National Coverage Analysis (NCA) Tracking Sheet

Intracranial Stenting and Angioplasty

CAG-00085R5

Issue

Stenosis of the intracranial arteries accounts for about 8 to 10% of all ischemic strokes in the United States. Medical therapy with antithrombotic agents such as aspirin to reduce ischemic events has been the standard treatment for intracranial arterial stenosis. With the high risk of subsequent events, other approaches to patients with symptomatic intracranial arterial stenosis have been considered and studied. In recent years, intracranial angioplasty with and without stent placement has been used in patients with significant intracranial arterial stenosis who either continue to have symptoms of a transient ischemic attack or develop a stroke while on treatment with antithrombotic medications. In 2005, the Boston Scientific Corporation received FDA approval of a Humanitarian Device Exemption (HDE) application for the Wingspan Stent System with Gateway PTA Balloon Catheter. The device 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 accessible to the system.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Parashar B. Patel, Vice President, Health Economics & Reimbursement, Boston Scientific Corporation View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/24/2007
Expected NCA Completion Date
05/14/2008
Public Comment Period
08/24/2007 - 09/23/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/14/2008
Proposed Decision Memo Public Comment Period
02/14/2008 - 03/15/2008
Decision Memo Released
05/12/2008
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sandy Jones, RN, MS
Lead Medical Officers
Joseph Chin, M.D.

Medicare Benefit Category Determination Date

Actions Taken

August 24, 2007

CMS opens this reconsideration of the NCD on intracranial stenting and angioplasty. The formal request is to remove the current non-coverage for intracranial stenting and angioplasty and to cover the stent when used in accordance with its FDA approval. The initial 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 technology under review.

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

September 18, 2007

CMS met with Boston Scientific Corporation's staff to discuss their draft observational clinical study.

September 23, 2007

Initial 30 day public comment period closes. Comments are posted at: http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=214.

January 7, 2008

CMS receives Boston Scientific Corporation's revised observational study.

February 14, 2008

CMS posts a proposed decision memorandum to make no change to 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.

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.

May 12, 2008

The final decision memo is now posted.