Organ donations save lives — that is, if livers, kidneys, pancreases, and other organs get to the patients who need them in time. But an eye-opening Senate investigation in 2022 found that 28,000 more organs could be transplanted in the United States annually if the system were better run.
Think about that — 28,000 potential lives saved.
The Senate’s report, and many other recent inquiries, cast a harsh spotlight on America’s fragmented system for matching transplanted organs from deceased donors with waiting patients and amplified calls for reform.
Ongoing efforts to bring accountability to the system are moving in the right direction.
But now questions have emerged over whether the method used to judge whether organ transplant organizations are improving enough is fair. Federal regulators should be careful not to let the pendulum swing too far. As they adopt a new accountability system, they need to ensure they are doing it in a way that is reasonable — that eliminates the worst-performing organizations, gives mediocre ones a path to improve, and doesn’t cause undue disruption in the organ transplant system.
There is little question that reforms are overdue. There are more than 103,000 people currently waiting for organs, including more than 4,100 in Massachusetts, according to the Organ Procurement and Transplantation Network, which oversees the transplant system. In 2023, 5,362 people nationwide died on the waiting list.
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Transplants have historically been organized by a patchwork of regional nonprofits that collect organs and transport them to patients who need them.
The Washington Post reports that the US Department of Justice is investigating several of those organ procurement organizations over allegations of fraud, kickbacks, and improper billing practices.
In 2020, the US Senate Finance Committee investigated alleged lapses in patient safety in the organ transplant system and looked into the large numbers of organs going unused.
The US House Committee on Energy and Commerce is investigating problems with OPTN’s management of the organ donor system; the House Committee on Oversight and Accountability is investigating allegations of poor performance, waste, and mismanagement in the industry; and the Inspector General is investigating whether OPOs comply with Medicare billing requirements.
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While the system has been riddled with problems, reforms are ongoing. In 2020, the Centers for Medicare and Medicaid Services finalized a rule based on a Donald Trump-era policy establishing performance standards for OPOs, which will result in underperforming OPOs being decertified — which means they can no longer participate in the transplant system — in 2026.
A bill President Biden signed in 2023, which this board supported, will break OPTN into multiple contracts in an attempt to increase competition and quality. The government is currently soliciting bids for these new contracts.
Having an accountability metric measuring OPO performance is vital. Failing OPOs should face decertification, and their region should be transferred to a better-performing OPO.
At the same time, the system is complex, and crafting an accountability metric is challenging.
As the federal government implements these changes, the Department of Health and Human Services must ensure the metrics being used to measure performance are the right ones and the policies are being implemented in a way that improves quality. There are lingering questions about whether the system is fair, and CMS should ensure these questions are answered and the metric is appropriate.
All 14 transplant centers in New England wrote to HHS last year expressing concerns that the metric being used to measure performance is “significantly flawed.” Officials with New England Donor Services, New England’s OPO, raised similar concerns in a meeting with the Globe editorial board.
The new metric measures every OPO’s donation rate and transplant rate — how many potential donors give an organ and how many available organs go to patients. A performance standard is set based on all OPOs’ median performance. Any organization where either rate falls below the prior year’s median (with a confidence interval that gives organizations some buffer) is considered “tier 3.” Any organization in that tier in 2024 will lose their certification in 2026. Organizations that are above the median but below the top 25 percentile in one or both measures will have to compete to keep their contracts.
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The median donation and transplant rates have been rising. That’s a good thing because it means the organizations have been improving their performance, likely in response to the new accountability measures. But the rising bar also makes it harder for OPOs to meet the standard.
According to the Centers for Medicare and Medicaid Services, there were 16 organizations in the lowest tier in 2021, 22 organizations in 2022, and 24 organizations in 2023. There are currently 56 total OPOs.
These organizations undoubtedly have areas they can and should improve on. But the transplant hospitals and OPOs raise legitimate questions about whether decertification is warranted for such a large swath of organizations — or whether there might be room to help organizations near the median improve while reserving decertification for organizations that are statistical outliers.
As New England Donor Services CEO Alexandra Glazier put it, the system should incentivize improvement, but “you don’t want to burn the house down.”
The provider, which currently ranks in the middle tier, is also raising questions around whether the decertification measure is biased against large organizations. Researchers at the Scientific Registry of Transplant Recipients, which provides statistical and research analysis of transplant data, prepared abstracts to be presented at a recent American Transplant Congress meeting arguing that the statistical methodology is biased against large OPOs and suggesting changes. A SRTR spokesperson said the US Health Resources and Services Administration withdrew approval of the abstracts “citing concerns about HRSA seen as being critical of CMS’ oversight of organ procurement organizations.” The preliminary research is not peer-reviewed, and other statisticians and researchers told the editorial board that the formula is not biased. Regulators should review the available data and be open to adapting the formula if bias is an issue.
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The rule was adopted after extensive public input. But now that it is being implemented and the real-life applications are becoming clearer, CMS should continue to take all concerns into account to ensure the measure is doing what it is intended to do — provide fair, transparent accountability for the performance of organ procurement organizations, weed out the worst-performing organizations, and promote improvement in an industry that for thousands of Americans is a matter of life or death.
Editorials represent the views of the Boston Globe Editorial Board. Follow us @GlobeOpinion.
