FEHBlog

Friday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical / Rx research front,

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

From the HIMSS Conference 2026 front,

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

From the U.S. healthcare business front,

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

Thursday report

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health, medical and Rx research front,

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

From the HIMSS Conference 2026,

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

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

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

Midweek report

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

From Washington, DC

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

From the Food and Drug Administration,

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

From the public health, medical and Rx research front,

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

From the HIMSS conference front,

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

From the U.S. healthcare business front,

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

Tuesday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the HIMSS conference front,

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

From the U.S. healthcare business front,

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

Monday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Weekend Update

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

Happy International Women’s Day!

From Washington, DC,

  • Roll Call outlines Congressional activities for the week.
  • The New York Times reports that “Health Care Has Become the Lifeblood of the Labor Market.”
    • “An aging population is drawing workers to medical and social care, creating reliable jobs and revealing weakness for the rest of the economy.”
  • CNN adds,
    • “Hiring at US businesses unexpectedly plunged last month as employers shed an estimated 92,000 jobs, according to new data released Friday by the Bureau of Labor Statistics.
    • ‘The unemployment rate edged higher to 4.4% from 4.3%.
    • “Economists were expecting job growth to slow somewhat after a surprisingly strong January – in part due a major labor strike by health care workers and a deep cold snap that hit many US states. The consensus estimates were for a net gain of 60,000 jobs and the unemployment rate to hold steady, FactSet estimates show.
    • “We had a labor market that nearly froze last year, and it seemed to show some signs of thawing, which made it slushy at best,” Diane Swonk, chief economist at KPMG US, told CNN in an interview.
    • “February’s report, however, showed how precarious the US jobs market is when the supporting “one-legged stool” of health care is kicked out, she said. The health care industry, which has driven the vast majority of the job gains in the past year, posted a loss of 28,000 jobs (31,000 of which were likely attributed to the mid-month Kaiser Permanente nurses and health care workers strike [which recently ended).”
  • Federal News Network offers guidance on how FEHB/PSHP work together for federal and postal annuitants.

From the judicial front,

  • Healthexec tells us,
    • “An alleged conspiracy involving two drug suppliers and several doctors tied to the diversion and resale of nearly $50 million in medications has led to a series of guilty pleas, the U.S. Department of Justice from the District of New Jersey announced Tuesday [March 3].
    • “The two men who most recently pleaded guilty—Frank Incognito, 46, and Stephen Corba, 50, both from New Jersey—were the operations manager and owner of a wholesale drug seller, respectively. The name of the company was not revealed.
    • “According to prosecutors, the duo worked with doctors to resell cancer and ophthalmology medications, purchasing them from licensed distributors under false pretenses. Because Incognito and Corba were unable to buy the pharmaceuticals themselves, they relied on physicians to make “straw purchases” in exchange for kickbacks.
    • “The doctors would promise manufacturers the drugs were being purchased for their patients. Instead, they slipped them to Incognito and Corba, who then resold the medications on the black market at significant profit.” * * *
    • “Three physicians—Anise Kachadourian, MD; Jon Paul Dadaian, MD; and Joel Lerner, MD—previously pleaded guilty for their roles in the conspiracy. The DOJ did not provide details about their sentencing status.” 

From the public health and medical / Rx research front,

  • Virtual Capitalist informs us,
    • “West Virginia has the highest diabetes prevalence in the U.S., with 15% of adults diagnosed.
    • “Vermont reports the lowest rate at 7.7%, nearly half the level of the highest states.
    • “Many Southern states report rates well above the national average of 10.3%.”
  • Point-Counterpoint. The Washington Post reports,
    • “The miracle of rapid weight loss has always come with fine print. Until recently, it read mostly like a list of digestive complaints —stomachaches, constipation — generally unpleasant but tolerable and rarely severe. New research presented this month suggests the drugs may affect something more structural: bone.
    • “In an analysis of nearly 150,000 patients, researchers found that people taking GLP-1 medications faced a significantly higher risk of skeletal disorders.
    • “Over five years, the risk of osteoporosis — a disease that weakens bones and makes them brittle — was nearly 30 percent higher. The risk of gout, a painful inflammatory arthritis which results from needlelike crystals forming in the joints, rose 12 percent. And the risk of osteomalacia, a softening of the bones caused by a low mineral-to-bone ratio that was rarer in the study, increased by more than 150 percent.
    • “It was a lot more than I expected,” said John Gabriel Horneff, one of the study’s authors and an associate professor of clinical orthopedic surgery at the University of Pennsylvania.
    • “The data was presented this month at the American Academy of Orthopaedic Surgeons’ annual meeting and drawn from electronic health records contained in a national database.”
  • Evidently, according to Health Day, another perspective on this issue was presented at this conference.
    • “Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for type 2 diabetes and obesity is independently associated with a significantly increased five-year risk for osteoporosis, gout, and osteomalacia compared with nonuse, according to a study presented at the annual meeting of the American Academy of Orthopaedic Surgeons, held from March 2 to 6 in New Orleans.
    • “Muaaz Wajahath, from the Michigan State University College of Human Medicine in East Lansing, and colleagues evaluated the five-year risk for osteoporosis, gout, and osteomalacia in adults with both type 2 diabetes and obesity treated with GLP-1 RAs (semaglutide, liraglutide, dulaglutide, or exenatide) compared with matched controls (73,483 per group).
    • The researchers found that at five years, patients exposed to GLP-1 RAs had a significantly increased risk for osteoporosis compared with controls (4.1 versus 3.2 percent; risk ratio, 1.29). Gout incidence also was elevated among GLP-1 RA users (7.4 versus 6.6 percent; risk ratio, 1.12). Osteomalacia had the greatest relative risk increase, with a five-year incidence of 0.2 percent among GLP-1 RA users compared with 0.1 percent in the control group (risk ratio, 2.55). There was statistical significance for all differences in absolute and relative risk.”
  • Healio adds,
    • “Women who start early menopausal hormone therapy after menopause have a lower risk for osteoporosis over a 5-year period, according to data presented at the American Academy of Orthopaedic Surgeons Annual Meeting.
    • “We know that with the aging population, fragility fractures are going to be a real problem in the future, and HRT is protective and may decrease the fracture burden,” James M. Barsi, MD, clinical associate professor in the department of orthopaedic surgery at Stony Brook University, told Healio.”
  • MedPage informs us,
    • “A machine learning model for prediction of preeclampsia risk using routinely collected data was feasible, according to a retrospective cohort study of pregnancies in late gestation.
    • “Patients who developed preeclampsia were older and more frequently Black.
    • “The most informative predictor in the model was blood pressure.”
  • Medscape points out,
    • “Chronic rhinosinusitis may be linked to an increased risk for cancer, according to a study of patients in Asia. 
    • “The study found that chronic rhinosinusitis was linked to an 18% increased risk for cancer in Korean patients and a 63% increased risk for cancer in patients from Japan. The results provide the first large-scale evidence for an association between chronic rhinosinusitis and the risk for cancer, suggesting a possible role for cancer surveillance in patients with the inflammatory condition, researchers said.
    • “This study suggests that certain chronic inflammatory conditions may be associated with an increased risk of cancer development and could warrant heightened cancer surveillance, particularly in middle-aged and older populations,” Seong H. Cho, MD, professor of medicine and pediatrics at the University of South Florida Health Morsani College of Medicine in Tampa, Florida, said. “While the consistency across both Asian populations strengthens the validity of the findings, confirmation in the US and other Western populations is essential before broad global application.”

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

  • The Health Information and Management Systems Society (HIMSS) Global Health Conference & Exhibition 2026 begins today in Las Vegas.
  • For example, Bloomberg informs us,
    • “Oura Health is buying a gesture-recognition startup, setting up the company to eventually add such controls to its popular line of smart rings.
    • “Oura said it is acquiring Helsinki-based Doublepoint Technologies Oy, which specializes in technology that allows users to control wearable devices with small hand movements using a combination of artificial intelligence and biometric data. The purchase will guide future versions of Oura’s smart rings, where hand gestures could play a central role to the experience, along with possibly voice control, Chief Executive Officer Tom Hale said in an interview. Terms of the deal were not disclosed.”
  • Beckers Payer Issues reports,
    • “Network Health, a Wisconsin-based insurer owned by Froedtert ThedaCare Health, grew 37% during this past annual enrollment period to 126,000 total Medicare Advantage members, its second consecutive year of record growth. The plan also posted a 98% member retention rate.
    • “The results make Network Health the second largest MA carrier in its 27-county service area, behind only UnitedHealthcare.” * * *
    • “One initiative that has distinguished Network Health nationally is its integration of Mark Cuban’s Cost Plus Drugs into its MA pharmacy network, making it one of the first plans in the country to do so when it first launched in early 2025. Ms. Dicus-Johnson [, the CEO,] said she first encountered Cost Plus Drugs four years ago and immediately wanted to bring the model to Network Health’s members. 
    • “Unlike coupon-based programs or out-of-pocket reimbursement models, Network Health built a fully electronic claims integration model with its PBM, Express Scripts, so prescriptions are processed in real time with no paper claims required. Mail-order benefits apply automatically, and eligible medications count toward members’ Part D accumulators.”
  • and
    • “Clover Health said it is the first health insurer to be live on a CMS-aligned network for patient-directed requests, according to a March 4 news release from the company.
    • “While CMS previously listed other payers as “early adopters” of CMS-aligned networks, a Clover spokesperson clarified the company was the first to fully integrate with a government-backed network. In this case, Clover integrated with Kno2, the patient information exchange. Kno2 is a qualified health information network under the Trusted Exchange Framework and Common Agreement, and it is also a CMS-aligned network.
    • “These networks are data exchanges that voluntarily follow CMS’ interoperability framework. By leveraging its AI physician-enablement platform Counterpart Health, Clover can respond to patient requests for claims and clinical data in real time, the release said.”
  • Beckers Hospital Review notes,
    • “Eight-four percent of primary care providers said they must play an essential role in meeting rising demand for mental and behavioral health treatment in the U.S, according to a Medscape survey published March 6. 
    • “The Health Resources and Services Administration’s Bureau of Health Workforce data found the number of designated mental health professional shortage areas rose from 6,418 to 6,807 in 2025, increasing pressure on primary care providers to address patients’ behavioral health needs.” 

Notable Death

  • The Washington Post reports,
    • “Paula Doress-Worters, who helped break the silence on postpartum depression, dies at 87
    • “She co-wrote “Our Bodies, Ourselves,” a 1970s touchstone conceived by and for women. The book offered information about abortion, pregnancy and postpartum life.”
  • RIP.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the Iran War front,

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

From the cybersecurity policy and law enforcement front,

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

From the cybersecurity breaches and vulnerabilities front,

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

From the ransomware front,

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

From the cybersecurity business and defenses front,

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

Friday report

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Federal News Network reports,
    • “The U.S. Postal Service will run out of cash within a year unless Congress lifts a decades-old cap and allows the agency to borrow more money, the new postmaster general warned in an interview.
    • “If it doesn’t, the Postal Service might not be able to pay its employees or vendors by February 2027, with potentially dire consequences for mail delivery, Postmaster General David Steiner told The Associated Press.
    • “How long are employees going to work and vendors going to show up if we’re not paying them?” Steiner said in an interview on Wednesday.
    • “The postmaster general is scheduled to testify before Congress later this month about the Postal Service’s financial struggles and the need to change longstanding rules and regulations that he considers burdensome. He singled out the $15 billion cap on borrowing that has been in place since 1990.”
  • Per an HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced $69.1 million in funding opportunities for three grant programs: the Children’s Mental Health Initiative (CMHI), Implementing Zero Suicide in Health Systems (Zero Suicide) and Assisted Outpatient Treatment (AOT).
    • “Last month, I launched a comprehensive plan to strengthen prevention, expand treatment, and advance President Trump’s Great American Recovery Initiative,” said U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. “These grants will directly address the root causes of addiction — including homelessness and serious mental illness — and strengthen community safety by expanding treatment that prioritizes recovery, stability, and self-sufficiency.”
    • “Recovery is possible, and these investments help communities reach people earlier with the support and treatment that can change lives,” said Senior Advisor for Addiction Recovery Kathryn Burgum. “By expanding access to evidence-based mental health services and strengthening community partnerships, we are helping more Americans find a path to healing and stability.”
  • STAT News adds in an editorial piece,
    • “In a political moment defined by division, it is telling that former Rep. Patrick Kennedy (D) and health secretary Robert F. Kennedy Jr. are attempting to find common ground on on one issue: the urgent need to take mental health and addiction seriously as national priorities.” * * *
    • “The urgency for our nation’s leaders to act is underscored by sobering data. Suicide remains one of the leading causes of death for young people. Anxiety and depression among adolescents have risen sharply over the past decade. Alcohol-related deaths continue to climb while overdose deaths remain high, particularly in communities already facing economic and health disparities. The economic toll of mental illness and addiction now reaches hundreds of billions of dollars annually — costs borne by families, employers, health systems, and taxpayers.
    • “In the discussion about this crisis, one fact is routinely overlooked: These conditions are often preventable in the first place. If the health secretary is serious about making America healthier, preventing behavioral health disorders is one place to start.”
  • Earlier this week, Blue Shield of California Paul Markovich and others launched a healthcare political movement called Worthy. Check it out.
  • Fierce Healthcare relates,
    • “Just over 56 million people are enrolled in Medicare Part D, with the share of those securing coverage through Medicare Advantage Prescription Drug (MAPD) plans growing alongside the overall program.
    • “As of 2026, 24.9 million people were enrolled in standalone Part D plans, according to a new analysis from KFF, while 31.4 million were in MAPD plans. By comparison, overall enrollment in 2006 was just 21.8 million, with 15.8 million of those individuals with just Part D coverage.
    • “The data for 2026 do reflect slight growth year over year in the number of people with standalone Part D, as 23.2 million were enrolled in just the prescription drug coverage for 2025.
    • “The report found that enrollment in non-group MAPD plans has steadily risen over the past several years, while sign-ups for non-group standalone prescription coverage has plateaued.
    • “Meanwhile, it’s the opposite story in employer group Medicare, according to the report. Enrollment in employer group MAPD plans fell from 3.9 million to 2.7 million between 2025 and 2026, while sign-ups for group Part D plans rose from 5.1 million to 6.3 million.
    • “This marks the first time enrollment in employer group MAPD coverage has declined, the KFF researchers said.
    • “The researchers note that this shift may be in response to the Part D premium stabilization program, instituted last year, which is applicable only in standalone prescription plans and not MA plans. In employer Part D plans, the program would afford $10 per member per month in additional subsidies.”

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration’s controversial vaccines chief is leaving the agency.
    • “Dr. Vinay Prasad, who has led the FDA’s vaccines and biotech drugs division, will depart at the end of April, FDA Commissioner Marty Makary said Friday. Federal health officials are searching for his replacement, Makary said.”
  • Per an FDA press release,
    • “Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer. The gathering was the latest step toward the FDA’s implementation of President’s Trump’s executive order on lowering drug prices. 
    • “The meeting provided a forum to exchange information, with the goal of making it easier for states that have expressed interest in the program to obtain authorization without sacrificing safety or quality. Representatives from HHS and the National Academy for State Health Policy also participated.
    • “We are committed to lowering prescription drug prices for Americans, building on recent MFN wins,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re moving forward to implement the president’s executive order as we continue the crucial work of helping states and Indian tribes import reduced cost prescription drugs, while protecting public health and safety.” * * *
    • “Presentations from yesterday’s meeting are available for download at: Section 804 Importation Program Policies and Authorizations.”
  • The American Hospital Association News points out,
    • “The Food and Drug Administration March 5 issued a request for information seeking public comments on potential new standards for in-home opioid disposal products. The FDA said it is considering whether to require opioid sponsors to make in-home disposal systems available through dispensers. Comments are due April 6.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration has approved a regimen involving Johnson & Johnson’s antibody drugs Tecvayli and Darzalex for relapsed multiple myeloma less than three months after the drugmaker presented study data suggesting the combination could have curative potential.   
    • “The regulator reviewed the drug under its new “national priority voucher” program, which it used “proactively” following J&J’s release of the findings at the American Society of Hematology meeting. The approval issued Thursday was the third under that program, following that of an older antibiotic and a lung cancer treatment from Boehringer Ingelheim. The review took a total of 55 days, according to the FDA.
    • “The decision also converts Tecvayli’s authorization from a conditional, “accelerated” approval to full clearance that’s based on its ability to improve survival in early disease.”
  • Cardiovascular Business informs us,
    • “The U.S. Food and Drug Administration (FDA) is sharing additional information about a series of recalls for certain electrophysiology (EP) and ultrasound catheters from Medline Industries. The agency emphasized that these devices should be destroyed immediately as opposed to being set to the side or returned to the manufacturer.
    • “Back in February, Medline Industries recalled several reprocessed catheters after discovering that they may contain small traces of residual material that could harm a patient. The catheters were originally made by a variety of vendors, but Medline Industries reprocessed the devices and then sold them again. Reprocessing single-use devices is a central component of the company’s business model, and it estimates this diverts more than 1 million pounds of waste from landfills each year. 
    • “Initial details about these recalls first appeared in an FDA database in February. However, this new advisory is the first time the agency has warned the public about these concerns.”

From the judicial front,

  • Govexec reports,
    • “A coalition of federal employee unions and other employee advocacy groups this week renewed their effort to block the implementation of President Trump’s plan to convert tens of thousands of federal workers into at-will employees who can be fired for virtually any reason, arguing that Trump exceeded his authority and violated federal law in advancing the policy.
    • “On Trump’s first day back in office last year, he signed an executive order reviving Schedule F, the abortive 2020 proposal to move feds in “policy-related” positions out of the competitive service and stripping them of most civil service protections, and renaming it “Schedule Policy/Career.” Final regulations implementing the policy are set to take effect next week, after which Trump is expected to sign an additional executive order formally converting the first tranche of positions into the new job category. Officials have estimated around 50,000 employees will be targeted for conversion.
    • “On Wednesday, the American Federation of Government Employees, the American Federation of State, County and Municipal Employees, the AFL-CIO, Public Employees for Environmental Responsibility and Democracy Forward filed an amended complaint in their lawsuit challenging Schedule Policy/Career, which began in January 2025 in the U.S. District Court for Maryland, incorporating new details that arose in the 14 months that the administration has spent preparing to launch the new excepted service job category.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “RSV activity started later than expected in most regions of the United States, though severity is not higher compared with recent seasons. This atypical season indicates that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally. COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “COVID-19
      • “COVID-19 activity is decreasing nationally but remains elevated in some areas of the country.
    • “Influenza
      • “Seasonal influenza activity remains elevated nationally. Influenza A activity is decreasing in most areas of the country while trends in influenza B activity vary by region.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity has started later than expected in most regions of the United States, though severity is not higher compared with recent seasons. This atypical season indicates that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
    • “Vaccination
      • “RSV is a leading cause of hospitalization among U.S. babies.
      • “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
        • “The pregnant mother gets the RSV vaccine during pregnancy, or
        • “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
      • “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.”
  • The University of Minnesota’s CIDRAP relates,
    • “Children under two years of age hospitalized for COVID-19 are more likely to die or become seriously ill than babies with respiratory syncytial virus (RSV), according to a study  published this week in Open Forum Infectious Diseases. 
    • “Babies can become sick and die from both respiratory viruses, even if they were healthy before becoming infected, according to the study, which was led by researchers from the US Centers for Disease Control and Prevention.” * * *
    • “Although RSV immunizations were approved in 2023, they were not yet widely available during the study. Only 5.5% of babies age six to 23 months were vaccinated against COVID-19 in the study.
    • “Research shows that vaccinations for both RSV and COVID-19 are safe and effective. The American College of Obstetricians and Gynecologists recommends women receive a COVID-19 vaccine at any time during pregnancy and an RSV vaccine between the 32nd and 36th week of pregnancy. Both vaccines can protect newborns too young to be vaccinated. 
    • “For babies whose mothers weren’t vaccinated against RSV, the American Academy of Pediatrics recommends newborns under 8 months receive an injection of lab-grown antibodies. The pediatric group also recommends babies age six to 23 months be vaccinated against COVID-19.”
  • The AHA News reports,
    • “The South Carolina Department of Public Health March 6 reported that the state’s measles outbreak is at 991 cases. The agency said the vaccination status of 925 cases is unvaccinated, 26 are fully vaccinated, 19 are partially vaccinated and the status of 21 cases is unknown. Additionally, the agency reported that more than 17,300 doses of the measles vaccine were administered statewide last month, a 70% increase compared to February 2025. Nationwide, 1,277 confirmed measles cases have been reported this year to the Centers for Disease Control and Prevention. Of those, 5% of all cases have been hospitalized and no deaths have been reported.” 
  • USA Today relates,
    • “International travel often comes with vaccine reminders, and the Centers for Disease Control and Prevention is now warning travelers to ensure their polio vaccinations are up to date.
    • “The CDC issued a level 2 travel advisory on March 3, warning that poliovirus has been detected in multiple destinations within the past 12 months – including parts of Africa, the Middle East and Europe.” 
  • Healio tells us,
    • “In-hospital mortality was significantly higher for younger women vs. younger men after a first heart attack, with women receiving fewer cardiac procedures and having more nontraditional cardiovascular risk factors, researchers reported.
    • “A study evaluating trends in first MI outcomes, both STEMI and non-STEMI, based on sex was published in the Journal of the American Heart Association.”
  • Health Day informs us,
    • “Regular cannabis users may be more likely to experience anxiety, depression or suicidal thoughts than non-users
    • “Rates of generalized anxiety and major depressive episodes among Canadians have nearly doubled since 2012
    • “Younger people show the strongest cannabis-mental health link.
  • Genetic Engineering and BioTechnology News notes,
    • “According to a new Stem Cell Reports paper, scientists have demonstrated that targeted delivery of mRNA can restore sperm production and fertility in genetically infertile male mice without introducing permanent changes to the germline. Full details are provided in a paper titled “Messenger RNA delivery into Sertoli cells restores fertility to congenitally infertile male mice.” The study was done by a team of scientists from Kyoto University, RIKEN, and elsewhere.  
    • “The findings represent a step forward in efforts to develop therapies that may help people affected by infertility.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “The Mayo Clinic ended 2025 with income over 13% higher than the year before, as the nonprofit health system was buoyed by increased volumes and demand for healthcare services, according to earnings documents released this week.
    • “The Rochester, Minnesota-based nonprofit health system said increases in its outpatient, hospital and surgical volumes accounted for the rise in revenue compared to the year prior.
    • “Still, as revenues rose, so too did expenses. Mayo’s increase in volumes drove supply and services expenses up, contributing to an over 8% year-over-year increase in operating costs, according to the health system.”
  • Modern Healthcare adds,
    • “Many large health systems are on the upswing financially — at least for now.
    • “Health systems are seeing improved margins as they benefit from higher volumes, investment returns and technology-driven efficiency efforts. They are betting that a stronger balance sheet will help offset the coming reimbursement cuts. 
    • “Nonprofit health systems addressed these issues in quarterly and full-year earnings reports released over the past few weeks. Here are five key themes from those reports.
      • “Systems are strengthening their margins
      • “Investment income is driving profits
      • “Cash on hand is improving
      • “Non-labor expenses are climbing, and
      • “Systems are bracing for what’s ahead.”
  • Beckers Hospital Review tells us,
    • “Fairfield, Calif.-based NorthBay Health has signed a letter of intent to acquire Providence Queen of the Valley Medical Center in Napa, Calif., a move that would expand the system to three hospitals.”
  • and
    • “Franklin, Tenn.-based Community Health Systems has signed a definitive agreement to sell four Arkansas hospitals to Freeman Health System for $112 million.” 
  • STAT News relates,
    • “Generic versions of Novo Nordisk’s blockbuster Wegovy and Ozempic medications could be mass produced for about $3 per person per month, a cost that could greatly widen access in low- and middle-income countries, according to a new analysis.
    • “After reviewing data for active pharmaceutical ingredients from the past two years, the researchers estimated a generic version of semaglutide — the key ingredient in the Ozempic diabetes treatment and Wegovy weight loss drug — could be made for $28 to $140 per person a year and then sold at low prices once patents expire this year in several countries.
    • “Specifically, patents for semaglutide are due to expire starting later this month in India, China, Canada, Brazil, and Turkey, along with three other countries later this year, which is expected to spark distribution of generic versions. This is especially true of India, where numerous generic makers are based and are seeking new markets.
    • “The standard dose of semaglutide is 2.4 milligrams per week as an injection, which is the equivalent of 10 mg per month. This is a very small amount of drug, which is why the cost of production is so low,” said Andrew Hill, a University of Liverpool pharmacology professor, who has previously analyzed production costs for HIV, cancer, and hepatitis drugs. “These low prices open the door to worldwide access to an essential medicine.”
  • Fierce Pharma informs us,
    • “As nonprofit-governed Servier continues to make gains with its IDH-mutant glioma med Voranigo, the drugmaker is wading deeper into the rare oncology arena with a new M&A play. 
    • “Servier on Friday unveiled a definitive agreement to acquire Day One Biopharmaceuticals—a commercial-stage company developing targeted therapies for pediatric cancers and other diseases—for $21.50 per share in cash. The total value of the deal, which is expected to close in the second quarter, comes to roughly $2.5 billion, the companies said in a March 6 release.” 
  • Per BioPharma Dive,
    • “Blackstone Life Sciences is widening its presence in drug development, announcing Tuesday a $400 million commitment over four years to support Teva Pharmaceutical’s work on a late-stage gut disease drug likely to be in a hotly contested class.
    • “Per deal terms, if the drug, called duvakitug, gains Food and Drug Administration approval, Teva will owe a milestone payment to Blackstone, along with additional payouts and royalties based on commercial sales. Blackstone has signed similar deals with Moderna, Alnylam Pharmaceuticals and Autolus Therapeutics.
    • “Duvakitug is in Phase 3 clinical trials that will enroll more than 3,000 people with ulcerative colitis or Crohn’s disease and follow them for up to 40 weeks. The deal will help subsidize Teva’s research and development spending, which topped $1 billion in 2025.”
  • Per MedTech Dive,
    • “MiniMed, Medtronic’s diabetes tech spinoff, made its debut on the public markets Friday. 
    • “The company started trading on the Nasdaq under the ticker “MMED.” MiniMed offered 28 million shares priced at $20 each, for a total value of $560 million.
    • “The amount was below the $25 to $28 per share suggested by the company in filings last month.
    • “MiniMed has a market capitalization of about $5.29 billion, according to Yahoo finance.” 

Thursday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

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

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

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

From Washington, DC

  • The Hill reports,
    • “The House on Wednesday advanced a GOP-backed Department of Homeland Security (DHS) funding bill, an effort by Republicans to pressure Democrats to end the partial government shutdown in the wake of the U.S. launching strikes against Iran.
    • “The panel voted 211-209 to pass the rule, which tees up debate and a vote on the final passage of the measure. The bill is expected to pass the lower chamber on Thursday.”
  • Roll Call relates,
    • “The White House tentatively aims to release President Donald Trump’s fiscal 2027 budget proposal the week of March 30, according to multiple sources with knowledge of the plan.
    • “That timing would put budget delivery some eight weeks after the statutory due date of the first Monday in February, though presidential budgets often miss that deadline.
    • “Office of Management and Budget staff couldn’t immediately be reached for comment.”
  • Federal News Network tells us,
    • “Agencies would make layoff decisions based more highly on federal employees’ performance, rather than how long they have been working in government, according to a new proposal from the Trump administration.
    • “If finalized, proposed regulations that the Office of Personnel Management (OPM) is expected to publish Thursday morning would reorder the factors that agencies consider when determining which employees to retain or remove during a reduction in force (RIF).
    • “When it comes to personnel decisions during RIFs, current federal regulations tell agencies to first look at employees’ tenure and length of service, before considering their performance ratings. The new proposed regulations seek to reverse that order, making employee performance the top priority.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) and the National Aeronautics and Space Administration (NASA) today announced the launch of NASA Force, a dedicated talent track within the US Tech Force initiative designed to recruit and deploy the nation’s top engineers and technologists to support America’s space program.
    • “NASA Force will identify and place high-impact technical talent into mission-critical roles supporting NASA’s exploration, research, and advanced technology priorities, ensuring the agency has the cutting-edge expertise needed to maintain US leadership in space.”
  • Healthcare Dive informs us,
    • “Federal regulators received a record number of comments on their proposal to keep Medicare Advantage rates flat next year, Trump administration officials said Tuesday during an industry event, as insurers continue to lobby heavily for higher reimbursement.
    • “We appreciate all the input. I mean, obviously there’s been a little bit more input this year than we typically get,” John Brooks, the CMS’ chief policy and regulatory officer, said during the Better Medicare Alliance’s summit in Washington, D.C.
    • “In January, the Trump administration proposed an average rate bump of less than 0.1% for MA plans in 2027, along with tighter guardrails around how plans adjust for the health risks of their members.” * * *
    • “Regulators received almost 47,000 comments on the rule during the input period ended Feb. 25 — an all-time high, according to Brooks.
    • “In their comments, major MA carriers like UnitedHealth along with industry associations like the BMA and AHIP argued that the CMS ignored rising costs, resulting in a payment proposal underfunding MA.”
  • and
    • “The CMS innovation center is exploring more mandatory payment models as the Trump administration brainstorms how to get more providers to participate in value-based care, health officials said Tuesday.
    • “Mandatory models are going to have to be part of the equation,” CMMI Director Abe Sutton said at a conference hosted by value-based care advocacy group Accountable for Health.
    • “The CMMI tests ways of injecting more value-based care into federal programs through its models, which can be mandatory or voluntary. Mandatory models require all eligible participants — usually providers — to take part. Participants generally can’t exit the model before the testing period is up.
    • “That’s opposed to voluntary models, in which accountable care organizations or other actors can opt into participation.” * * *
    • “The CMMI started trialing more mandatory models during the first Trump administration, a direction that continued under President Joe Biden. Now, the second Trump administration is once again reiterating its support of expanded mandatory tests.”
  • Cardiovascular Business points out,
    • “The U.S. Centers for Medicare and Medicaid Services (CMS) has released a list 2,600 cardiologists who will be required to participate in a new Ambulatory Specialty Model (ASM) payment model for heart failure starting on Jan. 1, 2027.
    • “CMS said the new program aims to improve prevention and upstream management of high-cost chronic diseases with an initial push in heart failure and lower back pain. The new payment model is an attempt to reduce avoidable hospitalizations and unnecessary procedures. Heart failure is a major driver of Medicare expenses, and currently costs the U.S. health system about $179.5 billion annually.[1]
    • “Participation in the ASM will be mandatory for certain specialists who commonly treat these conditions in Medicare patients in an outpatient setting. The ASM will begin on Jan. 1, 2027, and run for five performance years through Dec. 31, 2031.”
  • Beckers Hospital Review notes,
    • “For the third time since March 2025, HHS has postponed a planned meeting for the U.S. Preventive Services Task Force, which provides clinical preventive health recommendations to Congress every year. 
    • “The USPSTF, which is a volunteer panel of national experts that was launched in 1984, usually meets three times a year. The group did not meet in July or in November of 2025, with the latter tied to a government shutdown. * * *
    • “An HHS spokesperson confirmed the March 2026 meeting’s postponement to Becker’s, adding that the meeting “will be rescheduled in the coming months.”

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Food and Drug Administration officials are giving Prime Medicine new hope for a gene-editing treatment the company was forced to shelve last year.
    • “The therapy, PM359, is designed to treat chronic granulomatous disease, or CGD, a potentially deadly condition that leaves patients highly susceptible to bacterial and fungal infections. A study of two patients released last year suggested PM359 could correct the genetic anomaly that causes the disease, offering the possibility of a cure.
    • “But the condition is so rare that Prime opted not to continue development of the therapy amid a cash crunch. Even as it announced the promising early results, Prime said it would deprioritize PM359 and focus on other programs after cutting a quarter of its staff. On Tuesday, Prime said it now sees the possibility of approval based on the two-patient study alone.”

From the judicial front,

  • STAT News reports,
    • “For the fourth time, federal auditors have turned up improper or potentially improper Medicaid payments in every sample of autism therapy records they audited. This report, focused on Colorado, yielded the highest improper payment amount yet. 
    • “The Department of Health and Human Services’ Office of Inspector General uncovered $285.2 million in improper and potentially improper payments in 2022 and 2023 to clinicians who provide a popular form of autism therapy called applied behavior analysis, or ABA. The payments, administered under Colorado’s Medicaid program, come from the state and federal governments. 
    • “HHS OIG announced in 2022 it would conduct reviews of Medicaid payments to ABA providers in seven states. The first was Indiana, then Wisconsin, and Maine. ABA is a commonly used therapy for managing autism symptoms, but a 2022 STAT investigation found that a rapid influx of private equity investment in the industry has contributed to a crisis of providers routinely overbilling insurers while providing substandard treatment to vulnerable children and families.” 

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • Heard about a lot of people getting flu this winter but not much about covid?
    • It’s not just you. For the second winter in a row, the United States has faced a punishing flu season, with covid as a more muted threat.
    • Early in the covid pandemic, coronavirus proved far more transmissibleand deadly as it ripped through the world than the flu typically was. Flu was almost nonexistent that first pandemic winter in 2020-2021.
    • Now that SARS-CoV-2 is no longer a novel virus sweeping through a population with little immunity, covid and influenza illnesses are becoming more similar, with a key difference: Coronavirus circulates year-round and ticks up in the summer, when flu is gone.
    • “Does that mean flu is now the woe of the winter, and covid is the scourge of the summer? It’s complicated and too soon to say.”
  • The American Hospital Association relates,
    • “The U.S. maternal mortality rate fell to 17.9 deaths per 100,000 live births in 2024, statistically similar to the 2023 rate of 18.6 per 100,000, according to data from the Centers for Disease Control and Prevention. The CDC reported that the maternal mortality rate for Black women in 2024 was 44.8 deaths per 100,000 live births, significantly higher than rates for white (14.2), Hispanic (12.1) and Asian (18.1) women. 
    • “The AHA is committed to safeguarding mothers and babies by eliminating maternal mortality and reducing maternal morbidity. For more on members’ efforts, including case studies, podcasts, webinars and other resources, visit the AHA’s Better Health for Mothers and Babies Initiative webpage.” 
  • The New York Times tells us,
    • “The doctor kept hearing the same story from his patients. After taking GLP-1 weight-loss drugs and finally shedding those excess pounds, some had gone a bit rogue. They began spacing out the shots instead of injecting themselves every week.
    • “And it seemed to be working, said Dr. Mitch Biermann, an obesity and internal medicine specialist at Scripps Clinic in San Diego.
    • “By the time the third person told me they were taking it every second or third week and still maintaining their weight, I started recommending it to other patients,” he said.
    • “Dr. Biermann also conceived a study to test the strategy. Now the results of that research are in: After 36 weeks of follow-up, most of the patients who spaced out their GLP-1 injections kept the weight off and also maintained health benefits like reduced blood pressure and better blood sugar control.
    • “Only four patients gained weight after making the switch, and they quickly reverted back to weekly injections, the report said.
    • “The study was small, only 34 patients in a relatively homogeneous group — mostly white and privately uninsured. And it was done by analyzing their existing medical charts.
    • “Still, the research, published in February in the journal Obesity, provides a potentially appealing new option for patients who are loath to commit to lifelong weekly injections of a costly medication that may not be covered by insurance and that some fear could have unknown side effects.”
  • Medscape informs us,
    • “Viral and bacterial infections’ overlapping symptoms and signs can complicate RSV diagnosis and lead to unnecessary antibiotic prescriptions.
    • “In this study, children who had RSV detected via a rapid antigen test had a 48% lower likelihood of receiving antibiotics within 14 days of diagnosis.
    • ‘Overall, 20% of the kids who tested positive for RSV received at least one antibiotic prescription compared with 40% of those testing negative.”
  • and
    • “Alzheimer’s brain changes progressed up to 20 times faster in women with Alzheimer’s and alpha-synuclein co-pathology compared with men, a cohort study showed.” * * *
    • “The findings suggest that when alpha-synuclein — a protein associated with Parkinson’s and other Lewy body diseases — accumulates alongside Alzheimer’s pathology, it may drive faster Alzheimer’s progression in women.”
  • Health Day points out,
    • “A frequently prescribed atrial fibrillation drug might interact with blood thinners
    • “Diltiazem had a higher rate of serious bleeding events when taken with blood thinners like apixaban or rivaroxaban
    • “Diltiazem interacts with enzymes that play a role in the metabolism of the blood thinners.”
  • Per an NIH news release,
    • “A research team funded by the National Institutes of Health (NIH) has developed a versatile machine learning model that could one day greatly expand what medical scans can tell us about disease. Scientists used their tool, named Merlin, to assess 3D abdominal computed tomography (CT) scans, accomplishing tasks as simple as identifying anatomical features to as complex as predicting disease onset years in advance. Despite being developed as a general-purpose CT model, Merlin surpassed a gauntlet of similar automated tools in tasks they were specifically built to handle.
    • “The team trained their model on a unique set of patient CT scans linked to radiology reports and medical diagnosis codes collected from the Stanford University School of Medicine. The researchers note that it is the largest collection of abdominal CT data to date.  
    • “Rich datasets like this are necessary to push the limits of what artificial intelligence models can accomplish in medicine,” said Bruce Tromberg, Ph.D., director of NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). “This work exemplifies how meticulously crafted training data can enable remarkable insights that significantly streamline workflows and assist in clinical decision-making.” 
  • Genetic Engineering and BioTechnology News adds,
    • “Life is governed by tiers of gene regulation, driven by modulation of RNA polymerase (RNAP) by transcription factors. The second tier is composed of cell signaling cascades and feedback loops. Dissecting gene regulation requires distinguishing transcription factor targets from indirect network effects. 
    • “A new study by The Rockefeller University published in Molecular Cell titled, “Cell-free genomics reveals fundamental regulatory principles of the Mycobacterium tuberculosis transcription cycle,” has revealed fundamental features of the transcription cycle in the bacteria that causes tuberculosis. The study informs the development of new drugs.
    • “Gaining a deep understanding of how transcription works reveals central principles in biology that have huge significance for human health,” said Elizabeth Campbell, PhD, head of the Laboratory of Molecular Pathogenesis at The Rockefeller and corresponding author of the paper. “We can more precisely design therapeutics to target a process if we truly understand it.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “In recent months, payers across the country have tried tightening policies to get a better grip on evaluation/management coding.
    • “While payers often say the policies aim to control costs or combat fraud, these more restrictive policies are often met with provider backlash. [You will find in the article] three insurer policies from the past few months — and where they stand.
  • Fierce Healthcare relates,
    • “Even as its inpatient occupancy surged near the end of 2025, the nation’s largest for-profit hospital system said it has generally managed to avoid revenue-limiting capacity constraints and should continue to do so through 2026 even as its volumes grow. 
    • “HCA Healthcare, with its stock sitting at an all-time pricing high, pleased investors earlier this year when announcing a better-than-expected fourth-quarter performance and bullish 2026 guidance despite hundreds of millions in expected headwinds due to changes in Medicaid policy. 
    • “But, while that quarter’s same-facility equivalent admissions rose 2.5% over the prior year, in line with expectations, its inpatient surgeries remained flat while its outpatient surgical volume dipped by about 1.5%. At the same time, its hospitals were filled to about 73% to 74% capacity, a historical high point that could place strains on the operating efficiency of hospitals pulling the average upward.”
  • Beckers Hospital Review tells us,
    • “Grand Forks, N.D.-based Altru has acquired CHI St. Alexius Health Devils Lake (N.D.) — a 25-bed critical access hospital — from Chicago-based CommonSpirit. The hospital is now known as Altru Hospital Devils Lake, according to a March 2 Altru news release. 
    • “This transition represents an opportunity to make a meaningful difference in the lives of those we serve,” Altru CEO Todd Forkel said in the release. “Over the next several months, we will be expanding services and enhancing care offerings to better meet the needs of this important community.” 
    • “Altru is also in the process of acquiring three more hospitals from CommonSpirit. In January, Altru signed a nonbinding agreement to acquire CHI St. Alexius Health in Bismarck, CHI St. Alexius Health Turtle Lake and CHI St. Alexius Health Garrison (N.D.). If finalized, the move would expand Altru’s footprint further west in North Dakota.
    • “CommonSpirit is also in talks with Pittsburgh-based UPMC to sell Trinity Health System — a three-hospital network based in Steubenville, Ohio. CommonSpirit CFO Michael Browning said on the system’s March 2 investor call that both deals, if approved, could close in 2026.”
  • and
    • “Academic health systems posted a wide range of operating performance in 2025 and early fiscal 2026, with margins spanning from negative territory to double digits. While strong investment returns buoyed bottom lines at many organizations, core operations remain under strain from rising labor, supply and drug costs.
    • “Across these systems, operating margins spanned from -2.6% to 10.7%, highlighting the uneven financial recovery taking shape in academic healthcare. Many organizations saw stronger net income driven by investment returns and nonoperating gains, even as core operating performance remained thin. Expense growth — particularly labor, supplies and drug costs — continues to pressure margins, while scale, integration and restructuring efforts are increasingly shaping financial trajectories across academic healthcare.
    • “{The article shows] how 12 major academic and nonprofit systems stack up based on their most recent financial reports. 
  • Health Day informs us,
    • “Telemedicine appointments aren’t only more convenient, but actually save money for both patients and health care systems, a new study says.
    • “Telemedicine visits are five times less costly than in-person appointments for the most common conditions, researchers recently reported in JAMA Network Open.
    • “On average, telemedicine patients are billed $400 less, researchers found, and are less likely to need follow-up visits after their first appointment.
    • “Before we did this study, there was a common concern that telemedicine might serve only as an easy source of ‘first aid,’ just delaying in-person care and increasing costs overall,” said co-senior researcher Dr. David Asch, senior vice president for strategic initiatives at the University of Pennsylvania.
    • “But we found that wasn’t true, and our work suggests that for many patients, telemedicine can be a complete solution, not just a temporary band-aid,” he said in a news release.”
  • Per Fierce Pharma,
    • “The primary growth drivers in Bayer’s pharma sector—Nubeqa and Kerendia—are performing even better than the company anticipated and their momentum is expected to continue in 2026. But that won’t lead to growth of Bayer’s pharma business overall this year as two contraction drivers—Xarelto and Eylea—are working in the opposite direction. 
    • “This will be the last year of the sector’s “resilience phase,” Bayer’s pharma president Stefan Oelrich said during a quarterly conference call, which will set it up for growth in 2027.”
    • “In a way, Bayer’s pharma business is the company in a microcosm. As the German conglomerate absorbs massive litigation charges related to its disastrous acquisition of Monsanto a decade ago and eyes a potential $7.25 billion settlement of Roundup lawsuits, a rebound is finally in sight.”
  • Per Fierce Healthcare,
    • “Eldercare company Papa is rolling out a new program that leans on its existing companion care services to support quality improvements for health plans.
    • “Called Papa Plus, the company’s network of vetted “Pals” will be able to provide key services that insurers need in addition to their work in addressing social needs of members. These tasks could include assisting a member in scheduling a key wellness visit and then accompanying them to the appointment, providing support after hospital discharge or helping an individual use a telehealth visit.
    • “This builds a direct engagement channel to some of the most vulnerable—and least reachable—patients, Papa said in the announcement, which was shared exclusively with Fierce Healthcare.”