CurrentDHAPolicy 6010.63-M

Combined Liver-Kidney Transplantation (CLKT) Coverage Criteria

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Coverage criteria and authorization requirements for combined liver-kidney transplantation under the DHA transplant surgery policy manual.

Policy Summary

PayerDHA

PolicyCombined Liver-Kidney Transplantation (CLKT) Coverage Criteria

Policy CodePolicy 6010.63-M

Change TypeNo material change

Effective DateDec 1, 1996

Next Review DateN/A

Key ActionTRICARE Prime enrollees must obtain a Primary Care Manager referral and contractor authorization before receiving transplant-related services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Organs included

3Core coverage criteria

3Contraindication categories

2Certified facility pathways

24 hoursEarly-discharge threshold

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CurrentDHAPolicy 6010.63-M

Combined Liver-Kidney Transplantation (CLKT) Coverage Criteria

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Sign up for DHA Policy 6010.63-M alerts

Get alerted when Policy 6010.63-M changes without checking for updates manually.

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Coverage criteria and authorization requirements for combined liver-kidney transplantation under the DHA transplant surgery policy manual.

Policy Summary

PayerDHA

PolicyCombined Liver-Kidney Transplantation (CLKT) Coverage Criteria

Policy CodePolicy 6010.63-M

Change TypeNo material change

Effective DateDec 1, 1996

Next Review DateN/A

Key ActionTRICARE Prime enrollees must obtain a Primary Care Manager referral and contractor authorization before receiving transplant-related services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Organs included

3Core coverage criteria

3Contraindication categories

2Certified facility pathways

24 hoursEarly-discharge threshold

Combined Liver-Kidney Transplant Coverage

Initial CLKT coverage criteria

CLKT is covered when all of the following are met.

CLKT medical necessity and facility criteria

Clinical criteria
- The beneficiary has concomitant, irreversible hepatic and renal failure.
- The beneficiary has exhausted more conservative medical and surgical treatments for hepatic and renal failure.
- The beneficiary has a feasible and realistic plan for long-term adherence to a disciplined medical regimen.
Eligible transplant facility
- The transplant is performed at a TRICARE-certified liver transplant center.
- The transplant is performed at a Medicare-certified liver transplant center.
- The transplant is performed at a TRICARE-certified pediatric consortium liver transplantation center.

Covered CLKT-related services

Covered services and supplies include the following when related to an otherwise eligible CLKT.

Related covered services

Evaluation of a potential candidate's suitability for CLKT, whether or not the patient is ultimately accepted as a candidate for transplantation.
Pre- and post-transplant inpatient hospital and outpatient services.
Pre- and post-operative services of the transplant team.
Donor acquisition team services, including transportation to the location of the donor organ and transportation of the team and donated organ to the transplantation center.
Maintenance of the viability of the donor organ after all existing legal requirements for excision of the donor organ have been met.

Exclusions and contraindications

CLKT is excluded when any of the following applies.

Transplant contraindications and exclusions

Significant systemic or multisystemic disease, other than hepatorenal failure, limits the possibility of full recovery and may compromise the function of the newly transplanted organs.
Active alcohol or other substance abuse interferes with compliance with the strict treatment regimen.
Malignancy has metastasized to or extends beyond the margins of the liver and/or kidney.
Expenses were waived by the transplant center, meaning the beneficiary or sponsor is not financially liable.
Services or supplies are not provided in accordance with applicable program criteria, including services or supplies provided as part of a grant or research program or involving an unproven procedure.

Excluded expenses and services: Expenses waived by the transplant center are not covered when the beneficiary or sponsor is not financially liable. Services and supplies furnished outside applicable program criteria are also excluded, including those provided as part of a grant or research program or involving an unproven procedure. Administration of an immunosuppressant that is not FDA-approved and lacks support as an appropriate off-label indication is excluded.

Acquisition and donor costs are not components of the CLKT DRG and must be billed separately on a standard CMS 1450 UB-04 claim in the name of the TRICARE patient. Transportation of the donor organ and transplant team may be covered when billed charges do not exceed the transport service's published schedule of charges; these services are cost-shared on an inpatient basis, and scheduled or chartered transportation may be cost-shared. Transportation of the organ donor is excluded.

Covered Procedure Codes

Covered CPT CodesCPTCovered

47133	CPT code listed for CLKT
47134	CPT code listed for CLKT
47135	CPT code listed for CLKT
50300	CPT code listed for CLKT
50340	CPT code listed for CLKT
50360	CPT code listed for CLKT
50365	CPT code listed for CLKT

Authorization, Billing, and Denial Risks

Prior Authorization

PCM Referral and Contractor Authorization

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 are subject to penalties under their TRICARE network provider agreements.

Applies to transplant-related services for TRICARE Prime enrollees.
Obtain the PCM referral and contractor authorization before services are provided.

Prior Authorization

Contractor Preauthorization Authority

The contractor is the preauthorization authority for beneficiaries residing in its geographic area of responsibility. This applies to TRICARE Standard and TRICARE Extra patients through December 31, 2017, and to TRICARE Select enrollees beginning January 1, 2018.

TRICARE Standard and TRICARE Extra: through December 31, 2017.
TRICARE Select: beginning January 1, 2018.

Clinical Context

Combined liver-kidney transplantation (CLKT) treats patients with simultaneous irreversible hepatic and renal failure when more conservative medical and surgical treatments have been exhausted. The policy covers the transplant episode and related care, including candidate evaluation, transplant hospitalization, outpatient and transplant-team services, donor-related services, immunosuppression, management of complications such as infection and rejection, and periodic post-transplant assessment.

Key Term

Combined liver-kidney transplantation (CLKT)

ProcedureCombined liver-kidney transplantation (CLKT) is a transplant procedure in which a liver and a kidney are transplanted for a beneficiary with concomitant hepatic and renal failure.

Hepatic and renal conditionCoverage requires concomitant, irreversible hepatic and renal failure.

Prior treatmentThe beneficiary must have exhausted more conservative medical and surgical treatments for hepatic and renal failure.

Long-term adherenceThe beneficiary must have a feasible and realistic plan for long-term adherence to a disciplined medical regimen.

Beneficiary Eligibility

Candidate eligibility

A beneficiary is eligible for CLKT coverage when all clinical and facility criteria are met.

CLKT candidate eligibility

Clinical criteria
- The candidate has concomitant, irreversible hepatic and renal failure.
- The candidate has exhausted more conservative medical and surgical treatments for hepatic and renal failure.
- The candidate has a feasible and realistic plan for long-term adherence to a disciplined medical regimen.
  Hepatic failure resulting from hepatitis B or C is covered when the other CLKT criteria are met.
Eligible transplant facility

Conditions Excluding Coverage

CLKT is contraindicated when a condition other than hepatorenal failure limits the possibility of full recovery or may compromise the function of the transplanted organs. This includes significant systemic or multisystemic disease, active alcohol or other substance abuse that interferes with compliance with the strict treatment regimen, and malignancy that has metastasized to or extends beyond the margins of the liver and/or kidney.

Candidate Evaluation

Note

Evaluate potential candidates

Evaluation of a potential candidate’s suitability for CLKT is covered whether or not the patient is ultimately accepted as a candidate for transplantation.

DNA-HLA tissue typing may be covered to determine histocompatibility.
For emergency transplantation at an unauthorized facility, consultation with the nearest certified liver transplant center and documented determination that transfer is not medically reasonable are required.

Transplant Facility Standards

Documentation Required

Verify transplant-center certification

Perform the transplant at a TRICARE- or Medicare-certified liver transplant center. A pediatric facility may qualify when it is TRICARE-certified as a liver transplantation center through a pediatric consortium whose combined experience and survival data meet TRICARE certification criteria.

The contractor in whose jurisdiction the center is located is the certifying authority for TRICARE approval as a liver transplantation center.
Refer to Chapter 11, Section 7.1 for organ transplant center certification requirements.

Ongoing Care and Monitoring

Post-transplant care and monitoring

Care settingCovered services include pre- and post-transplant inpatient hospital and outpatient services.

Transplant-team servicesPre- and post-operative services of the transplant team are covered.

Complication managementCoverage includes complications of the transplant procedure, including inpatient care and management of infection and rejection episodes.

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

VaccinationHepatitis B and pneumococcal vaccines are covered for patients undergoing transplantation.

Policy Summary

PayerDHA

PolicyCombined Liver-Kidney Transplantation (CLKT) Coverage Criteria

Policy CodePolicy 6010.63-M

Change TypeNo material change

Effective DateDec 1, 1996

Next Review DateN/A

Key ActionTRICARE Prime enrollees must obtain a Primary Care Manager referral and contractor authorization before receiving transplant-related services.

SourceLink

On This Page

Blood and blood products.

U.S. Food and Drug Administration-approved immunosuppression drugs, including off-label uses when reliable evidence documents that the use is safe, effective, and in accordance with national standards of practice in the medical community.

Off-label use must be proven by reliable evidence.

Complications of the transplant procedure, including inpatient care and management of infection and rejection episodes.

Periodic evaluation and assessment of the successfully transplanted patient.

Hepatitis B and pneumococcal vaccines for patients undergoing transplantation.

Deoxyribonucleic Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility.

Transportation of the patient by air ambulance and the services of a certified life support attendant.

An unproven immunosuppressant drug that is not FDA approved or has not received approval as an appropriate off-label drug indication is administered.

Pre- or post-transplant nonmedical expenses, such as lodging and meals, are claimed.

Transportation of an organ donor is claimed.

Documentation Required

Emergency Unauthorized-Facility Documentation

An emergency CLKT performed at an unauthorized liver transplant facility may be cost-shared only when the required consultation and medical-necessity documentation are completed.

The unauthorized facility must consult with the nearest TRICARE- or Medicare-certified liver transplantation center.
Transplant team physician(s) at the certified center must determine and document that transfer to the certified center is not medically reasonable, even though transplantation is feasible and appropriate.

Billing Rule

Separate Acquisition and Donor-Cost Billing

Acquisition and donor costs are not components of the CLKT DRG and must be billed separately in the name of the TRICARE patient.

Submit a standard CMS 1450 UB-04 claim form.
Bill acquisition and donor costs separately from the DRG-paid transplant services.

Billing Rule

Organ and Transplant-Team Transportation Billing

Transportation claims for the donor organ and transplant team are adjudicated on billed charges, subject to the transport service’s published schedule of charges, and are cost-shared on an inpatient basis.

Scheduled or chartered transportation may be cost-shared.
Charges may not exceed the transport service’s published schedule of charges.

Denial Risk

Clinical or Facility Requirements Must Be Met

Benefits depend on the transplant being performed at an eligible certified facility and on the beneficiary meeting the applicable clinical requirements. Claims may be denied when certification, clinical eligibility, or other program requirements are not met.

Facility must be a TRICARE- or Medicare-certified liver transplantation center, or a TRICARE-certified pediatric consortium liver transplantation center.
Beneficiary must have concomitant, irreversible hepatic and renal failure.
More conservative medical and surgical treatments must have been exhausted.
A feasible and realistic plan for long-term adherence to a disciplined medical regimen is required.
The contractor in whose jurisdiction the center is located is the certifying authority for TRICARE approval.

Denial Risk

Contraindications or Unproven Treatment

CLKT is excluded when specified contraindications or unproven treatment conditions are present.

Significant systemic or multisystemic disease, other than hepatorenal failure, limits the possibility of full recovery or may compromise the newly transplanted organs.
Active alcohol or other substance abuse interferes with compliance with the strict treatment regimen.
Malignancy has metastasized to or extends beyond the margins of the liver and/or kidney.
Services or supplies are provided as part of a grant or research program or otherwise involve an unproven procedure.
An immunosuppressant is not FDA-approved and lacks approval as an appropriate off-label indication.

Denial Risk

Missing Referral or Authorization

Failure to obtain required referral or authorization does not automatically establish full coverage and can materially change reimbursement. The appropriate preauthorizing authority must review whether the condition meets CLKT clinical criteria when preauthorization was not obtained.

For TRICARE Prime, transplant and transplant-related services without the required PCM referral and contractor authorization are reimbursed only under Point of Service (POS) rules.
Non-network civilian provider services furnished to a Prime enrollee without the required referral and authorization are subject to POS cost-sharing.
If services otherwise qualify for benefits, benefits may be extended despite missing preauthorization, subject to the applicable review.

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The transplant is performed at a TRICARE-certified liver transplant center.

The transplant is performed at a Medicare-certified liver transplant center.

The transplant is performed at a TRICARE-certified pediatric consortium liver transplantation center.