Organ Transplantation Program Update August 28, 2012

1. Organ Transplantation Program UpdateAugust 28, 2012 Christopher J. McLaughlin Chief, Organ Transplantation Branch Division of Transplantation Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau

2. Policy Updates OPTN Liver Allocation Policy • OPTN approved “National Share 15” policy • Adult deceased donor livers to be offered to all candidates with MELD/PELD scores of 15 or higher locally, regionally, and nationally before being offered to candidates with lower MELD/PELD scores. • OPTN also approved “Regional Share 35” policy • Adult deceased donor livers would be offered to combined local and regional candidates with MELD/PELD scores of 35 or higher (“tiered regional sharing”).

3. Policy Updates SRTR Liver Region Redesign Project • HRSA provided $500,000 additional funding to SRTR to conduct analyses supporting OPTN developing evidence-based approaches for geographic distribution of livers. • Approach is to design allocation policies using a principles-based framework and mathematical optimization. • Liver community finds consensus on a few simple principles – a primary metric for evaluating any proposed allocation system--design the liver distribution units to meet the specified goal (subject to a priori specified constraints) • Mathematical optimization - aggregate geographical areas into larger units to maximize a numerical objective function (goal of the redesign) while satisfying stated constraints (allowable number of units would be one of the constraint). • Much of the modeling complete—SRTR will now ask OPTN Board and Liver Committee to establish liver policy goals and requirements that will guide the process.

4. Policy Updates OPTN Living Donor Policy Status • OPTN released three Living Kidney Donor policies for public comment • Medical and Psychosocial Evaluation • Informed Consent • Follow-up • Policies were not reviewed by OPTN Board in June due to procedural issues • Expected to return to OPTN Board for review in November • Process to develop analogous Living Liver Donor policies has begun • Joint Society recommendation development • OPTN Living Donor Committee policy development

5. Policy Updates OPTN Kidney Allocation Policy • OPTN Kidney Committee planning to release public comment proposal on September 21, 2012 • Proposal intended to enhance post-transplant survival benefit, increase utilization of donated kidneys and increase transplant access for biologically disadvantaged candidates. • Proposal to incorporate new features: • expanded definition of waiting time based in part on the date of initiation of renal dialysis, • a sliding scale for assigning points to sensitized patients, • expanded access for blood type B candidates who can accept kidneys from subtypes of blood type A donors, • broader sharing for extremely highly sensitized candidates, • longevity matching of some kidneys, and • regional sharing for kidneys with the highest risk of discard.

6. Policy Updates Status of VCA Rule/PHS High Risk Guidelines • Vascularized Composite Allografts (VCA) NPRM • Published December 17, 2011 • Closed February 14, 2012 • 28 comments received – favorable • Draft Final Rule undergoing internal HHS review • US Public Health Service/CDC Organ Donor Screening Guidelines • Internal/external review work group met in June

7. Operational Updates OPTN Contract Extension/Recompetition • OPTN contract in place since 2005 has been extended for 6 months until March 30, 2013 • HRSA published RFI Jan. 6th, closed Feb. 17th seeking input on: • Use of subcontracting • OPTN National KPD program • Ways to enhance public participation • OPTN role in educating members • Expansion of compliance on monitoring function particularly for living donors • Expanding OPTN’s research capacity • Enhancing IT capacity and responsiveness • Request for Proposals will be posted as soon as possible

8. Operational Updates OPTN Deceased Donor Potential Study • HRSA provided $1.6 million direct funding to UNOS (Center for Transplant System Excellence) to conduct a study evaluating donor potential in the U.S. • Findings to serve as basis for evidence-based goal setting • Rigorous methods • Demographic and epidemiological approaches • Systems dynamics modeling • Measure variables affecting donor potential • Address full range of donor potential

9. Operational Updates SRTR PSR Conference Follow-up • OPTN and SRTR consensus conference on Transplant Program Quality and Surveillance took place February 13-15, 2012. • Short- and Long-Term Action Items have been developed and placed on the SRTR web site and will be updated as work progresses. • SRTR produced a PSR Manual of Operations detailing the SRTR process for risk model development and oversight. • Moving towards a 3-year cycle of model development with formal input and involvement from the OPTN committees. • Initial kidney model building steps are underway.

10. Operational Updates SRTR PSR and OPO Report Improvements • July 2012 transplant program PSR has a new format using color and enhanced visual display to depict the same content in the traditional program-specific report. • OPO-specific PSRs now contain measures of expected donor yield using the models approved by the OPTN/UNOS Board in 2011. • The SRTR released a Donor Yield Calculator tool available for download on the secure websites that OPOs can use to track observed and expected donor yield using the new models.

11. Operational Updates HRSA/CMS Alignment Activities • HRSA, CMS, and the OPTN contractor have been working to identify areas of compliance overlap as a first step in the process of better aligning CMS and OPTN requirements. • First product will be a crosswalk of requirements from the CMS transplant center Conditions of Participation and the OPTN Bylaws and Policies. • Possible release of the crosswalk and educational webinar in November • Crosswalk will enhance efforts underway to modify OPTN and CMS requirements and survey processes to address areas that are similar but not identical. • It is hoped that these changes will provide clarity and make it easier for transplant centers to comply with both CMS and OPTN requirements.

12. Operational Updates Community of Practice • Organ Donation and Transplantation Community of Practice • Sustain and improve upon the gains made from the Collaboratives • 7th National Learning Congress: October 4-5, 2012 • Grapevine, Texas • Theme: Intentional Integration of Quality Processes • Tracks: • Donor Designation • Advocacy • Donor Management • Pediatrics • Transplantation • Leadership

13. Operational Updates Public & Professional Education • 50+ Campaign launched • Print PSAs appearing in major National magazines • Workplace Hospital Campaign • Donate Life Month – November 2012 • Social Media • Working with Dr. Howard Koh, Assistant Secretary for Health, to help promote donation

14. Operational Updates National Living Donor Assistance Center • Cooperative Agreement awarded to University of Michigan in 2006. Michigan subcontracted with the American Society of Transplant Surgeons to operate the system. System became operational in October 2007 • Since becoming operational in October 2007, the NLDAC received 2,271 applications of which 2,012 were approved for funding and 1,123 living donation have been completed. The average reimbursement to donors and companions is $2,539. The NLDAC, since its inception, has paid out $3.57 million to donors

15. Operational Updates HHS Innovation Fellowship Program • DoT chosen to participate in a new HHS program designed to increase innovative thinking and problem solving in the Department. • Innovation Fellow will join us for one year to help us work with the OPTN to develop a new system for electronic identification and tracking of organs.

16. Questions?

17. Contact Information Chris McLaughlin Chief, Organ Transplantation Branch Division of Transplantation 301-443-0036 cmclaughlin@hrsa.gov