Liver Transplantation
DESCRIPTION
Liver transplantation is performed as a treatment of last resort for individuals with end-stage liver disease. End-stage liver failure manifestations include progressive jaundice, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis, intractable ascites, intractable pruritus, and bleeding diathesis or coagulopathy.
Individuals are prioritized for transplant according to length of time on the waiting list and severity of illness criteria developed by the United Network of Organ Sharing (UNOS). UNOS eliminated the original liver allocation system based on assignment to Status 1, 2A, 2B, or 3 in February of 2002. The new system retains Status 1 and Status 7. Status 1 is intended to describe those individuals with acute liver failure who have a life expectancy of less than seven days. Status 7 describes those individuals who are temporarily inactive due to intercurrent medical problems.
Status 2A, 2B and 3 are now replaced with a new scoring system referred to as MELD (Model for End-stage Liver Disease) for adults and PELD (Pediatric End-stage Liver Disease) for individuals under age 18 years. Status 2A, 2B and 3 were based on the Child-Turcotte-Pugh score, which included a subjective assessment of symptoms as part of the scoring system. MELD and PELD are a continuous disease severity scale based entirely on objective laboratory values. These scales have been found to be highly predictive of the risk of dying from liver disease for individuals waiting on the transplant list. The MELD score incorporates bilirubin, prothrombin time (i.e., INR - International Normalized Ratio) and creatinine into an equation, producing a number that ranges from 1 to 40. The PELD score incorporates albumin, bilirubin, INR growth failure and age at listing.
Aside from Status 1, donor livers are prioritized to those with the highest MELD or PELD number; waiting time is only used to break ties among patients with the same MELD or PELD score and blood type compatibility. In the previous system, waiting time was often a key determinant of liver allocation, and yet waiting time was found to be a poor predictor of the urgency of liver transplant. This was due to some individuals being listed early in the course of their disease, while others were listed only when they became sicker. In the new MELD and PELD allocation system, individuals with higher MELD or PELD scores will always be considered before those with lower scores, even if some individuals with lower scores have waited longer.
POLICY
Liver transplantation (cadaveric or living donor) for the treatment of end-stage liver failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Repeated labs and procedures are medically necessary to address changes in condition and for continued transplant listing.
Multiple labs and work-up procedures are considered not medically necessary for the sole purpose of repeat evaluation at multiple transplant centers.
Liver retransplant for a failed liver transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
See also:
MEDICAL APPROPRIATENESS
Liver transplantation (cadaveric or living donor) for the treatment of end-stage liver failure is considered medically appropriate with ALL the following:
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
ABSENCE of ALL of the following absolute contraindications:
Extrahepatic malignancy including cholangiocarcinoma in the past five years with the exception of basal cell and squamous cell carcinoma of skin
Hepatocellular carcinoma that has extended beyond the liver
Uncontrolled systemic sepsis
Active substance abuse (e.g., alcohol, drugs)
Irreversible advanced cardiac, pulmonary, renal, neurologic or other organ disease
Evidence of significant non-compliance
Medical therapy has been optimal and no surgical procedure other than transplantation offers a realistic expectation of functional improvement and extension of life, in the presence of end-stage liver failure due to an irreversibly damaged liver
ANY ONE of the following:
Hepatocellular with ANY ONE of the following:
Cryptogenic cirrhosis
Chronic viral hepatitis
Autoimmune hepatitis
Alpha-1 antitrypsin deficiency
Protoporphyria
Alcoholic cirrhosis including ALL of the following:
Confirmation of the abstinence of alcoholic for six months
Ongoing participation in a formal treatment program
Fulminant hepatic failure with ANY ONE of the following:
Viral hepatitis (if the etiology is thought to be related to IV drug use) with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Drugs or toxins with ALL the following:
Confirmation of the abstinence from IV drugs for six months
Ongoing participation in a formal treatment program
Wilson’s disease
Cholestatic liver diseases with ANY ONE the following:
Biliary cirrhosis (primary or secondary)
Sclerosing cholangitis
Biliary atresia
Vascular disease (e.g., Budd-Chiari syndrome)
Primary hepatocellular carcinoma
Metabolic disorders with ANY ONE of the following:
Hemochromatosis
Glycogen storage disease
Familial hypercholesterolemia
Trauma and toxic reactions
Polycystic disease of the liver; with ANY ONE of the following:
Enlargement of liver impinging on respiratory function
Extremely painful enlargement of liver
Enlargement of liver significantly compressing and interfering with function of other abdominal organs
Liver retransplantation is considered medically appropriate with ALL the following:
Initial transplanted organ failure places the individual at risk with ANY ONE of the following:
Primary nonfunction of initial transplanted liver
Organ failure secondary to uncontrolled rejection
Organ failure secondary to hepatic artery thrombosis or portal vein thrombosis
Uncontrolled biliary tract complications - multiple intrahepatic biliary strictures
Patient evaluation determined that there is no other treatment available
High probability that individual will survive retransplantation
ADDITIONAL INFORMATION
The center responsible for the organ harvesting must comply with the United Network for Organ Sharing (UNOS) guidelines.
SOURCES
109th Congress: 1st Session: H. R. 1108: (2005, March). Liver research enhancement act of 2005. Retrieved January 10, 2006 from http://thomas.loc.gov.
109th Congress: 1st Session: H. R. 2051: (2005, May). Comprehensive immunosuppressive drug coverage for transplant patients act of 2005 (introduced in House). Retrieved January 10, 2006 http://thomas.loc.gov.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2007). Liver transplant (7.03.06). Retrieved November 30, 2007 from BlueWeb. (34 articles and/or guidelines reviewed)
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Deshpande, R. R., Rela, M., Girlanda, R., Bowles, M. J., Muiesan, P., Dhawan, A., et al. (2002). Long-term outcome of liver retransplantation in children. Transplantation, 74 (8), 1124-1120. Abstract retrieved March 25, 2003 from PubMed database.
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ECRI Institute. Health Technology Information Service. Windows on Medical Technology. (2005, September). Liver transplantation for treatment of hereditary amyloidosis-transthyretin type (ATTR). Retrieved December 21, 2005 from ECRI Institute. (83 articles and/or guidelines reviewed)
Fan, S., Lo, C., Liu, C., Yong, B., Chan, J. K., & Ng, I. O. (2000). Safety of donors in live donor liver transplantation using right lobe grafts. Archives of Surgery, 135 (3), 336-340. Abstract retrieved October 10, 2000 from PubMed database.
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Harihara, Y., Makuuchi, M., Kawarasaki, H., Takayama, T., Kubota, K., Ito, M., et al. (2000). Living-related liver transplantation in adults compared with children. Transplantation Proceedings, 32 (7), 2160-2161.
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Nakamura, M., Fuchinoue, S., Nakajima, I., Kitajima, K., Tojimbara, T., Takasaki, K., et al. (2001). Three cases of sequential liver-kidney transplantation from living-related donors. Nephrology Dialysis Transplantation, 16 (1), 166-168.
Pageaux, G. P., Bismuth, M., Perney, P., Costes, V., Jaber, S., Possoz, P., et al. (2003). Alcohol relapse after liver transplantation for alcoholic liver disease: Does it matter? Journal of Hepatology, 38 (5), 629-634. Abstract retrieved January 28, 2004 from PubMed database.
Pomfret, E. A., Pomposelli, J. J., Lewis, W. D., Gordon, F. D., Burns, D. L., Lally, A., et al. (2001). Live donor adult liver transplantation using right lobe grafts: Donor evaluation and surgical outcome. Archives of Surgery, 136 (4), 425-433. Abstract retrieved June 5, 2001 from PubMed database.
United Network of Organ Sharing. (2004, June). UNOS Organ distribution: Allocation of livers. Retrieved January 18, 2005 from http://www.optn.org/PoliciesandBylaws/policies/pdfs/policy_8.pdf.
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EFFECTIVE DATE |
4/16/2008 |
ID_BT
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