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 and meet other criteria.

This proposed NCD illustrates the significant influence professional societies have on Medicare coverage decisions. Similar to the 2012 Transcatheter Aortic Valve Replacement (TAVR) NCD, CMS largely adopted the Societies’ (The Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the American Association for Thoracic Surgery (AATS)) recommended coverage parameters in drafting its decision. In addition to requiring CED as recommended by the Societies in their NCD request letter, CMS leveraged the facility and operator criteria recently released by the same professional societies.

The proposed decision is also consistent with expectations. Stakeholders anticipated that Medicare would propose CED for TMVR and follow a similar course as TAVR. In its comment letter to CMS on the opening of this NCD, Abbott – the manufacturer of the only FDA-approved TMVR device (MitraClip) – supported the Societies’ request for CED.

In addition, CMS’ requirement that non-FDA approved uses of TMVR only be covered in a randomized clinical trial is likely to be a point of contention in the current comment period. Like TAVR, CMS proposed to centralize its coverage of clinical trials for non-FDA approved uses of TMVR. The randomized trial requirement represents a high evidentiary threshold that will likely be a concern of manufacturers, providers, and patients, as it would preclude potential Medicare coverage of observational studies. Although they are different devices, CMS did not require that non-FDA approved uses of TAVR be in randomized trials to be eligible for coverage.

CMS is soliciting public comments on the proposed decision memo until June 14. The Agency specifically noted its preference for evidence-based comments on the proposed operator and facility criteria. The final NCD is expected by Aug. 13.

View CMS’ proposed decision memo.