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Date Printed: October 21, 2017: 11:36 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-17

Original Effective Date: 07/15/02

Reviewed: 12/04/14

Revised: 12/15/14

Subject: Allogeneic Pancreas Transplant

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates    

DESCRIPTION:

Transplantation of a normal pancreas is a treatment method for patients with insulin-dependent diabetes mellitus. Pancreas transplantation can restore glucose control and is intended to prevent, halt, or reverse the secondary complications from diabetes mellitus.

Achievement of insulin independence with resultant decreased morbidity and increased quality of life is the primary health outcome of pancreas transplantation. While pancreas transplantation is generally not considered a life-saving treatment, in a small subset of individuals who experience life-threatening complications from diabetes, pancreas transplantation could be considered life-saving. Pancreas transplant alone (PTA) has also been investigated in individuals following total pancreatectomy for chronic pancreatitis. In addition to the immune rejection issues common to all allograft transplants, autoimmune destruction of beta cells has been observed in the transplanted pancreas, presumably from the same mechanism responsible for type 1 diabetes.

Pancreas transplantation occurs in several different scenarios such as: (1) a diabetic individual with renal failure who may receive a cadaveric simultaneous pancreas/kidney transplant (SPK); (2) a diabetic individual who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney, ie, PAK); or (3) a nonuremic diabetic individual with specific severely disabling and potentially life-threatening diabetic problems who may receive a PTA.

The approach to retransplantation varies according to the cause of failure. There are no standard guidelines for multiple pancreas transplants. If there is early graft loss resulting from technical factors (eg, 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.

POSITION STATEMENT:

 

Certificate of Medical Necessity

The transplant facility should submit a completed Certificate of Medical Necessity (CMN) along with your request for transplant services to expedite the medical review process.

1. Click this link Solid Organ Transplant - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Pancreas transplant alone (PTA) meets the definition of medical necessity when the following conditions are met:

• Insulin dependent diabetes, AND

• Severely disabling and potentially life-threatening complications due to hypoglycemia unawareness, AND

Labile diabetes that persists despite optimal medical management, AND

• ONE of the following:

o Documentation of severe hypoglycemia unawareness by office notes or emergency department visits, OR

o Documentation of potentially life-threatening labile diabetes, by office notes or hospitalization for diabetic ketoacidosis.

Simultaneous pancreas-kidney transplant (SPK) meets the definition of medical necessity in individuals with end stage renal disease (ESRD) and insulin-dependent diabetes.

Pancreas transplant after a prior kidney transplant (PAK) meets the definition of medical necessity in individuals with insulin-dependent diabetes who meet the criteria above for PTA.

Pancreas, pancreas-kidney and pancreas after kidney retransplantation after a failed primary transplant meets the definition of medical necessity in individuals who meet the criteria above for PTA, SPK or PAK.

Pancreas, pancreas-kidney and pancreas after kidney transplantation is considered experimental or investigational in all other situations, as available clinical evidence does not support safety and effectiveness.

Potential contraindications to pancreas and pancreas-kidney transplant (subject to the judgment of the transplant center) include:

• Known current malignancy, including metastatic cancer

• Recent malignancy with high risk of recurrence

• Untreated systemic infection making immunosuppression unsafe, including chronic infection

• Other irreversible end-stage disease not attributed to kidney disease

• History of cancer with a moderate risk of recurrence

• Systemic disease that could be exacerbated by immunosuppression

• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Transplant associated services which meet the definition of medical necessity include:

• Hospitalization of the recipient for medically recognized transplants from a donor to a transplant recipient

• Evaluation tests requiring hospitalization to determine the suitability of both potential and actual donors, when such tests cannot be safely and effectively performed on an outpatient basis

• Hospital room, board, and general nursing in semi-private rooms

• Special care units, such as coronary and intensive care

• Hospital ancillary services

• Physicians’ services for surgery, technical assistance, administration of anesthetics, and medical care

• Acquisition, preparation, transportation, and storage of organ

• Diagnostic services

• Drugs that require a prescription by federal law.

BILLING/CODING INFORMATION:

CPT Coding:

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 anastomosis 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

50360

Renal allotransplantation, implantation of graft; without recipient nephrectomy

50365

Renal allotransplantation, implantation of graft with recipient nephrectomy

HCPCS Coding:

S2065

Simultaneous pancreas kidney transplantation

REIMBURSEMENT INFORMATION:

None indicated.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Pancreas Transplants (260.3), located at cms.gov.

DEFINITIONS:

End Stage Renal Disease (ESRD): The terms end-stage renal failure and end-stage renal disease are used interchangeably; there is persistent decline in renal function with falling creatinine clearance in an individual who is expected to progress to requiring dialysis or transplant. Typically, those with ESRD will have kidney function in the area of 10-15%.

Hypoglycemia unawareness: A condition in which a person with diabetes doesn't experience the usual warning symptoms of hypoglycemia; may lead to confusion, disorientation or loss of consciousness.

Labile diabetes: Diabetes that is particularly hard to control, with frequent, extreme swings in blood glucose levels; also called brittle diabetes.

Uremia: Accumulation in the blood of constituents normally eliminated in the urine, producing a severe toxic condition and usually occuring in severe kidney disease.

RELATED GUIDELINES:

Kidney Transplantation, 02-50300-01
Small Bowel, Liver and Multivisceral Transplant, 02-40000-19

OTHER:

None applicable.

REFERENCES:

  1. American Diabetes Association. Pancreas transplantation for patients with type 1 diabetes (Position Statement). Diabetes Care. 2003; 26 (Suppl 1): S120.
  2. Andreoni KA, et al. Kidney and pancreas transplantation in the United States, 1996-2005. American Journal of Transplantation 2007; 7 (part 2): 1359-1375.
  3. Banga N, et al. Outcome of surgical complications following simultaneous pancreas–kidney transplantation. Nephrol Dial Transplant (2012) 27: 1658–1663.
  4. Barnes Jewish Hospital Transplant Center. Simultaneous Pancreas/Kidney (SPK) Transplantation Candidate Criteria. Accessed at http://www.barnesjewish.org/criteria-for-kidney-pancreas-transplant.
  5. Blue Cross Blue Shield Association policy 7.03.02 – Pancreas Transplant (February 2014).
  6. Blue Cross Blue Shield Association Technology Evaluation Center assessment – Pancreas Transplantation (1998).
  7. Blue Cross Blue Shield Association Technology Evaluation Center assessment – Pancreas Retransplantation (2001).
  8. Blue Cross Blue Shield of Florida Technology Assessment Summary – Pancreas Transplantation (05/95; 09/99).
  9. Canadian Agency for Drugs and Technology in Health. Pancreas Transplantation to Restore Glucose Control: Review of Clinical and Economic Evidence. 2007. Accessed at: http://cadth.ca/media/pdf/I3005_Pancreatic_Transplantation_tr_e.pdf on 04/25/14.
  10. Centers for Medicare and Medicaid Services (CMS) decision memo published 04/26/06.
  11. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination Manual, Publication 100-3, Section 260.3, Pancreas Transplants (04/26/06).
  12. ECRI Hotline Response article: “Pancreas Transplantation Alone” (01/21/05).
  13. ECRI Windows on Medical Technology, Issue No. 90: “Living Donor Pancreas Transplantation” (11/99).
  14. Florida Medicare Part B Medical Policy 48544 – Pancreas Transplantation (10/01/02). (Retired)
  15. Fourtounas C. Transplant options for patients with type 2 diabetes and chronic kidney disease. World J Transplant 2014 June 24; 4(2): 102-110.
  16. Gaston RS, et al. Transplantation in the Diabetic with Advanced Chronic Kidney Disease: A Task Force Report. Am J Kidney Dis44: 529-542.
  17. Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be restricted because of age. Transplant Int 2011; 24(2):134-35.
  18. 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.
  19. HAYES, Inc. Medical Technology Directory. Pancreas After Kidney Transplantation. Lansdale, PA: Hayes Inc: 06/30/06 (updated 07/27/07).
  20. HAYES, Inc. Medical Technology Directory. Pancreas Transplantation, Alone and After Kidney Transplantation. Lansdale, PA: Hayes Inc. (PAK, 02/26/99; PTA 03/1/99; updated 08/13/03).
  21. HAYES, Inc. Medical Technology Directory. Pancreas Transplantation Alone. Lansdale, PA: Hayes Inc. 02/27/06 (updated 03/04/08).
  22. HAYES, Inc. Medical Technology Directory. Simultaneous Pancreas-Kidney Transplantation in Diabetic Patients Lansdale, PA: Hayes Inc: 06/21/06 (updated 01/22/08).
  23. Isla Pera A, et al. Impact of simultaneous pancreas-kidney transplantation: patients’ perspectives. Patient Preference and Adherence 2012:6 597–603.
  24. Jiang AT, et al. Simultaneous pancreas-kidney transplantation: The role in the treatment of type 1 diabetes and end-stage renal disease. Can Urol Assoc J 2014;8(3-4):135-8.
  25. Johns Hopkins Medicine Comprehensive Transplant Center. Kidney and Pancreas Patient Selection Criteria. Accessed at http://www.hopkinsmedicine.org/transplant/referring_physicians/patient_selection_criteria/kidney_pancreas.html.
  26. Khairoun M, et al. Microvascular Damage in Type 1 Diabetic Patients Is Reversed in the First Year After Simultaneous Pancreas–Kidney Transplantation. American Journal of Transplantation 2013; 13: 1093–1281.
  27. Mai ML, et al. The long-term management of pancreas transplantation. Transplantation 2006; 82: 991-1003.
  28. National Kidney Foundation. Kidney-Pancreas Transplant. Accessed at https://www.kidney.org/atoz/content/kidpantx.
  29. Organ Procurement and Transplantation Network (OPTN). Kaplan-Meier Graft Survival Rates For Transplants Performed 1997 – 2004. Accessed at: http://optn.transplant.hrsa.gov/latestData/viewDataReports.asp on 04/25/14.
  30. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic patients. Clin J Am Soc Nephrol 2011; 6(5):1198-206.
  31. Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in patients older than 50 years. Transplant Int 2011; 24(2):136-42.
  32. Tampa General Hospital Transplant Center. Pancreas Transplant Selection Criteria. Accessed at https://www.tgh.org/pancreas-transplant-selection-criteria/.
  33. UCLA Health School of Medicine Transplantation Services. Selection Criteria for Kidney/Pancreas Transplantation. Accessed at http://transplants.ucla.edu/body.cfm?id=81.
  34. United Network of Organ Sharing (UNOS) Policy (accessed 05/13/08).
  35. University of Maryland Transplant Center. Simultaneous Kidney/Pancreas Transplant (September 2014). Accessed at http://umm.edu/programs/transplant/services/kidney-pancreas/indications.
  36. Organ Procurement and Transplantation Network Policies (04/10/14). Accessed at: http://optn.transplant.hrsa.gov/policiesAndBylaws/policies.asp on 04/26/14.
  37. Organ Procurement and Transplantation Network (OPTN) Policies: Organ distribution: pancreas allocation. Updated 2013 Jul 25. Accessed at: http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_10.pdf on 04/25/14.
  38. van Dellen D, Worthington J, Mitu-Pretorian OM et al. Mortality in diabetes: pancreas transplantation is associated with significant survival benefit. Nephrol Dial Transplant 2013; 28(5):1315-22.
  39. Waki K, et al. Long-Term Pancreas Allograft Survival in Simultaneous Pancreas-Kidney Transplantation by Era. Diabetes Care 33:1789–1791, 2010.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/04/14.

GUIDELINE UPDATE INFORMATION:

07/15/01

Medical Coverage Guideline Reformatted.

03/15/02

Change to covered services section.

06/15/03

Reviewed; removed investigational statement for islet cell transplantation for development of separate MCG.

04/15/04

Scheduled review with formatting revisions; added investigational statement regarding transplants in HIV-positive recipients.

01/01/05

HCPCS coding update: added new codes 48551 and 48552; revised code 48550 descriptor.

04/15/05

Scheduled review; no change in coverage statement.

06/15/05

Revision of guideline, consisting of removal of investigational statement regarding HIV-positive recipients.

06/15/06

Scheduled review; no change in coverage statement.

06/15/07

Scheduled review; reformatted guideline; updated references.

07/15/08

Scheduled review. Delete experimental or investigational position for 2 or more failed pancreas transplants. Add language for multiple transplants. Update references.

06/15/09

Scheduled review; no change in position statement.

06/15/10

Annual review; no change in position statement. References updated.

06/15/14

Scheduled review. Revised MCG title, description, position statement, program exceptions and definitions section. Updated references.

12/15/14

Unscheduled review. Revised position statement (SPK criteria). Revised definitions and updated references.

Date Printed: October 21, 2017: 11:36 AM