I

106TH CONGRESS

1ST SESSION H. R. 61

To amend title XVIII of the Social Security Act to provide for Medicare

reimbursement of routine patient care costs for individuals participating

in Federally approved clinical trials and to require a report on costs

of requiring coverage of these costs under group health plans and health

insurance coverage.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 6, 1999

Mr. BENTSEN (for himself, Mr. HALL of Texas, and Mr. SANDLIN) 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 amend title XVIII of the Social Security Act to provide

for Medicare reimbursement of routine patient care costs

for individuals participating in Federally approved clinical trials and to require a report on costs of requiring

coverage of these costs under group health plans and

health insurance coverage.

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 Clinical Trial

3 Coverage Act of 1999’’.

4 SEC. 2. MEDICARE REIMBURSEMENT FOR INDIVIDUALS

5 PARTICIPATING IN CLINICAL TRIALS.

6 (a) IN GENERAL.—Section 1862 of the Social Secu7 rity Act (42 U.S.C. 1395y) is amended—

8 (1) in subsection (a)(1)—

9 (A) by striking ‘‘and’’ at the end of sub10 paragraph (H);

11 (B) by striking the semicolon at the end of

12 subparagraph (I) and inserting ‘‘, and’’; and

13 (C) by adding at the end the following new

14 subparagraph:

15 ‘‘(J) in the case of expenses incurred in connec16 tion with any phase of a Federally approved clinical

17 trial (as defined in subsection (h)(1)), unless such

18 expenses are for routine patient care costs (as de19 fined in subsection (h)(2));’’; and

20 (2) by inserting after subsection (g) the follow21 ing new subsection:

22 ‘‘(h)(1) For purposes of subsection (a)(1)(J), the

23 term ‘Federally approved clinical trial’ means a clinical

24 trial which is approved by any of the following:

25 ‘‘(A) The Secretary.
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1 ‘‘(B) The Director of the the National Insti2 tutes of Health.

3 ‘‘(C) The Commissioner of the Food and Drug

4 Administration.

5 ‘‘(D) The Secretary of Veterans Affairs.

6 ‘‘(E) The Secretary of Defense.

7 ‘‘(F) The Secretary of Energy.

8 ‘‘(G) A nongovernmental research entity (as de9 fined in the guidelines of the National Institutes of

10 Health) or a peer-review and approved research pro11 gram (as defined by the Secretary).

12 ‘‘(2)(A) Subject to subparagraph (B), for purposes

13 of subsection (a)(1)(J), the term ‘routine patient care

14 costs’ includes the costs associated with the provision of

15 items and services that—

16 ‘‘(i) would otherwise be covered under this title

17 if such items and services were not provided in con18 nection with a Federally approved clinical trial; and

19 ‘‘(ii) are furnished according to the design of a

20 Federally approved clinical trial.

21 ‘‘(B) Such term does not include the costs associated

22 with the provision of—

23 ‘‘(i) an investigational drug or device, unless

24 the Secretary has authorized the manufacturer of
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1 such drug or device to charge for such drug or de2 vice; or

3 ‘‘(ii) any item or service supplied without

4 charge by the sponsor of the Federally approved

5 clinical trial.’’.

6 (b) ASSURING COVERAGE UNDER

7 MEDICARE+CHOICE PLANS.—Section 1852(d)(1) of such

8 Act (42 U.S.C. 1395w–22(d)(1)) is amended—

9 (1) by striking ‘‘and’’ at the end of subpara10 graph (D);

11 (2) by striking the period at the end of sub12 paragraph (E) and inserting ‘‘; and’’; and

13 (3) by adding at the end the following new sub14 paragraph:

15 ‘‘(F) coverage is provided under the plan

16 for routine patient care costs of Federally ap17 proved clinical trials (as such terms are defined

18 in section 1862(h)).’’.

19 (c) EFFECTIVE DATE.—The amendments made by

20 this section apply to items and services furnished on or

21 after January 1, 2000.
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1 SEC. 3. REPORT ON COSTS OF COVERAGE OF BENEFITS

2 FOR FEDERALLY APPROVED CLINICAL

3 TRIALS UNDER GROUP HEALTH PLANS AND

4 HEALTH INSURANCE COVERAGE.

5 The Secretaries of Health and Human Services and

6 Labor shall jointly prepare and submit to Congress a re7 port on the costs associated with requiring that group

8 health plans and health insurance coverage do not deny

9 payment of routine patient care costs for services fur10 nished in connection with Federally approved clinical trials

11 (as those terms are defined in section 1862(h) of the So12 cial Security Act).

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