1. Introduction Organ Transplantation Program Update Advisory Committee on Organ Transplantation November 17, 2015 Melissa Greenwald, MD Acting Director Division of Transplantation Healthcare Systems Bureau Health Resources and Services Administration Department of Health and Human Services

2. 2 OPTN Milestone As of May 19, 2015 Over 500,000 transplants have been coordinated by the Organ Procurement and Transplantation Network (OPTN) from deceased donors in the United States since its beginning in October 1987 More than 250,000 recipients of these transplants are estimated to be surviving, and more than 225,000 are estimated to have a functioning transplanted organ

3. 3 OPTN Updates Kidney Allocation System (KAS) New KAS (12/4/14) appears to be meeting expectations on a number of key outcomes, including Better use of available kidneys Improved transplant opportunities for difficult to match candidates Increased proportion of African-American transplant recipients (to ~38%) Some key policy goals will require long-term data Reduced rate of repeat transplants Extended time recipients have a functioning kidney Transplant waiting time for candidates who began dialysis before being listed for a kidney transplant

4. 4 OPTN Updates Liver Policy OPTN Educational Forum June 22, 2015 Sought additional public input on increasing equity in access to liver transplantation Committee continuing to consider additional results in modeling already performed Committee continuing to further analyze additional considerations raised at the forum (e.g., different geographic model, cost issues) New analyses will be available over the next few months to inform next steps in policy development No policy proposal immediately forthcoming

5. 5 OPTN Updates Vascularized Composite Allografts (VCA) Standards for VCA transplants updated in June 2015 (from criteria initially adopted in June 2014) membership requirements including training and experience criteria for surgeons and physicians allocation from deceased donors authorization for allocation from deceased donors standardized data collection Guidance document re: living donation of VCA Educational video (August 2015)

6. 6 OPTN Updates HOPE Act Implementation May 8, 2015 OPTN published amendment to Final Rule permitting transplantation of organs from donors who are HIV-positive to recipients who are HIV-positive, in the context of clinical research June 2, 2015 OPTN Board of Directors approved policies to allow recovery and transplantation of organs from HIV-positive donors Policies include specific patient safety measures to assure that these organs are only used for HIV-positive candidates Fall 2015 HOPE Act changes will be in effect OPOs will be able to run HIV positive kidney and liver matches Match runs will only include HIV positive candidates listed at centers with HOPE Act IRB approval

7. 7 Operational Updates HRSA-sponsored OPTN Studies OPO performance metric data collection Goal: identify new objective measures on OPO donor referral Action: develop and test a data collection tool in a sample of OPOs Outcome: identify and collect standardized data on OPO donor referral Transplant center performance Goal: assess value, practicality, and broader applicability of a new model to improve program performance Action: develop and test the Collaborative Information Innovation Network (COIIN) framework focus on hard-to-place organs Outcome: encourage knowledge transfer of best practices allow for real time data to influence center behavior

8. 8 OPTN Updates TransNet  Project is transitioning to full OPTN development/implementation  HHS Entrepreneur completed tenure  OPTN expected to consider policy to mandate OPO deployment of TransNet labeling and tracking application over the next year  Application is now developed for both android tablets and ipads  Transplant center application in beta testing and deployment will likely take place over a longer period of time

9. 9 SRTR Update Contract Recompetition/Award v Scientific Registry of Transplant Recipients (SRTR) contract Awarded to Chronic Disease Research Group (CDRG) of the Minneapolis Medical Research Foundation (MMRF) through September 2020 SRTR will continue to provide statistical and analytic support to the OPTN to assist in formulation and evaluation of organ allocation policy in the United States (U.S.) SRTR also reports national transplant data and conducts research on solid-organ transplantation in the U.S. SRTR provides analytical support to ACOT

10. 10 SRTR Update Living Donor Registry Feasibility Study New task SRTR contract: conduct feasibility study for a national living donor registry to monitor long-term outcomes of living donors Feasibility study plan to include: identify donor and control cohorts develop study consent form determine follow-up frequency develop survey instruments and data collection forms to monitor the intermediate- to long-term development of comorbidity and serious events assess psychosocial and socioeconomic consequences of donation identify data collection methods detailed estimates of the first year start-up cost and subsequent annual operating cost

11. 11 Questions?

12. 12 Contact Information Melissa Greenwald mgreenwald@hrsa.gov Chris McLaughlin cmclaughlin@hrsa.gov