[Congressional Bills 111th Congress]
[From the U.S. Government Printing Office]
[S. 75 Introduced in Senate (IS)]
111th CONGRESS
1st Session
S. 75
To amend title XVIII of the Social Security Act to require the use of
generic drugs under the Medicare part D prescription drug program when
available unless the brand name drug is determined to be medically
necessary.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 6, 2009
Mr. Kohl 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 require the use of
generic drugs under the Medicare part D prescription drug program when
available unless the brand name drug is determined to be medically
necessary.
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 ``Generics First Act of 2009''.
SEC. 2. REQUIRED USE OF GENERIC DRUGS UNDER THE MEDICARE PART D
PRESCRIPTION DRUG PROGRAM.
(a) In General.--Section 1860D-2(e)(2) of the Social Security Act
(42 U.S.C. 1395w-102(e)(2)) is amended by adding at the end the
following new subparagraph:
``(C) Non-generic drugs unless certain requirements
are met.--
``(i) In general.--Such term does not
include a drug that is a nongeneric drug
unless--
``(I) no generic drug has been
approved under the Federal Food, Drug,
and Cosmetic Act with respect to the
drug; or
``(II) the nongeneric drug is
determined to be medically necessary by
the individual prescribing the drug and
prior authorization for the drug is
obtained from the Secretary.
``(ii) Definitions.--In this subparagraph:
``(I) Generic drug.--The term
`generic drug' means a drug that is the
subject of an application approved
under subsection (b)(2) or (j) of
section 505 of the Federal Food, Drug,
and Cosmetic Act, for which the
Secretary has made a determination that
the drug is the therapeutic equivalent
of a listed drug under section
505(j)(7) of such Act.
``(II) Nongeneric drug.--The term
`nongeneric drug' means a drug that is
the subject of an application approved
under--
``(aa) section 505(b)(1) of
the Federal Food, Drug, and
Cosmetic Act; or
``(bb) section 505(b)(2) of
such Act and that has been
determined to be not
therapeutically equivalent to
any listed drug.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to drugs dispensed on or after the date of enactment of this Act.
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