Fidelis Care pediatric liver transplant Coverage Update

Coverage Criteria for Pediatric Liver Transplant

Initial transplant coverage criteria

Covered when ALL of the following are met:

General eligibility

Primary indications (any one): End-stage liver disease due to qualifying diagnoses such as biliary atresia, cholestatic diseases, metabolic/genetic disorders, acute liver failure, hepatocellular or vascular disease, malignancies (nonmetastatic unresectable hepatoblastoma, selected hepatocellular carcinoma without extrahepatic disease), and miscellaneous conditions listed in policy.see subcriteria
Multiple specific subconditions and disease-specific thresholds are listed in policy.
Severity/impact criteria: At least one of: life expectancy <18 months without transplant; growth failure or reversible neurodevelopmental impairment; unacceptable quality of life; complications not responsive to medical therapy.clinical determination
Policy lists life expectancy <18 months as a stated criterion.

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Cholestatic disease criteria

Indication-specific nodes (examples extracted exactly as listed):

Biliary atresia and cholestatic diseases: Includes pre- and post-hepatoportoenterostomy criteria: pre-op infants with evidence of decompensated liver disease; post-hepatoportoenterostomy total bilirubin >6 mg/dL beyond 3 months or total bilirubin 2–6 mg/dL with unmanageable complications due to biliary cirrhosis or portal hypertension; familial intrahepatic cholestasis type 1 when partial external biliary diversion or ileal exclusion has failed or is not feasible; primary sclerosing cholangitis; Alagille syndrome.bilirubin thresholds as above

Policy enumerates multiple subcriteria.

Malignancy and metabolic indications

Malignancy and metabolic disease criteria:

Malignancy: Nonmetastatic unresectable malignancies (e.g., hepatoblastoma) and selected hepatocellular carcinoma without extrahepatic disease; hepatoblastoma with pulmonary metastases may be considered after chemotherapy with clear chest CT or after pulmonary resection with margins free of tumor.imaging and surgical/pathology findings

Policy specifies timing relative to chemotherapy and required clear imaging/surgical margins.

Metabolic/genetic disorders: Named metabolic conditions (e.g., alpha-1 antitrypsin deficiency, Wilson disease, severe urea cycle defects in infancy, Crigler-Najjar Type I, gestational alloimmune liver disease, hereditary tyrosinemia type 1, MDR-3 disease failing ursodeoxycholic acid, progressive disease on NTBC, glycogen storage diseases with poor metabolic control or complications, primary hyperoxaluria type 1, organic acidemias with uncontrollable hyperammonemia, inborn errors of bile acid synthesis refractory to medical therapy).disease-specific failure of medical therapy or complications

Policy includes many named disorders and subcriteria.

Explicit contraindications that may preclude coverage include active, uncontrolled infection with highly virulent and/or resistant microbes that are poorly controlled prior to transplant; malignancy with a high risk of recurrence or death (except malignancies the transplant could sufficiently address); recent cerebrovascular or cardiac events such as stroke, acute coronary syndrome, or myocardial infarction within 30 days; septic shock; and acute renal failure with low likelihood of recovery. The policy additionally lists severe, life‑threatening extrahepatic mitochondrial disease, Alpers syndrome, valproate‑associated liver failure, and Niemann‑Pick disease type C as exclusions in applicable circumstances.

Psychosocial and adherence‑related exclusions include progressive cognitive impairment; inability to adhere to the regimen necessary to preserve the transplant even with caregiver support; absence of an adequate or reliable social support system; and active substance use or dependence (including current tobacco/vaping or non‑prescribed marijuana and IV drug use) without convincing evidence of risk‑reduction behaviors, although conditional exceptions for urgent transplant timelines may be considered with a documented commitment to behavior reduction and monitoring.

When one or more of the contraindications listed in policy are present, the request for pediatric liver transplant is considered not medically necessary. Examples include uncontrolled active infection, malignancy with high recurrence risk, recent stroke/ACS/MI within 30 days, septic shock, acute renal failure with low likelihood of recovery, progressive cognitive impairment, inability to adhere to post‑transplant requirements despite caregiver support, lack of adequate social support, or active substance use without documented risk‑reduction.

Where applicable, the policy notes some conditional allowances (for example, urgent transplant timelines for active substance users with documented commitment to risk reduction), but these do not negate that the presence of listed contraindications ordinarily renders transplantation not medically necessary unless specific exceptions and monitoring plans meeting policy requirements are documented.

Candidate Eligibility

Candidate eligibility

Candidate must have end-stage liver disease from qualifying diagnoses and meet severity/impact criteria.

Candidate general requirements: Pediatric member (<=18) with life expectancy <18 months without transplant OR growth failure or reversible neurodevelopmental impairment OR unacceptable quality of life OR complications not responsive to medical therapy.clinical assessment

Also requires disease-specific qualifying diagnosis as enumerated in policy.

Contraindications and Exclusions

Absolute and important contraindications summarized from the policy include: active infection with highly virulent/resistant organisms that are not controlled before transplant; HIV infection with a detectable viral load unless all of the following are documented: absence of active AIDS‑defining opportunistic infection, a CD4 cell count ≥ 200 cells/mm3, and the member is currently on effective antiretroviral therapy (ART).

Renal function is an explicit cutoff: a glomerular filtration rate <30 mL/min/1.73m2 excludes candidacy unless the member is being considered for multiorgan transplant. Other medical exclusions include malignancy with high risk of recurrence or death (except malignancies that transplant can sufficiently address), recent stroke/acute coronary syndrome/MI within 30 days, septic shock, and acute renal failure with low likelihood of recovery.

Additional exclusions address severe systemic or neurologic conditions that limit survival or post‑transplant outcomes (for example progressive cognitive impairment, severe life‑threatening extrahepatic mitochondrial disease, and other severe uncontrolled medical conditions), and psychosocial/adherence contraindications such as inability to adhere to the required regimen even with caregiver support or absence of reliable social support. Active substance use or dependence is listed as a contraindication unless convincing evidence of risk‑reduction (or urgent timelines with commitment to behavior change) is provided.

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required for listed transplant procedure codes

Prior authorization is required for pediatric liver transplant procedures and related donor/implantation CPT/HCPCS codes; submit medical necessity documentation and the transplant center evaluation with the authorization request.

CPT: 47133, 47135, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147
HCPCS: S2152

Step Therapy

Therapy failure or unsuitability prerequisites

Approval requires documentation that conventional or specified medical therapies have failed or are not feasible for the condition (for example, failed diversion for familial intrahepatic cholestasis or complications unresponsive to medical management).

Example: failed partial external biliary diversion or ileal exclusion for familial intrahepatic cholestasis
Example: complications of cirrhosis or portal hypertension not responsive to medical therapy

Procedure and Billing Codes

Referenced CPT codesCPT

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	Donor hepatectomy (including cold preservation), from living donor; total left lobectomy (segments II, III and IV).
47142	Donor hepatectomy (including cold preservation), from living donor; total right lobectomy (segments V, VI, VII and VIII).
47143	Backbench standard preparation of cadaver donor whole liver to allotransplantation; without trisegment or lobe split graft prior.
47144	Backbench standard preparation of cadaver donor whole liver to allotransplantation; with trisegment split graft.
47145	Backbench preparation with split into left and right lobe grafts.
47146	Backbench reconstruction; venous anastomosis, each graft.
47147	Backbench reconstruction; arterial anastomosis, each graft.

Referenced HCPCS/CPT S-codeHCPCS

S2152

Solid organ(s), complete or segmental, procurement, transplantation, and related complications; global definition including perioperative care, drugs, supplies, hospitalization with outpatient follow-up, and pre- and post-transplant days of care.

inv-08: Total bilirubin (post-hepatoportoenterostomy) — threshold and interpretation

Threshold>6 mg/dL beyond 3 months after hepatoportoenterostomy OR total bilirubin persistently 2–6 mg/dL with unmanageable complications due to biliary cirrhosis or portal hypertension

ContextApplies to post-hepatoportoenterostomy patients as a disease-specific indication for pediatric liver transplant

Actionable interpretationConsider transplant evaluation when bilirubin >6 mg/dL at >3 months post-op, or when bilirubin 2–6 mg/dL is associated with complications not controlled by medical/surgical management

inv-09: Glomerular filtration rate — GFR <30 mL/min/1.73m2 exclusion threshold (unless multiorgan)

Exclusion thresholdGlomerular filtration rate (GFR) <30 mL/min/1.73 m2 excludes candidacy unless being considered for multiorgan transplant

Evaluation and Selection Requirements

Note

Evaluation requirements — multidisciplinary assessment per AASLD

A comprehensive multidisciplinary evaluation per AASLD is required and must document psychosocial, neurocognitive, developmental, and clinical readiness for transplant as part of the authorization package.

Evaluation should include specialists addressing psychosocial, neurocognitive, developmental, and complex clinical needs
Multidisciplinary team documentation should be submitted with the request

Note

Center requirements — multidisciplinary team and program standards

Evaluation must be performed by a multidisciplinary transplant team consistent with AASLD guidance; transplant center program standards or recognized transplant program processes should be evident in the submitted evaluation.

Documentation that a multidisciplinary transplant team performed the evaluation
Transplant center program processes or accreditation/recognized program standards referenced in the evaluation

Post-Transplant Services and Bundling

inv-20: perioperative, inpatient, outpatient follow-up, drugs, supplies — policy references global transplant-related service definitions

Global service definitionHCPCS S2152 defines solid organ procurement, transplantation, and related complications including drugs, supplies, hospitalization with outpatient follow-up and specified pre/posttransplant days

Bundled servicesPer policy, perioperative, inpatient, outpatient follow-up, drugs, and supplies are included within the global transplantation definition (S2152)

Billing implicationProviders should follow billing guidance for global/perioperative periods when submitting claims for transplant-related services

Background and Policy Scope

Pediatric end‑stage liver disease arises from a heterogeneous group of disorders. Common causes noted in the policy include biliary atresia and other cholestatic diseases, metabolic and genetic conditions (for example alpha‑1 antitrypsin deficiency, Wilson disease, glycogen storage disorders, and others), acute liver failure syndromes, vascular disorders, and selected malignancies such as hepatoblastoma or hepatocellular carcinoma when transplant is the appropriate therapy. The policy highlights that liver transplant is an effective treatment for these conditions and references allocation scoring systems in pediatrics such as PELD to prioritize candidates.

Definitions and Scoring Systems

inv-15: PELD — Pediatric End-stage Liver Disease score description and components

DefinitionPediatric End-stage Liver Disease (PELD) score for children uses total serum bilirubin, INR, height, weight, and albumin for allocation assessment

Age use notePELD was developed for children ≤12 years of age but is not ubiquitously utilized for allocation

ComponentsScore components: total bilirubin, INR, height, weight, and albumin

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Clinical Policy: Pediatric Liver Transplant