Female hand writing signature on the paper document.

How to Construct Better Organ Donation Policy and Achieve Health Equity

By James R. Jolin

The United States is facing an organ donation crisis, with massive gaps between supply and demand.

Per estimates from the Department of Health and Human Services (HHS), over 106,000 Americans are currently awaiting this life-saving medical treatment. Further, the burden of this shortage falls unequally:  in 2020, while approximately 48% of white patients in need of transplants received an organ, only 27% of Black patients secured one.

The stakes are too high to allow the organ donation crisis to proceed in the U.S. without bold intervention. But with many policy options on the table, unresolved ethical concerns, and a patchwork of organ donation laws across the country, the proper path forward is not immediately clear.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Recent Organ Procurement Organization Regulations Will Save Lives

By Matthew Wadsworth

Thirty-three Americans die every day for lack of an organ transplant. As the CEO of an organ procurement organization (OPO) — one of the network of 57 government contractors responsible for organ recovery across the country — this is what I think about every day: how to help the 3,000 people waiting in my home state of Ohio and the more than 100,000 others around the country who wake up each morning hoping they get a call that a transplant is available.

Fortunately, the U.S Department of Health and Human Services (HHS) recently published new, pro-patient regulations to bring baseline accountability to OPOs. While some of my peers have opposed the reform effort, I see it as long overdue.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

How to Encourage Organ Donation

By James W. Lytle

Last week, Bill of Health published a Q&A with Phil Walton, the Project Lead for Deemed Consent Legislation with the National Health Service Blood and Transplant Division, and Alexandra Glazier, the President/CEO of the New England Donor Services.

In the first part of this conversation, Walton and Glazier described the various frameworks undergirding organ donor registries in their home countries. Walton detailed the “deemed consent” or “opt-out” registry employed by Wales and England, while Glazier detailed the opt-in, prompted choice framework in the U.S.

In this second installment, Walton and Glazier discuss strategies to encourage organ donation, regardless of the opt-in or opt-out framework. The conversation also touched on health disparities and strategies to address them.

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adult and child hands holding red heart, organ donation concept image.

Opt-in vs. Opt-out Organ Donation Schemes: Evidence from the US and UK

By James W. Lytle

We need to encourage organ donation. In the U.S. alone, even with a record number of about 40,000 transplants in 2019 and some progress made towards closing the gap, approximately 108,000 Americans are on the waiting list.

In considering the best way to increase organ donation, much of the debate has focused on how to make organ donor registries more successful: nothing facilitates the prospect for organ donation more than knowing that a potential donor has already indicated their intention to donate.

Should registries, like those in the U.S., require people to elect to join (the “opt-in” approach) or should they presume consent to organ donation and register everyone except those who explicitly “opt-out,” as is the case in certain other countries?

I asked two transplant professionals, one from the U.S. and one from Wales, to help consider this question and related issues involving organ donation.

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organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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Adult and child holding kidney shaped paper on textured blue background.

New Regulation Aims at Accountability for Organ Procurement Organizations

By James W. Lytle and Abe Sutton

Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.

While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.

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Adult and child holding kidney shaped paper on textured blue background.

Nudging Organ Donation in the United States

Cross-posted from Harvard Law Today, where it originally appeared on November 13, 2020. 

By Chloe Reichel

Nationally and globally, demand for organ transplants outstrips supply. In the United States last year, 19,267 donors made a record-setting 39,718 transplants possible, but nearly 109,000 Americans still remain on the organ transplant waiting list.

Cass Sunstein ’78, Robert Walmsley University Professor and former Administrator of the White House Office of Information and Regulatory Affairs in the Obama administration, believes “Nudge theory” might help bridge this gap between supply and demand.

Sunstein joined scholars and leaders in transplant services on Friday, Nov. 6 to discuss strategies to boost rates of organ donation at “Nudging Organ Donation: Tools to Encourage Organ Availability,” an event hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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bloody zombie hands grasping air

Considerations for a Zombie Apocalypse: The Definition of Death Among the “Walking Dead”

While there has been a great deal in the literature that discusses the ethics of neurologic, cardiopulmonary and biologic death in the context of organ donation, there has been very little attention to this application with regard to zombies. Zombies are often referred to as “living-dead” which creates both a scientific, operational, and ethical conundrum with regard to classification. To date, there is no definitive answer as to whether zombies are truly “dead” or whether they are “living” or that they exist along the spectrum of conscious to coma, from living to dead. In the event of a zombie apocalypse, it is currently unclear whether or not zombies could be considered suitable organ donors.

Zombies: A Definition and Brief History

Zombies are a class of “living dead” that also includes vampires, ghouls, mummies, and wights. The term “zombi” was reportedly first used by the poet Robert Southey in his description of Brazilian history. One of the earliest references to zombies dates back to Mesopotamia in the Descent of Ishtar when the goddess Ishtar threatens to “raise up the dead, and they shall eat the living.”

Since then, there have been hundreds, if not thousands, of descriptions of undead, zombies, and reanimated humans in comics, books, television programs, and movies. Some cultures have an extensive history of zombies, the most well-described and studied being the Haitian Zombies of Voodoo.

Zombies are further divided into subcategories: zombies reanimated by black magic (Voodoo), those created by sorcery (necromantic), viral- induced (Solanum) and those created by mutation from radiation (atomic). There have been case reports of drug-induced zombies, but these were later re-classified as this state was reversible without intervention. There is a movement to utilize the more descriptive terminology Ataxic Neurodegenerative Satiety Deficiency Disorder (ANSDS).

Culturally, the term differently-animated has been used as a more politically correct term for identifying zombies. The varied terms, means by which zombification can occur and the newer, more descriptive and politically correct terminology however, has done little in the way to describe the actual physiologic state of zombies. This requires a more in-depth analysis of what we do and do not know about zombie biologic and specifically neurologic function.

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Rethinking Organ Donation: When Altruism Isn’t Enough

By: Gali Katznelson

The demand for donated organs greatly outweighs the supply. In the United States alone, there are roughly 115,000 people waiting for an organ transplant. Every ten minutes, a new person is added to the recipient list, and every day, 20 people on the list die waiting. To be an organ donor in most states, residents can choose to add their names to the donor registry through a simple online or in-person process. But this “opt-in” system is failing to entice enough people to become organ donors. Currently, 54% of Americans are on the donor registry, but very few registrants are available to donate at a given time, in large part because the vast majority of registered donors have opted to do so posthumously. Better policies are needed to encourage more people to donate, both as living donors and as registered posthumous donors. It’s time to consider a non-monetary incentive system that prioritizes those who have signed up as organ donors.

Before jumping into an incentive-based system, let’s consider other options: namely “opt-out” and “mandated choice.” Following in the footsteps of 25 countries, including Spain and Wales, states such as Connecticut and Texas have made attempts to implement “opt-out” policies. In an “opt-out” system, each person is presumed to be an organ donor unless they explicitly choose not to be. Countries with opt-out policies have donor registration rates averaging 90%. But attempts to pass such legislation in the US have been met with fierce opposition. Likely, this is due to Americans’ unique emphasis on individual rights and skepticism of government control. Moreover, in such a system, family members may question the wishes of the deceased if they are unsure that the person was aware of the policy. In such cases, the family’s wishes will likely override the seemingly ambiguous wish of the deceased.

Alternatively, a “mandated choice” system is one in which people are faced with a compulsory choice regarding organ donation. In the US, Texas first tried this in the 1990s, where checking “yes” or “no” to organ donation became a condition for obtaining a driver’s license. Without adequate public education, 80% of people chose not to donate and the law was eventually repealed. More recently, Illinois experienced success with a mandated choice system. There, anyone receiving or renewing a driver’s license or an identification card is faced with the choice of becoming an organ donor. As a result, 60% of adults have now agreed to donate. This is a good start, but we can do better.

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Chimeras with benefits? Transplants from bioengineered human/pig donors

By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Read More