[Federal Register Volume 59, Number 160 (Friday, August 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20361]
[[Page Unknown]]
[Federal Register: August 19, 1994]
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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: Notice of proposed rulemaking.
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SUMMARY: The Secretary of Health and Human Services (the
``Secretary''), in consultation with the Attorney General, proposes to
issue 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 proposed rule 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.
DATES: The public is invited to submit comments on this proposed rule
until September 19, 1994.
ADDRESSES: Comments should be submitted to:
Libby Merrill, Office of Program Policy and Development, Bureau of
Primary Health Care, 4350 East-West Highway, Rockville, Maryland
20857.
FOR FURTHER INFORMATION CONTACT:
Richard C. Bohrer, Director, Division of Community and Migrant
Health, Phone: (301) 594-4300.
SUPPLEMENTARY INFORMATION:
I. Introduction
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
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 proposed rule
implements certain provisions of Pub. L. 102-501.
II. Entities
An entity will be deemed to be an employee of the Public Health
Service pursuant to Pub. L. 102-501 only if HHS, in consultation with
the Attorney General, has determined, and has advised the entity, that
the entity--
(A) receives Federal funds under any of the following grant
programs:
(1) Section 329 of the Act, 42 U.S.C. 254b (relating to grants for
migrant health centers);
(2) Section 330 of the Act, 42 U.S.C. 254c (relating to grants for
community health centers);
(3) Section 340 of the Act, 42 U.S.C. 256 (relating to grants for
health services for the homeless); and
(4) Section 340A of the Act, 42 U.S.C. 256a (relating to grants for
health services for residents of public housing); and
(B) meets the following requirements:
(1) has implemented appropriate policies and procedures to reduce
the risk of malpractice and the risk of lawsuits arising out of any
health or health-related functions performed by the entity;
(2) has reviewed and verified the professional credentials,
references, claims history, fitness, progressional review organization
findings, and license status of its physicians and other licensed or
certified health care practitioners, and, where necessary, has obtained
the permission from these individuals to gain access to this
information;
(3) has no history of claims having been filed against the United
States as a result of the application of section 224 to the entity of
its officers, employees, of contractors as provided for under this
section, or, is such a history exists, has fully cooperated with the
Attorney General in defending against any such claims and either has
taken, or will take, any necessary corrective steps to assure against
such claims in the future; and
(4) has fully cooperated with the Attorney General in providing
information relating to an estimate described under section 224(k) of
the Act.
Proposed Sec. 6.5 provides that an entity will be deemed to be an
entity described in section 224(g) as of the effective date of the
notice which it receives from the Department of Health and Human
Services that it has been deemed to be an entity as described for
purposes of the Act. Each notice shall be effective only as to acts and
omissions occurring on and after the date specified in the notice and
prior to January 1, 1996, the statutory sunset date for this program.
(Proposed Sec. 6.6(a).)
In some cases, grantees contract with other entities (as opposed to
individual contractors--see section III below) for the provision of
health services. The typical situation is a subgrant or contract for
the provision of the full range of health services. For example, the
legislative history of Pub. L. 102-501 describes the case of a grantee
in the Los Angeles area which itself has no clinical staff, but which
contracts with three primary care clinics for the actual delivery of
services. If one (or more) of these clinics provides the full range of
services mandated under section 330 to its own medically undeserved
population, in accordance with other applicable requirements under
section 330, it would be eligible for a determination by the Secretary
that it too is a covered entity. (H.R. Rep. No. 102-823, Part 2, p. 7,
102d Cong. 2d Sess., Sept. 14, 1992.) Proposed Sec. 6.3(b) provides
that the Secretary will identify those contracting entities that will
be subject to coverage under section 224(g) in notices issued pursuant
to Sec. 6.5.
III. Covered Individuals
In addition to the entity itself, section 224(g) provides that
certain individuals may be covered under the FTCA. Officers and
employees are subject to coverage, as well as certain contractors.
Public Law 102-501 provides that an individual may be considered to
be a contractor of an entity described in Pub. L. 102-501 only if--
(A) the individual normally performs on average at least 32\1/2\
hours of service per week for the entity for the period of the
contract; or
(B) in the case of an individual who normally performs on average
less than 32\1/2\ hours of services per week for the entity for the
period of the contract and is a licensed or certified provider of
obstetrical services--
(1) the individual's medical malpractice liability insurance
coverage does not extend to services performed by the individual for
the entity under the contract; or
(2) the Secretary finds that patients to whom the entity furnishes
services will be deprived of obstetrical services if such individual is
not considered a contractor of the entity for purposes of paragraph
(1).
Coverage of individuals, whether employees of contractors, does not
extend to acts or omissions that are not related to the grant supported
activity. The covered entity itself (assuming it meets the statutory
requirements for FTCA coverage) will be covered for claims against it,
even if an individual health care practitioner is not covered in a
particular case. Thus, for example, if a contractor works fewer than
32\1/2\ hours and is not a provider of obstetrical services, the
contractor would not be covered for services related to the grant, but
the grantee itself would be covered.
IV. Covered Acts and Omissions
Proposed Sec. 6.6 provides elaboration on the scope of the
statutory protection for covered entities and individuals. Paragraph
(a) states the relevant dates of coverage. Paragraph (b) repeats the
provision of section 224(a) that limits coverage to claims for damage
for personal injury or death resulting from the performance of medical,
surgical, dental, or related functions. Paragraph (c) states that for
covered individuals, only acts or omissions within the scope of their
employment (or contract for services, in the case of covered
contractors) are covered. Thus, for example, ``moonlighting''
activities of a physician employed by a covered grantee would not be
covered.
Paragraph (d) of proposed Sec. 6.6 addresses the limitation that
only acts or omissions related to the grant-supported activity are
covered. The Department is aware that there has been some confusion
since the enactment of section 224(g) about the types of activities
that would be covered. In particular, there have been questions about
the issue of when coverage is available where individuals who are not
registered patients of the grantee are treated. This paragraph provides
clear standards for answering these questions. Coverage will be
available for the treatment of non-patients of the covered entities
only when the Secretary determines either 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
the entity, or (2) the provision of 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. Examples of situations within the scope of
proposed Sec. 6.6(d) are as follows:
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 subparagraph (1).
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 subparagraph (2).
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 subparagraph (3). Again,
however, it should be understood that this would not extend the scope
of coverage under Pub. L. 102-501 to ``moonlighting'' activities by
center health care practitioners.
This proposed 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 above. 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.
A determination or certification by the Attorney General is subject to
judicial review.
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 the significantly impact small businesses.
These proposed regulations provide information whereby health care
entities or individual scan determine when, and to what extent they are
likely to be protected for medical malpractice under the Federal Tort
Claims Act (FTCA). Therefore, the Secretary certifies that the proposed
regulations 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 proposed 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: May 9, 1994.
Philip R. Lee,
Assistant Secretary for Health.
Approved: June 16, 1994.
Donna E. Shalala,
Secretary.
Part 6 is added to Chapter I of Title 42 to read as follows:
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 January
1, 1996, 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 or 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.
[FR Doc. 94-20361 Filed 8-18-94; 8:45 am]
BILLING CODE 4160-15-M
