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®) - This technique transmits an elastic shear wave that propagates within the liver. The speed of the shear wave (the harder the tissue, the faster the shear propagates) is measured and quantified to determine the stage of fibrosis.
Acoustic radiation force impulses (ARFI) (e.g., Acuson S2000™) - Permits evaluation of liver stiffness in a smaller region.
Real-time tissue elastography (e.g., HI VISION Preirus™) - Ultrasound able to display real-time elastography images.
Magnetic resonance elastography - Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.

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™)
- Real-time tissue elastography (e.g., HI VISION Preirus™)
- Multiparametric MRI (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:
- - Nonalcoholic fatty liver disease, and hepatic fibrosis or cirrhosis is known or suspected
  - Chronic liver disease excluding 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
- No moderate or severe hepatic iron overload documented (e.g., hemochromatosis, hemosiderosis)

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 to support the use of noninvasive radiologic methods other than transient and magnetic resonance elastography for liver fibrosis measurement is limited. The evidence is insufficient to determine the effects of the technology on health outcomes.

SOURCES

American Association for the Study of Liver Disease / Infectious Disease Society of America. (2021, October).Recommendations for testing, managing, and treating hepatitis C. Retrieved July 21, 2022 from http://www.hcvguidelines.org.

American Association for the Study of Liver Disease. (2018). The diagnosis and management of nonalcoholic fatty liver disease: practice guideline from the American Association for the Study of Liver Disease. Retrieved March 17, 2021 from https://www.aasld.org/publications/practice-guidelines.

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. (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. (12:2023) Noninvasive techniques for the evaluation and monitoring of patients with chronic liver disease. (2.04.41). Retrieved February 14, 2024 from www.bcbsaoca.com/eps/. (100 articles and/or guidelines reviewed)

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)

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.

Winifred S. Hayes, Inc. 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)

Winifred S. Hayes, Inc. 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)

Winifred S. Hayes, Inc. 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)

Winifred S. Hayes, Inc. 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)

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: 3/14/2024

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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