CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Navigational Bronchoscopy

Defines medical necessity and noncoverage for electromagnetic navigation bronchoscopy (ENB) for Medicare Advantage and commercial products, including diagnostic biopsy of peripheral pulmonary lesions and placement of fiducial markers; excludes use for mediastinal lymph node diagnosis and other unaddressed uses.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNavigational Bronchoscopy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionProvider should document that flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective when submitting for ENB (medical necessity requirement).

SourceLink

POLICY UPDATE CHANGES

No material changes — has_material_change=false

2Medically Necessary Indications

1Not Covered: Mediastinal LN

2Coding Guidance Items

Coverage Summary

Scope summary: Defines medical necessity and noncoverage for electromagnetic navigation bronchoscopy (ENB) for Medicare Advantage and commercial products, including diagnostic biopsy of peripheral pulmonary lesions and placement of fiducial markers; excludes use for mediastinal lymph node diagnosis and other unaddressed uses.

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Medical-Necessity Criteria

Medicare Advantage Plans and Commercial Products - 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 ONE of the following is met:

ANY of the following

Diagnosis of peripheral pulmonary lesions (CPT 31627): Establish a diagnosis of suspicious peripheral pulmonary lesion(s) (CPT code 31627).
Fiducial marker placement (CPT 31626): Place fiducial markers within lung tumor(s) prior to treatment (CPT code 31626).

Medicare Advantage Plans - Not Covered Indications

ENB is not covered for the following:

Not Covered (Medicare Advantage)

Mediastinal lymph node diagnosis: Use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes.
Other unaddressed uses: All other uses not addressed as medically necessary above.

Commercial Products - Not Medically Necessary Indications

ENB is not medically necessary for the following:

Not Medically Necessary (Commercial)

Mediastinal lymph node diagnosis: Use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes.
Other unaddressed uses: All other uses not addressed as medically necessary above.

Coding

Medically Necessary CPT Codes (when criteria 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 Coding GuidanceCPT

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 flexible bronchoscopy/EBUS

Provider should document that flexible bronchoscopy alone, or with endobronial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective when submitting for ENB (medical necessity requirement).

31626
31627

Billing Rule

Report ENB with appropriate CPT

Report 31627 in addition to the primary bronchoscopy procedure; report 31626 for fiducial marker placement; use an unlisted procedure code when reporting ENB for mediastinal lymph node diagnosis (no specific CPT exists).

31626
31627
unlisted

Background & Evidence

ENB is intended to enhance standard bronchoscopy by providing a 3-dimensional roadmap of the lungs and real-time information about the position of the steerable probe during bronchoscopy to allow navigation to distal regions so suspicious lesions can be biopsied and fiducial markers placed.

RCT and case series (mediastinal lymph nodes): For individuals with enlarged mediastinal lymph nodes who received ENB with flexible bronchoscopy, evidence includes a randomized controlled trial and case series; the RCT showed higher sampling and diagnostic success with ENB-guided transbronchial needle aspiration versus conventional TBNA, but endobronchial ultrasound (EBUS) was not used as the comparator and diagnostic accuracy for malignancy was not reported, leading to insufficient evidence of net health benefit.

Systematic reviews/meta-analyses: Multiple systematic reviews and meta-analyses have evaluated diagnostic yield and safety of ENB for pulmonary nodules and peripheral lesions.

NAVIGATE study: The prospective, multicenter NAVIGATE study and subsequent analyses (including 1,000-subject and 24-month reports) are referenced as real-world evidence on ENB diagnostic yield and fiducial placement feasibility and safety.

Electromagnetic navigation bronchoscopy (ENB): A bronchoscopy enhancement providing a 3-dimensional roadmap and real-time probe positioning to navigate to distal lung regions for biopsy or fiducial marker placement.

Not Covered / Not Medically Necessary

Explicit exclusion: Use of ENB with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes is not covered / not medically necessary.

All other uses not addressed as medically necessary (i.e., any indication other than diagnosing suspicious peripheral pulmonary lesions or placing fiducial markers when flexible bronchoscopy alone or with EBUS is inadequate) are also excluded.