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108th Congress

Public Laws | arrow indicating current page Pending Legislation

Pancreatic Islet Cell Transplantation Act of 2003

H.R. 1068, S. 518, S. Amendment 1023 to S. 1

Background

Diabetes is a devastating, lifelong condition that affects people of every age, race, and nationality, including approximately 16 million Americans. It is the leading cause of kidney failure, blindness in adults, and amputations unrelated to injury. Moreover, diabetes costs the Nation more than $105 billion a year, 1 out of every 10 health care dollars, in health-related expenditures. In individuals with juvenile diabetes, the bodyís immune system attacks the pancreas and destroys the islet cells that produce insulin. While the discovery of insulin was a breakthrough in the treatment of people with diabetes, it was not a cure. People with juvenile diabetes face the constant threat of developing life-threatening complications as well as facing a drastic reduction in their quality of life.

In 2001, researchers in Edmonton, Alberta, Canada, building on years of research, reported that they had developed methods for harvesting pancreatic islet cells and transplanting these insulin-producing cells into patients with a drug treatment protocol that allowed the majority to become insulin-independent. The National Institutes of Health (NIH), along with the Juvenile Diabetes Research Foundation, is supporting expanded trials of islet transplantation to replicate and build upon the Edmonton methods, which have been hailed as the most important advance in diabetes research since the discovery of insulin in 1921. Of the approximately 70 patients who have been treated using a variation of the Edmonton Protocol during the past 2 years, all have seen a reversal of their life-disabling hypoglycemia, and nearly 80 percent have maintained normal glucose levels without insulin shots for more than 2 years.

New sources of islet cells must be found because of the serious shortage of pancreases available for islet cell transplantation. Only a few thousand cadaveric pancreases are donated annually, and of these only a portion are available for islet transplants. The supply of cadaveric donor islets is sufficient to establish insulin independence in approximately 250 transplant recipients per year in the United States, a number far less than the estimated 1 million individuals with Type 1 diabetes. Moreover, most patients require islet cells from two pancreases for the procedure to work effectively.

Provisions of the Legislation/Impact on NIH

On March 4, 2003, Representative George R. Nethercutt, Jr. (R-WA) introduced H.R. 1068, the Pancreatic Islet Cell Transplantation Act of 2003. H.R. 1068 would permit pancreases procured by organ procurement organizations for the purposes of islet cell transplantation or research to be counted toward that organizationís certification.

The bill would also require the establishment of a U.S. Department of Health and Human Services Interagency Committee on Islet Cell Transplantation. This committee would comprise representatives from the National Institute of Diabetes and Digestive and Kidney Diseases (to serve as chair), National Institute of Allergy and Infectious Diseases, National Institute of Environmental Health Sciences, Health Resources and Services Administration, Centers for Medicare and Medicaid Services, U.S. Department of Defense, U.S. Department of Veterans Affairs, National Aeronautics and Space Administration, and other agencies, and NIH representatives as deemed appropriate by the chair and the Secretary of Health and Human Services (HHS).

The committee would be responsible for 1) conducting a study and reporting the results of the adequacy of Federal funding for research on islet cell transplantation, 2) reviewing current policies and regulations affecting the supply of pancreases, 3) investigating the effect of xenotransplantation on advancing islet cell transplantation and the effect of United Network for Organ Sharing variances on pancreas retrieval and transplantation, and 4) reviewing the existing mechanisms to collect and coordinate outcome data from existing islet cell transplantation trials.

The bill would also require the Secretary of HHS to commission the Institute of Medicine to conduct a study on the impact of islet cell transplantation on the health-related quality of life for individuals with juvenile diabetes and the cost-effectiveness of the treatment. Such sums as may be necessary would be authorized for these activities.

To assess the efficacy of pancreatic islet cell transplantation, the Secretary of HHS would be required to establish a 5-year Medicare demonstration project, which would provide payments for pancreatic islet cell transplantations for Medicare beneficiaries with Type 1 diabetes and end-stage renal disease.

Status and Outlook

H.R. 1068 was introduced on March 4, 2003, and was referred to the House Energy and Commerce Subcommittee on Health.

Companion measure S. 518, the Pancreatic Islet Cell Transplantation Act of 2003, was introduced on March 4, 2003, by Senators Susan M. Collins (R-ME) and Patty Murray (D-WA). S. 518 was referred to the Senate Committee on Health, Education, Labor and Pensions. On June 26, 2003, Senator Collins offered the Medicare Demonstration Project as Senate Amendment 1023 to S. 1, the Medicare Prescription Drug Modernization Act of 2003. Senate Amendment 1023 was passed by the Senate by a voice vote. On July 7, S. 1 was passed by the Senate as H.R. 1, and the bill is currently in conference.

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