CMS finalizes coverage for carotid artery stenting

The U.S. Centers for Medicare and Medicaid Services (CMS) has expanded coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting. The final national coverage determination (NCD) applies to Medicare-eligible participants of a Food and Drug Administration-mandated postapproval study for a newly approved carotid stent.

Before the decision, CMS covered only PTA of the carotid artery concurrent with stent placement in clinical trials being conducted prior to FDA approval (Category B Investigational Device Exemption [IDE] clinical trials). The FDA's approval of the carotid stenting system means that it is no longer investigational for the approved use, CMS said.

The agency also is evaluating a separate request for a broader coverage expansion of PTA of the carotid artery concurrent with stent placement for patients at high risk for carotid endarterectomy (CEA). The coverage determination process, which will involve public comment on a draft coverage decision, will be completed by early 2005, according to CMS.

The NCD memorandum is available on the CMS Web site.

By staff writers
October 13, 2004

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