Organ Procurement and Transplantation

Assessing Current Policies and the Potential Impact of the DHHS Final Rule

Committee on Organ Procurement and Transplantation Policy

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Organ Procurement and Transplantation Assessing Current Policies and the Potential Impact of the DHHS Final Rule Committee on Organ Procurement and Transplantation Policy Division of Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the General Accounting Office (Contract No. N00014-98-1-0789) and the Greenwall Foundation (Award No. 3302). The views presented in this report are those of the Committee on Organ Procurement and Transplantation Policy and are not necessarily those of the funding organizations. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on Organ Procurement and Transplantation Policy. Organ procurement and transplantation : assessing current policies and the potential impact of the DHHS final rule / Committee on Organ Procurement and Transplantation Policy, Division of Health Sciences Policy, Institute of  Medicine. p. ; cm. Includes bibliographical references and index. ISBN 0-309-06578-X (casebound) 1. Procurement of organs, tissues, etc.--Law and legislation--United States. 2. Transplantation of organs, tissues, etc.--Law and legislation--United States. I. Title. [DNLM: 1. Organ Procurement--legislation & jurisprudence--United States. 2. Health Services Accessibility--United States. 3. Organ Transplantation--legislation & jurisprudence–United  States. 4. Tissue  Donors–legislation &  jurisprudence--United States. WO 690 I59o 1999] RD129.5 .I57 1999 362.1'783'0973--dc21 99-044515 The full text of this report is available on-line at www.nap.edu/readingroom. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 1999 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule COMMITTEE ON ORGAN PROCUREMENT AND TRANSPLANTATION POLICY EDWARD D. PENHOET (Chair), Dean, School of Public Health, University of California at Berkeley NAIHUA DUAN, Statistics Group, RAND Corporation, Santa Monica (until May 6, 1999) NANCY NEVELOFF DUBLER, Director, Division of Bioethics, Montefiore Medical Center, Professor of Bioethics, Albert Einstein College of Medicine, New York CHARLES K. FRANCIS, President, Charles R. Drew University of Medicine and Science, Los Angeles ROBERT D. GIBBONS, Professor of Biostatistics, Departments of Biostatistics and Psychiatry, University of Illinois at Chicago BARBARA GILL, Clinical Nurse Specialist, Abilene Cardiothoracic and Vascular Surgery of Texas, Abilene EVA GUINAN, Associate Professor of Pediatrics, Harvard Medical School, Boston MAUREEN HENDERSON, Professor Emeritus of Epidemiology and Medicine, University of Washington, Seattle SUZANNE T. ILDSTAD, Director, Institute for Cellular Therapeutics, University of Louisville PATRICIA A. KING, Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy, Georgetown University, Washington, D.C. MANUEL MARTINEZ-MALDONADO, Vice Provost for Research and Professor of Medicine, Oregon Health Sciences University, Portland GEORGE E. MCLAIN, Assistant Chief of Anesthesiology, Martin Memorial Medical Center, Stuart, Florida DAVID MELTZER, Assistant Professor, Section of General Internal Medicine, Department of Economics, and Harris School of Public Policy Studies, University of Chicago JOSEPH E. MURRAY, Professor of Surgery, Emeritus, Harvard Medical School, Boston DOROTHY NELKIN, University Professor, New York University Department of Sociology and School of Law, New York MITCHELL W. SPELLMAN, Director of Academic Alliances and International Exchange Programs, Harvard Medical International, Harvard Medical School, Boston

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule IOM Project Staff ANDREW POPE, Director, Division of Health Sciences Policy CHRISTINE DOMZAL, Senior Program Officer (until 5/7/99) SARAH PITLUCK, Research Assistant ALDEN CHANG, Project Assistant GLEN SHAPIRO, Research Assistant (until 6/4/99) STEPHANIE SMITH, Research Associate (until 6/1/99) THELMA COX, Senior Project Assistant CARLOS GABRIEL, Financial Associate IOM Auxiliary Staff NICOLE AMADO, Project Assistant JENNIFER COHEN, Research Assistant JANE DURCH, Senior Editorial Associate MICHAEL EDINGTON, Managing Editor CHARLES EVANS, JR., Senior Advisor for Clinical and Biomedical Research SUSAN FOURT, Librarian FREDERICK J. MANNING, Senior Program Officer VIVIAN NOLAN, Research Associate PHILLIP RENZULLO, Staff Officer MELVIN H. WORTH, Jr., Scholar-in-Residence Consultant KATHI HANNA Copy Editors FLORENCE POILLON BETH GYORGY

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. In particular, reviewers were sought to provide a broad spectrum of views and a wide variety of positions on relevant transplantation issues. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the review of this report: NANCY L. ASCHER, School of Medicine, University of California at San Francisco J. STEVENSON BYNON, Division of Transplantation, University of Alabama at Birmingham CLIVE O. CALLENDER, Transplant Center, Howard University College of Medicine, Washington, D.C. ANTHONY M. D'ALESSANDRO, Department of Surgery, Medical School, University of Wisconsin, Madison CHARLES FISKE, National Transplant Action Committee, Brookline, Massachusetts RICHARD D. HASZ, JR., Transplant Coordinator Services, Gift of Life Donor Program, Philadelphia ROBERT S.D. HIGGINS, Thoracic Transplantation, Henry Ford Hospital, Detroit LARRY G. HUNSICKER, Department of Internal Medicine, College of Medicine, University of Iowa ALAN N. LANGNAS, Section of Transplantation, University of Nebraska Medical Center, Omaha ELAINE L. LARSON, Columbia University School of Nursing, New York BERNARD LO, Program in Medical Ethics, University of California at San Francisco JOSHUA MILLER, Division of Transplantation, University of Miami School of Medicine, Miami JAMES H. SOUTHARD, Department of Surgery, Medical School, University of Wisconsin, Madison HAROLD C. SOX, Jr., School of Medicine, Dartmouth University, Lebanon, New Hampshire MICHAEL A. STOTO, Department of Biostatistics and Epidemiology, George Washington University, Washington, D.C. CHARLES THOMAS, Samaritan Transplant Services, Phoenix

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule KENNETH E. THORPE, Department of Health Systems Management, Tulane University In addition to comments that the committee received from reviewers listed above, technical reviews of background material, and certain descriptive chapters, were also provided by representatives from Department of Health and Human Services and United Network for Organ Sharing. The committee also had access to and received input and technical assistance from transplant surgeons, experts on organ procurement, donor's families, and transplant recipients who served as expert liaisons. The 22 expert liaisons are listed in Appendix A. Although the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the Institute of Medicine.

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Foreword The procurement, allocation, and transplantation of human solid organs have undergone enormous change during the 15 years since enactment of the National Organ Transplant Act in 1984. The number and type of human organ transplants continue to increase rapidly. Although transplantation is increasingly effective and the quality of life of transplant recipients continues to improve, the total number of donor organs available falls significantly below the need for them. The resulting tension between supply and demand has raised many questions about organ procurement and transplantation policies. In the fall of 1998, Congress requested that the Institute of Medicine (IOM) conduct a study to evaluate the potential impact of pending regulations developed by the Department of Health and Human Services on a set of important specific issues related to organ procurement and transplantation. The study was conducted by a committee of recognized experts who volunteered their time to provide an objective scientific analysis of the issues and the available relevant data. In assembling the Committee on Organ Procurement and Transplantation Policy, the Institute cast a broad net, asking for suggestions from all relevant parties. The committee that was appointed, and who authored this report, includes experts representing many areas of science, health, economics, ethics, and patient concerns. The committee does not include any currently practicing solid organ transplant surgeons. This was done to avoid direct conflicts of interest and out of a concern that the strong viewpoints publicly expressed by many transplant surgeons might adversely affect the objectivity of the committee's deliberations. The committee did, however, have access to and receive input and technical assistance from transplant surgeons, experts on organ procurement, donor's families, and transplant patients. The committee conducted information-gathering sessions in two publicly announced open meetings. The organizations and individuals who made presentations are listed in Appendix A. In addition to these open meetings, the committee received a large amount of written material from a variety of sources,

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule and conducted original research and analyses on an extensive data base provided by the United Network for Organ Sharing. The committee carefully and thoroughly evaluated the information available in making its assessment, reaching conclusions, and developing recommendations. During the course of the study, one committee member elected to resign when he learned that the organization that employed him was considering a letter of intent for the Organ Procurement and Transplantation Network contract, thus creating the possibility of a perceived conflict of interest. As part of the normal process of developing an IOM report, an additional group of independent peer reviewers—who were not known to the committee during the report review process—then reviewed the committee's report to ensure that it met institutional standards for objectivity, evidence, and responsiveness to the study charge. This process involved review by individuals who had expressed strong opinions with regard to existing transplantation policies and procedures, as well as the pending Final Rule. The reviewers were selected to represent a broad range of quite different perspectives. The committee considered the reviewers' criticisms and suggestions in the course of finalizing its report as required by National Research Council procedures, but the report's conclusions and recommendations are solely those of the committee. The committee worked under an extraordinarily tight deadline to provide its report to Congress during the current legislative session. Nonetheless, the report is thorough, comprehensive, and thoughtful, and reflects the unanimous view of the committee. We are deeply grateful to this hard-working group of volunteers who completed a difficult and challenging task in a timely and effective manner. Kenneth I. Shine, M.D. President, Institute of Medicine

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Preface The system of solid organ transplantation in the United States involves a wide and complex network of participants, including donor families, surgeons, physicians, nurses, hospitals, transplant centers, organ procurement organizations, and federal agencies and contractors. These individuals and organizations strive to optimize the health and survival of patients who have received or are waiting for transplanted solid organs. Under ideal circumstances, there would be a suitable donor organ for every person who needs one. Despite the best efforts of all involved, however, the availability of organs falls significantly short of current demand. Moreover, despite the best-intentioned efforts of those involved, many patients find the system confusing and difficult to understand—leading, in some cases, to distrust of the very system designed to help them. In February 1999, the Institute of Medicine (IOM) formed the Committee on Organ Procurement and Transplantation Policy in response to a request from Congress to review proposed changes in the current system of organ procurement and transplantation. The so-called "Final Rule" of the Department of Health and Human Services would make several such changes as part of the stated purpose of achieving an organ allocation system that (a) functions as much as technologically feasible on a nationwide basis, (b) provides for effective oversight of the current network of operations, and (c) offers better information about transplantation to patients, families, and health care providers. The impetus behind parts of the Final Rule is a desire to correct apparent geographic disparities in the amount of time a given individual must wait for a transplant and to ensure that minorities and the economically disadvantaged receive equitable access to transplants. Evaluating the potential impact of the Final Rule on organ procurement and transplantation was a difficult task for many reasons. Among these is the fact that the Final Rule does not specify what the new organ allocation rules should

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule be, but instead establishes criteria and performance goals for the transplant community to meet through the development of appropriate policies. Conducting an evidence-based assessment was also difficult because of limitations both in the availability of data and, in some cases, in the data themselves. These data, the testimony provided to the committee, and the other information available to it, although quite voluminous in some areas, ranged in usefulness from helpful to contradictory or confusing. Moreover, as is often the case with complex data, its content and the way it is characterized by participants in the public discourse are often at odds. A large part of the committee's work focused on a review and analysis of approximately 68,000 liver transplant waiting list records that describe every change in status made by every patient on the Organ Procurement and Transplantation Network (OPTN) waiting list for liver transplants from 1995 through the first quarter of 1999. In addition, the committee held two public meetings and solicited additional input from a broad range of interested individuals and organizations. Based on its assessment of available data and other information, the committee finds that the current system is reasonably effective and equitable, but that it operates without effective supervision and oversight and could be more efficient in its allocation of livers to those with most urgent medical needs. Moreover, a lack of effective communication among the interested parties has polarized the discussions of various issues, such as those related to organ allocation, making them less productive than they could be and thus leaving significant room for improvement. In the end, the committee emerged from its deliberations generally supporting the concepts presented in the Final Rule—for example, broader sharing of organs and enhanced oversight—tempered by the practicalities of the transplantation process. The committee's recommendations, if implemented, could go a long way toward facilitating the development of improved principles of allocation and improving what everyone agrees should be a patient-centered system. The committee believes strongly that the federal government should provide effective oversight and review of the organ procurement and transplantation system, and that the system can be improved. This oversight and review should focus on assuring that the system is equitable, is grounded on sound medical sciences, and always places highest priority on the needs of the patients it serves. It is not the role of this oversight to micromanage day-to-day patient care. Government oversight should also ensure that information about the system is available to the research community and the public. Although the United Network for Organ Sharing (UNOS) currently collects, analyzes, and disseminates a great deal of information about the OPTN—more data than are available for most other medical procedures—many people feel that these data should be more timely and more broadly available, and that independent review and analysis would be of added value. In this regard, as the committee tried to work quickly in reaching its assessment, it was struck by the paucity of readily avail-

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule able public information and the apparent lack of accountability and peer review of the data system. To answer questions properly about the adequacy of the organ procurement and transplantation system, data collection and dissemination must be improved, and information must be made widely available to the public and the research community, while respecting the confidentiality and privacy of both donors and recipients. Finally, a perception of fairness is important to every aspect of this fragile system of procurement and transplantation. The system, therefore, not only has to be fair, but its fairness must be readily perceived by the public for many of the objectives to be accomplished, including increasing organ donations and improving minority access to transplantation. As the committee was putting final touches on the report, the governing board of the OPTN announced a change in its liver allocation rules, designed to increase the number of organs going to the patients in greatest medical need. The change seems to be an incremental improvement over the prior policy with respect to status 1 patients, but still leaves room for improvement. The short time frame of this study and the relative dearth of high-quality public information presented formidable challenges. The committee responded extremely well to these challenges and performed its task in a very professional manner. This would not have been possible without the help of many other people. I would especially like to thank the research staff at UNOS—Mary Ellison, Ann Harper, and Erick Edwards—who responded quickly and effectively to our numerous and complex data requests throughout the study. Their cooperation eased our task immeasurably. In addition, I would like to thank our colleagues at the General Accounting Office—Marcia Crosse, Roy Hogberg, and Donna Bulvin—who provided us with data on the costs of transplantation. Last, the staff who supported this activity are in large part responsible for both its quality and its timeliness. In this regard, I wish to acknowledge in particular the efforts of the IOM project staff—Andrew Pope, Kathi Hanna, Mike Edington, Sarah Pitluck, and Thelma Cox—as well as the staff of the National Academy Press, Sally Stanfield, Estelle Miller, Jim Gormley, Dawn Eichenlaub, and Ron Weeks. Without their tireless assistance, we would not have been able to complete this project in the time frame requested by Congress or to the standards required by the Institute of Medicine. Edward D. Penhoet, Ph.D. Chair

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Acronyms AHA American Hospital Association AIDS acquired immunodeficiency syndrome ALUs alternative local units CFR Code of Federal Regulations CT computerized tomography CTP Child-Turcotte-Pugh score DHHS Department of Health and Human Services ESRD end-stage renal disease FDA Food and Drug Administration GAO General Accounting Office HCC hepatocellular carcinoma HCFA Health Care Financing Administration HEHS Health Education and Human Services, GAO HIV human immunodeficiency virus ICU intensive care unit INR international normalized ratio IOM Institute of Medicine MIXNO mixed-effects nominal logistic regression MMLE maximum marginal likelihood estimates

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule MRI magnetic resonance imaging NHLBI National Heart, Lung, and Blood Institute, NIH NIH National Institutes of Health NMDP National Marrow Donor Program NOTA National Organ Transplant Act OAA Organ Allocation Area OPO Organ Procurement Organization OPTN Organ Procurement and Transplantation Network OTC ornithinine transcarbamylase deficiency TIPS transjugular intrahepatic portosystemic shunt placement TNM tumor-node-metastasis UNOS United Network for Organ Sharing USC United States Code

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Contents     ACRONYMS   xiii     LIST OF TABLES, FIGURES, AND BOXES   xvii     EXECUTIVE SUMMARY   1 1   INTRODUCTION   17     Evolution of the Federal System of Organ Transplantation   18     The Latest Call for Change: The ''Final Rule,"   23     The Ensuing Controversy   26     Charge to the Committee   27     Committee Methods and Focus of the Report   28     Organization of the Report   29 2   CURRENT POLICIES AND PRACTICES   31     Organ Procurement Organizations   32     The Organ Allocation Process   34     Criticisms of the Current Policies   38     Conclusions   38 3   ACCESS TO TRANSPLANTATION   39     Factors Affecting Access   41     Potential Closure of Small Transplant Centers   43     Potential Implications of Medicaid Payment Policies   45     Conclusions   46 4   ORGAN DONATION   49     Current Status   50

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule     Public and Professional Attitudes   52     Required Request and Routine Notification   56     Assessing OPO Performance   58     Conclusions   59 5   ANALYSIS OF WAITING TIMES   61     Method of Analysis   66     Results   68     The Effect of Sharing   82     Summary   86     Conclusions and Recommendations   87 6   ORGAN FAILURE AND PATIENT SURVIVAL   91     Organ Preservation and Donor Influences   92     Review of Literature   94     Assessing the Impact   94     Posttransplant Patient Survival   96     Conclusions   98 7   COSTS   123     Defining the Components of Cost   123     Increased Expenditures Due to Transplantation of Sicker Patients   127     Increased Expenses for Organ Acquisition   129     Conclusion   130 8   OVERSIGHT AND REVIEW   131     Role of the Federal Government   131     Data Collection, Analysis, and Dissemination   133     REFERENCES   137     APPENDIXES     A   Data Sources and Methods   145 B   Guide to Summary Tables   157 C   Current Liver Allocation Policies   183 D   The "Final Rule,"   199 E   Committee and Staff Biographies   215     INDEX   225

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule List of Tables, Figures, and Boxes TABLES ES-1   UNOS Liver Status for Patients 18 Years of Age According to Disease Severity,   4 ES-2   Summary of Literature on Cold Ischemic Times for Solid Organs,   13 1-1   Number of Transplants Performed in 1998,   18 1-2   UNOS National Patient Waiting List for Organ Transplants,   19 1-3   Number of Registrations on the National Transplant Waiting List by Organ at Year End, 1988-1998,   20 2-1   UNOS Liver Status for Patients ≥18 Years of Age According to Disease Severity,   37 4-1   Number of Cadaveric Donors by Donor Age from 1994 through October 31, 1998,   54 4-2   Number of Cadaveric Donors by Donor Race from 1994 through October 31, 1998,   55 5-1   Characteristics of Liver Transplant Patients by Status, 1995-1999,   62 5-2   Parameter Estimates (standard errors) for Likelihood of Liver Transplantation as a Function of Time, Age, Gender, Race, and OPO Volume: Individual Models for Statuses 1, 2B, and 3 for All Available Data in 1998-1999,   70 5-3   Parameter Estimates (standard errors) for Likelihood of Pretransplant Mortality as a Function of Time, Age, Gender, Race, and OPO Volume: Individual Models for Statuses 1, 2B, and 3 for All Available Data in 1998-1999,   71

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 5-4   Parameter Estimates (standard errors) for Likelihood of Liver Transplantation as a Function of Time, and Linear and Nonlinear Effects of OPO Size (in millions): Individual Models for Statuses 1, 2B, and 3 for All Available Data in 1998-1999,   79 5-5   Parameter Estimates (standard errors) for Likelihood of Pretransplantation Mortality as a Function of Time, and Linear and Nonlinear Effects of OPO Size (in millions): Individual Models for Statuses 1, 2B, and 3 for All Available Data in 1998-1999,   79 6-1   Summary of Literature on Cold Ischemic Times for Solid Organs,   94 6-2   Heart: Summary of Literature on Cold Ischemic Times,   100 6-3   Kidney: Summary of Literature on Cold Ischemic Times,   102 6-4   Liver: Summary of Literature on Cold Ischemic Times,   106 6-5   Lung: Summary of Literature on Cold Ischemic Times,   118 6-6   Pancreas: Summary of Literature on Cold Ischemic Times,   120 7-1   Economic Concepts in Health Care,   124 7-2   Estimated Billed Charges ($1,000s) for Organ Transplants, 1996,   125 7-3   Average Billed Charges (1996 Dollars) per Transplantation, First Year After Transplantation,   126 7-4   Information on Medicare-Covered Liver Transplant Recipients, Calendar Year 1995 through 1998,   127 B-1   Transplants, Mortality, Waiting Time, and Demographics by OPO Patients During Status 1, Sorted by OPO Volume, 1995-1999,   160 B-2   Transplants, Mortality, Waiting Time, and Demographics by OPO Patients During Status 1, Sorted by OPO Volume-Adults Only (18 and over), 1995-1999,   162 B-3   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 1: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   164 B-4   Transplants, Mortality, Waiting Time, and Demographics by OPO Patients During Status 2, Sorted by OPO Volume, 1995-1999,   166 B-5   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 2B: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   168 B-6   Transplants, Mortality, Waiting Time, and Demographics by OPO Patients During Status 3 or 4, Sorted by OPO Volume, 1995-1999,   170 B-7   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 3: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   172 B-8   Status of Transplanted Patients by OPO, Percentages (1995-1999),   173 B-9   Initial Listing Status by OPO, Percentages (1995-1999),   174

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule B-10   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 1 as a Function of OPO Size: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   175 B-11   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 2B as a Function of OPO Size: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   175 B-12   Mixed-Effects Competing Risk Survival Model for Patient Time in Status 3 as a Function of OPO Size: Maximum Marginal Likelihood Estimates (MMLE), 1998-1999,   176 B-13   Ratios of Transplants to Listings by OPO Sorted by Number of Transplants; Ratios Expressed as a Percentage, 1995-1999,   178 B-14   Number of Transplants (overall and by status) and Number of Listings per Million People Served Sorted by Number of Transplants, 1995-1999,   180 C-1   Child-Turcotte-Pugh (CTP) Scoring Systems to Assess Severity of Liver Disease,   191 C-2   American Liver Tumor Study Group Modified Tumor-Node-Metastasis (TNM) Staging Classification (1),   196 FIGURES ES-1   A three-dimensional view of the relationships among waiting-list time (measured in months), OPO population (in millions), and probability of transplant (a) and death (b) for status 2B patients,   8 ES-2   A three-dimensional view of the relationships among waiting-list time (measured in months), OPO population (in millions), and probability of transplant (a) and death (b) for status 3 patients,   9 1-1   Organ Procurement Organization service areas, 1997,   21 5-1   Median waiting times for liver transplantation, all status groups. Panel 1: All patients; panel 2: patients ever in status 1; panel 3: patients ever in status 2A; panel 4: patients ever in status 2B; and panel 5: patients ever in status 3,   63 5-2   Estimated daily hazard rates (a) and cumulative time-event distribution (b) for status 1 patients awaiting liver transplantation,   73 5-3   Estimated monthly hazard rates (a) and cumulative time-event distribution (b) for status 2B patients awaiting liver transplantation,   75 5-4   Estimated monthly hazard rates (a) and cumulative time-event distribution (b) for status 3 patients awaiting liver transplantation,   77 5-5   A three-dimensional view of the relationships among waiting-list time (measured in days), OPO population (in millions), and probability of transplant (a) and death (b) for status 1 patients,   80

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule 5-6   A three-dimensional view of the relationships among waiting-list time (measured in months), OPO population (in millions), and probability of transplant (a) and death (b) for status 2B patients,   83 5-7   A three-dimensional view of the relationships among waiting-list time (measured in months), OPO population (in millions), and probability of transplant (a) and death (b) for status 3 patients,   84 BOXES 2-1   Definitions,   32 4-1   Excerpt from the 1998 Gallup Poll on Organ Donation,   52 6-1   National Marrow Donor Program,   97 A-1   Expert Liaisons,   146 A-2   Organizations and Individuals Appearing Before the Committee,   147 C-1   Amended UNOS Policy 3.6-Allocation of Livers,   185

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Organ Procurement and Transplantation

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