Where the public stands 2 months from CMS’ decision on TAVR coverage

CMS saw an influx of public commentary after it first published a draft of recommendations for revising the United States’ national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) more than a month ago. Now that the 30-day comment period is over, the agency has a decision to make.

As per its March 26 draft, CMS is proposing a framework that would require TAVR programs to perform at least 50 AVRs (TAVR or surgical AVR) annually or 100 AVRs every two years—including at least 20 TAVRs per year—to maintain qualification for reimbursement services. According to the agency’s public document, programs would also need to log at least 300 percutaneous coronary interventions (PCIs) per year and employ at least one interventional cardiologist and two cardiovascular surgeons.

To qualify for a TAVR program initially, CMS would require hospitals to perform at least 50 open-heart surgeries and 20 aortic valve-related procedures in the year and two years prior to initiating a TAVR program, respectively. Hospitals would also have to staff at least two cardiac surgeons and one interventional cardiologist with extensive experience in structural heart procedures.

CMS’ proposed decision is more flexible than recommendations from four professional cardiology societies, which published a consensus document last August suggesting a threshold of 50 TAVRs and 30 surgical AVRs per year might be a more appropriate gauge of a program’s efficacy. The recommendations are rooted in evidence that higher-volume TAVR centers see better outcomes, but other experts argue the learning curve for TAVR is shrinking as the process improves, elevating outcomes across the board.

In a public comment period that lasted a month, CMS amassed 177 responses from physicians, caregivers and administrators—both positive and negative.

“These new volume thresholds will increase the number of TAVR programs in the United States and will also impact our regional cardiovascular health system as we will most probably add more TAVR programs,” wrote Michael Acker, MD, on behalf of Penn Medicine Heart and Vascular Center physicians. “We also recognize that most of these new programs will be lower-volume sites and we would encourage CMS to prescribe robust quality measures for TAVR in the U.S. We will certainly use these quality benchmarks in assessing our own system TAVR programs.”

Abbott, a major medical manufacturer that has been pushing TAVR technology for years, voiced support for CMS’ proposed changes to the NCD, especially the agency’s suggestion to reduce the requirement for reviewing a patient’s eligibility for AVR from two cardiac surgeons to one. The company made two suggestions to CMS for improving its proposal: work with stakeholders to establish validated shared decision-making tools and continue to explore the development of validated quality metrics.

Under the new proposed decision, CMS would require TAVR programs to participate in a national registry that tracks patients, operators and facilities for outcomes ranging from transient ischemic attacks to quality of life—something the agency said would further its effort to collect more information other than volume to assess a program’s quality and safety.

“I am just so disappointed that everything is seeming still volume-based for doctors and hospitals,” Lawrence Haffner, a self-proclaimed heart valve patient himself, wrote in a public comment. “This should NOT be about volume, but rather should be about quality of care and success. As the years go by and TAVR becomes more widespread in use, the whole volume issue becomes increasingly moot.”

Haffner argued that if hospitals are worried about keeping up their program approval numbers, they’ll perform TAVR even when it’s not the most appropriate treatment.

“Please don’t be so short-sighted when changing the NCD that you make only minor tweaks rather than opening up the possibilities of TAVR to so many other patients who are struggling with aortic stenosis,” he wrote.

In a joint comment, the Society of Thoracic Surgeons, American College of Cardiology, American Association for Thoracic Surgery and Society for Cardiovascular Angiography & Interventions expressed a similar sentiment, saying that if CMS doesn’t revise volume requirements, “it should move expeditiously toward a system where outcome measures replace volume requirements.”

The groups suggested public reporting of procedure volume and at least one significant outcome measure, like 30-day mortality rates, should be mandatory.

Other major players in the space, including Medtronic, Boston Scientific and Edwards Lifesciences, voiced their support of CMS’ proposed changes, and a host of physicians at top-tier universities and health systems said they were in agreement with the majority of the proposal, too.

CMS is expected to make a final decision on the NCD within 60 days of the comment period closing, meaning the agency should issue an announcement by the end of June.