On March 26, the Centers for Medicare and Medicaid Services (CMS) released a draft national coverage determination (NCD) governing its TAVR coverage policy for Medicare fee-for-service patients. The proposed coverage includes some familiar elements from the existing NCD that has been in place since 2012, while also taking new approaches to facilitate access to this therapy.

Under the proposed NCD, coverage would be contingent upon:

• Care of the patient by an interdisciplinary heart team that includes a cardiac surgeon and interventional cardiologist;
• Facility infrastructure and volume standards;
• Interventional cardiologist and cardiac surgeon experience and volume standards;
• Joint interventional cardiologist and cardiac surgeon participation in intra-operative technical aspects of the procedure; and
• Data collection through a national registry to allow continued study of key research questions through the tracking of procedural and post-procedural outcomes.

These coverage criteria incorporate some themes and specifics from the 2018 AATS/ACC/SCAI/STS Expert Consensus Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement. The societies previously commented to CMS that certain criteria to establish and maintain TAVR programs are necessary to optimize quality outcomes and patient safety.

Outcomes after TAVR were superior or as good as those following surgical aortic valve replacement (SAVR) in patients at low surgical risk, according to two trials presented March 17 at ACC.19. Neither the current nor draft NCD would extend TAVR coverage to these patients because the Food and Drug Administration (FDA) has not approved TAVR indications in this patient population. If the FDA expands TAVR approval to include low-risk patients, CMS coverage for this patient population would follow because covered indications are/would be linked to FDA-approved indications.

ACC Advocacy staff are still reviewing the rule and will provide a more detailed overview in the coming days. Additionally, staff and member experts will work together to review the proposed NCD and provide comments to CMS as part of the 30-day public comment period. ACC members can also provide comments through the CMS portal through April 25. CMS will issue its final NCD by June 24.

"The ACC is pleased to see CMS propose updated TAVR coverage criteria that builds on the existing foundation of successful patient care stemming from the 2012 NCD. The draft NCD creates a path for new sites to develop and demonstrate infrastructure necessary to initiate a program and continue providing high-quality care," said ACC President Richard J. Kovacs, MD, FACC.

Keywords: ACC Advocacy, Registries, National Cardiovascular Data Registries, STS/ACC TVT Registry, Technology Assessment, Biomedical, Delivery of Health Care, Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Medicaid, Medicare

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