Summary & Overview
CPT 0333U: HelioLiver™ Test — cfDNA and Protein Markers for Early Liver Cancer Detection
CPT code 0333U designates the HelioLiver™ Test, a Proprietary Laboratory Analyses (PLA) molecular diagnostic performed on whole blood to evaluate cell–free DNA and protein tumor markers for early detection of liver cancer in high-risk patients. As a PLA code, 0333U represents a single, manufacturer-specific assay and carries distinct coding and coverage considerations for payers and providers nationwide. Nationally, the code matters because it supports adoption of a targeted, noninvasive screening option for a population with elevated liver cancer risk and informs payer policy and utilization management.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise review of the clinical purpose and laboratory service model for the test, payer coverage themes and benchmark considerations, and the coding context for billing and claim submission. The publication summarizes typical sites of service, expected service line classification, and common modifier usage when applicable. It also outlines the clinical context for use — whole blood-based cfDNA plus protein marker assessment for early liver cancer detection in high-risk patients — and points readers to where to look for payer-specific policy details. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0333U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the HelioLiver™ Test from Fulgent Genetics LLC and Helio Health Inc. The HelioLiver™ Test uses a whole blood specimen to evaluate circulating cell–free DNA (cfDNA) and protein tumor markers to assist in the early detection of liver cancer in patients at high risk for the disease.
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Service type: Laboratory molecular diagnostic test combining cfDNA analysis and protein tumor marker assessment
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Typical site of service: Clinical laboratory or reference laboratory processing whole blood specimens
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with cirrhosis from chronic hepatitis C and long-standing alcohol-related liver disease presents for routine surveillance for hepatocellular carcinoma (HCC). The patient is enrolled in a high-risk surveillance program and their clinician orders the HelioLiver™ test to augment ultrasound and alpha-fetoprotein monitoring. A whole blood specimen is collected during an outpatient phlebotomy visit or at the clinic, labeled per laboratory requirements, and shipped to the performing laboratory. The laboratory performs the Proprietary Laboratory Analysis (PLA) under 0333U, evaluating cell-free DNA (cfDNA) biomarkers and protein tumor markers to detect molecular signals associated with early liver cancer. Results are reported to the ordering clinician and incorporated into the patient’s surveillance plan alongside imaging and clinical assessment. Typical sites of service include outpatient clinics, ambulatory phlebotomy centers, and independent clinical laboratories. Service type: Clinical laboratory pathology/Proprietary Laboratory Analysis delivered by a certified clinical laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional interpretation component performed by a physician separate from the laboratory technical process. |