CMS on Friday finalized requirements that relax the number of procedures providers must perform to receive Medicare and Medicaid reimbursement for transcatheter aortic valve replacements (TAVR).
TAVR currently is FDA-approved for aortic valve replacement among patients who cannot have open-heart surgery or patients for whom open-heart surgery is considered risky, but recent research has suggested the procedure could also be more effective than open-heart surgery for low-risk patients.
CMS first approved TAVR for reimbursement in 2012. In the past, CMS has required that doctors and hospitals perform at least 50 open-heart valve repairs, 400 angioplasties, and at least 1,000 cardiac catheterizations per year to receive Medicare or Medicaid reimbursement for TAVRs. Medicare policy also requires that two cardiac surgeons individually examine patients to determine their eligibility for TAVR.
As a result, only about half of the roughly 1,100 U.S. hospitals providing surgical valve replacement can perform TAVR.
In response to criticism that the existing reimbursement requirements are outdated, CMS in March released a proposal that would make it easier for providers to meet surgical volume requirements for TAVR reimbursement.
CMS on Friday finalized the proposed volume requirements, Inside Health Policy reports.
Under the finalized policy, hospitals without an existing TAVR program will have had to perform at least 50 open heart surgeries in the year before the program starts and at least 20 aortic valve-related procedures over the past two years.
As far as staffing requirements, hospitals that plan to start a TAVR program must have a cardiovascular surgeon who has performed at least 100 career open heart surgeries, including at least 25 that were aortic valve related. In addition, the team must have an interventional cardiologist with at least 100 career structural heart disease procedures or at least 30 left-sided structural procedures per year and device-specific training required by the manufacturer.
To maintain existing TAVR programs, hospitals will need to perform at least 50 aortic valve replacements—including at least 20 TAVR procedures—every year or at least 100 aortic valve replacements—including at least 40 TAVR procedures—every two years.
In addition, all hospitals, including those with new or existing programs, must have two or more doctors with cardiac surgery privileges and one or more physician with interventional cardiology privileges, and perform at least 300 percutaneous coronary interventions per year.
CMS in a release said the finalized policy "reflects the current evidence base" regarding TAVR-specific outcomes "and strikes an appropriate balance between ensuring that hospitals have the experience and capabilities to handle complex heart disease cases while limiting the burden and barriers that excessive requirements create for hospitals and patients."
The agency added that it will continue to monitor TAVR outcome measures and "encourage continued progress toward the establishment of such widely-supported measures as potential replacements for procedural volume criteria."
Edwards Lifesciences, manufacturer of the Sapien line of TAVR valves, in a statement said it was "encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume," adding that the move "could reasonably coincide in the future with discontinuation of Coverage with Evidence Development" (Stein, Inside Health Policy, 6/21 [subscription required]; Lou, MedPage Today, 6/24; CMS memo, accessed 6/25).
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