The minimum experience that interventional cardiologists and surgeons would need to have to participate in a Medicare-covered transcatheter aortic valve replacement program under a proposal issued last month has many physicians worried that access to the promising new procedure could be overly restricted.
But the credentialing requirements in national coverage proposal by the Centers for Medicare and Medicaid Services, released Feb. 2, are based on guidance from the main professional medical societies representing practitioners who will be performing the procedure, recently available in the United States because of the November 2011 approval of the Edwards Lifesciences’ Sapien valve by the Food and Drug Administration. And those professional groups – the American College of Cardiology, the Society of Thoracic Surgeons, the American Association of Thoracic Surgery, and the Society for Cardiovascular Angiography and Interventions – issued a consensus document last week laying out, in some cases, even stricter medical center and operator requirements than does the CMS.
The ACC, however, has already independently proposed some revisions to the consensus document, based on the complaints from individual practitioners.
Under its proposal, the CMS would cover transcatheter aortic valve replacement (TAVR) for FDA-approved indications in the context of specific credentialing mandates, and with the requirement that patient data are entered into a registry.
Realistic Structural Heart Caseload?
The primary credentialing matter that raised alarm, particularly among interventional cardiologists, was the experience requirements for "structural heart disease procedures," the category into which the TAVR procedure falls.
The CMS’s coverage proposal would require that an interventional cardiologist participating in a TAVR program have "professional experience" with 50 such procedures. But many clinicians who commented on the proposal to the CMS before its March 3 deadline worried that otherwise highly qualified doctors and centers will not be able to meet this high – and, some say, arbitrary – threshold.
"We do not believe that this criterion has good discriminating ability to identify interventionalists [who will] be able to perform TAVR safely and successfully," noted Dr. Mudassar Ahmed, director of the cardiac catheterization laboratory at Essentia Health–St. Mary’s Medical Center, Duluth, Minn., on March 2 in a typical comment.
"Furthermore, given the dearth of approved devices to treat structural heart diseases, it is likely that many centers renowned for their interventional expertise will be excluded from coverage, and therefore not be able to serve the needs of patients that would truly benefit from TAVR."
Other physicians pointed out that there is a range of different types of structural heart procedures, several of which are not particularly relevant on a technical basis to the TAVR procedure.
Dr. Yele Aluko, medical director of cardiac catheterization at the Presbyterian Cardiovascular Institute in Charlotte, N.C., argued that only balloon aortic valvuloplasty "is pertinent to TAVR." But, he noted, very few interventional cardiologists perform balloon aortic valvuloplasty in clinical practice, and it is rare for fellows to gain experience with the procedure before becoming attending cardiologists.
Some who commented to the CMS argued that the agency should lower the volume threshold for the procedures; others suggested loosened requirements or exemptions in some cases to expand geographical access to the procedure and to give new clinicians a pathway to gaining experience with TAVR.
Meanwhile, the multisociety consensus document – which emphasizes a new "heart team" approach among surgeons, cardiologists and others, and lays out appropriate prerequisites for operators and medical centers for a TAVR program – puts the minimum number of structural heart procedures for an interventionalist at an even higher threshold: 100 lifetime procedures, or 30 left-sided structural procedures per year. The societies specify that 60% of the procedures should be balloon aortic valvuloplasty, and they list other qualifying surgeries.
But the criticisms from the interventional cardiology community already have had an impact. The ACC reviewed the critiques sent to the CMS by individual clinicians before filing its March 3 comments, and included some revised recommendations in response.
"We have reviewed the comments submitted to CMS to date, and we are concerned that strict adherence to the TAVR interventional program and interventional cardiologist requirements in Table 1 [of the consensus document] could significantly limit patient access in the current environment," ACC President David Holmes wrote.
The ACC now says that the requirement should be 50 lifetime structural procedures or 20 per year for the entire interventional cardiology TAVR team, rather than an individual operator. But, in conjunction, the ACC also suggests revising its institutionwide interventional volume requirements to include 30 or more structural procedures, as part of the thresholds of 1,000 catheterizations and 400 percutaneous coronary interventions per year that are currently in the consensus statement. This is stricter than the 400 catheterizations and 150 PCIs (including 15 or more structural procedures) that are required per year under the CMS’s proposal.