1. Proposed Revisions to and Reorganization of Policy 6
Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens)
Sponsors: Ad Hoc International Relations Committee and Ethics Committee
The Committees intend for the proposed policies in Policy 6 to apply only to deceased donor organs (not living).
Policy 6.0 is really two sets of policies
The effort to revise policy did not do a complete ‘cleanup.’ The focus of the revisions was on select sections of Policy 6. Which were relevant to both EC and AHIRC
Other changes to requirements in Policy 6 need further substantive review by the AHIRC.
Gabriel M. Danovitch, MD – Chair, AHIRC
Alexandra K. Glazier, JD, MPH – Chair, Ethics Committee

2. Problems with Current Policy
Much misunderstanding in transplant community about the audit trigger policy
Lack of transparency regarding non-citizen and non-resident listings and transplants
Some requirements are outdated

3. Summary of Proposed Policy Solutions
Provides public access to information on non-citizen and non-resident listings and transplants
Provides definitions for recently implemented citizenship data collection points
Eliminates audit trigger policy (“5% rule”)
Implements review of all non-citizen and non-resident listings and transplants
Deletes policies that are not enforceable
Clarifies and reorganizes import and export policy
Technical, non-substantive clean-up edits to import and export policy
How OPTN system is working

4. Proposed Policy Changes…
Do not prohibit non-US citizens/non-US residents from being wait-listed and transplanted
Do not use citizenship or residency status in the allocation of organs (“tiered allocation”)
Do not penalize programs for transplanting non- residents– there is no audit provision

5. Data Collection Approved June, 2011 Implemented on March 7, 2012
US Citizen
Non-US Citizen/US Resident
Non-US Citizen/Non-US Resident*,
Traveled to US for Reason Other than Transplant
Traveled to US for Transplant
*Current OPTN forms require that the year of entry to the US be collected; can calculate the length of time from entry to the US until the patient is added to the waiting list

6. Citizenship Data: March 8 to April 7, 2012
46 non-US citizens/non-US residents registered on the Waiting List
20 candidates came to the United States for the purpose of transplantation
This was under 1% of all registrations added
These data indicate what the AHIRC and the Ethics Committee anticipated
Transplant programs are checking the box about traveled to US for transplant
(Most were liver candidates
Those that did not were kidney candidates)

7. Public Comment Response to Original Proposal
Type of Response
Response Total
In Favor
In Favor as Amended
Opposed
No Vote/ No Comment / Did Not Consider
Individual 33
18 (62.1%)*
0 (0%)
11 (37.9%) 4
Regional 11
7 (63.6%)
3 (27.3%)
1 (9.1%)
Committee 18
4 (57.1%)
1 (14.3%)
2 (28.6%)
11**
*The percentages in each row reflect the total number of individuals, regions, and committees, respectively, that voted (in favor, in favor as amended, opposed) on the proposed policy.
**Some of the Committees represented here provided comments, but did not vote on the proposal.
Policy Oversight Committee approved, unanimously, the policy presented to the Board
Twenty-nine individuals voted on revisions to Policy 6. All 11 regions voted on revisions to Policy 6. Seven Committees voted on revisions to Policy 6.
At committee, regional and individual level
Twice to POC
Final policy differs in several respects from that submitted for public comment

8. Primary Public Comment Recommendations
Retain language about valuable consideration
Refine the residency definitions
Define “exhausting the match run”
Edit the proposed review and reporting policy
Concern about the use of the terms “justification” and “audit”
Concern about the burden the review policy would place on transplant hospitals to provide data for the AHIRC
Retain language about valuable consideration
The revisions to Policy 6 deleted language about valuable consideration. During public comment, concerns were raised that the removal of the policy altogether, especially language about valuable consideration, may not be prudent.
Modify the organ export policy (Define “exhausting the match run”)
Modify the residency definitions (How is residency best reported?; Current residency definitions may place transplant programs in a position of sorting through immigration information.)
Modify the proposed review policy
The comments submitted were mostly supportive of the suggested changes.
Proposed review policy -- first step in making it a policy violation to transplant non-residents.
Proposed policy lacked an explanation about the review process, thereby leaving the transplant community wary of the proposed review.
Review itself may be burdensome to the transplant centers. If a review were to occur, perhaps the submission of data should be voluntary.
Review policy may give too much oversight to the Ad Hoc International Relations Committee.
Retain the greater-than-5% audit trigger policy – a concrete threshold by which transplant programs can decide when to stop listing or transplanting non-residents during a given calendar year.
Greater-than-5% audit trigger policy may better achieve the goal of reducing transplant tourism in the US than the proposed review policy, which has no limit to the number of non-residents that may be transplanted.
Modify proposed reporting policy (Report all citizenship data; Keep individually identifiable patient data remain private; How will the data be treated?)

9. Policy Changes Made After Public Comment: Residency Definitions
Refined residency definitions (“US citizen” need not be defined as self-evident) to be consistent with new data collection points
6.1.1 Non-US Citizen/US Resident – A non- citizen of the United States for whom the United States is the primary place of residence Non-US Citizen/Non-US Resident – A non-citizen of the United States for whom the United States is not the primary place of residence.
NOTE – there is no need to define “citizen” as self-evident. Residency however is subject to more interpretation. Purposeful selected a common / plain language meaning. Per public comment, revised these definitions to be parallel.

10. Policy Changes Made After Public Comment: Review
6.3 Review and Reporting of Non-US Citizen/Non-US Resident Listings and Transplants. The Ad Hoc International Relations Committee will review all citizenship data submitted to the OPTN Contractor. The Ad Hoc International Relations Committee may request that Member transplant centers voluntarily provide additional information about listings or transplants of non-US citizens/non-US residents.
Remove words such as audit and justification
Voluntary provision of responses by transplant programs
“Voluntary” to avoid intrusiveness and onerous data reporting requirements

11. Purpose for Requesting Additional Information from Transplant Programs
To permit further evaluation and understanding of data collected for possible future policy development
Sample questions:
In which country or countries is the candidate or recipient a citizen?
Did the candidate or recipient seek organ transplant service for her or his organ failure in her or his home country or countries of citizenship?
What were the dates when the candidate or recipient stayed in the US between listing and receiving an organ transplant?
On what date did the candidate or recipient leave the US after receiving the organ transplant?
Why was the candidate or recipient in the US – business, tourism, obtaining higher education, or another reason? (This question only applies to those who did not “travel for transplant.”)
Why did the candidate or recipient travel to the US to receive an organ transplant?
How will, or did, the candidate or recipient finance the transplant?
How did the candidate or recipient receive funds for the listing or transplant – personal, government agency, or a non-governmental agency?
Random sample of listings and transplants (Considering sampling 20% of all programs that list or transplant non-residents)

12. Policy Changes Made After Public Comment: Data Reports
Transparency in Reporting Listings and Transplants of Non-US Citizens/Non-US Residents. The Ad Hoc International Relations Committee shall prepare and provide public access to an annual report of Member transplant center activities related to the listings and transplantation of non-US citizens/non-US residents.
Data to be reported through the OPTN or UNOS web sites
Anticipate preparing an aggregate document as a pdf for posting to the web site
If Policy 6.3 is approved, the AHIRC will operationalize the policy once it is approved
Questions asked of members will be consistent and non-judgmental questions.
Accuracy of self reported data suspect, and the OPTN has a responsibility to publish accurate data. But, Would publishing these self-reported data be any different than other data self-reported to the OPTN?

13. Policy Changes Made After Public Comment: Valuable Consideration and Nondiscrimination
The revised proposal relocates language about valuable consideration
Edited nondiscrimination policy language so that it applied to all candidates, not just non- residents
Original valuable consideration language:
6.4.4 Ethical Practices. No member will engage in practices which might discredit the transplant community. Organs accepted for importation must be from deceased donors and must have been voluntarily donated. Organs imported from living donors or organs for which compensation has been made or promised are not acceptable for exchange or acceptance by members.
Revised valuable consideration language:
1.1 Obligation to the National Organ Transplantation Act
An OPTN member may not knowingly permit donation, recovery, or transplantation of deceased or living donor organs for valuable consideration.
Original non-discrimination language:
6.2.1 Nondiscrimination/Organ Allocation. Selection, from the Waiting List, of non-resident alien candidates for transplantation shall be based on the same allocation policies (Section 3.0) mandated by the Board of Directors for selection of domestic candidates. Such selection shall not be influenced by favoritism or discrimination based on political influence, national origin, race, sex, religion or financial status
Revised non-discrimination language:
6.2.1 Nondiscrimination in Organ Allocation. Deceased donor organ allocation to candidates for transplantation shall not differ on the basis of a candidate’s citizenship or residency status in the US. Allocation shall not be influenced by favoritism or discrimination based on political influence, national origin, race, sex, religion, or financial status.

14. Friendly Amendment: Export (1/2)
Line 51, after Status).
Strike
Members can only share organs with Members or countries. Members may only export deceased donor organs outside of the United States after a well documented and verifiable effort, coordinated through the Organ Center, has been made to offer these organs to potential recipients on match runs. Prior to exporting deceased donor organs, Members must submit the organ export verification form to the OPTN Contractor.
Restores orginal language and intent

15. Friendly Amendment: Export (2/2)
Line 51, after Status).
Insert
Members shall not provide organs to non-Member Transplant Centers except to Transplant Centers in foreign countries. Exportation of organs from the United States or its territories is prohibited unless a well documented and verifiable effort, coordinated through the Organ Center, has failed to find a suitable recipient for that organ on the Waiting List.

16. Summary
Goals are to:
Fortify public trust in the US organ recovery and transplantation system
Collecting and releasing data to the US public
Remove arbitrary nature of current review threshold
Clarify aspects of policy language
Public is the source of deceased donors

17. Resolution
**RESOLVED, that Policies 1.0 (Member Rights and Obligations), (Prohibition for Organ Offers to Non-Members), and 6 (Transplantation of Non-Resident Aliens) shall be modified as set forth in Resolution 24, as amended, effective September 1, 2012 and notice to OPTN membership

18. Questions?