ModifiedDHAPolicy 6010.60-M

Liver Transplantation

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Coverage criteria for liver and living donor liver transplantation, including candidate eligibility, rare-disease indications, colorectal cancer with liver metastases, authorization, and transplant-related services.

Policy Summary

PayerDHA

PolicyLiver Transplantation

Policy CodePolicy 6010.60-M

Change TypeModified

Effective DateSep 21, 2024

Next Review DateN/A

Key ActionObtain prior authorization and tumor board approval for colorectal cancer with liver metastases before transplantation.

SourceLink

POLICY UPDATE CHANGES

The general liver-transplantation criteria were revised to require feasible and realistic plans for long-term adherence to a disciplined medical regimen.

Coverage was added for orthotopic liver transplantation for Acute Intermittent Porphyria under TRICARE rare-disease provisions.

Coverage was added for liver transplantation for unresectable or nonresectable colorectal cancer with liver metastases when prior authorization, tumor board approval, and all inclusion criteria are satisfied.

The policy expanded and clarified covered transplant-related services, including candidate evaluation, donor acquisition, immunosuppression, complications, follow-up, tissue typing, and air ambulance transportation.

The exclusions were revised to provide an exception for unresectable colorectal cancer with liver metastases meeting the dedicated transplant criteria.

24.5Manual section

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ModifiedDHAPolicy 6010.60-M

Liver Transplantation

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Policy Summary

PayerDHA

PolicyLiver Transplantation

Policy CodePolicy 6010.60-M

Change TypeModified

Effective DateSep 21, 2024

Next Review DateN/A

Key ActionObtain prior authorization and tumor board approval for colorectal cancer with liver metastases before transplantation.

SourceLink

POLICY UPDATE CHANGES

The general liver-transplantation criteria were revised to require feasible and realistic plans for long-term adherence to a disciplined medical regimen.

Coverage was added for orthotopic liver transplantation for Acute Intermittent Porphyria under TRICARE rare-disease provisions.

The exclusions were revised to provide an exception for unresectable colorectal cancer with liver metastases meeting the dedicated transplant criteria.

24.5Manual section

Covered procedure codes

4General candidate conditions

>50%CRC survival threshold

70 cm³ / 260 gTumor burden exclusions

12Covered service categories

Liver Transplantation Coverage Criteria

Initial liver or LDLT coverage criteria

Covered when all of the following are met:

General liver or LDLT coverage criteria

Clinical and treatment requirements
- Irreversible hepatic disease: The beneficiary is suffering from irreversible hepatic disease.
- Alternative treatments exhausted: Alternative medical and surgical treatments have been exhausted.
- Long-term adherence feasibility: Plans for long-term adherence to a disciplined medical regimen are feasible and realistic.

CRC with liver metastases inclusion criteria

Covered when all inclusion criteria are met, all exclusion criteria are absent, prior authorization is obtained, and tumor board approval is documented:

CRC with liver metastases coverage requirements

Authorization and approval
- Prior authorization is obtained.
- Tumor board approval is obtained.
Inclusion criteria
- Liver-only unresectable disease: Unresectable colorectal cancer with liver metastases is contained solely within the liver.
- Primary tumor resection:

CRC with liver metastases exclusion criteria

Not covered when any exclusion criterion is present:

Disqualifying histology: Primary tumor histology is undifferentiated adenocarcinoma or signet ring cell carcinoma.
Excessive tumor burden
- Metabolic tumor volume exceeds 70 cubic centimeters.>70 cm³
- Total lesion glycolysis exceeds 260 grams.>260 g
Nodal disease

Rare-disease transplant indications

May be covered under applicable TRICARE rare-disease provisions:

Rare-disease indications

Severe classical MSUD: Severe classical Maple Syrup Urine Disease not controlled by dietary restriction may be considered on a case-by-case basis.
Pediatric OTCD: Liver transplantation for pediatric Ornithine Transcarbamylase Deficiency may be covered for the specified class of beneficiaries.
CTLN1: Liver transplantation may be covered for Citrullinemia Type 1.
Acute Intermittent Porphyria: Orthotopic liver transplantation may be covered for Acute Intermittent Porphyria.CPT 47135

Liver transplantation and living donor liver transplantation (LDLT) are excluded when significant systemic or multisystemic disease, other than hepatorenal failure, limits the possibility of full recovery or may compromise the function of the transplanted organ. Coverage is also excluded for active alcohol or other substance abuse that interferes with compliance with the strict treatment regimen. Malignancies that have metastasized to or extended beyond the margins of the liver are excluded, except for qualifying unresectable colorectal cancer with liver metastases under the policy's dedicated criteria.

The policy excludes expenses waived by the transplantation center, including expenses for which the beneficiary or sponsor is not financially liable. It also excludes services and supplies provided as part of a grant or research program, unproven procedures, administration of unproven or inadequately approved immunosuppressant drugs, nonmedical pre- or post-transplant living expenses, transportation of an organ donor, and artificial assist devices that are not FDA approved or are used outside FDA-approved indications.

Services and supplies must be provided in accordance with the applicable transplant program criteria. Items that do not meet those criteria—including services supplied through a grant or research program or involving an unproven procedure—are excluded. Coverage is also unavailable for services that fail the applicable clinical or program requirements for the transplant pathway.

Procedure Codes and Clinical Thresholds

Covered CPT CodesCPTCovered

47133	Liver transplantation procedure code
47134	Liver transplantation procedure code
47135	Orthotopic liver transplantation (OLT)
47136	Liver transplantation procedure code
47140	Living donor liver transplantation procedure code
47141	Living donor liver transplantation procedure code
47142	Living donor liver transplantation procedure code

Patient-Specific Expected Five-Year Survival

Required survivalPatient-specific expected five-year survival must be greater than 50%.

Applies toLiver transplantation for unresectable or nonresectable colorectal cancer with liver metastases.

Coverage statusA survival estimate of 50% or less does not meet the stated inclusion criterion.

Metabolic Tumor Volume

Exclusion thresholdMetabolic tumor volume greater than 70 cubic centimeters is exclusionary.

Clinical pathwayThis threshold applies to liver transplantation for colorectal cancer with liver metastases.

Authorization, Documentation, and Denial Risks

Prior Authorization

Referral and Preauthorization Required

TRICARE Prime enrollees must obtain both a Primary Care Manager (PCM) referral and contractor authorization before receiving transplant-related services. Network providers that furnish services without both requirements may incur penalties under TRICARE network agreements; non-network civilian services are reimbursed only on a Point of Service (POS) basis, with applicable POS cost sharing. For Standard and Extra beneficiaries through December 31, 2017, and TRICARE Select enrollees beginning January 1, 2018, in an MCS region, preauthorization is handled by the MCS Medical Director or designated utilization staff.

Prior Authorization

CRC Transplant Authorization

Liver transplantation for unresectable or nonresectable colorectal cancer (CRC) with liver metastases (LM) requires prior authorization and tumor board approval before coverage can be considered. All inclusion criteria must be met and all CRC exclusion criteria must be absent.

The LM must be contained solely within the liver.
The primary tumor must be resected with clear margins.
The patient must have a favorable biological response to chemotherapy and bridging therapy to transplantation for at least six months, with imaging stability or response for at least three months during the last systemic line.

Policy Scope and Clinical Context

This policy establishes coverage requirements for liver transplantation and living donor liver transplantation (LDLT) in beneficiaries with irreversible hepatic disease after alternative medical and surgical treatments have been exhausted. It also addresses selected rare or metabolic diseases and provides a narrowly defined pathway for unresectable or nonresectable colorectal cancer with liver-only metastases. Covered transplant-related services may include candidate evaluation, transplant admission and follow-up, donor acquisition, immunosuppression, management of complications and rejection or infection, and periodic post-transplant assessment, subject to the applicable criteria and authorization requirements.

Transplantation Terms

Living Donor Liver Transplantation (LDLT)

AbbreviationLDLT.

DefinitionLiving donor liver transplantation.

Policy scopeBenefits are allowed for liver and living donor liver transplantations.

Orthotopic Liver Transplantation (OLT)

AbbreviationOLT.

DefinitionOrthotopic liver transplantation.

Acute Intermittent Porphyria referenceCPT code 47135 is specified for orthotopic liver transplantation for Acute Intermittent Porphyria under TRICARE rare-disease provisions.

Candidate Eligibility

Liver and LDLT candidate criteria

Covered when performed at an authorized transplant center and all of the following clinical criteria are met:

Authorized transplant center: The transplantation is performed at a TRICARE- or Medicare-certified liver transplantation center, or at a TRICARE-certified pediatric consortium liver transplantation center.
Irreversible hepatic disease: The beneficiary has irreversible hepatic disease.
Failed alternative treatments: Alternative medical and surgical treatments have been exhausted.
Adherence plan: Plans for long-term adherence to a disciplined medical regimen are feasible and realistic.

Contraindications to Transplantation

Contraindications include significant systemic or multisystemic disease, other than hepatorenal failure, that limits the possibility of full recovery or may compromise the transplanted organ; active alcohol or other substance abuse that interferes with compliance with the strict treatment regimen; and malignancy metastasized to or extending beyond the margins of the liver, except for qualifying unresectable colorectal cancer with liver metastases. Unresectable colorectal cancer with liver metastases is also contraindicated when any required inclusion criterion is not met or any exclusion criterion is present, including disqualifying tumor biology or burden, extrahepatic disease, unfavorable nodal or molecular findings, an exclusionary carcinoembryonic antigen profile, or disease progression. Unproven procedures, unsupported immunosuppressants, and artificial assist devices lacking FDA approval or used outside FDA-approved indications are likewise contraindicated or excluded.

Candidate Evaluation

Note

Candidate evaluation may be covered

Evaluation of a potential candidate’s suitability for liver transplantation is covered even if the patient is ultimately not accepted as a transplant candidate.

Candidate evaluation remains covered when transplantation is not ultimately performed

Authorized Transplant Centers

Documentation Required

Verify transplant-center certification

Transplantation must be performed at a TRICARE- or Medicare-certified liver transplantation center. A pediatric transplant may be performed at a TRICARE-certified pediatric consortium liver transplantation center whose combined experience and survival data meet TRICARE certification criteria; the contractor in the center’s jurisdiction is the certifying authority for TRICARE authorization.

Verify TRICARE or Medicare certification before transplantation
For pediatric cases, verify TRICARE-certified consortium status
Confirm the responsible contractor’s authorization

Post-Transplant Services and Logistics

Post-Transplant Medical and Surgical Care

Hospital carePre- and post-transplantation inpatient hospital and outpatient services are covered.

Transplant teamPreoperative and postoperative services of the transplantation team are covered.

ComplicationsComplications of the transplantation procedure are covered, including inpatient care and management of infection and rejection episodes.

Follow-upPeriodic evaluation and assessment of the successfully transplanted patient are covered.

ImmunosuppressionFDA-approved immunosuppression drugs are covered, including proven off-label uses supported by reliable evidence and nationally accepted standards of practice.

Additional servicesDNA-HLA tissue typing for histocompatibility and qualifying patient air ambulance transportation with a certified life support attendant are covered.

Policy Summary

PayerDHA

PolicyLiver Transplantation

Policy CodePolicy 6010.60-M

Change TypeModified

Effective DateSep 21, 2024

Next Review DateN/A

Key ActionObtain prior authorization and tumor board approval for colorectal cancer with liver metastases before transplantation.

SourceLink

On This Page

The primary tumor was resected with clear resection margins.

Favorable treatment response: There is a favorable biological response to chemotherapy and bridging therapy to transplantation for at least six months, with imaging stability or response for at least three months during the last systemic line.Chemotherapy and bridging therapy ≥6 months; imaging stability or response ≥3 months

Expected survival: Patient-specific expected five-year survival is greater than 50%.>50%

Exclusion criteria absent: All exclusion criteria for colorectal cancer with liver metastases are absent.

The primary tumor has N2 nodal disease, except in late metachronous non-resectable colorectal liver metastases without nodal recurrence.N2

Extrahepatic disease: Extrahepatic or extracolonic metastases or other extrahepatic metastatic disease is present.

CRC-associated syndrome: A known syndrome associated with colorectal cancer, such as Lynch syndrome or a BRAF V600E variant, is present.

Molecular exclusion: Metastatic colorectal cancer is microsatellite instability-high or mismatch repair deficient.

Unfavorable CEA or progression

Carcinoembryonic antigen is greater than 80 micrograms per liter with an increasing trend.>80 micrograms/L with increasing trend
Carcinoembryonic antigen is greater than 80 micrograms per liter without other favorable biologic factors.>80 micrograms/L without other favorable biologic factors
There is radiological or biochemical evidence of cancer progression.

Coverage effectExceeding the threshold is an exclusion criterion for transplantation.

Total Lesion Glycolysis

Exclusion thresholdTotal lesion glycolysis greater than 260 grams is exclusionary.

Clinical pathwayThis threshold applies to liver transplantation for colorectal cancer with liver metastases.

Coverage effectExceeding the threshold is an exclusion criterion for transplantation.

Carcinoembryonic Antigen

CEA thresholdCarcinoembryonic antigen greater than 80 micrograms per liter is the specified threshold.

Increasing trendCEA greater than 80 micrograms per liter with an increasing trend is exclusionary.

Other biologic factorsCEA greater than 80 micrograms per liter without other favorable biologic factors is exclusionary.

Additional exclusionRadiological or biochemical evidence of cancer progression is also exclusionary.

Early Discharge After Transplant Admission

Discharge timingDischarge less than 24 hours after admission may still be cost-shared on an inpatient basis.

Authorization requirementThe transplantation candidate must have been properly preauthorized.

Required circumstanceExtenuating circumstances must have prevented timely transplantation, such as an available organ being found unsuitable.

Cost-sharing conditionAll otherwise authorized services associated with the admission remain eligible for inpatient cost-sharing because the expectation at admission was that the patient would remain more than 24 hours.

Patient-specific expected five-year survival must be greater than 50%.

Denial Risk

Failure to Obtain Authorization

If preauthorization was not obtained, the appropriate preauthorizing authority must review the claim to determine whether the beneficiary meets the clinical transplantation criteria. Benefits may be extended when the services or supplies otherwise qualify, but TRICARE Prime enrollees are reimbursed only under POS rules.

Failure to obtain preauthorization can affect coverage and reimbursement even when the transplant might otherwise qualify.
The review applies to liver and living donor liver transplantation for beneficiaries residing in TRICARE regions.

Documentation Required

Clinical Eligibility Documentation

Document that the candidate has irreversible hepatic disease, has exhausted alternative medical and surgical treatments, and can realistically adhere to a disciplined long-term medical regimen. For CRC with LM, the record must also establish the applicable inclusion criteria, including liver-confined unresectable disease, clear-margin primary-tumor resection, treatment response and stability, and expected five-year survival greater than 50%.

The former terminal-phase requirement was deleted in Revision C-152.
Irreversible hepatic disease resulting from hepatitis B or C is covered when other applicable requirements are met.
Document the clinical basis for determining that alternatives have been exhausted and that long-term adherence is feasible and realistic.

Documentation Required

CRC Transplant Workup

For CRC with LM, the transplant workup must document completion of primary-tumor resection with clear margins, a favorable biological response to chemotherapy and bridging therapy for at least six months, and imaging stability or response for at least three months during the last systemic treatment line.

Document that the metastatic disease is unresectable or nonresectable and contained solely within the liver.
Include treatment history, response assessment, serial imaging, and the patient-specific expected five-year survival estimate (>50%).

Documentation Required

Multidisciplinary Unresectability Determination

Before referral to a transplant center for CRC with LM, arrange for the unresectable or nonresectable determination to be made, when possible, by a military or private-sector multidisciplinary cancer conference, such as the Murtha Cancer Center at Walter Reed National Military Medical Center. Retain the conference and multidisciplinary clinical documentation in the referral record.

The determination should be made before referral to the transplant center.
Document the participating cancer-conference or multidisciplinary team and its conclusion regarding resectability.

Documentation Required

Emergency Unauthorized-Facility Documentation

An emergency liver or living donor liver transplant performed at an unauthorized facility may be cost-shared only when the required emergency documentation is complete and all other TRICARE contractual requirements are satisfied.

The unauthorized center must consult with the nearest TRICARE- or Medicare-certified liver transplantation center.
Transplantation-center physician(s) must determine and document that transfer to the certified center is not medically reasonable, even though transplantation is feasible and appropriate.
Retain the consultation, physician certification, and emergency clinical rationale.

Billing Rule

Donor and Acquisition Billing Documentation

Donor hospital charges must be fully itemized and billed by the transplantation center in the name of the TRICARE patient. Acquisition and donor costs are not included in the DRG and must be billed separately on a standard CMS-1450 UB-04 claim in the patient's name.

Transportation of the donor organ and transplantation team is adjudicated at billed charges, not exceeding the transport service's published schedule, and is cost-shared on an inpatient basis; scheduled or chartered transportation may be cost-shared.
Transportation of an organ donor is excluded.
Donor hospital charges are cost-shared on an inpatient basis.

Denial Risk

Authorized Transplant Center Required

Benefits are allowed only when the transplant is performed at a TRICARE- or Medicare-certified liver transplantation center, or at a TRICARE-certified pediatric consortium liver transplantation center whose combined experience and survival data meet TRICARE certification criteria. A transplant performed outside an authorized or certified center is at risk for denial unless the emergency unauthorized-facility requirements are satisfied.

The contractor with jurisdiction over the center is the certifying authority for TRICARE authorization as a liver transplantation center.
Verify center certification before transplantation and document the authorized facility.

Denial Risk

Candidate Criteria Not Met

Coverage is at risk when the candidate does not have irreversible hepatic disease, has not exhausted alternative medical or surgical treatments, or cannot demonstrate a feasible and realistic plan for long-term adherence to a disciplined medical regimen. For CRC with LM, failure to meet any inclusion criterion also places the transplant at risk for denial.

Document the irreversible nature of the disease and the failure of appropriate alternatives.
Document adherence capacity and the rationale supporting long-term compliance.
For CRC with LM, all inclusion criteria must be met and the disease must remain confined solely to the liver.

Denial Risk

CRC Exclusion Criteria

Liver transplantation for CRC with LM is excluded when any listed CRC exclusion criterion is present. Review and document tumor biology, burden, nodal status, metastatic distribution, syndromic features, biomarkers, and evidence of progression before authorization and referral.

Undifferentiated adenocarcinoma or signet ring cell carcinoma; metabolic tumor volume >70 cubic centimeters; or total lesion glycolysis >260 grams.
N2 nodal disease, except late metachronous non-resectable colorectal LM without nodal recurrence.
Extrahepatic or extracolonic metastases or other extrahepatic metastatic disease.
Known CRC-associated syndromes, including Lynch syndrome or a BRAF V600E variant.
Microsatellite instability-high or mismatch repair-deficient metastatic CRC.
CEA >80 micrograms per liter with an increasing trend, or CEA >80 micrograms per liter without other favorable biologic factors; radiological or biochemical evidence of cancer progression.

Denial Risk

Contraindications and Excluded Services

Liver transplantation and living donor liver transplantation are excluded when contraindications or excluded services apply, including significant systemic or multisystemic disease that limits recovery or may compromise the transplanted organs and active alcohol or other substance abuse that interferes with compliance.

Malignancy extending beyond the liver margins or metastasized beyond the liver is excluded, except for qualifying unresectable CRC with LM under the CRC criteria.
Expenses waived by the transplantation center, services or supplies provided as part of a grant or research program, and unproven procedures are excluded.
Unproven immunosuppressants that are not FDA approved or approved for an appropriate off-label indication are excluded.
Pre- or post-transplant nonmedical living expenses, including hotel, meals, and privately owned vehicle expenses, are excluded.
Artificial assist devices that are not FDA approved or are not used according to FDA-approved indications are excluded.

Unresectable/Nonresectable CRC With Liver Metastases

DiseaseColorectal cancer with liver metastases.

ResectabilityThe liver metastases cannot be removed by surgical resection and are described as unresectable or nonresectable.

Liver distributionFor the transplant pathway, the unresectable colorectal cancer with liver metastases must be contained solely within the liver.

Pathway requirementsPrior authorization and tumor board approval are required, and all inclusion criteria must be met with all exclusion criteria absent.

Donor Acquisition and Transplant Logistics

Donor acquisitionDonor acquisition team services are covered, including transportation to the donor-organ location and transportation of the team and donated organ to the transplantation center.

Donor costsDonor costs are covered and must be billed separately from services included under the DRG.

Blood productsBlood and blood products are covered.

Organ viabilityMaintenance of donor-organ viability after all legal requirements for excision have been met is covered.

Transportation billingTransportation of the donor organ and transplantation team is adjudicated on billed charges, not exceeding the transport service's published schedule of charges, and is cost-shared on an inpatient basis; scheduled or chartered transportation may be cost-shared.

Required claimsDonor hospital charges must be fully itemized and billed by the transplantation center in the TRICARE patient's name; acquisition and donor costs must be submitted separately on a CMS 1450 UB-04 claim.