National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00085R3

Issue

CMS has received a coverage request to revise our current policy on carotid artery stenting (CAS) to now cover high surgical risk patients who are symptomatic with ≥ 50% stenosis or asymptomatic with ≥80% stenosis of the carotid artery. The request also proposes deleting language from the current policy that states that a patient should be determined to be a poor candidate for carotid endarterectomy (CEA) ‘in the opinion of a surgeon.’

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 and 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 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).

CMS will also use this NCD to explore the possibility of establishing more formal accreditation and recertification processes for CAS facilities, including those developed by national professional societies. CMS recognizes the importance of establishing these formal processes which are not in place under the current NCD.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Mary Bellack, Guidant Corporation View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/02/2006
Expected NCA Completion Date
05/02/2007
Public Comment Period
08/02/2006 - 09/01/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/01/2007
Proposed Decision Memo Public Comment Period
02/01/2007 - 03/03/2007
Decision Memo Released
04/30/2007
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton, MHS
Lead Medical Officers
Joseph Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

August 2, 2006

Reviewed and accepted reconsideration request. View requestor letters [PDF, 334KB].

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 and have symptomatic carotid artery stenosis ≥50% and Medicare beneficiaries who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥ 80%. We are also interested in comments regarding the language 'in the opinion of a surgeon' used in the current NCD and comments regarding a formal accreditation and recertification process for CAS facilities, particularly those sponsored by national professional societies. Of particular interest are comments supported by specific references to scientific studies. CMS is most interested in the quality of comments received rather than the quantity submitted.

Please submit public comments by using the “comment” button located at the top of the tracking sheet. This will provide you with a new window in which you may type your comment or cut and past a previously prepared comment. Additional instructions for submitting public comments are available at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

November 9, 2006

February 1, 2007

CMS posts a proposed decision memorandum  to modify section 20.7 of the Medicare NCD Manual. The 30-day public comment period begins.

CMS is requesting public comments on the proposed decision memorandum. CMS is particularly interested in the quality of data and evidence cited in public comments rather than the quantity of comments received. Instructions for submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

April 30, 2007

The final decision memo is posted.

May 30, 2007

Posted comments [PDF, 2MB] received.

View comments  received through the website.