203 Form

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Medical Policy Electromagnetic Navigation Bronchoscopy Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 203

BCBSA Reference Number: 7.01.122 (For Plan internal use only) NCD/LCD: N/A Related Policies
• Cerebrospinal Fluid and Urinary Biomarkers of Alzheimer Disease, #581 • Endobronchial Ultrasound for Diagnosis and Staging of Lung Cancer, #715 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

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.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required.

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Medicare PPO BlueSM Prior authorization is not required.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes

CPT codes:

Code Description 31626 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with placement of fiducial markers, single or multiple 31627 Bronchoscopy, rigid or flexible, including fluoroscopic guidance when performed; with computer-assisted, image-guided navigation

The following ICD Diagnosis Codes are considered medically necessary when submitted with the CPT codes above if medical necessity criteria are met:

ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description C34.00 Malignant neoplasm of unspecified main bronchus C34.01 Malignant neoplasm of right main bronchus C34.02 Malignant neoplasm of left main bronchus C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung C34.12 Malignant neoplasm of upper lobe, left bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung C34.31 Malignant neoplasm of lower lobe, right bronchus or lung C34.32 Malignant neoplasm of lower lobe, left bronchus or lung C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung C34.91 Malignant neoplasm of unspecified part of right bronchus or lung C34.92 Malignant neoplasm of unspecified part of left bronchus or lung J98.4 Other disorders of lung R91.1 Solitary pulmonary nodule R91.8 Other nonspecific abnormal finding of lung field Description

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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 2025.1, 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. 2, Mortality increases sharply with advancing stage and metastatic lung cancer has a relative 5-year survival of 9.7%.1, 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.1, 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.2, 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.1, 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 (<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.3,4,5, 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.3, Marker Placement Another proposed enhancement to standard bronchoscopy is electromagnetic navigation bronchoscopy (ENB). 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 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. 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.

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Summary 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. Summary of Evidence For individuals who have suspicious peripheral pulmonary lesion(s) when flexible bronchoscopy alone or with endobronchial ultrasound are inadequate to sample the pulmonary lesion(s), the evidence includes meta-analyses, 2 randomized controlled trials (RCTs), and uncontrolled prospective observational studies. Relevant outcomes are test accuracy and validity, other test performance measures, and treatment-related morbidity. A 2023 meta-analysis of 55 studies, a 2020 meta-analysis of 40 studies, and a 2015 meta-analysis of 17 studies of electromagnetic navigation bronchoscopy (ENB) reported a large pooled positive likelihood ratio but a small negative likelihood ratio. Similarly, a 2014 meta-analysis of 15 studies found that navigation success was high, but diagnostic yield (64.9; 95% confidence interval [CI], 59.2 to 70.3) and negative predictive value (52.1; 95% CI, 43.5 to 60.6) were relatively low. In a 2024 meta-analysis of 363 studies (of which 94 assessed ENB), the diagnositc yield for ENB was 72.7%, which did not significantly differ when compared to other bronchoscopic procedures. The systematic reviews assessed the methodological quality of the evidence as low. In a 2025 multicenter RCT of 234 patients with intermediate-to-high-risk pulmonary nodules, ENB was noninferior to transthoracic needle biopsy in diagnostic accuracy (79% vs. 74%) and had markedly fewer complications (5.0% vs. 29.2%). Results from 2 large prospective multicenter uncontrolled studies, AQuiRE (American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education) and NAVIGATE (Clinical Evaluation of superDimension Navigation System for Electromagnetic Navigation Bronchoscopy), provide information about test characteristics and safety of ENB. An analysis of more than 500 patients included in the AQuiRE registry found a diagnostic yield of ENB that was lower than in other studies, and lower than bronchoscopy without ENB or endobronchial ultrasound. In the US cohort of the NAVIGATE study, the 2- year diagnostic yield was 69.8%. Overall, 4.3% of patients experienced pneumothorax, and grade 2 or higher pneumothorax occurred in 2.9% of patients. Bronchopulmonary hemorrhage occurred in 2.5% of patients overall, and grade 2 or higher bronchopulmonary hemorrhage in 1.6% of patients. There were no deaths related to the ENB device. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have enlarged mediastinal lymph nodes who receive ENB with flexible bronchoscopy, the evidence includes a RCT and case series.. Relevant outcomes are test accuracy and validity, other test performance measures, and treatment-related morbidity. There is less published literature on ENB for diagnosing mediastinal lymph nodes than for diagnosing pulmonary lesions. One RCT identified found higher sampling and diagnostic success with ENB-guided transbronchial needle aspiration than with conventional transbronchial needle aspiration. Endobronchial ultrasound, which has been shown to be superior to conventional transbronchial needle aspiration, was not used as the comparator. The RCT did not report the diagnostic accuracy of ENB for identifying malignancy, and this was also not reported in uncontrolled studies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have lung tumor(s) who need fiducial marker placement prior to treatment when flexible bronchoscopy alone or with endobronchial ultrasound are inadequate to place the markers near the pulmonary lesion(s), the evidence includes 1 comparative observational study and several noncomparative observational studies and case series. Relevant outcomes are health status measures and treatment-related morbidity. In the largest series, a subgroup analysis of 258 patients from the NAVIGATE study, the subjective assessment of outcome was that 99.2% of markers were accurately placed and 94.1% were retained at follow-up (mean 8.1 days postprocedure). Pneumothorax of any grade occurred in 5.4% of patients, and grade 2 or higher pneumothorax occurred in 3.1%. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History

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Date Action 9/2025 Annual policy review. Description, summary and references updated. Policy statements unchanged. 8/2024 Annual policy review. References updated. Policy statements unchanged.
8/2023 Annual policy review. Description, summary and references updated. Policy statements unchanged. 8/2022 Annual policy review. Description, summary and references updated. Policy statements unchanged. 9/2020 Annual policy review. Medically necessary policy statement edited for clarity to separate out indications; statements otherwise unchanged. 12/2019 Annual policy review. Populations for indications 1 (peripheral pulmonary lesions) and 3 (fiducial marker placement) revised to specify subgroups of patients for whom flexible bronchoscopy alone or with endobronchial ultrasound are inadequate. Policy statements changed to medically necessary. Clarified coding information. Effective 12/1/2019. 11/2018 Annual policy review. Description, summary and references updated. Policy statements unchanged.
7/2017 Annual policy review. New references added. 7/2016 Annual policy review. New references added. 11/2015 Added coding language. 3/2015 Annual policy review. New references added. 4/2014 Annual policy review. New references added. 2/2013 Annual policy review. New references added. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
4/2011 Reviewed - Medical Policy Group – Cardiology and Pulmonology. No changes to policy statements. 8/1/2010 Medical Policy #203 effective 8/1/2010 created.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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6. Balasubramanian P, Abia-Trujillo D, Barrios-Ruiz A, et al. Diagnostic yield and safety of diagnostic techniques for pulmonary lesions: systematic review, meta-analysis and network meta-analysis. Eur Respir Rev. Jul 2024; 33(173). PMID 39293856

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7. Sun X, Su Y, Li S, et al. [Diagnostic Value and Safety of Electromagnetic Navigation Bronchoscopy 
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26. Rong Y, Bazan JG, Sekhon A, et al. Minimal Inter-Fractional Fiducial Migration during Image-Guided Lung Stereotactic Body Radiotherapy Using SuperLock Nitinol Coil Fiducial Markers. PLoS One. 2015; 10(7): e0131945. PMID 26158847
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