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Date Printed: June 28, 2017: 11:50 PM

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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.

02-33000-28

Original Effective Date: 03/15/03

Reviewed: 03/26/15

Revised: 04/15/15

Subject: Extracranial Carotid Angioplasty/Stenting

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 Updates  
           

DESCRIPTION:

Carotid angioplasty, with or without associated stenting, has been investigated as a minimally invasive alternative to open carotid endarterectomy (CEA), which is currently considered the gold standard of treatment for patients with significantly obstructing carotid atherosclerosis (stenosis). Carotid angioplasty and stenting (CAS) involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices. The procedure is most often performed through the femoral artery, but a transcervical approach can also be used to avoid traversing the aortic arch. The procedure typically takes 20 to 40 minutes. Interventionalists almost uniformly use an embolic protection device (EPD) designed to reduce the risk of stroke caused by thromboembolic material dislodged during CAS. Embolic protection devices can be deployed proximally (with flow reversal) or distally (using a filter). Carotid angioplasty is rarely performed without stent placement.

Advantages of CAS, in comparison to carotid endarterectomy, include the following:

The U.S. Food and Drug Administration (FDA) has approved several carotid artery stents and EPDs from various manufactures. Each FDA-approved carotid stent system is indicated for combined use with an EPD to reduce risk of stroke in patients considered to be at increased risk for periprocedural complications from CEA who are symptomatic with greater than 50% stenosis, or asymptomatic with greater than 80% stenosis-degree of stenosis being assessed by ultrasound or angiogram with computed tomography (CT) angiography also sometimes used. Patients are considered at increased risk for complications during CEA if affected by any item from a list of anatomic features and comorbid conditions included in each stent system’s Information for Prescribers.

POSITION STATEMENT:

Carotid angioplasty with associated stenting and embolic protection meets the definition of medical necessity when ALL of the following criteria are met:

Carotid angioplasty with or without associated stenting and embolic protection is considered experimental or investigational for all other indications, including but not limited to, members with carotid stenosis who are suitable candidates for CEA or members with carotid artery dissection. There is insufficient clinical evidence to permit conclusions on net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

37215

Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection

37216

Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; without distal embolic protection

37217

Transcatheter placement of an intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment, open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation

37218

Transcatheter placement of intravascular stent(s), intrathoracic common carotid artery or innominate artery, open or percutaneous antegrade approach, including angioplasty, when performed, and radiological supervision and interpretation

REIMBURSEMENT INFORMATION:

CPT codes 37215 and 37216 include all ipsilateral selective carotid catherization, all diagnostic imaging for ipsilateral, cervical and cerebral carotid arteriography, and all related radiological supervision and interpretation.

CPT code 37217 indicates the procedure is performed trancervically or by retrograde approach, but is considered carotid stenting.

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 (20.7) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other Terms used to describe these procedures:

Angioplasty, carotid artery
Carotid Artery, angioplasty and stenting
Percutaneous transluminal angioplasty, carotid artery
Stents, carotid artery

REFERENCES:

  1. American College of Cardiology Foundation; American Society of Interventional & Therapeutic Neuroradiology; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology, Bates ER, Babb JD, Casey DE Jr, Cates CU, Duckwiler GR, Feldman TE, Gray WA, Ouriel K, Peterson ED, Rosenfield K, Rundback JH, Safian RD, Sloan MA, White CJ. ACCF/SCAI/SVMB/SIR/ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting). J Am Coll Cardiol. 2007 Jan 2; 49(1): 126-70.
  2. Ammar AD. Surgery versus stenting: how medical device makers influence patient care. Stroke. 12/04; 35(12): 2759-60.
  3. 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.
  4. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 7.01.68 Extracranial Carotid Angioplasty/Stenting, 03/15.
  5. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation. TEC Assessments 2009; Volume 24, Tab 12.
  6. Blue Cross Blue Shield Association “Angioplasty and Stenting of the Cervical Carotid Artery with Distal Embolic Protection of the Cerebral Circulation” TEC Assessment 2005; Volume 19, No. 15.
  7. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Carotid stenting for the treatment of carotid artery stenosis. Ottawa, ON: CCOHTA; 2002.
  8. CaRESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I clinical trial: 1-year results. J Vasc Surg. 08/05; 42(2): 213-9.
  9. Centers for Medicare & Medicaid Services (CMS), Decision Memo for Percutaneous Transluminal Angioplasty of the Carotid Artery Concurrent with Stenting (CAG-00085R6), 10/14/08.
  10. Centers for Medicare & Medicaid Services (CMS), NCD for Percutaneous Transluminal Angioplasty (20.7), 03/13; accessed at cms.gov 02/17/15.
  11. Chaturvedi S, Bruno A, Feasby T, Holloway R, Benavente O, Cohen SN, Cote R, Hess D, Saver J, Spence JD, Stern B, Wilterdink J; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Carotid endarterectomy-an evidence-based review: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 09/27/05; 65(6): 794-801.
  12. Chaturvedi S; Fessler R. “Angioplasty and stenting for stroke prevention: good questions that need answers”. Neurology 2002; 59(5): 664-8.
  13. ClinicalTrails.gov, Carotid Angioplasty and Stenting Versus Endarterectomy (ACT I), sponsored by Abbott Vascular, accessed on 03/11/11.
  14. ClinicalTrials.gov, A Randomized Evaluation of Short Term and Long Term Outcome After Endovascular Repair by Stenting of Carotid Artery Stenosis in Patients with Severe (70% and Higher) Asymptomatic Carotid Stenosis, sponsored by Carmel Medical Center, accessed 03/11/11.
  15. ClinicalTrials.gov, Carotid Endarterectomy vs. Carotid Artery Stenting in Asymptomatic Patients (ACST-2), sponsored by St. George’s, University of London, accessed 03/11/11.
  16. ClinicalTrials.gov, Carotid With Bivalirudin Angioplasty (COBRA), sponsored by Medstar Research Institute, accessed 03/19/09.
  17. ClinicalTrials.gov, Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty, sponsored by Columbia University, accessed 03/19/09.
  18. ClinicalTrials.gov, Second Phase of “Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events”, sponsored by Abbot Vascular, accessed 03/19/09.
  19. ClinicalTrials.gov, Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy (SAPPHIRE Worldwide), sponsored by Cordis Corporation, accessed 03/19/09.
  20. ClinicalTrials.gov, Stenting vs. Best Medical Treatment of Asymptomatic High Grade Artery Stenosis – a Randomized Controlled Trial, sponsored by Vienna General Hospital, accessed 03/11/11.
  21. Connors JJ 3rd, Sacks D, Furlan AJ, Selman WR, Russell EJ, Stieg PE, Hadley MN, Wojak JC, Koroshetz WJ, Heros RC, Strother CM, Duckwiler GR, Durham JD, Tomsick TO, Rosenwasser RH, McDougall CG, Haughton VM, Derdeyn CP, Wechsler LR, Hudgins PA, Alberts MJ, Raabe RD, Gomez CR, Cawley CM 3rd, Krol KL, Futrell N, Hauser RA, Frank JI; American Academy of Neurology; American Association of Neurological Surgeons; American Society of Interventional and Therapeutic Neuroradiology; American Society of Neuroradiology; Congress of Neurological Surgeons; AANS/CNS Cerebrovascular Section; Society of Interventional Radiology; NeuroVascular Coalition Writing Group. Training, competency, and credentialing standards for diagnostic cervicocerebral angiography, carotid stenting, and cerebrovascular intervention: a joint statement from the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, the AANS/CNS Cerebrovascular Section, and the Society of Interventional Radiology. Neurology. 01/25/05; 64(2): 190-8.
  22. Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for vertebral artery stenosis. The Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD000516. DOI: 10.1002/14651858.CD000516.pub2.
  23. Coward LJ, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD000515. DOI: 10.1002/14651858.CD000515.pub2.
  24. Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke 04/05; 36(4): 905-11.
  25. Creager MA, Goldstone J, Hirshfeld JW Jr, Kazmers A, Kent KC, Lorell BH, Olin JW, Pauly RR, Rosenfield K, Roubin GS, Sicard GA, White CJ, Merli FG, Rodger GP, Tracy CM, Weitz HH; American College of Cardiology; American Heart Association; American College of Physicians Task Force on Clinical Competence; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular surgery. ACC/ACP/SCAI/SVMB/SVS Clinical Competence Statement on vascular medicine and catheter-based peripheral vascular interventions. Report of the American College of Cardiology/American Heart Association/American College of Physicians Task Force on Clinical Competence (ACC/ACP/SCAI/SVMB/SVS Writing Committee to develop a clinical competence statement on peripheral vascular disease). Am Coll Cardiol. 08/18/04; 44(4): 941-57.
  26. ECRI, Health Technology Forecast™ – Carotid stenting with embolic protection for carotid artery stenosis, (09/2005).
  27. ECRI. HTAIS Hotline Service. Combined Angioplasty and Stenting for Intracranial Atherosclerosis. Updated 07/14/06.
  28. Hayes, Inc. HAYES Medical Technology Directory. “Carotid Artery Stenting for the Treatment of Carotid Artery Stenosis” (CARO0102.22) 03/09/04. Update performed 04/12/06.
  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. Jim J, Rubin BG, et al, Society for Vascular Surgery (SVS) Vascular Registry evaluation of comparative effectiveness of carotid revascularization procedures stratified by Medicare age. J Vasc Surg 2012; 55:1313-21; accessed at gefaesse.at 02/18/15.
  31. Levy EI, Mocco J, Samuelson RM, et al, Optimal Treatment of Carotid Artery Disease, J Am Coll Cardiol 2008; 51; 979-985, accessed at content.onlinejacc.org on 03/19/09.
  32. Mantese VA, et al, The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST): Stenting Versus Carotid Endarterectomy for Carotid Disease, Stroke 2010; 41;531-534.
  33. McCabe DJ, Pereira AC, Clifton A, Bland JM, Brown MM; CAVATAS Investigators. Restenosis after carotid angioplasty, stenting, or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). Stroke. 02/05; 36(2): 281-6.
  34. Mukherjee D, Yadav JS. “Percutaneous treatment of carotid stenosis”. Cardiology Clinics 2002; 20(4).
  35. Mullenix PS, Andersen CA, et al. “Carotid endarterectomy remains the gold standard”. Am J Surg 2002; 183(5): 580-3.
  36. National Guideline Clearinghouse, Coronary Heart Disease (CHD): Symptoms, Diagnosis and Treatment, 03/08.
  37. National Guideline Clearinghouse, Secondary Prevention In: Clinical Guidelines for Acute Stroke Management, 10/07.
  38. National Institute for Clinical Excellence (NICE). Carotid artery stent placement for carotid stenosis. 08/04.
  39. Rhee-Moore SJ, DeRubertis BG, Lam RC, et al, Periprocedural Complication Rates are Equivalent Between Symptomatic and Asymptomatic Patients Undergoing Carotid Angioplasty and Stenting, Ann Vasc Surg. 2008 Mar; 22(2): 233-7.
  40. 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; accessed at ahajournals.org 02/18/15.
  41. Sidawy AN, Zwolak RM, White RA, et al, Risk-Adjusted 30-Day Outcomes of Carotid Stenting and Endarterectomy: Results from the SVS Vascular Registry, J Vasc Surg. 2009 Jan; 49(1): 71-9.
  42. Tice JA, Carotid Artery Stenting in Patients with Carotid Artery Stenosis, California Technology Assessment Forum, 10/13/10.
  43. U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. Summary of Safety and Effectiveness Data, The ACCULINK™ Carotid Stent System and the RX ACCULINK™ Carotid Stent System. PMA # 9040012. 08/30/04.
  44. Wholey MH, Barbato JE, Al-Khoury GE, Treatment of Asymptomatic Carotid Disease with Stenting: Pro, Semin Vasc Surg. 2008 Jun; 21(2): 95-9.
  45. Yadav, JS, Wholey MH, et al. “Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients”. N Engl J Med 2004; 351: 1493-501.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/26/15.

GUIDELINE UPDATE INFORMATION:

03/15/03

New Medical Coverage Guideline.

03/15/04

Review and revision; consisting of updated references.

01/01/05

Annual HCPCS update; consisting of deletion of 0005T, 0006T and 0007T and addition of 0075T, 0076T, 37215 and 37216.

05/15/05

Review and revision; consisting of updated references and MCG name change.

03/15/06

Review and revision; consisting of updated references and addition of coverage criteria.

08/15/07

Review and revision; consisting of updated references and reformatted guideline.

05/15/09

Biennial review: MCG title, description section, position statement, reimbursement information and updated references.

05/15/11

Biennial review; position statement maintained, formatting changes, references updated.

05/15/14

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

01/01/15

Annual HCPCS update. Added code 37218; revised codes 37215-37217, 0075T-0076T.

04/15/15

Review; position statements maintained; coding (codes 0075T-0076T removed) and references updated.

Date Printed: June 28, 2017: 11:50 PM