CMS Issues Guidance on Part D Formulary Submissions

• On April 16, 2025, the Centers for Medicare and Medicaid Services (CMS) issued guidance on CY 2026 Part D Formulary Submissions (Guidance). 
• The Guidance includes important dates related to CY 2026 formulary submissions.
• CMS also outlined how it intends to assess formulary placement of drugs selected for negotiation under the Medicare Drug Price Negotiation Program of the Inflation Reduction Act (IRA): 
  • CMS will review formularies to identify:
    • whether selected drugs are missing from formularies. 
    • whether selected drugs are on a preferred tier and/or are on a lower cost-sharing tier than formulary alternative brand drugs in the same therapeutic class. 
    • instances where step therapy requires utilization of a formulary alternative brand drug prior to a selected drug 
    • instances where more restrictive utilization management (UM) requirements are imposed on selected drugs relative to a formulary alternative brand drug in the same therapeutic class. o CMS will communicate review concerns related to selected drugs that are not included on formularies during stage 1, and the remaining tiering and/or UM review concerns during stage 2.
  • If a Part D sponsor receives one or more review concerns, the Part D sponsor can address those concerns by resubmitting their formulary or by submitting a justification during the annual bid review process. 
    • Each justification should address applicable clinical factors, such as clinical superiority, non-inferiority, or equivalence of the selected and non-selected brand drugs.
    • Justifications should also address the design’s compliance with applicable statutory and regulatory requirements. 
    • CMS will evaluate these justifications and will only approve the bid if the benefit design and formulary comply with statutory and regulatory requirements. 

More on This Topic: 

• Guidance (posted in the memos section of HPMS) 

For questions, please reach out to Vicky Jucelin.