WASHINGTON — On Wednesday, two transplant doctors, one watchdog and a nephrologist-turned-advocate sat before members of Congress to talk about the nation’s troubled organ transplant system. For over two hours the House Subcommittee on Oversight and Investigations ran through allegations of inefficiency, inertia, negligence and corruption in the groups charged with coordinating transplants throughout the U.S. New, jaw-dropping claims also came to light.
It’s been a year since the private nonprofit United Network for Organ Sharing lost its longtime job as the sole manager of the Organ Procurement and Transplantation Network, or OPTN — a role UNOS had held since 1986. Now, the Health Resources and Services Administration (HRSA) is seeking other contractors to run parts of the massive system that oversees tens of thousands of transplants per year. Disagreements about who should be involved in overhauling the OPTN and how it should be run have delayed that process, Politico reports.
News reports, congressional investigations and, more recently, federal probes, have made glaringly apparent the problems with the current transplant system. Many organs go uncollected, or are thrown out, while people die on the waitlist every day. Just last month, Vox reported that nearly 7,000 donated pancreases went missing. Transportation problems result in canceled transplants and organs gone bad. Patients awaiting a lifesaving graft are often unclear about where they stand, or what their options are.
Those long-simmering issues and others rose to the surface on Wednesday, and with little resistance: Neither the HRSA Administrator Carole Johnson nor OTPN President Richard Formica showed.
Here are five takeaways from the hearing:
Conflicts of interest are a main concern
One theme emerged and reemerged throughout the hearing: unhappiness with the board of directors in charge of the federal transplant network. In the past, members of the UNOS board have also been seated on the OPTN board meant to oversee UNOS, creating a conflict of interest. As part of the reform, HRSA established an independent body this summer to serve as the OPTN board, and hired the American Institutes for Research to organize the election.
However, whenever surgeon Robert Cannon referred to the board, he put “independent” in air quotes. Surgical director of liver transplant at the University of Alabama at Birmingham, Cannon has concerns about just how separate the new group is from the old UNOS guard. Both he and Seth Karp, surgeon-in-chief at Vanderbilt University Medical Center, called for appointed board members.
Karp formerly served on the board of UNOS and the OPTN, as well as the panel that investigated patient safety complaints. “I know what happens on the inside,” he told lawmakers. The OPTN board is still full of people who were on the UNOS board “as recently as a few months ago,” or otherwise involved with the contractor. Karp said he was privy to “self-interest, incompetence” and unsavory tactics: The suppression of data that showed how many organs were discarded, taking credit for increased donations that were actually driven by technological advances and opioid-related deaths, and downplaying a patient data breach that exposed about 1 million medical records, some including sensitive information and Social Security numbers.
Karp, along with Cannon and the other witnesses, called for the new OPTN board members to be replaced.
Allegations of misconduct abound
Greg Segal founded patient-advocacy nonprofit Organize because of his family. Several members, who share a rare genetic condition that causes heart failure, have required heart transplants. Segal’s younger siblings may need new hearts soon, too. In the process of calling for accountability in the system, he’s been “overwhelmed with whistleblower allegations” against the OPTN and regional organ procurement organizations, he said Wednesday. The claims range from kickback schemes — some, like in Alabama, proven and prosecuted — to discrimination, favoritism and bribery in the midst of patient safety investigations. Segal was so swamped with troubling information, he said, that he started referring whistleblowers to Congress or law enforcement.
Appalling allegations got committee members’ attention Wednesday morning. Morgan Griffith, committee chair from Virginia, said he’d heard of prospective donors who were thought to be brain-dead, but woke up on their way to the operating room to have their organs removed. Segal said one such case occurred in Kentucky and is being taken up by the state attorney general.
Cannon said he had a similar experience firsthand (not at his current institution). In the middle of an organ-removal surgery, a nurse anesthetist said the patient had breathed — an act that would contradict a declaration of brain death. When Cannon consulted a higher-up about it, he was told to continue the procedure, “Which, of course, would have been murder,” he told lawmakers. They closed the patient back up and ended the surgery.
Committee member Michael Burgess of Texas called the allegations “some of the most serious” he’d heard in his many years on Oversight and Investigations. Then he set his sights on HRSA, the $15.4 billion agency within the Department of Health and Human Services.
HRSA could strengthen oversight
“HRSA doesn’t seem to be doing the job of oversight that the agency should,” Burgess told the witnesses. They mostly agreed. Jesse Roach, senior vice president of government relations at the National Kidney Foundation, said Congress should put pressure on the agency to hold the OPTN and its local counterparts accountable for mismanagement and wasted organs.
There should also be a new, robust system in place for addressing whistleblower complaints, and open access to data about the transplant system, he said. (Segal said he has been personally retaliated against by OPTN leaders for his work, and knows of whistleblowers who are too afraid to come forward because of the nonprofit’s track record with handling complaints.)
Currently, HRSA relies on the OPTN to gather and share information about how centers and regions are performing. That too should be changed, the witnesses told lawmakers.
But mostly, they urged the agency to act immediately regarding the appointed board for OPTN. That would allow board members to be vetted beforehand, and ensure they are truly independent from the influences of UNOS or other contractors.
Medicare has allowed wide latitude
Organ procurement organizations — of which there are 56 in the U.S. — fall under an old Medicare program that allows them to be reimbursed for all costs, even things seemingly unrelated to patient care, Segal said. That setup has in the past led to Medicare fraud, and could be encouraging the misspending of vital Medicare dollars in the transplant system.
Several audits by the Office of Inspector General have found that OPOs didn’t adequately report overhead, administrative and general costs, or billed for costs that weren’t allowed under Medicare rules. News reports have also exposed OPO leaders for taking lavish trips and buying season tickets to professional sports with money intended for finding and allocating organs to people in need of transplants.
Access won’t be easily improved
Even if all available organs were carefully managed and smartly used, some patients would still wind up on a waitlist, Segal said. Kidney transplants especially are in high demand. About 90,000 people sit on that waitlist.
And then there are the issues of racial equity and discrimination that may get in the way of patients even landing on the waitlist. Black and Hispanic people are less likely than their white counterparts to be waitlisted and to receive a transplant, some studies suggest.
Federal officials don’t have a great understanding of what patients go through before they are approved for the waitlist — the many hoops that may disqualify someone based on less-than-optimal income, social support or mental health. A 2019 report from the National Council on Disability found disabled Americans were denied access to needed transplants — or even medical evaluations for transplant — based on written and unwritten policies.
People in rural areas likewise face access issues. And children in need of transplants often struggle to get them, in part because their smaller body size limits the potential pool of organs.
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