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Accelerated Approvals In Medicare: CED Guidance Notes Ongoing Concern With Surrogate Endpoints

 
• By Cathy Kelly

Medicare coverage with evidence development final guidance includes few substantive changes from the proposed version despite biopharma stakeholder concerns.

Medicare CED Is Something Manufacturers Should Pay Attention To • Source: Shutterstock

The US Centers for Medicare and Medicaid Services does not rule out the possibility of imposing its own data collection requirement on Medicare Part B drugs with accelerated approvals from the Food and Drug Administration in its recently issued final guidance on Medicare coverage with evidence development.

Key Takeaways

  • The Centers for Medicare and Medicaid Services did not exempt FDA-approved drugs from the purview of Medicare coverage with evidence development in its final CED guidance, despite stakeholder requests.

CMS uses coverage with evidence development (CED) in national coverage determinations to condition Medicare coverage on the ongoing collection of...

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