Differences in the Opportunity for Transplantation within the US

1. Working Group 4: “Improve the Efficiency, Effectiveness, and Equity of the OPTN’s Policies and Processes” Differences in the Opportunity for Transplantation within the US Co-chairs: S. McDiarmid MD and K. Olthoff MD

2. M Barr MD A Benedi J Burdick MD B Cosimi MD R Freeman MD D La-Pointe-Rudow RN J Lake MD M Levy MD B Nuesse RN, BSN UNOS STAFF C Sommers JD M McBride P Oldham BSS P Schaeffer RN, BSN J Shaftel RN D Surlas RN R Wiesner MD H H Wong MD JD M Zamora MD GUESTS R Durbin MBA H Krakauer MD PhD A Leichtman MD G McBride RN MPH F Port MD PhD M Stegall MD Working Group 4 Members Thankyou!!

3. Differences in Transplantation in the US Ethical Imperative • Candidates for solid organ transplantation have life threatening disease • Given there are not enough available organs, the allocation and distribution of a life threatening resource should not advantage or disadvantage any one individual or group of individuals, with similar medical characteristics, over another

4. Differences in Transplantation in the US Federal Imperative – the Final Rule • “inter-transplant program variance to be as small as can be reasonably achieved in any performance indicator”

5. Differences in Transplantation in the US What determines variation in who gets transplanted? • Access to the list • Access to the donor organ What data demonstrates the major cause of differences in transplantation? What is the measure we should be trying to make more equitable?

6. Differences in Transplantation in the US Performance Indicators Common to all Organs • Access to the waiting list • Death (or removal ‘too sick’ for transplant) on waiting list • Rate of transplantation • Missed opportunities when active on the list • Rate of organ refusal • DSA performance • allocation efficiency

7. Differences in Transplantation in the US Performance Indicators can be evaluated for various patient groups: examples • Age • Ethnicity • Severity of illness • Diagnosis • Insurance status • Center effects • Patient location - geography

8. Differences in Transplantation in the US Current system of geographical boundaries which define patient location • UNOS defined regions. • Donor Service Areas (DSAs)

9. HI Differences in Transplantation in the US UNOS Regions 6 1 7 9 MA 10 RI 2 5 8 DE MD 3 11 4 PR & US VI

10. Differences in Transplantation in the US How were Regions established? • With establishment of the OPTN: for administrative and representative purposes • Intended to recognize existing relationships, local interests, and diversity across country • No intent necessarily to equalize populations or number of centers across the country

11. MA RI DE MD HI PR & US VI Differences in Transplantation in the US Donor Service Areas

12. Differences in Transplantation in the US How were DSAs established? • Generally intended as the first unit of organ distribution • DSA territories designated by CMS • Variable in terms of: - Number of transplant centers - Square mileage; inclusion of a part of a state, entire state, or multiple states - Population, candidate/donor ratios and characteristics, and procurement rates

13. Differences in Transplantation in the US Given different sources of possible variation why focus on geographic differences based on DSAs and UNOS regions? • Together they form the basis of the current allocation and distribution system for deceased donor organs. • Boundaries of DSAs and UNOS regions not developed for purposes of organ distribution - a system that is feasible to be changed • Most other variables – age, ethnicity, disease etc can not be changed with possible exceptions of insurance/payor status and center effects

14. Differences in Transplantation in the US As we consider geography: • Policies of organ distribution have been built on a basic principle of patient and donor location: • local first, region second, national last • Is this valid for all organs? • Iskidney different?

15. Differences in Transplantation in the US Patient Location – the effect of ‘geography’: Issues- • Who owns the organ – the locale in which it was recovered? “the unifying force of biology requires at least a national perspective” Henry Krakauer • Are patients harmed by geographic variations in access to transplantation? • Some regional variation is to be expected – how much is acceptable?

16. Differences in Transplantation in the US Who gets transplanted? Performance Indicator: Access to the Waiting List

17. Differences in Transplantation in the US Access to the Waiting Listing • Is this the purview of the OPTN/UNOS? • Is the scope of our concern only after a candidate is listed?

18. Differences in Transplantation in the US Access to the waiting list dependent on: • Incidence and prevalence of end-organ failure • Medical practice patterns • Referral patterns • Listing criteria • Patient education • Insurance/payor regional differences

19. Differences in Transplantation in the US Should the OPTN try to influence medical care and practice for patients eligible for transplantation? YES: Otherwise the benefit of transplantation is denied to this group of eligible, yet unlisted, eligible patients Within the scope of the Final Rule’s requirement to develop standardized listing criteria as well as policies to address socioeconomic impediments to transplantation

20. Differences in Transplantation in the US Available Data Evaluating Access to Waiting List • Quantitative for kidney – good data available from USRDS • Qualitative for heart and liver - based on an estimate of the incidence of end stage disease in a given population unit compared to the actual percent of the predicted eligible population actually listed

21. Alan Leichtman MD

29. Differences in Transplantation in the US

30. Differences in Transplantation in the US Who gets transplanted? Performance Indicators after listing • Death (removal) on the list • Transplant Rate - both can controlled for several variables such as age, diagnosis, medical urgency, geography Which variable(s) is most relevant?

31. Differences in Transplantation in the US Existing Differences in Performance Indicators after listing Given Final Rule emphasis to prioritize allocation of DD organs by medical urgency one approach to evaluating geographic differences should compare death on list and transplant rates by severity of illness

32. Differences in Transplantation in the US How is Medical Urgency Currently Defined? Organ Specific: • Liver: MELD/PELD system • Heart:: status categories – 1a,1b, 2 • Lung: risk of death without transplant • Kidney: net lifetime survival benefit??

33. Differences in Transplantation in the US Liver • MELD/PELD severity of illness has been well validated as an accurate measure of probability of death within 3 months of listing • In place since Feb 2002 • Extensive data already available examining regional and DSA differences in death waiting and rate of transplant

34. Probability of Transplant and Death/Too Sick within One Year for Adult Liver Registrations Added 3/1/2002-2/29/2004 By RegionInitial MELD Score 15+

35. Probability of Transplant and Death/Too Sick within One Year for Adult Liver Registrations Added 3/1/2002-2/29/2004 By DSAInitial MELD Score 15+

36. Differences in Transplantation in the US Heart: Severity of illness measured by status 1a, 1b, 2

37. Probability of Transplant and Death/Too Sick within One Year for Adult Heart Registrations Added 1/1/2002-12/31/2004 By RegionStatus 1A at Listing

38. Probability of Transplant and Death/Too Sick within One Year for Adult Heart Registrations Added 1/1/2002-12/31/2004 By DSAStatus 1A at Listing

39. Percent of Adult Heart Transplants Status 1Afor Transplants Performed During 1/1/04-6/30/05 by DSA

41. Differences in Transplantation in the US Kidney What is relevant measure of severity of illness? How can comparable patients be identified?

42. Probability of Transplant and Death/Too Sick within One Year for Adult Kidney Registrations Added 1/1/2002-12/31/2004 By RegionPRA < 20% at Listing

43. Probability of Transplant and Death/Too Sick within One Year for Adult Kidney Registrations Added 1/1/2002-12/31/2004 By DSAPRA < 20% at Listing

46. Differences in Transplantation in the US Pancreas • Unique in solid organ transplantation • The supply of solitary pancreata generally is greater than the demand • Simultaneous Pancreas and Kidney is limited primarily by the availability of the kidney • Major issues facing pancreas and islet allocation involve procurement and placement

47. Differences in Transplantation in the US Other Sources of Differences related to Geography • DSA Performance • Differences in donor quality

50. Differences in Transplantation in the US Conclusions from the Data • Patient location, as currently defined by Regions and DSAs, is the most important cause of differences in access to listing and transplantation • Is it right that where I live can dictate my chances of getting on a list, getting a transplant and of dying on the list