New HRSA actions take aim at organ transplantation system

Following up on a federal law passed in September to increase competition among organ transplant contractors, the Health Resources and Services Administration (HRSA) is issuing requests for proposals for several different contracts.

The agency also announced new data reporting requirements for pre-waitlist and organ procurement practices along with the implementation of a board of directors, according to a news release Tuesday. This includes new standardization requirements for referral to transplant centers, time to patient assessment and time to organ procurement.

“For the more than 100,000 patients on the organ waitlist and their families, the time for reform is now,” said HRSA Administrator Carole Johnson in a statement. “The steps we at HRSA are taking today demonstrate our commitment to a more fair, well-managed, and high functioning organ transplant system in this country.  Patients in need of organ transplant, their families and people who have committed to being organ donors deserve no less.”

A new Organ Procurement and Transplantation Network (OPTN) board of directors will be installed, independent from other OPTN contractors, with a special election for members within six months of a contract award.

While HRSA said the scope and scale of the awards is contingent on fiscal year 2024 appropriations, the budget proposes a $36 million increase over last year to support modernization efforts.

In September, the Biden administration passed a bipartisan law, the U.S. Organ Procurement and Transplantation Network Act, that opened up the bidding process that previously allowed the United Network for Organ Sharing (UNOS) to be the sole contractor managing the country's OPTN. UNOS said at the time it did not oppose the legislation and it welcomed the new bidding process.

The law also removed a funding cap that is designed to upgrade its IT system as well as introduce transparency. This included a data dashboard that went live in March, which shares de-identified information on donors, procurement, waitlists and recipients.

HRSA said the new OPTN Modernization Initiative was completed after market research and extensive comments from patients, community members and industry experts.