CMS Coverage Decision Clears Path for Greater Use of Abbott’s MitraClip

The Centers for Medicare & Medicaid Services (CMS) has 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 officials from Abbott Park, Ill.-based Abbott Vascular, MitraClip is a “first-of-its-kind” device for people with severe degenerative mitral regurgitation (the backward flow of blood through the mitral valve in the heart) who are not good candidates for surgery.

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 analysis of the clinical evidence supporting the device.

CMS also approved a new technology add-on payment (NTAP) for the MitraClip System earlier this month. 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 (U.S. Food and Drug Administration) and medical societies in achieving this significant milestone of establishing a national coverage framework for transcatheter mitral valve repair,” said Charles A. Simonton, M.D., divisional vice president of medical affairs and chief medical officer for 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.”

Mitral regurgitation can raise the risk of irregular heartbeats, stroke and heart failure, which can be deadly. Mitral regurgitation is common, affecting more than 4 million Americans—nearly one in 10 people aged 75 and older, according to figures cited by the company. Open-heart mitral valve surgery is the standard of care treatment, but many people are at prohibitive risk for an invasive procedure. Medications for the condition are limited to symptom management and do not stop the progression of the disease.

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.

People undergoing the MitraClip treatment typically experience short recovery times and short hospital stays of two to three days. MitraClip was approved by the FDA in October 2013 and received CE mark in 2008. After FDA approval, CMS initiated an NCD based on a multi-society request from the Society of Thoracic Surgeons, American College of Cardiology, Society for Cardiovascular Angiography and Interventions and American Association for Thoracic Surgery.

Abbott Vascular, a division of Abbott Labs, makes products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.