Prior to the meeting, newly appointed ACOT members were sworn in as members of the Committee in a private ceremony.
Thom Balbier, Executive Director, ACOT
Mr. Balbier welcomed the group to the Washington area, and noted the meeting would start after a short video presentation on ethics training, which is required for certain Federal employees and Special Government Employees (SGEs). Ms. Jennifer Jordan, who had been scheduled to present this session, was unable to attend the ACOT meeting.
The video covered ethical requirements for government consultants, such as grant reviewers, advisory committee members, and other SGEs. The video addressed how to assess conflicts of interest, and described conflicts that might occur around financial holdings of SGEs and their family members; acceptance of gifts; and activities such as teaching, speaking and writing. Mr. Balbier noted that ACOT members are asked to serve because of their experience in organ donation and transplantation and, as a general rule, the Committee has waivers approved for all Committee members around their particular area of expertise. Members only have to do the financial paperwork once, unless there is a major change in assets or employment. After the video, Mr. Balbier introduced Dr. Hans Sollinger as the new chair of ACOT.
Hans Sollinger, Chair, AC
Dr. Sollinger thanked Mr. Balbier and expressed his appreciation for all of the ACOT members (especially the mothers) who left their families on Mother's Day in order to attend the meeting.
Dr. Sollinger welcomed the new members and noted the handout providing information about the new members and their backgrounds. Dr. Sollinger reminded the group that ACOT was formed in the last year of Secretary Shalala's administration, and it met for the first time under Secretary Thompson. ACOT has accomplished a lot over the last four years — it has issued proposals and recommendations that have had an enormous impact on U.S. organ donation. Due to the Breakthrough Collaborative, there has been an 11 percent increase in organ donation in the U.S. Overall, it has been a very successful and productive four years. Dr. Sollinger noted that, in his first meeting with former Secretary Thompson, he had suggested that it was important to focus on increasing donations (rather than addressing allocation issues). He said he felt real progress has been made in this area.
Thom Balbier, Executive Director, ACOT
Mr. Balbier updated the group on ACOT activities and reviewed the meeting agenda. A notice of this meeting was published April 11 in theFederal Register and included the notice that there would be an opportunity reserved for public comments over the next two days. He asked the group, when discussing future agenda items, to think about the subcommittees that exist, and consider what subcommittees might be established in the future, or whether ACOT should have informal arrangements like workgroups formed to consider special initiatives or projects. He noted the success of the recently formed Workgroup on CMS Regulations as an example.
New members should remember that service on ACOT is based on an individual's experience. However, when voting, members should consider the broad public policy interests, rather than the interests of any particular organization with which they may be affiliated. The ACOT, located on the Organ Donor website now lists the expiration dates of all members' terms. Mr. Balbier noted that several members' terms expire in July, and asked those members to keep the November 3-4 meeting dates on their calendars because each ACOT member's term continues until his or her replacement is named. New appointments for ACOT were solicited by publication on March 4 in the Federal Register. There have been 64 nominations received, but Mr. Balbier said that the appointments process can be lengthy, and may not be completed in time for new members to attend the November meeting.
He finished by stating that the Uniform Anatomical Gift Act (UAGA) is close to 20 years old and there have been many changes in the field since the UAGA was first crafted by the National Conference of Commissioners on Uniform State Laws (NCCUSL). Proposed amendments to the UAGA have been developed and are currently being circulated for review within the NCCUSL Drafting Committee on Amending the UAGA. HRSA staff has been participating as observers with the Drafting Committee, which will report its first draft of an amended UAGA to the NCCUSL at its annual conference this July.
Frank Delmonico, Medical Director, New England Organ Bank
Dr. Delmonico presented on the National Conference on Donation after Cardiac Death (DCD), which occurred in April 2005 with the participation of many groups, including WHO, AMA, AOPO, JCAHO, ASA, CCN, SCCM, and AST. He noted that the IOM has issued a statement that DCD is an ethically proper approach to recovering organs. The conference goal was to expand this practice particularly with respect to quality end-of-life care. He said that when life support is withdrawn, especially in an ICU, there should be an opportunity for DCD so that families can honor the deceased. The message that the conference wishes to stress is to convey the social responsibility of DCD and the appropriateness of determining death using circulatory or brain criteria.
The conference consisted of six working groups on:
Dr. Delmonico explained the findings, to date, of these workgroups. He noted that DCD is increasing, but there are places where none has occurred to date. Some OPOs and Donor Service Areas (DSA) lack experience in this area and the group's objective is to work with those areas to improve their experience and start DCD policies and practice. It is important to get information about this to the public and the media, so more people know about it and know that DCD saves lives.
Dr. Delmonico said that the group wanted ACOT to endorse the recommendations, support development of research studies, and also to revisit Recommendation 14 (require hospitals as a condition of participation, to establish DCD programs and policies). Also, ACOT is asked to:
Dr. Sollinger thanked Dr. Delmonico for the presentation and for being such an eloquent spokesperson in this area. He said that it's known that organs function well if the donor is picked carefully and it's a major concern that so many OPOs do not have DCD as a component of organ donation. As a result, many donations are lost. In Dr. Sollinger's region, they had to spend a lot of time traveling to donor hospitals to talk to boards before the hospitals would add DCD protocols; but still, some of the larger hospitals lack policies. He agreed that having DCD policies should be a condition of participation with CMS. Dr. Delmonico said that DCD has the support of the community and JCAHO is very supportive. By every method of reviewing practice, it's clear that DCD should be a component of organ donation.
Mike Seely asked if the OPTN membership criteria have been fast-tracked.
Dr. Delmonico responded that there will be a strategic plan for OPTN in the fall and the goal is to include this. The OPOs should have a policy and protocol for DCD. Mr. Seely asked if, with respect to the 15,000 discards mentioned in the presentation, there were any data on biopsies or cull time as discard factors. Dr. Delmonico said that currently a HRSA grant is looking at this question. In some cases, biopsy is a factor, but there is a need for more data. There are people who are on dialysis who could benefit from these organs. Even if the function is not excellent, it's better than being on dialysis for these patients.
Dr. Kahan said that in Madrid (Spain) they have on-site preparation by the emergency team and have had good results. In the field, one often finds better organs.
Dr. Delmonico agreed that the Spanish are ahead of us in this area.
Dr. Young said that he found the same problem in Alabama. They had to go to the ethics committee several times to show them the data to get DCD approved. Because of the fear of litigation, it is very hard to get hospitals on board. He said that, if CMS had a regulation to make DCD a standard of care, it would help. He suggested better education of medical providers so they are on board as well. In many cases, the medical providers have no idea about the benefits of DCD.
Susan Gunderson said that she was looking forward to seeing these results. As an OPO that implemented DCD the week before, she confirms that the process takes a long time. Having the IOM report behind us has been really helpful, and this new report will really help as well. Making DCD a CMS condition of participation for donor hospitals will be beneficial. She asked if there were any deliberations around ethics for caregivers and the timing — this has been a thorny issue — in terms of whether the caregiver doctor is also the one who wants to pursue DCD.
Dr. Delmonico said there has to be a progression. It has to be established that it is futile for treatment to be given. People have to trust the doctors not to be overly pursing the goal of organ donation. He stressed that the end of life care is the main priority and this has to be paramount for everyone concerned. When that is established, then the continuum goes to the next phase, which happens after it's not feasible to continue treatment. He asked ACOT members to please make comments when they see the report.
Dr. Migliori said that the delayed function requiring dialysis is striking and leads to higher costs. He noted that reimbursement requirements will have to be adjusted. He said given that the discard rates are unacceptable, is the fear of the cost burden adding to discards? Dr. Delmonico said this was absolutely the case. There is a question of whether, when a donor is declared dead, there is a way to improve the organ function. The University of Michigan is a leader in this, and there is the possibility that organ functioning could be improved by resuming oxygenation.
Dr. Sollinger said that one way to do this is to keep ischemia time as short as possible. They are handling kidneys like they are hearts in his hospital. They know up-front and the recipient comes in and is ready to go — they are down to 4-5 hours. Dr. Delmonico responded that, right now, it's hard to consider allocation protocols that give preference acceptance and that ACOT might wish to address this.
Ms. Turrisi said that ACOT has looked at adjusted versus unadjusted data and one issue that has come up is that there is a difference in outcomes (especially for livers) around informed consent. She said it was desirable that ACOT recommendations include support for the DCD conference findings. Dr. Delmonico agreed that not all donors are the same. At the final phase, where the surgeon decides, they have to decide about the risk of failure. Profiling of the donor should have been discussed with the patient and family.
Dr. Evans suggested that one should look at resource utilization (e.g., hospital days) and do this early on as part of data collection and tracking major resources that are used to see how they fluctuate. Each individual institution can do that internally. This can be part of the protocol to work with SRTR and the data collection could start right now. Dr. Delmonico said it would be helpful to the OPTN to have this as a recommendation from ACOT that this can be put in their strategic plan discussion. It's sophisticated and practical.
Dr. Evans continued that discharge data are already collected and there are few standard donors any more. There is a continuum of risk for all donors that have to be discussed with the patients ahead of time. We should recommend what kind of informed consent should be carried out (without being so specific) and saying what should be done. With DCD, these conversations have to happen well before the transplant occurs. We should get away from DCD informed consent versus other kinds of informed consent — we should talk, rather, about what the risks are overall.
Ms. Turrisi agreed, but said there has to be documentation of some sort that outlines what kind of consent and information has been given to the patient and the families. She said she didn't think we are always consistent in how and what we do for patients and families. Her feeling is that informed consent is critical — patients have a right to know and to choose. Giving the elements of informed consent and guidelines on the process for providers is important. The framework on paper is important because there are many people who do it and their abilities vary widely. The informed consent form should be a guideline and not the be-all and end-all. Dr. Evans agreed, but felt this should not be a Federal guideline.
Dennis Wagner, Social Marketing Leader, DoT, HRSA
Virginia McBride, Public Health Analyst, DoT, HRSA
Jade Perdue, Public Health Analyst, DoT, HRSA
Virginia McBride updated ACOT on what has happened since the last meeting. The purpose of the Collaborative is "saving or enhancing thousands of lives a year by spreading known best practices to the Nation's largest hospitals, to achieve organ donation rates of 75% or higher in these hospitals."
Among the goals of the Collaborative are to increase the annual number of deceased donor organs transplanted by 100 percent; to increase non-cardiac death donors by 333 annually; and to increase annual cardiac death donors by 175 annually. The collaborative is on-track to meet these goals.
Ms. Perdue reported on the Collaborative process, a deliberative process that generates learning periods and tests changes in order to achieve a goal. To date, the Collaborative has identified best practices, held a National Learning Congress, and begun working with two teams of hospitals on changing their practices. The first round ended in September 2004 (95 hospitals and 43 OPOs); the second round included 131 hospitals and 50 OPOs. With the third round, the Collaborative's participating hospitals now account for 50 percent of all eligible donors in the United States.
Ms. Perdue ended her presentation by asking Ms. Gunderson and Mr. Seely to talk about what has been the biggest benefit to the OPO or hospital from participating, and what is the best idea to spread to hospitals. Ms. Gunderson reported that the Collaborative has become a machine, it has energy and momentum. The biggest benefit is that everyone is on the same team now — the OPO, donor hospital, and the transplant center. Also, the Collaborative has brought new tools and thinking into this work.
Mike Seely reported that the key thing is the redefining of relationships that propel us forward, breaking down barriers, spreading hospital ownership of the process (so they are engaged). There is more real-time discussion of events now; huddles happen quickly, which keeps it at the forefront of people's minds. We all own it together.
Dr. Higgins asked if there has been any assessment of where the lowest donations rates are and if institutions from those OPOs have been asked to participate in the Collaborative. He noted that urban hospitals might benefit from these process improvements. Ms. Perdue replied that she was not certain if they have specific percentages in terms of urban hospitals. They have looked at hospitals with the largest donor potential, and these hospitals are included in the Collaborative.
Dr. Sollinger said he felt that the Collaborative's success has come from it being so positive and being presented as such a great thing to do. It is really very exciting and is very appealing to people. A lot of the credit goes to the staff of the Collaborative.
Mr. Wagner discussed the aim of the Collaborative and its sub-goals. He also showed a short video on what has been done. The video illustrated how the Collaborative has resulted in a shift in attitude to one that affirms transplantation and actively seeks donations. Mr. Wagner said that the 250 hospitals in the Collaborative are among the largest in the United States. Henry Ford, one participant, used to have a 22 percent conversion rate and now has a 75 percent conversion rate sustained over 12 months. The big ones are getting good.
The participating organizations choose among best practices to test changes that will help reach the goals. These include actions to improve timely notification of the OPO that will permit a successful donation to occur; increase donation rates; reduce medical examiner denials, etc. High leverage changes are overarching strategies that lead to 75 percent donation rates. They include advocating organ donation as the mission; involving senior leadership to get results; deploying a self-organizing OPO/hospital team; practicing early referral and rapid response; learning effective requesting; and implementing DCD. A 75 percent national conversation rate would yield 9,000 donors per year. An increase in three organs per donor to almost four organs translates into 36,000 transplant recipients. There are 88,000 people on the waiting list and 6,000 deaths on the list. Expanding donations could feasibly eliminate deaths among those on the waiting lists.
Since the Collaborative started, the number of donors across the Nation has increased to unprecedented records. The Collaborative began in October 2003. In 2004, every month exceeded the best number of donations of any previous year and set new donation records for that month. In 2005, there have been even higher numbers and we clearly have not reached the upper limits of what is possible. There were 631 donors in April 2005, which is a 15% increase over last year and is statistically significant.
Mr. Wagner concluded by recognizing Russ Hereford, from the HHS Inspector General's office, who suggested they recognize high performing hospitals. Ms. Gunderson said that getting a medal of honor has amazing results. When you tell people they will get an award it's very motivating. Her site had lower rates for lungs and has increased lung yield dramatically in just four months.
Dr. Sollinger thanked the group and said that they have done a lot of work with OPOs and hospitals. Next, the Collaborative needs to work with — and ACOT needs to help with — the surgeons. Successful surgeons are gung-ho, but there are other surgeons who need to be motivated just like the OPOs have been.
Dr. Migliori said that what has been achieved is very exciting. The timing and magnitude really demonstrates that a collaborative effort will yield results. The accomplishments here are nothing short of spectacular as the growth rates in performance would be respected and admired in any industry, public or private. The Collaborative is grinding donors through, but another issue is the discard levels at the end.
Dr. Freeman commented that the Collaborative is showing high yields in bigger hospitals, and asked what was being done to share these results with other hospitals without going to meetings and such. Mr. Wagner said that this information is in the public domain and the Collaborative also is working on a "spread strategy." This is like a practice that was originated by Ford and Nokia where one pumps changes out to leaders (in this case, in OPOs) and then track their use of practices. He said the Collaborative will track the information and see if it's getting out there. The hospitals report back if they are testing an idea, have implemented it, are not using it, or found it did not work. The knowledge management system (KMS) has a focus for pushing changes out and tracking them. They are also drafting articles for JAMA, Critical Care Nurse, book chapters, etc. The National Learning Congress will host CEOs from large hospitals who will attend a leadership track. ACOT's suggestion to engage JCAHO in the Collaborative was a good one.
Dr. Freeman said that having a higher proportion of organs coming from DCD will impact the yield. The fourth goal of 10 percent DCD may not improve the total number of organs procured. Ms. McBride clarified that the goal is to increase the numbers of DCD without a loss in gains among other donors. The concern is one that the OPOs have expressed. However, the U.S. national data do not bear out this concern (although Dutch data do).
Dr. Zhu said that he is very impressed that statistically significant improvement is being discussed. Are people looking at rate of survival and patient outcome? Ms. McBride reported that best practice among patient survival is being looked at and that this is the next direction. Dr. Zhu suggested that if you do more transplants, and have more organs, but the outcomes are not improved, it would be a problem. Dr. Sollinger said that the outcome would be that more people are alive, and that's an improvement. With kidneys, we know that when you do a transplant, people do better than when they were on dialysis. When you transplant more people, there are fewer people on dialysis, so there are fewer deaths.
Kathy Turrisi, Program Administrator, Medical University of South Carolina Transplant Center
Ms. Turrisi noted that only she and Dr. Young remain as members of this Subcommittee, whose work grew out of the Subcommittee on Expanded Criteria Donor (ECD) organs. One question has been what defines an extra-renal ECD organ. The group asked SRTR about this and would like to have this information in language that we can all understand. She did not want just primary graft function but wanted to see 1-3 year survival rates.
The question the group considered was what defines relative risk? It seems arbitrary and subject to change. When looking at the CMS guidelines, the group also wondered about expected vs. actual survival rates — and the importance of relative risk for this. What is adjusted vs. unadjusted? The issue is, when explaining things to patients, how can risk be explained in a way that is easy to follow? There is a need to be clear and consistent in our explanations. In terms of informed consent for ECD organs (livers), there is a difference in survival. Should the patient know this first? This is part of the informed consent issue. As we become more public about outcomes, there needs to be a better understanding and consistent interpretation of what we're being held accountable for.
The Subcommittee wanted to know if there are algorithms for doctors to use for ECD organs and with patients. The Subcommittee wanted algorithms to help inform patients and for doctors to use to decide if this is the best organ for the person at that point in time. What can we do to help everyone provide the best information to guide care? The Subcommittee asked that SRTR be invited to the ACOT meeting to provide an overview of their activities that would include an explanation of relative risk, future plans, expected vs. actual survival — all the things that create confusion.
Robert Merion, Professor of Surgery, University of Michigan; Clinical Transplant Director, SRTR
Dr. Merion talked about center-specific reporting tools that are available and mandated by law. His presentation also addressed what SRTR provides in center-specific reports. He began by differentiating SRTR from OPTN and describing the work each conducts. In short, SRTR does activities around inferential analysis and analytical data reports, some of which are mandated by NOTA (e.g., reports for policy-making committees, annual reports, OPO-specific reports, Membership and Professional Standards Committee [MPSC] reports, etc.).
The data come primarily from OPTN in a monthly transfer. SRTR does "person linking" so that one patient can be followed across multiple transplants and states for longitudinal tracking. These data are supplemented with others and then cleaned and validated to create standard analysis files that are used by biostatisticians and other analysts. Different groups have different needs and interests in the data: patients and families are interested in specific questions about what will happen to them. Payers and MPSC want to know if the centers are performing up to standards. The centers want to know what choices their patients have.
Dr. Merion then discussed risk adjustment and how this is calculated. He used adults (aged over 18) and walked the group through a comparison of survival rates for the national average and a center's expected average given its patients. When calculating expected outcomes, he noted that age matters for most organs and used age greater and less than 45 years of age as an example. Whenever expected survival is depends on a particular characteristic of the patients, the risk adjustment takes into account the varying types and characteristics of patients at a given center.
Likewise, with ECD kidney donors, the factors that affect outcome are taken into account the components of ECD characteristics for kidneys each has a relative risk or hazard ratio (donor age, history of hypertension, elevated serum creatinine, and cerebrovascular accident as the cause of death). The data show the risk of failure by these different kinds of risk.
Ms. Turrisi asked if there was an ECD classification for liver. Dr. Merion said that there is not a codified and accepted definition of ECD liver, heart and lung, so the SRTR can't use a separate flag for them, like they do for kidney. There are factors that are likely to (and do) show up and these components are in the model. DCD status is in the liver models (except for the pediatric model).
Dr. Merion noted that risk adjustment includes demographics, primary disease, donor cause of death, previous transplant, life support, dialysis, creatinine levels, etc. There is a very large pool of data to choose from. The documentation of risk adjustment models is on the website. Dr. Merion also talked about patients who are lost to follow up (LTFU) and the resulting incomplete data. Transplant centers report transplant failure and mortality, but the burdens to track long-term are high. Now that the system for reporting is web-based, the data are much better. They spend a lot of time looking for data on deaths to make sure they know about the outcomes. SRTR captures more than 99 percent of deaths.
Dr. Delmonico asked if a transplant center can have a 20 percent higher risk of graft failure, and if it's not a very large center, what does this actually translate to in terms of actual outcomes? Dr. Merion said that this fact is exactly why SRTR reports data in a lot of different ways — you can look at one or more of the outcomes and use what speaks best to you. You could choose one metric to evaluate performance, but SRTR doesn't. They use observed over-imputed values, and several criteria. There is a User Guide Text with each center's report that gives the expected rate and notes if the actual rate is from chance or from something more significant. See more information at the US Transplant - Scientific Registry of Transplant Recipients Web Site .
Centers are flagged when they have higher than expected numbers of problems. A center is referred to MPSC if it gets flagged on three criteria (more than three excess deaths, clinically significant number of deaths (observed:expected ratio >1.5), and statistical significance of the deaths). Only 7 – 10 percent of transplant centers have all three flags (this varies by organ). Dr. Freeman asked what percent are not able to be evaluated because of a lack of numbers — are there a lot of small volume centers you can't look at? Dr. Merion said he didn't know, but would follow up and report back.
Dr. Sollinger thanked Dr. Merion for the presentation, and noted that people had asked their questions during the presentation, so the group would move ahead to the next presentation.
Marcia Newton, Senior Policy Analyst, CMS, DHHS
Ms. Newton presented an overview about how a regulation comes into being and the specifics around transplant regulations. She spent most of her presentation addressing the comments that have been received so far by CMS on the proposed regulations.
On the proposed conditions for coverage, comments received included that the proposal would diminish appeal rights by eliminating two chances to be heard, since the entities would be taken out of Part 498 and have only one appeal opportunity. It would sacrifice due process in favor of speed and the CMS hearing officer could be subject to agency influence.
On the recertification and competition process, Ms. Newton noted that no one likes it. Comments include that CMS should limit competition to OPO service areas that are opened due to de-certification. Opening all areas to competition would harm relationships formed under the Collaborative; ignore regional variations in DSA culture; decrease donations due to changeover to new OPO; and shift resources from OPO core missions.
On performance measures, comments include that CMS should count all organs recovered for research toward certification; should consider using the SRTR methodology as part of outcome measures; should not apply performance measures retroactively; and should permit new entities to become OPOs.
On organ donor potential, comments include that CMS should limit the definition of potential and not include DCD and ECD; and should not count DCD in the numerators for the outcome performance measures.
On cooperation with tissue banks, this was a major source of form letters. Tissue banks wrote to say that OPO shouldn't have to cooperate with banks that do not have OPO-consistent policies. Comments also include that CMS should require OPOs to include tissue banks in any training designated.
On administrating and governing, comments included that CMS should establish requirements for OPO boards that the governing board include lay and transplant professionals, that no more than 50 percent of board members be from transplant hospitals, and that boards should include families.
On human resources, comments included that CMS should hold transplant centers, rather than OPOs, responsible for verifying recovery surgeon's credentials, and should set standardized training for OPO staff and set course content.
On the transplant coordinators certification, comments include that CMS should require the same thing for procurement coordinators, and should not establish a specific requirement for becoming an "experienced" procurement coordinator.
On information management, comments include that organizations should not have to maintain tissue and eye donations in their records.
On consent, CMS is getting a lot of letters from tissue banks. Comments include that CMS should not require OPOs to provide information about tissue donation or ensure informed consent for tissue donation; should not require OPOs to inform families of potential tissue donors that tissue banks may be "for-profit" entities.
On donor evaluation and management, she noted that the regulations do not include a lot of information on DCD and ECD because they were begun about four years ago, before the Collaborative and DCD/ECD discussions began. Comments include that CMS should require every OPO to have a DCD policy in every hospital.
On quality assurance, comments include that CMS should define "adverse event" more clearly and clarify if information on adverse events would be public information; and that CMS should require OPOs to perform death records reviews on a quarterly or monthly basis.
Ms. Newton also described the comments received on the Transplant Centers regulations. She noted that CMS is proposing transplant centers regulations in order to decrease confusion by codifying requirements for all transplant center types into one regulation. Right now, the regulations are all over the place and many rules are in coverage decisions rather than in one regulation. CMS wants to revise the current criteria to reflect improvements in the transplant outcomes and to establish a mechanism for re-approval of centers. In 1999, at a town hall meeting, CMS was encouraged to draft regulations for transplant centers because many people felt they were needed.
On procedures for re-approval, comments include that people seem to like the proposed outcome measures.
On patient and living donor selection, comments include that CMS should not limit psychosocial evaluations for prospective transplant recipients to only being conducted by clinical social workers, as patients may need further evaluation by clinical psychologists or social workers; CMS should develop and require uniform criteria for assessment of living donors.
On patient and living donor management, comments include that CMS should mandate that coordination be done by a doctor other than the one who will perform the recovery; a specialist should do the follow up for that organ; CMS should not include requirement for providing nutritional services to living donors; other comments were in support of providing nutritional services; the suggestion that CMS conform requirements for qualified dieticians with those in the 2002 CMS regulations for nutritional therapy; and support for social services being provided to recipients, donors and families by social worker.
On rights, comments support establishing uniform standards on rights.
On donor advocates, comments suggest that CMS should require centers to provide living donors with an advocate who is an RN, or a physician trained to be an advocate; and that the donor advocate should not be a member of the transplant team.
On human resources, comments include that CMS should grandfather in all transplant coordinators or all coordinators with five years of experience; should provide alternative routes for certification of coordinators; should require certification of transplant coordinators; and should require that certification be accomplished by ABTC.
On procedures for approval and re-approval, comments include that CMS should require separate approval for centers that do living donors, and should support re-approval of lung centers every three years.
On alternative approval, comments include that CMS should conduct a random survey of centers "to keep them on their toes"; should survey centers only if they do not meet the data submission and outcome requirements; and should not use OPTN feedback to determine whether a center should be surveyed — base on statistically significant data.
Mrs. Boone asked questions about informing living donors of the potential risk and securing informed consent. If there is no organization that follows living donors over the long-term, how is this information on the risks to be achieved? How can we inform them when we don't know what happens to donors over the long term?
Ms. Newton said there is a limit of the information we can give to people until we have a living donor registry. CMS used the most important things from ACOT's list of informed consent components. We would expect transplant centers to give their data to recipients and living donors.
Mr. Seely said that OPTN is starting to do this; it will begin to fall into place as the OPTN serves as a central registry. Dr. Delmonico said that the community is going to be reviewing this and that OPTN is making a very, very careful review. Documents on informed consent have been well established by ACOT. Mrs. Boone reiterated that, without long-term follow up of living donors, it will be hard to achieve true informed consent. Dr. Delmonico said that Transplantation just published a study on 50 years of live donors.
Dr. Kahan asked if there was public information on the data collected on adverse events. Ms. Newton said that CMS hasn't talked about this, but it's typically the kind of thing that would be put into a final regulation, and CMS welcomes comments on it. The intention is to give OPO coordinators an opportunity to work with the OPO to see what happened and make sure it doesn't happen again. A Medicare plan of correction is FOIA-able but there is no personal patient information in it. Dr. Kahan said that this is very important information to have in terms of rapid trace-backs.
Dr. Robert Metzger asked about the rules, standards and regulations for OPOs and transplant centers. Most are voluntary and only become mandatory when the Secretary of HHS signs off on it. The field is evolving and we need the freedom to move ahead. He is concerned that if CMS adopts (as regulations) too many OPTN standards, the field will be tied to them when the field needs to move ahead. Dr. Sollinger concurred and said that people are worried it will take another three to four years to change something that will benefit the patients if the field evolves. He cautioned CMS that it needs to be flexible in the process.
Ms. Newton said that CMS wants the regulations to be very high-level. An example is the requirement for the surgeon and physician. At one point, CMS thought about taking all of the OPTN requirements for training surgeons and physicians, but decided in the end to just include that these providers have to be identified and have the appropriate level of training and experience. CMS knows that "appropriate" means OPTN-approved. She continued that there are places where CMS might be specifying requirements too far down. One of its intentions was to give clout to the OPTN requirements. If there is a change that needs to be made and it has the support of the community, it won't take four years to occur.
Dr. Zhu said he had a comment on the technical aspect of the policy. He talked to people over the break and did some calculations, and it seems that the criteria favor small patient volume. For larger centers, it's more disadvantageous. He encouraged CMS to look at the criteria more carefully. Dr Hui-Hsing Wong (from HRSA) said that they had done the calculations on flagged centers and the system did not favor smaller centers when put into practice.
Mr. Seely opened the public comment period and noted that this is for public comment to ACOT, not to CMS, on the proposed rules. He reminded the group that there is another public comment period tomorrow afternoon before the full ACOT deliberations on the Workgroup recommendations.
Katrina Crist of the American Society of Transplant Surgeons (ASTS) spoke first. She said that the ASTS and the American Society of Transplantation (AST) have established a joint task force to review the CMS regulations. It is important to point out that collectively, these two groups are comprised of over 3,000 experts, scientific investigators, transplant surgeons, transplant physicians and others that together represent about 98 percent of the practitioners in the U.S. The task force involved a diverse group of 15 surgeons and physicians and was chaired by Mike Abecassis of Northwestern University.
The AST and ASTS have serious concerns about the CMS proposed regulations. First, they are concerned about the standards and processes to be used for initial approval. The proposed initial approval process appears to deny any opportunity for explanation, remediation, or survey for those centers that fail to meet the proposed data submission and outcomes data. This is a problem since neither the data submission nor the outcome standards was intended to be used in this way, but to be used rather as a "trigger" for further investigation by OPTN. They think that CMS should defer the outcome requirements until the OPTN review process has been concluded and should only consider termination of a center if the OPTN reports to the Secretary that the center is not in good standing with the OPTN.
If CMS decides not to rely upon OPTN's review and remediation process, the rules should be modified to provide an alternative process for review and remuneration. CMS and OPTN requirements need to be better coordinated.
Generally, they think the rules do not set forth standards for re-approval. If CMS continues to believe that Medicare conditions of approval for transplant centers should be independently enforced through state survey agencies prior to the OPTN's reporting a center to the Secretary as "not in good standing," a number of changes should be made to assure consistency between CMS and OPTN requirements to the extent practicable and to better coordinate the two processes. Finally, the proposed rule fails to set forth the standards for re-approval with enough specificity.
They met with Sean Tunis, Rachael Weinstein, Marcia Newton, and others at CMS in March, and CMS was receptive to the concerns. We hope that ACOT will bring our concerns to the attention of the Secretary in your recommendations. The ASTS/AST has 23 pages of comments, and they are happy to share copies of these comments with ACOT.
Vickie Hurewitz spoke next. She introduced herself as the widow of Mike Hurewitz, who died in 2002 when he was a live liver donor at Mount Sinai. She said that she came to the ACOT meeting after about two years of not being active in the live donor community. She said that she was disappointed in how far things have not progressed in that time. The CMS regulations, as they stand, do not include things that would offer protections for her husband, nor for Danny Boone. Donor selection criteria are needed that are imposed from outside and adhered to. Mount Sinai had live donor criteria — that included not accepting a donor over age 55 — but they overrode their own criteria when it was in their interests. Her husband was 57 when he was a donor. The reason the Feds have not stepped up yet is because they have not been mandated to do that. A law is needed that will protect living donors. The main thing needed is more information: what has happened to the 700+ live liver donors, to the people who are being operated on now? Informed consent cannot be discussed until it is known what happens with the donors over time. Her husband was told that Mt. Sinai had done 200 operations and lost one person, but that wasn't true. Nothing is in place to protect the live donor. Mrs. Hurewitz said that she feels that it is immoral to ask people to donate their organs — it's an emotional situation and the transplant community needs to protect the donors. The entire day has been about presentations on data about the centers and how well they are doing. It's unacceptable that there are no data, even now, about what happens to the donors themselves.
Dr. Sollinger said that one of ACOT's former members has a specific interest in this area, and he asked Dr. Delmonico to respond. Dr. Delmonico reassured Mrs. Hurewitz and Mrs. Boone — and other donor families — that we are very concerned about live donors. He verified that NIH is studying live donors and tracking live liver donors. In addition, internationally, in September, there will be a conference at which every live liver donor surgeon will come together to discuss this issue. The community has — as a priority — the interests of the live donor.
Dolph Chianchiano from the National Kidney Foundation spoke next. The National Kidney Foundation has filed their comments to CMS on OPOs and is working on their transplant centers regulation comments. The Foundation is concerned that the regulations do not encompass recommendations from ACOT for living donors.
Paul Schwab from the Association of Organ Procurement Organizations (AOPO) was the next speaker. In terms of addressing ACOT and not CMS, their experience sees the CMS rules as affecting transplant centers and OPOs. This is really a chance to have an opportunity to look at the symmetry — or lack of that — in the two regulations. For example, for OPOs there is a new appeals process proposed. But, in the transplant centers regulation, no process is proposed; the regulation only includes a comment on what the process should be. In OPOs, there is encouragement of outcome measures for DCD, but this is not included in the transplant centers regulation. The transplant centers regulation has outcome measures — you can see the influence of Dr. Merion and SRTR — but that's lacking in the OPO regulations. AOPO questions the rationale behind the symmetry, and/or lack of it, between the two regulations. The AOPO is in process of drafting our comments and would like to highlight several things:
Dr. Sollinger asked for a copy of AOPO's response and Mr. Schwab said he would be happy to provide that to ACOT.
Charles Alexander from the Transplant Resource Center of Maryland spoke on behalf of National Association of Transplant Coordinators (NATCO). He said that NATCO's assessment and comments to ACOT are essentially in line with what Mr. Schwab said. NATCO has concerns about the benefits of the Collaborative being lost. Many business models show the benefits of collaboration over competition. There were a few comments about the certification process. Specifically, there is a mention of the CCTC certified coordinator that is not mentioned in the regulation; it's important on the OPO side and NATCO would like to see this on the transplant center side as well. Transplant centers need to have an advocate for living donors, and NATCO believes there should be a patient advocate for living donors who is not on the transplant team. In terms of the DSA, NATCO is very encouraged by the Collaborative efforts. Organ procurement organizations have been effective at pursuing donations. Regulations should be congruent on the OPO and hospital sides in order to maximize donations. SRTR and risk-adjustments need to be accounted for; as a DSA, we should all be aiming at the same direction.
Dr. Sollinger noted that the public comments were completed and closed with a personal story. He said that he did a living kidney donation a few days ago and everything went well. Before he does a live donation, he said, he is always nervous. The responsibility is so enormous. Despite the criticism that not all the regulations are in place and executed yet, Dr. Sollinger said that he is certain that there is a tremendous awareness of the responsibility among the surgeons and centers around the country when dealing with live donors. We all take it very seriously. He wanted to mention this because he thinks everyone feels the same way.
The public portion of the meeting concluded for the day and the Workgroup began its meeting.
Mike Seely, Pacific Northwest Transplant Bank, Portland, Workgroup Chair, ACOT
Mr. Seely thanked everyone for their efforts on the various conference calls and noted that everyone had given good input. The members have received the notes from the calls. He discussed the charge to shape a comment to the Secretary, which shifts the gears a little from the CMS discussion. The recommendations are not going to CMS. The ACOT Workgroup does not have the ability to write a 40-page document on the CMS regulations, and the Secretary won't want to read all that.
He distilled the three recommendations discussed on the calls to some samples for discussion. In the next 24 hours, these recommendations will be revisited to see if they can be worded better and to get a preliminary vote on the proposed recommendations. The Workgroup can schedule another call to finalize the background information once the recommendations are approved by the whole Committee. He added that the group might want to add something about living donations to be responsive to the issues that were heard during the public comment period.
Dr. Freeman said that this recommendation is just what had been discussed, but it should be framed positively — see Federal Registerpage 6095 last column, where CMS asks for alternative review criteria and sought comments on the competition options. One of these alternatives is what ACOT is recommending. It might be better to say "ACOT strongly supports option X (whichever one it is)," putting the recommendation in a positive framework.
Mr. Seely said that the bulleted discussion point that followed could be integrated into the recommendation ("after de-certification, a competitive framework would exist"). He suggested removing the first sentence and saying that ACOT strongly supports the alternative option for OPO recertification that utilizes the highly restrictive process outlined on page 6095 of the Federal Register. The discussion could address the fact that there is no review process per se; there are issues in the decertification process around the short time frame and that the newly proposed appeals process is inconsistent with appeals process, as Mr. Schwab (AOPO) had commented.
Mr. Schwab remarked that the transplant centers regulation does not propose any appeals process and the proposed rule indicated that CMS is open to comments in this area. In the OPO regulation, in contrast, what had been an appeals process used by all Medicare suppliers is proposed to be eliminated and replaced with an unarticulated process that raises questions about due process. AOPO wants an initial review to be conducted by an informed CMS staff member who would be a hearing officer.
Mr. Seely said that ACOT is concerned about the vagueness of the review process (the two-tier review process), as well as the truncated nature of the review process for OPO regulation and for the transplant center review process.
Dr. Higgins asked if the group was concerned about the lack of definition about compliance and certification. They have heard changes in what outcome measures should be — all of these things are uncharted in terms of performance measures.
Dr. Freeman suggested adding a statement about measurement and OPO regulations. There is only one measure, the conversion rate. The definitions of the denominator are provided (see page 6099), and we should point out that CMS is using inappropriate details. Viral septicemia is listed, but what does that mean? He thinks CMS confused ECD with DCD. Ms. Gunderson said that she had asked, and Ms. Newton said that ECD is not included in the denominator in this regulation. Ms. Turrisi commented that people are mixing up the OPOs and the transplant centers regulations.
Dr. Freeman said that ACOT should point out that this is a level of detail CMS should not get into in the regulations because the regulations and the practice are going to change. What an ECD is today will change over time, so it may be appropriate or not to count them for OPO performance. The regulations should not go into this level of detail.
Mr. Seely asked if we recommend that ECD donors not be counted, then what should be the uniform definition of a donor. In his OPO, 30 percent of the donors in 2004 were ECD. Do we want it in the denominator or not? Dr. Freeman commented that you will have a lot more organs than donors and will look great.
Mr. Seely reminded the group of the major points they should emphasize: (1) ACOT supports a limited competition re-certification method; (2) CMS must have standard definitions for outcomes and performance measures; and (3) ACOT recommends a certification process that is thorough and provides ample opportunity for review.
Mr. Schwab said HHS would argue that there is a definition for the submission of data to OPTN currently performed by the OPOs. On page 6099 of the Federal Register, in the right-hand column, there is a set of criteria for organ donors. CMS says there is no standard application and the intent is to adopt the OPO definition.
Dr. Freeman reiterated that there should be room for evolution of the field over time. He asked if the recommendation could be worded to say we don't want the detail, but there should be a review process and the denominator may be changed more quickly. Ms. Turrisi added that it's questionable as to who has input into making the changes. Dr. Freeman said this is the crux of all of the regulations. Hopefully, all these definitions and measurements will be changed, e.g., ECD didn't really exist before. The ultimate issue is, if CMS goes to this level of detail and writes current definitions and then the OPTN, ACOT, or someone else comes up with new definitions, then what? We end up with parallel processes and different definitions which will cause problems. ACOT should point out where CMS is dipping into levels of detail where this is likely to happen. The denominator should be determined on a regular process. ACOT can recommend that CMS take into account the inevitability of changes of measures.
Ms. Gunderson said that OPOs are part of the OPTN and should be at the table. Are the outcomes of the OPOs in the purview of the OPTN? The OPTN doesn't have any jurisdiction over them, and no control over the OPOs, which is creating this very opportunity. CMS is supposed to be giving OPTN the teeth to move ahead with oversight over OPOs and transplant centers. Mr. Seely said that it doesn't make any sense to have all these things in the numerator and not in the denominator. Dr. Freeman suggested that CMS is at a different level in terms of monitoring transplant centers. CMS is not as far ahead in terms of monitoring OPOs. This is better managed at the OPTN level than at the Federal level (e.g., by CMS).
Mr. Seely read the other draft recommendations:
Ms. Gunderson stated that there isn't a lot of consistency about this because there are questions about what the definition means. It's hard to count it in the numerator and not the denominator. The potential donor denominator comes from left field and no one knows what this is. ACOT can recommend consistency of using definitions that are being used in the field. Mr. Alexander commented that, if you talk about ECD and DCD, the ECD is not always over 70 and is not counted. There should be a level playing field for measuring.
Mr. Seely noted that the group has concerns in several areas: the regulations conflict with one another (e.g., OPTN, OPO); performance measures; inconsistencies in data measurements; there are very specific and prescriptive staffing requirements; the appeals process is lacking for transplant centers for the initial application; there are conflicting definitions as far as DCD/ECD which are defined for risk adjustment for OTCs, but not for OPOs.
Dr. Freeman said that some measures are totally arbitrary — the greater than three rule, for example, the 1.5 ratio, likewise. Regulations have to acknowledge the inevitable evolution of measurements and incorporate this so that CMS stays in sync with OPTN. Dr. Conti said that there have to be standards, and programs have to know what the standards are. He asked how we incorporate flexibility to get there. Mr. Seely commented that ACOT needs a statement that captures this point so the Secretary will see it. The group can probably put forth just two or three recommendations. Dr. Higgins agreed, but noted that ACOT has to actually say something that will be helpful to improve quality of transplantation and move centers along to better practice.
Dr. Freeman suggested that ACOT recommend that CMS regulate what it will and will not pay for. Transplantation is different. ACOT is more like the OPTN in its ability to be responsive and keep up on practice. Things change; it's inevitable. CMS should be consistent with OPTN. Mr. Balbier said that it is useful to suggest that the OPTN can monitor the centers, and so forth, but there still needs to be oversight from the Federal level. He reminded ACOT members of their responsibility to make recommendations only to the Secretary, and not to the OPTN, about organ transplantation matters.
Ms. Gunderson stated that, if regulations have to respond to the evolving industry, then do we think that ACOT should push to expand OPTN authority to enhance quality and do oversight from other departments? Dr. Freeman answered that ACOT should outline where the regulations are prescriptive of medical practice and give CMS examples. The transplant centers regulation includes several examples of things that OPTN has already addressed, for example.
Mr. Balbier said that, if the Workgroup can come up with draft recommendations to present to the full committee tomorrow, and the full committee agrees with the language of the recommendations (not necessarily including the introduction and discussion points to be included in the letter to the Secretary), it will be beneficial.
Ms. Turrisi said she wanted to add a recommendation about living donors. ACOT has previously made some suggestions that have not been implemented. The living donor registry needs to be established so that we can track living donors. Transplant regulations say that you have to inform about the short- and long-term risks. ACOT recommended this previously and we should note that, without the registry, this part of the living donor regulations cannot be complied with.
Dr. Freeman said that there is a small Request for Proposals (RFP) out on this, but it's not to create a central database for living donors and is completely insufficient to meet the need. Every group has recommended a donor registry similar to what is captured about recipients. Mr. Balbier suggested that making a living donor recommendation might be considered outside the scope of responding to the proposed CMS regulations. Ms. Turrisi responded that in order to do accurate informed consent, as mandated by CMS, a better system for tracking living donors has to be implemented. Ms. Gunderson called the group's attention to the Federal Register, page 6181, far right column, where CMS says that you have to tell patients outcomes for both donors and recipients. ACOT can say that this information cannot be provided without a registry of living donors.
Dr. Freeman noted that the government representatives told the OPTN to stop thinking about living donors because it's not in NOTA. This is a problem in terms of authorization. UNOS could do this if it wanted to; they don't need a law to tell them to do it. Mr. Seely said that this is precisely ACOT's role, to recommend this sort of thing. We can recommend that NOTA give expanded authority to the OPTN to address living donations in a manner similar to what exists in terms of deceased donations.
A sub-group of the Workgroup continued to draft language for the proposed recommendations.
Dr. Sollinger welcomed the group back for the second day of the ACOT meeting.
Robert Metzger, President, United Network for Organ Sharing
Dr. Metzger thanked the committee for the opportunity to present before ACOT on these important issues. The issue of public solicitation of organs is growing in scope, but goes back at least 25 years. In fact, President Reagan once made a public appeal for a child who needed a liver. There are many means for asking for organs that include talking to other people, going through a church bulletin, using public means like advertising. The newest means is through the Internet, using the web as a way to solicit organs. It's being driven by the fact that the waiting list is expanding and the number of deceased donors cannot meet the need. The waiting time is, on average, about five years.
There are several laws that allow public solicitation. Most important, is the First Amendment, which grants freedom of speech. The Uniform Anatomical Gift Act specifically allows directed donations, and donations to a specific OPO or surgeon. While NOTA prohibits buying and selling organs, people can pay for travel and living expenses. The ethical issues include autonomy and the donor's right to say where their organ should go. Another factor is informed consent, which is a huge issue for living donors. We also have to keep in mind equity, so that similar patients get treated similarly, although some recipients, like children, are treated differently. Dr. Metzger noted there is very little included in NOTA around living donors. He reported that, in the HRSA's new Request for Proposal (RFP), the OPTN's authority on living donors will be expanded.
Much of Dr. Metzger's discussion involved the use of the Internet to solicit organs and the site Matchingdonors.com , which charges a fee to be listed on its pages. The size of the fee, $295/month, raises ethical concerns, although the site has lowered its fees and said that one does not have to pay to be listed. The major concern about public solicitation for directed donors is that this subverts donations for people who are more critically ill and who need the organ more desperately. It undoes the purpose and role of the waiting lists. What would be better would be to promote overall appeals of organs for everyone, rather than selected donations.
Dr. Sollinger noted that he recently received an email from a hospital administrator saying that Matchingdonors.com sent a memo asking that centers willing to accept their donations agree to being listed on the site (i.e., Matchingdonors.com ). Dr. Metzger noted that he thought everyone in ASTS got that memo last week. After the Bob Hickey (website-arranged) transplant, both ASTS and AST issued statements on Internet solicitation. They are now working on a joint statement on Internet solicitation. The groups are being lambasted on the Internet for not recognizing the web as a bona fide means of communication and community-building no different from a church bulletin or interpersonal solicitation. Dr. Metzger stated that it is paramount that neither person be exploited and said that, absent a meaningful personal relationship between the donor and recipient, the OPTN system should be used instead of this kind of directed donation.
Ultimately, the transplant community needs to look at the issue of transplants facilitated by the Internet and accept that the web is a form of communication, that people do have relationships facilitated by the Internet. It may increase donations because people feel connected. On Living Donors Online , for example, there are 260 pages of archived materials from people who are willing to donate. UNOS is soliciting public comment and will be holding a meeting to get input on this issue and on ways to facilitate living donations. The OPTN/UNOS Website may be useful in helping those who want to donate, or the group might work with Living Donors Online .
Dr. Sollinger said that he is glad this is coming up, and said it was going to be a huge issue. He put himself in the position of a patient; if someone said he had to wait five years, he'd put myself on a website and hope for the best. When you are sick, things change. Dr. Kahan said that Houston has had these types of billboards and people are very concerned about it. In his center, which is the largest in the country, there is a major problem with recipient families trolling the ICU waiting rooms and soliciting donors from critically ill patients' families there, talking them into directed donations. His center's approach has been to limit these donations to a second degree relative (e.g., cousin) and to talk with the ICU families about equity issues and encouraging them to use the regular allocation process. They also exercise a lot of caution over the donors, and even Google them to get a little background.
Dr. Kahan continued that another problem is patients going overseas to get an organ through websites like medcare. For this group, if you pay $14,700, they will fly a patient to an undisclosed site (China) for an operation and aftercare. ACOT and OPTN have the responsibility to warn people about this. Dr. Kahan stated that in Houston they see these patients all the time. The recipients have not been worked up, there are no records, the records are in Chinese, and it's a big risk (and ethical problem) taking organs from Chinese prisoners. The organs have not been evaluated, and people think their follow-up care is going to be covered in the U.S. but it's not. Dr. Metzger agreed that this is a real concern and stressed that he hoped ACOT would act on this.
Dr. Sollinger commented that this just reflects how desperate people are. He feels that UNOS should quickly move to be the Website that helps people and connects them. It will happen anyway so why not have people with the best background and authority make the connections and charge either very little or nothing. If there are hundreds of thousands of people who want to donate for nothing, who can be screened at reputable hospitals, we may be able to solve our donor shortage problem. It can be good, so long as we screen people well, do the surgery at a good hospital, provide good care, and no money changes hands.
Dr. Freeman said it's important to distinguish between deceased and living donor solicitation. It's clear that the public does not understand the difference between the two issues. He feels that directed deceased donation is a subversion of the system that is designed to be fair and ethical. In his opinion, ACOT should not condone directed deceased donations. ACOT can also recommend that the OPTN create a matching donor live Website, but this has not happened because of OPTN's reluctance stemming from a lack of explicit authorization through NOTA. It's not clear if HRSA can do this without NOTA authorization. Dr. Metzger reported that UNOS has approval from HRSA to do this and is moving ahead.
Mr. Balbier reminded the group that, in terms of making a recommendation to the OPTN, ACOT's role is to make recommendations to the Secretary of HHS, not to the OPTN. Dr. Freeman stressed what Dr. Sollinger said, that this should happen quickly and ACOT should recommend that the Secretary encourage the OPTN to develop a system quickly.
Ms. Turrisi added that the recommendation should be to tighten the safeguards for living donors so that they get the right information. ACOT has talked about the lack of a living donor registry as being important; and we don't want to have people regret the gift because they didn't have all the information. Dr. Metzger agreed, saying that's why they wanted to do the Website because they can provide helpful information to people.
Dr. Young commented that the desperation is really critical and that everyone needs to be respectful of the situation people are in. ACOT should also recommend to the Secretary that a system be created to track the living donors and follow up with them, to make sure they get insurance, information, and medical care.
Dr. Kahan asked the group to bear in mind two principles: first, anonymity. The Websites foster known donors, and it's important to preserve anonymity or people become indebted. Second, equity: If we have a Website and only a fraction of the recipients can afford $9 a month to be listed, it's not equitable. The donor pool has to be open to all if it's done through the OPTN. At his center, they keep the donor and recipient separate and don't introduce them. Both anonymity and equity have to be preserved in any system.
Mrs. Boone asked who is really in charge of living donations. If there is no organization that is in charge, how do we create such a thing? She said that someone has to make the rules and see they are followed. Dr. Metzger answered that, at present, it's with the transplant centers. In the newly awarded HRSA contract, the OPTN will get more clout to monitor and create more definitive criteria. Dr. Sollinger reminded the group that one may as well ask who is in charge of heart transplantation — it's always the transplant center. Transplants have more oversight and Federal control than other fields of medicine, however.
Mrs. Boone asked if ACOT can recommend to the Secretary that there needs to be changes in law to get this done. Dr. Sollinger said that, once the NIH data are available, there will be a site where you can see morbidity and mortality among live donors with a mandatory five-year follow up and reporting. He said he is really interested in the kidney donors after 5-10 years.
Dr. Sollinger asked if the ACOT members agreed to send a message to the Secretary to recommend rapid and intense communication with the OPTN regarding establishment of a donor recipient matching program that will be the authorized site for live donor matching. Dr. Freeman added the caveat that this includes important information about both the risks and benefits of being a donor. Dr. Young moved to accept the recommendation, and Mr. Turrisi seconded the motion.
Dr. Kahan said there should not be a charge to someone who wants to register as a potential live donor, either for assessment or surgery. Dr. Higgins reinforced Dr. Kahan's point, saying that anonymity makes donations more equitable for people who can't afford it. Ms. Rosenzweig commented that many people are on the websites not for monetary gain, but because they have a real passion to connect with a person and help them. Once you take that connection away from them, then there isn't the same response. While she supports the recommendation, she cautioned that this won't be the end of it. People want to know their recipient and vice versa. We will end up with multiple websites and we either have to live with it or try to stop it. Of course, it can't really be stopped.
Dr. Freeman said the group needed to be clear about what it's talking about. Matchingdonors.com connects people who want to know their recipient, and a list of donors maintained by the OPTN will not accomplish this nor make these websites go away. He also said that donors ultimately make their own decision. Saying the donors are being "protected" gives the impression that they are being exploited and unknowingly putting themselves at risk.
Mrs. Boone disagreed, saying that her experience was one of organ transplantation at its very worst. Her family needed protection from this. Her husband was misled and misinformed and, after he died, the experience was a nightmare in terms of the response of the surgeons. Thankfully, few people have this experience, but "protection" is exactly the right word until we can be assured that living donors get all the information they need.
Mr. Seely asked for a moment of order and to have the recommendation read again.
Dr. Kahan said the recommendation is "to ask the OPTN to consider establishing a Website that would serve as a clearinghouse for referral of potential donors and potential pairs of donor-recipients." Dr. Sollinger clarified that it would be that "ACOT urges the Secretary of HHS to interact with the OPTN in an urgent fashion to establish a website which facilitates the matching of donors and recipients."
Ms. Agrawal asked if ACOT was about to ask the Secretary to approve a known living donor-recipient match at a time when we don't know how well developed the informed consent process is or what the outcomes are. She stated she was not sure if the government has all the pieces in place to speak to this yet. Dr. Sollinger proceeded to call for a vote, which occurred with 10 in favor, 7 opposed and 2 abstaining.
Robert Metzger, President, United Network for Organ Sharing
Dr. Metzger gave a brief presentation on kidney allocation, noting that the list has 62,000 people on it. Most kidneys are allocated at donor service areas; when not used nationally, a kidney is allocated at the local level based on a number of points on the DR match. He showed maps of donation service areas and local allocation maps. UNOS tries to give organs with the best benefits; it has just implemented a new lung allocation system and is looking at the goals of the kidney allocation system. UNOS is looking at the allocation systems to follow the lead from liver and lungs and to improve morbidity and mortality of patients on the waiting list.
Dr. Metzger showed information on the causes of kidney allograft loss after the first year post-transplant. The question is whether kidneys are being put into patients who will have a long life with that organ. The hope is that the Breakthrough Collaborative will increase donations, but he noted that there is a need for improvements in dialysis, which will also decrease the need for transplants. The field has settled on doing dialysis three times a week but might benefit from looking at doing dialysis daily in the future.
UNOS held a special board meeting in March on the kidney allocation system; and new goals are being discussed. They are looking at efficiency, which is a big problem in kidney allocation. With new technology, they hope to have a system so that the coordinators won't have to make a call on every offer. They want to do blast updates to larger groups of centers so then they won't have to call every center with someone on the list.
Dr. Sollinger said he remembered a paper co-authored by Dr. Kahan, from 1995-6, predicting that the national kidney sharing would result in .3 percent in improvement outcomes; in other words, a negligible improvement. He said he thought Kahan et al were right; that is, shipping kidneys all over the country has been a major headache for transplant centers and has led to delays and conflicts with operating groups. Sollinger's OPO has considered hiring a lawyer to look at UNOS regulations so they are not in violation of any of the hundreds of pages of guidelines.
Dr. Kahan said that his hospital had a problem because it was shipping so many kidneys out and there was a lot of negative reaction for that. The changes are long overdue although it's going to be difficult. Where the OPO is not functioning well, they are accumulating a large number of patients.
Dr. Metzger said that UNOS needs to look at the burden of disease for people. There is a DSA Task Force, which has held its first conference call and will meet during May to look at monitoring DSAs for productivity, exploring best practices for OPOs, and bringing them into monitoring for the OPTN. UNOS is setting up criteria they need to meet and helping them get up to speed. The CMS and OPO regulations will hopefully do the same thing.
Angela Tagliaferri from Cleveland Ohio spoke first. Ms. Tagliaferri said that she had not planned to speak but wanted to talk about living donations. She is not the spouse of, or doctor of, or relative of, a living donor. She is a living donor herself. She commented that there needs to be something in place like the website, and agrees with Ms. Agrawal's comment about nothing being in place to take care of people like her. After her surgery in 2001, she went back in to have her incision looked at and was told she was okay and they just sent her home. She couldn't get anyone to take care of her and had to beg the Cleveland Clinic to look at her. There needs to be a push — as fast as possible — to put something into place to take care of people like her because no one does. She said that if ACOT and the community are going to push living donations, then they have to make sure someone takes care of the living donors.
Dr. Sollinger commented that no one disagrees with Ms. Tagliaferri. As a practical matter, at his center, they would look at the patient whenever he or she showed up with a problem. Ms. Tagliaferri might have a different insurance company and his hospital might not accept it, though. This is a real problem we have to get around. Live donors should have life-long coverage of some kind.
Mrs. Boone asked the group if they had any idea how many live donors become uninsurable because the donation is seen as a pre-existing condition. Dr. Sollinger stressed that this is a huge problem and that ACOT should communicate this. There is a lot of concern on the patient and donor side, as well as on the medical side, that there should be life-long care for donors.
Vickie Hurewitz, widow of Mike Hurewitz who died as a result of a liver donation operation, spoke next. Mrs. Hurewitz said that before anyone opens up living donations to the public (without relational connections), there needs to be a law to protect or regulate living donations. It is not fair to ask people to do this without there being a law in place. If UNOS needs to take a position, they should take the moral high ground and say they are working to get laws in place to protect the living donors. Until such a law is in place, UNOS should say it can't support wide open donation. When the vote on the recommendation was taken, she noticed that the surgeons voted yes, and the non-surgeons voted no. Surgeons cannot be objective; they are trained to conduct surgery and their view is very different. The decision should be taken from them and put in the hands of ethicists.
There were no addition public comments and the panel broke for a break.
When the meeting reconvened, Dr. Sollinger apologized and noted that protocol was not followed in making and voting on the recommendation. ACOT can vote on a recommendation only when all public comments have been heard. He wanted to go back to the recommendation and rephrase it to incorporate the public discussion. He said that he listened very carefully to Vickie Hurewitz's comments and they needed to be addressed in the recommendation.
The proposed revised recommendation was projected for the ACOT members' review:
Mr. Seely moved to reconsider the old recommendation; Dr. Freeman seconded the motion. ACOT voted unanimously to withdraw the original recommendation. Mr. Seely then moved to consider the revised recommendation, and Dr. Zhu seconded it.
Ms. Gunderson suggested changing the proposed language to read "OPTN be asked to expeditiously consider... "
Mr. Seely read the final recommendation:
Dr. Sollinger called for a vote, which was unanimous in favor of the new recommendation.
James Childress, University of Virginia, Institute of Medicine Committee Chair
The presentation concerned the initial discussions from IOM on increasing rates of organ donation. Dr. Childress noted that this is very early in the process. The IOM Committee has had one meting and benefited from hearing from several people, including Ms. Agrawal. Ms. Cathy Liverman is the IOM senior program officer working with the study and Dr. Childress noted that she has been a great resource.
The statement of task is for the IOM Committee to convene an expert committee to examine issues surrounding organ donation and to evaluate the ethical implications of proposals to increase deceased organ donation. The purpose of this study is to provide advice to the Secretary of Health and Human Services in support of legislative requirements of the Organ Donation and Recovery Improvement Act.
The Committee will examine a broad range of proposals to identify ethical implications; evaluate their impact on donation efforts, public perception, and, especially, on disadvantaged or disproportionately affected groups; and make recommendations about how proposals can be effectively implemented to reduce ethical problems.
The Committee tasks are to:
The goal is to release the report in Spring 2006. The IOM Committee won't have any information to present before the Fall ACOT meeting because it will be in the process of drafting the report. Dr. Childress noted that there was an opportunity for members of the public to speak at the August meeting and the committee eagerly solicits submission of written materials at any point. More information is available at The Institute of Medicine web site .
Dr. Kahan congratulated Dr. Childress for taking on this issue. Many people have been looking at this issue for years, so the goal of issuing a report in 18 months is really quite a charge. It's frightening because the issues are so multifaceted and there is so much material. It's an awesome burden. Dr. Childress responded that the committee is well aware of this and does not have any pre-conceptions about where it will come out on any of these matters. It may only be able to offer pros and cons and point to the need for more evidence. The committee is not going to rush to judgment. However, if there is more information needed, then that will be called for in the report.
Dr. Freeman asked if the issue of public solicitation will be addressed. Dr. Childress confirmed that it would be, especially as one possible way to increase rates of donation. Dr. Zhu noted that three of the committee's panels will address incentives. It seems, for donors, that a huge area of concern is access to follow-up care and insurance coverage. Is this going to be part of the IOM's examination? Dr. Childress said that one thing they were going to consider was removing disincentives such as the lack of follow-up care, informed consent, etc.
Mr. Schwab said that the last 19 months have shown increases in organ donations due to impacting health care providers (e.g., the Collaborative). There are ethical issues involved. AOPO is recommending that reimbursement be provided to hospitals earlier (e.g., before brain death). He asked if the committee will look at ways to influence health care providers. Dr. Childress affirmed that the committee will look at system changes on both the micro and macro levels and asked for people to let the committee know what these are and provide input.
Mr. Hagman asked if there has been input from insurers on this issue. Dr. Migliori also suggested that the insurance industry has to be connected and that the real issue is the on-going insurability of the living donor. Insurance covers the donation itself, and the recipient, but there is a need to address the living donor and the pre-existing condition issue. Mrs. Boone stated that it would be good to address this at the next ACOT meeting.
Dr. Freeman noted that there had been a plan to survey donors about their insurance issues, although it hasn't gotten off the ground yet. The IOM and anyone else who looks at it will see there's no information available. He said that we need to learn how often donors subsequently are turned down for coverage and what happens to them down the line. Ms. Turrisi pointed out that ACOT has discussed this before. She did a survey of insurance companies and there have been recommendations made before. There is a question whether living donors should be covered by long-term Medicare if they are denied by other insurers.
Dr. Migliori noted that insurance law and regulation always follows technology. The fact that there is the capacity to do living/unrelated donations means that the insurance industry has to focus on it broadly. The IOM should clearly address this.
Ms. Newton said that there is no CMS coverage policy for living liver donors. CMS did an informal survey and most Medicare contractors do seem to cover it. Dr. Sollinger remarked that, considering how much the government saves by getting people off of dialysis, CMS should cover this and it's worth paying for the donation. He suggested putting this issue as central for the next ACOT meeting. Mrs. Boone asked to also discuss other quality of life issues that matter for living donors.
Mike Seely, Pacific Northwest Transplant Bank, Portland, Workgroup Chair, ACOT
Mr. Seely said that the Workgroup had looked at both the transplant centers and OPO regulations. They had met over several conference calls and heard a presentation from CMS's Marcia Newton on the regulations that familiarized the members with the proposed regulations.
He reminded the group of the context for this effort, that ACOT make recommendations to the Secretary, rather than to CMS. ACOT is looking at the issue from a global level, and the detailed perspective is being received by CMS through many public comments. The Workgroup has developed three proposed recommendations for ACOT's consideration. After the meeting, the Workgroup will keep shaping the draft to include background and attachments for the Secretary.
The Workgroup felt that, in light of the discussion over the past few days, nothing in NOTA explicitly supports the living donation issue. It was felt that living donor informed consent provisions cannot be fulfilled without a registry and this cannot happen without amending NOTA. It was hoped that ACOT's previous recommendations had been better implemented by now. Without any mention of living donations in NOTA, the OPTN does not have any obligation or authority to take leadership in this area.
Mr. Seely read the Workgroup's proposed Recommendation I:
Dr. Freeman said that comes from the fact that, in the transplant centers regulation proposal, there are a lot of criteria that don't really exist uniformly. The issue is that the proposed rules cannot be met without this action happening first. Mr. Balbier read ACOT's recommendations 1 and 3.
Mr. Seely commented that if NOTA is silent on living donors, we need to find a way to give authority and oversight for this to the OPTN. Ms. Rosenzweig said that the proposed recommendation reads "legislation be pursued" and asked what that process would entail. She is not clear how ACOT wants to proceed with obtaining this objective. Mr. Seely said that there needs to be a legislative fix to make the law work. ACOT can word it differently, but it needs to be legislatively mandated. Ms. Rosenzweig said that one option is to go back to Congress and ask to amend NOTA or to pass something new. Alternatively, one could look at financing for care and that would need Congress to act upon it. Mr. Seely responded that NOTA would have to be revised for any funding to come about. Writing the rules came about because of legislative action, and the same process needs to put forth an amendment to NOTA for this to happen.
Mr. Balbier suggested it might be better for the recommendation to read that ACOT wants the "Secretary of HHS to propose legislation to expand the role of..." This could happen either by changes in appropriation or authorization. Dr. Migliori asked, given the recommendations related to transplant centers, what was the intent? Who would provide oversight? Mr. Seely responded that it was more like a vacuum — there is a discussion of living donations, but the authorization is missing. Dr. Freeman added that the Workgroup didn't want to get into the details of the regulations. There are living donor standards that aren't even included in these regulations. Logistically, there isn't a way to do the informed consent without tracking. The regulations state that the donors must be informed of the long-term risks, but there isn't a way to do this right now. ACOT is suggesting that OPTN take over living donation oversight so it's not prescriptive.
Ms. Agrawal said that she and Mark McGinnis, OGC, were not persuaded that NOTA needed to be amended to reach this goal. There is a mild concern that ACOT should not express an opinion that the Secretary doesn't have the authority to do something that he is already doing or is proposing in the regulations. Legal counsel can help determine what it is that needs to happen to make it occur. Dr. Freeman said that the concern has been that the OPTN hasn't acted yet because it does not feel it has the authority — maybe this is being reinterpreted, which would be good.
Mr. Seely read the proposed Recommendation II:
He noted that this stemmed from discussions about innovation in transplantation and the fact that ACOT does not want to prevent or limit innovation. This is aimed at the prescriptive language in the regulations. The regulations lack reliance on the existing network that allows for timely concordance between changing practice and policy, e.g., the ABO issue. Dr. Young asked if there will there be examples of the discrepancies given, and Mr. Seely affirmed that there would be.
Mr. Seely read the proposed Recommendation III:
He said this came from the support for the proposed highly restrictive competitive process in which only service areas of OPOs which did not meet the conditions for coverage would be opened for competition. Performance measures have to include multiple measures of performance. The appeals mechanism does not include enough due process and administrative protection.
Dr. Sollinger said that these issues are dangerous and could really tear the country apart if implemented. ACOT has to really push this. There are underperforming OPOs, but this is not the way to fix the problem. Ms. Turrisi said that this recommendation goes to both the OPO and the transplant centers issues.
Ms. Agrawal cautioned that the text does not read as recommendations in the format of "ACOT recommends that the Secretary of HHS" does or does not do something. They need to be in the proper form.
Dr. Conti suggested phrasing the recommendation to begin: "ACOT recommends that the Secretary restrict the competitive model to those OPOs who are determined to be underperforming" and then add the other language in the rationale. Ms. Agrawal offered to help with the formulation of final language outside the ACOT meeting.
Mr. Seely said that the preliminary vote is on the basic recommendations and, if approved in concept, the Workgroup would have a final conference call to finalize the language for the three recommendations and the transmittal letter to the Secretary, and then send everything to the full committee for a final review. Dr. Sollinger moved to approve the recommendations conceptually as presented, Dr. Conti seconded the motion.
Vickie Hurewitz asked about the recommendation on living donors in terms of what she can do as an advocate. If the law has to be amended in Congress, should she speak to her Representative? She asked how she can weigh in as a citizen before the Secretary of HHS. Ms. Agrawal responded that any member of the public can comment on the regulations and has the opportunity to do so. Mrs. Hurewitz asked how this process can be speeded up. Dr. Sollinger agreed that the process seemed slow to everyone, but congratulated Mrs. Hurewitz on having worked to improve and hasten the process.
The members voted on each recommendation in turn and all were approved unanimously.
Dr. Sollinger thanked the Workgroup for its efforts. He has looked at documents of other societies, and the common theme seems to be that the groups are concerned that the OPTN is being taken out of the loop. He said that former Secretary Thompson had signed an amendment to the final rule stating that the Secretary will only get involved if there is a high degree of non-compliance that is not being addressed by the OPTN. The goal is to avoid having an HHS Secretary come in and undo the OPTN process. It was intended to put a barrier between the Secretary and the OPTN.
Mr. McGinnis, OGC, stated that he was unaware of any amendment to NOTA or the final regulations, and he would have cleared any such document(s). He stated that there had been discussions about giving the OPTN more authority to set its own rules rather than going through full rule-making like it is now, but that did not happen before Secretary Thompson left office. Dr. Sollinger asked that the issue of an amendment to the final rule be clarified before the next meeting.
Hans Sollinger, Chair, ACOT
Dr. Sollinger stated that ACOT will continue to work on the ACOT recommendations to the CMS regulations as a high priority. Agenda items for the next meeting will include an update on the work of the Breakthrough Collaborative and consideration of the issue of a live donor registry and insurance coverage. Dr. Migliori was asked to survey the insurance companies about live donors and report on his findings. ACOT also will revisit the dot com issue.
Dr. Higgins proposed that ACOT examine deceased donor organ utilization because it appears timely to discuss this again with respect to the Collaborative. The fact that there are high levels of discards goes to the root of what the Collaborative is trying to do in terms of increasing the number of organs per donor. Mr. Seely stated that an OPO's performance is often tied to surgeons' attitudes and the Collaborative hasn't addressed that yet. If the surgeons are lethargic, they will fail. Perhaps ACOT can look at this with the help of the Collaborative and compare low-performing OPOs with their surgical staff's attitudes.
Mr. Balbier reminded the group that all of the ACOT recommendations are on the Organ Donor Website. Mrs. Boone said that she had recently petitioned the Medical Care Commission of North Carolina about living donations. She met with the North Carolina Secretary of Health and they have established a workgroup. North Carolina now is three days away from approving the document the workgroup created, which gives guidelines for living donations. The State is the second to do this, after New York. She suggested that the chair of the workgroup be asked to make a presentation to ACOT.
Miles Kaye said that he wanted to comment on one of Dr. Evans' earlier remarks, made during Dr. Delmonico's presentation. He has spoken before many transplant support groups and is an ambassador for an OPO. His wife is a recipient of a liver from a deceased donor. He said there is only limited and inconsistent information given to living donors and their recipients. The timing of getting this information is critical for ECD and SCD recipients. When facing death, can a patient really be involved in making the decision to accept or reject an ECD organ? Would a desperate person reject any organ? We need to be careful; we need standardization about the information that is provided and the timing of when the information is given to ESRD patients. Mr. Kaye also questioned whether a patient can handle being involved in any decision to accept or reject a specific organ at that point.
He also addressed Dr. Kahan's statement on anonymity. In his experience, all recipients are grateful to donor families and their donors. He has not met any recipient who didn't want to thank the donor family. His wife wants to thank her donor. Dr. Merion made a presentation on the SRTR models and, as a layperson he was concerned that most of the charts refer to one-year survival rates. Is the message being sent that we're only looking for one year survival? We need to see one-, three-, five-year rates, as well as extended survival rates, especially with respect to the costs to patients, the transplant centers, the government, and insurance companies.
Finally, Dr. Metzger referred to the "lesser" results seen among those who are over 65. Mr. Kaye was sorry his wife had to leave for another appointment because he wanted ACOT members to see a positive, 40-month post-transplant, 71-year-old liver transplant recipient from a deceased donor. He closed by thanking the members for their time and efforts for all ESRD patients.
Dr. Sollinger thanked Mr. Kaye and adjourned the meeting.