Subcommittees

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.  – Congressman Richard Hudson (NC-09), Chairman of the Subcommittee on Communications and Technology, delivered the following opening statement at today’s hearing titled Examining Solutions to Expedite Broadband Permitting . Subcommittee Chairman Hudson’s opening statement as prepared for delivery:  “Closing the digital divide has long been a bipartisan priority for this subcommittee. Under both Republican and Democratic majorities, we have discussed and found ways to ensure that every American has access to high-speed broadband. Today, we have the opportunity to achieve this goal with the $42 billion Broadband Equity, Access, and Deployment (BEAD) program.   “I think members of both parties would agree that BEAD has not gone as we had hoped. After almost four years, not a single home has been connected. Some in my party want to completely scrap BEAD and start over because of how the previous Administration ran the program. But that is not my view. My goal has been to fix the program so that we can deploy broadband quickly. The name of my bill, the SPEED for BEAD Act, reflects this.    “I am pleased that many of my proposed reforms have been adopted by the Trump Administration and that they are working quickly to review and approve state proposals.    “Still, money alone will not close the digital divide. Burdensome, opaque, and expensive permitting reviews that exist at every level of government continue to prevent or delay deployment. I have heard this from broadband providers across the country.   “In my home state of North Carolina, one provider has waited over a year for the Department of the Interior to review its application to build on federal land—even though the agency is required to provide a response within 270 days.    “Another North Carolina provider’s project was delayed because it has to do a historic preservation review despite the fact that it was on previously disturbed terrain that likely already had a review. And this is in addition to lengthy state and local application reviews that can include excessive costs unrelated to approving the permit.    “Unless we streamline the permitting process, all of the money we have dedicated to deployment will be tied up in burdensome reviews resulting in more unnecessary delays, forcing millions of Americans to continue to wait for connectivity.   “Energy and Commerce Committee Republicans are committed to reforming this process. For the past three Congresses, we have introduced a package of bills to address this problem. Each of these bills tackles an obstacle that has either prevented, delayed, or complicated deployment, with the goal of instilling certainty, predictability, and savings into this process.  “For example, my RAPID Act would exempt small cell wireless antennas from burdensome and expensive environmental and historic preservation reviews, as well as reform the Tribal notification process to expedite wireless broadband deployment. I look forward to the discussion today to find the best path forward together.  “Some of these bills passed the House last Congress with bipartisan support. I hope we can pass those bills, as well as the others, into law this Congress. Enacting this package will make deploying broadband cheaper, more predictable, and less burdensome, ultimately connecting more Americans.  “I want to acknowledge our partners at the Federal Communications Commission for their work on this issue. Under then-Chairman Ajit Pai, the FCC used its authorities to remove state and local obstacles to deployment, implement shot clocks, and cap fees where they can. That work is continuing under Chairman Brendan Carr, as they will seek comment later this month on additional proposals. We are grateful for this work and, through these bills, hope to codify and build on what they have done.  “I hope that instead of playing the blame game today, we can focus on making sure every American has access to the broadband service that is essential to life in the 21st Century. We have an esteemed panel of witnesses with us today, all of whom have experience with the challenges of deploying broadband. I look forward to hearing from them and I look forward to this discussion.”  ###