1. Proposal to Change the OPTN/UNOS Bylaws to Better Define Notification Requirements for Periods of Functional Inactivity Membership and Professional Standards Committee Fall 2012

2.  Bylaws do not clearly outline Member actions for functional inactivity, including:  Periods of waiting list inactivation  Cessation of a transplant program component (e.g. Living Donor/adult-peds)  Since the Bylaws do not specifically address notification content or timing, programs have been inconsistent in how they notify patients The Problem

3.  Detailed, timely patient information regarding periods when organ offers will not be made on their behalf  More guidance for MPSC to monitor functional inactivity Goal of the Proposal

4.  Clearly define Member responsibilities:  Clarify patient notification content and timing requirements for periods of waiting list inactivation in UNet sm  Specify Member actions for notifying patients when a program voluntarily ceases performing a specific type of transplant Goal of the Proposal (cont.)

5.  Current bylaw requires programs to provide written notice to potential candidates and candidates of waiting list inactivity  Proposed modifications: waiting list inactivity notifications must contain the following:  Reason  Expected length  Explanation organs cannot be accepted during this time How the Proposal will Achieve its Goal WL Inactivation

6.  Notification content requirements (cont):  Options available to the candidates, including multiple listing/transfer  Mechanism for notifying candidates when WL is reactivated or if the expected length of inactivation is extended  Copy of Patient Information Letter  Cumulative notice must include dates for each instance of WL inactivation How the Proposal will Achieve its Goal WL Inactivation II

7.  When to send notifications : How the Proposal will Achieve its Goal WL Inactivation III Periods at least 30 days in advance Periods less than 30 days in advance Cumulative Periods Notification Must Be Sent 30 days prior to WL inactivation No later than 7 days following WL inactivation No later than 7 days after last date of period that exceeded threshold

8.  Example: Program reaching cumulative waiting list inactivation of 28 days or more in one 365 day Period How the Proposal will Achieve its Goal WL Inactivation IV Instances of Inactivation at Program A Start Date Consecutive # of Days Inactive # of Days WL inactive for Review Period Running total: Cumulative # of days 11/10/11333 23/15/117710 36/27/117717 48/20/114421 511/22/1113 34 612/22/117741 Total # of Cumulative Days WL Inactivated in Period 141

9.  Members must:  Notify all patients affected by the cessation at least 30 days prior to, but no later than 7 days after cessation How the Proposal will Achieve its Goal Program Component Cessation

10.  Patient notifications must include:  Reason for cessation  Explanation that organs cannot be accepted on the candidate’s behalf during period of cessation  Patient options  Phone number for the transplant program’s administrative office How the Proposal will Achieve its Goal Program Component Cessation (cont.)

11.  12 programs met WL inactivation thresholds in 2011  4 programs ceased a component in 2011  Proposed requirements could result in additional financial burden to send notifications, increase in patient calls/questions, submission of responses to MPSC inquiries Impact

12.  Anticipated Date of Board Consideration: June 2013  Anticipated Effective Date: September 1, 2013 Expected Implementation

13.  WL inactivation:  Include required elements in patient notifications  Send within specified timeframe  Cessation:  Include all required elements  Send within specified timeframes  MPSC will continue to monitor periods of WL inactivation and will request confirmation that you notified patients What Members Will Need to Do

14.  Is the term ‘affected patients’ clear enough?  Should adult candidates be notified of the cessation of a pediatric component and vice-versa?  Should transplant recipients be notified of the cessation of living donor, deceased donor, or age-specific components?  Should there be different patient notification timelines for living versus deceased donor program components?  Proposed Bylaw language on pgs. 10-11 of public comment proposal document Specific Requests for Comment

15. MPSC Chair: Kenneth Andreoni, MD MPSC Vice Chair: Alan Reed, MD Staff Liaisons Heather Neil 804-782-4747 heather.neil@unos.org Sally Aungier 804-782-4812 sally.aungier@unos.org Questions?