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Medical Policy: 07.01.27
Original Effective Date: June 2005
Reviewed: December 2011
Revised: November 2007
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:
The success of coronary artery angioplasty and stenting prompted interest in applications of catheter-based endovascular intervention in coronary artery disease. Combined with optimal medical management, carotid angioplasty with or without stenting has been evaluated as an alternative to carotid endarterectomy, currently considered the standard treatment for patients with significantly obstructing carotid atherosclerosis. Carotid angioplasty and stenting involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices through the femoral artery. The procedure typically takes 20-40 minutes. Interventionalists almost uniformly use an embolic protection device designed to reduce the risk of stroke caused by thromboembolic material dislodged during angioplasty and stenting. Carotid angioplasty is rarely performed without stent placement.
Proposed advantages of carotid angioplasty and stenting over carotid endarterectomy include:
- General anesthesia is not used (although carotid endarterectomy can be performed under local/regional anesthesia)
- Cranial nerve palsies are infrequent sequelae (although most following carotid endarterectomy resolve over time)
- Simultaneous procedures may be performed on the coronary and carotid arteries
The U.S Food and Drug Administration (FDA) has approved carotid artery stents and embolic protection devices from various manufacturers:
- ACCULINK™ and RX ACCULINK™ carotid stents and ACCUNET™ and RX ACCUNET™ cerebral protection filters; Guidant Corp. (approved August 2004)
- Xact® RX carotid stent system and Emboshield® embolic protection system; Abbott Vascular Devices (approved September 2005)
- Precise® nitinol carotid stent system and AngioGuard™ XP and RX emboli capture guidewire systems; Cordis Corp. (approved September 2006)
- NexStent® carotid stent over-the-wire and monorail delivery systems, Endotex Interventional Systems; and FilterWire EZ™ embolic protection system, Boston Scientific Corp. (approved October 2006)
- ProtégéRX® and SpideRx®; ev3 Inc, Arterial Evolution Technology (approved January 2007)
- Carotid Wallstent®, Boston Scientific Corp. (approved October 2008); and
- Mo.Ma® Ultra Proximal Cerebral Protection Device; Invatec S.P.A. (approved October 2009)
Each FDA-approved carotid stent system is indicated for combined use with and embolic protection device to reduce the risk of stroke in patients considered to be at increased risk for periprocedural complications from carotid endarterectomy who are symptomatic with greater than 50% stenosis, or asymptomatic with greater than 80% stenosis. Patients are considered at increased risk for complications during carotid endarterectomy if affected by any item from a list of anatomic features and comorbid conditions included in each stent system’s information for prescribers.
FDA-approved stents and embolic protection devices differ in deployment methods used once they reach the target lesion with the RX (rapid exchange) devices designed for more rapid stent and filter expansion. The Precise® and AngioGuard™ devices were studied in a randomized, controlled trial (the SAPPHIRE trial). Other devices were approved based on uncontrolled, single-arm trials or registries, and comparison to historical controls. The FDA has mandated postmarketing studies for these devices, including longer follow-up for patients already reported to the FDA and additional registry studies, primarily to compare outcomes as a function of clinician training and facility experience. Each manufacturer’s system is available in various configurations (e.g., straight or tapered) and sizes (diameters and lengths) to match the vessel lumen that will receive the stent.
Please see the related policy 07.01.32 Percutaneous Intracranial Angioplasty and Stenting
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Prior Approval:
Not applicable
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Policy:
A substantive body of evidence does not support the use of carotid angioplasty and stenting in carotid artery disease. However, based on limited data, clinical input, the chain of indirect evidence, and an unmet medical need, carotid angioplasty and stenting may be considered a reasonable and medically necessary option in recently symptomatic patients when carotid endarterectomy cannot be performed due to anatomic reasons.
Carotid angioplasty with associated stenting and embolic protection may be considered medically necessary in patients with:
- 50-90% stenosis AND
- Symptoms of focal cerebral ischemia (transient ischemic attack or monocular blindness) in previous 120 days, symptom duration less than 24 hours, or nondisabling stroke; AND
- Anatomic contraindication for carotid endarterectomy (such as prior radiation treatment or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy)
Carotid angioplasty with or without associated stenting and embolic protection is considered investigational for all other indications.
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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.
- 0075T Transcatheter placement of extracranial vertebral or intrathoracic carotid artery stent(s), including radiologic supervision and interpretations, percutaneous; initial vessel.
- 0076T Transcatheter placement of extracranial vertebral or intrathoracic carotid artery stent(s), including radiologic supervision and interpretation, percutaneous; each additional vessel (List separately in addition to code for primary procedure)
- 37215 Transcatheter placement of intravascular stents(s), cervical carotid artery, percutaneous; with distal embolic protection
- 37216 Transcatheter placement of intravascular stent(s), cervical carotid artery, percutaneous; without distal embolic protection
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Selected References:
- Yadav JS, Wholey MH, Kuntz RE et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med, (2004) 351(15):1493-501.
- Health Technology Assessment Information Service. Carotid stenting with embolic protection for carotid artery stenosis. ECRI TARGET Report. (2004, October).
- Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. (Cochrane Review) In: The Cochrane Library, Issue 4, 2004.
- CAVATAS Investigators. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet. 2001 Jun 2;357(9270):1729-37.
- Golledge J, Mitchell A, Greenhalgh RM, Davies AH. Systematic comparison of the early outcome of angioplasty and endarterectomy for symptomatic carotid artery disease. Stroke. 2000 Jun;31(6):1439-43.
- Naylor AR, Bolia A, Abbott RJ, et al. Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial. J Vasc Surg. 1998 Aug;28(2):326-34.
- American Heart Association's Councils on Cardiovascular Radiology, Stroke, Cardio-Thoracic and Vascular Surgery, Epidemiology and Prevention, and Clinical Cardiology. Carotid stenting and angioplasty. Circulation: 1998; 97:121-123.
- Sacco RL, Adams R, Albers G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals form the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006;37(2);577-617.
- Blue Cross Blue Shield Association (BCBSA), Technology Evaluation Center (TEC). Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation. TEC Assessment Program. Chicago, IL:BCBSA; June 2007;22(1). Available at: http://www.bcbs.com/betterknowledge/tec/vols/22/angioplasty-and-stenting-of.html. Accessed April 17, 2009.
- ECRI. Carotid Stenting with Embolic Protection for Carotid Artery Stenosis. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 March 20. 11p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- Health technology forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2010 Apr 06. Carotid stenting with embolic protection for carotid artery stenosis. Available: http://www.ecri.org.
- Brott T, Hobson R, Howard G, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. The New England Journal of Medicine;2010 Jul 1;363(1);11-23.
- Fox AJ. How to measure carotid stenosis. Radiology. 1993 Feb; 186(2): 316-18.
- Brott TG, Halperin JL, Abbara S et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Neurointerventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Stroke 2011; [Epub ahead of print].
- Woo K, Garg J, Hye RJ et al. Contemporary results of carotid endarterectomy for asymptomatic carotid stenosis. Stroke 2010; 41(5):975-9.
- Silver FL, Mackey A, Clark WM et al. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke 2011;42(3):675-680.
- Rothwell PM. Carotid stenting: more risky than endarterectomy and often no better than medical treatment alone. Lancet 2010; 375(9719):957-9.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Angioplasty and stenting of th e cervical carotid artery with embolic protection of the cerebral circulation. TEC Assessments 2099; Volume 24, Tab 12.
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Policy History:
Date Reason Action
October 2010 Annual review Policy renewed
December 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
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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