1. Improving the OPTN Policy Development Process Executive Committee Fall 2014

2. Key goal: Promote efficient management of the OPTN Objective: Improve responsiveness of OPTN policy to a changing environment OPTN Strategic Plan

3.  OPTN has ‘one size fits all’ process--no flexibility for solving different types of problems  Length of process has increased significantly in the last 5-7 years  can take 1.5 to 2 years to make even the simplest policy change Solution  Create two new policy development process tracks:  Emergency Actions  Expedited Actions The Problem

4. VCA Oversight Pediatric Lung Total Artificial Heart Emergency Actions Board is compelled to act before public comment and normal policy development process can be completed.

5. Limited to patient safety issues, statutory regulatory change that must be in place before public comment can be completed, or a new medical technology that affects organ allocation Board must specify a sunset date for the policy that is no more than 12 months after approval Policy must be distributed for public comment within 6 months of Board action Proposed New Process for Emergency Actions

6. Other routine updates LAS/CPRA algorithms Histo Bylaws Non-controversial Actions Non-controversial, routine changes are needed in a timely manner to be efficient

7. Proposed New Process for Non-Controversial Actions Sponsoring Committee distributes public comment proposal for new or existing policy and specifies policy sections that will be eligible for future expedited updates Board reviews and approves the policy including expedited process language At a later date, committee submits expedited proposal as stipulated by original policy. Expedited proposals require public comment of at least 30 days

8. No objections Policy changes take effect with notice to membership Possible Outcomes: Expedited Actions Objections from another committee, 5 members of public or 4 members of the Board Expedited process is not applicable. Proposal must follow normal development process #1 Some objections are received, but not enough to meet requirements in #2 above Sponsoring committee must present proposal to Executive Committee for review/approval #2 #3 _______________________________________________________________________

9.  Board review - June 2015  If approved, effective September 1, 2015 Expected Implementation

10.  Carl Berg, MD Committee Chair  Gena Boyle, MPA Policy Manager gena.boyle@unos.org Questions?

11. Extra Slides

12. Length of Process Over Time (from project start to BOD)

13. Length of Process Over Time (length of public comment)

14. 90 days for public comment (PC) period 240 days between PC distribution and BOD meeting 300-360 days between PC upload and BOD meeting 480 days between POC committee project review and BOD meeting Currently, on average, there are…

15. Board Actions By Date