DESCRIPTION
Electromagnetic navigation bronchoscopy is intended to enhance the standard bronchoscopy by providing a three-dimensional roadmap of the lungs and real-time information about the position of a steerable probe that allows transbronchial forceps to biopsy lesion(s) and to allow for placement of fiducial markers.
POLICY
Electromagnetic navigation bronchoscopy for use with a flexible bronchoscopy for the diagnosis of pulmonary lesions and mediastinal lymph nodes is considered investigational.
Electromagnetic navigation bronchoscopy for the placement of fiducial markers is considered investigational.
IMPORTANT REMINDER
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.
ADDITIONAL INFORMATION
Since the lack of well-designed randomized controlled trials and published studies there is little evidence regarding the safety and efficacy of the electromagnetic navigation bronchoscopy technology, either used for the diagnosis of pulmonary lesions and mediastinal lymph nodes or for fiducial marker placement.
SOURCES
Alberts, W. M., & American College of Chest Physicians. (2007). Diagnosis and management of lung cancer executive summary: ACCP evidence-based clinical practice guidelines (2nd Edition). Chest, 132 (3 Suppl.), 1S-19S.
Anantham, D., Feller-Kopman, D., Shanmugham, L. N., Berman, S. M., DeCamp, M. M., Gangadharan, S. P., et al. (2007). Electromagnetic navigation bronchoscopy-guided fiducial placement for robotic stereotactic radiosurgery of lung tumors: A feasibility study. Chest, 132 (3), 930-935. (Level 3 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). Electromagnetic navigation bronchoscopy (7.01.122). Retrieved April 14, 2011 from BlueWeb. (14 articles and/or guidelines reviewed)
Eberhardt, R., Anantham, D., Ernst, A., Feller-Kopman, D., & Herth, F. (2007). Multimodality bronchoscopic diagnosis of peripheral lung lesions: A randomized controlled trial. American Journal of Respiratory and Critical Care Medicine, 176 (1), 36-41. (Level 2 Evidence - Industry sponsored)
Eberhardt, R., Anantham, D., Herth, F., Feller-Kopman, D. & Ernst, A. (2007). Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest, 131 (6), 1800-1805.
Eberhardt, R., Morgan, R. K., Ernst, A, Bever, T., & Herth, F. J. (2010). Comparison of suction catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by electromagnetic navigational bronchoscopy. Respiration, 79 (1), 54-60. (Level 3 Evidence - Industry sponsored)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2010, September). Electromagnetic navigation (i-logic System) during flexible bronchoscopy to aid diagnosis of peripheral lung lesions. Retrieved March 17, 2011 from ECRI Institute. (36 articles and/or guidelines reviewed)
Gildea, T. R., Mazzone, P. J., Karnak, D., Meziane, M., & Mehta, A. C. (2006). Electromagnetic navigation diagnostic bronchoscopy: A prospective study. American Journal of Respiratory and Critical Care Medicine, 174 (9), 982-989. (Level 3 Evidence - Industry sponsored)
Makris, D., & Gourgoulianis, K. I. (2008). Electromagnetic navigation diagnostic bronchoscopy and transbronchial biopsy. Chest, 133 (3), 829-830.
Makris, D., Scherpereel, A., Leroy, S., Bouchindhomme, B., Faivre, J. B., Remy, J., et al. (2007). Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. The European Respiratory Journal, 29 (6), 1187-1192. (Level 3 Evidence - Independent study)
Schwarz, Y. (2010). Electromagnetic navigation. Clinics in Chest Medicine, 31 (1), 65-73.
Seijo, L., de Torres, J., Lozano, M., Bastarrika, G., Alcaide, A., Lacunza, M., et al. (2010). Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: Results from a prospective study. Chest, 138 (6), 1316-1321. (Level 3 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2009, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091934. Retrieved March 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091934.pdf.
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.accessdata.fda.gov/cdrh_docs/pdf9/K091160.pdf.
U. S. Food and Drug Administration. (2009, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092365. Retrieved March 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092365.pdf.
U. S. Food and Drug Administration. (2010, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093810. Retrieved March 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093810.pdf.
U. S. Food and Drug Administration. (2011, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K110093. Retrieved March 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110093.pdf.
ORIGINAL EFFECTIVE DATE: 9/11/2011
MOST RECENT REVIEW DATE: 9/11/2011
ID_BA
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