WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman John Joyce, M.D. (PA-13), Chairman of the Subcommittee on Oversight and Investigations, sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting a briefing to better understand the Department of Health and Human Services’ (HHS) recent actions and ongoing work to enhance safety within the organ procurement and transplantation system. On Thursday, September 18, 2025, the Department of Health and Human Services (HHS) announced major efforts to improve safety, transparency, and efficiency within the organ procurement and transplantation system, including the decertification of an organ procurement organization (OPO) for the first time in U.S. history. According to the announcement , the decision was made “after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors.” The Committee has a history of ensuring patient safety remains the highest priority in our organ procurement and transplantation system, as evident from the Committee’s work last Congress on organ transplantation and donation issues as well as its oversight this Congress. As a part of its ongoing investigation, the Committee requests that CMS respond to questions, including those related to the decertification of the OPO in South Florida and the prevalence of incidents similar to those outlined in the Health Resources and Services Administration’s (HRSA) investigative report, to ensure patient safety remains a top priority. Read the full letter HERE . “While the Committee applauds efforts taken by CMS to uphold the highest standards of care to which all OPOs are expected to adhere, HHS’s announcement decertifying the Life Alliance Organ Recovery Agency illustrates the urgency of this moment and why the subcommittee is not finished with our oversight of the organ transplant system,” said Chairmen Guthrie and Joyce. “It is our moral obligation as members of Congress to establish safeguards and prevent these harmful practices from persisting further, and we look forward to obtaining answers from the agency about the prevalence of these incidents, as well as how CMS plans to proceed with prioritizing patient safety first and foremost.” Background: During the 118th Congress, the Committee on Energy and Commerce led the passage of the Securing the U.S. Organ Procurement and Transplantation Network Act to both modernize the Organ Procurement and Transplantation Network (OPTN) and allow HRSA to institute a competitive contracting process to find the best contractors for various OPTN functions. This legislation was signed into law on September 22, 2023. On March 20, 2024, the Committee launched an investigation into the organ procurement and transplantation system by sending a letter to United Network for Organ Sharing (UNOS) requesting information related to concerns surrounding data security and operability, patient safety and equity, and conflicts of interest. On March 20, 2024, the Committee also sent a letter to HRSA requesting information related to implementation of the Securing the U.S. Organ Procurement and Transplantation Network Act as well as other concerns related to effective oversight and management. On September 11, 2024, the Subcommittee on Oversight and Investigations held a hearing that focused on the implementation of reforms at the OPTN, including the need for stronger oversight and accountability as well as ongoing patient safety concerns. During the hearing, questions were raised related to allegations of mismanagement and patient safety concerns after patients began exhibiting signs of increased neurologic function after being previously deemed suitable as an organ donation candidate. Several of these allegations, particularly those related to patient safety, were later substantiated through the findings contained in HRSA’s March 2025 report. On March 24, 2025, HRSA’s Division of Transplantation issued a report that summarized the findings of its investigation into KYDA, the OPO now known as Network for Hope, which serves Kentucky and parts of Ohio, West Virginia, and Indiana. HRSA’s investigation examined an “index case” and an additional 351 unique cases of authorized, not recovered (ANR) patients. This means that the patients were considered for donation after circulatory death recovery, but no organs were transplanted. The report showed that nearly 30 percent of the cases “had concerning features.” The concerning features included problems with patient-family interactions, medical assessments and team interactions, recognition of high neurologic function, and recognition and documentation of drugs in records. On May 28, 2025, HRSA issued a corrective action plan to the OPTN, which directed the OTPN to take specific actions within a specified period of time, including developing a 12-month OPTN monitoring plan for KYDA to address concerns identified. The corrective action plan also requires the OPTN to propose policies for public comment to improve safeguards for potential donation after circulatory death (DCD) patients in the organ procurement process and increase information shared with patient families regarding DCD organ procurement. On July 22, 2025, the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing examining concerning practices within our nation’s organ procurement and transplant system that were identified by HRSA’s investigation. On September 12, 2025, the Committee sent a bipartisan letter to HRSA requesting a briefing on its ongoing oversight of patient safety in our nation’s organ procurement and transplant system. ###
