II

104TH CONGRESS

2D SESSION S. 1963

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 SENATE OF THE UNITED STATES

JULY 17, 1996

Mr. ROCKEFELLER (for himself and Mr. MACK) introduced the following bill;

which was read twice and referred to the Committee on Finance

A BILL

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Medicare Cancer Clini5 cal Trial Coverage Act of 1996’’.
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1 SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION

2 PROJECT.

3 (a) ESTABLISHMENT.—Not later than January 1,

4 1997, the Secretary of Health and Human Services (in

5 this Act referred to as the ‘‘Secretary’’) shall establish a

6 demonstration project which provides for payment under

7 the medicare program under title XVIII of the Social Se8 curity Act (42 U.S.C. 1395 et seq.) of routine patient care

9 costs—

10 (1) which are provided to an individual diag11 nosed with cancer and enrolled in the medicare pro12 gram under such title as part of the individual’s par13 ticipation in an approved clinical trial program; and

14 (2) which are not otherwise eligible for payment

15 under such title for individuals who are entitled to

16 benefits under such title.

17 (b) APPLICATION.—The beneficiary cost sharing pro18 visions under the medicare program, such as deductibles,

19 coinsurance, and copayment amounts, shall apply to any

20 individual participating in a demonstration project con21 ducted under this Act.

22 (c) APPROVED CLINICAL TRIAL PROGRAM.—For

23 purposes of this Act, the term ‘‘approved clinical trial pro24 gram’’ means a clinical trial program which is approved

25 by—

26 (1) the National Institutes of Health;
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1 (2) a National Institutes of Health cooperative

2 group or a National Institutes of Health center;

3 (3) the Food and Drug Administration (in the

4 form of an investigational new drug or device exemp5 tion);

6 (4) the Department of Veterans Affairs;

7 (5) the Department of Defense; or

8 (6) a qualified nongovernmental research entity

9 identified in the guidelines issued by the National

10 Institutes of Health for center support grants.

11 (d) ROUTINE PATIENT CARE COSTS.—

12 (1) IN GENERAL.—For purposes of this Act,

13 ‘‘routine patient care costs’’ shall include the costs

14 associated with the provision of items and services

15 that—

16 (A) would otherwise be covered under the

17 medicare program if such items and services

18 were not provided in connection with an ap19 proved clinical trial program; and

20 (B) are furnished according to the design

21 of an approved clinical trial program.

22 (2) EXCLUSION.—For purposes of this Act,

23 ‘‘routine patient care costs’’ shall not include the

24 costs associated with the provision of—
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1 (A) an investigational drug or device, un2 less the Secretary has authorized the manufac3 turer of such drug or device to charge for such

4 drug or device; or

5 (B) any item or service supplied without

6 charge by the sponsor of the approved clinical

7 trial program.

8 SEC. 3. STUDY, REPORT, AND TERMINATION.

9 (a) STUDY.—The Secretary shall study the impact on

10 the medicare program under title XVIII of the Social Se11 curity Act of covering routine patient care costs for indi12 viduals with a diagnosis of cancer and other diagnoses,

13 who are entitled to benefits under such title and who are

14 enrolled in an approved clinical trial program.

15 (b) REPORT TO CONGRESS.—Not later than January

16 1, 2001, the Secretary shall submit a report to Congress

17 that contains a statement regarding—

18 (1) any incremental cost to the medicare pro19 gram under title XVIII of the Social Security Act

20 resulting from the provisions of this Act; and

21 (2) a projection of expenditures under the medi22 care program if coverage of routine patient care

23 costs in an approved clinical trial program were ex24 tended to individuals entitled to benefits under the
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1 medicare program who have a diagnosis other than

2 cancer.

3 (c) TERMINATION.—The provisions of this Act shall

4 not apply after June 30, 2001.

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