CurrentBlue Shield of CaliforniaPolicy 6.01.58

Endobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

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This policy governs coverage of EBUS-TBNA for diagnosing suspected lung cancer in peripheral pulmonary lesions and for mediastinal staging in diagnosed lung cancer. Coverage is limited to specified clinical circumstances; other indications or cases not meeting the criteria are considered investigational.

Policy Summary

PayerBlue Shield of California

PolicyEndobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

Policy CodePolicy 6.01.58

Change TypeAnnual literature reviewno material clinical or coverage change

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionSubmit clinical review documentation, including history and physical or consultation notes, the treatment plan, and prior imaging results.

SourceLink

POLICY UPDATE CHANGES

The 2025 annual review updated the literature review without changing the policy statement.

2Covered clinical use cases

2Peripheral lesion criteria

3Mediastinal staging criteria

Investigational

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CurrentBlue Shield of CaliforniaPolicy 6.01.58

Endobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

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Sign up for blue_shield_of_california Policy 6.01.58 alerts

Get alerted when Policy 6.01.58 changes without checking for updates manually.

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Policy Summary

PayerBlue Shield of California

PolicyEndobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

Policy CodePolicy 6.01.58

Change TypeAnnual literature reviewno material clinical or coverage change

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionSubmit clinical review documentation, including history and physical or consultation notes, the treatment plan, and prior imaging results.

SourceLink

POLICY UPDATE CHANGES

The 2025 annual review updated the literature review without changing the policy statement.

2Covered clinical use cases

2Peripheral lesion criteria

3Mediastinal staging criteria

Investigational

Medical Necessity Criteria

Diagnosis of Peripheral Pulmonary Lesions

EBUS-TBNA may be considered medically necessary for evaluation of a peripheral pulmonary lesion in an individual with suspected lung cancer when ALL of the following criteria are met:

ALL of the following

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

Mediastinal Staging

EBUS-TBNA may be considered medically necessary for mediastinal staging in an individual with diagnosed lung cancer when ALL of the following criteria are met:

ALL of the following

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

Diagnosis of Lung Cancer

ACCP guideline-supported diagnostic uses of EBUS and related needle techniques include the following:

At least ONE applicable diagnostic pathway

ALL of the following
- The individual is suspected of having lung cancer.
- Radiographic studies show extensive infiltration of the mediastinum.
- There is no evidence of extrathoracic metastatic disease, including a negative PET scan.
- Lung cancer diagnosis is established by the least invasive and safest method, such as bronchoscopy with TBNA, EBUS-NA, EUS-NA, TTNA, or mediastinoscopy.
  ACCP recommendation 2.3.2; Grade 1C.
ALL of the following

Mediastinal Staging

For mediastinal staging, ACCP recommends needle-based techniques as the best first test when ALL of the following circumstances apply:

ALL of the following

The individual has diagnosed lung cancer.
There is high suspicion of N2 or N3 involvement based on discrete mediastinal lymph node enlargement or PET uptake.
There are no distant metastases.
A needle technique, including EBUS-NA, EUS-NA, or combined EBUS/EUS-NA, is used before surgical staging.
ACCP recommendation 4.4.4.3; Grade 1B. If clinical suspicion of mediastinal node involvement remains high after a negative needle-technique result, surgical staging such as mediastinoscopy or VATS should be performed.

NCCN Diagnostic and Staging Guidance

NCCN guidance supports use of the least invasive biopsy with the highest yield as the first diagnostic study. The following diagnostic and staging approaches are guideline-supported when clinically appropriate:

ONE of the following guideline-supported approaches

For pulmonary nodules, use navigational bronchoscopy, including robotic bronchoscopy, radial EBUS, or transthoracic needle aspiration (TTNA).
For suspected nodal disease, obtain biopsy by EBUS, EUS, navigational bronchoscopy, or mediastinoscopy.

Peripheral Pulmonary Lesion Diagnosis — Medical-Necessity Pathway

The medical-necessity pathway for peripheral pulmonary lesion diagnosis requires both policy criteria below:

ALL of the following

The individual has suspected lung cancer and tissue biopsy of the peripheral pulmonary lesion is required for diagnosis.
The peripheral pulmonary lesion is not accessible using standard bronchoscopic techniques.

Mediastinal Staging — Medical-Necessity Pathway

The medical-necessity pathway for mediastinal staging requires ALL of the following:

ALL of the following

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

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

Endobronchial ultrasound is considered investigational for all other indications outside qualifying peripheral pulmonary lesion diagnosis and mediastinal staging.

Under the updated policy pathway, EBUS-TBNA is considered investigational for diagnosis or staging of lung cancer when the applicable medical-necessity criteria are not satisfied, and for all other indications.

Failure to meet the required medical-necessity criteria— including the need for tissue diagnosis or staging, lesion or node accessibility, and treatment suitability where applicable—results in investigational status rather than coverage under the medical-necessity pathway.

Covered Clinical Uses

EBUS-TBNA for Diagnosis of Suspected Lung Cancer in a Peripheral Pulmonary Lesion

Covered when all of the following criteria are met.

Diagnosis of suspected lung cancer in a peripheral pulmonary lesion

The individual has suspected lung cancer and a peripheral pulmonary lesion.
Tissue biopsy of the peripheral pulmonary lesion is required for diagnosis.
The peripheral pulmonary lesion is not accessible using standard bronchoscopic techniques.

EBUS-TBNA for Mediastinal Staging in Diagnosed Lung Cancer

Covered when all of the following criteria are met.

Mediastinal staging in diagnosed lung cancer

Billing and Coding

EBUS-guided bronchoscopy sampling proceduresCPT

	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with endobronchial ultrasound (EBUS) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]), one or two mediastinal and/or hilar lymph node stations or structures
	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with endobronchial ultrasound (EBUS) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]), 3 or more mediastinal and/or hilar lymph node stations or structures

CPT codesCPT

31654

Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with transendoscopic endobronchial ultrasound (EBUS) during bronchoscopic diagnostic or therapeutic intervention(s) for peripheral lesion(s) (List separately in addition to code for primary procedure[s]).

Documentation and Review Requirements

Documentation Required

Document Clinical Necessity and Treatment Planning

Document the clinical necessity for EBUS-TBNA and how the results will direct diagnosis, staging, and specific treatment planning. The record should establish the patient’s clinical presentation, imaging findings, suitability and willingness for definitive lung-cancer treatment, and why EBUS-TBNA is the appropriate least-invasive diagnostic or staging approach.

Include a comprehensive history and physical examination and relevant consultation findings.
Document CT and whole-body PET or PET-CT results, including the presence or absence of extrathoracic metastatic disease.
For suspected lung cancer, document the clinical and radiographic basis for the presumptive diagnosis and the need to confirm it, preferably by the least-invasive method consistent with the patient’s presentation and treatment preferences.
Document treatment intent and planning, including whether the patient is suitable and willing to undergo curative or palliative treatment.
Explain why invasive biopsy or staging is needed rather than imaging surveillance or imaging-only assessment, when applicable.

Documentation Required

Clinical Background

EBUS is an adjunct to flexible bronchoscopy that uses ultrasound to visualize structures beyond the airway walls, including peribronchial structures and distal peripheral lung lesions. EBUS-guided transbronchial needle aspiration can obtain tissue from peripheral pulmonary lesions for diagnosis and from mediastinal lymph nodes for lung cancer staging.

Terms and Techniques

Definition

TermEndobronchial ultrasound (EBUS)

UseAn imaging technique used as an adjunct to standard flexible bronchoscopy.

FunctionProvides ultrasound-generated images beyond the airway walls, including peribronchial structures and distal peripheral lung lesions, to facilitate navigation and biopsy.

Definition

TermTransbronchial needle aspiration (TBNA)

TechniqueNeedle aspiration performed through the bronchoscope.

Purpose

Investigational and Noncovered Uses

EBUS is not covered when used for lung cancer diagnosis or staging without meeting the applicable medical-necessity criteria. It is also considered investigational for all other indications outside evaluation of qualifying peripheral pulmonary lesions in suspected lung cancer and mediastinal staging in diagnosed lung cancer.

Policy Summary

PayerBlue Shield of California

PolicyEndobronchial Ultrasound for Diagnosis and Staging of Lung Cancer

Policy CodePolicy 6.01.58

Change TypeAnnual literature reviewno material clinical or coverage change

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionSubmit clinical review documentation, including history and physical or consultation notes, the treatment plan, and prior imaging results.

SourceLink

On This Page

The individual is suspected of having lung cancer with a peripheral lung nodule.
A tissue diagnosis is required because of diagnostic uncertainty or poor surgical candidacy.
Radial EBUS is used as an adjunct imaging modality.
ACCP recommendation 3.3.2.1; Grade 1C.

The individual has diagnosed lung cancer and is suitable and willing to undergo specific treatment with curative or palliative intent.

Tissue biopsy of abnormal mediastinal lymph nodes seen on imaging is required for staging and specific treatment planning.

The abnormal lymph nodes seen on imaging are accessible by EBUS-TBNA.

Diagnosis of Suspected Lung Cancer in Patients with Pulmonary or Peripheral Pulmonary Lesions

Covered when all of the following criteria are met.

Diagnosis of suspected lung cancer

Pulmonary or peripheral pulmonary lesions are present and lung cancer is suspected.
EBUS-TBNA is used to isolate and biopsy the lesion for diagnosis, including when a prior less invasive test was inconclusive.
EBUS-TBNA is performed after peripheral pulmonary lesions are identified or when a prior less invasive test was inconclusive.

Mediastinal Staging of Lung Cancer

Covered when all of the following criteria are met.

Staging of detected lung cancer

Lung cancer has been detected or is being evaluated for staging.
Convex-probe EBUS with transbronchial needle aspiration is used to sample mediastinal lymph nodes and assess mediastinal involvement.

Staging Lung Cancer with Mediastinal Lymph Nodes Seen on Imaging

Covered when all of the following criteria are met.

Staging after lung cancer diagnosis

Lung cancer has been diagnosed or is being evaluated for staging.
Mediastinal lymph nodes are seen on imaging.
EBUS-TBNA is used after lung cancer is diagnosed to biopsy lesions or mediastinal lymph nodes for disease staging.

Diagnosis of Suspected Lung Cancer Involving Solitary or Peripheral Pulmonary Lesions

Covered when clinically appropriate for the lesion and procedure.

Diagnosis of solitary or peripheral pulmonary lesions

A solitary or peripheral pulmonary lesion is present in an individual with suspected lung cancer.
EBUS or EBUS-guided biopsy is used for diagnosis.
Selection is influenced by lesion size, location, and procedural risk. Evidence does not establish that EBUS is superior to alternative biopsy techniques.

Diagnosis of Suspected Lung Cancer with Extensive Mediastinal Infiltration and No Extrathoracic Metastatic Disease

Covered when all of the following criteria are met.

Diagnosis with extensive mediastinal infiltration

The individual is suspected of having lung cancer.
Radiographic studies show extensive infiltration of the mediastinum.
There is no evidence of extrathoracic metastatic disease.Negative PET scan
Diagnosis is established by the least invasive and safest method, which may include bronchoscopy with TBNA or EBUS-guided needle aspiration.
ACCP recommendation grade 1C.

Diagnosis of a Peripheral Pulmonary Nodule When Tissue Diagnosis Is Required

Covered when all of the following criteria are met.

Peripheral pulmonary nodule requiring tissue diagnosis

The individual is suspected of having lung cancer and has a peripheral lung nodule.
Tissue diagnosis is required because of diagnostic uncertainty or poor surgical candidacy.Tissue diagnosis required
Radial EBUS is used as an adjunct imaging modality.
ACCP recommendation grade 1C.

Mediastinal Staging in Diagnosed Lung Cancer with Suspected N2/N3 Involvement and No Distant Metastases

Covered when all of the following criteria are met.

High-suspicion mediastinal staging

The individual has diagnosed lung cancer.
There is high suspicion of N2 or N3 involvement based on discrete mediastinal lymph-node enlargement or PET uptake.High suspicion of N2/N3 involvement
There are no distant metastases.No distant metastases
EBUS-NA, EUS-NA, or combined EBUS/EUS-NA is used as the best first test over surgical staging.
ACCP recommendation grade 1B.

Escalation to Surgical Staging When High Suspicion Persists After a Negative Needle-Based Result

Surgical staging is indicated when all of the following circumstances apply.

Persistent suspicion after negative needle sampling

Clinical suspicion of mediastinal node involvement remains high.
A needle technique, such as EBUS-NA, EUS-NA, or combined EBUS/EUS-NA, has produced a negative result.
Surgical staging, such as mediastinoscopy or video-assisted thoracic surgery, is performed.
ACCP recommendation grade 1B.

Diagnosis of Peripheral Pulmonary Nodules

Covered when all of the following criteria are met.

Peripheral pulmonary nodule requiring tissue diagnosis

The individual is suspected of having lung cancer and has a peripheral lung nodule.
Tissue diagnosis is required because of diagnostic uncertainty or poor surgical candidacy.Tissue diagnosis required
Radial EBUS is used as an adjunct imaging modality.

Diagnosis in Suspected Lung Cancer with Extensive Mediastinal Infiltration

Covered when all of the following criteria are met.

Extensive mediastinal infiltration

The individual is suspected of having lung cancer.
Radiographic studies show extensive mediastinal infiltration.
There is no evidence of extrathoracic metastatic disease.Negative PET scan
EBUS-NA is used as one of the least invasive and safest diagnostic methods.

Mediastinal Staging in Lung Cancer

Covered when all of the following criteria are met.

Suspected N2/N3 nodal disease

The individual has diagnosed lung cancer.
There is high suspicion of N2 or N3 involvement based on discrete mediastinal lymph-node enlargement or PET uptake.
There are no distant metastases.No distant metastases
EBUS-NA, EUS-NA, or combined EBUS/EUS-NA is used as the best first test over surgical staging.

NCCN-Supported Diagnostic or Nodal Biopsy

Covered when the least invasive biopsy with the highest yield is selected as the first diagnostic study.

ONE of

Pulmonary nodule: A pulmonary nodule is present and radial EBUS is used for diagnostic biopsy.Pulmonary nodule
Suspected nodal disease is present and EBUS is used for biopsy.Suspected nodal disease

Evaluation of Peripheral Pulmonary Lesions in Individuals with Suspected Lung Cancer

EBUS-TBNA may be considered medically necessary when all of the following criteria are met.

Peripheral pulmonary lesion evaluation

The individual has suspected lung cancer.
Tissue biopsy of the peripheral pulmonary lesion is required for diagnosis.
The peripheral pulmonary lesion is not accessible using standard bronchoscopic techniques.

Mediastinal Staging in Individuals with Diagnosed Lung Cancer

EBUS-TBNA may be considered medically necessary when all of the following criteria are met.

Mediastinal staging

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

Submit Clinical Review Documentation

Before EBUS-TBNA, submit clinical review documentation supporting the indication and medical necessity of the procedure.

History and physical and/or consultation notes.
Reason for EBUS-TBNA.
Treatment plan.
Prior imaging results.

Documentation Required

Complete Post-Service Documentation

After the service, provide the procedure report(s) in addition to the clinical review documentation submitted for the indication.

Include the completed EBUS-TBNA procedure report(s).

Documentation Required

Submit the Procedure Report

Submit the procedure report(s) after the service together with the previously required history, physical, consultation, indication, treatment-plan, and imaging documentation.

Post-service procedure reports are required in addition to the clinical review documentation.

Denial Risk

Peripheral Lesion Criteria Must Be Met

For evaluation of a peripheral pulmonary lesion in suspected lung cancer, coverage may be denied when either required criterion is not documented.

A tissue biopsy of the peripheral pulmonary lesion is not required for diagnosis.
The peripheral pulmonary lesion is accessible using standard bronchoscopic techniques.

Denial Risk

Mediastinal Staging Criteria Must Be Met

For mediastinal staging in diagnosed lung cancer, coverage may be denied when any required criterion is not documented.

The individual is not suitable or willing to undergo specific lung-cancer treatment with curative or palliative intent.
Tissue biopsy of abnormal mediastinal lymph nodes seen on imaging is not required for staging and specific treatment planning.
The abnormal mediastinal lymph nodes are not accessible by EBUS-TBNA.

Denial Risk

Investigational Use Outside Covered Criteria

Endobronchial ultrasound is investigational for lung-cancer diagnosis or staging when the applicable peripheral-lesion or mediastinal-staging criteria are not met, and it is investigational for indications outside those criteria.

Do not represent EBUS-TBNA as medically necessary when the stated diagnostic or staging requirements are unmet.
Other indications are investigational under the policy.

Denial Risk

Follow the Updated Policy Pathway

Apply the updated policy pathway by confirming that EBUS-TBNA is used for an eligible peripheral pulmonary lesion evaluation or mediastinal staging indication and that every applicable medical-necessity criterion is supported in the record. If the criteria are not met—or the procedure is performed for another indication—classify the use as investigational.

Peripheral-lesion evaluation requires a biopsy for diagnosis and lack of access by standard bronchoscopic techniques.
Mediastinal staging requires treatment suitability and willingness, a biopsy requirement for staging and specific treatment planning, and node accessibility by EBUS-TBNA.
The policy does not establish medical necessity for diagnosis or staging outside these pathways.

Obtains tissue samples from peripheral pulmonary lesions or mediastinal lymph nodes.

Definition

TermMediastinal staging

AssessmentAssessment of the extent of lung cancer, including evaluation of mediastinal lymph nodes and distant metastatic disease.

PurposeGuides treatment planning.

Definition

TermRadial probe EBUS

TransducerA rotating 20- or 30-MHz transducer that produces high-resolution 360-degree radial images.

Sampling limitationIt can localize a peripheral lesion, but the probe is retracted and replaced by a biopsy or sampling device because it does not provide real-time imaging during biopsy.

Definition

TermConvex probe EBUS

TransducerA 5- to 12-MHz transducer incorporated into a dedicated bronchoscope.

CapabilityProvides real-time 50- to 60-degree sector views and enables visualization and needle aspiration of a lesion, including mediastinal lymph nodes.

Definition

TermEBUS-TBNA

Expanded termEndobronchial ultrasound-guided transbronchial needle aspiration.

PurposeIsolates and biopsies pulmonary lesions for diagnosis and staging of detected lung cancers.

Definition

TermClinical validity

DetectionA test detects the presence or absence of a condition.

Additional valid usesA test may detect future risk of developing a condition or treatment response, including beneficial or adverse response.

Definition

TermClinically useful

Management impactTest results inform management decisions that improve the net health outcome of care.

ExamplesImprovement may occur when patients receive correct or more effective therapy or avoid unnecessary therapy or testing.

Definition

TermEBUS-TBNA as an adjunct to standard bronchoscopy

Expanded termEndobronchial ultrasound-guided transbronchial needle aspiration.

UseUsed with standard bronchoscopy for diagnosis or staging of lung cancer.

Definition

TermClinically valid

Condition detectionA test detects the presence or absence of a condition.

Risk or responseA test may detect future risk of developing a condition or treatment response, including beneficial or adverse response.

Definition

TermClinically useful

Decision supportTest results inform management decisions that improve the net health outcome of care.

Patient benefitThe net health outcome may improve through correct or more effective therapy or by avoiding unnecessary therapy or testing.

Definition

TermEBUS-TBNA for tissue sampling and mediastinal staging

Expanded termEndobronchial ultrasound-guided transbronchial needle aspiration.

UseUsed for tissue sampling and mediastinal staging in the lung cancer setting, after lung cancer is diagnosed.

Definition

AbbreviationEBUS

MeaningEndobronchial ultrasound.

Policy contextEBUS-guided needle aspiration is identified as a needle technique for mediastinal staging.

Definition

AbbreviationPET

MeaningPositron emission tomography.

Staging contextPET uptake in mediastinal lymph nodes may indicate high suspicion of N2 or N3 involvement.

Definition

TermEBUS-TBNA

Expanded termEndobronchial ultrasound-guided transbronchial needle aspiration.

ApplicationUsed for diagnosing lung cancer and for mediastinal staging through transbronchial needle aspiration.

Definition

TermEBUS-NA

Expanded termEndobronchial ultrasound-guided needle aspiration.

Clinical useA least-invasive needle aspiration method that may be used to establish a diagnosis of lung cancer, including in patients with extensive mediastinal infiltration and no extrathoracic metastatic disease.