CMS Taking Another Look at Volume Requirements for TAVR Programs

The US Centers for Medicare & Medicaid Services (CMS) has started a review of its national coverage determination (NCD) for TAVR, with the purpose of reevaluating whether procedural volume requirements for starting and maintaining TAVR programs are supported by the evidence.

CMS announced its national coverage analysis yesterday and called for relevant public comments, which will be collected through July 27. The analysis has an expected completion date of June 25, 2019, and in the meantime, CMS will consider recommendations that come out of a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) later this summer.

“The MEDCAC panel will assess whether scientific evidence supports requiring hospitals and heart team members to meet prespecified volume requirements for these procedures in order to begin and maintain TAVR programs” and “explore the challenges and potential unintended consequences that may result” from the requirements, according to a CMS announcement.

The original NCD for TAVR, which was released in 2012, established requirements for coverage that included minimum volumes of surgical aortic valve replacements, catheterizations, and PCIs that hospitals and heart teams had to meet in order to begin and maintain TAVR programs.

But debate continues about whether those standards are relevant in current practice. At the Structural Heart Disease Summit held last week in Chicago, IL, physicians wrangled with the issue, with many arguing that focusing on volume alone is not the best way to assess the quality of TAVR programs. One physician estimated that if current volume requirements are increased to levels proposed last summer by the American Association for Thoracic Surgery (AATS), American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Thoracic Surgeons (STS), nearly 40% of TAVR centers would no longer qualify.

The draft consensus statement from those societies suggested minimums of 50 TAVR procedures per year (or 100 within the last 2 years) and 40 surgical AVRs per year (or 80 within the last 2 years. Those figures are up from minimums that were recommended in the previous multisociety consensus document published in March 2012.

And it looks like CMS is willing to revisit its own requirements after being prompted by a formal request from three physicians, who are asking the agency to either retire the current NCD or remove the volume requirements.

“TAVR is no longer a new, experimental, and risky procedure,” Peter Pelikan, MD (Providence Saint John’s Health Center, Santa Monica, CA), Richard Wright, MD (Pacific Heart Institute, Santa Monica, CA), and John Robertson, MD (Providence Saint John’s Health Center), wrote to CMS last October. “The non-TAVR volume criteria in the NCD are not supported by evidence-based research, and are restrictive for any high-quality but not high-volume cardiovascular program. Now that the procedure is streamlined, with excellent outcomes, CMS approval and reimbursement should be based on quality and not non-TAVR procedure volume surrogates for quality.”