CMS has proposed including select Medicare Part B drugs in the third round of its drug price negotiation program, according to draft guidance released May 12.
The agency said the proposal is designed to enhance transparency, focus on high-expenditure drugs and ensure that efforts to establish fair pricing do not stifle pharmaceutical innovation.
Five things for payers to know:
1. The guidance proposes including some drugs or biological products payable under Medicare Part B that don’t have generic or biosimilar competition.
2. CMS also outlined its process for drug price renegotiation in the draft guidance. The agency may renegotiate prices for 2028 for drugs originally negotiated in 2026 or 2027 if there is a key change, such as a new approval used for the drug or shift in market exclusivity. Such changes could trigger a review to adjust the drug’s price based on updated data. If renegotiated, the new price would apply to both Part B and Part D, as relevant.
3. The agency clarified how drugmakers must provide negotiated prices in 2026 and 2027. These policies will extend to drugs covered under Part D to 2028.
4. The first 10 negotiated drug prices are scheduled to go into effect Jan. 1, 2026. CMS will announce the next group of medications eligible for the third round of price negotiations by Feb. 1, 2026, with negotiated prices set to take effect in 2028. Any drugs selected for the first round of renegotiations will also be announced at this time.
5. The agency is seeking comments on the draft guidance through June 26.
View the full draft guidance here.
