The Centers for Medicare and Medicaid Services (CMS) has released the final national coverage determination (NCD) that will govern TAVR services to Medicare patients. The final policy is largely consistent with the draft NCD issued in March.

The final 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 final NCD, coverage would be contingent on:

• 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 intraoperative technical aspects of the procedure
• 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 on the draft NCD that certain criteria to establish and maintain TAVR programs are necessary to optimize quality outcomes and patient safety, though CMS chose not to implement those exact recommendations.

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.

The coverage parameters of the NCD are effective immediately. However, it takes CMS several months to create claims processing instructions that Medicare Administrative Contractors (MAC) use to update their software.

The ACC also recently launched its new Transcatheter Valve Certification, an external review and certification process that will guide hospitals in meeting standards for multidisciplinary teams, formalized training, shared decision-making and registry performance.

"The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data."

"With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC's Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers," says ACC President Richard J. Kovacs, MD, FACC.

Keywords: ACC Publications, Cardiology Magazine, Health Policy, Transcatheter Aortic Valve Replacement, Aortic Valve, Patient Safety, Centers for Medicare and Medicaid Services, U.S., United States Food and Drug Administration, Medicaid, Medicare, Registries, Heart Valve Prosthesis, Surgeons, Certification, Patient Care Team, Software

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