Bill Details
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AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would change Medicare Part D rules so that certain prescription drugs would not have to be included in the drug manufacturer discount program. In simple terms, it creates an exception for some orally taken medicines that were first approved as brand-name drugs but later allowed to be treated as non-brand drugs under Medicaid rules. The goal appears to be to help keep access to these drugs available under Medicare while reducing the extra discount requirements for the manufacturers of those specific medicines.
- It applies only to certain drugs taken by mouth.
- The drug must have been approved through a new drug application by the Food and Drug Administration.
- The drug must also have received a special, limited exception from the Centers for Medicare & Medicaid Services allowing it to be reclassified as a non-innovator multiple source drug under the Medicaid drug rebate program.
- Those drugs would be excluded from the Medicare Part D manufacturer discount program, meaning manufacturers would not have to provide the usual discounts for them under that program.
Official Summaries
Ensuring Access to Essential Drugs Act
This bill exempts certain brand-name drugs from the Medicare Part D Manufacturer Discount Program. Under the program, drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible under the Medicare prescription drug benefit.
Specifically, the bill exempts from the program orally administered, brand-name drugs that are considered generics for purposes of the Medicaid Drug Rebate Program (per an exception granted by the Centers for Medicare & Medicaid Services).
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1922 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1922
To amend title XVIII of the Social Security Act to exempt certain drugs
from the part D manufacturer discount program under the Medicare
program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 6, 2025
Mr. Garbarino (for himself, Mrs. Harshbarger, and Mr. Suozzi)
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 subsequently 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 exempt certain drugs
from the part D manufacturer discount program under the Medicare
program.
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 ``Ensuring Access to Essential Drugs
Act''.
SEC. 2. EXEMPTING CERTAIN DRUGS FROM THE PART D MANUFACTURER DISCOUNT
PROGRAM UNDER THE MEDICARE PROGRAM.
Section 1860D-14C(g)(2) of the Social Security Act (42 U.S.C.
1395w-114c(g)(2)) is amended--
(1) in subparagraph (A), by striking ``and'' at the end;
(2) in subparagraph (B), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(C) does not include an orally administered
drug--
``(i) for which a new drug application was
approved under section 505 of the Federal Food,
Drug, and Cosmetic Act; and
``(ii) that has been granted a narrow
exception permitting reclassification as a
noninnovator multiple source drug under the
Medicaid drug rebate program by the Centers for
Medicare & Medicaid Services.''.
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