NN&I - August 2010

Transplant 28 Nephrology News & Issues August 2010Subscribe to our free eNewsletter at www.nephronline.com ww Making sure patients are properly suited for transplant is not a new concept. Life magazine published an article with photos in 1962 about two committees involved in patient selection for dialysis. The country was surprised to learn such committees controlled access to the limited, life-saving dialysis machines. To make a determination, the first committee, composed of medical professionals, determined which patients had medi-cal necessity and met the standard indications for dialysis treatment. This list was provided to the second group, a com-munity committee, for further evaluation. The first list excluded individuals older than 45, children younger than 18, people with hypertension, vascular complications, or diabetes, and those who were judged to be "emotionally unprepared for the demanding regimen." Patients who passed this first selection moved on to the community committee, which decided their fate. In hindsight, it is not surprising that many if not most of the patients selected for dialysis shared many of the same per-sonal traits and characteristics of the members of the commit- tee: white, employed, family responsibilities, and "good moral character." Fair distribution of organsThe Uniform Anatomical Gift Act in 1968 was the first model law passed by Congress to address anatomical gifts for trans- plant and research. The Act created the "right" for individu-als to donate organs and tissues. It attempted to harmonize the laws at the State level and to align donation policy with medical practices. While the Act was the first national step in developing policy regarding donation, it did not address the issues of organ allocation, patient selection, or listing for organ transplant. In 1984, the U.S. Congress passed the National Organ Transplant Act (NOTA), which established the Organ Procurement and Transplant Network (OPTN). The primary goals of the OPTN, as established by NOTA, are to increase the effectiveness and efficiency of organ sharing throughout the U.S. and reduce the incidence of "wasted" organs, ensure equity and fairness in the distribution of organs, and increase the supply of organs for transplant. During the years following the implementation of NOTA, the transplant community struggled with new and ongoing issues regarding organ allocation and patient selection. For alloca-tion, there was extensive discussion about "local" ownership of locally donated organs versus "broader sharing" among the regions of the country. National and local media began reporting the increasing geographic variations in waiting times for transplantation, especially the critical liver and heart transplants. The survival for those waiting for liver or heart trans-plants often depended on where they were listed. In one region of the country, a patient may wait six months for a liver. In another area of the country the average wait for a liver transplant could be three to four years with many patients dying on the list while waiting. It was recog-nized that under ideal circumstances there would be a suitable donor for every-one who needs one. Despite best efforts, there remained a severe and growing shortage of organs for transplant compared to the increasing number of people who needed organ trans- plants. This shortage varied by geographical area. This disparity of organ donation and its impact on waiting times for transplant continued to be a growing frustration and contributed to the distrust of the national transplant system. In 1999, the HHS "Final Rule" regarding the OPTN was issued to make improvements to the national allocation and transplant system with emphasis on increased and improved technological and methodical operations nationwide. The rule also provided for improved effectiveness of oversight of the current OPTN, and offer better information about transplanta-tion to patients, families, and health care providers. The Final Rule sparked a national and contentious debate among regions of the country and among transplant hospitals. After much dis-cussion, including Congressional hearings and a report from the Institute of Medicine, the Final Rule was implemented. It resulted in broader sharing of donated organs and stipulated that "medical urgency" preempted waiting times for non-renal organs such as liver, heart and lungs in allocation. The Final Rule was a significant effort to address allocation of donated organs for transplant. But the Final Rule did not solve all the issues facing organ donation and transplantation. In its report to Congress, the Institute of Medicine concluded the transplant system should be "managed equitably" across the nation and the federal government has a legitimate and appropriate oversight role to ensure that reasonable standards of equity and quality are met. The IOM report recommended that HHS exercise its legitimate federal oversight of the OPTN assigned to it by NOTA and establish independent scientific review to ensure the system of organ procurement and trans-plantation is "grounded on the best available medical science and is as effective and equitable as possible." C.T. The history of patient selection for therapy for transplantation, especially the critical liver and heart transplants. The survival plants often depended on where they were listed. In one region of the country, a patient may wait six months for a liver. In another area of the country the average wait for a liver transplant could be three there would be a suitable donor for every- Transplant_NNI_0810_3TK.indd 28 7/15/10 6:17:13 PM