Thank You, CMS, for Proposing Broader Medicare Access to TAVR

The following is a statement from Sue Peschin, MHS, President and CEO of the Alliance for Aging Research regarding the Centers for Medicare and Medicaid Services’ (CMS) newly released proposed National Coverage Determination (NCD) update for Transcatheter Aortic Valve Replacement (TAVR).

The proposed updates to Medicare’s national TAVR coverage policy represent a transformative milestone for heart-valve disease patients and their families. The TAVR procedure is often preferred by patients with severe aortic stenosis (AS) because it avoids open-heart surgery and allows quicker treatment and recovery. By lifting the 14-year coverage with evidence development (CED) requirement, CMS is formally recognizing that TAVR is reasonable and necessary for the treatment of severe, symptomatic aortic stenosis (AS).   

In addition, updates to the TAVR coverage criteria related to pre-procedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements shift the focus to where it matters most: TAVR proficiency, data-driven quality, patient experience, and relevant operator expertise. We urge CMS to maintain this momentum and finalize these pivotal changes to transform cardiovascular care delivery.

Key Advancements We Applaud in the Draft Policy

• Reduced Patient Burden: Shifting initial evaluations to a heart team medical records review and requiring only one in-person visit with a TAVR operator will provide immense relief to patients and their families.
• Modernized Quality Metrics: Shifting hospital requirements toward continuous quality improvement processes ensures that patient outcomes dictate success.
• Expanded Health Access: Allowing single-operators where appropriate and prioritizing procedural proficiency over rigid structural volume requirements—including eliminating annual quotas for unrelated cardiac procedures—safeguards quality while broadening hospital participation in historically underserved communities.
• CMS Data Sharing: Requiring clinical study sponsors/investigators to regularly share data with CMS and the public will better inform future coverage policy.
• Future-Proof Pathways: Utilizing Medicare Administrative Contractor (MAC) coverage discretion to accommodate future clinical indications creates a vital coverage framework without undergoing the lengthy NCD reopening process.

The Alliance looks forward to collaborating and mobilizing with our partner patient advocacy groups on unified support for these changes in public comments. Patients can submit their own comments to CMS by July 15.

This decision represents an important step toward Medicare ensuring that patients receive timely access to the treatments that they and their physicians determine are most appropriate for them. We applaud and thank CMS for this forward-thinking proposal and strongly encourage the agency to finalize this draft NCD with these patient-centered updates in mid-September.

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To speak with a member of the Alliance team on this issue, email Katie Riley, Vice President of Communications, at [email protected].