Tuesday report

David Ermer

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

Tuesday report

David Ermer–Congress, Employee Wellness Programs, FDA, Generative AI, NIH, No Surprises Act, Obesity, U.S. Healthcare–

From Washington, DC

  • Bloomberg Law reports,
    • “Another reconciliation bill represents a “tremendous opportunity”for Republicans to pass key policy priorities before the midterm elections, a House GOP tax-writer said Monday.
    • “Rep. Beth Van Duyne (R-Texas), a member of the House Ways and Means Committee, said at a Bloomberg Government roundtable that Republicans want a second shot at passing several provisions that were axed from their first reconciliation bill passed last year.
    • “It was a heavy lift to do reconciliation 1.0,” Van Duyne said. “But I think there’s a lot of parts of that bill that got washed out in the Byrd bath that we would like to be able to see put in reconciliation 2.0.” * * *
    • “Republican leaders including Ways and Means Chairman Jason Smith (R-Mo.) along with President Donald Trump have been cool to the idea of starting work on a second party-line bill given how challenging it was to pass the first bill, though a number of rank-and-file GOP lawmakers have clamored for it.
    • “There’s a lot of very strong bills that would be productive to be able to have passed and the only way that we can do that is put it in reconciliation,” Van Duyne said.”
  • and
    • “More than three dozen employers, insurers, and patient advocacy groups are askingthe Trump administration to intervene in the arbitration process for surprise medical bills. 
    • “Dysfunction under the No Surprises Act has flooded the courts with cases of alleged fraud on both sides. Insurers accuse providers of knowingly submitting ineligible claims to the arbitration process, while providers allege insurers are misleading arbitrators on key payment metrics.
    • “Health insurance companies and employers are losing the vast majority of cases under the law. Data from the Centers for Medicare & Medicaid Services, which oversees the arbitration process, show that providers are winning 88% of the time. But courts are largely siding with insurers when providers allege they aren’t paying up, saying that enforcement resides with the CMS.
    • “The Office of Management and Budget is reviewing a final rule to improve the independent dispute resolution process, which requires arbitrators to settle out-of-network bills between doctors and insurers. The rule has languished since the Department of Health and Human Services first proposed it in November 2023 as a series of legal challenges from the Texas Medical Association unfolded in the courts.
    • “More transparency and accountability is needed for companies that oversee arbitration, the ERISA Industry Committee, American Benefits Council, Business Group on Health, Elevance Health, union 32BJ Health Fund, and others said in a letter Tuesday.”
  • FEHBlog note — With regard to transparency, one of the factors that the arbitrators consider is patient acuity. A health plan can only guess at that factor. That’s unreasonable. The arbitration process should better align with American Arbitration Association rules for baseball arbitration.
  • Mobihealth News relates,
    • “Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services (CMS), said during an Action for Progress event focused on addiction and mental health that AI avatars are the best way to help rural communities access mental healthcare.
    • “We do not have enough practitioners for mental health support in these areas,” Dr. Oz said during the event.
    • “I’m telling you right now. There’s no question about it – whether you want it or not – the best way to help some of these communities is going to be AI-based avatars.”
    • “He proposed using agentic AI with the ability to conduct early mental health intakes, customize support to a patient’s needs and understand what a patient is “up to.”  
    • “[These tools] will pick up subtle little nuances in how you’re saying things – if you do it on purpose, it’s actually cool to find out – that will alert the avatar, but more importantly, the doctor they are going to report to that there is something going on,” Oz said. “And there will always be a doctor.”
    • “He framed the use of AI avatars to be used in conjunction with clinicians as, he said, humans are biologically designed to interpret facial cues, such as happiness, boredom, excitement and more, before a person verbalizes it.
    • “The key question is how do we use AI thoughtfully in that setting? If we do it right, we’ll build a much more sustainable healthcare system around mental health issues,” Oz said.”  

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • “Four years after the FDA issued its most heavy-handed form of a rejection to the prior company behind pegzilarginase, the U.S. regulator has now given the treatment a thumbs-up.
    • “Scoring the accelerated nod is Immedica Pharma for Loargys as a therapy for hyperargininemia in the ultrarare genetic disorder Arginase 1 deficiency (ARG1-D). The approval covers patients age 2 and older, with the therapy to be used in conjunction with a protein-restricted diet. 
    • “Loargys, which is also known as pegzilarginase, is a recombinant human enzyme designed to lower levels of arginine in patients who are unable to break down the amino acid. It is the first treatment to address the elevated levels of plasma arginine associated with the disorder.”
  • and
    • “Sanofi and Regeneron’s megablockbuster immunology drug Dupixent has gained yet another FDA approval, this time in allergic fungal rhinosinusitis (AFRS).
    • “The U.S. regulator signed off on the drug as a treatment for adults and children ages 6 and older with AFRS based on late-stage trial data showing Dupixent reduced nasal signs and symptoms and systemic corticosteroid use or surgery compared to placebo, according to a Feb. 24 press release.” * * *
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.” * * *
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approved as an every-two-week regimen.”
  • and
    • “Just three months after further scaling back its support for the struggling hemophilia A gene therapy Roctavian, the company is walking away altogether by pulling the treatment from the market. 
    • “The move follows a “comprehensive effort” to identify a potential buyer for the therapy, BioMarin explained Monday in its fourth-quarter earnings press release.” 

From the public health and medical / Rx research front,

  •  Health Day relates,
    • “You don’t need to look buff or tough, but muscle strength can influence how long you’ll live, a new study says.
    • “Older women with greater strength had a significantly lower risk of death during an eight-year follow-up, researchers recently reported in JAMA Network Open.
    • “The study measured women’s grip strength and ability to rise from a seated to standing position — two tests commonly used to determine seniors’ strength levels.
    • “Women had a 12% lower death rate for every 15 additional pounds of grip strength they exhibited during testing, researchers found.
    • “Likewise, they had a 4% lower death rate for every 6 seconds faster they could complete five sit-to-stand chair raises, results showed.”
  • and
    • “Teens who use weed are twice as likely to develop psychotic or bipolar disorders, a new study says.
    • “They also are more likely to have depression and anxiety, researchers reported Feb. 20 in JAMA Health Forum.
    • “As cannabis becomes more potent and aggressively marketed, this study indicates that adolescent cannabis use is associated with double the risk of incident psychotic and bipolar disorders, two of the most serious mental health conditions,” researcher Dr. Lynn Silver said in a news release. She’s a program director at the Public Health Institute in Oakland, California.
    • “More than 10% of 12- to 17-year-olds in the U.S. have used weed within the past year, researchers said in background notes. By their senior year in high school, about 26% of U.S. teenagers have tried it.”
  • and
    • “Side effects like nausea or vomiting are common among folks taking Ozempic/Wegovy, but they’ll grin and bear it if they think they’re losing weight, a new study finds.
    • “The drugs’ perceived effectiveness — lost weight, less appetite, fewer food cravings — outweigh GI side effects, researchers reported recently in the Journal of Medical Internet Research.”
  • MedPage Today informs us,
    • “Hepatitis B vaccination rates among U.S. newborns have fallen by more than 10 percentage points over the past 2 years.
    • “Those rates climbed steadily for 6 years, peaking at 83.5% in February 2023 before dropping to 73.2% by August 2025.
    • “The drop began months before the CDC’s Advisory Committee on Immunization Practices voted in December to stop universally recommending the birth dose.”
  • and
  • Per an NIH news release,
    • “A study funded by the National Institutes of Health (NIH) reduced new HIV cases by 70% in rural Kenya and Uganda by pairing digital tools with tailored HIV services delivered by community health workers and clinicians. This successful strategic implementation of existing healthcare infrastructure and available HIV prevention and treatment options could become a model for reducing HIV incidence in other countries, including the United States. The findings were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver.”  
  • Here’s a link to the latest edition of NIH’s Research Matters which covers the following topics:

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

  • The Wall Street Journal reports,
    • Novo Nordisk NOVO.B plans to slash U.S. list prices for its popular weight-loss and diabetes drugs Wegovy and Ozempic by up to half starting next year.
    • Under the changes, both Ozempic and Wegovy will list for $675 a month, effective Jan. 1, 2027. That is half of the current price tag for anti-obesity therapy Wegovy and a 34% cut for diabetes treatment Ozempic. The price cuts also will apply to pill versions of both injections, including one sold as Rybelsus.
    • The reductions escalate a price war with rival Eli Lilly LLY -1.40% in one of the fastest-growing, most hotly contested categories in pharmaceuticals.
  • Optum Rx, writing in LinkedIn, discusses the next phase of the GLP-1 revolution.
  • STAT News relates,
    • “In the last year and a half, direct-to-consumer telehealth company Hims & Hers has become a leading voice in the debate over compounded GLP-1 weight loss medications. On Monday, it announced earnings from the last quarter of 2025 after a whirlwind month that raised questions about the regulatory risks of the company’s compounding model and the threat of an investigation. 
    • “In the call, Hims & Hers CEO Andrew Dudum addressed the increased scrutiny on compounded GLP-1s and its impact on the business’s bottom line, emphasizing Hims’ other medications, including for weight loss. “We believe there’s a really durable weight business,” said Dudum, “even if you think you’re kind of in a draconian scenario of compounding GLP-1s not being there.”
  • Fierce Healthcare tells us,
    • “Employers are spending more on women’s and family health, but that is not always being felt by employees, a new report finds.
    • “The Maven Clinic released its fifth annual State of Women’s & Family Health Benefits report, which is based on responses from over 2,000 HR leaders and nearly 5,000 full-time employees across the U.S., U.K., Canada and India. The report highlights how rising healthcare costs are reshaping how employees seek care and what actions employers are considering to help address those costs.
    • “Though employers reported a 39% average increase in women’s and family health benefits offered year-over-year, the share of employees who felt their benefits support them “very well” dropped 10% on average. Globally, across all benefits, employers were slightly more likely to add or enhance benefits in the next year compared to those in the U.S.”
    • “From Maven’s perspective, all the report’s findings highlight the need for an integrated approach to benefits and care delivery.
    • “We think that the category continues to show importance, and that is a positive,” Stephanie Glenn, chief commercial officer at Maven, told Fierce Healthcare. 
    • “But the gap in what’s being offered and what employees are feeling exists because of a lack of thoughtful integration, she added. “Unless it’s a coordinated offering, if you get a one-time email about a new benefit, it’s very disjointed. You don’t understand what it looks like,” she said.”
  • Healthcare Dive tells us,
    • “Thirty-one thousand Kaiser Permanente nurses and other healthcare professionals in California and Hawaii ended a major strike Tuesday after about a month on the picket lines. 
    • “In a statement Monday, the workers’ union, the United Nurses Associations of California/Union of Health Care Professionals, said “significant movement” at the bargaining table over the past two days prompted leaders to end the strike.
    • “Returning members to their patients and their livelihoods is the clearest path to securing a final agreement and building on the progress achieved during the strike,” the UNAC/UHCP said.”
  • and
    • “Home health and hospice provider Enhabit has agreed to be taken private by private equity firm Kinderhook Industries in a deal worth $1.1 billion.
    • “Under the deal terms announced Monday, shareholders will receive $13.80 in cash per share, representing an almost 25% premium over Enhabit’s closing stock price on Feb. 20. 
    • “The Dallas-based provider — which has almost 250 home health locations and over 115 hospice locations in 34 states — will cease trading on the New York Stock Exchange when the deal closes, which the companies expect to happen in the second quarter this year.”
  • Beckers Hospital Review notes,
    • “For the first time, women now make up the majority of physicians in U.S. training programs, according to the Association of American Medical Colleges’ annual report on residency trends. 
    • “In the 2024-25 academic year, women accounted for 50.2% of residents and fellows across all specialties and subspecialties, per the report. The figure marks a stark contrast from the 1970s, when women comprised less than 10% of physicians, and reflects decades of steady growth in female representation in medical schools and training programs.”
  • and
    • “If healthcare IT were golf, CIOs would take a few mulligans.
    • “Choosing and installing an EHR is often one of the biggest, most complicated decisions IT leaders will ever make, and some executives told Becker’s they would do things differently if they could go back in time.”
  • Per MedTech Dive,
    • “Medtronic on Tuesday priced a planned initial public offering for its MiniMed diabetes spinoff at up to $784 million.
    • “MiniMed plans to price its IPO between $25 and $28 per share across 28 million shares. Underwriters will also have the option to buy an additional 4.2 million shares at the IPO price.
    • “Medtronic first announced plans to spin out its diabetes business into a separate, publicly traded company in May. The new firm would be the only company in the market that sells both insulin pumps and continuous glucose monitors.”

Monday report,

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

From Washington, DC,

  • The Hill reports,
    • “Lawmakers return to Capitol Hill this week facing an uphill climb to fund the Department of Homeland Security (DHS) as Republicans see an opening after President Trump’s State of the Union address on Tuesday despite few signs that Democrats are willing to compromise on their demands.”
  • The Congressional Budget Office tells us,
    • “The Congressional Budget Office regularly updates the Congress on our projections of the Hospital Insurance (HI) Trust Fund’s financial position as well as changes in our outlook on that position. This blog post serves as that update.
    • “The HI trust fund is used to pay for benefits under Medicare Part A, which covers inpatient hospital services, care provided in skilled nursing facilities, home health care, and hospice care. The fund derives its income from several sources. Over the next 30 years, about three-quarters of its annual income comes from the Medicare payroll tax and roughly one-eighth comes from income taxes on Social Security benefits. The rest comes from other sources.” * * *
    • “The year in which the HI trust fund’s balance is exhausted in our current projections, 2040, is 12 years earlier than in our most recent estimate of that date, which was published in March 2025. Measured in relation to taxable payroll, the trust fund’s 25-year actuarial deficit is 0.17 percentage points greater in the current projections than in last year’s. (Measured in relation to GDP, the actuarial deficit is 0.07 percentage points greater than we projected last year.) Those changes are driven largely by projections of less income to the fund. Projections of greater spending also contribute to the changes.”
  • STAT New reports,
    • “More evidence is starting to show the government’s arbitration process to settle out-of-network bills has morphed into a cash cannon for doctors and medical groups.
    • “Jinghong Chen of Payer Perspectives sifted through the latest federal data covering the arbitration process created by the No Surprises Act and found that not only are medical groups winning nearly nine out of every 10 cases, they are also getting paid more than anyone can imagine.
    • “The NSA’s arbitration process encouraged the use of the “qualifying payment amount” — essentially the average in-network rate that providers in a given area have agreed to — as a benchmark for disputes. How quaint. Instead, medical groups have fought for, and won, astronomically higher amounts. 
    • “Radiologists are winning offers that are, on average, almost 500% of the typical in-network rate, according to Chen’s analysis. Surgeons are getting payments for contested services that are a median 1,320% above the in-network rate. Neurology and neuromuscular procedures have median winning offers of nearly 2,400% above the in-network average.”
  • Govexec informs us,
    • “Federal supervisors are poised to soon face limitations on how many employees they can rate as above average in their annual performance reviews after the Trump administration on Monday proposed upending the process for evaluating civil servants. 
    • “The Office of Personnel Management’s proposed rule would implement the first major overhaul of the federal employee performance management system in decades. The Trump administration is aiming to correct for what it views as inflated ratings within the federal workforce. 
    • “The rule, which OPM will formally release on Tuesday, largely mirrors a draft version Government Executive exclusively obtained and reported on in December.”
  • The Affordable Care Act regulators announced today their decision to extend the public comment period for the proposed rule that appeared in the Federal Register on December 23, 2025, titled “Transparency in Coverage” from February 23, 2026, to March 2, 2026.
  • The New York Times reports,
    • “Adding to a rapid shake-up of the leadership at federal health agencies, the Centers for Disease Control and Prevention announced on Monday that Dr. Ralph Abraham had resigned as the agency’s principal deputy director.
    • “His departure thins the ranks of vaccine skeptics at the agency’s helm, a sign of the administration’s pivot away from the agenda pursued thus far by Health Secretary Robert F. Kennedy Jr. and his appointees.
    • “Dr. Abraham’s resignation, which comes less than three months into the job, was effective immediately, the agency said in a statement on its website.” 

From the Food and Drug Admininstration front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly has launched a multidose version of its blockbuster weight loss drug Zepbound that gives patients a month’s worth of treatment in a single injection pen.  
    • “On Feb. 23, the drugmaker said the FDA approved a label expansion for Zepbound (tirzepatide) to include the four-dose, single-patient-use KwikPen. The device contains four weekly doses, reducing the number of pens patients need each month compared with single-dose injectors.
    • “The KwikPen will be available by prescription for self-paying patients through LillyDirect, Eli LIlly’s direct-to-consumer platform. Prices start at $299 per month for the lowest dose. Patients choosing the self-pay option can access all approved doses in either the multidose pen or single dose vial at the same price, the company said.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today issued draft guidance for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations. 
    • “The draft guidance, issued by the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, specifically discusses genome editing and RNA-based therapies such as antisense oligonucleotides but leaves open the potential that this framework may apply to additional tailored therapeutics provided they directly address the underlying specific cause of the disease.” * * *
    • “The draft guidance, Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause, is available for public comment. Comments must be submitted within 60 days of publication in the Federal Register at Regulations.gov.”
  • Per Fierce Pharma,
    • “Vanda Pharmaceuticals is riding a regulatory roller coaster over the last few months. December brought an FDA thumbs up for its new motion sickness drug Nereus. Then in January, the U.S. regulator re-upped its rejection of Vanda’s Hetlioz for jet lag disorder.
    • “Now in February, the agency has issued another new drug approval to Vanda, signing off on Bysanti as a first-line treatment for schizophrenia or for manic or mixed episodes associated with bipolar I disorder. 
    • :The atypical antipsychotic tablet, also known as the chemical compound milsaperidone, has demonstrated in clinical trials its bioequivalence to Vanda’s Fanpat (iloperidone), which has been approved in the same two indications.”
  • and
    • “Only a month after Jazz Pharmaceuticals said it had signed a deal to sell an FDA priority review voucher (PRV) for $200 million, a new PRV transaction involving Fortress Biotech and an unnamed buyer shows that the trend of rising voucher prices is still going strong.
    • “Monday morning, Fortress said its subsidiary, Cyprium Therapeutics, has entered into an agreement to sell a recently received rare pediatric disease priority review voucher for $205 million. Cyprium got its hands on the PRV as part of the FDA’s recent approval of injected copper replacement therapy Zycubo as the first treatment approved in the U.S. for the rare neurodegenerative disorder Menkes disease.
    • “While another company, Sentynl Therapeutics, is handling development and commercialization of Zycubo under a 2023 agreement, the deal called for Sentynl to transfer the PRV back to Fortress/Cyprium after the approval.”  

From the public health and medical / Rx research front,

  • STAT News reports,
    • “Women’s bodies are different from men’s in ways that medicine is still learning. Meanwhile, their risk of serious cardiovascular events can be underestimated if their distinct risk profiles are blurred with men’s. 
    • “The latest example of important sex differences centers on the plaque burden in coronary arteries — a measure of fat and cholesterol deposits that also accounts for blood vessel size. 
    • “Women tend to have lower volumes of plaque than men, but their total plaque burden is higher because the fatty deposits take up a larger fraction of their smaller coronary arteries. Their risk for a heart attack or hospitalization for chest pain emerged when their plaque burden was lower than men’s, and their risk climbed more steeply, too, a new study published Monday in Circulation: Cardiovascular Imaging concluded.”
  • The Washington Post relates,
    • “Obstetrician Jeanne Conry has long paid attention to the “1,300-day window”— the months before conception through a child’s second birthday. Studies show nutrition and lifestyle during this period can shape pregnancy outcomes and the long-term health of the babies. Conry began to wonder if such factors could also influence autism.
    • “She is now helping lead an educational push aimed at alerting women to their exposure to toxins, stress and infections during this narrow and consequential window — guided by the idea that what happens then may subtly shape eggs or sperm, and in turn, influence a child’s development long before pregnancy begins.
    • “The more we research, the more we see links between different chemical exposures and autism so if we reduce those links we will ideally reduce cases,” Conry said.”
  • STAT News also informs us,
    • “Novo Nordisk’s next-generation weight loss drug CagriSema, one of the company’s key hopes to help it regain its footing in the increasingly competitive obesity market, failed in a key study that compared it to rival Eli Lilly’s tirzepatide, Novo said Monday. 
    • “The open-label REDEFINE 4 study was designed to test whether CagriSema could help patients lose the same amount of weight as those who received tirzepatide, which is sold as Zepbound and Mounjaro. But over 84 weeks, patients in the CagriSema arm saw a weight loss of 20.2%, versus 23.6% for those getting tirzepatide. Statistically, the results did not show that CagriSema performed equivalently to Lilly’s drug — what’s known as non-inferiority.” 
  • The Hill adds,
    • “An ingredient in the prescription diabetes drug Mounjaro was found to reduce alcohol intake in rodents, according to a recent study. 
    • “In the study, published in early January in the medical journal eBioMedicine, researchers in Sweden, South Carolina and Brazil looked at how the ingredient, tirzepatide, affected rodents. The researchers found that alcohol’s “rewarding properties” were lessened by the ingredient and that behaviors including the voluntary consumption of alcohol and binge drinking dropped.
    • * * * “In summary, our findings indicate that tirzepatide influences alcohol-related responses in ways that appear to have clinical potential. Tirzepatide consistently reduced alcohol intake across different drinking paradigms and both sexes without signs of tolerance development,” the researchers wrote.
    • “Perhaps more significantly, tirzepatide’s effects on relapse behaviours suggest it might help decrease relapse vulnerability, a finding that could prove important for therapeutic applications,” they added.”
  • The American Medical Association lets us know “What doctors wish patients knew about food allergies.”
    • “Milk, eggs, peanuts, tree nuts, fish, shellfish, wheat, soy and sesame are the “Big Nine” food allergies. Two allergists share more about food allergies.”
  • NPR adds,
    • “Ultra-processed foods are industrially manufactured products that contain ingredients rarely found in your kitchen, such as preservatives, artificial sweeteners, colorings, natural flavors and emulsifiers. Numerous studies have shown that these foods increase the risk of a host of health problems, including diabetes, heart disease, depression and obesity.
    • “When people ask me about ultra-processed foods, they’re often most confused about grains, carbohydrates and starches,” says Dr. Dariush Mozaffarian, who leads the Food is Medicine Institute at Tufts University. These foods include breads, crackers, pretzels, pea snaps, veggie straws, pastas and puffed rice or corn. “People want to know how to choose more healthful versions of these products,” he says.
    • “So Mozaffarian gives his patients two practical rules of thumb to follow when selecting grains and starches: the 10 to 1 test and the water test.”
  • Cardiovascular Business points out,
    • “The risk of death following percutaneous coronary intervention (PCI) remains incredibly low, according to new findings published in The American Journal of Cardiology.[1] When it does occur, acute myocardial infarction (AMI), cardiac arrest and infection are two of the most common reasons.
    • “Estimating the risk of periprocedural mortality after percutaneous coronary intervention (PCI) is crucial for risk stratification and quality assessment,” wrote Dimitrios Strepkos, MD, a researcher with the Minneapolis Heart Institute Foundation, and colleagues. 
    • “Strepkos et al. examined data from the PROGRESS-COMPLICATIONS registry, focusing on more than 22,000 patients who underwent PCI from 2014 to 2024 at one of two high-volume U.S. facilities. The overall technical success rate was 78.3%. While 14.8% of patients underwent atherectomy as part of the procedure, 6.1% underwent intravascular lithotripsy.”

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

  • The Wall Street Journal reports,
    • “Merck MRK is shaking up the leadership of its main pharmaceutical unit as the U.S. drugmaker braces for sales pressure later this decade.
    • “The Rahway, N.J.-based company said Monday it will split its human-health business into two divisions. One will house its cancer drugs, including the blockbuster Keytruda. The immunotherapy accounts for nearly half of total Merck sales but is due to lose U.S. patent protection in 2028, exposing it to lower-cost copycat competition.
    • “The second new division—the specialty, pharma and infectious-diseases business unit—will sell noncancer products, including the HPV vaccine Gardasil, diabetes drug Januvia and newer products such as lung-disease treatment Winrevair. 
    • “Merck is counting on this unit to generate big sales growth to offset the expected Keytruda sales decline.” 
  • Beckers Hospital Review reports,
    • “Nacogdoches (Texas) County Hospital District is eyeing a new lease agreement with Dallas-based Tenet Healthcare that would merge Nacogdoches Memorial Hospital with Nacogdoches Medical Center, ABC affiliate KTRE reported Feb. 19.
    • “Under the proposed deal, the two hospitals would operate under unified management.
    • “Consolidating the hospitals would help the district sustain care for the community’s underserved population while benefiting from the resources and support of a larger health system, David Schaefer, vice president of the hospital district’s board, told the media outlet.” 
  • MedTech Dive notes,
    • “Guardant Health has acquired MetaSight Diagnostics for $59 million in upfront cash to bolster its multi-disease detection pipeline, the company said Thursday. The deal includes up to $90 million in payments tied to future commercial performance and regulatory approvals.
    • “MetaSight uses mass spectrometry multi-omics technology to find biomarkers associated with acute and chronic diseases in serum samples. Tests for colorectal cancer, an area of focus for Guardant, and liver disease-associated fibrosis were MetaSight’s two most advanced programs just before the acquisition.”  
  • Fierce Healthcare points out,
    • “As providers rapidly adopt artificial intelligence technology for clinical documentation, there is a demand for AI clinical assistants that meet the needs of specialty medicine practices.
    • “Health tech company Nextech recently launched its next-generation AI assistant, called Cora, along with its clinical documentation feature, Cora Scribe, to provide AI technology that was designed with specialty workflows in mind, according to the company.
    • “Nextech provides electronic medical record and practice management software to specialty physician practices as well as revenue cycle management (RCM), customer relationship management (CRM) and other software systems. The company supports 16,000 physicians, more than 5,500 practices and 60,000 office staff members in the clinical specialties of dermatology, ophthalmology, orthopedics, plastic surgery and medical spa practices.”
  • The American Hospital Association News adds,
    • “The AHA responded to a request for information today from the Department of Health and Human Services on the adoption and use of artificial intelligence in clinical care. The AHA urged HHS to synchronize and leverage existing AI policy frameworks to avoid redundancy, remove regulatory barriers that inhibit the development and deployment of AI tools, adopt policies ensuring the safe and effective use of AI, and align incentives and address infrastructural factors necessary to expand AI in health care.  
    • “The AHA’s comments build upon previous responses to RFIs on regulation and reimbursement for AI, including an RFI from the Office of Science Technology Policy on ways to reduce regulatory burden for AI, an RFI from the Food and Drug Administration on measuring and evaluating AI-enabled medical devices, and RFIs from the Centers for Medicare & Medicaid Services on payment for AI tools through the calendar year 2026 Outpatient Prospective Payment System proposed rule and CY 2026 Physician Fee Schedule proposed rule.”

Weekend Update

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

Happy Washington’s Birthday!

From Washington, DC,

  • The President will give his State of the Union address Tuesday night, February 24.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Per a Department of Homeland Security news release, TSA is closing pre-check and Global Entry lines at airports starting today due to the continuing DHS shutdown. Other steps are identified in the release.
  • The Washington Post adds,
    • “The Department of Homeland Security reversed course Sunday morning after saying that it would suspend TSA PreCheck because of the partial government shutdown.
    • “TSA PreCheck remains operational with no change for the traveling public,” the Transportation Security Administration said in a statement. “As staffing constraints arise, TSA will evaluate on a case by case basis and adjust operations accordingly.”
    • “A DHS official, speaking on the condition of anonymity to discuss internal processes, said the change was “based off of conversations the secretary had with the White House and TSA.
    • “The Global Entry program, however, will remain paused, according to the official.”
  • Healthcare Dive reports,
    • “GE HealthCare has won a $35 million U.S. government contract expansion to develop artificial intelligence-enabled ultrasound technology for trauma care, the company said Tuesday.
    • “Building on a deal made in 2023, GE HealthCare will develop AI-powered tools to make it faster and easier for people, including non-expert ultrasound users, to diagnose patients.
    • “GE HealthCare is jointly funding the latest phase of the project, although it said the Biomedical Advanced Research and Development Authority will provide most of the money.”
  • The GAO Watchblog informs us
    • “The federal government makes all kinds of payments each day, everything from Social Security benefits to payments for weapon systems. But sometimes errors occur, including payments to dead people. 
    • “A pilot program has helped to reduce how often these errors occur. And it was so successful that the president recently signed a law to make it permanent—an action that GAO recommended. While the program helped reduce payment errors, it comes with financial costs that should be addressed. 
    • “Today’s WatchBlog post looks at our new report on the success of this effort and its costs. “

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The hours you spend tracing countries on a globe or puzzling over a chessboard may add up to more than idle time. According to a new study, such mentally stimulating pursuits are linked to years-long delays in Alzheimer’s disease and mild cognitive impairment.
    • “Published this month in Neurology, the journal of the American Academy of Neurology, the study is among the largest of its kind, following 1,939 adults with an average age of 80 and tracing their cognitive trajectories alongside a lifetime of reported activities stretching back to childhood.
    • “The contrast between the most and least cognitively enriched participants was stark. Those in the top 10 percent developed Alzheimer’s at an average age of 94; those in the bottom 10 percent, at 88. Mild cognitive impairment showed a similar split: 85 in the highest group, 78 in the lowest.
    • “Five years’ difference for Alzheimer’s. Seven for mild cognitive impairment.
    • “I was positively surprised,” Andrea Zammit, a study co-author and an assistant professor of psychiatry and behavioral sciences at Rush University Medical Center in Chicago, said.”
  • Health Day adds,
    • Skip your late-evening snack and wind down for the day with the lights dimmed low.
    • That simple shift in your end-of-the-day routine is good for your heart, new research demonstrates.
    • “Timing our fasting window to work with the body’s natural wake-sleep rhythms can improve the coordination between the heart, metabolism and sleep, all of which work together to protect cardiovascular health,” said study author Dr. Daniela Grimaldi, a research associate professor of neurology in sleep medicine at Northwestern Feinberg School of Medicine in Chicago.
    • The sweet spot is three hours.
    • Dimming lights and avoiding food that long before bed resulted in measurable gains in heart and metabolic markers during sleep and the entire next day, she and her colleagues reported Feb. 12 in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.
  • MedTech Dive relates,
    • “Apple Watch’s hypertension notification feature may miss some casesacross different patient demographics, according to a research letter published last week in JAMA.
    • “Researchers at the University of Pennsylvania and University of Utah applied performance metrics for the feature to U.S. population statistics to estimate its impact. They found about 69% of people who received an alert have hypertension, and about 79% of people who don’t receive an alert do not have hypertension. The feature’s performance varied by age, race and ethnicity.
    • “Jordana Cohen, the study’s lead author and an associate professor of medicine and epidemiology at the University of Pennsylvania School of Medicine, wrote in an email that the analysis suggests an alert meaningfully increases the likelihood that a person has hypertension. “However, the absence of an alert provides limited reassurance, particularly in older and higher-risk adults, and routine blood pressure measurement with validated cuff-based devices remains essential,” Cohen wrote.”
  • MedPage Today tells us “What to Know About ALS After Actor Eric Dane’s Death.”
    • “Actor Eric Dane, known for his role in “Grey’s Anatomy,” died this week at age 53, less than a year after announcing he had amyotrophic lateral sclerosis (ALS).
    • “Dane became an advocate for ALS awareness soon after his diagnosis in April 2025 and was named the recipient of the ALS Network Advocate of the Year Awardopens in a new tab or window last September.
    • “Eric’s passing is a huge loss for our ALS advocacy community,” said Evangelos Kiskinis, PhD, associate professor of neurology and neuroscience at Northwestern University Feinberg School of Medicine in Chicago.”

From the U.S. healthcare business front,

  • Fierce Healthcare adds,
    • “Virtual care company Omada Health is expanding its cardiometabolic care management platform with supports for individuals with high cholesterol.
    • “The company said Thursday that while as many as 70% of adults with obesity also have elevated cholesterol levels, many of these individuals never reach healthy levels for their cholesterol, highlighting a key gap for many patients who are managing cardiometabolic conditions.
    • “Omada for Cholesterol will bring its artificial-intelligence-powered and human-led coaching approach to cholesterol management and embed it within the broader platform for managing weight, blood pressure and diabetes.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports from its Cybertalks event held earlier this week.
    • “Department of Health and Human Services official said Thursday that HHS is devoting a lot of attention to the security of third-party service providers after the 2024 Change Healthcare cyberattack.
    • “That attack, which is widely regarded as the biggest ever in the sector — including by HHS’s Charlee Hess, who spoke Thursday at CyberTalks presented by CyberScoop — began with hackers exploiting the lack of multifactor authentication set up on a remote access portal at Change Healthcare.
    • “It wasn’t a hospital, it was a company most people have never heard of and had major impacts on our sector and threatened the liquidity of our entire health care system,” said Hess, director of the healthcare and public health sector cybersecurity at the Administration for Strategy Preparedness and Response division. “We recovered from that, but we realized there are third-party risks lurking in our health care system, and we don’t even know they’re there. Where are those entities or systems that will have an outsized impact on our sector?”
  • and
    • “A top FBI cyber official said Salt Typhoon, the Chinese cyber espionage group behind the widespread compromise of U.S. telecommunications infrastructure in 2024, continues to pose a broad threat to both America’s private and public sectors.
    • “Michael Machtinger, deputy assistant director for cyber intelligence at the FBI, touted improved partnerships between the telecommunications industry and government in the wake of the campaign while speaking at CyberTalks, presented by CyberScoop, in Washington D.C. Thursday.
    • Companies who engaged with the FBI and federal agencies like CISA early after the campaign went public “have been without a doubt the most successful in mitigating the impact of the Salt Typhoon intrusions,” he claimed.”
  • and
    • “The Trump administration wants to boost the use of artificial intelligence for security in a way that doesn’t increase the number of targets for adversaries to attack, a top official with the Office of the National Cyber Director said Thursday.
    • “The administration will “promote the rapid implementation of AI enabled cyber defensive tools to detect, divert and deceive threat actors who continue targeting our vital systems and sectors,” Alexandra Seymour, principal deputy assistant cyber director for policy, said at CyberTalks, presented by CyberScoop. “We want to ensure that as Americans, companies and agencies deploy AI to defend themselves, they are not inadvertently making themselves more vulnerable by widening the attack surface.”
    • “Overall, “We’re working with our interagency and White House colleagues to promote AI-driven success while addressing concerns about AI security and countering AI abuse by adversaries,” she said.
    • “The focus on AI is expected to get further attention from a forthcoming national cyber strategy and the implementation of that strategy due to follow.”
  • Federal News Network adds,
    • “The National Institutes of Standards and Technology is launching a new project around standards for artificial intelligence agents, with NIST positioning the project as key to advancing agentic AI innovation.
    • “NIST’s Center for AI Standards and Innovation (CAISI) announced the “AI Agent Standards Initiative” this week. The project aims to foster “industry-led technical standards and protocols that build public trust in AI agents, catalyze an interoperable agent ecosystem, and diffuse their benefits to all Americans and across the world,” NIST said in a release this week.
    • “AI agents can now work autonomously for hours, write and debug code, manage emails and calendars, and shop for goods, among other emerging use cases,” NIST added. “While the productivity promise is enticing, the real-world utility of agents is constrained by their ability to interact with external systems and internal data. Absent confidence in the reliability of AI agents and interoperability among agents and digital resources, innovators may face a fragmented ecosystem and stunted adoption.”
    • While NIST’s press release positioned the project around innovation, the initiative’s opening products are centered on security. Since AI agents can take actions autonomously, tech experts say they present significant safety and security concerns.
    • “The initiative’s initial outputs includes a request for information on “AI agent security.” The deadline for responses to the RFI is March 9.”
  • Per February 19, 2026, HHS news release,
    • “[T]he U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced a settlement with Top of the World Ranch Treatment Center (TWRTC), a substance use disorder treatment provider in Illinois, for a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.” * * *
    • “The settlement resolves an investigation of TWRTC that OCR initiated after receiving a breach report that TWRTC filed in March 2023. TWRTC reported that, as a result of a successful phishing attack, an unauthorized third party accessed ePHI through a workforce member’s email account. TWRTC concluded that the ePHI for 1,980 patients was compromised by the attack. OCR’s investigation found evidence that TWRTC failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI TWRTC holds as required by the HIPAA Security Rule.
    • “Under the terms of the resolution agreement, TWRTC agreed to implement a corrective action plan that OCR will monitor for two years, and paid $103,000 to OCR.” * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-ra-cap-twrtc.pdf [PDF, 249 KB]“
  • Cyberscoop reports,
    • “A Ukrainian national who ran multiple operations to aid the North Korean government’s expansive scheme to  hire remote IT workers at U.S. companies was sentenced to five years in prison, the Justice Department said Thursday.
    • “Oleksandr Didenko stole U.S. citizens’ identities and created more than 2,500 fraudulent accounts on freelance IT job forums, money service transmitters, email services, and social media platforms to sell the proxy identities to North Korean workers. The 29-year-old pleaded guilty to multiple crimes related to the six-year scheme in November 2025.” * * *
    • “U.S. law enforcement has racked up some wins by seizing stolen cryptocurrency and targeting U.S.-based facilitators who provide forged or stolen identities for North Korean operatives. 
    • “Yet, the regime’s scheme runs deep. North Korean nationals have infiltrated many top global companies, and researchers continue to uncover evidence of new tactics and techniques operatives have used to evade detection.”

From the cybersecurity vulnerabilities and breaches front,

  • Bleeping Computer tells us,
    • “PayPal is notifying customers of a data breach after a software error in a loan application exposed their sensitive personal information, including Social Security numbers, for nearly 6 months last year.
    • “The incident affected the PayPal Working Capital (PPWC) loan app, which provides small businesses with quick access to financing.
    • “PayPal discovered the breach on December 12, 2025, and determined that customers’ names, email addresses, phone numbers, business addresses, Social Security numbers, and dates of birth had been exposed since July 1, 2025.
    • “The financial technology company said it has reversed the code change that caused the incident, blocking attackers’ access to the data one day after discovering the breach.
    • “On December 12, 2025, PayPal identified that due to an error in its PayPal Working Capital (“PPWC”) loan application, the PII of a small number of customers was exposed to unauthorized individuals during the timeframe of July 1, 2025 to December 13, 2025,” PayPal said in breach notification letters sent to affected users.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added eight known exploited vulnerabilities to its catalog during this shutdown week.
    • February 17, 2026
      • CVE-2008-0015 Microsoft Windows Video ActiveX Control Remote Code Execution Vulnerability
      • CVE-2020-7796 
      • CVE-2024-7694 TeamT5 ThreatSonar Anti-Ransomware Unrestricted Upload of File with Dangerous Type Vulnerability
      • CVE-2026-2441 Google Chromium CSS Use-After-Free Vulnerability
        • Cybersecurity News discusses the MS Windows KVe here.
        • The Hacker News discusses the other three KVEs here.
    • February 18, 2026
      • CVE-2021-22175 GitLab Server-Side Request Forgery (SSRF) Vulnerability
      • CVE-2026-22769 Dell RecoverPoint for Virtual Machines (RP4VMs) Use of Hard-coded Credentials Vulnerability
        • DeV discusses the Gitlab KVE here.
        • Bleeping Computer discusses the Dell KVE which demands immediate attention.
    • February 20, 2026
      • CVE-2025-49113 RoundCube Webmail Deserialization of Untrusted Data Vulnerability
      • CVE-2025-68461 RoundCube Webmail Cross-site Scripting Vulnerability
        • The Hacker News discusses these KVEs here.
  • Cybersecurity Dive reports,
    • “A critical vulnerability in BeyondTrust Remote Support is facing an increase in threat activity, with hackers deploying SparkRAT and vShell backdoors and using remote management tools to conduct reconnaissance, according to a blog post released Thursday by Palo Alto Networks’ Unit 42. 
    • “Multiple BeyondTrust Remote Support users have been confirmed targets, and a range of industries have been impacted, including financial services, technology, higher education, legal services and healthcare among others. 
    • “The vulnerability, tracked as CVE-2026-1731, is an operating system command injection flaw that also impacts some older versions of BeyondTrust Privileged Remote Access. 
    • “The flaw was originally discovered by researchers at Hacktron and disclosed to BeyondTrust.”
  • Per an HHS announcement,
    • “The Department of Health and Human Services (HHS) encourages Healthcare and Public Health (HPH) sector organizations to review and address a critical vulnerability identified in BeyondTrust Remote Support and Privileged Remote Access solutions in light of rising cyber attacks affecting the sector.
    • “BeyondTrust published Security Advisory BT26-02 regarding a critical pre-authentication remote code execution vulnerability, identified as CVE-2026-1731, affecting Remote Support and older versions of Privileged Remote Access. The vulnerability carries a CVSSv4 score of 9.9 and may be triggered through specially crafted client requests, potentially allowing an unauthenticated remote attacker to execute operating system commands in the context of the site user. 
    • “The vulnerability affects Remote Support version 25.3.1 and prior and Privileged Remote Access version 24.3.4 and prior, with remediation available through specific patches or by upgrading to fixed versions. BeyondTrust issued patches on February 2, 2026, which were automatically deployed to instances with the update service enabled and fully applied to Software as a Service environments. BeyondTrust applied patches to all SaaS customers as of February 2, 2026, and instructed self-hosted customers to manually apply updates or upgrade to supported versions where necessary. For additional information, organizations are encouraged to review the BeyondTrust Security Advisory.”
  • Dark Reading relates,
    • “New data suggests a cyber espionage group is laying the groundwork for attacks against major industries.
    • “The “React2Shell” vulnerability is already almost a few months old, but it’s far from over. An unknown but possibly state-sponsored threat actor has been using a newly discovered, maturely named toolkit — “ILovePoop” — to probe tens of millions of Internet protocol (IP) addresses worldwide, looking for opportunities to exploit React2Shell. A report from WhoisXML API, shared with Dark Reading, suggests the threat actor might be out for big game: government, defense, finance, and industrial organizations, among others, around the world but particularly in the United States.
    • “A few months later, the situation has yet to calm down, Pham says. “There are still tens of thousands of vulnerable instances exposed on the internet, and additional botnets have added React2Shell to their arsenals. It has also been confirmed in ransomware campaigns,” she says. 
    • The big difference now is that the attacks have gotten more sophisticated, as the attackers have had more time to gameplan. “The post-exploitation tradecraft has gotten more sophisticated over time. We are seeing things like PeerBlight’s use of the BitTorrent DHT as a resilient C2 fallback, which is a technique designed specifically to survive traditional domain takedowns,” Phams says.” * * *
    • “Patching a deep-rooted vulnerability like React2Shell isn’t as simple as clicking an “Update” button.”
  • and
    • “When Hillai Ben Sasson and Dan Segev set out to hack AI infrastructure two years ago, they expected to find vulnerabilities — but they didn’t expect to compromise virtually every major AI platform they targeted.
    • “The two researchers — who work in offensive and defensive research, respectively, at cloud-security firm Wiz — wanted to experiment with how they could attack the AI infrastructure being deployed as part of foundational models, AI services, and in-house AI projects. Yet, what started as simple attacks on the AI supply chain — such as abusing the widely used Pickle format to run arbitrary code — evolved into a comprehensive threat assessment spanning five distinct layers of the AI stack.
    • “They plan to present the lessons learned over their two years of research at the upcoming RSAC Conference in March. Perhaps the most important lesson: Focus on the infrastructure used to to train, run, and host AI services, and not on prompt-injection attacks, says Segev, a security architect in the Office of the CTO at Wiz.”
  • and
    • “A growing phishing-as-a-service (PhaaS) tool reliably undermines traditional methods for detecting phishing attacks, both technical and psychological.
    • “Starkiller,” described this week by researchers at Abnormal AI, is packaged and sold with a sleekness comparable to legitimate software-as-a-service (SaaS) platforms. It’s got a clean, retrofuturist dashboard, sporting real-time campaign analytics. It gets periodic updates, and even allows its cybercriminal users to log in using two-factor authentication (2FA).
    • “It’s got substance to back up its style, too. Its website advertises “enterprise-grade phishing infrastructure” for “campaigns that bypass modern security systems.” Though its self-reported 99.7% success rate is almost certainly fictional, it really does help attackers bypass many of the traditional phishing security techniques so many enterprises rely on, according to Abormal AI’s research.”
  • Cybersecurity Dive notes,
    • “The vulnerability of the “connective tissue” of the AI ecosystem — the Model Context Protocol and other tools that let AI agents communicate — “has created a vast and often unmonitored attack surface” that is making it easier for hackers to use AI to launch cyberattacks, Cisco said in a report published Thursday [February 19].
    • “Cisco said AI tools’ increasing ability to “execute processes, access databases, and push code on behalf of humans” has become the dominant AI risk and warned companies not to give AI “unsupervised control over critical business functions.”
    • “The new report also described nation-state hackers’ use of AI and warned businesses about potential AI supply-chain crises.”

From the ransomware front,

  • Bleeping Computer reports,
    • “The University of Mississippi Medical Center (UMMC) closed all its clinic locations statewide on Thursday [February 19] following a ransomware attack.
    • “UMMC has over 10,000 employees and, as one of the largest employers in Mississippi, operates seven hospitals, 35 clinics, and more than 200 telehealth sites statewide. The medical center includes the state’s only children’s hospital, only Level I trauma center, only organ and bone marrow transplant program, and the only Telehealth Center of Excellence, one of two across the United States.
    • “As revealed on Thursday afternoon, the cyberattack took down many of its IT systems and blocked access to the Epic electronic medical records. While UMMC cancelled outpatient and ambulatory surgeries/procedures and imaging appointments, officials said hospital services continue via downtime procedures.”
  • The HIPAA Journal points out ransomware attacks against three other healthcare entities.
    • “Issaqueena Pediatric Dentistry in South Carolina, Enhabit Home Health & Hospice in Texas, and AltaMed Health Services in California have announced that patient data has potentially been compromised in ransomware attacks.”
  • Per an Arctic Wolf news release,
    • “Arctic Wolf®, a global leader in security operations, today [February 17] published the 2026 edition of its Threat Report, which analyzes hundreds of real‑world incident response engagements and threat intelligence findings from the past year. The report reveals a continued rise in data‑theft‑driven extortion, sustained pressure from ransomware groups, and a significant increase in attacks that leverage remote access tools rather than technical exploits.
    • “In 2025, ransomware, business email compromise (BEC), and data incidents once again dominated Arctic Wolf’s caseload, accounting for 92% of all incident response engagements. While ransomware remained the most common category, data‑only extortion incidents surged 11x year over year, signaling a strategic shift as threat actors adapt to improved organizational recovery capabilities. The report also finds that 65% of non‑BEC intrusions stemmed from abuse of remote access technologies like RDP, VPN, and RMM tools; which is a dramatic rise that underscores attackers’ preference for low‑friction entry points.
    • “Attackers continue to rely on operational efficiency – logging in instead of breaking in, stealing data instead of encrypting it, and exploiting trusted tools rather than complex vulnerabilities,” said Ismael Valenzuela, vice president, Labs, Threat Research & Intelligence, Arctic Wolf. “Organizations that invested in visibility, identity security, and disciplined remote access controls were far more resilient throughout the year.”
  • Cybersecurity Dive adds,
    • “Hackers are using ransomware to accelerate the timeline for cyberattacks, moving on average four times faster than just a year ago, according to an incident response report released Tuesday by Palo Alto Networks. 
    • “AI is being used for reconnaissance, phishing and scripting, and operational execution in many cases. In the most efficient attacks, groups exfiltrate data just 72 minutes after initial access. 
    • Identity is a primary element in attacks, showing up in 90% of incident response cases. Threat groups are increasingly using stolen identities and tokens to gain entry without triggering security warnings.  
    • “Once an attacker has legitimate credentials, they’re not breaking in, they’re logging in,” Sam Rubin, a senior vice president at Palo Alto Networks’ Unit 42, told Cybersecurity Dive. “When an adversary blends into normal traffic, detection becomes incredibly challenging for even mature defenders.”
    • “The report is based on analysis of more than 750 incident response casesacross the globe that involved Unit 42 analysts and researchers.” 
  • Qualsys assesses “What Is Black Basta Ransomware and How to Mitigate Attack.”
  • IT Brew considers how a ransomware attacker thinks.
    • “When it comes to ransomware criminals, the answers can vary. Some organizations are sophisticated businesses where hackers are treated as employees with HR departments and paid time-off, while others are more ramshackle.
    • “But they’re all dangerous—and after your data. Mike Puglia, general manager of cybersecurity labs at Kaseya, told IT Brew that financial motivation has been the constant motive of ransomware attackers. The tactics are much the same between groups: gaining access, exploiting vulnerabilities, escalating privileges, and deploying an encrypter to hold the data for payment.
    • “It’s Whac-a-Mole, or a game of cat and mouse, between defenders and attackers, and as soon as one hole is closed, suddenly the next wave comes,” Puglia said.”
  • Per an HHS announcement,
    • “The National Institute of Standards and Technology (NIST) hosted a virtual event titled Resources for Ransomware Risk Management on January 28, 2026. The event focused on ransomware as a persistent risk to organizations of all sizes and sectors and emphasized the need for cross-sector collaboration to develop practical resources for reducing ransomware risk. Speakers from NIST, the Center for Internet Security, and the Institute for Security and Technology (IST) provided an overview of available ransomware risk management resources designed to help organizations establish foundational safeguards and build effective strategies. Featured resources included the NIST Ransomware Risk Management Cybersecurity Framework 2.0 Community Profile, published as an initial public draft, and the IST and Ransomware Task Force Blueprint for Ransomware Defense, which offers an actionable framework tailored for small to medium-sized enterprises. Presenters described the development and use of these resources and discussed ongoing and future efforts in ransomware risk management, with the session allowing time for audience questions and discussion. For additional details, refer to the Ransomware Risk Management webinar.”

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Palo Alto Networks PANW lifted its full-year revenue outlook after recording a jump in second-quarter profit driven by continued demand for cybersecurity services.
    • “However, the company issued per-share earnings guidance for its current quarter below Wall Street expectations, in part as it contends with higher costs for memory and storage. It plans to raise prices later in the fiscal year to offset the increases.
    • “The stock, which has dropped 11.2% to start the year, fell 8% in late trading Tuesday to $150.46.
    • “The Santa Clara, Calif.-based company on Tuesday [February 17] said it now expects full-year revenue to come in between $11.28 billion and $11.31 billion, up from a range of $10.5 billion to $10.54 billion.
    • “The raised revenue view came after Palo Alto reported a profit of $432 million, or 61 cents a share, for its fiscal second quarter, compared with a profit of $267.3 million, or 38 cents a share the prior year.”
  • Cybersecurity Dive adds,
    • “As investors worry that existing software and services could be rendered obsolete, Palo Alto Networks CEO Nikesh Arora said the rapid acceleration of AI should not be considered a threat to cybersecurity. 
    • “Arora addressed the concerns on Tuesday during the company’s fiscal second-quarter conference call, where the surge in AI dominated much of the discussion. 
    • “As AI becomes more pervasive across the enterprise, it expands the attack surface area, more infrastructure, more machine-to-machine activity and new classes of risk that simply didn’t exist before,” Arora said. “In that environment, security cannot sit on the sidelines.”
    • “Arora said despite the current sentiment about software and AI, the company believes that security is the enabling layer “that allows innovation to move forward safely and at scale.”
  • and
    • “Businesses need to pay attention to identity security and third-party risk management to avoid falling prey to hackers whose techniques have evolved, the risk intelligence company Dataminr said in a threat report published on Wednesday [February 18].
    • “2025 marked a clear shift from ‘frequent but contained’ cyber losses toward fewer events with materially larger financial and mission impact,” the report said, attributing the shift to “multi-vector attacks” leveraging stolen credentials, data theft, operational disruptions and regulatory exposure.
    • “Dataminr’s report contains several high-priority recommendations for enterprises, including about supply chain security and the need to look beyond a vulnerability’s severity score.”
  • Dark Reading offers “A CISO’s Playbook for Defending Data Assets Against AI Scraping.”
    • “Discover a strategic approach to govern scraping risks, balance security with business growth, and safeguard intellectual capital from automated data harvesting.”
  • Cyberscoop relates,
    • “Anthropic is rolling out a new security feature for Claude Code that can scan a user’s software codebases for vulnerabilities and suggest patching solutions.
    • “The company announced Friday that Claude Code Security will initially be available to a limited number of enterprise and team customers for testing. That follows more than a year of stress-testing by the internal red teamers, competing in cybersecurity Capture the Flag contests and working with Pacific Northwest National Laboratory to refine the accuracy of the tool’s scanning features.
    • “Large language models have shown increasing promise at both code generation and cybersecurity tasks over the past two years, speeding up the software development process but also lowering the technical bar required to create new websites, apps and other digital tools.
    • “We expect that a significant share of the world’s code will be scanned by AI in the near future, given how effective models have become at finding long-hidden bugs and security issues,” the company wrote in a blog post.”
  • Tech Target shares a “CISO’s guide to demonstrating cyber resilience.”
    • “Elevating cybersecurity to a state of resilience requires a security team to adapt and strengthen defenses. The result should be that a future attack is less likely to succeed.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NCQA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Govexec.com reports,
    • “While the Homeland Security Department is shut down, the vast majority of employees—about 92%—are still reporting to work. In some cases, however, workers are finding creative solutions to get out of their regular duties and save money while their paychecks hang in the balance. 
    • “My unit is rotating voluntary furlough days,” said one DHS staffer.  “Workers in that office are taking turns to take time off work, which, during a shutdown, entails being placed in an unpaid furlough status. 
    • “[We] conserve finances by not commuting, since we’re only allowed to telework in emergency situations,” the employee said, noting some employees in the unit commute 80 miles per day and are therefore seeing significant savings on gas when they do not go to work. The employees who accept the furloughs have used the time to schedule medical appointments, handle errands or tackle home projects.” * * *
    • “Most DHS employees will not miss a full paycheck until the beginning of March. Craig Carter, president of the Federal Managers Association, said the impacts are already being felt across the DHS workforce.” 
  • The OPM Office of Inspector General has posted its semi-annual report to Congress for the period ended September 30, 2025. Here is a link to the OPM management’s response to this report.
  • Legistorm tells us about GAO report number GAO-26-107169 which was issued yesterday.
    • “What GAO Found
      • “The No Surprises Act, among its provisions, generally prohibits providers from balance billing in certain circumstances—such as emergency services—for individuals with private health insurance. Balance billing is when insured patients receive a bill from an out-of-network health care provider for the amount above any applicable cost-sharing that exceeds the health plan or issuer’s payment. An unexpected balance bill is referred to as a surprise bill.
      • “GAO analyzed the percentage of claims that were in-network for selected specialties to examine potential changes in network participation after the act’s implementation. Increases in the percentage of in-network claims may indicate increases in provider participation, while decreases may indicate reduced participation.
      • “Among specialties likely to be affected by the No Suprises Act protections—emergency medicine, radiology, anesthesiology, and air ambulance—the percentage of in-network claims increased for three of the four specialties after the act took effect. For example, GAO found the percentage of in-network facility claims (typically submitted by hospitals) and professional claims (typically submitted by physicians) for emergency medicine declined before the No Surprises Act took effect, then increased afterward.
      • “Payment changes for the selected services largely reflected continuations of trends prior to the No Surprises Act taking effect. For example, the inflation-adjusted payment for in-network emergency medicine services billed by facilities increased in 2022 and 2023, continuing the trend since 2019. Meanwhile, the inflation-adjusted payment for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends.”
    • FEHBlog note: This is encouraging news.
  • NCQA writes in LinkedIn
    • “NCQA has updated its State of Health Care Quality Report to include data for HEDIS® Measurement Year (MY) 2024. This free resource, available on the NCQA website, offers valuable insight into healthcare quality performance nationwide.
    • “You can use this report to:
      • “Learn more about each quality measure, how it is defined and why it matters.
      • “Access national averages and historical trends for over 90 measures of clinical quality and patient satisfaction.
      • “Compare performance across different products, like Commercial, Medicare and Medicaid.
      • “We will add data for MY 2025 in February 2027, or you can get it sooner through NCQA’s Quality Compass®.
    • “The report is available through this link. You can also find a link to the report on the HEDIS Measures and Technical Resources web page.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV.
    • “Høeg told employees on Thursday that her top priorities include two issues she’s focused on in the recent past: evaluating the safety of antidepressants taken by pregnant women and of monoclonal antibodies that protect infants against RSV.
    • “I’ve been interested to learn we really haven’t been doing sort of thorough safety monitoring of these products during pregnancy, and so I think we could do a better job,” Høeg said. “I actually think that there’s agreement about that, and among the CDER staff that I’ve been working with on this issue, so I’m excited to see that.”
    • “Høeg also discussed her interest in vaccine policy, and mentioned she’d like to “bring that interest” into the drug center.”
  • Radiology Business relates,
    • “GE HealthCare has secured three notable new MRI clearances from the U.S. Food and Drug Administration. 
    • “On Thursday, the company announced the clearance of two MRI systems, Signa Sprint with Freelium and Signa Bolt, and one artificial intelligence-enabled workflow platform. Each of the three cleared produts were designed with the rising demand for MR imaging in mind, according to the company’s president and CEO of MR, Kelly Londy. 
    • “Achieving FDA clearance of our next-generation Signa MRI technology underscores our commitment to expanding access to high-quality imaging and elevating the standard of care for patients everywhere,” Londy said in an announcement. “As MRI demand continues to rise across clinical areas, providers need solutions that deliver greater efficiency without compromising diagnostic precision.”
  • BioPharma Dive informs us,
    • “Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.  
    • “Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the “adjuvant” setting after surgery. 
    • “If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.”

From the judicial front,

  • The American Hospital Association News reports,
    • The Supreme Court Feb. 20 ruled [in a 6-3 opinion written by the Chief Justice] that the International Emergency Economic Powers Act [of 1977] does not authorize the imposition of global tariffs. The court held that IEEPA does not provide the president with “the independent power to impose tariffs on imports from any country, of any product, at any rate, for any amount of time.” The court did not address whether the government will have to refund the tariff revenue or what other legal authorities the president may have to impose similar tariffs. [The Court remanded those decisions to the lower courts.]
  • Bloomberg Law reports,
    • “The FTC has asked a federal appeals court to revive requirements for companies to divulge more information to US antitrust regulators ahead of potential mergers.
    • “The Federal Trade Commission Wednesday appealed a Feb. 12 decision from a US district court judge in Texas blocking a 2024 Biden-era rule. The case is pending in the US Court of Appeals for the Fifth Circuit.
    • “The regulation updated a decades-old US pre-merger notification program to require companies share more about overlapping business lines and ownership structures, among other details. Companies seeking combinations valued at $133.9 million or more must undergo an initial 30-day review by the FTC and Justice Department under the notice system.”
  • and
    • “The [U.S. Court of Appeals for the] First Circuit rejected a lawsuit accusing Cigna Health & Life Insurance Co. of obesity discrimination, shutting down an attempt to broaden coverage of blockbuster GLP-1 weight-loss drugs.
    • “Pressure to cover the drugs is growing for insurers and employers as their uptake among the general public increases. One in five adults has taken a GLP-1 drug at some point, according to a November 2025 poll from health-care think tank KFF.
    • “The US District Court for the District of Maine previously dismissed Jamie Whittemore’s case, along with a similar case against Elevance Health Inc. The district judges determined that Whittemore didn’t prove that obesity qualified her as disabled.” * * *
    • “Here, even if Whittemore plausibly alleged that obesity is a physical impairment, she failed to allege sufficient facts to support an inference that her obesity substantially limits her major life activities,” Judges Lara E. Montecalvo, Sandra L. Lynch, and Ojetta Rogeriee Thompson wrote in their opinion Thursday.”
  • Per a Justice Department news release,
    • “The Justice Department’s Antitrust Division, together with the Attorney General of Ohio, filed a civil antitrust lawsuit today challenging OhioHealth Corporation’s (OhioHealth) anticompetitive contract restrictions that force Ohio patients to pay higher prices for healthcare.
    • “The complaint, filed in the U.S. District Court for the Southern District of Ohio, seeks to enjoin OhioHealth, the largest healthcare system in central Ohio, from enforcing its anticompetitive contractual terms and continuing to suppress healthcare competition.”
  • Per Beckers Payer Issues,
    • “An insurance brokerage president and the CEO of a marketing company were each sentenced to 20 years in prison for their roles in a scheme to fraudulently enroll individuals in subsidized ACA plans to obtain commission payments from insurers.”

From the public health, medical and Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Seasonal influenza activity remains elevated nationally. RSV activity is elevated and increasing in some areas of the country. Emergency department visits for RSV are highest among infants and children less than 4 years old. RSV hospitalizations are highest among infants and children less than 4 years old. 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
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing while influenza B activity is increasing nationally and in most areas of the country; however, trends vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is elevated in many areas of the country, including emergency department visits among infants and children 4 years and younger. Hospitalizations are highest among infants less than 1 year old.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remains low for children and adults. COVID-19, influenza, and RSV vaccines can provide protection against severe disease this season. It is not too late to get vaccinated this season. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • Per the AHA News,
    • “The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a population at high risk of severe illness from the disease. The report found that from June 2023 through September 2025, 16%-23% of COVID-19 patients older than 65 received an antiviral prescription during low occurrences of COVID-19, compared to 37%-38% during higher occurrences. Adults ages 75-84 and 85 and older were more likely to receive an antiviral prescription than those ages 65-74. “COVID-19 vaccination and treatment can prevent severe COVID-19 among older adults,” the CDC wrote. “Efforts to improve health care provider and patient knowledge regarding the benefits of COVID-19 vaccination and antivirals, especially for older adults, are needed to reduce the risk for severe illness and death.”
  • The University of Minnesota’s CIDRAP adds,
    • “Two studies examined the effects of COVID-19 vaccination in pregnancy, with one estimating that full vaccination and a booster dose reduce the risk of preeclampsia (PE) by 15% and 33%, respectively, and the other finding no elevated risk of miscarriage before 20 weeks’ gestation among pregnant or soon-to-be-pregnant recipients of the Pfizer/BioNTech or Moderna vaccines.”
  • The CDC also announced,
    • “As of February 19, 2026, 982 confirmed* measles cases were reported in the United States in 2026. Among these, 976 measles cases were reported by 26 jurisdictions: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Minnesota, Nebraska, New York City, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin. A total of 6 measles cases were reported among international visitors to the United States. 
    • “There have been 7 new outbreaks** reported in 2026, and 89% of confirmed cases (870 of 982) are outbreak-associated (73 from outbreaks starting in 2026 and 797 from outbreaks that started in 2025).”
  • The University of Minnesota’s CIDRAP adds,
    • “Utah has confirmed 300 measles cases in an ongoing outbreak, with the virus now spreading in Salt Lake County and new exposures at high schools in that county, according to an update yesterday from the Salt Lake County Health Department (SLCoHD).
    • “The first measles symptoms are often cold- or flu-like, with cough, runny nose, red/watery eyes, and fever, so you may think you have a common respiratory illness and can continue engaging in normal activities,” said Dorothy Adams, executive director of SLCoHD. “But please stay home if you have any signs of illness, especially now that we know measles is actively circulating in our community.”
  • Per the AHA News,
    • “The ongoing measles outbreak in South Carolina has reached 973 cases, the state’s Department of Public Health reported Feb. 20. Of those, 906 cases are unvaccinated, 26 are fully vaccinated, 20 are partially vaccinated and the vaccination status of 21 cases is unknown. Nationally, 982 confirmed measles cases across 26 jurisdictions have been reported to the Centers for Disease Control and Prevention since Jan. 1. The CDC said there have been seven outbreaks reported in 2026 and that 89% of confirmed cases are outbreak-associated.” 
  • Cardiovascular Business informs us,
    • “The American College of Cardiology (ACC) and American Heart Association (AHA) have developed their first clinical practice guidelines focused on the treatment and management of acute pulmonary embolism (PE). The new document, published in full in JACC and Circulation, highlights the importance of diagnosing patients as quickly as possible and determining the best course of action.
    • “A PE is a potentially fatal blood clot that travels through the heart and then becomes lodged in an artery in the lungs. Treating PEs quickly—and effectively—can help minimize the patient’s risk of death and cardiac arrest. Anticoagulants are the most common PE treatment, but catheter-based interventions and surgery may be necessary for more severe cases.
    • “There have been significant advances in the understanding of PE and treatments to effectively manage this condition,” Mark A. Creager, MD, chair of the document’s writing committee and director emeritus of the Heart and Vascular Center at Dartmouth Health, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”
  • Per Radiology Business,
    • “New research highlights the potential for a PET- and MRI-based imaging approach for differentiating a new type of dementia from Alzheimer’s disease. 
    • “Limbic-predominant age-related TDP-43 encephalopathy, also known as LATE, was recently recognized as a type of dementia that occurs in older adults, typically presenting as memory-related cognitive decline. Due to its impact on memory, it is often mistaken for AD. 
    • “However, both LATE and Alzheimer’s present differently on imaging. While AD is identified due to the accumulation of amyloid and tau proteins on the brain, LATE involves clumps of the protein TDP-43 in the limbic system. It is important to differentiate between the two due to the differing treatment methods for each. 
    • ‘A new paper in the Journal of Nuclear Medicine describes how combining PET and MRI imaging data can help distinguish between the two in living patients. 
    • “The distinction in the causes of these types of dementia is critical, especially in the era of anti-amyloid therapies,” Satoshi Minoshima, MD, PhD, professor of radiology and imaging sciences at the University of Utah, Salt Lake City, said in a news release. “Because LATE has a different underlying pathology and a seemingly different prognosis, it cannot be diagnosed or treated in the same way as Alzheimer’s disease.” 
  • The University of Connecticut, the FEHBlog’s alma mater, writes in LinkedIn about research on Parkinson’s Disease treatments.
  • Per BioPharma Dive,
    • “Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading.
    • “The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
    • “Grail said the study aimed to show testing could help reduce late-stage cancer diagnoses and increase detection rates to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.”
  • Per Health Day,
    • “An ancient Chinese mind-body practice can lower a person’s blood pressure as well as medication or a program of brisk walking, a new study says.
    • “Baduanjin is a widely practiced eight-movement sequence that combines slow, structured movement, deep breathing and meditation.
    • “The practice lowered people’s blood pressure by about 3 to 5 points, similar to benefits sustained by people asked to take up walking, according to clinical trial results published Feb. 18 in the Journal of the American College of Cardiology.”
  • Per Genetic Engineering and Biotechnology News,
    • “Stanford Medicine researchers and collaborators have developed a universal vaccine candidate that studies in mice suggest protects against a wide range of respiratory viruses, bacteria, and even allergens. Unlike any vaccine used today, the new vaccine, delivered intranasally, was found to provide broad protection in the lungs for several months. The novel vaccination strategy integrates the two branches of immunity—innate and adaptive—creating a feedback loop that sustains a broad immune response.
    • “The research team, headed by Bali Pulendran, PhD, the Violetta L. Horton Professor II, director of the Institute for Immunity, Transplantation and Infection, and a professor of pathology, microbiology and immunology at Stanford University, demonstrated that vaccinated mice were protected against SARS-CoV-2 and other coronaviruses,  Staphylococcus aureus and Acinetobacter baumannii (common hospital-acquired infections), and house dust mite allergen. Pulendran said the new vaccine has worked for a remarkably wide spectrum of respiratory threats that the researchers tested. Speaking to GEN, Pulendran emphasized that the reported work is preclinical, and the team’s goal is to translate their research carefully and responsibly. “If it ultimately proves safe and effective in humans, the potential impact could be transformative: simplifying seasonal vaccination and improving readiness for emerging respiratory threats,” Pulendran said.”

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

  • Beckers Payer Issues reports,
    • “Medicare Advantage now covers about 55% of eligible beneficiaries nationwide — more than 35 million people — but health systems are confronting a question that until recently felt almost taboo: What happens when participation in the country’s fastest-growing Medicare program no longer makes financial sense?
    • “Over the past three years, Becker’s has reported on roughly 90 hospitals and health systems that have terminated some or all of their commercial Medicare Advantage contracts. In 2026 alone, at least 15 systems have gone out of network with one or more Medicare Advantage plans, and the trend is showing no signs of slowing down. 
    • ‘This year, 1 in 10 Medicare Advantage enrollees — about 2.9 million people — will be forced to disenroll from their plan following a spike in plans exiting the market, according to a Feb. 18 study published in JAMA.
    • “Behind many of those decisions lies what Scripps Health CFO Brett Tande describes as a classic “sunk-cost” dilemma: after years of building infrastructure, staffing and strategy around Medicare Advantage, can systems realistically walk away — even when contracts are losing money?
    • “For a growing number of health systems, the answer is becoming clearer.
    • “Becker’s connected with executives from Providence, Scripps Health, Ascension, MemorialCare and Mayo Clinic to understand how they are reassessing their participation in Medicare Advantage and what that shift could mean for providers, payers and patients.”
  • Kaufmann Hall notes,
    • “Partnerships, like all relationships, are de facto collaborative. Certain success factors are well known, including the importance of cultural alignment, constant communication and effective post-closing integration. Based on our collective experience assisting health systems with the negotiation of strategic partnerships, we share other lessons learned that are important considerations. These are tangible steps that require intentional focus and may require hard choices during the partnership development process but are important for ensuring long-term success. We hope these “inside baseball” lessons and case studies are useful for organizations when negotiating their next strategic partnership.”
  • and
    • “Amazon last week announced it would expand its same-day pharmacy delivery service to 4,500 cities nationwide. The move expands Amazon’s market share against other drug delivery providers like Walmart and CVS Caremark. It adds same-day delivery services to 2,000 communities, including remote areas in Alaska, the Navajo Nation and islands only accessible by ferry and only navigable by horse-drawn carriage. The expansion demonstrates the retail giant’s ability to scale its logistics network in healthcare, offering faster access to medications compared with traditional mail-order pharmacies, which can take up to 10 days to deliver drugs.”
  • Behavioral Health Business relates,
    • “Madison Health Group (MHG) has announced its plans to purchase managed behavioral health provider Magellan Health.
    • “This comes roughly five years after payer giant Centene Corporation (NYSE: CNC) bought Magellan Health at a valuation of $2.2 billion.
    • ​”Magellan Health manages behavioral health services for health plans, employers and government agencies.
    • ​”Following the deal, Magellan will become an independent organization, with MHG’s backing to support innovation. Specifically, the new funds will be used to expand its clinical programs into new markets, leveraging “enhanced technology, AI, data and analytical solutions” for its clients, according to social media posts.”
  • Fierce Healthcare tells us,
    • “Carrot is expanding its parenting benefits with on-demand virtual pediatric care through Blueberry Pediatrics. 
    • “Carrot, a fertility and family-building benefits platform working with payers and employers, will offer Blueberry as an add-on. The new offering will be available to families with kids under 12. It is expected to roll out in the next few months. The offering will be covered by the plan sponsor, and members are not expected to incur out-of-pocket costs.
    • ‘Parents will have 24/7 access to on-demand virtual visits with board-certified pediatricians from Blueberry for common issues like ear infections, rashes, colds and the flu. Families can connect with pediatricians around the clock via secure messaging, video or audio. Members will also get a home medical kit with a wireless digital ear scope, pediatric pulse oximeter and thermometer. This will help Blueberry clinicians remotely assess children.”
  • Per Modern Healthcare,
    • “Early lessons are emerging as the digital health sector’s ambient AI focus shifts from clinical documentation to prior authorization.
    • “Companies such as Abridge, Suki and Cohere say their solutions can do for prior authorization what ambient AI has done for documentation and clinician burnout. The importance of partnerships become an integral part of their efforts in this area.
    • “In August, Abridge announced a partnership with Pittsburgh-based insurer Highmark Health and its integrated health system Alleghany Health Network to develop a tool that would approve prior authorization requests at the point of care. Prior authorization was the logical next step for Abridge after clinical documentation, said Clinical Strategy Principal Matt Troup.
    • “Six months in, the collaboration has shown the importance of building connections with providers and payers when developing ambient AI for prior authorization.
    • “[Our partnership] just gave us access to bring everyone to the table, to figure out, what we can possibly do in this space,” Troup said. “Is it actually possible to get these approvals in real-time, upstream in the conversation, if both the payer and provider are aligned on the impact that this can have in healthcare.” 

Thursday report

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC

  • The U.S. Office of Personnel Management promulgated a final rule
    • to amend its career and career-conditional employment regulations. The revision is necessary to implement section 1108 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019, which requires OPM to issue regulations implementing hiring authorities that allow agencies to hire certain post-secondary students into positions at specified grades in the competitive service. The intended effect of the authority is to provide additional flexibility in hiring eligible and qualified individuals.
  • Federal News Network adds,
    • “Some senior political appointees, including the vice president, will continue to see a long-standing freeze on their salaries. The Office of Personnel Management announced that pay rates will continue to be capped for certain Executive Schedule employees. Political appointees in Schedules C and G, however, are exempted from the pay freeze. Certain higher-paid positions have continued to see their salary capped for more than a decade. For 2026, the pay ceiling sits at about $197,000.(Updated guidance — pay freeze for certain senior political officials – Office of Personnel Management)
  • and
    • “The Office of Personnel Management will make job offers to the first participants in the TechForce initiative as soon as March 1. OPM Director Scott Kupor said the agency is in the final stages of reviewing the applications for software engineers and data scientists to join the government for two to four years and work on specific modernization projects. Kupor said OPM will soon open up applications for cybersecurity and web design positions. OPM plans to hire 1,000 technologists to work with agencies and private sector companies to solve specific agency technology challenges.(First set of TechForce hires to come in early March – OPM)”
  • Tammy Flanagan writing in Govexec tells us, “Federal workers delay retirement as savings gaps persist.A survey shows most workers expect to retire at 65 or later, but many haven’t calculated savings for health care or emergencies.”
  • JAMA informs us,
    • “Every year over the last 2 decades, the share of Medicare beneficiaries enrolling in Medicare Advantage has increased.1 The number of plans available to Medicare Advantage beneficiaries has also increased year after year, doubling in number over the last 7 years.2 As a result, Medicare Advantage beneficiaries have rarely had to contend with disruptions resulting from Medicare Advantage plans exiting the market (forced disenrollment), which may include adjustment to different provider networks, plan benefit packages, and supplementary benefits. However, recent reports suggest that many insurers will stop offering plans in 2026.3,4 This study characterized the scale and impact of Medicare Advantage plan exits for beneficiaries.”
  • STAT News reports,
    • “After years of grand ambitions, the federal government disclosed that it is months away from rolling out a centralized list of doctors and hospitals filled with up-to-date contact and insurance information.
    • “Details of how the national provider directory will work are scant — federal officials buried the development in a document intended for health insurance companies. The directory will be in a testing phase to start. * * *
    • “The agency plans to conduct an initial beta launch of the National Provider Directory later this year, with iterative improvements and expansions to follow,” federal officials said in the guidance document for Medicare Advantage plans.”

From the Food and Drug Administrationm

  • BioPharma Dive reports,
    • “Going forward, the Food and Drug Administration will generally only require one pivotal trial to support the approval of new medicines, top agency officials announced Wednesday.
    • “Writing in the New England Journal of Medicine, FDA Commissioner Marty Makary and top deputy Vinay Prasad said they are ending the “two-trial dogma,” a standard set in the 1960s to ensure the safety and efficacy of medical products. Technological advancements mean the FDA and sponsors can now focus on designing one high-quality trial that can better assess results, they said.
    • “In practice, many drugs in recent years have sped to market with only one pivotal study, thanks to changes Congress made in 1997. But Makary and Prasad argued that a new official standard is needed. “Default options anchor individuals and institutions psychologically, and we believe that formally articulating the FDA’s new position will spur biomedical innovation,” they wrote.”
  • CNBC adds,
    • “Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring – doubling down on a push that some in the pharmaceutical industry have questioned. 
    • “In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted that the agency is going through “the proper regulatory processes” to update OTC monographs –  the rulebooks that determine which drugs can be sold without a prescription. 
    • “Makary said the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain. 
    • “In my opinion, everything should be over the counter and not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” Makary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.” 
  • Per MedTech Dive,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “The Food and Drug Administration posted an early alert Tuesday for a problem with certain Trividia Health blood glucose monitors linked to 114 injuries and one death.
    • “Earlier this month, Trividia issued a correction for four versions of its True Metrix blood glucose system. The company updated the devices’ instructions for use to clarify that patients should seek medical attention if they have symptoms of high glucose and receive an error code.
    • “The affected products may issue an error code in the case of a very high blood glucose result (higher than 600 mg/dL) or in the event of a test strip error, according to the FDA alert.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced,
    • “Data from the National Vital Statistics System
      • “After increasing from 2016 (77.1%) to 2021 (78.3%), prenatal care beginning in the first trimester decreased to 75.5% in 2024.
      • “From 2021 to 2024, care beginning in the second trimester increased from 15.4% to 17.3%, and late or no care increased from 6.3% to 7.3%.
      • “From 2021 to 2024, prenatal care beginning in the first trimester decreased, while care beginning in the second trimester and late or no care increased, for all maternal age groups.
      • “First trimester prenatal care decreased, while second trimester prenatal care and late or no care increased, for nearly all race and Hispanic-origin groups from 2021 to 2024.
      • “From 2021 to 2024, late or no care increased in 36 states and the District of Columbia.”
  • Cardiovascular Business adds,
    • Hypertensive disorders during pregnancy are being recognized more and more as early warning signs of what is yet to come.
    • “We’ve increasingly come to appreciate that pregnancy can really be seen as a red flag or a risk signal of long-term maternal cardiovascular risk when certain complications emerge,” said Michael Honigberg, MD, MPP, a preventive cardiologist and researcher at Massachusetts General Hospital.
    • These complications include preeclampsia and gestational hypertension. He said clinicians have known for more than 25 years that these hypertensive pregnancy disorders are associated with higher, long-term cardiovascular risks. However, widespread integration of this knowledge into daily practice has lagged behind. In fact, only recently have these ideas been embraced by the broader cardiovascular community.
    • “I think the lack of that next step in terms of what do as a cardiologist with that information has sort of hindered people,” Honigberg explained.
    • He emphasized that asking a woman about about pregnancy history takes one second and can yield critical insight into a patient’s future risk.
  • and
    • “After years of implanting left atrial appendage occlusion (LAAO) devices in atrial fibrillation (AFib) patients, an interventional cardiologist with the University of Chicago Medical Center (UChicago Medicine) has developed a new device that could be a more affordable alternative to Boston Scientific’s Watchman and Abbott’s Amplatzer Amulet LAA Occluder. 
    • “Atman P. Shah, MD, a professor of medicine and co-director of the cardiac cath lab at UChicago, found that the currently available devices for LAAO were still associated with significant limitations. Their round shape is a poor fit for many patients, for example, and they require active fixation. With these issues in mind, Shah developed a minimally-invasive device that seals the LAA using a gel that adapts to the AFib patient’s anatomy and then hardens. A catheter delivers the gel, and an umbrella-like piece at the end of that catheter protects the heart during treatment. 
    • “Shah believes this device will reduce the risk of stroke in these patients while also limiting the likelihood of adverse complications while it is being implanted by an interventional cardiologist.” 
  • The Washington Post reports,
    • “Scientists showed in a new study published Thursday that they could use blood draws to build a “clock” for Alzheimer’s disease that could roughly predict when symptoms will develop, findings that could eventually transform how the illness is diagnosed and treated.
    • “A simple blood test can help diagnose Alzheimer’s, but the study in the journal Nature Medicine shows how these kinds of tests could one day play a greater role in preventing the insidious, memory-robbing illness.In the new study, researchers built a model that could use blood test results to forecast symptom onset within a margin of three to four years.
    • “The technique is not yet precise enough to predict the course of a patient’s trajectory. But it could be used to identify which patients would benefit if companies are able to develop drugs to treat the disease before symptoms develop.
    • “In the short term, the approach could accelerate the research to identify such treatments by recruiting the ideal study participants: people withno symptoms, but who are at high risk for developing them soon.” * * *
    • “Suzanne E. Schindler, a dementia specialist at Washington University School of Medicine in St. Louis who helped lead the study, said she’s been involved with research studies that are attempting to test treatments before people have cognitive impairment. When those people receive a positive test, she said, they immediately ask: “So how long do I have before I develop symptoms?”
  • Medscape relates,
    • “Current research supports the idea that remission of type 2 diabetes is increasingly achievable.
    • “A 2023 study published in Diabetes Care showed that an intensive low-energy total diet replacement program in Australian primary care led to diabetes remission at 1 year in about half of the participants with recently diagnosed type 2 diabetes, with higher remission rates tracking with greater weight loss. Meanwhile, a September 2025 systematic review and meta-analysis in the same journal pooled 18 nonsurgical randomized controlled trials and found that structured interventions, particularly those producing substantial weight loss, consistently achieved clinically meaningful remission rates.
    • “Evidence from other journals points in the same direction.”
  • and
    • “The therapeutic variations among patients with chronic obstructive pulmonary disease (COPD) present ongoing treatment challenges. However, the two currently approved biologics, dupilumab and mepolizumab, have shown success for a subset of patients with type 2 inflammation, and more biologics are in the pipeline for COPD, said Don D. Sin, MD, a pulmonologist at the University of British Columbia, Vancouver, Canada, in a presentation at the 2025 GOLD International COPD Conference.
    • “Both dupilumab and mepolizumab were originally approved for asthma but were subsequently studied in patients with COPD who continue to experience symptoms and moderate-to-severe exacerbations despite other treatments and who demonstrate type 2 inflammation based on high blood eosinophil counts, Sin said. The biologics target inflammatory pathways to get to the root of the problem, he added.”
  • Per Health Day,
    • “Cumulative lead exposure is suggested as a potential dementia risk factor, according to a study published online Feb. 12 in Alzheimer’s & Dementia.
    • “Xin Wang, Ph.D., M.P.H., from the University of Michigan in Ann Arbor, and colleagues examined prospective associations between lead exposure and incident Alzheimer disease (AD) and all-cause dementia. Blood lead was measured at baseline and patella and tibia lead were estimated for 6,217 and 5,865 participants, respectively, from the National Health and Nutrition Examination Survey (NHANES)-III (1988 to 1994) and 8,038 and 4,824 participants, respectively, from continuous NHANES (1999 to 2016), and was then linked to Medicare and the National Death Index for incident AD and all-cause dementia.
    • “In continuous NHANES, the researchers found that when comparing quartile 4 with quartile 1, estimated patella lead was associated with AD and all-cause dementia (hazard ratios, 2.96 and 2.15, respectively). Weaker associations were observed in NHANES-III. No association was seen for blood lead.”
  • and
    • “Pain during pregnancy and after delivery can significantly increase a woman’s risk of postpartum depression, a new evidence review has concluded.
    • “Further, there are specific pain-related risk factors that influence the odds of postpartum depression among women in racial and ethnic minorities, researchers reported in the journal Current Psychiatry Reports.
    • “There are multiple interrelated factors that contribute to pain, particularly childbirth-related pain,” researcher Sudhamshi Beeram, a graduate student at the University of Illinois Urbana-Campaign, said in a news release.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “There’s “a hunger for a different kind of dialogue” when it comes to relations between payers and providers, according to Aetna President Steve Nelson.
    • “Mr. Nelson laid out a vision for Aetna that centers on rebuilding trust in the industry, an effort he said is already producing measurable results with some of the country’s largest health systems and that informed Aetna’s recognition as Press Ganey’s inaugural health plan of the year earlier this month.
    • “I can tell you firsthand that the provider community and provider organizations wake up every day trying to do good work. And so do payers,” Mr. Nelson told Becker’s. “I think if we can start with positive intent and change the dialogue — if we can focus on the patient and the member as opposed to our own issues — we end up in a better place.”
    • Mr. Nelson, who took the helm at Aetna in late 2024 after leading UnitedHealthcare and value-based primary care company ChenMed, said the insurer’s strategy rests on three themes: better navigation to help members move through a complex system, an advocacy mindset that treats member interactions as more than transactions, and stronger partnerships with providers.
    • “That last theme, he said, is one the industry needs to focus on getting right. The payer-provider dynamic “has not always been super constructive,” Mr. Nelson said, “and that needs to change. This idea that we can’t work together is not true.”
  • Fierce Healthcare relates,
    • “Despite a string of recent selloffs, executives told analysts Thursday that hospital deals are still likely on the table for Community Health Systems in 2026. 
    • “The Franklin, Tennessee-based for-profit, currently owns or leases 65 affiliated hospitals. It’s cut down its portfolio by about 35% since 2019, with a string of divestitures announced or executed in the past handful of months alone. 
    • “The dealmaking has helped the company turn its first cashflow-positive year in some time, and is fueling both increased investment into CHS’ remaining core hospitals as well as efforts to deleverage. 
    • ‘As of the end-of-year earnings call, Kevin Hammons, CHS director and CEO, told curious analysts that the company is “getting closer to the end of our programmatic divestitures,” but that it was still in the “early stages of discussions” for “a couple transactions” that aren’t guaranteed reach the finish line. CHS is still getting inbound interest on some of its other hospitals in strong markets, he said, but the company is less eager to let those facilities go.”
  • and
    • “In a fourth-quarter conference call, Insmed CEO Will Lewis admitted that it was “audacious” that his company would project sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026. Then he laid out the case of why the forecast isn’t so cheeky at all. 
    • “We have a number of different data sources we examine,” Lewis said on Thursday morning. “Across all the metrics, we’re seeing [numbers] at or above our targets and that’s very much behind why we have a conviction that we’ll do at least $1 billion in revenue in Brinsupri this year.”
    • “Approved in August with much fanfare as a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, Brinsupri was pegged by analysts at Mizuho Securities for a peak sales potential of $6.6 billion, but even they were surprised by its dynamic launch. Last month at the J.P. Morgan Healthcare Conference, Insmed revealed sales of $145 million in the fourth quarter, promptingMizuho to call it “a ginormous result.” 
    • “On Thursday, Lewis added that the launch “surpassed even our most ambitious expectations,” which were based on “a basket of historically strong respiratory launches as our guide.”
  • Healthcare Dive tells us,
    • “Telehealth use in primary care has held fairly stable in recent years, suggesting the sector has reached an equilibrium after a boom in virtual care amid the COVID-19 pandemic, according to an analysis by Epic Research. 
    • “Telehealth visits accounted for over 8% of primary care encounters in July 2022, according to the research published on Tuesday. By October 2025, telehealth made up just under 6% of visits — a roughly 30% decline. 
    • “But since 2023, the share of virtual care visits in primary care has held relatively steady at around 6% to 7% of appointments.”
  • Per Beckers Hospital Review,
    • “With cancer care growing beyond hospital walls and more cancer patients surviving than ever before, health systems in the U.S. are doubling down on their oncology infrastructure commitments.
    • “Cancer care can no longer be designed around treatment alone. We must intentionally redesignoncology as a continuum of care, where survivorship is not an afterthought but a core clinical strategy,” Robert Stone, CEO at Duarte, Calif.-based City of Hope, told Becker’s.
    • “As breakthroughs in precision diagnostics and cellular therapies accelerate at a rapid pace, leaders are tasked with balancing lifesaving but expensive cancer care investments with other system priorities.
    • “Hospital and health system leaders often underestimate the complexity of patient selection, treatment timing and site-of-care decisions,” Armin Ghobadi, MD, bone marrow transplant specialist and medical oncologist at St. Louis-based Siteman Cancer Center, told Becker’s. “Ultimately, successful immunotherapy programs depend on tight alignment between clinical expertise, operational authority and sustainable financial models — recognizing immunotherapy as an enduring service line rather than a one-time therapeutic event.”
  • and
    • “Select Medical, which operates more than 100 critical illness recovery hospitals in the U.S., plans to close its hospital in Meridian, Miss., by March 13. 
    • “In an online statement, Regency Hospital-Meridian said it is no longer accepting new admissions and will close on or before March 13.
    • “Regency Hospital-Meridian is a 40-bed facility on the second floor of Baptist Anderson Regional Medical Center-South, according to a Feb. 19 report from The Meridian Star. A Select Medical spokesperson told the Star the planned closure is an operational business decision and patients can receive care at Ochsner Specialty Hospital, also in Meridian.”

Midweek report

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • The New York Times reports,
    • “The director of the National Institutes of Health, Dr. Jay Bhattacharya, will take on the additional role of acting director of the Centers for Disease Control and Prevention, two administration officials said on Wednesday.
    • “Dr. Bhattacharya will continue to run the N.I.H., according to the officials, who insisted on anonymity to speak about personnel decisions before President Trump announces them. He will serve until Mr. Trump appoints a permanent director — a position that now requires confirmation by the Senate.
    • “The C.D.C. has run through a series of leaders since Mr. Trump returned to the White House last year.
    • “A physician and medical economist who left Stanford University to join the Trump administration, Dr. Bhattacharya has no formal training in public health. But his research has focused on the well-being of populations, which is the core mission of public health, and thus the C.D.C.”
  • Bloomberg Law relates,
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz said Tuesday that potential legislation to codify the Trump administration’s plan to link US drug prices to lower prices in other countries would need to take into account the needs of the pharmaceutical industry. 
    • “I think we’ve established a deep passion to preserve innovation,” Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration’s most-favored-nation proposal. “If it’s not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry.”
    • “Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to “codify MFN in a way that industry finds is reflective of what was signed in the contracts.”
  • The American Hospital Association tells us,
    • “The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory requirements under 42 CFR Part 2, which protect the confidentiality of substance use disorder patient records. As of Feb. 16, the program uses a range of civil enforcement mechanisms, including civil money penalties, to ensure compliance with new provisions from section 3221 of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. This section aligns federal privacy standards for SUD records more closely with those under HIPAA and strengthens confidentiality protections. In compliance with the provisions, HHS OCR has begun accepting complaints of alleged confidentiality violations and SUD record breach notifications.”
  • Adam Fein, writing in his Drug Channels blog, let us know,
    • “The Centers for Medicare & Medicaid Services (CMS) has just released its initial 2026 data on enrollment in Medicare Part D prescription drug plans (PDPs).
    • “DCI’s exclusive analysis shows that 83% of seniors remain enrolled in PDPs with preferred pharmacy networks—essentially unchanged from 82% in 2025, but sharply lower than the 99% peak in 2023. Meanwhile, the number of major Part D plans offering preferred networks has fallen to a record-low eight.
    • “The new enrollment data reveal a clear shift in competitive positioning: Albertsons and Publix are now preferred in every major plan. Walgreens is holding strong. Walmart—the company that invented the Part D preferred network model—has slipped to the middle of the preferred pack.
    • “Meanwhile, smaller pharmacies have fully abandoned PDPs’ preferred networks in 2026. 
    • “At the same time, the IRA’s expansion of the Low-Income Subsidy (LIS) means a growing share of beneficiaries have little financial incentive to use a preferred pharmacy at all. Add in the PBM reforms in the Consolidated Appropriations Act of 2026, and the preferred network model will gradually lose relevance.” 

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 6.08%increase; green up pointing triangle application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional testing in the elderly.
    • “The move means that Moderna’s experimental flu shot is largely back on track after the FDA’s surprise decision earlier this month to refuse to start a review of its application. The decision came after discussions with White House and health department officials, people familiar with the matter said. Moderna said it also met with the FDA and proposed a revised approach. 
    • “Now, the FDA will review the application and is expected to make a decision by August, though approval isn’t guaranteed. If approved, Moderna’s flu shot, mRNA-1010, could become available for the 2026-27 flu season.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has accepted Bristol Myers Squibb’s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson’s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment.” 
  • MedTech Dive informs us,
    • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
    • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
    • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
  • and
    • “Medtronic said Tuesday that a surgeon completed the first U.S. procedure for its Hugo robotic surgery system, shortly after the company received Food and Drug Administration clearance for the platform.
    • “The first surgery was a prostatectomy procedure performed at the Cleveland Clinic. Along with the Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install Hugo, with Atrium Health being the first hospital in the U.S. to do so that was not part of the investigational device exemption clinical study.”
  • Beckers Hospital Review notes,
    • “The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
    • “Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
    • “The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release.”

From the judicial front,

  • Bloomberg Law reports,
    • “A prominent US physicians group is suing the Trump administration, alleging it violated its free-speech rights over its public support of gender-affirming care for minors.
    • “The American Academy of Pediatrics said it was hit in January with a Federal Trade Commission civil investigative demand for a “sweeping array of information” that includes comments the group has made about gender dysphoria treatment and communications with other groups regarding the development of clinical guidance on gender-affirming care.
    • “Filed Tuesday in the US District Court for the District of Columbia, the complaint is the latest turn in an ongoing battle between the AAP and the Trump administration.
    • “The parties are fighting in another federal court over Trump administration vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.”

From the public health and medical / Rx research front,

  • Progeny Health released its “2026 Progeny Health Trends Report — your essential guide to the evolving landscape of maternal and infant health in America.” Check it out.
  • Cardiovascular Business reports,
    • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
    • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
    • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
    • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.” 
  • Per a National Institutes of Health news release,
    • “A study in mice found that after a bone fracture, the nerves that sense pain also promote healing by signaling for bone repair and wound healing.
    • “The findings could lead to new treatments that stimulate bone repair and might be used to drive bone formation in bone disorders such as osteoporosis.”  
  • Per Healio,
    • “Less than 2 extra hours of walking per week could help mitigate the increased mortality risk among women with breast cancer who also have a higher genetic predisposition to obesity.
    • “An analysis of more than 4,000 women with breast cancer found those who have the highest value of genetic score genes linked to obesity had a 15% greater risk for death than those with the lowest value.
    • “However, if women in that highest tertile of the genetic score walked approximately 15 additional minutes per day, their mortality risk would be similar to those with lower scores.”
  • Per Health Day,
    • “A new advance might help doctors improve movement in people with Parkinson’s disease by tracking their gait-related brain waves in real time.
    • “An experimental brain implant can capture the signals of movement-related brain regions while Parkinson’s patients perform daily activities like walking to the kitchen or strolling through a park, researchers reported Feb. 13 in the journal Science Advances.
    • “What’s more, researchers have figured out how to read those brain recordings, allowing a deeper understanding of the gait problems associated with Parkinson’s, researchers said.”
  • Per Fierce Pharma,
    • “With their blockbuster obesity drugs, Eli Lilly and Novo Nordisk have uncovered a variety of ailments the incretin treatments can combat.
    • “Chalk up another new potential expansion for Lilly as it has found in a phase 3b trial that combining Zepbound and its autoimmune treatment Taltz can provide added benefits for psoriasis patients who are obese or overweight.” 
  • and
    • “Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. 
    • “In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. 
    • “Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release.” 

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

  • Beckers Payer Issues points out
    • “Paul Markovich, president and CEO of Ascendiun, the parent company of Blue Shield of California, is not one to sugarcoat the state of the healthcare system.
    • “I don’t see how you can look at it and say there isn’t a fundamental problem. It’s systemic in nature,” Mr. Markovich said on the Becker’s Healthcare podcast.
    • “Mr. Markovich was one of five health insurance CEOs who testified before House lawmakers in January over the broad topic of rising healthcare costs. The hearings lasted more than nine hours and covered industry consolidation, prior authorization and executive compensation. Most people would be nervous to be summoned before Congress in general, much less to speak to lawmakers about controversial topics — but not Mr. Markovich.” * * *
    • “His message to the industry is blunt: Stop asking for more money.
    • “This is our new normal. We have to, as many other industries have, figure out how to make an impact and do better with fewer resources and be more productive. That has not been the mindset of the industry for most of my career,” he said.
    • “We have to get into a different mindset: How do we make healthcare affordable? We all have to be financially viable, but how do we make healthcare affordable and worthy of our family and friends? That means we have a cost problem that we need to address,” he added. “I’m hopeful that creating that kind of budgetary, top-down pressure helps create that mindset and gets us into a much more innovative phase in healthcare, one where we really are focused on how to make things better for the patient and more efficiently.”
    • “To listen to the full conversation with Mr. Markovich about PBM reform, the company’s efforts to unbundle pharmacy benefits and keep Blue Cross Blue Shield plans competitive, plus his scathing rebuke of fax machines, you can tune in here.“
  • Modern Healthcare reports,
    • “More than 20 health systems have teamed up in a bid to use technology to improve access to care in rural and underserved areas. 
    • “The National Specialty Care Access Coalition, which launched Wednesday, will prioritize standardizing care models, reforming policy and deploying pilots to speed innovation, a news release said.
    • The model enables shared learning and a unified perspective, among other advantages, according to its website.
  • MedCity News tells us,
    • “Daffodil Health, an AI platform for health plan administration and claims processing, has raised $16.3 million in Series A funding to help scale the company, it announced on Tuesday.
    • “The San Francisco-based startup provides AI-based software for U.S. health plans and third-party administrators to manage claims pricing and payment integrity. Its platform allows payers to handle out-of-network repricing in-house, using transparent benchmarks and real-time reporting. This work has historically been outsourced to vendors that have built “multi-billion dollar businesses sitting between providers and payers,” according to Navin Nagiah, CEO and co-founder of Daffodil Health. It offers a SaaS pricing model, versus a percentage-of-savings pricing model that companies like MultiPlan and Zelis use.
    • “We have automated that entire workflow end-to-end,” he said. “When a claim comes in, we benchmark it against market data, Medicare rates, historical allowed amounts by MSA, percentile distributions, and even provider-specific acceptance history. It takes minutes to configure, and then the system runs automatically claim by claim. Our goal is to give plans control, automation, and transparency at a fraction of the historical cost.”
  • Fierce Healthcare adds,
    • “Optum is rolling out a new AI tool that aims to address some of the key barriers to value-based care, from data fragmentation to administrative burden.
    • “The company said in an announcement on Wednesday that the Value Connect platform supports both payers and providers in value-based care work, leaning on artificial intelligence to surface ways to improve and identify areas where programs are underperforming. The tool can also identify and quickly facilitate interventions that improve outcomes, either directly or embedded within other platforms, Optum said. 
    • “The goal of Value Connect, per the company, is to make it easier for payers and providers to collaborate as well as improve the performance of value-based care programs.
    • “We’re accelerating the shift to value-based care by meeting payers and providers where they are in their journey,” said Beth Merle, senior vice president of provider enablement at Optum Insight, in the announcement. “The solution empowers organizations to proactively manage risk and costs while improving outcomes for the people they serve.”
  • Health Data Management informs us,
    • “Clinician turnover and burnout have been two of the core issues threatening healthcare, with staffing trends already having been exacerbated by the COVID-19 pandemic. 
    • “However, there are growing indications that some of the churn caused by revolving-door policies to staffing are abating. But a recent report suggests that some of the negative effects of staffing upheaval remain, including restrictions on access, rising cost pressures and inconsistent outcomes. 
    • “Still, the suggestion that staff churn is abating suggests that healthcare organizations are improving efforts to find appropriate clinicians and staff, and then keeping them happier and willing to stay where they are.” 
  • Per MedCity News,
    • “Eli Lilly has been scouting for drugs to follow the trail blazed by its blockbuster cardiometabolic medicines. Its latest pipeline-building deal has the pharmaceutical company paying $100 million for rights to a clinical-stage CSL Limited drug addressing an increasingly competitive target associated with chronic inflammation.
    • “Under deal terms announced late Tuesday, CSL retains rights to the drug, clazakizumab, for prevention of cardiovascular events in patients with end-stage kidney disease while Lilly gains rights in other indications. Lilly has not disclosed its plans for the antibody but cardiovascular disease has become a particular area of interest for the company and it’s also the focus of clinical-stage programs in clazakizumab’s drug class.
    • “Clazakizumab is a monoclonal antibody designed to bind to and block IL-6, a signaling protein that in excessive amounts plays a role in inflammation. While FDA-approved antibody drugs that block this target have already reached the market in certain inflammatory disorders, there’s renewed industry interest in expanding this approach to more diseases, particularly the inflammation that drives cardiovascular conditions.”
  • Per Fierce Pharma,
    • “With $55 billion earmarked to bolster its U.S. operations, Johnson & Johnson is the latest drugmaker to zero in on expansion plans that are aimed, at least in part, at abating the Trump administration’s pharmaceutical tariff threats. 
    • “J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. 
    • “J&J did not lay out a timeline for the plant’s expected completion, nor did the company specify the types of “cutting-edge cell therapy technologies” it plans to employ at the new site. 
    • “Still, Wednesday’s announcement adds more color to J&J’s overall $55 billion U.S. investment plan, unveiled last March, which came with a pledge to construct three new domestic manufacturing sites and expand others in the company’s existing drug and medtech network.” 

Tuesday Report

David Ermer–Congress, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, HSA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports.
    • “The Congressional Budget Office last week put out an “are you sitting down?” report that projected the U.S. government will spend $1 trillion on interest payments for its debt this year. One. Trillion. Dollars. To finance its gigantic and growing debt. And it will only get worse from there.
    • “It also projected that the U.S. government will spend $1.853 trillion more than it brings in through revenue this year (that’s the budget deficit) and have an even wider gap in 2027. Talks of slashing spending and making difficult choices last year have given way to election-year spending-increase promises in 2026. Perhaps complicating matters more, DOGE never really caught on in 2025, and Republicans seem reluctant to repeat that experiment any time soon.
    • “Budget angst tends to come in waves, but the debt never stops growing. I wrote about the $13.7 trillion debt here in 2010. That was $25 trillion ago.”
  • and
    • “The [Homeland Security Department] shutdown enters Day 4, with little chance of an end in sight after Congress failed to reach a deal on immigration-enforcement policies.”
  • Federal News Network reminds us about the bipartisan federal employment bills brewing in Congress.
  • Last Friday, the HHS Office for Civil Rights posted model HIPAA notices of privacy practices that were update for the Part 2 changes.
  • Navia Benefits lets us know,
    • “Health Savings Accounts (HSAs) have traditionally been viewed as a tax-advantaged way to pay for out-of-pocket medical expenses. But today’s data tells a much bigger story: they can function as a powerful financial wellness tool.
    • “HSAs are increasingly operating like powerful long-term investment vehicles rather than just spending accounts. Yet misconceptions persist across the workforce, and employee education continues to lag. With rising healthcare costs and growing financial pressures, it is a good time to elevate the HSA conversation.
    • [Navia’s article] examines the triple tax advantages, workforce perception trends, and evidence-based insights to guide employers in maximizing HSA participation and value.

From the Food and Drug Administration front,

  • Per a Senate news release,
    • :U.S. Senator Bill Cassidy, M.D. (R-LA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a landmark report detailing legislative and regulatory reforms to modernize the Food and Drug Administration (FDA). These proposals aim to maintain American biomedical dominance and ensure patients have timely access to the latest lifesaving treatments. The HELP Committee’s recommendations are directly in line with President Trump’s mission to improve the health of American children and families.
  • Fierce Pharma tells us,
    • “Harmony Biosciences is rounding out the U.S. patient pool eligible for its sleep disorder pill Wakix after notching a pediatric nod from the FDA that positions the drug as a treatment for cataplexy in people ages 6 and older with narcolepsy.
    • “The new addition to Wakix’s label makes it the only non-scheduled treatment for both adult and pediatric narcolepsy patients in the U.S. with or without cataplexy. That non-scheduled classification represents an “important distinction that supports its clinical utility,” Harmony’s CEO, Jeffrey Dayno, M.D., commented in a press release. Cataplexy is a common symptom of narcolepsy that involves a sudden weakening of muscles, often when triggered by a strong emotion.”
  • and
    • “Two months after Johnson & Johnson’s Rybrevant Faspro picked up its first FDA approval, the subcutaneous lung cancer drug has scored a label expansion to be given monthly.
    • “On Tuesday, J&J touted a “simplified” monthly dosing regimen for the drug’s combination with lazertinib for the first-line treatment of epidermal growth factor receptor EGFR-mutated advanced non-small cell lung cancer. Previously, the combo was approvedas an every-two-week regimen.
    • “For weeks 1 through 4, patients must still receive weekly doses of Rybrevant Faspro. Beginning week 5, the doses can shift to monthly administration.”

From the judicial front,

  • The Wall Street Journal reports,
    • “Bayer BAYN is making a new multibillion-dollar push to resolve a years long legal nightmare over Roundup weedkiller.
    • “The German pharmaceutical and agriculture conglomerate on Tuesday said it proposed to settle a nationwide class-action lawsuit to resolve claims that its flagship herbicide causes cancer. The settlement plan includes setting aside more than $7 billion to fund payments over 21 years. 
    • “Law firms representing tens of thousands of plaintiffs filed a motion Tuesday seeking approval of the settlement. The proposal requires court approval in Missouri, where the bulk of Roundup cases are outstanding.” 

From the public health and medical / Rx research front,

  • Patient Care reports,
    • “New data from the 2026 Primary Care Scorecard highlight measurable associations between regular primary care access and improved outcomes for patients with chronic disease.
    • “In the interview, Morgan McDonald, MD, National Director for Population Health at the Milbank Memorial Fund and practicing primary care internist and pediatrician, outlined key findings relevant to frontline clinicians.
    • “Among adults with chronic disease, having a usual source of care was associated with:
      • 20% lower hospitalization rates
      • 54% lower total cost of care
    • “For children with chronic disease, reductions in emergency department visits and hospitalizations for ambulatory care–sensitive conditions—such as pneumonia and otitis media—were “cut roughly in half.”
    • “The report also reinforces primary care’s role in prevention. Nearly all adults with a usual source of care received preventive services for conditions such as cardiovascular disease and common cancers, compared with approximately two-thirds of adults without a regular source of care. Similar trends were observed in pediatric populations, including higher receipt of counseling related to nutrition, exercise, injury prevention, and obesity prevention.”
  • Infectious Disease Advisor tells us,
    • “Low rates of diagnostic testing for respiratory syncytial virus in adult outpatient settings may result in an underestimated disease burden, potentially impeding the effective use of novel vaccines and therapeutic interventions.” 
  • MedPage Today informs us,
    • “Health systems where most pregnant patients have a high or moderate risk for preeclampsia may benefit from universal dispensation of aspirin, results from a large cohort study suggested.
    • “The rate of preeclampsia with severe features at a Texas health system was a relative 29% lower after it implemented universal aspirin dispensation in prenatal care compared with the period when aspirin was not recommended, regardless of risk factors (5.2% vs 7.1%; OR 0.71, 0.66-0.78, P<0.001), Elaine Duryea, MD, of University of Texas Southwestern Medical Center in Dallas, reported here.”
  • Medscape points out the top ten triggers for pancreatic cancer which is “an often silent disease.”
  • STAT News reports,
    • “Compass Pathways on Tuesday disclosed results from two Phase 3 studies that support a potential approval of its psilocybin treatment for severe depression, but more detailed data are needed to determine how beneficial the drug would be for patients.
    • “In both trials, patients who received the company’s psychedelic medicine saw greater improvements on a measure of depression than the control group, Compass said in a press release. Its drug, called COMP360, could be the first psilocybin product on the market and the second psychedelic approved after Johnson & Johnson’s Spravato, a ketamine derivative.
    • “Taken together, the data “probably meets the bar for approval. It doesn’t shout out to you that this is miraculous,” said Jerry Rosenbaum, director of Massachusetts General Hospital’s Center for Neuroscience of Psychedelics, who was not involved with the study.”
  • and
    • Ocular Therapeutix said Tuesday that its experimental treatment, called Axpaxli, maintained vision with less frequent injections compared to a standard treatment for patients with a common cause of age-related blindness — achieving the primary goal of a late-stage clinical trial. 
    • “However, the difference in the durability of treatment between Axpaxli and the active control in the study was narrower than investors expected — a finding that may spark debate about Axpaxli’s commercial potential in wet age-related macular degeneration, where effective drugs are already approved.”
  • Fierce Pharma adds,
    • “Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted in a lupus nephritis nod last fall—Roche is touting new data that could tee up the antibody for a world-first approval.
    • “In an early look at results from the late-stage Majesty study in adults with primary membranous nephropathy, Gazyva (obinutuzumab) helped significantly more patients achieve complete remission at the two-year mark compared with the immunosuppressant tacrolimus, Roche said in a Feb. 16 press release. 
    • “Gazyva’s performance enabled the trial to hit its primary endpoint, and key secondary endpoints further pointed to statistically significant and clinically meaningful outcomes on overall remission at Week 104 and complete remission at Week 76 of the study, the company said.” 
  • Genetic Engineering and BioTechnology News relates,
    • “Researchers headed by a team at the University of California, Irvine, Joe C. Wen School of Population & Public Health have built what they suggest is the first cell type-specific gene regulatory network (GRN) map for Alzheimer’s disease (AD), which shows how genes causally regulate one another across different types of brain cells affected by AD.
    • “The researchers developed a machine learning framework, SIGNET (Statistical Inference on Gene Regulatory Networks), which reveals cause-and-effect relationships rather than simple genetic correlations, and applied this to uncover key biological pathways that may drive memory loss and brain degeneration. Their results pointed to numerous influential “hub genes” that offer promising potential new targets for early detection and therapeutic intervention. The investigators say their methodology is also applicable to other complex diseases, including cancer.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ongoing headwinds caused by elevated utilization and medical costs continued to drag major health plans in the fourth quarter, completing the story of a complex 2025 for the industry.
    • “The most profitable company for the full-year was UnitedHealth Group, with $12.05 billion in earnings for 2025. The healthcare giant had a sizable lead on the next-highest payer in terms of profitability, which was Cigna at just below $6 billion.
    • “However, the company posted just $10 million in profit for Q4, the lowest tally among payers that turned a profit in the quarter. In Q4, the company saw a medical loss ratio of 92.4%, which settled to 89.1% for the full year.”
  • Fierce Healthcare adds,
    • “CommonSpirit Health’s adjusted operating margin inched into the black during the three months ended Dec. 31 as the organization’s leadership touted “noticeable” quarter-to-quarter performance gains stemming from strong volumes and efficiency. 
    • “The 138-hospital Catholic nonprofit posted a $78 million operating loss (-0.8% operating margin) for the second quarter of its 2026 fiscal year; however, after normalizing for delayed income received through California’s provider fee program, the system reached a narrow operating income of $2 million (0.0% operating margin). 
    • “CommonSpirit also reported $456 million excess revenues over expenses after normalizing. A year prior and after adjustment, the organization had an operating income of $135 million (1.3% operating margin) and a $356 million bottom line, which it noted was bolstered by around $352 million of Federal Emergency Management Agency grant revenue.”
  • Per Beckers Hospital Review,
    • “Ontario, Calif.-based Prime Healthcare’s nonprofit public charity, Prime Healthcare Foundation, acquired Lewiston-based Central Maine Healthcare on Feb. 16.
    • “The foundation received Maine’s approval to acquire Central Maine Healthcare in late November after sharing plans to acquire it in January 2025. 
    • “The transaction comprises Lewiston-based Central Maine Medical Center, Bridgton (Maine) Hospital, Rumford Hospital, Rumford (Maine) Community Home, Auburn, Maine-based Bolster Heights Residential Care, Lewiston-based Maine College of Health Professions, Lewiston-based CMH Cancer Care Center, and more than 40 physician practices, according to a Feb. 16 news release.
    • “The Prime Healthcare Foundation comprises 21 hospitals across the U.S. following the acquisition, with more than $4 billion provided in charity care.” 
  • and
    • “Marshfield Medical Center-Wisconsin Rapids Campus will open to patients March 1.
    • “The campus includes the soon-to-open hospital and Marshfield Clinic Wisconsin Rapids Center, according to a Feb. 16 health system news release.
    • “The hospital will include inpatient beds, an emergency department, exam and procedure rooms, radiological services that include general x-ray, computed tomography and ultrasound, and on-site laboratory testing.”
  • and
    • “Telehealth company eMed has partnered with CVS Caremark to offer a GLP-1 benefit model that lets employers subsidize weight loss medications without covering the full cost, Axios reported Feb. 16. 
    • “The arrangement allows eligible employees to purchase GLP-1s online through eMed and receive weight management services including side effect management, weekly check-ins and blood testing. Employers can decide how much of the cost to subsidize, the report said.” 
  • Per Healthcare Dive,
    • “Amwell is projecting lower revenue in 2026 after the health technology firm divested assets, executives said during an earnings call Thursday. 
    • “The firm expects revenue from $195 million to $205 million this year. In comparison, the telehealth vendor and health tech firm brought in revenue of $249.3 million in 2025.
    • “The top line for 2026 is smaller, but it’s “primarily high-quality, high-upside, sticky revenue,” CEO Ido Schoenberg said on the call.”
  • Per MedTech Dive,
    • “Danaher said Tuesday it has agreed to acquire patient monitoring company Masimo for $9.9 billion to bolster its diagnostics franchise.
    • “Masimo will become a standalone business unit and brand within Danaher’s diagnostics portfolio, operating autonomously while strengthening Danaher’s offering in acute care settings, the companies said.
    • “Masimo’s advanced sensor technology and AI-enabled monitoring bring powerful new capabilities to our diagnostics portfolio,” Julie Sawyer Montgomery, Danaher’s executive vice president for diagnostics, said in a statement.
    • “The $180-per-share cash deal has been unanimously approved by both Masimo’s and Danaher’s boards, according to Masimo.”

Holiday Weekend Update

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

Happy Presidents’s Day!

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

From the public health and medical / Rx research front,

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

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

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

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front,

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

From the cybersecurity vulnerabilities and breaches front,

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

From the ransomware front,

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

From the cybersecurity business and defenses front,

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