Holiday Weekend Update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Holiday Weekend Update

David Ermer–Congress, Medical / Rx research, Medicare, Obesity, SCOTUS, U.S. Healthcare–

Happy Presidents’s Day!

  • Congress is on recess this week unless a bipartisan settlement over the issues causing the Department of Homeland Security shutdown is reached midweek.
  • On Friday February 20, 2026, the U.S. Supreme Court may announce opinions, which are posted on the homepage after announcement from the Bench.
  • STAT News reports,
    • “The Medicare Advantage program continues to bring in more older adults and people with disabilities, but not nearly at the same rates from just a few years ago.
    • “Almost 35.5 million people were enrolled in a Medicare Advantage plan as of Feb. 1, up roughly 3% from 34.4 million at the same time in 2025, according to new federal data analyzed by STAT. The growth during Medicare’s annual enrollment window, which runs from Oct. 15 through Dec. 7, stagnated — with enrollment increasing just 1%.
    • “By comparison, annual enrollment growth in Medicare Advantage ranged between 7% and 10% between 2017 and 2024, according to historical data analysis by STAT.”
  • Federal News Network interviews Jonathan Smith, the new President of the American Postal Workers Union. “Smith started his leadership role last November. He’s been a member of APWU since 1988, and previously served as president of APWU’s largest local, the New York Metro Area Postal Union.”

From the public health and medical / Rx research front,

  • Insurance News Net reports,
    • “According to MetLife research, less than half of America’s workforce is holistically healthy, as employees battle rising costs and employers balance investing in benefits with broader cost-cutting measures. These early findings from MetLife’s 2026 U.S. Employee Benefit Trends Study (EBTS) underscore the challenge of sustaining workforce well-being and engagement in an environment in which employees and employers are financially strained, the report said.
    • “MetLife’s EBTS defines holistic health as a combination of physical, mental, financial and social health.
    • “Highlights of the study include:
      • “83% of employees said that rising living expenses and medical costs are their top stressors and 77% said that economic uncertainty is a major concern.
      • “On average, employees miss 6.1 days of work because of health-related issues and 50% of key employees often avoid seeking medical care because of out-of-pocket costs.
      • “Employers cited “controlling health care costs” as the #1 benefits objective. This surpasses productivity, loyalty, and attracts new talent for the first time since 2022.
      • “60% of employers increased their investment in benefits and 62% expanded their non-medical offerings.
      • ‘As overall workforce well-being has stalled, with just 44% of employees report feeling holistic healthy and engagement, loyalty and productivity remain flat.”
  • NBC News relates,
    • “The recent death of the 48-year-old actor James Van Der Beek is again highlighting how colorectal cancer is increasingly killing younger people.”
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Overall, cancer death rates in people younger than 50 have dropped by 44% since 1990. But after increasing for decades, colorectal cancer is now the leading cause of cancer death in people under 50. Colorectal cancer starts either in the colon or rectum. 
    • “Federal cancer screening guidelines and the American Cancer Society recommend that people who have an average risk for colorectal cancer should begin screening at age 45 with a colonoscopy every 10 years, or a stool test every one to three years. Insurance companies use the guidelines to determine whether the screening is covered.” * * *
    • “It’s clear that colorectal cancer rates are rising among young people, but the cause is still poorly understood.
    • “Research suggests that rising rates of obesity and declining physical activity, changes in the gut microbiome and diets high in ultraprocessed foods, which have become more common since the 1980s, are largely to blame. Some early research has also suggested that antibiotic use and having certain bacteria in the gut could also play a role. 
    • Dr. Andrew Chan, a gastroenterologist and chief of the clinical and translational epidemiology unit at Mass General Brigham in Boston “said that while screening is important, people should also focus on improving their diet and getting enough exercise, two lifestyle factors that have been shown to significantly reduce a person’s risk of colorectal cancer. 
    • “Those types of interventions will hopefully have benefits that extend beyond screening,” he said. “Screening is important, but I don’t want us to ignore those other factors.”
  • The American Medical Association lets us know “what doctors wish patients knew about stress management.”
    • “Whether it is using a stress ball or practicing yoga, stress relief is key. Brian Chaney, MD, of Baptist Health, offers tips for relief from stress.”
  • Per MedPage Today,
    • “Lifelong intellectual activity, such as reading or museum visits, was tied to lower Alzheimer’s dementia risk in older adults.
    • “Adults with the highest level of cognitive enrichment developed mild cognitive impairment about 7 years later than others.
    • “Results persisted even after adjusting for Alzheimer’s pathology, suggesting strong cognitive resilience.”
  • and
    • “Adherence to one of five healthy diets was tied to lower mortality risk and added up to 3 years to lifespan.
    • “Associations remained robust regardless of genetic predisposition for longevity.
    • “Diet focused on reducing diabetes risk showed the strongest link with lower death risk.”
  • Cardiovascular Business tells us,
    • “Childhood obesity is associated with a significant risk of vascular damage, according to a new study of children between the ages of six and 11 years old. Researchers hope these findings make it clear just how important it is to prevent childhood obesity and encourage young children—with help from their families—to make healthy eating choices.
    • ‘The new analysis, published in the International Journal of Obesity, focused on 113 children who were categorized as either having a healthy weight or being overweight/obese. Each child was assessed using peripheral arterial tonometry. Overall, overweight and obese children performed worse on the reactive hyperemia index, a measurement of endothelial function. These children also had higher TNF-alpha gene expression and elevated levels of endothelial microparticles, which are both signs of vascular inflammation. Such inflammation has a long-term impact on the body, causing immune cells to age prematurely and doing permanent damage.
    • “The results of the study reinforce the seriousness of childhood obesity, showing that it needs to be reversed early on. We also warn about the need for public policies to reduce obesity in childhood, especially in socioeconomically vulnerable populations,” senior author Maria do Carmo Pinho Franco, a professor at the Federal University of São Paulo in Brazil, said in a statement.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports,
    • “Humana completed its acquisition of the primary care clinic operator MaxHealth from private equity firm Arsenal Capital Partners.
    • “The deal adds 54 primary care clinics, four specialty sites and 24 affiliated facilities to Humana’s CenterWell healthcare services arm.
    • “The companies did not disclose financial details of the acquisition, and Humana declined to comment.
    • “Related: Humana is said to be near $1B deal for MaxHealth
    • “Tampa, Florida-headquartered MaxHealth counts more than 120,000 Medicare and Medicaid patients as customers, according to a Friday news release.”
  • Cardiovasular Business informs us,
    • “Boston Scientific has agreed to acquire Penumbra, a California-based medtech company focused on vascular technologies, for approximately $14.5 billion. This is a cash and stock transaction that values Penumbra at $374 per share.
    • “Penumbra is known for its mechanical thrombectomy devices, including those used to perform peripheral vascular disease treatments, and a variety of offerings in the neurovascular space. The company, founded in 2004, currently has more than 4,500 employees and expects its 2025 revenue to total approximately $1.4 billion. That figure represents growth of more than 17% compared to the previous year. 
    • “Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” Mike Mahoney, chairman and CEO of Boston Scientific, said in a prepared statement. “I’m thrilled to combine the talents and shared values of our teams—including welcoming Penumbra’s chairman and chief executive officer, Adam Elsesser, to our board of directors upon close. The addition of Penumbra can expand access for these novel technologies to more patients and customers around the world, further enhancing our revenue and margins over time with proven offerings that have a history of growth and innovation.”
  • The Wall Street Journal discusses the signficance of the movement towards direct to consumer sales of GLP-1 drugs.
    • “Ro, a competitor to Hims, points to a different path. Rather than leaning on legally murky, high-margin compounded drugs, Ro acts as a telehealth gateway for branded medications. Ro also sold compounded GLP-1s during the shortages, but both Eli Lillyand Novo Nordisk now sell their drugs on the platform. As CEO Zach Reitano explains: “Too many problems in our healthcare system exist because the patient does not control the flow of money at the point of purchase,” he says. “When they do, the system rewires itself.”
  • Beckers Hospital Review ranks physicians assistants’ pay by State.
    • “Compensation for physician assistants varies widely by state, with California reporting the highest mean PA income in 2024 at $151,351, according to the National Commission on Certification of Physician Assistants’ 2024 Statistical Profile of Board Certified PAs by State.
    • “Nationally, the mean PA income was $129,291.
    • ‘The data, released Feb. 12, reflect responses from PAs who were board certified as of Dec. 31, 2024. Income figures are based on PAs’ state of residence and reflect total income from all PA positions combined for the most recent calendar year reported by respondents. Midpoints of income ranges were used to calculate mean and median values.”
  • MedCity News observes,
    • “Health informatics leaders at NYU Langone Health think fully autonomous clinical AI is coming in the next five years or so, with algorithms soon able to manage routine tasks like blood pressure medication titration and diabetic retinopathy screening without human oversight. They argue automation is not just about efficiency, but also a practical and necessary solution to workforce shortages and system inefficiencies.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

  • Per a February 11, 2026, Cybersecurity and Infrastucture Security Agency news release,
    • “The Cybersecurity and Infrastructure Security Agency (CISA) unveiled its 2025 Year in Review today, spotlighting bold achievements that strengthened the nation’s cyber and physical security in 2025. The report underscores CISA’s commitment to innovation, resilience, and collaboration. This report is a snapshot of goals achieved for this past year. Year over year CISA’s goals change as the threat landscape evolves and as we lean into core mission objectives as determined by the Administration’s policies. 
    • “The Year in Review is more than a report – it’s proof of CISA’s unwavering commitment to protecting the infrastructure and systems Americans count on every day,” said CISA Acting Director Madhu Gottumukkala. “From safeguarding federal networks to equipping communities with tools to reduce risk, our team delivered measurable results in 2025. And we’re not slowing down – we will lead with innovation, resilience and partnership to stay ahead of tomorrow’s threats.”
  • Federal News Network reports,
    • “Sen. Ron Wyden (D-Ore.) is pledging to keep his hold on the nominee to lead the Cybersecurity and Infrastructure Security Agency. Wyden said he will continue to object to Sean Plankey’s nomination until CISA releases a 2022 report on security flaws in the U.S. telecommunications system. Wyden previously held up Plankey’s nomination for much of last year over the same issue. (Sen. Ron Wyden (D-Ore.) floor remarks – Congress.gov)”
  • Cyberscoop tells us,
    • “A recent attempt at a destructive cyberattack on Poland’s power grid has prompted the Cybersecurity and Infrastructure Security Agency to publish a warning for U.S. critical infrastructure owners and operators.
    • “Tuesday’s alert follows a Jan. 30 report from Poland’s Computer Emergency Response Team concluded the December attack overlapped significantly with infrastructure used by a Russian government-linked hacking group, and that it targeted 30 wind and photovoltaic farms, among others.
    • “CISA said its warning was meant to “amplify” that Polish report. In particular, CISA said the attack highlighted the threats to operational technology and industrial control systems, most commonly used in the energy and manufacturing sectors.
    • ‘And CISA’s alert continues a recent agency focus on securing edge devices like routers or firewalls, after a binding operational directive last week to federal agencies to strip unsupported products from their systems.”
  • Cybersecurity Dive relates,
    • “The Cybersecurity and Infrastructure Security Agency wants critical infrastructure partners’ feedback on the scope of its cyber-incident reporting regulation as the agency homes in on a final version of the long-awaited rule.
    • “In a notice set for publication in the Federal Register on Friday [January 13], CISA announced a series of town hall meetings where different sectors will be able to share their thoughts about the pending rule, which Congress required in the 2022 Cyber Incident Reporting for Critical Infrastructure Act.
    • “A draft version of the CIRCIA rule, published in April 2024, gave covered infrastructure operators 72 hours to report substantial cyber incidents to the government. Business groups and some lawmakers objected to the scope of the information that companies would need to report, as well as to the breadth of companies covered under the regulation.
    • “In its new announcement, CISA said it “appreciates stakeholders’ interest and concern that CISA implement CIRCIA to maximize its impact on improving our nation’s cybersecurity posture while minimizing unnecessary burden to entities in critical infrastructure sectors.”
    • “The agency wants infrastructure operators to share “specific, actionable improvements” to CIRCIA that “clarify or reduce” the burden of the planned reporting requirement while still giving the government ample information about the cyber-threat landscape.”
    • The virtual town hall meeting for the Emergency Services Sector, Government Facilities Sector, Healthcare and Public Health Sector is scheduled for March 17, 2026.
  • Federal News Network reports,
    • “The Cybersecurity and Infrastructure Security Agency plans to designate 888 of its 2,341 employees as excepted during a shutdown. All of those employees would go without pay during a shutdown.
    • “A shutdown forces many of our frontline security experts and threat hunters to work without pay— even as nation-states and criminal organizations intensify efforts to exploit critical systems that Americans rely on—placing an unprecedented strain on our national defenses,” Acting CISA Director Madhu Gottumukkala toldlawmakers this week.
    • “The cyber agency’s core responsibilities include defending federal agency networks and working with critical infrastructure to strengthen their security.
    • “Gottumukkala said that a shutdown would delay the deployment of new cyber services to federal networks and the sharing of guidance with critical infrastructure partners. It would also likely delay CISA’s work to finalize a landmark cyber incident reporting rule.“

From the cybersecurity vulnerabilities and breaches front,

  • CISA added eleven known exploited vulnerabilities to its catalog this week.
    • February 10, 2026
      • CVE-2026-21510 Microsoft Windows Shell Protection Mechanism Failure Vulnerability
      • CVE-2026-21513 Microsoft MSHTML Framework Security Feature Bypass Vulnerability
      • CVE-2026-21514 Microsoft Office Word Reliance on Untrusted Inputs in a Security Decision Vulnerability
      • CVE-2026-21519 Microsoft Windows Type Confusion Vulnerability
      • CVE-2026-21525 Microsoft Windows NULL Pointer Dereference Vulnerability
      • CVE-2026-21533 Windows Remote Desktop Services Elevation of Privilege Vulnerability
        • SecPod discusses these KVEs here. 
    • February 12, 2026
      • CVE-2024-43468 Microsoft Configuration Manager SQL Injection Vulnerability
      • CVE-2025-15556 Notepad++ Download of Code Without Integrity Check Vulnerability
      • CVE-2025-40536 SolarWinds Web Help Desk Security Control Bypass Vulnerability
      • CVE-2026-20700 Apple Multiple Buffer Overflow Vulnerability
        • Nopsec discusses the MS Configuration KVE here.
        • WNEsecurity discusses the Notepad++ KVE here.
        • Rapid7 discusses the Solarwinds KVE here.
        • Bleeping Computer discusses the Apple KVE here.
    • February 13, 2026
      • CVE-2026-1731 BeyondTrust Remote Support (RS) and Privileged Remote Access (PRA) OS Command Injection Vulnerability
        • The Hacker News discusses this KVE here.
  • Cybersecurity Dive informs us,
    • “Security researchers warn that threat groups are exploiting critical vulnerabilities in SmarterMail, a business email and collaboration server that small to medium-sized businesses use as an alternative to Microsoft Exchange. 
    • “A China-linked threat actor, tracked as Storm 2603, has exploited an authentication bypass vulnerability tracked as CVE-2026-23760 to deploy Warlock ransomware, according to a blog released Monday by researchers at Reliaquest. 
    • “The hacker abuses legitimate administrative functions to hide its activity from security teams. It then installs a digital forensic tool called Velociraptor to maintain access in preparation for potential ransomware attacks, according to Reliaquest. 
    • “SmarterTools, the parent company behind SmarterMail, confirmed in a Feb. 3 blog post that its own network was impacted by a Jan. 29 breach.” 
  • and
    • “More than 80% of exploitation activity targeting critical vulnerabilities in Ivanti Endpoint Manager Mobile were traced to a single IP address hiding behind a bulletproof hosting infrastructure, according to a report released Tuesday by GreyNoise. 
    • Researchers warn that several of the most shared indicators of compromise linked to the current threat campaign indicate no activity linked to Ivanti EPMM. The concern is that security teams may therefore be looking for the wrong information, as current IoCs indicate scanning for Oracle WebLogic instead, according to GreyNoise researchers.”
  • Cyberscoop notes,
    • “A new report from Google found evidence that state-sponsored hacking groups have leveraged AI tool Gemini at nearly every stage of the cyber attack cycle.
    • “The research underscores how AI tools have matured in their cyber offensive capabilities, even as it doesn’t reveal novel or paradigm shifting uses of the technology.
    • J”ohn Hultquist, chief analyst at Google’s Threat Intelligence Group, told CyberScoop that many countries still appear to be experimenting with AI tools, determining where they best fit into the attack chain and provide more benefit than friction.
    • “Nobody’s got everything completely worked out,” Hultquist said. “They’re all trying to figure this out and that goes for attacks on AI, too.
    • “But the report also reveals that frontier AI models can build speed, scale and sophistication into a myriad of hacking tasks, and state-sponsored hacking groups are taking advantage.”
  • Bleeping Computer points out,
    • “Threat actors are abusing Claude artifacts and Google Ads in ClickFix campaigns that deliver infostealer malware to macOS users searching for specific queries.
    • “At least two variants of the malicious activity have been observed in the wild, and more than 10,000 users have accessed the content with dangerous instructions.
    • “A Claude artifact is content generated with Antropic’s LLM that has been made public by the author. It can be anything from instructions, guides, chunks of code, or other types of output that are isolated from the main chat and accessible to anyone via links hosted on the claude.ai domain.”
  • and
    • “A set of 30 malicious Chrome extensions that have been installed by more than 300,000 users are masquerading as AI assistants to steal credentials, email content, and browsing information.
    • “Some of the extensions are still present in the Chrome Web Store and have been installed by tens of thousands of users, while others show a small install count.
    • “Researchers at browser security platform LayerX discovered the malicious extension campaign and named it AiFrame. They found that all analyzed extensions are part of the same malicious effort as they communicate with infrastructure under a single domain, tapnetic[.]pro.”
  • and
    • “A new variation of the fake recruiter campaign from North Korean threat actors is targeting JavaScript and Python developers with cryptocurrency-related tasks.
    • “The activity has been ongoing since at least May 2025 and is characterized by modularity, which allows the threat actor to quickly resume it in case of partial compromise.
    • “The bad actor relies on packages published on the npm and PyPi registries that act as downloaders for a remote access trojan (RAT). In total, researchers found 192 malicious packages related to this campaign, which they dubbed ‘Graphalgo’.
    • “Researchers at software supply-chain security company ReversingLabs say that the threat actor creates fake companies in the blockchain and crypto-trading sectors and publishes job offerings on various platforms, like LinkedIn, Facebook, and Reddit.”
  • TechRadar advises
    • “If you’re using an older Android phone, Google has a message you probably don’t want to hear.
    • “More than 40% of Android devices worldwide no longer receive critical security updates, leaving over 1 billion phones exposed to malware and spyware attacks, according to the company.
    • “The problem isn’t a sudden flaw but a slow drift. Android adoption data shows most users are still running software versions that Google no longer fully supports. While recent confusion around Google Play system update dates has raised concerns, Google says that the issue is cosmetic.
    • “The real issue is simpler and more serious: phones running Android 12 or older are now outside the security safety net.”

From the ransomware front,

  • The HIPAA Journal reports,
    • “A new record was set for ransomware attacks last year, with disclosed ransomware attacks increasing by 49% year-over-year to a record-high of 1,174 attacks, according to Black Fog’s 2025 State of Ransomware Report. There was also a 37% year-over-year increase in undisclosed attacks, with 7,079 victims added to dark web data leak sites in 2025. The figures indicate that globally, 86% of ransomware attacks are not disclosed by victims.
    • “Data theft almost always occurs with ransomware attacks. In 2025, 96% of attacks involved data exfiltration prior to file encryption, which results in greater organizational harm. Data exfiltration has contributed to the significant increase in breach costs, as data theft results in greater reputational harm and increased regulatory exposure. In 2025, the average cost of a data breach was $4.44 million globally, and $7.42 million for healthcare data breaches. Healthcare retained its position as the sector most targeted by ransomware groups in 2025, accounting for 22% of disclosed attacks. All sectors experienced an increase in attacks in 2025, apart from education, which saw a 13% year-over-year decrease in attacks.
    • “The breakup of large ransomware groups has led to a fragmentation of the ransomware ecosystem, and the number of active ransomware groups continued to increase in 2025. Black Fog tracked 130 different ransomware groups in 2025, of which 52 were new groups that emerged in 2025, a 9% increase from 2024. Several groups that emerged in 2025 have disproportionately targeted the healthcare sector, including Sinobi, Insomnia, and Devman. Devman issued the largest ever ransom demand of $91 million in 2025 for its attack on China’s real estate development company Shimao Group Holdings. World Leaks, widely believed to be a rebrand of Hunters International, has also claimed several healthcare victims, as have all of the top three most prolific and dangerous ransomware groups of the year: Qilin, Akira & Play.”
  • Cybersecurity Dive adds,
    • “Ransomware attacks on the IT sector were higher in each quarter of 2025 than in the same quarters of 2024, with the sector ranking third behind manufacturing and commercial facilities on hackers’ target lists, according to a new report from the Information Technology Information Sharing and Analysis Center.
    • “Nearly half of all ransomware attacks that the IT-ISAC tracked occurred in the U.S., far surpassing the totals in other countries.
    • “The food and agriculture sector also saw a significantly higher number of ransomware attacks in 2025 than it did in 2024, according to a new report from that sector’s ISAC, which shares leadership with the IT-ISAC.”
  • The Federal Trade Commission has issued its own 2025 ransomware report according to Executivegov.
    • “The Federal Trade Commission has reported that ransomware and other malware-based attacks represent only 2.23 percent of all fraud complaints submitted to the agency.
    • “In the 2025 Ransomware Report published Friday, the FTC shared that, between July 2023 and June 2025, tech support scams were among the most reported fraud types.
    • “About 1 percent of the 42,972 reports the FTC received that allegedly originate from China are ransomware. The majority of the complaints are related to online shopping fraud.
    • “Complaints tied to Russia, Iran and North Korea are relatively rare, with the three countries accounting for only 0.05 percent of all fraud reports the FTC received from 2023 to 2025.”
  • Morphisec calls attention to
    • “Ransomware isn’t slowing down. It’s scaling, adapting, and finding new ways to slip past defenses that many organizations still trust implicitly.  
    • “The Ransomware Reality Check 2026 infographic paints a clear, data-driven picture of the risk landscape ahead: from skyrocketing demands to sophisticated execution methods that beat traditional detection technologies.”  
  • Per Security Week,
    • “Mere data exfiltration is no longer a lucrative approach for ransomware groups, and threat actors may increasingly rely on encryption to regain leverage, Coveware notes in a new report.
    • “Following a series of highly successful data-exfiltration-only attacks conducted by known groups such as Cl0p, other ransomware groups adopted the trend, stealing victims’ data without encrypting it.
    • “The campaigns targeting MOVEit, Cleo, and Oracle E-Business Suite (EBS) customers are proof that the approach no longer delivers return on investment, Coveware says.
    • Cl0p, it explains, started this trend with a simple strategy: it acquired an exploit for a zero-day vulnerability in a popular enterprise file transfer or data storage product, hacked as many instances as possible for data exfiltration, and extorted each compromised entity into paying a ransom.
    • I”n 2021, the group likely made tens of millions of dollars using this tactic in the Accellion campaign, when over 25% of the impacted organizations likely paid a ransom. Roughly 20% of the entities impacted by the GoAnywhere MFT hack also paid a ransom.
    • “In the subsequent campaigns, however, the victims’ willingness to pay dropped significantly: less than 2.5% of those affected by the MOVEit breach paid, and almost none paid in the Cleo and Oracle EBS incidents, Coveware says in its latest ransomware trends report.”
  • Per Cyberscoop,
    • “Ransomware groups crop up like weeds, angling for striking positions in a crowded field rife with turnover, infighting and unbridled competition. Yet, they rarely emerge, as 0APT did late last month, claiming roughly 200 victims out of the gate.
    • “Researchers have thus far seen no evidence confirming 0APT attacked any of its alleged victims, which includes high-profile organizations. Alleged victim data samples and the structure and size of placeholder file trees published by 0APT place further doubt on the group’s supposed criminal escapades. 
    • “Most signs suggest the group is running a massive hoax, but at least some of the threat 0APT poses is grounded in truth. The group’s inflated pretense may be a ruse to create a sense of momentum, gain recognition and attract affiliates.
    • “While 0APT is probably bluffing about the victims it has already compromised, it is not bluffing on the technical capabilities of its actual ransomware,” Cynthia Kaiser, senior vice president at Halcyon’s ransomware research center, told CyberScoop.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • The European Union approved Google’s $32 billion acquisition of cybersecurity startup Wiz, a win for the Alphabet unit’s GOOGL  * * *
    • “Google announced the all-cash deal in March 2025, betting that bringing Wiz under its cloud business would help it fast-track improvements in cloud security and enhance its ability to use multiple clouds, both trends that have gathered pace in the artificial-intelligence era.
    • “Wiz provides cybersecurity software for cloud computing and has presences in New York; Arlington, Virginia; London and Tel Aviv.
    • “The deal—cleared by U.S. antitrust authorities in November last year—was flagged to the EU’s merger watchdog for screening in January.”
  • Cyberscoop relates,
    • “Proofpoint announced Thursday [February 12] it has acquired Acuvity, an AI security startup, as the cybersecurity company moves to address security risks stemming from widespread corporate adoption of agentic AI.
    • “The acquisition strengthens Proofpoint‘s capabilities in monitoring and securing AI-powered systems that are increasingly handling sensitive business functions across enterprises. 
    • “Financial terms of the deal were not disclosed, but Ryan Kalember, Proofpoint’s chief strategy officer, told CyberScoop that the acquisition was beyond a pure “technology acquisition,” with Acuvity’s engineering team slated to join the California-based company. 
    • “Acuvity specializes in visibility and governance for AI applications, including the ability to track how employees and automated systems interact with external AI services and protect custom AI models developed within organizations. The startup’s platform monitors AI usage across multiple deployments, from web browsers to specialized infrastructure including Model Context Protocol (MCP) servers and locally installed AI tools.”
  • Per a February 13 CISA news release,
    • “For years, CISA has responded to an unending wave of cyber incidents targeting edge devices embedded in the Nation’s federal networks and critical infrastructure. The common culprit? 
      • Unsupported hardware and software residing on the edge of organizational networks that vendors are no longer maintaining.
    • Nation-state adversaries have seized these weak points, exploiting them to gain unauthorized access, maintain persistence, and compromise sensitive data. These neglected devices are more than just vulnerabilities; they threaten the Nation’s security, privacy, and resilience. 
    • As the operational lead for federal cybersecurity, CISA recently took a large step toward addressing this systemic risk by issuing Binding Operational Directive (BOD) 26-02, a mandate for federal civilian agencies to identify and replace end-of-support (EOS) edge devices, stay current with software updates, and patch known vulnerabilities. While directed to federal agencies, we strongly encourage all organizations to adopt similar actions. 
    • However, we as a community can and must do more. Managing the lifecycles of hardware and software products can quickly become a daunting, resource-intensive task—especially without an efficient way to determine the EOS status for hardware and software. 
    • Enter OpenEoX: a machine-readable, international standard that transforms how product lifecycle information is exchanged across software, hardware, services, and AI models. By introducing much-needed standardization and automation, OpenEoX brings transparency, efficiency, and unity to asset management. By integrating OpenEoX across the community, both hardware and software producers and consumers can together turn the tide on one of the most serious cyber threats facing the Nation: EOS hardware and software.” * * *
    • Additional Resources
  • Meritalk relates,
    • The FBI Cyber Division’s latest initiative, Operation Winter SHIELD, is growing as more field offices join the cybersecurity defense campaign that aims to turn lessons from investigations into high-impact actions that organizations can take to strengthen their defenses. 
    • The bureau launched Operation Winter SHIELD on Jan. 28 as a two-month effort that spotlights one of 10 “high-impact actions” each week. The initiative is designed to help organizations reduce common breach pathways and harden critical infrastructure systems against nation-state and criminal cyber threats. 
    • Since its announcement, numerous FBI field offices across the nation have voiced their support for the operation – some of the latest field offices to join this week include Seattle, Philadelphia, and Anchorage. 
    • In a video announcement, FBI Cyber Division Assistant Director Brett Leatherman said the campaign distills insights from real-world investigations into practical steps that organizations can take immediately. 
    • “Every winter storms test our infrastructure. Power grids, water systems, and supply chains are pushed to their limits, but the most critical threats to infrastructure don’t come from the weather. They come through our networks,” Leatherman said. 
      • The 10 actions outlined by the FBI include: 
      • Adopt phish-resistant authentication 
      • Implement a risk-based vulnerability management program 
      • Track and retire end-of-life technology on a defined schedule 
      • Manage third-party risk 
      • Protect security logs and preserve them for an appropriate time period 
      • Maintain offline immutable backups and test restoration 
      • Identify, inventory, and protect internet-facing systems and services 
      • Strengthen email authentication and malicious content protections 
      • Reduce administrator privileges 
      • Exercise your incident response plan with all stakeholders 
  • Per Dark Reading,
    • “Microsoft Under Pressure to Bolster Defenses for BYOVD Attacks
    • “Threat actors are exploiting security gaps to weaponize Windows drivers and terminate security processes in targeted networks, and there may be no easy fixes in sight.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Roll Call tells us,
    • “As Congress spent months arguing over COVID-19-era enhanced premium tax credits that many people on the Affordable Care Act used to subsidize their health insurance, a relatively narrow debate over a single policy grew into a much broader and more complicated discussion about how to lower health care costs. 
    • “Concerns about those costs are a top issue for voters ahead of this year’s midterms. But whether Congress can meaningfully address the issue and how candidates communicate that idea to voters depends on the type of cost increases and what is driving them. 
    • “A main reason is that health-related costs mean different things to different people, such as higher insurance premiums, more expensive drugs, co-pay increases, surprise charges or unexpected gaps in coverage.
    • “Health care is probably the most complicated sector of the economy,” said Jonathan Burks, executive vice president of health and economic policy at the Bipartisan Policy Center. “I think when policymakers are talking about affordability, the reason that they can say ‘affordability’ and yet be nowhere near agreement on what they specifically want to do is because of that complexity.”
  • Federal News Network reports,
    • “The Trump administration is telling most agencies to proceed with terminating their collective bargaining agreements and derecognizing their federal unions in response to a pair of 2025 executive orders, despite ongoing litigation.
    • I”n a memo issued Thursday, Office of Personnel Management Director Scott Kupor advised all agencies covered by President Donald Trump’s orders to move forward with either amending or fully canceling their collective bargaining agreements. The president’s orders last year directed a majority of agencies to cancel their union contracts, citing “national security” concerns.
    • “For various reasons, including litigation, implementation of these executive orders at certain agencies and agency subdivisions has been delayed,” Kupor wrote in the Feb. 12 memo. “[OPM] now advises agencies and agency subdivisions covered by [the orders] that they should proceed to terminate or modify collective bargaining agreements.”
    • “The OPM memo tells agencies to notify their federal unions that the agreements are being terminated. It adds, though, that federal employees and agencies not covered by the two executive orders [here and here] can continue collective bargaining procedures as normal.”
  • NCQA announced the draft measurement year 2027 changes to its HEDIS quality measures. The public comment period ends on March 13, 2026 at 5 pm ET. HEDIS measures form a major part of OPM’s FEHB/PSHB plan performance assessment.
  • The American Hospital Association News relates,
    • “The Department of Health and Human Services Feb. 13 issued a request for information on a new 340B rebate model program. The RFI said HHS’ Health Resources and Services Administration’s Office of Pharmacy Affairs, which currently oversees the 340B Drug Pricing Program, will accept comments through March 19.
    • “The RFI asks 340B stakeholders to provide answers to a long list of questions so that HRSA can evaluate whether it should implement a 340B rebate model pilot program and how such a program might be designed. HRSA expressly encourages commenters to “include supporting facts, research, and evidence.”
    • “In a statement, Aimee Kuhlman, AHA vice president of advocacy and grassroots, said, “The AHA welcomes HRSA’s attempt to gather detailed information about the impact of a rebate model. We look forward to working with the agency to answer the many specific questions it has posed to 340B hospitals and other stakeholders. We hope that after careful consideration of comments from 340B hospitals and other stakeholders, HRSA will recognize that imposing hundreds of millions of dollars in costs on hospitals serving rural and underserved communities is not a sound policy.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight. 
    • “It’s the first experimental drug to go through FDA Commissioner Marty Makary’s new program to fast-track drug reviews. The agency previously approved a generic antibiotic through the new drug review program in December.
    • “The FDA, in its letter rejecting bitopertin, cited “uncertainties” about the correlation between the blood-based biomarker used as the efficacy goal in Disc’s clinical trials and clinical benefit for patients.” 
  • Fierce Pharma informs us,
    • “With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. 
    • “Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. 
    • “FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency’s threshold of substantial evidence of effectiveness to support approval of Translarna,” Matthew Klein, M.D., PTC’s chief executive, explained in a statement. 
    • “PTC is “disappointed that FDA approval cannot be achieved,” Klein said, citing the decades of development work that have gone into the company’s protein restoration therapy. 
    • “In a letter to the U.S. DMD community, PTC cited unresolvable “differences in data interpretation” with the FDA, Pharmaphorum reports.” 
  • and
    • “It’s déjà vu all over again. Just as the kidney disease space becomes increasingly competitive, Novartis has found itself intending to turn a statistical miss into a regulatory win.
    • “Despite the phase 3 Align trial narrowly failing to hit its kidney function endpoint, Novartis announced Friday that it will pursue traditional FDA approval for Vanrafia (atrasentan) in IgA nephropathy (IgAN).” * * *
    • “For its part, Novartis is leaning on a “positive difference” with Vanrafia versus placebo in eGFR change from baseline at Week 136, as well as a “clinically meaningful” improvement for the drug at Week 132, when study treatment ended.” 

From the judicial front,

  • The AHA News reports,
    • “The U.S. District Court for the Eastern District of Texas Feb. 12 vacated a final rule by the Federal Trade Commission that changed premerger notification rules, form and instructions under the Hart-Scott-Rodino Antitrust Improvements Act. The rule had increased reporting requirements on the HSR form. The final rule was challenged by the U.S. Chamber of Commerce in 2024.
    • “First, the Final Rule exceeds the FTC’s statutory authority because the agency has not shown that the Rule’s claimed benefits will ‘reasonably outweigh’ its significant and widespread costs,” Judge Jeremy D. Kernodle wrote in his opinion. “Though the FTC asserts that the Rule will detect illegal mergers and save agency resources, the FTC fails to substantiate these assertions. The Final Rule is therefore not ‘necessary and appropriate,’ and the statute ‘does not authorize [the FTC] to promulgate [the Final Rule].’”
    • “The AHA filed an amicus brief in the case last year, explaining that the changes made by the FTC under the HSR Act were “unnecessary and unlawful.” Key aspects of yesterday’s decision, including the court’s rejection of the FTC’s reliance on a study regarding hospital mergers, were based on arguments made in the AHA’s amicus brief.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old. COVID-19 activity is elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.”
  • The University of Minnesota’s CIDRAP adds,
    • “Six more US children died of influenza last week, for a total of 66 pediatric deaths this respiratory illness season, as flu rates remained moderate to very high in different regions of the country, per the weekly FluView update from the Centers for Disease Control and Prevention (CDC).
    • “Of all pediatric deaths this season, 90% who were eligible for vaccination were unvaccinated. This age-group has been particularly vulnerable, with high-severity illness, while both adults and older adults are currently categorized as having moderate-severity illness. 
    • “The 2024-25 influenza season saw 289 pediatric deaths—the most reported in a non-pandemic flu season since the CDC began tracking child flu deaths in 2004.
    • “COVID-19 rates are still elevated and are growing in some states, but ED visits for the virus are decreasing.”
  • The AHA News tells us,
    • “The South Carolina measles outbreak has grown to 950 cases, the state’s Department of Public Health reported Feb. 13. Of those, 246 cases are under age 5, 611 cases are from age 6-17, 82 cases are age 18 or older, and the ages of 11 cases are unknown. Since Jan. 1, 910 confirmed measles cases nationwide have been reported to the Centers for Disease Control and Prevention. The vaccination status of 94% of cases is classified as unvaccinated or unknown.”
  • The UMN CIDRAP again adds,
  • Radiology Business informs us,
    • “A novel artificial intelligence model could improve the identification of a potentially deadly pregnancy complication that often goes undetected. 
    • “Placenta accreta spectrum happens when the placenta improperly attaches, typically too deeply, to the uterine wall. Due to its potential to trigger life-threatening hemorrhage during or after delivery, it is considered a high-risk complication of pregnancy and is a leading cause of maternal mortality and morbidity. 
    • “Despite the dangers associated with the condition, its presence often (up to half the time) evades detection during pregnancy. With instances of PAS on the rise, there is a critical need for methods of identifying the condition prior to delivery. 
    • “This week, during the Society for Maternal-Fetal Medicine (SMFM) 2026 Pregnancy Meeting, researchers shared new data on a novel AI tool they believe could help improve the diagnosis of PAS. 
    • “Our team is very excited about the potential clinical implications of this model for accurate and timely diagnosis of PAS,” researcher Alexandra L. Hammerquist, MD, a maternal-fetal medicine fellow at Baylor College of Medicine in Houston, said during the presentation. “We are hopeful that its use as a screening tool will help decrease PAS-related maternal morbidity and mortality.”   
  • Fierce Healthcare informs us,
    • “While Generation Z and millennial workers still account for fewer claims than their baby boomer counterparts, claims in these populations are rising fast, according to a new report.
    • “UnitedHealthcare and the Health Action Council (HAC) earlier this month released their annual white paper digging into key trends impacting the employer market and found that the number of claims for lower-aged workers are increasing more quickly than they did for baby boomers.
    • “Between 2023 and 2025, the year-over-year growth rate in claims was nearly double that of baby boomers. The study also found that younger individuals were developing conditions like diabetes or obesity earlier in life and were less likely to be engaged with a primary care provider (PCP), instead frequenting the emergency room.
    • “All of these factors can drive up medical costs for employers in the long term, according to the report.” * * *
    • “For employers or plan sponsors that identify this trend, the challenge is how to best engage this population around their health. One approach, Kurtzweil said, is to try and incentivize them to develop a primary care relationship through education and communication programs that make clear the value of a PCP.
    • “Or, plan sponsors can consider alternative options like on-site clinics or virtual care that can connect people to the healthcare system without necessarily leaning on primary care, he said.”
  • The Health Care Cost Institute lets us know,
    • “Nearly half of adults in the US have high blood pressure or high cholesterol, which are key risk factors of heart disease – the leading cause of death in the US.  HHS estimates about 30 million adults in the US have blood pressure at levels where medication use is recommended but are untreated. The American Heart Association estimates the direct and indirect costs of cardiovascular disease in the US is more than $414B. Commonly used, low-cost medications can effectively treat high blood pressure and high cholesterol and prevent more serious and costly heart-related conditions like heart attack or stroke.” 
  • Medscape adds,
    • “Patients worried about potential side effects of statins can rest easy, according to a new large-scale study: The vast majority of adverse effects listed on statin medications simply never occur.
    • “The study, published in The Lancet, analyzed individual patient data from 154,000 patients in 23 large, randomized controlled trials conducted by the Cholesterol Treatment Trialists’ Collaboration.”
  • Healio points out,
    • “Night shift workers and individuals who regularly achieve fewer than 6 hours of sleep demonstrate an increased risk for osteoarthritis, according to findings published in Arthritis Care & Research. 
    • “We chose to study the associations of shift work and sleep with osteoarthritis because accumulating laboratory evidence had indicated that maintenance of daily circadian rhythms are critical for homeostasis of articular cartilage and other joint tissues,” Elizabeth Yanik, PhD, ScM, assistant professor in the department of orthopedic surgery at Washington University, St. Louis, told Healio. “However, few studies had investigated the relationships between circadian clock disruption, sleep and osteoarthritis risk in humans.”
  • The Wall Street Journal adds,
    • “Attention lapses from sleep deprivation result from the brain’s efforts to clean itself, a process usually occurring during sleep, research suggests.
    • “A study in Nature Neuroscience found sleep-deprived brains experience fluid pulses during wakefulness, causing brief attention reductions.
    • “During these attention lapses, cerebrospinal fluid surges through the brain, and study participants experienced slower reactions and missed cues.”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Annual inflation slowed in January, falling more than economists expected, helped by declining prices for gasoline and used vehicles.
    • “Cooler price increases overall are positive news for the economy, easing concerns that the Trump administration’s steep tariffs will lead to broader ongoing inflation. Yet price increases in January for items like computers and washing machines suggest inflation is continuing to weigh on Americans exhausted by price hikes.
    • “Consumer prices rose 2.4% in January from a year earlier, cooler than 2.7% in December and below the 2.5% economists surveyed by The Wall Street Journal had expected. Core prices, which exclude volatile food and energy items, rose 2.5% from a year earlier, in line with expectations.” * * *
    • “Analysts and economists have focused on the rising price of goods as a way to measure tariff impact, but the report also showed higher costs for an array of services, including airline tickets and hospital care. Overall, costs for services rose at their fastest monthly clip in a year, a frustrating data point for economists who have warned that lingering services inflation will be hard to slow.” 
  • Modern Healthcare relates,
    • “Health systems are investing billions of dollars into inpatient facilities, driven by an aging population and increasing demand for specialized care. 
    • “In recent years, providers have largely focused their investing on extensive outpatient projects. They also face ongoing cost pressures and regulatory uncertainty.
    • “Still, several are looking to add to their inpatient footprint. 
    • “Mark Pascaris, senior director at credit ratings agency Fitch Ratings, said demand for inpatient projects is particularly strong in competitive markets with growing populations.
    • “I think we have and will continue to see plenty of big-ticket hospital constructions,” Pascaris said. “We can’t ignore the inpatient footprint. The [COVID-19] pandemic taught all of us that we still need ICUs. We still need inpatient surgery suites.” 
  • Per Beckers Payer Issues,
    • “Humana is in talks with Sarasota, Fla.-based MaxHealth — a primary care network and platform focused on adults and seniors — regarding an acquisition, Bloomberg reported Feb. 12.
    • “According to Bloomberg sources, MaxHealth, owned by private equity firm Arsenal Capital Partners’ Best Value Healthcare, could have been valued at about $1 billion.
    • “Humana President and CEO Jim Rechtin previously said the company is looking to expand its primary care footprint.
    • “We also hope to soon announce a strategic acquisition in the primary care space,” Mr. Rechtin saidon a Feb. 11 earnings call.” 
  • The Employee Benefits Research Institute prepared a report titled “Cell and Gene Therapies in Employment-Based Health Insurance: Financing the High-Cost, High-Impact Future.” Check it out.
  • MedCity News considers “From Claims Payer to Care Partner: What AI Really Changes in Health Insurance, and What It Doesn’t.”
    • “AI can help health plans reduce friction, speed revenue-cycle throughput, and improve member experience, but only when it is deployed with strong data discipline, modern integration patterns, and a governance model that treats AI as “augmented intelligence,” meaning powerful, assistive, and accountable.”
  • The Wall Street Journal notes,
    • “In one experiment, offering human contact to loan applicants during the approval process made them much more likely to eventually accept a loan if offered.
    • “A study found that providing access to a human, even if unused, boosts customer satisfaction and confidence in sensitive online transactions.
    • “Only about 10% of customers offered human assistance actually use it, suggesting the cost of providing the option is lower than perceived.”
  • Fierce Pharma points out,
    • “Determined to avoid a repeat of the supply shortfalls that plagued early GLP-1 rollouts for obesity, Eli Lilly has amassed a sizable store of its oral weight loss candidate orforglipron. 
    • “Specifically, Lilly had secured “pre-launch inventories” worth $1.5 billion as of Dec. 31, with most of that supply tied to orforglipron, the company said in a securities filing this week. 
    • “The update on Lilly’s pending launch inventory comes after the Indianapolis drugmaker said last February that it had built up nearly $550 million in early inventory that was again primarily related to orforglipron.” 
  • BioPharma Dive informs us,
    • “Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration.
    • “The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for all of 2025, figures that came at the higher end of a projected forecast from November. U.S. sales more than halved between the third and fourth quarters, but still made up more than 60% of Moderna’s full-year revenue, in part because of the successful launch of the COVID shot mNEXSPIKE and a strong U.S. retail COVID vaccine market.”
  • Per MedTech Dive,
    • “Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don’t take insulin. 
    • “New CEO Jake Leach told investors on Thursday that the company has been “sitting here waiting for a coverage decision” from the Centers for Medicare and Medicaid Services. Dexcom expects CMS to propose a coverage expansion in the first half of 2026, BTIG analyst Marie Thibault wrote in a note to clients Thursday. 
    • “Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. 
    • “In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–

Happy Lincoln’s Birthday

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Department of Homeland Security is on the verge of a shutdown after Senate Democrats voted to block a bill to fund the agency, saying negotiations with Republicans to put new restrictions on immigration enforcement hadn’t made enough progress.
    • “A bill to fund DHS through September failed to advance with 52 in favor and 47 opposed, short of the 60 votes required. Republicans control the Senate 53-47 but need Democratic support to pass most bills due to the longstanding filibuster rule.
    • “Democratic Sen. John Fetterman of Pennsylvania voted with Republicans to advance the bill, while Senate Majority Leader John Thune (R., S.D.) switched his vote from yes to no to preserve his ability to bring the bill up again. Sen. Mitch McConnell (R., Ky.) was absent.
    • “DHS oversees Immigration and Customs Enforcement and Customs and Border Protection as well as the Federal Emergency Management Agency, the Transportation Security Administration and the U.S. Coast Guard. While the failed vote sets the stage for funding to lapse at DHS for at least a week, there isn’t expected to be any significant impact on border enforcement from the shutdown.”
  • The Washington Post adds,
    • “The Senate is not expected to hold any more votes before a shutdown starts at 12:01 a.m. Eastern time on Saturday, and many senators were set to leave town Thursday to travel to the Munich Security Conference. Schumer and Thune have said they are prepared to bring senators back early if a deal comes together.” * * *
    • “This shutdown would affect only DHS — but it would not shutter U.S. Immigration and Customs Enforcement or Customs and Border Protection, because Republicans sent those agencies tens of billions of dollars in additional funding last year that would allow them to continue to operate.
    • “Instead, the brunt of a shutdown would fall on the Transportation Security Administration, the Federal Emergency Management Agency, the Coast Guard and other agencies within DHS. It would affect about 13 percent of the federal civilian workforce, most of whom would be forced to work without pay, according to data from DHS and the Office of Personnel Management.”
  • The Wall Street Journal tells us
    • “The White House and Health Secretary Robert F. Kennedy Jr. have shaken up the top ranks at his department, a move meant to install more disciplined messengers and smoother operations ahead of the midterm elections.
    • “Kennedy and White House officials tapped Chris Klomp, the head of Medicare and a former healthcare executive, to lead the department as its No. 2 under Kennedy, administration officials said. Klomp will have responsibility for operations and messaging, and he will be aided by at least three other agency lieutenants to take senior counselor roles under him, the officials said.
    • “We’re structuring in such a way that we can move faster and we can make sure the quality is uniform,” Klomp said in an interview.” * * *
    • “The three other senior advisers tapped to help Klomp include John Brooks, who currently heads policy at the Centers for Medicare and Medicaid Services; Grace Graham, who leads the Food and Drug Administration’s policy office; and Kyle Diamantas, who heads FDA’s food division. Brooks will oversee CMS matters, while Graham and Diamantas will have roles managing the FDA.”
  • Beckers Payer Issues informs us,
    • “Fourteen health insurers have voluntarily committed to CMS’ “Advancing Chronic Care with Effective, Scalable Solutions” model, according to a Feb. 12 CMS news release shared with Becker’s.
    • “The insurers that are on board will work toward achieving alignment with the model by 2028. The plans represent 165 million Americans.
    • “With a decade-long evaluation period beginning in July, ACCESS will explore whether linking payments to clinical outcomes can facilitate technology in chronic disease management, focusing on Medicare beneficiaries. Targeted conditions include high blood pressure, diabetes, chronic musculoskeletal pain and depression. The agency began accepting applications, which are due in April, on Jan. 12.
    • “The FDA’s “Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot” will operate in conjunction with ACCESS, allowing expanded availability of relevant devices.”
  • The Internal Revenue Service issued a draft of Publication 969 Health Savings Accounts and Other Tax-Favored Health Plans For use in preparing 2025 Returns.
  • The American Hospital Association News lets us know,
    • “A bipartisan letter supported by the AHA was sent by members of Congress Feb. 11 to the Department of Homeland Security, urging the agency to grant health care workers an exemption from the $100,000 filing fee for H-1B visas. The letter, led by Reps. Yvette D. Clarke, D-N.Y., and Michael Lawler, R-N.Y., was signed by 100 lawmakers. “Imposing a $100,000 fee for new H-1B visa petitions will exacerbate hospitals’ existing staffing challenges and could push chronically underfunded hospitals to their financial brink,” the legislators wrote. “If these hospitals cannot petition for new H-1B visas to address their staffing needs without also having to pay this fee, it will further damage their financial viability. Critically needed open positions will simply go unfilled, leaving rural and high-poverty urban areas without adequate access to care.”
  • and
    • “The Administration for Strategic Preparedness and Response has launched a $100 million competition to support the development of antiviral drug therapies targeting viruses in the Togaviridae and Flaviviridae families, such as dengue, Zika, West Nile and Chikungunya. The initiative, called the Small Molecule Approaches for Rapid and Robust Treatment Prize, will be coordinated by ASPR’s Biomedical Advanced Research and Development Authority. BARDA plans to include input from experts in drug development, virology, artificial intelligence, medicinal chemistry and public health for the program. A series of virtual information sessions will be held in the coming weeks on the initiative, which has a May 11 application deadline.” 
  • Federal News Radio interviews Tammy Flanagan about federal employee retirement benefits.
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC), together with the Office of Personnel Management (OPM), today provided federal agencies with a joint technical assistance document addressing telework as a reasonable accommodation for federal employees with disabilities.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.
    • “Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.
    • “The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makaryand Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.”
  • Per FDA news releases,
    • “The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.”
  • and
    • “The U.S. Food and Drug Administration has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy (HRT), to clarify risk considerations for these drugs. Specifically, risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning,” the agency’s most prominent safety-related warning.”

From the judicial front,

  • Fierce Pharma reports,
    • “In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.
    • “While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering.”
    • “When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. 
    • “AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “Interest in lipoprotein(a), or Lp(a), is on the rise thanks to mounting evidence that the genetically inherited lipid particle may be a key missing link in unexplained heart attacks and strokes. While current treatments are limited, experts say that will likely change in the near future when new drugs begin to enter the market.
    • :Nathaniel Lebowitz, MD, who leads preventive cardiology at Hackensack University Medical Center and serves as an assistant professor of internal medicine at Hackensack Meridian School of Medicine, has spent two decades studying this biomarker. He is now part of the American Heart Association (AHA) Lp(a) Discovery Project, a national initiative aimed at expanding physician and patient awareness as new therapies move closer to market. Lebowitz spoke with Cardiovascular Business at length about this important topic.
    • “Lp(a) is a major, major killer. And most of the population, and even most doctors, don’t know the exact degree of how dangerous it really is,” he explained.
    • “Lebowitz noted that Lp(a) is often responsible when patients suffer cardiovascular events despite not showing any of the normal warning signs.
    • “When somebody who you wouldn’t expect to have a stroke or a heart attack has one and does not have traditional risk factors to speak of, check Lp(a), because it will be positive,” he said.
    • “Lp(a) is genetic and present in about 20% of the general population. Guidelines from the AHA, American College of Cardiology and National Lipid Association now emphasize screening in individuals with a family history of premature heart disease, as well as cascade screening of first-degree relatives when Lp(a) is identified. Levels typically do not fluctuate significantly, so testing once is believed to be generally sufficient.
    • “I consider it a risk elevator. It’s a risk multiplier,” Lebowitz said. “So if somebody is considered low risk for cardiovascular disease, but they have Lp(a) now, I would consider them intermediate risk. If they’re intermediate risk, but they have Lp(a), I would now consider them high risk and treatment should ensue accordingly.”
    • “Currently, there are no approved therapies specifically targeting Lp(a), but that may soon change. Several investigational agents are in late-stage clinical trials, including small interfering RNA (siRNA) therapies designed to silence the gene responsible for producing Lp(a).”
  • The New York Times provides a look at what alchohol does to your body.
    • “Dry January has come and gone, but Americans’ relationship with drinking is undergoing a more lasting change. According to one recent poll, just 54 percent of U.S. adults said they consume alcohol, the smallest percentage in nearly 90 years of data collection. That may be because more people are taking alcohol’s negative health consequences seriously.
    • “Drinking alcohol can have profound effects on the brain and body. In the moment, some of those effects can be pleasurable. But in the long term, especially when it’s consumed in large quantities, alcohol can cause serious health harms.”
  • and tells us,
    • “Fertility experts know that the more eggs retrieved from a woman, the better the chances that one of them will lead to a viable embryo that will result in the birth of a baby.
    • “Now, a new study suggests something startling, even to many in the field: the conventional method of searching for eggs often fails to find all of them, and a new technology that automates the process may significantly increase the number recovered.
    • Using the conventional method, embryologists use high-powered microscopes to search the follicular fluid extracted from women in fertility clinics. The fluid is then discarded. The study, published in Nature Medicine on Thursday, reported that a device that uses microfluidic technology to sift through follicular fluid found additional eggs for more than half of the patients.
    • “It’s very, very surprising,” said Dr. Mitchell Rosen, who directs the reproductive laboratories at the University of California, San Francisco and was not involved in the study. “They were finding eggs that we wouldn’t otherwise have had the potential to use.”
  • MedPage Today informs us,
    • “Receiving an mRNA SARS-CoV-2 vaccine during or shortly before pregnancy had no impact on kids’ neurodevelopmental outcomes, a multicenter prospective observational study found.
    • “Kids between ages 18 and 30 months scored similarly on the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) (adjusted median difference -3.4, 95% CI -9.7 to 3.0) as well as in each of the five specific ASQ-3 domains, reported George Saade, MD, of Eastern Virginia Medical School in Norfolk, Virginia, during a presentation at the Society for Maternal-Fetal Medicine (SMFM) annual meeting.
    • “Scores on other neurodevelopment assessments that evaluated emotional and behavioral problems, risk for autism spectrum disorder, and temperament were also similar between groups.
    • “We conclude that the primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy, and there was no association with secondary neurodevelopmental outcomes,” Saade said during his presentation.
    • “Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination and pregnancy,” he added.
    • “Indeed, much research has found no link between COVID vaccination in pregnancy and adverse outcomes for children, including at least two studies showing no increase in birth defects.”
  • BioPharma Dive observes,
    • “An experimental medicine from BridgeBio Pharma, the San Francisco-area biotechnology company, has succeeded in a late-stage clinical trialas a treatment for the most common type of dwarfism, results which could tee up an approval and greater competition for two other closely watched therapies.
    • “The trial enrolled around 110 children with achondroplasia, who, over a main treatment period of a year, were given either a placebo or BridgeBio’s drug, called infigratinib. On Thursday, BridgeBio announced that those in the drug arm were growing taller faster. Depending on the measure, this “annualized height velocity” was, on average, between 1.74 and 2.1 centimeters greater per year than what researchers observed in the control group.
    • “Not only did infigratinib meet the trial’s central goal, it also scored so well on a couple other height and growth tests that BridgeBio said it set records for a randomized study of achondroplasia patients. The drug was well tolerated, too, as no serious adverse events were tied to it. No one dropped out of the trial because of side effects either. BridgeBio did disclose three cases of patients having abnormally high levels of phosphate in their blood, but all were mild, transient, asymptomatic, and didn’t require the dose given to be changed or stopped.”
  • Beckers Hospital Review notes,
    • “The number of active drug shortages has declined sharply since June, according to the FDA’s drug shortage database.
    • “Eighty drugs were in shortage as of Feb. 12, down from 194 in mid-June.
    • “The decline reflects updates to the FDA’s database, which is modified daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also points out “12 recent drug shortages, according to the FDA database.”

From the U.S. healthcare business front,

  • Per an Institute of Clinical and Economic Review news release,
    • “Institute for Clinical and Economic Review Publishes Final Evidence Report on Medication for Smoking Cessation
    • “Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared to varenicline; Manufacturer setting a price for cytisinicline to align with value would help ensure public health goals for smoking cessation are met.”
    • Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations 
  • Beckers Payer Issues reports,
    • “Most of the country’s largest insurers reported year-over-year increases in medical cost ratios in 2025.
    • “Centene reported the highest medical loss ratio at 91.9%, driven by higher marketplace medical costs, Medicaid cost pressures in behavioral health and home health, and program changes in the Medicare prescription drug plan business.”
    • The article provides the largest insurers MLRs for 2023, 2025 and 2025.
  • Healthcare Dive relates,
    • “Hospital operator Tenet Healthcare expects the expiration of more generous Affordable Care Act subsidies to lower its earnings growth this year by about $250 million.
    • “Still, Tenet’s expected loss is smaller than those of some of its peers, including HCA Healthcare, which last month said it expects to lose up to $900 million from the lapse of the enhanced tax credits in 2026.
    • “Excluding the ACA headwind and the impact of some Medicaid state supplemental payments, Tenet anticipates it will grow adjusted earnings before taxes and other non-operating expenses by about 10% this year compared to 2025, executives said on a Wednesday call with investors.”
  • BioPharma Dive tells us,
    • “Sanofi on Thursday announced the ouster of CEO Paul Hudson after a six-year tenure that included a major transformation of the French drugmaker and the rise of Dupixent into one of the world’s best-selling medicines.
    • “Hudson will be replaced by current Merck KGaA CEO Belén Garijo, who is leaving her post at the German company at the end of April as part of a planned transition. Olivier Charmeil, executive vice president for general medicines, will serve as interim CEO after Hudson’s departure at the close of business on Feb. 17, Sanofi said.
    • “Belén Garijo will bring an increased rigor to the implementation of Sanofi’s strategy and accelerate the preparation of the group’s future,” Sanofi said. “Her priority will be to strengthen the productivity, governance and innovation capacity of research & development.”
  • Fierce Healthcare informs us,
    • “Maven Clinic, a virtual women’s and family health provider, is teaming up with health tech company Color Health to support family building after a cancer diagnosis. 
    • “The partnership’s goal is to expand access to oncofertility care, helping patients of childbearing age going through the cancer journey to understand and preserve their fertility options. Members will receive access to oncologists, dietitians, mental health providers, fertility preservation specialists and care advocates. The services will be available to cancer patients through employers and payers to start. 
    • “Both of us have seen the attention being paid by employers to what it really looks like for their team members going through a cancer diagnosis, because it’s happening at such a rapid clip now,” Caroline Savello, president at Color, told Fierce Healthcare. A quarter of Color patients are between the ages of 18 and 45.”
  • and
    • “Specialty care company Lantern revealed it will expand its cancer care navigation platform through a new partnership with AccessHope.
    • “Through the partnership, Lantern’s platform will now include expert review at each point in a patient’s care journey, preventing misdiagnoses and ensuring treatments meet clinical guidelines. Reviews will be conducted by experts at National Cancer Institute (NCI)-designated cancer centers, according to the announcement.
    • “Lantern said the reviews will be available for both adult and pediatric cancers as well as solid tumors and blood-based disease.
    • “Dickon Waterfield, president of Lantern, told Fierce Healthcare that the “beauty of this partnership” lies in the ability to allow people to seek care in their local communities while also providing them supports at the standard of an NCI-designated facility.”

Midweek report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “Republicans and Democrats sparred Wednesday on the potential real-world harms of a partial shutdown for the Department of Homeland Security, as Congress marched toward a funding deadline for the agency amid a dispute over immigration enforcement policies.
    • “The House Homeland Security Appropriations Subcommittee held a hearing with officials from five national security and emergency management agencies to highlight what would happen if a continuing resolution expires Saturday without further action from Congress.”
  • and
    • “Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. 
    • “At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries.
    • “But Guthrie stressed that further changes could be forthcoming.
    • “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.”
    • “Rep. Morgan Griffith, R-Va., chair of the Health Subcommittee, said after the hearing that he hopes to mark up affordability legislation before Memorial Day, but acknowledged the appetite for bipartisan cooperation will be “tough” given the political climate.” 
  • Beckers Payer Issues adds,
    • “Sens. Elizabeth Warren, D-Mass., and Josh Hawley, R-Mo., have introduced legislation that would ban health insurers and pharmacy benefit managers from owning medical providers, and would force companies in violation to divest within one year of the bill’s enactment.
    • :The “Break Up Big Medicine Act” would also prohibit a parent company of a prescription drug or medical device wholesaler from owning a medical provider or management services organization.”
  • The American Hospital Association tells us,
    • “The Senate Special Committee on Aging held a hearing Feb. 11 on issues impacting physician burnout. The AHA provided a statement for the hearing and urged Congress to pass legislation to address burnout, including the Improving Seniors’ Timely Access to Care Act (H.R. 3514/S. 1816), legislation that would streamline prior authorization requirements under Medicare Advantage plans by making them simpler and more uniform, and the Save Healthcare Workers Act (H.R. 3178/S. 1600), a bill that would make it a federal crime to assault a hospital employee. The AHA also urged Congress to pass the Resident Physician Shortage Reduction Act of 2025 (H.R. 3890/S. 2439), which would add 14,000 Medicare-funded residency positions over seven years.”
  • Per OPM news releases,
    • [On February 10, 2026], the US Office of Personnel Management (OPM) convened senior administration officials, federal agency leaders, and industry executives at the White House for a US Tech Force (Tech Force) roundtable focused on strengthening the federal government’s technology workforce and accelerating innovation across agencies.
  • and
    • “US Office of Personnel Management (OPM) Director Scott Kupor appeared on Fox Business to discuss the administration’s launch of the U.S. Tech Force, a new initiative aimed at strengthening the federal workforce with top technical talent and modernizing critical government systems.” You can watch the Director’s appearance here.
  • Govexec discusses the tax implications of making Roth IRA conversions in the Thrift Savings Plan.
    • “Beginning Jan. 28, the Thrift Savings Plan now allows participants to convert traditional (pre-tax) balances into Roth (after-tax) balances inside the TSP itself. This long-awaited change gives federal employees and retirees more flexibility over how and when they pay taxes on retirement savings.
    • “While the mechanics of the change are straightforward, the implications are not. A Roth in-plan conversion is a tax event and not just a retirement planning decision. Once it is made, it cannot be reversed. Knowing this beforehand helps you choose effective planning tools and avoid costly errors.”
  • Per an HHS news release,
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “Today, HHS, through the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), announced progress made in executing on President Trump’s, Secretary Kennedy’s, and Deputy Secretary O’Neill’s directive to lower the cost of healthcare for all Americans by leveraging and coordinating the nation’s strategic advantages in technology, artificial intelligence (AI), and healthcare infrastructure.” * * *
    • “ASTP/ONC released the draft USCDI v7 on January 29, 2026, proposing 29 new data elements and one significantly revised element to strengthen nationwide interoperability. Draft USCDI v7 expands standardized health data to support more efficient adverse event reporting, nutrition information exchange, and quality improvement, ultimately modernizing how health information is used across the entire health care system to Make America Healthy Again.”
    • “In the coming days, ASTP/ONC will launch the EHIgnite Challenge, a two-phase prize competition to improve the usability, readability, and actionability of single-patient electronic health information (EHI) exports. The EHIgnite Challenge will catalyze the development of tools and workflows, focused on the application of AI, that transform raw EHI into clear, usable information to better support care transitions, provider onboarding, and patient understanding and engagement. Awards will support both concept development and prototype solutions through 2027.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “For all its success across a wide range of cancer types, Merck’s PD-1 superstar Keytruda has never been able to crack the code for one of the toughest-to-treat indications in oncology—ovarian cancer.
    • “But now, 13 years after the FDA initially blessed it for skin cancer, the U.S. regulator has approved Keytruda as a second- or third-line treatment for patients with a certain type of ovarian cancer.
    • “With the green light, Keytruda becomes the first immune checkpoint inhibitor approved for this indication. 
    • “Keytruda is to be used in combination with the chemotherapy paclitaxel and with or without Roche’s targeted cancer therapy Avastin. The endorsement covers those with platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma with PD-L1-positive tumors. 
    • “The nod also covers infused Keytruda and its subcutaneous version, Keytruda Qlex, which the FDA blessed five months ago.” 

From the public health and medical / Rx resarch front,

  • STAT News reports,
    • “Food fights pitting low-carbohydrate diets against low-fat diets are off the mark when they aim at heart health, a large new study suggests. To reduce heart disease risk, it’s the quality, not the quantity, of those carbs or fats that matter. Diets high in plant-based foods, whole grains, and unsaturated fats led to better heart health, the researchers found. Low-fat dairy also got a nod when part of a diet featuring whole grains, vegetables, and fruits.
    • “Not all carbs are created alike; nor are all fats. Whole grains, fruits, vegetables, nuts, legumes, and olive oil are associated with lower risk of coronary heart disease (CHD), whether they contain carbohydrates or fats. But diets high in refined carbohydrates and animal proteins and fats were associated with a higher risk of heart disease, according to the new study, published Wednesday in the Journal of the American College of Cardiology.” 
  • MedPage Today relates,
    • “The CDC excludes homicide, suicide, and overdose in defining “maternal mortality,” instead focusing on more medical causes.
    • “An analysis of 2018-2023 data showed that drug overdoses, homicides, and suicides accounted for more than a quarter of all deaths among pregnant and postpartum women.
    • “Violence and overdose accounted for 2,018 deaths, while cardiovascular causes, hypertension, infection, and hemorrhage together accounted for 2,141 deaths [over the period 2018-2023].” * * *
    • “Maeve Wallace, PhD, MPH, of the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson, told MedPage Today that the results were not surprising.
    • “Research dating back decades finds that rates of violent death exceed obstetrical causes of death for pregnant women,” Wallace said. “What is disheartening is that this continues to be the case.”
    • “This analysis “can help policymakers concerned with maternal health understand pregnancy as a dangerous condition,” and can encourage policy-level solutions to promote women and girls’ health and safety, she added.”
  • and
    • “A meta-meta-analysis of randomized trials showed exercise reduced depression and anxiety symptoms.
    • “Group aerobic exercise appeared to be most effective for depression, while exercise of shorter duration and lower intensity was most associated with reductions in anxiety symptoms.
    • “The researchers concluded that tailored exercise programs are an “accessible and cost-effective” treatment option for depression and anxiety.”
  • Healio informs us,
    • “Statin use had a statistically significant protective effect against acute asthma exacerbations in mild asthma among Black adults and adults with obesity, according to data published in Annals of Allergy, Asthma & Immunology. 
    • “The pleiotropic effects of statins may extend beyond cholesterol control due to their anti-inflammatory and immunomodulatory properties, prompting interest in their potential use for chronic airway diseases, William Crawford, MD, physician with the department of allergy, Kaiser Permanente Southern California, and colleagues wrote.
    • “But mixed results in prior research including beneficial and null effects in asthma outcomes indicate that determining the patient subgroups that may benefit most from treatment is vital in determining the role that statins may have in asthma management.” 
  • The American Journal of Managed Care observes,
    • “More than half of patients with long-term conditions (LTCs) surveyed said they preferred a remote consult vs an in-person visit with their referring physician, particularly for discussion of results and medication renewal, according to a new study
       published in JAMA Network Open.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The U.S. economy added 130,000 jobs in January, its strongest growth in over a year, and a sign that the labor market may be shaking off its recent stagnation.
    • “January’s robust gains surprised forecasters, blowing far past consensus expectations, while solidifying expectations the Federal Reserve will keep rates on hold for the foreseeable future. The unemployment rate dipped to 4.3% from 4.4% in December, the Labor Department said Wednesday. And workers’ wages rose.
    • “The gains were highly concentrated in healthcare and social-assistance fields, which includes jobs like home health aides and residential care workers. Such jobs tend to grow regardless of the economy’s health and have long been an engine of U.S. job growth.”
  • Fierce Healthcare relates,
    • “Humana CEO Jim Rechtin acknowledged the noise around the latest Medicare Advantage rate notice and said that while the flat proposal is a concern, the company will continue to push forward on its performance improvements.
    • “He said that part of the challenge for policymakers, regardless of political alignment, is managing the program as it “sits at the intersection of U.S. fiscal pressures and a program that is incredibly popular with seniors.”
    • “Every administration wrestles with how to balance these two forces,” Rechtin said.
    • “We are committed to always protecting our consumers the best we can, and we are very aware that we must do that within the constraints of the annual funding environment,” he continued. “If that funding environment cannot fully support our benefit structure, then we will adapt as we have in the past.” * * *
    • “Humana reported a $796 million loss in the fourth quarter of 2025, with its losses growing year over year as increased utilization continues to drag Medicare Advantage (MA) plans.
    • “By comparison, Humana reported a $693 billion loss in the fourth quarter of 2024. The company did post a profit for the full year of $1.2 billion, flat from the company’s $1.2 billion haul in 2024.”
  • and
    • “Hinge Health’s shares were up 13% in after-hours trading Tuesday after the digital health company reported a strong fourth quarter and a bright outlook for 2026.
    • “The digital musculoskeletal (MSK) care provider, which went public in late May, brought in fourth-quarter revenue of $171 million, up 46% from the same period a year ago and easily topping Wall Street analyst estimate of $155 million for fourth-quarter revenue. The company posted fourth-quarter adjusted earnings of 49 cents per share, significantly exceeding analyst estimates of 14 cents per share. Hinge Health’s non-GAAP income from operations increased 124% to $48 million during quarter.
    • “Free cash flow for the quarter was $61.5 million, representing a free cash flow margin of 36%.
    • “The company’s full-year 2025 revenue jumped 51% year over year to reach $588 million compared to revenue of $390 revenue in 2024, according to its fourth-quarter and full-year financial results.” 
  • KFF lets us know,
    • “National spending on health has increased rapidly over time—rising to $5.3 trillion and 18% of GDP in 2024—and is projected to continue to do so into the future. Growth in health spending contributes to higher costs for families, employers, Medicare, Medicaid, and other payers. In 2025, average annual premiums for employer-sponsored family coverage reached $26,993, with workers paying $6,850 for their coverage, according to KFF’s annual survey of employers.  Hospital care accounted for nearly one-third of national health expenditures in 2024, and more than doubled in nominal terms over the preceding two decades, making hospitals a major driver of health spending growth over time.” * * *
    • “National health expenditures increased by $692 billion between 2022 and 2024, from $4.6 trillion to $5.3 trillion. During this period, spending on hospital care alone accounted for $277 billion of spending growth, or 40% of the total increase in national health spending (Figure 1). The large contribution of hospital care to overall health spending growth reflects the fact that hospital spending accounted for nearly a third of national health expenditures in 2022 (30%) and grew more quickly than national health expenditures overall in both 2023 (10.6% versus 7.4%) and 2024 (8.9% versus 7.2%).”
    • FEHBlog note — Hospitals and health systems are not included in the Break Up Big Medicine bill discussed above.
  • Beckers Hospital Review tells us,
    • “Dallas-based Tenet Healthcare reported $21.3 billion in revenue in 2025, up from $20.7 billion in 2024, as the system posted strong fourth-quarter results and outlined a positive outlook for 2026. For the fourth quarter, Tenet reported net operating revenue of $5.5 billion, compared to $5.1 billion during the same period in 2024.
    • “2025 extended Tenet’s track record of strong revenue growth, disciplined operations, improved margins and robust free cash flow generation,” Tenet Chair and CEO Saum Sutaria, MD, said in a Feb. 11 news release. “We see continued demand for acute care and ambulatory surgical services in our markets and are confident in our ability to execute on our strategy and achieve our full-year 2026 expectations.”
  • and
    • “There are 417 rural hospitals that are vulnerable to closure, according to a Feb. 10 report from Chartis, a healthcare advisory services firm. 
    • “Chartis’ Rural Hospital Vulnerability Index assesses more than a dozen indicators to identify which are statistically significant for determining the likelihood of closure.
    • “The number of overall rural hospitals vulnerable is down from 432 last year, but Chartis said there are “notable shifts at the state level.” In Tennessee, the percentage of vulnerable hospitals increased from 44% to 61%. In South Dakota, the percentage increased from 28% to 42%. Mississippi, which Chartis said has long been a “weak spot in the rural health safety net,” saw an improvement from 49% to 42%. Kansas also saw an improvement from 47% to 44%. 
    • “”Chartis’ analysis found that 17 states have 10 or more rural hospitals vulnerable to closure this year. Texas has the most with 50, followed by Kansas (44), Tennessee (27), Georgia (25), and Mississippi (24). These states are receiving a combined $1.1 billion in the first round of CMS’ Rural Health Transformation Fund initiative.”  
  • BioPharma Dive informs us,
    • “Shares of Gilead Sciences slid after the stock market closed Tuesday in spite of a fresh earnings report in which the company’s top products beat Wall Street forecasts.
    • “Gilead recorded $7.9 billion in product sales over the final three months of 2025, a 5% increase from the same period a year prior. Brian Abrahams, an analyst at RBC Capital Markets, called it a “strong commercial quarter” with “major beats” in Gilead’s HIV business, which was up 6% year-over-year.
    • “Biktarvy, a three-in-one pill for HIV treatment, and Descovy, a daily tablet often used to stave off infections from the virus, respectively brought in $4 billion and $819 million during the quarter. That’s higher than the roughly $3.84 billion and $720 million the average analyst had penciled in, according to Abrahams.”
  • MedTech Dive notes,
    • “Edwards said study data supporting earlier use of its Sapien heart valves to treat patients who have severe aortic stenosis without symptoms is changing clinical practice and helping to accelerate sales of the devices.
    • “The company on Tuesday posted a second consecutive quarter of double-digit sales growth in its transcatheter aortic valve replacement business.
    • “CEO Bernard Zovighian said momentum is coming from long-term data presented last fall confirming the durability of the Sapien valves and the “practice-changing” EARLY TAVR trial results that showed asymptomatic patients who had the procedure fared better than those who remained under clinical surveillance alone. Edwards is the only TAVR system with asymptomatic approval.”

Tuesday report

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, NIH, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare reports,
    • “Republicans on the House Judiciary Committee have subpoenaed eight insurers for documents outlining their measures to head off fraud related to Affordable Care Act subsidies.
    • “The information demands follow an attempt from the Trump administration over the summer to enact new guardrails on improper enrollments, which was paused by the courts amid ongoing litigation. The Republican committee heads said their inquiries could help unstuck that regulatory effort.: * * *
    • “The insurers who were sent a subpoena are: Blue Shield of California, Centene Corporation, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanente and Oscar Health.”
  • STAT News relates,
    • “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.”
  • The American Hospital Association News tells us,
    • “The AHA Feb. 10 released its 2026 Rural Advocacy Agenda, laying out the association’s key priorities for Congress, the administration, regulatory agencies and courts. The agenda is focused on flexible payment models; ensuring fair reimbursement and access to capital; commercial insurer accountability; bolstering the workforce; and protecting the 340B Drug Pricing Program.”
  • The Washington Post informs us,
    • “The American Medical Association and a leading public health research group focused on vaccines are teaming up to create a system to review vaccine safety and effectiveness, mirroring a role long played by the Centers for Disease Control and Prevention.
    • “The groups, which will operate independently from the federal government, say their work is needed because the CDC’s vaccine review process has “effectively collapsed.” The parallel effort will initially focus on reviewing immunizations for influenza, covid-19 and respiratory syncytial virus, or RSV, ahead of the coming fall respiratory season.
    • “The groups will not be making vaccine recommendations but will provide the evidence reviews to state health officials, clinicians and others making vaccine decisions.
    • “The nation’s largest physician organization and the Vaccine Integrity Project at the University of Minnesota will convene leading medical professional societies, public health groups and health care organizations to “ensure a deliberative, evidence-driven approach to produce the data necessary to understand the risks and benefits of vaccine policy decisions for all populations — the approach traditionally used by the federal government,” according to a joint statement announcing the effort Tuesday.”

From the Food and Drug Administration front,

  • Radiology Business lets us know,
    • “A new MRI system designed specifically for imaging of neonates and infants has just been cleared by the U.S. Food and Drug Administration. 
    • “Cincinnati-based Eyas Medical Imaging announced the clearance of its Ascent3T on Thursday. Eyas cited the clearance as the first in the world for a 3T neonate-specific MRI system.  
    • “Cincinnati Children’s Hospital played a pivotal role in the scanner’s design and development. Experts there observed over 1,700 infant MRI scans on prototypes to get a better idea of how to design the system so it could achieve diagnostic quality in real-world settings.
    • “We took great care in the design of the Ascent3T. Our goal is to transform neonatal care by bringing an unprecedented level of MR imaging and access to the most vulnerable patients when and where they need it,” MR physicist Charles Dumoulin, PhD, a professor of pediatrics and radiology at Cincinnati Children’s and the founder of Eyas Medical Imaging, said in an announcement.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration refused to review Moderna’s application to sell a new seasonal flu vaccine.
    • “The FDA sent Moderna a “refusal-to-file” letter earlier this month, saying the company’s study testing the vaccine wasn’t sufficient, and the agency wouldn’t take up the company’s request for approval to sell the shot, Moderna said Tuesday.
    • “In the letter, the FDA said Moderna failed during testing to compare its experimental flu vaccine to the best available vaccine on the market.
    • “Moderna said the FDA didn’t identify any concerns about the safety or effectiveness of the company’s experimental vaccine. The company said it was asking the agency for a meeting to discuss the matter.”
  • Fierce Pharma adds,
    • “A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi.”
  • Per an HHS news release,
    • “The U.S. Food and Drug Administration today launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food. The review will consider whether BHA is safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information. As part of this re-assessment, the agency issued a Request for Information (RFI) on the use and safety of BHA.
    • “This is part of the FDA’s broader efforts to proactively review chemical additives in the food supply. In May 2025, the FDA launched a strengthened program to review chemicals currently in the food supply. FDA identified BHA as a top priority for review. The FDA’s post-market assessment of BHA used in food is one of several ongoing post-market assessments under the agency’s enhanced systematic process for scrutinizing chemicals in our food supply.”

From the public health and medical / Rx research front,

  • The AHA News reports,
    • “There are 933 cases in the South Carolina measles outbreak, the state’s Department of Public Health reported Feb. 10. Of those, 859 cases are unvaccinated, 20 are partially vaccinated, 25 are vaccinated and the status of 29 cases is unknown. The agency said last week that in January there were more than 16,800 doses of the measles vaccine administered, a 72% increase compared to January 2025. The department said vaccination continues to be the best way to prevent measles and end the outbreak.”
  • The Wall Street Journal asks “Why Doctors Can’t Agree on How to Diagnose Alzheimer’s Disease.”
    • “Divergent diagnostic criteria is raising concerns that some patients are being misdiagnosed and unnecessarily treated.” * * *
    • “Dr. Gayatri Devi, director of Park Avenue Neurology in New York City, is a neurologist who says over the past year she has seen an increasing number of patients who were told they had Alzheimer’s disease when they didn’t. One patient, a human-resources executive, had erroneously been diagnosed with Alzheimer’s based on a faulty PET scan of his brain that had read positive for amyloid and his own fears of memory issues because he had missed an important meeting.” * * *
    • “Dr. Reisa Sperling is a neurology professor at Harvard Medical School who runs studies testing antiamyloid drugs in asymptomatic people with amyloid in their brain. She says the goal is early intervention. * * *
    • “She says the International Working Group’s criteria requiring cognitive impairment to diagnose Alzheimer’s disease is problematic, likening it to requiring someone with diabetes to wait until they have blindness or kidney failure to be diagnosed. “All disease begins before symptoms, and most diseases are better treated before people walk into your office with clear impairment,” Sperling says. 
    • “Devi says the psychological impact of being told you have Alzheimer’s when you don’t is profound. Until the medical community can better agree on how to both diagnose early Alzheimer’s disease and determine whether early treatment helps, patients should avoid unnecessary testing—especially with the advent of easily accessible blood tests.”
  • MedPage Today tells us,
    • “A large-scale, automated urinary incontinence (UI) screening and education program increased awareness, diagnosis, and treatment of the condition, researchers found.
    • “In a quality improvement study known as Identify, Teach, and Treat (IT2), Sarah Collins, MD, of the University of Chicago Pritzker School of Medicine, and colleagues asked women presenting for routine annual primary care visits a single question: “Do you have bothersome leakage of urine?”
    • “Those who answered “yes” were given the option to engage in an educational and interactive computer-based tool about UI and treatment options. Using the tool led to significant increases in practice-level rates of UI diagnosis and treatment, the researchers reported in JAMA Internal Medicine.”
  • Healio informs us
    • “Adolescents and young adults with type 1 diabetes who reported receiving help with managing their disease may have better glycemic outcomes as they transition from pediatric to adult care, researchers reported.
    • “In a study published in Diabetic Medicine, researchers analyzed baseline data from adolescents and young adults who enrolled in a randomized clinical trial to assess a behavioral intervention to support the transition from pediatric to adult care. After conducting four multiple regression models, researchers found that participants who said they received more help with managing their diabetes had better self-management skills and lower HbA1c.”
  • Per NIH news releases,
    • “National Institutes of Health (NIH) researchers have developed a digital replica of crucial eye cells, providing a new tool for studying how the cells organize themselves when they are healthy and affected by diseases. The platform opens a new door for therapeutic discovery for blinding diseases such as age-related macular degeneration (AMD), a leading cause of vision loss in people over 50.
    • “This work represents the first ever subcellular resolution digital twin of a differentiated human primary cell, demonstrating how the eye is an ideal proving ground for developing methods that could be used more generally in biomedical research,” Kapil Bharti, Ph.D., scientific director at the NIH’s National Eye Institute (NEI).”
  • and
    • “The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) study ,following a regular review by the Data Safety and Monitoring Board (DSMB).
    • The DSMB is an independent group of experts that regularly check if the study is safe. NIH’s National Institute of Neurological Disorders and Stroke, the trial’s funder, accepted the DSMB recommendation that CAPTIVA discontinue the low-dose rivaroxaban arm of the trial due to an increase in safety events and evidence of futility, a pre-specified stopping point to enable the study to end if early results showed the treatment is unlikely to help people. Rivaroxaban is a U.S. Food and Drug Administration-approved anticoagulant medication used to treat or prevent blood clots.
    • All study sites that have active participants randomized to the discontinued arm have received instructions for drug discontinuation. Study participants who have completed their evaluation of the discontinued arm will be contacted by the site where they received treatment. Participant safety remains NIH’s top priority.
  • Per BioPharma Dive,
    • “In experimental eczema shot from Nektar Therapeutics helped trial enrollees who’d already benefited from treatment maintain and even deepen their response over one year after being switched to a longer-lasting maintenance dose, the company said Tuesday.
    • “The data, if confirmed in additional testing, could give Nektar’s shot a competitive advantage over Regeneron and Sanofi’s Dupixent and Eli Lilly’s Ebglyss by offering deepening effects with less-frequent dosing. But Nektar also faces competition from many others advancing different types of injectables and oral medicines for the condition. 
    • “Nektar is planning a Phase 3 trial with a similar design that will allow responders to transition to a maintenance dose while others continue on with the initial regimen. If successful, the company expects to ask the Food and Drug Administration for approval in 2029.”
  • and
    • “An experimental, dual-acting weight loss pill from Hengrui Pharma and Kailera Therapeutics will advance into further testing after succeeding in a mid-stage study in China.  
    • “The drug is an oral version of ribupatide, an injectable therapy the two have already brought into Phase 3 development. In a Phase 2 study in 166 participants, that pill helped spur an average of as much as roughly 12% weight loss over 26 weeks, compared to about 2% for placebo recipients. More than half of those on the highest dose lost at least 10% of their body weight, and around 38% achieved at least 15% weight loss.
    • “Most treatment-related side effects were gastrointesinal and mild to moderate in nature. At the top two doses tested, vomiting was reported in as many as 11.4% and 7.5% of recipients, and nausea in 22.7% and 20%, respectively. Hengrui will “rapidly” move the drug into a Phase 3 trial in China, while Kailera plans to start a global mid-stage trial this year, the companies said.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS beat Wall Street’s expectations in the fourth quarter, but investors — unhappy that the healthcare giant didn’t change its outlook for 2026 — still sent CVS’ stock down after the company released results early Tuesday morning.
    • “Executives defended CVS’ 2026 guidance as achievable and indicative of the success of the company’s turnaround plan during a difficult time for insurers. The financial growth CVS outlined contrasts with some of its managed care peers, which expect revenue and earnings to contract this year.
    • “CEO David Joyner also said that CVS is in talks with the Federal Trade Commission in the agency’s high-profile lawsuit against major pharmacy benefit managers, following the FTC’s recent settlement with Cigna.” * * *
    • “Moreover, legislation passed earlier this month requiring more transparency and delinking compensation from drug prices in Medicare’s prescription drug benefit is manageable, and could lead to greater adoption of Caremark’s rebate-free model, Joyner said.
    • “What we’ve seen now is more clarity in terms of where the reform is coming from. The good news is, we know at least with the legislation how to operate and how to run our business,” Joyner said. “At least consistent with the PBM legislation, the tools that we’ve seen are essentially leaning into what we’ve been doing over the last couple years.”
  • Fierce Healthcare relates,
    • “With 2025 marking a “reset year for the industry,” Oscar Health put a focus throughout the year on setting the company up for the future, its top brass told investors Tuesday.
    • “Oscar’s insurance business is concentrated in the Affordable Care Act exchange market, and CEO Mark Bertolini said during the company’s fourth-quarter earnings call that plans across this space felt the squeeze as more Medicaid lives entered the pool and integrity measures drove changes in market dynamics.
    • “With that backdrop, Oscar priced its plans for 2026 to account for those program integrity changes, elevated utilization trends and higher morbidity among its membership, Bertolini said. He said the team also baked in an expectation that the advanced premium tax credits would run out as scheduled, which they did Jan. 1.
    • “We took decisive actions with a disciplined pricing, distribution and product strategy to go after profitable growth as competitors pulled back or exited the market,” he said.”
  • Kaufmann Hall tells us,
    • “Hospital performance settled into a “new normal” in 2025. Patient volumes continue to grow, and a persistent gap between gross and net operating revenue indicates an eroding payer mix and more uninsured patients.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.
    • “Key Takeaways
      • “Hospital performance settled into a “new normal” in 2025. While margins in 2025 were stronger compared to prior years, hospitals need to be strategic about diversifying services and managing expenses.
      • “Patient volumes continue to grow across all services. While outpatient volumes continue to increase, hospitals will likely have a greater proportion of high acuity patients with elevated costs of care.
      • “There is a persistent gap between gross and net operating revenue, alongside a rise in bad debt and charity care. This imbalance indicates an eroding payer mix, likely a higher proportion of government vs. private payers, and more uninsured patients.”
  • Beckers Hospital Review adds,
    • “The same financial pressures hospitals are facing are increasingly evident at the physician enterprise level, according to Kaufman Hall’s latest quarterly “Physician Flash Report,” which is based on data from more than 200,000 employed providers — physicians and advanced practice providers — across more than 100 specialties.
    • “Provider productivity continues to climb, even as reimbursement and compensation lag behind, according to the report. Provider productivity — measured by work relative value units per full-time equivalent — has increased 7% since 2023. Over the same period, provider compensation rose 6%, while reimbursement declined 1%, as measured by net patient revenue per provider wRVU.
    • “The imbalance is driving higher practice subsidies. 
    • “The median investment — or subsidy — per physician reached $315,358 in the fourth quarter of 2025, a 4% increase since 2023. Labor expenses also remain elevated, accounting for 84.4% of total physician practice costs.
    • “The amount of downstream revenue that a provider needs to generate to cover a practice’s investment is increasingly unsustainable in this current financial environment,” Matthew Bates, managing director and physician enterprise service line leader at Kaufman Hall, said in a Feb. 10 news release. “Providers are working more but are being paid less for their work. Patient demand is up, yet reimbursement is falling.”
  • Fierce Pharma points out,
    • “After ending 2025 with a strong fourth quarter, AstraZeneca management has doubled down on its ambitious “$80 billion by 2030” revenue target, outlining a roadmap to have more than 25 blockbuster medicines by the end of the decade.
    • “During AZ’s Q4 earnings call, CEO Pascal Soriot highlighted an “unprecedented catalyst-rich period.” With more than 100 ongoing phase 3 trials and over 20 late-stage readouts slated for 2026, AZ’s exec team used a big chunk of their time on the call taking inventory of key clinical programs.
    • “That large portfolio shows the value of diversification, again highlighting what Soriot called “low concentration risk.”
    • “It’s great to have one or two big products. [It] makes you very profitable and makes you look good,” Soriot said. “But if you lose one of those, as we’ve seen happen to some actors in the industry lately, it really becomes very painful, very quickly. So this diversification, both product-wise, but also geographically, is suddenly becoming more apparent as we drive growth through therapy areas but also through regions.”
    • “AZ capped 2025 with fourth-quarter revenues of $15.5 billion, which arrived slightly above analysts’ expectations, thanks mainly to the company’s oncology portfolio.”
  • Beckers Payer Issues ranks States by share of mental health treatment facilities that accept commercial insurance.
    • “Overall, 83% of mental health treatment facilities accept private insurance in the United States. 
    • “Wyoming has the greatest percentage of centers that take commercial insurance, whereas California and the District of Columbia have the lowest. 
    • “KFF reported the rate of mental health treatment facilities that accept various insurance types, relying on 2024 data from respondents. While a facility may report participation, not all facilities may be accepting new patients.”

Monday report

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Hill reports,
    • “The Trump administration on Monday proposed stripping the power of an independent board to review challenges from fired federal workers while barring employees from taking the matter to court.
    • “The new proposed rule would impact federal workers fired through a Reduction in Force (RIF), the process used at 22 different agencies last year as the Trump administration conducted widespread layoffs.
    • “If finalized, any federal worker fired in a future RIF would not be able to plead their case before the quasi-judicial Merit Systems Protection Board (MSPB), which last year found that some agencies had “engaged in a prohibited personnel practice” in firing the workers. 
    • “Instead, any challenges would be reviewed by the Office of Personnel Management (OPM), which last year alongside the Office of Management and Budget instructed agencies to begin RIFs.”
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) proposed regulations to lower health care costs, promote competition, and strengthen program integrity in the Federal and State-Based Health Insurance (Exchanges). The proposed Notice of Benefit and Payment Parameters for 2027 would crack down on fraud and misleading practices by agents and brokers, restore accountability for taxpayer-funded subsidies, and remove federal barriers that have limited plan innovation and driven up premiums—helping ensure coverage is more affordable and works better for consumers, taxpayers, and states.” * * *
    • “To review the proposed rule, visit https://www.federalregister.gov/d/2026-02769. 
    • “Public comments must be submitted by March 11, 2026. 
    • “To review the proposed rule fact sheet, visit https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-payment-parameters-2027-proposed-rule.” 
  • Bloomberg Law adds,
    • “The Notice of Benefit and Payment Parameters from the Centers for Medicare & Medicaid Services would allow certain plans that offer preset dollar amounts for care—such as indemnity plans—to meet the requirements of a “qualified health plan” under the ACA if they demonstrate a sufficient number of doctors would accept the plan’s payment terms.” * * *
    • “The rule likewise expands hardship exemptions to permit more individuals to buy “catastrophic” plans with the lowest level of cost-sharing and coverage, and allows catastrophic plan issuers to offer multi-year terms. The proposal would also permit plans with low deductibles and higher out-of-pocket costs
    • “The rule also reverses changes made under the Biden administration, including requiring insurers to offer standardized plan options that were meant to simplify choices.”
  • Healio observes,
    • “A voluntary program designed to help Medicare Part D beneficiaries manage drug costs[, which took effect last year,] could provide considerable benefit to people with cancer, according to study results.
    • “The Medicare Prescription Payment Plan (M3P) provides flexibility that may ease financial distress — particularly for those with limited or fixed incomes — and reduce the potential for cost-related treatment nonadherence, researchers concluded.”
    • “However, many patients and health care professionals are unaware of the program, according to Aryana Sepassi, PharmD, MAS, assistant professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.”

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
    • “After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
    • “The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.”
  • MedPage Today tells us,
    • “Oncology specialists should inform patients about a risk of serious toxicity related to dihydropyrimidine dehydrogenase (DPD) deficiency and should test for DPYD variants before starting treatment with capecitabine (Xeloda) and fluorouracil, the FDA announced.
    • “In a safety update communicationopens in a new tab or window, the agency noted that DPYD encodes DPD, which breaks down more than 80% of fluorouracil. Certain homozygous or compound heterozygous DPYD variants result in complete or near-complete absence of DPD activity, increasing the risk for serious, potentially fatal toxicities when exposed to capecitabine or fluorouracil, which are widely used in cancer treatment. Potential adverse reactions include mucositis, diarrhea, neutropenia, and neurotoxicity. The reactions also can occur in patients who have partial DPD activity.
    • “Capecitabine and fluorouracil, or 5-FU, are routinely used in treatment regimens for breast, colorectal, gastric, and pancreatic cancers.”
  • STAT New informs us,
    • “The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. 
    • “The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments.”
    • “Regenxbio had applied for accelerated approval, a type of conditional market clearance, based on RGX-121’s ability to significantly reduce in the short term a specific biomarker in cerebrospinal fluid believed to correlate with longer-term cognitive improvements in patients with the severe form of Hunter syndrome. 
    • “But the FDA, in its letter rejecting the therapy, raised questions about the appropriateness of using the surrogate biomarker, called CSF HS D2S6, as a predictor of clinical benefit. The agency also questioned the eligibility criteria  Regenxbio used to enroll patients into its clinical trial and the use of a natural history comparator arm, the company said.”  

From the judicial front,

  • Bloomberg Law reports,
    • “Medical providers are testing a new legal strategy to recoup unpaid arbitration awards as health insurers rack up victories in surprise billing disputes.
    • “The shift underscores the difficulties both sides face in arbitration under the No Surprises Act, which requires doctors and insurers to settle most unexpected out-of-network bills themselves rather than balance-billing the patient. The volume of disputes has exposed cracks in the system, leading to a series of lawsuits around ineligible claims, fraud, and unpaid awards.
    • “Courts have largely concluded that the law doesn’t grant doctors the right to sue over unpaid awards in most circumstances. Most recently, the US Supreme Court denied two air ambulance companies’ petition to hear their case after the US Court of Appeals for the Fifth Circuit ruled against them.
    • “Providers are now adapting their legal strategy by arguing insurance companies are guilty of improper denial of benefits under the Employee Retirement Income Security Act and unjust enrichment under common law. Hundreds of cases in the US District Court for the District of New Jersey were paused last month pending a decision on the amended claims in Rowe Plastic Surgery of NJ LLC v. Aetna Life Insurance Co .
    • “But the doctors are likely to face problems, at least in overcoming ERISA preemption on their unjust enrichment claims, said Leslie Howard, co-founder of Cohen Howard, a firm representing out-of-network providers.”
  • The American Hospital Association News relates,
    • “The 5th U.S. Circuit Court of Appeals Feb. 9 affirmed a district court ruling upholding Louisiana’s 340B contract pharmacy law. The state law prohibits drug companies from denying hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. Three drug companies — AbbVie, PhRMA and AstraZeneca — challenged the law, arguing that it was unconstitutional in several ways. “Rejecting those arguments, the appeals court held that Louisiana’s law was not preempted by federal law, did not violate the Fifth Amendment’s Takings Clause, did not violate the Constitution’s Contract Clause and was not unconstitutionally vague. “States regulate pharmacies — and the distribution of drugs to those pharmacies — every day,” the 5th Circuit explained. “Act 358 fits comfortably within that tradition.
    • “The AHA filed friend-of-the-court briefs supporting Louisiana’s law last year.” 
  • The Society for Human Resource Management notes,
    • “On Feb. 6, a federal appeals court vacated a preliminary injunction of two executive orders (EO) — EO 14151 on “Ending Radical and Wasteful Government DEI Programs and Preferencing” and EO 14173 on “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — finding they were not unconstitutional on their face. The court had previously stayed the injunction, pending appeal. This ruling was the first by a federal appeals court to find the two EOs facially constitutional. Both EOs focused on infrastructure inside the federal government with an emphasis on contracts and grants.
    • “EO 14173, issued Jan. 21, 2025, “was the most significant EO for the private sector” last year, said W. John Lee, an attorney with Morgan Lewis in Philadelphia. Established on May 19, 2025, the U.S. Department of Justice’s Civil Rights Fraud Initiative “is a direct result of the EO and is a prominent example of how it is reshaping federal enforcement of civil rights law.” EO 14151, issued Jan. 20, 2025, set the tone for EO 14173. EO 14173 reshaped compliance obligations for federal contractors and grantees. It also revoked EO 11246, ending EO-based affirmative action programs for women and minorities.
    • “On Jan. 21, 2025, U.S. Equal Employment Opportunity Commission (EEOC) Chair Andrea Lucas made it clear that the EEOC’s enforcement priorities had shifted in alignment with President Donald Trump’s EOs.
    • “While the 4th U.S. Circuit Court of Appeals vacated the injunction, it sent the case back to the district court for further proceedings and left open the possibility of challenges based on individual application of the EOs.”
  • The Wall Street Journal points out,
    • “A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become.
    • “In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hersof violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines.
    • “The pill from Hims & Hers threatened to undermine Novo Nordisk’s efforts to recapture momentum in the $70 billion weight-loss drug market by providing a lower-cost alternative to a Wegovy pill the Danish company recently launched.
    • “Novo Nordisk has been pulling out the stops to reclaim the momentum it lost to Eli Lilly in the booming market.” 

From the public health and medical / Rx research front,

  • Health Day tells us,
    • “Americans could be facing an uphill battle when it comes to protecting their heart health as they age, a new Cleveland Clinic poll reveals.
    • “Nearly 3 of 4 Americans (72%) feel confident in their ability to maintain heart health as they age, the survey found.
    • “But nearly as many (69%) also report that they have at least one known risk factor for heart disease.
    • “Worse, nearly 1 in 4 (24%) aren’t sure whether they are at increased risk for heart disease, according to the survey.
    • “Healthy aging is about prevention,” said Dr. Samir Kapadia, chair of cardiovascular medicine at the Cleveland Clinic.
    • “Heart disease often develops silently over decades, which is why staying active, understanding your risk factors, and addressing them early can make a profound difference in both quality of life and longevity,” Kapadia said in a news release.”
  • The American Medical Association lets us know “what doctors wish patients knew about the shingles virus.”
    • “If you’ve ever had chickenpox, then the virus that causes shingles is present in your body and can resurface at some point in the future. Find out more.”
  • The New York Times relates,
    • “If you think your daily doses of espresso or Earl Grey sharpen your mind, you just might be right, new science suggests.
    • “A large new study provides evidence of cognitive benefits from coffee and tea — if it’s caffeinated and consumed in moderation: two to three cups of coffee or one to two cups of tea daily.
    • “People who drank that amount for decades had lower chances of developing dementia than people who drank little or no caffeine, the researchers reported. They followed 131,821 participants for up to 43 years.
    • “This is a very large, rigorous study conducted long term among men and women that shows that drinking two or three cups of coffee per day is associated with reduced risk of dementia,” said Aladdin Shadyab, an associate professor of public health and medicine at the University of California, San Diego, who wasn’t involved in the study.”
  • NBC News relates,
    • “Bad,” or LDL, cholesterol is a major risk factor for heart disease and most people are screened for it as part of their yearly physicals.
    • There’s another marker in the blood that may be a better predictor of heart disease risk, a recent large review suggests. But it’s not part of routine blood testing.
    • “Apolipoprotein B (apoB) is a protein that attaches to harmful fat particles in the blood. The apoB protein is found on the surface of harmful lipoproteins like low density lipoprotein, or LDL, that contribute to heart disease. Since each one of the harmful particles contains one apoB molecule, testing for it essentially captures the overall number of harmful plaque-producing compounds.” * * *
    • “ApoB testing is hot among health influencers and increasingly touted in the commercial blood testing market. Recently, the Sweetgreen salad chain — which has tied itself to anti-seed-oil influencers — launched a collaboration with the testing company Function Health and is promoting apoB screening along with its menus.
    • “Dr. Michael Shapiro, a preventive cardiologist and the chair of the American Heart Association Council on Lipidology, Lipoprotein, Metabolism & Thrombosis, said that he typically uses an apoB test in select patients.” * * *
    • “In some cases, insurance may cover the test. If not, it typically costs around $70 at a lab.
    • “There aren’t clear guidelines for what target apoB levels should be. In healthy people, apoB values less than 90 mg/dL are typically considered acceptable, with some saying lower targets closer to 70 mg/dL may be more optimal for preventing heart disease.”
  • MedPage calls attention to
    • “Most women said they preferred clinic-based cervical cancer testing over at-home self-sampling, with demographics and life experiences shaping those preferences, a cross-sectional study indicated.
    • “In a nationally representative survey, 20.4% of women said they would prefer to do their own at-home self-sampling for cervical cancer screening, while 60.8% said they prefer clinic-based testing and 18.8% said they were uncertain on their preference, reported Sanjay Shete, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues in JAMA.
    • “The survey showed that women who had experienced prejudice or discrimination while receiving medical care had higher odds of preferring self-sampling at home (adjusted OR 1.94, 95% CI 1.16-3.22), while Black women had lower odds of preferring at-home self-sampling compared with their white peers (aOR 0.45, 95% CI 0.21-0.96).
    • “When women were asked why they preferred at-home self-sampling, privacy was the most common reason (54.9%), followed by time constraints (35.1%) and fear of embarrassment (33.4%).”
  • and
    • “The CDC’s Advisory Committee on Immunization Practices recently voted to stop recommending a universal dose of the hepatitis B vaccine at birth.
    • “An evidence review found that universal hepatitis B vaccination at birth is safe, effective, and protective for individual and public health.
    • “There was no improvement in safety or effectiveness with a delayed first dose of the hepatitis B vaccine.”
  • Per Genetic Engineering and Biotechnology News,
    • “In a study using gut microbiome samples from over 11,000 people across 39 countries, a single group of bacteria (CAG-170) has been found in higher numbers in the gut microbiomes of healthy people. CAG-170 remain unculturable in the lab, and are only identifiable from their genetic fingerprints.
    • “Further analysis of CAG-170 revealed the bacteria have the capacity to produce high levels of Vitamin B12 and enzymes that break down a wide range of carbohydrates, sugars, and fibers in our gut. The researchers suggest that Vitamin B12 supports other species of gut bacteria, rather than supporting the humans whose guts it is being produced in. CAG-170 could, in the future, be used as an indicator of our gut microbiome health or serve as the basis for the development of probiotics specifically designed to support and maintain healthy levels of CAG‑170 in the gut.”
  • Per Cardiovascular Business,
    • “An oral PCSK9 inhibitor from Merck is associated with significant reductions in low-density lipoprotein (LDL) cholesterol, according to new data published in The New England Journal of Medicine.[1] All PCSK9 inhibitors on the market today are injectable—an oral option that does not require needles could make a major impact on patient care. 
    • “Fewer than half of patients with established atherosclerotic cardiovascular disease currently reach LDL cholesterol goals,” lead author Ann Marie Navar, MD, PhD, an associate professor of cardiology at the University of Texas Southwestern Medical Center in Dallas, said in a statement. “An oral therapy this effective has the potential to dramatically improve our ability to prevent heart attacks and strokes on a population level.”
    • “Back in November, researchers presented initial findings from this study at the American Heart Association’s Scientific Sessions 2025 conference. Now, however, the analysis can be read in full.
    • “The CORALreef Lipids trial focused on nearly 3,000 heart patients with high LDL cholesterol who were randomized to either receive enlicitide, Merck’s experimental oral PCSK9 inhibitor, or a placebo. Two patients received the new drug for every one patient treated with a placebo.”
  • Per Radiology Business,
    • “A new MRI-specific artificial intelligence tool could significantly improve the diagnosis of neurological conditions in busy settings. 
    • “Developed by researchers at the University of Michigan, the tool can read brain scans in just seconds. The tool, named Prima, is a video language model that can simultaneously process video, images and text in real time. Experts involved in its development are hopeful it can help address the rising imaging volumes.
    • “As the global demand for MRI rises and places significant strain on our physicians and health systems, our AI model has potential to reduce burden by improving diagnosis and treatment with fast, accurate information,” said senior study author Todd Hollon, MD, a neurosurgeon at U-M Health. 
    • “Researchers trained Prima using more than 200,000 MRI exams collected at the university over several decades. Imaging data were included alongside patients’ medical histories and clinical indications for the scans. The team tested the model on more than 30,000 brain studies over a one-year period. Unlike earlier AI tools that focus on just one disease, Prima was designed to analyze all available imaging and clinical information at once, similar to how a radiologist reviews a case, giving it broad applicability.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Kaiser Permanente nearly tripled its operating income last year, even as the integrated healthcare conglomerate weathered rising expenses.
    • “Kaiser, which recorded results alongside its subsidiary Risant Health, recorded operating income of $1.4 billion last year, up from $569 million in 2024 as the nonprofit continued to invest in operational improvements, according to earnings results released last week. 
    • “Still, expenses rose by more than $11 billion last year as Kaiser said rising medication costs and other line items made providing care more expensive.”
  • Beckers Hospital Reviews identifies eleven rapidly growing health systems.
  • BioPharma Dive relates,
    • “Eli Lilly will acquire biotechnology startup Orna Therapeutics, saying Monday it will pay up to $2.4 billion to buy the privately owned company and a technology able to reprogram immune cells within the body.
    • “The Indiana-based drugmaker didn’t disclose how much upfront cash it’s shelling out for Orna, which specializes in “circular” RNA medicines that are believed to be more stable and easier to pair with the lipid nanoparticles used for delivery. But it noted in its statement that it intends to use Orna’s technology to develop cell therapies for autoimmune conditions.
    • “In announcing the deal, Lilly cited its interest in Orna’s lead project, which instructs immune cells to latch onto B cells that are attacking patients’ tissue in inflammatory diseases. The company presented data from preclinical studies at the American Society for Hematologymeeting in December that it’s using to support advancing into Phase 1 studies.”
  • and
    • “Japan’s largest drug company is teaming up with an artificial intelligence specialist to find new medicines for cancer and other diseases, through a deal that could be worth more than $1.7 billion.
    • “Announced Monday, the multiyear collaboration grants Takeda Pharmaceutical access to two technologies at Iambic Therapeutics. The first is an AI-driven platform used to discover and develop new drugs. The second is a model meant to predict how proteins will interact with certain receptors.
    • “The companies haven’t disclosed the deal’s upfront cost, nor any specific disease targets. The focus, though, will be on small molecule drugs for cancers and conditions rooted in the digestive or immune systems. Iambic will get milestone payments based on the partnership’s level of success, and is also eligible to receive royalties on net sales of any products it generates.”
  • Per Beckers Payer Issues,
    • “Patients who take advantage of zero-cost preventive screenings see better health outcomes and reduced spending, according to January research from BCBS Association and Blue Health Intelligence.
    • “The groups reviewed claims data of BCBS members with breast or colorectal cancer. The research pointed to lower likelihood of invasive tests and treatment.
    • “Eighty-one percent of members who were diagnosed with colorectal cancer through a preventive screening were classified in an early stage, compared to a 73% rate overall. For breast cancer, that figure was 86% during preventive screening. The early-stage rate was 82% overall.” 
  • Per an Institute of Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
    • “IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.”

Weekend update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–

Happy Super Bowl Sunday!

  • The House Energy Commerce Committee health subcommittee holds a hearing on February 11 with Pharma and PBM executives.
  • Fierce Healthcare adds,
    • “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. 
    • “Since the COVID-19 pandemic, virtual providers like Omada Health, 9am Health and Amwell have entered the business on temporary authority, much like other Medicare telehealth services.” 
  • Under the budget package, the Homeland Security appropriations bill remains under a continuing resolution which expires on February 13.
  • Roll Call lets us know,
    • “With no signs of tangible progress in negotiations over changes to immigration enforcement policies, the main question may be whether House members and senators can muster the votes needed for another short-term funding extension just for DHS.
    • “Both chambers of Congress are expected to be on recess next week for Presidents Day. The holiday weekend overlaps with the annual Munich Security Conference, which runs Feb. 13-15 and typically attracts a large congressional delegation.
    • “Senate Majority Leader John Thune, R-S.D., who is not traveling to Munich this week, suggested the Senate may need to be in session if the Homeland Security funding is not resolved.”

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “Hims & Hers has abandoned plans to sell a compounded version of Novo Nordisk’s weight loss pill following backlash from U.S. regulators and the threat of a federal investigation. 
    • “In a short statement posted on the social media platform X Saturday, Hims said that, after “constructive conversations with stakeholders across the industry,” it “decided to stop offering access” to the treatment. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.” 
    • “The sudden turn quickly ends, for now, plans by the telehealth company to launch a copycat form of Novo’s “Wegovy” pill. Hims had announced those plans on Thursday and, in doing so, quickly drew legal threats from Novo as well as swift action from the Food and Drug Administration.” 

From the public health and medical / Rx research front,

  • Clinical Advisor reports,
    • “Measles is now extending beyond families with young children, with outbreaks reported on college campuses and communities across the country.
    • “At least 12 people have tested positive for measles at Ave Maria University in Florida, near Naples, since January 29, according to local officials. Three people were taken to the hospital.
    • “A student at the University of Wisconsin-Madison also tested positive after traveling overseas.
    • “Earlier this year, Clemson University in South Carolina confirmed a measles case linked to someone with ties to the school.
    • “It takes only 3 cases of measles for health officials to declare an outbreak.
    • “So far in 2026, at least 17 states have reported infections, according to the US Centers for Disease Control and Prevention (CDC).”
  • CNN tells us,
    • “We often discuss depression and dementia separately, although scientists have long observed a connection between the two: People with depression appear to have a higher likelihood of developing dementia later in life.
    • “A new study published in The Lancet Psychiatry adds an important twistin untangling that relationship and looks beyond depression as a single diagnosis. By focusing on specific symptoms, the research raises a more precise and potentially more useful question: Could certain symptoms in midlife signal greater vulnerability to dementia decades later? And if so, what should people and clinicians do with that information now?”
    • The CNN reporter interviews CNN wellness expert Dr. Leana Wen about the study.
  • Medscape informs us,
    • “As GLP-1s continue to surge in demand, older patients in your practice may inquire about these medications for their weight-loss efforts. Although they are known to improve conditions such as high cholesterol and obesity and help with the management of type 2 diabetes, certain precautions should be considered for patients older than 65 years.
    • “Older adults often do their own research on wellness trends. If they ask about GLP-1 medications, knowing clinical and science-based facts can keep them informed and safe. Some experts say these medications and this patient population should be carefully considered.
    • “[In the article,] Yuval Pinto, MD, DABOM, assistant professor of medicine and part of the Healthful Eating, Activity & Weight Program at Johns Hopkins School of Medicine in Baltimore, laid out some of the risks.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Two years ago, a GLP-1 prescription could cost an uninsured patient more than $1,000 a month. Today, Novo Nordisk’s NOVO.B Wegovy pill starts at just $149 through cash-pay programs. 
    • “In the world of Big Pharma, this is unheard of. 
    • “Typically, drug prices climb or plateau until generics arrive years later. That trend should be even stickier in a duopoly. Yet the obesity market has turned traditional pharma economics upside down. As Leerink analyst David Risinger notes, there isn’t a comparable precedent for this level of price erosion in the industry’s history.” * * *
    • The question both companies [Novo and Lilly] are now racing to answer is just how elastic consumer demand is in the obesity market. Lower prices are clearly unlocking growth in demand, especially in the cash-pay market. As Novo Nordisk Chief Financial Officer Karsten Munk Knudsen argued in an interview this week, this isn’t a price war, so much as a search for the price points that open the floodgates of access.
  • The New York Times lets us know “How to Tell if You Will Save Money Using TrumpRx.”
    • “People may be able to pay less for prescriptions with their insurance rather than via the new government website. The Trump drugstore is meant to help people buy medications using their own money.”
  • Beckers Payer Issues notes,
    • “Elevance Health bid on 11 national accounts in competing Blue Cross Blue Shield markets last year and won nine of them, the company said on its 2025 earnings call with investors, offering the first look at how a landmark antitrust settlement is reshaping competition within the Blues ecosystem.
    • “This is the first year that we’ve had the opportunity for employers in competing geographies against us who could actually quote with our organization if they wanted,” Morgan Kendrick, Elevance’s president of commercial and specialty health benefits, said Jan. 28.
    • “The provision, known as the “second blue bid,” stems from a $2.67 billion settlement that resolved allegations dating back to 2012 that BCBS companies conspired to divide up markets and avoid competing with one another, thereby driving up costs for consumers. Among other changes, the settlement struck down a rule that required large employers to work with the BCBS insurer covering the geography where the employer is headquartered.
    • “Now, for certain large national accounts, employers can solicit bids from any BCBS plan in the country, not just the one licensed in their service area. Elevance’s 9-for-11 record is the first concrete data point on how the settlement is reshaping competition among Blues plans, but industry observers say the effects could stretch beyond one selling season.
    • “Ari Gottlieb, a consultant to insurers and owner of A2 Strategy, told Becker’s the provision will primarily benefit BCBS plans with the existing scale and technology to compete nationally.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy front,

  • The Wall Street Journal reports,
    • “After months of partisan wrangling, a temporary extension on Tuesday of legislation aimed at encouraging firms to share cyberattack intelligence with Washington might be too little, too late for corporate cybersecurity leaders. 
    • “The seesaw effect we saw last year has eroded the trust that intel sharing needs to be built on,” said Timothy Youngblood, an investor who led cybersecurity teams at T-Mobile, McDonald’s and Kimberly-Clark. Before providing sensitive details of a data breach or ransomware attack, companies need to be assured “they will not have the information used against them,” Youngblood said.
    • “The Cybersecurity Information Sharing Act, or CISA, provides liability and antitrust protections for companies that share attack data with federal agencies. Created in 2015 with a 10-year sunset clause, the act lapsed twice over the past four months as lawmakers clashed over proposed revisions. It was extended this week [to September 30, 2026] as part of a broader spending bill approved by Congress and signed by President Trump.  
    • “But an eight-month shelf life—and on-again off-again status—is unlikely to encourage hacked companies to risk legal or reputational damage by sharing sensitive data, especially in the wake of costly downtime, cybersecurity experts said. Staffing and resource cuts over the past year at the federal Cybersecurity and Infrastructure Security Agency, which shepherds private-public intelligence sharing, is adding to their concerns, they said.
    • “Temporary extensions are Band-Aids,” said Kevin Greene, public sector chief cybersecurity technologist at security firm BeyondTrust. Prolonged uncertainties, he said, will “absolutely create some friction in information sharing.”
  • Cyberscoop relates,
    • “The Trump administration needs help from industry to reduce the cybersecurity regulatory burden and to back important cyber legislation on Capitol Hill, among other areas, National Cyber Director Sean Cairncross said Tuesday.
    • “You know your regulatory scheme better than I do: Where there’s friction, where there’s frustration with information sharing, what sort of information is shared, the process through which it’s shared,” he said. “It is helpful for us to hear that and have that feedback so that we can address it, engage it and try to make it better.”
    • “The Trump administration is interested in being a partner with industry rather than a “scold,” Cairncross said at an Information Technology Industry Council event. The Biden administration sought to impose more cybersecurity rules on the private sector than prior administrations.”
  • Cybersecurity Dive adds,
    • “Cairncross’s comments come as the White House prepares to unveil its five-page national cybersecurity strategy, which will focus heavily on streamlining regulations to reduce the burden on industry, including critical infrastructure organizations.
    • “The White House wants to revise the current patchwork of cybersecurity regulations “so that form follows function rather than [the rules being] a compliance checklist,” said Cairncross, who has led the relatively new Office of the National Cyber Director since August.” * * *
    • “Cairncross did not provide a timeline for the strategy’s release, but he said the White House would publish it “sooner rather than later.” The goal of the brief document, he explained, is “to point a direction for the USG to go so resources and effort can be lined up.”
  • and
    • “Governments should work closely with the private sector when designing and detailing their national cybersecurity strategies, a prominent think tank said in a report published on Monday.
    • “Active participation from the private sector, particularly large technology, telecommunications, and cybersecurity firms, is critical throughout the strategy’s development,” the Center for Cybersecurity Policy and Law (CCPL) said in its white paper. “The private sector can help not only support but also deliver on the government’s cybersecurity objectives and is key to a secure and resilient nation.”
  • and
    • “The Trump administration is making progress on creating an information sharing and analysis center for the AI industry to improve its ties with the government as AI cyber threats proliferate, a U.S. official said on Tuesday.
    • “The administration is absolutely committed to making sure that we’re supporting this industry, making sure that we’re going to foster information sharing,” Nick Andersen, executive assistant director for cybersecurity at the Cybersecurity and Infrastructure Security Agency, said during a talk at an event hosted by the Information Technology Industry Council. “We just want to make sure we take the opportunity to get that relationship right.”
  • Federal News Network shares five updates on the Trump Administration’s cybersecurity agenda.
    • Six-pillar national cyber strategy
    • CIRCIA update
    • AI-ISAC in development
    • AI security policy framework
    • CIPAC replacement coming soon?
  • DefenseScoop notes,
    • “Marine Corps Maj. Gen. Lorna Mahlock was confirmed by the Senate on Friday evening [January 30] as deputy commander of U.S. Cyber Command, where she could have an outsized influence as the organization prepares for new leadership and other major changes.
    • “She was nominated for the position by President Donald Trump.
    • “Her Senate confirmation, which happened via voice vote, means she’ll also pin on a third star and become a lieutenant general.
    • “Mahlock brings deep cyber knowledge and background to her new role.”
  • Per Cybersecurity Dive,
    • “The Federal Communications Commission is warning telecommunications companies to regularly patch their systems, enable multifactor authentication and segment their networks to avoid falling victim to ransomware attacks.
    • “Recent events show that some U.S. communications networks are vulnerable to cyber exploits that may pose significant risks to national security, public safety, and business operations,” the FCC’s Public Safety and Homeland Security Bureau said in a Jan. 29 alert.”

From the cybersecurity vulnerabilities and breaches front.

  • Cyberscoop reports,
    • “Cybersecurity and Infrastructure Security Agency order published Thursday [February 4, 2026] directs federal agencies to stop using “edge devices” like firewalls and routers that their manufacturers no longer support.
    • “It’s a stab at tackling one of the most persistent and difficult-to-manage avenues of attack for hackers, a vector that has factored into some of the most consequential and most common types of exploits in recent years. New edge-device vulnerabilities surface frequently.
    • “Under the binding operational directive CISA released Thursday, federal civilian executive branch (FCEB) agencies must inventory edge devices in their systems that vendors no longer support within three months, and replace those on a dedicated list with supported devices within one year.”
  • The American Hospital Association News tells us,
    • “The National Institute of Standards and Technology Feb. 2 published details on a critical vulnerability that impacted Notepad++, a free, open-source text and source code program widely used by several industries, including health care. The vulnerability impacted an update component affecting iterations of the program prior to version 8.8.9, and allowed attackers to gaining access to and disrupt the update process. According to the program’s developer, attacks that occurred from June to November 2025 were likely executed by a sophisticated nation-state threat actor.”
  • Cybersecurity Dive informs us,
    • “Cybercrime “began its shift toward an AI-driven future” in 2025, the security firm Malwarebytes said in a report published Tuesday that charted AI’s influence on the rapidly growing hacking ecosystem.
    • “AI is making cyberattacks faster and more effective through deepfakes, vulnerability discovery, autonomous ransomware attacks and growing connectivity between AI models and penetration testing tools, according to the report.
    • “Malwarebytes urged businesses to “shrink their attack surfaces, harden identity systems, close blind spots, accelerate remediation, and adopt continuous monitoring.”
  • and
    • “Hackers working for an Asian government have breached at least 70 government agencies and critical infrastructure organizations in 37 countries over the past year as part of an espionage campaign likely aimed at collecting information about rare earth minerals, trade deals and economic partnerships, Palo Alto Networks said in a reportpublished on Thursday.
    • “While this group might be pursuing espionage objectives,” researchers with the company’s Unit 42 group wrote in the report, “its methods, targets and scale of operations are alarming, with potential long-term consequences for national security and key services.”
    • “The security firm provided indicators of compromise and described the threat actor’s techniques and infrastructure.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • February 3, 2026
      • CVE-2021-39935 GitLab Community and Enterprise Editions Server-Side Request Forgery (SSRF) Vulnerability
        • Cyber Press discusses this KVE here.
      • CVE-2025-40551 SolarWinds Web Help Desk Deserialization of Untrusted Data Vulnerability
        • Cybersecurity Dive discusses this KVE here.
      • CVE-2019-19006 Sangoma FreePBX Improper Authentication Vulnerability
      • CVE-2025-64328 Sangoma FreePBX OS Command Injection Vulnerability 
        • The Hacker News discusses these KVEs here.
    • February 5, 2026
      • CVE-2025-11953 React Native Community CLI OS Command Injection Vulnerability
        • Security Wek discusses this KVE here.
      • CVE-2026-24423 SmarterTools SmarterMail Missing Authentication for Critical Function Vulnerability
        • Bleeping Computer discusses this KVE here.
  • Dark Reading points out, “CISA Makes Unpublicized Ransomware Updates to KEV Catalog
    • “A third of the “flipped” CVEs affected network edge devices, leading one researcher to conclude, ‘Ransomware operators are building playbooks around your perimeter.'”
  • Cyberscoop adds,
    • “Attackers are again focusing on a familiar target in the network edge space, actively exploiting two critical zero-day vulnerabilities in Ivanti software that allows administrators to set mobile device and application controls. 
    • “The vulnerabilities — CVE-2026-1281 and CVE-2026-1340 — each carry a CVSS rating of 9.8 and allow unauthenticated users to execute code remotely in Ivanti Endpoint Manager Mobile (EPMM). Ivanti did not say when the earliest known date of exploitation occurred but warned that a “very limited number of customers” were attacked before it disclosed and addressed the defects Thursday [January 29, 2026]. * * *
    • “The Cybersecurity and Infrastructure Security Agency has flagged 31 Ivanti defects on its known exploited vulnerabilities catalog since late 2021. At least 19 defects across Ivanti products have been exploited in the past two years. 
    • “The agency added CVE-2026-1281 to the catalog Thursday, but not CVE-2026-1340. Both defects have been exploited, according to watchTowr. Yet, a spokesperson for Ivanti said the vulnerabilities have not been chained together for exploitation.
    • “The latest code-injection vulnerabilities demonstrate attackers are focusing on EPMM in particular of late. Ivanti disclosed a separate pair of vulnerabilities in the same product in May 2025.” 
  • Cybersecurity Dive informs us,
    • “Two months after a critical vulnerability was disclosed in React Server Components, researchers warn of a significant change in threat activity targeting the flaw. 
    • “The original vulnerability, tracked as CVE-2025-55182, allows an unauthenticated attacker to achieve remote code execution due to unsafe deserialization of payloads. 
    • “The initial wave of attacks in December led to hundreds of systems being compromised as state-linked threat groups and other actors engaged in widespread exploitation. The vulnerability, dubbed React2Shell, has been targeted in a wide range of industries since it was discovered in late November.
    • “Researchers from GreyNoise on Monday reported a distinctive change over the prior seven days, as more than half of the threat activity now emanated from only two IP addresses, according to a blog post. Before the change, there were 1,083 unique sources linked to threat activity, according to researchers.
    • “GreyNoise said its sensors detected more than 1.4 million attempts to exploit CVE-2025-55182 during the seven-day period.
    • “Researchers warned the exploitation appears to be focused on the developer community.” 
  • Per Dark Reading,
    • “Threat actors are using a forensic tool’s Windows kernel driver to kill security products, despite the fact the driver’s digital certificate was revoked more than a decade ago.
    • “In a blog post Wednesday, security researchers at Huntress detailed how the company responded to an intrusion earlier this month in which the threat actor used compromised SonicWall SSL VPN credentials for initial access to the victim’s network. But the real kicker was how the attacker avoided detection: they weaponized the Windows kernel driver of a legitimate forensic toolset called EnCase to disable security products across the network.”
    • “The attack technique is known as bring-your-own-vulnerable-driver (BYOVD), which involves taking advantage of the elevated privileges and kernel-level access of a driver to terminate security processes before an intrusion is detected. Threat actors have increasingly used drivers to disable endpoint detection and response (EDR) platforms, often in ransomware attacks; these tools are commonly known as EDR killers.”  
  • Per SC Media,
    • “More than 300 malicious OpenClaw skills hosted on ClawHub spread malware including the Atomic macOS Stealer (AMOS), keyloggers and backdoors, Koi Security reported Sunday.  
    • “OpenClaw, formerly known as Moltbot and Clawdbot, is an open-source AI agent that has recently gained significant popularity as a personal and professional assistant.
    • “ClawHub is an open-source marketplace for OpenClaw “skills,” which are tools OpenClaw agents can install to enable new capabilities or integrations.
    • “Koi Security Researcher Oren Yomtov discovered the malicious skills in collaboration with his own OpenClaw assistant named Alex, according to Koi Security’s blog post, which is written from Alex’s perspective.
    • “Yomtov and Alex audited all 2,857 skills available on ClawHub at the time of their investigation, and discovered that 341 were malicious, with 335 seemingly tied to the same campaign.”
  • Per Security Week,
    • “The big takeaway from 2026 onward is the arrival and increasingly effective use of AI, and especially agentic AI, that will revolutionize the attack scenario. The only question is how quickly.
    • ‘Michael Freeman, head of threat intelligence at Armis, predicts, “By mid-2026, at least one major global enterprise will fall to a breach caused or significantly advanced by a fully autonomous agentic AI system.”
    • “These systems, he continues, “use reinforcement learning and multi-agent coordination to autonomously plan, adapt, and execute an entire attack lifecycle: from reconnaissance and payload generation to lateral movement and exfiltration. They continuously adjust their approach based on real-time feedback. A single operator will now be able to simply point a swarm of agents at a target.”

From the ransomware front,

  • Bleeping Computer reports today,
    • “A major U.S. payment gateway and solutions provider says a ransomware attack has knocked key systems offline, triggering a widespread outage affecting multiple services.” * * *
    • “BridgePay Network Solutions confirmed late Friday that the incident disrupting its payment gateway was caused by ransomware.
    • “In an update posted Feb. 6, the company said it has engaged federal law enforcement, including the FBI and U.S. Secret Service, along with external forensic and recovery teams.
    • “Initial forensic findings indicate that no payment card data has been compromised,” the company said, adding that any accessed files were encrypted and that there is currently “no evidence of usable data exposure.”
  • The Rhode Island Current tells us,
    • “A state vendor and major provider of workers’ compensation insurance in Rhode Island confirmed it was the victim of a cyberattack in January.   
    • “The Beacon Mutual Insurance Company posted about the Jan. 14 incident to its website around noon Thursday, following inquiries from Rhode Island Current earlier in the day. The requests for comment were prompted by Beacon’s appearance on public websites that list and track recent reports of ransomware — a genre of malware characterized by making users’ files encrypted and inaccessible unless they pay a price.
    • “Yes, this was a ransomware attack,” Michelle N. Pelletier, the assistant vice president of marketing and communications at the Warwick company, confirmed over email late Thursday afternoon.
    • “But Pelletier added that not all was lost, and that the company’s production environment — or the live systems that users interact with directly — remained safe from harm.  
    • “Fortunately, our production environment was not encrypted, and we were able to resume normal operations on January 20,” Pelletier wrote.”  
  • Security points out,
    • “If battling ransomware isn’t challenging enough, these attacks have undergone a significant metamorphosis, with attackers shedding their encryption-based model for one of pure exfiltration. The result? A more stealthy, discreet approach that successfully bypasses traditional defenses to snatch sensitive data and employ a double or triple extortion scheme. 
    • “With pure exfiltration, businesses don’t realize they’re a victim until it’s too late.” 
  • Security Week adds,
    • “Data allegedly pertaining to over 5 million Panera Bread customers has emerged online after hackers failed to extort the US bakery-cafe chain.
    • “The ShinyHunters extortion group has claimed the theft of roughly 14 million records from Panera Bread, after compromising a Microsoft Entra single-sign-on (SSO) code.
    • “The attack falls in line with recent ShinyHunters attacks that rely on voice phishing (vishing) and SSO authentication to access victim organizations’ cloud-based software-as-a-service (SaaS) environments.
    • “Last week, ShinyHunters published on its Tor-based leak site a 760GB archive allegedly containing the sensitive information stolen from Panera Bread.
    • “According to the data breach notification site Have I Been Pwned, the data was leaked after the hackers failed to extort the food chain.
    • “The archive includes 5.1 million unique email addresses and likely impacts as many Panera customers. Associated information such as names, addresses and phone numbers was also present in the leak.”
  • Security.com lets us know,
    • “A recent Black Basta attack campaign was notable because the ransomware contained a bring-your-own-vulnerable-driver (BYOVD) defense evasion component embedded within the ransomware payload itself.
    • “Normally the BYOVD defense evasion component of an attack would involve a distinct tool that would be deployed on the system prior to the ransomware payload in order to disable security software. However, in this attack, the vulnerable driver (an NsecSoft NSecKrnl driver) was bundled with the ransomware itself. 
    • “BYOVD is by far the most frequently used technique for defense impairment these days. Generally, attackers will deploy a signed vulnerable driver to the target network, which they then exploit to elevate privileges and disable security software. Since the vulnerable drivers operate with kernel-mode access, they can be used to terminate processes, making them an effective tool for disrupting security measures. In most cases, the vulnerable driver is deployed along with a malicious executable, which will use the driver to issue commands.”
  • Bleeping Computer relates,
    • “Ransomware operators are hosting and delivering malicious payloads at scale by abusing virtual machines (VMs) provisioned by ISPsystem, a legitimate virtual infrastructure management provider.
    • “Researchers at cybersecurity company Sophos observed the tactic while investigating recent ‘WantToCry’ ransomware incidents. They found the attackers used Windows VMs with identical hostnames, suggesting default templates generated by ISPsystem’s VMmanager.
    • “Diving deeper, the researchers discovered that the same hostnames were present in the infrastructure of multiple ransomware operators, including LockBit, Qilin, Conti, BlackCat/ALPHV, and Ursnif, as well as various malware campaigns involving RedLine and Lummar info-stealers.”
  • Per Dark Reading,
    • “The operators of DragonForce, a ransomware-as-a-service outfit that first surfaced in 2023, appear to be drawing heavily from the organized crime playbook, creating a cartel and attempting to bring mafia-style territorial organization — and a bit of muscle — to the ransomware ecosystem.
    • “A detailed analysis by LevelBlue showed the group has recently shifted its business model to one where customers — or affiliates — of its service can create their own brands while still operating under a blossoming DragonForce cartel umbrella.” * * *
    • “DragonForce has established itself as a relatively major player in the ransomware ecosystem since launching activities in 2023. Though not as big as rivals like Akira and Qilin, it has commanded some attention for its aggressive marketing and outreach. As of July 2025, the company had notched at least 250 victims based on its data leak site, according to Check Point Research.”

From the cybersecurity defenses front,

  • Cyberscoop reports,
    • “Following a series of high-profile cyberattacks, boards of directors are now requiring their organizations to take greater responsibility for the risks posed by enterprise resource planning (ERP) systems pose after a series of high-profile cyberattacks. The Jaguar Land Rover (JLR), incident in Sept. 2025 illustrates the severe consequences of such attacks. The cyberattack forced JLR to halt production for six weeks, making it the costliest cyberattack in Britain’s history. The company’s revenue declined 24 percent that quarter, accounting for potentially over a  $1.2 billion drop in earnings, and subsequently reported a 43.3% wholesale sales volume drop the following quarter.
    • “For decades, organizations have treated ERP systems like SAP as back-office workhorses. However, the JLR incident—carried out by executed by the cybercrime group ShinyHunters —has thrust ERP systems into the spotlight. That shift in attention is critical: today, 90% of the Fortune 500 use SAP, making these systems “crown jewel” assets that require the highest level of protection.
    • “The threat is escalating. A recent Google Cloud Security report forecasts that ransomware operations specifically designed to target critical enterprise applications such as ERP systems will emerge in 2026, forcing organizations to make quick ransom payments and sacrifice business resilience. 
    • “In our roles as board members, advisers, and cybersecurity CEOs, we’re witnessing a fundamental shift in how organizations approach ERP security: the conversation has moved from compliance to survival. Organizations are grappling with critical question: Who owns the risk? What is our recovery time? Can we patch critical ERP vulnerabilities within 72 hours? Do we have visibility inside the application?”
  • Help Net Security explains where NSA zero trust guidance aligns with enterprise reality.
  • This HHS Inspector General’s report points out “Security Controls to Enhance Its Ability to Prevent and Detect Cyberattacks.”
  • Tech Target describes “five steps to ensure HIPAA compliance on mobile devices.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, Congress, COVID-19, FDA, Generative AI, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reports,
    • “Mehmet Oz arrived on Capitol Hill last week to pitch Republicans on an idea to codify into law President Trump’s drug-pricing model, which ties U.S. pharmaceutical costs to lower prices typically paid abroad.
    • “Oz, the Centers for Medicare and Medicaid Services administrator, could sense the skepticism from GOP senators—members of the Finance Committee—as they raised concerns about industry backlash and a potential chilling effect on innovation.
    • “You read the room,” Oz said in an interview. “When’s the right time to tell them they need to do something different?”
    • “The move marked the opening effort of the administration’s push to advance the president’s planahead of the midterm elections, as healthcare costs have become a top voter concern. While Trump has proposed sending money directly to Americans through Health Savings Accounts to ease those costs, that discussion was absent from Oz’s talks with Republicans, he said.
    • “That’s not the most important issue for us,” said Oz, the former television host and celebrity surgeon widely known as Dr. Oz. He emphasized making sure that pricing deals reached under Trump with more than a dozen pharmaceutical companies endure beyond his time in office.”
  • and
    • “The White House on Thursday launched its drug-pricing website, dubbed TrumpRx, the culmination of efforts by the administration to bring down pharmaceutical costs for some consumers.
    • “When it launched, it had roughly 40 drugs available, including obesity treatments Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and infertility treatments such as Gonal-F from EMD Serono. The prices for the drugs on TrumpRx were generally much lower than their sticker price, with President Trump touting some discounts of hundreds of dollars a month. The website, TrumpRx.gov, allows customers to search for specific medicines and purchase them through a manufacturer’s direct-to-consumer site, or in some cases gives users coupons that they can present at certain pharmacies.” * * *
    • “The website likely won’t have a substantial impact on the amount most Americans pay for their prescriptions, as most of Americans are insured—either through private or government plans—and are likely to get a better deal on the drugs via their coverage. The roughly 27 million Americans who are uninsured are those most likely to benefit from the direct-to-consumer offerings.” 
  • Here is a link to the White House’s fact sheet on TrumpRx.
  • Govexec tells us,
    • “The U.S. Postal Service on Thursday reported that it experienced a net loss of nearly $1.3 billion in the first quarter of fiscal 2026, as there continues to be a lack of consensus among postal leaders, stakeholders and lawmakers about how to fix the agency’s longstanding financial challenges. 
    • “Officials attributed the loss to a $634 million increase to workers’ compensation, among other spending hikes, paired with a $264 million reduction in operating revenue. In comparison, USPS saw a net income of $144 million during the first quarter of fiscal 2025. 
    • “USPS, however, experienced a net loss of $9 billion in fiscal 2025, and officials have projected that the postal agency will continue to operate in the red for fiscal 2026. 
    • “At a USPS Board of Governors meeting on Thursday, Postmaster General David Steiner and the board reiterated their argument that legislative and administrative reforms, such as raising the postal agency’s $15 billion statutory debt limit, are necessary to reverse these losses.”

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “With online health and wellness company Hims & Hers opening a new front in the GLP-1 compounding showdown Thursday, the United States’ top drug regulator has taken notice.
    • “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”
    • “Makary’s comments mark a clear and sharp rebuttal to Hims’ announcement earlier in the day that it had launched a compounded version of Novo Nordisk’s new Wegovy (semaglutide) pill for obesity, which starts at just $49 per month.”
  • and
    • “The FDA removed a prior “limitations of use” restriction it had placed on Gilead Sciences’ CAR-T Yescarta, allowing it to be used in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
    • “Yescarta is approved for R/R large B-cell lymphoma, but previously wasn’t permitted to treat those with the rare, fast-growing PCNSL subtype. Prognoses related to this disease, which originates in the brain, spinal cord, eye, or cerebrospinal fluid, are typically poor, with a five-year survival rate of about 30%. The cancer type has no standard-of-care treatment options and an estimated 1,500 cases are diagnosed annually in the U.S.
    • “Dana-Farber Cancer Institute ran a phase 1 study to evaluate the safety of Yescarta in patients with PCNSL, as those with the disease had previously been excluded from the clinical trials supporting Yescarta’s initial approval, global head of development at Gilead’s Kite unit, Gallia Levy, M.D., Ph.D. explained in a company release.” 
  • MedTech Dive relates,
    • “Johnson & Johnson is recalling certain Cerepak detachable coil systems due to a higher-than-expected failure to detach rate that has been associated with four serious injuries and one death. The events were reported as of Oct. 14.
    • “The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays or the need for additional surgical intervention, according to the Food and Drug Administration, which posted the recall on Thursday.
    • “J&J issued a letter to customers on Oct. 2 recommending they remove certain Cerepak products from where they are used or sold.”
  • Cardiovascular Business tells us,
    • “Zydus Pharmaceuticals, a New Jersey-based distributor of generic drugs, has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. The prescription-strength capsules were manufactured by Softgel Healthcare in India and are sold in the United States as a more affordable option to name-brand treatment options.
    • “Icosapent ethyl is primarily used to help treat patients with high triglyceride levels in their blood. Taken together with a statin, it can also help significantly reduce the risk of heart attack, stroke or other cardiac complications in certain patient populations.
    • “Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” according to the Food and Drug Administration (FDA).”

From the judicial front,

  • Fierce Healthcare reports,
    • “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 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 Wall Street Journal relates,
    • “Luigi Mangione will face murder and weapons charges in a Manhattan court in June for the killing of UnitedHealthcare CEO Brian Thompson, three months before jury selection in his federal trial for crimes related to the same killing.
    • “New York state court Judge Gregory Carro set a June 8 trial date during a snap hearing Friday, prompting an outburst from Mangione, who claimed he was being denied double-jeopardy protections.” * * *
    • “The Manhattan district attorney’s office argued the state case should go first because the killing occurred in Manhattan and local prosecutors—working with many NYPD detectives—led the investigation that resulted in Mangione’s arrest.
    • “The State has an overriding interest in trying this defendant for the cold-blooded execution of Brian Thompson on December 4, 2024. It resulted in the tragic death of a guest to our city on our streets,” Assistant District Attorney Joel Seidemann said in a letter to the judge.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends. Emergency department visits are stable and highest among children 5-17 years. Hospitalizations trends continue to decrease overall and are highest among those 65 years and older. RSV activity is elevated in many areas of the country. Emergency department visits for RSV are highest among infants under 1 year and children 1-4 years old. RSV hospitalizations are highest among infants less than 1 year old.
    • “COVID-19
      • COVID-19 activity is elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally with most areas of the country reporting stable or decreasing trends; however, activity continues to increase in the Pacific Northwest.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • RSV activity is elevated in many areas of the country, including emergency department visits among infants under 1 year and children 1-4 years old. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The University of Minnesota CIDRAP adds,
    • “The effectiveness of this season’s flu vaccine in Canada is 40% against medically attended infection with influenza A(H3N2) viruses, 37% against newly emerged and predominant subclade K of the H3N2 strain, and 31% against the H1N1 influenza A strain, an interim analysis estimates.
    • “Researchers from the Canadian Sentinel Practitioner Surveillance Network (SPSN) conducted the test-negative study, which evaluated samples from patients aged one year or older who had acute respiratory illness. Community-based sentinel health care providers in Alberta, British Columbia, Ontario, and Quebec collected the specimens from October 26, 2025, to January 10, 2026, and the findings were published yesterday in Eurosurveillance.”
  • The AP reports,
    • “During the early years of the COVID-19 pandemic, experts worried that disruptions to cancer diagnosis and treatment would cost lives. A new study suggests they were right.
    • “The federally funded study published Thursday by the medical journal JAMA Oncology is being called the first to assess the effects of pandemic-related disruptions on the short-term survival of cancer patients.
    • “Researchers found that people diagnosed with cancer in 2020 and 2021 had worse short-term survival than those diagnosed between 2015 and 2019. That was true across a range of cancers, and whether they were diagnosed at a late or early stage.
    • “Of course, COVID-19 itself was especially dangerous to patients already weakened by cancer, but the researchers worked to filter out deaths mainly attributed to the coronavirus, so they could see if other factors played a role.”
  • Healio informs us,
    • “As the number of home hazards increased, so did the effect of visual function on the odds of falling.
    • “Home safety evaluations and environmental adaptations could be helpful for adults with low vision.”
  • and
    • “Use of SGLT2 inhibitors was associated with lower 5-year risk for chronic kidney disease and AKI compared with GLP-1 receptor agonists for adults with type 2 diabetes, according to data published in JAMA Internal Medicine.”
  • Radiology Business lets us know;
    • “New research suggests that photon-counting computed tomography scans outshine conventional contrasted chest CT for follow-up imaging of lung cancer. 
    • “Patients who have been diagnosed with the disease require routine imaging to monitor treatment effectiveness and ensure their cancer has not progressed or recurred. This is typically done via standard contrast-enhanced CT scans. Though effective, the standard of care comes with caveats, including increased exposure to both radiation and contrast media. What’s more, image quality can vary based on patient size, which can negatively affect lesion detection and characterization. 
    • “Experts believe that emerging photon-counting technology can help address these shortcomings. Published in RSNA’s flagship journal, Radiology, a new paper details numerous benefits photon-counting CT scans have over conventional CTs, including reduced radiation exposure and enhanced lesion visualization. Experts involved in the study went as far as to suggest that the advanced technology could replace conventional CTs in certain settings soon.”
  • Genetic Engineering and Biotechnology News observes,
    • “If you zoomed in far enough on a new experimental HIV vaccine, you wouldn’t see the usual protein shell that most vaccines rely on. Instead, you’d find tiny geometric structures folded from strands of DNA—molecular origami designed not to be noticed at all. This “invisible” scaffold may be the key to awakening some of the rarest and most sought‑after cells in immunology: the B cells capable of maturing into broadly neutralizing antibody producers.
    • “Many next‑generation vaccines use virus‑like particles (VLPs)—nanostructures that mimic the outer shape of a virus but contain no genetic material. By displaying many copies of a viral antigen on their surface, VLPs can activate B cells far more effectively than free‑floating proteins. The paper is titled “DNA origami vaccines program antigen-focused germinal centers,” and was published recently in Science. 

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Centene is “laser-focused” on improving the performance of its Medicaid business following a difficult 2025.
    • “CEO Sarah London told investors Friday morning on the company’s earnings call that the team made headway in this effort in later part of 2025, with it’s Q4 medical loss ratio of 93% on par with expectations set for analysts in October and showing notable improvement from the second quarter of 2025.
    • “She said that utilization trend patterns seen in the third quarter largely carried into Q4, with behavioral health as the largest driver. Home health services and high-cost pharmaceuticals were also key factors in cost and utilization trends seen in the back half of the year, she said.
    • “And while a spike in flu and other respiratory illnesses generated headlines late in the year, London said that utilization patterns in its Medicaid population were on par with expectations.
    • “As an organization, we have been laser-focused on restoring our Medicaid business to sustainable profitability while maintaining our focus on quality outcomes for our members and the communities we serve,” London said.”
  • and
    • “Molina Healthcare’s share price plunged on Friday as it posted a $160 million loss in the fourth quarter as well as guidance for 2026 that fell short of analysts’ expectations.
    • “Shares in the company were down by about 28% at 11:30 a.m. ET, with its stock tumbling out of the gate at market open on Friday. By comparison, Molina earned $251 million in profit for the fourth quarter of 2024.
    • “For the full year, Molina has posted $472 million in profit, down from $1.2 billion in 2024.
    • “In the earnings report, Molina revealed that it will exit the Part D space in the 2027 plan year due to financial pressure, including Medicare Advantage prescription drug (MAPD) plans. The company will focus on its existing dual-eligible business in Medicare, according to the announcement.”
  • Healthcare Dive relates
    • “Primary care physicians spend a significant amount of time on work in their electronic health records, even when they decrease the number of appointments they schedule with patients, according to new research published in Health Affairs.
    • “Physicians who cut back appointments saw their visit volume decline by 32.6% compared with other doctors. But their EHR time fell by just 21.2% — meaning the number of minutes spent in their records systems actually increased per visit by more than 20%, according to the study. 
    • ‘Primary care physicians need to handle a lot of tasks outside appointments, like responding to patient messages, researchers wrote. So reducing visits doesn’t necessarily eliminate a host of EHR tasks — though it does have repercussions for physicians’ pay and patients’ access to care, they noted.” 
  • and
    • “Epic rolled out an artificial intelligence tool this week that drafts clinical notes, setting up the nation’s largest electronic health record vendor as a major competitor in the ambient scribe market. 
    • “AI Charting, part of Epic’s AI tool called Art geared toward clinicians, listens during patients’ appointments with providers and can suggest orders based on the conversation. The product also allows clinicians to personalize the note’s structure using voice commands, like asking the tool to format current conditions as a bulleted list, according to a press release. 
    • “Epic plans to expand beyond documentation to make the tool “an active assistant in the room,” Corey Miller, Epic’s vice president of research and development, said via email. “This is really just the start for Art,” he said.”
  • Fierce Healthcare adds,
    • “Infinitus has launched a new suite of agentic artificial intelligence tools for healthcare payers that aim to improve member engagement through personalized communications.
    • “Infinitus is an AI company that helps call centers better handle inbound call volumes. For payer organizations, pressured to control costs as call volumes rise and ratings of members demand a modern consumer experience, AI is positioned to solve both issues. 
    • “With the Agentic AI Member Services Suite, health plan members have 24/7 access to an AI agent that can answer simple administrative questions, onboard members, triage questions and navigate care. Through messaging and calling capabilities, Inifinitus’ AI agents can proactively reach out to patients and scale member services without adding team members.”
  • and
    • “Aetna is continuing to build out its digital member experience with the launch of a new onboarding program designed to ease the process.
    • “The insurer said Thursday that the platform will be available to 4 million new members during the welcome period for their enrollment. The program leads on Rich Communication Services, or RCS, to support navigation and connect members with key information and resources they may need after enrolling in a new plan through text messaging.
    • “Nathan Frank, senior vice president and chief digital and technology officer for Aetna, told Fierce Healthcare that building trust with the member requires an end-to-end experience, and tech like the new onboarding program can play a key role in that effort.
    • “Onboarding isn’t just about administration and signing people up and making sure that you have the right information,” he said. “It’s the moment when members decide whether their health plan feels simple, or is it overwhelming?”