I
105TH CONGRESS
2D SESSION
H. R. 3283
To amend title XVIII of the Social Security Act to provide for Medicare
reimbursement of routine patient care costs for individuals participating
in federally approved clinical trials and to require a report on costs
of requiring coverage of these costs under group health plans and health
insurance coverage.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 26, 1998
Mr. BENTSEN introduced the following bill; which was referred to the Commit-
tee on Ways and Means, and in addition to the Committee on Commerce,
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 amend title XVIII of the Social Security Act to provide
for Medicare reimbursement of routine patient care costs
for individuals participating in federally approved clinical
trials and to require a report on costs of requiring cov-
erage of these costs under group health plans and health
insurance coverage.
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 ‘‘Medicare Clinical Trial
Coverage Act of 1998’’.
SEC. 2. MEDICARE REIMBURSEMENT FOR INDIVIDUALS
PARTICIPATING IN CLINICAL TRIALS.
(a) IN GENERAL.—Section 1862 of the Social Secu-
rity Act (42 U.S.C. 1395y) is amended—
(1) in subsection (a)(1)—
(A) by striking ‘‘and’’ at the end of sub-
paragraph (H);
(B) by striking the semicolon at the end of
subparagraph (I) and inserting ‘‘, and’’; and
(C) by adding at the end the following new
subparagraph:
‘‘(J) in the case of expenses incurred in connec-
tion with any phase of a Federally approved clinical
trial (as defined in subsection (h)(1)), unless such
expenses are for routine patient care costs (as de-
fined in subsection (h)(2));’’; and
(2) by inserting after subsection (g) the follow-
ing new subsection:
‘‘(h)(1) For purposes of subsection (a)(1)(J), the
term ‘Federally approved clinical trial’ means a clinical
trial which is approved by any of the following:
‘‘(A) The Secretary.
‘‘(B) The Director of the the National Insti-
tutes of Health.
‘‘(C) The Commissioner of the Food and Drug
Administration.
‘‘(D) The Secretary of Veterans Affairs.
‘‘(E) The Secretary of Defense.
‘‘(F) The Secretary of Energy.
‘‘(G) A nongovernmental research entity (as de-
fined in the guidelines of the National Institutes of
Health) or a peer-review and approved research pro-
gram (as defined by the Secretary).
‘‘(2)(A) Subject to subparagraph (B), for purposes
of subsection (a)(1)(J), the term ‘routine patient care
costs’ includes the costs associated with the provision of
items and services that—
‘‘(i) would otherwise be covered under this title
if such items and services were not provided in con-
nection with a Federally approved clinical trial; and
‘‘(ii) are furnished according to the design of a
Federally approved clinical trial.
‘‘(B) Such term does not include the costs associated
with the provision of—
‘‘(i) an investigational drug or device, unless
the Secretary has authorized the manufacturer of
such drug or device to charge for such drug or de-
vice; or
‘‘(ii) any item or service supplied without
charge by the sponsor of the Federally approved
clinical trial.’’.
(b) 
ASSURING
COVERAGE
UNDER
MEDICARE+CHOICE PLANS.—Section 1852(d)(2) of such
Act (42 U.S.C. 1395w–22(d)(2)) is amended—
(1) by striking ‘‘and’’ at the end of subpara-
graph (D);
(2) by striking the period at the end of sub-
paragraph (E) and inserting ‘‘; and’’; and
(3) by adding at the end the following new sub-
paragraph:
‘‘(F) coverage is provided under the plan
for routine patient care costs of Federally ap-
proved clinical trials (as such terms are defined
in section 1862(h)).’’.
(c) EFFECTIVE DATE.—The amendments made by
this section apply to items and services furnished on or
after January 1, 1999.
SEC. 3. REPORT ON COSTS OF COVERAGE OF BENEFITS
FOR 
FEDERALLY 
APPROVED 
CLINICAL
TRIALS UNDER GROUP HEALTH PLANS AND
HEALTH INSURANCE COVERAGE.
The Secretaries of Health and Human Services and
Labor shall jointly prepare and submit to Congress a re-
port on the costs associated with requiring that group
health plans and health insurance coverage do not deny
payment of routine patient care costs for services fur-
nished in connection with Federally approved clinical trials
(as those terms are defined in section 1862(h) of the So-
cial Security Act).
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