Electromagnetic Navigation Bronchoscopy

POLICY NUMBER

A.7.01.122

DESCRIPTION

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 and to allow fiducial markers placement.

Pulmonary Nodules

Pulmonary nodules are identified on plain chest radiographs or chest computed tomography scans. 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. 

Diagnosis

Lung cancer is the leading cause of cancer-related death in the U.S., with an estimated 226,650 new cases and 124,730 deaths due to the disease in 2025. The stage at which lung cancer is diagnosed has the greatest impact on prognosis. Localized disease confined to the primary site has a 64.7% relative 5-year survival, but accounts for only 25% of lung cancer cases at diagnosis. Mortality increases sharply with advancing stage and metastatic lung cancer has a relative 5-year survival of 9.7%. In addition to tumor stage, other factors such as age, sex, race/ethnicity, and performance status are independent prognostic factors for survival in patients with lung cancer. The average age at diagnosis is about 70 years and most people diagnosed with lung cancer are 65 years of age or older. The lifetime risk of lung cancer is approximately 1 in 17 for men and 1 in 18 for women, with an increased risk in people who smoke. Rates of lung cancer have been dropping among men over the past few decades, but only for about the last decade in women. Black men are about 12% more likely to develop lung cancer compared to White men, although Black men are less likely to develop small cell lung cancer when compared to White men. Among women, the rate of lung cancer is about 16% lower for Black versus White women.

The method used to diagnose lung cancer depends on a number of factors, including lesion size, shape, 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 <6 mm) are more difficult to evaluate than larger, centrally located lesions. There are several options for diagnosing malignant disease, but none of the methods are ideal. 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 evaluate pulmonary nodules. The sensitivity of flexible bronchoscopy for diagnosing bronchogenic carcinoma has been estimated at 88% 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% to 25% of patients, and 5% to 14% require insertion of a chest tube. Positron emission tomography scans are also highly sensitive for evaluating pulmonary nodules, yet may miss lesions less than 1 cm in size. A lung biopsy is the criterion standard for diagnosing pulmonary nodules, but is an invasive procedure.

Advances in technology may increase the yield of established diagnostic methods. Computed tomography 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 by radial probes, previously used in the perioperative staging of lung cancer, can also be used to locate and guide sampling of peripheral lesions. Endobronchial ultrasound is reported to increase the diagnostic yield of flexible bronchoscopy to at least 82%, regardless of lesion size or location.

Marker Placement

Another proposed enhancement to standard bronchoscopy is electromagnetic navigation bronchoscopy. Electromagnetic navigation bronchoscopy enhances 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 electromagnetic navigation bronchoscopy 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. Also, the guide catheter can be used to place fiducial markers. Markers are loaded in the proximal end of the catheter with a guidewire inserted through the catheter.

In 2004, the superDimension/Bronchus^TM inReach™ system (superDimension) was cleared for marketing by the U.S. 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 tracheobronchial 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). In 2019, a modified system, ILLUMISITE™ Platform, was also approved. The primary difference between the SuperDimension Navigation System and the ILLUMISITE Platform is the ability of the ILLUMISITE Platform to provide continuous positional feedback throughout the procedure (i.e. continuous guidance) via a sensor in the extended working channel. The system console hardware, software, and extended working channel were modified to incorporate the continuous guidance navigation feature.

In 2009, the ig4™ EndoBronchial system (Veran Medical) was cleared for marketing by the FDA through the 510(k) process. The system was considered to be substantially equivalent to the inReach system and is marketed as the SPiN Thoracic Navigation System™.

In April 2018, LungVision (Body Vision Medical) was cleared for marketing by the FDA through the 510(k) process (K172955). The FDA determined that this device was substantially equivalent to existing devices for use “segment previously acquired 3D CT [computed tomography] datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedure.” FDA product code: EOQ.

Several other navigation software-only systems have been cleared for marketing by the FDA through the 510(k) process. They include:

• In 2008: The LungPoint® virtual bronchoscopic navigation (VPN) system (Broncus Technologies).

• In 2010: The bf-NAVI VPN system (Emergo Group).

Two ENB systems are currently available, the SPiN Thoracic Navigation System (Veran Medical Technologies) and the superDimension™ navigation system (Medtronic).

POLICY

When flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective, electromagnetic navigation bronchoscopy (ENB) may be considered medically necessary to:

• establish a diagnosis of suspicious peripheral pulmonary lesion(s) or

• place fiducial markers within lung tumor(s) prior to treatment.

Electromagnetic navigation bronchoscopy is considered investigational for use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes as well as all other uses not covered above.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

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

Bronchoscopists performing electromagnetic navigation bronchoscopy (ENB) require specific training in the procedure.

Enlarged mediastinal nodes were an early indication for ENB which has been largely replaced by endobronchial ultrasound. One could consider it in the uncommon scenario in which linear endobronchial ultrasound is not available and the individual is having an ENB procedure for a peripheral nodule in any case.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

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 HISTORY

04/16/2010: 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 A.7.01.122 added. Investigative definition updated in Policy Guidelines section.

07/18/2016: Policy description updated regarding devices. Policy statements unchanged.

07/17/2017: Policy description updated regarding devices. Policy statements unchanged.

07/20/2018: Policy description updated regarding devices. Policy statements unchanged.

02/01/2021: Policy description updated regarding electromagnetic navigation bronchoscopy (ENB) systems. Added policy statement that when flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective, ENB may be considered medically necessary. Policy Guidelines updated to define medically necessary. Code Reference section updated to change the coding table from investigational to medically necessary and to add ICD-10 diagnosis codes C34.00 - C34.92, C78.00 - C78.01, D38.1, R91.1, and R91.8.

08/26/2021: Policy reviewed; no changes.

07/14/2022: Policy description updated regarding data for lung cancer. Policy statements unchanged.

08/02/2023: Policy description updated with new 2023 data. Policy statements unchanged. Policy Guidelines updated.

07/23/2024: Policy reviewed; no changes.

09/11/2025: Policy description updated regarding new 2025 data and devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.122

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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