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.

The need for reform

Having helped lead OPO turnarounds in Nevada and Dayton, Ohio, I feel a duty of care to explain why patients across the country need these reforms. The proposed reforms would impose new measures for evaluating OPO performance and make the recertification of OPOs contingent on performance within the top quartile.

HHS estimates these reforms will save more than 7,000 additional lives every year, as well as $1 billion annually to Medicare through avoided dialysis costs resulting from increased kidney transplants. I actually think the opportunity is even larger than that.

Because COVID-19 increases the risk of organ failure, these reforms are also now more urgent than ever. And as the House Committee on Oversight and Reform correctly noted, “the burden of OPO failures is disproportionately borne by patients of color, making OPO reform an urgent health care equity issue.”

Some have tried to deflect criticism of the OPO system by invoking recent growth in organ donation as evidence of the system’s success. But peer-reviewed research finds that this growth is due not to the success of the system, but rather to excess deaths arising from the nation’s drug epidemic: “it is indisputable that nationally the increased number of donors is almost wholly attributable to the drug epidemic, and reflects the byproduct of a national tragedy, rather than an improved system to be celebrated.”

After controlling for increases in donation owing to the opioid epidemic, as well as transplant center advancements which have increased the absolute size of the donor pool, over the last nine years it turns out OPOs have not even kept pace with simple population growth. Rather than advancing, the OPO industry, on net, has been regressing. Patients deserve better.

Ironically, the biggest driver of OPO improvement actually seems to have been the OPO accountability reforms themselves.

“Since the [2019] executive order announcing the proposed new metrics and increased oversight, data show that OPO performance has already begun to improve, perhaps early evidence of the “Hawthorne effect” (i.e., increased scrutiny and observation by itself drives behavior change that leads to improved outcomes),” new research supported by Schmidt Futures and Arnold Ventures finds. “That such gains were possible, and yet unmade prior to the executive order, underscores the importance for HHS to institutionalize such regulatory pressure for OPOs to improve performance.”

Reaction to the regulation

Every major patient group engaged on this issue — including the Global Liver Institute, National Kidney Foundation, American Society of Nephrology, the Boomer Esiason Foundation, Organize, and families directly affected by the organ shortage, as well as advocacy groups ranging from Families USA to FreedomWorks — have universally supported HHS’s new OPO metrics.

Additionally, they have been advocated for by as diverse an expert group as any public health initiative in recent memory, including: the organ donation leads for both the past two White Houses; a Nobel Prize winning economist; the former Chief Data Scientist of the United States under President Obama; policy leaders varying from the former Acting Administrator of the Centers for Medicare and Medicaid Services for President Obama to the Executive Director of the Senate Conservatives Fund; leading national philanthropies including Schmidt Futures and Arnold Ventures; all five (bipartisan) former Chief Technology Officers of the US Department of Health and Human Services; the former President of the NAACP; and a broad, bipartisan swath of Congressional representatives.

Context on OPOs

OPOs are the only major program in all of healthcare that are 100% reimbursed for all costs, even those unrelated to patient care. Some OPOs, to be sure, operate with the utmost integrity, but others have abused the public trust; audits from the Office of the Inspector General have documented fraud, waste and abuse at some OPOs, and two OPO executives were even sentenced to Federal prison for participation in a kickback scheme with a local funeral home to defraud taxpayers. OPOs are often touted as community-based non-profits, but we’re also a $3 billion industry.

As two of my colleagues in positions of industry leadership positions have written: “OPOs operate as geographic monopolies, which means we have neither regulatory nor competitive pressure to provide high service to patients. And while there may be legitimate reasons for at least some monopolism (e.g., potential donor families should not have two OPOs competing for their attention), the trade-off must be increased transparency and oversight.”

The New York Times editorial board agreed, writing: “an astounding lack of accountability and oversight in the nation’s creaking, monopolistic organ transplant system is allowing hundreds of thousands of potential organ donations to fall through the cracks,” and calling on HHS to implement reforms “quickly and thoroughly.”

Conclusion

As a network of government monopoly contractors managing $3 billion taxpayer dollars annually, objective evaluation of performance seems to the very bare minimum patients and government should expect in return. HHS’s OPO reforms will help 7,000 more patients receive lifesaving transplant every year, as well as help address a major healthcare inequity. The Biden-Harris Administration should enforce these reforms as urgently as possible, building on important work begun four years ago in the Obama-Biden Administration.

 

Matthew Wadsworth is the CEO of LifeConnection of Ohio, the OPO covering Northwest and West Central Ohio. Since Matt took over as CEO on January 1, 2020, the OPO has increased donation rates by 36%.

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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