ModifiedCignaPolicy 0355

Liver and Liver-Kidney Transplantation

Cigna's coverage criteria and coding guidance for liver transplantation, liver retransplantation, and simultaneous liver-kidney (SLK) transplantation, including transplant waitlisting and oncology MELD exception alignment; applies to members under Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyLiver and Liver-Kidney Transplantation

Policy CodePolicy 0355

Change TypeMaterial revisions to disease-specific statements and contraindications

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation (including MELD/PELD exception materials and oncology imaging/labs) to support transplant listing or procedure.

SourceLink

POLICY UPDATE CHANGES

Added policy statements regarding history of malignancy.

Added a disclaimer statement for transplant wait listing.

Added policy statements for intrahepatic cholangiocarcinoma, colorectal liver metastases (CRLM), hepatic epithelioid hemangioendothelioma (HEHE), hepatic adenomas, cystic fibrosis, and familial amyloid polyneuropathy (FAP).

Revised policy statements for hepatocellular carcinoma (HCC), metabolic disease, perihilar or hilar cholangiocarcinoma, and neuroendocrine tumors.

Revised the policy statement for liver retransplantation specific to hepatic artery thrombosis.

Revised the liver transplant contraindications policy statement.

Revised policy statement for mechanical preservation machines.

11,458Liver transplants (2024)

≤1000AFP threshold (T2 HCC)

2 yrs

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Common wait time for several cancers

Metastatic diseaseNot eligible

10+New disease-specific statements

Coverage Criteria for Liver, Retransplantation, and SLK

Primary Liver Transplantation - Indications

Covered when ANY of the following indications are met:

Primary Indications: End-stage liver failure.ANY

Hepatocellular carcinoma (HCC): HCC meeting T2 criteria, including patients who presented with stage T2 treated by locoregional therapy or resected but who developed T1 or T2 recurrence; or HCC downstaged to T2 with no extrahepatic disease, no macrovascular invasion, and AFP ≤1000 ng/mL.ANY

Hepatoblastoma confined to the liver.ANY

Metabolic diseases: Selected metabolic diseases (e.g., urea cycle disorder or organic acidemia).ANY

Unresectable perihilar/hilar cholangiocarcinoma: Unresectable perihilar or hilar cholangiocarcinoma when BOTH neoadjuvant therapy has been administered before transplantation AND there is absence of regional hepatic lymph node metastases, intrahepatic metastases, or extrahepatic disease.ANY

Unresectable solitary iCCA or mixed HCC-iCCA: Unresectable solitary intrahepatic cholangiocarcinoma or mixed HCC-iCCA that is ≤3 cm and demonstrates 6 months of tumor stability after locoregional or systemic therapy.ANY

Neuroendocrine tumors (GEP origin): GEP neuroendocrine tumors with resection of the primary and no evidence of extrahepatic recurrence for ≥6 months, and liver-only bi-lobar metastases not amenable to resection.ANY

Colorectal liver metastases (CRLM): CRLM when ALL of the following are met: primary colorectal cancer resected with negative margins and no local recurrence on colonoscopy within 12 months; no extrahepatic disease on required imaging; receiving or received first-line chemotherapy/immunotherapy; relapse after resection or unresectable metastases; no hepatic lesion >10 cm before treatment; stability or regression of disease for ≥6 months with systemic and/or locoregional therapy.ANY

HEHE: Unresectable hepatic epithelioid hemangioendothelioma (HEHE).ANY

Hepatic adenomas meeting specific criteria including presence with glycogen storage disease, unresectable β-catenin positive adenoma, or adenomas that are unresectable, progressive, or complicated (eg, hemorrhage or malignant transformation) and unresponsive to medical management.ANY

Cystic fibrosis with genetic confirmation AND FEV1 < 40% predicted within 30 days prior to initial MELD exception submission.ANY

Familial amyloid polyneuropathy (FAP): FAP with active registration on that hospital's heart transplant waiting list OR echocardiogram within 30 days showing EF >40%, able to ambulate without assistance, presence of TTR gene mutation, and biopsy-proven amyloid.ANY

Hepatopulmonary syndrome (HPS): HPS with ascites/varices/splenomegaly/thrombocytopenia, demonstration of an intrapulmonary shunt by contrast echocardiogram or lung scan, PaO2 < 60 mmHg on room air within 30 days prior to MELD exception submission, and absence of clinically significant primary pulmonary disease.ANY

Portopulmonary hypertension with documented initial heart catheterization showing MPAP ≥35 mmHg and PVR ≥240 dynes·sec/cm5 (≥3 WU) from same test date, assessment excluding other causes, documentation of portal hypertension, documented treatment, and post-treatment catheterization within 90 days meeting specified post-treatment MPAP/PVR criteria.ANY

Primary hyperoxaluria when on the kidney waiting list at that center, AGT deficiency proven by biopsy or genetic testing, and GFR ≤25 mL/min on two occasions at least 42 days apart.ANY

Liver Retransplantation - Indications

Covered when ALL of the following are met:

Retransplant Indications: Primary graft failure.ANY

Retransplant Indications: Severe rejection.ANY

Retransplant Indications: Recurrence of the disease which prompted the initial liver transplantation.ANY

Hepatic artery thrombosis (adult) - early: Adult hepatic artery thrombosis within 7 days of transplant with AST ≥3000 U/L AND at least ONE of: INR ≥2.5, arterial pH ≤7.30, venous pH ≤7.25, or lactate ≥4 mmol/L.

Simultaneous Liver-Kidney (SLK) Transplantation

Covered for individuals 64 years who meet liver transplant criteria and ANY of the following kidney-related indications:

CKD pathway: Chronic kidney disease with measured or calculated GFR ≤60 mL/min for >90 consecutive days AND at least ONE of: receiving regularly administered dialysis as ESRD; most recent measured/calculated CrCl or GFR ≤30 mL/min at time of registration on kidney waiting list; or measured/calculated CrCl or GFR ≤30 mL/min on a date after registration.ANY

Sustained AKI pathway: Sustained acute kidney injury with, for the previous 6 weeks, at least ONE of: dialysis at least once every 7 days OR measured/calculated CrCl or GFR consistently ≤25 mL/min (and eligibility must be confirmed at least once every 7 days for the last 6 weeks).ANY

Specific diagnoses: Specific metabolic/rare diagnoses including hyperoxaluria, atypical HUS from factor H or I mutations, familial non-neuropathic systemic amyloidosis, or methylmalonic aciduria.

History of Malignancy

Covered when ALL of the following are met:

Malignancy Clearance: Candidate meets transplant criteria AND has oncology clearance per published guidelines AND does not have listed contraindications to transplant.ALL

Standardized MELD/PELD exception and allocation criteria

Covered when meeting OPTN Policy 9.5 standardized MELD/PELD exception criteria and reporting requirements:

T2 HCC standardized exception: Candidate meets T2 lesion definition AND has AFP ≤1000 ng/mL.AFP ≤1000 ng/mL

T2 definition: one class 5 lesion ≥2 cm and ≤5 cm OR two to three class 5 lesions each ≥1 cm and ≤3 cm

Downstaging pathway: Candidate with lesions meeting OPTN downstaging inclusion criteria who complete local-regional therapy and on post-treatment dynamic-contrast CT or MRI have viable lesions meeting T2 stage are eligible for standardized exception.Lesion size/number/total diameter per Policy 9.5.I.iii

Downstaging must be demonstrated by dynamic-contrast enhanced CT or MRI after therapy; candidates not initially meeting inclusion criteria who are later downstaged must be referred to the NLRB.

AFP >1000 handling:

Retransplantation and donor health

Coverage considerations for retransplantation and donor suitability:

Retransplantation consideration: Retransplantation may be considered for carefully selected patients with graft loss when an improvement in survival is expected; avoid in emergency settings or when chance of success is minimal.clinical judgment

Retransplantation for recurrent HCV is controversial due to decreased survival.

Donor exclusion factors: Donors with persistent, recurrent, or untreated HCV infection; HBsAg-positive donors; ongoing alcohol abuse; active systemic illness; or malignancy are generally excluded from living-donor liver transplant donation.presence of listed conditions

These donor factors negatively affect recipient outcomes.

Prostate cancer

Prostate cancer — transplant candidacy recommendations based on risk strata

Low-risk/localized: If on surveillance: no wait time required. If treatment initiated and nomogram predicts cancer-specific death over next 15 years <10%: no wait time.nomogram predicted cancer-specific death <10% over 15 years

Low-volume intermediate risk defined by PSA >10 ng/mL or Gleason 7 (grade group 2 or 3).

High-volume intermediate/high/very high risk: If treatment initiated and nomogram predicts cancer-specific death over next 15 years <10%: no wait time; otherwise consider treatment and appropriate interval based on clinical judgment.PSA >20 ng/mL or high-volume Gleason 7 or Gleason 8-10 or T3

Survival and metastatic risk vary (20-70% over 15 years).

Metastatic disease: Metastatic castration-sensitive disease: may be considered if stable for 2 years with prolonged estimated life expectancy. Metastatic castration-resistant disease: not a transplant candidate.

Bladder cancer

Bladder cancer — timing based on NMIBC/MIBC risk strata and treatment

NMIBC low or intermediate risk: Recommended interval to transplant: 6 months for NMIBC low- or intermediate-risk disease.NMIBC low or intermediate risk per definitions

Low risk: solitary <3 cm, low-grade, Ta tumor, no CIS; intermediate and high-risk definitions per source.

High-risk NMIBC: Recommended interval to transplant: 2 years for high-risk NMIBC.High-risk NMIBC criteria (eg, CIS, high-grade T1, multifocal high-grade)

Higher progression rates justify longer interval.

MIBC post-radical cystectomy: Recommended interval to transplant: 2 years after radical cystectomy for MIBC.MIBC post-radical cystectomy

Cutaneous squamous cell carcinoma, Merkel cell carcinoma, and melanoma

Skin cancers (cutaneous SCC, Merkel cell carcinoma, melanoma) — recommended treatments and wait times by risk/stage

Low-risk cutaneous SCC: Appropriate pretransplant treatment: surgical excision with clear margins or Mohs micrographic surgery. Wait time: no delay necessary.Low-risk SCC

High-risk cutaneous SCC (without perineural invasion): Appropriate treatment: surgical excision with clear margins or Mohs; Wait time: 2 years. If perineural invasion or other high-risk features, consider adjuvant radiation and wait 2-3 years.High-risk SCC

High-risk SCC with nodal disease: Appropriate treatment: excision plus lymph node dissection and adjuvant radiation therapy; Wait time: 5 years for local nodal metastatic disease. Distant metastasis: not eligible.Local nodal metastatic SCC

Hematologic malignancies

Hematologic malignancies — event-free/progression-free milestones and recommended intervals

Aggressive lymphomas and Hodgkin lymphoma: Recommended interval to transplant: generally 2 years after achieving EFS24/PFS24 for DLBCL, Burkitt lymphoma, peripheral T-cell lymphoma, and Hodgkin lymphoma, based on disease-specific outcomes.EFS24/PFS24 achieved

Follicular lymphoma: Recommended interval to transplant: 2 years after achieving EFS24.EFS24 achieved

Chronic lymphocytic leukemia (CLL): Recommended interval to transplant: 2-3 years after treatment if in remission and without high-risk CLL-IPI (>4); consider candidacy if stable.Remission and CLL-IPI ≤4

Myeloma and amyloidosis

Myeloma and amyloidosis — criteria for safe transplant candidacy (figure referenced)

Myeloma/amyloidosis: Refer to the figure-based criteria summarizing dFLC thresholds and disease control metrics (eg, difference between involved and uninvolved serum free light chains) to determine safe solid organ transplant candidacy.dFLC and disease control per referenced figure

See source figure for specific numeric thresholds and milestones.

Donor exclusion criteria identify conditions that render a potential living donor unacceptable. Donors with ongoing alcohol abuse, active malignancy (except non‑melanotic skin cancer), or persistent, recurrent, or untreated infections (including hepatitis A, B, C, or HIV) are considered contraindicated for donation. Additionally, donors with active systemic illness or serious comorbidities that would be expected to substantially negatively impact transplant outcomes are excluded.

Candidates who undergo downstaging must meet OPTN Policy 9.5 downstaging inclusion criteria prior to local‑regional therapy and then complete therapy with post‑treatment dynamic contrast CT or MRI demonstrating viable lesions that meet the T2 lesion requirements to qualify for a standardized MELD/PELD exception. If lesions did not initially meet downstaging protocol inclusion criteria but are later downstaged to T2, the candidate is not automatically eligible and must be referred to the National Liver Review Board (NLRB) for consideration.

Any candidate with distant metastatic disease (for example, distant metastatic cutaneous squamous cell carcinoma or Merkel cell carcinoma) or with metastatic castration‑resistant prostate cancer is excluded from solid organ transplant candidacy and is not eligible for transplantation; oncology referral is recommended prior to considering transplant in patients with distant metastasis.

Revision notes indicate that the policy statements for contraindications were revised; specific operational changes include updates to retransplantation guidance (for example, hepatic artery thrombosis) and expanded disease‑specific statements. Where revised contraindications alter listing decisions, programs should follow the full policy text and NLRB guidance for implementation and documentation.

Liver transplantation is not medically necessary for individuals with ongoing alcohol abuse, for those with specified advanced or recurrent malignancies listed in the policy (including many stage IV or recurrent cancers), for patients with persistent, recurrent, or unsuccessfully treated major/systemic infections, or for individuals with active systemic illness or serious comorbidities expected to substantially worsen transplant outcomes.

Retransplantation may be considered for carefully selected patients with graft loss when improvement in survival is expected, but retransplantation should be used with discretion in emergency settings and generally avoided when the likelihood of success is minimal. Retransplantation for recurrent HCV is controversial because several studies show reduced patient and graft survival; programs should consider these outcome data in candidate selection.

Any candidate with stage III or stage IV melanoma is not eligible for transplantation. For melanoma with lower stages (in situ, stage Ia, Ib/II/IIb–IIc), the policy provides specific treatment and recommended wait intervals, but any stage III/IV disease constitutes a contraindication to listing.

This segment does not list an exhaustive catalog of not medically necessary (NMN) conditions but notes that the liver transplant contraindications statement was revised; explicit NMN conditions (beyond those already summarized such as ongoing alcohol abuse and advanced/recurrent malignancy) are detailed elsewhere in the full policy and appendices referenced in the revision notes.

Coding and Clinical Thresholds

Covered CPT/S codes for donor and transplant proceduresCPTCovered

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 graft prior to allotransplantation; without trisegment or lobe split.
47144	Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; with trisegment split into 2 partial grafts.
47145	Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation; with lobe split into 2 partial grafts.
47146	Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; venous anastomosis, each.
47147	Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; arterial anastomosis, each.

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Pulmonary/hemodynamic thresholds for HPS and portopulmonary hypertension

Hepatopulmonary syndrome (HPS) — arterial oxygenationPaO2 < 60 mmHg on room air within 30 days prior to initial MELD exception request

HPS — diagnostic shunt requirementDemonstrated intrapulmonary shunt by contrast echocardiogram or lung scan

Portopulmonary hypertension — initial hemodynamicsInitial right-heart catheterization with MPAP ≥35 mmHg AND PVR ≥240 dynes·sec/cm5 (≥3 Wood units) from same test date

Portopulmonary hypertension — post-treatment response (option 1)Post-treatment MPAP < 35 mmHg AND post-treatment PVR < 400 dynes·sec/cm5 (<5 WU) from same test date

Portopulmonary hypertension — post-treatment response (option 2)Post-treatment MPAP ≥35 and <45 mmHg AND post-treatment PVR < 240 dynes·sec/cm5 (<3 WU) from same test date

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for liver transplantation, liver retransplantation, and simultaneous liver‑kidney (SLK) transplantation. Requests must document that the candidate meets the policy's clinical criteria (including applicable MELD/PELD exception rules, tumor staging and imaging, and disease‑specific stability or response requirements) and include oncology clearance when there is a history of malignancy. Programs should submit supporting documentation described below at the time of the initial prior authorization request.

Prior authorization required for liver transplant, liver retransplant, and SLK when meeting policy criteria
Include documentation of MELD/PELD exception eligibility or NLRB review when applicable
Oncology clearance required for candidates with prior malignancy (see references and Appendix)

Prior Authorization

Prior Authorization — Candidates with Prior Malignancy

For candidates with a prior history of malignancy, prior authorization must include documentation of the cancer type, treatment history, disease stage, response to therapy, surveillance data, and the recommended transplant‑specific waiting interval or clearance per published guidance. The transplant program must attest that the candidate meets the policy's malignancy‑specific eligibility and waiting‑time recommendations and that there are no active contraindications to transplantation.

Waitlist and Candidate Eligibility

Waitlist criteria

Waitlist and candidate eligibility

Waitlist Oncology Alignment: Transplant waitlisting for liver oncology diagnoses must meet National Liver Review Board (NLRB) Adult Transplant Oncology Review Board guidelines (2/27/2025).ANY

Liver transplant candidate exception criteria (oncology-related)

OPTN Policy 9.5 standardized exception eligibility for liver transplant candidates with hepatic neoplasms:

T2 HCC eligibility: Candidate has T2 HCC lesion(s) per OPTN definition AND AFP ≤1000 ng/mL.T2 lesion size/number and AFP ≤1000 ng/mL

Contraindications for Transplant and Donor Exclusions

General contraindications to liver transplantation include ongoing alcohol abuse; specified advanced or recurrent malignancies (including metastatic disease such as distant metastatic cutaneous SCC, Merkel cell carcinoma, and malignant melanoma stage III/IV); persistent, recurrent, or unsuccessfully treated major or systemic infections; and active systemic illness or serious comorbidities expected to substantially negatively impact transplant completion or outcome. These donor‑ or candidate‑level contraindications should be documented and considered in listing and donation decisions.

Donor contraindications for living‑donor liver transplantation include persistent, recurrent, or untreated infections (notably HCV), donors who are hepatitis B surface antigen (HBsAg) positive, ongoing alcohol abuse, active systemic illness, or active malignancy (except non‑melanotic skin cancer). Donor candidates with these conditions are generally considered unacceptable for donation due to the risk of harm to the donor and potential negative effects on recipient outcomes.

Particular caution is advised for retransplantation in patients with recurrent HCV because outcomes and survival may be worse; retransplantation decisions should be individualized and avoided when the chance of success is minimal. Candidate contraindications for retransplantation include settings where expected survival benefit is low or when the procedure would be performed emergently with poor prognosis.

Metastatic castration‑resistant prostate cancer is explicitly listed as a contraindication to solid organ transplantation. Likewise, distant metastatic skin cancers and any stage III or IV melanoma are contraindications to transplantation and render the candidate ineligible until managed according to oncology guidance.

Pretransplant Evaluation and Testing Requirements

Note

Complete required imaging and physiologic testing per indication

Pretransplant evaluation must include indicated imaging, pulmonary testing, and other modality‑specific assessments within the intervals specified for oncology exceptions and physiologic indications.

Examples: CT/MRI/PET within one month for colorectal liver metastases; PaO2 measurement for hepatopulmonary syndrome; right‑heart catheterization hemodynamics for portopulmonary hypertension.

Note

Obtain post‑treatment dynamic CT/MRI to document downstaging

Downstaging candidates must have post‑local‑regional therapy dynamic‑contrast enhanced CT or MRI that demonstrates viable lesions meeting T2 criteria to qualify for standardized MELD/PELD exceptions.

Documentation Required

Document renal function and dialysis confirmation for liver‑kidney allocation

Transplant Program and Review Board Responsibilities

Note

Submit MELD/PELD exception requests to the NLRB and exercise center oversight

Transplant programs are expected to submit MELD/PELD exception requests to the NLRB when appropriate and the transplant center medical director should exercise clinical oversight in individual coverage determinations.

Follow OPTN/NLRB processes and reporting requirements for exception requests.

Note

Adhere to OPTN/NLRB reporting and documentation protocols

Transplant programs and review boards must follow OPTN/NLRB processes and reporting/documentation protocols when managing exception requests and organ allocation decisions.

Note

Follow OPTN/NLRB processes for exception review and reporting

Transplant programs and review boards must operate under OPTN/NLRB processes and follow reporting/documentation protocols (consolidated guidance repeated in the policy).

Post-Transplant Procedures, Surveillance, and Coverage Notes

Transplant procedures and related global services (medically necessary codes)

Primary transplant procedure codes47135 — Liver allotransplantation, orthotopic, partial or whole (cadaver or living donor)

Donor hepatectomy codes (living donor)47140, 47141, 47142 — Living donor hepatectomy (left lateral, total left lobectomy, total right lobectomy)

Backbench graft preparation and reconstruction47143, 47144, 47145, 47146, 47147 — Backbench preparation, splits, and vessel reconstructions

Global/transplant procurement bundleS2152 — Solid organ(s) procurement, transplantation, and related complications (global definition including drugs, supplies, hospitalization and follow-up)

Transplant for cholangiocarcinoma and biliary tract cancers (selection/trial context)

Cholangiocarcinoma transplant consideration

Background and Policy Scope

Liver transplantation is indicated to treat irreversible hepatic failure and selected liver cancers and metabolic disorders; MELD/PELD scoring is used to estimate short‑term mortality and prioritize candidates. The policy aligns transplant waitlisting and MELD/PELD exception processes with OPTN/Policy 9.5 and NLRB guidance, requiring appropriate imaging, laboratory, and documentation for oncology‑related exceptions and emphasizing donor health and evaluation considerations.

Key Definitions and Abbreviations

MELD/PELD — purpose and exception process

Purpose of MELD/PELDMELD and PELD are scoring systems estimating short-term mortality to prioritize liver transplant candidates (3‑month mortality estimate)

Exception processTransplant programs may submit MELD/PELD exception requests to the National Liver Review Board (NLRB) when a candidate's score does not reflect medical urgency

Allocation resourcesOPTN allocation calculators and policy guidance (Policy 9 and NLRB updates) are referenced for allocation and exception determinations

Living-donor liver transplantation (LDLT) — definition and benefits

Living-donor liver transplantation (LDLT) — definitionTransplantation using a liver segment from a living donor; grafts may be whole, reduced, or segmental depending on donor/recipient

LDLT — recipient benefits

Policy Changes and Revision Notes

2025-10-15focused review - content addedLatest

Added policy statements regarding history of malignancy (document-level update to candidate disease-specific guidance).

2025-04-15annual review - additions and revisions

Added disclaimer for transplant wait listing and new disease-specific policy statements for intrahepatic cholangiocarcinoma, colorectal liver metastases (CRLM), hepatic epithelioid hemangioendothelioma (HEHE), hepatic adenomas, cystic fibrosis, and familial amyloid polyneuropathy (FAP); also added hepatopulmonary syndrome, portopulmonary hypertension, and primary hyperoxaluria statements and revised multiple disease-specific policy statements and retransplantation guidance for hepatic artery thrombosis.

Policy Summary

PayerCigna

PolicyLiver and Liver-Kidney Transplantation

Policy CodePolicy 0355

Change TypeMaterial revisions to disease-specific statements and contraindications

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation (including MELD/PELD exception materials and oncology imaging/labs) to support transplant listing or procedure.

SourceLink

On This Page

Hepatic artery thrombosis (adult/pediatric) - later: Adult hepatic artery thrombosis within 14 days of transplant (that does not meet status 1A criteria) or pediatric hepatic artery thrombosis within 14 days of transplant as specified.ANY

Retransplant candidacy requirement: Individual is considered to have a significant chance of success and still meets eligibility criteria for primary transplantation; retransplantation to be considered with clinical judgment and avoided in emergency settings or when little chance of success exists.ALL

Documentation requirement: Transplant nephrologist must confirm CKD/dialysis/CrCl or GFR values or metabolic disease diagnosis and the program must report and document this in the candidate's medical record per allocation policy.GFR/CrCl thresholds per Policy 9.5

Candidate with prior AFP >1000 ng/mL must follow Policy 9.5.I.iv: if AFP falls <500 ng/mL after treatment, candidate may be eligible for standardized exception; if AFP remains ≥500 ng/mL after therapy, refer to the NLRB.

Post-treatment AFP <500 ng/mL to qualify for standardized exception

Candidates with AFP ≥500 ng/mL after therapy must be referred to the NLRB.

Liver-kidney allocation documentation: For combined liver-kidney allocation, transplant nephrologist confirmation of CKD/dialysis/CrCl or GFR values or qualifying metabolic disease is required and must be reported and documented in the candidate's record per OPTN Policy 9.5.GFR/CrCl thresholds and dialysis frequency per Policy 9.5

If eligibility is not confirmed at required intervals, candidate is not eligible to receive liver and kidney from same donor.

Stable disease 2 years required for castration-sensitive

Median survival castration-sensitive ~5-6 years; castration-resistant ~2-3 years.

2-year local recurrence 25-37%.

MIBC post-chemoradiation: MIBC treated with chemoradiation: not an SOT candidate.Post-chemoradiation MIBC

Higher recurrence risk; not eligible for transplantation.

Melanoma in situ: Appropriate treatment: wide local excision; Wait time: no delay necessary but follow-up posttransplant every 3 months.In situ melanoma

Melanoma stage-based: Stage Ia: wide local excision; Wait time: 2 years. Stage Ib/II/IIa-IIc: wide local excision ± sentinel lymph node biopsy; Wait time: 2-5 years depending on stage (eg, IIb/IIc = 5 years). Any stage III/IV melanoma: not eligible for transplantation.Melanoma stage

Monoclonal B cell lymphocytosis (MBL): No wait time required for MBL.MBL diagnosis

GFR/CrCl thresholds for SLK

Chronic kidney disease (CKD) — prolonged reduced GFRMeasured or calculated GFR ≤ 60 mL/min for >90 consecutive days (plus one of the listed additional criteria)

Registration/registration-time renal thresholdMost recent measured or calculated CrCl or GFR ≤ 30 mL/min at time of kidney waiting list registration

Post-registration renal thresholdMeasured or calculated CrCl or GFR ≤ 30 mL/min on a date after registration

Sustained acute kidney injury (AKI) — dialysis criterionReceiving dialysis at least once every 7 days for the previous 6 weeks

Sustained AKI — measured renal function criterionConsistently measured or calculated CrCl or GFR ≤ 25 mL/min for the previous 6 weeks

Alpha-fetoprotein (AFP) thresholds for standardized MELD/PELD exceptions

Initial T2 standardized exception AFP thresholdAlpha-fetoprotein (AFP) ≤ 1000 ng/mL required for eligibility for a standardized MELD/PELD exception for T2 HCC

Prior AFP >1000 — post-treatment clearance requirementIf AFP was previously >1000 ng/mL, AFP must fall below 500 ng/mL after local-regional therapy to qualify for a standardized exception

AFP ≥500 post-treatment handlingCandidates with AFP ≥ 500 ng/mL after therapy must be referred to the National Liver Review Board (NLRB) for consideration

Provide oncology clearance consistent with published guidelines and the policy Appendix
Document treatment dates, pathology (including markers such as PSA, Gleason score for prostate cancer; NMIBC/MIBC classification for bladder cancer; staging and SLN results for skin cancers; EFS/PFS where applicable)
State the recommended wait time applied and supporting evidence (surveillance vs. post‑treatment intervals)

Prior Authorization

Address New/Updated Disease‑Specific Criteria in Prior Authorization

Prior authorization submissions must address any updated disease‑specific criteria reflected in this policy (for example, revised HCC criteria, downstaging rules, or inclusion of new tumor types). If the policy was updated after the candidate's initial evaluation, include evidence that the candidate meets the revised criteria or an explanation of why an exception or NLRB referral is being requested.

If relying on downstaging, submit post‑treatment dynamic contrast CT or MRI showing viable lesions meet T2 criteria
Confirm completion and results of recommended local‑regional or systemic therapies where required
If criteria changed since initial evaluation, document conformity to the updated policy or request NLRB consideration

Billing Rule

Billing and Coding

Claims for services that are not accompanied by covered code(s) under this Coverage Policy will be denied as not covered. When submitting prior authorization and subsequent claims, use the most appropriate and current procedure and diagnosis codes that reflect covered services per the policy.

Prior authorization and claims must include covered CPT/ICD‑10 codes consistent with the policy
Services without covered codes under this policy will be denied

Denial Risk

Risk from Not Meeting Updated Candidate Criteria

Failure to meet updated candidate criteria, provide required documentation, or obtain required prior authorization may result in denial of coverage for transplant listing, exclusion from MELD/PELD exceptions, and/or claim denial. Providers should confirm program eligibility against the current policy and NLRB requirements before listing or scheduling transplantation.

Not meeting updated candidate criteria can affect eligibility for wait listing or MELD/PELD exceptions
Incomplete documentation or missing oncology clearance may lead to denial of prior authorization or claims

Documentation Required

Reporting and Documentation for Liver‑Kidney Allocation

For simultaneous liver‑kidney (SLK) allocation and MELD/PELD exception reporting, the transplant nephrologist and program must document confirmatory renal testing and serial measurements as required by OPTN/Policy 9.5 and Table 9‑17. Documentation must include GFR/CrCl values, dialysis frequency (if applicable), and the nephrologist's confirmation of diagnosis and eligibility.

Report and document measured or calculated GFR/CrCl values and dialysis dates/frequency per OPTN requirements
Transplant nephrologist must confirm diagnoses used for SLK allocation and document findings in the medical record

Documentation Required

Required Cancer Documentation

Required cancer documentation must be included with prior authorization and listing requests. Submit pathology reports, imaging (CT/MRI/PET), tumor markers (e.g., AFP, PSA), staging details, treatment summaries (including dates and responses), and oncology clearance statements. For downstaged HCC, include post‑treatment dynamic contrast CT or MRI demonstrating lesion response to meet T2 criteria.

Pathology and operative reports, including tumor type and relevant markers (PSA, Gleason, AFP, etc.)
Imaging reports (chest/abdomen/pelvis CT or MRI and PET when required) and post‑treatment imaging for downstaging
Oncology clearance and documentation of surveillance or recommended wait time

Note

Supporting References for Documentation

Include references cited in the policy and Appendix to support clinical decisions and documentation during prior authorization. Key references include OPTN/Policy 9.5 and NLRB updates, the policy Appendix guidance on malignancy clearance, and relevant transplant oncology and allocation resources.

Cite OPTN Policy 9.5 and NLRB 'Updates Related to Transplant Oncology' (2/27/25) as applicable
Include literature and practice‑guideline references supporting malignancy‑specific wait times and management (see References section)

Documentation Required

Required Pretransplant Local Therapy

Ensure completion of recommended pretransplant local‑regional therapy where required by the policy (for example, neoadjuvant therapy for perihilar cholangiocarcinoma, locoregional therapy or resection and documented stability for certain iCCA/HCC indications). Prior authorization must include evidence of appropriate therapy and the required period of tumor stability when specified.

Document completion and dates of neoadjuvant or locoregional therapies when required
Provide evidence of tumor stability for the duration specified in the policy (e.g., 6 months of stability for unresectable iCCA or mixed HCC‑iCCA)

Downstaging eligibility: Candidate meets OPTN downstaging inclusion lesion criteria prior to local-regional therapy and after therapy viable lesions meet T2 criteria on dynamic CT/MRI.Lesion criteria in Policy 9.5.I.iii and post-treatment imaging confirmation

Candidates not initially meeting inclusion criteria who are later downstaged must be referred to the NLRB.

AFP >1000 prior history: Candidate with prior AFP >1000 must meet Policy 9.5.I.iv: if AFP falls to <500 ng/mL after treatment, eligible for standardized exception; if AFP ≥500 ng/mL after therapy, refer to NLRB.Post-treatment AFP <500 ng/mL

Cancer-specific candidate criteria

Cancer-specific candidate inclusion logic

General: Candidate must meet cancer-specific disease control thresholds and wait times as specified (eg, disease-free interval, EFS24/PFS24 where applicable), with oncology documentation of remission or stability.Disease-specific intervals as listed

Updated candidate disease-specific criteria

Revision notes added or revised candidate-related policy statements for specific diseases and malignancy history.

New/updated disease-specific statements: Added or updated policy statements for intrahepatic cholangiocarcinoma, colorectal liver metastases (CRLM), hepatic epithelioid hemangioendothelioma (HEHE), hepatic adenomas, cystic fibrosis, familial amyloid polyneuropathy (FAP), and malignancy history as noted in the revision details.

See full policy sections for exact eligibility criteria.

For liver‑kidney allocation, document confirmatory renal testing and dialysis history per OPTN criteria: measured/calculated GFR/CrCl values at required intervals and dialysis frequency where applicable.

Document GFR ≤60 mL/min for >90 days, CrCl/GFR ≤30 mL/min at registration or thereafter, or dialysis ≥ once every 7 days for the previous 6 weeks as applicable.

Documentation Required

Include cancer staging, treatment history, and risk markers in evaluation

Pretransplant evaluation should include cancer‑specific staging, treatment history, and risk stratification markers (e.g., PSA/Gleason for prostate, NMIBC/MIBC risk for bladder, EFS/PFS milestones for lymphomas) to support timing and eligibility.

Documentation Required

Use cited guidelines and literature to support evaluations

When preparing documentation for exceptions and evaluations, reference and apply the guideline and literature sources cited in the policy (AASLD, OPTN/NLRB policies, SRTR, transplant oncology literature) to support clinical reasoning.

Note

Maintain OPTN/NLRB‑compliant documentation for exceptions

Transplant programs and review boards must follow OPTN/NLRB reporting and documentation protocols for exception requests and allocation, consistent with policy references.

Note

Ensure documentation meets OPTN/NLRB and policy 9.5 requirements

Transplant programs and review boards must follow OPTN/NLRB reporting and documentation protocols for exception and allocation processes as cited in Policy 9.5 and related NLRB updates.

Liver transplantation for intrahepatic or extrahepatic cholangiocarcinoma is limited to very highly selected candidates or those enrolled in approved clinical trial protocols at select centers

iCCA trial availabilityClinical trials (e.g., NCT02878473, NCT04195503) investigate transplantation for intrahepatic CCA; referral to centers with approved protocols is recommended

Extrahepatic/hilar CCA criteriaConsider transplantation only for lymph node–negative, non-disseminated, locally advanced hilar CCA meeting strict size and no-metastasis criteria per NCCN guidance

Post-transplant dermatologic surveillance and follow-up cadence

Melanoma in situ — post-transplant follow-upWide local excision pretransplant; post-transplant dermatologic follow-up recommended every 3 months

Low-risk SCC surveillanceLow-risk cutaneous SCC: appropriate excision/Mohs pretransplant; no delay required before listing

High-risk SCC surveillance cadenceHigh-risk SCC (without perineural invasion): recommend treatment (excision/Mohs) and a 2-year wait; for certain high-risk features consider adjuvant radiation and 2–3 year surveillance

Transplant wait‑listing and listing decisions (disclaimer and scope)

Wait-listing disclaimerA disclaimer statement for transplant wait listing was added; specific post-transplant coverage details are not provided in this document segment

Post-transplant coverage not detailedThis excerpt does not specify post-transplant coverage duration or services beyond general procedure/global codes; refer to full policy for specifics

Prior authorization implicationWait-listing and listing decisions require documentation aligned with updated disease-specific criteria and NLRB/OPTN guidance

Benefits include shorter wait time and potentially lower primary non-function and reduced mortality related to waiting for a deceased donor organ

LDLT — donor risksLiving donor surgery carries donor surgical risks (complication rates and small mortality risk) and ethical considerations

T2 HCC — lesion definitions and AFP requirement

T2 lesion numeric definitionT2 HCC = one class 5 lesion ≥2 cm and ≤5 cm OR two to three class 5 lesions each ≥1 cm and ≤3 cm

AFP requirement for T2 standardized exceptionAFP ≤ 1000 ng/mL required for eligibility for a standardized MELD/PELD exception for T2 HCC

Handling prior AFP >1000Candidates with prior AFP >1000 must follow Policy 9.5.I.iv; if AFP falls <500 ng/mL after treatment they may qualify for standardized exception; if AFP ≥500 ng/mL refer to NLRB

Downstaging lesions — inclusion criteria and post-treatment requirements

Downstaging inclusion lesion sizesEligible downstaging pre-treatment lesions include: one class 5 lesion >5 cm and ≤8 cm; two–three class 5 lesions with at least one >3 cm, each ≤5 cm, total diameter ≤8 cm; or four–five class 5 lesions each <3 cm with total diameter ≤8 cm

Post-treatment requirementAfter local‑regional therapy, viable lesions must meet T2 criteria on dynamic-contrast CT or MRI to qualify for standardized exception

NLRB referral for atypical downstagingCandidates not initially meeting downstaging inclusion criteria who are later downstaged must be referred to the NLRB for exception consideration

NMIBC / MIBC — staging definitions and wait-time guidance

NMIBC definition elements (low risk)Low-risk NMIBC: solitary, <3 cm, low-grade, Ta tumor, absence of carcinoma in situ (CIS)

NMIBC/MIBC wait-time examplesNMIBC low/intermediate risk: 6 months before transplant; High-risk NMIBC and MIBC post‑radical cystectomy: 2 years; MIBC post‑chemoradiation: not an SOT candidate

Risk stratification purposeNMIBC and MIBC staging definitions are used to stratify recurrence risk and guide transplant timing

PSA — role in prostate cancer risk stratification

PSA usageProstate specific antigen (PSA) is used in prostate cancer risk stratification and to inform wait-time decisions

Low-volume intermediate-risk criteriaLow-volume intermediate risk may include PSA >10 ng/mL or Gleason 7 (grade group 2 or 3)

Transplant timing based on nomogramIf under surveillance or if treatment-initiated nomogram predicts <10% cancer-specific death over 15 years, no wait time is required

EFS24 / PFS24 — milestone definitions and use

EFS24 / PFS24 definitionEvent-free survival (EFS) and progression-free survival (PFS) at 24 months used as disease‑control milestones

Use in hematologic malignanciesAchievement of EFS24/PFS24 is used to justify a typical 2-year interval before SOT in many aggressive lymphoma subtypes

Implication for listingEFS24/PFS24 milestones inform timing decisions and support documentation of durable remission prior to listing

MELD/PELD — OPTN allocation resources and references

OPTN allocation referencesOPTN/UNOS Policy 9 and NLRB updates are referenced for allocation and exception handling; OPTN allocation calculators (MELD/PELD) are used to prioritize candidates

NLRB updates citedNLRB 'Updates Related to Transplant Oncology' (2/27/25) referenced for exception eligibility nuances (e.g., treated T2 recurrence eligibility window)

Allocation calculators resourceOPTN allocation calculators are listed among the references for scoring and allocation determinations

SECA and transplant oncology studies cited for CRLM evidence

SECA and CRLM studies citedSECA transplant oncology studies and multiple recent transplant/CRLM publications cited as evidence evaluating transplantation for unresectable colorectal liver metastases

Contemporary literature supportRecent reviews and surgical literature (2023–2024) are listed to support CRLM policy statements and the need for standardized reporting

Clinical trial and registry referencesReferences include SECA trial arms and SRTR/OPTN resources informing transplant oncology decisions

2024-05-15annual review - revisions

Revised policy statement for liver transplantation and revised policy statement for mechanical preservation machines (operational/technical update).

This policy has a material change flag and the revision summary notes that policy statements regarding history of malignancy were added, a disclaimer for transplant wait listing was included, and multiple disease‑specific policy statements were added or revised (including iCCA, CRLM, HEHE, hepatic adenomas, cystic fibrosis, and FAP). Program prior authorization and documentation processes should reflect these updated or new disease‑specific criteria.