10/16/2025

CMS Releases Final Guidance for 2028 Medicare Drug Price Negotiations

The Centers for Medicare & Medicaid Services (CMS) has released final guidance for the Medicare Drug Price Negotiation Program’s 2028 cycle, marking the first year that Medicare Part B drugs will be included in negotiated pricing under the Inflation Reduction Act.

The guidance outlines policies for the third round of negotiations, which will include up to 15 additional drugs. Key updates clarify how CMS will assess Part B drug expenditures, incorporate Medicare Advantage data, and apply new rules for orphan drug exclusions under recent amendments in the One Big Beautiful Bill Act.

CMS also refined its process for identifying drugs eligible for renegotiation and adjusted the small biotech exception to cover both Part B and Part D drugs. Details on how CMS will apply the Maximum Fair Price for Part B medications will follow in future rulemaking.

Providers serving Medicare beneficiaries should monitor these developments, as negotiated pricing may affect reimbursement and access beginning in 2028. Background on the Medicare Drug Price Negotiation Program is available on the CMS Inflation Reduction Act page.