Carotid stents gain Medicare coverage despite questions about clinical effectiveness

February 16, 2007

The Centers for Medicare and Medicaid Services has proposed expanding coverage for carotid artery stenting to include asymptomatic patients younger than 80 who have been enrolled in clinical trials.

The Centers for Medicare and Medicaid Services has proposed expanding coverage for carotid artery stenting to include asymptomatic patients younger than 80 who have been enrolled in clinical trials.

CMS released the Feb. 1 proposal noting that several studies show carotid stenting should be the preferred choice for asymptomatic patients who have <80% stenoses and are poor candidates for carotid endarterectomy, according to The Gray Sheet. CMS will, however, maintain its policy that high-risk symptomatic patients with 50% to 70% stenosis be enrolled in FDA-approved studies to get coverage.

Manufacturers asked CMS in August 2006 to match current FDA indications for carotid stenting.

The relative efficacy of carotid stenting compared with carotid endarterectomy for treating carotid plaques has recently been questioned. CMS cited two randomized trials - SPACE and EVA-3S - that failed to show that carotid stenting was more effective than endarterectomy in symptomatic patients with at least 50% stenosis.

Several other trials, including the CAPTURE registry for the Cordis Precise stent, have shown a significantly higher rate of death, stroke, or heart attack within 30 days of intervention in patients over 80 compared with younger patients. All carotid stenting candidates over 80 must be enrolled in an FDA-sanctioned trial to qualify for Medicare coverage.

CMS also proposed specific data analysis requirements for facilities to maintain certification, according to The Gray Sheet. The agency asked for advice on an offer from the Society for Cardiovascular Angiography and Interventions to take over certification duties. Comments on the coverage proposal are due March 3, and a decision should be made by May 2.

For more information from the Diagnostic Imaging archives:

First long-term data confirm cognitive benefit from carotid stenting

Carotid artery stenting in elderly offers safe option

Carotid stenting offers new interventional practice option

Carotid artery stenting takes off amid governmental limitations