Today, the Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to seek the MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs. The meeting specifically focused on appraisal of the state of evidence for surgical aortic valve replacement (SAVR), TAVR, percutaneous coronary intervention (PCI) and other relevant structural heart disease procedural volume requirements.
In May 2012, CMS finalized a national coverage determination (NCD) for TAVR that established specific requirements for coverage, including procedural volume requirements hospitals must meet to begin and maintain TAVR programs.
Recognizing that CMS was moving ahead and furthering discussions of TAVR requirements, SCAI leadership, after careful consideration and discussion, decided it was our best option to actively participate in the public discussion, using the most comprehensive TAVR data available. Our membership expects nothing less than for SCAI to be at the table for future focused discussions which may impact our members and their TAVR centers.
Therefore, SCAI joined with the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) to develop a comprehensive presentation to address the panel's interest in these updated requirements.
During today’s presentation, Ted Feldman, MD, MSCAI, represented SCAI and expressed the importance of a focus on patient-centered care for aortic valve disease (AVD) through consideration of the patient experience and pathway to care.
Prior to the meeting, SCAI joined with the aforementioned organizations to develop and commission a multi-societal consensus document on current operator and institutional recommendations and requirements for TAVR. The purpose of the document was to identify the appropriate criteria for performing these procedures that would serve as a guide for both practitioners and institutions in the development and maintenance of TAVR programs, with a goal of optimizing quality outcomes.
As TAVR technology evolved, it became apparent that there was a substantial need to update the first multi-societal document published in 2012 and provide a new and updated framework for centers in the U.S. providing TAVR as a treatment option for patients with aortic valve disease (AVD). With TAVR outcomes data now available, the writing committee sought to promote standards that would help centers, focusing on three key areas which include: 1) an emphasis on direct measures of quality of care; 2) care of all patients with aortic valve disease; and 3) the incorporation of shared decision making (SDM).
SCAI’s mission is to lead the global interventional community through education, advocacy, research and quality patient care. In this updated document, sites are recommended to incorporate methods and processes that promote patient and family-centered care with informed SDM.
TAVR is the preferred choice for high or intermediate risk patients with AVD, and over time we predict that it may become the procedure of choice for low-risk patients. We believe that patients, families, and referring providers need to be appropriately informed about all treatment options for AVD, including TAVR. Therefore SCAI was the driving agent in ensuring that SDM was instituted as a requirement of programs in the U.S.
We strongly believe that careful planning, patient selection, and a knowledgeable and experienced team offer the best chance for superior outcomes for the patient. We support this great technology, and all innovation, and are currently working diligently with both our internal and external stakeholders to ensure that SCAI provides its members and their teams with the education they need, as well as resources for the patients we humbly serve.
David A. Cox, MD, MSCAI
SCAI President, 2018-19