HR 1492
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.
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- Passed House
- Passed Senate
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Bill overview
This bill changes the rules for the Medicare Drug Price Negotiation Program by requiring drugs to have been on the market for 11 years, rather than 7 years, before they can be subject to negotiation. Currently, biologic drugs had a longer market approval period (11 years) than small-molecule drugs (7 years). This legislation aims to equalize the negotiation period for both types of drugs, ensuring that biologics are treated the same as small-molecule drugs when it comes to price negotiation under Medicare.
Key provisions
- Requires small-molecule drugs to have a 11-year market approval period to be eligible for negotiation.
- Requires biologic drugs to have a 11-year market approval period to be eligible for negotiation.
- Equalizes the negotiation period between small-molecule and biologic drugs.
- Amends Section 1192(e)(1)(A)(ii) of the Social Security Act.
Who is affected
- Pharmaceutical companies
- Medicare beneficiaries
- The Centers for Medicare & Medicaid Services
- Drug manufacturers
- The healthcare industry
Notable changes
- Extends the market approval period required for drug negotiation retroactively.
- Aligns the negotiation period for small-molecule and biologic drugs.
Fiscal impact
The bill may impact Medicare spending by altering the drugs subject to negotiation and their prices.
Sponsors
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119th CONGRESS — 1st Session
H. R. 1492
IN THE HOUSE OF REPRESENTATIVES
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.
7 yearsand inserting
11 years.
The amendment made by subsection (a) shall take effect as if included in the enactment of Public Law 117–169.