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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Scientist analyzes DNA gel used in genetics, forensics, drug discovery, biology and medicine

Transplant Genomics: Ethical, Legal, and Social Implications

By Tamar Schiff

The appeal of precision medicine is of particular significance in transplantation. Treatment options are already integrally dependent on genetic factors – the donor-recipient match – and the demand for transplantable tissues far outstrips the available supply.

And the potential is only growing. Advances in genetic and genomic studies have identified an increasing number of novel biomarkers of potential use in transplant-related care. These include predictors of disease course, graft survival, response to immunosuppression, and likelihood of disease recurrence or other complications.

With wider availability of sequencing technologies and innovations in databanking, future clinical applications in transplant care may require ever-growing considerations of the significance of genetic variants, fair access to precision medicine therapeutics and participation in research, ethical approaches to data aggregation, and social determinants of health.

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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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State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant
Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

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