Ms. Gail Agrawal, Chairperson, welcomed the group and read a letter from Larry Hagman, whose last meeting this was to be. Mr. Hagman's letter described his inability to attend due to family obligations and expressed how much he has enjoyed his ACOT membership.
Mr. Remy Aronoff, Executive Secretary, introduced Dr. Russ Wiesner, the newest member, from the Mayo Clinic. Mr. Aronoff thanked ACOT members for the work that everyone has done between meetings and noted that this will be a very full agenda.
Public Solicitation of Donors – Dr. Douglas Hanto
There are important ethical aims in distributing scarce health care: maximizing the benefits from a limited resource (utility), and distributing the resource fairly or equitably among all possible recipients (justice). These two goals will often conflict, however, and trade-offs will be necessary, but they must be kept in mind. This summary comes from Dr. Dan Brock of Harvard Medical School, who is currently working with the government in Thailand, looking at ways to provide limited dialysis in that country.
Organ donation can be thought of along a spectrum that spans from altruism, solicitation, incentives, coercion and theft. The concept of “sales” can occur along this spectrum in multiple places, depending on your position regarding the ethics of sales. Everyone is familiar with billboards that have been used to advertise for a directed liver donation to that individual.
Decreased organ donation allocation: organs are allocated in a non-directed fashion, to patients on the United Network for Organ Sharing (UNOS) waiting list. There are exceptions, such as when organs are donated to family members or friends of those on the list; or when a donor family responds to the public plea made by a potential recipient, and directs the donor’s organ(s) to that recipient. Solicitation allows one to jump the list, which many feel violates fair principles. Therefore, the issue of solicitation is more straightforward for deceased donors than it is for live donation. It is important to remember, however, that solicitation is permitted in both the Final Rule (1999) and in the UAGA (1987).
Living donation is, in contrast, largely unregulated; and there are currently no allocation policies. Living donations have historically occurred between friends and/or family members, which is ethical. Policies for this sort of donation are set by the transplant centers. Donations are increasing from anonymous non-directed donors to the next appropriate person on the list. These “Good Samaritan” donations do not violate national policies so long as payment does not occur. Solicitation can involve unethical and/or illegal practices, however. For this reason, the Health Resources and Services Administration (HRSA) asked UNOS to create guidelines about solicitation. It is relatively uncommon at this moment, which presents an opportunity for the issue to be addressed before it becomes a bigger problem.
The Organ Procurement and Transplantation Network (OPTN) response outlined in a paper written by Dr. Frank Delmonico and Walter Graham, has been that it is:
1. developing guidelines for the appropriateness of donor/donee relations in directed donation from deceased donors; and 2. working to deter media solicitations that are counter to the goals of the National Organ Transplant Act (NOTA), but there is no solution for a family that persists in directing donation(s)
They have stated further that the OPTN cannot regulate or restrict how relationships are developed for the purposes of living donation. It is the goal, however, to prevent sales, remove financial disincentives from donation, and reimburse donor expenses. The OPTN will work to develop guidelines for the psychosocial evaluation of all living donors. This does not really provide transplant centers with practical answers on how to address the real situations that arise, however.
An upcoming paper by James Rodrigue, Ph.D. at Beth Israel Deaconess Medical Center Transplant Center submitted to the American Journal of Transplantation provides insight into acceptable donor types. A survey of centers on acceptable donor types found that only about 30 percent of programs view as acceptable, a person solicited via the Web, newspaper or media. While these donors are not necessarily viewed as acceptable, they may not be refused.
Arguments for solicitation of organ donors note that donors have autonomy. Those who support this position say that one should be able to give an organ to anyone one chooses, and a kidney may be considered a private resource that may be disposed of as the owner wishes. Supporters of solicitation note that the current allocation system may be unfair to certain patients and may favor some over others (in terms of geography, for example). Solicitation may result in greater awareness about donation, and hence generate more donations.
Opponents of solicitation note that donor autonomy is not absolute and must consider the fair rights of others. For example, one must also consider the ethical, legal, and social obligations of the transplant surgeon, nurses, and hospitals; they should not be forced to participate in something they find unethical. Solicitation of deceased donors bypasses the fair policies of allocation and the person who is ethically entitled to the organ. It permits discriminatory practices and favors the well educated and those with financial resources. Solicitation risks the exploitation of donors or recipients and may result in the undetected buying and selling of organs. Finally, it may divert organs to unsuitable candidates for transplantation.
Ideally, we want to balance the rights of the donor who claims autonomy with the rights of all of those who are waiting on the list. When the balance shifts to those on the list, exclusively, it ignores donor rights – which is not acceptable. But, alternatively, we cannot go so far in the other direction that donor autonomy has absolute preference. This would not work with a national allocation policy (it’s like picking the flowers in the public park; when everyone does it, it prevents the system from working for the entire community). Dr. T. M. Wilkinson argues that conditional organ donation should be acceptable; he cites a United Kingdom situation in which a family would only permit donation to a white person and argues that even such a discriminatory donation can be altruistic and acceptable.
Some argue that kidney donors want to be able to direct their donation and will be less likely to donate if this right is removed. This view is not supported by experiences at the University of Minnesota, which requires Good Samaritan donor kidneys to be given to the next patient on the waiting list (See AJT 2004;4:1110-6). A national conference on non-directed living kidney donation supported non-directed donation to the list (See JAMA 2000;284:2919-26). Dr. A. Spital reported that 93% of willing donors to a stranger would still donate if they could not direct their donation (See Transplantation 2003;76:1252-6). If we educate people, we can show that the allocation system makes sense and they will accept it.
Is the donor allocation system fair? UNOS is required to conduct allocation in a way that balances justice, equity, and utility. The system includes broadly representative committees that develop, solicit public comment on, approve, and review allocation policies. The system involves both public and governmental accountability and oversight. The model used for deceased donation can be applied, with modifications, to live donor transplantation as well.
Does solicitation increase awareness about donation, and donations themselves? Media publicity does increase awareness about donation; anecdotally, there are instances where people come forward as a result of solicitation. But, there are no data on this. Stories used for solicitation suggest that the people soliciting are exempt from the criteria used for allocation to the list, but we should remember that all people have stories. Consideration should be given to putting people’s stories on UNOS Web site so they reach the public outside of a solicitation setting.
Solicitation may yield discriminatory practices: the donor can choose recipients based on a discriminatory basis, which is unethical because it places some at a disadvantage (e.g., those who are less attractive or have less “compelling” stories). It is clear that directed donation favors those with public relation skills or other advantages (e.g., ability to use the media or Internet, physical attractiveness). Internet access, for example, varies greatly by age, socio-economic status, and geographic location. When the recipient can pay for the donor’s expenses, it favors those who are better off and have a greater ability to cover these costs for a donor.
If solicitation becomes common, people may elect to solicit a stranger rather than ask a family member for a donation because they may not be willing to ask their family to make this sacrifice. This could decrease donations. In fact, there are examples of this happening. In India, family member donations dropped because it was safer and easier to buy an organ than to ask a family member for one. In Hong Kong, the living donation rate dropped when Hong Kong rejoined China. In Egypt, live donor liver transplants have nearly disappeared because people are going to China to purchase deceased donor livers. Additional risks from solicitation include illegal demands for payment and the donor contacting the recipient at a later date for assistance. For these reasons, preserving the anonymity of both donor and recipient is preferred by many, unless the donor and recipient wish to meet.
Solicitation may divert organs to unsuitable candidates, to those who are not appropriate recipients. The young man in Texas (who had a billboard soliciting an organ) was not a good candidate, and he died within a year of recurrent liver cancer. One wonders what happened to the next person on the waiting list who did not get the liver because it went to this young man.
In conclusion, solicitation of deceased donors by recipients (or their agents) should not be permitted. Solicitation of living donors may involve unethical and illegal practices that place both donors and recipients at risk, and should be discouraged. Non-directed donation from a deceased or living donor to the first patient on the waiting list is preferable, and unlikely to discourage donation.
UNOS is best positioned to, and should, regulate living organ donation and allocation. The same principles used for non-directed, deceased-donor allocation should be applied. Directed donation from deceased and living donors to family members and persons with preexisting emotional relationships should continue. UNOS must create a policy that defines the acceptable preexisting emotional relationships, and the OPTN Final Rule should be amended to cover this. One must be willing to accept that donor autonomy is not the end-all, be-all in this situation.
A common comment made by supporters of solicitation is that no one is disadvantaged by this. Such a statement assumes that the directed donor would not have donated to the list, but evidence suggests otherwise. Most would give to the next person instead of the directed recipient. Supporters also note that we permit directed donation by family and friends, so why not allow this as well? The response is that there are unique relationships and obligations among family members. If we didn’t permit donations among relatives, it would cripple donation rates. Finally, supporters of solicitation complain that those without living donors are penalized by events they cannot control, but the fact is that the presence -- or absence -- of special qualities (e.g., moving story, attractive physical features, social standing) should not determine allocation.
What are the alternatives to solicitation? We should decrease financial and other disincentives for live and deceased organ donation (offer paid leave for donors; offer reimbursement for lost wages and expenses for live donors; and provide first-person person consent. We should work to increase altruistic live donation (by related and unrelated donors) (e.g., ABO incompatible, desensitization, paired kidney exchange, and “Good Samaritan” non-directed donations). We need to keep working to increase deceased donor donation through mechanisms that include the Organ Donation and Transplantation Breakthrough Collaboratives and presumed consent. We should use extended criteria organs and donors after cardiac death and work on continuing improvement in outcomes and xenografting.
Dr. Solomon asked if there is any research on the motivations of Good Samarians.
Dr. Hanto replied that there is, mainly among blood or bone marrow donors who want to help. There are also other individuals with other motivations as well; a large number are screened out of the donation process on the initial phone call. They are “altruistic,” but they have psychological, medical, or other reasons to be excluded on the initial phone call.
Dr. Solomon asked if, since the Organ Donation and Recovery Improvement Act allows financial reimbursement for expenses, there is a concern about solicitation and/or incentives that stem from this. The Act provides for reimbursement of donors for travel and subsistence expenses and other incidental non-medical expenses that the Secretary may authorize by regulation. HRSA awarded an $8 million 4-year cooperative agreement to the Regents of the University of Michigan to operate this program. Dr. Hanto commented that such funding would remove a barrier to donation.
Mrs. Boone remarked that she felt it’s unethical to solicit donors into a process that has no long-term follow-up on results for donors. Dr. Hanto replied that the system has always been focused on the safety of live donors, but there is an increasing concern about the lack of long-term data on this population. The University of Minnesota has some good data and looking long-term at this issue. But, it’s hard to get donors to come back for follow-up visits. Barriers to knowing these patients are safe include reimbursement, patients failing to return for follow-up visits, and the expense of coming back for follow-up. It’s a big focus and priority of groups like UNOS and American Society of Transplantation, especially live liver donors. Mrs. Boone noted that most of the likely problems are not known to donors when they accept the request to become a donor. They have no idea about the quality of life issues, for example. Dr. Hanto stated that most transplant programs try to talk about the risks and complications, and this has been an increasing focus in the last few years. A new video produced by the American Society of Transplant Surgeons addresses living donor issues.
Dr. Migliori said that Dr. Hanto’s conclusions hinge upon the determination of an acceptable “pre-existing emotional development,” and he asked what Dr. Hanto felt those parameters are. Dr. Hanto responded that this will be hard to define in detail and it will be necessary to do so generally and give examples. Certainly, friends and relatives are acceptable. The struggle occurs where the relationship exists solely for the purposes of donation. That’s one extreme. (Matchingdonors.com is an example of this). Yet, 40 percent of Americans say that their closest relationships exist with people they relate to on the Internet. They view these as friendships with emotional content. One cannot prohibit how people forge friendships. Another example is someone asking for a donation at church. Our view has been that, where close relationships exist, solicitation should be acceptable. Friendships within the workplace or in a community (however that is defined: religious, geographic, Internet, service) are usually seen as acceptable. These are hard to define, however. The goal is to prevent exploitation of both the donor and the recipient.
Ms. Conrad agreed that, as a living donor herself, it’s like herding cats to get donors to come back in for follow-up. Donors should be able to get needed follow-up through their local doctors, and have the results sent back to the Centers. She commented that donors such as herself are healthy, and don’t want to go back to the transplant center. The problem is one of resources; we can’t just send a donor a letter saying, “go to the doctor.” It takes more effort than that to get the information on donors.
Dr. Reyes asked about the numbers of solicitations a year. Dr. Hanto stated that it’s about 70-80 cases a year. The numbers are relative and the social question is more critical. The small number raises the question of whether they should direct attention to prevent solicitation, or if we should just keep watching the situation. Dr. Reyes remarked that it’s strange to imagine that the Internet is not an acceptable solicitation venue, but a church is. That’s not reflective of how people really live; more people log in than go to church. It may be extreme to prohibit such solicitation, and we may miss opportunities to develop the field. Dr. Hanto agreed that solicitation has received more publicity than are justified by the numbers, but there is a risk that it can be a bigger problem. The field took a strong stance against solicitation of deceased donors, which was nipped in the bud. But, over the long-term, this may be a new, bigger, problem. We don’t want a blanket policy for something that’s not a big problem; but it is a problem for some transplant centers.
Dr. Wiesner raised the issue of directed donation to a celebrity, which has a detrimental effect on the public’s perception of fairness. Every time a celebrity is transplanted, there’s a question about his or her priority on the list. The field has to be squeaky clean.
Dr. Scantlebury asked if, with regard to the large numbers who come forward as potential donors for well-known people, there is a way to think of these individuals as potential donors for others. Can we capture them as donors for others who are on the list, rather than being directed donors for one particular person. If they are educated about the system, can they become non-directed donors? Dr. Hanto felt that this should be encouraged and that we should educate the anonymous donor so that he or she is encouraged to donate to the next person on the list, or participate in paired kidney donation. It’s more work, but it’s a really an effective thing to do and is all about compatibility, and who is on the list. The community can come together and be uniform and hold the line that these donations have to go to the next person on the list (as occurs at the University of Minnesota), which will be hard. Or, we can develop a policy to address this situation. There will be resistance because of resources and conceptions of autonomy, as well as push-back from libertarians. It may not be doable, but it has to be on the table.
Ms. Principe commented that she felt she would be remiss if she did not underscore the need for education in this country about live donations. It’s the key piece. When we do long-term follow-up, in addition, we have to be careful that we embody all cultures and perspectives and that whatever we develop is multicultural. What works in Minnesota and Iowa may not work elsewhere in terms of people’s approaches to life. A lot of things would be prevented if we did a better job of educating the public. If we get that out there, we can help resolve a lot of problems.
Ms. Rosenzweig said that the whole reason we are having this conversation is because we are dealing with something that is both scarce and valued. She asked for clarification on understanding xenografting’s pros and cons. Dr. Hanto is in the process of writing about this. Many years ago, xenografting was the latest, greatest thing, and a lot of money was invested in it. He thinks xenografting should be revisited. Ultimately, it’s going to be the solution for many patients. There has been a decrease in funding and publications in the last decade, however.
Dr. Conti said that the balance of utility and justice is important. In the circumstance of a live donor without emotional connections, do you think a six-month waiting period could decrease the chances for exploitation? Dr. Hanto reported that he does not know if there are data on this. He would be hesitant to take this approach because it would be burdensome to enact such a long waiting period. Some programs have some waiting periods for high-risk donors (more like a month). It might prevent some folks who could really benefit from an immediate transplant from getting the organ.
Dr. Lorber suggested that ACOT consider some of the presentation points as potential action items. Since the committee had a long discussion on the need for long-term donor follow-up and the idea of mandating a registry, the issue of funding for such a registry could be important as an objective and could really help to understand how safe donation is. Dr. Hanto commented that UNOS has done a few things; any death of a live donor has to be immediately reported to UNOS, for example. There is resistance to provide more data, on the part of transplant centers and UNOS has decreased the amount of data it collects. But, it’s important and we should do it. In addition, solicitation is one key issue related to deceased donation and is still technically permitted by the Uniformed Anatomical Gift Act and the final rule. It’s not a big problem yet. Another important discussion is about donor autonomy and how much is allowed. This will frame the debate on where we go after that, and will drive the eventual solution. Another issue is how to define “pre-existing relationships” in a way that’s acceptable.
Dr. Scantlebury raised the recent comment on Matchingdonors.com that suggested transplant centers can list their patients on the site and get reimbursed by CMS. Dr. Hanto commented that the site sent an email soliciting the transplant programs and surgeons to list potential recipients on Matchingdonors.com , a marketing approach to add people to their list. Ms. Newton, representing CMS, said that this statement was an assumption on the part of Matchingdonors.com , and that CMS will release guidance on this soon.
Ms. Agrawal asked if any members of the public had any questions.
Ms. Luebke introduced herself as a kidney donor from 1994 and Nurse Practitioner with the Living Donor Advocate Program. The nurses with the Advocate Program have a few comments. They request that any person speaking or publishing about living kidney donation refrain from using terms such as “minimal risk to the kidney donor,” or “being a kidney donor is minimal risk,” or “recognition of the minimal risk to be a living kidney donor.” This language minimizes the risks that donors are taking when, in fact, they are the only ones taking a risk. In response to “minimal risk,” Dr. Mark Alisio, a professor in the Department of Bioethics at Case Western Reserve University, prepared this statement for Ms. Luebke to read.
Minimal risk is a term most commonly used in human subjects research and is usually defined as (roughly) no greater than one would encounter in the normal activities of everyday life. Whether a study is “no risk,” “no greater than minimal risk,” or “risk[y]” demarcates different criteria that must be satisfied for the study to be approved. There is no Institutional Review Board that would consider the removal of an organ of a living human being “minimal risk,” and to characterize live organ donation as such is grossly misleading.
Ms. Donna Luebke noted that, in terms of protecting living donors when they offer the donation, autonomy only goes so far.
Mrs. Vicky Hurewitz said that she is encouraged by promoting the idea of xenotransplantation. She has been coming to ACOT meetings for five years, and has problems with living donations. She would be very happy to be involved in promoting xenotransplantation and asked how people could get involved and whether there was an advocacy group working on this as a way of getting the focus off the living donor. Dr. Hanto does not know of anything at the moment. He is working on an editorial for the American Journal of Transplantation, citing changes in the research around this and calling for new energy on this. The hope is that it will spawn interest in both the private and public sectors. He welcomes help from everyone.
Myles Kaye, a member of the public, spoke about the use of faith-based groups for solicitation. This happened in his congregation, the rabbi asked for someone to make a donation. The way he presented it was that it was a “no brainer.” When such a message comes from a religious leader, who is respected, it seems so easy. Mr. Kaye wrote to the rabbi, recommending the need to explain both sides of this and noting that there are problems and complications connected with donation. When a religious leader makes the request, one has to be very careful to make sure that all aspects are explained. Dr. Hanto agreed; when an influential person makes the request, it can lead to coercion. He is also opposed to a solicitation in which Jewish people are encouraged to donate to Jewish patients.
Ms. Robinson cautioned about messages put into the public sphere: the message about donation’s risks will be heard by others as well, so we have to be cautious.
CMS Organ Transplantation Regulation – Living Donation – Ms. Marcia Newton
Ms. Newton spoke on final regulations from CMS on new Transplant Center Conditions of Participation in terms of living donation. Living donation is mentioned throughout the regulation in many places including data submission and comparing blood types. But, today she spoke about specific protections for the health of living donors.
In terms of the definition of “adverse events,” CMS did not receive any comments specifically on the definition, but it was clear, from the comments CMS received, that there is concern about this issue. In creating the Final Rule, CMS realized that a death of a living donor might not be defined as an adverse event. This was changed in the Final Rule, so such a death would have to be both reported and investigated. (Final language includes as an adverse event, “Serious medical complications or death caused by living donation.”)
In terms of selection of living donors, CMS focused on selection criteria for determining their suitability for transplantation. CMS received questions about the selection criteria being consistent with the general principles of medical ethics. There is abundant information about this, in the preamble and elsewhere. A Center that performs living donor transplants must use written donor selection criteria in determining the suitability of living donors. The selection criteria must be consistent with general principles of medical ethics. The Center must ensure the medical and psychosocial evaluation of the living donor and must document that the donor has received informed consent. In the Final Rule, documentation of medical suitability was altered. It was originally maintained in the transplant recipient’s records, but this is personal information about the donor and keeping it there would have violated Health Insurance Portability and Accountability Act (HIPAA). Now this documentation is only in the donor’s records.
There are four requirements on living donor management. Centers must:
The proposed qualifications for social workers include a statement originally from the ESRD regulations grandfathering in those who were employed before 1976. CMS also included this language in the Final Rule. (A qualified social worker must meet State licensing requirements and have a Master’s degree from a graduate school of social work accredited by the Council on Social Work Education; or be working as a social worker in a transplant center on the rule’s effective date; and have either two years as a social worker, or one year as a social worker in a transplant program.)
The dietician must also be qualified – proposed qualification requirements were changed in the final rule. CMS received comments that it was proposing different qualification for dieticians in dialysis versus transplant centers. These requirements are much more aligned now.
Centers must have a quality assurance and performance improvement (QAPI) program. Specifically, for living donors, the regulation lists activities transplant centers might want to include in their AQPI programs, such as, selection, management, consent practices and living donor rights. They must have a process for identification, reporting, analysis, and prevention. Centers must conduct analysis and have written policies to address and document adverse events and use the analysis to effect changes in policies and practices. Adverse events are reported not to CMS, but to UNOS, the Joint Commission on Accreditation of Healthcare Organizations (voluntarily), and State health departments per individual State requirements. CMS notification requires Centers to report outcomes that might affect their Medicare approval.
CMS is requiring that there be a living donor advocate or team, based on ACOT’s second recommendation for such an independent living donor advocate/team. CMS wanted to hear from the public on this and received overwhelming support for the idea. CMS has tried to be flexible and non-prescriptive in this area while preserving the rights of the living donor and prospective living donor. The living donor advocate or team must not be involved in transplantation activities on a routine basis. The advocate/team must demonstrate understanding of the possible impacts on donor decision-making and ability to discuss with prospective donors; and knowledge of living donation, transplantation, medical ethics, and informed consent. The advocate or team is responsible for representing or advising the donor; protecting and promoting the interests of the donor; respecting the donor’s decision; and ensuring the donor’s decision is informed and free from coercion.
The informed consent regulations are based on the ACOT’s first recommendation on informed consent standards for living donors. Informed consent policies must inform prospective living donors about all aspects of and potential outcomes from living donation. Elements of informed consent include informing prospective donors that communication between the donor and center will remain confidential and an explanation of the evaluation process. Content must include an overview of the surgical procedure, including post-operative treatment; availability of alternative treatments for the prospective recipient; the potential medical or psychosocial risks of the procedure; national and Center-specific outcomes for recipients and donors, as available; the donor’s health, disability, or life insurance issues; the prospective donor’s right to opt out at any time; and the recipient’s Medicare drug coverage issues.
Drug coverage issues were included due to concerns over some transplant Centers’ policies of offering transplants to Medicare recipients at no cost in order to improve their transplant and/or experience numbers and gain CMS approval. But, the beneficiary who has a transplant in an unapproved facility loses his or her right to immunosuppressant drugs under Part B; Part B coverage fills in the gap in Part D coverage (that is the “doughnut hole.”) Since loss of immunosuppressant drugs would be serious for a beneficiary to give up, CMS wanted this to be addressed specifically.
CMS received a lot of questions about why it did not adopt all of the ACOT’s recommendations on this. The reason is that the ACOT’s recommendations here are very detailed. CMS took the elements it thought were particularly important, but also attempted to allow flexibility on the part of the Centers. Because they are hospital patients, living donors also have other rights under Medicare regulations, such as grievance processes and the right to a safe environment.
For more information, see Centers for Medicare & Medicaid Services web site for “Newly Published Organ Transplant Regulation.” There are links to the Final Rule in Federal Register format, a list of approved transplant Centers, information required for applications and information on where to submit applications.
Ms. Agrawal asked for clarification on how CMS measures compliance and what happens for those that are non-compliant. Ms. Newton replied that this was assessed by looking at outcome measures, using data from the Scientific Registry of Transplant Recipients (SRTR). In terms of process requirements, this is done by using on-site surveys or future reviews. Non-compliance threatens Medicare approval of the transplant Center (not of the hospital). CMS can remove the Center’s approval without affecting the hospital’s certification under Medicare.
Dr. Reyes commented that, in terms of program approval, he had not been aware that CMS had to approve a living donor program for these organs. Ms. Newton clarified that these regulations are not for approval of a living donor program, but for approval of the organ program itself. Medicare does not regulate, certify, or approve living donor programs, but a Center that has such a program is bound by the requirements specific to living donation. They have to be members of OPTN and follow their allocation rules.
Dr. Hanto asked about the advocates/teams, noting that most of the team members are “involved in transplantation,” yet the Rule seems to suggest that these team members cannot be involved in transplantation. Are Centers being asked to go outside the staff for such team members (e.g., hire a social worker) and, if so, how can they ensure that the advocates have the requisite knowledge needed to truly advocate? Ms. Newton said that this is a gray area, about which CMS is intending to publish guidelines shortly. A donor coordinator who is paid by the Center is acceptable. Where it’s a problem is when the person is working with the donor and the recipient at the same time. CMS is looking to follow the regulation with more information. CMS has not found a conflict with someone who does the medical evaluation and the nephrectomy with living donors. They are looking for a donor advocate who is not to be involved in donor transplant activities.
Dr. Hanto pointed out that some of the examples just provided by CMS actually violate CMS’ own regulations. The Rule says the staff can’t be “involved in transplantation on a routine basis,” and the staff at his facility is involved in transplantation 100 percent of their time. It’s their job. His facility has separate teams, which may act as the donor team in one instance, and the recipient team in another, switching back and forth. Coordinator does mainly work with donor, but sometimes they switch and work with recipient.
Ms. Newton said CMS would look further at this. She felt that staff who work with recipients most of the time and donors only part of the time will naturally be more of a champion on the side with which they work more frequently. If it’s not routine for the donor advocate to work with recipients, that’s okay. The goal is not for the advocate to be from a completely different part of the hospital and not know about transplantation. CMS wants the person to know about transplantation in order to be able to provide help and counseling. A word other than “routine” would have been preferable. It may be possible for CMS to explain that the meaning was intended more like “primarily.” CMS does not want the transplant surgeon, for example, to be the donor advocate. Dr. Hanto agreed that you don’t want someone who is involved in the recipients’ side to be the donor advocate, as they would be likely to be too zealous. It sounds like a donor coordinator, working in the Center and its setting, with occasional involvement with recipients is acceptable. Ms. Newton agreed.
Dr. Reyes asked how CMS will use the community resources to develop the guidelines. Ms. Newton replied that the OPOs will be involved, as they have experience in this area as advocates. Dr. Lorber commented that there is a danger in the balance between an approach that provides advocacy for those who are thinking about being donors, and forcing hospitals on the other hand to use people outside the transplant center to provide this advocacy. The balance could be created in which a member of the transplant team assumes the role of donor advocate and, for that combination of donor and recipient, the person has nothing to do with the recipient. At another time, that person could play the opposite role. As long as they are separated it could work. Can you have true donor advocacy with a staff person who doesn’t know transplantation?
Dr. Wiesner asked about CMS using SRTR outcomes data and whether this will be done independently. Ms. Newton commented that this will be an independent decision. The contract is not with SRTR and the decision about the survey and/or de-accreditation will be made solely by CMS. There will be two surveys: management of the wait list and keeping people informed on the list about their status. Anything that is not an existing outcome measure will be on the CMS survey.
Dr. Scantlebury asked how CMS will assess structural compliance and raised the issue of pain medications not being covered by the recipients’ insurance. Ms. Newton said she had been surprised by a case in which the donor’s medication were not covered; she reiterated that, if CMS pays for the transplant, the donor is to receive services as if he was a beneficiary, related to the donation. The donor’s medications should be covered. However, the medications are not covered for the recipient if the individual hasn’t purchased Part D, when the person is not an in-patient. In terms of assessment, the surveys will be analyzed based on how well the Centers are performing on the outcome measures. CMS will stratify them and survey the under performing ones first. CMS will look at each of the conditions and the evidence that the standard is met. For informed consent, it would be to look for documentation in the records and to ensure that the Center has policies outlining how this is treated. Guidelines will identify this for each area.
Mrs. Boone asked why CMS did not make reporting to JACHO mandatory. Mrs. Newton said that these indicators are sentinel events, so they are voluntary. Death of a living donor must be reported to UNOS, however.
Dr. Conti commented that, in terms of the semantics around the advocate having extensive knowledge and experience in transplantation and in the Center, New York State’s regulations on liver donors includes a well-balanced scheme for the team that effectively describes the idea that CMS is attempting to reach.
Discussion of Workgroup Draft Recommendations Resulting from the November 2006 Meeting
Medicare Part D
Ms. Robinson reported that the workgroup met to discuss Medicare Part D. The workgroup believes there is more information available for patients, providers, and pharmacists, which had been the group’s biggest concern. Resources also are more available from non-profits and other organizations, such as the National Kidney Foundation. It is the workgroup’s recommendation that ACOT continue watching and hearing from people about any problems on which the committee can act. In terms of generic drugs substitution, the group didn’t see a continuing problem. States are beginning to take action and enforcing that the decision is not to be made at the pharmacy level in terms of substituting a generic drug. The workgroup requests that ACOT members be contacted if problems occur, however. Thus, there is no action item for ACOT to consider from the Medicare Part D workgroup.
Dr. Scantlebury reported that the workgroup on public solicitation of living donors has met twice. The concern was over having a system that would ensure the potential living donors are informed about the consequences to his- or herself and to the allocation system. Education is the key. It is the group’s recommendation that a national resource center or other system be created to ensure that education takes place; to establish such a system for education and to conduct a long-term review of living donor’s outcomes. There needs to be insurance that the donors are not being put at risk. The recommendation is as follows:
Dr. Scantlebury noted that elements of the practice guidelines may include: safeguards against monetary exchange between recipients and donors; control of access to potential donor patient information within intensive care units and emergency rooms; insuring that publicly solicited donors are properly informed about all potential consequences of a directed donation for themselves, and for all patients who are waiting; protection against false and misleading statements by those who solicit organs; application of appropriate psychosocial evaluation of potential donors; public education about the importance of supporting the existing, fair allocation system; and a strategy for offering potential donors an alternative when they are responding to a solicitation for a celebrity who is not first on the waiting list.
Dr. Solomon commented that the recommendation does not mention fairness to the living donor, which was in the presentation. She suggested adding a sentence: “and to protect the safety of the living donor,” which was acceptable to the subgroup members.
A motion to adopt the recommendation was made and seconded. There was no discussion. The vote was unanimous.
Mr. Holtzman reported that the work group has conducted several conference calls and has several recommendations. There has been a lot of coverage of this issue and some scandals around tissue recovery, which affects the public’s trust in the transplantation field. The group had consensus on creating barriers/requirements to get into the tissue recovery business (e.g., license, certification, accreditation). It is the group’s sense that one can currently do tissue transplantation in your garage, if you want to, and the members felt that there should be some licensure process. It is estimated that 70 percent of tissues come from OPOs, which are certified. A question is, does one need accreditation from the OPO, American Association of Tissue Banks (AATB), and the Eye Bank Association of America (EBAA). This should be encouraged so that organizations do not have to do all three. At the time being, it is not overly burdensome, but it should be streamlined. It would be good practice and keep bad players out of the business. Recommendations are as follows:
Ms. Robinson noted that the second recommendation does not include inspection; would accreditation take care of this or should it be added. Clarification was that accreditation assumes an on-site inspection, so it’s included. Ms. Principe asked how accreditation, an important process, occurs at AOPO. Not all OPOs are accredited, but 47 out of 58 are accredited. Mr. Holtzman commented that he, personally, felt that they should all be accredited. The process is very detailed and resembles JAHCO’s: three-year process, with an on-site team, standards and management. AATB also has a detailed, although different, process. His view is that they should be combined, over time.
Dr. Vega suggested, in the first sentence, adding “human” before “organs” in both recommendations. He would also say “human transplantation and/or implantation” to avoid confusion.
Dr. Conti commented that the numbers just provided indicate that 20 percent of the OPOs are non-accredited. He asked if there was to be a timeline for these facilities to become accredited, or there is the risk of excluding these OPOs. Mr. Holtzman responded that the OPOs should all be accredited, given the stakes at hand. The workgroup members did not talk about timeframes, but the recommendation will act as an impetus for the OPOs to become accredited, and that’s part of the process. Dr Lorber asked if the OPOs that are not accredited should be able to comment on this requirement before this moves ahead; they may have good reasons for not being accredited.
Ms. Levine, HHS Office of General Counsel, cautioned that both recommendations use “must” and asked if the workgroup was looking for the Secretary to make this a legal requirement. She asked if the recommendation will ask the Secretary to make this a regulation, which would allow public comment and input, or if the group is suggesting that the Secretary seek authority from Congress to do this. Or, is the workgroup asking the Secretary to make a statement encouraging OPOs to become members. Mr. Holzman reiterated the consensus of the workgroup that this should be mandatory. The public comment process would address the need to get feedback, from both OPOs and other tissue banks that are not accredited.
Dr. Burdick asked if, by including organs, an OPO that does not recover tissues would need more than CMS oversight that is currently in place. Mr. Holtzman did not think that would be the case. This recommendation is geared towards tissues, and recognizing that there is no unified accreditation process. This may be a question of semantics. The workgroup’s goal was to get all of the agencies that are recovering tissues and ensure that they are certified by the Federal Government. It is appropriate for the Federal Government to regulate this because the activities cross State lines.
Dr. Solomon suggested removing “organs,” so that it applies to any agency that recovers tissues. So, it would be: “Any agency or organization that recovers tissues for human use”. “Use” is about blood and bone marrow, so we should stay away from that.
Ms. Agrawal noted that the first recommendation is aimed at creating an entry requirement for the field. Revised suggestion:
#1- ACOT recommends that the Secretary seek a procedure by which any entity or organization that recovers tissues for human implant within the U.S. must be registered, inspected, and certified to do so by the U. S. Department. of Health and Human services or its designee.
Dr. Laura St. Martin, a representative from the FDA, commented that the FDA regulates human tissues for transplantation. The FDA is in the process of reviewing current regulations, which have been in effect since May 2005. FDA is reviewing implantation and effectiveness, and assessing how the FDA can resolve some of the issues that have come to light. These discussions on certification have occurred at the FDA, and are being considered. ACOT should not have the impression that nothing has been done, or that nothing will be done. The FDA has a registration process in place and is investigating which facilities are not registered but are doing recovery nonetheless. The scandals have all been about illegal activity, and there are rules in place for registration and inspection. If the word “organ” were to be dropped from the recommendation, it becomes an FDA issue. Dr. Reyes commented that this was the same issue with vascular graphs; there’s a difference between implantation and transplantation.
Dr. Low asked if the recommendation was even necessary and if ACOT should wait and see what the FDA does. Ms. Rosenzweig commented that, if ACOT members believe it’s an issue, then the Committee is adding its voice to the process in which the FDA is engaged; it may help to have experts in the field speak on this issue. Dr. Conti noted that ACOT has not, however, heard reports from organ procurement organizations to assess why that 20 percent is not part of the AOPO; this would be necessary before moving ahead on the recommendation.
Ms. Agrawal suggested that ACOT could recommend that the Secretary express his concern about the need for registration, certification, and inspection for entities that are recovering tissues for human implantation. This is about communicating with the FDA as it goes through the process of looking at regulations, because the scandals and problems affect organ donation as well as tissues. Ms. Conrad commented that she supports the process of making recommendations on this issue. The FDA had an interim final rule for over a decade; the Final Rule still does not speak to the structure, function and non-profit status of tissue banks. There are still concerns in this area. Mr. Holtzman stressed that the FDA does not look at issues such as consent, quality, or who is entering the business. The FDA has admitted that it does not know who is in the business and the ACOT is trying to make a recommendation to the Secretary in terms of creating a barrier for those in the tissue recovery business who are not properly regulated. Mr. Holtzman prefers to keep this issue on the floor at this point.
Dr. Solomon suggested the following edit:
#1- ACOT recommends that any entity or organization within the United States that recovers tissues for human implantation must be registered, inspected, and certified to do so by the U.S. Department of Health and Human Services or other oversight agency, including the Food and Drug Administration.
Dr. Reyes noted that ACOT members do not have all of the needed information yet. If ACOT makes a proposal to the Secretary, it should be based on having all the information. ACOT should work with the FDA on this issue. Ms. Agrawal expressed her sense that the recommendation should go back to the workgroup, and for those members to work with the FDA about what the FDA is doing in this area.
Ms. Levine commented that ACOT is concerned with organs; but because tissue impacts organs donations so greatly, the subject is within the scope of ACOT’s authority. The FDA is within the Department of Health and Human Services, and the Secretary has authority to regulate this issue, which he has delegated to the FDA. She urged the members not to be too concerned about the Secretary versus the FDA. There’s nothing to stop ACOT members from having conversations with the FDA. Ms. Rosenzweig seconded Dr. Solomon’s motion to change the recommendation. Dr. Solomon expressed concern about the current language of the recommendation which could give permission to a foreign organization (e.g., Mexico) to bring tissue in to the U.S., so she withdrew that suggestion. Dr. Lorber commented that anything used in the U.S. is already under the jurisdiction of the FDA. He feels uneasy with what ACOT does not know and encouraged the group to get more information before voting on this recommendation. Dr. Wiesner stated that ACOT also cares about tissue procured or used in the U.S. What is recovered here is a big issue; but a tissue bank in Mexico sending things into the U.S. is also a concern.
Dr. Zhu stated his understanding is that ACOT is concerned with regulating procurement or use in the U.S. If it’s used in the U.S., it should be regulated; but outside of the U.S. use cannot be regulated. Ms. Robinson asked if members could see the multiple revisions presented on a clean hard copy, after lunch. Mr. Aronoff asked ACOT members what additional information they were seeking. Dr. Lorber said that this could include the possible legitimate, contrary views on certification and regulation that might impact how ACOT moves on this subject. Dr. Reyes added that ACOT also needs to work with the FDA to get a sense of what it is including in what it is doing, i.e., how will the ACOT recommendation impact tissue importation. Ms. Agrawal closed the discussion by sending the recommendation back to the workgroup, and asked that the group consider this recommendation later after further discussion and revision by the workgroup, in collaboration with FDA.
Ms. Agrawal noted the workgroup has commented that its members cannot do a significant amount of work before tomorrow to address the issue. Consideration may be given to the recommendation, if time allows, on the morning of May 16.
Economic Impact of Transplantation – Dr. Mark Schnitzler
Dr. Schnitzler discussed the current state of affairs with respect to the economics of transplants. He spoke first about measuring benefits, and then moved on to discuss the health economic valuation of a benefit, economically. He then discussed the four major solid organ modalities (kidney, liver, lung, and heart). Most work has been done in kidneys.
Economists are not concerned only about money but are interested primarily in value. In transplantation and in medicine, there are specific ways to measure value and the transplant community is principally interested in extending life, or making quality-of-life improvements. Relatively speaking, how much we pay for something is a matter of interest to us and, when something becomes too expensive, people change their behavior. We are interested in the cost of caring for a person with a transplant versus not transplanting them at all.
In terms of the effect of transplant, Dr. Schnitzler showed a chart displaying the survival benefit of dialysis versus kidney transplant. The graph showed expected transplant survival and the expected non-transplant survival. The difference between survival with and without transplant is the survival benefit of transplant. One needs many years of data to create such a comparison but, when the data are available, survival can be predicted with great accuracy. Does transplantation extend life? The expected liver transplant benefit was assessed by projecting the 5-year data out to 40 years; the result is a giant area between expected survival on the waiting list compared to transplant. The gain is16-17 years of life benefit, which is large compared to the benefit of other prominent medical interventions.
Looking at life-year benefit by organ, the new lung allocation system may show better effects. Heart and liver transplants are highly beneficial, as are kidney-pancreas transplants. For solitary pancreas transplant in the absence of kidney transplant, the issue is quality-of-life because people survive well on the list and do equally well when transplanted. The average total benefit per donation (if all seven organs are used) is 55 years of additional life from one deceased donor; and average (2002) utilization of organs produces a benefit of 31 years of life. These are large benefits.
Dew, et al, (Transplantation, 1997) reviewed the quality-of-life issue and found that, among 14,000 patients, pre- versus post-transplant, for all studies, for all organs, quality-of-life is improving on a global scale. Further improvements are likely, as care has improved in the last 10 years.
What are we paying for this benefit, and how much do we pay for a unit of benefit? Value = cost/outcomes. We need a framework, though. If something is cost-effective, we have to have a benchmark to decide when something then becomes too expensive. Last year, a New England Journal of Medicine article (David W. Cutler, Ph.D.) gave us an interesting general reference by looking at the effect of medical spending on increases in life span in the U.S overall. The author separated out groups, including age groups, and looked at how much money is spent to gain additional life years in the different age cohorts. From 1960 to 2000, the cumulative change in total life expectancy has increased 10 percent for newborns; and by 24 percent for 65-year-olds, mainly as a result of improvements from cardiovascular disease. For each year of life extension, $50,000 is being spent for each newborn and $150,000 for an older person aged 65 years.
How do transplant modalities fit into Medicare? Extensive literature and research has been done on kidney transplantation. The research clearly indicates that transplant is cheaper than dialysis. One exception is the Mendeloff article (2004), which argued that it breaks even. This is interesting because it’s the only study that’s different. In terms of the cost savings for a kidney transplant, Medicare breaks even on the investment within 4 to 6 years.
Looking at the impact on kidney donor selection, expanded criteria donor (ECD) and donation after cardiac death (DCD) organs account for significant growth in transplant volume, and a deceased donor is slightly more expensive. There is minimal increase in standard criteria donor (SCD) and living donor transplants. The financial structure of kidney transplantation is changing and the average expense of a dialysis patient on Medicare is much more than a transplant case. Extensive data exists for kidney transplantation, thus, refined statements can be made about different events and characteristics and the costs associated with them. Transplantation is cheap if the kidney is stable and functioning; it is more expensive if there is graft failure. Returning patients to dialysis after graft failure is very expensive.
Examples of detailed cost information available for kidney transplant range from delayed graft function (DGF) to gastrointestinal (GI) complications. DGF costs are expensive with the costs being about $134,000 more expensive for DGF patients than for patients without DGF. GI complications are also expensive. The average health care costs were 53.3 percent higher for kidney transplant patients experiencing GI side-effects in the first year post-transplant who discontinued Mycophenolate Mofetil (MMF) therapy, compared with patients remaining on MMF who were free of GI side-effects ($22,694 versus $14,799). Even when MMF was continued, GI side-effects increased costs by $4,601.
Another question is whether there is an effect from pumping kidneys, and what are the costs of doing this. Average accumulated costs for ECD pumped versus unpumped kidneys indicate that pumped kidneys net a savings of $6,000 over the 12 months post-transplant. This data could be used to decide to use the pump or not—doing so has costs. If it is used in ECD kidneys, then the kidney is more likely to be used, which affects supply.
Have we gotten better, and/or improved outcomes? Kidney data show a pattern in reducing the length of stay for the transplant hospitalization in the period from 2001 to 2004, especially in marginal organs compared to standard ones. Medicare’s cost of care is declining.
The data available for livers is much less extensive than what is available for kidneys. Is liver transplant cost-effective at a threshold of some expense? While this is likely, it has not been shown from the perspective of the Federal Government.
Numerous studies have suggested that liver allocation by the Model for End-Stage Liver Disease (MELD) scores increases transplant center costs. It is possible, but not clear that MELD also increases costs post-transplant. We are using older donors, more split livers, and more DCD organs. In terms of donor risk for marginal donors, there is a learning curve for livers and the marginal donor’s length of stay has been affected. We are learning how to handle these recipients.
But, there remain questions about the extent to which clinical outcomes have improved with high Donor Risk Index (DRI) organs, over time, and whether increased center experience will reduce the risk of high DRI organs. We do not know that all high DRI liver transplants are cost-effective. We also need to know if clinical outcomes have improved with high DRI organs over time. The economic impact of high DRI organs may be significant:
As we turn to lung transplantation, even less is known. The literature is tremendously variable on the cost-effectiveness of lungs. It is possible that lung transplant is not uniformly cost-effective. However, the new lung allocation system may have improved outcomes and reduced costs, perhaps yielding more favorable cost-effectiveness ratios. With hearts, there is more literature. The numbers vary, but they are within the range of cost-effectiveness.
Looking at cost curves, an analysis (by Schnitzler) of costs before and after transplant yields several examples with slope of costs is lessened after transplant. For kidney transplants, there is a steep slope of costs before transplantation (the costs shown are for a private health plan). Projecting pre-transplant costs forward indicates that the break-even point for kidney transplantation occurs quickly because patients are much less expensive after transplant than on dialysis. The private insurers in Dr. Schnitzler’s example pay approximately three times more than Medicare for the care of patients before kidney transplant, thus financial break-even occurs sooner for private insurers (than for Medicare), making it beneficial for the private insurers.
Heart transplant costs in the private insurance sample show a huge increase of costs just prior to and through the end of the transplant hospitalization. These costs lessen dramatically when the patient leaves the hospital. Thus, there is great potential for cost savings in heart transplant by adding organs and reducing the average duration of wait. In the 4 months before the transplant occurs and until the patient is stabilized, costs total approximately $600,000. If the wait can be shortened, these costs can be substantially reduced.
In the lung transplant sample, private insurance spent $1.1 million from listing through 4 years post-transplant. If waiting time can be reduced, this again has the potential to save a great deal of money because much of the costs are incurred in the last months of the wait.
Liver transplantation is less expensive for private insurance prior to transplant than kidney transplants. This is mainly due to the absence of maintenance therapy for end-stage liver disease patients while patients with end-stage renal disease have dialysis. It is unlikely that liver transplant is cost saving due to the low pretransplant costs. However, liver transplantation is almost certainly cost-effective due to the large survival benefits.
HR 710 was introduced in January 2007 to address the possibility that paired kidney donation might be interpreted as violating the National Organ Transplant Act. The bill clarifies issues such as that paired donation is explicitly legal. The bill was passed after the Congressional Budget Office (CBO) released an analysis stating that kidney transplants save public money, as much as half a billion dollars over time. The lesson is that it is very useful if the field can demonstrate the cost saving aspect of transplantation.
In summary, solid organ donation extends lives. Kidney transplant produces cost savings. Non-renal transplants may offer cost savings, but more data are needed. Kidney economic data have facilitated passage of the donor swap law, several extensions of immunosuppression benefits, discussions of LD compensation, facilitated assessment of machine preservation and other technologies, aided in the assessment of ECD/DCD financial implications, and demonstrated the economic value of avoiding complications. Yet, the field is far behind kidneys in the other organs.
The big economic question turns around the economic effects of organ supply expansion. If there are cost savings from organ supply expansion, who are the beneficiaries (e.g., Medicare, Medicaid, the VA, private payers, and/or patients)? What is an appropriate investment in organ supply expansion? And, finally, are we under-investing in this expansion?
Dr. Reyes asked about the lack of cost-benefit analysis in livers versus kidneys and if this resulted from the use of dialysis in kidney failure (whereas liver patients tend to die more quickly). Another way of asking the question is if it is more cost-effective if the patient dies quickly. Dr. Schnitzler responded that huge amounts of money are spent on patients who die and that it’s the dialysis that makes it happen for kidneys. There also are other expensive support devices that are not available for livers.
Dr. Wiesner asked if there had been an assessment of livers before and after the use of MELD. Dr. Schnitzler replied that globally there’s very little information on liver patients. Studies have looked at transplantation pre- and post-MELD. These are almost all single center studies that have shown that post-MELD costs are higher. This could be a time effect, however.
Mr. Frieson commented that it is more expensive with ECD and DCD donors, and asked if medical directors ought to look at selective criteria for the donors? Dr. Schnitzler replied that, if a Center is running on the bottom line alone – and is not concerned with volume (in other words, they are only doing profitable transplants), then yes. He has not met any surgeons like that. But it is possible that they exist and that they would skip ECD/DCD, and take SCD offers. Centers make more profit on patients who remain on the waiting list than from those who are transplanted.
Dr. Migliori said that, in looking at the costs of the last 12 months of life, it is amazing how much it costs if the patient is not transplanted. As an insurer, however, it’s not about the economics. The insurer’s obligation is to apply evidence-based medicine. Congress needs to know this, so it can understand the benefits and the specific dollars that would be spent.
Ms. Conrad asked Dr. Schnitzler to expand on the remark that we are grossly under-investing and why he had not said, instead, that we are over-spending? The answer was that this is a good investment and should be expanded. The Organ Transplantation Breakthrough Collaborative costs several million dollars, about $1,000 per organ, and is the sort of effort to improve acquisition rates to which Dr. Schnitzler was referring.
Ms. Rosenzweig suggested that the cost savings argument could be applied to the concept that Medicare should provide immunosuppressant drugs. The CBO has stated that it will cost money to cover immunosuppressants, so a convincing argument that doing so will save money is needed. The CBO scored the bill as a half billion dollar savings, which was given to Part D. This was a missed opportunity to invest those savings into beneficial activities connected with organ transplantation. Dr. Scantlebury suggested looking at the costs to the system of patients returning to dialysis at 36 months for the Medicare system compared to private payers, as the latter might offer immunosupressants. The problem is that private payers do not really know who is uninsured or not, while we do know who the Medicaid beneficiaries are.
Kidney Allocation Policy Under Development – Dr. Leichtman
For the last 3 years, the OPTN has been working on integrating a measure of incremental Life Years from Transplant (LYFT) into the SCD kidney allocation system. It held a year of hearings, which identified three principal concerns: the shortage of donor organs; the possibility of improving the allocation algorithm; and geographic constraints. The OPTN Board of Directors, noting that HRSA was working through its “Collaboratives” on initiatives to improve donor availability and that issues of geography might be so divisive as to prevent the development of consensus around a new allocation system, directed the OPTN Kidney Committee to concentrate its efforts upon developing a new kidney allocation system, The kidney committee considered multiple alternative allocation strategies, and decided with the endorsement of the OPTN Board of Directors to focus on developing an allocation system that would integrate a measure of LYFT into the kidney allocation algorithm.
The OPTN Final Rule directs that policy development should seek “to achieve the best use of donated organs”; be “designed to avoid wasting organs”; and set “priority rankings through objective and measurable medical criteria.” Nearly all types of chronic renal failure patients are predicted to live longer with a kidney transplant than without (dialysis alone). Some types of patients are predicted to gain more LYFT than others. Kidney transplantation provides both a better quality of life and longer life. For most candidates, receiving a (SCD/ECD) kidney transplant yields improvements in survival at every age, compared to remaining on dialysis without receiving a transplant.
The Scientific Registry of Transplant Recipients (SRTR) in collaboration with colleagues from the OPTN Kidney Committee has developed methodology for estimating and modeling LYFT. LYFT is the difference between two predicted lifetimes: first, the expected lifetime without a transplant; and second, the expected lifetime with a transplant from a specific donor. As example, for a hypothetical 30-year-old (who is otherwise average), the candidate’s remaining life might be 18 years with a deceased donor kidney transplant, and 12 years with dialysis. Her LYFT is 6 extra years. This hypothetical candidate’s LYFT would be greater if her expected survival on dialysis was shorter, or her post-transplant life would be longer.
LYFT combines two major approaches to organ allocation (medical urgency and post-transplant survival), and prioritizes both using a common metric of expected future years of life. LYFT can be used as an element in organ allocation; as a metric to assess trends in outcomes of the current allocation system; and as a metric to compare the current allocation system to proposed alternative allocation systems.
The trend since 1995, using the current allocation system, has been one of declining post-transplant life spans. Average post-transplant lifespan for recipients of SCD kidneys has fallen to about 12 years from about 14 years. There is also a decline in recipient’s LYFT from 6.7 years to 6.1 years. This shift reflects a decline in SCD organs going to recipients under age 50, from 63 percent to 47 percent. People who are being added to wait list are older (65 or older); and there is less growth among the younger kidney transplant candidate populations.
There are choices in the way LYFT can be calculated. One can use median survival based on post-transplant donor and recipient characteristics (this is stable to estimate and median follow-up is nearly complete); truncated lifetime (these data are stable but follow-up for many candidates would be incomplete); or average survival (these data are less stable, due to people living so long that it’s necessary to project significant fractions of their potential lifetimes). Median dialysis and post-transplant survival can be estimated for most candidates and recipients from existing data. There are also other methods that use different weights for lifetimes by prioritizing quality-of-life considerations, emphasizing urgency, and/or discounting future years. For quality-of-life (QoL) considerations, we use a mixture of years with and without a functioning transplant, weighting the years with a functioning transplant at 1.0 and discounting the years with a non-functioning transplant at 0.8. All of the following simulations use QoL adjusted LYFT. The survival models are based on covariates from the OTN database that are available, quantifiable, important, and non-gameable including: age, transplant type, diagnoses, body mass index and donor factors.
When we consider the median LYFT by candidate’s age and diabetes status, the highest median LYFT scores are found among younger diabetics awaiting simultaneous kidney and pancreas transplantation and among younger nondiabetics; however, there is considerable overlap in median LYFT scores among all classes of potential candidates. The individuals who overlap would be competing for the same organ(s). There is little difference in the ranges of LYFT scores by race and ethnicity, gender, or insurance status, or by diagnosis among non-diabetic candidates for kidney transplantation..
In summary, LYFT based upon estimates of median lifetimes can be calculated using available information about the potential recipients and the available donor. This calculation requires extrapolation for fewer than 3% of candidates to estimate dialysis lifetimes, and 26% of recipients to estimate post-transplant lifetimes. Variables in the predictive models are selected based on their availability, predictive value, data quality, and objectivity. Dialysis years are weighted to 80 percent of years with a functioning transplant. LYFT varies greatly (range of 1-15 years with an average SCD organ) among candidates, primarily by diabetes and age LYFT is similarly distributed by race, ethnicity, gender, and insurance type.
Simulation models have been generated using the Kidney and Pancreas Simulation Allocation Model (KPSAM). This is a sophisticated computer program that can replicate the results of the current kidney allocation system; predict the consequences of proposed policy changes before they are instituted; and allow comparisons between alternative allocation rules or algorithms. KPSAM uses specified national (e.g., no local or regional alternative systems) allocation rules and the characteristics of actual candidates and donors. The order of offers of organs to candidates is based on the allocation rules being considered. Data from actual candidates and donors are used to predict the candidate, recipient, and allograft outcomes, as well as the probability of an offer being accepted. Outputs include survival outcomes and demographics of recipients resulting from application of the rules under consideration.
Dr. Leichtman stated that the SRTR modeled the current and possible alternative deceased donor kidney allocation systems using KPSAM to assess the potential consequences of a number of possible rule changes. There were three classes of models compared for the allocation of the actual available SCD organs to the adult waitlist population from 2003. First is the current system; second is a system that substitutes a LYFT score for the current kidney allocation points; and third is a system that both uses LYFT instead of the current point system and modifies the current allocation system in additional ways (specifically, it eliminates payback, eliminates zero HLA-mismatch priority and sharing, and nationalizes allocation of Blood Types A2 and A2B donors to Blood Type B candidates). The current system is estimated to generate 113,541 life years. Using the second method substituting LYFT for the current system of kidney allocation points is predicted to increase the life years by 25,793 life years. Over a 1-year period, it increases the years of graft survival by almost 10,000, and increases the extra life years attributable to transplantation by 11,457. When comparing the current system with the third system, even more years of life and incremental graft survival may be gained.
No change in distribution of organs among races and/or ethnicities is predicted from these models. In terms of diagnosis, there is expected to be an increase in access for candidates with polycystic kidney disease, and a large decrease in transplantation among older diabetics. Looking at age, in the current system there is a large steep peak at about age 55. In a LYFT system, there would be a broader peak from ages 20-59. Looking at the distribution of recipients’ post-transplant years lived at each age, the distribution of the age changes. There is a large predicted increase in years lived, when compared to the current system, among people under age 55, and a smaller but probable decrease in years lived among recipients over the age of 55.
For KPSAM models incorporating LYFT into the kidney allocation system, when compared to the current system, SCD kidney allocation incorporating LYFT would have little effect on the racial and blood type distribution of recipients. It would shift kidney transplants towards younger candidates, non-diabetics, and lower Panel Reactive Antibody (PRA) candidates; and, it would increase the percentage of higher LYFT recipients. If allocation of SCD kidneys were primarily based on LYFT, rather than waiting time points, simulations suggest that after a single year’s worth of transplants involving (ECD, SCD, Simultaneous Pancreas-Kidney transplantation) deceased-donor kidneys: total extra life-years would be increased by over 11,000 years (26%); total years with a functioning graft would have be increased by over 9,000 years (12%); and the average extra years of life per transplant would be increased from 4.7 to 5.9 extra years of life (26%). These are “what if” scenarios and are part of the model efforts that the SRTR performs to support the OPTN policy development process. The OPTN and SRTR are also looking at strategies to change the allocation system in order to achieve other end points, and will also in the future, model the costs in life-years of these additional potential changes in the kidney allocation system.
In conclusion, allocation incorporating LYFT is not a zero-sum game that would solely shift years of life from one patient to another. Allocation incorporating LYFT could potentially increase the total years of life that could be achieved from the existing deceased donor pool and save incremental patient years of life. Allocation incorporating LYFT is currently under discussion at the OPTN Kidney Committee and throughout the national transplant communities as well.
Dr. Scantlebury asked if, when SRTR looks at life years for diabetics, Type 1 and 2 are separated out. Dr. Leichtman responded that’s not possible, but SRTR does look for those who are listed for simultaneous transplantation or not. Dr. Scantelbury noted that African Americans have a shorter half-life for kidney grafts than do other groups, so an African American patient getting a kidney isn’t expecting it to last 15 years. How would SRTR calculate the life years for such an instance? Dr. Leichtman answered that African Americans on the wait list are much younger than Whites who are on the list. When we compare patients at the same age, Whites have longer graft survival, but for those on the list in general, it’s not the same situation because youth offsets the potential long-term graft survival. Who the recipients are would be shifted to the younger African Americans, although older African Americans might be at a disadvantage. Currently, African American’s access is only two-thirds that of Whites. If a system perpetuates this current disadvantage, it’s not an improvement.
Ms. Principe asked if the oversight aspect (monitoring the system) had been factored into these discussions. Dr. Leichtman responded they are all concerned with trying to simplify the structure. Complexity is a question that we struggle with—the current system is complex and few understand how it works. The goal is a system that is more transparent. The potential for LYFT is that everyone receives a score based on a “standard” organ. The patient would know if they are better or worse than a consistent average. There is a benefit to being able to counsel people on something understandable, so they can make better health decisions.
Mr. Holtzman commented that there are lots of issues about allocation nationally. There are organ-rich and non-organ rich areas, for example. He asked if the potential changes have been modeled regionally to see what happens. He also asked if there had been any push-back from advocates of older patients, such as the American Association of Retired People. The reply was that this is not a proposal; it is merely a “what if,” about something that will not be proposed. Certainly, we all recognize the necessity for a good rationale for a system with clear winners and losers like this, and it’s hard to see what that rationale would be. In terms of national allocation, there are currently varying levels of access to the wait list and to opportunity for organs. There are two ways to shorten waiting times: by improving care or increasing the number of organs available. After MELD had been operating for a couple of years, it was clear that people with very different MELD scores were getting organs, and some people with very low MELD scores were getting organs, based on where they were geographically. That will probably also happen with LYFT scores and would probably necessitate revision of the allocation regions.
Dr. Reyes asked about the post-transplant benefit showing up at 4 years post-transplant. Dr. Leichtman commented that some patients are on dialysis for a long time; the actual age may not reflect the number of years they have been on dialysis. Dr. Schnitzler added that economists think of the life-year benefit as different from LYFT (it’s 1.7 x LYFT). LYFT measures median survival or life expectancy. It’s easier to explain it to people, than “life years.” The costs and break-even times do not assume that everyone survives; they include deaths and their costs, as well as costs of caring for those on dialysis. The 1.2 years is the change in LYFT score: the difference in the number of years they are likely to survive with a transplant versus staying on the wait list. How many years will a person survive with a transplant is another question (and also survival with a second transplant).
Dr. Wiesner asked about ECD donors, and whether one would use a score? Dr. Leichtman reiterated that this is not a real system. In a system that was going to occur, which this isn’t, one could use the quintile system -- all organs are in one bucket and split into quintiles, then allocated along a match to the quintile of the candidates. The OPTN Kidney/Pancreas Committee members like a different system, which is to have a donor risk index, and match the least/best good donors with the least/best good organs. SRTR’s role is to help understand the consequences of policy proposals and to model such proposals.
Paired Exchanges: Update – Dr. Dorry Segev
Dr. Segev gave an overview of kidney paired donation (KPD), discussed simulations and optimization of paired donation, described the national implications and new concepts in expanding KPD, provided an update on both the Johns Hopkins and the national experience in this effort, and discussed progress towards a national KPD program.
Incompatible donation is defined as a live kidney donor and his/her intended recipient who are either ABO incompatible (ABOi), or have a positive crossmatch (+XM). There is a 35 percent chance that any two individuals will be ABOi; and an 11 percent chance that they will have a positive crossmatch. There is a much higher +XM for patients who are sensitized due to previous transplants, pregnancies, or blood transfusions. In live donor paired donation, incompatible pairs exchange donors with the result that compatible transplants can occur. These donor operations are performed simultaneously, to avoid cancellation by one donor after another donor operation has already started. Currently, in most programs, donors and recipients travel to one center, or donors travel to the recipients’ Center.
Johns Hopkins started with conventional, paired donations. That limited the Center to AB and BA pairs, so patients with positive crossmatches were added. This opens the doors to all blood type combinations; it’s possible to have three- or five-way paired donations. One question is how many patients join the deceased donor waiting list because their only willing live donor was incompatible? In the Netherlands, there is a national donor exchange program that in, its first year, had 62 pairs joined. A similar percentage in the U.S. is the equivalent of enrolling 1600 patients with the anticipation of transplanting 700 of them.
In a simulation of live incompatible donors, there are several key questions. How many donor/recipient pairs each year would be eligible for KPD? What is the optimal algorithm for matching them? What would be gained by a national system? What is the role of List Exchange?
How many eligible pairs would be eligible? A simulated work-up like what would occur in the clinic setting was run. The numbers are high - between 2,000 and 4,000 patients would be expected to be listed in this group. This is not far off from the numbers the Netherlands saw in the first year. Now we have a simulation but how do we match them? It’s important, because there are one million ways to match 100 incompatible pairs. We used optimization technology, which can quickly and efficiently consider all solutions to a given problem, and pick the best one. Blood type distribution makes the most difference; A donor to an O recipient has fewer options, for example. Graph theory was used to represent the clinical information about donors and recipients in a way that could best be processed for matching. Algorithms to match people in the graph were used. Otherwise, a review of chart by chart is necessary to see if the pairs are compatible and then do the transplantation. This system uses math to find matches and to optimize the number of transplants that can be done. Match opportunities can really be affected here, as every choice affects opportunities for other transplants.
Second, what is gained by a national system of doing this rather than organizing it in a single center? The larger the number of people in the system, the more matches can occur. Simulations show that an optimized system is better than a first-accept system. When you expand from a single Center to regional and then to national programs, there are 11 percent who can be transplanted in Center, compared to 33 percent regionally and 42 percent nationally. There are big gains to be made from moving up from regional to national systems. Highly sensitive patients are very unlikely to find a match in a single Center. Regionally and nationally, there are huge increases in matches from expanding the pool, with over 60 times as many patients predicted to match in a national system when compared with a single-center system. With moderately sensitized patients, there are also dramatic improvements; a lot of them are blood type compatible but Human Leukocyte Antigen (HLA)-incompatible, and their donors can give to harder-to-match blood types. Increases jump from 25 percent to 75 percent in a national system.
The role of the list exchange is to bump the recipient to the top of the waitlist when the recipient’s donor gives to the next available person for his/her specific compatibility. The recipient who brings forward a live donor gets a deceased donor organ. Operations are not simultaneous; the recipient must wait for a deceased donor organ after the live donor has already donated, meaning that it is not scheduled and the wait can be lengthy. People can die or get sick while waiting. There is no reciprocal match required (deceased donor and waiting list pools).
In an article in the American Journal of Transplantation, Dr. Frank Delmonico pointed out that highly sensitized patients are excluded from the system because of the long waits. There is an ethical dilemma in this system for O recipients with non-O donors. The O list is hurt by the deceased donor organs going to the recipient; the A list benefits. A simulation was run to see which patients are eligible and can be matched. List-paired donations work better in smaller pools; but when the pool size grows (as it would in a national system), there are more transplants up-front from a live-paired system.
So, given all of that, there are new concepts for live donor paired donations. Contrary to the original definition, pairs do not need to be incompatible donors to benefit. Altruistic donors can participate to create compatible pairs that might gain something else. Altruistic donors are put through domino-paired donations that make two or more transplants possible which makes non-directed donors really excited. Because there’s no reciprocal match requirement, pairs who were otherwise difficult to match in a given incompatible pool are much more likely to match with an altruistic donor.
In terms of expanding match opportunities by matching compatible pairs, it originally was thought that, in most situations, it would only work when compatible pairs come forward altruistically. However, there are 45 percent of compatible pairs simulated from UNOS numbers that would gain medically from the paired donation. Only 15 percent are purely altruistic. Another advantage is that O recipients benefit dramatically from this system.
Remember that the original definition said that compatible transplants result from the paired exchanges. However, one doesn’t necessarily need to find a negative crossmatch in KPD; one can combine KPD and desensitization. In any pool of recipients, many will not match. The hard-to-match pairs will accumulate; most of them are broadly sensitized. The results with desensitization low-titer positive XM transplantation are excellent. For broadly sensitized patients, the Johns Hopkins program has changed from finding a compatible donor to finding a better donor. Of 43 patients, 13 couldn’t desensitize with their original donors, but were low enough titers with their matched donors to be amenable to desensitization.
The last change in the original definition is that the donor or recipients have to travel to the center where the transplant has been arranged. In fact, shipping organs by plane is common for deceased donations. Because of concerns about cold ischemia times, however, this isn’t done for live donations. This, however, would be an issue in a paired donation system. We looked at UNOS’ database on live donors and found that there was no statistical significance or clinical significance in outcomes when cold ischemic times were increased. Two weeks ago, we took a live donor kidney that was available in San Francisco and brought it to Baltimore, where it was transplanted immediately at 11 pm. More than 8 hours of ischemia, but we had immediate graft function and normal creatinine in 3 days. The recipient is doing well. Our view is that we should allow live donor organ shipping.
At Johns Hopkins, we have done paired donations of this sort with 43 patients. The results, in a pool of broadly sensitized patients, include no grafts lost to antibody mediated rejection and two deaths with functioning graphs post-transplants for other reasons. In terms of the national experience, there have been 180 patients transplanted in this manner over a 7-year period. There are two multi-state consortia created to do this, but only two Centers have conducted more than 10 transplants with paired donations.
Dr. Segev feels personally that one reason we don’t have more participation is that there is a lack of oversight, and the legitimacy of something run by UNOS. UNOS has a policy out for public comment for this process. Permission that paired donation is legally permissible has been received from the Department of Justice (DoJ); and the current congressional legislation, the Living Kidney Organ Donation Clarification Act of 2007, is currently in conference committee.
In conclusion, KPD offers a novel solution for patients with willing but incompatible live donors. The clinical outcomes from KPD transplants are excellent. Johns Hopkins’ simulations suggest that thousands of patients each year would be eligible for KPD. These predictions correlate well with real data from the Netherlands, where a national KPD program is in place. An optimized matching algorithm significantly improves match rates. A national KPD program increases opportunities for all patients, especially for those who are highly sensitized. Most patients who would be eligible for list exchange would match in a KPD program of moderate size.
Some of the travel barriers to regional or national KPD programs might be eased by shipping organs. By expanding the system to allow compatible pairs seeking younger donors, altruistic donors, and highly sensitized pairs willing to accept desensitization with low-titer positive crossmatches, the opportunities for matching will grow significantly.
Ms. Levine confirmed for ACOT that on March 28, 2007, the DoJ Office Legal Counsel issued a legal opinion on this, concerned with “valuable consideration.” DoJ concluded that paired exchanges do not involve “valuable consideration.” Paired exchanges and deceased donations are both exempt from this limitation. The opinion is binding on the Executive Branch, which is the branch that would prosecute under the National Organ Transplant Act (NOTA). The ruling stated that the prohibition is mainly for “pecuniary gain [that is] readily convertible into monetary value” (see the DoJ website for the full text). The Division of Transplantation was not going to facilitate a nationwide system on kidney paired donations until there was a decision about NOTA. Congressional action was very similar; both exempted kidney paired donations. Ms. Levine has not heard any progress on the congressional bill’s movement through its conference committee to become a Federal law.
Mrs. Boone commented that her first thought was that here is another way to increase living donations without any long-term follow-up. She asked what would happen if a very sick patient came with a willing donor, but they didn’t match, and were put into the pool and then matched to another recipient, and the transplant performed. What would happen if, during the waiting time, the patient’s health deteriorates to the point where he/she can’t have a transplant? Dr. Segev noted that this is the biggest disadvantage of the list exchange, when transplants do not happen simultaneously. For that reason, the transplants are done all at once; there’s no time to get sicker while waiting for a match.
Dr. Hanto commented that it’s still necessary to evaluate people and that takes time. Recipient selection criteria will be the key; the donor has an interest in knowing something about the recipient being appropriate and not high-risk. Dr. Segev replied that most of his experience with donors who do not know their recipients come from non-directed donors (e.g., altruistic donors). These donors are just as interested in the high-risk, vulnerable patients as they are in the patients for whom the donation may last longer. In paired donation, the donor really thinks of it as them giving the organ to the person they are connected with, because they helped make it possible, rather than thinking of who is getting a specific organ. We keep it anonymous until a week afterwards, and we only let them meet if they all agree (they all have agreed to meet so far).
Dr. Scantlebury asked how people handle it if the recipient does not do as well as another recipient. Dr. Segev said that donors always wish it had gone better when a donation goes badly. People who enter paired donation have two choices: they enter and get a donor; or they wait (potentially for a long time) and get a deceased donor. You always do better the first way and they all understand that. There are many discussions about the differences in outcomes among different people; they are all familiar with this. They are not disgruntled that the outcomes vary.
Dr. Wiesner asked how they handle it when someone reneges on a donation? Dr. Segev said all of the donations are performed simultaneously; they are scheduled all at the same time. It’s never happened, for someone to renege. Mrs. Boone asked if each of the donors and recipients has his or her own advocate team. Dr. Segev replied that they have advocate teams on both sides, as well as a team of coordinators for the program because of the special nature of paired donation. Each pair is treated as a pair, not as four patients; they all get their own advocates.
Dr. Segev closed by encouraging the oversight of a paired exchange program by the OPTN, including research funding of paired donations.
Scientific Registry of Transplant Recipients Activity Report – Dr. Fritz Port
The Scientific Registry of Transplant Recipients (SRTR) serves the ACOT to conduct analysis; SRTR is funded by the Health Resources Services Administration (HRSA). HRSA funds both OPTN and SRTR, in two separate contracts. The two entities have different – but complementary -- goals and missions. SRTR’s mission is research and policy evaluation; SRTR’s data responsibilities are concerned with inferential analysis and simulation modeling. The contractor is Arbor Research.
Looking at an organizational chart of the national transplant system, SRTR has a technical advisory committee that reviews the statistical methods. CMS also uses the data and the Center-specific reports and OPO reports. Arbor Research is a non-profit organization that is not actually part of the University of Michigan. The team includes: biostatisticians, epidemiologists, medical physicians and surgeons. At least one principal (a Clinician or Biostatistician) and one analyst are assigned to the 20-plus OPTN committees. These teams provide the data analysis on which the committees base decisions about policy changes and modifications. Additional SRTR resources are utilized as needed and provided for in the SRTR contract. Not every request can be accommodated, however. When requested analyses require more resources than are available, the SRTR works with the OPTN and HRSA to prioritize the analytic work to be done.
SRTR’s main responsibilities are: perform ongoing evaluations of the scientific and clinical status of solid organ transplantation; to provide research support to the OPTN Board of Directors, OPTN Committees, HRSA, the ACOT, and the scientific and transplant communities; to develop and publish Center-specific and OPO-specific reports; to make annual reports on the status of solid organ transplantation; and to draft biennial reports to Congress.
The SRTR combines two transplants in the same patient to capture that the person had two operations, so the transplants are not seen as two events. They make sure that those who are recorded as “lost to follow up” are really deaths – SRTR now finds 99 percent of deaths. Some Centers actually have better outcomes when the lost-to-follow-up cases are identified. The system is more complete now.
As an example of the statistical methods used by the SRTR, common uses of the survival analysis include modeling time to event for outcomes such as transplantation, death, or allograft failure; examining factors that influence outcomes for transplant candidates and recipients; comparing outcomes of various sub-populations; and evaluating risks associated with factors that are updated over time (e.g., MELD and Pediatric End-Stage Liver Disease [PELD] and their underlying components). These statistical methods are useful for allocation policy considerations. Another type of analysis for organ allocation is to look at acceptance of the offer. SRTR data analysis can show what decision will result in the best outcomes.
Simulation Allocation Models (SAMS) can be used to predict the effect of policies on relevant outcomes before policy implementation occurs. What happens in this case is that SRTR uses all of the people on the waiting list at this moment, and compares the outcomes with different rules (for example, this is what Dr. Leichtman presented on in his LYFT discussion earlier). Allocation methods are primarily compared on the basis of the number of transplants and deaths by patient subgroups. The lung allocation was changed as a result of such an analysis from a system that was waiting time-based, to one that was not based on waiting time. Many other summaries are also produced, such as organ discards, re-listings, graft failure and sharing. SRTR also provides analytic support for policy committees. Policy development is a collaborative process, but OPTN coordinates the policy development work (other interested parties include the Centers, OPOs, SRTR, OPTN, HRSA, ACOT, patients, and the public). SRTR provides ongoing development of statistical, analytic, and simulation models that are responsive to the goals of policy development. SRTR’s approach has been to examine the big picture first, then explore the details. Analyses should be carefully designed to address specific aspects after broad policy questions have been answered.
SRTR goes beyond the existing data and conducts extra ascertainment that uses other available data sources (e.g., SSDMF, NCHS, CMS, SEERS). A sampling approach is taken rather than a complete census, and they recognize that serial data may provide information not available at the baseline. Cost versus value is explored, and changes in allocation policy are evaluated before implementation. OPTN has implemented policy changes based on SRTR analyses, including removing points for HLA-B matching (with the effect of improved access for minorities and kidney graft survivals); the MELD 15 Rule (a regional offer is made if no local candidate has a MELD over 15, with the result of improved geographic distribution and transplants with higher MELD); and allocating lungs by urgency and transplant benefit (with the result of reducing the waiting list and time). These changes have had important impacts.
Center-specific reporting is conducted every 6 months. SRTR looks at the norm, and assesses what is standard for your waiting list and the national average. Is the patient better or worse than this outcome? Different audiences have different questions, so SRTR uses different statistical models for them. Patients and families want to know what will happen, what their survival rates are, etc. The OPTN Membership and Professional Standards Committee and Payers (CMS) want to know if the Center is performing up to standards, or systematically failing to do so. The Transplant Centers want to know how well they are doing, what choices their patients have and what information they can use to discuss waiting time and survival with patients. To help answer these questions, SRTR creates many different kinds of reports and information including center-specific reports, quarterly reports to the OPTN Membership and Professional Standards Committee, etc.
The user-friendly “landing page” for the center-specific report shows data in terms of the national scale. It also provides the percentile for many indicators. It is possible to use this page to see where a Center is in comparison to the standard -- or expected -- outcomes. One also can click through for more detail. Transplant Center measures include post-transplant survival (e.g., grant, patient survival). New ways to flag small Centers and wait list measures (organ offer and acceptance rates) are being considered. Only about one-third of the Centers look at their report before it becomes public, which is a surprising low number.
The CD provided today includes information on how to request data and Standard Analysis Files (SAFs) from the SRTR; program-specific reporting information (such as slideshows on how statistics are calculated and documentation of statistical procedures and model choices for Center-specific reports and OPO-specific reports); OPTN/SRTR Annual Data Report Reference Tables; and the American Journal of Transplantation SRTR report on the state of transplantation articles, slides, and slides from other SRTR publications.
In summary, numerous analyses from SRTR serve the OPTN committees, HRSA’s Division of Transplantation, and the public. The Standard Analysis Files are available for researchers. Program-Specific Reporting is conducted for internal quality improvement, surveillance, and patients. SRTR creates OPTN/SRTR Annual Data Report, and Reference Tables. The SRTR Web site has information such as the annual report, Center- and OPO-specific reports, transplant articles, and slides from other SRTR publications.
In the future, Center-specific reports will become more user-friendly. They will highlight a range of basic aspects of transplant center “performance” and provide multiple important concepts on the initial page. Some users will need to move from the less detailed information to the source and methods, so the capacity is being built to drill-down for more detail, and more complex analysis. The SRTR also is working to allow “drill-up” from detailed center-specific report tables to these table-specific overviews, which will allow users to explore more detail of each specific statistic, and understand how it is calculated and interpreted.
Dr. Scantlebury asked if, when assessing outcomes, SRTR looks at the recipient population to factor it into outcomes — if they have more African American or Medicare beneficiaries, in other words. Dr Port said that SRTR looks specifically at this, and then modifies the national data so that it can see what the outcome would be expected to be, if the Nation looked like that Center’s population. This is done separately for the wait list and for recipients.
Dr. Conti asked if the data are checked or if they are dependent on what is provided by the Centers. The answer is that OPTN provides the data; SRTR does quality checks and give the results back to OPTN for follow-up. Also, there are other data sources that are used, as well.
Dr. Wiesner asked for comment on the data reduction issue; he questions the accuracy of the data on kidney graft failure from alternative sources. Dr. Port stated that more data are better. SRTR has another data source and can avoid data collection burden for the Centers, namely deaths data; it does not rely on the Centers to capture the death form. If we can show that the combined OPTN and SSDMF data give us the same information as SSDMF alone, why get the first set of data from centers on kidney graft failure? Failures of other organs can be captured by data on retransplantation (which SRTR gets from OPTN), and data on deaths come from vital statistics, although we are not capturing the cause (CVD, tumor).
Dr. Zhu commented that the work, especially the statistical modeling work, is impressive. He wondered if SRTR or HRSA has ever looked at third party, independent verification of the quality of analysis, given that there is a monopoly of information and models. Dr. Port answered that HRSA actually asked the same question. HRSA’s Division of Transplantation convened two separate technical expert panels: one on simulation, and one on statistical methods. They both came through with flying colors. SRTR has a technical advisory committee with technical experts in simulation modeling or biostatistics that also critiques the work. Dr. Port hopes that the monopoly is of experience, not of information.
Dr. Vega said that the analysis of post-transplant survival does not adequately include donor factors, especially for heart. Dr. Port replied that they would love to do this and agreed that it’s very important. The liver is the best, in terms of donor factors of liver donation. The OPTN Thoracic Committee is working with the SRTR on the heart, which is the least developed right now. More data is needed to be able to do this, though. Dr. Vega asked why, with an average survival for heart being more than 10 years, we don’t have 7-year survival data. Dr. Port agreed that SRTR needs to show ACOT, and others, more data for longer follow-up. The problem is that there have been changes in methods and technology (drugs, devices), and the SRTR would need to extrapolate from this.
An audience member spoke, commenting that she was a liver donor in 2001, and is on the OPTN Living Donor Committee. She raised the paired exchange coverage on a recent Discovery Channel program, which showed a three-way exchange and described that two of the three recipients were not eligible for DCD. Yet, they got a living donor. Is that the case where the criteria would be different? Dr. Segev replied that Johns Hopkins gets a lot of desperate people who are so medically fragile they can only get through a transplant when we can guarantee them immediate kidney function. With most DCD, there is at least some delayed graft function, so they are not good candidates for the deceased donations. That’s the situation. There are people that Hopkins has turned down for deceased donations who have been accepted for live donors using paired donations. Everyone was aware about the situation and how sick the recipient was; they are told about the realistic risk of death.
Mrs. Vicky Hurewitz said she thought that a transplant candidate had to be listed before he or she could get an organ. Dr. Segev reported that that this is not the case. Mrs. Hurewitz asked about the makeup of ACOT and commented that it seems as if Mrs. Boone is the only member who isn’t in the industry. With Mr. Hagman rotating off ACOT, she asked if there will there be another public member. Ms. Robinson noted that she is not in the donation industry, but is a donor. Mrs. Hurewitz suggested that Ms. Robinson made her living from the organ transplantation industry, which Ms. Robinson refuted. (Several other ACOT members indicated that they did not make their livings from organ donations.) Ms. Agrawal reported that nominations to replace Mr. Hagman are on-going, but not publicly available to be discussed yet.
Mrs. Hurewitz said that Dr. Segev, in talking about donors, used the term “renege” for those who back out of donations. In the new regulations, the ACOT has endorsed informed consent and voluntary participation, including the right to withdraw at any time, up until the point of being anesthetized. This doesn’t square with the use of the word, “renege.” Dr. Segev concurred that this was a good point; his program allows donors to withdraw at any point. Some haven’t gone through because the recipient has backed out. They use that term because they want both donors to be able to withdraw until they are anesthetized. When the donations occur simultaneously, they can both withdraw.
Ms. Donna Luebke read the following statement to ACOT members: I am Donna Leubke, a kidney donor from 1994 and Nurse Practitioner with the Living Donor Advocate Program. If we believe that living organ donation has created a unique patient population with special needs, then we must put systems into place to care for our donors. In the United States, what happens to our donors remains “unknown,” since there is no living donor registry, although numerous meetings, published papers, and consensus conferences have repeatedly called for one.
Priority number one must be insurance reform. We are appealing to both CMS and to private insurers to reform their systems for reimbursement for the living donor organ. Please stop reimbursing as if we were deceased donors – expand coverage to include not only the 24-month mandatory data collection for donor follow-up pursuant to the Final Rule  and the OPTN’s contractual obligation, but also the cost of care for those donors who have ongoing medical needs due to complications or adverse events. Following recent communication with CMS, we contacted medical coding and billing specialists. They were surprised by “the lack of an organized system” for this process. It is not like this is something new or difficult to get together. Are donors given the recipient’s insurance information? They suggested that live donation follow a model similar to workers’ compensation where the donor would have a claim number to get care and have it paid under the recipient’s insurance. Alternatively, we could develop a rescue amount or umbrella coverage for donors. Tracking donors via the insurers would complement a registry.
To emphasize the need for both insurance reform and following living donors, I would like to introduce a living kidney donor. Her surgery (lapraroscopic donor nephrectomy) occurred December 5, 2003 at the age of 33. Unfortunately, she could not travel to this meeting, since she is disabled as the result of this surgery and the two subsequent surgeries she underwent to address complications. Following donor surgery, she was never scheduled for an appointment, not even a wound check. She was left with a 13-inch hernia, an amputated umbilical stem, nerve entrapment, adhesions, and excessive scar tissue. One of the nephrectomy incisions was from two inches above her umbilicus to three inches below it. She later discovered that they had never closed the peritoneum, thus the resulting and massive hernia. They initially said she would have a two-inch scar and smaller dots from the lap device. I will be her voice.
My name is Angela Johnson Scott. The donor surgery and the two that followed have left me unable to work or to care for my family. I worked for many years in the telecommunications industry and had a high-profile corporate account position. I gave presentations to Fortune 500 companies, and handled companies such as the US Army at Fort Gordon, and International Paper. I loved my work and never intended to “retire” following the donation. I was given false, misleading, and unsupported information by doctors and the transplant team.
I firmly believe in the cause of living donation, but how can the government support this cause with no support for the living donor? I would do it again, even knowing what I know… my uncle, the recipient, feels incredibly guilty for my circumstances. We had been told that I would be back to normal in less than six weeks. Four years later, I must wear two support garments so that I can walk. I am in pain from the moment I wake up until I go to sleep at night. I cannot lie flat, or stand up straight without a searing pain through the center of my abdomen. I cannot do laundry. I cannot shop for groceries. I seldom leave my house because driving is a nightmare. I spend most of my days in a fetal position with a heating pad on my stomach. My life will never be the same, and I am working on accepting that fact. I no longer enjoy doing the things I did before, and I am deeply depressed. Frequent panic attacks are something that I deal with. The guilt I feel is overwhelming; I have become such a burden to my family. I will never again be the person I once was, but I am tough and I will get on with what I can do. Maybe I can help someone else to not find themselves in my situation.
The insurance didn’t want to pay for any of the hernia surgery, but I pressed until they paid for all but $1,500. The second time around, I just didn’t have any fight left in me to pursue it and we had insurance, so I just used ours. We are recovering and making the necessary adjustments. I am just sickened by the lack of concern for donors. They spend millions to recruit us, and nothing to take care of us when things go wrong.
I read the ACOT minutes, and see that Mrs. Rhonda Boone asked a question, and was quickly dismissed and told to write a letter. I have written to the National Kidney Foundation, the President, the Vice President, the President’s Council on Bioethics, the Governor of Georgia, my local Congressmen, the Speaker of the House, HHS, HRSA, UNOS, the General Accounting Office, the House Ways & Means Committee, the Subcommittee on Social Security, and the Social Security Administration (since filing for SSDI in 2006), and the Living Donor Advocate Program. According to the most recent ACOT minutes, they still have not decided what to do about living donation. I just hope that this will change as we move forward. We deserve better care, and follow-up, and the truth about the surgery. That’s all I want for donors. Someone has to take responsibility.
Ms. Agrawal thanked Ms. Luebke for her statement. The meeting was adjourned for the day.
Further Discussion and Vote on Workgroup Recommendations Resulting from November 2006 Meeting
Ms. Agrawal started the meeting by talking about the public comment from yesterday. She commented that she spent a lot of time the night before thinking about it, and it raises a question that’s troubled her for some time. What can we do about the very terrible cases that are brought to our attention with respect to donors. They have come up repeatedly in the last 6 or 7 years.
Ms. Agrawal shared her thoughts in the hope that ACOT might find a direction in which to move. On May 15, ACOT members heard about some very tragic events with respect to living donation. This is not the first time these events have been heard; some members, particularly Mrs. Rhonda Boone, have lived with this for a long time. The Committee has also heard about the miracle of healthy donation – but that doesn’t change the reality of bad outcomes when they happen. What can ACOT do?
In terms of informed consent, ACOT members heard that someone was told the risk was minimal when the individual became a live donor. The law about disclosure has been around for 30 years and includes the need to describe material risks. Yet, if a physician says there is a slight risk of something terrible happening, it doesn’t make it any less terrible if it actually happens. The ACOT has recommended that a wide range of information be provided to those contemplating living donation. The law says “medical risk” must be discussed, but we recommended that this be expanded to also include psychosocial risk, insurability, and future employability. Dr. Frank Delmonico is in the room, and he will remember that ACOT tried to draft an informed consent form, which ended up being something like 20 pages long. At that time, ACOT members recommended that the informed consent form needs to be just that long and detailed. CMS has not used our full list, but the agency is looking more seriously at informed consent. The ACOT also has recommended that all living donors have an independent advocate, and CMS picked up on this, too.
In terms of public solicitation, many of the fears surrounding this issue come from a concern that people will enter into becoming a living donor lightly and without understanding everything they are getting into. Legal counsel has looked at regulating public solicitation, but the legal conclusion is that this can’t be done because of the First Amendment. We have asked the Secretary to urge UNOS to adopt practices on public solicitation although the Department can’t regulate this. Further, we lack long-term follow up on living donors. We deal with a lot of uncertainty in medicine, but donors should be made more aware of this lack of long-term data. The ACOT could also recommend that there be a bank of information to capture long-term donation outcomes.
What else can ACOT do? Ms. Agrawal commented that the lawyer in her hoped that woman whose story we heard yesterday called a lawyer – that is a tort! Medically, if something goes awry – as in Mrs. Boone’s situation or the story from yesterday – the lawyer in her says there should be a malpractice case. Are the bad things that occur inherent risks of the procedure or was it malpractice? The ACOT has made recommendations about this, such as imposing and enforcing performance standards. CMS monitors the Centers, and SRTR collects data so we can see who is operating below par. There are also many legal structures that regulate quality, such as licensure, certification, accreditation, malpractice laws. Ms. Agrawal is not sure what else ACOT can recommend around that issue. If there is something that can be recommended which will help prevent tragedies or ensure highest quality, the Committee should do so.
On the subject of informed consent, those who are thinking about becoming a living donor are fully educated about their risks and, therefore, can decide. But, is there something that ACOT has not done that we should or could do? Ms. Robinson commented that her father was her donor; and if anything had happened to him, she would have been devastated. When he went through the donation, there was a great deal of paperwork, consent, and follow-up. She is not sure how consistently this occurs, however. Education could come from somewhere like UNOS or the Kidney Foundation on what a live donor should look for. That would be helpful as a tool for someone considering donation. Twenty years ago, they only accepted donations from living relatives; it gets fuzzier as you go further out from immediate family members.
Dr. Scantlebury noted that informed consent for a living donor is different from informed consent for a general operation, for something that will benefit the individuals themselves. Surgeons probably assume people understand more than they do and might be caught up on the donation rather than focusing on the risks. The more donations that are done, the more complacent we may become in assuming informed consent. We should ensure that the person repeats the information back, so we know they understand. Could there be a portion on the UNOS Web site – which all Centers have access to – where the coordinator can log-in for a potential donor and have them answer questions; and answer specific things like, were you told about this? In this way, we could document that they have logged on, received the information, and agreed that they have received it. This is a system that people already use, to make sure that people really understand the consent they are giving.
Ms. Agrawal said she has gotten information from OPTN/UNOS about living kidney donor evaluation guidelines; she will ask the staff to make sure this information is shared with ACOT members so they know what is out there. Mr. Aronoff will report on this, as well, but it will also be useful for members to see what the ACOT has done around informed consent. We may need a workgroup on this for the next meeting. Members should be informed about what is out there and what we have done, so we do not reinvent the wheel.
Dr. Migliori commented that this is not a new problem, nor one that is isolated in the living donation field. It’s a part of American medicine. In women considering breast cancer options, for example, we learned that, no matter what you put into an informed consent form, all we can tell is that the patient signed it. We have no confidence that the content was understood. The industry has created a “shared decision model,” which is interactive. Not everyone reads well, or learns from reading. Information must be fair, and conveyed in a way that works for the person. You can only tell that they have gotten and retained the information by testing people – by questioning them about what they have learned. Or you can have absolutely no confidence they have learned anything. Based on the compelling stories heard by the members, Dr. Migliori doesn’t think this is an unreasonable thing to do. The Committee should not shy away from subjecting people, who are making the decision to be a living donor, to provide proof they know what will happen and that that they can withdraw at any time. It gives them knowledge and it empowers them. Then, the surgeon can have confidence that the information was conveyed to the donor. Ms. Agrawal agreed that, for lawyers, informed consent has never been anything but evidence that the required conversation was held with the other person. It is not supposed to constitute proof that that they learned something.
Dr. Lorber said that there are a lot of effective training vehicles that either are – or could be made to be -- interactive and effective, so that people who are contemplating this will be forced to actually think about the realities. Most surgeons, when they have these conversations, try to impart the information that they know, but it may not be effective. We ask them to come back and talk about it more, and it still seems like people are not thinking about possible negative outcomes. It’s hard to get people to think about really negative consequences until they have happened. We could really get at this vexing question once and for all.
Dr. Leffell suggested that it might be possible for ACOT to set up a review board through OPTN to review adverse events. In terms of making data available to patients, we have talked about a long-term registry for follow-up with these patients for a long time. It’s important to do this and to make it available to patients – for example, African Americans who are risk for developing hypertension. Because it might jeopardize their remaining organs, they need to know this sort of thing.
Dr. Solomon said that there are some things that can be done around tracking quality not just at the Center level, but also at the surgeon level. This is controversial, but it would be a response to the problem. She made three suggestions. 1) Dr. Hanto talked about follow-up difficulties and it being hard to get donors to come back, as well as expensive for donors to do so. Cost cannot be a reason that we fail to collect the data – everyone makes money in this system except the donor. Cost should not be tolerated as a reason. 2) To motivate donors to come back, a system that is convenient for the donor can be created. The donor’s physician can provide annual data to the system, for example. 3) Because the donor does not make money, a financial pool that supports catastrophic costs should be created. When really bad things happen, we have a social commitment to these people who have taken the risks. Dr. Solomon also underscored the use of interactive tools. She is developing such a tool for the National Children’s Study (a longitudinal study with 100,000 women). The NIH wanted an impeccable informed consent process, so they are using video to model the program and the risks, with an embedded assessment process. They can tell how many times it took the person to get the answer right, and then the video shows the person information that is tailored to their responses. To have only informed consent is inadequate. Someone has to be responsible, if something bad happens, even if the donor has been told about the risks.
Ms. Principe asked if the donor advocacy program, which is to be in place in all Centers nationally, could be further developed so that there are people who are witnesses to the consent process. This would be independent. On the live donor side, we have had the attitude that you are healthy and doing a wonderful thing; this has moved to a place we never thought we’d get to, with solicitation and science.
Ms. Agrawal suggested that ACOT proceed by having Mr. Aronoff form a workgroup on this. She asked members to communicate with Mr. Aronoff if they are interested in being on it. The workgroup will become informed about what already exists and what ACOT has already recommended. Dr. Lorber added just because it’s been recommended in the past, if no action has been taken, should not prevent ACOT from reminding the Secretary about the previous recommendation. Ms. Agrawal agreed that the ACOT can reiterate, revise, refine, etc. The workgroup will bring back the nature of its deliberations along with recommendations. She commented that an early ACOT subcommittee worked on this issue for a year, but it’s a good time to reexamine the issue. Mr. Aronoff commented that all of the past ACOT recommendations and actions relating to them were in the meeting packets.
Ms. Agrawal reminded the group about the previous day’s recommendations on tissue banks. She informed the members that a statement from the Association of American Tissue Banks and the Eye Bank Association of American had been distributed to them. She recommended taking the issue back to the Tissue Workgroup to decide how to proceed. She welcomed members’ comments on this issue.
Mr. Holzman commented that he had read the statement and welcomed their input to the Committee and their help in members’ understanding of the issues involved. He does not agree with the contention that this is an area in which ACOT should not be involved, however. Donation is donation, and there is a huge crossover effect between tissues and organs when something bad happens in either field. It’s legitimate for ACOT to take this question up. It will be helpful to define the concerns that people have so the Committee can have more direction in doing so, however.
Ms. Rosensweig said that she would have liked for the group to come to consensus. After reading the statement, she would like clarification from legal sources on the parameters of ACOT’s jurisdiction so we all have an understanding of whether we have firm footing here. What issues do not interrelate – they seem to all be blurred together.
Ms. Levine clarified that the ACOT’s charge is open-ended but is related to organ transplantation. The Committee’s consensus is that the tissue donation has a direct effect on organ donation. ACOT members need to keep coming back to the effect on organ donation and transplantation. Fact-finding beyond that question is legitimate, but ACOT recommendations should focus on organs. Members are the “experts” so the Division of Transplantation will likely defer to members’ judgment about why this has an impact. Mr. Frieson asked the eye and tissue bank representatives to speak to their concerns.
Mr. Bob Rigby, CEO of the American Association of Tissue Banks, spoke and noted that there are five issues at play. First, is jurisdiction. The issue was framed on the previous day of the interrelationship between tissue and organs. It goes both ways, though, and the tissue banks have negative outcomes and receive criticism when bad things happen involving organs. Second, he feared that a precedent is being set. Nothing in the ACOT charter is about tissues; it’s an indirect jurisdiction. This is setting a precedent, with consequences for organs and ACOT, too. The FDA advisory committee may want to look at organs, for example. Third, he questions whether there is a need for this. The fact of the matter is that organ donation is at record high levels, as is tissue donation. It does not seem that the rates are being negatively impacted, in fact. Fourth, this area is outside the members’ knowledge base, as organs are outside his. Members have said that the FDA has no quality regulations on tissues; but it does, in fact. ACOT members do not seem to know about regulations on importation and exportation, which FDA currently regulates. Registration has been on the books for 5 years, and inspections have been happening since 1993. It is already law. Fifth, and finally, he was unsure how to interpret the second recommendation from the previous day. Is it that anyone dealing in organs should be accredited by the organizations? The two associations would support and agree with that, as it will help ensure the safety of the U.S. tissue supply.
Ms. Patrica Aiken, President of the Eye Bank Association of America, spoke in agreement with Mr. Rigby. She cautioned that, if ACOT does expand its jurisdiction outside organs, it should add experts to the Committee before doing so. Ms. Aiken noted that she had lost a sister to kidney disease and, as a sister, would have given anything regardless of informed consent processes, to save her sister.
Dr. St. Martin from the FDA reiterated that the FDA has jurisdiction here and is evaluating the new regulations’ implementation. FDA is engaged in an extensive and complex process. FDA made a presentation at the last ACOT meeting and would be happy to meet further with ACOT members and answer questions. The FDA has a Blood Safety Advisory Committee that has tissues and organs added to it, as well.
Transplant Tourism – Dr. Francis Delmonico
Dr. Delmonico began his talk by noting that he has had a happy association with ACOT in its early days; he commended the members for their activities. He was honored to share with members what is an emerging problem for the U.S. and international nations. This will impact the patients. He cautioned that there are a lot of gaps in the information, as there’s no UNOS database on transplant tourism. He has been to Slovenia, Buenos Aries, Karachi, Trinidad and many other places as part of his work for the World Health Organization (WHO) on the practice of transplant tourism.
WHO is concerned about this because “A shortage of organs, together with the high cost of health care in developed countries, has led to the growth of ‘transplant tourism,’ in which centres in some developing countries use the internet and other means to solicit patients to travel abroad to receive a transplant at a ‘bargain’ price, ‘all donor costs included.’ Likewise, commercial traffic in organs – and even traffic in organ donors who leave their home countries in search of financial rewards for donating their kidneys – continues to be a serious problem, particularly in countries whose transplant programmes cater to foreign recipients. The occurrence of unethical practices (such as organ trafficking and transplant tourism) which take advantage of poor and vulnerable populations makes clear that better regulation is crucial if live donors are to be adequately protected from exploitation and physical harm.”
This is not specific to other countries because Americans are going outside of the country to get organs. Recipients can go to another country and get an organ and seek care back at their home country. Many Americans who come back from this are really messed up. The donor also can travel to the recipient’s home country to donate the organ; alternatively, both can go to a third country for the transplant. For example, Israelis go to Moldova and meet their donor. This kind of process has been shut down in South Africa but continues in other countries.
The WHO has collected what it can learn about “host” countries and “client” countries. Host countries seem to be developing (Pakistan, Egypt, Philippines, Columbia); “client” countries are rich (Saudi Arabia, Taiwan, South Korea). Organs that are made available in China are from executed prisoners – about 11,000 of these organs have been made available in China annually. The WHO is trying to stop this practice, and held a meeting in China recently about it. There are literally hundreds of transplant centers in China. The Vice Minister recently said there will be a challenge to this practice in China, stemming from the work of the Falun Gong. Members of Falun Gong display posters at every single meeting that occurs around the world, and the Chinese know that this is generating really bad publicity. The Olympics are coming up and the Chinese government does not want CNN to film these posters. There is another piece, however, in that the government really does want to make change.
The Vice Minister recently sent a letter to the transplantation society saying that China will develop a national law like the National Organ Transplant Act. They plan to ban the purchase and sales of organs, prevent trafficking, and create a plan for national self-sufficiency (use China’s organs for its own patients). What is the judicial process? When there are 4,000-5,000 people executed annually as a source of organs, it’s clear that the need for organs fuels the need for executions. When a person goes to China and gets an organ, someone has been programmed to be executed to make that organ donation happen. The Chinese, however, seem to be keeping their word and, on May 1, released their new regulations.
So, if China shuts down and no longer provides 11,000 organ donors; what happens? The WHO is working with the Egyptian Ministry of Health to help cancel the organ sales in that country. Relationships matter in getting something done about this; and the WHO matters.
Dr. Delmonico showed a slide about IndUS Health, which is outsourcing transplantation. People are going to India for organs. As far as U.S. patients going abroad, HRSA data indicate that increasing numbers are going abroad. There are hundreds that we know about to date. The donors are being exploited for their organs. For example, in India, people who have been displaced by tsunamis are approached to sell their kidneys.
Dr. Delmonico provided Web sites soliciting recipients to come to Columbia or the Phillipines from Israel. What we see is that, when transplant tourism shuts down in one place, it emerges in another. Pakistan is an emerging market, for example.
What are the consequences? There are some data available which indicate there are no long-term economic benefits for the donor. They become destitute, depressed, and sick, and now they only have one kidney. Their health has declined, and they have sold their organ for a very small amount of money.
Dr. Delmonico introduced Dr. Debra Budiani, who presented information on practices. Dr. Budiani is a medical anthropologist and director of the Coalition for Organ-Failure Solutions (COFS), an international non-profit organization based in the U.S. COFS is a non-profit international health and human rights organization committed to seeking ethical solutions for organ-failure patients and combating exploitation of the poor and vulnerable as a source of organ and tissue supplies. The Coalition primarily works in the Middle East and calls for state accountability for establishing solutions to organ trafficking; supports movements to secure solutions for patients in need of organs and tissues; provides outreach services to individuals who have been solicited as a commercial living donor; and provides outreach for prevention to vulnerable groups of potential donors.
According to the United Nations Trafficking Protocol to Prevent, Suppress and Punish Trafficking in Humans, “organ trafficking occurs where a third party recruits, transports, transfers, harbors or receives a person, using threats (or use) of force, coercion, abduction, fraud, deception, or abuse of authority or a position of vulnerability for the purpose of removing that person’s organ(s).” Dr. Delmonico demonstrated that transplant trafficking usually involves crossing boarders, but is defined wherever a third-party engages in the above activity. It can happen within countries as well as across countries. When it occurs, what happens is that the prices drop rapidly.
In Egypt, when organ trafficking started, a kidney cost $2,700. That price has dropped to $1,700. Ninety (90) percent of donors are estimated to be unrelated and commercially donated. A third of the transplants are estimated to be unlicensed. What happens is that the laboratories are the brokers; the recipients and the donors meet and negotiate a price. The method is the same in Iran. The laboratories are the transplant sites/vendors. Iran is supposed to be regulated, but it’s really not. The contention that only an Iranian can get a transplant in Iran is untrue.
Dr. Budiani’s study focus group provided the first opportunity for donors to meet other people who had been donors as well. There were 50 Egyptian donors who participated in the qualitative aspects of the study. Almost all (94%) were unrelated, commercial donations. Most of them are homeless or very low income and in debt or other financial crisis. They were recruited by brokers or solicited in some way to be donors. Most (78%) reported that their health had deteriorated after the donation; most (73%) reported a weakened ability to perform labor-intensive work. Over 80 percent had spent the money they earned within five months of being paid (81%). They learned a lot about donor concerns about not going to heaven if their organs fail because they have committed a sin in donating their organs. The majority (94%) felt regret over their donation; 91 percent felt socially isolated as a result of their donation; and 85 percent were unwilling to be identified as having sold their organs.
Her conclusions are that the current circumstances of transplants in Egypt are market driven and discourage altruistic and/or deceased donation. Her research indicates that commercial living donors do not receive follow-up care and reported suffering significant consequences as a result of their donation. These findings are consistent with studies also conducted in India, Iran, and Philippines.
Adequate longitudinal data on commercial living donors is lacking, particularly in the developing world. They face unstandardized donor assessment criteria. Commercial living donors in the developing world are already “at risk” populations by virtues of their poverty and the same epidemiological threats that have caused organ failure of their recipients. In fact, regardless of whether these donors are sick or well, all who resort to an organ sale in the developing world are “at risk.”
Returning to Dr. Delmonico’s presentation, he noted that UNOS has been asked to provide a data registry. He and Dr. Budiani are traveling to Egypt to develop a field survey about what is occurring and trying to work with the ministers to establish relationships. Novartis and Roche have been engaged in creating the registry.
The Amsterdam Forum was created to address the needs of the live donor. This work needs to be done both internationally and in the United States. The Swiss and the Swedes have registries of their living kidney donors. The U.S. also should have a registry of those who give their organs. Dr. Delmonico expressed the hope that the ACOT will continue to promote this effort. Although the NIH is doing retrospective work on this and UNOS has adverse event reporting, there is much more to be done.
Data on outcomes are starting to emerge. A report from Canada on individuals who traveled outside the country to receive organs found that their outcomes are not as good as those who received their transplant in Canada. Specifically, their kidney function is not as good. What is the impact on Medicare if someone goes to Pakistan or China and comes home to be treated in California for care? It doesn’t appear that patient is going to be able to get Part B coverage, if he or she did not have the transplant in the U.S. However, the recipient could get immunosuppressant drugs under Part D. ACOT could address sort of situation.
The idea of regulated markets and promoting organ sales is a concern because just knowing that the U.S. is considering a market consoles places that already have such a market. These places know the possibility is being discussed and it encourages them. Even though it is not going to happen in the U.S., for the reasons raised by the Institute of Medicine report (Organ Donation: Opportunities in Action), Congress is concerned that there not be markets.
A free market in organs is problematic. Every society draws lines separating things treated as commodities from things that should not be treated as things that are “for sale." Despite the growing market for body parts and products, there remains a strong societal taboo not only against buying solid organs from living people but also against buying and selling dead bodies or certain parts of dead bodies, including solid organs. Organ donation currently enjoys strong support from most major religious groups. However, a policy of paying for organs may weaken or eliminate the commitment of religious groups in encouraging their members to donate. The Committee believes that there are powerful reasons to preserve the idea that organs are donated rather than sold.
Ethical considerations for living donations include the following ideas. 1) Compensating living donors opens up the possibility of exploiting poor and underprivileged people and also increases the risk that potential donors will withhold relevant medical information. 2) The Committee’s reasons for rejecting a market in organs from deceased individuals apply with even greater force to a market involving organs from living people. 3) These reasons hold even though a few analysts argue that it would be cost effective to pay individuals as much as $90,000 to provide a kidney for transplantation and even propose changes in the laws to permit such a payment in a regulated market. These proposals have yet to gain traction in the United States because they are incompatible with the fundamental values and norms that govern transplantation and because international markets in organs from living individuals appear to involve the exploitation of relatively impoverished people.
The ACOT had asked UNOS to gather data about markets. In looking at kidney candidates on the list from 2003-2005, the percentages of those who are “inactive” increased. “Inactive” means that a person is on the list but is not going to get an offer because of the inactive status. It turns out that 25 percent of the list is inactive (approximately 17,000 people). Who is dying on the list, and are they active or inactive when they die? Fifty percent of those who die on the list are inactive and would not get an offer. They are older, so the question is, were they all right when they went on the list? We don’t’ have conclusive data on this, but we do know that about 40 percent of inactive list deaths are in people who have been inactive for at least one year on the list. Conclusion is that the market will not solve the problem of people who are dying on the list. The most common reason people lose their kidney is because they die with a functioning graph. Is it another measure for who is suitable for receiving an organ?
The Saudis are aware that China is changing its practices. If there are different prices available on the market, it will lead to shopping for the cheapest price. If insurance companies are behind this, it will be a problem and we should comment on this to them. This possibility may emerge, and we have to watch for it and recognize that if you send a vendor from Manila to Riyadh, it’s because the price is best. In England, a man has just been jailed for selling his kidney.
This is a huge issue for the world. The U.S. needs to stand forward on this and make recommendations about it. The NIH is helping to create a system for people who want to be live donors. The ACOT also should think about what can be done for the donors, respecting their dignity. The line in the sand is, of course, cash payment, but there are other benefits that we can offer to donors, in terms of reimbursement of their expenses, repayment for their lost labor, assistance for their physical/psychological health, and life insurance. What we can do for donors is an issue that has not been addressed fully enough in the U.S. We need more data about what happens to the Americans who go abroad for organs, and what happens to the people who give their organs internationally. The U.S. should be calling for greater awareness about these issues.
Dr. Wiesner agreed that this is a huge problem and asked about American-licensed surgeons who participate in transplants in other countries. There are active surgeons in the U.S. who travel abroad and come back home. He asked if the U.S. contributed to the problem in this way. Dr. Delmonico responded that the U.S. trains doctors, who go back to China; but there are few data, just anecdotes.
Dr. Wiesner asked about the waiting list patients who are inactive. Is it known why they are inactive, or why they died? Dr. Delmonico responded that these data are not being collected because people do not want to do it. Dr. Port agreed that there is a need for more data. At the recent American Transplant Congress, the SRTR presented a paper on patients who were taken off the transplant list. The field might indicate the patients were transplanted in Manila or China. There were over 100 patients with that sort of record, but the SRTR does not know what happens to them later. He thought it would be good to collect data through UNOS, so they can be followed. Dr. Delmonico noted that the ACOT could recommend that, if a transplant center knows of a patient who has been out of the country, it could become a reportable item.
Dr. Migliori asked how Americans have done this and what the best way is to track it. Dr. Port said that, if a patient goes back into care at a transplant center, which is commonly how they are treated, then there should be a reporting system for this. Some of the patients do not come back, of course, because they die. The ones who are under the care of a U.S. doctor could be reported to UNOS, and SRTR can track them. CMS can track the claims data post-transplant, if the recipients go back on dialysis or have complications. Dr. Migliori suggested that the ACOT could make a recommendation for mandatory reporting in this sort of situation.
Dr. Zhu commended Dr. Delmonico for working on this issue and for creating standards. It will not happen without the U.S. doctors’ involvement. He confirmed that he knows U.S.-trained surgeons who travel to Chinese hospitals that cater to foreigners in China because of the cheap lab technicians and other costs. Well-known senior physicians take vacations there and perform operations, including transplantations. He doesn’t think this is not necessarily bad because the clinical state of art and technology is being shared. However, it does need to be regulated. Personally, he believes that the main source of organs was from executed prisoners because there are no legal rights for prisoners and no other system for donation. He does not believe this practice is widespread or is supported by the state any more. The exhibit, Bodies, for example, is probably composed of prisoners’ corpses. This happens because families do not pick up the body of the executed prisoner, because of the shame, so that’s one source. The substantiations should be affirmed, however. The assertion that the state is involved may damage your personal relationships, which are very important. Dr. Delmonico said that the state will not be supporting these donations in the future; but if you can predict a transplant happening within two weeks of your arrival in China, it is not possible to draw a conclusion other than that the organ source was pre-established prisoner. We are very much commending the Chinese government for changing.
Dr. Solomon recommended that the ACOT establish a workgroup to study the inactive persons on the list. It’s courageous to point out that a lengthy waiting list can be used as a communications tool for encouraging donation. Also, the role of physicians as opinion leaders in these countries is important. We know that the physicians have a high status and have influence (for both good or for bad). Dr. Delmonico is focusing on the morality of organ sales, but we can also focus on the role of medicine and our ethnical obligations. We could present at places like the International Bioethicists’ Society conference on the need for peer pressure. Dr. Delmonico agreed and noted that he is going to Israel to work with physicians there who do not want organ transplantation to continue to be outsourced to other counties.
Dr. Vega asked if ACOT can query CMS for data on those who receive immuno-suppressant medications but for whom there has been no payment for transplantation. Dr. Migliori commented that it depends also on who the payer was when the transplant occurred.
End of Life Care and Controlled DCD Recovery – Dr. Mildred Solomon
Donation after Cardiac Death (DCD) has been endorsed by the Institute of Medicine and the Breakthrough Collaborative has, as a goal, to increase DCD. Policy support for DCD has yielded growth and interest in this area. There is much variation among the organ procurement organizations (OPOs) in terms of practice, however, and a small number account for most of the DCDs performed. Nonetheless, growth in DCD is expected to increase rapidly, not least because the OPTN Board Bylaws now require OPOs to develop protocols on DCD, and Joint Commission is requiring hospitals to develop DCD policies as well. Joint Commission does not say what the policy should be, however. Hospitals can say they object to it and that they would transfer patients whose families want DCD.
There is a lot of policy support for DCD, yet all three IOM reports describe the ethical challenges that exist with respect to DCD. These issues include alignment with the Dead Donor Rule (irreversibility/permanence of cardiac cessation); the use of pre-mortem interventions; and the impact on end-of-life care. Of these three, the last is the most important. The other two can be more easily addressed.
Death is not random any more in many cases. The possible ethical concerns are the impact on palliative care. Organs from cardiac/respiratory cases suffer ischemic damage that can damage the organs. In DCD, the ventilator is being removed, but the organs may be damaged and need to be retrieved rapidly. Second, the family should be present for leave-taking—in DCD, the need to recover quickly (see above) could impede the family’s ability to say goodbye. Thirdly, there is a concern about the patient having adequate analgesia.
Several OPOs are experimenting with how to address these concerns. At Beth Israel Deaconess, they extubate in the ICU, which is less disruptive for family, and then they use the time to transport the patient to the operating room as the start of the 5-minute clock. At Massey Cancer Center, they focus less on family leave-taking and more on providing support for the patient and his or her family. Any time there is a DCD situation, moreover, a palliative care consultation is required. These are good models, but we are not yet in the clear with the ethics involved. DCD decisions may actually enhance end-of-life care, as we know that palliative care consults do not occur often enough and we do not talk enough with families about the goals of care. DCD may encourage both to happen.
The most important ethical concern is the potential conflict of interest between the patient/donor and the recipient(s). Further care is deemed something the patient would not want, but the families or the doctors may be unduly influenced by the very real benefit of the donation. This raises two other ethical criteria that must be met: the prognosis of hopelessness must be accurate, and the prospect of organ donation must not influence withdrawal of life support. We need to ensure a firewall between decisions around life support and donation. This firewall cannot be broached until after the decision to remove care has been made.
However, is such a firewall possible? Determining hopelessness is vague and not clinically straightforward. It is more complicated than brain death. Now, clinicians may be obligated to raise the issue with families. In theory, the clinicians should not approach the family members until the decision has been made to withdraw life support, but is that the reality? We assume a linear chronology for the process, but that’s not how human decision-making occurs. Families will know about organ donation and they will factor it into their decisions. Many clinicians are concerned about this because they feel that they cannot separate the utility of the organs for others’ benefit, from their patients’ well-being. In fact, a study by Mandell et al (2006) on providers and DCD found that nearly everyone recognizes that it’s a benefit; but they are worried nonetheless. Some things that people are worried about can be solved with education; but not everything can be because their concerns are not all about a lack of information. People have very real concerns about motivations and whether the firewall will hold.
If clinicians can manage the issue, there remains an important medical challenge, which is the science of neurologic assessment. We need to know more about irreversible neurologic difficulties and what might improve them. The IOM has held a special meeting about problems of determining consciousness. Dr. Joseph Fins and Dr. Katherine Foley followed up on this meeting with a paper that noted the very scant knowledge that is being used to determine various states, such as “persistent vegetative.” Dr. Solomon noted that she is not saying that the science is bad and we should go backwards. Accuracy of prognosis (e.g., of hopelessness) will never be 100 percent and we have to be prepared to make decisions. As we proceed with DCD, however, there may be complications as the science evolves.
Dr. Solomon made several policy recommendations. First, CMS conditions of participation that require “timely referral” to an OPO should be interpreted differently for DCD than for cases of brain death. Critical care providers have many more days to contact an OPO in instances of brain death. The suggestion is that the providers only contact the OPO when the decision has already been made. Second, first person consent laws are very relevant for brain dead donors; but should not be invoked for DCD. The IOM says it is appropriate to solicit families, since the family is deciding about withdrawing treatment. However, the recommendation is that withdrawal and donation should not be considered to be the same time. Third, the UAGA states that providers must check the donor status before removing a patient from life support; but it is not clear if a donor card trumps an advanced directive. Finally, in the pediatric context, there are a lot of concerns being raised by children’s hospitals, which notes that children have greater recuperative powers than adults do.
In summary, DCD policies are good; but they come with obligations, which are specific to various communities. Critical care teams must hold routine conversations about the goals of care; interpret “timely referral” appropriately; prepare family members so they do not expect immediate withdrawal, leaving time for the OPO to approach; decide whether your presence with OPO requesters will enhance or diminish potential conflicts of interest; ensure optimal pain management for patients; and ensure optimal family leave, i.e., talking and bereavement support. Responsibilities for OPOs include the suspension of first person consent laws in DCD cases; and scrupulousness in remaining uninvolved until after the family has made the decision. Responsibilities for organ transplantation community and policymakers are to clarify the implications of the UAGA language.
Data are needed to proceed on the basis of evidence-based practice. Dr. Solomon’s concern is that we are proceeding with DCD across the country without knowing if the firewall is being, and if it can be, maintained. The IOM is likely to agree. We need research on quality of care, the conflicts of interest, firewalls, chart reviews, clinical case reviews, and clinician interviews. Also, we need to be sure that families are compared based on who did and who did not donate. The ACOT can help to ensure that policies go forward in the best way possible.
Ms. Conrad described the situation in which her facility offers DCD. It is typically individuals who have been hanging on for several days in the ICU. They offer DCD as a form of hope for the families, which they really appreciate. In terms of the timing of the referral, calls are received right up to when the nurse is removing the tube, and there is not time to offer the option to the family of making a donation in those cases. Hospitals are encouraged to call them early. They are very much in the background, where they can make an assessment. Doing so enables them to tell if an even better offer can be made. The consent form for the family is different for DCD. In terms of whether the donor card trumps the advanced directive, the State of Iowa passed the UAGA and added that it’s recommended there be a conference between the family and those attending, to determine what the person would have wanted. For pediatrics, it is difficult. It’s hard to tell when the point of neurological no-return has been reached. They typically rely on the pediatric ICU exclusively for this.
Dr. Solomon commented that she agreed with everything Ms. Conrad had said, except the portion about hoping to be called early. That is problematic. Also, in terms of the relationship with an advanced directive, she was asking about situations in which one doesn’t know if the donor is registered, but the OPO is trying to find out. Do you have to intubate the person while you are looking to see if they have an advanced directive saying not to do this?
Ms. Agrawal said that her understanding is that this only applies in situations in which we know there are two forms. The UAGA was not intending to speak to appropriate clinical care and intubation. It was only for narrow circumstances where there is a donor card, and they are trying to see what they should be doing. It’s hard to capture all of this on the back of a driver’s license—it would be good if we could add: “Do whatever you need to do to preserve my organs for donation.” The presumption is that the donor card trumps, to the minimal extent necessary, in order to facilitate donation. You are not obligated to intubate when you are checking that out. Ms. Conrad added that her facility has had one call in 20 years about this situation. Dr. Solomon clarified that many people are really confused about the new language.
Dr. Low noted that the first thing his facility does, after deciding to withdraw or withhold care, is to call the OPO. It becomes blinded to him– someone else calls and he is just notified that a donation may be occurring. That helps with the firewall. In terms of intubations, you have to provide care that is right for the patient. This is not a case of doing something that would not ordinarily be done for the patient.
Dr. Lorber concurred with Ms. Conrad’s comments. In terms of when to call the OPO, his experience has been that the OPO is incredibly responsible and responsive. He does not want to back off on early calls. They enable maximizing the chances that the situation will go as optimally as possible. Waiting sets up the potential for rushing later and not proceeding carefully. Dr. Solomon asked if Ms. Conrad’s facility both encourages early referral and approaches the family. Ms. Conrad clarified that they look at the chart and let the medical professionals know if the person is even a candidate. This way, the medical professionals cannot offer the hope of donating if the person isn’t appropriate.
Dr. Solomon cautioned that it is precisely this action that many people feel is very offensive, and exactly what they feel we should not be doing. The protocol could be that the OPO is only called when the conversation has occurred with the medical professionals and the family. Ms. Conrad responded that, in reality, when a family has made the decision to terminate care, they do not want to wait. They want to move ahead. If there is no hope of DCD, then that is what happens. We are not in the way, but one cannot say if a person is even a candidate for DCD until he or she has been evaluated. Dr. Low added that withdrawal actually does not need to occur in 5 minutes. It is possible to take time, 30-60 minutes, to do things right.
Mr. Frieson concurred with Ms. Conrad too. There is a standard among OPOs. For early referral, especially for DCD, the OPO gets a call saying that a family wants to withdraw support. The OPO staff goes to the hospital and talks to the medical director and reviews the person’s chart to decide if the person is even a candidate for DCD. If he or she is a candidate, only when the family says they want to withdraw care do we intervene. There are variations among OPOs in how they proceed with a donor card; some say they will just go ahead, others do not. Beth Israel Deaconess does a great job. They even do drills to see how long it takes them to remove someone from support and get them to the OR. Over time, we will fix the things that do not work optimally. Public and professionals alike are still learning how to deal with it; education and time will help with this. Seeing one, doing one, it all becomes clearer.
Ms. Newton added her voice to Ms. Conrad’s. OPOs are required to have agreements with hospitals for organ procurement and that agreement should speak to how DCD occurs. OPO regulations state that, if they do DCD, it must be covered in the hospital agreements. Early referral has always been the gold standard. Problems with perceptions about the OPO among clinicians can be solved with education – it’s the old misperception that the OPO is a vulture. There should be no blanket recommendation that the OPO not be called early.
Dr. Solomon concluded by noting the field needs to take the message seriously. It may not be that people don’t understand the issue, but that they do get it and are still not be happy about the ethics involved. She hopes that people can remain engaged in a productive way, as ACOT members have just done.
Insurance Discussion --
The group discussed ACOT’s recommendation #44:
The ACOT recommends to the Secretary that he promote collaboration between the transplant community and the industry to adopt standards of coverage for living organ donation specifically relating to future adverse events resulting from the donation.
Dr. Migliori commented that he has the good fortune to work with the American Health Insurance Providers (AHIP). AHIP has relationships with 200 million Americans, and they are very interested in the issue of protections for living donors. AHIP brought together senior medical staff from all of their affiliated insurance companies and is working with the Secretary and ACOT on these issues. AHIP conducted surveys to confirm what is going on with insurability of donors and it looks as though the care and transplant are covered. Care after transplantation and the time period of the coverage itself are varied.
When AHIP realized this, they were very sympathetic. They are interested in standards for the industry; and they realize that it’s important and ethical, although expensive. AHIP is compelled by the plight of the donor. The ideal in the previous public testimony about coding and adopting coding process for the donor to help track donor-related issues can be brought to the joint effort. There are ICD-9 codes for being a donor, but not for transplant-related complications. Right now, something can be coded for hernia repair, but there is nothing to indicate that the procedure was related to organ donation. It is Dr. Migliori’s suggestion that there be a coding system for the donor.
Ms. Principe asked about the situation in which donors are obliged to get a letter of denial from their own carriers, so that the recipient’s insurer will pay. She asked if this has this been discussed by AHIP. Dr. Migliori said that AHIP was going to discuss this. Four out of eight companies did have policies requiring this to occur.
State Donor Registries – Dr. Mary Ganikos and Mr. David Marshman
Dr. Ganikos discussed registries and Division of Transplantation. A registry is a way of noting that you want to be a donor. Registries are what you hear most about today and people are very committed to it. The UAGA has defined a registry as a database that contains records of anatomical gifts and amendments to or revocations of anatomical gifts. As a system for designating one’s wish to be an organ, tissue, and/or eye donor, a registry has three main functions which distinguish it from other methods: designation, storage and access. Not all States have a registry, however. There are 45 States with registries, and 7 without; New Hampshire’s registry is in development.
Storage and access models include registries that are housed and accessed by the State Department of Motor Vehicles (DMV); housed and accessed by a procurement agency; hybrids that are housed by DMV but accessed by a procurement agency; and registries that involve a “third party” organization. The minimal requirement is that a registry must be available 24/7, must be secure, and must be accessible to all procurement organizations.
Dr. Ganikos also noted that registries have to be easy to get into, and easy to get out of if a donor changes his or her mind. There should be multiple enrollment venues such as through the DMV. They should also have the capacity to aggregate data available to procurement organizations and researchers for monitoring impact of interventions in the community, look by ZIP code at effect, and assess where to target efforts. Registries also should have opt-in capacities, with consent only. We need to know if a person wants to be a donor and his or her entrance in a registry gives the organization the legal right to go ahead. Knowing what the person wants to happen really helps the families decide what to do. Knowing that the person wanted to be a donor increases the likelihood that a family will donate (from 70 percent to 90 percent).
Why are registries superior? With all other ways of indicating intent to be a donor, potential problems might prevent the donation from happening. Registries have 100 percent reliability and provide indisputable evidence that the person wanted to be a donor.
The history of registry evolution in the U.S. is that in the early 1990’s, the Division of Transplantation met with American Association of Motor Vehicle Administrators about it. A study found that a State-by-State system is more cost-effective than having a national system. Illinois was the first State to do a registry of intent in 1992 and Pennsylvania created a consent registry in 1995. In 2001, Secretary Thompson wanted to promote donation, including the concept of registries. A national conference was held in November 2001, which generated a consensus about not creating a national registry and gathered concerns about protection of confidentiality. Conference attendees noted a preference for State by State with interstate access to the lists. That same year, the Office of the Inspector General (OIG) also issued a report on registries that was uncomplimentary.
Then, in 2005, the Division of Transplantation convened a working group of OPO professionals to provide guidance on how the government could best help advance registry development in the States. The group recommended the provision of grant funding for States to develop or improve a registry or conduct public education to encourage registry enrollment. It also recommended a registry national best practices meeting. Following the group’s recommendations, the Division launched a grant program for registry development and improvement. The Public Education Program, which supports a variety of educational and public outreach efforts to inform the public about organ and tissue education, will be conducted this year. It is hoped that both of these programs will continue in 2008. The best practices meeting did not occur, however, because most of the things that would have been promoted are already happening.
The impact of registries has been that the percentage of total donors who are in a registry, ranges from 40 (e.g., Colorado) to 70 percent (e.g., Utah). This increased donation and the result is that most of those who die, and are medically eligible, become donors (compared to just 50-60 percent of those not in the registry becoming donors). The qualitative impact of registries is that donors are assured their wishes will be honored, and families are comforted by the certainty of the donors’ choice. In terms of the donation process, the family approach and recovery both happen sooner; more organs are viable for transplantation; hospital bills are lower, due to less OR time; and beds are cleared faster for incoming patients.
Recommendations from Division grants are that successful State registries need legislative support, a commitment to honoring the first person consent; access by designated procurement or referral organizations; 24/7 and web-based capabilities; training for procurement staff in interacting with families of donors who have given first person consent; and community-wide support and cooperation. Cost is less of a challenge, as there are now models that can be replicated. Challenges include establishing a critical infrastructure; implementing and measuring the impact of programs and outreach efforts; formalizing systems for information reciprocity among States; and fostering enrollment.
David Marshman spoke about Virginia’s LifeNet’s experience with first person consent and donor registries. LifeNet serves about 4.7 million individuals, close to 80 hospitals and 4 transplant centers. Geographically it covers Fredericksburg at the northernmost point, the North Carolina border to the south, Virginia’s eastern shore, to the east; and Martinsburg, West Virginia, to the west.
In 2001, Virginia law changed to mandate that the donors’ wishes be strictly enforced. LifeNet began accessing the DMV data in cooperation with the DMV and with assistance from the Virginia State Police, to check the donor status on Virginia drivers’ licenses for deceased patients who were referred for organ and tissue evaluation. The main concern at the time was over the potential push back in terms of resistance from donor families who did not agree with the patient’s desire to be an organ donor, and from hospitals that feared litigation. The reality was that neither concern posed much of a problem. Most families were supportive, especially when they understood the donation process and that the families were honoring their loved one’s wishes. Families were supportive and felt relief that they did not have to decide because the loved one had already decided.
There were originally four options (yes, no, refused, undecided). What posed the biggest problem for them was what to do with those who had responded “no.” It was not clear if this was an informed no; and what should be done if the family brings up donation only to learn there is a “no” listed on the driver’s license. The organization worked with the DMV Commissioner’s office and received confirmation that, for many years, the DMV system had been binary. The default was a “no” if someone had not been asked or if a mistake was made. They felt, of course, that it would help donation if the opposite applied.
Virginia applied experience from other States, such as Pennsylvania, to implement its program. In 2003, the official State registry Web site went up, which helped solve the issue surrounding what to do with the “no”s from the DMV database. Virginia is an opt-in registry, so the “yes” responses were put into the database. In 2006, the DMV remains a major portal (99.6 percent of sign ups are through the DMV), while less than one percent have registered on-line.
Efforts are focusing on education targeted at high school sophomores and juniors, since they are just getting their licenses and are in driver’s education classes. Discussions of donation are now also included in the State Standards of Learning. Parental consent is needed until they are 18. If a teenager is in the registry, they still talk to the families. Currently, three percent of the registry donors are younger than 18. In terms of the impact of registry, the percentage of donors who are in the registry has increased from 36 percent to 75 percent.
Mr. Holtzman asked if there have been any efforts to link State’s registries to gain common access. Dr. Ganikos responded that Dr. Jim Burdick is very interested in this idea. There is an informal system in place currently. The Association of Organ Procurement Organizations has a list of registries and contact numbers, so it can be accessed if the person lives in a State with a registry.
Dr. Low asked if, other than the 97 percent who are on the registry, the rest are families that said no. Mr. Marshman said that Virginia has looked at this on a case-by-case basis. One was a case in which the woman hadn’t understood English very well and may not have known what she was signing. The family felt she hadn’t understood the donation, so they withdrew. One commenter noted that he had been the first person to routinely honor first person consent. He had had three cases in which the family pushed back, but the donations happened. In all cases, the family said they would sue. However, two families actually came back and said they were actually happy that the person’s wish had been followed although they couldn’t see it at the time.
Dr. Leffell asked about the States that don’t have registries and if they will move ahead. Dr. Ganikos said it is unclear why some States have not done it. She would think about what ACOT might do. It’s highly likely that the grant program for developing or refining a registry will not be offered after 2008.
Dr. Vega expressed concern about the database containing so much personal information in it, and the safeguards that exist. Ms. Conrad noted that the driver’s privacy protection act deals with this; no social security numbers are included. In terms of being able to do research, for example, if there is a commercial promoting donation, they can go back and look by zip code to see if it has worked. The data are really useful for assessing results.
Dr. Ganikos said that she was proud of how Virginia has done the registry and noted that it’s covered in the driver’s instruction manual. There has been a long relationship with the AAMV and a model manual for how States can promote organ donation is planned. States may want to put other topics into their manuals, but at least we can provide a sample for them to use. It’s also on the AAMV Web site.
Dr. Low said that the 97 percent conversion rate is impressive. If the other three percent had already consented, why is there not legal protection in these cases? In Virginia, there is the ability to talk with the families; and we may encounter a situation in which the person has changed his/her mind. There is a clause in the law to cover that. If two people can confirm that the individual had changed his/her mind, it’s okay to do so. The one that always comes to mind is that the person watched some television show and then decided to change his/her mind because of misinformation. Ms. Conrad said that her facility had an experience like that. The family really objected, and the hospital didn’t back them up so they had to walk away. Ms. Agrawal commented that the UAGA says if you attempt compliance in good faith, you have legal immunity, so a lawsuit wouldn’t succeed. The State would have to have enacted the UAGA with that component. Ms. Levine added that some of these cases could be with minors who can’t legally give consent, yet.
Dr. Wiesner asked how many States have high school programs focusing on high school students in health education and driver’s education classes. He felt it was very impressive and was where the field should be focusing. Dr. Ganikos replied that the program content was developed by the Division’s resident educator, and it was part of Secretary Thompson’s educational campaign. A copy was distributed to every high school and school system (both public and private). We get grant applications saying that folks are using it, but I can’t be more specific. Two Canadian provinces also want it for their high school driver’s education programs.
Audience member, Ms. Luebke, commented that there’s a club for college-aged students (18-22 year olds). It’s a student action group to promote organ donations, and it might be a good linkage to involve them. Dr. Ganikos totally agreed. If you make a presentation at a high school, you can get 150 children to sign up at once. It’s really important to address people before they get their first license. Ms. Agrawal agreed that the goal is to create a culture of donation among young people.
Review of Past Recommendations – Mr. Remy Aronoff
Mr. Aronoff reported that the ACOT member packages include a list of all recommendations that have been made since 2002, and what’s happened as a result of them. The ACOT was established at the end of the Clinton Administration, and its first meeting was held later that year (December 2001). No recommendations were made in the first two meetings. At the third meeting, 18 recommendations were made, and at the fourth meeting, 10 were made. More than half of the recommendations have involved OPTN, CMS, and HRSA. The HHS Secretaries to whom the recommendations have been made have accepted all of them.
If you look at the categories of recommendations, living donors have the most recommendations. Areas of concern include ethical principles and informed consent standards; independent donor advocate; database of all live donors; a resource center; preference for living donors as transplant candidates; deletion of HLA typing requirements; verifying qualifications of living donor centers; and creation of a living donor registry. Looking more closely at a few of these living donor recommendations, there is no database as yet, but the OPTN is collecting 6- and 12-month follow-up on all living donors. There is also a plan to add 2-year follow-up. There have been problems with donors who are lost to follow up. Now, work is going on with paired exchanges.
At the November meeting, the ACOT made three recommendations:
|#43.||The ACOT recommends to the Secretary that the Medicare program allow direct organ acquisition expenses for DCD recovery to be reimbursable to the OPOs under the Federal program.|
|#44.||The ACOT recommends to the Secretary that he promote collaboration between the transplant community and the insurance industry to adopt standards of coverage for living organ donors specifically relating to future adverse events resulting from the donation.|
|#45.||The ACOT recommends to the Secretary that he take action intended to provide Medicare eligibility for any living donor who loses insurability as a result of disability on the basis of previous organ donation.|
The last one, #45, requires an amendment to the Social Security Act. This is being worked on, but it’s not clear if this will happen.
Dr. Scantlebury asked how the recommendations are delivered to the Secretary. The response was that the Secretary gets them in written format from the Chair of ACOT. The Secretary then responds saying that he has accepted them. At that time, the Division of Transplantation starts working on contacting whoever needs to know in order to move on the recommendation(s). There’s never direct communication with the Secretary, although Secretary Thompson came to meetings during his term. Ms. Agrawal noted that members can look at the recommendations and also check the website, which includes information going all the way back to the beginning.
Ms. Agrawal stated that, after this meeting, the Committee should identify the ongoing workgroups. She asked that Mr. Aronoff follow up after his review of the summary notes and then we can follow up with everyone by email. Mr. Aronoff reported that there appears to be one workgroup on tissues; two workgroups on living donors; and one on transplant tourism.
Dr. Wiesner commented that members have heard from almost every speaker that there is a need for more data, but it’s necessary to ask who will pay for it. He asked if there could be a workgroup to addresses reimbursement for data collection from the transplant centers. Ms. Agrawal agreed to this idea. The workgroup could address the data points needed but not available so ACOT can advocate for them. She stated that we don’t have the data because we don’t have a payer. CMS data are available, but not data from private payers, although they use the data.
Dr. Lorber said that another issue to consider is the longitudinal, living donor registry that includes outcomes. We have already made a recommendation on this, but it’s not been acted upon. He thinks the ACOT should remind the Secretary about this issue and reiterate the Committee’s sense of the need for it. Registry data are expensive. Mr. Aronoff reported that the NIH is doing studies on kidney and liver donors. He suggested having NIH present on the studies at the next ACOT meeting and discuss how a “registry” differs from what UNOS wants to do. An NIH representative stated that they are presently at the end of the first year of a collaborative looking at long-term outcomes for kidney and lung donors. In terms of kidney donors, protocols have been drafted to look at retrospective issues and see who they are and how they are doing. NIH is presently doing cross-sectional, short, prospective studies, so donors can be approached to come back for outcome data.
Dr. Lorber said that these data will be invaluable in terms of outcomes, but they do not address the substantive issues that a living donor registry will address. He repeated his assertion that there is a need for registry to assess the consequences of living donation. Mr. Aronoff stated that OPTN is having lost-to-follow-up problems with the short-term follow-up. Dr. Lorber replied that does not minimize the importance of the information, if we are intending to continue promoting living organ donation. Ms. Agrawal said that a workgroup can create substantive recommendations on how to do proceed with an implementation strategy.
Ms. Conrad thought that, if we are changing kidney donation and using LYFT, it’s likely that living donors will be coming out of the woodwork. We need to know how this will work for the donor. Dr. Wiesner commented that Sweden has 30 years of follow-up and the field has changed in that time – accepting obese donors, hypertensive donors – and the donors are very different. If we look backwards, it’s not necessarily going to tell us about the future risks, given the changes. Ms. Agrawal said that AHIP can come and talk to ACOT and see how they can help. Hopefully, a estimate of the costs can be determined.
Mr. Holzman added that the issue of the “inactives” on the list could be another workgroup. Ms. Principe said that allocation issues are always before us. Given the current state of allocation, why isn’t the geographic piece of allocation part of the Kidney Allocation Review System (KARS) process? Dr. Wiesner replied that it’s not linked to KARS; geography is a separate issue. If we can share organs more broadly, there will be less renal failure. It’s States versus Federal rights, which no one has wanted to address. If you are across the border, you may not get a liver. Ms. Principe stated that UNOS regions were originally set up for administrative purposes, but they have been become part of the allocation system CMS set up. Dr. Lorber said that the corollary is that, so long as a standard unit of organ allocation is a non-standard entity (OPO), it isn’t possible to have a truly equitable strategy. The unit is a different number.
Dr. Zhu stated a concern about the allocation strategy. If you base allocation on statistical models, you can have several statistical models that do equally well, but which have different policy implications. What models have been developed by SRTR and what is available? You will discriminate, but to what extent is that discrimination unequal?
Dr. Leffell added that in terms of live donors, a workgroup can also look at the idea of having a review panel for adverse events available to donors and families.
Public Comment --
Ms. Luebke from Metro Health Medical Center shared that she is pleased about the results of this ACOT meeting and the emphasis that has been placed on donor’s safety. In the course of their work as donor advocates, they are being called watchdogs. However, the ACOT also is a watchdog for the transplant community. Ms. Luebke shared a few points of concern about paired donation. The kidney program strongly voted down the OPTN proposal for a national paired exchange program in over half of the regions. There are large paired donation programs already in existence in the U.S. (for example, the Paired Donor Network which has over 100 members with signed HIPAA agreements).
Ms. Luebke asked the ACOT to seek an investigation of Johns Hopkins for the actions that were portrayed on the Discovery Channel (and which is available on DVD for members to review); namely, that anonymous donors, Internet-solicited donors, and foreign nationals are being used for these donations. OPTN Ethnics Committee should be involved in such an investigation, as should other appropriate ethics committees and the Secretary of HHS.
Ms. Luebke asked ACOT members to watch the Discovery Channel program on the three-way swap at Hopkins. Two persons involved in the Hopkins procedure had been deemed not to be good candidates for donation by other programs. She closed by reminding ACOT members that we all have a duty to protect both the reality and the public image of donation, donors, and the candidates.
The meeting was adjourned.
ACOT’s next meeting will be held on November 15-16, 2007.