Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease
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Defines coverage and medical necessity for noninvasive laboratory and imaging tests used to evaluate or monitor liver fibrosis in individuals with chronic liver disease for BCBSRI Medicare Advantage and commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria — Noninvasive Evaluation and Monitoring of Chronic Liver Disease
Medicare Advantage Plans and Commercial Products coverage statements
Coverage stance differs by test and by use (evaluation vs monitoring):
Applies to evaluation (initial staging).
Applies to evaluation (initial staging).
Monitoring use is not covered due to insufficient evidence.
Monitoring use is not covered.
Insufficient evidence to determine improvement in net health outcome.
FibroSURE (HCV) — coverage rationale
Covered when used to assess fibrosis/cirrhosis to determine therapy eligibility in HCV and certain chronic liver disease contexts
Support from >30 observational studies (>5000 patients) cited
Other multianalyte serum assays (ELF, OWLiver, LiverFASt) — coverage stance
Not covered / insufficient evidence for routine clinical use
AASLD noted conflicting data; further comparative studies in larger, diverse populations are needed.
Some genetic testing services may be excluded from coverage for certain self-funded commercial groups under contract. Refer to the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses (PLA) policies for lists of tests that require prior authorization, are not medically necessary, or are contract exclusions. For member-specific determinations, consult the member's Benefit Booklet or employer/subscriber agreement, which supersede this medical policy.
The following proprietary multianalyte assay CPT/PLA codes are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 81517 (Enhanced Liver Fibrosis/ELF test), 0166U (LiverFASt), and 0344U (OWLiver). Exact code descriptors are provided in the Coding section.
Benefits and eligibility for laboratory and imaging services are determined by the member's subscriber agreement, member certificate, or employer agreement and may supersede this medical policy. Providers should verify member benefits and eligibility by contacting the provider call center prior to ordering services. No other explicit blanket coverage exclusions are stated in this section beyond those noted by contract or in the Coding sections.
Monitoring and evaluation options addressed in this policy include transient elastography (FibroScan) and proprietary serum multianalyte assays. The policy states that transient elastography (FibroScan) may be considered medically necessary for evaluation (initial staging) but is not covered for monitoring in Medicare Advantage Plans and is not medically necessary for monitoring in Commercial Products. Similarly, FibroSURE is considered medically necessary for evaluation but is listed as not covered / not medically necessary for monitoring. Other multianalyte algorithm-based serum assays are considered not covered/not medically necessary for evaluation or monitoring due to insufficient evidence of benefit.
For Commercial Products the policy considers the ELF (81517), LiverFASt (0166U), and OWLiver (0344U) assays to be not medically necessary. For Medicare Advantage Plans these same assays are listed as not covered. Providers should reference the Coding section for the specific code descriptions and note that use of these codes may result in denial.
Services determined to be not medically necessary by this policy may be non-covered benefits. Providers may not bill the member for such services unless the member has been notified and has provided written agreement to accept financial responsibility in advance. Always confirm member-specific coverage and any required prior authorization with the provider call center.
Coding — CPT / PLA / Test Codes and Test Cutoffs
| 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) using immunoassays, utilizing serum, prognostic algorithm reported as a risk score and risk of liver fibrosis and liver related clinical events within 5 years |
| 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 (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 Actions, Billing, and Authorization Notes
Ordering physician must manage authorization; labs prohibited from obtaining authorization
Prior authorization is listed as Not applicable in the policy header, but the ordering physician is explicitly responsible for any authorization, appeal, or administrative processes; laboratories are prohibited from obtaining authorization or participating in the authorization process on behalf of the ordering physician.
- Ordering physician must handle authorizations and appeals; laboratories may not obtain clinical authorization or participate in authorization on the physician’s behalf.
- If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.
Use CPT/PLA codes listed as covered (0002M, 0003M, 81596; elastography codes)
Coverage is defined by CPT/PLA code. Codes 0002M (ASH FibroSURE), 0003M (NASH FibroSURE), and 81596 (HCV FibroSURE/FibroTest) are listed as covered when used with the indicated ICD-10 diagnoses; listed elastography codes (76981, 91200) are also covered.
No explicit PA code requirements in this section
This section contains no explicit prior authorization code requirements; the policy header states Prior Authorization: Not applicable.
No additional provider action specified
(No additional provider action specified in policy text.)
No step therapy requirements specified
The document specifies no clinical step-therapy requirements for ordering these tests.
No step therapy required
No step therapy requirements are specified in this section of the policy.
Ordering physician must manage authorization and appeals (labs/third parties prohibited)
Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity; laboratories or third parties must not support or perform authorization activities on the physician’s behalf.
- If a laboratory or third party is found to be supporting any portion of the authorization process, BCBSRI may deem it a violation and take severe action up to termination from the provider network.
- Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.
Pair CPT/PLA codes with indicated ICD-10 diagnoses
When ordering covered proprietary serum panels, use the listed CPT/PLA procedure codes and pair them with an appropriate ICD-10 diagnosis (K70.0–K77 or R94.5) as indicated in the coding table.
- Examples: 0002M, 0003M, 81596 should be reported with ICD-10 codes K70.0–K77 or R94.5 per the policy.
- Refer to the coding section for exact code-to-test mappings.
Verify member benefits and eligibility via provider call center
For member-specific benefits and eligibility, providers must contact the BCBSRI provider call center because benefits are determined by the member's subscriber or employer agreement which supersedes this medical policy.
Unauthorized laboratory services will be denied and lab is financially liable
If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.
- Unauthorized services performed by a lab will be denied and the laboratory bears financial responsibility.
Labs/third parties assisting authorization risk network termination
If a laboratory or third party is found to be supporting any portion of the authorization process on behalf of the ordering physician, BCBSRI will deem it a violation and may terminate the provider from the BCBSRI provider network.
- Use of a laboratory representative or third party to obtain or facilitate authorization is prohibited and subject to severe action, up to termination.
Do not charge member for non-covered services without written consent
Services determined to be not medically necessary (or medically necessary but non-covered benefits) may not be charged to the member unless the member has been informed and agreed in writing in advance to proceed at their own expense.
- Obtain written member agreement before charging a member for non-covered services.
Background — Rationale and Clinical Context
Liver biopsy remains the historical reference standard for staging fibrosis but is invasive and samples only a small portion of liver tissue. Noninvasive alternatives described in this policy include proprietary multianalyte serum assays (for example, FibroSURE and other panels) and specialized radiologic methods such as transient elastography (FibroScan) and MR elastography. These noninvasive tests aim to estimate fibrosis stage to guide treatment and monitoring across chronic liver disease etiologies, but evidence for some assays is insufficient to demonstrate improved net health outcome compared with standard approaches.
Definitions — Tests and Terminology
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