Wednesday, September 7, 2022

AHRQ Revisits "Requirements for Coverage with Evidence Development"

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.



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:

The 35-page reference document is here:

See a cloud zip file with the draft and attachments here.