Summary & Overview
CPT 0611U: Plasma cfDNA Methylation Assay for Liver Cancer Risk Assessment
CPT code 0611U is a Proprietary Laboratory Analyses (PLA) code specific to Helio Genomics®' HelioHCCTMStrat test, a plasma-based cell–free DNA methylation assay that analyzes more than 1,000 genomic regions and yields a quantitative score for liver cancer detection or risk assessment. As a PLA code, 0611U denotes a single-manufacturer, single-test identifier used for laboratory reporting and payer adjudication. Nationally, such PLA codes matter because they enable payers and providers to track utilization and coverage of novel, proprietary diagnostics tied to a specific company's test.
Key payers included in the analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context for the assay, the service and typical site of service, and what to expect in payer engagement. The publication summarizes available benchmarks and coverage themes, highlights policy considerations for PLA-coded molecular diagnostics, and outlines the clinical role of cfDNA methylation profiling in liver cancer detection and risk assessment.
This summary is intended for national audiences seeking a streamlined briefing on CPT code 0611U, its clinical application, and the payer landscape for a proprietary plasma-based methylation assay targeting liver cancer.
Billing Code Overview
CPT code 0611U is a Proprietary Laboratory Analyses (PLA) code reported only for HelioHCCTMStrat from Helio Genomics®. The test evaluates cell–free DNA (cfDNA) methylation patterns across more than 1,000 genomic regions from plasma and uses a proprietary algorithm to produce a quantitative measure related to liver cancer detection or risk assessment.
Service Type: Laboratory — molecular diagnostic, cfDNA methylation profiling for liver cancer detection/risk assessment
Typical Site of Service: Clinical laboratory or reference laboratory; specimen collected in an outpatient or phlebotomy setting with plasma-based testing performed by the reporting laboratory
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with chronic liver disease (for example, cirrhosis from hepatitis B, hepatitis C, nonalcoholic steatohepatitis, or long-standing alcohol-related liver disease) who is enrolled in a hepatology surveillance program. The clinician orders the proprietary plasma-based methylation assay 0611U (HelioHCCTMStrat by Helio Genomics®) to assess cell-free DNA methylation patterns as an adjunctive test for liver cancer detection or risk stratification. Blood is drawn in an outpatient phlebotomy setting or hospital laboratory and sent to the manufacturer-specific laboratory for specialized sequencing and bioinformatic analysis. Results, reported as a quantitative algorithm score indicating likelihood or risk related to hepatocellular carcinoma (HCC), are returned to the ordering hepatologist, gastroenterologist, or primary care clinician and incorporated into the patient’s surveillance plan alongside imaging (ultrasound, CT, or MRI), serum alpha-fetoprotein measurement, and clinical assessment. Typical workflow steps: order entry by clinician, patient consent and phlebotomy at an ambulatory laboratory, specimen handling and shipment per manufacturer instructions, laboratory analytic processing, report generation, and clinician review to inform surveillance intensity or further diagnostic imaging.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When billing for the physician professional interpretation portion if separated from the lab's global claim (rare for PLA tests but used if applicable). |