CMS Proposes Restricted Coverage for LAA Closure Therapy
November 13, 2015—The Centers for Medicare & Medicaid Services (CMS) has issued a proposed decision memo, CAG-00445N, for percutaneous left atrial appendage (LAA) closure therapy, which is available online. The Watchman device (Boston Scientific Corporation) is the only LAA occlusion device that has been approved by the US Food and Drug Administration (FDA).
Public comments to the proposed decision memo can be submitted via the preceding link. CMS is requesting public comments on this proposed determination and is specifically interested in public comments on the use of the Coverage with Evidence Development (CED) paradigm in this decision. After considering the public comments, CMS will make a final determination and issue a final decision memorandum.
CMS proposes that the evidence is sufficient to determine percutaneous LAA closure therapy using an implanted device is not reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member and, therefore, is not covered under the relevant provisions of the Social Security Act.
In order to support evidence development for technologies likely to show benefit for the Medicare population, CMS proposes to cover items or services that are reasonable and necessary for research under the law using the CED paradigm.
CMS proposes that coverage would be limited to items and services in clinical studies as outlined in the proposed decision memo.
Therefore, percutaneous LAA closure therapy is covered for patients with nonvalvular atrial fibrillation only when seven conditions are met. These conditions—fully outlined in the document—address the device (must be FDA approved for patients with nonvalvular atrial fibrillation); the patient (must have a specified severity of illness and a contraindication to warfarin); hospital facilities criteria; physician-operator qualifications; and patients must be enrolled in prospective national registry, with specifications for those registries detailed in the proposed decision memo.
Additionally, a formal shared decision-making interaction between the patient and provider using an evidence-based decision tool on anticoagulation in patients with nonvalvular atrial fibrillation must occur before LAA closure treatment, must be documented in the medical records, must include a discussion of the benefits and harms, must document an appropriate rationale to seek a nonpharmacologic alternative to anticoagulants, taking into account the safety and effectiveness of the device compared to anticoagulants, and have, after being informed of the reported risks of LAA closure and reasonable alternative management strategies, given informed consent.
In March 2015, Boston Scientific announced the FDA approval of the Watchman LAA closure device as an option for high-risk patients with nonvalvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The company advised that the Watchman device would be made available in the United States to centers involved in Boston Scientific clinical studies, and in additional specialized centers as physicians are trained on the implantation procedure.
In June, the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions announced the publication a new overview on the implantation of LAA occlusion devices.