Clinical Policy Title: Pancreas transplantation

Transcription

1 Clinical Policy Title: Pancreas transplantation Clinical Policy Number: Effective Date: April 1, 2016 Initial Review Date: October 21, 2015 Most Recent Review Date: February 6, 2018 Next Review Date: February 2019 Policy contains: Pancreas alone. Pancreas kidney. Islet cell. Diabetes. Related policies: CP# CP# Artificial pancreas device system Kidney transplantation ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of pancreas transplantation to be clinically proven and, therefore, medically necessary in members with type 1 diabetes mellitus when the following criteria are met (Hayes, 2015; Sung, 2015; Paty, 2013; Kidney Disease: Improving Global Outcomes Transplant Work Group [KDIGO], 2009): For simultaneous pancreas kidney transplantation using deceased donor pancreas and kidney or deceased donor pancreas and live donor kidney, members must meet all the criteria for kidney transplantation (see clinical policy Kidney transplantation). For pancreas transplantation after a previous kidney transplantation (pancreas-after-kidney) in members with stable kidney graft function (creatinine clearance > 40 ml/min). For pancreas transplantation alone using deceased donor whole organ in members who meet all of the following criteria: Diagnosis of type 1 diabetes mellitus and one of the following: Be beta cell autoantibody-positive. 1

2 Demonstrate insulinopenia, defined as a fasting C-peptide level of 110 percent 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 of 225 mg/dl. A history of severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and persistent labile diabetes despite optimal medical management. Optimally and intensively managed by an endocrinologist for at least 12 months with the most medically recognized advanced insulin formulations and delivery systems. Satisfactory kidney function (creatinine clearance > 40 ml/min). Adequate cardiac status (e.g., no angiographic evidence of significant coronary artery disease, ejection fraction 40 percent, no myocardial infarction in the last six months or negative stress test). Documentation of compliance with medical management. An acceptable psychosocial risk for transplantation surgery and the lifelong need for immunosuppression. Otherwise a suitable candidate for transplantation. AmeriHealth Caritas considers the use of pancreas transplantation in persons with type 2 diabetes mellitus to be clinically proven and, therefore, medically necessary when all of the following criteria are met (Hayes, 2015; Weems, 2014): Simultaneous pancreas kidney transplantation using deceased donor pancreas and kidney or deceased donor pancreas and live donor kidney is performed. Body mass index < 30 kg/m 2. Insulin dependence. Low total insulin requirements (< 1 U/kg of ideal body weight per day). Imminent or established renal failure (dialysis dependent or pre-dialysis advanced diabetic nephropathy with glomerular filtration rate [GFR] 20 ml/min/1.73 m 2 ). Fasting C-peptide < 10 ng/ml. Low cardiac and vascular disease risk. History of medical and dietary compliance. AmeriHealth Caritas considers the use of pancreas re-transplantation to be clinically proven and, therefore, medically necessary upon individual case review. AmeriHealth Caritas considers the use of autologous islet cell transplantation to be clinically proven and, therefore, medically necessary to prevent postsurgical diabetes in patients with medically refractory chronic pancreatitis who require total pancreatectomy (Hayes, 2016; American Diabetes Association [ADA], 2018). 2

3 AmeriHealth Caritas considers the following procedures to be investigational and, therefore, not medically necessary: Allogeneic islet cell transplantation (Speight, 2010). Autologous islet cell transplantation in persons with type 1 diabetes mellitus (Blue Cross Blue Shield Association, 2004). Limitations: Requests for pancreas transplantation in patients with the following conditions require secondary review: Chronic liver disease. Clinical evidence of severe cerebrovascular or peripheral vascular disease (e.g., ischemic ulcers, previous amputation secondary to vascular disease). Adequate peripheral arterial supply should be determined by standard evaluation in the vascular laboratory, including Doppler examination and plethysmographic readings of systolic blood pressure. Past psychosocial abnormality. Body mass index 30 kg/m 2 but < 35 kg/m 2. Structural genitourinary abnormality or recurrent urinary tract infection. Substance use history (other than persistent substance use). Treated malignancy (simultaneous pancreas kidney transplantation is considered medically necessary in persons with malignant neoplasm if the neoplasm has been adequately treated and the risk of recurrence is small). Uncontrolled hypertension. Absolute contraindications to pancreas transplantation include, but are not limited to: Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention definition of CD4 count, 200 cells/mm 3 ) unless all of the following criteria are met: CD4 count greater than 200 cells/mm 3 for more than six months. Human immunodeficiency virus type 1 RNA undetectable. On stable anti-retroviral therapy for more than three months. No other complications from AIDS (e.g., opportunistic infection, Kaposi's sarcoma or other neoplasm). Meeting all other criteria for pancreas or pancreas kidney transplantation. Active drug use and alcohol dependence. Active hepatitis or cirrhosis, or both. Active or recent malignancy. Active peptic ulcer. Body mass index 35 kg/m 2 (bariatric surgery should be considered). Demonstrated patient non-adherence to medical recommendations (e.g., failure to comply with prescribed drug regimens). 3

4 Ongoing or recurring infections that are not effectively treated. Potential complications from immunosuppressive medications unacceptable to the patient. Psychiatric disease that may compromise patient compliance. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate surgery. Serious conditions unlikely to be improved by transplantation as life expectancy can be finitely measured. Pancreas transplantation is not medically necessary for organs sold rather than donated to a recipient. Pancreas transplantation is not medically necessary for artificial organs or human organ transplantation service for which the cost is covered or funded by governmental, foundation or charitable grants. All other uses of pancreas transplantation are not medically necessary. For Medicare members only: AmeriHealth Caritas considers the use of pancreas transplantation to be clinically proven and, therefore, medically necessary in persons with type 1 diabetes mellitus when criteria for coverage in the following policies are met: National Coverage Determination (NCD) for Pancreas Transplants (260.3). Medicare Benefit Policy Manual Chapter 11 End Stage Renal Disease (ESRD). AmeriHealth Caritas considers the use of transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial) (see section of the NCD Manual) not to be medically necessary. Alternative covered services: Exogenous insulin therapy. Hemodialysis. Peritoneal dialysis. Background A pancreas transplantation is a means of providing an endogenous, self-regulated source to achieve physiologic insulin regulation without inducing adverse effects associated with administration of exogenous insulin (National Kidney Foundation, 2015). The goal of pancreas transplantation is to produce a lasting normoglycemic state that enhances quality of life. The procedure may involve the whole pancreas, a pancreas segment or a large group of pancreatic islet cells. The primary cause of pancreatic disease is type 1 diabetes mellitus, followed by type 2 diabetes mellitus, chronic pancreatitis, cancer and cystic fibrosis (Kandaswamy, 2015). Whole organ transplantation from 4

5 deceased donors is the most common pancreas transplantation procedure, but segmental transplantation may be done if a living donor is involved (National Pancreas Foundation, 2015). The majority of procedures are simultaneous pancreas kidney transplantation, because many people with pancreas failure also have renal failure. Pancreas transplantation may also include transplantation of the duodenum in some patients with digestive disorders (Kandaswamy, 2015; Organ Procurement and Transplantation Network [OPTN], 2015). Islet cell transplantation may be a potential alternative in which the insulin-producing beta cells have been destroyed. Clusters of islet cells are usually transplanted directly into the liver where they begin to produce insulin and may be able to replace the function of the pancreas. Regulatory status: The Health Resources Services Administration within the Department of Health and Human Services has oversight responsibility for the organ allocation system in the United States through the OPTN. The United Network for Organ Sharing (UNOS) administers the OPTN to which transplantation centers are required to report (OPTN, 2015a). The U.S. Food and Drug Administration (FDA) does not regulate the transplantation of human organs containing blood vessels, such as kidney, liver, heart, lung or pancreas. However, the FDA does regulate allogeneic islet cell transplantation as somatic cell therapy. Clinical studies to determine safety and effectiveness outcomes of allogeneic islet cell transplantation must be conducted under an FDA investigational new drug regulation (FDA, 2009). Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Center for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on December 27, Search terms were pancreas transplantation (MeSH) and islets of Langerhans transplantation (MeSH). We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 5

6 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings We identified four systematic reviews (Hayes, 2015; Bramis, 2012; Speight, 2010, Blue Cross Blue Shield Association, 2004), one survival analysis (Sung, 2015), one economic analysis (Wilson, 2015) and three evidence-based guidelines (Paty, 2013; KDIGO, 2009; Robertson, 2006) for this policy. Whole organ pancreas transplantation is an acceptable alternative to exogenous insulin in carefully selected patients with type 1 diabetes mellitus. The majority of the evidence assessed pancreas transplantation in persons with difficult-to-control type 1 diabetes mellitus in whom a kidney transplantation had been performed or was imminent. Transplantation techniques were pancreas transplantation alone, simultaneous pancreas kidney transplantation, pancreas-after-kidney and allogeneic islet cell. Evidence from a limited number of living-related donor segmental pancreas transplantation suggests these grafts have a lower rejection rate and may provide a more satisfactory long-term outcome than whole pancreas grafts from deceased donors. Pancreas transplantation is associated with significant perioperative risks, including graft thrombosis, hemorrhage, pancreatitis, wound infection, peripancreatic abscesses and duodenal stump leakage. As with other solid organ transplantations, contraindications include the presence of active or recent malignancy; chronic active hepatitis or cirrhosis, or both; morbid obesity; psychiatric disease; recent history of noncompliance; active alcoholism or drug dependency, or both; inability to withstand surgery and immunosuppression; active sepsis; cardiovascular disease or active peptic ulcer. Increasing age has been a part of the exclusion criteria used when determining eligibility. While an upper age limit has not been established in the literature, a UNOS database review of all adult pancreas alone and simultaneous pancreas kidney transplantations between 1996 and 2012 found decreased patient and graft survival in patients of increasing age compared with patients younger than age 50 (Siskind, 2014). There is sufficient evidence to support pancreas transplantation alone (deceased or living-donor segmental) in patients with type 1 diabetes mellitus and preserved renal function to correct severe metabolic complications. It has been performed mostly in patients with hypoglycemic unawareness or labile diabetes (including patients with frequent episodes of ketoacidosis) who have failed insulin-based management and may have incapacitating clinical or emotional problems with exogenous insulin therapy. Procedural success can eliminate the acute complications commonly experienced by individuals with type 1 diabetes mellitus, stabilize neuropathy and improve quality of life primarily by eliminating the need for exogenous insulin, frequent daily blood glucose measurements and many of the dietary restrictions imposed by the disorder. Patient survival rates of pancreas transplantation alone and pancreas kidney transplantations are similar, and graft survival rates of pancreas transplantation alone and pancreas-after-kidney are similar. 6

7 Two OPTN/UNOS database analyses underscore the importance of monitoring kidney function before and after pancreas transplantation alone., Kidney failure developed in approximately 10 percent of patients at five years follow-up, and kidney transplantations were required (Nata, 2013). Kidney function before pancreas transplantation alone is a strong, independent predictor of end-stage renal disease (Kim, 2014). End-stage renal disease was 7.74 (95 percent confidence interval [CI] 4.37 to 13.74) and 3.25 (95 percent CI 1.77 to 5.97) times more likely to develop in patients with an estimated GFR of < 60 ml/min/1.73 m 2 and 60 to 89.9 ml/min/1.73 m 2, respectively, than in those with an estimated GFR of 90 ml/min/1.73 m 2. The ideal management of candidates for pancreas transplantation alone with an estimated GFR of < 60 ml/min/1.73 m 2 remains to be determined. These results may inform patient selection and the use of targeted interventions to reduce the risk of progressive kidney impairment in this patient population. There is sufficient evidence to support the use of pancreas kidney transplantation either simultaneously or sequentially in patients with uremia and type 1 diabetes mellitus who have been carefully selected. Successful transplantation does not jeopardize patient survival, may improve kidney survival, will restore normoglycemia and improves quality of life. As a single procedure, simultaneous pancreas kidney transplantation offers the potential benefits of shorter waiting time, an expanded organ donor pool and improved short-term and long-term renal graft function. For those who have a living kidney donor, pancreas-after-kidney is preferable to waiting years for a cadaver donor for a simultaneous procedure. There is insufficient evidence to support the use of islet cell transplantation for treating type 1 diabetes mellitus. It holds significant potential advantages over whole-gland transplantation and for patients with benign prostatic disease (e.g., chronic pancreatitis), but its long-term survival has yet to be achieved. At this time, it is a rapidly evolving technology that also requires systemic immunosuppression and should be performed only within the setting of controlled research studies. Since 1995, the rate of pancreas transplantation among individuals with type 2 diabetes mellitus has increased significantly (Gruessner, 2011). Yet, there remains an absence of unified and defined criteria for candidacy. Results from a small number of case series suggest five-year patient and graft survival after simultaneous pancreas kidney transplantation is comparable between patients with type 1 diabetes mellitus and those with type 2 diabetes mellitus, but long-term outcomes are lacking (Hayes, 2015). Simultaneous pancreas-kidney transplantation candidates with type 2 diabetes mellitus tend to be younger with a relatively lean body habitus and limited advanced diabetic cardiovascular disease. For potential candidates with type 2 diabetes mellitus, Weems (2014) proposed the following selection criteria for simultaneous pancreas kidney transplantation: Younger than age 55 years. Body mass index of < 30 kg/m 2. Insulin dependence. Low total insulin requirements (< 1 U/kg of ideal body weight per day). 7

8 Presence of renal failure (dialysis-dependent or pre-dialysis advanced diabetic nephropathy with GFR 20 ml/min/1.73 m 2 ). Fasting C-peptide < 10 ng/ml. Low cardiac and vascular disease risk. History of medical and dietary compliance. Growing evidence suggests chronologic age alone should not exclude a patient for candidacy. One large case series found that while complications may occur, older recipients (age 55 and older) of pancreas transplantation had comparable long-term patient and graft survival rates to those of younger recipients; additionally, type of organ transplantation did not correlate with patient survival in older patients (Scalea, 2016). Patient selection should be based on clinical criteria other than absolute age. Policy updates: In 2018, we added a new systematic review (Hayes, 2016) and evidence-based guideline (ADA, 2018) supporting autologous islet cell transplantation for patients requiring total pancreatectomy for medically refractory chronic pancreatitis to prevent postsurgical complete insulin and glucagon deficiency (ADA, 2018). This indication was added to the policy. Summary of clinical evidence: Citation Hayes (2015, last updated 2016) Total pancreatectomy with islet autotransplantation (TP/IAT) for chronic pancreatitis Hayes (2013, updated 2015) Simultaneous pancreas kidney transplantation Content, Methods, Recommendations Key points: Systematic review of nine noncomparative studies and seven nonrandomized comparative studies using pancreas allotransplantation and prior pancreatic surgery as comparators. Overall quality: low. TP/IAT appears safe with low procedure-associated complications and mortality, and may be associated with durable improvements in pain incidence and severity, reductions in narcotics use for pain relief and improvements in health-related quality of life, patientreported health and activities of daily living, while maintaining glycemic control and insulin independence in many cases. Its effect on survival is undetermined. TP/IAT may be the only viable option for patients with chronic pancreatitis with debilitating symptoms who have exhausted all available standard therapies. TP/IAT is performed at a few specialized centers; its efficacy and safety in other clinical settings is unknown. There is a lack of standardized patient selection guidelines for TP/IAT. Key points: Systematic review of 21 retrospective nonrandomized analyses and three prospective cohort studies, including large-scale registry analyses (2000-March, 2015), with a sample size range of 101 to 15,282 patients. Overall quality: moderate. Patient characteristics: mostly type 1 diabetes mellitus, mean age, 35 to 45 years. Criteria: established end-stage renal disease (e.g., creatinine clearance < 30 ml/minute), and confirmed diabetic nephropathy in patients taking insulin. 8

9 Citation Wilson (2015) Cost-effectiveness analysis of medical versus surgical management of minimal change chronic pancreatitis (MCCP) Sung (2015) Simultaneous pancreas kidney transplantation versus kidney transplantation alone in type 1 diabetes mellitus Bramis (2012) TP/IAT for chronic pancreatitis Speight (2010) Content, Methods, Recommendations Compared with kidney transplantation alone or wait listing, simultaneous pancreas kidney transplantation increased patient survival and kidney graft survival rates in patients with type 1 diabetes mellitus with imminent or established end-stage renal disease for many years after transplantation. Insufficient evidence for simultaneous pancreas-kidney transplantation among patients with type 2 diabetes mellitus; low-quality evidence suggests results are comparable for patients with type 1 and type 2 diabetes mellitus. Insufficient evidence comparing simultaneous pancreas kidney transplantation with pancreas transplantation alone or pancreas-after-kidney transplantation. Low-quality evidence suggests simultaneous pancreas kidney transplantation may not offer benefits over kidney transplantation alone from a living kidney donor. Key points: Key points: Detailed perioperative outcomes from 46 patients with MCCP populated a Markov model comparing medical management with TP/IAT. Mortality, complications, readmission rates, insulin and narcotic use, imaging and endoscopy were included. Cost and survival for TP/IAT versus medical management were $153,575 per 14.9 qualityadjusted life-years (QALYs) and $196,042 per 11.5 QALYs, respectively. Analysis of average treatment-specific survival curves, adjusting for differences in case mix. At 10 years, kidney graft survival time was greater by 0.18 years (P = 0.045) for simultaneous pancreas kidney versus kidney transplantation alone mainly in younger recipients of simultaneous pancreas kidney transplantation. Patient survival was 0.17 years greater (P = 0.033) for simultaneous pancreas kidney versus kidney transplantation alone. Simultaneous procedure is associated with modest survival benefit over kidney transplantation alone, but overall survival is equivalent at about two years. Key points: Systematic review of five cohort studies published through TP/IAT significantly reduced pain and opiate requirements after procedure based on two studies. Concurrent TP/IAT reduced insulin requirement; the rate of insulin independence ranged from 46 percent of patients at five years' mean follow-up to 10 percent at eight years. The impact on quality of life was poorly reported. Insufficient evidence of optimal timing of TP/IAT in relation to the evolution of chronic pancreatitis. Key points: Islet cell or pancreas transplantation for type 1 diabetes mellitus Systematic review of 12 studies assessing patient-reported outcomes (PRO) of pancreasafter-kidney, pancreas transplantation alone, islet-after kidney (IAK), and islet transplantation alone. Sample sizes ranged from seven to 205 patients, included nine specified and two unspecified PRO measures. 9

10 Citation Content, Methods, Recommendations Overall quality: poor. Small sample sizes; some PRO measures may lack sensitivity to detect actual changes after transplantation. Insufficient evidence of full impact of islet cell or pancreas transplantation (alone or after kidney) on quality of life. Some PRO measures excluded issues and domains of life likely to be important post-transplantation and when patients may no longer perceive themselves to have diabetes. Satisfaction not assessed. References Professional society guidelines/other: Kidney Disease: Improving Global Outcomes Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2009; 9 Suppl 3: S DOI: /j.jcjd Paty BW, Koh A, Senior P. Pancreas and islet transplantation. Canadian journal of diabetes. 2013; 37 Suppl 1: S DOI: /j.jcjd Robertson RP, Davis C, Larsen J, Stratta R, Sutherland DE. Pancreas and islet transplantation in type 1 diabetes. Diabetes care. 2006; 29(4): 935. Available at: Accessed December 27, Peer-reviewed references: Basics About Diabetes. CDC website. Accessed December 27, Bramis K, Gordon-Weeks AN, Friend PJ, et al. Systematic review of total pancreatectomy and islet autotransplantation for chronic pancreatitis. Br J Surg. 2012; 99(6): DOI: /bjs Common Disorders of the Pancreas. National Pancreas Foundation website. Accessed December 27, Gruessner AC 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 (IPTR). Rev Diabet Stud. 2011; 8(1): DOI: /rds Guidance for Industry. Considerations for Allogeneic Pancreatic Islet Cell Products. September, FDA website. 10

11 dances/cellularandgenetherapy/ucm pdf. Accessed December 27, Hayes Inc., Hayes Medical Technology Report. Simultaneous Pancreas-Kidney (SPK) Transplantation in Diabetic Patients. Lansdale, Pa: Hayes, Inc.; March 27, Hayes Inc., Hayes Medical Technology Report. Total Pancreatectomy with Islet Autotransplantation for Chronic Pancreatitis. Lansdale, Pa. Hayes Inc.; December 22, Updated December 16, Islet transplantation in patients with type 1 diabetes mellitus. Evidence Report/Technology Assessment No. 98 (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidencebased Practice Center under Contract No ). AHRQ Publication 04-E Rockville, MD: Agency for Healthcare Research and Quality. August Kandaswamy R, Skeans MA, Gustafson SK, et al. OPTN/SRTR 2013 Annual Data Report: pancreas. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2015; 15 Suppl 2: DOI: /ajt Kidney-Pancreas Transplant. National Kidney Foundation (NKF) website. Accessed December 27, Kim SJ, Smail N, Paraskevas S, et al. Kidney function before pancreas transplant alone predicts subsequent risk of end-stage renal disease. Transplantation. 2014; 97(6): DOI: /01.TP Nata N, Huang E, Kamgar M, et al. Kidney failure requiring kidney transplantation after pancreas transplant alone. Clin Transpl. 2013: Organ Procurement and Transplantation Network (OPTN). About the OPTN. U.S. Department of Health & Human Services website. Accessed December 27, Scalea JR, Redfield RR, 3rd, Arpali E, et al. Pancreas transplantation in older patients is safe, but patient selection is paramount. Transpl Int. 2016; 29(7): DOI: /tri Siskind E, Maloney C, Akerman M, et al. An analysis of pancreas transplantation outcomes based on age groupings--an update of the UNOS database. Clinical transplantation. 2014; 28(9): DOI: /ctr Speight J, Reaney MD, Woodcock AJ, Smith RM, Shaw JA. Patient-reported outcomes following islet cell or pancreas transplantation (alone or after kidney) in Type 1 diabetes: a systematic review. Diabetic 11

12 medicine : a journal of the British Diabetic Association. 2010; 27(7): DOI: /j x. Sung RS, Zhang M, Schaubel DE, et al. A Reassessment of the Survival Advantage of Simultaneous Kidney-Pancreas Versus Kidney-Alone Transplantation. Transplantation. 2015; 99(9): DOI: /tp Weems P, Cooper M. Pancreas transplantation in type II diabetes mellitus. World Journal of Transplantation. 2014; 4(4): DOI: /wjt.v4.i Wilson GC, Ahmad SA, Schauer DP, Eckman MH, Abbott DE. Cost-effectiveness of total pancreatectomy and islet cell autotransplantation for the treatment of minimal change chronic pancreatitis. Journal of gastrointestinal surgery: official journal of the Society for Surgery of the Alimentary Tract. 2015; 19(1): 46 54; discussion DOI: /s CMS National Coverage Determination (NCDs): Pancreas Transplants. CMS website. Accessed December 27, Medicare Benefit Policy Manual Chapter 11 - End Stage Renal Disease (ESRD). CMS website. Accessed December 27, A52474 Immunosuppressive Drugs - Policy Article. CMS website. Accessed December 27, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells Transplantation of pancreatic allograft 12

13 ICD-10 Code Description Comment E10.1-E10.9 E11.0-E11.9 T T Type 1 diabetes mellitus Type II diabetes mellitus Complications of other transplanted tissue HCPCS Level II Code G0341 G0342 G0343 S2065 S2102 S2152 Description Percutaneous islet cell transplant, includes portal vein catheterization and infusion Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion Laparotomy for islet cell transplant, includes portal vein catheterization and infusion Simultaneous pancreas kidney transplantation Islet cell tissue transplant from pancreas; allogeneic Solid organ(s), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications; including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services, and the number of days of pre- and post-transplant care in the global definition Comment 13