The Transitional Coverage for Emerging Technologies Pathway will expedite the coverage of certain FDA-designated breakthrough devices, according to an Aug. 8 news release from the agency.
Each year, CMS will accept up to five TCET candidates and aims to finalize a national coverage determination within six months of a device’s FDA market authorization.
The TCET pathway is voluntary and will incorporate evidence preview and development planning stages, allowing manufacturers to address evidence gaps through fit-for-purpose studies tailored to the Medicare population. The pathway will also help determine the device’s appropriate Medicare benefit category, the release said.
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