© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Clin Transplant 2015: 29: 477–483 DOI: 10.1111/ctr.12550
Clinical Transplantation
Editorial
The history of trying to fix liver allocation: why a consensus approach will never work The current liver allocation system with “local” and “regional” boundaries was created based on population statistics for convenience of geography, not on prevalence of disease, location of transplant centers, or eligible donor potential. It was clear within a few years of creation of the system that where livers were needed and where they were available were different and that boundaries were helping people in some parts of the country and hurting people in others. In this edition of Clinical Transplantation, and in a publication in this journal from last fall, Rana et al. and Schwartz et al. provide compelling data highlighting the known but unresolved problem of geographic disparity in liver allocation. For example, in an intent-to-treat analysis, the mortality rate for candidates listed with a MELD score of 18 in Region 2 (31%) was more than double the mortality rate listed for candidates in Region 4 (13%) (1). Waitlisted patients with lower incomes or those receiving Medicaid were particularly disadvantaged by their lack of resources to leave Region 9 for a region with a better donor-to-recipient ratio (2). Since the inception of the legal framework for organ allocation, attempts have been made repeatedly to rewrite allocation laws in order to relieve those geographic disparities, but some with vested interests in maintaining the status quo have put up roadblocks to the enforcement of those laws. Liver transplantation is lucrative, especially in high volumes, not only financially for hospitals, but also for the careers of surgical directors or politicians with busy transplant centers in their districts. That is not to say that every doctor in favor of staying in his or her geographically privileged situation is doing so for reasons other than wanting what is best for his or her patients. Thomas Starzl, considered the father of transplantation, said: It is doubtful if many doctors who actually care for the sick and the infirm plan their actions on the basis of the predicted effect upon society. Instead, the dominant tradition is for the physician to provide the best care of which he is
capable for those who either seek his services or are assigned to his responsibility; by and large this is done without regard for the conceivably broader issue of whether treatment is justifiable on social grounds (3). Even the well-intentioned have to abide by the law. The law, after all, is there to make sure the common good is protected. In the world of liver transplantation, when the law is not upheld by those elected to uphold the law, more people die than should have died. Such is the plight of patients waiting for liver transplants in the United States. For three decades, there have been laws on the books to create fairness in the organ allocation system. Year after year, as transplant data are published by our nation’s transparent Scientific Registry of Transplant Recipients, geographic disparity is glaring. In regions with states like New York, Massachusetts, Pennsylvania, and California, waitlist deaths are higher (Table 1). Patients fortunate enough to receive liver transplants are sicker and more debilitated as reflected by higher MELD scores and longer hospital stays, affording them a lower chance of good outcomes or long-term survival. This is in distinct contrast to patients in Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, and Tennessee, where the numbers of patients on the waiting lists, compared to the number of available organs, are far more favorable—the wait time is shorter, the chance of dying on the waiting list is lower, and people are transplanted, by comparison, at relatively low MELD scores. It was not supposed to be this way. In fact, every piece of legislation written with regard to organ distribution has had the goal of eliminating disparity in organ allocation, whether that disparity be racial, economic, or geographic. As seems to occur with increasing frequency in our nation, laws that should be enforced are neglected, so that the only avenue for change is public protest or a spot in the media, where the truth may or may not prevail. In the struggle for equity in the sharing of organs,
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UNOS, United Network of Organ Sharing; OPTN, Organ Procurement and Transplantation Network; NOTA, National Organ Transplant Act; DHHS, Department of Health and Human Services; MELD, Model for EndStage Liver Disease.
Kentucky Tennessee North Carolina South Carolina Virginia Indiana Michigan Ohio New York Western Vermont Colorado Iowa Kansas Missouri Nebraska Wyoming Illinois Minnesota North Dakota South Dakota Wisconsin Alaska Hawaii Idaho Montana Oregon Washington Arizona California Nevada New Mexico Utah Oklahoma Texas Delaware District of Columbia Maryland New Jersey Pennsylvania West Virginia Northern Virginia Connecticut Maine Massachusetts New Hampshire Rhode Island Eastern Vermont
Alabama Arkansas Florida Georgia Louisiana Mississippi Puerto Rico
Region 2 Region 1
Table 1. States by UNOS region assignment
Region 3
Region 4
Region 5
Region 6
Region 7
Region 8
Region 9
Region 10
Region 11
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region is pitted against region and state against state as transplant centers in areas with longer waiting times try to maintain similar outcomes, lengths of stay, and survival as those centers that have shorter waitlists and a relatively higher percentage of donors available. Any voice pointing to the data showing organ disparity is quickly met with posturing to Congress or to the press about organ “poaching,” (4) as though anyone has ownership of organs other than the donor. To understand how organ allocation disparity could go on for so long with no change, it is important to understand how UNOS makes decisions. UNOS is governed by more than 20 committees made up of representatives from transplant centers, organ procurement organizations, histocompatibility laboratories, the public, and others from each of the 11 regions. The intent is to make sure that there is wide representation so members have the opportunity to speak to their own interests. These committees will see a need for improvement in some process, will study that process and discuss it, and then come to a consensus on a proposed resolution for the issue. These discussions are led by the Committee Chairperson, also a member of the transplant community, who can lead or sway the group as much or as little as he or she sees fit. If the scope of the discussion falls into the realm of another committee, that committee may be asked to study and discuss the topic and come to its own conclusion. Once the committees have reached a consensus, recommendations are sent to the Board, which decides if the plan put forth by the consensus is worthy of being advanced further. If so, there may be a period of public comment before voting by the various UNOS regions as to whether the suggested plan should be implemented. For the most part, this is a good system, where people who know the field can make decisions to do what is best. However, when it comes to allocation of resources, like scarce livers for transplant, the result of this governance by consensus fails, because no consensus is ever reached. When we look at the problem of geographic disparity in organ allocation, regions with more abundant supply, like Regions 3, 4, 8, 10, and 11, do not want to change the boundaries because they would lose organs. Regions 2 and 9 are begging for boundaries to be changed so they will have fewer people die on their waiting lists. Although laws have been written for the specific purpose of making organ sharing equitable, those laws have been effectively negated by the consensus governance. The purpose of this commentary is to show that consensus between haves and have-nots will never be reached until there is a bold move from UNOS or HRSA
Editorial or DHHS to hold all parties to the letter of the law. Although there have been pleas to fix the system and create geographic fairness in liver allocation policy, reliance upon the existing method of governance by consensus has failed repeatedly and will continue to fail. The laws
The legal foundation for organ allocation is the National Organ Transplant Act of 1984 (NOTA). The new Organ Procurement and Transplantation Network (OPTN) outlined in the Act was tasked with creating “equitable access by patients to organ transplantation” (Title I Sec. 101 (b) (3) (I)). Hoping to ensure that NOTA was properly instituted, Congress provided for the formation of a Task Force on Organ Transplantation for the purpose of guiding the specific functions of the OPTN. One of the directives of the Task Force was to assure “the equitable allocation of donated organs among transplant centers and among patients medically qualified for an organ transplant.” (Public Law 98–507, Sec. 101 (b) (3) (E)) In its report, published in 1986, the Task Force on Organ Transplantation recommended that “each donated organ be considered a national resource to be used for the public good.” That is, organs are to be made available for the common good of all patients, not a particular region or a particular transplant center. Seeing a need to ensure compliance with rules set forth by the OPTN, in 1986 Congress amended the Social Security Act (Omnibus Budget Reconciliation Act) requiring organ procurement organizations and hospitals to follow OPTN policies as a prerequisite for Medicare and Medicaid reimbursement. Within just two years, wording in the law needed clarification to show that patients, not transplant centers, were the focus of equitable sharing. The Organ Transplants Amendments Act of 1988 [(Title IV Omnibus Health Amendments of 1988 PL100-607) Sec 403 (a)] reinforced that priority. But the change in verbiage had no effect on the reality that livers were not being allocated equally among patients. By 1992, data were available showing that regional variation in median waiting times was substantial, ranging from 31 days in Regions 3 and 6 to 207 days in Region 9 (5). In 1993, having recognized the evolving geographic disparities in liver allocation, the University of Pittsburgh contracted with CONSAD Research Corporation to create computer simulation projections showing that broader sharing would save lives and diminish differences in waiting times. Similarly, in 1995, UNOS contracted with the Pritsker Corporation and built the first
UNOS Liver Allocation Models (ULAM). The results of these mathematical models would come to the forefront of an argument over liver allocation, an argument in front of a congressional panel, but that would not happen for a few years. The acknowledgment of geographic disparity in organ allocation continued through the mid-1990s. In 1994, the AMA addressed organ allocation in its Code of Medical Ethics. The conclusion of the AMA’s inquiry was that “organs should be considered a national, rather than a local or regional, resource. Geographic priorities in the allocation of organs should be prohibited except when transportation of organs would threaten their suitability for transplantation.” This was a call for allocation changes that was left unanswered. Also in 1994, UNOS reiterated its commitment to living up to the standards put forth in NOTA 10 years earlier in a document entitled “Statement of Principles and Objectives of Equitable Organ Allocation”(6). The goals of these objectives were to “provide transplant candidates reasonable opportunities to be considered for organ offers within comparable time periods” and “to minimize deaths while waiting for a transplant.” The same year, DHHS, realizing that OPTN goals as outlined in NOTA were not being met, issued a Notice of Proposed Rule Making (7), essentially alerting the transplant community that changes were to be made in order to fix the problem of inequitable liver sharing. The NPRM was met with objections from many transplant centers fearing a change in allocation would direct organs to the busiest transplant centers. Their objections were directed at HHS, with cries of foul that HHS would be making medical decisions regarding organs instead of the OPTN, which was run by committees of people in the medical field. In 1996, at a three-day hearing in Bethesda, Maryland, DHHS held an open forum for discussion of organ allocation policy change, including the potential for status changes among liver waitlist registrants and the possibility of broadening organ sharing to the regional, rather than local first, level. More than 100 testimonies and more than 600 letters were included in the forum. Unfortunately, the focus wandered from allocation policy and what is best for patients, to one of whether allocation decisions should be made by the government or by doctors. The end result was that several minor changes were made to organ allocation policy, mainly changes in how the various status levels were defined, but real substantive changes that would make a difference in allocation equity were never passed (8). In 1998, liver allocation was again at the forefront of HHS and Congress as the Final Rule (Title
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42, Part 121) was proposed. The Final Rule was necessary to make sure proper regulations were in place and to ensure that the national organ transplant system was functioning in accordance with NOTA. Geographic disparity, which had been flagged as a problem repeatedly in the 14 years since the passing of NOTA into law, was the focus of testimony about the Final Rule. In her address to congress in 1998, in support of broader organ allocation that would be in keeping with the law, DHHS Secretary Donna Shalala concisely stated the role of NOTA in geographic allocation fairness: The National Organ Transplant Act of 1984 requires the OPTN “to assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients. The network’s primary goal is to make sure that Americans who need an organ have an equal opportunity to receive one consistent with sound medical judgment and without regard to who they are, where they are listed, or where they live. . ...Today people are dying not because they lack health insurance, but because of where they list or where they live. . .. . .Organs should follow people, people shouldn’t follow organs” (9). The National Organ Transplant Act, in the opinion of the DHHS Secretary, was not being followed, and livers were not being shared equitably. At this same Congressional hearing, the CONSAD and Pritsker data were presented. CONSAD data estimated that, by broadening sharing, annual waitlist deaths would decrease by 8%, with a gain of 400 life years. The Pritsker model also showed improvement in waitlist death statistics, but only by 2%, an amount that falls within the possible error in the model. The American Society of Transplant Surgeons (ASTS) was not in favor of making changes to liver allocation based on the Pritsker models because there was not enough statistical difference to warrant the changes. The ASTS position was that a more moderate approach to changes in organ allocation by standardizing listing criteria and standardizing medical status definitions would “level the playing field,” perhaps making geographic disparities non-existent (9). Neither of these changes, albeit critical to the allocation process, leveled the field. The further argument by ASTS that split liver transplantation would become a major source of organs, increasing transplants by as many as 1000 per year, did not come to fruition either. To the lawmakers, the data projections were enough to say there was a problem of geographic disparity in organ allocation, what they termed “accidents of geography,” but
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they opted to leave out specific mandates of how broader sharing should be achieved (9). Nonetheless, the passage of the Final Rule was moving forward, leaving allocation policy open to the OPTN, saying that UNOS should be “distributing organs over as broad a geographic area as feasible.” However, there was no guidance for how to implement change and no suggestion of consequences if change did not happen. There was concern, however, by the most organ-privileged regions, that one step of boldness by UNOS could broaden sharing to the detriment of their centers’ high-transplant volumes. Those regions went on the defensive. Legislation was introduced to block, or at least delay, the implementation of the Final Rule. Senate Majority Leader Trent Lott of Mississippi and Senate Assistant Majority Leader Don Nickles of Oklahoma took measures to block the Final Rule by introducing legislation filed (or hidden) within other unrelated bills. The Consolidated Appropriations Act (Public Law 106–113, 1999) and the Ticket to Work and Work Incentives Act (Public Law 106–170, 1999) contained provisions that delayed the starting date of the OPTN Final Rule (8). With such legal/political maneuvers, the implementation of the Final Rule was delayed until 2000. More Congressional attempts to block the Final Rule were on the way. In the year 2000, the House of Representatives introduced bill HR2418, which would place all decision-making regarding organ allocation and distribution upon UNOS, a private entity, removing the potential oversight by the Department of Health and Human Services. The bill was sponsored by Representative Michael Bilirakis (R-Florida, UNOS Region 3). This aim of the bill was to take away the DHHS Secretary’s power to make allocation changes even if those changes were based on objective data. This bill effectively moved decision-making to the UNOS membership, which is so divided on the issue of broader sharing that it almost guaranteed no consensus would ever be reached. In a public vote, the following states overwhelmingly voted in support: Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, Mississippi, and Tennessee. New York, Massachusetts, Pennsylvania, and California voted against (8). In the Senate, there was a separate bill attempting to muddy the waters of the Final Rule. Senator Bill Frist of Tennessee (a former heart transplant surgeon) introduced S2366, which called for the creation of a board of medical experts to clarify policies on organ allocation. A team of medical experts working on the allocation problem, although it sounds like a great way to work out problems, is
Editorial inherently divided by the very “have” versus “havenot” system that exists within UNOS. In a compromise to gain support, the bill included language that would allow a greater role of the DHHS Secretary to affect UNOS policy. The bill was ultimately blocked from full vote in the Senate by Russ Feingold of Wisconsin after pressure by surgeons and transplant centers who felt the consensus system of UNOS was all that was necessary to protect the status quo, which would keep more organs in Wisconsin. Feingold also did not want the DHHS Secretary having the power to make a bold, unilateral move to push the issue of broader sharing. No agreement could be reached on either bill, and it was clear that there would be no unification of the House and Senate bills, so both were dropped (8). In another effort to block the Final Rule, the State of Louisiana (UNOS Region 3), wanting to put an end to any talk of broader sharing, went so far as to attempt to sue the DHHS Secretary (Louisiana v. Shalala, No. 98-802-C-3 m), stating that that there was no legal authority of the Secretary to put forth the Final Rule. This had the temporary effect of a stay of the Final Rule one day before it was to be put into law. Ultimately, the judge ruled that the plaintiffs lacked standing and the suit was dismissed (8). When the legal maneuvers failed and it became apparent that the Final Rule would be put into place, a number of states protected their organs by creating their own state sharing laws. Florida, South Carolina, Oklahoma, Tennessee, Wisconsin, and Louisiana enacted state laws that would either offer organs to patients in those states before offering them to patients in other states or would only offer organs to states willing to repay the organs at a later date. In Region 7, Wisconsin, Minnesota, South Dakota, and North Dakota were afraid broader sharing would lead to a large number of organs going to Chicago, a multicenter transplant metropolis. Their response was to threaten to create a new region excluding the state of Illinois unless the Chicago programs agreed to payback any livers received from their states (10). Many such sharing agreements, or alternate allocation schemes, were allowed. In 2008, however, UNOS directed the cancellation of multiple state sharing agreements, including those in Florida, Ohio, and Tennessee, but this had virtually no effect on regional geographic disparities. Minor improvements
Despite the inability to change geographic disparity, there have been provisions made to promote
fairness in liver allocation. One such change has been the implementation of the Model for EndStage Liver Disease (MELD) score, a system by which a patient’s risk of death without a transplant is measured solely by laboratory test results. The system was completely objective. Why was this needed? Prior to March 1, 2002, the date of implementation of the MELD system, a patient’s status, or position, on the waiting list could be raised merely by placing the patient in an intensive care unit. The need for intensive care was supposed to be a sign of how badly a patient needed a liver transplant, that is, the sickest patients go the ICU. But the degree of illness that would lead a doctor to put a patient in the ICU was completely subjective. Unfortunately, the subjective nature of the prior “status” system lent itself to the potential for gaming the system. Specific examples of gaming were provided in a whistle-blower case involving a large transplant center, where a surgeon testified that the center had “improperly diagnosed and hospitalized patients and exaggerated the seriousness of their medical conditions,” placing patients in the ICU to heighten their status (11). This was not an isolated practice; in fact, it was suspected that there was a widespread practice by centers to make unwarranted ICU transfers to give patients an advantage in receiving an organ. As evidence, with the adoption of the MELD score, based only on laboratory results and having no weight given to ICU status, the number of patients in ICUs at the time of transplant suddenly dropped dramatically (12). These cases are examples of a doctor’s natural inclination to save a dying patient, making it all the more understandable that a change that may take lifesaving organs away to give to another doctor’s patients may be met with strong resistance. In 2008, in a move to make organ distribution more efficient and more fair, DonorNet was introduced as the OPTN’s electronic organ offer system. DonorNet has had the intended consequence of decreasing the OPO practice of bypassing local or regional centers for an “aggressive” national center. Removal of the subjectivity of the OPO in offering organs, such that no center is bypassed in the allocation process, has meant that more organs stay local, meaning transplant centers have come to rely increasingly on their own OPO for organs. DonorNet’s impact of having more organs stay local has made allocation of organs more efficient but has magnified the problem of geographic disparity (13). The haves oppose broader liver sharing and argue to prevent UNOS’s compliance with the Final Rule. Those arguments fall into two groups: “delay tactics” and “diversionary tactics.” The best
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delay tactic is “we need more data.” The goal here is to get the nation stuck in analysis paralysis. We have years upon years of data on more than 120 000 transplanted patients in the OPTN database; how much more do we need? And how many times do we need to ignore the data that we generate? Let us look at the history. Lack of consensus conferences
The call for an end to geographic disparity in liver allocation has not died, but it is taken out every now and then to be beaten. In Atlanta in 2010, a “Consensus Conference” was held where transplant professionals convened to discuss potential liver allocation changes. A myriad of different models for allocation change were reviewed based on mathematical modeling and more than 20 years of data. Surgeons from regions with few organs made pleas for changes to the system, while surgeons from regions with more organs asked for more data, more OPO accountability, and workgroups to study allocation problems. Following the forum, a new subcommittee on Liver Utilization was created to investigate a process for expedited organ placement, as well as ways to increase utilization and reduce discards of livers. The Committee also sought further direction from Board of Directors. During the June 2010 Board of Directors meeting, the Board approved the following resolution: “RESOLVED, that the Liver and Intestinal Organ Transplantation Committee shall be charged with making recommendations to reduce geographic disparities in waitlist mortality” (14). To no one’s surprise, nothing happened as a result of this resolution to improve geographic disparity. In September 2014, a meeting similar to the Atlanta 2010 conference was to be held in Chicago. Strong data were to be presented highlighting the geographic disparity in liver allocation, and multiple new allocation models would be featured to address the issue. However, before the meeting took place, before the data were even presented, attacks against changes in allocation boundaries started. In a letter dated September 12, 2014, addressed to the administrator of the Health Resources and Services Administration, four days before the scheduled meeting, 52 members of Congress argued that the data that were going to be presented were incomplete and that the idea of broader sharing would hurt patients. Those congressmen and women were from the following states: Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, Mississippi, and Tennessee. The meeting went as scheduled and the
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data were presented. In a deja vu series of comments from the audience, the arguments of Atlanta four years earlier surfaced. One delay tactic used at the 2010 and 2014 meetings was a request for more data. Geographic disparity exists no matter how the data are viewed. A request for more data means more time, which means maintaining the status quo longer. A similar delay tactic was, “We aren’t looking at the RIGHT data.” It has been suggested that MELD AT TRANSPLANT is not a good measure of allocation disparity, despite the fact that this is exactly how organs are allocated—so that those with the highest risk of death are highest on the list. Data of waitlist deaths show the same thing—inequality across the UNOS regions. In the field of liver transplantation, there are only two outcomes: transplant or death. The data show where the sickest patients are at time of transplant and where the highest percentages of deaths are. We are looking at the right data, and we have a database of more than 120 000 patients to study. How much more data do we need? Other tactics used to prevent broader sharing are diversionary. If you take the attention off the real problem and focus it on other problems, claiming that “all problems need to be fixed at the same time,” you can again present the organ allocation system as so fraught with insurmountable obstacles that people will give up trying and keep the status quo. It was suggested in the open discussion at the Chicago meeting that before we can fix geographic disparity, we first need to change how organs are allocated to patients with hepatocellular carcinoma, we need to fix each state’s organ donor registry, and we need to fix OPO performance and prove OPOs are all equally contributing to the donor pool. These suggestions were made even though data presented at the meeting showed that variability in OPO performance was not responsible for geographic disparity. But while all of these may need attention, they have their own solutions and can be dealt with separately from the issue of geographic disparity. Finally, the idea that a solution to the problem is to move patients to the areas with organs makes no more sense now than it did 17 years ago when Donna Shalala called it a bad idea in her speech to Congress. People should not be forced to go across the country for long-term care just because we cannot obey the law to share organs fairly. Most patients do not have the means to travel or relocate, even for short periods of time. As the Mount Sinai data suggest, listing at multiple centers, socalled multilisting, does not make the system fair, it only presents more options for those with
Editorial money; patients with lower incomes or those on Medicaid had higher death rates on the waiting list because they had no financial means to leave New York to receive a transplant elsewhere (2). Multilisting does not solve geographic disparity; it highlights economic disparity. History would suggest that there will be no consensus among UNOS members to move toward compliance with the Final Rule. Compliance with the Final Rule, which must come through broader sharing, will become a reality only if it is mandated by the DHHS Secretary. Likely, that mandate would be challenged as to the authority of the Secretary to make such a mandate. I wonder how many consensus conferences we will continue to have on this same subject with the same outcome. How about we set the next one for, say, 2019? Christopher B. Hughes, MD Liver Transplantation, Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania e-mail: [email protected] Conflict of interest: None. References 1. RANA A, RIAZ IB, GRUESSNER AC, GRUESSNER RW. Geographic inequity results in disparate mortality: A multivariate intent-to-treat analysis of liver transplant data. Clin Transplant 2015: 29: 484.
2. SCHWARTZ A, SCHIANO T, KIM-SCHLUGER L, FLORMAN S. Geographic disparity: the dilemma of lower socioeconomic status, multiple listing and death on the liver transplant waiting list. Clin Transplant 2014: 28: 1075. 3. STARZL TE. Ethical problems in organ transplantation: a clinician’s point of view. Ann Intern Med 1967: 67: 32. 4. ECKERMAN K. Controversy swirls around proposed organ donor policy change. Some KC livers could be shipped to larger coastal cities. KMBC News 2014: Sept 10, 6:30pm. 5. KLASSEN AC, KLASSEN DK, BROOKMEYER R, FRANK RG, MARCONI K. Factors influencing waiting time and successful receipt of cadaveric liver transplant in the United States: 1990 to 1992. Med Care 1998: 36: 281. 6. GRAHAM W. Statement of principles and objectives of equitable organ allocation. Sem Anesth Periop Med Pain 1995: 14: 142. 7. Notice of Proposed Rulemaking (NPRM) (59 Fed. Reg. 46482), September 8, 1994 8. WEIMER DL. Public and Private Regulation of Organ Transplantation: Liver Allocation and the Final Rule. J Health Polit Policy Law 2007: 32: 9. 9. ORGAN DONATION ALLOCATION. Senate Labor and House Commerce Committees, June 18, 1998. CSPAN-2, Federal Register, 63, No. 63, April 2, 1998. 10. MARCHIONE M. Compromise reached in organ-sharing feud: Illinois agrees to “paybacks” to limit exports from Wisconsin. Milwaukee J Sentinel 1999: July 30: 1. 11. United States of America and State of Illinois ex rel. Raymond Pollak, M.D., v. Board of Trustees of the University of Illinois and the University of Chicago, 1999. 99 C 710 (N.D. Il.). 12. SNYDER J. Gaming the Liver Transplant Market. J Law Econ Organ, 2010: 26: 546. 13. GERBER DA, ARRINGTON CJ, TARANTO SE, BAKER T, SUNG RS. DonorNet and the potential effects on organ utilization. Am J Transplant 2010: 10 (4p2): 1081. 14. OPTN/UNOS Liver and Intestinal Organ Transplantation Committee Amended Report to the Board of Directors, November 8–9, 2010.
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Clin Transplant 2015: 29: 477–483 DOI: 10.1111/ctr.12550
Clinical Transplantation
Editorial
The history of trying to fix liver allocation: why a consensus approach will never work The current liver allocation system with “local” and “regional” boundaries was created based on population statistics for convenience of geography, not on prevalence of disease, location of transplant centers, or eligible donor potential. It was clear within a few years of creation of the system that where livers were needed and where they were available were different and that boundaries were helping people in some parts of the country and hurting people in others. In this edition of Clinical Transplantation, and in a publication in this journal from last fall, Rana et al. and Schwartz et al. provide compelling data highlighting the known but unresolved problem of geographic disparity in liver allocation. For example, in an intent-to-treat analysis, the mortality rate for candidates listed with a MELD score of 18 in Region 2 (31%) was more than double the mortality rate listed for candidates in Region 4 (13%) (1). Waitlisted patients with lower incomes or those receiving Medicaid were particularly disadvantaged by their lack of resources to leave Region 9 for a region with a better donor-to-recipient ratio (2). Since the inception of the legal framework for organ allocation, attempts have been made repeatedly to rewrite allocation laws in order to relieve those geographic disparities, but some with vested interests in maintaining the status quo have put up roadblocks to the enforcement of those laws. Liver transplantation is lucrative, especially in high volumes, not only financially for hospitals, but also for the careers of surgical directors or politicians with busy transplant centers in their districts. That is not to say that every doctor in favor of staying in his or her geographically privileged situation is doing so for reasons other than wanting what is best for his or her patients. Thomas Starzl, considered the father of transplantation, said: It is doubtful if many doctors who actually care for the sick and the infirm plan their actions on the basis of the predicted effect upon society. Instead, the dominant tradition is for the physician to provide the best care of which he is
capable for those who either seek his services or are assigned to his responsibility; by and large this is done without regard for the conceivably broader issue of whether treatment is justifiable on social grounds (3). Even the well-intentioned have to abide by the law. The law, after all, is there to make sure the common good is protected. In the world of liver transplantation, when the law is not upheld by those elected to uphold the law, more people die than should have died. Such is the plight of patients waiting for liver transplants in the United States. For three decades, there have been laws on the books to create fairness in the organ allocation system. Year after year, as transplant data are published by our nation’s transparent Scientific Registry of Transplant Recipients, geographic disparity is glaring. In regions with states like New York, Massachusetts, Pennsylvania, and California, waitlist deaths are higher (Table 1). Patients fortunate enough to receive liver transplants are sicker and more debilitated as reflected by higher MELD scores and longer hospital stays, affording them a lower chance of good outcomes or long-term survival. This is in distinct contrast to patients in Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, and Tennessee, where the numbers of patients on the waiting lists, compared to the number of available organs, are far more favorable—the wait time is shorter, the chance of dying on the waiting list is lower, and people are transplanted, by comparison, at relatively low MELD scores. It was not supposed to be this way. In fact, every piece of legislation written with regard to organ distribution has had the goal of eliminating disparity in organ allocation, whether that disparity be racial, economic, or geographic. As seems to occur with increasing frequency in our nation, laws that should be enforced are neglected, so that the only avenue for change is public protest or a spot in the media, where the truth may or may not prevail. In the struggle for equity in the sharing of organs,
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UNOS, United Network of Organ Sharing; OPTN, Organ Procurement and Transplantation Network; NOTA, National Organ Transplant Act; DHHS, Department of Health and Human Services; MELD, Model for EndStage Liver Disease.
Kentucky Tennessee North Carolina South Carolina Virginia Indiana Michigan Ohio New York Western Vermont Colorado Iowa Kansas Missouri Nebraska Wyoming Illinois Minnesota North Dakota South Dakota Wisconsin Alaska Hawaii Idaho Montana Oregon Washington Arizona California Nevada New Mexico Utah Oklahoma Texas Delaware District of Columbia Maryland New Jersey Pennsylvania West Virginia Northern Virginia Connecticut Maine Massachusetts New Hampshire Rhode Island Eastern Vermont
Alabama Arkansas Florida Georgia Louisiana Mississippi Puerto Rico
Region 2 Region 1
Table 1. States by UNOS region assignment
Region 3
Region 4
Region 5
Region 6
Region 7
Region 8
Region 9
Region 10
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region is pitted against region and state against state as transplant centers in areas with longer waiting times try to maintain similar outcomes, lengths of stay, and survival as those centers that have shorter waitlists and a relatively higher percentage of donors available. Any voice pointing to the data showing organ disparity is quickly met with posturing to Congress or to the press about organ “poaching,” (4) as though anyone has ownership of organs other than the donor. To understand how organ allocation disparity could go on for so long with no change, it is important to understand how UNOS makes decisions. UNOS is governed by more than 20 committees made up of representatives from transplant centers, organ procurement organizations, histocompatibility laboratories, the public, and others from each of the 11 regions. The intent is to make sure that there is wide representation so members have the opportunity to speak to their own interests. These committees will see a need for improvement in some process, will study that process and discuss it, and then come to a consensus on a proposed resolution for the issue. These discussions are led by the Committee Chairperson, also a member of the transplant community, who can lead or sway the group as much or as little as he or she sees fit. If the scope of the discussion falls into the realm of another committee, that committee may be asked to study and discuss the topic and come to its own conclusion. Once the committees have reached a consensus, recommendations are sent to the Board, which decides if the plan put forth by the consensus is worthy of being advanced further. If so, there may be a period of public comment before voting by the various UNOS regions as to whether the suggested plan should be implemented. For the most part, this is a good system, where people who know the field can make decisions to do what is best. However, when it comes to allocation of resources, like scarce livers for transplant, the result of this governance by consensus fails, because no consensus is ever reached. When we look at the problem of geographic disparity in organ allocation, regions with more abundant supply, like Regions 3, 4, 8, 10, and 11, do not want to change the boundaries because they would lose organs. Regions 2 and 9 are begging for boundaries to be changed so they will have fewer people die on their waiting lists. Although laws have been written for the specific purpose of making organ sharing equitable, those laws have been effectively negated by the consensus governance. The purpose of this commentary is to show that consensus between haves and have-nots will never be reached until there is a bold move from UNOS or HRSA
Editorial or DHHS to hold all parties to the letter of the law. Although there have been pleas to fix the system and create geographic fairness in liver allocation policy, reliance upon the existing method of governance by consensus has failed repeatedly and will continue to fail. The laws
The legal foundation for organ allocation is the National Organ Transplant Act of 1984 (NOTA). The new Organ Procurement and Transplantation Network (OPTN) outlined in the Act was tasked with creating “equitable access by patients to organ transplantation” (Title I Sec. 101 (b) (3) (I)). Hoping to ensure that NOTA was properly instituted, Congress provided for the formation of a Task Force on Organ Transplantation for the purpose of guiding the specific functions of the OPTN. One of the directives of the Task Force was to assure “the equitable allocation of donated organs among transplant centers and among patients medically qualified for an organ transplant.” (Public Law 98–507, Sec. 101 (b) (3) (E)) In its report, published in 1986, the Task Force on Organ Transplantation recommended that “each donated organ be considered a national resource to be used for the public good.” That is, organs are to be made available for the common good of all patients, not a particular region or a particular transplant center. Seeing a need to ensure compliance with rules set forth by the OPTN, in 1986 Congress amended the Social Security Act (Omnibus Budget Reconciliation Act) requiring organ procurement organizations and hospitals to follow OPTN policies as a prerequisite for Medicare and Medicaid reimbursement. Within just two years, wording in the law needed clarification to show that patients, not transplant centers, were the focus of equitable sharing. The Organ Transplants Amendments Act of 1988 [(Title IV Omnibus Health Amendments of 1988 PL100-607) Sec 403 (a)] reinforced that priority. But the change in verbiage had no effect on the reality that livers were not being allocated equally among patients. By 1992, data were available showing that regional variation in median waiting times was substantial, ranging from 31 days in Regions 3 and 6 to 207 days in Region 9 (5). In 1993, having recognized the evolving geographic disparities in liver allocation, the University of Pittsburgh contracted with CONSAD Research Corporation to create computer simulation projections showing that broader sharing would save lives and diminish differences in waiting times. Similarly, in 1995, UNOS contracted with the Pritsker Corporation and built the first
UNOS Liver Allocation Models (ULAM). The results of these mathematical models would come to the forefront of an argument over liver allocation, an argument in front of a congressional panel, but that would not happen for a few years. The acknowledgment of geographic disparity in organ allocation continued through the mid-1990s. In 1994, the AMA addressed organ allocation in its Code of Medical Ethics. The conclusion of the AMA’s inquiry was that “organs should be considered a national, rather than a local or regional, resource. Geographic priorities in the allocation of organs should be prohibited except when transportation of organs would threaten their suitability for transplantation.” This was a call for allocation changes that was left unanswered. Also in 1994, UNOS reiterated its commitment to living up to the standards put forth in NOTA 10 years earlier in a document entitled “Statement of Principles and Objectives of Equitable Organ Allocation”(6). The goals of these objectives were to “provide transplant candidates reasonable opportunities to be considered for organ offers within comparable time periods” and “to minimize deaths while waiting for a transplant.” The same year, DHHS, realizing that OPTN goals as outlined in NOTA were not being met, issued a Notice of Proposed Rule Making (7), essentially alerting the transplant community that changes were to be made in order to fix the problem of inequitable liver sharing. The NPRM was met with objections from many transplant centers fearing a change in allocation would direct organs to the busiest transplant centers. Their objections were directed at HHS, with cries of foul that HHS would be making medical decisions regarding organs instead of the OPTN, which was run by committees of people in the medical field. In 1996, at a three-day hearing in Bethesda, Maryland, DHHS held an open forum for discussion of organ allocation policy change, including the potential for status changes among liver waitlist registrants and the possibility of broadening organ sharing to the regional, rather than local first, level. More than 100 testimonies and more than 600 letters were included in the forum. Unfortunately, the focus wandered from allocation policy and what is best for patients, to one of whether allocation decisions should be made by the government or by doctors. The end result was that several minor changes were made to organ allocation policy, mainly changes in how the various status levels were defined, but real substantive changes that would make a difference in allocation equity were never passed (8). In 1998, liver allocation was again at the forefront of HHS and Congress as the Final Rule (Title
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42, Part 121) was proposed. The Final Rule was necessary to make sure proper regulations were in place and to ensure that the national organ transplant system was functioning in accordance with NOTA. Geographic disparity, which had been flagged as a problem repeatedly in the 14 years since the passing of NOTA into law, was the focus of testimony about the Final Rule. In her address to congress in 1998, in support of broader organ allocation that would be in keeping with the law, DHHS Secretary Donna Shalala concisely stated the role of NOTA in geographic allocation fairness: The National Organ Transplant Act of 1984 requires the OPTN “to assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients. The network’s primary goal is to make sure that Americans who need an organ have an equal opportunity to receive one consistent with sound medical judgment and without regard to who they are, where they are listed, or where they live. . ...Today people are dying not because they lack health insurance, but because of where they list or where they live. . .. . .Organs should follow people, people shouldn’t follow organs” (9). The National Organ Transplant Act, in the opinion of the DHHS Secretary, was not being followed, and livers were not being shared equitably. At this same Congressional hearing, the CONSAD and Pritsker data were presented. CONSAD data estimated that, by broadening sharing, annual waitlist deaths would decrease by 8%, with a gain of 400 life years. The Pritsker model also showed improvement in waitlist death statistics, but only by 2%, an amount that falls within the possible error in the model. The American Society of Transplant Surgeons (ASTS) was not in favor of making changes to liver allocation based on the Pritsker models because there was not enough statistical difference to warrant the changes. The ASTS position was that a more moderate approach to changes in organ allocation by standardizing listing criteria and standardizing medical status definitions would “level the playing field,” perhaps making geographic disparities non-existent (9). Neither of these changes, albeit critical to the allocation process, leveled the field. The further argument by ASTS that split liver transplantation would become a major source of organs, increasing transplants by as many as 1000 per year, did not come to fruition either. To the lawmakers, the data projections were enough to say there was a problem of geographic disparity in organ allocation, what they termed “accidents of geography,” but
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they opted to leave out specific mandates of how broader sharing should be achieved (9). Nonetheless, the passage of the Final Rule was moving forward, leaving allocation policy open to the OPTN, saying that UNOS should be “distributing organs over as broad a geographic area as feasible.” However, there was no guidance for how to implement change and no suggestion of consequences if change did not happen. There was concern, however, by the most organ-privileged regions, that one step of boldness by UNOS could broaden sharing to the detriment of their centers’ high-transplant volumes. Those regions went on the defensive. Legislation was introduced to block, or at least delay, the implementation of the Final Rule. Senate Majority Leader Trent Lott of Mississippi and Senate Assistant Majority Leader Don Nickles of Oklahoma took measures to block the Final Rule by introducing legislation filed (or hidden) within other unrelated bills. The Consolidated Appropriations Act (Public Law 106–113, 1999) and the Ticket to Work and Work Incentives Act (Public Law 106–170, 1999) contained provisions that delayed the starting date of the OPTN Final Rule (8). With such legal/political maneuvers, the implementation of the Final Rule was delayed until 2000. More Congressional attempts to block the Final Rule were on the way. In the year 2000, the House of Representatives introduced bill HR2418, which would place all decision-making regarding organ allocation and distribution upon UNOS, a private entity, removing the potential oversight by the Department of Health and Human Services. The bill was sponsored by Representative Michael Bilirakis (R-Florida, UNOS Region 3). This aim of the bill was to take away the DHHS Secretary’s power to make allocation changes even if those changes were based on objective data. This bill effectively moved decision-making to the UNOS membership, which is so divided on the issue of broader sharing that it almost guaranteed no consensus would ever be reached. In a public vote, the following states overwhelmingly voted in support: Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, Mississippi, and Tennessee. New York, Massachusetts, Pennsylvania, and California voted against (8). In the Senate, there was a separate bill attempting to muddy the waters of the Final Rule. Senator Bill Frist of Tennessee (a former heart transplant surgeon) introduced S2366, which called for the creation of a board of medical experts to clarify policies on organ allocation. A team of medical experts working on the allocation problem, although it sounds like a great way to work out problems, is
Editorial inherently divided by the very “have” versus “havenot” system that exists within UNOS. In a compromise to gain support, the bill included language that would allow a greater role of the DHHS Secretary to affect UNOS policy. The bill was ultimately blocked from full vote in the Senate by Russ Feingold of Wisconsin after pressure by surgeons and transplant centers who felt the consensus system of UNOS was all that was necessary to protect the status quo, which would keep more organs in Wisconsin. Feingold also did not want the DHHS Secretary having the power to make a bold, unilateral move to push the issue of broader sharing. No agreement could be reached on either bill, and it was clear that there would be no unification of the House and Senate bills, so both were dropped (8). In another effort to block the Final Rule, the State of Louisiana (UNOS Region 3), wanting to put an end to any talk of broader sharing, went so far as to attempt to sue the DHHS Secretary (Louisiana v. Shalala, No. 98-802-C-3 m), stating that that there was no legal authority of the Secretary to put forth the Final Rule. This had the temporary effect of a stay of the Final Rule one day before it was to be put into law. Ultimately, the judge ruled that the plaintiffs lacked standing and the suit was dismissed (8). When the legal maneuvers failed and it became apparent that the Final Rule would be put into place, a number of states protected their organs by creating their own state sharing laws. Florida, South Carolina, Oklahoma, Tennessee, Wisconsin, and Louisiana enacted state laws that would either offer organs to patients in those states before offering them to patients in other states or would only offer organs to states willing to repay the organs at a later date. In Region 7, Wisconsin, Minnesota, South Dakota, and North Dakota were afraid broader sharing would lead to a large number of organs going to Chicago, a multicenter transplant metropolis. Their response was to threaten to create a new region excluding the state of Illinois unless the Chicago programs agreed to payback any livers received from their states (10). Many such sharing agreements, or alternate allocation schemes, were allowed. In 2008, however, UNOS directed the cancellation of multiple state sharing agreements, including those in Florida, Ohio, and Tennessee, but this had virtually no effect on regional geographic disparities. Minor improvements
Despite the inability to change geographic disparity, there have been provisions made to promote
fairness in liver allocation. One such change has been the implementation of the Model for EndStage Liver Disease (MELD) score, a system by which a patient’s risk of death without a transplant is measured solely by laboratory test results. The system was completely objective. Why was this needed? Prior to March 1, 2002, the date of implementation of the MELD system, a patient’s status, or position, on the waiting list could be raised merely by placing the patient in an intensive care unit. The need for intensive care was supposed to be a sign of how badly a patient needed a liver transplant, that is, the sickest patients go the ICU. But the degree of illness that would lead a doctor to put a patient in the ICU was completely subjective. Unfortunately, the subjective nature of the prior “status” system lent itself to the potential for gaming the system. Specific examples of gaming were provided in a whistle-blower case involving a large transplant center, where a surgeon testified that the center had “improperly diagnosed and hospitalized patients and exaggerated the seriousness of their medical conditions,” placing patients in the ICU to heighten their status (11). This was not an isolated practice; in fact, it was suspected that there was a widespread practice by centers to make unwarranted ICU transfers to give patients an advantage in receiving an organ. As evidence, with the adoption of the MELD score, based only on laboratory results and having no weight given to ICU status, the number of patients in ICUs at the time of transplant suddenly dropped dramatically (12). These cases are examples of a doctor’s natural inclination to save a dying patient, making it all the more understandable that a change that may take lifesaving organs away to give to another doctor’s patients may be met with strong resistance. In 2008, in a move to make organ distribution more efficient and more fair, DonorNet was introduced as the OPTN’s electronic organ offer system. DonorNet has had the intended consequence of decreasing the OPO practice of bypassing local or regional centers for an “aggressive” national center. Removal of the subjectivity of the OPO in offering organs, such that no center is bypassed in the allocation process, has meant that more organs stay local, meaning transplant centers have come to rely increasingly on their own OPO for organs. DonorNet’s impact of having more organs stay local has made allocation of organs more efficient but has magnified the problem of geographic disparity (13). The haves oppose broader liver sharing and argue to prevent UNOS’s compliance with the Final Rule. Those arguments fall into two groups: “delay tactics” and “diversionary tactics.” The best
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delay tactic is “we need more data.” The goal here is to get the nation stuck in analysis paralysis. We have years upon years of data on more than 120 000 transplanted patients in the OPTN database; how much more do we need? And how many times do we need to ignore the data that we generate? Let us look at the history. Lack of consensus conferences
The call for an end to geographic disparity in liver allocation has not died, but it is taken out every now and then to be beaten. In Atlanta in 2010, a “Consensus Conference” was held where transplant professionals convened to discuss potential liver allocation changes. A myriad of different models for allocation change were reviewed based on mathematical modeling and more than 20 years of data. Surgeons from regions with few organs made pleas for changes to the system, while surgeons from regions with more organs asked for more data, more OPO accountability, and workgroups to study allocation problems. Following the forum, a new subcommittee on Liver Utilization was created to investigate a process for expedited organ placement, as well as ways to increase utilization and reduce discards of livers. The Committee also sought further direction from Board of Directors. During the June 2010 Board of Directors meeting, the Board approved the following resolution: “RESOLVED, that the Liver and Intestinal Organ Transplantation Committee shall be charged with making recommendations to reduce geographic disparities in waitlist mortality” (14). To no one’s surprise, nothing happened as a result of this resolution to improve geographic disparity. In September 2014, a meeting similar to the Atlanta 2010 conference was to be held in Chicago. Strong data were to be presented highlighting the geographic disparity in liver allocation, and multiple new allocation models would be featured to address the issue. However, before the meeting took place, before the data were even presented, attacks against changes in allocation boundaries started. In a letter dated September 12, 2014, addressed to the administrator of the Health Resources and Services Administration, four days before the scheduled meeting, 52 members of Congress argued that the data that were going to be presented were incomplete and that the idea of broader sharing would hurt patients. Those congressmen and women were from the following states: Georgia, Florida, Kansas, Indiana, Ohio, Texas, Missouri, Iowa, Alabama, Mississippi, and Tennessee. The meeting went as scheduled and the
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data were presented. In a deja vu series of comments from the audience, the arguments of Atlanta four years earlier surfaced. One delay tactic used at the 2010 and 2014 meetings was a request for more data. Geographic disparity exists no matter how the data are viewed. A request for more data means more time, which means maintaining the status quo longer. A similar delay tactic was, “We aren’t looking at the RIGHT data.” It has been suggested that MELD AT TRANSPLANT is not a good measure of allocation disparity, despite the fact that this is exactly how organs are allocated—so that those with the highest risk of death are highest on the list. Data of waitlist deaths show the same thing—inequality across the UNOS regions. In the field of liver transplantation, there are only two outcomes: transplant or death. The data show where the sickest patients are at time of transplant and where the highest percentages of deaths are. We are looking at the right data, and we have a database of more than 120 000 patients to study. How much more data do we need? Other tactics used to prevent broader sharing are diversionary. If you take the attention off the real problem and focus it on other problems, claiming that “all problems need to be fixed at the same time,” you can again present the organ allocation system as so fraught with insurmountable obstacles that people will give up trying and keep the status quo. It was suggested in the open discussion at the Chicago meeting that before we can fix geographic disparity, we first need to change how organs are allocated to patients with hepatocellular carcinoma, we need to fix each state’s organ donor registry, and we need to fix OPO performance and prove OPOs are all equally contributing to the donor pool. These suggestions were made even though data presented at the meeting showed that variability in OPO performance was not responsible for geographic disparity. But while all of these may need attention, they have their own solutions and can be dealt with separately from the issue of geographic disparity. Finally, the idea that a solution to the problem is to move patients to the areas with organs makes no more sense now than it did 17 years ago when Donna Shalala called it a bad idea in her speech to Congress. People should not be forced to go across the country for long-term care just because we cannot obey the law to share organs fairly. Most patients do not have the means to travel or relocate, even for short periods of time. As the Mount Sinai data suggest, listing at multiple centers, socalled multilisting, does not make the system fair, it only presents more options for those with
Editorial money; patients with lower incomes or those on Medicaid had higher death rates on the waiting list because they had no financial means to leave New York to receive a transplant elsewhere (2). Multilisting does not solve geographic disparity; it highlights economic disparity. History would suggest that there will be no consensus among UNOS members to move toward compliance with the Final Rule. Compliance with the Final Rule, which must come through broader sharing, will become a reality only if it is mandated by the DHHS Secretary. Likely, that mandate would be challenged as to the authority of the Secretary to make such a mandate. I wonder how many consensus conferences we will continue to have on this same subject with the same outcome. How about we set the next one for, say, 2019? Christopher B. Hughes, MD Liver Transplantation, Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania e-mail: [email protected] Conflict of interest: None. References 1. RANA A, RIAZ IB, GRUESSNER AC, GRUESSNER RW. Geographic inequity results in disparate mortality: A multivariate intent-to-treat analysis of liver transplant data. Clin Transplant 2015: 29: 484.
2. SCHWARTZ A, SCHIANO T, KIM-SCHLUGER L, FLORMAN S. Geographic disparity: the dilemma of lower socioeconomic status, multiple listing and death on the liver transplant waiting list. Clin Transplant 2014: 28: 1075. 3. STARZL TE. Ethical problems in organ transplantation: a clinician’s point of view. Ann Intern Med 1967: 67: 32. 4. ECKERMAN K. Controversy swirls around proposed organ donor policy change. Some KC livers could be shipped to larger coastal cities. KMBC News 2014: Sept 10, 6:30pm. 5. KLASSEN AC, KLASSEN DK, BROOKMEYER R, FRANK RG, MARCONI K. Factors influencing waiting time and successful receipt of cadaveric liver transplant in the United States: 1990 to 1992. Med Care 1998: 36: 281. 6. GRAHAM W. Statement of principles and objectives of equitable organ allocation. Sem Anesth Periop Med Pain 1995: 14: 142. 7. Notice of Proposed Rulemaking (NPRM) (59 Fed. Reg. 46482), September 8, 1994 8. WEIMER DL. Public and Private Regulation of Organ Transplantation: Liver Allocation and the Final Rule. J Health Polit Policy Law 2007: 32: 9. 9. ORGAN DONATION ALLOCATION. Senate Labor and House Commerce Committees, June 18, 1998. CSPAN-2, Federal Register, 63, No. 63, April 2, 1998. 10. MARCHIONE M. Compromise reached in organ-sharing feud: Illinois agrees to “paybacks” to limit exports from Wisconsin. Milwaukee J Sentinel 1999: July 30: 1. 11. United States of America and State of Illinois ex rel. Raymond Pollak, M.D., v. Board of Trustees of the University of Illinois and the University of Chicago, 1999. 99 C 710 (N.D. Il.). 12. SNYDER J. Gaming the Liver Transplant Market. J Law Econ Organ, 2010: 26: 546. 13. GERBER DA, ARRINGTON CJ, TARANTO SE, BAKER T, SUNG RS. DonorNet and the potential effects on organ utilization. Am J Transplant 2010: 10 (4p2): 1081. 14. OPTN/UNOS Liver and Intestinal Organ Transplantation Committee Amended Report to the Board of Directors, November 8–9, 2010.
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