Edwards Comments on CMS Proposed TAVR NCD Policy Updates

July 15, 2026 
Submitted electronically to: CAGInquiries@cms.hhs.gov 
Centers for Medicare & Medicaid Services (CMS) 
Coverage and Analysis Group (CAG) 
7500 Security Boulevard 
Baltimore, MD 21244 

Ms. Joanna Baldwin & Ms. Meredith Loveless, 

Edwards Lifesciences commends CMS for its proposed modernization of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). The draft policy reflects careful consideration of contemporary evidence, the evolving needs of Medicare beneficiaries with aortic stenosis (AS), and stakeholder feedback. Edwards supports CMS’ efforts to modernize this policy that advances timely access for Medicare beneficiaries to appropriate treatment while preserving the quality safeguards for patients that have enabled TAVR to become one of the most rigorously studied and successful innovations in cardiovascular care. 

Edwards urges CMS to finalize many of the proposed policy updates and also respectfully offers several recommendations, as summarized below. Detailed rationale, supporting evidence, and specific policy recommendations are provided in our full comments. 

• Finalize coverage of TAVR for symptomatic severe AS without CED 

• Finalize coverage of TAVR for asymptomatic severe AS under § 1862(a)(1)(A) 

• Finalize the Heart Team as the foundation of high-quality aortic stenosis care, while allowing flexible patient evaluation and the ability to determine the TAVR operator approach based on patient needs, preserving joint participation when appropriate 

• Finalize removal of hospital volume thresholds while maintaining facility infrastructure, physician proficiency, and continuous quality improvement requirements 

• Clarify that emergency TAVR is exempt from pre-procedure evaluation requirements that may be intended for elective procedures 

• Cover moderate AS under § 1862(a)(1)(E) 

The success of TAVR in the United States has been a shared achievement of many acting in the best interest of patients – reflecting contributions of CMS, FDA, specialty societies, the multidisciplinary Heart Team, hospitals, industry partners, and patients themselves. The Heart Team, inclusive of both cardiac surgery and interventional cardiology, has been foundational to this progress. The proposed modernization is an opportunity to build on this shared foundation by preserving the Heart Team’s central role in multidisciplinary shared decision-making while allowing programs the operational flexibility to determine the most appropriate evaluation pathway, procedural staffing model, and care-delivery workflow based on patient needs. In doing so, CMS can preserve the quality infrastructure these stakeholders jointly established while helping more Medicare beneficiaries receive timely, appropriate care. 

Edwards appreciates CMS' leadership and its continued commitment to evidence-based, patient-centered coverage policy. If the experience of the past 15 years is a guide, a thoughtfully modernized NCD can preserve accountability and quality while reducing unnecessary barriers to care – allowing more patients with AS to benefit from timely treatment in the care of a Heart Team. Edwards looks forward to continuing this shared progress and thanks you for your consideration of our comments.