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The effect of state legislation and federal policies supporting living donors on living kidney donation rates in the United States is unknown. We studied living kidney donation rates from 1988 to 2006, and we assessed changes in donation before and after the enactment of state legislation and the launch of federal initiatives supporting donors. During the study, 27 states enacted legislation. Among states enacting legislation, there was no statistically significant difference in the average rate of increase in overall living kidney donations after compared to before state legislation enactment (annual increase in donations per 1 000 000 population [95% confidence interval] 2.39 [1.94–2.84] compared to 1.68 [0.89–2.47] respectively, p > 0.05). Among states not enacting legislation, there was a statistically significantly greater annual increase in overall donation rates from 1997 to 2002 compared to before 1997 when federal initiatives commenced, but there was no growth in annual rates after 2002. State and federal legislation were associated with increases in living-unrelated donation. These findings suggest that although existing public policies were not associated with improvements in the majority of donations from living-related donors, they may have had a selective effect on barriers to living-unrelated kidney donation.
The need for kidney transplantation in the United States has risen rapidly over the past decade, outpacing slow growth in numbers of available donors. Although efforts to recover greater numbers of deceased donor organs through the Organ Donation Collaboration Initiative (1,2) (in which known best practices for improving deceased donor organs have been spread among the largest hospitals in the United States) have had moderate success, living donors have consistently comprised a very large proportion (40–50%) of donated organs in recent years (3). However, living-related and unrelated kidney transplantation, which yield comparable-to-superior clinical outcomes compared to deceased kidney transplantation (3,4), remain underutilized.
The great need for donated organs has prompted a variety of broad-scale efforts to enhance donation rates (5), including the implementation of limited compensation for living organ donors. In addition to the National Organ Donor Leave Act of 1999 (6), which provides additional paid leave for federal employees who are living organ donors, several states have implemented legislation to support living donors. In 1998, Colorado became the first state to enact legislation mandating the use of paid leave for living organ donors for up to 2 days for government employees (7). Since that time, legislation has sprouted in other states offering varying types of support for living donors, including paid or unpaid leave for extended time periods as well as tax benefits (8–42).
Potential living organ donors in the general public are concerned about both medical (such as the potential for complications) and financial (such as the length of uncompensated time spent away from work) aspects of donation (43,44). In addition, potential transplant recipients who are concerned about the financial implications of donation are hesitant to approach potential donors (45,46). The intent of currently enacted legislation and federal initiatives is to overcome such disincentives to living donation by providing government and/or employer support for donors’ physical recovery and by minimizing financial losses as a result of donation. However, it is unclear if well-meaning public policy has had an effect on living kidney donation rates. Therefore, we performed a national study to assess differences in living organ donation rates among persons residing in states with and without legislation to support living organ donors.
Our study design was a series of cross-sectional analyses of living kidney donation rates from 1988 to 2006 in the continental U.S. We used publicly available data from state legislatures, the United Network for Organ Sharing, the U.S. Census Bureau, the Area Resource File, and the U.S. Renal Data System (USRDS). We estimated annual rates of living kidney donation for each state, and we assessed differences in overall, related and unrelated rates of donation between states that enacted legislation and states that did not enact legislation. We also examined the background association of (i.e. secular trends) federal initiatives begun in 1997 pertaining to living organ donation with donation rates.
For our independent variable, we identified states that enacted legislation for living organ donors by searching information published by the United Network for Organ Sharing, the National Conference of State Legislatures, and LexisNexis using keywords ‘organ donation’, ‘organ donor’, and ‘bone marrow donor’ (47–49). We included only legislation that was active from May 18, 1998, the earliest date of relevant legislation, until December 31, 2005 (7,8–42). We did not include legislation enacted in 2006 because we sought to have at least 1 year follow-up for states enacting legislation in 2005. We categorized legislation authorizing employers to provide donors with paid leave from work as ‘paid leave’, legislation offering donors tax deductions or credits for donation as ‘tax benefit’, and legislation providing donors with unpaid leave from work as ‘unpaid leave’. We categorized other forms of legislation (e.g. recommendations or encouragement of paid leave) as ‘other’.
For our dependent variable, we obtained the total number of living kidney donations from donors residing in each continental U.S. state during 1988–2006 from the U.S. Organ Procurement and Transplant Network (OPTN) (administered by the United Network for Organ Sharing under contract with the U.S. Health Resources and Services Administration), which performs administrative functions related to organ allocation including collecting and managing scientific data about organ donation and transplantation (50). Data on all U.S. organ donations and transplants are collected directly from hospitals, histocompatibility (tissue typing) laboratories and organ procurement organizations (51). We used population statistics for adults age 18–75 in each continental U.S. state from 1988 to 2006 from the U.S. Census Bureau (52,53).
A variety of factors, including patient demand for living donation, availability of deceased donor kidneys and provider supply could potentially confound any observed relation between legislation and donation rates in each state. For example, states with more physicians able to perform transplant surgery could have greater living transplant rates. We, therefore, ascertained whether rates of physicians and surgeons, the rate of deceased kidney donation or the demand for donation were different among states with versus without donation. We obtained data on the prevalence of end-stage renal disease (ESRD) during 1988–2005 for each state from the USRDS Annual Data Report (54). Because ESRD incidence and prevalence data were not available for 2006, we extrapolated data based on rates of increase in incidence and prevalence of ESRD prior to 2006. We obtained data from the 2006 Area Resource File (a compilation of publicly available data from over 50 sources, including the American Medical Association, the American Hospital Association and the Centers for Medicare and Medicaid Services on health care professions, facilities and utilization) to obtain information on prevalence of all physicians and specialist surgeons in 1988 and 2005 as well as transplant surgeons in 2005 (data available for 2001–2005 only) for each state (a measure of provider supply) (55). We used data from the U.S. OPTN to ascertain rates of deceased donation in each state during 1998–2006 (56). To assess the need for kidney donation in each state during each year, we calculated the ratio of kidney donations-to-ESRD prevalence in each state for each year. Because many of the types of legislation applied only to state or federal employees, we also ascertained whether the number of potential beneficiaries of enacted legislation varied among the states. We obtained data on the prevalence of state and federal employees in each state from the Compendium of Public Employment: 2002, a compendium of local, state and federal government employees produced by the U.S. Census Bureau (57).
We compared characteristics of states enacting versus not enacting legislation in bivariate analyses. To estimate donation rates for each study year, we divided the number of adult living kidney donations in each state by the number of adults age 18–75 in each state for each year during 1988–2006. We assumed the proportion of eligible donors relative to the donation rate would be similar in all states. We report living kidney donation rates as the number of living kidney donations per 1 000 000 persons in each year.
We performed a series of cross-sectional analyses over time by calculating aggregate mean living kidney donation rates for all states from January 1, 1988, to December 31, 2006. For all individual states, we calculated mean donation rates and mean annual change in donation rates during the entire study period. For states enacting legislation during the study period, we calculated mean donation rates and mean annual change in donation rates before and after the year of legislation enactment. We used linear spline functions to estimate the relation between time (in years) of legislation enactment and change in living kidney donation rates in a piecemeal linear function, with straight lines representing the discrete periods for all states (individually and collectively) with legislation. To provide a graphical representation of differences in donation rates in the presence versus absence of state legislation, we projected hypothetical donation rates for the hypothetical scenario in which states would not have enacted legislation, basing projections on the rate of increase in donations before legislation was enacted. To assess the potential for secular trends, particularly the association of federal initiatives with state donation rates, we used linear spline functions assessing the rate of change in donation in states with legislation and in states with and without legislation before or after 1997, when the first relevant federal initiatives commenced. Because overall donation rates plateaued after 2002, we also assessed differences in donation rates after 2002 compared to before 2002 for states with and without legislation. We assessed whether donors not emotionally or biologically related to recipients might be more likely to respond to legislation supporting donors when compared to emotionally or biologically related donors (who might donate regardless of support available at state or federal levels) by performing a separate analysis to assess the potential association of legislation among related (defined as parents, children, siblings, spouses and significant others designated as ‘life partners’ in UNOS data) compared to unrelated (all others) donors. In addition, we assessed whether changes in living kidney donation rates associated with state legislation or temporal changes in living kidney donation rates could be related to deceased kidney donation rates during the study (e.g. increases in deceased donation might be associated with declines in living kidney donation rates) by performing a sensitivity analysis in which models used in main analyses additionally adjusted for the annual deceased kidney donation rate in each state. We performed all descriptive and comparative analyses using STATA Statistical Software (Release 9.0, Stata Corporation, TX).
From May 18, 1998 to December 31, 2005, 27 states enacted legislation to provide support for living organ donors. A majority of states (22) enacted legislation mandating paid leave for donors, while fewer enacted legislation mandating tax benefits (9), and unpaid leave (3). Two states enacted legislation encouraging paid leave (Figure 1). Only one state enacted legislation prior to 1999. After 1999, there was a dramatic increase in the number of states enacting legislation, with a majority of legislation enacted after or during the launch of major federal initiatives (including the National Organ and Tissue Donation Initiative (1997) (58), enactment of the Organ Donor Leave Act (1999) (6), Gift of Life Donation Initiative (2001) (59) and enactment of the Organ Donation and Recovery Improvement Act (2004) (60) to enhance organ and tissue donation.
A detailed description of states’ legislation and federal initiatives is contained in the Appendix. Among the 22 states mandating paid leave, most mandated paid leave for state government employees, while a minority (3) mandated paid leave for both state and local government employees. Most states (19 of 22) mandated paid leave for up to 30 days. Nearly half (12) of these states mandated leave for donation be used as a supplement to donors’ existing paid leave for illnesses. Of the three states mandating unpaid leave, two of three mandated leave be afforded by private employers as well as the state government. The length of mandated unpaid leave was longer than paid leave mandated by states, and ranged from 70 to 168 days. Of the nine states mandating tax benefits for donors, two provided for $10 000 tax credits, while the remainder mandated $10 000 tax deductions (Table 1).
The median time states’ legislation had been enacted prior to the end of the study period (December 31, 2006) was 2.5 (inter-quartile range: 2–5) years. States enacting legislation had statistically significantly greater increases in prevalence of ESRD from 1988 to 2005 when compared to states not enacting legislation. However, there were no differences in states enacting legislation versus those not enacting legislation according to state population size, incidence or prevalence of ESRD in 1988 or 2005, prevalence of physicians or surgeons with specialty training in 1988 or 2005, number of state or federal employees in 2002, rate of deceased kidney donation in 1988 or 2006 or Census regions (Table 2).
The mean living kidney donation rate in the continental U.S increased during the study period (11.3 (95% Confidence Interval (CI): 9.9 to 12.8) donations per 1 000 000 population in 1988 to 33.5 (95% CI: 30.1 to 36.9) donations per 1 000 000 population in 2006). The mean proportion of donations from unrelated donors among all states rose dramatically during the study period (ranging from 1.5% of all donations in 1988 to 26% of all donations in 2006). Prior to 2002, the mean (95% CI) annual increase in all living kidney donations was 1.6 (1.5 to 1.8) per 1 000 000 population per year. After 2002, however, annual increases in donation plateaued (mean annual increase in donations 0.6 (−0.5 to 0.6) donations per 1 000 000 population per year. Annual changes in donation varied among the individual 48 states, with all states demonstrating an average annual increase in living kidney donations during the study. Minnesota, Maine and North Dakota experienced the greatest average annual increases in living kidney donations (mean (SD) increases of 2.9 (0.8), 2.8 (2.2) and 2.8 (2.5) donations per 1 000 000 population, respectively), while Oklahoma, Arkansas and South Carolina experienced the smallest average annual increases in living kidney donations (mean (SD) increases of 0.3 (0.6), 0.5 (0.7) and 0.6 (0.7) donations per 1 000 000 population, respectively).
Over the entire study period, the unadjusted mean overall living kidney donation rate for states with enacted legislation was not statistically significantly greater than the mean donation rate for states with no legislation enacted (average difference (95% CI) in donation rate 2.4 (−2.0 to 6.8) donations per 1 000 000 population greater in states with legislation enacted versus states with no legislation enacted, p > 0.05). The rate of change in overall donations during the entire study period was also not statistically significantly greater in states enacting legislation compared to states not enacting legislation (difference in average annual increase (95% CI): 0.06 (−0.44 to 0.33) donations per 1 000 000 greater in states enacting (versus not enacting) legislation, p > 0.05). There was no difference in the need for kidney donation in states with legislation enacted versus states without legislation enacted at baseline (mean (SD) donations per prevalent case of ESRD: 0.015 (0.009) versus 0.014 (0.006), respectively, p > 0.05) or during the entire study period (mean (SD) donations per prevalent case of ESRD: 0.015 (0.001) versus 0.015 (0.001), respectively, p > 0.05).
Among the 27 states enacting legislation during the study period, mean overall donation rates and mean annual changes in overall donation rates before and after enactment of legislation varied. While 25 of the 27 states experienced statistically significant average annual increases in donation rates before legislation was enacted, only three of the states experienced statistically significant average annual increases in donation rates after legislation was enacted. A majority (n = 22) of the states enacting legislation experienced no growth in donation rates after legislation was enacted, and two states experienced statistically significant average annual declines in donation rates after legislation was enacted (Table 3). Among states not enacting legislation, mean donation rates before and after 1997, when federal initiatives to enhance living organ donation commenced, varied. While 11 of the 21 states not enacting their own legislation experienced statistically significant annual increases in donation after 1997, 10 of these states experienced no statistically significant average annual increase in donation rates after 1997 (Table 4).
In analyses accounting for length of time state legislation had been enacted, the types of legislation present and the incidence and prevalence of ESRD in each state, there was no statistically significant difference in the average rate of increase in overall living kidney donations after states enacted their first legislation when compared to the rate of increase in donations prior to states’ enactment of their first legislation (average annual increase of 1.68 (95% CI: 0.89–2.47) donations per 1 000 000 after enactment of first legislation compared to average annual increase of 2.39 (95% CI: 1.94–2.84) donations per 1 000 000 prior to enactment of first legislation, p = 0.06) (Figure 2A). The association of state legislation with living-related and unrelated donors differed. There was statistically significantly less growth in living-related kidney donations after states enacted their first legislation when compared to the rate of increase in donations prior to states’ enactment of their first legislation. In contrast, there was a statistically significantly greater average rate of increase in living-unrelated donations after states enacted their first legislation compared to the rate of increase in donations prior to states’ enactment of their first legislation (Figure 2B). Results of main analyses did not change when accounting for states’ deceased kidney donation rates during the study.
Analyses assessing secular trends due to national initiatives (which commenced in 1997) to enhance living donation revealed that states with legislation experienced similar annual increases in overall living kidney donation rates before 1997 and from 1998 to 2002, but they experienced no statistically significant annual increase in donation rates after 2002. States without legislation experienced a greater mean annual increase in donation rates from 1997 to 2002 compared to before 1997 but experienced no statistically significant annual increase in donation rates after 2002 (Figure 3A). Changes in the annual increase in donation rates after 2002 compared to the annual increase from 1998 to 2002 were no different between states with legislation and states without legislation (change in annual increase in donation among states with legislation −2.28 (95% CI: −3.29 to −1.27) donations per 1 000 000, and change in annual increase in donation among states without legislation −2.44 (95% CI: −3.43 to −1.46) per 1 000 000, p > 0.05). Secular trends in donation differed among living-related and unrelated donations. Both states enacting legislation and states not enacting legislation experienced no statistically significant change in the average annual rate of increase in living-related donations from 1997 to 2002 compared to before 1997. After 2002, both states enacting legislation and states not enacting legislation experienced statistically significantly different changes in living-related donation rates (states enacting legislation experienced a plateau in annual growth while states not enacting legislation experienced a decline in annual growth). In contrast, both states enacting their own legislation and states not enacting legislation experienced a statistically significantly greater annual increase in the rate of living-unrelated donations from 1997 to 2002 compared to before 1997, but states also experienced statistically significantly less growth in living-unrelated donations after 2002 compared the period from 1997 to 2002 (Figure 3B). Results of main analyses did not change when accounting for states’ deceased kidney donation rates during the study.
In this 19-year national study of living kidney donation rates, we found, after accounting for the length of time legislation was enacted and the incidence and prevalence of ESRD in each state, that increases in living-related kidney donations (which comprised a majority of all donations) were no greater after the institution of state or federal public policies compared to before policies were instituted. In contrast, rates of living-unrelated donation were associated with state and federal policies, suggesting policies may selectively decrease barriers to living-unrelated kidney donation. These findings inform ongoing efforts at state and federal levels to enhance living donation and may provide insight to avenues for future improvement in living organ donation rates.
A great deal of attention has been devoted to identifying mechanisms through which disincentives to living organ donation can be overcome. Debate regarding which types (if any) and what magnitude of incentive for living donors are most appropriate from legal and ethical standpoints has been a prominent component of this dialog (61–69). Many have rejected arguments for payment to donors (e.g. tax credits or regulated organ sales), citing their potential to exploit persons of less socioeconomic means, the possibility of violating the National Organ Transplant Act (which forbids the transfer of organs for valuable consideration in transplantation) and the possibility of minimizing the value of what many consider an altruistic gift (61,63,69–71). However, proponents have proposed modest rewards that provide reimbursement for expenses of travel, housing and lost wages incurred by donors (which would not necessarily enrich potential donors, and would not leave donors more physically and financially worse-off as before their donation) as potentially acceptable (61,68). The current state legislation we studied has been modeled after this latter approach, providing some protection from financial losses associated with donation (by protecting lost wages and providing arguably minimal financial relief through benefits in state income taxes) and by allowing time for donors’ convalescence. Additional policies at the federal level currently undergoing evaluation provide reimbursement for subsistence expenses incurred by donors (including financial support for travel, lodging and meals) (72). Our study suggests interventions, as currently formulated, are only associated with living-unrelated kidney donation and not associated with sustained improvements in the larger numbers of living-related donations and therefore overall living donation rates.
Although recent studies suggest the U.S. public views paid leave and reimbursed medical expenses for living donors favorably (73), little is known regarding the magnitude of compensation or reimbursement needed to have an effect on donation behaviors. A regional study demonstrated potential living donors are very sensitive to financial risks associated with donation (43). We are aware of no studies assessing the potential effects of offering differing magnitudes of compensation for potential living donors on donation rates and we are aware of no studies assessing the potential effect of varying types of legislation on persons of low financial means. Current legislation addresses only employed persons or persons with enough income to benefit from a $10 000 tax credit or deduction, and therefore offers no provisions to persons who may be unemployed or with minimal incomes (who are likely face greater financial hardship when considering living donation). In addition, most legislation mandating paid leave is limited to state employees who represent a very small proportion (1% to 4%) of the total population in each state, therefore severely limiting the potential impact of legislative efforts. While our findings suggest these current policies are associated with an increase in living-unrelated donation rates, further work is needed to identify whether legislation has had any untoward effect on access to living kidney transplantation and willingness to donate among segments of the population such as those with less financial means.
Public initiatives are intended not only to improve the donation experience for those who have already chosen to donate but also to raise awareness among the general public regarding the need for living donation. Although some initiatives are aimed at a narrow audience (i.e. paid leave mandated for mostly state and local government employees), awareness raising campaigns may have an effect on potential living-unrelated donors who have limited knowledge about the need for kidney donation. The presence of legislation may also more significantly relieve potential unrelated donors’ perceptions of barriers to donation when compared to the majority of donors who are emotionally or biologically related to recipients. Barriers to living-related donation vary and include potential transplant recipient attitudes (including concern regarding risks to donors’ health and finances and their perceptions of ESRD) (74–76), potential donor knowledge (77,78) or attitudes (43,43,79) and family attributes (including poor patient, family and physician communication and family cohesion) (74,80). Interventions performed at the level of individual patients, families and health care providers may prove more effective in enhancing rates of living-related donation than interventions implemented at the population level. Our results do not provide guidance as to whether legislative efforts should be abandoned entirely. Although these policies are not associated with improvements in living-related donation rates, other studies that quantify the value of existing public initiatives (or their accessibility to the public) in addressing potential donors’ concerns are needed (81).
The observed decline in growth of living-related donation rates after states enacted legislation should be interpreted with caution. Both states enacting legislation and states not enacting legislation experienced a statistically significant slowing of growth in donation rates after 2002, suggesting an unrelated temporal phenomenon affecting living-related donation rates in the continental U.S. Further research is needed to understand reasons for slowed growth in donation rates despite a growing need for donations after 2002 (3). It is possible the success of recent efforts to enhance rates of deceased donation, including the Organ Donation Breakthrough Collaborative by the U.S. Department of Health and Human Services Health Resources and Services Administration, has drawn attention away from efforts to improve rates of living donation by lessening perceived pressures regarding need for living kidney donation (1,2). However, sensitivity analyses accounting for deceased kidney donation rates in each state demonstrated no change from main findings, suggesting this was not the case.
Limitations of this study deserve mention. First, although we categorized legislation into discrete groups, there was variation among states in terms of the content of legislation (e.g. some states legislated less than 10 days paid leave for employees while others provided for up to 30 days paid leave) and the targets of legislation (e.g. some states legislated paid leave for state employees only while others provided paid leave for private sector employees as well). The effect of legislation on willingness to donate could vary according to specific implementation patterns and among specific subpopulations (e.g. persons of different demographic or financial backgrounds). Despite this variation, only two states stipulated less than 30 days paid leave, limiting our ability to perform sensitivity analyses to test the association of variations in legislation with donation rates. Similarly, the small number of states providing either tax deductions or tax benefits limited our ability to test differences in associations of these tax benefits with donation rates. Second, our study does not account for other local factors that might influence increases in donation such as the presence of transplant centers with active recruitment efforts for living donation. Third, many states enacted legislation after 2000, limiting our ability to assess a long-term association of legislation with donation rates. Fourth, our study was not able to identify underlying reasons for tremendous growth of donations in some states (such Minnesota) but not in others. It is possible that growth could be attributed to a variety of factors, including the availability of transplant surgeons, the need for transplantation in states, greater activism on the part of donation proponents or patient advocates, cultural influences or policies instituted on a local level (e.g. individual companies might voluntarily implement donor leave policies). While we did not observe differences in the number of transplant surgeons or the need for transplantation in states with versus without legislation, we were not able to measure other potential factors that could affect donation rates locally. Finally, growth in living-unrelated donation may have been affected by other factors (e.g. improvements in immunosuppression, establishment of stranger donor programs) during the study period. Notwithstanding these limitations, to our knowledge, this study is the first to rigorously assess of the association of both state and national policies with living kidney donation rates in the United States.
In summary, existing state and federal policies were not associated in improvements in donation rates among the majority of living kidney donors who were related to transplant recipients but were associated with improvements in living-unrelated kidney donations. Further work is needed to assess the degree to which current policies overcome barriers for all donors and to assess whether other policy interventions are associated with improvements in all types of donation.
This work was supported in part by Health Resources and Services Administration contract 234–2005-370011C. The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
The work was funded by Robert Wood Johnson Harold Amos Faculty Development Program (Dr. Boulware); Grant#K23DK070757 from the National Center for Minority Health and Health Disparities and the National Institute of Diabetes and Digestive and Kidney Diseases (Dr. Boulware); Grant #K240502643 from National Institute of Diabetes and Digestive and Kidney Diseases (Dr. Powe)