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.