Today, the Alliance submitted public comment urging CMS to modernize the TAVR National Coverage Determination by removing Coverage with Evidence Development (CED) and expanding national coverage to all FDA-approved indications for both symptomatic and asymptomatic aortic stenosis.

The letter emphasizes that TAVR has been the established standard of care since 2017, with more than a decade of robust clinical trial and real-world evidence demonstrating its safety, effectiveness, and benefits for patients.

The comment argues that continued reliance on CED is outdated, lacks clear statutory authority, and functions as restrictive utilization management that limits access for older adults, rural and community-based patients, and anyone who may rely on TAVR that is unable to access a registry or study.

This CED has been in place for far too long, restricting and blocking access in the name of evidence generation. CMS should retire CED entirely for TAVR and provide clear, consistent national coverage to ensure equitable access for all Medicare beneficiaries.

Read the full letter.