Bill Details
View committees (1)
AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would change how long certain prescription drugs must wait before they can be chosen for Medicare price negotiations. Right now, small-molecule drugs and biologic drugs are treated differently under the negotiation program. This bill would keep the current 7-year waiting period for small-molecule drugs for a short time, but starting in 2028 it would require the same 11-year wait that applies to biologic drugs. In simple terms, the bill gives drug makers more time before some medicines can be included in Medicare’s drug price negotiations.
- For initial price years in 2026 and 2027, small-molecule drugs would still need to wait at least 7 years after approval before they can be selected.
- Starting with initial price year 2028, and for every year after that, the waiting period would become 11 years after approval.
- The goal is to make the rules for small-molecule drugs match the rules already used for biologic drugs.
- The bill is part of the Medicare Drug Price Negotiation Program, which is meant to help set lower prices for certain drugs used by Medicare patients.
Official Summaries
Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025
This bill lengthens the amount of time for which drug products must have market approval in order for the products to qualify for negotiation under the Medicare Drug Price Negotiation Program.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation.
The bill modifies these provisions so as to require drug products to also have had at least 11 years of market approval in order to qualify for negotiation beginning in 2028.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 832 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 832
To amend title XI of the Social Security Act to equalize the
negotiation period between small-molecule and biologic candidates under
the Drug Price Negotiation Program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 4, 2025
Mr. Tillis (for himself, Mr. Budd, Mrs. Blackburn, Mr. Daines, and Mr.
Lankford) introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to equalize the
negotiation period between small-molecule and biologic candidates under
the Drug Price Negotiation 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 Pathways to Innovative
Cures Act of 2025'' or the ``EPIC Act of 2025''.
SEC. 2. EQUALIZING THE NEGOTIATION PERIOD BETWEEN SMALL-MOLECULE AND
BIOLOGIC CANDIDATES UNDER THE DRUG PRICE NEGOTIATION
PROGRAM.
Section 1192(e)(1)(A)(ii) of the Social Security Act (42 U.S.C.
1320f-1(e)(1)(A)(ii)) is amended--
(1) by striking ``year, at least 7'' and inserting ``year--
``(I) for initial price
applicability years 2026 and 2027, at
least 7''; and
(2) by adding at the end the following:
``(II) for initial price
applicability year 2028 and each
subsequent initial price applicability
year, at least 11 years will have
elapsed since the date of such
approval; and''.
<all>