CMS releases draft guidance on the Medicare Drug Price Negotiation Program

NCPA May 6, 2024

CMS has released draft guidance on the Medicare Drug Price Negotiation Program. Comments on the draft guidance are due July 2, and NCPA will be submitting comments. This draft guidance outlines new requirements for the second cycle of negotiations, which begins in 2025 and will result in maximum fair prices (MFPs) effective for 2027. This draft guidance also includes additional policies regarding how participating drug companies will make any agreed upon negotiated prices available in 2026 and 2027. Topics covered in the draft guidance include:

  • Requirements and parameters for exchange of data among pharmacies and participating drug companies, via a Medicare Transaction Facilitator (MTF), to provide data needed to facilitate access to MFPs of selected drugs for pharmacies and to provide claim-level data.

  • Solicitation of comment on options for the MTF to provide a voluntary payment facilitation functionality for participating drug companies and pharmacies to help support access to the MFP.

  • Requirements participating drug companies must meet in making the MFP available to pharmacies.

NCPA