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 Pennsylvania, 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 committee concerned

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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Medicare Cancer Clin3 ical Trial Coverage Act of 1999’’.

4 SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION

5 PROJECT.

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

7 2000, the Secretary of Health and Human Services (in

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

9 demonstration project which provides for payment under

10 the Medicare Program under title XVIII of the Social Se11 curity Act (42 U.S.C. 1395 et seq.) of routine patient care

12 costs—

13 (1) which are provided to an individual diag14 nosed with cancer and enrolled in the medicare pro15 gram under such title as part of the individual’s par16 ticipation in an approved clinical trial program; and

17 (2) which are not otherwise eligible for payment

18 under such title for individuals who are entitled to

19 benefits under such title.

20 (b) APPLICATION.—The beneficiary cost sharing pro21 visions under the Medicare Program, such as deductibles,

22 coinsurance, and copayment amounts, shall apply to any

23 individual participating in a demonstration project con24 ducted under this Act.

25 (c) APPROVED CLINICAL TRIAL PROGRAM.—For

26 purposes of this Act, the term ‘‘approved clinical trial pro-
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1 gram’’ means a clinical trial program which is approved

2 by—

3 (1) the National Institutes of Health;

4 (2) a National Institutes of Health cooperative

5 group or a National Institutes of Health center;

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

7 form of an investigational new drug or device exemp8 tion);

9 (4) the Department of Veterans Affairs;

10 (5) the Department of Defense; or

11 (6) a qualified nongovernmental research entity

12 identified in the guidelines issued by the National

13 Institutes of Health for center support grants.

14 (d) ROUTINE PATIENT CARE COSTS.—

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

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

17 associated with the provision of items and services

18 that—

19 (A) would otherwise be covered under the

20 Medicare Program if such items and services

21 were not provided in connection with an ap22 proved clinical trial program; and

23 (B) are furnished according to the design

24 of an approved clinical trial program.
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1 (2) EXCLUSION.—For purposes of this Act,

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

3 costs associated with the provision of—

4 (A) an investigational drug or device, un5 less the Secretary has authorized the manufac6 turer of such drug or device to charge for such

7 drug or device; or

8 (B) any item or service supplied without

9 charge by the sponsor of the approved clinical

10 trial program.

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

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

13 the Medicare Program under title XVIII of the Social Se14 curity Act of covering routine patient care costs for indi15 viduals with a diagnosis of cancer and other diagnoses,

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

17 enrolled in an approved clinical trial program.

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

19 1, 2004, the Secretary shall submit a report to Congress

20 that contains a statement regarding—

21 (1) any incremental cost to the Medicare Pro22 gram under title XVIII of the Social Security Act

23 resulting from the provisions of this Act; and

24 (2) a projection of expenditures under the

25 Medicare Program if coverage of routine patient
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1 care costs in an approved clinical trial program were

2 extended to individuals entitled to benefits under the

3 Medicare Program who have a diagnosis other than

4 cancer.

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

6 not apply after December 31, 2004.

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