CMS Approves New Technology Add-On Payment for Abbott Vascular's MitraClip

August 5, 2014—Abbott Vascular advised that the US Center for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment for the company’s MitraClip transcatheter mitral valve repair system while maintaining the device within its current diagnosis-related group classification. CMS advised of this decision in its fiscal year 2015 ruling on the inpatient prospective payment system. 

The company noted that during the public comment period, several doctors and national medical societies commented on the importance of establishing adequate reimbursement for MitraClip to ensure access to the therapy. MitraClip is delivered transfemorally and, once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. 

In Abbott Vascular’s press release, Chief Medical Officer Charles Simonton, MD, stated, “Approval of this New Technology Add-On Payment recognizes the breakthrough medical innovation of MitraClip and the substantial clinical improvement this technology offers for very sick patients who have no alternative effective treatment options. This decision is an important step forward in improving access to the therapy for these vulnerable patients while more appropriate hospital reimbursement for MitraClip is established.”

Cardiac Interventions Today’s Chief Medical Editor, Ted E. Feldman, MD, commented, “The MitraClip procedure is performed using general anesthesia and transesophageal echo guidance, which utilizes hospital resources similar to surgical mitral repair. While the new add-on payment is clearly helpful, it will still be challenging for hospitals to manage this therapy.”

In October 2013, Abbott Vascular announced US Food and Drug Administration approval and the United States market launch of MitraClip. The device has been approved for patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery. At that time, the company noted that multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrated a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients. The MitraClip device received European CE Mark approval in 2008.