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Organ Allocation

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NOTE: This report represents information on this subject as of December 1999.

Substitute Resolution 505 (A-98) on organ transplants, referred to the Board of Trustees for decision, asked that the: "American Medical Association (AMA)  commend the United Network of Organ Sharing (UNOS) for the tremendous progress it has made in organ transplantation; and urge the US Department of Health and Human Services (DHHS) and UNOS to work together in order to correct the disparities in the present system of organ distribution and allocation; and support the original intent of National Organ Transplant Act (NOTA) which gave DHHS oversight responsibility and gave the primary responsibility to the transplant community including the organ transplant professionals for developing policy; and promote greater professional and public awareness of the urgent need for increased organ donation."

Resolution 522, introduced by the Organized Medical Staff Section at the 1998 Interim Meeting and referred to the Board of Trustees, asks:

That our AMA Policy H-370.990 (AMA Policy Compendium), "Transplantable Organs as a National Resource," be amended to state that organs and tissues retrieved for transplantation be treated as a resource for local, then regional and finally, national distribution.

Organ Procurement and Allocation

The current system for organ procurement and allocation is based on the National Organ Transplant Act (NOTA) passed in 1984. This statute includes the following provisions: (1) The Secretary of the DHHS should represent the public interest by setting broad goals for the Organ Procurement and Transplantation Network (OPTN) and by overseeing OPTN policy development and operation, with a view toward ensuring that the goals are being addressed reasonably; (2) organs should be equitably allocated to all patients.....in accordance with sound medical judgment;   and (3) the OPTN must exercise leadership in performing its responsibilities under NOTA.

UNOS, a voluntary organization, was awarded the contract to operate OPTN, and has done so since 1987. UNOS comprises all transplant hospitals, organ procurement organizations, histocompatibility laboratories, and importantly, transplant candidates and donor family members. A 1986 amendment to the Social Security Act made membership in OPTN and compliance with approved policies mandatory for Medicare-participating hospitals and organ procurement organizations. However, none of the OPTN/UNOS policies have been formally approved by the DHHS. Although these technically remain voluntary guidances, UNOS has reported noncompliance to the DHHS.

In April 1998, the DHHS issued a proposed final rule: Organ Procurement and Transplantation Network (42 CFR Part 121)[Docket No. 98-HRSA-01]. This proposed final rule allowed for a comment period and stated, in part, that the role of the Secretary of Health and Human Services is "working in partnership with the transplant community, [and] the Secretary has final authority over OPTN policies and procedures." This appears to run counter to the legislative intent of NOTA in which Congress authorized the DHHS to assume an auditing, as opposed to a preauthorization role over OPTN policies.

The focus of the proposed final rule is the liver allocation system, which currently allocates cadaveric livers on the basis of most urgent medical status at the level of local organ procurement organizations (OPO), followed by allocation to less urgent patients, again at the local OPO level. If the organ is not allocated at the local OPO level, it is then offered to the regional OPTN on the same basis, the most medically urgent patients first. Some regions have up to 12 local OPOs contained within the region (for example, Region 3 includes the states of Arkansas, Louisiana, Mississippi, Alabama, Georgia, and Florida). Thus, within the confines of the current system, it is possible for a liver to be allocated to a less critically ill patient within a local OPO when there are other more critically ill patients outside the local OPO but within a geographic radius of potential delivery based on the cold ischemic times for liver viability. The proposed final rule attempts to remedy this apparent discrepancy by specifying "[t]o allocate organs& in order of decreasing medical status& [n]either place of residence nor place of listing shall be a major determinant of access to a transplant." This specification effectively treats organs as a national resource. The UNOS position, which was supported by testimony at the 1998 AMA Annual Meeting, holds that the proposed final rule interjects the government inappropriately into the patient-physician relationship.

Current AMA Policy Related to Organ Transplantation [Editor's Note:  The following discussion reflects AMA policy at the time this report was written (Fall 1999).]

The AMA supports the concept that organs should be considered a national, rather than a regional resource and opposes any legislation, regulations, protocol, or policies directing or allowing governmental agencies to favor residents of a particular geopolitical jurisdiction as recipients of transplantable organs or tissue (Policy H-370.990). 

Additionally, the AMA recognizes that decisions regarding the allocation of organs should consider only ethically appropriate criteria relating to medical need. These criteria for organ allocation include: "(1) The likelihood of benefit to the patient; (2) the impact of treatment in improving the quality of the patient s life; (3) the duration of benefits; (4) the urgency of the patient s condition; and (5) in some cases, the amount of resources required for successful treatment (H-370.982). Decision-making mechanisms should be objective, flexible, and consistent to ensure that all patients are treated equally (H-370.982). 

The AMA has consistently advocated for working with UNOS, both to evaluate delivery system factors that impact graft and patient survival in transplantation (H-370.987), and in implementing UNOS's recommendations (H-370.983). Finally, the AMA has long advocated efforts and measures to enhance the rate of organ donation (H-370.980, H-370.986, H-370.995, H-370.996, H-370.998).

Further AMA Activities 

Following referral of Substitute Resolution 505 to the Board of Trustees, the AMA initiated two meetings with the DHHS, which took place during July 1998. Two representatives from the Council on Scientific Affairs (Myron Genel, MD, and Michael A. Williams, MD) attended the first of these meetings. Dr. Genel offered a unique perspective based on his experience as a Robert Wood Johnson Health Policy Fellow in then-Congressman Albert Gore's office at the time of Mr. Gore's involvement in the drafting of NOTA in 1984. Dr. Williams currently serves as the AMA's representative to Region 2 of UNOS. At these meetings, the DHHS helpfully and candidly explained the basis for its perspective contained in the proposed final rule and informed the AMA of continuing constructive dialogues with UNOS that had transpired since the Annual Meeting of the AMA HOD in June 1998. These discussions with the DHHS informed the content of the AMA's written comments on the proposal. 

The AMA commented on the proposed final rule in a letter dated September 4, 1998. In this letter the AMA: (1) Urged the DHHS and UNOS to work together; (2) recognized the oversight role of the DHHS and sought clarification of the scope of its auditing responsibility; (3) commended UNOS and acknowledged its responsibility, along with the transplant community, to develop new policies ensuring equitable organ allocation; and (4) pledged to work to increase organ donation. The Institute of Medicine (IOM) report on organ procurement and transplantation 1   (see Appendix) supports the position the AMA took in this letter. In addition, the language of the IOM report provides an opportunity for the DHHS and UNOS to move forward, abandoning polarized positions, to improve a system that was found to be essentially fair. 

In June 1999, AMA representatives, Drs. Yank Coble, Reed V. Tuckson, Thomas Houston, Michael A. Williams, and M. Priscilla Short, and AMA's counsel for federal affairs, Margaret Garikes, JD, met with the senior management of UNOS to reach better understanding of UNOS s position in the controversy between UNOS and DHHS. These discussions were notable for their constructive frankness and contributed to the AMA's greater appreciation for the complexities of the issues.

Institute of Medicine Report

Subsequent to the AMA's discussions with the DHHS, the implementation of the proposed final rule was delayed by congressional action until October 1999. Congress asked the IOM to study the proposed final rule's possible ramifications on organ donation rates, equitable access to transplantation, and costs. The IOM issued its report on July 20, 1999.1 The focus of the IOM was primarily on liver allocation, which was at the center of the controversy that the proposed final rule had engendered. 

The IOM   found that variation in waiting times across geographical regions was a poor marker of the fairness of the allocation system. The variability of waiting times across regions had been at the center of the DHHS s argument about inequities in the allocation system. The IOM report found that those with the greatest medical need (status 1) wait a "comparable period of time at sites all around the country." The IOM found the current system to be "reasonably effective and equitable." It recommends a new organ allocation policy that greatly enlarges the areas in which organs are allocated to areas consisting of more than 9 million in population through sharing arrangements with smaller OPOs. In June 1999, UNOS approved a new policy that allocates livers to the most urgent patients (status 1) on a regional basis, which is consistent with the IOM recommendation. Most current UNOS regions have populations ranging from 10 to 40 million. 

The IOM found that the poor and minorities have less access to organ transplantation. However, it was not a factor of the transplantation system; indeed, once in the transplantation network minorities received livers in an equitable fashion. The problem arises from the limited access that the poor and minorities have to basic health and medical care, which are issues beyond the scope of the transplantation community. 

The IOM report, in concluding that the system is "reasonably effective and equitable," also noted that it does so "without effective supervision and oversight." The IOM felt that oversight and review should focus on "assuring that the system is equitable, is grounded on sound medical science, and always places highest priority on the needs of the patients it serves. It is not the purpose of such oversight to micromanage day-to-day care." Recommendations 3 and 4 of the IOM report expand on clarification of appropriate federal oversight and the need for an "independent, multidisciplinary, scientific review board responsible for assisting the DHHS Secretary in ensuring that the allocation system of the OPTN is grounded on the best available medical science and is as effective and as equitable as possible." The IOM report corroborates the UNOS conclusion that the proposed final rule would increase the overall costs of organ transplantation, although it gave no cost estimates. 

Finally, with regard to access to data, the IOM report acknowledges that "UNOS currently collects, analyzes, and disseminates more data than are available for most other medical procedures." Furthermore, the IOM report stated that many felt the data should be available on a more timely basis, and independent review and analysis would be helpful. UNOS recently announced it will publish more data for patients about the performance of individual transplant centers (data up to 1988 is currently available to the public) so that the "information published for the public and patient will be as timely as it can be."

Conclusions

The AMA recognizes that the just allocation of organs is an exquisitely complex process and that disparities continue to exist in organ availability across geographic regions. The requirement in the proposed final rule for elimination of geographical boundaries is consistent with AMA policy. Some of the controversy in the proposed final rule relates to the need for clarification of the DHHS intent concerning the extent of OPTN oversight. The AMA supports an oversight role of the DHHS that is intended to foster equitable access to organs. The AMA further believes that ethical consensus in concert with proper medical practice, as established by the professional transplant community, should underpin any changes in allocation policy. To this end, it is reasonable that a rigorous evaluation of the current technologies used in organ procurement and transplantation be used to support any significant change in the current organ transplantation policy. The Council believes that the AMA should endorse the creation of an "independent, multidisciplinary, scientific review board responsible for assisting the DHHS Secretary in ensuring that the allocation system of the OPTN is grounded on the best available medical science and is as effective and as equitable as possible" as recommended by the Institute of Medicine. Finally, it can not be over emphasized that increased organ donation is the most critical component in achieving an equitable allocation strategy. Physicians can be effective advocates for encouraging their families, staff, and patients to become organ donors.

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 1999 AMA Interim Meeting.

  1. The AMA supports the United Network of Organ Sharing (UNOS) policy calling for regional allocation of livers to status 1 (most urgent medical need) patients as an effort to more equitably distribute a scarce resource;  
  2. The AMA supports the findings and recommendations of the Institute of Medicine Committee on Organ Procurement and Transplantation Policy; and  
  3. The AMA will monitor the outcome of the proposed final rule: "Organ Procurement and Transplantation" issued by the Department of Health and Human Services and respondas appropriate.  
  4. Policies H-370.990, H-370.982, and H-370.983 are reaffirmed. 

Reference

  1. Institute of Medicine Committee on Organ Procurement and Transplantation Policy. Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule. Washington, DC: National Academy Press; July 1999.

Appendix

Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule

Committee on Organ Procurement and Transplantation Policy

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

RECOMMENDATION 1: Establish organ allocation areas for livers: The committee recommends that the Department of Health and Human Services (DHHS) Final Rule be implemented by the establishment of Organ Allocation Areas (OAAs) for livers¾ each serving a population base of at least 9 million people (unless such an area would exceed the limits of acceptable cold ischemic time). OAAs should generally be established through sharing arrangements among organ procurement organizations to avoid disrupting effective current procurement activities.

RECOMMENDATION 2: Discontinue use of waiting time as an allocation criterion for patients in statuses 2B and 3: The heterogeneity and wide range of severity of illness in statuses 2B and 3 make waiting time relatively misleading within these categories. For this reason, waiting time should be discontinued as an allocation criterion for status 2B and 3 patients. An appropriate medical triage system should be developed to ensure equitable allocation of organs to patients in these categories. Such a system may, for example, be based on a point system arising out of medical characteristics and disease prognoses rather than waiting times. 

RECOMMENDATION 3: Exercise federal oversight: The DHHS should exercise the legitimate oversight responsibilities assigned to it by the National Organ Transplant Act, and articulated in the Final Rule, to manage the system of organ procurement and transplantation in the public interest. This oversight should include greater use of patient-centered, outcome-oriented performance measures for OPOs, transplant centers, and the Organ Procurement and Transplantation Network (OPTN).

RECOMMENDATION 4: Establish independent scientific review.   The DHHS should establish an external, independent, multidisciplinary scientific review board responsible for assisting the Secretary in ensuring that the system of organ procurement and transplantation is grounded on the best available medical science and is as effective and as equitable as possible.

RECOMMENDATION 5: Improve data collection and dissemination.   Within the bounds of donor and recipient confidentiality and sound medical judgment, the OPTN contractor should improve its collection of standardized and useful data regarding the system of organ procurement and transplantation and make it widely available to independent investigators and scientific reviewers in a timely manner. The DHHS should provide an independent, objective assessment of the quality and effectiveness of the data that are collected and how they are analyzed and disseminated by the OPTN. Back to Text

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