Although applauded by the clinical and device communities for covering treatment of functional mitral regurgitation, a new CMS proposed decision memo for transcatheter edge-to-edge repair of the mitral valve has taken many by surprise for not including a coverage with evidence development policy and for pushing some coverage decisions down to local contractors.
In late June, the Centers for Medicare & Medicaid Services released a long-delayed proposed coverage decision memo for transcatheter mitral valve repair (TMVR). The proposal would clearly be a market boost for Abbott Vascular’s MitraClip device in that it would expand coverage to patients with moderate-to-severe or severe functional mitral regurgitation (FMR) to align with Abbott’s 2019 FDA approval in that expanded population. CMS also proposes to change the name of the coverage policy to transcatheter edge-to-edge repair (TEER) in an effort to “more precisely define the treatment addressed” and avoid confusion with other mitral valve repair or replacement therapies.
But the latest proposal also includes some elements that are giving practitioners in the TMVR space pause. In stark contrast to past policy decisions related totranscatheter aortic valve repair (TAVR) devices, in 2012, and TMVR for degenerative/primary MR in 2014, CMS’ proposal doesn’t include any coverage with evidence development (CED) requirements. The agency’s 2014-established policy for TMVR requires beneficiaries with degenerative/primary MR treated with MitraClip to be entered into a registry. It also covers treatment of FMR in the context of an FDA randomized trial. The new proposal would cover TEER for FMR when conducted in a hospital that meets specific experience and personnel requirements, but it includes no registry requirement. And for the degenerative/primary indication, it not only removes the registry requirement, but it takes away the national coverage decision (NCD) outright, leaving coverage up to local Medicare Administrative Contractor (MAC) discretion. Providers would no longer be required to participate in a registry or to participate in a clinical study to furnish this heart procedure to Medicare patients.