Federal Medicare Payment Policy Comment Opportunity — Not a Grant
The Centers for Medicare & Medicaid Services (CMS) is accepting public comments on its Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fair Price in 2028. The guidance addresses how manufacturers must make the negotiated Maximum Fair Price (MFP) available in 2028 for selected drugs payable under Medicare Part B and/or covered under Part D. This is a federal policy-comment process, not a grant, procurement, or applicant funding program.
Comment Deadline
September 18, 2026 at 11:59 p.m. Pacific Time (PT).
Submission Method
CMS instructs interested parties to submit comments by email to IRARebateandNegotiation@cms.hhs.gov with the subject line Medicare Drug Price Negotiation Program Draft Guidance.
Who May Be Affected
The draft guidance addresses procedures affecting primary drug manufacturers, Medicare Part D plan sponsors and Medicare Advantage organizations, pharmacies and other dispensing entities, and hospitals, physicians, suppliers, and other Part B providers that furnish or administer selected drugs.
Key Policy Areas
- Use of the Medicare Transaction Facilitator Data Module and Payment Module.
- Part B claims and encounter-data workflows for determining MFP eligibility.
- A proposed 14-day prompt MFP payment window.
- Part B provider enrollment considerations for the MTF Data Module.
- Claim-level data elements, including HCPCS and potential NDC-11 information.
- Approaches for standardized default refund amounts when actual acquisition cost is difficult to establish.
Eligibility, Funding, and Match
There is no award amount, applicant cap, grant eligibility class, or non-Federal match requirement because this is a public-comment opportunity. CMS encourages interested parties to comment on the draft policies before final guidance is issued.
Atlas Relevance
This is material Medicare reimbursement and implementation intelligence for hospitals, physicians, Medicare Advantage organizations, pharmacies, manufacturers, and other providers or suppliers affected by selected Part B or Part D drugs. Because the deadline is within the 48-hour cutoff for new outreach, Atlas should not initiate new applicant outreach for this item. Any direct Dr. Miltie participation would require a legitimate substantive policy basis and must not be inferred from the existence of the comment period alone.
Official sources: CMS Negotiation Program regulations, guidance, and policy documents; CMS fact sheet.