Medical Policy

 

Subject: Pancreas Transplantation and Pancreas Kidney Transplantation
Document #: TRANS.00011 Publish Date:    04/25/2018
Status: Reviewed Last Review Date:    03/22/2018

Description/Scope

This document addresses pancreas alone or a pancreas/kidney transplant which involves the removal of human organs from a deceased or living donor with the implantation into a single recipient.

Position Statement

Note: Members must meet the disease specific criteria as well as the General Individual Selection criteria below for the transplantation to be considered medically necessary.

Medically Necessary:

Simultaneous deceased-donor pancreas/kidney transplant (SPK) is considered medically necessary for individuals with insulin dependent diabetes mellitus (IDDM) who have end-stage renal disease.

Simultaneous deceased-donor pancreas and living-donor kidney transplant (SPLK) is considered medically necessary for individuals with insulin dependent diabetes mellitus who have end-stage renal disease.

Pancreas transplant alone (PTA) either deceased or living-donor segmental is considered medically necessary for individuals who have insulin dependent diabetes mellitus with severe disabling and documented life threatening hypoglycemic unawareness due to labile diabetes which persists despite optimal medical management.

Pancreas after kidney transplant (PAK) is considered medically necessary for individuals with insulin dependent diabetes mellitus.

One pancreas alone, one pancreas after kidney or one simultaneous pancreas/kidney (SPK or SPLK) re-transplantation after failure of the primary graft is considered medically necessary provided the individual meets the transplant criteria above.

Investigational and Not Medically Necessary:

Pancreas transplantation is considered investigational and not medically necessary for all other applications.

A third or subsequent pancreas alone, pancreas after kidney or SPK or SPLK transplantation is considered investigational and not medically necessary in all cases.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

General Individual Selection Criteria

In addition to having the clinical indications above, the member must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications- for Transplant Recipients include, but are not limited to, the following:

  1. Metastatic cancer
  2. Ongoing or recurring infections that are not effectively treated
  3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery
  4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured
  5. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations
  6. Potential complications from immunosuppressive medications are unacceptable to the patient
  7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/mm3) unless the following are noted:
    1. CD4 count greater than 200 cells/mm3 for greater than 6 months
    2. HIV-1 RNA undetectable
    3. On stable anti-retroviral therapy greater than 3 months
    4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm)
    5. Meeting all other criteria for pancreas or pancreas/kidney transplantation.

Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.

Rationale

Simultaneous Pancreas-Kidney Transplantation (SPK)
The level of evidence consists primarily of case series or summaries of institutional experience with SPK and pancreas after kidney (PAK) transplants, transplant registry reports, evaluations of secondary complications of diabetes and their relationship to SPK/PAK, and measures of Quality of Life (QOL) associated with these procedures. Collectively, this evidence has established that SPK is effective in normalizing insulin production and kidney function, may improve quality of life, and halts, slows or reverses the progression of secondary diabetic complications.

Simultaneous Cadaver-Donor Pancreas and Living-Donor Kidney Transplant (SPLK)
The evidence from the peer-reviewed literature supports the efficacy and use of a well-matched living-donor kidney. Such transplants offer the potential benefits of shorter waiting time, expansion of the organ donor pool, and improved short-term and long-term renal graft function. SPLK has the advantage of being a single procedure in contrast to the standard living-donor kidney transplant followed by PAK; in addition, SPLK in general leads to better early and long-term renal graft function.

Pancreas Transplant Alone (PTA)
Successful pancreas transplantation has been demonstrated in multiple case series studies to be efficacious in significantly improving the quality of life of people with type 1 diabetes, primarily by eliminating the need for exogenous insulin, frequent daily blood glucose measurements, and many of the dietary restrictions imposed by the disorder. Transplantation can also eliminate the acute complications commonly experienced by individuals with type 1 diabetes (e.g., hypoglycemia and hyperglycemia).

Pancreas After Kidney Transplant (PAK)
There is a paucity of data from controlled studies comparing pancreas after kidney and kidney transplant alone. Studies comparing the two procedures are case series or summaries of transplant centers' experience, rather than randomized studies, and, for the most part, involve small study samples, retrospective design, and relatively short follow-up considering the rate of late graft failure. Data from the International Pancreas Transplant Registry provides sufficient evidence to support the efficacy of PAK in carefully selected diabetics who have previously received a successful kidney transplant. The 1-year graft survival rate (defined as total freedom from insulin therapy, normal fasting blood glucose concentrations, and normal or only slightly elevated HbA1c) is 77.5%.

Living-Donor Segmental Pancreas Transplantation
Evidence from small case series studies focusing on the limited number of living-related donor segmental pancreas transplants indicates that these grafts have a lower rejection rate and may provide a more satisfactory long-term outcome than grafts from deceased donors.

National Transplant Data
According to the Organ Procurement Transplant Network (OPTN), in 2017 there were 213 PTA transplants and 789 SPK transplants performed in the US. As of February 13, 2018, 909 individuals are currently listed to receive a PTA and 1737 are awaiting an SPK transplant.

Survival data are available from the OPTN through February 9, 2018. After PTA, 5-year graft survival was 60.0% and 5-year patient survival was 79.4%.  After SPK, 5-year graft survival was 81.4% and 5-year patient survival was 88.7%.  

Pancreas Retransplantation
The effects of pancreas retransplantation on health outcomes (recipient survival, graft survival, morbidity) are reported from uncontrolled analyses in the literature.  According to data from the OPTN through February 9, 2018, 150 individuals were alive 1 year after a repeat PTA.  The 1-year survival rate after PTA was 96.2% and the 5-year survival rate was 82.2%.  There were 33 individuals alive after SPK retransplants, with a 1-year survival rate of 100% and a 5-year survival rate of 71.0%.

Background/Overview

PTA is a standard treatment option for individuals with IDDM who have failed insulin-based management leading to frequent and acute metabolic complications. SPK is a standard treatment option for individuals with IDDM with end-stage renal disease.

The annual incidence of type 1 diabetes has been rising worldwide. It is estimated that the prevalence of type 1 diabetes in the United States is approximately 1 in 300 by age 18.  Over one-third of individuals with IDDM eventually develop end-stage renal disease (ESRD), the treatment for which is either dialysis with glucose control or kidney transplantation. Dialysis is not considered a favorable long-term option due to low 5-year survival rates of approximately 33%.  Renal transplantation has demonstrated superiority over renal dialysis, with 5-year survival rates approximately 83% for individuals receiving cadaveric grafts and 92% for recipients of living-related transplants. However, adequate glycemic control is necessary to prevent recurrence of disease in the transplanted kidney. Although stringent glucose control for diabetics is possible, it can be difficult to achieve for many individuals, since it requires multiple injections of insulin every day combined with frequent self-monitoring of blood glucose levels. In addition, individuals on intensive insulin therapy have an elevated risk of severe hypoglycemia. Thus, pancreas transplantation has been investigated as a method of restoring glucose homeostasis in individuals with IDDM. For individuals who are candidates for a kidney transplant, a simultaneous pancreas transplant can restore glucose homeostasis and can provide the additional benefits that accompany being insulin-independent for many years.

For type 1 diabetics experiencing glucose control problems or progressive diabetic complications, pancreas transplantation may be performed alone (PTA), simultaneously with a kidney transplant (SPK), or after a successful kidney transplant (PAK). PTA is performed in nonuremic or preuremic individuals; SPK is performed in uremic individuals; and PAK is performed in individuals who have undergone successful kidney transplantation to correct previous uremia. Since kidney failure is one of the major diabetic complications, most potential pancreas graft recipients are uremic. PAK is generally reserved for individuals with a suitable replacement kidney from a living related donor, which is associated with increased kidney graft survival, as compared with a cadaver kidney. However, PAK is an infrequently performed procedure. Thus, most pancreas transplantation procedures involve SPK grafting; consequently, relatively few studies are available that detail the outcome of PAK. Additionally, only a few controlled clinical trials have investigated the risk and benefits of pancreas transplant alone as compared with intensive conventional therapy. One recent nonrandomized controlled study suggests that the relative increase in post-surgical mortality may not be balanced by an improvement in survival over the next 4 years. Study limitations identified include retrospective design and the fact that the transplants were performed at multiple transplant centers with varying experience, technique and immunosuppressive approaches, any of which can influence postoperative mortality. However, further studies are underway to investigate whether the benefits of surgery outweigh the risks in this population.

Pancreas transplantation involves the surgical removal of a segmental pancreas from a living donor or a whole pancreas from a deceased donor, and the implantation of the pancreas into a recipient. Pancreas transplantation has been used in an attempt to restore endogenous insulin secretion and normal glucose metabolism for individuals with insulin-dependent diabetes. It should be noted that pancreas transplantation is also associated with a significant incidence of adverse effects, including episodes of graft rejection, pancreatitis, dehydration and infectious, vascular and urologic complications. The use of immunosuppressive agents also increases the risk for developing infections, lymphomas and other malignancies. Based upon information obtained from the International Pancreas Transplant Registry (IPTR), the 1-year mortality rate is 6%.

Definitions

End Stage Renal Disease (ESRD): Persistent decline in renal function as documented by falling creatinine clearance in an individual diagnosed with a renal disease whose natural history is progression to renal impairment requiring renal replacement (dialysis or transplant).

Kidney: One of a pair of organs situated in the body cavity near the spinal column that remove waste products of metabolism from the blood and excrete them in urine. In humans they are bean-shaped organs about 4½ inches (11½ centimeters) long.

Pancreas: A tongue-shaped glandular organ lying below and behind the stomach that secretes insulin, glucagon (both regulate blood sugar) and digestive enzymes.

Segmental pancreas: A portion or section of the pancreas.

Simultaneous deceased-donor pancreas and living-donor kidney transplant (SPLK): The concurrent surgical removal of a deceased-donor pancreas and a living-donor kidney for implantation into a recipient in one surgical procedure.

Simultaneous deceased-donor pancreas/kidney transplant (SPK): The concurrent surgical removal of a pancreas and a kidney from the same deceased donor, and the implantation of the pancreas and kidney into a recipient. This procedure is done for individuals with insulin-dependent diabetes and end-stage renal failure.

Type 1 diabetes: A form of diabetes that usually develops during childhood or adolescence and is characterized by a severe deficiency of insulin secretion resulting from atrophy of the islets of Langerhans and causing hyperglycemia and a marked tendency toward ketoacidosis; also called insulin-dependent diabetes, insulin-dependent diabetes mellitus, juvenile diabetes, juvenile-onset diabetes, type 1 diabetes mellitus.

Uremia: Accumulation in the blood of constituents normally eliminated in the urine that produces a severe toxic condition and usually occurs in severe kidney disease.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Pancreas transplant (PTA, PAK, SPK)
When services may be Medically Necessary when criteria are met:

CPT

 

48550

Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation

48551

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

48552

Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastomosis, each

48554

Transplantation of pancreatic allograft

48556

Removal of transplanted pancreatic allograft

 

 

HCPCS

 

S2065

Simultaneous pancreas kidney transplantation

 

 

ICD-10 Procedure

 

0FYG0Z0

Transplantation of pancreas, allogeneic, open approach

0FYG0Z1

Transplantation of pancreas, syngeneic, open approach

 

 

ICD-10 Diagnosis

 

E10.10-E10.9

Type 1 diabetes mellitus

N18.1-N18.9

Chronic kidney disease (CKD)

T86.890-T86.899

Complications of other transplanted tissue [when specified as pancreas transplant]

Z79.4

Long term (current) use of insulin

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met; for all other diagnoses not listed, for third or subsequent transplantations, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Kidney Transplant (related to pancreas transplant, SPK, SPLK)
When services may be Medically Necessary when criteria are met:

CPT

 

50300

Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral

50320

Donor nephrectomy (including cold preservation); open, from living donor

50323

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

50325

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

50327

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each

50328

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; arterial anastomosis, each

50329

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; ureteral anastomosis, each

50340

Recipient nephrectomy (separate procedure)

50360

Renal allotransplantation, implantation of graft; without recipient nephrectomy

50365

Renal allotransplantation, implantation of graft; with recipient nephrectomy

50547

Laparoscopy, surgical; donor nephrectomy (including cold preservation), from living donor

 

 

ICD-10 Procedure

 

0TY00Z0

Transplantation of right kidney, allogeneic, open approach

0TY00Z1

Transplantation of right kidney, syngeneic, open approach

0TY10Z0

Transplantation of left kidney, allogeneic, open approach

0TY10Z1

Transplantation of left kidney, syngeneic, open approach

 

 

ICD-10 Diagnosis

 

E10.21-E10.29

Type 1 diabetes mellitus with kidney complications

T86.10-T86.19

Complications of kidney transplant

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above for kidney transplantation in association with pancreas transplantation when criteria are not met, for third or subsequent transplantations, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Bunnapradist S, Cho YW, et al. Kidney allograft and patient survival in type I diabetic recipients of cadaveric kidney alone versus simultaneous pancreas/kidney transplants: a multivariate analysis of the UNOS database. J Am Soc Nephrol. 2003; 14:208-213.
  2. Caldara R, La Rocca E, Maffi P, Secchi A. Effects of pancreas transplantation on late complications of diabetes and metabolic effects on pancreas and islet transplantation. J Pedi Endocrin & Metabol. 1999; 12:777-787.
  3. Choi JY, Jung JH, Shin S et al. Association between the pancreas transplantation and survival of patients with diabetes: A single center experience. PLOS One. 2017; 12(11):1-11.
  4. Elliott MD, Kapoor A, et al. Improvement in hypertension in patients with diabetes mellitus after kidney/pancreas transplantation. Circulation.2001; 563-569.
  5. Farney AC, Cho E, et al. Simultaneous cadaver pancreas living donor kidney transplantation: a new approach for the type I diabetic uremic patient. Ann Surg. 2000; 232(5):696-703.
  6. Fioretto P, Steffes MW, et al. Reversal of lesions of diabetic nephropathy after pancreas transplantation. NEJM. 1998; 339(2):69-75.
  7. Fiorina P, LaRocca E, et al. Reversal of left ventricular diastolic dysfunction after kidney-pancreas transplantation in type I diabetic uremic patients. Diabetes Care. 2000; 23(12):1804-1810.
  8. Gruessner AG, Sutherland DE, et al. Pancreas after kidney transplants in posturemic patients with type I diabetes mellitus. J Am Soc Nephrol. 2001; 12:2490-2499.
  9. Humar A, Kandaswamy R, Drangstveit B, et al. Surgical risks and outcome of pancreas retransplants. Surgery. 2000; 127:634-640.
  10. Jukema JW, Smets YF, et al. Impact of simultaneous pancreas and kidney transplantation on progression of coronary atherosclerosis in patients with end-stage renal failure due to type I diabetes. Diabetes Care. 2002; 25(5):906-911.
  11. Kumar A, Newstead CG et al. Combined kidney and pancreatic transplantation: Ideal for patients with uncomplicated type I diabetes and chronic renal failure. Br Med J.1999; 318:886-887.
  12. Lindahl JP, Massey RJ, Hartmann A, et al. Cardiac assessment of patients with type 1 diabetes median 10 years after successful simultaneous pancreas and kidney transplantation compared with living donor kidney transplantation. Transplantation. 2017; 101(6):1261-1267.
  13. Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ.  Chapter 1: Epidemiology of Type 1 Diabetes. Endocrinol Metab Clin North Am. 2010; 39(3):481-497.
  14. Navaro X, Sutherland DE, Kennedy WR. Long-term effects of pancreatic transplantation on diabetic neuropathy. Ann. Neurol. 1998; 44(1):149-150.
  15. Ojo AO, Meier-Kreishe HU, et al. Long-term benefits of kidney-pancreas transplants in type 1 diabetics. Transplant Proc. 2001; 33:1670-1672.
  16. Rayhill Stephen C, D’Alessandro Anthony M, et al. Simultaneous pancreas-kidney transplantation and living related donor renal transplantation in patients with diabetes: Is there a difference in survival? Ann Surg. 2000; 231(3):417-423.
  17. Reddy KS, Stablein D, et al. Long-term survival following simultaneous kidney-pancreas transplantation versus kidney transplantation alone in patients with type I diabetes mellitus and renal failure. Transplant Proc. 2001; 33:1659-1660.
  18. Redmon JB, Teuscher AU, Robertson RP. Hypoglycemia after pancreas transplantation. Diabetes Care. 1998; 21(11):1944-1950.
  19. Robertson RP, Sutherland DE, Lanz KJ. Normoglycemia and preserved insulin secretory reserve in diabetic patients 10-18 years after pancreas transplantation. Diabetes. 1999; 48(9):1737-1740.
  20. Smets YF, Westendorp RG, et al. Effect of simultaneous pancreas-kidney transplantation on mortality of patient with type-1 diabetes mellitus and end-stage renal failure. Lancet. 1999; 353(9168):1915-1919.
  21. Sutherland DE, Gruessner AC. Long-term results after pancreas transplantation. Transplant Proc 2007; 39(7):2323-2325.
  22. Venstrom JM, McBride MA, et al. Survival after pancreas transplantation in patients with diabetes and preserved kidney function. JAMA. 2003; 290(21):2817-2823.
  23. Zielinski A, Nazarewski S, et al. Simultaneous pancreas-kidney transplant from living related donor: a single center experience. Transplantation. 2003; 76(3):547-552.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Diabetes Association: Position Statement: Pancreas transplantation for patients with type 1 diabetes. Diabetes Care. 2004; 27: S105. Available at: http://care.diabetesjournals.org/cgi/content/full/27/suppl_1/s105. Accessed on February 14, 2018.
  2. Centers for Medicare and Medicaid Services. National Coverage Determination for Pancreas Transplants. NCD #260.3. Effective April 26, 2006. Available at: http://www.cms.hhs.gov/mcd/index_chapter_list.asp. Accessed on February 14, 2018.
  3. U.S. Department of Health and Human Services. Organ Procurement and Transplantation Network OPTN). Data Reports. Available at: https://optn.transplant.hrsa.gov/data/view-data-reports/. Accessed on February 14, 2018.
Websites for Additional Information
  1. American Diabetes Association. Pancreas transplantation.  Last updated November 3, 2013. Available at: http://www.diabetes.org/living-with-diabetes/treatment-and-care/transplantation/pancreas-transplantation.html. Accessed February 14, 2018.
  2. National Kidney Foundation. Kidney-Pancreas transplant. Available at: https://www.kidney.org/atoz/content/kidpantx. Accessed on February 14, 2018.
  3. United Network for Organ Sharing. Available at: http://www.unos.org/. Accessed on February 14, 2018.
Index

 

PAK

Pancreas after Kidney Transplant

Pancreas alone Transplant

PTA

Re-Transplantation

Simultaneous Deceased-Donor Pancreas and Living-Donor Kidney Transplant

Simultaneous Pancreas/Kidney Transplant

SPK

SPLK

Type 1 Diabetes

 

Document History

Status

Date

Action

Reviewed

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date”. Rationale, Background/Overview and References sections updated.

Reviewed

05/04/2017

MPTAC review. Updated formatting in Position Statement section. Updated Rationale, References and Websites sections.

Revised

05/05/2016

MPTAC review. Reformatted absolute contraindication section and removed page number from “Note” prior to MN statement. Updated Rationale, Background, References and Website sections. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. Updated Description, Rationale, Background, and References sections.

Reviewed

05/15/2014

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Websites.

Revised

05/09/2013

MPTAC review. Clarified medically necessary statements. Clarified investigational and not medically necessary statement for third or subsequent pancreas or simultaneous pancreas/kidney transplants. Updated Rationale, References, and Websites.

Reviewed

05/10/2012

MPTAC review. Rationale, Reference and Website section updated.

Reviewed

05/19/2011

MPTAC review. References and Websites updated.

Reviewed

05/13/2010

Medical Policy & Technology Assessment Committee (MPTAC) review. Update to rationale and background. References updated.

Reviewed

05/21/2009

MPTAC. References updated.

Reviewed

05/15/2008

MPTAC review. References updated.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

05/17/2007

MPTAC review. Rationale and references updated. 

 

09/14/2006

Added “End Stage Renal Disease (ESRD)” to Definitions.

Reviewed

06/08/2006

MPTAC review.  References updated. 

 

11/21/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Reviewed

07/14/2005

MPTAC review.

Revised

04/28/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

04/27/2004

TRANS.00011

Pancreas Transplantation and Pancreas-Kidney Transplantation

WellPoint Health Networks, Inc.

03/11/2004

7.01.01

Original Title: Simultaneous Pancreas/Kidney Transplant