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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0611UCPTProprietary Laboratory AnalysescfDNA methylationmolecular diagnosticsliver cancerHelio Genomicslaboratory testing

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).
`TC`	Technical component	When reporting only the technical component from the performing laboratory (used if separate technical billing occurs).
`59`	Distinct procedural service	When another unrelated test or service is performed on the same date and needs to be identified as distinct.
`91`	Repeat clinical diagnostic laboratory test	When the same assay is repeated on the same day on the same patient for confirmation.
`QW`	CLIA-waived test indicator (not typically applicable)	Only used if a waived test; generally not used for high-complexity PLA tests like `0611U`.
`GH`	Services related to an organ transplant (hospital inpatient)	If specimen collection is related to transplant care and required by institutional billing rules.
`XE`	Separate encounter	When the specimen collection or service represents a separate encounter from other services billed the same day.
`XP`	Separate practitioner	When a different practitioner performed the portion of service than the one billing another claim.
`KX`	Requirements specified in medical policy have been met	When payer-specific coverage criteria are met and need attestation for medical necessity.
`GA`	Waiver of liability statement issued, patient refused to pay	When the patient has signed an Advance Beneficiary Notice or equivalent and the provider bills accordingly.
`GZ`	Item or service expected to be denied as not reasonable and necessary	When the test is billed without an ABN and is expected to be denied under medical necessity rules.

Taxonomy Code	Specialty	Notes
`207RH0000X`	Hepatology	Specialists most commonly ordering liver-specific molecular testing for HCC risk assessment.
`207RC0000X`	Gastroenterology	Routinely manages chronic liver disease and surveillance where this test is used.
`207Q00000X`	Internal Medicine	Primary care physicians managing chronic liver disease and coordinating surveillance.
`208000000X`	Pathology	May be involved in test interpretation or institutional laboratory coordination.
`3336C0002X`	Clinical Molecular Genetics Laboratory	Specialty lab providers or directors overseeing genomic assays and reporting.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`K74.60`	Unspecified cirrhosis of liver	Cirrhosis is a primary risk state prompting hepatocellular carcinoma surveillance where `0611U` may be ordered.
`K75.9`	Inflammatory liver disease, unspecified	Chronic inflammatory liver disease may lead to surveillance testing for HCC risk assessment.
`B18.2`	Chronic viral hepatitis C	Chronic hepatitis C infection increases HCC risk and is a common indication for adjunctive molecular testing.
`B18.1`	Chronic viral hepatitis B without delta-agent	Chronic hepatitis B carrier state with HCC risk surveillance applicability.
`E78.5`	Hyperlipidemia, unspecified (as a component of metabolic syndrome/NASH risk)	Metabolic risk factors such as NASH-related disease increase HCC risk and inform testing decisions.
`K76.0`	Fatty (change of) liver, not elsewhere classified	Nonalcoholic fatty liver disease and NASH are common indications for surveillance and molecular risk assessment.
`R94.5`	Abnormal results of liver function studies	Abnormal liver tests often trigger further risk stratification, including specialized molecular assays.
`Z13.6`	Encounter for screening for cardiovascular disorders (screening code placeholder)	Used when patients are asymptomatic but undergoing screening surveillance programs; may be adapted in clinical workflows for surveillance enrollment.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0611U`	HelioHCCTMStrat — plasma cell-free DNA methylation assay for liver cancer detection/risk assessment (proprietary PLA code)	The index laboratory test; performed by the manufacturer-specific lab and reported using this PLA code.
`81479`	Unlisted molecular pathology procedure	May be used historically for novel molecular tests before a PLA code existed or for ancillary custom analyses not covered by the PLA code.
`86140`	Alpha-fetoprotein (AFP) measurement	Commonly ordered alongside `0611U` as a serum tumor marker used in liver cancer surveillance.
`76700`	Ultrasound, abdominal, real time with image documentation; limited	Imaging commonly performed for HCC surveillance or follow-up when molecular test results suggest increased risk.
`74177`	CT abdomen and pelvis with contrast, diagnostic	Cross-sectional imaging used when surveillance imaging or molecular results prompt further diagnostic evaluation.
`74181`	MRI abdomen without contrast; followed by with contrast (or `74183` as appropriate)	Advanced imaging for lesion characterization after positive surveillance markers or concerning molecular assay results.

Beta

OpenPayer Beta

Summary & Overview

CPT 0611U: Plasma cfDNA Methylation Assay for Liver Cancer Risk Assessment

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0611UCPTProprietary Laboratory AnalysescfDNA methylationmolecular diagnosticsliver cancerHelio Genomicslaboratory testing

Billing Code Overview

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

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).
`TC`	Technical component	When reporting only the technical component from the performing laboratory (used if separate technical billing occurs).
`59`	Distinct procedural service	When another unrelated test or service is performed on the same date and needs to be identified as distinct.
`91`	Repeat clinical diagnostic laboratory test	When the same assay is repeated on the same day on the same patient for confirmation.
`QW`	CLIA-waived test indicator (not typically applicable)	Only used if a waived test; generally not used for high-complexity PLA tests like `0611U`.
`GH`	Services related to an organ transplant (hospital inpatient)	If specimen collection is related to transplant care and required by institutional billing rules.
`XE`	Separate encounter	When the specimen collection or service represents a separate encounter from other services billed the same day.
`XP`	Separate practitioner	When a different practitioner performed the portion of service than the one billing another claim.
`KX`	Requirements specified in medical policy have been met	When payer-specific coverage criteria are met and need attestation for medical necessity.
`GA`	Waiver of liability statement issued, patient refused to pay	When the patient has signed an Advance Beneficiary Notice or equivalent and the provider bills accordingly.
`GZ`	Item or service expected to be denied as not reasonable and necessary	When the test is billed without an ABN and is expected to be denied under medical necessity rules.

Taxonomy Code	Specialty	Notes
`207RH0000X`	Hepatology	Specialists most commonly ordering liver-specific molecular testing for HCC risk assessment.
`207RC0000X`	Gastroenterology	Routinely manages chronic liver disease and surveillance where this test is used.
`207Q00000X`	Internal Medicine	Primary care physicians managing chronic liver disease and coordinating surveillance.
`208000000X`	Pathology	May be involved in test interpretation or institutional laboratory coordination.
`3336C0002X`	Clinical Molecular Genetics Laboratory	Specialty lab providers or directors overseeing genomic assays and reporting.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`K74.60`	Unspecified cirrhosis of liver	Cirrhosis is a primary risk state prompting hepatocellular carcinoma surveillance where `0611U` may be ordered.
`K75.9`	Inflammatory liver disease, unspecified	Chronic inflammatory liver disease may lead to surveillance testing for HCC risk assessment.
`B18.2`	Chronic viral hepatitis C	Chronic hepatitis C infection increases HCC risk and is a common indication for adjunctive molecular testing.
`B18.1`	Chronic viral hepatitis B without delta-agent	Chronic hepatitis B carrier state with HCC risk surveillance applicability.
`E78.5`	Hyperlipidemia, unspecified (as a component of metabolic syndrome/NASH risk)	Metabolic risk factors such as NASH-related disease increase HCC risk and inform testing decisions.
`K76.0`	Fatty (change of) liver, not elsewhere classified	Nonalcoholic fatty liver disease and NASH are common indications for surveillance and molecular risk assessment.
`R94.5`	Abnormal results of liver function studies	Abnormal liver tests often trigger further risk stratification, including specialized molecular assays.
`Z13.6`	Encounter for screening for cardiovascular disorders (screening code placeholder)	Used when patients are asymptomatic but undergoing screening surveillance programs; may be adapted in clinical workflows for surveillance enrollment.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0611U`	HelioHCCTMStrat — plasma cell-free DNA methylation assay for liver cancer detection/risk assessment (proprietary PLA code)	The index laboratory test; performed by the manufacturer-specific lab and reported using this PLA code.
`81479`	Unlisted molecular pathology procedure	May be used historically for novel molecular tests before a PLA code existed or for ancillary custom analyses not covered by the PLA code.
`86140`	Alpha-fetoprotein (AFP) measurement	Commonly ordered alongside `0611U` as a serum tumor marker used in liver cancer surveillance.
`76700`	Ultrasound, abdominal, real time with image documentation; limited	Imaging commonly performed for HCC surveillance or follow-up when molecular test results suggest increased risk.
`74177`	CT abdomen and pelvis with contrast, diagnostic	Cross-sectional imaging used when surveillance imaging or molecular results prompt further diagnostic evaluation.
`74181`	MRI abdomen without contrast; followed by with contrast (or `74183` as appropriate)	Advanced imaging for lesion characterization after positive surveillance markers or concerning molecular assay results.