Blog | 11/21/2025

Sharp Strategy Spotlight: November 21, 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 November 20, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

First doses of HIV prevention drug lenacapavir delivered to Zambia, Eswatini  (but not South Africa)

  • About 1,000 doses of Gilead Sciences Inc's drug lenacapavir were delivered to Zambia and Eswatini last Thursday, U.S. and company officials said, the first delivery under a U.S. scheme to supply the HIV prevention drug to countries with a high prevalence of the virus that causes AIDS.
  • Zambia and Eswatini each received roughly 500 doses, and Gilead is working to receive regulatory approval for distribution in other so-called high-burden sub-Saharan countries. The African region remains the epicenter of the AIDS pandemic.
  • But the United States will not provide U.S.-funded doses to South Africa, which has the world's highest HIV burden with about 8 million people, or one in five adults, living with the virus.
  • "Obviously we encourage every country, including countries like South Africa that have significant means of their own, to fund doses for their own population ... U.S.-funded doses will not be going to South Africa," Jeremy Lewin, senior U.S. State Department official for foreign assistance, told reporters on Monday.
  • U.S. President Donald Trump has clashed with South Africa, confronting South African President Cyril Ramaphosa in May with explosive false claims of white genocide and land seizures during a tense White House meeting.
  • Trump also canceled much-needed aid to the country, expelled South Africa's ambassador and criticized its genocide court case against Israel.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/first-doses-hiv-prevention-drug-lenacapavir-delivered-zambia-eswatini-2025-11-18/  

RFK Jr.’s warnings on thimerosal in vaccines threaten to instill doubt overseas, experts fear

  • Earlier this month, health secretary Robert F. Kennedy Jr., a longtime vaccine critic, urged countries around the world to follow the lead of the United States and disallow the use of the preservative thimerosal in vaccines.
  • Infectious diseases experts generally do not think either Kennedy or the U.S. currently has the clout to convince nations elsewhere to act on that advice, particularly because thimerosal plays an important role in safeguarding vaccines in much of the world. But they worry that by pushing the very suggestion that the preservative presents a risk in shots — despite peer-reviewed scientific studies that have found otherwise — Kennedy may plant seeds of doubt that could erode vaccination rates in other parts of the globe.
  • “I don’t think it’s far-fetched to think that this could permeate in other parts of the world,” said Krutika Kuppalli, an infectious diseases specialist in Texas who spent several years as a medical officer at the World Health Organization during the Covid-19 pandemic and the first global mpox outbreak.
  • https://www.statnews.com/2025/11/19/rfk-jr-warning-thimerosal-vaccine-preservative-raises-concern/    (subscription required for full text)

KEY FEDERAL GOVERNMENT NEWS

NIH Cuts Disrupted Hundreds of Clinical Trials, Study Finds

  • Hundreds of clinical trials and tens of thousands of participants were affected by NIH grant terminations earlier this year, a cross-sectional study indicated.
  • Between February 28 and August 15, there were 11,008 clinical trials funded by NIH grants, and 383 of these trials (3.5%) subsequently lost funding, reported Anupam Jena, MD, PhD, of Harvard Medical School and Massachusetts General Hospital in Boston, and the National Bureau of Economic Research in Cambridge, and colleagues.
  • They also showed that more than 74,000 patients were affected by grant funding disruptions, based on the number of active clinical trials, they reported in JAMA Internal Medicine.
  • Infectious disease clinical trials took the biggest hit (n=97 of 675 or 14.4%), followed by prevention trials (n=123 of 1,460 or 8.4%), and behavioral interventions (n=177 of 3,510 or 5%).
  • Among U.S.-based trials, those in the northeast took the biggest hit, with 6.3% having been terminated, followed by the south at 3%, they reported.
  • Trials conducted outside the U.S., however, faced significantly higher rates of termination compared with U.S. trials (5.8% vs 3.4%, P=0.009).
  • Press: https://www.medpagetoday.com/publichealthpolicy/healthpolicy/118570
  • JAMA Internal Medicine: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2840939  (subscription required for full text)

CMS: Medicare Part B premiums set to rise in 2026

Trump says he would only approve direct health care payment legislation

  • President Trump on Tuesday said amid rising health care premiums he would only consider approving legislation that provides a pathway for direct health care payments.
  • “THE ONLY HEALTHCARE I WILL SUPPORT OR APPROVE IS SENDING THE MONEY DIRECTLY BACK TO THE PEOPLE, WITH NOTHING GOING TO THE BIG, FAT, RICH INSURANCE COMPANIES, WHO HAVE MADE $TRILLIONS, AND RIPPED OFF AMERICA LONG ENOUGH,” Trump wrote in a statement on Truth Social.
  • Affordable Care Act (ACA) premium subsidies are set to expire at the end of the year, causing health care costs to skyrocket for Americans if a new solution isn’t reached before 2026.
  • Trump’s Tuesday post follows remarks he made over the weekend touting “personal talks with Democrats” in regards to the measure.
  • https://thehill.com/homenews/administration/5610525-trump-direct-healthcare-payments/ 

Health data staggers back post-shutdown

  • Some closely watched federal health websites and datasets that went dark during the government shutdown haven't been updated since the reopening.
  • Why it matters: The pause in critical information leaves the public and providers in the dark about threats with the holidays approaching.
  • The big picture: With vaccination rates falling, a new flu strain on the rise and bird flu returning, public health authorities need reliable data to make timely decisions, especially as more people gather indoors.
  • State of play: Government trackers on matters like Food and Drug Administration drug recalls and measles outbreaks have remained current, and the Centers for Disease Control and Prevention's FluView was updated late last week.
    • But the CDC's Morbidity and Mortality Weekly Report, a compendium of public health information and recommendations, hasn't published since Oct. 2, while estimates of COVID-19 vaccine coverage were last updated in May.
    • Outbreaks of pertussis, or whooping cough, were last updated in June.
    • Wastewater surveillance data used to track the spread of COVID, flu and RSV hasn't changed since before the shutdown. The government says it's due to be updated later this week.
  • https://www.axios.com/2025/11/18/government-shutdown-cdc-covid-flu-strain-warnings   (subscription required for full text)

5 takeaways from the Senate Finance Committee hearing

Calley Means Returns to Kennedy’s Side as Senior Adviser

  • Calley Means, a health care entrepreneur and key adviser to Health Secretary Robert F. Kennedy Jr., is back in the federal health department.
  • The directory for the Department of Health and Human Services now lists Mr. Means as a senior adviser. Andrew Nixon, a representative for the department, confirmed to The New York Times on Tuesday that Mr. Means had been hired, and said he would support food and nutrition policy in his new role.
  • Mr. Means previously served as a special government employee, a temporary position limited to a 130-day term. He said last month that he had vacated the role.

Senate committee advances a Trump-aligned pick for HHS watchdog

  • A U.S. Senate committee on Wednesday voted to advance a candidate openly supportive of President Donald Trump to be inspector general for the Department of Health and Human Services, a role that is traditionally viewed as nonpartisan.
  • The 14-13 vote in the Republican-led Senate Finance Committee sends Thomas March Bell’s nomination to the full, Republican-controlled Senate, where he is expected to be confirmed to lead the office charged with investigating fraud, waste and abuse in the federal Medicare and Medicaid programs.
  • The Republican candidate’s outspoken alignment with Trump and his history of working for GOP lawmakers for decades have raised questions about his independence for a role that’s intended to scrutinize and root out fraud in some of the nation’s biggest spending programs. A number of Democratic lawmakers have criticized Bell’s nomination.
  • https://apnews.com/article/thomas-march-bell-hhs-inspector-general-trump-fa59fed7cb6fe3da52684fa6bca27bec

US HHS proposes new CDC programs, including hepatitis B screening for pregnant women

  • The U.S. Department of Health and Human Services has proposed new initiatives for the Centers for Disease Control and Prevention, including a program to increase hepatitis B screening for pregnant women, Bloomberg News reported on Wednesday.
  • The proposals include 16 initiatives that have yet to be formalized, with details to be settled before they are rolled out to the CDC in January, the report said, citing internal documents.
  • Former Department of Government Efficiency official Sam Beyda, who was recently named as the CDC's deputy chief of staff, will lead five initiatives, the report added.
  • The list was developed over the past several months in collaboration with senior HHS advisers and CDC leadership, the report said.
  • Reuters could not immediately verify the report.
  • HHS and CDC did not immediately respond to requests for comment.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-health-agency-proposes-new-cdc-programs-including-increased-hepatitis-b-2025-11-20/

CDC Changes Webpage to Say Vaccines May Cause Autism, Revising Prior Language

  • A Centers for Disease Control and Prevention webpage that previously made the case that vaccines don’t cause autism now says they might.
  • The contents of the webpage came up during Health Secretary Robert F. Kennedy Jr.’s Senate confirmation process. Sen. Bill Cassidy (R., La.) in February said Kennedy had assured him that, if he was confirmed, the CDC would “not remove statements on their website pointing out that vaccines do not cause autism.”
  • The revised webpage says: “The claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism. Studies supporting a link have been ignored by health authorities.”
  • The new text posted Wednesday also notes that the Department of Health and Human Services has launched “a comprehensive assessment” to probe the causes of autism.
  • The page previously said: “Studies have shown that there is no link between receiving vaccines and developing autism,” citing a 2012 National Academy of Medicine review of scientific papers and a 2013 CDC study.
  • https://www.wsj.com/health/healthcare/cdc-changes-webpage-to-say-vaccines-may-cause-autism-revising-prior-language-061e2dc2    (subscription required for full text)

The health impact of Trump's new "public charge" rule

  • The Trump administration is proposing to weigh immigrants' use of programs like Medicaid or SNAP, as well as other public benefits, when determining if they should get permanent residency.
  • Why it matters: The proposal is another case of the administration putting public health on a collision course with immigration policy.
  • Driving the news: A homeland security proposal published this week lays out a new version of a "public charge" policy, which was expanded during Trump's first term and then rolled back during the Biden years.
    • Critics say the latest effort, if finalized, could further discourage the use of health, nutrition and housing services after the GOP reconciliation package limited legal immigrants' access to health insurance.
  • State of play: The Department of Homeland Security on Monday said the policy could save nearly $90 billion over a decade as people unenroll from or skip out on public programs.
    • The 140-page rule seeks to override previous policies that outlined which public benefits could disqualify immigrants from getting a green card, instead leaving decisions to the discretion of individual immigration officers on a case-by-case basis.
    • Limiting criteria goes against congressional intent, DHS wrote. The change could mean that officers also consider use of services beyond Medicaid, like getting care at a community health center, when looking at green card applications, legal experts told Axios.
    • The agency said it will issue policy and "interpretive tools" to aid officers' determinations, at an unspecified future date.
  • Analysis: https://www.axios.com/2025/11/20/trump-public-charge-rule-health-impact   (subscription required for full text)
  • Proposal: https://www.federalregister.gov/documents/2025/11/19/2025-20278/public-charge-ground-of-inadmissibility#p-522

Makary skeptical of trial data from China, as FDA pushes 'America First' user fees

  • FDA Commissioner Marty Makary is embracing the Trump administration’s “America First” mantra, seeking potentially higher user fees for companies operating outside the US.
  • “If your Phase 1 trial is not in the United States, maybe you should pay a higher user fee,” Makary said at a supply chain resiliency meeting at the National Academies of Sciences, Engineering, and Medicine late last month.  The FDA and industry are about to kick off negotiations for the next round of user fees under PDUFA VIII, which will run from 2028 through 2032.
  • Asked whether the FDA will call for higher ex-US user fees in the negotiations over the next year, an FDA spokesperson told Endpoints News on Tuesday that the administration “is prioritizing an America first approach to all activities, including drug development and research. FDA is considering a wide range of options to support American innovation and ensure the integrity and accuracy of clinical trials for products that Americans depend on.”
  • Makary also said at the event that he’s dubious of the trustworthiness of Phase 3 trials coming from China. He said the agency rejected, for the first time, a Phase 3 trial from China “several months ago” related to an unnamed application. The FDA did not respond to a request to clarify which trial he meant.
  • https://endpoints.news/makary-calls-for-america-first-drug-user-fee-renegotiations/   (subscription required for full text)

States project flat Medicaid enrollment, increased spending as cuts loom

  • Medicaid enrollment declined this year as states ended pandemic-era continuous enrollment policies, but spending rose — and looming cuts to the safety-net insurance program means more cost pressures are on the horizon, according to a report published Thursday by KFF.
  • Enrollment fell 7.6% in fiscal year 2025, and it’s expected to be largely flat in fiscal year 2026, according to the survey of state Medicaid directors. Meanwhile, total spending grew by 8.6% in 2025, and costs are projected to grow by 7.9% in 2026.
  • Provider rate hikes and greater health needs among beneficiaries alongside rising costs for long-term care, pharmacy benefits and behavioral healthcare are the biggest drivers of increased spending, states said.
  • Analysis: https://www.medtechdive.com/news/medicaid-enrollment-flat-spending-increase-cuts-kff/805879/
  • Report: https://www.kff.org/medicaid/medicaid-enrollment-spending-growth-fy-2025-2026/

HHS Launches New Caregiving AI Initiative to ‘Spark Innovative Support’

  • The U.S. Department of Health and Human Services (HHS) has unveiled a new artificial intelligence (AI) technology initiative designed to improve family caregiver support and strengthen the nation’s health care workforce.
  • The new Caregiver AI Challenge is a national competition that encourages the development of innovative technologies aimed at improving outcomes, efficiency and sustainability amid rising demand for home-based care.
  • Winners of the AI competition will receive a $2 million prize for the best ideas that build up support, reduce stress and expand training opportunities for both paid and family caregivers.
  • The Caregiver AI challenge will unfold in three phases of design, testing and scaling (or implementation).
  • The AI tools will be evaluated based on the ability to assist caregivers in their daily tasks such as medical appointment management, monitoring an individual’s needs and providing person-centered support.
  • Press: https://hospicenews.com/2025/11/18/hhs-launches-new-caregiving-ai-initiative-to-spark-innovative-support/
  • HHS Press: https://www.hhs.gov/press-room/hhs-backs-ai-innovation-for-americas-caregivers.html 

HHS Releases Peer-Reviewed Report Discrediting Pediatric Sex-Rejecting Procedures

  • The U.S. Department of Health and Human Services (HHS) today published Treatment for Pediatric Gender Dysphoria: Review of Evidence and Best Practices, its peer-reviewed study of the medical dangers posed to children from attempts to change their biological sex.
  • The report, released through the Office of the Assistant Secretary for Health, finds that the harms from sex-rejecting procedures — including puberty blockers, cross-sex hormones, and surgical operations — are significant, long term, and too often ignored or inadequately tracked.
  • These conclusions confirm President Trump’s Make America Healthy Again Commission’s findings that unnecessary procedures and long-term health risks such as infertility are the byproduct of the overmedicalization of children.
  • Before submitting its report for peer review, HHS commissioned the most comprehensive study to date of the scientific evidence and clinical practices surrounding the treatment of children and adolescents for “gender dysphoria.” The authors were drawn from disciplines and professional backgrounds spanning medicine, bioethics, psychology, and philosophy.
  • HHS invited the American Academy of Pediatrics and the Endocrine Society to contribute their evidence to this report. Both organizations declined to participate.
  • HHS Press: https://www.hhs.gov/press-room/hhs-releases-peer-reviewed-report-discrediting-pediatric-sex-rejecting-procedures.html
  • Report: https://opa.hhs.gov/gender-dysphoria-report

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

PBMs, FTC clash in court over agency’s in-house insulin challenge

  • An attorney for the nation’s three major pharmacy benefit managers told a federal appeals court on Wednesday that the companies would “unquestionably” be harmed if FTC proceedings against them are allowed to continue.
  • Express Scripts, Caremark, and Optum Rx want the US Court of Appeals for the Eighth Circuit to preliminarily block an FTC administrative challenge accusing them of anticompetitive practices in the insulin market. Daniel Volchok, a WilmerHale attorney representing the companies, said the in-house FTC proceeding is unconstitutional.
  • “Congress has impermissibly given the FTC power that the Constitution assigns to the courts,” Volchok said during an oral argument. “With that power, the FTC is bringing coercive, highly consequential internal proceedings against private parties.”
  • The FTC brought its administrative complaint in 2024, accusing the PBMs of allegedly inflating the price of insulin products. Three of the commissioners who initially voted to bring the complaint — including former FTC Chair Lina Khan — have departed the agency, leading to a brief stay of the case in April. But that same month, Commissioner Andrew Ferguson said he decided to un-recuse himself from the matter “to ensure the case can continue.”
  • The PBMs have argued that the FTC should have raised its complaint in federal court, and that the agency’s internal proceeding deprives them of a “fair and impartial tribunal,” thus violating their due process rights.
  • https://endpoints.news/pbms-ftc-clash-in-court-over-agencys-in-house-insulin-challenge/   (subscription required for full text)

KEY BIOPHARMA NEWS

FDA finalizes guidance on patient-focused drug development

  • The US Food and Drug Administration (FDA) has finalized guidance on patient-focused drug development (PFDD), outlining approaches for sponsors to select, modify, and evaluate clinical outcome assessments (COAs) to support regulatory decisions and medical product development.
  • The guidance is the third in a series of four documents that the agency is developing to advance the PFDD field. This guidance responds to a mandate from the 21st Century Cures Act, which requires the inclusion of such patient experience data in clinical research.
  • “This guidance is intended to help sponsors use high-quality measures of patients’ health in medical product development programs. Ensuring high-quality measurement is important for several reasons: measuring what matters to patients; being clear about what was measured; and appropriately evaluating the effectiveness, tolerability, and safety of medical products. Findings from high-quality measures may help support regulatory decision-making in a variety of contexts,” FDA officials wrote in the guidance.
  • The guidance offers an overview of COAs in clinical trials. It describes the four types of COAs, outlines their role in evaluating clinical benefits, and specifies what each COA assesses. Additionally, it explains the purpose and context of the COAs and determines whether a COA has enough evidence to support its intended use or is suitable for its purpose.
  • The four different types of COA measurements include patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), clinician-reported outcomes (ClinROs), and performance outcomes (PerfOs).
  • Press: https://www.raps.org/news-and-articles/news-articles/2025/11/fda-finalizes-guidance-on-patient-focused-drug-dev
  • Guidance: https://www.federalregister.gov/documents/2025/11/18/2025-20153/patient-focused-drug-development-selecting-developing-or-modifying-fit-for-purpose-clinical-outcome

FDA will allow email 'clarifications' after pharma company meetings

  • To help biopharma companies advance therapies more quickly and better understand what the FDA is asking for, the agency is now allowing companies to email one clarification question after a meeting.
  • The FDA said its Office of New Drugs staff will aim to respond to companies’ questions by email within 3 business days under a pilot program launched last month. The agency noted that it has already provided “several helpful clarifications to sponsors” following receipt of FDA meeting minutes.
  • “In this industry, time is a precious commodity. Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork,” FDA Commissioner Marty Makary said in a statement.
  • The FDA didn’t respond to questions on how long the pilot will run or how many participants there have been.
  • https://endpoints.news/fda-will-allow-email-clarifications-after-pharma-company-meetings/   (subscription required for full text)

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

DEA to publish 4th extension of telehealth prescribing rule in wave of relief for virtual care providers

  • The Drug Enforcement Administration (DEA) appears ready to issue another temporary extension of pandemic-era prescribing flexibilities.
  • Medicare telehealth providers will soon start to receive back pay for the last 42 days of the government shutdown. Many Medicare doctors have continued seeing patients via telehealth since Congress let the clock run out on government funding.
  • The industry is awaiting Centers for Medicare & Medicaid Services guidance on how to proceed with claims processing.
  • Meanwhile, the DEA posted a notice indicating that it will once again extend prescribing flexibilities for providers that prescribe controlled substances via telehealth. The temporary authority—last extended in November 2024—runs out Dec. 31.
  • The Department of Justice, which houses the DEA, has not yet provided details for the rule entitled the “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” One lobbyist suggested the rule is likely a clean, one-year extension.
  • However, the temporary rules, which have been in effect for nearly six years, allow licensed DEA providers to prescribe Schedule 2-5 controlled substances via telehealth without requiring a patient to see the doctor in person.
  • Press: https://www.fiercehealthcare.com/regulatory/dea-publish-fourth-extension-telehealth-prescribing-rule-wave-relief-telehealth
  • Analysis: https://www.mwe.com/insights/dea-signals-extension-of-telemedicine-flexibilities-for-controlled-substance-prescribing-for-2026/

KEY MEDTECH NEWS

Experts: PCCPs can advance AI in combination products, be aware of state laws

  • A US Food and Drug Administration (FDA) official said that predetermined change control plans (PCCPs), while not required, can reduce the need to submit supplemental applications for medical devices and device-led combination products that incorporate artificial intelligence (AI).
  • Kathryn Drzewiecki, digital health policy team lead at the Center for Devices and Radiological Health (CDRH), updated attendees of the AFDO/RAPS Healthcare Products Collaborative Combination Products Summit on several recent guidances, including FDA’s guidances on PCCPs for medical devices and PCCPs for AI-enabled software functions, as well as its draft guidance on lifecycle management and marketing submissions for AI-enabled device software functions.
  • "This provision actually applies to all devices, so even though we're talking about it today in the context of maybe software or AI-enabled devices. Generally, it's applicable to devices, and it's applicable to pre-market approvals and 510(k) applications," she added.
  • Drzewiecki noted FDA has issued two PCCP guidances; a draft guidance that generally addresses PCCPs in medical devices and a final guidance on marketing submission recommendations for PCCPs for AI-enabled device software functions. She noted that while some of the guidances are only in draft form, the PCCP requirements are already in effect and self-executing, which means manufacturers can already submit their PCCPs for FDA approval and clearance.
  • Elaborating on the final guidance on PCCPs for AI-enabled device software function (DSF) guidance, Drzewiecki said that while PCCPs are not a requirement, sponsors can find them to be a helpful way to improve their products to avoid repeatedly submitting supplemental applications.
  • https://www.raps.org/news-and-articles/news-articles/2025/11/experts-pccps-can-advance-ai-in-combination-produc

KEY ACRONYMS

  • ACA = Affordable Care Act
  • AI = artificial intelligence
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • ClinROs = clinician-reported outcomes
  • CMS = Centers for Medicare & Medicaid Services
  • COAs = clinical outcome assessments
  • DEA = Drug Enforcement Administration
  • FDA = Food and Drug Administration
  • FTC = Federal Trade Commission
  • HHS = Department of Health and Human Services
  • NIH = National Institutes of Health
  • ObsROs = observer-reported outcomes
  • PBMs = pharmacy benefit managers
  • PCCPs = predetermined change control plans
  • PerfOs = performance outcomes
  • PFDD = patient-focused drug development
  • PROs = patient-reported outcomes
  • SNAP = Supplemental Nutrition Assistance Program

 

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