Medicare Drug Price Inflation Rebate Invoice Distribution Will Start In 2025, CMS Says

Coinsurance for Part B drugs may reflect rebates by April, and sponsors are already liable for them, but payments will be delayed several years as CMS develops its systems. Agency seeks comment on how to account for 340B discounts and make allowances for drug shortages, among other issues.

CMS Using Timing Flexibility Allowed By Law In Implementing Rebate Program • Source: Shutterstock

The Centers for Medicare and Medicaid Services will not begin sending out invoices for price inflation rebates owed by manufacturers on Parts B and D drugs until 2025 even though rebate liability has already begun, according to the agency.

The delay in releasing invoices is allowed by the Inflation Reduction Act, which established the rebate program, and will give...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By 

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

 
• By 

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

More from Pink Sheet

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.