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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  ###

WASHINGTON, D.C. – Yesterday, Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, led a markup of several public health reauthorization bills. “As we must do with every authorization bill that moves through this committee, it is critical that we evaluate the impacts these programs have had, and not only ensure the money is being spent as it was originally intended, but also ensure patient privacy is protected ,” said Chairman Griffith. “ Considering each of these reauthorizations is an important step forward to ensure each program is working as intended, and we will continue to examine these programs as we move to full committee .” Legislative Vote Summary: H.R. 4262 , To reauthorize programs related to health professions education, and for other purposes, was reported to the full committee by a voice vote. H.R. 3593 , Title VIII Nursing Workforce Reauthorization Act of 2025, was reported to the full committee by a voice vote. H.R. 2493 , Improving Care in Rural America Reauthorization Act of 2025, was reported to the full committee by a voice vote. H.R. 3419 , To amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs, was reported to the full committee by a voice vote. H.R. 3302 ,  Healthy Start Reauthorization Act of 2025, was reported to the full committee by a voice vote. H.R. 2846 , To amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries), was reported to the full committee by a voice vote. H.R. 4709 ,  Newborn Screening Saves Lives Reauthorization Act of 2025, was reported to the full committee by a voice vote Watch the full markup here . Below are key excerpts from today’s markup: Congressman Buddy Carter (GA-01) on the To amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs : “This bill reauthorizes the telehealth network and telehealth resource centers grant programs, administered by the Health Resources and Services Administration. These programs aim to improve access to telehealth services by providing technical assistance and other support methods to providers in rural and frontier communities, so patients in these areas can more easily access necessary telehealth services. Approximately 22,000 patients across the country have benefited from these programs. We must continue these vital resources to help improve health outcomes in underserved communities.” Chairman John Joyce (PA-13) on the Improving Care in Rural America Reauthorization Act of 2025: “The Improving Care in Rural America [Reauthorization Act] is legislation that accomplishes something that is so important for the constituents that don't have that access to screening, that don't have that access to care, and it is important that we reauthorize this. Representative Carter, in his legislation, understands that rural America is often left behind. This is a bipartisan piece of legislation that addresses that issue, that understands that we have a responsibility to all of our constituents, to all of America.”

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, announced a hearing titled Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies. “More than 68 million Americans rely on Medicare for life-saving treatments and critical care. Unfortunately, outdated coverage policies and bureaucratic hurdles can delay or leave seniors without access to the most innovative and effective treatments and services,”  said Congressmen Guthrie and Griffith.  “This hearing will examine policies to establish Medicare coverage of multi-cancer early detection tests, enhance transparency and accountability in the CMS coverage process, and cut red tape to ensure beneficiaries can access the latest breakthrough medical devices and technology.” Subcommittee on Health hearing titled Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies WHAT: Subcommittee on Health 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 This hearing will focus on the following bills:  H.R. 842 , Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (Rep. Arrington) H.R. ____ , [Ensuring Patient Access to Critical Breakthrough Products Act of 2025]  H.R. ____ , [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.]  H.R. 3826 , Expanding Access to Diabetes Self-Management Training Act of 2025 (Rep. Schrier) This notice is at the direction of the Chairman. This hearing will be open to the public and press and will be livestreamed at energycommerce.house.gov If you have any questions about this hearing, please contact Annabelle Huffman at Annabelle.Huffman@mail.house.gov . If you have any press related questions, please contact Katie West at Katie.West@mail.house.gov .

WASHINGTON, D.C.  – Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s health subcommittee markup of several public health reauthorization bills. Subcommittee Chairman Griffith's opening statement as prepared for delivery: “Today’s markup is a critical step to get these bills across the finish line before they expire at the end of this fiscal year. “The legislative hearing we held in July allowed us to hear from expert witnesses and understand the impact of some of these programs. “Two very important reauthorizations in front of us serve a vital role for our health care workforce, which are the Title VII and Title VIII reauthorizations. “H.R. 4262, the EMPOWER for Health Act, championed by Rep. Schakowsky from Illinois, reauthorizes the Title VII programs that help bolster our physician community by prioritizing recruitment and retention. “This will continue to incentivize more individuals to enter the health workforce and expand access to care in rural and underserved areas. “H.R. 3593, the Title VIII Nursing Workforce Reauthorization Act, being led by Rep. David Joyce from Ohio, reauthorizes Title VIII of the Public Health Service Act, which plays a meaningful role in supporting the development of our nation’s nurses. This reauthorization includes many important grant programs that help strengthen the nursing workforce and increase educational opportunities for both nurses and faculty at nursing schools. “The program also allows for loan repayment opportunities that are needed to incentivize more people to enter the nursing workforce. “We have all heard about the need for more health care workers in this country, and the reauthorization of these programs is a step in the right direction toward addressing that need. “Congress will continue to take a close look to ensure these taxpayer-funded programs are properly targeted and allocate resources to areas and patients who need it most. “We are also marking up H.R. 2493, the Improving Care in Rural America Reauthorization Act, an important bill carried by Rep. Carter of Georgia. This bill reauthorizes the Rural Health Services Outreach programs which aim to support and promote health care services in rural areas. “This program was signed into law in 2020 under President Trump’s first administration. It promotes innovative solutions that help people in rural communities get the care they need, such as increased access to preventative health services and screenings, chronic care management, and other forms of care that are needed in our rural areas across the United States. “Another important bill before us today is H.R. 3419, the Telehealth Network and Telehealth Resource Centers Grant Program Reauthorization Act, led by Rep. Valadao from California. This bill helps to increase education of the use of telehealth across the country. “Reauthorizing the Telehealth Resource Centers Grant Program will support our telehealth infrastructure that has become a lifeline for both providers and patients– especially in rural areas. These resource centers serve as the main hub for technical assistance and support for telehealth in their respective regions. “The University of Virginia is currently the resource center for my district and for the Mid-Atlantic region. They have experienced a 24 percent increase in telehealth visits from their program from FY24 to FY25. “This type of increase is happening across the country, and it is likely to continue growing. “As we look to extend telehealth flexibilities this year, we must reauthorize these centers to ensure our states are keeping up with the most recent technology and sharing their expertise so patients can have access to the care they need. “Other reauthorization bills that are before us, being led by Rep. Ocasio-Cortez from New York and Rep. Morrison from Minnesota, will help reduce the rate of infant mortality, improve perinatal outcomes, and expand access to screenings and services for newborns at risk for certain disorders. “Allowing for early newborn screening can save lives, create better outcomes, and reduce long term health care costs. “As we must do with every authorization bill that moves through this committee, we must evaluate the impacts these programs have had, and not only ensure the money is being spent as it was originally intended, but also ensure patient privacy is protected. “Considering each of these reauthorizations is an important step forward to ensure each program is working as intended, and we will continue to examine these programs as we move to full committee. “I look forward to moving these bills out of the health subcommittee.”

WASHINGTON, D.C.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Jason Smith (MO-08), Chairman of the House Committee on Ways and Means, issued the following joint statement in response to a newly released Government Accountability Office (GAO) report . The report articulates the need for greater transparency and reporting measures in order to improve the Centers for Medicare & Medicaid’s (CMS) National Coverage Determination (NCD) process for the approximately 68 million beneficiaries under its purview. “The GAO report makes clear that CMS must do more to provide transparency and accountability in its coverage decisions. Seniors should never be left waiting without clear answers about whether Medicare will cover the treatments and services their doctors recommend,” said Chairmen Guthrie and Smith . “Such clarity would also inspire confidence in American innovators to develop the next treatments and cures for patients. Greater openness in the National Coverage Determination process is essential to ensure trust, timely access to care, and confidence that decisions are being made fairly and consistently. We will continue exercising oversight to make sure CMS meets its responsibility to the more than 68 million Americans who rely on Medicare.”  Background:   In its report, GAO found that while CMS generally meets its specified time frames for the coverage determinations it considers, in cases where determinations are not yet considered, there is little to no explanation or specified timeline for when CMS will ultimately make a determination. This means that seniors and their health care providers and innovators are often left in the dark as to whether a particular medication or service is covered by Medicare, which may force patients to delay treatment until a coverage decision is granted by CMS. In a recent example, the Biden-Harris Administration’s CMS used a blanket NCD to restrict Medicare coverage for an entire class of Alzheimer’s treatments despite Food and Drug Administration approval for the same class of drug. The opaque nature of CMS’s current determination process leaves beneficiaries waiting, in some cases years, for access to a treatment or service their doctor has already deemed medically necessary. Highlights from the GAO Report :  CMS has not identified or assessed the causes of delays in coverage determinations.  Some coverage analyses exceeded timelines by as much as 351 days, including reviews of a cancer cell therapy and medical equipment for pain management.   CMS officials acknowledged they do not currently document analysis delays. The GAO report follows a 2023 letter submitted by the Energy and Commerce and Ways and Means Committees to the Biden-Harris Administration’s Health and Human Services Secretary and CMS Administrator, highlighting grave concerns with CMS’s coverage process and the need for timelier updates.  ###