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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. ###

WASHINGTON, D.C.  – In President Trump’s historic Working Families Tax Cuts, House Republicans implemented provisions that protect our federal health care programs for the traditional Medicaid population—our expectant mothers, their children, low-income seniors, and individuals with disabilities. FACT: The enactment of the Working Families Tax Cuts emphasized the need for and importance of guardrails to stabilize and strengthen the Medicaid program for the vulnerable Americans it was designed to serve and assist for generations to come. Republicans remain adamantly opposed to Democrat policies that allow illegal immigrants, able-bodied adults choosing not to work, and people who aren’t actually qualified for Medicaid (or at times people who are dead or enrolled in two state programs at the same time) to continue consuming resources from a rapidly growing system. The Republican solution invests billions into long-term care for our seniors and people with disabilities by establishing a new pathway for states to offer home and community-based services to more people who are in need. The new investment will lead to an increase in tens of billions of new dollars in long-term care spending, while also diverting and delaying the eventual need for more expensive, acute care. Democrats’ continued efforts to mislead Americans through false claims that the traditional Medicaid population will lose their care because of this bill are simply not true. Nothing in the Working Families Tax Cuts law would change benefits for pregnant women, children, seniors, or individuals who are disabled. Instead, the bill included numerous commonsense provisions that reduce abuse in the program and allow Medicaid resources to help uplift the traditional Medicaid population and ensure Medicaid remains a safety net for generations to come. “Time and again, Republicans have fought for strengthening, sustaining, and securing the Medicaid program for our most vulnerable Americans—expectant mothers, children, low-income seniors, and individuals living with disabilities,” said House Committee on Energy and Commerce Chairman Brett Guthrie . “No matter how many times we emphasize the point, the truth of the Working Families Tax Cuts law stays the same: despite the claim of left-wing media, members of the traditional Medicaid population will not lose coverage due to this law. Republicans are enabling the Medicaid program to serve its intended purpose, and we will continue to fight for solutions that protect the program for generations to come.” “House Republicans advanced a legislative product that lowers health care premiums, promotes community engagement and delivers fairness and accountability to our health care system. The Working Families Tax Cuts increases oversight efforts as part of a larger package of Medicaid program integrity measures to more precisely serve the traditional Medicaid and the Medicaid Expansion populations,” said Health Subcommittee Chairman Morgan Griffith . “Progressive Democrats and their Congressional allies are desperate as they try to pan the Working Families Tax Cuts as devastating to the traditional Medicaid population, which is not true! The traditional Medicaid population, which includes expectant mothers, low-income seniors, children and individuals with disabilities, is not affected by our bill!” “AFP proudly supported the Working Families Tax Cut Act, and we’ll defend it to our dying day. With this landmark law, Republicans averted the biggest tax hike in American history, secured the border, and unleashed America’s energy abundance, and delivered on some of the most important, pro-patient health care reforms in a generation. We especially applaud Republicans for disregarding Democrats’ hyperbolic claims and histrionic scare tactics aimed at blocking any change to Medicaid, a vital part of our nation’s health care safety net. Years of Democratic neglect and profligacy have allowed Medicaid to become swollen with waste, fraud, and abuse, including billions in ‘free’ health care for illegal immigrants. Republicans have come to the rescue, preserving Medicaid for low-income, disabled, and other vulnerable Americans—refocusing it on those who need it most. And they did it without cutting benefits in any way. We also applaud the new law because it boldly advances a Personal Option—affordable health care you can trust,” said Senior Health Policy Fellow at Americans for Prosperity, Dean Clancy. “Only a few months old, it’s already increasing the quality and accessibility of health care by expanding access to powerful tools like tax-free Health Savings Accounts and exciting new options like direct primary care, which gives patients affordable, round-the-clock access to the doctors they trust—without insurance company meddling. On behalf of our thousands of grassroots activists, we applaud President Trump and his fellow Republicans for taking the first big leap toward the affordable, personalized health care system Americans want and deserve.” “The Working Families Tax Cuts rightfully refocuses Medicaid on low-income children, pregnant women, the elderly, and the disabled. It does this by preserving federal health programs for citizens and lawful residents. It requires able-bodied, working-age adults to work, go to school, or volunteer to receive benefits. It cracks down on corporate-welfare schemes that direct billions of dollars to wealthy, politically connected insurers and hospitals. And it reduces waste, fraud, and abuse that divert resources from those that truly need it,” said President of Paragon Health Institute, Brian Blase, Ph.D. “As Director of Able Americans, I’m encouraged to see the Working Families Tax Cuts (WFTC) include two key provisions that will directly improve the lives of Americans with disabilities. “First, the WFTC incorporates the Helping Communities with Better Support (HCBS) Act, which expands access to Medicaid home- and community-based services for individuals with disabilities and their caregivers. This provision increases transparency and accountability for those waiting for care—an essential step toward dignity and choice. “Next, the bill strengthens ABLE Accounts by extending vital tax provisions that help people with disabilities save for their futures without fear of losing benefits like Medicaid. It codifies a $1,000 savers credit and allows families to roll over 529 education savings accounts into ABLE Accounts—promoting financial security, independence, and flexibility for those navigating work and long-term care needs. “Importantly, the WFTC protects the future of Medicaid for the most vulnerable it was intended to serve. WFTC adds critical protections against abuse of the program and adds a community engagement requirement for expansion-population, able-bodied adults. Those who are unable to work because of their disability or who are receiving medical care are not included in this requirement,” said Director of the National Center’s Able Americans Program, Rachel K. Barkley. What Republicans Did Under the Working Families Tax Cuts: The law made historic investments for the most vulnerable.   Through the $50 billion dollar investment from the Rural Health Transformation Program, states have the opportunity to bolster their ability to care for the vulnerable by:   Helping maintain essential services like emergency room care, labor and delivery services, and behavioral health care;   Funding rural emergency medical services (EMS) and support training for new EMS personnel; and/or   Investing in technology infrastructure to help communities better access care, to name only a few examples.   The Working Families Tax Cuts law also implemented the largest ever investment in Home and Community Based Services, which are vital for members of the traditional population such as seniors and individuals who are disabled. Republicans reinstated States’ ability to conduct more frequent eligibility redeterminations for able-bodied adults.   This strengthens program integrity by requiring states to check eligibility every six months to ensure enrollees—particularly the able-bodied, working-age adult expansion category—are unable to take advantage of a system that was created to protect our most vulnerable.   This law also takes action to prohibit Medicaid from wasting money covering beneficiaries who have died, or the same individual enrolled in multiple states. WFTC cracked down on States’ capacity to provide Medicaid coverage to non-citizens.   States should not be granted more federal funding for providing care to non-citizens then they are for our pregnant women, their children, low-income seniors, and individuals with disabilities. The law increased personal accountability for able-bodied, unemployed adults within the expansion population to lift Americans out of poverty and re-enter society.  Establishing work requirements for able-bodied adults who are choosing not to work helps ensure that Medicaid is there to continue to support future generations of Americans most in need—our expectant mothers, low-income seniors, children, and individuals with disabilities. The Working Families Tax Cuts law set a $1 million limit on the home value people can keep when applying for Medicaid, ensuring help goes to those who truly need it.   The bill includes commonsense policies to ensure resources are focused on those who need it the most, not on people with million-dollar homes. The legislation reduced States’ reliance on gimmicks that shift costs of care for members of the expansion population onto the federal taxpayer, making sure states are paying their fair share.   States have been taking advantage of federal taxpayers to inflate their Medicaid programs, especially in expanding care for able-bodied adults. Our legislation holds state accountable. CLICK HERE to read the Fox News article, Republicans, health experts push back on Democrats’ Medicaid ‘scare tactics’ ###

WASHINGTON, D.C.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to an announcement by the Department of Health and Human Services (HHS) of a decision to recall ByHeart Whole Nutrition Infant Formula due to an outbreak of infant botulism, which is currently being investigated. “The Committee has a history of conducting oversight of infant formula matters to ensure adequate supply is safe and readily available for families and children. President Trump’s FDA has also done important work through Operation Stork Speed to address these issues, and I am pleased to see his Administration take swift action to restore confidence for caretakers when it comes to their little ones’ nutritional needs,” said Chairman Guthrie . “I am grateful to HHS Secretary Kennedy and FDA Commissioner Makary for furthering our commitment to protecting children and mothers through improving the safety and availability of the domestic infant formula supply.”   Background:    The Committee has conducted extensive oversight of the Biden Administration’s mishandling of the infant-formula shortage and challenged the U.S. Food & Drug Administration (FDA) on its preparedness, inspection practices, and responsiveness to early warnings about the formula crisis.  On May 25, 2022, the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing titled “Formula Safety and Supply: Protecting the Health of America’s Babies” during the infant-formula shortage to examine supply, safety, and what further action was needed.  Following the hearing, the Committee sent a letter to then FDA Commissioner, Robert M. Califf, directing the Biden Administration to provide access to the memos and reports sent to the White House and demanding that the administration be completely transparent with parents who deserve answers.   On September 21, 2022, Energy and Commerce Republicans convinced Committee Democrats to join in passing a bipartisan resolution  requesting that the Biden administration turn over documents related to the baby formula shortage. H.Res.1287 was reported out of the committee by a vote of 54-0.    Chairman Guthrie has also introduced legislation to help prevent future baby formula shortages—the More Options for Infants and Parents Act— and signed on as a cosponsor to the Improving Newborn Formula Access for a Nutritious Tomorrow (INFANT) Act , to enhance testing of infant formula for contaminants and improve resilience of supply. ###

WASHINGTON, D.C. – In case you missed it, Breitbart recently featured Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, who shared ways in which Republicans have already voted to lower health care premiums that Democrats opposed in the Working Families Tax Cuts. In Case You Missed It: “House Energy and Commerce Committee Chairman Brett Guthrie (R-KY) and Health Subcommittee Chairman Rep. Morgan Griffith (R-VA) told Breitbart News that Republican proposals would have lowered health insurance premiums by nearly double compared to the Biden-era enhanced Obamacare credits. “What we’ve heard from both sides of the aisle is that Obamacare is not affordable. But what we’ve not heard is Democrats acknowledge the waste, fraud, and abuse that’s been enabled by these temporary subsidies — including massive handouts to big health insurance companies and expanded taxpayer subsidies to the wealthiest Obamacare enrollees,’ Guthrie told Breitbart News in a written statement. “Congressional Democrats’ demands to open the government are partly based on the premise that affordable health care is out of reach for many Americans. What Democrats now want as part of $1.5 trillion in additional federal spending is a permanent and everlasting program that they designated to expire in 2025,’ Griffith told Breitbart News. “The congressmen spoke to Breitbart News as the Democrat shutdown has continued for more than a month. Democrats shut down the government over expiring Biden-era enhanced Affordable Care Act (ACA), or Obamacare, credits. Democrats first enhanced the Obamacare credits through the Biden coronavirus stimulus plan, the $1.9 trillion American Rescue Plan. The Democrat party then continued the credits with the passage of the so-called Inflation Reduction Act until the end of 2025, where Guthrie says they spent most of the month refusing to work with Republicans on meaningful solutions to lower healthcare costs. “With the Democrat-designed sunset date of December 31 for these COVID-era subsidies, we could have been utilizing this month to continue finding more tangible, meaningful solutions to make health care more affordable for Americans. Instead, Democrats chose to hold the American people hostage over billion-dollar handouts to big insurance companies,’ the Energy and Commerce Committee chairman continued. “Democrats initially created the temporary COVID-19 era ‘enhanced’ premium tax credits to help people who struggled from the economic fallout of the pandemic. But now, Democrats are doubling down on the temporary ‘enhanced’ credits as a means to subsidize Obamacare,’ Griffith said. “He added, ‘Whether intended or not, this is a stunning admission that President Obama’s signature healthcare program, Obamacare, has failed to provide affordable health care to the American people. Issues to soften the impacts of the Democratic Party’s failed policies can be discussed if we get the government open again.’ “Republicans such as Guthrie have criticized the Obamacare enhanced credits, more formally known as the Enhanced Premium Tax Credit (EPTC), because they are essentially direct payments to health insurers to lower healthcare costs. “While Democrats such as House Minority Leader Hakeem Jeffries have accused Republicans of not wanting to provide health care to ‘everyday Americans,’ Democrats moved to nix substantial reform that would have drastically lowered health insurance premiums while the Big Beautiful Bill worked its way through the Senate. “In June, Democrats lobbied the Senate parliamentarian to scrap the ACA cost-sharing reduction payments (CSRs) from the Big Beautiful Bill, saying that it violates the Byrd Rule and thus requires 60 votes to be included in Trump’s Big Beautiful Bill. Funding CSRs would lower benchmark silver premiums used to set subsidy amounts. CSR payments are a type of financial assistance that would help lower out-of-pocket costs for eligible individuals and families that enroll in a Silver Obamacare plan. “The Congressional Budget Office (CBO) found that these healthcare reforms would have lowered healthcare premiums by 12.7 percent and reduced costs by decreasing the need for Obamacare EPTCs CSR. CSR would have lowered costs by $30.8 billion. “Andy Slavitt, President Barack Obama’s Centers for Medicare & Medicaid Services (CMS) administrator, in 2017 said that CSR payments would drastically reduce health insurance premiums: “Democrats have not once approached me, or my staff, to find a path forward. Republicans, time and again, have voted for policies that lower healthcare premiums by nearly double what extending Democrats’ temporary COVID Credits would. Democrats unanimously opposed these commonsense policies and actively worked to undermine our efforts to lower premiums for the 7 percent of Americans who choose to enroll in an Obamacare plan. We stand ready to work across the aisle to advance real solutions that address the root causes impacting health care affordability,’ Guthrie continued. “The Biden-era enhanced Obamacare credits were meant to alleviate the costs of the pandemic and will soon expire. The generous nature of the subsidies gave some of the wealthiest Americans access to these benefits. This includes, according to the Energy and Commerce Committee: In North Carolina, an early retiree worth over $10 million qualified for over $17,000 in annual taxpayer subsidies for his Obamacare plan. Accountants in Texas were actively advertising how they were helping multi-millionaires get free or nearly free health insurance based on Democrats’ temporary COVID Credits. A family of four in Arizona making $600,000 a year, a married couple in West Virginia making $580,000, a single person in Vermont making $180,000 a year… taxpayers were suddenly subsidizing these people’s Obamacare plans thanks to the Democrats’ temporary COVID Credit policy. “The Paragon Health Institute estimated that annual Obamacare enrollment fraud could exceed $26 billion. The same think tank also found that the expiring Obamacare credits minimally impacted 2026 premiums, which counters a Democrat narrative that the expiration of those credits is responsible for health insurance price increases.” ###

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. – Today, Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, led a legislative hearing on examining policies to enhance seniors’ access to 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,” said Chairman Griffith. “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.” Watch the full hearing here . Below are key excerpts from today’s hearing: Congresswoman Diana Harshbarger (TN-01) on the bill To amend title XVIII of the Social Security Act to ensure transparency in the national coverage determination process under the Medicare program and to make certain adjustments to Medicare local coverage determinations: “My question is, how should Medicare prioritize coverage pathways for therapies that address these high burden diseases?” Dr. Brinton: “As I said, this is obviously a huge number of Medicare beneficiaries [that] suffer from cardiovascular disorders. Ultimately, as we mentioned before, transitional coverage—the [Transitional Coverage for Emerging Technologies] as we exist today—provides an opportunity, but it’s limited basically to five technologies. This is a pace that requires [Coverage with Evidence Development] to get to a national coverage decision, but there’s an opportunity for a lot more than that to broaden the capability. There are technologies that we need to have available to seniors. The opportunity to do that basically provides accelerating this process.”   Congressman John Joyce, M.D. (PA-13) on the Ensuring Patient Access to Critical Breakthrough Products Act of 2025: “Innovation has long been the cornerstone of American medicine. It’s how I practiced medicine for 25 years. America has consistently led the world in development of new and innovative therapies and cutting-edge medical devices. However, due to the current payment structure of Medicare, our nation’s seniors frequently can be excluded from accessing the newest medical device technology. In fact, this delay in coverage following an FDA approval by CMS has the unfortunate name of the valley of death.” Congresswoman Mariannette Miller-Meeks (IA-01) on the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act: “Late-stage cancer diagnoses are the deadliest, require treatments that take the hardest toll on patients, and cost the most to treat. That’s why I was proud to coauthor the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act with my colleagues Representatives Hudson, Arrington, Sewell, Ruiz, and Kelly. This critical legislation gives CMS the authority to cover multi-cancer early detection tests once they’re approved by the FDA, ensuring our nation’s seniors have access to groundbreaking innovation that will transform how we diagnose and prevent cancer progression.” ###

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.  – This week, the House Committee on Energy and Commerce is holding four Subcommittee Hearings and one Full Committee Markup. Read more below. SUBCOMMITTEE HEARING: The Energy and Commerce Subcommittee on Energy is holding a hearing to discuss building and appliance policies that could strengthen consumer choice, lower costs for American families, and make our electric grid more reliable. DATE: Tuesday, September 16, 2025  TIME: 10:15 AM ET  LOCATION: 2123 Rayburn House Office Building SUBCOMMITTEE HEARING: The Energy and Commerce Subcommittee on Environment is holding a hearing to discuss permitting reform under the Clean Air Act. DATE: Tuesday, September 16, 2025  TIME: 2:00 PM ET  LOCATION: 2123 Rayburn House Office Building FULL COMMITTEE MARKUP: The Committee on Energy and Commerce will hold a markup of seven bills. DATE: Wednesday, September 17, 2025  TIME: 10:00 AM ET  LOCATION: 2123 Rayburn House Office Building SUBCOMMITTEE HEARING: The Energy and Commerce Subcommittee on Heath is holding a hearing to discuss legislation that improves seniors’ access to cutting-edge health innovation. DATE: Thursday, September 18, 2025  TIME: 9:30 AM ET  LOCATION: 2123 Rayburn House Office Building SUBCOMMITTEE HEARING: The Energy and Commerce Subcommittee on Communications and Technology is holding a hearing to discuss permitting reform for enhanced connectivity. DATE: Thursday, September 18, 2025  TIME: 2:00 PM ET  LOCATION: 2123 Rayburn House Office Building  ###