Blue Cross Blue Shield RI noninvasive liver testing Coverage

Coverage Determinations

Coverage stance: evaluation vs monitoring; test-specific distinctions

Covered when meeting the following evaluation vs monitoring distinctions:

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

Supported by systematic reviews and used as an alternative to biopsy in trials to establish treatment eligibility; see FibroScan and FibroSURE evidence summaries.

Not covered / Not medically necessary (monitoring): For Medicare Advantage and Commercial Products: FibroSURE multianalyte assays and transient elastography (FibroScan) are considered not covered for monitoring of individuals with chronic liver disease; other multianalyte assays with algorithmic analyses are not covered for evaluation or monitoring due to insufficient evidence.

Policy differentiates initial evaluation (may be covered) from longitudinal monitoring (not covered).

Limitations and operational note: Laboratories are prohibited from obtaining authorization or participating in authorization processes on behalf of the ordering physician; violations may result in denial and provider network sanctions.

Only the ordering physician may be involved in authorization, appeal, or other administrative processes related to medical necessity; unauthorized lab actions may be financially liable.

Code coverage and evidence summary

Code-level coverage and supporting evidence notes:

Covered codes (evaluation): Certain CPT/HCPCS codes for liver elastography and HCV FibroSURE are listed as covered for specified ICD-10 diagnoses; see coding module for code-to-diagnosis linkage.

Policy lists covered CPT codes with required ICD-10 codes for Medicare Advantage and Commercial Products.

Not covered / not medically necessary codes: CPT 81517 (Enhanced Liver Fibrosis [ELF] Test) is listed as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as of 01/01/2024.

New code effective 01/01/2024 is explicitly listed as not covered/not medically necessary in the policy.

Additional proprietary assay codes: Codes for multianalyte 10-biomarker assays (e.g., 0166U, 0002M, 0003M) and HCV FibroSURE (81596) are included in the policy coding sections; evidence summaries in the policy vary by assay.

Policy associates these codes with the named proprietary assays and summarizes the evidence base (systematic reviews, variable cutoffs).

Evidence insufficient for non-FibroSURE assays

Evidence conclusion for multianalyte assessments other than FibroSURE:

Evidence insufficient: For multianalyte serum assays other than FibroSURE, the evidence is insufficient to determine that these technologies improve net health outcomes due to heterogeneous and often nonvalidated cutoffs, population-specific thresholds, and lack of direct evidence linking test results to clinical benefit.

Comparisons favor transient elastography over various serum-based tests for fibrosis detection; absence of a usable chain of evidence precludes coverage for these assays as clinically useful.

The policy distinguishes between use of multianalyte serum assays and algorithmic analyses for initial evaluation versus ongoing monitoring. Evidence for proprietary multianalyte assays other than FibroSURE is heterogeneous: studies have used varying and sometimes unvalidated cutoffs, results may be population-specific, and comparisons indicate transient elastography often performs better for fibrosis detection. Because of these limitations and the lack of direct evidence linking non‑FibroSURE assays to improved health outcomes, the document concludes that such other multianalyte assays with algorithmic analyses are considered not covered / insufficient evidence for evaluation or monitoring of chronic liver disease.

The Enhanced Liver Fibrosis (ELF) Test is assigned CPT code 81517. For Medicare Advantage Plans this code is listed as not covered, and for Commercial Products the ELF test under CPT 81517 is listed as not medically necessary in this policy.

Although single FibroSURE and transient elastography may be considered medically necessary for initial evaluation, the policy explicitly states that both FibroSURE multianalyte assays and transient elastography (FibroScan) are not covered for the purpose of routine monitoring of individuals with chronic liver disease for Medicare Advantage and Commercial Products.

For Commercial Products the policy explicitly lists the Enhanced Liver Fibrosis Test (ELF; CPT 81517) as not medically necessary. The policy notes this is a new CPT code effective 01/01/2024 and replaces prior coding (e.g., 0014M) for dates before 01/01/2024.

Coding and Test Identifiers

Named proprietary tests and assigned CPT/HCPCS codesmixed

81596	HCV FibroSURETM (FibroTest) CPT code
81517	Enhanced Liver Fibrosis (ELF) Test CPT code
0166U	LiverFAStTM CPT code

Covered CPT/Elastography codesCPTCovered

81596	Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver
76981	Ultrasound, Elastography; Parenchyma Organ
91200	Liver elastography, mechanically induced shear wave, without imaging, with interpretation and report

Not covered / not medically necessaryCPTNot Covered

81517

Liver disease, analysis of 3 biomarkers (hyaluronic acid, PIIINP, TIMP-1), immunoassays, utilizing serum, prognostic algorithm reported as risk score (Enhanced Liver Fibrosis Test) — new code effective 2024-01-01

Proprietary 10-biomarker assay codesCPT | HCPCS | mixed

0166U	Liver disease, 10 biochemical assays and biometric/demographic data, algorithm reported as scores for fibrosis, necroinflammatory activity, and steatosis (LiverFASt)
0002M	Liver disease, ten biochemical assays utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH FibroSURE)
0003M	Liver disease, ten biochemical assays utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH FibroSURE)

inv-12: ELF test interpretation cutoffs

ELF test - lower risk cutoff<9.80

ELF test - higher risk cutoff>=11.30

ContextManufacturer-recommended cutoffs relate to risk of cirrhosis or liver-related events in patients with NASH

inv-13: Cutoff thresholds — evidence notes

Variation across studiesCutoff thresholds have frequently varied across studies; some standardized, others modified or not validated

Population specificityThresholds may be specific to certain patient populations and modified over time

Provider Responsibilities & Billing Notices

Prior Authorization

Not applicable.

Prior authorization: Not applicable for this policy.
Only the ordering physician may participate in the authorization, appeal, or other administrative processes related to authorization/medical necessity.
Laboratories and third parties are prohibited from obtaining or participating in authorization on behalf of the ordering physician; such actions may result in severe sanctions including termination from the BCBSRI provider network.

Billing Rule

Coding & Diagnosis Linkage

CPT and ICD-10 coding linkage and coverage status are summarized below. Providers must include an appropriate ICD-10 diagnosis code when billing covered CPT codes; benefits may vary by member subgroup/contract so confirm member benefits prior to providing services.

Clinical Background

Liver biopsy remains the criterion standard for staging fibrosis and assessing necroinflammatory activity because it directly samples hepatic tissue. However, biopsy is invasive, samples a small portion of the liver, and has subjective scoring with associated procedural risks. Noninvasive alternatives discussed in this policy include serum multianalyte algorithmic assays (e.g., FibroSURE, LiverFASt, ELF) and specialized radiologic methods such as transient elastography; each modality has limitations — for example elastography does not assess necroinflammatory activity or steatosis and serum assays have variable cutoffs and limited direct evidence linking test results to improved clinical outcomes.

Key Test Definitions

inv-27: Transient elastography (FibroScan) — description and performance

ModalityUltrasound-based transient elastography (FibroScan) uses a mechanical vibrator to induce a shear wave tracked by ultrasound to measure liver stiffness in kilopascals

Clinical performanceProvides useful data to determine presence of severe fibrosis or cirrhosis and has been used as an alternative in clinical trials to establish treatment eligibility

LimitationsPerformance reduced in ascites, high BMI, and narrow intercostal windows; does not assess necroinflammatory activity or steatosis; failures can be common and may be underreported in validation studies

inv-28: HCV FibroSURE

Test nameHCV FibroSURE (FibroTest) — proprietary serum multianalyte algorithm

Biomarkers and inputs

Policy Revision Timeline

01/01/2024policy_effective

Policy effective date established.

11/06/2024last_reviewLatest

Policy last reviewed.

OpenPayer

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