National Institutes of Health, NIDDK, Natcher Building, Room 6AN32, Bethesda, MD 20892

A -- PANCREAS AND ISLET TRANSPLANT DATABASE POC Contact Point: Danielle C. Sweeney, Contract Specialist, 301-594- 8838. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) plans to increase the support for the contract with the University of Minnesota Medical School. These changes are the result from the Health Care Financing Administration (HCFA) to the NIDDK under which the NIDDK will study the effectiveness of simultaneous pancreas-kidney transplants (SPK) on the secondary complications of diabetes and will provide the results to HCFA in order that it may determine whether SPK should be considered "reasonable and necessary" under the Medicare program. The NIDDK will continue to sponsor a multi-center patient registry to determine the long-term efficacy of SPK on the secondary complications of diabetes. As a control group, NIDDK will begin to collect equivalent data on diabetic patients receiving a kidney only. NIDDK will also develop patient selection criteria for pancreas transplants from the database and will provide the results of the registry to HCFA in order for them to determine whetherand under what circumstances and conditions SPK is reasonable and necessary, and therefore, covered under the Medicare Program. Because of this joint effort with HCFA, the NIDDK contract will obtain more complete data on the pancreas transplant patients. Thus, enabling NIDDK to have a complete evaluation of the efficacy of pancreas transplantation on the secondary complications of diabetes. Determination to use other than full and open competition was made in accordance with 41 U.S.C. (c) (1) as set forth in FAR 6.302-1. See Note 22**** (0205)

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