The Centers for Medicare & Medicaid Services (CMS) is proposing to cover transcatheter mitral valve repair, but only if certain conditions are met.
In October 2013, the FDA approved Abbott’s MitraClip as a treatment for patients with mitral regurgitation who are considered too high risk for mitral valve surgery, making it the first and currently the only minimally invasive device available in the U.S. Approval was based on results from the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) series of studies and the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System) Registry.
The Society of Thoracic Surgeons, the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions and the American Association for Thoracic Surgery teamed up in an effort to encourage CMS to cover transcatheter mitral valve procedures for approved devices. The societies recommended development of regional heart valve referral centers of excellence, participation in the Transcatheter Valve Therapies registry, training and credentialing and guidelines. They also called for more studies assessing other devices in an expanded patient population.
In its proposal, CMS supported reimbursement for transcatheter mitral valve repair under the approved indication and for approved randomized clinical trials. It outlined conditions similar to those for transcatheter aortic valve replacement, including use of a heart team, registry participation and infrastructure and volume requirements.
“We believe that there is promising but inconclusive evidence whether TMVR [transcatheter mitral valve repair] improves health outcomes for a defined subset of the Medicare population,” CMS wrote in a May 15 memo outlining its proposal for national coverage under Coverage with Evidence Development. “Therefore, we conclude at this time that TMVR as a treatment for MR [mitral regurgitation] has promising evidence of improved health outcomes only for Medicare beneficiaries with significant symptomatic MR and only if it is furnished under conditions that maximize the beneficiary’s chances for successful treatment.”
CMS may make its final decision by mid-August.