DESCRIPTION
Noninvasive techniques to diagnose and monitor liver fibrosis are being investigated as alternatives to liver biopsy in individuals with chronic liver disease. Options for noninvasive monitoring consist of multianalyte serum assays with algorithmic analysis and specialized radiologic methods including magnetic resonance elastography, transient elastography, acoustic radiation for impulse imaging and real-time transient elastography.
Noninvasive imaging is proposed as an alternative to liver biopsy to diagnose and evaluate the degree of fibrosis by mapping the elastic properties of soft tissue. Imaging techniques currently being investigated include:
Transient Elastography (FibroScan®) - Also known as vibration-controlled transient elastography (VCTE), this technique uses a mechanical vibrator to generate low-frequency (50Hz), mild-amplitude shear waves that propagate through the liver. Shear-wave velocity, which increases the tissue stiffness, is measured and quantified to estimate the degree of liver fibrosis. Other transient elastography techniques include:
Hepatus®, which combines visualized transient elastography (ViTE) with a conventional ultrasound to quantify liver stiffness (kPa) and steatosis using LiSA (an ultrasound attenuation metric) and provides real-time two-dimensional image guidance.
Acoustic radiation force impulses (ARFI) (e.g., Acuson S2000™ Virtual Touch, Acuson S3000™ Virtual Touch, Acuson Sequoia, Acuson Maple, Canon Aplio series Shear Wave Elastography, GE LOGIQ pSWE / SWE, Philips ElastQ Imaging, Philips ElastPQ, EPIQ 7, Samsung S-Shearwave™, Siemens Virtual Touch™, Siemens Virtual Touch™ IQ, SuperSonic® Imagine Aixplorer® and Aixplorer® Ultimate Ultrasound Systems, SuperSonic® MACH®/MACH 20/MACH 30/MACH 40, SuperSonic® HepaVu™) - ARFI imaging uses an ultrasound probe to produce an acoustic “push” pulse, which generates shear waves that propagate in tissue to assess liver stiffness. Permits evaluation within a localized region. There are two main categories:
Qualitative ARFI - The tissue is pushed by a focused ultrasound pulse and the localized displacement is imaged. This provides a visual contrast between soft (brighter) and stiff (darker) tissues. There is no numerical stiffness value.
Quantitative ARFI - Measures the speed of shear waves generated by the ARFI push pulse. Since shear waves travel faster in stiffer tissue, velocity can be converted to stiffness.
Point shear wave elastography (pSWE) - generates a shear wave and measures its speed at one location.
Two-dimensional shear wave elastography (2D-SWE) - pushes tissue repeatedly to generate shear waves across a region, creating a full elastography map.
Real-time tissue elastography (e.g., HI VISION Preirus™) - Ultrasound able to display real-time elastography images.
Magnetic resonance elastography (MRE) (e.g., Resoundant, QED SureWave™ Elastography, Canon MR Elastoplasty) - Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.
Multiparametric magnetic resonance imaging (MMRI) (e.g. LiverMultiScan) - Combines an assessment of hepatic fat content that can be used to determine steatosis grading with T1 and T2 mapping to evaluate liver tissue characteristics. T1 relaxation times reflect increases in extracellular fluid associated with the fibrosis and inflammation, while T2 relaxation times are used to asses hepatic iron content.
Note: This policy does not address multianalyte serum assays, standard imaging with ultrasound, or MRI.
POLICY
Transient elastography imaging (i.e., FibroScan®) when used to evaluate and/or monitor individuals with chronic liver disease is considered medically necessary.
Magnetic resonance elastography is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transient elastography imaging (i.e., FibroScan®) when used to evaluate and/or monitor individuals with focal liver disease is considered investigational.
All other noninvasive imaging that maps the elastic properties of soft tissue to evaluate and/or monitor individuals with chronic liver disease are considered investigational. These technologies include, but are not limited to, the following:
Acoustic radiation force impulse imaging (e.g., Acuson S2000™, et al)
Real-time tissue elastography (e.g., HI VISION Preirus™)
Multiparametric MRI (e.g., LiverMultiScan)
MEDICAL APPROPRIATENESS
Magnetic resonance elastography is considered medically appropriate if ALL of the following are met:
Chronic liver disease, as indicated by ANY ONE of the following:
Metabolic dysfunction-associated steatotic liver disease (formerly nonalcoholic fatty liver disease), and hepatic fibrosis or cirrhosis is known or suspected
Chronic liver disease excluding metabolic dysfunction-associated steatotic liver disease (formerly nonalcoholic fatty liver disease) (e.g., chronic hepatitis C virus infection, chronic hepatitis B virus infection) and need to assess for advanced fibrosis or cirrhosis with ANY ONE of the following:
BMI of 30 or greater
Vibration-controlled transient elastography is unavailable, contraindicated, or results are indeterminate
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The evidence base is limited for noninvasive radiologic methods of liver fibrosis measurement beyond transient elastography and magnetic resonance elastography. Furthermore, evidence is insufficient to support alternative transient elastography techniques, such as ViTE (e.g., Hepatus®) or MAP (e.g., Liverscan C]) at this time. The clinical impact of these technologies on health outcomes has not been established.
Expert consensus guidelines have recommended standardized thresholds for classification of fibrosis based on magnetic resonance elastography-based stiffness measurements. Individuals with severe hepatic iron overload (e.g., due to hemochromatosis) may require the use of alternative image acquisition techniques to overcome lower signal intensity of the shear wave displacement.
SOURCES
American Association for the Study of Liver Diseases. (2023). AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Retrieved May 12, 2025 from https://www.aasld.org/publications/practice-guidelines.
American Association for the Study of Liver Diseases. (2024). AASLD practice guideline on imaging-based noninvasive liver disease assessment of hepatic fibrosis and steatosis. Retrieved March 11, 2026 from https://www.aasld.org/practice-guidelines.
American Association for the Study of Liver Diseases / Infectious Disease Society of America. (2023, May). Hepatitis c guidance 2023 update: recommendations for testing, managing, and treating hepatitis C virus infection. Retrieved May 12, 2025 from https://www.idsociety.org/practice-guideline/hcv-guidance/.
American College of Radiology. (2019). ACR appropriateness criteria, Chronic liver disease. Retrieved March 9, 2021 from https://www.acr.org/Clinical-Resources/ACR-Appropriateness-Criteria.
American Gastroenterological Association. (2022). American Gastroenterological Association clinical practice update: diagnosis and management of nonalcoholic fatty liver disease in lean individuals: expert review. Retrieved April 1, 2026 from https://gastro.org/clinical-guidance/.
American Gastroenterological Association. (2017). American Gastroenterological Association Institute guideline on the role of elastography in the evaluation of liver fibrosis. Retrieved March 9, 2021 from https://gastro.org/guidelines/liver-diseases/.
BlueCross BlueShield Association. Evidence Positioning System. (11:2025) Noninvasive techniques for the evaluation and monitoring of patients with chronic liver disease. (2.04.41). Retrieved March 11, 2026 from www.bcbsaoca.com/eps/. (126 articles and/or guidelines reviewed)
Duarte-Rojo, A., Taouli, B., Leung, D. H., Levine, D., Nayfeh, T., et al. (2025). Imaging-based noninvasive liver disease assessment for staging liver fibrosis in chronic liver disease: A systematic review supporting the AASLD Practice Guideline. Hepatology, 81 (2), 725-748. (Level 1 evidence)
European Association for the Study of the Liver. (2021). European Association for the Study of the Liver clinical practice guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. Retrieved from https://easl.eu/publications/clincal-practice-guidelines/.
Harris, R., Harman, D., Card, T., Aithal, G., & Guha, I. (2017). Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review. The Lancet: Gastroenterology & Hepatology, 2 (4), 288-297. Abstract retrieved July 18, 2017 from PubMed database
Hashemi, S., Alavian, S., Gholami-Fesharaki, M. (2016). Assessment of transient elastography (FibroScan) for diagnosis of fibrosis in non-alcoholic fatty liver disease: a systematic review and meta-analysis. Caspian Journal of Internal Medicine, 7 (4), 242-252. (Level 1 evidence)
Hayes, a symplr company. Health Technical Assessment. (2019, April; last update search April 2022). Acoustic radiation force impulse (ARFI) elastography for detecting hepatic fibrosis in patients with hepatitis C. Retrieved July 20, 2022 from www.Hayesinc.com/subscribers. (84 articles and/or guidelines reviewed)
Hayes, a symplr company. Health Technology Assessment. (2023, February; last updated search March 2026). LiverMultiScan (Perspectum) for diagnosis of liver fibrosis and steatosis related to nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Retrieved March 11, 2026 from www.Hayesinc.com/subscribers. (44 articles and/or guidelines reviewed)
Hayes, a symplr company. Health Technology Assessment. (2020, April; last update search May 2023). Magnetic resonance elastography for prognosis of liver disease progression. Retrieved February 14, 2024 from www.Hayesinc.com/subscribers. (58 articles and/or guidelines reviewed)
Hayes, a symplr company. Health Technology Assessment. (2020, June; last update search June 2023). Magnetic resonance elastography for detecting and staging liver fibrosis. Retrieved February 14, 2024 from www.Hayesinc.com/subscribers. (97 articles and/or guidelines reviewed)
Hayes, a symplr company. Medical Technology Directory. (2020, July; last update search March 2022). Ultrasound transient elastography for detecting hepatic fibrosis in patients with hepatitis C. Retrieved July 20, 2022 from www.Hayesinc.com/subscribers. (80 articles and/or guidelines reviewed)
Lam, S., Nettel-Aguirre, A., Van Biervliet, S., Roeb, E., Sadler, M., Friedrich-Rust, M., et al. (2019). Transient elastography in the evaluation of cystic fibrosis-associated liver disease: systematic review and meta-analysis. Journal of the Canadian Association of Gastroenterology, 2 (2), 71-80. (Level 2 evidence)
Li, Y., Huang, Y., Wang, Z., Yang, Z, Sun, F., Zhan, S. (2016). Systematic review with meta-analysis: the diagnostic accuracy of transient elastography for the staging of liver fibrosis in patients with chronic hepatitis B. Alimentary Pharmacology and Therapeutics, 43 (4), 458-469. (Level 1 evidence)
Lin, Y., Li, H., Jin, C., Wang, H., & Jiang, B. (2020). The diagnostic accuracy of liver fibrosis in non-viral liver diseases using acoustic radiation force impulse elastography: A systematic review and meta-analysis. PloS One, 15 (1), e0227358. (Level 1 evidence)
National Institute for Health and Care Excellence. (2017). Hepatitis B (chronic): diagnosis and management. Retrieved August 6, 2018 from www.nice.uk/guidance.
Roulot, D., Roudot-Thoraval, F., NKontchou, G., Kouacou, N., Costes, J., Elourimi, G., et al. (2017). Concomitant screening for liver fibrosis and steatosis in French type 2 diabetic patients using Fibroscan. Liver International, 37 (12), 1897-1906. Abstract retrieved July 18, 2017 from PubMed database.
Shen, Y., Wu, S.D., Wu, L., Wang, S.Q., Chen, Y., Liu, L.L., et al. (2019). The prognostic role of liver stiffness in patients with chronic liver disease: a systematic review and dose-response meta-analysis. Hepatology International, 13 (5), 560-572. Abstract retrieved July 19, 2019 from PubMed database.
Singh, S., Venkatesh, S.K., Wang, Z., Miller, F.H., Motosugi, U., Low, R.N., et al. (2015). Diagnostic performance of magnetic resonance elastography in staging liver fibrosis: a systematic review and meta-analysis of individual participant data. Clinical Gastroenterology and Hepatology,13 (3), 440-451.e6. (Level 2 evidence)
U.S. Food and Drug Administration. (2013, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K123806 (FibroScan®). Retrieved July 18, 2017 from https://www.accessdata.fda.gov.
Xiao, H., Shi, M., Xie, Y., & Chi, X. (2017). Comparison of diagnostic accuracy of magnetic resonance elastography and Fibroscan for detecting liver fibrosis in chronic hepatitis B patients: A systematic review and meta-analysis. PLoS ONE, 12 (11), e0186660. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 11/12/2016
MOST RECENT REVIEW DATE: 7/31/2026
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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