2.0 POLICY
2.1 Benefits
are allowed for SPK transplantation, PAK transplantation, and PTA.
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 SPK and
PAK are covered when the transplantation is performed at a Medicare-approved
renal transplantation center, for patients who:
2.2.1 Are suffering
from concomitant, Type I Diabetes Mellitus that is resistant to
exogenous therapy and end stage chronic renal disease; and
2.2.2 Have exhausted more conservative
medical and surgical treatments for Type I Diabetes Mellitus and
renal disease.
2.2.3 Have a
realistic understanding of the range of clinical outcomes that may
be encountered.
2.2.4 Plans
for long-term adherence to a disciplined medical regimen are feasible
and realistic.
2.3 PTA is
covered when performed at a Medicare approved renal transplantation
center.
2.3.1 For patients who are suffering
from labile Type I Diabetes Mellitus:
• Patient with diabetes must
be beta cell autoantibody positive; or
• Patient must demonstrate insulinopenia
defined as a fasting C-peptide level that is less than or equal
to 110% of the lower limit of normal of the laboratory’s measurement
method. Fasting C-peptide levels will only be considered valid with
a concurrently obtained fasting glucose less than or equal to 225
mg/Dl;
2.3.2 Patients
must have a history of medically-uncontrollable labile (brittle)
insulin-dependent diabetes mellitus with documented recurrent, severe,
acutely life-threatening metabolic complications that require hospitalization.
Aforementioned complications include frequent hypoglycemia unawareness
or recurring severe ketoacidosis, or recurring severe hypoglycemic
attacks;
2.3.3 Patients must have been optimally
and intensively managed by an endocrinologist for at least 12 months
with the most medically-recognized advanced insulin formulations
and delivery systems;
2.3.4 Patients
must have the emotional and mental capacity to understand the significant
risks associated with surgery and to effectively manage the lifelong
need for immunosuppression;
2.3.5 Patients
must otherwise be a suitable candidate for transplantation.
2.4 Services and supplies related
to SPK, PAK, and PTA are covered for:
2.4.1 Evaluation
of a potential candidate’s suitability for SPK, PAK, and PTA whether
or not the patient is ultimately accepted as a candidate for transplantation.
2.4.2 Pre- and post-transplantation
inpatient hospital and outpatient services.
2.4.3 Surgical services and related
pre- and postoperative services of the transplantation 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 Donor costs.
2.4.7 Blood and blood products.
2.4.8 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 the national standards of practice
in the medical community (proven). Mycophenolate Mofetil (Cellcept)
and Tacrolimus (Prograf) for the prophylaxis of organ rejection
in patients receiving SPK, PAK, and PTA are covered.
2.4.9 Complications of the transplantation
procedure, including inpatient care, management of infection and
rejection episodes.
2.4.10 Periodic evaluation and assessment
of the successfully transplanted patient.
2.4.11 Hepatitis B and pneumococcal
vaccines for patients undergoing transplantation.
2.4.12 Deoxyribonucleic Acid-Human
Leucocyte Antigen (DNA-HLA) tissue typing in determining histocompatibility.
2.4.13 Transportation of the patient
by air ambulance and the services of a certified life support attendant.
2.5 Autologous pancreatic islet
cell transplantation as an adjunct to a total or near total pancreatectomy
for the treatment of chronic pancreatitis is covered (Current Procedural
Terminology (CPT) procedure code 48160).
3.0 POLICY CONSIDERATIONS
3.1 For beneficiaries who fail
to obtain preauthorization for SPK, PAK, and PTA 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 SPK 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.
3.2 Benefits for SPK, PAK, or PTA
transplantation will only be allowed for transplants performed at
a Medicare-approved renal transplantation center.
3.3 SPK, PAK, and PTA transplantations
shall be reimbursed under the assigned Diagnosis Related Group (DRG).
3.4 Claims for transportation of
the donor organ and transplantation 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 transplantation 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 and will be reimbursed based on billed charges. 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 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 SPKs, PAKs, or PTAs performed
on an emergency basis in an unauthorized renal transplant facility
may be cost-shared only when the following conditions have been
met:
• The unauthorized center must
consult with the nearest Medicare-certified renal transplant center regarding
the transplantation case; and
• It must be determined and documented
by the transplant team physician(s) at the Medicare-approved renal
transplantation center that transfer of the patient (to a Medicare-approved
renal transplantation center) is not medically reasonable, even
though transplantation is feasible and appropriate.
4.0 EXCLUSIONS
4.1 SPK, PAK,
and PTA are excluded when any of the following contraindications
exist:
4.1.1 Significant systemic or multisystemic
disease (other than pancreatic-renal dysfunction) which limits the
possibility of full recovery and may compromise the function of
the newly transplanted organs.
4.1.2 Active
alcohol or other substance abuse.
4.1.3 Malignancies
metastasized to or extending beyond the margins of the kidney and/or pancreas.
4.1.4 Significant coronary artery
disease.
4.2 The following
are also excluded:
4.2.1 Expenses waived by the transplantation
center (e.g., beneficiary/sponsor not financially liable).
4.2.2 Services and supplies not provided
in accordance with applicable program criteria (i.e., part of a
grant or research program; unproven procedure).
4.2.3 Administration of an unproven
immunosuppressant drug that is not FDA approved or has not received
TRICARE approval as an appropriate “off-label” drug indication.
4.3 Pre- or post-transplantation
nonmedical expenses (e.g., out-of-hospital living expenses, to include
hotel, meals, privately owned vehicle for the beneficiary or family
members).
4.4 Transportation of an organ
donor.
4.5 Autologous islet cell transplantation,
when used alone, and allogeneic islet cell transplantation for the
treatment of diabetes mellitus (CPT procedure codes 0141T - 0143T
and HCPCS codes G0341 - G0343, S2102).
5.0 EFFECTIVE DATES
5.1 October
1, 1995, for SPK transplants.
5.2 January
1, 1996, for PAK and PTA transplants.
5.3 January
1, 2007, for autologous pancreatic islet cell transplantation as
an adjunct to a total or near total pancreatectomy for treatment
of chronic pancreatitis.