tci Medicare Compliance & Reimbursement - 2004 Issue 36

Coverage: CMS Takes Closer Look At Stent Replacement

Medicare coverage for a new stroke-prevention procedure could be coming down the pike.In a Sept. 1 draft decision memo, the Centers for Medicare and Medicaid Services deems Medicare coverage of percutaneous transluminal angioplasty with carotid stent placement "reasonable and necessary" when performed in a Food and Drug Administration required post-approval study. The carotid stent can help treat patients considered too high-risk for carotid endarterectomy.Because the FDA has approved the device, Medicare can no longer provide coverage under the Category B investigational device exemption clinical trials, according to CMS. The expanded coverage of post-approval studies will furnish practitioners...

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