CMS Extends MitraClip Coverage to Functional MR, Carves Out Imager Role

After some unexpected delays, the US Centers for Medicare & Medicaid Services (CMS) has finally released its national coverage determination (NCD) for transcatheter edge-to-edge repair (TEER). This move extends Medicare reimbursement to include patients with functional (secondary) mitral regurgitation undergoing this type of transcatheter mitral valve repair, which for the time being means MitraClip.

CMS opened its review back in August 2019, with the open public comment period expected to wrap up in early 2020 and a final decision made in May. Instead, the proposed decision memo was released in July 2020.

MitraClip (Abbott) is the only currently approved device affected by the CMS announcement, although other clip-like devices are under investigation.

In the decision released last night, CMS finalized a number of requirements set out in its July proposal, including patient indications, heart team requirements, and procedural volumes. It’s these last two that are particularly noteworthy: while the NCD for TAVI in aortic stenosis similarly requires both a cardiologist and a surgeon who do the requisite number of procedures, the updated TEER NCD additionally specifies that an interventional echocardiographer and a heart failure cardiologist be part of the team (the latter only being required for functional MR patients). 

Heart failure physician signoff was also a requirement in the COAPT trial, on which Food and Drug approval was largely based and which remains a foundation for last night’s decision. For the heart failure doctor, the only requirement is that he or she have experience treating patients with advanced atrial fibrillation.

For the interventional echocardiographers, however, these may be either a cardiologist or an anesthesiologist, and these specialists need to have experience with at least 10 transseptal guidance procedures and 30 or more structural heart procedures. In addition, they must be board eligible or certified in transesophageal echocardiography, “with advanced training as required for privileging by the hospital where the TEER is performed.” Of note, if an anesthesiologist is doing the imaging guidance for the procedure, he or she “may not also furnish anesthesiology during the same procedure,” the NCD states.

Dee Dee Wang, MD (Henry Ford Health System, Detroit, MI), who was one of the earliest voices advocating for structural heart imaging—and the specialized training required—praised the agency for recognizing this crucial role in TEER.

“This is a win for interventional imaging physicians,” she told TCTMD. “As of last night, the CMS for the first time actually [specified] that an imaging physician needs to be in the room. Health system administrators who don’t do the procedure, who don’t necessarily know what your role is in that room say, ‘Why did you have to be in there and why can’t somebody else be in there? Or why can’t we just pull somebody in for this case, how difficult can it be?’ And that’s been a really big hurdle for people wanting to go into this field to advance the technology.”

By specifying that imagers must be involved and further defining the type of experience required, the CMS decision underscores the fact that this is a specific, highly trained skill set, said Wang.

“This is the first time that they have formally recognized this and that’s crucial for protecting the safety of this procedure and allowing for scalability,” Wang explained. “This gives health systems across the country, and future fellows, the opportunity to say: I can be doing these procedures.”

Wang, who praised the NCD writing committee for taking into account the recommendations made during the open comment period, said she hopes the CMS document can be a springboard for equalizing reimbursement for imagers, who typically earn a fraction of the RVUs allocated to proceduralists, even though they are in the room for the same number of hours. “That’s the next step of advocacy,” said Wang, “reallotting [among] the heart team model the reimbursement for these procedures so that it is equal among all the team players.”

A press release issued by Abbott hailed the CMS announcement, quoting Neil Moat, MD, chief medical officer of Abbott's structural heart business. "Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,” Moat said. “CMS’ decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival."

The agency had originally intended to finalize the TEER NCD in 2020. An Abbott spokesperson told TCTMD that they had expected to see the CMS decision by September 2020. The delays, she speculated, were presumably “just standard administrative delays, and likely some caused by COVID-19. We remained hopeful that CMS would release their final decision as a formal delay was never communicated—and we were very pleased to see it post to CMS’ website yesterday.”

The news comes within a month of new American Heart Association/American College of Cardiology valvular heart disease guidelines, which gives a 2A recommendation (“is reasonable”) to the use of edge-to-edge repair in degenerative patients largely mirroring those defined in the FDA indications, also cited in the CMS NCD.  

The Alliance for Aging Research too issued a statement saying, “We applaud CMS for the steps it has taken to advance innovation for Medicare patients, and we thank the agency for adopting recommendations from advocacy organizations representing patients, family caregivers, and providers outlined in our public comment submitted last fall and our July 2020 comment letter on the proposed NCD.”