Welcome and Charge to Committee
Nancy Ascher, M.D., Ph.D., Chair of ACOT
Jack Kress, Executive Director, ACOT

Dr. Ascher thanked the members of the Advisory Committee on Organ Transplantation (ACOT), and especially the subcommittee chairs, for their commitment to and diligence in committee work. Mr. Kress added that, while the committee's first meeting was primarily organizational, the current meeting would focus on reviewing progress toward the committee's goals so that, by its third meeting, ACOT could make formal recommendations to the Secretary of Health and Human Services.

The committee's consensus views have already been noted, reported, and acted on. For example, as a result of the committee's suggestions on donor recognition, the Health Resources and Services Administration (HRSA) is soliciting proposals to survey public opinion on compensation for donors.

Since ACOT's first meeting in December 2001, Dr. Ascher and Mr. Kress formed eight subcommittees based on a survey of ACOT members. The subcommittees have held teleconferences and obtained data from the Scientific Registry of Transplant Recipients (SRTR).

Secretary's Initiative

Update
Camille Haney, Special Assistant to the Secretary

Ms. Haney brought greetings from Secretary Tommy Thompson to the committee. She stated that the Secretary is a true champion of the work of this committee and wants to thank its members for giving their valuable time to this important issue. He finds the status quo unacceptable and urged ACOT members to share their ideas and increase public attention to organ donation and transplantation.

Recent accomplishments of the Secretary's Gift of Life Donation Initiative include:

• The Department held a registries conference and has initiated several pilot programs on local registries.
• An expert panel has examined all of the organ donation curricula in the country and will develop curricula that can be used in any class, including driver's education. The curricula will also be distributed to every medical school in the country.
• More than 1,000 organizations have joined the Workplace Initiative for Life and the goal for next year is to increase the total to 5,000.
• The Secretary is appearing in videotapes to promote the Initiative.
• The Initiative's Web site, organdonor.gov, is being completely reconstructed.

A social marketing campaign is targeting those who are undecided about organ donation by emphasizing that organ donation can save the lives of recipients, improve their quality of life, and help many people. Young people are learning that this is not just an issue for older people, because many young people also need organs.

Within the Department of Health and Human Services (DHHS), an attempt is being made to increase interagency collaboration. For example, the Secretary met with the leaders of older American groups, including AARP with its 35 million members, during Older Americans Month in May 2002. These groups pledged to work with the Secretary to dispel the myth that older Americans cannot donate their organs and to encourage seniors to pledge to donate and to persuade their families and the organizations they volunteer with to become involved. As a result of this meeting, the Administration on Aging is working with HRSA to promote organ donation by older Americans.

The Secretary is also working with other Federal departments. For example, the Office of Personnel Management has agreed to indicate Federal employees' organ donor status on their identification cards as part of an attempt to sign up the entire Federal workforce. Other groups that are helping recruit their members for the Gift of Life Donation Initiative include associations of government leaders, professional societies, faith-based organizations, labor unions, and the transplant community.

Regional Activity
Gary Gurian, Secretary's Regional Representative, Region III

The 10 Secretary's Regional Representatives (SRRs) across the country work with State and local governments and other stakeholders to facilitate the resolution of HHS issues and concerns, and promote and facilitate the policy initiatives of the Secretary and the President. The SRRs are helping to expand Americans' awareness of the importance of designating themselves formally as organ/tissue donors. Most of the SRRs have worked with their respective organ procurement organizations (OPOs) and State and local government officials to organize organ and tissue donor awareness events for targeted groups, such as Federal employees. Several SRRs have been recruiting businesses and business leaders in their regions to join the Workplace Partnership for Life. Mr. Gurian is also working with HRSA grantees in his region to promote organ donation among their clients.

Workplace Partnership for Life
Sue Bell, To Save a Life Coalition, Hadassah

Hadassah is the largest women's organization and the largest Zionist organization in the world. Hadassah has launched a national education project to help increase organ, tissue, and bone marrow donations. The San Antonio chapter recently began its own citywide campaign to enroll 10,000 new members by dispelling religious and cultural myths and other misinformation surrounding organ and tissue donation. In San Antonio alone, more than 1,500 patients are on the waiting list, but only 105 individuals donated organs in 2001.

The rabbi of the largest Jewish congregation in San Antonio wrote a religious proclamation that was signed by 13 prominent clergy members representing all of the major Jewish and Christian denominations in the city. The mayor also issued a city proclamation in support of organ donation. The chapter has recruited employers to provide donor cards to their employees through pay envelopes and a local singer wrote a song to promote the program, which was played for the committee.

The San Antonio chapter of Hadassah has accomplished all of this with only $1,700 in donations. Ms. Bell asked the Secretary's office to consider awarding grants to support the administrative costs of communities and projects like this one. She also asked the Department to develop and distribute public service announcements that communities could customize. Finally, the chapter would like the Secretary's assistance in including donor cards in the pay envelopes of the more than 75,000 military men and women stationed in San Antonio.

Discussion

Less than 5 percent of all medical schools in this country, and none of the top 10, devote 45 minutes or more to organ donation education, even though physicians play a major role in determining whether or not organs are donated. More than 45 minutes worth of training in organ donation should be mandatory for all healthcare personnel. The deans of medical schools should be recruited to the Secretary's Initiative.

Division of Transplantation Extramural Grant Program
Lynn Rothberg Wegman, M.P.A., Director, Division of Transplantation, HRSA

The goal of the Division of Transplantation extramural grant program is to learn more about what works to increase organ and tissue donation. The Model Interventions Program focuses on increasing donation intent and consent, with a strong social and behavior emphasis. Most projects are funded for 3 years and one-third focus on increasing minority donation. All grantees are consortia of clinical and social/behavioral research experts, and their performance measures are increased consent rates or declarations of intent coupled with family notification. The division has funded 35 projects through this initiative since 1999 for a total of $26 million. The Clinical Interventions Program is designed to implement and evaluate clinical processes and practices that increase the number of organ donors and/or transplantable organs. The Division will award $3 million to 18-25 projects for this initiative in 2002.

Subcommittee Reports

Four of the eight subcommittees met on this first day of the meeting and subsequently summarized their discussions for the entire committee.

Report of Subcommittee 1: Organ Procurement and Transplantation Network (OPTN) Kidney/Pancreas Allocation Review
William Harmon, M.D., Subcommittee Chair

Subcommittee 1 decided not to duplicate the work of the Organ Procurement and Transplantation Network (OPTN), but it will review a wide range of topics, including donation, allocation, and access to the transplant list. The subcommittee will also review specific OPTN activities and make recommendations with regard to them. The subcommittee plans to address the allocation of kidneys and pancreases and whether length of waiting time is a reasonable basis for kidney allocation, as well as financial barriers to joining the waiting list and sustaining patients after transplantation, access to transplantations, and the final rule on the OPTN. The subcommittee requested more face-to-face meeting time at future ACOT gatherings.

On average, patients who receive a kidney transplant receive an extra 10 years of life. The subcommittee concluded that kidney transplantation is a life-saving (-extending) procedure for everyone with end-stage renal disease (ESRD), regardless of age, sex, race, or disease.

While more than 51,000 patients are on the waiting list for a kidney, only slightly more than 8,000 kidneys were donated in the past year. The disparity is growing as the number of patients with ESRD increases. By 2010, as many as 200,000 new patients per year may need a transplant and the prevalent population may be as high as 670,000. This need will clearly not be met by cadaveric donors, so the number of living donors needs to increase. If one of every 3,000 Americans agreed to become a nondirected donor, the waiting list could be eliminated. The subcommittee believes that a registry of living donors is urgently needed.

More data are needed to assess the crisis stemming from the imbalance between the number of candidates for pancreas transplantation and the number of donors. More data are also needed to determine whether pancreas transplantation is a life-saving procedure.

Report of Subcommittee 2: OPTN Heart/Lung Allocation Review
Bartley P. Griffith, M.D., Subcommittee Chair

Approximately 42 percent of organ donors yield a heart, and Subcommittee 2 believes that this percentage should be higher. Some countries, such as Spain, manage their donors differently and achieve much better outcomes. ACOT should recommend clinical trials to evaluate changes in practice patterns in the management of donors.

Report of Subcommittee 3: OPTN Liver Allocation Review
Lawrence G. Hunsicker, M.D., Subcommittee Chair

Subcommittee 3 recommended that it exchange minutes with the United Network for Organ Sharing (UNOS) Liver Committee and invite the UNOS committee chair to the subcommittee's deliberations. Subcommittee 3 urges OPTN and UNOS to re-examine allocation based not only on severity but also on geography and other factors.

Subcommittee 3 plans to address these issues:

• Research on ways to optimize donation and improve the efficiency of use of donor organs, including the science of retrieval and outcomes, high-risk donors, and non-heart-beating donors
• Ethical and public policy issues relating to high-risk groups
• Research on which patients benefit most from transplantation and which do not benefit
• Analysis of nonsurvival outcomes, such as quality of life
• Determination of whether cadaveric sources will ever be sufficient to meet the need
• Assessment of the impact of different policies on the survival and quality of life of patients on the waiting list
• Discussion of how to obtain consent from families of cadaveric donors, and whether presumed consent is appropriate or feasible

Report of Subcommittee 5: Improving Systemic Performance-The Law
Robert P. Charrow, J.D., Subcommittee Chair

The Uniform Anatomical Gift Act of 1987 is a model act that has been adopted by several States, sometimes with variations. Under this act, anyone over age 18 is eligible to make a gift of ones organs but such gifts can only be made by a document of gift signed by the donor or by others on the donor's behalf if the donor is unable to sign. A driver's license may be evidence of a donor's intent and no one other than the donor can revoke the donor's intent. Several States allow individuals to make a gift of their organs through their wills and this becomes effective immediately upon death, without the need to wait for probate. These individuals are empowered to act on behalf of the decedent, in the following order: spouse, adult children, parents, adult siblings, grandparents, and guardian at the time of death.

Discussion

Mr. Kress will solicit feedback from ACOT members on the subcommittee structure and communication mechanisms. Adding more face-to-face time to the committee's meetings would be difficult, but the subcommittees could schedule additional conference calls to conduct their business. The ACOT listserv and other mechanisms should also be considered to enhance communication among committee and subcommittee members.

Centers for Medicare and Medicaid Services (CMS) Update
Leslie Norwalk, Policy Director and Counselor to the Administrator, CMS

Since 1973, Medicare has paid for kidney transplantation for virtually all Americans, regardless of age or disability. Once an individual receives a kidney transplant in a certified facility, he or she is automatically eligible for Medicare. Recipients of other types of transplants, however, need to be qualified for Medicare by other factors, such as age or disability. Medicare covers the recipient's transplant but not the organ acquisition or pretransplant services. Coverage for immunosuppressant medications ends 3 years after the transplant but resumes when the individual qualifies again for Medicare through age, disability, or another transplant.

OPOs can only receive payment from the Centers for Medicare and Medicaid Services (CMS) for organ procurement if their service area is sufficiently large and they have procured organs from at least 24 donors or have the potential to procure organs from at least 50 donors per calendar year. OPOs can be terminated if they are not in compliance, but it is not clear that CMS has any options other than termination for noncompliant OPOs.

The Association of Organ Procurement Organizations (AOPO) believes that population-based outcome measures do not account for a population's organ donation potential.

Discussion

In analyzing organs transplanted as a measure of OPO activity, CMS is attempting to increase donations and successful transplants. CMS does not want to punish OPOs for the practices of organizations not in their control (such as potential donor hospitals), but does want to encourage OPOs to help in these areas, as they have relationships that CMS lacks.

The renal community would like to collect peri-implantation biopsies to determine whether organs are suitable for transplant, but the cost of these procedures is not reimbursed. Perhaps CMS could pay for processing peri-implantation biopsies by a consortium of centers interested in studying this question.

While the primary measure for OPO performance should still be organs recovered, OPOs could also be evaluated based on the cost of acquisition of each organ, as costs per organ are escalating much more rapidly than the costs of diagnosis-related groups (DRGs). A factor in this increase is that donor hospitals are passing on very large costs to OPOs. CMS has never rated OPOs based on their acquisition rates because it does not want them to make judgments about whether to acquire organs based on costs.

Public Comment

Myles Kaye stated that the Model for End Stage Liver Disease (MELD) system has increased costs for patients, transplant centers, insurance companies, and government agencies. Relying on only three diagnostic tests does not allow transplant centers and physicians to fully evaluate patients for transplantation. For example, the MELD system does not take into account ascites, varices, bleeding, fatigue, edema, or encephalopathy. Mr. Kaye recommended that UNOS modify the MELD system before ACOT recommends that the MELD system become the law of the land.

Full Committee Discussion

Donor Management

Conflicts often arise in trying to preserve both abdominal and cardiothoracic organs and in choosing the order in which to remove the organs. The goal should be that maximization of the preservation of a given organ should not hinder the preservation of other organs. The heart/lung and liver subcommittees should study this issue in greater depth.

An evidence base is needed to develop criteria for managing donors and choosing whether to accept a particular organ. However, setting up such guidelines is not sufficient to change practice. We need to understand how to change practice so as to improve the use of organs. Perhaps we can learn how centers have made this conversion.

Informed Consent

Interceding at the donor level to improve the function of organs from marginal donors is a good strategy, but if this is done in a pilot fashion, each respective recipient needs to sign an informed consent form. However, the institution that collects the organ often does not know who the recipient will be because the initial recipient may not be ready to receive the organ and it may go elsewhere. In such cases, it is not clear which institutional review board (IRB) must provide approval. The need to obtain IRB approval limits the ability of OPOs to participate in scientific studies. ACOT should recommend a formal policy that would allow OPOs to participate in studies in which the recipient's identity is not known.

Patients are not being offered the opportunity to participate in a study but rather to receive an organ involved in a study. Having to choose between receiving a marginal organ and no organ may not be a fair choice. Instead of trying to obtain IRB approval and informed consent from unknown potential recipients, the potential community of recipients could be asked if they accept the practice of nonstandard donor management.

The Office of the General Counsel, HRSA Branch, will address the issue of IRB approval in more detail before the next ACOT meeting.

Outcomes of Transplantation

The liver subcommittee agreed that MELD is an advance but must be extended to include indicators of the best long-term impact on survival as well as issues other than death, such as quality of life and age. MELD focuses so much on giving everyone an equal chance of receiving an organ that it does not take utility into account. An organ from a 65-year-old may be appropriate for a 70-year-old recipient, but may not be desirable for a 20-year-old. The UNOS Liver Committee will be collecting information from transplant centers about the impact of MELD and will use this information to make more informed decisions.

Even though it is flawed, the MELD/Pediatric End Stage Liver Disease (PELD) system embodies a concept (tailoring the organ to the recipient), that requires more focus.

Quality of life is difficult to measure in the transplant field, although an entire literature exists on quality of life in organ transplantation and includes validated instruments. ACOT should address quality of life and other nonsurvival outcomes across a spectrum of organs.

The outcomes of living donor kidney transplants, whether from related or unrelated donors, are substantially better than the outcomes of cadaveric transplants. Yet this is the only time in medicine when an individual is put at risk for something that will not benefit that individual. Marketing living donation means asking people to put themselves at risk for harm and may threaten the voluntary nature of the donation. Emphasis should be placed, instead, on removing disincentives so that, for example, living donors do not lose salary while they recuperate.

Legal Issues

More legal force should be given to advanced directives so that a patient's decisions are not easily vetoed by family members who disagree with the patient's wishes. The fact that a family wants something different from the patient does not justify care in clear conflict with the patient's wishes. Although an OPO can legally procure organs against the family's wishes if the patient has indicated the patient's intent to donate, procuring organs in such situations could damage the OPO's reputation in the community. Public opinion on this issue needs to change.

Texas removed the driver's license designation in 1997 because department of public safety staff were asking those renewing their driver's licenses if they wanted to be a donor, and if the answer was undecided, the response was recorded as "no." ACOT should examine mechanisms for making and recording intent to donate other than through departments of public safety or motor vehicles.

If someone signs a contract to donate organs, the individual should receive more points and a higher place on the waiting list should that individual later need an organ. ACOT should discuss this issue.

Ethics of Organ Donation and Transplantation
Michael A. Williams, M.D., Johns Hopkins University

Because ACOT can make recommendations to the Secretary, it should consider the ethical and human aspects of all of its recommendations. The committee should also consider competing ethical perspectives and have an ethically defensible framework for its recommendations, while acknowledging that its framework may not be accepted by everyone.

Potential donors may not really understand what they are agreeing to have done to their bodies. An informed-consent-like process might alleviate the burden on families, but it might also frighten off potential donors. Advance directives may serve as a middle ground between informed consent and checking a box on a driver's license application, and their use should be encouraged. Registries could also help donors inform their families by providing information to enhance donor autonomy and reduce the burden on families.

Donor Recruitment and Registries

Most registries list only "yes" responses, which inserts a bias against "no" answers and appears to emphasize donation over autonomy. If potential donors are to have a real choice, their choices should be honored, regardless of whether they are the desired choices.

End-of-Life Care, Brain Death, and Donation Requests

Trust needs to be earned. If health professionals' behavior shows that they respect others, they will engender trust as individuals and perhaps communities. Trust is very important in organ donation and transplantation because families decide whether to consent to donation based on their perceptions of trust.

Intensive care specialists have an obligation to perform a brain death assessment competently, truthfully, and in a timely manner. End-of-life decisionmaking must be conducted using an ethical framework for all patients that is based on empathy and compassion, informed discussion in understandable words, avoidance of coercion, and decoupling discussions of the patient's care from discussions of donation. Potential donor families must not be asked to donate until they have been informed that the patient is brain-dead.

Previously, hospitals were not obligated to discuss donation with all families, but all families must be approached in a way that is respectful of their culture and choices. Families not given the option feel that an important decision was taken from them.

Donor Testing and Preparation

Consent to donate is given with great hope that others can be helped. If something unexpected is found in serology testing, such as AIDS or hepatitis, then the family's hopes are dashed because donation cannot occur. Patients and families should be prepared for this possibility and offered a compassionate explanation when their altruistic desire cannot be fulfilled. The privacy interests of the dead person may conflict with the health interests of the family and other intimates if the dead person is found to have a transmissible disease. Serology results must be disclosed to explain why donation cannot occur in such cases.

Organ Allocation

Organs may be allocated on the basis of equity (sickest, most likely to benefit, survival duration), utility or efficiency (greatest good to the greatest number), or viability of organs (distance/time to transport, histocompatibility matching).

Should the impact of the patient's past behaviors (e.g., alcoholism, tobacco smoking) on their illness affect their eligibility for receiving an organ? To assign responsibility, the behavior must be voluntary, but addictive behavior is not voluntary. Moreover, the cause/effect relationship between behaviors and the illnesses that lead to the need for an organ is not clear and outcomes for formerly alcoholic liver recipients are as good as those of other patients.

Patients who have already received an organ and have complied with their care are considered as eligible for a new organ as those who have never received an organ. However, subsequent transplants have a lower success rate, which is taken into account in determining eligibility.

Although physicians and medical centers have an obligation to individual patients, they also have a sometimes-conflicting obligation to all other potential recipients. Healthcare providers have an obligation to participate in the allocation system in good faith and to not try to "game" the system by misclassifying a patient's status.

Recipients

Recipients need to understand that they risk exposure to transmissible diseases and malignancies, in spite of donor screening practices. They should also understand the importance of posttransplant compliance, the long-term effects of immunosuppression, and the risk of dying while on the waiting list. Healthcare providers must help patients and their families develop advanced directives, explore treatment alternatives, find palliative care options to manage symptoms, and address emotional and spiritual challenges. This does not mean that physicians should "give up" on these patients or not resuscitate them, but transplant patients should be offered the same treatment options as all patients with chronic, life-threatening diseases.

Living Donors

Removing an organ from a living donor provides no tangible benefit to that individual, so its justification is uncertain, although denying someone's request to donate violates the individual's autonomy. Living donors are owed competent preoperative assessment, surgical management, and postoperative care. Their interests should have equal weight to those of recipients. Living donors should, perhaps, receive preference on the recipient list if they subsequently need an organ. Living donors need to discuss all of the risks and benefits of the procedure and think about these before signing their consent. The safety of the care of living donors needs to be enhanced.

Discussion

In conditions of temporary scarcity, enough resources will be available to treat everyone over a period of time, but these resources will be scarce during some of that period. Temporary scarcity should be distinguished from persistent scarcity, in which it will not be possible to treat everyone over a period of time. With liver and cardiac cases, the scarcity is persistent, not temporary. According to the criterion of urgency, which carries a great deal of weight in allocation, the patient who is most likely to die without the treatment is the one who should receive it. Urgency has the most moral persuasiveness in cases of temporary scarcity because anyone who is not treated loses that chance permanently. However, in persistent scarcity, such practices are much less plausible. Instead of allocating organs on the basis of how much the patient will lose if not transplanted, we should consider how much good will result from treatment.

Perhaps medical staff, families, and people needing organs who game the system should be penalized. But it is difficult to punish a patient for obtaining something that is in the patient's best interests. Healthcare providers can and should help patients understand how the system works and how to act within that system to their best interests.

If the "yes" is favored too much over the "no," autonomy is constricted. It is perfectly reasonable for society to favor a "yes" over a "no," but the societal expectation to say "yes" should not deny people the opportunity to say "no" and register that choice.

Information on the natural history of patients waiting for lung and heart transplants is urgently needed. ACOT should support registries and research on end-stage heart and lung disease, as well as advanced liver disease.

When a physician contracts with an individual patient, the physician's obligation is to consider only whether the therapy will benefit the individual patient, and not the impact on everyone else in society. Society must do the rationing and determine whether the therapy is available to that patient, as physicians cannot carry both obligations simultaneously. To reduce the need to ration scarce resources, the number of organs available should be increased and the number of people needing organs should be decreased through preventive medicine.

Improved Identification of Potential Donors

Understanding Potential for Organ Donation and Sources of Donation Improvement
Suzanne Lane Conrad, Executive Director, Iowa Donor Network

This study involved the systematic review of hospital medical records of deceased patients to determine which were brain-dead and therefore candidates for organ donation. Extensive data were collected on each potential organ donor, as well as on the hospitals. The investigators received data from 35 OPOs on 18,524 brain dead potential organ donors in 1997-1999.

The percentage of referrals of potential donors to OPOs increased from 76 percent of families of potential donors in 1997 to 85 percent in 1999 (the conditions for participation went into effect in 1998), and the percentage of families asked to donate increased from 81 to 87 percent. However, the consent rate was stable at around 54 percent.

Of potential donors, 21 percent were African American, 4 percent were Asian, 5 percent were other, and 70 percent were Caucasian (including Hispanic). But 83 percent of actual donors were Caucasian, 12 percent were African American, 2 percent were Asian, and 3 percent were other. Only 76 percent of African American families were referred to OPOs, in comparison with 83 percent of Caucasian families.

Most (57 percent) potential donors were in hospitals with 350 or more beds, and another sizable proportion (37 percent) was in hospitals with 150-349 beds. Eighty percent of potential donors came from 20 percent of the hospitals.

Sixteen participating OPOs provided complete data on their patients. Their conversion rates of potential to actual donors ranged from 32 to 58 percent. Referral rates ranged from 65 to 99 percent, while request rates ranged from 77 to 99 percent. The donor pool and conversion rates remained relatively stable over the study's 3 years.

Identification of Potential Donors in Quebec Hospitals
Réal Cloutier, M.D., M.Sc., Practice Enhancement Division, Collège des Médecins du Québec

This study was designed to improve physicians' awareness of identification of potential donors, learn more about potential donors in Quebec's hospitals, and increase the number of donors. Of the 93 acute care hospitals in the province, 82 participated in the study, which involved reviews of medical records from the last 24 hours of life to identifying brain death.

The investigators identified 364 potential donors representing 1.5 percent of all hospitalized deaths. Of these 364 patients, 267 had been identified as brain-dead by a physician and apnea tests had been conducted on 198. Two hundred and thirty-one families of the 364 potential donors were asked to consider donation, and 155 of these families agreed to donate.

The rates of potential donors among hospitalized deaths were approximately three times as high in the province's four adult tertiary trauma centers as in adult hemodialysis centers, and more than four times as high as in hospitals in distant regions of Quebec. Most potential donors came from 21 of the 82 hospitals in the study.

With a 1.5 percent rate of potential donors for all hospitalized causes of death, Quebec could achieve 30 donors per million. But this would require increasing the knowledge of physicians in some hospitals and improving recordkeeping.

Discussion

ACOT should recommend continued funding for the study described by Ms. Conrad. ACOT needs these kinds of data to address the consequences of organ donation and various programs.

For accreditation, OPOs must conduct death record reviews. But these are expensive and CMS is therefore reluctant to cover them. Many OPOs do use death record review data to change their behavior and increase organ donation. Death record review is not really expensive if it results in recovering more organs and saving more lives.

Regional differences are probably due to differences in population density. OPOs with lower population density have fewer potential donors, but it is not clear why consent rates differ by region. Remote hospitals also have difficulty transporting patients to specialty centers for critical care. Some patients arrive already brain-dead. If intensive care unit beds are allocated strictly on the basis of benefiting the patient, then patients who appear to be brain-dead will not be accepted. But given the center's role in organ donation and transplant and providing good care to the family, such patients should be admitted.

Ms. Conrad's study identified some superb OPOs. These data might be used to develop some best practice recommendations to raise the bar for performance in all OPOs.

Legislative Briefing
J. Craig Burton, Health Policy Advisor to Senator William Frist

The U.S. Senate's previous focus on organ transplantation was on allocation. But in the last year and a half, the 107th Congress has shifted its attention to increasing the pool of organs. Last spring, the House passed a bill that included several initiatives, including grants for demonstration projects and reimbursement for travel and subsistence for living donors. Earlier this year, Senator William Frist introduced a bipartisan, comprehensive organ donation bill that provides new grant authority for demonstration projects, reimbursement for travel and other expenses for living donors, evaluation of prospective organ donor registries, and increased public and professional education.

Discussion

Senator Edward Kennedy chairs the Senate Committee on Health, Education, Labor, and Pensions, and will decide whether the committee will hold hearings on the bill. Hearings can provide input into the policymaking process and inform the public.

None of the pending bills addresses allocation. Several bills were introduced in 2000 to revise the allocation system, but none were passed and Congress appears to want to move away from this divisive area to an area that has a great deal of support.

Presentation by Living Donors and Recipients
Dennis Riley, Organ Donor
Ashley Rader, Organ Recipient
Della Pianalto, Organ Donor
Nicole Williams, Organ Recipient

Ashley Rader was a normal 16-year-old student athlete with an active social life when she began to experience excessive fatigue, vision loss, and difficulty breathing. Although Ms. Rader had never been diagnosed, her kidney function was minimal and she began dialysis. She could no longer attend school and stopped most of her activities. Ms. Rader eventually developed chronic, necrotizing pancreatitis. Her father posted a notice in church asking for a volunteer to donate a kidney to Ms. Rader. After Mr. Riley donated his kidney, Ms. Rader's life changed dramatically. In the year since the transplant, Ms. Rader has graduated from high school, begun exercising again, and made plans to attend Penn State University in the fall.

After Dennis Riley saw the notice asking for a volunteer to donate a kidney, he contacted the transplant coordinator, who sent him a video and brochures on living donation. Mr. Riley was tested extensively and found to be an appropriate donor for Ms. Rader. The transplant took place on April 25, 2001, and Mr. Riley was back to normal in less than 3 weeks.

When Della Pianalto moved into her house, she and her neighbor, Nicole Williams, quickly became friends. When Ms. Williams needed a kidney, Ms. Pianalto asked to be tested to donate her kidney. Her main concern was that she might lose income during the surgery and recovery. Fortunately, as a Federal employee, Ms. Pianalto received 30 working days of administrative leave, which was sufficient to meet her needs. The surgery was performed on January 23, 2002, and was very successful. Ms. Pianalto would happily do it all over again, and has learned that it is the "best feeling to save someone's life, especially when it is a good friend." Nevertheless, Ms. Pianalto knew nothing of kidney donation before her experience and suspects that if she had known more sooner, she would have donated sooner.

Ms. Williams was diagnosed with kidney disease in 1993, a few months after giving birth to her daughter. By March 2000, her condition had worsened and her options were transplant or dialysis. Ms. Williams's initial fears about receiving an organ were dispelled through information from her transplant surgeon. The kidney functioned immediately and Ms. Williams left the hospital 9 days after surgery. Ms. Williams is now a full-time student who volunteers at her daughter's school without having to make arrangements at the dialysis center. She thanked Ms. Pianalto for giving her her life back.

Subcommittee Reports

The remaining four subcommittees met and subsequently summarized their discussions for the entire committee.

Report of Subcommittee 4: Educating and Recognizing Actual and Potential Donors
Arlene J. Locicero, Subcommittee Chair

Subcommittee 4 agreed that education of youth should begin when children are very young and that education should also be provided to members of the military and the clergy.

A medal is needed that is generic enough to honor both tissue and solid organ donors. If the medal is a piece of jewelry, it will be more visible. The courage of donor families should be recognized because it takes courage to recognize that a loved one will not live and to take the next step.

ACOT needs to reach out to organizations to remove impediments to donation and design incentives. Information should be posted on the Internet to increase accessibility, especially to young people.

Report of Subcommittee 7: Meeting the Needs of Multicultural Populations
Robert S.D. Higgins, M.D., Subcommittee Chair
Denise Y. Alveranga, M.D., LifeLink Transplant Institute

Subcommittee 7's charge is to examine transplantation rates, access, and outcomes among those who are underserved in society and in transplantation. The subcommittee also is seeking ways to reduce disparities in transplantation.

Most races have had similar donation rates in recent years. However, transplantation rates for African Americans are lower than for whites for all waiting lists except liver. Rates also are lower for Asian and Hispanic patients waiting for a kidney or lung, but higher for those waiting for a heart. In 1998, the median waiting time for whites was 900 days, and for African Americans and Asians was nearly 1,500 days.

If the donor population is predominantly white, the current human leukocyte antigen (HLA) matching system probably advantages whites. More than 60 percent of the allocation points for whites come from HLA points and 32 percent from waiting time. In contrast, only 44 percent of points for African Americans are from HLA matching and 48 percent from waiting time.

The UNOS Minority Affairs Committee recently re-evaluated the HLA matching system to see what would happen if no points were awarded for B and DR matching or for B matching alone. If matching points for both B and DR were eliminated, transplants in African Americans would increase by 10. 4 percent, in Asians by 10.8 percent, and in Hispanics by 11.4 percent. If points for DR matching were maintained and points for B matching were eliminated, the increases would still be significant: African Americans 8.3 percent, Asians 7.5 percent, and Hispanics 5.4 percent, while transplants in whites would decrease by 4.7 percent. Graft failure rates would not increase significantly for HLA mismatching at the B locus, but would increase for HLA mismatching at the DR locus. Matching at the DR locus therefore appears to account for most of the benefit previously ascribed to matching at the B and DR loci.

Medicaid policies governing transplant decisions vary by State. A greater percentage of minority than white patients have Medicaid coverage only, which affects their access to transplants. Minorities tend to have poorer outcomes than whites 3 years posttransplant.

Report of Subcommittee 6: Improving Systemic Performance: The Professions
Diana Lugo, R.N., Ph.N., M.B.A., Subcommittee Chair

Subcommittee 6 will focus on identifying where the problems are, evaluating the wealth of data available, and developing best practices.

Report of Subcommittee 8: Clinical Issues, Including Alternative Organ Sources
Francis L. Delmonico, M.D., Subcommittee Chair

Live organ donation is a central concern of Subcommittee 8. In 2001, the number of live kidney donors exceeded the number of cadaveric donors. Evidently, the organ donor shortage cannot be solved by cadaveric organ donation alone. Moreover, live organ donation provides accessibility, immediacy, and sometimes (e.g., with kidney) affords the best opportunity for success.

Live organ donor deaths are not limited to liver donors. A recent survey of all transplant programs in this country showed that two live kidney donors recently died from perioperative complications, and one is in a persistent vegetative state.

Live donors should be competent, willing to donate, free from coercion, medically and psychosocially suitable, and informed of the risks and benefits to themselves and the recipient. The benefits must outweigh the risks and no one should be called on to donate in clinically hopeless situations. Informed consent should be requested in understandable language that makes clear the voluntary nature of the donation. Potential donors should understand the procedure fully, as well as the expenses involved and the potential impact on their ability to obtain life and health insurance and ability to obtain future employment. Expected outcomes for the recipient and the transplant center's statistics on donor and recipients outcomes should also be communicated to potential living donors and their families.

The subcommittee plans to discuss the following issues:

• Process and elements of informed consent, and whether these can or should be standardized throughout the country. The subcommittee will develop a template document that addresses the risks, complications, and postsurgical course of living donation.
• Independent donor advocates to focus on the best interests of living donors because physicians focus on the well-being of recipients. This subcommittee will identify the characteristics of the donor advocate and whether he or she should have full veto authority if a donation appears to be ill advised.
• Standards of live donor care, pre- and postoperatively, as reflecting evidence-based best practices
• Program certification and whether this should be the purview of OPTN, DHHS, or both
• Life and health insurance for donors
• A live donor registry of donor demographics by age and relationship to the recipient, immediate outcomes, sentinel events, need for donor dialysis, donors requiring a transplant, and long-term morbidity. This live donor registry should be central, simple, mandatory, and confidential.

Letter from Secretary Thompson
Nancy Ascher, M.D., Ph.D.

Dr. Ascher read aloud a letter from Secretary Tommy Thompson to ACOT. The Secretary conveyed his greetings and sincere appreciation to members of the committee. He is passionate about increasing the number of donors in the United States and knows that each committee member shares this sentiment. The generosity and altruism of all donors and donor families is truly an inspiration. Still the complications of living donors, including deaths, is of great concern to the Secretary and everyone involved in transplantation. Secretary Thompson asked ACOT to continue to explore ways to ensure that potential living donors face minimal risk and receive adequate information and protections to safeguard their recovery.

Living Donor Liver Transplantation: An Evolving NIH Research Initiative
Jay Everhart, M.D., M.P.H., Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

Living donors have been used for renal transplantation for several decades, and account for more than one-third of all renal transplants today. Living donors were first used for liver transplantation in children in 1989, which led to widespread use of living liver donors and a marked decline in the mortality of children. The success of pediatric left lobe liver transplantation and advances in techniques have led to adult-to-adult right lobe liver transplantations. The adult procedure is technically more difficult than the pediatric procedure and places the donor at greater risk.

The National Institutes of Health (NIH) sponsored a workshop on living donor liver transplantation (LDLT) to review the history and current status of the procedure, as well as the ethical, medical, and surgical issues. As part of this conference, all liver transplant programs in the United States were surveyed. Half the centers reported having performed adult-to-adult LDLT, and most of the remaining centers planned to begin performing the procedure within the next year. Approximately 10 percent of adult transplantation in this country is now done through live donation. The conference concluded that more research is needed on liver regeneration for both donor and recipient, optimization of the procedure, the minimal liver size needed for transplantation, and short- and long-term complications.

NIH will begin an adult-to-adult LDLT cohort study that is collecting extensive data on a limited number of centers that are participating voluntarily. NIH expects to fund 6-10 transplantation centers and 1 data-coordinating center. The study will include a retrospective and prospective database on all adult-to-adult LDLTs at these centers and cadaveric transplantation controls. Comparing the outcomes of recipients of organs from living with cadaveric donors will help patients and potential donors make more informed decisions about donation.

Public Comment

Rhonda Boone described her husband, Danny Boone, a living liver donor who died as a result of a liver recovery procedure in July 1999. Mr. Boone had no reason to question the information he received from the surgeon before deciding to donate part of his liver, and had no place to turn to make sure that the information he received was correct. Although he had several medical conditions, he was still accepted as a donor and no one helped Mr. Boone or his family understand the great risks of this procedure. Ms. Boone requested ACOT's support in ensuring:

1. Mandatory regulation of the approval of potential donors, surgeons, and transplant centers
2. A national registry to collect and disseminate information on complications, morbidity, and deaths related to live donors and recipients
3. Live donor advocates to guide potential donors in their decisions

Michael Hurewitz, the husband of Victoria Hurewitz, also died following liver surgery. The quality of postoperative care Mr. Hurewitz received was very poor and the New York State Department of Health ultimately shut the transplant program down for 6 months following Mr. Hurewitz's death. Ms. Hurewitz requested a moratorium on living donations. In addition, she believes that a presumed consent law would increase the number of cadaveric organs available so that living donors would not need to risk their lives.

Angela Tagliaferri donated part of her liver in December 2001 to try to save the life of a friend's young son. Although the child did not survive, Ms. Tagliaferri does not regret her decision to donate.

Lindsay Meyer died at the age of 17 during lung transplant surgery, when one of her veins was cut too short. Her father, Wayne Meyer, reported that Lindsay spent 2 years on the waiting list, and Mr. Meyer and his wife were never told where she was on the list. In fact, they were told to move from New Jersey to St. Louis because Lindsay had moved to the top of the list and would be deactivated if the family did not move. The entire family did relocate to St. Louis, only to find that Lindsay was not first on the list and that no information was available to them on the outcomes of patients who had been transplanted in that city. The allocation and distribution system for organs is a mystery to patients and their families and leaves physicians with a great deal of discretion.

Miriam Lippe's partner has hepatitis C and Ms. Lippe has found very little information on living donation. Ms. Lippe is working with several others to start their own registry that will benefit centers by providing them with statistics they do not currently have.

Full Committee Discussion

Regulations for Living Donation

The only organ transplantation regulations appear to be those of Medicare. Medicare designation of live transplant programs has helped programs and patients by identifying what is required for successful transplantation. Perhaps some collective body should design regulations for the industry, but no currently existing national organizations could enforce any regulations. However, a national insurance program for living donation could require that transplant programs be reviewed to be eligible for the program. This would help protect potential donors.

Instead of providing a high quality of services because of regulations, the transplant community should provide excellent care because it values high-quality care. Moreover, medical practice is generally regulated by States, not the Federal government, and practices vary by State. More importantly, one can only regulate what is known. With the transplantation field changing so rapidly, any regulations established now would cover only current practice, which is likely to change in the near future. Finally, regulations rarely change how doctors care for their patients.

OPTN does not currently oversee living donor transplantation. Such oversight might provide reassurance that the professionals involved are competent. Since OPTN oversees cadaveric donations, it should also oversee living donor transplantations. OPTN should be asked to evaluate the data or create a committee as a first step.

Two different problems have been discussed: the technical prowess of physicians, and failures in the relationships between the transplant teams and physicians, and the donors and their families. Standards for living donor transplantation should perhaps be higher than for other procedures, because the procedure provides no tangible benefit to the person at risk.

Information for Living Donors and Their Families

Perhaps potential living donors and their significant others should receive psychological evaluations. If the living donor experiences any complications, the family member will be required to provide a great deal of support. If a family's ability to support the donor is in doubt, the donation should not go through. However, psychological testing should not replace face-to-face interactions between potential donors and their families, and physicians and other transplant team members. The informed consent must be proper and broad, and include everyone who might be affected.

With so many families not being fully informed of the issues surrounding live donation, the transplantation community must redouble its efforts to collect data, analyze them correctly, and transmit them to the entire community. A registry is therefore needed of data on all donors. However, gathering follow-up data on living donors might be difficult. When living donors were offered free long-term follow-up care at one center, very few took advantage of the offer.

To help potential donors and their families better understand what living donation involves, they could be given a list of questions to ask their healthcare professionals. However, even if potential donors and their families ask appropriate questions, hospitals do not always answer these questions honestly.

Adult-to-adult LDLT is a new procedure that is being disseminated rapidly, perhaps too rapidly, before the procedure and its risks are well understood. Although new medical techniques are constantly introduced, LDLT is unique in that an individual who will not benefit is put at risk. This procedure should be constrained until more data and experience are available. However, eliminating mortality in LDLT may be an unreasonable expectation. Yet the level of risk should be reduced, and the population should be fully informed of the risks involved.

Dr. Hunsicker will bring these issues back for discussion by the liver allocation subcommittee, and will have a statement ready by the next ACOT meeting.

Disparities

Waiting times differ greatly between races, possibly due to the emphasis on matching donors and recipients, which has been the mainstay of kidney allocation for years. Decreasing the emphasis on matching and focusing more on time on the waiting list might achieve the social good of decreasing the disparities in waiting time, but might also diminish graft survival rates. However, matching at the B and DR loci does not yield substantial increases in graft survival. Dropping B matching would be reasonable and would increase equity without hurting survival.

Eliminating matching points at the B locus would increase organ donations to blacks by about 8 percent and decrease graft survival by about 8 percent, which translates to 21 more graft failures a year. In fact, the benefits may be even greater. One OPO that does not use HLA matching has half the waiting times for African Americans of another OPO that uses HLA matching. Many experts believe that eliminating B matching will yield a substantial increase in access for minorities at the cost of a small increase in organ failure.

The multicultural subcommittee is attempting to collect data on insurance coverage, which could have a substantial impact on access. Some plans limit the number of nongeneric medications that a patient can receive, even though the newer immunosuppressant drugs are not available in generic form.

Legal Issues

The legal subcommittee discussed presumed consent and concluded that several legal barriers, including possible constitutional conflicts, exist. Presumed consent also would probably require changes at the State level that would be considered unacceptable. This subcommittee will discuss tracking the deaths of people removed from ventilators who are not referred for evaluation to OPOs before the respirators are removed. It also will consider the difficulty of persuading medical examiners to release the bodies of infants who have died from shaken baby syndrome. With such a desperate shortage of livers and hearts, not being able to use this resource effectively is "tragic."

States might try reimbursing families of donors for funeral expenses to assess the impact before disseminating the practice more broadly. Presumed consent might gain sympathy in some States. Therefore, ACOT should consider the paradigm of local experiments. The legal subcommittee considered whether to recommend that the Secretary be authorized to undertake demonstration projects in the States to gather data on financial incentives that might increase donation. No data are currently available on the impact of such incentives. But such pilot studies must be properly designed so that they can answer questions on public acceptance of incentives and whether they produce changes in consent rates. The surveys must gather data from the poor and all ethnic groups, as well as majority populations. An important question is whether the willingness to donate, or the actual organ, is to be rewarded.

Conclusion
Nancy Ascher

Advisory Committee on Organ Transplantation (ACOT) Members

Gail Agrawal, J.D., M.P.H., University of North Carolina School of Law
Denise Y. Alveranga, M.D., LifeLink Transplant Institute
Nancy Ascher, M.D., Ph.D., Chair of ACOT, University of California, San Francisco
Phil Berry, M.D., Southwest Transplant Alliance
Dan Brock, Ph.D., Brown University
Robert P. Charrow, J.D., Crowell and Moring, LLP
Margaret Coolican, R.N., M.S., National Donor Family Council
Paige L. Cottingham-Streater, J.D., The Mansfield Center for Public Affairs
Catherine C. Crone, M.D., Inova Fairfax Hospital
Francis L. Delmonico, M.D., Massachusetts General Hospital
Roger Evans, Ph.D., Rochester, MN
Robert D. Gibbons, Ph.D., University of Illinois, Chicago
Bartley P. Griffith, M.D., University of Maryland
Susan Gunderson, LifeSource Organ Procurement Organization (OPO)
Larry Hagman, Liver Recipient
William Harmon, M.D., Children=s Hospital, Boston
J. Harold Helderman, M.D., F.A.C.P., Vanderbilt University
Robert S.D. Higgins, M.D., Medical College of Richmond
Lawrence G. Hunsicker, M.D., University of Iowa
Barry D. Kahan, M.D., Ph.D., University of Texas Medical School
Deborah Lee, M.H.A., LifeQuest Organ Recovery Services OPO
Arlene J. Locicero, Donor Mother
Diana Lugo, R.N., PH.N., M.B.A., St. Vincent Medical Center
Roger R. Luna, Jr., McAllen Medical Center
Amadeo Marcos, M.D., University of Rochester
Edgar Milford, M.D., Brigham and Women's Hospital and Harvard Medical School
Howard Nathan, Gift of Life Donor Program
Mary Ann Palumbi, R.N., Allegheny General Hospital
James D. Perkins, M.D., University of Washington
J. Thomas Rosenthal, M.D., University of California, Los Angeles
Michael S. Seely, Pacific Northwest Transplant Bank
James Shanteau, Ph.D., Kansas State University
Flora Solarz, M.P.S., NYC Health and Hospitals Corporation
Hans W. Sollinger, M.D., Ph.D., University of Wisconsin
Donald M. Stablein, Ph.D., EMMES Corporation
Deborah C. Surlas, R.N., Kidney-pancreas Recipient
Katherine L. Turrisi, R.N., Medical University of South Carolina
Michael A. Williams, M.D., Johns Hopkins University
Carlton J. Young, M.D., University of Alabama, Birmingham
James B. Young, M.D., Cleveland Clinic Foundation

Department of Health and Human Services (DHHS) Participants

Jay Everhart, M.D., M.P.H., Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
Gary Gurian, Secretary's Regional Representative, Region III
Camille Haney, Special Assistant to the Secretary
Jack Kress, Executive Director, ACOT
Lynn Rothberg Wegman, M.P.A., Director, Division of Transplantation, Health Resources and Services Administration (HRSA)
Leslie Norwalk, Policy Director and Counselor to the Administrator, Centers for Medicare and Medicaid Services (CMS)

Other Speakers

Sue Bell, To Save a Life Coalition, Hadassah
J. Craig Burton, Health Policy Advisor to Senator William Frist
Suzanne Lane Conrad, Executive Director, Iowa Donor Network
Réal Cloutier, M.D., M.Sc., Practice Enhancement Division, Collège des Médecins du Québec
Della Pianalto, Organ Donor
Ashley Rader, Organ Recipient
Dennis Riley, Organ Donor
Nicole Williams, Organ Recipient

Members of the Public Presenting Oral or Written Statements

Rhonda Boone
Victoria Hurewitz
Myles Kaye
Miriam Lippe
Wayne Meyer
Angela Tagliaferri