CMS opens comment period on permanent Medicare drug-negotiation framework
The Centers for Medicare & Medicaid Services has opened a public-comment period on a proposed permanent framework for negotiating Medicare drug prices, setting out rules that would apply to high-cost, single-source drugs beginning with the program’s 2029 initial price applicability year.
CMS issued the proposed rule June 12, 2026. Comments are due Aug. 17, giving manufacturers, Medicare plans, providers and patients an opportunity to weigh in before the agency decides whether and how to finalize the framework.
The proposal is not a final regulation. Instead, it would establish the long-term structure for the Medicare Drug Price Negotiation Program, including how CMS would conduct initial negotiations and later renegotiations for qualifying drugs.
A framework for future negotiations
The proposed rule focuses on high-cost, single-source drugs. Its initial application would begin with the 2029 price-applicability year, placing the framework beyond Medicare’s first negotiated-price cycle and into the rules that would govern later rounds.
That distinction is important for Medicare beneficiaries and other stakeholders. CMS is not announcing a final price for a specific drug through this proposal. The rule would instead establish the process used to determine maximum fair prices for drugs selected in future negotiation cycles.
The proposal also addresses renegotiations. That would give CMS a continuing framework for reviewing negotiated drugs after an initial negotiation, rather than treating each future cycle as an entirely separate process.
Which medicines would ultimately be selected, and what prices would apply, would depend on later selection decisions and negotiations. CMS’s public description of the proposal does not quantify eventual savings from the 2029 framework.
First negotiated prices took effect in 2026
The proposed permanent framework comes as the program’s first negotiated prices are already in effect. CMS said maximum fair prices for the first 10 selected drugs took effect Jan. 1, 2026.
Those 10 drugs represent the program’s first negotiated-price cycle. The new proposal would govern later cycles, including the 2029 cycle identified in the rule, rather than change the fact that the first negotiated prices have already taken effect.
For people covered by Medicare, the practical significance of the proposal will depend on which drugs enter future negotiation cycles and how the final rules operate. The immediate public decision is whether to submit comments before the Aug. 17 deadline.
Separate guidance addresses 2028 implementation
CMS is also seeking input on a separate implementation issue before the proposed permanent framework would apply. On July 16, 2026, the agency issued draft manufacturer-effectuation guidance for negotiated prices that would apply in 2028.
The draft guidance addresses how manufacturers, dispensing entities and Part B providers would implement maximum fair prices for selected Part B and Part D drugs in 2028. It is focused on putting negotiated prices into practice, while the proposed rule concerns the broader long-term structure for negotiations and renegotiations.
Comments on the 2028 draft guidance are due Sept. 18, 2026. That is a separate deadline from Aug. 17, the closing date for comments on the proposed permanent framework.
The two proceedings therefore present different questions for interested parties. The proposed rule asks for feedback on the structure CMS would use for future negotiations beginning in 2029. The draft guidance asks how participants would carry out negotiated pricing for selected drugs in 2028.
After the Aug. 17 comment deadline, CMS will have to consider public input before establishing any final framework for the 2029 price-applicability year. Until then, the permanent rules remain proposed, while the 2028 implementation guidance remains a draft.
Sources
- CMS Proposed Rule Locks in Lower Prices and Fosters Innovation for the Medicare Drug Price Negotiation Program, Centers for Medicare & Medicaid Services
- Medicare Drug Price Negotiation Program: Regulations, Guidance and Policy Documents, Centers for Medicare & Medicaid Services
- Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Negotiation, Centers for Medicare & Medicaid Services
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