Medicare Compliance & Reimbursement

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 with data needed to assess risks and determine which patients are most appropriate for carotid artery stenting.

A national coverage determination is currently open to determine whether PTA of the carotid artery with carotid stent placement may be reasonable and necessary for Medicare beneficiaries outside of IDE trials and FDA post-approval studies. That determination will be issued in the next several months, the memo said.