Should All Living Kidney Donors Receive Donor Health Insurance? - Ethical Guidance for Evaluating Policies and Actions that Provide Financial Benefits to Living Organ Donors

The National Kidney Registry (NKR) is a voluntary network of 86 transplant centers in the United States. NKR supports living kidney transplants using novel computer algorithms to facilitate exchanges for patients where an intended donor and recipient are either incompatible (by ABO blood group or HLA sensitization), or poorly HLA matched.¹ Many such mismatched pairs are connected in a chain to ensure that all intending kidney donors end up donating and all recipients receive compatible organs. Often such chains are started by a non-directed donors who come forward to donate to someone they do not know for altruistic reasons.² Since 2008, NKR has facilitated over 600 chains started by non-directed donors, with over 2800 patients receiving kidney transplants.^{3, 4} It is presently the policy of the NKR to provide donor insurance to all non-directed living donors who initiate kidney paired exchange within its network.^{2, 5} This insurance contains life insurance, disability insurance, and coverage for any injuries or complications not covered by the donor or recipient’s insurance.^{2, 5}

The policy takes effect when the donor leaves home to travel to the donation site, and terminates one year after any post-donation complications. It is meant to provide coverage for any losses that may be incurred through donation and not covered by other insurance policies, including travel accidents, disability, or loss of life. Medical complications are defined using the exact Medicare definition, and must be a direct result of the donor surgery. The medical complications expense benefit is $250,000 with a $5,000 deductible. Accidental death and dismemberment is for one year and provides up to $1 million of coverage for accidental deaths and dismemberment. The temporary disability benefit pays $100 per week up to a maximum of $1,500. The permanent disability benefit pays $5,000 per month up to a maximum of $250,000. It is a similar insurance program that is offered by the Living Donor Organ Network through member centers. The insurance costs about $550 per donor, which is paid by the NKR.^{2, 5}

The idea for provision of such insurance to all living donors has developed from initial work done by the South Eastern Organ Procurement Foundation (SEOPF).^{6, 7} SEOPF tracked the outcomes of living donors and extended optional insurance to cover complications to participating centers in the early 2000’s, at the cost of $550 per donor.^{6, 7}The decision to apply this non-directed donor benefit was made by the Medical Board of the NKR after careful consideration; now called the Donor Protection Program.

The NKR is considering a policy change to include a wider scope for its potential living donors. The suggestion is to extend donor insurance to all living donors who donate through the NKR, rather than just to non-directed donors. Central ethical questions include whether extending insurance to all NKR donors could be considered an unethical valuable exchange or unreasonable inducement to donate, or whether such insurance would constitute unfair inducement for donors to work through the NKR rather than through other transplantation programs. Given these potential concerns, can it be ethically supported to extend donor insurance and prioritization for future transplantation to all NKR living donors? This analysis will tease out the impact of this proposed policy change within the NKR, and suggest an ethical framework for use by other transplant centers or networks that may consider similar policy changes.

In transplantation, we are concerned with fairly distributing a scarce resource among many persons in need. We are also concerned with the interests and welfare of donors, the interests of the public, and fair stewardship of this scarce resource. To balance these various interests and to determine rules for distribution, a utilitarian approach to distribution is often utilized. Utilitarianism states that right actions (or policies) are those that lead to the greatest good for the greatest number of people. That is, policies are set to ensure that the scarce resource provides the greatest benefit to the greatest number of affected patients. This forms the basic foundation for grounding various ethical commitments and goals in transplantation. Even if one holds to another ethical approach or theory, this framework can still be recognized as applicable and foundational to transplantation.

In Medical Ethics, we are often focused on obligations owed by the clinician to the individual patient. Commonly applied Medical Ethics frameworks reflect this. For example, deontology is an ethical approach that says ethical rules describe duties and obligations clinicians owe to their patients. One such approach is that ethical rules may be derived from the inherent worth and dignity of the patient as a person. The Kantian idea of respect for persons has been very influential in Medical Ethics, and may be used to derive ethical rules and duties owed to the patient because clinicians respect the patient as a person and do not merely regard a patient as an object. Such rules include respecting the patient’s right to direct their own medical care and make their own decisions, refraining from deception or dishonesty, helping patients to the best of one’s ability and skill, and the like. Another well-known ethical framework is the principles framework. It recognizes four principles that describe the ethical commitments of clinicians within the clinician-patient relationship. The clinician should provide benefit, avoid harm, and respect autonomy, while also being concerned with justice. These frameworks generally focus on what is owed to the individual patient. The clinician has obligations to serve the interests of the individual patient as described by these moral rules or principles.

There may therefore appear to be a tension between commonly applied frameworks in medical ethics and the utilitarian framework we use in this analysis. We maintain that these are compatible, given the unique relationships and resource limitations that constrain transplant centers. We argue that even the deontologist or principle-based ethicist will on reflection acknowledge the validity of the utilitarian distribution framework that will be used as basis for this analysis.

The deontologist and principlist are concerned respectively with rules and principles that govern patient-practitioner relationships and protect the interests of the individual patient. However, when it comes to transplantation of scarce human organs, we are confronted with many patients who are competing for said organs, and living donors whose interests must also be protected. In trying to secure and protect the interests of individual patients when deciding how to distribute this scarce resource, the deontologist and principlist will try to serve the interests of each individual patient fully as required by their Medical Ethics frameworks, but will fall short because of the restricted nature of the resource. What we end up with is a utilitarian type distributive system, which seeks to serve the interests and welfare of all those competing patients and donors to the maximal degree possible. It allows the clinician to fulfill obligations owed to the most patients and to the greatest extent possible. The utilitarian guiding principle used in this report will be that transplant policies should seek to maximize the interests and welfare of the most people, including the kidney recipient, the donor, the program and its professionals, and the public.

The transplant center must serve the interests of the most patients and donors possible to the maximal extent possible, given the inherent resource-limitations in transplantation. From this ethical basis, two ethical principles can be stipulated regarding protection of living donors. In contemporary clinical practice these principles are widely accepted in the transplant community, even if they are not explicitly stated, and are part of the guiding principles of transplant programs.

Authors usually distinguish between compensation and financial incentives as different forms of payment to living donors.^{12, 13} Compensation is usually thought of as money paid to make up for a loss or to reimburse costs. This could include reimbursement of travel expenses or hospitalization costs.¹³ Incentives are financial benefits given to encourage donation, and does not focus on merely replacing what was lost or reimbursing costs associated with donation.^{12, 13, 14}

There is an ethical and legal distinction between compensation and incentives as defined above. Legal and ethical norms tend to support compensation; financial payments for donation related costs are permitted by American law.^{13, 15} Incentives can be more ethically complex and problematic, and appear to be inconsistent with American jurisprudence.¹⁵ Financial incentives are explicitly forbidden in the NOTA legislation which regulates transplantation. The law does allow financial payments to cover “expenses of travel, housing, and lost wages incurred by the donor”.¹⁵ Financial incentives may therefore place transplant programs and donors at legal risk. This would have substantially negative effects for said transplant programs, their patients and donors, and cannot be ethically supported under present legislation.

Apart from the issue with present legislation, there are generally four arguments offered to show why financial incentives are thought to be ethically problematic.

Extending donor insurance to all donors clearly provides a financial benefit to donors. The insurance provides coverage for possible complications and harms directly associated with the act of donation. It is therefore an avenue for managing possible donation associated harms and losses that are not financially provided for in another way. The goals of donor insurance therefore seem onsistent with removing disincentives to donation, and ensuring that donors are as far as possible no worse off for donating.

The insurance policy costs $550 per donor, and as such is not an extraordinary amount, nor is it paid directly to the donor. Rather, an insurance benefit is provided that would only cover donation related complications. The potential for unreasonable inducement seems quite small. Insurance is an effort at harm mitigation and reduction of financial loss, rather than providing valuable exchange for the organ. Given these considerations, it does not appear as if there is any risk for creating a business transaction or placing a price tag on a kidney.

The risk of exploitation of the vulnerable appears minimal, as those who are poor will not be financially better off after donation. The policy is meant to remedy donation related risks and losses, and not offer financial inducement. It may replace financial losses, but the insurance does not generate new income. In addition, the usual process for donor evaluation will remain, which includes an additional set of safeguards against exploitation. In particular, the Independent Donor Advocate, a required participant in the living donor evaluation and informed consent process at all transplant centers, will be present to monitor possible exploitation. It therefore seems unlikely that donor insurance would lead to exploitation of vulnerable and marginalized patients.

One possible concern some may raise is that availability of donor insurance through the NKR may provide incentive for donors to work with NKR rather than other paired exchange networks who do not offer such insurance. This concern does not hold up to scrutiny, since donor insurance is aimed at removing donation disincentives and mitigating donation related losses. If one transplant program offers an injury or loss management program when others do not, it is not

unfair or unethical for donors to prefer that program. For example, if one transplant program introduces innovative surgical procedures that have evidence based lower complication rates and/or better outcomes for donors, it is very reasonable that donors would choose that program. On the contrary, one can argue it would be incumbent on other transplant programs to consider implementing similar procedures if they are shown to improve donor outcomes. Similarly, if the NKR implements a program that aims at removing disincentives and mitigating donation related risks, it would be incumbent on other programs to consider such practices.