Monday, February 27, 2023

MEDCAC on CMS Evidence Development: Scoresheets and Video Posted

On February 13/14, 2023, CMS held a two day workshop on "coverage with evidence development."  CMS has not yet posted a transcript, but, it has posted voting scoresheets as well as Day 1 and Day 2 videos.

  • Main web page here (very long vertically).
  • PDF Scoresheet here. (Link from the main web page).
  • Links for Video recordings, Day 1 and Day 2.  Here.  (At very bottom of the long web page, or search for "Video recordings" key word).
  • Brief  meeting summary from Hogan Lovells, Langbein et al., here.
  • A headline at Medtech Intelligence says that TCET policymaking will appear soon.
    • TCET stands for "Transitional coverage for emerging technology" and is an umbrella term for CMS innovation policies to-be-created.

For voting questions, CMS proposed 17 features of studies under CED to rank as not important (0), important (1), or very important (2).   Most votes were "2" because the criteria are collectively necessary.    (It's like asking,"Which are important, steering or brakes or engine? (check all that are important).")  

It's unclear how some of the requirements would be enforced, for example, #15 results must be made public within 12 months of completion.  If results were made public at 15 months, what would CMS do?  Take back money from a hospital in Omaha that had been a trial site and gotten a payment 3 or 4 years prior?   Issue a fine to the association that sponsored the study (say, American Cardiology Association?)  or its P.I.?   Unclear.