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CMS has accepted a formal complete request to initiate an NCA for percutaneous, transcatheter, intraluminal left atrial appendage (LAA) closure using an implanted device.
Some patients with nonvalvular atrial fibrillation (AF), an abnormally rapid, irregular heartbeat, are at an increased risk of stroke. Echocardiographic evidence suggests that many of the strokes in patients with AF originate from the left atrium of the heart. The left atrial appendage (LAA) a tubular structure attachment that opens into the left atrium. The LAA has been shown to be one potential source for clots that can cause strokes. While thinning the blood with anticoagulant medications has been proven to prevent strokes, percutaneous LAA closure has been studied as a non-pharmacologic alternative for certain patients. The scope of this NCA does not include surgical techniques used to achieve LAA closure.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.
May 21, 2015
CMS initiates this national coverage analysis for Percutaneous Left Appendage Closure Therapy. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.
CMS considers all public comments, and is particularly interested in comments that include published clinical studies and other scientific information that provides evidence for improvement in short and long term outcomes related to this screening service.
Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word COMMENT in the title bar at the top of this page.
We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.
November 10, 2015
February 8, 2016