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FDA, Medicare And The Future Of Coverage With Evidence Development For Accelerated Approvals

 
• By Cathy Kelly

Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.

Will Reimbursement Continue To Be Bumpy After Accelerated Approval? • Source: Shutterstock

The Centers for Medicare and Medicaid Services should take a page from the US Food and Drug Administration's playbook when it comes to the way it educates stakeholders about its coverage with Medicare evidence development policy for accelerated approvals, suggested former CMS chief medical officer Sean Tunis, now a principal with Rubix Health.

Key Takeaways

  • CMS should release more detailed guidance on CED and Congress may need to pass legislation clarifying and codifying the policy.

  • CMS could be an...

Specifically, CMS should develop detailed guidance on when it will use Medicare coverage with evidence development, what that evidence development should entail and how real world data could factor in,...

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