In the News

President Joe Biden’s expected signature will provide the final action needed to give the federal government the authority to break up the monopoly contract used to manage the nation’s troubled organ donation system since 1986.

The Senate on Thursday night used a fast-track agreement to pass H.R. 2544, which would allow—for the first time—competitive bidding on multiple contracts to manage the Organ Procurement and Transplantation Network (OPTN), which maintains a national registry to help match organ donors with needy recipients.

The legislation, which passed the House by voice vote earlier this week, was adopted by the Senate through unanimous consent, an agreement that sets aside procedural rules when there’s no opposition in order to expedite proceedings.

Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) had previously introduced companion legislation, S.1668.

The bipartisan H.R. 2544, which was introduced by Reps. Larry Bucshon (R-Ind.), and Robin Kelly (D-Ill.), would enable public and private entities to bid on OPTN contracts.

Any new contractors would likely compete to assume many of the responsibilities now handled by the United Network for Organ Sharing, or UNOS, which has managed the OPTN network under federal contract since 1986.

A private nonprofit organization, UNOS has long drawn criticism from patients, lawmakers, and patient advocates. They say the organization has been slow to address technology failures, is unaccountable to patients on the organ waiting list, has allowed too many organs to go unused, and has shown little oversight over the regional organ procurement agencies that solicit and collect donated organs.

More than 104,000 people are on a waiting list for a transplant in the US, and 17 die each day waiting for an organ. Another 13 are removed from the waiting list each day because they become too sick for a transplant.

The current OPTN contract with UNOS is set to expire Sept. 30, 2023, and will be up for renewal.

Next Stop: White House

Thursday’s quick Senate passage follows the July 25voice-vote passage in the House.

The legislation will now go to Biden’s desk, where it will be warmly received. The president’s fiscal year 2024 budget featured legislative proposals to “modernize statutory tools” regarding the OPTN. And in March, the Health Resources and Services Administration of HHS announced a massive “modernization initiative” that included bringing competition to the OPTN contract.

In a statement, Grassley said the legislation is “proof that bipartisanship still works in Washington.”

“I’ve been grateful to have support from my colleagues on both sides of the aisle since I first began investigating the organ industry in 2005,” Grassley said. “At long last, Congress has succeeded in untangling years of deadly errors in the organ industry to give patients a better shot at lifesaving care and root out corruption.”

The Senate Finance Committee began a bipartisan investigation into UNOS in 2020. In August 2022, Grassley and Wyden released a 66-page memo with findings from the investigation. It included numerous allegations of mismanagement and other improprieties by UNOS.

At a subcommittee hearing of the Senate Finance Committee on July 20, committee chairman Wyden promised that lawmakers would be “pulling out all the stops to get the Senate to act on this issue as soon as possible,” because “this is a matter of life and death for too many Americans.”

Under UNOS’ watch, the system has been especially harmful to minorities who are disproportionately represented on the organ waiting list but, on average, wait longer for a transplant, and are a higher risk of dying while waiting, Wyden said on the floor of the Senate Thursday.

“This is morally repugnant,” Wyden said. “And this legislation begins, finally, to root out this bias against our minority communities.”

“The last place anybody wants to hear about gross mismanagement and incompetence is in the business of saving lives. It’s time for real accountability and real change,” Wyden said.

In June, UNOS announced that it did not oppose the legislation.

In an earlier statement, UNOS said it supported “modernizing and reforming the nation’s organ donation and transplant system and working with Congress to achieve measurable results for patients.”

“As long as there is a waitlist, it is our moral obligation to ensure we are promoting progress and increasing equitable access to lifesaving transplants,” said Maureen McBride, UNOS’ CEO.

Support for Bill

Patient advocacy groups including the American Society of Nephrology, Global Liver Institute, National Kidney Foundation, and Renal Support Network support the bill. So does the American Hospital Association.

In addition to allowing HRSA to conduct an open competition for OPTN operational contracts, the legislation would:

• Make technical changes to the National Organ Transplant Act of 1984;
• Broaden the eligibility for, and nature of, HRSA contract awards to ensure the OPTN doesn’t have to be run by one entity;
• Give the Department of Health and Human Services more flexibility to manage OPTN contracts by removing a $7 million cap on direct HRSA funding of OPTN contractors; and
• Require a report by the Government Accountability Office to help Congress better understand how OPTN is financed.