|
Medical Policy: 07.03.09
Original Effective Date: November 2009
Reviewed: March 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
The purpose of pancreas transplant is normalization of the diabetic patient’s blood glucose level, thereby preventing eventual microvascular complications. The only effective treatment to restore normal glucose metabolism in patients who are insulin-dependent is beta cell replacement achieved by replacing the pancreas or replacing the pancreatic islet cells. Replacement of the pancreas may be performed alone, following a kidney transplant, or simultaneously with a kidney transplant.
Pancreas transplant alone is indicated for patients with uncontrolled insulin-dependent diabetes yet adequate renal function. The purpose of the transplant is to control the blood glucose levels and prevent diabetes-related complications such as retinopathy, neuropathy, or end-stage renal disease.
Simultaneous pancreas-kidney transplants and pancreas after kidney transplants are performed to correct complications of insulin-dependent diabetes and renal failure in patients who are dependent on dialysis. Patients with insulin-dependent diabetes and impending or established end-stage renal disease who have minimal complications of diabetes are generally considered good candidates for kidney transplant. Kidney transplant is usually recommended for patients with advanced chronic kidney disease as they are highly predisposed to progress to end stage renal disease in a relatively short period of time.
An implantable bioartificial pancreas is a device with a chamber containing glucose-responsive and insulin-secreting islets of Langerhans or similar hormone-secreting cells, one or more vascularizing chambers which open to surrounding tissues. A semi-permeable membrane between the islet and vascularizing chambers allows passage of small molecules including insulin, oxygen and glucose and does not allow passage of agents of the immune system such as white cells and antibodies. The vascularizing chambers containing a growth factor-soaked fibrous matrix allowing small capillary growth and preventing the blood from clotting in the lower chamber.
 Top
Prior Approval:
Prior approval is recommended. Submit a prior approval now.
Top
Policy:
Pancreas alone transplant may be considered medically necessary in patients with insulin-dependent diabetes that is poorly controlled despite maximal medical management and adherence to treatment recommendations.
Pancreas transplant after a prior kidney transplant may be considered medically necessary in patients with insulin-dependent diabetes.
Combined pancreas-kidney transplant may be considered medically necessary in insulin-dependent diabetics with impending or established renal failure.
Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary.
Implantable bioartificial transplant devices are considered investigational.
Except as defined above, candidates for heart/lung transplant should meet the following general criteria:
- Absence of active infection
- Absence of non-curable chronic extrapulmonary infection including chronic active viral hepatitis B, hepatitis C, and human immunodeficiency virus
- Documentation of patient compliance with medical management
The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.
The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy.” In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:
- CD4 count ≥ 200 cells/mm-3 for > 6 months
- HIV-1 RNA undetectable
- On stable anti-retroviral therapy > 3 months
- No other complications from AIDS (e.g., opportunistic infection including aspergillus, tuberculosis, coccidioses mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm)
- Meeting all other criteria for organ transplantation
It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.
Top
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 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
- 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
- S2065; Simultaneous pancreas kidney transplantation
- S2152; 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 posttransplant care in the global definition
Top
Selected References:
- Aguera ML, Navarro MD, Perez-Calderon R et al. Simultaneous pancreas-kidney transplant: a single-center long-term outcome. J Nephrol. 2007 Mar-Apr; 20(2):173-6.
- Bunnapradist S, Cho YW, Cecka JM et al Kidney allograft and patient survival in type 1 diabetic recipients of cadaveric kidney alone versus simultaneous pancreas/kidney transplants: a multivariate analysis of the UNOS database. J Am Soc Nephrol. 2003 Jan;14(1):208-13.
- Humar A, Ramcharan T, Kandaswamy R et al. Pancreas after kidney transplants. Am J Surg. 2001 Aug;182(2):155-61.
- Humar A, Kandaswamy R, Drangstveit MB et al. Surgical risks and outcome of pancreas retransplants. Surgery. 2000 Jun;127(6):634-40.
- Johnson SR, Cherikh WS, Kauffman HM et al. Retransplantation after post-transplant lymphoproliferative disorders: an OPTN/UNOS database analysis. Am J Transplant. 2006 Nov;6(11):2743-9.
- Kizilel S, Garfinkel M, Opara E. The bioartificial pancreas: progress and challenges. Diabetes Technol Ther. 2005 Dec;7(6):968-85.
- Lipshutz GS, Wilkinson AH. Pancreas-kidney and pancreas transplantation for the treatment of diabetes mellitus. Endocrinol Metab Clin North Am. 2007 Dec;36(4):1015-38.
- Sutherland DE, Gruessner AC. Long-term results after pancreas transplantation. Transplant Proc 2007;39(7):2323-5.
- 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 2008;86(12):1789-94.
- Hirshberg B. The cardinal features of recurrent autoimmunity in simultaneous pancreas-kidney transplant recipients. Curr Diab Rep 2010; 10(5):321-2.
- Fridell JA, Mangus RS, Hollinger EF et al. The case for pancreas after kidney transplantation. Clin Transplant 2009; 23(4):447-53.
- 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):437-46.
- Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in patients older than 50 years. Transpl Int. 2011 Feb; 24(2):136-42. doi: 10.1111/j.1432-2277.2010.01172.x. Epub 2010 Oct 13.
- Afaneh C, Rich BS, Aull MJ et al. Pancreas transplantation: does age increase morbidity? J transplant. 2011; 2011:596801. Epub 2011 Jun 4.
- 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 (IPTR). Rev Diabet Stud. 2011 Spring; 8(1):6-16. Epub 2011 May 10.
- Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic recipients. Clin J AM Soc Nephrol. 2011 May;6(5):1198-206. Epub 2011 Mar 24.
Top
Policy History:
Date Reason Action
April 2011 Annual review Policy renewed
March 2012 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
|
 |
