[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]
BILLING CODE 4160-15-M
