In response to the draft national coverage determination (NCD) issued by the Centers for Medicare and Medicaid Services (CMS) last month, the ACC worked with peer stakeholder groups – the Society for Cardiovascular Angiography and Interventions (SCAI), Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) – to submit formal comments on the proposal.

The societies support changes proposed by CMS to eliminate a requirement for a second pre-procedure consultation and the continued collection of data to answer outstanding questions. However, the societies also reiterate the importance of a minimum volume standard as a surrogate to ensure high-quality outcomes. This aligns with the 2018 AATS/ACC/SCAI/STS Expert Consensus Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement and recently published TVT Registry data.

Should CMS not make changes to the volume section of the proposal, the societies recommend CMS require public reporting of outcome measures as a check on quality. The societies also note a role for external certification in supporting any sites continuous quality improvement, but especially as a mechanism to support underperforming sites. CMS will issue its final NCD by June 24.

Keywords: ACC Advocacy, Transcatheter Aortic Valve Replacement, Quality Improvement, Centers for Medicare and Medicaid Services, U.S., Medicaid, Heart Valve Prosthesis, Certification, Registries, Referral and Consultation, Outcome Assessment, Health Care, Medicare

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