ARTICLE SUMMARY:
Market Pathways asked key medtech opinion leaders what’s good and what’s bad in CMS’ recently proposed streamlined coverage pathway. The overall message: the reforms have some positive elements but industry is still pressing for a more automatic and expansive framework, from the agency or Congress. Interviews conducted by Stephen Levin and David Filmore.
CMS’ recent proposal to create a streamlined framework for national coverage of new devices didn’t go as far as device policy advocates had hoped.
Rather than establishing a new coverage pathway in its Transitional Coverage for Emerging Technologies (TCET) plan posted in June, CMS stayed well within the bounds of the current National Coverage Determination/Coverage with Evidence Development (NCD/CED) framework. The agency proposes to front-load its NCD application process for select FDA Breakthrough Devices to accelerate data review and generate “fit-for-purpose” evidence development plans prior to FDA authorization, with a goal of issuing a final coverage policy within six months of regulatory approval. (For details on the specific elements of the proposal, see “10 Takeaways on TCET: Medicare’s Latest Medtech Innovation Proposal,” Market Pathways, June 27, 2023.)
The reforms have merit but they don’t sufficiently change the formula for potentially paradigm-shifting new technologies that currently struggle to attract investors due to an unpredictable reimbursement environment. That is the underlying message from multiple company executives and trade group leaders who offered input to Market Pathways in response to CMS’ TCET plan.
