[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2005 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
42
Parts 1 to 399
Revised as of October 1, 2005
Public Health
________________________
Containing a codification of documents of general
applicability and future effect
As of October 1, 2005
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
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:
Materials Approved for Incorporation by Reference....... 821
Table of CFR Titles and Chapters........................ 825
Alphabetical List of Agencies Appearing in the CFR...... 843
List of CFR Sections Affected........................... 853
[[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.
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[[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, 2005), 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
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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
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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.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate
volumes. For the period beginning January 1, 2001, a ``List of CFR
Sections Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
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to materials already published elsewhere. For an incorporation to be
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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.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you find
the material is not available, please notify the Director of the Federal
Register, National Archives and Records Administration, Washington DC
20408, or call 202-741-6010.
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 Statutory
Authorities and Agency Rules (Table I). A list of CFR titles, chapters,
and parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
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.
[[Page vii]]
REPUBLICATION OF MATERIAL
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appearing in the Code of Federal Regulations.
INQUIRIES
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Raymond A. Mosley,
Director,
Office of the Federal Register.
October 1, 2005.
[[Page ix]]
THIS TITLE
Title 42--Public Health is composed of three volumes. The parts in
these volumes are arranged in the following order: Parts 1-399, parts
400-429 and part 430 to end. The first volume (parts 1-399) contains
current regulations issued under chapter I--Public Health Service (HHS).
The second volume (parts 400-429) includes regulations issued under
chapter IV--Centers for Medicare & Medicaid Services (HHS) and the third
volume (part 430 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, 2005.
The OMB control numbers for the Centers for Medicare & Medicaid
Services appear in Sec. 400.310 of chapter IV. For the convenience of
the user, subpart C consisting of Sec. Sec. 400.300-400.310 is
reprinted in the Finding Aids section of the third volume.
For this volume, Elmer Barksdale was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Frances D. McDonald, assisted by Alomha S. Morris.
[[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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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 [Reserved]
4 National Library of Medicine................ 31
5 Designation of health professional(s)
shortage areas.......................... 34
6 Federal tort claims act coverage of certain
grantees and individuals................ 52
7 Distribution of reference biological
standards and biological preparations... 53
8 Certification of opioid treatment program... 54
SUBCHAPTER B--PERSONNEL
21 Commissioned officers....................... 76
22 Personnel other than commissioned officers.. 86
23 National Health Service Corps............... 87
24 Senior Biomedical Research Service.......... 96
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...................... 100
32 Medical care for persons with Hansen's
disease and other persons in emergencies 105
34 Medical examination of aliens............... 106
35 Hospital and station management............. 112
37 Specifications for medical examinations of
underground coal miners................. 120
[[Page 4]]
38 Disaster assistance for crisis counseling
and training............................ 133
SUBCHAPTER D--GRANTS
50 Policies of general applicability........... 138
51 Requirements applicable to the protection
and advocacy for individuals with mental
illness program......................... 151
51a Project grants for maternal and child health 163
51b Project grants for preventive health
services................................ 166
51c Grants for community health services........ 173
51d Mental health and substance abuse emergency
response procedures..................... 188
51e-51g [Reserved]
52 Grants for research projects................ 193
52a National Institutes of Health center grants. 197
52b National Institutes of Health construction
grants.................................. 202
52c Minority Biomedical Research Support Program 210
52d National Cancer Institute Clinical Cancer
Education Program....................... 213
52e National Heart, Lung, and Blood Institute
grants for prevention and control
projects................................ 215
52h Scientific peer review of research grant
applications and research and
development contract projects........... 219
53 Grants, loans and loan guarantees for
construction and modernization of
hospitals and medical facilities........ 225
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..... 232
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...................... 236
55a Program grants for Black Lung clinics....... 241
56 Grants for migrant health services.......... 243
57 Grants for construction of teaching
facilities, educational improvements,
scholarships and student loans.......... 263
58 Grants for training of public health and
allied health personnel................. 305
59 Grants for family planning services......... 305
59a National Library of Medicine grants......... 314
[[Page 5]]
60 Health Education Assistance Loan Program.... 318
SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61 Fellowships................................. 350
62 National Health Service Corps Scholarship
and Loan Repayment Programs............. 355
63 Traineeships................................ 373
63a National Institutes of Health training
grants.................................. 376
64 National Library of Medicine training grants 380
64a Obligated service for mental health
traineeships............................ 382
65 National Institute of Environmental Health
Sciences hazardous waste worker training 386
65a National Institute of Environmental Health
Sciences hazardous substances basic
research and training grants............ 389
66 National Research Service Awards............ 393
67 Agency for Health Care Policy and Research
grants and contracts.................... 400
68a National Institutes of Health (NIH) Clinical
Research Loan Repayment Program for
Individuals from Disadvantaged
Backgrounds (CR-LRP).................... 409
68c National Institute of Child Health and Human
Development Contraception and
Infertility Research Loan Repayment
Program................................. 415
SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70 Interstate quarantine....................... 421
71 Foreign quarantine.......................... 423
72 Interstate shipment of etiologic agents..... 434
73 Select agents and toxins.................... 437
75 Standards for the accreditation of
educational programs for and the
credentialing of radiologic personnel... 453
SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED
ACTIVITIES
80 Administrative functions, practices, and
procedures.............................. 467
81 Guidelines for determining probability of
causation under the energy employees
occupational illness compensation
program act of 2000..................... 468
82 Methods for conducting dose reconstruction
under the Energy Employees Occupational
Illness Compensation Program Act of 2000 475
[[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........ 486
84 Approval of Respiratory Protective Devices.. 497
85 Requests for health hazard evaluations...... 561
85a Occupational safety and health
investigations of places of employment.. 566
86 Grants for education programs in
occupational safety and health.......... 571
87 National Institute for Occupational Safety
and Health Research and demonstration
grants.................................. 579
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS
SUBSTANCES RELEASES AND FACILITIES
90 Administrative functions, practices, and
procedures.............................. 582
93 Public health service policies on research
misconduct.............................. 586
SUBCHAPTER I [RESERVED]
SUBCHAPTER J--VACCINES
100 Vaccine injury compensation................. 615
102 Smallpox compensation program............... 620
110 [Reserved]
SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121 Organ Procurement and Transplantation
Network................................. 647
124 Medical facility construction and
modernization........................... 657
125-129 [Reserved]
SUBCHAPTER L--COMPASSIONATE PAYMENTS
130 Ricky Ray Hemophilia Relief Fund Program.... 693
131-135 [Reserved]
SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
136 Indian health............................... 726
136a Indian health............................... 758
137 Tribal self-governance...................... 766
138-199 [Reserved]
Editorial Note: Nomenclature changes to chapter I appear at 67 FR
36549, May 24, 2002.
[[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 by 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, l979, 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 proj ect 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 proj ect;
(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 [RESERVED]
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
[[Page 32]]
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).
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
[[Page 33]]
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.
(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
[[Page 34]]
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.
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
[[Page 35]]
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 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:
[[Page 36]]
(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.
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.
(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
[[Page 37]]
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 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.
[[Page 38]]
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.
(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
[[Page 39]]
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.
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
[[Page 40]]
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]
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.
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:
[[Page 41]]
(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 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
[[Page 42]]
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.
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:
[[Page 43]]
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]
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:
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
[[Page 44]]
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
(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
[[Page 45]]
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-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
[[Page 46]]
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.
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
[[Page 47]]
mental health professional(s), 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]
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.
(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.
[[Page 48]]
----------------------------------------------------------------------------------------------------------------
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.
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.
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:
[[Page 49]]
(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:
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.
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.
[[Page 50]]
(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.
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:
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:
[[Page 51]]
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./
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.
[[Page 52]]
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 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 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
[[Page 53]]
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 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.
[60 FR 22532, May. 8, 1995; 60 FR 36073, July 13, 1995]
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 Appropriation Act of 1952 (31 U.S.C. 9701);
and sec. 352 of the Public Health Service Act, as amended (42 U.S.C.
263).
Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.
[[Page 54]]
Sec. 7.1 Applicability.
The provisions of this part are applicable to private entities
requesting from the Centers for Disease Control (CDC) reference
biological standards and biological preparations for use in their
laboratories.
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 charges 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 costs 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 Biological Products Branch, Center for Infectious Diseases,
Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333.
Sec. 7.5 Payment procedures.
The requester may obtain information on terms of payment and a fee
schedule by writing the ``Centers for Disease Control,'' Financial
Management Office, Buckhead Facility, Room 200, Centers for Disease
Control, 1600 Clifton Road, Atlanta, Georgia 30333.
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.
[[Page 55]]
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 note.
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 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
[[Page 56]]
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.
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
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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.
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,
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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.
(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.
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(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 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
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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.
(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.
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(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.
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
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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.
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
[[Page 63]]
(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 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
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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 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.
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(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]
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
[[Page 66]]
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 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.
[[Page 67]]
(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 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
[[Page 68]]
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 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
following restrictions apply:
(i) During the first 90 days of treatment, the take-home supply
(beyond that of paragraph (i)(1) of this section) is limited to a single
dose each week and the patient shall ingest all other doses under
appropriate supervision as provided for under the regulations in this
subpart.
(ii) In the second 90 days of treatment, the take-home supply
(beyond that of paragraph (i)(1) of this section) is two doses per week.
(iii) In the third 90 days of treatment, the take-home supply
(beyond that of paragraph (i)(1) of this section) is three doses per
week.
(iv) In the remaining months of the first year, a patient may be
given a maximum 6-day supply of take-home medication.
(v) After 1 year of continuous treatment, a patient may be given a
maximum 2-week supply of take-home medication.
(vi) After 2 years of continuous treatment, a patient may be given a
maximum one-month supply of take-home medication, but must make monthly
visits.
(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
[[Page 69]]
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:
(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]
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.
[[Page 70]]
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 (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.
[[Page 71]]
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 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
[[Page 72]]
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 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.
[[Page 73]]
(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.
(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
[[Page 74]]
(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 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
[[Page 75]]
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.
[[Page 76]]
SUBCHAPTER B_PERSONNEL
PART 21_COMMISSIONED OFFICERS--Table of Contents
Subpart A_Definitions
Sec.
21.1 Meaning of terms.
Subpart B_Appointment
Provisions Applicable Both to Regular and Reserve Corps
21.21 Meaning of terms.
21.22 Submission of application and evidence of qualifications.
21.23 False statements as disqualification.
21.24 Physical examinations.
21.25 Eligibility; junior assistant grade.
21.26 Eligibility; assistant grade.
21.27 Eligibility; senior assistant grade.
21.28 Age requirements, Regular Corps, senior assistant grade and below.
21.29 Eligibility; grades above senior assistant grade.
21.30 Determination of creditable years of educational and professional
training and experience.
21.31 Eligibility; all grades; academic and professional education and
professional training and experience.
21.32 Boards; appointment of; powers and duties.
21.33 General service.
21.34 Certification by candidate; requirement of new physical
examination.
Provisions Applicable Only to Regular Corps
21.41 Professional examinations, holding of; subjects to be included.
21.42 Examinations; junior assistant, assistant, or senior assistant
grade.
21.43 Examination; full grade and above.
21.44 Clinical or other practical demonstration.
21.45 Rating values.
21.46 Merit roll.
21.47 Examination; anticipation of meeting qualifications.
Provisions Applicable Only to Reserve Corps
21.51 Appointment of officers having specialized training or experience
in administration and management.
21.52 Waiver of entrance qualifications for original appointment in time
of war or national emergency.
21.53 Examination.
21.54 Students.
21.55 Appointment to higher grades; candidates exceptionally qualified
in specialized fields.
21.56 Reappointment.
21.57 Examination for reappointment.
21.58 Physical examination for reappointment.
Subpart C_Involuntary Child and Spousal Support Allotments
21.70 Purpose.
21.71 Applicability and scope.
21.72 Definitions.
21.73 Policy.
21.74 Responsibilities.
21.75 Procedures.
Subpart A_Definitions
Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.
Sec. 21.1 Meaning of terms.
As used in this part, the term:
(a) Act means the Public Health Service Act, 58 Stat. 682, as now or
hereafter amended.
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Service means the Public Health Service.
(e) Surgeon General means the Surgeon General of the Public Health
Service.
(f) Commissioned officer or officer, unless otherwise indicated,
means either an officer of the Regular Corps or an officer of the
Reserve Corps.
[21 FR 9806, Dec. 12, 1956]
Subpart B_Appointment
Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216; sec.
208, 58 Stat. 685, as amended; 42 U.S.C. 209.
Source: 21 FR 9806, Dec. 12, 1956, unless otherwise noted.
Provisions Applicable Both to Regular and Reserve Corps
Sec. 21.21 Meaning of terms.
The terms approved school, approved college, approved postgraduate
school, or
[[Page 77]]
approved training course means, except as otherwise provided by law:
(a) A school, college, postgraduate school, or training course which
has been accredited or approved by a professional body or bodies
recognized by the Surgeon General for such purpose, or which, in the
absence of such a body, meets generally accepted professional standards
as determined by the Surgeon General, or
(b) In the case of a candidate who is applying for appointment as a
medical officer, any non-approved medical school provided that the
candidate has passed examinations given by a professional body or bodies
recognized by the Surgeon General for such purpose.
[24 FR 1790, Mar. 12, 1959]
Sec. 21.22 Submission of application and evidence of qualifications.
(a) Application form. Every candidate for examination for
appointment as an officer shall submit a written application on such
form as may be prescribed by the Surgeon General.
(b) Documentary evidence. The application shall be accompanied by
such documentary evidence as may be required by the Surgeon General.
Sec. 21.23 False statements as disqualification.
Willfully false statements shall be cause for rejection of the
application or, as provided in subpart N of this part, for dismissal.
Sec. 21.24 Physical examinations.
Every candidate for appointment as an officer shall undergo such
physical examination as the Surgeon General may direct, and no candidate
who is not found to be physically qualified shall be appointed as an
officer.
Sec. 21.25 Eligibility; junior assistant grade.
(a) Requirements; all candidates. Except as provided in Sec. 21.54,
and as otherwise provided in this section, every candidate for
examination for appointment in the grade of junior assistant:
(1) Shall be a citizen of the United States;
(2) Shall be at least 18 years of age; and
(3) Shall have been granted an academic or professional degree from
an approved school, college, or postgraduate school, and, unless the
required professional training has been otherwise obtained from an
approved school, college, or postgraduate school, shall have majored in
the profession in which the examination is being held.
(b) [Reserved]
(c) Special requirement; therapists. Every candidate for examination
for appointment as a therapist shall have received a certificate from an
approved school of physical therapy or an approved school of
occupational therapy.
[21 FR 9806, Dec. 12, 1956, as amended at 30 FR 9437, July 29, 1965]
Sec. 21.26 Eligibility; assistant grade.
(a) Requirements; all candidates. Except as otherwise provided in
this section every candidate for examination for appointment in the
grade of assistant:
(1) Shall meet the requirements for eligibility for examination for
appointment in the grade of junior assistant;
(2) Shall be at least 21 years of age; and
(3) Shall have had at least 7 years of educational and professional
training or experience subsequent to high school, except that a
candidate who applies for examination for appointment in the Reserve
Corps to serve as a medical or dental intern may be examined for such
appointment upon the completion of 6 years of such education, training,
or experience.
(b) Additional requirements; dietitians. Every candidate for
examination for appointment as a dietitian shall have successfully
completed an approved training course for dietetic interns.
Sec. 21.27 Eligibility; senior assistant grade.
Every candidate for examination for appointment in the grade of
senior assistant shall meet the requirements for eligibility for
examination for appointment in the grade of assistant and shall have
completed at least 10 years of educational and professional training or
experience subsequent to high school.
[[Page 78]]
Sec. 21.28 Age requirements, Regular Corps, senior assistant grade and
below.
No candidate for appointment to the Regular Corps, except in the
nurse category, shall be appointed (a) after age 31 to the permanent
junior assistant grade, (b) after age 34 to the permanent assistant
grade, or (c) after age 37 to the permanent senior assistant grade:
Provided, That the Surgeon General may waive these age limitations,
subject to other provisions of law, in the case of any officer of the
Reserve Corps who is recommended for appointment to the Regular Corps by
the Chief of the Bureau to which he is assigned and who has been on
continuous active duty for at least two years immediately preceding the
date of such recommendation. The age limitations for candidates who have
had prior active service in the Commissioned Corps of the Public Health
Service shall be increased by the period of such service.
[27 FR 3886, Apr. 24, 1962]
Sec. 21.29 Eligibility; grades above senior assistant grade.
Every candidate for examination for appointment in grades above that
of senior assistant shall meet the requirements for eligibility for
examination for appointment in the grade of senior assistant. Candidates
for examination for appointment in the full, senior, or director grade
shall have completed at least 7, 14, or 15 additional years,
respectively, of postgraduate professional training for experience. When
officers of the Service are unavailable for the performance of duties
requiring highly specialized training and experience in special fields
related to public health, the Surgeon General may specify that a
candidate for appointment to the Regular Corps with such highly
specialized training and experience shall be examined for appointment in
the full or senior grade upon completion of at least 5 or 12 additional
years, respectively, of postgraduate professional training or
experience, except that the total number of such appointments during a
fiscal year shall not exceed three.
[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]
Sec. 21.30 Determination of creditable years of educational and
professional training and experience.
The level of academic attainment, the number of calendar years and
the quality of educational and professional training and experience
shall be considered in determining the number of years of such training
and experience with which each candidate for appointment may be
credited.
[25 FR 5184, June 10, 1960]
Sec. 21.31 Eligibility; all grades; academic and professional education
and professional training and experience.
The Surgeon General is authorized, subject to the other provisions
of this subpart to adopt additional standards by which the education,
training, and experience required under this subpart, and evidence
thereof, shall be of such specific kind and quality, pertinent to the
particular profession concerned, as in his judgment are necessary to
limit the examination to qualified candidates.
[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]
Sec. 21.32 Boards; appointment of; powers and duties.
The Surgeon General shall from time to time appoint boards and
subboards of officers to consider the qualifications of candidates for
appointment as officers, and shall refer to such boards the applications
of those candidates who are eligible for examination for appointment.
Such boards and subboards shall consist of three or more officers, the
majority of whom, so far as practicable, shall be of the same profession
as the candidate. The Surgeon General shall prescribe the duties of
boards and subboards in relation to the examination process not
otherwise prescribed in this subpart.
[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]
Sec. 21.33 General service.
Officers shall be appointed only to general service and shall be
subject to change of station.
[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]
[[Page 79]]
Sec. 21.34 Certification by candidate; requirement of new physical
examination.
If a candidate for appointment in the Regular Corps or an officer of
the Reserve Corps on inactive service has passed a physical examination
within a period of one year from the date on which it is contemplated
that he will be appointed or called to active duty, he shall, prior to
being appointed or called to active duty, certify that to the best of
his knowledge and belief he is free from all disease or injury not noted
in his record at the time of his examination and that he is willing to
serve in any climate. If a candidate for appointment in the Regular
Corps, or an officer of the Reserve Corps on inactive service, has not
passed a physical examination within a period of one year from the date
on which it is contemplated that he will be appointed or called to
active duty, he may, prior to being appointed or called to active duty,
be required to undergo such physical examination as the Surgeon General
may direct to determine his physical qualification for appointment or
call to active duty in accordance with standards prescribed for original
appointment, or he may be appointed or called to active duty after
executing the certificate described in this section, but shall be
physically examined to determine his physical qualification for
continued active service in accordance with standards prescribed for
original appointment within a period of 15 days after reporting for duty
at his first station.
[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959.
Redesignated at 25 FR 5184, June 10, 1960]
Provisions Applicable Only to Regular Corps
Sec. 21.41 Professional examinations, holding of; subjects to be
included.
From time to time the Surgeon General may order examinations to be
held in such professions or specialties within professions and for such
grades as he deems necessary for the purpose of providing merit rolls of
eligible candidates for appointment in the Regular Corps and shall, if a
professional examination is to be required, prescribe the subjects
relating to each profession or specialty within such profession in which
candidates will be examined.
[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]
Sec. 21.42 Examinations; junior assistant, assistant, or senior
assistant grade.
The examination for appointment to the junior assistant, assistant,
or senior assistant grade in the Regular Corps shall consist of (a) a
written professional examination relating to the fundamentals of the
candidate's profession or specialty within his profession and their
relationship to the activities of the Service, and (b) an examination as
to the candidate's general fitness, which shall include an oral
interview, and a review and evaluation of the candidate's academic and
professional education and professional training and experience, and may
include other written tests to determine the candidate's fitness for
appointment as an officer. If an applicant for appointment to any of
these grades is an officer of the Reserve Corps who has been on active
duty for not less than one year immediately preceding his application,
the Surgeon General may direct that the officer be examined as provided
in Sec. 21.43.
[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959; 25
FR 11099, Nov. 23, 1960]
Sec. 21.43 Examination; full grade and above.
The examination for appointment to the full, senior, or director
grade in the Regular Corps shall consist of a review and evaluation of
the candidate's academic and professional education and professional
training and experience. The Surgeon General may, however, direct that
the examination of a candidate for appointment to any such grade shall
also include an oral interview, a written or oral professional
examination, or both.
Sec. 21.44 Clinical or other practical demonstration.
In the discretion of the Surgeon General a candidate for appointment
to any grade up to and including the senior assistant grade in the
Regular
[[Page 80]]
Corps may be required to perform successfully a clinical or other
practical demonstration which, if required, shall constitute a part of
the professional examination.
Sec. 21.45 Rating values.
The examination of every candidate for appointment to any grade in
the Regular Corps shall be rated by a board appointed pursuant to Sec.
21.30 in accordance with such relative values for each part of the
examination as are prescribed by the Surgeon General. No candidate who
receives a final rating below 80 shall be appointed in the Regular
Corps.
Sec. 21.46 Merit roll.
Each board appointed pursuant to Sec. 21.30 to consider the
qualifications of candidates for appointment as officers shall assign a
numerical rating to each candidate for appointment in the Regular Corps
who passes the examination, and shall submit a report to the Surgeon
General of the ratings and the relative standing of all such candidates
for each grade in each profession or specialty within a profession. The
Surgeon General shall submit each such report with his recommendations
to the Secretary, and, if approved by the Secretary, the report shall
constitute a merit roll from which the Secretary shall, in accordance
with relative standing, recommend available persons to the President for
nomination as commissioned officers of the Regular Corps. A board may
consider any newly discovered evidence relating to the physical,
professional, or personal qualifications of any candidate examined for
appointment. Upon recommendation of such board after review of such
evidence, the Surgeon General, with the approval of the Secretary, may
correct the rating of a candidate or may qualify or disqualify a
candidate. The placing of a candidate's name on a merit roll shall give
no assurance of an appointment. A merit roll shall expire when a new
merit roll in the same profession or specialty within a profession and
grade has been established, but no merit roll shall continue in effect
longer than two years after its approval by the Secretary. Every
candidate who has not been nominated by the President for appointment
prior to the expiration of a merit roll on which his name appears,
shall, unless he requests the opportunity to be reexamined, be rated
with the next group of candidates of the same profession or specialty
within a profession for appointment in the same grade and shall be given
the same rating he had on the expired merit roll. If two candidates who
were examined at the same time receive the same numerical rating the
elder candidate shall assume relative standing on the merit roll over
the younger candidate. If a candidate whose name is being transferred
from an expired to a new merit roll has the same numerical rating as a
candidate whose name is being placed on the new merit roll for the first
time, the former shall assume relative standing on the merit roll over
the latter. The name of a candidate may be removed from a merit roll in
the event that he refuses an appointment when offered. No candidate's
eligibility for appointment shall exceed two years unless he again
becomes eligible as the result of another examination.
[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]
Sec. 21.47 Examination; anticipation of meeting qualifications.
A potential candidate for appointment in any grade in the Regular
Corps may be examined within a period of nine months prior to the date
upon which it is anticipated that he will qualify for appointment under
this subpart. Upon successful completion of the examination, his name
will be entered on a merit roll. In the event that his name, in order of
relative standing among all candidates, precedes that of fully qualified
candidates, his name, for purpose of appointment, shall be passed over
in favor of fully qualified candidates until such time as he becomes
fully qualified, but in no event shall he otherwise lose his relative
standing on the merit roll, except as provided in Sec. 21.46. If the
candidate fails to qualify for appointment at the time that it was
anticipated that he would qualify, his name shall be removed from the
merit roll.
[[Page 81]]
Provisions Applicable Only to Reserve Corps
Sec. 21.51 Appointment of officers having specialized training or
experience in administration and management.
The Surgeon General may recommend for original appointment in the
Reserve Corps candidates who have specialized training or experience in
administration and management relating to the functions of the Service.
All such candidates shall be subject to the same eligibility
requirements for original appointment as are applicable to other
candidates, except that such a candidate may substitute experience in
administration or management for the requirement of professional
training or experience.
Sec. 21.52 Waiver of entrance qualifications for original appointment
in time of war or national emergency.
If, in time of war or national emergency proclaimed by the
President, the Secretary determines that there is need for commissioned
personnel to meet the needs of the Service, other than persons eligible
for examination for original appointment under the eligibility
requirements prescribed in this subpart, he may prescribe standards of
eligibility for examination for the original appointment of officers in
the Reserve Corps without regard to such eligibility requirements. Such
standards shall, however, authorize the examination only of candidates
with specialized experience in administration or management or
candidates with training or experience in fields relating to public
health. The permanent grade of an officer who becomes eligible for
examination for appointment pursuant to such standards and who becomes
eligible for appointment after passage of an examination shall be
limited to the junior assistant or the assistant grade, except that, if
upon examination a candidate is found to be exceptionally qualified for
the performance of highly specialized duties with the Service pursuant
to Sec. 21.55, he may be recommended for appointment to any grade up to
and including the director grade.
[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]
Sec. 21.53 Examination.
The examination of candidates for original appointment as officers
to any grade in the Reserve Corps shall consist of a review and
evaluation of their academic and other education and their training and
experience. In the discretion of the Surgeon General the examination of
any such candidate may include an oral interview, a written examination,
or both.
Sec. 21.54 Students.
A potential candidate for appointment in the Regular Corps who is
pursuing a course of instruction which, upon completion, would qualify
him under Sec. 21.25 or Sec. 21.26 for examination for appointment in
the junior assistant or assistant grade may be examined for and
appointed in the Reserve Corps in the junior assistant grade but shall
not be called to extended active duty until the successful completion of
such course of instruction, except that: (a) He may be called to active
duty for purposes of training for periods not to exceed 120 days during
any fiscal year, and (b) those students who have completed at least 3
years of collegiate or professional study leading to the qualifying
degree for appointment may be called to active duty for the purpose of
completing the requirements of Sec. 21.25(a)(3). An appointment made
under this subpart shall be terminated upon the officer's failure to
continue a full-time course of study or failure to meet the requirements
of Sec. 21.25(a)(3) within 18 months after entering on active duty.
[34 FR 706, Jan. 17, 1969]
Sec. 21.55 Appointment to higher grades; candidates exceptionally
qualified in specialized fields.
Any candidate eligible for examination for appointment in the grade
of assistant pursuant to Sec. 21.26 who, upon examination for such
purpose, is found
[[Page 82]]
exceptionally qualified for the performance of duties requiring highly
specialized training or experience may be recommended for appointment in
the Reserve Corps in any grade up to and including the director grade
without regard to the additional years of postgraduate training or
experience prescribed for grades above the assistant grade.
Sec. 21.56 Reappointment.
An officer of the Reserve Corps, after being examined and found
qualified for reappointment, may be recommended for reappointment to the
same grade in the event that his commission expires before he becomes
eligible for reappointment to a higher grade, or may be recommended for
reappointment to a higher grade to be effective on or after the date on
which he meets the qualifications prescribed in this subpart for
original appointment to such higher grade.
Sec. 21.57 Examination for reappointment.
The examination of an officer of the Reserve Corps on active duty
who is being considered for reappointment in such corps shall consist of
a review and evaluation of his record with the Service. The examination
of an officer of the Reserve Corps on inactive duty who is being
considered for reappointment in such corps shall consist of (a) a review
and evaluation of his record with the Service while on active duty, if
any, and (b) the record of his training or experience during the period
of his inactive duty preceding such examination. In the discretion of
the Surgeon General the examination for reappointment of an officer,
whether on active or inactive duty, may include an oral interview.
Sec. 21.58 Physical examination for reappointment.
Every officer of the Reserve Corps being considered for
reappointment shall undergo such physical examination as the Surgeon
General may direct. An officer on active duty may be recommended for
reappointment unless he is found to have a physical disability which is
determined to render him physically unfit to perform the duties of his
office under section 402 of the Career Compensation Act of 1949, as
amended. An officer may be recommended for promotion only if he meets
the physical qualifications for original appointment. If an officer is
not available to be physically examined because of circumstances which
make it impracticable for the Service to require such examination, he
may, in the discretion of the Surgeon General, be reappointed without
such examination, but shall be examined as soon thereafter as
practicable and his physical qualification or disqualification for
continued or future active service shall be determined on the same basis
as if the physical examination had been given prior to reappointment.
Subpart C_Involuntary Child and Spousal Support Allotments
Authority: 37 U.S.C. 101, 15 U.S.C. 1673, 42 U.S.C. 665.
Source: 49 FR 7235, Feb. 24, 1984, unless otherwise noted.
Sec. 21.70 Purpose.
Under references 37 U.S.C. 101, 15 U.S.C. 1673, and 42 U.S.C. 665,
this subpart provides implementing policies governing involuntary child
or child and spousal support allotments, assigns responsibilities, and
prescribes procedures.
Sec. 21.71 Applicability and scope.
(a) This subpart applies to officers in the Public Health Service
Commissioned Corps. The term ``Public Health Service,'' hereinafter
shall be referred to as Service.
(b) Its provisions pertain to officers of the Service under a call
or order to active duty for a period of six months or more.
Sec. 21.72 Definitions.
(a) Child support. Periodic payments for the support and maintenance
of a child or children, subject to and in accordance with State or local
law. This includes, but is not limited to payments to provide for health
care, education, recreation, clothing, or to meet
[[Page 83]]
other specific needs of such a child or children.
(b) Spousal support. Periodic payments for the support and
maintenance of a spouse or former spouse in accordance with State or
local law. It includes, but is not limited to, separate maintenance,
alimony pendente lite, and maintenance. Spousal support does not include
any payment for transfer of property or its value by an individual to
his or her spouse or former spouse in compliance with any community
property settlement, equitable distribution of property, or other
division of property between spouse or former spouse.
(c) Notice. A court order, letter, or similar documentation issued
by an authorized person, which provides notification that an officer has
failed to make periodic support payments under a support order.
(d) Support order. Any order providing for child or child and
spousal support issued by a court of competent jurisdiction or by
administrative procedures established under State law that affords
substantially due process and is subject to judicial review. A court of
competent jurisdiction includes Indian tribal courts within any State,
territory, or possession of the United States and the District of
Columbia.
(e) Authorized person. (1) Any agent or attorney of any State having
in effect a plan approved under part D of title IV of the Social
Security Act (42 U.S.C. 651-665), who has the duty or authority to seek
recovery of any amounts owed as child or child and spousal support
(including, when authorized under a State plan, any official of a
political subdivision); and (2) the court which has authority to issue
an order against the officer for the support and maintenance of a child,
or any agent of such court.
(f) Active duty. Full-time duty in the Service, including full-time
training duty.
(g) Legal officer. Shall be an officer of the Service or employee of
the Department who is a lawyer and who has substantial knowledge of the
regulations, policies, and procedures relating to the implementation of
section 172 of Pub. L. 97-248.
Sec. 21.73 Policy.
(a) It is the policy of the Department of Health and Human Services
to withhold allotments from pay and allowances of commissioned officers
on active duty in the Service to make involuntary allotments from pay
and allowances as payment of child, or child and spousal, support
payments when the officer has failed to make periodic payments under a
support order in a total amount equal to the support payable for two
months or longer. Failure to make such payments shall be established by
notice from an authorized person to the designated official of the
Department. Such notice shall specify the name and address of the payee
to whom the allotment is payable. The amount of the allotment shall be
the amount necessary to comply with the support order including amounts
for arrearages as well as for current support. However the amount of the
allotment, when added to any other amounts withheld from the officer's
pay pursuant to a support order, shall not exceed the limits for
involuntary allotments from pay as prescribed in section 303 (b) and (c)
of the Consumer Credit Protection Act, 15 U.S.C. 1673. An allotment
under this Subpart shall be adjusted or discontinued upon notice from
any authorized person.
(b) Notwithstanding the above, no action shall be taken to withhold
an allotment from the pay and allowances of any officer until such
officer has had an opportunity to consult with a legal officer of the
Department to discuss the legal and other factors involved with respect
to the officer's support obligation and his or her failure to make
payments. The Department shall exercise continuing good faith efforts to
arrange such a consultation, but must begin to withhold allotments on
the first end-of-month payday after 30 days have elapsed since notice of
an opportunity to consult was sent to the officer.
Sec. 21.74 Responsibilities.
(a) The General Counsel, Office of the Secretary, Department of
Health and Human Services, shall be the Designated Official for the
Department
[[Page 84]]
and shall provide guidance to the Service regarding administration of
the provisions of these regulations.
(b) The Commissioned Personnel Operations Division, Office of
Personnel Management, Office of Management, Office of the Assistant
Secretary for Health, shall implement the provisions of these
regulations.
Sec. 21.75 Procedures.
(a) Service of notice. (1) An authorized person shall serve on the
designated official of the Department a signed notice including:
(i) Full name of the officer;
(ii) Social security number of the officer;
(iii) Duty station location of the officer, if known;
(iv) A statement that support payments are delinquent by an amount
at least equal to the amount of support payable for two months;
(v) A photocopy, along with any modifications, of the underlying
support order;
(vi) A statement of the amount of arrearages provided for in the
court order and the amount which is to be applied each month toward
liquidation of the arrearages, if applicable;
(vii) The full name and address of the payee to whom the allotment
will be payable;
(viii) Any limitations on the duration of the support allotment.
(2) The service of notice shall be accomplished by certified or
registered mail, return receipt requested, or by personal service, upon
the appropriate designated official of the Department. The designated
official shall note the date and time of receipt on the notice.
(3) Valid service is not accomplished until the notice is received
in the office of the designated official.
(4) If the order of a court or duly authorized administrative agency
seeks collection of arrearages, the notice must state that the support
allotment qualifies for the additional 5 percent in excess of the
maximum percentage limitations found in 15 U.S.C. 1673. Supporting
evidence must be submitted to the Department establishing that the
support order is 12 or more weeks in arrears.
(5) When the information submitted is not sufficient to identify the
officer the notice shall be returned directly to the authorized person
with an explanation of the deficiency. However, before returning the
notice, an attempt should be made to inform the authorized person who
caused the notice to be served that it will not be honored unless
adequate information is supplied.
(6) Upon proper service of notice of delinquent support payments and
together with all required supplementary documents and information, the
Service shall identify the officer from whom moneys are due and payable.
The pay of the officer shall be reduced by the amount necessary to
comply with the support order and liquidate arrearages if any, if
provided by order of a court or duly authorized administrative agency.
The maximum amount to be alloted under the provision together with any
other moneys withheld from the officer for support pursuant to a court
order may not exceed:
(i) 50 percent of the officer's disposable earnings for any month
when the officer asserts by affidavit or other acceptable evidence that
he or she is supporting a spouse or dependent child or both, other than
a party in the support order. When the officer submits evidence, copies
shall be sent to the authorized person, together with notification that
the officer's support claim will be honored. If the support claim is
contested by the authorized person, the authorized person may refer it
to the appropriate court or other authority for resolution. Pending
resolution of a contested support claim, the allotment shall be made but
the amount of such allotment may not exceed 50 percent of the officer's
disposable earnings;
(ii) 60 percent of the officer's disposable earnings for any month
when the officer fails to assert by affidavit or other acceptable
evidence, that he or she is supporting a spouse or dependent child or
both;
(iii) Regardless of the limitations above, an additional five
percent of the officer's disposable earnings shall be withheld when it
is stated in the notice that the officer is in arrears in an amount
equivalent to 12 or more weeks' support.
[[Page 85]]
(b) Disposable earnings. (1) The following moneys, as defined in the
U.S. Public Health Service Commissioned Corps Personnel Manual, are
subject to inclusion in computation of the officer's disposable
earnings:
(i) Basic pay;
(ii) Basic allowances for quarters for officers with dependents and
officers without dependents;
(iii) Basic allowance for subsistence;
(iv) Special pay for physicians, dentists, optometrists, and
veterinarians;
(v) Hazardous duty pay;
(vi) Flying pay; and
(vii) Family separation allowances (only for officers assigned
outside the contiguous United States).
(c) Exclusions. The following moneys are excluded from the
computation of the officer's disposable earnings. Amounts due from or
payable by the United States shall be offset by any amounts:
(1) Owed by the officer to the United States.
(2) Required by law to be deducted from the remuneration or other
payment involved including but not limited to:
(i) Amounts withheld from benefits payable under title II of the
Social Security Act when the withholding is required by law;
(ii) FICA.
(3) Properly withheld for Federal and State income tax purposes if
the withholding of the amounts is authorized or required by law and if
amounts withheld are not greater than would be the case if the
individual claimed all dependents to which he or she were entitled. The
withholding of additional amounts pursuant to 26 U.S.C. 3402(i) may be
permitted only when the officer presents evidence of a tax obligation
which supports the additional withholding.
(4) Deducted for the Servicemen's Group Life Insurance coverage.
(5) Advances of pay that may be due and payable by the officer in
the future.
(d) Officer Notification. (1) As soon as possible, but not later
than 30 calendar days after the date of receipt of notice, the
Commissioned Personnel Operations Division shall send to the officer at
his or her duty station, written notice:
(i) That notice has been served, including a copy of the documents
submitted;
(ii) Of the maximum limitations set forth, with a request that the
officer submit supporting affidavits or other documentation necessary
for determining the applicable percentage limitation;
(iii) That by submitting supporting affidavits or other necessary
documentation, the officer consents to the disclosure of such
information to the party requesting the support allotment;
(iv) Of the amount of percentage that will be deducted if the
officer fails to submit the documentation necessary to enable the
designated official of the Service to respond to the legal process
within the time limits set forth;
(v) That a consultation with a legal officer is authorized and will
be provided by the Department. The name, address, and telephone number
of the legal officer will be provided;
(vi) That the officer may waive the personal consultation with a
legal officer; however if consultation is waived action will be taken to
initiate the allotment by the first end-of-month payday after
notification is received that the officer has waived his/her
consultation;
(vii) That the allotment will be initiated without the officer
having received a personal consultation with a legal officer if the
legal officer provides documentation that consultation could not be
arranged even though good faith attempts to do so had been made; and
(viii) Of the date that the allotment is scheduled to begin.
(2) The Commissioned Personnel Operations Division shall inform the
appropriate legal officer of the need for consultation with the officer
and shall provide the legal officer with a copy of the notice and other
legal documentation served on the designated official.
(3) If possible, the Commissioned Personnel Operations Division
shall provide the officer with the following:
(i) A consultation in person with the appropriate legal officer to
discuss the legal and other factors involved with
[[Page 86]]
the officer's support obligation and his/her failures to make payment;
(ii) Copies of any other documents submitted with the notice.
(4) The legal officer concerned will confirm in writing to the
Commissioned Personnel Operations Division within 30 days of notice that
the officer received a consultation concerning the officer's support
obligation and the consequences of failure to make payments. The legal
officer concerned must advise the Commissioned Personnel Operations
Division of the inability to arrange such consultation and the status of
continuing efforts to contact the officer.
(e) Lack of money. (1) When notice is served and the identified
officer is found not to be entitled to any moneys due from or payable by
the Department of Health and Human Services, the Commissioned Personnel
Operations Division shall return the notice to the authorized person,
and advise in writing that no moneys are due from or payable by the
Department of Health and Human Services to the named individual.
(2) Where it appears that moneys are only temporarily exhausted or
otherwise unavailable, the Commissioned Personnel Operations Division
shall advise the authorized person in writing on a timely basis as to
why, and for how long, the moneys will be unavailable.
(3) In instances where the officer separates from active duty, the
authorized person shall be informed in writing on a timely basis that
the allotment is discontinued.
(f) Effective date of allotment. Allotments shall be withheld
beginning on the first end-of-month payday after the Commissioned
Personnel Operations Division is notified that the officer has had a
consultation with a legal officer, has waived his/her right to such
consultation, or the legal officer has submitted documentation that a
consultation with the officer could not be arranged after good faith
attempts to do so were made by the legal officer. The Service shall not
be required to vary its normal allotment payment cycle to comply with
the notice.
(g) Designated official. Department of Health and Human Services,
General Counsel, Room 5362 North Building, 330 Independence Avenue, SW.,
Washington, DC 20201.
(Approved by the Office of Management and Budget under control number
0937-0123)
PART 22_PERSONNEL OTHER THAN COMMISSIONED OFFICERS--Table of Contents
Hansen's Disease Duty by Personnel Other Than Commissioned Officers
Sec.
22.1 Duty at a station of the Service devoted to the care of Hansen's
disease patients; additional pay.
Special Consultants
22.3 Appointment of special consultants.
22.5 Leave without pay while on detail.
Authority: Sec. 208(e) of the Public Health Service Act, 42 U.S.C.
210(e); E.O. 11140, 29 FR 1637.
Hansen's Disease Duty by Personnel Other Than Commissioned Officers
Sec. 22.1 Duty at a station of the Service devoted to the care of
Hansen's disease patients; additional pay.
(a) Non-commissioned officers and other employees of the Service
shall not receive any additional compensation by reason of being
assigned to any duty requiring intimate contact with persons with
Hansen's disease. However, any such officer or employee who was
entitled, on January 4, 1986, to receive additional pay by reason of
being assigned to full-time duty, for a period of 30 days or more, at a
station of the Service devoted to the care of Hansen's disease patients
and who continues to be assigned to such duty, shall receive special pay
as long as such assignment continues without a break.
(b) Such special pay shall, on any future date, be at an annual
dollar level equal to the lower of the levels that would be paid under
the following subparagraphs:
(1) 25% of the lowest level of basic pay that he or she has been
receiving on any date from January 4, 1986, through that future date;
(2) The amount by which the level of an employee's basic pay plus
special pay on January 4, 1986, exceeds the level of that employee's
basic pay on that on that future date, except that
[[Page 87]]
the special pay under this subparagraph shall not be less that 12 times
the monthly special pay then paid to Commissioned Officers entitled to
special pay for duty involving intimate contact with persons who have
Hansen's disease. (As of October 24, 1985, that monthly rate was $110.)
(c) An officer or employee may be paid special pay for any pay
period, under paragraphs (a) and (b) of this section, only to the extent
that it does not cause his or her aggregate pay for that pay period to
exceed the biweekly rate of basic pay for Level V of the Executive
Schedule. As used in this paragraph, ``aggregate pay'' comprises basic
pay, this special pay, and premiums for overtime, nightwork, irregular
duty, standby status, and Sunday or holiday work.
[50 FR 43146, Oct. 24, 1985]
Special Consultants
Sec. 22.3 Appointment of special consultants.
(a) When the Public Health Service requires the services of
consultants who cannot be obtained when needed through regular Civil
Service appointment or under the compensation provisions of the
Classification Act of 1949, special consultants to assist and advise in
the operations of the Service may be appointed, subject to the
provisions of the following paragraphs and in accordance with such
instructions as may be issued from time to time by the Secretary of
Health and Human Services.
(b) Appointments, pursuant to the provisions of this section, may be
made by those officials of the Service to whom authority has been
delegated by the Secretary or his designee.
(c) The per diem or other rates of compensation shall be fixed by
the appointing officer in accordance with criteria established by the
Surgeon General.
(Sec. 208(c), 58 Stat. 686, as amended; 42 U.S.C. 209(e); sec. 207(f),
58 Stat. 686 as amended by 62 Stat. 40; 42 U.S.C. 209(f))
[21 FR 9821, Dec. 12, 1956, as amended at 31 FR 12939, Oct. 5, 1966]
Sec. 22.5 Leave without pay while on detail.
The Secretary or his delegate may, pursuant to section 214(d) of the
Public Health Service Act, 42 U.S.C. 215(d), and with the consent of the
officer or employee concerned, arrange, through agreements or otherwise,
for a civilian officer or employee of the Public Health Service to be
placed on leave without pay for the period of a detail to a State, a
subdivision thereof, or a private non-profit institution and be paid by
the non-Federal organization. Such an arrangement may be for a period of
not to exceed 2 years, but may be extended for additional periods of not
to exceed 2 years each.
(Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216)
[33 FR 18981, Dec. 20, 1968]
PART 23_NATIONAL HEALTH SERVICE CORPS--Table of Contents
Subpart A_Assignment of National Health Service Corps Personnel
Sec.
23.1 To what entities does this regulation apply?
23.2 Definitions.
23.3 What entities are eligible to apply for assignment?
23.4 How must an entity apply for assignment?
23.5 What are the criteria for deciding which applications for
assignment will be approved?
23.6 What are the criteria for determining the entities to which
National Health Service Corps personnel will be assigned?
23.7 What must an entity agree to do before the assignment is made?
23.8 What operational requirements apply to an entity to which National
Health Service Corps personnel are assigned?
23.9 What must an entity to which National Health Service Corps
personnel are assigned (i.e., a National Health Service Corps
site) charge for the provision of health services by assigned
personnel?
23.10 Under what circumstances may a National Health Service Corps
site's reimbursement obligation to the Federal Government be
waived?
23.11 Under what circumstances may the Secretary sell equipment or other
property of the United States used by the National Health
Service Corps site?
23.12 Who will supervise and control the assigned personnel?
[[Page 88]]
23.13 What nondiscrimination requirements apply to National Health
Service Corps sites?
Subpart B_Private Practice Special Loans for Former Corps Members
23.21 Definitions.
23.22 What is the purpose of a private practice loan?
23.23 Who is eligible to receive a private practice option loan?
23.24 In what amounts are loans made?
23.25 How will interest rates for loans be determined?
23.26 How is the loan repaid?
23.27 What happens if scheduled payments are late?
23.28 What events constitute default?
23.29 What happens in the case of a default?
23.30 May the loan be prepaid?
23.31 May loan payments be postponed or waived?
23.32 What conditions are imposed on the use of the loan funds?
23.33 What security must be given for these loans?
23.34 What other conditions are imposed?
23.35 What criteria are used in making loans?
Subpart C_Private Startup Loans
23.41 What conditions are applicable to loans under this subpart?
Authority: Secs. 333, 338E(c), and 338C(e)(1), Public Health Service
Act. 90 Stat. 2272, as amended, 95 Stat. 905, 97 Stat. 1345 (42 U.S.C.
254f et seq.), 95 Stat. 912 (42 U.S.C. 254p(c)), 95 Stat. 910 (42 U.S.C.
254n(e)(1)).
Source: 45 FR 12790, Feb. 27, 1980, unless otherwise noted.
Subpart A_Assignment of National Health Service Corps Personnel
Sec. 23.1 To what entities does this regulation apply?
This regulation applies to the assignment of National Health Service
Corps personnel under section 333 et seq. of the Public Health Service
Act (42 U.S.C. 254f) to provide health services in or to health manpower
shortage areas as designated under section 332 of the Public Health
Service Act (42 U.S.C. 254e).
Sec. 23.2 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as amended.
Assigned National Health Service Corps personnel or Corps personnel
means health personnel of the Regular and Reserve Corps of the Public
Health Service Commissioned Corps and civilian personnel as designated
by the Secretary including, but not limited to, physicians, dentists,
nurses, and other health professions personnel who are assigned under
section 333 of the Act and this regulation.
Health manpower shortage area means the geographic area, the
population group, the public or nonprofit private medical facility or
any other public facility which has been determined by the Secretary to
have a shortage of health manpower under section 332 of the Act and its
implementing regulation (42 CFR part 5).
National Health Service Corps site means the entity to which
personnel have been assigned under section 333 of the Act and this
regulation to provide health services in or to health manpower shortage
area.
Nonprofit private entity means as entity which may not lawfully hold
or use any part of its net earnings to the benefit of any private
shareholder or individual and which does not hold or use its net
earnings for that purpose.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of that Department to whom the authority
involved has been delegated.
Sec. 23.3 What entities are eligible to apply for assignment?
Any public or nonprofit private entity which is located in a health
manpower shortage area, or has a demonstrated interest in the shortage
area, may apply for the assignment of National Health Service Corps
personnel.
Sec. 23.4 How must an entity apply for assignment?
(a) An application for the assignment of National Health Service
Corps personnel must be submitted to the Secretary by an eligibe
applicant in the form and at the time prescribed by the
[[Page 89]]
Secretary. \1\ The application must be signed by an individual
authorized to act for the applicant and to assume on behalf of the
applicant the obligations imposed by law, the Act, this regulation, and
any additional conditions of assignment imposed under these authorities.
---------------------------------------------------------------------------
\1\ Applications and instructions may be obtained from Regional
Offices of the Department of Health and Human Services at the addresses
set forth at 45 CFR 5.31(b).
---------------------------------------------------------------------------
(b) In addition to other pertinent information required by the
Secretary, an application for the assignment of Corps personnel must
include--
(1) A description of the applicant's overall organizational
structure;
(2) A justification of the request for the assignment of personnel
based upon the needs of the health manpower shortage area;
(3) A description of the applicant's financial plan for operating
the National Health Service Corps site including a proposed budget,
sources of non-Federal support obtained, and the proposed expenditures
for obtaining adequate support staff, equipment and supplies;
(4) A list of the proposed fees and discounted fees to be charged
for the provision of health services; and
(5) If an entity wishes to request an interest free loan (not to
exceed $50,000) under section 335(c) of the Act to assist the applicant
in establishing the practice of the assigned National Health Service
Corps personnel, a detailed justification of the amount requested must
be included.
(c) An application for assignment must include evidence that the
applicant has provided a copy of the completed application for review to
(1) each health systems agency designated under section 1515 of the Act
for the health service area which includes all or part of the health
manpower shortage area for which as assignment of National Health
Service Corps personnel is sought or (2) if no health systems agency has
been designated for such a health service area, to each State health
planning and development agency designated under section 1521 of the Act
for each State which includes all or part of the health manpower
shortage area for which an assignment of National Health Service Corps
personnel is sought.
(d) If an application for assignment is filed by an applicant which
had previously been assigned National Health Service Corps personnel
under an agreement entered into under section 329 of the Act as in
effect before October 1, 1977, or under section 334 of the Act, the
applicant must provide the information the Secretary considers necessary
to make the determinations required by section 333(a)(1)(D) of the Act.
[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]
Sec. 23.5 What are the criteria for deciding which applications for
assignment will be approved?
(a) In approving or disapproving an application for assignment of
Corps personnel, the Secretary will consider, among other pertinent
factors:
(1) The applicant's ability and plans to meet the operational
requirements in Sec. 23.8.
(2) The administrative and managerial capability of the applicant.
(3) The soundness of the applicant's financial plan for operating
the National Health Service Corps site.
(4) The extent to which community resources will be used in
operating the National Health Service Corps site.
(5) Comments received from any designated health systems agency or
any designated State health planning and development agency to which an
application was submitted for review under Sec. 23.4(c).
(6) Comments received from health professional societies serving the
health manpower shortage area.
(b) Special consideration for the assignment of Corps personnel will
be given to the entity which is located in a health manpower shortage
area over an entity which is not located in a health manpower shortage
area but has a demonstrated interest in it.
Sec. 23.6 What are the criteria for determining the entities to which
National Health Service Corps personnel will be assigned?
(a) The Secretary may, upon approving an application for the
assignment of personnel and after entering into an
[[Page 90]]
agreement with an applicant under Sec. 23.7, assign National Health
Service Corps personnel to provide health services in or to a health
manpower shortage area.
(b) In assigning National Health Service Corps personnel to serve in
a health manpower shortage area, the Secretary will seek to assign
personnel who have those characteristics which will increase the
probability of their remaining to serve in the health manpower shortage
area upon completion of the period of assignment. In addition, the
Secretary will apply a weighted-value system in which the first factor
listed below is assigned the greatest weight and the second, and third
factors are assigned lesser weights in descending order:
(1) The need of the health manpower shortage area as determined by
criteria established under section 332(b) of the Act.
(2) The willingness of individuals, government agencies, or health
entities within the health manpower shortage area to cooperate with the
National Health Service Corps in providing effective health services.
(3) The comments of health professional societies serving the health
manpower shortage area.
[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]
Sec. 23.7 What must an entity agree to do before the assignment is made?
(a) Requirements. To carry out the purposes of section 334 of the
Act, each National Health Service Corps site must enter into an
agreement with the Secretary under which the site agrees to:
(1) Be responsible for charging for health services provided by
assigned National Health Service Corps personnel;
(2) Take reasonable action for the collection of the charges for
those health services;
(3) Reimburse the United States the sums required under section 334
of the Act; and
(4) Prepare and submit an annual report. The agreement will set
forth the period of assignment (not to exceed 4 years), the number and
type of Corps personnel to be assigned to the site, and other
requirements which the Secretary determines necessary to carry out the
purposes of the Act.
(b) Termination. An agreement entered into under this section may be
terminated by either party on 30-days written notice or modified by
mutual consent consistent with section 333 of the Act.
[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]
Sec. 23.8 What operational requirements apply to an entity to which
National Health Service Corps personnel are assigned?
Each National Health Service Corps site must:
(a) Operate a health care delivery system within a planned or
existing community structure to assure:
(1) The provision of high quality comprehensive health care;
(2) To the extent feasible, full professional health care coverage
for the health manpower shortage area;
(3) Continuum of care; and
(4) The availability and accessibility of secondary and tertiary
health care (the two more sophisticated levels of health care beyond
primary care);
(b) Establish and maintain a patient record system;
(c) Implement a system for maintaining the confidentiality of
patient records;
(d) Meet the requirements of applicable fire and safety codes;
(e) Develop, to the extent feasible, linkages with other health care
facilities for the provision of services which supplement or complement
the services furnished by the assigned Corps personnel;
(f) Operate a quality assurance system which meets the requirements
of 42 CFR 51c.303(c) for the establishment and operation of a quality
assurance system in a community health center; and
(g) Establish basic data, cost accounting, and management
information and reporting systems as prescribed by the Secretary.
[[Page 91]]
Sec. 23.9 What must an entity to which National Health Service Corps
personnel are assigned (i.e., a National Health Service Corps site)
charge for the provision of health services by assigned personnel?
(a) Except as provided in paragraph (b) of this section, individuals
receiving services from assigned National Health Service Corps personnel
must be charged on a fee-for-service or other basis at a rate which is
computed to permit recovery of the value of the services and is approved
by the Secretary.
(b) In determining whether to approve fees to be charged for health
services, the Secretary will consider: The costs to the National Health
Service Corps of providing the health services; the costs to the health
manpower shortage area for providing the services; and the charges for
similar services by other practitioners or facilities in or nearby the
health manpower shortage area. However, if assigned National Health
Service Corps personnel are providing services within the framework of
an established health services delivery system, the Secretary may
approve the fees charged under that system without regard to the
foregoing factors.
(c)(1) No charge or a nominal charge will be made for health
services provided by assigned National Health Service Corps personnel to
individuals within the health manpower shortage area with annual incomes
at or below the ``CSA Income Poverty Guidelines'' (45 CFR 1060.2).
However, no individual will be denied health services based upon
inability to pay for the services. Any individual who has an annual
income above the ``CSA Income Poverty Guidelines,'' but whose income
does not exceed 200 percent of the CSA levels, will receive health
services at a nominal charge. However, charges will be made for services
to the extent that payment will be made by a third party which is
authorized or under legal obligation to pay the charges.
(2) The provisions of this paragraph also apply with respect to
services provided by an individual who is fulfilling an NHSC scholarship
obligation under section 753 or who received a special grant under
section 755.
Sec. 23.10 Under what circumstances may a National Health Service Corps
site's reimbursement obligation to the Federal Government be waived?
(a) The Secretary may waive in whole or in part the reimbursement
requirements of section 334(a)(3) of the Act if he determines that:
(1) The National Health Service Corps site is financially unable to
meet the reimbursement requirements or that compliance with those
requirements will unreasonably limit the ability of the site to
adequately support the provision of services by assigned Corps
personnel. In making these determinations, the Secretary will consider--
(i) The costs necessary to adequately support the health services
provided by the assigned National Health Service Corps personnel and the
income and financial resources available to meet the costs;
(ii) The ability of the applicant to obtain credit from suppliers,
lending institutions, private organizations and individuals;
(iii) The need of the health manpower shortage area for health
services; and
(iv) The extent to which the National Health Service Corps site
utilizes health professions personnel.
(2) A significant percentage of the individuals who are located in
the health manpower shortage area and are receiving the health services
of the assigned National Health Service Corps personnel are elderly,
living in poverty, or have other characteristics which indicate an
inability to pay. For purposes of this section, ``elderly'' means
persons 65 years or older and the ``CSA Income Poverty Guidelines'' will
be used as the standard for determining whether individuals are living
in poverty. Other characteristics indicating inability to pay include,
but are not to be limited to, the ratio of unemployment in the health
manpower shortage area and the area's cost-of-living index.
(b) The Secretary may waive in whole or in part the reimbursement
requirements of section 334(f)(1) of the Act if he or she determines
that the National Health Service Corps site is a small health center (as
defined by section 334(f)(5) of the Act) that needs all
[[Page 92]]
or part of the amount otherwise payable to--
(1) Expand or improve its provision of health services;
(2) Increase the number of individuals served;
(3) Renovate or modernize facilities for its provision of health
services;
(4) Improve the administration of its health service programs; or
(5) Establish a financial reserve to assure its ability to continue
providing health services;
(c) Where the Secretary determines that a National Health Service
Corps site is eligible for a waiver under paragraph (a) (1) or (2) of
this section. the Secretary may waive the application of the
reimbursement requirements of section 334(a)(3) of the Act and apply the
reimbursement requirements of section 334(f)(1) of the Act. The
Secretary may waive in whole or in part the reimbursement requirements
of section 334(f)(1) for such a site if he or she determines that the
National Health Service Corps site meets the requirements of paragraph
(a)(1) of this section. Funds retained by a National Health Service
Corps site as a result of such waiver must be used for the purposes set
forth in paragraphs (b) (1) through (5) of this section.
(d) Requests for a prospective or retrospective waiver must be made
at the time and in the manner and contain the documentation prescribed
by the Secretary.
[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]
Sec. 23.11 Under what circumstances may the Secretary sell equipment or
other property of the United States used by the National Health Service
Corps site?
(a) Upon expiration of the assignment of all Corps personnel to a
health manpower shortage area, the Secretary may sell equipment and
other property of the United States used by the assigned personnel. The
equipment may be sold at the fair market value or less than the fair
market value to any entity providing health services in or to a health
manpower shortage area if the Secretary determines that an entity is
unable to pay the fair market value. In determining whether an entity is
financially unable to purchase equipment or property at fair market
value, the Secretary will consider (1) the present financial resources
of the entity available to purchase the equipment or property based upon
its current liabilities, and (2) the entity's ability to obtain the
funds necessary to purchase the equipment or property. However, the
Secretary will not sell the equipment or property for less than fair
market value to a profitmaking organization unless the organization
gives reasonable assurance that it will use the equipment or property to
provide health services in or to the health manpower shortage area.
(b) The Secretary will give priority to sales to an entity providing
reasonable assurance that it will use the equipment or property for the
purpose of retaining within the health manpower shortage area National
Health Service Corps personnel who have completed their assignments.
Sec. 23.12 Who will supervise and control the assigned personnel?
Assigned National Health Service Corps personnel will at all times
remain under the direct supervision and control of the Secretary.
Observance of institutional rules and regulations by the assigned
personnel is a mere incident of the performance of their Federal
functions and does not alter their direct professional and
administrative responsibility to the Secretary.
Sec. 23.13 What nondiscrimination requirements apply to National
Health Service Corps sites?
National Health Service Corps sites are advised that in addition to
complying with the terms and conditions of this regulation, the
following laws and regulations are applicable--
(a) Title VI of the Civil Rights Act of 1964 (43 U.S.C. 2000d et
seq.) and its implementing regulations, 45 CFR part 80 (prohibiting
discrimination in federally assisted programs on the grounds of race,
color, or national origin); and
(b) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794)
and its implementing regulations, 45 CFR part 84 (prohibiting
discrimination in federally assisted programs on the basis of handicap).
[[Page 93]]
(c) The Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.) and
its implementing regulations, 45 CFR part 91 (prohibiting
nondiscrimination on the basis of age in HHS programs or activities
receiving Federal financial assistance).
[45 FR 12790, Feb. 27, 1980, as amended at 49 FR 38109, Sept. 27, 1984]
Subpart B_Private Practice Special Loans for Former Corps Members
Source: 51 FR 31948, Sept. 8, 1986, unless otherwise noted.
Sec. 23.21 Definitions.
As used in this subpart, terms have the same meanings as those given
to them in subpart A, Sec. 23.2. In addition:
National Health Service Corps scholarship recipient means an
individual receiving a scholarship under the Public Health and National
Health Service Corps Scholarship Training Program authorized by section
225 of the Act as in effect on September 30, 1977, and repealed on
October 1, 1977, or a scholarship under the NHSC Scholarship Program
authorized by section 338A of the Act, formerly section 751 of the Act.
Private full-time clinical practice means the provision of
ambulatory clinical services for a minimum of 40 hours per week for at
least 45 weeks a year, including the provision of hospital coverage
services appropriate to meet the needs of patients treated and to assure
continuity of care. The 40 hours per week must be performed in no less
than 4 days per week with no more than 12 hours of work being performed
in any 24-hour period.
Sec. 23.22 What is the purpose of a private practice loan?
The purpose of the private practice loan is to assist NHSC
scholarship recipients in establishing private full-time clinical
practices in designated health manpower shortage areas.
Sec. 23.23 Who is eligible to receive a private practice option loan?
(a) Eligibility for loans is limited to NHSC scholarship recipients
who have completed at least 2 years of their service obligations at a
NHSC site. NHSC scholarship recipients remain eligible for loans under
this subpart for 1 year after they have completed their service
obligations at a NHSC site.
(b) Scholarship recipients who are in arrears 31 days or more on a
Health Professions Student Loan (42 U.S.C. 294m et seq.), Health
Education Assistance Loan (42 U.S.C. 294, et seq.), Nursing Student Loan
(42 U.S.C. 297a et seq.), or any other Federally guaranteed or direct
student loan are ineligible for this loan program.
(c) NHSC scholarship recipients who have received loans under either
this subpart or subpart C of this part are ineligible for loans under
this subpart.
Sec. 23.24 In what amounts are loans made?
The Secretary may make loans either in the amount of $12,500, if the
recipient agrees to practice in accordance with the loan agreement for a
period of at least 1 year but less than 2 years, or $25,000, if the
recipient agrees to practice in accordance with the loan agreement for a
period of at least 2 years.
Sec. 23.25 How will interest rates for loans be determined?
Interest will be charged at the Treasury Current Value of Funds
(CVF) rate in effect on April 1 immediately preceding the date on which
the loan is approved and will accrue from the date the loan funds are
disbursed to the borrower.
Sec. 23.26 How is the loan repaid?
Payments shall be made at monthly intervals, beginning 1 month from
the date of the loan disbursement, in accordance with the repayment
schedule established by the Secretary and set forth in the loan
agreement. Only interest payments are required during the first 2 years.
The repayment schedule may be extended in accordance with Sec.
23.31(a).
Sec. 23.27 What happens if scheduled payments are late?
(a) Failure to make full payment of principal and/or interest when
due will subject the borrower to the assessment of administrative costs
and penalty
[[Page 94]]
charges, in addition to the regular interest charge, in accordance with
45 CFR part 30.
(b) Failure to make full payment of principal and/or interest when
due may result in the Secretary placing the borrower in default of the
loan. See Sec. 23.28(a).
Sec. 23.28 What events constitute default?
The following events will constitute defaults of the loan agreement:
(a) Failure to make full payment of principal and/or interest when
due, and continuance of that failure for a period of sixty (60) days, or
a lesser period of time if the Secretary determines that more immediate
action is necessary in order to protect the interests of the Government.
(b) Failure to perform or observe any of the terms and conditions of
the loan agreement and continuance of that failure for a period of sixty
(60) days.
(c) The institution of bankruptcy proceedings, either voluntary or
involuntary, under any State or Federal statute, which may adversely
affect the borrower's ability to comply with the terms and conditions of
the agreement or the promissory note.
Sec. 23.29 What happens in the case of a default?
(a) In the event of default, the Secretary may declare the entire
amount owed (including principal, accrued interest and any applicable
charges) immediately due and payable. Collection of the amount owed will
be made in accordance with 45 CFR part 30.
(b) The borrower is not entitled to written notice of any default
and the failure to deliver written notice of default in no way affects
the Secretary's right to declare the loan in default and take any
appropriate action under the loan agreement or the promissory note.
(c) The failure of the Secretary to exercise any remedy available
under law or regulation shall in no event be construed as a waiver of
his or her right to exercise that remedy if any subsequent or continued
default or breach occurs.
Sec. 23.30 May the loan be prepaid?
The borrower shall have the option to prepay the balance of any part
of the loan, together with accrued interest, at any time without
prepayment penalty.
Sec. 23.31 May loan payments be postponed or waived?
(a) Whenever health, economic, or other personal problems affect the
borrower's ability to make scheduled payments on the loan, the Secretary
may allow the borrower an extension of time or allow the borrower to
make smaller payments than were previously scheduled; however, interest
will continue to accrue at the rate specified in the promissory note
until the loan is repaid in full. The loan must be fully repaid within
10 years after it was made.
(b) No waiver, full or partial, of repayment of the loan will be
granted; except that the obligation of a borrower to repay a loan shall
be cancelled upon the death or total and permanent disability of the
borrower, as determined by the Secretary.
(c) In order to make a determination under paragraph (a) or (b) of
this section, the Secretary may require supporting medical, financial,
or other documentation.
Sec. 23.32 What conditions are imposed on the use of the loan funds?
(a) The borrower must use the total amount of the loan to purchase
or lease, or both, equipment and supplies, to hire authorized personnel
to assist in providing health services and/or to renovate facilities for
use in providing health services in his or her private practice.
Equipment and supplies purchased and/or leased, personnel hired and
facilities renovated shall be limited to the items requested in the loan
application and approved by the Secretary.
(b) The borrower must expend the loan funds within 6 months from the
date of the loan or within such other time as the Secretary may approve.
Documentation of the expenditure of funds must be furnished to the
Secretary upon request.
Sec. 23.33 What security must be given for these loans?
The Secretary may require the borrower to pledge to the Secretary a
security interest in specified collateral.
[[Page 95]]
Sec. 23.34 What other conditions are imposed?
(a) The borrower must sign a loan agreement describing the loan and
practice conditions, and a promissory note agreeing to repay the loan
plus interest.
(b) The borrower must agree to enter into private full-time clinical
practice in a HMSA for the time period specified in the loan agreement.
(c) The borrower must accept assignment, for the time period
specified in the loan agreement, under section 1842(b)(3)(B)(ii) of the
Social Security Act as full payment for all services for which payment
may be made under part B of title XVIII of that Act.
(d) The borrower must enter into an appropriate agreement, for the
time period specified in the loan agreement, with the State agency which
administers the State plan for medical assistance under title XIX of the
Social Security Act to provide services to individuals entitled to
medical assistance under the plan.
(e) During the time period specified in the loan agreement, the
borrower must provide health services to individuals at the usual and
customary rate prevailing in the HMSA in which services are provided;
however, services must be provided at no charge or at a nominal charge
to those persons unable to pay for these services.
(f) The borrower must keep and preserve all documents, including
bills, receipts, checks, and correspondence which affect the operation
of the private practice and the expenditure of loan funds for the period
of the practice obligation specified in the loan agreement plus 3 years.
Accounts will be maintained under one of the accounting principles
identified by the Secretary in the loan agreement.
(g) The borrower must provide the Secretary and the Controller
General of the United States, or their representatives, access during
normal working hours to accounts, documents, and records for the
purposes of audit or evaluation; and must permit the Secretary or his or
her representative to inspect the private practice at reasonable times
during the period of the practice obligation specified in the loan
agreement plus 3 years. All information as to personal facts and
circumstances about recipients of services shall be held confidential,
and shall not be divulged without the individual's consent except as may
be required by law or as may be necessary to provide medical service to
the individual or to provide for medical or fiscal audits by the
Secretary or his or her designee with appropriate safeguards for
confidentiality of records.
(h) For the entire period of loan repayment, the borrower must
acquire, maintain, and when requested, must provide the Secretary with
copies of policies of insurance on equipment and supplies in amounts
adequate to reasonably protect the borrower from risk, including public
liability, fire, theft, and worker's compensation.
(i) If the Secretary retains a security interest pursuant to Sec.
23.33, the borrower must keep and preserve all documents which affect
that security interest for the period of the loan repayment and allow
the Secretary or his or her designee access, during normal working
hours, to those documents.
(j) The borrower must maintain the loan proceeds in a separate
account from his or her other transactions and must agree to draw upon
this account and expend the loan proceeds in accordance with Sec.
23.32.
(k) The Secretary may impose other conditions which he or she deems
appropriate under law or regulation to protect the Government's
interests.
Sec. 23.35 What criteria are used in making loans?
Approval of loan applications will be based on the criteria set
forth below:
(a) The need in the HMSA for the applicant's health profession as
determined under section 332 of the Act;
(b) The applicant's need for the loan funds; and
(c) The comments from State or local health professional societies
on the appropriateness of the applicant's intended private practice; and
(d) The applicant's credit worthiness and projected financial
ability to repay the loan.
[[Page 96]]
Subpart C_Private Startup Loans
Sec. 23.41 What conditions are applicable to loans under this subpart?
The regulations set out in subpart B of this part are fully
applicable to loans awarded under section 338C(e)(1) of the Public
Health Service Act, except as noted below;
(a) Eligibility. (1) In lieu of Sec. 23.23(a), the following
applies to loans made under this subpart:
(i) Eligibility for loans is limited to NHSC scholarship recipients
who plan to enter private practice and have not begun fulfilling their
scholarship service obligation or are currently fulfilling their
scholarship service obligation under section 338B of the Act and have
completed less than 2 years of this obligation.
(2) In lieu of Sec. 23.23(c), the following applies to loans made
under this subpart:
(i) NHSC scholarship recipients who have received loans under either
this subpart or subpart B of this part are ineligible for loans under
this subpart.
(b) Loan amounts. (1) In lieu of Sec. 23.24, the following applies
to loans made under this subpart:
(i) The Secretary may make loans in the amount of $12,500 if the
recipient agrees to practice in accordance with the loan agreement for a
period of at least 1 year but less than 2 years or the remaining period
of the borrower's NHSC scholarship service obligation, whichever is
shorter.
(ii) The Secretary may make loans in the amount of $25,000 if the
recipient agrees to practice in accordance with the loan agreement for a
period of at least 2 years or the remaining period of the borrower's
NHSC scholarship service obligation, whichever is shorter.
(c) Use of funds. (1) In lieu of Sec. 23.32(a), the following
applies to loans made under this subpart:
(i) The borrower must use the total amount of the loan only to
purchase or lease, or both, the equipment and supplies needed for
providing health services in his or her private practice. Equipment and
supplies purchased and/or leased shall be limited to the items requested
in the loan application and approved by the Secretary.
[51 FR 31950, Sept. 8, 1986]
PART 24_SENIOR BIOMEDICAL RESEARCH SERVICE--Table of Contents
Sec.
24.1 Establishment.
24.2 Allocation.
24.3 Policy Board.
24.4 Eligibility.
24.5 Peer review.
24.6 Pay and compensation.
24.7 Performance appraisal system.
24.8 Applicability of provisions of Title 5, U.S. Code.
24.9 Removal from the Service.
24.10 Reporting.
Authority: Section 228(g) of the Public Health Service Act; 5 U.S.C.
301.
Source: 61 FR 6557, Feb. 21, 1996, unless otherwise noted.
Sec. 24.1 Establishment.
There is established in the Public Health Service (PHS) a Senior
Biomedical Research Service (SBRS) consisting of members the maximum
number of which is prescribed by law.
Sec. 24.2 Allocation.
(a) The Secretary, within the number authorized in the PHS Act,
shall determine the number of SBRS slots to be allocated to each
participating Operating Division.
(b) The SBRS Policy Board may advise the Secretary to make
adjustments to the allocation at any time.
(c) The majority of the SBRS allocation is to be reserved for
recruitment. The remaining SBRS allocation may be used for the retention
of current employees.
(d) SBRS slots will be used judiciously, resulting in SBRS
appointments only where other senior-level appointing authorities are
not sufficient to recruit or retain scientific talent.
(e) The Secretary will ensure that SBRS slots are used in support of
high priority programs authorized by Congress and which directly support
the research goals and priorities of the Department.
Sec. 24.3 Policy Board.
The Secretary or his/her designee shall establish an SBRS Policy
Board to serve in an advisory capacity, recommending SBRS allocations
among the participating Operating Divisions,
[[Page 97]]
reviewing the operations of the SBRS and ensuring consistent application
of regulations, policies, and procedural guidelines, and recommending
changes to the Secretary as necessary. Membership, to the extent
possible, will include SBRS eligibles nominated by their respective
Operating Divisions, will be weighted in proportion to Operating
Divisions' SBRS allocations, and will include representation from the
Office of the Secretary. The Secretary or his/her designee will select
the board membership and the Chair.
Sec. 24.4 Eligibility.
To be eligible for appointment to the Service an individual must
have a doctoral-level degree in biomedicine or a related field and must
meet the qualification standards prescribed by the U.S. Office of
Personnel Management for appointment to a position at GS-15 of the
General Schedule. In addition, the individual must be outstanding in the
field of biomedical research or clinical research evaluation.
Appointment to the Service will be made only to individuals actively
engaged in either biomedical research or clinical research evaluation.
(a) Outstanding in the field of biomedical research means an
individual who is actively engaged in peer-reviewed original biomedical
research and whose work in this area is considered by his or her peers
to be outstanding. In order to meet the eligibility criteria, an
individual must have conducted original peer-reviewed biomedical
research resulting in major accomplishments reflected by a steady and
current record of highly cited publications in peer-reviewed journals of
high stature. In addition, the individual should be the recipient of
major prizes and awards (such as visiting professorships and named
lectureships) in recognition of original contributions to research.
(b) Outstanding in the field of clinical research evaluation means
that an individual is actively engaged in clinical research evaluation
and is considered by his or her peers to be outstanding. In order to
meet the eligibility criteria, an individual, by force of his or her own
technical expertise, must be in a position to shape the course of drug
or device evaluation or exert a similar influence on the PHS handling of
other agents that may affect the public health. The individual would
normally have dealt with complex, precedent-setting evaluation issues
that involved significant scientific controversy, had far reaching
implications for clinical research or resulted in a widespread economic
effect in the health-care delivery system. In addition, the individual
should have been involved in the development of scientific or regulatory
guidelines for clinical research and been the recipient of invitations
to speak at or to chair major national or international meetings and
symposia.
Sec. 24.5 Peer review.
An individual may not be considered for appointment into the SBRS
unless his/her qualifications have been reviewed by a PHS peer review
committee and the committee has recommended appointment to the Service.
Sec. 24.6 Pay and compensation.
The SBRS is an ungraded system, with a single, flexible pay range to
include all members.
(a) Pay of the members of the Service shall be determined by the
Secretary or his/her designee.
(b) The pay of a member of the Service shall be not less than the
minimum rate payable for GS-15 of the General Schedule and shall not
exceed:
(1) The rate payable for level I of the Executive Schedule unless a
higher rate of pay is expressly approved on an individual basis by the
President, pursuant to 5 U.S.C. 5377(d)(2), or
(2) The rate payable for level II of the Executive Schedule unless a
higher rate of pay is expressly approved on an individual basis by the
Secretary.
(c) While the full pay range will be used, individual pay at the
higher end of the range will be used only as needed to recognize
individual scientific value and as necessary to recruit or retain an
exceptionally well-qualified scientist.
(d) The following factors will be used in establishing appropriate
pay rates for individual members:
(1) Impact of the individual on the scientific field;
[[Page 98]]
(2) Recognition of the individual by the scientific community;
(3) Originality of the individual's ideas/work products;
(4) Specific ``clinical'' or highly technical skills of the
individual which are of benefit to the agency and which are in addition
to requirements of the basic scientific assignment;
(5) The individual's earnings and monetary benefits;
(6) Salary surveys of similar skills in pertinent labor markets; and
(7) Other relevant factors.
(e) Annual adjustments to pay rates may be made effective on the
first day of the first pay period on or after January 1 of each calendar
year. The rate of such adjustments will be at the discretion of the
Secretary or his/her designee, except that the minimum rate payable in
the SBRS will be increased to the amount of the minimum rate of the GS-
15 of the General Schedule.
(f) Other pay adjustments will be made on an individual basis by the
Secretary or his/her designee.
(g) Except as provided in paragraph (h) of this section, new
appointees to the Service, who are not covered by the Civil Service
Retirement System, will be covered by the Federal Employees Retirement
System.
(h) Upon the request of a member who performed service in the employ
of an institution of higher education immediately prior to his
appointment as a member of the Service, and retains the right to make
contributions to the retirement system of such institution, the
Department of Health and Human Services may contribute an amount not to
exceed ten percent per annum of the member's basic pay to such
institution's retirement system on behalf of such member. A member who
participates in this program shall not be covered by any retirement
system established for employees of the United States under title 5,
United States Code.
Sec. 24.7 Performance appraisal system.
The members of the Service shall be subject to a performance
appraisal system which shall be designed to encourage excellence in
performance and shall provide for a periodic and systematic appraisal of
the performance of the members.
Sec. 24.8 Applicability of provisions of Title 5, U.S. Code.
(a) Appointments to the Service shall be made without regard to the
provisions of title 5, U.S. Code regarding appointments.
(b) Members of the Service shall not be covered by the following
provisions of title 5, U.S. Code:
(1) Subchapter I of Chapter 35 (relating to retention preference in
the event of reduction in force);
(2) Chapter 43, Performance Appraisal (and performance-based
actions);
(3) Chapter 51 (relating to classification);
(4) Subchapter III of Chapter 53, The General Schedule; and
(5) Chapter 75, Adverse Actions.
(c) Other provisions of Title 5 will be applied as administratively
determined by the Secretary or his/her designee.
Sec. 24.9 Removal from the Service.
(a) A member of the Service may be subject to disciplinary action,
including removal from the Service, for substandard performance of duty
as a member of the service, for misconduct, for reasons of national
security or for other reasons as determined by the Secretary.
(b) A member for whom disciplinary action is proposed is entitled
to:
(1) Written notice of the proposed action and the basis therefor;
(2) A reasonable opportunity to answer the notice of proposed action
both orally and in writing;
(3) The right to be represented by an attorney or other
representative in making such answer; and
(4) A written decision on the proposal.
(c) The decision may be made by an official with delegated authority
to take such action, but in no case may the official be at a level below
the head of the Operating Division where the member is assigned.
(d) A member who is separated from the Service involuntarily and
without cause and who, immediately prior to his appointment to the
Service, was a career appointee in the civil service or the Senior
Executive Service, may be
[[Page 99]]
appointed to a position in the competitive civil service at grade GS-15
of the General Schedule. Such an appointment may be made by the
Secretary or his/her designee without regard to the provisions of title
5, U.S. Code regarding appointments in the civil service.
(e) A member who is separated from the Service involuntarily and
without cause and who, immediately prior to appointment to the Service,
was not a career appointee in the civil service or the Senior Executive
Service may be appointed to a position in the excepted civil service at
grade GS-15 of the General Schedule for a period not to exceed two
years.
(f) There shall be no right to further review of the final decision
on a disciplinary action. At his/her discretion, the Secretary may
review an action taken under this section and may reduce, suspend, or
overrule the action taken.
(g) A member of the Service may be removed from the Service for such
other reasons as may be prescribed by the Secretary.
Sec. 24.10 Reporting.
For each quarter of the first year of implementation and annually
thereafter, participating Operating Divisions shall maintain reports on
the operation of the SBRS. At a minimum, these reports should include
the number of appointees, the source of those appointees, their earnings
immediately prior to appointment, and their SBRS pay at appointment.
[[Page 100]]
SUBCHAPTER C_MEDICAL CARE AND EXAMINATIONS
PART 31_MEDICAL CARE FOR CERTAIN PERSONNEL OF THE COAST GUARD, NATIONAL
OCEAN SURVEY, PUBLIC HEALTH SERVICE, AND FORMER LIGHTHOUSE SERVICE--Table
of Contents
Definitions
Sec.
31.1 Meaning of terms.
Provisions Applicable to Coast Guard, National Ocean Survey and Public
Health Service
31.2 Persons entitled to treatment.
31.3 Use of Service facilities.
31.4 Use of other than Service facilities.
31.5 Application for treatment; active duty personnel.
31.6 Personnel absent without leave.
31.7 Continuance of medical relief after loss of status.
31.8 Retired personnel; extent of treatment.
31.9 Dependent members of families; treatment.
31.10 Dependent members of families; use of Service facilities.
Provisions Applicable to Personnel of Former Lighthouse Service
31.11 Persons entitled to treatment.
31.12 Use of Service facilities.
31.13 Use of other than Service facilities.
31.14 Application for treatment; active duty personnel.
31.15 Continuance of medical relief after loss of status.
31.16 Retired personnel; extent of treatment.
Source: 21 FR 9821, Dec. 12, 1956, unless otherwise noted.
Definitions