STS News, Fall 2018 -- The Centers for Medicare & Medicaid Services is reevaluating the scientific evidence supporting volume requirements for hospitals and heart team members who perform transcatheter aortic valve replacement (TAVR) procedures.
The current TAVR National Coverage Determination (NCD), which was released in 2012, requires that hospital programs and heart team members perform a certain number of surgical aortic valve replacements and percutaneous coronary interventions in order to begin or maintain a TAVR program.
On July 25, a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel met in Washington, DC, to hear recommendations regarding procedural volume requirements. Among the presenters were Joseph E. Bavaria, MD, David M. Shahian, MD, and Thoralf M. Sundt, MD. During the presentation, Dr. Bavaria stressed that programmatic TAVR volume requirements are essential: “Quality cannot be reliably determined at low-volume centers—good or bad. That is the conundrum.”
The MEDCAC panel will now advise CMS as the agency prepares a new TAVR NCD due for release in June 2019. In addition, CMS will consider written comments, including those in a joint letter from STS, the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI).
Prior to the MEDCAC meeting, the four societies published an expert consensus document on TAVR in each of their respective peer-reviewed journals, including The Annals of Thoracic Surgery. The writing committee for the “2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement” was co-chaired by Dr. Bavaria and Carl L. Tommaso, MD. The document updates a 2012 version and identifies criteria for performing TAVR procedures safely, while optimizing patient outcomes. A related editorial, “TAVR 2.0: Collaborating to Measure, Assure, and Advance Quality,” by Dr. Shahian and colleagues, also was published in The Annals.
Read the multisociety comment letter, the expert consensus document, the editorial, and slide decks from the MEDCAC meeting below.
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