Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting

CMS has internally generated a reconsideration request for PTA of the carotid artery concurrent with stenting. In the last reconsideration (CAG-00085R6) CMS stated that "We are aware of other data that has yet to be published and strongly urge that publication at the soonest possible time. We will work with any requestor as soon as that data is published to determine the need for an expedited review and reconsideration." New data has recently been published that examines outcomes in patients for whom coverage is currently limited to participation in clinical trials and post approval studies. In this reconsideration, CMS will examine whether coverage should be expanded to beneficiaries who are at high risk for CEA due to anatomic risk factors with asymptomatic carotid artery stenosis of ≥ 80%.

Under the current policy patients at high risk for carotid endarterectomy (CEA) who have symptomatic carotid artery stenosis > 70% are covered for procedures performed using FDA approved CAS systems with embolic protection devices in facilities approved by CMS to perform CAS procedures. In addition, patients at high risk for CEA with symptomatic carotid artery stenosis between 50% and 70% and patients at high risk for CEA with asymptomatic carotid artery stenosis ≥ 80% are covered in accordance with the Category B Investigational Device Exemption (IDE) clinical trials regulation (42, CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post approval studies (Medicare NCD Manual 20.7,B3).

March 18, 2009

September 10, 2009

December 9, 2009