A policy proposal relating to transplantation of deceased donor organs into nonresidents of the United States was jointly sponsored by the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) International Relations and Ethics Committees and approved by the OPTN/UNOS Board in June 2012. The proposal followed prior acceptance by the Board of the definitions of “travel for transplantation” and “transplant tourism” and the introduction in March 2012 of revised data collection categories for transplant candidates who are neither citizens nor residents. The most important aspect of the new policy concerns replacement of the previous so-called “5% rule” with the review of all residency and citizenship data and the preparation of a public annual report. The new policy does not prohibit organ transplantation in nonresidents. However, the policy and public data report will ensure transparency and support transplant center responsibility to account for their practices. Since the adoption of the policy, the first 19 months of data show that less than 1% of new deceased donor waitlist additions and less than 1% of transplantation recipients were non-US citizen/nonresidents candidates who traveled to the United States for purposes of transplantation. By adopting this policy, the US transplant community promotes public trust and serves as an example to the international transplant community.
Ad Hoc International Relations Committee
Membership and Professional Standards Committee
National Organ Transplant Act
Organ Procurement and Transplantation Network
United Network for Organ Sharing
World Health Organization
At the June 2012 Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) board meeting a proposal to revise and reorganize the International Transplantation Policy (originally Policy 6.0 and recently renumbered Policy 17) was officially adopted and went into effect in September 2012 . This viewpoint describes how the adoption of the revised International Transplantation Policy is an important step to further public trust by providing increased transparency on practices related to travel into the United States for purposes of deceased donor organ transplantation.
The origin of the International Transplantation Policy begins with the National Organ Transplant Act (NOTA) of 1984 . NOTA called for a Task Force on Organ Transplantation that was convened in 1986, to make recommendations to the Secretary of the Department of Health and Human Services on elements of future OPTN policy. The issue of transplantation of foreign nationals was controversial even then, when the shortage of deceased organs in the United States was of a different order of magnitude than it is today. Foreign nationals were generally understood to be “nonresident aliens,” meaning non-US citizens who lived outside of the United States. After vigorous debate the Task Force recommended (, p. 8) that “nonresident aliens should not comprise more than 10% of the total number of kidney transplant recipients at each center” (emphasis added to note original focus on kidney transplantation). A sizable minority of the Task Force members entered a statement of exception to the effect that a kidney should not be offered to a nonresident alien unless another suitable US citizen recipient could not be found. The Task Force also recommended that “life-saving” extra-renal organs such as hearts and livers be offered for transplantation into nonresident aliens only if no other suitable recipient could be found.
After UNOS was awarded the OPTN contract it adopted policy based in part on the Task Force recommendations and gave the Ad Hoc International Relations Committee (AHIRC) the task of reviewing the activities of transplant programs whose proportion of nonresident alien recipients for any organ exceeded 10%. In 1994, the percentage was changed to 5% for all organs and remained unchanged until 2010. Because of the sensitive nature of the policy a clause (formerly Policy 6.2.5) was included entitled “Community Participation” stating that “each member center which lists nonresident aliens on its Waiting List should establish a mechanism for community participation and review of its candidate acceptance criteria.” No percentage for listing of nonresident aliens was included in this clause. The purpose of this provision was to provide some measure of transparency and public accountability. Yet no program that listed nonresident aliens ever actually established such a mechanism for community participation or was ever required to do so.
It is important to understand that NOTA specifically requires that only medical criteria be used in organ allocation. Accordingly, a dual list allocation system used by some countries (citizens and residents first) would be prohibited and the 5% “rule” did not prohibit transplant centers from waitlisting or transplanting more than 5% nonresident aliens. Rather, the 5% “rule” served as a threshold to trigger an audit. In this respect, the rule was much misunderstood by the transplant community. Since 1994 letters of explanation were requested and received by the AHIRC from those programs who exceeded 5% of nonresident alien recipients but no formal review, or detailed audit, was ever performed, and no program was referred to the OPTN/UNOS Membership and Professional Standards Committee (MPSC).
The consequences of the ambiguity and misunderstanding of the policy was such that some programs were unnecessarily fearful of listing and transplanting residents with unclear immigration status living in the United States while other programs listed and transplanted nonresidents who travel to the United States to receive a deceased donor organ transplant without consideration of the impact on, or attitude of, the community that they serve. The appropriate stewardship of the organ should include its local impact as well as broader implications. The transplantation of non-US residents at US transplant centers must also be seen in the context of the widespread international efforts by transplant professionals, national legislative authorities and the World Health Organization (WHO)  to counter transplant tourism. Central to this effort has been the widespread endorsement of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism , including the adoption of the definitions used in the Declaration by the UNOS Board in 2009. The concept of “transplant tourism” is defined in the Declaration as follows:
“Travel for transplantation is the movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation purposes. Travel for transplantation becomes transplant tourism if it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals and transplant centers) devoted to providing transplants to patients from outside a country undermine the country's ability to provide transplant services for its own population.” (emphasis added)
Defining “transplant tourism” to include travel for transplant that has the consequence of undermining the ability of a country to serve the transplantation needs of its own population firmly roots self-sufficiency as a core principle of the Declaration of Istanbul. The Declaration further elaborates on this point by stating that “jurisdictions, countries and regions should strive to achieve self-sufficiency in organ donation and transplantation by providing a sufficient number of organs for residents in need from within the country or through regional cooperation.” The call for self-sufficiency includes the concept that “treatment of patients from outside the country or jurisdiction is only acceptable if it does not undermine a country's ability to provide transplant services for its own population.” Self-sufficiency requires the accountability of governments and government agencies .
It is internationally recognized in the WHO Guiding Principles that transparency and openness to assessment is essential to an effective organ donation and transplantation system . In order for the United States to bring transparency to the transplantation practices that may implicate transplant tourism, the OPTN/UNOS Board of Directors, at its June 2011 meeting, approved revised data collection categories based on citizenship and residency status and a field to collect information indicating whether candidates who are neither US citizens nor residents traveled to the United States for the purpose of transplantation. The candidate's year of entry to the United States is also recorded. These data collection categories were implemented in March 2012. While adding any new data collection requirements can be viewed as burdensome to transplant centers, the addition of these few data fields is justified by the necessity of the system to be able to publicly account for where and to whom deceased organs in the United States are allocated for transplantation.
With this background, the changes to the Policy and corresponding data categories serve to facilitate accuracy of reporting of those individuals traveling to the United States for transplantation by simplifying the definition of residency status. Specifically, the revised Policy eliminates the immigration terminology (“alien”) and replaces it with the lay concept of residency. This was an intentional decision because the legal status of an individual's residence in the United States was considered directly relevant for the purpose of understanding transplant tourism into the United States. Rather, the simplified concept of residency is emphasized based on the Declaration of Istanbul definition of transplant tourism and the concepts of self-sufficiency. Residents of a country regardless of their formal immigration or government benefits status contribute to the deceased organ donor pool and therefore transplantation of such individuals does not undermine that country's self-sufficiency. In comparison, nonresidents are highly unlikely to become deceased donors in a country in which they do not reside. Transplantation of nonresidents, therefore, undermines a country's ability to meet the transplantation needs of its own residents.
Residency and citizenship status is self-reported by the transplant candidate, as it has always been, but may also be self-evident from other patient demographic information provided. It would be inappropriate to turn transplantation professionals into immigration officials by requiring candidates to produce passports, birth certificates or other legal documents for evaluation at the time of listing. While self-reporting has limitations, this is not a new practice as citizenship, race and other information have always been routinely collected this way. If there were reason to believe a transplant center purposely falsified its data, the matter would be considered a serious potential UNOS policy violation and referred to the UNOS MPSC for investigation.
In an effort to provide public transparency and accountability, the revised Policy replaces the 5% audit trigger with a provision that requires a review by the AHIRC of all residency and citizenship data relating to listings and transplants. The provision of any information over and above that which is already in the data collection elements is voluntary. The information collected by such review will enable the preparation of an annual report of these activities at member transplant centers, redacted of individual identifiers to protect patient privacy. Such a report will be made accessible to the general public and will enable a far better understanding of the nature, extent and circumstances of “travel for transplantation” into the United States.
It should be emphasized that the new policy does not prohibit or attempt to prohibit nonresidents from being wait-listed or receiving a transplantation. Such a prohibition would be contrary to the provisions of NOTA and would contravene a long tradition of providing compassionate care and access to US medical services for those in dire need who live elsewhere and do not have access to care in their home country. No attempt is made to use citizenship or residency status as a factor in organ allocation itself. The Policy does not seek to punish programs that list and transplant nonresidents or refer such programs to the MPSC.
Review of 22 months of data collected since implementation of the new categories in March 2012 through December 2013 reveals the following: Recipients of deceased donor transplantations who were identified as non-US citizens/nonresidents and traveled to the United States for purposes of transplantation totaled 141, comprising 0.3% of the deceased donor transplantation recipients during that time period . It is important to recognize that because these are new data categories, this is likely under-representative as patients who received a transplant during this time period but were listed prior to this time period would not have been categorized under the new data collection definitions. If the number of recipients recorded under the old definitions (“nonresident alien”) that received a transplant during that same time period and were added in, the total is 283 or 0.7%. The organ-specific data show that the number of recipients categorized as traveled to the United States for deceased donor liver transplantation is relatively higher during this time period than for other organs (see Table 1). Note that the recipient's country of origin is not currently collected or reported on.
|Organ type||Number of transplant recipients||Transplant recipients (%)||Number of transplant programs||Transplant programs (%)|
|Total||141||0.3||70 transplant programs at 42 transplant centers||8.5% of transplant programs at 16.8% of transplant centers|
In looking at the new waitlist registrations added during this same time period, a total of 413 candidates identified as non-US citizens/non-US residents traveling to the United States for the purpose of transplantation were added . This constitutes 0.4% of total new waitlist registrations during this time period. A higher number and percent age of these candidates are waiting for deceased donor liver transplantation (183 or 0.8%), followed by kidney (114 or 0.2%), then lung (43 or 1%) and heart (44 or 0.6%) .
Specific data by transplant center are available through the OPTN website and show a wide range of practice with many centers reporting no new waitlist registrations or transplantation of non-US citizens/non-US residents who have traveled to the United States for transplantation. Of those transplant centers with some reported activity in the new categories, only one was above 5% for actual transplants performed on non-US citizens/non-US residents who traveled to the United States for transplantation . That center performed only a single transplant into a non-US citizen/non-US resident who traveled to the United States for transplantation but due to low volume, it accounted for over 16% of the total transplant activity for that program in the applicable time period. New waitlist registrations for non-US citizens/non-US residents who traveled to the United States for transplantation during the 22-month time period were equally low with the range between 0 and 5.4% . A total of 22 transplant centers out of 248 listed more than five patients in the non-US citizens/non-US resident candidates in the traveled for transplantation category . Of those centers, there were 15 transplant centers (representing 6% of the centers in the United States) that listed 10 or more non-US citizen/non-US resident candidates in the traveled for transplantation category during the 22-month time period . This supports the observation that foreign patients travel to a small number of specific transplant centers in the United States for transplantation services. With the public reporting of this data, transplant centers are accountable to the public to assess the percentage of nonresident/noncitizen patients who have been listed or have undergone transplantation relative to the US residents/citizens waitlisted by that center.
In comparison, during this same time period, 47 or 0.3% of deceased donors in the United States were categorized as non-US citizens/non-US residents  although there are concerns of under-reporting in this category as neither residency or citizenship is consistently collected as a routine part of the donation process. This is roughly comparable to the percent of non-US citizens/non-US residents receiving transplantation and/or being added as candidates to the deceased donor waitlist. As a point of reference, during this same time period, deceased donors in the United States who were categorized as noncitizens but US residents comprised approximately 3.3% .
The enacted changes to the International Organ Transplantation policy (now Policy 17) may provide information to facilitate future policy-making but, most importantly, it effectively provides the US public with an enhanced degree of transparency of transplant practice that is fundamental to the maintenance of public trust. By doing so the US transplant community continues its long and honored tradition of providing service to the US public and exemplary leadership to the international community.
The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.