Advisory Committee on Organ Transplantation

Advisory Committee on Organ Transplantation (ACOT)

Hilton Rockville Hotel
Rockville, MD
May 15-16, 2007

May 15, 2007

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.

Discussion --

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 Matching donors.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:

1. Have written donor management policies for the donor evaluation, donation, and discharge phases of living donation.
2. Ensure that each living donor is under the care of a multidisciplinary patient care team coordinated by a physician throughout the donor evaluation, donation, and discharge.
3. Make available social services furnished by a qualified social worker available to living donors.
4. Ensure that nutritional services are available. (This and the requirement for social services were added because End-Stage Renal Disease (ESRD) regulations include these requirements.) All types of donors are under one regulation now, including kidney donors. The goal is that living donors should receive no less, in terms of care, than the recipients.

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.

Discussion --

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.

Public Solicitation

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:

• The ACOT recommends to the Secretary that he direct the OPTN to develop and distribute within the transplant community, particularly to transplant programs and OPOs, a set of practice guidelines to be followed with respect to public solicitation of organ donors. The objective of these guidelines is to maintain the effectiveness and fairness of the existing organ allocation system.

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.

• FINAL RECOMMENDATION (public solicitation for living and deceased organ donors): The ACOT recommends to the Secretary that he direct the OPTN to develop and distribute within the transplant community, particularly to transplant programs and OPOs, a set of practice guidelines to be followed with respect to public solicitation of organ donors. The objective of these guidelines is to maintain the effectiveness and fairness of the existing organ allocation system and to protect the safety of the living donor.

A motion to adopt the recommendation was made and seconded. There was no discussion. The vote was unanimous.

Tissue Regulation

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:

1. Any agency or organization that recovers organs and/or tissues for human transplantation within the United States must be registered, inspected and certified to do so by the U.S. Department of Health and Human Services or its designee.
   
2. Any agency or organization that recovers organs and/or tissues for human transplantation within the United States must be accredited by Association of Organ Procurement Organizations (organ), American Association of Tissue Banks (AATB), or the Eye Bank Association of America (EBAA).

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:

• There may be an increase in global contracts with long post-transplant coverage periods, and/or an emphasis on shifting financial risk from payers to providers for DCD and other high DRI donors.
• Regulatory reform may be needed to ensure that transplant centers are adequately reimbursed. The “push” of the HHS Organ Donation and Transplantation Breakthrough Collaboratives will stall, if there is no “pull” for marginal donors. The “pull” will be weak if centers consistently loose money on marginal donor transplants which is likely the case today.

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?

Discussion –

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 decid