2.0 POLICY
2.1 Benefits
are allowed for SI, SI/L, and MV transplantation.
Note: MV 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.
2.1.2 The contractor shall reimburse
charges for the services on a Point of Service (POS) basis, if TRICARE Prime
enrollees receive transplant-related 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 SI, SI/L, and MV 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 MV transplantation are covered
for:
2.3.1 Evaluation of a potential candidate’s
suitability for SI, SI/L, and MV 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 United States (US) 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 MV 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 MV 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 geographic area of responsibility.
Refer to
Chapter 11, Section 7.1 for organ transplant
center certification requirements.
3.3 SI, SI/L,
and MV 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 MV 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 MV 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 MV transplants.
5.3 October
4, 2000, for small intestine alone transplants for patients age
16 and older.