FDAnews
www.fdanews.com/articles/70029-cms-to-cover-stent-procedure-costs

CMS to Cover Stent Procedure Costs

March 18, 2005

The Centers for Medicare & Medicaid Services (CMS) issued a final decision that would immediately expand coverage of carotid artery stenting for high-risk patients with symptomatic narrowing of carotid artery of 70 percent or more.

Agency officials said the CMS will limit the number of facilities and surgeons who can receive government reimbursement for the procedure to "ensure optimal patient outcomes" and better evaluate performance of the hospitals and doctors.

The CMS will also cover patients who meet the FDA-labeled criteria for carotid stents -- those who are at high risk for carotid endarterectomy surgery and have symptomatic carotid artery stenosis between 50 percent and 70 percent and those who are asymptomatic high-risk patients with carotid artery stenosis of 80 percent or more -- in Category B investigational device exemption clinical trials, as a routine cost under the clinical trials policy, or in postapproval studies.