ModifiedCapital BluecrossPolicy MP 2.252

Noninvasive techniques for the evaluation and monitoring of chronic liver disease

Defines medical necessity and investigational status for multianalyte serum assays and noninvasive imaging (e.g., FibroSURE, FibroScan, ARFI) used to evaluate or monitor chronic liver disease for Capital BlueCross products.

Policy Summary

PayerCapital Bluecross

PolicyNoninvasive techniques for the evaluation and monitoring of chronic liver disease

Policy CodePolicy MP 2.252

Change TypeMinor revision: monitoring with transient elastography reclassified investigationalcoding/administrative updates

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionVerify prior authorization and coding requirements with the current policy coding table before submitting claims for FibroSURE, FibroScan, or other multianalyte/noninvasive imaging tests.

SourceLink

POLICY UPDATE CHANGES

Removed list of specific indications for transient elastography: All monitoring is now investigational.

Administrative updates adding and removing specific CPT/PLA codes (e.g., added 0468U effective 07/01/2024; added 0344U effective 10/01/2022; deleted 0014M and added 81517 effective 01/01/2024).

Removed the Benefit Variations Section and updated the Disclaimer.

CoveredFibroSURE (evaluation)

InvestigationalFibroSURE (monitoring)

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Coverage Criteria — Medical Necessity and Investigational Uses

inv-01: Medically necessary — Evaluation

Covered when used for evaluation (diagnostic assessment) of chronic liver disease:

FibroSURE evaluation: Single FibroSURE multianalyte assay may be considered medically necessary for the evaluation of individuals with chronic liver disease.

Supports staging corresponding to Metavir; HCV FibroSURE uses 6 markers plus age/sex to estimate fibrosis and necroinflammatory activity.

FibroScan evaluation: Transient elastography (FibroScan) imaging may be considered medically necessary for the evaluation of individuals with chronic liver disease.2.5-75 kPa

FibroScan provides liver stiffness measurements (2.5–75 kPa) correlated with fibrosis; less accurate with ascites, high BMI, or narrow intercostal margins and does not assess necroinflammatory activity or steatosis.

inv-02: Investigational / Not medically necessary

Not covered / investigational uses:

FibroSURE monitoring: FibroSURE multianalyte assay is considered investigational for monitoring of individuals with chronic liver disease.

Insufficient evidence that monitoring with FibroSURE improves health outcomes.

FibroScan monitoring: Transient elastography (FibroScan) is considered investigational for monitoring patients with chronic liver disease.

Insufficient evidence to support benefit for monitoring; policy history also designates monitoring investigational.

Other multianalyte assays with algorithmic analyses are considered investigational for the evaluation or monitoring of individuals with chronic liver disease.

Proprietary algorithm-based tests (other than FibroSURE/FibroTest) lack sufficient evidence for clinical utility.

Other noninvasive imaging including ARFI or real-time tissue elastography is considered investigational for evaluation or monitoring of chronic liver disease.

Insufficient evidence to determine effects on health outcomes for non-FibroScan radiologic methods.

inv-03: Coverage grouped by technology — summary of determinations by modality

Summary of coverage determinations from the evidence review

FibroSURE (specific multianalyte serum assay): Evidence is sufficient to determine that FibroSURE results provide data sufficiently useful to determine therapy and FibroSURE has been used as an alternative to biopsy in RCTs to establish fibrosis/cirrhosis eligibility.

Supported by systematic reviews of >30 observational studies (>5,000 patients).

Transient Elastography (FibroScan): Evidence is sufficient to determine that FibroScan provides data useful to determine therapy for severe fibrosis or cirrhosis and has been used as an alternative to biopsy in RCTs.2.5-75 kPa

Supported by many systematic reviews (>50 studies, >10,000 patients); limitations include failures in high BMI and variable cutoffs.

Other radiologic elastography methods (MRE, ARFI, real-time tissue elastography): Evidence is insufficient to determine effects on health outcomes; these methods may have similar performance for detecting significant fibrosis or cirrhosis but lack direct evidence of improved health outcomes.

inv-04: Investigational monitoring — policy history summary

Policy history summary

Monitoring Elastography Investigational: All monitoring using transient elastography is considered investigational per the 12/09/2024 minor review.

Policy history also documents administrative code additions and deletions; refer to coding table for effective dates.

The policy lists other noninvasive imaging modalities — including acoustic radiation force impulse (ARFI) imaging (e.g., Acuson S2000) and real-time tissue elastography — as investigational for both evaluation and monitoring of chronic liver disease. The source rationale notes ARFI measures shear wave speed (m/s) using an ultrasound 'push' pulse and can be performed during standard sonographic exams, but the policy classifies these modalities as investigational because evidence is insufficient to establish their effects on health outcomes compared with established options such as FibroScan or FibroSURE.

Use of these non‑FibroScan imaging methods for staging or serial assessment should be expected to be denied or considered not medically necessary under this policy. Documentation that the test is intended for evaluation (diagnostic staging) does not change the investigational status for ARFI and real‑time tissue elastography in the absence of supporting evidence of clinical benefit.

The policy identifies proprietary multianalyte assays with algorithmic analyses other than the single FibroSURE test as investigational and not covered. The coding section explicitly lists PLA/CPT codes (for example, 0468U, 83520, and 83883) under investigational multianalyte assays.

Examples of proprietary, algorithm‑based tests (e.g., FIBROSpect II) are described in the background, but unless the test is the FibroSURE panel, these multianalyte assays are considered investigational for evaluation or monitoring and are subject to denial.

The policy history documents a 12/09/2024 minor review that removed the previously listed specific indications for transient elastography and changed the policy stance so that all monitoring with transient elastography is considered investigational. This administrative change is noted as a material policy modification and affects use of transient elastography for serial monitoring rather than single‑time evaluation.

Proprietary multianalyte assays other than the single FibroSURE test (and specific tests described such as FIBROSpect II) are designated investigational and not medically necessary for either evaluation or monitoring of chronic liver disease. The policy text and background describe these tests as algorithm‑based panels combining serum markers, but the available evidence is judged insufficient to support coverage except for the single FibroSURE assay for diagnostic evaluation.

For noninvasive radiologic methods other than vibration‑controlled transient elastography (FibroScan), the policy concludes that evidence is insufficient to demonstrate improved health outcomes. Systematic reviews of observational studies show that methods such as magnetic resonance elastography, ARFI, and real‑time tissue elastography may have similar test performance for detecting fibrosis or cirrhosis, but variable cutoffs, heterogeneous study designs, and limitations of the reference standard prevent construction of a chain of evidence for clinical utility. Consequently, these other radiologic methods are considered investigational.

The policy history entry dated 12/09/2024 explicitly states that the list of specific indications for transient elastography was removed and that all monitoring with transient elastography is now investigational. Clinicians and billing staff should note that while transient elastography (FibroScan) may remain covered for evaluation, its use for serial monitoring has been reclassified as investigational per this policy history update.

Coding — Procedure and Diagnosis Codes

Covered when medically necessary (FibroSURE and transient elastography)mixedCovered

81596	Procedure Codes listed for FibroSURE testing and transient elastography (FibroScan).
91200	Procedure code listed under covered when medically necessary for FibroSURE testing and transient elastography (FibroScan).
76981	Procedure code listed under covered when medically necessary for FibroSURE testing and transient elastography (FibroScan).
76982	Procedure code listed under covered when medically necessary for FibroSURE testing and transient elastography (FibroScan).
76983	Procedure code listed under covered when medically necessary for FibroSURE testing and transient elastography (FibroScan).
81517	Procedure code listed under covered when medically necessary for FibroSURE testing and transient elastography (FibroScan).

Investigational — multianalyte assays (other than FibroSURE)CPTNot Covered

0468U	Procedure code listed as investigational/not covered for multianalyte assays with algorithmic analyses other than FibroSURE.
83520	Procedure code listed as investigational/not covered for multianalyte assays with algorithmic analyses other than FibroSURE.
83883	Procedure code listed as investigational/not covered for multianalyte assays with algorithmic analyses other than FibroSURE.

Investigational — noninvasive imaging (other than FibroScan)CPTNot Covered

0344U

Procedure code listed as investigational/not covered for noninvasive imaging methods other than FibroScan.

Relevant ICD-10 diagnosis codesICD-10

B18.0	Chronic viral hepatitis B with delta-agent.
B18.1	Chronic viral hepatitis B without delta-agent.
B18.2	Chronic viral hepatitis C.
B18.8	Other chronic viral hepatitis.
K70.0	Alcoholic fatty liver.
K70.2	Alcoholic fibrosis and sclerosis of liver.
K73.0	Chronic persistent hepatitis, not elsewhere classified.
K73.1	Chronic lobular hepatitis, not elsewhere classified.
K73.2	Chronic active hepatitis, not elsewhere classified.
K74.0	Hepatic fibrosis.

1–10 of 22

1/3

Policy history — recently added/removed codesmixed

0468U	PLA/code added (document lists new code 0468U effective 07/01/2024).
0344U	PLA/code added effective 10/01/2022.
0014M	PLA/code deleted (document notes deletion of 0014M).
81517	New code added (document notes added 81517 effective 01/01/2024).

FibroScan score range

FibroScan score range2.5-75 kPa

Measurement unitsKilopascals (kPa)

Clinical correlationHigher kPa values correspond to increased liver stiffness and greater fibrosis

No numeric thresholds present

Numeric thresholds in segmentNo numeric thresholds present in this document segment

ImplicationRefer to individual test descriptions or external guidance for specific cutoffs

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization requirements vary by product. Verify member benefits and obtain prior authorization when required by the member's plan before performing FibroSURE (HCV FibroSURE) testing or transient elastography (FibroScan). Coverage is determined by the member's benefit program and medical necessity.

Check eligibility and prior authorization requirements with Capital Blue Cross Provider Services or Member Services prior to scheduling testing.
Coverage is contingent on the member's benefit plan and medical necessity determinations — a code listed in the coding section does not guarantee coverage.

Documentation Required

Document clinical information to support medical necessity when requesting noninvasive testing. When ordering FibroSURE/FIBROSpect II or transient elastography (FibroScan), include pertinent clinical data such as diagnosis, relevant laboratory results (e.g., ALT, AST, platelet count), prior liver biopsy results if available, viral hepatitis status, imaging findings, and the specific clinical question (evaluation vs monitoring). Monitoring indications for FibroSURE or transient elastography are considered investigational per policy; clearly indicate the intended use.

Background and Rationale

Liver biopsy remains the reference standard for staging fibrosis but has limitations including invasiveness, sampling error, and procedure‑related risks. Noninvasive options—serologic multianalyte assays (for example, FibroSURE) and imaging‑based elastography techniques (for example, transient elastography/FibroScan)—are evaluated as alternatives to biopsy. The policy recognizes that FibroSURE and FibroScan have sufficient evidence to be used for evaluation in specified circumstances, whereas other laboratory panels and non‑FibroScan imaging techniques lack sufficient evidence of clinical utility; monitoring with transient elastography has been designated investigational.

Definitions and Test Examples

Metavir scoring system definition

DefinitionHistologic scoring system commonly used in hepatitis C to stage fibrosis (F0–F4) and grade necroinflammatory activity (A0–A3)

Fibrosis scaleF0 = no fibrosis to F4 = cirrhosis

Activity (necroinflammatory) scaleA0 = no/minimal activity to A3 = severe activity

MASLD / MASH definition

MASLD definitionMetabolic dysfunction‑associated steatotic liver disease (MASLD); formerly termed NAFLD; characterized by hepatic steatosis without significant alcohol use

SpectrumRanges from simple steatosis to metabolic dysfunction‑associated steatohepatitis (MASH), which can progress to fibrosis and cirrhosis

Policy Revision History

2024-12-09minor_reviewLatest

Removed the list of specific indications for transient elastography and reclassified all monitoring with transient elastography as investigational.

Policy Summary

PayerCapital Bluecross

PolicyNoninvasive techniques for the evaluation and monitoring of chronic liver disease

Policy CodePolicy MP 2.252

Change TypeMinor revision: monitoring with transient elastography reclassified investigationalcoding/administrative updates

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionVerify prior authorization and coding requirements with the current policy coding table before submitting claims for FibroSURE, FibroScan, or other multianalyte/noninvasive imaging tests.

SourceLink

On This Page

Billing Rule

Coding and Billing

Procedure codes in the coding section are categorized as covered when medically necessary or investigational/not covered. Identification of a code here does not guarantee payment — submit claims with supporting documentation and the applicable diagnosis. Verify that codes used match the service provided and the date-effective guidelines.

Use the current policy coding table for exact billing requirements and effective dates.
Codes listed as investigational (e.g., multianalyte assays other than FibroSURE; noninvasive imaging other than FibroScan) are not covered and may be denied.

Denial Risk

Investigational Uses — Denial Risk

Investigational uses listed in the policy are subject to denial. Multianalyte assays with algorithmic analyses other than FibroSURE, the use of noninvasive imaging modalities other than FibroScan, and any use of these technologies solely for monitoring are considered investigational and may be denied.

Investigational procedure codes include 0468U, 83520, 83883, 0344U (see coding section for full list).
Transient elastography and multianalyte assays used for monitoring are investigational per policy history and may be denied.

Note

Verify New/Changed Codes

Verify prior authorization and coding when new or changed codes are introduced. Administrative code updates occur periodically; confirm effective dates and whether new codes require prior authorization.

Recent administrative updates added or removed codes (see policy history). Check effective dates before billing.
If a new CPT/HCPCS code is used for a service previously described in this policy, contact Provider Services for guidance on prior authorization and billing.

Transient Elastography (FibroScan) description

MethodUltrasound‑based vibration‑controlled transient elastography (FibroScan) using a mechanical vibrator to generate shear waves tracked by ultrasound

Performance characteristicsRapid, bedside capable, wide score range (2.5–75 kPa), validated in many liver diseases; less accurate with ascites or high BMI

LimitationsDoes not assess necroinflammatory activity or steatosis and is inaccurate during acute hepatitis or exacerbations