CMS proposes codifying Medicare drug price negotiation program

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to codify the Medicare Drug Price Negotiation Program (MDPNP). The proposal aims to establish new policies for the initial price applicability year of 2029 and subsequent years.

Under the proposed rule, the fourth and subsequent negotiation cycles will include up to 20 additional negotiation-eligible drugs, bringing the total to nearly 60 drugs. The program, established by the Inflation Reduction Act of 2022, is designed to negotiate maximum fair prices for high-expenditure, single-source drugs and biological products.

Currently, the MDPNP is in its third cycle, negotiating prices for 15 drugs, with agreed-upon prices expected to take effect on January 1, 2028. The new rule seeks to provide long-term certainty for participating drug manufacturers while supporting innovation.