I
107TH CONGRESS
1ST SESSION
H. R. 3317
To amend title XVIII of the Social Security Act to provide for coverage
under the Medicare Program of self-administered drugs that, when used
as a replacement for covered drugs, result in overall cost savings to
the program.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 16, 2001
Ms. BALDWIN (for herself, Ms. WOOLSEY, Mr. KLECZKA, Mr. BARRETT of
Wisconsin, Mr. MATSUI, Mr. FRANK, Mrs. MINK of Hawaii, Ms. LEE,
Ms. KILPATRICK, Ms. SCHAKOWSKY, Mr. HILLIARD, Mr. EVANS, Mrs.
MCCARTHY of New York, and Mr. ALLEN) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on Ways and Means, for a period to be subse-
quently 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 coverage under the Medicare Program of self-admin-
istered drugs that, when used as a replacement for cov-
ered drugs, result in overall cost savings to the program.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medicare Drug Cost
Savings Act of 2001’’.
SEC. 2. MEDICARE COVERAGE OF COST SAVING SELF-AD-
MINISTERED DRUGS USED AS A REPLACE-
MENT FOR COVERED DRUGS.
(a) COVERAGE.—Section 1861(s)(2) of the Social Se-
curity Act (42 U.S.C. 1395x(s)(2)), as amended by sec-
tions 102(a) and 105(a) of the Medicare, Medicaid, and
SCHIP Benefits Improvement and Protection Act of 2000
(114 Stat. 2763A–468, 471), as enacted into law by sec-
tion 1(a)(6) of Public Law 106–554, is amended—
(1) by striking ‘‘and’’ at the end of subpara-
graph (U);
(2) by striking the period at the end of sub-
paragraph (V) and inserting ‘‘; and’’; and
(3) by inserting after subparagraph (V) the fol-
lowing new subparagraph:
‘‘(W) a self-administered drug (which is ap-
proved by the Food and Drug Administration)
that—
‘‘(i) is a full replacement for a drug or
drug therapy which is otherwise covered under
this title; and
‘‘(ii) as a full replacement for such drug or
drug therapy, results in overall cost savings
under this title for the treatment of the condi-
tion for which such drug or drug therapy is pre-
scribed (as determined by the Secretary);’’.
(b) PROHIBITION ON MANDATED SUBSTITUTION FOR
INTRAVENOUS DRUGS.—A carrier (under section 1842 of
the Social Security Act (42 U.S.C. 1395u)), or fiscal inter-
mediary (under section 1816 of such Act (42 U.S.C.
1395h)), may not require the substitution of a self-admin-
istered drug (under section 1861(s)(2)(W) of the Social
Security Act, as added by subsection (a)) for an intra-
venously-administered drug or drug therapy if, in the
judgment of the physician of the individual diagnosed with
a condition for which the drug or drug therapy has been
prescribed, intravenous-administration of the drug or drug
therapy is more appropriate or effective to treat the indi-
vidual’s condition.
(c) GAO STUDY.—
(1) IN GENERAL.—The Comptroller General of
the United States shall conduct a study on the im-
plementation by the Secretary of Health and Human
Services of section 1861(s)(2)(W) of the Social Se-
curity Act, as added by subsection (a). Such study
shall include the identification or evaluation of the
following:
(A) The self-administered drugs that the
Secretary has determined are appropriate for
use as replacement drugs under that section.
(B) The replacement self-administered
drugs for which the Secretary has made pay-
ment under the medicare program under title
XVIII of the Social Security Act (42 U.S.C.
1395 et seq.).
(C) The amount of savings attributable to
the use of such replacement self-administered
drugs.
(D) Additional self-administered drugs
that the Comptroller General determines would
be appropriate for use under that section.
(E) Any impact on utilization and bene-
ficiary access to self-administered drugs under
the medicare program.
(2) REPORT TO CONGRESS.—Not later than one
year after the date of the enactment of this Act, the
Comptroller General shall submit to Congress a re-
port on the study conducted under paragraph (1),
and may include such recommendations as the
Comptroller General determines appropriate.
(d) EFFECTIVE DATE.—The amendments made by
subsection (a) apply to drugs furnished on or after the
date that is 90 days after the date of the enactment of
this Act.
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