Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease
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This policy governs medical coverage and criteria for noninvasive serum multianalyte assays and specialized radiologic methods used to evaluate and monitor liver fibrosis in individuals with chronic liver disease for BCBSRI members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Policy Statements
Coverage statements
Coverage stance for Medicare Advantage and Commercial Products
Medicare Advantage coverage stance
Medicare Advantage coverage stance
Commercial Products monitoring stance
Commercial Products stance on other proprietary assays
Covered: FibroSURE panels
Covered when used to assess fibrosis/steatosis in chronic liver disease and billed with appropriate diagnosis codes
FibroSURE panels have sufficient evidence to determine clinical utility in certain settings and are listed as covered codes
Not covered / Insufficient evidence
Not covered / insufficient evidence
Not covered / not medically necessary codes
Some genetic testing services may be excluded from coverage for certain self‑funded employer groups that have specifically opted out of the expanded biomarker testing coverage under the state mandate (R.I.G.L. §27‑1981). For plan‑specific determinations, refer to the Genetic Testing Services or Proprietary Laboratory Analyses coding sections and the member's Benefit Booklet or employer agreement to confirm whether a particular genetic test is a contract exclusion.
The following proprietary assay CPT/CPT‑like codes are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 81517 (ELF test), 0166U (LiverFASt), and 0344U (OWLiver). These codes are identified in the policy as lacking sufficient evidence to demonstrate an improvement in net health outcome for the covered populations.
Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement, which supersede this medical policy. Providers should verify member‑specific coverage and call the provider call center when necessary to confirm benefits or prior authorization requirements before rendering services.
For Commercial Products, FibroSURE multianalyte assays and transient elastography (FibroScan) when used for routine monitoring of chronic liver disease are considered not covered / not medically necessary because current evidence is insufficient to show improved net health outcomes for monitoring indications.
Use of CPT/CPT‑like codes 81517, 0166U, and 0344U is considered not medically necessary for Commercial Products and those codes are listed as not covered for Medicare Advantage Plans.
Services that are determined to be not medically necessary or that are non‑covered benefits under a member's plan may not be paid and generally may not be charged to the member unless the member was informed in advance and provided written agreement to accept financial responsibility. Providers should verify coverage and prior authorization requirements for each member before billing.
CPT / HCPCS / Billing Codes
| 81596 | HCV FibroSURE / FibroTest |
| 81517 | Enhanced Liver Fibrosis (ELF) Test |
| 0002M | ASH FibroSURE |
| 0003M | NASH FibroSURE |
| 0166U | LiverFASt |
| 0344U | OWLiver |
| 0002M | Liver 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) |
| 0003M | Liver 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) |
| 81596 | Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver |
| 76981 | Ultrasound, elastography; parenchyma (eg, organ) |
| 91200 | Liver elastography, mechanically induced shear wave (eg, vibration), without imaging, with interpretation and report |
| 81517 | Liver disease, analysis of 3 biomarkers (HA, PIIINP, TIMP-1) ... prognostic algorithm reported as a risk score |
| 0166U | Liver disease, 10 biochemical assays (a2-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 |
| 0344U | Hepatology (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 |
Provider Responsibilities, Billing & Authorization Guidance
Prior authorization applicability
Prior authorization is not applicable for this policy. However, if a laboratory service is performed without proper authorization where authorization was required, the service may be denied and billed to the laboratory rather than the member.
Prior authorization guidance
This policy section does not list specific prior authorization code requirements; providers should consult the full policy or contact the provider call center for any member‑specific prior authorization requirements.
Step therapy
No step therapy requirements are specified in this portion of the policy.
Authorization participant restriction
Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity; laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.
- Laboratory representatives or third parties must not obtain authorization or participate in appeals on behalf of the ordering physician.
- If a laboratory or third party supports any portion of the authorization process, BCBSRI may treat it as a violation up to provider network termination.
Unauthorized laboratory billing will be denied
If a laboratory provides a laboratory service that has not been authorized where authorization is required, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.
- Denial and financial responsibility rest with the performing laboratory when authorization was not obtained.
Required diagnosis coding on claims
Claims should include an appropriate ICD‑10 diagnosis from K70.0 through K77 or R94.5 when billing covered CPT/CPT‑like codes for FibroSURE panels.
- Required ICD‑10 codes: K70.0–K77 or R94.5
Verify member benefits and eligibility
For member‑specific benefits and coverage determination, providers must refer to the member's subscriber agreement, member certificate, or employer agreement and may call the provider call center for information.
- Benefits and eligibility are determined by the member's subscriber agreement or employer agreement and supersede this medical policy.
Prohibited third‑party authorization assistance
Use of a laboratory representative or any third party to obtain prior authorization or to support appeals on behalf of the ordering physician is prohibited and may result in severe action up to termination from the BCBSRI provider network.
- Do not allow laboratory staff or third parties to facilitate authorization or appeal documentation.
Member financial responsibility when services not covered
If services are determined to be not medically necessary (or are non‑covered benefits), providers may not charge the member for those services unless the member was informed and provided written agreement to pay in advance.
- Refer to participation agreements for applicable provisions before billing members for noncovered services.
Clinical Background and Rationale
Liver biopsy remains the criterion standard for staging hepatic fibrosis, but it is invasive and subject to sampling error and interobserver variability. Noninvasive alternatives discussed in this policy include multianalyte serum assays (for example, FibroSURE panels, ELF, OWLiver, LiverFASt) and radiologic elastography techniques such as transient elastography (FibroScan) and MR elastography. These noninvasive methods can estimate liver fibrosis and in some contexts may serve as alternatives to biopsy, but each has limitations—transient elastography performance is reduced in patients with ascites or high body mass index, and serum biomarker panels vary in sensitivity and specificity depending on thresholds and population prevalence.
Definitions and Test Descriptions
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