Summary & Overview
CPT 0069U: miR–31–3p Expression Test for Colon Cancer
Headline: New CPT code 0069U designates the proprietary miR–31now™ molecular test for colon cancer tissue
Lead: CPT code 0069U identifies a manufacturer-specific molecular diagnostic assay — the miR–31now™ test from GoPath Laboratories — which measures miR–31–3p expression in formalin–fixed, paraffin–embedded colon cancer specimens and reports an algorithm-derived expression score intended to inform treatment decisions.
What the code represents and national importance: CPT code 0069U is a Proprietary Laboratory Analyses (PLA) code that codifies a single-company laboratory test used in the molecular characterization of colon cancer. As precision oncology testing expands, discrete PLA codes like 0069U enable clearer tracking of utilization, facilitate payer adjudication, and support data collection on adoption of tumor-directed biomarkers nationwide.
Key payers covered in the analysis: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication provides benchmarks and context for CPT code 0069U, summarizes payer coverage landscapes, and outlines clinical context for use of the miR–31now™ assay. It addresses coding specifics, typical site-of-service considerations, and what information is available for payers and providers. Data not available in the input will be noted as such where applicable.
Billing Code Overview
CPT code 0069U is a Proprietary Laboratory Analyses (PLA) code for the miR–31now™ test performed by GoPath Laboratories. The test measures miR–31–3p expression in formalin–fixed, paraffin–embedded colon cancer tissue and uses an algorithm to assign an expression score to guide treatment therapy decisions.
Service type: Laboratory — molecular diagnostic test
Typical site of service: Clinical laboratory or reference pathology laboratory; specimen collected in an outpatient or inpatient setting and submitted to the laboratory
Clinical & Coding Specifications
Clinical Context
A typical patient is a 60-year-old individual with a histologically confirmed stage II–III colon adenocarcinoma who has undergone surgical resection of the primary tumor. Tumor tissue fixed in formalin and embedded in paraffin (FFPE) is submitted to GoPath Laboratories for the miR–31now™ test. The laboratory extracts RNA from the FFPE block, measures miR–31–3p expression, and applies the proprietary algorithm to generate an expression score. The report is used by the treating medical oncologist to inform selection of systemic therapy, particularly in the context of decisions about anti–EGFR therapy versus alternative regimens for metastatic or recurrent disease. Typical workflow steps include: specimen accessioning, histology review to confirm tumor content, RNA extraction and assay run, algorithmic scoring, and result reporting to the ordering oncologist. Typical site of service is a clinical molecular diagnostics laboratory supporting outpatient oncology care; specimen collection originates from hospital outpatient surgical pathology or an ambulatory surgical setting.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation component if separated from the technical laboratory component (rare for PLA codes but applicable when professional-only reporting occurs). |