You probably haven’t heard of organ procurement organizations, but if you or anyone you know has ever received an organ transplant, they’re the ones who procured it. | Christopher Furlong/Getty Images
Below is a graph showing a trend that exploded during the 2020s:
What is this depicting? Compute use for AI? Crispr gene edits per year?
No, this is another, much less-known example of massive growth these past several years. This is a chart of the number of pancreases (or, to use the correct plural, “pancreata”) collected each year from dead bodies in the US for research purposes:
How this happened is no mystery. The surge is, by all accounts, due to a regulation that took effect in 2021 focused on groups called organ procurement organizations (OPOs).
You probably haven’t heard of OPOs, but if you or anyone you know has ever received an organ transplant, they’re the ones who procured it. OPOs are nonprofit, nongovernmental bodies to which the US outsources the job of collecting organs from deceased organ donors. Each OPO has a monopoly on recovery of all organs in a particular geographic area; there are 55 groups, some of which only cover part of a state and some of which cover multiple states.
For some time now, critics have argued that OPOs are massively underusing deceased donor organs. One report from 2019 estimated that every year 28,000 usable organs (mostly badly needed kidneys but also pancreata, hearts, livers, etc.) are removed from deceased donors but never used; another put the number at 75,000. This, when the national waitlist for organs is more than 100,000 people long.
OPOs are not paid to collect these organs per se: They are entitled to 100 percent reimbursement of costs they report related to retrieving, preserving, and delivering organs, with ultimate payment coming from Medicare or transplant centers (which in turn charge Medicare and other insurers). This system, critics have long charged, does not provide enough incentive to procure harder-to-retrieve organs from patients who may be older or have certain medical conditions.
To get OPOs to collect more organs, the Trump administration in 2019 issued an executive order calling for new rules governing how the organizations are certified by the federal government, rules that were finalized two years later. This was high stakes: If an OPO loses certification, it has to shut down, and another OPO gets its territory. The rules were meant to more strictly grade OPOs on the share of organs they eventually transplant than the earlier, laxer rules did.
But there was a catch. In addition to organs recovered from deceased donors and transplanted, pancreata recovered and used for research would count toward recertification as well. Not any other organs for research — just pancreata.
What happened next can be see in the chart above: a massive, sudden surge in the number of research pancreata being recovered by OPOs, beginning in 2022, the precise year the new evaluation system took effect.
I’ve long been fascinated by this trend, which OPO critics call the “pancreas loophole” and OPO defenders describe as a perfectly legal response to overly onerous regulations. The numbers represent thousands of real, physical human pancreata, taken from real, recently deceased donors, that wouldn’t have been taken from those bodies without this regulation.
I’ve tried in recent months to make sense of how this happened, and what it means. I’m not the only one; the Senate Finance Committee has been investigating, and released a report in early June on the problem.
There is still plenty that remains unknown about the fate of these pancreata (if you work at an OPO or research center and know more details, please email me). But what is clear is that they represent an approach by the federal government toward increasing organ supply that absolutely no one is happy with. If the point of the regulations is to help people in need — including the millions of Americans with diabetes, a disease of the pancreas — evaluating OPOs based on the number of pancreata they donate to researchers simply doesn’t make any sense.
But to understand how we started judging them this way regardless, you have to go all the way back to an obscure law passed in George W. Bush’s first term.
Pancreata (and why you might need one transplanted), explained
Everyone knows, in broad strokes, what the heart or the lungs do. But the pancreas doesn’t have the same level of fame. Its basic purpose is to excrete enzymes, hormones, and other compounds to both 1) help the body digest food and 2) regulate blood sugar levels.
The latter function is performed by the islets of Langerhans, cells in the pancreas (named after their discoverer, 19th-century German researcher Paul Langerhans) that secrete two different hormones: insulin (to lower blood sugar) and glucagon (to raise it).
In Type 1 diabetes, the ability of the pancreas to produce insulin is impaired and thus blood sugar levels are dangerously elevated; in some kinds of Type 2 diabetes, the body develops resistance to insulin’s effects. Typically, people with diabetes deal with this through injecting insulin directly, a process that has become much more sophisticated in recent decades as finger pricks and needles have given way to insulin pumps that can directly measure and adjust blood sugar levels.
But even with advanced care, diabetes carries lifelong medical consequences, so researchers have long sought a more permanent fix: What if you could replace or supplement the faulty islet cells in patients with diabetes with healthy islet cells? Could you, then, cure diabetes at the source and avoid the need for insulin injections and the risk of long-term health effects altogether?
In the most extreme version of this approach, a complete new pancreas is transplanted into a patient with diabetes, like swapping out a faulty part. This is a proven treatment (915 occurred in 2023) and when done it works well, essentially curing the recipient’s diabetes.
But there are major downsides: you have to undertake major abdominal surgery with a small but real chance of failure, and if that succeeds, you have to remain on immunosuppressant drugs for the rest of your life to prevent organ rejection.
For that reason, physicians generally rule that the costs of a pancreas transplant outweigh the benefits for most people with diabetes. Living with an insulin pump is better than risking surgery and having a permanently compromised immune system. Very few of the 38 million Americans living with diabetes, then, are going to be candidates for a pancreas transplant.
This math changes, however, if the patient in question also needs a kidney transplant. Diabetes accounts for nearly half of all new cases of kidney failure, so a higher share of people with diabetes than people without find themselves in this situation. In these cases, since the patient is already going to have surgery and be on immunosuppressants, throwing in a new pancreas to the surgery and curing their diabetes in the same operation that cures their kidney failure begins to look like an attractive option. That’s why almost no one gets a pancreas transplant in the US without getting a kidney transplant too.
A cure for diabetes
For decades, researchers searching for effective diabetes treatments have experimented with an approach called islet cell transplantation.
Rather than transplant the whole pancreas, the procedure merely transplants insulin- and glucagon-producing islet cells into the recipient’s liver. It’s far less invasive, and can be done with local anesthesia and without an overnight hospital stay (though, skeptics argue, often less effective than whole pancreas transplantation too). If the islet cells come from a deceased donor, it does mean a lifetime of immunosuppression, but in “autograft” procedures, which use a subset of still-healthy islets from one’s own impaired pancreas, immunosuppression isn’t necessary.
Islet cell transplantation, though, remains little-used and mostly experimental in the US. Unlike its big brother surgery, though, islet cell transplantation remains little-used and mostly experimental. Part of the reason why is regulatory: While pancreases are legally “organs,” and therefore excluded from regulation by the Food and Drug Administration, the FDA has asserted its authority to also regulate islet cells as human tissues and to require premarket approval before they can be transplanted into a patient, just like a drug would.
To gain such approval, it would be necessary to conduct clinical studies to demonstrate that the islet cells are “safe and effective”; ones approved they would need to be produced in compliance with “good manufacturing practices.” To receive islet cells not approved by FDA, a patient would need to join a clinical study (if one is being conducted) or go to a country (including Canada, Australia, and several EU and Asian countries) with different regulations.
FDA’s requirements have unsurprisingly slowed the islet cell transplant field down. The most recent data comes from 2021, when only 10 such procedures were performed in the US. In 2012, 111 were performed, but the number has steadily fallen ever since. It’s orders of magnitude rarer than a whole-pancreas transplant.
But islet cell transplants have some champions, including politicians. In 2004, Congress passed, and George W. Bush signed, the Pancreatic Islet Cell Transplantation Act. It was sponsored by Rep. George Nethercutt Jr. (R-WA), who said he was driven by his daughter’s diabetes to try to expand access to islet cell transplants so patients could “live without being dependent on insulin injections.”
Nethercutt’s bill sought to speed up research progress by, among other measures, ensuring adequate supply of pancreata for scientists. The law includes a provision stating, “Pancreata procured by an organ procurement organization and used for islet cell transplantation or research shall be counted for purposes of certification or recertification.”
That meant that when regulators in 2019 were reconfiguring certification rules for OPOs to encourage them to effect more transplants, they had to include a carve-out for pancreata used for islet cell research. The carve-out existed from the very first draft proposal that Trump’s Centers for Medicare and Medicaid Services (CMS) released, and stayed into the final rule in 2021.
The mysterious pancreas boom
That rule’s changes applied for evaluations of organ procurement organizations starting in August 2022. In the years 2018 through 2021, OPOs collected around 500–600 pancreata for research each year. In 2022, that figure was 1,432, a three-fold increase. In 2024, the number hit 2,053. The effect of the new regulation was clear.
It’s important to note that there are no indications that the pancreata being collected by OPOs for research are cutting into the supply of pancreata for donation. The share of dead people whose pancreata are suitable for transplant is incredibly low, because of the exacting standards for donor age and health.
“Only a certain number of donors are going to be young enough (probably less than 50, maybe less than 45) and lean enough (maybe less than 30 BMI, probably less than 27 or 28),” Jonathan Fridell, a transplant surgeon and director of the pancreas transplant program at IU Health in Indianapolis, told me. “We’re still going to look at the people that are older, still look at the people that are heavier, but the likelihood that they’re going to have a transplantable pancreas is lower.” There are thus plenty of non-transplantable pancreata left over that could be used for research once the prime ones are taken away for surgery.
The problem with the surge in research pancreata, then, isn’t that it’s taking pancreata away from recipients who need them. It’s subtler than that. By racking up large numbers of pancreata for research, OPOs are improving the grades they receive from federal regulators, and avoiding the risk of losing certification and having to turn over territory to another OPO. This grading and decertification process was meant to incentivize OPOs to collect more organs for transplant, especially kidneys, which are both easier to transplant than pancreata and more desperately needed. But the research pancreata provide a way around that incentive.
Calculate the grades that OPOs would get without these pancreata versus the ones they are getting now, and you’ll find the results are radically different.
CMS classifies OPOs into three tiers: 1, 2, and 3, with tier 3 OPOs facing decertification. Using data obtained from the organ procurement transplant network, we are able to calculate which tier each OPO would be in with and without their research pancreata based on their performance in 2023. The year that is actually binding for OPOs and determines whether they will be decertification is 2024, for which data does not yet exist, but the 2023 data gives us some indication of which OPOs are using pancreata to save themselves.
For two OPOs, including research pancreata meant they went from tier 3, which would result in decertification, to tier 2: Donor Network of Arizona, which covers that whole state; and OneLegacy, which includes most of Southern California including Los Angeles and Orange counties. Another, Kentucky Organ Donor Affiliates, went from tier 2, where it could face pressure to improve performance, to tier 1, suggesting it excels.
These are not small institutions. OneLegacy is by far the largest OPO in the country by volume of organs collected and population covered. Its CEO, Prasad Garimella, earned $1.1 million in total compensation in 2023, the last year for which public IRS filings are available. It stood a real chance of being decertified if it did not meet the new organ collection standards. And it went from reporting 83 pancreata collected for research in 2021 to 441 in 2022 and 492 in 2023. An over fivefold increase, in one year — and no wonder, given its existence was at stake.
(In response to a request for comment, OneLegacy stated, “When recovering organs for transplant, OneLegacy will allocate pancreata to reputable islet cell research agencies only if they are not viable for transplant into patients. Over 99.6% of pancreata recovered by OneLegacy for research between 2018-2022 were allocated to two National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) laboratories.”)
Again, the 2023 data is not binding. The 2024 data will be. But unless something changes with the way the government evaluates these pancreata, some major OPOs will avoid dire consequences for the sole reason that they started collecting hundreds of pancreata for research.
Where did all the pancreata go?
The increase is so obviously a result of the new rules that OPOs don’t even bother to deny it. Responding to the Senate report earlier this month, the Association of Organ Procurement Organizations, which lobbies for the groups and against the CMS’s stricter rules, said simply, “Today, pancreata recovered for research remain part of the performance evaluation metrics, and OPOs have operated in accordance with the rule.” In other words: yeah, we found a loophole. And what are you going to do about it?
It’s an attitude that has pervaded the industry since the loophole came to light. In a listserv thread discussing the new rules, leaked to the Senate Finance Committee, an OPO employee wrote, “If you have a donor with only a pancreas for research, that is an organ donor for the Donor Rate. Otherwise, a donor is any donor with at least 1 organ transplanted. Savvy (or cynical?) OPOs ought to start a pancreas for research program immediately.”
But there’s a question that remains unanswered: Where did all these thousands of pancreata go?
It is clear that the vast majority of research pancreata did not go into islet transplants. We are talking about thousands of organs, not the few dozen that plausibly could have been transplanted as part of islet procedures in the past couple of years.
Indeed, OPOs have admitted as much. The Centers for Medicare and Medicaid Services asks OPOs for data on organs recovered every year, and in August 2024 clarified that it would only count pancreata as “‘used’ for research if they are accepted for use in bona fide islet cell research conducted by a qualified researcher, such as research approved by the National Institutes of Health.” It then asked OPOs to resubmit their data, clarifying which organs were for islet cell research specifically.
Once they did, the number of reported pancreata fell dramatically:
In 2023, the total went from 3,338 pancreata before the guidance, to 1,812 after, a drop of 46 percent. Some OPOs, like Legacy of Hope in Alabama, now reported zero pancreata for research; before the guidance narrowed qualifying purposes, Legacy of Hope had claimed 226 pancreata.
But even after the change in guidance, we’re left with smaller numbers that are still much too big to be explained by bona fide islet cell transplants. There simply were not 1,812 islet cell transplants in the US in 2023, but there were 1,812 pancreata credited as donated for islet cell research. And that number is still over triple the number claimed in 2021, meaning the increase sparked by the new OPO rules largely remains even after the government’s clarification. Research by David Goldberg, Erin Tewksbury, and Matthew Wadsworth has shown that the number of pancreata reported as recovered by OPOs also swamps the number that the Integrated Islet Distribution Program (IIDP), a consortium that collects and extracts islet cells from pancreata, reports receiving from these OPOs.
One of the points of the Senate investigation was to determine where exactly these pancreata went. The Senate Finance Committee, with the benefit of subpoena power, went about asking major OPOs for what actual purpose the research pancreata were used. The main answer they received was “we don’t know.”
“Many of the OPOs stated that it is the responsibility of the research facilities or institutions receiving the pancreata to inform the OPOs on the purpose, methods, and efficacy of the research being conducted on the pancreata and other organs that OPOs supply,” the report states. In other words, OPOs themselves don’t keep track. “Many of these OPOs,” the report continues, “have sent pancreata to biobanks and other institutions or facilities that hold pancreata for an unknown period to be used for purposes that may be undefined or nonexistent.”
Put another way: These pancreata could, for all the OPOs or the Senate knows, be sitting on a freezer somewhere, not transplanted into anyone. Or maybe not even sitting there at all. Greg Segal, an activist advocating for reform to the pancreas loophole, testified before a House committee that staff at one OPO, joked “that they’re conducting research on the efficacy of garbage disposal A versus garbage disposal B” when disposing of pancreata.
Exploiting the loophole
Throughout all this, OPOs have had one consistent message: They’ve complied with the law, as they see it.
“Pancreata recovered for research remain part of the performance evaluation metrics, and OPOs have operated in accordance with the rule,” the Association of Organ Procurement Organizations, the groups’ lobbying shop in Washington, said in its statement after the Senate investigation was released. “When CMS issued clarifying guidance in 2024 limiting this metric to pancreata used for islet cell research, OPOs responded immediately and worked with the agency to validate data and ensure compliance.”
Jedd Lewis, CEO of the Organ Preservation Alliance and a decades-long veteran of the transplant field, notes that CMS’s rule neglected to define what it means to use a pancreas for research, despite many OPOs and industry experts specifically flagging the problem for CMS before that rule took effect. And CMS’s new guidance last year did little to solve the problem, he argues.
“Last years’ memos simply identified the scope of pancreas donations that OPOs would be judged on as those for ‘islet cell research.’ But CMS didn’t define what that actually means …and on its face it’s a huge scope of research,” Lewis wrote in an email. “There are so many … ways that researchers are looking at how those cells function: studying the pancreas whole, slicing it into thin sections, isolating the individual islet cells, even breaking the cells into the component parts.” That’s all valuable research, he argues, and clearly relates to islet cells, even if the pancreata are never actually used in islet cell transplants.
Wadsworth, a coauthor on the study finding a surge in research pancreata and CEO of the LifeConnection OPO in northwest Ohio, concedes that counting pancreata that did not produce islet cells for transplant may technically be legal. But he still thinks it’s wrong.
“I worked with this surgeon early on in my career who said ‘just because you can do something doesn’t mean you should,’ Wadsworth noted. “Based on what’s written, maybe they didn’t do anything wrong, but you don’t have to look far back in history to find examples where something wasn’t illegal, but it definitely wasn’t right either.”
LifeConnection, Wadsworth says, was able to comply with the spirit of the CMS regulations by finding counties in its jurisdiction where low numbers of organs were being procured, and working on fixing the problem hospital-by-hospital. It’s harder than just harvesting pancreata, but it means organs get transplanted to people who need them.
One irony of the controversy is that most OPOs, and their representatives, don’t believe that research pancreata should count for their evaluations. “AOPO has concerns about including pancreata utilized for research in the data used to calculate the numerator of either proposed measure,” the Association of Organ Procurement Organizations wrote in an early 2020 comment as the regulations were being developed. “The utilization of pancreata for research is driven by demand of local researchers. Inclusion of pancreata for research in the data utilized for the numerator may skew comparisons of OPOs in that category and potentially lead to inaccurate conclusions.”
But both the OPOs and their regulator, CMS, were bound by the 2004 law requiring that research pancreata, at least that for islet cell research, must count for these evaluations.
Close the pancreata gap
We are running out of time to fix this problem. If nothing changes, OPOs will be evaluated on the basis of data they’ve submitted now, including hundreds of pancreata that were never used for islet cell transplants. Whether you think that reflects OPOs complying in good faith, or subverting the system, it’s not a policy anyone should think makes much sense.
CMS has some ability to act here — but perhaps the best fix would come from Congress in the form of a legal provision clarifying the 2004 act. Simply repealing the provision restricting how OPOs can be evaluated would be simplest — but even better would be pairing it with a legal change that could help islet transplantation research far more than the 2004 has to date.
Recall that islet transplants currently don’t count as organ transplants in the US. They count as treatments with biological tissue “”If islet cells are solely organs, because they are a subpart of the pancreas, which is an organ under transplant law, then the FDA should not have jurisdiction,” Gail Javitt, a veteran lawyer working on FDA regulatory issues at the firm Hyman, Phelps & McNamara, told me. “However, FDA has taken a different position, that islet cells are a cellular therapy and must undergo premarket approval just like a drug would.” If you want to use it for treatment of a patient, you have to go through them. That has had the practical impact of slowing down the availability of islet cells for transplantation in this country.”
Legally clarifying that islet cells are organs, not cellular therapies, and that they are excluded from FDA oversight then, could go a long way to promoting the treatment. Last Congress, Sen. Mike Lee (R-UT) and Rep. Matthew Rosendale (R-MT) each introduced bills making this change, with exclusively Republican co-sponsors.
But this need not be a partisan issue at all, and if you paired this provision with a repeal of the 2004 law permitting OPOs to count pancreata for research as part of its transplant metrics, you could arrive at a close to ideal system. OPOs would be evaluated on their ability to transplant islet cells, because they’d be organs like any other. They would not be able to get higher ratings by recovering pancreata for research that might just languish on a shelf.
This does require Congress to make a small change. But it’s a small change that should be basically uncontroversial. There’s nothing for most OPOs or for advocates trying to maximize donations to dislike here, and there’s lots for islet cell researchers to love. It’s a small fix that could go a very long way.
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