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)
- 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
- Context ("Rationale for study is well supported," "Study is not unnecessarily duplicative," etc.)
- Protocol ("registered with Clinical Trials.gov")
- Data quality
- Data use
- Design - Subpopulations ("Must discuss subpopulations...")
- Reproducibility (e.g. analysis is robust to alternative analyses)
- Legal (e.g. medical care, not simply testing toxicity in health individuals)
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.