Thursday, October 13, 2022

Brief Blog: JAMA Article by CMS on CED/TCET. CMS Opens Registration for MedCAC on CED.

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.


According to the new JAMA article, CMS is working on a regulation that would allow it to review data before FDA approval and determine a coverage pathway (such as "local coverage vs national coverage" and "coverage with or without CED").   Honestly, this description makes it sound awfully close to "Parallel Review" ahead of FDA approval, something that has barely, ever, been used in its 10 years of existence.   But we'll see what develops.  

Here are the four bullets of the proposed plan, as per JAMA:

The CMS rule that is being developed will meet the following principles:

  1. 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
  2. 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.
  3. 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.
  4. 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.
The boldface red text both captures the key points of the JAMA plan, and, indicate areas that overlap with existing Parallel Review either explicitly or by common sense (obviously, CMS already would want to reduce, not raise, "unnecessary burdens," even if that phrase isn't explicit in parallel review).  


This events are the rolling out of a general program for technology coverage, which goes under the umbrella term "Transitional Coverage for Emerging Technologies" TCET.   CMS began holding town halls soliciting ideas on improving coverage last spring.   AdvaMed has a detailed white paper on the topic.    

I made a mid-September five minute video guide to what's happening -