Press Releases

MEDICARE ANNOUNCES ITS INTENTION TO COVER CAROTID ARTERY STENTING IN FDA REQUIRED POST-APPROVAL STUDIES

The Centers for Medicare & Medicaid Services (CMS) today announced its intention to expand coverage of Percutaneous Transluminal Angioplasty (PTA) of the carotid artery with placement of an FDA-approved carotid stent, to permit coverage for participants in a large FDA-mandated post-approval study for the newly approved device.

“We are increasing Medicare beneficiaries’ access to innovative treatment to prevent strokes and supporting the development of better evidence on how our beneficiaries can best use this new treatment,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

“This action is the result of work by Medicare staff in consultation with the FDA to make Medicare’s coverage decisions as timely as possible,” McClellan said.

FDA’s approval of the carotid stent system asked the study sponsor to complete the study as a condition of the approval. This carotid stenting system is used to treat patients who are at very high risk of stoke and cannot have surgery for their occluded carotid artery.

The study is designed to yield information that will help doctors target the new device to patients who are most likely to benefit from the procedure and to develop information on clinical practices that are associated with the best outcomes when using the new device.

These post-approval studies are also designed to understand whether the results of earlier clinical trials used for FDA approval can be generalized to other populations, settings, treatment regimens and outcomes.

Previously, 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 clinical trials).   FDA approval of this carotid stenting system would mean that it is no longer considered investigational and would not require an exemption.  Without this new coverage decision, Medicare would be unable to pay for carotid stenting performed in these FDA post-approval studies.

“This decision will help to expand the evidence base for future clinical policy decisions on carotid stenting. It also ensures that important clinical questions that go beyond basic regulatory requirements are addressed in a timely and reliable fashion,” CMS’ chief medical officer Sean Tunis, M.D., said.

CMS is also 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 CMS evidence-based review, which will involve public comment on a draft coverage decision, is scheduled to be completed in early 2005.

This proposed new coverage policy is available for review at the CMS coverage website (http://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html).   CMS expects to finalize this decision and begin coverage shortly after the end of the required 30-day public comment period.  This should coincide with the expected start date of enrollment of the post approval trial.