Sunflower Health Plan Pancreas Transplantation (PDF) Form

This policy describes the medical necessity requirements for pancreas transplantation procedures. Multiple types of pancreas transplants are effective therapeutic options for arresting the progression of complications of diabetes mellitus and improving the quality of life for diabetic patients, including simultaneous pancreas kidney transplant (SPK), pancreas after kidney transplant (PAK), pancreas transplant alone (PTA), and islet cell transplant.1 Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that pancreas transplantation is medically necessary when meeting all of the following: A. Member/enrollee has one of the following: 1. Diagnosis of diabetes mellitus requiring insulin (members/enrollees with requirements for insulin over one unit/kg should be closely evaluated as they may be less likely to benefit from pancreas transplant compared to those with lower insulin doses); 2. Diagnosis of exocrine pancreatic insufficiency; 3. A requirement for the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons; B. Does not have ANY of the following contraindications:2,8 1. Malignancy with high risk of recurrence or death related to cancer; 2. Glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi- organ transplant; 3. Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 days; 4. Acute liver failure, or cirrhosis with portal hypertension or synthetic dysfunction unless being considered for multi-organ transplant; 5. Septic shock; 6. Active infection with highly virulent and/or resistant microbes that are poorly controlled pre-transplant; 7. Active tuberculosis infection; 8. HIV infection with detectable viral load; 9. Progressive cognitive impairment; 10. Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support; 11. Active substance use or dependence including current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), or IV drug use without convincing evidence of risk reduction behaviors (unless urgent transplant timelines are present, in which case a commitment to reducing behaviors is acceptable). Serial blood and urine testing may be used to verify abstinence from substances that are of concern; 12. Chronic, non-healing wounds; Page 1 of 9 CLINICAL POLICY Pancreas Transplantation 13. Significant comorbidities, such as advanced cardiopulmonary, cardiovascular, cerebrovascular, or peripheral vascular disease; 14. Other severe uncontrolled medical condition expected to limit survival after transplant; C. Request is for one of the following procedures and meets the corresponding criteria: 1. Pancreas Transplant Alone (PTA), meets all: a. Recurrent, severe, and potentially life-threatening metabolic complications that require medical attention, as documented by chart notes, emergency room visits, or hospitalizations, including any of the following: i. Severe hypoglycemia unawareness; ii. Marked hyperglycemia; iii. Recurring severe ketoacidosis; b. Clinical or clinical and emotional problems with exogenous insulin therapy that are so severe as to be incapacitating or consistent failure of insulin-based management to prevent acute complications; c. Has been medically managed by an endocrinologist for at least 12 months; 2. Simultaneous Pancreas Kidney Transplant (SPK), meets all: a. Meets above criteria for PTA; b. End-stage renal disease (ESRD), as defined by both: i. Presence of uremia; ii. Requires dialysis or is expected to require dialysis in the next 12 months; c. Glomerular filtration rate (GFR) < 20mL/min (does not have to be the most recent value) or creatinine clearance (CrCl) < 20mL/min; 3. Pancreas After Kidney Transplant (PAK), meets all: a. Meets above criteria for PTA; b. Underwent successful kidney transplant without significant chronic rejection of kidney transplant; c. Stable kidney transplant function, as defined by both: i. Stable creatinine clearance ≥ 30 mL/min; ii. Absence of significant proteinuria. II. It is the policy of health plans affiliated with Centene Corporation that autologous islet cell transplants are considered medically necessary as an adjunct procedure to a total or near total pancreatectomy for severe, refractory pancreatitis. III.It is the policy of health plans affiliated with Centene Corporation that pancreas re- transplantations are considered medically necessary after one failed primary pancreas transplant. IV. It is the policy of health plans affiliated with Centene Corporation that current evidence does not support the use of pancreas transplant procedures for any of the following indications: A. Re-transplantations after two or more failed primary pancreas transplantations; B. Allogeneic islet cell transplantation or xenotransplantation; C. SPK transplantation for patients with amputation due to peripheral obstructive vascular disease; D. For the treatment of all other conditions than those specified above. Page 2 of 9 CLINICAL POLICY Pancreas Transplantation Background The American Diabetes Association defines diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia that results from defects in insulin secretion, insulin action, or both.3 According to the Centers for Disease Control and Prevention estimations, approximately 37.3 million people or 11.3% of the United States population has diabetes with approximately 8.5 million undiagnosed cases.4 Chronic hyperglycemia existing in diabetic patients facilitates long term organ damage, especially to the eyes, kidneys, nerves, and blood vessels.3 The prevalent type 2 diabetes is caused by a resistance to insulin action and an inadequate compensatory insulin secretory response.3 Type 1 diabetes is caused by immune mediated destruction of the insulin secreting pancreatic β cells.5 Islet cell autoantibodies, insulin autoantibodies, autoantibodies to glutamic acid decarboxylase, zinc transporter 8 (ZnT8A), and autoantibodies to the tyrosine phosphatase IA-2 and IA-2β are serological markers of the pancreatic β cell destruction observed in type 1 diabetes.3,5,6 Pancreas transplantation allows for the possibility to restore glucose regulated endogenous secretion, decrease the progression of diabetic complications, and improve quality of life in patients with diabetes.1,7 Pancreas transplantation is the only proven method to restore normoglycemia in type 1 diabetic patients.8 Simultaneous pancreas kidney transplant (SPK), pancreas after kidney transplant (PAK), and pancreas transplant alone (PTA) are primarily performed on patients with type 1 diabetes.8 SPK is an established procedure for diabetic patients with advanced chronic kidney disease or end stage kidney disease and accounts for approximately 90% of pancreas transplants performed in the United States.9 A 2011 study by Gruessner10 reviewed the outcomes of SPK, PAK, and PTA transplantations according to follow-up data collected by the International Pancreas Transplant Registry. Patient survival rates were reported to be over 95% after one year and over 83% at five years post-transplant. The highest graft survival rates were observed in SPK transplants at 86% for pancreas and 93% for kidney graft function one year post-transplant. PAK procedures displayed graft function at 80%, while PTA had graft function at 78% one year after transplantation.10 Graft survival rate is defined as total freedom from insulin therapy, normal fasting blood glucose concentrations, and normal or only slightly elevated hemoglobin A1C values.11 The study demonstrated that pancreas transplantation offers excellent outcomes for patients with labile diabetes due to the improvement in patient survival and graft function shown in all three categories over the course of 24 years.10 Patients undergoing pancreas transplantation, especially SPK transplant, require extensive immunosuppression regiments.1 It is theorized that pancreas transplant recipients require higher levels of immunosuppression therapy than other solid organ transplants due to the immunogenicity of the pancreas or the autoimmune status of the recipient.12 During pancreatic islet autotransplantation, Islet β cells are transferred into the liver through the portal vein of the recipient.1 Pancreatic islet autotransplantation is performed following a pancreatectomy in patients with severe chronic pancreatitis. Chronic pancreatitis is a debilitating disease which causes diarrhea, weight loss, poor quality of life, and severe abdominal pain that is difficult to alleviate with pharmacological treatment or other therapeutic measures.1,13 Due to the Page 3 of 9 CLINICAL POLICY Pancreas Transplantation excessive pain observed in patients with chronic pancreatitis, pain control is a primary goal of pancreatectomy and pancreatic islet autotransplantation.13 Coding Implications This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2020, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT Codes that support coverage criteria CPT®* Codes 48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas of pancreatic islet cells Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding soft tissues, splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels, and Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to splenic artery Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastomosis, each Transplantation of pancreatic allograft Removal of transplanted pancreatic allograft Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral Donor nephrectomy (including cold preservation); open, from living donor Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each Recipient nephrectomy (separate procedure) Renal allotransplantation, implantation of graft; without recipient nephrectomy Renal allotransplantation, implantation of graft; with recipient nephrectomy 48550 48551 48552 48554 48556 50300 50320 50323 50325 50327 50340 50360 50365 CPT Codes that do not support coverage criteria Page 4 of 9 CLINICAL POLICY Pancreas Transplantation CPT® Codes 0584T 0585T 0586T HCPCS Codes S2065 Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; percutaneous Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; laparoscopic Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; open Simultaneous pancreas kidney transplantation Reviews, Revisions, and Approvals Policy developed. Reviewed by specialist 4/16. References reviewed and updated Removed “islet cell transplantation” from III. References reviewed and updated. ICD-10 and HCPCS codes added. Minor wording changes to description for clarity Added “early prostate cancer with a low Gleason score,” as an exception to malignancy contraindication, I.b. Removed “and/or islet cell” from IV. A. References reviewed and updated. Specialist reviewed. References reviewed and updated. In I.D.2.b for SPK, changed GFR “<20” to GFR “≤ 20”. Added 2020 CPT codes that do not support coverage criteria (0584T, 0585T, 0586T) Added ICD-10 Z94.83 Edited malignancy contraindication to not specify within 2 years, or low Gleason score, and added exceptions early stage prostate cancer, cancer that has been completely resected, or that has been treated and poses acceptable future risk. Clarified that BMI maximal allowable value in I.B. 2 is (i.e., < 30 to 35 kg/m2, depending on transplant center). Background updated to reflect current data. References reviewed and updated. Replaced “member” with “member/enrollee” in all instances. Under contraindication I.C. removed “malignancy metastasized to or extending beyond the margins of the kidney and/or pancreas” as this is inclusive to contraindication #1. Removed contraindication of “severely limited functional status with poor rehabilitation potential.” Replaced “Psychiatric or psychological condition associated with the inability to cooperate or comply with medical therapy” and the contraindication regarding non-compliance with medical therapy with “Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.” Changed Revision Date 02/16 03/17 01/18 Approval Date 04/16 03/17 02/18 05/18 01/19 02/19 01/20 02/20 05/20 05/20 01/21 02/21 08/21 08/21 Page 5 of 9 Revision Date Approval Date 02/22 02/22 02/23 02/23 CLINICAL POLICY Pancreas Transplantation Reviews, Revisions, and Approvals “Review Date” in header to “Date of Last Revision,” and “Date” in the revision log header to “Revision Date.” Annual review. References reviewed and updated. Updated description and background with no clinical significance. Removed requirement in I.A. that medical therapy does not exist or has failed. Updated all contraindications in criteria I.C. “Experimental/investigational” verbiage replaced in criteria IV. statement with descriptive language. Specialist reviewed. Annual review. Removed criterion I.A. stating that medical treatment does not exist or has failed. Removed C-peptide values and BMI requirements from Criteria I.B.1 and I.B.2. Noted in I.B.1. that member/enrollees with requirements for insulin over one unit/kg should be closely evaluated as they may be less likely to benefit from pancreas transplant compared to those with lower insulin doses Added indication in I.B.2 for exocrine pancreatic insufficiency. Added indication I.B.3. for requirement for the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons; Changed “chronic” to “active” in infection contraindication in I.C.7. Removed acute renal failure contraindication. Criteria I.C.12. updated to exclude marijuana use when prescribed by a licensed practitioner and include required commitment to reducing substance use behaviors if urgent transplant timelines are present. Added chronic, non-healing wounds as contraindication in Criteria I.C.13. Added contraindication of significant comorbidities in Criteria I.C.14. Clarified in I.C.1.b that problems with insulin could be clinical or clinical and emotional. Added in I.C.2.c. that the GFR does not have to be the most recent value. Added Criteria I.D.1.c. requirement for being medically managed by an endocrinologist for at least 12 months for pancreas transplant alone. Added requirements for SPK and PAK that PTA criteria also needs to be met for those procedures. ICD-10 codes removed. Background updated with no impact on criteria. References reviewed and updated.