Federally Supported Health Centers Assistance Act of 1992

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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