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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.

02-99221-14

Original Effective Date: 03/15/09

Reviewed: 09/28/17

Revised: 10/15/17

Subject: Computer Assisted Surgical Navigation

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:

NOTE: This Medical Coverage Guideline addresses computer assisted surgical navigational procedures that do not have a specific Medical Coverage Guideline.

Computer assisted surgical navigation combines imaging with navigational computer software for displaying images, localizing surgical targets, facilitating view of non-visualized anatomy and aiding physicians in guiding endoscopic tools. Computer assisted surgical navigation use computer technology, which facilitate pre-surgical planning and for guiding and performing surgical procedures.

Computer assisted surgical navigational may be performed in addition to a primary procedure (e.g., biopsy, endoscopy, surgery). The U.S. Food and Drug Administration (FDA) have cleared through the 510(k) process several devices (e.g., superDimension/Bronchus, LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software, ig4™ System) for displaying images, placement of markers and for guiding endoscopic tools or catheters in the pulmonary tract.

Electromagnetic navigation bronchoscopy (ENB) combines simultaneous computed tomography (CT) virtual bronchoscopy with real-time fiberoptic bronchoscopy. ENB is intended to enhance standard bronchoscopy by providing a three-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. Electromagnetic navigation bronchoscopy during flexible bronchoscopy has been proposed as a method to further increase the diagnostic yield of bronchoscopy in the diagnosis of peripheral and mediastinal lung lesions and insertion of endoscopic tools (needle, brush, forceps) for lesion sampling, fiducial and dye marker placement prior to treatment.

For Computer assisted surgical navigational procedure for orthopedic procedures, please refer to MCG 02-20000-30, Computer Assisted Musculoskeletal Surgical Navigational Orthopedic Procedure Medical Coverage Guideline.

POSITION STATEMENT:

Computer assisted surgical navigational (e.g., skull base, maxillofacial, eye, auditory, lung [superDimension/Bronchus system, electromagnetic navigation bronchoscopy], cardiovascular, thoracic, abdominal, urinary, genital (male/female), spine), and placement of fiducial markers are considered not the generally accepted standard of medical practice and are considered experimental or investigational for all applications, evidence in the peer-reviewed medical literature is

insufficient to support the use of computer-assisted surgical navigational for these applications.

BILLING/CODING INFORMATION:

There is no specific code for computer assisted surgical navigation. Computer assisted surgical navigation may be reported with an unlisted or unspecified procedure code.

CPT Coding:

31627

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with computer-assisted, image-guided navigation (List separately in addition to code for primary procedure[s]) (investigational)

REIMBURSEMENT INFORMATION:

The use of device(s) (e.g., surgical, software, other [specified and unspecified]) in conjunction with or without computer assisted surgical navigational procedures is considered an integral part of the primary surgical procedure and is not separately reimbursable.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Computer Assisted Musculoskeletal Surgical Navigational Orthopedic Procedure, 02-20000-30

OTHER:

Other names used to report computer assisted surgical navigational procedures:

Computer aided surgery

Computer assisted intervention
Computer assisted surgery
Electromagnetic navigation bronchoscopy (ENB)
Image guided surgery
Surgical navigation

REFERENCES:

  1. AI-Zubaidi N, Soubani AO. Advances in diagnostic interventional pulmonary. Avicenna Journal Medicine 2015; 5(3): 57-66.
  2. Anatham D, Feller-Kopman D, Shanmugham LN et al. Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors. Chest 2007; 132:930-935.
  3. Asano F, Matsuno Y, Shinagawa N et al. A virtual bronchoscopic navigation system for pulmonary peripheral lesions. Chest 2006; 130:559-566.
  4. Baumhauer M, Feuerstein M, Meinzet HP et al. Navigation in endoscopic soft tissue surgery: perspectives and limitations. Journal of Endourology 2008; 22(4): 751-66.
  5. Blue Cross Blue Shield Electromagnetic Navigation Bronchoscopy Medical Policy 7.01.122, 06/17.
  6. Dale CR, Madtes DK, Fan VS. Navigational bronchoscopy with biopsy versus CT-guided biopsy for the diagnosis of a solitary pulmonary nodule: a cost-consequences analysis. Journal Bronchology Intervention Pulmonology 2013; 19(4): 294-303.
  7. Detterbeck FC, Lewis SZ, Diekemper R et al. Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013; 143(5): 7S-37S.
  8. Du Rand IA, Barber PV, Goldring J, et al. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66(Suppl 3): iii1-21.
  9. Eberhardt R, Anantham D, Herth F et al. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest 2007; 131: 1800-1805.
  10. Eberhardt R, Anantham D, Ernst A et al. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. American Journal of Respiratory and Critical Care Medicine 2007; 176: 37-41.
  11. Fengqiang L, Jiadong Q, Yi L. Computer-assisted stereotactic neurosurgery with framework neurosurgery. Clinical Neurology and Neurosurgery 2008: 110(7): 696-700.
  12. Gildea TR, Mazzone PJ, Karnak D et al Electromagnetic navigation diagnostic bronchoscopy: a prospective study. American Journal of Respiratory and Critical Care Medicine 2006; 176: 982-989.
  13. Gould MK, Donington J, Lynch WR et al. Evaluation of individuals with pulmonary nodules: When is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2013; 143(5 Suppl.): e93S-e120S.
  14. inReach-superDimension inResearch™ System, 2008.
  15. Kalfas IH. Image-guided spinal navigation: application to spinal metastases. Neurosurgical Focus 2001; 11(6): 1-10.
  16. Khandhar SJ, Bowling MR, Flandes J. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulmonary Medicine 2017; 17(1):59.
  17. Lamprecht B, Porsch P, Wegleitner B et al. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respiratory Medicine 2012; 106(5): 710-715.
  18. Leong S, Ju H, Marshall H et al. Electromagnetic navigation bronchoscopy: A descriptive analysis. Journal of Thoracic Disease 2012; 1(4): 173-185.
  19. Loo FL, Halligan AM, Port JL et al. The emerging technique of electromagnetic navigation bronchoscopy-guided fine-needle aspiration of peripheral lung lesions: promising results in 50 lesions. Cancer Cytopathology 2014; 122(3): 191-199.
  20. Makris D, Scherpereel A, Leroy S et al. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. European Respiratory Journal 2007; 29(6): 1187-1192.
  21. Mezger U, Jendrewaki C, Barteis M. Navigation in surgery. Longenbeck’s Archives of Surgery 2013; 398:501-514.
  22. Muñoz-Largacha JA, Litle VR, Fernando HC. Navigation bronchoscopy for diagnosis and small nodule location. Journal of Thoracic Disease 2017 Mar; 9(Suppl 2):S98-S103.
  23. Rivera MP, Mehta AC, Wahidi MM. Establishing the Diagnosis of Lung Cancer, Diagnosis and Management of Lung Cancer,3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2013; 143 (5)(Suppl): e143S-e165S.
  24. National Comprehensive Cancer Network® NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)® Non-Small Cell Lung Cancer Version 6.2017.
  25. Ozgul G, Cetinkaya E, Ozgul MA. Efficacy and safety of electromagnetic navigation bronchoscopy with or without radial endobronchial ultrasound for peripheral lung lesions. Endoscopic Ultrasound 2016; 5(3): 189-95.
  26. Port J, Harrison S. Electromagnetic navigational bronchoscopy. Seminars in Interventional Radiology 2013; 30(2): 128-132.
  27. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed.: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013; 143(5Suppl): e142S-e165S.
  28. Rivera MP, Mehta AC; American College of Chest Physicians. Initial diagnosis of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007; 132(3 Suppl): 131S-148S.
  29. Schulz C, Waldeck S, Mauer UM. Intraoperative image guidance in neurosurgery: development, current indications, and future trends. 2012. Radiology Research and Practice 2012; 2012:197364.
  30. Schramm A, Suarez-Cunqueiro MM, Barth EL et al. Computer-assisted navigation in carniomaxillofacial tumors. Journal of Carniofacial Surgery 2008:19(4): 1067-1074.
  31. Schwartz Y, Greif J, Becker H et al. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest 2006; 129; 988-994.
  32. Staecker H, O’Malley BW, Eisenberg H et al. Use of the LandmarX™ surgical navigational system in lateral skull base and temporal bone surgery. Skull Base 2001; 11(4): 245-255.
  33. U.S. Food and Drug Administration (FDA) 510(k) K091934 Premarket Notification Database-ig4™ Endobronchial, 12/02/09.
  34. U.S. Food and Drug Administration (FDA) 510(k) K042438 Premarket Notification Database-Superdimension/Bronchus, 11/08/04.
  35. U.S. Food and Drug Administration (FDA) 510(k) K091160 Premarket Notification Database- LungPoint™Virtual Bronchoscopic Navigation (VBN) Software, 05/05/09.
  36. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest 2012; 142(2): 385-393.
  37. Weiser TS, Hyman K, Yun J et al. Electromagnetic navigational bronchoscopy: a surgeon’s perspective. The Annals of Thoracic Surgery 2008; 85(2): S797-S801.
  38. Wiener RS, Schwartz LM, Woloshin S et al. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Population-based risk of complications following transthoracic needle lung biopsy of a pulmonary nodule Annals of Internal Medicine 2011; 155(3): 137-144.
  39. Zhang W, Chen S, Dong X et al. Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules. Journal of Thoracic Disease 2015; 7(5): 799-809.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/28/17.

GUIDELINE UPDATE INFORMATION:

03/15/09

New Medical Coverage Guideline.

01/01/10

Annual HCPCS coding update: added 31627, and updated references.

03/15/10

Scheduled review. No change in position statement (experimental or investigational), and updated references.

01/01/11

Annual HCPCS coding update: added 61781, 61782 and 61783.

01/15/11

Deleted codes 61781, 61782 and 61783.

03/15/11

Annual review: position statements maintained, updated description; added FDA information regarding superDimension/Bronchus System and LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software, added “and placement of fiducial markers” to position statement, revised reimbursement information; added software and wording “or without”, added Medicare Advantage program exception, and updated references.

02/15/13

Updated Medicare Advantage products program exception.

05/11/14

Revision: Program Exceptions section updated.

09/15/16

Review; no change to position statement. Removed “procedures and devices” from subject. Updated references.

10/15/17

Review; no change in position statement. Updated references.

Date Printed: December 17, 2017: 04:25 PM