sign in sign up
<<
Home , Pancreas transplantation

Medical Policy Allogeneic Transplant

Table of Contents  Policy: Commercial  Coding Information  Information Pertaining to All Policies  Policy: Medicare  Description  References  Authorization Information  Policy History

Policy Number: 328 BCBSA Reference Number: 7.03.02

Related Policies  Kidney Transplant, #196  Islet Transplantation, #324

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity A combined pancreas-kidney transplant may be MEDICALLY NECESSARY in insulin dependent diabetic patients with uremia.

Pancreas transplant after a prior kidney transplant may be MEDICALLY NECESSARY in patients with insulin dependent .

Pancreas transplant alone may be MEDICALLY NECESSARY in patients with severely disabling and potentially life-threatening complications due to unawareness and labile insulin-dependent diabetes that persists in spite of optimal medical management.

Pancreas retransplant after a failed primary pancreas transplant may be MEDICALLY NECESSARY in patients who meet criteria for pancreas transplantation.

In addition to the above information, we do not cover pancreas transplantation when any of the following conditions are present:  Known current malignancy, including metastatic cancer  Recent malignancy with high risk of recurrence o Note: the assessment of risk of recurrence for a previously treated malignancy is made by the transplant team; providers must submit a statement with an explanation of why the patient with a recently treated malignancy is an appropriate candidate for a transplant.

1  Untreated systemic making unsafe, including chronic infection  Other irreversible end-stage disease not attributed to kidney disease  History of cancer with a moderate risk of recurrence  Systemic disease that could be exacerbated by immunosuppression  Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Candidates for pancreas transplant alone should additionally meet 1 of the following severity of illness criteria:  Documentation of severe hypoglycemia unawareness as evidenced by chart notes or emergency department visits; OR  Documentation of potentially life-threatening labile diabetes, as evidenced by chart notes or hospitalization for diabetic ketoacidosis.

In addition, most pancreas transplant patients will have 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).

Medicare HMO BlueSM and Medicare PPO BlueSM Members Nationally Covered Indications Effective for services performed on or after July 1, 1999, whole organ pancreas transplantation is nationally covered by Medicare when performed simultaneous with or after a kidney transplant. If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy begins with the date of discharge from the inpatient stay for the pancreas transplant.

Effective for services performed on or after April 26, 2006, pancreas transplants alone (PA) are reasonable and necessary for Medicare beneficiaries in the following limited circumstances: 1. PA will be limited to those facilities that are Medicare-approved for . (Approved centers can be found at http://www.cms.gov/Medicare/End-Stage-Renal- Disease/ESRDNetworkOrganizations/index.html) 2. Patients must have a diagnosis of type I diabetes:  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 ≤ 225 mg/dL; 3. 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; 4. 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; 5. 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; and, 6. Patients must otherwise be a suitable candidate for transplantation.

Nationally Non-Covered Indications Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial (see section 260.3.1 of the National Coverage Determinations Manual).

2 National Coverage Determination (NCD) for Pancreas Transplants (260.3) http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=107&ncdver=3&SearchType=Advanced&CoverageSelection=Both&NCSelection=N CD&PolicyType=Final&s=24&Cntrctr=205*1%7c208*1&KeyWord=pancreas+transplantation&KeyWordLo okUp=Doc&KeyWordSearchType=Or&ICD=52.80&kq=true&bc=IAAAABAAAAAA&

Prior Authorization Information Pre-service approval is required for all inpatient services for all products. See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient Commercial Managed Care (HMO and POS) NA Commercial PPO and Indemnity NA Medicare HMO BlueSM NA Medicare PPO BlueSM NA

CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes CPT codes: Code Description 48554 Transplantation of pancreatic allograft

HCPCS Codes HCPCS codes: Code Description S2065 Simultaneous pancreas kidney transplantation

ICD-9 Procedure Codes ICD-9-CM procedure codes: Code Description 52.80 Pancreatic transplant, not otherwise specified 52.81 Reimplantation of pancreatic tissue 52.83 Heterotransplant of pancreas

ICD-10 Procedure Codes ICD-10-PCS procedure Code Description

3 codes: 0FYG0Z0 Transplantation of Pancreas, Allogeneic, Open Approach 0FSG0ZZ Reposition Pancreas, Open Approach 0FSG4ZZ Reposition Pancreas, Percutaneous Endoscopic Approach

Description Achievement of insulin independence with resultant decreased morbidity and increased quality of life is the primary health outcome of pancreas transplantation. Pancreas transplantation can restore glucose control and is intended to prevent, halt, or reverse the secondary complications of type 1 diabetes mellitus. While pancreas transplantation is generally not considered a life-saving treatment, in a small subset of patients who experience life-threatening complications from type 1 diabetes, pancreas transplantation could be considered life-saving. Pancreas transplant alone has also been investigated in patients following total for chronic .

Simultaneous pancreas/kidney transplants are done most often because of the immunosuppression required post transplant and the side effects incurred upon each individual organ if already in a compromised state. Many physicians are reluctant to transplant a pancreas alone for diabetes without renal failure feeling that the side effects of the immunosuppressant drugs are more detrimental than the complications of diabetes. Pancreas transplantation occurs in several different scenarios such as: 1) a type 1 diabetic patient with renal failure who may receive a cadaveric simultaneous pancreas/kidney transplant (SPK); or 2) a type 1 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 type 1 diabetic patient with specific severely disabling and potentially life-threatening diabetic problems who may receive a PTA. The experience with SPK transplants is more extensive than that of other transplant options. After the double transplant is performed, there is an 80 percent to 85 percent chance that the patient will require no insulin and no dialysis for one year. In addition, there is a 70 percent chance that this success will continue over the next five years. The results from a pancreas transplant alone are very similar.

The approach to retransplantation varies according to the cause of failure. Surgical/technical complications such as venous are the leading cause of pancreatic 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.

Summary The literature, primarily consisting of case series and registry data, demonstrate graft survival rates comparable to other solid organ transplants, as well as attendant risks associated with the immunosuppressive therapy necessary to prevent allograft rejection. Recent papers highlight research in the areas of surgical technique, immunosuppressive regimens, and cellular-based alternative therapies. No randomized controlled trials compare any form of pancreas transplant to insulin therapy; the PANCREAS trial (NCT01067950) is currently recruiting patients to compare isolated pancreas transplant to intensive insulin therapy in nonuremic diabetic patients with poorly controlled diabetes. Pancreas transplant may be considered medically necessary in patients who are undergoing, or have undergone, kidney transplantation for renal failure. It may also be considered medically necessary as a stand-alone treatment in patients with hypoglycemia unawareness and labile diabetes despite optimal medical therapy and in whom severe complications have developed. Pancreas transplantation is not medically necessary in patients in whom the procedure is expected to be futile due to comorbid disease or in whom post- transplantation care is expected to significantly worsen comorbid conditions.

4 Policy History Date Action 10/2014 Medical policy remediation: New indications for non-coverage. Coding information clarified. Effective 10/1/2014. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 4/2014 BCBSA National medical policy review. Medically necessary indications clarified. Effective 4/1/2014. Coding information clarified 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 No changes to policy statements. 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and . No changes to policy statements. 5/2011 BCBSA National medical policy review. Changes to policy statements. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 11/2009 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 6/2009 BCBSA National medical policy review. No changes to policy statements. 11/2008 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 4/2008 BCBSA National medical policy review. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References 1. Hirshberg B. The cardinal features of recurrent autoimmunity in simultaneous pancreas-kidney transplant recipients. Curr Diab Rep 2010; 10(5):321-2. 2. and Transplantation Network (OPTN). Available online at: http://optn.transplant.hrsa.gov/latestData/viewDataReports.asp. Last accessed January, 2014. 3. Gruessner AC. 2011 update on pancreas transplantation: Comprehensive trend analysis of 25,000 cases followed up over the course of twenty-four years at the International Pancreas Transplant Registry. Rev Diabet Stud 2011; 8(1):6-16. 4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Transplantation. TEC Assessments 1998; Volume 13, Tab 7. 5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Retransplantation. TEC Assessments 2001; Volume 16, Tab 23. 6. Fridell JA, Mangus RS, Hollinger EF et al. The case for pancreas after kidney transplantation. Clin Transplant 2009; 23(4):447-53.

5 7. Bazerbachi F, Selzner M, Marquez MA et al. Pancreas-After-Kidney Versus Synchronous Pancreas- Kidney Transplantation: Comparison of Intermediate-Term Results. Transplantation 2012. 8. Kleinclauss F, Fauda M, Sutherland DE et al. Pancreas after living donor kidney transplants in diabetic patients: impact on long-term kidney graft function. Clin Transplant 2009; 23(4):437-46. 9. Gruessner AC, Sutherland DE, Gruessner RW. Long-term outcome after pancreas transplantation. Curr Opin Organ Transplant 2012; 17(1):100-5. 10. Mora M, Ricart MJ, Casamitjana R et al. Pancreas and kidney transplantation: long-term endocrine function. Clin Transplant 2010; 24(6):E236-40. 11. van Dellen D, Worthington J, Mitu-Pretorian OM et al. Mortality in diabetes: pancreas transplantation is associated with significant survival benefit. Nephrol Dial Transplant 2013; 28(5):1315-22. 12. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic patients. Clin J Am Soc Nephrol 2011; 6(5):1198-206. 13. Scalea JR, Butler CC, Munivenkatappa RB et al. Pancreas transplant alone as an independent risk factor for the development of renal failure: a retrospective study. Transplantation 2008; 86(12):1789- 94. 14. Buron F, Thaunat O, Demuylder-Mischler S et al. Pancreas Retransplantation: A Second Chance for Diabetic Patients? Transplantation 2013; 95(2):347-52. 15. Organ Procurement and Transplantation Network (OPTN). Identification of Transmissible Diseases in Organ Recipients. Available online at: http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_16.pdf. Last accessed January, 2013. 16. Bhagani S, Sweny P, Brook G. Guidelines for kidney transplantation in patients with HIV disease. HIV Med 2006; 7(3):133-9. 17. Shah AP, Mangus RS, Powelson JA et al. Impact of recipient age on whole organ pancreas transplantation. Clin Transplant 2013; 27(1):E49-55. 18. Afaneh C, Rich BS, Aull MJ et al. Pancreas transplantation: does age increase morbidity? J Transplant 2011; 2011:596801. 19. Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in patients older than 50 years. Transplant Int 2011; 24(2):136-42. 20. Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be restricted because of age. Transplant Int 2011; 24(2):134-35. 21. Organ Procurement and Transplantation Network (OPTN). Policies and Bylaws: Allocation of Deceased Kidneys. Available online at: http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_7.pdf. Last accessed January, 2013. 22. Canadian Agency for Drugs and Technology in Health. Pancreas Transplantation to Restore Glucose Control: Review of Clinical and Economic Evidence. 2007. Available online at: http://cadth.ca/media/pdf/I3005_Pancreatic_Transplantation_tr_e.pdf. Last accessed January, 2014. 23. Centers for Medicare and Medicaid Services (CMS). Medicare approved pancreas and kidney/pancreas transplant centers. Available online at: http://www.cms.gov/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf. Last accessed January, 2014. 24. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for pancreas Transplants (260.3). Effective 4/26/2006. Available online at: http://www.cms.gov/medicare- coverage-database/overview-and-quick-search.aspx?clickon=search. Last accessed January, 2014.

6