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BioWorld - Sunday, July 13, 2025
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Home » US CMS wants earlier notification from manufacturers in revamp of TCET
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US CMS wants earlier notification from manufacturers in revamp of TCET

June 26, 2023
By Mark McCarty
U.S. Medicare coverage for breakthrough devices has been a hot topic for several years now, but industry is one step closer to making this policy dream a reality thanks to another new proposal from the Centers for Medicare & Medicaid Services (CMS). The agency released a new version of the Transitional Coverage for Emerging Technologies (TCET) program that seems to satisfy most of what med-tech trade associations sought, but the catch is that manufacturers must notify CMS of their intent to take part in TCET a year before the FDA will decide whether to grant market authorization to the device.
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