Header: Neumann et al. (TUFTS) propose wide expansion on Coverage with Evidence Development (CED) at CMS. Entry point for them is the recent TCET announcement.
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In early August, CMS finalized its plan for Transitional Coverage for Emerging Technologies (TCET, here). Basically, medical devices under FDA review by the Breakthrough Pathway can apply for early review by CMS and expect, usually, a National Coverage Determination with Coverage with Evidence Development (TCET-CED) within six months of final FDA approval. Entry point here. The online Federal Register document explains that, in general, clin lab diagnostics are excluded (a statement which is followed by several paragraphs about MolDx). CMS gives the TCET NCD program a bandwidth of 5 NCDs per year.
At STAT, Peter Neumann et al, of Boston University, describe the TCET program as-is, and make a number of recommendations for its expansion, and the wider use of CED. Find it here:
https://www.statnews.com/2024/08/28/medicare-ced-tcet-coverage-emerging-technologies-devices/
The authors write, Medicare should broaden the TCET program’s scope and ambitions. In practice, this could allow for new studies examining how emerging treatments for diabetes, heart failure, or Alzheimer’s disease affect the health and quality of life of Medicare beneficiaries in real-world settings. Such efforts would require additional resources for CMS. The Bipartisan Policy Commission has recommended up to $10 million per year to modernize the Medicare coverage process — a modest figure in light of Medicare’s trillion-dollar annual outlays, and [$10M is] an order of magnitude too small to make any meaningful difference.
Documented Bandwidth
One problem I covered recently, based in part on a FOIA request, CMS only produces about 4 total NCDs per year (including simple ones like deletions), and has a backlog of several years for NCD requests (my blog here.)
Which Means...
Let's bring this all together. Effective and impactful pragmatic trials (e.g. most CED) are among the hardest types of trial to design, raising questions about how much bandwidth CMS has to widen that program and follow-up 5 additional programs per year (20 would be open at once by Year 4). At equilibrium, CMS would be opening 5 CED NCDs per year and reviewing and closing the same number, so handling 10 NCDs per year for TCET alone.
Economics of CED Vary Widely
To quote from a section of my own August 7 blog.
- You rarely see a discussion of the economics of CED, but it works much better with high cost, high margin products. Consider a $50,000 drug. $5000 to manufacture, $3000 per patient per trial for management, gross margin is $42,000 per reimbursement.
- Now pivot to a $100 genetic test. $50 to manufacture. $300 per patient per trial for management, gross margin is NEGATIVE -$2950. I have never heard a CMS speaker who seemed to "get it" or be remotely aware of this policy aspect of CED.
Pragmatic Trials Tricky
CED registries often hinge on comparing results of participants to "virtual controls" or "administrativey matched controls." This can be fraught with difficulties and complexities - example from current new is here.
