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Industry Proposes TCET Timeline, CED Changes During CMS Stakeholder Call

 
• By Hannah Daniel

Medtech industry members presented comments to CMS about their concerns with the TCET proposal, including issues involving the FDA’s breakthrough device program.

A stethescope overtop of a pile of money on a wooden deck
• Source: Shutterstock

Device industry members have some suggestions for the Center for Medicare and Medicaid’s (CMS) Transitional Coverage of Emerging Technologies proposed rule.

Right now, the proposal would involve transitional coverage of breakthrough devices through a coverage with evidence development (CED) approach. Breakthrough device manufacturers will have to submit a literature review to CMS to explain what gap their device is filling, and then provide evidence that their device is doing so throughout the transitional coverage period

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