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.
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. |