OBJECTIVES: Translational Coverage of Emerging Technologies (TCET) is a proposed rule that aims to expedite Medicare coverage for breakthrough-designated (BDD) devices for up to 5 years. Combined with the EU Medical Device Regulation (MDR), the medical device coverage and reimbursement landscape is rapidly evolving. This study seeks to identify US pathways for BDD devices and provide strategic considerations for reimbursement in the evolving landscape.

METHODS: The TCET proposed rule and public comments to its predecessor rule were analyzed. Further, the current payment and coverage pathways available to BDDs in the US were assessed and compared. Those included National Coverage Determination (NCD), Local Coverage Determination (LCD), New Technology Add on Payment (NTAP), Transitional Pass-through (TPT), Coverage with Evidence Development (CED), and FDA-CMS’ parallel review. Eligibility criteria, timelines, pros, cons, and risks were assessed across various payment and coverage pathways to help manufacturers navigate potential reimbursement pathways if TCET is implemented.

RESULTS: TCET may impact 300+ breakthrough devices, however, CMS expects 5 devices per year to qualify. Eligibility relies on post-launch evidence, including real-world data. Unlike parallel review that involves simultaneous review and decision-making between FDA and CMS, engagement with CMS can now begin prior to FDA market authorization. After a device’s TCET coverage expires, devices may transition to traditional NCD, LCD, or case-by-case coverage.

CONCLUSIONS: TCET and MDR regulations will raise the evidence thresholds for device coverage in the US and EU. TCET may offer a uniquely low-risk but high-reward, guaranteed pathway to Medicare coverage and potential commercial coverage, reducing the lag and variability in BDD coverage. Given uncertainty about transition to NCD, LCD, or non-coverage at TCET expiration, manufacturers should conduct a benefit/risk analysis to determine if opting-in to TCET is advantageous and explore alternative pathways in the US.