Grassley Praises HHS Action to Restore Integrity in Life-Saving Organ Transplant System

WASHINGTON – Sen. Chuck Grassley (R-Iowa), a former chairman and senior member of the Senate Finance Committee, today praised the Department of Health and Human Services’ plan to modernize the Organ Procurement and Transplantation Network (OPTN). The announcement follows years of bipartisan oversight work spearheaded by Grassley, which uncovered critical system outages and failures by the government contractor to adequately manage life-saving organ procurement.

 

 

“From failures by government networks that match organs with patients, to mismanagement and waste by contractors tasked with harvesting and promptly transferring organs, it’s clear that we need a serious overhaul and improved oversight of these life-saving systems. For too long, contractors have dropped the ball and dodged accountability. I’m grateful that Secretary Becerra is taking steps based on our oversight work to improve these systems and hold contractors accountable,” Grassley said.

 

“Senator Grassley, thank you for the work that you’ve done… This has taken a long time, and thank God that you’ve committed to it,” HHS Secretary Xavier Becerra said today during a Senate Finance Committee hearing. “We’re absolutely going to call on you for your help to try to move this forward [and] get your input. Much of what we’re announcing today is a result of the work that you’ve done over the years.”

 

Grassley also highlighted the importance of exposing corruption in the system and preventing whistleblower retaliation at the United Network for Organ Sharing.

 

Today’s announcement follows separate inquires this week, made by Grassley and colleagues on the Finance Committee, probing below-industry standard performance of computer systems that manage organ transfers as well as  potential abuse of a data collection rules regarding pancreas research.

 

In a letter to the United Network for Organ Sharing (UNOS), Grassley joined Finance Committee Chairman Ron Wyden (D-Ore.) in raising concerns about system outages of DonorNet, the organ transplant waitlist database, which was off-line on February 15. The senators previously called for updates to the Organ Procurement and Transplant Network’s information technology system.

 

“Given our continued concern with the security of UNOS’s critical technology, we request written responses, no later than March 31, 2023, with respect to: (1) of details of the system outage, (2) how information related to the system outage was communicated to the federal government and to the public, and (3) what steps UNOS has put in place to mitigate future risk, including measures to ensure public reporting of technological failures,” Grassley and Wyden wrote.

 

Read the letter HERE.

 

Grassley also joined Wyden and Sens. Ben Cardin (D-Md.) and Todd Young (R-Ind.) in raising concerns about organ procurement organizations (OPOs) exploiting a loophole to falsely inflate their performance after the number of pancreata procured doubled in 2021.

 

“We are concerned some OPOs may be reporting pancreas procurements that are not, in fact, meeting the standard of bona fide research consistent with regulation and statute,” the senators wrote. “Based on communications we have received, we are concerned that many of these pancreata may not have been recovered for legitimate research purposes. This trend raises serious questions about OPO practice regarding procurement of pancreata for transplant in light of the CMS performance metrics.” 

 

The letters, sent to 10 OPOs across the country, request data on the number of pancreata recovered and what purpose they were used for, transplantation or research. The request comes after receiving communications indicating that OPO employees are actively discussing how to exploit new regulations from the Centers for Medicare & Medicaid Services (CMS) to increase their performance metrics.

 

The letter was sent to the following OPOs: One Legacy, Donor Alliance, LifeQuest Organ Recovery Services, Indiana Donor Network, Kentucky Organ Donor Affiliates, Mid-America Transplant, New Jersey Organ and Tissue Sharing Network, LifeBanc, Lifeline of Ohio, and Texas Organ Sharing Alliance.

 

An example of the letters is available HERE.

Grassley has led bipartisan oversight efforts into the organ procurement and transplant system dating back to his time as chairman of the Senate Finance Committee in 2005. In 2019, he partnered with colleagues to shine a light on a liver distribution policy that would adversely impact rural and low-income patients, and sought a comprehensive study on the national organ donor system. In 2020, Grassley launched a probe into the U.S. Organ Procurement and Transplant Network (OPTN) amid allegations of inadequate patient safeguards, failure to use organs and questionable financial practices by some contractors. More on this investigation is available here. In 2021, Grassley and Wyden subpoenaed UNOS, and the Finance Committee convened a hearing on failures of the OPTN in 2022.