Financial issues constraining the use of pancreata recovered for islet transplantation: a white paper.

Islet transplantation is a very promising therapy for select patients with type 1 diabetes. Continued clinical investigation is required to define the long-term safety and efficacy outcomes before the procedure will be accepted as a standard of care even for those with the most severe manifestations of diabetes. Threatening successful accomplishment of these and other innovative studies designed to advance the field are the complex financial cost accounting issues that pose undue burden on organ procurement organizations and transplant centers trying to manage the costs of the pancreata from deceased donors needed to isolate islets. Compounding the problem is the recent ruling by CMS regarding 'intent to transplant' (CMS-1543-R Dec. 21, 2006: Allocation of Donor Acquisition Costs Incurred by Organ Procurement Organizations) that does not account for the clinical need to complete the manufacturing process for islets before suitability and transplant intent of the pancreata involved can be determined. We provide a consensus document supported by a diverse group of stakeholders in islet transplantation to suggest actions to address this problem.