The Centers for Medicare & Medicaid Services (CMS) has released its Proposed Decision Memo for the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination (NCD), opening a 30-day public comment period through July 15, 2026. The proposed decision includes several significant changes to Medicare coverage requirements for TAVR that will have important implications for patients, physicians, and programs across the cardiovascular community.  

Over the past several months, SCAI has actively engaged the interventional cardiology community through a SCAI member survey and a public town hall focused on the NCD review process. 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. 

Heart Team Requirements 

What CMS Proposed 

The Proposed Decision Memo maintains a Heart Team requirement while providing greater flexibility in how evaluations are conducted. CMS would require an in-person evaluation by the TAVR operator, while allowing greater flexibility for other Heart Team members to participate in the evaluation process. 

How This Compares With Member Feedback 

SCAI's member survey showed strong support for maintaining a Heart Team approach to patient care. SCAI members consistently emphasized that treatment decisions should be individualized and informed by multidisciplinary expertise. 

• More than 85% of survey respondents supported Heart Team involvement in some form
• 54.1% supported maintaining Heart Team consultation while allowing greater flexibility

Modernizing the Current Framework 

What CMS Proposed 

The Proposed Decision Memo includes several significant changes to the current framework, including: 

• Removal of Coverage with Evidence Development (CED) requirements for symptomatic severe aortic stenosis
• Coverage of TAVR for asymptomatic severe aortic stenosis under CED requirements
• Revised operator competency requirements
• Removal of hospital procedural volume requirements

How This Compares With Member Feedback 

More than three-quarters of respondents (76.1%) said the current TAVR NCD should change, including 34.4% who favored significant changes and 41.7% who favored moderate changes. 

Operator Flexibility 

What CMS Proposed 

The Proposed Decision Memo removes the requirement that TAVR procedures be performed by both an interventional cardiologist and a cardiac surgeon. 

Under the proposal: 

• TAVR procedures may be performed by a single operator
• When the heart team deems two operators necessary, coverage is provided as long as both are part of the heart team

How This Compares With Member Feedback 

Nearly 80% of respondents supported either a single-operator option or greater flexibility in operator requirements: 

• 41.0% supported maintaining a two-operator approach while allowing greater flexibility in who may serve as operators
• 38.4% supported allowing a single-operator option

Quality Oversight and Registry Reporting 

What CMS Proposed 

The Proposed Decision Memo continues to emphasize quality oversight and program infrastructure requirements designed to monitor patient outcomes and support continuous quality improvement while removing specific reporting mandates. 

How This Compares With Member Feedback 

Nearly 68% of respondents supported maintaining registry reporting requirements. 

Program Requirements 

What CMS Proposed 

The Proposed Decision Memo removes hospital procedural volume requirements and instead focuses on program infrastructure and quality processes, including: 

• On-site structural heart interventional cardiology and cardiac surgery programs
• Intensive care capabilities appropriate for managing patients undergoing surgical aortic valve replacement
• Continuous quality improvement processes that assess procedural outcomes and support patient safety

How This Compares With Member Feedback 

Members consistently emphasized the importance of maintaining high standards of care while providing programs with greater flexibility to meet the needs of their patients and communities. Survey comments frequently called for the removal of hospital volume requirements while maintaining quality standards and monitoring outcomes. 

Coverage With Evidence Development 

What CMS Proposed 

The Proposed Decision Memo would remove CED requirements for patients with symptomatic severe aortic stenosis while maintaining CED requirements for the newly proposed coverage indications of asymptomatic severe aortic stenosis. 

How This Compares With Member Feedback 

Survey respondents were divided on whether Coverage with Evidence Development requirements should continue for new indications, although a majority (59.3%) opposed continuing those requirements, while 40.7% supported retaining them. 

What Happens Next 

SCAI is continuing to review the Proposed Decision Memo and solicit member feedback to help inform the Society's formal comments to CMS before the July 15 public comment deadline.

Members are encouraged to review the proposal and share their perspectives with SCAI at [email protected]. Additional information on the comment process, including resources and comment templates, will be provided in the coming weeks.

SCAI remains committed to advocating for policies that support high-quality, patient-centered cardiovascular care while preserving access to TAVR and ensuring appropriate program oversight.

We thank members who have contributed their perspectives throughout this process. Your engagement has been instrumental in shaping SCAI's advocacy efforts and will continue to guide our work during the public comment period.