The ACC, along with the Society for Cardiovascular Angiography & Interventions (SCAI) and the Society of Thoracic Surgeons (STS), submitted formal comments to the Centers for Medicare and Medicaid Services (CMS) on July 15 regarding the proposed decision memo for the National Coverage Determination (NCD) for TAVR. The letter calls for targeted updates to the proposed policy, supporting patient safety, evidence-based care, nationally consistent quality standards and robust clinical data collection.

"TAVR's success has been built on multidisciplinary heart team decision-making, participation in audited national registries like the STS/ACC TVT Registry, and rigorous quality oversight," says ACC President Roxana Mehran, MD, FACC. "As CMS considers updates to the TAVR National Coverage Determination, the ACC, in collaboration with our partner cardiovascular societies, supports modernizing the policy while preserving these proven safeguards and creating a flexible pathway to evaluate new technologies and indications, ensuring all patients have access to high-quality, evidence-based care."

After thorough review of the proposed NCD, the societies urge the following:

1. Preserve the multidisciplinary heart team model by explicitly requiring evaluation of eligible patients with severe aortic stenosis (AS) by both an interventional cardiologist and a cardiac surgeon and maintaining collaborative decision-making as a required component of care.
2. Maintain a targeted Coverage with Evidence Development (CED) pathway for patient populations where important evidence gaps remain, including bicuspid AS, valve reintervention, asymptomatic severe AS, aortic regurgitation and moderate AS.
3. Maintain mandatory participation in a national audited registry, such as the STS/ACC TVT Registry, and clarify how registry participation may be used to satisfy CED requirements and support quality measurement requirements.
4. Preserve nationally standardized approaches to quality measurement, benchmarking and continuous quality improvement through registry participation and externally benchmarked performance assessment.
5. Adopt a programmatic approach to facility and operator requirements that prioritize institutional performance, multidisciplinary infrastructure and quality outcomes over rigid operator volume thresholds alone.

For more on the societies' feedback, access the full comment letter. The ACC remains committed to working with CMS to develop a final NCD that reflects both the strength of the evidence base and the expert consensus of the clinical community with the ultimate goal of promoting nationally consistent, high-quality care for all.

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

Keywords: STS/ACC TVT Registry, National Cardiovascular Data Registries, ACC Advocacy, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Policy, Centers for Medicare and Medicaid Services, U.S., Patient Safety, Quality Improvement, Registries, Data Collection, Evidence-Based Medicine