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, AHIRCAlexandra K. Glazier, JD, MPH – Chair, Ethics Committee

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Some requirements are outdated

Problems with Current Policy

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

Summary of Proposed Policy Solutions

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

Proposed Policy Changes…

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

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

Citizenship Data:March 8 to April 7, 2012

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%) 0

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

Public Comment Response to Original Proposal

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

Primary Public Comment Recommendations

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.6.1.2 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.

Policy Changes Made After Public Comment: Residency Definitions

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.

Policy Changes Made After Public Comment: Review

To permit further evaluation and understanding of data collected for possible future policy development

Purpose for Requesting Additional Information from Transplant Programs

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.

Policy Changes Made After Public Comment: Data Reports

The revised proposal relocates language about valuable consideration

Edited nondiscrimination policy language so that it applied to all candidates, not just non-residents

Policy Changes Made After Public Comment: Valuable Consideration and Nondiscrimination

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

Policy Changes Made After Public Comment: Organ Export

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

Summary

**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

Resolution

Questions?