Electromagnetic navigation bronchoscopy (ENB), also known as virtual bronchoscopic navigation (VBN), is an enhancement to standard bronchoscopy that provides a three-dimensional roadmap of the lungs and real-time navigation to aid the physician in guiding endoscopic tools within the pulmonary tract. Information from a steerable bronchoscope probe allows transbronchial forceps to biopsy suspicious lesion(s). The purpose of ENB (e.g., inReach™ ig4™ EndoBronchial system, LungPoint™, SPiN Thoracic Navigation System™), is to allow navigation to the distal one third regions of the lungs. Imaging (PET or CT) is useful before selecting a biopsy site so that one that will confer the highest stage of lung cancer will be chosen.
ENB has also been proposed as a method for fiducial marker placement prior to radiotherapy. Fiducial markers are gold seeds or stainless steel screws that are implanted around a soft tissue tumor to act as a radiologic landmark, to define the target lesion's position with millimeter precision. However, data on the safety and effectiveness of using ENB for fiducial marker placement is lacking.
Electromagnetic navigation bronchoscopy for use with a flexible bronchoscopy for the diagnosis of pulmonary lesions and mediastinal lymph nodes is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Electromagnetic navigation bronchoscopy for the placement of pulmonary fiducial markers is considered investigational.
Electromagnetic navigation bronchoscopy for use with a flexible bronchoscope is considered medically appropriate if ALL of the following criteria have been met:
Chest computed tomography (CT) scan shows solid nodule lesion(s) suspicious for lung cancer
Lesion is located either in the mediastinal lymph node or outer one-third of the lungs
Lesion, or largest of several lesions, measures 8mm or more
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
American College of Chest Physicians. (May, 2013). Establishing the diagnosis of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Retrieved December 8, 2015 from http://www.chestnet.org/Guidelines-and-Resources/CHEST-Guideline-Topic-Areas/Thoracic-Oncology.
BlueCross BlueShield Association. Evidence Positioning System. (6:2018). Electromagnetic navigation bronchoscopy (7.01.122). Retrieved December 10, 2018 from https://www.evidencepositioningsystem.com/. (22 articles and/or guidelines reviewed)
Diken, Ӧ. E., Karnak, D., Çiledağ, A., Ceyhan, K., Atasoy, Ç., Akyar, S., & Kayacan, O. (2015). Electromagnetic navigation-guided TBNA vs conventional TBNA in the diagnosis of mediastinal lymphadenopathy. The Clinical Respiratory Journal, 9 (2), 214-220. Abstract retrieved December 8, 2015 from PubMed database.
Gex, G., Pralong, J., Combescure, C., Seijo, L., Rochat, T., & Soccal, P. (2014) Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and metaanalysis. Respiration, 87 (2), 165-76. Abstract retrieved January 26, 2018 from PubMed database.
Hagmeyer, L., Priegnitz, C., Kocher, M., Schilcher, B., Budach, W., Treml, M. et al. (2016). Clinical Respiratory Journal, 10 (3), 291-297. Abstract retrieved January 26, 2018 from PubMed database.
Khandhar, S., Bowling, M., Flandes, J., Gildea, T., Hood, K., Krimsky, W., et al. (2017) Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulmonary Medicine, 17 (59) e-published ahead of print. (Level 2 evidence)
Loo, F., Halligan, A., Port, J., & Hoda, R. (2014). The emerging technique of electromagnetic navigation bronchoscopy-guided fine-needle aspiration of peripheral lung lesions. Cancer Cytopathology, 122, 191-199.
National Comprehensive Cancer Network (2018, November). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-small cell lung cancer v2.2019. Retrieved December 10, 2018 from the National Comprehensive Cancer Network.
U.S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. 510(k) Premarket notification database K091160. Retrieved March 18, 2011 from http://www.fda.gov.
U.S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. 510(k) Premarket notification database K091934. Retrieved March 18, 2011 from http://www.fda.gov.
U.S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. 510(k) Premarket notification database K092365. Retrieved March 18, 2011 from http://www.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2014, December; last update search November 2017). Virtual bronchoscopic navigation for evaluation of peripheral pulmonary lesions. Retrieved January 26, 2018 from www.hayesinc.com. (33 articles and/or guidelines reviewed)
Zhang, W., Chen, S., Dong, X., & Lei, P. (2015). Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules. Journal of Thoracic Disease, 7 (5), 799-809. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 9/11/2011
MOST RECENT REVIEW DATE: 1/10/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.