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.
