November 13, 2008
Welcome & Introductions
Mr. Aronoff welcomed the group and asked members who would not be attending the meeting on November 14th to alert him in order to ensure a quorum for the meeting. He announced that Dr. Jim Burdick, Director of DOT, has retired; the Acting Director is Richard Durbin, who has been the Deputy Director for the last four years. ACOT Chairperson, Ms. Gail Agrawal, welcomed everyone as well.
Review of ACOT Recommendations & Suggestions for Orientation of New Members: Mr. Remy Aronoff, Executive Secretary, ACOT
Review of ACOT Recommendations
Mr. Aronoff handed out a list of all ACOT recommendations made thus far and discussed them. The most recent recommendation was sent to the Secretary but staff has not gotten a response yet. In total, HRSA’s 13 Advisory Councils and Committees have made 494 recommendations since 2001. The ACOT meetings have fluctuated in terms of the number of recommendations made: in November 2002, it made 18 recommendations, while in May 2005, it only made one. In terms of categories, recommendations on living donors were the most frequent (12), followed by those on research (5), reimbursement (3), public education (3), and the UAGA (3). There are 19 recommendations categorized as “Other” which include one-time recommendations such as #22, on split livers.
The first living donor recommendations were on support for ethical principles and informed consent standards, independent donor advocates, a database of health outcomes, resource center, allocation preference to prior living donors, elimination of unnecessary HLA typing of living liver donors, and qualifications of a center to perform living donor transplantation. Other living donor recommendations include support for development of allocation policy pertaining to non-directed living donor organs (#41); a registry for matching living donors and recipients (#42); collaboration between the transplant community and the insurance industry regarding coverage of future adverse events (#44); Medicare eligibility for living donors who lose insurability as a result of previous organ donation (#45); and data collection on the health status of living donors (#46).
In terms of outcomes, the Organ Procurement and Transplantation Network (OPTN) Board and others have reflected these recommendations in their own policies, including:
Discussion of Draft Agenda for New Members’ Orientation
Mr. Aronoff sought members’ opinions about potential items to include in the orientation for incoming ACOT members (nine new members come on in May and six more over the rest of 2009; total turn-over will be three-quarters of ACOT members over the next 12 months).
Ms. Agrawal suggested that it would be useful for new ACOT members to understand what they can recommend and what the scope of the Secretary’s authority is. Dr. Velma Scantlebury would like for the ACOT members to have an opportunity to meet the Secretary. Members suggested including information about how recommendations are presented to the Secretary. Mr. Aronoff clarified that staff send recommendations to the Secretary’s office and receive a letter saying they have been accepted. The quantity of recommendations from the over 200 HHS advisory committees makes more specific feedback unlikely. In general, the recommendations often connect to OPTN and staff communicates with that organization about the recommendations. Ms. Suzanne Conrad said it was good to get an overview of the recommendations and know that it is acceptable to end an ACOT meeting without making any recommendations.
Ms. Agrawal reminded the group that, while ACOT makes recommendations to the Secretary, other entities and staff also read them on the organ donor.gov Web site. Many UAGA changes stemmed from ACOT’s work. The conflict between the Institute of Medicine and ACOT about presumed consent has generated a lot of important comment in the legal/policy community as well. The dialogue generated by ACOT’s work is very important to this field and plants seeds that flourish in interesting ways.
Ms. Anita Principe expressed surprise that the transplant community does not perceive ACOT as an advisory group or think tank. Dr. Mary S. Leffell added that many people do not know that ACOT exists. She recommended that staff circulate names of members so they can be contacted. Dr. Frieson commented that he receives a lot of email about transplant tourism and that people know ACOT has worked on this issue. He felt this was one issue where ACOT’s public views have made a difference.
Mr. Samuel Holtzman commented that ACOT’s role is to shine a light on best practices and that this has been done well. The Breakthrough Collaborative is one example and is being replicated privately (e.g., the Alliance). Dr. David Conti agreed with Ms. Principe that many in the field do not see ACOT as an advisory body; instead, they look to UNOS, OPTN, and the American Society of Transplant Surgeons. He suggested fostering cross-fertilization with those groups. Mrs. Rhonda Boone said that, as a lay person, it has been frustrating that nothing seems to happen as a result of the recommendations. She urged the ACOT to maintain a wide variety of members (not just transplant surgeons) to represent a variety of viewpoints.
“Tools” Available to the HHS Secretary for Implementation of ACOT Recommendations; Ms. Emily Marcus Levine, Office of the General Counsel, DHHS
Ms. Levine’s presentation emphasized the points made by Ms. Agrawal about the role of ACOT and the Secretary. She commented that ACOT is held in high esteem at HHS, has been persuasive, and had a bigger impact than other advisory committees with which she has worked.
Ms. Levine described ACOT’s role as being to give advice to the Secretary. ACOT has a broad mandate. If members believe that an issue affects organ transplantation (such as tissue transplantation), it is appropriate for consideration. Ms. Levine described what happens after a recommendation is made. Most typically, it is “considered,” which has an impact on staff’s work. Sometimes the Secretary will endorse legislation. If the ACOT has recommended a particular piece of legislation, it is persuasive. Internal options for HHS, if legislation is not required, include considering Government policies and priorities, adopting new materials, and sponsoring meetings. Working groups can look at ACOT’s recommendations and use them to set priorities (the Breakthrough Collaborative is one example). External options when rulemaking is not required include asking OPTN to examine specific issues, creating deliverables (like brochures or public information), and making grants.
Ms. Levine’s perspective was that it takes a long time for things to happen but, just because members do not see an immediate endorsement, does not mean there has not been an impact. ACOT recommendations have a big role and the members are appreciated.
Ms. Agrawal suggested that this presentation would be a good component for the new member orientation. She commented that, in ACOT’s early years, it did a lot of work on paired exchanges and whether they were prohibited under the National Organ Transplantation Act. The issue was resolved through intra-agency work between the Department of Justice and the Health Resources and Services Administration by staff who relied upon ACOT’s work. Paired exchanges and exchange chains were made possible by the work of ACOT. Having ACOT’s experts endorse an issue helps create political will.
Ms. Principe clarified that her point was that ACOT would be well-served by having more natural partnerships and collaborations with other entities in the transplant world. For example, Ms. Conrad’s membership on the OPTN’s Living Donor Committee enhances the communication and feedback ACOT receives.
Dr. Richard Migliori asked for information about why ACOT was formed, which Mr. Aronoff provided. Ms. Levine added that, at the time, allocation policies were controversial; and when ACOT was formed, it was expected that it would be asked to give feedback on allocation and other policy changes. Mr. Aronoff stated it was later determined that requiring ACOT recommendation on policy changes would be too time-consuming, especially because many polices were time-sensitive.
Mrs. Boone asked about ACOT’s future. Ms. Levine reported that the current charter lasts until 2010 and could be extended.
Report on the New York State Transplant Council, Committee on Quality Improvement in Living Kidney Donation; Dr. David Conti, Director of Transplantation, Albany Medical College
Dr. Conti described the work of the New York State Transplant Council’s Committee on Quality Improvement in Living Kidney Donation. New York is the only State where the Region (9) and the State are the same, enabling New York to enact policies for UNOS within a very specific region.
As background, Dr. Conti described a four-fold increase in donors who lack a relationship with the patient. The Department of Health (DOH) received many calls from transplant centers seeking advice about these “non-traditional” donors. New York’s Transplant Council has been very successful and, in 2006, convened a committee to develop a guidance document for live kidney transplantation with the goal of providing consensus among clinicians on how to deal with this growing and increasingly complex issue. The Committee’s many members included physicians from all of the State’s transplant centers and a range of outside experts.
The Committee formed three sub-committees: (1) to examine evaluation of donors medically to ensure the welfare of potential and actual living kidney donors; (2) to examine the evaluation of donors non-medically to develop guidelines for donor advocacy, informed consent, psychosocial evaluation, and long-term follow-up to protect the well-being of living donors; and (3) to examine evaluation of donors without a biological or emotional relationship with the recipient to ensure that each donor (regardless of their relationship to the recipient) receives appropriate evaluation and advocacy.
Dr. Conti described the highlights of the Report on the New York State Transplant Council, Committee on Quality Improvement in Living Kidney Donation. For example, the Committee decided that each live kidney transplant center must have a Donor Advocate Team (DAT) and specified the team’s activities, characteristics, and responsibilities. It described the components of informed choice and informed consent. The Committee accepted the minimal screening guidelines from the Amsterdam Forum on the Care of the Living Kidney Donor (March 2005).
For non-traditional live donors, the Committee looked at three types of sources: donors who were identified through media efforts, swaps, and the anonymous or Good Samaritan donor. It determined that it is the responsibility of the transplant centers, facilities, and doctors to follow U.S. laws prohibiting the sale of organs. It noted that solicitation was a particular concern in cases with a non-traditional donor, given the risk of misrepresentation of medical need and other complications that impact informed consent. The Committee determined that the donor must be fully informed of a wide variety of information about the recipient. The solicited donor must have a comprehensive psychosocial evaluation of a number of factors, including the availability of someone to care for the donor post-surgery. The Committee addressed the potential for covert compensation with a non-traditional or solicited live donation. It stated that, for altruistic donors, a mandatory waiting period between the offer and the donation was appropriate, but did not set a specific time frame.
The Committee strongly recommended that the State establish a registry to conduct long-term follow-up on live kidney donors.
Mrs. Rhonda Boone congratulated Dr. Conti for this accomplishment and asked if the donors were evaluated at the donation center. Dr. Conti confirmed this, commenting that the donors have to be aware that they may have to travel to the transplant center for the transplantation. The DAT has to give acceptance for the transplant. If the DAT recommends that the person not be a donor, there has to be a strong rationale for the transplant team to proceed.
Dr. Scantlebury asked how the 9-month wait time was determined. Dr. Conti said that it was not prescriptive; that’s just how long it took to process/screen these donors. It was one-third longer than the process with a related donor. The donor meets with Dr. Conti and is asked to return with his or her significant other(s). Usually the significant other has no idea the donor has this intention. The donors also meet with the primary care doctor to get a clean bill of health. They have the medical evaluation and psychosocial evaluations; then there is testing. Finally, it is presented to the hospital ethics committee. Only then is the transplant scheduled.
Ms. Principe noted that Medicare regulations state that live donors are eligible for coverage and that the center has to ensure routine care for 6 months which is covered by Medicare. She asked how ACOT could advance this. Dr. Conti responded that the guidelines describe unforeseen complications which can arise from having a live donor, and noted the lack of good data to describe live donors. The Committee’s task was to ensure that the donor was told about the uncertainties and was able to provide informed consent.
Dr. Leffell said this was a model that the rest of the country could follow. Centers are very interested in paired donations, and have found that many donors have access to a person who can explain the risks and consideration of paired donation vs. another process. Dr. Conti agreed that the guidelines include potential alternatives (e.g., desensitization) but did not specify who would provide that explanation. Patients receive a huge amount of information and it can be hard for them to understand it all.
OPO Quality Assessment & Performance; Mr. Charlie Alexander, Executive Director, Living Legacy Foundation of Maryland and Mr. David Marshman, OPO Quality Systems Manager, LifeNet Health
Mr. Marshman, OPO Quality Systems Manager, LifeNet Health
The Association of Organ Procurement Organization’s (AOPO) Quality Improvement Council recognizes the importance of sharing best practices throughout the communities and bringing them to the OPOs. Mr. Marshman described the Quality Improvement Council’s work, which is to serve as a forum to address issues related to quality improvement of the donation process.
The AOPO Executive Committee’s charges for the Council for 2008-09 are to:
The intent of this formal linkage is to ensure the data collected are clear and consistent across OPOs. The goal is to ensure that the industry received targeted training on quality assurance to focus on increasing organs, efficiencies. Mr. Marshman described sharing of feedback to make OPOs better, and AOPO’s interest in a methodology to increase OPOs comfort with sharing audit results confidentially. Because most OPOs are accredited by several sets of standards, AOPO is creating a reference guide covering all of these standards so that OPOs can look in one place and see how well they are meeting these standards. The Council is assisting in the process of revising AOPO accreditation.
Mr. Marshman described specific quality improvement activities in the industry which include regionalization of donor management goals; focused efforts on donor management to increase organs transplanted per donor; process improvements to increase individualized consent rates; quality documentation of customer service between OPOs and hospitals; and increased organizational initiatives in quality.
Mr. Alexander, Executive Director, Living Legacy Foundation of Maryland
Mr. Alexander described the way that one OPO utilized national efforts to improve its work by learning more about potential donors. This effort was sparked because the OPO had never had good response to follow-up efforts with those who declined donation and wanted to learn more about these individuals. It also sought information of those who did not meet the definition of “eligible.”
Mr. Alexander gave a demographic overview of Maryland, a State with a population that is 70% White, 20% African American, and 6% Hispanic. While those percentages seemed to mirror the Foundation’s clients, they actually did not. Research indicated that the organization focused its outreach activities at the wrong end of the State and was mistakenly working harder in the west than in the east. Further examination of data revealed that about 65% of Maryland’s donor potential is in Baltimore, which is 80% African American.
As a result, the organization changed its resources and methods for conducting public outreach campaigns. The conversion rate for African Americans went from 40% to 65-70%. The organization learned that formal processes for reaching communities did not work in inner-city, African American communities. It needed to work more closely with informal leaders, community leaders, and churches. It also discovered that individuals did not die at hospitals near where they lived. Decisions about donation were actually being made in communities far from the hospitals where the patients died.
Culture is formed in the community, not the ICU. The Foundation now focused on both providing good care in the ICU and building community-based hospital plans and including them in the process. The organization learned that small community hospitals were not seeing the transplants but their patients were being transferred elsewhere and were potential donors. The organization changed efforts and now works with, and reaches out to, small community hospitals to enhance community views. Adding a cultural diversity component to the organization’s plans was important and has led to focused efforts to conduct outreach within the small community hospitals.
Mr. Tommy Frieson asked Mr. Alexander what programs his organization had used in the inner city to improve donation rates. The response was that the organization worked to dispel myths and share information about what happens when people do not share. It reached out to churches and the religious leaders, who began to identify community members who were waiting for donations. This made the issue of donation more personal and less abstract.
Ms. Principe asked if AOPO membership is required of OPOs. The answer was that all OPOs are AOPO members, but not all are accredited. The speakers clarified the difference between an association and a regulatory body: the former helps share best practices and all OPOs participate; the latter is outside AOPO’s purview. Strong regulatory initiatives are on-going at other places, such as UNOS.
Ms. Conrad announced that she is the president-elect of AOPO. She said that there was huge variability in the field nationally and that OPOs are regulated. New CMS guidelines will be issued and OPOs will be held to different standards in the future. She described the complicated reasons why an OPO may not be accredited: some are hospital-based and the decision about accreditation could be regent- or board-driven, for example.
Mr. Holtzman asked if Mr. Alexander was able to identify a concentration of potential donors in certain hospitals. The answer was affirmative; the organization was struck by the fact that people came in from service areas where they had not spent much time. They now focused on the hospitals those people came from, maintained in-house coordinators at the largest potential donation hospitals, and spent time in second-tier hospitals as well.
OPTN Strategic Plan; Mr. Walter Graham, Executive Director, UNOS
Mr. Graham discussed the OPTN’s advocacy and policy focus for its Board and committees. The OPTN contract calls for long-range planning for changes over the course of the contract. In October 2005, the Board began to articulate activity and policy focus areas for the committees to ensure that priority issues were addressed. Mr. Graham referenced the OPTN vision statement, adapted from the Commonwealth Fund’s Framework for a High Performance Health System. The Board sets OPTN’s strategic priorities and goals. These major focus areas did not, however, cover all of OPTN’s work. OPTN’s long-range strategic goals and priorities were to:
Mr. Graham described examples from the various OPTN committee activities on oversight and patient safety, and organ allocation.
Mr. Graham noted that there are 58 DSAs in the U.S. These allocate locally first and then to the region. He illustrated all of the allocation changes made after the 1999 Final Rule was issued and noted proposals that are in development to illustrate the future of the field. He described the field’s impressive accomplishments since 2001, including MELD and PELD variance; elimination of HLA-B matching points; changing sequence in heart allocations; implementing Share 15 for livers; and broader sharing of pediatric organs.
On the donor shortage, the OPTN will support the HHS program goals and maximize the number of donors and transplants. Examples of committee activities this year included development of national paired kidney donation program and policies; development of OPO performance metrics; and development of improved organ utilization and wastage metrics for public reporting.
On operational effectiveness, the OPTN will identify process and system improvements that best support critical network functions, and work to disseminate them to all members. Examples of committee activities this year included developing consensus and evidence-based histocompatibility guidelines as needed for a national paired kidney donation program.
On fiscal responsibility, the OPTN will take into account the financial impact on OPTN contractor operations, OPTN members, and the network in adopting new requirements. Examples of committee activities this year included each Board action item having a resource impact statement to estimate implementation and ongoing maintenance costs.
Dr. Migliori asked about tactics in the safety strategy. The response was that disease transmission was the short-term primary focus. OPTN’s Operations Committee examines patient safety, and its Disease Transmission Advisory Group advises that Committee. The Committee is developing measures on potential and studying issues, reporting cases out. There has been an increase in reported disease transmission, including cases of cancer.
A representative from the National Kidney Foundation said that he appreciated the review of ACOT’s achievements and legislative actions. He highlighted two pieces of legislation introduced into the 110th and 111th Congresses: HR1035, which provided tax credits for living donor expenses, and HR2808, which amended the Family and Medical Leave Act to ensure coverage for living donors.
Status of OPTN Living Donor Follow-up; Dr. Matthew Cooper, Chair, OPTN Living Donor Committee and Mr. Walter Graham, Executive Director, UNOS
Dr. Cooper, Chair, OPTN Living Donor Committee
Dr. Cooper began by noting that the UNOS Living Donor Committee became official only several years ago and described its representation. One-third of the Committee members were themselves living donors and had perspectives the surgeons and other providers could not replicate. Dr. Cooper described the creation of the Committee, the living donor registry, and follow-up forms. The forms became effective in March 2008 and complete 2-year follow-up data will be available in 2010.
Dr. Cooper described recent activities, which included enacting new bylaws that stated strongly that the living donor advocates have the same weight as transplant surgeons, and that living donor advocates should never be overruled by doctors. Other bylaw changes specified medical and psychosocial evaluation of living donors, required protocols for obtaining informed consent, and notification that the center will seek follow-up information post-donation. OPTN was finalizing medical evaluation requirements for living donors and other resource documents.
In terms of follow-up, OPTN was working to ensure that donors know the centers are required to conduct follow-up at 1, 2, 6, 12, and 24 months post-transplant and to encourage donors to visit their doctors. OPTN also was working with centers to improve the number of donors “lost to follow-up.” Previously, it was acceptable for a donor to be reported as “lost,” but this was no longer the case.
Dr. Cooper illustrated the number of living kidney donor forms submitted in 2006. Regardless of the number of transplants performed, or the center’s reputation, there were still deficiencies in the data. For one in every five kidney donors in 2006, there were no forms submitted. For liver, there was more follow up and less loss of data. OPTN can now look at each center and see how many donors were lost to follow-up. Despite the high quality of the center’s work and good outcomes in the SRTR database, large numbers of donors are still being lost to follow-up.
Mr. Graham, Executive Director, UNOS
Mr. Graham began by describing why it was important to collect living donor follow-up data and commenting that the data collected to date do not answer all of the questions on long-term complications, pre-donation issues, perioperative conditions, and financial complications. Mr. Graham discussed the timeline of living donor follow-up activities. The precursor to SRTR was established in 1987, but follow-up was not included in data collection activities until 1999. The follow-up form was created in 1999 to assess at 6 and 12 months post-transplant. All living donor forms were expanded in June 2004 to include information on pre-donation insurance and functional status, post-transplant complications, and detailed cause of death.
In March 2008, additional changes were made to the discharge form to address the issue of centers reporting the donors as “lost to follow-up.” Changes to the discharge form included the requirement to report detailed information about how the donor was followed, including the date of and the living donor’s status during the most recent contact between the donor and the recipient transplant center and whether living donor organ recovery and transplant occurred at the same center. At the same time, the 2-year follow-up form was approved. From now on, centers must provide living donor follow-up at 6, 12, and 24 months post-transplant.
Mr. Graham described the kidney data, noting that the data become less complete as time passes. For kidney donors, data indicate that complications at 6 weeks post-transplant are rare. By 6 months, complications data are 17% incomplete; by 12 months, data are more than 50% incomplete. About one-third of kidney donors were reported as lost to follow-up during the first year post-transplant. Mr. Graham discussed adverse events and noted that one death was reported from donation-related causes within 6 weeks of donation, out of 19,000 donations performed from 2005-2007.
For liver, the complication rates were fairly complete and low. Data tracking was better. By 6 months, complications data were less than 10% incomplete; by 12 months, data were less than 20% incomplete. A small fraction of liver donors were reported as lost to follow-up during the first year post-transplant.
Mr. Graham addressed why data were missing and described OPTN’s path forward. The OPTN/UNOS Living Donor Committee has been charged by the OPTN leadership with developing one or more living donor program performance metrics. To this end, it must address the issue of data completeness. The Data Subcommittee of the Living Donor Committee is developing plans to improve and report short-term data and to address options for long-term data.
Mr. Frieson asked about ACOT’s recommendations #47 and #49 on tracking U.S. citizens who leave the country for transplants (e.g., transplant tourism). The speakers reported that OPTN was working on a reporting system for persons after a foreign transplant, but this was not yet in effect. Mr. Frieson asked about ACOT’s recommendation #49, which recommended a centralized entity that could record the long-term status of living donors and ensure data are not lost. OPTN representatives said the only process like this was a self-reporting system at Wake Forest where people could submit their own data. Dr. Cooper said that OPTN was interested in exploring sanctions to impose on those who are non-compliant with the data collection mandates.
Ms. Principe suggested conducting a national patient satisfaction survey process to proactively collect information about live donors, complications, and quality of life. Dr. Cooper said that it was a worthy idea, but would encumber the centers with additional data reporting requirements. Living donors tend to be uncomfortable going back if they have a complication, which skewed the numbers. He felt that donors might be more honest if their responses did not go to the centers. Mr. Graham suggested that OPTN may not be the right organization to do such activities because it was controlled by the institutions, a fact that might make donors less confident than reporting to an independent entity. He added that the feedback would have to be checked, too, because it might not be fair.
Dr. Conti asked if the live kidney donor complication rate had increased. Dr. Cooper said that he could not speculate. He felt that centers do not report the donors with complications. Complication rates have not changed much over time, but the data may not reflect what is occurring. The centers may not know about complications or may minimize them. Dr. Conti reported that the New York Department of Health had sent donors surveys about their experience and only about 30% completed the forms.
Mrs. Boone asked how OPTN ensures that the data are accurate. Mr. Graham reported that the UNOS on-site reviews compare medical records to the data submitted by the center and looks at living donor data and conduct spot checks to see if data are accurate. If they are not, there are very severe sanctions, e.g., one center had data problems that caused them to become a “member not in good standing.”
Reports from Workgroups; ACOT Members
Living Donor Advocacy/Post-Donation Complications, Ms. Anita Principe
Ms. Principe reported that the workgroup formed about 9 months earlier and had asked that this meeting’s agenda include a presentation from the OPTN Living Donor Committee and an update on New York’s work on living donors. An outstanding issue remaining was the Living Organ Donor Bill of Rights, authored by Mrs. Boone’s group. Mrs. Boone gave an update on the Living Donor Bill of Rights and expressed the desire for it to be placed in the hands of all potential living donors. She and other advocates would like ACOT to recommend that the Secretary endorse this document and communicate the expectation that centers should give it to all potential donors.
From the floor, Donna Luebke from the Living Organ Donor Advocate Program added that advocates are open to this being a work in progress if there are things to add. Only two States (New York and North Carolina) have protections for living donors and it is not right to have a higher standard of care in one State vs. another. She stated that donors are patients and should be considered as such. Ms. Luebke stressed that there were living donor advocate groups independent of the transplant community and that advocates do not want the Bill of Rights to be taken over by OPTN. ACOT’s feedback was valued due to its status as an independent body.
Ms. Mary Kelleher, a member of the workgroup, said there was a lot of passion in the Bill of Rights and the work the advocates have done was incredible. The workgroup was not ready to make a recommendation yet, however. She and Dr. Conti both encouraged advocates to take advantage of the OPTN Living Donor Committee.
Ms. Principe asked about the process to take this further. Mr. Aronoff suggested the workgroup could meet and refine the document to their satisfaction. Then, if the workgroup so desired, a special meeting via conference call could be arranged. This requires a notice in the Federal Register announcing the ACOT conference call. Holding a vote then could occur during that call. Alternatively, members could wait until May 2009 and consider the document at ACOT’s next meeting. This would necessitate the nine new members getting and reading the final document in advance. Ms. Agrawal noted that her sense was that the document had not been completely vetted yet such that the ACOT members could vote on it. She suggested that the workgroup had to get it into final shape and decide if it should be presented to the full ACOT. She added that, in the Federal Government, “bill of rights” has a very specific meaning and a different title might be needed. Mr. Aronoff said that staff will arrange a workgroup meeting and Federal Register notice. The workgroup meeting or call should include Ms. Levine.
Reducing Pediatric Deaths on the Waiting List, Ms. Mary Kelleher
Ms. Kelleher reported for Dr. Jorge Reyes, the workgroup chairman. The workgroup held several conference calls during which it discussed Medical Examiners’ (ME) denials of pediatric transplants. The largest number of deaths on the wait list was pediatric patients waiting for hearts; many were being lost because MEs refused to release potential hearts (this happens when the potential donor was a child abuse victim and the MEs keep the hearts for evidence). ACOT committee members believed that this was not necessary; and the workgroup will continue to monitor this. The workgroup also proposed a recommendation and shared it with the full Committee. Mr. Aronoff suggested the same action as that agreed on for the previous recommendation: staff would arrange a meeting, send the language to everyone, and then discuss and vote on it during the scheduled conference call.
Funding Sources for Additional Data Collection, Mr. Remy Aronoff
Mr. Aronoff reported for Dr. Russell Wiesner, the workgroup chairman. The workgroup held one conference call on funding sources for additional data. Dr. Wiesner suggested that a small group of decision-makers (e.g., NIH, HRSA, SRTR, OPTN) hold a meeting to discuss this.
Final Report on the Economic Impact of Transplantation; Dr. Mark Schnitzler, St. Louis University Center for Outcomes Research, Director
Dr. Schnitzler described kidney transplant’s cost savings to illustrate the economic value of transplantation. From CMS’ financial perspective, Medicare breaks even within four years with a living donor, and within 6.5 years with a deceased donor. The cost savings of transplantation vs. dialysis were clear for CMS. For private insurance providers, the slope of long-term costs was lower, and the provider breaks even faster than CMS because dialysis was more expensive for those companies. Data from BCBS Missouri, linked with data from OPTN, indicate that having more organs shortens patients’ waits and significantly reduces costs. This was true for heart and lungs. At least for BCBS of Missouri, expanding the organ supply created cost savings.
Dr. Schnitzler described the “USRDS” which took OPTN registry data for 1987—2007 and linked them with Medicare data and health care claims for 2000—2007 from a large, multi-state private payer (the payer covers 29 States). Many live donor records were identified and matched. Preliminary results for liver transplantation indicate that MELD score was not highly linked with length of stay, but did predict post-transplant ICU days. The MELD scores seemed to work and patients were reaching equality in terms of health care needs after transplant.
Dr. Schnitzler assessed donor effects on center costs, noting that ECD, DCD, and ECD-DCD organs accounted for a significant growth in transplant volume. In terms of the impact of the MELD donor risk index (DRI) on length of stay, low DRI cases were inexpensive and transplants became more expensive as the DRI increased. Yet, centers receive the same amount, despite the fact that a higher DRI was financially more difficult. Dr. Schnitzler described the increased costs from higher DRI and from DCD.
Dr. Schnitzler described other uses of administrative data: the study found 667 living kidney donors and examined their rates of chronic kidney disease (the donors had higher rates as they age). Living kidney donor co-morbidities were compared to matched controls and the results indicated that, as renal function declines, the controls look worse than the donors do. This may be because donors were screened and were very healthy individuals, and therefore developed fewer problems. Disease predictors following kidney donation included age of donation, being African American or Asian, being male, and the length of time since the donation. For diabetes: 2.4% of women donors have diabetes five years post-donation, but the rate is 14% for a 50-year-old African American male (his rate for developing diabetes 10 years out is 28%).
Conclusions are that the kidney economic data allowed discussions of living donor compensation, assessment of pump and other technologies, exploration of ECD/DCD financial implications, and examination of the cost of complications. Other organs lag behind kidneys in these assessments, however. Evidence was beginning to accumulate for livers, but less so for hearts. Limitations of the study included its restriction to one private payer and the lack of charge data. The latter problem raised the question of “whose costs are being examined.” Dr Schnitzler stated that they were not really costs borne by the payer, provider, society or government. Another problem was the small sample size and need for more data. Overcoming these challenges required obtaining switch data and access to provider cost accounting. Dr Schnitzler described potential sources for data and challenges in getting them. He also described the problems inherent in paying for such studies and the need for clarification on what entity would coordinate further studies, both of which are critical to answer the questions of whether expanding the organ supply was cost-saving, and what the appropriate investment was in any such expansion.
Ms. Principe asked if VAD’s impact on heart transplant had been assessed. The response was that there were not enough data to do that. She asked how the study’s use of patients’ Social Security numbers complied with HIPAA, and was told that the study had IRB-approval for a waiver from obtaining patient consent. The researchers were required to protect the data and destroy the Social Security numbers. Whenever the researchers publish a paper, OPTN had to review it to ensure that no confidential information was revealed. There were many safeguards.
Mr. Holtzman asked if the conclusion was that the ECD kidneys are too costly to use. His center stopped recovering ECD kidneys over age 70 because the organs were not being used. The response was that there were cost savings; there are no kidneys for which there are no cost-savings.
Summing Up 2001-2008 & Long-range Areas of Interest for ACOT; Mr. Remy Aronoff and Ms. Gail Agrawal, ACOT
Mr. Aronoff thanked the members who are leaving, including Ms. Agrawal, who has been with ACOT since its first meeting. He noted that she has brought stamina, intelligence, and good cheer to the group and that it had been a pleasure to work with her. Ms. Agrawal said that thinking about the ACOT’s accomplishments had been very helpful and will guide the orientation of new members. She said that advisory committees could be reactive or proactive. ACOT was established to be reactive, but became more proactive. The group had done a good job and brought many issues forward, some of which were acted on while others were not.
Ms. Agrawal said that a nice item of business as her wrap-up would be to leave “a trail of breadcrumbs for the new members” and think of useful agenda topics. Suggestions included:
Richard Durbin thanked Ms. Agrawal for her service and expressed his pleasure in working with her for the last 9 years. Mr. Aronoff announced that Dr. Velma Scantlebury has agreed to serve in the position of ACOT Chair, pending approval from the HHS Secretary.
Discussion of Workgroup Recommendations
Reimbursement & the Changing Nature of the Donor Pool; Mr. Tom Mone, Executive Director, One Legacy
Mr. Mone’s organization, OneLegacy, serves Southern California’s 20 million people and averages 400 donors and 1,250 organs transplanted per year. Mr. Mone spoke about the effects of the expansion of definitions of viable organ donors and organs on the costs of organ recovery and transplantation; specifically, whether marginal donors adversely impacted OPOs’ ability to recover organs economically and viably. The presentation was informed by conversations with numerous OPO colleagues; participation in annual Standard Acquisition Charge (SAC) changes; and engagement in national meetings on transplantation’s costs, most recently the Lewin group meeting held in Washington in August 2008.
Deceased donor organ costs have risen in both real terms and as compared to the Medical CPI over the past 6 years. Mr. Mone illustrated this with kidney fees, which have risen an average of 35% since 2002. This was 5.5 percentage points faster than the Medical CPI, which rose 29.5% in that period. On an annual basis, this meant that kidney fees rose 1% faster than the Medical CPI. Several questions were raised, including whether expansion of the donor pool to include more ECD and DCD donors caused this increase; how cost increases due to ECD and DCD donors affect the economics of transplantation; and if there were reimbursement consequences that adversely affect OPOs, Certified Transplant Centers (CTC) and recipients.
OPOs vary enormously across the country in terms of the populations and geographic areas served and the potential for donation also varies tremendously. Most OPOs provide services beyond organ recovery (e.g., tissue recovery, processing, and distribution). All OPOs develop donation, respond to referrals, assist families, ensure donor testing, manage donors to improve organ function, place organs per UNOS lists, and coordinate surgical recovery. OPOs’ services vary, and their costs vary accordingly.
Mr. Mone stated that, despite this variation, reimbursement methodologies are straightforward. OPOs are paid a fee (Standard Acquisition Charge: SAC) by a transplant center for work associated with the recovery of each organ provided to that center. Financially, OPOs resemble suppliers (e.g., orthopedic or cardiac device distributors). OPOs are not “paid” by Medicare. CMS treats OPOs as a hybrid and requires an annual cost report from each OPO that isolates the kidney portion of the OPO’s work and ensures that no profit or loss is made on kidney recovery. Some OPOs pay CMS for any excess receipts from kidney transplant centers; for others, CMS offsets losses resulting from a kidney SAC fee that was lower than recovery cost. Usually, this variance is less than 5-10% of total kidney costs.
Mr. Mone noted that CMS has no financial jurisdiction on other organs. Net proceeds are kept by the OPO to fund growth and operations. CMS and its fiscal intermediaries have been inconsistently applying outdated rules to the situation, causing problems for OPOs. CMS needs to clarify the OPO cost report instructions or consider them as providers rather than hybrids. Mr. Mone suggested that the ACOT could consider the issue of OPO cost report instructions. OPOs are free to set SAC fees at levels that cover the cost of recovery. The only limiting factor has been resistance by transplant centers with varying degrees of representation on OPO Boards. CMS recent OPO regulations and pending guidelines on OPO Governing Boards are intended to improve this situation.
Mr. Mone discussed how much expansion of the donor pool has affected CTCs. He explored the financial impact of ECD and DCD donors versus SCD and noted that the average hospital costs of an ECD and SCD donor are virtually identical. DCD and ECD yield lower numbers of organs transplanted, so the costs per organ are higher. These costs and variations are not transferred to the transplant center because the SAC is set based on average organ cost regardless of the number or quality of the organs recovered.
What was at issue in expanding the donor pool is the spread between the SAC and the actual costs of recovering a SCD. The fact that SAC fees are rising 1% faster than Medical CPI pressures CTCs to negotiate with insurers to ensure reimbursement costs which are largely out of their control.
Mr. Mone described the impact of the 2003 establishment of the Breakthrough Collaborative and its promotion of “Every Donor, Every Organ, Every Time.” This generated an increase in the number of potential organ donor referrals from hospitals, an increase in OPO investment in Hospital Development and Procurement Coordinator staff, increased specialization and staffing to improve consent rates, and increased expenses to make donation a part of end-of-life care. While the number of deceased donors increased 31% and transplants from deceased donors increased 21%, the average kidney SAC fee has risen just 5.5% faster than the Medical CPI of 29.5%. As noted, the costs to patients and insurers are lower with transplant than with dialysis. Increased donations have yielded millions of dollars in savings from maintenance costs, and been a huge benefit to the Nation.
Ms. Principe asked if it was appropriate that OPOs did not standardize what was incorporated into their SAC fees. Mr. Mone said that it was hard to compare them and any attempt to standardize practice would be hard. It might be more feasible to disclose what was in the SAC and the SAC’s components. The impact of the variation was that, when an organ changes DSAs, cost structures varied.
Ms. Principe asked about OPOs being paid a flat rate, regardless of what they spend. Mr. Mone said that, historically, OPOs paid the hospital charges and the relationship between real and billed costs was lost. In Southern California, the average hospital cost was 50 times the real costs. His organization had negotiated flat rates with hospitals for ICU, surgery, and angiograms which increased flexibility. Looking at large numbers of donors, hospitals find his organization a better payer than BCBS.
Mr. Frieson asked if OPOs feel that ECD/DCD donors are a financial burden (looking at organ quality, patient age, donor’s medical history). The response was that, for ECD, OPOs see them as part of the culture. It was money well-spent and the price of saving lives. For DCD, without a doubt, as OPOs ramped up their programs, there were many false starts, patients that did not get recovered, time spent in the OR. Staff would be there anyway, however, since they were on-site.
Dr. Scantlebury asked about the idea of transporting the donor patient. The response was that there were three OPOs that do it, and more are starting to. In Southern California, traffic was a big issue. Benefits include reducing OPO costs, improving donor management, and freeing up an ICU bed at the donor hospitals. But, it was very scary to figure out how to do it well. Mr. Frieson added that it also gave OPOs more control over timing of recovery, and enabled them to schedule the OR with reliability.
Mr. Holtzman said that OPOs spend a lot of money to find the donor and asked for thoughts about “presumed consent.” Mr. Mone agreed and said that he had not provided much detail about those costs. Presumed consent was a hot-button topic around the world. The British Parliament voted down presumed consent, and the Korean and Australian Ministers of Health were both considering it. While it seemed to be a silver bullet, no country with presumed consent had higher donation rates than the United States. Spain still relied upon the families’ views even more than the donor’s wishes. Austria had a presumed consent law and its rates match the U.S., but it is a very homogenous country with a largely Catholic population (Catholic donation rates are very high).
Projected Growth in End-Stage Renal Disease & Implications for Future Demand for Kidney Transplants; Dr. Joseph Vassalotti, Chief Medical Officer, National Kidney Foundation (NKF)
Dr. Vassalotti described the mission of the NKF and went over the current incidence and prevalence of end stage renal disease (ESRD). Rates have continued to climb from 1996 to 2006 although the rate of increase has slowed. The growth and prevalence of ESRD was primarily among those aged 45 and older. Dr. Vassalotti illustrated trends in projected growth of ESRD through 2020 and the associated future expenditures and noted that, from a nephrology perspective, there was unfortunate job security.
According to Dr. Vassalotti, the public thinks that kidney disease is defined by dialysis, but this is false. Most patients have earlier stages of the disease and are not yet on dialysis. Dr. Vassalotti discussed kidney disease as a problem that required a public health action plan for the following reasons: the chronic kidney disease (CKD) burden is high and is unfairly distributed, upstream measures can reduce the burden, and preventive strategies are not yet in place.
Dr. Vassalotti discussed disease burden within the CKD population, and noted that cardiovascular disease (CVD) is highest in the CKD population as are risk factors for CVD and mortality. CVD risk factor control was lowest in the CKD population. Thus, targeting CKD was a rational approach to slowing patients’ progression to ESRD and preventing CVD events and death. National Health and Nutrition Examination Survey (NHANES) data have indicated an increased prevalence of risk factors with increased CKD stages.
Targeting CKD makes sense for several reasons, including that early intervention can make a difference. Dr. Vassalotti noted that the CVD burden in the general population was located primarily in those with CKD. While the absolute size of the CVD population was largest in the non-CKD population, adverse event rates were highest in the CKD population and generated large health care costs. Targeting the CKD population of those with diabetes and hypertension could provide the highest yield for detection, treatment, and control of the disease. NKF has two early detection programs to reduce ESRD: the Kidney Early Evaluation Program (KEEP) and CKD Health Examination Risk Information Sharing (CHERISH).
Dr. Vassalotti described KEEP as a free kidney health screening program designed to raise awareness about CKD among high-risk individuals and provide free testing and educational information. Targets include individuals with diabetes and hypertension, and with a family history of diabetes, hypertension, or CKD. Over 120,000 patients have been screened. The six-station screening includes a health questionnaire and screening; with the person’s permission, the results are also sent to their health care provider. KEEP usually occurs in non-medical facilities, such as faith-based organizations and community centers. Follow-up is stressed and referrals made. Dr. Vassalotti described how KEEP differs from other programs, reported on the data from its first 10 years, and described new activities implemented in 2008. For example, KEEP started a longitudinal program to look at changes in risk factor control and medications, added BMI measures, and increased the number of publications and talks.
Dr. Vassalotti described CHERISH as a State-level CKD pilot program based on the KEEP model. The goal was to create a simple, clear, and easily implemented program. The four pilot States (California, Florida, Minnesota, New York) were selected because they contain 5% of the Medicare sample of CKD and large minority populations. To date, about 300 people have been screened. CHERISH uses self-reported criteria to identify risk factors and has harmonized its questionnaire with the NHANES questionnaire. Follow-up occurs by telephone at 3 and 12 months. Dr. Vassalotti summarized the CHERISH program’s design principles.
Dr. Scantlebury asked about KEEP’s community partners and program funding. The response was that community partners included religious organizations, community centers, community health centers, and other places where people congregate. KEEP was supported by about 10 industry-sponsors that provided funds or in-kind support. CHERISH was funded by the CDC.
Dr. Leffell said she was delighted the NKF is targeting the Native American population through the Minnesota pilot, since this population had higher rates of type 2 diabetes than other groups. Dr. Vassalotti responded that the programs also have a high prevalence of Hispanic and African American participants but have not been as successful in reaching Asian/Pacific Islanders or Native Americans. Some areas had better representation from these groups. The NKF will expand outreach efforts and CHERISH was one attempt to reach more minority populations.
Dr. Scantlebury asked how the NKF decided where to implement programs and if any areas lacked programming. The response was that the NKF attempts to cover the whole country. Data collection efforts are both centralized and national and include strong privacy protections, e.g., the QI program addresses safety.
Dr. Conti expressed dismay that there will be a greater need for organs but there will be fewer possible donors because of higher rates of medical problems which will preclude individuals from donating. He asked if the country should be doing more, generally, to prevent diabetes, hypertension, and CVD. The response was that the U.S. spends more money and efforts on secondary prevention and tertiary treatment than it does on primary prevention as a whole. The problem was societal and there will be difficult times ahead. Dr. Vassalotti stated that challenges are opportunities.
Briefing on OPTN White Paper on Charges for Pancreata Recovered for Islet Transplantation; Dr. Joseph Keith Melancon, Director of the Kidney and Pancreas Transplantation Program, Georgetown University School of Medicine
Dr. Melancon’s talk provided a primer on pancreas and islet transplantation and the White Paper. He stated that diabetes (particularly type 1) was uniquely situated for cellular or regenerative therapy. An ideal cure for type 1 diabetes required a device (e.g., tissue, cells, organ) capable of performing the two essential functions of the missing Beta cells (sensing blood glucose levels and secreting appropriate levels of insulin to the blood stream).
Dr. Melancon stated that the goals of pancreas and islet transplantation are low morbidity and/or mortality, elimination of the need for insulin therapy, elimination of hypoglycemic events, creation of an euglycemic state, and sustained glucose homeostasis. The Edmonton Protocol of 2000 was a very exciting and important advance that showed allogeneic human islets can be safely grafted to diabetic patients and that islet grafts can survive and normalize glucose homeostasis for several years. Dr. Melancon expressed the view that a cure for diabetes was within reach, given a sufficient supply of islets or beta cells. A key element of success was transplantation of high-quality purified islets in sufficient numbers. The international trial of the Edmonton Protocol had good, but sobering, outcomes and results were not as good as with solid organ pancreas transplantation.
The White Paper on financial issues constraining islet transplantation was published in American Journal of Transplantation in April 2008. It argued for continued clinical investigation of islet transplantation and lamented that clinical islet transplantation was severely limited by complex financial accounting issues that unduly burden OPOs and transplant centers venturing into the field. As background, in 2004, 10 societies that broadly represented the transplantation field sent a joint letter to CMS that expressed concerns about payment for pancreatic islet transplantation. In 2006, CMS ruled that a full standard acquisition fee was to be collected for recovered pancreata regarding “intent to transplant” (CMS-1543-R Dec 21 2006). This was problematic because, unlike with solid organs, it is not known if the pancreas will yield good materials until the isolation has been performed. Twice as many procedures were required for the procedure and a SAC must be paid for all of them, which doubles costs. Entities not part of the NIH Collaborative needed private funding for this.
Dr. Melancon said that, currently, over 60% of available pancreata were not recovered for transplantation. HRSA identified pancreas and islet transplantation as central to its mission of increasing the number of organs transplanted per donor. Yet, the cost of pancreata for islet transplantation was a negative stimulus for pancreas organ utilization in the U.S. Additionally, Dr. Melancon stated there was no way to determine in advance if a procured pancreas would yield islets appropriate for transplantation. On the one hand, more experienced investigation was needed to improve outcomes and increase recovery and utilization of available pancreata. On the other hand, current financial rules complicate use of available pancreata and conflict with missions of key stakeholders in islet transplantation (CMS, NIH, HRSA, FDA, AOPO, UNOS, Juvenile Diabetes Research Foundation).
Dr. Melancon stressed the need to clarify CMS’ final rule’s language by taking into account the suitability for transplantation of the final islet product following the islet manufacturing process. He also suggested that pancreata allocated for islet transplantation that do not yield a final islet preparation suitable for clinical transplant could be treated for cost accounting purposes as tissue, so as to allow for the lesser charge for the pancreas. Recent studies from the University of Minnesota have documented improving outcomes after isolated islet transplantation with novel immunosuppressive strategies. Islet transplantation seemed to be uniquely suited for xenotransplantation. But, more investigations into ways to decrease immune responsiveness to alloislets were needed to shed light on islet autoimmunity of type 1 diabetes. Finally, decreasing financial disincentives of islet transplantation would allow better utilization of deceased donor pancreata.
Dr. Conti said that Edmonton’s disappointing long-term results resulted from isolation or the need for better immunosuppression, and he asked if there was the risk of sensitizing people who might need a kidney or pancreas later on. The response was affirmative. Edmonton showed that high-quality isolated islets are key. The ultimate problem was that the immunosuppression was not good enough. Dr. Melancon expressed the view that different immunosuppressions are needed.
Dr. Leffell noted that another major reason to pursue islet is to increase understanding of the pathogenesis of diabetes. She asked why only half of pancreases yield enough islets for transplantation, but the solid organs would function if they had been transplanted. Dr. Melancon stated that he believed the isolation techniques were somewhat to blame. Auto-islet experience has shown that one can take the patient’s pancreas out and give the person back his or her own islets with excellent outcomes. The immune response was working there. There was something about the islets that makes them happy where they are, inside the pancreas. Auto-islet data indicate they can be happy in the liver too, and not have immune responsiveness.
Ms. Kelleher asked for clarification about the White Paper’s support for methods to overcome the financial constraints. The suggestion was to not give whole organs to research, but rather to lessen the costs for using organs that would otherwise be discarded. Dr. Melancon agreed. The idea was not to take ideal pancreata and use them for research but, when they are designated for islets, the financial burden should be reduced to further research.
Dr. Scantlebury asked, in terms of decreasing the costs of using islets, if there had been any discussion with OPOs about the costs if the pancreas was or was not removed along with the liver and kidney. In other words, did it cost the OPO more if the pancreas came out or not. The answer was that the OPOs tend to worry about the ambiguity of the CMS regulations. The chair of the OPTN Pancreas Committee thinks there is a movement among OPOs that want to give more pancreata to centers for islet transplants but fear they would not be protected if they fail to charge the full SAC fee. Mr. Holtzman concurred that his facility had reduced rates for islets for researchers before 2006, but CMS now required it to allocate full costs if the organ was recovered for either solid organ or islet transplantation. There was $15,000-20,000 to recover but researchers only wanted to pay $2,000-$3,000 per organ. He stated that the Government could and should change this. Ms. Agrawal commented that staff were taking notes and got the point.
Jim Warren, editor of Transplant News, spoke from the floor and asked about recent advances in the development of the artificial pancreas. Dr. Melancon said that one problem was the need to sense when hypoglycemia was occurring and how much insulin was needed. While good sensors did not yet exist, the technology should be pursued. The long-term morbidity was associated with hyperglycemia, but hypoglycemia was behind many other problems and patients know it. They know that taking more insulin makes them feel terrible. The pancreas, islets, and beta cells do things that are not yet fully understood and the solution would be more than just giving insulin.
The Executive Director of the American Society of Transplant Surgeons spoke from the floor. She noted that a large collaborative effort was exploring these issues and a meeting was scheduled for December 10 with Dr. Barry Straub at CMS. She appealed to the ACOT to bring the meeting to the Secretary’s attention because an interagency meeting was needed and could only be called by the Secretary. She added that the ruling on “intent to transplant” should be undone immediately and doing so would be easy. It would be very helpful if the ACOT could suggest that CMS include other agencies (e.g., NIH, HRSA) at the meeting.
Ms. Agrawal noted that, at this time, the Committee lacked a formal recommendation to consider on this topic. Mr. Aronoff said that a workgroup could be formed on this issue but that a recommendation could not be finalized before the May 2009 meeting. He asked any ACOT members who wanted to be on such a workgroup to let him know. Ms. Agrawal noted that, while it was not possible to take a formal vote yet, she observed a lot of interest from ACOT members, indicating support.
Ms. Donna Luebke from the Living Organ Donor Advocate Program announced that she had confirmation that Medicare will pay for donor complications, even if the secondary and primary refused, and will pay for complications from surgery years out. She noted that was variability in insurance plans and how they covered complications and for how long. The New York Department of Insurance has released information for insurers about what services and coverage could be refused and it was clear that insurance companies can refuse to cover a donor. While they cannot cancel insurance, they can raise costs. This information was released in July 2008. She noted that, if donors are to be fully informed, the field needs to get a handle on this. Coverage specifications vary greatly and donors should not be getting bills for their complications.
The meeting was adjourned. The next ACOT meeting will be held in May 2009.