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CMS To Take Lead On Monitoring Carotid Artery Stenting Facility Expertise

This article was originally published in The Gray Sheet

Executive Summary

Facilities and physicians performing carotid artery stenting will be monitored for competency by CMS, due to an absence of consensus over which organization should spearhead efforts

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Carotid Stent Firms See Another Step Into Market With Expanded Coverage

Carotid artery stent manufacturers hope to maintain momentum in an evolving market in which they see significant potential for growth

Carotid Stent Firms See Another Step Into Market With Expanded Coverage

Carotid artery stent manufacturers hope to maintain momentum in an evolving market in which they see significant potential for growth

Reimbursement In Brief

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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