Electromagnetic Navigation-Guided Bronchoscopy
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Clinical policy governing medical necessity, coverage, and investigational status of electromagnetic navigation-guided bronchoscopy for diagnosis and related uses in members covered by Aetna.
No material clinical or coverage changes in this revision.
Coverage Criteria - Electromagnetic Navigation-guided Bronchoscopy (ENB)
Medical Necessity - EN-guided bronchoscopy
Covered when ALL of the following are met:
From Medical Necessity statement.
Experimental and Investigational
Not covered / considered experimental and investigational:
Listed as experimental/investigational due to insufficient evidence.
Situations supporting use of ENB
Clinical evidence and circumstances in which ENB is used or considered (supporting coverage when documentation shows ALL relevant clinical factors):
Synthesis from guidelines and NAVIGATE cohort evidence.
Comparative evidence caveats
Factors that may argue against ENB or that require justification when opting for ENB instead of alternatives:
Based on NICE assessment, UpToDate and guideline summaries.
Specific EN-guided procedures are identified in the policy as experimental and investigational. These explicitly include: cone-beam CT (CBCT) augmented EN-guided bronchoscopy for biopsy of indeterminate pulmonary nodules; EN bronchoscopy-guided microwave ablation for treatment of pulmonary nodules; and trans-bronchial lung cryo-biopsy when used to improve the diagnostic yield of digital tomosynthesis–assisted EN-guided bronchoscopic biopsy. These approaches are listed as investigational because effectiveness has not been established.
The document does not list additional explicit exclusions beyond the investigational procedures named elsewhere. NICE (2019) is cited to note that comparative evidence finds ENB has lower diagnostic yield than CT-guided TTNA but lower pneumothorax rates, and that the role of ENB among other guided bronchoscopy techniques is not yet established — indicating that further evidence is needed before broader adoption or definitive placement within diagnostic pathways.
When EN-guided bronchoscopy is combined with cone-beam CT, the policy highlights resource and radiation implications. CBCT-equipped procedure rooms are costly and require additional staff training, and CBCT use exposes patients to additional radiation (average ~3.5 CBCT spins per procedure reported). If the additional radiation exposure cannot be justified and discussed with the patient, this may be a basis for limiting use or for denial of the combined CBCT-augmented approach.
Available assessments and guidelines indicate that data are insufficient to show ENB reliably avoids surgical biopsy in patients who are surgical candidates. A VA technology assessment concluded that low negative predictive value limits confidence that ENB can replace surgical biopsy, so ENB should not be relied on to avoid indicated surgical procedures in those candidates.
This policy segment does not use explicit 'not medically necessary' wording for ENB in general; however, comparative evidence limitations are emphasized. Because ENB often has lower diagnostic yield than CT-guided transthoracic needle aspiration and randomized superiority data are lacking, the absence of documented justification for choosing ENB over an appropriate alternative (e.g., CT-guided biopsy when feasible) may result in non-coverage or denial when the selection criteria are not met.
Coding and Billing Guidance
| 31627 | Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with computer-assisted, image-guided navigation (List separately in addition to code for primary procedure[s]). |
| 31615 | Tracheobronchoscopy through established tracheostomy incision. |
| 31622 | Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; diagnostic, with cell washing, when performed (separate procedure). |
| 31623 | with brushing or protected brushings. |
| 31624 | with bronchial alveolar lavage. |
| 31625 | with bronchial or endobronchial biopsy(s), single or multiple sites. |
| 31626 | with placement of fiducial markers, single or multiple. |
| 31628 | with transbronchial lung biopsy(s), single lobe. |
| 31629 | with transbronchial needle aspiration biopsy(s), trachea, main stem and/or lobar bronchus(i). |
| 31630 | with tracheal/bronchial dilation or closed reduction of fracture. |
| 31631 | with placement of tracheal stent(s) (includes tracheal/bronchial dilation as required). |
| C7509 | Bronchoscopy, rigid or flexible, diagnostic with cell washing(s) when performed, with computer-assisted image-guided navigation, including fluoroscopic guidance when performed. |
| C7510 | Bronchoscopy, rigid or flexible, with bronchial alveolar lavage(s), with computer-assisted image-guided navigation, including fluoroscopic guidance when performed. |
| C7511 | Bronchoscopy, rigid or flexible, with single or multiple bronchial or endobronchial biopsy(ies), single or multiple sites, with computer-assisted image-guided navigation, including fluoroscopic guidance when performed. |
| R91.1 | Solitary pulmonary nodule [peripheral pulmonary nodule]. |
| R91.8 | Other nonspecific abnormal finding of lung field [peripheral pulmonary nodules]. |
| no specific code | Electromagnetic navigation bronchoscopy-guided microwave ablation; Cone-beam CT augmented electromagnetic navigation (EN)-guided bronchoscopy; Trans-bronchial lung cryo-biopsy for improvement of diagnostic yield of digital tomosynthesis-assisted EN-guided bronchoscopic biopsy — listed as not covered/experimental. |
| No specific CPT/HCPCS/ICD-10 codes listed in this document segment |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required when billing EN-guided bronchoscopy codes. Submit prior authorization with clinical documentation that selection criteria for medical necessity are met (per policy: peripheral pulmonary nodule requiring pathologic diagnosis and not accessible by standard bronchoscopy or transthoracic biopsy).
- Affected codes: CPT 31627 and related bronchoscopy procedure codes; HCPCS C7509–C7511. ICD-10 examples: R91.1, R91.8.
Prior Authorization Expectation
Prior authorization may be appropriate when ENB is planned for biopsy, fiducial placement, dye marking, or lymph node sampling. Provide a clear clinical rationale for the planned use and target lesion(s).
- Document intended procedure: diagnostic biopsy, fiducial placement (CPT 31626), or lymph node sampling (e.g., TBNA).
- If ENB is used adjunctively (e.g., for dye marking), explain why alternatives are unsuitable.
Prior Authorization for Combined/Novel ENB Procedures
If ENB is proposed to guide adjunctive or novel interventions (for example, microwave ablation, cone-beam CT augmentation, or other combined procedures), submit prior authorization and document the rationale and intended combined procedure.
- Examples: ENB-guided microwave ablation (investigational per policy), ENB combined with VATS or CBCT confirmation. Note: some combined procedures are considered experimental/investigational; see policy.
- Provide evidence supporting use and anticipated benefit over standard approaches.
Indication Mismatch Risk
Denials may occur if the indication does not match the policy (e.g., not a peripheral pulmonary nodule requiring pathologic diagnosis) or if the lesion is accessible by standard bronchoscopy or by transthoracic biopsy approaches.
- Confirm indication: solitary/peripheral pulmonary nodule (ICD-10 R91.1 or R91.8) requiring tissue diagnosis.
- If lesion is reachable by standard bronchoscopy or TTNA with acceptable risk, document why ENB is preferred.
Comparative Evidence and Denial Risk
Comparative evidence indicates ENB-guided biopsy has lower diagnostic yield than CT-guided transthoracic needle aspiration (TTNA) but lower pneumothorax rates. Absent justification of benefit or patient-specific rationale, requests may be denied.
- Reference assessments (e.g., NICE) showing lower diagnostic yield vs TTNA but lower complication rates.
- If choosing ENB over TTNA, document patient-specific risks for TTNA and why ENB is preferred.
CBCT-Related Resource and Radiation Concerns
When cone-beam CT (CBCT) is used with ENB, document justification given CBCT-related resource needs and additional radiation exposure. Failure to justify access to CBCT or additional radiation may increase denial risk.
- Document expected benefit of CBCT confirmation (improved localization/real-time confirmation) and number of anticipated CBCT spins.
- If CBCT resources are limited, note plans for resource sharing or ancillary staff training and patient discussion of radiation risk.
Clinical and Coding Documentation
Clinical and coding documentation must support the diagnosis and medical necessity. Include codes and diagnosis rationale (e.g., ICD-10 R91.1 or R91.8) and state that the peripheral pulmonary nodule is not accessible by standard bronchoscopy.
- Include primary ICD-10 diagnosis (e.g., R91.1), planned CPT/HCPCS codes, and clinical reason ENB is required.
- Ensure coding aligns with the actual procedures performed and any add-on/navigation codes are listed appropriately.
Lesion Characteristics and Tissue Needs
Documentation should include lesion size, location, and the need for adequate tissue for histologic and molecular characterization. Provide the rationale for choosing ENB to obtain sufficient tissue for diagnosis and molecular testing.
- Lesion metrics: maximum diameter (mm/cm), lobe and segment location, presence/absence of bronchus sign.
- State diagnostic goals: histology, immunohistochemistry, and molecular tests required (e.g., for NSCLC).
Required Procedural Documentation
Procedural documentation must record lesion characteristics, navigational modalities used, biopsy tools and the sequence of sampling, and any adjunct imaging or confirmation techniques.
- Record navigational modalities: ENB, RP-EBUS, CBCT, fluoroscopy.
- List biopsy tools and sequence (example sequence from pilot studies: TBNA, then forceps, then TBLC) and number of passes per tool.
- Document whether fiducials were placed, dye marking performed, or adjunctive ablation attempted.
Consideration of Alternative Diagnostic Modalities
Document that alternative diagnostic modalities (e.g., TTNA, rEBUS, conventional bronchoscopy) were considered and why they were not appropriate or were less desirable for this patient.
- If TTNA was considered, document specific patient risk factors that make TTNA high risk.
- If rEBUS or conventional bronchoscopy considered, document lesion features that limit their utility (e.g., peripheral location, lack of bronchus sign).
Suggested Sequential Biopsy Approach
A sequential biopsy approach may be considered and should be documented when used. Pilot studies have used TBNA first, then forceps biopsy, and finally trans-bronchial lung cryo-biopsy (TBLC) to maximize diagnostic yield.
- If sequential sampling is planned, list the intended order of modalities and rationale.
- Document results of each sampling method and any change in approach during the procedure.
Background and Clinical Context
Conventional flexible bronchoscopy is limited by bronchoscope diameter and the branching anatomy of the airways, which constrains access to small peripheral lesions. Diagnostic yield with standard bronchoscopy decreases notably for small lesions (several studies and guideline statements highlight lower yields for lesions ~20 mm). ENB was developed as a CT-based, image-guided navigation technique to guide a locatable probe and instruments through the bronchoscope to peripheral lung lesions, potentially improving access and enabling procedures such as fiducial placement and targeted biopsy.
Definitions and Study Descriptions
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