Serum Testing for Hepatic Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease
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Defines medical necessity and coverage for serum-based tests and multianalyte panels used to assess hepatic fibrosis and necroinflammatory activity in chronic liver disease for Blue Cross NC members and providers.
Updated the name of NAFLD in coverage criteria 1 to MASLD and clarified that multianalyte assays with algorithmic analysis (eg, FibroTest/FibroSure, ELF) are considered medically necessary for chronic liver disease secondary to hepatitis B or C or MASLD.
Added CPT code 0468U to the Billing/Coding section effective 7/1/24.
Updated nomenclature in coverage criteria replacing NAFLD with MASLD and expanded covered indications to include MASLD, MASH, alcoholic hepatitis, and ruling out compensated advanced chronic liver disease (cACLD) for elevated liver stiffness measurement, with testing frequency specified as once every six months.
ELF testing was added to the list of tests explicitly mentioned; subsequently ELF testing was added to Not Covered criteria.
Billing/coding updates: removal of codes 0014M (12/31/23) and 88341/88342 (removed 12/10/25); additions of codes 81517 (effective 1/1/24), 0344U (9/30/22), 0468U (7/1/24), and earlier added 0166U.
Coverage Criteria — When Tests Are Medically Necessary
Medically necessary uses (multianalyte assays)
Covered when ALL of the following are met for multianalyte assays:
Applies to multianalyte assays with algorithmic analysis and is allowed once every six months.
Medically necessary uses (chronic HBV/HCV)
Covered when ALL of the following are met for chronic viral hepatitis:
Specifies FibroSURE variants and ELF/FibroTest as covered for chronic viral hepatitis.
Coverage criteria aligned with guideline pathways
Covered when following guideline-recommended sequencing and use for risk stratification and monitoring:
Supported by AGA, AASLD guidance and WHO recommendations for initial triage; preferred first step in staged algorithms.
Supported by AASLD/AGA statements and cost-benefit analyses demonstrating staged testing improves detection and reduces unnecessary referrals.
EASL, AGA, and AASLD recommend serial monitoring and surveillance actions; follow-up intervals depend on guideline recommendations and clinical context.
Medical necessity and monitoring criteria
Covered when used according to guideline-endorsed scenarios and policy criteria (see policy statement — not fully present in this excerpt).
Policy nomenclature updated from NAFLD to MASLD (12/17/24).
Surveillance interval references from EASL and NICE guidance.
When Covered: Multianalyte assays for MASLD/MASH, alcoholic hepatitis, or cACLD evaluation
Covered when ALL of the following are met
Testing frequency specified as once every six months in policy updates (12/10/25).
When Covered: Chronic HBV or HCV
Covered when ALL of the following are met
Added as a distinct coverage criterion in policy update 12/10/25.
Reimbursement for FibroTest®/FibroSURE® and ELF™ is not allowed when used for diagnosis or evaluation of hepatic fibrosis outside the specific covered indications listed in this policy. The policy explicitly states these tests are not reimbursable for other purposes and are not allowed to monitor patients with chronic liver disease.
Performance of FibroTest is limited in some populations: a meta-analysis in NAFLD reported mean AUC ~0.77 with modest sensitivity (0.72) and specificity (0.69), and the policy notes that FibroTest can underperform in certain cohorts (for example, patients with type 2 diabetes), reducing its utility and increasing false positives that may prompt additional invasive testing.
Noninvasive tests (biomarker panels and elastography) have higher negative predictive value for excluding advanced fibrosis but are less accurate for confirming advanced fibrosis or cirrhosis; the policy indicates that identification of advanced fibrosis or cirrhosis by serum biomarkers/scores and/or elastography often requires confirmation by liver biopsy depending on clinical context.
Except when they are components of a covered multianalyte assay, the policy does not cover use of individual serum biomarkers or certain proprietary multianalyte assays for diagnosis, prognosis, or monitoring of chronic liver disease. The policy lists specific biomarkers (e.g., SIPA1L1, multiple miRNAs, CHI3L1, hyaluronic acid, PCIII, type IV collagen, laminin, CK‑18, MFAP4) as not covered when used alone.
Per the 12/10/25 implementation update, ELF™ (ELFTM) was added to the Not Covered criteria in the Not Covered lists; the update clarifies ELF is included among tests excluded from coverage in certain Not Covered criteria unless used as a component of a covered multianalyte assay.
The policy states that use of listed individual serum biomarkers and some multianalyte assays (examples given in the Not Covered section such as ASH FibroSURE®, LIVERFASt™, NASH FibroSURE®, OWLiver®) is considered investigational and not covered for noninvasive assessment of hepatic steatosis or fibrosis, except when those biomarkers are components of a covered assay.
Available evidence does not support any single serum biomarker or multimarker score as a reliable replacement for liver biopsy to diagnose both NASH and clinically significant fibrosis. A multicenter analysis found that none of 17 biomarkers or multimarker scores reached the predefined AUC ≥0.80 threshold for simultaneously diagnosing NASH and clinically significant fibrosis.
Current guideline statements note that noninvasive tests are not validated for the diagnosis of NASH and therefore should not be used alone to make that diagnosis; the policy reflects these limitations and advises against sole reliance on NITs for NASH diagnosis.
The 12/10/25 policy update explicitly lists ELF™ among tests referenced in the Not Covered criteria; the implementation notes indicate ELF was added to the Not Covered lists and that the Not Covered section was revised to clarify exclusions for specific biomarkers and assays.
Billing, Codes, and Test Thresholds
| 0014M | previously listed; removed effective 12/31/23 |
| 0166U | added to Billing/Coding sections (date not specified in these chunks) |
| 0344U | added to Billing/Coding section 9/30/22 |
| 0468U | added to Billing/Coding section, effective 7/1/24 |
| 81517 | added effective 1/1/24 |
| 88341 | removed from Billing/Coding section 12/10/25 |
| 88342 | removed from Billing/Coding section 12/10/25 |
Provider Responsibilities, Authorization, and Documentation
Prior authorization / frequency for covered multianalyte assays
Use of multianalyte assays with algorithmic analysis (e.g., FibroTest/FibroSURE/ELF) is considered medically necessary for specified indications and is allowed once every six months when used to determine therapy for MASLD (including MASH), alcoholic hepatitis, or to rule out cACLD in individuals with an elevated liver stiffness measurement; for chronic HBV/HCV, FibroSURE, ELF, or FibroTest testing once every six months is medically necessary.
- Frequency: once every six months for covered multianalyte assays per policy statement.
Prior authorization considerations for serial serum fibrosis testing
Guidelines support periodic assessment with noninvasive tests; ELF and other NITs are referenced for serial testing intervals (NICE: offer ELF every 3 years in adults) and society statements note serial longitudinal monitoring can inform management.
- NICE: ELF may be offered every 3 years in adults (every 2 years in children/young people).
- AGA/AASLD: serial longitudinal monitoring using NITs may inform clinical management.
Applicable service codes — potential prior authorization/review
The policy lists applicable service codes that may be used for these tests; inclusion in the billing/coding section does not guarantee reimbursement and claims remain subject to medical necessity review.
Authorization and eligibility note
This medical policy is informational and is not an authorization; benefits and eligibility for services are determined by the member's group contract and subscriber certificate in effect at the time of service.
- BCBSNC may require medical records to determine medical necessity.
Implied staged testing supported by evidence
Evidence and economic analyses support staged testing algorithms using simple serum indices followed by second-line NITs to improve detection and reduce unnecessary referrals.
- Cost-benefit modeling example: FIB-4 for all followed by ELF or FibroScan for indeterminate results increased detection of advanced fibrosis and reduced unnecessary referrals.
Stepwise testing — FIB-4 first, then ELF or elastography for indeterminate results
A stepwise approach is supported: perform a simple serum index (e.g., FIB-4) first and, if results are indeterminate or suggest fibrosis, proceed to ELF or elastography (transient elastography) as second‑line testing.
- AGA: FIB-4 <1.3 has strong NPV to exclude advanced fibrosis; if FIB-4 >1.3 or indeterminate, use additional NITs (ELF, elastography) for staging.
- Staged testing (FIB-4 then ELF or FibroScan) was modeled to increase detection and reduce referrals.
Applicable service codes / provider action note
Applicable service codes are listed in the policy billing section for reference, but inclusion does not ensure coverage; verify coding history and current applicability before submission.
Billing/coding history — verify prior to submission
Review billing and coding history when implementing tests; policy implementation notes record prior code additions and removals that may affect claim submission.
Benefits verification
Verify benefits in the Member's Benefit Booklet to confirm availability of coverage for the services described in this policy prior to ordering tests.
- Member benefits may vary by design; review benefit language before applying the policy.
Routine labs every six months for patients with cirrhosis
For patients with cirrhosis, perform routine laboratory monitoring (basic metabolic panel, liver function tests, CBC, PT/INR) every six months to recalculate Child‑Pugh and MELD scores as part of standard management.
- AASLD and AAFP guidance include routine labs and using NITs or elastography for evaluation of advanced fibrosis per recommendations.
Records required for medical necessity review
BCBSNC may request medical records for medical necessity review; letters of support alone are often insufficient unless they include all specific information required for the determination.
- When records are requested, include all clinical details that support the medical necessity of the test; letters can supplement but not replace records.
Medical records and documentation guidance
Letters of support/explanation may be useful but are not sufficient by themselves for medical necessity determinations unless they contain all specific required clinical information.
- Provide full medical records and documentation of clinical context when requested.
Triggers for denial — out-of-scope use of named assays/biomarkers
Claims will be denied when FibroTest/FibroSURE or ELF are used for diagnosis or evaluation of hepatic fibrosis outside the policy's specified covered indications; reimbursement is also not allowed for the listed serum biomarkers when used alone.
- Policy not covered: FibroTest/FibroSURE/ELF reimbursement is not allowed in circumstances other than the listed covered indications.
- Specific serum biomarkers (e.g., miRNAs, hyaluronic acid, PCIII, MFAP4) are not covered when used alone.
Use guideline-recommended NITs and thresholds or risk coverage impact
Use APRI, FIB-4, or elastography with guideline-recommended thresholds for fibrosis assessment and follow guideline-recommended sequencing; failure to follow recommended sequencing (e.g., not using FIB-4 first) may affect coverage decisions.
- WHO thresholds: APRI >0.5 or FibroScan >7.0 kPa for ≥F2; APRI >1.0 or FibroScan >12.5 kPa for cirrhosis (F4).
- AGA recommends FIB-4 <1.3 to exclude advanced fibrosis and using a second NIT if FIB-4 is >1.3 or indeterminate.
Documentation and medical necessity review may be requested
Inclusion of procedure or billing codes in the policy does not guarantee reimbursement; BCBSNC may request medical records to determine medical necessity for submitted claims.
- Verify medical necessity documentation and be prepared to provide records if requested.
Medical record documentation may be required — risk of denial if insufficient
BCBSNC may request medical records to determine medical necessity; failure to include required specific information in records or reliance on letters alone can lead to denial.
- Provide complete records including clinical history, relevant labs, imaging, and rationale for testing to support medical necessity.
Background and Rationale
Chronic liver disease encompasses chronic hepatitis, progressive hepatic fibrosis, cirrhosis, and hepatocellular carcinoma. Hepatic fibrosis results from extracellular matrix deposition and degradation in response to chronic liver injury; although liver biopsy is the diagnostic gold standard, serum biomarkers and multianalyte panels provide noninvasive assessment alternatives but have limitations in accuracy and clinical application.
Definitions and Test Descriptions
Policy Revision History and Change Log
New policy developed; BCBSNC will provide coverage for serum testing for hepatic fibrosis when medically necessary and criteria are met.
CPT code 0344U added to the Billing/Coding section.
Code 0014M removed effective 2023-12-31 and code 81517 added effective 2024-01-01.
Code 0468U added to the Billing/Coding section effective 2024-07-01 (recorded 2024-07-17).
Updated nomenclature in coverage criteria replacing NAFLD with MASLD and clarified multianalyte assays (e.g., FibroTest/FibroSURE/ELF) are medically necessary for chronic liver disease secondary to hepatitis B, C, or MASLD.
Comprehensive update: removed codes 88341 and 88342 from Billing/Coding; expanded When Covered to include MASLD (including MASH), alcoholic hepatitis, and ruling out cACLD with testing frequency specified as once every six months; ELF testing was added to Not Covered criteria.
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