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US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo

 
• By Laura Helbling

The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials.

health care payment
The CMMI accelerated approval payment demo is not on hold, but undergoing further discussions. • Source: Shutterstock

The US Medicare agency is reconsidering a proposal to set differential payment levels for accelerated approval drugs based on continued dialog with the US Food and Drug Administration about whether the agency’s newly enhanced AA authorities will ensure confirmatory trials are completed in a timely fashion.

Key Takeaways

  • A proposal to set different payment levels for accelerated approval drugs is slowing amid more conversations between CMS and the FDA on whether it is still needed.

  • New FDA authority may make the demo unnecessary, Fowler said

The FDA has “indicated that new authority potentially may suggest the need for further examination” of the proposed Accelerated Clinical Evidence model, Center for Medicare and Medicaid Innovation Director Elizabeth Fowler said at a House Energy and Commerce Health Subcommittee 

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