Regulatory NewsBREAK: CMS Issues Revised Draft Guidance for IPAY 2028

On July 16, 2026, the Centers for Medicare and Medicaid Services released revised draft guidance on how manufacturers must effectuate the Maximum Fair Price (MFP) under the Medicare Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028. 

The guidance provides a framework for Part B MFP effectuation, including: 

• How manufacturers may provide the MFP through prospective discounts or retrospective refunds. 
• The role of the Medicare Transaction Facilitator (MTF) in supporting Part B payment and data exchange processes. 
• Data flows among manufacturers, Part B providers, Medicare Advantage organizations, and CMS. 
• Operational requirements for hospitals, physicians, suppliers, and other providers furnishing selected Part B drugs. 
• How MFPs will interact with existing Part B reimbursement methodologies.  

Although the guidance's primary focus is Part B, CMS also updates the existing Part D framework, with updates including: 

• Technical refinements to MTF operations. 
• Additional guidance on claims processing and refund transmission. 
• Clarifications regarding dispensing-entity participation. 

The draft guidance does not appear to fully resolve several major concerns previously raised by stakeholders. Issues that remain unresolved include: 

• How CMS will prevent duplicate discounts involving MFP transactions and other federal pricing programs, including 340B.  
• Performance standards, testing requirements, and transparency metrics. 
• Protections for provider cash flow and acquisition-cost variability under Part B's buy-and-bill system.  
• Potential patient access disruptions and provider willingness to stock selected drugs.  

Comments are due September 18, 2026.  

More on This Topic: 

• Revised Draft

For questions, please reach out to Geni Tunstall.