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| NCA Tracking Sheet for 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. |
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| National Coverage Determination(s) | 20.7 | ||||
| Benefit Category | Inpatient Hospital Services, Physicians' Services | ||||
| Requestor Name(s) | Internally generated request | ||||
| Formal Request Accepted and Review Initiated | 9/1/2004 | ||||
| Expected NCA Completion Date | 10/5/2004 | ||||
| Public Comment Period | 9/1/2004 - 10/1/2004 | ||||
| Draft Decision Memo Due Date | 9/1/2004 | ||||
| Draft Decision Memo Released | 9/1/2004 | ||||
| Draft Decision Memo Public Comment Period | 9/1/2004 - 10/1/2004 | ||||
| Decision Memo Released | 10/12/2004 | ||||
| Lead Analyst(s) |
Rana Hogarth, M. H.S. rhogarth@cms.hhs.gov 1-410-786-2112 |
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| Lead Medical Officer(s) |
Joe Chin, M.D. jchin@cms.hhs.gov 1-410-786-4371 |
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| Actions Taken |
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