MitraClip system gets US Medicare National Coverage Determination


The Centers for Medicare & Medicaid Services (CMS) recently issued a National Coverage Determination (NCD) that extends coverage for Medicare beneficiaries in the United States to Transcatheter Mitral Valve Repair with Abbott’s MitraClip system. The MitraClip system is a first-of-its-kind device that provides new hope for people with severe degenerative mitral regurgitation who are not good candidates for surgery. Treatment with MitraClip can significantly improve symptoms and quality of life by reducing the backward flow of blood through the mitral valve in the heart.

The NCD provides a national framework for Medicare coverage that can help people gain more timely access to the MitraClip treatment if they meet the eligibility requirements, which are based on CMS’s analysis of the clinical evidence supporting the device. Multiple trials, published reports, and registries of people treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalisations for heart failure, even in some of the most ill and debilitated patients.

CMS also approved a New Technology Add-On Payment (NTAP) for the MitraClip system earlier this month, recognising the substantial clinical benefits of this breakthrough innovation. The NTAP is designed to promote hospital adoption of new technologies that could benefit Medicare beneficiaries by enabling hospitals to obtain supplemental funding.

“We commend the extensive collaborative efforts of the CMS, FDA and medical societies in achieving this significant milestone of establishing a national coverage framework for Transcatheter Mitral Valve Repair,” says Charles A Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The National Coverage Determination and the New Technology Add-On Payment are important steps in helping people who need the MitraClip therapy gain timely access to treatment.”

Abbott’s MitraClip system repairs the mitral valve in people with severe degenerative mitral regurgitation without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving quality of life. People undergoing the MitraClip treatment typically experience short recovery times and short hospital stays of two to three days. MitraClip was approved by the US Food and Drug Administration (FDA) in October 2013 and received CE mark approval in 2008. After FDA approval, CMS initiated an NCD based on a multi-society request from the Society of Thoracic Surgeons (STS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and American Association for Thoracic Surgery (AATS).