U.S. Department of Health and Human Services
Advisory Committee on Organ Transplantation

Introductions and Welcome
Nancy Ascher, M.D., Ph.D.
Nancy Ascher opened the meeting by thanking the members of the Advisory Committee on Organ Transplantation (ACOT) for putting aside any personal agendas to reflect on the big problems that face the field of transplantation in the United States. To date, this advisory body has accomplished 28 recommendations, many of which have had significant effects already. She touched on how the four subcommittees of ACOT are organized and noted that the lack of a sub-committee dedicated to minority issues per se is a reflection of the fact that these important issues cut across all the subcommittees.

Ascher recognized the many contributions being made by Committee members who are participating on roundtables and other discussions that affect what we have been doing. She specifically mentioned the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the meeting convened in September devoted to End-of-Life Issues.

Update on ACOT’s First 28 Recommendations
Jack Kress, J.D.
Jack Kress reflected on the accomplishments of ACOT and the official reactions of the U.S. Department of Health and Human Services (HHS) to ACOT’s work. He spoke about recommendations relating to the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS). He has discussed with the OPTN/UNOS board a process for handling ACOT recommendations pertaining to OPTN/UNOS. ACOT and OPTN/UNOS will continue to work together informally but will try to add a formal level of transmittal of recommendations via the Secretary to ensure that all recommendations are addressed. The transmittal will also mark an official handoff so that those recommendations will be cleared off ACOT’s “plate.”

Regarding the first set of 18 ACOT recommendations, the Secretary has charged various Departmental components and entities to work on specific aspects of the recommendations. The National Institutes of Health (NIH) is taking the lead on the major research portions of the ACOT recommendations. For example, the Secretary specified that the National Institute of Allergy and Infectious Diseases (NIAID) take the lead in responding to recommendations with living donation research components. The Secretary has specified that he desires fast results. Some recommendations will require epidemiologic studies and rigorous review of data. The Division of Transplantation (DoT) of the Health Resources and Services Administration (HRSA) and the Centers for Medicare & Medicaid Services (CMS) will also be involved so that the information generated may form the basis for a cohesive approach to transplantation within HHS. To maintain the timetable, at least one funding proposal will be brought to NIAID in January 2004.

Specifically, for Recommendations 1, 2, and 3, NIH has been charged with developing a research agenda for full disclosure, counseling, and so forth with respect to living donation. Recommendation 9 calls for research into existing disparities in transplantation rates and outcomes. NIH will spearhead this research, as well. Recommendation 22 calls for encouraging the use of split livers as a matter of national policy. An HHS working group recommended more data analysis, which will be undertaken by NIH. Jay Hoofnagle of the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) will take the lead on putting together a workshop on the state of the science regarding transplantation of split livers. (Jay Hoofnagle asked that any members of the transplant community who wish to be involved contact him through Jack Kress.) Recommendation 24 has also been taken up by NIH.

Kress then reviewed the progress of the first 28 ACOT recommendations:

• Recommendation 1 (two informed consent documents): First, NIH will be involved. Second, there will be some discussion by CMS because the recommendation involves protection of living donors. Third, OPTN will be involved because the thrust of the recommendation is that the OPTN take this on. The ethics subcommittee is developing guidelines for living donor evaluation.
• Recommendation 2 (independent donor advocate): NIH is addressing this recommendation in part as are CMS and OPTN through DOT review. At the OPTN level, work is ongoing to define the role of the living donor independent advocate.
• Recommendation 3 (establishment of a registry or other means of getting good detailed information for potential living donors): NIH is involved. Additionally, the OPTN ad hoc living donor committee is revising the liver-lung forms, keeping these recommendations in mind. Hoofnagle is involved as well.
• Recommendation 4 (resource center for living donors and their families): OPTN’s ad hoc living donor committee recommends setting up a central information center, to include a Website.
• Recommendation 5 (extending additional preference to any living donor who needs an organ): OPTN is now considering action on this recommendation and is seeking guidance from OPTN committees.
• Recommendation 6 (that the requirements for HLA typing of liver transplant recipients and/or living liver donors should be deleted): Action on this recommendation has been completed.
• Recommendation 7 (a process for verifying qualifications of centers to do living donor transplantation): The board of directors of OPTN has addressed this issue by recommending standards for certification. The Secretary is behind this recommendation in order to support living donations.
• Recommendation 8 (increasing education and awareness of dialysis patients about transplantation options): CMS will be looking into this as part of its review of the ESRD medical evidence report form.
• Recommendation 9 (research into existing disparities in transplantation rates and outcomes): This recommendation has been incorporated into the research agenda, as described above.
• Recommendation 10 (legislative strategies to encourage medical examiners and coroners not to withhold lifesaving organs and tissues from qualified organ procurement organizations): Mike Seely reported on this recommendation during a subsequent presentation.
• Recommendation 11 (core curriculum standards for public education as well as in the curricula of professional schools): The Secretary of HHS in concert with Secretary of Education has called for incorporation of transplantation issues in core curriculum standards. A letter has been signed by the Secretaries to encourage adoption of specific modules to be released in January 2004. Assistant Surgeon General Kenneth Moritsugu has also taken up this cause. Some specific initiatives have been targeted for departmental action: for example, a model program for high school students. At the July 2003 meeting of the National Education Association, the programs were previewed. A completed curriculum has been reviewed and revised by HRSA. As these programs and curricula receive full Departmental approval, they will be reproduced on CD-ROM for distribution to schools around the country. Materials are being translated into Spanish, as well. The Secretary’s Office of Intergovernmental affairs and other bureaus within HHS plan to meet with various professional associations about the other aspects of this recommendation.
• Recommendation 12 (best practices related to management of potential donors): This recommendation, as well as recommendations 13, 16, and 17 all relate to a major best practices initiative and the Breakthrough Collaborative program to support improved protocols. Identifying and implementing best practices will raise donation rates markedly. The target rate set by the Breakthrough Collaborative is 75%. Benchmarks for selecting high performers were set in March 2003. Among the benchmarked high performers are Boston, Denver, Tampa, and St. Louis. A first Breakthrough Collaborative workshop was held in October 2003.
• Recommendations 14 and 15 (donation after cardiac death [DCD]): These recommendations were the focus of an End-of-Life Issues meeting held in Bethesda, Maryland, on September 25, 2003. Kathy Turrisi and Lawrence Hunsicker addressed these recommendations later in the meeting.
• Recommendation 16 (continuous quality improvement basis for certification of transplant centers and organ procurement organizations): This is part of the HHS best practices initiative.
• Recommendations 17 and 18 (initiatives to hold hospitals accountable for failure to develop policies related to donor identification as well as the failure to identify and/or refer potential donors): Terri Tye of JCAHO spoke about the recommendations during a subsequent presentation. Kress noted that he and Ascher attended a JCAHO Roundtable meeting during the previous week. It was a successful meeting, and Kress said that they were pleased with what JCAHO is doing.

Regarding recommendations 19–28, Kress noted that this is the first time that he has reported back to ACOT on their progress:

• Recommendation 19 (primacy of donor intent): The Secretary supports this recommendation. All governmental entities will work to ensure that the donor’s wishes are carried out.
• Recommendation 20 (update of the Uniform Anatomical Gift Act): Kress introduced Commissioner Connie Ring who is a Virginia Commissioner for the National Conference of Commissioners for Uniform State Laws (NCCUSL) and he will be bringing this Recommendation to the attention of the NCCUSL.
• Recommendations 19, 20, 21 (donor designation issues): Recommendation 21 involves a research component and action by UNOS/OPTN to modify the cadaveric donor registration form in order to improve data collection procedures as well as a change in terminology from “cadaveric” to “deceased donor.”
• Recommendation 22 (split livers to become national policy): The Secretary supports this recommendation but wants more research. NIH will review this matter. OPTN’s liver and intestinal committee is also investigating.
• Recommendation 23 (consensus conference to identify a single reporting mechanism for clinical outcomes): An assessment is to be completed within a month; possibly a consensus committee will be convened. Many insurance organizations have adopted the UNOS standardized request for information (RFI). A conference call is being arranged with an insurance commission organization. Turrisi and Kress will discuss this recommendation further; it appears that HHS is not yet at the point of convening a consensus conference.
• Recommendation 24 (issue a request for proposals to identify factors associated with increased risk of extrarenal graft loss): This recommendation will be dealt with as part of the research agenda.
• Recommendation 25 (list of minimum criteria called the MELD score critical level): Setting minimal criteria based on MELD alone may be premature. We need a research basis to justify this recommendation. A conference on this issue is scheduled for December 8, 2003. It is clear that HHS is moving on this recommendation.
• Recommendations 26, 27, 28 (legislative matters dealing with valuable consideration, expansion of Medicare coverage for posttransplant immunosuppressive therapy, and Medicare eligibility issues): Kress said that these recommendations are progressing within the legislative branch and executive branch agencies are necessarily quite limited in this regard. Regarding Senator Frist’s bill, Kress noted that HHS is supportive of the underlying intent behind paired exchanges, but progress is unclear despite ongoing discussions in Congress. ACOT has communicated clearly about its position, but Congress is entertaining many proposed Medicare and Medicaid changes at this time and is not taking a specific position on ACOT’s recommendation at this time. The executive branch will not weigh in while the legislative branch is addressing these issues. Kress reiterated that ACOT has advised and delivered a recommendation to the Secretary; it has fulfilled its mandate. Nevertheless, every individual has a right to contact his or her own Representative or Senator about these recommendations or any other issues.

Background of ACOT Recommendations 14 and 15
Lawrence G. Hunsicker, M.D, Ph.D.
Lawrence Hunsicker briefed the participants on a meeting convened on September 25, 2003, in Bethesda, Maryland. The topic of that meeting was end-of-life issues as they relate to ACOT’s Recommendations 14 and 15:

• Recommendation 14: That in order to ensure best practices at hospitals and organ procurement organizations, the following measure should be added to the CMS conditions of participation: Each hospital should establish, in conjunction with its OPO, policies, and procedures to manage and maximize organ retrieval from donors without a heartbeat (deceased donors after cardiac death). Such donation is often referred to as donation after cardiac death (DCD), and such donors are variously referred to as donors without a heartbeat or non-heat-beating donors. These policies and procedures will need to be developed in collaboration with the OPTN, the transplant centers, and AOPO [Association of Organ Procurement Organizations].
• Recommendation 15: That the following measure should be added to the CMS conditions of participation: Hospitals shall notify organ procurement organizations prior to withdrawal of life support to a patient, so as to determine the patient’s potential for organ donation. If it is determined that the patient is a potential donor, the OPO shall reimburse the hospital for appropriate costs related to maintaining the patient as a potential donor.

According to Hunsicker, these recommendations seem to be redundant to some extent of existing conditions of participation. Although the numbers of both living and deceased organ donors continue to grow, many patients do not have access to a living donor, and the number of traditional deceased donors (after brain death) has grown rather slowly.

Hunsicker and colleagues published a report on death audits by OPOs and concluded that, even if were possible to achieve 100% consent for organ donation from brain-dead donors, the supply of kidneys and hearts might be marginally satisfactory, but we would still have too few livers to meet the need for transplantation. This report, however, did not include analysis of the potential pool of DCDs (only after brain death). Hunsicker therefore identified the major potential for new organ donor sources as “controlled” DCDs—those who have cardiac arrests after withdrawal of life support.

DCD organs have been used for kidney, liver, pancreas, and some lung transplants. The main use has been kidney and liver transplants. There are now sufficient data to say that long-term organ function from DCDs is comparable to that of deceased donors after brain death, although there are more short-term issues (e.g., acute tubular necrosis [ATN], impaired initial transplant function) associated with transplantation of organs from DCDs. Nonetheless, DCDs are adequate donors.

Hunsicker discussed some data from UNOS (John Rosendale), which compare gross graft kidney survival from brain dead and DCD donors, and which indicate that there is no difference in graft survival at 24 months, and presumably, further out. For livers, survival is slightly lower for DCD donors, but it is quite possible that this is because DCD organs are probably used for sicker patients. Survival at 24 months is probably comparable to survival with split organs.

Virtually all potential DCDs are managed before death in intensive care units (ICUs).The ICU management of patients considered terminal continues to evolve, with a higher fraction of patients considered to be terminal. Prendergast et al. surveyed 131 ICUs at 110 institutions in 38 states in 1998. There were 6303 ICU deaths, of which 393 (6%) were brain deaths, and 2139 (38%) involved withdrawal of life support. Now, anecdotal evidence suggests that approximately 80% of all deaths in ICUs are attributable to withdrawal of life support before they die a brain death.

Organ retrieval after cardiac death following withdrawal of life support has been considered more ethically troubling in many hospitals than is donation after brain death. Progress in establishing protocols at the hospitals has been slow.

It is important for those involved to fully understand that the decision to remove life support occurred prior to the donation decision. Therefore, it takes a certain amount of modeling or walkthrough of what is involved. You have to walk through this four or five times with hospital staff to help them understand that this is a reasonable approach.

Hunsicker reviewed some data through 2002 that document a rather slow rise in numbers of organs available from deceased donors after brain death. But, there has been a rapid rise in organs available from DCD donors. Anecdotal evidence suggests that the rate is higher still in 2003.

Several transplant centers are pursuing DCD fairly aggressively; among them are the University of Wisconsin, the University of Maryland, and the University of Iowa. Yet other centers have never obtained a DCD. Hunsicker presented a chart showing deceased donors by type in five OPOs. Most OPOs that do DCD have found it useful to have a formal agreement with hospitals.

To get an idea of the potential number of DCD donors, the Iowa Donor Network, as part of its record review process in 2001 and 2002, identified patients for whom life support had been withdrawn and in whom death occurred within 60 minutes. The same exclusions used for the National Death Audit Study applied; these deaths represented otherwise apparently qualified donors. Hunsicker anticipates that nationwide a potential pool of 2500 to 3000 DCD donors exists rather than the 191 identified last year.

He went on to identify some factors that might be involved in the failure to retrieve organs. One reason is a lack of protocols for organ donation after withdrawal of life support. The fraction of retrievals from DCD donors is proportional to the number of hospitals that have protocols in place and that have worked on this procedure.

In sum:

• Deceased donors after cardiac death now constitute one of the largest potential sources of organs for transplant—a source not well documented nationally and one that appears to be very underdeveloped.
• To determine the actual potential number of these donors as well as to permit retrieval of their organs, all patients for whom life support is about to be withdrawn should be reported to the OPO before withdrawal of life support.
• Hospitals need strong encouragement to complete the development of protocols for organ donation after withdrawal of life support, including a think-through by all stakeholders of the ethical issues and current ethical consensus statements.

DISCUSSION
Barry Kahan asked if using DCD affects rates of donation following brain death. Michael Williams stated that at Johns Hopkins, they have not experienced a drop-off in brain dead donors as they have used more DCDs. Consent rates seem to be the issue, not identification of potential donors. Hunsicker spoke about Iowa’s experience. When they asked people on the street if they were willing to have their loved one stay on life support an extra day or so to allow organ donation, people were largely positive. Frank Delmonico said that in Boston, donation after brain death prevails, but they are seeing an expansion of DCD.

Ascher noted that one reason life support is being withdrawn more quickly is the shortage of ICU beds. Another issue is who gets these DCD organs. We need a model with a different distribution scheme if only the sickest patients are receiving these organs. For liver transplantation, these donors are trickier. Delmonico agreed, saying that the 20 or 25 minutes of ischemic time often precludes use of livers from DCD. Amadeo Marcos suggested that we should look not at patient survival but graft survival. We need standardized methods for procurement and maintaining the organs from these donors.

Hans Sollinger noted that it requires an enormous amount of work to convince hospitals to embark on programs to retrieve organs following cardiac death. It is important to keep the preservation time short. One barrier to DCD arises from consideration of sharing. Jim Young speculated that DCD is still tainted by the “fallout” from the “60 Minutes” television program. Administering drugs intended to preserve organ function in anticipation of organ retrieval (e.g., Regitine, heparin) could cause the surgeon to be charged with murder. The overriding factor is the lack of criminal intent or action with DCD. One participant suggested that the transplant community should urge Mike Wallace to do another program on the topic. Hans Sollinger noted that in Germany, the answer to DCD is a flat no. They are just not willing to go down this path at all. Edgar Milford asked: Ethical concerns aside, what is the status of the science of transplanting organs from DCD? Is there a hurdle to surmount to find out what the facts are? Hunsicker responded that we pretty well know the issues with respect to kidneys. There is a solid consensus in the literature about the outcomes of using these kidneys. How best to use livers and other organs is still an open question.

Report on HRSA’s End-of-Life Issues Conference
Kathy Turrisi, R.N., M.S.N.
Kathy Turrisi directed the group’s attention to the two Institute of Medicine (IOM) reports on non-heart-beating (NHB) organ donation. She asked what is stopping the implementation of DCD across the country? The list of possible reasons includes:

1. lack of clear definition about legal and ethical responsibilities because there is no clear definition of a procedure and no way to address reasonable questions
2. lack of professional and public education and understanding, and
3. financial costs.

She went on to discuss the outcomes from the End-of-Life Issues meeting. Kress, in collaboration with Subcommittee B (Recipient Concerns) drafted a list of possible recommendations for ACOT consideration that flowed from the meeting:

1. Implement all the earlier recommendations of the IOM and study any impediments that have prevented implementation so far. The principal impediment identified at the End-of-Life meeting is the fact that neither the public nor the hospitals are comfortable with the idea that life support is going to be withdrawn and some organs are going to be removed. The only way we can surmount this barrier is to be clear that DCD involves only patients who are going to be taken off of life support regardless of any potential for organ donation.
2. There should be a requirement that all Class A hospitals (and possibly Class B hospitals) begin the ethical conversation about DCD, involving both ICU professionals and ancillary caregivers. Each such hospital should be required to seriously consider the development, public promulgation, and implementation of protocols for transplantation from deceased donors after cardiac death. These protocols should focus on management in the ICU. According to Turrisi, these discussions should focus on management of ICU donors. Additionally, Class B hospitals may have DCD donors that we are missing.
3. Hold a consensus conference as a follow-up to the IOM report and recommendations. The purpose of this conference would be to develop a standard template for DCD, to generate a white paper regarding implementation, and so forth. Turrisi asked that the participants think about who should participate in a conference about what drugs can and should be used to maintain a potential donor (e.g., heparin, opiates, vasodilators) and how pronouncement of death should be carried out.
4. A Uniform Declaration of Death Protocol should be established. (This might involve brain death as well given existing inconsistencies in interpretation.) Because there are limited studies on such a protocol, research initiatives should be funded. Turrisi suggested that the American College of Critical Care Medicine Intensive Care Guidelines and Consensus could likely serve as a basis. We need to think about who should be involved in developing the standard. Such decisions are important to keep the public’s confidence in the process.
5. There should be a requirement that the OPO must be notified prior to life support being withdrawn from any patient. Turrisi recommended that such notification occur during the transition from aggressive care to comfort care. She also noted that it must be made clear who is required to contact the OPO. Safeguards must be put in place to
   (1) ensure that medical decisions are isolated from any decisions related to donation;
   ( 2) maintain complete separation between the transplant team and the patient care team; and
   (3) make certain that no discussion of donation with the family occurs prior to the family’s independent decision to withdraw support.
6. The lack of a clear definition of imminent death creates a loophole regarding timeliness of referral. There should be clear parameters regarding imminent death.
7. ACOT should endorse the current efforts of the HHS Breakthrough Collaborative toward DCD identification and referral.
8. There should be coverage/reimbursement of any additional costs occasioned by DCD protocols. Currently CMS does not reimburse the OPO for any costs until after declaration of brain death. This criterion is not relevant to DCD because the brain death criterion does not apply. For DCD, where should the break point occur—when the decision is made to transition to comfort care, when life support is withdrawn, or at some other point? Turrisi made the point that it seems appropriate to facilitate actions (e.g., instrumentation, obtaining consent for catheter placement) that meet the donor’s wishes to donate organs. This topic is not addressed in the IOM report.
9. Diagnostic costs for donor evaluation even prior to the time of consent should be covered.
10. Economic disincentives should be removed in order to promote transplantation of less-than-optimal organs. The current CMS reimbursement for the transplant experience is a disincentive to use organs from DCD and other less optimal organs, often known as marginal or expanded criteria donation (ECD). Although the long-term outcomes of using ECD organs appear favorable, the patients in whom these organs are placed experience more complications post-operatively, and thus have a more expensive hospital course of treatment.

Turrisi challenged the participants to consider which of these recommendations should move ahead with ACOT’s support. She also noted that subsequent presentations by CMS staff will help guide our discussions of these points.

Upcoming CMS Regulations and Current State of Reimbursement
Marcia Newton and Mark Horney,
Centers for Medicare & Medicaid Services
Marcia Newton provided an overview of the regulatory process. The question on everyone’s lips is: What is taking so long? In December 1999, a transplant center town hall meeting was held. The public came in to give advice. Transplant center regulation goes back years before that, however.

When analysts embark on the process of writing a regulation, they look at peer-reviewed research, IOM reports, and surveys. They attend meetings and conferences, and they call people in the transplant and OPO communities. When the analyst sits down to write a regulation, there is a large body of knowledge with which to work. A draft regulation often consists of several hundred pages. Reviewers identify unclear passages and warn of possible unintended consequences. As a result of this feedback, the regulation is modified. The Office of the General Counsel usually offers hundreds of comments. Then it goes to the Administrator who is briefed on it. He tries to reach out to providers to get their input. By the time it is signed by the Administrator, the regulation has been years in production. It then goes to HHS so that other relevant Departmental components may comment on the draft. In the case of transplant centers and OPOs, the regulation would go to HRSA or possibly NIH. CMS responds to component indications of concurrence or non-concurrence with comments.

In the case of the transplant center regulation, there has been much back and forth with HRSA. HRSA has helped CMS fine-tune large pieces of the regulation. The OPO regulation is receiving comments, to which CMS must respond. The Office of Management and Budget then has 90 days to analyze a regulation’s potential economic impact and ensure that all possibilities have been examined to accomplish what CMS needs to achieve in the least burdensome way. Then, CMS make changes in accordance with OMB’s recommendations. Some entities look at the proposed regulations multiple times.

That’s why, when it comes to regulations, CMS speaks of target dates and not definite dates. Both sets of regulations will probably be out sometime in 2004. Because of the Administrative Procedures Act, however, CMS staff cannot discuss what is in a regulation until it is finally passed.

The two regulations are proposed rules. Notice and comment rule making is usually used for regulations. The preamble to the proposed regulation’s text constitutes the largest part of the regulation in terms of volume. It addresses the paperwork burden and economic impact, but, most important, it explains the rationale behind the proposed regulation.

Once the proposed rule is released it will likely have a 30- or 60-day comment period. In the preamble, many things are not proposed because we don’t know what to propose. There may be a section on research and it may identify a problem, but ACOT can offer input if they know of data or literature that can address those gaps in the preamble.

DISCUSSION
Frank Delmonico noted that ACOT’s Recommendations 8 (methods to raise dialysis patient awareness about transplant options) and 16 (continuous quality improvement for OPOs) are pertinent to CMS. Newton said ACOT will probably see its recommendations reflected in the proposed regulations. Quality and performance improvement (QAPI) is an important part of the 2002 Conditions of Participation. Recommendation 8 will be addressed by the End-Stage Renal Disease (ESRD) working group. The ESRD/dialysis regulations have not been rewritten since 1972.

Hans Sollinger said that one way we have been able to get more organ donors is to address high-risk donors. But, transplanting organs from high-risk donors is two or three times more expensive in some cases. The length of stay is longer, and the operation is more complex. The hospitals lose money by reaching for more donors. Considering the lengthy process that Newton described, it appears that there is little opportunity to react. While these regulations are being passed around the government, transplant centers are discouraged from pushing for more donors because of financial disincentives. Newton responded by saying that CMS tries to write the regulations as broadly as possible so that they aren’t outdated quickly. Usually payment regulations are passed more quickly.

Mark Horney of CMS observed that there is only a single DRG (Diagnostic Related Group) for a transplant. He said he will take this issue back to the hospital payment staff to see if there is anything that can be done.

Turrisi asked about three different issues. First, if CMS looks at managed care contracts as we use more high-risk donors, is there some mechanism that could allow for a difference in payment based on some of those factors? A second issue that Turrisi mentioned was reimbursement of expenses for living donors. Lack of reimbursement for travel and out-of-pocket expenses is a barrier to using living donation. The third area relates to reimbursement for expenses associated with evaluating and maintaining potential donors prior to declaration of death for DCD and also inadequate reimbursements for transplanting organs from DCD, which is more expensive. She asked how ACOT can work with CMS to get to some solutions.

Newton suggested that ACOT make recommendations that relate to payment policy. If hospitals are reluctant to transplant because the DRG is insufficient, you can recommend that there should be a different DRG. Also, remember that hospitals will make more on the patient who is healthier and gets a good organ. That’s why OPOs are paid on a cost basis—a very unusual situation.

Marcos said that outlier payments occur with all types of organ transplants. Transplant centers are already being discouraged by insufficient reimbursement when organs from extended donors are transplanted. Sollinger noted that outliers in the transplantation field are a sign of good practice; this phenomenon runs counter to most medical specialties in which outliers are a sign of bad practice. Hunsicker said that these financial disincentives are at odds with sound policy and the agenda of the Secretary. Horney said that this situation is not just a transplantation issue. It would have to be taken up with the CMS hospital payment group.

Barry Kahan asked about islet cell transplantation. Horney said that there is a bill before Congress to have CMS pay for some Medicare patients who are in the NIH study. Assuming that the bill might pass in October 2004, Medicare would pay for about 30 transplants, presently considered experimental in nature.

Kress asked if ACOT only needs to ask the Secretary to make a change, or must ACOT ask Congress to make the change? Horney replied that changing the DRG should be discussed with the hospital payment group and the Secretary. One possibility might be to come up with a sub-DRG to define a high-risk donor, but CMS would need the data to back that up. Several participants said that such data are available. Hunsicker asked if it is CMS’s responsibility to look at the data, or should we be coming up with such an analysis. Horney said that ACOT would have to come to CMS or the committee that establishes Relative Based Value Units (RBVUs) for physician payments. You would then have to prove your case that the DRG is woefully underweighted. Newton said that the bottom line is that the payment for organs perhaps does not apply to the costs on the transplant side. We should identify what needs to be fixed.

Turrisi observed that many in the transplant community have records about financial implications, but we need actuarial data to show long-term versus short-term benefits. Do we request that CMS provide actuarial data to show long-term benefits to the program? Do we formally request actuarial data from CMS? What is the process by which we can get some groundwork to move the process forward? Newton suggested that ACOT representatives call them and schedule a meeting. She continued, “We can get the right people in the room. We can request that actuarial data be assembled. The best thing is to come in and talk to us. We have 4000 employees at CMS; each has a specialty.”

JCAHO Organ Donation Roundtable Initiative
Terri Tye, Director of Public Affairs
Terri Tye directs JCAHO’s public policy initiatives. She has written white papers on the nursing crisis, nationwide emergency preparedness, emergency department overcrowding, health care professional education, and, now, organ transplantation.

Tye gave an overview of the JCAHO Organ Donation Public Policy Initiative, which is a new approach to address critical issues that impact the safety and quality of health care:

• The roundtable embraces more than what the Joint Commission does—rather it comprises what multiple stakeholders can do to accomplish resolutions.
• The action plan includes the convening of an expert roundtable panel to frame issues, propose solutions, and identify accountabilities.
• A national conference is held to inform development of the white papers.
• A white paper is published.
• Proposed solutions are pursued.

To document the impact of the Public Policy Initiative, Tye offered the following statistics from the nursing shortage example:

• 300,000 copies of the white paper downloaded from the Web;
• Extensive media coverage (e.g., “Good Morning America”);
• Newspaper editorials in papers large and small across the nation;
• Appointment of NAC—a coalition to pursue recommendations; and
• Keeping the pressure on … a new paper will appear next year.

The organ donation roundtable has 36 members representing various stakeholders and interests. The roundtable was charged to frame the issues and propose solutions to address the organ shortage and issues of equity. Two meetings of the full roundtable have been held. The working title for the white paper is Health Care at the Crossroads: Strategies for Narrowing the Organ Donor Gap and Protecting Donors and Recipients. The early draft recommendations of the roundtable fall into three areas:

• Create a culture in which organ donation is a priority.
• Bring equity, fairness, and safety to the transplantation arena.
• Take alternative paths to meet the demand for organ donation.

To create a culture in which organ donation is a priority, the following draft recommendations should be implemented:

• Focus resources where there is the greatest potential to increase donation.
• Encourage hospitals to work with the OPOs.
• Establish collaborative best practices.
• Make donation a priority from the top down.
• Educate all hospital staff on organ donation.
• Create a more rigorous system of accountability using a tiered approach.
• Make organ donation performance a part of routine Quality Assurance/Performance Improvement activities.
• Develop and use consensus-based performance measures.
• Present white papers and recommendations for external, third-party review by CMS and JCAHO.
• Flesh out recommendations by roundtable.

To bring equity, fairness, and safety to the transplantation arena, the roundtable recommended conducting research to gain a better understanding of ethnic disparities in transplantation (where such disparities exist) and identify underlying causes; developing the evidence base to define other disparities, such as mental and physical disabilities; developing data sources for determining risk to living donors; and treating living donors as patients by offering clinical and psychosocial support and so forth.

To identify and embark on alternative paths to meet the demand for organs, the roundtable supports conducting demonstration projects of alternative social programs (e.g., presumed consent, mandated choice, incentive-based programs). Other ideas include supporting the enactment of the amended Uniform Anatomical Gift Act where it is not amended and encouraging donation of organs following cardiac death. Finally, the roundtable encourages reducing the demand for organ donations through prevention activities.

A national conference on organ donation is slated for March 10–12, 2004, in Washington, D.C. The objective is to reach a broad audience using a large focus on building connective cultures and partnerships between hospitals and OPOs.

DISCUSSION
Kress indicated that he will be attending that conference and urged that any ACOT members who wished to bring items to the attention of JCAHO between now and March 10 please forward the items to him for consideration.

According to Michael Williams, considering organ donation and requesting from families is a very personal and intense process. These recommendations do not seem to reflect that intimacy. Tye said that the white paper does touch on that aspect, but perhaps the personal nature of the process could be emphasized more in the second one.

Turrisi noted that involvement of other accreditation bodies would be important, too. She asked about how to stimulate such involvement.

Turrisi said we need consensus-based metrics. Tye cited the example of how in 2002 JCAHO declared nosocomial infections to be sentinel events, but no reports were received. There must be an accountability system in place. JCAHO wants to promote HRSA’s best practices. Ascher asked if a draft of the second white paper could be circulated, and Tye said she would be happy to share it.

OPTN Compliance Policy
Mary D. Ellison, Ph.D., MSHA, Assistant Executive Director for Federal Affairs, United Network for Organ Sharing
Mary Ellison is assistant professor of anatomy at the Medical College of Virginia and project director of the OPTN contract. She was invited to speak at the behest of Subcommittee C (Public Concerns).

OPTN uses survey instruments, a peer review process, and data systems to conduct ongoing and periodic review of each transplant center and to ensure compliance. Compliance monitoring occurs through desk audits, organ center review of audiotapes, compliance review of every allocation, potential transplant recipient (PTR) analysis by staff and the Membership and Professional Standards Committee (MPSC). Inquiries are initiated if allocation occurs out of order. Staff analyzes refusal codes, inactive programs, and so forth. They also check across the database and perform computerized cross-checks. The staff act on member self-reports to justify allocations and fiscal reporting.

Field audits are carried out at each heart and liver program at least every three years and at every OPO every three years. During these onsite reviews, patient medical records are reviewed for urgent status listing, samples of other listing, data submission, and completeness. Other checks include verification of donor information and confirmation that organ packaging, donor maintenance, and pertinent donor testing are carried out pursuant to policy. Also, data submission history and completeness are checked.

Policy enforcement is based on peer review and due process to ensure compliance and establish a formal process of hearings. The rationale behind medical peer review ensures quality patient care by leveraging peer pressure. The focus is to bring members back into voluntary compliance. Secondarily, the focus relies upon sanctions to achieve policy compliance with applicable standards or policies. Sanctions may also be appropriate as punishment for severe infractions even if the facility immediately returns to compliance.

Confidentiality of pre-decisional matters is essential for member and peer participation. Confidentiality of medical peer review is ensured to the extent permitted by law.

Possible sanctions include letters of warning, admonition, reprimand, and additional site visits at the member’s expense. Potential adverse actions include probation, designation as a member not in good standing, patient notification, Commission notification, and legal and business risks entailed by failure to meet medical standards while out of compliance.

Ellison described outcomes of compliance review activity between October 2000 and September 2003, which she described as a “good-news message, by and large”:

• National averages of compliance scores for liver transplant centers:
  Administrative compliance 91%
  Clinical compliance 97%
  MELD/PELD clinical compliance 96%
• National averages of compliance scores for heart transplant centers:
  Administrative compliance 92%
  Clinical compliance 97%

Altogether, the OPTN has carried out 201 reviews of liver and heart programs. Some programs have been audited several times. Some have been referred for possible adverse action. Sixteen programs have been referred to MPSC, five with ongoing monitoring. Eight OPOs have been referred; seven are active with ongoing monitoring. All MPSC-referred programs submitted corrective action plans and are complying with ongoing monitoring. One program has been referred to the OPTN/UNOS board of directors for confidential probation. That program has made good progress with its corrective action plan but remains on probation, but another violation will result in public probation.

These are the results of the MPSC referrals:

• 1 hospital restructured its medical records department
• 2 programs requested policy in–service training
• 1 OPO attended AOPO training
• 2 programs voluntarily inactivated
• 2 programs restructured.

DISCUSSION
Barry Kahan said that he had heard that some programs had been referred to the Office of the Inspector General (OIG), which instituted fines. What is the best way to handle violations? Often the offender is not a single person; rather, it is a whole structure. Maybe there should be a teaching module that could represent a holistic, therapeutic approach for the entire institution. Kahan asked if such a module could be made available on demand.

Ellison said that sometimes it is one person, sometimes it is more than that. It’s a mentality that a program must adopt. Sometimes OPTN asks certain members to hire consultants from similar institutions with good policy compliance.

Some discussion occurred about the University of Illinois case. Ellison said that the Illinois case occurred before the institution of this program. Kahan asked if we are sure now that all centers and OPOs know they can go to UNOS/OPTN with problems. Ellison asserted that the 3-year cycle for site visits and reviews should make people familiar with UNOS/OPTN’s compliance function, which is intended to be quite public.

Williams asked if there is a values-based side to compliance; what is the improvement that is coming out of compliance? Ellison said that finding 96%–98% compliance with the first round of inspections is very encouraging. Generally, the community has operated within policy even before a compliance department was set up. With regard to process improvement, this is coming to OPTN. OPTN has just created the Operations Committee, which grew out of the Duke incident. The thought was that it’s not a person problem; rather, it’s a system and a process problem. The Operations Committee looks at the organ placement process and how to improve it.

Kahan asked if there has been a survey to address public distrust. Kress said that Subcommittee C has taken this issue up because there is scant information on the topic.

Paige Cottingham-Streater queried about possible consequences in terms of effects on the patient community. Ellison replied that there has not yet been a case where UNOS has made patient notification an adverse action. There are requirements of the member institution that it needs to care for its patients. The question is which situation serves the patient least: being listed at a facility that is out of compliance and resistant to becoming compliant, or having the inconvenience of being required to list at other centers? That dilemma is the reason why patient notification actions are a last resort.

Milford agreed that the real goal is to make sure that patients get transplanted. He asked if Ellison has thought about indices that could indicate improving patient care and well being. Ellison responded that they are identifying metrics that can be applied to the database; they could build programs that could identify the top 10 metrics on a regular basis. They are thinking about how to operationalize the results of such analyses.

Flora Solarz recalled that sometime around 1994 a center did have to close. We need to ensure that other centers would accept a closed center’s patients and transfer the patients’ waiting times.

Return-to-Work Programs
Joanne C. Ball, M.S.T., C.V.E., A.B.V.E.
Joanne Ball described Vanderbilt University’s Return-to-Work Program. Unemployment nationally among transplant patients is 62%. The human costs of posttransplant unemployment include:

• Incomplete recovery process
• Sick role reinforced
• Damaged self-confidence
• Disruption of family and social structure
• Financial problems.

Posttransplant Social Security Disability costs run about $10,800 per patient. The median return-to-work time is 3.5 years. Each 100 patients served by vocational services can save more than $1 million if we can get them back to work a year earlier.

In 2002, 152 patients were referred to Vanderbilt’s Return-to-Work Program, and 60 were served. Forty-two patients returned to work or entered state-sponsored vocational training or college. The average wage was $12 per hour.

The Vanderbilt program is funded through a grant from Tennessee Rehabilitation Services. Vocational rehabilitation is provided onsite. In other states it has not been possible to set up this sort of an arrangement because few and scant funding sources are available.

At Vanderbilt, a vocational specialist is part of the transplant team. Vocational specialists may be credentialed as a Certified Vocational Evaluation (CVE) specialist or a Certified Rehabilitation Counselor (CRC).

By taking a proactive, team approach, the expectation that the patient will return to work is introduced prior to transplantation. Rehabilitation services commence as soon as a patient is able. The longer a person is out of work due to illness or injury, the lower the chance that he or she will ever return to work. Medical and vocational rehabilitation can be coordinated with a team approach. It is a simple matter to check with a patient’s physician about the suitability of particular jobs.

What are the barriers to transplant patients who anticipate a return to the workplace? Patients may be concerned about diminished functioning and loss of disability benefits. They may also fear employer discrimination.

The vocational specialist may be able to help patients arrange job accommodations with previous employers if they have maintained a relationship with the employer. Other possibilities include new employment or retraining. The vocational specialist may serve as an advocate for the patient, offer information and referral services, provide vocational testing and career counseling, or help with the job search and placement.

Most patients are concerned about losing their Social Security benefits. Negotiating the system can be complicated, but Social Security does have a return-to-work provision. Vocational specialists can help patients tap into such resources as:

• State vocational rehabilitation
• Ticket-to-work program
• Social Security disability employment supports
• HIPAA (prohibits discrimination in employer health insurance because of disability or preexisting condition)
• American with Disabilities Act (ADA) technical assistance.

In addition, the Work Opportunities Tax Credit provides a benefit of up to $2400 for for-profit employers.

After transplant, the return to work starts with vocational evaluation, which consists of aptitude testing, hands-on evaluation, and computer testing. The physician provides information to identify work restrictions and whether those limitations are permanent or temporary.

A variety of assessment tools are used to identify the patient’s interests and aptitudes. The Department of Labor has profiled thousands of jobs based on aptitudes to match people with jobs. The Department also recognizes five different levels of exertion. Vocational specialists must know the local labor market and training opportunities in order to help the patient make a career decision and develop a plan of action.

Job search training for transplant patients is very similar to the training that might be undertaken by anyone looking for a job. Disability disclosure is a big issue with transplant recipients. The vocational specialist also explains how ADA issues might affect the patient as a job seeker and new employee.

Regarding job placement, the specialist can provide job leads; contact employers on a patient’s behalf; offer counseling and support during the job search; and provide job retention services. The specialist follows the patients and intervenes to help them succeed.

In terms of career retraining, Vanderbilt’s Return-to-Work Program’s relationship with Tennessee employment services gives patients opportunities otherwise unavailable to them.

Vanderbilt has developed a patient satisfaction survey and has validated it. Several vocational questions are included. The survey was the basis for a study that compared quality of life (QOL) for post-liver transplant patients who were

1. unemployed,
2. optimally employed, or
3. sub-optimally employed.

Optimal employment was defined as being employed continuously during the first three years posttransplant, earning a wage of at least 75% of pre-illness wage, and being satisfied with the current job. The study showed that optimal employment following liver transplantation is associated with higher quality of life. Lower QOL is associated with suboptimal employment and unemployment. The study strongly supports the mission of Vanderbilt’s program and shows that it is not enough to have a job; job satisfaction is an important component.

The survey is also administered pre-transplant, but Ball was not sure if it was at the time of wait listing or at some other point.

DISCUSSION
Turrisi suggested that it would be useful to begin vocational evaluation while patients are still on dialysis. Dialysis patients may have been out of work for many years. She expressed interest in reviewing all aspects of the survey instrument because it may be useful for evaluating overall QOL for transplant recipients.

Flora Solarz emphasized how employment symbolizes a transition back to life for organ recipients. Some recipients do choose to stay at home, but it really brings patients a sense of value and a feeling that they are making a contribution to the world. She asked if Vanderbilt looked at long-term survival of those who return to work versus those who did not. Ball said that she suspects that those who return to work do live longer but the numbers are probably too small for statistical validity.

Roger Evans said that organ recipients are sometimes denied employment because employers do not want their insurance rates to rise. If a recipient requires accommodation under ADA, he or she does not have to inform the potential employer. Ball agreed that small employers are more likely to turn recipients down; there is more opportunity with large employers who have a larger risk pool and, therefore, are less affected by having some employees who make greater demands on the insurance carrier.

Another View on Increasing Organ Donation
Luis Tomatis, M.D., FACS, FACC
Luis Tomatis described a proposal of Richard M. DeVos that may increase organ donation through deceased organ donation incentives. This proposal builds on an idea originally developed by businessman Gene Epstein and veterinarian Al Boessman, both activists in the organ donation movement. The proposal does not alter the present UNOS allocation process. Rather, it would establish a premium-free insurance-like policy or tax credit that would be paid to the designated beneficiary of any person who agrees to eventually donate his or her organs should they become brain dead through an accident or illness.

To reassure patients that all available critical care will be used to keep them alive, no one will know if the patient is a donor.

The key features of this proposal include these:

• The permission is given by the donor, transferring the decision from the family to the true donor.
• Such incentives are likely to dramatically increase the number of organs available for transplant.
• The program would net large savings for the present payers.
• The program would empower the poor by allowing them to bequeath compensation to their families.

The incentives would be paid by insurers, who will realize significant savings.
For kidney transplants alone, each patient taken off the waitlist saves between $200,000 and $400,000 over the 10.2 years of average survival of kidney recipients. That translates to $400,000 to $800,000 saved per deceased donor.

How much compensation would be appropriate? Tomatis suggested that a $10,000 incentive would be significant enough to motivate signing. Compensation would be viewed as recognition by society in appreciation for the donor’s priceless gifts of life to unknown others. The compensation would be the donor’s final gift to their loved ones.

According to Tomatis, Dr. Sam Gregg, an ethicist with the Action Institute for the Study of Religion and Liberty asserts that such incentives would be ethically and morally acceptable. Commodification is an accepted practice in our society: for example, death benefits paid by the armed forces and public service; insurance coverage for loss of different limbs and so forth; tort law; and some examples in transplantation.

Tomatis played devil’s advocate by raising some arguments against such a plan: For example, some might argue that people might be offended by an offer of money for organs when they have just suffered a loss that cannot be compensated for. This argument does not apply because the decision is made before death. When the deceased’s will is known, families almost always give consent for donation.

Another argument might be that such a program would decrease overall donations because people would not give away what they can sell. This argument may apply to living donors, but not deceased. In countries where buying organs from living donors is legal (e.g., Kuwait, Iran), experience shows that the number of deceased donations increased radically when the sale of organs was legalized.

Others might argue that such a system offers potential for abuse. Tomatis disagrees. In the United States, for example, 149 million people have some form of life insurance, and despite that prevalence, abuse is rare.

Tomatis said that it cannot be argued that the proposed program would prey on the poor. It would actually empower the poor by allowing them to provide for their families after their deaths.

The argument that this program would start us on the slippery slope to compensate living donors is also invalid, according to Tomatis. This proposal could double the number of deceased donors, thereby alleviating pressure to compensate living donors and maintaining the altruistic nature of living donation.

In conclusion, Tomatis stated that only a trial of financial incentives will answer all the questions. An Internet search shows hundreds of articles on financial incentives for donation. Society is ready to learn more.

DISCUSSION
Kahan asked how a pilot program would be funded. Half the monies would be going to families who would donate without any sort of compensation. We have to weigh in the cost of the entire program. Tomatis responded that the government should fund the pilot studies; eventually insurers would bear the cost in anticipation of the savings they would net by having more patients receive transplants.

Tomatis said that his hospital is second in the nation in consent rates. Still some 30% are lost. When the family must deal with a decision about donation while their loved one is dying, it is just the wrong time to ask.

Solarz asked about what happens if the organs cannot be used. Tomatis said the benefit would be paid only if the organs are transplanted.

Public Comment
Mr. and Mrs. Nadel proposed “a simple adjustment to the organ donation rules that would likely alleviate...problems with the current system by inducing many more commitments to donate and deterring families from challenging donors’ wishes. Instead of asking individuals to act purely altruistically, those who commit to donate organs (at death) should be recognized with an increased chance of receiving an organ should they later need one....Donors’ commitments would effectively represent organ insurance, not unlike the former ‘family credit’ blood donor systems, whereby a blood donor’s contribution serves to cover his or her family’s annual blood needs.”

Vickie Hurwitz commended ACOT on its provisions for protecting living donors. She is the widow of Mike Hurwitz who died three days after donating part of his liver to his brother. She is strongly behind the movement to set up a retroactive registry for organ donors: “There has been much made about informed consent, but you can’t inform if you don’t have data. Someone considering living donation would not find information about 75% of deaths. Some 16% of live donors cannot get insurance. Families are also deeply affected by the decision for living organ donation.” Hurwitz also recommended setting minimum standards of health for donors as a best practice. “There has been much discussion about deceased donors, but living donation is also a family matter,” she said.

SUBCOMMITTEES B AND C BREAKOUT DISCUSSION

Recipient Concerns and Public Concerns
With a Focus on End-of-Life Issues
Kathy Turrisi, R.N., M.S.N., and Roger Evans, Ph.D.
Turrisi opened by inviting the group to discuss some of the recommendations that flowed from the End-of-Life Issues meeting held on September 25, 2003. Hunsicker gave a quick overview. Donation after cardiac death (DCD) was what we started with in donation; donation after brain death donors was secondary at that point.

After the unfavorable coverage of DCD by Mike Wallace, the transplant community strove to legitimize the process. To evaluate DCD, a committee was convened that included no one from the transplant community. There were areas of malaise. For example, it was not clear when people become dead after withdrawal of life support. Rather arbitrarily, the IOM suggested a 5-minute minimum interval between cessation of cardiac activity and declaration of death. At the same time patients were being put on Regitine to prevent vasospasm prior to death. Other considerations include catheterization prior to declaration of death. IOM said that such measures are legitimate but recommended that standards be set.

Turrisi said that the transplant community fears adverse community reaction, and there is also concern about hospital staff discomfort with the process. How can we help them get past their discomfort with the process? Is it a matter of standard protocols—having a discussion and putting policies in place? The opinions of the transplant surgeons hold great sway and affect hospital staff attitudes. Marcos stated that his center may be one of the leaders in bringing in organs from other OPOs. Sometimes, local programs do not want to get involved in DCD. Hunsicker said that his center uses the organs locally because they have no problems using them locally. Some organs are sent to other centers.

Hunsicker suggested three areas that need to be addressed:

• Transplant doctors themselves need further education and need to understand that we have an obligation to participate in the retrieval of these organs.
• Hospitals need motivation to address this issue. The scenario will arise where a hospital has an opportunity for DCD but does not know how to proceed. Such motivation could occur through conditions of participation or through JCAHO.
• The OPOs need to be motivated (possibly through CMS).
• The whole issue should be based upon a standard supported by the neuroscience and ICU communities.

Marcos said that, for livers, if we are not giving heparin and so forth to the potential donor prior to the declaration of death, transplant outcomes may be poor. The protocol must go hand in hand with outcome data. Once the neuroscience and transplant communities arrive at some standards, they must be communicated to the hospitals.

Hunsicker pointed out that we have an excellent model in the IOM committee who consulted the transplant community but had no members from the transplant community. The final promulgation should come from an outside group.

Milford asked how the DCD donor is fundamentally different from the brain dead donor. Why do we have to go through a different set of considerations? That is how we should address this situation. What are the issues of departure? Another participant agreed: It is hard to say what is different about neurological determination of death. He recalled that the American College of Cardiology, AHA, and others held a conference to determine who should be transplanted and so forth, and came up with a white paper that led to a consensus conference and was adopted nationwide. We should follow a similar process to develop a working document to send to ACOT, OPOs, hospitals, JCAHO, and other relevant entities to provide a framework from which to start. Otherwise it might be years to come to consensus. Turrisi reminded the participants that the guidelines of the Critical Care group had been discussed as a possible model.

Michael Williams suggested setting boundaries about what is legally and ethically permissible in terms of practice. If one builds on the model of brain death, there are parallels to DCD. It is then a matter of how best to manage the patient to optimize potential for donation. Should one offer it to all families under appropriate circumstances? If we have to wait for evaluation by the OPO, how long is it reasonable to wait? Once the decision to donate is made, certain therapies will be employed to maintain the patient. There are different steps along the way. Each group must contribute its expertise to each step of the protocol.

Several people objected to the notion of excluding the transplant community from the process. If we don’t have any agreement in the community, we will not progress.

Henry Krakauer said the impression is that the critical difference is that the process of procurement begins before death for DCD. Hunsicker said that evaluation begins before death, but not the process of procurement. The withdrawal of life support is the critical issue. In the case of a brain dead donor, the patient becomes dead on his own. Nothing is done to hasten that death. In the case of DCD, the patient dies because of an intervention—the withdrawal of life support, typically by the patient’s anesthesiologist, and typically at the family’s request, and typically before any conversation about possible donation has occurred. The intervention is not directed toward donation. It is done as part of the management of that patient. It is the close approximation of these two steps that gives people problems.

Williams walked the group through an example: A patient is in the ICU after a profound injury. It becomes clear to the treating team that the patient is unlikely to recover to a point of health. The family or an advance directive says that care is to discontinue. That is a conversation we are used to. Then some families ask about the possibility of organ donation. Historically, this option has been family-driven. If you want to offer this option, life support must continue for a short time.

The decision to withdraw life support must be made first. If you are going to offer the opportunity for organ donation, you want to know if the patient is medically suitable for donation before the offer is made. How do you meet these two goals at the same time? Certain therapies must be continued during the evaluation phase.

The withdrawal of the life-sustaining intervention occurs in the OR. It is necessary to wait a suitable time (usually 5 to 10 minutes) to ensure that autoresuscitation will not occur. There may not, however, be a total cessation of brain activity. The person who declares death is not permitted to be a member of the transplant team. After declaration, the families have a short time with the patient.

It is difficult to predict ischemic time. If it goes too long, the organs are not usable. Kidneys and livers can tolerate some warm ischemic time. The heart and lungs cannot. To maximize the potential for donating these organs, certain therapies—catheterization, drugs—are given to maximize potential for donation prior to the declaration of death. This is where ethical arguments arise and where different people have different comfort levels. We should list these questions and address them head-on. Turrisi noted that the IOM report recommends local discretion.

One participant suggested not procuring lungs and livers through DCD as a way of avoiding this controversy. For example, Williams said, if the heart can be restarted, then it could have been restarted in the patient, counter to the definition of a non-heart-beating donor (NHBD). Someone else asked if it is reasonable in the global milieu of these patients that spontaneous resuscitation could occur. The answer offered by several was no, that is, spontaneous resuscitation is a phenomenon that has been written about and hypothesized, but one that no practitioner present had ever witnessed or indeed knew of occurring.

Another important difference between donation after brain death and DCD is that for most patients in the ICU a do-not-resuscitate (DNR) order already is in place at the request of the patient or the family.

Son-ja Robet said that with the minority community, the fear is they are not going to be treated.

Hunsicker said that this discussion has recapitulated and clarified the issue, but we have not come to a phraseology that shows that we have some agreement here. We are not constituted to do this. Making a decision about when and how death should be declared is a topic that is outside the purview of this group. He said that the transplant community should offer opinions so that people can consider them in the context of a consensus conference or standards or protocol de-velopment, but someone else should make the decision. However, we should identify the group(s) who should undertake this job. These policies are not going to arise spontaneously in OPOs and hospitals. We have to make them happen.

Another participant endorsed Hunsicker’s words: There is public confusion around even brain death. That too needs consensus. We will only escalate misperceptions if we—as a body—seem confused. We need some boilerplate text from which to start. We need a fundamental working document (template) from which to begin. We can offer some parameters and list questions that must be addressed.

Kress suggested that rather than look at disagreement, we should identify what we do agree with and build upon that toward consensus. First, we want all hospitals to have this discussion even though they may come to very different conclusions. Many just avoid it altogether. We could put protocols out there to use as paradigms. There must be a wall between the treating team and the transplant team. We should have CMS monitor this barrier. Distrust can be defused that way.

There was some discussion about developing templates that hospitals could use to develop protocols for handling DCD. Insofar as a template, the IOM has done a great deal of work already. Best practices within OPOs have been offered. A template based on consensus would help move the discussion forward.

Others opined that we may not be able to get consensus; we may have to proceed without consensus. Some physicians will be at odds with the majority opinion. They will continue to raise issues that will put this practice into question. Nevertheless, we must give the hospitals and OPOs something with which to work. They will want to know about others’ experience.

Williams suggested taking a values-based approach versus a compliance-based approach. The second IOM report showed that this is a new approach to end-of-life care. Some institutions are willing to do it and others are not based on their values. We want an approach that doesn’t force people to do this but will lead them forward. For example, Johns Hopkins asked for Pittsburgh’s policy and adapted it to their needs.

Hunsicker recalled that one recommendation that came out of the End-of-Life Issues meeting is making such a discussion a condition of participation. Williams said that such a recommendation does not have much “punch” behind it. Hospital administrators will just say, “We discussed it and we say no.”

There was some discussion about the Breakthrough Collaborative. Some wheels may be turning already at hospitals which participated in the Collaborative. The Collaborative has already garnered high-level buy-in.

Williams said that the recommendation about standards for the declaration of death is a call for research. For example, what is the minimum amount of time to wait? For declaration of brain death, the Harvard criteria require 6 hours between evaluations. How often does autoresuscitation occur? How long is too long a warm ischemic time?

Hunsicker suggested that if the Breakthrough Collaborative is making headway, we could scrap the idea about conditions of participation. We just need some trigger for the evaluation and referral process because the earlier the OPO is involved, the better the chance of getting an organ. Turrisi said that we need a definition of imminent death. Without a concise definition, hospitals have “wiggle room.” So long as they make the call to the OPO, they have met the requirement. How do we set a timeframe for notifying the OPO before withdrawal of life support? How can ACOT assist this process?

Another participant asked if we can move this process forward through reimbursement. CMS has basically signed on. The negotiation of the exact phraseology as to when they will start reimbursement is complex, too much so for a group of this size.

One participant suggested this wording for a recommendation: ACOT strongly endorses the desirability of spreading awareness of DCD issues through the Breakthrough Collaborative and other entities to bring this practice to the attention of hospitals.

There was disagreement among the subcommittee members about whether ACOT should undertake developing a template to aid hospitals as they develop DCD protocols. Several recommended convening a consensus conference to develop a template to see who is eligible for DCD and at what point death should be declared. We could recommend who should sit at the table. That is an identifiable, objective way for us to proceed. Hunsicker further suggested that ACOT could evaluate where there is a lack of information that needs further research.

Milford revisited the topic of what is stopping the usage of DCD across the country. The reasons appear to be related to: (1) finances; (2) lack of clearly stated legal and ethical responsibilities because of the lack of clear definition of a procedure and no way to address reasonable questions; and (3) lack of a mechanism for educating the public and dealing with questions in a way that can be understood and people can be comfortable with this process.

Turrisi said that it sounds like what we need is a consensus conference to generate a white paper and a template. The plan would be similar to what we did with informed consent. Another participant said that these tasks are addressed by NIH consensus conferences. The NIH is probably a better place to do this.

Hunsicker offered his version of what the group seems to have agreed upon: (1) We need to have a coming together of the communities through a consensus conference as part of the NIH research agenda; (2) We should endorse current efforts of the Breakthrough Collaborative toward DCD identification and referral; and (3) CMS and other payers must address reimbursement issues that presently are barriers to DCD donation.

Kress suggested that the recommendation might be phrased in terms of NIH doing the research component.

Roger Evans noted that many of these items would be dealt with by the organizing committee for the consensus conference. It is not necessary for ACOT to get bogged down in the minutiae. Kress said that we have at least three different components of HHS that will be looking at this. We should raise some specific issues.

Another participant said that ethical and legal concerns must also be considered. Palliative care must not be ignored either. We also need to think about what happens if the patient does not die. We need to include members of the public and faith communities who would be involved in these issues.

Mary Ganikos reminded the group that in addition to the Collaborative that there are grant programs available.

Turrisi asked that the participants please continue the discussions via the e-mail list service. We want to get all these good ideas down on paper.

FRIDAY NOVEMBER 7, 2003

Update on Recommendation #10 for Medical Examiners
Mike Seely, Pacific Northwest Transplant Bank
On September 9, 2003, Mike Seely met with an ad hoc committee of medical examiners in San Jose, California. He attended as a representative of ACOT in regard to Recommendation 10:

That legislative strategies be adopted that will encourage medical examiners and coroners not to withhold lifesaving organs and tissues from qualified organ procurement organizations.

“Every organ, every time” was the motto at a recent meeting of the National Association of Medical Examiners (NAME). The goal of the ad hoc committee is “zero denials.” ACOT’s recommendation is an opportunity for the procurement community to bridge to the organization in a different way—a collaborative effort among the procurement entities to be at the table with this ad hoc committee as it develops its policy statement. The policy at present reflects only the medical examiners’ position, but the problem encompasses more than just medical examiners; coroners, district attorneys, and pathologists are involved. Just looking to NAME is not enough; we need to incorporate these other groups as well. NAME is wary of any prescriptive legislation but we have an opportunity to connect to this group. They think we can get to zero denials. Our recommendation is strongly stated and is helpful in that way. Seely said he will have a chance to review the minutes from the ad hoc committee.

California recently passed a coroner’s law modification of UAGA that parallels the recommendation that a coroner or medical examiner must be present to make the denial. The law should be in place in 2006. Texas has this legislation. New Jersey also has similar legislation.

DISCUSSION
Kress said the next step is implementation. The goal of Recommendation 10 is to get to zero denials. HHS has been having the Secretary’s Office of Intergovernmental Affairs set up more communications with other groups, such as NAME.

Kress asked Phil Berry if we can move ahead without legislation rather than using legislation as the hammer. Berry said that legislation will probably be necessary as an impetus. Seely agreed that legislation is a platform. He emphasized, though, the importance of relationships and communication to ensure that legislation does not become a polarizing force. Berry said it is better not to view legislation as a hammer. Getting legislation passed was a “slam-dunk” in Texas, but it may not be so easy in other places.

Kress agreed with trying to continue to rely on the relationships Seely has established to try to move to other organizations of coroners, district attorneys, and others.

Howard Nathan said that in many states coroners have no bases in pathology and so forth for making these decisions. Pennsylvania, for example, has a coroner system. He said that relationships are not always enough; sometimes you need a piece of paper to wave. He estimated that some 500 to 600 organs are lost each year because of action (or inaction) of medical examiners or coroners. He said that the Uniform Commission on State Laws may want to consider this problem, but if this is really important, we have to take action.

Seely summarized, saying we need to approach the other groups and we need a platform of legislation.

Jim Young agreed: “It is important to have across the country these legislative efforts. Many organs are likely lost because the director of the OPO can’t reach the person in charge. It is probably the non-MD people who are making bad decisions.”

Kress warned that “everyone wants legislation for the other guy and not for themselves. It’s the real world. They probably want to be cooperative, but they don’t want to be under the legislative hammer.”

SUBCOMMITTEE BREAKOUT SESSION REPORTS

Report and Recommendations of Subcommittee D
(Allocation Concerns)
Hans Sollinger, M.D., Ph.D.
Reducing Organ Wastage
There is more organ wastage in the United States than in Europe, although there is little wastage where livers are concerned. There was a seed of a thought that there are areas where this could be improved with standardization. Many members thought the frequency of cardiac donation varies with the comings and goings of staff that have this particular interest. That topic will be the subject of more discussion to see how we can statistically approach that issue.

Recommendation:

• Biopsies have been used to determine if a kidney can be used and to predict posttransplant function. One small study has been published. Also, an Italian paper showed that pre-transplant biopsy is not a predictor of kidney function. Personal experience has shown that we have all seen unfavorable-looking biopsies on kidneys that function fine posttransplant.
• As there are no comprehensive data correlating posttransplant function with outcomes the subcommittees recommend prospective multi-center trials aiming at better defining the predictive value of pre-transplant biopsies.
• The potential value of this trial is to identify more kidneys that can be used for transplantation.
• The subcommittee recommends the formation of a core trial group to participate in the design of a trial and to help write the initial proposal. This group will participate in a workshop in December in Washington. After the workshop, a proposal will be forwarded to the Interventional Clinical Trials Grant program.

There was some discussion about the feasibility of carrying out such a trial; whether surgeons would transplant organs in “blind” fashion, not knowing the results of the biopsy prior to surgery.

Motion to adopt; seconded and passed by voice vote. (Note that all such votes were subject to the usual ACOT procedures of subsequent wordsmithing and modification by email correspondence after the meeting.)

Nondirected Donors

• Recommendation: The nondirected donor should not be able to make any requests regarding the identity [or characteristics] of the potential recipient. We need very clear guidelines.

This recommendation stimulated a great deal of discussion, with opposition being expressed by Ascher, among others, who made that point that many people who wish to be nondirected donors feel a relationship with the center and want to stipulate, for example, that their organ go to a child. Others agreed with the sentiment voiced by Harmon who maintained that the principle behind the recommendation should override. Otherwise donors could make all sorts of demands on the basis of race and other inappropriate criteria. There are many pediatric-only programs. Donors could go there if they want their organs to go to children. Delmonico suggested that nondiscriminatory language could be drafted to ensure that a donor does not try to direct donation to a certain category of recipient.

Gail Agrawal said that she initially supported this recommendation because she was thinking that some donors might try to stipulate that their organs not be given to certain races or prisoners, and so forth. In light of the subsequent discussion, she asked if the recommendation could be refined so that certain types of donor directions might be honored. She asked that the subcommittee consider that possibility.

Motion to adopt; seconded; passed by voice vote. Subsequent discussion, however, indicated a withdrawal of support for this as a recommendation and an agreement that the item would become an agenda item for ACOT’s next meeting.

• Recommendation: The recipient of a nondirected donated organ should be selected from the smallest possible pool according to appropriate guidelines (e.g., transplant center, as opposed to the region, OPO).

Most committee members felt for practical reasons that the smallest possible pool should be selected. The community may wish to reevaluate the effects of this recommendation in a few years. We have very little experience with nondirected donors thus far.

Others raised concerns about how to handle nondirected donors who become interested in donating in response to campaigns by OPOs and the Federal government. In these instances, it makes sense to see where the patient at the top of the list is. Each locale must have a process whereby the transplant centers come together as to how they will handle these requests. Up to now, people have been satisfied with this system.

Marcos said that the decision is up to the donor. If the person goes to the OPO, the OPO should be the pool. If such donors go to the transplant center, the center should be the pool. Harmon concurred: We are giving the patient the choice as to where to go. That trumps everything. We can provide them a choice as to which hospitals they could go to. They often choose one that is close by. They can pick the institution where they want to have their operation.

Solarz said that this is not just a discussion of hospitals and OPOs. It is about people on a waitlist in some locality. It is a community of patients waiting.

Delmonico said there are other considerations, too. We could send questionnaires to interested individuals about their health and background information to see if they are appropriate for non-directed donation.

Sollinger said that the discussion had pointed out many complexities not yet considered by the subcommittees. They need to work more and develop a more mature proposal. This topic will be addressed more fully during subsequent telephone conferences.

Kress asked about the intent behind these recommendations. Is the second recommendation an administrative decision? He also said that it is clear that ACOT is trying to get ahead of the curve on some of these issues. It appears, however, that some issues are not ripe to be stated as formal recommendations yet. He asked the membership to send in their thoughts and any protocols available from various jurisdictions.

Ascher said that at her center they honor living donor requests. Often donors wish to give their left lateral segment for a child. Hunsicker said that the concern is that once we have carved out one exception that more will follow. He acknowledged that Ascher put a new spin on this issue. Part of the process is to explain that there are two procedures that carry different risks. We could tailor the first recommendation to reflect these two different procedures.

Delmonico said that individuals want to donate to children. Assuming that there are no psycho-social issues with the donor, how can we deny that possibility to the donor? Harmon said that it is a slippery slope. Some people want to stipulate that their donation go to a young child, not a teenager. He suggested that we could rely on nondiscriminatory language to ensure that a donor does not try to direct donation to a certain category of recipient.

Kress observed that the group seems to be pulling back from recommendations related to nondirected donors; we seem far from consensus around these. He volunteered to draft some language and circulate for further discussion.

Sollinger asked if it is always necessary to have full agreement around the recommendations. Kress said that, until now, ACOT has always achieved consensus. He ventured that full agreement is not absolutely necessary, but there seems to be major dissension and concerns around these two recommendations. These recommendations may be premature.

Report and Recommendations of Subcommittee A
(Organ Supply Concerns)
Gail Agrawal, J.D., M.P.H.

• Collect and analyze additional data to determine if patients are being placed on organ wait-lists (especially for kidney) inappropriately; that is, to address the question of whether people on the waitlist are good candidates for transplant. The relevant questions are: Why are patients dying on the waitlist? Why do patients die within 3 or 6 months post-transplant? Should they have been on the list at all? SRTR has provided some data but these questions were not fully answered.

Hunsicker noted that this recommendation is akin to another issue raised in another venue about the nature of the list. One relevant question is: How many patients are “ghost” patients who are really too sick to receive a transplant? Young said we need to achieve the best outcomes for a scarce resource. We need to be doing a better job of identifying those who are no longer viable candidates. Turrisi suggested we need some sort of refusal code changes to see why people are not candidates when they present at the transplant center.

Hunsicker asked if we can predict who is going to die and whether the intervention of a transplant changes that risk. How does intervention change the outcome? There are data to answer these questions. The Scientific Registry of Transplant Recipients (SRTR) has been focusing on this question for a year and a half. We need to know:

• Are we allocating properly?
• Are we listing appropriately?
• How can we measure equity in allocation?
• How do we get people on the list in the first place?

Hunsicker said that what came out of a meeting on allocation policy formulation was that each list needs some way of ensuring equitable allocation. MELD/PELD scores have largely answered the question for livers. A second area of concern is how we are going to use duration on the waitlist as a basis for allocation. The major area for potential inequity has to do with getting onto the waitlist in the first place. JCAHO is also concerned with this topic.

At least three subcommittees are interested in the waitlist. Even if we maximize donor potential we will not be able to reckon with the ever-expanding wait-list. Perhaps we need an inter-committee working group to address this subject, which cuts across several subcommittees. Perhaps these waiting list issues should be focused on at the next meeting.

Solarz said that another problem is the communication link. We should work on our relationships with dialysis programs. Young agreed that we have done a good job on the transplant side, but nephrologists have not been educated about the issues with which we are dealing. There is an issue of access and an issue of wait-listing. Solarz suggested drafting a recommendation that focuses specifically on educating staff of dialysis centers and tying some portion of required continuing medical education credits to education about management of patients who are awaiting transplant.

Coolican made the point that this discussion is important also for patients and for those who donate. We must be able to ensure donors or their families that the best use is being made of the donated organ.

Harmon spoke about another consideration: why people turn down organs. Sometimes the person at the top will turn down organs when they become available until a better organ comes along. This is especially an issue with pediatric patients. Another issue he raised is the waitlist. The people who eventually get transplanted have been on the list longest. The longer they have been on the list, the poorer they do after transplant. We may be developing more unsuitable candidates because of allocating on the basis of time on the list.

Milford said that waitlist times vary widely from OPO to OPO. Every single patient on dialysis would do better with a transplant. Saving lives means transplantation. What should the criteria be for making decisions about the whole group on the waitlist?

Paige Cottingham-Streater articulated concern about the waitlist issue. She asked the committee to think about the family’s perspective and the notion of potential benefit. Do not overlook certain candidates because you are uncertain about the outcomes. Life and how we measure QOL depends on the individual recipient. Make sure as many people as possible have access to transplant. Do not limit people’s opportunities because of the fear of the unknown. Keep the process transparent. In each community these situations are handled differently. Apprise potential recipients about these potential differences.

Hunsicker said that one approach that has succeeded in some contexts is to work out the science without looking at ethics at all. For instance, we might be able to identify a group of people who receive no benefit from transplantation. It might be possible to do an extension of life study by underlying disease. These are scientific issues. Finding a scientific basis does not necessarily form the ethical basis. But, if we have the facts, we are in a better position to make a judgment.

Kahan said that a critical factor is cold ischemia time. It is not necessary to carry out a great deal of scientific study to look at the top people on your list and evaluate them as candidates. As waiting time gets more prominence on a nationwide level, some operational things need to be put in place at the OPO or regional level to improve the efficiency of the list.

Agrawal noted that the subcommittee had also discussed two other points but had not drafted recommendations:

• Does the black market for organs have an adverse effect on the U.S. transplant program? Patients go abroad and purchase an organ, which is transplanted outside the U.S. That patient is then cared for by a physician in the U.S. Anecdotal evidence suggests that this practice is something we need to look at because of the possible implications for our programs. We have no data to suggest whether this is a real problem and its extent, if it is. Would it be possible to gather data to find out how many people are doing this and a gauge of the burden on our health care system? It is a suggestion to HHS to gather such data and report to ACOT on the extent of this problem. If it is significant, ACOT could take it up.
• Should there be a reexamination of the valuable consideration prohibition in UAGA? Should we raise the issue of demonstration projects or something else?

Kahan said that ACOT’s been going around and around about valuable consideration since the Committee’s inception. We need to find a way to do a demonstration project. This is a valid question. Many people believe it will have an impact; others believe it will not. We need to do a demonstration project on a suitable scale so that it is not financially oppressive.

Hunsicker suggested that ACOT will not be able to reach a consensus on this topic. Although we do not have consensus, should ACOT say something about valuable consideration? Kress acknowledged that we have a wide diversity of viewpoints. There has been major debate on this topic. ACOT has assembled literature and invited presentations on this subject. This is not the time for a vote on this.

Kahan said that it is not up to ACOT to spell out the details of the valuable consideration. It is up to the contractor who proposes an idea to HHS. We just ask that the legislature move ahead so that such a demonstration could be undertaken.

Kress suggested that the group continue to work on this issue between now and the May 2004 meeting. He asked for a broad e-mail discussion of this topic. He asked whether this issue should be put to a vote at the May meeting. Kress asked Delmonico and others to help frame questions for further discussion. Ascher said that she hoped some of this work could be done before May. This will be a marching order for a subcommittee.

Report and Recommendations of Subcommittee C (Public Concerns)
Roger Evans, Ph.D.
Donor Education, Education, Recruitment, and Management

• Recommendation: The Division of Transplantation has funded numerous grants focusing on multicultural organ donation. The final reports for these grants should be reviewed in a timely manner and factors identified to distinguish successful from unsuccessful programs. The Division should report the results of this effort to ACOT and the procurement and transplant community.

There was some discussion about this recommendation. Hunsicker said that this really is a recommendation to ACOT itself, not to the Secretary. Evans agreed, but he noted that the recommendation calls for dissemination of the results to the “procurement and transplant community.” Seely also suggested that we would need to filter the results because a program that works in one place may not work in another.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: A consensus conference should be convened to identify and explore programs that are successful in enhancing minority donation. Programs in existence within the procurement community and those identified through the Division of Transplantation grant program should be highlighted.

Motion to adopt; seconded; passed by voice vote.

Access to Transplantation

• Recommendation: The Scientific Registry of Transplant Recipients (SRTR) (and any other relevant regulatory body with information regarding this issue, including CMS) should coordinate collection of data and develop an annual report that examines referrals for transplantation, transplant rates, waiting times, and outcome by race, ethnicity, sex, and region. The results should be reported to ACOT.

Hunsicker observed that some data are available at least in respect to kidneys, but we have not begun to look at the issues in regard to other organs. We need to begin to look at the rate at which people have end-stage organ disease, are getting transplanted, and so forth.

Kress asked if it is necessary to generate a separate report, or could it be part of a larger report by NIH or some other entity? Higgins said that the idea is that this reporting ought to be mandated or requested at ACOT’s or the Secretary’s level so that it can be monitored on a prospective or concurrent basis (not retrospective). We want to illuminate disparities.

Hunsicker brought up another aspect of this issue regarding extrarenal organs. We have a system in this country whereby anyone who needs a kidney can get one regardless of financial means. What fraction of the population lacks access to transplantation because of a lack of insurance?

• Recommendation: ACOT should request that OPTN and SRTR provide annual reports summarizing financial and insurance data on all patients listed and transplanted.

This reporting effort would be doable, according to Robert Wolfe of the SRTR. The SRTR presently identifies different sociodemographic groups. The SRTR has not undertaken financial analysis, but insurance data are available.

Kahan cautioned that this data collection effort would come close to the HIPAA borderline. As we get zip code and insurance data we are getting closer to the line. Kress said that we need to look at aggregate data. Milford opined that organ allocation may be exempt from HIPAA rules.

Insurance Coverage and Availability

• Recommendation: Based upon anecdotal information that living donors do experience difficulties pertaining to health insurance, a needs assessment should be undertaken to obtain a fuller understanding of the extent of the problem. The assessment should include questions about health, disability, and life insurance. A specific question should be asked about mental health coverage because a lack of parity remains a concern.

Solarz said that mental health parity is of national concern. There may be a cap on the number of mental health treatments, lifetime maximums, or coverage for only a limited percentage of mental health care costs. There should be parity with medical coverage.

Ascher stated that other safeguards (e.g., donor advocates, donor evaluation and work-up) would eliminate anyone whom we expect might experience a physical or mental health problem. Solarz cautioned that we cannot anticipate all problems. Insurance companies may be treating donation as a preexisting condition. There may be a need for emotional support, especially for family members because of emotional demands. Harmon agreed, saying that donation can have pro-found effects on the family. It is extremely important.

Public Perception, Including Distrust of the System

• Recommendation: The Department of Health and Human Services should encourage the American Academy of Neurology and other interested medical specialty organizations (e.g., American Academy of Pediatrics, Society for Critical Care Medicine, Child Neu-rology Society, American Association of Neurological Surgeons, Congress of Neurologi-cal Surgeons, American Neurological Association, and so forth) to update the practice guideline for brain death determination, and to work with hospitals, organ procurement organizations, the American Hospital Association, and other interested groups to develop tools for the documentation of brain death determination and for the promotion of consis-tent practices among hospitals.

Seely suggested that imminent death and clinical triggers should be included in discussion. Some physicians may be reluctant to adopt certain clinical triggers for declaration. Even a great policy for referral may not work if individuals are unwilling to change their practices. Sollinger asked if this topic could be addressed in a white paper. Kress said he will communicate these recommen-dations to Terri Tye.

Motion to adopt; seconded; passed by voice vote.

Patient Selection Criteria

• Recommendation: The Health Resources and Services Administration or another appropriate federal government agency should commission a study, which, in an unbiased manner, examines the legal, ethical, and medical bases (e.g., HIV/AIDS) for some clinical and all nonclinical transplant recipient selection criteria, as well as related issues.

Evans suggested undertaking a review of the literature and commenting on it. This effort should not be value-laden; it should be unbiased.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: To facilitate the aforementioned patient selection criteria examination process, it would be desirable if an appropriate Federal agency, or possibly a private organization or foundation, convenes a consensus development conference to initially explore and ultimately frame the underlying issues.

Kress suggested that it may be useful to combine these last two recommendations.

Motion to adopt; seconded; passed by voice vote.

Report and Recommendations of Subcommittee B (Recipient Concerns)
Kathy Turrisi, R.N., M.S.N.
What is preventing the use of DCD across the country? The reasons: (1) lack of clear definition about legal and ethical responsibilities since there is no clear definition of a procedure and no way to address reasonable questions; (2) lack of professional and public education and understanding; and (3) financial costs.

• Recommendation: That a consensus conference be held as a follow-up to the IOM report and recommendations. The purpose of this conference would be to develop a standard template for DCD and to generate a white paper regarding implementation and all the other factors that come into play.

There is no firm document to guide people through this process. Kress asked if there are particular groups that need to be included but which have not been in the past. Kahan said that the problem is a lack of specificity. Kress requested that anyone who has a protocol please submit it so we can use the protocols to build a template.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: A Uniform Declaration of Death Protocol should be established. Because there are limited studies on such a protocol, research initiatives should be funded.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: There should be a requirement that the OPO must be notified prior to life support being withdrawn on any patient.

The lack of a clear definition of imminent death creates a loophole for timeliness of referral. There should be clear parameters regarding imminent death. We are not capturing all referrals in a timely way because of the lack of a proper definition of imminent death. This step must occur.

Kress noted that UNOS has been developing protocols, although they have not been widely distributed. We can share materials with them and vice versa. Hunsicker said that the pathway must be clearly defined so that the OPO is involved at the appropriate time. Sollinger said that we must come up with a recommendation that these standards be enforced and designate an entity to do the enforcing.

Gunderson said that we need to maintain a sufficient window so that donation can occur. Turrisi suggested that the trigger could be the progression from aggressive care to palliative care. That’s why it is important to define imminent death. Kress said we need to figure out that exact point in the process for OPO notification so we can specify it. The same issue goes to the reimbursement issue.

Hunsicker said that the action part is the last sentence. Who is going to develop the clear parameters regarding imminent death? ACOT could do this or it could involve AOPO or hospital representatives. Perhaps it would be more effective to assemble a small ad hoc committee to work up specific test language. Then at the next meeting, we know we have a recommendation that will fly with AOPO.

Ascher noted that these recommendations all stem from the IOM report and could be dealt with in the context of a consensus conference. Hunsicker expressed concern that this seems to be a high-priority issue, which needs to be acted on quickly. All we need are the right words to frame the recommendations and this could be done using our usual wordsmithing and email modification process.

Kahan asked if we know how many DCDs and how many donations after brain death occur. It should be possible to go to the SRTR and find out which centers are doing the most DCD donors and get their protocols.

• Recommendation: ACOT endorses the HHS Breakthrough Collaborative’s efforts toward DCD identification and referral.

HRSA’s Virginia McBride came forward and discussed the HHS Breakthrough Collaborative, a concept based on the Model for Improvement for testing changes in a health care system. It is intended to increase organ donation. The collaborative itself is a series of events and organizations. They have an e-community for sharing information so that all teach and all learn. Site visits and interviews took place at six OPOs and 16 hospitals which demonstrated high conversion rates. The effort netted some best practices. Kress emphasized that it is an iterative and interactive process that generates feedback throughout.

Hunsicker said that it would probably not be useful to add to conditions of participation at this point, although that may be useful later on. How, then, do we move the community along this path? The collaborative and best practices seem to be the best way now.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: There should be coverage/reimbursement of any additional costs occasioned by DCD protocols. Presently, hospitals are not supposed to get reimbursed for costs prior to brain death. While we ask families to wait, we must ask families or their insurers to bear those costs.

A great deal of discussion occurred about another proposed recommendation: Diagnostic costs for donor evaluation even prior to the time of consent should be covered. Delmonico objected that evaluations done prior to consent constitute a battery. Nathan said that with DCD donors in particular, if the family decides to withdraw life support, we have to determine if the patient might be a suitable donor. These blood tests are often done before the family gives consent. That is common practice. Others disagreed. Nathan referred to the “Cost of Altruism” paper. There are costs involved related to donation that occur before the family gives consent for donation. Practices are changing because referrals are occurring earlier in the death process. We must make decisions about donor suitability before approaching the family. Marcos said that in his practice, they see this situation every day. Often they can get hold of laboratory data for tests done earlier. Kahan said that they get consent from the family for the tests. He objected to including language referring to any diagnostic tests being performed before consent is procured. Seely said that it comes down to relationship, communication, and process. What is important is that things have to be done to preserve a designated donor’s right to donate or the family’s right to consent to donation.

Delmonico made the point that if a detailed protocol were in place, we would have a better idea about where to apply these recommendations. We could better address trust issues. Turrisi suggested changing the wording of the recommendation where it refers to brain death. If we are going to include DCD donors, we need to change that.

Delmonico said that some of this discussion is premature to the template you want to bring forward. Kress said that the cost is being absorbed presently. As the number of DCD donors grows, the costs will have greater impact. We just want to address it early. He said that there will be behind-the-scenes work to recast this recommendation. If we can’t get agreement on it, so be it. Nathan said that this dilemma is arising because the practice of donation is changing. In the past the OPO did not get a call until both brain death exams were done; then the OPO would get a call after the first exam, then the OPO would get a call when it appeared that death was imminent. The OPO is called in to determine if the patient might be a donor. We are just providing an option for families. The patients are receiving optimal care.

Harmon suggested that we table this discussion for now. There is major distrust based on the discussions here. We need a better formulated recommendation. Email discussions will ensue.

• Recommendation: The current CMS reimbursement scheme for the transplant experience is a disincentive to use DCD organs and other lessoptimal organs. Although the long-term outcomes of using marginal organs appear good, the patients in whom these organs are placed experience more complications post-operatively; thus, they have a more expensive hospital course of treatment. Based on discussions with Marcia Newton of CMS, Turrisi recommended holding a meeting with the appropriate CMS personnel to discuss and to develop a plan of action related to the current DRG reimbursement structure, DCD and brain death acquisition costs, reimbursement of living donor travel and lodging expenses, and the Medicare Cost Report. We need an agenda and a plan.

Agrawal suggested refining the language for the recommendation along these lines: The role of ACOT is to advise the Secretary. We are not suggesting the Secretary meet with CMS. We ask that the Secretary acknowledge that the present reimbursement system was formulated at a time when the transplant community was doing something different from what it’s doing now. We ask that the Secretary examine the system in light of how the transplant system works today. The goal is to have the reimbursement system reflect current practice.

Kahan said we need specific data from centers about their costs, especially in regard to ECD donors. Turrisi agreed that we need cost data to bring to the meeting. In the past, transplant centers have not shared financial data. Sollinger said that it should be simple to get the figures, and he volunteered to demonstrate increases over baseline what the additional costs are. He already has some numbers in house.

Kress asked for more discussion of this recommendation via email. Marcos suggested possibly fragmenting this recommendation into three parts: marginal organs, DCD, and living donor expenses.

Delmonico said that the living donor expenses should be a stand-alone issue to bring to CMS and would likely receive the endorsement of the group.

Nathan noted that the Secretary can change policy for reimbursement. Regarding expanded criteria donors (ECD), the OPO gets “dinged” if two kidneys are transplanted into one patient. They have to pay back Medicare. They are being punished for aggressively pursuing transplantation of expanded criteria organs.

Higgins said that in terms of developing policy, this does not seem to be a mature recommendation. As a procedural point of order, this seems to merit discussion but is not yet ready as a specific recommendation.

Hunsicker said that if we accept this recommendation, the upshot is that we need to do a great deal of preparation for the meeting. How would such a group be constituted? Kress summarized by saying that he heard a number of relevant items for consideration by other groups, such as CMS and NIH, for their research agendas.

• Recommendation: There should be a research project or grant funded to review pre-transplant information packages provided to patients and evaluate the perception of recipients posttransplant regarding education efforts. Out of the information gleaned from this project or grant, a template or set of guidelines should be developed regarding patient information/education which should be incorporated into the informed consent process.

This subcommittee’s breakout discussions brought out the fact that some recipients and their families, before the patient undergoes a transplant, do not understand fully the likely postoperative course. For example, if the recipient has to go on life support posttransplant, sometimes the families want to withdraw care even if the organ is functioning. The result is a wasted organ. Turrisi agreed that the possibility of life-sustaining interventions should be discussed with the recipient and the family prior to transplant. Son-ja Robet Jones said that the patients should also be informed about the possibility of having to go back on dialysis for a time during the post-transplant course. Henry Krakauer suggested that educational materials should outline the experiences of patients who do well and patients who do disastrously. Milford agreed that patients have to know about the spectrum of possibilities that can occur posttransplant. Marcos recommended also covering neurological complications from immunosuppressive therapy, mood changes, and so forth in patient education materials. We have to make the information available at the patient’s level. Marcos said that another topic to address in the materials is pregnancy.

Son-ja Robet Jones said she learned more after her transplant than before. Beforehand, she did not even want to know all the possible complications. She mentioned a film she saw after her transplant that really showed the reality of immunosuppressive therapy. She also found it useful to talk to other patients to hear pros and cons. She would not have changed her mind about undergoing a transplant, but she wished she would have known. She said that videos would be a good educational medium.

We could do more education about the transplant experience while people are on dialysis awaiting transplant.

Son-ja Robet Jones said that it is important to educate patients so they can be their own advocates and empower them to be more involved in their own care.

Motion to adopt; seconded; passed by voice vote.

• Recommendation: Training on the organ donation process (including OPO reporting requirements) should be one of the yearly mandatory updates that hospital personnel are required to take. These updates should be tailored to meet the needs of the area where the employee works.

Turrisi said this is a compliance issue. The intensive care unit nurses have a module on organ donation and transplantation at Turrisi’s institution, for example. Members of the public ask hospital staff questions about organ donation. Hunsicker said that, frankly, more lives are saved by organ donation than by CPR, although CPR training is required of all hospital employees. Seely said that most OPOs disseminate education to relevant personnel in the hospital. Turrisi said the OPO should help develop these units, but the training should be a requirement at hospitals.

• Recommendation: Each transplant center should develop in conjunction with health care professionals a standardized case management model for caring for waitlisted patients. This model should include at least a periodic evaluation and interval updates. Long-term care plans and progress notes should reflect ongoing communication and updates.

The subcommittee’s discussions during the breakout session centered on the problem presented by patients who are sick or ineligible when they are called to the transplant center for a deceased donor transplant. Marcos said that at his center, they bring in patients three at a time to make sure they can transplant an organ when one becomes available. Turrisi said that it is not cost effective to call patients in for testing only to send them home.

The problem, according to Marcos, stems from the lack of communication between transplant doctors and dialysis doctors. This gap may cause complications and poor outcomes from transplant. Milford said that the dialysis doctor and those doing transplant evaluations are the ones responsible for patient care. The responsibility for determining and maintaining candidacy for transplant lies with the transplant center.

Marcos suggested that we need data to know how patients fare on the waiting list, especially drop outs and those who do not get to transplant because of changes in medical status. What are the most common reasons for turning down patients? Some of these data may be reflected in refusal codes. Bob Wolfe of the SRTR suggested that the subcommittee identify data elements that could be used to back such a measure. He said that the SRTR has all inpatient and outpatient records on Medicare patients. Younger patients usually have private insurance for the first couple of years, so there is a gap in Medicare records. Wolfe asked if it would be possible to capture most turndowns in a checklist of, say, six items.

Turrisi suggested that CMS may be the appropriate enforcer for such a measure. CMS, for example, makes sure that patients have care plans.

Milford said that in an HMO system, the HMO has all patient information longitudinally from all specialists in a single file. For private insurance patients, however, the records are scattered among different doctors, hospitals, dialysis centers, and specialists. He said that this lack of adequate documentation about patients’ health status on the waitlist results in them showing up for transplant but they cannot be transplanted.

Milford maintained that the focus must be on the transplant center. There must be a proactive mechanism in place at the transplant center to follow these patients. Turrisi said that many centers do not even do yearly evaluations. Sometimes coordinators can manage waitlist patients. Milford said that local nephrologists will not take responsibility for this step. The National Kidney Foundation exhorts patients to take a proactive approach to inform transplant centers of their health status (e.g., weight loss, amputation).

Marcos said we need a system—a case management model—to bring together the patient, the dialysis doctor (or other doctor outside of the transplant center), and the transplant team. Milford said that by maintaining patients on the waitlist who are not candidates for transplantation results in excess mortality, prolonged ischemia time, and wasted organs; therefore, we need a mechanism for proactive management of patients on the waitlist based on an agreed-upon set of criteria for managing those patients. The plan may be different for different centers; for example, it is likely that a center with a waitlist of 50 needs a different sort of system than a center with a wait-list of 500 would need.

The recommendation proffered by the subcommittee is a systematic way of standardizing how patients are monitored. Kress asked if there was general agreement on the evaluation component. Higgins cautioned that it sounds like ACOT is mandating medical practice—that action seems to be beyond the mandate of ACOT, but we can certainly promote these evaluations and updates.

• Recommendation: OPTN/UNOS should coordinate and direct transplant centers to review all current kidne wait-listed patients for appropriateness.

Solarz said that if patients were evaluated properly as per the previous recommendation, then the waitlist would be cleaned up as a matter of course. During the subcommittee’s breakout session, Wolfe said that waiting time is highly predictable in a given OPO; the waitlist could be checked 6 months prior to transplant. Some centers may be doing this already. This step would eliminate 3.5 years of monitoring that would not be cost effective. Turrisi suggested that UNOS should do a “clean sweep week” to remove ineligible patients from the waitlist. Wolfe said it would just be necessary to do it for the ones who are coming up.

Kress said that this topic will be addressed further at the May meeting. Seely said that this recommendation appears to be a huge, unfunded mandate. Hunsicker said that there are listing criteria in order to get credit for time. Many people have been left active so that they can accrue time. That’s about to change. We need an update from UNOS on what they are doing to address this.

Someone asked if we can get data from the SRTR about how many refusals occur because a patient is not ready at that time. The multiple turndown issue is being analyzed. There are data, but the analyses are not ready, according to Wolfe

• Recommendation: UNOS should develop new codes to capture information on patients who are called in for a transplant but are sent back home due to health reasons. Three issues exist: morbidity, mortality, and economics.

Another idea broached by Turrisi was to develop a tool or a refusal code to capture some of this information; saying a patient is “medically unsuitable” is not specific enough. The goal is to get better coding on the paper. The problems are the economics of patients going back and forth, cold ischemia time, and so forth. This topic was deferred until the next meeting.

• Recommendation: All transplant centers should develop, in conjunction with their state’s vocation rehabilitation department, a back-to-work program for recipients. The back-to-work referral should begin prior to transplantation.

Cottingham-Streater said that the Secretary may wish to endorse such programs on a national level. She suggested recasting the recommendation to say, “The Secretary may wish to endorse.…” Another participant suggested adding language to include living donors as well.

Hunsicker suggested consulting with UNOS/OPTN as to whether they want to include this measure in the criteria for transplant centers.

• Recommendation: OPTN should develop a national standardized transplant quality of life (QOL) assessment tool. The OPTN should then require all centers to distribute and collect the tool. The information collected should be used to help assess transplant endpoints other than mortality.

During the subcommittee’s breakout session, Milford said that measures of transplant outcomes are very limited presently: graft loss, patient survival, hospitalization. For real human beings, there are many stages in between. It behooves us to study what the appropriate tools would be to assess the economic and QOL status of patients posttransplant. It was proposed to fund a pilot study of a standardized QOL assessment tool on a subset of patients from different transplant centers. Turrisi said that we need to know—if only in terms of allocation—whether we are doing a service or disservice by transplanting some patients.

Milford suggested that we need to assess QOL at various time points before and after transplant.

Wolfe suggested assessing functional measures. He mentioned that on the dialysis side, the SF36 is a fairly standardized assessment form. Milford said that the current OPTN model for collecting data is from the centers, yet QOL must come from the patients. Wolfe asked if the intent behind this recommendation to balance the risks and benefits of transplant, or is it to identify patients who may do better with transplant?

Given the discussion we heard about the practice at Vanderbilt University, this recommendation aims to be supportive of what is already being done at some locations.

Hunsicker observed that this issue is being addressed by the Data Working Group, which has recommended to the SRTR and DoT that they use a validated survey instrument rather than develop a new instrument. This is already well in hand on strong scientific grounds. We probably don’t need a transplant-specific instrument.

Harmon observed that this recommendation seems to be a clinical practice guideline. We seem to be getting off the track of recommendations for the Secretary to endorse and implement. Turrisi said that we need information; this is a way to get that information and improve our practices.

Milford said that the recommendation comes on too strong. Recast the language to reflect that there is much we do not know. This information can be part of the informed consent process.

Kress suggested deferring this recommendation for further e-mail discussions and word crafting.

• Recommendation: This subcommittee requests that ACOT approve appointment of a rapid-action subcommittee (composed primarily of members of this subcommittee) to review the proposed CMS Regulation Concerning Transplant Centers and OPO Certification and Performance as soon as it is released, with recommendations to be forwarded to the entire ACOT for final action.

Kahan asked if it is the province of ACOT to do this, or is it up to individuals to act. Kress said that individuals usually act, but what was suggested here was that if people want to write Kress and be part of a rapid-action group that it would help to formulate a quick response during the 30- or 60-day comment period. Ascher said that based on the discussion here, it sounds like all of ACOT would like to be a part of the response. Kress agreed that, once the CMS regulation is made public, he would take it upon himself to so notify all ACOT members about the comment period.

Conclusion

Ascher briefly summarized the Committee’s accomplishments in terms of recommendations and future action items.