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Peripheral lung lesions and solitary pulmonary nodules (SPN) (which are 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 percent for peripheral lesions.  For small peripheral lesions, less than 1.5 cm in diameter, the sensitivity may be as low as 10 percent.  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 percent.  A disadvantage of transthoracic needle aspiration is that a pneumothorax develops in 11 - 24 percent of patients and 5 - 14 percent 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 gold standard for diagnosing pulmonary nodules, but is an invasive procedure.

Recent advances in technology have led to enhancements that 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 percent, regardless of the size and location of the lesion.

Another proposed enhancement to standard bronchoscopy is Electromagnetic Navigation Bronchoscopy (ENB) using the InReach^TM System.  This technology uses CT scans to improve the ability of standard bronchoscopic procedures to reach lesions in the periphery of the lungs.  There are three phases of a procedure using the InReach^TM System, as follows:

1. Planning phase:  This consists of loading previously taken CT scans onto a laptop computer and using proprietary software to construct a three-dimensional image of the patient's lungs with anatomical landmarks identified.  The file containing this information is transferred to a computer on the InReach^TM computer console for use during the procedure;
2. Registration phase:  A steerable navigational catheter is placed through the working channel of a standard bronchoscope.  The anatomical landmarks identified in the planning phase are viewed on the three-dimensional image from phase one, and these virtual images are correlated with the actual image from the video-bronchoscope.  The steerable navigation catheter is placed at the same site as the virtual markers, and the position of each is marked using a foot petal;
3. Navigation phase:  The steerable navigation catheter is moved towards the target and the real-time location of the catheter's tip is displayed on the CT images.  When the navigation catheter reaches the target, it is locked in place and the working guide is retracted.  Once this occurs, any endoscopic tool can be inserted through the channel in the catheter to the target.  This includes insertion of a transbronchial forceps to biopsy the lesion.

Regulatory Status

In September 2004, the superDimension/Bronchus (superDimension Ltd, Herzliya, Israel) was cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process.  The FDA determined that this device was substantially equivalent to existing bronchoscopic devices.  It is indicated 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, does not make a diagnosis and is not approved for pediatric use.  The trade name of the device is the InReach^TM System; it is currently marketed in the United States by superDimension, Inc., Minneapolis, MN.

Electromagnetic navigation bronchoscopy is considered investigational for the placement of fiducial markers.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

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.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes        

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