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.