On Feb. 18, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that a decision on a National Coverage Determination (NCD) to cover transcatheter mitral valve repair (TMVR) for the treatment of significant symptomatic functional mitral regurgitation (MR) would be forthcoming. CMS had been expected to announce its initial decisions about coverage of TMVR for functional MR on Feb. 14, 2020. Typically, once the agency has formally accepted a request to open a National Coverage Analysis (NCA) for a technology, there is a 30-day public comment period for interested parties to express support for or concerns with the proposal. CMS uses this input in its decision about whether to grant an NCD.
In a September 2019 comment, Heart Valve Voice US was strongly supportive of extending Medicare coverage to TMVR for the treatment of functional MR while also noting its concerns with CMS’ continued use of volume requirements as a proxy for quality over patient outcomes. Heart Valve Voice US also noted the importance of the acceptance of telehealth as a facet of treating MR given medicine’s progression away from face-to-face visits between a patient and his or her care team. We also supported a move away from randomized controlled trials for non-FDA approved conditions given the burden of randomization in this and other NCD contexts.
The forthcoming NCD follows an original decision issued by CMS on Nov. 7, 2014 to cover TMVR under Coverage with Evidence Determination (CED) for the treatment of significant symptomatic degenerative mitral regurgitation within an FDA-approved indication. Under this initial decision, CMS could approve coverage for the use of TMVR for treatment of unapproved indications if the treatment is part of a sanctioned clinical trial. This NCD that ultimately provided coverage for the procedure, which focused on Abbott Vascular’s MitraClip as the only FDA-approved device for the procedure, was triggered by a request to CMS from the Society of Thoracic Surgeons (STS), the American College of Cardiology Foundation (ACCF), and others to cover the procedure under Medicare.
Once CMS officially releases its proposed coverage determination, the public will have until 90 days after the NCD publication to submit comments prior to the close of the NCA process.