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

CMS has received a coverage request to revise our current policy on carotid artery stenting (CAS) to now cover “patients who are at high risk for carotid endarterectomy (CEA) due to defined anatomic factors, and who have either symptomatic carotid artery stenosis of 50 - 69% (or greater) or asymptomatic carotid artery stenosis of ≥ 80%.

Under the current policy patients at high risk for 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 asymptomatic 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).

February 1, 2008

June 11, 2008

July 31, 2008

October 14, 2008