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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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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