Advances in modern medicine have made organ transplantation a viable, effective, and economical option for thousands of individuals annually. The types of organs transplanted include kidneys, livers, hearts, lungs, intestines, and pancreases, although kidneys and livers are the most common organs transplanted. According to August 2007 data provided by the United Network for Organ Sharing (UNOS), there are 96,696 individuals registered with the Organ Procurement and Transplantation Network (OPTN) national patient waiting list.

The high demand for organs, however, is outstripping the supply of organs available. Recent statistics indicate that there are roughly 56 organ transplants performed daily and approximately 19 deaths among those awaiting a transplant. During 2006, there were 28,934 transplants performed out of approximately 100,000 patient registrations, and 6,229 patients died while registered with the OPTN waiting list. Over the past decade alone, the OPTN waiting list has increased by more than 50,000 patients, as patient access to transplantation options has outpaced the growth in supply of organs available. Subsequently, public and private stakeholders have been required to pursue new programs and policies in order to alleviate the current shortage of organs, while ensuring that the organ distribution system remains free of unethical or inequitable practices that could unfairly benefit some patients and penalize others.

The first organ transplant was performed in 1954, although transplantation activities remained mostly free from federal oversight until 1972, when legislation was enacted to provide coverage for kidney transplants through Medicare. As transplant activities increased, Congress identified a need for more stringent federal oversight. In 1984, the National Organ Transplant Act (NOTA) (P.L. 98-507) was enacted to both provide an effective regulatory mechanism over the transplant community and policies for allocating organs in an equitable manner throughout the population. It also prohibits the buying or selling of human organs used in transplantation in exchange for “valuable consideration,” although the definition of the term has been debated.

The OPTN is charged with several responsibilities, including: the development of policies to ensure the equitable allocation of organs; to maintain updated waiting lists of potential organ recipients; and to develop and evaluate statistical data on transplant centers and programs. The OPTN is administered under contract by the United Network for Organ Sharing (UNOS), and is overseen by the Division of Transplantation (DoT) within the Health Resources and Services Administration (HRSA) at HHS.

The Centers for Medicare and Medicaid Services (CMS) also has regulatory authority over transplant centers and OPOs for the purpose of providing coverage under Medicare. Membership of the OPTN primarily consists of hospital transplant centers and Organ Procurement Organizations (OPOs) that recover organs within an established geographical area. As of June 2007, there are 412 members of the OPTN, including 257 transplant centers, 58 OPOs, and other stakeholder groups such as histocompatibility laboratories, medical or scientific organizations, and public members.