The Centers for Medicare and Medicaid Services (CMS) has finalized its National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) programs.
There was one key change in the final decision memo, issued Friday, from the proposed memo that CMS published in March: A TAVR institution’s heart team must include one cardiac surgeon who has performed at least 100 open heart surgeries, of which at least 25 are aortic valve-related, and an interventional cardiologist who has performed at least 100 career structural heart disease procedures or at least 30 left-sided structural procedures per year, and has undergone device-specific training as required by the manufacturer. The proposed memo did not include the interventional cardiologist on the heart team of a TAVR institution.
Under the 2012 NCD, aortic stenosis patients had to be evaluated by two cardiac surgeons, and the heart team had to include a cardiovascular surgeon and an interventional cardiologist.
Requirements for hospitals to start a TAVR program remained the same in the final memo as in the proposed NCD. These hospitals must have at least 50 open heart surgeries in the year before TAVR program initiation, at least 300 percutaneous coronary interventions (PCIs) per year, and at least 20 aortic valve-related procedures in the 2 years before program initiation.
For existing TAVR programs, there was no change between the draft and final 2019 NCD. To maintain their TAVR program status, institutions must perform at least 50 AVRs, including at least 20 TAVRs, in the prior year, or at least 100 AVRs, including at least 40 TAVRs, in the prior two years, as well as perform at least 300 PCIs per year.