Liver transplantation involves replacing an end-stage diseased liver with a healthy one. The healthy liver is obtained from a donor who is brain dead with artificially sustained cardiopulmonary function. A partial liver can also be donated from a living related donor.

Liver transplantation is covered for the indications listed below for adolescents and adults with either:

• A model of end-stage liver disease (MELD) score greater than 10; or
• Who are approved for transplant by the United Network for Organ Sharing (UNOS) Regional Review Board; and
• Children less than 12 years of age who meet the transplanting institution's selection criteria.

In the absence of an institution's selection criteria, liver transplantation will be covered for adolescents and adults with a MELD score greater than 10 or who are approved by the UNOS Regional Review Board and for children who meet the medical necessity criteria specified below (not an all-inclusive list).

• Cholestatic liver diseases
  • Biliary atresia; or
  • Primary biliary cirrhosis; or
  • Primary sclerosing cholangitis with development of secondary biliary cirrhosis ; or
• Hepatocellular diseases:
  • Alcoholic liver disease; or
  • Cryptogenic cirrhosis; or
  • Viral hepatitis (either A, B, C, or non-A, non-B); or
  • Idiopathic autoimmune hepatitis; or
  • Alpha-1 antitrypsin deficiency; or
  • Hemochromatosis; or
  • Non-alcoholic steatohepatitis; or
  • Protoporphyria; or
  • Wilson's disease; or
• Hepatorenal Syndrome:
  • GFR <40ml/min; and
  • All other causes for renal failure have been excluded; or 
• Vascular disease
  • Budd-Chiari syndrome; or
  • Veno-occlusive disease; or
• Malignancies:
  • Primary hepatocellular carcinoma confined to the liver when all of the following criteria are met:
    • Any lung metastases have been shown to be responsive to chemotherapy; and
    • Member is not a candidate for subtotal liver resection; and
    • Member meets UNOS criteria for tumor size and number; and
    • There is no identifiable extrahepatic spread of tumor to surrounding lymph nodes, abdominal organs, bone or other sites; and
    • There is no macrovascular involvement; or
  • Hepatoblastomas in children when all of the following criteria are met:
    • Member is not a candidate for subtotal liver resection; and
    • Member meets UNOS criteria for tumor size and number; and
    • There is no identifiable extrahepatic spread of tumor to surrounding lungs, abdominal organs, bone or other sites. (Note: spread of hepatoblastoma to veins and lymph nodes does not disqualify a member for coverage of a liver transplant.); or 
  • Epithelioid hemangioendotheliomas (EHE); or;
  • Intrahepatic cholangiocarcinomas (i.e., cholangiocarcinomas confined to the liver); or
  • Large, unresectable fibrolamellar hepatocellular carcinomas; or
  • Metastatic neuroendocrine tumors (carcinoid tumors, apudomas, gastrinomas, glucagonomas) in persons with severe symptoms and with metastases restricted to the liver, who are unresponsive to adjuvant therapy after aggressive surgical resection including excision of the primary lesion and reduction of hepatic metastases; or
• Inborn errors of metabolism; or 
• Trauma and toxic reactions; or
• Miscellaneous:
  • Polycystic disease of the liver; or
  • Familial amyloid polyneuropathy; or
  • Portopulmonary hypertension (pulmonary hypertension associated with liver disease or portal hypertension) in persons with a mean pulmonary artery pressure by catheterization of less than 35 mm Hg; or
  • Toxic reactions (fulminant hepatic failure due to mushroom poisoning, acetaminophen (Tylenol) overdose, etc.); or
  • Trauma; or
  • Hepatopulmonary syndrome when the following selection criteria are met:
    • Arterial hypoxemia (PaO2 less than 60 mm Hg or AaO2 gradient greater than 20 mm Hg in supine or standing position); and
    • Chronic liver disease with non-cirrhotic portal hypertension; and
    • Intrapulmonary vascular dilatation (as indicated by contrast-enhanced echocardiography, technetium-99 macroaggregated albumin perfusion scan, or pulmonary angiography).

Liver transplantation may be considered medically necessary in patients with unresectable hilar cholangiocarcinoma.

Liver transplantation is considered experimental/investigational in ANY of the following situations:

• Patients with extrahepatic cholangiocarcinoma; or
• Patients with intrahepatic cholangiocarcinoma; or
• Patients with neuroendocrine tumors metastatic to the liver who have not met the medical necessity criteria identified above.

Liver transplantation is considered not medically necessary in the following patients:

• Patients with hepatocellular carcinoma that has extended beyond the liver; or
• Patients with ongoing alcohol and/or drug abuse.*

*NOTE:
Chronic Alcoholic Liver Disease
The following recommendations should be taken into consideration for those individuals diagnosed with “Chronic” alcoholic liver disease and are, most likely, on a liver transplant waiting list before a liver transplant is considered:

• Abstinence of substance abuse for a minimum of six (6) months; and
• Participation in a substance abuse/rehabilitation program, either through the facility transplant program or at a substance abuse clinic; and
• Consistent negative results of random blood or urine drug testing.

Acute Alcoholic Liver Disease
In acute alcoholic liver disease, there will be some patients who will not respond to or will continue to deteriorate despite medical therapy. In these cases, immediate intervention is expected to stabilize the patient, even if that intervention is immediate liver transplantation. It is also expected, that alcohol consumption will be addressed in the post liver transplant care when appropriate.

Potential contraindications for liver transplant recipients include, but are not limited to ANY of the following:

• Known current malignancy, including metastatic cancer not identified in any of the medical necessity criteria above; or
• Recent malignancy with high risk of recurrence; or
• Untreated systemic infection making immunosuppression unsafe, including chronic infection; or
• Other irreversible end-stage disease not attributed to liver disease; or
• History of cancer with a moderate risk of recurrence; or
• Systemic disease that could be exacerbated by immunosuppression; or
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy; or
• Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations; or
• Potential complications from immunosuppressive medications are unacceptable to the patient; or
• AIDS (diagnosis based on CDD definition of CD4 count, 200 cells/mm³) unless the following are noted:
  • CD4 count greater than 200 cells/mm³ for greater than six (6) months; and
  • HIV-1 RNA undetectable; and
  • On stable anti-retroviral therapy greater than three (3) months; and
  • No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm); and
  • Meeting all other criteria for liver transplantation.
• Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery; or
• Serious conditions that are unlikely to be improved by transplantation as life expectance can be finitely measured

Retransplantation

Liver retransplantation may be considered medically necessary in patients with:

• primary graft non-function; or
• hepatic artery thrombosis; or
• chronic rejection; or
• ischemic type biliary lesions after donation after cardiac death; or
• recurrent non-neoplastic disease causing late graft failure

The following guidelines are used to process claims for eligible transplant procedures:

• Payment should be made for transplant services performed for a recipient who is a plan patient, including the removal of an organ from a living donor or cadaver. Payment is also made for the removal of an organ from a living donor who is a Plan patient, even though the recipient is not. When only the recipient is a plan patient, donor benefits are limited to only those not provided or available to the donor from any other source. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.
• Payment may be made under the recipient's plan only when all other donor sources (e.g., other insurance coverage, government program funding, etc.) have been exhausted. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation. Removal of an organ from a cadaver is payable only when the recipient is a Plan patient.
• The above guidelines also apply to all preoperative testing. Once the donor has been established, payment may be made for the preoperative testing and medical examination for the donor in preparation for the surgery for the removal of the organ or tissue. The testing (e.g., pathology tests, chest x-ray, and EKG) and medical examination are medically necessary prior to the administration of general anesthesia and/or major surgery.
• Based on the above guidelines, payment should be made for those services provided by the surgeon for the removal of the organ from the living donor or cadaver for the actual transplant.
• Testing performed to determine donor compatibility is classified as screening because the potential donor is asymptomatic. Liability for potential donor testing lies with the potential donor’s health plan and is subject to contract provisions regarding such screening tests.
• Payment may not be made for the purchase price of human organs which are sold rather than donated to the recipient.
• Due to the nature of organ transplant surgery, team surgery is frequently involved. See Medical Policy Bulletin S-12, Team Surgery for additional information.