CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease

Defines coverage stance for noninvasive tests (serum multianalyte assays and specialized radiologic methods) used to evaluate or monitor chronic liver disease for BCBSRI members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNoninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateAug 1, 2025

Key ActionOrdering physicians must obtain authorizations and laboratories must not obtain authorizations on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5+Named tests listed

50+Studies cited for transient elastography

30+Studies cited for FibroSURE

2Codes not covered

5Covered codes listed

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Coverage Criteria and Policy Stance

Product-specific coverage determinations

Medicare Advantage Plans and Commercial Products coverage stance:

Medicare Advantage - medically necessary: Transient elastography (FibroScan) imaging and a single FibroSURE multianalyte assay may be considered medically necessary for evaluation of individuals with chronic liver disease.

applies to Medicare Advantage Plans and Commercial Products

Not covered / Not medically necessary: Transient elastography (FibroScan) for monitoring, FibroSURE multianalyte assays for monitoring, and other multianalyte assays with algorithmic analyses for evaluation or monitoring are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence of improvement in net health outcome.

applies to Medicare Advantage Plans and Commercial Products

Benefit variability

Benefits may vary between groups and contracts:

Benefit variability: Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary/not covered benefits and coverage determinations.

general advisory to verify member-specific benefits

Coverage summary and distinctions

Coverage stance varies by specific test:

FibroSURE/LiverFASt (FibroSURE as offered): FibroSURE serum panels have evidence from systematic reviews and observational studies and have been used as an alternative to biopsy in randomized controlled trials to establish eligibility for hepatitis C therapy; the evidence is sufficient to demonstrate improvement in net health outcome for those indications.

supported by evidence summary in document

Other multianalyte serum assays (non-FibroSURE/LiverFASt): For multianalyte serum assays other than FibroSURE, evidence is insufficient to determine clinical utility due to variable and inconsistently validated cutoffs, imperfect reference standards, and inability to construct a chain of evidence for clinical validity; therefore benefit has not been established.

document states insufficient evidence

ELF Test and LiverFASt (specific codes): CPT 81517 (ELF Test) and 0166U (LiverFASt) are listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

coding table lists these as not covered

Other multianalyte serum assays (aside from a single FibroSURE assay) are considered not covered / not medically necessary for the evaluation or monitoring of chronic liver disease due to insufficient evidence of clinical validity and inability to demonstrate improved net health outcomes. The policy notes variability in assay cutoffs and lack of validated thresholds, which limits interpretation of performance characteristics and precludes establishing clinical utility for these non‑FibroSURE multianalyte tests.

The policy explicitly lists CPT codes 81517 and 0166U as not covered / not medically necessary for Medicare Advantage Plans and Commercial Products. These codes correspond to the ELF Test (81517) and LiverFASt (0166U) multianalyte assays and should not be submitted for coverage under the referenced products.

This policy excerpt does not identify specific clinical exclusion conditions. It emphasizes that member subscriber agreements or employer agreements determine benefits and supersede the medical policy; providers should verify member‑specific coverage via the provider call center and follow the applicable subscriber or participation agreements.

Use of FibroScan (transient elastography) and FibroSURE specifically for serial monitoring of chronic liver disease is considered not covered / not medically necessary. While a single FibroSURE assay and transient elastography may be considered medically necessary for initial evaluation, the policy states both modalities are not covered when used for ongoing monitoring due to insufficient evidence of benefit.

When billed to Medicare Advantage or Commercial Products, the use of CPT 81517 (ELF Test) and CPT 0166U (LiverFASt) is designated as not medically necessary and not covered under the policy. These specific proprietary multianalyte panels are therefore excluded from coverage for the products referenced.

Services determined to be not medically necessary or otherwise non‑covered are governed by the member’s subscriber agreement and employer agreement; providers may not bill the member for such services unless the member has provided prior written agreement to accept financial responsibility. The policy also states that laboratories must not obtain prior authorization on behalf of the ordering physician and that unauthorized laboratory services may be denied as the laboratory’s financial liability.

CPT/HCPCS/ICD-10 Codes and Test Thresholds

Named proprietary serum assay CPT/PLA codesmixed

81596	HCV FibroSURE / FibroTest
81517	Enhanced Liver Fibrosis (ELF) Test
0002M	ASH FibroSURE
0003M	NASH FibroSURE
0166U	LiverFASt

Covered HCPCS (example for ASH FibroSURE)HCPCSCovered

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)

Covered HCPCS (example for NASH FibroSURE)HCPCSCovered

0003M

Covered CPT / Proprietary multianalyte panelsCPTCovered

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

Covered Elastography / Imaging CPT codesCPTCovered

76981	Ultrasound, Elastography; Parenchyma (eg Organ)
91200	Liver elastography, mechanically induced shear wave (eg, vibration), without imaging, with interpretation and report

Not covered / Not medically necessarymixedNot Covered

81517	Liver 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 (ELF Test)
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 (LiverFASt)

Affected codes (not specified in this excerpt)mixed

affected codes

Placeholder reference in this document chunk indicating prior authorization/coverage may affect specific codes; specific CPT/HCPCS codes not listed in these chunks.

ELF test risk cutoffs — numeric cutoffs for risk categories

ELF test lower-risk cutoff<9.80

ELF test higher-risk cutoff≥ 11.30

Intended interpretationManufacturer recommends cutoffs to stratify risk of development of cirrhosis or liver-related events in NASH

Test cutoffs and thresholds — cutoffs exist but variably applied/validated

Existence of cutoffsVarious proprietary and study-specific cutoffs are reported for FibroSURE/LiverFASt and other assays

Provider Responsibilities, Billing, and Authorization

Prior Authorization

Prior Authorization — Ordering Physician Responsibility

Prior authorization for services described in this policy is the responsibility of the ordering physician. Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in authorization, appeal, or other administrative processes related to prior authorization/medical necessity. If a laboratory or third party supports any portion of the authorization process or obtains authorization on behalf of the ordering physician, BCBSRI will deem the action a violation of this policy and may take severe action up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied and financial liability will be assigned to the participating laboratory; such services may not be billed to the member.

Ordering physician must obtain prior authorization when required by member benefits or prior authorization rules.
Laboratories, their representatives, or third parties may NOT obtain authorizations or participate in the authorization/appeal process on behalf of the ordering physician.
Unauthorized lab services will be denied and billed to the provider (not the member).

Background and Rationale

Liver biopsy remains the historical reference standard for staging fibrosis and grading necroinflammatory activity, but it has recognized limitations including invasiveness, small sample size, and subjective interpretation. Noninvasive alternatives such as transient elastography and multianalyte serum assays are described as being investigated as alternatives to biopsy, but interpretation is limited by the imperfect reference standard and variable performance across tests.

Definitions and Test Descriptions

Fibrosis staging — Metavir and La5nec scoring systems (0-4 scales)

Inflammation gradingMost scoring schemes grade inflammation from 0 to 4 (0 = no or minimal; 4 = severe)

Biopsy limitationsBiopsy samples are small and subject to sampling error; fibrosis can be patchy and missed on biopsy

Transient elastography and multianalyte assays — brief definitions

Transient elastography (TE)Ultrasound-based method (FibroScan) measuring shear wave speed to estimate liver stiffness; correlates with fibrosis but limited in ascites/high BMI

Multianalyte serum assaysProprietary panels combine multiple serum biomarkers via algorithms to generate scores categorizing fibrosis or activity

Clinical roleUsed as noninvasive alternatives to biopsy for assessing fibrosis and eligibility for therapy in some trials

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNoninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateAug 1, 2025

Key ActionOrdering physicians must obtain authorizations and laboratories must not obtain authorizations on behalf of the ordering physician.

SourceLink

On This Page

Covered codes and diagnoses: HCPCS 0002M and 0003M, CPT 81596, and elastography codes 76981 and 91200 are listed as covered when billed with ICD-10 diagnosis codes K70.0–K77 or R94.5.

document coding section

Variable applicationCutoffs were not consistently used in validation studies and have been modified over time

Population-specific thresholdsSome thresholds are specific to patient populations and may differ from manufacturer or guideline recommendations

No numerical thresholds present in this excerpt

Numerical thresholds absentNo numerical diagnostic or staging thresholds are provided in this policy excerpt for imaging modalities or many multianalyte assays

Evidence referencesReferences and meta-analyses are cited for elastography and MRI techniques, but without specific numeric cutoffs in this excerpt

ImplicationClinical interpretation requires reference to original studies or manufacturer guidance for numeric thresholds

Billing Rule

Covered CPT/HCPCS Codes and Diagnosis Linkage

BCBSRI covers specific CPT/HCPCS procedures only when billed with the associated ICD-10 diagnosis codes listed in this policy. Claims must include the appropriate diagnosis linkage to support medical necessity and coverage.

Covered when billed with ICD-10 codes K70.0–K77 or R94.5.
Covered CPT/HCPCS codes include: 0002M, 0003M, 81596, 76981, 91200 (see policy code table).
Claims should include the listed CPT/HCPCS codes and the associated ICD-10 diagnosis codes to demonstrate medical necessity.

Note

Prior Authorization and Benefit Verification

Providers must verify member-specific benefits and any prior authorization requirements before rendering services. BCBSRI reserves the right to revise this policy; the member's subscriber agreement and employer agreement govern benefits and eligibility and supersede policy. For member-specific benefit information or to confirm prior authorization requirements, contact the BCBSRI provider call center.

Check member benefits and prior authorization requirements through the provider call center or BCBSRI portals.
Subscriber/member certificate and employer agreement supersede this policy for benefit determination.
BCBSRI may review and revise this policy at any time; always verify current requirements before providing services.

Denial Risk

Use of CPT Codes 81517 and 0166U (Not Covered / Not Medically Necessary)

The following CPT codes are designated as not covered / not medically necessary under this policy and may result in denial if billed: 81517 (Enhanced Liver Fibrosis [ELF] Test) and 0166U (LiverFASt). Providers should not bill members for services denied as not medically necessary unless the member was informed in advance and agreed in writing to be financially responsible.

81517 — Liver disease, analysis of 3 biomarkers (ELF Test) — Not covered / Not medically necessary (effective 2024-01-01).
0166U — LiverFASt (10 biochemical assays with biometric/demographic data) — Not covered / Not medically necessary.
If services are denied as not medically necessary or non-covered, financial liability may fall to the provider or laboratory; providers may only charge members if informed and written consent obtained in advance.

Documentation Required

Coding and Diagnosis Linkage — Claim Submission Requirements

Ensure coding on claims includes the appropriate CPT/HCPCS codes together with the listed ICD-10 diagnosis codes (K70.0–K77, R94.5). Claims missing the required diagnosis linkage or containing codes designated as not covered may be denied or subject to financial liability for the provider.

Include both the procedure code and the supporting ICD-10 diagnosis on all claims.
Codes listed as covered require the matching diagnosis codes K70.0–K77 or R94.5 to be accepted.
Codes listed as not covered (e.g., 81517, 0166U) should not be billed when seeking coverage under BCBSRI; doing so may result in denial.

LiverFASt / FibroSURE — blood-based diagnostic combining 10 biomarkers and algorithm

Test compositionCombines 10 serum biomarkers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, ALT, AST, fasting glucose, triglyceride, total cholesterol) with an algorithm

Commercial offeringOffered exclusively by Fibronostics as LIVERFASt/FibroSURE panels

Clinical evidence noteFibroSURE panels have systematic review evidence (>30 observational studies) supporting use as alternative to biopsy for determining fibrosis/cirrhosis in some contexts

ELF Test (Enhanced Liver Fibrosis) — three biomarkers (HA, PIIINP, TIMP-1) reported as risk score

Biomarkers measuredHyaluronic acid (HA), Procollagen III amino terminal peptide (PIIINP), Tissue inhibitor of metalloproteinase-1 (TIMP-1)

OutputProprietary algorithm produces an ELF risk score reported to predict risk of cirrhosis or liver-related events

Coding noteCPT 81517 is assigned to ELF and is listed as not covered/not medically necessary in this policy excerpt

Transient elastography (TE) — ultrasound-based elastography referenced in multiple meta-analyses

TechniqueUltrasound-based elastography that measures shear wave speed to estimate liver stiffness (FibroScan)

Evidence baseMultiple systematic reviews and >50 observational studies cited supporting TE accuracy for fibrosis staging

LimitationsLess accurate in ascites, high BMI, or narrow intercostal margins; failures may be underreported in validation studies

Magnetic resonance elastography (MRE) — MRI-based elastography with pooled accuracy data

ModalityMagnetic resonance elastography (MRE) is an MRI-based elastography technique to assess liver stiffness and stage fibrosis

Diagnostic performanceSystematic reviews and individual participant pooled analyses cited demonstrating diagnostic accuracy for staging fibrosis, including in NAFLD

Comparative roleIncluded among imaging modalities compared to ultrasound-based methods and serum tests in meta-analyses

Multiparametric MRI — techniques quantifying fibrosis, inflammation, steatosis (e.g., cT1, PDFF)

DefinitionMultiparametric MRI includes quantitative techniques (eg, cT1, PDFF) to measure fibrosis, inflammation, and steatosis

Clinical utilityReferenced for diagnosis, prognosis, and monitoring response to therapy in multiple studies and cohorts

Evidence examplesSeveral observational studies and trials cited showing prognostic and monitoring value of cT1 and related metrics

Acoustic Radiation Force Impulse (ARFI) elastography — ultrasound elastography modality with meta-analysis evidence

ModalityAcoustic Radiation Force Impulse (ARFI) elastography is an ultrasound elastography technique for noninvasive hepatic fibrosis evaluation

EvidenceSystematic reviews and meta-analyses are cited demonstrating diagnostic accuracy of ARFI across viral and nonviral liver diseases

Use caseIncluded among elastography modalities evaluated for staging fibrosis in meta-analyses referenced in this policy