National Coverage Analysis (NCA) Tracking Sheet

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

Issue

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.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor NameRequestor Letter
Multispecialty Carotid Alliance (MSCA) View Letter

Important Dates

Formal Request Accepted and Review Initiated
01/12/2023
Expected NCA Completion Date
10/10/2023
Public Comment Period
01/12/2023 - 02/11/2023
Proposed Decision Memo Due Date
07/12/2023
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton, MHS
sarah.fulton@cms.hhs.gov
410-786-2749
Lead Medical Officers
Joseph Hutter, MD

Actions Taken

January 12, 2023

CMS initiates this national coverage analysis for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.