CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

CPT code 0611U is a Proprietary Laboratory Analyses (PLA) CPT code that reports the HelioHCCTMStrat test from Helio Genomics®, a plasma cell‑free DNA methylation assay analyzing patterns across more than 1,000 genomic regions to generate an algorithmic quantitative measure related to liver cancer detection or risk assessment; service type: laboratory molecular diagnostic test (cell‑free DNA methylation analysis); typical site of service: clinical laboratory or reference diagnostic laboratory with blood draw/processing performed in an outpatient or ambulatory phlebotomy setting.

Customize your policy alerts

Sign up for cpt 0611U policy alerts

Get alerted when payer policies referencing 0611U are released or updated.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Explore openpayer tools

View all tools

CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

Customize your policy alerts

Sign up for cpt 0611U policy alerts

Get alerted when payer policies referencing 0611U are released or updated.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

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.

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.

Related Modifiers

5 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
P6	Modifier P6 indicates a declared brain‑dead patient whose organs are being removed for donor purposes. It is part of the Anesthesia Physical Status Modifiers (P1–P6) and corresponds to ASA VI. The…	- When to use: Append CPT modifier P6 to anesthesia codes in the 00100–01999 range when the anesthesia provider documents a declared brain‑dead patient whose organs are being removed for donor…
73	Modifier 73 indicates a facility-level outpatient hospital or ASC procedure that was discontinued after the patient was prepared and taken to the procedure/operating room but before any anesthesia…	- When to use: Apply CPT modifier 73 on the FACILITY (outpatient hospital or ASC) claim when the patient has been fully prepared and physically taken into the procedure/operating room but the…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
207RH0000X	Hematology (Internal Medicine) Physician	An internist with additional training who specializes in diseases of the blood, spleen and lymph. This specialist treats conditions such as anemia, cl…
207RC0000X	Cardiovascular Disease Physician	An internist who specializes in diseases of the heart and blood vessels and manages complex cardiac conditions such as heart attacks and life-threaten…
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
3336C0002X	Clinic Pharmacy	A pharmacy in a clinic, emergency room or hospital (outpatient) that dispenses medications to patients for self-administration under the supervision o…
251E00000X	Home Health Agency	A public agency or private organization, or a subdivision of such an agency or organization, that is primarily engaged in providing skilled nursing se…
103TM1800X	Intellectual & Developmental Disabilities Psychologist	Behavioral Health & Social Service Providers · Psychologist
207ZD0900X	Dermatopathology (Pathology) Physician	A dermatopathologist is an expert in diagnosing and monitoring diseases of the skin including infectious, immunologic, degenerative, and neoplastic di…

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Explore openpayer tools

View all tools

Clinical & Coding Specifications

Clinical Context

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.

Related Modifiers

5 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
59	Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…	- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
91	Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…	- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
P6	Modifier P6 indicates a declared brain‑dead patient whose organs are being removed for donor purposes. It is part of the Anesthesia Physical Status Modifiers (P1–P6) and corresponds to ASA VI. The…	- When to use: Append CPT modifier P6 to anesthesia codes in the 00100–01999 range when the anesthesia provider documents a declared brain‑dead patient whose organs are being removed for donor…
73	Modifier 73 indicates a facility-level outpatient hospital or ASC procedure that was discontinued after the patient was prepared and taken to the procedure/operating room but before any anesthesia…	- When to use: Apply CPT modifier 73 on the FACILITY (outpatient hospital or ASC) claim when the patient has been fully prepared and physically taken into the procedure/operating room but the…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
207RH0000X	Hematology (Internal Medicine) Physician	An internist with additional training who specializes in diseases of the blood, spleen and lymph. This specialist treats conditions such as anemia, cl…
207RC0000X	Cardiovascular Disease Physician	An internist who specializes in diseases of the heart and blood vessels and manages complex cardiac conditions such as heart attacks and life-threaten…
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
3336C0002X	Clinic Pharmacy	A pharmacy in a clinic, emergency room or hospital (outpatient) that dispenses medications to patients for self-administration under the supervision o…
251E00000X	Home Health Agency	A public agency or private organization, or a subdivision of such an agency or organization, that is primarily engaged in providing skilled nursing se…
103TM1800X	Intellectual & Developmental Disabilities Psychologist	Behavioral Health & Social Service Providers · Psychologist
207ZD0900X	Dermatopathology (Pathology) Physician	A dermatopathologist is an expert in diagnosing and monitoring diseases of the skin including infectious, immunologic, degenerative, and neoplastic di…

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

OpenPayer

CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

Sign up for cpt 0611U policy alerts

OpenPayer

CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

Sign up for cpt 0611U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

References

CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

Sign up for cpt 0611U policy alerts

CPT 0611U: cfDNA Methylation Assay for Liver Cancer Detection

Sign up for cpt 0611U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

What does CPT code 0611U represent?

In which clinical scenarios is 0611U typically ordered?

Where and how is the 0611U test performed and processed?

What related CPT codes might be billed in conjunction with 0611U?

Which modifiers are relevant when billing 0611U and when are they used?

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Codes

What does CPT code 0611U represent?

In which clinical scenarios is 0611U typically ordered?

Where and how is the 0611U test performed and processed?

What related CPT codes might be billed in conjunction with 0611U?

Which modifiers are relevant when billing 0611U and when are they used?

References