National Coverage Analysis (NCA) Tracking Sheet

Carotid Artery Stenting in Post-Approval Studies

CAG-00259N

Issue

Currently, Medicare only covers percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement in clinical trials that receive a Category B IDE designation from the FDA. We have initiated our analysis of this device (http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=128) and will post our final NCD in early 2005.

FDA has approved a carotid stenting system for limited indications. They have required a post approval study as a condition of approval. Due to our current non-coverage policy for carotid stents that are not part of Category B IDE trials, Medicare will be unable to pay for carotid stents in this study.

We intend to revise our current policy on carotid stents (NCD Manual (20.7) in order to extend coverage beyond Category B IDE clinical trials to include coverage of carotid artery stenting performed under the auspices of an FDA designated post approval study.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Internally generated request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
09/01/2004
Expected NCA Completion Date
10/05/2004
Public Comment Period
09/01/2004 - 10/01/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
09/01/2004
Proposed Decision Memo Public Comment Period
09/01/2004 - 10/01/2004
Decision Memo Released
10/12/2004

Contacts

Lead Analysts
Rana Hogarth, M.H.S.
Lead Medical Officers
Joe Chin, M.D.

Medicare Benefit Category Determination Date

Actions Taken

September 1, 2004

In order to ensure coverage of post approval studies for this technology in a timely fashion, we are posting our draft decision memorandum  with the opening of this NCD. We are soliciting public comment on this proposed expansion of clinical trial coverage to post approval studies for carotid stents and expect to post our final decision shortly after the close of the public comment period.

View Comments [PDF, 465KB]

October 12, 2004