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Centers for Medicare & Medicaid ServicesAnnouncement: Inflation Reduction Act and Medicare.

December 20, 2024

*NEW! Pharmacy and Dispensing Entity Resource Page, Draft Medicare Transaction Facilitator Agreements, Maximum Fair Price Explanations, and January 2025 Average Sales Price Files*

*New! Medicare Drug Price Negotiation Resources for Pharmacies, Mail Order Services, and Other Dispensing Entities*

CMS released a new Medicare Drug Price Negotiation Program resource page [ https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation/resources-pharmacies-and-dispensing-entities ] for pharmacies, mail order services, and other dispensing entities (“dispensing entities”). This page hosts a new Fact Sheet [ https://www.cms.gov/files/document/pharmacy-and-dispensing-entity-mtf-fact-sheet.pdf ], Frequently Asked Questions [ https://www.cms.gov/files/document/pharmacy-and-dispensing-entity-mtf-faq.pdf ] (FAQ) document, and is designed to provide dispensing entities impacted by the Medicare Drug Price Negotiation Program with a one-stop shop for information related to the Medicare Transaction Facilitator (MTF) and the effectuation of negotiated maximum fair prices (MFPs). The MFPs from the first cycle of negotiations will go into effect on January 1, 2026.

Importantly, CMS will use this webpage as an ongoing resource to share up-to-date information on critical pharmacy topics related to the MTF data and payment modules, which are a core component of implementing the Medicare Drug Price Negotiation Program, and, specifically, MFP effectuation. We intend to periodically publish key updates and information for pharmacies and other dispensing entities that will engage with the new MTF system. The webpage will include information such as factsheets, FAQs, timelines, and other resources related to pharmacy and dispensing entity engagement with the MTF. Initial topics include information about MTF pharmacy enrollment, CMS collection of pharmacy information for operating the MTF, draft MTF agreements for pharmacies to sign, and guidance on how to provide questions, input, and feedback to CMS throughout the process of establishing the MTF. This webpage is designed to be a resource to support dispensing entities, including ahead of MTF enrollment, which CMS anticipates beginning in late Spring of 2025. CMS encourages dispensing entities and their third-party support entities to review this webpage frequently for updates.

*New! Draft Medicare Transaction Facilitator (MTF) Agreements*

The draft MTF Agreements are now available on CMS’ Medicare Drug Price Negotiation website [ https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation ]. Parties to the agreements will include CMS; CMS’ contractors working to establish and operate the MTF system; participating drug manufacturers of selected drugs with negotiated maximum fair prices (MFPs) for 2026 and 2027; and the pharmacies, mail order services, and other dispensing entities that dispense the selected drugs to MFP-eligible individuals. CMS invites public feedback on the draft agreements, including their specific terms and conditions. The feedback period is open for 45 days, closing on January 31, 2025, at 11:59pm PST. Written feedback can be submitted to CMS via email to IRARebateandNegotiation@cms.hhs.gov_ _with the subject line “MTF Agreements Feedback”.

*New! Maximum Fair Price (MFP) Explanations for the Negotiated Prices*

The MFP explanations for the negotiated MFPs for the 10 drugs covered under Medicare Part D that were selected for the first cycle of negotiation are now available; the MFPs will go into effect on January 1, 2026. The MFP explanations, which are required by the IRA, provide information about CMS’ perspective on the data that had the greatest impact on CMS’ determination of offers and consideration of counteroffers consistent with the factors outlined in the IRA. Each MFP explanation includes details that are unique to the negotiation for that particular drug, along with information about the data received from participating manufacturers and the public, the exchange of offers and counteroffers, and the negotiation meetings. Consistent with the confidentiality policy in CMS’ revised guidance, the MFP explanations include redactions to protect proprietary information. These MFP explanations are now available on the CMS’ Medicare Drug Price Negotiation website [ https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation ].

*New! Reduced Coinsurance for Certain Part B Rebatable Drugs Under the Medicare Prescription Drug Inflation Rebate Program*

Today, CMS announced that some Medicare enrollees will pay less for 64 drugs available through Medicare Part B. The drugs will have a lowered Part B coinsurance rate from January 1, 2025 – March 31, 2025, since drug companies raised prices for each of these 64 drugs faster than the rate of inflation. 

CMS posts payment information each quarter for separately payable Part B drugs, including the Part B rebatable drugs subject to the coinsurance adjustments, in the Medicare Part B Quarterly Sales Pricing (ASP) files, which are publicly available on CMS.gov. The January 2025 ASP files also include the coinsurance adjustments for certain Part B rebatable drugs as required by the IRA. The Part B drugs impacted by a coinsurance adjustment may change quarterly.

You can find the new January 2025 ASP file here [ https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files ] and the fact sheet here [ https://www.cms.gov/files/document/reduced-coinsurance-certain-part-b-rebatable-drugs-january-1-march-31-2025.pdf ]. 

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