National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00085R6

Issue

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).

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
American College of Cardiology View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/01/2008
Expected NCA Completion Date
10/29/2008
Public Comment Period
02/01/2008 - 03/02/2008
Proposed Decision Memo Due Date
Proposed Decision Memo Released
07/31/2008
Proposed Decision Memo Public Comment Period
07/31/2008 - 08/30/2008
Decision Memo Released
10/14/2008
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton, MHS
Sarah.fulton@cms.hhs.gov
410-786-2749
Lead Medical Officers
Lawrence Schott, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

February 1, 2008

Reviewed and accepted reconsideration request. View requestor letter.

During the initial 30-day public comment period, CMS is requesting public comments on coverage of PTA of the carotid artery concurrent with stent placement in Medicare beneficiaries who are at high risk for CEA due to anatomic factors and who have symptomatic carotid artery stenosis of ≥ 50% stenosis or asymptomatic carotid artery stenosis of ≥ 80%.

June 11, 2008

CMS receives an additional request to "consider a requirement that the national society registries serve as the CAS outcomes reporting mechanism, with simultaneous discontinuation of the current CMS CD-based data submission system."

View request. [PDF, 31KB]

July 31, 2008

Proposed decision memorandum posted and 30-day public comment period begins.

October 14, 2008

Final decision memorandum posted. NCD becomes effective.