Blog | 2/13/2026

Sharp Strategy Spotlight: February 13, 2026

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 February 12, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

US allocates $5.9 billion for global HIV programs in spending bill

  • This week, President Donald Trump signed into law a $5.9 billion spending package aimed at supporting the global response to HIV/AIDS and global public health.
  • The signing of the appropriations bill was hailed by the Joint United Nations Programme on HIV/AIDS (UNAIDS) as providing life-saving support for millions of people across the globe.
  • “I thank President Trump and the US Congress for their continued commitment to HIV and global health,” UNAIDS Executive Director Winnie Byanyima, MS, said in a press release. The investment will “help to ensure that the global HIV response remains efficient, data-driven and delivers results.”
  • The bill allocates $4.6 billion for HIV support through the America First Global Health Strategy; $1.3 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria; and $45 million directly to UNAIDS.
  • Press: https://www.cidrap.umn.edu/hivaids/us-allocates-59-billion-global-hiv-programs-spending-bill

US participating in influenza vaccine meeting: WHO

  • The U.S. will participate in the World Health Organization’s (WHO) upcoming meeting on the composition of the influenza vaccine despite officially withdrawing from the global group last month.
  • The WHO will meet on Feb. 26 in Turkey to discuss the composition of the 2026-2027 flu vaccine for the northern hemisphere.
  • “The vaccine composition meeting will be taking place later this month. The U.S. will participate in that meeting as far as I understand,” Maria Van Kerkhove, interim director of the WHO’s Department of Epidemic and Pandemic Management, said in a press conference Wednesday.
  • Last month, the U.S. officially withdrew from the WHO following the end of the year-long process to exit the group.
  • https://thehill.com/policy/healthcare/5733751-us-who-flu-vaccine-meeting

KEY FEDERAL GOVERNMENT NEWS

Warren, Hawley introducing legislation to break up ‘Big Medicine’

  • Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.) are teaming up to “break up big medicine.”
  • The lawmakers introduced legislation to crack down on health care conglomerates that own multiple parts of the industry — including pharmacy benefit managers (PBMs), which act as a conduit between insurers and drug manufacturers, and pharmacies themselves.
  • Warren and Hawley’s “Break Up Big Medicine Act” proposes prohibiting parent companies from owning a medical provider or management services organization and a PBM or insurer. It also proposes prohibiting parent companies of prescription drug or medical device wholesalers from owning a medical provider or management services organization.
  • Press: https://thehill.com/policy/healthcare/5732189-break-up-big-medicine-act
  • Bill: https://www.warren.senate.gov/imo/media/doc/break_up_big_medicine_act.pdf

Warren Renews Bill to Rein in Private Equity in Health Care

  • Sen. Elizabeth Warren (D-Mass.) will reintroduce a bill cracking down on exploitative private equity practices in the health-care industry, with fellow Democrats as co-sponsors.
  • The Corporate Crimes Against Health Care Act, which will be reintroduced Wednesday, would create new criminal and civil penalties for executives and owners of health-care firms if their financial management leads to patient harm or the collapse of the provider.
  • Warren first introduced the bill in June 2024. The latest version includes co-sponsors Sen. Jeff Merkley (D-Ore.), Sen. Ed Markey (D-Mass.) Sen. Peter Welch (D-Vt.), and Sen. Richard Blumenthal (D-Conn.)
  • A companion bill will be introduced to the House by Rep. Maggie Goodlander (D-N.H.).
  • Press: https://news.bloomberglaw.com/bankruptcy-law/warren-renews-bill-to-rein-in-private-equity-in-health-care   (subscription required for full text)
  • Bill: https://www.warren.senate.gov/imo/media/doc/kel26113.pdf

CMS plans to roll back limits on nonstandard ACA plan options

CMS revives nursing home staffing campaign after scrapping 24-hour rule

  • CMS has republished a Notice of Funding Opportunity related to addressing nursing home staffing challenges.
  • The agency is again accepting applications to help fund financial incentives, such as loan repayment and stipends, to registered nurses and licensed practical nurses who work for three years in an eligible nursing home or state oversight agency.
  • The republished funding opportunity builds on a series of staffing-related investments and policy moves CMS has made over the past two years.
  • In April 2024, CMS committed to investing more than $75 million to increase nursing home staffing. In December 2024, the agency launched a Nursing Home Staffing Campaign, earmarking $20 million for eligible nursing homes to use toward student loan debt relief for registered nurses.
  • In September 2025, CMS Administrator Mehmet Oz, MD, said the agency would invest more than $75 million in what he at the time called a “new campaign” to address the nursing home staffing shortage.
  • In December, three months after the “new campaign” was announced, CMS repealed a core provision of its 2024 minimum staffing rule for long-term care facilities, citing recent federal court rulings and concerns over implementation. The agency withdrew the requirement that long-term care facilities maintain a registered nurse on site 24/7.
  • Press: https://www.beckershospitalreview.com/post-acute/cms-revives-nursing-home-staffing-campaign-after-scrapping-24-hour-rule
  • Notice: https://www.grants.gov/search-results-detail/361025

Updated PASTEUR Act reintroduced in Congress to boost antibiotic development

  • The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, reintroduced last week by five members of the US House of Representatives, aims to revitalize the antibiotic and antifungal development pipeline by changing how the federal [sic] pays for novel antimicrobials.
  • The bill was first introduced in Congress in 2020 and re-submitted in subsequent years but has never received a floor vote.
  • The legislation would create a payment model under which the federal government would sign a subscription-style contract with pharmaceutical companies that develop critically needed new antibiotics and antifungals.
  • The companies would receive fixed annual payments from the government, ranging from $75 million to $300 million per year, based on how innovative their product is, how much it contributes to patient care, and how beneficial it is for public health.
  • Press: https://www.cidrap.umn.edu/antimicrobial-stewardship/updated-pasteur-act-reintroduced-congress-boost-antibiotic-development
  • Bill: https://buddycarter.house.gov/UploadedFiles/PASTEUR_Act.pdf

Trust in CDC near pandemic-era low after vaccine schedule changes

  • In the weeks after the Trump administration reduced the number of recommended childhood vaccines for routine use, the public’s trust in the Centers for Disease Control and Prevention (CDC) remains at its lowest point, a new KFF Poll on Health Information and Trust finds.
  • Fewer than half (47%) now say that they trust the agency at least “a fair amount” to provide reliable vaccine information, similar to the share who said the same in September, but down more than 10 percentage points since the beginning of the second Trump administration, and continuing a downward trend first measured during the COVID-19 pandemic.
  • The recent decline reflects falling confidence among Democrats. Slightly more than half (55%) of Democrats now say they trust the CDC on vaccines, down from 64% September. About 4 in 10 Republicans say they trust the CDC for vaccine information, similar to the share who said the same a few months ago and in 2023, but fewer than half as many as said they trusted the CDC on the coronavirus back in 2020.
  • “Six years ago, 85% of Americans, and 90% of Republicans, trusted the CDC. Now less than half trust the CDC on vaccines,” KFF President and CEO Drew Altman said. “The wars over COVID, science, and vaccines have left the country without a trusted national voice on vaccines, and that trust will take time to restore.”
  • https://www.kff.org/health-information-trust/poll-trust-and-confidence-in-the-cdc-remain-at-low-point-after-changes-to-recommended-childhood-vaccines-more-say-the-changes-will-hurt-than-help-childrens-health/

Ranked: How each HHS subagency workforce has decreased

  • Across 17 HHS agencies, a subagency that researches the quality, safety and affordability of healthcare services experienced the sharpest reduction in its workforce over the past year, according to data from the U.S. Office of Personnel Management.
  • The Agency for Healthcare Research and Quality’s workforce declined 65%, from 298 employees in fiscal 2024 to 103 as of December 2025.
  • The AHRQ has developed dozens of tools and resources for the healthcare industry, including toolkits to improve the discharge process and reduce healthcare-associated infections, according to its website.
  • Throughout 2025 and 2026, the U.S. government has enacted multiple rounds of layoffs across HHS as part of an effort to dismiss 10,000 full-time employees.
  • The three largest HHS agencies by workforce — the CDC, FDA and National Institutes of Health — each experienced a workforce decline of about 20%, according to data from the U.S. Office of Personnel Management.
  • Press: https://www.beckershospitalreview.com/quality/public-health/ranked-how-each-hhs-subagency-workforce-has-decreased/
  • Data: https://data.opm.gov/explore-data/analytics/workforce-size-and-composition

HHS Is Making an AI Tool to Create Hypotheses About Vaccine Injury Claims

  • The US Department of Health and Human Services is developing a generative artificial intelligence tool to find patterns across data reported to a national vaccine monitoring database and to generate hypotheses on the negative effects of vaccines, according to an inventory released last week of all use cases the agency had for AI in 2025.
  • The tool has not yet been deployed, according to the HHS document, and an AI inventory report from the previous year shows that it has been in development since late 2023.
  • But experts worry that the predictions it generates could be used by Health and Human Services secretary Robert F. Kennedy Jr. to further his anti-vaccine agenda.
  • Press: https://www.wired.com/story/hhs-is-making-an-ai-tool-to-create-hypotheses-about-vaccine-injury-claims/
  • HHS Inventory: https://www.hhs.gov/programs/topic-sites/ai/use-cases/index.html

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

House panel subpoenas 8 health insurers

  • House Judiciary Committee Republicans have subpoenaed eight Affordable Care Act health insurers for documents as part of a widening investigation of potential fraud surrounding the use of premium subsidies in the individual market, Axios has learned.
  • Why it matters: Enhanced premium tax credits for ACA coverage expired on Jan. 1. But Republicans are pressing forward with their probe of the Obamacare market — and putting heat on the entire health insurance industry.
  • State of play: House Judiciary Chair Jim Jordan (R-Ohio) issued subpoenas on Monday to get health insurers to send lawmakers more information on their subsidized ACA enrollees and discussions on subsidy-related fraud, the committee told Axios.
    • Jordan issued subpoenas to Elevance, CVS, Centene, GuideWell, Oscar Health, Kaiser Permanente, Health Care Service Corporation and Blue Shield of California.
    • The insurers must send the requested information to the House Judiciary Committee by Feb. 23, according to subpoenas viewed by Axios.
    • CVS told Axios that it has received the letter and is cooperating. HCSC said it's committed to deterring fraud in the health system and works with officials on program integrity. Centene said it's providing information with the goal of fighting fraud and increasing access.
    • Blue Shield of California said it's worked in good faith with the Judiciary Committee and already provided multiple responses, including data showing no evidence of phantom enrollees. The insurer continues to comply with the committee's request, it told Axios.
  • https://www.axios.com/2026/02/10/house-gop-republicans-aca-health-insurance-fraud   (subscription required for full text)

Four states sue Trump administration over cuts to public health funding

  • Four Democratic-led states filed a lawsuit on Wednesday that seeks to block the Trump administration from terminating $600 million in public health funding.
  • In a complaint ​filed in federal court in Chicago, the states — California, ‌Colorado, Illinois, and Minnesota — said they were being unlawfully subjected to “devastating funding cuts to basic public health infrastructure based on political animus and disagreements about unrelated topics such as federal immigration enforcement.”
  • A spokesperson for the U.S. Department of Health ‌and ​Human Services said on Monday that the ⁠grants are being terminated because ⁠they do not reflect the agency’s priorities. HHS did not immediately respond to a request for comment on the lawsuit.
  • The grant funding, administered through the Centers for Disease Control and Prevention, ​is used to monitor health threats, respond to disease outbreaks, and plan for public health emergencies. The affected programs include those ⁠supporting HIV prevention and surveillance.
  • Lawsuit Press: https://kfgo.com/2026/02/11/four-states-sue-trump-administration-over-cuts-to-public-health-funding/
  • Funding Cut Press: https://www.nytimes.com/2026/02/09/health/trump-public-health-cuts-california.html   (subscription required for full text)

Amicus brief filed against RFK Jr attacks ‘shared clinical decision-making’

KEY BIOPHARMA NEWS

Following legal setbacks, HHS agrees to toss 340B Rebate Model Pilot Program

  • The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals.
  • Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand.
  • The filing acknowledged the preliminary injunction plaintiffs had secured and the government's failed bid to have the temporary pause overturned by the appellate court. Both reflected judges' belief that the hospitals were likely to succeed on the merits of their claims based on at least two administrative issues—"a failure to provide a reasonable explanation or address significant reliance interests and a failure to consider relevant costs."
  • As such, HHS does not believe providing more administrative documents to the court would change any decisions, according to the joint motion.
  • The 340B program was enacted by Congress over 30 years ago to help subsidize safety-net care providers by manufacturer discounts on most drugs administered in the outpatient setting by covered entities.
  • HHS' pilot program would have swapped out upfront discounts for drugs purchased by participating hospitals for after-the-fact rebates for some products, as distributed by nine drugmakers who applied to participate in the one-year trial.
  • https://www.fiercehealthcare.com/providers/hospital-groups-file-lawsuit-enjoin-pharma-supported-340b-rebate-pilot

Trump administration revives effort to launch pilot initiative reworking drug discount program

  • File this under “If at first you don’t succeed…”
  • The Trump administration is planning another attempt at creating a pilot program that would alter payments for medicines purchased through a controversial federal drug discount program.
  • In a little-noticed posting, the Health Resources and Services Administration indicated it is pursuing a rule for a rebate model, although details were not disclosed.
  • A previously proposed pilot program would have allowed drugmakers to offer rebates to hospitals after a medicine is dispensed, instead of providing discounts at the time of purchase.
  • Press: https://www.statnews.com/pharmalot/2026/02/10/trump-340b-hospitals-pilot-pharma-medicines-rebate/   (subscription required for full text)
  • HRSA posting: https://www.reginfo.gov/public/do/eoDetails?rrid=1272015

Over 50 conservative leaders sign letter against Trump drug pricing policy codification

  • A coalition of more than 50 leaders of conservative and free-market organizations signed onto a letter to members of Congress on Thursday, opposing codifying President Trump’s “most favored nation” (MFN) drug pricing policy model into law.
  • The letter, which argues an MFN pricing law would “import socialist price controls and values into our country,” highlights the growing tension between Trump and a portion of the conservative movement.
  • The letter to lawmakers argued that a belief that MFN drug pricing would incentivize manufacturers to negotiate better deals is “based on the flawed assumption that American manufacturers are not already fighting as hard as they can against foreign price controls.”
  • The signatories argue that there could be unintended negative consequences from the price controls.
  • https://thehill.com/policy/healthcare/5734862-conservative-leaders-oppose-trump-drug-pricing-policy/

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

CDC Traveler-Based Genomic Surveillance Program Tops One Million Participants, Giving Clinical Labs Earlier Warning on Emerging Variants

  • The CDC announced that its Traveler-Based Genomic Surveillance (TGS) program has surpassed one million voluntary participants, marking a significant expansion of the nation’s upstream pathogen surveillance infrastructure.
  • For clinical, molecular, and public health laboratories, the milestone highlights how border-based genomic monitoring is increasingly being used to identify emerging variants before they appear in community testing or hospital admissions.
  • Launched in 2021, TGS collects anonymous nasal swabs from arriving international travelers at select U.S. airports and complements this data with aircraft wastewater sampling.
  • Sequencing and analysis are conducted through public-private partnerships with companies such as Ginkgo Biosecurity and XWell, allowing the CDC to generate actionable genomic data even when testing and sequencing capacity may be limited in other parts of the world.
  • https://www.darkdaily.com/2026/02/09/cdc-traveler-based-genomic-surveillance-program-tops-one-million-participants-giving-clinical-labs-earlier-warning-on-emerging-variants/

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Virtual diabetes prevention programs secure Medicare coverage

  • In the $1.2 trillion budget package signed Tuesday, a little-known healthcare provision was reauthorized that will allow millions of people on Medicare to access diabetes prevention education online.
  • As part of the budget package, Congress passed the PREVENT DIABETES Act, which extends the ability for digital health companies (virtual suppliers) to participate in the Medicare Diabetes Prevention Program (MDPP) through the end of 2029.
  • Medicare Part B patients who are at risk for Type 2 diabetes can participate in the program for free, if they meet certain clinical thresholds for weight, blood pressure or blood glucose.
  • The program lasts for a year and consists of 22 sessions on lifestyle changes to prevent diabetes.
  • https://www.fiercehealthcare.com/digital-health/virtual-diabetes-prevention-programs-secure-medicare-coverage

500M records exchanged through TEFCA, federal health IT office boasts

  • Nearly five hundred million records have been exchanged through the Trusted Exchange Framework and Common Agreement (TEFCA), up by a jaw-dropping 4,900% since Jan. 2025, the Department of Health and Human Services’ health IT office announced on Wednesday.
  • Tom Keane, M.D., the assistant secretary of technology policy and national coordinator of health IT (ASTP/ONC), made the announcement on Wednesday morning at the ASTP/ONC 2026 Annual Meeting.
  • TEFCA is the government-backed health data-sharing initiative that allows patients, providers and payers to share health records. It went live in December 2023.
  • In addition to the massive spike in records exchanged through TEFCA, Keane announced that his office has begun sending out information-blocking notices to certain developers of certified health IT to explain potential issues with compliance.
  • Keane also touted regulatory updates the ASTP/ONC produced in 2025. The HTI-4 final ruleset [sic] standards for electronic prior authorizations and real-time prescription benefits for health IT products certified by the office.
  • The health IT office also released a proposed rule in late December, HTI-5, which guts 34 out of 60 standards for health IT. In the rule, the ASTP/ONC called the requirements redundant and outdated and estimates that it will save developers $1.53 billion in compliance costs.
  • https://www.fiercehealthcare.com/health-tech/500m-records-exchanged-through-tefca-federal-health-it-office-boasts

SAMHSA and HHS announce behavioral health data exchange pilots

  • The Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services' Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health IT (ASTP/ONC) have named nine pilot sites that will begin testing the USCDI Behavioral Health dataset and data exchange through the FHIR Behavioral Health Profiles Implementation Guide in real-world health settings.
  • Sites in Colorado, Connecticut, Delaware, Florida, Massachusetts, North Carolina, Oregon, Rhode Island and Washington, D.C., will use awards ranging from $300,000 to $690,000 to implement provider-informed, community-driven projects that address interoperability, privacy, consent and other Confidentiality of Substance Use Disorder Patient Record requirements.
  • As part of SAMHSA's $20 million Behavioral Health Information Technology, 45 exchange partners across the nine pilot states will test data exchange with the behavioral health-specific data elements – USCDI+ BH – which were co-developed by the agency and ASTP/ONC.
  • The goal of the USCDI+ BH standards is to improve and reduce the costs of data capture, use and exchange for behavioral health providers.
  • The projects will test integrations with health information exchanges, how data can support referrals for community‑based housing and vocational resources, and more.
  • https://www.healthcareitnews.com/news/samhsa-and-hhs-announce-behavioral-health-data-exchange-pilots

KEY MEDTECH NEWS

MDUFA VI: Industry seeks changes to de novo, pre-submission programs

  • Medical device industry groups are proposing changes to the US Food and Drug Administration's (FDA) de novo and its pre-submission programs to improve their efficiency. Additionally, these groups are seeking more information about how the agency plans to use user fees to fund its real-world evidence (RWE) program. They are specifically requesting details regarding the full-time equivalents (FTEs) involved in this initiative.
  • These comments and recommendations were raised by industry during negotiations to renew the Medical Device User Fee Amendments (MDUFA VI) program for fiscal years 2028 to 2032. These proposals were mentioned in the meeting minutes from the MDUFA discussions held with industry representatives on 21 January. The current user fee program for devices will expire on 30 September 2027.
  • The meeting included representatives from the FDA’s Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), the FDA’s Office of the Chief Counsel (OCC), and consultants to FDA.
  • Representatives from the Advanced Medical Technology Association (AdvaMed), GE Healthcare, the Medical Device Manufacturers Association (MDMA), Medtronic, Boston Scientific, Siemens Healthineers, and Cook Medical were present from the industry.
  • At the meeting, FDA and industry presented proposals for the de novo and pre-submission programs and provided readouts from their working groups on areas of agreement and disagreement.
  • https://www.raps.org/news-and-articles/news-articles/2026/2/mdufa-vi-industry-seeks-changes-to-de-novo,-pre-su

KEY ACRONYMS

  • AAP = American Academy of Pediatrics
  • ACA = Affordable Care Act
  • AHA = American Hospital Association
  • AHRQ = Agency for Healthcare Research and Quality
  • ASTP/ONC = Assistant Secretary for Technology Policy/Office of the National Coordinator
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • CMS = Centers for Medicare & Medicaid Services
  • DHS = Department of Homeland Security
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • NIH = National Institutes of Health
  • OCC = Office of the Chief Counsel (FDA)
  • MDPP = Medicare Diabetes Prevention Program
  • MDUFA = Medical Device User Fee Amendments
  • MFN = most favored nation
  • NSRP = National Security, Department of State and Related Programs
  • PASTEUR = Pioneering Antimicrobial Subscriptions to End Upsurging Resistance
  • PBM = pharmacy benefit manager
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • TEFCA = Trusted Exchange Framework and Common Agreement
  • TGS = Traveler-Based Genomic Surveillance
  • UNAIDS = Joint United Nations Programme on HIV/AIDS
  • WHO = World Health Organization

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