Medical policy: Liver Transplant and Combined Liver-Kidney Transplant

Policy number: MP 9.006

Effective date: 2/1/2026

Policy

A liver transplant, using a cadaver or living donor, is medically necessary for carefully selected individuals with end-stage liver failure due to irreversibly damaged livers.

Etiologies of end-stage liver disease include, but are not limited to, the following:

• Hepatocellular diseases
  • Alcoholic liver disease
  • Viral hepatitis (either A, B, C, or non-A, non-B)
  • Autoimmune hepatitis
  • Alpha-1 antitrypsin deficiency
  • Hemochromatosis
  • Non-alcoholic steatohepatitis
  • Protoporphyria
  • Wilson disease
• Cholestatic liver diseases
  • Primary biliary cirrhosis
  • Primary sclerosing cholangitis with development of secondary biliary cirrhosis
  • Biliary atresia
• Vascular disease
  • Budd-Chiari syndrome
• Primary hepatocellular carcinoma (see Policy Guidelines section for individual selection criteria)
• Inborn errors of metabolism
• Trauma and toxic reactions
• Miscellaneous
  • Familial amyloid polyneuropathy

Liver transplantation may be considered medically necessary in individuals with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.

Liver transplantation may be considered medically necessary in individuals with unresectable hilar cholangiocarcinoma (see Policy Guidelines for individual selection criteria).

Liver transplantation may be considered medically necessary in pediatric individuals with nonmetastatic hepatoblastoma.

Liver retransplantation may be considered medically necessary in individuals with:

• Primary graft nonfunction
• Hepatic artery thrombosis
• Chronic rejection
• Ischemic type biliary lesions after donation after cardiac death
• Recurrent non-neoplastic disease causing late graft failure

Combined liver-kidney transplantation may be considered medically necessary in individuals who qualify for liver transplantation and have advanced irreversible kidney disease.

Liver transplantation is considered investigational in the following individuals as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure:

• Individuals with an intrahepatic cholangiocarcinoma
• Individuals with neuroendocrine tumors metastatic to the liver

Liver transplantation is considered investigational in the following individuals:

• Individuals with hepatocellular carcinoma that has extended beyond the liver (see Policy Guidelines)
• Individuals with ongoing alcohol and/or drug abuse (evidence for abstinence may vary among liver transplant programs, but generally a minimum of 3 months is required)

Liver transplantation is considered investigational in all other situations not described above as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Policy guidelines

Contraindications

Potential contraindications subject to the judgment of the transplant center include:

1. Known current malignancy, including metastatic cancer
2. Recent malignancy with high risk of recurrence
3. Untreated systemic infection making immunosuppression unsafe, including chronic infection
4. Other irreversible end-stage disease not attributed to liver disease
5. History of cancer with a moderate risk of recurrence
6. Systemic disease that could be exacerbated by immunosuppression
7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Note that liver transplantation for those with T3 hepatocellular carcinoma (HCC) is not prohibited by United Network for Organ Sharing (UNOS) guidelines, but these individuals do not receive any priority on the waiting list. All individuals with HCC awaiting transplantation are reassessed at 3‑month intervals. Those whose tumors have progressed and are no longer T2 tumors will lose the additional allocation points.

Additionally, nodules identified through imaging of cirrhotic livers are given a Class 5 designation. Class 5B and 5T nodules are eligible for automatic priority. Class 5B criteria consist of a single nodule 2 cm or larger and up to 5 cm (T2 stage) that meets specified imaging criteria. Class 5T nodules have undergone subsequent locoregional treatment after being automatically approved on initial application or extension. A single Class 5A nodule (greater than 1 cm and less than 2 cm) corresponds to T1 HCC and does not qualify for automatic priority. However, combinations of Class 5A nodules are not automatic priority if they meet stage T2 criteria. Class 5X lesions are outside of stage T2 and are not eligible for automatic exception points. Nodules less than 1 cm are considered indeterminate and are not considered for additional priority. Therefore, the UNOS allocation system provides strong incentives to use locoregional therapies to downsize tumors to T2 status and to prevent progression while on the waiting list.

Cholangiocarcinoma

According to Organ Procurement and Transplantation Network (OPTN) policy on liver allocation, candidates with cholangiocarcinoma (CCA) meeting the following criteria will be eligible for a Model for End‑stage Liver Disease (MELD) or Pediatric End‑stage Liver Disease (PELD) exception with a 10% mortality equivalent increase every 3 months:

• Centers must submit a written protocol for patient care to the OPTN and UNOS Liver and Intestinal Organ Transplantation Committee before requesting a MELD score exception for a candidate with cholangiocarcinoma. This protocol should include selection criteria, administration of neoadjuvant therapy before transplantation, and operative staging to exclude individuals with regional hepatic lymph node metastases, intrahepatic metastases, and/or extrahepatic disease. The protocol should include data collection as deemed necessary by the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee.
• Candidates must satisfy diagnostic criteria for hilar CCA: malignant‑appearing stricture on cholangiography and one of the following: carbohydrate antigen 19‑9 greater than 100 U/mL, or biopsy or cytology results demonstrating malignancy, or aneuploidy. The tumor should be considered unresectable on the basis of technical considerations or underlying liver disease (e.g., primary sclerosing cholangitis).
• If cross‑sectional imaging studies (computed tomography [CT] scan, ultrasound, magnetic resonance imaging [MRI]) demonstrate a mass, the mass should be less than 3 cm.
• Intra‑ and extrahepatic metastases should be excluded by cross‑sectional imaging studies of the chest and abdomen at the time of initial exception and every 3 months before score increases.
• Regional hepatic lymph node involvement and peritoneal metastases should be assessed by operative staging after completion of neoadjuvant therapy and before liver transplantation. Endoscopic ultrasound-guided aspiration of regional hepatic lymph nodes may be advisable to exclude individuals with obvious metastases before neoadjuvant therapy is initiated.
• Transperitoneal aspiration or biopsy of the primary tumor (either by endoscopic ultrasound, operative, or percutaneous approaches) should be avoided because of the high risk of tumor seeding associated with these procedures.

Donor criteria: Living donor liver transplant

Donor morbidity and mortality are prime concerns in donors undergoing right lobe, left lobe, or left lateral segment donor partial hepatectomy as part of living donor liver transplantation. Partial hepatectomy is a technically demanding surgery, the success of which may be related to the availability of an experienced surgical team. In 2000, the American Society of Transplant Surgeons proposed the following guidelines for living donors:

• Should be healthy individuals who are carefully evaluated and approved by a multidisciplinary team including hepatologists and surgeons to assure that they can tolerate the procedure
• Should undergo evaluation to assure that they fully understand the procedure and associated risks
• Should be of legal age and have sufficient intellectual ability to understand the procedures and give informed consent
• Should be emotionally related to the recipients
• Must be excluded if the donor is felt or known to be coerced
• Need to have the ability and willingness to comply with long-term follow-up

Cross-reference:

• MP 9.013 Isolated Small Bowel Transplant and Small Bowel/Liver and Multivisceral Transplant

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/Background

Solid organ transplantation offers a treatment option for patients with different types of end stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Liver transplantation

Liver transplantation is routinely performed as a treatment of last resort for patients with end‑stage liver disease. Liver transplantation may be performed with a living donation after brain or cardiac death or with a live segment donation from a living donor. Certain populations are prioritized as Status 1A (e.g., acute liver failure with a life expectancy of fewer than 7 days without a liver transplant) or Status 1B (pediatric patients with chronic liver disease). Following Status 1, donor livers are prioritized to those with the highest scores on the Model for End‑stage Liver Disease (MELD) and Pediatric End‑stage Liver Disease (PELD) scales.

Due to the scarcity of donor livers, a variety of strategies have been developed to expand the donor pool. For example, a split graft refers to dividing a donor liver into 2 segments that can be used for 2 recipients. Living donor (LD) liver transplantation (LT) is now commonly performed for adults and children from a related or unrelated donor. Depending on the graft size needed for the recipient, either the right lobe, left lobe, or the left lateral segment can be used for LD LT.

In addition to addressing the problem of donor scarcity, LD LT allows the procedure to be scheduled electively before the recipient’s condition deteriorates or serious complications develop. Living donor LT also shortens the preservation time for the donor liver and decreases disease transmission from donor to recipient.

Regulatory status

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).

The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

Rationale

Summary of evidence

For individuals who have hepatocellular disease who receive a liver transplant, the evidence includes registry studies and systematic reviews. Relevant outcomes include overall survival, morbid events, and treatment‑related morbidity and mortality. Studies on liver transplantation for viral hepatitis have found that survival is lower than for other liver diseases. Although these statistics raise questions about the most appropriate use of a scarce resource (donor livers), long‑term survival rates are significant in a group of patients who have no other treatment options. Also, survival can be improved by the eradication of the hepatitis virus before transplantation. For patients with non‑alcoholic steatohepatitis (NASH), overall survival rates have been shown to be similar to other indications for liver transplantation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have primary hepatocellular carcinoma who receive a liver transplant, the evidence includes systematic reviews of observational studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. In the past, long-term outcomes in patients with primary hepatocellular malignancies had been poor compared with the overall survival of liver transplant recipients. However, the recent use of standardized patient selection criteria (e.g., the Milan criteria diameter) has dramatically improved overall survival rates. In appropriately selected patients, liver transplant has been shown to result in higher survival rates than resection. In patients who present with unresectable organ-confined disease, transplant represents the only curative approach. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have extrahepatic cholangiocarcinoma who receive a liver transplant, the evidence includes individual registry studies and systematic reviews of observational studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. For patients with extrahepatic (hilar or perihilar) cholangiocarcinoma who are treated with adjuvant chemotherapy, 5-year survival rates have been reported as high as 76%. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have intrahepatic cholangiocarcinoma who receive a liver transplant, the evidence includes registry studies and a systematic review of observational studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. In a registry study comparing outcomes in patients with intrahepatic cholangiocarcinoma who received liver transplantation to those who received surgical resection of the liver, no differences were found in overall survival, length of stay, or unplanned 30-day readmission rates between groups. Additional studies reporting survival rates in patients with intrahepatic cholangiocarcinoma or in mixed populations of patients with extrahepatic and intrahepatic cholangiocarcinoma have reported 5-year survival rates of less than 30%. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have metastatic neuroendocrine tumors who receive a liver transplant, the evidence includes systematic reviews of case series. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. In select patients with nonresectable, hormonally active liver metastases refractory to medical therapy, liver transplantation has been considered as an option to extend survival and minimize endocrine symptoms. While some centers may perform liver transplants on select patients with neuroendocrine tumors, the available studies are limited by their heterogeneous populations. Further studies are needed to determine the appropriate selection criteria. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have pediatric hepatoblastoma who receive a liver transplant, the evidence includes case series. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. The literature on liver transplantation for pediatric hepatoblastoma is limited, but case series have demonstrated good outcomes and high rates of long-term survival. Additionally, nonmetastatic pediatric hepatoblastoma is among in United Network for Organ Sharing criteria for patients eligible for liver transplantation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have a failed liver transplant who receive a liver retransplant, the evidence includes observational studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. Case series have demonstrated favorable outcomes with liver retransplantation in certain populations, such as when criteria for an original liver transplantation are met for retransplantation. While some evidence has suggested outcomes after retransplantation may be less favorable than for initial transplantation in some patients, long-term survival benefits have been demonstrated. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with indications for liver and kidney transplant who receive a combined liver-kidney transplant (CLKT), the evidence includes a systematic review of retrospective observational studies in adults and several individual registry studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. Most of the evidence involves adults with cirrhosis and kidney failure. Indications for CLKT in children are rare and often congenital and include liver-based metabolic abnormalities affecting the kidney, along with structural diseases affecting both the liver and kidney. In both adults and children, comparisons with either liver or kidney transplantation alone suggest that CLKT is no worse, and possibly better, for graft and patient survival. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Albumin refers to one of a group of simple proteins widely distributed in plant and animal tissues. It is found in the blood as serum albumin, in milk as lactalbumin, and in egg white as ovalbumin.

Bilirubin refers to the orange-colored or yellowish pigment in the bile. It is derived from hemoglobin of red blood cells that have completed their life span and are destroyed and ingested by the macrophage system of the liver, spleen, and red bone marrow.

Blue Quality Centers for Transplant (BQCT) is a cooperative effort of the Blue Cross and Blue Shield Plans, the Blue Cross and Blue Shield Association, and participating medical institutions to provide patients who need transplants with access to leading centers through a coordinated, streamlined program of transplant management.

Cadaver refers to a dead body or corpse.

End-stage refers to the final phase of a disease process.

Extrahepatic refers to outside or unrelated to the liver.

Hepatocellular refers to the cells of the liver.

Macrovascular refers to the larger blood vessels in the body.

Prothrombin time is the time it takes for clotting to occur after prothromboplastin and calcium are added to decalcified plasma.

United Network of Organ Sharing (UNOS) is an organization established in 1984 to facilitate donation of organs for possible transplantation.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Covered when medically necessary:

References

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