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The Centers for Medicare & Medicaid Services (CMS) today issued a final National Coverage Determination expanding coverage of Percutaneous Transluminal Angioplasty (PTA) of the carotid artery with stenting to Medicare-eligible participants of a large FDA-mandated post-approval study for a newly approved carotid stent.

This final decision was issued shortly after a 30-day public comment period that followed CMS posting of a draft decision.  CMS had posted the draft decision one day after the FDA approved the first carotid artery stenting system, and this final CMS decision comes just five weeks after the FDA approval.

"This administration has shown its commitment to improving access to innovative medicine by responding quickly and allowing coverage Medicare-eligible enrolled in the FDA-required post-approval study," said CMS Administrator Mark B. McClellan, M.D., Ph.D.  "We are providing our beneficiaries with access to this important new technology while also expanding the evidence base for future improvements in preventing strokes in high-risk patients.

"This extremely rapid decision was made possible by excellent communication between CMS, the Food and Drug Administration and the manufacture of the approved stent," McClellan said, "and demonstrates the value of this type of interaction."

Comments received in response to the earlier draft decision were overwhelmingly positive. Most were from medical professional societies that were ultimately in favor of the expanded coverage, but also advocated for mechanisms in place to ensure appropriate use of this technology for the indicated patient population. 
 
CMS believes that carotid stenting in the setting of an FDA post-approval study reasonably assures patient protection through quality monitoring, and can provide Medicare beneficiaries the opportunity to receive the benefits of carotid stents.

The post-approval study will yield additional information that will help doctors target the new device to patients who are most likely to benefit from the procedure, and will develop information about the most appropriate clinical practices to follow with the new device.

Post-approval studies also can provide information on whether the results of earlier clinical trials used for FDA approval can be generalized to other populations, settings, treatment regimens and outcomes.

Before today's decision, CMS only covered PTA of the carotid artery concurrent with stent placement in clinical trials being conducted prior to FDA approval (so-called Category B Investigational Device Exemption [IDE] clinical trial).  FDA approval of this carotid stenting system means that it is no longer investigational for the approved use.  This new coverage decision enables Medicare to pay for carotid stenting performed for these FDA post-approval studies.

CMS 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).  This coverage determination process, which will involve public comment on a draft coverage decision, will be completed by early 2005.

"As with most medical devices, many important questions remain to be answered about optimal patient selection and how best to use the device after approval by the FDA.  The FDA-mandated post approval study will provide critical information to doctors and patients helping them to make well-informed, individualized decisions about how best to manage their carotid artery disease," said Dr. Sean Tunis MD, MSc, CMS chief medical officer.

"By providing coverage for important technologies while they undergo these additional important clinical studies, CMS is helping to support both innovation and effective, informed use of new medical technologies," Tunis said.

This coverage policy decision is effective today.  More information can be found at www.cms.hhs.gov/coverage.