Oversight & Investigations

WASHINGTON, D.C.  – In case you missed it, the Washington Examiner published an article featuring a letter from House Committee on Energy and Commerce Chairman Brett Guthrie (KY-02) and Ranking Member Frank Pallone Jr. (NJ-06), along with Energy and Commerce Subcommittee on Oversight and Investigations Chairman John Joyce, M.D. (PA-13), and Ranking Member Yvette D. Clarke (NY-09), requesting a briefing on HRSA’s ongoing oversight of patient safety in the nation’s organ procurement and transplant system. In Case You Missed It: “House Republicans and Democrats are pressing the Department of Health and Human Services to increase transparency on possible ‘systemic problems’ and ‘threats to patient safety’ in the national organ transplant system, according to a letter obtained by the Washington Examiner. “Bipartisan leadership on the Energy and Commerce Committee wrote to Health Resources and Services Administrator Thomas Engels on Friday, probing whether the agency is able to conduct a wide-ranging review of patient safety after multiple reported incidents of organ donor patients being egregiously mistreated by organ procurement organizations. “Chairman Brett Guthrie (R-KY), along with ranking Democratic Rep. Frank Pallone (NJ), John Joyce (R-PA), and Yvette Clarke (D-NY), said in a joint statement on Tuesday that their investigation into the organ procurement system ‘has demonstrated the need for further oversight’ and that problems may exist nationwide. “The American people should be able to have full faith and confidence in our organ donor and transplant system, and we will continue to work together to prevent these harmful practices from continuing,’ said the bipartisan representatives in their statement. “The Energy and Commerce Committee began its longer-term investigation testimony last fall about a Kentucky patient, Anthony Thomas Hoover II, whose family agreed to proceed with organ donation following an overdose in 2021. “Although Hoover’s neurological condition improved, representatives from the Kentucky Organ Donor Affiliates, the organ procurement organization serving Kentucky, moved forward with the organ retrieval process. Records indicate that Hoover woke up on the operating table before the retrieval surgery, and hospital staff intervened to stop the procedure. “HRSA, which oversees the national Organ Procurement and Transplantation Network and its contractor organ procurement organizations, conducted its own internal investigation into the Kentucky situation following the revelation of Hoover’s case. “The HRSA corrective action plan, issued in May, examined 351 organ procurement cases in Kentucky between December 2024 and February 2025 that did not result in donation. “About 30% of those cases, 103 patients, presented ‘concerning features,’ including 73 patients who showed neurological signs of life after being approved for organ donation surgery and 28 patients who may have survived entirely since there was no cardiac time of death recorded. “Other ‘concerning features’ of the incidents in the HRSA report, according to Guthrie and his House colleagues, include ‘issues related to patient and family interactions, medical assessments and healthcare team interactions, recognition of high neurological function, and recognition and documentation of drugs in patient records.’ “HRSA’s testimony and other public reports suggest that these patterns are not limited to instances detailed in HRSA’s report and may exist in other parts of the country,’ Guthrie and his colleagues wrote. “The bipartisan representatives in their letter cited a New York Times piece published in August about Misty Hawkins, 42, from Alabama, who was taken off life support in the spring of 2024 and prepped for organ donation. Doctors discovered while she was on the operating table that her heart was still beating and she was breathing during her organ retrieval surgery. “Last week, another story came to light of a 22-year-old patient from Kentucky who, in 2019, was taken to surgery to have his organs removed for donation despite still having a heartbeat and not being declared brain dead. “Larry Black Jr., who arrived at the hospital a week prior due to a gunshot wound to the head, was rescued from surgery just in time by another physician. Now at 28, he is a father to three children. “HHS Secretary Robert F. Kennedy Jr. directed HRSA in July to conduct a deeper investigation into the Kentucky organ procurement case, saying that ‘the entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.’ “But the agency has not yet announced plans for a nationwide review of organ transplant systems. “Guthrie and his House colleagues requested that HRSA provide more information on the current status of all patient safety complaints that the agency has received and whether or not HRSA has the capacity ‘to initiate other wide-ranging reviews appropriate, in response to a patient safety complaint that may suggest a systemic problem.’ “The committee requested a staff-level briefing no later than September 26. “Americans’ confidence in the system comes when patient safety is protected,’ said the bipartisan House coalition.”   ###

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, issued the following statement in response to an announcement by the Department of Health and Human Services (HHS) of a decision to decertify the organ procurement organization (OPO) covering South Florida, as well as new efforts by the Health Services and Resources Administration’s (HRSA) to improve operations within the organ procurement and transplant system. “It is critical to ensure that all entities involved in the organ procurement and transplantation process operate safely, and we are grateful to HHS for their instrumental action taken today to mitigate some of the harmful practices that have come to light through rigorous investigations by this Committee and HRSA,” said Chairmen Guthrie and Joyce. “The Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on issues related to patient safety in July and will continue working to protect patients and their families to restore trust in our nation’s organ procurement and transplant system. We applaud HHS for building upon those efforts through the actions taken today and look forward to continuing to work with them.”   Background:   Today, HHS announced it is moving to decertify an Organ Procurement Organization (OPO)—the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System—after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors.  HHS also announced reforms to restore integrity and trust in the Organ Procurement and Transplantation Network (OPTN), including:  Imposing safeguards to prevent line-skipping in organ allocation, immediately protecting nearly 300 patients.  Holding a special election, which spurred record turnout, to install an independent OPTN board.  Establishing a strengthened misconduct reporting system, giving patients and providers a direct channel for safety concerns.  Creating a transparency tool that shows when organs are allocated outside the standard match list.  Removing “DEI” provisions from the 2024 IOTA model to ensure procedural fairness.  Through its extensive investigation, the House Committee on Energy and Commerce has uncovered concerning practices in our nation’s organ procurement and transplant system.   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 also identified by HRSA’s investigation.    On September 12, 2025, Chairmen Guthrie and Joyce and Ranking Members Pallone and Clarke wrote a letter to HRSA requesting a briefing on its ongoing oversight of patient safety in our nation’s organ procurement and transplant system.  ###

WASHINGTON, D.C.  – House Committee on Energy and Commerce Chairman Brett Guthrie (KY-02) and Ranking Member Frank Pallone Jr., (NJ-06), along with Energy and Commerce Subcommittee on Oversight and Investigations Chairman John Joyce, MD (PA-13), and Ranking Member Yvette D. Clarke (NY-09), wrote to the Health Resources and Services Administration (HRSA) requesting a briefing on its ongoing oversight of patient safety in our nation’s organ procurement and transplant system.   In July, the Committee’s Oversight and Investigations Subcommittee held a hearing in response to a HRSA investigative report that found patient safety concerns at Kentucky Organ Donor Affiliates (KYDA) – the organ procurement organization (OPO) serving the state of Kentucky. In the investigative report, HRSA revealed that of the 351 cases reviewed, 103 cases (29.3 percent) showed “concerning features.” These 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.   In addition, HRSA issued a corrective action plan to address the findings in its report specific to KYDA and directing the Organ Procurement and Transplantation Network (OPTN) Board of Directors to develop certain safety guidelines for the entire OPTN. The corrective action plan raised further questions about the possibility that there may be more systemic issues at OPOs across the country, noting that “ [s]ince the review of KYDA was initiated, HRSA has received reports of similar patterns of high risk [donation after circulatory death] procurement practices at other OPOs .” Moreover, during the July hearing, HRSA’s Organ Transplant Branch Chief, Dr. Raymond Lynch was questioned about the potential failure to adhere to existing protocols by Rep. Erin Houchin (IN-09): “ is it a broader systemic issue or is it limited to KYDA ?” Dr. Lynch responded that “ [u]nfortunately, it is not limited to KYDA. During the course of this investigation we received concerns that were in areas served by other OPOs. ”  Chairmen Guthrie and Joyce and Ranking Members Pallone and Clarke issued the following joint statement:    “ The Committee’s examination of the organ procurement and transplant system has demonstrated the need for further oversight.  Testimony from the July hearing, HRSA’s investigative report and corrective action plan, and continued reports of similar patterns at other OPOs all raise serious concerns. The American people should be able to have full faith and confidence in our organ donor and transplant system, and we will continue to work together to prevent these harmful practices from continuing. Americans’ confidence in the system comes when patient safety is protected. ”    Read the full letter  here . Background:  ·       During the 118th Congress, the Committee on Energy and Commerce  passed  the Securing the U.S. Organ Procurement and Transplantation Network Act to both modernize the 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 Virgina, and Indiana.  ·       On May 28, 2025, HRSA issued a  CAP  to 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.   ###

WASHINGTON, D.C.  – House Committee on Energy and Commerce Chairman Brett Guthrie (KY-02) and Ranking Member Frank Pallone Jr., (NJ-06), along with Energy and Commerce Subcommittee on Oversight and Investigations Chairman John Joyce, MD (PA-13), and Ranking Member Yvette D. Clarke (NY-09), wrote to the Health Resources and Services Administration (HRSA) requesting a briefing on its ongoing oversight of patient safety in our nation’s organ procurement and transplant system.   In July, the Committee’s Oversight and Investigations Subcommittee held a hearing in response to a HRSA investigative report that found patient safety concerns at Kentucky Organ Donor Affiliates (KYDA) – the organ procurement organization (OPO) serving the state of Kentucky. In the investigative report, HRSA revealed that of the 351 cases reviewed, 103 cases (29.3 percent) showed “concerning features.” These 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.   In addition, HRSA issued a corrective action plan to address the findings in its report specific to KYDA and directing the Organ Procurement and Transplantation Network (OPTN) Board of Directors to develop certain safety guidelines for the entire OPTN. The corrective action plan raised further questions about the possibility that there may be more systemic issues at OPOs across the country, noting that “ [s]ince the review of KYDA was initiated, HRSA has received reports of similar patterns of high risk [donation after circulatory death] procurement practices at other OPOs .” Moreover, during the July hearing, HRSA’s Organ Transplant Branch Chief, Dr. Raymond Lynch was questioned about the potential failure to adhere to existing protocols by Rep. Erin Houchin (IN-09): “ is it a broader systemic issue or is it limited to KYDA ?” Dr. Lynch responded that “ [u]nfortunately, it is not limited to KYDA. During the course of this investigation we received concerns that were in areas served by other OPOs. ”  Chairmen Guthrie and Joyce and Ranking Members Pallone and Clarke issued the following joint statement:    “ The Committee’s examination of the organ procurement and transplant system has demonstrated the need for further oversight.  Testimony from the July hearing, HRSA’s investigative report and corrective action plan, and continued reports of similar patterns at other OPOs all raise serious concerns. The American people should be able to have full faith and confidence in our organ donor and transplant system, and we will continue to work together to prevent these harmful practices from continuing. Americans’ confidence in the system comes when patient safety is protected. ”    Read the full letter  here . Background:  ·       During the 118th Congress, the Committee on Energy and Commerce  passed  the Securing the U.S. Organ Procurement and Transplantation Network Act to both modernize the 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 Virgina, and Indiana.  ·       On May 28, 2025, HRSA issued a  CAP  to 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.   ###

WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, along with Reps. Palmer (AL-06), Carter (GA-01), Bilirakis (FL-12), and Obernolte (CA-23), penned a letter to the Executive Director of Covered California (CoveredCA), Jessica Altman, to request further information related to the potentially unauthorized transmission of sensitive personal health information involving Covered California’s website. Key Letter Excerpt: “According to public reports and agency statements, tracking technology was embedded on Covered California's website beginning in February 2024, as part of a broader digital advertising effort, and in direct contravention of the tracking platform’s user agreement, which prohibits the use of such tools on pages that collect sensitive health information. Although the tags were reportedly removed in April 2025, following external scrutiny and a vendor transition, the extended period of data exposure raises serious questions about the adequacy of safeguards that Covered California had in place. Forensic testing by investigative reporters identified the trackers in operation and confirmed that user-entered health information was being transmitted to third parties without consent. These circumstances warrant examination of Covered California’s actions under federal privacy standards.” “Ensuring the confidentiality of health information is a foundational obligation for entities operating within the health insurance ecosystem. Federal privacy protections, particularly the Health Insurance Portability and Accountability Act (HIPAA), establish expectations for how covered organizations handle sensitive data. Recent reports and public filings raised questions about whether those expectations were met in this case, and whether existing oversight mechanisms are sufficient to detect and prevent improper disclosures.” Background: Forensic testing shows Covered California —the State of California’s official health insurance marketplace—has been sending sensitive user health data to third-party websites through several online data trackers. Prior to removal of the trackers, CoveredCA had more than 60 trackers active on its website; the average number of trackers on a government website is three. Some types of information sent to such websites include: Searches for doctors in network with specific plans/specializations Demographic information, including gender, ethnicity, and marital status Length of treatment a patent received by a provider Frequency of doctor visits If the user indicated they were blind, pregnant, a victim of domestic abuse, or used prescription medications. The State of California independently operates CoveredCA. As the state’s official ACA marketplace, CoveredCA falls under the purview of Health Insurance Portability and Accountability Act (HIPAA). The disclosure of information such as pregnancy or prescription drug use without proper consent—even for “marketing purposes”—may violate HIPAA. This Congress, the Committee has sent letters to 23andMe and DeepSeek over potential data privacy concerns: The Committee also held a hearing last Congress on the Change Healthcare hack, where personal health information was also jeopardized. CLICK HERE to read Fox News coverage of the letter. CLICK HERE to view the full letter. ###

WASHINGTON, D.C.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Gus Bilirakis (FL-12), Chairman of the Subcommittee on Commerce, Manufacturing, and Trade, and Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, sent a letter to 23andMe regarding the handling of Americans' sensitive data following the company's decision to file for bankruptcy. KEY EXCERPT: “According to 23andMe’s privacy statement, in a bankruptcy, customers’ ‘Personal Information may be accessed, sold or transferred as part of that transaction and this Privacy Statement will apply to [customer] Personal Information as transferred to the new entity.’ Additionally, a judge recently ruled 23andMe has the right to sell the sensitive medical and genetic information of its 15 million customers, which is considered to be the company’s most valuable asset. With the lack of a federal comprehensive data privacy and security law, we write to express our great concern about the safety of Americans’ most sensitive personal information.” Background: On March 23, 2025, 23andMe initiated Chapter 11 bankruptcy proceedings, which could have ramifications for the highly sensitive information of millions of Americans. While Americans’ personal health information is protected under the Health Insurance Portability and Accountability Act (HIPAA), these protections only apply if the information is collected by a HIPAA covered entity. Generally, direct-to-consumer companies, like 23andMe, are not covered by HIPAA. Customers have reported issues accessing and deleting their data from their 23andMe accounts. The Chairmen have requested answers to the following questions: If 23andMe were to sell the personal information of its customers either as a standalone asset or as part of a broader sale of the company, what post-sale data privacy and security protections would be in place for its customers’ personal information? Please describe how the representations made in 23andMe’s privacy statement will continue to apply—and be enforced—if the personal information of 23andMe’s customers is sold to a third party. Please include in this response information about what, if anything, would hold a third-party buyer to 23andMe’s privacy statement or prevent it from subsequently using, transferring, or otherwise selling, such information in the future. Does 23andMe plan to change its privacy statement at any time prior to selling any customers’ personal information? If so, please explain the change 23andMe plans to implement and when those changes will go into effect. Does 23andMe intend to vet prospective buyers to which it may sell its customers’ personal information? If so, please detail the vetting process and whether it will include the prospective buyer’s history of implementing data security protections and compliance with sectoral, state, or any other data privacy and security laws. If not, please explain why. Please detail the categories of customer information 23andMe has, and of that what 23andMe is considering selling. Has 23andMe notified its customers of the company’s bankruptcy announcement? If so, please attach the customer notification. If not, please explain why. Has 23andMe provided its customers with a guide for how to delete, or request to delete any information currently in 23andMe’s possession? If so, please provide a copy of that guide and specify when it was provided to customers. If not, please explain why, and explain whether 23andMe will contact each of its customers and provide an opportunity to delete their personal information prior to a potential sale of the company or personal information maintained by the company. Please detail the number of requests 23andMe received from its customers to delete their personal information between when 23andMe filed for bankruptcy and the date of the response to this letter. Of those requests, please provide a breakdown of how many requests were made by customers through their 23andMe online accounts and how many were made via customer service calls because customers were unable to successfully delete their information through their online accounts. Of those requests, please detail the number of fulfilled requests. Will 23andMe offer for sale any information in which a customer has requested the deletion of such information? If so, does 23andMe’s privacy policy consider selling information a legitimate purpose for retaining information past a customer's request to delete their information? Will 23andMe deidentify its customers’ personal information prior to selling it or the company? If so, please detail which information will be deidentified. If not, please explain why the company is electing not to deidentify information. CLICK HERE to read the full letter. CLICK HERE to read the story from CNBC. ###