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Electromagnetic navigation bronchoscopy (ENB) is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs, so that suspicious lesions can be biopsied to allow fiducial markers placement.
Pulmonary nodules are identified on plain chest radiographs or chest computed tomography (CT) scans. (Note: Screening for lung cancer and whole-body CT scans for screening are considered investigational.) Although most nodules are benign, some are cancerous, and early diagnosis of lung cancer is desirable because of the poor prognosis when it is diagnosed later. The method used to diagnose lung cancer depends on a number of factors, including lesion size and location, as well as the clinical history and status of the patient.
Peripheral lung lesions and solitary pulmonary nodules (most often defined as asymptomatic nodules less than 6mm) are more difficult to evaluate than larger, centrally located lesions. There are several options for diagnosing them; none of the methods are ideal for safely and accurately diagnosing malignant disease. Sputum cytology is the least invasive approach. Reported sensitivity rates are relatively low and vary widely across studies; sensitivity is lower for peripheral lesions. Sputum cytology, however, has a high specificity, and a positive test may obviate the need for more invasive testing. Flexible bronchoscopy, a minimally invasive procedure, is an established approach to evaluating pulmonary nodules. The sensitivity of flexible bronchoscopy for diagnosing bronchogenic carcinoma has been estimated at 88 percent for central lesions and 78% for peripheral lesions. For small peripheral lesions, less than 1.5 cm in diameter, the sensitivity may be as low as 10%. The diagnostic accuracy of transthoracic needle aspiration for solitary pulmonary nodules tends to be higher than that of bronchoscopy. The sensitivity and specificity are both approximately 94%. A disadvantage of transthoracic needle aspiration is that a pneumothorax develops in 11 - 24% of patients, and 5 - 14% require insertion of a chest tube. PET scans are also highly sensitive for evaluating pulmonary nodules, yet may miss small lesions less than 1 cm in size. Lung biopsy is the criterion standard for diagnosing pulmonary nodules, but is an invasive procedure.
Recent advances in technology may increase the yield of established diagnostic methods. CT scanning equipment can be used to guide bronchoscopy and bronchoscopic transbronchial needle biopsy, but have the disadvantage of exposing the patient and staff to radiation. Endobronchial ultrasound (EBUS) by radial probes, previously used in the perioperative staging of lung cancer, can also be used to locate and guide sampling of peripheral lesions. EBUS is reported to increase the diagnostic yield of flexible bronchoscopy to at least 82%, regardless of lesion size or location.
Another proposed enhancement to standard bronchoscopy is electromagnetic navigation bronchoscopy (ENB). ENB is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy. The purpose of ENB is to allow navigation to distal regions of the lungs. Once the navigation catheter is in place, any endoscopic tool can be inserted through the channel in the catheter to the target. This includes insertion of transbronchial forceps to biopsy the lesion. In addition, the guide catheter can be used to place fiducial markers. Markers are loaded in the proximal end of the catheter with a guide wire inserted through the catheter.
In September 2004, the superDimension/BronchusTM InReach™ system (superDimension, Herzliya, Israel) was cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. The system includes planning and navigation software, a disposable extended working channel, and a disposable steerable guide. The FDA-cleared indication is for displaying images of the tracheopbronchial tree that aids physicians in guiding endoscopic tools in the pulmonary tract. The device is not intended as an endoscopic tool; it does not make a diagnosis; and is not approved for pediatric use. As of June 2016, the current version of the product is the Medtronic SuperDimension Navigation System (Medtronic, Minneapolis, MN).
In December 2009, the ig4™ EndoBronchial system (Veran Medical; St. Louis, MO) was cleared for marketing by FDA through the 510(k) process. The system was considered to be substantially equivalent to the InReach system and is marketed as the SPiN™ Drive system.
Several additional navigation software-only systems have been cleared for marketing by FDA through the 510(k) process. They include:
POLICYElectromagnetic navigation bronchoscopy is considered investigational for use with flexible bronchoscopy for the diagnosis of pulmonary lesions and mediastinal lymph nodes.
Electromagnetic navigation bronchoscopy is considered investigational for the placement of fiducial markers.
POLICY EXCEPTIONSFederal Employee Program may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY04/16/2010: New policy added.
04/25/2011: Policy statement revised to state that electromagnetic navigation bronchoscopy is considered investigational for the placement of fiducial markers.
03/02/2012: Policy reviewed; no changes.
04/04/2013: Policy reviewed; no changes.
03/12/2014: Policy reviewed; description updated. Policy statement unchanged.
10/17/2014: Policy reviewed; description updated. Policy statement unchanged.
02/10/2015: Policy reviewed; description updated regarding devices. Policy statement unchanged.
07/20/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
07/18/2016: Policy description updated regarding devices. Policy statements unchanged.
SOURCESBlue Cross Blue Shield Association Policy # 7.01.122
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.