Medicare NCD Expands Access to Abbott's MitraClip System

August 12, 2014—Abbott Vascular announced that the US Centers for Medicare & Medicaid Services (CMS) 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.

According to Abbott Vascular, the NCD provides a national framework for Medicare coverage that can help patients gain more timely access to MitraClip treatment if they meet the eligibility requirements, which are based on CMS’s analysis of the clinical evidence supporting the device. 

On August 5, the company announced that CMS also approved a New Technology Add-On Payment (NTAP) for the MitraClip system earlier this month, recognizing the clinical benefits of the device. The NTAP is designed to promote hospital adoption of new technologies that could benefit Medicare beneficiaries by enabling hospitals to obtain supplemental funding.

Abbott Vascular advised that 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 multisociety request from the Society of Thoracic Surgeons, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and American Association for Thoracic Surgery.

The MitraClip clip-delivery system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients in whom existing comorbidities would not preclude the expected benefit from reduced MR and those who have been determined to be at prohibitive risk for mitral valve surgery by a heart team. This team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease.

Abbott Vascular stated that the MitraClip system can significantly improve symptoms and quality of life by reducing the backward flow of blood through the mitral valve in the heart. Multiple trials, published reports, and registries of patients treated with the MitraClip device have consistently demonstrated a positive safety profile, reduction in MR, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients.

Abbott Vascular’s Chief Medical Officer, Charles A. Simonton, MD, commented in the company’s press release, “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. The NCD and the NTAP are important steps in helping people who need the MitraClip therapy gain timely access to treatment."