Biden Administration Announces Plan to Overhaul the Organ Transplant System

The Biden administration said Wednesday it is launching an initiative to modernize the current organ procurement system to give it greater accountability and transparency.

"Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network (OPTN) to save the lives of their loved ones who experience organ failure," Carole Johnson, administrator of the Health Resources and Services Administration (HRSA), said in a press release. "At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less."

The beginning phase of the modernization initiative includes these steps:

Making more data available. Starting Wednesday, HRSA will publish organ donation and transplantation data on a data dashboard "to inform decision-making as well as process improvements," the agency said in the release. "Today's launch is an initial data set, which HRSA intends to refine and update regularly over time."

Acquiring funding for modernization. President Biden's proposed fiscal year 2024 budget would more than double the resources available to support HRSA's organ transplantation programs, including the OPTN Modernization Initiative ($67 million), according to the release. The budget also would remove the appropriations cap on OPTN contracts "to allow HRSA to better allocate resources" and expand the pool of entities that are eligible to compete for contracts to support the OPTN, in order "to enhance performance and innovation through increased competition." So far, only one organization, the United Network for Organ Sharing (UNOS), has been administering the OPTN.

Increasing modernization capacity. HRSA said it has "procured program management support services" to help engage a wide variety of stakeholders in the modernization.

Ongoing consultation with the U.S. Digital Service (USDS). HRSA will consult with USDS -- a White House office aimed at delivering "better government services to the American people through technology and design" -- as it works to create an agile approach to OPTN information technology modernization.

Collaborating with industry. In late Spring, HRSA will give industry stakeholders a "high-level overview" of its modernization efforts and how vendors can participate.

Soliciting modernization proposals. HRSA said it "intends to issue contract solicitations for multiple awards to manage and improve the OPTN. HRSA also intends to further the OPTN Board of Directors' independence through the contracting process and the use of multiple contracts."

The current organ donation system has had its share of controversy. One study published last month found that of 931 potential organ donors identified at 13 hospitals covered by two organ procurement organizations, only 242 donors, or 26%, actually had organs recovered. And at a hearing last August, members of the Senate Finance Committee and fellow witnesses roasted the head of UNOS over what committee chair Sen. Ron Wyden (D-Ore.) characterized as "gross mismanagement and incompetence." Witnesses described organs delivered in boxes with tire treads or left rotting at airports, and the committee's 2.5-year investigation uncovered hundreds of organ recipients who contracted diseases because of lax screening.

At a Senate Appropriations Committee subcommittee hearingWednesday on the HHS budget, Sen. Jerry Moran (R-Kan.) pressed HHS Secretary Xavier Becerra to do more on the issue, specifically as it related to a 2018 rule -- implemented in 2020 -- on liver allocation.

"Sen. Roy Blunt [R-Mo.] and I have continually flagged for your department how harmful and unfair the rule is to the Midwest and the South," Moran said, noting that a Washington Post investigation found sharp declines in transplant surgeries in Puerto Rico and seven states -- all but one Southern and Midwestern. "Could you please confirm your department's commitment to working with my office with Congress to improve the OPTN system for all Americans?"

"You had me at hello," Becerra replied. "We are going to open up the process so that this one contractor doesn't believe that it owns this shop. And we're hoping that through competition, we're going to really be able to open this up in a way that lets the best of those who could offer the service take over the contract."

In an email to MedPage Today, UNOS said on Wednesday that it agreed with the modernization initiative. "UNOS supports HRSA's plan to introduce additional reforms into the nation's organ donation and transplantation system," read the statement. "We also stand united with HRSA in our shared goal to get as many donor organs as possible to the patients in need while increasing accountability, transparency and oversight."

"We welcome a competitive and open bidding process for the next OPTN contract to advance our efforts to save as many lives as possible, as equitably as possible," the statement continued. "We believe we have the experience and expertise required to best serve the nation's patients and to help implement HRSA's proposed initiatives. Numerous components of HRSA's plan also align with our new action agenda, which is a list of specific proposals we outlined earlier this year aimed at driving improvement across the system."

The National Kidney Foundation also praised the initiative. "Our current transplant system still relies on antiquated technology and inefficient systems that create life-threatening bureaucracy and delays," Kevin Longino, the foundation's CEO and a kidney transplant recipient, said in a statement. "While the overall rate of transplants has increased in recent years, it still falls far short of patient needs … HRSA's move to redesign the OPTN contract will allow leaders in technology, artificial intelligence, supply chain management, and other critical business operations to bring their ideas and talent to a system that is in desperate need of reform."

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