The final decision is largely consistent with their proposed decision from May, with the exception of some additional operator and facility requirements. CMS specified that they will cover TMVR under its Coverage with Evidence Development (CED) program. Patients receiving TMVR for an FDA-approved indication must: 1) be treated by operators and within facilities meeting strict criteria and, 2) be enrolled in a CMS-approved registry. For non-FDA approved uses, TMVR must be provided in an FDA- and CMS-approved randomized clinical trial (RCT) and meet other criteria.
CMS received 83 comments on the proposed decision; over half were from medical centers. The majority of commenters supported the proposed decision with the exception of the requirement that non-FDA approved uses of TMVR only be eligible for coverage if provided in an approved RCT. Commenters requested that CMS delete this stringent trial design requirement. However, CMS maintained the requirement, stating that RCT evidence is necessary, given that the FDA advisory panel on MitraClip® (the only FDA-approved TMVR device) noted a lack of evidence on long-term effectiveness and expressed concern over the high rate (20.4%) of transcatheter repair failures in the first year.
Of note, this NCD governs Medicare coverage of FDA-approved Category A and B investigational device exemption (IDE) trials for TMVR. To be eligible for Medicare coverage, IDE trial sponsors must meet the parameters outlined for non-FDA approved uses of TMVR and submit their trials to the Coverage and Analysis Group (CAG) for review and approval.
CMS’ decision is effective immediately and binding on all local Medicare contractors. Trial sponsors with FDA-approved RCTs for TMVR that are seeking Medicare coverage and meet the NCD’s criteria can submit their studies for CAG’s review at any time. The information will be reviewed, and approved studies will be identified on the CMS website.
View the final NCD.