I
106TH CONGRESS
1ST SESSION
H. R. 1388
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
APRIL 13, 1999
Mrs. JOHNSON of Connecticut (for herself, Mr. CARDIN, Mr. ENGLISH, Mr.
WAXMAN, Mrs. THURMAN, Mr. SALMON, Mr. TOWNS, Mrs. KELLY, Mr.
OBERSTAR, Mrs. MORELLA, Mr. MCNULTY, Mr. WELDON of Pennsyl-
vania, Mr. SHOWS, Mr. SANDERS, Mrs. MALONEY of New York, Mr.
FROST, Mr. FRANK of Massachusetts, Mr. MOORE, and Mr. GONZALEZ)
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 jurisdiction of the com-
mittee 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 Clin-
ical Trial Coverage Act of 1999’’.
SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION
PROJECT.
(a) ESTABLISHMENT.—Not later than January 1,
2000, 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-
ticipation 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-
(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 Se-
curity Act of covering routine patient care costs for 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, 2004, 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
Medicare Program if coverage of routine patient
care costs in an approved clinical trial program were
extended 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 December 31, 2004.
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