National Coverage Analysis (NCA) Tracking Sheet

Intracranial Stenting and Angioplasty

CAG-00085R2

Issue

CMS has received a request to provide coverage for intracranial stenting with angioplasty with a Humanitarian Use Device which recently was approved by the FDA for a Humanitarian Device Exemption. The device, the Wingspan Stent System with Gateway PTA Balloon Catheter, is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis that are acceptable to the system. This procedure is currently noncovered under NCD 20.7.

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
John Hernandez, PhD View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/09/2006
Expected NCA Completion Date
11/07/2006
Public Comment Period
02/09/2006 - 03/11/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/09/2006
Proposed Decision Memo Public Comment Period
08/09/2006 - 09/08/2006
Decision Memo Released
11/06/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton
Sarah.fulton@cms.hhs.gov
410-786-2749
Lead Medical Officers
Joseph Chin, M.D.

Medicare Benefit Category Determination Date

Actions Taken

February 09, 2006

Reviewed and accepted reconsideration request. View Requestor Letter [PDF, 38KB].

CMS is requesting public comments on coverage for intracranial stenting and angioplasty as a Humanitarian Device Exemption for the Medicare population. Instructions for submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

(View Comments [PDF, 4MB])

August 9, 2006

CMS posts a proposed decision memorandum to modify section 20.7 of the Medicare NCD manual.

At this time 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.

To submit a public comment please click on the orange "comment" button located at the top of this page and type or cut and paste your comment in the text box that appears. Comments of any length may be entered in this box. For more information about submitting public comments please visit http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

After the 30-day public comment period closes, CMS will review submitted comments and issue a final decision within 60 days.

(View Comments [PDF, 40KB])

November 6, 2006