AHRQ publishes a proposal to edit and update "CED" requirements at Medicare. This is one activity in the run up to "TCET 2023," Transitional Coverage for Emerging Technologies.
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MCIT to TCET
Reimbursement experts will recall that the Trump administration developed a new program called "MCIT," which tied Medicare coverage to FDA "Breakthrough Device" status. The Biden administration formally canceled that, but promises a new program called "TCET," Transitional Coverage for Emerging Technology." Based on limited early information from CMS, TCET components likely will include pre-meetings with the CMS coverage group, and more use of Coverage with Evidence Development, or CED.
I always point out that MCIT was a complete policy program, whereas, as of now, TCET is a moniker for a basket of possible proposals still in the future.
See a two hour webinar on TCET from Stanford Biodesign and Duke Margolis Center, March 2022, here and here.
Sidebars: Academic Review of CED; CED and NPV
- See an academic review of CED by Zeitler et al, 2022 (entry point here).
- I argued in early 2022 that CED, as typically applied, was substantially value-destroying for companies subjected to it (here). I used an MBA-type net-present-value (NPV) model.
AHRQ Report Released - Comment September 7-28
At the request of CMS, AHRQ has issued a draft report on ways that CED rules might be edited and updated. This includes a public comment period September 7-28.
See the draft document, prosed edits to CED rules, and comment information here:
https://effectivehealthcare.ahrq.gov/products/coverage-evidence-development/draft-comment
The 35-page reference document is here:
See a cloud zip file with the draft and attachments here.
