Latest Review Date: October 2024

Category:  Surgical                                                                

POLICY:

Endobronchial ultrasound guidance with transbronchial needle biopsy may be considered medically necessary for the evaluation of peripheral pulmonary lesions in individuals with suspected lung cancer when BOTH of the following criteria are met:

• Tissue biopsy of the peripheral pulmonary lesion is required for diagnosis; AND
• The peripheral pulmonary lesion is not accessible using standard bronchoscopic techniques

Endobronchial ultrasound guidance with transbronchial needle biopsy may be considered medically necessary for mediastinal staging in individuals with diagnosed lung cancer when ALL of the following criteria are met:

• The individual is suitable and willing to undergo specific treatment for lung cancer, with either curative or palliative intent; AND
• Tissue biopsy of abnormal mediastinal lymph nodes seen on imaging is required for staging and specific treatment planning; AND
• Abnormal lymph nodes seen on imaging are accessible by EBUS-TBNA biopsy

Endobronchial ultrasound is considered investigational for diagnosis and staging of lung cancer when the above criteria are not met.

Endobronchial ultrasound for all other indications is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Endobronchial ultrasound (EBUS) is an imaging technique for adjunctive use with standard flexible bronchoscopy. It provides an ultrasound-generated image of the lungs beyond the airway walls, extending to peribronchial structures and distal peripheral lung lesions. The purpose of EBUS is to facilitate navigation to distal regions of the lungs and biopsy of peripheral pulmonary nodules; especially suspected cancerous lesions. Another intended use of EBUS is to localize and facilitate biopsy of the mediastinal lymph nodes as part of staging for non-small-cell lung cancer. Both techniques primarily use transbronchial needle aspiration (TBNA) of lesions to obtain tissue samples.

Lung Cancer

Individuals who are suspected of having lung cancer may present with widely differing signs and symptoms that are related to the type of cancer (e.g., NSCLC vs small-cell lung cancer [SCLS]), its location within the lung, and the stage of disease (i.e., localized, locoregionally advanced, metastatic). All three of the major parameters of type, location, and the stage will dictate subsequent management of cancer, determining whether it is primarily surgical or requires systemic chemotherapy. Early diagnosis of lung cancer is essential because of the uniformly poor prognosis when cancer is diagnosed later in the disease course.

Approximately 75% to 80% of newly diagnosed lung cancers are NSCLC. The clinical presentation and findings on computed tomography (CT) or a fluorine 18 fluorodeoxyglucose (FDG) positron emission tomography (PET) scan of the chest will typically permit a presumptive diagnosis of lung cancer and differentiation between NSCLC and SCLC. If SCLC is suspected based on radiographic characteristics and other clinical findings, a diagnosis is made by whatever means is the least invasive (e.g., sputum cytology, thoracentesis if an accessible pleural effusion is present, fine-needle aspiration of a supraclavicular node).  The diagnostic technique to evaluate suspected NSCLC is usually dictated by the apparent stage of the disease. NSCLC can present with extensive infiltration of the mediastinum, defined as a mass with no visible lymph nodes, or it may present as a solitary pulmonary nodule that may be bronchogenic or peripheral. In any patient with suspected NSCLC, the diagnosis should be established by the method that has the most favorable risk-benefit ratio.

Diagnosis of Peripheral Pulmonary Nodules

Solitary pulmonary lesions are typically identified on plain chest radiographs or chest CT scans, often incidentally. Although most of these nodules will be benign, some will be cancerous. Peripheral lung lesions and solitary pulmonary nodules (most often defined as asymptomatic nodules <8 mm) are more difficult to evaluate than larger, centrally located lesions. There are several options for diagnosis, however none of the methods are ideal for safely and accurately diagnosing malignant disease in all patients. Sputum cytology is the least invasive approach. Reported sensitivity rates are relatively low and vary widely across studies, and sensitivity is even 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 the most common 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% due to the inability to reach into smaller bronchioles.

Transthoracic (percutaneous) needle aspiration (TNA), using CT guidance, can be performed for peripheral nodules that are beyond the reach of traditional bronchoscopy. The diagnostic accuracy of TNA tends to be as high or higher than that of flexible bronchoscopy for peripheral lesions; the sensitivity and specificity are both greater than 90%. A disadvantage of TNA is that a pneumothorax may occur in as many as 15% of patients, although this number can range from 1% to 15%. About 1% to 7% will 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. Surgical lung biopsy is the criterion standard for diagnosing pulmonary nodules but is an invasive procedure that is not indicated for all patients.

Staging of Lung Cancer: Assessment of Mediastinal Involvement

The stage of lung cancer-its extent through the body-at diagnosis will directly impact the management approach for each patient. The first step in staging is to identify whether the patient has distant metastatic disease (M stage) or the tumor is confined to the chest; this will determine if treatment should be aimed at palliation or at potential cure, respectively. If the primary tumor is confined (T stage), determining whether the mediastinal lymph nodes (N stage) are involved is a crucial factor in guiding therapy.

As for diagnostic procedures, there are a number of options for mediastinal staging. The choice of a noninvasive or invasive staging method is dictated by the patient’s condition, whether or not he or she can tolerate or will elect surgery. Thus, staging procedures may be based on noninvasive imaging (i.e., CT or PET, or combined PET-CT) methods, or be fully invasive such as a mediastinoscopy, a surgical procedure that is performed under general anesthesia and is regarded as the reference standard for staging lung cancer.

Recent advances in technology have led to enhancements that may increase the yield of established needle-based diagnostic methods that represent a third approach between noninvasive and surgical procedures. CT scanning equipment can be used to guide flexible bronchoscopy and bronchoscopic transbronchial needle biopsy but has the disadvantage of exposing the patient and staff to radiation.

Endobronchial Ultrasound with Transthoracic Needle Aspiration

Among its potential applications, endobronchial ultrasound (EBUS) using ultrasound probes, can be used to locate and guide sampling of pulmonary lesions and mediastinal lymphadenopathy.

EBUS uses two distinct types of transducers that have specific uses: radial probe and convex probe.

A radial probe EBUS comprises a 20- or 30-MHz rotating transducer to provide high-resolution 360° radial images. The probe is inserted into the airways via a standard therapeutic bronchoscope. With the use of an ultrathin bronchoscope combined with radial probe EBUS through a guide sheath, an endoscopist can reach and visualize the sixth- to eighth-generation bronchi, whereas a traditional bronchoscope can only reach the fourth-generation bronchi. The use of radial probe EBUS imaging allows the physician to verify visually that a lesion has been reached and to maintain a position in the periphery to allow a needle biopsy to be performed for diagnosis. These probes do not allow real-time imaging during biopsy. For biopsy or tissue sampling, the target area is located by radial probe EBUS; the radial probe is subsequently retracted and is replaced with a biopsy or sampling device.

Convex probe EBUS transducers are adjustable within a frequency range of 5 to 12 MHz. Such transducers are incorporated into the structure of a dedicated bronchoscope and provide real-time pie-slice sector views of 50° to 60° parallel to the axis of the bronchoscope. Convex probe EBUS with transbronchial needle aspiration (EBUS-TBNA) also can be used for staging the mediastinal nodes. The curved linear probe technology allows real-time visualization and needle aspiration of a lesion. Because EBUS-TBNA of the mediastinal nodes may be performed under conscious sedation, it may be used in patients who are not surgical candidates but for whom accurate staging is needed to guide choice among systemic treatments, particularly targeted systemic agents such as tyrosine kinase inhibitors.

KEY POINTS:

The most recent literature review was updated through July 10, 2024.

Summary of Evidence

For individuals who have peripheral pulmonary lesions and suspected lung cancer who receive endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for diagnosis, the evidence includes recent systematic reviews, meta-analyses, and two small randomized trials. The relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, and morbid events. Evidence supports a conclusion that EBUS-TBNA has diagnostic performance characteristics for solitary pulmonary lesions similar to those of traditional flexible bronchoscopy with transthoracic needle aspiration. The evidence also indicates that the safety profile of EBUS-TBNA may be better than the profile of other techniques, as reflected by pneumothorax and chest tube insertion rates. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lung cancer and mediastinal lymph nodes that are seen on imaging who receive EBUS-TBNA for staging, the evidence includes systematic reviews and meta-analyses. The relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, and morbid events. Evidence from systematic reviews of observational studies supports a conclusion that EBUS-TBNA exhibits test performance characteristics similar to other needle-based methods used to stage the mediastinum in patients diagnosed with lung cancer. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Chest Physicians

The American College of Chest Physicians (ACCP) has offered a number of evidence-based guidelines on the use of endobronchial ultrasound (EBUS) guided needle aspiration of pulmonary lesions for diagnosis of lung cancer1 and mediastinal staging of patients diagnosed with lung cancer (Table 1).  A separate guideline and expert panel report (2016) has addressed the technical aspects of EBUS-guided transbronchial needle aspiration and its use outside the setting of lung cancer.

Table 1. Guidelines on Use of Endobronchial Ultrasound to Diagnose and Stage Lung Cancer

EBUS: endobronchial ultrasound; PET: positron emission tomography; TBNA: transbronchial needle aspiration.

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on non-small-cell lung cancer (v.7.2024) state:

“The least invasive biopsy with the highest yield is preferred as the first diagnostic study…. Patients with pulmonary nodules may benefit from navigational bronchoscopy (including robotic), radial EBUS [endobronchial ultrasound], or transthoracic needle aspiration (TTNA)…. Patients with suspected nodal disease should be biopsied by EBUS, EUS [endoscopic ultrasound], navigational bronchoscopy or mediastinoscopy.”

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force recommendations for endobronchial ultrasound have been identified.

KEY WORDS:

Endobronchial Ultrasound, EBUS, Transbronchial needle biopsy, TBNA, lung cancer, Olympus Medical Systems EU-M60 EUS Exera, EVIS EXERA Bronchofibervideoscope, ATL HDI 5000 Ultrasound System, Olympus BF type UC160F-OL8 bronchoscope, ALOKA SSD-Alpha 5/10 Ultrasound System, Olympus Medical Systems XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope, PENTAX Ultrasound Video bronchoscope EB-1970UK + HI VISION Preirus endoscopic ultrasound, Medi-Globe SonoTip® II EBUS-TBNA Needle System, Cook EchoTip®, Medi-Globe SonoTip® Pro and Pro Flex EBUS-TBNA, EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, EndoCORE®

APPROVED BY GOVERNING BODIES:

A number of instruments are commercially available to perform EBUS-TBNA for diagnosis and staging of lung cancer. All have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process and are shown in Table 2.

Table 2. FDA-Cleared Instruments Used to Perform EBUS-TBNA

EBUS: endobronchial ultrasound; EUS: endoscopic ultrasound; FDA: Food and Drug Administration; FNA: fine-needle aspiration; TBNA: transbronchial needle aspiration; US: ultrasound.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

PREVIOUS CODING:

REFERENCES:

1. Ali MS, Trick W, Mba BI, et al. Radial endobronchial ultrasound for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Respirology. Apr 2017; 22(3):443-453.
2. Chandra S, Nehra M, Agarwal D, et al. Diagnostic accuracy of endobronchial ultrasound-guided transbronchial needle biopsy in mediastinal lymphadenopathy: a systematic review and meta-analysis. Respir Care. Mar 2012; 57 (3):384-391.
3. Colt HG, Davoudi M, Murgu S. Scientific evidence and principles for the use of endobronchial ultrasound and transbronchial needle aspiration. Expert Rev Med Devices. Jul 2011; 8(4):493-513.
4. Dhoori S, Aggarwal AN, Gupta D, et al. Utility and safety of endoscopic ultrasound with bronchoscope-guided fine-needle aspiration in mediastinal lyph node sampling: systematic review and meta-analysis. Respir Care. Jul 2015; 60(7):1040-1050.
5. Dong X, Qiu X, Liu Q, et al. Endobronchial ultrasound-guided transbronchial needle aspiration in the mediastinal staging of non-small cell lung cancer: a meta-analysis. Ann Thorac Surg. Oct 2013; 96 (4):1502-1507.
6. El-Osta H, Jani P, Mansour A, et al. Endobronchial ultrasound for nodal staging of patients with non-small-cell lung cancer with radiologically normal mediastinum. A Meta-Analysis. Ann Am Thorac Soc. Jul 2018; 15(7):864-874.
7. Fielding DI, Chia C, Nguyen P, et al. Prospective randomised trial of endobronchial ultrasound-guide sheath versus computed tomography-guided percutaneous core biopsies for peripheral lung lesions. Intern Med J. Aug 2012; 42 (8):894-900.
8. Ge X, Guan W, Han F, et al. Comparison of endobronchial ultrasound-guided fine needle aspiration and video-assisted mediastinoscopy for mediastinal staging of lung cancer. Lung. Oct 2015; 193(5):757-766.
9. Gould MK, Donington J, Lynch WR, et al. Evaluation of individuals with pulmonary nodules: when is it 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):e93S-120S.
10. Han Y, Kim HJ, Kong KA, et al. Diagnosis of small pulmonary lesions by transbronchial lung biopsy with radial endobronchial ultrasound and virtual bronchoscopic navigation versus CT-guided transthoracic needle biopsy: A systematic review and meta-analysis. PLoS One. Jan 2018; 13(1):e0191590.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 7.2024. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
13. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of 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):e142S-165S.
14. Roth K, Eagan TM, Andreassen AH, et al. A randomised trial of endobronchial ultrasound guided sampling in peripheral lung lesions. Lung Cancer. Nov 2011; 74(2):219-225.
15. Silvestri GA, Gonzalez AV, Jantz MA, et al. Methods for staging non-small cell 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):e211S-250S.
16. Steinfort DP, Khor YH, Manser RL, et al. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. Apr 2011; 37(4):902-910.
17. Wahidi MM, Herth F, Yasufuku K, et al. Technical aspects of endobronchial ultrasound guided transbronchial needle aspiration: CHEST Guideline and Expert Panel Report. Chest. Mar 2016; 149(3):816-835.
18. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. Aug 2012; 142(2):385-393.
19. Wiener RS, Schwartz LM, Woloshin S, et al. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. Aug 2 2011; 155 (3):137-144.
20. Ye J, Zhang R, Ma S, et al. Endobronchial ultrasound plus fluoroscopy-guided biopsy compared to fluoroscopy-guided transbronchial biopsy for obtaining samples of peripheral pulmonary lesions: A systematic review and meta-analysis. Ann Thorac Med. Apr-Jun 2017; 12(2):114-120.

POLICY HISTORY:

Medical Policy Panel, November 2014

Medical Policy Group, January 2014(3): Adopted new policy from Association

Medical Policy Administration Committee

Available for comment January 9 through February 22, 2015

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added CPT codes 31652, 31653, and 31654 to current coding. Created a previous coding section and moved CPT code 31620 from current coding to the newly created previous coding section.

Medical Policy Panel, January 2016

Medical Policy Group, February 2016: 2016 Updates to Description, Key Points, Current Coding, and References; no change to policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): Updates to Description, Key Points, Practice Guidelines, and References. No change in Policy Statement.

Medical Policy Panel, September 2018

Medical Policy Group, October 2018 (3): Updates to Key Points, Practice Guidelines, and References. No change in policy statement or intent.

Medical Policy Panel, September 2019

Medical Policy Group, September 2019 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, September 2020

Medical Polivy Group, September 2020 (5): Updates to Description, Key Points, and Practice Guidelines and Position Statements. No change to Policy Statement.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, References. No change to Policy Statement.

Medical Policy Panel, September 2022

Medical Policy Group, September 2022 (5): Updates to Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.

Medical Policy Panel, September 2023

Medical Policy Group, September 2023 (5): Updates to Key Points, Practice Guidelines, Benefit Application, and References. Policy Statement: Endobronchial ultrasound for all other indications is considered investigational- Updated to remove the words “not medically necessary” and leave the word “investigational. No change to policy intent.

Medical Policy Panel, September 2024

Medical Policy Group, October 2024 (5): Updates to Key Points; Practice Guidelines and Position Statements, Key Words: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, EndoCORE®, and Approved by Governing Bodies. Policy Statement updated to replace the words “not medically necessary” with “investigational.” No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.