Secretary Of Health And Human Services Setting Organ Transplant List?
Ochsner J. 1999 Jan; one(1): half-dozen–11.
The Organ Allocation Controversy: How Did We Arrive Here?
Clifford H. Van Meter
Master of the Segmentation of Cardiothoracic Surgery and Transplantation, Ochsner Clinic and Alton Ochsner Medical Foundation; Chairman of the United Network for Organ Sharing, Thoracic Organs Commission; President of the Board of the Louisiana Organ Procurement Agency
Abstract
The Department of Health and Human Services (HHS) recently issued a final regulation governing the Organ Procurement and Transplantation Network (OPTN) that directs the allotment of organs to the sickest patients first without regard to a host of medical, geographic, and social factors that members of the transplant customs view as an essential function of a sound organ resource allotment policy.
Current organ allocation mechanisms are based on policies that reflect a broad consensus of medical experts and provide equal consideration for both the needs of the sickest patients and the efficient use of organs. This system also reduces potential waste product of organs by minimizing cold ischemic time, increases access to transplantation for patients in local communities, provides positive incentives for local citizens and medical professionals to support organ donation initiatives, and decreases the toll of organ transplantation.
Representatives of the American Society of Transplant Surgeons have testified before Congress that "giving priority to the sickest patients first over broad geographic areas would be wasteful and dangerous, resulting in fewer patients transplanted, increased death rates, increased retransplantation due to poor organ role, and increased overall cost of transplantation." In response, Congress enacted a ane-year moratorium on the implementation of the HHS dominion and provided for a study of the current organ allocation policy and HHS regulation past The Institute of Medicine.
Introduction
Since the first successful evolution of kidney transplants in the mid-1950s, organ transplantation in the United States has undergone a legislative and regulatory metamorphosis (1). Until the tardily 1960s, organ transplantation existed without government involvement. Transplantation was predominantly a local endeavor consisting of a transplant surgeon, his or her team, and some grade of organ procurement system. Hospitals shared organs on an informal, voluntary basis (2). Just as the number of organ transplants began to increase exponentially and every bit Medicare and Medicaid began paying for many of these procedures, the involvement of the federal government kept pace. Today we accept a formal national infrastructure with governmental and quasi-governmental oversight.
On April 2, 1998, the Section of Wellness and Human being Services (HHS) issued a final regulation governing the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS) requiring the implementation of new organ allocation policies. The dominion contains a controversial provision that directs the allotment of organs to the sickest patients without regard to geographic considerations and a host of medical and social factors that have long been viewed by members of the transplant community as an essential part of the development of audio organ allocation policy. A decade of progress toward increasing the supply of donated organs and expanding admission for patients to organ transplantation is threatened by the policy. The ultimate disposition of these regulations could decide the future of organ transplantation in the United States.
Legislative History and Cosmos of the Organ Procurement and Transplantation Network
The legislative and regulatory foundations of organ donation and transplantation began with the enactment of the Uniform Anatomical Souvenir Deed of 1968 (Table i). When Congress passed the National Organ Transplant Deed in 1984, it recognized that a national organ allocation system would require the careful practice of medical judgment coupled with the voluntary back up and participation of the transplant community. Thus, Congress created the OPTN, an organization exterior of government, self-governed by the transplant community, and charged with the responsibility for making difficult decisions concerning allocation of a scarce and precious resource—human organs for transplantation. The Secretary of HHS was directed to contract with a private, non-profit entity to establish and guide the OPTN. UNOS was awarded the original contract and has connected to operate the OPTN since 1986.
Table 1.
Chronology of Legislation and Regulation
The members of UNOS include patients; transplant recipients; donor family members; representatives of voluntary wellness, medical, and scientific organizations (such every bit the American Heart Clan, National Kidney Foundation, American Medical Association, etc.); and every transplant center, organ procurement agency, and tissue typing laboratory in the U.s.. UNOS is governed by representatives of the transplant community, including surgeons, physicians, and professionals from organ procurement agencies, who are elected past their peers from transplant regions around the country to committees charged with developing and codifying organ allocation policy. Among their responsibilities are setting and maintaining professional standards for participation in all transplant organizations, standardizing medical criteria for listing, measuring the medical status of patients awaiting organ transplantation, and adjusting organ allocation policies to optimize benefits to potential recipients.
The dissemination of medical adequacy and expansion of public and professional education concerning organ donation have increased the availability of multi-organ transplant services for all Americans. Recent years accept seen not only the development of techniques and technologies to foster transplant capabilities, such equally lung and pancreas transplantation, split-liver transplantation, and mechanical bridges to cardiac transplantation, merely as well the expansion of UNOS-approved transplant centers serving patients in all regions of the country.
The Growing Need for Donor Organs
Unfortunately, the disparity betwixt the number of patients who crave organ transplantation and the number of donor organs continues to abound (Figure 1). "Since 1988, the organ transplant waiting list has quadrupled with virtually 61,000 men, women, and children waiting for a transplant today" (3). The number of organ donors, however, has grown at a much less rapid pace, providing roughly 20,000 organs for transplantation in 1997 (4). As a result, the American Guild of Transplant Surgeons has stated that the master goals of public policy should be to expand and enhance organ donation, and ensure "that the precious organs shortly available provide the maximum benefit to the maximum number of Americans in an equitable way." (5)
Comparison of donors versus number of waiting patients (iv).
Electric current Methods of Organ Allocation
For UNOS members, the challenges associated with the development of organ allotment policy are often described equally a struggle to provide residuum and equal consideration of factors related to utility and justice. The principle of utility "suggests that when the demand for transplantable organs exceeds supply, the organs should be allocated to patients who take the best gamble of benefiting from a transplant. The principle of justice, which insists that the benefits and burdens of the [organ allocation] system exist shared amid all patients equitably, would favor the patient who had the well-nigh urgent demand or has waited the longest" for a transplant (4).
Organ allocation policies must also be crafted to reflect specific medical factors, such every bit the limited viability of donor organs in the absence of oxygenated claret. Maximum cold ischemic times vary by the blazon of organ. Hearts must be transplanted inside approximately four hours and livers retain viability for approximately 12 hours, with maximum cold ischemic time influenced by the status of the donor organ.
Increases in cold ischemic time raise the probability that an organ will non part later on transplantation. In addition, allocation policies should weigh the fact that the near severely sick patients awaiting transplantation take lower survival rates and an increased demand for a 2d organ transplant when compared with the entire population of transplant patients. Finally, certain patient groups crave special medical consideration, including children and patients with highly sensitized immune systems.
UNOS has addressed this situation through development of an organ allocation policy based on a broad consensus of experts in the transplant community, hit a balance between the many competing objectives surrounding the concepts of justice and utility. Organs are offset allocated to patients within the boundaries of the local organ procurement system (OPO) (which in Louisiana encompasses the entire state), then to patients in the face-to-face region, then to patients nationally. Organs are offered first to the sickest patients in a local OPO expanse, and then to patients in the aforementioned surface area with less medically urgent conditions if a patient with an urgent medical demand is not available. If there are no suitable patients in a local OPO community, this same allotment procedure is replicated at the regional and then national level. (Annotation: There is a different allocation system for kidneys that addresses special problems involving the medical compatibility of patients and donor organs.) Within each status group, patient priority is determined on the footing of numerous factors, including blood type and time on the waiting list.
This arrangement provides equal consideration for both the needs of the sickest patients (Justice) and the efficient use of organs (Utility) "by permitting transplantation of some less urgent patients who accept a higher probability of surviving the longest and not needing a 2nd transplant (further depleting the already scarce resource)." (6) A balanced approach to organ allocation results in high overall survival rates, and as well distributes "the benefits and burdens of organ transplantation among patients throughout the state with the most urgent" and severe medical atmospheric condition (four). This allocation mechanism also reduces potential waste of donated organs by minimizing cold ischemic fourth dimension; increases access to transplantation for patients in local communities, many of whom are from minority and economically disadvantaged populations; provides positive incentives for local citizens and medical professionals to support organ donation initiatives; and decreases the costs of organ transplantation owing to medical complications, the need for hospital care, and transportation and procurement costs.
The HHS Last Dominion
The HHS regulation contains a sweeping organ resource allotment policy that overrides the established OPTN system and replaces it with a mechanism that allocates organs to the sickest patients commencement without regard to geographic location. More than specifically, the HHS rule creates a policy "to classify organs among transplant candidates in gild of decreasing medical urgency condition, with waiting fourth dimension in status used to break ties within status groups. Neither place of residence nor place of list shall exist a major determinant of access to a transplant" (7). Patients who demand liver transplants will exist the starting time individuals affected by the new policy.
The main justification for the policy is an inaccurate assertion that the sickest patients are treated unfairly by the current allotment system and suffer from broad disparities in waiting times (8). HHS officials claim that the rule will equalize waiting times, thus creating a fairer allocation system. The final rule also acknowledges, withal, that "current measures of waiting fourth dimension disparities are weak because the lack of listing standards does non create uniform, status-related measures …" (ix). Farther, the regulation concedes that these policies will lead to lower survival rates, fewer patients transplanted, and longer time on the waiting list for about patients (10). The terminal rule too states that "the Secretary has concluding authority over OPTN policies and procedures" (xi) and that, "If the Secretary objects to a policy, the OPTN may be directed to revise the policy consistent with the Secretarial assistant'south direction." (12)
Public Comments and Analysis of the HHS Dominion
The new regulation has been met with widespread dismay and opposition past members of the transplant community. 1 major point of contention involves whether the regulation creates a new organ resource allotment system. Officials of HHS describe the regulation equally establishing wide "performance goals" to be achieved through policies developed by the OPTN. Representatives of UNOS have stated that the "policies, every bit expressed in this regulation include specific elements of what we interpreted as a required new organ allocation policy-including the exact criteria by which organs are to be allocated. Relieved of the allotment policy-making duties, the OPTN's remaining task … is that of developing detailed procedures for implementing the Secretary's policy." (13)
The specific directives of the regulation have also generated enormous concern because the policy is medically unbalanced. "When asked during a national briefing call … whether the new policy would yield the greatest benefit for the greatest number of patients," HHS officials "admitted that the new rule favors equity over utility" (fourteen). In response, Dr. Ronald Busuttil, President-elect of the American Guild of Transplant Surgeons and Main of the Division of Liver and Pancreas Transplantation at the Academy of California at Los Angeles School of Medicine, testified earlier Congress that "giving priority to sickest beginning over broad geographic areas would be wasteful and unsafe, resulting in fewer patients transplanted, increased death rates, increased retransplantation due to poor organ function, and increased overall cost of transplantation." He too stated that "the rationale for rushing this rule into effect may largely have disappeared." Since the implementation past UNOS of standardized medical criteria for listing an [Text is not Clear] the medical status of patients, "data for 1998 through the month of Baronial" signal "that for status-one patients, the most critically ill, the mean waiting time for a [liver]transplant-beyond the country – now is running 4 days, with non a corking deal of regional variation" (15).
In addition, UNOS and many observers have expressed neat business concern that implementation of the HHS dominion would result in the allotment of organs to a small group of big transplant centers, reducing admission to transplantation for patients in local communities, particularly for Medicaid and economically disadvantaged recipients who cannot beget to seek their intendance at medical centers in distant locations. This policy would besides undermine local communities that have been peculiarly successful in their efforts to stimulate organ donation, declining to account for the linkage between increased organ donation and decreased patient waiting times within OPO service areas. On a broader level, the rule does not assess the wide disparities in OPO performance and how these variations influence patient waiting times in specific regions of the state.
Transplant surgeons fear that new surgical techniques, such equally the split liver process, where 1 organ is divided and used to serve 2 patients, would exist impaired by the regulation considering the success of the procedure is dependent upon minimizing cold ischemic fourth dimension. "Full utilization of this split-liver procedure would potentially increment available donor livers by shut to 1,000 per year in the U.S." (15).
From a quantitative perspective, "data generated by a national console of experts" (xvi), led past Alan Pritsker, PhD and UNOS staff scientists, "predict the post-obit: … over a vii-year period, 1,508 fewer patients [will] be transplanted" (4, sixteen) (Figure 2), the survival charge per unit for the entire patient population will fall by 9.3% (Figure 3) (4), and patients volition have to wait much longer for a transplant (Effigy 4) (4), with many individuals throughout the country experiencing a substantial increase in waiting time for a liver transplant of between 51 and 86 days (Effigy 5) (17). "Further, the model did not assume whatsoever increased organ wastage despite the fact that" (13) the median distance for transportation of donor organs to recipients volition increase from 71 miles to 930 miles (Figure 6) (four). The regulation also suggests that the percentage of organs donated and provided to patients in local OPO areas may drib from approximately lxxx% to 20% (eighteen), "a fact that could exist tremendously damaging to local organ donation efforts" (16).
Comparison of liver allocation policies: patients transplanted 1997-2003. Approximately 4,000 transplants are done each year (4).
Comparison of liver allocation policies: patients survival rates (4).
Comparison of liver allocation policies: projected waiting time for liver transplants (4).
Projected modify in patient waiting times for liver transplantation under HHS policy.
Comparing of liver allocation policies: transportation of organs and doctors, median miles per transplant.
Legislative and Legal Responses
In response to the HHS rule, Congress intervened in the regulatory procedure by enacting legislation to extend the effective date of the regulation from July 1, 1998 to October 1, 1998, and conducted hearings to review the impact of the HHS policy. Both the American Society of Transplant Surgeons and UNOS chosen on members of Congress to cake the implementation of the HHS rule in hearings held on September ten, 1998. The President-elect of the American Social club of Transplant Surgeons testified that, "the Section in subsequent discussions with our society has told the states that in fact, giving priority to sickest patients start-in effect, creating a national waiting list-is non the intent of the rule. Nevertheless, they [HHS] have not changed the rule to make information technology articulate that information technology would not require transporting organs beyond broad geographic regions." The regulation "equally information technology now stands, would damage a system which we have tried to make equally off-white as humanly possible" and "permit substitution of the Secretarial assistant's judgment on organ allocation for the judgment of medical professionals. We do not believe this is what was intended by Congress when information technology enacted the National Organ Transplant Human activity" (15).
In late September, the State of Louisiana, led by Attorney General Richard Ieyoub, the Louisiana Organ Procurement Agency, and Louisiana transplant centers, filed a lawsuit in a Billy Rouge Federal Court challenging the new HHS organ resource allotment scheme. Gauge Ralph Tyson issued a stay society enjoining HHS from enforcing the terminal rule until the legal challenge is resolved.
Finally, as office of the wide agreement on the federal budget crafted in October of 1998, members of Congress, lead by Representative Bob Livingston, and officials of the Clinton Administration agreed to a 1-yr moratorium on the implementation of the HHS dominion. The legislation also provides for a study of the current organ allocation policies and the HHS regulation, to be conducted past The Plant of Medicine, and mechanisms for future discussions between UNOS and HHS officials (19).
Conclusions
The organ resource allotment controversy will be addressed in the coming twelvemonth by the Found of Medicine, representatives of HHS and the transplant community, members of Congress, and, perhaps, the Federal Courts. In the end, we must hope for iii positive developments: commencement, that the public never be concerned or led to believe that organ resource allotment policy is annihilation less than the all-time that can exist achieved; second, that organ allocation policy remains in the hands of the transplant medical customs under the appropriate oversight of federal agencies; finally, that the full focus and effort of all parties be redirected toward the goal of enhanced public and professional person pedagogy leading to increased organ donation.
References
1. Murray JE, Merrill JP, Harrison JH. Kidney transplantation between seven pairs of identical twins. Ann Surg. 1958;148 [PMC free article] [PubMed] [Google Scholar]
2. Prottas J. The Most Useful Gift: Altruism and the Public Policy of Organ Transplants, San Francisco: Jossey, Bass,; 1994. [Google Scholar]
iii. Testimony of Dr. William West. Pfaff before the Senate Appropriations Committee, Labor, Health and Human Service, Education Subcommittee, September x, 1998. p. one.
iv. United Network for Organ Sharing, Congressional Staff Conference: Affect of HHS OPTN Regulations. May 1, 1998.
5. American Society of Transplant Surgeons: Position newspaper on the Department of Health and Human Services Rule on the Organ Procurement and Transplantation Network, June 1, 1998. p. ane.
6. United Network for Organ Sharing. The UNOS Statement of Principles and Objectives of Equitable Organ Resource allotment. June 29, 1994. p. 165.
seven. Federal Register. Rules and Regulations. 1998;63(63):16335. [Google Scholar]
8. Federal Register. Rules and Regulations. 1998;63(63):16298. [Google Scholar]
ix. Federal Register. Rules and Regulations. 1998;63(63):16327. [Google Scholar]
10. Federal Register. Rules and Regulations. 1998;63(63):16325. [Google Scholar]
xi. Federal Register. Rules and Regulations. 1998;63(63):16299. [Google Scholar]
12. Federal Register. Rules and Regulations. 1998;63(63):16334. [Google Scholar]
xiii. Response to HHS Concerns about UNOS Statements Regarding the Regulations. May. 1998. www.unos.org.
14. The Patient Access Coalition. Comments on the Department of Health and Homo Services' April 2, 1998 Concluding Rule Regarding the Organ Procurement and Transplantation Network, August 28, 1998.
15. Argument of Ronald W. Busuttil, MD, Ph.D., FACS, before the hearing of the Subcommittee on Labor, Wellness and Human Services and Didactics of the Senate Appropriations Committee, September ten, 1998.
xvi. Sollinger H, Physician. Transplants: Who should get them commencement; how to heighten donation rates. June eighteen, 1998. p. 1.
17. Federal Annals. Rules and Regulations. 1998;63(63):16327. [Google Scholar]
18. Federal Annals. Rules and Regulations. 1998;63(63):16324. [Google Scholar]
19. Conference Report 105-825 to back-trail H.R. 4328. "Making Omnibus Consolidated and Emergency Supplemental Appropriations for Fiscal Twelvemonth 1999"
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Secretary Of Health And Human Services Setting Organ Transplant List?,
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3145429/
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