CurrentPremera BluecrossPolicy PA-101

Noninvasive Tests for Hepatic Fibrosis

Defines medical necessity, investigational indications, and coding for noninvasive blood and imaging tests used to detect or monitor liver fibrosis in individuals with chronic liver disease; applies to Premera members covered under Individual Plans.

Policy Summary

PayerPremera Bluecross

PolicyNoninvasive Tests for Hepatic Fibrosis

Policy CodePolicy PA-101

Change TypeMinor review — no material change

Effective DateApr 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization when required and document clinical indication and timing relative to prior biopsy or elastography.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ELF, FibroTest, FibroSure, TE, MRENamed noninvasive tests addressed

6 codesCodes listed

Multiple markers & ARFIInvestigational examples

Individual PlansPlan applicability

Coverage Criteria for Noninvasive Hepatic Fibrosis Tests

FibroTest/FibroSure and ELF — Medical Necessity

Covered when ALL of the following are met

Indications: Test is ordered for detection or prognosis of liver fibrosis in persons with chronic liver diseases such as: chronic hepatitis C; chronic hepatitis B carriers; metabolic conditions including nonalcoholic fatty liver disease (NAFLD); individuals who consume excess alcohol; HIV co-infection; or to provide access to new-generation non-interferon hepatitis treatments.

From policy coverage criteria (FibroTest/FibroSure and ELF).

Test types: Enhanced Liver Fibrosis (ELF) Test or FibroTest/FibroSure (FT/ActiTest/HCV FibroSure) is the serum biomarker panel ordered.

ELF measures HA, PIIINP, TIMP-1; FibroTest measures A2M, apolipoprotein A1, haptoglobin, GGT, total bilirubin (definitions).

Frequency limitation: Performance of FibroTest/FibroSure more than twice per year or within 6 months following a liver biopsy or transient elastography is considered not medically necessary.

Policy Summary

PayerPremera Bluecross

PolicyNoninvasive Tests for Hepatic Fibrosis

Policy CodePolicy PA-101

Change TypeMinor review — no material change

Effective DateApr 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization when required and document clinical indication and timing relative to prior biopsy or elastography.

SourceLink

On This Page

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Transient Elastography (TE) — Medical Necessity

Covered when ALL of the following are met

Indications: Transient elastography (TE) is used to distinguish hepatic cirrhosis from non-cirrhosis and for initial assessment or detection/monitoring of hepatic fibrosis in persons with hepatitis C or other chronic liver diseases (including NAFLD).

Policy states TE (e.g., FibroScan) medically necessary for these indications.

Device considerations: TE (e.g., FibroScan) is an ultrasound-based elastography modality; limitations (e.g., ascites, high BMI, severe steatosis) may affect test performance and should be considered when ordering and interpreting results.

Operational note: document factors that may limit TE accuracy.

Exclusions for TE: Use of TE for other indications (for example, prediction of ascites in persons with chronic liver disease) is not supported by the policy and considered outside the listed medical necessity indications.

Policy specifies acceptable TE indications and excludes other applications.

Magnetic Resonance Elastography (MRE) — Medical Necessity

Covered when ALL of the following are met

Indications: Magnetic resonance elastography (MRE) is ordered when metabolic dysfunction-associated steatohepatitis (MASH) and hepatic fibrosis or cirrhosis is known or suspected.

Policy: MRE may be considered medically necessary for MASH and suspected hepatic fibrosis/cirrhosis.

Role of MRE: MRE is used as an MRI-based elastography technique to assess and stage hepatic fibrosis when less-invasive tests are inconclusive or when MASH is suspected.

Operational note: document prior noninvasive test results and clinical indication for MRE.

Investigational / Not Covered Indications

The following are considered investigational for detection or monitoring of hepatic fibrosis and thus not medically necessary

Investigational tests: Acoustic Radiation Force Impulse (ARFI); Hepatic Artery Resistive Index; serum marker tests including Angiotensin converting enzyme, FibroMAX, FibroSpect, HepaScore, LIVERFAST, micro-fibrillar associated glycoprotein 4 (MFAP4); microRNAs including miR-21, miR-29a, miR-122, miR-221, miR-222; NASH FibroSure; plasma cytokeratin-18.

Policy provides a non–all-inclusive list of investigational tests considered not medically necessary for detection/monitoring of hepatic fibrosis.

Coverage for FibroTest/FibroSure and related serum biomarker panels is limited to the specific chronic liver disease indications listed in the policy. These tests are covered when ordered for evaluation or prognosis of hepatic fibrosis in individuals with chronic hepatitis C; carriers of chronic hepatitis B; metabolic liver disease such as nonalcoholic fatty liver disease (NAFLD); persons who consume excess alcohol; HIV co-infection; or to provide access to new-generation non‑interferon hepatitis treatments. FibroTest/FibroSure is considered investigational for all other indications.

Performance frequency is restricted: FibroTest/FibroSure performed more than twice per year or within 6 months following a liver biopsy or transient elastography (TE) is not medically necessary and may be denied. When interpretation of results may be affected by coexisting conditions (for example, chronic hemolysis, Gilbert disease, presence of a cardiac valvular prosthesis, or certain HIV protease inhibitors that alter bilirubin or enzyme levels), consultation with a liver disease specialist is advised.

The policy lists multiple serum biomarker panels and noninvasive imaging elastography techniques that are considered investigational (not medically necessary) for detection or monitoring of hepatic fibrosis. Examples provided include acoustic radiation force impulse (ARFI), hepatic artery resistive index, and a range of serum marker tests such as FibroMAX, FibroSpect, HepaScore, LIVERFAST, MFAP4, NASH FibroSure, and plasma cytokeratin-18.

Additionally, multiple microRNA assays are listed as investigational, for example miR-21, miR-29a, miR-122, miR-221, and miR-222. This list is not exhaustive; any of these tests used for detection or monitoring of hepatic fibrosis in chronic liver disease are considered investigational under the policy.

Procedure and Biomarker Codes

Listed procedure and biomarker CPT codesCPT

76981	Ultrasound, elastography; parenchyma organ
76982	Ultrasound, elastography; first target lesion
76983	Ultrasound, elastography; each additional target lesion (List separately in addition to code for primary procedure)
81517	Liver disease, analysis of 3 biomarkers (hyaluronic acid [HA], procollagen III amino terminal peptide [PIIINP], tissue inhibitor of metalloproteinase [TIMP-1]), using immunoassays, utilizing serum, prognostic algorithm reported as risk score and risk of liver fibrosis and liver-related clinical events within 5 years
81596	Infectious disease; chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin)
91200	Liver elastography, mechanically induced shear wave vibration), without imaging, with interpretation and report

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for Procedure and Biomarker CPT Codes

Prior authorization may be required for the procedures and biomarker panels listed below. Submit prior authorization requests with clinical documentation supporting the indication and timing (see documentation callout).

CPT 76981 – Ultrasound elastography (parenchyma)
CPT 76982 – Ultrasound elastography; first target lesion
CPT 76983 – Ultrasound elastography; each additional target lesion
CPT 81517 – ELF (hyaluronic acid, PIIINP, TIMP-1)
CPT 81596 – HCV panel (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin)
CPT 91200 – FibroTest / FibroSure-type panel

Note

Step Therapy

No step therapy requirements are specified for these tests in this policy. Clinicians should follow standard prior authorization and documentation requirements as applicable.

Documentation Required

Clinical Indication and Timing Documentation

Document the clinical indication and timing for testing in the medical record and include this information with any prior authorization request. Acceptable indications include but are not limited to:

Evaluation of hepatic fibrosis in chronic hepatitis C
Diagnosis of fibrosis in chronic hepatitis B carriers
Evaluation of fibrosis in metabolic conditions (NAFLD/MASH)
Assessment in patients with excess alcohol use
Evaluation in HIV co-infected individuals
When needed to provide access to specific antiviral treatment decisions

Timing expectations: document date of prior relevant liver biopsy or transient elastography; tests performed more than twice per year or within 6 months following a liver biopsy or transient elastography are generally considered not medically necessary. If clinical context could alter test components (eg, chronic hemolysis, Gilbert syndrome, protease inhibitor use such as indinavir or atazanavir, or medications affecting GGT/ALT like ritonavir), include specialist (hepatology) interpretation or consult note.

Acceptable clinical indications: hepatitis C, chronic hepatitis B, NAFLD/MASH, excess alcohol use, HIV co-infection, treatment access decisions
Include dates of prior liver biopsy or transient elastography when applicable
Tests >2 times/year or within 6 months post-biopsy/TE are usually not medically necessary
Note conditions that may affect test components (chronic hemolysis, Gilbert disease, certain HIV protease inhibitors) and include hepatology input if present

Denial Risk

Frequency Limitations and Denial Risk for FibroTest / FibroSure

Performance of FibroTest/FibroSure more than twice in a 12-month period, or within 6 months following a liver biopsy or transient elastography, is considered not medically necessary and may be denied without supporting documentation demonstrating medical necessity. Provide documentation when repeat testing is requested within these intervals explaining the clinical rationale.

Not medically necessary: FibroTest/FibroSure >2 times per year
Not medically necessary: FibroTest/FibroSure within 6 months after liver biopsy or transient elastography
If repeat testing is requested within these timeframes, include detailed clinical justification and prior procedure dates

Definitions of Tests and Panels

Transient elastography (TE)

DefinitionUltrasound-based elastography (eg, FibroScan) that measures liver stiffness to distinguish cirrhosis from non‑cirrhosis and assess fibrosis stage

Primary purposeNoninvasive assessment of hepatic fibrosis and to differentiate cirrhosis (METAVIR F4) from lower fibrosis stages

LimitationsAccuracy reduced in presence of ascites, moderate–severe steatosis, fluid overload (eg, chronic kidney disease), or acute conditions that increase stiffness (eg, sickle cell crisis)

Typical outputLiver stiffness measurement used with scoring systems (eg, METAVIR fibrosis stages F0–F4)

Enhanced Liver Fibrosis (ELF) Test

Panel componentsHyaluronic acid (HA); N‑terminal propeptide of type III procollagen (PIIINP); tissue inhibitor of metalloproteinase‑1 (TIMP‑1)

CPT code81517 — analysis of 3 biomarkers (HA, PIIINP, TIMP‑1) with prognostic algorithm reported as risk score and 5‑year risk of liver fibrosis/events

PurposeSerum panel of direct fibrosis markers used to assess and prognosticate hepatic fibrosis severity

FibroTest / FibroSure

Panel componentsAlpha‑2‑macroglobulin (A2M); apolipoprotein A1; haptoglobin; gamma‑glutamyltransferase (GGT); total bilirubin

Reported outputsPrognostic algorithm reporting scores for fibrosis and necroinflammatory activity (commercially known as FibroTest/FibroSure)

Related CPT codes81596 — 6‑assay panel for chronic HCV (ALT, A2M, apolipoprotein A‑1, total bilirubin, GGT, haptoglobin); 91200 — algorithm reported as fibrosis and necroinflammatory activity scores (FibroTest/FibroSure description)

Magnetic Resonance Elastography (MRE)

DefinitionMRI‑based elastography technique that measures liver stiffness using mechanically induced shear waves

Medical necessityMay be considered medically necessary when metabolic dysfunction‑associated steatohepatitis (MASH) and hepatic fibrosis or cirrhosis is known or suspected

Use caseAlternative noninvasive imaging to assess fibrosis severity when clinical suspicion for MASH/fibrosis/cirrhosis exists

OpenPayer

Noninvasive Tests for Hepatic Fibrosis

Coverage Criteria for Noninvasive Hepatic Fibrosis Tests

Procedure and Biomarker Codes

Provider Requirements, Prior Authorization, and Documentation

Background and Rationale

Definitions of Tests and Panels

Revision History