1.0 POLICY
1.1 CHKT
is a TRICARE benefit that requires preauthorization.
1.1.1 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.
1.1.2 For non-enrolled TRICARE beneficiaries
residing in a Managed Care Support (MCS) region, preauthorization
authority is the responsibility of the MCS Medical Director or other
designated utilization staff.
1.2 The designated preauthorizing
authority shall only use the criteria contained in this policy when
preauthorizing simultaneous heart-kidney transplantation.
1.3 CHKT is
covered when the transplantation is performed at a center certified
by TRICARE or Medicare for heart transplantation or TRICARE-certified
pediatric consortium heart transplantation center and Medicare-approved
for renal transplantation, for patients who:
1.3.1 Are suffering from end stage
heart disease and irreversible or end stage renal disease; and
1.3.2 Have exhausted
more conservative medical and surgical treatments.
1.3.3 Have a
realistic understanding of the range of clinical outcomes that may
be encountered.
1.3.4 Plans for long-term adherence
to a disciplined medical regimen are feasible and realistic.
1.4 Services
and supplies related to CHKT are covered for:
1.4.1 Evaluation of a potential
candidate’s suitability for transplantation whether or not the patient
is ultimately accepted as a candidate for transplantation.
1.4.2 Pre- and
post-transplantation inpatient hospital and outpatient services.
1.4.3 Surgical
services and related pre- and postoperative services of the transplantation
team.
1.4.4 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.
1.4.5 The maintenance of the viability of the donor
organ after all existing legal requirements for excision of the
donor organ have been met.
1.4.6 Donor costs.
1.4.7 Blood and
blood products.
1.4.8 U.S. Food and Drug Administration
(FDA) approved immunosuppression drugs to include off-label uses
when determined to be medically necessary and generally accepted
practice within the general medical community (i.e., proven).
1.4.9 Complications
of the transplantation procedure, including inpatient care, management
of infection and rejection episodes.
1.4.10 Periodic
evaluation and assessment of the successfully transplanted patient.
1.4.11 Hepatitis
B and pneumococcal vaccines for patients undergoing transplantation
are covered under TRICARE.
1.4.12 Deoxyribonucleic
Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility
are covered under TRICARE.
1.4.13 Transportation
of the patient by air ambulance and the services of a certified
life support attendant.
1.4.14 AlloMap®
molecular expression testing for cardiac transplant rejection surveillance.
2.0 POLICY
CONSIDERATIONS
2.1 For beneficiaries who fail to obtain preauthorization
for CHKT, TRICARE benefits may be extended if the services or supplies
otherwise would qualify for coverage but for the failure to obtain preauthorization.
If preauthorization is not received, the appropriate preauthorizing
authority as outlined in
paragraph 1.1, is responsible for reviewing
the claims to determine whether the beneficiary’s condition meets
the clinical criteria for the CHKT 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.
2.2 Benefits will only be allowed
for transplants performed at a center that is TRICARE or Medicare-certified
for heart transplantation and Medicare-approved for renal transplantation.
Benefits are also allowed for transplants performed at a pediatric
facility that is TRICARE-certified as a heart 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.
2.3 Effective August 1, 2003,
CHKTs shall be paid under the assigned DRG based on the patient’s diagnosis.
Claims for admissions prior to August 1, 2003 shall be reimbursed
based on billed charges.
2.4 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.
2.5 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.
2.6 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.
2.7 When a properly preauthorized
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 transplant
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.
2.8 Combined heart-kidney transplants performed
on an emergency basis in an unauthorized renal and heart transplant
facility may be cost-shared by TRICARE only when the following conditions have
been met:
2.8.1 The unauthorized center must consult with the
nearest center that is TRICARE or Medicare-certified for heart transplantation
and Medicare-approved for renal transplantation regarding the transplantation
case; and
2.8.2 It must be determined and documented by the
transplant team physician(s) at the center that is TRICARE or Medicare
certified for heart transplantation and Medicare-approved for renal transplantation
that transfer of the patient (to a center that is TRICARE or Medicare-certified
for heart transplantation and Medicare-approved for renal transplantation)
is not medically reasonable, even though transplantation is feasible
and appropriate.
3.0 EXCLUSIONS
3.1 CHKT is
excluded when any of the following contraindications exist:
3.1.1 Severe
pulmonary hypertension (pulmonary vascular resistance above 5 Wood
units or pulmonary artery systolic pressure over 65 mm Hg) not reversible
with intravenous agents.
3.1.2 Active infection.
3.1.3 Human Immunodeficiency
Virus (HIV) positivity.
3.1.4 Active alcohol or other substance
abuse including current use of tobacco (verified abstinence for
six months is mandatory).
3.1.5 Active malignant disease.
3.1.6 Hepatic
dysfunction not explained by the underlying heart failure and not
deemed reversible.
3.1.7 Symptomatic or asymptomatic
cerebrovascular disease.
3.1.8 Systemic hypertension, either
at transplantation or prior to development of end stage cardiac
disease, that is not controlled, even with multi-drug therapy.
3.1.9 History
of noncompliance or psychiatric illness of such magnitude as to
jeopardize postoperative compliance.
3.1.10 Recent
and unresolved pulmonary infarction or undiagnosed pulmonary nodules.
3.1.11 Any chronic
systemic illness that will limit or preclude survival and rehabilitation
after transplantation.
3.1.12 Current
or recent history of diverticulitis or current peptic ulcer disease
require evaluation by a gastroenterology specialist prior to determining
candidacy.
3.2 Expenses waived by the transplantation
center (e.g., beneficiary/sponsor not financially liable).
3.3 Services
and supplies not provided in accordance with applicable program
criteria (i.e., part of a grant or research program; unproven procedure).
3.4 Administration
of an unproven immunosuppressant drug that is not FDA approved or
has not received TRICARE approval as an appropriate “off-label”
drug indication.
3.5 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).
3.6 Transportation of an organ donor.