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Brian Shepard Chief Executive Officer Region 7 September 17, 2015

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1 Brian Shepard Chief Executive Officer Region 7 September 17, 2015
UNOS Update Brian Shepard Chief Executive Officer Region 7 September 17, 2015

2 OPTN and UNOS Strategic Planning
First, I want to follow up on the strategic planning conversation we had during the fall 2014 regional meetings.

3 2012 v Goals In June, the board adopted a new strategic plan. The primary goals of the plan are similar to goals that were in the 2012 plan. There are a couple of differences. The most significant is that while the last plan separated living donation as its own category, primarily focused on safety, the new plan integrates living donation into all facets of donation and transplantation. The other change in the goals was to clarify that the intent of the access goal was equity.

4 Feedback from Regional Surveys
The most significant change, though, was to prioritize our future efforts toward these organizational goals. We started the prioritization process in regional meetings like this one, asking you what the most important priority of UNOS should be. We heard overwhelmingly that the most important focus of the network right now should be working to increase the number of transplants.

5 Re-Balancing Resource Allocation
allocation of effort: Increase transplants 40% Provide equity 30% Improve outcomes 15% Promote safety 10% Promote efficiency 5% So that’s what we did. In addition to naming strategic goals and specific objectives to support each goal, the Board also approved an allocation of effort towards the goals, clearly making the number of transplants the goal that receives the most time and resources right now. This allocation is something we’ll continue to review and adjust on an annual basis, and we’ll reexamine the plan in its entirety in three years.

6 Committee Project Portfolio
The next step was to start to adjust our workload to reflect the priorities of the strategic plan. The executive committee and the policy oversight committee (which includes representatives of all the committees) worked to adjust the current list of committee projects to match the new plan. This required making some hard decisions to stop work on projects that were focused on other goals in order to create the bandwidth to add new projects that might affect the number of transplants. This slide shows a comparison of the current projects by resource allocation and the gap between where we are and where we would be according to the benchmarks in the draft. It was a difficult process, but it is important to align our resources with the outcomes we hope to achieve.

7 Metrics and quality improvement
UNOS is in the middle of several efforts to improve the way that we evaluate member performance. One focuses on removing perceived disincentives for accepting less than ideal organs, another hopes to improve the baseline against which OPOs are measured, and a third project hopes to create an alternative program evaluation based on quality and sound processes.

8 MPSC Outcomes workgroup
The first of these efforts to get underway was the MPSC outcomes workgroup. Representatives from several societies worked together to consolidate some conversations in the community about the perception that using some less than ideal organs was a good way to get yourself flagged. While that belief doesn’t bear up to statistical analysis, the perception is driving some programs’ acceptance behavior and potentially having a negative impact on the number of transplants. The AAAU group attempted to pull together multiple threads of this conversation, and presented a recommendation to a special workgroup of the MPSC about how to exempt some high KPDI kidneys from review. The MPSC has taken that recommendation and done additional analysis, especially looking at how to make sure any change doesn’t just move the flags to a different set of centers. One approach may be a dual system where programs would have to be outside the expected performance for all kidneys and for some definition of “standard” kidneys in order to be flagged for further review. MPSC Outcomes workgroup

9 OPO evaluations The second effort is based on furthering a project started by AOPO and the SRTR. AOPO has recommended changes to CMS’ OPO metrics that would make the CMS metric much closer to the existing OPO metric. For many years, CMS has used the eligible death data as the denominator in the metric they use to assess OPO referral performance. It has been acknowledged that the current eligible death definition may not be applied consistently across the country and therefore may not be the best data to use for this purpose. The community has struggled with what to use as the denominator for this metric that is one piece of the OPO performance puzzle. The AOPO membership has proposed that in hospital ventilated deaths should be the denominator for a new OPO referral performance metric. These data are not currently collected by the OPTN. Over the next year, UNOS will conduct a validation study. The purpose of the study is to assess the feasibility of collecting these data in a uniform matter to include the availability of data as well as the burden of collecting these data on the OPTN and the OPOs.

10 Member Quality Pilot The third and most sweeping of the performance assessment projects is the development of a pilot project to test an alternative assessment system based on quality and process improvement rather than statistical outcomes. HRSA has proposed funding a pilot project over the next two years to test the idea that a focus on quality and process can promote quality improvement and give a more consistent view of program performance than the statistical analysis of a small number of transplants. UNOS will spend the next year designing the alternative assessment including the types of things to measure, what (if any) new data would be necessary, what the criteria for entering the pilot project will be, and exactly how the results of reviews can be used to drive program improvement. Beginning in the fall of 2016, we’ll begin the actual pilot project to test the ideas. Together, these three ideas are concrete steps in determining how best to promote member quality, drive higher performance, and avoid disincentives to transplantation.

11 Real Life Lessons Another quality improvement effort worth a mention is the recent patient safety webinar on effective communication. This webinar wasn’t created to explain a particular new policy or Unet change – it is a discussion of potential patient safety scenarios based on real-life experiences. The cases are composites of real cases. The UNOS instructional staff are working with the Ops and Safety committee to create a series of these real life lessons. The first video has been seen more than 500 times so far. The next one will be released in October.

12 OPTN/UNOS Finance Update
Next, I want to give you a quick update on OPTN/UNOS finances.

13 OPTN Revenue: Registrations
Registrations have been rising for the last several years, and the UNOS projections are for another increase in the coming year. That said, this year is running slightly below projections. While the current number is close enough for the UNOS staff to manage the gap, we are closely watching the trend and any future affect it might have on the budget.

14 OPTN Funding The OPTN contract is funded with OPTN registration fees and federal appropriations 2016 OPTN budget is $49,497,000. $44,876,000 in OPTN fees for operations $ 3,500,000 in federal appropriations for operations $ 1,121,000 to OPTN fees for reserves 2015 OPTN budget was $48,313,000. $43,623,000 in OPTN fees for operations $ 3,000,000 in federal appropriations for operations $ 1,690,000 in OPTN fees for reserves The budget that the Board approved in June is about 2.2% higher than the current fiscal year budget. As UNOS negotiated in the last contract, federal funding will be $500,000 greater than in 2015.

15 Fees Combined OPTN and UNOS fees remain at $957.
OPTN fee increased $19, while UNOS fee declined $19. $20 of each registration fee is dedicated to OPTN reserves. $20 of each registration fee is dedicated to UNOS reserves. The relatively stable expense projection allowed the Board to approve the 2016 fee at the same level as the 2015 fee. The OPTN and UNOS shares of that fee shifted a little to reflect the way IT hardware is purchased by UNOS and later depreciated against the contract, but the overall fee remains the same. This is the third year in a row with a combined fee of $957.

16 Projected Costs and Fees
FY 2015 FY 2016 FY 2017 FY 2018 Expenditures $46,622,786 $48,376,211 $49,370,410 $50,826,810 Funding HRSA Federal Appropriations $3,000,000 $3,500,000 $4,000,000 $4,500,000 Reg Funding Carryover from FY 14 (IT fees) 2,100,000 500,000 Projected Registrations 54,500 56,066 56,727 57,197 Calculated OPTN Base Fee $762 $792 $800 $810 OPTN Base Fee OPTN Reserve Fee $31 $20 Total OPTN Fee $793 $812 $820 $830 Looking ahead, three straight years of the same fee is likely as long as we can hold it there. Using some of the numbers that we know and some basic assumptions about the future, there are likely to be fee increases of $8-10 in the next couple of years. This is not a firm budget proposal for 2017 or It’s just a look ahead at the direction things are going right now. We’ll continue to keep a close eye on expenses to ensure that members are getting value for their registration fees.

17 UNOS IT update

18 2015 IT Releases Membership Screening for Kidney and Pancreas
Revise the Lung Allocation Score (LAS) Pediatric Lung Other Specify Diagnosis Require HLA C and DQB (First Increment) Tiedi OMB Form Changes Living Liver Donor Follow-up Potential Derived Disease Transmission Reporting Pediatric Liver – Remove ICU Requirements Pediatric Liver – Revise Hepatoblastoma Requirements Update HLA Equivalency Tables Update HLA Equivalency Tables Transnet Android National Deployment Transnet Web OPO Functionality Match Run Changes HOPE ACT membership application (internal) Comprehensive Histo Rewrite Deceased Donor Updates Transnet iPad (Beta release) Infectious Disease Transnet TxC Match/Receipt IT continues to work at a significantly faster pace than in prior years. This is a quick look at the number of projects that have been delivered since January – by far the largest number in recent years.

19 2015 Board Project Plan Even though the backlog is significantly smaller, the executive committee will remain involved in prioritizing the remaining projects until we’re caught up and are able to start all new board approved projects before the next board meeting following their approval, and finish them all within 12 months. JUST FYI FOR SPEAKER: This plan anticipates the implementation of all BOD items passed on or before Nov All 2013 or Older projects Done or in-flight except one - Imminent and Eligible (and it is small) August 21st Roadmap update 2015 Reflects Adjustments (re-slotting) from the original Dec 2014 Roadmap for 2015 only 1 committed IT project at risk - (HLA) for delivery in 2015 OTHER Very Detailed information about versus actions and decision points Approved working ahead on organ allocation changes needed for the HOPE Act in order to implement in Oct Did not approve a project for Hope Act data collection. will be seeking to partner with participating organizations to collect these data outside of the UNet system. Gave high priority to the newly approved Cap on HCC Exception Score and Delay in HCC Score Assignment. Approved work on a DonorNet project to address technical debt and incorporate prioritized enhancements To accommodate HOPE Act we created a project to implement changes to the approved changes to serologies including those changes needed by the HOPE Act, we have also identified a minimal viable solution for the HOPE act and will begin implementation of these changes in April. We are also anticipate a policy change requiring the match to be rerun when serologies change (63603). We also created an HCC Project to implement the Cap on HCC and Delay in HCC Score Assignment and a DonorNet project. Both of these projects are anticipated to begin this summer. The DonorNet project will be worked in parallel with other board projects that affect DonorNet. We anticipate an effort to integration effort will be needed so that DonorNet enhancements will not be implemented until the beginning of 2016. In order accommodate the HOPE Act, DonorNet, and HCC projects the following projects have a later implementation date than previously reported: 55886 – Modify Pediatric Heart Allocation Dec 2015 – First Half 2016 39980 – Reinstate No Appeal/No withdrawal Jun 2015 – Nov 2015 We also separated the Require HLA C and DQB effort into two increments in order to gains some efficiencies and deliver value sooner. The first increment is scheduled for delivery on March 4 and includes warning users when they run matches with incomplete HLA and the automatically closing matches run with incomplete HLA. The second increment updates the labels for C and DQB throughout UNet. This effort has been combined with several other HLA related efforts into an HLA Project scheduled to run between April and November. Finally, we are keeping a close eye on the Vessel Disposition Reporting project. There have been concerns that the original vessels solution was too narrow and a more robust solution is being explored. Adding in June Board approved Projects Box Color Completed Underway non-BOD work Scheduled Text Color Projects Approved 2013 or prior Projects Approved 2014 Scheduled

20 Transplant Center Functionality
iPad User Acceptance Testing (UAT) – July 2015 Production release – Q4 Transplant Center Functionality Completed requirement gathering Start development – June 2015 Beta test (3 centers) – August 2015 At this point, 54% of OPOs have now received training and started to use Transnet – more than a dozen are using it for all phases of every donor. If you’ve been holding out, waiting for the iPad version, it’s nearly here! Go ahead and sign your team up for the December training and the iPad software will be ready when you get there. Additional features for use when transplant centers receive an organ are under development.

21 Board Project Service Level Objective
Approved projects start prior to next Board meeting No projects are ever older than 12 months Board Approval 50% of Projects Started 95% of 90% of Projects Complete 100% of Time T=0 T= 3 months T= 6 months T= 9 months T= 12 months UNOS IT is getting closer to a new Service Level Objective. by December of 2016, we aim to have : 50% of new board approved projects started within 3 months 95% started within 6 months 90% completed within 9 months And all of them completed within 12 months

22 IT Board Backlog by the End of…
23 Projects 2 Delivered 3 in progress 18 in queue 18 older than 12 months 44+ Projects 29 delivered 2 in progress 13+ in queue 3 older than 12 months ? Projects 15+ delivered ? in progress ? in queue 0 older than 12 months 2013 2014 2015 2016 35 Projects 7 Delivered 5 in progress 23 in queue 16 older than 12 months Despite starting to increase the pace at which the Board is approving new projects, the number of old projects continues to diminish.

23 Brian Shepard Chief Executive Officer Region 7 September 17, 2015
UNOS Update Brian Shepard Chief Executive Officer Region 7 September 17, 2015


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