Organ Transplant Groups Push HHS on Decertification Process

February 13, 2024 11:51 am


The nonprofit groups that solicit, retrieve, and transport human organs for transplantation say the Biden administration should issue long-awaited guidance on how a revamped decertification process for the groups will unfold in 2026.

Nearly three-fourths of organ procurement organizations (OPOs) were either failing in their responsibilities or under-performing, the Centers for Medicare & Medicaid Services reported in 2023. This includes 24 OPOs—42%—that were operating at the lowest-performing “tier 3” level.

If these OPOs fail to improve their performance in 2024, they could face decertification from the federal organ transplant program in 2026, “presenting a real risk of systemic disruption,” the Association of Organ Procurement Organizations said Thursday.

“If nearly half of the country’s OPOs close in 2026, as is presently forecasted, hundreds of thousands of Americans currently registered on the transplant wait list, and those yet to be referred for transplant, are at risk of experiencing serious disruptions in care,” the association said in a statement. Yet “CMS has yet to share a plan for how a transition after vast de-certification would unfold.”

More than 40 members of Congress expressed similar concerns to the CMS in November 2023.

In a January response to the letter to each of the congressional co-signers, CMS Administrator Chiquita Brooks-LaSure said the agency is developing a proposed rule on the standards to evaluate and recertify OPOs.

“CMS is reviewing our OPO competition and de-certification processes, and any changes would be made through future rulemaking. We expect that any revisions will continue to hold OPOs responsible for improved performance,” Brooks-LaSure’s letter said.

‘Considerable Uncertainty’

The association was not satisfied by the response.

“There is considerable uncertainty around how this new re-certification process will work and numerous unanswered questions,” the group’s release said. “Our members are seeking clarity on the ground rule for competition; the process by which proactive mergers can take place, and how OPOs that want to acquire de-certified OPOs can do so; and, perhaps most importantly, what the process looks like for an OPO faced with de-certification.”

The nation’s organ procurement organizations identify potential organ donors, request consent from donor families if there’s no documentation, procure organs, and work to identify potential transplant recipients. They also help ensure that organs are delivered to transplant hospitals.

But in recent years, they’ve faced persistent criticism for questionable spending practices, poor performance, and not making enough organs available for transplant.

In their release, the AOPO said the non-utilization rate of kidneys reached a record high of 28% last year. “Last year, more than 8,500 kidneys that were recovered by OPOs and offered to transplant centers for patients in need were ultimately declined and unused,” it said.

This issue is highly concerning “because of its consequences for patients,” the group said. “Non-utilization leads to the unnecessary deaths of thousands of transplant patients each year who placed trust in our donation and transplant system to save their lives.”

The nation’s OPOs are assessed mainly on their organ donation rates and organ transplantation rates. But after an organ is recovered, an OPO has little to no control over whether it is actually used for transplantation. So the “transplant rate” reflects a transplant center’s decision, not OPO performance, but it still significantly affects an OPO’s ranking.

“The nation’s organ donation system is on the verge of collapse as nearly half of the nonprofits responsible for recovering organs nationwide are at risk of decertification by CMS, with no plan for transition,” Colleen McCarthy, the association’s president, said in a statement to Bloomberg Law.

“We urge CMS to immediately provide a detailed plan for ensuring America’s transplant patients will experience no disruptions should the agency dissolve 42% of organ procurement organizations,” she said.