3.0 POLICY
3.1 Heart-lung
and single and double lung transplantation requires preauthorization.
3.2 Living donor lobar lung transplantation
requires preauthorization.
3.2.1 TRICARE
Prime enrollees 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.
3.2.2 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.
3.3 The designated
preauthorizing authority shall only use the criteria contained in
this policy when preauthorizing lung and heart-lung transplantations.
3.4 The designated preauthorizing
authority may also preauthorize advanced life support for air ambulance
and a certified advanced life support attendant for a heart-lung
or lung transplantation patient who has received preauthorization.
3.5 Affirmative Patient Selection
Criteria. Benefits are allowed for single and double lung and living donor
lobar lung transplantation when the transplant is performed at a
TRICARE or Medicare-certified lung transplant center or TRICARE-certified
pediatric consortium lung transplant center. Benefits are allowed
for heart-lung transplantation when the transplant is performed
at a TRICARE or Medicare-certified heart, lung, or heart-lung transplant
center or TRICARE-certified pediatric consortium heart, lung or
heart-lung transplantation center. The beneficiaries must meet the
following criteria:
3.5.1 Have irreversible, progressively
disabling, end-stage pulmonary or cardiopulmonary disease.
3.5.2 Have tried or considered all
other medical and surgical therapies that might have been expected
to yield both short and long-term survival comparable to that of
transplantation.
3.5.3 Have a
realistic understanding of the range of clinical outcomes that may
be encountered.
3.5.4 Demonstrate
plans for a long-term adherence to a disciplined medical regimen
are feasible and realistic.
3.6 In addition
to meeting the above patient selection criteria, the following adverse
factors must be absent or minimized:
3.6.1 Acutely
ill patients (i.e., with serious exacerbation of chronic end-stage
disease or with nonchronic end-stage disease) or those who currently
require mechanical ventilation for more than a very brief period
(because there is difficulty in adequate assessment, a propensity
for infection and likelihood for poor results).
3.6.2 Significant systemic or multi-system
disease (because the presence of multi-organ involvement limits
the possibility of full recovery and may compromise the function
of the newly transplanted organ(s)).
3.6.3 Extrapulmonary
site of infection (because of the probability of recrudescence once immunosuppression
is instituted).
3.6.4 Hepatic
dysfunction, even secondary to right ventricular failure, such as
bilirubin exceeding 2.5 mg/ml (because of hepatotoxicity of many
post-transplant medications and complications due to coagulopathies,
hepatic encepalopathy, infection, poor wound healing, and increased
postoperative mortality).
3.6.5 Renal
dysfunction, such as preoperative serum creatinine greater than
1.5 mg/dl or a 24-hour creatinine clearance less than 50 ml/min,
except that with severe pulmonary hypertension creatinine clearance
as low as 35 ml/min may be acceptable if intrinsic renal disease
is excluded. (Cyclosporine is nephrotoxic).
3.6.6 Systemic hypertension that
requires multidrug therapy for even moderate control (for example,
multidrugs to bring diastolic pressure below 105 mm Hg), either
at transplantation or at the development of end-stage heart-lung
disease (because of substantial exacerbation of hypertension with
post-transplantation drug regimen).
3.6.7 Cachexia,
even in the absence of major end organ failure (because of the significantly
less favorable survival of these patients).
3.6.8 Obesity, with weight being
an increasingly severe adverse factor as the patient exceeds by 20%
of ideal weight for height and sex (because of more difficult post-operative
mobilization and impaired diaphragmatic function, as well as the
difficulty of weight control once corticosteroid immunosuppressant
is instituted).
3.6.9 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 of excessible consumption).
3.6.10 Active cigarette smoking (abstinence
of a minimum of four months prior to transplantation is recommended).
3.6.11 Previous thoracic or cardiac
surgery or other bases for pleural adhesions may be a serious adverse
factor depending upon site of thoracotomy/sternotomy, the degree
of adhesions and the type of transplant anticipated (because of
scar tissue and the propensity for inadequately controlled bleeding).
3.6.12 Recent or current history of
gastrointestinal problems (because of common post-operative gastrointestinal
problems and hemorrhage).
3.6.13 Chronic corticosteroid therapy
that cannot be tapered and discontinued prior to transplantation
has been considered a serious adverse factor by many (because of
the increased risk of tracheal or bronchial dehiscence in the early
post-operative period).
3.6.14 With chronic pulmonary infection
(as with bronchiectasis, chronic or cystic fibrosis), single lung
transplantation is contraindicated (because of the great likelihood
of the infection extending from the contaminated native lung into
the transplanted lung) and the patient must meet the criteria and benefit/risk
considerations of double lung or heart-lung transplantation.
3.6.15 With significant heart disease
(for example, substantial irreversible right ventricular disease or
significant coronary artery disease) the patient must meet the criteria
and benefit/risk considerations for heart-lung transplantation;
lung transplantation and concurrent repair of the cardiac abnormality
may be appropriate in unusual circumstances, as in some situations
with Eisenmenger’s syndrome.
3.6.16 Primary or metastatic malignancies
of the lung.
3.7 Services
and supplies related to heart-lung or lung transplantation are covered
for:
3.7.1 Evaluation of potential candidate’s
suitability for heart-lung or lung transplantation, whether or not
the patient is ultimately accepted as a candidate for transplantation.
3.7.2 Pre- and post-transplant inpatient
hospital and outpatient services.
3.7.3 Pre- and
post-operative services of the transplant team.
3.7.4 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.
3.7.5 The maintenance
of the viability of the donor organ after all existing legal requirements
for excision of the donor organ have been met.
3.7.6 Donor costs.
3.7.7 Blood and blood products.
3.7.8 U.S. Food and Drug Administration
(FDA) approved immunosuppression drugs to include off-label uses
when reliable evidence documents that the off-label use is safe,
effective and in accordance with nationally accepted standards of
practice in the medical community (proven).
3.7.9 Complications of the transplant
procedure, including inpatient care, management of infection and
rejection episodes.
3.7.10 Periodic evaluation and assessment
of the successfully transplanted patient.
3.7.11 Cardiac rehabilitation.
3.7.12 Pulmonary rehabilitation for
pre- and post-lung and heart-lung transplants.
3.7.13 Transportation of the patient
by air ambulance and the services of a certified life support attendant.
3.7.14 Deoxyribonucleic Acid-Human
Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility.
3.8 TRICARE may cost-share for
epoprostenol (FLOLAN®) for the management of severe secondary pulmonary
hypertension, including those for patients with pulmonary hypertension
secondary to the scleroderma spectrum of diseases, whether or not
they have been authorized for and are awaiting lung transplantation.
3.9 AlloMap® molecular expression
testing for cardiac transplant rejection surveillance.
4.0 POLICY CONSIDERATION
4.1 In those cases where the beneficiary
fails to obtain preauthorization, benefits may be extended if the
services of 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-lung or lung
transplantation 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.
4.2 Benefits
will only be allowed for transplants performed at a TRICARE or Medicare-certified heart,
heart-lung or lung transplantation center. Benefits are also allowed
for transplants performed at a pediatric facility that is TRICARE-certified
as a heart, heart-lung, or lung 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.
4.3 Heart-lung,
and lung transplantation will be paid under the DRG.
4.4 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.
4.5 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.
4.6 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.
4.7 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.
4.8 Heart-lung
and lung transplants performed on an emergency basis in an unauthorized
heart-lung or lung transplant facility may be cost-shared only when
the following conditions have been met:
4.8.1 The unauthorized
center must consult with the nearest TRICARE or Medicare-certified heart-lung
or lung transplantation center regarding the transplantation case;
and
4.8.2 It must be determined and documented
by the transplant team physician(s) at the certified heart-lung
or lung transplantation center that transfer of the patient (to
the certified heart-lung or lung transplantation center) is not
medically reasonable, even though transplantation is feasible and appropriate.
5.0 EXCLUSIONS
5.1 Expenses
waived by the transplant center, (e.g., beneficiary/sponsor not
financially liable).
5.2 Services
and supplies not provided in accordance with applicable program
criteria (i.e., part of a grant or research program; unproven procedure).
5.3 Administration of an unproven
immunosuppressant drug that is not FDA approved or has not received
approval as an appropriate “off label” drug indication.
5.4 Pre- or post-transplant nonmedical
expenses, (e.g., out-of-hospital living expenses, to include hotel,
meal, privately owned vehicle for the beneficiary or family members).
5.5 Transportation of an organ
donor.