Dive Brief:
- The Centers for Medicare and Medicaid Services has shared more information on its plans for a new breakthrough device reimbursement pathway.
- Writing in JAMA Health Forum, three CMS authors outlined the planned Transitional Coverage for Emerging Technologies (TCET) pathway and how it will affect devices at various stages of development.
- CMS’ efforts to finalize TCET received a boost late last month when medtech trade groups came out in support of the pathway, albeit while simultaneously pushing for changes to the proposals.
Dive Insight:
CMS released a draft version of TCET for consultation in June. In parallel, the organization prepared a paper that discusses how it developed the proposal and what it will mean for products at different stages of the life cycle, starting with early premarket authorization.
“When developing premarket clinical studies, we believe that manufacturers will be better positioned for multiple product development stages if they anticipate both FDA and CMS requirements. Therefore, we are articulating these evidence expectations so that manufacturers may efficiently demonstrate the appropriateness of their technology for Medicare beneficiaries,” the authors of the paper wrote.
CMS plans to publish a series of guidance documents that review health outcomes in priority therapeutic areas, starting with the review of clinical endpoints for knee osteoarthritis that the organization released in June. Detailed guidance on designing “fit-for-purpose” studies is scheduled for publication this year.
The rest of the paper addresses the impact of TCET on devices that are near market, early postmarket and postmarket. The authors call TCET “a substantial advancement” in CMS’ approach to coverage with evidence development for postmarket devices, explaining that the agency will expedite national coverage determination reconsideration “consistent with statutory requirements.”
Overall, the aim of TCET is to “accelerate national coverage where the evidence supports it,” the CMS authors wrote, and to “increase predictability while reducing the burden of evidence development.”