May 25, 2016 Dear Mrs. Walsh and Dr. Sweet, The liver redistricting proposal is to be offered for Public Comment in August as detailed in the minutes of the Liver and Intestine Committee Meeting of January 21, 2016. The premise of this proposal is that by better matching organ supply to waiting list demand, also known as listings, more lives are assumed to be saved. The developers predict that their proposal will result in similar allocation MELD scores across donor service areas and between the new regions. We have serious concerns about this proposal. These include the manner in which it was developed and the lack of consideration for the major negative consequences of implementation. We believe that these concerns must be addressed before this proposal goes out for Public Comment. We write to you requesting assistance in achieving this goal and detail our concerns regarding redistricting below. The underlying principal of redistricting is that normalizing allocation MELD scores leads to equity or, as the developers describe it, “justice” (1). MELD as a reliable predictor of mortality, however, applies only to the calculated laboratory MELD score and not to exception MELD scores (2,3). The allocation MELD score is a composite of both exception scores that vary greatly between regions and the true calculated laboratory MELD scores that do not; these will vary greatly between regions that will combine under redistricting (figure 1). With an over-representation of exception MELD scores in some regions, an overestimate in mortality risk is created in these regions and it is these same regions that stand to receive an increase in organ offers as a function of an artificial demand created through exceptions (Arrow A, figure 1)(2, 3). A more appropriate and unutilized metric to equalize wait list mortality is removal from the waiting list for disease progression or death. During the first forum, the transplant community overwhelmingly voted that waiting list survival should be a measured benefit in any new allocation policy, and maps should not be based solely on reducing the variation in median MELD at transplant. Collectively, these simple observations on metrics are a compelling argument against redistricting as a revision to the current allocation and distribution system. Multiple runs of the Liver Simulated Allocation Model (LSAM) to evaluate redistricting demonstrated at best a minimal (2%) decrease in waiting list deaths per year in the 4 district model nationally as compared to the existing system and even less (1%) in an 8-district model. However, to achieve even this goal, a variety of assumptions must be met with implementation of the policy. More importantly, the developers characterize not transplanting an appropriately listed patient and preferential allocation to a higher MELD as a ‘life saved’, which is not accurate. In fact, shifting organs from an appropriately listed patient with transplant benefit (MELD >16) leaves this patient to one of two outcomes: getting sicker to attain an offer or death while waiting. Merion established that a clear survival benefit exists for anyone transplanted with a calculated MELD score over 16 (4). Coupling the recent policy of Share 35 to redistricting leads to increased competition, which the developers suggest will lessen organ discards. LSAM, however, a tool used to predict what will occur based upon our past behaviors, predicts 200 fewer transplants with redistricting. Recent data shows competition in fact increases discards (5, 6). However, another validated function of increased competition is MELD inflation, which carries significant economic and outcome consequences and has not been reported in the developers’ analyses of the impact of the redistricting policy (7, 8, 9, 10). In summary both LSAM and literature predict a decline in the total number of transplants with redistricting, significant MELD escalation, significant increases in cost to OPOs, many transplant centers and to the system (8, 19, 22, 32). The final rule 121.8 paragraph 5, specifically states that a new system must be designed to preserve utility (11). Performing transplants in greater numbers of patients with MELD > 35 is inconsistent with the Final Rule as post-transplant mortality increases by greater than 5% (comparing outcomes for MELD >35 to outcomes for MELD 20-25) with this policy (9, 11). Interestingly it is the Final Rule that the developers use to justify a major change to the existing allocation system (1, 12). So when share 35 and redistricting are coupled, the simulated prediction of the 100 additional lives saved is exceeded by the 200 fewer transplants done per year and the additional (approximately) 60 or potentially more posttransplant lives lost. As such, redistricting is counter to both the top priority of the OPTN Board of Directors for 2015-2018 by resulting in fewer transplants and to the final rule 121.8 paragraph 5 on 2 points: “Shall be designed to avoid wasting organs” and to promote the efficient management of organ placement. A further unrecognized consequence of redistricting will be the impact on Simultaneous Liver and Kidney (SLK) Transplant rates that have increased 20% since Share 35 (9). Since 2001 and the introduction of MELD, SLKs have increased from 135 in 2001 to 629 in 2015. Under redistricting, LSAM, although not yet asked to model this, will predict a further increase in SLK transplants over time. Unfortunately, a consequence of redistricting will be increased waiting times and mortality rates on separate renal transplant wait lists. Decreasing access to lower KDPI kidneys that are usually more often allocated with SLKs carries additional consequences. We acknowledge that new work is being done to decrease SLKs, but these policies have yet to be implemented or proven effective. In the end, this policy will contribute to a larger opportunity cost borne by Medicare and those on the renal transplant wait list. These observations lead many to seriously question the concept of redistricting and we feel that the developers have underemphasized these impacts. At both public fora on redistricting, the transplant community emphasized that energy should be focused on increasing donation and improving the use of our current donor supply. Focusing on redistricting distracts from the only action that will save more lives and increase the number of transplants—increasing donation. Gentry et al. (13, 14) published two manuscripts stating that redistricting would balance and not shift organs from high to low performing OPOs. However, within their own manuscript, they acknowledge that shifts will occur. Unfortunately, several in the scientific community question the statistical methodology supporting their conclusion that no major shifts from high to low performing OPOs will occur. Unfortunately, the inability to publically question their data is created by an under-recognized editorial bias that is not uncommon within the editorial process (15). A balance of opinion must be attained and all parties provided a voice to develop the optimal policy. It is disappointing to also note that the SRTR has not yet assisted Professor Sanjay Mehrotra by providing him access to LSAM as they stated they would. Any model that compromises donation warrants great scrutiny (16, 17). The Gentry model uses current waiting list numbers and not incidence of disease. In addition, the model ignores access to the wait list for that population and waiting list mortality once listed. The model will remove some of the incentive to improve donor identification and utilization in underperforming donor service areas (DSAs) by supplementing their poor performance with additional organs from other better performing DSAs (13,14, 25). Redistricting also penalizes underserved areas, in particular the South, where access to transplantation waiting lists and the potential to survive when on a wait lists is lower (Figure 2) (18). With redistricting, OPOs will see a shift in charges for organs and some OPOs subjected to significant financial consequence as outlined by Kappel, et. al. (19). With these additional costs to OPOs’, resources will need to shift from efforts to increase donation to other administrative and cost containment actions required to offset the economic impact of the redistricting policy. Behavioral economics indicate that increasing supply to an area with high demand leads to behaviors that maintain demand as described by Nash. Physician and institutional behaviors have been demonstrated to align with behaviors that increase revenues (20) and this competitive behavior illustrated to have negative consequences (21). Our concern is that under a veil of saving more lives, centers will more aggressively list and thereby further drive demand. This action however will likely disadvantage other areas within the same new super-region. Another major concern with negative impact, documented in JAMA, will occur in Veterans awaiting transplantation. The Veterans Affairs (VA) System has waitlist mortality rates higher than the general waitlist for any given MELD score (18). Therefore, should the MELD score in VA systems rise, which will occur for the three largest VA programs in the country under redistricting, a disproportionate increase in wait list mortality will occur for the VA. No data exists on exactly how redistricting will impact the VA system’s waiting list population or finances. This is also true for center level data in regions that will do fewer transplants following redistricting. The community remains deeply divided on redistricting as a function of the many elements identified during three years of data presentation, analyses, and debates. These important issues have not been adequately analyzed or mitigated in the design of the current policy and their potentially negative impact is an unacceptable oversight. All parties have a conflict of interest when presenting their position on the subject as, “a conflict of interest is a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”(24). The developers of redistricting have consistently denied a conflict of interest but by this definition they may be the most conflicted. In drafting this letter, we acknowledge our conflicts and confine our arguments to seeking no greater a number of lives lost, no MELD escalation and our concerns regarding the many economic consequences of this policy. We agree with the concept of greater sharing to address inequity, but we do not feel redistricting solves this problem. With redistricting we predict an increase in mortality from end stage liver disease, most noticeably in the South. This increase in mortality will occur when donated organs are redirected from areas with a high incidence of liver disease and limited community resources to areas with a high incidence of wait listing and extensive community resources to support the wait listed population. Those with greater resources live in the Northeast and benefit by greater “liver flow” with redistricting, while those without resources are in the South (figure 2) and stand to see a reduction in transplant numbers. This unfortunate result of the redistricting concept creates an inequity in the chance at living. Focusing our communal energy and resources to increasing donation and maximizing organ utilization will save more lives by providing a greater number of transplant opportunities rather than shuffling who gets the existing opportunity. If underperforming DSAs in regions of low donation are given assistance, an increase in all transplants would occur (25). By reducing discard rates and increasing utilization we will better address the inequities of geography (5, 26). However when the creators of redistricting describe "Gerrymandering for Justice" (1), and when a trail of papers appear in the press satisfying the criteria for publication bias (15), it becomes imperative for UNOS to investigate and assure the community that the policy and those that develop it have been impartial and unbiased in their position. Based on these concerns, we request that the UNOS board: 1. Instruct the liver intestine committee to abandon consideration of nationwide redistricting proposals and consider alternative solutions to address disparities. 2. Develop a model of allocation that incorporates metrics of fairness, utility, and value, including waiting-list mortality and long-term survival to optimize utility. 3. Allow time for recent policy revisions like share 35, sodium MELD, HCC exception revisions and the National Review Board to be implemented and studied before implementing further changes. 4. Perform appropriate and detailed impact analyses and vulnerability assessments on any proposal, including but not limited to logistical difficulties, economic consequences, effects upon smaller centers and rural communities, women, VA patients and VA programs. 5. Arrange for LSAM assumptions, input and output data be validated by external and impartial parties. 6. When using LSAM to predict outcomes, use data current rather than data unrelated to existing policies. 7. Accept that parties have heuristics and biases and these can only be managed through a balanced, more diversified and transparent process of data presentation and publication. 8. Direct energies and refine existing policies to facilitate increasing organ supply and reward its utilization. In contrast to the liver transplant era before the final rule, when donation well exceeded concerns regarding appropriate allocation, we are now in an era when demand exceeds supply in all areas of the country (i.e. we are resource constrained). Required, then, are policies that allocates to those with survival benefit, (i.e optimizes utility), rather than changing to a system that reduces the total number of transplants at a higher cost. We must explore all efforts to increase the donor pool and to this increased pool also seek policies and practices that enhance the utilization of these precious resources. In the end, it is only through a larger resource that we will realistically save more lives as redistricting in the end only alters where the life waiting is lost. Sincerely, Alabama Joseph Tector, MD Professor of Surgery Director, Xenotransplant Institute Division of Transplantation Department of Surgery The University of Alabama at Birmingham School of Medicine Birmingham, AL Arkansas Daniel Borja-Cacho, MD Surgical Director, Liver Transplantation Department of Surgery University of Arkansas for Medical Sciences Little Rock, AR Colorado Igal Kam, MD Chief of Transplant Surgery Professor of Surgery Division of Transplant Surgery University of Colorado School of Medicine Anschutz Medical Campus Aurora, CO Kian A. Modanlou, MD, FACS Surgical Director, Liver Transplant Porter Adventist Hospital Transplant Center Denver, CO Florida Ken Andreoni, MD Interim Chair, Division of Transplantation Department of Surgery University of Florida Health College of Medicine Gainesville, FL Georgia Joseph F. Magliocca, MD, FACS Surgical Director, Liver Transplantation Associate Professor of Surgery Department of Surgery, Division of Transplantation Emory Transplant Center and Children’s Healthcare of Atlanta Atlanta, GA Harrison S. Pollinger, D.O., FACS Program Director, Piedmont Transplant Institute Surgical Director of Liver Transplantation Piedmont Healthcare Atlanta, GA Hawaii Linda L. Wong, M.D. Director, Liver Transplant Program Queen’s Medical Center Honolulu, HI Illinois Michael M. Abecassis, MD, MBA, FACS, FRCS(C), FACPE J. Roscoe Miller Distinguished Professor Departments of Surgery and Microbiology-Immunology Chief, Division of Organ Transplantation Founding Director, Comprehensive Transplant Center Dean, Clinical Affairs Feinberg School of Medicine Northwestern University Chicago, IL Indiana Jonathan A. Fridell, MD, FACS Professor of Surgery Surgical Director, Liver & Pancreas Transplantation Chief Medical Officer, IU Health Transplant Institute Interim Chief, Division of Transplant Surgery Indiana University School of Medicine Indianapolis, IN Kellie Hanner President/CEO Indiana Donor Network Indianapolis, IN Iowa Kenneth P. Kates, MBA Chief Executive Officer, University of Iowa Hospitals and Clinics Associate Vice President, University of Iowa Health Care Iowa City, IA Alan Reed, MD, MBA Professor and Chief, Division of Transplant and Hepatobiliary Surgery Director, UIHC Organ Transplant Center University of Iowa Hospitals and Clinics Iowa City, IA Kansas Timothy M. Schmitt, MD Director, Center for Transplantation Assistant Professor of Surgery and Internal Medicine The University of Kansas Hospital Kansas City, KS Kentucky Christopher M. Jones, MD, FACS Associate Professor of Surgery Director, Section of Hepatobiliary and Transplant Surgery Chief, Liver Transplantation University of Louisville/Jewish Hospital Louisville, KY Malay Shah, MD Surgical Director, Liver Transplantation Program Assistant Professor of Surgery Transplant Center University of Kentucky HealthCare Lexington, KY Louisiana Joseph F. Buell, MD, MBA, FACS Professor of Surgery and Pediatrics Director, Abdominal Transplant Institute Hepatobiliary Surgery and Oncology Department of Surgery Tulane University School of Medicine New Orleans, LA Pam Gillette, MPH, RN, FACHE Vice President, Transplant Tulane University School of Medicine New Orleans, LA Mary Killackey, MD, FACS Associate Professor of Surgery and Pediatrics Tulane University School of Medicine New Orleans, LA George E. Loss, Jr., MD, FACS, PhD Associate Medical Director and System Chairman, Department of Surgery Chief, The Ochsner Multi-Organ Transplant Institute New Orleans, LA Anil Paramesh, MD, FACS Associate Professor of Surgery, Urology and Pediatrics Tulane University School of Medicine New Orleans, LA Kelly Ranum Chief Executive Officer Louisiana Organ Procurement Agency Metairie, LA Gazi B. Zibari, MD, FACS Director, John C. McDonald Regional Transplant Center Director, WK Advanced Surgery Center Willis-Knighton Health System Shreveport, LA Michigan Marwan S. Abouljoud, MD, FACS Benson Ford Chair Director, Transplant Institute Division of Transplant and Hepatobiliary Surgery Department of Surgery Henry Ford Hospital Detroit, MI Mississippi Christopher D. Anderson, MD, FACS James D. Hardy Professor Chair, Department of Surgery Chief, Division of Transplant and Hepatobiliary Surgery The University of Mississippi Medical Center Jackson, MS M. Kevin Stump President / CEO Mississippi Organ Recovery Agency Flowood, MS Missouri Diane Brockmeier President & CEO Mid-America Transplant St. Louis, MO William Chapman, MD, FACS Eugene M. Bricker Chair of Surgery Professor and Chief, Section of Transplantation Chief, Division of General Surgery Surgical Director, Transplant Center Washington University School of Medicine St. Louis, MO Jameson Forster, MD, FACS Medical Director, Abdominal Transplant Saint Luke’s Hospital of Kansas City Kansas City, MO Henry B. Randall, MD, FACS Director, Abdominal Transplant Center Saint Louis University Hospital St. Louis, MO North Carolina Lon Eskind, MD Surgical Director, Liver Transplant Carolinas HealthCare System Charlotte, NC David A. Gerber, MD, FACS Chief and Professor of Surgery Director, Division of Abdominal Transplantation Department of Surgery The University of North Carolina Chapel Hill, NC Lloyd Jordan Chief Executive Officer Carolina Donor Services Durham, NC Mark Russo, MD Medical Director, Liver Transplant Carolinas HealthCare System Charlotte, NC Ohio Barry C. Massa Executive Director LifeCenter Organ Donor Network Cincinnati, OH Shimul A. Shah, MD, MHCM Associate Professor of Surgery Director, Liver Transplantation and Hepatobiliary Surgery Department of Surgery Division of Transplantation University of Cincinnati Cincinnati, OH Marti Taylor, MSN, RN Chief Executive Officer, University Hospital Executive Director, The Richard M. Ross Heart Hospital Wexner Medical Center The Ohio State University Columbus, OH Oklahoma Vivek Kohli, MD, FACS Director, Liver Transplant & Hepatobiliary Pancreas Surgery INTEGRIS Health Nazih Zuhdi Transplant Institute Oklahoma City, OK Oregon Susan L. Orloff, MD, FACS, FAASLD Professor of Surgery Chief and Director, Abdominal Organ Transplantation/Hepatobiliary Surgery Adjunct Professor, Molecular Microbiology& Immunology Oregon Health & Science University Chief, Portland VA Medical Center Transplant Program Portland, OR South Carolina Prabhakar K. Baliga, MD, FACS Fitts-Raja Professor of Surgery Chairman, Department of Surgery Medical University of South Carolina Charleston, SC Amy Hauser Administrator, Transplant Center Medical University of South Carolina Charleston, SC Nancy A. Kay President/CEO LifePoint, Inc. North Charleston, SC Tennessee Douglas W. Hanto, MD, PhD Director, Vanderbilt Transplant Center Professor of Surgery, Department of Surgery Chief, Pediatric Liver Transplant Program Monroe Carell Jr. Children’s Hospital at Vanderbilt Vanderbilt University Medical Center Nashville, TN Texas Jeffrey Fair, MD Director, Transplant Programs The University of Texas Medical Branch Galveston, TX Glenn Halff, MD Professor of Surgery Dielmann Chair in Transplant Sciences Director, Transplant Center University of Texas Health Science Center San Antonio, TX Göran B. Klintmalm, MD, PhD, FACS Chief and Chairman Annette C. and Harold C. Simmons Transplant Institute W.W. Caruth Jr., Chair in Organ Transplantation Immunology Vice Chair, Department of Surgery Division Chief, Transplant Surgery Professor of Surgery, Texas A&M College of Medicine Baylor University Medical Center Dallas, TX Patricia Niles President and CEO Southwest Transplant Alliance Dallas, TX Teresa Shafer, RN, MSN, CPTC President Texas Transplantation Society, Inc. Austin, TX Virginia Douglas M. Heuman, MD, FACP, FACG, AGAF, FAASLD Professor of Medicine, Virginia Commonwealth University Chief, Hepatology and Liver Transplantation Hunter Holmes McGuire Department of Veterans Affairs Medical Center Richmond, VA Tim Jankiewicz Vice President and Executive Director LifeNet Health OPO Virginia Beach, VA Marlon Levy, MD, FACS Professor and Chairman Hume-Lee Transplant Center Division of Transplantation Surgery Virginia Commonwealth University Richmond, VA Shawn J. Pelletier, MD Associate Professor of Surgery Surgical Director, Liver Transplantation University of Virginia Health System Charlottesville, VA Washington Jorge D. Reyes, M.D. Roger K Giesecke Distinguished Professor Professor and Chief Division of Transplant Surgery Department of Surgery University of Washington Medicine Seattle, WA Wisconsin Mike Anderson Executive Director University of Wisconsin Organ and Tissue Donation Madison, WI Dixon B. Kaufman, MD, PhD Ray D. Owen Professor and Chair Department of Surgery Division of Transplantation University of Wisconsin School of Medicine and Public Health Madison, WI Figure 1: A Black arrows point to median laboratory MELD scores in regions that combine under a 4 district model Arrow [A] shows direction of m ovement of livers created by artificial the MELD inflation created by exceptions Figure 2: References with supporting data. 1. Gentry S, Chow E, Massie A, Segev D. Gerrymandering for Justice: Redistricting U.S. Liver Allocation. Interfaces 2015. 45(5):462-480. 2. Berry K, Ioannou GN. Comparison of Liver Transplant-Related Survival Benefit in Patients With Versus Without Hepatocellular Carcinoma in the United States. Gastroenterology. 2015 Sep;149(3):669-80; quiz e15-6. doi: 10.1053/j.gastro.2015.05.025. Epub 2015 May 27. 3. Northup PG, Intagliata NM, Shah NL, Pelletier SJ, Berg CL, Argo CK. Excess mortality on the liver transplant waiting list: unintended policy consequences and Model for EndStage Liver Disease (MELD) inflation. Hepatology. 2015 Jan;61(1):285-91. doi: 10.1002/hep.27283. Epub 2014 Oct 29. 4. Merion RM, Schaubel DE, Dykstra DM, Freeman RB, Port FK, Wolfe RA. The survival benefit of liver transplantation. Am J Transplant. 2005;5:307–313. 5. Goldberg DS, French B, Lewis JD, Scott FI, Mamtani R, Gilroy R, Halpern SD, Abt PL. Liver transplant center variability in accepting organ offers and its impact on patient survival. Journal of Hepatology. 2015 Nov 25. pii: S0168-8278(15)00773-4. doi: 10.1016/j.jhep.2015.11.015. [Epub ahead of print] 6. Skaro AI, Hazen G, Ladner D, Kaplan B. Organ Transplantation: An Introduction to Game Theory. Transplantation. 2015 Jul;99(7):1316-20. 7. Adler JT, Yeh H, Markmann JF, Nguyen LL. Market Competition and Density in Liver Transplantation: Relationship to Volume and Outcomes. 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