing the terms of the Board members are in compliance
with the CHIMP Act;
(iv) Include individuals with the following expertise and experience
as set forth in the CHIMP Act;
(A) At least one veterinarian who is qualified in veterinary care of
nonhuman primates. These qualifications may be met through postdoctoral
training, experience, or both;
(B) Individual(s) with expertise and experience in zoological
science and with knowledge in behavioral primatology;
(C) Individual(s) with experience in the animal protection field;
(D) Individual(s) with experience and expertise in the field of
business and management of nonprofit organizations;
(E) Individual(s) knowledgeable and experienced in accrediting
programs of animal care;
(F) Individual(s) with experience and expertise in containing
biohazards;
(v) Ensure that a member of the Board of Directors serves as the
Chair of the Board of Directors, who may be elected or appointed by the
Board from among the individuals identified in paragraphs (a) (1) (iv)
(A) through (F) of this section;
(vi) Ensure that no member of the board shall have been fined for,
or signed a consent decree for, any violation of the Animal Welfare Act;
(vii) Create a safe and species-appropriate physical and social
environment for the lifetime care of chimpanzees;
(viii) Comply with all applicable provisions of the animal welfare
regulations and other federal, state and local laws, regulations, and
policies;
(ix) Achieve accreditations from appropriate accrediting bodies
within a reasonable time frame mutually agreed upon by the Contractor
and NCRR;
(x) Prohibit any invasive research on the resident chimpanzees, but
permit noninvasive studies (Definitions for the terms invasive and non-
invasive are set forth in Sec. 9.2 of this part.);
(xi) Prohibit exhibition of chimpanzees in the sanctuary (This
policy does not prohibit educational activities that may involve limited
viewing of chimpanzees in their environment and
[[Page 113]]
that are designed to promote an understanding of chimpanzee behavior,
well-being, or importance to the ecological system that does not
adversely affect the chimpanzees' routine.);
(xii) Staff the organization with people with appropriate
experience; and
(xiii) Authorize the establishment of a Sanctuary Chimpanzee Care
Committee (SCCC) that is appointed by and reports to the CEO or
President of the company or corporationThe SCCC is responsible for
overseeing the chimpanzee care program and operations to ensure the
health and well-being of the chimpanzees and the occupational safety of
the staff are being addressed. The Committee must consist of no fewer
than five people who must include:
(A) A chair (person) knowledgeable of the needs of chimpanzees;
(B) A veterinarian with chimpanzee care experience;
(C) A behaviorist with experience in chimpanzee behavior;
(D) A member of the chimpanzee care staff; and
(E) Member or members from the community, including at least one
with affiliation or employment with an animal protection organization as
defined in Sec. 9.2 of this part.
(F) The SCCC will:
(1) Oversee and evaluate the chimpanzee care and socialization
program;
(2) Review and approve proposed education programs. No program
should be approved that might interfere with the chimpanzees' well-being
or routine activities;
(3) Conduct a formal review of the program on a semiannual basis and
submit reports to the Sanctuary Director. The reports must be available
for review by the USDA and NIH representatives during site visits;
(4) Establish a mechanism for receipt and review of concerns
involving the care of chimpanzees and resolving such concerns;
(5) Review all noninvasive study proposals. The SCCC membership may
require additional qualified individuals to perform the functions of an
Animal Care and Use Committee (ACUC) if and when the need arises. The
contractor may establish a separate ACUC. The ACUC must be established
in accordance with the applicable provisions of the Animal Welfare Act
regulations, the Public Health Service Policy on Humane Care and Use of
Laboratory Animals, and these standards of care;
(6) Review all euthanasia events. Euthanasia events performed for
medical or humane reasons must be based upon sound professional
veterinary judgment that conforms to current veterinary medical
practices and must be in the best interest of the chimpanzee. Euthanasia
performed for emergency reasons without advance review by the SCCC shall
be reviewed by the SCCC as soon as possible after the event to ensure
compliance with established policy;
(7) Establish procedures to prevent any reproduction in the colony
through appropriate permanent birth control, preferably by vasectomy of
all sexually mature male chimpanzees in the sanctuary; and
(8) Develop procedures for maintaining chimpanzees that are
seropositive for or harboring infectious agents or previously have been
exposed to infectious agents (whether experimentally induced or
naturally occurring) that will allow them to be accepted by the
sanctuary and properly housed. The procedures must be submitted to NCRR/
NIH for approval.
(b) Who is responsible for developing or revising sanctuary
policies? (1) The Sanctuary Contractor is responsible for developing,
revising, and implementing policies affecting the sanctuary.
(2) The federal agency (NCRR/NIH) designated by the Secretary must
concur with any changes that substantially change existing policies. The
Secretary, or designee, will determine if a policy change will have a
substantial impact upon current policy after consultation with the
Sanctuary Contractor.
Sec. 9.4 Physical facility policies and design.
(a) What standards apply to the facility design and physical plant?
The chimpanzee sanctuary facility must be designed to provide sufficient
space and variety of natural or artificial objects to accommodate
natural activities of chimpanzees while restricting their movement and
range to the defined area. Daily observation of chimpanzees
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within the enclosures is required and shall be accomplished with minimal
disturbance to the chimpanzees. The facility design and physical plant
should be in accordance with the recommendation of The Guide for the
Care and Use of Laboratory Animals (Guide), where applicable. The Guide
is published by the National Research Council, 1996, International
Standard Book Number 0-309-05377-3. The Guide is incorporated by
reference in this section. The Director of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain a copy of the publication from the National
Academy Press, 2101 Constitution Avenue, NW., Lockbox 285, Washington,
DC 20055; or you may order it electronically via the Internet at http://
www.nap.edu; or view it online at http://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at NIH, NCRR, 1 Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20817-4874, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(1) The facility design and physical plant consist of the following
components: Indoor design features; outdoor design features;
construction and construction materials; physical barriers; shelter;
service support space, including storage areas for food, supplies, and
equipment; personnel and administrative support space; quarantine and
isolation facilities; treatment area; heating, ventilation, and air
conditioning (HVAC); food preparation area; and animal waste treatment.
(2) A housing system shall include indoor and outdoor enclosures
that must be kept in good repair to prevent escape and injury to the
chimpanzees, promote physical comfort, facilitate sanitation and
servicing, and address the psychological well-being and social needs of
the chimpanzees. Chimpanzees must be able to retreat from areas where
they feel threatened or agitated by close human encounters or encounters
with other chimpanzees.
(3) Indoor areas shall have special areas for social introductions
and medical treatment. Quarantine and isolation facilities are required
for the sanctuary. These facilities must be designed to prevent the
spread of undesirable agents from quarantine and isolation rooms to
other parts of the facility.
(4) Outdoor areas must provide sufficient ranging space and either
natural or artificial structures that chimpanzees can use for shelter or
nesting areas to sleep, rest, or seek refuge from rain, direct sun,
wind, and extreme temperatures.
(5) Animal waste from the Sanctuary must be properly treated to
remove known hazardous agents before discharging it into the environment
in accordance with currently acceptable and effective waste treatment
procedures, including current industry standards and Federal laws,
regulations or guidelines, as applicable.
(6) An area for treatment of and performing veterinary clinical
procedures on chimpanzees must be provided at each Sanctuary site. This
area must be constructed and provisioned to perform emergency
procedures, including minor surgery and emergency surgical procedures,
complete physical examinations, and facilities for extended care of
medical conditions as needed.
(b) What security measures are required for the sanctuary? The
sanctuary must provide adequate security against unauthorized entry,
sabotage, malicious damage, and theft of chimpanzees and property and
must minimize any chance of escape by a chimpanzee. The security staff
must have training and/or experience in methods and equipment designed
to detect possible security breaches and the ability to respond to
security events in a timely and effective manner. Perimeter containment
shall be used to protect the compound housing the chimpanzees consistent
with the recommendations of the Guide (incorporated by reference, see
paragraph (a) of this section).
(c) Is the sanctuary required to develop disaster and escaped animal
contingency plans? The sanctuary facility must prepare disaster and
escaped animal contingency plans outlining simple and easy to follow
plans for dealing with
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natural and man-made disasters and steps to be taken in case a
chimpanzee escapes from the compound. The Sanctuary also must provide
adequate security against unauthorized entry, sabotage, malicious
damage, and theft of chimpanzees and property and must minimize any
chance of escape by a chimpanzee. Primary barriers must be constructed
to prevent escape of chimpanzees and secondary or perimeter barriers
must prevent entry of unauthorized persons into the facility, consistent
with the recommendations of the Guide (incorporated by reference, see
paragraph (a) of this section).
Sec. 9.5 Chimpanzee ownership, fees, and studies.
(a) Who owns the chimpanzees in the federally supported sanctuary?
The Federal Government retains ownership of chimpanzees owned by the
Federal Government at the time they enter the sanctuary system. Non-
federally owned or supported chimpanzees will be owned by the sanctuary.
The chimpanzees shall continue to be maintained in the sanctuary
throughout their lifetime and shall not be discharged from the sanctuary
except as specifically indicated in the CHIMP Act.
(b) Is there a charge for placing chimpanzees in the sanctuary? No
fees shall be charged by the Sanctuary Contractor for federally owned or
supported chimpanzees entering the sanctuary. Chimpanzees that were
owned by a NPRC when the CHIMP Act became effective are also admitted
without payment of fees. Fees for maintenance of the chimpanzees alluded
to above are provided for in the contract between the Federal Government
and the Sanctuary Contractor.
(c) May the sanctuary agree to accept chimpanzees that are not owned
by the Federal Government? The sanctuary may accept chimpanzees that are
not owned by the Federal Government subject to the following conditions:
(1) Ownership of the chimpanzee must be transferred to the
sanctuary;
(2) Fees for these chimpanzees may be levied based on a range of
considerations that include most importantly, the well-being of the
chimpanzee and, secondarily, factors that include (but are not limited
to) the resources available to support the chimpanzee; the health, age,
and social history of the chimpanzee; and other relevant factors
affecting the cost of caring for the chimpanzee. While chimpanzees not
owned or supported by the Federal Government may be admitted to the
sanctuary, federal funds may not be used for their support unless
authorized by the Secretary or an authorized designee;
(3) Available space exists in the sanctuary; and
(4) An agreement exists between the sanctuary system and the NCRR/
NIH documenting that the chimpanzee may be brought into the sanctuary.
(d) What additional conditions apply when nongovernmental owned
chimpanzees transfer to the chimpanzee sanctuary? The following
additional conditions apply when nongovernmental owned chimpanzees
transfer to the chimpanzee sanctuary:
(1) Chimpanzees transferred to the sanctuary sites must be
permanently incapable of reproduction, for example, by vasectomy, tubal
ligation, or another reliable procedure;
(2) Complete histories must accompany each chimpanzee. Any
chimpanzee missing documentation for any period of research or other use
may not be transferred to the Sanctuary without the concurrent
authorization of the Sanctuary Contractor's Board of Directors and the
NCRR; the records may be created and retained in electronic form; and
(3) Appropriate screening of each chimpanzee must be performed to
assess the likelihood of the chimpanzee being a health or safety threat
to the care staff and/or other chimpanzees.
(e) What are the criteria for acceptance and the fees for admission
into the sanctuary for nongovernmental owned chimpanzees? The chimpanzee
Sanctuary Contractor, in conjunction with NCRR, must establish criteria
and a fee system for acceptance of nongovernmental owned chimpanzees.
Funds collected for this purpose must be accounted for and used to help
defray the expenses incurred in operating the sanctuary.
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(f) Under what circumstances might a chimpanzee from the sanctuary
be returned to research at a United States research facility? In
December 2007, the CHIMP Act was amended by the ``Chimp Haven is Home
Act,'' which terminated the authority for the removal of chimpanzees
from the sanctuary system for research purposes.
Sec. 9.6 Animal care, well-being, husbandry, veterinary care,
and euthanasia.
(a) What are the requirements for promoting the well-being of
sanctuary chimpanzees? The goal of chimpanzee housing and management in
the sanctuary is to promote the chimpanzees' well-being.
(b) What are the provisions for daily chimpanzee husbandry and care?
Adequate and proper care for chimpanzees in the sanctuary must be
provided with respect to physical environment, housing and husbandry,
behavioral management, and population management and control. Specific
requirements include the following:
(1) Chimpanzees must have access to food, water, and bedding at all
times, unless medical or behavioral conditions dictate otherwise.
Husbandry procedures shall represent current policies and practices and
conform to standards set by a nationally recognized accrediting
association in accordance with the Guide (incorporated by reference, see
paragraph (a) of Sec. 9.4).
(2) Indoor primary enclosures must be cleaned as often as required
to maintain a clean and healthy environment, with a minimum of once
daily. Outdoor enclosures must be monitored daily and cleaned on a
routine basis. Outdoor ranging areas will not require a routine cleaning
schedule but must be monitored for excessive accumulation of waste or
other unhealthy conditions. Housing areas shall provide sufficient space
for chimpanzees to perform species-typical behavior and expression.
Examples of such activities include but are not limited to natural
movements, climbing, swinging, resting, running, group interactions,
sleeping, etc. Feeding and watering implements must be sanitized at
intervals required to maintain them in a sanitary condition, in
accordance with the Guide (incorporated by reference, see paragraph (a)
of Sec. 9.4).
(3) The federally supported chimpanzee sanctuary must employ a
behavioral scientist knowledgeable in primate behavior and socialization
requirements. This individual shall provide primary leadership in
developing, implementing, and monitoring the chimpanzee behavioral
guidelines for the sanctuary. Enrichment techniques used shall be
currently accepted practices. The sanctuary must provide for the
expertise to plan, administer, and evaluate the effectiveness of the
well-being program.
(4) Many chimpanzees can be trained through positive reinforcement
to cooperate with a variety of veterinary and chimpanzee care
procedures. Efforts must be made to develop or maintain this capability
for chimpanzees housed in the sanctuary to the extent possible. Trainers
must use currently acceptable practices that do not include physical
punishment.
(c) What are the requirements for an adequate veterinary care and
animal health program? The sanctuary staff must provide sufficient
resources of personnel, equipment, supplies, and facilities to enable
the provision of adequate veterinary care as set forth in the Guide
(incorporated by reference, see paragraph (b) of Sec. 9.4). For
additional guidance see the American College of Laboratory Animal
Medicine document, ``The Provision of Adequate Veterinary Care,''
available on the Internet at http://www.aclam.org.
(1) If the sanctuary houses chimpanzees with infectious diseases, it
must have a veterinarian knowledgeable in the infectious diseases and
care of chimpanzees. The Facility Veterinarian is responsible for
establishing and implementing a health monitoring system specifically
designed to meet the health requirements of chimpanzees in the
sanctuary. Routine observation and the prevention of disease, metabolic
conditions, abnormal behavior and injury must be a priority focus of the
Facility Veterinarian and staff.
(2) Newly received chimpanzees must be quarantined for a period for
physiological, psychological, and nutritional stabilization before their
introduction
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to the rest of the group. The stabilization period must be lengthened
appropriately if the chimpanzee has a significant medical problem or if
abnormal medical findings are detected during the quarantine period. If
the chimpanzee has not been given a complete physical examination within
six months, an examination must be conducted during the stabilization
period.
(3) The sanctuary must implement appropriate methods for disease
surveillance and diagnosis of diseases, which may include the following:
(4) Tuberculin (TB) tests must be negative for two (2) consecutive
tests before the chimpanzee is released from quarantine. Any chimpanzee
that is suspected of harboring the TB organism, or that is diagnosed
with TB will be isolated and treated until determined by the Facility
Veterinarian to be of no health risk to other chimpanzees or humans. The
Facility Veterinarian may recommend euthanasia in those cases that do
not respond to therapy and in which the chimpanzee consequently
experiences undue pain and suffering that cannot be alleviated. The
procedures noted under Sec. 9.6 (d) must be observed if euthanasia is
necessary.
(5) Fecal samples must be checked for parasites and parasitic ova.
(6) A complete blood count and serum chemical panel must be
obtained.
(7) Additional serum for banking and/or testing shall be obtained as
appropriate by the Facility Veterinarian and is considered beneficial
for chimpanzee health.
(8) If the donating facility did not test for the appropriate
viruses, the sanctuary must perform a viral panel and serology for the
various chronic hepatitis viruses and HIV.
(9) Additional tests or procedures that are deemed beneficial to the
chimpanzees' health may be required by the Facility Veterinarian.
(10) Chimpanzees are susceptible to many of the vaccine preventable
diseases of human childhood. Appropriate vaccines must be considered and
administered if deemed necessary, at the discretion of the Facility
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of
disease prevention, diagnosis, and therapy must comply with those
currently accepted in veterinary medical practice. Arrangements with
diagnostic laboratories must be established before chimpanzees arrive at
the sanctuary.
(11) The sanctuary must minimize the use of physical and chemical
restraint. Chimpanzees in the sanctuary shall be trained to permit
certain procedures with minimal or no restraint. Such procedures may
include injections, dosing or other treatments, and cage-side health
observations. However, chemical sedation sometimes may be appropriate
for certain necessary medical interventions or for the safety of the
chimpanzee and caregivers. If physical restraint measures are necessary,
due consideration must be given to the temporary or permanent effects
upon the chimpanzee and human and animal safety concerns.
(12) Methods used to relieve pain must be documented in the
chimpanzee medical or surgical records. These records will be available
for review by USDA and NIH representatives. The Facility Veterinarian
must ensure that pain management is current and in accordance with
acceptable veterinary medical practices.
(13) Chimpanzees must be cared for by qualified personnel on a daily
basis, including weekends and holidays, to safeguard their well-being.
Emergency veterinary care must also be available during these times.
Notification procedures must be documented in the form of operating
procedures.
(d) Under what circumstances is euthanasia permitted? As stated in
section 481C(d)(2)(I) of the Public Health Service Act, as added by
section 2 of the CHIMP Act, none of the chimpanzees may be subjected to
euthanasia except when it is in the best interest of the chimpanzee
involved as determined by the SCCC and the Facility Veterinarian.
Therefore, euthanasia for medical or humane reasons is permitted.
Euthanasia may be permitted for reasons of health or quality of life of
the individual chimpanzee, including for disease, in connection with
trauma, complications of aging, or for other humane reasons. The
sanctuary must establish a policy on euthanasia that will provide
conditions that must be met
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before euthanasia is permitted and guidance for performing euthanasia.
(1) Methods of euthanasia will be consistent with the most recent
report of the American Veterinary Medical Association Panel on
Euthanasia (2002), unless more reliable data becomes available. When
euthanasia is performed, the veterinarian will determine the appropriate
agent, and it will be administered only by properly trained personnel
under the direction of the Facility Veterinarian. The decision to
perform euthanasia will be made by the veterinarian in consultation with
the Facility Director or Deputy Director.
(2) The SCCC will participate in the decision in nonmedical
emergencies. All euthanasia decisions must be reviewed by the SCCC,
preferably prior to euthanasia. In emergencies, where euthanasia has to
be performed immediately by the Facility Veterinarian, the circumstances
and the decision by the Facility Veterinarian will be presented at the
next scheduled or special meeting of the SCCC. The NCRR Project Officer
must be notified of the euthanasia event within 72 hours by electronic
or telephonic means. Euthanasia of individual chimpanzees may negatively
affect the care staff and appropriate counseling and psychological
support shall be considered.
Sec. 9.7 Reproduction.
Chimpanzee reproduction is prohibited in the sanctuary. Therefore,
all males must be sterilized by vasectomy before acceptance into the
system, or, as a temporary measure, housed apart from females until they
are sterilized. Vasectomies are advisable because they are minimally
invasive and because effectiveness of the vasectomy may be validated
through laboratory testing for semen. Seminal collection techniques must
be carefully evaluated to avoid painful stimuli. Other proven methods of
birth control may be used under special conditions deemed appropriate by
the Facility Veterinarian and SCCC. The Facility Veterinarian must
determine the appropriate test(s) to use to validate sterility. A
veterinarian experienced in performing vasectomies in chimpanzees should
perform the operation. Documentation must accompany each male accepted
to the sanctuary system attesting to the fact that the male has been
vasectomized and laboratory tests confirm that a segment of the Vas
Deferens has been removed, or that the test used is reliable and is
negative for sperm. The sanctuary must have a contingency plan for
handling accidental births that includes the length of time the
offspring is expected to remain with the mother.
Sec. 9.8 Animal records.
(a) What records must be maintained for chimpanzees in the sanctuary
and how are they managed? (1) Contractors and Subcontractors operating
the federal chimpanzee sanctuary system must maintain appropriate
records to allow for accountability and disposition of chimpanzees under
their care as required by the USDA Animal Welfare Regulations (9 CFR
2.35). The records may be created and retained in electronic form.
(2) The animal records currently required by the USDA Animal Welfare
Regulations are also required for these standards. Chimpanzees must be
individually and permanently identifiable.
(3) Retrievable records must be maintained for a minimum of three
years beyond the disposition or death of each chimpanzee in accordance
with the Animal Welfare Regulations section 2.35(f) (9 CFR 2.35(f)).
Original records or a copy must be transferred if the chimpanzee moves
to a different facility. The records must include standard information,
including permanent individual identification, research use(s),
reproductive status (past and present), a summary or copy of the medical
and behavioral history, the sire's identification number (if available),
the dam's identification number, birth date, sex, and date acquired by
the sanctuary. The disposition date must also be noted, if applicable,
including whether the chimpanzee died or was transferred to another site
in the federal sanctuary system. The records may be created and retained
in electronic form.
(4) The contractor and any subcontractor(s) operating the federally
supported chimpanzee sanctuary must provide special, quarterly, and
annual
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progress reports to the designated Federal officials as identified in
the contract. The annual report must also contain a statement that
certifies the sanctuary is in full compliance with these standards of
care regulation.
(b) What are the rules governing the disposition of necropsy
records? The CHIMP Act requires that necropsy records from chimpanzees
previously used in federally funded research projects be made available
on a reasonable basis to investigators engaged in biomedical or
behavioral research. In order to comply with this provision, the
contractor for the sanctuary system must devise a plan that will allow
interested parties to contact the sanctuary and receive necropsy records
when they become available. Records may be provided free of charge but
requesters may be required to pay for packaging and shipping costs. The
records may be created and retained in electronic form.
Sec. 9.9 Facility staffing.
How many personnel are required to staff the chimpanzee sanctuary
and what qualifications and training must the staff possess? (a) The
professional, managerial, and support staff must be sufficient to
support the scope and diversity of the activities and chimpanzee
population of the sanctuary. The level of staffing shall be adequate to
ensure that the chimpanzees receive appropriate health care, are well
cared for, and the administrative and fiscal operations are sound and in
keeping with current practices required by NCRR/NIH;
(b) There must be a sufficient number of appropriately trained
animal care and technical personnel to provide appropriate care to the
chimpanzees at all times, including evenings, weekends, and holidays.
The number of animal care staff to chimpanzee ratio shall be adjusted as
experience is gained during the operation of the sanctuary. Sufficiently
trained staff also must be available to maintain adequate behavioral
enrichment;
(c) The Facility Director must be a person with experience in
chimpanzee care and socialization techniques. In addition, the Director
must have management and administrative experience;
(d) The Biosafety Officer must have experience in developing and
monitoring biohazards and dealing with biosafety issues related to
captive nonhuman primates. Experience in these areas dealing
specifically with chimpanzees is desirable;
(e) The remaining staff, which may include part-time, full-time, or
contractor Facility Veterinarian(s) and Behaviorist(s), must possess the
skills, knowledge, and/or experience required to perform their duties,
as elaborated within the regulation.
Sec. 9.10 Occupational Health and Safety Program (OHSP) and biosafety
requirements.
(a) How are employee Occupational Health and Safety Program risks
and concerns addressed? The sanctuary shall assure that an Occupational
Health and Safety Program (OHSP) is developed and implemented in
accordance with current veterinary medical practices and the guidelines
and standards found in the Guide (incorporated by reference, see
paragraph (a) of section 9.4);
(b) How are biosafety concerns addressed? The sanctuary shall
institute and administer an effective biosafety program that addresses
the biosafety hazards at that particular site. The program shall include
identifying biohazards, outlining practices and procedures to be
followed, providing personal safety equipment or protective clothing and
equipment, and establishing a description of the facility requirements
for working with hazardous agents or materials. Policies and procedures
must be implemented to avoid exposure to environmental and animal
hazards. Biosafety must be included in the training program for all
Sanctuary employees. In establishing a program, the Sanctuary must use
current accepted practices and publications prepared by the CDC, NIH,
and professional societies specializing in biosafety. The input and
guidance of personnel trained or experienced in biosafety are essential.
Complete records of both clinical and experimental agent
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exposure must accompany each chimpanzee sent to the sanctuary. The
donating facility must also provide recent testing (for example,
serology, virus culture, histology) so that the sanctuary staff is fully
aware of the health condition of the arriving chimpanzee. The records
may be created and retained in electronic form.
Sec. 9.11 Animal transport.
The transportation of chimpanzees by surface or air must be in
accordance with the requirements set forth in the Animal Welfare Act and
Regulations and the International Air Transport Association (IATA) Live
Animal Regulations and guidelines, as applicable.
Sec. 9.12 Compliance with the Standards of Care, and USDA and PHS
policies and regulations.
(a) How will compliance with the standards set forth in this part be
monitored and what are the consequences of noncompliance with the
standards? The federally supported chimpanzee sanctuary must comply with
the standards of care set forth in this part and include a statement in
the Annual Progress Report certifying compliance with these standards of
care in accordance with the terms of the current contract between NCRR
and the Sanctuary Contractor. A designated representative of the
Secretary will monitor compliance. The responsibility to monitor
compliance with the standards is delegated to NCRR/NIH/HHS. The NIH/NCRR
Project Officer for this contract will conduct scheduled site visits at
least one time annually (or more often if necessary) and review monthly
and quarterly reports submitted to the Project and Contract Officer.
Subcontractors are subjected to the same provisions. Failure to comply
with the standards set forth in this part, or to correct deficiencies
noted within the allowable time period, could result in termination of
the contract by the Federal Government (HHS/NIH), or allow the Secretary
to correct the deficiencies according to the terms and conditions
outlined in the contract. The Secretary may impose additional sanctions
on the contractor up to, and including, authorizing assumption or
reassignment of the management of the sanctuary contract.
(b) To what type of outside review or inspection will the federally
supported sanctuary be subjected? As noted in paragraph (a) of this
section, the contractor for the sanctuary will be monitored on a
regularly scheduled basis by representatives of NCRR/NIH/HHS. The NCRR
representative will use facility site visits, reports, personal contact,
and any other means as appropriate to ensure compliance with these
standards. The contractor and subcontractors are required to obtain and
maintain an Animal Welfare Assurance from NIH's Office of Laboratory
Animal Welfare (OLAW) when chimpanzees are used for noninvasive studies
as authorized in the CHIMP Act. In addition, the sanctuary must achieve
accreditation by a nationally recognized animal program accrediting body
(such as the AAALAC, the AZA, or similar recognized body) within a time
frame to be determined by NCRR/NIH. The federally supported sanctuary
must comply with the requirements set forth in the Animal Welfare
Regulations (9 CFR parts 1 through 3).
Sec. 9.13 Other federal laws, regulations, and statutes that apply
to the sanctuary.
(a) Animal Welfare Act (7 U.S.C. 2131-2159).
(b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2;
part 3, subpart D--Specifications for the Humane Handling, Care,
Treatment, and Transport of Nonhuman Primates.
PART 10_340B DRUG PRICING PROGRAM--Table of Contents
Sec.
Subpart A_General Provisions
10.1 Purpose.
10.2 Summary of 340B Drug Pricing Program.
10.3 Definitions.
Subpart B_Eligibility To Purchase 340B Drugs
10.10 Entities eligible to participate in the 340B Drug Pricing Program.
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Subpart C_Drugs Eligible for Purchase under 340B
10.20 Drugs eligible for purchase Under 340B.
10.21 Exclusion of orphan drugs for certain covered entities.
Authority: Sec. 340B of the Public Health Service Act (42 U.S.C.
256b), as amended; Sec. 215 of the Public Health Service Act (42 U.S.C.
216), as amended; Sec. 526 of the Federal Food, Drug, and Cosmetic Act,
as amended (21 U.S.C. 360bb); Sec. 701(a) of the Federal Food, Drug, and
Cosmetic Act, as amended (21 U.S.C. 371(a)); Sec. 1927 of the Social
Security Act, as amended (42 U.S.C. 1396r-8).
Source: 78 FR 44027, July 23, 2013, unless otherwise noted.
Subpart A_General Provisions
Sec. 10.1 Purpose.
This part implements section 340B of the Public Health Service Act
(PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.''
Sec. 10.2 Summary of 340B Drug Pricing Program.
Section 340B of the PHSA instructs the Secretary of Health and Human
Services to enter into agreements with manufacturers of covered drugs
under which the amount required to be paid to these manufacturers by
certain statutorily-defined entities does not exceed the average
manufacturer price for the drug under title XIX of the Social Security
Act (SSA) reduced by a rebate percentage which is calculated as
indicated in 340B(a)(1) and 340B(a)(2)(A). Manufacturers participating
in the 340B Drug Pricing Program (340B Program) are required to provide
these discounts on all covered outpatient drugs sold to participating
340B covered entities.
Sec. 10.3 Definitions.
Ceiling price means the maximum statutory price established under
section 340B(a)(1) of the PHSA.
Covered entity means an entity that meets the requirements under
section 340B(a)(5) of the PHSA and is listed in section 340B(a)(4) of
the PHSA.
Covered outpatient drug has the meaning set forth in section 1927(k)
of the SSA.
Group purchasing organization (GPO) is an entity that contracts with
purchasers, such as hospitals, nursing homes, and home health agencies,
to aggregate purchasing volume and negotiate final prices with
manufacturers, distributors, and other vendors.
Manufacturer has the same meaning as set forth in section 1927(k)(5)
of the SSA.
Orphan drug means a drug designated by the Secretary under section
526 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Participating drug manufacturer means a manufacturer that has
entered into a Pharmaceutical Pricing Agreement with the Secretary.
Pharmaceutical Pricing Agreement (PPA) means an agreement described
in section 340B(a)(1) of the PHSA.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human Services
to whom the authority involved has been delegated.
Section 340B means section 340B of the PHSA.
Subpart B_Eligibility To Purchase 340B Drugs