Summary & Overview
CPT 0019U: RNA Expression–Based Tumor Profiling and Therapeutic Matching
CPT code 0019U designates a Proprietary Laboratory Analyses (PLA) test—OncoTarget and OncoTreat—that measures RNA gene expression in tumors and uses an algorithm to match molecular activity patterns with potential therapeutic agents. As a PLA code, 0019U refers to a single manufacturer-specific/laboratory-specific assay, which matters nationally as precision oncology assays increasingly inform targeted treatment decisions and coverage determinations. The code signals a complex molecular diagnostic service that may intersect with medical oncology, pathology, and precision medicine programs.
Key payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical purpose of the test, the service setting, common billing modifiers, and what to expect from payer engagement at a national level. The publication summarizes benchmarks and coverage themes relevant to proprietary molecular assays, highlights policy updates affecting PLA codes broadly, and provides clinical context about how RNA expression–based matching tools are used in treatment planning. The content aims to help billing staff, laboratory administrators, and policy analysts understand the coding designation, typical site-of-service, and the national payer landscape for CPT code 0019U.
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Billing Code Overview
CPT code 0019U is a Proprietary Laboratory Analyses (PLA) code that describes a single, specific laboratory test: OncoTarget and OncoTreat developed by DarwinHealth in collaboration with the Columbia University Department of Pathology and Cell Biology. The test evaluates RNA gene expression in tumor tissue and applies a computational algorithm to match tumor activity signatures with potential therapeutic agents.
Service Type: Laboratory molecular diagnostic test with algorithmic therapeutic matching
Typical Site of Service: Clinical laboratory or hospital outpatient laboratory
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Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with metastatic, treatment-refractory colorectal adenocarcinoma presents to a tertiary cancer center for precision oncology testing to guide systemic therapy selection. Prior lines of standard chemotherapy and targeted agents produced limited response; the oncology team requests a molecular functional assay to evaluate tumor biology and predict drug sensitivity. A formal pathology review identifies an adequate formalin-fixed paraffin-embedded (FFPE) tumor block or recent core biopsy specimen. The specimen is sent to the proprietary laboratory performing the OncoTarget and OncoTreat assay described by 0019U.
The laboratory extracts RNA from the tumor sample, performs gene expression profiling, and applies the vendor algorithm to map tumor transcriptional activity to drugs and drug classes with predicted efficacy. Results are returned as a report listing prioritized therapeutic agents and pathways with supporting evidence. The treating oncologist reviews the report in a multidisciplinary tumor board, documents clinical interpretation, and integrates recommendations into the next-line treatment plan. Billing for the assay is submitted using PLA code 0019U with appropriate diagnosis codes reflecting the patient’s malignancy and clinical status. Typical site of service is an outpatient cancer center, pathology lab, or reference laboratory performing specialized molecular testing.
Coding Specifications
| Modifier | Description | When to Use |
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