I

104TH CONGRESS

2D SESSION H. R. 3958

To permit individuals to continue coverage under Federal health care programs of services while participating in approved clinical studies and

to require the Secretary of Health and Human Services to make publicly

available information on clinical trials.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 2, 1996

Mrs. JOHNSON of Connecticut introduced the following bill; which was referred

to the Committee on Commerce, and in addition to the Committees on

Ways and Means, National Security, Veterans’ Affairs, and Government

Reform and Oversight, for a period to be subsequently determined by the

Speaker, in each case for consideration of such provisions as fall within

the jurisdiction of the committee concerned

A BILL

To permit individuals to continue coverage under Federal

health care programs of services while participating in

approved clinical studies and to require the Secretary

of Health and Human Services to make publicly available

information on clinical trials.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Federal Coverage for

5 Clinical Trials Act of 1996’’.
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1 SEC. 2. COVERAGE UNDER CERTAIN FEDERAL HEALTH

2 CARE PROGRAMS FOR INDIVIDUALS PARTICI3 PATING IN APPROVED CLINICAL STUDIES.

4 (a) PERMITTING PARTICIPATION IN APPROVED CLIN5 ICAL STUDIES.—A Federal health care program may not

6 deny (or limit or impose additional conditions on) coverage

7 of items and services furnished to an enrollee if—

8 (1) the enrollee is participating in an approved

9 clinical study,

10 (2) the items and services are furnished accord11 ing to the design of the study or to treat conditions

12 resulting from participation in the study, and

13 (3) the items and services would otherwise be

14 covered under the program except for the fact that

15 they are provided in connection with participation in

16 such a study.

17 Such a program may not discriminate against an enrollee

18 on the basis of the enrollee’s participation in such a study.

19 (b) CONSTRUCTION.—Nothing in subsection (a) shall

20 be construed as requiring a Federal health care program

21 to provide for payment for items and services normally

22 paid for as part of an approved clinical study, such as

23 the experimental therapy or drug itself.

24 (c) APPROVED CLINICAL STUDY DEFINED.—In this

25 Act, the term ‘‘approved clinical study’’ means—
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1 (1) a research study approved by the Secretary

2 of Health and Human Services, the Director of the

3 National Institutes of Health, the Commissioner of

4 the Food and Drug Administration, the Secretary of

5 Veterans Affairs, the Secretary of Defense, or a

6 qualified nongovernmental research entity (as de7 fined in guidelines of the National Institute of

8 Health), or

9 (2) a peer-reviewed and approved research pro10 gram, as defined by the Secretary of Health and

11 Human Services, conducted for the primary purpose

12 of determining whether or not a treatment is safe,

13 efficacious, or having any other characteristic of a

14 treatment which must be demonstrated in order for

15 the treatment to be medically necessary or appro16 priate.

17 (d) FEDERAL HEALTH CARE PROGRAM DEFINED.—

18 In this section, the term ‘‘Federal health care program’’

19 means the following:

20 (1) MEDICARE.—The medicare program under

21 title XVIII of the Social Security Act.

22 (2) FEHBP.—Health benefits plans offered

23 under the Federal Employees Health Benefit Plan

24 under chapter 89 of title 5, United States Code.
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1 (3) VA HEALTH CARE.—The veterans health

2 care program under chapter 17 of title 38, United

3 States Code.

4 (4) DOD-RELATED PROGRAMS.—The Civilian

5 Health and Medical Program of the Uniformed

6 Services (CHAMPUS), as defined in section 1072(4)

7 of title 10, United States Code.

8 (e) COVERAGE UNDER MEDICAID PROGRAM.—Noth9 ing in title XIX of the Social Security Act shall be con10 strued as preventing a State from receiving Federal finan11 cial participation with respect to medical assistance for

12 which coverage is otherwise required to be provided by a

13 Federal health care program under this section.

14 SEC. 3. MAKING PUBLICLY AVAILABLE INFORMATION ON

15 RESULTS OF APPROVED CLINICAL STUDIES.

16 The Secretary of Health and Human Services shall

17 make available to the public information about clinical in18 vestigations and results obtained from approved clinical

19 studies (as defined in section 2(c)).

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