Under the decision, Medicare will cover implantation of the device only if the heart team and hospital are participating in a prospective, national, audited registry that follows patients for at least one year and tracks patient outcomes. The CMS sets this type of evidence-development requirement for services for which there are still questions about clinical effectiveness.
The MitraClip is approved only for people who are poor risks for open heart surgery. About 4 million Americans have a defective mitral valve that allows too much blood to be pumped into the blood vessels of the lungs. While most patients can be treated through open-heart surgery to repair the valve, about 350,000 have risk factors that essentially rule out surgery. Analysts say a broader range of cardiac patients eventually may become eligible for MitraClip implantation.
Thursday's coverage decision would apply to any future devices to treat mitral regurgitation that receive FDA approval. The CMS' proposed approval comes with certain conditions, including mandatory FDA approval for the device and requirements that a cardiac surgeon experienced in mitral-valve surgery and a cardiologist experienced in mitral-valve disease must independently determine that traditional surgery for a beneficiary would be too risky. In addition, the procedure must be performed in a hospital that has an on-site heart-valve surgery program and a cardiac catheterization lab.
In requiring that patients be tracked through a registry, the CMS indicated it wanted to see the long-term durability of the MitraClip device and benefits and risks of the treatment.
The coverage decision follows an Aug. 4 announcement by the CMS that it would offer a new technology add-on payment for providers doing MitraClip implants. Providers were critical of the rate the agency previously had paid for the procedure.
Under the new payment policy, Medicare will pay the previous DRG rate plus up to 50% of the cost of the device, which sells for about $30,000. The bump will result in $27 million in additional payments for fiscal 2015, the CMS estimated.
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