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Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens)

This proposal aims to address the lack of transparency and outdated policies in the transplantation of non-resident aliens. It proposes changes such as providing public access to information, eliminating the audit trigger policy, and reorganizing import and export policies.

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Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens)

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  1. Proposed Revisions to and Reorganization of Policy 6.0 (Transplantation of Non-Resident Aliens) Sponsors: Ad Hoc International Relations Committee and Ethics Committee Gabriel M. Danovitch, MD – Chair, AHIRC Alexandra K. Glazier, JD, MPH – Chair, Ethics Committee

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and transplants • Much misunderstanding in transplant community about the audit trigger policy • Some requirements are outdated

  3. Summary of Proposed Policy Solutions • Provides public access to information re 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

  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 punish 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 • Non-US Citizen/Non-US Resident*, 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

  7. Public Comment Response to Original Proposal

  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

  9. Policy Changes Made After Public Comment: Residency Definitions • Refined residency definitions 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.6.1.2Non-US Citizen/Non-US Resident – A non-citizen of the United States for whom the United States is not the primary place of residence.

  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.

  11. Purpose for Requesting Additional Information from Transplant Programs To permit further evaluation and understanding of data collected for possible future policy development

  12. Policy Changes Made After Public Comment: Data Reports • 6.3.1 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.

  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

  14. Policy Changes Made After Public Comment: Organ Export • Further edits made to the organ export policy3.2.1.4 Prohibition for Organ Offers to Non-Members. 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

  15. Summary • Goals are to: • Fortify public trust in the US organ recovery and transplantation system • Collecting and releasing data that the US public has a right to know • Remove arbitrary nature of current review threshold • Clarify aspects of policy language

  16. Resolution **RESOLVED, that Policies 1.0 (Member Rights and Obligations), 3.2.1.4 (Prohibition for Organ Offers to Non-Members), and 6 (Transplantation of Non-Resident Aliens) shall be modified as set forth in Resolution 24, effective September 1, 2012 and notice to OPTN membership

  17. Questions?

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