Sponsors (8)
The bill preserves some near-term negotiation benefits for certain drugs in 2026–2027 and shifts negotiation focus to older, better-studied medicines from 2028 onward, but it delays negotiated price relief for many drugs during years 8–11 post-approval — likely raising costs for patients and Medicare while reducing HHS's bargaining leverage.
Medicare beneficiaries and patients with chronic conditions keep access to earlier price negotiation for some drugs in 2026–2027, allowing Medicare to seek lower prices for medicines sooner than under a full 11-year delay.
Taxpayers and Medicare beneficiaries may see stronger, more evidence-based negotiation outcomes beginning in 2028 because focusing negotiations on drugs at least 11 years post-approval targets longer-established medicines with more real-world data.
Patients who rely on newer (but not brand-new) drugs — including many with chronic conditions — will face delayed price negotiation starting in 2028 because drugs will be excluded from negotiation until 11 years after approval.
Medicare beneficiaries and taxpayers are likely to face higher out-of-pocket costs and increased Medicare spending in 2028 and beyond because fewer drugs will qualify for negotiated prices during their commercial lifecycle.
The Department of Health and Human Services (HHS) will have reduced bargaining leverage by excluding drugs in years 8–11 after approval, which could slow downward pressure on drug list prices overall.
Based on analysis of 2 sections of legislative text.
Extends the minimum time since FDA approval a drug must have passed to be eligible for federal price negotiation: 7 years for 2026–27, 11 years for 2028 and after.
Official title: 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.
Introduced March 4, 2025 by Thomas Roland Tillis · Last progress March 4, 2025
Moves the earliest eligibility date for a prescription drug to enter the federal Drug Price Negotiation Program from 7 years after approval (for most years) to 11 years for initial price applicability year 2028 and later, while keeping a 7-year rule for the program’s first two application years (2026 and 2027). The change delays when many drugs can be selected for government negotiation, affecting which medicines may face price negotiations under the program going forward.