CMS released a proposed decision memo June 15 that would substantially reshape Medicare coverage for transcatheter aortic valve replacement, and the nation’s leading cardiology and cardiothoracic surgery societies have responded with mixed reactions.
The proposed national coverage determination would end coverage with evidence development requirements for TAVR in patients with symptomatic severe aortic stenosis. It would simultaneously expand coverage to patients with asymptomatic severe aortic stenosis under a new Coverage with Evidence Development framework, revise operator and facility volume requirements, and preserve the multidisciplinary heart team model, though with new flexibility around how evaluations are conducted. CMS is accepting public comments through July 15, with a final decision expected in September.
The Society of Thoracic Surgeons was among the first organizations to respond.
“We are disappointed that the June 15 proposed decision memo from CMS does not fully reflect the priorities of STS,” President Vinay Badhwar, MD, said in a letter to the society’s members. “Throughout this process, we have focused on the following over-arching goals: to protect the heart team, preserve the value of evidence-informed decisions, and avoid disruption of optimal case adoption and safety. We intend to specifically note these concerns in the open comment period.”
STS’s primary objections center on the rollback of CED requirements and on provisions that would allow TAVR to be performed by a single interventional cardiologist without a cardiac surgeon present — a possibility the society had fought to prevent.
“Cardiothoracic surgeons bring essential expertise to the heart team,” Dr. Badhwar said. “The quality and safety standards built into the prior NCD are critical evidence-based protections for patients, particularly for complex patients and evolving indications.”
The American College of Cardiology offered a more neutral response, noting it is still reviewing the 100-plus-page proposed decision memo and will submit formal comments before the July 15 deadline. The group has said the proposal aligns with its long-held position that the existing CED framework has generated substantial real-world evidence in symptomatic patients — while acknowledging that targeted evidence development remains necessary for populations where clinical uncertainty persists, including asymptomatic patients.
“The ACC remains committed to advancing policies that promote high-quality, patient-centered cardiovascular care, support appropriate access to TAVR, and reinforce strong program integrity and oversight,” the group said in its response.
The Society for Cardiovascular Angiography and Interventions, which surveyed 267 members and hosted a public town hall in early June ahead of the CMS release, was similarly restrained in its initial reaction.
“While SCAI continues to evaluate the proposal in detail, many elements align with themes consistently emphasized by stakeholders, including the importance of preserving the heart team, maintaining appropriate quality oversight, protecting patient access, and providing greater flexibility for physicians and TAVR programs,” SCAI President J. Dawn Abbott, MD, said in a statement.
SCAI’s pre-release member survey offered a window into why the interventional cardiology community’s reaction is nuanced. While 76% of respondents said the current TAVR NCD should change, 85% supported requiring heart team consultation in some form, and 68% supported maintaining registry reporting requirements. Nearly 59% opposed continuing CED requirements for new indications — a position broadly consistent with what CMS ultimately proposed for symptomatic patients — but the question of single-operator procedures split the field, with 41% supporting a two-operator requirement with greater flexibility and 38% supporting a single-operator option.
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