[Federal Register Volume 60, Number 88 (Monday, May 8, 1995)]
[Rules and Regulations]
[Pages 22530-22532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11217]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 6


Federally Supported Health Centers Assistance Act of 1992

AGENCY: Public Health Service, HHS.

ACTION: Final rule.

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SUMMARY: The Secretary of Health and Human Services (the 
``Secretary''), in consultation with the Attorney General, issues the 
following rules under the ``Federally Supported Health Centers 
Assistance Act of 1992.'' The Act provides for liability protection for 
certain health care professionals and entities. This rules sets forth 
information whereby an entity or a person can determine when, and the 
extent to which, it is likely to be protected under the Act.

EFFECTIVE DATE: May 8, 1995.

FOR FURTHER INFORMATION CONTACT:
Richard C. Bohrer, Director, Division of Community and Migrant Health, 
Bureau of Primary Health Care, Health Resources and Service 
Administration, 4350 East/West Highway, Bethesda, Maryland 20814, 
Phone: (301) 594-4300.

SUPPLEMENTARY INFORMATION: Section 224(a) of the Public Health Service 
Act (the Act), (section 233(a) of Title 42 of the United States Code), 
provides that the remedy against the United States provided under the 
Federal Tort Claims Act (FTCA) resulting from the performance of 
medical, surgical, dental or related functions by any commissioned 
officer or employee of the Public Health Service while acting within 
the scope of his office or [[Page 22531]] employment shall be exclusive 
of any other civil action or proceeding. Public Law 102-501 provides 
that, subject to its provisions, certain entities and officers, 
employees and contractors of entities shall be deemed to be employees 
of the Public Health Service within the exclusive remedy provision of 
section 224(a). This rule implements certain provisions of Public Law 
102-501.
    On August 19, 1994, the Secretary published a Notice of Proposed 
Rulemaking in the Federal Register (59 FR 42790) to implement Public 
Law 102-501. The deadline for the submission of comments was September 
19, 1994.

Changes to Proposed Regulations

    Section 6.6(d) of the proposed rule provides that 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 provision of such services will benefit the community 
served by the entity; facilitate the provision of services to patients 
of the entity; or are otherwise required to be provided under an 
employment contract or similar arrangement between the entity and the 
covered individual.
    The final rule adds a new Sec. 6.6(e) which lists examples of 
services to individuals who are not patients of a covered entity that 
will be covered under Sec. 6.6(d).

Response to Comments

    We received six comment letters: two from groups representing 
interested organizations, one from a U.S. Senator, and three from 
Community Health Centers. A discussion of these comments and our 
responses follow.
    Comment 1: Three commenters wrote to express support for the 
proposed rule.
    Comment 2: Two commenters expressed concern regarding coverage for 
services provided off-site and to persons not registered with the 
Center. One commenter requested that such coverage be guaranteed for 
providers. Another provider requested clarification regarding when a 
patient becomes a CHC enrolled patient.
    Response: It is not feasible to determine in advance of an actual 
claim whether all of the activities of a provider are covered under 
FTCA, since the individual is covered only for activities within the 
scope of employment with the health center and activities within the 
scope of the approved Federal grant project. This is consistent with 
the treatment of Federal employees under the FTCA. Moreover, this rule 
is not intended to constitute, and does not constitute, a comprehensive 
notice pertaining to any provision of Pub. L. 102-501 except to the 
extent that procedures pertaining to implementation of Pub. L. 102-501 
are described explicitly therein. The applicability of Pub. L. 102-501 
and 42 U.S.C. 233(a) to a particular claim or case will depend upon the 
determination or certification (as appropriate) by the Attorney General 
that the individual or entity is covered by Pub. L. 102-501 and was 
acting within the scope of employment, in accordance with normal 
Department of Justice procedures.
    However, we agree with the commenter regarding the need for 
additional clarification regarding coverage for services provided off-
site and to persons not registered with the Center. Thus, we have added 
a new Sec. 6.6(e) to the regulations, including the examples set forth 
in the preamble to the Notice of Proposed Rulemaking. This will provide 
in codified form guidance on coverage of common arrangements. In 
drafting this rule, we cannot foresee every possible situation, 
however, so covered entities and covered individuals who are uncertain 
whether their treatment of individuals who are not patients of the 
covered entity will be within the protection afforded by Public Law 
102-501 should apply to the Secretary for a specific determination 
under Sec. 6.6(d).
    Comment 3: One commenter requested that the regulation provide for 
consultative and risk management functions.
    Response: We did not address these functions in the regulation 
because they are not addressed in the statute being implemented, and 
because we currently provide assistance in these areas as a part of our 
management of the relevant grant programs. In addition to the on-going 
technical assistance available to address risk management and Quality 
Assurance issues, we are considering enhancing the scope and diversity 
of such activities.
    Comment 4: One commenter expressed concern about its ability to 
take advantage of FTCA coverage unless Congress extends the coverage 
past December 31, 1995.
    Response: This is not an issue under the scope of the regulation. 
However, we anticipate that Congress will consider an extension of the 
program next year. We have accordingly removed the reference to a 
specific date from section 6.6(a), so that should Congress extend the 
program, no further change to the rule will be needed.

Waiver of Delay in Effective Date

    This final rule is effective ``upon issuance''. The Secretary has 
found that good cause exists to waive the requirement under the 
Administrative Procedure Act (5 U.S.C. 553(d)) that the effective date 
for a regulation be not less than 30 days from the date of publication. 
It is cost effective to permit health centers to take advantage of the 
statutory liability protection that is clarified by these regulations 
at the earliest possible date. Until these regulations are effective, 
health centers will continue to pay private insurance premiums for 
liability protection that is provided for under the FTCA.

Economic Impact

    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, benefits, incentives, equity, 
and availability of information. Regulations which are ``significant'' 
because of cost, adverse effects on the economy, inconsistency with 
other agency actions, effects on the budget, or novel legal or policy 
issues, require special analysis. In addition, the Regulatory 
Flexibility Act of 1980 requires that we include an analysis of all 
rules that significantly impact small businesses.
    These regulations provide information whereby health care entities 
or individuals can determine when, and to what extent, they are likely 
to be protected against certain malpractice claims under the FTCA. 
Therefore, the Secretary certifies that these regulations are not 
significant under Executive Order 12866 and that they will not have a 
significant effect on a substantial number of small entities. For this 
reason, a regulatory analysis is not required.

Paperwork Reduction Act of 1980

    This rule contains no information collection or reporting 
requirements which are subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1980.

List of Subjects in 42 CFR Part 6

    Grant programs--Health.

    Dated: January 18, 1995.
Philip R. Lee,
Assistant Secretary for Health.

    Approved: March 24, 1995.
Donna E. Shalala,
Secretary.

    Part 6 is added to chapter I of title 42 to read as 
follows: [[Page 22532]] 

PART 6--FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND 
INDIVIDUALS

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.


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 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 of 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.

[FR Doc. 95-11217 Filed 5-5-95; 8:45 am]
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