Summary & Overview
CPT 0523U: oncoReveal™ CDx 22‑Gene Solid Tumor Sequencing Assay
Headline: New CPT code 0523U designates the proprietary oncoReveal™ CDx 22‑gene solid tumor sequencing assay
Lead: CPT code 0523U is a Proprietary Laboratory Analyses (PLA) code reserved for the oncoReveal™ CDx test from Pillar Biosciences Inc., a targeted next‑generation sequencing assay that detects single‑nucleotide variants and small insertions/deletions in 22 cancer‑related genes. The code standardizes billing for this single‑manufacturer companion diagnostic across payers.
What the code represents and why it matters: CPT code 0523U identifies a specific laboratory‑developed or proprietary tumor genomic profiling test used in oncology to characterize somatic mutations. Nationally, designation as a PLA code clarifies which clinical assay is billed, supports consistent claims processing for that one test, and aids tracking of utilization for precision oncology diagnostics.
Key payers covered: The analysis addresses national payer approaches including Aetna, Blue Cross Blue Shield plans, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication provides benchmarks for adoption and reimbursement patterns, summaries of payer coverage considerations and policy language where available, and clinical context for the test’s role in tumor genotyping and potential treatment selection. It also documents common billing considerations tied to PLA reporting.
Scope: Content is national in focus and intended for billing managers, molecular laboratory directors, and policy teams seeking a concise reference on CPT code 0523U.
Billing Code Overview
CPT code 0523U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the oncoReveal™ CDx test from Pillar Biosciences Inc. The assay analyzes solid tumor tissue to detect single–nucleotide variants and insertions or deletions across 22 genes. Results are reported as identified mutations with details on genomic location, nucleotide changes, and amino acid changes.
Service Type: Laboratory molecular diagnostic assay — tumor genomic profiling
Typical Site of Service: Clinical laboratory or pathology/laboratory setting
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a newly diagnosed metastatic non-small cell lung carcinoma (NSCLC) undergoes tumor profiling to guide targeted therapy selection. The treating oncologist orders the oncoReveal™ CDx assay to analyze a formalin-fixed paraffin-embedded (FFPE) solid tumor specimen obtained from a prior core needle biopsy. The clinical workflow: the pathology laboratory confirms specimen adequacy and sends the sample to the performing laboratory or manufacturer for testing; the oncoReveal™ CDx test (0523U) performs next-generation sequencing to detect single‑nucleotide variants and small insertions/deletions across 22 cancer-related genes; the laboratory issues a report listing detected mutations with genomic coordinates, nucleotide and amino-acid changes, and interpretation regarding potential actionable targets or resistance variants. Results are reviewed by the oncology care team to inform systemic therapy selection, clinical trial eligibility, or additional molecular testing. Typical site of service includes an outpatient pathology or molecular diagnostics laboratory, and specimens originate from hospital outpatient clinics, ambulatory surgery centers, or physician offices arranging shipment to the performing lab.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified modifier (placeholder in list) | Rarely used in billing systems; not typically appended to PLA codes unless vendor-specific guidance requires a default. |