Blog | 3/14/2025

Trump Administration Healthcare News: March 14, 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 March 13, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global & US & EOs)

The Impact of Tariffs on the Life Sciences Industry

Key Takeaways

  • President Trump announced plans to impose tariffs of at least 25% on the pharmaceutical industry, which could violate WTO rules, increase costs and prices, disrupt supply chains, and affect manufacturing location strategies.
  • Tariffs are likely to significantly impact the medical device industry, which relies on complex supply chains and offshore manufacturing. The newly imposed tariffs on China, Mexico, and Canada affect medical devices, leading to higher costs and potential shortages.

Also Important

  • Increased tariffs mean that pharmaceutical and medical devices, which are generally not subject to customs duty, will now be subject to customs duty on import into the US (and into any other jurisdictions that impose retaliatory tariffs against US originating products).
  • Customs duty is paid as a percentage of the customs value of the imported goods and is a cost that will be borne by the importer (depending on its contractual terms with its customer, it may be possible for this cost to be passed on to the latter).
  • https://www.lexology.com/library/detail.aspx?g=dfddfd20-991e-4c62-9732-2bc4d838ed9b

Judge holds Congress has power on foreign aid spending, not president

  • A federal judge ruled President Trump does not have "unbounded power" on foreign aid and ordered his administration to pay some congressionally appropriated funds that USAID owes grant recipients and contractors.
  • Why it matters: "The constitutional power over whether to spend foreign aid is not the President's own — and it is Congress's own," wrote U.S. District Judge Amir Ali in an order partially granting a preliminary injunction in a lawsuit challenging the Trump administration's moves to gut USAID.
  • "The Court accordingly finds that Plaintiffs are likely to succeed on their separation of powers claims and rejects Defendants' unbridled understanding of the President's foreign policy power."
  • The order prevents the Trump administration from "unlawfully impounding congressionally appropriated foreign aid funds."
  • What they're saying: Secretary of State Marco Rubio said on X earlier Monday the Trump administration was canceling 83% of USAID programs following a six-week review.
  • "In consultation with Congress, we intend for the remaining 18% of programs we are keeping (approximately 1000) to now be administered more effectively under the State Department," said Rubio, USAID's acting administrator, thanking DOGE staff for working on this "overdue and historic reform."
  • https://www.axios.com/2025/03/11/trump-usaid-foreign-aid-payments-power
  • Link to news on Rubio’s announcement: https://www.npr.org/sections/goats-and-soda/2025/03/10/g-s1-52964/rubio-announces-that-83-of-usaid-contracts-will-be-canceled

KEY FEDERAL GOVERNMENT NEWS

Trump’s picks to run FDA and NIH win approval from Senate’s health committee

  • The Senate health committee voted on Thursday to endorse Marty Makary as Food and Drug Administration commissioner and Jay Bhattacharya as director of the National Institutes of Health.
  • The committee voted 14-9 to advance Makary, with Democratic senators Maggie Hassan (N.H.) and John Hickenlooper (Colo.) joining Republicans.
  • The vote for Bhattacharaya was 12-11 along party lines.
  • The next step for the nominees is a vote by the full Senate, where a GOP majority all but ensures they will be confirmed.
  • https://www.statnews.com/2025/03/13/trump-picks-nih-director-jay-bhattacharya-fda-nominee-marty-makary-clear-senate-committee/  (subscription require for full-text)

White House to pull CDC director nomination [Weldon]

  • The White House is withdrawing the nomination of Dave Weldon to be the director of the Centers for Disease Control and Prevention (CDC), per a source close to Senate health committee and another source familiar.
  • Why it matters: The former Florida congressman was scheduled to appear before the committee Thursday morning for his confirmation hearing. But his anti-vaccine views have garnered attention since he was nominated months ago and were sure to play a prominent role in questioning.
  • HHS Secretary Robert F. Kennedy himself said Weldon wasn't ready, per one of the sources.
  • https://www.axios.com/2025/03/13/white-house-pulls-cdc-nomination

CMS Innovation Center Announces Model Portfolio Changes to Better Protect Taxpayers and Help Americans Live Healthier Lives

  • Today, the CMS Innovation Center announced changes to its model portfolio to align with its statutory obligation and strategic goals.
  • Innovation Center Models are time-limited experiments that provide a controlled environment to determine, through rigorous evaluation, what approaches should be expanded nationwide, what specific components of an approach need further testing in successor models and what approaches are not viable for expansion. As is the nature of innovation, not every model will work, and the Center must be efficient and effective in its response.
  • The Center regularly assesses and may amend model activities in response to a model’s projected savings, quality outcomes data, legal compliance, operational feasibility and gaps in expected versus actual impact.
  • The Center aims to end these models early, by December 31, 2025. Most models selected for early termination are within 2 years of their end date.

Models Identified to End Early (Original Performance Period)

  • Maryland Total Cost of Care (2019 – 2026)
  • Primary Care First (2021 – 2026)
  • ESRD Treatment Choices (2021 – 2027; will propose termination through rulemaking)

Also

CMMI to cut participation in payment models, estimates $750M in savings

  • The Center for Medicare and Medicaid Innovation (CMMI) will stop certain payment models by the end of the year.
  • Without going into specifics initially, the Centers for Medicare & Medicaid Services' (CMS') Innovation Center said it conducted a “data-driven review” of all the agency’s models. Some of the models will “conclude as scheduled,” while others will stop by the end of 2025, a news release said.
  • The CMS said this should result in $750 million in savings, without giving more details.
  • The CMS Innovation Center will release a new strategy that is more aligned with the priorities of the new administration, but a timeline for that strategy’s publication was not given.
  • One model that will see the ax is the Medicare $2 Drug List Model, which aimed to cap out-of-pocket generic drugs at $2 a month. This payment model was used to soften the blow of the termination of the Value-Based Insurance Design (VBID) Model, announced at the tail-end of the Biden administration.
  • https://www.fiercehealthcare.com/regulatory/cmmi-cut-short-payment-models-estimates-750m-savings

Center for Biologics Evaluation and Research (CBER) Losing Cell, Gene Therapy Leadership As Workforce Culling Continues

NIH allegedly cancels dozens of grants for vaccine hesitancy research: reports

  • The National Institutes of Health (NIH) is continuing its grant-canceling spree, allegedly targeting dozens of research projects related to studying vaccine hesitancy and improving vaccine rates, according to several news reports.
  • An email sent to NIH leadership and cited by NPR said: "It is the policy of NIH not to prioritize research activities that focuses on gaining scientific knowledge on why individuals are hesitant to be vaccinated and/or explore ways to improve vaccine interest and commitment." 
  • The NIH is also scrutinizing grants related to mRNA vaccines, NPR reports. Acting NIH director Matthew Memoli, M.D., recently asked for data about agency funding that goes toward mRNA vaccine research, according to an email viewed by NPR. 
  • President Donald Trump’s HHS is also currently reevaluating a $590 million contract with Moderna, signed by the Biden administration, to develop mRNA vaccines for different types of influenza, including the current outbreak of bird flu that is infecting chickens and dairy cows around the country.
  • https://www.fiercebiotech.com/research/nih-cancels-dozens-grants-vaccine-hesitancy-research-report The Office of the General Counsel (OGC), otherwise known as the legal team within the Department of Health and Human Services (HHS), is closing six of its 10 regional offices.

The Office of the General Counsel (OGC), otherwise known as the legal team within the Department of Health and Human Services (HHS), is closing six of its 10 regional offices.

  • HHS did not immediately return a request for comment asking how employees at these closed offices will be impacted. The Huffington Post reported the office is planning to reduce the workforce closer to its 2019 staffing levels. Lawyers at these officers enforce nursing home and hospital standards, as well as the Head Start program.
  • The office also created a Chief Counsel for Food, Research and Drugs to supervise the chief counsel at the Food and Drug Administration (FDA) and the National Institutes of Health branch of OGC. It will be led by Robert Foster, the current FDA Chief Counsel and Deputy general Counsel in OGC. At the FDA, he was supposed to be replaced by Hillary Perkins, who spent six years at the Department of Justice. However, she resigned from the position less than one day later.
  • https://www.fiercehealthcare.com/regulatory/federal-government-looks-divest-hhs-cms-headquarters-doge-cancels-leases
  • HHS statement: https://www.hhs.gov/about/news/ogc-reorganization-effort.html

HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe

  • HHS Secretary Robert F. Kennedy Jr. is directing the acting FDA commissioner to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.
  • “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
  • Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.
  • HHS also is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.
  • https://www.hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html

HHS’ Civil Rights Office Investigates Alleged Discrimination in Health Care Workforce and Training to Restore Merit-Based Opportunity

  • In alignment with President Trump’s Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity links to an external website, today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is announcing investigations into four medical schools and hospitals under Title VI of the Civil Rights Act of 1964 (Title VI) and Section 1557 of the Affordable Care Act (Section 1557).
  • These investigations are in response to allegations and information OCR received that certain medical schools and hospitals that receive HHS funding may operate medical education, training, or scholarship programs for current or prospective workforce members that discriminate on the basis of race, color, national origin, or sex.  National policy under Executive Order 14173 directs federal agencies to enforce long-standing civil rights laws and “to combat illegal private sector [diversity, equity and inclusion] DEI preferences, mandates, policies, programs, and activities.”
  • Under Executive Order 14173, each agency, in coordination with the Attorney General, is required to identify “nine potential civil compliance investigations” of corporations, associations, foundations, and institutions of higher education with endowments over 1 billion dollars as part of a strategic enforcement plan.
  • https://www.hhs.gov/about/news/2025/03/07/hhs-civil-rights-office-investigates-alleged-discrimination-health-care-workforce-training-restore-merit-based-opportunity.html

Congress Faces Funding Deadline as Healthcare Extenders Take Priority

For now, reconciliation conversations have slowed as Congress turns its attention toward the March 14, 2025 funding deadline. Healthcare extenders included in the CR include:

  • Extension of certain provisions for low-volume hospitals and the Medicare-dependent hospital program
  • Extension of add-on payments for ambulance services
  • Ongoing funding for quality measure endorsement, input and selection
  • Continued outreach and assistance for low-income programs
  • Extension of the work geographic index floor
  • Prolonged telehealth flexibilities
  • Extension of authorities for acute hospital care at home waivers
  • Temporary inclusion of authorized oral antiviral drugs as covered Part D drugs
  • Delaying Medicaid disproportionate share hospital (DSH) reductions
  • Continuation of Medicare sequestration

However

RFK Jr.’s ‘MAHA’ commission meets for the first time — behind closed doors

  • An array of federal government officials and “Make America Healthy Again” moms met Tuesday in what was the first convening of a new commission led by Health Secretary Robert F. Kennedy Jr.
  • The meeting, held in Washington on Tuesday afternoon, was not made public or announced before it occurred. It marked the start of a monthslong effort, birthed by President Donald Trump’s pen on Feb. 13, which aims to identify and then solve the nation’s chronic ills. The meeting was first reported by the New York Times. STAT independently verified that it took place.
  • Among those empaneled to the MAHA commission are domestic policy advisers, as well as Agriculture Secretary Brooke Rollins and Education Secretary Linda McMahon, who were both in attendance Tuesday. The leaders of the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health are also appointed to the commission.
  • https://www.statnews.com/2025/03/11/rfk-jr-maha-commission-meets-for-the-first-time-behind-closed-doors/  (subscription required for full-text)

CMS scraps contracts to upgrade online Medicare system and hands over control to DOGE, agency says

  • Contractors working to modernize a provider enrollment system have been shown the door, the Centers for Medicare & Medicaid Services (CMS) announced.
  • Instead, CMS will work with the highly influential advisory group Department of Government Efficiency (DOGE) to complete a system overhaul that will be far less costly and time-consuming, the agency said.
  • “Two contractors spent nine years and $200M working on a modern provider enrollment system at CMS,” the agency said in an X post. “After 14 missed deadlines, zero usable output was produced. CMS has now cancelled these two contracts (saving $17.8M annually), has hired multiple software engineers, and, working with DOGE, are accelerating this project.”
  • The online Medicare enrollment system PECOS, or Provider Enrollment, Chain and Ownership System, is likely the system targeted by DOGE in this instance, Fierce Healthcare has learned. PECOS was established as the central electronic system to process payments for every physician accepting Medicare and indicates whether providers are eligible to be paid out in Medicare.
  • https://www.fiercehealthcare.com/providers/cms-scraps-contracts-upgrade-online-medicare-system-hands-over-control-doge

KEY BIOPHARMA NEWS

US tariffs on India will be a bitter pill to swallow

  • With Donald Trump's tit-for-tat tariffs on India looming next month, millions of Americans may have to brace for steeper medical bills.
  • Last week, Indian Commerce Minister Piyush Goyal made an unscheduled trip to the US for discussions with officials, hoping to strike a trade deal.
  • It followed Trump's announcement that he would impose tariffs - which are government taxes on foreign imports - on India by 2 April, in retaliation to India's tariffs on American goods.
  • Goyal wants to stave off tax increases on India's critical export industries like medicinal drugs.
  • Nearly half of all generic medicines taken in the US come from India alone. Generic drugs - which are cheaper versions of brand-name medications - imported from countries like India make up nine out of 10 prescriptions in the US.
  • This saves Washington billions in healthcare costs. In 2022 alone, the savings from Indian generics amounted to a staggering $219bn (£169bn), according to a study by consulting firm IQVIA.
  • Without a trade deal, Trump's tariffs could make some Indian generics unviable, forcing companies to exit part of the market and exacerbating existing drug shortages, experts say.
  • Tariffs could "worsen the demand-supply imbalances" and the uninsured and poor will be left counting the costs, says Dr Melissa Barber, a drug costing expert from Yale University.
  • The effects could be felt across people suffering from a range of health conditions.
  • Over 60% of prescriptions for hypertension and mental health ailments in the US were filled with Indian-made drugs, according to the IQVIA study funded by the Indian Pharmaceutical Alliance (IPA).
  • https://www.bbc.com/news/articles/ckg8ke45gq0o

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

House votes to extend telehealth for 6 months, sends funding bill to Senate

  • The House of Representatives voted 217-213 to pass a continuing resolution that funds the government until Sept. 30, 2025, and extends expiring Medicare telehealth flexibilities until the same date.
  • The funding patch contains limited healthcare extenders and funding. It extends telehealth flexibilities for Medicare beneficiaries and providers, which will allow telehealth visits to be conducted from an expanded list of locations, including the patient's home, and will allow an expanded list of provider types to furnish telehealth.
  • Also for hospitals, it again delays Medicaid disproportionate share hospital reductions while extending increased inpatient hospital payment adjustment for certain low-volume hospitals, the Medicare-dependent hospital program and a 1.0 floor on the work Geographic Practice Cost Index.
  • “Actions speak loudly, and with this short-term government funding legislation, Congress is acting to protect Americans’ healthcare," Chip Kahn, president and CEO of the Federation of American Hospitals (FAH), which represents for-profit hospitals and health systems, said ahead of Tuesday's vote. "We support Congress' efforts—the postponement of harmful Medicaid cuts and the continued support for rural Americans’ healthcare access and seniors’ telehealth services are critical to assuring patients 24/7 care."
  • It does not include a rollback of the 2.83% Medicare physician pay cut that went into effect Jan. 1, a major pain point for physician lobbying groups like the American Medical Association.
  • https://www.fiercehealthcare.com/regulatory/house-extends-telehealth-six-months

KEY LEGAL CHALLENGES

Harvard doctors sue over Trump removal of articles mentioning LGBTQ health issues

  • Doctors from Harvard Medical School have filed a lawsuit challenging the Trump administration's removal of articles about their research from a government-run website focused on patient safety because they referenced people in the LGBTQ communities.
  • Represented by lawyers at the American Civil Liberties Union, Drs. Celeste Royce and Gordon Schiff filed a lawsuit, opens new tabon Tuesday in Boston federal court alleging their articles were removed as a result of an executive order President Donald Trump signed requiring agencies to remove statements promoting "gender ideology."
  • Their articles were published on the Patient Safety Network, a website that features news and resources on patient safety. It is run by the Agency for Healthcare Research and Quality, which is part of the U.S. Department of Health and Human Services.
  • The doctors' lawsuit argues that the Trump administration violated the U.S. Constitution's First Amendment by imposing a viewpoint-based restriction on the doctors' participation in a government-provided forum open to private speakers.
  • The lawsuit also argues the administration violated the Administrative Procedure Act by removing articles without a reasoned basis.
  • https://www.reuters.com/legal/government/harvard-doctors-sue-over-trump-removal-articles-mentioning-lgbtq-health-issues-2025-03-12/

CURRENT APPOINTEE STATUS

 https://ourpublicservice.org/performance-measures/political-appointee-tracker/

KEY ACRONYMS

  • ACA = Affordable Care Act
  • CDRH = Center for Devices and Radiological Health
  • CMMI = Center for Medicare and Medicaid Innovation
  • CMS = Center for Medicare & Medicaid Services
  • DOGE = Department of Government Efficiency
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • HDHP = high-deductible health plans
  • HHS = Department of Health and Human Services
  • OCED = Organisation of Economic Development
  • OCG = Office of the General Counsel
  • OCR = Office for Civil Rights
  • OIRA = Office of Information and Regulatory Affairs
  • OMB = Office of Management and Budget
  • PRAMS = Pregnancy Risk Assessment Monitoring System
  • UNRWA = United Nations Relief and Works Agency
  • USAID = U.S. Agency for International Development
  • WHO = World Health Organization

​​​​

Share this: