Summary & Overview

CPT 0414U: AI-Based Lung Tumor Mutation Profiling

CPT code 0414U is a Proprietary Laboratory Analyses (PLA) code assigned exclusively to the LungOI test from Imagene. The test applies artificial intelligence to digitized H&E-stained FFPE lung tumor slides to evaluate mutations across at least eight specified genes and reports each as positive or negative. As a PLA code, 0414U identifies a single manufacturer-specific laboratory service and is relevant to payers managing coverage for advanced, commercially developed molecular diagnostics.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical purpose and typical laboratory site of service, a summary of payer coverage considerations, and context on billing and coding implications for a PLA-designated assay. The publication highlights benchmarking topics useful to health plans and providers—coverage scope, coding and billing practices for single-source tests, and the clinical role of digital pathology and AI in lung tumor molecular profiling.

This national-level summary provides operational and policy context rather than state-specific guidance. Data not available in the input are noted where applicable in the detailed sections.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0414UCPTproprietary laboratory analysesdigital pathologyAI molecular profilinglung tumorpathology labmolecular diagnosticsH&E FFPE

Billing Code Overview

CPT code 0414U is a Proprietary Laboratory Analyses (PLA) code specific to a single commercial test, reported only for LungOI from Imagene. The test analyzes digitized pathology slides from formalin–fixed paraffin–embedded (FFPE) lung tumor tissue stained with hematoxylin and eosin (H&E). Using artificial intelligence (AI) with algorithms and bioinformatics databases, the assay evaluates the slide for mutations in at least eight genes listed in the code and reports each gene result as positive or negative.

Service type: Laboratory — pathology-based, AI-driven molecular profiling

Typical site of service: Clinical laboratory or pathology laboratory processing digitized FFPE surgical pathology slides

Clinical & Coding Specifications

Clinical Context

A 68-year-old patient with a newly diagnosed primary lung mass undergoes diagnostic bronchoscopy with transbronchial biopsy. Formalin-fixed paraffin-embedded (FFPE) tissue from the tumor is processed and stained with hematoxylin and eosin (H&E) in the pathology lab. The pathology laboratory digitizes the slide and submits the digital H&E image to the proprietary LungOI assay from Imagene, billed with 0414U. The LungOI test uses artificial intelligence algorithms and bioinformatics databases to evaluate the tumor morphology and infer mutation status for a panel of at least eight genes, reporting each as positive or negative. Results are used by the treating oncologist and molecular tumor board to inform targeted therapy selection, clinical trial eligibility, or additional molecular testing. Typical sites of service include hospital outpatient pathology or independent clinical laboratory settings where FFPE blocks and H&E slides are prepared and scanned. The service type is a laboratory molecular/biomarker diagnostic test performed on digitized pathology images rather than direct sequencing of DNA/RNA.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when only the professional (interpretation) component of the diagnostic report is billed separately from technical processing.

Taxonomy Code	Specialty	Notes
2082S0001X	Anatomic/Clinical Pathology	Pathologists supervise slide interpretation and sign out diagnostic reports.
207K00000X	Medical Oncology	Oncologists order the LungOI assay to guide targeted therapy selection.
2086S0125X	Molecular Genetic Pathology	Specialists oversee molecular test validation, interpretation, and integration with genomic data.
363L00000X	Diagnostic Radiology	Interventional radiologists perform CT-guided biopsies that yield the FFPE tissue.
207L00000X	Surgical Oncology	Surgeons procure tissue during resection procedures that may be submitted for the assay.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Primary lung cancer diagnoses for which tumor tissue is tested with LungOI to evaluate actionable mutations.
`C34.11`	Malignant neoplasm of upper lobe, right bronchus or lung	Site-specific lung cancer commonly yielding biopsy specimens submitted for molecular and AI-based testing.
`C34.12`	Malignant neoplasm of middle lobe, right bronchus or lung	Lung tumor location that may be biopsied and analyzed with the assay to inform systemic therapy.
`C34.31`	Malignant neoplasm of upper lobe, left bronchus or lung	Left-sided primary lung cancers evaluated with tissue-based diagnostic assays.
`C78.01`	Secondary malignant neoplasm of right lung	Metastatic lesions to the lung where characterization of oncogenic drivers may guide treatment choices.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Commonly billed for initial histopathologic evaluation of the biopsy specimen and H&E slide preparation before digitization for the LungOI test.
`88342`	Immunohistochemistry, per single antibody stain	May be performed alongside to characterize tumor markers that complement AI-based mutation inferences.
`88361`	Image capture, review, and interpretation, per study	Used when digital slide imaging and primary image interpretation services are billed; related to the slide digitization step prior to LungOI analysis.
`88399`	Unlisted pathology procedure and service	Occasionally used for novel or proprietary image-analysis services if a specific PLA code is not available, though `0414U` is the correct PLA code for LungOI.
`88350`	Microscopic examination, consultation second opinion	May be used when an external pathology consult is requested in conjunction with the diagnostic workflow that leads to ordering the LungOI assay.