Every day, around 33 Americans die while waiting for an organ transplant. But new rules aimed at strengthening oversight of the organizations that collect and transport organs are expected to dramatically reduce that number.
The reforms, announced late last month by the U.S. Department of Health and Human Services (HHS) and enjoying bipartisan support, are projected to lead to an additional 7,300 transplants and a $1 billion savings each year after they go into effect in 2022.
There are far fewer organs available for transplant in the U.S. than there are patients who need them. That means the performance of the 58 Organ Procurement Organizations (OPOs) — non-profit groups that enjoy government-enforced monopolies within their geographic area to collect organs from deceased donors and transport them for use in transplant surgery — has life-or-death implications. An OPO that does its job well — one that’s skilled at the delicate task of working with donors’ family members to obtain organs, and that transports them to surgical centers quickly and carefully — can allow for hundreds more life-saving transplants per year than a poorly-run OPO.
And yet, for decades, OPOs have been operating without effective government oversight. Greg Segal, the co-founder of Organize, an advocacy group backed by Arnold Ventures that played a key role in getting the reforms through, calls it “a wildly inefficient and functionally unregulated industry.”
For Segal, the issue is personal. Because of a genetic trait, his father and one aunt have both needed heart transplants — his father waited five years for one — and another aunt died without receiving one. Still, he says, that’s not why he gave up a career in venture capital to get involved. Instead, it was the stark clarity of the issue: that the federal government could save thousands of lives and billions of dollars by making a few simple changes to how it regulates OPOs.
“It’s just one of those issues that, once you look at it, you can’t look away,” Segal said. “I left my job and couldn’t put this thing down.”
To build pressure for reform, Segal worked closely with Jennifer Erickson, an expert on organ donation at the Federation of American Scientists. Erickson first connected with Arnold Ventures as an official in the Obama White House’s Office of Science and Technology Policy.
Self-Reporting and Underperforming
It’s not hard to see why Segal and Erickson were driven to demand change. For the last 40 years, OPOs have been evaluated based only on self-reported information, allowing them to manipulate the data to hide under-performance. In 2015, Organize was awarded a coveted “Innovator in Residence” position in the office of the HHS Secretary. In that role, the group used government data to show the stark difference between how OPOs claimed to be performing in their self-reported stats, and how they were doing in reality.
But it’s even worse than that. Federal courts have said that because the self-reported data is so easily manipulated, it can’t be used to enforce government regulations. That’s created an absurd dynamic in which OPOs know that no matter how poorly they do at procuring and transporting life-saving hearts, kidneys, livers, and lungs, they can’t be stripped of their federal contracts.
“We just got stuck in this cul de sac where you had regulation that was unenforceable but hadn’t changed,” said Segal. “As OPOs realize this, you go off the rails.”
The results in terms of performance are about what you’d expect. Though some OPOs maintain high rates of providing usable organs for transplant, there’s enormous variability — about 470 percent, according to government data — between the best- and worst-run OPOs.
Fraud, Waste and Abuse
One problem area is safely and efficiently transporting organs. Investigative journalists found earlier this year that between 2014 and 2019, nearly 170 organs could not be transplanted because of delays of more than two hours (some organs have a shelf life of anywhere from a few hours to a day and a half, after which they can’t be used). In each case, that means a patient died who would otherwise have been saved. In 2018, an OPO left a human heart on a commercial flight, leading to the pilot turning the plane around after flying for 90 minutes. At a time when we can all track our dinner delivery by GPS, most OPOs still use nothing more sophisticated than phone calls and paper manifests to track life-saving organs in transit.
Fraud, waste, and abuse are also rampant. Salaries for execs have gone as high as $2.5 million, without any correlation with performance. In addition, OPOs participate in the only major Medicare program in which all expenses are 100 percent reimbursed. One Ohio-based OPO paid nearly $4,000 for a private plane — billing most of it to taxpayers through Medicare — for a trip from the Toledo area to Dayton, which would take a little over two hours to drive. Another in California spent $19,000 on a lavish goodbye bash for its retiring CEO, billing taxpayers for almost half the cost. In 2012, the former director of an Alabama OPO was sentenced to over a year in federal prison for his role in a kickback scheme with a funeral home that the OPO did business with.
Under the new rules, OPOs will be evaluated using objective data kept by the Centers for Disease Control and Prevention (CDC). Government regulators will be able to use the CDC data to fire under-performing OPOs and give their contracts to more effective competitors. By introducing the threat of losing a contract, the rules aim to incentivize OPOs to up their game. If the new rules had been in effect this year, 22 out of the 58 OPOs would have automatically lost their contracts, and another 12 would have been at risk of doing so, according to HHS projections.
The reforms are a rare example of a cause that’s been strongly embraced by both sides of the aisle in Washington. They were a top HHS priority under both the Obama and Trump administrations, and were championed in Congress both by conservative Republicans like Sens. Chuck Grassley and Todd Young, and by liberal Democrats like Senator Ron Wyden and Reps. Karen Bass and Katie Porter.
“It’s radically bipartisan,” said Segal, “in an era when we’ve been radically partisan.”