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Proposed Revisions to Policy 6.0 Transplantation of Non-Resident Aliens

Proposed Revisions to Policy 6.0 Transplantation of Non-Resident Aliens. Sponsored by the Ad Hoc International Relations Committee & the Ethics Committee. Core Problems of Current Policy 6.0. Policy 6.0 is misunderstood in the transplant community

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Proposed Revisions to Policy 6.0 Transplantation of Non-Resident Aliens

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  1. Proposed Revisions toPolicy 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: • 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

  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.

  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.

  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.

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