I
104TH CONGRESS
2D SESSION
H. R. 3958
To permit individuals to continue coverage under Federal health care pro-
grams 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.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Federal Coverage for
Clinical Trials Act of 1996’’.
SEC. 2. COVERAGE UNDER CERTAIN FEDERAL HEALTH
CARE PROGRAMS FOR INDIVIDUALS PARTICI-
PATING IN APPROVED CLINICAL STUDIES.
(a) PERMITTING PARTICIPATION IN APPROVED CLIN-
ICAL STUDIES.—A Federal health care program may not
deny (or limit or impose additional conditions on) coverage
of items and services furnished to an enrollee if—
(1) the enrollee is participating in an approved
clinical study,
(2) the items and services are furnished accord-
ing to the design of the study or to treat conditions
resulting from participation in the study, and
(3) the items and services would otherwise be
covered under the program except for the fact that
they are provided in connection with participation in
such a study.
Such a program may not discriminate against an enrollee
on the basis of the enrollee’s participation in such a study.
(b) CONSTRUCTION.—Nothing in subsection (a) shall
be construed as requiring a Federal health care program
to provide for payment for items and services normally
paid for as part of an approved clinical study, such as
the experimental therapy or drug itself.
(c) APPROVED CLINICAL STUDY DEFINED.—In this
Act, the term ‘‘approved clinical study’’ means—
(1) a research study approved by the Secretary
of Health and Human Services, the Director of the
National Institutes of Health, the Commissioner of
the Food and Drug Administration, the Secretary of
Veterans Affairs, the Secretary of Defense, or a
qualified nongovernmental research entity (as de-
fined in guidelines of the National Institute of
Health), or
(2) a peer-reviewed and approved research pro-
gram, as defined by the Secretary of Health and
Human Services, conducted for the primary purpose
of determining whether or not a treatment is safe,
efficacious, or having any other characteristic of a
treatment which must be demonstrated in order for
the treatment to be medically necessary or appro-
priate.
(d) FEDERAL HEALTH CARE PROGRAM DEFINED.—
In this section, the term ‘‘Federal health care program’’
means the following:
(1) MEDICARE.—The medicare program under
title XVIII of the Social Security Act.
(2) FEHBP.—Health benefits plans offered
under the Federal Employees Health Benefit Plan
under chapter 89 of title 5, United States Code.
(3) VA HEALTH
CARE.—The veterans health
care program under chapter 17 of title 38, United
States Code.
(4) DOD-RELATED
PROGRAMS.—The Civilian
Health and Medical Program of the Uniformed
Services (CHAMPUS), as defined in section 1072(4)
of title 10, United States Code.
(e) COVERAGE UNDER MEDICAID PROGRAM.—Noth-
ing in title XIX of the Social Security Act shall be con-
strued as preventing a State from receiving Federal finan-
cial participation with respect to medical assistance for
which coverage is otherwise required to be provided by a
Federal health care program under this section.
SEC. 3. MAKING PUBLICLY AVAILABLE INFORMATION ON
RESULTS OF APPROVED CLINICAL STUDIES.
The Secretary of Health and Human Services shall
make available to the public information about clinical in-
vestigations and results obtained from approved clinical
studies (as defined in section 2(c)).
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