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.