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103D CONGRESS

1ST SESSION H. R. 1787

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

coverage of anticancer drugs under the medicare program, and for other

purposes.

IN THE HOUSE OF REPRESENTATIVES

APRIL 21, 1993

Mr. LEVIN introduced the following bill; which was referred jointly to the

Committees on Ways and Means and Energy and Commerce

A BILL

To amend title XVIII of the Social Security Act to provide

for uniform coverage of anticancer drugs under the medicare program, and for other purposes.

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 Cov5 erage Improvement Act of 1993’’.

6 SEC. 2. UNIFORM MEDICARE COVERAGE OF ANTICANCER

7 DRUGS.

8 (a) IN GENERAL.—Section 1861(t) of the Social Se9 curity Act (42 U.S.C. 1395x(t)) is amended—
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1 (1) by inserting ‘‘(1)’’ after ‘‘(t)’’;

2 (2) by striking ‘‘(m)(5) of this section’’ and in3 serting ‘‘(m)(5) and paragraph (2)’’; and

4 (3) by adding at the end thereof the following

5 new paragraph:

6 ‘‘(2)(A) For purposes of paragraph (1) the term

7 ‘drugs’ includes any drugs or biologics used in an

8 anticancer chemotherapeutic regimen for a medically ac9 cepted indication (as described in subparagraph (B)).

10 ‘‘(B) The term ‘medically accepted indication’ means

11 any use of a drug approved by the Food and Drug Admin12 istration which is included under paragraph (1), which for

13 a given condition—

14 ‘‘(i) is included (or approved for inclusion) in

15 one or more of the following compendia: the Amer16 ican Hospital Formulary Service-Drug Information,

17 the American Medical Association Drug Evaluations,

18 and the United States Pharmacopoeia-Drug Infor19 mation; or

20 ‘‘(ii) is supported by peer reviewed medical lit21 erature appearing in publications which have been

22 specifically approved for purposes of this paragraph

23 by the Secretary.’’.

24 (b) EFFECTIVE DATE.—The amendments made by

25 subsection (a) shall apply with respect to items furnished
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1 on or after the first day of the first month that begins

2 after the date of the enactment of this Act.

3 SEC. 3. ORAL CANCER DRUGS.

4 (a) COVERAGE OF CERTAIN SELF-ADMINISTERED

5 ANTICANCER DRUGS.—Section 1861(s)(2) of the Social

6 Security Act (42 U.S.C. 1395(s)(2)) is amended—

7 (1) by striking ‘‘and’’ at the end of subpara8 graph (O);

9 (2) by adding ‘‘and’’ at the end of subpara10 graph (P); and

11 (3) by adding at the end the following new sub12 paragraph:

13 ‘‘(Q) an oral drug (which is approved by the

14 Food and Drug Administration) prescribed for use

15 as an anticancer chemotherapeutic agent for a given

16 indication, and containing an active ingredient (or

17 ingredients), which is the same indication and active

18 ingredient (or ingredients) as a drug which the car19 rier determines would be covered pursuant to sub20 paragraph (A) or (B) if the drug could not be self21 administered;’’.

22 (b) EFFECTIVE DATE.—The amendments made by

23 this section shall apply to items furnished on or after Jan24 uary 1, 1994.
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1 SEC. 4. STUDY OF MEDICARE COVERAGE OF PATIENT CARE

2 COSTS ASSOCIATED WITH CLINICAL TRIALS

3 OF NEW CANCER THERAPIES.

4 (a) STUDY.—The Secretary of Health and Human

5 Services shall conduct a study of the effects of expressly

6 covering the patient care costs for medicare beneficiaries

7 enrolled in clinical trials of new cancer therapies, where

8 the protocol for the trial has been approved by the Na9 tional Cancer Institute or meets similar scientific and ethi10 cal standards, including approval by an Institutional Re11 view Board. The study shall include—

12 (1) an estimate of the cost of such coverage,

13 taking into account the extent to which medicare

14 currently pays for such patient care costs in prac15 tice;

16 (2) an assessment of the extent to which such

17 clinical trials represent the best available treatment

18 for the patients involved and of the effects of partici19 pation in the trials on the health of such patients;

20 (3) an assessment of whether progress in devel21 oping new anticancer therapies would be assisted by

22 medicare coverage of such patient care costs; and

23 (4) an evaluation of whether there should be

24 special criteria for the admission of medicare bene25 ficiaries (on account of their age or physical condi-
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1 tion) to clinical trials for which medicare would pay

2 the patient care costs.

3 (b) REPORT.—The Secretary of Health and Human

4 Services shall submit a report on the study required by

5 subsection (a) (including recommendations as to the cov6 erage of patient care costs of medicare beneficiaries en7 rolled in clinical trials of new cancer therapies) to the

8 Committee on Finance of the Senate and the Committee

9 on Ways and Means and the Committee on Energy and

10 Commerce of the House of Representatives, not later than

11 2 years after the date of enactment of this Act.

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