Transcatheter aortic valve replacement (TAVR) is a technology for use in treating aortic stenosis. A bioprosthetic valve is inserted via transfemoral, transapical or transaortic approaches using a catheter and implanted in the opening of the native aortic valve or in failed surgical bioprosthetic aortic valves.
Section 20.32 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for TAVR. In 2012, the Centers for Medicare & Medicaid Services (CMS) established coverage of TAVR under Coverage with Evidence Development (CED). For TAVR procedures used to treat symptomatic aortic valve stenosis when furnished according to Food and Drug Administration (FDA)-approved indications, the NCD contains requirements including specific procedural volume requirements for heart teams and hospitals as well as mandatory participation in a prospective, national, audited registry.
The NCD requires TAVR procedures for uses that are not expressly listed as an FDA-approved indication to be performed in clinical studies that meet requirements set forth in the NCD and are approved by CMS.
On July 25, 2018, CMS is convening a panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Through this meeting we are seeking the MEDCAC's recommendations regarding the evidence on procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. For more information see: https://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=75.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.