OPTN Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens), Which Include Changes to the Non-Resident Alien Transplant Audit Trigger Policy and Related Definitions Sponsored by the Ad Hoc International Relations Committee & the Ethics Committee

OPTN Core Problems of Current Policy 6.0  Policy 6.0 is a confusing mix of regulations, much of it irrelevant and outdated  Much misunderstanding in transplant community  Minimal public “transparency” of practice with current data collection policy  Programs find themselves in the “immigration business”  Programs may be unnecessarily hesitant to transplant non-resident aliens for fear audit  “Under the radar” transplantation may endanger public trust  Data collection does not permit adequate evaluation

OPTN Current Policy Community Participation “Each member center which lists non- resident aliens on its Waiting List should establish a mechanism for community participation and review of its candidate acceptance criteria”

OPTN Goals of the new Proposal  Make Policy 6.0 align with current transplantation environment  Create transparency in the deceased donor wait-listing and transplant of non-citizen/non-residents  Understand the scope of “travel for transplantation” to the US, a phenomenon that may undermine the capacity to provide organs for its residents Residents of the US are potential deceased donors whereas non-residents are unlikely to be

OPTN Proposed Modifications (1/2)  Eliminate policies that are not enforceable  Retain ability of programs to import and export organs  Classify as residents (donors or candidates) any person who considers the US their primary place of residence  Allow the Ad Hoc International Relations Committee to audit and review all listings and transplants of non- citizen/non-resident patients Eliminate the “5% rule” Provides accuracy and transparency.

OPTN Proposed Modifications (2/2)  Delete the policy on ethical practices (6.4.4) Requirement to follow ethical practices applies to all OPTN requirements and is redundant in this section  Retain policy prohibiting contractual agreements regarding patient referrals  Retain policy on nondiscrimination in organ allocation (no “tiered allocation”)

OPTN Policies that Are Not Enforceable or Current  Policies (Transplant Centers), (Community Participation), and (Training Programs) are not enforceable Compliance-related revisions would likely result in language that mandates transplant center behavior not related to organ allocation  Content of Policy (Fees) aligns well with Policy (Nondiscrimination/Organ Allocation)

OPTN Policy Not Needed  Policy 6.5 (Violation) All policy violations are subject to review by the OPTN/UNOS Membership and Professional Standards Committee (MPSC)

OPTN Export of Deceased Donor Organs  Moves content of Policy 6.4 (Exportation and Importation of Organs-Developmental Status) to Policy (Prohibition for Organ Offers to Non- Members) Exportation is an exception to the prohibition of sharing organs with non-members; Policy 6.4 does not need to outline the recovery processes related to organ export These organs are recovered in the US and policies already address organ recovery requirements

OPTN Importation of Foreign Deceased Donor Organs  Retains the ability to import organs ad hoc and through a formal agreement – requirements are the same;  Deletes the requirement for a program to establish a formal agreement with a foreign agency if it imports more than six ad hoc organs from that foreign agency Six is an arbitrary number; Small number of deceased donor organ imports that occur in a given year do not warrant a policy 85 transplants with imported deceased donor organs during the 2003 through 2009 time period

OPTN Current Definitions  6.1.1Non-Resident Alien. A non-resident alien is an individual granted permission by the United States Government to enter the United States on a temporary basis as a non-immigrant alien for purposes which include tourism, business, education, medical care, or temporary employment.  6.1.2Domestic, American Candidate or Resident Alien. A domestic, American candidate or resident alien is an individual who is either an American citizen or is an immigrant alien granted permanent resident status by the United States Government or any individual, regardless of immigrant status, qualified for health care entitlement funds from state or federal government sources.

OPTN New Non-US Citizen Definitions  (Non-US Citizen/US Resident) – A person who is not a citizen of the United States, who is present in the United States, and for whom the United States is the primary place of residence.  (Non-US Citizen/Non-US Resident) – A person who is not a citizen of the United States and for whom the United States is not the primary place of residence.

OPTN 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

OPTN In June 2011, The Board Of Directors Approved Improvements to Data Collection Regarding the Citizenship And Residency Status Of Organ Donors And Recipients 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 Current OPTN forms require that the date of entry to the US be collected to calculate the length of time from entry to the US until the patient is added to the waiting list.

OPTN Focus of Review US ResidentNon-Resident US CitizenNo Non-US CitizenNoYes

OPTN New Audit and Reporting Policy  6.3 (Audit and Reporting of Non-US Citizens/Non-US Residents) As a condition of membership, all member transplant centers agree to allow the Ad Hoc International Relations Committee to review and, at its discretion, audit all member transplant center activities pertaining to transplantation of non-US residents/non-US citizens. At member transplant centers where non-US residents/non- US citizens are listed for transplant, the Ad Hoc International Relations Committee shall review the circumstance and justification for listing any non-US resident/non-US citizen traveling to the United States for transplant.

OPTN New Transparency in Reporting Policy  (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 privacy Audit does NOT entail referral to MPSC

OPTN What the Proposal Does Not Do  Does not seek to prohibit non-US citizens/non-residents from being wait-listed and transplanted  Makes no attempt to use citizenship or residency status in the allocation of organs  Does not seek to punish programs for transplanting non-residents but does seek to provide transparency

OPTN Additional Work for the Committees  Develop criteria for how the Ad Hoc International Relations Committee will audit a center’s listings and transplants of non-citizen/non-resident candidates

OPTN Recipient Data that may be Reviewed  A) Program is asked to confirm the accuracy of information submitted in routine forms related to this transplantation  B) New data 1) Country of citizenship 2) Country of residency 3) Dates the recipient spent in the United States during 12 months prior to wait-listing, and between wait-listing and transplantation 4) Date of departure from the United States after transplant 5) Duration of relationships between recipient and transplant surgeon, and between the recipient and medical transplant specialist, prior to wait-listing 6) Did the recipient travel to the U.S. for the primary purposes of transplantation? 7) How did the recipient learn about the transplant center? 8) Why did the recipient not seek transplantation in his primary country of residence?

OPTN Questions?