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.
2.1.2 The contractor shall reimburse
charges for the services on a Point of Service (POS) basis, if TRICARE Prime
enrollees receive transplant-related services from non-network civilian
providers without the required PCM referral and contractor authorization.
Special cost-sharing requirements apply to POS claims.
2.1.3 The contractor shall be the
preauthorization authority for TRICARE Standard and TRICARE Extra patients
(through December 31, 2017) and TRICARE Select enrollees (starting
January 1, 2018) residing in its geographic area of responsibility.
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 United
States (US) 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 geographic areas of responsibility 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 (Current Procedural Terminology (CPT)
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.