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.