Weekend Update

Generative AI

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • These two Congressional hearings scheduled for March 18, 2026, caught the FEHBlog’s eye.
    • House Energy and Commerce Subcommittee on Health
    • 10:15 AM Local Time | 2123 Rayburn House Office Building, Washington, D.C.
    • Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape
    • Meeting Details, and
    • House Ways and Means Subcommittee on Health
    • 2:00 PM Local Time | 1100 Longworth House Office Bldg, Washington, D.C.
    • Improving Kidney Health Through Better Prevention and Innovative Treatment
    • Meeting Details

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “CDC scientists estimate there have been at least 27 million illnesses, 350,000 hospitalizations, and 22,000 deaths from flu so far this season. At the same point last year, the estimates were at least 40 million illnesses, 520,000 hospitalizations, but about the same number of deaths.
    • “Flu infections surged in late December and were especially intense in some parts of the country. New York City health officials called it the most intense season in 20 years.
    • “At least 101 children have died so far this season, down from the unusually bad season in 2024-2025 that set a record for the most child flu deathsopens in a new tab or window this century with more than 200. For those whose vaccination status is known this season, about 85% were not fully vaccinated against the flu.
    • “The flu vaccine may not protect everyone from getting sick, but it can prevent people from becoming severely ill and dying. That’s why getting a flu shot remains worthwhile, Schaffner said.
    • “Relatively low flu vaccination rates did not help this season, but experts also blamed a new flu strain that was not well matched to the vaccine for causing most infections.
    • “The new strain, A H3N2 subclade K, seemed to spread more easily — though it did not necessarily cause more severe illness.”
  • and
    • “Nearly 4% of people in the US initially diagnosed with type 2 diabetes (T2D) between July 2016 and October 2024 were later reclassified as having type 1 diabetes (T1D), a new analysis of data from the TriNetX database showed. 
    • “We still have this problem of identifying people with type 1 diabetes,” said endocrinologist Jeremy H. Pettus, MD, associate professor of medicine at the University of California, San Diego (UCSD), who presented the study findings at the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2026.
    • “We really have to think about this and move towards” using autoantibodies more often, he added. 
    • “Individuals who had been initially misdiagnosed tended to be younger than those who retained the T2D diagnosis, but there was no difference when stratified by BMI, Pettus reported. The reclassified group also had higher healthcare utilization.” 
  • Cardiovascular Business tells us,
    • “A new study of U.S. healthcare data found that more than 1 in 3 working-age adults with cardiovascular disease are spending more than 10% of their income on healthcare expenses. In addition, 1 in 10 are facing catastrophic healthcare expenditures. 
    • “The data was published JACC, the flagship journal of the American College of Cardiology.
    • According to the study’s authors, their analysis calls attention to the impact of the rapidly rising costs of cardiac care and the need for policy changes reducing financial barriers.
    • “Given the confluence of rising costs and worsening cardiovascular health among working-age adults, reducing financial barriers to care must be central to national efforts to improve cardiovascular outcomes in this population,” wrote lead author Smaraki Dash, MD, MPH, with the Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center in Boston, and colleagues.
    • “Dash et al. said policies needs to be changed to ensure patients can afford consistent access to preventive, diagnostic and therapeutic cardiovascular services and that they do not forego care. Despite substantial national spending, cardiovascular risk factor control and outcomes have worsened in adults ages 25-64 since 2010. Financial barriers are likely driving these trends, especially among privately insured adults, who face higher out-of-pocket costs than those with public insurance.”
  • The Wall Street Journal relates,
    • “Pain lasts longer for women than it does for men—partly because of differences in testosterone levels, a recent study suggests.
    • “Research has long indicated that men generally recover faster from pain and are less likely than women to develop chronic pain. Now scientists have a better idea why. 
    • “When you get injured, your immune system sends certain white blood cells to calm pain-sensing neurons and inflammation. In men, those white blood cells are more likely to produce a pain-resolving molecule that can quickly quell the ache, according to a recent study in the journal Science Immunology.
    • “The testosterone hormone is probably what drives the increased production of that pain-resolving molecule, known as interleukin-10, the researchers found.
    • “It’s not because women are too emotional or too soft, and the pain is just in their head,” said Geoffroy Laumet, a neuroimmunologist at Michigan State University and study co-author.”
  • and
    • “Legalization of recreational marijuana by many states has made it easier for teens to get access to highly potent and convenient forms of the drug, creating new hazards for teen health. 
    • “New research shows that using it as little as once a month or less as a teenager is linked to an increased risk of developing psychiatric disorders and doing poorly in school.
    • “Of the more than 460,000 teens ages 13 to 17 who researchers asked about cannabis use, the ones who said they had used it in the prior year had a higher likelihood of developing depression and anxiety disorders, according to a study published last month in the journal JAMA Health Forum.
    • “We can’t find a level of cannabis use in a teenager that we don’t see a negative effect,” said Dr. Ryan Sultan, assistant professor of clinical psychiatry at Columbia University Irving Medical Center who treats patients with cannabis use disorder.
    • “The new concerns about the impact of marijuana on kids’ health is one of the factors driving a crackdown on the use of the drug at schools.”

From the U.S. healthcare business front,

  • Per a Quest Diagnostics news release,
    • “Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, today announced that its board of directors has elected Timothy (Tim) Wentworth, a highly seasoned business leader, to serve as a director. Including Mr. Wentworth, the company’s board has eleven members.” * * *
    • “Mr. Wentworth, 65, was most recently chief executive officer (CEO) of Walgreens Boots Alliance, where he helped restructure the company for its sale to Sycamore Partners in mid-2025. Prior to that, he was founding CEO of Evernorth Health Services,the health services organization of The Cigna Group that partners with health plans, employers and government organizations to deliver pharmacy, care, and benefit solutions.”
  • Modern Healthcare reports,
    • Healthcare revenue rose faster than all other services categories in 2025, as increased prices for care and growing demand from an aging population affect the industry. 
    • Revenue tied to the delivery of healthcare services increased 8.6% year-over-year, compared with a 6.1% combined increase for all other categories in the services sector, according to a Modern Healthcare analysis of Census Bureau data. Other industries in the services category include finance, transportation, real estate, entertainment and education.
    • “Despite the gain, the sector’s momentum is slowing. Healthcare revenue rose 10.1% in 2024 and 11.2% in 2023, according to the analysis.
    • “Estimates are based on the Census Bureau’s quarterly surveys for revenue and expenses at companies in select industries. The fourth-quarter survey released Thursday draws data from about 19,500 firms across all industries.” 
  • Medcity News points out,
    • “The Aging Crisis Is Here, and Technology Is No Longer Optional.
    • “We need to pivot from a deficiency to an abundance model – from over-focusing on what an individual cannot do, to making the most of the physical and mental resources at hand to maximize independence, dignity, and quality of life. This includes rethinking physical environments and thoughtfully embedding technology to support capability rather than limitation as we adapt to a new reality.”
  • HR Dive adds,
    • “20%
      • “The percentage of employees who said they view AI as a co-worker, per survey results published by Slingshot and parent company Infragistics.
    • “26%
      • “The share of workers who said they are experimenting with AI to improve their work, according to an analysis published by Gartner.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iran War front,

  • Dark Reading reports,
    • “Iranian state intelligence has been utilizing the cybercriminal underground to upgrade and provide cover for its offensive cyber activity.
    • “Iran’s Ministry of Intelligence and Security (MOIS) has long used hacktivism as a cover when it carries out cyberattacks. On March 11, for example, a wiper attack struck the Fortune 500 medical technology company Stryker. It was claimed by “Handala,” a group that positions itself as a pro-Palestine hacktivist operation, evidently itching to contribute to the ongoing US-Iran war. In fact, it’s a front for Void Manticore, an advanced persistent threat (APT) run out of Iran’s MOIS.
    • “This isn’t a new strategy. What is new, according to recent research from Check Point, is that MOIS hackers have been working with the real cybercriminals they’re pretending to be. Void Manticore, for example, has made the commercial infostealer Rhadamanthys a core element of its attack chains. Other MOIS entities have been linked to cybercrime clusters, even collaborating with ransomware-as-a-service (RaaS) operations.
    • Organizations need to be aware of this, says Sergey Shykevich, threat intelligence group manager at Check Point, “because there can be a case where a SOC or CISO will see something in their network that they associate with cybercrime activity [and label it] of low risk. And in reality, it will be an Iranian threat actor who will be able to execute destructive activities.”
  • The Wall Street Journal tells us on March 12,
    • “Stryker said a cyberattack related to the Iranian conflict is still disrupting its operations, including order processing, manufacturing and shipping.
    • “Stryker experienced a global disruption to its Microsoft systems following a cyberattack Wednesday, which resulted in the company asking 56,000 employees to disconnect from all networks and avoid turning on company devices.
    • “The hackers behind the attack said they were retaliating on behalf of Iran, The Wall Street Journal reported Wednesday.
    • “On Thursday, Stryker said operations were still disrupted, but it doesn’t believe its patient-related services or connected products have been impacted.”
  • Security Week adds,
    • “Stryker is a Fortune 500 company that specializes in the manufacturing of surgical equipment, orthopedic implants, and neurotechnology. Headquartered in Michigan, the company employs approximately 56,000 people and reported over $25 billion in revenue for 2025. Its critical role in the healthcare supply chain makes it an essential partner for hospitals worldwide.”
    • “The Iran-linked hacker group named Handala has taken credit for the attack, claiming to have struck an “unprecedented blow” to the company.”
  • and
    • Like other ideologically motivated hackers, profit is not Handala’s goal, according to Ismael Valenzuela, vice president of threat intelligence at the cybersecurity company Arctic Wolf.
    • “What distinguishes this group is its clear focus on data destruction rather than financial extortion,” he said in an email.
  • Cybersecurity Dive points out,
    • “Stryker said the cyberattack that hit the company this week has disrupted its manufacturing and shipping operations.
    • “The medtech company released the information Thursday night [March 12] in a statement posted to its website. Stryker did not detail the attack’s impact on its systems, but wrote in the statement that the incident has caused disruptions to order processing, manufacturing and shipping.
    • “However, we are working diligently to restore our systems and above all, we are committed to ensuring our customers can continue to deliver seamless patient care,” the company said.
    • Stryker maintained that the incident is contained to its internal Microsoft environment, and there is no malware or ransomware detected.”

From the cybersecurity policy and law enforcement front,

  • Federal News Network reports,
    • “U.S. Cyber Command and the National Security Agency have a new permanent leader. The Senate has confirmed Gen. Joshua Rudd to serve as the next director of CYBERCOM and NSA. The two organizations have been without a permanent leader since April, when President Donald Trump fired Gen. Timothy Haugh from the role. Some Democratic lawmakers objected to Rudd’s nomination, citing his lack of cyber experience needed to immediately step into the dual leadership position. Sen. Ron Wyden (D-Ore.) said that when it comes to U.S. cybersecurity, “there is simply no time for on-the-job learning.” It’s not clear when Rudd will be sworn in.”
  • and
    • “The Cybersecurity and Infrastructure Security Agency (CISA) is postponing meetings with industry on a forthcoming cyber incident reporting rule due to the ongoing Department of Homeland Security shutdown.
    • “The shutdown is also “likely” to delay the final Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) rule, CISA confirmed today [March 9].
    • “In a notice posted to its website, CISA said it won’t be able to hold planned town halls on CIRCIA due to the lapse in appropriations. The town halls were scheduled for today, March 9, through early April.”
  • Cyberscoop relates,
    • “The Trump administration is plotting an interagency body to confront malign hackers, pilot programs to secure critical infrastructure across states and other steps tied to its freshly-released cyber strategy, National Cyber Director Sean Cairncross said Monday.
    • “The “interagency cell” will bring together agencies like the Justice Department, the Department of State, the FBI and the Pentagon, which will make it clear that going on cyber offense isn’t just about attacking enemies in cyberspace, Cairncross said.
    • “Sure, that’s part of it, but that’s not all of it,” he said at an event hosted by USTelecom. It will include diplomatic efforts, arrests and more, he said. “As President Trump has made clear, he expects results, and he’s empowered the team under him to go get them.
    • “A series of pilot programs will be catered to specific critical infrastructure industries in specific states, such as water in Texas and beef in South Dakota, Cairncross said. Different sectors operate at more or less mature levels, he said.”
  • Cybersecurity Dive tells us,
    • “Inconsistent definitions, overly burdensome information demands and duplicative requirements are some of the problems that U.S. businesses face in dealing with cybersecurity regulations, according to a recent Government Accountability Office report.
    • “Critical infrastructure organizations want federal agencies to work together to streamline their rules, according to the March 5 summary of a GAO panel discussion with infrastructure representatives.
    • “Businesses recommended several possible solutions to the regulatory sprawl, including agencies converging on common definitions of key terms.”
  • and
  • Cyberscoop informs us,
    • “41-year-old South Florida man is accused of conducting at least 10 ransomware attacks and helping accomplices extort a combined $75.25 million in ransom payments while he was working as a ransomware negotiator for DigitalMint. 
    • “Five of Angelo John Martino III’s alleged victims hired DigitalMint, which assigned Martino to conduct ransomware negotiations on their clients’ behalf — putting him in a position to play both sides, as the criminal responsible for the attack and the lead negotiator for his alleged victims, according to federal court records unsealed Wednesday.
    • “Martino allegedly obtained an affiliate account on ALPHV, also known as BlackCat, and conspired with other former cybersecurity professionals to break into victims’ networks, steal and encrypt data, and extort companies for ransoms over a six-month period in 2023.
    • “Martino was an unnamed co-conspirator in an indictment filed in November 2025 against Kevin Tyler Martin, another former ransomware negotiator at DigitalMint, and Ryan Clifford Goldberg, a former manager of incident response at Sygnia. Goldberg and Martin pleaded guilty in December to participating in a series of ransomware attacks and are scheduled for sentencing April 30.”
  • and
    • “Authorities from multiple countries dismantled SocksEscort, a residential proxy network cybercriminals used to commit large-scale fraud, claiming access to about 369,000 IP addresses since 2020, the Justice Department said Thursday.
    • “Europol, which aided the investigation alongside various law enforcement agencies, Lumen’s Black Lotus Labs and the Shadowserver Foundation, said the malicious proxy service compromised routers and IoT devices in 163 countries. Officials said the proxy network’s payment platform received about $5.8 million from its customers.
    • “The globally coordinated action, dubbed Operation Lightning, took down and seized 34 domains and 23 servers in seven countries. U.S. officials froze a combined $3.5 million in cryptocurrency allegedly linked to the botnet that was created from infected devices.
    • “Cybercrime thrives on anonymity,” Catherine De Bolle, executive director at Europol, said in a statement. “Proxy services like SocksEscort provide criminals with the digital cover they need to launch attacks, distribute illegal content and evade detection.”

From the cybersecurity breaches and vulnerabilities front,

  • MedTech Dive reports,
    • “Intuitive Surgical was hit by a cybersecurity phishing incident that compromised customer and employee data.
    • “Information was obtained from an employee’s compromised access into Intutive’s internal business administrative network, the surgical robotics firm said in a statement posted to its website. An unauthorized third party accessed information including customer business and contact information, as well employee and corporate data.
    • “The statement was posted on Thursday [March 12], an Intuitive spokesperson said in an email to MedTech Dive.
    • “When the incident was discovered, the company activated its incident response protocols and secured all affected applications.”
  • Bleeping Security adds,
    • “Starbucks has disclosed a data breach affecting hundreds of employees after threat actors gained access to their Starbucks Partner Central accounts.
    • “As the world’s largest coffeehouse chain, Starbucks has over 380,000 employees (also known as partners) and operates nearly 41,000 locations across 88 countries.
    • “In data breach notification letters filed with Maine’s Attorney General and sent to affected employees on Tuesday, the company says that it discovered the incident on February 6.
  • Cyberscoop relates,
    • “Threat hunters and a collection of unconfirmed victims are responding to a series of attacks targeting Salesforce customers, which the vendor disclosed in a security advisory Saturday [March 7]. 
    • “Salesforce is actively monitoring threat activity targeting public-facing Experience Cloud sites, including attempts to take advantage of overly permissive guest user configurations,” the company said in the alert.
    • “The campaign marks the third widespread attack spree targeting Salesforce customers in about six months. 
    • “The number of victims ensnared by the latest attacks is unverified, but ShinyHunters, the threat group asserting responsibility for the attacks, claims about 100 companies have already been impacted.”
  • and
    • “A maximum-severity vulnerability in pac4j, an open-source library integrated into hundreds of software packages and repositories, poses a significant security threat, but has thus far received scant attention.
    • “The defect in the Java security engine, which handles authentication across multiple frameworks, has not been exploited in the wild since code review firm CodeAnt AI published a proof-of-concept exploit last week. The company discovered the vulnerability and privately reported it to pac4j’s maintainer, which disclosed the defectand released patches for affected versions of the library within two days.
    • “Some researchers told CyberScoop they are concerned about the vulnerability — CVE-2026-29000 — because it affects a widely deployed Java security engine that attackers can exploit with relative ease.
    • “A threat actor only needs to access a server’s public RSA key to attempt exploitation,” researchers at Arctic Wolf Labs said in an email. 
  • Cybersecurity Dive points out,
    • “Prolific cybercrime gangs have begun using AI to help them generate malware, signaling a “fundamental shift of dynamics” in the threat environment, IBM’s X-Force threat intelligence team said in a report published on Thursday [March 12].
    • “The malware, which IBM called Slopoly, is “relatively unspectacular” but nonetheless a harbinger of a coming future in which automated code development can rapidly accelerate the hacking life cycle, according to the report.
    • “IBM linked the malware to Hive0163, a group of hackers who have used the Interlock ransomware in several recent major attacks.”
  • Dark Reading notes,
    • “Exploitation of user-managed cloud software has overtaken credential abuse as the method by which most attackers gain initial access to cloud resources.
    • “In its semi-annual “Cloud Threat Horizons Report,” Google found attacks on user-managed software applications — such as the the React2Shell attack targeting a flaw in React Server Components — bested software vulnerabilities to become the most frequently exploited vector for initial access. Overall, “software-based entry,” which includes exploiting software vulnerabilities such as remote code execution (RCE) flaws, accounted for about 44% of all initial-access activity in Google Cloud, the company stated in the report.
    • “The shift is likely due to the company’s focus on secure-by-default strategies and cloud users taking measures to shrink the stolen credentials and misconfiguration attack surfaces, says Crystal Lister, a security adviser in the Office of the CISO at Google Cloud.
    • “As defenders address some of the initial, enduring cloud hygiene issues, attackers are being forced to focus on more sophisticated, automated paths,” she says. “It isn’t necessarily that companies are cutting corners, but rather that the defensive perimeter has moved. Attackers are now targeting the third-party user-managed software running on top of the cloud rather than the cloud infrastructure itself.”

From the ransomware front,

  • Spiceworks explains “why encrypted backups may fail in an AI-driven ransomware era.” Check it out.
  • Healthcare IT News tells us how to stop ransomware disruption with better planning.
    • “Lessons from a LockBit ransomware attack can keep healthcare organizations running when faced with a cyberattack, said Zachary Lewis, CIO and CISO at University of Health Sciences and Pharmacy, in his HIMSS26 Cyber Forum keynote.”
  • Two former federal government cybersecurity officials, writing in Cyberscoop, point out,
    • “We’ve seen ransomware cost American lives. Here’s what it will actually take to stop it.
    • “Hackers have cut their attack timelines from weeks to hours while the government spreads resources too thin. We need to stop pretending we can protect everything and start focusing on what would hurt us most.”

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “Google on Wednesday said it completed a $32 billion agreement to buy Wiz, a leading cloud and AI security platform, marking one of the largest-ever acquisitions in the cybersecurity market. 
    • “The deal will allow Google to provide a comprehensive security offering to both government and enterprise customers operating across multicloud environments. 
    • “Wiz works across the leading cloud providers, including Amazon Web Services, Microsoft Azure and Oracle Cloud. 
    • “The platform will continue to operate under its own brand name, while providing a broad range of services through its integration with Google Cloud.”
  • Security Week relates,
    • “OpenAI announced this week that it’s in the process of acquiring AI security company Promptfoo.
    • “Financial terms of the acquisition have not been disclosed, but Promptfoo has raised more than $23 million and was reportedly valued at $86 million (based on PitchBook data) following an $18.4 million Series A funding round in July 2025.
    • “Promptfoo has developed a security and evaluation platform designed to systematically test LLMs and AI agents. * * *
    • “Once it completes the acquisition, OpenAI plans to integrate Promptfoo’s capabilities into its Frontier platform, which enterprises use to build and operate AI coworkers.  
    • “Promptfoo brings deep engineering expertise in evaluating, securing, and testing AI systems at enterprise scale. Their work helps businesses deploy secure and reliable AI applications, and we’re excited to bring these capabilities directly into Frontier,” said Srinivas Narayanan, CTO of B2B Applications at OpenAI.”
  • Cyberscoop tells us,
    • “Artificial intelligence may be enhancing cyber threats, but the defensive approach to those AI-amplified attacks remains the same, a top FBI official said Tuesday.
    • “We have seen actors both criminal and nation-state, they’re absolutely using AI to their advantage,” said Jason Bilnoski, deputy assistant director at the FBI’s cyber division. “But the way attacks unfold have not changed. Cyberattacks still follow basic steps. It just becomes an incredible speed now.”
    • “The best way to deal with those attacks is to implement all the traditional defenses, like those the FBI has been emphasizing as part of its Operation Winter SHIELD media campaign, he said.
    • “Don’t worry about the speed and capability” of AI attacks, Biloski said at a Billington Cybersecurity conference. “If you’re focused on the basics, it’ll help prevent the actual intrusion from occurring.
    • “It’s a message that the acting director of the Cybersecurity and Infrastructure Security Agency, Nick Andersen, also shared at the conference. Sophisticated attackers are out there, he said, but the agency’s recent binding operational directive for federal agencies to get rid of unsupported edge devices was a way of shoring up basic vulnerabilities.”
  • Dark Reading informs us,
  • Tech Target points out how to choose the best mobile hotspot for remote work.
    • “Organizations that support remote work should understand how personal hotspots and dedicated hotspot devices differ. Compare these mobile hotspot options.”
  • Here’s a link to Dark Reading’s CISO Corner.

Friday report

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

From Washington, DC,

  • STAT News informs us,
    • “White House officials are steering the Trump administration away from vaccine reform, fearing the political consequences of emphasizing a relatively unpopular issue in a key election year.
    • “But the Make America Healthy Again movement, led by Robert F. Kennedy Jr. — a health secretary with a history of anti-vaccine activism — isn’t going along without a fight.”
  • FedWeek reports,
    • “The House government operations subcommittee has scheduled hearings next week on the state of USPS finances and operations, including, in the words of the announcement, “whether USPS is reliable enough for Congress to allow it to borrow more money from the Department of the Treasury.”
    • “USPS is rapidly losing money and becoming more unreliable each year and is dire need of a course-correction. While some progress has been made to improve USPS operations, there is still much more work to be done to reform the agency and make up for the billions it has already lost,” the subcommittee said in scheduling Postmaster General David Steiner and the GAO as witnesses.”
    • The hearing will be held next Tuesday March 17 at 2 pm ET.
  • Federal News Network relates,
    • As the Trump administration’s Schedule Policy/Career nears finalization, Office of Personnel Management Director Scott Kupor reaffirmed his view that the pending personnel change is centered on “accountability,” rather than politicization.
    • The OPM director pushed back against criticisms from the federal community, after many warned of a return to a patronage system in the career civil service if the new federal employment classification is finalized.
    • “I think most federal employees know this — and certainly all the ones I’ve encountered have had no problem with this — your job is ultimately to effect lawful actions that the president determines are the appropriate objectives for the organization,” Kupor said during a March 5 event hosted by Federal News Network. “That’s what this does — basically codify what essentially has always been the practice of the executive branch.”
    • Tens of thousands of federal employees are on track to soon be converted to the new Schedule Policy/Career category, leaving them with limited appeal rights and making it easier for agencies to fire them.
    • FEHBlog note — This rule became effective on March 9, 2026.
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS), through its Office on Women’s Health (OWH), today announced a formal Memorandum of Understanding (MOU) with the American Urological Association, the American Urological Education and Research, and the Urology Care Foundation (together, the AUA) to promote the appropriate and evidence-based use of local estrogen therapy in postmenopausal women, particularly those experiencing genitourinary syndrome of menopause (GSM) and recurrent urinary tract infections (UTIs).
    • “The collaboration reflects a unified commitment by both institutions to improving women’s health, preventing disease, and enhancing quality of life through safe and effective therapies. Together, HHS and the AUA will exchange information, develop educational resources, and work collaboratively to reach health care providers and women across the country.
    • “This collaboration represents an important step forward in addressing a significant and often undertreated women’s health concern,” said Dorothy A. Fink, M.D., Principal Deputy Assistant Secretary for Health and Director of the HHS Office on Women’s Health. “Many postmenopausal women are not aware that local estrogen therapy is a safe and effective treatment for GSM and recurrent UTIs. By joining forces with the AUA, we can ensure that clinicians and patients alike have access to clear, evidence-based guidance.”
  • Kaiser Family Foundation (KFF) tells us,
    • “A new KFF analysis examines Medicare Advantage coverage options in 2026 for the 2.6 million enrollees whose Medicare Advantage plan with prescription drug coverage was terminated at the end of 2025. Plan termination affected 13% of all enrollees in such plans in 2025, more than double the 6% affected the year before.
    • “Medicare Advantage insurers have warned that recent and prospective changes to the Medicare Advantage payment system are driving plan terminations and reductions in benefits. The analysis finds, however, that almost all of the enrollees whose plans were terminated have at least one Medicare Advantage plan with drug coverage (MA-PD) available in 2026, and on average they have more than two dozen plan options to choose from in their area. Most beneficiaries affected by the termination of a plan that had a zero-premium MA-PD option in 2025 also had a zero-premium MA-PD option for 2026.
    • “Just 1.1% of those who were in terminated plans nationwide, or fewer than 30,000 people, have no option for a Medicare Advantage plan with drug coverage for 2026.”
  • KFF also updated its key facts about the CMS drug negotiation program.

From the Food and Drug Administration front,

  • The University of Minnesota’s CIDRAP tells us,
    • :British drugmaker GSK said today that the US Food and Drug Administration (FDA) has expanded the approved use of its respiratory syncytial virus (RSV) vaccine for younger adults at risk of complications from the virus.
    • “In a news release, the company said the FDA approved Arexvy for use in adults aged 18 to 49 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV. The vaccine was previously approved for all adults aged 60 and over and those aged 50 to 59 at increased risk of LRTD caused by RSV.”
  • BioPharma Dive informs us,
    • “For the first time, the Food and Drug Administration is allowing a certain kind of cell therapy for epilepsy to be tested in humans.
    • “The therapy, created by Shanghai-based Unixell Biotechnology, is designed to curb the excessive electrical activity that triggers seizures in epileptic patients. It uses donor-derived — or “allogeneic” — stem cells reprogrammed so that they ultimately produce the main chemical messenger, “GABA,” responsible for calming the brain and nervous system.” * * *
    • “Yet, Unixell will likely also face newer competition. Decades of research into ion channels — cellular tunnels that often play a role in epilepsy — has finally started to bear fruit.”
  • Cardiovascular Business notes,
    • “Vena Medical, a Canada-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its Vena MicroAngioscope System—advertised as the “world’s smallest camera”—to be used for intravascular imaging in the peripheral arteries.
    • “The device was designed to help care teams evaluate a patient’s peripheral vasculature without the use of X-ray fluoroscopy. It connects to standard endoscopy equipment and is used in tandem with a balloon distal access catheter to provide real-time color images. The balloon occludes the vessel temporarily and the segment is flushed with saline to enable the camera to directly image the interior of the vessel.
    • ‘In Canada, more than 100 patients have already been treated with the Vena MicroAngioscope System. With this FDA clearance in place, the company now plans to enter the hospitals and health systems in the United States.”
  • Per Fierce Pharma,
    • “The FDA has rejected Hyloris Pharmaceuticals antiviral valacyclovir, an oral suspension for infections caused by herpes simplex and varicella zoster viruses. 
    • “In a complete response letter (CRL), the FDA said it identified issues in an inspection of Hyloris’ third-party manufacturer. The U.S. regulator did not specify the problems in the CRL, explaining that they were itemized to a representative of the production facility.
    • “The CRL was not a surprise. In a release last month, Belgium-based Hyloris explained (PDF) that the FDA had assigned an official action indicated (OAI) classification to the Greek facility after an inspection.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
      • “Interim estimates for the 2025–26 seasonal influenza vaccine prove getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.”
  • The American Hospital Association News reported today,
    • “There have been 1,362 confirmed measles cases nationwide this year, according to the latest data published today by the Centers for Disease Control and Prevention. Of those, 94% are associated with outbreaks. South Carolina and Utah currently have the largest ongoing measles outbreaks in the country. The South Carolina outbreak, which began in October 2025, has slowed in recent weeks and is at 996 cases as of today. Utah’s outbreak, which began in June 2025, has risen to 405 cases as of March 10, marking an increase of 47 cases since last week.” 
  • The Wall Street Journal relates,
    • “Adults should be screened and treated for high cholesterol starting at age 30, if not sooner, according to new clinical guidelines, lowering the age by at least a decade at a time when heart attacks are becoming more common in younger adults. 
    • “The goal is to shift to a more proactive approach to head off problems in younger years, rather than starting lifestyle changes and medical treatment in middle age when a patient may already have damage in their arteries, said Dr. Roger Blumenthal, chair of the committee of cardiologists that wrote the new guidelines. 
    • “Growing research shows how much damage can be done when levels of LDL, or “bad,” cholesterol stay high in the blood for years, he said. At the same time, more medicineshave become available to lower cholesterol, along with screening tests and a new online tool that allows people 30 and older to calculate their risk of cardiovascular disease.
    • “We need to pay attention much earlier,” said Blumenthal, director of preventive cardiology at Johns Hopkins Medicine.  
    • “The guidelines, published Friday in two leading cardiology journals, were issued by 11 medical associations, including the American College of Cardiology and American Heart Association. These organizations set standards for medical professionals from family doctors to cardiologists.”
  • Per a National Institutes of Health news release,
    • “A team of researchers funded by the National Institutes of Health (NIH) have developed an artificial intelligence (AI) tool that provides decision support to clinicians by predicting if patients are at risk of intimate partner violence (IPV). Using data routinely collected during medical visits, the team trained a machine-learning model, a type of AI, that was highly accurate in detecting IPV among patients in a study. 
    • “IPV refers to abuse from current or former partners that results in serious effects such as potentially life-threatening injuries, chronic pain and mental health disorders. It affects millions of people in the United States — both men and women — at some point in their lives. However, many cases go undetected, because patients can be hesitant to disclose abusive relationships due to safety concerns, fear and stigma. 
    • “In their study, the research team led by researchers from Harvard Medical School, Boston, introduced three AI models for IPV detection in healthcare settings, comparing their performance in predicting it.  
    • “This clinical decision support tool could make a significant impact on prediction and prevention of intimate partner violence,” said Dr. Qi Duan, Ph.D., director of the Division of Health Informatics Technologies at NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). “Given the prevalence of cases, the tool could be a game-changing asset to public health.” 
  • Health Day informs us,
    • “People frequently switch between different weight-loss drugs, swapping Ozempic for Zepbound and vice versa within the first year of treatment, a new study reports.
    • “What’s more, those patients who do swap GLP-1 drugs are more likely to stick with the drugs, researchers reported March 10 in JAMA Network Open.
    • “Switching between GLP-1RA medications should be viewed as a normal part of long-term obesity care,” said senior researcher Sarah Messiah, a professor of epidemiology and pediatrics at UT Southwestern Medical Center in Dallas.
    • “Persistence should not be judged by staying on a single drug indefinitely, but by maintaining engagement in care and working with clinicians to find sustainable, effective treatment strategies over time,” she said in a news release.”
  • and
    • “Vitamin D3 supplementation does not change the four-week incidence of health care utilization or COVID-19-related outcomes among adults with newly diagnosed COVID-19 but may reduce the risk for long COVID, according to a study published online March 12 in the Journal of Nutrition.”
  • Per BioPharma Dive,
    • “Vima Therapeutics announced Wednesday it has raised $100 million in the hopes of bringing to market a new oral therapy that might help people with certain neurological disorders regain control of movement.
    • “The company was hatched by biotechnology investor Atlas Venture more than three years ago. It’s since advanced a combination drug called VIM0423 to the precipice of mid-stage studies in Parkinson’s disease and dystonia. Both trials are expected to read out in 2027.
    • “Vima estimates that about 160,000 people in the U.S. have isolated dystonia, a chronic and disabling neurological condition that causes involuntary muscle contractions that can worsen as a person moves. For a larger share, dystonia is a symptom of other brain diseases, among them Parkinson’s.”
  • Per Genetic Engineering and Biotechnology News,
    • “Lipid nanoparticles (LNPs) act as carriers for mRNA and CRISPR payloads across a wide range of therapeutic applications, from cancer to inflammatory and genetic diseases. The same delivery system used in COVID‑19 vaccines is now being adapted for other, more complex targets, but one challenge persists: LNPs transfer their cargo into cells far more readily in the lab than in the body. What makes in vivo delivery so much harder?
    • “A new study from Biohub may have uncovered a surprisingly simple way around this barrier. From Science Translational Medicine, in a paper titled “Amino acid supplementation enhances in vivoefficacy of lipid nanoparticle‑mediated mRNA delivery in preclinical models,” the team reports that co‑injecting three common amino acids with LNPs dramatically boosts both mRNA delivery and CRISPR gene editing efficiency.
    • “Gene editing and mRNA‑based therapies will play increasing roles in the medicine of the future, but they require LNPs to reach and enter cells,” said Shana O. Kelley, PhD, president of bioengineering at Biohub and head of Biohub Chicago, in a press release. “Any LNP formulation being developed today could potentially benefit from our approach.”
    • “Rather than redesigning the nanoparticles themselves—a major focus of the field—the researchers asked: Could the body’s own metabolic environment be making cells less receptive to LNP fusion?
    • “By asking why LNPs perform so differently in the physiological milieu of the body, we found a surprisingly simple answer that could make a wide range of mRNA and gene editing therapies substantially more effective,” said Daniel Zongjie Wang, PhD, who leads Biohub’s Spatiotemporal Omics Group.”

From the HIMSS Conference 2026 front,

  • While the conference ended yesterday, the FEHBlog ran across some interesting stories from the conference today.
  • Healthcare IT News tells us,
    • “Digital transformation demands accurate, trusted identity data
    • “Identity is part of foundational infrastructure and should be strengthened so digital transformation initiatives can truly deliver, says MDM tech exec Rachel Blum at HIMSS26.”
  • Healthcare Dive informs us,
    • “The CMS wants to deploy artificial intelligence tools to Medicare beneficiaries to help navigate their care, CMS officials said at the HIMSS conference Thursday. 
    • The agency is already using the technology to detect fraud. But the CMS also hopes to get the technology into patients’ hands, both to assist seniors and to hopefully bring down rising healthcare spending, which continues to outpace the rest of the economy. 
    • “The fundamental problem right now is that other sectors of the U.S. economy have advanced and been deflationary with their use of technology,” CMS Administrator Dr. Mehmet Oz said during a panel discussion. “Healthcare has remained inflationary.”
  • Beckers Hospital Review offers six notes from the conference.
  • Beckers Health IT adds,
    • “As healthcare AI moves beyond the pilot phase, health systems need to build the infrastructure to enable the technology for the long term, according to a recent panel discussion at New York City-based Columbia Business School.”

From the U.S. healthcare business front,

  • Kaufmann Hall reports,
    • The latest Vizient Research Institute study, The access imperative: Reimagining care delivery for a more complex patient population, concludes that the bulk of hospitalizations in the United States are due to chronic illness. Patients with chronic conditions generate roughly 10 times more inpatient admissions and emergency department visits and more than six times as many office visits compared with those without chronic care needs. On a per capita basis, they generate about 17 times more inpatient days. With more than 80% of hospitalizations involving Americans with at least one chronic condition, chronic care drives most of the healthcare utilization. The findings underscore that healthcare leaders cannot afford siloed care, and the future belongs to organizations that strategically prioritize integrated chronic care models to meet rising demand and manage complexity.
  • McKinsey & Co. points out that “With aging populations and rising chronic disease, improving health span is becoming a societal and economic priority. Here’s what drives it and what can be done.”
  • NAVA Benefits notes,
    • “Women’s health is a career-long conversation, but most benefit packages treat it as a single moment. This piece breaks down six areas where employer coverage still falls short, from menstrual and hormonal health to menopause and chronic conditions, and highlights what leading companies are doing differently. Whether you’re an HR leader benchmarking your benefits or an employee who’s felt the gaps firsthand, it’s a look at what genuinely inclusive coverage can look like.”
  • Per Beckers Hospital Review,
    • “Hospitals and health systems had a rocky start to 2026. Patient demand and revenue growth slowed while expenses intensified, leading to an operating margins dip, according to Strata’s Monthly Healthcare Industry Financial Benchmarks report.”

Thursday report

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers boarded planes Thursday and headed home for the weekend, passing through security checkpoints manned by agents working without pay, as Democrats and Republicans blamed each other for the monthlong impasse over funding the Department of Homeland Security.
    • “Funding for DHS lapsed on Feb. 14, held up over demands from Democrats that new restrictions be placed on Immigration and Customs Enforcement operations as a condition for funding its parent agency. Since then, lawmakers have made no progress in resolving the standoff.
    • “The shutdown has forced a swath of federal workers—including Transportation Security Administration officers at airports—to continue working without pay, contributing to staffing shortages and long security lines at some airports across the country. TSA employees received partial paychecks earlier this month and are due to miss a full paycheck in coming days, just as spring break travel is kicking off. 
    • “Democrats again blocked a measure to fund DHS on Thursday afternoon. Earlier in the day, Republicans blocked a proposal by Democrats to fund individual parts of DHS, including the TSA and Coast Guard but not ICE.”
  • Bloomberg Law relates,
    • “Senate Health, Education, Labor and Pensions Chair Bill Cassidy has a wide range of health care affordability priorities he wants to pursue in 2026, including addressing drug costs and price transparency. 
    • “In terms of the [health care] affordability, it is a campaign issue,” the Louisiana Republican said in an interview at an exclusive Bloomberg Government event on Tuesday.
    • “You can tell Tony Fabrizio is in Donald Trump’s ear, right?” referring to the president’s longtime pollster who has released a survey that shows high drug prices top voter concerns, and many have unfavorable views of pharmaceutical companies. 
    • “Some policies Cassidy thinks could help with affordability are price transparency, site-neutrality in Medicare, which equalizes payments between hospitals and off-site physician offices, and pre-funding health savings accounts to help lower-income people buy insurance. 
    • “There are ways in which the cost of health care is affecting the average American that sometimes flies below the radar,” Cassidy continued.”
  • Beckers Hospital Review tells us,
    • “Sen. Ron Johnson, R-Wis., said he is opening an investigation into the FDA’s rejection of treatments for rare diseases, including ataluren, a drug used by some patients with Duchenne muscular dystrophy.
    • “Mr. Johnson, who chairs the Senate Permanent Subcommittee on Investigations, announced the inquiry at a news conference March 11. He said the FDA should allow patients access to high-risk treatments with clear disclosures rather than remove those options altogether, according to a report from Spectrum News 1.”
  • Federal News Network reports,
    • “Federal annuitants who have been waiting for weeks on a key tax document from the Office of Personnel Management should keep an eye on their mailboxes in the coming days.
    • “In an email sent Wednesday, OPM informed federal retirees who requested physical copies of their 1099-R forms that the remaining paper documents were being sent out this week, and should be delivered in the next three to five days.
    • “If retirees who requested a physical copy of their 1099-R form do not receive it by March 18, they should email OPM, “so that we can look into it and help get you your form,” OPM wrote Wednesday in its message to annuitants, viewed by Federal News Network.
    • “OPM Director Scott Kupor further confirmed on social media that the remaining paper tax documents would be delivered shortly. He said about 93% of annuitants have either downloaded digital copies of their documents, or already received a copy of the tax form in the mail.”
  • Tammy Flanagan, writing in Govexec, tells us,
    • “Women in federal service still face retirement gaps.
    • “Lifetime earnings, career interruptions and caregiving responsibilities continue to shape retirement outcomes for women in federal service.” * * *
    • “While challenges exist, federal employment offers tools that women can leverage so they can prepare for retirement.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration is cracking down on telehealth companies’ marketing of compounded versions of weight loss drugs. In recent months, the agency has warned them against implying that their products are FDA approved, or that they themselves manufacture the products.
    • “But those companies may not be the only ones under the microscope. 
    • “The telehealth companies that have been warned — with names like Lovely Meds, Hello Cake, and MEDVi — don’t directly prescribe the medications, which are not approved by the FDA or evaluated for safety and efficacy. That falls to the clinicians in medical groups affiliated with the companies. And a STAT analysis shows that cited companies can share clinical DNA.
    • “Among more than 70 telehealth companies warned by the FDA in the last six months, at least 30% have publicly stated affiliations with just four nationwide medical groups: Beluga Health, OpenLoop, MD Integrations, and Telegra. 
    • “These “white label” telehealth practices, which allow brands to quickly plug into a stable of clinicians often licensed to practice medicine across the country, have helped telemedicine companies grow rapidly. But in doing so, they are now closely tied to an industry attracting government regulators’ scrutiny.” 
  • Fierce Pharma adds,
    • “Though it’s hard to say exactly what the future holds for mass GLP-1 compounding, the pressure is mounting from multiple angles in the U.S. as drugmakers and the FDA alike seek to crack down on the practice. 
    • “Now, Eli Lilly—which has already staged multiple efforts in court to protect sales of its diabetes and obesity meds Mounjaro and Zepbound from compounders, medical spas and telehealth firms—is launching a new salvo focused on the potential safety risks behind a common compounding tactic. 
    • Lilly cautioned Thursday that through its own testing, it has “uncovered significant levels of an impurity” in certain compounded products marketed in the U.S., which seem to stem from a chemical reaction between vitamin B12 and tirzepatide, the active ingredient in Mounjaro and Zepbound. 
    • “Lilly called the impurity “concerning” given what little is known about its short- or long-term effects in humans, as well as its potential to interact with the GLP-1 itself or how it is absorbed, distributed, metabolized and eliminated from the body. 
    • “The Indianapolis pharma stressed that tirzepatide has never been studied in combination with B12 and warned that the compounders making these products, who are beholden to different regulations than branded drugmakers are, aren’t required to monitor and report potential negative reactions to their medicines.” 
  • Cardiovascular Business lets us know,
    • “Toro Neurovascular, a California-based medtech company focused on developing new treatments for stroke and other neurovascular conditions, has secured U.S. Food and Drug Administration (FDA) clearance for its new Toro 88 Superbore Catheter.
    • “The large-bore device was built to provide support, trackability and stability during the treatment of time-sensitive stroke patients. According to Toro Neurovascular, the company worked closely with physicians to ensure it can deliver value to care teams treating even the most challenging cases. 
    • “Satoshi Tateshima, MD, PhD, a professor of interventional neuroradiology at UCLA, performed the first clinical use case with the Toro 88 device in the United States.”

From the public health, medical and Rx research front,

  • Cardiovascular Business reports,
    • “The U.S. cardiovascular mortality rate decreased dramatically from 2000 to 2011. Since then, however, it has remained relatively unchanged, according to new findings published in JACC.
    • “Cardiovascular mortality in the United States declined steadily for more than five decades; yet, progress slowed beginning around 2010,” wrote first author Adith S. Arun, BS, a research fellow with Yale New Haven Hospital and Yale School of Medicine, and colleagues. “Recent work has described this pattern as a ‘disquieting plateau,’ a period in which gains in cardiovascular outcomes have stalled despite major advances in therapies and an expanding clinical armamentarium. At the same time, national healthcare spending has reached historic levels.” * * *
    • “The researchers did note that the growth in spending is somewhat expected due to an aging patient population and the high costs associated with emerging technologies. At the same time, they wrote, “the value of these technologies depends on both their clinical effectiveness and their pricing.”
    • “The group also highlighted the importance of prevention efforts and lifestyle interventions as health systems look to keep healthcare costs down and potentially get cardiovascular mortality to start dropping again. 
    • “Click here to read the full study in JACC, the flagship journal of the American College of Cardiology.”
  • Beckers Hospital Review relates,
    • “West Virginia had the highest rate of fatal opioid overdoses of any state in 2024, according to a new analysis from KFF. 
    • “The analysis is based on finalized 2024 opioid overdose death totals from the CDC’s WONDER database, which uses ICD-10 codes to identify deaths where synthetic and prescription opioids are listed as a contributing cause. Rates are age-adjusted per 100,000 population using the 2000 U.S. standard population distribution. The data includes both deaths involving illegally manufactured and pharmaceutical fentanyl.
    • “The national opioid overdose death rate was 16 per 100,000 residents in 2024. More broadly, the U.S. recorded its largest-ever annual decline in overall drug overdose deaths, with the national rate falling from 31.3 per 100,000 in 2023 to 23.1 per 100,000 in 2024.”
  • MedPage Today tells us,
    • “This season’s influenza vaccine effectiveness rates against outpatient visits and hospitalizations may be lower than last season’s, according to an interim CDC analysis.
    • “During the current flu season, 88% of subtyped influenza A-positive specimens have been H3N2, 93% of which have been an antigenically drifted subclade K version that’s different from the 2025-2026 flu vaccine virus.
    • “These national trends were mirrored in the nation’s most populous state, California.”
  • and
    • “In cancer patients with brain metastases and type 2 diabetes, those using GLP-1 drugs had a 37% lower risk of death over 3 years.
    • “Significant mortality benefits were linked to semaglutide and dulaglutide, but not with liraglutide.
    • “The risk of all-cause mortality was consistently lower with GLP-1 drugs among patients with primary cancers of the lung, breast, and melanoma.”
  • Infectious Disease Advisor informs us,
    • “Human papillomavirus (HPV) vaccination may provide strong protection among men, highlighting its role in comprehensive disease prevention and gender-neutral control of HPV-related morbidity and mortality.”
  • Health Day notes,
    • “Providing support to stressed-out parents might help their children avoid obesity, a new study says.
    • “Children were more likely to eat healthy and not gain weight if their parents participated in training to help manage stress, researchers reported March 6 in the journal Pediatrics.
    • “We already knew that stress can be a big contributor in the development of childhood obesity,” senior researcher Rajita Sinha, director of the Yale Interdisciplinary Stress Center in New Haven, Connecticut, said in a news release.
    • “The surprise was that when parents handled stress better, their parenting improved, and their young child’s obesity risk went down,” Sinha said.”
  • Science points out,
    • “Scientists have plenty of ideas about why aging impairs memory. Reductions in blood flow in the brain, shrinking brain volume, and malfunctioning neural repair systems have all been blamed. Now, new research in mice points to another possible culprit: microbes in the gut.
    • “In a study published today in Nature, scientists show how a bacterium that is particularly common in older animals can drive memory loss. This microbe makes compounds that impair signaling along neurons connecting the gut with the brain, dampening activity in brain regions associated with learning and memory, the team found.
    • “This is a tour de force,” says Haijiang Cai, a neuroscientist at the University of Arizona who studies gut-brain communication and was not involved in the work. “They define the pathway all the way from aging and bacteria … to cognitive function—it’s really impressive.” However, he and others emphasize it remains to be seen whether a similar mechanism exists in humans—and if so, how important it is compared with other drivers of cognitive decline.”
  • STAT News relates,
    • “Jim Wells, a biologist at the University of California San Francisco, was studying proteins on the surface of cancer cells when he noticed one that wasn’t supposed to be there. This protein, called Src, should only be tucked inside cells.
    • “An accident,” he said, and a serendipitous one. Wells and his team report in Science that they have found Src on the surface of malignant cells, not healthy donor tissue.  This discovery may bring scientists closer to a long-sought goal: finding an ideal immunotherapy target for solid tumors.
    • “It was certainly provocative and exciting to see this cancer-associated Src kinase now presented on the cell surface,” said Kathleen Yates, a biologist at the Broad Institute of MIT and Harvard University who did not work on the study. But, she added, it’s still too early to know how much clinical benefit there will be from targeting Src on the cell surface. “They’ve accomplished a great deal. It is an outstanding question as to whether this will be translationally impactful,” she said.”
  • Genetic Engineering and Biotechnology News adds,
    • “After becoming the world’s first patient treated with a bespoke base editing therapy, baby KJ Muldoon is now healthy and free from the toxic ammonia buildup caused by his rare genetic metabolic disorder that initially presented a 50% mortality rate in infancy. While his story highlights the life-changing potential of gene editing, it also underscores a major challenge for the field: expanding these therapies to benefit broader patient populations.  
    • “KJ’s urea cycle disorder stemmed from a single disease-causing mutation that could be precisely targeted. However, many genetic disorders arise from numerous mutations scattered across a gene, making individualized corrections far too resource-intensive to scale.
    • “Ben Kleinstiver, PhD, associate investigator at Massachusetts General Hospital (MGH) and co-author of the NEJM study describing KJ’s case, told GEN that insertion of large DNA sequences at programmable locations in the genome holds tremendous promise as a generalizable medicine that could treat patients regardless of their underlying disease-causing mutations. His team has recently taken one step closer to making large gene insertions safer for therapeutic applications. 
    • ‘In the new study published in Nature titled, “Immune evasive DNA donors and recombinase license kilobase-scale writing,” Kleinstiver and colleagues, in collaboration with Full Circles Therapeutics, have developed a circular single stranded DNA donor (ssDNA) that enables kilobase-scale integration while remaining non-toxic to cells.”

From the HIMSS Conference 2026,

  • Fierce Healthcare reports,
    • “The Department of Health and Human Services (HHS) is ramping up major federal interoperability initiatives on several fronts.
    • “As part of this interoperability work, the Trump administration unveiled in July a sweeping health tech initiative that aims to modernize Medicare and advance next-generation digital health for patients, including conversational artificial intelligence, digital IDs and easier ways to access health data.
    • “The Centers for Medicare & Medicaid Services (CMS) is spearheading an API-focused data exchange framework to enable sharing of patient medical records through a new initiative called the CMS Aligned Network. This work is meant to accelerate data sharing at a faster pace than can be achieved through regulations alone, according to Amy Gleason, acting administrator, U.S. DOGE Service, and strategic advisor to the CMS.”
  • The Wall Street Journal adds.
    • “Microsoft MSFT is betting on healthcare as a path to become more competitive in artificial intelligence. The company’s biggest push yet: a new tool it describes as an AI concierge doctor—one that can access your medical records and health data, with your consent. 
    • “The company on Thursday unveiled Copilot Health, a feature within the Copilot app that lets the chatbot dispense personalized healthcare advice informed by the user’s disease history, test results, medications, doctors’ visit notes and biometric data as recorded by wearable devices. 
    • “Health data imported into the feature will be encrypted and firewalled from the rest of the app to address the privacy concerns of handing over one’s medical records to a generative AI platform, Microsoft AI Chief Executive Mustafa Suleyman said in an interview.
    • “It’s something that Microsoft is uniquely placed to do with our scale, with our regulatory experience, with the kind of trust and confidence that people have in our security and the history that we have as a mature, stable player,” Suleyman said.”

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

  • Modern Healthcare reports,
    • “North Dakota rural hospitals are showing they don’t need the help of a large health system to provide more primary care while driving down costs.
    • “In 2023, more than 20 critical access hospitals formed the Rough Rider High-Value Network, seeking to share data and collective resources to standardize care and improve financial performance.
    • “It’s been less than three years, but the network’s early results are a good sign for the concept given the pressure on margins at all hospitals, and especially those in far-flung communities. Rural providers in five other states have since banded together in similar coalitions of independent hospitals while many of their peers join larger health systems.” 
  • Beckers Health IT relates,
    • “More than 80% of physicians use artificial intelligence in their professional practice — more than double the share in 2023, according to a March 12 survey from the American Medical Association.
    • “AMA polled 1,692 U.S. physicians across various specialties, practice settings and career stages about their use and perception of AI. Responses were collected between Jan. 15 and Feb. 2. About 38% of participants practiced in group settings and 24% in hospitals.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (Takeda Pharmaceutical Co., Ltd.) for narcolepsy type 1.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “Register for ICER’s Early Insights Webinar
    • “On March 24, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Vice President of Research, Foluso Agboola, MBBS, MPH, will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.
    • “Submit a Public Comment
    • “The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on April 7, 2026. * * *
    • “ICER’s Patient Portal and Manufacturer Engagement Guide  provide additional detail on what types of information may be most informative to the report.”

Midweek report

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Obesity, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Healthcare Dive reports,
    • “Overpayments to Medicare Advantage plans are causing seniors’ Medicare premiums to spike by billions of dollars, according to new report from congressional investigators.
    • “Medicare Part B premiums rose by $212 per enrollee in 2025, totaling $13.4 billion in higher premiums, due to health insurer practices like recording extra member diagnoses to inflate government reimbursement, the report from the Joint Economic Committee published Tuesday found. [FEHBlog note — CMS tells us that the Medicare premium rose $10.30 monthly from 2024 to 2025 or $123.60 annually]
    • “Health insurance groups argued that the report is based on flawed data and that MA saves money and drives better health outcomes for enrollees.”
  • Beckers Payer Issues relates,
    • “Elevance said it was “surprised and disappointed” by a recent CMS sanction threat, which would suspend enrollment in Medicare Advantage prescription drug plans, CFO Mark Kaye said March 10 at the Barclays 28th Annual Global Healthcare Conference in Miami.
    • “The executive claimed Elevance flagged provider-submitted diagnosis codes and shared information with CMS “in good faith.”
    • “The issues CMS raised relate to historical risk-adjustment processes. They do not reflect our current operating processes or practices,” he said.
    • “Mr. Kaye said he views the issue as a misalignment with policy interpretation.
    • “This is not simply a data submission issue. We view this as a broader policy and payments dispute about how retroactive corrections should be treated under the risk-adjustment framework that was in place during that period,” Mr. Kaye said. “This is a disagreement over the interpretation of policy. It’s not an unwillingness to correct inaccurate data.” He said the rules at the time were in line with Elevance’s conduct.” 
  • The Hill brings us up to date on the Department of Homeland Security shutdown.
  • Per CMS news releases,
    • “The Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS) is committed to improving health care and outcomes, and strengthening accountability, across the nation’s health- and long-term care systems.
    • “Over the next several years, CCSQ will focus on five strategic goals—Prevention, Quality and Safety, Coverage Innovation, Data and Technology, and Burden Reduction. These priorities build on CCSQ’s core mission to establish national health and safety standards; implement quality measurement, reporting and improvement; and support Medicare’s coverage determinations. Together, they represent a roadmap for health- and long-term care systems that are safer, stronger, and more transparent.”
  • and
    • The Centers for Medicare & Medicaid Services (CMS) today issued new guidance to strengthen public trust and ensure patients and their families are treated with dignity and care throughout the organ donation process. The guidance clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion. This action follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief. 
  • Govexec tells us,
    • “The No. 1 thing to know entering retirement: How much are you really spending?
    • “Many new retirees may overestimate how far their savings will go towards their budget. Having an idea of your cost of living can make them go further.”

From the Food and Drug Administration,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.  
    • “The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
  • Health Exec informs us,
    • “The U.S. Food and Drug Administration has released an early alert pertaining to patient safety, after the agency said it became aware of an issue with flexible cryoprobes—used to deliver extreme cold to a site on the body for a variety of medical purposes, including removing tissue tumors—manufactured by Erbe USA.
    • “According to the FDA, the company reported incidents of its cryoprobes “rupturing or bursting during activation,” leading to excessive pressure at sites of foreign bodies, mucus plugs, blood clots, necrotic tissue, or biopsies—essentially anything a provider is trying to remove.”

From the public health, medical and Rx research front,

  • The New York Times reports,
    • “In a survey by the health research group KFF and The Washington Post, released in September, 16 percent of parents said they had skipped or delayed at least one childhood vaccine other than for flu or Covid-19. And doubts about vaccines are increasingly spilling into refusal of other mainstays of pediatric medicine, including antibiotics, medications like Tylenol and diagnostic procedures like spinal taps.
    • “At a hospital in Boise, Idaho, for example, three infants died last year after their parents declined a shot of vitamin K, administered to newborns to prevent bleeding, said Dr. Amanda Lee, a pediatrician there.
    • “Parents have always had questions about vaccines, but Dr. Lee and other pediatricians say they are now finding their expertise to be sometimes powerless against the flood of misinformation.” * * *
    • “Conferences of pediatricians now routinely hold workshops on earning parents’ trust. They are training clinicians to be less authoritarian, less judgmental and more patient, said Dr. Brandan Kennedy, a pediatric hospitalist in Kansas.”
  • Medpage Today tells us,
    • “Semaglutide for weight loss (Wegovy) was associated with a significantly higher risk of ischemic optic neuropathy (ION) compared with the diabetes formulation (Ozempic) and other GLP-1 agonists.
    • “Added to the existing evidence base, the study suggests a dose-dependent risk of ION.
    • “Men treated with Wegovy had a threefold higher risk of ION versus women.”
  • and
    • “The COBRRA trial directly tested apixaban and rivaroxaban, the oral anticoagulants most frequently used to treat acute venous thromboembolism.
    • “The risk of clinically relevant bleeding came out significantly lower with apixaban than with rivaroxaban during the 3-month treatment period.
    • “The study-specific dosing regimen may have played a role in the results, however.”
  • and
    • “Over 40% of smokers who received one psilocybin dose quit by month 6 versus 10% of nicotine patch users in a pilot randomized trial.
    • “No serious adverse events were reported, and the most common side effects with psilocybin were temporary increases in blood pressure and nausea.
    • ‘Psilocybin works by increasing “mental flexibility,” allowing patients to reframe their relationship with addiction, researcher said.”
  • Health Day lets us know,
    •  “Women who have pregnancy complications might face a higher risk of heart disease, a new study has concluded.
    • “The stress of these complications increase a woman’s risk of high blood pressure for years after they deliver, researchers reported March 9 in the journal Hypertension.
    • “For women who were having babies for the first time and had complications, referred to as adverse pregnancy outcomes, we found that higher stress levels over time were associated with higher blood pressure levels two to seven years after delivery,” lead researcher Virginia Nuckols, a postdoctoral fellow at the University of Delaware, said in a news release.”
  • and
    • “An already-approved IV drug significantly reduces the symptoms of lupus, a new clinical trial showed.
    • “More than three-quarters of lupus patients taking obinutuzumab (Gazvya) had a significant improvement in their symptoms after a year on the drug, researchers reported March 6 in The New England Journal of Medicine.
    • “The drug also improved time between lupus flares, and had a more than doubled remission rate compared to placebo, researchers said.”
  • Genetic Engineering and Biotechnology News informs us,
    • “Researchers headed by a team at the University of California San Diego have found that a novel blood-based biomarker can predict a woman’s risk of developing dementia as many as 25 years before symptoms appear. The study, involving more than 2500 women, showed that higher levels of phosphorylated tau 217 (ptau217)—a form of tau protein that reflects early brain changes associated with Alzheimer’s disease—were strongly associated with future mild cognitive impairment (MCI) and dementia among older women who were cognitively healthy at the start of the study, before any memory or thinking problems were detected.
    • “Our study suggests we may be able to identify women at elevated risk for dementia decades before symptoms emerge,” said Aladdin H. Shadyab, PhD, MPH, UC San Diego associate professor of public health and medicine at the Herbert Wertheim School of Public Health and Human Longevity Science and the School of Medicine. “That kind of long lead time opens the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life.”
  • MedPage points out,
    • “The nation’s safest hospitals, according to annual rankingsopens in a new tab or window from Healthgrades, represent the top 10% of hospitals nationwide for patient safety, with the lowest incidences of 13 preventable patient safety events.
    • “Patients treated at these 438 hospitals, located across 40 states, were significantly less likely to experience the four most common patient safety indicators, characterized as serious, preventable complications, which account for 78% of all safety events, including:
      • “In-hospital falls resulting in fracture: 52.4% less likely
      • “Collapsed lungs due to a procedure or surgery in or around the chest: 57.5% less likely
      • “Catheter-related bloodstream infections acquired in the hospital: 67.8% less likely
      • “Pressure sores or bed sores acquired in the hospital: 71.9% less likely
    • “The data behind this year’s Patient Safety Excellence Award highlights how measurable improvements in safety can prevent thousands of complications,” said Alana Biggers, MPH, medical advisor at Healthgrades, in a press release.
  • Per BioPharma Dive,
    • “Biogen on Wednesday unveiled updated data showing its spinal muscular atrophy drug salanersen slowed neurodegeneration and improved motor function in an early-stage study.
    • “The trial enrolled patients who had already been treated with the Novartis’ gene therapy Zolgensma, and found a reduction of 75% in neurofilament light chain levels, a measure used to evaluate neurodegeneration. Half of those patients also achieved a motor function milestone according to World Health Organization standards.
    • “As part of the update, Biogen also revealed the design for a late-stage study that includes three separate trials of salanersen in newborns, infants already treated with Zolgensma, and teens and older adults who have either not been treated or previously took another SMA drug, Roche’s Evrysdi.”
  • Per Fierce Pharma,
    • “After strutting its stuff against blockbusters in three head-to-head psoriasis trials, UCB’s Bimzelx has conquered another powerhouse product—AbbVie’s Skyrizi—in psoriatic arthritis (PsA).
    • “A phase 3b study of 553 adults with active psoriatic arthritis has achieved its primary objective, showing the “statistically significant superiority” of Bimzelx over Skyrizi in reducing disease activity as measured by the ACR50 endpoint at Week 16, the Belgian company said.”
    • “ACR50 is a composite efficacy measurement, specified by the American College of Rheumatology, which indicates 50% or greater improvement from baseline in tender or swollen joint counts in addition to 50% improvement in three of five other disease markers.”  

From the HIMSS conference front,

  • Fierce Healthcare reports,
    • “Epic is ramping up more artificial intelligence capabilities and features as it also touts how its AI tools drive measurable outcomes beyond just faster documentation time. 
    • “Health systems are reporting earlier diagnoses, fewer denials and improved patient experiences, the company said.
    • “At the 2026 Healthcare Information and Management Systems Society (HIMSS) Global Health Conference & Exhibition, which kicked off Monday, Epic teased its future AI road map with new features across clinical, patient-facing and operational workflows.”
  • and
    • “Samsung Electronics and digital health company b.well Connected Health are working together to toss out the traditional patient clipboard and replace it with smartphones.
    • “Samsung Galaxy smartphone users, through the Samsung Health app, will now have digital access to their complete health history and can share their medical record with participating providers via a QR code. That eliminates the intake paperwork patients fill out at nearly every healthcare visit, according to the two companies. 
    • “Despite advances with technology, patients typically still fill out the same paperwork at the doctor’s office and often have to repeat pertinent medical information from memory and log into multiple portals.”
  • Health Tech Magazine adds,
    • “Documentation overload, clinical burnout and rising operational costs are just some of the challenges healthcare organizations face today. This can have a major impact on clinician satisfaction and retention.
    • “Microsoft Dragon Copilot is one way health systems can address these concerns. The artificial intelligence-powered tool streamlines clinical documentation, giving clinicians more time in their day for seeing additional patients or other important tasks. In addition to improving clinical workflows, Dragon Copilot improves documentation, creates more accurate coding and improves the patient experience.
    • “At HIMSS26 in Las Vegas, HealthTech spoke with two Microsoft Dragon Copilot experts about what problems it solves, how it integrates with the electronic health record, how it can be used across departments and clinical specialties, and tips for implementation success.”
  • Healthcare Dive notes,
    • “Amazon is expanding access to its health-focused artificial intelligence chatbot, the technology giant said Tuesday. 
    • “The Health AI assistant first launched for members of Amazon’s primary care chain One Medical in January. The tool allows users to connect their health information and ask questions about their health, symptoms and potential treatments. 
    • “Now, the tool is rolling out to all U.S. consumers. “The desire to ask questions of an AI agent is enormous,” Dr. Andrew Diamond, chief medical officer at Amazon One Medical, told Healthcare Dive at the HIMSS conference Tuesday. “It is clearly the fastest way for people to get their basic health questions answered. And even basic is almost putting it too simply. They’re getting pretty in-depth questions answered.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “American hospitals saw expenses grow 7.5% in 2025, more than twice the rate of growth in hospital prices that year, according to the American Hospital Association’s annual “Costs of Caring” report.
    • “The findings, which were drawn from industry benchmark data compiled by Strata Decision Technology, point to a system under mounting strain: Hospitals are treating more patients, those patients are getting sicker and the cost of supplies from drugs to disposable gloves is increasing quicker than reimbursements can keep up with.
    • “Rising costs for labor, supplies, drugs, and administrative burdens caused by corporate insurers, combined with caring for sicker patients, have created challenges for hospitals and health systems,” AHA President and CEO Rick Pollack said in a March 11 news release shared with Becker’s. “These strains are jeopardizing hospitals’ ability to provide around-the-clock care and services that patients and communities need.”
  • and calls attention to ten hospital M&As finalized in 2026.
  • Fierce Healthcare relates,
    • “It’s not a secret that commercial payers are navigating an earnings slump.
    • “Weighed down by elevated member utilization and staring down stagnant proposed Medicare Advantage (MA) rates for 2027, insurers are looking to lessen the pain by securing more favorable network contracts with providers and increasing scrutiny of reimbursement claims.
    • “The former has recently led to some high-profile dustups in which MA contracts with health systems are permitted to expire, while the latter has forced hospitals to devote more resources toward combating denials. 
    • “However, for-profit hospital and ambulatory surgery center chain Tenet Healthcare isn’t viewing payer pushback as a major headwind. In last month’s earnings call, executives told analysts that its commercial rate updates are so far landing in a healthy range of 3% to 5%. The company is also almost entirely contracted for 2026, and about 80% contracted for 2027, they said.”
  • and
    • “Carrum Health, which offers value-based specialty care for employers, is teaming up with Virta Health on weight management.
    • “Virta offers virtual counseling, nutrition coaching and medication management with GLP-1s. Employers can customize Virta’s offering depending on their benefits. Meanwhile, Carrum has already provided bariatric surgeries for weight management. 
    • “Now, members can be referred and coordinated between the two as needed.”
  • Fierce Pharma tells us,
    • “Twelve months ago, drugmakers came roaring into 2025, fueled by a massive year of growth that peaked in the fourth quarter of 2024. Now, the momentum has dissipated, and most companies are bracing for a slowdown in sales heading into 2026. 
    • “In fact, over the last few weeks of earnings reports, drugmakers’ financial results were less noteworthy than their guidances. Of 25 companies with quarterly revenue of at least $2 billion that had reported through March 5, just five projected that their sales would grow at a higher rate in 2026 than in 2025, with each of those increases slight.
    • “The pharmas offered a variety of reasons—macro and micro—for their pessimistic 2026 projections. Several mentioned pricing effects related to the Inflation Reduction Act (IRA), as well as U.S. President Donald Trump’s most-favored-nation plan and his threats of tariffs on pharmaceutical products. An anticipated decline in vaccine sales, linked to a demand shortfall in the U.S., also plays into the computation for several companies, while many others are dealing with the loss of exclusivity (LOE) of blockbuster products.”

Tuesday report

David Ermer–CDC, Congress, Employee Wellness Programs, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • The Washington Post reports on the continuing shutdown of the Department of Homeland Security.
  • Federal News Network reports,
    • “Agencies are closing in on an opportunity to hire talent for temporary technology jobs, after the Office of Personnel Management released its first two shared certificates on Tuesday for the Trump administration’s “Tech Force” program.
    • “Lists of eligible candidates for software engineering and data engineering positions are now available for participating agencies to review and potentially hire, an OPM spokesperson confirmed to Federal News Network. If hired, selected employees would move into two-year roles to temporarily work on technology-related initiatives.
    • “Candidates who are listed on the new shared certificates have already passed three rounds of hiring evaluations, including a technical assessment, a resume review and a screening interview, said OPM Director Scott Kupor.”
    • “We hope to have several hundred people now who passed all three phases of that, where we will put them on a shared certificate, and then we will start to push that certificate out to all the participating agencies,” Kupor said during a March 5 event hosted by Federal News Network. “The agencies then have an opportunity, if they so choose, to do an additional round of interviews, if they want to make sure the person is the right fit for their organization.”
  • MedTech Dive tells us,
    • “The Advanced Research Projects Agency for Health, or ARPA-H, launched a new program on Tuesday to support development of biosensors that can track multiple signals such as inflammation markers, hormones or drug levels within the body.
    • ‘The program, called Delphi, will focus on using electronic “chiplets,” with the goal of being able to “mix and match” features across wearables and ingestible sensors.
    • “The initiative comes as Health and Human Services Secretary Robert F. Kennedy Jr. has emphasized a role for wearables in tracking health habits. Last year, the secretary said he wanted all Americans to use wearables, and the Food and Drug Administration’s device center launched a pilot that would allow the agency to waive premarket requirements for certain digital health devices while they collect real-world data under a Medicare program.”
  • Kevin Moss, writing in Federal News Network, points out special features of FEHB and PSHB plans.

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. touted leucovorin as “an exciting therapy that may benefit large numbers of children who suffer from autism” during a White House press conference, the FDA has approved the decades-old drug for a rare genetic condition with “autistic features” that represents a small subset of autism patients.
    • “The FDA has approved GSK’s brand-name leucovorin calcium tablets, Wellcovorin, to treat cerebral folate deficiency (CFD) but only in patients who have a confirmed variant in the folate receptor 1 (FOLR1) gene.”
  • and
    • “Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application, with Incyte announcing Friday that the FDA handed over a complete response letter for its PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer (NSCLC).
    • “The rejection was not related to any efficacy or safety concerns but rather inspection findings at a fill-finish facility—specifically, the former Catalent plant in Bloomington, Indiana, which is now owned by Novo as part of Novo Holdings’ $16.5 billion acquisition of the CDMO in 2024.
    • “The setback comes more than a year after Incyte detailed a 25% reduction in the risk of death for a combination of Zynyz and chemotherapy versus chemo alone among patients with newly diagnosed metastatic NSCLC in the phase 3 Pod1um-304 trial.” * * *
    • “In a March 9 statement to Fierce Pharma, a Novo spokesperson said the company is “actively engaging with the agency to address its findings.”
  • Beckers Hospital Review informs us,
    • “Ipsen, a Paris-based drugmaker, is removing its cancer drug Tazverik (tazemetostat) from the U.S. market because of safety concerns. 
    • “An ongoing Tazverik clinical trial has reported adverse events of secondary hematologic malignancies — which are blood cancers — indicating “the risks may outweigh potential benefits for patients,” Ipsen said in a March 9 news release. 
    • “The FDA granted Tazverik accelerated approval in 2020. The drug is approved to treat epithelioid sarcoma, a rare, aggressive soft tissue cancer that affects a few hundred patients each year, and relapsed or refractory follicular lymphoma, a form of non-Hodgkin lymphoma.
    • “The company said it is voluntarily withdrawing Tazverik in all indications.”

From the judicial front,

  • Beckers Payer Issues reports,
    • “On March 8, a judge for the U.S. District Court in Connecticut approved a preliminary injunction against Aetna, ordering the insurer to alter its gender-affirming care policy for two plaintiffs.
    • “Several transgender women sued Aetna in 2024 over denied gender-affirming facial reconstructions. The complaint pointed to Aetna’s Clinical Policy Bulletin 0615, which outlines parameters for gender-affirming care.” * * *
    • “Under the preliminary injunction, Aetna must individualize coverage for Jamie Homnick, PhD, and Gennifer Herley, PhD, two of the plaintiffs. Both women lack access to this coverage and have been facing depressive symptoms due to gender dysphoria, a court document said.
    • “Aetna has a strong track record as a proud ally of the LGBTQ+ community and is committed to meeting the healthcare needs of all our members. As a third-party administrator for self-funded plan sponsors, our role is to administer benefits in accordance with the specific terms set forth by each plan,” Aetna said in a statement shared March 10 with Becker’s. 
    • “Many employer benefit plans may include customized coverage for gender-affirming procedures. We work closely with our plan sponsors to meet their unique needs and preferences while complying with all applicable regulations and legal requirements,” the statement continued. “We strongly disagree with the allegations in this lawsuit and will defend ourselves vigorously.” 
  • Here’s a link to the Leapfrog CEO Leah Binder’s statement about the Tenet Healthcare decision mentioned in yesterday’s post.
  • Per a Justice Department news release,
    • “The Department of Justice released today the first-ever Department-wide corporate enforcement policy for criminal matters, promoting uniformity, predictability, and fairness in how it pursues white-collar cases to protect the American people.”

From the public health and medical / Rx research front,

  • Bloomberg Law reports,
    • “South Plains, Texas, had long declared its measles outbreak over when in January wastewater testing picked up what Zachary Holbrooks called “a blip, a spike.”
    • “The testing found measles after months without traces of the virus, which by the 2025 West Texas outbreak’s end infected over 750 people, hospitalized nearly a hundred, and two children died.
    • “With samples sent to Baylor University weekly, subsequent testing hasn’t picked up further traces, said Holbrooks, executive director for the South Plains Public Health District. The goal is to “test long-term” and see “if anything shows up.”
    • “With the Centers for Disease Control and Prevention reporting over 1,200 confirmed measles cases and 12 new outbreaks in 2026, states across the US are taking similar steps to those taken in West Texas to manage infections, mounting outreach strategies, easing access to vaccines, and more.
    • “Working against such efforts are low vaccination rates in pockets of states where misinformation and distrust of government spur outbreaks.
    • “Any state should be looking across its communities and identifying areas where the vaccination rates are lower than 95%. Those are the places that are very ripe for outbreaks,” said Jennifer Nuzzo, director of Brown University’s Pandemic Center.”
    • “Given 2025’s outbreak cycle, states should’ve been better prepared, Nuzzo said. Now, they’ll need to undertake “the very slow, laborious ground game of building trust” in communities to encourage vaccination.”
  • The latest issue of NIH’s Research Matters covers the following topics:
  • Healio relates
    • “Adults with type 2 diabetes who adhered to eight healthy lifestyle habits had a 60% lower risk for cardiovascular events than those who reported zero or one healthy lifestyle habits, researchers reported.
    • “In a prospective cohort study of adults with type 2 diabetes enrolled in the U.S. Veterans Affairs Million Veteran Program, researchers assessed the risk for major adverse CV events according to the number of self-reported healthy lifestyle habits for each participant. The risk for CV events declined with each additional lifestyle habit a person reported, and the findings were similar regardless of whether adults were using a GLP-1 receptor agonist.”
  • and
    • “Risks for cognitive impairment increased with more advanced chronic kidney disease (CKD) stages. 
    • “Associations were strongest for higher urinary protein-to-creatinine ratio plus lower eGFR. ***
    • “Our findings suggest that measures of CKD severity may be relevant to consider in combination with known dementia risk factors, such as age or comorbid conditions,” [Tanika} Kelly [PH.D, MPH] told Healio. “Cognitive screenings should be considered if a patient or family member notice cognitive or behavioral changes.”
  • Health Day informs us,
    • “People think of aging as a steady decline, with seniors gradually losing their physical abilities and mental agility as the years wear on.
    • “But a new study suggests that seniors can – and often do – improve over time, with the right mindset.
    • “Nearly half of seniors 65 and older showed measurable improvement in their brain health, physical function or both over time, researchers reported in the journal Geriatrics.
    • “Many people equate aging with an inevitable and continuous loss of physical and cognitive abilities,” lead researcher Becca Levy, a professor of social and behavioral sciences at the Yale School of Public Health, said in a news release.
    • “What we found is that improvement in later life is not rare, it’s common, and it should be included in our understanding of the aging process,” Levy said.”
  • and
    • “Smoking weed, taking a hit of cocaine or popping some amphetamines can raise a person’s risk of stroke – even if they’re a younger adult.
    • “Coke and amphetamines can double or triple the risk of stroke for any adult, researchers reported in the International Journal of Stroke.
    • “Weed also increases stroke risk, but to a lesser extent, British researchers said.
    • “This is the most comprehensive analysis ever conducted on recreational drug use and stroke risk and provides compelling evidence that drugs like cocaine, amphetamines, and cannabis are causal risk factors for stroke,” lead researcher Megan Ritson said in a news release. She’s a postdoctoral research associate with the University of Cambridge.”
  • Cigna, writing in LinkedIn, discusses how employers can help improve the mental health of their male employees.
    • “Men face unique barriers to seeking mental health support, including stigma, societal expectations, and concerns about confidentiality at work.
    • “Untreated mental health conditions among men contribute to higher healthcare costs, absenteeism, and turnover.
    • “Employers that normalize mental health conversations, protect privacy, and offer tailored support men’s mental health can improve outcomes for employees and business performance.”
  • STAT News notes
    • “Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • “Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
    • Several years ago, nephrologists attempted a first-of-its-kind effort: remove race from a key clinical algorithm, and attempt to undo the harms of the race-based equation for those who were still being negatively affected by it. 
    • Until 2021, eGFR, which is used to measure kidney function, was inflated by around 16% to 21% for Black patients — which could mask severe kidney disease and delay urgently needed transplants. Not only was the equation phased out in 2022, but the Organ Procurement and Transplantation Network mandated that transplant programs submit modifications for Black patients waiting for transplants. 
  • and
    • “Vertex said Monday that a drug it secured as part of a $4.9 billion acquisitionsuccessfully reduced by half a key marker of a kidney disease known as IgA nephropathy.
    • “The results, from a Phase 3 trial, match data from a study of Otsuka’s recently approved Voyxact and are numerically superior to data released last year by Vera Therapeutics.
    • “All three companies have been racing to treat a disease that affects 330,000 people across the U.S. and Europe, according to Vertex’s estimates, putting many at risk of developing end-stage renal disease. Analysts have projected Vertex’s drug could eventually bring in $4 billion or more in annual sales.” 

From the HIMSS conference front,

  • Health Tech Magazine reports,
    • The HIMSS Global Health Conference and Exhibition is back in Las Vegas this year, with the tagline “Expert Insights, Exceptional Impact.” 
    • The annual conference kicks off Tuesday with an opening keynote from venture capital leader Jon McNeill (whose experience includes Tesla and Lyft) and Dr. John Halamka, the Dwight and Dian Diercks President of the Mayo Clinic Platform. 
    • Other notable keynote speakers throughout the week include Sumbul Ahmad Desai, vice president of health and fitness at Apple, on Wednesday; and Dr. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, on Thursday (the final day of the conference). 
    • Before HIMSS 2026 began in full swing, Monday saw a day of preconference sessions organized around topics such as artificial intelligence in healthcare, cybersecurity, interoperability and health information exchanges, among others. 
    • The AI in healthcare preconference track saw healthy attendance with a focus on tangible use cases and lessons on how to deploy AI into improved or better-integrated workflows.
  • Heathcare Dive digs into regulation of artificial intelligence issues.
  • MedCity News adds,
    • “Verily and Samsung are teaming up to accelerate clinical research using wearable data, the companies announced Monday at the HIMSS conference in Las Vegas. 
    • “The companies are integrating user data from Samsung Galaxy smartwatches into Verily’s precision health platform, Verily Pre, so pharma companies and government agencies can run studies and monitor participants remotely.
    • “Researchers will be able to collect continuous health data from study participants wearing Samsung watches, including metrics such as heart rate, sleep and physical activity. The information will flow back into Verily’s data platform, allowing pharma companies and regulators to track patients’ health over time and quickly analyze real-world data.
    • “Consumer wearables are becoming “real, bonafide research-grade instruments,” according to Myoung Cha, Verily’s chief product officer.” 
  • In related news, “Ratnakar Lavu, chief digital information officer at Elevance Health, sat down with MobiHealthNews for an in-person interview to discuss the framework the health insurance company uses to validate and scale AI in healthcare.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Centene’s stock took a nosedive on Tuesday as the company’s top brass offered further color on the marketplace headwinds battering its performance.
    • “CEO Sarah London said during the Barclays Global Healthcare Conference that membership in its Affordable Care Act exchange plans was down to 3.6 million as of February, from 5.5 million at the end of 2025. She said the team expects that to decline further to about 3.5 million by the end of Q1.” * * *
    • “The company had braced for a likely downturn in enrollment following the expiry of the enhanced premium tax credits and the planned implementation of program integrity measures that proved controversial in the industry.” * * *
    • “Given that these shifts are driven in part by the end of the enhanced subsidies, London said that the member mix in the bronze tier does look different than in years past. Prior to the rollout of the enhanced subsidies in response to the pandemic, the bronze tier was largely made up of younger, healthier individuals.
    • “Now, the insurer is seeing people select a bronze plan because it’s a lower cost option to ensure they maintain coverage, even if they were previously in a silver or gold plan, she said.”
  • Modern Healthcare relates,
    • “Elevance Health is expanding [to California] a policy to penalize hospitals that refer patients to out-of-network providers. [The purposes of this sensible policy is to reduce No Surprises Act claims.}
    • “The insurance company has introduced the policy in at least 11 other states. 
    • “The American Hospital Association and Federation of American Hospitals have pushed back against the policy.”
  • Beckers Hospital Review tells us,
    • “Private equity firms have become a major force in healthcare, investing more than $1 trillion over the last ten years, according to a recent report from New York University’s Stern Center for Business and Human Rights.
    • “The report, published March 10 and authored by Michael Goldhaber, examines how private equity’s investments have impacted patient care, hospital finances and medical access.
    • “There is a healthcare crisis in the United States. Costs are rising, driven by market consolidation, increased insurance premiums, escalating drug prices and other changes,” the report said. “Many hospitals and healthcare facilities are experiencing staffing shortages. These and other factors mean that the poorest people in the U.S. have worse health outcomes than those in other high-income countries, despite the high level of spending.”
  • Fierce Healthcare adds,
    • “Highly concentrated—and, by extension, less economically competitive—hospital markets are ubiquitous across the country and the norm in rural states Wyoming, North Dakota and South Dakota, according to a market analysis tool unveiled this week by Yale University’s recently launched Health Care Affordability Lab.
    • “Every hospital in those three states operates in a market deemed to be highly concentrated or even monopolistic based on their Herfindahl-Hirschman Index (HHI), a metric used by the “Federal Trade Commission (FTC) and the Department of Justice (DOJ) to determine when it should intervene in a deal on competitive grounds. 
    • “More broadly, the tool shows that 94% of the nation’s hospitals operate in markets with HHIs above 1,800, reflecting a highly concentrated market.” 
  • BioPharma Dive lets us know,
    • “Ugur Sahin and Özlem Türeci, who co-founded BioNTech and led its rise to prominence as a COVID-19 vaccine maker, are leaving the company to establish a new startup focused on mRNA technology. 
    • “BioNTech said Tuesday that Sahin and Türeci, who’ve been serving as CEO and Chief Medical Officer, respectively, will step down by the end of the year. Afterwards, they’ll steer a startup working on “next-generation mRNA innovations.” BioNTech will grant that unnamed biotech certain rights to its mRNA technology in exchange for a minority stake, but won’t provide ongoing capital support, the company said.
    • “BioNTech, meanwhile, will focus on advancing a late-stage portfolio that now includes several different cancer medicines. The company said its supervisory board has initiated a search to identify successors for Sahin and Türeci and ensure a “smooth transition.” It’ll provide more details on the partnership with the new startup once an official deal is signed. Paperwork should be completed by the end of the first half.”
  • Beckers Hospital Review points out,
    • “Statista, a global data company that publishes insights for 170 industries, projects four cancer therapies will be among the top 10 best-selling pharmaceutical products in the U.S. this year. 
    • “The company projects Merck’s cancer drug Keytruda will earn $12.7 billion in U.S. revenue in 2026 — nearly twice that of the second top-selling medication, according to data shared March 9 with Becker’s. 
    • “[The article identifies] the medications Statista projects will be the 10 best-selling U.S. pharmaceutical products in 2026.”
  • Fierce Pharma notes,
    • “Sandoz has not minced words about the massive yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade. 
    • “Now, in an effort to fully capitalize on what the company recently referred to as a potential “‘golden decade’ of affordable medicines” after 2030, Sandoz is committing even further to its biosimilar business with plans to launch a dedicated unit that will operate separately from the company’s remaining small molecule generics division.”
    •  “The new biosimilar unit, focused on development, manufacturing and supply of copycat biologic drugs, will be led by Armin Metzger, most recently chief technical operations officer at fellow Swiss drugmaker Ferring Pharmaceuticals.”
  • Per MedTech Dive,
    • “Medtronic said Tuesday it agreed to acquire neurovascular technology company Scientia Vascular for $550 million, with the potential for undisclosed milestone payments after the acquisition.
    • “Scientia’s neurovascular access devices are used to navigate the brain’s complex vasculature to treat conditions such as strokes and aneurysms.
    • “The Scientia proposal is Medtronic’s second deal of the year, after the company announced an acquisition of CathWorks for up to $585 million in February.”

Monday report

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

From Washington, DC

  • Federal News Network reports,
    • “Federal employees’ retirement applications are continuing to flood the Office of Personnel Management. In February, another 31,000 retirement claims entered the agency’s systems. That puts OPM’s Retirement Services center at yet another record high of pending applications — now reaching above 65,000 cases with pensions that are yet-to-be finalized. That’s an 88% increase since OPM’s inventory last October, when retirements from the deferred resignation program first began trickling in.” 
  • The Government Accountability Office posted a report titled “Private Dental and Vision Insurance: Market Concentration Varied Among States.”
    • “As in health insurance markets, people looking for dental or vision insurance may face a concentrated market—i.e., only a few companies to choose from. Consumer choice may also be affected by “vertical integration”—e.g., when a vision insurance company owns the ophthalmologist’s practice and the company that makes glasses frames and lenses.
    • “Dental and vision insurance market concentration varied across states. Little research is available that shows the effects of concentration and vertical integration in these markets. Groups representing dental and vision care insurers, providers, and consumers shared varying opinions on potential effects.”
  • The American Hospital Association New tells us,
    • “March 8-14 marks Patient Safety Awareness Week. The AHA has several resources including podcasts, videos and reports that show how AHA members are advancing patient safety through innovative programs and technologies. LEARN MORE” 
  • Beckers Clinical Leadership adds,
    • “The use of artificial intelligence in diagnosis, rural healthcare access and federal funding cuts are among the most pressing patient safety concerns facing healthcare organizations in 2026, according to a new report from the Emergency Care Research Institute and the Institute for Safe Medication Practices.” * * *
    • “Here are the 10 most pressing patient safety challenges in 2026, per the report:
      • “Navigating the AI diagnostic dilemma
      • “Reduced access to rural healthcare increases health risks and disparities
      • “Increasing rates of preventable acute diseases in communities and healthcare settings 
      • “Effects of federal funding cuts on healthcare operations and patient safety 
      • “Lack of recognition and reporting of harm events
      • “Structural and systemic barriers inhibit equitable pain management for women
      • “Persistent workforce shortages continue to burden staff and restrict access to care 
      • “The impact on system improvement when a culture of blame hinders learning
      • “Emergency department boarding contributes to worse patient outcomes 
      • “Persistent gaps in manufacturer packaging and labeling design continue to undermine medication safety efforts.   

From the Food and Drug Administration front,

  • Fierce Pharma reports,
    • “The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies. 
    • “The newly proposed guidance (PDF) focuses on clinical pharmacokinetic (PK) testing, a core aspect of biosimilar drug testing that serves as a key comparative test to weigh a proposed biosimilar against the approved product it references.
    • “In its draft guidance, the FDA offers recommendations for streamlining unnecessary PK testing when “scientifically justified,” a change that could save biosimilar drugmakers up to 50% of their PK study costs, which equates to about $20 million, the agency said in a press release.
  • and
    • “In a dizzying span of seven months in 2022, Bristol Myers Squibb gained FDA approval for three new products, touting each with the potential to achieve $4 billion in peak sales. 
    • “While multiple myeloma drug Opdualag and cardiomyopathy treatment Camzyos became blockbusters last year, psoriasis med Sotyktu wasn’t close.
    • “With a new FDA nod in hand for Sotyktu, however, BMS can reach more patients with the oral med, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion.
    • “The U.S. regulator has endorsed Sotyktu as a treatment for adults with active psoriatic arthritis. It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication. The thumbs up comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.”

From the judicial front,

  • The AHA News reports,
    • “The U.S. District Court for the Southern District of Florida March 6 ruled in favor of five Florida hospitals in a case challenging the methodology used by the Leapfrog Group regarding hospital safety ratings. In particular, the court determined that Leapfrog’s methodology violated Florida’s unfair and deceptive business practices law. “Leapfrog’s change in methodology has no scientific basis, unfairly penalizes non-participating hospitals, and misrepresents hospital safety,” Judge Donald M. Middlebrooks wrote. The court’s injunction requires Leapfrog to cease assigning safety grades to hospitals, remove grades assigned to the plaintiff hospitals in 2024 and 2025, and issue corrective disclosures, along with other actions.”
  • Per a Justice Department news release,
    • “A Texas man was sentenced Friday to 90 months in prison for his role in a $59.9 million conspiracy to pay kickbacks and submit claims for medically unnecessary durable medical equipment (DME) to Medicare.
    • “According to court documents, Patrick Cassells, 65, of Fulshear, Texas, owned and operated three DME companies and concealed his role in one of those companies by falsely identifying another individual as the sole owner and manager in a Medicare enrollment application. Cassells paid illegal kickbacks to co-conspirators who sent him signed doctors’ orders and other paperwork necessary to bill Medicare for orthotic braces such as knee, back, shoulder and wrist braces. The kickbacks were disguised by referring to the doctors’ orders as “leads” and the services provided as “marketing.” Based on these orders, which were issued without doctors examining or treating the patients, Cassells submitted claims to Medicare that falsely represented that the braces were medically necessary. In total, through the three companies, Cassells caused over $59.9 million in false and fraudulent claims to Medicare, for which Medicare paid over $27 million. Cassells used proceeds of the fraud to purchase personal vehicles and vehicles that he intended to export to Nigeria.
    • “In June 2024, Cassells pleaded guilty in the Southern District of Texas to one count of conspiracy to commit health care fraud.
    • “In addition to the prison sentence, Cassells was ordered to pay $25,402,614.97 in restitution and forfeiture, and to forfeit four vehicles and three properties in the Houston area.”

From the public health and medical / Rx research front,

  • The Hill reports
    • “New data showed childhood obesity has hit a record high in recent years, while federal changes such as cuts to food assistance programs and a revamped food pyramid reignite debates over how to handle the issue.  
    • “A Centers for Disease Control and Prevention (CDC) report late last month showed more than 1 in 5 U.S. children and teenagers were obese between 2021 to 2023, compared to only 5.2 percent between 1971-1974. The number of children with severe obesity in recent years has hit 7 percent.
    • “School meals, physical activity and weight loss drugs have all become talking points in the problem, which is a major issue in the “Make America Healthy Again” movement associated with Health and Human Services Secretary Robert F. Kennedy Jr.
    • “Experts point to school meals and increased activity as key ways to address childhood obesity, with research showing school meals are the healthiest eating options some students have all day.  
    • “They’re noting that this increase in obesity occurred during COVID-19 and that jump in childhood obesity happened during the years when millions of kids lost access to reliable school meals. So, when schools closed for virtual learning, children lost a critical source of daily nutrition,” said Erin Hysom, senior child nutrition policy analyst on the Child Nutrition Programs and Policy team for the Food Research & Action Center.” 
  • The American Medical Association lets us know what doctors wish their patients knew about multiple sclerosis.
  • Brown & Brown released a guide for employers on how to support women’s heart health.
  • MedPage Today tells us,
    • “Infection with Kaposi sarcoma-associated herpesvirus (KSHV) is the cause of Kaposi sarcoma, a type of cancer where lesions grow on the skin and other parts of the body.
    • “This CDC report detailed 46 cases of suspected donor-derived KSHV-related complications among 153 transplant recipients from 2021-2025, roughly five times the number of cases reported from 2016-2020.
    • “Of the 74 transplant recipients identified as having a KSHV infection, 61% developed Kaposi sarcoma.” * * *
    • “A key challenge is the lack of an FDA-approved serology assay to screen for KSHV in donors and recipients. The existing assay for clinical testing is operator-dependent and not easy to scale, Durand noted. A molecular PCR-based assay could theoretically monitor transplant recipients for infection, she added, “but we don’t know who to monitor, how often to monitor, nor what to do with a positive test.”
    • “Despite the challenges, Durand recommended that clinicians keep the KSHV diagnosis in mind, particularly in lung and liver recipients who present with signs and symptoms that might be explained by the virus.”
  • and in better news,
    • “Along with the use of AI, routine screening mammograms could identify women at higher risk of cardiovascular disease, a retrospective cohort study suggested.
    • “A greater amount of AI-calculated breast arterial calcification on imaging was associated with an increased risk of major adverse cardiovascular events.
    • “These findings indicate an opportunity to use routine mammograms for early cardiovascular risk stratification without additional radiation exposure.”
  • Health Day tells us,
    • “Telemedicine has not led to a significant rise in new mental health patients from rural or underserved communities
    • ‘High use of virtual visits led to a 3.6% decrease in the total number of new patients seen by therapists
    • “State licensing laws are likely the barrier to reaching patients across state lines.”
  • Genetic Engineering and BioTechnology News informs us,
    • “Researchers at Washington University School of Medicine in St. Louis have developed genetically altered astrocytes that express chimeric antigen receptors (CARs) as a promising immunotherapy system capable of clearing accumulations of amyloid-β (Aβ)—a hallmark pathological feature of Alzheimer’s disease (AD)—in the brains of mice.
    • “Recently approved anti-Aβ antibody therapies have shown moderate success in slowing AD progression. However, these treatments require large doses, repeated administration, and are associated with potentially serious side effects.
    • “To reduce the frequency of treatment and potentially improve the efficacy of anti-amyloid therapy, scientists headed by Marco Colonna, MD, the Robert Rock Belliveau, MD, professor of pathology at WashU Medicine engineered CAR-expressing astrocytes—CAR-As, as a new type of cellular immunotherapy. Their tests in mice showed that a single injection of the CAR-A treatment prevented amyloid plaques from developing when given before plaques start to form. A single treatment in animals that had already developed plaques also cut the amount of amyloid plaques in half.
    • “This study marks the first successful attempt at engineering astrocytes to specifically target and remove amyloid beta plaques in the brains of mice with Alzheimer’s disease,” said Colonna. “Although more work needs to be done to optimize the approach and address potential side effects, these results open up an exciting new opportunity to develop CAR-astrocytes into an immunotherapy for neurodegenerative diseases and even brain tumors.”
  • STAT News points out,
    • “Xenon Pharmaceuticals said Monday that its treatment for a common type of seizure disorder significantly reduced the frequency of those seizures compared to a placebo — achieving the main goal of a Phase 3 clinical trial. 
    • “The new study results also exceeded the treatment effect reported in the company’s previous mid-stage study. 
    • Xenon said it expects to seek the approval of its drug, called azetukalner, with the Food and Drug Administration in the third quarter. 
    • “In the Phase 3 study, a 25 mg dose of azetukalner reduced the frequency of seizures over a month by 53% compared to 10% in the placebo arm. The difference, just under 43 percentage points, was statistically significant. Participants were treated for 12 weeks.
    • “A 15 mg dose of azetukalner also reduced seizure frequency more than placebo with statistical significance.” 
  • Per BioPharma Dive,
    • “Bristol Myers Squibb said Monday that a regimen including its experimental protein-degrading drug mezigdomide produced positive results in a late-stage trial of patients with relapsed or refractory multiple myeloma.
    • “Investigators found that a combination of mezigdomide and two other standard myeloma therapies was associated with a “statistically significant and clinically meaningful improvement” in progression-free survival when compared to treatment with those two other drugs. Bristol didn’t provide specifics, but said that safety findings were “consistent” with the known profile of mezigdomide and the other components of the regimen.
    • “Mezigdomide is one of several protein-degrading therapies that Bristol Myers acquired in 2019 buyout of Celgene and sees as successors to blood cancer drugs Revlimid and Pomalyst. Another, iberdomide, hit one of its primary goals in a Phase 3 study late last year and is now under review by the Food and Drug Administration.”
  • and
    • “Roche’s experimental drug giredestrant missed the main goal of a Phase 3 trial testing it as an initial treatment for breast cancer, the company said Monday. A combination of the therapy and Pfizer’s Ibrance failed to delay progression or death compared to Ibrance and hormone treatment.
    • “The data is a blow to the Swiss drugmaker’s ambitions for giredestrant, which is already under Food and Drug Administration review in people whose breast cancer has progressed and succeeded in staving off relapses after surgery.
    • “The trial’s failure will also likely reinforce doubts about the commercial potential of drugs in giredestrant’s class, called oral SERDs. The two approved drugs in the class, Menarini’s Orserdu and Eli Lilly’s Inluriyo, have so far only been approved for people whose breast cancer carries a certain mutation.”

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

  • Modern Healthcare announced its Leading Women 2026. Congrats to them.
  • Fierce Healthcare announced its Fierce 15 healthcare companies.
  • BioPharma Dive reports,
    • “Novo Nordisk will begin offering its popular obesity drugs on Hims & Hers’ telehealth platform, ending a messy dispute that resulted in a lawsuit and a crackdown by U.S. drug regulators. 
    • “Under a deal announced Monday, Hims will provide access to Novo’s GLP-1 medicines — the diabetes drug Ozempic and the injectable and pill forms of the weight loss therapy Wegovy — to U.S. consumers at the same prices as other telehealth firms. Hims will no longer promote “compounded” versions of GLP-1 drugs on its website or in advertisements, and will give existing patients the chance to switch to “FDA-approved alternatives,” according to a statement from Novo. 
    • “Novo will, as a result, dismiss its patent infringement lawsuit against Hims while “reserving the right to refile in the future.” News of the deal was first reported by Bloomberg.”
  • Beckers Hospital Review adds,
    • “Amazon Pharmacy has added Eli Lilly’s Zepbound KwikPen in the 2.5-mg starter dose for $299 per month through its cash-pay model.
    • “Zepbound is a multidose injectable medication approved for chronic weight management and, more recently, moderate-to-severe obstructive sleep apnea. With a valid prescription, Amazon customers can order the KwikPen online for home delivery, including same-day delivery in nearly 3,000 cities and towns, according to a March 9 news release. That reach is expected to grow to 4,500 locations by the end of 2026.
    • “Amazon Pharmacy has supplied GLP-1 medications since 2021 and works with partners including LillyDirect, WeightWatchers, UpScriptHealth and Noom. To date, the company said, its platform has saved customers “more than $200 million,” with GLP-1s representing the largest share of savings, according to the release.”
  • and
    • “New York City-based NewYork-Presbyterian is beginning to see early signals from its hospital-at-home program, which launched in November 2025 as health systems across the country continue testing whether acute-level hospital care can be delivered safely in patients’ homes.
    • “The model allows certain patients who would otherwise require inpatient admission to receive hospital-level treatment at home through a combination of in-person nursing visits, remote patient monitoring and virtual physician oversight. Programs like these expanded rapidly during the COVID-19 pandemic under a federal waiver that allowed hospitals to bill Medicare for hospital-at-home services.
    • “Although the waiver was extended until 2030, many health systems are still evaluating whether the care model can deliver consistent outcomes and operational reliability outside traditional hospital walls.
    • “At NewYork-Presbyterian, early data has been encouraging.”
  • Per a Blue Cross news release,
    •  “New research from the Blue Cross Blue Shield Association (BCBSA) and its data analytics partner Blue Health Intelligence® (BHI®) suggests that the growing use of AI in hospital billing is driving higher health care costs by increasing the number and severity of diagnoses billed without any record of the expected treatment.
    • “Analyzing de-identified claims data from tens of thousands of maternity admissions nationwide, researchers found a sharp increase in cases coded for acute posthemorrhagic anemia, a serious condition that typically requires interventions such as blood transfusions. However, many patients coded with the diagnosis never received those treatments.
    • “Something is disconnected,” said Dr. Razia Hashmi, BCBSA’s vice president of Clinical Affairs. “Among hospitals showing the fastest rise in diagnoses of post-partum anemia, the rise in patients coded with this condition wasn’t paired with the level of care we would have expected, and the patterns we’re seeing point to AI‑enabled coding.”
    • “The cost impact is significant, reaching approximately $2.3 billion in spending:
      • “Researchers estimate that roughly $663 million in inpatient spending and at least $1.67 billion in outpatient spending may be tied to more aggressive, AI-enabled coding practices nationwide.”
  • Healthexec shares “four points about healthcare AI that notable experts are emphasizing in the public square.”
  • Per MedTech Dive,
    • “Agilent Technologies said Monday it agreed to acquire Biocare Medical for $950 million in cash to expand its pathology portfolio.
    • “Biocare’s antibody, reagent and instrument business complements Agilent’s offerings in clinical and research pathology and includes immunohistochemistry and in situ hybridization, Agilent said. 
    • “Since 2021, Biocare has generated annual double-digit revenue and profit growth. Revenue exceeded $90 million in 2025. The laboratory instruments and services provider is buying Biocare from an investor group led by Excellere Partners and GHO Capital Partners.”
  • and
    • “Zimmer Biomet shared data on its smart knee implant at the American Academy of Orthopaedic Surgeons conference on Wednesday.
    • “The company found that patients who used its Persona IQ implant with a care management platform had better outcomes a year after surgery than people with a traditional knee implant. 
    • “Mike Anderson, Zimmer’s clinical strategy associate director, said the results of the analysis showed that the company’s technology was associated with lower rates of revision surgery and periprosthetic joint infection, less use of opioids, and fewer visits to urgent care and physical therapy.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iran War front,

  • Security Week reports,
    • “The Iranian APT MuddyWater has hacked into the networks of several organizations in the US, including an aerospace and defense contractor, Broadcom’s Symantec and Carbon Black threat hunting team reports.
    • “The threat actor has been present in the environments of an airport, a bank, a non-governmental organization operating in the US and Canada, and a software company with a presence in Israel.
    • “According to the Broadcom experts, the APT’s activity has continued “in recent days following US and Israeli military strikes on Iran that have sparked conflict in the region”.
  • Cybersecurity Dive adds,
    • “Pro-Russia threat actors have formed a loose coalition with Iran-nexus hacking groups in response to the bombing campaign launched by the U.S. and Israel on Iran. 
    • “The groups began working together Monday under the #OpIsrael campaign, with a focus on targeting critical infrastructure and exfiltration of data, according to researchers at Flashpoint.” * * *
    • “Researchers at Palo Alto Networks Unit 42 estimate that about 60 threat actors, including Iran-nexus and Russia-aligned groups, might be involved in various levels of hacking activity since the bombing campaign began.”  
  • The American Hospital Association News tells us,
    • “The FBI is reminding critical infrastructure organizations to implement mitigations from a June 2025 fact sheet on potential actions by Iranian-affiliated cyber actors who may target U.S. devices and networks due to geopolitical tensions. The fact sheet explains how cyber actors often exploit targets with unpatched or outdated software with known common vulnerabilities or passwords.  
    • “In the context of the ongoing conflict with Iran, it is particularly important to ensure that we are implementing cybersecurity measures to defend against the known tactics used by Iranian state-sponsored hackers or pro-Iranian hackers acting independently,” said John Riggi, AHA national advisor for cybersecurity and risk. “Besides seeking to exploit common vulnerabilities and default passwords, they also target internet-connected operational technology and industrial control systems. These systems may be present in hospitals in the form of HVAC, water, life-safety and building automation systems. It is recommended that cyber teams closely coordinate with facilities and building engineers to identify internet-facing OT and ICS systems, assess the need for internet connectivity and ensure they are patched and secure.”

From the cybersecurity policy and law enforcement front,

  • The Wall Street Journal reports,
    • “The Trump administration published its new cyber strategy Friday [March 6], framing digital security in the context of broader geopolitical issues and promising to incentivize the private sector to identify and disrupt cyber adversaries.
    • “Compared with the Biden administration’s 2023 National Cybersecurity Strategy, which ran more than 35 pages and detailed dozens of policy initiatives, the new document is far shorter at five pages and sets out broad principles for future policy decisions and priorities.”
  • Cyberscoop adds,
    • “The strategy “calls for unprecedented coordination across government and the private sector to invest in the best technologies and continue world-class innovation, and to make the most of America’s cyber capabilities for both offensive and defensive missions,” the White House said in a statement accompanying its release.”
    • “Trump also signed an executive order Friday directing agencies to take action to combat cybercrime and fraud.”
  • The Congress did not resolve the Department of Homeland Security shutdown this week.
  • Fedscoop reports,
    • “The Department of Homeland Security is undergoing an overhaul of its IT and information security leadership, with multiple sources telling FedScoop there is a broad realignment underway at the department to replace key technology leaders.
    • “FedScoop has learned that at least two DHS officials are being replaced: Chief Information Security Officer Hemant Baidwan and Deputy CISO Amanda Day. 
    • “The reorg among IT officials comes as other leadership is changing at the department. President Donald Trump announced Thursday that Secretary of Homeland Security Kristi Noem will be leaving the position at the end of March. Trump has nominated Sen. Markwayne Mullin, R-Okla, as her replacement.
  • Cybersecurity Dive adds,
    • “The confirmation prospects for Sean Plankey, President Donald Trump’s nominee to lead the Cybersecurity and Infrastructure Security Agency, have dimmed further following Plankey’s unceremonious departure from a job at the Department of Homeland Security.
    • “Security personnel escorted Plankey out of a DHS facility on Monday, a person familiar with the matter told Cybersecurity Dive, confirming an incident first reported by CBS News. Plankey announced on Wednesday that he had left his job as a senior Coast Guard adviser to DHS Secretary Kristi Noem, but he framed his departure as a voluntary one intended to help him focus on his nomination to serve as CISA director.”
  •  Per an HHS news release,
    • “Today [March 5], the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced a settlement with MMG Fusion, LLC (MMG), a Maryland software company, concerning potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules. MMG is a business associate as it receives protected health information (PHI) from HIPAA covered entities and its software is used to communicate directly with patients of covered entities.” * * *
    • “The settlement resolves an investigation that OCR initiated in March 2023 after receiving a complaint concerning an unreported security incident at MMG, and the posting of PHI on the dark web. OCR’s investigation determined that in December 2020, an unauthorized actor infiltrated MMG’s information system and accessed PHI [of 15 million people], including names, phone numbers, mailing addresses, email addresses, dates of birth, and dates and times of medical appointments.” * * *
    • “The resolution agreement and corrective action plan may be found at https://www.hhs.gov/sites/default/files/ocr-mmg-fusion-hipaa-agreement.pdf [PDF, 264 KB].”
  • Cybersecurity Dive informs us,
    • “An international coalition led by Microsoft and Europol has taken down the operations of Tycoon 2FA, a notorious phishing-as-a-service platform that helped cyber criminals gain access to millions of email accounts across the globe. 
    • “Microsoft obtained a court order from the U.S. District Court from the Southern District of New York to seize 330 active domains used to back the core infrastructure of Tycoon 2FA.
    • “Taking this infrastructure offline cuts off a major pipeline for account takeovers and helps protect people and organizations from follow-on attacks such a data theft, ransomware, business email compromise and financial fraud,” Steve Masada, assistant general counsel at Microsoft’s Digital Crimes Unit, said in a blog post published Wednesday.” 
  • Bleeping Computer lets us know,
    • “The FBI has seized the LeakBase cybercrime forum, a major online forum used by cybercriminals buy and sell hacking tools and stolen data.
    • This seizure action is part of an international joint operation coordinated by Europol, known as “Operation Leak,” that involved law enforcement agencies in 14 countries.
    • On March 3 and 4, the FBI and law enforcement agents shut down LeakBase by seizing two of its domains, posting seizure banners, and warning LeakBase members of the seizure after collecting further evidence.” * * *
    • Today’s [March 4] announcement follows the disruption of RaidForums in 2022 and BreachForums in 2023, two cybercrime marketplaces that preceded it, as well as the BreachForums founder’s conviction and sentencing in 2025.
  • and
    • “A U.S. government contractor’s son, accused of stealing more than $46 million in cryptocurrency from the U.S. Marshals Service, was arrested Wednesday on the island of Saint Martin.
    • “The arrest was the result of a joint operation between the FBI and France’s elite Groupe d’Intervention de la Gendarmerie Nationale, FBI Director Kash Patel announced on Thursday.
    • “Last night, John Daghita – a U.S. government contractor who allegedly stole more than $46 million in cryptocurrency from the U.S Marshals Service – was arrested on the island of Saint Martin by the French Gendarmerie’s premier elite tactical unit in a joint operation with the @FBI,” Patel said.”
  • Cyberscoop points out,
    • “Russian national Evgenii Ptitsyn pleaded guilty to running the Phobos ransomware outfit that extorted more than $39 million from more than 1,000 victims globally, the Justice Department said Wednesday.
    • “Ptitsyn assumed a leadership role in the Phobos ransomware group in January 2022, yet his criminal activities began by April 2019, according to court records. He continued leading the cybercrime syndicate until May 2024 when he was arrested in South Korea. Ptitsyn was extradited to the United States in November 2025.
    • “Federal prosecutors dropped multiple charges against Ptitsyn as part of a plea agreement he signed last month. He faces up to 20 years in prison for wire fraud conspiracy.
    • “Ptitsyn agreed to forfeit $1.77 million in assets and is required to pay at least $39.3 million in restitution, representing the full amount of his victims’ losses.

From the cybersecurity breaches and vulnerabilities front,

  • The Wall Street Journal reports on March 6,
    • “U.S. investigators believe hackers affiliated with the Chinese government are responsible for a cyber intrusion on an internal Federal Bureau of Investigation computer network that holds information related to some domestic surveillance orders, according to people familiar with the matter.
    • “The scope and severity of the intrusion aren’t known, and the investigation is in its early stages, the people said. Any preliminary conclusions could change as investigators gather more information. 
    • “If China is confirmed to be responsible for the breach, it would signal the latest intrusion by Beijing’s hackers of computer systems related to law-enforcement surveillance orders, which contain highly sensitive material.
    • “A notification sent in recent days to some lawmakers in Congress said the FBI began investigating the matter last month, the people said. The intrusion involved hackers accessing an unclassified system that contains information about the calls and internet activity of criminal suspects and others under government surveillance. Information in the system includes incoming and outgoing calls, IP and website addresses and some routing information, but doesn’t include the contents of calls or digital communication.” 
  • Cybersecurity Dive adds,
    • “A total of 90 zero-day vulnerabilities were exploited in the wild in 2025, according to a report released Thursday by Google Threat Intelligence Group.
    • “Of that total, almost half of the exploited vulnerabilities were used against enterprise-grade technology, marking an all-time high. 
    • “Exploitation from state-sponsored groups targeted networking and security tools with a strong emphasis on edge devices, which often lack endpoint detection and response capabilities, according to GTIG researchers. 
    • “China-nexus groups remain the most prolific state-sponsored groups, with a long history of detailed knowledge of vulnerable devices. 
    • “They have a significant zero-day development ecosystem that includes industry, academia, and government,” John Hultquist, chief analyst at GTIG, told Cybersecurity Dive.”
  • Bleeping Computer relates,
    • “TriZetto Provider Solutions, a healthcare IT company that develops software and services used by health insurers and healthcare providers, has suffered a data breach that exposed the sensitive information of over 3.4 million people.
    • “The firm, which has been operating under the Cognizant umbrella since 2014, disclosed that it detected suspicious activity on a web portal on October 2, 2025, and launched an investigation with the help of external cybersecurity experts.
    • “The investigation revealed that unauthorized access began nearly a year before, on November 19, 2024.’ * * *
    • “Affected providers were alerted on December 9, 2025, but customer notification started in early February 2026. According to a filing Maine’s Attorney General submitted today [March 6], the number of exposed individuals is 3,433,965.
    • “TriZetto says that payment card, bank account, or other financial information was not exposed in this incident. Also, the company is not aware of any cases where cybercriminals have attempted to misuse this information.”
  • CISA added seven known exploited vulnerabilities to its catalog this week.
    • March 3, 2026
      • CVE-2026-21385 Qualcomm Multiple Chipsets Memory Corruption Vulnerability
      • CVE-2026-22719 Broadcom VMware Aria Operations Command Injection Vulnerability
        • Cybersecurity News discusses the Qualcomm KVE here.
        • Bleeping Computer discusses the VM Aria KVE here.
    • March 5, 2026
      • CVE-2017-7921 Hikvision Multiple Products Improper Authentication Vulnerability
      • CVE-2021-22681 Rockwell Multiple Products Insufficient Protected Credentials Vulnerability
      • CVE-2021-30952 Apple Multiple Products Integer Overflow or Wraparound Vulnerability
      • CVE-2023-41974 Apple iOS and iPadOS Use-After-Free Vulnerability
      • CVE-2023-43000 Apple Multiple products Use-After-Free Vulnerability
        • The Hacker News discusses the Hikvision and Rockwell KVEs here.
        • Bleeping Computer discusses the Apple KVEs here.
  • Cyberscoop adds,
    • “Cisco released information on a pair of max-severity vulnerabilities in its firewall management software Wednesday that unauthenticated, remote attackers could exploit to obtain the highest level of access to the underlying operating system or on affected devices.
    • “The vulnerabilities — CVE-2026-20079 and CVE-2026-20131 — affect the web-based interface of Cisco Secure Firewall Management Center (FMC) Software, regardless of device configuration, the vendor said.
    • “Cisco disclosed the critical vulnerabilities one week after it warned that attackers have been exploiting a pair of zero-days in Cisco’s network edge software for at least three years. That campaign, which is ongoing, marked the second series of multiple actively exploited zero-days in Cisco edge technology since last spring. 
    • “Both campaigns prompted the Cybersecurity and Infrastructure Security Agency to issue emergency directives months after the attacks were first detected, and both attack sprees were underway for at least a year before they were discovered.” 
  • and
    • “Google disclosed one actively exploited zero-day vulnerability Monday, warning that the high-severity defect affecting an open-source Qualcomm display component for Android devices “may be under limited, targeted exploitation.”
    • “The memory-corruption vulnerability — CVE-2026-21385 — which Google’s Androidsecurity team reported to Qualcomm Dec. 18, affects 234 chipsets, Qualcomm said in a security bulletin. Qualcomm said it notified customers of the vulnerability Feb. 2.
    • “Qualcomm declined to say when the earliest known instance of exploitation occurred, how many victims have been directly impacted, and what occurred during the 10-week period between the reporting and public disclosure of the vulnerability. 
    • “We commend the researchers from Google’s Threat Analysis Group for using coordinated disclosure practices,” a Qualcomm spokesperson told CyberScoop. “Fixes were made available to our customers in January 2026. We encourage end users to apply security updates as they become available from device makers.”
  • and
    • “North Korean threat groups are using artificial intelligence tools to accelerate and expand the country’s long-running scheme to get remote technical workers hired at global companies for longer durations, Microsoft Threat Intelligence said in a report Friday. 
    • “AI services are empowering North Korean operatives across the attack lifecycle. Attackers have turned AI into a “force multiplier” that bolsters and automates their efforts to conduct research on targets, develop malicious resources, achieve and maintain access, evade detection, and weaponize tools for attacks and post-compromise activities, researchers said.
    • “Microsoft said a trio of groups it tracks as Coral Sleet, Sapphire Sleet and Jasper Sleet are using AI to shorten the time it takes to create digital personas for specific job markets and roles. These groups frequently leverage financial opportunities or interview-themed lures to gain initial access.”
  • The Hacker News notes,
    • “Cybersecurity researchers have disclosed details of a new phishing suite called Starkiller that proxies legitimate login pages to bypass multi-factor authentication (MFA) protections.
    • “It’s advertised as a cybercrime platform by a threat group calling itself Jinkusu, granting customers access to a dashboard that lets them select a brand to impersonate or enter a brand’s real URL. It also lets users choose custom keywords like “login,” “verify,” “security,” or “account,” and integrates URL shorteners such as TinyURL to obscure the destination URL.
    • “It launches a headless Chrome instance – a browser that operates without a visible window – inside a Docker container, loads the brand’s real website, and acts as a reverse proxy between the target and the legitimate site,” Abnormal researchers Callie Baron and Piotr Wojtyla said.”

From the ransomware front,

  • The Record reports,
    • “The University of Hawaiʻi Cancer Center said up to 1.2 million people had information leaked as a result of a ransomware attack on its epidemiology division last year. 
    • “Hackers accessed records containing Social Security numbers (SSNs) and driver’s license numbers collected from the Hawaiʻi State Department of Transportation as well as City and County of Honolulu voter registration records from 1998, according to a statement released by the organization last week.” * * *
    • “In January, the university sent a report to the state legislature that said the cyber incident was first discovered on August 31, 2025.” * * *
    • “Naoto Ueno, director of the University of Hawaiʻi Cancer Center, apologized for the incident last week and said the organization was “committed to transparency.” 
    • “The university said the attackers encrypted and likely exfiltrated data, prompting them to notify law enforcement and hire cybersecurity experts to resolve the situation. The cybersecurity firm obtained a decryption tool and secured “an affirmation that any information obtained was destroyed.”  
    • “University officials claimed there is “no evidence that any of the information has been published, shared or misused.” The group responsible for the attack was not identified.”   
  • Cybersecurity Dive relates,
    • “Identity has replaced malware as the biggest threat vector opening the door for ransomware attacks, Cloudflare said in an annual threat report published on Tuesday.
    • “Hackers’ increasing use of legitimate credentials, rather than malicious code, is making it harder for defenders to detect and contain their attacks.
    • “Cloudflare’s new report also discussed nation-state threat actors’ behavior and how artificial intelligence is changing attacks.”
  • Mobihealth News interviews Scott Doerr, virtual CISO, or vCISO, at Fortified Health Security, [who] previews his upcoming talk at the 2026 HIMSS Global Health Conference & Exposition, where he will discuss how healthcare companies can strengthen their preparedness for ransomware attacks. 

From the cybersecurity business and defenses front,

  • Cyberscoop reports,
    • “CrowdStrike Holdings reported record earnings in the fiscal fourth-quarter, defying investor concerns about the rising use of agentic AI potentially curbing demand for cybersecurity software and services. 
    • “The Texas-based cybersecurity company said total revenue grew 23% on a year-over-year basis, to $1.31 billion in the quarter ended Jan. 31. 
    • “Annual recurring revenue, a closely watched metric among cybersecurity companies, grew 24%, to $5.25 billion. 
    • “The results come at a time of growing market anxiety about how AI adoption could render traditional software — including cybersecurity tools — obsolete. CrowdStrike executives acknowledged those larger industry concerns and noted the Q4 performance was a demonstration that certain companies were well-positioned to compete in the new marketplace.” 
  • ZDNet adds,
    • “Anthropic, OpenAI, and Google tools can automate code debugging. 
    • “But cybersecurity is too complex a problem for these tools to solve. 
    • “AI’s biggest contribution may be to reduce avoidable software flaws. 
  • Healthexec relates,
    • “In January, National Security Agency (NSA), released protocols for the U.S. Department of War to achieve “zero trust” security across the agency, meaning any access to the network must come from something continually inside it. While such a setup would be technically demanding for healthcare, the American Hospital Association (AHA) said it may be time for facilities to start moving in that direction.
    • “Zero trust security would mean radical changes for hospitals, where a countless number of devices have access to networks, including everything from EHRs to medical devices, to tablets and smartphones used for communication.
    • “What the NSA wants the Department of War to adopt is a system where no one gains access to a network from the outside, meaning no logins or passwords. In fact, even systems connected to the network from the inside are not automatically trusted.
    • “In other words, every user, device, and system must continually prove they are allowed access—and access is limited strictly to what’s necessary.
    • “The ethos of zero trust means that it’s assumed even the network itself isn’t safe, hence the continuous verification. Something like a two-factor authentication app displaying a constant active code would be required to log on.”
  • The AHA News adds,
  • SC World tells us,
    • “The 2026 Zero Trust World conference kicked off here Wednesday (March 4) with a particularly optimistic keynote by futurist and TV host Jason Silva and also featured a last-minute addition in the form of a talk by former White House CIO Theresa Payton.
    • “But it was the smaller sessions, including a dark-web primer and a live Security Now! podcast broadcast featuring cybersecurity veterans Steve Gibson and Leo LaPorte, that stole the show during the first day of ThreatLocker’s annual user conference.”
  • Tech Target explains “how to perform a data risk assessment, step by step.”
  • Here’s a link to Dark Reading’s CISO Corner.

Thursday report

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

From Washington, DC

  • The House of Representatives today passed the Department of Homeland Security Appropriations Act, 2026 (HR 7744) by a 221 to 209 vote. The Senate , however, failed to invoke cloture on a similar bill (HR 7147) by a 51-45 vote (60 votes required), meaning the ongoing DHS shutdown will continue.
  • Per a Senate news release,
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, delivered remarks during today’s hearing on how the U.S. Office of National Coordinator for Health Information Technology (ONC) is improving health outcomes using patient health information.
    • “Click here to watch the full hearing.”
  • Govexec reports,
    • “The Trump administration will continue working to shrink the size of the federal workforce after already shedding more than 300,000 employees, a White House official said on Thursday, who suggested a leaner civil service will be more effective as a result of its reduced stability. 
    • “Continuing to reduce the size of the federal government and its workforce remains “priority number one,” Office of Management and Budget Deputy Director for Management Eric Ueland said at a government efficiency conference in Washington, adding it would contribute to the goal of tackling waste, fraud and abuse. He pledged that individual agencies would ensure consistent and transparent communication on their plans, so employees would at least have a clear roadmap of what is to come even if they disagree with the destination.” * * *
    • “Scott Kupor, the Office of Personnel Management [OPM] Director who also spoke at the panel, said his agency is not giving agencies any specific targets for workforce reduction.” * * *
    • “He added the needs of government will continue to grow, but agencies must find ways to add to their portfolios without adding staff.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced the launch of the Attorney Talent Network.
    • “The Attorney Talent Network enables attorneys from across the United States to connect directly with federal recruiters and explore career opportunities in the federal government. By joining the network, attorneys can make their resumes searchable, receive notifications about job openings, and be alerted to upcoming hiring events.” * * *
    • “Attorneys interested in joining can create or log in to their USAJOBS account, upload their resume, and opt in to share their profile with federal recruiters through the here.
    • “For more information or to join the Attorney Talent Network, click here.”
  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services and Education March 5 announced a new initiative to increase nutrition education in medical schools beginning this fall for the next academic year. The agencies announced commitments from 53 schools for the program, which will provide at least 40 hours of nutrition education or a 40-hour competency equivalent for medical students. HHS also announced $5 million in funding for a multi-phase education challenge by the National Institutes of Health to support medical schools, nursing residency, nutrition science and dietitian programs that integrate nutrition education into their curricula. Additionally, HHS said that Public Health Service officers will be required to complete nutrition-focused continuing education hours as part of their career development.”
  • Newfront offers RxDC reporting considerations for 2026 filings.
  • Per an AHIP news release,
    • “A new national survey finds American workers hold consistently positive views of employer-provided health care coverage, with nearly nine in 10 expressing satisfaction with their plans and strong majorities valuing the financial security and peace of mind their coverage provides.
    • “Employer-provided coverage is the backbone of our nation’s health care system, delivering high-quality, affordable health care and financial security to more than 180 million Americans. These findings confirm once again that Americans strongly value their employer-provided health coverage and want policymakers to support the longstanding partnership between employers and health plans,” said AHIP president and CEO Mike Tuffin.
  • Modern Healthcare points out,
    • “A health insurance industry-backed coalition is going after hospitals in a bid to capitalize on Washington’s bipartisan focus on affordability and rising healthcare costs.
    • “Better Solutions for Healthcare launched its “Hospital Watch” campaign last month. The organization’s website links to news articles and data that are unflattering to the hospital sector. A banner on the home page reads, “Shining a Light on Corporate Hospital Systems’ Role in Driving America’s Healthcare Cost Crisis.”
    • “The effort could prove well-timed. Over the past few years, Congress has focused on drug prices and pharmacy benefit managers — as has President Donald Trump — and on health insurance premiums and industry practices. Their attention may be shifting to providers.”

From the Food and Drug Administration front,

  • The Wall Street Journal lets us know,
    • “Federal health officials, facing criticism from lawmakers for recent rejections of rare-disease drugs, attacked an Amsterdam-based biotech company seeking approval of a Huntington’s disease treatment and accused it of lying.
    • “The public criticism of Uniqure by officials at the Food and Drug Administration and Health and Human Services department was unusual for agencies that normally shy away from commenting on products still under consideration.
    • “The attacks risk further angering members of Congress who have been pressing the Trump administration to be more open to approving rare-disease therapies, after FDA officials rejected or delayed some applications for approval of some new drugs.”
  • STAT News explains,
    • “Is it better to approve a drug with undetermined or debatable benefits that is later found not to be effective?
    • “Or, is it better to reject or block a drug with undetermined or debatable benefits that is later found to be effective?
    • “These are two fundamentally different regulatory philosophies. Peter Marks, the former FDA regulator of cell and gene therapies, was firmly in the “approve now” camp. He believed in maximal flexibility, one might even call it absolute permissiveness.
    • “If there was a chance a treatment could help a patient with a rare disease, even if the data were equivocal, Marks was willing to approve it. Rejecting that drug and later learning that it was effective is a far worse outcome, in Marks’ view.
    • “Vinay Prasad, Marks’ successor at the FDA, takes a maximalist approach in the other direction. He wants to approve drugs that work with certainty. The regulatory bar is high.
    • “Uncertainty — anything outside the statistical fence — is a disqualifier. For Prasad, approving a drug without proven benefit is false hope. Approving a drug that later ends up being ineffective is the worst outcome.
    • “Two regulators, two extreme regulatory philosophies, one replacing the other.
    • “The rare disease community is suffering whiplash. Drugmakers are frustrated. Investors are sitting on their wallets.”
  • Fierce Pharma reports,
    • “Since discontinuing its two branded versions of asthma inhaler Flovent at the start of 2024, GSK has still produced “authorized generic” versions of the treatment, which are the same products with different labels distributed by another firm.
    • “Now, true competition has finally arrived for GSK’s Flovent in the form of an FDA approval for Glenmark’s fluticasone propionate inhalation aerosol. The inhaled corticosteroid, which reduces inflammation in the lungs, is a maintenance treatment and can be used by patients ages 4 and older to prevent wheezing and shortness of breath.
    • “As the first company to gain FDA approval for a Flovent generic, Glenmark receives 180 days of exclusivity before other makers of generics can enter the market. Glenmark will begin distributing fluticasone this month, the company said in a release.”
  • Radiology Business reports,
    • “The U.S. Food and Drug Administration has approved the first artificial intelligence-powered imaging device for breast cancer surgery. 
    • “Manufacturer Perimeter Medical Imaging announced the news on Tuesday after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). The product also has received Breakthrough Device designation, with it designed to enhance surgeon’s ability to detect difficult-to-see cancers during surgery. 
    • “This could potentially reduce the need for repeat operations and save excess healthcare costs, the company contends. 
    • “Repeat breast cancer surgeries due to residual disease remain a significant clinical, health and economic burden,” Perimeter CEO Adrian Mendes said in a statement March 3. “Claire’s FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told ‘we didn’t get it all.’”
    • “Mendes said the Dallas-based company plans to roll out the product nationwide in the coming weeks. Claire combines proprietary AI with wide-field OCT imaging, enabling high-res, real-time evaluation of excised tumor margins. The system purportedly can deliver 10 times higher resolution when compared to standard X-ray and ultrasound.” 
  • BioPharma Dive adds,
    • “PepGen is in a holding pattern on its request to include U.S. patients in a Phase 2 trial of a muscle disorder treatment after the Food and Drug Administration put a partial halt on the study.
    • “The agency did not raise any questions about the company’s data in patients with the condition known as myotonic dystrophy type 1, or DM1, instead focusing on previously submitted preclinical work, PepGen said Wednesday. Specifically, the FDA seems concerned about drops in blood pressure in a study of mice that have not been seen in humans, analysts wrote.
    • “PepGen said it’s working with the FDA to address the concerns as quickly as possible. The company is continuing its Phase 2 work elsewhere and recently got permission to open the “Freedom2” studyto patients in New Zealand, Australia and South Korea.” 

From the judicial front,

  • Per a Justice Department news release,
    • “Brad D. Schimel, United States Attorney for the Eastern District of Wisconsin, announced today that Kinex Medical Company, LLC, agreed to pay $6,925,000 to resolve allegations that it violated the False Claims Act by submitting false claims to Medicare, TRICARE, and other federal programs.
    • “Based in Waukesha, Wisconsin, Kinex sells and distributes durable medical equipment, including knee, shoulder, and hip braces, to patients across the United States. After receiving information from a whistleblower, the United States investigated and alleged that the company submitted false claims to Medicare, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Office of Workers Compensation Programs of the Department of Labor (OWCP). 
    • “Specifically, the United States alleged that from 2019 through 2024, Kinex provided patients covered by these programs with medical braces that the patients did not need and then billed Medicare, TRICARE, FEHBP, and OWCP as if the braces had been necessary. The United States also alleged that Kinex convinced the patients to accept the braces by waiving costs like patient co-pays and by giving the patients other equipment for free.
    • “In addition to paying nearly $7 million to resolve the allegations concerning these false claims, Kinex also entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General (HHS-OIG), to ensure compliance with applicable regulations going forward.”
  • Fierce Healthcare relates,
    • “The Federal Trade Commission (FTC) may be nearing settlements with the remaining two pharmacy benefit managers involved in a lawsuit over insulin pricing.
    • “In a court filing (PDF) posted this week, the agency disclosed that it is making “significant progress” in talks with both CVS Health’s Caremark and UnitedHealth Group’s Optum Rx on the heels of a broad settlement with Cigna’s Express Scripts.
    • “In late January, the FTC suspended the administrative case against Express Scripts, indicating a settlement was in the works. That settlement was later confirmed Feb. 4, with the PBM agreeing to a slew of changes to resolve allegations that it unlawfully and artificially inflated the price of insulin.
    • “In the filing, the agency pushed back the date for an evidentiary hearing and oral arguments in the case by 21 days, to late March, to allow for greater negotiation time.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “Initiation of a GLP-1 receptor agonist was tied to lower risks of several substance use disorders (SUDs) in adults with type 2 diabetes, according to a target trial emulation using data on veterans.
    • “In patients without a history of any SUD, those who started a GLP-1 drug versus an SGLT2 inhibitor had a reduced risk of a composite outcome of all SUDs, including alcohol, cannabis, cocaine, nicotine, opioid, and other SUDs (HR 0.86, 95% CI 0.83-0.88), reported Ziyad Al-Aly, MD, of the VA Saint Louis Health Care System, and colleagues.
    • “Benefits also extended to those with pre-existing SUDs, the researchers wrote in The BMJ.” 
  • The AAMC shares information about
    • GLP-1 pills for weight loss are here. How will they change obesity care?
  • and
    • What you need to know about the updated childhood vaccination schedule.
  • Cardiovascular Business informs us,
    • “A new implantable artificial intelligence (AI) device that modulates venous pressure to increase renal perfusion in diuretic-resistant heart failure patients was associated with positive 90-day data in the first-in-human RELIEF-FIH study. Researchers presented the data at the THT 2026 conference in Boston.
    • “The Relief System from Relief Cardiovascular is a first-of-its-kind device. The goal of the device is to better manage heart failure congestion at home. It is one of many new heart failure technologies aimed at finding new ways to reduce heart failure rehospitalizations, which are a major driver for healthcare costs.
    • “The Relief System incorporates a valve and sensor implant that uses AI to intelligently modulate venous pressure using hemodynamic data. The system actively adjusts flow in the inferior vena cava (IVC), which lowers venous pressure to drive durable decongestion in heart failure. It uses a daily transmission of hemodynamic data to adjust the valve through a cloud-enabled interface.”

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

  • Beckers Payer Issues reports,
    • “Excellus BlueCross BlueShield ended 2025 with a 1.4% operating loss totaling $108 million, as medical and drug claims climbed 16% year over year to nearly $7 billion. The insurer said March 5 the results are its largest annual claims increase in nearly 20 years.
    • “Last year, Excellus spent roughly $19 million daily on medical and drug benefits for its 1.5 million members. The company’s 2025 medical loss ratio was 92%, and it recorded a 2% net margin and $150 million in net income. Reserves closed the year at $1.7 billion, which is equal to less than three months of claims and operating expenses.
    • “Medicare Advantage drove most of the cost increase.”
  • and
    • “Three of four Regence health plans ended 2025 with operating losses as medical and drug costs climbed across Oregon, Washington, Idaho and Utah, according to results published by the organizations on March 2.
    • “The Washington plan was the hardest hit. Regence BlueShield reported an operating loss of nearly 8% on total revenue of $2.38 billion and a net loss of 3.1%. The plan paid $2.17 billion in care for its fully insured members, with per-member costs rising more than 15% year over year. Total membership at the end of 2025 was 1.58 million.
    • “In Oregon, Regence BCBS posted a 1.3% operating loss on revenue of $3.18 billion, though investment returns pushed the plan to 1.5% net income. The plan paid $2.9 billion in care for fully insured members, at $6,022 per member, up 15% from 2024. Total membership was roughly 950,000 at the end of 2025.
    • ‘Regence BlueShield of Idaho also ran an operating loss, at 0.5% on revenue of $752 million, but finished with net income of 2.5% because of the strength of investment returns. Per-member costs rose more than 22%, the steepest increase among the four plans. The plan had more than 350,000 members at year’s end.
    • “Regence BCBS of Utah reported net income of 3.5% on total revenue of $1.45 billion, slightly above its 10-year average of 3%, driven by strong member retention and investment income. The plan paid $1.31 billion in care for fully insured members, with per-member costs rising nearly 5%. Membership held at roughly 740,000.”
  • The Commonwealth Fund tells us,
    • “Changing how we pay for primary care can incentivize clinicians to deliver the right care at the right time. Historically, clinicians have been retroactively paid a fee for each service they provide. Known as fee-for-service (FFS), this practice encourages clinicians to provide more services, rather than efficiently deliver comprehensive care. Although it can lead to more care, it may not lead to better health outcomes.
    • “Instead, we could use payment to encourage primary care clinicians to deliver appropriate, efficient care in coordination with other clinicians. An increasingly common way to do this — value-based payment (VBP) — ties clinicians’ payments to their performance on outcomes, including the cost and quality of care. Specific outcomes include the way clinicians manage patients’ chronic conditions or the minimization of avoidable hospitalizations. The evidence shows that changing how we pay for primary can improve patients’ outcomes, including reducing avoidable hospitalizationsand increasing access to coordinated care.
    • “Despite the promise of VBP, some primary care practices have been left behind, and their patients haven’t been able to benefit. Policymakers and payers are particularly worried about low participation among rural, small, and independent practices, as well as community health centers (CHCs) that face unique barriers to participation.
    • “In this blog post, we assess current rates of primary care physician (PCP) participation in VBP, using data from the 2025 Commonwealth Fund International Health Policy Survey of Primary Care Physicians. We also highlight opportunities to design value-based models to account for the needs of different practice settings, such as small or rural practices.”
  • STATNews relates,
    • “Digital chronic care company Omada reported a quarterly profit for the first time since going  public less than a year ago, the company revealed while announcing  its full year 2025 earnings Thursday. 
    • “Omada also provided earnings guidance for 2026, suggesting the company will continue to grow as it capitalizes on the demand for popular GLP-1 obesity medications.
    • ‘Omada earned $260 million in revenue in 2025, 53% more than the year before — above top-end preliminary results the company announced at the J.P. Morgan Healthcare Conference in January. In August, shortly after it went public, it projected top-end earnings of $241 million for the year.
    • “Notably, the company reported $5 million in net income in the fourth quarter of 2025 — the first time the company has turned a net profit. 
    • “We’re pretty ahead of schedule on a lot of positive financials,” Omada CEO Sean Duffy told STAT.”
  • Modern Healthcare tells us,
    • “CVS Health plans to launch a health technology subsidiary later this year that will offer an artificial intelligence-based platform designed to help consumers access healthcare information and services. 
    • “The platform will allow patients to find providers, compare costs of care and centralize their health records and information, CVS said. It also will make recommendations for the next steps of care for patients with chronic conditions and offer care management through a digital health portal between visits.
    • “The Health100 consumer platform, slated to launch midyear, will use agentic AI and be powered by Google Cloud technology, including Gemini AI programs.
    • “It will be rolled out first to CVS Health customers and not all features will be available upon launch, a spokesperson said. It will be expanded to other consumers, and outside providers and other companies can opt in to participate, the spokesperson said.”
  • Healthcare Dive adds,
    • “Amazon Web Services rolled out a suite of agentic artificial intelligence tools Thursday that aim to handle a range of healthcare tasks, like helping patients schedule appointments and summarizing medical data for clinicians. The product, called Amazon Connect Health, includes five capabilities: verifying patients’ identities; handling appointment scheduling; creating summaries of patient medical histories; creating clinical notes based on conversations between clinicians and patients; and generating medical codes from clinical documentation. 
    • “Amazon Connect Health should help patients more easily access care and assist with clinicians’ administrative work, according to Naji Shafi, general manager and director of healthcare AI at AWS. “Our healthcare workers are overburdened, drowning in administrative complexity, and it’s costing everyone,” he said.” 
  • Per Beckers Health IT,
    • “Optum is expanding its collaboration with Microsoft to introduce new AI-powered capabilities within Optum Real, a real-time claims platform designed to connect payers and providers and streamline reimbursement workflows.
    • “In a March 5 news release, the companies said the new capabilities combine Optum’s healthcare data and analytics expertise with Microsoft technologies including Azure, Dragon Copilot and Microsoft Foundry. The platform aims to give providers a unified view of clinical and operational data while helping teams identify coverage issues, automate documentation tasks and address prior authorization requirements earlier in the care process.”
  • Fierce Healthcare informs us,
    • “Eli Lilly has officially launched Employer Connect, its direct-to-employer platform for its obesity medications, after teasing the rollout late last year.
    • “The drugmaker said in an announcement that the program is aimed at supporting employer choice and enabling them to build the solution that works best for them and their workforces. It will launch with more than 15 independent program administrators as partners, which allows employers to select multiple models.
    • “Coverage for GLP-1s remains a key challenge for employers to navigate, as there is significant demand for the drugs that often come at a high cost. Within the program, Lilly will offer Zepbound KwikPen to network pharmacies at a discounted $449 price.
    • “What the patient ultimately pays could vary based on the employer’s cost sharing model and which partner they lean on, per the announcement.”
  • Fierce Pharma points out,
    • “Galderma has significantly raised its peak annual sales estimate for Nemluvio (nemolizumab) to more than $4 billion, doubling its previous projection of more than $2 billion. The update follows what CEO Flemming Ørnskov described as an “outstanding launch trajectory” for the inflammatory skin condition drug in its first full year on the market. 
    • “Driven by strong adoption in its existing indications of atopic dermatitis and prurigo nodularis (PN), Nemluvio posted $452 million in 2025 sales. Growth accelerated sharply in the second half of the year, with the period contributing $321 million to the total. It comes as real-world experience with the IL-31 receptor inhibitor exceeded initial expectations, Ørnskov said on Galderma’s fourth-quarter earnings call Thursday.”
  • and
    • “After delivering solid sales growth in a difficult 2025, Germany’s Merck KGaA may have a tougher go of things this year, which the company is crediting in part to a predicted onslaught of U.S. generics to its multiple sclerosis blockbuster Mavenclad. 
    • Approved by the FDA in 2019, Mavenclad delivered its third straight year of blockbuster sales in 2025, charting nearly 17% growth over the previous year to 1.2 billion euros ($1.4 billion) worldwide, Merck KGaA reported Thursday. In North America specifically, the drug reeled in 635 million euros ($735 million) last year, Merck noted in a detailed earnings report issued(PDF) March 5.” * * *
    • “[I]n an unfortunate turn for Merck, recent efforts to stave off Mavenclad patent challenges in the U.S. have fallen short, prompting the drugmaker to more or less throw in the towel on future growth for the MS med stateside. 
    • “In particular, Merck’s guidance for the year—anticipating sales between 20 billion euros and 21 billion euros, or -1% to 2% growth— “assumes no U.S. sales of Mavenclad from March 2026 amid generic competition.”  

Tuesday report

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare–

From Washington, DC

  • The Hill reports,
    • “Top Democrats are whipping against the Department of Homeland Security (DHS) funding bill expected to come to the floor this week, even as Republicans press them to support it in the wake of the U.S. attacks on Iran. 
    • “The White House and Democrats have been locked in an impasse over a deal to reopen DHS, as the minority party calls for the administration to overhaul Immigration and Customs Enforcement (ICE) following the killings of two U.S. citizens in Minnesota by federal agents.” 
  • Per a CMS news release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) released Medicare.gov Enhanced Login options. By providing people with Medicare these options, Medicare.gov is helping users better manage their health care information by delivering more login choices. People with Medicare do not need to create an account to access general Medicare information or their individualized Medicare information. If someone chooses to create an account, Medicare is providing new and free options with enhanced security to help protect their Medicare information.”
  • Beckers Payer Issues adds,
    • “Medicare Advantage plans looking to maintain no-premium models could face 50% cuts to supplemental benefits and $1,000 more in older adults’ cost exposure in 2027, according to February reports commissioned by health insurance trade association AHIP.
    • “Wakely Consulting Group conducted the research. The groups evaluated how CMS’ proposed 0.09% 2027 payment increase for MA would play out for insurers and their beneficiaries. AHIP sent the findings to CMS in a Feb. 25 letter.”
  • The Paragon Health Institute notes,
    • “The [Medicare] primary base hospital payment rate for inpatient services—known as the Inpatient Prospective Payment System (IPPS) operating base rate—has increased by 30 percent since 2016, mainly because of statutory formulas.  The outpatient services base rate—known as the Outpatient Prospective Payment System (OPPS) conversion factor—has increased by 26 percent since 2016, also mainly because of statutory formulas. Meanwhile, the physician base payment rate—known as the Physician Fee Schedule (PFS) conversion factor—has declined by 7 percent over the same period.
    • “The declining PFS conversion factor and the rising hospital base rates are not an accident but a result of policy choices made by Congress.” * * *
    • “To reduce distortions, hospital payments in Medicare should be subject to similar fiscal sustainability pressures as physician payments. Policymakers should consider proposals that address distortions and, in particular, site neutral payment policies that equalize payments for the same services across all providers.” 
  • Per an Institute for Clinical and Economic Review news release,
    • “The Institute for Clinical and Economic Review (ICER) today posted a Special Report on Entyvio® (vedolizumab, Takeda Pharmaceutical Co. Ltd.) for the treatment of ulcerative colitis and Crohn’s disease. This report will be submitted to the Centers for Medicare & Medicaid Services (CMS) as part of the 2026 public comment process defined in CMS guidance on Medicare Drug Price Negotiations for price applicability year 2028. 
    • “Downloads: Final Report
    • “Over three million people in the United States suffer from inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. Our special report focuses on the medical evidence for and value of Entyvio, which is commonly used to treat both conditions,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will support their ongoing efforts to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced Kurt Dykstra as General Counsel.
    • “Dykstra is an accomplished attorney with nearly three decades of experience handling complex workforce issues, regulatory compliance, internal investigations, and governance. His career spans corporate law, higher education, financial services, and public service, including leadership roles as a law firm shareholder, university counsel, college president, bank executive, mayor, and Major in the US Army Reserve.
    • “As OPM’s Chief Legal Officer, Dykstra will lead the Office of the General Counsel and advise the director and agency leadership on legal and policy matters.
    • “Kurt is a proven leader with the judgment and experience to help guide OPM through complex legal and workforce challenges,” said OPM Director Scott Kupor. “He understands how strong governance, accountability, and sound legal strategy support effective government. I am confident his leadership will help ensure OPM continues to serve federal employees and the American people with integrity and excellence.”
  • The Wall Street Journal relates,
    • “Patient Advocate Foundation and Patient Access Network Foundation merged, creating a nonprofit with over $800 million in assets.
    • “Kevin Hagan is chief executive of the combined Patient Advocate Foundation, which aims to serve patients facing rising costs.
    • “The combined foundation will launch a TotalAssist program in July and offer more than 130 disease-specific financial assistance funds.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration has been talking a big game about bringing artificial intelligence to patients. In January, when it announced relaxed rules for certain AI products, Commissioner Marty Makary said the agency is “developing a new regulatory framework for AI.” 
    • “How the agency will regulate rapidly-evolving uses of generative AI is one of the big questions facing health technology developers. Large language models’ wide-ranging applications evade simple measures of safety and efficacy, challenging the FDA’s longstanding approach to device validation — and the agency has yet to authorize a device that relies on generative AI. But a recent breakthrough designation from the FDA could offer hints about its approach to regulating patient-facing chatbots that fall under its purview. 
    • “In November, the FDA quietly handed one of its breakthrough device designationsto a chatbot for patients recovering from joint replacement surgery. Under development by RecovryAI, which is coming out of stealth as it announces the designation, the LLM-powered device would be prescribed to patients to use in the 30 days after surgery. It will encourage them to check in twice a day about their sleep, activity, diet, and other elements of recovery, answering questions and escalating to a care team when necessary.” 
  • Radiology Business adds,
    • “An artificial intelligence-enabled tool capable of accurately predicting an expectant mother’s delivery date has received the U.S. Food and Drug Administration’s De Novo clearance. 
    • “Ultrasound AI—a company that specializes in medical imaging AI applications—on Monday announced the clearance of its flagship Delivery Date AI technology. The product is a cloud-based software as a medical device that predicts delivery dates using ultrasound imaging alone. This could help to better prepare both patients and providers for potential complications, reducing the likelihood of preterm birth. 
    • “It was trained on a diverse dataset of over 1 million ultrasound images and evaluated via a peer-reviewed study, published in the Journal of Maternal-Fetal & Neonatal Medicine. The study, which included nearly 6,000 patients, determined AI could achieve an accuracy of 0.92 R² value for predicting the day a mother would deliver her child using only standard ultrasound images. 
    • “Delivery Date AI can be easily integrated into most ultrasound systems. Ultrasound AI indicates that installation takes just a few minutes and offers organizations scalability while also potentially reducing long-term costs by improving maternal outcomes.” 
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. 
    • “It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
    • “This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.”
  • Per BioPharma Dive,
    • “Pierre Fabre Pharmaceuticals has asked the Food and Drug Administration for an urgent meeting to discuss why the agency rejected a cell therapy for a post-organ transplant malignancy, the company said Tuesday, following claims by partner Atara Biotherapeutics that the agency contradicted its previous guidance.” * * *
    • “The regulatory dispute over Ebvallo is one of a series of recent squabbles between drugmakers and the FDA related to previous agreements on approval standards. On Monday, UniQure learned it will have to conduct another trial of a Huntington’s disease gene therapy. Last month, the agency initially refused to review a flu vaccine from Moderna before quickly changing course.”

From the judicial front,

  • Medical Economics tells us,
    • “Advanced analytics and multi-agency coordination are shortening investigative timelines and expanding parallel civil FCA, criminal, administrative, and state litigation exposure from a single operational issue. 
    • “Enterprise-level FCA theories are emphasizing systems, governance, and vendor relationships, with sustained focus on managed care, prescription drugs, and medically unnecessary services. 
    • “Medicare Advantage risk adjustment scrutiny is extending to incentive design, retrospective addenda, chart review vendors, and documentation tools that may be construed as rewarding coding intensity. 
    • “Telehealth platforms face continued controlled-substance risk despite extended prescribing flexibilities, with enforcement targeting clinical legitimacy, marketing representations, cross-state compliance, and decision-making controls. 
    • “Cybersecurity and privacy failures are becoming enforcement multipliers via FCA cyber-fraud theories, CCPA actions, and HIPAA tracking-technology scrutiny involving adtech and analytics data sharing.”
  • STAT News reports,
    • “Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot.
    • “Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts to have parts of its liability offloaded to the federal government fail upon appeal. If the full amount is paid, it will be among the largest patent settlements in history. 
    • “It is probably the largest ever,” said Jacob Sherkow, a professor of law and medicine at the University of Illinois Urbana-Champaign.
    • “The settlement comes less than a week before the two companies were set to go to a jury trial in Delaware, where legal experts say Moderna may have faced an uphill battle.\

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • To live long, be strong.
    • That’s the poetic implication of a new study of longevity and mortality in a large group of women aged 63 to 99.
    • “In the study, published in February in JAMA Network Open, researchers checked the women’s health, fitness, grip strength and lifespans. By analyzing that data, they hoped to tease out the importance of muscular strength for healthy aging.
    • “The results “were a bit of a surprise,” said Michael J. Lamonte, lead author of the study and a professor of epidemiology and healthy aging at the University of Buffalo in New York. Strength turned out to be a key — and singular — contributor to longer lives, he said, reducing the risk for early death by a third or more, even when the researchers took into account people’s aerobic fitness, health, age and exercise habits.”
  • The American Medical Association lets us know what doctors wish their patients knew about cystic fibrosis.
  • MedPage tells us,
    • “A meta-analysis found that women lost more weight than men while taking a GLP-1 receptor agonist.
    • “Biological differences, such as estrogen levels and body composition, may explain why women respond more to these agents.
    • “Weight loss was consistent across many other patient subgroups broken down by age, race and ethnicity, body mass index, and HbA1c.”
  • and
    • “Lithium carbonate might have slowed decline in verbal memory in a pilot study.
    • “However, the treatment did not meet a prespecified threshold for the trial’s primary outcomes.
    • “Earlier research suggested lithium may offer neuroprotective benefits in Alzheimer’s and dementia.”
  • Genetic Engineering and BioTechnology News points out,
    • “Immune monitoring is useful to monitor processes like vaccination and during diseases like infectious disease, cancer, and autoimmunity. However, detection of antigen-specific lymphocytes is challenging given that are low in frequency and have a dispersed distribution.
    • “Now, the first bandage-like, painless, microneedle patch that can sample the body’s immune responses from the skin has been developed. The device detects inflammatory signals within minutes and collects specialized immune cells within hours without the need for blood draws or surgical biopsies.
    • “The study appears in Nature Biomedical Engineering in the paper, “Leveraging tissue-resident memory T cells for non-invasive immune monitoring via microneedle skin patches.”
    • “The patch is helping researchers and clinicians study immune responses in aging and skin autoimmunity, including vitiligo and psoriasis. In the future, it could make it easier to track how people respond to vaccines, infections, and cancer therapies by complementing traditional blood tests and biopsies while being far easier on patients.”
  • Per BioPharma Dive,
    • “Shares of Aardvark Therapeutics lost more than half their value after safety worries led the biotechnology company to halt testing of its most advanced drug prospect. 
    • “Aardvark said Friday that, “out of an abundance of caution,” the company has voluntarily paused dosing and enrollment in a Phase 3 trial of ARD-101, an experimental drug it’s been developing for the rare genetic disease Prader-Willi syndrome. According to Aardvark, trial monitors detected “reversible cardiac observations” during a routine safety check in a study of healthy volunteers.” 
  • and
    • “Kyowa Kirin will stop all trials of an eczema drug once seen as a possible future blockbuster, claiming a new safety review has led the company to believe that the treatment’s risks may outweigh its benefits.
    • “In a Tuesday statement, the company said a planned evaluationconducted by the company and former development partner Amgen in recent weeks unearthed “emerging concerns of malignancies” related to treatment with a therapy known as rocatinlimab. These concerns included one new confirmed case and another suspected case of Kaposi’s sarcoma, a cancer that forms around skin lesions.”
    • “The findings suggest a potential link between onset of the cancer and the drug’s mechanism of modulating an immunogical pathway called OX40. While the overall number of cases is below expected background rates, the “characteristics” involved “raised a plausible biological concern that cannot be excluded,” the company said.
    • “All studies will be discontinued after study participants complete their required safety follow-up visits, Kyowa Kirin added.”

From the U.S. healthcare business front,

  • Beckers Hospital Review relates,
    • “Rochester, Minn.-based Mayo Clinic recorded an income from current activities of $1.5 billion (6.8% margin) in 2025, up from $1.3 billion (6.5% margin) in 2024.”
  • and
  • and
    • “Nacogdoches County Hospital District in Nacogdoches, Texas, unanimously approved a new lease agreement with Dallas-based Tenet Healthcare on Feb. 27, The Nacogdoches Daily Sentinel reported March 2.
    • “The 15-year lease agreement designates Nacogdoches Memorial Hospital and Cecil R. Bomar Rehabilitation Center as campuses of Nacogdoches Medical Center. Tenet, which operates Nacogdoches Medical Center, will assume daily operations of Nacogdoches Memorial Hospital.”
  • and
    • “Nashville, Tenn.-based HCA Healthcare and Ascension are planning competing freestanding emergency departments in Fairview, Tenn., a fast-growing community in western Williamson County.”
  • Fierce Healthcare tells us,
    • “Health systems interested in preserving their operating margins will need to be proactive in addressing a growing minority population responsible for an outsized share of care utilization: patients with multiple chronic conditions. 
    • “In a newly released analysis of 2025 claims data, Vizient found that 11% of the U.S. population with multiple chronic conditions accounted for 52% of inpatient admissions. These patients also represented 35% of emergency department visits and 32% of office visits.
    • “To put it another way—compared to those without any chronic disease, these patients have about 10 times more inpatient admissions and ED visits, as well as six times as many office visits. Further, ED and office visits among those with multiple chronic conditions are projected over the next decade to grow at nearly double the rate of those with a single chronic condition, who are also higher care utilizers.
    • These patients pose a major financial challenge for providers due to their unfavorable payer mix. Specifically, Vizient found that 72% of inpatient admissions for those with multiple chronic conditions were covered by Medicare and another 10% by Medicaid. 
  • and
    • “Grow Therapy, a hybrid mental health provider, has clinched $150 million to build out physician and employer relationships.
    • “The series D round was led by TCV and Growth Equity at Goldman Sachs Alternatives, with participation from new investors BCI and Menlo Ventures. 
    • ‘Physicians and employers are newer customer types for Grow but have been the focus of the platform’s growth over the past five years. The capital will also be used to strengthen the tech powering Grow and enhance the user experience for patients, therapists and other partners.
    • “Grow has amassed a range of partners that today includes 125 payers, provider groups like Circle Medical, health systems like Kaiser Permanente and employers. Primary care docs are of particular focus to Grow right now, given they deliver 60% of the nation’s mental healthcare.” 
  • MedTech Dive informs us,
    • “RadNet has struck a 230 million euros deal to buy radiology artificial intelligence company Gleamer.
    • “The takeover, which the companies disclosed Monday, gives RadNet control of devices that are used in more than 25 indications and are forecast to generate about $30 million in annualized recurring revenue this year.
    • “Buying Gleamer will expand the capabilities RadNet acquired through the DeepHealth buyout in 2020, particularly in X-ray, and accelerate its expansion outside the U.S. Gleamer will be integrated into DeepHealth, a full-owned subsidiary of Radnet.”