CMS Finalizes Expedited TCET Coverage Pathway For Some Breakthrough Devices, Excludes Digital Therapeutics

CMS on Wednesday (Aug. 7) finalized a new Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite Medicare coverage of some FDA-designated breakthrough devices, but appears to still leave out digital therapeutics. The agency anticipates accepting five breakthrough devices through the TCET pathway each year, a point that has drawn the ire of industry groups and lawmakers on Capitol Hill as too limited. Industry groups have long have backed the creation of the broader breakthrough device coverage rule pushed by...