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.;
and
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 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.
2.8 Liver transplantation
may be covered for unresectable/nonresectable Colorectal Cancer
(CRC) with Liver Metastases (LM), if prior authorization and tumor
board approval are obtained, and all inclusion criteria in paragraph 2.8.1 are
met, and all exclusion criteria in paragraph 2.8.2 are absent:2.8.1 Inclusion criteria for
liver transplantation for CRC with LM:
• Unresectable CRC with
LM contained solely within the liver;
• Resection of primary
tumor with clear resection margins;
• Favorable biological
response to chemotherapy and bridging therapy to transplantation
for at least six months and imaging stability/response for at least
three months during last systemic line; and
• Patient-specific expected
five-year survival greater than 50%.
2.8.2 Exclusion criteria for
liver transplantation for CRC with LM:
• Primary tumor histology
of undifferentiated adenocarcinoma and signet ring cell carcinoma;
• Metabolic tumor volume
of >70 cubic centimeters and total lesion glycolysis of >260 grams;
• N2 nodal disease of
the primary tumor, except for patients with late metachronous non-resectable
colorectal LM without nodal recurrence.
• Extrahepatic or extracolonic
metastases or extrahepatic metastatic disease;
• Having known syndromes
associated with CRC (e.g., Lynch Syndrome, BRAF V600E variant);
• Microsatellite instability-high
or mismatch repair deficient metastatic CRC; and
• Carcinoembryonic antigen
(CEA) >80 micrograms per liter with an increasing trend or CEA >80
micrograms per liter without other favorable biologic factors; radiological
or biochemical evidence of cancer progression.
2.8.3 Prior to patient referral
to transplant centers for liver transplantation for CRC with LM,
contractors should ensure that the determination of unresectable
or nonresectable be made by a military or private sector multi-disciplinary
cancer conference such as the Murtha Cancer Center at Walter Reed
National Military Medical Center, when possible.
2.9 Services and supplies related
to liver and LDLTs are covered for:
2.9.1 Evaluation of a potential candidate’s
suitability for liver transplantation whether or not the patient
is ultimately accepted as a candidate for transplantation.
2.9.2 Pre- and post-transplantation
inpatient hospital and outpatient services.
2.9.3 Pre- and postoperative services
of the transplantation team.
2.9.4 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.
2.9.5 The maintenance of the viability
of the donor organ after all existing legal requirements for excision
of the donor organ have been met.
2.9.6 Donor costs.
2.9.7 Blood and blood products.
2.9.8 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)
2.9.9 Complications of the transplantation
procedure, including inpatient care, management of infection and
rejection episodes.
2.9.10 Periodic evaluation and assessment
of the successfully transplanted patient.
2.9.11 Deoxyribonucleic Acid-Human
Leucocyte Antigen (DNA-HLA) tissue typing determining histocompatibility.
2.9.12 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
, except
in cases of unresectable CRC with LM as described in paragraph 2.8.
4.1.4 Unresectable CRC with
LM in patients who do not meet the inclusion criteria in paragraph 2.8.1 or
who meet any of the exclusion criteria in paragraph 2.8.2.
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.
5.6 September 21, 2024,
for unresectable CRC with LM.
