Engaging Living Kidney Donors in a New Paradigm of Postdonation Care

[Clark]

http://onlinelibrary.wiley.com/doi/10.1111/ajt.13524/abstract

Personal Viewpoint
Engaging Living Kidney Donors in a New Paradigm of Postdonation Care
K. A. Newell1, R. N. Formica2 andJ. S. Gill3,*

DOI: 10.1111/ajt.13524
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

Abstract
Recent studies have highlighted the need for better understanding of the long-term health outcomes of living donors. Barriers to establishment of a dedicated long-term donor follow-up data system in the United States include infrastructure costs and donor retention. We propose providing all previous and future living donors with a lifelong health insurance benefit for the primary purpose of facilitating acquisition of health information after donation as an alternative to establishment of a dedicated donor follow-up data system. Donors would consent to allow collection and analysis of their medical data, and continuation of insurance coverage would require completion of regular health assessments. The extension of health insurance would be analogous to the established practice of paying people for participation in a research study and would provide a mechanism to engage donors in a new paradigm of postdonation care in which donors are actively involved in their own health maintenance. Rather than acting as an inducement for donation, providing donors with the ability to easily contribute information about their health status represents a practical strategy to acquire the long-term medical information necessary to better inform future generations of living kidney donors.

[Clark]

http://onlinelibrary.wiley.com/doi/10.1111/ajt.13526/full

Editorial

Lifetime Insurance Benefit for Living Donors: Is It Necessary and Could It Be Coercive?
E. M. Gibney*
DOI: 10.1111/ajt.13526
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

Living donors who develop kidney failure or other serious complications give great pause to the transplant community. These donors remind us that despite our most conscientious efforts at screening, informed consent, and advice on health behaviors, we struggle to ameliorate small but meaningful risks to each individual. This unease motivates many professionals who have pursued donor research and advocacy.
Newell et al have presented “a new paradigm of postdonation care” in the form of a tradeoff of annual data submission and health screening for enrollment in Medicare or lifetime insurance benefit. This is for “the primary purpose of facilitating acquisition of health information” [1]. The authors are established experts, and their viewpoint is endorsed by the American Society of Transplantation Board of Directors. However, we should examine their position with careful scrutiny.

An important concern with this proposal is that the moral problem of living donors lacking access to affordable health insurance has changed since the Affordable Care Act (ACA) passed in 2010. In 2010, 18% of living donors were uninsured [2]. Since the first open enrollment in 2013, more than 14 million Americans gained insurance and the numbers of uninsured young people are dropping substantially each year [3]. While we do not know whether the number of uninsured donors is dropping as well, the requirement that eligible U.S. residents add coverage or pay a penalty should allay the concern for a large population of uninsured donors.

The second and perhaps most important problem with the proposal is the provision of a valuable lifetime benefit in exchange for donation and data submission. To alleviate concerns for the restriction of “valuable consideration” for organ donation, the program is likened to a research payment. In contrast, typical research payments are designed to compensate for time and discomfort without being coercive. The time course and potential value of this benefit would far exceed typical thresholds for standard research payments and could violate the National Organ Transplant Act (NOTA). For example, the average age of U.S. living donors is 40, with approximately 25 years of premiums before reaching Medicare eligibility [4]. Currently, a typical yearly premium for a single person is $5000 to $6000, with family premiums averaging over $15 000 per year (multiple sources). This would indicate a minimum value of the average benefit being $125 000 (i.e. $5000 for 25 years), with costs being potentially much higher in the case of younger donors, inflation, or increases in premiums over time. NOTA specifically allows “reasonable payments associated with the removal, transportation … or the expenses of travel, housing, and lost wages incurred by a donor… .” The concept of trading a lifetime insurance benefit puts the author's proposal in conflict with NOTA pending a revision of the law.

The authors state that the “requirement for submission of data is not unique” and compare it to submission elements in the current ESRD program. The ESRD data submission is a unique one-time submission on the two-page CMS 2728 form that includes basic clinical data such as creatinine level, hemoglobin, albumin, presence of a fistula, cause of ESRD, height, weight, and demographic data. It allows a patient to receive the ESRD benefits without a requirement for annual visits, and no decision-making body revokes the benefit based on measures of patient compliance.

Is extended data collection likely to help? Secondary analysis has contributed important recent information. In particular, Muzaale et al linked U.S. donors to CMMS ESRD data, finding that donors have an increased risk of ESRD compared to matched healthy controls, with lifetime prevalence of ESRD still well below unmatched general population risks [4]. The absolute magnitude in increased risk is small but noteworthy. The low number of events in a particularly healthy population would make measured improvements in donor outcomes difficult and markedly expensive.

There are myriad other questions to be addressed, including cost, impact on access to care (if Medicare), and how the benefit interacts with workplace or family insurance policies. And what is the threshold for nonadherence to the voluntary data submission and who decides when a donor loses the benefit? The authors also point out the flaws in our current 2-year data collection system, which already has well-documented trouble maintaining high rates of donor follow-up. Any system that increases time from donation could exacerbate these problems.

In short, the idea of changing the paradigm of donor health data acquisition requires additional consideration. The need for donor health insurance has been diminished by the ACA, the potential value of lifetime insurance coverage could be coercive and could violate the intent of NOTA, and the potential impact on donor outcomes is unproved. To improve this proposal, the authors and proponents should more clearly outline the potential costs, should consider conflicts with NOTA or work on revisions to the legislation, and remove the requirement for donors to submit their data to maintain insurance as it would be practically impossible to enforce. Also, beyond the endorsement of the AST Board of Directors, input of key constituents is needed: membership, the transplant community, and donors themselves.