Final TCET Rule Spurs Disappointment Over Yearly Limit, Exclusion Of Technologies

Medical device groups expressed disappointment with CMS’ final Transitional Coverage for Emerging Technologies (TCET) rule, decrying the agency’s decision to limit the expedited Medicare coverage pathway to five devices a year and exclude technologies such as diagnostics and digital therapeutics from the pathway despite industry complaints about those provisions in the proposed rule. Some stakeholders say the final TCET rule underscores the need for Congress to pass the Ensuring Access to Critical Breakthrough Products Act (H.R. 1691), which would enable...