Wednesday, February 1, 2023

CMS Gears Up for Feb 13/14 MedCAC on CED: Download Background, Speakers, Presentations

Update: See a Hogan Lovells summary of the MedCAC days, here.


Back in September 2022, CMS announced a MedCAC (public panel workshop) on Coverage with Evidence Development.  Back in November 2022 they pushed the date from December 2022 to February 2023.  Now, they've posted details, agenda, panelists, speakers,  and background materials.

Although we don't read the word "TCET" on the page, the meeting is widely viewed as part of the Biden administrations to boot up a program or policy package called "Transitional Coverage for Emerging Technologies."   This has been proposed to develop and be defined, as a replacement for "MCIT" Medicare Coverage for Innovative Technologies under the Trump administration.  The MCIT, which was never put in effect, linked coverage to FDA breakthrough status.

Find it all here:

See a wide range of materials:

  • Registration link (your email)
  • Roster
  • Questions
  • Agenda
  • Speakers
  • Written public comments
  • Background materials (incl. tables for AHRQ review)
  • Presentations [includes 58 p AHRQ deck]
  • AHRQ review document "Requirements for Coverage with CED"
  • Original Federal Register notice
Some of the above resources like "Agenda" are simply downward extensions of the webpage.

The agenda includes a summary of the AHRQ question review by Jodi Segal MD of Johns Hopkins.  Public comments run from 11:30 to 12:50.  There are 14 speakers, such as Medtronic, AdvaMed, American College of Cardiology, MITA, SNM, and others.  There are a few minutes for open mic public comments after lunch, then the panel discusses the key questions.

Panelists are asked to score the importance of the following aspects of CED:
  • Sponsor
  • Communication
  • Governance
  • Context ("Rationale for study is well supported," "Study is not unnecessarily duplicative," etc.)
  • Protocol ("registered with Clinical")
  • Population
  • Generalizable
  • Data quality
  • Data use
  • Design - Subpopulations ("Must discuss subpopulations...")
  • Reproducibility (e.g. analysis is robust to alternative analyses)
  • Reporting
  • Sharing
  • Legal (e.g. medical care, not simply testing toxicity in health individuals)
The panel, chaired by Joseph Ross MD of Yale, includes guest members Dr. CaƱos of CDRH, Dr. Umscheid of AHRQ, and Dr. Hodes, NIA/NIH.

Part of the AHRQ pre-work was to have 9 experts rate about 20 bullet points as "2" (essential) "1" (important) or "0".   See the webpage link "background materials" or click to enlarge the figure below.  4 were rated "2" by all reviewers, and 3 more were rated "2" by almost all reviewers.

AHRQ / Click to enlarge / Background materials