Hans Sollinger, Chair, ACOT
Dr. Sollinger called the meeting to order and introduced the new Executive Secretary, Remy Aronoff. The eight new ACOT members introduced themselves.
Laurence Chan, University of Colorado
Francis Delmonico, New England Organ Bank
Dr. Chan presented on the topic of public solicitation of living donors. He remarked that controversy is not new to organ transplantation, dating to the first successful transplant in 1954 of a kidney from one identical twin to another.
The evolving role of the living donor results from the improved outcomes among recipients, and increased demand, especially for kidneys. The number of living donor transplants has increased, particularly the number of those who are unrelated to the recipient. The growing transplant list is a major reason to support living donation.
Colorado experienced a case of a live organ donation that had been arranged through a commercial internet website. The surgical director did not realize this was the source of the donation and initially refused to perform the operation (the operation was eventually performed). On December 14, 2004, the University and its private, related hospitals issued a policy that, until professional organizations, such as UNOS and ACOT, issue a public statement on this issue, the hospital would not perform living donor donations arranged through commercial internet sites. There was a lot of controversy about this decision.
There are many questions and concerns in this area. The Matching Donors website contains statements which are not refined and need clarifications. Originally, both donors and recipients paid to be registered on the website — it costs $300/month. Commercial sites present the risk of leading to organ marketing. The National Organ Transplant Act does not permit "brokerage."
In March 2005, Dr. Sollinger visited Colorado to advise the hospital; this interaction was continued at a meeting held in Chicago in June 2005. There had been 13 patients transplanted in arrangements made by commercial sites as of November 1, 2005. There is variability in the statements of hospitals and other professional organizations; they usually state that the donor has to understand the risks and be prepared physically and psychologically to engage in donation. Many hospitals have changed their policies on this. There have been several publications in peer reviewed publications on the subject.
In November 2005, the University of Colorado Hospital and Transplant Team issued the following position statement on living donation.
In March 2006, Colorado held its Controversies in Transplantation Conference. Participants and topics included the founder of Matchingdonors.com ; and representatives from UNOS. Discussions covered organ trafficking, ethical issues (e.g., consent), and legal perspectives. The hope is that Matchingdonors.com will become a non-profit organization to mitigate the issue of financial gain. Dr. Chan noted that the field needs to care about the donors and to better understand their outcomes so that true informed consent can be provided.
Next, Dr. Delmonico gave his presentation on the same topic. He showed a slide of a flyer seeking a liver donation for a New England woman and a billboard seeking a liver donation for a young man in the Southwest. He stated that it is telling that people are so desperate they feel compelled to advertise in this way. The young woman survived and is doing well, but the young man died of metastatic disease. UNOS wishes to increase the number of transplants and decrease waste. Live donor donation is a new component for OPTN/UNOS, and live donation is very central to the activities. A strategic plan to increase donations is being implemented. Comments have been sought in the Federal Register on applying OPTN's regulations to live donations as well.
Dr. Delmonico and Walter Graham, Executive Director of the United Network for Organ Sharing (UNOS), published a paper with a plan on solicitation in the American Journal of Transplantation. The paper distinguishes between solicitations for live and deceased donations and proposes that public solicitation and directed donation for the latter would have a negative impact on the equitable allocation system. It is important to ensure that the most medically urgent person in the country gets the organ. He stressed that this needs to be addressed by the professional community. In terms of live donation, it's not possible to prohibit people from forming relationships and bonds over the internet, but there should be a very careful psychosocial assessment required of both donor and recipient.
UNOS is sponsoring a national conference in May to address the evaluation of the motivation of non-traditional types of kidney donors. Dr. Delmonico described the circumstances that would trigger identification of a high-risk, non-traditional donor. These include significant and on-going psychiatric issues; substance abuse or mental health issues; a desire for medical care; a relationship with the recipient; or other secondary gain. In the latter cases, more intense evaluation than ordinarily would be performed is needed.
JAMA has issued a consensus statement on live organ donors that has been included in CMS regulations for transplant centers. Dr. Delmonico asked ACOT to reflect upon the proposal to make a distinction between deceased and live donors. He noted that he doesn't think that it's possible to prohibit what happens when relationships develop over the internet, but it will be necessary to ensure that evaluation is conducted and principles are applied to the live donor.
Dr. Sollinger introduced the first discussion point: the distinction between deceased vs. live donor solicitation. It is inappropriate to pressure families who are in an emergency situation to donate organs; we need to be careful to avoid solicitation of deceased donor organs. Dr. Sollinger stated that the surgeon carries the burden of policing these matters. He questioned what an appropriate time-frame would be between someone seeing a public solicitation, and making a later donation to the person who advertised. Families should be encouraged to donate to the person who most needs the organs, over someone who has caught their eye in an advertisement. But, if a family declines to do this, what does the doctor do? This happened in New York last fall. Dr. Chan noted that there are no data on this. He has found, sometimes, when you ask a family to make an anonymous donation through the waiting list, they are resistant. People want to have a connection with the recipient. We need to compare the two groups of patients (directed vs. to the list) and assess differences between them.
Tommy Frieson asked about a case in which there's someone who needs an organ and they advertise. There's a potential donor who sees the ad and then an organ becomes available through death, and the family directs the donation to the advertiser. They weren't solicited, but they were directed in their decision-making. They were prompted about organ donation and decide to direct it to someone through the advertisement. Dr. Delmonico said that the doctor and the OPO have a responsibility to raise the issue of the people on the waiting list and their needs.
Anita Principe remarked that, in the New England case, the woman's press background enabled her to promote her cause effectively. When the UNOS system was explained to her, she got onto the waiting list and received an organ through the allocation system. It's all about explaining the system to families and their loved ones. Dr. Delmonico raised other examples of how far afield this can go: people following ambulances, approaching families in emergency wards, and soliciting directed donations. Kris Robinson asked if public billboards increase general donations once people understand that there are others who also need organs. Dr. Delmonico responded that we can't assess this, and we shouldn't endorse it.
Staff from the HHS Office of General Counsel noted that the current law allows a person to direct an organ where they wish — it's legal to direct to a solicited person rather than someone on the list. If there's already a relationship between two people, it's very clear that it's legal to direct a donation. The organ procurement organization (OPO) fulfills the request, and no one would object to a situation like this. Every State law provides that a person (or their authorizing agent) can make a directed donation, and this is Federal law. Under law, families are entitled to direct the donation where they will. The Secretary of the Department of Health and Human Services cannot change State law.
Nancy Bridges asked about the high-risk, solicited donor-people for whom individual characteristics may make the donation a problem and cause problems (e.g., motivation). All of the risks have analogies in other areas of medical practice; clinicians deal with these in other areas, but translating them into policy recommendations for the Secretary is difficult. Millie Solomon noted that there are analogies about giving informed consent; there are people who are in the gray zones (older children giving consent; those with fluctuating cognitive capacity). The capacity to make the decision is complicated with an unrelated, non-traditional, and live donor-the higher the risk, the higher the standard for decision-making needs to be.
Ms. Principe said that, when reviewing the donation process, one also has to think about the recipient and his/her family. Transplantation is a team approach that must involve social workers, psychiatrists, etc. You may never know for sure and the key thing is to engage in a multidisciplinary and team approach to the decision making process.
Richard Migliori expressed concerned about a two-class system based on the recipient's economics. We don't want profiteering, and we don't want money to play a role in who gets an organ. Doctors and OPOs are not the police to enforce the fact that no money has changed hands. There may be a need for a document attesting to the fact that there is no monetary gain. Transplant centers wonder about money being exchanged too; they may benefit from such an attestation.
Lewis Low noted that the definition of "public solicitation" is important. Where family members are willing to donate, it's a private solicitation; it can be extended to church members, etc., where there is a previous relationship. Solicitations may lead to relationships. Between these two, it's a gray area. Dr. Chan answered that you need to know how sustained and long-term the relationship. Colorado's legal department is developing guidelines on this, in terms of length of time, as there is no reference from professional organizations.
Jorge Reyes commented that this has happened locally for a long time, but the internet has exploded it and prompted successes that complicate the issue. ACOT needs to define risks and ensure that principles exist and are applied. Then the surgeon and the OPO have to make the final decisions.
Rhonda Boone asked if a transplant center is conducting solicitation by encouraging donations and how, if there is no long-term donor follow-up, can anyone give informed consent. Dr. Delmonico responded that we can't say "Uncle Sam wants your organ" and solicit, by public policy, organ donations. We make available information if people want it. In the medical community, when there's a family emergency, the question needs to be asked if there is a donor in the family — not to coerce someone into being a donor, but because it is a medical possibility. Dr. Chan said he is passionate about this — so many transplants occur, and there is no follow up; there is only one grant to track follow-up. How can we have a registry and not follow up on results?
The Organ Procurement and Transplantation Network/UNOS will soon have an adverse event recording process so that, if the donor dies or needs his/her own transplant, it will be mandatory to bring the fact to the Membership and Professional Standards Committee. ACOT must relay the message about the need for long-term follow up because one absolutely cannot get informed consent without information about long-term impact. Dr. Sollinger agreed that it was embarrassing that this doesn't exist. His center is trying to gather information on it.
Dr. Sollinger asked if ACOT members wanted to establish absolute guidelines or a framework on directed donations. Ms. Rosenzwieg suggested there could be categories of informed consent for different risk categories; making a psycho-social assessment is very complicated and it's unclear who makes that judgment. Dr. Delmonico said it doesn't need to be set in stone, but could be a recommendation that this happens. Dr. Solomon stressed that the transplant community could say we won't accept live donors for the highest risk transplant.
Dr. Bridges said it would be useful for doctors to have it worded in a way that it's an evolving area of practice and that the decision is likely to be a judgment of the transplant team; make the language supportive for the team. They are afraid of litigation and need to know what is right (e.g., not being discriminatory) as well as the fact that there's no way to make a final, concrete determination.
Dr. Reyes asked about the legal regulations for public solicitation. Could organizations like Matchingdonors.com be required to provide education when people register, directing them to UNOS? The site would probably say that there's no danger just from registering some one. The transplant centers can't have all of the responsibility. UNOS could have its own registry and undercut the other sites. Advertising on the part of transplant centers has been a concern and should be addressed in any recommendation(s) on solicitation.
Dr. Sollinger will ask individuals to draft recommendations and bring them back to the group on Friday. There seems to be agreement about a crucial distinction between public solicitations of live versus deceased donors. Public solicitation of deceased donations needs to be assessed by the OPO on the scene; people should not circumvent the donor list by replying to billboards and other solicitations; and no money should be exchanged.
Mark Stegall, Mayo Clinic
Dr. Stegall presented a new model for allocating kidneys. In March 2006, there were 65,338 people on the UNOS deceased donor kidney waiting list. In 2005, 15,209 kidneys were transplanted, 9,188 of which came from deceased donors. The demand is growing faster than supply. The median number of days in which 50 percent of the candidates have been transplanted varies by blood type—people with AB (the easiest to transplant) now wait up to two years; half of the Bs are still waiting.
The UNOS Board charged the Kidney Allocation Review Subcommittee (KARS) with reviewing kidney allocation and to impact mortality and morbidity on the waiting list and increase the benefits from kidney transplantation. Dr. Stegall described the outreach process used to collect information and hold public hearings on the subject. KARS was eventually combined with regional representatives and the Kidney Transplantation Committee.
The current system has limitations and inefficiencies; it is not being optimized. Problems include the fact that kidneys with long expectancies are going to recipients with short life expectancy; the system is unpredictable about how long people wait; and there is variability in terms of access to kidney transplantation.
The proposed revised system would:
The new proposed SCD allocation has a goal of maximizing total number of life years gained by candidates on the waiting list for a deceased donor kidney. The Net Lifetime Survival Benefit (NLSB) is calculated from estimated candidate survival time with an SCD transplant, minus the estimated survival time while staying on the waiting list without a transplant.
Survival with end stage renal disease (ESRD) varies with age. For 50-60 year olds, patients do better with a transplant. The chart indicates that 20-30 year olds do well on the waiting list, and do better after a transplant. Over 30 years, the net life saving benefit (NLSB) is greater for 20-year-olds than for 30-year-olds, and increases over length of time. Factors that affect the NLSB include age, diabetes, ESRD, body mass index (BMI), angina, gender, etc. The committee is assessing what factors should be included; factors that are both important and can be objectively measured will be included. The committee excluded those that are unimportant or can't be measured such as ethnicity, gender, calendar year of listing, insurance status, angina, etc. The committee members are working on definitions (e.g., diabetes) and exploring whether the factors differ for diabetics, for kidney vs. kidney-pancreas patients, etc. Unintended consequences were also considered and the committee is currently addressing them.
Dr. Stegall addressed the benefits for different populations of the new system. Kidney-pancreas patients, which make up a small percentage of the list, have really great outcomes; older diabetics and non-diabetics have worst outcomes, as they have a high waitlist mortality and low post-transplant life expectancy. The model also gives more weight to a year of life post-transplant versus a year on dialysis. In the new sensitized patients' model, all patients will be screened for human leukocyte antigen (HLA); identify specificities and list unacceptable antigens for all patients. Another issue is that the A2 to B system has been shown to be successful in several places.
This will be a national protocol and the goal is to present the final proposal to the OPTN Board in December 2006.
Dr. Sollinger thanked Dr. Stegall for his work on this effort, and commented that the model presents a statistical framework for what a surgeon knows from experience. This is helpful from a conceptual standpoint. The unintended consequences are real, but can be addressed. There is a concern that the system might discriminate, e.g., against obese people with a higher BMI or against older people. Dr. Stegall responded that everyone is waiting longer and there are too many recipients for the number of available kidneys. The ECD kidney is a way to transplant people who have been waiting for a long time, and some work well. Patients who should be on an ECD list have not been identified.
Dr. Reyes asked about using NLSB to create model end-stage liver disease (MELD) scores for kidney candidates. Dr. Stegall responded that almost every candidate benefits from kidney transplants. Donor characteristics are put into the model, and benefits specific to the donor are calculated. It's important to inform the physician about life outcome from accepting a particular organ or not. It will help in deciding about organs in particular situations.
Ms. Principe said that New York has many ECDs and asked if the definition of the ECD donor will remain the same. Dr. Stegall said about 20 percent of kidneys are ECDs and the pool is expanding. The criteria need to be revisited, but this should happen later. ECD was created to increase acceptance of these kidneys, which have a high discard rate because it takes a long time to find a match. If the OPOs could find someone who wants the kidney they could use it. ECD will be revisited later and efficiency and benefits will be assessed.
Dr. Solomon said that she is concerned that a model based on efficiency and survival risks further disadvantaging already-disadvantaged groups. It's utilitarian, which collides with equity. BMI, for example, is connected with ethnicity and class. Not tracking people by ethnicity complicates this. You have to be able to track survival and outcomes by ethnicity and socio-economic status (or by an socio-economic status proxy such as zip code). Dr. Stegall responded that patients will be able to be tracked by ethnicity using UNOS data, but this will not be a factor in the model for selecting patients. Equity issues are being examined. There are other surrogates that are being considered. Of people on the list who are under age 40, 42 percent are African American; under the new model, these patients would have better outcomes than they do now, which is not discriminatory. The simulations will tell us more and we'll report back.
Howard Nathan, Gift of Life Donor Program
Hans Sollinger, University of Wisconsin
Dr. Sollinger began by noting that he fears that, if costs continue to rise, hospitals will decline organs and limit the number of transplants they perform. There are no data on the hospital (e.g., non-OPO) side; it is almost impossible to get costs. At his facility, the length of stay for a donation after cardiac death (DCD) donor is about five days longer than with a traditional deceased donation. He has talked with Bob Wolfe, Deputy Director, Scientific Registry for Transplant Recipients, about collecting a sample of approximately 200 DCD donors and asking UHS to compare costs with an age-matched group. The committee members discussed the possibility and agreed that this is worth pursuing.
Mr. Nathan presented on the costs associated with organ acquisition. He began by describing the Organ Donation Breakthrough Collaborative, noting that there are 58 OPO service areas nationally, 52 of which are independent and have their own provider number for Centers for Medicare and Medicaid Services (CMS) reimbursement. (CMS reimburses for kidney organ procurement.) He defined DCD and noted that both DCD and brain dead donations have grown since the 1990s.
Mr. Nathan described the difference between the processes and timing for a potential brain dead versus DCD organ donor. Routine care for brain dead patient before death goes on the patient's bill. With a DCD, the family decides to withdraw care and their costs essentially end at that point. The need to maintain the patient for some time afterwards engenders costs. Realistically, the OPOs should pay the costs for a DCD after the family decides to withdraw care. Insurance companies are dependent on the hospital billing department to send it over to the OPO, but the system isn't perfect. Most OPOs do not have contracts with hospitals and, therefore, have to negotiate bills. Hospitals probably get higher reimbursement from OPOs than from insurance companies. Some OPOs ask for the patient's and the donor's bills and examine them both.
CMS is primarily interested in renal costs; it controls and audits each OPO annually. Direct acquisition costs are covered, as well as other costs like G&A and education. About 40 percent of the costs are indirect; about 21 percent are donor hospital costs. CMS estimates a Standard Acquisition Charge (SAC) based on all of these factors and promotes rules about what is reimbursable. Fees vary across the country for kidney — from $16,000 to $32,000. Based on the current CMS standards, the line for accruing costs stems from declaration of brain death and is different for DCDs. The hope would be that no costs should be sent to the family and that CMS reimburses OPOs for those costs.
The group discussed various costs of organ retrieval, and the difficulties in billing. The group discussed why hospitals are at liberty to decide not to perform DCD, and the necessary process to get DCD through CMS as a national policy. The Association of Organ Procurement Organizations board of directors recently passed a policy position on DCD.
Dr. Bridges asked the group to consider public sentiment and understanding about DCD. To push such a recommendation before the public is ready could be very harmful for promoting organ donation. Dr. Sollinger countered by noting he hasn't had a single complaint about this from families. Dr. Scantlebury described resistance from faculty administration and ethics committees, and expressed her opinion that a lot of education is needed. Some felt that ACOT should recommend that, if a hospital is a donor hospital, it should also perform DCDs. Mr. Frieson said that getting an attending physician to pronounce cardiac death is extremely hard; if they don't die within 90 minutes, you have to bring them back into the ICU. Dr. Low concurred that the comfort level of nurses and doctors in the ICU is critical.
Dr. Solomon reported that she hears that hospitals view this as a recommendation from IOM, not a requirement. People fear that the process of early evaluation and referral to an OPO may influence the decision to withdraw treatment. Mr. Nathan noted that DCD only occurs after the family decides to withdraw care and there are standards of care around how this happens. Hospitals already comfort families and help them decide. With DCD, donation is only discussed after this happens; it's just one additional thing to tell the family afterthey have made a decision.
Ms. Principe noted that DCDs used to be performed before there was comfort level around brain death. There has to be a mechanism to educate the public about cardiac death. This option is a part of the extension of end-of-life care and giving families an opportunity to grieve and recover. Dr. Solomon said that all of these worries are speculation and that ACOT could recommend an empirical study that looks at the facts and helps shape our discussion. Dr. Jim Burdick also suggested that the Breakthrough Collaborative might help push this topic.
Ms. Conrad suggested an ACOT recommendation that the OPO should be responsible for the donor bill from the time of consent. Dr. Sollinger said that this would be a point to be discussed in greater detail at the next meeting.
Kris Robinson, American Association of Kidney Patients
Ms. Robinson described current CMS coverage for kidney transplants—most patients receive Part B reimbursement. Key issues that complicate the situation include the time-consuming process of confirming Part D enrollment, confusion on the part of pharmacies about billing, issues stemming from dual eligibility for Medicare and Medicaid, lack of access to State assistance programs, and issues surrounding share-of-costs and spend-down in select States. These problems hamper patients from getting drugs and may result in their losing their organs or not getting a needed transplant. Ms. Robinson described what can be done to assist patients and to educate pharmacists—solutions include CMS implementing a Part D hotline to get help to patients faster.
Dr. Rosenzweig asked about the need for patients and advocates to work with CMS and to fix the drug plan, rather than focusing on the State levels. Dr. Migliori thanked Ms. Robinson for her clear explanation of the problems with the programs; the threats to patients are very extreme when drugs are not available. He also noted that immunosuppressant regimens are very specific and it's troubling that patients appear to be expected to shift between varying regimens because of pharmaceutical coverage. Dr. Scantlebury agreed that it is an all-consuming process to get drugs for her patients, most of whom are dual eligibles. Ms. Robinson reported that every transplant surgeon with whom she spoke had at least one patient who had lost their transplant because they could not get access to immunosuppressant drugs and medications.
Dr. Sollinger asked what the committee can do about this. Ms. Robinson said that a hotline specifically for transplants would be very helpful — for patients, as well as pharmacists. The Medicare number is often busy and staff who answer often lack expertise in this area.
Dennis Wagner, Division of Transplantation
Mr. Wagner updated the group on the Breakthrough Collaboratives. There is a much more robust community of practice today in the U.S. working together in a more cohesive and transparent manner. New practices are quickly identified and shared. In the old system (before 2003), there were an average of 508 donors per month; now the average is 614 per month. The new goal is to achieve a mean of 750 donors per month.
It is clear how to achieve and sustain 75 percent donation rates — Iowa and Wisconsin have achieved this in their entire donation area. Changes that make a difference include: advocate organ donation as a mission; involve senior leadership to get results; deploy a self-organizing OPO/hospital team; practice early referral and rapid response; master effective requesting; and implement donation after cardiac death.
The Organ Transplantation Breakthrough Collaborative change practice identified what occurred in the highest performing donation service areas and found that (1) there is a culture of intent to transplant as many organs per donor as possible; (2) relationships are in place; (3) advanced practice in clinical management rests with the hospital or the OPO; (4) the OPO pushes to place organs; and (5) the transplant facilities pull in many organs and use as many as possible. Each of these practices can be facilitated by specific actions. Duke, for example, sends a team to look at organs they might not otherwise use, and ends up taking more of the organs as a result. It's more costly, but it's worth it. Investment in resources yields payoff. The results of the Action One period show that some teams exceeded the goal. The successes resulted from taking the appropriate time to optimize organ function and place organs. These teams also involve critical care specialists in donor management, and they have mutual accountability between the OPO and facility to optimize organ use.
Mr. Wagner described the Collaborative's future goals, which include to:
Mr. Wagner stated that between 2003–2005, the Washington Regional Transplant Consortium almost tripled the number of kidneys transplanted at the Washington Hospital Center — from 24 to 78 kidneys.
Howard Nathan, Gift of Life Donor Program
Mr. Nathan discussed the fact that the education and training opportunities for professionals are limited, once these professionals return home. The Gift of Life Institute provides practical, day-to-day learning. It started with an empty warehouse and now is a building housing a call center, recovery suites, operating rooms, training institute with practicum facilities, and more. The call center handles 52,000 calls a year. The recovery suite is an idea that came from St. Louis: a place to conduct retrieval of organs from brain dead donors in the facility. Many training and education activities occur on issues that include gaining consent, ensuring best practices, clinical practicum, DCD, etc. Funding was obtained by a $1.5 million municipal bond.
Francis Wright, Texas Transplant Institute
Dr. Wright presented on financial considerations with respect to transplantation of sensitized renal patients. Sensitization is the presence of HLA antibodies that causes incompatibilities with potential donors; it traditionally has been measured by elevated panel reactive antibodies (PRAs). Sensitization can result in patients waiting longer or dying on the list.
On the UNOS kidney waiting list, almost one-third of patients have some level of sensitization. The ability to identify sensitization has improved greatly over the last several years.
Two solutions have been promoted: the "West Coast" solution is to explore immunoglobulin to interfere with antibody production. Dr. Wright described the second, "East Coast", approach; this which removes circulating antibodies through plasmapheresis. Dr. Wright described the benefits and problems associated with plasmapheresis as well as the protocols for pre-transplantation, admission, and post-transplantation. The costs for histocompatability testing do not greatly differ from tests conducted for sensitized patients on the waiting list. The plasmapheresis portion of the treatment is dependent on IVIG preparation, however; and there is a shortage of IVIG right now, which affects costs. A typical case costs about $18-20,000 in total. Dr. Wright discussed post-transplantation rejection rates and ways to improve both costs and outcomes.
Several funding sources exist including the Kidney Acquisition Cost Center and use of the Ambulatory Patient Codes. There could also be an adjustment in DRG rates/codes for desensitization cases. Dr. Wright has been fairly successful in obtaining coverage from private insurance for his patients. Dr. Wright described future potential outcomes that will include increasing living donor transplants and decreasing patients going on the waiting list. He also suggested recommendations for moving forward.
Ms. Conrad asked about the process for a deceased donor population. Dr. Migliori asked about complication rates between the two protocols (East vs. West Coast) and the long-term results for these patients. Dr. Reyes asked about reimbursement and was told that, at the present time, it is negotiated on an individual basis. Dr. Bridges asked if data have been presented to the FDA and CMS with a goal of getting a payment plan. Dr. Wright does not know if the pharmaceutical industry has approached the agencies yet. He noted that removal of language prohibiting Medicare reimbursement for plasmapheresis has been helpful, but that payment is now up to the individual payers. Mrs. Boone asked if the process poses any additional risk to the donors. Dr. Wright noted that the recipient is at higher risk and he or she may have higher rate of rejection; but there are no additional risks for the donor.
Miles Kaye (Rockville, MD) — Mr. Kaye identified that his wife is a liver transplant recipient.
Note: The "U. Cal Irvine situation" refers to serious deficiencies in patient care involving onsite medical/surgical coverage at UCI's liver transplant program; UCI's waitlist, graft and patient survival for its liver transplant program; and UCI's submission of documentation that contained potentially false representations about the onsite coverage of certain key personnel.
Mr. Aronoff presented a certificate and letter of appreciation from HHS Secretary Michael Leavitt to Dr. Sollinger, who is concluding his final meeting as ACOT member and chair.
Richard Migliori, United Resources Network
Dr. Migliori stressed that this presentation highlights his personal interpretation of materials collected by him; it is not scientifically valid, and only represents his views. He presented on issues of insurability for donors. It is widely believed that donor needs are covered and insurance documentation clearly indicates this should be the case.
The clinical capability of the U.S. medical industry is unmatched in the world, which is expensive. Health insurance costs are rising. Health care expenditures represent 17 cents out of every dollar spent in the U.S., and costs are growing about 10 percent a year. Increasingly, employers are not providing health insurance to their employees. In terms of donor insurability, there is a lot of confusion about insurance responsibility for donor costs at transplant and afterwards. Donor insurability concerns breed apprehension about donation; this confusion leads to less optimal care and other problems for donors.
The North American Transplant Coordinators Organization (NATCO) surveyed liver and kidney centers in 2006 and found several interesting things. For example:
Dr. Migliori examined insurance policies and found that coverage for donor services are the responsibility of the recipient's policy; this is spelled out in the policies very carefully. Group insurance policies (which are normally employer-based) treat a post-donation issue as a complication from a prior condition, and pay it. Donors tend to be very healthy and the insurers would rather get their premium than spend the time trying to reject them. He noted that individual insurance coverage is a little more restrictive. Typically, however, policies accept donors as long as they have recovered with no other significant medical conditions. Donors may buy an impairment rider if they have had problems. The latter are those who are likely to be at risk, although they can go back to recipient insurance for coverage. If either the donor or recipient is confused about insurance coverage, there can be delays or care can be affected. This is a big concern.
Dr. Migliori noted that donors are concerned about their insurability and health care, exceeding their lifetime maximum limits on care, and whether seeking care for complications will affect their insurability. Donors also are worried about portability, fearing that a new employee's plan won't cover effects of the donation. They should not be burdened by this. In addition, these issues crimp the availability of organs.
Dr. Migliori presented a set of principles for discussion which include:
Dr. Migliori also presented solutions that would advance these principles, including:
Mrs. Boone thanked Dr. Migliori for his work on this subject and noted that his ideas address many of the concerns she has experienced and heard from other donor families. In turn, he thanked her for advocating on behalf of donors, which directly led to his presentation.
Dr. Rosenzweig commented that she is skeptical of some of the solutions. If we were going to change Federal law to prevent use of preexisting conditions or denial of portability, how would it be enforced, particularly after some time has passed. Dr. Migliori responded that he is not advocating that, but rather is suggesting that, in these rare cases, there needs to be protection through the public arena. The bottom line is that people should not be discriminated against because they have been an organ donor. It is not at all clear that this ever happens, but it's a fear that people have. Kidney recipients are or will become Medicare recipients with ESRD; therefore, covering donors more fully actually offsets funds that would be spent on the recipient if they don't get a new kidney.
Dr. Solomon asked about creating a change in practice; how to get a response rate greater than 16 percent from centers so that standards can be created and published. She has heard stories where the transplant team itself didn't know about coverage for donors and the consequences were bad. Dr. Migliori responded that the low response rate has already identified a major problem that needs to be addressed. Even if the problem among all centers is actually less than indicated by the survey, it's still an enormous issue that must be addressed. The solution is in providing information to the donor at the same time as the informed consent for the donation occurs.
Dr. Wright commented from the floor that there is an insurance package for kidney donors offering good coverage. It is underwritten by American International Group, Inc., (AIG) and modeled after the bone marrow field. It is administered through the American Foundation for Donation and Transplantation, which collects follow-up information on kidney donors. Two claims have been paid to date. It can be purchased by individuals or by the centers.
Ms. Principe expressed concerns about mandating the center not to seek information from the donor's policy. This should be directed at the insurance companies, because they dictate the practices and often won't proceed with payment until they get a letter from the donor's company. Centers shouldn't even know the policy from the donor, particularly given issues of confidentiality. Dr. Migliori agreed wholeheartedly and noted that the insurers' practice of billing the donor's policy and seeing what happens is really problematic. Mrs. Boone described her situation and said she doesn't know how the hospital acquired their insurance coverage information, unless it was from the off-site blood test procedure.
Dr. Migliori suggested that ACOT consider the solutions he presented. Dr. Scantlebury agreed that these are real issues ACOT needs to consider.
James Burdick, Division of Transplantation
Dr. Burdick talked about other Federal efforts connected with donors. The OPTN process for the registry and rules have been in place for less than 20 years. There is a role for the Federal Government to protect the living donor. Several activities are on-going that will be helpful:
There has been a Federal Register notice on OPTN's policies that living donations have the same standards and enforceability as deceased donations. He noted that there is a desire to provide grants to cover expenses for low income donors; this was unsuccessful last year but efforts to create it will be on-going.
Ms. Conrad said that she was surprised that, when she donated her kidney, travel and lodging were not covered by insurance and the donor had to pay out-of-pocket. She noted that the Medicare system is benefiting because the recipient did not have to go on dialysis which saved a lot of money. Dr. Conti suggested pursuing Medicare eligibility for all live donors.
Dr. Sollinger noted that we have been waiting for these changes for a long time, but he expressed pleasure that the transplantation field is paving the way for donors. Mrs. Boone responded that this makes her feel a lot better, that things can change, even though it takes a while. She wondered why there has been a delay in doing long-term follow up. Dr. Burdick responded that the delay results from funding issues: he noted that it is hard for federal programs to be inventive and do new things when funds are being cut. The federal government is engaged in a very constructive process, begun by the community, to reduce the amount of information that transplant programs have to send to OPTN. So, it would be necessary to justify the collection of more information from centers, and to clarify exactly what is to be collected. The NIH effort will help define the best information to collect, which will help in advocating for funding on this.
James Childress, University of Virginia
Dr. Childress served as chair of IOM's Committee on Increasing Rates of Organ Donation. He presented on the findings of the IOM study —Organ Donation: Opportunities for Action — to be released this week. He discussed the IOM's task and the guiding perspectives and principles used by the IOM group. He stressed that fairness is important in both benefits and burdens. IOM also looked at the effects on disadvantaged groups. Recommendations to support organ donation include:
There are about 12,000 potential donors in the U.S. each year, of which about half are actual donors. Circulatory determination of death (including DCD) presents a larger pool of 22,000 potential donors, of which only 270 were donors in 2003. Dr. Childress discussed the difference between controlled and uncontrolled death and how this affects the donor pools. IOM is very interested in increasing donation after circulatory determination of death (DCDD) by funding demonstration projects, increasing other initiatives to encourage the practice, maintaining opportunities for organ donations, and increasing research on organ quality and enhanced organ viability.
IOM also looked at ways to increase the public understanding and appreciation of organ donation, and presented the committee's findings on issues of presumed consent. Evidence suggests that the U.S. public is not yet informed enough about donation to implement the practice of presumed consent; and it might, therefore, harm overall donation efforts. IOM suggests, instead, that public support be built to create a society where it's presumed that one will be a donor.
IOM considered financial and non-financial incentives to donation. IOM suggests that the U.S. should not adopt financial incentives (which raise issues of commodification) at this time nor should the U.S. institute preferential access to future services for donors and/or their families. While IOM was not asked to look at living donors, the committee did consider the impact of living donation on the field.
Mr. Frieson asked about DCDD and issues of family consent and legal/ethical issues. Dr. Childress described past and successful pilots, notably at the Washington Hospital Center in the 1990s. The DC City Council passed regulations to promote this practice, in fact, and Virginia and Florida also have such supporting laws. It will be important to have demonstration projects to assess the success of the idea. Mr. Frieson noted that, given Thursday's conversation about DCDD and the profession's lack of comfort with this practice, it seems like DCDD would face the same issues. Dr. Childress reported that the public is pretty comfortable with DCDD, since it is how most people are declared dead. The public is less comfortable with neurologic death, while hospitals are more comfortable with neurologic death.
Ms. Robinson reported that pilot studies indicate that financial incentives — like travel expenses and funeral expenses — are popular. Dr. Childress noted the distinction between the removal of financial barriers, which is for living donors and is fair, compared to deceased donors, for which it is unnecessary and probably unneeded.
Dr. Reyes asked about requiring hospitals to have DCDD policies at this time. Dr. Solomon reported that several IOM reports have suggested this. The question discussed yesterday was whether this should be a CMS requirement, but Dr. Childress stated that this question had not been discussed by the IOM committee. Dr. David Vega said that hospitals are overwhelmed by their trauma patients and do not have the capacity to perform the activities required to keep organs viable. Dr. Childress said this is exactly why a demonstration project is necessary—to test it before we move ahead.
Arthur Matas, University of Minnesota
Dr. Matas reminded the group of the growth in the waiting list for organs, which results in increased median waiting time for kidney donations and deaths among those on the waiting list. Overall, the percent that die on the waiting list has increased from 6 to 8 percent. These deaths are not, as one might think, among the most elderly people on the list. The mean age is 54, and most of them are unsensitized. The argument for sales of living donor organs stems from the 5-10 year wait for organs, the increased number of deaths among those on the list, and the fact that the projected supply cannot meet the demand. It is agreed by everyone that there should not be financial disincentives for donation.
In order to debate sales, we must all debate the same sales systems. What has been happening is that supporters and detractors describe different systems. Dr. Matas proposes a specific, regulated system of payment that provides a fixed price (that has no tax implications) to the donor with allocation based on a fixed algorithm.
In terms of a regulated system, payment to donors does not need to be monetary. It can be composed of access to health insurance, a tax benefit, life insurance, etc. Many organizations have supported sales, including the International Forum for Transplant Ethics. Prohibition of sales of one's own body interferes with an individual's autonomy and conflicts with our social standards of individual liberty. It is legal to donate other parts of the body, such as sperm or eggs, and monetary self-interest alone is neither illegal nor uncommon. Sales currently occur in an unregulated factor, and legalization can minimize this. Organ sales are economically feasible for the health care system. Over 20 years, the expected savings to the health system of getting a kidney vs. staying on dialysis are about $95,000. It is, therefore, cost neutral to pay the vendor up to this amount (minus costs for administrating the system).
An argument against sales has to make the distinction between sales and donation. Dr. Matas presented current arguments against sales and his response to these objections. Dr. Matas described other regulated sales systems which occur today and touched on the issue of commodification. He noted that experiences in sperm and egg donation have indicated that commodification isn't actually an issue for these donors and that people understand that their humanity is not the same as their body part ("I am not my kidney"). A sales system allows the individual to decide for him or herself what to do with his or her own body through a system that provides screening and regulation. Those who have issues with their body integrity do not, in the end, need to become donors.
Another common argument against sales is that it will hurt the poor, that financial considerations will override their judgment. Yet, selling on the part of the poor is not exploitive if everyone benefits and the vendor is making an autonomous decision that can improve his/her own quality of life. The system can be regulated to ensure that informed consent is intensive and the donation is voluntary. There is a difference between choices that are hard and choices that are voluntary. To deny low income people this option implies that they are incapable of making decisions. If we consider financial pressure on a donor, then we have to consider also that there is emotional pressure that exists for donors, too. Prohibiting low income people from selling their organs doesn't really help them, and leaves them poor. Finally, we allow low income people do lots of things and engage in activities rich people won't do (like join the military or work in mines) that have greater risks than organ donation.
Some suggest that the health care relationship will be harmed by organ sales but there is no evidence to support this. In other instances with sales, people (surrogate mothers) get great care, for example. Some think that religious organizations might object, but separation of church and state necessitates that churches and other religious organizations not dictate public policy. Additionally, it is thought that donation must be altruistic, but it's not clear why this should be so. Finally, people fear that the system could be abused if donors lie about health, but screening will prevent this. Doctors and donors can game the system now, anyway, and the possibility of abuse is not a reason not to do something.
Public surveys have indicated that the public supports organ sales, while doctors and nurses are more likely to oppose it. There are, of course, practical considerations to such a system which include: setting a minimum age for donors; establishing a geographic area for vendors; providing long-term care; providing long-term follow up; providing payment; verifying donor's status; handling logistics; designating a price; and drawing the line at kidneys (because we know the most about these donors). The practical concerns do not mean it's not worth pursuing. Dr. Matas presented his principles for ethical sales.
Dr. Solomon asked that we have an ethical analysis on the other position to balance the debate and Dr. Sollinger agreed to do this. The ACOT members unanimously agreed to continue this discussion.
Dr. Solomon remarked that the proposed sales system does not address the IOM concerns about fairness. The proposal makes a libertarian argument about autonomy, but there is precedence where society trumps autonomy, as with physician-assisted suicide. This has been rejected by the community despite a social commitment to individual rights. Dr. Matas agreed that the debate should be aired and on the table. He noted that bioethical and practical issues are more critical than rights issues. He asked if there are issues that trump the fact that people are dying on the list.
Ms. Robinson noted that patient organizations are interested in exploring this issue. Patients who need organs do not want to stay on the list and do not want to die. She stressed that wealthy people are able to do lots of things that poor people can't do — like get fertility treatments — and that consent of the vendor is what's most important.
Dr. Scantelbury stated that she connects a regulated sales system with the web-based connections. If we can regulate such a system, and compensate people in ways that may not be cash, we can help with the problems raised yesterday. Access to other routes is fairer than having only those who can pay $300 to be registered in a commercial registry.
Dr. Leffell asked if payment would result in increases in the number of living donors. Dr. Matas responded that the previous presentation on coverage stressed potential donors' concerns about their insurability — such a plan could help overcome those fears and ensure good, long-term care. Further, any system would evaluate people just like we do now, so only the appropriate donors would be accepted. It might be necessary to evaluate a possible donor twice over a period of time to overcome the fear of people misrepresenting themselves.
Dr. Bridges reminded the committee that we don't really know the long-term outcomes for donors and we do provide health care or protections to today's altruistic donors. She suggested that, if the system served these donors better with support services, health care and information, it would encourage more people to participate as voluntary donors. Dr. Bridges said that it's not clear that vendors can be evaluated as stringently as well as someone who comes forward because of families or other connections. Dr. Matas disagreed, stating that finding a donor through a church flyer or message at an office does not differ from someone who comes in because of a billboard. Data do not indicate that there is any difference between these types of donors, although further study would be helpful here.
Dr. Conti noted that he is uncomfortable because everyone benefits from the system currently, e.g., surgeon, the facility, everyone except the donors.
Mike Seely, Pacific Northwest Transplant Bank
Mr. Seely presented on the committee's recommendations on the framework for tissue regulation and oversight. He described the committee's past discussion and process to create the recommendations. The focus is on potential Federal oversight, although there is currently the potential for State oversight. The committee looked at regulation of solid organs, tissue, and whole body donations and examined the goals of preserving the public trust, meeting transplant needs, assuring public safety, and advancing science. Risk-benefits vary among these tissues.
Solid organ oversight
In Mr. Seely's community, unregulated companies are providing free cremation for those who donate their bodies. It is not clear what the bodies are being used for (e.g., the Army has used bodies to test land mines). There should be a mechanism of accountability that addresses who the receives the bodies, and that they comply with public health issues. In New York, there was a scandal recently about in stolen body parts. In response, Senators Charles E. Schumer and Patrick Leahy have introduced a bill, The Safe Tissue Act (S. 2609); but it does not, in Mr. Seely's opinion, go far enough to protect individual rights and public safety, and is limited in scope.
Mr. Seely suggested that ACOT recommend that Congress adopt a better proposal that will really address the problem. The suggested committee recommendations are to:
Dr. Migliori asked if this subject is part of ACOT's mission, and if there is any impact from illegal/illicit traffic on the available organ pool. Mr. Seely responded that it is appropriately part of ACOT's mission. His organization gets many calls from members of the public who are outraged about body tissue abuses. Some people have gotten rid of their donor cards as a result of these incidents. People do not differentiate between transplant centers, tissue facilities, and these unregulated entities. Ms. Conrad agreed, and reported that, as an OPO director, she gets calls weekly from people who want to donate whole bodies and all she can do is refer them elsewhere. There is a lack of information about how the bodies are used, the consent processes, and assessing good standards.
Mr. Seely proposed that ACOT could ask the IOM to look at this issue. Then the appropriate groups can shape legislation based on these findings. Dr. Sollinger stated that a strategy for proceeding will be developed and presented.
Jade Perdue, Division of Transplantation
Ms. Perdue presented on the Division of Transplantation (DoT) activities and ways to improve the number of organs donated and transplanted. Under NOTA, there is a new amendment that the Secretary can make grants to increase donation and recovery rates. There are currently three grant programs that fund projects around social enhancement of donation, OPO/hospital accountability through best practices, and clinical interventions (CIOP). CIOP does not support certain types of programs because HHS seeks interventions that can be immediately directed to the outpatient area.
Eleven three-year grants have been funded and it's hoped there will be three to five projects funded in FY07. DoT staff recently met with NIH staff to discuss grants management and found that the Institutes have longer project periods (4-10 years) and offer multiple opportunities to apply. DoT will start to offer technical assistance mid-year to grantees and hopes to work with NIH on forwarding promising projects for future funding of implementation of best practices.
Future opportunities include:
DoT seeks feedback from ACOT on ideas for areas of funding that will have the best impact and for suggestions about the most important step DoT can take to determine the focus of the CIOP.
Dr. Low stressed that anything ACOT can do to encourage this work will be appreciated and helpful. Dr. Sollinger asked if the DoT funds are available to most transplant professionals, and Ms. Perdue described the distribution processes used for the request for proposal (RFP). He suggested that a technical assistance session could be held at the upcoming World Transplant Congress (July 23-27). Dr. Bridges suggested that the OPOs are the most appropriate entities for the funding. In the clinical transplant community, not everyone knows how to formulate a question and create a study. Technical assistance can help these individuals write a grant and submit it, and DoT provides this.
Mr. Frieson suggested working with faith-based groups, as churches have huge health fairs that reach thousands of people. (His denomination's national meeting had a health fair attended by 40,000 people). The Government could fund materials to be distributed to these groups.
Dr. Mary Ganikos described a new DoT grant program to assist States that do not have a statewide organ donor registry and those States that do have a statewide donor registry which do not have enrollment capability through the motor vehicle licensing offices to develop and implement, in collaboration with all OPOs with service areas in that State and representatives of the eye and tissue banks in that State, a statewide registry of residents who wish to be an organ and tissue donor.
James Burdick, Division of Transplantation
Dr. Burdick presented past recommendations from ACOT. Recommendations have been made on the subject of education, the Breakthrough Collaborative, reimbursement policies among HRSA and CMS, medical examiners, and disparities in transplant rates. He reported in greater detail on the most recent recommendations (starting with #36) and updated the group on the progress to date. Dr. Rosenzweig asked for a written record of the recommendations and their implementation. Dr. Burdick promised to distribute this.
Laura St. Martin, Division of Transplantation
Dr. St. Martin noted that organ transplant-transmitted infections are rare, but can have serious outcomes. The goals of the reporting systems are included to identify all affected recipients in order to assess their condition and intervene with care; to remove all donor materials that have not been transplanted from the pool; to help investigate incidents; and to prevent future incidents.
OPTN/UNOS Policy 4.0 was revised and approved after public comment in 2004. It created a list of diseases and medical conditions to be communicated to the transplant center, if known to be present in the donor. Dr. St. Martin described mechanisms to implement the reporting system as well as the OPO and OPTN responsibilities. The OPTN will forward a final report from the OPO to HRSA. To manage the reporting process, the Disease Transmission Advisory Group has been created as a subcommittee of the OPTN/UNOS Operations Committee. It has an evolving role but its tasks include reviewing current disease transmission reporting policies, developing disease reporting forms, reviewing case reports, and recommending revisions to the OPTN/UNOS Policy 2.0 and 4.0.
There is also a Center for Disease Prevention and Control (CDC)-led project, which grew out of a June 2005 workshop on organ and tissue safety. Priorities were developed at this workshop that included the need for clear mechanisms for adverse event reporting, a notification algorithm, etc. While organ and tissue mechanisms may be created, the mechanisms should be able to communicate and share information between them. In 2005, the CDC issued an application to fund a Transplant Transmission Sentinel Network to do this, and the 3-year cooperative agreement was awarded to UNOS. UNOS has formed an alliance with many relevant organizations (i.e., AOPO, AATB, EBAA, AST, and ASTS) to do this work. The Network is in early stages but will hold a meeting on June 6, 2006.
Dr. Bridges asked if the information to be collected from OPTN caser report forms will go into the SRTR or other database. Dr. St. Martin commented that it's yet to be determined where the data will be housed. Staff is currently meeting with transplant centers about the need for the data collection and its use. Dr. Zhu commented that it's important to have a clear plan for data collection and analysis. Dr. Matthew Kuehnert, Assistant Director for Blood Safety, CDC, expressed the CDC's excitement about the effort and seeks ACOT's comments on the effort.
Hans Sollinger, Chair, ACOT
Dr. Sollinger recounted ACOT's history, which began with former Secretary Donna Shalala and grew out of the allocation battle. He recommended that new ACOT members should receive training how the process works and how recommendations get developed and promoted. He also suggested that introductions be made for everyone in the room so new members can learn who is who.
Proposed ACOT Recommendations for the Secretary to be addressed:
Dr. Sollinger thanked those individuals offering comments and adjourned the meeting.
The next meeting of the ACOT will be held on November 2-3, 2006.