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# New Pathway for Breakthrough Device Coverage
- URL: https://www.fdaweb.com/new-pathway-for-breakthrough-device-coverage/
- Published: 2023-06-23T12:00:00.000Z
- Updated: 2026-09-14T18:40:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154759

Centers for Medicare & Medicaid Services (CMS) has issued a proposed procedural notice outlining a new [Medicare coverage pathway ](https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc?ref=fdaweb.com)for breakthrough medical devices. “The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.”

CME says the new pathway uses current national coverage determination and coverage with evidence development processes to expedite Medicare coverage of certain breakthrough devices. “TCET is voluntary and aims to reduce uncertainty about coverage options through a pre-market evaluation of potential harms and benefits of technologies while identifying any important evidence gaps,” the agency says. “Additionally, the TCET pathway includes an evidence development framework that provides manufacturers with opportunities for increased pre-market engagement with CMS and, in an effort to reduce manufacturer burden, an unprecedented level of flexibility to address evidence gaps to support Medicare coverage. Specifically, TCET allows for any evidence gaps to be addressed through fit-for-purpose studies.”