The Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo on the National Coverage Determination (NCD) for TAVR, introducing changes to coverage pathways, evidence development and quality oversight.

CED and Quality Oversight

CMS has proposed ending Coverage with Evidence Development (CED) requirements for patients with symptomatic severe aortic stenosis (AS) while expanding CED to include patients with asymptomatic severe AS. This reflects a shift toward more targeted evidence generation, focusing CED on patient populations where additional data are needed to inform coverage decisions.

While CMS does not explicitly require registry participation, registries may continue to serve as a primary mechanism for data collection within CED-supported studies and broader quality measurement efforts. CMS also reaffirms the role of established outcome measures, including registry-based metrics assessing short-term mortality and major complications.

This approach is consistent with ACC's position that the existing CED framework has produced a substantial body of real-world evidence supporting TAVR in symptomatic patients, while highlighting the ongoing need for targeted evidence development in populations where clinical uncertainty remains. The ACC has also emphasized the importance of registry-based data collection, continuous quality improvement and longitudinal outcomes tracking to support patient safety.

Heart Team and Patient Evaluation

The agency has also proposed updates to heart team and patient evaluation requirements aimed at improving efficiency and access to care. The revised policy defines a minimum heart team of at least one cardiac surgeon and one interventional cardiologist and allows greater flexibility in how evaluations are conducted.

Initial triage may occur through chart review with one required in-person evaluation by a TAVR operator and a second evaluation optional, which may be conducted in person, via telehealth or through additional review. These updates retain the multidisciplinary heart team model while allowing greater flexibility in implementation.

The ACC has 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, there is continued recognition across the field of the role of heart teams in delivering coordinated, patient-centered care and supporting quality outcomes.

Facility Requirements and Operator Experience

The proposal would eliminate facility-level procedural volume requirements and instead establish broader expectations related to infrastructure, clinical capabilities and continuous quality improvement. Hospitals would be required to maintain on-site cardiac surgery and structural heart programs as well as appropriate critical care resources.
 
Citing evidence suggesting operator volume may be associated with patient outcomes, CMS has also proposed updated considerations related to operator experience. This change reflects a shift away from fixed volume thresholds and toward greater emphasis on outcomes and quality oversight.

Next Steps

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 College is reviewing the proposed decision memo and will submit formal comments before the July 15 deadline.

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

Keywords: Centers for Medicare and Medicaid Services, U.S., Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Medicare, Decision Making, ACC Advocacy, Policy