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.