Health

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 . – Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s legislative hearing on policies to enhance seniors’ access to breakthrough medical technologies. Subcommittee Chairman Griffith’s opening statement as prepared for delivery: “Today’s legislative hearing will focus on several bills aimed at enhancing seniors’ access to life-saving and life-sustaining breakthrough medical technologies.   “These policies are essential to reducing  regulatory barriers to help patients get timely access to care while also bringing more transparency into the coverage process at CMS. “I think we can all agree that federal agencies can be inefficient and very bureaucratic in instances. “It is our job as Congress to ensure that patients are able to access treatments, screenings, or devices in a timely manner, especially if there are no other alternatives on the market. “This hearing is the next step in the process. “One of the bills we are considering is H.R. 842, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, led by Representatives Arrington and Sewell, would establish a new coverage pathway at CMS for multi-cancer early detection screening test—so that once these tests are approved by FDA, Medicare beneficiaries can access these tests in a timely manner. “These multi-cancer screening tests allow for patients to take a blood test to screen for over 50 different types of cancers. “This allows us to do additional testing to narrow the results down to one potential cancer and yields a low false positive rate. “It is essential that Medicare beneficiaries can get screened for cancers early and get treated. This can save lives and reduce costs for patients and Federal taxpayers. “I am proud to be one of this bill’s 300 bipartisan cosponsors. “Another bill being considered today is the Ensuring Patient Access to Critical Breakthrough Products Act, which will ensure seniors have timely access to innovative medical technologies. “Many medical devices currently fall into what is known as the ‘valley of death.’ “This refers to the period between FDA approval of a device and when Medicare covers this technology. During the first Trump Administration, this led to CMS issuing a proposed rule in 2020 titled Medicare Coverage of Innovative Technology (or MCIT). “This pathway would have provided FDA-approved breakthrough medical devices four years of Medicare coverage while working on a longer term coverage determination. “The goal was to accelerate the benefits of these innovative technologies to benefit patients quicker. “This rule was repealed in 2021 by the Biden Administration and was replaced with the Transitional Coverage for Emerging Technologies (or TCET) pathway. “They cited the repeal was due to it having ‘unknown or unexpected risks’ for Medicare beneficiaries, which compared to MCIT, had many more regulatory hurdles and barriers for devices to come to market and is limited to only five new breakthrough technologies each year. “Getting this bill signed into law will bring us back closer to the original MCIT rule, spurring more innovation in the medical device and enhancing seniors timely access to medical innovations. “I personally am frustrated with CMS acting more as a scientific regulatory agency than an agency focused on reimbursing for FDA approved products. FDA is the scientific regulatory agency. “I am sure everyone here has heard complaints about the opaque and slow-moving National Coverage Determination process at CMS or had frustrations with Local Coverage Determinations. “One of the bills in front of us today will bring more transparency and accountability at CMS into both these coverage determination processes. “The final bill being considered today is H.R. 3826, the Expanding Access to Diabetes Self-Management Training Act by Representatives Schrier and Bilirakis. “This bill expands access to Diabetes Self-Management Training. This training is critical for individuals living with diabetes since it will help them cope, manage, and learn best practices when dealing with their diabetes. This bill will help increase the amount of educational opportunities for diabetes wellness training, lower costs for patients, and provide more access to certain services. “All of these bills before us today are important to bring more care to patients and achieve better health outcomes overall. “I am excited to hear from our expert panelists today to learn more about these bills and the importance of them.”

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. – 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. — In a new letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, House Energy and Commerce Committee Republicans requested an investigation into the strength, quality, and types of evidence-based scientific and pediatric medical literature relied on by the department to promote gender transition procedures for children.  KEY LETTER EXCERPT:  “As the agency responsible for safeguarding the health and well-being of Americans, all of HHS’s medical treatment recommendations, especially medical treatment recommendations for children, should be based on rigorous and well-established research, such as randomized controlled trials, that have definitively illustrated the long-term benefits of gender affirming care treatments.”  BACKGROUND:  Under the Biden administration, HHS has advocated for sex reassignment procedures on minors, including the use of serum puberty blockers, which have historically been used to treat children with precocious puberty (i.e., early onset puberty affecting about one percent of U.S. children) and sex offenders.   Puberty blockers, however, are known to stunt normal childhood development in children unaffected by precocious puberty.  HHS officials contend that sex reassignment procedures on minors are an unanimously accepted medical practice.  HHS Secretary Becerra testified before Congress that “every major medical association,” “medical journals,” and “scientific and medical evidence” has demonstrated the benefits of transitioning children’s biological sex.  When asked, via a Freedom of Information Act request, for the underlying scientific or medical basis for its position, HHS was only able to produce a two-page brochure that was already publicly available.  In contrast to HHS, a growing body of literature from medical experts and authorities around the world, including those in Europe, caution against performing such procedures on minors.   Courts and government health agencies responsible for determining child welfare have sought to limit child sex reassignment procedures.   Other countries have banned these interventions and surgeries on minors altogether.  An article published in the British Journal of Medicine found “there is great uncertainty about the effects of puberty blockers, cross-sex hormones, and surgeries in young people.”   A court in the United Kingdom noted the obvious about administering puberty blocking chemicals onto children: “[i]t is highly unlikely that a child aged 13 or under would be competent to give consent to the administration of puberty blockers. It is doubtful that a child aged 14 or 15 could understand and weigh the long-term risks and consequences of the administration of puberty blockers.”  In April 2024, the Cass Review , an independent review of gender identity services for children and young people, commissioned by the National Health Service England, found “[w]hile a considerable amount of research has been published in this field, systematic evidence reviews demonstrated the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.”   The Cass Review also found that “[t]he rationale for early puberty suppression remains unclear, with weak evidence regarding the impact on gender dysphoria, mental or psychosocial health,” as well as unknown effects on cognitive and psychosexual development.  In August 2024, the American Society of Plastic Surgeons (ASPS) became the first major U.S. medical association to express caution on the use of gender surgery for gender dysphoria in adolescents. In its formal statement, the association stated: “ASPS currently understands that there is considerable uncertainty as to the long-term efficacy for the use of chest and genital surgical interventions for the treatment of adolescents with gender dysphoria, and the existing evidence base is viewed as low quality/low certainty. This patient population requires specific considerations.”   The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), Rep. Dan Crenshaw (R-TX), Rep. Gus Bilirakis (R-FL), Rep. Buddy Carter (R-GA), Rep. Gary Palmer (R-AL), Rep. Neal Dunn (R-FL), Rep. Randy Weber (R-TX), Rep. Troy Balderson (R-OH), Rep. August Pfluger (R-TX), Rep. Diana Harshbarger (R-TN), and Rep. Kat Cammack (R-FL).  CLICK HERE to read the letter.

House Republicans scrutinize government grant funding recipients that fail to protect individuals from antisemitism Washington, D.C. — In a new letter to J. David Gladstone Institutes President Dr. Deepak Srivastava, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) have requested information about ongoing and pervasive acts of antisemitic harassment and intimidation at Gladstone and its leadership’s insufficient response to these acts. The letter is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY LETTER EXCERPTS: “The Gladstone Institutes, an independent biomedical research organization, claims that it takes an active stance against serious issues like discrimination and harassment and aims to ‘ensure all community members at Gladstone feel included’ and that the Institutes will aim to ‘implement accountability measures and reinforce Gladstone’s commitment to having an environment free of harassment.’ However, these values do not seem to be reflected in the actions of leadership in response to recent concerns of antisemitic harassment and discrimination within the Institutes.” [...] “The reports of antisemitic harassment at Gladstone coupled with the inadequate response by leadership is concerning to the Committees. Failing to act decisively to ensure a safe environment for all trainees, faculty, and staff is a grave dereliction of your responsibilities as President of Gladstone.” “Failing to comply with basic safety protections for members of Gladstone or failure to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university. Congress has an obligation to exercise oversight of recipients of federal funds when blatant and ongoing Title VI violations appear to be happening. If Congress determines an institution of higher education/research is blatantly ignoring its legal responsibilities, we may consider rescinding research and development funds previously appropriated.” BACKGROUND ON TAXPAYER FUNDING: Gladstone received more than $41 million in funding from the NIH in Fiscal Year 2023, not including potential taxpayer funding that individual faculty may have received through their affiliation with the University of California, San Francisco (UCSF) or any other affiliated universities.   According to the NIH’s Grant Policy Statement, any institution receiving federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  Institutions receiving federal taxpayer financial assistance—such as NIH grants—are prohibited from discriminating based on a variety of categories, including national origin.   These laws also protect members of the institution who are or are perceived to be members of a group with shared ancestry, such as students/trainees of Jewish heritage. BACKGROUND ON INSTANCES OF ANTISEMITISM : Two days after the October 7, 2023, Hamas terrorist attack, a graduate student working in a lab within Gladstone sent an antisemitic email to all Gladstone faculty, trainees, and staff falsely stating that the attack on innocent Israeli civilians was “the resistance in Gaza launch[ing] a surprise attack against Israel, taking occupation soldiers hostage, taking over Israeli military vehicles, and gain[ing] control over illegal Israeli settlements.”  The email goes on to claim that all casualties resulting from Palestinian actions are the responsibility of Israel.  Immediately following this mass email, members of the Gladstone faculty began contacting the Gladstone Institutes’ President and other leadership, appalled by the language of the email, concerned for their safety and worried that the email could be seen as an incitement to violence.  Jewish members of the Institutes also expressed their deep, personal pain following the Hamas attack, as some members had family or friends reported killed or missing directly after the attack.  These fears—including fears of being attacked in the lab by the author of this cruel and antagonistic email—were shared directly with President Srivastava.  Despite this, Gladstone leadership did not issue a public statement or position against antisemitism to quell fears of Jewish faculty and trainees.  In May 2024, the Center for Combatting Antisemitism sent President Srivastava a letter requesting administrative action to address the hostile environment and disparate treatment of Jewish members at Gladstone.  This letter noted that Gladstone refused to acknowledge Jewish American Heritage Month, Passover, or Holocaust Remembrance Day, despite sending official celebratory emails and holding events for other religious, ethnic, or national holidays, including Black History Month, International Women’s Day, and Ramadan.  The Center followed up with Gladstone several times, but never received a response.  Jewish faculty and trainees have conveyed to leadership within Gladstone instances of antisemitic harassment and discrimination, which faculty and trainees believe were not taken seriously, making some feel uneasy about speaking out.  For example, per a publicly available Fair Employment and Housing Act complaint to the California Civil Rights Division, a Jewish faculty member openly discussed fellow faculty using racial stereotypes, including comments about a “Jewish nose.”  When these comments were brought to human resources, no investigation occurred.  Instead, the complainant was subsequently targeted with an investigation ultimately deemed to be unwarranted.  Then, following the complainant’s post-October 7th advocacy on behalf of Jewish faculty and trainees, the complainant was threatened repeatedly with career-ending termination, allegedly in an attempt to extort a resignation.  When the threats did not have their desired effect, Gladstone placed the complainant on administrative leave and removed the complainant’s electronic access to email and files but also physical access to the complainant’s lab, removing all ability to conduct work on an NIH-funded grant.  Gladstone ultimately paid an undisclosed sum to settle the matter and avoid litigation.  To elevate concerns regarding widespread, ongoing discrimination, Jewish faculty and trainees requested permission to bring in a speaker related to antisemitism.  Other minority groups had previously been given permission to bring in similar anti-racism speakers.  However, while leadership stated it would look into the idea, ultimately no speaker was brought, and no program was launched regarding antisemitism. BACKGROUND ON AFFILIATIONS WITH OTHER INSTITUTIONS UNDER INVESTIGATION : Gladstone Institutes is affiliated with other institutions under congressional investigation.  For example, Gladstone is an affiliate of the UCSF, which is undergoing congressional investigation for reports of antisemitism within the university, medical school, and medical centers.  Most of Gladstone’s principal investigators are also faculty at UCSF, and the Institutes provide research positions and opportunities for graduate students from UCSF.  Moreover, there is a joint institute—the Gladstone-UCSF Institute of Genomic Immunology—further linking the two institutions.  Gladstone is also affiliated with the University of California, Berkeley and Stanford University, both of which are also under investigation for concerns related to antisemitism. CLICK HERE to read the full letter.