CMS Sets Dates for Drug Negotiation Program

By Sept. 1, 2023, the Centers for Medicare and Medicaid Services (CMS) will publish the first 10 Medicare Part D drugs selected for the Medicare Drug Price Negotiation Program under the Inflation Reduction Act. This legislation, signed by President Joseph R. Biden in August 2022, permits Medicare to directly negotiate prices for certain high expenditure, single source Medicare Part B or Part D drugs.

CMS officials said in a press release that they will engage with the public for feedback and insights as they implement the program. They plan to conduct stakeholder calls, quarterly strategic meetings, and monthly technical calls with CMS staff, as well as solicit comment on the draft program guidance.

By the spring of this year, CMS will issue guidance for the negotiation process and data collection and invite public comment on key elements. The negotiated maximum fair prices for the 10 drugs that are chosen will be announced by Sept. 1, 2024, and prices will be in effect starting Jan. 1, 2026.

Related: Webinar: Inflation Reduction Act Will Be Positive for Medicare

Negotiated drugs are expected to save Medicare $102 billion over six years, or about 10% of drug spending annually, Rena Conti, Ph.D., associate research director of Biopharma & Public Policy at Boston University Institute for Health System Innovation & Policy, said at a webinar held in August 2022.

Other key dates:

• By Feb. 1, 2024, CMS will send initial offers of a maximum fair price with a justification for a selected drug to each company participating in the Negotiation Program.

• By Sept. 1, 2024, CMS will publish maximum fair prices for drugs selected for negotiation for 2026

• In future years, CMS will select for negotiation 15 more Part D drugs for 2027, 15 more Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year after that.