In the past month, Medicare calendared a December 7, 2022, MEDCAC (advisory meeting) on its Coverage with Evidence Development Paradigm, and AHRQ issued a report on CED to date.
Now, CMS has published a JAMA article on coverage for early technologies, AND, opened registration for the December 7 webinar event.
Find the JAMA article here:
See trade journal coverage of the JAMA article here:
Find the Fed Reg announcement of the December 7 event here:
Find the registration for December 7 here (scroll down for reg)
AHRQ's draft report, which will be the core discussion document on December 7, is here:
From a separate workstream, at Tufts University, see a new paper on "Improving Medicare Coverage" by Tunis et al.
Regarding the JAMA Fleisher article, see comments below; I think there may be more content or at least as much value and material in a slightly later article by Dhruva et al in NEJM - here.
Here are the four bullets of the proposed plan, as per JAMA:
- Manufacturers may enter the process on a voluntary basis. This process will be limited to medical devices that fall within the Medicare statute and are relevant to the Medicare population.1
- The CMS may conduct an early evidence review (before the device secures FDA marketing authorization) and discuss with the manufacturer the best Medicare coverage pathway, depending on the strength of the evidence collected.
- At the manufacturer’s request, CMS may initiate the coverage review process before FDA market authorization, which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.
- If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufacturers, clinicians, and patients while maintaining rigorous evidence requirements.
I made a mid-September five minute video guide to what's happening -