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Patients, advocates, and one rogue organ procurement organization (OPO) executive, among others, pledged support for legislation that aims to disrupt a decades-long monopoly over the U.S. transplant system during a of the Senate Finance Subcommittee on Health Care on Thursday.

"Every day 17 people die while on organ transplant waiting lists and another 13 are removed from the waiting list because they've become too sick to receive a transplant," said Sen. Todd Young (R-Ind.)

LaQuayia Goldring is one of the more than 100,000 people on that list. At age 3, Wilms tumor, a rare kidney cancer, took over Goldring's left kidney. She went into kidney failure and received her first transplant when she was 17. By the time she was 25, she was back in kidney failure.

She has waited "9 agonizing years" for a transplant and is now dependent on dialysis 5 days a week.

Just a few weeks ago, a donor family reached out to Goldring having chosen her for a kidney transplant, but because of a glitch in the United Network for Organ Sharing (UNOS) system, her status was listed as "inactive," she said. She contacted them and was told this was due to a "clerical error."

This was not a one-time error, Goldring noted.

"UNOS technology is unsecure and unreliable and it crashes hourly and, during that time, transplant candidates are not getting phone calls," she said. "Every time this happens, patients like me continue to die."

In addition to these technology problems, in 2020 a Senate Finance Committee investigation uncovered other significant failures of the organ transplant system, including errors in testing and transportation, misuse of Medicare funds, and UNOS's lack of oversight, said Subcommittee Chair Ben Cardin (D-Md.)

At an August 2022 Senate Finance Committee hearing, witnesses described organs delivered in boxes with tire treads or left rotting at airports, and the committee's investigation uncovered hundreds of organ recipients who contracted diseases because of lax screening.

Instead of acknowledging their shortcomings, UNOS has attempted to hide its mistakes, citing "alleged record increases in organ donation," said Sen. Chuck Grassley (R-Iowa). In reality, these increases are the result of "public health tragedies," including the opioid epidemic, and not an indicator of UNOS's performance.

Molly McCarthy, vice chair of the Patient Affairs Committee for the Organ Procurement and Transplantation Network (OPTN) -- and a three-time transplant recipient -- had a front-row seat observing the "gross negligence and abuse" of the government's own contractors.

She reaffirmed Grassley's statements, citing "systematic efforts to misrepresent the facts" by leveraging the opioid epidemic, gun violence deaths, and suicides as evidence of their own achievements.

"All UNOS is celebrating are national tragedies, not evidence of a well-run system," McCarthy said. "What I have observed is that UNOS, at best, treats patients as props. At worst, it outright lies to us, and then uses us as a shield against much-needed oversight and reform. Now, UNOS knows enough not to lie to Congress. So, it lies to its patients instead and then launders those lies through us."

"I have zero confidence that we will ever see improvement if UNOS has any role whatsoever in the transplant system," she added.

Matthew Wadsworth, president and CEO of Life Connection of Ohio, an OPO that manages organ donation in Northwest and West Central Ohio, agreed with McCarthy -- but reserved some blame for CMS.

"The current system is broken," he said. "There are absolutely no guardrails in place to ensure that OPOs are adequately serving patients and many of them aren't."

Because of geographic monopolies, many have become "complacent," even "sluggish," and yet there are no consequences for their poor performance, he noted, adding that CMS has never de-certified an OPO.

In 2020, the agency issued a new OPO rule for the first time in 40 years. However, 3 years later it has yet to say how it will enforce its rule. Additionally, the agency has yet to take action to close a "dangerous loophole" that gives OPOs credit for procuring pancreata that aren't transplanted and instead used for research.

"This means that OPOs that are failing at their central task -- recovering organs for transplant -- can avoid accountability by simply recovering one organ and labeling it research," he said.

In the decades since the National Organ Transplant Act (NOTA) of 1984, the Health Resources and Services Administration (HRSA) awarded the OPTN contract for the network to only one entity: UNOS.

One reason for these repeat contracts is that NOTA only allowed HHS to contract with a "non-profit entity with expertise in organ procurement and transplantation," and has been interpreted as prohibiting the agency from seeking bids from public and private entities that might more effectively manage these contracts.

A new bill, , seeks to break up the organ transplant monopoly by giving HRSA the ability, for the first time, to engage in a competitive process of awarding the OPTN contract.

Wadsworth urged Congress to pass this bill and allow patients to be served by high-performing groups across technology, logistics, data analytics, and other areas critical to improving system performance.

He also called on Congress to "prepare to enforce the OPO rule, without weakening or delaying it, including closing the pancreas-for-research loophole, publishing guidance on how the rule is going to be enforced, and requiring the publication of OPO process data."

Congress also needs to eliminate conflicts of interest that discourage OPOs from investing their resources in areas that grow donation and transplantation, he said.

UNOS issued a on Thursday underscoring its "commitment to modernizing and reforming the nation's organ donation and transplant system and working with Congress to achieve measurable results for patients."

"Patients and families are counting on us to pursue improvements that increase transparency, strengthen accountability, and save more lives. We support calls for patient-focused improvements and want to be part of the solution," said UNOS CEO Maureen McBride, PhD.

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