The Centers for Medicare and Medicaid Services (CMS) has finalized updates to the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR), introducing significant changes to Medicare coverage requirements for patients with aortic stenosis.

Among the most notable changes, TAVR for symptomatic severe aortic stenosis is now covered without Coverage with Evidence Development (CED). Coverage for asymptomatic severe aortic stenosis remains limited to CMS-approved CED studies and requires an U.S. Food and Drug Administration (FDA)-approved indication. Because no CMS-approved CED studies for asymptomatic aortic stenosis currently exist, the procedure is not yet covered for these patients.

The updated policy also modernizes Heart Team requirements, allowing greater flexibility in multidisciplinary evaluation and permitting asynchronous review, provided both an interventional cardiologist and cardiac surgeon contribute to treatment decisions. CMS also removed the longstanding dual-operator requirement, allowing the Heart Team to determine whether one or two operators are appropriate for a procedure. Existing requirements for on-site interventional cardiology services, surgical backup, and intensive care capabilities remain in place.

The ACC has long emphasized that the Heart Team remains central to TAVR care, supporting comprehensive evaluation and informed decision-making for patients with complex structural heart disease.

In addition, the final NCD eliminates hospital TAVR volume thresholds and the requirement for registry participation as a condition of Medicare coverage. However, hospitals must have a continuous quality improvement process that "assesses procedural outcomes and makes necessary programmatic adjustments to assure patient safety." Registries may meet this requirement.

In a joint statement, leaders from the ACC, Society of Thoracic Surgeons (STS), and Society for Cardiovascular Angiography and Interventions (SCAI) recognized CMS for advancing Medicare coverage for TAVR and expanding patient access as evidence supporting the therapy continues to grow. At the same time, they emphasized the importance of preserving the quality framework that has contributed to the procedure's success.

"The preservation of the Heart Team, continued collaboration across specialties, collection of real-world evidence, outcomes monitoring and continuous quality improvement are the foundation of ensuring and improving outcomes for our patients with severe aortic stenosis," they said. "Participation in national registries, externally benchmarked quality programs and rigorous outcomes reporting remain essential to preserving the high standards of care that have defined TAVR's success."

CMS guidance on implementation of the NCD is still pending, with additional details expected in the coming months. The ACC will continue to provide updates to members and hospital and health system partners as information becomes available.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging

Keywords: ACC Advocacy, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Noncommunicable Diseases, Quality Improvement, Critical Care, Surgeons, Registries, Angiography