Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesLaboratory/PathologyBlue KC serum fibrosis testing Coverage Update | O…
    Ask Trek AI about this page
    CurrentBlue KCPolicy POL-PP-309

    Serum Testing for Hepatic Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease

    Customize your policy alerts

    Sign up for Blue KC Policy POL-PP-309 alerts

    Get alerted when Policy POL-PP-309 changes without checking for updates manually.

    Monitor payer policy activity

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

    Defines reimbursement policy for serum multianalyte assays with algorithmic analysis and individual serum biomarkers used to evaluate or monitor hepatic fibrosis in chronic liver disease across Blue KC product lines. Specifies which proprietary tests may be reimbursed (FibroSURE/FibroTest, ELF/FibroTest) under certain clinical contexts and lists biomarkers/tests that do not meet coverage criteria.

    Policy Summary
    PayerBlue KC
    PolicySerum Testing for Hepatic Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease
    Policy CodePolicy POL-PP-309
    Change TypeAvalon 4th Quarter updates
    Effective DateOct 1, 2025
    Last ReviewOct 1, 2025
    Next Review DateOct 1, 2026
    Key ActionEnsure the assay is ordered for one of the covered indications and document indication; reimbursement for FibroSURE/FibroTest/ELF limited to once every 6 months.
    SourceLink
    POLICY UPDATE CHANGES

    Initial version created 07/01/2025; Avalon 4th Quarter updates on 10/01/2025 produced version 002 effective 10/01/2025.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    3Primary covered indications (HBV, HCV, MASLD/MASH/alcoholic hepatitis)
    >=6 monthsMinimum interval for reimbursed testing
    10+Listed CPT/HCPCS/PLA/Category III codes referenced

    Coverage Summary

    Scope: Defines reimbursement policy for serum multianalyte assays with algorithmic analysis and individual serum biomarkers used to evaluate or monitor hepatic fibrosis in chronic liver disease across Blue KC product lines. Coverage stance: mixed — certain proprietary assays are covered in specified clinical contexts while other multianalyte assays and individual biomarkers do not meet coverage criteria. Headline covered proprietary assays and contexts: FibroSURE/FibroTest (including HBV FibroSURE, HCV FibroSURE) and ELF (ELFTM) may be reimbursed for individuals with chronic hepatitis B (HBV) or chronic hepatitis C (HCV) (testing once every 6 months), and ELF or FibroTest may be reimbursed (once every 6 months) for individuals with metabolic dysfunction-associated steatotic liver disease (MASLD, including MASH), alcoholic hepatitis, or when performed to rule out compensated advanced chronic liver disease (cACLD) in individuals with an elevated liver stiffness measurement. Policy status: CURRENT / Active. Effective date: 10/01/2025; Last review: 10/01/2025; Next review: 10/01/2026.

    Testing frequency for reimbursed assaysonce every 6 months
    Elevated liver stiffness measurementrequired (no numeric threshold specified)
    Primary covered indications3

    Medical Necessity / Reimbursement Criteria

    Covered when ALL of the following are met

    Reimbursement criteria for multianalyte assays ELF or FibroTest/FibroSURE

    ALL of the following

    • Chronic viral hepatitis indication: Individual has chronic hepatitis B (HBV) or chronic hepatitis C (HCV) viral infection

      For these individuals, FibroSURE (HBV FibroSURE, HCV FibroSURE), ELF (ELFTM) or FibroTest testing once every 6 months may be reimbursed

    • Testing frequencyonce every 6 months

      Applies to FibroSURE (HBV/HCV), ELF, or FibroTest

    Covered when ANY of the following are met

    Reimbursement criteria for ELF or FibroTest/FibroSURE in other specified conditions

    ANY of the following

    Coding

    Covered / Described proprietary tests and associated codesCPTCovered
    81596Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver. Proprietary test: HCV FibroSURE™, FibroTest™. Laboratory/Manufacturer: BioPredictive S.A.S.
    81517Liver disease, analysis of 3 biomarkers (hyaluronic acid [HA], procollagen III amino terminal peptide [PIIINP], tissue inhibitor of metalloproteinase 1 [TIMP-1]), using immunoassays, utilizing serum, prognostic algorithm reported as a risk score and risk of liver fibrosis and liver-related clinical events within 5 years.
    0002MLiver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH). Proprietary test: ASH FibroSURE™. Laboratory/Manufacturer: BioPredictive S.A.S.
    0003MLiver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH). Proprietary test: NASH FibroSURE™. Laboratory/Manufacturer: BioPredictive S.A.S.
    0166ULiver disease, 10 biochemical assays (α2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, GGT, ALT, AST, triglycerides, cholesterol, fasting glucose) and biometric and demographic data, utilizing serum, algorithm reported as scores for fibrosis, necroinflammatory activity, and steatosis with a summary interpretation. Proprietary test: LiverFASt™. Lab/Manufacturer: Fibronostics.
    0344UHepatology (nonalcoholic fatty liver disease [NAFLD]), semiquantitative evaluation of 28 lipid markers by liquid chromatography with tandem mass spectrometry (LC-MS/MS), serum, reported as at-risk for nonalcoholic steatohepatitis (NASH) or not NASH. Proprietary test: OWLiver®. Lab/Manufacturer: CIMA Sciences, LLC.
    0468UHepatology (nonalcoholic steatohepatitis [NASH]), miR-34a5p, alpha 2-macroglobulin, YKL40, HbA1c, serum and whole blood, algorithm reported as a single score for NASH activity and fibrosis. Proprietary test: NASHnext™ (NIS4™).
    81599Unlisted multianalyte assay with algorithmic analysis.
    84999Unlisted chemistry procedure.
    0000Placeholder/unlisted code referenced in source content; use only when no specific CPT code accurately describes the proprietary multianalyte assay being billed. Billing with 0000 requires documentation of test methodology, analytes included, algorithm description, and justification that no existing specific code applies.
    Unlisted / Not-specific codes used for non-covered assaysCPT
    81599Unlisted multianalyte assay with algorithmic analysis.
    84999Unlisted chemistry procedure.

    Provider Actions & Billing Guidance

    Prior Authorization

    Reimbursement limited to specified clinical indications

    Ensure the ordered assay is for one of the covered clinical indications (chronic HBV or HCV; MASLD/MASH; alcoholic hepatitis; or to rule out compensated advanced chronic liver disease [cACLD] in individuals with an elevated liver stiffness measurement). Reimbursement for FibroSURE/FibroTest/ELF is limited to testing performed for these indications and to a frequency of once every 6 months.

    • Affected codes: 81596
    • Affected codes: 0166U
    • Affected codes: 81517
    Billing Rule

    Do not bill non-reimbursed multianalyte assays

    Do not bill for other multianalyte assays with algorithmic analysis or the listed individual biomarkers when they are not part of an approved reimbursable assay. Examples such assays (e.g., ASH FibroSURE®, LIVERFAStTM, NASH FibroSURE®, OWLiver®) and services billed with unlisted codes (81599, 84999) may be denied if representing non-covered tests.

    Background

    Background: Biomarkers of extracellular matrix turnover (glycoproteins, collagen family members, collagenases and their inhibitors, and fibrogenic cytokines) are used to assess hepatic fibrosis and may be utilized individually or in panel combinations. The policy distinguishes reimbursable proprietary multianalyte assays — specifically FibroSURE/FibroTest and ELF (ELFTM) — which may be reimbursed in specified clinical contexts and at a frequency of once every 6 months, from other algorithmic multianalyte tests and individual serum biomarkers that do not meet coverage criteria due to insufficient published evidence.

    Non-reimbursable algorithmic multianalyte assays (examples) include ASH FibroSURE®, LIVERFAStTM, NASH FibroSURE®, OWLiver®, LiverFASt™ and other tests described by unlisted codes; these and other multianalyte assays with algorithmic analysis may not be reimbursed except when they are components of one of the approved reimbursable assays. Individual serum biomarkers listed in the policy (e.g., hyaluronic acid, type III procollagen [PCIII], type IV collagen, laminin, miRNA analyses, CHI3L1, MFAP4, plasma caspase-generated cytokeratin-18, SIPA1L1) do not meet coverage criteria when used outside the context of an approved multianalyte assay because of a lack of published evidence supporting clinical utility.

    Definitions:

    MASLD: Metabolic dysfunction-associated steatotic liver disease (includes MASH).

    cACLD: Compensated advanced chronic liver disease.

    ELF: Enhanced Liver Fibrosis test (ELFTM).

    Revision History

    07/01/2025initial_version

    Initial version created (Revision 001; Original creation date 7/1/2025).

    10/01/2025updateLatest

    Avalon 4th Quarter updates produced Version 002 effective 10/01/2025 (policy status: Active).

    Policy Summary
    PayerBlue KC
    PolicySerum Testing for Hepatic Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease
    Policy CodePolicy POL-PP-309
    Change TypeAvalon 4th Quarter updates
    Effective DateOct 1, 2025
    Last ReviewOct 1, 2025
    Next Review DateOct 1, 2026
    Key ActionEnsure the assay is ordered for one of the covered indications and document indication; reimbursement for FibroSURE/FibroTest/ELF limited to once every 6 months.
    SourceLink
    On This Page
    Coverage SummaryMedical Necessity / Reimbursement CriteriaCodingProvider Actions & Billing GuidanceBackgroundRevision History
    MASLD/MASH: Individual has metabolic dysfunction-associated steatotic liver disease (MASLD), including metabolic dysfunction-associated steatohepatitis (MASH)
  1. Alcoholic hepatitis: Individual has alcoholic hepatitis
  2. Rule out cACLD with elevated liver stiffness: Testing is performed to rule out compensated advanced chronic liver disease (cACLD) for individuals with an elevated liver stiffness measurement

    ELF (ELFTM) or FibroTest testing once every 6 months may be reimbursed in these situations

  3. Testing frequencyonce every 6 months

    4. Not covered / Does not meet coverage criteria

    Use of other multianalyte assays with algorithmic analysis or specified individual biomarkers

    Not covered assays and biomarkers

    • Non-reimbursed multianalyte assay examples: Other multianalyte assays with algorithmic analysis (examples: ASH FibroSURE®, LIVERFAStTM, NASH FibroSURE®, OWLiver®) may not be reimbursed

    • Non-reimbursed individual biomarkers

      • SIPA1L1: Signal-induced proliferation-associated 1 like 1 (SIPA1L1)
      • miRNAs: microRNA (miRNA or miR) analysis, including but not limited to: microRNA-21 (miR-21), miRNA-29a (miR-29a), miRNA-122 (miR-122), miRNA-221 (miR-221), miRNA-222 (miR-222)
      • CHI3L1: Chitinase 3-like 1 (CHI3L1)
      • Hyaluronic acid
      • PCIII: Type III procollagen (PCIII)
      • Type IV collagen
      • Laminin
      • CK-18: Plasma caspase-generated cytokeratin-18
      • MFAP4: Micro-fibrillar associated glycoprotein 4 (MFAP4)
    • Affected codes: 81599
    • Affected codes: 84999
    • Affected codes: 0002M
    • Affected codes: 0003M
    • Affected codes: 0166U
    • Affected codes: 0344U
    • Affected codes: 0468U
    • Potential denial risk for other/unlisted codes representing non-covered assays
    Documentation Required

    Document clinical rationale and prior liver stiffness

    Maintain documentation that supports the covered indication for testing to support reimbursement. Documentation should show the clinical rationale (diagnosis or reason) and, when applicable, prior elevated liver stiffness measurement if testing is to rule out cACLD.

    • Examples of acceptable documentation: diagnosis of chronic HBV or HCV
    • Diagnosis of MASLD/MASH
    • Diagnosis of alcoholic hepatitis
    • Prior elevated liver stiffness measurement when testing to rule out cACLD