New Coverage Process to Help CMS Speed Breakthrough Device Approvals

Two years after its repeal of a rule that would have expedited Medicare coverage for FDA-cleared Breakthrough Devices, CMA Thursday issued a request for comment on a process to provide “transitional coverage for emerging technologies” (TCET). 

As it said on its blog when retracting the 2021 rule, CMS developed the first version of its plan to expedite coverage of Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT) rule, “in part due to concerns that delays and uncertainty in Medicare coverage impaired beneficiary access to important new and innovative technologies, specifically those designated as breakthrough devices by FDA.”

The notice describes several pathways for coverage under TCET, starting with the current claim-by-claim adjudication process in which the Medicare Administrative Contractor (MAC) determines if the claim is “reasonable and necessary” for a patient. 

Coverage would also be possible when an MAC creates a “local coverage determination” — a local coverage policy for the device for the geographic area that MAC serves. 

Comments are due Sept. 19. 

Read the Federal Register notice here.

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