Enhancing Access to Organ Transplantation — and Why a Technological Leap is Necessary
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In the recently Social Impact Review published article, "The Long Haul: Engineering High-Tech Solutions to the Organ Shortage,” Mary Sauer details the fascinating efforts underway to use stem-cell science, 3D bioprinting and other technologies to produce organs for transplantation. Headlines in recent months have detailed attempts to use genetically-modified animal organs for humans needing an organ transplant.
These scientific and technological advances are inching forward while the various stakeholders in the organ transplant ecosystem strenuously debate policies that might result in a more successful, equitable and efficient organ transplant system in the U.S. While the debate is important, it is unlikely to result in any policy initiatives that will make a serious dent in the current waiting lists for transplantation. Even with the best policies in place, it is very hard to imagine a world in which an organ exists for every person who needs one — at least until the day (as described in Mary Sauer’s piece) when a physician can “pick the organ from the shelf and save this person’s life.”
The scope of the problem
As of mid-January, the organ transplant waiting list included 104,736 Americans, a total that substantially understates the actual transplant need, given well documented disparities in accessing the waiting list, based on race, ethnicity, gender, geography, socioeconomics, disability and immigration status. Not all of the 558,000 patients undergoing dialysis are candidates for transplant but the fact that only about 16.3% of them (or 91,099) are on the list for a kidney transplant is telling and very troubling.
The total waiting list at any given time also masks its constant reformulation: 17 people on the list die each day waiting for an organ that never came. They are, in turn, replaced by the one new person added to the list every nine minutes. In addition to the 5,758 people who died on the waiting list in 2021, another 5,371 were removed from the list because their condition deteriorated, rendering them too sick to receive a transplant.
Moreover, these statistics cannot begin to describe the distress that people like Mary Sauer experienced while waiting for an organ for a loved one, not knowing from one day to the next whether that gift of life might arrive in time. The fact that the one millionth U.S. transplant occurred on September 9, 2022, or that in 2021, during the height of the COVID pandemic, a record number of organ transplants (41,354) were performed, offers little solace.
All stakeholders within the transplant ecosystem agree that we must do better, but that may be where the consensus ends. A heated debate is underway over what needs to be done to improve organ transplantation — which has led some to reconsider some of the basic principles of the current organ donation system.
The context
The current organ transplant process is substantially governed by a 1984 federal law, the National Organ Transplant Act (NOTA), and by the 1968 Uniform Anatomical Gift Act (UAGA), adopted in largely the same form by all 50 states. While both statutes have been revised, it is remarkable that the same basic legal constructs continue to govern organ transplantation despite the considerable scientific and medical advances in the field that have occurred since they were enacted.
NOTA principally accomplished two things: it prohibited compensating people for the donation of their organs and it authorized the “outsourcing” of the Organ Procurement and Transplantation Network (OPTN) to a non-profit organization. The UAGA’s core principles include reliance upon the authorization by the decedent or family members of organ donors and the requirement that the donor be determined to be dead.
Each of these four main tenets from the laws that govern the current system have been cited as impediments to meeting the goal of providing an organ transplant to anyone who needs one.
The compensation conundrum
NOTA’s ban on compensation for organs was an entirely justified response to efforts underway in the early 1980s to purchase and sell organs from people in poor third world countries to meet the organ demand in the U.S. While allowing an unfettered market for the sale of organs from living or deceased donors has not been seriously advanced, advocates have focused on whether a total compensation ban should be reexamined.
A 2015 cost-benefit analysis concluded that paying living donors $45,000 and deceased donors $10,000 per kidney would effectively end the kidney transplant shortage and actually save taxpayers $12 billion per year by reducing dialysis and other expenses. Short of that proposal, transplant policy experts have urged more modest relaxations of anti-compensation rules to encourage organ donation. Pending legislation includes the Living Donor Protection Act, which would explicitly protect living donors from discrimination in accessing life, disability or long-term care insurance and would extend the Family and Medical Leave Act to cover living organ donors. In 2020, the Department of Health and Human Services promulgated new regulations that expanded reimbursement for travel and living expenses for living donors and extended reimbursement to cover lost wages and family expenses.
The role of UNOS
NOTA envisioned an Organ Procurement and Transplant Network (OPTN) that would be overseen by a nonprofit entity pursuant to a contract with the federal government. The United Network of Organ Sharing (UNOS) has held that contract since 1986. Recently, its performance has been widely criticized, including by a bipartisan Senate Finance Committee investigation that recently concluded that UNOS is not adequately overseeing the performance of the nation’s 57 Organ Procurement Organizations, that patient safety has been compromised by testing errors and organ shipping failures and that UNOS lacks the necessary expertise to operate its information technology system, causing additional patient risks.
Senator Elizabeth Warren’s statement to the UNOS CEO at the hearing was even more critical: “You should lose this contract. You should not be allowed anywhere near the organ transplant system in this country.”
Given these findings, NOTA’s reliance on any non-public entity to operate the OPTN may be worth reconsidering. At a minimum, selecting a new contractor in 2023 when the current contract expires, enhancing the oversight of the cybersecurity of the OPTN and dividing up the OPTN contract into separate policy and technology roles have all been recommended.
“Opt-in” vs. “opt-out” donor registration
The UAGA put in place an organ donation construct premised on gift law, allowing donors to register their intention to donate — or “opt-in”— in advance of death (e.g., through an organ donor registry) or for family members or other surrogates to agree to donate on the decedent’s behalf. Other nations, including Spain, Austria, Belgium and, more recently, the United Kingdom, presume that a deceased person is a willing donor unless he or she has indicated otherwise — or “opted out” from organ donation.
Proposals have been advanced in many states to adopt an “opt-out” approach to organ donation, but none have been enacted. The notion of “presumed consent” may be at odds with the libertarian strain in the U.S. that rebels at mask and vaccine mandates. In addition, advocates for the current “opt-in” construct persuasively contend that it preserves two pathways to organ donation—either through donor registration or with the consent of surrogates— whereas “opt-out” countries proceed with donation only if family members do not object. In other words, before a donation takes place under the “presumed consent” or “opt-out” approach, family members or other surrogates must agree. By contrast, under the American “opt-in” approach, a donation is fully authorized by the deceased and, while the family members will be consulted, no further consent is necessary – and, if the potential donor hasn’t opted in, the organ procurement agency can still approach the family members to seek their approval for the donation.
The “dead donor” rule
Perhaps the most important — and sacrosanct — element of the UAGA is the so-called “dead donor rule,” which requires that patients be declared dead before any organs are removed for transplantation. The definition of death generally requires the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all brain functions.
More recently, controlled donations after circulatory death — or cDCD — have been seen as a promising approach to increase organ supply. While cDCD donations have taken place internationally, the process has been rarely employed in the U.S. due to ethical and legal concerns. In cDCD, when a patient is determined to be unable to survive or improve, a family (or the patient through an advanced directive) may elect to discontinue further medical care. After life support is discontinued and the heart stops beating, the patient is declared dead. In cDCD, after a few minutes, circulation is restored to facilitate the recovery of organs, including the heart — a step that may not be easily reconciled with the concept of “irreversible cessation” of circulatory function.
The potential results
If the above policy changes were implemented, more organs would presumably be recovered and transplanted. But not nearly enough.
One advocate for replacing UNOS estimated that the system could “get five percent better, which would be thousands of transplants.” If increased financial incentives were provided to encourage organ donation, it is reasonable to assume that additional organs would be donated. While it is unlikely that any substantial increase in organ donation would occur if “opt-out” became the norm in the U.S., the use of cDCD protocols has been estimated to expand the heart donor pool by as much as 20 percent.
Even if all of these dramatic policy changes were made, tens of thousands of Americans would remain on the organ donation waiting list indefinitely.
The debate over the existing policies should continue and even the most ingrained elements of the organ donation system in the U.S. deserve serious re-examination and reform. Any realistic hope for a significant reduction of the organ waiting list will, however, await the tantalizing technological advances that may be in the offing in the decades ahead. The sooner we can achieve these technological advances, more lives will be saved and fewer people will die waiting for an organ.
About the Author:
James W. Lytle was, until his retirement earlier this year, a Partner and then Senior Counsel in the Albany and Boston offices of Manatt, Phelps & Phillips LLP, a national law and consulting firm. He provided health law and governmental relations representation to a broad array of clients with interests before the New York State Legislature, the executive branch, and the courts. His clients have been leaders in the fields of health and higher education, cultural affairs, human services, and biomedical research. He has been recognized by Chambers USA as a Leading Lawyer since 2011 and was included in Best Lawyers in America since 2013, where he was named Best Lawyer of the Year in Albany for Health Law in 2017 and for Government Relations Law in 2017 and 2020. Between 2020 and 2021, he was a Fellow with the Advanced Leadership Initiative at Harvard University and an adjunct professor at New York University Law School. Earlier in his career, he served as Assistant Counsel for Health and Human Services for Governor Mario M. Cuomo, was the founding director of the Volunteer Legal Services Project in Rochester, N.Y. and began his legal career as an Assistant District Attorney in Manhattan. He graduated from Princeton University in 1974 and received his JD from Harvard Law School in 1978, where he was the Director of the Harvard Legislative Research Bureau. He is a former Chair of the Health Law Section of the New York State Bar Association and serves on the boards of the Schuyler Center for Analysis and Advocacy, FAIRHealth, the Mental Health Association of New York State, and Donate Life New York State and is on the advisory boards to Petrie-Flom Center at Harvard Law School and the Transplant Institute at NYU Langone.