CPT code 0009U designates DEPArray™ HER2 by PacificDx, a Proprietary Laboratory Analyses (PLA) test that isolates tumor cells and performs fluorescence in situ hybridization (FISH) to report HER2 (ERBB2) gene amplification. The code captures a manufacturer‑specific laboratory service used in oncology diagnostics to guide targeted therapy decisions and treatment planning. Nationally, PLA codes like 0009U matter because they document proprietary assays with single‑source ownership and can affect coverage, coding consistency, and lab reimbursement policies.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical context for HER2 FISH testing, the service setting and workflow implications, and typical payer considerations. The publication outlines available benchmarks and policy elements related to proprietary laboratory analyses, notes common modifier usage where applicable, and highlights areas where payers often require documentation or prior authorization. The content is intended for billing professionals, laboratory directors, and policy analysts seeking a concise reference on the clinical purpose, billing classification, and payer landscape for CPT code 0009U. Data not available in the input for associated taxonomies, ICD‑10 diagnoses, and related codes are noted where applicable.