CMS finalizes new Transitional Coverage for Emerging Technologies (TCET) pathway to ...
CMS published a final notice on August 12, 2024, detailing the Transitional Coverage for Emerging Technologies (TCET) pathway, which uses existing NCD and CED processes to expedite Medicare coverage for FDA-designated Breakthrough Devices. The TCET pathway aims to balance early beneficiary access, reduced coverage uncertainty, and evidence development, accepting up to five candidates per year. Eligibility is limited to Breakthrough Devices within a Medicare benefit category, not subject to existing NCDs, and not excluded by law. The pathway includes pre-market, coverage, and post-TCET stages, with CMS aiming to finalize an NCD within six months of FDA market authorization. CMS intends to review TCET nominations quarterly, with deadlines for submission.
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CMS published a final notice on August 12, 2024, detailing the Transitional Coverage for Emerging Technologies (TCET) pathway, which uses existing NCD and CED processes to expedite Medicare coverage for FDA-designated Breakthrough Devices. The TCET pathway aims to balance early beneficiary access, reduced coverage uncertainty, and evidence development, accepting up to five candidates per year. Eligibility is limited to Breakthrough Devices within a Medicare benefit category, not subject to existing NCDs, and not excluded by law. The pathway includes pre-market, coverage, and post-TCET stages, with CMS aiming to finalize an NCD within six months of FDA market authorization. CMS intends to review TCET nominations quarterly, with deadlines for submission.