Chapter 4 Section 24.5

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Surgery Chapter 4 Section 24.5 Issue Date: September 3, 1986 Authority: 32 CFR 199.4(e)(5) 1.0 CPT 1 PROCEDURE CODES 47133-47136, 47140-47142 2.0 POLICY 2.1 Benefits are allowed for liver and Living Donor s (LDLT). 2.1.1 A TRICARE Prime enrollee must have a referral from his/her Primary Care Manager (PCM) and an authorization from the contractor before obtaining transplant-related services. If network providers furnish transplant-related services without prior PCM referral and contractor authorization, penalties will be administered according to TRICARE network provider agreements. If Prime enrollees receive health care services from non-network civilian providers without the required PCM referral and contractor authorization, Managed Care Support Contractors (MCSCs) shall reimburse charges for the services on a Point of Service (POS) basis. Special cost-sharing requirements apply to POS claims. 2.1.2 For Standard and Extra patients residing in a Managed Care Support (MCS) region, preauthorization is the responsibility of the MCS Medical Director or other designated utilization staff. 2.2 Liver and LDLT is covered when the transplantation is performed at a TRICARE or Medicarecertified liver transplantation center or TRICARE-certified pediatric consortium liver transplantation center for beneficiaries who: 2.2.1 Are suffering from irreversible hepatic disease; and 2.2.2 Have exhausted alternative medical and surgical treatments; and 2.2.3 Are approaching the terminal phase of their illness. 2.2.4 Demonstrate plans for a long-term adherence to a disciplined medical regimen are feasible and realistic. 2.3 Liver and LDLT transplants performed for beneficiaries suffering from irreversible hepatic disease resulting from hepatitis B or C is covered. 1 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

2.4 Liver transplantation for severe classical Maple Syrup Urine Disease (MSUD) not controlled by dietary restriction may be considered on a case-by-case basis under the TRICARE provisions for the treatment of rare diseases. 2.5 Liver transplantation for the treatment of pediatric Ornithine Transcarbamylase Deficiency (OTCD) may be covered for this specific class of beneficiaries in accordance with the TRICARE provisions for the treatment of rare diseases. 2.6 Liver transplantation may be covered for the treatment of Citrullinemia Type 1 (CTLN1) in accordance with the TRICARE provisions for the treatment of rare diseases. 2.7 Services and supplies related to liver and LDLTs are covered for: 2.7.1 Evaluation of a potential candidate s suitability for liver transplantation whether or not the patient is ultimately accepted as a candidate for transplantation. 2.7.2 Pre- and post-transplantation inpatient hospital and outpatient services. 2.7.3 Pre- and postoperative services of the transplantation team. 2.7.4 The donor acquisition team, including the costs of transportation to the location of the donor organ and transportation of the team and the donated organ to the location of the transplantation center. 2.7.5 The maintenance of the viability of the donor organ after all existing legal requirements for excision of the donor organ have been met. 2.7.6 Donor costs. 2.7.7 Blood and blood products. 2.7.8 U.S. Food and Drug Administration (FDA) approved immunosuppression drugs to include off-label uses when reliable evidence documents that the off-label use is safe, effective and in accordance with nationally accepted standards of practice in the medical community (proven). (Chapter 8, Section 9.1) 2.7.9 Complications of the transplantation procedure, including inpatient care, management of infection and rejection episodes. 2.7.10 Periodic evaluation and assessment of the successfully transplanted patient. 2.7.11 Deoxyribonucleic Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing determining histocompatibility. 2.7.12 Transportation of the patient by air ambulance and the services of a certified life support attendant. 2 C-108, March 24, 2014

2.8 Orthotopic (OLT) (CPT 2 procedure code 47135) for the treatment of Acute Intermittent Porphyria in accordance with the TRICARE provisions for the treatment of rare diseases. 3.0 POLICY CONSIDERATIONS 3.1 For beneficiaries who reside in TRICARE regions but fail to obtain preauthorization for liver or LDLT, benefits may be extended if the services or supplies otherwise would qualify for benefits but for the failure to obtain preauthorization. If preauthorization is not received, the appropriate preauthorizing authority is responsible for reviewing the claims to determine whether the beneficiary s condition meets the clinical criteria for the transplantation. TRICARE Prime enrollees who failed to obtain preauthorization will be reimbursed only under POS rules. 3.2 Benefits will only be allowed for transplantations performed at a TRICARE or Medicarecertified liver transplantation center. Benefits are also allowed for transplants performed at a pediatric facility that is TRICARE-certified as a liver transplantation center on the basis that the center belongs to a pediatric consortium program whose combined experience and survival data meet the TRICARE criteria for certification. The contractor in whose jurisdiction the center is located is the certifying authority for TRICARE authorization as a liver transplantation center. Refer to Chapter 11, Section 7.1 for organ transplantation center certification requirements. 3.3 Liver transplantation will be paid under the Diagnosis Related Group (DRG). 3.4 Claims for transportation of the donor organ and transplantation team shall be adjudicated on the basis of billed charges, but not to exceed the transport service s published schedule of charges, and cost-shared on an inpatient basis. Scheduled or chartered transportation may be costshared. 3.5 Charges made by the donor hospital will be cost-shared on an inpatient basis and must be fully itemized and billed by the transplantation center in the name of the TRICARE patient. 3.6 Acquisition and donor costs are not considered to be components of the services covered under the DRG. These costs must be billed separately on a standard Centers for Medicare and Medicaid Services (CMS) 1450 UB-04 claim form in the name of the TRICARE patient. 3.7 When a properly preauthorized transplantation candidate is discharged less than 24 hours after admission because of extenuating circumstances, such as the available organ is found not suitable or other circumstances which prohibit the transplantation from being timely performed, all otherwise authorized services associated with the admission shall be cost-shared on an inpatient basis, since the expectation at admission was that the patient would remain more than 24 hours. 3.8 Liver or LDLT performed on an emergency basis in an unauthorized liver transplantation facility may be cost-shared only when the following conditions have been met: 3.8.1 The unauthorized center must consult with the nearest TRICARE or Medicare-certified liver transplantation center regarding the transplantation case; 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 3 C-146, November 25, 2015

3.8.2 It must be determined and documented by the transplantation team physician(s) at the certified liver transplantation center that transfer of the patient (to the certified liver transplantation center) is not medically reasonable, even though transplantation is feasible and appropriate; and 3.8.3 All other TRICARE contractual requirements have been met. 4.0 EXCLUSIONS 4.1 Liver transplantation and LDLT is excluded when any of the following contraindications exist: 4.1.1 Significant systemic or multisystemic disease (other than hepatorenal failure) which limits the possibility of full recovery and may compromise the function of the newly transplanted organs. 4.1.2 Active alcohol or other substance abuse that interferes with compliance to strict treatment regimen. 4.1.3 Malignancies metastasized to or extending beyond the margins of the liver. 4.2 The following are also excluded: 4.2.1 Expenses waived by the transplantation center (e.g., beneficiary/sponsor not financially liable). 4.2.2 Services and supplies not provided in accordance with applicable program criteria (i.e., part of a grant or research program; unproven procedure). 4.2.3 Administration of an unproven immunosuppressant drug that is not FDA approved or has not received approval as an appropriate off-label drug indication. 4.2.4 Pre- or post-transplantation nonmedical expenses (e.g., out-of-hospital living expenses, to include hotel, meals, privately owned vehicle for the beneficiary or family members). 4.2.5 Transportation of an organ donor. 4.3 Artificial assist devices that are not FDA approved and that are not used in compliance with FDA approved indications. 5.0 EFFECTIVE DATES 5.1 November 1, 1994, for hepatitis C. 5.2 December 1, 1996, for hepatitis B. 5.3 April 5, 2010, for OTCD. 5.4 May 29, 2012, for CTLN1. 4 C-146, November 25, 2015

5.5 February 1, 2012, For Acute Intermittent Porphyria. - END - 5 C-146, November 25, 2015