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Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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Realizing the Promise of Equity in
the Organ Transplantation System

Kenneth W. Kizer, Rebecca A. English, Meredith Hackmann, Editors

Committee on A Fairer and More Equitable, Cost-Effective, and Transparent System
of Donor Organ Procurement, Allocation, and Distribution

Board on Health Sciences Policy

Board on Health Care Services

Health and Medicine Division

A Consensus Study Report of

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THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by Contract No. HHSN263201800029I/75N98020F00011 between the National Academy of Sciences and The National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-27072-4
International Standard Book Number-10: 0-309-27072-3
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Realizing the promise of equity in the organ transplantation system. Washington, DC: The National Academies Press. https://doi.org/10.17226/26364.

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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COMMITTEE ON A FAIRER AND MORE EQUITABLE, COST-EFFECTIVE, AND TRANSPARENT SYSTEM OF DONOR ORGAN PROCUREMENT, ALLOCATION, AND DISTRIBUTION

KENNETH W. KIZER (Chair), Chief Healthcare Transformation Officer and Senior Executive Vice President, Atlas Research

ITAI ASHLAGI, Associate Professor, Stanford University

CHARLES BEARDEN, Senior Organ Transplant Coordinator, Clinical Consulting Associates

YOLANDA T. BECKER, Professor of Surgery, University of Chicago (until September 2021)

ALEXANDER CAPRON, University Professor, Scott H. Bice Chair in Healthcare Law, Policy, and Ethics, and Professor of Medicine and Law, University of Southern California

BERNICE COLEMAN, Director, Nursing Research Department and Assistant Professor, Biomedical Sciences, Cedars-Sinai

LEIGH ANNE DAGEFORDE, Transplant Surgeon and Assistant Professor, Massachusetts General Hospital, Harvard Medical School

SUE DUNN, Chief Executive Officer (Retired), Donor Alliance (Former)

ROBERT GIBBONS, Blum-Riese Professor of Biostatistics, The University of Chicago

ELISA J. GORDON, Professor, Department of Surgery, Center for Health Services and Outcomes Research, Center for Bioethics and Medical Humanities, Northwestern University Feinberg School of Medicine

RENÉE M. LANDERS, Professor and Director, Health Law, Faculty Director, Law Life Sciences, Suffolk University

MARIO MACIS, Professor, Carey Business School, Johns Hopkins University

JEWEL MULLEN, Associate Dean for Health Equity, University of Texas at Austin, Dell Medical School

NEIL R. POWE, Chief of Medicine, Zuckerberg San Francisco General Hospital, and Professor of Medicine, University of California, San Francisco

DORRY SEGEV, Marjory K. and Thomas Pozefsky, Professor of Surgery and Epidemiology, Johns Hopkins University1

DENNIS WAGNER, Principal and Managing Director, Yes And Leadership, LLC

JAMES YOUNG, Executive Director of Academic Affairs, Cleveland Clinic; Professor of Medicine and Vice-Dean for Academic Affairs, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University George & Linda Kaufman Chair, Heart & Vascular Institute

Study Staff

REBECCA A. ENGLISH, Study Director

AMANDA WAGNER GEE, Program Officer (until November 2021)

SIOBHAN ADDIE, Program Officer (until August 2021)

MEREDITH HACKMANN, Associate Program Officer

ELIZABETH TOWNSEND, Associate Program Officer (until October 2021)

EMMA FINE, Associate Program Officer

DEANNA GIRALDI, Associate Program Officer (from October 2021)

RUTH COOPER, Associate Program Officer (from June 2021)

___________________

1 As of February 1, 2022, Dr. Segev is Professor of Surgery and Population Health and Vice Chair for Research in the Department of Surgery, New York University.

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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KENDALL LOGAN, Senior Program Assistant (until July 2021)

CHRISTIE BELL, Finance Business Partner

ANDREW POPE, Director, Board on Health Sciences Policy

SHARYL NASS, Director, Board on Health Care Services

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by BOBBIE BERKOWITZ, University of Washington, and SARA ROSENBAUM, George Wash-

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ington University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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Acknowledgments

The study committee and project staff would like to thank the study sponsor, the National Institutes of Health, for their leadership in the development of this study. The committee wishes to express its particular gratitude to the patients and family members who shared their stories and advice with the committee. The committee also wishes to thank the many individuals who participated in public workshops and shared their expertise throughout the course of the study.

The committee thanks the authors whose commissioned papers provided valuable information and analysis for the committee including Abigail Alyesh, Yolanda Becker, Robert Gibbons, Kathleen Giblin, Allie Herr, Kim Ibarra, Samantha Klitenic, Elaine Ku, Jennifer Lai, Carolee Lantigua, Macey Levan, Sumit Mohan, Josh Mooney, William Parker, Chris Queram, Jesse Schold, and Sri Lekha Tummalapalli. The committee also acknowledges the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services (CMS) for verifying for accuracy relevant technical content pertaining to the Organ Procurement and Transplantation Network and to CMS programs related to transplantation. The committee is grateful for the many staff within the Health and Medicine Division who provided support for the project. Special thanks are extended to Rebecca Morgan, senior librarian, who compiled literature searches and provided fact checking assistance; Christie Bell, the financial business partner; and Mark Goodin, for his editorial assistance provided in preparing the final report.

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Preface

Since the first successful kidney transplant was performed in 1954, organ transplantation has become a lifesaving treatment for a growing number of conditions. Each year, the individuals and organizations in the U.S. organ donation, procurement, allocation, and distribution system work together to provide lifesaving transplants to many thousands of persons, but thousands more will die before getting a transplant because of the ongoing shortage of deceased donor organs. The combination of deceased donor organs as a scarce resource and the high value of transplantation—both for individual patients and their families and for society broadly—creates a setting for high-stakes health care decision making.

While the U.S. deceased donor organ transplantation system benefits tens of thousands of individuals each year, the system is demonstrably inequitable. Too many persons, especially in minority and underserved populations, are disadvantaged in accessing the services that lead to transplantation, and experience worse outcomes than others. Across the country, donor hospitals and organ procurement organizations have dramatically different performance in identifying potential donors and procuring organs. Transplant centers differ significantly in the rates of accepting or declining organs on behalf of patients on their waiting list and struggle to make individual transplant center- and patient-level decisions that reflect the best use of organs on a national scale. Overall, the transplantation system—donor hospitals, organ procurement organizations, transplant centers, regulators, payers—has much work to do to improve fairness and equity in who receives an organ transplant.

Akin to the changes implemented to improve patient safety and health care quality over the past 25 years, we know that improving the performance of the health care system for patient benefit is possible. The transplantation system is composed of many dedicated and committed professionals trying to do their best, but the overall organ transplantation system is not producing the synergistic results that we should expect from it. As a nation, we must do better.

This study—focused on increasing fairness, equity, cost-effectiveness, and transparency in the deceased donor organ procurement, allocation, and distribution system—occurs at a time when the transplantation system is under intense scrutiny, and thus, at an opportune

Suggested Citation:"Front Matter." National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The National Academies Press. doi: 10.17226/26364.
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time for making significant change. In this report we discuss multiple changes that would create a more equitable organ transplantation system, beginning with reconceptualizing the system as beginning well before an individual is added to an organ transplant waiting list. Because many individuals from minority and underserved populations, as well as women, are never added to the waiting list, bringing these individuals into the system, combined with improved fairness in the allocation policies that govern how patients are prioritized on the waiting list, would help create a more equitable system.

During the committee’s deliberations, some members were startled by the statistics showing the large number of donated organs that are never transplanted—and especially by the lack of transparency that accompanies organ offer acceptance or decline decisions. Most individuals on the waiting list are never made aware of the organ offers that are declined on their behalf. Of course, there are appropriate reasons based on sound medical judgment for a transplant team to decline an organ offered to a particular patient, but there also are many instances when the process would benefit from bringing the patient into the decision-making process. The benefits of shared decision making with patients have been proven and incorporating more shared decision making into organ offer processes would provide an opportunity for the transplantation system to be more transparent and accountable.

In responding to the study’s broad task—which includes looking into policy-making processes, allocation modeling, and quality improvement processes and performance metrics—this report provides an overview of the current organ transplantation system and advances multiple near- and longer-term actionable recommendations to improve fairness, equity, transparency, and cost-effectiveness.

The committee’s work was informed by and materially benefited from the compelling insights shared by individuals waiting for a donor organ, transplant recipients, families of individuals who had donated organs, individuals and organizations advocating on behalf of minority or marginalized individuals, the disabled, women, and rural populations needing transplants, and organizations and associations working in transplantation every day. We carefully reflected on the comments received and the possibilities for improving access to transplantation, especially for those who have historically experienced difficulties in gaining access to the system.

The committee greatly appreciated the information provided by workshop speakers and the many others who shared information with the committee. The feedback from the report reviewers was invaluable. And, we especially thank the study sponsor, the National Institutes of Health, for its work in organ transplantation and for its support of this study.

It was my great privilege to work with such dedicated committee members, each of whom thoroughly engaged in the study, generously shared their expertise, and contributed substantial time and effort to the endeavor. This was a complex task, and the committee members stepped up to meet the challenge. Their reasoned and thoughtful discussions made this report possible. The committee was very fortunate to work with a diligent and outstanding team of National Academies of Sciences, Engineering, and Medicine staff, and we deeply thank Rebecca English, Meredith Hackmann, Deanna Giraldi, Elizabeth Townsend, Amanda Wagner Gee, Emma Fine, Ruth Cooper, Siobhan Addie, and Kendall Logan, led by Andrew Pope and Sharyl Nass, board directors in the Health and Medicine Division. We also thank Anna Nicholson and Jon Weinisch for writing and editing work as well as the National Academies’ library staff for assistance in conducting detailed literature searches for the committee and staff.

The committee considered a large body of evidence on the components of the organ transplantation system and worked to develop this report in an objective manner. The committee was cognizant of the large amount of data reported on organ transplantation but was

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surprised at the gaps in knowledge in some areas. For instance, why do so many individuals who ostensibly would be candidates for organ transplantation not gain access to the waiting list? Disaggregated data by race and ethnicity, gender/sex, age, and language are needed to better understand current inequities so that appropriate interventions can demonstrably improve the system and make it more equitable.

As requested in the study charge, the committee also considered the Organ Procurement and Transplantation Network (OPTN) policy-making process and opportunities for improving it. While the steps in the general policy-making process are well documented, the dynamics of the OPTN committee interactions and the true impact on final policies was not always clear. The OPTN is not alone in its efforts to work with a broad range of stakeholders to craft policies to complicated and contentious issues in health care and the policy-making process for organ procurement, allocation, and distribution should be informed by the expertise and experience of other entities.

Overall, we are confident system improvement is possible and are hopeful for the future.

Kenneth W. Kizer, Chair
Committee on A Fairer and More Equitable, Cost-Effective,
and Transparent System of Donor Organ Procurement,
Allocation, and Distribution

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3 FOUNDATIONS FOR A TRUSTWORTHY DECEASED DONOR ORGAN TRANSPLANTATION SYSTEM

Why Is Trustworthiness Important?

Ethical Principles and Theories for a Trustworthy System

The Relevance of Ethical Principles for the Organ Transplantation System

Transparency: An Instrumental Value For a Trustworthy System

References

4 CONFRONTING AND ELIMINATING INEQUITIES IN THE ORGAN TRANSPLANTATION SYSTEM

Prioritizing Health Equity in the Transplantation System—Why Is This Important?

Striving for Health Equity and Fairness in Organ Transplantation

Data Challenges Related to Assessing and Assuring Equity

Structural Barriers to Equity in the Pathway to an Organ Transplant

Improving Quality and Health Equity Across the Entire Organ Transplantation System

Evidence-Based Interventions for Improving Health Equity in the Organ Transplantation System

References

5 SAVING MORE LIVES AND ENHANCING EQUITY WITH DECEASED DONOR ORGAN ALLOCATION POLICIES

Disparities Exacerbated by Allocation Scoring Systems

Current Allocation Policies and Scoring Systems

Survival Benefit of Transplantation

Modeling Allocation Policy Changes

Information Technology Infrastructure Opportunities

References

6 IMPROVING PROCUREMENT, ACCEPTANCE, AND USE OF DECEASED DONOR ORGANS

Increasing Deceased Organ Donation and Procurement

OPO Regulatory Framework and Performance Metrics

Key Area for Improvement for OPOs: Donation After Circulatory Determination of Death

Transplant Center Regulatory Framework and Performance Metrics

Key Area for Improvement for Transplant Centers: Organ Use

Key Area for Improvement for Transplant Centers: Organ Offer Acceptance

Donor Care Units

References

7 MEASURING AND IMPROVING SYSTEM PERFORMANCE

OPTN Measurement Challenges

Dashboard of Standardized, Consensus-Based Performance Measures

Quality Improvement in Organ Donation and Transplantation

Aligning Incentives to Maximize Organ Use

References

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FIGURES

1-1 Transplant patient journey showing each step in the journey as well as the institutions responsible for creating the resources, setting the policies, or providing patients with the services that are relevant to that step

2-1 Relationship between HHS, HRSA, the OPTN, the OPTN contractors, and SRTR contractors

2-2 Hospital-acquired conditions rate per 1,000 hospital discharges, United States, 2010–2017

2-3 The OPTN 10-step policy development process

2-4 Average time from committee project approval to board approval

2-5 Organs recovered for transplant and not transplanted (2019)

4-1 Known disparities in the organ transplantation pathway

4-2 A proposed framework for infusing equity, value, and transparency across the deceased donor organ transplantation system

5-1 Number of deceased candidates with offers by year

5-2 Continuous distribution allocation framework

5-3 Percentage of preemptive transplants grouped by racial or ethnic groups

5-4 Five-year survival benefit for the median recipient on dialysis compared to a preemptive transplant

6-1 DCDD donors recovered in the United States: 1992–2021

6-2 DCDD organs transplanted in the United States by donor type: 1992–2021

6-3 Variability in percent of donation after determination of circulatory death (DCDD) donors by OPO

6-4 Proportion and number of nonused deceased donor kidneys (1987–2021)

6-5 Significant overlap exists in the quality of kidneys transplanted and not used

6-6 Rate and odds of discard of deceased donor kidneys over the course of the week, 2000–2013

6-7 Mean sequence number of accepted offer and adjusted odds of becoming a hard-to-place kidney (acceptance sequence number > 100) were higher on the weekend for transplanted deceased donor kidneys from 2008 to 2015

6-8 Variation in offer acceptance rate ratios by organ type

6-9 The distribution of adjusted center-level probability of deceased donor kidney transplant within 3 years of wait listing in 2015 varied considerably nationwide, ranging from 4.0% to 64.2%

6-10 Range in adjusted center-level probability of deceased donor kidney transplant within 3 years of wait listing in 2015 showing significant variation within and across DSAs

6-11 Example of a tool estimating survival benefit of accepting an offered kidney versus waiting for a different offer to support incorporating patient preferences into decisions

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Acronyms and Abbreviations

CMS Centers for Medicare & Medicaid Services
CPRA calculated panel reactive antibody
DCDD donation after circulatory determination of death
DCU donor care unit
DDKT deceased donor kidney transplant
DNDD donation after neurological determination of death
DSA donor service area
eGFR estimated glomerular filtration rate
EPTS estimated posttransplant survival
ESKD end-stage kidney disease
HCV hepatitis C virus
HHS U.S. Department of Health and Human Services
HLA human leukocyte antigen
HRSA Health Resources and Services Administration
IOM Institute of Medicine
KAS kidney allocation system
KDPI Kidney Donor Profile Index
LAS lung allocation score
LDKT living donor kidney transplantation
LOS length of stay
MELD Model for End-Stage Liver Disease
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NHBD non–heart-beating donor
NOTA National Organ Transplant Act
NQF National Quality Forum
OPO organ procurement organization
OPTN Organ Procurement and Transplantation Network
PELD Pediatric End-Stage Liver Disease
QALY quality-adjusted life year
SAM simulated allocation model
SDOH social determinants of health
SES socioeconomic status
SRTR Scientific Registry of Transplant Recipients
UNOS United Network for Organ Sharing
USRDS United States Renal Data System
VAD ventricular assist device
VCA vascularized composite allotransplantation
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Each year, the individuals and organizations in the U.S. organ donation, procurement, allocation, and distribution system work together to provide transplants to many thousands of people, but thousands more die before getting a transplant due to the ongoing shortage of deceased donor organs and inequitable access to transplant waiting lists.

Realizing the Promise of Equity in the Organ Transplantation System, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine’s Committee on A Fairer and More Equitable, Cost-Effective, and Transparent System of Donor Organ Procurement, Allocation, and Distribution, provides expert recommendations to improve fairness, equity, transparency, and cost-effectiveness in the donor organ system.

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