CMS Issues TCET Final Notice
Back
CMS announced its final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway, which would expedite Medicare coverage of certain FDA-designated Breakthrough Devices. CLS provided feedback (read feedback) on the originally proposed rule in August 2023.
CLS President and CEO, Mike Guerra, issued the following statement on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS):
“While we appreciate this first step CMS has taken to develop a pathway for innovative medical devices, the final TCET notice falls short of guaranteeing seniors’ timely access to breakthrough technologies and diagnostics. Specifically, limiting eligibility to only five technologies a year is unlikely to improve access or address disincentives to medical innovation caused by the current Medicare coverage process. It also remains unclear how CMS will prioritize nominations for the TCET pathway. CLS, on behalf of our members, remains focused on working with Congress to pass H.R. 1691, the Ensuring Access to Critical Breakthrough Products Act, which would provide immediate coverage and access for FDA-approved breakthrough designated products. It’s imperative that patients benefit from the most innovative safe and effective medical technologies developed to address their unmet clinical needs and aren’t left waiting for years to access these products.”
We will provide further analysis at a later date.
The TCET final notice is available here.
A fact sheet on TCET is available here.