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.