
Blog | 6/6/2025
Trump Administration Healthcare News: June 6, 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 June 5, 2025. The details and broad themes may have changed.
KEY HEALTH NEWS (Global)
WH budget chief pressed on PEPFAR funds, says Africa ‘needs to absorb more of the burden’
- Office and Management Budget Director Russell Vought on Wednesday was pressed on proposed cuts to the President’s Emergency Plan for AIDS Relief (PEPFAR) pursued as part of a new rescissions request from the Trump administration.
- During a budget hearing Wednesday, Vought defended proposed reductions as targeting items like “teaching young children how to make environmentally friendly reproductive health decisions” and efforts he claimed were aimed at strengthening “the resilience of lesbian, gay, bisexual, transgender, intersex and queer global movements.”
- “There’s life saving treatment after you already have HIV, but there are prevention programs that PEPFAR does, which are not of the woke nature, which can prevent someone from getting HIV,” Alford countered. “Are those programs going to survive?”
- “It is something that our budget will be very trim on because we believe that many of these nonprofits are not geared toward the viewpoints of the administration, and we’re $37 trillion in debt,” Vought responded. “So, at some point, the continent of Africa needs to absorb more of the burden of providing this health care.”
- https://thehill.com/business/budget/5333521-wh-budget-chief-pepfar-funds-africa
The Trump Administration’s Foreign Aid Review: Status of U.S. Support for Gavi, the Vaccine Alliance
- Starting on the first day of his second term, President Trump issued several executive actions that have fundamentally changed foreign assistance.
- These included:
- an executive order which called for a 90-day review of foreign aid
- a subsequent “stop-work order” that froze all payments and services for work already underway
- the dissolution of USAID, including the reduction of most staff and contractors
- the cancellation of most foreign assistance awards.
- Although a waiver to allow life-saving humanitarian assistance was issued, it has been limited to certain services only and difficult for program implementers to obtain.
- Recent changes to the Department of Health and Human Services, including proposed cuts and reorganization, are also likely to affect these programs.
- This fact sheet is part of a series on the status of U.S. global health programs.
- https://www.kff.org/global-health-policy/fact-sheet/the-trump-administrations-foreign-aid-review-status-of-u-s-support-for-gavi-the-vaccine-alliance/
KEY FEDERAL GOVERNMENT NEWS
Administration Releases Additional Details of Fiscal Year 2026 Budget Request
- On May 30, 2025, the administration released additional details of its Fiscal Year 2026 budget request, including more specific information on funding for global health activities at the State Department, U.S. Agency for International Development (USAID), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH).
- The proposed budget includes significant reductions in global health funding including the elimination of some programs and activities:
- Global Health Programs (GHP) Account (below the FY 2025 amount)
- Funding for Bilaterial Programs (significantly reduced levels)
- Funding for Multilateral Organizations such as The Global Fund to Fight AIDS, Tuberculosis and Malaria (does not include a specific funding amount)
- CDC’s Global Health Center (eliminates CDC’s Global Health Center and funding)
- Fogarty International Center (FIC) (Eliminates FIC)
- Analysis: https://www.kff.org/global-health-policy/fact-sheet/administration-releases-additional-details-of-fiscal-year-2026-budget-request/
- Overview article: https://www.devex.com/news/devex-checkup-trump-admin-proposes-sweeping-cuts-to-global-health-110226
- HHS Budget in Brief: https://www.hhs.gov/about/budget/fy2026/index.html
Five FDA Takeaways from the FY26 Budget
- Here are five takeaways from the recently released Food and Drug Administration (FDA) FY26 Justification for Appropriations Committees (the Congressional Justification):
- Relatively stable funding: The FY26 budget provides $6.8 billion for FDA, which is an overall decrease of $271 million (3.9%) compared the enacted FY25 level.
- Ensures user fee continuity: Under the FY26 budget, funding for FDA would continue to be a combination of $3.2 billion in discretionary budget authority (a decrease of 11.4%) and $3.6 billion in user fees (a 4% increase).
- Advancing MAHA: The administration’s “Make America Healthy Again” (MAHA) policy agenda is prioritized and related areas of focus are prominently featured throughout FDA’s budget materials, including an increase of $234.6 million to “address the nation’s chronic disease epidemic, restore public trust in our food system, and strengthen our nation’s nutritional and food safety.”
- More details on “DOGE” impact and efforts to streamline: The FY26 budget seeks to build on the efforts underway to consolidate core functions and gain efficiencies and envisions a reduction of $626 million due to streamlining functions across the agency.
- More to come: The annual release of the President’s budget is a key step in the process by which FDA is funded but it is not the last. Congress has already begun the FY26 appropriations process, which will continue to play out in the coming weeks and months.
- https://www.akingump.com/en/insights/blogs/eye-on-fda/five-fda-takeaways-from-the-fy26-budget
FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation
- On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.”
- According to FDA, Elsa is a high-security, large language AI tool in the GovCloud environment “that offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency.”
- The model is already being used by the agency to “accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.”
- While the use of AI may help to build efficiencies into FDA processes, it also gives rise to a number of considerations for regulated industry:
- Strategies for Responding to AI-Generated Review Findings
- Submission Format and Data Quality
- Review Timeline and Fee Programs
- Analysis: https://www.morganlewis.com/blogs/asprescribed/2025/06/fdas-ai-assisted-review-the-next-stage-of-regulated-product-evaluation#page=1
- FDA Announcement: https://www.fda.gov/news-events/press-announcements/fda-launches-agency-wide-ai-tool-optimize-performance-american-people
CMS commits to tech initiatives to give Medicare patients, providers easier access to health data
- The Centers for Medicare and Medicaid Services plans to undertake several new health tech initiatives, senior leaders announced today at a closed meeting with stakeholders.
- The Department of Health and Human Services held a meeting today to discuss health tech policy and its recent request for information on health tech initiatives.
- HHS leaders outlined several upcoming tech initiatives to benefit providers and patients, according to individuals who attended the meeting and spoke to Fierce Healthcare:
- CMS plans to build a national healthcare directory, starting with provider information. The goal of the national provider directory, a source that attended the meeting wrote, is to establish a single source of truth for provider information that others can build upon.
- CMS plans to implement a federated, modern identity verification solution to Medicare, with leaders pointing to Login.gov or CLEAR as examples. Individuals will verify their identity once and use it across multiple systems including providers and payers.
- CMS plans to create a type of digital insurance card for Medicare beneficiaries allowing for real-time access to coverage information for patients and providers. It will also expand patient access APIs through Blue Button and make APIs more usable and scalable.
- CMS will also take its Data at the Point of Care from a pilot into general availability. The program enables providers to access Medicare claims data for their patients directly within their workflow.
- CMS will fully participate in the trusted data exchange to better respond to patient and provider requests and create a more interoperable and patient-centric system.
- CMS confirmed the new initiatives in a series of posts on X on Tuesday evening, though it did not provide any additional details on the new projects.
- https://www.fiercehealthcare.com/health-tech/cms-rolling-out-new-tech-initiatives-providers-and-patients
Trump Cuts NIH Grants Research
- In his first months in office, President Trump has slashed funding for medical research, threatening a longstanding alliance between the federal government and universities that helped make the United States the world leader in medical science.
- To understand the cuts, The Times trawled through detailed grant data from the National Institutes of Health, interviewed dozens of affected researchers and spoke to agency insiders who said that their government jobs have become unrecognizable.
- The federal government has announced the termination of 1,389 awards, with more than $820 million in recent funding.
- N.I.H. grants, awarded in a competitive process, are typically paid out in installments. A researcher with a $1 million four-year grant, for instance, will get about $250,000 a year. Scientists can use this money to buy equipment and supplies and to pay the salaries of the researchers who work in their labs, among other things.
- From 2015 to 2024, there have been fewer than 20 terminations a year, on average, according to Jeremy M. Berg, former director of the National Institute of General Medical Sciences at the N.I.H. from 2003 to 2011. They were generally for extenuating circumstances, such as illness or research misconduct.
- But since late February, the government has publicly announced the cancellation of 1,389 N.I.H. awards.
- https://www.nytimes.com/interactive/2025/06/04/health/trump-cuts-nih-grants-research.html (subscription required for full text)
10.9 million people would lose health insurance under Trump’s tax cut bill, CBO projects
- House Republicans’ tax bill would lead to nearly 11 million people losing health insurance, providing a key source of savings to help finance President Trump’s tax cuts, according to projections that nonpartisan congressional scorekeepers published Wednesday.
- Another 5.1 million people would become uninsured from a combination of expiring Affordable Care Act subsidies and new ACA rules that Trump’s health department proposed, the Congressional Budget Office said.
- Those coverage losses are separate from the CBO’s official score of the tax bill.
- Altogether, 16 million people could become uninsured over a decade, the same number who were at risk of losing their insurance when Republicans attempted to repeal the Affordable Care Act in 2017, CBO said.
- Article: https://www.statnews.com/2025/06/04/trump-tax-bill-health-care-impact-cbo-says-nearly-11-million-people-will-lose-insurance/ (subscription required for full text)
- CBO Estimates of H.R.1: https://www.cbo.gov/publication/61461
HHS Announces Paula M. Stannard as Director of the Office for Civil Rights
- The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announces the appointment of Paula M. Stannard as Director of the Office for Civil Rights.
- In this role, Director Stannard is the Department’s chief officer and adviser to Secretary Robert F. Kennedy, Jr. concerning the implementation, compliance, and enforcement of Federal health information privacy, security, and breach notification rules under the Health Insurance Portability and Accountability Act (HIPAA) as well as Federal civil rights, conscience, and religious freedom laws in HHS’ jurisdiction.
- https://www.hhs.gov/press-room/ocr-announces-director.html
Budget for Veterans to See Private Doctors Would See Big Boost in GOP's VA Funding Proposal
- The program that allows veterans to see private doctors using Department of Veterans Affairs funding would get a 50% boost under a spending plan released by House Republicans on Wednesday.
- Overall, the House Appropriations Committee's fiscal 2026 VA spending bill would give the department about $453 billion -- a whopping $83 billion more than Congress approved for the department for this year.
- Most of that increase would be slated for so-called mandatory spending, the type of funding that goes to benefits such as veterans disability pay.
- Discretionary spending -- the type of funding that is mostly used for medical care -- would get a 4% bump to about $134 billion.
- https://www.military.com/daily-news/2025/06/04/budget-veterans-see-private-doctors-would-see-big-boost-gops-va-funding-proposal.html
State exchange directors press senators to extend ACA tax credits
- Leaders at state-based insurance exchanges are expressing concern about the impact that the Republicans' "Big Beautiful Bill" could have on people enrolled in Affordable Care Act (ACA) plans.
- In a letter (PDF) sent to key Senate healthcare leaders on both sides of the aisle, the directors warn that proposals in the bill would drive up costs for the privately insured, and the end of the premium tax credits would likely push more than 4 million people off of their coverage.
- They note that enrollees in marketplace plans are already vetted rigorously for eligibility for tax credits based on both federal and state data. The bill, however, would change the existing process and likely cause a significant administrative burden, particularly on the most vulnerable members.
- Press: https://www.fiercehealthcare.com/regulatory/state-exchange-directors-press-senators-extend-aca-tax-credits
- Letter: https://eadn-wc02-12144036.nxedge.io/wp-content/uploads/2025/06/SBM-Reconciliation-Letter-to-Senate.pdf
CDC Clarifies That Kids May Receive COVID-19 Vaccine Through Shared Clinical Decision-Making
- Following the announcement from Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr that the CDC will no longer be recommending that healthy children and pregnant individuals receive routine COVID-19 vaccinations, the CDC has updated its Child and Adolescent Immunization Schedule. Notably, the new schedule still lists COVID-19 vaccines as something healthy individuals aged 6 months to 17 years “may receive” through “shared clinical decision-making.”
- According to the updated guidance, shared clinical decision-making is undertaken on an individual basis, informed by conversations between the child’s parent and/or guardian and a health care provider.
- Whether informed by the clinical judgment of a health care provider, personal preference, or unique circumstances, if a parent presents with a clear desire for their child to be vaccinated, children 6 months and older may receive a COVID-19 vaccination.
- https://www.pharmacytimes.com/view/cdc-clarifies-that-kids-may-receive-covid-19-vaccine-through-shared-clinical-decision-making
Trump Administration Is Ending Multiple HIV Vaccine Studies, Scientists and Officials Say
- The Trump administration has moved to end funding for a broad swath of HIV vaccine research, saying current approaches are enough to counter the virus, several scientists and federal health officials say.
- Notifications that the funding would not be extended were relayed May 30 to researchers, who were told by National Institutes of Health officials that the Department of Health and Human Services had elected “to go with currently available approaches to eliminate HIV” instead.
- The cuts will shutter two major HIV vaccine research efforts first funded by the NIH in 2012 at the Duke Human Vaccine Institute and the Scripps Research Institute, scientists said. A Moderna spokesperson said the vaccine manufacturer’s clinical trials through the NIH’s HIV Vaccine Trials Network have also been put on pause.
- One senior NIH official said the HHS had instructed the agency not to issue any more funding in the next fiscal year for HIV vaccine research, with only a handful of exceptions.
- A budgetary rule change specifically targeted at HIV vaccine research is also expected to lead to another cut to the NIH’s awards for studies initiated by scientists, an official said.
- https://kffhealthnews.org/news/article/hiv-vaccine-research-cuts-trump-administration/
KEY REVERSALS – RESCINDED ITEMS
Trump asks Congress to pull $9B in funding for NPR, PBS, foreign aid
- President Trump formally asked Congress on Tuesday to rescind $9.4 billion in already approved funding for foreign aid and the Corporation of Public Broadcasting (CPB), which funds NPR and PBS.
- Why it matters: The rescissions package is an attempt to codify DOGE-driven cuts amid a wider push from the Trump administration to target news organizations perceived to be biased against Republicans.
- Details: Congressional Republican leaders in a Tuesday night joint statement confirmed they had received Trump's recessions request to revoke $8.3 billion in funding for foreign assistance, from USAID and the African Development Foundation, and $1.1 billion from the CPB.
- https://www.axios.com/2025/06/04/trump-congress-npr-pbs-funding-public-broadcasting
Trump administration ends emergency abortion requirement for hospitals
- The Trump administration has rescinded Biden-era guidance requiring hospitals to provide emergency abortions when necessary to stabilize a patient’s health — even in states that ban the procedure.
- The Centers for Medicare and Medicaid Services announced the change Tuesday, saying the guidance did not “reflect the policy of this Administration.”
- The Biden administration had issued the guidance in July 2022, weeks after the Supreme Court overturned Roe v. Wade, ending the national right to abortion, to clarify that a federal law guaranteeing emergency care for patients in peril took precedence over state abortion bans.
- In a statement Tuesday, CMS said it would continue enforcing EMTALA, including “for identified emergency medical conditions that place the health of a pregnant woman or her unborn child in serious jeopardy.”
- The agency added that it would “work to rectify any perceived legal confusion and instability created by the former administration’s actions.”
- Press: https://www.washingtonpost.com/nation/2025/06/04/emtala-emergency-abortion-guidance (subscription required for full text)
- CMS Announcement: https://www.cms.gov/newsroom/press-releases/cms-statement-emergency-medical-treatment-and-labor-act-emtala
KEY LAWSUITS
Fired HHS Staff Sue RFK Jr., Musk, Claiming Terminations Were Based on ‘Error-Ridden’ Information
- Seven former employees of the Department of Health and Human Services earlier this week sued Secretary Robert F. Kennedy Jr., alleging that the decision to fire them was based on staff records that were “hopelessly error-ridden.”
- The class action complaint, filed on Tuesday, claimed that HHS shared their personnel data with other federal bodies, including the Department of Government Efficiency (DOGE), Office of Personnel Management and the Office of Management and Budget—even as these records contained inaccuracies, and that leaders knew that those records contained inaccuracies.
- Those agencies and officials from them, including FDA commissioner Marty Makary as well as Elon Musk, in his capacity as “de facto leader of DOGE” are also named as defendants.
- “Instead of taking steps to verify the contents of the records and correct the systemic inaccuracies, the agencies promptly used them to fire 10,000 employees,” according to the suit. “That was unlawful and actionable under the Privacy Act.”
- https://www.biospace.com/policy/fired-hhs-staff-sue-rfk-jr-musk-claiming-terminations-were-based-on-error-ridden-information
KEY BIOPHARMA NEWS
HELP Committee Supports Reauthorizing FDA Program to Streamline Review of OTC Drugs
- Lawmakers expressed bipartisan support for reauthorizing an FDA program that helps streamline the process for bringing nonprescription drugs to market during a hearing of the Senate Health, Education, Labor, and Pensions (HELP) Committee on Wednesday.
- Reforms to the regulation of OTC monograph drugs that authorized the FDA to collect user fees from industry were passed as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which was signed into law in March 2020.
- According to Corrigan-Curay, the OTC Monograph Drug User Fee Program was a "bipartisan success." However, reauthorization is critical for the agency to continue to improve the program, and to provide a more nimble, transparent, and accountable regulatory process, she said.
- The deadline for reauthorization is Sept. 30.
- https://www.medpagetoday.com/washington-watch/washington-watch/115912
Senator grills Makary over FDA’s ability to regulate drug ads after OPDP cuts
- In the wake of sweeping cuts at the FDA’s Office of Prescription Drug Promotion (OPDP), Sen. Dick Durbin, D-Ill., is questioning how effectively the agency can continue to regulate pharmaceutical advertisements.
- The lawmaker sent a letter to FDA Commissioner Marty Makary, M.D., this week requesting information about the regulator’s “operational capacity” to carry out that work, citing both the staff cuts and Makary’s own “recent public statements expressing an interest in “mak[ing] sure that the information being presented … in those ads … is a complete picture.”
- The layoffs in particular “raise major questions about whether FDA has the personnel, expertise, and capacity to fulfill its mission to regulate prescription drug advertisements,” Durbin wrote.
- Late last month, the two highest-ranking OPDP leaders reportedly stepped down, following far-reaching layoffs earlier in April that completely cleared out the office’s Division of Promotion Policy, Research and Operations, among other impacted teams.
- https://www.fiercepharma.com/marketing/senator-grills-makary-over-fdas-ability-regulate-drug-ads-after-opdp-cuts
KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS
Quest Diagnostics Minimizes China Tariff Risk With Less Than 1% Supply Chain Exposure
- Quest Diagnostics says it is well-insulated from the US tariffs on Chinese imports, with less than 1% of its $2bn annual supply chain sourced from China.
- During its first-quarter 2025 earnings call on 22 April, company executives said the tariff risk is already accounted for in its 2025 guidance, adding that most supplies are domestically sourced and covered by long-term contracts.
- https://insights.citeline.com/medtech-insight/business/strategy/quest-diagnostics-minimizes-china-tariff-risk-with-less-than-1-supply-chain-exposure-GZNZO5YNEJBNRDBHBQAWBNC3ZE (subscription required for full text)
LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule
- The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
- The US Food and Drug Administration’s long-running effort to regulate lab-developed tests appears to have ended, at least for now, when a 60-day window for the agency to appeal a district court decision vacating a final rule expired without action.
- https://insights.citeline.com/pink-sheet/r-and-d/ldt-final-act-us-fda-will-not-appeal-district-court-decision-vacating-final-rule-3UISX54GHBBG7LG2QSO7QFKJRI/ (subscription required for full text)
KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS
HHS names new technology policy, health IT leader
- The Department of Health and Human Services on Tuesday disclosed that Thomas Keane has been tapped to serve as the agency’s top technology policy official and national coordinator for health IT.
- Keane, a radiologist with previous experience at HHS, is the second person to serve as assistant secretary for technology policy after the role was established under the Biden administration. In a post to LinkedIn on Tuesday, ASTP said Keane’s “leadership will play a pivotal role in shaping the future of #HealthIT and HHS’s technology strategy.”
- Keane joins the office less than a year after it got its new name and responsibilities to develop and oversee the agency’s data, technology and AI policy.
- In July 2024, HHS announced that the national coordinator at the time — Micky Tripathi — would take on the new assistant secretary title, and the department’s chief technology, data and AI officials would be moved under that newly minted arm.
- As a result, the existing Office of the National Coordinator, which already oversaw standards for the exchange of health data, was renamed to reflect its policy role — first to ASTP/ONC and now just ASTP.
- It’s not yet clear whether all of the roles under ASTP will stay put, however. HHS Secretary Robert F. Kennedy, Jr. has launched a departmentwide restructuring and a large-scale reduction-in-force to align with President Donald Trump’s marching orders on reshaping and shrinking the federal government.
- Press: https://fedscoop.com/hhs-names-new-technology-policy-health-it-leader-astp-onc/
- Government site: https://www.healthit.gov/
KEY MEDTECH NEWS
Tariff-driven uncertainty rattles medtech industry
- Major medtech companies are preparing for significant financial headwinds as tariffs threaten to disrupt the $200 billion U.S. medical device market.
- A recent analysis by iData Research warns that import duties—ranging from 10% to as high as 145% on some Chinese goods—could trigger widespread supply chain disruptions and price increases throughout the industry.
- Several industry leaders, including Johnson & Johnson, GE HealthCare and Intuitive Surgical, have already flagged potential financial hits from the evolving tariff landscape.
- The medtech sector is now lobbying for tariff relief, warning that the duties could ripple beyond corporate balance sheets and negatively affect patient access to essential medical technologies.
- AdvaMed, a medtech trade association, has called for exemptions for medical devices, arguing that tariffs could hinder investments in research and development and lead to higher prices for patients.
- https://www.fiercebiotech.com/medtech/tariff-driven-uncertainty-rattles-medtech-industry
KEY ACRONYMS
- ACA = Affordable Care Act
- APIs = application programming interfaces
- ASTP = Assistant Secretary for Technology Policy
- CARES = Coronavirus Aid, Relief, and Economic Security Act
- CDC = Centers for Disease Control and Prevention
- CMS = Centers for Medicare & Medicaid Services
- DOGE = Department of Government Efficiency
- EMTALA = Emergency Medical Treatment & Labor Act
- FDA = Food and Drug Administration
- FIC = Fogarty International Center
- GHP = global health programs
- HELP = Health, Education, Labor, and Pensions (Senate)
- HHS = Department of Health and Human Services
- MAHA = Make America Healthy Again
- NIH = National Institutes of Health
- OCR = Office for Civil Rights
- OPDP = Office of Prescription Drug Promotion
- OTC = over the counter
- PEPFAR = President’s Emergency Plan for AIDS Relief
- USAID = U.S. Agency for International Development
- VA = Department of Veterans Affairs