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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    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  | *This discussion paper was discussed at the February 2007 meeting. It is one of a series of papers prepared to aid the Council in its decisions about policy options in organ procurement, transplantation, and allocation. Each paper in the series is designed to facilitate and inform Council discussions and does not represent the official views of the Council or of the U.S. government.*
Caring for Living Donors and Transplant Recipients:               Five Policy Proposals Staff Discussion Paper **By Sam Crowe, PhD, and Eric Cohen**
With the passage of the National Organ Transplantation Act in 1984, the federal government began to regulate and, indeed, to promote organ transplantation as a social good. Since then, the federal government's role in overseeing the organ transplantation process has expanded-including ongoing efforts to increase the organ supply through national educational programs, to refine the organ allocation system in order to distribute organs more effectively and equitably, and to improve the regulatory oversight of hospitals to ensure that they provide safe conditions for both organ donors and recipients. 

Each of the five policy proposals presented in this essay offers a new way for the federal government to care for and protect living donors or transplant recipients. The first four proposals focus on improving the care of the organ donor. The first protects the living donor's job by granting the donor a twelve-week-long unpaid leave of absence from work in order to donate. The second lessens the financial burden of donation by offering the organ donor a tax credit to compensate for the direct costs of donating. The third proposal looks after the living donor's family by offering the donor limited life and disability insurance to be paid in the event that the donor dies or becomes disabled due to complications arising from donation. The fourth provides supplementary health insurance to living donors to ensure that they receive the proper medical care after donating. The fifth proposal aims at improving the care of the organ recipient by providing comprehensive immunosuppressive drug coverage to recipients in order to help guarantee graft success. These proposals, although not exhaustive, address many of the major challenges in the care of the donor and the recipient, as a more thorough account of each proposal will demonstrate. 

Before describing these proposals it is worth noting at the outset that there are arguments that might persuade the Council to withhold its support from them. First, by attempting to reduce the burden of organ gifting by expanding the federal government's role in caring for living donors, these policy proposals actually threaten to undermine the integrity of the act of gifting itself. By introducing money and other non-monetary forms of assistance into the process, even in the limited form of reimbursement for donor expenses or insurance in the case of donor morbidity or mortality, the generosity of the act of giving becomes tainted by the specter of compensation. Proponents of this position might argue that in its most authentic sense, a gift requires that one give without receiving anything in return. Although the aim of providing care for those involved in organ transplantation is admirable, the federal government could undermine the moral foundations of the organ donation system by offering new and valuable benefits to donors. 

Second, these policy proposals either cost too much and/or the public moneys used to fund them might be better spent on other projects, even within the domain of organ transplantation. Offering tax credits, life insurance, or health insurance to living donors and immunosuppressive drug coverage to transplant recipients will probably cost a considerable amount of taxpayer money, and with so many other healthcare problems (e.g., millions of Americans without basic healthcare, the actuality and threat of epidemics) and other challenges (e.g., homeland security, education) facing the nation, it would be irresponsible for the federal government to spend large amounts of public funds on a comparatively small problem. Moreover, some proponents of this position might argue, if the federal government decides to spend more on organ transplantation, the funds should probably be allotted to efforts to maximize the organ supply-especially in light of the fact that more Americans are dying each year due to organ failure than are dying because of graft failure or because of medical complications that arise from donating. 

These objections are weighty. The following will address them directly in order to offer the Council as strong a case for each proposal as possible. In addition to addressing questions of incentives and of costs, the following will draw and illuminate parallels between these proposals and current laws, especially to the degree that they provide precedents for enacting these proposals. **
**I. Unpaid Leave of Absence for Organ Donation****
On April 28, 2005, the "Living Organ Donor Job Security Act of 2005" was introduced in the House of Representatives. 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 living organ donation as one of the eligible conditions for taking a legally protected leave of absence. The bill lists six specific donation-related activities that such a leave of absence could 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 permitted, but one could presume that the leave would be the same as with the other conditions already permitted. 

It is worth noting that all federal government employees, government employees of some states (i.e., 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. The bill, however, 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 also would ensure that fear of job loss does not inhibit a willing donor's desire to 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. In any case, 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. 
**II. Tax Credits to Compensate for the Direct Costs of Donating****
Section 274e of Title 42 of the U.S. C ode 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." In effect, this law permits reimbursement for the financial costs incurred during the donation process, but it does not support any particular means of payment. A few states (i.e., Arkansas , Georgia , Iowa , Minnesota, New Mexico , North Dakota , Oklahoma , Utah , and Wisconsin ) have created reimbursement programs, but currently there is no federal policy to compensate donors for their expenses. 

During the 1 st Session of the 109 th Congress the "Living Organ Donor Tax Credit Act of 2005" was introduced in the House of Representatives. 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 practical aim of such a policy is to reduce the financial impediments to living organ donation. For most people, living without pay and paying for the travel and lodging expenses connected to donation are serious burdens, 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 of ensuring 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. In light of these advantages, 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 positives might outweigh the economic costs of such a policy. 

The Council could recommend passage of a version of the tax credit law, either in the form proposed in the House of Representatives or with some modification. As for potential modifications, the Council could recommend that the size of the tax credit be either increased 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. 
**III. Limited Life and Disability Insurance for Living Donors****
As with all surgical interventions, living donation carries certain risks. Kidney donation has a morbidity rate of 1 to 10 percent and a mortality rate of 0.03 percent; partial liver donation has a 10 percent morbidity rate and 0.2 percent mortality rate.**1**Thus, although the risks are relatively low, the possibility that a living donor may become disabled or die is real. For donors with dependents, the fear of exposing their families to financial risk or ruin is often a reason not to donate. 

To ameliorate or reduce the financial risks associated with living donation, the Council might recommend publicly-subsidized life and disability insurance targeted to those with limited means. The available insurance would cover only 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. 
**IV. 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 extending 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, who 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 costly recommendation would be to make all living donors eligible for public health insurance, perhaps through the Medicare system. The difficulty with this option is that such insurance could become an inducement to donate 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 receive care. 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. 
**V. Comprehensive Immunosuppressive Drug Coverage****
To combat 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.**2** 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 costs 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-whose Medicare eligibility is tied to 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. 

During the 109 th Congress the Senate considered the "Comprehensive Immunosuppressive Drug Coverage for Transplant Patients Act of 2005." The bill would change the law by removing 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 lend its support to 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.**3**Compared to these costs, the $1,000 per month for immunosuppressive drugs is minuscule. 

Second, when premature transplant failure is due to the cessation of immunosuppressive drug therapy, it is not only expensive but tragic and wasteful. To continue with the kidney example, the normal lifespan of a transplanted kidney is, on average, twelve years.**4** When recipients who cannot afford the immunosuppressive drugs begin losing their transplanted kidneys at four years, these recipients lose, on average, eight years in the "life" of a well functioning kidney, and often must, once again, join the waiting list. In light of Medicare's substantive role in caring for those with end-stage renal disease through its dialysis program, providing lifelong immunosuppressive drug coverage would be a wise investment: for it would ensure that the sick take care of themselves, and would prevent the return to dialysis by patients who stop taking their medications because of the costs. 

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FOOTNOTES
 1. See Matas, Bartlett, Leichtman, and Delmonico's "Morbidity and Mortality After Living Kidney Donation, 1999-2001: Survey of United States Transplant Centers" in *American Journal of Transplantation*, 2003, 3: 830-834. See also the National Institute of Health's notice number NOT-AI-05-006. This notice was released on October 29, 2004, by the National Institute of Allergy and Infectious Diseases, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Heart, Lung and Blood Institute, and the Health Resources and Services Administration. 

2. See the websites of the Transplant Recipients International Organization (TRIO) and the North American Transplant Coordinators Organization (NATCO). See also the Advisory Committee on Organ Transplantation's (ACOT) Recommendation 27. 

3. See Footnote 2. 

4. See the websites of Stanford Hospital , Legacy Health System, the National Kidney Federation, and Addenbrooke's Hospital. 

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