2.0 POLICY
2.1 Benefits
are allowed for SI, SI/L, and multivisceral transplantation.
Note: Multivisceral transplantation
includes the en bloc graft of the stomach, pancreaticoduodenal complex,
and small intestine. The liver is included for patients with irreversible liver
disease. The kidney(s) is included for patients with renal failure.
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 transplant-related 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 authority is
the responsibility of the MCS Medical Director or other designated
utilization staff.
2.2 SI, SI/L,
and multivisceral transplantation are covered for pediatric and
adult patients who meet the following criteria:
2.2.1 Are suffering
from irreversible intestinal failure. Intestinal failure is defined
as the loss of absorptive capacity of the small bowel secondary
to severe, primary gastrointestinal disease or surgically-induced
short bowel syndrome.
2.2.2 Have failed
Total Parenteral Nutrition (TPN). Indicators of failed TPN are liver
failure, thrombosis, frequency of infection, and dehydration as
demonstrated in the following clinical situations:
• Impending or overt liver failure
due to TPN induced liver injury.
• Thrombosis of the major central
venous channels, jugular, subclavian, and femoral veins.
• Frequent line infection and
sepsis.
• Frequent episodes of severe
dehydration despite intravenous fluid supplement in addition to
TPN.
2.2.3 Pediatric
patients have a parent or legal guardian who have a realistic understanding
of the range of clinical outcomes that may be encountered for pediatric
patients. Adult patients have a realistic understanding of the range
of clinical outcomes that may be encountered.
2.2.4 Plans for long-term adherence
to a disciplined medical regimen are feasible and realistic.
2.2.5 The transplant is performed
at a TRICARE-certified SI transplantation center or TRICARE-certified
pediatric consortium SI transplantation center or Medicare-certified
SI transplantation center.
2.3 Services
and supplies related to SI, SI/L, and multivisceral transplantation
are covered for:
2.3.1 Evaluation of a potential candidate’s
suitability for SI, SI/L, and multivisceral transplantation whether
or not the patient is ultimately accepted as a candidate for transplantation.
2.3.2 Pre- and post-transplantation
inpatient hospital and outpatient services.
2.3.3 Surgical services and related
pre- and postoperative services of the transplantation team.
2.3.4 Blood and blood products.
2.3.5 U.S. Food and Drug Administration
(FDA) approved immunosuppression drugs to include off-label uses
when determined to be medically necessary for the treatment of the
condition for which it is administered, according to accepted standards
of medical practice.
2.3.6 Complications
of the transplant procedure, including inpatient care, management
of infection and rejection episodes.
2.3.7 Periodic
evaluation and assessment of the successfully transplanted patient.
2.3.8 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.
2.3.9 The maintenance
of the viability of the donor organ after all existing legal requirements
for excision of the donor organ have been met.
2.3.10 Donor costs.
2.3.11 Hepatitis B and pneumococcal
vaccines for patients undergoing transplantation.
2.3.12 Deoxyribonucleic Acid-Human
Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility.
2.3.13 Transportation of the patient
by air ambulance and the services of a certified life support attendant.
3.0 POLICY CONSIDERATIONS
3.1 For beneficiaries who fail
to obtain preauthorization for SI, SI/L, or multivisceral transplantation, TRICARE
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
SI, SI/L, or multivisceral transplantation benefit. Charges for transplant
and transplant-related services provided to TRICARE Prime enrollees
who failed to obtain PCM referral and contractor authorization will
be reimbursed only under POS rules.
3.2 Benefits
will only be allowed for transplants performed at a TRICARE-certified
SI or Medicare-certified SI transplantation center. Benefits are
also allowed for transplants performed at a pediatric facility that
is TRICARE-certified as an SI 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 is the certifying authority for transplant
centers within its region. Refer to
Chapter 11, Section 7.1 for organ transplant
center certification requirements.
3.3 SI, SI/L,
and multivisceral transplantations shall be reimbursed under the
assigned Diagnosis Related Group (DRG) based on the patient’s diagnosis.
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 and will be reimbursed based on billed charges. 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 SI, SI/L, or multivisceral
transplants performed on an emergency basis in an unauthorized SI 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-certified or Medicare-certified
SI transplantation center regarding the transplantation case; and
3.8.2 It must be determined and documented by
the transplant team physician(s) at the certified SI transplantation
center that transfer of the patient (to the certified SI transplantation
center) is not medically reasonable, even though transplantation
is feasible and appropriate.
4.0 EXCLUSIONS
4.1 SI, SI/L,
or multivisceral transplantation is excluded when any of the following
contraindications exist:
4.1.1 Ability
to ingest oral nutrition.
4.1.2 Serious,
uncontrolled psychiatric illness that would hinder compliance with
any stage of the transplant process.
4.1.3 Significant
cardiopulmonary insufficiency.
4.1.4 History
or presence of aggressive and/or incurable malignancy.
4.1.5 Persistent abdominal or systemic
infection.
4.1.6 Severe autoimmune disease.
4.1.7 Severe immunodeficiency disease.
4.1.8 Active alcohol or chemical
dependency that interferes with compliance to strict treatment regimen.
4.1.9 Inability or unwillingness
of the patient or legal guardian to give signed consent and to comply
with regular follow-up requirements.
4.2 Also excluded are:
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.
5.0 EFFECTIVE DATES
5.1 January
1, 1996, for small intestine alone transplants for patients under
the age of 16 and combined small intestine-liver transplants for
pediatric and adult patients.
5.2 February
1, 1998, for multivisceral transplants.
5.3 October
4, 2000, for small intestine alone transplants for patients age
16 and older.