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Reimbursement In Brief

This article was originally published in The Gray Sheet

Executive Summary

Carotid stenting NCD opened: CMS considers expanding coverage for Abbott Vascular's Xact carotid stent system in a national coverage decision opened Aug. 2. Guidant's endovascular business, since acquired by Abbott, requested in a March 31 letter that CMS cover carotid stenting in symptomatic, high surgical risk patients with carotid artery stenosis >50%, and in asymptomatic patients with stenosis >80% that would remove a stipulation in CMS' March 2005 coverage decision that patients with 50%-70% symptomatic stenosis be enrolled in an FDA-approved clinical study (1"The Gray Sheet" March 21, 2005, p. 14). Guidant cites "new and growing evidence" in its request for reconsideration. Consistent with CMS' request that new evidence be made public, Abbott writes in a June 14 letter that results from the Guidant sponsored ARCHeR trial and CAPTURE post-market registry are expected to be published in peer-reviewed journals within the next six months. CMS says this coverage decision will also consider formal accreditation processes for carotid stenting facilities. Initial comments are due Sept. 1, with a proposed decision expected in February...

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