Artificial Liver Assist Devices for the Treatment of Liver Conditions
DESCRIPTION
Artificial liver assist devices, for the treatment of liver conditions, are intended as support therapy or treatment option, for individuals with liver failure caused by illness, alcohol, poisons or drugs. The device is intended to remove toxins from the blood stream.
The devices and therapies under investigation vary. The biological liver support therapies utilize hepatocytes or whole organs derived from animal or human sources. The non-biological approaches are based on dialysis, filtration, and adsorption techniques. The procedure can be referred to as liver dialysis.
POLICY
Artificial liver assist devices for the treatment of liver conditions are considered investigational.
IMPORTANT REMINDER
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, or 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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies in peer-reviewed journals that support the efficacy of these devices or the effect on health outcomes are not available.
SOURCES
American Association for the Study of Liver Diseases (AASLD). (2005, May). AASLD position paper: The management of acute liver failure. Retrieved June 1, 2009 from http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/acute%20liver%20failure.pdf.
Bachli, E. B., Schuepbach, R. A., Maggiorini, M., Stocker, R., Mullhaupt, B., & Renner, E. L. (2007). Artificial liver support with the molecular adsorbent recirculating system: Activation of coagulation and bleeding complications. Liver International, 27 (4), 475-484. Abstract retrieved July 9, 2007 from PubMed.
Bansal, B., & Dhawan, A. (2006). Acute liver failure. Indian Journal of Pediatrics, 73 (10), 931-934.
Koffron, A., & Stein, J. A. (2008). (2008). Liver transplantation: Indications, pretransplant evaluation, surgery, and posttransplant complications. Medical Clinics of North America, 92 (4) 861-888.
Munoz, S. J. (2008). The hepatorenal syndrome. Medical Clinics of North America, 92 (4) 813-837.
Munoz, S. J. (2008). Hepatic encephalopathy. Medical Clinics of North America, 92 (4) 795-812.
Park, J. K. & Lee, D. H. (2005). Bioartificial liver systems: Current status and future perspective. Journal of Bioscience and Bioengineering, 99 (4), 311-319.
Stadibauer, V., & Jalan, R. (2007). Acute liver failure: Liver support therapies. Current Opinion in Critical Care, 13 (2), 215-221. Abstract retrieved July 9, 2007 from PubMed database.
Sussman, N. L., McGuire, B. M. & Kelly, J. H. (2009). Hepatic assist devices: Will they ever be successful? Current Gastrolenterology Reports, 11 (1), 64-68. Abstract retrieved January 25, 2011 from PubMed database.
U. S. Food and Drug Administration. (1999, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K992196. Retrieved May 29, 2009 from http://www.fda.gov/cdrh/pdf/k992196.pdf.
ORIGINAL EFFECTIVE DATE: 9/1/2002
MOST RECENT REVIEW DATE: 3/10/2011
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.
This document has been classified as public information.