[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 821 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 821

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 SENATE OF THE UNITED STATES

               April 22 (legislative day, April 19), 1993

Mr. Rockefeller introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Cancer Coverage Improvement 
Act of 1993''.

SEC. 2. UNIFORM MEDICARE COVERAGE OF ANTICANCER DRUGS.

    (a) In General.--Section 1861(t) of the Social Security Act (42 
U.S.C. 1395x(t)) is amended--
            (1) by inserting ``(1)'' after ``(t)'';
            (2) by striking ``(m)(5) of this section'' and inserting 
        ``(m)(5) and paragraph (2)''; and
            (3) by adding at the end thereof the following new 
        paragraph:
    ``(2)(A) For purposes of paragraph (1) the term `drugs' includes 
any drugs or biologics approved by the Food and Drug Administration 
used in an anticancer chemotherapeutic regimen for a medically accepted 
indication as described in subparagraph (B).
    ``(B) The term `medically accepted indication' means any use of a 
drug or biologic included under paragraph (1) if such use--
            ``(i) is included (or approved for inclusion) in one or 
        more of the following compendia: the American Hospital 
        Formulary Service-Drug Information, the American Medical 
        Association Drug Evaluations and the United States 
        Pharmacopoeia-Drug Information; or
            ``(ii) is supported by peer reviewed medical literature 
        appearing in publications which have been specifically approved 
        for purposes of this paragraph by the Secretary.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to items furnished on or after the first day of the 
first month that begins after the date of the enactment of this Act.

SEC. 3. COVERAGE OF CERTAIN SELF-ADMINISTERED ANTICANCER DRUGS.

    (a) In General.--Section 1861(s)(2) of the Social Security Act (42 
U.S.C. 1395(s)(2)) is amended--
            (1) by striking ``and'' at the end of subparagraph (O);
            (2) by adding ``and'' at the end of subparagraph (P); and
            (3) by adding at the end the following new subparagraph:
            ``(Q) an oral drug (which is approved by the Food and Drug 
        Administration) prescribed for use as an anticancer 
        chemotherapeutic agent for a given indication, and containing 
        an active ingredient (or ingredients) which is the same 
        indication and active ingredient (or ingredients) as that for a 
        drug which the carrier determines would be covered pursuant to 
        subparagraph (A) or (B);''.
    (b) Effective Date.--The amendments made by this section shall 
apply to items furnished on or after January 1, 1994.

SEC. 4. STUDY OF MEDICARE COVERAGE OF PATIENT CARE COSTS ASSOCIATED 
              WITH CLINICAL TRIALS OF NEW CANCER THERAPIES.

    (a) Study.--The Secretary of Health and Human Services shall 
conduct a study of the effects of expressly covering the patient care 
costs for medicare beneficiaries enrolled in clinical trials of new 
cancer therapies, where the protocol for the trial has been approved by 
the National Cancer Institute or meets similar scientific and ethical 
standards, including approval by an Institutional Review Board. The 
study shall include--
            (1) an estimate of the cost of such coverage, taking into 
        account the extent to which medicare currently pays for such 
        patient care costs in practice;
            (2) an assessment of the extent to which such clinical 
        trials represent the best available treatment for the patients 
        involved and of the effects of participation in the trials on 
        the health of such patients;
            (3) an assessment of whether progress in developing new 
        anticancer therapies would be assisted by medicare coverage of 
        such patient care costs; and
            (4) an evaluation of whether there should be special 
        criteria for the admission of medicare beneficiaries (on 
        account of their age or physical condition) to clinical trials 
        for which medicare would pay the patient care costs.
    (b) Report.--The Secretary of Health and Human Services shall 
submit a report on the study required by subsection (a), including 
recommendations as to the coverage of patient care costs of medicare 
beneficiaries enrolled in clinical trials of new cancer therapies, to 
the Committee on Finance of the Senate and the Committee on Ways and 
Means and the Committee on Energy and Commerce of the House of 
Representatives, not later than 2 years after the date of enactment of 
this Act.

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