Electromagnetic Navigation Bronchoscopy

Description of Procedure or Service

Electromagnetic navigation bronchoscopy (ENB) is intended to enhance standard bronchoscopy by providing a three-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 undergo biopsy and to allow for placement of fiducial markers.

Pulmonary nodules are identified on plain chest radiographs or chest computed tomography (CT) scans. Although most of these nodules are benign, some are cancerous, and early diagnosis of lung cancer is desirable because of the poor prognosis when cancer is diagnosed later in the disease course. The method used to diagnosis lung cancer depends on a number of factors, including lesion size and location, as well as the clinical history and status of the patient. There is generally greater diagnostic success with centrally located and larger lesions.

Peripheral lung lesions and solitary pulmonary nodules (SPN) (most often defined as asymptomatic nodules less than 30 mm) 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% 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%–25% of patients, and 5%–14% require insertion of a chest tube. Positron emission tomography (PET) scans are also highly sensitive for evaluating pulmonary nodules, yet may miss small lesions less than 1 cm in size. Surgical lung biopsy is the gold 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 the size and location of the lesion.

Another proposed enhancement to standard bronchoscopy is electromagnetic navigation bronchoscopy (ENB) using the InReach™ system. This technology uses CT scans to improve the ability of standard bronchoscopic procedures to reach lesions in the periphery of the lungs. The three phases of the procedure using the InReach system are as follows:

1. Planning phase: The previously taken CT scans are loaded onto a computer, and proprietary software is used 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 for use during the procedure;
2. Registration phase: A steerable navigation 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 1, and these virtual images are correlated with the actual image from the video bronchoscope.
3. Navigation phase: The steerable navigation catheter is moved toward the target, and the realtime location of the catheter’s tip is displayed on the CT images. When the navigation catheter reaches the target, it is locked in place. Once this occurs, endoscopic tools can be inserted through the channel in the catheter to the target. This includes insertion of a 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.

Regulatory Status

In 2004, the superDimension/Bronchus (superDimension Ltd, Herzliya, Israel) InReach system 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 it is not approved for pediatric use. As of June 2016, the current version of the product is the Medtronic SuperDimension Navigation System (Medtronic, Minneapolics, MN).

In 2009, the ig4 EndoBronchial system (Veran Medical; St. Louis, MO) 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".

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

• In 2008: The LungPoint virtual bronchoscopic navigation (VPN) system (Broncus Technologies, Mountain View, CA).
• In 2010: The bf-NAVI virtual bronchoscopic navigation (VPN) system (Emergo Group, Austin, TX).

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

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

BCBSNC will provide coverage for Electromagnetic Navigation Bronchoscopy when it is determined to be medically necessary because the medical criteria and guidelines noted below are met.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Electromagnetic Navigation Bronchoscopy is covered

Electromagnetic Navigation Bronchoscopy is considered medically necessary for one of the following indications:

• Patients with a suspicious pulmonary nodule that is deemed inaccessible by standard methods (e.g. peripheral nodule) or when standard methods have failed; OR
• Patients with a highly suspicious solitary pulmonary nodule who pose an unacceptable risk (e.g., bullous lung disease, diffuse emphysema) for a more invasive diagnostic procedure; OR
• Patients with an identified lung lesion(s) and a diagnosis of co-existing cancer in whom further determination of the lung lesion will impact staging of the primary tumor and thus impact the treatment plan; OR
• Placement of fiducial markers in patients who are not candidates for surgical intervention and who have elected to undergo radiation therapy.

When Electromagnetic Navigation Bronchoscopy is not covered

Use of electromagnetic navigation bronchoscopy for any other indication is considered investigational.

Policy Guidelines

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, a randomized controlled trial, and uncontrolled observational studies. A 2020 meta-analysis of 40 studies and a 2015 meta-analysis of 17 studies of 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 and negative predictive value were relatively low. Both systematic reviews assessed the methodological quality of the evidence as low. Results from two large prospective multicenter uncontrolled studies, AQuiRE and NAVIGATE, 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 (EBUS). 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. Overall, bronchopulmonary hemorrhage occurred in 2.5% of patients, 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 one comparative observational study and several noncomparative observational studies and case series. The 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. Pneumothorax of any grade occurred in 5.4% of patients, and grade 2 or higher pneumothorax occurred in 3.1%. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. Evidence reported through clinical input supports that this use provides a clinically meaningful improvement in net health outcome and is consistent with generally accepted medical practice. The key advantage of ENB placement is the markedly reduced risk of pneumothorax compared to the transthoracic approach. Patients being treated with targeted radiation are typically those with advanced respiratory disease who cannot undergo surgical resection. They are also more at risk for pneumothorax and resultant further complications. As the markers need to be near and not necessarily in a lesion, the accuracy advantage of a transthoracic approach is outweighed by the safety advantage of ENB over a transthoracic approach. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

While the evidence base consists largely of case series, there is some evidence that ENB provides a minimally invasive option for a select subset of patients where a tissue diagnosis is not feasible by conventional bronchoscopy methods. Diagnostic rates appear comparable to transthoracic needle biopsy for these patients.

Current National Comprehensive Cancer Network ( v.3.2023) practice guidelines on non-small-cell lung cancer state that the strategy for diagnosing lung cancer should be individualized and the least invasive biopsy with the highest diagnostic yield is preferred as the initial diagnostic study.27,

• "Patients with central masses and suspected endobronchial involvement should undergo bronchoscopy.
• Patients with peripheral (outer one-third) nodules may benefit from navigational bronchoscopy, radial EBUS [endobronchial ultrasound], or transthoracic needle aspiration...
• Patients with suspected nodal disease should be biopsied by EBUS, EUS [endoscopic ultrasound], navigation biopsy, or mediastinoscopy."

In 2013, the American College of Chest Physicians issued updated guidelines on the diagnosis of lung cancer. Regarding ENB, the guideline stated: “In patients with peripheral lung lesions difficult to reach with conventional bronchoscopy, electromagnetic navigation guidance is recommended if the equipment and the expertise are available.” The authors noted that the procedure can be performed with or without fluoroscopic guidance and has been found to complement radial probe ultrasound. The strength of evidence for this recommendation as grade 1C, defined as “Strong recommendation, low- or very-low-quality evidence.”

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable codes: 31627, C7509, C7510, C7511

Code 31627 is an add-on code that is used in conjunction with CPT codes 31615, 31622-31631, 31635, 31636, and 31638-31643. Code 31627 includes 3-dimensional reconstruction so it should not be reported with codes 76376 and 76377.

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. 

Scientific Background and Reference Sources

Rivera MP, Mehta AC. Initial diagnosis of lung cancer. Chest 2007; 132(3 suppl):131S-148S.

Tape TG. Solitary pulmonary nodule. In Black ER, Bordley DR, Tape TG et al., eds. Diagnostic Strategies for Common Medical Problems, second ed. Philadelphia, PA: American College of Physicians, 1999.

Alberts WM. Diagnosis and management of lung cancer: executive summary: ACCP evidence-based clinical practice guidelines (2nd edition). Chest 2007; 132(3 suppl):1S-19S.

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 11/12/09

Senior Medical Director Review 1/21/2010.

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 2/2010

Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest 2011; Epub ahead of print.

Du Rand IA, Barber PV, Goldring J et al. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66(Suppl 3):iii1-21.

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 1/12/12

Specialty Matched Consultant Advisory Panel review 3-2012

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 1/10/13

Specialty Matched Consultant Advisory Panel review 3-2013

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 1/9/14

Specialty Matched Consultant Advisory Panel review 4/2014

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 1/15/15

Specialty Matched Consultant Advisory Panel review 3/2015

Specialty Matched Consultant Advisory Panel review 3/2016

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 6/16/16

Specialty Matched Consultant Advisory Panel review 3/2017

Rivera MP, et al. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidenced-based clinical practice guidelines. Chest 2013 May;143(5 Suppl):e142S-165S.

National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer Version IV 2016. [http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf] accessed 12/28/16.

https://www.ncbi.nlm.nih.gov/pubmed/28206930

Am Surg. 2016 Nov 1;82(11):1052-1054.- case series of adding dye to remove nodules.

Ann Am Thorac Soc. 2016 Dec;13(12):2223-2228. highlights that CT may decrease unnecessary

procedures. Highlights ubiquity of the procedure and good yield.

Ann Am Thorac Soc. 2016 Dec;13(12):2223-2228. YIELD >96.8% and PTX rate 6.8%

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 6/8/17

Senior Medical Director review 9/2017

Specialty Matched Consultant Advisory Panel review 3/2018

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 6/14/18

Specialty Matched Consultant Advisory Panel review 3/2019

https://isrg.intuitive.com/news-releases/news-release-details/u-s-fda-grants-clearance-ion-intuitive

https://www.itnonline.com/content/auris-health-unveils-fda-cleared-monarch-platform-roboticbronchoscopy

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 12/31/19

Specialty Matched Consultant Advisory Panel review 3/2020

Medical Director review 12/2020

BCBSA Medical Policy Reference Manual [Electronic Version]. 7.01.122, 7/16/20

Specialty Matched Consultant Advisory Panel review 3/2021

Medical Director review

Specialty Matched Consultant Advisory Panel review 3/2022

Medical Director review 3/2022

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 3.2022. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.

Specialty Matched Consultant Advisory Panel review 3/2023

Medical Director review 3/2023

Detterbeck FC, Mazzone PJ, Naidich DP, et al. Screening for lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. May 2013; 143(5 Suppl): e78S-e92S. PMID 23649455

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 3.2023. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.

Specialty Matched Consultant Advisory Panel review 3/2024

Medical Director review 3/2024

Policy Implementation/Update Information

2/16/10 New policy issued. Electromagnetic navigation bronchoscopy is considered investigational for use with flexible bronchoscopy for the diagnosis of pulmonary lesions and mediastinal lymph nodes. (adn)

2/1/11 Added statement under “Not Covered Section” to indicate: “Electromagnetic navigation bronchoscopy is considered investigational for the placement of fiducial markers. Added new CPT code 31626 under “Billing/Coding Section”. Removed policy number. References added. (lpr)

4/12/11 Information in the Description and Policy Guidelines sections updated. Specialty Matched Consultant Advisory Panel review 3/30/11. No change to policy statement or medical coverage criteria. (adn)

3/30/12 Specialty Matched Consultant Advisory Panel review 3/21/2012. Updated references and policy guidelines. No change to policy statement.(lpr)

4/16/13 Revised Policy Guidelines section. Specialty Matched Consultant Advisory panel review 3/20/2013. Reference added. No change to policy statement. (lpr)

5/13/14 Specialty Matched consultant advisory panel review meeting 4/30/14. No change to policy statement. Reference updated. Deleted CPT code 31626 from Billing/Coding section. Medical director review 4/2014. (lpr)

2/24/15 Reference added. (lpr)

4/28/15 Specialty Matched Consultant Advisory panel review 3/25/2015. No change to policy statement. (lpr)

4/29/16 Specialty Matched Consultant Advisory Panel review 3/30/2016. Updated Policy Guidelines section. No change to policy statement. (lpr)

7/26/16 Updated Policy Guidelines and Regulatory status sections. Reference added. No change to policy statement. (lpr)

9/15/17 Specialty Matched Consultant Advisory Panel review 3/29/2017. Coverage statement revised with medical necessity criteria. Updated Policy Guidelines section. References added. Senior Medical Director review 9/2017. (lpr)

4/13/18 Specialty Matched Consultant Advisory Panel review 3/28/2018. No change to policy statement. (lpr)

7/27/18 Reference added. (lpr)

4/30/19 Specialty Matched Consultant Advisory Panel review 3/20/2019. Updated Regulatory Status. References added. No change to policy statement. (lpr)

4/28/20 Specialty Matched Consultant Advisory Panel review 3/31/2020. Policy guidelines updated. No change to policy statement. (eel)

12/31/20 Within “When Covered” section, clarified standard methods with “(e.g. peripheral nodule)”. Added “diagnosis” to “When Covered” sections 3rd bullet point. Medical Director review. (bb)

5/18/21 Specialty Matched Consultant Advisory Panel review 3/2021. Regulatory Status and Policy guidelines updated. Reference added. Medical Director review 4/2021. No change to policy statement. (bb)

3/31/22 Specialty Matched Consultant Advisory Panel review 3/2022. Policy guidelines updated. References added. Medical Director review 3/2022. No change to policy statement (tt)

12/30/22 Updated Billing/Coding section to add C7509, C7510, and C7511, effective 1/1/2023. (tt)

3/31/23 Specialty Matched Consultant Advisory Panel review 3/2023. Policy guidelines and Regulatory status updated. References added. Medical Director review 3/2023. No change to policy statement (tt)

4/1/24 Specialty Matched Consultant Advisory Panel review 3/2024. Policy Guidelines and References updated. Medical Director review 3/2024. No change to policy statement. (tt)