Blog | 10/3/2025

Sharp Strategy Spotlight: October 3, 2025

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

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 October 2, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Supreme Court lets Trump withhold $4 billion in foreign aid approved by Congress

  • The Supreme Court on Friday allowed President Donald Trump to freeze $4 billion in foreign aid payments, handing the White House a significant victory in its monthslong quest to claw back spending that was approved by Congress last year.
  • At issue is $4 billion in foreign aid, including for global health and HIV programs, that was allocated by Congress but that Trump deemed wasteful and has been fighting on two fronts. In addition to defending the aid cuts in federal court, his administration is also seeking to “rescind” the money through Congress.
  • In a brief statement explaining its decision, the court said that the Trump administration’s argument that the lower court’s order requiring the money to be spent would affect its “conduct of foreign affairs” appeared to “outweigh the potential harm” faced by the nonprofit groups hoping to compete for that money.
  • “This order should not be read as a final determination on the merits,” the court wrote in its unsigned order. “The relief granted by the court today reflects our preliminary view, consistent with the standards for interim relief.”
  • https://www.cnn.com/2025/09/26/politics/supreme-court-lets-trump-withhold-billions-in-foreign-aid

KEY FEDERAL GOVERNMENT NEWS

HHS plans to furlough more than 40% of staff if government shuts down

  • A shutdown would hit the massive federal healthcare department’s agencies differently. For example, the CMS would lose 47% of its staff, while the CDC and the NIH would lose 64% and 75%, respectively.
  • The HHS plans to furlough 32,460 employees — roughly 41% of its total workforce..
  • The furloughs, which the HHS laid out in a contingency plan, would represent another hit to the massive federal healthcare department, which has already lost thousands of staffers this year amid Trump administration workforce cuts.
  • A shutdown would hit HHS agencies differently depending on their function and how they’re funded.
  • Press with detailed chart by government agency: https://www.healthcaredive.com/news/hhs-furlough-plan-government-shutdown/761450/
  • HHS Press: https://www.hhs.gov/about/budget/fy-2026-hhs-contingency-staffing-plan/index.html

A government shutdown is upon us: What this means for healthcare programs

  • The shutdown occurred because a new fiscal year (FY) started on October 1 (FY 2026), and Congress has yet to enact a discretionary appropriations bill to fund the government.
  • Providers have been asking questions not only about the impact of this “lapse in discretionary appropriations” on Medicare payments and other healthcare programs, but also about the lack of a legislative vehicle in which to include “riders” to extend certain coverage and payment waivers that have existed since the COVID-19 pandemic but are now expired.
  • This article covers:
    • Impact on healthcare riders
    • Impact on HHS and healthcare programs
    • Impact on regulations
  • Analysis: https://www.mcdermottplus.com/blog/regs-eggs/a-government-shutdown-is-upon-us-what-this-means-for-healthcare-programs/

As shutdown hits, FDA submissions must pause

Home hospital programs in ‘terror’ as they grind to halt ahead of government shutdown

  • The Centers for Medicare and Medicaid Services earlier this month told hospitals that barring congressional action, all patients in Medicare-funded hospital at home programs must be discharged or returned to a medical center by midnight Tuesday.
  • With a government shutdown and a lapse in the waiver program increasingly likely, hospital at home initiatives across the country have already shut down. Hackensack Meridian Health in New Jersey stopped admitting patients last Friday and has fully discharged its census. Delaware-based ChristianaCare stopped admitting Medicare patients to its program over the weekend but will continue to admit patients covered by other insurance as those payers permit. Mass General Brigham in Boston, one of the larger programs in the country, has been slowly reducing its census. There were 60 patients admitted at the end of last week. By Monday it had dropped to 40.
  • There are no official numbers on hospital at home capacity nationwide, but 1,000 beds is a reasonable estimate, said David Levine, a physician at Mass General Brigham and leader of a national organization for hospital at home leaders.
  • https://www.statnews.com/2025/09/30/hospital-at-home-program-winds-down-medicare-waiver-expires/   (subscription required for full text)

Trump bets additional $50M on AI to cure childhood cancer

  • President Donald Trump signed an executive order on Tuesday to double the budget for AI-powered childhood cancer research, increasing funding to $100 million annually.
  • The expanded investment will support the accelerated development of improved diagnostics, treatments, prevention strategies and potential cures.
  • The funding will go to the Childhood Cancer Data Initiative (CCDI) at the National Cancer Institute (NCI).
  • CCDI researchers are consolidating diverse data sources into AI-ready formats and applying machine learning to improve clinical trial design and participant selection.
  • In parallel, CCDI aims to enhance clinical trial efficiency by taking advantage of AI to optimize recruitment and interpretation of results, allowing for faster, more equitable access for patients.
  • Press: https://firstwordhealthtech.com/story/6229406   (subscription required for full text)
  • White House: https://www.whitehouse.gov/fact-sheets/2025/09/fact-sheet-president-donald-j-trump-prioritizes-harnessing-american-ai-innovation-to-unlock-cures-for-pediatric-cancer/

Enrollees' premium costs will more than double on average if ACA tax credits expire: study

Administration for Community Living Awards $60 Million to Advance Make America Healthy Again Agenda

  • The U.S. Department of Health and Human Services’ (HHS) Administration for Community Living (ACL) today announced $60 million in new grant awards to states, territories, tribes, and local organizations supporting older adults and Americans with disabilities.
  • These grants will also aid state-based programs in implementing the RAISE Family Caregivers Act recommendations and bolster funding for the National Center for Benefits Outreach & Enrollment and the Senior Medicare Patrol Resource Center – programs that ensure older adults and people with disabilities can access benefits and protect themselves against fraud. Additionally, these resources will aid efforts to expand elder justice innovations and adult protective services in tribal communities to prevent abuse, neglect, and exploitation, as well as supporting services for Holocaust survivors and other older adults with a history of trauma through person-centered, trauma-informed programs.
  • https://www.hhs.gov/press-room/administration-community-living-awards-60-million-dollars-advance-maha-agenda.html

KEY BIOPHARMA NEWS

Trump’s threatened pharma tariffs won’t start Wednesday despite prior warning, White House says

  • The Trump administration is starting to prepare tariffs on some pharma companies, but those levies won’t take effect on Wednesday, a White House official confirmed to Endpoints News.
  • President Donald Trump announced last Thursday in a social media post that beginning Oct. 1, drugmakers that haven’t started construction projects in the US will face 100% tariffs on their branded medicines.
  • But the White House official said Wednesday that the administration will only “begin preparing tariffs” on Oct. 1. The tariffs will apply to companies that aren’t onshoring their manufacturing to the US as well as those that don’t participate in Trump’s most favored nation policy, according to the official.
  • Since Trump’s post last Thursday, a handful of drugmakers have started construction on US-based projects.
  • AbbVie has broken ground on two factories: an API facility in North Chicago, IL, and a $70 million expansion of its Worcester, MA biologics site. Precision Biologics has also started construction for a new site in Las Vegas. Meanwhile, Amgen detailed a $650 million expansion in Puerto Rico, but did not mention if it had started construction.
  • https://endpoints.news/trumps-100-pharma-tariff-wont-start-oct-1-white-house-confirms/   (subscription required for full text)

The Trump Administration Continues to Make Drug Pricing Moves, Announces First MFN Agreement

  • On September 30, the administration unveiled the details of a deal it reached with Pfizer, the first deal negotiated with a pharmaceutical company to bring most-favored-nation (MFN) pricing to Americans and marking a major milestone for the administration’s drug pricing agenda.
  • As outlined in the administration’s announcement of the Pfizer MFN deal, State Medicaid programs will have access to MFN drug prices on Pfizer products.
  • How MFN prices will be situated with respect to the current Medicaid Drug Rebate Program remains to be clarified.
  • The agreement also guarantees MFN prices on all new innovative medicines Pfizer brings to market in the U.S. (presumably for all patients) and requires Pfizer to repatriate increased foreign revenue on existing products that Pfizer realizes as a result of the administration’s trade policies.
  • The agreement also requires Pfizer to offer specific medicines to treat certain chronic illnesses at a deep discount off the list price when selling directly to American patients outside of their health insurance benefits.
  • Analysis: https://www.akingump.com/en/insights/alerts/the-trump-administration-continues-to-make-drug-pricing-moves-announces-first-mfn-agreement
  • News:  https://www.statnews.com/2025/09/30/what-behind-pfizer-trump-drug-price-deal/  (subscription required for full text)

White House announces new prescription drug website, TrumpRx

  • The White House announced Tuesday it was rolling out a direct-to-consumer website where individuals can buy prescription medications at discounted prices rather than through insurance.
  • The new website, called TrumpRx, was unveiled as part of the Trump administration's broader effort to implement a “most favored nation” (MFN) pricing model for prescription drugs, meaning the U.S. pays no more than the lowest prices charged in other wealthy countries.
  • Trump also announced a sweeping deal with pharma giant Pfizer to reduce the price of many of its drugs. Pfizer agreed to provide all of its prescription drugs on Medicaid at reduced MFN drug pricing, Fierce Pharma reported.
  • The deal came as pharma companies faced Trump’s deadline to lower prices under his MFN drug pricing campaign.
  • The White House said in a post on X that "virtually all drugs" will be available discounted on the site. The Trump administration listed four drugs that will be offered through the TrumpRx site: Eucrisa, Duavee, Zavzpret and Xeljanz. All four of those drugs are made by Pfizer.
  • Press: https://www.fiercehealthcare.com/providers/white-house-announces-new-prescription-drug-website-trumprx
  • Analysis:  https://www.axios.com/2025/10/01/trumprx-website-drug-prices-trump-pfizer  (subscription required for full text)

EU, Japan trust they have secured limits to US drug tariffs

  • The European Union and Japan expressed confidence on Friday that they had secured limits on U.S. tariffs on pharmaceuticals, which President Donald Trump said he would impose next week at a rate of 100%.
  • The European Commission referred to a joint statement agreed with the U.S. following its end-July trade deal, which states that the tariff for pharmaceuticals, semiconductors and lumber would not exceed 15%.
  • European Trade Commissioner Maros Sefcovic, speaking in Hanoi, said he expected the commitment to be respected, noting that Washington had followed through in lowering car tariffs.
  • Japan also referred to its joint statement with Washington, which said that U.S. tariff rates on Japanese semiconductors and pharmaceuticals would not exceed those applied to others such as the EU.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/eu-japan-express-confidence-in-capped-us-tariffs-drugs-2025-09-26/

Medicare Delays Combo Drug Negotiation Policy One Year

  • The US Centers for Medicare and Medicaid Services did not advance a proposal to reverse a policy excusing fixed drug combinations from being subject to price negotiation at the same time as an older drug with the same active moiety, but it could emerge again in 2026.
  • CMS’ recently released final guidance on the negotiation program for price implementation year 2028 acknowledged concerns that “manufacturers may use CMS’ existing fixed combination drug policy to avoid aggregation [with an older drug] and therefore selection for negotiation, by making minor changes to an existing drug.”
  • But “due to the complexity and scope of this issue … CMS believes additional time would be necessary to develop objective policy criteria if CMS were to finalize such a policy and thus will not make a change to the fixed combination drug policy in this final guidance,” the agency wrote.
  • Press: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/medicare-delays-combo-drug-negotiation-policy-one-year-K6VL4JGEV5EAXNZ7Y3M7T2NOWU/   (subscription required for full text)
  • CMS Press: https://www.cms.gov/files/document/ipay-2028-final-guidance-fact-sheet.pdf

CMS spells out new orphan drug protections in IRA negotiation guidance

  • CMS finalized guidance this week that the agency says will increase transparency in the third round of Medicare drug price negotiations and “preserve critical incentives for rare disease research.”
  • The guidance sets requirements for the first cycle of negotiations to potentially include drugs payable under Medicare Part B. It also describes how CMS is expanding protections for certain orphan drugs in accordance with President Donald Trump’s recently enacted tax and spending package.
  • Previously, certain orphan drugs were excluded from Medicare negotiations if they were approved to treat a single rare disease or condition. Now, orphan drugs may be excluded if they are approved for more than one indication, as long as it’s another rare disease or condition. If a drug is approved for an indication that isn’t a rare disease or condition, it will no longer be exempt and CMS will determine its eligibility for negotiations based on “the date on which the FDA approves” the non-orphan indication.
  • Press:  https://endpoints.news/third-round-ira-guidance-spells-out-new-orphan-drug-protections/   (subscription required for full text)
  • CMS: https://www.cms.gov/newsroom/press-releases/cms-releases-final-guidance-initial-price-applicability-year-2028

FDA lists its upcoming research priorities for generic drugs

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

The NIH Venture Program Announces First Award for the BEACONS Initiative

  • The National Institutes of Health (NIH) Common Fund Venture Program has announced its first award for the Building Evidence and Collaboration for GenOmics in Nationwide Newborn Screening (BEACONS) initiative.
  • BEACONS is designed to assess the feasibility of integrating whole genome sequencing into the U.S. newborn screening program.
  • The goal is to make this technology easier and more affordable for states to access, while addressing parents’ and caregivers’ concerns about privacy and consent issues and focusing on only those genes and variants that are treatable in the first year of life.
  • Ultimately, BEACONS aims to make it possible for every newborn to receive testing for serious genetic disorders at the time when treatments are most effective.
  • Over the three years of the initiative, NIH will fund approximately $14.4 million pending successful completion of milestones and availability of funds.
  • The Venture Program BEACONS initiative is a cooperative effort between the Common Fund, the National Center for Advancing Translational Sciences (NCATS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). 
  • https://commonfund.nih.gov/venture/nbsxwgs/news/nih-venture-program-announces-first-award-beacons-initiative

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Some telehealth and home care frozen by shutdown

  • The government shutdown left some seniors without access to telehealth, while others receiving hospital-level care at home are being discharged or sent back to inpatient units.
  • The big picture: Congress only authorized Medicare to pay for expanded telehealth care and the Acute Care Hospital at Home initiative through Sept. 30 — meaning additional legislation is required to restore the services.
    • Most other Medicare and Medicaid services will continue as normal during the shutdown, and providers' insurance claims will still be paid out.
    • "Real Americans will be worse off" without coverage of these services, said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association.
  • Where it stands: All hospitals participating in the hospital-at-home initiative had to discharge patients or move them to physical hospitals on Tuesday after government funding lapsed without Congress renewing the program, per a recent notice from Medicare administrators.
    • Several health systems like Mass General Brigham in Boston and Hackensack Meridian Health in New Jersey started phasing out their hospital-at-home patients early, in anticipation of a shutdown. That further strained already crowded inpatient facilities, Stat News reported.
  • Providers can still offer telehealth services to all Medicare enrollees — they just won't get paid for it. Congress could authorize back pay for claims made during the shutdown if it chooses to extend the programs.
    • Telehealth coverage will remain intact for Medicare enrollees in rural areas accessing a call in a health care setting.
    • Some health systems and Medicare group practices that belong to the American Telemedicine Association are cutting off seniors' telehealth access starting Wednesday, Zebley said.
    • Others will continue providing virtual care to Medicare enrollees but hold off on submitting claims until the shutdown is resolved, in hopes they can get paid retroactively, he said.
  • https://www.axios.com/2025/10/01/telehealth-services-seniors-shutdown   (subscription required for full text)

KEY MEDTECH NEWS

FDA expands Early Alert program to all medical devices

  • The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues.
  • The agency’s Center for Devices and Radiological Health piloted the program in November 2024. The system was designed to reduce the time between when the agency first learns of a product removal or correction and when patients and providers are notified.
  • The program’s expansion, effective Sept. 29, means the FDA will now issue early alerts for all medical devices.
  • Unlike formal recall notices, early alerts signal when device makers remove products, update instructions or make corrections due to safety risks — even before the FDA confirms the issue meets the definition of a recall.
  • https://www.beckershospitalreview.com/supply-chain/fda-expands-early-alert-program-to-all-medical-devices/

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACL = Administration for Community Living
  • BEACONS = Building Evidence and Collaboration for GenOmics in Nationwide Newborn Screening
  • CCDI = Childhood Cancer Data Initiative
  • CDC = Centers for Disease Control and Prevention
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • GDUFA III = Generic Drug User Fee Amendments Round #3
  • HHS = Department of Health and Human Services
  • MFN = most favored nation
  • NCI = National Cancer Institute
  • NIH = National Institutes of Health
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  • MOUD = medications for opioid use disorder
  • NIH = National Institutes of Health
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • SOR = State Opioid Response
  • TOR = Tribal Opioid Response
  • USPHS = U.S. Public Health Service
  • VSD = Vaccine Safety Datalink

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