Organ Procurement and Transplantation Assessing Current Policies and the Potential Impact of the DHHS Final Rule (1999) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-30
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From page 17... ...
Ischemic injury results from prolonged lack of blood flow, and, at some point, affects organ function following transplantation. The amount of ischemia that compromises organ function differs by organ type and other factors, for example, donor age.
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HCFA also approves waivers that permit a hospital to have an arrangement with a different OPO than the one assigned to its area. EVOLUTION OF THE FEDERAL SYSTEM OF ORGAN TRANSPLANTATION The current arrangement of 62 organ procurement organizations nationally evolved gradually, reflecting improvements in transplantation science, organ preservation, and other factors.
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TABLE 1-2 UNOS National Patient Waiting List for Organ Transplants .
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20 oo l oo Ct Ct Ct o 4_ ._ .s ·_I Cal 3 Ct U)
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Delaware Valley Transplant Program 13. Virginia Organ Procurement Agency 14.
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The origin of the current system is the National Organ Transplant Act of 1984, which created a national transplant system to be operated by transplant professionals, with oversight by DHHS to ensure an equitable allocation system. The act created the Organ Procurement and Transplantation Network (OPTN)
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The issue of appropriate federal oversight of the system including procedures for joining the OPTN, the federal review processes, procedures and standards for information collection and dissemination, OPTN membership requirements and compliance procedures, and the criteria for allocation of each of the solid organs has been a subject of debate since that time. The DHHS proposal, 42 CFR Part 121, "Organ Procurement and Transplantation Network; Final Rule" (DHHS, 1998b)
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From page 24... ...
In the Final Rule, DHHS claims that by allocating organs primarily at the local level, current policies give some of the most medically urgent patients a substantially lower chance of being promptly matched to a suitable organ (and thereby receiving a potentially lifesaving transplant) than would be the case with broader geographic sharing.
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Procedural Requirements Procedural requirements contained in the Final Rule include: Transition to New Policies-When the OPEN initially revises organ allocation policies, it must propose transition policies ensuring that people who are already on the national waiting list for transplantation do not receive less favorable treatment than they would have under previous policies. Board Composition The Final Rule modifies the composition of the OPTN Board of Directors.
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From page 26... ...
organ allocation policies that give priority to those whose needs are most medically urgent, in accordance with sound medical judgment, with the result that differences in waiting times for patients of like medical status will be reduced. Finally, the Final Rule requires the OPTN board to focus first on appropriate revisions to its current liver allocation policy and to propose a new liver allocation policy to the secretary within 60 days of the regulation's effective date.
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From page 27... ...
Opponents of the Final Rule assert that "a sickest first policy would create a system that is wasteful and dangerous, resulting in fewer patients transplanted, increased death rates, increased retransplantation due to poor organ function, and increased overall cost of transplantation" (Benjamin, 1999~. Some opponents of the Final Rule object in particular to the proposed ability of the DIMS Secretary to make OPEN allocation policies and direct the OPTN to implement them, claiming this will replace medical judgment with political judgment.
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impact of recent changes made by the OPEN in patient listing criteria and in measures of medical status; · patient survival rates and organ failure rates leading to retransplantation, including variances by income status, ethnicity, gender, race, or blood type; and . costs of organ transplantation services.
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Liver allocation policies have been especially contentious, with the OPTN making several changes in policies in the recent past; · Because the maximum desirable cold ischemic time for hearts and lungs is 3 - hours, there is less opportunity to make significant changes in the current allocation rules for them than there is for livers, which have a longer ischemic time; and . The medical urgency of transplanting livers differs from that for some of the other solid organs, e.g., kidneys (those waiting for livers are often terminally ill with no alternative therapy, while those waiting for kidneys have the potential backup of using dialysis)
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From page 30... ...
This list then reflects current allocation policies. Each type of organ has a specific matching algorithm because of differences among organs in their cold ischemic times and the requirements for improving the compatibility between the donor and the recipient.
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