ARTICLE SUMMARY:
CMS unveiled its Transitional Coverage for Emerging Technologies proposal last week—the agency’s second go-round at trying to streamline Medicare coverage of innovative new devices. Here’s Market Pathways’ initial analysis of the plan, with 10 key takeaways.
CMS’ latest proposal of a more streamlined coverage pathway for innovative medical devices isn’t likely to revolutionize the Medicare process for medtech, but it might provide benefits for several big-ticket devices per year and open up some additional supports to the broader innovator community.
After a series of delays over the past six months, the Medicare agency published its Transitional Coverage for Emerging Technologies (TCET) proposal June 22. CMS has been pledging to advance the policy since 2021, when it repealed the Medicare Coverage of Innovative Technologies. MCIT was the never-implemented attempt by the prior (Trump) administration to tackle the same issue, namely, challenges that innovative new devices face in gaining coverage following FDA approval, risking commercial prospects and scaring investors off from financing certain paradigm-changing projects in the first place. (See “MCIT Rule May Be Toast, But There’s More on the Medicare Menu, ”Market Pathways, September 20, 2021.)
Like MCIT, the new TCET proposal is a voluntary program directed at providing a streamlined path from regulatory authorization to national Medicare coverage for FDA-designated Breakthrough Devices. Unlike MCIT, the TCET path does not provide automatic or immediate coverage. There will be more process checks and evidence assurances required, and the approach will rely on the existing national coverage and evidence-development framework rather than create a new one. (See “CMS TCET Vision: Significant Change or Same Old Coverage Framework?” Market Pathways, June 3, 2022.)
Now medtech companies and advocates are poring over the details to assess likely real-world implications of the proposal. Here are 10 takeaways based on Market Pathways’ initial analysis of what CMS’ plan will do in practice to change the status quo.
