198 Form

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Medical Policy Liver Transplant and Combined Liver-Kidney Transplant Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History
• Endnotes Policy Number: 198

BCBSA Reference Number: 7.03.06 (For Plan internal use only) Related Policies
None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Note: This medical policy applies to adults and children.

A liver transplant using a cadaver or living donor may be considered 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:

A. Hepatocellular diseases • Alcoholic liver disease • Viral hepatitis (either A, B, C, or non-A, non-B)
• Autoimmune hepatitis • Alpha-1 antitrypsin deficiency • Hemochromatosis • Metabolic dysfunction-associated steatohepatitis (MASH) • Protoporhyria • Wilson’s disease

B. Cholestatic liver diseases • Primary biliary cirrhosis • Primary sclerosing cholangitis with development of secondary biliary cirrhosis • Biliary atresia

C. Vascular disease • Budd-Chiari Syndrome

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D. Primary hepatocellular carcinoma

E. Inborn errors of metabolism

F. Trauma and toxic reactions

G. Miscellaneous • Familial amyloid polyneuropathy • Amyloidosis1 • Cryptogenic cirrhosis1 • End-stage liver disease in children1 • Familial cholestasis1 • Intrahepatic bile duct paucity (Alagille’s syndrome).1

Liver transplantation may be considered MEDICALLY NECESSARY in patients with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.
One of the following complications should be present: • 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 transplantation may be considered MEDICALLY NECESSARY in individuals with unresectable hilar (extrahepatic) cholangiocarcinoma.

Liver transplantation may be considered MEDICALLY NECESSARY in pediatric patients 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 INVESTIGATIONAL in the following situations: • Individuals with intrahepatic cholangiocarcinoma
• Individuals with neuroendocrine tumors metastatic to the liver. • Individuals with hepatic adenoma
• Individuals with unresectable colorectal liver metastases • Individuals with epithelioid hemangioendothelioma (HEHE).

Liver transplantation is considered INVESTIGATIONAL in the following patients: • Individuals with hepatocellular carcinoma that has extended beyond the liver • 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 INVESTIGATIONAL in all other situations not described above.

In addition to the above information, we do not cover liver transplantation when any of the following conditions are present: • Known current malignancy, including metastatic cancer

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• Recent malignancy with high risk of recurrence o Note: the assessment of risk of recurrence for a previously treated malignancy is made by the transplant team; providers must submit a statement with an explanation of why the patient with a recently treated malignancy is an appropriate candidate for a transplant. • Untreated systemic infection making immunosuppression unsafe, including chronic infection • Other irreversible end-stage disease not attributed to liver disease • History of cancer with a moderate risk of recurrence • Systemic disease that could be exacerbated by immunosuppression • Psychosocial conditions or chemical dependency affecting ability to adhere to therapy o Patients with liver disease related to alcohol or drug abuse must be actively involved in a substance abuse treatment program (e.g., weekly meetings such as Alcoholics Anonymous, partial or full day programs or inpatient programs).

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This procedure is performed in the inpatient setting. Commercial PPO and Indemnity This procedure is performed in the inpatient setting. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity: CPT Codes CPT codes: Code Description 47135 Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age

ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 0FB03ZZ Excision of Liver, Percutaneous Approach 0FB00ZZ Excision of Liver, Open Approach 0FB04ZZ Excision of Liver, Percutaneous Endoscopic Approach 0FB10ZZ Excision of Right Lobe Liver, Open Approach 0FB13ZZ Excision of Right Lobe Liver, Percutaneous Approach 0FB14ZZ Excision of Right Lobe Liver, Percutaneous Endoscopic Approach

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0FB20ZZ Excision of Left Lobe Liver, Open Approach 0FB23ZZ Excision of Left Lobe Liver, Percutaneous Approach 0FB24ZZ Excision of Left Lobe Liver, Percutaneous Endoscopic Approach 0FT00ZZ Resection of Liver, Open Approach 0FY00Z0 Transplantation of Liver, Allogeneic, Open Approach 0FY00Z1 Transplantation of Liver, Syngeneic, Open Approach

Description 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.1, Many advances have been made in the last several decades to reduce perioperative complications. Available data support 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 the 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 liver donation after a brain or cardiac death or with a liver segment donation from a living donor. Certain populations are prioritized as Status 1A (eg, 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 organ 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.

Summary Description Liver transplantation is currently the treatment of last resort for individuals with end-stage liver disease. Liver transplantation may be performed with a liver donation after a brain or cardiac death or with a liver segment donation from a living donor. Individuals are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network and the United Network of Organ Sharing. The severity of illness is determined by the Model for End-stage Liver Disease and Pediatric End-stage Liver Disease scores.

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 (OS), 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), the 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 metabolic dysfunction-associated steatohepatitis, OS rates have been shown to be similar to other indications for liver transplantation. The evidence is sufficient to determine that the technology results in an 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 OS, morbid events, and treatment-related morbidity and mortality. In the past, long-term outcomes in patients with primary

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hepatocellular malignancies had been poor (19%) compared with the OS of liver transplant recipients. However, the recent use of standardized patient selection criteria (eg, the Milan criteria diameter) has dramatically improved OS rates. In the appropriately selected patients, a 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 an improvement in the net health outcome.

For individuals who have extrahepatic cholangiocarcinoma who receive a liver transplant, the evidence includes systematic reviews of observational studies and individual registry studies. Relevant outcomes include OS, 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 an 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 OS, 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 OS, 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 that the technology results in an improvement in the net health outcome.

For individuals who have metastatic neuroendocrine tumors who receive a liver transplant, the evidence includes systematic reviews of case series. Relevant outcomes include OS, 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 that the technology results in an improvement in the net health outcome.

For individuals who have unresectable colorectal liver metastases who receive a liver transplant, the evidence includes one randomzied controlled trial (RCT) and nonrandomized studies. Relevant outcomes include OS, morbid events, and treatment-related morbidity and mortality. Five-year OS was improved with liver transplant compared with standard of care in the RCT. Nonrandomized studies indicate improved OS compared with historic controls. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have unresectable hepatic epithelioid hemangioendothelioma (HEHE) who receive a liver transplant, the evidence includes nonrandomized, observational studies. Relevant outcomes include OS, morbid events, and treatment-related morbidity and mortality. Posttransplant survival among patients with HEHE was similar to those undergoing liver transplant for other indications. Based on the lack of standard treatment and the rare tumor type, high-quality comparative trials are unlikely to be conducted for hepatic transplant in HEHE. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have hepatic adenomas who receive a liver transplant, the evidence includes nonrandomized observational studies and a systematic review of these studies. Relevant outcomes include OS, morbid events, and treatment-related morbidity and mortality. The systematic review found 5-year OS rates of 95% but noted a lack of optimal selection criteria for patients with hepatic adenoma who would benefit from hepatic transplant. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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For individuals who have pediatric hepatoblastoma who receive a liver transplant, the evidence includes case series. Relevant outcomes include OS, 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 the United Network for Organ Sharing criteria for patients eligible for liver transplantation. The evidence is sufficient to determine that the technology results in an 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 OS, 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 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, the evidence includes a systematic review of retrospective observational studies in adults and several individual registry studies. Relevant outcomes include OS, morbid events, and treatment-related morbidity and mortality. Most of the evidence involves adults with cirrhosis and kidney failure. Indications for combined liver-kidney transplant 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 would suggest that combined liver-kidney transplant 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.

Policy History Date Action 2/2026 Annual policy review. Policy updated with literature review through July 23, 2025; references added. Policy statements updated to include the indications unresectable colorectal liver metastases, hepatic epithelioid hemangioendothelioma, hepatic adenomas, and intrahepatic cholangiocarcinoma as investigational for liver transplant. A note was added to indicate that this policy applies to adults and children. Effective 2/1/2026. 10/2024 Annual policy review. Summary and references updated. Policy statements unchanged. 10/2023 Annual policy review. References added and updated. Minor editorial refinements to policy statements; intent unchanged. 9/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
10/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2018 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2018 Annual policy review.
Combined liver-kidney transplantation considered medically necessary. Clarified coding information. Policy title changed to Liver Transplant and Combined Liver- Kidney Transplant. Effective 2/1/2018.
4/2016 Policy statement on psychosocial conditions or chemical dependency affecting ability to adhere to therapy clarified. 4/1/2016

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1/2016 Medical policy criteria clarified. Clarified coding information. 1/1/2016 11/2015 Added coding language. 3/2015 Annual policy review. New references added. 10/2014 Medical policy remediation: New indications for non-coverage. Coding information clarified. Effective 10/1/2014. 6/2014 Annual policy review. New medically necessary and investigational indications described. Effective 6/1/2014. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, Effective 10/2015. 12/2013 Removed ICD-9 diagnosis codes as the policy requires prior authorization. 7/2013 Annual policy review. New medically and investigational indications described. Effective 7/1/2013. 11/2012 CMS NCD medical policy review. Changes to policy statements. Effective 6/21/2012. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 11/2009 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 2/2009 Annual policy review. No changes to policy statements. 11/2008 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 11/2007 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 8/2007 Annual policy review. No changes to policy statements.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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    Endnotes

    1 Based on expert opinion, NEMCI