Last December, the Department of Health and Human Services proposed new regulations to reform the U.S. organ donation system. It would accomplish this by creating objective criteria by which to evaluate the government contractors, called organ procurement organizations, who are charged with recovering transplantable, lifesaving organs from deceased donors. These bipartisan reforms could save countless lives. It’s important the Trump administration finalize them now.
As CEOs of two OPOs, this is an issue we have followed closely, and we applaud these measures as long overdue.
Our constituents are the more than 100,000 Americans currently waiting for a lifesaving transplant, with 33 dying every day for lack of an organ. Given that COVID-19 can cause organ failure, reform is even more urgent today than it was a year ago. HHS estimates that its proposal will mean an estimated 5,000 to 10,000 more life-saving organ transplants every year.
Central to the problem is that, historically, the government has not used objective criteria to evaluate OPO performance. OPOs are allowed to self-interpret and self-report our own performance data. As a result, no OPO has ever lost its government contract, even as wildly variable performance across OPOs has led to unnecessary deaths for patients in need of transplants.
Compounding the problem is that all 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.
HHS’s proposal, rightly, promises to implement much-needed accountability measures, with real consequence for our counterparts that fail to meet them — including replacing OPOs who simply do not get the job done. In response, many OPOs have responded with aggressive lobbying campaigns to block these proposed reforms by confusing the issue or proposing unworkable alternatives.
But the more future-minded OPOs, like ours, are embracing change. HHS’s new proposal signals something potentially game-changing for patients: allowing the highest performing OPOs to replace those who have proven themselves incapable of serving their communities. To the extent that an OPO is not able to rise to the challenge of a high standard, the focus of our attention and energy must be on better serving patients on the national waitlist, not on protecting specific OPOs.
This, of course, is threatening for OPOs who have grown a bit too comfortable. Some of our colleagues have tried to paint any changes as destabilizing and unprecedented, positing that it will lead to situations in which areas of the country do not have OPOs at all. But this is simply not grounded in HHS’s proposal, which explicitly states that “our goal is to ensure continuous coverage of an OPO service area in the event an OPO is decertified.”
There were originally 128 OPOs, and after decades of consolidations there are now 58 OPOs; never has this process been disruptive. Forcing OPOs to continually earn their contracts is a patient-centric accountability mechanism, ensuring that OPOs operate with the urgency befitting the life-and-death consequences of this work.
Additionally, many OPOs have argued that the standard for OPO performance HHS has proposed is “arbitrary.” But the more important question is whether the improvements HHS seeks to drive are realistically achievable, and we believe unequivocally that they are; HHS data show the difference between the best and worst OPOs is almost 500 percent. Put another way, some OPOs recover 4 or 5 times as many organs as their peers.
So if we accept that higher performance is possible — and we understand that it would also be lifesaving — realizing these gains is not simply a policy question, but a social imperative. As patient advocates have argued, and with which we whole-heartedly agree, “In a chronically underperforming system, patients should fear a perpetuation of the status quo, not a disruption of it.”
It’s time that HHS unleashed the best weapon it has against the life-threatening organ shortage: OPOs who have already proven themselves motivated and capable. HHS should finalize its proposal as urgently as possible, trusting the best among us to rise to that challenge. Any weakening of HHS’s proposed standard will — definitionally — result in lives lost, which is directly antithetical to our mission. Patients deserve nothing less.
Ginny McBride is the CEO of OurLegacy, a Florida-based OPO. Diane Brockmeier is the CEO of Mid-America Transplant, which serves parts of Missouri, Illinois and Arkansas; she also is the past president of the Association of Organ Procurement Organizations.
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