Thursday report

Congress

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.”

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.

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.”

Tuesday report

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the judicial front,

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

From the public health and medical / Rx research front,

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

From the U.S. healthcare business front,

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

Monday report

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Republicans are renewing their push to fully fund and reopen the Homeland Security Department, suggesting the war the United States launched against Iran over the weekend has heightened the need to end the single-agency shutdown that entered its third week on Monday. 
    • “House Republicans will bring up another vote on a DHS appropriations bill this week, Majority Leader Steve Scalise, R-La., announced, saying it was dangerous for Democrats to continue holding up the funding due to concerns over the Trump administration’s immigration enforcement crackdown. 
    • “The legislation would “end the DHS shutdown so we can ensure agencies can protect America during this dangerous time,” Scalise said, noting the FBI has warned of an elevated threat of terrorist activity domestically.” * * *
    • “Most of the department’s employees have continued to work during the shutdown, with only about 8% of the workforce home on furlough. Many employees, such as law enforcement and other personnel at Immigration and Customs Enforcement and Customs and Border Protection, are receiving their normal paychecks thanks to funding Congress provided in the One Big Beautiful Bill Act. Others, such as Transportation Security Administration and Federal Emergency Management Agency workers, have started to receive partial paychecks or will do so this week. The U.S. Coast Guard is paying its uniformed personnel on time, but civilians will face delayed pay.” 
  • Healthcare Dive relates,
    • “The American Medical Association is overhauling how U.S. doctors report and bill for pregnancy services, bulldozing the current system of bundled payments and replacing it with more granular, itemized codes next year.
    • “The changes, shared exclusively with Healthcare Dive, could help improve poor maternity health outcomes in the U.S. But it’s also an acquiescence to specialty groups, which have long lobbied the powerful medical association that modern obstetric services are more complex than the current coding system is able to reflect.
    • “The move also represents a step back for value-based care, and could incentivize OB-GYNs and other doctors to provide unnecessary medical services at a time of skyrocketing health spending.
    • “But the changes shouldn’t result in OBGYNs, nurse-midwives or other maternity care specialists bringing in more revenue, according to the AMA, which argues the new coding system will benefit the entire healthcare industry.” * * *
    • “Global codes are normally billed when a baby is delivered, which can keep insurers in the dark about their members’ pregnancies. The new codes should give insurers more information, including when a member gets pregnant, that could help them ensure expecting mothers get adequate prenatal care, or know if mothers had complications during delivery that could necessitate follow-up services, according to Dr. Daniel Halevy, an executive at New York nonprofit insurer Healthfirst.”
  • and
    • “Sweeping reforms in the Consolidated Appropriations Act of 2026, signed into law by President Donald Trump earlier this month, included changes that could upend the traditional PBM model, while also turning attention back to drugmakers.” * * *
    • “With PBMs’ bargaining power facing stricter limits under the new reform [which takes effect later this decade to allow for necessary rulemaking], questions surrounding pricing could shift in a new direction.
    • “Be ready for the spotlight to swing back to drug manufacturers,” said Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department and head of its pharmacy practice group.
    • “As PBMs lose traction in the coming years, the pressure on drugmakers to justify their own list prices could intensify.
    • “Now, the argument is going to be that PBMs have been handcuffed, limiting their ability to use some of these abusive tools,” Dresser suggested. “So, it’s going to be up to the drug manufacturers to make sure they’re taking the appropriate steps and not continuing in the old paradigm now that there should be a shift in financial incentives.”
  • Bloomberg Law reports,
    • “A group representing thousands of pharmacies across the US said its members are experiencing financial issues after the rollout of the government’s drug price negotiation program, urging the Centers for Medicare & Medicaid Services to immediately address cash flow concerns.
    • “A letter from the National Community Pharmacists Association is asking CMS Administrator Mehmet Oz to ensure pharmacies receive timely payments under the Medicare Drug Price Negotiation Program, finding in a survey that its members are facing cash flow issues after dispensing certain drugs and waiting for a refund from the manufacturer. 
    • “We need CMS to take all necessary steps to expedite the manufacturers’” refund payments to pharmacies, Ronna Hauser, senior vice president of policy and pharmacy affairs for NCPA, said in the letter to the CMS sent Thursday. “Pharmacies cannot continue to dispense these drugs with delayed payments unless the cash flow issues significantly improve.”
  • Per an Employee Benefits Research Institute news release,
    • “Rising health care costs are affecting household finances for many privately insured adults, with 4 in 10 reporting higher expenses in the past year and many cutting discretionary spending or reducing retirement contributions, according to results from the 2025 EBRI/Greenwald Research Consumer Engagement in Health Care Survey (CEHCS) released today by the Employee Benefit Research Institute (EBRI).
    • “Employment-based coverage remained the dominant source of private insurance, with 6 in 10 covered through their own job. Deductibles also remained widespread across plan types: More than three-quarters of enrollees had a medical deductible, including 70% of traditional plan enrollees. Enrollment in high-deductible health plans dipped slightly in 2025, while enrollment in consumer-directed health plans and health savings accounts (HSAs) appeared relatively stable.
    • “The annual survey also found that most enrollees spent relatively little time selecting coverage during open enrollment, with about half spending less than an hour reviewing options and most spending under two hours. While most adults reported being satisfied with the ease of plan selection and the information available, satisfaction with the availability of affordable plan options and the number of plans to choose from declined in 2025.”
  • Beckers Payer Issues tells us,
    • “CMS is sanctioning Elevance Health and plans to suspend enrollment into the insurer’s Medicare Advantage prescription drug plans, according to a Feb. 27 agency letter.
    • ‘The enrollment and communications pause is set to begin March 31 unless Elevance submits all data corrections and an attestation in advance. CMS said the intermediate sanctions stem from “substantial and persistent noncompliance with Medicare Advantage risk adjustment data submission requirements.” The sanctions will apply until Elevance resolves the issues.”
  • Per a Labor Department news release,
    • “The U.S. Department of Labor’s Wage and Hour Division announced [February 26] a proposed rule designed to help workers and employers better understand how to determine when a worker is an employee and when the worker may be classified as an independent contractor under the Fair Labor Standards Act and related federal laws. 
    • The proposed rule would rescind the department’s 2024 final rule addressing the classification of independent contractors and replace it with an analysis for employee classification similar to the one adopted by the department in 2021. Consistent with Supreme Court and federal circuit court precedent, the proposed rule would make it easier to properly differentiate between employees with the protections under the Fair Labor Standards Act and those workers who work as independent contractors.” * * *
    • “The department encourages all interested parties to submit comments on the proposed rule, which has a 60-day comment period that closes at 11:59 p.m. ET on April 28, 2026.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it’s developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. 
    • “The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin.”
  • MedTech Dive relates,
    • “Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday.
    • “The Food and Drug Administration awarded approval to CardioMEMS Hero, a new version of the device that patients use to take daily pulmonary artery pressure readings.
    • “Abbott has made Hero smaller and 60% lighter than the previous reader, fitting the electronics into a device the size of a laptop case to make it easier to use and take on planes.”
  • and
    • “Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
    • “Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis.  “Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
    • “The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.”

From the judicial front,

  • Bloomberg Law reports,
    • “The Justice Department said it won’t appeal the decision of a New York federal judge to throw out a murder charge against Luigi Mangione, which means he won’t face the death penalty if he’s convicted of killing UnitedHealth Group Inc. executive Brian Thompson.
    • “US District Judge Margaret Garnett ruled in January that prosecutors can’t pursuethe capital murder charge, but that a jury could determine if Mangione caused Thompson’s death under two federal stalking laws. If convicted of those crimes, he could face life in prison without possibility of parole. 
    • “In a one-page letter Friday to Garnett, a Justice Department lawyer said prosecutors won’t challenge the judge’s decision.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “A report published March 2 by the American Cancer Society found that colorectal cancer rates among adults 65 and older continue to decline while rates for younger adults continue to increase. The study found that the increase is being driven by a higher prevalence of rectal cancer, which now makes up 32% of all colorectal cancer diagnoses, up from 27% in the mid-2000s. The study also projects 158,850 new cases of colorectal cancer in the U.S. in 2026, and that 55,230 individuals will die from the disease. Nearly one-third of deaths are estimated to be younger than age 65.” 
  • Cardiovascular Business tells us,
    • “Patients with type 2 diabetes who use GLP-1 receptor agonists (GLP-1 RAs) and make healthy lifestyle choices can significantly lower their risk of experiencing a heart attack or stroke, according to new data published in The Lancet Diabetes & Endocrinology.[1]
    • The study’s authors explored data from more than 98,000 participants from the U.S. Department of Veterans Affairs’ Million Veteran Program. These individuals were enrolled from 2011 to 2023. 
    • “Lifestyle habits explored in this analysis included getting a recommended amount of exercise, not smoking, sleeping well, drinking minimal alcohol, properly managing stress, connecting with others socially and avoiding opioids. Overall, adults on a GLP-1 RA and following six to eight of these healthy habits was associated with a 43% lower risk of experiencing a major adverse cardiovascular event (MACE) than those not taking GLP-1 RA or adhering to these habits. When adults followed all eight habits, meanwhile, the risk was approximately 60% lower.
    • “In addition, those using a GLP-1 RA had a 16% lower MACE risk than those who did not use a GLP-1. 
    • “Our findings underscore that, even in the era of highly effective GLP-1 pharmacotherapy, lifestyle habits remain central to diabetes management and cardiovascular risk reduction and can substantially amplify the benefits of modern medications,” corresponding author Frank Hu, MD, PhD, chair of the department of nutrition at the Harvard T.H. Chan School of Public Health, said in a statement.”
  • Contemporary OB/GYN informs us,
    • “The quadrivalent HPV vaccine is associated with a significantly reduced risk of invasive cervical cancer that persists for at least 18 years after administration.
    • “Vaccination before the age of 17 provides a 79% lower risk of cervical cancer, while those vaccinated at age 17 or older also experience significant long term risk reductions.
    • “Population level data shows that school based vaccination cohorts have significantly lower rates of invasive cervical cancer compared to earlier opportunistic vaccination cohorts.”
  • MedPage Today points out,
    • “The location and amount of brain microbleeds that a person has could be telling of their risk of dementia, according to an observational analysis.
    • “Compared with controls with no cerebral microbleeds detected on MRI, there was an increased dementia risk in older people with:
      • “Mixed subcortical and lobar microbleeds (HR 1.99, 95% CI 1.40-2.83)
      • “Lobar-only microbleeds, with or without cortical superficial siderosis (HR 1.96, 95% CI 1.30-2.97)
      • “Any cortical superficial siderosis (HR 2.57, 95% CI 1.36-4.89)
    • “Participants with three or more cerebral microbleeds of any pattern also had an increased risk of dementia (HR 1.92, 95% CI 1.35-2.72), as did peers with at least two subcortical microbleeds, according to Rebecca Gottesman, MD, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, and colleagues.
    • “Their report, based on the Atherosclerosis Risk in Communities-Neurocognitive Study, was published in Stroke.
  • and
    • “Chronic migraine patients who used GLP-1 receptor agonists to treat conditions like obesity or diabetes had fewer emergency department (ED) visits than those on topiramate (Topamax), a real-world data analysis showed.
    • “Compared with topiramate users, GLP-1 drug initiators were 10% less likely to visit the ED over the following year (RR 0.90, 95% CI 0.86-0.94), reported Hsiangkuo Yuan, MD, PhD, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia, in an abstract released ahead of the American Academy of Neurologyopens in a new tab or window annual meeting.”
  • The Wall Street Journal asks whether Multi-Cancer Blood Tests Are Ready for Prime Time?
    • Early detection tests are already on the market, but without FDA approval or proof they reduce deaths some doctors urge caution
  • Per BioPharma Dive,
    • “Roche’s experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofi’s Aubagio, the company said Monday.
    • “However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drug’s approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion, for fenebrutinib, Leuchten wrote.
    • “Fenebrutinib is part of a new crop of “BTK inhibitors” that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given up on prospective drugs.”

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “UnitedHealth Group has named Dennis Stankiewicz as chief accounting officer, effective March 2. 
    • “Tom Roos, who has served as CAO since 2015, has been named CFO at Optum Insight, the company said in regulatory filings.”
  • Healthcare Dive adds,
    • “UnitedHealth executive and former Optum leader Heather Cianfrocco is leaving the company, according to a post on LinkedIn.
    • “Cianfrocco was promoted to executive vice president of governance, compliance and information security at UnitedHealth in May, after serving for a year as CEO of Optum, the company’s health services arm. Patrick Conway, the former CEO of Optum Rx, replaced Cianfrocco.
    • “Cianfrocco is departing UnitedHealth after serving in a number of executive positions, including as CEO of Optum Rx and chief of UnitedHealthcare’s community and state division. “After 24 years, I am saying goodbye to the team at UnitedHealth Group,” she said in a post on LinkedIn. “I am leaving with so much pride in what we have accomplished together.”
  • Beckers Hospital Review notes,
    • “According to data gathered by Becker’s, Parkland Health and Hospital System [in Dallas, Texas] saw the highest number of emergency department visits in 2025. 
    • “The figures [shown in the article] represent the number of ED visits at individual hospital facilities, rather than the total visits across entire health systems. These self-reported totals were provided directly by hospitals.
  • Fierce Healthcare relates,
    • “Healthcare technology companies DoseSpot and Arrive Health have merged to combine an electronic prescribing platform with medical and pharmacy benefits data to advance real-time medication price transparency for providers and patients.
    • “The new company, called Interra Health, combines Arrive Health’s coverage and pricing network with DoseSpot’s e-prescribing capabilities to support prescribing decisions and help patients access the right medication at the lowest cost, according to the companies.
    • “Bain Capital Tech Opportunities is backing the deal and will serve as majority owner. PSG, the former majority owner of DoseSpot, will be a minority owner. Additional minority investors include Providence and UPMC Enterprises.
    • “The combined company is profitable, growing at approximately 40% annually and projected to exceed $100 million in revenue in 2026, executives said.”
  • Per BioPharma Dive,
    • “Privately held Candid Therapeutics will merge with Rallybio in a deal to take the inflammatory disease drugmaker public, the companies said Monday.
    • “The new entity will operate under Candid’s name, and trade on Wall Street under the ticker “CDRX.” As part of the deal, Candid raised $505 million from more than a dozen venture capital firms and mutual funds including Venrock, RA Capital Management and Janus Henderson Investors.
    • “Candid is developing bispecific antibodies known as T-cell engagers it acquired in two deals with Chinese biotechnology firms in 2024. One of Candid’s central goals is to show it can advance drugs that are similar to cell therapies targeting B cells, but easier to manufacture and administer. While bispecifics research has largely focused on cancer, startups like Candid — and even some pharmas — are now testing the applicability of these drugs against autoimmune conditions.”

Weekend update

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

From Washington, DC,

  • Roll Call previews Congress’s agenda for this week here.
  • Of note,
    • Senate Committee on Health, Education, Labor, and Pensions
    • 10:00 AM (EST) – Senate | 430 Dirksen Senate Office Building, Washington, D.C.
    • Meeting: Hearings to examine transforming health care with data, focusing on improving patient outcomes through next-generation care.
    • Meeting Details
  • Per a February 27, 2026, HHS news release,
    • The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) today announced the appointment of two new members to the CDC Advisory Committee on Immunization Practices (ACIP).
    • The two new members are:
      • Sean G. Downing, M.D., physician specializing in Internal Medicine and Pediatrics, and
      • Angelina Farella, M.D., pediatrician and owner of A Brighter Tomorrow Family Health and Wellness in Webster, Texas.

From the judicial front,

  • Per a February 27, 2026, Justice Department news release,
    • “Atlanta Gastroenterology Associates located in Atlanta, Georgia, has agreed to pay $4.75 million to resolve allegations that it violated the False Claims Act by receiving kickbacks in exchange for referrals of gastrointestinal pathology services and by performing certain gastrointestinal pathology services that were not medically reasonable or necessary.
    • “The United States alleged that beginning in approximately May 2017, Atlanta Gastroenterology Associates contracted with Advanced Pathology Solutions (APS), a pathology laboratory located in Little Rock, Arkansas, to construct and operate a limited-capacity pathology laboratory in Atlanta Gastroenterology Associates’ office. Atlanta Gastroenterology Associates received various benefits from APS in connection with the setup and ongoing operations of the in-house lab, in which histology technicians prepared and stained specimen sample slides and Atlanta Gastroenterology Associates billed Medicare and other insurers for the technical component of those services. In exchange, Atlanta Gastroenterology Associates agreed to exclusively refer patients to APS, which interpreted the slides and billed for the professional component of the services. The United States alleges that the benefits provided by APS to Atlanta Gastroenterology Associates were unlawful remuneration in exchange for patient referrals.” * * *
    • The claims resolved by the settlement are allegations only and there has been no determination of liability.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “Some Great Value cottage cheese products sold at Walmart are being recalled because they may not have been fully pasteurized, Saputo Cheese USA said.
    • “The recall affects select cottage cheese products made between Feb. 17 and 20, and sold in the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Missouri, Mississippi, Montana, New Mexico, Nevada, Oregon, Texas, Tennessee, Utah, Washington and Wyoming, the U.S. Food and Drug Administration (FDA) reported.
    • “No illnesses or hospitalizations have been reported so far.
  • Medscape tells us,
    • “Age-adjusted rates of cardiovascular disease (CVD) mortality tripled from 3.4 to 10.34 per 100,000 people between 1999 and 2023 among US adults with obesity, with higher rates observed in men, older adults, non-Hispanic Black adults, and in the South.”
  • and
    • “Most Americans with obesity perceive themselves as only having overweight regardless of race or ethnicity, whereas experiences of weight stigma and bias differ across White, Black, and Hispanic groups with obesity, new research found.
    • “Clinicians need to know their patients, understand them from a cultural and racial perspective, and tailor treatment plans to align with their expectations and needs. This will improve motivation, engagement, and adherence,” study author Rodolfo J. Galindo, MD, Director of the Comprehensive Diabetes Center, Lennar Medical Center, University of Miami Health System, told Medscape Medical News.
    • “Obesity medicine physician scientist Fatima Cody Stanford, MD, Massachusetts General Hospital and Harvard Medical School, Boston, told Medscape Medical News that the new findings add “an important, clinically relevant nuance that weight stigma is not monolithic and that experiences and attitudes can differ meaningfully across racial/ethnic groups among adults living with obesity.”
  • The American Medical Association lets us know what doctors wish patients knew about social isolation.
  • Medscape informs us,
    • “Can agnostic therapies revolutionize precision oncology? Are we ready to treat cancer without looking at the organ? For decades, cancer has been told as a story of organs: lungs, breast, colon, etc. Each diagnosis implied a predictable therapeutic path. In recent years that map has begun to blur, and in oncology clinics it is increasingly common for specialists to focus less on the patient’s cancer type and more on the molecular alteration driving its growth. The idea is to concentrate on the molecular footprint rather than the organ — a shift that is transforming precision oncology.”
  • and
    • “Described for the first time in the 1940s, lipedema has long been misunderstood, often mistaken for common obesity or lymphedema and frequently treated as a cosmetic issue. This has produced chronic underdiagnosis, stigma, and fragmented care.
    • “But that picture has changed structurally with the recent publication of the Lipedema World Alliance’s first international consensus on the definition and management of lipedema, based on the Delphi method.
    • “Specialists from 19 countries contributed 59 consensus statements covering definition, pathophysiology, diagnosis, impact on quality of life, therapeutic strategies, and future research directions. Rather than offering definitive solutions, the document provides a shared starting point for clinicians, researchers, and policymakers.”
  • Fierce Pharma points out,
    • “The treatment landscape for clear cell renal cell carcinoma (ccRCC) could be due for a shake-up following dual breakthroughs from Merck’s Litespark clinical trial program for Welireg. Data being presented at the 2026 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium suggest that adding Welireg to other existing drugs significantly improves outcomes for patients at two distinct stages of their cancer journeys.
    • “For advanced ccRCC patients whose cancer has recurred following previous immunotherapy, a combination of Welireg (belzutifan) and Merck’s Eisai-partnered Lenvima (lenvatinib) significantly reduced patients’ risk of disease progression or death by 30% compared with Exelixis’ Cabometyx (cabozantinib), according to results from the Litespark-011 trial.
    • “Separately, in patients with resected ccRCC at an increased risk of recurrence following surgery, by adding Welireg to Merck’s standard Keytruda, investigators achieved a 28% reduction in the risk of the patients’ cancer returning, according to data from the Litespark-022 study.”

From the U.S. healthcare business front,

  • The Healthcare Cost Institute reports,
    • “Hospital outpatient care is a large and growing component of the health care spending equation among ESI [employer sponsored insurance] enrollees. There is a disconnect between the most common reasons for hospital outpatient visits and the drivers of spending. Diagnostic tests, imaging, and evaluation and management visits accounted for more than 75% of visits in 2022, but these three categories represented just 39% of spending, which was largely driven by imaging procedures. Meanwhile, major surgeries and minor procedures accounted for 34% of spending despite being only 8% of visits.
    • “Site neutral payment policies are one approach to curbing the growth of hospital outpatient spending. These policies require providers to charge the same amount for a service regardless of whether it was performed in a hospital outpatient department or a less intensive setting like a doctor’s office. Site neutral payments could reduce the amount of money spent on imaging and evaluation and management visits, but may not be appropriate for major surgeries like joint replacement.
    • “Hospital outpatient services are also nearly three times more expensive in ESI than in Medicare. Policies that aim to align Medicare and ESI payments for outpatient care may be more suited to addressing the drivers of cost like outpatient surgery and other higher intensity procedures. Payment parity policies can also impact lower-cost, high-volume services like mammography and diagnostic testing. Effective approaches to addressing outpatient hospital costs will require creativity and a blended approach that accounts for the wide spectrum of care delivered in this setting.”
  • Healthcare Dive relates,
    • “For-profit hospital operator Universal Health Services expects to increase admissions and hit long-standing growth targets in its behavioral health unit this year, executives said on a fourth-quarter earnings call Thursday.
    • “Executives said 2026 would be the year its behavioral health unit achieved 2% to 3% growth in adjusted patient days — a number the system has struggled to hit as it tries to address lagging growth at its behavioral facilities. The system initially expected to hit that target last year, but deferred due to challenges with labor and staffing.
    • “Still, executives said they anticipate multiple headwinds this year, including losses from the lapse of more generous subsidies in Affordable Care Act plans and a new staffing law in California.”
  • BioPharma Dive tells us,
    • “UniQure lost nearly half a billion dollars in market value Thursday, as comments made by the head of the Food and Drug Administration appeared to stoke investor fears that the company’s most advanced research project won’t be approved in the U.S.
    • “Shares of UniQure dropped more than 30% shortly after FDA Commissioner Martin Makary appeared on CNBC to defend the agency’s approach to approving rare disease therapies. The agency has come under fire for multiple delays and regulatory setbacks involving these medications. Makary, though, said critics have been searching for a “boogeyman” to blame for recent rejections, when the bottom line is that some of these therapies just haven’t been proven effective.
    • “He mentioned, as one example, how the FDA was pressured to approve a product that’s injected into the space surrounding the brain, through a burr hole drilled into patients’ skulls.
    • “Makary didn’t name any company, but that didn’t stop some investors from interpreting his remarks as a reference to UniQure’s “AMT-130,” a gene therapy for Huntington’s disease administered via burr hole.
    • “Wall Street analysts noted that Makary might not have been talking about UniQure * * *.
    • In any case, what’s notable from Makary’s appearance is his “steadfast defense” of the FDA, “which is discouraging for those hoping that the agency can be convinced to reconsider recent negative decisions, in the absence of specific political pressure,” wrote Paul Matteis, of Stifel, in a note to clients.
  • MedTech Dive informs us,
    • GE HealthCare has struck a 10-year deal with UCSF Health to support imaging at the healthcare system, the company said Thursday.
    • UCSF Health will work with GE HealthCare to implement remote scanning capabilities, train staff and improve magnetic resonance imaging performance. 
    • The agreement is part of a series of large deals involving GE HealthCare. CEO Peter Arduini told investors last month that the company has inked enterprise deals worth $7 billion in three years.

Midweek report

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

From Washington, DC,

  • Healthcare Dive reports,
    • “America has entered its “golden age,” President Donald Trump argued in a lengthy State of the Union address Tuesday night that glossed over the biggest achievements of the president’s second term so far but was notably light on healthcare.
    • “The economy is improving, prices are coming down, illegal immigration is under control and crime is plummeting, the president said, while lauding guests in attendance like Erika Kirk and the Olympic gold medal-winning U.S. men’s hockey team. Trump’s remarks — the longest State of the Union speech in recorded history, at an hour and 47 minutes — were often met with chants of “U.S.A! U.S.A!” from Republicans in the gallery, and come as the president seeks to reverse plummeting approval ratings.
    • “However, Trump didn’t use the State of the Union to introduce many new policy ideas. He also didn’t devote much time to healthcare, spending only about five minutes of his speech on the sector.”
  • Per an HHS news release,
    • “Today at the White House, Vice President J.D. Vance, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., and Administrator of the Centers for Medicare & Medicaid Services (CMS) Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5 million of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars.”
    • * * * “CMS is looking to stakeholders to provide input, based on their experience and knowledge, on additional ways the agency can tackle fraud prevention to help inform the development of a possible future rule under CMS’ Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The CRUSH request for information (RFI) seeks input from a broad range of stakeholders – including states, providers, suppliers, payers, technology companies, patient advocates, beneficiaries, and others – on ways to strengthen CMS’ ability to prevent, detect, and respond to fraud, waste, and abuse, and program inefficiencies in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.” * * * 
    • “Comments on the CRUSH Request for Information must be submitted by March 20, 2026, via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03968/request-for-information-comprehensive-regulations-to-uncover-suspicious-healthcare (refer to CMS-6098-NC).
    • “More information on CMS’ fraud prevention efforts is available at: www.cms.gov/fraud.”
  • Govexec offers five things to watch concerning the Department of Homeland Security shutdown.
  • The Wall Street Journal relates,
    • “President Trump’s nominee for surgeon general aligned herself with the administration’s moves on vaccines so far, including shrinking the number of recommended vaccines for children, as she told lawmakers in her confirmation hearing that her focus is fighting chronic disease. 
    • “Dr. Casey Means told the Senate health committee on Wednesday that she believes vaccines save lives but declined to promise recommending measles and flu shots for children. 
    • “I’m not an individual’s doctor, and every individual needs to talk to their doctor before putting medication in their body,” Means said, in response to a question about whether she would recommend other mothers get measles vaccines for their children.” 
  • Per an OPM news release,
    • “The US Office of Personnel Management today issued a memorandum to federal agencies providing updated guidance ending use of the Administrative Careers with America (ACWA) assessment. This step reinforces the administration’s ongoing efforts to streamline hiring and ensure agencies recruit the most qualified applicants based on merit.
    • “From the beginning, ACWA (which was developed in response to the Luevano consent decree) was criticized by hiring managers and applicants alike as ineffective in identifying quality candidates for federal service. In light of OPM’s development of validated, state-of-the-art assessment tools (particularly the USA Hire platform), there is no longer a need for ACWA.”
    • * * * “Read the memo here and Director Kupor’s blog on this here.”
  • Govexec also explains why “Why your federal benefits may not protect your family the way you think.”
    • “While federal employee benefits can assist beneficiaries in the event of a loved one’s death, it’s important to understand the rules of those plans and how to best seamlessly apply them to your survivors.”
  • The American Hospital Association (AHA) News tells us,
    • “The Health Resources and Services Administration Feb. 25 said it will extend the deadline to April 20 to receive comments on its request for information on whether to implement a 340B rebate model program. Comments on the RFI were originally due March 19. The AHA, joined by several other national groups representing 340B hospitals, last week urged HRSA to extend the original deadline to allow stakeholders to provide feedback to HRSA’s detailed questions in the RFI.  
    • “HRSA also indicated that it may expand the 340B rebate model pilot program to all drugs included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program through 2027.”   
  • Per a Federal Register notice,
    • The Centers for Disease Control announced a meeting of its Advisory Committee on Immunization Practices.
    • “The meeting will be held on March 18, 2026, from 8 a.m. to 5 p.m., EST, and March 19, 2025, from 8 a.m. to 5 p.m., EST, (times subject to change; see the ACIP website for updates: https://www.cdc.gov/vaccines/acip/index.html). The meeting is expected to be held at the Centers for Disease Control and Prevention, with virtual option. Written comments must be received between March 2 – 12, 2026.”
  • Mercer lets us know,
    • “Mercer projects the 2027 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted-benefit health reimbursement arrangements (HRAs) will increase from 2026 levels. These unofficial 2027 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2026, and Mercer’s projected C-CPI-U values for February and March.
    • ‘The table [in the article] shows the projected HSA, HDHP, and excepted-benefit HRA amounts for 2027, along with the 2026 and 2025 values for comparison. The HSA catch-up contribution limit is set by statute and hasn’t changed since 2009.
  • The Government Accountability Office notes,
    • “Mental health, suicide, and substance misuse issues have increased in the U.S. The federal agency that oversees such issues saw its budget more than double in FY21 due to increased COVID-19 and 988 Lifeline funding. This Q&A examines the use of that funding.
    • “The agency received $8.5 billion for COVID-19. It awarded about $8.3 billion in grants for activities such as community mental health. Recipients spent about $6.9 billion as of July 2025.
    • “The agency got $1.6 billion in FY21-24 for the 988 Lifeline, a call, text, and chat hotline supporting those in crisis. It awarded $1.2 billion to funding recipients, who had spent about $906.3 million.”

From the Food and Drug Administration front,

  • MedPage Today informs us,
    • “Assorted flavors of cream cheese were recalled by Made Fresh Salads due to possible Listeriacontamination, according to an FDA notice.”
  • The FDA issued today an “Early Alert: Heart Pump Purge Cassette Issue from Abiomed.”

From the judicial front,

  • Healthcare Dive reports,
    • “Frustrated by a recent, dramatic overhaul of the U.S. childhood immunization schedule, 15 Democrat-led states have sued the Trump administration in a bid to undo those changes as well as what they alleged to be an “unlawful replacement” of a key vaccine panel. 
    • “The lawsuit, filed by 14 attorneys general and the governor of Pennsylvania [in the U.S. District Court for the Northern District of California], seeks to rescind the new schedule adopted by the Department of Health and Human Services and vacate the committee, known as ACIP, reformed last year by Secretary Robert F. Kennedy Jr. Kennedy, the Centers for Disease Control and Prevention and the agency’s acting director, Jay Bhattacharya, are named as defendants in the suit.” 

From the public health, medical and Rx research front,

  • The AHA News reports,
    • “An American Heart Association study published Feb. 25 found that 6 in 10 U.S. women are projected to develop a form of cardiovascular disease by 2050. The report found a growing prevalence of heart disease, heart failure, atrial fibrillation and stroke and projected increases of conditions leading to cardiovascular disease, such as high blood pressure, obesity and diabetes. Additionally, the study found that nearly 32% of girls age 2-19 may be obese by 2050.”
  • Cardiovascular Business adds,
    • “Metabolic and bariatric surgery (MBS) is associated with better long-term cardiovascular protection than glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with type 2 diabetes and obesity, according to a new meta-analysis. The findings were published in full in Obesity Surgery.”
  • Healio tells us,
    • “Cervical cancer incidence has declined close to 30% among women aged 20 to 31 years since the start of the millennium, but certain states have achieved significantly greater reductions.
    • “Washington, D.C., Rhode Island, Michigan and Hawaii all achieved decreases of more than 50%, but incidence in Vermont, West Virginia, Idaho, Arkansas and Alabama remained unchanged.
    • “Researchers observed an association between increased HPV vaccination rates and faster decline in incidence, as well.
    • “A decline of more than 50% observed in several states within such a relatively short period is rarely seen in cancer epidemiology, making these findings particularly striking,” Chenxi Jiang, MPH, associate scientist in surveillance, prevention and health services research at American Cancer Society, told Healio. “At the same time, they are highly encouraging, demonstrating what is achievable when prevention efforts are effectively implemented.”
  • Cigna Healthcare, writing in LinkedIn, points out
    • “Proactive mental health care helps lower overall medical costs.
    • “Untreated mental illness leads to higher health expenses and lost productivity.
    • “Investing in treatment for depression and anxiety yields a fourfold return.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies five forces reshaping pharmacy economics this year.
  • Fierce Healthcare reports,
    • “There’s been a flurry of recent activity in the direct-to-consumer space as drug costs and spending continue to rise.
    • “It’s with that backdrop that GoodRx announced Tuesday it would launch Employer Direct, a new program that allows employers to offer workers lower costs on branded products, which often carry the highest prices. Through the program, these firms can select branded drugs and subsidize the cost for the cash-pay price available through GoodRx.
    • “Employers in the program can also tap into GoodRx’s telemedicine solutions, which bring together the clinical care with the prescription fulfillment to ensure patients get the drugs they need.”
  • Modern Healthcare adds,
    • “Employers tired of dealing with health insurers now have another option at their disposal: Go through a different intermediary instead.
    • “Third-party vendors such as Lantern, Nomi Health and Transcarent are making a play for the employer market as businesses wage a perpetual struggle to manage rising health benefit costs. These platforms tout savings, flexibility and a seamless experience to enable direct contracting with providers at scale.
    • “Their reach, once limited, is now national and includes all types of medical services. Transcarent has more than 20 million members after it acquired care navigation company Accolade last year. Nomi Health serves 19 million members. Lantern’s specialty care platform has grown from 100,000 members to more than 12 million in the last decade.”
  • Fierce Healthcare notes,
    • “Uber Health is rolling out a new feature that allows patients who are comfortable with its platform to book their own rides.
    • “Uber’s healthcare platform has traditionally been a back-end option for providers and other partners to book rides to and from appointments on the behalf of the patient. Through this approach, Uber supported processes like transportation benefits and discharge planning for its partners.
    • “However, the company heard feedback from clients that the administrative time to do this was not insignificant, and that there were many patients who were familiar enough with Uber to book trips themselves, Cory Warner, global head of growth and operations for Uber Health, told Fierce Healthcare in an interview at ViVE on Tuesday.
    • “We’re really excited, because we’ve been able to advance the technology to meet the needs of some of our customers who’ve been sharing with us that, while we have a lot of folks that may not have a smartphone, we do have a number of patients and members who have the Uber app in their everyday life,” she said.”
  • Fierce Pharma informs us,
    • “Novartis is wasting little time sketching out the radiopharmaceutical details of its $23 billion U.S. investment push. Shortly after announcing a new manufacturing facility for the class of cancer meds in Florida, the pharma giant is revealing its intention to build another site in Texas. 
    • “The forthcoming 46,000-square-foot radioligand therapy (RLT) production plant will be set upin Denton, Texas—part of the greater Dallas-Fort Worth area—and becomes the fifth existing or planned radiopharmaceutical manufacturing site in Novartis’ U.S. network, the company said in a Feb. 25 release. 
    • “Construction is slated to kick off this year, with the site expected to come online in 2028, Novartis said. 
    • “The plant will generate jobs in fields like bioengineering, advanced manufacturing, quality and operations, although Novartis did not specify how many new hires it has planned.” 
  • Per BioPharma Dive,
    • “Novo Nordisk announced Wednesday a collaboration with startup Vivtex that’ll give it access to technologies that could yield new oral biologics for obesity and other metabolic diseases.
    • “The companies did not disclose the amount of guaranteed cash going from Novo to Vivtex in the deal. But the Boston biotechnology startup stands to gain as much as $2.1 billion, as well as sales royalties, if drugs emerging from the alliance progress and are eventually commercialized.”
  • and
    • “GSK is scooping up a promising experimental medicine for a dangerous type of high blood pressure through a $950 million acquisition of private Canadian drugmaker 35Pharma.
    • “The drug, HS235, has already completed Phase 1 testing in healthy volunteers and, according to GSK, should soon enter studies focused on either pulmonary arterial hypertension or a different pulmonary hypertension caused by a certain kind of heart failure. The company added that this medicine has potential to fight cardiovascular disease, deliver metabolic benefits and offer a lower risk of bleeding — a key limitation of current PH treatments.
    • “HS235 is a so-called activin signaling inhibitor, designed to fight the over-proliferation of cells that can thicken blood vessel walls. This drug class has already seen success; Merck & Co. won approval for one member, Winrevair, in 2024, and chalked up sales of more than $1.4 billion from it last year. Merck is looking to expand its usage as well.”
  • Per MedTech Dive,
    • “Quantum Surgical, which specializes in medical robotics for cancer treatment, said Tuesday that it has acquired NeuWave Medical from Johnson & Johnson.
    • “Quantum, based in Montpellier, France, with an office in Miami, said the deal supports its strategy of expanding robot-assisted tumor ablation treatment to reduce cancer mortality.
    • “Last year, J&J informed customers that it planned to discontinue the NeuWave business, before announcing in September that it had received a binding offer from Quantum to buy NeuWave.”