CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

This policy governs coverage and medical necessity determinations for transient elastography (FibroScan) imaging to evaluate and monitor fibrosis in patients with chronic liver disease for BlueCHiP Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTransient elastography (FibroScan) for chronic liver disease (evaluation covered; monitoring not covered for some products)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 2, 2020

Next Review DateN/A

Key ActionWhen covered, submit procedure codes 76981 or 91200 with an applicable diagnosis code in the range K70.0–K77 or R94.5.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

02/01/2020policy dates shown

2 codesprocedure codes covered

K70.0-K77covered diagnosis range

20+references cited

Coverage Criteria and Limitations

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Coverage stance and clinical limitations

Covered when criteria below are met by product and clinical indication

Product-specific coverage: Transient elastography (FibroScan) imaging may be considered medically necessary for the evaluation of patients with chronic liver disease for BlueCHiP for Medicare and Commercial Products.

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Not covered/Not medically necessary for monitoring: Transient elastography (FibroScan) imaging is considered not covered for BlueCHiP for Medicare and not medically necessary for Commercial products for monitoring of patients with chronic liver disease.

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Clinical limitations: FibroScan does not assess necroinflammatory activity or steatosis and is less accurate during acute hepatitis or hepatitis exacerbations; performance is reduced in ascites, high body mass index, or narrow intercostal margins.

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Transient elastography (FibroScan) measures liver stiffness by generating shear waves and tracking them with ultrasound, which correlates with fibrosis but has known diagnostic limits. Importantly, FibroScan does not provide information on necroinflammatory activity or steatosis, and it is less accurate during acute hepatitis or hepatitis exacerbations. Performance is also reduced in patients with ascites, high body mass index, or narrow intercostal margins.

Providers must not bill members for services determined to be not medically necessary or otherwise non-covered unless the member has been informed and has given written consent in advance to receive and pay for the service. Verify member-specific benefits and any required agreement language through the provider call center or the member's subscriber/employer agreement before obtaining such consent.

Use of transient elastography for routine monitoring of patients with chronic liver disease is explicitly limited: it is not covered for BlueCHiP for Medicare and is considered not medically necessary for Commercial products when used for monitoring. As with all services, this policy is informational and does not guarantee payment; providers should verify benefits and authorization requirements with the provider call center prior to performing testing.

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization / Coverage Distinctions

Prior authorization is not required for transient elastography (FibroScan). Coverage and clinical applicability vary by product and indication: FibroScan is considered medically necessary for evaluation of chronic liver disease but is not covered for BlueCHiP for Medicare and is not medically necessary for Commercial products when used for monitoring of chronic liver disease.

Prior authorization: Not applicable
Coverage distinction: FibroScan is covered for evaluation of chronic liver disease; not covered for BlueCHiP for Medicare and not medically necessary for Commercial when used for monitoring

Note

Verify Coverage / Authorization

Verify member benefits and prior authorization requirements before scheduling. Coverage is determined by the member's subscriber agreement or employer contract; contact the provider call center for member-specific determinations.

Contact provider call center to verify benefits and authorization requirements for the specific member

Billing Rule

Billing Guidance

Submit claims with the applicable procedure code and a supported diagnosis code from the list below when the service is covered.

When covered, submit CPT 76981 or CPT 91200 with diagnosis code in K70.0–K77 or R94.5

Documentation Required

Member Financial Consent Requirement

Providers may not bill a member for services determined to be non-covered or not medically necessary unless the member provided written informed consent in advance to accept financial responsibility.

Obtain written informed consent before charging a member for non-covered or not medically necessary services

Note

Provider Action

Provider action: follow clinical indications in policy for evaluation (not for routine monitoring). Transient elastography is medically necessary for evaluation of chronic liver disease; do not use for routine monitoring in Commercial or BlueCHiP for Medicare where policy lists it as not covered/not medically necessary.

Use FibroScan for diagnostic evaluation per policy criteria; avoid for monitoring when policy deems it not medically necessary/not covered

Background and Rationale

Liver biopsy has historically been the criterion standard for staging hepatic fibrosis, but it is invasive and samples only a small portion of the liver. Transient elastography (FibroScan) offers a noninvasive alternative by using a mechanical vibrator to create shear waves and ultrasound to measure liver stiffness, which correlates with fibrosis stage. While FibroScan can provide clinically useful data to identify severe fibrosis or cirrhosis and has been used as an alternative to biopsy in trials, its sampling and performance limitations must be considered when interpreting results.

Key Terms and Definitions

inv-16: FibroScan — transient elastography definition

TermFibroScan (transient elastography)

DefinitionUses a mechanical vibrator to generate low-frequency (50 Hz) waves that create an elastic shear wave through the liver; ultrasound tracks wave speed (reported in kilopascals) as a measure of liver stiffness.

Clinical correlationIncreased liver stiffness measured by FibroScan correlates with greater fibrosis and can be used to assess for severe fibrosis or cirrhosis.

LimitationsDoes not provide information on necroinflammatory activity or steatosis; less accurate during acute hepatitis or exacerbations; performs poorly in ascites, high BMI, or narrow intercostal margins.

inv-17: Metavir score — staging F0–F4 (F4 = cirrhosis)

TermMetavir score

DefinitionHistologic scoring system used to grade liver fibrosis from F0 to F4 and necroinflammatory activity (A0–A3).

F4 meaningF4 indicates cirrhosis — presence of fibrous septa subdividing liver parenchyma into nodules, representing final irreversible disease.

Clinical useMost commonly used in hepatitis C to stage fibrosis; stage of fibrosis is the single most important predictor of morbidity and mortality in HCV patients.

inv-18: Elastography — general definition including ARFI methods

TermElastography (general)

DefinitionNoninvasive imaging techniques that assess liver fibrosis by measuring tissue stiffness using mechanical shear waves tracked by ultrasound-based methods.

ARFI methodsAcoustic Radiation Force Impulse (ARFI) elastography is an ultrasound-based technique that uses short-duration acoustic pulses to generate shear waves and estimate liver stiffness; studied in systematic reviews and meta-analyses for diagnostic accuracy.

Clinical roleUsed to stage fibrosis and estimate cirrhosis risk across chronic liver disease etiologies; evidence includes multiple meta-analyses and guideline reviews supporting diagnostic performance for fibrosis staging.