[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1787 Introduced in House (IH)]
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.
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 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 approved by the Food and Drug Administration which is included
under paragraph (1), which for a given condition--
``(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. ORAL CANCER DRUGS.
(a) Coverage of Certain Self-Administered Anticancer Drugs.--
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 a drug
which the carrier determines would be covered pursuant to
subparagraph (A) or (B) if the drug could not be self-
administered;''.
(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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