SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION
PROJECT.
(a) ESTABLISHMENT.—Not later than January 1,
1998, 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-
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 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, 2002, 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 December 31, 2002.
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