Serum Testing for Hepatic Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease AHS - G2110
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This policy governs coverage for serum-based biomarker and multianalyte assay testing to evaluate or monitor hepatic fibrosis in individuals with chronic liver disease for Blue Cross Blue Shield - North Carolina members and providers.
Updated nomenclature from NAFLD to MASLD and expanded covered indications to explicitly include metabolic dysfunction-associated steatohepatitis (MASH) and alcoholic hepatitis; clarified testing frequency as once every six months for specified indications.
Specific CPT and other billing code changes were made over time, including additions (e.g., 0344U, 0468U, 81517) and removals (e.g., 0014M, 88341, 88342).
For chronic hepatitis B or C infections, FibroSURE, ELF, or FibroTest testing once every six months is considered medically necessary.
Coverage Criteria and Clinical Indications
Medically necessary uses
Covered when ALL of the following are met for specified assays:
From policy: item 1 in coverage
From policy: item 2 in coverage
Guideline-aligned coverage criteria
Coverage and clinical use supported when testing is consistent with guideline-recommended indications and thresholds
AASLD recommendation to assess advanced fibrosis in HCV
WHO/AASLD/AGA guidance supporting stepwise testing
AGA and AASLD recommendations for NAFLD risk stratification
AASLD and NICE note ELF utility
Guidelines do not endorse routine use of miRNA; evidence cited as investigational
General coverage statement
Covered when determined medically necessary and criteria met (policy states coverage is provided when medical necessity criteria are satisfied).
High-level policy statement; see detailed When Covered criteria for specifics
When Covered
Covered when specified clinical conditions and intervals are met
Policy language updated 12/17/24 and 12/10/25
New coverage criteria added 12/10/25
Reimbursement of FibroTest®/FibroSURE® and ELF™ (ELFTM) is not allowed for diagnosis or evaluation of hepatic fibrosis in circumstances other than the specific, listed medically necessary indications. The policy also states these assays may not be used to monitor patients with chronic liver disease outside the described covered contexts.
A meta-analysis of FibroTest™ in nonalcoholic fatty liver disease (NAFLD) reported a mean AUC of 0.77, mean sensitivity 0.72, and mean specificity 0.69, indicating suboptimal accuracy for detecting significant or advanced fibrosis. The policy notes FibroTest™ therefore does not meet minimally acceptable performance to reliably replace biopsy for these indications, although performance for cirrhosis detection was better (AUC 0.92) and high negative predictive values may be achieved in low-prevalence primary care settings when sensitivity is optimized.
Inclusion of a CPT/HCPCS/other service code in the Billing/Coding section is informational only and does not guarantee reimbursement. BCBSNC may request medical records and apply benefit and contract provisions to determine whether a submitted charge meets medical necessity requirements.
Except when a biomarker is included as a component of one of the covered multianalyte assays (e.g., FibroTest®/FibroSURE® or ELF™), the policy specifies that a list of individual serum biomarkers and certain proprietary panels (e.g., ASH FibroSURE®, LIVERFAStTM, NASH FibroSURE®, OWLiver®) are not covered or are investigational in all situations.
Use of the listed individual serum biomarkers — including miRNA analyses (such as miR-21, miR-29a, miR-122, miR-221, miR-222), CHI3L1, hyaluronic acid, type III procollagen (PCIII), type IV collagen, laminin, plasma caspase‑generated cytokeratin‑18, and MFAP4 — is explicitly not covered for diagnosis, prognosis, or monitoring of chronic liver disease unless they are reported as part of an allowed multianalyte assay.
The policy summarizes systematic reviews showing that no single serum biomarker or multimarker score consistently reached a predefined AUC threshold (0.80) to replace biopsy for diagnosing both NASH and clinically significant fibrosis. While some individual markers (e.g., SomaSignal, ADAPT) or elastography reached acceptable accuracy for advanced fibrosis, routine standalone use of single biomarkers for combined diagnostic indications is not supported by the evidence presented.
Guideline summaries in the policy emphasize that noninvasive tests are less accurate for diagnosing significant fibrosis compared with liver biopsy and that, depending on clinical context, histological confirmation may be required. The document also notes serum biomarkers are better validated in viral hepatitis than in NAFLD and are more reliable for detecting cirrhosis than for identifying significant fibrosis.
The policy states that standalone use of the specified serum biomarkers (not part of an allowed multianalyte assay) for diagnosis, prognosis, or monitoring of chronic liver disease is not covered. ELF™ was added to the Not Covered criteria for standalone testing, and several proprietary multianalyte assays remain investigational and not covered in any situation.
Billing, CPT/HCPCS and Code Lists
| No codes listed |
Provider Requirements, Documentation, and Authorization
Coverage requirements — multianalyte assays allowed every 6 months
Use of multianalyte assays with algorithmic analysis (for example, FibroTest/FibroSURE or ELF) is considered medically necessary for specified indications and is allowed once every six months when criteria are met (MASLD/MASH, alcoholic hepatitis, or to rule out cACLD with elevated liver stiffness; chronic HBV or HCV).
- Allowed frequency: once every six months for covered indications.
- Covered indications: chronic liver disease secondary to MASLD (including MASH), alcoholic hepatitis, ruling out cACLD with elevated LSM; chronic HBV or HCV.
Prior authorization alignment — follow guideline indications
The policy does not state any explicit prior authorization program here; however, when noninvasive tests are used they should align with guideline‑recommended indications, thresholds, and manufacturer specifications (e.g., staging in HCV, risk stratification in NAFLD).
- Align testing use with guideline indications (AASLD, AGA) and apply recommended thresholds when interpreting results.
- Follow manufacturer specifications (e.g., contraindications such as ascites or pacemakers for some NITs).
Coding listed does not guarantee reimbursement; records may be requested
Inclusion of service codes in the Billing/Coding section does not guarantee reimbursement; BCBSNC may request medical records to determine medical necessity and payment.
Medical policy is informational — verify benefits separately
This medical policy is not an authorization; benefits and eligibility are determined by the member’s group contract and subscriber certificate in effect at the time of service.
- Obtain benefit verification prior to testing to confirm coverage under the member’s plan.
Alternative testing context — noninvasive panels and elastography
Policy describes alternative noninvasive tests (APRI, FIB‑4, FibroTest/FibroSURE, HepaScore, transient elastography) as options; some tests (e.g., ELF) may be used as secondary risk assessment when elastography is unavailable.
- Consider APRI or FIB‑4 as simple initial tests; reflex to elastography or proprietary serum tests if indeterminate or high‑risk.
- ELF is an approved prognostic serum test and may be used when elastography is not available.
Suggested stepwise testing — start with FIB‑4/APRI then reflex
Guidelines and modeling support a stepwise approach: use inexpensive, simple tests (FIB‑4 or APRI) for initial triage in primary care with reflex to more advanced testing (ELF, FibroScan) when results are indeterminate or indicate higher risk.
- Use FIB‑4 <1.3 to exclude advanced fibrosis; if >1.3, perform a second NIT (serum or imaging).
- Reflex to elastography or ELF when initial test is indeterminate or suggests advanced disease.
Benefit verification required before applying policy terms
Review member benefit language before applying this medical policy; benefits may vary by plan and the policy applies only to the services described herein.
- Verify coverage and benefits with the member’s plan prior to ordering tests.
Required clinical documentation — routine labs and NIT results
Providers must document routine laboratory tests (ALT, AST, albumin, bilirubin, INR, CBC with platelets) and the results of serum fibrosis marker panels or elastography used to evaluate fibrosis stage, consistent with guideline‑recommended monitoring.
- Include routine blood tests and serum fibrosis marker or elastography results in the medical record.
- For patients with cirrhosis, perform relevant labs every six months per guidelines to recalculate severity scores.
Medical records may be requested — include full clinical details
BCBSNC may request medical records to determine medical necessity; when records are requested include all specific information needed for the determination because letters alone are often insufficient.
- Provide full clinical records, test results, and context when requested; letters of support are insufficient unless they contain all required information.
- Lack of requested information may result in non‑coverage.
Documentation requirements for medical necessity — include all specific information
When medical records are requested for medical necessity review, include all specific information needed for the determination; letters of support alone are not sufficient unless they contain required details.
- Ensure documentation addresses indication, prior test results, clinical findings, and rationale for testing frequency (e.g., once every six months when applicable).
Claims denial triggers — noncovered assays and biomarkers
Reimbursement is not allowed for FibroTest/FibroSURE or ELF except as specified in the covered indications; numerous other multianalyte panels and individual biomarkers are considered investigational or not covered.
- FibroTest/FibroSURE and ELF are not reimbursed outside the specified covered indications and frequency.
- Panels such as ASH FibroSURE, LIVERFASt, NASH FibroSURE, OWLiver, and individual biomarkers (e.g., hyaluronic acid, PCIII, CK‑18, miRNA) are investigational/not covered.
Threshold-based coverage risk — apply NIT thresholds
Tests that do not meet established noninvasive thresholds (for example, APRI or transient elastography thresholds per WHO) may not reliably establish significant fibrosis or cirrhosis and could affect coverage determinations.
- WHO thresholds: APRI >0.5 or transient elastography >7.0 kPa for ≥F2; APRI >1.0 or transient elastography >12.5 kPa for cirrhosis (F4).
- Failure to meet accepted thresholds may necessitate further testing (e.g., biopsy) for staging.
Medical records may be requested — coding inclusion not a guarantee
Inclusion of a code in the Billing/Coding section does not guarantee reimbursement; BCBSNC may request medical records for determination of medical necessity and absence of requested information may result in non‑coverage.
- Be prepared to submit requested medical records when codes are billed.
- Incomplete documentation can lead to denial of coverage.
Medical records may be requested — provide requested details
BCBSNC may request medical records for determination of medical necessity; absence of requested specific information may result in a non‑coverage determination.
- When records are requested, include clinical context, prior test results, and rationale for testing frequency to support medical necessity.
Background and Evidence Summary
Chronic liver disease encompasses a range of conditions including chronic hepatitis, cirrhosis, and hepatocellular carcinoma; hepatic fibrosis results from extracellular matrix deposition that can progress to cirrhosis. Noninvasive assessment of fibrosis employs direct and indirect serum biomarkers and multianalyte panels, but liver biopsy remains the diagnostic gold standard with noninvasive tests serving as adjuncts for risk stratification and triage.
Definitions and Test Descriptions
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