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

Currently the Centers for Medicare & Medicaid Services (CMS) has a National Coverage Determination (NCD 20.7) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. Section B4 of the NCD covers PTA of the carotid artery concurrent with the placement of a Food and Drug Administration (FDA) approved carotid stent with embolic protection for:

• Patients at high risk for carotid endarterectomy (CEA) with symptomatic carotid artery stenosis ≥ 70%
• Patients at high risk for CEA with symptomatic carotid artery stenosis between 50 and 70% 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 (NCD 310.1), or in accordance with the NCD on carotid artery stenting (CAS) post-approval studies (NCD 20.7, B3)
• Patients at high risk for CEA with asymptomatic carotid artery stenosis ≥ 80% in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (NCD 310.1), or in accordance with the NCD on CAS post-approval studies (NCD 20.7, B3)

Section B4 of the NCD includes standards that facilities must meet and requires facilities to be approved by CMS and recertify every two years to perform CAS procedures. These requirements involved data submissions to CMS, however in 2017 CMS placed a moratorium on the data submission requirement.

CMS received and accepted a complete, formal request to reconsider NCD 20.7 from the Multispecialty Carotid Alliance (MSCA). MSCA is requesting that CMS 1) cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis ≥ 70% and in patients with symptomatic carotid artery stenosis ≥ 50%; 2) remove the requirement that patients are at high risk for CEA; 3) remove the facility and operator requirements; and 4) leave coverage for any CAS procedure not described in the NCD to MAC discretion.

CMS is soliciting public comment relevant to the request. We are particularly interested in scientific literature on the patients that clinically benefit from the procedure and any necessary considerations for the practitioners performing the procedures and the facilities in which the procedures are furnished. The scope of this reconsideration is limited to PTA concurrent with CAS including transcarotid artery revascularization (TCAR) procedures.

January 12, 2023

July 11, 2023

October 11, 2023