Journal of Corporation Law
Symposium: Organ Donation
*109 ELIMINATING ARTIFICIAL BARRIERS TO THE EQUITABLE DISTRIBUTION OF HEARTS FOR TRANSPLANTATION
Erik S. Jaffe
John M. Herre, M.D.
John H. Carson, Ph.D. [FNa]
Copyright © 1995 University of Iowa (The Journal of Corporation Law); Erik S.
Jaffe, John M. Herre, M.D., John H. Carson, Ph.D.
Organ transplantation, once a rare medical miracle, has now matured to the point where over 16,000 people a year receive a transplant. But the number of people seeking transplants each year is substantially larger than the supply of available organs, which raises many difficult life and death questions about which patients will receive organs and in what order. Because this imbalance between organ demand and supply shows no sign of abating, society must have a fair and rational system for allocating its scarce organs. This Article examines the current system for allocating hearts for transplant, focusing primarily on whether present geographic limitations on heart distribution undermine the system's fairness and utility. Although much of the analysis in this Article applies to the distribution of other organs, particularly livers, the unique medical and logistical factors applicable to different organs require their separate treatment. Accordingly, this Article will limit its analysis and conclusions to the distribution of hearts.
Part I of this Article gives a brief description of the legal structure and policy rules surrounding heart procurement and allocation in the United States. Part II argues that the current system for allocating hearts is medically and equitably inappropriate because its distribution rules hinder organ sharing and place arbitrary geographic considerations above medical and equitable criteria. Part II also discusses the frequently raised alternative of allocating organs based on a single national list. Part III describes an alternative heart distribution model designed to eliminate the inadequacies identified in the present system. Part IV argues that the proposed distribution system is medically and equitably superior to both the current heart distribution system and a single national list, and presents preliminary data from a computer simulation of the proposed distribution system.
*110 I. CURRENT HEART ALLOCATION SYSTEM
National heart allocation [FN1] in the United States is governed by three types of rules. First are federal statutory requirements, setting the framework for a system of organ allocation throughout the country and providing for federal reimbursement of transplant service costs. Second are federal regulations promulgated to implement the statutes, which in general offer little guidance beyond the statutes themselves, particularly regarding the rules for allocation. Third, providing the most detailed guidance, are the quasi-public policies of the United Network for Organ Sharing (UNOS), the contractor hired to operate the organ allocation structure mandated by Congress. The UNOS policies, as a practical matter, play the most significant role in determining heart allocation. [FN2]
A. Statutory Structure
The National Organ Transplant Act (NOTA or the Act), passed on October 19, 1984 and amended in 1988 and 1990, [FN3] was enacted to establish a national framework for the effective procurement and equitable allocation of human organs for transplant. The Act directs the Secretary of the Department of Health and Human Services (HHS) to provide grants for the improvement of organ procurement and to establish by contract a national computer network to facilitate and coordinate organ procurement, sharing, and equitable allocation. [FN4]
The original 1984 Act commissioned "a comprehensive examination of the medical, legal, ethical, economic, and social issues presented by human organ procurement *111 and transplantation." [FN5] The resulting report, issued in April 1986, formed the basis for a variety of allocation-related amendments passed by Congress in 1988 and 1990. [FN6]
A central aspect of both the original and the current statutory schemes is the establishment of "qualified organ procurement organizations" (OPOs). [FN7] Each OPO is a private, non-profit organization responsible for procuring organs from donors within a defined service area and allocating those organs to patients awaiting transplants. An OPO's service area must be "of sufficient size to assure maximum effectiveness in the procurement and equitable distribution of organs." [FN8] Among other things, OPOs are required to "have a system to allocate donated organs equitably among transplant patients according to established medical criteria" and to "participate in the Organ Procurement (and) Transplantation Network established" by the Act. [FN9] An OPO's failure to "allocate() organs, within its service area and nationally, in accordance with medical criteria and the policies of the Network" can result in the cost of its procurement services deemed nonreimbursable expenses under Medicaid and Medicare. [FN10] Currently sixty- seven qualified OPOs operate throughout the country, with service areas ranging in size from a portion of an MSA (notwithstanding the statutory requirement to the contrary) to a multistate area, and a variety of sizes in between. [FN11]
The Act also requires the creation and maintenance of the Organ Procurement and Transplantation Network (OPTN) as the mechanism for national coordination and standard-setting for organ transplantation. The Secretary of HHS is directed by the Act to operate the OPTN via contract with a non-profit entity having transplantation expertise. [FN12] The duties of the OPTN include: establishing a "national list of individuals who need organs"; establishing a "national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included in the list"; establishing "membership criteria and medical criteria for allocating organs"; and "assist(ing OPOs) in the nationwide distribution of organs equitably among *112 transplant patients." [FN13] Congress has made it clear that the policies established by the OPTN are binding on all OPOs:
(W)ith respect to all organs within their control, (Organ Procurement Agencies) must comply with the policies established by the national organ transplant network regarding the allocation or (sic) organs, irrespective of whether the organ is placed through the network or is placed without the assistance of the network. This provision reflects the conferees' concern about wastage and criticisms of the allocation of available organs. [FN14]
The contractor that has operated the OPTN since its inception is the United Network for Organ Sharing (UNOS), based in Richmond, Virginia. UNOS establishes and periodically amends policies for hospitals, OPOs, and transplant centers to ensure that organs are obtained effectively and safely and are allocated according to medical and equitable criteria. [FN15]
A final provision affecting organ allocation makes it "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation." [FN16]
B. Federal Regulations Implementing NOTA
Current federal regulations implementing NOTA were enacted in 1988, after the 1986 enactment of the Medicare and Medicaid reimbursement conditions, but before the passage of the 1988 Transplantation Amendments. [FN17] As they relate to organ allocation, these regulations merely parrot the language of the early statutory scheme. Qualified OPOs are required to "(h)ave a system to allocate donated organs among transplant centers and patients according to established medical criteria." [FN18] An OPO service area is required to include a population of at least 2.5 million or contain at least fifty potential donors a year, unless the service area comprises an entire state. [FN19] Finally, a qualified OPO must "be a member of, have a written agreement with, and abide by the rules and requirements of the" OPTN. [FN20]
*113 A comparison between the current statutory language and the existing regulations shows that the regulations are no longer consistent with the statute. HCFA apparently drew the same conclusion back in 1991 when it issued a Notice of Proposed Rulemaking intended to make its regulations consistent with the significantly evolved statutory requirements. [FN21] These proposed rules once again simply parroted the revised statutory language. To date HCFA has issued no final rule. [FN22]
The most recent regulatory development in the area of organ allocation is the publication of a Notice of Proposed Rulemaking by the Public Health Service (of which HCFA is a part) concerning the operation of the OPTN. [FN23] The Proposed Rules, insofar as they relate to organ allocation, would require that the OPTN, through a newly created Board of Directors,
develop policies for the fair and equitable allocation of human cadaveric organs among potential recipients. Such policies shall be pat(i)ent-based and take into account significant factors affecting quality of care and patient and organ graft survival including: (1) established medical criteria for transplantation of organs; (2) the length of time potential recipients have been on the national list; (3) potential recipients whose immune system makes it difficult for them to receive organs; and (4) minimizing wastage of the scarce supply of human organs for transplantation. [FN24]
By wording its proposed rule in such a broad and nebulous manner, HHS has continued its practice of providing little or no guidance on what constitutes "fair and equitable allocation."
In addition to the above noted Proposed Rule regarding the development of allocation policies, HHS has solicited comments regarding the current organ specific allocation policies of UNOS, which the HHS views as proposed policies of the OPTN. [FN25] These policies must be reviewed and approved before they become legally binding rules or policies of the OPTN and therefore subject to enforcement via the withholding of Medicare and Medicaid reimbursement. Of particular relevance to the subject of this Article, the Notice of Proposed Rulemaking specifically requests comments on "moving toward single regional listings of potential recipients drawn from the national list for the purpose of allocating organs, and whether the use of regional listings is feasible and would lead to a fairer and more equitable allocation system." [FN26] The HHS itself offers no opinion on this subject.
*114 C. UNOS Policies Governing Heart Allocation
Within the broad statutory and regulatory outlines for organ allocation, UNOS has developed a series of policies governing the details of allocation on an organ-by-organ basis. Failure to comply with UNOS policies could disqualify charges by an OPO or transplant center from reimbursement by Medicare and Medicaid. [FN27] For heart allocation, the specific governing provision is UNOS Policy 3.7.2, which provides that "(t)horacic organs are to be allocated locally first, then within . . . (three zones) delineated by concentric circles of 500 and 1,000 nautical mile radii with the donor hospital at the center." [FN28] The local-regional-national structure of UNOS Policy 3.7 gives "local" patients first priority to receive "local" hearts, regardless of the comparative medical need of non-local patients. [FN29] For hearts, UNOS generally defines "local" as the OPO service area where the heart was donated. [FN30]
Within distribution areas, hearts are allocated based on the medical compatibility between the patient and the donated organ, patient medical status, and patient waiting time. [FN31] Heart transplant candidates are categorized as either "Status 1," requiring extensive "cardiac or pulmonary assistance," [FN32] in intensive care on specified drug regimens, or less than six months old; or "Status 2," including all other patients awaiting transplant. [FN33] Only when no acceptable recipient (Status 1 or Status 2) is found at the local level will a heart be distributed to patients at the regional or national level. [FN34] Hearts not used at the local level are offered first to Status 1 patients within 500 miles of the organ, next to Status 1 patients within 1000 miles, then to Status 2 patients within 500 miles, and then 1000 miles, and finally to patients anywhere in the country. [FN35]
One additional distribution level is the state-wide (or multi-OPO) distribution that results from UNOS promoted and approved sharing agreements. UNOS Policy 3.7.1 allows for "Variances" and "Inter-OPO Thoracic Sharing Agreements" that modify the applicable geographic distribution rules. In some cases, state-wide sharing between two *115 or more OPOs serves as the primary local distribution unit. In other cases, state-wide distribution intervenes between the local and regional levels, acting as an additional screen to keep as many organs as possible in-state. The current allocation system is summarized in Table 1.
TABLE 1: Current Heart Distribution Method
(Ranked from Highest to Lowest Priority)
Status/Category Description of Patients .... Allocation within Category
Local to Do-Nor
Status 1 Requiring extensive cardiac
or pulmonary assistance ... By time waiting in Status 1
Status 2 All other patients ......... By waiting time in Status 1 and
Status 2 combined
State or Inter-OPO
Status 1 Same as above .............. By time waiting in Status 1
Status 2 Same as above .............. By waiting time in Status 1 and
Status 2 combined
Status 1,Region A Status 1 within 500 miles
of the donor hospital .... By waiting time in Status 1
Status 1,Region B Status 1within 1000 miles
of the donor hospital .... By waiting time in Status 1
Status 2,Region A Status 2 within 500 miles
of the donor hospital .... By waiting time in Status 1and
Status 2 combined
Status 2,Region B Status 2 within 1000 miles
of the donor hospital .... By waiting time in Status 1
and Status 2 combined
Status 1 Status 1 anywhere in the
U.S....................... By waiting time in Status 1
Status 2 Status 2 anywhere in the
U.S....................... By waiting time in Status 1and
Status 2 combined
*116 In contrast to the numerous rules regulating distribution of hearts, heart transplant candidates are free to seek a transplant at any transplant center that will accept them. [FN36] Candidates often travel far from their homes to go to a preferred transplant center, or to one with more lenient medical criteria for accepting transplant candidates. [FN37] Regardless of the patients' home, they are listed on the local OPO waiting list for the transplant center where they will be treated. [FN38] Some patients awaiting heart transplants place themselves on more than one local waiting list and are prepared to travel to a transplant center in the locality where they are first offered an organ. [FN39]
II. CURRENT HEART DISTRIBUTION IS MEDICALLY AND EQUITABLY FLAWED
From its earliest interest in organ transplants, Congress was concerned that organs be allocated fairly. As explained in 1984 by the House Committee on Energy and Commerce:
(E)ven with implementation of (the National Organ Transplant Act), substantial questions will remain regarding the equitable application of organ transplantation. . . . These include assurance of equitable access to transplant procedures and the just allocation of a limited number of organs suitable for transplantation. . . . With the probability of unmatched demand, it becomes essential that publicly acceptable procedures be developed to allocate the limited supply of organs fairly to recipients and transplant centers. [FN40]
The necessity that organ allocation be both medically appropriate and equitable is emphasized repeatedly by Congress and by members of the transplant community. As originally enacted, NOTA established a Task Force to study the multitude of issues surrounding organ transplantation and directed the Task Force to prepare a report that included "recommendations for assuring equitable access by patients to organ transplantation and for assuring the equitable allocation of donated organs among transplant centers and among patients medically qualified for an organ." [FN41] The subsequent *117 amendments to NOTA emphasized that organs must be allocated equitably among patients, not transplant centers, [FN42] redefined the criteria for determining the size of OPO service areas to require that service areas be large enough to "assure maximum effectiveness in the procurement and equitable distribution of organs," [FN43] and expanded the national network's responsibilities to include the "nationwide distribution of organs equitably among transplant patients," [FN44] removing earlier language that limited national network distribution to "organs which cannot be placed within the service areas of the (procuring) organizations." [FN45]
Indeed, Congress specifically eschewed any requirement that organs be allocated based on OPO or state boundaries and instead stated that the geographic scope of organ sharing should be based upon medical, not political, criteria. In explaining the deletion of language regarding distribution within OPOs, Congress stated:
This phrase is deleted, so as to remove any statutory bias respecting the important question of criteria for the proper distribution of organs among patients. . . . Patient welfare must be the paramount consideration. The Committee does not wish the statute to be read as establishing a preference for, or against, distribution within the service area of the OPO. [FN46]
As UNOS recognizes, Congress assigned to the OPTN the task of deciding how organs are allocated based on medical criteria. [FN47] While each OPO must also equitably distribute the organs it procures, ultimately UNOS (and HHS) are responsible for defining equitable distribution and adopting policies accordingly. [FN48] UNOS has interpreted its statutory obligation concerning organ allocation to require a balance between medical utility and fairness. [FN49]
A. Balancing Utility and Fairness
The utility of an organ allocation system can be divided into two overlapping types: medical utility and social utility. Medical utility often is characterized in terms of saving or prolonging a patient's life or of improving the quality of a patient's life. [FN50] In *118 situations of scarcity where saving the lives of all patients is impossible, the medical utility of an allocation method is measured by the net number of lives saved, the length of time added to the lives of those saved, or the increase in the quality of life for those people receiving transplants. [FN51]
Social utility includes concerns that extend beyond the individual patients to the systemic effects of any given allocation system on individuals and social systems external to, or broader than, the transplant community itself. [FN52] Considerations include the relative cost of different allocation methods, [FN53] economic gains (or losses) to society from the extended lives and improved health of transplant recipients, and the relative incentives or disincentives for organ donation caused by the distribution system. [FN54]
Although medical utility frequently takes center stage in discussions of allocation, in a democratic society allocation criteria must extend beyond strictly utilitarian concerns and must be fair and equitable. It is by no means obvious that the allocation system that saves the most lives will also be the most fair or equitable allocation system. Unfortunately, there are many different views of what is fair and equitable. Likewise, little agreement exists on the balance between equity and utility when these two broad principles conflict. [FN55]
Issues arising under the rubric of fairness include, but are not limited to, concerns over equal opportunity for all patients to receive a transplant, the traditional notion of first-come first-served, concerns over the right of local communities to utilize local *119 resources, and concerns over freedom of choice for patients with regard to where and from whom they will receive their medical treatment.
B. Current Heart Allocation Inequities
Although many complaints have been leveled against different aspects of UNOS's organ allocation system, [FN56] this Article focuses on the arbitrary geographic restrictions on heart distribution that result from UNOS's local- regional-national allocation system. The present heart allocation system is objectionable because it fails to adequately coordinate the supply of donated hearts with the demand for heart transplants. The supply of hearts to any given OPO starts out primarily local in nature, based on the number and type of deaths in, and the organ donations of, the local population. Because patients may freely choose where they will list for transplant, demand for hearts within an OPO can include local, regional, and national patients. [FN57] Variations in demand are not matched by variations in supply, however, because present allocation policy allows localities to have priority for all locally procured hearts regardless of medical need and patient demand, thus erecting a barrier to national redistribution of scarce hearts.
UNOS itself has acknowledged that "(i)deally, allocation policy should not disadvantage certain patients because of the part of the country in which they live," yet concedes that under current policies "the availability of cadaveric organs can vary widely from one area to another." [FN58] With respect to hearts, the availability not only can, but does, vary widely from one area to another. For the United States as a whole, the availability of hearts (measured by annual procurement versus new transplant candidates added to the waiting list) is 0.61 hearts per new candidate. But, as can be seen in Table 2, the state-by-state availability of hearts ranges from a low of 0.32 hearts per new candidate to a high of 1.26 hearts per new candidate. [FN59] Measured relative to the national average, state heart availability ranges from 53 to 208 percent of national heart availability. Although several factors cause this variation in organ availability, the primary cause of the disparity is the current local-first priority system for distributing organs. "This approach has resulted in large differences in average patient waiting times from one local waiting list to another. . . ." [FN60]
*120 TABLE 2: Heart Availability--Hearts per New Patient
Procured . New Heart
Candidates Availability: Availability:
Added to Hearts per New Percentage
List Candidate of National
Oklahoma 27 ......... 84 0.321 53%
Louisiana 70 ......... 155 0.452 75%
Kansas 18 ......... 38 0.474 78%
Virginia 77 ......... 160 0.481 79%
Minnesota 54 ......... 109 0.495 82%
United States: 2,292 ...... 3,773 0.607 100%
Michigan 47 ......... 59 0.797 131%
Iowa 20 ......... 23 0.870 143%
South Carolina 19 ......... 21 0.905 149%
Hawaii 1 .......... 1 1.000 165%
Connecticut 24 ......... 19 1.263 208%
Based upon 1993 UNOS state-by-state data. The standard deviation from the national average is weighted by the number of new registrants per state, thus representing the standard deviation of heart availability per patient, not per state. National availability and standard deviation includes data from all states having heart transplant centers, not just those states displayed in the Table.
It is no surprise that the local-first distribution system fails to coordinate heart supply and demand; "local" OPO service areas were never designed with that goal in *121 mind. As UNOS observed when discussing its recent effort to redefine "local" as generally equivalent to an OPO's service area:
OPO service area boundaries are not based upon any consistent geographic or population-based criteria relating to size. Nor was any consideration given to either the number of transplant programs or the number of waiting patients in an OPO service area when service areas for OPOs were established. Consequently there are wide variations in the size of "local" patient waiting lists. It is not surprising, then, that average patient waiting times vary widely from one OPO to another. [FN61]
The failure of HHS to take into account the relationship between the size of OPO service areas and organ availability per patient directly contravenes the statutory mandate that OPO service areas be designed to "assure maximum effectiveness in the procurement and equitable distribution of organs." [FN62] Compounding the problems created by the arbitrary selection of OPOs as the first-order distribution units are: (1) current trends in the distribution of transplant patients that tend to concentrate patients in a limited number of the existing OPOs and (2) UNOS's encouragement and approval of state- wide or multi-OPO sharing units inserted between the local and regional levels.
Current efforts at health care reform, as well as medical economics, have increased the trend toward "centers of excellence" that concentrate transplant patients at select centers in a few OPOs. [FN63] As large health systems continue to seek economies of scale through centers of excellence, they transfer patients from one geographic area to another, and the OPOs in which such centers are located become more and more overcrowded with patients. The local donor pool available to such OPOs remains the same, however; and thus any existing imbalance between supply and demand is worsened. Conversely, centers of excellence create areas of relative oversupply in the OPOs from which they draw their patients and where there is no such center. The result is perverse. The aggravated imbalance between supply and demand causes patients at centers of excellence to face such high waiting times that they must either risk dying on the waiting list or go to less excellent and possibly more expensive centers. [FN64]
In addition to private centers of excellence, government health care providers, such as the military and the Veterans Administration, also concentrate their transplant patients at a relatively few transplant centers, likewise inflating demand in a few (unfortunate) *122 OPOs. [FN65] The VA, for example, currently maintains five heart transplant centers around the country. In 1992, one of those centers, the McGuire VA Medical Center in Richmond, Virginia, received nearly half of all VA heart transplant candidates in the country. Such local concentration of national patients has the same impact on supply and demand as does the local concentration of national patients in private centers of excellence: it overburdens the host OPO to the detriment of national and local patients alike. [FN66]
A second trend exacerbating the misalignment of supply and demand is the recent tendency of OPOs, encouraged by UNOS, to establish state-wide (or multi-OPO) sharing arrangements that create an additional layer of distribution before organs can be used at the regional level. Previously, if an organ could not be used at the local level, it was distributed regionally, thereby potentially satisfying some of the excess demand within other OPOs in the same region. As organs now are offered to other OPOs in- state before such regional sharing, the number of organs making it to regional distribution has dwindled, thus making it even harder for overburdened OPOs to obtain needed organs. Because the state-wide sharing is based on political rather than medical criteria, [FN67] it adds another opportunity to circumvent established medical criteria and transplant a lower-status patient that happens to be in the right state, at the expense of a higher-status patient just over the border. [FN68]
The geographic misalignment between supply and demand for hearts undermines a number of the goals of a sound allocation system. Medical utility is hurt because a seriously ill Status 1 patient in an overburdened OPO will be forced to wait an extended period of time for a transplant, even though an under-burdened OPO may simultaneously transplant a suitable heart into a Status 2 patient. [FN69] Fairness is also undermined by the *123 current supply and demand imbalances in that medically equivalent patients regularly face widely divergent waiting times, depending upon their geographic location and their economic status, the latter of which determines whether they can move to an OPO with a greater relative supply of organs or list at multiple hospitals in several OPOs. [FN70]
C. National Listing
One frequent response to reports of geographic inequities among transplant patients is to propose organ allocation based on a single national list of all patients awaiting transplant for a given organ. [FN71] Under such a proposal, the patient highest on the waiting list, based upon medical criteria and waiting time, would receive the next available organ regardless of where the patient was listed or where the organ was donated. Such a system would eliminate entirely the geographic barriers to organ distribution and presumably would give patients anywhere in the country an equal opportunity to receive an organ based upon medical criteria and waiting time. Proponents of this approach argue that it is more consistent with the intent of federal legislation requiring the establishment of a national computer list and directing UNOS to assist in the "nationwide distribution of organs equitably among transplant patients." [FN72]
In response to calls for a national allocation system, UNOS conducted a study of the efficacy of such a system in 1991. The result of this effort was the UNOS report, entitled The Feasibility of Allocating Organs on the Basis of a Single National List. [FN73] In this report, UNOS concluded that "it is not feasible to distribute any of the solid organs (i.e., heart, kidney, liver, lung, or pancreas) employing a single national waiting list." [FN74] With respect to hearts, the primary reason given for this conclusion was "the problem of preserving organs during transport across long distances." [FN75] UNOS also noted its expectation that under a national allocation system, "(m)any other transplantation-related *124 costs (i.e., organ and personnel transportation, increased hospital stays secondary to reduced organ quality) also would increase." [FN76]
III. A PROPOSAL FOR SUPER-REGIONAL HEART DISTRIBUTION
In order to avoid the inequities and inefficiencies of the present system, as well as the medical limitations on a national list, a more flexible distribution method is needed. This Article proposes a new heart distribution method based upon the concept of "floating super-regions," which requires the sharing of hearts among patients within a fixed distance from the point of donation. [FN77] This alternative heart distribution method would first distribute hearts based on existing medical criteria and then by waiting times (grouped according to standard deviations from the national average waiting time to transplant for medically similar patients). A final criterion would address logistical issues: where candidates are essentially equivalent, the organ would be offered to the patient closest to the donor, thereby reducing ischemia time and saving resources without sacrificing medical utility or fairness.
Under the proposed distribution system, all heart transplant candidates would register with UNOS as they do now. Each time a heart is donated, a list of candidates for that heart would be generated based upon identical blood type, acceptable weight range, and maximum distance the recipient center is willing to travel to recover a heart. [FN78] Patients on the list would be prioritized according to existing definitions for Status 1 and Status 2 patients.
Within a Status level, patients would be prioritized based on waiting time categories defined by standard deviations from the national average time-to- transplant of all medically similar patients transplanted in the previous thirty days. Waiting time for Status 1 patients would be calculated based only on time within Status 1, as currently calculated by UNOS. Status 2 waiting time would include time spent in either Status 1 or Status 2. Within each subcategory of the national list, in order to minimize ischemia time and travel costs, priority would go to the patient awaiting transplant at the center closest to the donor hospital. Hearts would be allocated as summarized in Table 3.
*125 TABLE 3: Proposed Heart Distribution Method
(Ranked from Highest to Lowest Priority)
Status/Category Waiting Time ......................... Allocation within
A one standard deviation (SD) above
the Thirty-Day Running Average
(TDRA) time to transplant for
medically similar patients ......... Closest patient first,
measured from donor
to recipient center
B TDRA to TDRA plus 1 SD ............. Same as above
C TDRA minus 1 SD to TDRA ............ Same as above
D 1 SD below the TDRA ............... Same as above
A 1 SD above the TDRA ................ Same as above
B TDRA to TDRA plus 1 SD ............. Same as above
C TDRA minus 1 SD to TDRA ............ Same as above
D 1 SD below the TDRA ............... Same as above
The selection of one standard deviation as the measuring unit for the temporal subcategories is somewhat arbitrary when the model is first initiated and could be adjusted as the model operates. The eventual goal is to have each temporal subcategory contain patients whose waiting times differ by a fairly small amount (one to two weeks). At the outset, standard deviations are likely to be much larger given the great disparities in waiting time that exist today. As the model operates, those disparities would substantially reduce, thus reducing the standard deviation from the average time- to-transplant. At that point, additional categories of plus or minus two standard deviations could be added to further refine the model.
IV. EQUITABLE ALLOCATION THROUGH SUPER-REGIONAL DISTRIBUTION
This Article does not address the basic medical requirements for allowing transplants to proceed in the first place: that is, a patient with at least some chance of recovery and an organ that is medically compatible. The proposed distribution system would accommodate such medical criteria, regardless of the particulars. The only position taken in this Article with regard to medical criteria for heart allocation is that such criteria should be applied uniformly and consistently to as large a group of transplant *126 patients as possible. In general, therefore, the distribution issue can and should be resolved separately from the other, potentially more difficult, allocation issues. [FN79]
A. Disparities in Waiting Times
As explained in Part II, the local-regional-national structure of current organ distribution causes wide disparities in waiting times around the country due to local differences in the balance of heart supply and demand. When two otherwise similar patients are forced to wait wildly different times to receive a transplant, then the perception and the reality of unfairness in the organ allocation system is created.
Moving to a single national list would effectively eliminate geographic disparities in the balance of supply and demand by causing all patients to face the same national supply of 0.607 hearts per new patient. Each patient would have as good or as poor a chance to receive a heart based on medical criteria as any other patient in the country. As a practical matter, no significant disparities in waiting times for medically similar patients should exist because of where patients are located.
TABLE 4: Super-Regional Heart Availability
(Based upon 1993 UNOS state-by-state data)
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******** This is piece 1. -- It begins at character 1 of table line 1. ********
Region Hearts Procured New Candidates Added
Eastern 1544 ........... 2642
Western 748 ............ 1131
United States: Patient-Weighted 2,292 .......... 3,773
******* This is piece 2. -- It begins at character 80 of table line 1. ********
Heart Availability:Hearts per New Heart Availability: Percentage
Candidate of National Availability
Substantially the same result--and potentially lower costs and improved ischemic times--can be achieved through the use of super-regions that are smaller in scope than the entire country. For example, simply breaking the country into Eastern and Western super-regions would create two supply and demand profiles that are only marginally different from the profile for the nation as a single unit. The heart availability figures under such a hypothetical approach for 1993 are set out in Table 4. Because no significant *127 disparities in heart availability exist at the super-regional level, one would expect patient waiting times to be similarly comparable if allocation began at that higher level. Within super-regions, one would likewise expect much smaller variations in patient waiting times because all similar patients are placed on the same list and subject to the same organ supply.
The proposed model using "floating" super-regions achieves the same result as a fixed super-region distribution system, but avoids some of the transportation and "border" problems, discussed in Part IV, inherent in any fixed boundary system. [FN80] As with the East and West super-region example, floating super-regions allow patients to have access to a greatly expanded donor pool and create a supply and demand profile that is comparable to the statistics for the nation as a whole.
To test the effect of the proposed model on patient waiting times, a computer simulation of national heart transplants was created. The simulation modeled donation, patient registration, and expected death rates without a transplant. Three different algorithms were run on the model. The first algorithm used the current UNOS heart distribution method, except that it substituted states for OPOs as the local distribution unit. The second algorithm used a single national list and allocated organs to the patient with the longest waiting time. Finally, the proposed distribution method using floating super- regions was modeled.
When running the current distribution system, the model recreated the existing situation of wide disparities in waiting time around the country. As can be seen in Table 5, waiting time for Status 1 patients averaged 54.4 days with a standard deviation of 54.6 days, illustrating the significant variations in patient waiting time. When a single national list was run on the simulation, waiting time for Status 1 patients averaged 15.6 days with a standard deviation of only 12.4 days, illustrating the much lower variation among significantly reduced Status 1 waiting times. Finally, the proposed floating super-region model created results very similar to the results of the national lists, and results that were much improved over the state-based model. [FN81]
Under the present system, significant regional sharing is virtually impossible due to the local-first rules that keep organs in-state. When regional sharing occurs at all, it is a haphazard exercise, due more to an absence of local patients rather than a presence of regional medical need. The distribution method proposed here, however, creates super- regions (delimited by the distance transplant centers are willing or permitted to travel), thus creating considerable size and diversity in the donor pool and improving the ability to match recipients in a reasonable time. Furthermore, because priority is determined by deviation from the national average waiting time for transplantation of similar patients, the model automatically prevents large waiting time disparities by giving highest priority to those people who have waited the longest.
*128 TABLE 5: Comparative Waiting Times to Transplant
(One year period; second year of model run)
State-Based .. National Super-regions
Status 1 Transplants 1448 ......... 1941 1954
Status 1 Average Wait to Transplant 54.4 ......... 15.6 18.6
Standard Deviation 54.6 ......... 12.4 13.9
Status 2 Transplants 607 .......... 114 101
Status 2 Average Wait to Transplant 343.2 ........ 1055.9 1070.6
Standard Deviation 322.9 ........ 464.9 574.1
Total Transplants 2055 ......... 2055 2055
B. Deaths While Waiting for a Transplant
In general, deaths while waiting are a function of the time spent waiting. The longer a patient must wait on a list, the less likely the patient will live to transplantation. [FN82] The effect is even more pronounced for Status 1 patients, who by definition are in intensive care and subject to great efforts to keep them alive. Such patients generally have little time to live absent a transplant. Status 2 patients are also subject to the risk of death over time, but given that they are generally in better condition than their Status 1 counterparts, the time they have before dying is considerably longer on average.
Because that Status 1 patients face a more imminent death than Status 2 patients, any distribution scheme that allows transplantation of Status 2 patients before Status 1 patients will increase the number of deaths while waiting. This is precisely what happens under current UNOS policies and is precisely the problem that the proposed model is designed to eliminate. By expanding the pool of patients eligible for each organ, the proposed model reduces the likelihood that a Status 2 patient will be transplanted before a similarly suitable Status 1 patient. (The exception is where the Status 1 patient is too far away to make use of the organ, in which case transplanting the Status 2 patient would not offend any medical criteria.) As UNOS pointed out in the context of livers, *129 transplanting urgent patients can improve listed patient survival because such patients are more likely to die before an organ becomes available. [FN83]
TABLE 6: Comparative Deaths While Waiting (DWW)
State-Based .. National List Super-regions
Status 1 DWW 644 .......... 271 303
Status 1 Average Wait to Death 35.2 ......... 12.5 12.3
Standard Deviation 40.3 ......... 12.1 11.6
Status 2 DWW 656 .......... 804 789
Status 2 Average Wait to Death 150.5 ........ 197.1 204.1
Standard Deviation 210.1 ........ 256.4 264.4
Total DWW 1300 ......... 1075 1092
As with waiting times, the impact of the proposed model on deaths while waiting was tested using the computer simulation. The results of the simulation demonstrate that the floating super-region model substantially reduces the number of Status 1 deaths while waiting, slightly increases the number of Status 2 deaths while waiting, and leads to a net reduction of deaths while waiting of 208 patients over the course of a year. The effects of the different models on deaths while waiting are set out in Table 6.
C. Patient and Graft Survival
The primary means by which the proposed model would affect patient and graft survival is by allowing the more uniform application of UNOS medical criteria across the pool of transplant candidates. Assuming that UNOS medical criteria for allocation (excluding distribution policy) tend to maximize medical utility, those criteria can only be effective if they are applied consistently. When patients are transplanted in an order that deviates from UNOS medical criteria, a loss of medical utility occurs, all other things being equal. [FN84] For example, under the current distribution system, if an OPO lacks a compatible Status 1 patient for a given organ donated locally, it will offer the *130 organ to a local Status 2 patient, notwithstanding the existence of a compatible and more urgent Status 1 patient in another locality. In the state-based allocation simulation, for example, over the course of one year 264 instances arose in which an in-state Status 2 patient received an organ despite the existence of a medically suitable out-of-state Status 1 candidate. Likewise, 793 instances arose in which an in-state Status 1 patient received an organ despite the existence of a medically suitable out-of-state Status 1 patient who had waited longer. The medical criteria for transplantation are given lower priority than OPO parochialism, reducing the net medical utility of the system.
The benefits of the proposed model are identical regardless of how the transplant community eventually comes down on the hotly-debated allocation question of whether it is preferable to transplant first those patients in most urgent need or those with the best prospects for survival post-transplant. [FN85] For example, if the medical community one day determines that it is medically and equitably superior to transplant healthier Status 2 patients before transplanting debilitated Status 1 patients, such revised medical criteria would also be distorted under the current UNOS distribution policy. An OPO, lacking an appropriate Status 2 patient would next transplant a local Status 1 patient with supposedly poor chances of long-term graft survival, despite the existence of any newly-favored Status 2 patients in other OPOs.
A number of other advantages to patient and graft survival derive from the proposed model. First, by expanding the pool of organs available to each patient, the odds improve that a more accurate match can be made between patient and donor without incurring undue waiting or ischemia time. Exact ABO matches between donors and recipients, for example, might improve graft survival. [FN86] The expanded pool also makes it possible for the first time to consider using HLA matching for heart transplants. Although HLA matching is not used currently for allocating hearts, a recent study has concluded that by allocating hearts among combined waiting lists of one thousand patients, a substantial increase in HLA-A, B, and DR matches could be achieved, with a potential overall five percent increase in transplant survival over three years. [FN87]
Second, by channeling organs to patients who most urgently need them, and by creating predictability for all patients on the waiting list, pressure is reduced on transplant centers to use substandard organs. As UNOS recently noted: "Because of the widening *131 gap between the number of donors and recipients, increasing interest has been placed on the use of .expanded' donors--donors previously considered less than optimal for such reasons as age, hypertension and other factors." [FN88] But use of such donors poses a greater risk of mortality for the recipient, with donor age being "one of the most powerful independent predictors of early mortality following cardiac transplantation. . . ." [FN89] By ensuring that patients facing the greatest risk of death receive timely access to organs, the proposed model will reduce some of the pressure to use substandard organs. And, although the proposed model will not eliminate the growing shortage of organs that generally drives the use of expanded organs, it will make the availability of organs more predictable, providing doctors with the information they need to make a rational choice regarding the costs and benefits of using these more risky organs.
Both benefits of the proposed model are a function of initially selecting from a larger, more diverse group of patients for each available organ (or, looked at another way, selecting from a larger group of organs per patient). Larger and more diverse groups (of either patients or organs) have a greater chance of containing a medically preferred match than do smaller groups. Closer ABO matching, for example, would reduce the risk of graft rejection, thus increasing patient survival.
D. Transplant Opportunities for Hard-to-Match Patients
In the same way that the proposed model improves patient matching generally, it likewise improves the chances to match biologically or medically disadvantaged patients. Because each patient is matched against a much larger and more diverse pool of organs, a hard-to-match patient is more likely to receive whatever unique organs might be available. Furthermore, if a patient is difficult to match, that patient eventually will reach the higher priority subcategories and may well be alone in such a subcategory. That patient then would have first priority for every matching organ in the country that could be transported within viability constraints. The increased number of organs available, and the eventual high priority for such organs would improve the chances of finding a timely match for such a disadvantaged patient. [FN90]
E. Ischemic Time
The most frequently voiced objection to any allocation system that expands the geographic scope of organ sharing is that such a system results in organs traveling farther and therefore being out of the body longer with a greater risk of damage to the organ. [FN91] The current local-first distribution scheme is thought to minimize ischemic time by giving preference to closer patients. Indeed, UNOS itself has used the issue of ischemic time to dismiss without analysis the question of expanding heart distribution. *132 In its 1991 National List Report, UNOS asserted: "It is largely because (extra-renal) organs, especially hearts, must be transplanted with minimal ischemic times, that a national system of extra-renal organ allocation is also likely not feasible at this time." [FN92]
This argument, however, proves far less than its proponents claim and by no means provides a satisfactory justification for the current allocation system. OPO service areas--the presumptive local allocation unit--are unrelated to concerns about ischemic time because service areas vary widely in size, and patients at centers within the donor's OPO have priority regardless of whether they are in fact closer to the donor's hospital than patients at transplant centers in other OPOs. [FN93] Indeed, because an OPO's service area has a fixed geographic definition, "border" problems inevitably arise where hearts procured near the boundary of the OPO actually are closer to some patients in the neighboring OPO than to other patients in the procuring OPO. [FN94] In the state-based computer simulation, for example, over the course of a year ten instances occurred in which an in-state Status 2 patient received an organ despite the existence of a suitable out-of-state Status 1 patient who was closer to the organ. Likewise, fifty-eight instances occurred in which an in- state Status 1 patient received an organ despite the existence of a suitable out-of-state Status 1 patient who had waited longer and was closer to the organ.
The above irrationalities of the present system notwithstanding, the proposed model on average will increase the travel distance for transplanted hearts. For example, if the highest ranking patient for a particular heart was located outside the procuring OPO, the proposed model would require that the heart be transported to that patient regardless of the presence of eligible but lower ranking patients within the procuring OPO. Indeed, the proposed system intentionally risks increased transportation time and costs to eliminate significant deviations from established medical criteria and to reduce differences in waiting time between medically similar patients.
Even though the proposed model will on average transport organs further than they would be transported under the present system, the magnitude of that increase does not threaten patient welfare. In the computer simulation, for example, average travel distance under the super-regional model was 665.8 miles; greater than the 167.0 mile average under the state-based model, but less than the national list model's 1047.3 mile average. Even though the super- regional model increases travel distances, the average travel distance is still well within the limits of heart ischemic time constraints. [FN95]
*133 As for the impact on ischemic time, much depends on the mode of transporting the organs over different distances. For example, an organ traveling 90 miles by ambulance might take as long to arrive as sending that same organ 250 miles by airplane. Distance traveled is only a first approximation for ischemic time. Where the increase in distance leads to the use of alternative modes of transportation, it is conceivable that, at the cutover point, ischemic time might well decrease despite the increase in distance. For distances below 100 miles it seems unlikely that a jet airplane would be used; above 100 miles the potential for using air transportation increases. Five hundred miles is considered by UNOS to involve a one hour flight by jet. [FN96] Any increased use of jet aircraft under the proposed model would mitigate and in some cases outweigh the potential for increased ischemic time due to increased travel distance.
F. Access to Transplantation
Another argument often raised in defense of local-first distribution is that preferential access to local organs is needed to support local transplant centers and to give local patients the option of having a transplant locally. [FN97] Although it is certainly desirable that local patients have the option of local transplants, local-first distribution is not necessary to sustain local centers. Indeed, under current UNOS policy, many local programs are actually disadvantaged because within their OPO there also exists a regional or national program that places a great strain on local supplies of organs. [FN98] Rather than local organs allowing local transplants, OPO boundaries often act as a limiting factor on available organs and thus contribute to the distribution problems created by outside patients migrating to national transplant programs.
Even where a small local transplant center is alone in its OPO, however, it may still face significant problems due to the lack of diversity in a small list of candidates and a limited number of donor organs. While the OPO may procure a sufficient number of organs in the abstract, if those organs do not match the local candidates, the local center will be unable to meet patient needs, and local access becomes a false hope. Finally, in those localities that do not have national transplant centers, but nonetheless have enough organ donors to provide both sufficient numbers and adequate diversity of blood types and sizes, local access provides not equal opportunity but greater opportunity for local transplants. It is precisely such localities where patients end up waiting below the national average waiting time and where Status 2 patients are transplanted *134 before Status 1 patients in surrounding areas. In some cases the organ-to-patient ratio in such OPOs is further improved because a number of patients may choose to leave the local OPO to have their transplants performed at nationally recognized transplant centers. Local demand is reduced while local supply remains constant, thereby further improving the situation of those patients who remain.
In a truly equitable allocation system, patients would have an equal chance to obtain an organ regardless of where they were listed. If organ availability remained constant regardless of where a patient went for a transplant, the patient could choose a transplant center based on local convenience, preference for a particular doctor or program, or any other reason important to the individual patient. Patients would not have to worry about whether they will be disadvantaged at their preferred center due to variable organ availability. The proposed model is designed to accomplish just that: waiting time at every center approximately equal to the national average for similar patients, regardless of location. Thus, local patients would be no better and no worse situated than patients who were financially and physically able and willing to travel elsewhere for a transplant. Similarly, local transplant centers could rest assured that their patients would have equal opportunities for transplants. Under the proposed model, once local patients spend their fair share of time in the queue, they have the same priority for hearts as comparable patients at regional or national centers. Under those conditions, equitable local access would become a reality rather than mere lip service.
A related issue that should be noted is that many localities feel they have a vested right to the organs donated in their area and procured by their OPO. [FN99] While local communities historically have favored local charities and sought to benefit first those people in their own back yard, this approach is inappropriate in the area of organ allocation. Organ donations have long been viewed as an act of national charity, given to those persons in greatest need regardless of where they are located. The Task Force on Organ Transplantation expressed its view that donated organs "constitute a national resource to be used for the public good." [FN100] The federal involvement in the area of organ transplants further demonstrates the national, rather than local, character of transplantation. In this context, organs should not be treated as a species of local property, but as donations to a national cause that are meant to be distributed fairly to all. A sense of local ownership of donated organs undermines the intended national orientation of transplant policy, "inhibits further cooperative achievements and . . . impedes the development of a more equitable system for distributing organs among patients." [FN101] Though the proposed model takes a national view, it does not abandon localities. In fact, in many ways, the new model helps localities by assuring them access to a national *135 supply of organs based on the genuine needs of patients. Local hospitals in currently overburdened OPOs would no longer have to compete for limited resources with large national programs in their backyards, but would instead have access to national organs on an equal basis with any hospital in the country.
G. Overall Transplantation-Related Costs
In any system designed to allocate scarce and expensive resources, the cost of different distribution methods must be considered. But cost must not be allowed to dominate the medical and equitable considerations mandated by Congress. In the area of heart transplants, alternative distribution models probably will affect transportation costs for patients and organs and potentially will affect costs related to patient conditions before and after transplant.
Under the proposed model, the impact on patient travel is unpredictable. Certainly many patients under the proposed model will choose to stay close to home once they know that moving to a different center will not increase their chances of obtaining an organ. For those patients, travel-related costs will decrease. Other patients--particularly those in areas currently enjoying a relative abundance of organs--might choose to leave home and travel to regional or national centers of excellence because they will no longer be disadvantaged by listing themselves at a popular center. They will have the same opportunity to receive an organ regardless of where they are listed. The current system penalizes two classes of patients: those at centers of excellence and local patients at other centers in the same OPOs as the centers of excellence. In each case, the importation of patients into the OPO raises waiting times for all patients in the OPO. The proposed model eliminates that penalty for both groups. How these two conflicting incentives on patient travel will eventually play out is unpredictable given the unpredictability of individual patient (and, increasingly, provider) choices and valuations.
The proposed model will likely cause some increase in organ transportation costs due to an increase in the average distance organs will travel. Some circumstances under the proposed model, however, might reduce organ transportation costs. Under the present system, during 1993, approximately twenty-eight percent of donated hearts were transported outside the procuring OPO. [FN102] Indeed, once it is determined that no recipient is available within the OPO, an organ will be flown to the highest-status, longest- waiting patient within a 500 and then a 1000 mile radius. Furthermore, even where a medically equivalent patient within the applicable distribution zone is closer to the donor, but has marginally less accumulated waiting time, the current system will send the organ the extra distance to the marginally longer waiting patient. The proposed model, on the other hand, would reduce the impact of small differences in waiting time and instead aggregate patients into waiting groups who have all waited roughly--though not exactly--the same amount of time. Within such a waiting group of medically equivalent patients, an organ would be distributed to the closer patient, thus reducing travel cost and ischemic time without sacrificing utility or fairness. [FN103] Where significant differences in waiting time existed, however, the proposed model is more likely to transport *136 organs to reduce those differences. At least initially, given the disparities in the current system, total organ transportation costs could increase. As waiting times flattened out, however, and more patients have roughly equivalent waiting times, organs can be allocated to the closer patients and transportation costs will diminish. Again, how these conflicting effects on organ travel play out is hard to predict.
Another cost consideration is the length and nature of patient care both before and after transplant. Status 1 patients generally await transplant in extremely expensive intensive care units. By reducing Status 1 waiting time, the proposed system would reduce this costly aspect of pre-transplant care. Data from the computer simulation supports this common-sense conclusion. A comparison of Status 1 patient waiting time prior to removal from the list by either death or transplant shows that the super-regional model results in a net reduction of 61,369 patient-days of time spent waiting in an intensive care unit for a transplant. Given the high cost of intensive care, this translates into tens of millions of dollars in pre-transplant cost savings over the state- based model. The super-regional model also reduces, by 165 patients, the number of Status 1 candidates remaining on the list as compared to the state-based model, again resulting in a tremendous cost savings. These combined savings in intensive care costs should more than outweigh any increased transportation costs resulting from increased organ travel. As for post-transplant medical care, all patients take time to recover from transplant surgery, and there is no reason to believe that Status 1 patients will have a disproportionately long recovery period, or that any potential increased recovery expense would rival the tremendous pre-transplant cost savings under the proposed model.
A final matter is the impact of distribution methods on centers of excellence. The present distribution system cuts against the medical and economic benefits of centers of excellence because OPOs are incapable of supplying organs to satisfy such concentrated demand in a timely manner. As patients at centers of excellence are forced to wait longer before receiving an organ, the costs incurred by those patients increase (thus offsetting any volume efficiencies). Patient survival, both before and after the transplant in a center of excellence, is likely to decrease as a result of patients dying while waiting and patient health deteriorating during the long wait. Only with a system that draws from pools of potential donors large enough to service large pools of potential patients is there the opportunity to concentrate patients at hubs within the overall catchment area without worsening any existing imbalance between supply and demand for organs. [FN104]
H. Availability of Transplantable Organs
UNOS has identified maximizing the availability of organs as one of its objectives for organ allocation policy. [FN105] Other than deaths in the general population, the two factors most affecting organ availability are the rate of organ discard and the rates of donation and procurement. Regarding the first factor, avoiding organ discards is without question a legitimate goal of any distribution system. The proposed model serves this *137 goal by requiring doctors (and allowing UNOS) to set the maximum distance that an organ can be transported. [FN106] Such maximum distances ensure that no heart will travel for longer than its viability limit.
Regarding attempts to improve procurement and donation through allocation policy, however, the appropriateness of such efforts is subject to serious ethical question, and the effectiveness of the current system in meeting such a goal is doubtful. While it is certainly true that improving procurement is an important objective for UNOS in general, it is far less clear that organ allocation or distribution policy either can or should provide affirmative incentives for donation or procurement. If UNOS wishes to encourage donation and improve procurement, it should follow its other mandates regarding public and medical profession education to increase awareness of the importance of donation and procurement. It could also take steps to promote compliance with federal "required request" rules to increase procurement efforts. Furthermore, UNOS has repeatedly rejected the argument that maximization of donations requires that recovered organs benefit the hospital or metropolitan area from which an organ is recovered. This argument was first rejected in 1992 when UNOS selected its current definition of "local" as equivalent to the whole OPO and required OPO-wide sharing lists. This choice reversed prior practice in which an organ would often go first to the hospital or city in which the donation occurred. UNOS rejected the argument a second time in mid-1993 when that argument was used in support of Alternative Local Units--and localized waiting lists--smaller than a whole OPO. Finally, incentives for procurement do not qualify as "medical criteria," and consequently it would be inconsistent with federal law to use such incentives as even a partial criterion in determining distribution policy. Distribution-based procurement "incentives" ultimately amount to bribes for transplant centers to procure organs. The procuring center is "paid" through the increased opportunity to transplant its own patients. Unfortunately, the people paying for such incentives are patients waiting in other parts of the country who--based on medical and equitable criteria--have a stronger claim to available organs, but who will not receive them because they are being distributed elsewhere as "incentives." Playing games with patients' lives in this manner is not an ethically acceptable means of encouraging donation.
Even if such procurement incentives were appropriate considerations for organ allocation policy, there is considerable reason to believe that local distribution-based incentives would be ineffective or counter-productive. Although it is often claimed that, in order to have an incentive to procure organs, transplant surgeons "must have some assurances that their patients (and their particular programs) will derive some benefit from the effort," [FN107] the Office of the Inspector General of HHS has characterized such claims as resting on "fragile foundations" and as having "no valid statistical basis." [FN108] A related claim made by proponents of local distribution is that the public's willingness to donate organs will decline "if residents of a particular OPO service area found that organs donated in their area were being sent to other areas." [FN109] This claim also lacks empirical support and, in fact, is contradicted by such evidence as does exist. Even *138 UNOS has acknowledged that no evidence exists linking donation rates to the degree of localization. [FN110] Furthermore, the Office of the Inspector General of HHS, in addressing the issue of public incentives for organ donation "found that in a national public opinion poll, commissioned by the OPTN itself, over 75 percent of the respondents disagreed with the statement that .donor organs should go to someone in the area where the donor lived."' [FN111] Local organ distribution thus cannot be defended on the basis of insupportable claims of procurement and donation benefits.
Finally, although maximizing organ recovery should not be the goal of the distribution system, it is still worth noting that an unfair system may hinder other efforts to increase organ donation. The best way for the distribution system to encourage and support donation is by the system being scrupulously fair and equitable in and of itself. [FN112] Only when distribution policies abandon medical criteria, and allow localities to hoard organs regardless of a greater need elsewhere, does charity risk turning into cynicism.
Present heart distribution policies give excessive and inappropriate weight to geographic factors, while giving too little weight to medical and equitable criteria such as patient status and waiting time. There exists virtually no evidence of the medical benefits suggested for UNOS's local-first distribution policy. Yet the tremendous disadvantages of that policy, in the form of widely varying waiting times and high rates of death while waiting for transplant are plain for all to see. The heart distribution model proposed in this Article is designed to eliminate at least the most obvious flaw in current distribution policies--the geographic barriers to equitable heart distribution. The proposed model does not address every open issue concerning heart allocation. Likewise, the proposed model is not without its costs and is not the proverbial free lunch; but it is not presented as such. What the proposed model represents is a tremendous improvement over a distribution system based on geography rather than medical criteria and essential fairness.
A computer simulation of state-based, national, and super-regional distribution models demonstrates that expanded organ sharing is feasible, can save lives, and can be accomplished without many of the perceived problems of a single national list. Although increased organ sharing exacts a cost in organ transportation, that cost can be kept within medically reasonable limits, is outweighed by cost savings from reduced pre-transplant medical care, and can greatly enhance the nationally uniform application of medical criteria and improve the equity of the distribution system.
[FNa]. This Article is based upon the presentation given by Erik S. Jaffe at the Organ Transplant Symposium held at the University of Iowa College of Law on April 9, 1994. Erik S. Jaffe is an attorney at the law firm of Williams & Connolly in Washington, D.C. John M. Herre, M.D., is a Professor of Internal Medicine at Eastern Virginia Medical School and is affiliated with Sentara Norfolk General Hospital in Norfolk, Virginia. John H. Carson, Ph.D., is a Professor of Management Science at the School of Business and Public Management, The George Washington University, in Washington, D.C. The authors would like to thank Glenn R. Barnhart, M.D., Grace R. Hines, F. Whitten Peters, Esq., Jennifer Carson, and Mark M. Oh for their generous support and assistance in the work that led to this Article. Any flaws in logic or execution, however, are solely the authors'. Some of the research for this Article was conducted as part of Williams & Connolly's representation of Sentara Norfolk General Hospital.
[FN1]. "Allocation" refers to the entire set of rules that determine which patients receive which organs and in what order. "Distribution" refers to a subset of allocation that is concerned with the geographic boundaries that determine which patients are eligible for consideration for any given donated organ.
[FN2]. A number of states have passed laws governing organ allocation that require in-state patients to receive priority over out-of-state patients for organs procured in-state. See, e.g., Jeff Testerman, Organ Transplants: Who gets priority?, St. Petersburg Times, Feb. 24, 1992, at 1A (discussing state- allocation-first policies in Florida and other states); United Network for Organ Sharing, The UNOS Statement of Principles and Objectives of Equitable Organ Allocation 10, 15 (1994) (hereinafter Principles and Objectives) ("Some states have had, and may continue to have, laws preventing organs donated in the state being sent to a patient outside the state unless there are no suitable transplant candidates within the state."). These laws, to the extent they are not inconsistent with federal requirements, create a fourth level of regulation governing organ allocation. Whether state laws take precedence over UNOS policies not formally approved by the Secretary of Health and Human Services remains open to question and has never been addressed in court.
[FN3]. See National Organ Transplant Act, Pub. L. No. 98-507, 98 Stat. 2339 (1984) (hereinafter NOTA) (codified in scattered sections of 42 U.S.C.); Organ Transplant Amendments Act of 1988, Pub. L. No. 100- 607, 102 Stat. 3114 (codified in scattered sections of 42 U.S.C.); Health Omnibus Programs Extension of 1988, Pub. L. No. 100-607, 102 Stat. 3048 (codified at 42 U.S.C. SS 273, 274, 274a-274e (1988)); Transplant Amendments Act of 1990, Pub. L. No. 101-616, 104 Stat. 3283 (codified as amended in scattered sections of 42 U.S.C.).
[FN4]. 42 U.S.C. SS 273, 274 (1988).
[FN5]. H.R. Rep. No. 769, 98th Cong., 2nd Sess. 9 (1984).
[FN6]. See Task Force on Organ Transplantation, U.S. Department of Health & Human Servs., Organ Transplantation: Issues and Recommendations (1986) (hereinafter Task Force); Health Omnibus Programs Extension of 1988, 102 Stat. at 3116; Transplant Amendments Act of 1990, 104 Stat. at 3279.
[FN7].42 U.S.C. S 273(a) (1988).
[FN8]. Id. S 273(b)(1)(E) (Supp. 1990)>. The specific delineation of service areas is the responsibility of HHS and is carried out by the Health Care Finance Administration (HCFA). 42 C.F.R. SS 485.301-308 (1993). The Act forbids the division of any metropolitan statistical area (MSA) between 2 or more organ procurement organization (OPO) service areas. A service area must include all of an MSA or none of it. 42 U.S.C. S 273(b)(1)(E) (Supp. 1990).
[FN9]. 42 U.S.C. S 273(b)(3)(E), (H) (Supp. 1993).
[FN10]. Id. S 1320b-8(b)(1)(E) (1988); 42 C.F.R. S 485.307 (1993). Because OPO certification is not organ- specific, the loss of "qualified" OPO status deprives hospitals of reimbursement for all charges regarding all organs procured by the unqualified OPO, regardless of whether the OPO's noncompliance related only to one type of organ.
[FN11]. Organ Transplant and Bone Marrow Donor Reauthorization: Hearings Before the Subcomm. on Health and the Environment, 103d Cong., 1st Sess. 36 (1993) (hereinafter 1993 Transplant Hearings) (statement of Kathleen A. Buto, HCFA); id. at 13 (statement of Mark V. Nadel, GAO); see supra note 8 for an explanation of metropolitan statistical area (MSA).
[FN12]. 42 U.S.C. S 274(a), (b)(1) (1988).
[FN13]. Id.S 274(b)(2)(D) (1988).
[FN14]. H.R. Conf. Rep. No. 1012, 99th Cong., 2d Sess. 319 (1986), reprinted in 1986 U.S.C.C.A.N. 3964; see also 42 U.S.C. S 1320b-8 (1988).
[FN15]. The scope and authority of UNOS policies will be discussed further infra part II.B.
[FN16]. 42 U.S.C. S 274e(a) (1988). Much of the scholarly debate concerning this issue is devoted to how the prohibition of direct monetary incentives to organ donors affects donation and procurement. See Task Force, supra note 6, at 96 (stating that "society's moral values militate against regarding the body as a commodity"); Richard E. Epstein, Organ Transplantation: or, Altruism Run Amuck, Occasional Papers from the Law School, the University of Chicago, Number 31, Dec. 1, 1993, at 1 (advocating an open market for organ sales). Less attention is paid to the impact this provision has on the selection of organ recipients, perhaps due to a widespread assumption within the transplant community and elsewhere that wealth should not be the criteria for access to lifesaving medical care. See Task Force, supra note 6, at xxi (stating that "patient financial status should not limit the availability of" transplantation).
[FN17]. See 42 C.F.R. S 485 (1993).
[FN18]. Id. S 485.304(i).
[FN19]. Id. S 485.302.
[FN20]. Id. S 485.305.
[FN21]. See 56 Fed. Reg. 28,513 (1991).
[FN22]. On September 8, 1994, HCFA issued an Interim Final Rule modifying the OPO regulations in 42 C.F.R. Part 485. >59 Fed. Reg. 46,500 (1994). The Interim Final Rule, which was subject to public comment, increased the organ procurement requirements for OPO's, but offered no new guidance on the issue of equitable distribution. See 59 Fed. Reg. at 46,514-17.
[FN23]. 59 Fed. Reg. 46,482 (1994) (to be codified at 42 C.F.R. pt. 121) (proposed Sept. 8, 1994).
[FN24]. Id. at 46,497.
[FN25]. Id. at 46,487-88.
[FN27]. See 42 U.S.C. S 1320b-8 (1988). Although federal law appears to make compliance with UNOS policies mandatory, subject to loss of eligibility for Medicare and Medicaid reimbursement in the event of non-compliance, HCFA has taken the position that UNOS policies are binding only after they are approved formally by the Secretary of HHS. See 54 Fed. Reg. 51,802-03 (1989). Although the legal effect of unapproved UNOS policies remains open to debate, see 1993 Transplant Hearings, supra note 11, at 11-12 (testimony of Mark V. Nadel, GAO). HCFA's enforcement position, as a practical matter, renders those policies only precatory. Notwithstanding the uncertain legal status of UNOS policies, OPOs and transplant centers generally have refrained from open violation of those policies.
[FN28]. UNOS Policy 37.2 (United Network for Organ Sharing 1994) (hereinafter UNOS Policy).
[FN30]. UNOS Policy 3.1.7.
[FN31]. Id. 3.7.3 to 3.7.6.
[FN32]. Id. 220.127.116.11. The type of assistance required to place a patient in Status 1 includes "(i) total artificial hearts; (ii) left or right ventricular assist system; (iii) intra-aortic balloon pump; or (iv) ventilator." Id.
[FN33]. Id. 18.104.22.168. In a number of OPOs, UNOS has approved variances in the definitions of patient medical status, typically subdividing Status 1 into two subcategories that draw even finer distinctions between patients having greater or lesser medical urgency. See Summary of UNOS Approved Thoracic Organ Allocation Variances, August 16, 1994.
[FN34]. UNOS Policy 3.7.2 & 3.7.7.
[FN36]. See Principles and Objectives, supra note 2, at 10, 15.
[FN37]. In addition to the voluntary redistribution of patients, certain patients, such as those in the VA hospital system, are not given a choice, but often are required to relocate to one of a few VA regional transplant centers. See Referrals for Heart Transplants, Directive from Dept. of Veterans Affairs, Veterans Health Admin. to Regional Directors, Directors, VA Medical Center Activities, Domiciliary Outpatient Clinics, and Regional Offices with Outpatient Clinics, Attachment C (March 11, 1993) (VHA Directive 10-93-028, on file with author); Principles and Objectives, supra note 2, at 15.
[FN38]. Principles and Objectives, supra note 2, at 8 (stating that the local list "includes patients who are registered for transplants at specific transplant centers within the OPO service area where the donor is located").
[FN39]. See Notice of Proposed Rulemaking, 59 Fed. Reg. 46,482, 46,484 (1994) ("Three percent of waiting list patients are listed at two or more centers."). This Article does not address the issue of double listing, except to note that geographic variations in organ availability are the driving force behind the double listing phenomenon. If a patient's chances of receiving an organ were the same regardless of where he or she was listed, no incentive to list at more than one transplant center would exist.
[FN40]. H.R. Rep. No. 769, 98th Cong., 2d Sess. 9 (1984).
[FN41]. NOTA, S 101(b)(3)(E), 98 Stat. 2338, at 2339. The 1988 Amendments by Congress deleted the reference to allocation among transplant "centers" so that the directive referred simply to allocation among transplant "patients." Organ Transplant Amendments Act of 1988 S 402(c)(1)(C), 102 Stat. 3114, 3115; see also 42 U.S.C. S 273(b)(3)(E) (1988). Congress stated that it wished to clarify that organs should be allocated equitably among patients, in the face of concerns over potential "favoritism to patients of a particular transplant facility." S. Rep. No. 310, 100th Cong., 2d Sess. 12 (1988), reprinted in 1988 U.S.C.C.A.N. 4167, 4240.
[FN42]. Organ Transplant Amendments Act of 1988, S 402(c)(1)(C)-(D), 102 Stat. at 3115; see also 42 U.S.C. S 273(b)(3)(E) (Supp. 1992).
[FN43]. Transplant Amendments Act of 1990, S 201(c)(1), 104 Stat. 3283, 3283; see also 42 U.S.C. S 273(b)(1)(E) (Supp. 1992).
[FN44]. 42 U.S.C. S 274(b)(2)(D) (Supp. 1993).
[FN45]. See Health Omnibus Programs Extension of 1988, S 403(a)(2), 102 Stat. 3048, 3048; Transplant Amendments Act of 1990, S 202(b)(1), 104 Stat. at 3279.
[FN46]. S. Rep. No. 310, 100th Cong., 2d Sess. 1 (1988), reprinted in 1988 U.S.C.C.A.N. 4167, 4241-42.
[FN47]. Principles and Objectives, supra note 2, at 1.
[FN48]. See 42 U.S.C. S 274(b)(2) (1988 & Supp. V 1993).
[FN49]. See Principles and Objectives, supra note 2, at 2, 14, 17.
[FN50]. Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 294 (3d ed. 1989) ("(I)n distributing scarce organs for transplantation, medical utility would require that the organs be used in the most effective and efficient way to maximize the welfare of patients suffering from end-stage organ failure."). Quality of life is used here in a strictly medical sense: freedom from pain, improved physical ability to go about daily activities without tiring rapidly, and so on. No judgment is made regarding the use to which patients ultimately put their improved health. For medical utility purposes, freedom from pain and improved physical ability count equally for either prince or pauper. Id. ("In judgments of medical utility, physicians and others try to maximize the welfare of patients, whereas in judgments of social utility, they try to maximize the welfare of society. . . . Judgments of medical utility are consistent with the equal social value of lives, whereas judgments of social utility may distinguish between the greater and lesser social worth of lives.").
[FN51]. Principles and Objectives, supra note 2, at 2 (defining "medical utility" as "net medical benefit to all transplant patients as a group").
[FN52]. Beauchamp & Childress, supra note 51, at 294.
[FN53]. Such costs are often borne by the Government through Medicare and Medicaid payments.
[FN54]. Many aspects of social utility are not relevant to a comparative analysis of organ allocation systems, given that such an analysis presumes the social value of organ transplants in general, as compared to other socially desirable activities that might trade off with transplantation. We thus do not need to compare the overall social utility of transplantation with the social utility, for example, of prenatal care; the only comparison is between competing allocation systems. Cf. Beauchamp & Childress, supra note 51, at 285- 86 (describing a 1987 Oregon Medicaid proposal "not to pay for most transplants in order to use their limited budget for other purposes" such as "regular prenatal care," which proponents claimed would save more lives); id. at 286 ("(I)t is not clear that under a decent-minimum (health care) rule justice requires society to provide funds to cover heart transplants (or any other massively expensive form of health care) under present circumstances.").
[FN55]. It is beyond dispute that the most basic medical utility requirements for a transplant (i.e., compatible size and blood type between donor and recipient) must be satisfied before questions of equity take on meaning. Likewise, it is equally beyond dispute that when no utility considerations are involved, equity concerns should govern allocation decisions (as opposed to allowing strictly arbitrary or intentionally invidious allocation decisions).
[FN56]. See, e.g., Peter A. Ubel et al., Rationing Failure: The Ethical Lessons of the Re-transplantation of Scarce Vital Organs, 270 JAMA 2469, 2473 (1993) (criticizing the lack of preference for first-time transplant candidates relative to retransplant candidates); Robert S. Gaston et al., Racial Equity in Renal Transplantation: The Disparate Impact of HLA-Based Allocation, 270 JAMA 1352, 1352 (1993) (criticizing the disparate racial impact of HLA matching in kidney allocation); Lisa Belkin, Fairness Debated in Quick Transplant, N.Y. Times, June 16, 1993, at A16 (discussing how the effective absence of a waiting list for multi-organ transplants allowed Pennsylvania Governor Robert P. Casey to receive a heart-liver transplant ahead of patients waiting for individual organs).
[FN57]. Principles and Objectives, supra note 2, at 15
[FN58]. Id. at 8.
[FN59]. This Article uses state-based availability rather than OPO-based availability because of UNOS's refusal to provide comprehensive OPO-based data from which organ availability could be derived. State data, however, is sufficient to illustrate the point regarding geographic variations.
[FN60]. United Network for Organ Sharing, The UNOS Statement of Principles and Objectives of Equitable Organ Allocation 24 (Draft for Comment 1993) (hereinafter Draft Principles and Objectives); Principles and Objectives, supra note 2, at 15. Indeed, the Notice of Proposed Rulemaking by HHS concerning the OPTN recognized the geographic disparities in patient waiting times by including data concerning the substantial variation in median waiting times for heart transplant candidates in different OPOs. See 59 Fed. Reg. 46,482, 46,486-87 (1994) (OPO median waiting times for heart transplants range from 55 days to 767 days).
[FN61]. Draft Principles and Objectives, supra note 60, at 24. Although the size of the patient waiting list certainly is relevant to waiting-time disparities, the size of the waiting list relative to the number of available organs is actually determinative. A waiting-list-to-donor ratio of 100:100 is obviously preferable to a ratio of 50:25, despite the shorter waiting list in the second example. Furthermore, balanced gross numbers of donors and recipients are not always enough: small waiting lists accessing small supplies of organs may still face problems due to a lack of sufficient diversity in the donor pool to match the particular patients awaiting transplant. Only once the pool of available organs has reached a critical size sufficient to generate a consistent flow of organs having each of the many possible combinations of blood type and size will it be possible to rationalize patient waiting times according to medical criteria.
[FN62]. 42 U.S.C. S 273(b)(1)(E) (1991).
[FN63]. Principles and Objectives, supra note 2, at 15.
[FN64]. Local patients at other transplant centers within the same OPO as centers of excellence likewise suffer longer waits due to the artificially bloated demand and the unchanged supply of organs within the OPO.
[FN65]. Principles and Objectives, supra note 2, at 15.
[FN66]. The VA has been looking for ways to reduce the strain on the local OPOs in which its regional transplant centers are located and is contracting for transplants with other centers affiliated with VA medical centers throughout the country. See letter from Dr. Pamela Steele, Acting Director, Medical Service, Veterans Health Administration, to Erik S. Jaffe, February 3, 1995. This approach is certainly reasonable given the constraints on supply, but unfortunately, it converts the medical decision of where to send a patient for transplant into a supply-driven decision of where such patients might have a reasonable opportunity to receive an organ, regardless of other medical or institutional concerns.
[FN67]. UNOS has stated that it has approved state-wide sharing arrangements because UNOS can do nothing about them insofar as UNOS policies are inferior to state laws that may authorize sharing arrangements. See Principles and Objectives, supra note 2, at 10. Although the legal merit of UNOS's claimed lack of authority remains open to question, UNOS policies are submitted to and approved by HHS, at which point they certainly would override any contrary state laws.
[FN68]. Even if state-wide lists supplant, rather than supplement, OPO-wide lists--that is, eliminate local distribution and require that the entire state serve as the first-order distribution area--the result would be improved equity within the state but no greater equity between patients in different states. Once a list grows sufficiently large and diverse to absorb all organs generated within the service area for that list --as would certainly be the case in many states--inter-area sharing will cease. Under such circumstances, lower status patients within a state will receive priority over higher status patients waiting in other states. At least when the local lists were smaller, a certain portion of donated organs would not be used locally and would be shared regionally or nationally. A limited increase in the size of the distribution pool eliminates this sort of sharing--an example of partial solutions being worse than no action at all.
[FN69]. Some doctors have suggested occasionally that transplanting healthier patients will improve overall success rates. See, Principles and Objectives, supra note 2, at 9 ("(P)atients who receive their transplant when they are very sick lose their graft more often than patients who receive transplants before they become critically ill."). While such claims certainly warrant consideration, this Article takes the position that regardless of what medical judgments and value decisions ultimately are made, the medical criteria must be applied uniformly.
[FN70]. One measure of the consequences of the supply and demand imbalance is the ratio of patients who die while waiting for a transplant to patients who actually receive a transplant. The higher the ratio, the greater the imbalance between supply and demand, and the greater the percentage of transplant candidates who die due to lack of available organs. For example, in 1993, the national average deaths-while-waiting ("DWW") per heart transplant was 0.33. State figures, however, varied from a high of 0.89 DWW per transplant to a low of 0.09 DWW per transplant, evidencing a significant geographic disparity in the risk of death while waiting for a heart transplant.
[FN71]. See Testerman, supra note 2, at 1A (discussing advocates of a "single national waiting list for organs"); Office of the Inspector General, HHS, The Distribution of Organs for Transplantation: Expectations and Practices 14 (March 1991) (hereinafter OIG Report) (discussing proponents of regional or national organ distribution).
[FN72]. 42 U.S.C. S 274(b)(2)(D) (Supp. 1990) (emphasis added). See also 1993 Transplant Hearings, supra note 11, at 40 (statement of Rep. Bilirakis) (discussing statutory language).
[FN73]. United Network for Organ Sharing, The National Procurement and Transplantation Network, The Feasibility of Allocating Organs on The Basis of a Single National List (1991) (hereinafter National List Report).
[FN74]. Id. at 4.
[FN77]. This system was originally proposed to UNOS on August 19, 1993, by Sentara Norfolk General Hospital and the Children's Hospital of The King's Daughters. The proposal was presented formally to the UNOS Thoracic Organ Transplantation Committee on January 26, 1994. The Thoracic Organ Transplantation Committee rejected the proposed distribution system on March 3, 1994, expressing some of the concerns addressed infra part IV.
[FN78]. As a potential addition to this system, UNOS could establish its own maximum travel distance for hearts based upon viability. (Using the estimate in UNOS's Draft Principles and Objectives, supra note 60, at 21 and 33, of 4 to 6 hours viability and 500 miles equals one hour flying time, the system-wide maximum travel distance would likely be 1500-2000 miles.) This would place an upper limit on the distance individual centers may go to claim an available heart, though it is anticipated that under the proposed distribution system many centers would set their maximums at less than the UNOS maximum because, beyond a certain point, the extra distance often would gain little advantage and would increase ischemia time. Balancing the waiting time, medical costs and benefits for travel distances below the UNOS maximum, however, would be left to doctor discretion on a patient-by-patient basis.
[FN79]. The proposed model does suggest two allocation changes: (1) hearts would be allocated to ABO identical recipients rather than to recipients who were only ABO compatible as in the present system and (2) waiting time would be determinative only between groups of candidates defined by standard deviations from average waiting time to transplant. Waiting time would not be dispositive within such groups.
[FN80]. See notes 93-98 and accompanying text.
[FN81]. The improved Status 1 waiting times under the national and super- regional models come at the expense of lengthened Status 2 waiting times. This shift in waiting time is as it should be insofar as Status 1 patients are in urgent need of transplant and have higher priority for hearts under current allocation criteria. If long Status 2 waiting times are a problem, the medical community should revisit the current allocation criteria, not try to circumvent such criteria through manipulation of the distribution system.
[FN82]. At least one study has suggested that patients waiting over six months in Status 2 are actually less likely to die than patients having waited less than six months. See Lynne Warner Stevenson et al., Decreasing Survival Benefit From Cardiac Transplantation for Outpatients as the Waiting List Lengthens, 18 J. Amer. Coll. Cardiology 919, 922 (1991) ("Because 75% of the deaths during 24 months after evaluation occurred within the 1st 6 months, the likelihood for survival without transplantation improved in outpatients who survived that initial 6 months."). For each individual patient, however, the longer he or she waits, the greater the chance that he or she will die, notwithstanding the fact that as a group those who survive for six months have a lower death rate than patients just placed on the list.
[FN83]. Principles and Objectives, supra note 2, at 6.
[FN84]. The debate over the medical utility of current UNOS allocation policies is irrelevant to the issue of whether medically rational policies, once they are established, should be uniformly applied. The proper response to irrational UNOS allocation policies is to change those policies, not to disregard them in an ad-hoc and inconsistent manner.
[FN85]. Compare Principles and Objectives, supra note 2, at 6 ("It is important for all transplant candidates as a group that the allocation policy try to achieve the best transplant survival rates possible. . . . (T)ransplanting patients whose condition has worsened to the point that their chances of survival have diminished will perpetuate the likelihood that patients who are not as sick and have a higher probability of a successful transplant will be forced to wait until their condition worsens and their chances for success are also diminished.") with id. at 13 ("A degree of priority should be given to patients whose conditions are most medically urgent . . . For example, for heart, liver, and lung candidates for whom there is no alternative form of therapy, those who are most likely to expire the soonest are considered to be in the most urgent need.").
[FN86]. See Principles and Objectives, supra note 2, at 14 ("A close immunological match with the donor can also result in longer graft survival.").
[FN87]. See Gerhard Opelz & Thomas Wujciak, The Influence of HLA Compatibility on Graft Survival After Heart Transplantation, 330 New Eng. J. Med. 816, 818 (1994). Although UNOS, in its study regarding the feasibility of a national list, has argued that HLA matching is too complicated given the ischemic time constraints even for kidneys, much of the difficulty identified in that study came from cross-matching and not from initial HLA matching. See National List Report, supra note 73, at 30. Cross-matching would not be used in the context of heart transplants.
[FN88]. Older Heart Donors May Pose Risk, UNOS Study Says, UNOS Update, May 1994, at 10.
[FN90]. If the increased donor pool was not sufficient by itself to generate a match, there are additional allocation-based steps to help hard-to-match patients. For example, the ABO identicality requirement could be relaxed for such patients to ABO compatibility, further increasing (except for type-O patients) the organ pool.
[FN91]. See Principles and Objectives, supra note 2, at 18 (listing "increased ischemia leading to organ wastage" as a "Conflicting Potential Result" of shifting to organ distribution via a national list).
[FN92]. National List Report, supra note 73, at 31.
[FN93]. UNOS's "regional" definitions for hearts, by contrast, are much more sensible but are marginalized by growing local lists and state-wide sharing arrangements. The first UNOS "region" for hearts--a 500-mile radius circle centered on the donor location--is related to cost and ischemic time in that it was chosen based upon the one-hour flight time for a jet airplane.
[FN94]. For example, a heart procured in northern Florida and medically compatible with a Status 2 patient in Miami and a Status 1 patient in Atlanta would be flown to Miami under the present system, notwithstanding the fact that it would be cheaper, faster, and medically appropriate to send that heart to Atlanta. Under the proposed model the heart would go to Atlanta before Miami, thus better serving every conceivable policy objective. Given that many transplant centers are located near state borders, this scenario is not unlikely.
[FN95]. The super-regional model also places an absolute maximum of 1500 miles on organ travel, thus avoiding organ wastage that might occur due to extremely long travel distances.
[FN96]. Draft Principles and Objectives, supra note 60, at 33.
[FN97]. Organ Allocation Forum Yields Variety of Opinions, UNOS Update, March 1994, at 3 (quoting Charles J. Hutson, liver recipient as saying that "any attempt to nationalize the waiting list of recipients would jeopardize the viability of many smaller, yet equally successful programs. These programs are important, keeping recipients close to home, family and the community support system."); id. (quoting Frank P. Stuart, M.D., President, American Society of Transplant Surgeons, as saying, "It is likely that national lists would benefit large transplant centers to the detriment of equally good, but smaller transplant centers scattered throughout the United States.").
[FN98]. Principles and Objectives, supra note 2, at 15 ("Some programs are inordinately large in comparison to the surrounding population and donor supply. This situation can result in a severe drain on the donor supply in adjacent areas."); id. (Military and VA referral systems and private "centers of excellence . . . tend to overload local Waiting Lists, making waiting times longer for other patients in the area.").
[FN99]. OIG Report, supra note 71, at 14 ("(A)mong many transplant professionals and transplant surgeons in particular, there remains a sense of ownership of donated organs they have retrieved. . . . (M)any transplant professionals, instead of viewing themselves as trustees of donated organs for all transplant candidates in the United States, regard themselves more as agents for patients associated with a particular transplant center or residing in a particular service area."); Beauchamp & Childress, supra note 50, at 293 (noting the issue of whether "donated organs (should) be given to patients in the communities where they were donated or given to patients in the national system . . . who most need and could most benefit from those particular organs," and observing that the Task Force on Organ Transplantation sided with the latter position).
[FN100]. Task Force, supra note 6, at xxi (emphasis added).
[FN101]. OIG Report, supra note 71, at 14.
[FN102]. See 59 Fed. Reg. 48,472, 48,488 (1994).
[FN103]. See supra Table 3.
[FN104]. The key element here is that patients can be relocated within a catchment area without creating an imbalance between supply and demand. Only when patients are relocated unequally between catchment areas does the possibility of dislocation exist.
[FN105]. Principles and Objectives, supra note 2, at 2.
[FN106]. See supra note 78.
[FN107]. OIG Report, supra note 71, at 15.
[FN110]. Draft Principles and Objectives, supra note 60, at 23, 31.
[FN111]. OIG Report, supra note 71, at 15-16 (emphasis added).
[FN112]. See Principles and Objectives, supra note 2, at 2; see also Beauchamp & Childress, supra note 50, at 296 (arguing that "public confidence that the criteria of allocation are morally acceptable and fairly applied is important for the maintenance of trust that is essential to organ donation").
END OF DOCUMENT
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