Summary & Overview
CPT 0612U: Plasma cfDNA Methylation Assay for Liver Cancer Risk
CPT code 0612U is a Proprietary Laboratory Analyses (PLA) code reserved for the HelioHCCTMTrace assay from Helio Genomics®. The test performs high-dimensional methylation profiling of cell–free DNA from plasma across more than 1,000 genomic regions and reports an algorithm-derived quantitative measure related to liver cancer detection or risk assessment. As a PLA code, 0612U identifies a single manufacturer's proprietary laboratory test, which has implications for coding specificity, coverage determinations, and payer policy reviews nationally.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and service setting for the assay, and a national-oriented review of considerations that affect adoption and payment: benchmark practices for PLA codes, typical places of service for cfDNA-based diagnostics, and the types of documentation and clinical context payers commonly request. The publication summarizes available policy trends and benchmarking approaches relevant to proprietary molecular diagnostics without state-level detail.
This resource is intended to clarify what CPT code 0612U represents, who it applies to, and what topics stakeholders should expect when evaluating coverage or billing for a proprietary cfDNA methylation assay for liver cancer detection or risk assessment.
Billing Code Overview
CPT code 0612U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the HelioHCCTMTrace test from Helio Genomics®. The test analyzes cell–free DNA (cfDNA) from plasma for methylation patterns across more than 1,000 genomic regions. Test results are combined into an algorithm that produces a quantitative measure related to liver cancer detection or risk assessment.
Service type: Proprietary laboratory molecular diagnostic assay (cfDNA methylation profiling) performed on plasma.
Typical site of service: Clinical laboratory or reference laboratory; sample collection occurs in outpatient phlebotomy settings or other sites where blood draws are performed.
Data not available in the input for common modifiers, associated taxonomies, ICD-10 diagnoses, related codes, and service line.
Clinical & Coding Specifications
Clinical Context
A typical patient scenario involves an adult with risk factors for hepatocellular carcinoma (HCC) such as chronic hepatitis B or C infection, cirrhosis from alcohol or nonalcoholic fatty liver disease, or a history of hepatic lesions on imaging. A hepatology or oncology clinician orders 0612U (HelioHCCTMTrace) as a blood-based molecular assay to assess cell-free DNA methylation patterns when imaging results are indeterminate, when enhanced surveillance is desired, or to provide additional risk stratification for early detection of liver cancer.
Workflow: the clinician documents the indication in the electronic health record, obtains informed consent for laboratory testing, and places a venipuncture order. A phlebotomist draws a plasma sample using required collection and handling protocols and ships it to the performing laboratory (Helio Genomics®). The lab performs cfDNA extraction, methylation analysis across >1,000 genomic regions, and applies the proprietary algorithm to produce a quantitative result. Results are returned to the ordering clinician and incorporated into the patient’s management plan (surveillance imaging interval adjustment, referral to hepatology/oncology, or additional diagnostic workup). Typical site of service is an outpatient clinic, ambulatory diagnostic center, or hospital outpatient laboratory with specimen transport to the performing central lab.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the physician interpretation component if applicable and the lab arrangement separates professional and technical components. |
TC | Technical component | Use when billing only the technical component if the performing laboratory bills separately from the ordering provider. |
90 | Reference (outside) laboratory | Use when the service is performed by a provider other than the billing entity (e.g., send-out to Helio Genomics®). |
91 | Repeat clinical diagnostic laboratory test | Use when a repeat of the identical test is performed on the same date for quality control or verification per payer rules. |
59 | Distinct procedural service | Use when reporting another unrelated lab or service on the same day that is distinct and separately billable. |
25 | Significant, separately identifiable evaluation and management service | Use when an E/M visit on the same day is separate from ordering the test and requires separate billing. |
24 | Unrelated E/M service by the same physician during postoperative period | Use when the test is ordered for a condition unrelated to a recent surgical global period. |
32 | Mandated services | Use when the test is ordered because of a public health or other mandate requiring testing. |
53 | Discontinued procedure | Use if specimen collection was started but the procedure was discontinued for documented clinical reasons. |
99 | Multiple modifiers — placeholder for uncommon payer-specific modifiers | Use only per payer guidance when additional modifiers are required (note: list depends on insurer-specific rules). |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RC0000X | Internal Medicine | Primary clinicians ordering surveillance and risk assessment for liver disease. |
207RH0000X | Hepatology | Specialists managing liver disease who commonly order HCC surveillance testing. |
207RX0201X | Medical Oncology | Oncologists who evaluate patients with suspected or treated liver malignancies. |
208D00000X | Diagnostic Laboratory | Clinical laboratory providers performing or coordinating the send-out testing and reporting results. |
363A00000X | Phlebotomy | Providers or services responsible for specimen collection and handling. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
K74.60 | Unspecified cirrhosis of liver | Cirrhosis is a major risk factor for hepatocellular carcinoma and a common indication for surveillance testing like 0612U. |
B18.2 | Chronic viral hepatitis C | Chronic hepatitis C increases HCC risk and prompts enhanced surveillance or molecular risk assessment. |
B18.1 | Chronic viral hepatitis B without delta-agent | Chronic hepatitis B is a key indication for liver cancer screening and molecular testing. |
K76.9 | Liver disease, unspecified | Used when liver pathology is present but not yet fully characterized; may support ordering of 0612U. |
R93.5 | Abnormal tumor markers, unspecified | Applied when laboratory or imaging findings raise concern for malignancy and additional molecular testing is ordered. |
C22.0 | Liver cell carcinoma | Diagnosis for confirmed hepatocellular carcinoma; 0612U may be used in assessment or risk stratification contexts prior to definitive diagnosis. |
Z85.05 | Personal history of malignant neoplasm of liver and intrahepatic bile ducts | Used for surveillance of recurrence risk where 0612U may contribute to monitoring strategies. |
Z72.0 | Tobacco use | Risk factor that may be documented in the clinical context when assessing overall cancer risk and surveillance planning. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0612U | HelioHCCTMTrace — cfDNA methylation assay for liver cancer detection (Proprietary Laboratory Analyses) | Primary PLA code to report this specific test performed by Helio Genomics®. |
36415 | Collection of venous blood by venipuncture | Performed immediately prior to 0612U to obtain plasma specimen for analysis. |
86328 | Therapeutic drug assay by enzyme immunoassay (EIA) | Example laboratory code for other lab work that might be ordered same day; separate reporting if performed. |
81002 | Urinalysis, non-automated, without microscopy | Ancillary outpatient test that may be ordered during the same visit; billed separately if performed. |
86480 | Tunic test (immunoassay) | Representative of serologic testing (e.g., hepatitis serologies) commonly performed alongside risk assessment for hepatocellular carcinoma. |
88172 | Cytopathology, limited evaluation (e.g., FNA immediate adequacy) | May relate when tissue sampling or focal lesion assessment follows an abnormal 0612U result. |
Note: When billing, use 90 for send-out to the performing laboratory and separate specimen-collection codes such as 36415 where applicable.