AAMC Responds to CMS Proposed Rule on Medicare Drug Price Negotiation Program

The AAMC submitted a letter responding to a proposed rule (PDF) from the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program (MDPNP). In the proposed rule, the CMS seeks to codify the MDPNP and establish certain new policies for it and the Medicare Prescription Drug Benefit Program, as required by the Inflation Reduction Act of 2022 (P. L. 117-169). In its Aug. 14 comments, the AAMC urged the CMS to adopt a requirement that drug manufacturers effectuate the Maximum Fair Price (MFP) prospectively. Retrospective approaches to MFP effectuation have not only resulted in operational difficulties, the letter noted, but have been a central justification for drug manufacturers advocating for rebate models in the 340B Drug Pricing Program [refer to Washington Highlights, Sept. 20, 2024]. Under a prospective approach, non-340B pharmacies would purchase drugs at MFP up front, while 340B covered entity pharmacies would be able to purchase 340B drugs with upfront 340B discounts, allowing both programs to operate without disruption.