Latest Review Date: August 2024

Category:  Surgery                                                                

POLICY:

Pancreas transplant after a prior kidney transplant may be considered medically necessary in individuals with insulin dependent diabetes.

A combined pancreas-kidney transplant may be considered medically necessary in insulin dependent diabetic individuals with uremia.

Pancreas transplant alone may be considered medically necessary in individuals with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists despite optimal medical management.

Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary in individuals who meet criteria for pancreas transplantation.

Pancreas transplant is considered investigational in all other situations.

POLICY GUIDELINES:

General Criteria

Potential contraindications for solid organ transplant that are subject to the judgment of the transplant center include the following:

• Known current malignancy, including metastatic cancer;
• Recent malignancy with a high incidence of recurrence;
• History of cancer with a moderate risk of recurrence;
• Systemic disease that could be exacerbated by immunosuppression;
• Untreated systemic infection making immunosuppression unsafe, including chronic infection;
• Other irreversible end-stage disease not attributed to kidney disease; 
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Pancreas-Specific Criteria

Candidates for pancreas transplant alone should also meet one of the following severity of illness criteria:

• Documented severe hypoglycemia unawareness as evidenced by chart notes or emergency department visits or
• Documented potentially life-threatening labile diabetes, as evidenced by chart notes or hospitalization for diabetic ketoacidosis.

Additionally, most pancreas transplant individuals will have type 1 diabetes. In 2022, individuals with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.

Multiple Transplants

Although there are no standard guidelines for multiple pancreas transplants, the following information should be considered:

• If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a retransplant may generally be performed without substantial additional risk.
• Long-term graft losses may result from chronic rejection, which is associated with increased risk of infection following long-term immunosuppression, and sensitization, which increases the difficulty of finding a negative cross-match. Some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.

DESCRIPTION OF PROCEDURE OR SERVICE:

Solid organ transplantation offers a treatment option for individuals with different types of end-stage organ failure that can be lifesaving or provide significant improvements to an individual’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Individuals are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Allogeneic Pancreas Transplant

In 2023, 46,630 transplants were performed in the United States procured from almost 16,000 deceased donors and 6,900 living donors. Pancreas-kidney transplants were the fifth most common procedure, with 812 transplants performed in 2023. Pancreas-alone transplants were the sixth most common procedure, with 102 transplants performed in 2023.

Pancreas transplantation occurs in several different scenarios such as (1) a diabetic individual with renal failure who may receive a simultaneous cadaveric pancreas plus kidney transplant; (2) a diabetic individual who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney); or (3) a non-uremic diabetic individual with specific severely disabling and potentially life-threatening diabetic problems who may receive a pancreas transplant alone.

Data from the United Network for Organ Sharing and the International Pancreas Transplant Registry indicate that the proportion of simultaneous pancreas plus kidney transplant recipients worldwide who have type 2 diabetes has increased over time, from 6% of transplants between 2005 and 2009 to 9% of transplants between 2010 and 2014.  Between 2010 and 2014, approximately 4% of pancreas after kidney transplants and 4% of pancreas alone transplants were performed in individuals with type 2 diabetes. In 2022, individuals with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients. 

KEY POINTS:

The most recent literature update was performed through June 24, 2024.

Summary of Evidence

For individuals who have insulin-dependent diabetes who receive a pancreas transplant after a kidney transplant, the evidence includes retrospective studies and registry studies. Relevant outcomes are overall survival (OS), change in disease status, and treatment-related mortality and morbidity. Data from national and international registries have found relatively high individual survival rates with a pancreas transplant after a kidney transplant (e.g., a 3-year survival rate of 94.5%). Single-center retrospective studies have found similar individual survival and death-censored pancreas graft survival rates with a pancreas transplant after a kidney transplant or a simultaneous pancreas and kidney (SPK) transplant. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have insulin-dependent diabetes with uremia who receive SPK transplants, the evidence includes retrospective studies and registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. Data from national and international registries have found relatively high individual survival rates after SPK transplant. A retrospective analysis found a higher survival rate in individuals with type 1 diabetes who had an SPK transplant versus those on a waiting list. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have insulin-dependent diabetes and severe complications who receive pancreas transplant alone, the evidence includes registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. Data from international and national registries have found that graft and individual survival rates after pancreas transplant alone have improved over time (e.g., 3-year survival of 94.9%). The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have had a prior pancreas transplant who still meet criteria for a pancreas transplant who receive pancreas retransplantation, the evidence includes retrospective studies and registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. National data and specific transplant center data have generally found similar graft and individual survival rates after pancreas retransplantation compared with initial transplantation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

The Organ Procurement and Transplantation Network

The Organ Procurement and Transplantation Network updated its comprehensive list of transplant-related policies, most recently in May 2024.

For pancreas registration:

“Each candidate registered on the pancreas waiting list must meet one of the following  requirements:

• Be diagnosed with diabetes
• Have pancreatic exocrine insufficiency
• Require the procurement or transplantation of a pancreas as part of a multiple organ  transplant for technical reasons.”

For combined kidney plus pancreas registration: “Each candidate registered on the kidney-pancreas waiting list must be diagnosed with diabetes or have pancreatic exocrine insufficiency with renal insufficiency.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Pancreas after Kidney Transplant, PAK, Simultaneous Pancreas/Kidney Transplant, SPK, Pancreas Retransplantation, Pancreas Transplant Alone, PTA, Transplant, Pancreas, Pancreas/Kidney

APPROVED BY GOVERNING BODIES:

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).

The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Coding:

HCPCS Coding:

REFERENCES:

1. Afaneh C, Rich BS, Aull MJ et al. Pancreas transplantation: does age increase mortality?  J Transplant 2011; 2011:596801.
2. Barlow AD, Saeb-Parsy K, Watson CJE. An analysis of the survival outcomes of simultaneous pancreas and kidney transplantation compared to live donor kidney transplantation in patients with type 1 diabetes: a UK Transplant Registry study. Transpl Int. Sep 2017; 30(9):884-892.
3. Bazerbachi F, Selzner M, Marquez MA et al. Pancreas-After-Kidney versus Synchronous Pancreas- Kidney Transplantation: Comparison of Intermediate-Term Results. Transplantation. Feb 15 2013; 95(3):489-494.
4. Black CK, Termanini KM, Aguirre O, et al. Solid organ transplantation in the 21-st century. Ann Transl Med. Oct 2018; 6(20): 409.
5. Blue Cross Blue Shield Association. Pancreas Retransplantation. Technology Evaluation Center (TEC) 2001 Assessment; Volume 16, Tab 23.
6. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) 1998 Assessment; Volume 13, Tab 7.
7. Blumberg EA, Rogers CC. Solid organ transplantation in the HIV-infected patient: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep; 33(9). e13499
8. Boggi U, Baronti W, Amorese G, et al. Treating Type 1 Diabetes by Pancreas Transplant Alone: a Cohort Study on Actual Long-Term(10 Years) Efficacy and Safety. Transplantation. Jan 01 2022; 106(1): 147-157.
9. Buron F, Thaunat O, Demuylder-Mischler S et al. Pancreas Retransplantation: A Second Chance for Diabetic Patients? Transplantation. Jan 27 2013; 95(2):347-352.
10. Fridell JA, Mangus RS, Chen JM, et al. Late pancreas retransplantation. Clin Transplant. Jan 2015; 29(1):1-8.
11. Fridell JA, Mangus RS, Hollinger EF et al. The case for pancreas after kidney transplantation. Clin Transplant 2009; 23(4):447-453.
12. Gasteiger S, Cardini B, Göbel G, et al. Outcomes of pancreas retransplantation in patients with pancreas graft failure. Br J Surg. 2018 Dec; 105 (13):1816-1824.
13. Gruessner AC, Gruessner RW. Pancreas Transplantation of US and Non-US Cases from 2005 to 2014 as Reported to the United Network for Organ Sharing (UNOS) and the International Pancreas Transplant Registry (IPTR). Rev Diabet Stud. Spring 2016; 13(1):35-58.
14. Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be restricted because of age: invited commentary on Schenker et al.  Transplant Int 2011; 24(2):134-135.
15. 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.  
16. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
17. Kandaswamy R, Stock PG, Gustafson SK et al. OPTN/SRTR 2022 Annual Data Report: Pancreas. Am. J. Transplant. Feb 2024; 24(2S1): S119-S175
18. Kandaswamy R, Stock PG, Miller J, et al. OPTN/SRTR 2019 Annual Data Report: Pancreas. Am J Transplant. Feb 2021; 21 Suppl 2:138-207.
19. 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):437-446.
20. Organ Procurement and Transplantation Network (OPTN). National Data. n.d.; optn.transplant.hrsa.gov/data/view-data-reports/national-data/.
21. Organ Procurement and Transplantation Network (OPTN). OPTN Policies. optn.transplant.hrsa.gov/media/1200/optn_policies.pdf.
22. Parajuli S, Arunachalam A, Swanson KJ et al. Outcomes after simultaneous kidney-pancreas versus pancreas after kidney transplantation in the current era. Clin Transplant. 2019 Dec; 33(12). e13732.
23. Parajuli S, Arunachalam A, Swanson KJ et al. Pancreas Retransplant After Pancreas Graft Failure in Simultaneous Pancreas-kidney Transplants Is Associated With Better Kidney Graft Survival. Transplant Direct. 2019 Aug; 5(8). e473.
24. Pugliese A, Reijonen HK, Nepom J, et al. Recurrence of autoimmunity in pancreas transplant patients: research update. Diabetes Manag (Lond). Mar 2011; 1(2): 229-238.
25. Rudolph EN, Finger EB, Chandolias N, et al. Outcomes of pancreas retransplantation. Transplantation. Feb 2015; 99(2):367-374.
26. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in Type II diabetic patients. Clin J Am Soc Nephrol. May 2011; 6(5):1198-1206.
27. Scalea JR, Burler CC, Munivenkatappa RB et al. Pancreas transplant alone as an independent risk factor for the development of renal failure: a retrospective study. Transplantation. Dec 27 2008; 86(12):1789-1794.
28. Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in patients older than 50 years. Transplant Int. Feb 2011; 24(2):136-142.
29. Seal J, Selzner M, Laurence J, et al. Outcomes of Pancreas Retransplantation After Simultaneous Kidney-Pancreas Transplantation Are Comparable to Pancreas After Kidney Transplantation Alone. Transplantation. Mar 2015; 99(3):623-628.
30. Shah AP, Mangus RS, Powelson JA et al. Impact of recipient age on whole organ pancreas transplantation. Clin Transplant 2013; 27(1):E49-55.
31. Siskind E, Maloney C, Akerman M, et al. An analysis of pancreas transplantation outcomes based on age groupings--an update of the UNOS database. Clin Transplant. Sep 2014; 28(9):990-994.
32. United Network for Organ Sharing (UNOS). Transplant trends. 2024; unos.org/data/transplant-trends/.
33. Van dellen D, Worthington J, Mitu-Pretorian OM et al. Mortality in diabetes: pancreas transplantation is associated with significant survival benefit. Nephrol Dial Transplant. May 2013; 28(5):1315-1322.

POLICY HISTORY:

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, June 2011 (1): Update to Description, Policy, Key Points and References related to non-coverage criteria for pancreas transplant, redefining general coverage criteria and adding contraindication language.

Medical Policy Administration Committee, July 2011

Available for comment July 6 through August 22, 2011

Medical Policy Group, February 2012 (3): 2012 Update; Policy, Key Points, References

Medical Policy Administration Committee, February 2012

Available for comment February 22 through April 6, 2012

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3):  2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (3): 2014 Updates to Description, Policy Statement, Key Points & References; policy statement update to add, “Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary in patients who meet criteria for pancreas transplantation.”

Available for comment March 1 through April 14, 2014

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (2): 2015 Updates to Key Points, Practice Guidelines and Position Statements, and References, no change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (7): 2017 Updates to Description, Key Points and References. Policy statement- Added HIV criteria; clarified absolute contraindications; removed old criteria from 2012 and 2014.

Medical Policy Administration Committee Meeting October 2017

Available for comment September 29 through November 12, 2017

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Description, Key Points, Approved by Governing Bodies, References, and Key Words: (added Simultaneous Pancreas/Kidney Transplant, SPK, PAK and PTA). No change to policy statement or intent.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Description, Key Points, Practice Guidelines and Position Statement and References. No changes to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (3): 2021 Updates to Description, Key Points and References. Policy statement updated to remove “not medically necessary”, no other changes to policy statement.

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (3): 2022 Updates Description, Key Points, Practice Guidelines and Position Statements, and References. Moved policy criteria for candidates with type 2 diabetes requiring (body mass index ≤32 kg/m2) with insulin dependency to the policy guidelines. Removed HIV positive patient criteria from policy section to reflect standard of care guidelines from the American Society of Transplantation. Removed absolute contraindications in policy guidelines and changed verbiage to “Potential contraindications to solid organ transplant (subject to the judgment of the transplant center).” No other changes to policy statement or intent.

Medical Policy Panel, August 2023

Medical Policy group, August 2023 (3): 2023 Updates to Description, Key Points, Practice Guidelines and Position Statements, Benefit Applications, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (3): Updates to Description, Key Points, and References. Policy Guidelines statement updated removed the verbiage“ Those transplant candidates with type 2 diabetes, in addition to being insulin-dependent, should also not be obese (body mass index should be ≤32 kg/m2).” No change to the policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.