Membership and Professional Standards Committee Fall 2012

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. The Problem • 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

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

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

5. How the Proposal will Achieve its Goal WL Inactivation • 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

6. How the Proposal will Achieve its Goal WL Inactivation II • 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

7. How the Proposal will Achieve its Goal WL Inactivation III • When to send notifications:

8. How the Proposal will Achieve its Goal WL Inactivation IV • Example: Program reaching cumulative waiting list inactivation of 28 days or more in one 365 day Period

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

10. How the Proposal will Achieve its GoalProgram Component Cessation (cont.) • 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

11. Impact • 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

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

13. What Members Will Need to Do • 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

14. Specific Requests for Comment • Questions refer to Appendix K, section A (program component cessation bylaw), page 94 in the public comment document • Is the term ‘affected patients’ clear enough? Proposed language includes these groups: • Potential Candidates • Waitlisted Candidates • Potential Living Donors

16. Questions? 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