CMS issued a final procedural notice outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies for people with Medicare.
The new TCET pathway for certain Food & Drug Administration (FDA)-designated Breakthrough Devices increases the number of NCDs that CMS will conduct per year and supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.
CMS anticipates accepting up to five TCET candidates per year and, for technologies accepted into and continuing in the TCET pathway, CMS’ goal is to finalize a national coverage determination (NCD) within six months after FDA market authorization.
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