Blog | 9/12/2025

Sharp Strategy Spotlight: September 12, 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 September 11, 2025.   All words/analysis are those from the source noted; all sources are in the public domain so content may be shared with clients.  Please know that many topics remain fluid even as this email is sent.

KEY HEALTH NEWS (Global)

The US will buy 2 million doses of an HIV prevention drug for low-income countries

  • The U.S. is purchasing enough doses of a new twice-a-year HIV prevention shot to share with up to 2 million people in poor countries by 2028, the State Department announced Thursday.
  • Gilead Sciences had already announced it would sell that supply of the protective drug lenacapvir at no profit for use in low- and middle-income countries that are hard-hit by HIV.
  • The question was who would buy and distribute them after the Trump administration slashed foreign aid earlier this year – forcing closures of health clinics and disrupting HIV testing and care in many countries.
  • The U.S. will purchase the doses under the PEPFAR program and work with governments in hard-hit countries on how to distribute them. The priority will be to protect pregnant or breastfeeding women, said Jeremy Lewin, a State department senior official.
  • https://apnews.com/article/hiv-prevention-lenacapavir-trump-pepfar-e85c9b8772141722fccc4b7b349ef809

KEY FEDERAL GOVERNMENT NEWS

MAHA strategy released: Targets vaccines, chronic disease, childhood nutrition

  • The Trump administration released a new strategy report for how it plans to implement its efforts to “Make America Healthy Again” (MAHA), seeking to make changes to vaccines but sidestepping calls to regulate pesticides and toxic chemicals.
  • The strategy report builds upon a previous report outlining what the administration sees as threats to public health, talking about how it will implement a vision largely driven by Health and Human Services (HHS) Secretary Robert. F. Kennedy Jr.
  • In particular, it seeks policy action on vaccines, setting up a “vaccine framework” to be developed by the White House Domestic Policy Council and Kennedy’s department. The framework will include ensuring “the best childhood vaccine schedule”; addressing vaccine injuries; “modernizing” American vaccines; ensuring “scientific and medical freedom”; and “correcting conflicts of interest and misaligned incentives.”
  • Press: https://thehill.com/policy/healthcare/5494225-trump-health-strategy-report/
  • HHS Press: https://www.hhs.gov/press-room/maha-commission-report-childhood-disease-strategy.html
  • MAHA Report: https://www.whitehouse.gov/maha/

House Appropriators Allow BARDA mRNA Research, Move To Defund WisER In HHS Spending Bill

CDC Infectious Disease Data Project Shelved

  • HHS has put on ice a CDC project that would make information about dozens of diseases available in near real time, CDC sources told MedPage Today.
  • Since early summer, the team has been working on a more user-friendly website that would make case counts on 127 notifiable conditions available in one place, alongside expert commentary.
  • But when they asked for approval to launch it, HHS put it on hold indefinitely, several sources said.
  • Debra Houry, MD, MPH, who recently resigned as the agency's chief medical officer, confirmed that the project was put on hold.
  • Two other CDC scientists who requested anonymity described the project as a one-stop-shop for all notifiable conditions, searchable by state. A public health official in New Jersey, for instance, would be able to see case counts for all notifiable conditions in their state and which way cases were trending.
  • Currently, it's hard for public health officials to monitor this information comprehensively, one of those scientists told MedPage Today.
  • The data are collected through the National Notifiable Diseases Surveillance System and provisional data are reported weekly, the sources said, adding that there are no new data flows for the project. "What's new is the design and the delivery to the public," one explained.
  • https://www.medpagetoday.com/special-reports/exclusives/117385

Trump signs order offering some tariff exemptions to countries with US trade deals

CMS issues guidance on limits for state-directed payments in Medicaid

  • The Centers for Medicare & Medicaid Services (CMS) said it chose to issue the guidance ahead of final rulemaking to give states additional time to adjust to changes under the One Big Beautiful Bill Act. The new guidelines will take effect for rating periods after July 4, 2025.
  • The guidance says SDPs for inpatient and outpatient hospital care, skilled nursing and services from a qualified practitioner must be capped at 100% of Medicare rates in states that expanded Medicaid and 110% in non-expansion states.
  • If a Medicare rate is unavailable, the payments will be based on state Medicaid rates, per the CMS.
  • The agency said certain eligible payments submitted either on or before the July 4 deadline may be grandfathered through rating periods beginning Jan. 1, 2028, and then be under a phased-in approach until the new limitations are met.
  • For states, the next step is to revise SDPs that will not qualify for the grandfathered period to comply with the guidance. The CMS said it will notify states as to whether certain payments qualify for grandfathering in its review process.
  • https://www.fiercehealthcare.com/regulatory/cms-issues-guidance-limits-state-directed-payments-medicaid

CMS pauses MA supplemental benefit notification rule

  • CMS is delaying a Medicare Advantage supplement benefits notification rule that was slated to start in 2026. The pause affects MA organizations that would have sent annual notifications between June 30 and July 31 to enrollees about unused benefits, according to a Sept. 8 CMS notice to insurers.
  • Some MA organizations had requested further guidance from CMS on implementation of the policy, which was included in the 2025 MA final rule. These concerns prompted a temporary pause, effective immediately.
  • A study from early 2025 found only 54% of MA beneficiaries knew they had dental and vision coverage, prompting concerns as to why these enrollees were not using their supplemental benefits.
  • https://www.beckerspayer.com/payer/medicare-advantage/cms-pauses-ma-supplemental-benefit-notification-rule/

FDA chief details ‘intense investigation’ into alleged child deaths from Covid-19 shots

  • FDA chief Marty Makary said the agency is investigating whether the Covid-19 vaccines caused any deaths in kids, building on the government’s monthslong effort to question the safety of the products.
  • In an interview on CNN, Makary described the probe as an “intense investigation.” The FDA is relying on self-reported cases to the CDC’s Vaccine Adverse Event Reporting System (VAERS), Makary said. He added that the agency is following up with the parents of children claimed to have been killed, reviewing autopsy reports, and asking physicians to examine the data.
  • Adverse events reported to VAERS alone are not indicative of a vaccine causing a particular side effect.

KEY BIOPHARMA NEWS

Trump carves out generics from 15% tariffs in US-Japan trade deal

Trump signs order to crack down on prescription drug advertising

Trump may exempt some pharma products from tariffs in future trade deals

  • President Donald Trump is looking to strike more deals with trade partners and says he “may be willing” to exempt some pharmaceutical products from future tariffs.
  • An executive order released last week establishes a new list of products, dubbed Annex III, that could face a 0% reciprocal tariff rate depending on the deal. Items listed under Annex III include an array of pharmaceutical products such as cell therapies, certain vaccines, antibiotics and other chemicals and hormones.
  • The Friday order defined the pharma products listed under Annex III as “non-patented articles for use in pharmaceutical applications.”
  • Yet no further details were given, suggesting that branded drugs with expired patents could be exempted from tariffs if they fall under the Annex III list. Alternatively, the administration could simply be defining generic pharmaceuticals as “non-patented” drugs, Mollie Sitkowski, a trade compliance partner at US law firm Faegre Drinker, told Endpoints News. 
  • The order also doesn’t say whether there will be different exemptions for general, patented pharma products. The implementation of Annex III tariffs is likely to vary from country to country depending on each trade deal, Sitkowski said.
  • https://endpoints.news/trump-may-exempt-some-pharma-products-from-tariffs-in-future-trade-deals/   (subscription required for full text)

More than 160 bipartisan lawmakers tell HHS to scrap 340B rebate pilot

  • A bipartisan group of 163 lawmakers is urging the Department of Health and Human Services (HHS) to cancel an upcoming pilot of after-the-fact rebates for drugs hospitals purchase through the 340B Drug Discount Program—or to at least provide more information on how it intends to shield hospitals and the government itself from additional administrative costs and burdens.
  • The letter, dated Sept. 8, lands as hospital and drugmaker lobbying groups grapple over the controversial rebates ahead of the pilot’s application deadline and a new Congressional Budget Office (CBO) analysis detailing the scale and causes of the drug subsidy program’s substantial growth.
  • “Congress intended the 340B Program to enable the nation’s safety-net providers to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services,” the lawmakers wrote. “An unchecked rebate model would severely undermine that purpose.”
  • The HHS and the Health Resources and Services Administration’s (HRSA’s) one-year test run was announced in late July, with applications from drugmakers due Sept. 15 and the whole program set to begin Jan. 1. It will require hospitals eligible for the discounts to purchase a subset of drugs (those on the Medicare Drug Price Negotiation Selected Drug List) at their wholesale cost and file with the manufacturer for a rebate.
  • https://www.fiercehealthcare.com/regulatory/163-bipartisan-lawmakers-tell-hhs-scrap-340b-rebate-pilot

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

HHS OIG Calls for Mandatory Public Health Emergency Plans by Diagnostic Labs

Congress Introduces New Legislation to Reform Protecting Access to Medicare Act

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA will convene Digital Health Advisory Committee in November

  • The Food and Drug Administration will convene a meeting of external digital health advisors on Nov. 6, according to an email reviewed by STAT. The gathering comes as the agency wrestles with myriad issues related to regulating artificial intelligence and other technologies in health care.
  • The email, addressed to members of and consultants to the FDA’s Digital Health Advisory Committee, said the virtual-only meeting would be announced publicly no later than Sept. 10. No topic was given, but the email said an agenda and discussion questions were forthcoming.
  • Another source involved with the committee told STAT they had not been notified of the meeting. The FDA did not immediately respond to a request for comment.
  • https://www.statnews.com/2025/09/05/fda-digital-health-advisory-committee-november-meeting/    (subscription required for full text)

KEY MEDTECH NEWS

No significant news items this week.

IMPORTANT INTERNAL SOURCES

  • TAN Tracker
    • list of key resources for tracking news
    • link to the political appointee tracker

KEY ACRONYMS

  • ASTP/ONC = Assistant Secretary for Technology Policy/Office of the National Coordinator
  • CBER = Center for Biologics Evaluation and Research
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  • NIH = National Institutes of Health
  • OIG = Office of Inspector General
  • PEPFAR = President's Emergency Plan for AIDS Relief
  • SPDs = state directed payments
  • VAERS = Vaccine Adverse Events Reporting
  • WISeR = Wasteful and Inappropriate Service Reduction

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