2.0 POLICY
2.1 Benefits
are allowed for heart transplantation.
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 Benefits
are allowed for heart transplantation when the transplant is performed
at a TRICARE or Medicare-certified heart transplant center or TRICARE-certified
pediatric consortium heart transplantation center, for beneficiaries
who:
2.2.1 Have an end-stage cardiac disease
who have exhausted alternative medical and surgical treatments;
and
2.2.2 Have a very poor prognosis
as a result of poor cardiac functional status; and
2.2.3 For whom plans for long-term
adherence to a disciplined medical regimen are feasible.
2.3 In addition to meeting the
above patient selection criteria, the following adverse factors
must be absent or minimized:
2.3.1 Advancing
age (because of diminished capacity to withstand postoperative complications). The
selection of any patients for transplantation beyond age 50 must
be done with particular care to ensure an adequately young physiologic
age and the absence or insignificance of coexisting disease.
2.3.2 Severe pulmonary hypertension
(because of the limited work capacity of the typical donor right
ventricle). A pulmonary vascular resistance above 5 Wood units or
pulmonary artery systolic pressure over 65 mm Hg is considered to
be severe pulmonary hypertension.
2.3.3 Renal
or hepatic dysfunction not explained by the underlying heart failure
and not deemed reversible (because of the nephrotoxicity and hepatotoxicity
of cyclosporin).
2.3.4 Acute
severe hemodynamic compromise at the time of transplantation if
accompanied by compromise or failure of a vital end-organ (because
of a substantially less favorable prognosis for survival than for
the average transplant recipient).
2.3.5 Symptomatic
peripheral or cerebrovascular disease (because of accelerated progression
in some patients after cardiac transplantation and chronic corticosteroid
treatment).
2.3.6 Chronic obstructive pulmonary
disease or chronic bronchitis (because of poor postoperative course
and likelihood of exacerbation of infection with immunosuppression).
2.3.7 Active systemic infection (because
of the likelihood of exacerbation with initiation of immunosuppression).
2.3.8 Recent and unresolved pulmonary
infarction or pulmonary roentgenographic evidence of infection or
of abnormalities of unclear etiology (because of the likelihood
that this represents pulmonary infection).
2.3.9 Systemic
hypertension, either at transplantation or prior to development
of end-stage cardiac disease, that requires multi-drug therapy for
even moderate control (multi-drugs to bring diastolic pressure below
105 mm Hg). Other systemic disease considered likely to limit or
preclude survival and rehabilitation after transplantation.
2.3.10 Cachexia, even in the absence
of major end-organ failure (because of the significantly less favorable
survival of such patients).
2.3.11 The need for or prior transplantation
of a second organ such as lung, liver, kidney, or marrow (because
this represents the coexistence of significant disease).
2.3.12 A history of a behavior pattern
or psychiatric illness considered likely to interfere significantly
with compliance with a disciplined medical regimen (because a lifelong
medical regimen is necessary, requiring multiple drugs several times
a day, with serious consequences in the event of their interruption
or excessive consumption).
2.3.13 The use of a donor heart, the
long-term effectiveness of which might be compromised by such actions
as the use of substantial vasopressors prior to its removal from
the donor, its prolonged or compromised maintenance between the
time of its removal from the donor and its implantation into the
patient, or pre-existing disease.
2.3.14 Insulin-requiring diabetes
mellitus (because the diabetes is often accompanied by occult vascular
disease and because the diabetes and its complications are exacerbated
by chronic corticosteroid therapy).
2.3.15 Asymptomatic severe peripheral
or cerebrovascular disease (because of accelerated progression in
some patients after cardiac transplantation and chronic corticosteroid
treatment).
2.3.16 Peptic ulcer disease (because
of the likelihood of early postoperative exacerbation); and
2.3.17 Current or recent history of
diverticulitis (considered as a source of active infection which may
be exacerbated with the initiation of immunosuppressant therapy).
2.4 Services and supplies related
to heart transplantation are covered for:
2.4.1 Evaluation
of a potential candidate’s suitability for heart transplantation
whether or not the patient is ultimately accepted as a candidate
for transplantation.
2.4.2 Pre- and
post-transplant inpatient hospital and outpatient services.
2.4.3 Pre- and post-operative services
of the transplant team.
2.4.4 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.
2.4.5 The maintenance of the viability
of the donor organ after all existing legal requirements for excision
of the donor organ have been met.
2.4.6 Blood
and blood products.
2.4.7 U.S. Food
and Drug Administration (FDA) approved immunosuppression drugs to
include off-label uses when reliable evidence documents the off-label
use is safe, effective, and provided in accordance with nationally
accepted standards of practice in the medical community (proven).
2.4.8 Complications of the transplant
procedure, including inpatient care, management of infection and
rejection episodes.
2.4.9 Periodic
evaluation and assessment of the successfully transplanted patient.
2.4.10 Cardiac rehabilitation.
2.4.11 Deoxyribonucleic Acid-Human
Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility.
2.4.12 Donor costs.
2.4.13 Transportation of the patient
by life support air ambulance and the services of a certified life
support attendant.
2.5 Ventricular
assist devices are covered if the device is FDA approved and used
in accordance with FDA approved indications.
2.6 The SynCardia temporary Total
Artificial Heart (TAH) for the treatment of end-stage biventricular
heart failure is covered when used as a bridge to heart transplantation.
2.7 TAHs as destination therapy
may be covered if the device has received a Humanitarian Device Exemption
(HDE) from the FDA, and the device is used in accordance with FDA
approved indications. See
Chapter 8, Section 5.1 for the policy regarding
HDEs.
2.8 AlloMap®
molecular expression testing for cardiac transplant rejection surveillance.
3.0 POLICY CONSIDERATIONS
3.1 For beneficiaries who reside
in TRICARE regions but fail to obtain preauthorization for heart transplantation,
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
heart transplant. 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 or Medicare
approved heart transplantation center. 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
in whose jurisdiction the center is located is the certifying authority
for TRICARE authorization as a heart transplantation center. Refer
to
Chapter 11, Section 7.1 for organ transplant
center certification requirements.
3.3 Heart
transplantation will be paid under the Diagnosis Related Group (DRG).
3.4 Claims for transportation of
the donor organ and transplant 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 transplant 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. 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 transplant 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.
3.8 Heart
transplantations performed on an emergency basis in an unauthorized
heart transplant 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 or Medicare-approved center
regarding the transplantation case; and
3.8.2 It must
be determined and documented by the transplant team physician(s)
at the approved center that transfer of the patient (to the approved
center) is not medically reasonable, even though transplantation
is feasible and appropriate.
4.0 EXCLUSIONS
4.1 Expenses
waived by the transplant center (e.g., beneficiary/sponsor not financially
liable).
4.2 Services and supplies not provided
in accordance with applicable program criteria (i.e., part of a grant
or research program; unproven procedure).
4.3 Administration
of an unproven immunosuppressant drug that is not FDA approved or
has not received approval as an appropriate “off-label” drug indication.
4.4 Pre- or post-transplant nonmedical
expenses (e.g., out-of-hospital living expenses, to include hotel,
meals, privately owned vehicle for the beneficiary or family members).
4.5 Transportation of an organ
donor.
4.6 Prolonged extracorporeal circulation
for cardiopulmonary insufficiency (CPT procedure codes 33960 and
33961).
5.0 EFFECTIVE DATES
5.1 November
7, 1986, for heart transplants.
5.2 The date
of FDA approval for ventricular assist devices.
5.3 July 18, 2005, for the SynCardia
temporary TAH as a bridge to heart transplantation.
5.4 The date of FDA approval for
TAHs as destination therapy.
5.5 February
19, 2015, for AlloMap® molecular expression testing for cardiac
transplant rejection surveillance.