Article
What the guidance covers
The draft, released July 16 and published in the Federal Register today, sets out how manufacturers must give access to the maximum fair price for selected drugs in 2028, the first year negotiated prices extend to drugs paid under Part B as well as Part D. Hospitals, physicians and other providers that administer these drugs are treated as Part B providers. Comments are due Sept. 18, and CMS expects to finalize the guidance this fall.
Manufacturers can meet the requirement in one of two ways. They can sell the drug to the provider at no more than the negotiated price up front, or they can pay a refund afterward equal to the difference between the provider’s acquisition cost and that price. CMS is weighing four ways to set a standard default refund amount, based on either wholesale acquisition cost or average sales price data. Refunds would be due within 14 days after CMS’s Medicare Transaction Facilitator sends the manufacturer the claim data showing the drug went to an eligible patient.
Where hospitals carry risk
- Cash flow. If manufacturers choose refunds, hospitals will buy high-cost infused drugs at full price and wait for claims to be processed and data sent before money comes back. For oncology and other infusion-heavy service lines, that float could be significant.
- Underpayment. A standard refund amount may not match what a given hospital actually paid. The choice among the four options matters.
- 340B overlap. The law says manufacturers need not provide the negotiated price when the 340B ceiling price is lower, and must avoid duplicate discounts when it is higher. CMS says it is not taking on responsibility for policing that overlap, which leaves manufacturers and covered entities to sort it out. CMS is also asking whether claims should carry 340B modifiers and NDC-level drug codes.
- Medicare Advantage. CMS may require MA network contracts to make providers enroll in the transaction facilitator, and patient coinsurance in MA would be based on a price no higher than the negotiated one.
What to do before 2028
CMS strongly encourages Part B providers to enroll in the facilitator’s data module, and manufacturer onboarding is planned to start by May 1, 2027. Leaders should assign pharmacy, revenue cycle and finance owners now. Identify which of your high-volume Part B drugs are likely to be affected, estimate the cash tied up under a refund model, confirm your claims can carry NDC and 340B data, and decide whether to comment on the refund options.
Archive entry for Jul 20, 2026, added Nov. 11, 2026.
Sources
- Fact sheet: Draft guidance on manufacturer effectuation of the MFP for IPAY 2028 (CMS, Jul 16, 2026)
- Medicare Drug Price Negotiation Program: regulations, guidance and policy documents (CMS, Jul 16, 2026)
- Medicare Drug Price Negotiation Program draft guidance; comment request (Federal Register, Jul 20, 2026)