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Medical Policy: 07.01.32
Original Effective Date: July 2006
Reviewed: October 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
It is estimated that intracranial atherosclerotic lesions causes about 8% of all ischemic strokes. Intracranial stenosis may contribute to stroke in two ways: either due to embolism or low flow ischemia in the absence of collateral circulation. Recurrent annual stroke rates are estimated at 4%-12% per year with atherosclerosis of the intracranial anterior circulation, and 2.5%-15% per year with lesions of the posterior (vertebrobasilar) circulation. Medical treatment typically includes either anticoagulant therapy (i.e.,warfarin) or antiplatelet therapy (i.e.,aspirin).
Percutaneous transluminal angioplasty (PTA) has been approached cautiously for use in the intracranial circulation, due to technical difficulties in catheter and stent design and the risk of embolism, which may result in devastating complications if occurring in the posterior fossa or brain stem. However, improvement in the ability to track catheterization, allowing catheterization of tortuous veins, and the increased use of stents have lead to further research on PTA as minimally invasive treatment of this difficult-to-treat population. The majority of published research studies of intracranial PTA have focused on the vertebrobasilar circulation.
The Neurolink® system, marketed by the Guidant Corporation, is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with a stenosis greater than or equal to 50% and that are accessible to the stent system.
The WingspanTM Stent System with GatewayTM PTA Balloon Catheter, marketed by Boston Scientific, is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease that is refractory to medical therapy in intracranial vessels with stenosis that are greater than or equal to 50% that are accessible to the stent system.
In a trial sponsored by the Medical University of South Carolina, Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS), investigators plan to determine whether intracranial stenting with intensive medical therapy is superior to the medical therapy alone for preventing second stroke in high-risk patients with symptomatic stenosis of a major intracranial artery. Recent research has suggested a benefit in prevention of recurring stroke by aggressively treating risk factors such as hypertension, elevated LDL, and diabetes. It has been hypothesized that combining intracranial stenting with aggressive medical management will significantly decrease the incidence of a second stroke. In April 2011, the SAMMPRIS trial was halted due to the high risk of stroke and death in the stenting group according to the U.S. National Institutes of Health.
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Prior Approval:
Not applicable
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Policy:
Intracranial percutaneous angioplasty, with or without stenting, for the treatment of atherosclerotic lesions or intracranial vasospasm is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 61630 Balloon angioplasty, intracranial (eg, atherosclerotic stenosis), percutaneous
- 61635 Transcatheter placement of intravascular stent(s), intracranial (eg,atherosclerotic stenosis), including balloon angioplasty, if performed.
- 61640 Balloon dilatation of intracranial vasospasm, percutaneous; initial vessel
- 61641 Each additional vessel in same vascular family
- 61642 Each additional vessel in different vascular family
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Selected References:
- American Society for Interventional and Therapeutic Neuroradiology. Angioplasty and stenting of extracranial brachiocephalic stenoses. AJNR Am J Neuroradiol. 2001 Sep;22(8 Suppl):S31-3.
- FDA Summary of Safety and Probable Benefit. Neurolink® System. 2002
- FDA Summary of Safety and Probable Benefit. WingspanTM Stent System with GatewayTM PTA Balloon Catheter. 2004
- Hartmann M, Bose A, Berez S et al. Wingspan stent in intracranial atherosclerotic disease. Neuroradiology 2004; 46:S80.
- Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis. Cochrane Database Syst Rev 2005; 2:CD000516.
- Institute for Clinical Systems Improvement Technology Assessment Report (ICSI) Carotid, Vertebral and Intracranial Artery Angioplasty and Stenting. TA #93 June 2006.
- Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006 Jul 19;3:CD004133. Abstract viewed on line.
- Coward LJ, McCabe DJ, et al. Long-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis compared with medical treatment in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial. Stroke. 2007 May;38(5):1526-30.
- ECRI. NIH stroke study on stenting versus medical therapy halted. Plymouth Meeting (PA):ECRI Health Technology Information Service; 2011 April 15. (ECRI Health Technology Forecast). Also available: http://www.ecri.org.
- Higashida RT, Meyers PM, Connors JJ, et al. Intracranial Angioplasty and Stenting for Cerebral Atherosclerosis: A Position Statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, and the American Society of Neuroradiology. Journal of Vascular and Interventional Radiology. 2009 July;20(7 Suppl): S312-316.
- Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003.
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Policy History:
Date Reason Action
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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