Liver Transplantation
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Defines medical necessity, covered indications, contraindications, experimental/investigational exclusions, CPT/HCPCS/ICD-10 codes related to liver transplantation, and background evidence. This part (1 of 5) includes policy criteria for candidate selection, covered diagnoses, retransplantation, contraindications, investigational items, and code lists.
No material clinical or coverage changes in this update.
Coverage Summary
This policy part is covered with criteria for orthotopic liver transplantation (OLT) and related procedures: it defines candidate selection (age-based rules using MELD/PELD thresholds, UNOS Regional Review Board or institutional selection criteria), lists covered diagnoses and examples of medically necessary indications (cholestatic, hepatocellular, vascular, metabolic, malignancy indications, fulminant hepatic failure, trauma, hepato-pulmonary syndrome), permits retransplantation when the initial transplant was for a covered indication, enumerates absolute contraindications, and identifies interventions considered experimental/investigational (e.g., bioartificial liver, MARS, machine perfusion modalities, xenotransplantation, everolimus). The part also contains the CPT/HCPCS/ICD-10 code lists that are covered when selection criteria are met and notes CPT/HCPCS items not covered. Criteria require documentation of MELD or PELD scores, UNOS or institutional approvals when applicable, and exclusion for absolute contraindications.
Medical-Necessity Criteria
Medical Necessity - Candidate Eligibility
Covered when ALL of the following are met:
Medical Necessity - Candidate Eligibility (top)
Age group and approvals
- Adolescents (>=12) and adults: Adolescents 12 years of age or older and adults: one of: MELD score greater than 10; OR approved for transplant by the UNOS Regional Review Board; OR meet the transplant institution's selection criteria>10 (MELD)
MELD/PELD definitions and guidance in Appendix
- Children <12: Children less than 12 years of age who meet the transplanting institution's selection criteriaPELD per institution
- Additional review for some cases: In absence of an institution's selection criteria, requests for liver transplantation are subject to medical necessity review for children, and for adolescents and adults with a MELD score of 10 or less who have not been approved by the UNOS Regional Review BoardMELD <= 10
Document MELD/PELD and UNOS/institutional approvals
From provider actions
Medically Necessary Indications (examples / not all-inclusive)
Orthotopic liver transplantation is medically necessary for ESLD due to any of the following when medical necessity criteria in Section I.A. are met:
Cholestatic diseases
- Biliary atresia
- Familial cholestatic syndromes
- Primary biliary cirrhosis
- PSC with secondary 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 HCC confined to liver: Primary hepatocellular carcinoma confined to the liver when ALL of the following are met: any lung metastases responsive to chemotherapy; member is not a candidate for subtotal liver resection; member meets UNOS criteria for tumor size and number; no identifiable extra-hepatic spread to lymph nodes, abdominal organs, bone or other sites; and no macrovascular involvementUNOS tumor size/number criteria
Consistent with UNOS guidelines
- Hepatoblastoma (<12): Hepatoblastomas in members <12 years when ALL of the following are met: member is not a candidate for subtotal liver resection; member meets UNOS criteria for tumor size and number; there is no identifiable extra-hepatic spread to lungs, abdominal organs, bone or other sites (note: spread to veins and lymph nodes does not disqualify)UNOS criteria
Pediatric note on venous/lymph node spread
- Epithelioid hemangioendotheliomas
- Intra-hepatic cholangiocarcinomas confined to liver: Intra-hepatic cholangiocarcinomas confined to the liver
- Large unresectable fibrolamellar HCCs: Large, unresectable fibrolamellar HCCs
- Metastatic neuroendocrine tumors with severe symptoms and metastases restricted to the liver, unresponsive to adjuvant therapy after aggressive surgical resection including excision of the primary lesion and reduction of hepatic metastases
Vascular diseases
- Budd-Chiari syndrome
- Veno-occlusive disease
Metabolic disorders
- Alpha-1-antitrypsin deficiency: 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 by catheterization < 35 mm Hgmean PAP < 35 mm Hg
Toxic and trauma
- Fulminant hepatic failure (toxic): Toxic reactions: Fulminant hepatic failure (e.g., mushroom poisoning, acetaminophen overdose)
- Trauma
- Hepato-pulmonary syndrome when ALL of the following selection criteria are met: arterial hypoxemia (PaO2 < 60 mm Hg or AaO2 gradient > 20 mm Hg in supine or standing position); chronic liver disease with non-cirrhotic portal hypertension; and intrapulmonary vascular dilatation indicated by contrast-enhanced echocardiography, technetium-99 macroaggregated albumin perfusion scan, or pulmonary angiographyPaO2 < 60 mm Hg; AaO2 > 20 mm Hg
Retransplantation
Absolute Contraindications (Not Medically Necessary)
Liver transplantation is considered not medically necessary for members with any of the following absolute contraindications:
- Active sepsis outside biliary tract: Active sepsis outside the biliary tract
- Other effective treatments available: Other effective medical treatments or surgical options are available
- Significant organ system failure: Presence of significant organ system failure other than kidney, liver or small bowel
- Extra-hepatic malignancy
- Severe cardiopulmonary disease
- Systemic sepsis
- Inability to comply with pharmacotherapy: Inability to comply with regular pharmacotherapy
Experimental and Investigational (Not Covered)
The following interventions are considered experimental and investigational due to unestablished safety/effectiveness and are not covered:
- Basiliximab for induction immunosuppression in individuals undergoing liver transplantation
Listed as investigational in policy
- Bioartificial liver transplantation
- Biomarkers for acute rejection: Biomarkers for diagnosis of acute allograft rejection including: acid labile nitroso-compounds (NOx), serum amyloid A protein, procalcitonin, peripheral blood T-cell activation, interleukin 2 (IL-2) receptor, guanylate-binding protein-2 mRNA, graft-derived cell-free DNA, pi-glutathione S-transferase, alpha-glutathione S-transferase and serum HLA class I soluble antigens
- Ectopic or auxiliary liver transplantation
- Everolimus to prevent rejection: Everolimus to prevent organ rejection after liver transplantation
NICE guidance not recommended
- Factor V Leiden and F2 testing for member scheduled to receive partial liver transplant for primary sclerosing cholangitis
- Hepatocyte transplantation: Hepatocellular (hepatocyte) transplantation
- Hypothermic machine perfusion for reduction of early allograft dysfunction and biliary complications after LT
Listed investigational in policy despite emerging evidence
- Liver transplantation for other malignancies: Liver transplantation for malignancies other than those listed as covered above
- LT for extra-hepatic hilar cholangiocarcinoma: Liver transplantation for the treatment of extra-hepatic hilar cholangiocarcinoma
- NGAL measurements: Measurements of plasma and urinary NGAL for predicting acute kidney injury following orthotopic liver transplantation
- MARS for PFIC: Molecular Adsorbent Recirculating System (MARS) for treatment of progressive familial intrahepatic cholestasis
- Normothermic machine perfusion of donor liver
- OrganOx metra system: OrganOx metra System for transportation and preservation of the liver prior to transplantation
Device-specific criteria listed in background
- Peri-operative vasopressin: Peri-operative use of vasopressin in liver transplantation
- Peri-operative sorafenib: Peri-operative use of sorafenib in liver transplantation
- Scaffold-based transplantation (combination of xeno-organ and cell transplantations)
- Transient elastography for ACR: Transient elastography for diagnosis of acute cellular rejection following liver transplantation
- Ursodeoxycholic acid to prevent ACR: Ursodeoxycholic acid (UDCA) as adjuvant to prevent acute cellular rejection after liver transplantation
- Xenotransplantation
Coding
| 47133 | Donor hepatectomy (including cold preservation), from cadaver donor. |
| 47135 | Liver allotransplantation; orthotopic; partial or whole, from cadaver or living donor, any age. |
| 47140 | Donor hepatectomy (including cold preservation), from living donor; left lateral segment only (segments II and III). |
| 47141 | Total left lobectomy (segments II, III and IV). |
| 47142 | Total right lobectomy (segments V, VI, VII and VIII). |
| 47143 | Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; without trisegment or lobe split. |
| 47144 | With trisegment split of whole liver graft into two partial liver grafts. |
| 47145 | With lobe split of whole liver graft into two partial liver grafts. |
| 47146 | Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; venous anastomosis, each. |
| 47147 | Arterial anastomosis, each. |
| no_specific_code | Molecular Adsorbent Recirculating System (MARS) - no specific code |
| no_specific_code | Normothermic machine perfusion of donor liver - no specific code |
| no_specific_code | Hypothermic machine perfusion - no specific code |
| no_specific_code | Scaffold-based transplantation - no specific code |
| no_specific_code | OrganOx metra System - no specific code |
| B16.0 | |
| B16.2 | |
| B18.0 | |
| B18.1 | |
| B19.11 | Acute hepatitis B with hepatic coma. |
| B16.1 | |
| B16.9 | |
| B19.10 | Acute hepatitis B without mention of hepatic coma. |
| B17.10 | Acute hepatitis C without hepatic coma. |
| B17.11 | Acute hepatitis C with hepatic coma. |
| A41.9 | Sepsis, unspecified organism. |
| C24.0 | Malignant neoplasm of extrahepatic bile duct. |
| Z76.82 | Awaiting organ transplant status [liver]. |
| Z94.4 | Liver transplantation status [not covered for the use of everolimus to prevent organ rejection]. |
Provider Actions & Requirements
Medical necessity review when institutional criteria absent or MELD <=10
Medical necessity review required when institutional selection criteria are not provided, or for adolescents and adults with a MELD score of 10 or less who have not been approved by the UNOS Regional Review Board.
Document MELD/PELD, UNOS approval, and institution selection criteria
Document MELD/PELD scores, UNOS Regional Review Board approval (when applicable), and that the member meets the transplanting institution's selection criteria.
Denial risk for absolute contraindications
Claims may be denied if any absolute contraindication to liver transplantation is present.
- Active sepsis outside the biliary tract
- Presence of significant organ system failure other than kidney, liver or small bowel
- Other absolute contraindications listed in the Contraindications section
Use background evidence to inform clinical decision-making
Use the background evidence in this policy to inform clinical decision-making and candidate selection. Document how applicable evidence influenced the evaluation and treatment plan.
Be aware of evidence limitations when applying policy
Be aware of the limitations of the evidence cited in this policy when making coverage determinations; document any instances where evidence limitations affected the clinical recommendation or decision.
Document preservation technique and ischemia times (machine perfusion evidence)
Consider available evidence regarding machine perfusion technologies when evaluating donor liver preservation strategies. Document the preservation technique used and relevant ischemia times in the medical record.
Document EBV viral load monitoring rationale
EBV viral load monitoring may be considered where clinically appropriate; document the rationale for testing and how results influenced management.
Reference policy dates and revision history in submissions
When submitting coverage determinations or prior authorization requests, reference this policy number (0596), the effective date (2002-03-05), and any applicable revision history or policy dates.
Background & Evidence Summary
Background rationale: liver transplantation is an effective therapy for fulminant hepatic failure and many chronic and metabolic liver diseases; MELD (adults) and PELD (children) scoring systems are used to prioritize candidates and identify urgency, with MELD scores <10 rarely requiring transplant and UNOS Regional Review Boards available to approve exceptions. Pediatric considerations include frequent use of reduced-size, split, and living-donor left-lobe grafts to address donor scarcity and size mismatch. Emerging and assessed technologies/interventions summarized include bioartificial liver systems and albumin-dialysis (MARS) with mixed survival impacts but improvements in bilirubin and encephalopathy; normothermic machine perfusion (NMP-L), hypothermic/sub-normothermic machine perfusion (HMP/SNMP) and hypothermic oxygenated perfusion (HOPE) with potential for better preservation and reduced biliary complications versus static cold storage but requiring more RCT data; OrganOx Metra and NRP strategies for extended preservation; peri-operative therapies evaluated include sorafenib (no clear survival benefit), ursodeoxycholic acid (no prevention of acute cellular rejection), peri-operative immuno-nutrition (some reduction in infections and shorter stays), vasopressin/terlipressin (limited renal benefit evidence), and immunosuppression agents including basiliximab and everolimus (basiliximab evidence limited/low-certainty; everolimus not recommended by NICE for prevention of rejection). Xenotransplantation, scaffold-based transplantation, hepatocyte transplantation and several perfusion/transport devices are considered investigational.
| Evidence Item | Key Finding |
|---|---|
| MARS randomized trials/meta-analyses | Meta-analyses and RCTs show MARS reduces bilirubin and improves hepatic encephalopathy but overall no consistent mortality benefit; some meta-analyses show no significant mortality reduction (RR 0.56; 95% CI 0.28–1.14) while others show benefit in acute liver failure (RR 0.61; 95% CI 0.38–0.97) |
| HepatAssist bioartificial liver RCT (HepatAssist) | HepatAssist RCT (n=171) showed no overall significant survival benefit; marginal survival benefit for fulminant/subfulminant hepatic failure (risk ratio = 0.56; p=0.048) |
| NMP-L early clinical studies | Early clinical NMP-L trials demonstrated feasibility and safety with potential improved function vs static cold storage; RCT data pending and larger randomized studies needed |
| Hypothermic machine perfusion (HMP) / HOPE RCT results | Randomized trial of hypothermic oxygenated perfusion (HOPE) vs SCS in DCD livers showed reduced non-anastomotic biliary strictures (6% vs 18%; RR 0.36) and lower early allograft dysfunction (26% vs 40%; RR 0.61) |
| Machine perfusion (HMP/SNMP) pre-clinical mitochondrial protection | Animal data and network analyses indicate HMP and SNMP provide superior preservation of graft ATP and mitochondrial protection compared with other methods |
| NLR pre-transplant meta-analysis | Elevated pre-transplant neutrophil-to-lymphocyte ratio associated with worse OS (HR 2.22), recurrence-free survival (HR 3.77), and disease-free survival (HR 2.51) after LT for HCC |
| PLR pre-transplant meta-analysis | High pre-transplant platelet-to-lymphocyte ratio (commonly cut-off ~150) associated with increased post-transplant HCC recurrence (OR 3.33) |
| Transient elastography (TE) performance post-LT | TE performed best for detecting recurrent fibrosis post-LT (summary OR 21.17); reported cut-offs varied widely (7.3–12.3 kPa); small studies suggest cut-offs >7.9–8.5 kPa may indicate graft damage |
| IL-2 receptor and other biomarkers for acute rejection | Systematic review identified multiple biomarkers; IL-2 receptor had highest reported sensitivity (89%) and specificity (81%), but none replace biopsy |
| Basiliximab induction evidence | Network meta-analysis of RCTs (25 trials, 3,271 subjects) found low-certainty evidence basiliximab may lower all-cause mortality (HR 0.53) and graft failure (HR 0.44) versus glucocorticoid induction, but evidence is uncertain and trials at risk of bias |
| OrganOx Metra device summary | OrganOx metra is a transportable normothermic perfusion device supporting donor livers (DBD or DCD ≤40 y, functional warm ischemia ≤20 min, macro-steatosis ≤15%) and intended to sustain livers for total preservation times up to ~12 hours (device supports up to 24 h) |
Definitions & Thresholds
Definitions:
MELD — Model for End-Stage Liver Disease; numerical scale (6–40) predicting 3-month mortality using bilirubin, prothrombin time and creatinine.
PELD — Pediatric End-stage Liver Disease scoring system for candidates under age 12, incorporating bilirubin, prothrombin time, albumin, growth failure, and age <1 year.
MARS — Molecular Adsorbent Recirculating System; an extracorporeal albumin dialysis device for liver support.
NMP-L — Normothermic Machine Perfusion of the Liver; organ preservation technique at physiologic temperature enabling viability assessment.
TE — Transient Elastography; noninvasive measurement of liver stiffness (reported in kPa).
NLR — Neutrophil-to-Lymphocyte Ratio; a pre-operative prognostic marker.
PLR — Platelet-to-Lymphocyte Ratio; a pre-operative prognostic marker (cut-off commonly reported as 150).
HMP — Hypothermic Machine Perfusion.
SNMP — Sub-normothermic Machine Perfusion.
NMP — Normothermic Machine Perfusion.
OLT — Orthotopic Liver Transplantation.
PE — Pulmonary Embolism.
PVT — Portal Vein Thrombosis.
DBD — Donor after Brain Death.
DCD — Donor after Circulatory Death.
SCS — Static Cold Storage.
HOPE — Hypothermic Oxygenated Perfusion.
NRP — Normothermic Regional Perfusion.
NAS — Non-anastomotic Biliary Strictures.
PTLD — Post-Transplant Lymphoproliferative Disease.
Revision History
Policy effective date: 2002-03-05.
Policy last reviewed on 2023-08-09.
Next scheduled policy review on 2024-06-27.
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