CMS is again considering whether to expand Medicare coverage for carotid artery stenting.

The agency declined to broaden its national coverage policy for the procedure in two prior reconsiderations, in 2007 and 2008, but carotid stenting stakeholders hope data published since the last coverage analysis will prove convincing.

CMS opened an analysis March 18 to examine whether coverage should be extended to asymptomatic beneficiaries at high risk for carotid endarterectomy (CEA) surgery due to anatomic factors with carotid artery stenosis above 80%.

Since 2005, Medicare has covered stenting in patients considered high risk for surgery with symptomatic carotid artery blockage of 70% or greater. Other high surgical risk patients that fit within the FDA-approved population - which includes symptomatic patients with stenosis levels as low as 50% and asymptomatic patients with 80% or greater blockage - are covered only within the confines of an investigational device exemption clinical trial.

Stent makers unsuccessfully requested unrestricted coverage for all FDA-approved populations in 2006. In early 2008, interventionalists submitted a request focusing on a subset of patients at high risk for surgery due specifically to anatomical factors. Again CMS demurred, but it noted yet-to-be-published data could have an impact (¹ Also see "Rushed Judgment? CMS’ Status Quo Carotid Stenting Decision Comes Early" - Medtech Insight, 20 October, 2008., p. 5).

The day after CMS' October 2008 decision, results were published from Johnson & Johnson's 2,000-patient SAPPHIRE registry showing an adverse event rate for the Precise carotid stent system comparable to that seen with typically lower-risk surgery patients. Earlier this month, data published on Abbott's Acculink and Xact carotid stents also showed stenting event rates in line with American Heart Association guidelines for CEA. Other carotid stents include ev3's Protégé and Boston Scientific's WallStent and NexStent (² Also see "Research In Brief" - Medtech Insight, 16 March, 2009., p. 9).

CMS initiated the current coverage analysis on its own initiative. It does not address the 50%-70% stenosis symptomatic group included in FDA labeling. A proposed decision is due in September, with a final determination required by December.

- David Filmore (d.filmore@elsevier.com)

New Data Gives Carotid Stenting A Third Shot At Broader Medicare Coverage

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