On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a procedural notice with comment period on Transitional Coverage for Emerging Technologies (TCET), a new pathway that uses existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain breakthrough devices.
Under this new pathway, eligible US Food and Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for three to five years as the manufacturer develops evidence to address gaps identified through a contractor-generated evidence preview and pursuant to an evidence development plan (EDP).
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TCET is the successor to the Medicare Coverage of Innovative Technology (MCIT) pathway that was finalized in January 2021 rulemaking by the previous Administration and repealed in November 2021 by the current Administration.
Along with the proposed procedural notice for TCET, CMS published a blog post and a fact sheet. CMS also issued three guidance documents:
For more information, contact: Deborah Godes, Rachel Hollander, Paul Radensky, M.D. or Michael W. Ryan (McDermott Will & Emery – Partner).