FEHBlog

Monday report

David Ermer–CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Beckers Hospital Review reports,
    • “Americans spend more than $1.6 trillion a year on hospital care — roughly one-third of all health spending — and a new paper from the nonprofit think tank Paragon Health Institute argues that government policy is the primary driver of why those costs keep climbing.
    • “The paper, “The Hospital Cost Crisis: How Government Policies Drive Consolidation, Undermine Competition, and Fuel Soaring Prices,” was authored by John Graham, a visiting fellow at Paragon with nearly three decades of health policy experience.” * * *
    • Click here to read the paper in full. FEHBlog note — The article includes ten highlights from the report.
  • and
    • “Johnson & Johnson will begin marketing four prescription drugs on the Trump administration’s TrumpRx website, according to an April 24 report from CBS News.
    • “The drugs include metformin, metformin extended release, Invokana and Xarelto. Pricing on the platform shows Invokana discounted 62% to about $225 from $598.56, Xarelto discounted 68% to about $197 from $611.82, and Invokamet XR — an extended-release combination of canagliflozin and metformin — discounted 62% to about $225 from $598.56, based on listed cash-pay prices.”
  • MedPage Today relates,
    • “Advocates for the LGBTQ+ community claimed a win this week after the Trump administration pledged to reinstate the 988 Suicide and Crisis Lifeline specialized support program tailored to their needs.
    • During a Senate hearing earlier [last] week, HHS Secretary Robert F. Kennedy Jr. was asked whether he would commit to restoring the tailored line for LGBTQ+ callers to 988, as required by law, after the Trump administration removed it last summer.
    • “We are working on getting it up now,” Kennedy said.
    • “While most 988 calls are routed to the nearest call center, callers who press 3 or text PRIDE were once connected to a centralized network of trained crisis counselors who have shared lived experiences or are trained to provide services to LGBTQ+ youth.
    • “Linking callers to local resources is usually best, since support outside of a phone call might be needed. However, for those in states where attacks on LGBTQ+ individuals are widespread, local resources may not be preferred, Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, told MedPage Today.“
  • The American Hospital Association News tells us,
    • “The AHA again is asking the Health Resources and Services Administration to take action after Eli Lilly warned hospitals that they could lose access to discounted drug prices unless they comply with new data submission requirements.
    • “The AHA said Eli Lilly recently issued a letter to hospitals participating in the 340B Drug Pricing Program threatening the “imminent loss” of discounted pricing if claims data are not submitted “without further delay.”
    • “The AHA for months has raised concerns with HRSA about these practices.
    • “Unfortunately, we are not aware of any action that HRSA has taken to address these unlawful drug company claims-data policies, even as more and more companies have announced policies similar to Lilly’s,” the AHA wrote. “HRSA’s inaction here stands in stark contrast to the speed with which it acted in 2024 when the drug companies announced their unlawful rebate policies.”

From the Food and Drug Administration front,

  • Health Exec reports,
    • “Multiple wound and burn gel products are being removed from where they are used or sold, after it was discovered that a packaging failure was leading to the sterile barrier being breached. Unfortunately, this has led to at least 14 serious injuries. 
    • “The manufacturer of the gels, Integra LifeSciences, issued a letter to distributors of the products,  branded as MediHoney and CVS Wound Gel. The products are sold in retail settings, but also may be found in patient care settings. 
    • “In a statement, the U.S. Food and Drug Administration (FDA) said it’s aware of the issue and provided the known details. The agency said it has determined that using wound gels with the defective packaging may “cause temporary or reversible health problems, or—though unlikely—serious health problems.”
    • “Despite the risk of severe infection and the recorded injuries, there are no known deaths associated with the recalled wound gels.” 
  • The American Hospital Association adds,
    • “The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be taken out of use due to a design defect where the sheath introducer may not split as intended. In addition, the FDA issued an Early Alert for Omnicell i.v.STATION sterile labels. Omnicell recommends customers do not use affected labels. They should verify the accuracy of labels on filled products.”
  • Fierce Pharma tells us,
    • “AstraZeneca’s systemic lupus erythematosus (SLE) med Saphnelo may have earned a considerable convenience edge in the United States, courtesy of an FDA nod clearing the drug for self-administration via a once-weekly autoinjector. 
    • “As with the drug’s original SLE nod in 2021, the self-administration green light covers the use of Saphnelo on top of standard therapy, AZ said in an April 27 release. In its original formulation, Saphnelo, also known as anifrolumab, is given as an intravenous infusion. 
    • “The FDA signed off on the new administration route after reviewing data from the late-stage TULIP-SC study, in which subcutaneous dosing of Saphnelo triggered statistically significant and clinically meaningful disease activity reductions versus placebo, according to AZ.”
  • and
    • “Johnson & Johnson is bolstering the case for its approved schizophrenia med Caplyta to prevent relapses in the disease. 
    • “On Monday, the FDA approved J&J’s supplemental new drug application for the atypical antipsychotic to include long-term data on the med’s schizophrenia relapse-prevention capabilities.
    • “In a press release, J&J clarified that the “label update builds upon the existing clinical data and postmarketing experience across [Caplyta’s] approved uses.” 
    • “Relapses pose a significant challenge for schizophrenia patients and can disrupt stability, undermine functioning and often trigger episodes of psychosis, hallucinations and other symptoms that have the potential to disrupt daily life, according to J&J. On average, adults living with the condition experience nine relapse episodes within a six-year period, the company added.” 

From the public health and medical / Rx research front,

  • NBC News reports
    • “Deaths from rectal cancer are rising rapidly among younger adults, an alarming trend that is confounding scientists trying to understand why millennials are so hard-hit. 
    • “The rate of rectal cancer seems to be increasing more than two to three times compared to colon cancer,” said Mythili Menon Pathiyil, lead author of a new study and a gastroenterology fellow at SUNY Upstate Medical University in Syracuse, New York. 
    • “If the trend continues, rectal cancer deaths will exceed the number of colon cancer deaths — already the nation’s No. 1 cause of cancer death in people under age 50 — by 2035.”
    • “According to the American Cancer Society, 158,850 new colorectal cancers will be diagnosed in 2026. About 55,230 patients will die from the disease, with nearly a third of those deaths in people under age 65. Colon cancer and rectal cancer are similar but form in different parts of the digestive tract. 
    • “The new research, which hasn’t yet been published in a peer-reviewed journal, is scheduled to be presented at Digestive Disease Week, an annual meeting of gastroenterologists, in May. 
    • “The findings, however, strengthen an American Cancer Society study released in March showing that a rise in rectal cancer rates is driving increases in colorectal cancer diagnoses in people younger than age 65. Colorectal cancer rates have been increasing 3% each year for adults under age 50 since the late 1990s and scientists are scrambling to understand why.”
  • STAT News considers what happened to COVID?
    • “There is an ever-shrinking portion of the population that thinks it’s never been infected — the folks who call themselves Novids. Even among that population, many have all but certainly been exposed to the virus but had only asymptomatic infections.”
    • “This, many experts told STAT, explains why the threat from Covid has subsided.” * * *
    • “Most of the experts STAT consulted believe the virus either now qualifies as, or is on its way to becoming, just another one of the viruses that make people sick with cold or flu-like symptoms — with some caveats. For one, the risk remains high for some people — particularly older people, very young children, and people with medical conditions that weaken their immune systems. For another, cold and flu-like viruses trigger symptoms that range from sniffles and coughs to knock-you-off-your-feet illness. A bad case of flu can take a couple of weeks to recover from, even for a healthy person. Same with Covid.” * * *
    • “Marion Koopmans, scientific director of the Pandemic and Disaster Preparedness Center at Erasmus University in Rotterdam, the Netherlands, said at this point, annual boosting is probably not doing much for people who aren’t at high risk.
    • “What we really would need is data on what the effect is of boosting on variant specific responses AND protection from disease over increasing intervals between boosters. That data is virtually impossible to get,” she wrote in an email. (Pfizer recently announced it had halted a clinical trial the Food and Drug Administration asked it to conduct in healthy adults aged 50 to 64, because it couldn’t recruit enough volunteers.) 
    • “But for high-risk individuals, Covid boosters still offered protection against becoming sick enough to require hospitalization, the latest study in the Netherlands concluded, Koopmans said.”  
  • MedPage Today adds,
    • “Two multicenter trials [(PANORAMIC and CanTreatCOVID)] found no change in hospitalization and death rates when antiviral nirmatrelvir-ritonavir (Paxlovid) was given to COVID-19 patients already mostly vaccinated.” * * *
    • “Now, the PANORAMIC and CanTreatCOVID results reflect a COVID-19 landscape that’s shifted since the pandemic’s early period, said H. Clifford Lane, MD, former deputy director for clinical research and special projects at the National Institute of Allergy and Infectious Diseases (NIAID), and Anthony Fauci, MD, the former NIAID director.
    • “These new data indicate that the 89% relative risk reduction seen in the analysis of hospitalizations or death associated with the use of nirmatrelvir-ritonavir in the EPIC-HR trial does not apply to the current circumstances, in which most adults have varying degrees of preexisting immunity and the circulating variants are different,” Lane and Fauci wrote in an accompanying editorialopens in a new tab or window.
    • “That doesn’t mean nirmatrelvir-ritonavir’s therapeutic time has come and gone, they cautioned. PANORAMIC and CanTreatCOVID participants who took the combination drug saw enhanced recovery and faster viral load reductions, they noted, which points to both clinical efficacy and antiviral activity.”
  • Health Day tells us,
    • “The eyes are the windows not only to the soul, but also to a person’s health, a new study says.
    • Premature aging of the retina could be a red flag for major diseases like diabetes or heart disease, researchers recently reported in the journal Communications Medicine.
    • “They found that people had a higher risk of chronic disease if they had advanced aging of their retinas — the light-sensitive layer of cells that lines the back wall of the eye.”
  • Per a National Institutes of Health news release,
    • “A National Institutes of Health (NIH)-funded clinical study shows that a symptom-based treatment for babies with neonatal opioid withdrawal syndrome (NOWS) — a highly prevalent condition wherein opioid exposure during pregnancy leads to withdrawal after birth — could speed up their recovery.
    • “To treat babies with moderate to severe symptoms of NOWS, doctors often administer opioid medication, lowering the dose over time. Many doctors commonly use this scheduled dosing approach, however, the new study found that providing “as-needed” doses of opioid medications based on each baby’s signs of withdrawal helped them stop the medicine sooner and go home earlier.
    • “Scheduled opioid dosing, which includes a taper, is necessary for some infants with NOWS, however it may overtreat others,” said corresponding author Lori Devlin, D.O., a professor of pediatrics at the University of Louisville and Norton Children’s Neonatology. “The idea is that by matching treatment to disease severity, we can accelerate recovery and minimize exposure.”
  • Genetic Engineering and Biotechnology News informs us,
    • “A cellular-resolution molecular map details how Down syndrome alters human brain development before birth. The study analyzed more than 100,000 nuclei from human prenatal neocortex samples collected across 26 pre-genotyped donors during gestational weeks 13 to 23—the only window during which all the cortical neurons a person will carry for their entire life are generated. The findings suggest that Down syndrome disrupts the developmental sequence of that process, creating shifts that may help explain later differences in cognition, learning, and sensory processing.
    • “This work is published in Science in the paper, “A single-cell multiomic analysis identifies molecular and gene-regulatory mechanisms dysregulated in developing Down syndrome neocortex.“
    • “There’s a new level of detail here that had never existed before,” said Luis de la Torre-Ubieta, PhD, an assistant professor of psychiatry and biobehavioral sciences at UCLA and a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. “For the first time, we can really try to understand systematically what’s going on in the developing brain of individuals with Down syndrome.”
  • STAT News points out,
    • “The drugmaker Erasca said Monday that its RAS-targeting pill shrank tumors in 40% of patients with advanced pancreatic cancer and 62% of patients with advanced non-small cell lung cancer, results that the company said exceeded its expectations. 
    • “The new data, collected from studies done in the U.S. and China, are still preliminary. However, Erasca said the clinical benefit and tolerability of its drug, called ERAS-0015, compared favorably to daraxonrasib, a similar RAS-targeting drug from Revolution Medicines that recently showed a doubling of overall survival in patients with advanced pancreatic cancer.
    • “I’m excited about both datasets, but I think lung is more definitive at this point. The pancreatic results are maturing, but are very, very promising,” Erasca CEO Jonathan Lim told STAT. “All options are on the table.” 
  • and
    • “An oral medicine for hair loss successfully spurred hair growth in a late-stage trial, startup Veradermics announced Monday.
    • “Veradermics assessed the pill in two ways: by how many hairs grew within a square centimeter of the scalp, on average, and by how satisfied participants were with the results. Over the course of six months, men who took the drug, known as VDPHL01, either once or twice daily had between 30 and 33 more hairs per square centimeter of scalp. Men in the placebo group grew approximately seven additional hairs.
    • “Between 79% and 86% of men taking VDPHL01 said they saw improvement, along with between 72% and 84% of the clinical trial investigators — results that pleased Reid Waldman, a dermatologist turned Veradermics’ chief executive.” 
  • BioPharma Dive adds,
    • “An experimental gene editing medicine from Intellia Therapeutics has succeeded in a Phase 3 trial, positioning the company to seek approval of what would be the first treatment of its kind for a rare disorder known as hereditary angioedema.
    • “When compared to a placebo, the therapy, “lonvo-z,” reduced the rate of the disease’s hallmark swelling attacks by 87% over the course of about six months, meeting the study’s primary objective. Lonvo-z also helped rid 62% of recipients of disease attacks or the need for other therapies during that follow-up period, versus 11% of placebo patients.
    • “Intellia said, without specifics, that lonvo-z had a “favorable” safety and tolerability profile. The most common treatment-emergent side effects were infusion-related reactions, headache and fatigue, and all reported by a Feb. 10 data cutoff were mild to moderate in degree. The company has begun a “rolling” U.S. approval submission and, assuming a clearance, intends to launch lonvo-z in the first half of 2027.” 

From the U.S. healthcare and artificial inteliigence front,

  • Beckers Payer Issues reports,
    • “Elevance Health has set aside $935 million to cover potential costs tied to its ongoing risk adjustment data dispute with CMS, which threatens the insurers’ ability to enroll new members into some of its Medicare Advantage plans.
    • “CFO Mark Kaye disclosed the charge during the company’s first quarter earnings call on April 22, saying the figure reflects Elevance’s current best estimate of what the issue could cost as it works toward a resolution with the government.
    • “[Elevance CEO Gail} Boudreaux also characterized the issue as a historical payment dispute rather than a current compliance concern.”
  • and
    • “CenterWell, Humana’s pharmacy branch, is collaborating with Mark Cuban’s Cost Plus Drug Co. for an employer-based program, according to an April 27 news release.
    • “CenterWell will use Cost Plus Drugs’ SwiftyRx, a digital pharmacy software-as-a-service solution, for medication order intake. The platform should enable CenterWell to offer home delivery pharmacy services for the insurer’s eligible workforce in the Humana Associate Benefit Plan.
    • “Along with SwiftyRx, the organizations will harness Cost Plus Drugs’ drug pricing and CenterWell’s distribution strategies. The collaboration aims to ease access and reduce patient cost through smoother onboarding, automated benefit checks, lowered costs to fill prescriptions and operational efficiency.” 
  • Healthcare Dive points out,
    • Nearly three-quarters of U.S. finance leaders rank healthcare among their companies’ five biggest operating expense concerns, consulting firm Mercer found in a recent survey.
    • “The research comes as the rapid rise of GLP-1 weight-loss medications — like Wegovy and Ozempic — is adding to volatility in employer health costs.
    • “The survey results make clear the far-reaching impacts of rising health benefit costs for individual organizations,” Susan Potter, president of Mercer U.S. & Canada, said in an emailed statement. “Only about one in four CFOs said that their organization was able to absorb the cost increases over the past two years without any business impacts, such as slower wage growth, reduced hiring, or higher prices.”
  • Fierce Healthcare relates,
    • “Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report.
    • “The Pharmaceutical Strategies Group (PSG) on Monday released its annual Trends in Specialty Drug Benefits report, which offers a look at how payers are responding to rising costs for these products and striking a balance between cost management and access.
    • “PSG surveyed 228 benefits leaders representing employers, health plans and union coverage, and found that 43% ranked managing specialty drug costs as their top goal. By comparison, 37% said their No. 1 goal is to manage total cost of care, per the report.
    • “As more and more of these products come to market and existing drugs gain new indications, managing them across the pharmacy and medical benefits poses significant complexity, the report found. More payers listed this as a top challenge than access to integrated data or member affordability.”
  • The Wall Street Journal reports,
    • “Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion to bolster its blood-cancer portfolio.
    • “Ajax Therapeutics is developing AJ1-11095, a Type II JAK2 inhibitor for myelofibrosis patients.
    • “Eli Lilly’s deal to buy Ajax adds to a recent spate of pharma acquisitions, including several by Lilly.”
  • and
    • [India’s] Sun Pharmaceutical Industries will acquire U.S.-listed Organon for $11.75 billion, becoming a top three global women’s health player.
    • Organon, a Merck spinoff, has over 70 products in women’s health and general medicines, commercialized across 140 countries.
    • Sun Pharma will fund the all-cash deal through internal cash and bank financing; the acquisition will make it a top seven global biosimilars player.
  • and
    • “Ligand Pharmaceuticals LGND said it has reached a deal to acquire Xoma XOMA Royalty, a company that invests in a range of biotech firms, for around $740 million.
    • “Under the terms, Ligand will pay $39 a share in cash for Xoma, a 2.9% premium over the $37.90 closing price on Friday. The deal is expected to close in the third quarter.
    • “Both Ligand and Xoma are known as royalty aggregators for investing in drugs while they are in development and then, if they work out, collecting royalties from their sales.
    • “By absorbing Xoma, Ligand’s total portfolio would more than double in size to more than 200 drugs and experimental treatments, including a handful of medicines on the market and several in late-stage studies.”
  • MedTech Dive adds,
    • “Johnson & Johnson said Friday it has struck a deal to buy Atraverse Medical, an atrial fibrillation ablation device developer founded by the team behind Farapulse.
    • “Atraverse sells a radiofrequency guidewire used to create an atrial septal defect to treat AFib. The Food and Drug Administration cleared the Hotwire device for use in 2024.
    • “Hotwire competes with products including Boston Scientific’s ProTrack RF Anchor Wire, which Atraverse cited as the predicate product in its 510(k) submission.”
  • Beckers Health IT observes,
    • “For years, the conversation about AI in health systems centered on technology adoption: which tools to buy, which pilots to run, which workflows to automate. But as health systems move from isolated AI deployments toward enterprise-wide agentic platforms, the limiting factor is no longer the technology. It’s the people managing it.
    • “That was the central tension running through a panel of health system technology leaders at Becker’s 16th Annual Meeting in Chicago this spring. Across organizations ranging from a large rural integrated delivery network to an urban academic medical center to a national cancer system, the same challenge surfaced: operations leaders have not yet grasped that they are now managing a digital workforce — and the consequences of that gap are starting to show.
    • “The biggest barrier to us moving forward is really getting operations to understand that this fundamentally changes their role in the equation,” said Jeff Gautney, CIO of Rush University Medical Center in Chicago. “They are managing a digital workforce and they need to think that way as opposed to [thinking that] IT is monitoring this, IT is keeping an eye on it, IT is delivering this solution and I don’t really need to think any differently about it.”
  • MedCity News adds,
    • “There are plenty of AI startups on the market promising to bolster hospitals’ finances by increasing revenue. But that’s not the case for San Francisco-based Midstream Health.
    • “For most health systems, the key to unlocking dollars isn’t boosting revenue — it’s decreasing costs, said Venkat Mocherla, Midstream’s co-founder and president.
    • “Midstream, founded in 2023, uses AI to clean up and unify hospitals’ fragmented financial and operational data, which helps leaders spot savings opportunities and make smarter purchasing decisions, he explained. For instance, the platform could help surface insights that help a hospital capture missed rebates or avoid overpaying for supplies and devices.” * * *
    • T”he company’s platform is being used across health systems including Mount Sinai, CommonSpirit and Houston Methodist. Midstream primarily makes money by taking a cut of the savings it generates, which Mocherla noted aligns the startup’s incentives directly with hospitals’ financial outcomes.”

Noteworthy Death

  • Cardiovascular Business reports,
    • “Pioneer cardiologist Eugene Braunwald, MD, often referred to as the “father of modern cardiology,” died April 22. He was 96 years old.
    • “Braunwald was born in Vienna, Austria, and immigrated to the United States as a child to flee Nazi persecution. He went on to hold leadership positions with the National Heart, Lung and Blood Institute; the University of California, San Diego; Brigham and Women’s Hospital and Harvard Medical School. He authored or co-authored more than 1,000 publications over the course of his career and helped shape medical education for many years as the longtime editor of Harrison’s Principles of Internal Medicine, a premier textbook for clinicians. 
    • “Braunwald was also a lifelong contributor to a variety of industry societies, including the American College of Cardiology (ACC), American Heart Association (AHA) and European Society of Cardiology (ESC). He earned the highest honors from all of these groups over the course of his career in medicine, and the AHA even started giving out the Eugene Braunwald Academic Mentorship Award annually in 1999.”
  • RIP

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC

  • The House Ways and Means Committee will hold a hearing with health system CEOs on April 28, 2026, at 10 am ET.
  • Roll Call offers more details on this week’s activities on Capitol Hill.
  • Federal News Network interviews NARFE Staff Vice President John Hatton about OPM’s ill-advised health claims data warehouse and the Postal Service’s decision to suspend making contributions toward their employee’s retirement benefits due to its cash woes.

From the public health and medical / Rx research front,

  • Health Exec reports,
    • “The more you maintain good physical fitness from your mid-40s to your mid-60s, the likelier you are to add years to your life and life to your later years. 
    • “So conclude researchers at Texas Tech University Health Sciences Center who tracked cardiorespiratory health in around 25,000 adults from midlife through elder stages. 
    • “The team, led by Clare Meernik, PhD, MPH, assessed participants’ fitness using a treadmill test until age 65. From that point on, the researchers used Medicare data to watch for and record the onset of 11 major chronic conditions such as heart disease, diabetes, kidney disease and cancer.
    • “The Journal of the American College of Cardiology published the results April 21.”
  • The FEHBlog noted on Friday that tick bites are increasing in the U.S. The Washington Post offers relevant advice. “Experts explained what to do if you find a tick attached to your skin, including how to remove it and document it, and when to seek medical advice.”
  • Building on another FEHBlog post from Friday, the Wall Street Journal explains what heart valve patients need to know before treatment.
  • Cardiovascular Business adds,
    • “New-onset postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery, typically developing within four days of treatment. While it often resolves on its own, POAF is also associated with longer hospitalizations, higher healthcare costs and an increased risk of poor clinical outcomes, including long-term mortality.
    • “How can care teams work to minimize a patient’s risk of developing POAF? What is the best way to manage POAF once it develops? To answer those very questions, the Society of Thoracic Surgeons (STS) gathered a committee of cardiac surgeons, cardiologists, anesthesiologists and intensivists who specialize in POAF. The group reviewed years of data, including randomized trials and contemporary treatment guidelines, and landed on a total of 15 recommendations for reducing the risk of POAF after cardiac surgery. This included eight preventive strategies, three intraoperative techniques and four postoperative treatments.
    • “The committee’s report, first presented at the STS annual meeting in New Orleans, is now published in full in The Annals of Thoracic Surgery.

From the U.S. healthcare business front

  • Health Exec kindly offers five reasons not to (solely) blame insurance companies for what ails US healthcare.
    • High health insurance premiums are largely driven by high underlying healthcare costs. 
    • Health insurers don’t raise premiums to be mean, greedy or otherwise uncaring. 
    • As a share of premium revenues, health insurers’ profit margins are generally modest.
    • Prior authorization: A necessary ‘evil’ without which things would be worse. 
    • There’s enough blame to go around. 
  • Health Exec reports,
    • “TV viewers of a certain age have a hard time avoiding commercials hawking pharmaceutical and medical products. That category is the second-most heavily advertised on TV. Only entertainment is ahead of it. 
    • “And that’s just TV. Across all media, pharmaceutical companies are spending close to $10 billion per year on direct-to-consumer advertising in the U.S., MediaRadar reports. Only the entertainment industry spends more. 
    • “This kind of drug-pushing is legal, of course. But is it good for the health status of Americans?
    • “There are two schools of thought on that question. One defends a soft yes, the other a hard no. Both get a hearing in a slice of investigative journalism from KFF Health News in partnership with The New York Times.”
  • MedCity News notes
    • “Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian war front,

  • Cybersecurity Dive reports on April 23,
    • “Iran, long considered a steady and persistent cyber threat to the U.S., has raised its game in the months since the two nations went to war in February. 
    • “Iranian-backed cyber threat groups, which range from state-sponsored actors to pro-Iranian hacktivists and financially motivated hackers, appear to have evolved some of their motivations and capabilities in cyber, according to analysts and security researchers. 
    • “What we are seeing are attacks that are aiming to have a more destructive effect,” Annie Fixler, director of the Center on Cyber and Technology Innovation (CCTI) at the Foundation for Defense of Democracies told Cybersecurity Dive. 
    • Specifically, Iran-linked actors have increased the use of data wiping malware in recent attacks against Israel and demonstrated greater capability to evade detection, according to researchers at Palo Alto Networks. 
    • “In another alarming development, Darktrace last week published an analysis of a malware strain called ZionSiphon, to potentially tamper with chlorine levels and pressure controls in Israeli water facilities. The malware was embedded with pro-Iran and Palestinian messaging for additional psychological impact.”
  • Federal News Network commentator shares “what federal leaders need to know about Iran’s cyber campaign.”
    • “To understand the cyber implications of this conflict, federal leaders need to understand how Iran uses cyber as a strategic instrument.”

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “Sean Plankey, the long-sidelined nominee to lead the Cybersecurity and Infrastructure Security Agency, asked President Donald Trump on Wednesday to withdraw his nomination.
    • “At this point in time, I am asking the President to remove my nomination from consideration,” he said in a notification letter seen by CyberScoop. “After thirteen months since my initial nomination, it has become clear that the Senate will not confirm me.”
    • “Plankey’s request comes weeks after the Senate confirmed MarkWayne Mullin to lead the Department of Homeland Security, CISA’s parent agency.”
  • and
    • “House Republicans unveiled on Wednesday Congress’ latest effort to tackle comprehensive digital privacy legislation for Americans.
    • “The Secure Data Act would allow consumers to opt out of data collection for individual businesses for the purposes of targeted advertising, selling to third parties or for use in automated decisionmaking.
    • “It would also require companies to inform consumers when their personal data is being collected or used, provide them with a portable version of that data, and give consent rights to parents over the data collection of teenagers.”
  • Per a NIST news release,
    • “The National Institute of Standards and Technology (NIST), in collaboration with the Department of Health and Human Services Office for Civil Rights (HHS OCR), announced the Safeguarding Health Information: Building Assurance through the Health Insurance Portability and Accountability Act (HIPAA) Security 2026 conference, scheduled for September 2–3, 2026, at the NIST campus in Gaithersburg, Maryland. The event will examine the current healthcare cybersecurity landscape and the HIPPA Security Rule, which establishes federal standards to protect the confidentiality, integrity, and availability of electronic protected health information. The conference will highlight practical strategies, tips, and techniques for implementing the HIPAA Security Rule, including required administrative, physical, and technical safeguards for covered entities and their business associates. Sessions will address best practices for managing risks to electronic health information and ensuring technical assurance, along with topics such as cybersecurity risk management, current threats to the healthcare community, and cybersecurity considerations for Internet of Things technologies in healthcare environments. The event will be offered in both in-person and virtual formats, with separate registration fees and timelines for each option. For additional details, visit the Safeguarding Health Information: Building Assurance through HIPAA Security 2026 event page.”
       
  • Per an April 23, 2026, HHS news release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with four regulated entities following separate ransomware investigations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. Ransomware is malicious software that blocks access to data—typically by encrypting it with a key known only to the attacker—until a ransom is paid. The resolutions announced mark 19 completed investigations from ransomware breaches and 13 completed investigations in OCR’s Risk Analysis Initiative.” * * *
    • “The settlements follow investigations into separate ransomware breaches that collectively affected over 427,000 individuals and involved the exposure of unsecured ePHI. The types of ePHI affected include demographic data, Social Security numbers (SSNs), financial information, lab results, medications, and diagnoses or conditions. Under the settlements, the regulated entities have agreed to implement corrective action plans subject to OCR monitoring for two years and paid a total of $1,165,000 to OCR.”
  • Per an April 20, 2026, Justice Department news release,
    • “A Florida man, formerly employed as a ransomware negotiator, pleaded guilty to conspiring to commit ransomware attacks against U.S. companies in 2023.
    • “According to court documents, Angelo Martino, 41, of Land O’Lakes, Florida, collaborated with the operators of the Blackcat/ALPHV (“BlackCat”) ransomware variant used by cybercriminals to attack and extort institutions and companies. Beginning in April 2023, Martino abused his role at a U.S.-based cyber incident response company to assist BlackCat actors. Working as a negotiator on behalf of five different ransomware victims, Martino provided BlackCat attackers with confidential information about the negotiating position and strategy of his company’s clients without the clients’ or his employer’s knowledge or permission. This confidential information assisted the ransomware actors and maximized the ransoms that the victims were required to pay. The confidential information included the victims’ insurance policy limits and internal negotiation positions. The BlackCat actors paid Martino for this confidential information.” * * *
    • “To date, law enforcement has seized $10 million of assets from Martino, including digital currency, vehicles, a food truck, and a luxury fishing boat that Martino obtained using proceeds of the offense or acquired as a result of the offense.”
  • Cyberscoop adds,
    • “A core leader of the hacker subset of The Com responsible for a series of high-profile phishing attacks and cryptocurrency thefts from September 2021 to April 2023 pleaded guilty to federal charges, the Justice Department said Friday. 
    • “Tyler Robert Buchanan of Dundee, Scotland, pleaded guilty to conspiracy to commit wire fraud and aggravated identity theft. The 24-year-old was arrested by Spanish police in Palma in 2024 as he attempted to board a charter flight to Naples, Italy. 
    • “Buchanan has been in federal custody since April 2025 and faces up to 22 years in federal prison at his sentencing, which is scheduled for August 21. 
    • “The British national and his co-conspirators, including Noah Michael Urban, who was sentenced to a 10-year federal prison sentence last year, harvested thousands of credentials via phishing and stole more than $8 million in cryptocurrency from U.S. residents via SIM-swapping attacks.”

From the cybersecurity breaches and vulnerabilities front,

  • Cybersecurity Dive reports,
    • “The Cybersecurity and Infrastructure Security Agency on Monday [April 20] released guidance related to the axios supply chain compromise originally disclosed in late March. 
    • “A suspected North Korean actor compromised the node package manager account for an axios maintainer last month. Axios is a Javascript library used widely across the software industry with millions of downloads per week. 
    • “CISA is urging security teams to monitor and review code depositories as well as continuous integration/continuous delivery pipelines that ran npm install or npm update on the compromised axios version, according to the guidance released Monday. 
    • “Security teams should search for cached versions of the affected dependencies in artifact repositories along with dependency management tools, according to the guidance. 
    • “If compromised dependencies are found during the search, organizations should revert the environment back to a known safe state, CISA said.” 
  • and
    • “Vercel, a cloud development platform, said that some of its internal systems were accessed after a third-party tool called Context.ai was compromised while being used by one of Vercel’s employees, according to a blog post released Sunday [April 20].
    • “Vercel is widely known as the creator of Next.js, which is the open-source framework for React. 
    • “The attacker was able to take over the employee’s Vercel Google Workspace account and access certain company “environments and environment variables” that were not designated as “sensitive.”
    • “Vercel said that a limited number of customers had their credentials compromised during the attack, and that they have been notified. They were urged to immediately rotate credentials. 
    • “The company said it believes the attacker is highly sophisticated, based on an assessment of their “operational velocity and detailed understanding of Vercel’s systems.”
  • and
    • “Hackers working for the Chinese government are increasingly hiding their attacks behind ready-made networks of hacked routers and other networking equipment, the U.S. and several allies said on Thursday [April 23].
    • “Attackers’ use of these so-called covert networks is not new, the agencies said in a joint advisory, “but China-nexus cyber actors are now using them strategically, and at scale.”
    • “By funneling their activity through compromised networking equipment — mostly small office and home office (SOHO) routers, but also internet of things devices — hackers can obfuscate their origins and make it harder for defenders to spot reconnaissance, malware deployment and data exfiltration.”
  • Cyberscoop adds,
    • “A state-sponsored hacking group has implanted a custom backdoor on Cisco network security devices that can survive firmware updates and standard reboots, U.S. and British cybersecurity authorities disclosed Thursday, marking a significant escalation in a campaign that has targeted government and critical infrastructure networks since at least late 2025.
    • “The Cybersecurity and Infrastructure Security Agency and the United Kingdom’s National Cyber Security Centre jointly published a malware analysis report identifying the backdoor, code-named Firestarter. Cisco’s threat intelligence division, Talos, attributed the malware to a threat actor it tracks as UAT-4356. The company attributed the same group to a 2024 espionage campaign called ArcaneDoor, which focused on compromising network perimeter devices.
    • “CISA confirmed it discovered Firestarter on a U.S. federal civilian agency’s Cisco Firepower device after identifying suspicious connections through continuous network monitoring. The finding prompted an updated emergency directive issued Thursday, requiring all federal civilian agencies to audit their Cisco firewall infrastructure and submit device memory snapshots for analysis by Friday.”
  • CISA added fourteen known exploited vulnerabilities (KVEs) to its catalog this week.
    • April 20, 2026
      • CVE-2023-27351 PaperCut NG/MF Improper Authentication Vulnerability
      • CVE-2024-27199 JetBrains TeamCity Relative Path Traversal Vulnerability
      • CVE-2025-2749 Kentico Xperience Path Traversal Vulnerability
      • CVE-2025-32975 Quest KACE Systems Management Appliance (SMA) Improper Authentication Vulnerability
      • CVE-2025-48700 Synacor Zimbra Collaboration Suite (ZCS) Cross-site Scripting Vulnerability
      • CVE-2026-20122 Cisco Catalyst SD-WAN Manager Incorrect Use of Privileged APIs Vulnerability
      • CVE-2026-20128 Cisco Catalyst SD-WAN Manager Storing Passwords in a Recoverable Format Vulnerability
      • CVE-2026-20133 Cisco Catalyst SD-WAN Manager Exposure of Sensitive Information to an Unauthorized Actor Vulnerability
        • The Cybersecurity Express discusses these KVEs here.
        • Cybersecurity Dive discusses the Cisco KVEs here.
    • April 22, 2026
      • CVE-2026-33825 Microsoft Defender Insufficient Granularity of Access Control Vulnerability
        • Bleeping Computer discusses this KVE here.
    • April 23, 2026
      • CVE-2026-39987 Marimo Remote Code Execution Vulnerability
        • Resecurity discusses this KVE here.
    • April 24, 2026
      • CVE-2024-7399 Samsung MagicINFO 9 Server Path Traversal Vulnerability
      • CVE-2024-57726 SimpleHelp Missing Authorization Vulnerability
      • CVE-2024-57728 SimpleHelp Path Traversal Vulnerability
      • CVE-2025-29635 D-Link DIR-823X Command Injection Vulnerability 
        • The Hackers News discusses these KVEs here.
  • Cybersecurity Dive informs us,
    • “Phishing was the most common way hackers breached their targets in the first quarter of 2026, after nearly a year out of the top spot, Cisco’s Talos threat intelligence team said in a report published on Wednesday.
    • “Nearly 20% of Cisco’s incident-response engagements involved the preliminary stages of a ransomware attack, according to the report — significantly lower than in the first two quarters of 2025, when it was 50%.
    • “Cisco also said it saw hackers using AI to improve phishing attacks.”
  • and
    • “Companies using AI to write code are creating serious security risks that not all organizations feel prepared to handle, according to a reportreleased Wednesday by the security testing firm ProjectDiscovery. 
    • “Security personnel want audit trails and access limitations before they integrate AI into their processes, ProjectDiscovery found. “They are not opposed to the technology, but they need it to earn its place.”
    • “The report highlights one of the most fraught aspects of the AI revolution in the corporate world: the tension between AI-assisted coders and the people responsible for protecting their work.”
  • Dark Reading points out,
    • “AI agents can now carry out end-to-end cloud attacks with minimal human guidance, exploiting known misconfigurations and vulnerabilities at a speed no human attacker can match. 
    • “That’s the central finding of a new proof-of-concept (PoC) study by Palo Alto Networks’ Unit 42, where researchers built an autonomous multi-agent system that carried out a complete cloud attack chain in a live environment, using a single natural-language prompt.
    • “The study suggests an intrusion campaign that Anthropic uncovered last year, when a Chinese state-affiliated cyber-espionage group used the company’s Claude AI to automate large portions of an attack chain, was more a preview of things to come rather than an exception.”
  • Cyberscoop notes,
    • “Attackers rarely exploit an edge-device vulnerability indiscriminately. Typically, they first test how widely the flaw can be used and how much access it can provide, then move on to steal data or disrupt operations.
    • “Pre-attack surveillance and planning leaves a lot of noise in its wake. These signals — particularly spikes in traffic that are hitting specific vendors — can act as an early-warning system, often preceding public vulnerability disclosures, according to research GreyNoise shared exclusively with CyberScoop prior to its release. 
    • “Roughly half of every activity surge GreyNoise detected during a 103-day study last winter was followed by a vulnerability disclosure from the same targeted vendor within three weeks, GreyNoise said in its report.
    • “Researchers determined that the median warning of an impending vulnerability disclosure arrived nine days before the targeted vendor issued a public alert to its customers.”

From the ransomware front,

  • Bleeping Computer reports,
    • “Home security giant ADT has confirmed a data breach after the ShinyHunters extortion group threatened to leak stolen data unless a ransom is paid.
    • “In a statement shared today, the company said it detected unauthorized access to customer and prospective customer data on April 20, after which it terminated the intrusion and launched an investigation.
    • “This investigation determined that personal information was stolen during the breach.”
    • “The investigation confirmed that the information involved was limited to names, phone numbers, and addresses,” ADT told BleepingComputer.
    • “In a small percentage of cases, dates of birth and the last four digits of Social Security numbers or Tax IDs were included. Critically, no payment information — including bank accounts or credit cards — was accessed, and customer security systems were not affected or compromised in any way.”
  • and
    • “Recently observed Trigona ransomware attacks are using a custom, command-line tool to steal data from compromised environments faster and more efficiently.
    • “The utility was emplayed in attacks in March that were attributed to a gang affiliate, likely in an effort to avoid publicly available tools, such as Rclone and MegaSync, that typically trigger security solutions.
    • “Researchers at cybersecurity company Symantec believe that the shift to a custom tool may indicate that the attacker is “investing time and effort in proprietary malware in a bid to maintain a lower profile during a critical phase of their attacks.”
  • and
    • “A new Kyber ransomware operation is targeting Windows systems and VMware ESXi endpoints in recent attacks, with one variant implementing Kyber1024 post-quantum encryption.
    • “Cybersecurity firm Rapid7 retrieved and analyzed two distinct Kyber variants in March 2026 during an incident response. Both variants were deployed on the same network, with one targeting VMware ESXi and the other focusing on Windows file servers.
    • “The ESXi variant is specifically built for VMware environments, with capabilities for datastore encryption, optional virtual machine termination, and defacement of management interfaces,” explains Rapid7.”
  • Dark Reading relates,
    • “A ransomware gang known as “The Gentlemen” has made a name for itself, claiming hundreds of victims in a matter of months.
    • “The Gentlemen is a ransomware-as-a-service (RaaS) outfit that first popped up in mid-2025. While it operates fairly typical double extortion attacks (using both encryption and data leaking as extortion levers), The Gentlemen is known for sophisticated tactics, techniques, and procedures (TTPs), such as antivirus killers and complex infection chains.
    • “Check Point Research this week published its latest findings concerning the gang, noting that it has claimed hundreds of victims and uses malware including something called SystemBC, which researchers described as “a proxy malware frequently leveraged in human‑operated ransomware operations for covert tunneling and payload delivery.”

From the cybersecurity defenses front,

  • TechTarget discusses,
    • “Beyond awareness: Human risk management metrics for CISOs
    • “Traditional security training isn’t keeping threat actors out. As employee awareness programs fall short, Forrester Research suggests a better approach.” * * *
    • “With cybersecurity threats evolving so swiftly, organizations cannot afford to rely on outdated security awareness programs that fail to address the root causes of human vulnerabilities. Human risk management offers a transformative approach, shifting the focus from mere awareness to actionable behavior change.”
  • Dark Reading points out,
    • “When Anthropic announced Project Glasswing this month, most coverage landed on the headline numbers: a 27-year-old OpenBSD vulnerability, a 16-year-old FFmpeg flaw, a Linux kernel exploit chain assembled without human steering. The coalition behind it, including AWS, Apple, Cisco, CrowdStrike, Google, Microsoft, Palo Alto Networks, and others, isn’t there for the optics; they’re there because the model’s capabilities are real, and the coordinated disclosure pipeline matters.
    • “The part worth dwelling on is the FFmpeg result specifically. At least five million automated fuzzer testing passes hit that vulnerable line of code and not one caught it. Mythos Preview read the code, understood what it was doing, and found the flaw.
    • That gap highlights a fundamental security misconception of the past two decades.
    • The industry built enumerators. It needed readers.
    • Automated security tooling has almost always worked the same way at its core: define a pattern, scan to identify the pattern, flag the match. SIEMs ingest event logs and match rules. Static analysis tools check code against known signatures. Vulnerability scanners compare software versions against CVE databases, and so on. These are mostly based on enumeration, and enumeration can only find what you already know to look for.
    • “Five million passes with the industry standard tools, zero catches. These tools knew how to count. But they didn’t know how to read.
    • “Mythos Preview succeeded because it approached the code the way a skilled human analyst would: with an understanding of intent, of relationships between components, of what a sequence of operations does, rather than what it superficially looks like. Security at that depth has been the exclusive domain of rare, expensive human expertise. A model that replicates it at scale is genuinely a different kind of thing, and the industry is right to pay attention.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, Patient safety, U.S. Healthcare–

From Washington, DC

  • The Thompson Hine law firm tells us,
    • “The Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) recently released their 2025 Report to Congress on enforcement activity under the Mental Health Parity and Addiction Equity Act (“MHPAEA”).” * * *
    • “Both the DOL and the Centers for Medicare & Medicaid Services (CMS) issued more requests for comparative analyses signaling that enforcement was active in the two year period.” * * *
      • “Employers should continue to pay careful attention to the following specific types of NQTLs that continue to draw the most scrutiny from the Departments:
      • “Provider network admission standards,
      • “Prior authorization requirements,
      • “Concurrent care review requirements, and
      • “Exclusions of key mental health and substance use disorder treatments (such as ABA therapy, methadone maintenance treatment, and nutritional counseling for eating disorders).”
  • Healthcare Dive reports,
    • “A pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare is delaying care for seniors in Washington, according to a report released Wednesday by one of the state’s Democrat senators. 
    • “Under the WISeR program, procedures that were previously approved within about two weeks now take four to eight weeks to be authorized, according to survey data from the Washington State Hospital Association.
    • ‘The pilot is creating increased administrative work for providers in the state, as well as potentially worsening health outcomes for patients whose care is delayed, the report released by Sen. Maria Cantwell, D-Wash., found. “It’s not taking a few days to find out whether you’re going to get covered or not,” Cantwell said during a Senate Finance Committee hearing Wednesday. “It’s basically taking weeks to find out you were denied.”
  • KFF News relates,
    • “More than 12 million people — about 43% of those in traditional Medicare [including the FEHBlog] — buy a Medigap policy. Others rely on some sort of retiree employer coverage or a different backup. About 13% of people in traditional Medicare don’t have supplemental coverage, according to KFF, meaning they could be vulnerable to large costs if they have a serious illness.
    • “In the supplemental market, following big increases last year, rates appear to be rising again. In early 2026 filings with state insurance commissioners from Aetna, Blue Cross Blue Shield, Cigna, Humana, Mutual of Omaha, and UnitedHealthcare, rate increases for Plan G policies — the most commonly purchased supplement type — ranged from just over 12% to more than 26% in the first quarter, according to Nebraska-based consulting firm Telos Actuarial.
    • “While this is a small dataset across a select number of states, it’s an indication that carriers are looking to correct their premium rates in light of upward pressure on their claims experience,” said Brett Mushett, a consulting actuary with Telos.”
  • Contemporary OB/GYN lets us know,
    • “The American Medical Association (AMA) and the Current Procedural Terminology (CPT) Editorial Panel have approved a comprehensive restructuring of maternity care services codes, marking a departure from the long-standing global payment model, according to an announcement from the Association. 
    • “Beginning January 1, 2027, the CPT code set will transition to a granular framework that replaces the traditional bundled payment model with codes that accurately represent 4 distinct phases of care: 
      • “Antepartum 
      • “Labor management 
      • “Delivery 
      • “Postpartum.
    • “This transition follows nearly 2 years of collaborative efforts between the AMA, the American College of Obstetricians and Gynecologists (ACOG), and various national medical specialty societies. By moving away from the legacy global model, which historically reported maternity care as a single service, the new structure is designed to reflect the realities of modern, team-based obstetric practice, a change that ACOG is welcoming.” * * *
    • “To facilitate this transition, the AMA is releasing the 2027 codes ahead of the standard schedule to ensure that physicians, payers, and EHR vendors have sufficient time to prepare. ACOG and the AMA have developed several educational resources to support clinicians through this transition as they move toward a framework that supports improved transparency and risk adjustment.¹
    • “You can view and download these codes via the AMA website, here.”
  • The American Hospital Association News informs us,
    • “The AHA April 24 urged the Sequoia Project to delay implementation of the Trusted Exchange Framework and Common Agreement Individual Access Services Exchange Purpose Standard Operating Procedures version 3.0 until key legal and regulatory issues are resolved. The proposed IAS SOP, slated for implementation by August 2027, includes new patient-matching methodologies that bypass or limit provider verification, which the AHA argues could expose hospitals to unauthorized disclosures, data breaches and misidentification errors. 
    • “The AHA emphasized that hospitals and health systems are already legally bound to verify identity, consent and authority before disclosing protected health information, warning that the proposed IAS SOP does not adequately account for these statutory obligations, creating significant compliance and liability risks for covered entities. To address the risks, the AHA recommended delaying the SOP and pursuing statutory or regulatory solutions, such as a provider safe harbor or clear regulatory guidance confirming compliance with IAS satisfies the Health Insurance Portability and Accountability Act verification and consent requirements.” 

From the Food and Drug Administration front,

  • The American Hospital Association News reports,
    • “The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to treatments for serious mental illness. The agency said it will prioritize development and review of serotonin-2A agonists for conditions such as treatment-resistant depression, post-traumatic stress disorder and substance use disorders, including issuing national priority vouchers for studies of the drugs psilocybin and methylone for alcohol use disorder. The FDA also noted it would aim to balance urgency with rigorous science and to expect final guidance for study sponsors soon.” 

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19
      • COVID-19 activity is low in most areas of the country.
    • “Influenza
      • Seasonal influenza activity continues to decrease. Influenza A activity is low across all regions and influenza B activity continues to trend downward.
      • Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. RSV activity has peaked in many regions of the country. This unusual timing means higher levels of RSV activity may continue through April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • National vaccination coverage for COVID‑19, influenza, and RSV remained low among both adults and children. COVID-19, influenza, and RSV vaccines can provide protection against severe disease. Talk to your doctor or trusted healthcare provider about what vaccines are recommended for you and your family.
  • The American Hospital Association News reports,
    • “The Utah measles outbreak has increased to 607 cases, the state’s Department of Health and Human Services reported April 24. Nationwide, there have been 1,792 confirmed measles cases so far in 2026, according to the latest data from the Centers for Disease Control and Prevention. Of those, 93% of cases are outbreak-associated, and 6% of cases have been hospitalized. The vaccination status of 92% of cases is unvaccinated or unknown.”
  • The Hill relates,
    • “With spring in full force and summer on the way, the Centers for Disease Control and Prevention (CDC) is raising the alarm on tick bites.
    • “The agency says the bites are sending Americans to the emergency room(ER) at the highest rate in nearly 10 years. 
    • “During the second week of April, 71 out of every 100,000 emergency room visits were for tick bites, according to the CDC.
    • “The administration’s data notes that the Northeast region of the country has seen the largest spike in ER visits, followed by the Midwest.
    • “To avoid potential tick bites, the CDC recommends steering clear of wooded and brushy areas with high grass and leaf litter. They also advise checking animals that go outside every day during warm weather.”
  • The University of Minnesota’s CIDRAP tells us,
    • “Transmission of clade 1 mpox virus during commercial air travel appears to be uncommon, according to a study published yesterday [April 23] in Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention (CDC).” 
  • The American Medical Association lets us know what doctors wish patients knew about cervical cancer prevention.
  • MedPage Today points out,
    • “The epidemiology of sudden cardiac deaths (SCDs) was turned on its head Thursday, with research showing that in reality, ischemic cardiac disease is not the leading driver of SCDs, as previously thought.
    • “From a prospective autopsy study of unselected deaths in San Francisco County, California, it was evident that out of 943 presumed SCDs, 62% were autopsy-confirmed, and only 41% of those were due to myocardial infarction (MI) upon comprehensive postmortem and histologic evaluation — “one-half the long-accepted 80% prevalence among SCDs,” according to Zian Tseng, MD, MAS, of University of California San Francisco, and colleagues of the POST SCD study.
    • “For the remaining 59% of autopsy-confirmed SCDs not traced to an MI, they can be explained by a range of causes including hypertensive heart disease, dilated cardiomyopathy, substance-related cardiomyopathy, and normal heart primary electrical disease. When an MI was involved, nine in ten cases were attributed to acute or healed MI with obstructive coronary artery disease, and one in ten related to acute MI with nonobstructive coronary arteries (MINOCA).
    • “The study was presented at the annual meeting of the Heart Rhythm Society (HRS), held in Chicago this year. A full manuscript was published in the Journal of the American College of Cardiology.”
  • Per a National Institutes of Health news release,
    • “A large clinical trial supported by the National Institutes of Health (NIH) compared two commonly used treatments for pediatric patients treated for septic shock and found no difference in meaningful outcomes. The trial, which enrolled over 9,000 participants across five countries, sought to answer a longstanding question about which intravenous crystalloid fluid type was the superior option for children who were in septic shock, a life-threatening condition triggered by severe infection which requires immediate medical treatment.
    • “For decades, pediatricians have debated which is the best intravenous resuscitation treatment for children with severe infections who have suspected septic shock,” said Rohan Hazra, M.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study. “This largest-ever clinical trial for children treated for septic shock has immediate clinical application and allows physicians caring for these vulnerable patients to know they can confidently choose either intervention as a standard of care.”
  • Per Medscape,
    • “New drugs approved in 2025 are poised to significantly improve the management of motion sickness, acute pain, urinary tract infections (UTIs), and chronic spontaneous urticaria.
    • “Gerald W. Smetana, MD, a professor emeritus of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, talked about new treatments in a presentation at the American College of Physicians Internal Medicine (ACP-IM) Meeting 2026 in San Francisco.
    • “This is the first time in my 15-year history of giving this new drugs talk that I’ve given all four drugs a thumbs-up, with the potential to change practice,” Smetana said during his presentation.”
  • Per Health Day,
    • “For adults with type 2 diabetes (T2D), a ketogenic diet (KD) reduces the proportion of proinsulin secreted to a greater extent than a low-fat diet (LFD), according to a study published online April 21 in the Journal of the Endocrine Society.” * * *
    • “We showed that three months of a ketogenic diet was able to improve beta-cell function in patients with T2D, and these improvements were associated with changes in the PICP ratio, a biomarker of pancreas stress,” Yurchishin said in a statement. “Other than bariatric surgery or large-volume intentional weight loss, interventions for improving beta-cell function in T2D do not currently exist.”
  • The Wall Street Journal notes,
    • “A health-tech startup, NewDays, developed an AI chatbot named Sunny to help people with dementia practice communication skills.
    • “NewDays’ service combines telehealth visits with bot practice; a study found seven of nine patients showed cognitive improvement.
    • “A clinical trial, on which NewDays’ therapy is based, found participants had higher cognitive scores than the control group.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “U.S. health insurers are accelerating efforts to streamline prior authorization requirements, with UnitedHealthcare, Aetna and Cigna on Friday detailing progress toward industry commitments aimed at reducing administrative burdens and speeding patient access to care.
    • “UnitedHealthcare said more than half of its prior authorization volume will be incorporated into a standardized electronic submission process, with that share expected to exceed 70% by the end of 2026.
    • “Aetna, a unit of CVS Health CVS -1.59%decrease; red down pointing triangle, said it has already standardized 88% of its prior authorization volume. The company also said it is processing 83% of requests in real time, ahead of a 2027 goal set by insurers, and that more than 95% of eligible requests are approved within 24 hours.
    • “Cigna said it expects to standardize electronic prior authorization submission requirements for more than 70% of volume by the end of the year.
    • “All the companies emphasized the use of automation and digital tools to reduce administrative friction for providers. Aetna said it has eliminated more than 1 million provider calls through automation, while UnitedHealthcare highlighted efforts to reduce documentation requirements and limit the need for follow-up information.”
  • Fierce Healthcare relates,
    • “HCA Healthcare executives worked to reassure investors that lower-than-expected patient volumes during the first quarter are in the past and not expected to diminish the company’s full-year growth targets. 
    • “In quarterly numbers released Friday morning and discussed during an earnings call, the executives focused on two curveballs—a sharp end to the flu season and disruptive winter storms—which said were almost entirely offset by unexpected receipt of Medicaid state supplemental payments. 
    • “Specifically, the quarter’s respiratory-related admissions declined 42% year-over-year while respiratory-related emergency room visits were down 32%, translating to a 70 basis point drag for the former and a 140 basis point dip for the latter. In Texas, Tennessee, North Carolina and Virginia, the inclement weather reduced admissions and ER visits by 30 basis points and 50 basis points, respectively. 
    • “The two factors hit volumes across payer categories and resulted in an estimated $180 million hit to HCA’s adjusted EBITDA, they said. 
    • “On the other hand, an expected $80 million net benefit increase to adjusted EBITDA compared to Q1 2025 related to the supplemental payments was, in reality, about $200 million, thanks to program approvals and reinstatements in Georgia and Texas.” 
  • Kaufmann Hall adds,
    • “Kaufman Hall’s latest National Hospital Flash Report underscores persistent cost pressures that continue to strain hospital and health system finances. Calendar year-to-date margins adjusted for corporate allocations declined at the start of the year. Operational shifts—fewer inpatient days, greater reliance on outpatient revenue, and softer, uneven volumes—reflect an ongoing transition in where and how care is delivered.”
  • MedTech Dive tells us,
    • “Edwards Lifesciences increased its full-year financial forecast as sales of its transcatheter aortic replacement valves grew at a faster-than-expected pace in the first quarter.
    • “Edwards CEO Bernard Zovighian said on a Thursday earnings call that the upturn in first-quarter TAVR sales reflects a move away from watchful waiting in clinical practice for patients with severe heart valve disease.
    • “There has been a shift toward proactive disease management with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway,” Zovighian told analysts and investors.
    • “He said heart patients are being referred for valve replacement sooner due to the company’s study data that points to better outcomes with earlier treatment and the long-term durability of its Sapien valves. It was Edwards’ third consecutive quarter of double-digit TAVR sales growth.”
  • The Wall Street Journal cautions,
    • “After months of dizziness and arms aching so badly, she could barely walk her dog, Susan Glannan lay stunned in a sunny hospital room as a doctor told her she should have open heart surgery. 
    • “The idea of a surgeon cracking her chest open and stopping her heart terrified her. Glannan, who was 64, lived alone. She didn’t have her affairs in order. And just four years earlier, she had had a procedure that she thought would take care of her heart problem—a diseased aortic valve. “I was disappointed and scared,” she said, “and I started worrying, ‘Do I have a will?’” 
    • “That first procedure was called a transcatheter aortic valve replacement, or TAVR. It’s considered one of the biggest innovations in cardiovascular medicine, offering a way to spare patients the physical and emotional trauma of open heart surgery.
    • “TAVR was approved in 2011 for frail, older patients unlikely to withstand surgery—people with no more than a few years left to live. The Food and Drug Administration later approved it for healthier patients at intermediate and low risk of dying from surgery.
    • “Yet there’s limited research on how long the valves might last. And as TAVR has become more widely used among younger and healthier people, some are finding that their valves don’t work as well or last as long as they hoped. The procedure they thought would spare them a complicated surgery leads some to the operating table anyway.”

Thursday report

David Ermer–ACA, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association News reports,
    • “The Senate April 23 adopted a budget resolution by a 50-48 vote, paving the way for a narrow reconciliation bill focused on immigration enforcement funding. Congressional Republicans are seeking to use the reconciliation process primarily to end the partial shutdown of the Department of Homeland Security. The resolution instructs the Senate Homeland Security and Governmental Affairs Committee, the Senate Judiciary Committee, and the House Homeland Security and Judiciary committees to write legislation by May 15 that provides up to $70 billion in funding.  
    • “The vote followed a lengthy “vote-a-rama” session overnight that consisted of multiple proposed amendments from Democrats that failed to pass. Both chambers must pass a common budget resolution to move forward with the reconciliation process. Legislative action is expected in the House as early as next week.”  
  • STAT News reports,
    • “President Donald Trump’s acting attorney general on Thursday signed an order reclassifying state-licensed medical marijuana as a less-dangerous drug, a major policy shift long sought by advocates who said cannabis should never have been treated like heroin by the federal government.
    • “The order signed by Todd Blanche does not legalize marijuana for medical or recreational use under federal law. But it does change the way it’s regulated, shifting licensed medical marijuana from Schedule I — reserved for drugs without medical use and with high potential for abuse — to the less strictly regulated Schedule III. It also gives licensed medical marijuana operators a major tax break and eases some barriers to researching cannabis.
    • “The Trump administration also said it was jump-starting the process for reclassifying marijuana more broadly, setting a hearing to begin in late June.”
  • The Wall Street Journal tells us “What to Know About the Health Risks of Marijuana.”
    • “Studies show the drug can exacerbate anxiety and teen use poses risks for developing brains.”
  • STAT News adds,
    • “President Trump heralded a drug pricing agreement with Regeneron on Thursday, closing the last of 17 deals initially sought by the White House last year.
    • “Regeneron, as part of the private deal, will reduce prices on drugs to Medicaid, provide cholesterol medicine Praluent on TrumpRx for $225, and invest $27 billion in drug development in the United States.”
  • Tammy Flanagan, writing in Govexec, lets us know,
    • “I was planning to write about the number of TSP millionaires for this week’s column — until I started getting messages from former federal employees, all who retired on September 30, 2025, and are still waiting for their retirement benefit from the Office of Personnel Management (OPM) to be finalized.
    • “It is not completely surprising that retirement processing has slowed down, and for some former employees, they continue to wait for their retirement benefits to be finalized. But for the employees who have reached out for assistance, many have not received any money since their last paycheck was received in October 2025.
    • “It has been almost six months with very little or, in some cases, no money and little communication to help them understand how long they will have to continue to wait.” * * *
    • “In my experience, retirement processing is less like flipping a switch and more like closing out a file with dozens of tabs. One missing document or unresolved question can stop forward progress.
    • “Common culprits include late or incomplete payroll certifications, missing service history, unposted deposits or redeposits for prior service, unresolved military service credit, periods of leave without pay that need to be documented, name discrepancies, incomplete beneficiary or survivor elections, or court orders that require special handling.
    • “None of these problems are rare, and when thousands of cases arrive at once, the odds go up that more people land in the exception pile.”
    • Tammy then make suggestion on steps to take.

From the Food and Drug Administration front,

  • Healthcare Dive reports,
    • “The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
    • “The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
    • “The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.”
  • The Wall Street Journal relates,
    • “Children born deaf because of a rare condition can now take a drug to restore their hearing after a gene therapy was approved in the U.S., ushering in a new era for the treatment of an inherited form of hearing loss. 
    • “The Food and Drug Administration approved Regeneron Pharmaceuticals’drug Otarmeni for children born with a faulty gene that plays a role in hearing. It targets a rare condition affecting an estimated 20 to 50 newborns in the U.S. each year and could eventually be expanded to an even wider population if additional studies succeed.
    • “In my wildest dreams I never thought we’d be here in my lifetime,” said Lawrence Lustig, a hearing specialist at Columbia University Irving Medical Center who helped lead the trial.
    • “Regeneron said it would offer the drug free to people in the U.S.”
  • MedTech Dive tells us,
    • “Tandem Diabetes Care issued an urgent medical device correction for a software problem with its Mobi insulin pumps.
    • “The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. 
    • “Tandem sent a letter to customers in October notifying them of the fault and instructing them to update their pump software as soon as possible. Tandem had reported four serious injuries related to the problem as of Nov. 4.”

From the judicial front,

  • Modern Healthcare reports,
    • “The Federal Trade Commission has reached an agreement in principle with U.S. Anesthesia Partners to settle the government’s 2023 lawsuit. 
    • “The terms of the preliminary settlement are confidential so USAP can carry out the negotiations necessary to fulfill them, the FTC said in a Thursday news release.
    • “The agency in its original complaint claimed the anesthesiology group allegedly violated antitrust laws and reduced competition for anesthesia services in Texas. The preliminary settlement resolves the charges, the FTC said Thursday.” 
  • The New York Times points out “A $440,000 Breast Reduction: How Doctors Cashed In on a Consumer Protection Law.”
    • A law meant to end surprise medical billing accidentally created a multibillion-dollar industry that is making doctors richer.”
  • FEHBlog observation – This is happening. Why can’t Congress and the regulators fix the problem?

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk will seek regulatory approval for its semaglutide pill to treat Type 2 diabetes in children and adolescents after a late-stage trial showed it significantly reduced blood sugar in 10- to 17-year-olds.
    • “The once-daily semaglutide pill is currently marketed as Rybelsus in the EU and U.S. to treat diabetes in adults and will be available in the U.S. as Ozempic pill later in the second quarter. It is not currently approved for use in children or adolescents.
    • “The Danish drugmaker said Thursday that oral semaglutide has the potential to be the first oral GLP-1 to demonstrate a superior reduction in blood sugar levels compared with a placebo in children and adolescents with Type 2 diabetes, while maintaining the well-tolerated safety profile seen across other semaglutide trials.
    • “Over the past two decades, the prevalence of Type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need,” said Martin Holst Lange, Novo Nordisk’s chief scientific officer and head of research & development.”
  • MedPage Today relates,
    • “An investigational benzamide antipsychotic significantly improved symptoms in hospitalized adults with acute schizophrenia in a phase II trial.
    • “The drug, N-methyl amisulpride, is similar to its predecessor, amisulpride, but has some key differences in dosing and side effects.
    • “Because of the 4-week trial duration, long-term treatment durability wasn’t evaluated.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Diabetes affects over half a billion people globally. Along with direct consequences to those with the disease, it also contributes to and predisposes affected individuals to a host of other conditions. Specifically, it is a known contributing factor in the development of vascular disease, including peripheral artery disease. While therapies exist, they are not very effective, and peripheral artery disease can lead to restricted blood flow in peripheral limbs, which sometimes leads to amputation. Understanding the mechanism driving the connection at the tissue and cellular level has the potential to improve therapy options and the development of new treatments.
    • “Normal function of the peripheral vasculature requires communication and cooperation between the vascular endothelium and macrophages. “Monocytes patrol the vascular endothelium and remove damaged cells, and intimal-resident macrophages maintain a nonthrombogenic endothelial state,” wrote the authors of a study led by Zhen Chen, PhD, at City of Hope. They explained that under stress, macrophages can modulate vascular remodeling and in certain conditions, like cancer, they “can secrete inflammatory mediators to disrupt endothelial cell tight junctions and increase endothelial cell permeability.”
    • “The team decided to explore the cellular cross-talk between macrophages and endothelial cells, as well as the resulting vascular function, to better understand the mechanisms behind peripheral artery disease induced by diabetes.
    • “They published their work in a paper titled “Diabetes-induced TREM2–endothelial cell signaling impairs ischemic vascular repair” in Science Translational Medicine.“
  • Healio tells us,
    • “Influenza vaccination continues to protect children from influenza-related outpatient visits and hospitalizations, according to post-pandemic data published in Pediatrics.
    • “We have had really severe recent seasons for flu, particularly in children,” Samantha M. Olson, MPH, an epidemiologist in the CDC’s influenza division, told Healio in an interview. “This study really adds to the growing body of evidence showing how protective flu vaccines can be for infants, children and adolescents, and this includes even the most severe outcomes.”
  • and
    • “People taking GLP-1s had reduced risk for atrial fibrillation, regardless of whether they lost weight or how much they lost, according to findings presented at Heart Rhythm 2026.
    • “We were prompted to undertake this study by some encouraging data that … GLP-1 receptor agonists seem to have a favorable effect on reducing the incidence of atrial fibrillation, particularly in patients with metabolic risk factors,” Kenneth C. Bilchick, MD, MS, professor of cardiovascular medicine at the University of Virginia School of Medicine, who presented the findings, told Healio. “I think the results were expected, but they were even better than we thought they would be.”
  • Health Day informs us,
    • For many women, a sudden sneeze or a hearty laugh bring an unwelcome consequence: A small leak of urine. 
      Often dismissed as a normal part of aging or motherhood, new research suggests the real culprit may lie deep within the abdomen.
      A study from the Federal University of São Carlos (UFSCar) in Brazil found that hidden fat stored between internal organs is a major driver of stress-induced urinary incontinence.
      The research — published recently in the European Journal of Obstetrics & Gynecology and Reproductive Biology — suggests that where a woman carries her weight matters far more than the number on the scale.
      Stress urinary incontinence occurs when everyday actions like coughing, lifting or exercising put too much pressure on the bladder, causing urine to leak.
      “It’s that urinary leakage that occurs when pressure inside the abdomen increases and the pelvic floor can’t hold it in,” Patricia Driusso said in a news release. She’s a professor of physical therapy at UFSCar.

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

  • Healthcare Dive reports,
    • “Molina benefited from better controlled Medicaid spending in the first quarter, though steeper membership losses than expected raise questions about whether the insurer can keep costs in hand for the remainder of 2026.
    • “Molina posted better-than-expected first quarter earnings on Wednesday afternoon, sending the insurer’s stock up more than 10% in Thursday morning’s trade.
    • “Yet, unlike its peers UnitedHealth and Elevance, which both raised 2026 guidance after keeping medical spending in check, Molina elected to reaffirm its outlook.
    • “Executives said retaining the current 2026 guidance is prudent given it’s early in the year and the cost environment remains challenging. Still, they hinted Molina might update the outlook after the second quarter.”
  • Fierce Healthcare relates,
    • “Elevance Health’s top brass told investors Wednesday that the insurer is on pace to end the second quarter of 2026 with about 1.2 million members in its individual market plans.
    • “CEO Gail Boudreaux said on the company’s earnings call that the company saw “moderately stronger retention” in the Affordable Care Act segment through Q1, and that it was one of the contributing factors to its better-than-expected results in the quarter.
    • “The membership growth in the individual market plans reflected a shift toward bronze tier coverage following the expiration of enhanced premium tax credits at the beginning of this year, said Chief Financial Officer Mark Kaye. Part of why this trend contributed to lower medical costs is that utilization in these plans is frequently backloaded, he said.” * * *
    • “Kaye said that the company feels good about its position in the ACA market, and the shift to bronze tier plans has been positive in certain markets. However, the company is still taking a prudent approach to forecasting around the ACA market.”
  • Beckers Hospital Review identifies “eight health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service in 2026.”
  • MedTech Dive tells us,
    • “Boston Scientific slashed its 2026 sales growth and earnings guidance on Wednesday as key businesses are facing challenges and setbacks.
    • “The medtech company expects full-year sales growth in a range of 7% to 8.5%, down from a range of 10.5% to 11.5% given in February. Boston Scientific also lowered its adjusted earnings per share guidance from a range of $3.43 to $3.49 to a range of $3.34 to $3.41.
    • “CEO Mike Mahoney told investors on an earnings call that the lowered guidance reflects challenges in several prominent businesses, including electrophysiology and the company’s Watchman franchise.
    • “This was a guide down that we, quite frankly, are not proud of, but we think it’s the right thing to do, and best reflects the current environment,” Mahoney said.”
  • Beckers Health IT informs us,
    • “OpenAI has introduced ChatGPT for Clinicians, offering free use of the tool to all verified U.S. physicians, nurse practitioners, physician assistants and pharmacists.
    • Here are [four] things to know from an April 22 news release and past Becker’s reporting:
      • “1. The AI developer said the solution can help clinicians with tasks like documentation, writing and medical research, freeing up time for patient care.
      • “2. OpenAI has previously launched ChatGPT for Healthcare, an enterprise solution for health systems, and ChatGPT for Health, a tool for users to ask health-related questions.
      • “3. The company also debuted HealthBench Professional⁠, a benchmarking application for three use cases: care consultation, documentation and writing, and medical research.
      • “4. OpenAI said its physician advisors review the AI’s healthcare responses “every few minutes” and before releasing ChatGPT for Clinicians tested nearly 7,000 conversations in their daily work, rating 99.6% of responses as accurate and safe.”
  • Healthcare Dive adds,
    • “The American Medical Association is urging Congress to create safety guardrails for artificial chatbots in mental healthcare, as Americans increasingly turn to the technology for health information and advice. 
    • “In letters sent Wednesday to the chairs of three congressional committees on digital health and AI, the major physician lobby said “well-designed, purpose-built” tools could help patients who would otherwise struggle to access mental healthcare, but that the lack of safety protocols poses serious risks.
    • “Privacy concerns, risks of emotional dependency on AI and reports the tools could encourage self-harm signal that “immediate attention is required to ensure these tools do not inadvertently harm individuals seeking mental health support or companionship,” AMA CEO Dr. John Whyte wrote.”

Midweek report

David Ermer–Congress, FDA, Generative AI, Mental health care, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC,

  • Per a House of Representatives news release,
    • “Today, the House Appropriations Committee met to consider the Fiscal Year 2027 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 34 to 28.” * * *
    • “A summary of the bill is available here.” * * *
  • Federal News Network adds,
    • “The prospects of a civilian federal pay raise next year are continuing to diminish, after House appropriators made no mention of a pay increase in their 2027 spending legislation.
    • “The House Appropriations Committee’s financial services and general government (FSGG) bill for fiscal 2027, which advanced along party lines Wednesday evening, says nothing on funding for a civilian pay raise. Although not yet final, that increases the chances federal employees will miss out on a salary increase next year.”
  •  A House Education and Labor subcommittee shared the testimony presented to its members during its PBM business model hearing today.
  • The Wall Street Journal offers seven takeaways from HHS Secretary Robert F. Kennedy Jr.’s numerous recent appearances before Congressional committees.
  • Healthcare Dive informs us,
    • “Prices for some healthcare services after arbitration under the No Surprises Act were much higher than the same in-network commercial prices before the law was passed, according to new research out this week.
    • “In 2024, prices for imaging after arbitration were 767% higher than average prices in Medicare. For comparison, the same imaging prices were roughly 200% higher than Medicare prices before the No Surprises Act was passed, according to an analysis published by the Brookings Center on Health Policy.
    • “Arbitration decisions in emergency care, imaging and pediatric critical care tended to skew more closely to amounts that providers offered during negotiations, rather than those offered by insurers, according to the analysis.” * * *
    • [This] Brookings research compliments other studies that have found the No Surprises arbitration process raises healthcare costs. One study published in Health Affairs last year found that IDR created an estimated $5 billion in costs between 2022 and 2024, which could eventually result in higher insurance premiums for consumers.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), is today announcing the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health. As part of the Trump Administration’s Executive Order to Accelerate Medical Treatments for Serious Mental Illness, EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.”
  • MedPage Today adds,
    • “From July 2022 [when the 988 mental health line was launched] through December 2024, 35,529 suicides among individuals ages 15 to 34 were observed compared with 39,901 expected suicides based on trends before the launch of the lifeline, corresponding to an 11% reduction (95% CI 8.7-13.1), reported Anupam B. Jena, MD, PhD, of Harvard Medical School in Boston, and co-authors in a research letter in JAMA.
    • “After replacing the previous 10-digit number for suicide and crisis services with the 3-digit number and investing more than $1.5 billion to expand crisis center capacity and workforce nationwide, “988 appears to be working where it matters most, in reducing suicide deaths among the young people who use it the most … saving lives, at scale, within a few years of launch,” said co-author Vishal R. Patel, MD, MPH, also of Harvard Medical School.
    • “Prior evidence for the lifeline was mostly indirect: higher call volumes, positive caller surveys, reductions in same-day distress,” Patel told MedPage Today. In contrast, this study shows that the lifeline actually affects suicide mortality at the population level, he noted.”
  • HR Dive relates,
    • “The U.S. Department of Labor’s Wage and Hour Division on Wednesday announced a proposed rule to streamline joint employer status under the Fair Labor Standards Act, the Family and Medical Leave Act, and the Migrant and Seasonal Agricultural Worker Protection Act, according to a department press release.
    • “The rule would create “a single nationwide standard that both derives from commonalities in federal court precedent where available and resolves significant differences among the circuit courts where they exist,” DOL said, to “ensure employees and employers have a clear, consistent understanding of when multiple employers are jointly responsible for protecting the wages and other rights of an employee.”

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • ‘Merck is carving out its own place in the evolving HIV treatment space with an FDA approval for its Idvynso, a combination regimen that brings its novel islatravir to market for the first time and serves as the cornerstone of what could be a lucrative HIV franchise for the company. 
    • “Idvynso is a once-daily, two-drug oral pairing of Merck’s doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has been commercialized since 2018 as part of Merck’s Pifeltro and Delstrigo, while islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI) that represents the “anchor medicine” in a number of other HIV combos that the company is advancing.
    • “The doravirine and islatravir combo’s debut is specifically targeted at patients who are switching from other HIV treatments and will be available in pharmacies after May 11, Merck said in its April 21 press release.” 
  • STAT News relates,
    • “The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  
    • “Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.
    • “While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  
    • “Roche has touted the potential of fenebrutinib — an oral tablet — noting that it hit its efficacy mark across different types of MS and offers a new approach for treating the disease. It’s also sought to differentiate its therapy from Sanofi’s rejected drug, called tolebrutinib.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Revolution Medicines’ closely watched pancreatic cancer drug helped control tumors when administered early in a patient’s disease course, stimulating a response in at least half of those who got it either as a single treatment or alongside chemotherapy, according to trial results unveiled at a medical meeting Tuesday.
    • “The findings disclosed at the American Association for Cancer Research’s annual convention come from studies testing the therapy, daraxonrasib, in first-line pancreatic cancer. They follow, by a week, Phase 3 data showing the drug nearly doubled survival in people whose disease had progressed after an earlier treatment, sparking a share surge that has launched the company’s valuation past $30 billion.
    • “The Food and Drug Administration gave Revolution a special regulatory fast-pass that could lead to a clearance within weeks of an approval submission.”
  • and
    • “A three-drug combination involving Merck & Co.’s Welireg failed to significantly delay tumor progression or extend survival in a Phase 3 trial of patients newly diagnosed with the most common form of kidney cancer, setting back the big drugmaker’s plans to further expand use of the medication.
    • “The study evaluated Welireg alongside Merck’s immunotherapy Keytruda and Eisai’s Lenvima in first-line clear cell renal cell carcinoma and compared that regimen to the Keytruda-Lenvima tandem alone. Merck didn’t provide specifics but said that drug trio — as well as a separate one also tested in the trial — missed the study’s dual main objectives at an interim analysis.
    • “Merck noted how the findings don’t affect other ongoing studies in “Litespark,” the broad program it’s jointly conducting with Eisai and that includes other Welireg tests. The Food and Drug Administration is reviewing an application based on results from one Litespark study that would expand use of Welireg earlier in kidney cancer.”
  • MedPage Today relates,
    • “In a survey of roughly 45,000 U.S. adults representing more than 257 million people, 9% said they had obesity and drank heavily over the past month, while 3.8% said they had both obesity and met criteria for alcohol use disorder (AUD) over the past year, reported researchers led by Bryant Shuey, MD, MPH, of the University of Pittsburgh.
    • “Overlapping heavy drinking and obesity was most common among men ages 35 to 49 (13.6%), women ages 26 to 34 (11.9%), and Black individuals (11.9%). AUD and obesity overlap was highest for men and women ages 26 to 34 (6.2% and 5.1%), people without insurance, and those on Medicaid, the findings in JAMA Internal Medicine showed.
    • “Shuey and colleagues said the findings on this high-risk population call for public health and clinical interventions tailored to younger and middle-age adults, especially the uninsured and those on Medicaid, to prevent liver disease and liver-associated deaths.” * * *
    • “Given the effectiveness of GLP-1 drugs “for weight loss and metabolic dysfunction–associated steatohepatitis, expanding access for patients with co-occurring risky alcohol use and obesity may reduce liver disease burden,” they argued.”
  • Health Day tells us,
    • “Pregnancy-related deaths in the U.S. increased sharply during the COVID-19 pandemic, particularly among Black women, a new study reports.
    • “Deaths remain significantly higher today for Black mothers, even though they’ve returned to pre-pandemic levels for most other groups, researchers reported in the journal Obstetrics & Gynecology.
    • “We saw a dramatic increase in pregnancy-related deaths during the COVID-19 pandemic, but the recovery has not been equal across all groups,” said senior researcher Dr. Lindsay Admon, an associate professor of obstetrics and gynecology at the University of Michigan Medical School.
    • “We need to better understand what’s driving these differences so we can develop solutions that reduce maternal deaths and improve outcomes for everyone,” she said in a news release.”
    • * * * “Results showed that maternal deaths during or just after pregnancy rose more than 60% during the pandemic, from about 20 deaths per 100,000 live births in 2019 to 33 per 100,000 in 2021.
    • “Most of the pandemic increase was linked to COVID-associated deaths, researchers found. Early pregnancy death rates rose by 7.5 per 100,000 live births, and later pregnancy deaths by 3.7 per 100,000.
    • “By 2023 and 2024, early pregnancy deaths had returned to pre-pandemic levels, but those late in pregnancy and after pregnancy remained elevated.
    • “All death rates remained notably higher for Black mothers, researchers found.”
  • Per an NIH news release,
    • “In a National Institutes of Health (NIH)-funded study, researchers developed a cancer assessment tool that can identify high-risk patients and the tumor cells linked to that risk. The model, called scSurvival, uses a machine learning framework designed to analyze large-scale data at single-cell resolution. 
    • “With NIH support, Oregon Health & Science University (OHSU) tested the model on clinical data from more than 150 cancer patients. The tool predicted survival outcomes and linked specific cell populations to higher risk. 
    • “A risk assessment tool that not only tells you who may be at higher risk, but also provides clues as to why, could really help in these difficult cancers” said Anthony  Letai, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI).”  

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

  • Beckers Hospital Review relates,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $281 million (9.5% margin) on revenues of $3 billion in the first quarter of 2026, down slightly from a $284 million operating gain (9% margin) in the same period last year. 
    • “However, after interest payments on debt and other expenses, CHS reported a net loss of $58 million in the first quarter, compared to a $13 million loss in the first quarter of 2025. 
    • “We are pleased with the continued, tangible progress on our key priorities, demonstrated by improvements in quality scores, patient experience and physician satisfaction measures, and investments in growth opportunities,” CEO Kevin Hammons said in an April 21 news release. “In the face of a dynamic macroeconomic environment, we remain focused on the variables within our control and believe we are positioning the company for long-term success and value creation.”
  • and
    • “Optum Rx — the pharmacy benefit manager for UnitedHealth Group — claims its “PreCheck” prior authorization tool not only cuts prescription approval times but also reduces denials and appeals.
    • “UnitedHealth Group gave an update on the tool in an April 21 earnings call. Optum CEO Patrick Conway, MD, said denials due to missing information dropped by 68% and appeals were down 88%, thanks to PreCheck. He said PreCheck has been “easing interactions for clients, members and providers.”
    • “Dr. Conway reaffirmed that PreCheck has axed prescription approval time from eight hours to fewer than 30 seconds. 
    • “Optum Rx announced an expansion of PreCheck in November, alongside its decision to eliminate reauthorization requirements for 40 medications. In the November release, UnitedHealth Group said, as of this year, the PreCheck platform covers more than 45 medications and is leveraged across 20 health systems.”
  • Healthcare Dive tells us,
    • “Amazon is launching a weight management program with access to GLP-1s through its One Medical primary care chain, in a bid to help consumers more easily access the popular weight loss drugs alongside supportive care, the retail and technology giant said Tuesday. 
    • “Under the program, users work with a dedicated provider to receive a GLP-1 medication as well as follow-up care, so patients can adjust their treatment and address related health concerns like cardiovascular disease and diabetes. 
    • “Patients can also access prescriptions for “transparent pricing” on Amazon Pharmacy, the company said. New GLP-1 pills start at $25 per month with insurance or through cash-pay options as low as $149 per month.”
  • Fierce Pharma informs us,
    • “As pharma giants slash headcounts and routinely strike billion-dollar M&A deals, another trend is steadily playing out at many of the largest drugmakers: adoption of AI on a corporate scale.
    • “Mark Merck as a participant in this movement. On Wednesday, the company revealed a partnership with Google Cloud as it works to undergo an “agentic AI enterprise transformation.”
    • “As part of an investment in Google Cloud valued at up to $1 billion, Merck will get access to the tech giant’s agentic AI platform across its R&D operations, manufacturing, commercial teams and corporate functions.
    • “Notably, the deal involves Google Cloud engineers working directly with Merck’s teams to onboard the tech, according to the April 22 press release. In a statement, Dave Williams, Merck’s chief information and digital officer, noted that the AI push comes “as we enter one of the most significant launch periods in our company’s history.”
  • Beckers Health IT adds,
    • “UnitedHealth Group is betting big on AI in 2026 — $1.5 billion to be exact. 
    • “During the company’s Q1 earnings call, leaders fleshed out how that investment is materializing.
    • “Think about it this way: A third of this is explicitly invested into software products and platforms, accelerating Optum Insight’s transition of business models into an AI-first software and services firm. The remaining two-thirds is spent across signature end-to-end processes and functions across UnitedHealth Group,” Optum Insight CEO Sandeep Dadlani said. 
    • “Optum Insight, the technology-enabled services business under UnitedHealth, will manage internal AI use cases, which could eventually be translated and commercialized beyond the company. UnitedHealth expects a 2-to-1 return, much of it within the next 12 to 18 months.”
  • and
    • “Michael and Susan Dell have surpassed $1 billion in total giving to the University of Texas at Austin, becoming the university’s first billion-dollar donors, according to an April 21 news release.
    • “The latest investment will support development of the UT Dell Campus for Advanced Research, anchored by an AI-focused UT Dell Medical Center expected to open in 2030. The Dells’ investment will also support expanded supercomputing capabilities, student scholarships and housing.
    • “The medical center will integrate Houston-based University of Texas MD Anderson Cancer Center to provide cancer care as part of the new campus.
    • “The university plans to break ground on the medical center later in 2026.”
  • Fierce Pharma points out,
    • “After AbbVie earlier this year pledged a whopping $100 billion in U.S. R&D and capital investments over the next decade, the company is filling in more details on its expansion plans. And like with many other pharma giants, it’s putting down roots in North Carolina.
    • “The North Chicago-based drugmaker on Wednesday revealed its largest-ever capital investment in a single campus, plotting a 185-acre production hub in Durham. The project will cost some $1.4 billion and add more than 730 roles to the company’s headcount, according to an April 22 press release. The site will produce certain AbbVie medicines in its immunology, neuroscience and oncology portfolios.”

Tuesday report

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports,
    • “The Medicare agency will extend a short-term program that will pay for weight-loss drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s NOVO.B -4.19%decrease; red down pointing triangle Wegovy, guaranteeing access to the popular medications will continue for seniors next year. 
    • “The decision by the Centers for Medicare and Medicaid Services comes after big Medicare insurers signaled that they didn’t initially plan to join a separate, longer-term payment model for the drugs that was supposed to launch at the start of 2027, throwing its future into question.
    • “Instead, the interim Medicare program, which starts in July and was expected to run only until the end of 2026, will continue until the end of 2027. Under this program, the government effectively pays for the medications, rather than adding them to Medicare insurers’ drug plans, which forces the insurers to account for the cost. 
    • “A CMS spokeswoman said the agency was extending the short-term program “after listening to stakeholder feedback.” The change will “allow data collection that will support a more effective potential implementation” of the longer-term model.
    • “The decision is good news for manufacturers such as Lilly and Novo Nordisk, which are counting on Medicare coverage to boost sales of their weight-loss drugs. Previously, Medicare Part D plans have been barred from covering weight-loss drugs, which means seniors who want to take them have had to pay several hundred dollars a month out of pocket.”
  • The House Appropriations Committee did not complete voting on the Financial Services and General Government (FSGG) bill today, having taken up and passed a Military Construction and Veterans Affair bill as the first order of business. The Committee will resume considering the FSGG bill tomorrow morning at 10 am ET.
  • The American Hospital Association News lets us know,
    • “Secretary of Health and Human Services Robert F. Kennedy Jr. April 21 testified in two hearings on the proposed fiscal year 2027 HHS budget, which requests $111.1 billion. In the morning, Kennedy testified before the Energy and Commerce Committee Health Subcommittee, and in the afternoon, he appeared before the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. He testified last week in a pair of meetings, one at the House Ways and Means Committee and another at the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.
    • ‘While the budget request is not binding, it serves as a preliminary framework for Congress and the administration as they determine federal funding levels and the scope of health care policy this year.”
  • STAT News relates
    • “The Trump administration will ask states to create new plans to verify medical providers paid by federally funded health care programs as part of a broad effort to combat fraud in government programs, Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, said Tuesday.
    • “The administration will ask states to develop plans in the next month to revalidate providers in “high-risk” areas to determine whether they exist and have the right to provide services, Oz said at Politico’s health care summit.
    • “The announcement is another step from the administration in its aggressive — and highly publicized — attacks on alleged waste, fraud, and abuse in federal health care programs. The administration has targeted certain programs and providers primarily in Democrat-led states such as Minnesota and California, though the administration’s claims have been disputed at times by state leaders. 
    • “We’re asking the states to own that problem,” Oz said.
    • “States that don’t take the effort seriously, he said, could become targets of closer federal scrutiny.”
  • The Government Accountability Office (GAO) adds,
    • “GAO has designated Medicare a high-risk program due, in part, to its complexity and potential for fraud. Fraud schemes in traditional Medicare often focus on certain services, such as durable medical equipment. Fraudsters may use stolen or inappropriately obtained Medicare beneficiary identifiers to submit fraudulent claims for unneeded or never provided services.
    • The Centers for Medicare & Medicaid Services (CMS), which oversees Medicare, uses data analytics on claims in traditional Medicare to identify anomalous patterns indicative of emerging fraud schemes and potentially fraudulent behaviors, such as billing spikes. CMS uses these analytics to develop leads for investigations and to inform administrative actions that can prevent potentially fraudulent payments, such as suspending provider payments. For example, in 2023 and 2024, CMS suspended payments to, and later revoked the enrollment of, 15 providers involved in a scheme that allegedly billed Medicare for more than $4 billion in urinary catheters that were never supplied. Selected private payers GAO spoke with reported using data analytics in ways similar to CMS—namely, to identify anomalous provider billing patterns to generate leads for investigations and to inform actions like payment suspensions.
    • CMS estimates that from fiscal years 2022 through 2024, it prevented a total of $11.9 billion in potentially fraudulent Medicare payments by taking administrative actions on providers engaged in potential fraud.
    • Here is a link to the GAO report.
  • The American Journal of Managed Care tells us
    • “Cancers with the highest lethality receive disproportionately lower levels of federal research support, according to a research letter published today in JAMA Network Open.
    • “Outcome-weighted metrics (mortality, 5-year survival, MIR) better capture unmet need than incidence alone when assessing cancer burden and urgency. 
    • “Lung cancers accounted for 151,401 deaths, exceeding pancreatic (49,211), breast (22,606), and prostate (5,219) among the cancers evaluated. 
    • “Mortality-to-incidence ratios highlighted extreme lethality in SCLC and pancreatic cancer (>0.85), while breast and prostate cancers showed low ratios (<0.10) consistent with higher survivorship. 
    • “Funding per estimated death was markedly higher for breast ($69,800) and prostate ($126,992) than pancreatic ($8,945) and SCLC ($2,818), supporting a composite allocation framework.”

From the Food and Drug Administration front,

  • Radiology Business informs us,
    • “Conavi Medical, a Toronto based medtech company, received U.S. Food and Drug Administration (FDA) clearance for a next-generation hybrid imaging system capable of performing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at the same time. 
    • “Conavi has carved out its own space in the field of intravascular imaging by developing hybrid systems that save cath labs valuable space by performing two different exams of a patient’s coronary anatomy at once. The company’s original Novasight Hybrid System gained FDA clearance in 2018.” * * *
    • “Conavi hopes to start commercializing this next-generation technology and initiate a limited market release in the second half of 2026.”

From the judicial front,

  • STAT News reports,
    • “A judge is expected to sentence OxyContin maker Purdue Pharma to forfeit $225 million to the Justice Department on Tuesday, clearing the way for the company to finalize a settlement of thousands of lawsuits it faces over its role in the opioid crisis.
    • “The penalty was agreed to in a 2020 pact to resolve federal civil and criminal probes it was facing. If the judge signs off, other penalties will not be collected in return for Purdue settling the other lawsuits.
    • “After years of legal twists and turns, the settlement was approved by another judge last year and could take effect May 1. It requires members of the Sackler family who own the company to pay up to $7 billion to state, local and Native American tribal governments, some individual victims and others.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A mobile health intervention helped pregnant patients with overweight or obesity reduce gestational weight gain (GWG), a cluster-randomized trial showed.
    • “The weekly rate of GWG was significantly lower in the intervention group versus the standard care group (mean 0.25 vs 0.28 kg/week; mean between-group difference -0.03, 95% CI -0.05 to -0.01), reported Monique M. Hedderson, PhD, of Kaiser Permanente Northern California in Pleasanton, and colleagues.
    • “Total GWG was also significantly lower in the intervention group, at a mean of 9.7 kg compared with 10.6 kg in the standard care group (mean between-group difference -0.87, 95% CI -1.40 to -0.34), they wrote in JAMA Network Open.” * * *
    • “The Lifestyle, Eating, and Activity in Pregnancy (LEAP) intervention utilizes a smartphone app, wireless scale, and activity tracker to promote healthy eating and increased activity. As a stepped intervention, more intensity is reserved for those on track to gain more weight. All participants are given a personalized calorie target and weekly education topics, and are encouraged to track weight, activity, and diet. Step two adds two weekly personalized chat messages with a lifestyle coach/registered dietitian and step three adds biweekly telephone sessions.
    • “LEAP shows “that combining clinician engagement with patient‑facing digital tools can improve gestational weight outcomes in real‑world care settings,” Hedderson said.”
  • Medscape points out,
    • “The American College of Physicians (ACP) has updated its guidance on screening for breast cancer in asymptomatic average-risk women using recent high-quality clinical recommendations from guideline developers from expert societies around the world.
    • “Publishing in the Annals of Internal Medicine, panelists led by Amir Qaseem, MD, PhD, MHA, the ACP’s chief scientific officer and senior vice president of clinical policy, made five recommendations, taking into account age group and breast density category.
    • “This updated guidance statement is based on new data and new or updated guidelines evaluated by the ACP since the publication of our 2019 guidance statement, which is over 7 years old,” Qaseem told Medscape Medical News.”
  • The American Medical Association lets us know what doctors wish their patient knew about appendicitis.
    • “There’s a pain in your abdomen. Is it something as simple as gas or is it appendicitis? Four physicians share what to keep in mind about appendicitis.”
  • Health Day informs us,
    • “The overdose-reversing drug naloxonehas been rightly hailed as a lifesaving breakthrough, saving countless lives from opioid ODs.
    • “But a new study warns that the wonder drug has its limits, especially when confronted with overdoses involving the powerful new wave of synthetic opioids like fentanyl.
    • “Naloxone may not fully reverse ODs caused by synthetic opioids, researchers report in the May issue of the journal Anesthesiology.
    • “As a result, bystanders should be ready to give additional doses of naloxone if the first doesn’t restore an overdose victim’s breathing, researchers said.”
  • Genetic Engineering and Biotechnology News relates,
    • “Researchers from Kindai University in Japan have developed a machine learning model that accurately predicts the origin of diverse cancer types in patients with cancers of unknown primary (CUP) by analyzing CpG-based DNA methylation. Results showed that the model correctly identified the cancer type in about 95% of cases in the test cohort and achieved 87% accuracy when applied to an independent validation cohort from 31 cases representing 17 different cancer types. The work was presented at the American Association for Cancer Research (AACR) Annual Meeting.  
    • “Our findings suggest that DNA-based approaches can help identify where a cancer may have started, even when the original tumor is not visible,” said Marco A. De Velasco, PhD, a faculty member in the department of genome biology at Kindai University in Japan.”  
  • STAT News notes,
    • “BioAge Labs said Tuesday that its investigational pill for cardiovascular risk prevention significantly reduced inflammation in an early study, as more drug companies target inflammation as a way to treat a range of chronic conditions.
    • “In a Phase 1 study of people with obesity and elevated inflammation levels, patients taking a 60-milligram dose of the drug, called BGE-102, experienced an 85% reduction in a measure of inflammation called high-sensitivity C-reactive protein (hs-CRP) after one week, and the reduction was maintained three weeks out. That’s a similar effect seen in patients who took a higher 120-mg dose in the study, which the company previously reported.”
    • “Additionally, 87% of patients taking the 60-mg dose achieved hs-CRP levels of less than 2 mg/liter, the threshold thought to be associated with a lower risk of cardiovascular complications.
    • “High cholesterol and blood pressure have long been known contributors to heart disease, but researchers more recently identified inflammation as a risk factor as well. Companies like BioAge are betting that drugs that can effectively reduce inflammation could one day be as widely used as statins.” 

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • :UnitedHealth Group UNH reported first-quarter results that substantially overshot Wall Street expectations and raised its annual guidance, signaling progress in its financial turnaround.
    • The announcement is likely to build investor confidence in the healthcare company’s current direction, a year after UnitedHealth announced an earnings shortfall that touched off an unprecedented share meltdown for the company.
    • “Former Chief Executive Stephen Hemsley returned to the top job last May, saying the company needed a reset. He has focused on retrenching and bolstering margins.” * * * 
    • “UnitedHealth highlighted changes made under Hemsley’s tenure, including replacing almost half the company’s top 100 executives and making substantial artificial-intelligence investments. UnitedHealth said it had struck a deal to take over Alegeus Technologies, a benefits-administration company, without disclosing the financial terms.”  
  • BioPharma Dive relates,
    • “Flagship Pioneering has launched a new biotechnology firm that believes it’s found a way to solve the problems that have long held back genetic medicine. 
    • “Called Serif Biomedicines, the startup officially debuted on Tuesday armed with $50 million in funding and the ability to make what it refers to as “modified DNA” medicines.
    • “According to CEO and co-founder Jacob Rubens, Serif’s drugs are designed to combine the strengths of multiple types of genetic medicines, from gene therapy to the messenger RNA and small-interfering RNA approaches popularized by companies like Moderna and Alnylam Pharmaceuticals. Its treatments consist of two components: finely tuned instructions for a therapeutic protein as well as an mRNA sequence for “co-factors” that can help the treatment get into a cell’s nucleus. They’re sent to cells with the help of fatty shells called lipid nanoparticles, which are commonly used to deliver complex medicines.”
  • Adam Fein writes in his Drug Channels blog,
    • “Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs. 
    • “For 2025, DCI has identified more than 1,900 dispensing locations with specialty pharmacy accreditation from one or both of the two major independent accreditation organizations. The overall number of accredited locations grew by only 3% in 2025, but is more than five times larger than the 2015 figure.
    • “However, market share for the dispensing of specialty drugs remains highly concentrated. For 2025, the three largest specialty pharmacies accounted for two-thirds of total prescription revenues from pharmacy-dispensed specialty drugs. These businesses are all owned by vertically integrated organizations that also own a PBM.”
  • Beckers Hospital Review informs us,
    • “More Wegovy prescriptions are being written as GLP-1 weight loss drugs gain traction across retail, telehealth and direct-to-consumer channels, according to an April 20 report from Truveta Research.
    • “The growth follows the FDA’s December approval of oral Wegovy (semaglutide) and other GLP-1 pills. Diverging commercialization strategies from manufacturers are also reshaping how patients access these therapies and how health systems approach formularies and metabolic care programs.”

Monday report

David Ermer–CMS, Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Tomorrow at 11 am ET, the House Appropriations Committee will consider its subcommittee’s print of the appropriations bill for financial services and general government, including the Office of Personnel Management for the fiscal year ending September 30, 2027.
  • The subcommittee’s print includes the standard appropriations provisions exempting FEHB and PSHB carriers from full Cost Accounting Standards coverage (Sec. 611) and limiting abortion coverage to cases when carrying the fetus to term would endanger the mother’s life or the pregnancy results from rape or incest (the Hyde amendment, Secs. 613, 614). The bill (Sec. 761) also states “None of the funds made available by this Act, or in any previous appropriation, may be provided for in insurance plans in the Federal Employees Health Benefits program to cover the cost of surgical procedures or puberty blockers or hormone therapy for the purpose of gender affirming care.” The bill no longer includes the contraception mandate that OPM treated as overridden by the ACA’s contraception mandate. 
  • Federal News Network reports,
    • “The Office of Personnel Management and the General Services Administration — the federal government’s human resources office and landlord, respectively — are embarking on plans to move under one roof.
    • “GSA will temporarily relocate to OPM’s headquarters, the Theodore Roosevelt Federal Building, starting in July, while GSA’s 1800 F St. headquarters goes through a renovation.
    • “In December 2028, GSA will move back into its renovated headquarters, along with OPM. Once consolidation is complete, GSA says it will initiate an “accelerated disposal” of OPM’s old headquarters building.” * * *
      “The first Trump administration proposed merging OPM and GSA into a single agency, but ultimately walked away from those plans. In addition to managing a governmentwide real estate portfolio, GSA provides contracting and IT support to other federal agencies.
    • “OPM Director Scott Kupor said there are no talks of a possible merger of the two agencies.”
  • and
    • “House and Senate Democrats are urging the Office of Personnel Management to halt its plans for collecting detailed medical data on potentially millions of enrollees in the government’s health insurance programs.
    • “Citing “significant legal, ethical and security concerns,” two recent letters sent to Trump administration officials identified potential legal violations and the possibility of targeting enrollees across the Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs.
    • “The collection of broad, personally identifiable data regarding medical care and treatment raises concerns that OPM could target certain federal employees seeking vital health care services that the administration disagrees with on political grounds,” House Democrats on the Oversight and Government Reform Committee wrote in an April 17 letter, addressed to OPM and the Office of Management and Budget.
    • “This proposal is another step in the stated goal of traumatizing the federal workforce,” Senate Democrats, led by Sens. Adam Schiff (D-Calif.) and Mark Warner (D-Va.), wrote in a separate April 19 letter to OPM Director Scott Kupor. “We are deeply concerned this information will be used in employment actions, including actions related to hiring, suitability determinations, appeals, reductions in force, disability accommodation requests, labor-management relations and performance reviews.”
  • Roll Call adds,
    • “Senate Republicans plan to release their budget resolution and take a procedural vote as early as Tuesday, kicking off the cumbersome process for a reconciliation bill designed to help end the partial shutdown of the Department of Homeland Security.
    • “Senate Majority Leader John Thune, R.S.D., said Monday he hopes to confine the bill to the narrow mission of funding Immigration and Customs Enforcement and the Border Patrol. “
  • HR DIve relates,
    • “Secretary of Labor Lori Chavez-DeRemer resigned on Monday, she confirmed in a post to her official X account, ending her tenure after just over one full year leading the U.S. Department of Labor.
    • “Chavez-DeRemer’s departure followed recent reports that the agency’s inspector general had launched an investigation into her potential misconduct, including contact between her family and department staff. Similar previous inquiries reportedly led to the departure of employees including Chavez-DeRemer’s chief of staff and deputy chief of staff.
    • “Chavez-DeRemer said in her post Monday that under her watch, DOL “created new pathways to mortgage-paying jobs, prepared workers to excel in the age of AI, took steps to lower prescription drug costs, promoted retirement security, and so much more.” A White House spokesperson did not immediately respond to a request for comment.”
  • The American Hospital Association News tells us
    • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat down with Bill Gassen, president and CEO of Sanford Health and AHA chair-elect, for a discussion about the changes that have occurred in CMS in the past year, as well as how they intend to move forward.  
    • Oz described the agency’s focus this year on working with insurers to reduce the need for prior authorizations. In addition, both Oz and Brillman spoke on the agency’s drive to reduce unnecessary spending; Oz estimated that 5% of CMS’ budget, or about $100 billion, is lost to fraud, waste and abuse.  
    • “Brillman spoke on the new community engagement standards that require most Medicaid recipients to perform a certain number of employment or volunteer hours to maintain their eligibility for benefits, which Brillman said provides “paths to prosperity” for beneficiaries, saying, “if we get someone a higher income so they no longer need services, that’s a win for all Americans.” 
    • “Technology, especially the use of artificial intelligence, was also acknowledged as an important advancement, with Oz saying that current technology offers “a generational opportunity to fix health care,” noting that “I do not see a way to make health care as great as it could be without AI.”  
    • “Oz spoke on last year’s Rural Health Transformation Fund, saying that the infusion of $50 billion over five years will have nationwide effects. “The learnings will accrue to urban centers,” he said. “[The fund] is creating a sandbox in rural areas, and what you learn will benefit all of you.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Reaching for the salt shaker could have long-lasting implications for your memory and brain health, a new study says.
    • “Higher sodium intake appears to affect episodic memory, the type of memory used to recall personal experiences and specific events from your past, researchers report in the June issue of the journal Neurobiology of Aging.
    • “This effect – which could cause one to forget anything from where they parked the car to their first day of school – occurred mainly among men, researchers found.
    • “No such associations were observed among women in the study, researchers said.”
  • The American Medical Association lets us know seven things patients should know about protein maxxing.
  • Healio relates,
    • “Prescriptions for direct-acting antivirals to treat hepatitis C virus in the U.S. have declined substantially since 2015 and remain well below the approximately 260,000 annual treatment courses needed to meet the target for elimination.
    • “Results of a national cross-sectional analysis showed annual treatment volume trending alongside HCV infection rate, rather than surpassing it.
    • “We’re roughly treating the same number of people each year as there are new infections,” Sanjay Kishore, MD, assistant professor at University of Virginia School of Medicine, told Healio. “We’re essentially just holding steady and not actually making any progress.” * * *
    • “I think we need to think creatively about using things like mobile clinics to take care of people. We need to really lean into telehealth on this issue, and we need to expand screening to places where people are getting addiction treatment. Maybe instead of a hospital, it’s a rehab facility or a syringe exchange. We need to make it easier to connect with clinicians and get treatment to meet people where they are.”
  • MedPage Today tells us,
    • “Adults whose type 2 diabetes was treated with GLP-1 receptor agonists were more than likely to develop cognitive impairment over 10 years than their counterparts not treated with GLP-1 agents, a propensity-matched retrospective study of nearly 65,000 patients suggested.”
  • and
    • “Lower hemoglobin levels were linked with higher dementia risk over 9 years of follow-up.
    • “Anemia was associated with elevated Alzheimer’s blood biomarkers including p-tau217 and neurofilament light chain.
    • “Dementia risk was highest when anemia coexisted with abnormal Alzheimer’s biomarkers.”
  • BioPharma Dive offers news from the annual meeting of the American Association for Cancer Research and informs us,
    • “An experimental autoimmune drug from Nektar Therapeutics helped people with alopecia areata who’d already responded to the treatment in a Phase 2 trial grow more hair as time went on, the company said Monday.
    • “The data released Monday measured hair regrowth after 52 weeks of treatment with the therapy, known as rezpegaldesleukin. Nektar disclosed last year that the therapy failed to show a statistically significant benefit over a placebo after 36 weeks. The company, though, blamed that result on the inclusion of four patients that shouldn’t have been eligible and said the findings supported additional development.”
  • Fierce Pharma points out,
    • “Sanofi’s protein-based vaccine Nuvaxovid has conquered Moderna’s next-generation messenger RNA shot mNexspike in a head-to-head trial assessing the tolerability of the two COVID vaccines.
    • “In the phase 4 double-blind, real-world study, which included 1,000 adult participants in the United States, Nuvaxovid showed statistically significant fewer side effects across all pre-specified endpoints.
    • “Symptomatic reactions with Nuvaxovid were both milder and shorter than with mNexspike. Additionally, less than 10% of those who received Nuvaxovid experienced severe side effects—such as fatigue, headache or fever which prevented them from conducting their daily activities—compared to 20% of those who got mNexspike. As for injection site symptoms such as pain, redness and swelling, they were more than 75% more frequent for those who received Moderna’s shot.”

From the U.S. healthcare business front,

  • ‘Per a Lockton news release,
    • “Lockton’s eighth annual survey of over 1,700 U.S. employers helps employers compare their benefit strategies with those of other employers -providing benchmark data, highlighting trends, and illuminating new ideas.
    • “As healthcare costs rise and economic pressures mount, cost is a defining reality for employers. The 2026 Lockton National Benefits Survey shows a rapid acceleration of a shift that first took hold last year – cost management decidedly the top priority vs the next ranked priority – attracting and retaining talent. The data shows how employers are searching for an answer to their need for cost containment solutions.
    • “To gain further insights into the 2026 survey findings, you can access the executive summary here.”
  • The Peterson / KFF Health System Trackers identifies recent trends in employer-based health coverage.
    • “Key takeaways include:
      • “In March 2025, 60.0% of the non-elderly, or about 165.6 million people, had employer sponsored insurance or ESI. 
      • “About four in five (80.4%) adult non-elderly workers worked for an employer that offered ESI to at least some employees, a share that has been consistent over recent years. 
      • “The share of workers eligible for ESI at their job declined slightly over the past few years, from 75.3% in March 2023 to 74.6% in March 2025. 
      • “Most eligible workers who do not take up ESI offered at work cite other coverage (63.0%) and cost (30.2%) as the reason.”  
  • Beckers Hospital Review tells us,
    • “As more care shifts outside hospital walls, health system leaders are rethinking how they plan, staff and structure their workforces to support a rapidly expanding ambulatory footprint.
    • “Outpatient services accounted for 57% of hospital revenues in 2024, up from 52% in 2020, according to the American Hospital Association. The AHA’s Sg2 forecasting model projects outpatient volumes will grow another 17% over the next decade. At the same time, many health systems are accelerating ambulatory investments in 2026 to support financial sustainability and expand access closer to home.”
  • MedCity News notes that “Expanding the CJR Model Is a Logical Step in Value Based Care, but Implementation Challenges Remain.”
    • “CMS is proposing to make its joint replacement bundled payment model mandatory nationwide. Experts say it is a logical step, but warn that mandatory participation could be challenging for hospitals to implement.”
  • Healthcare Dive relates,
    • “Physician burnout continues to decline across the U.S., a bright spot for an occupation plagued by heavy workloads, pervasive stress and high stakes. But the improvement is not equal across medical specialties, according to new data from the American Medical Association.
    • “The AMA surveyed thousands of physicians and found that 41.9% reported experiencing a burnout symptom in 2025, down from 43.2% in 2024 and 48.2% in 2023. The decline likely reflects employer efforts to reduce burnout, including by increasing job satisfaction, the medical association said.
    • “However, burnout rates vary significantly across specialties, and tend to be higher among doctors employed by hospitals, suggesting health systems could be doing more to ameliorate the phenomenon.”
  • Fierce Healthcare informs us,
    • “UnitedHealthcare is building on its work to support rural hospitals and will now exempt these facilities from most prior authorizations.
    • “The insurance giant said in an announcement on Monday that the shift will apply across all lines of business. In addition, UHC will accelerate payments by up to 50% for about 1,500 rural hospitals and all critical access hospitals across the country.”
  • and
    • “Just over two years ago, Highmark joined forces with Spring Health to launch a new mental well-being platform that made it far easier for members to access critical services.
    • “Now, the partners are offering a look at how that program has worked for members. In a paper published last month, researchers at Highmark reported that patients waited less than two days on average in 2025 to access an appointment.
    • “Spring’s platform is embedded directly into Highmark’s member app, and that integration was a key part of what made the program work, according to the analysis. Members can easily find mental well-being tools and complete a self-assessment upon connecting for the first time, which allows Spring to build a personalized approach.”
  • The Wall Street Journal points out,
    • “Eli Lilly struck a deal to acquire Kelonia Therapeutics for $3.25 billion upfront and up to $7 billion if certain milestones are reached. 
    • “Kelonia is developing a next-generation CAR-T therapy for multiple myeloma, which promises to transform treatment without chemotherapy.
    • “The acquisition positions Eli Lilly to enter a lucrative segment of the global cancer-drug market and bolster its cancer offerings.”
  • MedTech Dive adds,
    • “Medtronic said Monday it has closed the acquisition of CathWorks, a deal worth $585 million with potential undisclosed earn-out payments.
    • “The transaction, agreed to in February, continues a strategy of increasing acquisitions to strengthen the company’s leadership in its core businesses, Medtronic said.
    • “CathWorks’ FFRangio system uses artificial intelligence and computational science to assess the entire coronary tree from routine angiograms that image the blood vessels.”

Weekend update

David Ermer–Congress, Medical / Rx research, Mental health care, Rx coverage–

From Washington, DC,

  • Roll Call previews this weeks activities on Capitol Hill.
    • “The House Appropriations Committee begins its markup of both the Military Construction-VA and Financial Services spending bills on Tuesday, with subcommittee consideration of the National-Security State and Agriculture bills scheduled for Thursday.
    • “Senate appropriators have a full slate of hearings on Tuesday and Wednesday, with Health and Human Services Secretary Robert F. Kennedy Jr. slated to appear before the Labor-HHS-Education Appropriations Subcommittee on Tuesday.
    • “A bunch of other Cabinet members will follow at their respective subcommittees on Wednesday, including Treasury Secretary Scott Bessent.”
  • The New York Times reports,
    • “President Trump on Saturday signed an executive order seeking to hasten research into the therapeutic benefits of LSD, Ecstasy, psilocybin and other mind-altering drugs by ordering federal agencies to ease restrictions that have long limited the ability of scientists to study them.
    • “The measure also provides $50 million for state-level research into ibogaine, a powerful psychedelic made from the root of a Central African shrub that has been drawing interest from researchers for its potential to treat opioid use disorder and other forms of substance abuse.
    • “The funding will most immediately benefit Texas, which has already committed $50 million to studying ibogaine but recently failed to secure matching funds from a private drug developer.
    • “I’m pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Mr. Trump said from the Oval Office, where he was joined by a number of top cabinet officials and the podcaster Joe Rogan.”
  • Here is a link to the White House fact sheet on this executive order.

From the census front,

  • The New York Times informs us,
    • “Fertility in the United States has been declining since the Great Recession, and reached a new low last year, according to federal data released Thursday {april 9], causing some to fear a baby bust.
    • “But it’s not clear that will happen. Instead, there could be a lull, demographers say — a period of very low fertility that could eventually rebound.
    • “That’s because of a drastic shift among American women who are now of childbearing age: They are waiting longer to have babies. They’ve become much less likely to have them in their teens or 20s — and much more likely to in their 30s or 40s.
    • “Demographers have a name for this kind of lull in fertility: a “postponement transition.” It happened in the 1990s in Europe, then rebounded somewhat as the younger women who delayed pregnancy eventually had children. It also happened in the United States in the 1970s, as more women pursued college and careers after the women’s movement. These women didn’t end up having fewer children; they just had them later.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Doctors may be getting closer to having a potent weapon against a genetic driver of lung cancer that has long lacked any targeted treatment options.
    • “Researchers on Sunday presented early results of clinical trials of two experimental drugs targeting a gene called KRAS, one of the most common and challenging drivers of human cancers. Each drug takes aim at a different KRAS mutation that drives lung cancer, which kills more people worldwide each year than any other form of the disease.
    • “KRAS mutations act as an accelerator in cancer cells. Both drugs shrank tumors and slowed disease progression in patients with advanced cancer that had progressed despite standard chemotherapy and immunotherapy, raising hopes that doctors may be homing in on a new option for a form of cancer that has long resisted treatment. 
    • “I’ve never been this hopeful about KRAS mutations,” said Dr. Lei Deng, an oncologist at Fred Hutch Cancer Center in Seattle who wasn’t involved in either study. The research was presented at the American Association for Cancer Research annual meeting.”
  • Healio points out,
    • “Odds for developing Parkinson’s disease increased with newer groundwater and with carbonate aquifers, according to a poster presented at the American Academy of Neurology Annual Meeting. 
    • “Our previous studies have focused a lot on air pollution, but we know from prior research that contaminated drinking water can also impact health,” Brittany Krzyzanowski, PhD, who conducted the study at Barrow Neurological Institute, told Healio.
    • “There’s a wealth of underused data on drinking water sources, like aquifer type and groundwater characteristics, so we took the opportunity to explore how these factors might be linked to Parkinson’s disease,” said Kryzyzanowski, who is now with the Atria Research Institute.”

Froom the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY is in advanced talks to acquire Kelonia Therapeutics for more than $2 billion, according to people familiar with the matter.
    • “A deal could come as soon as Monday, assuming the talks don’t fall apart, the people said. The deal price could also include additional consideration if Kelonia reaches certain milestones, they said.
    • “Privately held Kelonia is developing a next-generation treatment for the blood cancer multiple myeloma. Buying it would position Eli Lilly to boost its position in the lucrative blood-cancer segment of the $240 billion global cancer-drug market.
    • Kelonia has raised just under $60 million to date, with its last public valuation being a little over $100 million as of April 2022, according to data from PitchBook.
    • “Kelonia is developing a next-generation so-called CAR-T therapy. CAR-T therapies deliver genes—or genetically altered cells—to help a patient’s immune system fight the cancer. 
    • “We have something that is truly transformative to the space,” Kelonia Chief Executive Kevin Friedman said in an interview in January at an industry conference.”
  • Fierce Healthcare tells us,
    • “More than 80% of primary care physicians are concerned about financial stability over the next several years, new research from Elation Health found.
    • “The health tech company surveyed 280 PCPs from Jan. 31 to Feb. 23 for its 2026 Primary Care Pulse Survey Report. Fifty-two percent of respondents were fully independent and 48% have some affiliation. 
    • “As financial pressures mount for PCP practices, 64% cite government and commercial payer reimbursement as their top concern. Staffing costs, workforce challenges, technology and IT costs and rising operational costs are also challenges for responding physicians. 
    • “Simultaneously, the report found 68% of respondents are actively developing plans to address concerns—ranging from increasing marketing to adopting new payment models. Sixty-seven percent of respondents plan to implement changes within the next two years while 27% report already implementing membership or cash-pay models and 18% report adopting value-based payment structures.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iranian war front,

  • The New York Times reports on April 16,
    • “The exchange of bombs and missiles in the Middle East between Iran and its foes has been paused for more than a week now. Iran’s hackers, however, have remained active on the digital battlefield.
    • “Iran has continued its cyberspace operations since the cease-fire with the United States began on April 8, according to Western cybersecurity experts and former U.S. intelligence officials. In doing so, Tehran is trying to keep up pressure on the United States and Israel but also positioning itself to mount a bigger retaliation if peace talks do not resume.” * * *
    • “This is a time, more than ever, we should worry about Iran,” said Evan Peña, a co-founder of the cybersecurity firm Armadin. “In cyberwarfare there isn’t really a cease-fire.”
    • “Mr. Peña said that if the cease-fire or negotiations collapsed, Iran would want to be in a strong position to retaliate, potentially by attacking critical infrastructure in the United States. Tehran has done so in the past but generally with limited impact. More than a decade ago, Iranian hackers targeted a small dam in upstate New York, but by happenstance the dam’s sluice-gate controls had been taken offline for maintenance, much to the relief of U.S. investigators at the time.
    • “Iran, Mr. Peña said, is going to be more aggressive and devote more resources to trying to get access to American companies as the war rages on.” * * *
    • “Josh Zweig, the chief executive of Zip Security, which secures small and midsize enterprises, said Iran was specifically looking for less well-defended targets, like municipal-run water and energy facilities.
    • “He also said small firms that make investment decisions for wealthy individuals and families have been targeted.”

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “National Cyber Director Sean Cairncross expects more executive orders coming from the White House as part of implementing the national cybersecurity strategy, he said Wednesday [April 15].
    • “Staffers on Capitol Hill and others in the cyber world have been awaiting the implementation guidance the Trump administration had proclaimed would come to accompany the strategy  published last month.
    • “Asked at a Semafor event about whether that would include executive orders, Cairncross answered, “I think that that’s the case.”
    • “Cairncross touted American ingenuity for producing an artificial intelligence model like Anthropic’s Claude Mythos, rather than it developing under U.S. cyber rivals like China or Russia. He acknowledged reports about the administration holding meetings about the cyber risks and benefits of something like Mythos — “the model right now that everyone’s talking about” — adding that the administration is looking to balance the dangers and positive capabilities of AI in cyberspace.”
  • and
    • “The federal agency tasked with analyzing security vulnerabilities is overwhelmed as it and other authorities struggle to keep pace with a flood of defects that grows every year. The National Institute of Standards and Technology announced Wednesday that it has capitulated to that deluge and narrowed the priorities for its National Vulnerability Database.
    • “NIST said it will only prioritize analysis for CVEs that appear in the Cybersecurity and Infrastructure Security Agency’s known exploited vulnerabilities catalog, software used in the federal government and critical software defined under Executive Order 14028.
    • “The federal agency’s goal with the change is to achieve long-term sustainability and stabilize the NVD program, which has encountered previous challenges, notably a funding lapse in early 2024 that forced NIST to temporarily stop providing key metadata for many vulnerabilities in the database.” * * *
    • “NIST said CVEs that don’t fit its more narrow criteria will still be listed in the NVD, but they won’t be automatically enriched with additional details. 
    • “This will allow us to focus on CVEs with the greatest potential for widespread impact,” the agency said. “While CVEs that do not meet these criteria may have a significant impact on affected systems, they generally do not present the same level of systemic risk as those in the prioritized categories.”
  • Dark Reading adds,
    • [C]ybersecurity teams will need to move to make up for the loss of enrichment data, according to Shane Fry, chief technology officer at RunSafe Security. 
    • “Anthropic’s Mythos highlights why NIST is making this move in the first place,” Fry says. “They have already seen a surge in CVE submissions over the past year and have not been able to keep up. Mythos and other tools for AI-assisted vulnerability will only add to the volume of vulnerabilities disclosed. It’s a problem the industry has been aware of for some time.” 
    • “So without the ability to keep up with the sheer volume of CVEs cyber teams need to pivot, Fry adds. 
    • “The way forward will have to emphasize building defenses into software itself to prevent the exploit of bugs and zero-days even before patches are available or the vulnerability is disclosed,” he advises.” 
  • Federal News Network tells us,
    • “The [U.S.] Office of Personnel Management announced this week that it will be expanding its Tech Force hiring program to include opportunities for agencies to hire cybersecurity specialists. That’s on top of the program’s existing recruitment efforts for software engineers, data scientists and product managers.
    • “The newly added cybersecurity roles will focus on “protecting critical systems, strengthening federal cybersecurity capabilities and safeguarding the digital infrastructure relied on by millions of Americans,” OPM said in a press release.
    • “The federal government depends on strong cybersecurity to protect critical systems and maintain public trust,” OPM Director Scott Kupor said Monday. “Through Tech Force, we’re recruiting highly skilled cybersecurity professionals to take on real challenges and strengthen the government’s defenses where it matters most.”
  • Cyberscoop informs us,
    • “Authorities from 21 countries took down 53 domains and arrested four people allegedly involved in distributed denial-of-service operations used by more than 75,000 cybercriminals, Europol said Thursday. 
    • “The globally coordinated effort dubbed “Operation PowerOFF” disrupted booter services and seized and dismantled infrastructure, including servers and databases, that supported the DDoS-for-hire services, officials said.
    • “Law enforcement agencies obtained data on more than 3 million alleged criminal user accounts from the seized databases, and ultimately sent more than 75,000 emails and letters to participants, warning them to halt their activities.”
  • and
    • “Two New Jersey men were sentenced Wednesday for facilitating North Korea’s long-running scheme to plant operatives inside U.S. businesses as employees, generating more than $5 million in illicit revenue for the regime, the Justice Department said. 
    • “The U.S. nationals — Kejia Wang, also known as Tony Wang, and Zhenxing Wang, also known as Danny Wang — were part of a years-long conspiracy that placed operatives in jobs at more than 100 U.S. companies, including many Fortune 500 companies, based in 27 states and the District of Columbia. * * *
    • “Both men previously pleaded guilty to an assortment of crimes. Kejia Wang was sentenced to nine years in prison for conspiracy to commit wire and mail fraud, money laundering and identity theft. Zhenxing Wang was sentenced to 92 months in prison for conspiracy to commit wire and mail fraud and money laundering. 
    • “The pair were also ordered to forfeit a combined $600,000, of which two-thirds has already been paid, officials said.”

From the cybersecurity breaches and vulnerabilities front,

  • Health Exec reports,
    • “Healthcare IT infrastructure and electronic health record company CareCloud confirmed in a regulatory filing that it’s suffered a data breach, said to have impacted one of its six patient record stores, with hackers inside its network for “approximately eight hours.”
    • “The “cybersecurity incident” was disclosed in a filing with the U.S. Securities and Exchange Commission, and said the incident occurred on March 16. The company said that, while intruders did access patient medical records, it wasn’t clear if any data was stolen.
    • “An investigation into the data breach is still ongoing, and CareCloud said it’s working with a third-party cybersecurity organization to gather the details. After some downtime, CareCloud said it believes the invasion has been thwarted and that criminals no longer have a way inside its network.
    • “Systems were taken down and restored the same day. Details such as how the cyberattack was conducted and if any ransomware was deployed was not revealed. It’s also not clear if any notable cybercrime syndicate was behind the data breach, nor whether those responsible made any demands. 
    • “The filing with the SEC was released on March 24, and there hasn’t been any real update from the company since.”
  • The Cybersecurity and Infrastructure Security Agency added ten known exploited vulnerabilities (KVEs) to its catalog this week.
  • Cybersecurity Dive tells us,
    • “Hackers are attempting to exploit a high-severity flaw found in several end-of-life routers from TP-Link, according to a blog post published Friday [April 17] by Palo Alto Networks’ Unit 42. 
    • “Researchers warn the observed payloads share similarities to those found in malware used in Mirai-like botnets. Such activity would involve attempts to download the malware and execute on vulnerable devices, according to researchers. 
    • “The vulnerability was originally disclosed in June 2023, and proof of concept exploits appeared prior to the disclosure, wrote Unit 42 researchers. 
    • “The Cybersecurity and Infrastructure Security Agency previously added the command injection vulnerability, tracked as CVE-2023-33538, to its Known Exploited Vulnerabilities catalog in July 2025.” 

From the ransomware front,

  • The HIPAA Journal reports,
    • Brockton Hospital in Massachusetts is continuing [as of April 15] to grapple with a cybersecurity incident that took many of its electronic systems offline on April 6, 2026, and forced the hospital to divert ambulances to alternate facilities and cancel scheduled cancer treatments. An investigation into the cyberattack is ongoing, and the hospital is working with federal and state officials. While some systems have been brought back online, the hospital is continuing to use its downtime procedures, with staff members working off paper rather than computers. A Signature Healthcare spokesperson told Boston 25 News that the hospital would continue under downtime procedures for the next two weeks. * * *
    • “The Anubis ransomware-as-a-service group claimed responsibility for the attack. Anubis engages in double extortion, stealing data and encrypting files. A ransom must be paid to prevent the release of stolen data and obtain the keys to recover encrypted files. According to SuspectFile, which was contacted by a member of the Anubis group, files were encrypted in the attack. The Anubis spokesperson told SuspectFile that only non-critical systems were encrypted, and 2TB of data was stolen in the attack, including a large volume of patient data.
    • “Anubis is attempting to pressure Signature Healthcare into paying the ransom by adding the hospital to its data leak site, along with a countdown clock when the stolen data will be published. Signature Healthcare has yet to confirm the extent of data theft, which may not be known for some time. The priority continues to be patient care, remediating the attack, and bringing systems back online when it is safe to do so.”
  • Govtech relates,
    • “Ransomware continues to pose a serious threat to U.S. critical infrastructure, with more than 2,100 related incidents reported to federal authorities in 2025, according to the latest FBI Internet Crime Complaint Center (IC3) report.
    • “To put that number in perspective, IC3 reported roughly 1,100 data breach threats to critical infrastructure, which includes sectors such as health care, critical manufacturing, financial services, energy and agriculture, among others. Ransomware attacks directed at critical infrastructure are serious, possessing as they do the potential to disrupt operations, expose sensitive data and affect the delivery of public services.
    • “Those incidents have implications for state and local government organizations, which operate or support many of these systems. The nation’s critical infrastructure spans 16 sectors whose disruption would have a debilitating effect on the United States. Of these, the health-care and public health services sector reported the highest number of incidents, the report shows.”
  • SC Media adds,
    • “Analysis by Check Point researchers showed that out of the 672 ransomware attacks reported in March 2026, Qilin alone accounted for 20%, followed by Akira, which was responsible for 12% of the attacks, and Dragonforce RaaS, which was responsible for 8% of the incidents, reports Infosecurity News.”
  • and
    • “Suspected former Black Basta ransomware affiliates are ramping up targeting of senior-level executives with social-engineering attacks designed to deploy remote monitoring and management (RMM) software, ReliaQuest reported Tuesday.
    • “Black Basta, a previously notorious Russia-linked ransomware-as-a-service (RaaS), became defunct last year following leaked chats exposing its infrastructure and techniques. However, attacks leveraging the group’s distinct tactics, techniques and procedures (TTPs) have continued into 2026, with ReliaQuest noting an accelerating volume and increased targeting of company leadership.
    • “For example, Microsoft Teams-based phishing — a staple of Black Basta’s playbook — is becoming more prevalent, with 56% of all Teams phishing over the last year occurring within the last quarter, and nearly a third happening in March 2026 alone.”
  • Industrial Cyber notes,
    • “New data from Cyfirma disclosed that ransomware activity in March reflects a continuation of the sector’s shift toward structured, repeatable extortion models, where encryption is paired with data theft to maximize pressure on victims. The findings show that growing fragmentation of extortion groups suggests that smaller or emerging threat actor groups could adopt automation, AI-assisted reconnaissance, and data-driven victim profiling to scale operations efficiently. These campaigns rely heavily on coercive messaging, warning against third-party recovery attempts and reinforcing the risk of permanent data loss, underscoring how psychological pressure remains central to payment conversion strategies. 
    • “At the operational level, ransomware actors in March continue to refine rather than reinvent their tactics, prioritizing efficiency, scalability, and consistency across attacks. Cyfirma assesses that groups are likely to enhance encryption speed, standardize extortion workflows, and expand double extortion practices, while relying on common intrusion vectors such as phishing and exposed services. The broader trajectory points to incremental evolution within a mature ecosystem, where innovation is less about novel techniques and more about optimizing execution and monetization across a globally opportunistic threat landscape.” 
  • Security Boulevard informs us,
    • “Double extortion is bad enough—that’s the current tactic favored by ransomware groups—but the emerging quadruple extortion promises to further complicate mitigation and response by targeted organizations, prompting an escalation in extortion payments.  
    • “Yet that’s just one piece of evidence that ransomware continues to evolve despite high-profile takedowns by law enforcement—they just reincarnate or rebrand as new groups, new research by Akamai shows. Of course, the biggest game-changer is GenAI, as RasS operators like Black Basta and FunkSec press LLMs into service to generate code and greatly improve the social engineering techniques that give bad actors a foot in the door and to scale up attacks, opening the door for even less sophisticated actors to execute damaging attacks. 
    • “Ransomware groups continue to seek additional ways to generate profit, such as by pressuring victims and weaponizing compliance,”  researchers at Akamai note in their Ransomware Report 2025. 
    • “Noting that ransomware tactics have moved “away from traditional encryption-centric ransomware tactics towards more sophisticated and advanced extortion methods,” Nathaniel Jones, vice president, security and AI strategy and field CISO at Darktrace, says, “rather than relying solely on encrypting a target’s data for ransom, threat actors will increasingly employ double or even triple extortion strategies, encrypting sensitive data but also threatening to leak or sell stolen data unless their ransom demands are met.” 

From the cybersecurity defenses front,

  • The Wall Street Journal reports,
    • “The software bug was capable of crashing an operating system used by firewalls, servers and network appliances. It went undetected for over 27 years.
    • “Last month, it was caught by Mythos, the latest AI model from Anthropic that has spooked the White House, banking executives and cybersecurity professionals around the world.
    • Welcome to the bug armageddon. AI models like Mythos and others are finding bugs in older software at a rate never seen before.
    • “While most of the coding issues may be minor, their sheer volume has amplified the risk that smaller software developers will become overwhelmed with reports of bugs such as the one Mythos found. Thanks to AI, hackers will be able to leverage those bugs more quickly than ever before.
    • “The 1998 bug in the OpenBSD operating system was one of thousands Mythos found last month. Anthropic said last week that it is working with about 50 technology companies and organizations to find and fix bugs and currently has no plans to release Mythos to the general public.
    • “We need to know that we can release it safely, and it’s not exactly clear how we can do that with full confidence,” said Logan Graham, the head of Anthropic’s Frontier Red Team, which evaluates AI for risks.”
  • Security Week relates,
    • “To help security teams prepare for this future, the Cloud Security Alliance has developed and published The ‘AI Vulnerability Storm’: Building a ‘Mythos-ready’ Security Program. The report does not provide a solution, but it will help readers understand what is coming, and what they must do in preparation.
    • “Mythos will not fundamentally change the nature of cybersecurity. It primarily provides a step change in the pace of attacks, and the biggest single change will be the asymmetric advantage to the attacker increasing dramatically. Cybersecurity itself doesn’t change – it just needs to cope with a new ferocious pace. Best practice fundamentally remains the same, but its importance becomes more critical.
    • “Focus on the basics and harden your environment further,” say the CSA report authors. “Segmentation, egress filtering, multifactor authentication, and defense-in-depth/breadth all increase the difficulty for attackers.” Nothing there is new, but many firms have not done it adequately – and must rapidly start doing it effectively”
  • and
    • “OpenAI announced that it’s scaling its Trusted Access for Cyber program to thousands of verified defenders and hundreds of security teams. They will be given access to GPT-5.4-Cyber, a fine-tuned variant of GPT-5.4 that relaxes the usual guardrails for legitimate cybersecurity work. 
    • “GPT-5.4-Cyber also provides new capabilities such as binary reverse engineering, which enables users to analyze compiled executable software for vulnerabilities and malicious behavior.
    • “The new AI model is initially being offered on a limited, iterative basis to vetted security vendors, organizations, and researchers.
    • “Individual defenders who want to enroll into the Trusted Access for Cyber program and test GPT‑5.4‑Cyber can apply through chatgpt.com/cyber via an identity verification process, while enterprise teams must go through their OpenAI account representative.” 
  • Cyberscoop adds,
    • “A joint report from the Cloud Security Alliance (CSA), the SANS Institute and the Open Worldwide Application Security Project (OWASP) concludes that in the near term, organizations are “likely to be overwhelmed” by threat actors using AI to find and exploit vulnerabilities faster than defenders can patch them.
    • “While those organizations can use AI tools to speed up their own defenses, attackers “still face a heavier relative burden due to the inherent limitations of patching. This in turn leads to “asymmetric benefits” for attackers who can afford to adopt the technology without the same caution and bureaucracy as a multi-billion dollar business.
    • “The cost and capability floor to exploit discovery is dropping, the time between disclosure and weaponization is compressing toward zero, and capabilities that previously required nation-state resources are now becoming broadly accessible,” wrote Robert Lee, SANS Institute’s Chief AI Officer, Gadi Evron, CEO of Knostic and Rich Mogull, chief analyst at CSA, who served as the primary authors.”
  • TechTarget tells us, “How CIOs can beat AI challenges: A top researcher’s view.”
    • “CIOs are grappling with moving AI from the pilot stage to genuine implementation, and many are encountering organizational pitfalls that are stalling the delivery of real value.”
  • Healthexec informs us,
    • “Hospitals have always had to rely on multitudes of healthcare vendors to keep operations humming. In recent years the arrangement’s inherent management challenge has only grown more complex. 
    • “That’s largely because myriad AI technologies have changed daily life for provider organizations and industry partners alike. Arguably the biggest single difficulty to emerge from the transformation is the risk of cybersecurity breaches. 
    • “The Health Sector Coordinating Council (HSCC) is taking a crack at helping cybersecurity leaders, teams and stakeholders clear a path through the thicket. The assistance comes in the form of a 109-page document titled Third-Party AI Risk and Supply Chain Transparency Guide.
    • “The guidebook is authored by members of an HSCC working group focused on cybersecurity. The team’s guiding aim for the project was to “address the growing gaps in discovery and disclosure processes that make AI supply chain risk so difficult to manage.”
  • A NIST press release announced
    • “NIST SP 800-133 Rev. 3 (Initial Public Draft) Recommendation for Cryptographic Key Generation
    • “Proposed changes in this revision include the following:
      • “Asymmetric key-pair generation has been expanded to include methods for deriving randomness during key-pair generation.
      • “Key-pair generation now has options for derivation similar to symmetric keys and new methods for “seed expansion,” which allows for the limited use of SHAKE and deterministic random bit generators (DRBGs).
      • “Key-encapsulation mechanisms (KEMs) are discussed as a key-establishment option for symmetric key generation, and post-quantum cryptography (PQC) references have been added throughout (e.g., the new PQC signatures).
      • “Text has been reworded to address random number generation in alignment with SP 800-90C.
    • “Comments are especially requested regarding:
      • “Hardware security module (HSM) design — How do these requirements align with common practice and existing systems using a root seed/secret value?
      • “PQC implementations and protocol — How do these requirements fit with storing keys as seeds (e.g., for ML-KEM) and performing hybrid (i.e., combined classical and post-quantum) implementations?”
  • Here is a link to Dark Reading’s CISO Corner.