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This paper was prepared for discussion at the November 2006 meeting. It does not represent the official views of the Council or of the U.S. government.

Staff Working Paper

Organ Transplantation: Potential Policy Recommendations

By Sam Crowe, PhD, and Eric Cohen

Since February 2006, the Council has been engaged in an in-depth inquiry into the ethical and policy dimensions of organ donation, procurement, allocation, and transplantation. This inquiry has been conducted through ten Council sessions, staff meetings with numerous experts, extensive outreach to key organizations, and multiple staff working papers. It is clear that the Council has a unique contribution to make to current debates and will publish a report of its findings in the spring of 2007.

As with its previous reports, the heart of the Council's contribution will be in the realm of the ethical, with a series of core chapters on the ethics of deceased donation, living donation, and organ allocation. The report will subject various perspectives in the current debate to a probing inquiry; it will explore the ethical obligations and ethical dilemmas that shape current practices; and it will try to elucidate the deeper human goods and attendant imperatives that shape organ donation, procurement, allocation, and transplantation-from the meaning of the human body to the nature of human death to the aspirations and limits of medicine. The result should be an ethical analysis that every member of the Council can "own."

The Council's work is situated amid widespread concern about the current system of organ procurement and allocation, as the gap between organ demand and organ supply continues to widen. Some experts and organizations are interested in controversial-some would say "radical"-reforms: from promoting donation after uncontrolled cardiac death to enacting a policy of presumed consent to permitting and promoting organ markets. Motivated by a desire to serve the public good, each of these potential reforms deserves to be considered and analyzed on its moral merits. The Council's report will surely offer such analysis in full, giving every position its due and acknowledging the disagreements that exist both in the country and among Council members.

As the Council explores these potential reforms, it will also describe-and, where appropriate, defend-the moral framework that governs the current system of organ donation, procurement, allocation, and transplantation. These governing principles include the following:

  • that organ transplantation is a good that serves health and saves lives, which should be facilitated by public policy;
  • that being a donor is a personal decision requiring voluntary consent, a consent that cannot be presumed;
  • that families, especially the families of the newly deceased, should have their needs and wishes respected, especially during the final moments of a loved one's life and in the first moments of mourning;
  • that physicians and medical institutions have an obligation to ensure that organ donation is safe, free from coercion, and, in the case of deceased donors, only begins once the donor is rightfully declared dead;
  • that everyone on the organ waiting list should be treated fairly, allocating organs according to principles of equity and utility that apply universally to everyone;
  • and that organ donors should be true donors, providing organs not for pay or profit but as gifts of the body to those whose bodies are failing.

This staff working paper explores a series of focused policy recommendations that work within the general ethical framework of the current system. These recommendations envision reforms that serve one or more of the moral goals of the current system, without violating any of the principles integral to its overarching moral framework. These recommendations are offered as potential recommendations; they are intended to spur and direct Council discussion and to assess where the Council might pledge its support. For those recommendations that do seem to have broad support, the staff will develop them further and in greater detail.

There are nine potential recommendations, which are organized into four thematic categories:

The first category includes four policies that aim at protecting the health and well-being of the living donor and his/her family and at easing the economic burden of living donation, especially for those with limited resources. This includes providing all donors with a legally protected unpaid leave of absence from work; providing donors with tax credits to cover the direct costs associated with donation; providing donors with life and disability insurance to protect donors who die or become debilitated due to complications from donation; and providing donors with supplementary health insurance to cover the incremental additional health expenses connected to donation.

The second category includes one policy recommendation that aims at improving the care of transplant recipients by making Medicare immunosuppressive drug coverage for organ recipients lifelong. 

The third category includes two policies that would better serve the aims of equity and utility in organ allocation: first, by taking measures to mitigate geographical inequities in organ allocation, and second, by reforming the criteria that govern kidney allocation. 

The fourth category includes two policies that aim at expanding the supply of available organs within the moral framework of the current system. This includes the promotion of ethically responsible criteria for planned donation after cardiac death; and the promotion of paired and list donation, understood as forms of creative gifting. 

Category #1: Ensuring the Well-Being of Living Donors

Unpaid Leave of Absence for Organ Donation

On April 28, 2005, some members of the House of Representatives introduced a bill called the "Living Organ Donor Job Security Act of 2005." The bill proposes to amend the Family and Medical Leave Act of 1993 to include a provision for organ donation. 

The 1993 Act declared that employees who have worked for at least twelve months for a specific employer and who have worked for at least 1250 hours during that twelve month period may take an unpaid leave of absence for twelve work weeks for a few specific conditions. These conditions include the birth and care of a baby, the adoption and care of a child, the care of a sick family member, or the recovery of the employee from serious illness. 

Only certain employers are covered by the 1993 Act. All public service employers, all primary and secondary schools, and all employers who have fifty or more employees for at least twenty of the calendar work weeks must allow their employees to take this form of leave if needed. Those private employers who regularly have less than fifty employees are not bound by the law to permit this form of leave of absence.

The Living Organ Donor Job Security Act would amend the Family and Medical Leave Act by including organ donation as one of the eligible reasons for taking a legally protected leave of absence. The bill lists six specific donation-related activities that the leave would cover: tests to determine if the person is medically suitable to be a donor, evaluations to determine if the person has the requisite mental health to be a donor, pre-transplantation medical services, post-operation services, travel during the total process, and recuperation time. The bill does not specify the length of the leave of absence that would be granted, but presumably the leave would be the same as the other conditions already permitted.

It is worth noting that all federal government employees, government employees of some states (Delaware, Maryland, Missouri, Ohio, Utah, and Virginia), and government employees of the District of Columbia currently may take thirty days of paid leave to be organ donors. The Living Organ Donor Job Security Act would supplement this leave for these federal and state employees by two months. But the bill neither recommends that public sector donors should be paid during the extra two months, nor proposes that private sector employees should be paid at all.

The Council could recommend passage of this or a similar bill. Such a law would build on the well-established practice of allowing employees to take leave from work to perform life-giving or care-giving activities, without requiring that employers pay employees who are not working. Such a law would ensure that fear of job loss is not the reason that a willing donor does not donate, without unduly burdening private employers with mandates they may not be able to fulfill. It thus balances, in a subtle way, the competing needs of employees and employers.

In the context of organ donation, the law could be made more or less specific-for example, by setting different periods of leave for different types of organ donation, or by making clear that the period of permissible leave can be broken up to account for pre-donation and post-donation activities. But the overriding moral principle is clear: living donors should not fear for their jobs in making the decision to donate, and in this limited way, the public sector can protect living donors from this concern.

2. Tax Credits to Compensate the Direct Costs of Donating

Section 274e of Title 42 of the U.S. Code states the following: "the term 'valuable consideration' does not include the reasonable payments associated with.the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ." This law in effect permits reimbursement for the financial costs incurred during the donation process, but it does not support any particular means of payment. A few states (Arkansas, Georgia, Iowa, Minnesota, New Mexico, North Dakota, Oklahoma, Utah, and Wisconsin) have created reimbursement programs, but as of now there is no federal policy to compensate donors for their expenses.

In the spring of 2005, a few members of the House of Representatives presented a bill entitled the "Living Organ Donor Tax Credit Act of 2005." The bill proposes to amend the Internal Revenue Code of 1986 to include a nonrefundable personal tax credit for the financial costs of living donation. The credit would cover un-reimbursed costs related to the process of donation, offering a tax credit up to a maximum amount of $5,000. Eligible expenses include the costs of transportation, lodging, and any wages lost during the transplantation process. The credit would only be given if an organ is actually removed.

The moral aim of such a policy is to reduce the financial impediments to being an organ donor. For most people, living without pay and paying for the travel and lodging expenses connected to donation is a serious burden, making donation difficult and in some cases impossible. A policy of reimbursement for expenses, using tax credits, would help generous donors to be generous by easing the direct financial costs of their act of organ gifting. Such reimbursement is not an incentive to donate or a form of payment for donating, but a way to ensure that donation does not lead to economic problems or even temporary impoverishment for donors.

A policy of tax credits has certain specific advantages: it employs an existing tax mechanism as the means of reimbursement; it works within existing law on organ transplantation, requiring no alteration of the valuable consideration statute; it focuses on specific expenses rather than offering a general reimbursement; and it both protects organ donors and promotes organ donation in a way that is entirely consistent with the ethical framework that governs the current system. Taken together, such a policy would provide assistance to those who "give the gift of life" by giving of themselves, quite literally, to help another in need. And, inasmuch as it expands the number of donors and thus reduces the number of patients on dialysis, the economic positive might outweigh the economic cost of the program.

The Council could recommend passage of a version of the tax credit law, either in the form already proposed in Congress or with some modification. As for potential modifications, it could recommend that the size of the tax credit be either expanded or reduced. It could recommend that eligibility for the tax credit depend on the personal or family income of the donor, thus tailoring the program to assist donors most in need. Or it could recommend that the size of the tax credit depend on personal or family income (i.e., a larger credit for less wealthy donors, a smaller credit for more wealthy donors). Whatever the specifics, however, the overriding principle would be that the public sector has a compelling moral interest in helping generous people be generous; just as charitable donations are tax deductible, we could make the financial costs of being a living organ donor reimbursable, especially for those who stand to bear the greatest economic burden from being a donor.

3. Limited Life and Disability Insurance for Living Donors

Like all surgery, living donation carries certain risks. Kidney donation has a morbidity rate of 1-10% and a mortality rate of 0.03%; partial liver donation has a 10% morbidity rate and 0.2% mortality rate. While the risk is relatively low, the possibility that the donor may become disabled or die is also real. For donors with dependents, the fear of leaving their families in economic turmoil could become a reason not to donate, and in those cases of mortality or debilitating morbidity, poor families most of all could be left in financial ruin.

To ameliorate some of the economic risks associated with living donation, the Council might recommend publicly-subsidized life and disability insurance targeted especially to those with limited means. The available insurance would only cover mortality and morbidity that result directly from the act of donation, both in surgery and due to post-operative complications. Such a policy would not be an inducement to donate, but rather a form of protection for donors and their families, allowing them better to cope in the event that the worst imaginable scenarios become tragic realities.

In practical terms, the policy could be structured in various ways. It might be similar to the insurance policies offered to members of the armed forces, with donors paying a small fee to opt into the system and the federal government paying out the policies in the case of disability or death. Such policies could be available either to all living donors or to all donors with annual incomes and net worth beneath a certain eligibility threshold. There could be a single-rate fee or the fee could be mean-tested to reduce or eliminate the cost for the poorest donors. Eligibility could be tied to routine follow-up care, thus requiring that donors care for themselves if the public sector is going to help care for them and their families. Alternatively, the law might offer tax breaks or other incentives to entice private life and disability insurance companies to offer insurance to living organ donors at a reduced price. 

Regardless of its ultimate form, this policy recommendation would probably require that the existing statute governing organ transplantation be amended to clarify that the limited form of life and disability insurance proposed here is not a form of valuable consideration. Such a policy recommendation, however, would not shift the moral framework that informs the existing law: namely, that organ donation should be an act of generosity, not a form of commerce. Rather, such a policy would remove a potential barrier to donation-fear of impoverishing one's family-and it would ensure that donor families are not left in economic ruin in the tragic event that their family provider can no longer provide for them.

4. Supplementary Health Insurance for Living Donors

Even in the vast majority of cases, when organ donation proceeds without major complications, there are often additional healthcare expenses and minor complications incurred by donors, including expenses that extend beyond the term of coverage by the organ recipient's insurance policy. And, yet again, it is poorer donors, especially those with high co-payment or high-deductible insurance policies, that stand to bear the greatest additional burden.

To address this problem, the Council might recommend offering publicly-subsidized supplementary health insurance for living donors to cover the incremental, out-of-pocket costs connected to the act of donation. This recommendation would be offered as a form of care for donors intrinsically connected to the act of donation, and it would be a way to ensure that donors take care of themselves-most notably, that donors go for all of their necessary follow-up visits, rather than avoiding extra doctor visits to avoid extra costs. Such a program could also be tied to expanded follow-up studies of living donors. Like the reimbursement program recommended above, it could take the form of tax credits for extra medical costs incurred because of donation. It could be available to all donors or targeted to donors below a certain income-level.

A more expansive and more costly recommendation would be to make all living donors eligible for public health insurance, perhaps through the Medicare system. The trouble with offering public health insurance to all living donors, however, is that it risks becoming an inducement to donation rather than a form of proper care for donors. Some individuals, lacking quality health insurance or worried about the high cost of health insurance, might donate in order to become eligible for publicly-provided healthcare. By contrast, a system of supplementary health coverage, focused only on covering those costs and complications related to the act of donation, would ensure that the existing system of organ gifting is not undermined.

Such a targeted policy of supplemental insurance could be combined with greater legal protections to guarantee that living donors are never adversely affected in the private health-insurance market because they were donors-such as prohibiting insurance companies from treating donation itself or complications due to donation as cost-increasing pre-existing conditions.

For donors without health insurance, the policy could require transplant centers to investigate whether the potential donor is eligible for Medicaid, and if so, to facilitate enrollment. For those donors without insurance who are not eligible for Medicaid, the program could cover the entire cost of care related to the act of donation, either by reimbursing the donor or by paying the transplant center directly.

Whatever specific form a policy of supplemental health coverage ultimately takes, the principle guiding such a recommendation would be clear: there is a moral obligation to ensure that living donors are cared for. To permit and even encourage organ donation while leaving donors at undue risk because they lack healthcare coverage is morally irresponsible. As with life and disability insurance, such a policy would probably require an amendment to existing law. This amendment would clarify that providing limited supplemental health coverage is a form of care for living donors inextricable from the act of donation, not a form of valuable consideration or an inducement to donate. And, once again, this shift in the law does not involve an alteration in the moral aims that govern the law: namely, ensuring that organ donation is always an act of generosity, motivated by beneficence rather than the pursuit of profit.

Category #2: Improving Care for Transplant Recipients

5.  Comprehensive Immunosuppressive Drug Coverage

To combat organ graft rejection, transplant recipients must take immunosuppressive drugs for the rest of their lives. These drugs are fairly expensive, costing on average $1,000 per month. Private health insurance can defray much of the cost, but for those who do not have private insurance, for those with only minimal coverage, and for those with limited financial means, the out-of-pocket cost for these drugs can be prohibitive. Many of those who would not be able to afford the drugs on their own qualify for Medicare drug benefits-specifically, those who are 65 and over, those who are legally considered disabled, and those who have end-stage renal disease. The problem is that for the third class of patients-those whose Medicare eligibility is tied to their end-stage renal disease-Medicare only covers the cost of the immunosuppressive drugs for three years.

In addition to the time limit on drug coverage, there are two other significant limitations that affect Medicare eligibility for drug coverage for transplant recipients. First, if a transplant recipient is not eligible for Medicare at the time of the transplant, then the recipient cannot receive immunosuppressive drug coverage through Medicare even if the patient becomes of Medicare age or disabled. Second, if the patient receives a transplant in a hospital that is not Medicare approved, then the recipient cannot later receive immunosuppressive drug coverage even if the patient would otherwise qualify for it.  

Currently, the Senate has a bill at the committee level called the "Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2005." The bill would change the law by striking the three-year time limit on Medicare drug coverage for transplant recipients who were previously part of Medicare's end-stage renal disease program. It would also provide immunosuppressive drug coverage for all individuals covered by Medicare, regardless of whether or not they were eligible for Medicare benefits when they had their transplant and regardless of whether or not the transplant took place in a hospital approved by Medicare.

The Council could pledge its support for such a policy, which makes both economic and moral sense. First, lifetime immunosuppressive drug coverage is less expensive than the alternative in most cases. If a recipient's new kidney fails (this situation only applies to kidney failure, but most of the organs transplanted are kidneys), then Medicare will cover the cost of future dialysis and another kidney transplant. Dialysis costs on average $4,000 per month, while a transplant operation costs roughly $100,000. Compared to these costs, the $1,000 per month for immunosuppressive drugs is minuscule.

Second, premature transplant failure, when caused because the recipient stops taking immunosuppressive drugs, is not only expensive but tragic and wasteful. To continue with the kidney example, the normal lifespan of a transplanted kidney is on average 8 to 12 years. When recipients who cannot afford the immunosuppressive drugs begin losing their transplanted kidneys at 4 to 5 years, these recipients lose on average 3 to 8 years of a good functioning kidney, and often are added once again to the waiting list. Given Medicare's large role in caring for those with end-stage renal disease through its dialysis program, providing lifelong immunosuppressive drug coverage seems like a wise investment: ensuring that the sick take care of themselves, and preventing the avoidable return to dialysis for patients who stop taking their medications because they cost too much.

Category #3: Improving Organ Allocation

6.  Mitigating the Role of Geography

Utility and equity are the central moral ideals that govern the existing system of allocating organs to those on the public waiting list. The practical application of these moral ideals is a complicated, ongoing process, rooted in both certain historical realities about how organ transplantation took shape in the United States and in certain clinical realities about the viability and compatibility of human organs.

Both procuring and allocating organs originated as local practices, shaped by and directed to the needs of local and later regional communities. In 1984, the passage of the National Organ Transplantation Act by Congress signaled a new phase in the evolution of allocation policy: organ transplantation was embraced as a medical innovation of national-rather than local or regional-significance, as was the need for a more ordered, principled approach to securing and distributing the precious resource of human organs. Subsequent legislative and regulatory initiatives, by Congress and the Department of Health and Human Services, have served to articulate and to buttress three ethically relevant norms: first, in organ allocation, the operative sense of community should be the national (rather than local or regional) community; second, organs should be allocated in ways that achieve their best, most efficient usage; and third, beyond effective usage, the most important criterion in allocating human organs should be patient need.

In recent years, there has been laudable progress in the effort to bring the system of allocation into conformity with these norms. For example, reforms in the allocation algorithms for livers and lungs have tilted the balance of criteria toward urgency of patient need and, as a result, there are now fewer deaths on the waiting list for these organs and geographic disparities have been lessened. Nonetheless, so-called "accidents of geography" remain; where a person is registered as a transplant candidate continues to be a potent factor in determining whether one ultimately receives an organ or not. To the extent that organ viability is critical to the efficient, effective use of these scarce resources, geography will remain a constraining factor in the allocation of human organs, especially hearts. Yet the geographical inequities that persist in current practice are not dictated entirely by the demands of utility. In some cases, the most worthy recipient, judged by criteria of physiology, age, medical urgency, or waiting time, is not getting an available and viable organ, or is waiting much longer for such an organ, simply because they live in the wrong place.

Clearly, there are significant challenges and obstacles that mark the path toward greater geographical equity in the system. Moreover, the original and now traditional practice of procuring and allocating organs within the same local community is deeply entrenched, in part, because it has served legitimate community needs-and served them well. For sound ethical reasons, however, the nation has embraced geographical equity as the most defensible basis for allocating human organs. In deference to this ideal, the Council could urge UNOS and the Department of Health and Human Services to continue to explore and institute reforms that would ensure that allocation serves the needs of patients, unfettered by accidents of geography.

7.  Greater Equity and Utility in Kidney Allocation

At present, the factor weighed most heavily in kidney allocation, beyond physiological compatibility between donors and recipients, is waiting time. While this criterion serves equity in an obvious sense, giving waiting time such a high importance in allocation risks undermining utility and equity in other crucial ways. To begin with, it means that the value of receiving an organ is diminished by waiting for years on dialysis in order to receive it; the result is that we are getting fewer quality years out of the organs we transplant. We are also transplanting organs to a comparatively older rather than younger set of patients with renal failure. The Council could recommend reforming the kidney allocation system to give greater relative weight to other factors. Such factors might include:

Age of Recipient: Already, we give priority in kidney allocation to pediatric patients. The Council could recommend expanding this principle to benefit comparatively young, non-pediatric patients-for example, by assigning points for age in a sliding scale, such that as age increases, the points in the algorithm assigned for age decrease.

Age Relationship of Donor and Recipient: Under the current allocation system, organs from 20 year old deceased donors are sometimes transplanted into 60 year old recipients. The Council could recommend developing a policy requiring that donors and recipients be of a certain proximate age: for example, a 50 year old on the waiting list could be eligible for organs only from donors within a decade of his or her age (i.e., 40 to 60 year olds).

Long-Term Benefit: The Council could recommend giving greater relative weight to donors who stand to benefit the longest from receiving a kidney transplant.

Net Benefit: The Council could recommend giving greater relative weight to donors who would likely receive the greatest net benefit from a kidney transplant compared to continuing with dialysis. Such a net benefit calculation could also take into account the comparative quality of life on dialysis versus life after transplantation.

Each of these proposed reforms of course invites its own criticisms and problems-including the problem of shifting from the current system to a reformed system. Any system of allocating a scarce resource stands to benefit some and thus disadvantage others. But there are sound reasons to conclude that the current system is not the only way, or the best way, to serve the goals of utility or equity in kidney allocation, and that it will serve these goals even less well as the size of the waiting list continues to grow. In particular, by giving some relative preference to the young, a reformed allocation system would attempt to ameliorate some of the inequities of nature (such as getting end-stage renal disease in one's twenties) in addition to maximizing the benefits received from transplanted organs; it would not discriminate against the old, but recognize that in allocating a scarce resource, we need to do so based on some moral understanding of whose claims are the weightiest.

Category #4: Encouraging Ethically Responsible Ways to Increase the Organ Supply

8. Encourage Ethically Responsible Donation after Cardiac Death (DCD)

In certain, well-defined clinical circumstances, doctors and family members decide that continued life-sustaining treatment no longer benefits the life the patient still has. Some of these patients are potential organ donors, and the number of cases of planned donation after cardiac death (commonly called "controlled" DCD) has been slowly increasing in recent years: in 1994 there were only 11 donations after planned cardiac death, whereas in 2004 there were 366. Those 366 deceased donations produced 689 kidneys, 233 livers, 47 pancreata, and 10 lungs. This expansion could become much larger if the large number of centers that do not have protocols in place for planned DCD are encouraged to develop them. The Council could recommend a morally responsible expansion of this practice-both to ensure that wherever it is done, it is done responsibly, and to encourage a morally sound way to increase the organ supply.

Donation after planned DCD should only be practiced within an explicit hospital policy framework governed by clear moral criteria. A morally sound hospital policy would include the following: (1) The decision to withdraw interventions must be made independently of the decision to donate. (2) Donors must receive the same end-of-life palliative care as non-donors. (3) The hospital should provide the potential donor's family with the option of being present when life support is withdrawn and, in general, take every measure to permit family and friends to say goodbye in a dignified way. In addition, families should not incur any additional costs related to donation. (4) Procurement teams must wait the recommended amount of time (2-5 minutes) after the permanent cessation of heart function before beginning the removal of the organs. (5) The medical staff overseeing withdrawal of interventions must not hasten the patient's death, even if the organs might become un-transplantable. (6) If patients do not die quickly enough to become donors, a procedure should be in place to return these patients to the intensive care unit to die in a peaceful and respectful way. In general, the desire to expand the practice of DCD procurement should not encourage hospitals to proceed without transparent policies in place that ensure consistent and ethical practice.

Several moral arguments can be marshaled in support of encouraging planned DCD.  First, it would increase the organ supply in a way that is entirely consistent with current ethical standards: the donors and/or the families freely consent to donation; the donors are dead before becoming donors; and every possible effort can be taken to respect the needs and wishes of the donor's family in the last moment of life and first moments of mourning. Second, it would extend the opportunity for individuals and families to donate in situations in which they are currently unable to do so. And third, establishing clear protocols for planned DCD would help to ensure that a bright line is maintained between those patients who are already dead by neurological criteria and those who are still alive though severely neurologically compromised. If DCD preparedness provides another responsible means for facilitating donation after death, then the temptation to use nearly dead patients as a source of organs should be diminished.

The Organ Donation Breakthrough Collaborative is actively working to help develop and spread ethically sound protocols for planned DCD. The primary thrust of the Collaborative's efforts aim at educating and training hospitals, organ procurement organizations, and transplant center staff. The Collaborative is also supporting research that aims at achieving higher transplantation success rates with organs procured after cardiac death by spreading information about better surgical techniques, better organ preservation, and better matching with potential recipients.

The efforts of the Collaborative are in sync with actions being taken by UNOS and other groups to provide incentives and requirements to hospitals to expand the practice of DCD. UNOS adopted a resolution in August 2006 to include in its bylaws a requirement that all participating organizations have a DCD protocol in place by January 1, 2007. The organizations that would be subject to this requirement include all organ procurement organizations and all transplant hospitals, where procurements also take place. The requirement would not force all potential donor hospitals to have protocols because the OPTN has no jurisdiction over these centers. A requirement to develop DCD protocols in every hospital is currently being considered by the hospital accreditation body, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). A Council endorsement of ethically responsible planned DCD could mean lending its weight to some of these efforts.

9.  Encourage Paired Donation and List Donation

Paired donation and list donation are creative forms of organ gifting, allowing living donors who are not biologically compatible with their intended recipients to work together with one another, or in conjunction with the public waiting list, to make donation possible in cases when otherwise it would not be. A paired donation generally involves two living donors and two intended recipients: Donor A gives to Intended Recipient B, and Donor B gives to Intended Recipient A. Paired donations can also occur among multiple pairs of donors and recipients. A list donation occurs when Donor A desires to give a kidney to Intended Recipient A who is not biologically compatible. Instead, Donor A gives a kidney to someone on the kidney waiting list, and in exchange Recipient A receives a compatible kidney from the list more quickly than if Donor A did not donate to the list. 

Paired donation and list donation can be combined and used together in what is called a "chain exchange." Chain exchanges, in their simplest form, entail two pairs (A and B) that do not qualify for paired donation, meaning that both donors do not match the recipients of the opposite pair. Instead, only the donor of pair A matches the recipient of pair B. In a chain exchange, the donor of pair A gives a kidney to the intended recipient of pair B, and the donor of pair B in turn gives a kidney to the general kidney list. The intended recipient of pair A then moves up the waiting list for kidneys.

Paired donation and list donation are not new ideas. Transplant surgeons in some centers have been doing them for the past few years. The first documented list donation occurred in 2001 at the New England Program for Kidney Exchange. There have been an estimated 55 list donations carried out in the United States. The Johns Hopkins' Comprehensive Transplant Center performed the first simple paired donation in the United States in 2001 and the first triple kidney donation in August 2003. In total, there have been an estimated 125 transplants using paired donations in the United States.

In February 2006, a few Senators introduced a bill called the "Living Kidney Organ Donation Clarification Act." The bill would clarify under law that paired donation and list donation do not involve the giving of kidneys for valuable consideration. The bill is currently with the Committee on Health, Education, Labor, and Pensions. 

Beyond clarifying the legality of these practices, there are two main ways that a policy promoting paired and list donation could be implemented. First, Congress could grant the OPTN extensive control over paired and list donation. The OPTN would then most likely create a national paired donation registry and clear rules to ensure that list donations do not unfairly disadvantage those who are already at the top of the waiting list, especially those with rare blood types. This approach would presumably bring many potential donors to the registry, and would unify the registry policy and living organ donation policy more generally.       

The second approach would be to provide federal assistance directly to transplant hospitals to help them to develop or to expand paired and list donation programs without OPTN interference. This option would include offering grants for paired donation registries to cover registry costs, such as the salary for transplant coordinators, public education expenditures, and ongoing research. This option would help private organizations to explore further the different ways of running patient registries without the bureaucratic oversight that would be part of the OPTN system.

The Council could both recommend passage of the Living Kidney Organ Donation Clarification Act and encourage the creation of expanded and ethically responsible national/local protocols for paired donation and list donation. Such a recommendation would help facilitate this creative form of gifting, allowing generous potential donors to become actual donors. Through these measures, the bonds of community could be both widened and deepened, binding individuals to one another through mutual acts of generosity. 

  - The President's Council on Bioethics -  
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