Blog | 7/25/2025

Trump Administration Healthcare News: July 25, 2025

Health Advances weekly healthcare tracker focused on top level government administration news.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on July 25, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

The Trump Administration’s Foreign Aid Review: Status of U.S. Global Maternal and Child Health Efforts

  • The administration’s FY 2026 budget request includes significant reductions in funding for global health, and does not include funding for bilateral maternal and child health efforts.
  • Final appropriation amounts for FY 2026 will be determined by Congress.
  • The administration also submitted its first rescission package to Congress, including proposed rescissions of more than $1 billion in FY 2025 funding for global health. Congress voted to amend the package, reducing that amount to $500 million and exempting some program areas, including maternal and child health, from the rescission.
  • The U.S. government has been involved in supporting global maternal and child health (MCH) efforts for more than 50 years, helping to contribute to worldwide success in reducing maternal and child mortality.
  • The FY 2025 Continuing Resolution that passed in March included level funding for bilateral MCH activities at USAID and CDC of $845 million (and level funding for multilateral contributions to Gavi and UNICEF).
  • The U.S. has been the top donor government to MCH activities in the world.
  • Press: https://www.science.org/content/article/trump-s-plan-slash-global-health-spending-rejected-key-spending-panel
  • Analysis: https://www.kff.org/global-health-policy/fact-sheet/the-trump-administrations-foreign-aid-review-status-of-u-s-global-maternal-and-child-health-efforts/

KEY FEDERAL GOVERNMENT NEWS

Allocating CBO’s Estimates of Federal Medicaid Spending Reductions Across the States: Enacted Reconciliation Package

  • On July 4, President Trump signed into law a budget reconciliation package once called the “One Big, Beautiful Bill” that made major reductions in federal health care spending to offset part of the costs of extending expiring tax cuts.
  • The Congressional Budget Office’s (CBO) latest cost estimate shows that the reconciliation package would reduce federal Medicaid spending over a decade by an estimated $911 billion (after accounting for interactions that produce overlapping reductions across different provisions of the law) and increase the number of uninsured people by 10 million.
  • Building on prior KFF analysis of the House-passed reconciliation bill, this analysis allocates CBO’s federal spending reductions in the enacted reconciliation package across the states.
  • Analysis: https://www.kff.org/medicaid/issue-brief/allocating-cbos-estimates-of-federal-medicaid-spending-reductions-across-the-states-enacted-reconciliation-package/
  • CBO Report: https://www.cbo.gov/publication/61570

Trump administration asks Supreme Court to allow NIH to cancel health grants

  • The Trump administration asked the Supreme Court on Thursday to allow it to continue moving forward with canceling National Institutes of Health (NIH) grants over their connections to diversity initiatives.
  • The Department of Justice (DOJ) asked the court for an emergency stay that would stop Boston-based U.S. District Judge William Young’s ruling last month, which halted the cancellation and forced the government to reinstate several of the grants.
  • The case centered on a legal challenge by researchers, unions and a coalition of 16 Democratic-led states. They sued the administration after the NIH terminated grants supporting research on topics such as health equity, racial disparities, vaccine hesitancy and maternal health in minority communities.
  • https://thehill.com/policy/healthcare/5419201-trump-nih-grants-supreme-court/

Proposal to Expand Private Health Care for Veterans Advanced by House Panel

  • A bill aimed at giving veterans easier access to private doctors using Department of Veterans Affairs funding has advanced out of a key House panel after stark partisan debate.
  • Cost issues scuttled a couple of controversial provisions from the GOP-led bill advanced Wednesday compared to the version of the bill that was introduced earlier this year.
  • The three-year pilot program would allow veterans to get private outpatient mental health and substance abuse treatment without a referral or pre-authorization. The pilot would be available in at least five locations.
  • https://www.military.com/daily-news/2025/07/23/proposal-expand-private-health-care-veterans-advanced-house-panel.html

HHS Targets Transplant System Amid Reports of Donors Showing 'Signs of Life'

  • HHS on Monday announced "a major initiative to begin reforming the organ transplant system" after an investigation by the Health Resources and Services Administration (HRSA) found "disturbing practices" by Kentucky Organ Donor Affiliates (KYDA), an organ procurement organization serving Kentucky, southwest Ohio, and parts of West Virginia.
  • "Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying," HHS Secretary Robert F. Kennedy Jr. said in the release. "The organ procurement organizations (OPOs) that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor's life is treated with the sanctity it deserves."
  • The HHS announcement came the day before Tuesday's hearing held by the House Energy & Commerce Subcommittee on Oversight and Investigations to discuss oversight of the organ procurement and transplant system.
  • Press: https://www.medpagetoday.com/transplantation/transplantation/116620 (subscription required for full text)  
  • HHS Press: https://www.hhs.gov/press-room/hrsa-to-reform-organ-transplant-system.html

Executive Order: Ending Crime and Disorder on America’s Streets [impacts Mental Health]

  • Directs federal agencies to support the expanded use of civil commitment and institutional treatment for homeless individuals with serious mental illness or substance use disorders, while conditioning federal grants on the enforcement of anti-vagrancy laws and restricting funding for programs that permit drug use or prioritize housing without treatment.
  • Federal agencies must promote the expanded use of civil commitment for homeless individuals with serious mental illness or substance use disorders, including by seeking the reversal of judicial precedents and termination of consent decrees that obstruct institutionalization.
  • This order conditions federal grant funding on local enforcement of anti-vagrancy laws, such as bans on public drug use, camping, and squatting, and prohibits support for programs that emphasize housing without requiring treatment or accountability. The order also expands support for drug and mental health courts, permits more restrictive housing rules, and authorizes the collection and sharing of health data with law enforcement to enhance public safety.
  • Analysis: https://www.akingump.com/en/insights/blogs/trump-executive-order-tracker/ending-crime-and-disorder-on-americas-streets
  • Executive Order: https://www.whitehouse.gov/presidential-actions/2025/07/ending-crime-and-disorder-on-americas-streets

KEY LAWSUITS

Anti-vaccine group that Robert F. Kennedy Jr. founded files lawsuit against him over vaccine safety task force

  • A nonprofit anti-vaccine group founded by Robert F. Kennedy Jr. is suing him, in his capacity as secretary of the US Department of Health and Human Services, for failing to establish a task force to promote the development of safer childhood vaccines.
  • “Our first priority will ALWAYS be children’s health. Sec. Kennedy has FAILED ‘to establish a task force dedicated to making childhood vaccines safer, as mandated by federal law,’ so we WILL be holding him accountable,” Children’s Health Defense said Tuesday in a post on X.
  • The National Childhood Vaccine Injury Act of 1986 directs the HHS secretary to establish a task force consisting of the director of the National Institutes of Health, the commissioner of the Food and Drug Administration and the director of the Centers for Disease Control and Prevention. The NIH director is designated as chair.
  • Children’s Health Defense says attorney Ray Flores, its senior outside counsel, filed the lawsuit on its behalf. Kennedy filed a similar suit in 2018 after a Freedom of Information Act request failed to produce any of the reports that are supposed to be filed under the Act, including the 1998 report.
  • HHS has not responded to CNN’s request for comment about the new lawsuit.
  • https://www.cnn.com/2025/07/22/health/kennedy-vaccine-hhs-lawsuit

Humana refiles Medicare Advantage ratings lawsuit against federal government

  • Humana refiled a lawsuit Monday evening against the federal government, as the health insurance giant pushes to keep billions of dollars that could vanish as a result of downgraded ratings tied to its Medicare Advantage plans.
  • A federal judge last Friday tossed out Humana’s original lawsuit that alleged the government didn’t follow its own rules when grading the quality and customer service of Humana’s 2025 Medicare Advantage policies. The judge dismissed the case on procedural grounds, saying Humana filed the lawsuit before it finished its appeal with Medicare officials.
  • The Centers for Medicare and Medicaid Services, the federal agency that regulates Medicare Advantage plans, shot down Humana’s appeal in April, which Humana’s lawyers said justified the revised lawsuit.
  • https://www.statnews.com/2025/07/22/humana-cms-medicare-advantage-ratings-lawsuit-refiles/  (subscription required for full text)      

KEY BIOPHARMA NEWS

FDA adds information on Commissioner’s National Priority Voucher program

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry

  • The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.”
  • This final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
  • This final guidance for industry revises and replaces the draft guidance of the same name issued in August 2023.
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry

HHS approves flu vaccines without thimerosal, manufacturers expect no disruptions

  • The U.S. Department of Health and Human Services (HHS) adopted a recommendation from vaccine advisers to remove thimerosal from all influenza vaccines used in the U.S., despite studies that show the preservative is safe. 
  • HHS Secretary Robert F. Kennedy Jr. approved the recommendation of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), which voted last month in favor of using only single-dose influenza vaccines without thimerosal. 
  • Manufacturers said the ruling should not affect their ability to provide vaccines this year. HHS also said manufacturers have confirmed they have capacity to ensure supplies for the Vaccines for Children program and adults remain uninterrupted. 
  • Press: https://publications.aap.org/aapnews/news/32711/HHS-approves-flu-vaccines-without-thimerosal
  • HHS Press: https://www.hhs.gov/press-room/thimerosal-mercury-removed-from-us-flu-vaccines-acip.html

FDA names next CDER director in biotech vet George Tidmarsh

  • FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.
  • Tidmarsh takes over the CDER after a lengthy career in biotech and academia that saw the development of seven FDA-approved drugs, the formation of several biopharma companies and the establishment of Stanford University’s Master of Translational Research and Applied Medicine program.
  • Some of the biopharma companies Tidmarsh had a hand in founding and leading include Metronome Therapeutics, Revelation Biosciences and Horizon Therapeutics, which has since been picked up by Amgen for $27.8 billion. He’s been stationed at his alma mater at Stanford University’s School of Medicine for the last 15 years, most recently serving as an adjunct professor of pediatrics and neonatology.
  • https://www.fiercepharma.com/pharma/fda-names-next-cder-director-biotech-vet-george-tidmarsh

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Lab Compliance: Companion Diagnostic Testing Arrangement Approved by HHS Office of Inspector General

  • The Proposed Arrangement
    • The Requestor manufactures an FDA-approved medication with three indications for a particular condition. As part of the proposed Arrangement, the Requestor offers a free next-generation sequencing-based in vitro diagnostic test to screen for patients with the condition that have a particular type of deficiency. The test is useful only for the purposes of determining whether the Requestor’s medication or a competitor product would be an appropriate treatment for the patient.
  • The Agency’s Analysis
    • Anti-Kickback Statute:  According to HHS-OIG, the Arrangement results in remuneration to both eligible patients and their physicians, thereby implicating the Anti-Kickback Statute (AKS). With respect to patients, HHS-OIG noted that free testing has value because patients would have to pay associated cost sharing for the test.
    • Civil Monetary Penalty Statute: HHS-OIG also found that the Arrangement implicates the beneficiary inducement prohibition under the Civil Monetary Penalty Statute (CMP)
  • Given the scientific advances in personalized medicine and specialty lab tests, including FDA-approved companion diagnostics, labs and manufacturers may be increasingly interested in sponsored testing Arrangements to support patient access.
  • Analysis: https://www.sidley.com/en/insights/newsupdates/2025/07/lab-compliance-pharmaceutical-manufacturer-sponsored-companion-diagnostic-testing-arrangement
  • HHS Advisory Opinion: https://oig.hhs.gov/compliance/advisory-opinions/25-07/

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

KEY MEDTECH NEWS

Trump gives device sterilizers two more years to comply with EtO limits

KEY ACRONYMS

  • ACIP = Advisory Committee on Immunization Practices
  • AKS = Anti-Kickback Statute
  • BsUFA = Biosimilar User Fee Act
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMP = Civil Monetary Penalty Statute
  • CMS = Center for Medicare & Medicaid Services
  • CNPV = Commissioner's National Priority Vouchers
  • DOJ = Department of Justice
  • EO = Executive Order
  • EPA = Environmental Protection Agency
  • EtO = ethylene oxide
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • HHS-OIG = Department of Health and Human Services Office of Inspector General
  • HRSA = Health Resources and Services Administration
  • NIH = National Institutes of Health
  • KYDA = Kentucky Organ Donor Affiliates
  • MCH = maternal and child health
  • OPOs = organ procurement organizations
  • UNICEF = United Nations Children's Fund
  • USAID = U.S. Agency for International Development

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