CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Electromagnetic Navigational Bronchoscopy

Defines medical necessity and non-coverage positions for electromagnetic navigation bronchoscopy (ENB) for Medicare Advantage and commercial products, including diagnostic use for peripheral pulmonary lesions and fiducial marker placement; excludes ENB for mediastinal lymph node diagnosis and other unaddressed uses.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Electromagnetic Navigational Bronchoscopy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review Date

Key ActionDocument that flexible bronchoscopy alone, or with endobronchial ultrasound, are inadequate to accomplish the diagnostic or interventional objective before ENB is considered medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

2Primary Covered Indications

1Primary Excluded Indication (mediastinal lymph node diagnosis)

Coverage Summary

Overview: This policy (effective 2020-01-01, last reviewed 2024-07-17) defines medical necessity and non-coverage positions for Electromagnetic Navigation Bronchoscopy (ENB). The coverage stance is mixed: ENB is supported as medically necessary in specified situations (diagnosis of suspicious peripheral pulmonary lesions and placement of fiducial markers when standard bronchoscopy/EBUS are inadequate) and is considered not covered/not medically necessary for other uses, including diagnosis of mediastinal lymph nodes. Glossary: ENB — Electromagnetic navigation bronchoscopy (see definition block).

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Medical-Necessity Criteria

Medically Necessary Indications

ENB may be considered medically necessary when flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective and ALL of the following apply:

ALL of the following

ALL of the following
- ONE of the following procedural objectives
  - Establish a diagnosis of suspicious peripheral pulmonary lesion(s) (report with CPT code 31627)
  - Place fiducial markers within tumor(s) for treatment (report with CPT code 31626)

Not Medically Necessary / Not Covered

ENB is considered not covered or not medically necessary for the following uses:

ANY of the following

Use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes (Medicare Advantage Plans)
Use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes (Commercial Products)
All other uses not addressed as medically necessary above

Coding

Medically Necessary Codes (when conditions in policy statement met)CPTCovered

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 (List separately in addition to code for primary procedure)

Unlisted Procedure for Mediastinal Lymph Node DiagnosisCPT

unlisted

No specific CPT code(s) for electromagnetic navigation bronchoscopy when used for the diagnosis of mediastinal lymph nodes; providers should report this service with an unlisted procedure code

Provider Actions

Documentation Required

Document inadequacy of standard bronchoscopy/EBUS

Provider must have documentation that flexible bronchoscopy alone, or with endobronchial ultrasound, are inadequate to accomplish the diagnostic or interventional objective before ENB is considered medically necessary.

Documentation must show flexible bronchoscopy alone or with EBUS is inadequate.

Billing Rule

Use correct CPT code(s)

Report fiducial placement with CPT 31626 and computer-assisted image-guided navigation with CPT 31627 (list 31627 separately in addition to code for the primary procedure). There is no specific CPT code for ENB when used to diagnose mediastinal lymph nodes; providers should report this service with an unlisted procedure code.

Affected codes: 31626, 31627, unlisted procedure code
31627 should be listed separately in addition to the primary procedure
Use an unlisted code for ENB when diagnosing mediastinal lymph nodes (no specific CPT exists)

Denial Risk

Potential denial for mediastinal node diagnosis

Claims for ENB used to diagnose mediastinal lymph nodes or for other uses not addressed as medically necessary may be denied as not covered or not medically necessary due to insufficient evidence of improved net health outcome.

Claims for ENB to diagnose mediastinal lymph nodes may be denied as not covered or not medically necessary.
Other uses not addressed as medically necessary may also be denied for insufficient evidence.

Background & Evidence

Background/Clinical role: Electromagnetic navigation bronchoscopy (ENB) provides a 3-dimensional roadmap and real-time positioning to navigate to distal pulmonary lesions for biopsy and to place fiducial markers. ENB is used as an adjunct to standard flexible bronchoscopy (and may be used when bronchoscopy with or without endobronchial ultrasound is considered inadequate) to increase diagnostic yield for peripheral pulmonary nodules and to enable bronchoscopic placement of fiducial markers for radiotherapy. CPT guidance notes reporting of fiducial placement (CPT 31626) and computer-assisted image-guided navigation (CPT 31627), with an unlisted code recommended when ENB is used for mediastinal lymph node diagnosis because no specific CPT exists.

Evidence summary: For ENB used to sample enlarged mediastinal lymph nodes, the published evidence includes a randomized controlled trial and case series. The RCT reported higher sampling and diagnostic success with ENB-guided transbronchial needle aspiration compared with conventional transbronchial needle aspiration, but endobronchial ultrasound (EBUS) — a superior comparator to conventional TBNA — was not used. Diagnostic accuracy for identifying malignancy was not reported in the RCT or uncontrolled studies. Conclusion: Insufficient evidence to demonstrate improvement in net health outcome for ENB diagnosis of mediastinal lymph nodes; therefore ENB for mediastinal node diagnosis is considered not covered / not medically necessary.

Definition — ENB: Electromagnetic navigation bronchoscopy (ENB) uses computer-assisted, image-guided navigation to access peripheral pulmonary lesions and place fiducial markers.