February 1999 By Tom Koch Editor's note: The allocation of transplantable organs has been the subject of considerable public debate throughout the transplant community during the past year. The debate reached Congress in 1998, and the issue remains far from settled. In the August 1998 issue of OR/MS Today, A. Alan B. Pritsker provided an overview of the model that was developed on behalf of UNOS to compare proposed alternatives for national liver allocation policies. In this article, Tom Koch focuses on the general issues of fairness in the allocation of life-saving organs, using hearts as an example. While the two articles present very different pictures of the same subject, both demonstrate the value of operations research in the search for solutions to a complex and critical public policy problem. At first glance, a recent dispute between the U.S. Department of Health and Human Services (HHS) and the United Network for Organ Sharing (UNOS) seems like just another squabble between a federal agency and its client agency. In simple terms, HHS told Congress it wasn't happy with the performance of the nation's organ transplant program, administered by UNOS, and that federal rules would be changed to improve the system. UNOS argued strongly that its policies were the best possible and that HHS should butt out. In many ways, the debate between these two organizations is a textbook example of a dispute between a regionally focused administrative department and the national organization that it purportedly answers to. This is not, however, just another OR/MS problem. It involves the lives of extremely ill persons. Because the demand for graft organs far outstrips supply — there are at present less than 20,000 organs available for the more than 60,000 persons currently awaiting transplantation — methods of allocation are critical. If one seeks to save as many of those lives as possible, organs must be allocated in an efficient and timely fashion. And because donation is voluntary, potential donors must perceive the system as fair, inclusive and equitable. If it is not, donation rates (and thus organ supply) will suffer. [1] The goal, therefore, is a policy that allocates organs efficiently, equitably and in a way that maximizes the potential supply of organs. Identifying system barriers that may impede these goals — fair distribution and maximizing supply — is a necessary first step in the analysis The Dispute In a February 1998 letter to the U.S. Congress, U.S. Health and Human Services Secretary Donna Shalala announced her department would order changes in the national Organ Procurement and Transplantation Network (OPTN) administered by UNOS because, "we have not achieved equitable distribution to those with greatest medical need." [2] Specific problems included the fact that, "In some areas of our nation, patients wait five times longer or more for an organ than in other areas ... in the worst case, patients die in areas where waiting times are long while at the same time organs are being made available to less ill patients in areas with shorter waiting times." On April 2, 1998, HHS published new regulations in the Federal Register. Included were these goals: "Organs should be equitably allocated to all patients," and that, "Transplant patients are best served by an allocation system that functions equitably on a nationwide basis" [3] UNOS reacted strongly to the HHS initiative, arguing against the national perspective. In March 1998 its executive director issued a letter to UNOS members urging them to condemn the proposed HHS regulations in meetings with members' legislative representatives. It defended its regionally based program, but in June 1998 UNOS President Dr. Larry Hunsicker admitted that, "We have general principles but we don't yet know how we as a community want to measure the question of fairness." What is fair and equitable, and importantly, how do those criteria affect transplantation? Objectives The dispute between HHS and UNOS is a matter of means, not ends. Reading HHS and UNOS documents reveals a commonality of objectives (see Figure 1). Three of four stated goals are clearly shared by both bureaucracies: Survival (of both patients and graft organs). Both HHS and UNOS seek the greatest survival rate for patients and for organs used in transplantation. Equality (nationally, across regions, and in the treatment of individual patients). The question is, how to achieve equality at these different levels? Increased organ donation. General arguments for donation are beneficence and altruism, "local pride" in successful regional transplant centers; and ideally, knowing someone who has survived because of a transplant (neighbor-effect). Decreasing costs. This is an objective of both bureaucracies. It includes limiting cost to providers and patients. Figure 1 These objectives are mutually related at the operational level. Increased organ donation would permit more frequent procedures, allowing participating hospitals to better recuperate overhead costs. Increased donation — a better supply — would reduce system pressures and thus inequities caused by scarcity. Decreasing costs would encourage system participation by hospitals who might be unable at present to afford a transplant program. They also would decrease the burden on patients and insurers for whom transplantation and post-transplant care is today financially onerous or prohibitive. In theory, this would increase donation through the neighbor effect by increasing numbers of potential donors known both to recipients and families of persons who were local donors. At the third level of the model are criteria affecting these goals. They include "eligibility," who gets on the organ transplant waiting list; "mean waiting time," the generally accepted measure for regional equity; and "distance/travel," the spatial problem of matching organs and patients where one or the other must travel. Even this necessarily brief overview of relations between these objectives reveals what Lynton K. Caldwell calls "conceptual parallax errors" in which relatively slight and apparently inconsequential differences in viewpoint create very different perspectives on an organizational problem. [4] By pointing out these distortions — if they are errors they are ones made in good faith — the hope is that a better system will result. Equality At the level of the medically needy patient, inequalities are inherent in the system. "Although the procurement system is national, patients' access to it is not. Patients must generally either have health insurance that will pay for a transplantation or [must] be able to pay for it themselves." [5] Further, some insurers have arrangements with specific transplant centers to serve as transplant providers. Their clients may have to travel to a distant hospital rather than use a closer facility because that's what their provider requires. This adds to patient or insurer expense while diminishing any "neighbor-effect" that might increase donations locally. Inequalities based on economics — the ability to purchase appropriate health insurance — is also a matter of race and class. As a general rule, those with lower education, lower incomes — and thus without health insurance — are more often members of non-Caucasian ethnic groups. One recent federal study demonstrated that about 30 percent of U.S. Hispanics were found to be uninsured, for example. They thus would be ineligible for transplantation support. [6] Exclusion from the system is a form of inequity. It may also explain low organ donation rates in major cities. A recent Associated Press survey of organ donation rates revealed lower rates in cities with ethnically diverse, non-Caucasian populations (New York City, Jackson, Miss., Puerto Rico, etc.).[7] "Low-performing (organ) banks point almost uniformly to ethnic groups wary of donation: African Americans in Georgia and New York City, Mexican Americans in south Texas; Filipinos in Hawaii, Native Americans in the Northwest." Why should people in these communities donate, however? After all, race and socioeconomic status adversely influence the likelihood individuals will be placed on a transplant waiting list.[8] Ethnic Americans generally have lower incomes than the greater population and are thus less likely to have health insurance. They thus are less likely to be organ recipients. If they become organ donors, their beneficence is less likely to help persons in their own community. [9] Not only does this affect the goal of equality among medically needy patients, it almost certainly has an impact on organ supply. Why should people with little likelihood of access contribute to the system? If neither they nor their neighbors are likely to be organ recipients, why should persons in these communities become organ donors? Regional Issues For purposes of administration and allocation, the United States is divided into 11 distinct regions (see Figure 2) with populations ranging from approximately 13.3 million inhabitants (Region 6) to 42.8 million persons (Region 5). Alaska is a member of Region 6 (the Pacific Northwest) while Hawaii is a member of Region 5 (Pacific Region). In 1997, there were 277 transplant centers served by 69 organ procurement organizations (OPOs) within the 11-region UNOS system. [10] Typically located in or near a transplant-performing hospital, OPOs offer services in organ donor referral, evaluation and surgical recovery, services for which they then bill participating hospitals. Figure 2 Organ allocation is a complex process involving medical compatibility between organ donor and recipient, social judgments (who should be qualified as a recipient?) and issues of spatial distribution. In this article, the latter is the focus. Those interested in a broader review of social criteria are referred to my recent book, "The Limits of Principle."[11] Allocation in the regional system is weighted for geographic proximity. That is, the system advantages potential recipients who are registered at or near a donor hospital over those who may live at a greater distance from the donor facility. For example, a heart available for use in Los Angeles might first be offered to patients registered at the local OPO, and then to those registered at a Pacific Region transplant center within a 500-mile radius of the L.A. hospital. If no match occurs, the system is expanded outward to a greater radius, to other proximate regions, and then nationally to anyone who can recover the heart within the graft organ's four- to five-hour frame of viability. This means that utilization of a graft organ will not necessarily be shared by geographically proximate cities — for example Newark, N.J. and New York City — separated by a UNOS-generated regional border. As a 1996 Forbes magazine article critical of current policies concluded, "a critically ill patient in one city might die while organs go to less desperate patients nearby. The system was supposed to ensure the supply and fair allocation of organs. It doesn't work that easily." Minimizing regional disparities is a stated goal of both UNOS [11] and HHS. Typically, regional disparities are measured by mean waiting time (MWT). These are reported, organ by organ, within each administrative region. Because different organs require different types of matches — kidneys require a specific antigen compatibility, hearts must be matched between donors and recipients of generally equal size — waiting times can't be aggregated for all organs. For the purposes of illustration, consider the MWT for hearts in 1996. UNOS data describes MWT for persons entering the system with failing hearts in a state of extreme medical urgency (Category 1) who are transplanted more or less quickly. Secondarily, they list persons entering in a debilitated but not extreme stage of urgency (Category 2) who are transplanted when they reach Category 1 of medical urgency. Figure 2 maps mean waiting times by region for people entering the transplant waiting list in 1996 at Category 2 of urgency who were transplanted when their condition is Category 1. The issue is not merely the mean waiting time of a single recipient in a region, however, but the number of people waiting and the number of days they had to wait for an organ. Thus for this map MWT was calculated by multiplying the number of people waiting for a transplant in a region by the mean number of days waiting. Using this measure, regional disparities occur at an order of 10 or greater between those regions with the fewest number of patients waiting the least number of days (Region 6, Region 1) and those with the largest number of persons waiting the greatest number of days (Region 2). Regions: By State The reasons for these disparities can be found, in part, in the location of transplant-performing hospitals represented on the map by red circles. Consider, for example, Region 1 (New England) and Region 6 (Central Pacific). New England (excepting Connecticut) is Massachusetts. Indeed, Region 1 is essentially Boston. Residents of other regional states may list in Boston, or in other, more distant centers (Newark, N.J., New York, etc.). Since they must travel from their homes to a distant hospital or transplant site, there is no compulsion for them to choose the closest transplant center. Indeed, since the system permits multiple listing, a person in Bangor, Maine, would be wise to register as a potential heart recipient in Boston and New York City and Pittsburgh. For Bostonians, this means an already small service population is, in fact, far smaller than it appears since other New Englanders may choose to register in Region 9 or Region 2 hospitals. Of course, this also means that most New Englanders living outside Eastern Massachusetts have little incentive to become organ donors. They have no "neighborhood effect" to stimulate participation in donation programs. If they know someone who has had a transplant, that operation was as likely performed out of state and very probably in another transplant region entirely. If an organ is donated in, say, Bangor, Maine, the lack of a local, participating hospital means the organ must be sent elsewhere (Boston; Albany, N.Y.; Newark, N.J.; New York City). That adds travel time to the system, a fact that diminishes the likelihood the organ will find a recipient within the heart's short period of viability (four to five hours). Thus the likelihood of its finding an appropriate host is diminished. Again, supply is affected: Local donors are not encouraged and distanced organs must travel longer to find a recipient. Similarly, the boundaries of Region 6 (the Pacific Northwest) are deceptive. It includes the population of a number of states — Montana, Idaho and Alaska — without any participating hospitals or transplant service. Persons living in those states are as likely to register for transplants in Region 5, Region 7, Region 10 — or in all of them together — as they are with services in Seattle, Portland, or Tacoma, Wash. Thus the region's service population is diminished, as is any neighborhood effect for many of the region's perspective donors. Persons here are isolated in another fashion, however. Because hearts which cannot be used by a local hospital are first offered within a region to geographically proximate hospitals, the potential for sharing in Region 6 is minimal when compared to other areas. Seattle's initial 500-mile radius includes only the Portland and Spokane centers. Spokane's circle for first-call on organs includes only Seattle. The region is effectively isolated when compared to, say, California. From the San Francisco Bay area to San Diego there are 14 hospitals offering heart transplant services within a 500-mile radius. A heart available at, say, Stanford Medical Center in Palo Alto, Calif., is more likely to find an acceptable donor in its area. California becomes, in the words of one transplant coordinator, a "black hole" into which organs flow but from which few emerge to assist other centers. The Pacific Region's seemingly large population — 42.8 million — should assure a supply of hearts. But the region includes Hawaii, whose citizens are too distant to be likely heart donors. Travel from Hawaii to California takes too long. Regionalization does not effectively serve distant participants. As importantly, the Pacific Region's population includes a large percentage of ethnic citizens who are statistically less likely to be donors. They lack health insurance and therefore are unlikely to be recipients. According to one recent federal study, for example, 34 percent of the U.S. Hispanic population under 65 years of age does not have health insurance. Nor do they have sufficient income to self-finance a transplant. The number of uninsured is far higher for Hispanic-Americans aged 18-25 years. But then, this age group is generally less likely to have health insurance than other age groups (see Figure 3). More generally excluded as potential recipients, only the greatest of altruism would convince these uninsured citizens to be organ donors. Figure 3 A similar if less dramatic exclusion is found among African-Americans who while more likely to have health insurance than Hispanic citizens, are still less likely to be insured than Caucasian citizens. Further, as others have noted, the history of racial discrimination in U.S. medicine has made many wary of "altruism" in their relations with others, and dubious about the potential for equality. It is not surprising, therefore, that African-Americans are more rarely donors than their Caucasian neighbors. This adversely affects donation rates in cities like New York and Jackson, Miss. Results The result is a system that promises but fails to deliver comprehensive national coverage. Figure 4 presents heart transplants performed, state by state, in 1996. Eleven states have no transplant performing hospitals. Others have multiple centers: California, Texas, Florida, and Pennsylvania, for example. The result is a system with a series of inefficiencies. Figure 4 In 1996, for example, 27 of 164 participating hospitals — 16.5 percent — received no useable hearts and therefore did no transplants. Another 27 hospitals did five or fewer operations. Only 16 hospitals — slightly less than 10 percent — did 30 or more procedures in that same year. This means a number of hospitals maintained heart transplant teams and surgeries that were under-used. That slack both adds to system costs — a criteria UNOS is dedicated to diminishing — and is symptomatic of regions with transplant potential but without an incentive for local donations that might generate higher activity through the neighbor effect. Analysis To the extent donation is based on local performance, the regionally weighted system creates disincentives to donation in under-served areas (some Western states) and geographically marginalized states like Alaska and Hawaii. The necessity for travel by transplant patients from these areas adversely affects UNOS' goal of minimizing costs for patients and insurers. As importantly, the current system creates regional inequities measured by mean waiting time. Equality is not maintained between patients waiting in disparate regions. Those with sufficient resources may overcome this disadvantage by listing as potential organ recipients at two or more transplant centers. This, however, shifts the responsibility of choice to patients who are sufficiently knowledgeable to seek the best deal and affluent enough to pay for the additional travel, doctors visits, etc. Thus equality is further diminished. Donation remains problematic for at least two reasons. First the "neighbor effect" is minimized by a system that requires many participants to travel away from home to receive their transplants. Where travel distance is significant — and from many areas the travel distance will be significant — incentives for donation by friends or neighbors of a patient are minimized. Secondly, lack of comprehensive health insurance limits donation in many regions. Populations which tend to have higher rates of non-insurance tend may live in cities housing large transplant centers (L.A., New York, etc.). Since neither they nor their neighbors are likely to be considered as organ recipients, these persons have little incentive to become organ donors. The system can be made more equitable, more efficient and perhaps more amenable to donation among disadvantaged communities. In those areas which are now clearly under-served (Western states, Alaska, Puerto Rico, etc.), locational analysis would suggest the creation of one or more new service centers to assure spatial continuities of service. This might both mitigate regional disparities and improve potential donation rates in these regions. Similarly, removing a regional bias in favor of a standard based solely on proximity would eliminate situations where cities New York and Newark, N.J., are procedurally distanced despite natural proximity. If a measure of travel time (say, three hours travel time between donor and recipient for a heart) were substituted for the metric distance system now used in defining proximity, greater equity — and greater national representation — would result. Finally, financial support for transplants to those in communities where health insurance coverage is now low also might increase donation rates. This could be done either through an insurer pool or by federal subsidies to participating hospitals, for example. Conclusion UNOS and the Department of Health and Human Services both suffer from conceptual parallax errors. Both seek improvements in a system whose objectives, while shared, remain unmet because of central, structural issues that demand address. UNOS' regional system appears to create a context of inequality between persons in different regions. Service areas are uneven. The number of people waiting for a transplant varies greatly between regions, as does the time they must wait for an available organ. Too many die before a suitable heart will become available. As importantly, however, inequalities in the general U.S. health care system may be adversely affecting organ donation, and thus the system at large. People without insurance — and thus the hope of a transplant — have little incentive to participate in the process. This is not a problem that can be fixed by revamping UNOS regions, or scrapping them altogether, however. Without structural changes at this level, donation levels among those disenfranchised by a lack of health insurance will probably remain low. References Koch, T. (1996), "Normative versus and prescriptive criteria: The efficacy of organ transplantation allocation protocols," Theoretical Medicine, Vol. 17, 75-93. Shalala, Donna (1998), Letter from Secretary of Health and Human Services to members of Congress. http://www/unos.org/Newsroom/archive_other_ 022698_shalala.htm. Federal Register (1988), Department of Health and Human Services: Organ Procurement and Transplantation Network, Final Rule, April 2, Vol. 63, 16288. Caldwell, Lynton K. (1996), "Science assumptions and misplaced certainty in natural resources and environmental problem solving," in Lemmons, John, "Scientific Uncertainty and Environmental Problem Solving," Cambridge, Mass., Blackwell Science, 394-421. Steinbrook, Robert, Feb. 6, 1997, "Allocating Livers-Devising a Fair System," New England Journal of Medicine, Feb. 6, 1997, 336 (6), 436-438. Weinick, R.M., Zuvekas, S.H., Drilea, S.K., (1997), "Access to health care — sources and barriers, 1996." Rockville (MD): Agency for Health Care Policy and Research. AHCPR Pub. No. 98-0001. AP (1998), "Many organ banks lag in transplants," Honolulu Advertiser, Sept. 8, A1, A7. Kasiske, B.L., London, W.B., Ellison, M.D. (1988), "Characteristics of Patients Placed on the Transplant Waiting List Before Requiring Dialysis," the American Society of Nephrology (ASN) 30th Annual Meeting, Nov. 2-5, 1997, Abstract. Ellison, M.D., Breen, T.J., Guo, T.G,; Cunningham. P.R.G., Daily, O.P. (1993), "Blacks and whites on the UNOS renal waiting list: Waiting times and patient demographics compared," Transplant Proceedings, 25:4, 2462-2466. Pierce, G.A., Graham, W.K., Kauffman, H.M., Wolf, J.S. (1996), "The United Network for Organ Sharing: 1984- 1994," Transplant Proceedings, 28:1, 12-5. Koch, Tom (1998), "The Limits of Principle: Deciding Who Lives and What Dies," Westport, Conn., Praeger Books, Chapter Five. UNOS (1994), "Rationale for objectives of equitable organ allocation," Richmond, Va. Reissued electronically in August 1998. http://www.unos.org/Newsroom/ archive_other_rationale_objectives.htm. Tom Koch is a research associate in bioethics, the Hospital for Sick Children, Toronto. He is currently at the University of Hawaii (Manoa), Department of Geography, Honolulu. He can be reached via e-mail at: tokoch@ibm.net. Table of Contents OR/MS Today Home Page OR/MS Today copyright © 1999 by the Institute for Operations Research and the Management Sciences. 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