CurrentmediviewcurativePolicy MM-PNP-030

Liver Transplantation — Medical Necessity and Coverage Criteria

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Medical necessity criteria and requirements for liver transplantation evaluations and coverage determinations for members undergoing liver transplant or retransplant procedures, intended for the Medical Utilization Management department.

Policy Summary

Payermediviewcurative

PolicyLiver Transplantation — Medical Necessity and Coverage Criteria

Policy CodePolicy MM-PNP-030

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review Date

Key ActionObtain prior authorization and document MELD score or UNOS Regional Review Board approval as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MELD > 10MELD threshold

6 monthsAlcohol abstinence

MultipleCovered indications

AllowedRetransplantation

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CurrentmediviewcurativePolicy MM-PNP-030

Liver Transplantation — Medical Necessity and Coverage Criteria

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Policy Summary

Payermediviewcurative

PolicyLiver Transplantation — Medical Necessity and Coverage Criteria

Policy CodePolicy MM-PNP-030

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review Date

Key ActionObtain prior authorization and document MELD score or UNOS Regional Review Board approval as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MELD > 10MELD threshold

6 monthsAlcohol abstinence

MultipleCovered indications

AllowedRetransplantation

Coverage Criteria for Liver Transplantation

General eligibility (age-based and MELD/approval criteria)

Covered when ALL of the following are met

Age and disease severity/approval: Adolescents ≥12 years of age and adults with either a MELD score greater than 10 OR approval for transplant by the UNOS Regional Review Board OR who meet the transplant institution's selection criteria; children <12 years of age who meet the transplanting institution's selection criteria.MELD > 10

In the absence of an institution's selection criteria, requests for children, and for adolescents/adults with MELD ≤ 10 who are not UNOS-approved, are subject to medical necessity review.

Covered indications (etiologies)

Covered liver transplant indications include, but are not limited to, the following disease groups when medical necessity criteria are met

Cholestatic diseases: Biliary atresia; familial cholestatic syndromes; primary biliary cirrhosis; primary sclerosing cholangitis with development of secondary biliary cirrhosis.

Hepatocellular diseases: Alcoholic cirrhosis; chronic active hepatitis with cirrhosis (hepatitis B or C); cryptogenic cirrhosis; idiopathic autoimmune hepatitis; post-necrotic cirrhosis due to hepatitis B surface antigen negative state.

Malignancies: Primary hepatocellular carcinoma confined to the liver when all UNOS criteria for tumor size/number are met and there is no extrahepatic spread or macrovascular involvement; hepatoblastoma in members <12 meeting UNOS criteria for tumor size/number and no identifiable extrahepatic spread (venous/lymph node spread does not disqualify); select other tumors such as epithelioid hemangioendotheliomas, intrahepatic cholangiocarcinomas confined to the liver, large unresectable fibrolamellar HCCs, and metastatic neuroendocrine tumors limited to the liver with severe symptoms unresponsive to therapy and after aggressive resection.UNOS tumor criteria

Vascular diseases: Budd-Chiari syndrome; veno-occlusive disease.

Metabolic disorders: Alpha-1 antitrypsin deficiency; hemochromatosis; inborn errors of metabolism; protoporphyria; Wilson's disease.

Miscellaneous: Familial amyloid polyneuropathy; polycystic disease of the liver; porto-pulmonary hypertension with mean pulmonary artery pressure < 35 mm Hg; toxic fulminant hepatic failure (e.g., mushroom poisoning, acetaminophen overdose); trauma; hepato-pulmonary syndrome meeting arterial hypoxemia (PaO2 < 60 mm Hg or AaO2 gradient > 20 mm Hg), chronic liver disease with non-cirrhotic portal hypertension, and demonstration of intrapulmonary vascular dilatation.mean PAP < 35 mm Hg; PaO2 < 60 mm Hg or AaO2 gradient > 20 mm Hg

Retransplantation

Retransplant coverage: Retransplantation following a failed liver transplant is medically necessary if the initial transplant was performed for a covered indication.

The following interventions are designated Experimental and Investigational and are therefore not covered: basiliximab for induction immunosuppression in liver transplantation; bioartificial liver transplantation; various biomarkers for diagnosis of acute allograft rejection (including NOx, serum amyloid A, procalcitonin, peripheral blood T-cell activation, IL-2 receptor, guanylate-binding protein-2 mRNA, graft-derived cell-free DNA, pi- and alpha-glutathione S-transferases, and soluble HLA class I antigens); ectopic or auxiliary liver transplantation; everolimus for prevention of rejection after liver transplantation; factor V Leiden and F2 testing in certain partial liver transplant settings; hepatocyte (hepatocellular) transplantation; hypothermic and normothermic machine perfusion techniques as listed; MARS for specific indications; and other items listed in the policy as investigational.

The policy explicitly excludes the following as Experimental and Investigational and not eligible for coverage: the OrganOx metra System for transportation and preservation of the liver prior to transplantation; perioperative use of vasopressin and perioperative use of sorafenib in liver transplantation; scaffold-based transplantation (combining xeno-organ and cell transplantations) as an alternative to orthotopic liver transplant; transient elastography to diagnose acute cellular rejection after liver transplantation; ursodeoxycholic acid (UDCA) when used as an adjuvant to prevent acute cellular rejection; and xenotransplantation.

Liver transplantation is considered not medically necessary for members with any of the following absolute contraindications: active sepsis outside the biliary tract, when other effective medical or surgical treatments are available, or in the presence of significant organ system failure other than the kidney, liver, or small bowel.

Key Clinical Thresholds and Codes

inv-07: MELD threshold

MELD threshold> 10

Applies toAdolescents ≥12 and adults as part of eligibility criteria

Use in determinationOne of three pathways for medical necessity: MELD >10 OR UNOS approval OR meeting transplant center criteria

inv-08: Alcohol abstinence

Required period of abstinence≥ 6 months

ContextPre-evaluation requirement for transplant candidacy

Denial riskRequests may be denied if alcohol abstinence <6 months

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required; age- and MELD-based conditions

Submit prior authorization for all liver transplant requests. Adults and adolescents ≥12 must meet one of the following: MELD score >10, approval by the UNOS Regional Review Board, or meet the transplanting institution’s selection criteria; children <12 must meet the transplanting institution’s selection criteria. Requests for adolescents/adults with MELD ≤10 or for children without institution criteria will be subject to medical necessity review.

Adolescents ≥12 and adults: MELD >10 OR UNOS Regional Review Board approval OR transplant center selection criteria
Children <12: must meet transplanting institution’s selection criteria
Requests are subject to medical necessity review if institution criteria absent or MELD ≤10 without UNOS approval

Prior Authorization

Prior authorization and experimental/investigational interventions

Prior authorization applies to transplant-related services and interventions; services listed as Experimental and Investigational in the policy may be denied upon review.

Evaluation and Institutional Requirements

Documentation Required

Document evaluation findings (MELD, UNOS approval, tumor staging, pulmonary/hemodynamic data)

Evaluation documentation must demonstrate the member’s MELD score or UNOS approval, tumor size/number consistent with UNOS criteria for HCC or hepatoblastoma, absence of extrahepatic spread or macrovascular involvement for malignancies, and relevant pulmonary/hemodynamic data for porto-pulmonary or hepato-pulmonary syndromes.

Document MELD score or UNOS approval
For HCC/hepatoblastoma: tumor size/number per UNOS and no extrahepatic spread or macrovascular involvement
For porto-pulmonary: mean pulmonary artery pressure < 35 mm Hg
For hepato-pulmonary: PaO2 < 60 mm Hg or AaO2 gradient > 20 mm Hg and evidence of intrapulmonary vascular dilatation

Note

Medical UM associates must review and apply the policy’s evaluation/documentation requirements

Medical UM associates and reviewers must read and comprehend this procedure; while the policy references documentation and evaluation requirements, specific procedural details are to be obtained from the full policy and supporting documentation as needed.

Candidate Suitability Criteria

Candidate suitability

Candidate selection requires medical, psychosocial, and institutional criteria.

Pre-evaluation requirements: Candidate must be free of cancer outside the liver; abstinent from alcohol for at least 6 months; free of substance abuse; free of active infections; without disabling psychiatric conditions; demonstrate medical compliance; have adequate social support and insurance; and be willing and able to make required lifestyle changes.alcohol abstinence ≥ 6 months

Requests are subject to medical necessity review if these criteria are not met or if transplanting institution selection criteria are absent.

Absolute and Relative Contraindications

Absolute contraindications to liver transplantation include active sepsis outside the biliary tract; situations where other effective medical or surgical options exist; and significant failure of other organ systems (excluding kidney, liver, or small bowel). Members meeting any of these conditions are considered ineligible for transplantation.

Post-Transplant Considerations

inv-28: Retransplantation

Retransplantation coverage ruleRetransplantation covered if initial transplant was performed for a covered indication

ApplicabilityApplies to retransplantation following a failed liver transplant

Review requirementSubject to medical necessity determination under same coverage criteria

Definitions and Background

Orthotopic liver transplantation is indicated for members with end-stage liver disease from multiple etiologies, including cholestatic diseases (e.g., biliary atresia, primary sclerosing cholangitis), hepatocellular diseases (e.g., alcoholic cirrhosis, chronic viral hepatitis with cirrhosis), vascular diseases (e.g., Budd-Chiari syndrome), metabolic disorders (e.g., Wilson's disease, alpha-1 antitrypsin deficiency), and selected malignancies confined to the liver that meet UNOS criteria. Selection requires documented medical necessity and resolution or control of active infections and other modifiable risks.

inv-21: Orthotopic liver transplantation

DefinitionLiver transplantation in the normal anatomical position (orthotopic)

Included graft typesCadaveric, reduced-size, living related, and split liver grafts

ScopeIndicated for end-stage liver disease when medical necessity criteria are met

inv-22: MELD score

Policy Background

Orthotopic liver transplantation refers to replacement of the liver in its normal anatomical position and is medically necessary for end-stage liver disease from a range of causes when patients meet the policy's selection criteria. Covered etiologies include cholestatic, hepatocellular, vascular, metabolic, and select malignant conditions limited to the liver; eligibility depends on meeting stated medical necessity and evaluation requirements.

Policy Summary

Payermediviewcurative

PolicyLiver Transplantation — Medical Necessity and Coverage Criteria

Policy CodePolicy MM-PNP-030

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review Date

Key ActionObtain prior authorization and document MELD score or UNOS Regional Review Board approval as applicable.

SourceLink

On This Page

inv-09: Hepato-pulmonary syndrome PaO2

PaO2 criterionPaO2 < 60 mm Hg

AaO2 gradient criterionAaO2 gradient > 20 mm Hg

PositioningMeasured in supine or standing position as specified

inv-10: Hepato-pulmonary syndrome pulmonary artery pressure

Mean pulmonary artery pressure thresholdmean pulmonary artery pressure < 35 mm Hg

Measurement methodBy catheterization

Associated conditionApplicable to porto-pulmonary hypertension within miscellaneous indications

Experimental/investigational items (e.g., OrganOx metra System; perioperative vasopressin or sorafenib; scaffold-based transplantation; transient elastography; UDCA; xenotransplantation) are subject to denial
Obtain authorization before proceeding with transplant-related services to allow review of experimental-designated interventions

Step Therapy

Retransplantation requires prior covered indication

Retransplantation requests require documentation that the initial transplant was performed for a covered indication; retransplantation is considered medically necessary only when that condition is met.

Retransplantation is covered only if the initial transplant was for a covered indication

Step Therapy

Step therapy: none specified

No step therapy requirements are specified in this policy for liver transplantation.

Documentation Required

Required clinical documentation to support authorization

Provide clinical documentation that supports the clinical decision and authorization criteria: documentation of MELD score, UNOS Regional Review Board approval when applicable, the transplant institution’s selection criteria, and tumor staging consistent with UNOS criteria for HCC or hepatoblastoma as indicated.

MELD score documentation when used to meet eligibility (MELD >10)
UNOS Regional Review Board approval documentation when applicable
Transplanting institution selection criteria when applicable
Tumor size/number and absence of extrahepatic spread per UNOS criteria for HCC or hepatoblastoma

Documentation Required

Documentation expectations: supply evaluation and procedure records

Supply standard transplant evaluation and procedural records as requested per the policy’s Documentation section; these records should include the evaluation that demonstrates eligibility criteria and any institutional selection criteria used.

Standard transplant evaluation records
Procedure and operative documentation upon request
Records demonstrating institution selection criteria or UNOS approval

Denial Risk

Assess behavioral, social, and medical suitability; denial risk if unmet

Ensure the candidate meets behavioral, social, and medical suitability criteria prior to authorization; requests may be denied for cancer outside the liver, active substance or alcohol abuse without at least 6 months’ abstinence, active infections, disabling psychiatric conditions, documented medical non‑compliance, inadequate social support or insurance, or other conditions making them unsuitable.

No cancer outside the liver
Alcohol abstinent for at least 6 months
No active substance abuse
No active infections
No disabling psychiatric conditions
Demonstrated medical compliance and adequate social support/insurance

Denial Risk

Absolute contraindications — denial risk

Do not authorize transplantation for members with absolute contraindications listed in the policy; transplantation is not medically necessary for members with active sepsis outside the biliary tract, when other effective medical/surgical options exist, or with significant organ system failure other than kidney, liver, or small bowel.

Active sepsis outside the biliary tract is an absolute contraindication
Other available effective medical or surgical treatments preclude transplant
Significant organ system failure (other than kidney, liver, or small bowel) precludes transplant

Denial Risk

Denial risk for experimental/investigational interventions

Requests for interventions explicitly listed as Experimental and Investigational in the policy may be denied; examples include the OrganOx metra System for liver preservation, perioperative vasopressin or sorafenib, scaffold-based transplantation approaches, transient elastography for acute rejection diagnosis, UDCA to prevent acute rejection, and xenotransplantation.

OrganOx metra System for transport/preservation
Perioperative vasopressin or sorafenib use
Scaffold-based transplantation (xeno‑organ/cell combinations)
Transient elastography for diagnosis of acute cellular rejection
UDCA as adjuvant to prevent acute cellular rejection
Xenotransplantation

Medical UM associates are responsible for understanding the procedure
Refer to the full policy for detailed documentation and evaluation instructions

Prior Authorization

Provide UNOS approval or transplant center selection criteria for eligibility

Confirm that members approved by the UNOS Regional Review Board or who meet the transplant institution’s selection criteria are eligible for consideration; ensure transplanting institution selection criteria are provided for children <12 and are taken into account for other ages when available.

UNOS Regional Review Board approval qualifies members for consideration
Transplant institution selection criteria determine eligibility for children <12 and inform review for others

DefinitionModel for End-stage Liver Disease (MELD) score used to assess severity of liver disease

Policy referenceMELD > 10 is a coverage consideration for adolescents ≥12 and adults

Role in eligibilityOne pathway to qualify for transplant evaluation in absence of UNOS approval or institution criteria