The Centers for Medicare & Medicaid Services (CMS) is proposing changes to how it covers transcatheter aortic valve replacement (TAVR).

The new framework removes the requirement for coverage with evidence determination (CED) for TAVR in patients with symptomatic severe aortic valve stenosis and extends coverage to asymptomatic aortic stenosis with a CED requirement.

The proposal would also allow patients to be evaluated by the heart team asynchronously via chart review, with only one in-person evaluation by a TAVR operator — either an interventional cardiologist or surgeon. It eliminates the requirement for both an interventional cardiologist and cardiac surgeon to take part in the procedure and eliminates hospital-level volume thresholds.

The deadline for public comments on the proposal is July 15.

Aakriti Gupta, MD, interventional cardiologist at Cedars-Sinai Medical Center in Los Angeles, said the proposal is a reasonable and appropriate evolution of the coverage policy.

“Over the past decade, this field has really matured,” she said. “TAVR is no longer an experimental therapy.”

Gupta added that she hopes that TAVR heart teams continue to participate in registries and track long-term outcomes “as a professional standard,” as has been seen on the surgical side.

“One of the reasons the field matured so responsibly is because of the STS/ACC TVT [Society of Thoracic Surgeons]/[American College of Cardiology] [Transcatheter Valve Therapy] registry, which has been such an enormous source of real-world knowledge, benchmark data, and safety surveillance,” she said.

Structured evidence generation will remain important for some frontiers of the field such as in younger patients, bicuspid aortic stenosis, repeat TAVR, valve-in-valve TAVR, and TAVR for pure aortic regurgitation, she said.

The American Association for Thoracic Surgery (AATS) is among the first medical societies to weigh in on the proposal publicly and has serious reservations about it.

“We believe the current framework represents a deeply problematic outcome that eliminates mandatory in-person surgeon evaluation of patients undergoing consideration of TAVR, intra-procedural surgical expertise potentially putting patients at risk, and rigorous examination of clinical outcomes,” AATS president Joseph Woo, MD, wrote in a letter to members.

AATS was involved in discussions with CMS and other medical societies on the proposed changes but declined to join an agreement to support the proposal because “it failed to incorporate several positions we consider essential to patient safety and optimal outcomes,” Woo’s letter said.

The society is concerned that the proposal eliminates the requirement that both a cardiac surgeon and interventional cardiologist act as dual co-operators during the procedure and asks that the final decision explicitly note that dual-specialty operators are optimal for patient care. They also want new TAVR sites to be required to use both specialists for at least the first year of operation.

“This requirement is especially critical in low-volume settings, where institutional infrastructure and heart team partnerships may still be developing and where close, formal collaboration provides an essential safety net for optimal patient care,” Woo wrote.

Like Gupta, AATS wants coverage with evidence development for the frontiers of the field, new TAVR sites, and newly approved TAVR valves.

The ACC and the American Heart Association said they were still analyzing the proposal and would submit formal comments.

Gupta reported receiving previous consultancy income from Edwards Lifesciences and Boston Scientific.

Brian Owens is a freelance journalist based in New Brunswick, Canada.