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.
2.1.2 The contractor shall reimburse
charges for the services on a Point of Service (POS) basis, if Prime enrollees
receive health care services from non-network civilian providers
without the required PCM referral and contractor authorization.
Special cost-sharing requirements apply to POS claims.
2.1.3 The contractor shall be the
preauthorization authority for TRICARE Standard and TRICARE Extra patients
(through December 31, 2017) and TRICARE Select enrollees (starting
January 1, 2018) residing in its geographic area of responsibility.
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 United States (US) 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) (Current Procedural Terminology (CPT) 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 geographic areas of responsibility 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.