CurrentBlue Cross Blue Shield - MassachusettsPolicy BCBSA Reference Number: 7.03.06

Liver Transplantation (including combined liver-kidney and retransplantation)

Defines medical necessity criteria, investigational exclusions, prior authorization requirements, and coding guidance for liver transplantation, combined liver-kidney transplantation, and retransplantation for Commercial members (HMO, POS, PPO, Indemnity). Applies to inpatient procedures and describes clinical indications and contraindications.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyLiver Transplantation (including combined liver-kidney and retransplantation)

Policy CodePolicy BCBSA Reference Number: 7.03.06

Change TypeAnnual review; references updated

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient; providers must obtain authorization prior to inpatient liver transplant.

POLICY UPDATE CHANGES

10/2024 annual policy review updated summary and references; policy statements unchanged.

10/2023 annual policy review updated references and made minor editorial refinements; intent unchanged.

1/2021 Medicare information removed and cross-reference to Medicare Advantage Management MP #132 added.

MultipleCovered Indications

SeveralInvestigational Indications

RequiredPreauthorization for Inpatient

This policy defines medical necessity criteria and coverage parameters for liver transplantation including combined liver-kidney transplantation and liver retransplantation for Commercial members (Managed Care HMO/POS, PPO, and Indemnity). It applies to inpatient procedures and notes that precertification/prior authorization is required for all products when the procedure is performed inpatient. The scope includes clinical indications, contraindications, and coding guidance for transplant procedures.

Policy metadata

Policy numberBCBSA Reference Number: 7.03.06

SubjectLiver Transplantation (including combined liver-kidney and retransplantation)

StatusCURRENT

Last review date2024-10

Scope summaryDefines medical necessity criteria, investigational exclusions, prior authorization requirements, and coding guidance for liver transplantation, combined liver-kidney transplantation, and retransplantation for Commercial members; applies to inpatient procedures and describes clinical indications and contraindications.

Preauthorization for InpatientRequired

Medical-Necessity Criteria

Medically Necessary Indications

Liver transplantation may be considered MEDICALLY NECESSARY for carefully selected individuals when ALL of the following apply:

ALL of the following

Patient has end-stage liver failure due to irreversibly damaged liver (end-stage liver disease).
Etiologies include hepatocellular diseases, cholestatic liver diseases, vascular disease, primary hepatocellular carcinoma, select pediatric malignancies, metabolic/inborn errors, trauma/toxic reactions, and miscellaneous causes listed.
ONE of the listed etiologies
- Hepatocellular diseases (e.g., alcoholic liver disease; viral hepatitis A,B,C or non-A non-B; alpha-1 antitrypsin deficiency; autoimmune hepatitis; hemochromatosis; nonalcoholic steatohepatitis; protoporphyria; Wilson's disease).
- Cholestatic liver diseases (e.g., primary sclerosing cholangitis with secondary biliary cirrhosis; primary biliary cirrhosis; biliary atresia).
- Vascular disease (e.g., Budd-Chiari syndrome).
- Primary hepatocellular carcinoma (subject to appropriate selection criteria such as Milan criteria and transplant program assessment).
- Polycystic liver disease with massive hepatomegaly causing obstruction or functional impairment with ONE of: extremely painful enlargement; enlargement impinging on respiratory function; enlargement significantly compressing/interfering with other abdominal organs.
- Unresectable hilar (extrahepatic/perihilar) cholangiocarcinoma (when treated per accepted protocols, e.g., neoadjuvant chemoradiation followed by transplant).
- Pediatric nonmetastatic hepatoblastoma.
- End-stage liver disease in children (including Alagille's syndrome, intrahepatic bile duct paucity).
- Other listed indications including amyloidosis, familial amyloid polyneuropathy, cryptogenic cirrhosis, familial cholestasis.
Patients prioritized per OPTN/UNOS criteria (Status 1A/1B, MELD/PELD scores) as clinically appropriate.
Selection and prioritization follow transplant program and national allocation policies.

Medically Necessary - Liver Retransplantation

Liver retransplantation may be considered MEDICALLY NECESSARY when ALL of the following apply:

ALL of the following

Patient has failed prior liver transplant due to hepatic artery thrombosis, primary nonfunction graft, chronic rejection, recurrent non-neoplastic disease causing late graft failure, or ischemic type biliary lesions after donation after cardiac death.
Patient otherwise meets criteria for transplant candidacy as per original transplantation criteria.

Medically Necessary - Combined Liver-Kidney Transplant

Combined liver-kidney transplantation may be considered MEDICALLY NECESSARY when ALL of the following apply:

ALL of the following

Patient qualifies for liver transplantation.
Patient has advanced irreversible kidney disease (meets criteria for kidney transplant).
Indications in children are rare and often congenital (liver-based metabolic abnormalities affecting kidney or structural diseases affecting both organs).

Investigational / Not Medically Necessary & Contraindications

Investigational / Not Medically Necessary Indications

Liver transplantation is considered INVESTIGATIONAL (not medically necessary) in the following situations:

ANY of the following

Individuals with neuroendocrine tumors metastatic to the liver.
Individuals with intrahepatic cholangiocarcinoma.
Individuals with ongoing alcohol and/or drug abuse (evidence for abstinence varies; generally a minimum of 3 months abstinence is required by transplant programs).
Individuals with hepatocellular carcinoma that has extended beyond the liver.
All other situations not specifically described as medically necessary are investigational.

Contraindications / Exclusions (Coverage Denial Conditions)

Liver transplantation is not covered when ANY of the following are present:

ANY of the following

Recent malignancy with high risk of recurrence.
Known current malignancy, including metastatic cancer.
Untreated systemic infection making immunosuppression unsafe, including chronic infection.
Other irreversible end-stage disease not attributed to liver disease.
Systemic disease that could be exacerbated by immunosuppression.

Provider Actions / Operational Requirements

Prior Authorization

Precertification/Preauthorization Required for Inpatient Procedures

Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient; providers must obtain authorization prior to inpatient liver transplant.

Authorization is required prior to inpatient liver transplant and applies to all products.

Documentation Required

Documentation for Prior Malignancy

When the patient has a recently treated malignancy, the transplant team must submit a statement explaining why the patient is an appropriate candidate and include an assessment of risk of recurrence.

Operational requirement: this statement is required for cases with recently treated malignancy.

Background & Evidence

Liver transplantation is described as the treatment of last resort for patients with end-stage liver disease and can be lifesaving or substantially improve quality of life. Transplant recipients require lifelong immunosuppression to prevent allograft rejection. Patients are prioritized for donor livers by OPTN/UNOS allocation criteria, including Status 1A/1B designations and scoring using the MELD/PELD systems. To expand the donor supply, programs use living donor and split graft strategies (adult and pediatric living-donor segmental grafts, right or left lobes, left lateral segments) when appropriate.

Evidence summaries

Overall evidence for standard indicationsSufficient to determine improvement in net health outcome (registry studies, systematic reviews)

Intrahepatic cholangiocarcinoma outcome evidenceInsufficient — registry and observational studies report 5-year survival often <30%; evidence insufficient to determine improved net health outcome

Neuroendocrine tumors metastatic to liverInsufficient evidence — systematic reviews/case series heterogeneous; selection criteria unclear

Definitions:

• MELD/PELD — Model for End-stage Liver Disease and Pediatric End-stage Liver Disease scoring systems used to prioritize patients for transplant.

• OPTN/UNOS — Organ Procurement and Transplantation Network / United Network for Organ Sharing, the organ allocation authorities that establish prioritization (e.g., Status 1A/1B and MELD/PELD-based allocation).

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
0FB14ZZ	Excision of Right Lobe Liver, Percutaneous Endoscopic Approach
0FB20ZZ
0FB23ZZ
0FB2AZZ	Excision of Left Lobe Liver, Percutaneous Endoscopic Approach
0FT00ZZ	Resection of Liver, Open Approach

Name	Number	Type	Effective Date
National Coverage Determination for Adult Liver Transplantation for Malignancies	NCD referenced in document	NCD

OpenPayer

Liver Transplantation (including combined liver-kidney and retransplantation)

Coverage Summary

Medical-Necessity Criteria

Investigational / Not Medically Necessary & Contraindications

Coding

Provider Actions / Operational Requirements

Background & Evidence

Medicare Determinations

Revision History