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Transplantation of a normal pancreas is a treatment method for patients with insulin-dependent diabetes mellitus. Pancreas transplantation can restore glucose control and is intended to prevent, halt, or reverse the secondary complications from diabetes mellitus.
Achievement of insulin independence with resultant decreased morbidity and increased quality of life is the primary health outcome of pancreas transplantation. While pancreas transplantation is generally not considered a life-saving treatment, in a small subset of patients who experience life-threatening complications from diabetes, pancreas transplantation could be considered life-saving. Pancreas transplant alone (PTA) has also been investigated in patients following total pancreatectomy for chronic pancreatitis. In addition to the immune rejection issues common to all allograft transplants, autoimmune destruction of beta cells has been observed in the transplanted pancreas, presumably from the same mechanism responsible for type 1 diabetes.
Pancreas transplantation occurs in several different scenarios such as: 1) a diabetic patient with renal failure who may receive a cadaveric simultaneous pancreas/kidney transplant (SPK); 2) a diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney, i.e., PAK); or 3) a non-uremic diabetic patient with specific severely disabling and potentially life-threatening diabetic problems who may receive a pancreas transplant alone (PTA). The total number of adult pancreas transplants (pancreas and pancreas/kidney) in the United States peaked at 1,484 in 2004; the number has since declined. In 2013, 214 PTAs and 651 SPKs were performed in the United States.
According to International Registry data, the proportion of pancreas transplant recipients worldwide who have type 2 diabetes has increased over time, from 2% in 1995 to 7% in 2010. In 2010, approximately 8% of SPK, 5% of PAK, and 1% of PTA were performed in patients with type 2 diabetes.
The approach to retransplantation varies according to the cause of failure. Surgical/technical complications such as venous thrombosis are the leading cause of pancreatic graft loss among diabetic patients. Graft loss from chronic rejection may result in sensitization, increasing both the difficulty of finding a cross-matched donor and the risk of rejection of a subsequent transplant. Each center has its own guidelines based on experience; some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.
POLICYNo benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
A combined pancreas-kidney transplant may be considered medically necessary in insulin dependent diabetic patients with uremia.
Pancreas transplant after a prior kidney transplant may be considered medically necessary in patients with insulin dependent diabetes mellitus.
Pancreas transplant alone may be considered medically necessary in patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists in spite of optimal medical management.
Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary in patients who meet criteria for pancreas transplantation.
Pancreas transplant is considered investigational in all other situations.
POLICY EXCEPTIONSPatients with peripheral neuropathy and severely disabling and potentially life-threatening complications due to Type I diabetes that persists in spite of optimal medical management will be considered on an individual basis for a solitary pancreas transplant. These potential candidates for pancreas transplant alone (PTA) should have documentation of potentially life-threatening labile diabetes as evidenced by chart notes or hospitalization for diabetic ketoacidosis.
The determination will be made through the peer review process (which includes, but is not limited to the review of peer reviewed literature, second opinions and administrative policy in existence at the time of the request for the procedure).
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Candidates for pancreas transplant alone should additionally meet 1 of the following severity of illness criteria:
In addition, the vast majority of pancreas transplant patients will have type 1 diabetes mellitus. Those transplant candidates with type 2 diabetes mellitus, in addition to being insulin-dependent, should also not be obese (body mass index [BMI] should be 32 or less).
Although there are no standard guidelines regarding multiple pancreas transplants, the following information may aid in case review:
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
2/14/2002: Investigational definition added, table added to Code Reference section
5/2/2002: Type of Service and Place of Service deleted
10/18/2005: Policy section updated; "Absence of HIV infection" deleted; added "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients (7/21/2005)"; Code Reference table updated: CPT codes 48551, 48552, 48556 added; ICD-9 procedure code 00.93 added; HCPCS codes S2065, S2152 added; diagnosis codes 250-250.92, V58.67 added, 250.11, 250.13, 250.21, 250.23, 250.31, 250.41, 250.43, 250.51, 250.61, 250.63, 250.71, 250.73, 250.81, 250.83, 251.0, 251.1, 251.2 deleted.
11/8/2005: Code Reference section updated, 4th digit added to ICD9 diagnosis codes 585.1 - 585.9; description revised
3/13/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
10/23/2006: Policy reviewed, policy section re-written for clarity
2/22/2008: Removed the following policy statement: "Pancreas retransplant after 2 or more prior failed pancreas transplants is considered investigational." No other changes made to policy statements. Code Reference section reviewed. Removed ICD-9 codes 250.00, 250.02, 250.50, 250.52, 250.60, 250.62, 250.70, and 250.72. Added ICD-9 codes 250.11, 250.13, 250.21, 250.23, 250.31, 250.33, 250.41, 250.43, 250.81, 250.83, 250.91, 250.93, and 996.86. "Allogeneic" added to policy title
12/31/2008: Policy reviewed, prior authorization for evaluation removed.
05/09/2011: Policy description updated regarding the number and success of pancreas tranplants. "Insulin dependent" added to the first policy statement. Policy statement added to state when pancreas transplant is considered not medically necessary. Policy guidelines updated regarding candidates for pancreas transplant.
05/08/2012: Deleted the not medically necessary policy statement, which stated the following: Pancreas transplant is considered not medically necessary in patients with the following conditions: 1. Known current malignancy, including metastatic cancer; 2. Recent malignancy with high risk of recurrence; 3. Untreated systemic infection making immunosuppression unsafe, including chronic infection; or 4. Other irreversible end-stage disease not attributed to kidney or pancreatic disease. "Insulin dependent" added to the third policy statement. Policy guidelines updated regarding contraindications to tranplant.
04/16/2013: Policy reviewed; no changes.
03/17/2014: Policy reviewed; no changes.
03/16/2015: Policy description updated to add pancreas transplant alone (PTA) information. Medically necessary statement revised to state that a pancreas retransplant after a failed primary pancreas transplant may be considered medially necessary in patients who meet criteria for pancreas transplantation. Added the following statement: Pancreas transplant is considered investigational in all other situations.
08/25/2015: Code Reference section updated for ICD-10.
06/01/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)TEC Assessments 1998: TBD
Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy #7.03.02
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.