2.0 POLICY
2.1 Benefits
are allowed for liver and Living Donor Liver Transplantations (LDLT).
2.1.1 A TRICARE
Prime enrollee must have a referral from their 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, contractors 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 (through
December 31, 2017) and TRICARE Select enrollees (starting January
1, 2018) 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 Medicare-certified 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.
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.
2.8 Orthotopic Liver Transplantation
(OLT) (CPT 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 Medicare-certified 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 cost-shared.
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;
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.
5.5 February 1, 2012, for Acute
Intermittent Porphyria.