The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.
In the revised National Coverage(NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years ( ).
That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.
The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.
In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”
Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.
An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.
“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.