House committee launches investigation into organ transplant network

The House Committee on Energy and Commerce has launched a bipartisan investigation into the U.S. organ transplant system – the latest scrutiny of the system following reports from the Senate and whistleblowers alleging its failures and mismanagement.

The move by the committee aims to "ensure successful implementation" of a bipartisan bill that was signed into law by President Joe Biden last September. The law was aimed at breaking up the monopoly system that allowed a private nonprofit --- the United Network for Organ Sharing -- to be the sole contractor managing the country's Organ Procurement and Transplantation Network (OPTN) for over 40 years.

As part of the investigation, the committee sent letters -- obtained first by ABC News -- seeking a wide range of documents from the United Network for Organ Sharing (UNOS) and the Health Resources and Services Administration (HRSA), which is responsible for awarding the contract to manage the organ transplant system.

"The Committee writes to request information related to the United Network for Organ Sharing's (UNOS) role as the sole contractor for the Organ Procurement and Transplantation Network," the letter to UNOS states.

The letter added, "According to HRSA statistics, approximately 17 Americans die everyday waiting for an organ transplant, and a disproportionate number of them are patients of color and/or rural Americans."

The nation's organ transplant system has received scrutiny in recent years amid government reports, congressional investigations and whistleblower accounts that revealed outdated and poor technological infrastructure, mismanagement from organ procurement organizations under UNOS, and errors that included allowing organs to go unused.

"Everybody knows the system has been broken for years, with heartbreaking consequences," White House press secretary Karine Jean-Pierre said in September.

An investigation by the Senate Finance Committee launched in 2020 found that "serious errors in the procurement and transplant system are shockingly common."

The committee found at the time that some of the errors included failure from organ procurement organizations to complete mandatory tests for things like blood types and errors in delivering organs.

"It's reasonable to assume that many more errors are going unreported," the Senate Finance Committee said in a report. "Why? Because filing official complaints with UNOS appears to accomplish zero productive oversight or reform."

"Complaints went in, UNOS went quiet," the Senate Finance Committee added.

The Senate Finance committee also found that "hundreds of people" developed diseases from transplanted organs, and that 70 people died between 2007 and 2015 from those illnesses.

The law that Biden signed is partially a result from that investigation as it pushed to break the monopoly that UNOS had as the sole contractor managing the OPTN.

The new investigation by the Committee on Energy and Commerce, according to the letters, aims to ensure "successful implementation" of the bill signed into law by Biden. The bill seeks to increase competition among contractors, gain additional funding and improve the OPTN.

In the letter to UNOS CEO Maureen McBride, the committee requested information on UNOS' data and IT system, a breakdown of "an additional 35,000 deaths of waiting list candidates and transplant recipients," and an explanation of their protocols and procedures to inform HRSA of "adverse events and potential patient safety concerns."

The energy and commerce committee also requested a comprehensive account of all patient-safety complaints and allegations regarding the misuse of medical advice and "documentation of all compensation or other financial interests" from the UNOS executives and board of directors.

"UNOS has been the sole organization managing the OPTN, during which time concerning reports have emerged that the organ donation system has become unsafe, inequitable, self dealing, and retaliatory," the letter states. "The Committee supports HRSA's proposed reforms to make the contracting process truly competitive to help ensure patients are served by the best contractors for each function."

A spokesperson for UNOS did not respond to ABC News' request for comment.

In a hearing before the Senate Finance Committee in 2022, then-CEO of UNOS, Brian Shepard, defended the organization and said UNOS "is dedicated to continuously improving, monitoring and adapting."

"From transportation to technology, from equity to system-wide improvements, by building on the successes of our national system and our community's ongoing efforts on all fronts, we can come together around these shared goals," Shepard said.

Following his testimony, Shepard called many of the allegations against UNOS "misperceptions" in a letter and said the Senate committee "misunderstood the role UNOS has been assigned by the government within the nation's organ donation and transplant system."

HRSA, which said it has taken steps to resolve some of the issues playing the organ transplant industry, also received a letter Wednesday for information and documents related to its contract with UNOS and how the agency plans to support multiple contracts with other companies.

"Errors and inefficiencies in OPTN management can have deadly consequences," the letter states. "As HRSA proceeds through the solicitation and review process for new OPTN contracts, the Committee wants to know how the agency plans to structure, award, and exercise ongoing oversight of the contracts, and about its past experience contracting with UNOS."

In a press release last month, HRSA said that for the first time in four-decades, the agency is "issuing requests for proposals in advance of executing multiple different contract awards."

"In 2023, new legislation reformed the decades-old statute, enabling HRSA to fundamentally transform the system and make multiple different contract awards to access best-in-class vendors," HRSA said.

Greg Segal, the CEO of Organize, a watchdog organization focused on patient safety, health equity, and anti-corruption in organ donation, told ABC News that reform on the organ transplant system is overdue.

"UNOS and OPOs represent a multi-billion dollar industry which has been abusing patients and taxpayers for decades," Segal said.