CMS Panel Takes First Look at Volume Requirements for TAVR Centers

Patrice Wendling

July 26, 2018

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) took a tepid step toward keeping and/or possibly discarding procedural volume requirements for new and continuing transcatheter aortic valve replacement (TAVR) programs and operators.

After hearing hours of data that elicited starkly different conclusions about procedural volume and quality, the panel's votes fell squarely in the middle on nine key questions regarding surgical aortic valve replacement (SAVR), TAVR, and percutaneous coronary intervention (PCI) volume requirements.

Panelists were not asked to provide fixed procedural volumes but to rate their confidence levels from 1 to 5, with 5 being highly confident.

For hospitals without TAVR experience starting a new TAVR program, the voting member average rating was:

  • 3.78 that there is sufficient evidence that a specific threshold of SAVR procedural volumes must be required;

  • 3.44 that sufficient evidence that a specific threshold of PCI procedural volume must be required;

  • 3.11 that the benefits of meeting SAVR or PCI procedural volume requirements to start a new TAVR program outweigh the harms of limiting access to TAVR to only hospitals meeting volume requirements.

Regarding hospital requirements for experienced TAVR hospitals to maintain its TAVR program, the average rating was:

  • 3.56 that there is sufficient evidence for a SAVR procedural volume requirement;

  • 3.33 that there is sufficient evidence for a PCI procedural volume requirement;

  • 3.67 that the benefits of meeting procedural volume requirements to maintain a TAVR program outweigh the harms of limiting access to TAVR only to hospitals meeting volume requirements.

On the issue of operator requirements to begin a TAVR program, the panel's average rating was:

  • 4.33 that there is sufficient evidence that a certain threshold of either SAVR or TAVR procedural volumes must be required for the principle cardiovascular surgeon on a TAVR heart team;

  • 4.22 that there is sufficient evidence that a certain threshold of structural heart disease procedural volume be required for the principal interventional cardiologist on a TAVR heart team.

Finally, regarding the question of TAVR heart team requirements to maintain a TAVR program, the average rating was:

  • 3.33, 4.11, and 3.78 that the evidence is sufficient to require a certain threshold of TAVR procedural volumes for the team's principal cardiovascular surgeon, principal interventional cardiologist, and the combined experience of the principal cardiovascular surgeon and interventional cardiologist, respectively.

The MEDCAC's vote is just the first step in the Centers for Medicare and Medicaid's (CMS) review of the current national coverage determination (NCD) for TAVR.

During the hearing, Peter Pelikan, MD, Providence Saint John's Health Center, Santa Monica, California, said the time is right to change the NCD and that evidence suggests only a weak correlation between PCI operator volume and quality.

He took issue with the requirement that two surgeons must sign off before a TAVR procedure will be covered by CMS as well as a multisociety updated TAVR consensus document released last week that shifts the focus of TAVR program performance to the quality of patient outcomes but retains procedural volume requirements.

"Quality — not volume — should determine program initiation and maintenance," Pelikan said. "Operator training, experience, and skill should be the most determinant of program quality and outcome, whether it be for the interventional cardiologist or heart surgeon skilled in structural heart therapy and alternative nontransfemoral access."

Several other speakers, however, questioned the difficulty of directly measuring quality of care, particularly in low-volume centers with few events.

Past president of the Society of Thoracic Surgeons (STS), Joseph E. Bavaria, MD, University of Pennsylvania, Philadelphia, who co-chaired the writing committee for the consensus document, presented new data from the STS/American College of Cardiology Transcatheter Valve Therapy registry strongly suggesting that absolute 30-day mortality is worse at low-volume sites below a 50-annual TAVR threshold.

"Death is death without statistical uncertainty," he said. "Uncertainty of the quality of care is problematic. We want a healthcare system structure and policies that provide greater, not less, certainty as patients, families, and clinicians make treatment decisions."

Bavaria said these concerning signals for worse low-volume outcomes occurred under the volume thresholds currently in place. They are buried in the overall improving results for TAVR because the sites doing more than 50 TAVR cases/year account for 84% of all cases in the United States, he said.

"Reducing these thresholds would be expected to create a large increase in the number of low-volume sites, potentially decreasing volumes at existing sites and thus potentially shifting the overall outcomes in the United States towards low-volume sites and away from much better results of the higher-volume sites," Bavaria said.

Under its current NCD, implemented in 2012, CMS requires that to begin a TAVR program, hospitals without TAVR experience must have at least 50 AVRs in the previous year prior to TAVR, including high-risk patients; at least two physicians with cardiac surgery privileges; and at least 1000 catheterizations/year, including at least 400 PCIs/year.

Martin B. Leon, MD, New York-Presbyterian/Columbia University Medical Center, New York, said the recent consensus document "doesn't go far enough" and that to improve access to all therapies and achieve optimal clinical outcomes for all aortic stenosis patients "clearly, quality metrics should supersede arbitrary volume thresholds as a general principle."

He added, "We feel that surgery volumes can in fact be eliminated as criteria for new and existing TAVR centers and they should be replaced by a quality metric, such as having and maintaining a 2-star rating defined by the STS."

The MEDCAC panel also discussed at length whether volume thresholds create or contribute to disparities in access to TAVR, particularly among minorities, women, and low-income patients.

Association of Black Cardiologists board member, Aaron Horne Jr, MD, MBA, with the Cardiac & Vascular Interventional Group in Dallas, Texas, said a 50 TAVR and 30 SAVR annual volume requirement would negatively increase wait times for TAVR and only heighten socioeconomic and racial disparities.

Although blacks benefit equally from TAVR as whites, he noted that penetration of TAVR is only 3.8% in the black community. At the same time, he said it has to be acknowledged that a disproportionate proportion of blacks decline AVR and that the reasons are multifactorial, including distance to care, education, and lower rates of referral to cardiology.

"Shared decision-making is not optimal" and "limiting patient access through arbitrary procedure-specific quotas will create unintended barriers," Horne Jr said.

Ted Feldman, MD, NorthShore University Health System, Evanston, Illinois, also emphasized the value of medical professionalism among physicians and education of patients and physicians to maximize patient care. He agreed that the barriers to access are complex and multifactorial, noting for example, that the rate of TAVR per Medicare population is significantly higher in Wyoming, which has no TAVR sites, than in his home state of Illinois, with 19 TAVR sites.

"It's very hard when you see those data to argue that adding sites in Illinois is going to improve the access to care, rather than working hard to educate patients and physicians regarding this disease," he said.

"The idea that access and more sites are equivalent has been a big part of the discussion up until now and there is absolutely nothing to suggest that those two things are equated with one another."

Disclosures for the speakers and panelists are available on the CMS website.

Centers for Medicare & Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Transcatheter Aortic Valve Replacement (TAVR) meeting. Baltimore, Maryland; July 25, 2018.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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