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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-61000-35

Original Effective Date: 07/15/08

Reviewed: 03/26/15

Revised: 01/01/16

Subject: Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms) and Extracranial Vertebral Artery Disease

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update  
           

DESCRIPTION:

Intracranial Arterial Disease

Intracranial arterial disease includes thromboembolic events, vascular stenoses, and aneurysms. Endovascular techniques have been investigated for treatment of intracranial arterial disease, as an alternative to intravenous tissue plasminogen activator (tPA) and supportive care for acute stenosis and as an alternative to risk factor modification for chronic stenosis. For cerebral aneurysms, stent-assisted coiling and the use of flow-diverting stents have been evaluated as an alternative to endovascular coiling in patients whose anatomy is not amenable to simple coiling.

Cerebrovascular diseases include a range of processes affecting the cerebral vascular system, including arterial thromboembolism, arterial stenosis, and arterial aneurysms, all of which can lead to restrictions in cerebral blood flow due to ischemia or hemorrhage. Endovascular techniques, including endovascular pharmacologic thrombolysis, endovascular mechanical embolectomy; using one of several types of devices, endovascular deployment of several types of stents, and angioplasty with or without stenting, have been investigated for treatment of cerebrovascular diseases.

Extracranial Vertebral Artery Disease

Vertebral artery diseases, including atherosclerotic stenosis, dissections, and aneurysms, can lead to ischemia of the posterior cerebral circulation. Conventional management of extracranial vertebral artery diseases may include medical therapy, including antiplatelet or anticoagulant medications and medications to reduce atherosclerotic disease risk (eg, statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.

The management of extracranial vertebral artery aneurysms or dissections is controversial due to uncertainty about the risk of thromboembolic events associated with aneurysms/dissections. Antiplatelet therapy is typically used; surgical repair, which may include vertebral bypass, external carotid autograft, and vertebral artery transposition to the internal carotid artery, or endovascular treatment with stent placement or coil embolization, may also be used. Given the technical difficulties related to surgical access of the extracranial vertebral artery, endovascular therapies have been investigated for extracranial vertebral artery disease. Endovascular therapy may consist of percutaneous transluminal angioplasty (PTA), with or without stent implantation.

POSITION STATEMENT:

Intracranial Arterial Disease

Intracranial stent placement meets the definition of medical necessity when utilized as part of the endovascular treatment of intracranial aneurysms for patients when surgical treatment is not appropriate AND standard endovascular techniques do not allow for complete isolation of the aneurysm, (e.g., wide-neck aneurysm of 4 mm or more, or sack-to-neck ratio less than 2:1).

The use of endovascular mechanical embolectomy, with an FDA (U.S. Food and Drug Administration) approved device for the treatment of acute ischemic stroke, meets the definition of medical necessity as part of the treatment of acute ischemic stroke for members who meet ALL of the following criteria:

• A demonstrated occlusion within the proximal intracranial anterior circulation (intracranial internal carotid artery, or M1 or M2 segments of the middle cerebral artery, or A1 or A2 segments of the anterior cerebral artery); AND

• Can receive endovascular mechanical embolectomy within 12 hours of symptom onset; AND

• Evidence of substantial and clinically significant neurological deficits (e.g. baseline (post-stroke) National Institutes of Health Stroke Scale (NIHSS) score); AND

• Evidence of salvageable brain tissue in the affected vascular territory (e.g. Alberta Stroke Program Early CT (ASPECTs) score); AND

• No evidence of intracranial hemorrhage or arterial dissection on CT or MRI imaging.

The use of endovascular mechanical embolectomy for all other indications is considered experimental or investigational. The evidence is insufficient to determine the effects of the technology on health outcomes.

Intracranial stent placement is considered experimental or investigational in the treatment of intracranial aneurysms except as noted above. The evidence is insufficient to determine the effects of the technology on health outcomes.

Intracranial percutaneous transluminal angioplasty with or without stenting is considered experimental or investigational in the treatment of atherosclerotic cerebrovascular disease. The evidence is sufficient to determine qualitatively that the technology is unlikely to improve the net health outcome.

Extracranial Vertebral Artery Disease

Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered experimental or investigational for the management of extracranial vertebral artery disease. The evidence is insufficient to determine whether endovascular therapy for extracranial vertebral artery dissections, aneurysms, and AV fistulae improves the net health outcome.

BILLING/CODING INFORMATION:

CPT Coding

37184

Primary percutaneous transluminal mechanical thrombectomy, noncoronary, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); initial vessel

37185

Primary percutaneous transluminal mechanical thrombectomy, noncoronary, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); second and all subsequent vessel(s) within the same vascular family (List separately in addition to code for primary mechanical thrombectomy procedure)

61630

Balloon angioplasty, intracranial (e.g., atherosclerotic stenosis), percutaneous

61635

Transcatheter placement of intravascular stent(s), intracranial (e.g., atherosclerotic stenosis), including balloon angioplasty, if performed

61640

Balloon dilatation of intracranial vasospasm, percutaneous; initial vessel (Investigational)

61641

Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in same vascular family (List separately in addition to code for primary procedure) (Investigational)

61642

Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in different vascular family (List separately in addition to code for primary procedure) (Investigational)

61645

Percutaneous arterial transluminal mechanical thrombectomy and/or infusion for thrombolysis, intracranial, any method, including diagnostic angiography, fluoroscopic guidance, catheter placement, and intraprocedural pharmacological thrombolytic injection(s)

61650

Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement, diagnostic angiography, and imaging guidance; initial vascular territory

61651

Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement, diagnostic angiography, and imaging guidance; each additional vascular territory (List separately in addition to code for primary procedure)

0075T

Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel (Investigational)

0076T

Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure) (Investigational)

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT and PROGRAM EXCEPTIONS.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Percutaneous Transluminal Angioplasty (PTA) (20.7) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other applicable indexing terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Merci® Retriever

Neurolink System

Penumbra System®

Pipeline® Embolization DeviceSolitaire™ Flow Restoration Device

Trevo® Retriever

Vertebrobasilar stenosis, angioplasty

Wingspan Stent System

REFERENCES:

  1. Abruzzo TA, Tong FC, Waldrop AS, Workman MJ, Cloft HJ, Dion JE. Basilar artery stent angioplasty for symptomatic intracranial athero-occlusive disease: complications and late midterm clinical outcomes. AJNR Am J Neuroradiol. 2007 May;28(5):808-15.
  2. ASA/ACCF/HAA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS. Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease. 2011; accessed at circ.ahajournals.org 02/17/15.
  3. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 2.01.54. Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms) 09/15.
  4. Blue Cross Blue Shield Association. Medical Policy Reference Manual, 7.01.148 Endovascular Therapies for Extracranial Vertebral Artery Disease, 02/15.
  5. Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. Epub 2007 Mar 29.
  6. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 1, Section 20.7 Percutaneous Transluminal Angioplasty (PTA), (05/12/08 reaffirmed the existing National Coverage Decision for PTA with Intracranial Stenting. Effective date: 05/12/2008. Implementation date: 08/11/2008).
  7. Centers for Medicare and Medicaid Services (CMS) Decision Memo for Intracranial Stenting and Angioplasty (CAG-00085R5). Centers for Medicare and Medicaid Services. Available online at: http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=214&fromdb=true. Accessed 06/15/12.
  8. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7) 03/11/13; accessed at cms.gov 02/17/15.
  9. Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16.
  10. ClinicalTrials.gov. Stenting vs. Aggressive Medical Management for preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS). NCT00576693.
  11. ClinicalTrials.gov - Safety and Efficacy of Neuroform3™ for Intracranial Aneurysm Treatment (SENAT). NCT00928265. Last updated May 31, 2013.
  12. Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD004133. DOI: 10.1002/14651858. CD004133.pub2.
  13. Derdeyn CP, Chimowitz MI. Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007 Aug;17(3):355-63, viii-ix. Review.
  14. Derdeyn CP, Fiorella D, Lynn MJ, Rumboldt Z, Cloft HJ, Gibson D, Turan TN, Lane BF, Janis LS, Chimowitz MI; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Mechanisms of stroke after intracranial angioplasty and stenting in the SAMMPRIS trial. Neurosurgery. 2013 May;72(5):777-95; discussion 795.
  15. Derdeyn CP, Fiorella D, Lynn MJ, Turan TN, Lane BF, Janis LS, Chimowitz MI. Intracranial stenting: SAMMPRIS. Stroke. 2013 Jun;44(6 Suppl 1):S41-4.
  16. ECRI. Emerging Technology Report. Flow-diverting Stent (Pipeline Embolization Device) for Treating Unruptured Large and Giant Wide-necked Intracranial Aneurysms (07/03/2013).
  17. ECRI. Health Technology Trends, Vol. 18, No. 8. New Stent may help prevent stroke by opening narrowed arteries deep within the brain. Plymouth Meeting, PA: ECRI. August 2006.
  18. ECRI. NIH stroke study on stenting versus medical therapy halted. Published 04/15/2011.
  19. European Stroke Organisation, Tendera M, Aboyans V, et al. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. Nov 2011;32(22):2851-2906.
  20. Fiorella D, Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Hanel RA, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. US multicenter experience with the wingspan stent system for the treatment of intracranial atheromatous disease: periprocedural results. Stroke. 2007 Mar; 38(3): 881-7. Epub 2007 Feb 8.
  21. Fiorella D, Derdeyn CP, et al. Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS). Stroke. 2012 Oct;43(10):2682-8.
  22. Freitas JM, Zenteno M, Aburto-Murrieta Y, Koppe G, Abath C, Nunes JA, Raupp E, Hidalgo R, Pieruccetti MA, Lee A. Intracranial arterial stenting for symptomatic stenoses: a Latin American experience. Surg Neurol. 2007 Oct; 68(4):378-86.
  23. Groschel K, Schaudigel S, Pilgram SM et al. A systematic review on outcome after stenting for intracranial atherosclerosis. Stroke 2009; 40(5):e340-7.
  24. Henkes H, Miloslavski E, Lowens S, Reinartz J, Liebig T, Kühne D. Treatment of intracranial atherosclerotic stenoses with balloon dilatation and self-expanding stent deployment (WingSpan). Neuroradiology. 2005 Mar; 47(3): 222-8. Epub 2005 Mar 15.
  25. Higashida RT, Meyers PM, Connors JJ 3rd, Sacks D, Strother CM, Barr JD, Wojak JC, Duckwiler GR; American Society of Interventional and Therapeutic Neuroradiology; Society of Interventional Radiology; American Society of Neuroradiology.Intracranial angioplasty & 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. AJNR Am J Neuroradiol. 2009; 20:S312-S316. Accessed 06/15/12.
  26. Higashida RT, Myers PM. Intracranial angioplasty and stenting for cerebral atherosclerosis: new treatments for stroke are needed! Neuroradiology 2006; 48:367-372.
  27. Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14.
  28. Hurley, Dan. Intracranial Stenting's Risks Over Medical Therapy Prompt Halt of Major Trial. Neurology Today, 05 May 2011; Volume 11(9); p 10.
  29. Institute for Clinical Systems Improvement (ICSI). Technology Assessment Report: Carotid, vertebral, and intracranial artery angioplasty and stenting. Bloomington, MN: Institute for Clinical Systems Improvement (ICSI), June 2006.
  30. Intracranial Angioplasty and Stenting for Cerebral Atherosclerosis: A Position Statement of the American Society of Interventional and Therapeutic Neuroradiology, Society of Intervential Radiology, and the American Society of Neuroradiology. AJNR 26, October 2005.
  31. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. Jul 2014;45(7):2160-2236.
  32. Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke. 2006 Apr; 37(4):1016-20. Epub 2006 Feb 23.
  33. Marks MP. Is there a future for endovascular treatment of intracranial atherosclerotic disease after Stenting and Aggressive Medical Management for Preventing Recurrent Stroke and Intracranial Stenosis (SAMMPRIS)? Stroke. 2012 Feb;43(2):580-4. doi: 10.1161/STROKEAHA.111.645507. Epub 2012 Jan 12.
  34. McTaggart RA, Marks MP. The Case for Angioplasty in Patients with Symptomatic Intracranial Atherosclerosis. Front Neurol. 2014 Apr 11;5:36.
  35. Meyers PM, Schumacher HC, Higashida RT et al. Indications for the performance of intracranial endovascular neurointerventional procedures: a scientific statement from the American Heart Association Council on Cardiovascular Radiology and Intervention, Stroke Council, Council on Cardiovascular Surgery and Anesthesia, Interdisciplinary Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Circulation 2009; 119(16):2235-49.
  36. National Guideline Clearinghouse. Guideline Summary NGC-6659. (1) Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack. (2) Update to the AHA/ASA recommendations for the prevention of stroke in patients with stroke and transient ischemic attack. Summary completed by ECRI 04/13/06; updated by ECRI 07/27/10.
  37. Powers WJ, Derdeyn CP, Biller J, et al. 2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. Jun 29 2015.
  38. Siddiq F, Vazquez G, Memon MZ et al. Comparison of primary angioplasty with stent placement for treating symptomatic intracranial atherosclerotic diseases: a multicenter study. Stroke 2008; 39(9):2505-10.
  39. Simon CH Yu, et al. Angioplasty and stenting for intracranial atherosclerotic stenosis: position statement of the Hong Kong Society of Interventional and Therapeutic Neuroradiology. Hong Kong Med J 2013;19:69-73
  40. Wojak JC, Dunlap DC, Hargrave KR, DeAlvare LA, Culbertson HS, Connors JJ 3rd. Intracranial angioplasty and stenting: long-term results from a single center. AJNR Am J Neuroradiol. 2006 Oct;27(9):1882-92.
  41. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Wingspan Stent System with Gateway PTA Balloon Catheter - H050001. Rockville, MD: FDA; updated August 9, 2005.
  42. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health. Neurolink System - H010004. Rockville, MD: FDA; 2005.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/22/15.

GUIDELINE UPDATE INFORMATION:

07/15/08

New Medical Coverage Guideline.

09/15/09

Scheduled review; no change in position statement; references updated.

04/15/10

Revision to add rationale for position statement.

09/15/10

Scheduled review; position statement unchanged, references updated.

12/15/11

Reviewed with revision of Position Statement and Coding section; references updated, formatting changes.

08/15/12

Reviewed with no change to Position Statement; references updated.

09/15/13

Scheduled review; position statement unchanged; Program Exceptions section updated; references updated.

08/15/14

Annual review; position statement revised to address endovascular interventions for the treatment of acute ischemic stroke; MCG title revised; references updated.

04/15/15

Revision; position statement, title, description, coding, and references updated; formatting changes.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision; position statement, coding, and references updated; formatting changes.

01/01/16

Annual CPT/HCPCS update: codes 61645, 61650, 61651 added.

5. Is the request for the use of endovascular mechanical embolectomy, with an FDA approved device for the treatment of acute ischemic stroke as part of the treatment of acute ischemic stroke for a member who meets ALL of the following criteria:

• A demonstrated occlusion within the proximal intracranial anterior circulation (intracranial internal carotid artery, or M1 or M2 segments of the middle cerebral artery, or A1 or A2 segments of the anterior cerebral artery); AND

• Can receive endovascular mechanical embolectomy within 12 hours of symptom onset; AND

• Evidence of substantial and clinically significant neurological deficits (e.g. baseline (post-stroke) National Institutes of Health Stroke Scale (NIHSS) score); AND

• Evidence of salvageable brain tissue in the affected vascular territory (e.g. Alberta Stroke Program Early CT (ASPECTs) score); AND

• No evidence of intracranial hemorrhage or arterial dissection on CT or MRI imaging.

Date Printed: June 26, 2017: 01:18 AM