I
104TH CONGRESS
2D SESSION
H. R. 3959
To establish a demonstration project to study and provide coverage of routine
patient care costs for Medicare beneficiaries with cancer who are enrolled
in an approved clinical trial program.
IN THE HOUSE OF REPRESENTATIVES
AUGUST 2, 1996
Mrs. JOHNSON of Connecticut introduced the following bill; which was referred
to the Committee 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 juris-
diction of the committee concerned
A BILL
To establish a demonstration project to study and provide
coverage of routine patient care costs for Medicare bene-
ficiaries with cancer who are enrolled in an approved
clinical trial program.
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 Cancer Clini-
cal Trial Program Coverage Act of 1996’’.
SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION
PROJECT.
(a) ESTABLISHMENT.—Not later than January 1,
1997, the Secretary of Health and Human Services (in
this Act referred to as the ‘‘Secretary’’) shall establish a
demonstration project which provides for payment under
the Medicare Program under title XVIII of the Social Se-
curity Act (42 U.S.C. 1395 et seq.) of routine patient care
costs—
(1) which are provided to an individual diag-
nosed with cancer and enrolled in the Medicare Pro-
gram under such title as part of the individual’s par-
ticipating in an approved clinical trial program; and
(2) which are not otherwise eligible for payment
under such title for individuals who are entitled to
benefits under such title.
(b) APPLICATION.—The beneficiary cost sharing pro-
visions under the Medicare Program, such as deductibles,
coinsurance, and copayment amounts, shall apply to any
individual participating in a demonstration project con-
ducted under this Act.
(c) APPROVED CLINICAL TRIAL PROGRAM.—For
purposes of this Act, the term ‘‘approved clinical trial pro-
gram’’ means a clinical trial program which is approved
by—
(1) the National Institutes of Health;
(2) a National Institutes of Health cooperative
group or a National Institutes of Health center;
(3) the Food and Drug Administration (in the
form of an investigational new drug or device exemp-
tion);
(4) the Department of Veterans Affairs;
(5) the Department of Defense; or
(6) a qualified nongovernmental research entity
identified in the guidelines issued by the National
Institutes of Health for center support grants.
(d) ROUTINE PATIENT CARE COSTS.—
(1) IN GENERAL.—For purposes of this Act,
‘‘routine patient care costs’’ shall include the costs
associated with the provision of items and services
that—
(A) would otherwise be covered under the
Medicare Program if such items and services
were not provided in connection with an ap-
proved clinical trial program; and
(B) are furnished according to the design
of an approved clinical trial program.
(2) EXCLUSION.—For purposes of this Act,
‘‘routine patient care costs’’ shall not include the
costs associated with the provision of—
(A) an investigational drug or device, un-
less the Secretary has authorized the manufac-
turer of such drug or device to charge for such
drug or device; or
(B) any item or service supplied without
charge by the sponsor of the approved clinical
trial program.
SEC. 3. STUDY, REPORT, AND TERMINATION.
(A) STUDY.—The Secretary shall study the impact
on the Medicare Program under title XVIII of the Social
Security Act of covering routine patient care costs of indi-
viduals with a diagnosis of cancer and other diagnoses,
who are entitled to benefits under such title and who are
enrolled in an approved clinical trial program.
(b) REPORT TO CONGRESS.—Not later than January
1, 2001, the Secretary shall submit a report to Congress
that contains a statement regarding—
(1) any incremental cost to the Medicare Pro-
gram under title XVIII of the Social Security Act
resulting from the provisions of this Act; and
(2) a projection of expenditures under the Med-
icare Program if coverage of routine patient care
costs in an approved clinical trial program were ex-
tended to individuals entitled to benefits under the
Medicare Program who have a diagnosis other than
cancer.
(c) TERMINATION.—The provisions of this Act shall
not apply after June 30, 2001.
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