Health policy expert Joe Grogan, of USC's Schaeffer Institute, pens an Op Ed in the WSJ today, arguing that it is time to pull the plug on the arthritic and outdated "Coverage with Evidence" era at CMS.
CED was the heart of the "TCET" Transitional Coverage for Emerging Technologies" framework from the recent Biden administration.
Find Grogan's article here. (Grogan handled health policy for the White House in 2019-2020).
https://www.wsj.com/opinion/agency-overreach-leaves-patients-untreated-4ead2d0a
Medical innovations remain stuck between FDA approval and full Medicare coverage. Of 27 medical devices covered under CED since 2005, four have “graduated” to unrestricted coverage. Two product decisions were ceded to Medicare’s regional administrative contractors. The other 21 remain in limbo. Implantable cardioverter defibrillators languished under CED for 18 years. How much data does CMS need?
The program’s fatal flaw stems from confusion about agency roles. The FDA evaluates safety and efficacy. CMS’s mandate is to determine whether a product or service is reasonable and necessary to diagnose or treat an illness or injury. CED gave CMS free range to infringe on the FDA’s authority with predictable results: slowing access and blocking patients and doctors from making informed treatment decisions.
The program is also outdated. Unlike in 2005, digital health data is ubiquitous. The FDA can employ real-world evidence and artificial intelligence to analyze millions of patients’ treatments. CED’s clinical trial constructs are obsolete.
CED also restricts access by location, favoring urbanites who live near large academic medical centers over rural Americans. CMS should dramatically reform its process for making coverage decisions, with an eye toward speeding up access for patients. After decades of disappointing results, CED has earned its place in the regulatory graveyard.
Grogan does not mention, but where data is available, the program also strongly favored White participants (e.g. Amyvid PET trials).
Also not mentioned, there were publicly issued legal arguments against the use of CED in the 2020/2021 closing months of the prior Trump administration.
In recent comments, ACLA described the NCD change process as intolerably slow - here.
In recent comments, ACLA described the NCD change process as intolerably slow - here.
