The Society of Thoracic Surgeons (STS) continues to advocate for Medicare coverage policies that support patient safety, multidisciplinary decision-making, appropriate surgical involvement, and evidence-based care as transcatheter aortic valve replacement (TAVR) expands into new patient populations and indications.
Recent efforts have centered on two significant actions by the U.S. Centers for Medicare & Medicaid Services (CMS): the ongoing National Coverage Analysis (NCA) for TAVR for native aortic regurgitation (AR) and the recently finalized National Coverage Determination (NCD) for TAVR for aortic stenosis.
STS Urges Key Safeguards as CMS Considers TAVR Coverage for Aortic Regurgitation
STS has submitted comments to CMS on the NCA for TAVR for patients with native AR, calling for safeguards that preserve cardiac surgeon involvement, multidisciplinary decision-making, and continued evidence development as the therapy enters broader clinical practice.
The effort builds on STS’s extensive advocacy during CMS’s recent review of the national coverage policy for TAVR for aortic stenosis. As part of a joint effort with the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography & Interventions (SCAI), STS has emphasized the importance of in-person surgical evaluation, dual operators, and coverage with evidence development (CED).
STS also has independently emphasized to CMS that surgical involvement should be required, rather than optional, both in evaluating patients with isolated native AR and in performing TAVR for AR.
A Distinct Application of TAVR
TAVR for native AR is a novel and clinically distinct application of transcatheter valve therapy, with significantly less clinical trial data and real-world evidence than TAVR for aortic stenosis.
The difference in experience is substantial. The STS/ACC TVT Registry has recorded nearly 1 million patients undergoing TAVR across 850 U.S. sites since 2011, while the expanded ALIGN-AR study enrolled 700 patients with native AR across 30 U.S. centers through July 2025.
Native AR also presents distinct anatomical and procedural challenges that make appropriate patient selection, multidisciplinary decision-making, and procedural expertise especially important as the therapy enters broader clinical practice.
Safeguards for Evidence-Based TAVR Care
To address these concerns, STS is calling on CMS to include the following requirements in its coverage policy:
- Required in-person evaluation by both specialties: Patients with isolated native AR should be evaluated in person by both an interventional cardiologist and a cardiac surgeon.
- A two-operator model: TAVR for native AR should be performed jointly by an interventional cardiologist and a cardiac surgeon.
- Coverage with evidence development: The limited evidence supporting TAVR for native AR does not yet warrant the same degree of flexibility outlined in the recent TAVR national coverage policy for symptomatic aortic stenosis, and therefore, data for this procedure should be captured under the provisions of CED.
Preserving the Model That Generated the Evidence
The pivotal ALIGN-AR trial used a multidisciplinary heart team that included both interventional cardiology and cardiac surgery to determine surgical risk and treatment eligibility, as well as to perform the procedure.
STS believes Medicare coverage should reflect the framework under which the evidence supporting this indication was generated. Requiring both specialties preserves this multidisciplinary model while experience and real-world evidence continue to accumulate.
CMS Finalizes Updated NCD for TAVR Following Nine-Month Review
(originally posted on Sept. 11, 2026)
The Centers for Medicare & Medicaid Services (CMS) has issued its updated National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR), concluding a nine-month review process that included extensive engagement from The Society of Thoracic Surgeons (STS) and partner organizations representing the multidisciplinary heart team, including the American College of Cardiology (ACC), the Society for Cardiovascular Angiography & Interventions (SCAI), and the American Association for Thoracic Surgery (AATS).
The final NCD follows CMS' June 15, 2026, proposed decision to update the existing TAVR coverage policy. Throughout the review, STS provided extensive feedback and advocated for policies that preserve the multidisciplinary heart team model, maintain appropriate cardiac surgeon involvement in TAVR evaluation and care, and support continued evidence development as TAVR expands into additional patient populations and indications. View a comparison chart of the existing NCD, proposed changes, and final policy.
STS Advocacy Throughout the Process
STS was actively engaged throughout the NCD review, working both independently and as part of a multi-society coalition. The Society submitted formal comments, met with CMS officials involved in developing the policy, engaged CMS leadership, and participated in discussions with the NCD requester Edwards Lifesciences and other professional societies regarding areas of potential consensus.
Throughout the process, STS consistently advocated for three priorities:
- Preserving the multidisciplinary heart team model as an essential component of TAVR decision-making.
- Maintaining cardiac surgeon involvement in patient evaluation, treatment decisions, and TAVR care.
- Continuing evidence development in areas where important clinical questions remain unanswered.
STS also advocated for expanded evidence development requirements as TAVR moves into newer indications and lower-risk patient populations, including severe bicuspid aortic stenosis, moderate aortic stenosis, pure aortic regurgitation, valve-in-valve procedures, and patients at low surgical risk.
From the Existing Policy to the Final NCD
The original TAVR NCD, established in 2012, helped guide the measured adoption of TAVR in the United States by establishing coverage requirements that included participation by a multidisciplinary heart team and the availability of on-site cardiac surgical services.
CMS reopened the NCD in December 2025 following a request from Edwards Lifesciences. During the subsequent review, STS worked to ensure that an updated policy would recognize advances in TAVR while maintaining safeguards that support patient safety, multidisciplinary decision-making, and evidence-based care.
CMS released its final NCD on September 10, 2026. The NCD maintains requirements for hospitals to have on-site cardiac surgery capabilities and access to critical care resources and continues to recognize the multidisciplinary heart team. CMS removed coverage with evidence development (CED) status for severe symptomatic aortic stenosis (AS). It has approved TAVR for asymptomatic severe aortic stenosis but under the provision of CED.
CMS defined the heart team as at least one cardiologist and one surgeon, but also included advanced practice providers, nurses, and other members. While the suitability for surgical aortic valve replacement must be evaluated, the only mandated in-person visit is the TAVR operator. They state that another evaluation by an additional heart team TAVR operator is not required but is covered if performed. A single TAVR operator is acceptable, and it may be a cardiologist or surgeon. If determined appropriate by the heart team, a second operator would be supported and it may be a cardiologist or a surgeon.
What the Final NCD Means
The final policy maintains several important elements of the existing TAVR coverage framework, including:
- Continued requirements for hospitals to have on-site cardiac surgery capabilities.
- Continued access to critical care resources.
- Recognition of the multidisciplinary heart team.
- Coverage with evidence development for asymptomatic aortic stenosis.
Looking Ahead
STS will continue to monitor implementation of the final NCD and advocate for evidence-based TAVR care, patient safety, outcomes, and policies that support multidisciplinary decision-making, appropriate surgical expertise, and rigorous evidence development.
Summary: The final NCD maintains key elements of the existing TAVR coverage framework, including hospital requirements for on-site cardiac surgery capabilities and critical care resources, continued recognition of the multidisciplinary heart team, and CED for asymptomatic aortic stenosis. While the policy does not incorporate all of STS' recommendations regarding cardiac surgeon involvement and expanded evidence development, STS will continue working to ensure that patient safety, multidisciplinary care, and high-quality clinical evidence remain central to TAVR treatment and coverage decisions.
Our work does not end with the CMS announcement. This is an opportunity for every surgeon involved in valve therapies to stay actively engaged in your heart team, make every effort to evaluate all patients being considered for TAVR or SAVR, and apply all available evidence to provide informed decisions that protect patients. STS will continue to advocate for evidence-based policies that support multidisciplinary care, appropriate surgical expertise and the highest-quality care for patients with structural heart disease.
