1. Proposed Revisions to Policy 6
Proposed Revisions to Policy 6.0 Transplantation of Non-Resident Aliens
Sponsored by the Ad Hoc International Relations Committee & the Ethics Committee

2. Core Problems of Current Policy 6.0
Policy 6.0 is misunderstood in the transplant community
Current data collected does not permit adequate evaluation of numbers of patients who travel to the US for deceased donor transplantation
Minimal public transparency
Programs find themselves sorting through immigration status based on current definitions
Programs may be unnecessarily hesitant to transplant non-resident aliens for fear audit

3. Goals of the proposal Immediate goals: Short term goal:
Align policy 6.0 with current transplantation environment and new data collection points
Collect data that will more accurately reflect the number of patients that travel to the U.S. for deceased donor transplant
Short term goal:
Provide public transparency of the wait-listing and deceased donor transplant of non-citizen/non-residents
Long term goal:
Asses the data to understand the scope of travel for deceased donor transplantation to the US and to inform future policy development

4. Proposed Modifications
New Definitions for Data Collection to simplify and focus on patients travelling to US for transplantation
resident / non-resident
Collect data and allow the Ad Hoc International Relations Committee to request additional information from transplant centers on listing and transplant of non-citizen/non-resident patients
Eliminate the “5% rule”
Public report of transplant center activity regarding listing and transplant by citizen and resident status
This audit of listings and transplants will enable the Committee to distinguish between non-US citizens/non-US residents who traveled to the US for transplant, and why, from those who are residents of the US.

5. New Non-US Citizen Definitions
6.1.1 (Non-US Citizen/US Resident) – A non- citizen of the United States, who is present in the United States, and for whom the United States is the primary place of residence.
6.1.2 (Non-US Citizen/Non-US Resident) – A non-citizen of the United States who is present in the US but who does not have the United States as his/her primary place of residence.
The goal in creating these categories is to focus on the category of patients who do not reside in the US and are travelling to the US for purposes of transplantation.
The proposal changes the current definitions by defining residency simply as whether the patient considers the US as the primary place of residence whereas currently the definition in 6.1 is based on legal immigration status. The Committees feel that this change is important given that the purpose in collecting such information is to evaluate the category of non-US citizen patients who travel to the US for transplantation, and to provide transparency regarding the listing and transplantation of these patients. Given that neither the OPTN nor its members are likely to have immigration expertise, the Committees also felt that collecting data on legal immigration status should not be part of the wait listing process.
The proposed definition of residency is also consistent with the Committees’ conclusion that those individuals who reside in the US, regardless of immigration status, may become deceased donors whereas those patients who do not reside in the US may not.

6. Citizenship/Residency: Will be Self-Reported
Candidate will declare the citizenship or residency categories during the wait listing process – same as today
Self-reporting this type of data has limitations – similar to other demographic information, which is similarly self-reported
Status may be self-evident from demographic information

7. OPTN/ UNOS data fields already modified
In June 2011, the Board Of Directors Approved Improvements to Data Collection As Follows:
US Citizen
Non-US Citizen/US Resident
Non-US Citizen/ Non-US Resident
Traveled to US for Reason Other than Transplant
Non-US Citizen/Non-US Resident
Traveled to US for Transplant

8. Eliminate 5% audit, simplify and focus review
Current 6.3 Audit
Committee can review audit programs where more than 5% of recipients are non citizens/non-residents.
Proposed 6.3 Review and Reporting of Data on Non-US Citizens/Non-US Residents.
Review all transplant center activities pertaining to citizen and resident status.
Ad Hoc International Relations Committee may request transplant centers to voluntarily provide additional information about listings or transplants of non-US residents/non-US citizens.
In identifying the problem the Committees seek to solve by this proposal, the Committees were influenced by the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, specifically the concepts of travel for transplantation and transplant tourism, which are defined 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.”
In March, 2009, the Board of Directors adopted the definitions in the Declaration of Istanbul for “organ trafficking,” “transplant commercialism,” “transplant tourism,” and “travel for transplantation.”
The Committees felt that the audit provision was widely misunderstood as a 5% cap on a transplant center’s ability to list and transplant non-US citizens. At the same time, the Committees concluded that the current audit provision was ineffectual as it lacks clarity on the purpose of the audit and it lacks any criteria regarding transplantation of non-US citizens against which to evaluate the activities of a transplant program. With the defined goal of collecting information to evaluate the circumstances of patients travelling to the US for transplantation, the Committees concluded that providing a percentage above which audit may be triggered was arbitrary and that transparency required that the ability to audit any time a patient who is a non US Citizen/Non-resident is listed and transplanted. The purpose of the audit is to discern the circumstances of non US citizens/Non-residents obtaining deceased donor transplants in the US (for example, did the patient travel to the US for transplantation that was available or unavailable in the patient’s country of residence?), and provide increased transparency regarding these practices.

9. New Transparency in Reporting Policy
6.3.1 Transparency in Reporting Listings and Transplants of Non-US Citizens/Non-US Residents
The Committee shall prepare and provide public access to an annual report of member transplant center activities related to the transplantation of non-US citizens/non-US residents.
Data is redacted to protect patient privacy
Transparency as primary to public trust

10. What the Proposal Does Not Do
Does not seek to prohibit non-US citizens/non-residents from being wait-listed and transplanted
Does not alter or impact allocation of organs based on residency or citizenship status
Does not penalize programs for transplanting non-residents

11. Status The proposal went to public comment in September
Comment period closed
Majority of comments in favor
Committee leadership with OPTN/UNOS and HRSA reviewed and further revised proposal in response
New categories of data collection for citizenship and resident status will go into in effect as of March 7, 2012.
Full Committees will vote on final proposal
Presentation to OPTN/UNOS Board this June

12. ACOT proposed motion
Recommend that the Secretary urge the OPTN/UNOS to pass the Policy 6 proposal as an important measure of public transparency.