Monday report

NIH

Monday report

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

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “As the Senate speeds toward its upcoming August recess, President Donald Trump is turning up the pressure on Senate Majority Leader John Thune to keep his chamber in session and in Washington instead. 
    • “So far, that’s unlikely.  “You could stay here till Christmas” and the situation wouldn’t change, Thune said. “If I thought there was a path to getting a result, I’m all for it.” 
    • “The president posted to Truth Social on Monday morning that “Thune should not allow the United States Senate to ‘leave town’ until it passes” the SAVE America Act, a GOP-crafted package that would require proof of citizenship to register to vote and photo ID at the polls.
    • “The sweeping bill does not have the 60 votes needed to advance through the Senate — a message the South Dakota Republican leader has reiterated both publicly and privately to the other end of Pennsylvania Avenue.” 
  • Per a U.S. Senate Committee news release,
    • “On Thursday, July 30, the Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on bills to increase Americans’ educational opportunities and give them more tools to secure a strong retirement. The Committee will also vote the nominations for Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services, the Director of the Centers for Disease Control and Prevention, and the Secretary of the U.S. Department of Labor.”
  • Govexec relates,
    • “While lawmakers are debating what an appropriate regulatory framework for artificial intelligence should be, experts who spoke at a panel on Monday noted that federal employees have been using the technology for years to develop all sorts of regulations. 
    • “Cary Coglianese, a regulation professor at the University of Pennsylvania, said that agencies, for example, have been using AI to analyze thousands of public comments that some proposed rules receive. 
    • “Back in the day, contractors would literally photocopy comments, clip them out and sort them in different categories — and do what essentially natural language processing tools can do now so quickly and rather effectively,” he said. 
    • “But as the technology advances, speakers on the panel — which was sponsored by the Coalition for Sensible Safeguards, a left-leaning group of more than 220 regulatory-focused organizations — argued that AI could take over more steps in the rulemaking process, potentially supercharging the Trump administration’s efforts to slash regulations and downsize the federal government.”
  •  FEHBlog observation: The government can use AI for many more tasks, and you don’t have to be left leaning to be concerned about this development.
  • Fierce Healthcare tells us,
    • “A tiny federal agency tasked with protecting the public from injuries caused by lawn mowers and coffeemakers is demanding that some of the nation’s biggest health systems turn over detailed, personally identifiable medical records of all patients who seek help at their emergency rooms.
    • “The Consumer Product Safety Commission, responsible for tracking and issuing recalls of dangerous products sold in the U.S., began discreetly pressuring hospital executives this year to share personally identifiable health data with a private contractor. But hospital lawyers and other industry experts have questioned the agency’s authority to collect, its ability to safeguard such a swath of sensitive information, and whether it has followed the legal process to overhaul its surveillance system.
    • “After KFF Health News asked the CPSC about the new system, the agency announced the program on July 21. Left unmentioned, however, is the alarm it has raised among hospital executives, as well as the nature and extent of the agency’s data demands.”
  • and
    • “A new analysis finds that Medicare Advantage enrollees spend less on average than those in the traditional program, but report similar satisfaction levels.
    • “ATI Advisory conducted the study on behalf of the Better Medicare Alliance, analyzing data from the Medicare Current Beneficiary Survey and Cost Supplement files from 2021 to 2023. The analysis found that MA enrollees spent $2,824, or 36%, less out-of-pocket on average in 2023 compared to those in fee-for-service Medicare.
    • “And the difference in spending has risen over time, with savings 16% higher in 2023 than in 2022, according to the report.
    • “Twelve percent of MA beneficiaries said they faced a significant cost burden, or spent more than 20% of their income on healthcare, compared to 24% of people enrolled in traditional Medicare.”
  • Beckers Payer Issues adds,
    • Medicare Advantage will account for 57% of overall Medicare enrollment by 2036, up from 51% this year, according to a July report from the Congressional Budget Office.
  • and
    • “Four more Medicare Advantage prescription drug plans have received five-star ratings thanks to CMS’ recalculation.” * * *
    • In a July 21 letter to MA organizations, CMS said ratings stayed the same for 61%, increased for 9% and declined for 30% of contracts. The agency did not change ratings for plans that had worse performance in the latest review. The threshold for MA plans earning additional payments is four out of five stars. Top plans get their own perks, though, such as special enrollment period privileges and further rebate benefits.
    • CMS clarified to Becker’s that it only updated overall ratings, not the separate Parts C and D summary ratings, on the plan finder.
    • Here are the four contracts joining the five-star club:
      • Renown Health
        • Hometown Health Plan (Senior Care Plus) — Contract H2960
      • Rifkin Managed Care Holding
        • Provider Partners Health Plan of Texas — Contract H4054
        • Provider Partners Health Plan of Pennsylvania — Contract H4093
      • Longevity Health Founders

From the Food and Drug Administration front,

  • MedPage Today tells us,
    • Nearly 100 people in 17 states have been sickened in a salmonella outbreak tied to recalled eggs, federal health officials said Friday.
    • The 98 people had illnesses that started between Nov. 21 and June 30, according to the FDA. No deaths have been reported, but 26 people have been hospitalized.
    • Investigators have determined that shell eggs recalled by Midwest Poultry Services are a likely source of the germ, but the Indiana-based company doesn’t account for all the illnesses.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
    • “Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
    • “SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
  • Fierce Pharma relates,
    • “The FDA has approved Otsuka Pharmaceutical’s once-daily extended-release capsule Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
    • “Approval of the first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) gives the Japanese drugmaker its “next major CNS launch” and positions the therapy to become a potential blockbuster in a large, under-penetrated market, according to Jefferies analysts in a July 26 note.
    • “Before Simtriyo can launch in the U.S. market, it must clear controlled-substance review by the Drug Enforcement Administration (DEA), a standard, up-to-three-month procedure for all central nervous system stimulants.”
  • Contemporary OB/GYN informs us,
    • “Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician’s order, the company noted in a July 24, 2026, news release.
    • “The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.
    • “BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.”
  • NBC News San Diego CA points out,
    • “The Food and Drug Administration has recalled a commonly prescribed thyroid medication.
    • “The recall involves levothyroxine sodium tablets that are used to treat hypothyroidism and decrease the size of enlarged thyroid glands, according to Mayo Clinic.
    • “The FDA said they had been functioning as “subpotent drugs,” meaning they had less of an active ingredient and were ultimately less effective.
    • “Major Pharmaceuticals packaged and distributed the recalled tablets, while Cardinal Health also distributed some of the recalled products.
    • “Twelve different dosages and cartons from the two companies were listed in the FDA’s recall notice. You can read the full list here.”

From the judicial front,

  • Bloomberg Law reports,
    • “Novo Nordisk A/S is asking a federal judge to halt Eli Lilly & Co.’s advertisements for its GLP-1 drugs, escalating a legal fight against the company’s campaign for weight loss treatments.
    • “The company said Friday [July 24] it filed a motion for preliminary injunction seeking to block Lilly’s advertisements of its obesity drugs, days after filing a lawsuit accusing the company of deceptive promotions. 
    • “Misleading advertisements that selectively compare lower doses of Novo Nordisk’s medicines against higher doses of Lilly’s medicines, based on outdated studies, leave patients with the mistaken impression that Lilly’s drugs are vastly superior, and that is simply not true,” John F. Kuckelman, senior vice president and group general counsel of Novo, said in a statement.”
  • and
    • “Johnson & Johnson on Monday said it agreed to a $5.5 billion commitment to resolve litigation related to claims that its talc products caused ovarian cancer. 
    • “The drugmaker said the proposed resolution represents “an efficient conclusion” to the lawsuits. The agreement requires the participation of lead plaintiff firms in ovarian talc litigation pending in state and federal court that represent at least 95% of claims, according to J&J. 
    • “While we are confident the company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives,” J&J Vice President of Litigation Erik Haas said in the statement on the company’s website.” 
  • Beckers Payer Issues identifies five health system vs. payer lawsuits to watch.

From the public health and medical / Rx research front,

  • Health Day reports,
    • “More than one-third of women and one-quarter of men engage in intentional outdoor tanning, with variance observed by age, race, physical activity level, and alcohol use, according to a study published online July 22 in JAMA Dermatology.
    • “Dawn M. Holman, M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the prevalence of intentional outdoor tanning among U.S. adults. The analysis included 31,615 adults participating in the 2024 National Health Interview Survey.” * * *
    • “These findings support the need to address intentional outdoor tanning in the context of skin cancer prevention,” the authors write. “The variation in demographic and behavioral factors points to venues for future research and interventions.”
  • The American Medical Association lets us know “what doctors want patients to know about summer skin safety” and “what doctors want patients to know about cardiac stress tests.“
  • The American Hospital Associagtion News relates,
    • “The Substance Abuse and Mental Health Services Administration July 27 released results from its latest national survey on drug use and mental health. The survey found that fewer adolescents 12-17 and adults 18-25 used alcohol, tobacco, marijuana and other drugs between 2021 and 2025. In addition, 27.6% of adolescents received mental health treatment in the past year, while 21.6% of adults 18 or older received treatment. The survey highlighted additional findings on suicide, substance use treatment and recovery.”
  • and
    • “The Association for the Advancement of Blood and Biotherapies Interorganizational Task Force on Domestic Disasters and Acts of Terrorism announced July 24 that the U.S. blood supply is at significant risk for shortages due to weeks of decline in blood donations. The task force said the reduced supply is more pronounced in certain areas of the country, and in some areas blood collectors are already reporting an impact on the availability of blood for some patients. The organization is urging eligible donors to make and keep an appointment to donate blood as soon as possible. An AHA Member Advisory will be issued on the matter, which will include a call to action and resources for conserving blood supplies.” 
  • MedPage tells us,
    • “Despite the availability of multivalent pneumococcal vaccines, infants remain susceptible to invasive pneumococcal diseases.
    • “In this French study, infants immunized against RSV with nirsevimab were about 35% less likely to be hospitalized for invasive pneumococcal disease through 9 months.
    • “The rise in pneumococcal disease cases in kids involving serotypes not covered by vaccines highlights the need for complementary prevention strategies, the researchers said.”
  • and
    • “Diabetes and weight loss are associated with an increased risk of fragility fractures, which can be associated with substantial morbidity and mortality.
    • “In this retrospective study of adults with type 2 diabetes, those starting a GLP-1 drug had a 21% lower risk of fragility fractures over 3 years compared with initiators of a DPP-4 inhibitor.
    • “The lower fracture risk associated with GLP-1 drugs was independent of changes in body mass index.”
  • Health Day adds,
    • “Worried that your Ozempic is becoming less effective over time?
    • “Don’t worry — you’re still eating less, even if you are feeling a bit hungrier, a new study says.
    • “People on semaglutide for weight loss continue to eat less even after they’ve taken the drug for more than a year, researchers report in the August issue of The American Journal of Clinical Nutrition.
    • “While some of the drug’s early reduction of hunger and food-related thoughts wanes over time, people continue to eat substantially fewer calories compared to others provided a placebo, researchers found.”
  • MedScape notes,
    • “A compression device worn around the abdomen during colonoscopy reduced cecal intubation time by more than 1.5 minutes and significantly lowered post-procedural pain, the need for manual abdominal pressure, and patient position changes. Greatest improvements were seen in patients who were lean or had obesity.”
  • Per a National Institutes of Health news release,
    • “Months to several years before amyotrophic lateral sclerosis (ALS) symptoms arise, levels of certain blood proteins may dramatically shift. Researchers analyzed data from the long-running, National Institutes of Health (NIH)-funded Pre-symptomatic Familial ALS (Pre-fALS) study, to identify a lineup of key proteins that may predict the emergence of clinically manifest ALS. By anticipating the arrival of symptoms, investigators could intervene with preventative therapies before the irreversible motor neuron damage that is characteristic of ALS sets in.
    • “If someone carrying an ALS-associated genetic variant had asked me in the past when they would become symptomatic, I would have struggled to provide a reasonable estimate,” said senior author Michael Benatar, M.D., Ph.D., a professor of neurology and public health sciences at the University of Miami. “These biomarkers give us a far better idea of the timing, allowing us to estimate the time to symptom onset with an average error of about 18 months. That’s something we can work with.”

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

  • Beckers Payer Issue tells us eight things to know about healthcare spending trends. 
  • Modern Healthcare reports,
    • “Cone Health CEO Dr. Paul Krakovitz said the system is focusing on value-based care coordination.
    • “Cone’s parent system, Risant Health [,a subsidiary of Kaiser Permanente], provides a national network with added scale and expertise to operate in a highly competitive healthcare market.
    • “Krokovitz said the system is expanding to take advantage of North Carolina’s booming population growth.” * * *
    • “We’re coming up on our second anniversary soon. The tools that Risant is bringing us in terms of value-based care and giving us national scale have been impressive. They’ve been very open-minded. Most importantly, they’ve stuck to the value of the deal, which has been making sure Cone Health remains a community-based health system.”
  • Beckers Hospital Review relates,
    • “King of Prussia, Pa.-based Universal Health Services recorded an operating income of $516.7 million (11.1% operating margin) during the second quarter of 2026, compared to an operating income of $500.3 million (11.7% margin) during the same period last year, according to its July 27 financial report.” * * *
    • “UHS operates 30 inpatient acute care hospitals, 346 inpatient behavioral health facilities, about 170 outpatient and other facilities, a health plan and a physician network in 40 states, Washington, D.C., Puerto Rico and the United Kingdom.”
  • Leapfrog posted its 2026 hospital safety ratings.
  • The Wall Street Journal informs us,
    • “Argenx agreed to buy Forte Biosciences for $2.2 billion to strengthen its immunology pipeline.
    • “The purchase price of $77 a share in cash represents a 41% premium to Forte’s closing price on Friday.
    • “The deal adds Forte’s experimental drug FB102, which Argenx said has potential to address multiple autoimmune diseases.”
  • and
    • “AstraZeneca reported higher second-quarter sales driven by cancer medicines and said it remains on track to hit its 2030 revenue target.
    • “AstraZeneca’s second-quarter revenue rose to $15.38 billion from $14.46 billion, driven by a 15% increase in oncology product sales.
    • “Chief Executive Pascal Soriot sought to reassure investors after a recent trial failure raised doubts about the company’s 2030 revenue goal.”
  • MedCity News discusses “What Happens When Patients Trust AI Over Their Doctor?”
    • As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.

Tuesday report

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

Simplicity is a virtue

From Washington, DC

  • Roll Call reports,
    • “Sen. Darline Graham took the oath of office Tuesday to fill the vacancy left by the unexpected death of her older brother, four-term Republican Sen. Lindsey Graham. The late Graham died Saturday night at age of 71 of an aortic dissection, according to preliminary findings by the D.C. medical examiner.”
  • and
    • “Speaker Mike Johnson narrowly freed the floor from another standstill Tuesday — but it’s not clear how long the good feeling will last.
    • “The House adopted a rule for floor debate in a 215-211 vote after GOP leaders won over key holdouts by promising a markup of border security legislation before the August recess and taking steps to graft a voter ID bill onto a spending measure.
    • “With such a slim majority, leadership can only afford to lose a few Republican votes for party-line measures.”
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing transformational reforms to Medicare’s physician payment and value-based care programs that would expand accountable care, modernize physician payment, reduce administrative burden, and help shift the healthcare system’s focus from treating illness to preventing it.
    • “The proposals would make Medicare accountable care organizations (ACOs) easier to join and more rewarding to participate in, transition clinicians away from traditional Merit-based Incentive Payment System (MIPS) reporting toward more meaningful value-based care pathways, and update physician payment policies to better reflect modern clinical practice. Together, these reforms would strengthen primary care, improve patient outcomes, and support Medicare’s long-term sustainability.
    • “We’re proposing some of the most significant Medicare reforms in recent years to strengthen primary care, expand accountable care, and modernize physician payment,” said CMS Administrator Dr. Mehmet Oz. “These changes would make it easier for clinicians to focus on prevention, improve coordination for patients, and ensure Medicare rewards better outcomes rather than more services.” * * *
    • “To view the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.federalregister.gov/public-inspection/current
    • “To view the related Quality Payment Program fact sheet, please visit: https://d2g5m5leph8kam.cloudfront.net/s3fs/s3fs-public/2026-06/2027-qpp-proposed-rule-factsheet.pdf
    • “For a fact sheet on the CY 2027 Physician Fee Schedule proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule
    • “For a fact sheet on the proposed Medicare Shared Savings Program changes in the CY 2027 PFS proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule-cms-1848-p-medicare-shared“
  • Radiology Business adds,
    • “Physicians with greater clinical knowledge are less likely to order low-value imaging and other unnecessary healthcare services, according to new research published Monday. 
    • “These wasteful tests and treatments—such as imaging for an uncomplicated headache, which provides no benefit to the patient—continue plague the U.S. healthcare system. Each year, the country spends an estimated $100 billion on low-value services, experts write in JAMA Internal Medicine. 
    • “Researchers recently aimed to better understand how higher physician knowledge might help to curb healthcare waste.  They utilized the American Board of Internal Medicine’s Longitudinal Knowledge Assessment to measure clinician know-how, matching it against IM’s ordering of 25 different low-value services including medical imaging. 
    • “Lead author Jonathan L. Vandergrift, MS, and colleagues found a clear connection, with high-knowledge docs less likely to order unnecessary scans.”
    • “These findings suggest an important question for further study: If those who scored lower in the first year increase their knowledge, and therefore their score, over time, will they then order fewer low-value services?” Vandergrift, a senior health services researcher at the ABIM, said in a news announcement July 13. “We hope to learn more about whether the healthcare system may cut unnecessary costs through education and assessments that steer clinicians toward higher-value care that provides the most benefit to patients.”
       
  • The American Hospital Association relates,
    • “The Health Resources and Services Administration announced that 340B covered entities purchased $100 billion in outpatient drugs under the federal 340B Drug Pricing Program in calendar year 2025. This represents an approximate 22% increase from CY 2024, which had sales of about $81.4 billion. HRSA partly attributed the growth to increased shifts from inpatient to outpatient care, a rise in innovative therapies and increases in drug pricing. Of the $100 billion in CY 2025 sales, 340B hospitals accounted for nearly 87%, or about $87 billion.”
  • Per a Government Accountability Office news release,
    • “In recent years, Medicare’s spending on hospice has nearly doubled. We looked at this spending and found that the way Medicare pays for hospice care could be costing taxpayers billions more than it should. 
    • “Today’s WatchBlog post looks at our new report about inefficiencies in Medicare’s payments.”

From the Food and Drug Administration front,

  • Beckers Hospital Review reports,
    • “The FDA has approved Sanofi’s subcutaneous Sarclisa Escena in combination with standard-of-care regimens for patients with multiple myeloma across all existing indications of the intravenous formulation, making it the first anticancer treatment administered through an on-body injector.
    • “Sarclisa Escena is administered through Sanofi’s on-body injector and is the first multiple myeloma treatment in the U.S. available through both an on-body injector and manual subcutaneous administration, according to a July 10 news release.”
  • Cure relates,
    • “The Food and Drug Administration (FDA) on July 14, 2026, granted traditional approval to Retevmo (selpercatinib) for adults and children 2 years of age and older with locally advanced or metastatic solid tumors that carry a RET gene fusion, as identified by an FDA-approved test.
    • “To be eligible, patients must have seen their cancer progress on or after prior systemic treatment, or have no satisfactory alternative treatment options available.
    • “The approval marks an upgrade from the accelerated approval Retevmo previously received for this indication — first for adult patients in 2022 and later extended to pediatric patients ages 2 and older in 2024. Traditional approval is granted when a drug’s clinical benefit has been confirmed through additional clinical evidence.”
  • MedTech Dive reports,
    • “Medtronic is removing from the market certain lots of a catheter used to place pulmonary valves, the Food and Drug Administration said in a Monday recall notice.
    • “The affected devices have an increased risk that the distal tip may detach from the delivery catheter system, requiring another procedure to remove the tip. As of May 14, Medtronic had not reported any serious injuries or deaths associated with the issue, according to the FDA notice.
    • “A Medtronic spokesperson said in an emailed statement to MedTech Dive that the problem is limited to certain delivery systems and does not involve the valve itself. Medtronic has resolved the underlying manufacturing problem, so future shipments will not be affected by the recall, the spokesperson wrote.”

From the judicial front,

  • Healthcare Dive reports,
    • “CVS Health’s Caremark has reached a settlement with the Federal Trade Commission requiring notable changes to the pharmacy benefit manager’s business practices, including that Caremark prefer the lowest-cost drugs on its standard formularies and pass through savings negotiated with drugmakers to clients.
    • “The settlement announced by the FTC on Tuesday puts to bed regulators’ allegations that Caremark preferred more expensive versions of insulin in order to increase its rebates, driving up prices for the lifesaving diabetes drug. The FTC lodged the suit against Caremark, along with fellow PBM giants Express Scripts and Optum Rx, in 2024.
    • “Express Scripts settled with the FTC in February while Optum Rx is still finalizing an agreement with the antitrust agency.”
    • “The terms of CVS’ settlement are very similar to those secured with Express Scripts. The deal prevents the drug middleman from discriminating against cheaper drugs in its standard formularies for commercial clients, and requires it to provide a standard offering to plan sponsors that doesn’t include rebates.
    • “It requires Caremark to include any purchases a patient makes through TrumpRx, President Donald Trump’s online drug marketplace, towards the deductible in certain health plans, once regulatory changes make that possible. The settlement also includes a number of transparency provisions.
    • However, the CVS deal includes a new wrinkle meant to assuage concerns that the healthcare behemoth leverages its market power to prevent independent pharmacies from working with rival pharmacy hubs, third-party companies that provide a range of digital pharmacy services.
    • “The settlement prevents CVS from foreclosing hub service providers [FEHBlog provided link], and will create a monitor to ensure its compliance, according to the FTC.”
  • Modern Healthcare reports,
    • “The U.S. Justice Department (DOJ) sent civil investigative demands to lawyers in private litigation against Claritev [formerly known as Multiplan], escalating its antitrust probe.
    • A federal judge in June 2025 rejected Claritev’s bid to dismiss the private suits, keeping the cases alive.
    • The DOJ also has a separate ongoing antitrust investigation into one of Claritev’s major insurer clients.
  • Reuters relates,
    • “A coalition of public health organizations, pediatricians and parents sued the U.S. Food and Drug Administration on Tuesday, challenging a ​new policy that allow some manufacturers to sell vapes and ‌nicotine without the legally required license.
    • “The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. The guidance states the agency would ​not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch ​products if the companies have marketing applications under review.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Michigan state health officials are narrowing in on lettuce as a possible culprit in the rapidly expanding explosive-diarrhea outbreak, though federal authorities say they are still working to confirm a specific food source as the cause.
    • “Donald Prater, the Food and Drug Administration’s acting deputy commissioner for food, said lettuce is one of multiple produce items under investigation as officials race to identify the outbreak’s origins.
    • “Top health officials in Michigan said bagged, prewashed salad kits could be a particular risk, based on the state’s review of cases.
    • “The early signals are telling us that lettuce does seem to be implicated,” said Dr. Natasha Bagdasarian, the state’s chief medical executive.
    • “Michigan is the hardest hit by the cyclospora parasite, with more than 3,300 cases as of Tuesday, more than double the number on Friday.”
  • The American Hospital Association News adds,
    • “The Centers for Disease Control and Prevention July 14 released an advisory on the growing cyclosporiasis cases across the U.S. The advisory said that the agency received reports of 1,645 confirmed domestic cases across 34 states and is aware of more than 5,100 cases that require further analysis for confirmation. The CDC said that of 1,645 case-patients with available information, 9% (141) were hospitalized and no patients have died. The advisory includes recommendations for clinicians on how to diagnose and treat patients with cyclosporiasis, and for facilities on how to disinfect healthcare settings. The CDC is working with the Food and Drug Administration and state and local health departments to identify the cause of the illness. The CDC said that because cyclosporiasis is often underdiagnosed and underreported, the actual total of illnesses is likely higher than what has been reported.”
  • Healio relates,
    • “Alcohol consumption and smoking were identified as the two strongest common risk factors for breast cancer and atrial fibrillation globally, according to data published in the Journal of the American Heart Association.
    • “Reducing alcohol intake and smoking behaviors to the level at which risk is smallest, nearly one-third of breast cancer cases and 12% of AF cases could be prevented, the researchers wrote.
    • “One of the most surprising aspects of our findings was how common both breast cancer and atrial fibrillation/flutter diagnoses were among women ages 55 and older in high-income regions, which highlights the influence of lifestyle,” Shu Wang, MD, PhD, director of the Breast Disease Center at Peking University People’s Hospital in Beijing, said in a press release. “This is the first study combining global data with machine learning to show the relationship between the conditions, their location across the world and the shared risk factors of these two conditions.”
  • STAT News adds,
    • “STAT’s interviews with more than 100 experts — including current and former government officials, doctors, public health advocates, substance use researchers, people in recovery, and addiction treatment leaders — identified a dozen ways the U.S. could chip away at its alcohol epidemic.” Here are the first six:
      • Screen early and often
      • “Add ‘nudges’ to health system
        • “Health systems can do their part to boost screening and treatment by adding alcohol questionnaires, including the well-validated and quick AUDIT-C test, to clinician workflows.”
      • “Get creative with funding
        • “STAT’s reporting finds that fixing the country’s alcohol epidemic will require smarter investments and clear guidance from federal health officials.”
      • “Get the word out
        • “HHS could also reinvest in public messaging about the health risks of alcohol, such as the defunct “Drink Less, Be Your Best” campaign.” 
      • “Overhaul payment 
        • “In the clinic, payment continues to be a barrier to detection and treatment of alcohol-related problems. While health care reforms in the past two decades have boosted reimbursement for mental health treatment, including substance use disorder work, physicians say parity is still not enforced well enough.”
      • “Dive into data
        • “Even without spending more on alcohol interventions, the country could use information it already has, plus a bit of cleverness, to tackle the issue.” 
  • The National Institutes of Health’s Research Matters covers the following topics in its latest post:
    • “Brain-computer device helps man speak
      • “A man unable to talk due to paralysis successfully used a brain-computer interface system at his home to speak.
      • “This technology could become a practical communication tool for people who can’t talk because of problems with their muscles.”
    • “Sleep and exercise may reduce mutation-driven inflammation 
      • “Lifestyle factors may reduce inflammation caused by some mutations in blood stem cells, according to an analysis of human and mouse data.
      • “The results suggest improving sleep and exercise may curb the health consequences of this inflammation.”
    • “Fructose and glucose trigger different brain responses
      • “Scientists found the sugars glucose and fructose affect hunger-controlling brain cells and food preferences in mice differently.
      • “The study suggests that similar nutrients can signal to the brain through distinct pathways and have different effects on appetite.”
  • MedCity News explains
    • “How AI Can Support Better Mental Health Outcomes — With Humans at the Center.
      • “Mental health care does not need to become less human to become more effective. The most effective (and responsible) path forward is one built on partnership.”
  • Genetic Engineering and Biotechnology News tells us,
    • “Researchers at University College London (UCL) Great Ormond Street Hospital for Children (GOSH) have built a new lab model of infant lungs to show why respiratory syncytial virus (RSV) makes infants so much sicker than adults, and to allow them to test new treatments. The miniature model of a baby’s airways was created using pediatric airway cells, blood vessel cells, and neutrophils (a type of white blood cell that acts as the immune system’s primary response to infection).
    • “Studies using the new model suggest that future therapies for RSV should target both the virus and its immune response to ensure babies get the best possible outcomes. Research lead Claire Smith, PhD, at UCL Great Ormond Street Institute of Child Health, said, “This model allows us to watch early immune responses unfold and study them in a human setting that reflects the infant airway. That’s something animal models often struggle to capture, especially when it comes to age-specific effects.
    • “Senior and corresponding author Smith and colleagues reported on their findings in Nature Communications in a paper titled “Neutrophil myeloperoxidase as a functional biomarker for RSV severity: implications for in vitro therapeutic screening.” In their report they concluded, “These findings identify neutrophil–epithelial interactions as a useful target for intervention and support the use of physiologically relevant human models to accelerate the development of therapies that limit immunopathology while preserving antiviral defense.”
  • BioPharma Dive informs us
    • “Detailed findings from a closely watched clinical trial hint that a new kind of drug may offer similar benefits as approved medicines in early Alzheimer’s disease, a result that could boost the outlook for a long-studied but unproven area of scientific research.
    • “The mid-stage “Celia” trial explored whether a Biogen drug codenamed BIIB080 would be any better than a placebo at slowing the mental or functional decline of Alzheimer’s patients showing early signs of cognitive impairment. Unlike in-use therapies such as Eli Lilly’s Kisunla and Biogen and Eisai’s Leqembi, which target harmful “amyloid” proteins, BIIB080 works by gumming up the genetic instructions cells use to create another Alzheimer’s-linked protein called tau.”
  • Fierce Pharma adds,
    • “Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase (HDAC) inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Opdivo in a phase 3 trial of patients with advanced skin cancer.
    • “The study, which included 404 melanoma patients across 15 countries, achieved its primary endpoint, as the combo produced a clinically meaningful improvement in progression-free survival. 
    • “Those who received HBI-8000 plus Opdivo remained alive and without their disease worsening for a median of 11.7 months, compared to a median of 7.4 months for those who were given Opdivo plus placebo. The 58% improvement was deemed statistically significant.”  

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

  • The Wall Street Journal reports,
    • “HCA Healthcare lowered its 2026 financial guidance following payer mix shifts due to health insurance exchanges.
    • “The company said the payer mix shift was driven by an increase in uninsured patients who had lost coverage on health insurance exchanges.
    • “HCA estimated that the payer mix shift had an unfavorable impact on income before income taxes of about $400 million during the second quarter.” * * *
    • “The company said it anticipates adjusted Ebitda for the second quarter of roughly $4.03 billion, and revenue for the three months of about $20.23 billion. That compared with $3.85 billion and $18.61 billion a year earlier, and is below the $4.47 billion and $19.47 billion in revenue that analysts polled by FactSet had penciled in.” * * *
    • “The company said it did see positive factors during the quarter, including growth in admissions, equivalent admissions and emergency room visits, increased benefit from Medicaid Supplemental Payment Programs and improved expense trends.”
  • Beckers Hospital Review relates,
    • “Madison, Wis.-based UW Health has reached an agreement with Marshfield Medical Center-Beaver Dam (Wis.) to bring the medical center into the health system.
    • “The hospital is part of Marshfield (Wis.) Clinic Health System, which merged with Sioux Falls, S.D.-based Sanford Health in January 2025 to create a 56-hospital, nonprofit integrated system that operates as Sanford Health. 
    • “Marshfield Medical Center-Beaver Dam is an integrated medical campus that comprises a hospital, skilled nursing facility and independent senior living apartments. The hospital also runs two assisted living facilities and primary care clinics, according to a July 13 UW Health news release shared with Becker’s.” 
  • and
    • “Little Rock, Ark.-based Baptist Health acquired Magnolia (Ark.) Regional Medical Center on July 12. 
    • “With the close of the acquisition, the 25-bed facility has been rebranded as Baptist Health Medical Center-Magnolia. 
    • “Magnolia became Baptist Health’s 14th hospital and the second acquired in less than one month. On June 14, Baptist completed its acquisition of South Arkansas Regional Hospital, a 151-bed hospital based in El Dorado. 
    • “Baptist Health signed a definitive agreement to acquire the Magnolia hospital in April.” 
  • Fierce Healthcare tells us,
    • “The American Medical Association (AMA) announced Tuesday a new interoperability initiative aimed at supporting electronic prior authorizations by better connecting clinical terminology to its Current Procedural Terminology (CPT) administrative coding.
    • “The professional association said Tuesday it will be developing and deploying SNOMED CT— a structured set of descriptive terms that serve as a shared medical vocabulary for computer systems—to CPT terminology mappings. Doing so will ultimately create a foundation for “scalable automation” to streamline workflows, improve data exchange and foster more efficient and quicker prior authorization outcomes, AMA said.
    • “Moreover, it aligns with the upcoming Jan. 1, 2027 Centers for Medicare & Medicaid Services (CMS) FHIR-based prior authorization compliance deadline.”
  • Fierce Pharma informs us,
    • “Nearly a decade after spinning out its Chinese research hub to form Dizal Pharmaceutical, AstraZeneca is paying up to $1.5 billion to buy a piece of the pipeline, securing exclusive global rights for the biotech’s oral EGFR lung cancer drug Zegfrovy (sunvozertinib).
    • “The total deal value is split between $600 million in upfront payment, up to $400 million in development milestones and another $500 million tied to certain sales milestones, according to a disclosure (Chinese, PDF) to the Shanghai Stock Exchange. Dizal is also entitled to tiered, up to low-double-digit royalties based on Zegfrovy’s global sales.
    • “The deal comes about a month after Dizal detailed positive phase 3 data for Zegfrovy in first-line non-small cell lung cancer with EGFR exon 20 insertion mutations at the 2026 American Society of Clinical Oncology annual meeting.
    • “In the global Wu-Kong28 trial, Zegfrovy significantly reduced the risk of disease progression or death by 35% compared with platinum-based chemotherapy.” 
  • and
    • “Insulet’s wearable insulin patch Omnipod may be able to seamlessly control insulin delivery for patients with diabetes, but it can’t fill all mental health-related treatment gaps on its own. To broaden its network of personalized care offerings, the company is teaming up with mental health platform Calm to roll out a host of holistic “Mind in Range” resources. 
    • “Insulet and Calm’s free-to-access mindfulness tools, launched Tuesday, July 14, are specifically tailored to the diabetes community and include short meditations, a breathing exercise and a new Calm Sleep Story narrated by fashion model Lila Moss, a diabetes patient and advocate. The collaboration marks Calm’s first integrated content partnership with a medtech company and aims to “normalize conversations” around mental health care in diabetes management, while also making mindfulness “simple and accessible,” Insulet explained in a release.” 
  • Beckers Hospital Review points out,
    • “Amazon Pharmacy is collaborating with eNavvi, a digital prescribing platform, to integrate real-time medication pricing, availability and home delivery options into clinicians’ e-prescribing workflow. 
    • “The integration gives clinicians visibility into medication costs by comparing cash prices with estimated insurance copays while automatically applying eligible manufacturer discounts, according to a July 14 news release. It also provides real-time inventory information and delivery estimates, allowing providers to make prescribing decisions based on medication availability and delivery timelines.
    • “The move builds on Amazon Pharmacy’s ongoing delivery expansion, which is on track to reach 4,500 U.S. cities and towns by the end of 2026. The company has also leaned into GLP-1 access, expanding Zepbound KwikPen availability through same-day delivery earlier this year. 
  • Beckers Health IT lets us know,
    • “OpenEvidence outperformed Claude Opus 4.8, Gemini 3.1 Pro and GPT-5.5 on real-world clinical questions in a new physician-graded study, contradicting a June Nature Medicine paper that foundgeneral-purpose AI models beat specialized clinical tools.
    • “The study, posted June 27 as a preprint on arXiv, has not yet been peer-reviewed. It had 149 practicing physicians across 36 states rate AI answers to 620 real point-of-care questions drawn from OpenEvidence’s platform, plus 187 questions from the HealthBench benchmark, judging responses on accuracy, clinical utility, source quality, verifiability and completeness.
    • “OpenEvidence posted positive win margins on all five dimensions, with differences ranging from 25 to 39 percentage points over the three general-purpose models. Claude Opus 4.8 and Gemini 3.1 Pro scored near parity with each other, while GPT-5.5 recorded the lowest win rates on every axis.”
    • “The results stood in contrast to a Nature Medicine study published June 12, which found GPT-5.2, Gemini 3.1 Pro and Claude Opus 4.6 outperformed OpenEvidence and Wolters Kluwer’s UpToDate Expert AI. OpenEvidence has since asked Nature Medicine to retract that study, alleging flawed methods; the journal has pointed the company to its formal rebuttal process instead. * * *
    • “The competing results leave hospital and health system leaders with conflicting independent evidence on how general-purpose AI models compare with specialized clinical decision support tools as adoption of both accelerates.”

Tuesday report

David Ermer–Agentic & Generative AI, Congress, FDA, Medical / Rx research, NIH, No Surprises Act, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Roll Call reports,
    • “House Republican leaders are giving up on trying to put the pieces back together for a rule needed to take up a raft of pre-recess legislative priorities after a group of GOP rebels blocked the procedural measure earlier, largely over lack of movement on voter ID requirements.
    • “The decision to send members home early for the July Fourth recess after Tuesday afternoon votes came after Speaker Mike Johnson, R-La., huddled in his office with Rules Chairwoman Virginia Foxx, R-N.C., and others on how to reconstruct a path forward.” 
  • Modern Healthcare relates,
    • “A bipartisan House bill would require extensive reporting on private equity firms’ healthcare holdings and ownership structures.
    • “The draft measure could reveal tactics such as sale-leaseback arrangements like those that contributed to Steward Health Care’s bankruptcy.
    • “Some Democrats want to go further than transparency and say enforcement needs to be tougher.”
  • Beckers Hospital Review tells us,
    • “A growing number of states are moving to cap what hospitals can charge commercial payers and employers, turning hospital pricing into one of the most active battlegrounds in state health policy.
    • “Several states enacted hospital price caps in 2025, and the 2026 legislative sessions have brought a fresh wave of proposals tied to Medicare rates, according to The Commonwealth Fund. ” * * *
    • “For now, the cap fight is a state story. The federal government’s lever on hospital prices has been transparency and site-neutral payments, not price ceilings.
    • “CMS finalized price transparency rules requiring hospitals to post median and percentile allowed amounts in their machine-readable files, with enforcement beginning April 1, 2026. In June, the White House warned more than 500 hospitals to post pricing information or face fines. CMS also expanded site-neutral payment policies in its 2026 outpatient rule, aligning some hospital outpatient rates with lower-cost settings. Meanwhile, renewed scrutiny of the 340B drug discount program has systems bracing for further cuts.
    • “What began as isolated state efforts has evolved into a broader movement to rein in hospital prices. Whether these policies ultimately lower costs without undermining hospital finances will likely shape the next chapter of healthcare affordability debates.”
  • ZeroHedge shares different perspectives on the Affordable Care Act plan’s enrollment loss.
    • Obamacare enrollment declined by nearly 3 million in 2026, sparking renewed debate about the affordability of healthcare in America.
    • “National politicians and policy experts disagreed on the reasons for the dip in enrollment, with some saying that it was driven by rising premiums. 
    • “Others said the decline was evidence that program integrity measures taken by the Trump administration were successful in rooting out fraud and waste.” 
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services June 30 announced it will terminate emergency use authorization declarations for certain drugs and medical devices used to treat COVID-19, saying circumstances justifying the authorizations no longer exist. The declaration for drugs and biological products will end June 29, 2027, while the declaration for medical devices will end Dec. 26, 2026. The EUA declarations were issued in 2020 to accelerate access to medical products during the COVID-19 pandemic.” 
  • Per a U.S. Office of Personnel Management news release,
    • “The US Office of Personnel Management (OPM), in partnership with the US Department of War (DOW), today announced the launch of War Force, a DOW-specific recruiting initiative under OPM’s Tech Force program designed to attract exceptional software engineers to support the nation’s most critical national security missions.
    • “Through War Force, OPM will recruit top engineering talent from across the country and connect qualified candidates with high-impact technical roles at the Department of War. The initiative builds on the success of Tech Force by tailoring recruitment to the Department’s unique operational and mission requirements.
    • “America’s national security depends on attracting the best technical talent to some of government’s most important missions,” OPM Director Scott Kupor said. “War Force builds on the momentum of Tech Force by connecting outstanding engineers with opportunities to solve complex challenges alongside the War Department. We’re making it easier for top talent to serve their country through meaningful technical work.” * * *
    • “Applicants must be US citizens and eligible to obtain and maintain a Secret/Top Secret clearance. Applications close July 10, 2026. View the job announcement and apply here.”

No Surprises Act news

  • Beckers ASC News reports,
    • “Some surgical assistants are using arbitration provisions in federal billing law to collect far more than the surgeons they assist, according to The New York Times.
    • “Surgical assistants are typically paid a standard fee equal to about 16% of a surgeon’s reimbursement. But some are now collecting far more than the surgeons they assist by capitalizing on a law meant to protect patients from surprise billing, according to a New York Times report.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “The Food and Drug Administration is losing another top drug reviewer in Vijay Kumar, who intends to step down as acting director of the office of gene and cell therapy reviews in the Center for Biologics Evaluation and Research, a spokesperson said Tuesday.
    • “Acting CBER Director Karim Mikhail will serve as the acting director of the Office of Therapeutic Products “to ensure absolute regulatory continuity” while the FDA seeks candidates for the role within and outside the agency, the spokesperson said. Kumar will remain with the FDA, having been elevated to the acting director role from his position as lead physician.
    • “Kumar’s decision comes amid personnel turbulence at the FDA, following the resignation of former Commissioner Marty Makary and CBER Director Vinay Prasad, along with the firing of Tracy Beth Høeg as director of the Center for Drug Evaluation and Research. Multiple top-level positions at the agency are staffed by officials in time-limited acting roles, without a clear indication when they will be filled permanently.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult patients with high-risk blood cancers. It addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.
    • “Tregzi uses stem cells and immune cells collected from blood of a closely matched donor to help the body fight cancer while reducing the risk of a serious complication called chronic GVHD — a condition that can occur when transplanted donor blood cells attack the patient’s body. Patients receive this treatment after undergoing chemotherapy to prepare their bodies for a bone marrow or stem cell transplant.
    • “For patients with blood cancers who need stem cell transplantation, chronic graft-versus-host disease has long been one of the most feared and difficult-to-prevent complications,” said Karim Mikhail, B.Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval offers a genuine new approach that can help reconstitute the immune system while substantially reducing that risk and reflects the promise of what cellular therapy can deliver for patients.”  
  • The Wall Street Journal relates,
    • “U.S. officials are allowing Zyn to market itself as being less harmful than traditional cigarettes, making the product the first nicotine pouch on the market to be granted such a distinction.
    • “The Food and Drug Administration announced that 20 different Zyn nicotine pouches—including flavors ranging from cool mint to cinnamon—can carry language stating that using the pouches instead of smoking cigarettes puts users at a lower risk of mouth cancer, stroke, heart disease, lung cancer, emphysema and chronic bronchitis.
    • “Zyn nicotine pouches, a product of Swedish Match USA which is owned by Philip Morris International PM -1.07%decrease; down pointing triangle, contain no tobacco and are the most popular brand in the U.S. They were granted permission to stay on the market in early 2025, the first pouch to receive the authorization.
    • “Nicotine pouches look similar to small tea bags and are filled with nicotine, salt and can contain other materials like flavorings and wood pulp.” 
  • Beckers Hospital Review tells us,
    • “The New England Journal of Medicine has retracted the clinical trial publication behind Amgen’s rare disease drug Tavneos after two of the study’s authors requested the retraction over undisclosed changes to how patient outcomes were assessed. 
    • “In a June 29 retraction statement, NEJM said the primary endpoint assessments for nine patients were readjudicated after the trial’s database was locked and unblinded, without the two authors’ knowledge, calling the omission “inconsistent with proper research conduct.”
    • “The retraction is the latest setback in a months-long dispute between Amgen and the FDA over Tavneos, a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis that Amgen acquired through its $3.7 billion purchase of ChemoCentryx in 2022. The FDA first asked Amgen to voluntarily withdraw the drug from the market in January, citing concerns over how ChemoCentryx had re-adjudicated efficacy data for nine of the 331 patients in the pivotal trial. Amgen declined the request on Feb. 3, saying it was not aware of issues with the underlying patient data and that its own review of clinical findings and real-world evidence continued to support the drug’s effectiveness.”
  • Per Cardiovascular Business,
    • “Stryker is recalling its InZone Detachment System due to a potential battery issue. The recall includes a total of nearly 45,000 devices. 
    • “The InZone Detachment System helps interventional radiologists and neurosurgeons perform neurovascular embolization procedures to treat intracranial aneurysms, and neurovascular abnormalities such as arteriovenous malformations and fistulae. The device is also indicated for arterial and venous embolizations in the peripheral vasculature.
    • “The device, compatible with a variety of detachable coils, was designed to detect potentially challenging conditions and adjust as necessary. It includes a detachment button, a series of LED indicators and a cable connection port.”
  • and
    • “Artivion, an Atlanta-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its AMDS Hybrid Prosthesis.
    • “The AMDS was designed to help clinicians treat DeBakey Type 1 dissections complicated by malperfusion. It works as a complement to hemiarch replacement, preserving the native arch and making reinterventions possible if needed. According to Artivion, it is the first surgical device of its kind.
    • “In December 2024, the AMDS received the FDA’s Humanitarian Device Exemption (HDE). This allowed select patients to undergo treatment with the device, but a separate institutional review board (IRB) approval was still required in each instance. Thanks to this full approval, the AMDS is now covered across the board for the treatment of all DeBakey Type 1 dissections with clinical or radiographic malperfusion.”

From the public health and medical / Rx research,

  • The New York Times reports,
    • “Two of the hottest trends in health — longevity medicine and weight loss drugs — are colliding.
    • “A theory that GLP-1 medications like Ozempic or Zepbound might help people live longer has been bandied about by biohackers and aging researchers for several years. Online pharmacies already market compounded versions of the drugs to purportedly extend health span. But so far, academic research into the hypothesis has been scant.”
  • Per a National Institutes of Health news release,
    • “The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All of Us as the world’s largest integrated genomic and electronic health record (EHR) database. The latest data release includes more than 535,000 whole genome sequences linked to nearly 482,000 electronic health records, a combination of genomic depth and clinical breadth unmatched by any research program in the world.
    • “There’s a paradox at the heart of precision medicine,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “To tailor treatments to individuals, you actually need very large populations to uncover the patterns that connect genetics, lifestyle, and the environment to health outcomes. That is exactly what All of Us provides: research at unprecedented scale.”
    • The new data issuance represents growth of more than 114,000 participants since the previous data version, bringing the program’s total enrolled-participant count to over 883,000. The dataset now encompasses more than 1.3 billion genetic variants, 553,000 genotyping arrays, 96,000 structural variant records, and 600,000 physical measurements, alongside 747,000 survey responses capturing social circumstances, behaviors, and environments. EHR data grew by 22% in this release, driven by expanded data sources including participant-mediated EHR submissions and health information exchange data.
    • “All of Us reflects the trust of people across the country who chose to contribute to research to benefit everyone,” said All of Us Research Program CEO Josh Denny, M.D. “This release puts a richer dataset into the hands of scientists working on real clinical problems. This is how we advance the health of all Americans.”
  • Health Day relates,
    • “Many young adults may be missing important preventive healthcare screenings, according to a national survey.
    • “The poll of more than 1,000 U.S. adults, commissioned by Ohio State University in Columbus, found only 71% of people ages 18 to 29 have a regular doctor, compared with 97% of adults 65 and older.
    • “Even among young adults who do have a doctor, fewer than half — just 47% — had a checkup in the past year.
    • “The authors say skipping routine visits can mean missing recommended screenings, vaccines and early warning signs of conditions like high blood pressure, high cholesterol and diabetes.
    • Dr. Zachary Bittinger, a family medicine physician at Ohio State University Wexner Medical Center, said having a primary doctor is especially important when you are young.
    • “We look ahead five years, 10 years and 20 years, because that’s ideally how long you see your primary doctor,” he said. “That kind of relationship means that for each stage of life, from college to raising children to retirement, you get the kind of advice that keeps you safe.”
  • MedPage Today informs us,
    • “A large population-based cohort study in Hong Kong demonstrated that acetaminophen (Tylenol) use during pregnancy was unlikely to increase the risk of autism spectrum disorder or attention deficit-hyperactivity disorder (ADHD) in exposed children.
    • “In sibling-matched analyses, prenatal acetaminophen exposure was not associated with autism (adjusted HR 1.00, 95% CI 0.91-1.11) or ADHD (adjusted HR 1.01, 95% CI 0.93-1.08), reported Eric Yuk Fai Wan, PhD, of the University of Hong Kong, and co-authors.
    • “Findings were consistent regardless of when exposure happened, the cumulative acetaminophen dose, or how often the drug was used, the researchers wrote in JAMA Internal Medicine.
  • MedCity News discusses “The Terminology Gap Undermining Cervical Cancer Screening Guidelines.”
    • “While the Pap identifies the cell changes, the HPV test determines the root cause before those changes even happen. Both tests have saved lives. But they are not interchangeable, and treating them as such puts the patient at risk.” 
  • Genetic Engineering and BioTechnology News points out,
    • “Neurodegenerative diseases affect tens of millions of people worldwide. A new study published in Cell Death Discovery titled, “Sustained dysregulation of iron and glutathione homeostasis induces chronoferroptosis, a persistent ferroptotic adaptation in neuronal cells,” points to iron accumulation as a key target in the effort to predict, prevent, and treat neurodegenerative diseases. 
    • “Resilience has become a huge topic of discussion when it comes to Alzheimer’s disease and other neurodegenerative disorders, trying to make the brain more resilient in the face of stressors that contribute to neurodegeneration,” said Pam Maher, PhD, co-corresponding author and a research professor at the Salk Institute. “Our study reveals that cells lose resilience when iron hits a certain level, making neurons more susceptible to stressors that damage or even kill them.”
    • “Found in dark leafy greens, starchy cereals, lean meats, seafood, and other common foods, iron helps red blood cells develop, carries oxygen, makes hormones, and engages in key functions across the immune system and energy production. 
    • “It’s one of the most important minerals in the body,” says co-corresponding author Nawab John Dar, PhD, a postdoctoral researcher in Maher’s lab. “So, it isn’t the iron itself that is a problem with age. It is this accumulation of iron over time that is the problem.” 
  • BioPharma Dive notes “10 clinical trials to watch in the second half of 2026.”
    • “The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.”

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

  • Beckers Payer Issues reports,
    • “Some CEOs may come and go. But David Cordani, the outgoing CEO of The Cigna Group, has been with the company for around 35 years, becoming president in 2008 and CEO in 2009.
    • “Mr. Cordani departs his role July 1 but will remain as executive chair of the board. Prior to his Cigna head executive position, Mr. Cordani assumed leadership roles in finance, marketing and operations across the company. Later, he played a broader role in the health insurance landscape, as well, serving as AHIP chair in 2019. 
    • “During his time as Cigna’s CEO, Mr. Cordani gave the company a major makeover, betting big beyond insurance. Those bets appear to have paid off: In 2025, the company brought in about $275 billion in revenue, up from roughly $18 billion when Mr. Cordani began his tenure, according to Cigna. The company now employs more than 70,000 and serves about 185 million customer and patient relationships across its business lines.
    • “Since becoming CEO, one of Mr. Cordani’s boldest moves was the $67 billion acquisition of pharmacy benefit manager Express Scripts in 2018. The deal survived Justice Department scrutiny and ultimately paved the way for Cigna to unify health services under the Evernorth Health Services brand in 2020. In 2025, Evernorth brought in nearly $235 billion in revenue, with more than $132 billion from pharmacy benefit services and $102 billion from specialty and care services.”
  • The American Hospital Association News relates,
    • “The AHA June 30 announced the appointment of Steve Walsh as its next president and chief executive officer. Walsh, who has served as president and CEO of the Massachusetts Health & Hospital Association since 2017, will assume leadership of the nation’s largest hospital and healthcare system membership organization this fall.  
    • “Following a thoughtful national search, the Board unanimously selected Steve Walsh to serve as the next President and Chief Executive Officer of the American Hospital Association,” said Marc L. Boom, M.D., chair of the AHA Board of Trustees and president and CEO of Houston Methodist. “Steve is a proven healthcare leader, innovator and accomplished advocate for healthcare improvement, who understands both the challenges facing hospitals and the opportunities ahead. Throughout his career, he has demonstrated an ability to bring people together, build consensus and advance meaningful solutions on behalf of patients, caregivers and communities.” 
    • Boom also thanked and praised outgoing AHA President and CEO Rick Pollack, noting the “Board’s decision reflects our confidence that Steve is uniquely prepared to build upon the strong foundation established by Rick Pollack while helping the Association strengthen its role as a trusted voice, convener and advocate for health care providers across America.” 
  • Modern Healthcare tells us,
    • “Empath units are gaining national attention for improving care for people in crisis while reducing the strain on ERs ill-equipped to treat them.
    • “M Health Fairview Southdale Hospital loses $500,000 annually on its Empath psychiatric unit due to insufficient government reimbursements.
    • “Hospitals are pressing for higher payments for such visits, which are less intensive than inpatient admission but more involved than outpatient therapy.”
  • MedTech Dive informs us
    • “Zimmer Biomet has agreed to pay up to $140 million to acquire Pacira BioSciences’ iovera pain relief device, the companies announced Tuesday.
    • “Zimmer has agreed to pay $70 million upfront and up to $70 million more in revenue-based milestones through 2031. Zimmer will acquire the rights to develop, manufacture and sell iovera as part of the agreement. 
    • “BTIG analyst Ryan Zimmerman wrote in a research note Tuesday that the acquisition complements Zimmer’s existing product portfolio. Iovera has room to expand into new markets and is supported by legislation that went into effect last year to expand access to non-opioid pain treatments.”
  • Per STAT News,
    • “Anthropic, the artificial intelligence firm, on Tuesday announced the availability of Claude Science, an application that optimizes the company’s large language model for use in scientific laboratories and, especially, within the research operations of pharmaceutical companies.
    • “At a launch event here, Anthropic CEO Dario Amodei said that until now, humans have wrestled with the complexity of biology only with their minds. While biology is not as simple or clean as code, he still thinks it can be just as powerful in this domain.
    • “It’s going to be a general purpose technology that helps us to make sense of that complexity, in its full complexity, better.” But, he admitted, “We don’t know for sure if that’s going to work out. But I think we’re seeing signs that we’re seeing the beginnings of it.”
    • “The product is a beachhead in Anthropic’s larger battle for the future of biology. The firm has ambitions so big they would seem caricature-like were it not for its financial means. A month ago Anthropic said it had reached annualized sales of $42 billion — about as much as the drug giant GSK — and that it is valued, based on a $65 billion funding round, at $965 billion, far more than any health care company except Eli Lilly.”

Midweek report

David Ermer–Congress, COVID-19, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • FedWeek reports,
    • “OPM has sought to allay privacy concerns about its plan to access detailed medical information on FEHB/PSHB enrollees, with one of the organizations that raised such concerns—the National Active and Retired Federal Employees Association—cautiously optimistic that OPM is addressing them.
    • “In a Federal Register notice posted in December, but which only drew attention months later in April, OPM proposed to gain access to carriers’ records including office visits, treatment, prescriptions and other medical information, without a requirement that they withhold personally identifying information.” * * *
    • “He said that OPM’s inspector general’s office—which has access to such information for its audits of health plans and carriers—“will provide an encrypted copy of that data to OPM – but only after stripping out names, social security numbers, phone numbers, addresses (except for ZIP codes), and other personally identifiable data. The only member-level PII fields that will remain in the data that OPM receives will be our member’s ZIP codes, year of birth, and their member ID.”
    • “He said that OPM further will replace the member ID with random numbers and characters and that the data “will remain in a secure, separate environment, encrypted at rest and protected with our IT security best practices.”
  • FEHBlog note: At least for HIPAA privacy rule purposes, an anonymous identifier cannot be based on an actual ID number as OPM plans. Moreover, to avoid re-identification, OPM should arrange for a third party to create the anonymous identifier properly and then arrange for the OIG to insert the anonymous identifier into the claims records before they are sent to OPM.
  • Per a Senate news release,
    • “Today the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted to favorably report several bills making health care more affordable and accessible to American families. During the markup, U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, led Republicans in rejecting Ranking Member Bernie Sanders’ (I-VT) attempt to sabotage the bipartisan bills with toxic poison pill amendments.
    • “I understand why Americans are frustrated with Congress. If we want Congress to work, we have to make it work,” said Dr. Cassidy. “I want part of my legacy [to be] he tried to preserve the institution. But that is a responsibility of us all.”
    • “I appreciate my colleagues’ efforts and will continue to work with Republicans and Democrats to enact a pro-patient, pro-family agenda,” continued Dr. Cassidy.
    • “The Charlotte Woodward Organ Transplant Discrimination Prevention Act, Healthy Start Reauthorization Act, Stem Cell Therapeutic and Research Reauthorization Act, EARLY Act Reauthorization, Accelerating Access to Critical Therapies for ALS Act, and the Biosimilar Red Tape Elimination Act passed unanimously as amended in an en bloc vote. The Medication Affordability and Patent Integrity Act also passed in a 16-6 vote.”
  • The American Hospital Association News relates,
    • The Department of Health and Human Services June 17 announced it will provide more than $700 million in funding for initiatives on mental illness, addiction and homelessness. Funding opportunities include $96 million for the Safety Through Recovery, Engagement, and Evidence-based Treatment and Support Program, or STREETS; $223.1 million for comprehensive community-based behavioral healthcare programs; $238.6 million for the 988 Suicide and Crisis Lifeline; $80 million for substance use prevention, treatment and recovery initiatives; and more than $70 million for mental health services and support programs. 
  • Beckers Hospital Review tells us,
    • “The Trump administration has begun enforcing federal information-blocking regulations against healthcare organizations that fail to provide patients with access to and exchange of their electronic health information, Politico reported June 17.
    • “Thomas Keane, assistant secretary for technology policy at HHS, told the publication that the agency has stepped up enforcement of data-sharing requirements as part of broader efforts to improve healthcare accessibility and affordability.
    • “Congress directed HHS to address information blocking through the 21st Century Cures Act, which was enacted in 2016. Rules implementing the law were finalized in 2020, and penalties were established in 2024.” * * *
    • “We have started issuing notices of nonconformity to information blockers,” Mr. Keane said. “We’ve had people come back to us and tell us: ‘Yes, we were information blocking.’” Mr. Keane said healthcare organizations may have financial or competitive incentives not to share patient information, but federal law requires health information to be shared for the benefit of patients.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.
    • “Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”
    • “Generic baloxavir marboxil tablets may be used for:
      • ‘Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
      • “Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.”
  • MedPage Today adds,
    • “The FDA approved oral tebipenem pivoxil (Utebzi) as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), the agency announced on Wednesday.
    • “Tebipenem pivoxil is indicated for complicated UTIs, including pyelonephritis, caused by the susceptible microorganisms Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, in adults who have limited or no alternative oral treatment options.” * * *
    • “Tebipenem pivoxil should be available to U.S. patients by the end of 2026, GSK said.”
  • BioPharma Dive tells us,
    • “UniQure, the Netherlands-based biotechnology company, intends to formally ask the Food and Drug Administration to approve its for Huntington’s disease gene therapy now that the two parties are more aligned on the closely watched treatment.
    • “UniQure said Wednesday that, during a recent meeting, FDA staff agreed three years of data gathered from a key trial of the therapy would be enough to support an approval application. As such, the company expects to file one sometime between July and the end of September. The FDA has requested another trial be conducted to confirm the treatment’s effects and, according to the UniQure, the agency wants to make sure both sides see eye to eye on this study’s design before a marketing application gets submitted.”
  • The American Hospital Association News informs us,
    • “The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027. The FDA said the shortage is due to a manufacturing disruption and that clinical management adjustments may be required for patients needing a breast biopsy. Healthcare providers are recommended to conserve their use of stereotactic breast biopsy needles. The agency said that Hologic issued a customer letter Jan. 2 that said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk of metal and plastic particles being dislodged from the device during use.” 

From the judicial front,

  • Healthcare Dive reports,
    • “OhioHealth has reached a proposed settlement with state and federal regulators over allegations that the Columbus, Ohio-based system strong-armed insurers into anticompetitive contracts.
    • “The deal announced Tuesday voids problematic OhioHealth contracts and prevents the system from seeking such terms in the future, according to the Department of Justice.
    • “OhioHealth, which has maintained its contracting practices are legal, did not have to admit wrongdoing as part of the settlement. The system also will not pay any penalties or fines.”
  • Fierce Healthcare tells us,
    • “The Pharmaceutical Care Management Association has joined some of the nation’s largest pharmacy benefit managers in challenging Tennessee’s new law governing the industry.
    • “The Volunteer State’s new policy would prevent PBMs from also owning or being affiliated with pharmacies operating in the state. State lawmakers argue that the law would bring greater transparency and fairness to the market, particularly to support independent pharmacies.
    • “CVS Health, parent company of “Big Three” PBM Caremark, was the first to sue over the law in late May, with Express Scripts following suit late last week.”
  • The Wall Street Journal relates,
    • Luigi Mangione will mount a psychiatric defense at his New York state trial for the killing of UnitedHealthcare Chief Executive Brian Thompson, a judge said Wednesday.
    • During a hearing in state court in Manhattan, Judge Gregory Carro said the lawyers discussed the defense strategy at a sealed proceeding earlier this month. The judge said defense lawyers intend to argue that Mangione killed the insurance executive due to an extreme emotional disturbance at the time. * * *
    • The state trial of Mangione, 28 years old, is scheduled to begin on Sept. 8. A psychiatric defense would significantly alter the nature of the trial because his lawyers would acknowledge he killed Thompson, but argue he did it because he was emotionally disturbed. If a jury agrees with that argument, his murder charge would be downgraded to manslaughter, resulting in a shorter potential prison term.
    • Mangione faces headwinds at trial, including a journal found in his backpack that prosecutors will likely use to argue that he planned the murder for months. “Extreme emotional disturbance is about a loss of self-control for which there was a reasonable explanation or excuse,” said Gary Galperin, a former prosecutor in Manhattan who now teaches at Cardozo School of Law. “The classic case is, you come home and find your spouse in bed with someone else.”

From the public health and medical / Rx research front,

  • The University of Minnesota’s CIDRAP reports,
    • “During the most recent respiratory virus season, the risk of hospitalization was higher for influenza than for COVID-19, per a US Department of Veterans Affairs (VA) study of nearly 13,000 patients.
    • “The authors, from the VA Saint Louis Health Care System, noted that while COVID-19 was tied to a substantially greater risk of hospitalization than flu early in the pandemic, data showed an increase in flu cases and hospitalizations in 2025-26 compared with previous seasons.
    • “The findings were published last week in The Lancet Infectious Diseases.
    • “However, population-level metrics reflect both infection frequency and disease severity and cannot alone determine the relative clinical severity of one pathogen versus another,” they wrote. “A head-to-head comparison of hospitalisation risk among infected individuals—which isolates disease severity from differences in infection frequency—has not been undertaken for the 2025–26 influenza season.”
  • Health Day relates,
    • “Folks are told that once you start taking Ozempic or Zepbound, you’ll need to stay on them to maintain the drugs’ benefits.
    • “But patients prescribed such GLP-1 drugs are more likely to stop them and then restart use later than was previously assumed, according to research presented Sunday at the Endocrine Society’s annual meeting in Chicago.
    • “We found that about 4 in 10 patients stopped their GLP-1 medication within the first year, and nearly 6 in 10 had stopped by the end of two years,” based on insurance records from more than 60,000 Americans with type 2 diabetes, said study investigator Sainikhil Sontha. He’s a research associate at Boston University School of Public Health.
    • “However, not everyone who stopped taking their GLP-1 remained off it.
    • “More than half of those who stopped restarted therapy within a year (42%), and nearly two-thirds did so within two years (58%),” Sontha said in a university news release. “This suggests that for many patients, these medications aren’t being abandoned permanently; use is more start-and-stop than most people assumed.”
  • and
    • Solid organ transplant survival is improving, but organ shortages persist, according to a study published in the July issue of the Journal of the American College of Surgeons.
  • and
    • “At-home blood pressure monitoring can lower risk of heart attack and stroke
    • “People participating in a remote monitoring program had a 34% lower risk of heart attack, stroke and heart disease
    • “Their readings were forwarded to a doctor, who kept tabs on their blood pressure.”
  • The Washington Post lets us know,
    • “As a doctor, I tell people to do these 4 things to reduce age-related muscle loss
    • “Resistance training, protein and recovery remain the most powerful tools for preserving strength and independence later in life.”
  • The latest NIH Research Matters covers the following topics:
    • Immune system may attack nervous system in some Long COVID patients
      • “Researchers linked antibodies that attack the body’s nervous system to some neurological symptoms of Long COVID.
      • “The results may point to possible treatments for some people with Long COVID.”
    • Depression screening using video games
      • “A study suggests that the unconscious way the brain assesses rewarding experiences is miscalibrated in patients with depression. 
      • “Game-like tasks to measure this mechanism could help doctors screen patients more quickly for depression.”
    • AI tool could speed antibiotic development
      • “Researchers developed and tested a system to improve the antibacterial effects of existing compounds.
      • “This system could help quickly create new antibiotics to overcome antibiotic resistance.”

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

  • The Wall Street Journal delves into state of the U.S. healthcare business.
  • Beckers Hospital Review ranks 40 health systems based on their first quarter 2026 operating margins, and tells us,
    • “Nashville, Tenn.-based Ascension Saint Thomas has broken ground on a $148.5 million hospital and healthcare campus in Clarksville, Tenn., expanding its presence in one of the state’s fastest-growing regions. 
    • “The 96-acre campus will include a full-service hospital that will open with 44 inpatient beds and expand to 132 beds as demand grows. The hospital will be St. Louis-based Ascension’s 19th in Tennessee, according to the health system’s website. 
    • “The hospital will offer emergency care, inpatient surgery, cardiology, neurosciences, women’s health, neonatal intensive care, oncology and orthopedic services. The broader campus will also feature physician offices, an inpatient rehabilitation hospital, outpatient surgery, advanced imaging and specialty ambulatory care services.”
  • BioPharma Dive informs us,
    • “Jazz Pharmaceuticals is enlisting the help of AbCellera in a bid to develop next-generation T-cell-engaging medicines to treat solid tumors.
    • “As part of a deal announced Wednesday, Jazz will pay AbCellera $56 million up front in exchange for discovery work and early-stage preclinical research on two programs. AbCellera also committed to start a third discovery program within 12 months, which will trigger another $28 million payment, and may undertake two additional projects if both companies agree.
    • “If Jazz exercises options for development, AbCellera could earn as much as $792 million more per program in fees and payments for reaching certain development, regulatory and commercial milestones. AbCellera would also be eligible for royalties, should any approved medications come out of the collaboration.”
  • Fierce Healthcare points out,
    • “Fitness wearable company Whoop announced Wednesday a partnership with health platform HealthEx that allows users to connect their medical records directly within the Whoop app, combining medical history with biometric data.
    • “The companies say the partnership “responds to a growing need” for “more connected health experiences” for users. The new integration allows various factors—such as chronic conditions, recent procedures and more—to be considered alongside tracking metrics, like performance and sleep. 
    • “Whoop has always focused on turning data into meaningful insights,” said Alex Vannoni, Whoop’s head of healthcare product, in a statement. “This partnership extends that approach by bringing medical history into the Whoop experience, giving members a more complete view of their health and enabling even more personalized, relevant coaching, grounded in who they are, not just what happened on a given day.”
    • “The integration is enabled by the Whoop AI and My Memory features. The artificial intelligence-driven My Memory feature, announced last month, allows users to provide context to manage personalized coaching.”
  • Beckers Payer Issues notes,
    • “Payers often work with employers, but they have to keep their own staff happy, too. 
    • “Amid a climate of payers across the country cutting jobs, Centene recently confirmed it is offering buyouts to most employees as its ACA business contracts. Against that backdrop, employee morale and retention have become pressing priorities for health plan leaders.
    • “Becker’s spoke with Sidecar Health’s chief people officer, Alex Coonce, and Elevance Health’s chief human resources officer and executive vice president, Ryan Craig, to learn about the biggest concerns for today’s health plan employees — and how each company is tackling them.”

Monday Report

David Ermer–ACA, CMS, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NIH, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“In her 1789 book The Female Reader, writer and philosopher Mary Wollstonecraft wrote: “Simplicity and sincerity generally go hand in hand, as both proceed from a love of truth.” (Source: https://tinyurl.com/4fzesrp4)

From Washington, DC,

  • Per an HHS news release,
    • “U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. launched GetActive.gov, a new national resource to help Americans improve their health through movement, fitness, outdoor recreation, and active living, during a series of “Take Back Your Health” tour stops across Colorado.
    • “Secretary Kennedy joined Secretary of the Interior Doug Burgum in Grand Junction to announce the initiative and highlight the Trump Administration’s efforts to expand access to public lands and outdoor recreation opportunities. He then visited Fort Carson to see firsthand how the Army is improving nutrition for servicemembers through its campus-style dining modernization program. The Secretary also toured InnovAge in Thornton, where he met with caregivers and seniors participating in the Program of All-Inclusive Care for the Elderly (PACE).
    • “The key to reversing America’s chronic disease epidemic is empowering people to take back their health,” Secretary Kennedy said. “We are helping people Get Active, Eat Real Food, and Live Real Life. From our public lands to our military bases to our senior care centers, these Colorado visits show how we are putting Make America Healthy Again into action.”
  • The American Hospital Association News reports,
    • “The Medicaid and CHIP Payment and Access Commission June 15 released its June 2026 report to Congress. Among the topics discussed, chapter two focuses on automation in Medicaid prior authorization and makes recommendations to improve oversight and increase disclosure and transparency of managed care plans’ use of automation in PA. The third chapter includes recommendations to improve managed care plan accountability. Chapter seven examines Medicaid provider enrollment and managed care credentialing processes and highlights challenges that have effects on provider participation and state administrative burden.”
  • and
    • “The Centers for Medicare & Medicaid Services and the Department of Health and Human Services issued a request for information June 12 seeking input on CMS’ review of the Affordable Care Act’s Essential Health Benefits framework and the requirement that the scope of EHBs is equal to the scope of benefits provided under a standard employer plan. Specifically, CMS is seeking comments on current interpretations of EHBs, state approaches to selecting and updating EHB-benchmark plans, methodologies to determine the scope of benefits included as EHBs, and how those approaches relate to access and market stability under the ACA. The agencies said the information will impact CMS’ evaluation on whether revisions or additions to current EHB regulations would be appropriate. Comments are due by July 15.”
  • BioPharma Dive relates,
    • “New under-the-skin injections of the cancer immunotherapies Keytruda and Opdivo would be subject to Medicare price negotiations at the same time as their intravenous counterparts under a proposed federal rule published Friday.
    • “The Centers for Medicare and Medicaid Services said the rule would close a “loophole” that allows drugmakers to extend the patent-protected life of blockbuster drugs, commonly called “evergreening.” However, Medicare could exempt the newer formulation from its price ceiling should biosimilars of the IV version enter the market and compete on price.
    • “The rule could most immediately affect Keytruda maker Merck & Co. and Opdivo developer Bristol Myers Squibb, along with Halozyme, which developed the delivery technology that helped Opdivo and Johnson & Johnson’s Darzalex transition from IV to subcutaneous shots. Halozyme, however, said it forecasts “zero to minimal impact to its royalty revenues through at least 2035.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “The Food and Drug Administration said Monday that it will allow Colorado to import certain prescription drugs from Canada in an effort to bring prices down for residents, making it the second U.S. state to be granted such authorization. 
    • “For more than a quarter of a century, Americans have sought drugs from Canada for relief from the ever-rising costs of medicines, sometimes taking widely publicized bus trips across the border. It wasn’t until 2020, though, that the first Trump administration officially endorsed the practice, when it published a regulationallowing states and Indian tribes to propose import plans. The Biden administration affirmed this rule with an executive order in 2021. And Florida became the first state to earn FDA approval in 2024. 
    • “But state importation programs have proved extremely difficult to carry out, even with bipartisan support. Florida has yet to actually import any drugs from Canada, in part due to pushback from the Canadian pharmaceutical industry and fears the program will affect Canada’s drug supply. In May, the FDA extended its approval by six months to give the state more time to get its program up and running.”
  • Fierce Pharma relates,
    • “Despite prior concerns from the FDA, a regimen involving AstraZeneca’s AKT inhibitor Truqap (capivasertib) has passed muster in a specific population of prostate cancer patients. 
    • “Late last week, the U.S. regulator signed off on Truqap plus Johnson & Johnson’s Zytiga (abiraterone) and prednisone to treat adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer—the indication previously known as metastatic hormone-sensitive prostate cancer—that is determined to be PTEN-deficient.
  • and
    • Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook. 
    • The June 12 FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery. Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex. 
    • With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC, marking an “important step in addressing the needs of patients with earlier-stage renal cell carcinoma,” kidney cancer advocacy group KidneyCan’s CEO and co-founder Bryan Lewis noted in a Merck press release. 
  • Cardiovascular Busines tells us,
    • “Penumbra, a California-based medtech company known for its vascular technologies, has received U.S. Food and Drug Administration (FDA) clearance for a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.
    • “According to Penumbra, Thunderbolt represents the first CAVT device approved in the United States for the treatment of stroke. It is powered by Penumbra’s Engine technology and uses modulated aspiration to “detect, fatigue and completely ingest” blood clots at the site of occlusion. Thunderbolt will be sent to customers prepackaged with one of the company’s catheters.”
  • MedPage Today tells us,
    • “The FDA cleared medical-grade Australian sheep blowfly (Lucilia cuprina) larvae in what maker Cuprina Holdingsopens in a new tab or window believes marks the first debridement product to use this particular species.
    • “Dubbed Medifly Maggots, the product is indicated for removing dead or infected tissue from non-healing necrotic skin and soft tissue wounds — such as pressure or neuropathic foot ulcers — and non-healing traumatic or post-surgical wounds.
    • “A healthcare worker is required to oversee the application of the prescription maggot product, which was cleared based on demonstration of equivalence to the previously cleared medical-grade green bottle blowfly larvae — Lucilia sericata (Medical Maggots).”

From the judicial front,

  • Healthcare Dive reports,
    • “A federal judge has struck down key provisions in a CMS rule overhauling the Affordable Care Act, in a setback for the Trump administration’s push to combat fraud that critics argue is a smokescreen for weakening the exchanges set up by the Obama-era law.
    • “On Friday, Judge Brendan Hurson of the Maryland District Court vacated eight of the rule’s most consequential provisions, including the creation of a $5 premium penalty for individuals who automatically reenroll in coverage and a policy disqualifying people who fail to reconcile tax credits with their income from receiving subsidies.
    • “The decision is not a surprise after Hurson stayed most of the provisions last year. Still, officially tossing them out is a victory for proponents of expanded ACA coverage — though a short-term one, given many of the changes were codified in the GOP’s “Big Beautiful Bill” passed last summer.”

From the public health and medical / Rx research front,

  • STAT News reports,
    • “A pregnant woman in rural Arizona with syphillis could have been treated fairly easily with an injection of penicillin. But the drug, Bicillin L-A, is manufactured only by Pfizer, and has been in short supply for a year now — which meant the drug arrived too late to prevent probable congenital syphilis in her newborn.
    • “The syphilis epidemic is worsening, congenital syphilis cases are up roughly 800% since 2012 — and this Bicillin shortage is expected to continue through 2027. Public health officials say Pfizer’s emergency allocation system is confusing and may disadvantage health departments serving low-income patients.
    • “A box of 10 syringes can cost around $8,000, and the drug is manufactured at only one Pfizer plant in Michigan to supply the whole country.
    • “Most shortages are of not-very-profitable drugs,” said Erin Fox, associate chief pharmacy officer at University of Utah Health.”
  • The American Medical Association lets us know what doctors want patientsto know about allergic rhinitis
    • “Allergic rhinitis, or hay fever, is more than just the sniffles. Understanding triggers and when to talk to a physician are key to managing allergic rhinitis.”
  • Per an National Institutes of Health news release,
    • “A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions.
    • “Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.”
  • MedPage Today relates,
    • “COVID-19 vaccines were associated with a lower risk of major adverse cardiovascular events in “a cohort study of veterans.
    • “The 2024-2025 vaccines also demonstrated effectiveness against COVID-associated emergent care, hospitalization, and critical illness among adults.
    • “Among older adults who received a 2025-2026 vaccine, overall COVID vaccine effectiveness against symptomatic disease was 59%.
  • Healio tells us,
    • “Less than a quarter of patients with stroke and fewer than one in seven with traumatic brain injury were discharged to inpatient rehabilitation.
    • “Clinicians should plan for rehabilitation early and make it an intentional part of care.”
  • and
    • “The American College of Physicians (ACP) has published living clinical guidance to help physicians select medications for patients with overweight or obesity.
    • “Unhealthy weight remains a significant public health issue globally, with 68.5% of American adults and 59% of adults worldwide having overweight or obesity, according to Amir Qaseem, MD, PhD, MHA, MGIN, MRCP, FACP, ACP chief science officer and senior vice president of clinical policy at the Centers for Evidence Reviews, and colleagues.
    • “They wrote in Annals of Internal Medicine that first-line treatments for obesity and overweight include physical activity and nutrition, but the new guidance “addresses additional management using pharmacologic treatments when lifestyle modifications alone do not result in optimal weight loss or weight maintenance for a person.”
  • Pharmacy Times informs us,
    • “Pooling ATTAIN-1/2 female participants, menopausal stage–stratified outcomes at 72 weeks included weight, waist circumference, waist-to-height ratio, and categorical weight-loss thresholds using an efficacy estimand. 
    • “Orforglipron [Lilly’s oral GLP-1 drug] achieved statistically significant placebo-adjusted reductions across premenopause, perimenopause, and postmenopause, reaching approximately 14% body-weight loss and up to 11 cm waist reduction (P<.001). 
    • “Clinically meaningful responder rates favored orforglipron, with up to 83% achieving ≥5% weight loss vs 23% on placebo, and higher rates across ≥10%, ≥15%, and ≥20% thresholds. 
    • “More participants shifted to lower waist-to-height ratio categories on active therapy, supporting potential visceral adiposity and cardiometabolic risk mitigation in menopause-associated fat redistribution. 
    • “Unrestricted oral administration (no food/water requirements) may reduce adherence barriers in midlife women with polypharmacy, strengthening pharmacist-led counseling and referral pathways in obesity care.”
  • BioPharma Dive points out,
    • “An experimental drug that Eli Lilly recently picked up through a potentially multibillion-dollar acquisition appears to have passed its first major test, scoring positive results in a small study of patients with hard-to-treat blood cancer.
    • “Originally developed by Ajax Therapeutics, the drug inhibits an enzyme that spurs blood cell production. Several medicines that block this “JAK2” enzyme, including Incyte’s Jakafi, are already on the market, where they’re mostly used in rare, chronic blood cancers like myelofibrosis. While these medicines can be quite effective at treating symptoms, many patients either don’t respond or stop taking them because their disease progresses or they can’t tolerate the side effects, which range from nausea and fatigue to anemia and increased stroke risk.
    • “Lilly’s pill is designed to work in a slightly different way than its approved counterparts, binding to JAK2 in the “inactive” state. Researchers hypothesize this change should make for a superior therapy that also overcomes drug resistance challenges.
    • That idea now has more support thanks to data presented over the weekend at a major medical meeting in Europe.”

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

  • Beckers Payer Issues reports,
    • “Health Care Service Corp. will launch a new line of commercial health plans called Edge across all five of its Blue Cross Blue Shield states beginning in 2027.
    • “The plans, powered by a proprietary plan design called Easify, have no deductibles and no coinsurance for in-network care, leaving members with fixed copays, according to a June 11 news release. 
    • “HCSC said the PPO plans aim to let employees in Illinois, Texas, Oklahoma, Montana and New Mexico anticipate out-of-pocket costs more easily and help employers better manage total medical spend. HCSC also said the new product will steer members toward “high-value” care using behavioral incentives.” 
  • Beckers Hospital Review relates
    • “Middle-age adults who use GLP-1 medications for obesity could save an average of $192,735 in lifetime medical costs, according to a study published in June by the National Bureau of Economic Research. 
    • “Researchers from Los Angeles-based University of Southern California simulated health and economic outcomes for U.S. adults ages 25 and older, comparing lifetime trajectories for people who used GLP-1s for obesity with those who did not. Obesity was defined as a body mass index higher than 30.”
  • and
    • “Virtual nursing for hospital discharge was associated with sharply lower 30-day emergency department readmissions across nine hospitals in a major Southeastern U.S. health system, according to a study published in npj Digital Medicine.
    • “Researchers at the University of North Carolina at Chapel Hill compared 4,662 discharges handled by remotely located virtual nurses with 4,662 traditional in-person discharges, matched on patient and hospital characteristics. Patients discharged through virtual nursing returned to the ED within 30 days at a rate of 3.7%, versus 13.3% for in-person discharge — a 72% relative reduction, or a risk ratio of 0.28. That works out to roughly 1 readmission in 27 virtual-nursing patients, compared with 1 in 8 receiving standard discharge.
    • “The effect held in both settings, with the gap widest in rural hospitals: 3.1% versus 17.9% rural, and 4.1% versus 10.7% urban.
    • “Virtual nurses delivered structured, uninterrupted discharge education — medication reconciliation, teach-back, and care-plan review — from an off-site center operating 7 a.m. to 7 p.m., seven days a week. The health system rolled out the model across the nine hospitals between 2022 and 2024.”
  • MedTech Dive informs us,
    • “Medtronic said Friday it has completed the $550 million takeover of neurovascular technology company Scientia Vascular.
    • “The deal, which Medtronic disclosed in March, covers guidewire technologies for stroke that are designed to equip physicians to access hard-to-reach parts of the brain.
    • “Buying Scientia will enable “every neurovascular procedure to start with Medtronic,” CEO Geoff Martha said on an earnings call with investors this month.”
  • Medical News Today points out,
    • Three AI-based mammography systems were able to identify subtle signs of future breast cancer years before diagnosis, with elevated cancer prediction scores seen in those who later developed the disease. 
    • In the study, approximately 20% of breast cancer cases showed AI-detectable mammographic changes as early as 6 years before diagnosis. 
    • At 90% specificity, the AI systems flagged potential future cancers in up to 19.7% of women 6 years before diagnosis, 25.2% 4 years before diagnosis, and 39.3% 2 years before diagnosis. 
    • The findings suggest AI could support earlier breast cancer detection and help enable more personalized screening strategies by identifying females who may benefit from closer monitoring or earlier intervention.
  • FYI, The Blue Cross Blue Shield Association has a job opening on its Legal Team supporting FEP.

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

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

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”

Tuesday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • The House [of Representatives] passed a Republican-led $70 billion immigration-enforcement bill Tuesday, ending a monthslong stalemate over the slice of federal spending, and funding the contentious operations through the rest of President Trump’s second term.
    • The bill, which passed 214-212, comes after the Senate narrowly cleared funding for the agencies last week, using a special budget process that allowed Republicans to bypass the 60-vote threshold for most bills. Congress had approved funding for most of the Department of Homeland Security earlier this year, but Democratic opposition had held up money for Immigration and Customs Enforcement and Border Patrol. Trump is expected to sign the measure into law.
  • Healthcare Dive relates,
    • “A key House panel voted unanimously Tuesday to end a pilot program testing prior authorizations in fee-for-service Medicare.
    • “The House Appropriations Committee approved legislative language that would bar the Centers for Medicare and Medicaid Services from spending money to implement the Wasteful and Inappropriate Service Reduction Model, or WISeR, which the agency launched in six states this January. This provision was amended to a bill to fund the Health and Human Services Department in fiscal 2027, which the panel is still considering.”
    • Providers have blasted WISeR, a six-year demonstration that is partly reliant on artificial intelligence and is being managed by technology companies. 
    • The HHS appropriations bill must clear more hurdles, including advancing out of committee, passing the House and being reconciled with the Senate’s pending version of the spending package, before the WISeR provisions would become law.
  • Govexec tells us,
    • “Rep. Raja Krishnamoorthi, D-Ill., on Tuesday said the Trump administration’s recently unveiled plan to make federal employees sign a non-disclosure agreement “threatens” the federal workforce’s constitutional rights and creates a chilling effect on would-be whistleblowers and demanded information into how it was developed.
    • “Last month, the Office of Personnel Management formally proposed requiring all federal employees to sign NDAs barring them from divulging “confidential” information in most cases, prompting swift outcry from civil service groups and employment lawyers. A draft copy of the document bars signatories from disclosing information related to internal agency operations, personnel and procurement matters and “any sensitive, pre-decisional or deliberative material.”
    • “In a letter to OPM Director Scott Kupor, the Illinois Democrat criticized the proposal as “over-broad” and likely to make it more difficult for whistleblowers to divulge allegations of waste, fraud and abuse.” * * *
    • “The Democrat demanded information on OPM’s legal analysis of whether the proposed NDA comports with the First Amendment and the Whistleblower Protection Act, a definition of “confidential” for the purposes of the document, as well as any potential consequences federal employees who refuse to sign the agreement would face, and whether it would apply equally to both career employees and political appointees.”
  • Federal News Network discusses “OPM[‘s] details [about] changes for federal employees in Schedule Policy/Career.”
    • “As agencies gear up for implementation, OPM detailed what Schedule Policy/Career will mean for recruitment, adverse actions and other personnel policies.” * * *
    • “Implementation instructions for agencies on Schedule Policy/Career are now available in guidance that the Office of Personnel Management published Monday.” 
  • The Government Accountability Office issued a report titled “Federal Workforce: Executive Actions Reshaped Probationary Employment Rules and Reduced Staff Levels at Selected Agencies.”
    • “Since January 2025, in response to presidential directives and accompanying Office of Personnel Management (OPM) guidance, many federal agencies have taken steps to reduce their probationary and trial employee staffing levels. These are employees who have not yet completed the service requirements necessary to finalize their appointments, either after being newly hired or after being appointed as a supervisor or manager. Probationary periods are generally 1 or 2 years during which probationary and trial employees have limited job protections.” * * *
    • “GAO’s analysis of OPM’s Federal Workforce Data (FWD) found that, in 2025, probationary employees separated from 11 selected agencies at a slightly higher rate (19 percent) compared to all employees who separated from these agencies (15 percent). Over two-thirds of these separating probationary employees did so voluntarily as did all employees who separated from these agencies.
    • “Across most selected agencies in 2025, a greater proportion of probationary employees separated compared to all employees who separated. At the Department of Energy, for instance, about 34 percent of probationary employees separated, compared with 19 percent of all employees. The Department of Defense recorded the largest number of probationary separations—about 20,000 employees—but separation rates for probationary employees and the overall Defense workforce were nearly identical, at about 14 percent.”
  • The Wall Street Journal lets us know,
    • “Social Security is expected to deplete the fund that helps pay out retirement benefits by late 2032, the program’s trustees said Tuesday.
    • “That is earlier than their projection last year of 2033, partly because the fund expects to collect less revenue after President Trump’s new tax law. Passed last summer, the law gave senior citizens an extra deduction that reduced taxes on benefits for many Social Security recipients. 
    • “Revenues are also shrinking because declining fertility rates and immigration are reducing tax revenue by cutting the number of workers paying into the system, according to the trustees.
    • “The trustees reduced their long-term expectations for fertility rates on Tuesday, indicating they will remain lower for longer than previously projected.” * * *
    • “Unless Congress shores up the retirement program, the depletion of reserves would trigger a 22% reduction in benefits in late 2032. Because incoming payroll tax revenue doesn’t fully cover promised benefits, the program is forced to make up the difference by pulling money from its two Social Security trust funds—one for disability benefits and the other for the larger program for retirees.
    • Congress could temporarily use money from the disability trust fund to prop up the retirement fund. But that is a short-term solution because on a combined basis, the two funds are projected to become insolvent in the third quarter of 2034, according to the trustees.” * * *
    • “To shore up the system, lawmakers could borrow more, raise taxes, reduce benefits or reach an agreement that combines those measures.”
  • Fierce Healthcare points out,
    • “More than 500 hospitals falling short on price transparency requirements have received warnings from the federal government since April, with more “likely” to receive similar notices soon, the AP reported Tuesday morning. 
    • “The outlet’s report cited an unnamed “senior administration official” who shared a list of 519 nationwide hospitals that recently received either a warning notice or a Corrective Action Plan (CAP) request. 
    • “The former is an initial 90-day warning from the Centers for Medicare and Medicaid Services with instructions to correct any deficiencies, while the latter is a subsequent 45-day deadline for a hospital to submit a more concrete plan to address its compliance deficiencies. 
    • “For hospitals that do not come into compliance following these, CMS issues a civil monetary penalty that scales with bed count. These can run as high as $5,500 per day, or over $2 million per year. Twenty-eight hospitals have been issued civil monetary penalty notices to date, according to CMS.
    • “Among the list of warned hospitals obtained by the AP, Texas led other states with 42 notified facilities, followed by 38 in California, 34 in Indiana and 27 in Louisiana.” 
  • The American Hospital Association News notes,
    • “The Department of Health and Human Services June 8 released a request for information on research, policy and strategies to improve addiction and mental illness prevention, treatment and recovery. HHS said it it seeks to identify successful initiatives, recommend novel policy ideas and address research gaps. Comments are due to HHS by July 5.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
    • ““As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
    • “FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
    • “Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
    • “The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones. 
    • “Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “[M]illions of Americans [suffer] with cardiovascular-kidney-metabolic syndrome, a disorder defined in 2023 by the American Heart Association. It describes a cluster of conditions—heart disease, diabetes, kidney disease—that have common risk factors and fuel one another. Long treated as isolated or individual diseases, the conditions are interrelated, usually tied to excess abdominal fat, and a major driver of heart disease, according to the AHA.
    • “On Tuesday, the AHA and three other medical societies published the first guidelines to help clinicians prevent and manage CKM, as it is called, urging them to focus on their patients’ overall metabolic health. The goal is to prevent or slow the progression of conditions that may ultimately lead to heart attacks and strokes, which are becoming more common in younger adults.
    • “The new guidelines call for doctors—from primary care to cardiology—to screen patients for metabolic risk factors and kidney function routinely. Risk from excess fat should be measured both by body-mass index (BMI) and waist circumference, according to the new guidelines, which were developed by the AHA and the American College of Cardiology with the American Diabetes Association and American Society of Nephrology.
    • “In the 1970s, smoking, high blood pressure and cholesterol were the classic risk factors for heart disease, said Dr. Chiadi Ndumele, chair of the committee that wrote the new guideline and a preventive cardiologist at Johns Hopkins University School of Medicine. Today, excess abdominal fat is a major risk factor because it can trigger chronic inflammation that damages arteries, cardiac tissue and kidneys, he said.”
  • The New York Times relates,
    • “A government alcohol study published on Tuesday concluded that the health risks of alcohol start at a single drink a day. The report was caught up in controversy after drawing the ire of the alcohol industry.
    • “At one drink a day, the researchers found, there was an increased risk of premature death from an illness or injury directly attributable to alcohol, though it was small — one in 1,000 people. But the risk of premature death jumped to one in 25 for those who had two drinks a day, a level long considered safe for men, according to the study, which was published in the Journal of Studies on Alcohol and Drugs.
    • “The Alcohol Intake and Health Study was one of two reports commissioned during the Biden administration to inform an update to the U.S. dietary guidelines.
    • “The second report, from a panel appointed by the National Academies of Sciences, Engineering and Medicine, or NASEM, came to very different conclusions. It suggested that moderate drinking (up to two drinks a day for men and one for women) was healthier than not drinking at all, although it noted that moderate drinking was also linked to a higher breast cancer risk. Some of the panelists behind that report had financial ties to the alcohol industry.”
    • * * * “One reason the studies reached such different conclusions is that while the new study examined deaths from causes directly attributable to alcohol, the NASEM report commissioned by Congress looked at overall death rates of moderate drinkers, including deaths not causally related to alcohol.
    • “Critics of the NASEM report say that people who drink in moderation often have other healthy lifestyle habits that contribute to their longevity. The moderate drinking group also included many people who consumed less than two drinks a day. Both of these factors could make the health effects of moderate drinking look less significant than they might be.
    • “Dr. Ned Calonge, an epidemiologist at the University of Colorado Anschutz Medical Campus who led the NASEM study, said he stood by its conclusions.
    • “Alcohol research is complex and I am not surprised by different methods producing different results,” Dr. Calonge said, adding that modeling studies like the Alcohol Intake and Health Study, which use data to estimate the lifetime risk of diseases and deaths caused by alcohol, also come with potential biases.
    • “At the same time, he added “I don’t believe anyone should start drinking for health reasons.”
  • and
    • “The U.S. Department of Agriculture announced three new cases of New World screwworm, including the first cases in dogs and goats, on Monday, bringing the nation’s total case count to five. It also pledged to ramp up and expedite mitigation efforts for screwworm, a parasitic fly that the nation declared eradicated in the 1960s.
    • “At a news briefing on Monday, federal and Texas state officials said that they were using technology driven by artificial intelligence to monitor screwworm populations, training ranchers to recognize infections in their livestock and expanding the number of facilities that produce and disperse sterile flies, which are the primary tool for managing screwworm.
    • “Officials are also considering whether to grant an emergency authorization of a new, genetically engineered strain of flies that could make sterile fly production faster and more efficient.
    • “We prevented and eradicated this pest before,” Gov. Greg Abbott, Republican of Texas, said during the briefing. “We can do it again.” * * *
    • “The New World screwworm is a blowfly that feeds on living flesh. Adult females lay their eggs in open wounds or orifices of warm-blooded animals. When the eggs hatch, the larvae burrow into the wound, consuming the animal’s tissue. Untreated, screwworm infections can kill animals within a week.
    • “In humans, screwworm infections are rare. Last year, American health officials confirmed a travel-related case in a Maryland resident who had recently traveled to El Salvador, but no domestically acquired human cases have been reported yet.”
  • Health Day adds,
    •  There’s a biological reason why booze makes a person crave bar snacks like chips, nuts, fries and pizza, a new study argues.
    • Alcohol appears to trigger a hormone associated with cravings for savory flavors, researchers reported recently in the journal Obesity Reviews.
    • This hormone, FGF21, is linked to protein appetite and, when activated, can shift cravings toward salty, umami-flavored foods, researchers found.
    • “Many people will recognize the experience of having a few drinks and suddenly craving something salty, like chips, French fries, pizza or other savory foods,” said lead researcher Amanda Grech, a research associate at the University of Sydney’s Charles Perkins Center.
    • “Now we have a better understanding of the hormonal dynamic at play, which may be driving overconsumption of ultra-processed foods,” Grech said in a news release.
  • Cigna Healthcare, writing in LinkedIn, discusses “Men’s Mental Health Awareness Month [meaning this month]: Making Room for What Men Carry—At Work and Beyond.”
    • “Men’s Mental Health Awareness Month is an invitation to redefine strength as something sustainable: self-awareness, early help-seeking, and staying connected under pressure. In any workplace, the most meaningful shift isn’t a grand statement—it’s a steady message, reinforced over time, that dignity comes first and support is not something you have to earn. When men are met with respect, privacy, and real permission to be human, it becomes easier to speak earlier, connect more honestly, and get care before strain becomes a crisis.”
  • MedPage Today tells us,
    • “While the American Academy of Pediatrics now recommends introducing certain allergenic foods by ages 4-6 months for all children, guidelines from the 1990s and 2000s had recommended delaying introduction until 1-3 years.
    • “As the proportion of infants introduced to egg by 6 months of age increased from 2007-2011 to 2018-2019, egg allergy prevalence adjusted for changes in known allergy risk factors fell from 9.2% to 7.6%.
    • “Infants with early-onset eczema saw the biggest impact, with egg allergy prevalence decreasing from 34.6% to 21.9%.”
  • and
    • “Respiratory tract infections (RTIs) continue to be a substantial cause of mortality in children under 5 and contribute to morbidity, hospitalizations, and healthcare costs.
    • “Nearly one in four of the current study’s hospitalized pediatric patients with acute RTIs developed severe disease.
    • “Increased risk was highest in kids with two or more underlying conditions or who were transferred from a referring hospital.”
  • The National Institutes of Health’s Reseach in Context considers “Understanding the exposome.”
    • “Tracking how the environment affects health
    • “The world around us influences our health in countless ways. This special Research in Context feature explores how scientists are using new technologies and approaches to measure the exposome—the total set of environmental exposures people encounter throughout life and their biological response to them.
  • Genetic Engineering and Biotechnology News points out,
    • “When Jingkun Zeng, PhD, joined the lab of Nobel laureate, Jennifer Doudna, PhD, as a postdoctoral researcher in 2024, he was not interested in applying CRISPR for gene editing. 
    • “The molecular scissors had demonstrated extraordinary clinical promise in correcting single-point mutations, most strikingly in Baby KJ’s case, where a rare metabolic disorder once presented a 50% mortality rate in infancy. 
    • “Yet, Zeng had his ambitious sights on stopping cancer progression, where the biology “became messy.” Cancer can be driven by hundreds of thousands of mutations, making it nearly impossible to correct each mutation one-by-one to restore healthy function. 
    • “Zeng, who completed his PhD training in cancer evolution at The Francis Crick Institute, aimed to develop new CRISPR-based technology that could therapeutically access the undruggable tumor suppressor protein, p53. Mutations in this “guardian of the genome” are found in nearly half of all cancers, and up to 70–90% of cases of the most deadly tumors, including ovarian, pancreatic, and non-small cell lung cancer. 
    • “In a new study published in Nature titled, “Targeting Cancer-Specific Mutations with RNA-Triggered Chromatin Shredding,” Zeng and colleagues from Innovative Genomics Institute (IGI), University of California (UC) Berkeley, UC San Francisco (UCSF), and Gladstone Institutes, have now engineered a CRISPR system to selectively trigger cancer cell death by chromatin shredding.  
    • “The approach recognizes cancer cells using the RNA-guided nuclease, CRISPR-Cas12a2, to recognizemutant p53 mRNA transcripts. Therapeutic effectiveness was demonstrated in mouse models of lung and liver tumors.” 
  • Per Fierce Pharma,
    • “A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.
    • “Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. 
    • “In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.”
  • and
    • “Following another phase 3 failure for Gilead Sciences’ Trodelvy, the race to bring a TROP2 antibody-drug conjugate (ADC) to patients with first-line non-small cell lung cancer (NSCLC) has narrowed. 
    • “Monday, Merck & Co. and Gilead announced that they are pulling the plug on the phase 3 Evoke-03 trial, also known as Keynote-D46, following the recommendation of an external data monitoring committee. 
    • “The study was evaluating Trodelvy, combined with Keytruda, as a first-line treatment in patients with PD-L1-high NSCLC versus Keytruda alone.” * * *
    • “Without a win in first-line NSCLC, Trodelvy’s commercial future will mainly depend on its triple-negative breast cancer uses, which won’t be able to justify the $21 billion price tag that Gilead paid for the med’s developer, Immunomedics. Gilead already took major write-offs tied to Trodelvy’s second-line NSCLC failure and a market withdrawal in bladder cancer in 2024.”

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

  • Fierce Healthcare reports,
    • “Health insurance executives convene this week in Las Vegas at a time when the industry is facing significant pressure on cost, access and policy changes.
    • “AHIP’s annual conference kicks off Tuesday morning, with two days of sessions and discussions that center on the major challenges facing insurers today, from new technologies to consumer engagement to rising medical costs.
    • “Fierce Healthcare will be on-site this week to provide key insights from the show floor, but before the conference opens, [the article offers] a look at some of the biggest themes to watch on the agenda.”
  • Beckers Hospital Review relates,
    • “Springfield, Mass.-based Baystate Health is planning to acquire a financially challenged hospital in the city from Hartford, Conn.-based Trinity Health of New England for $293 million through a member substitution valued at $293 million. 
    • “Baystate signed a definitive agreement in April to acquire Mercy Medical Center, a 182-bed acute care hospital, as well as Mercy’s joint ventures and affiliated medical groups from Trinity Health of New England, which is part of Livonia, Mich.-based Trinity Health. 
    • “As part of the regulatory approval process, Baystate is required to get a determination of need from the Massachusetts Department of Public Health. According to a filing with the department, MMC has experienced “significant and continued operating losses in recent years.”
  • and
    • “The American Medical Association’s House of Delegates voted to formally oppose use of the term “provider” when referring to physicians, adopting the new policy at its Annual Meeting in Chicago this week.
    • “The vote builds on existing AMA policy that already calls on healthcare entities to specify the type of clinician — using their recognized title and credentials — when using the term “provider” in contracts, advertising and other communications. It also directed AMA to prohibit use of the term in its own publications.
    • “The new policy goes further, directing the AMA to actively oppose the term when it encompasses physicians and to implement the existing policy’s external advocacy provisions, which had not yet been fully advanced.
    • “The AMA argues that the term “provider” undermines patient education, transparency and physician professionalism, and poses risks to patient safety by obscuring the distinctions among clinician types and their training, according to a June 9 news release.”
  • Radiology Business adds,
    • “The radiologist shortage is real, but it may be smaller and more local than previous reports might indicate, according to new research. 
    • “About 47% of “open” radiologist jobs are reposts of the same role. However, the “real shortage” appears to be “concentrated and stubborn,” according to an analysis shared by RadBoard, an artificial intelligence-powered platform for researching jobs in the specialty. 
    • ‘Approximately 1,470 of active radiologist openings have been sitting unfilled for over two months or more. 
    • “Most aren’t underpaid—they’re geographically inconvenient,” writes report author Kirill Lopatin, founder and CEO of xAID, which offers AI solutions to radiology groups.” 
  • The Wall Street Journal tells us,
    • GSK GSK [symbol]  agreed to buy U.S. cancer-drug developer Nuvalent NUVL for $10.6 billion, the British pharmaceutical company’s latest move to bolster its oncology business.
    • The acquisition is set to give GSK two drug candidates for lung cancer that are currently under review by the U.S. Food and Drug Administration as well as a third, earlier-stage medicine, the London-based company said Tuesday.
    • The deal comes as GSK works to rebuild its position in the market for cancer treatments, one of the most lucrative areas of the pharmaceuticals industry. GSK exited oncology in 2015 as part of a broader asset-swap deal with Switzerland’s Novartis. The company has since returned to the market with the acquisitions of Tesaro, Sierra Oncology and IDRx as well as licensing deals.
    • “Our strategy has been a brick-by-brick building approach,” GSK Chief Executive Luke Miels said, adding that the company would continue to look for further opportunities.
  • STAT News informs us,
    • “The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.
    • “For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.
    • “Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.”
    • “At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”
  • A commentator in Healthcare IT Today explains “The Emerging Role of AI Platforms in Healthcare Delivery: What Healthcare Leaders Need to Know.”
    • “With the launch of ChatGPT Health and Claude for Healthcare, AI has moved from the margins of healthcare IT to its center. It will define how patients engage with care and how clinicians deliver it.
    • “Participation is inevitable. Leadership is not. Organizations that act now will shape the future of care. Those that wait will inherit it.”
  • Fierce Healthcare adds,
    • “More than one-third of clinicians say artificial intelligence use is allowing them to see more patients, with a median of five additional patients per week, a new report from Philips found.
    • “The Future Health Index 2026 (PDF) drew insights from more than 2,000 healthcare professionals and more than 20,000 patients across 10 countries. 
    • “Nearly three-quarters (74%) of clinicians say their use of AI-enabled tools provided by their organization has increased over the past year. Among surveyed clinicians, 52% are using AI to transcribe clinical notes and close to half (46%) are using generative AI as a professional “buddy” to discuss work-related ideas. AI use is also growing for clinical decision support as 45% use AI tools to suggest diagnoses based on patient symptoms and 44% use AI-enabled tools to flag potential dangerous drug combinations.”
  • Per MedTech Dive,
    • “Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
    • “Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
    • “Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.” * * *
    • “People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.” 
    • “People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.”

Monday report

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

Simplicity is a virtue.

From Washington, DC

  • Roll Call takes a look at what’s ahead of Congress this week,
  • and also lets us know,
    • “President Donald Trump on Monday sent to the Senate the nomination of acting Attorney General Todd Blanche to fill the role permanently, teeing up what could be a bruising confirmation process for a Trump ally who has drawn bipartisan criticism for recent Justice Department moves.”
  • Per a HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education today hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce a historic development to increase nutrition requirements at every level of U.S. medical education, competency-evaluation, training, and residency. Additionally, 19 medical schools across the country have signed the Trump administration’s Nutrition Education Pledge, vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.
    • “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health,” said Secretary Robert F. Kennedy, Jr. “Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”
    • “Last August, HHS and the Department of Education sent a letter to medical organizations encouraging them to improve their standards and place nutrition at the core of their programs.”
  • Beckers Hospital Review informs us,
    • “TrumpRx.gov is adding 160 prescription drugs to the platform, bringing its total to more than 800  according to a June 5 Truth Social post from President Donald Trump.
    • “The president said the expansion would allow TrumpRx.gov to offer discounted pricing for medications that account for roughly four out of every five prescriptions filled in the U.S. The administration also claims the platform has saved American patients more than $400 million since its February launch.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced additional leading technology companies have committed to partnering with the US Tech Force (Tech Force), the government-wide initiative to recruit top technologists to modernize the federal government and strengthen America’s technical workforce.
    • “The new industry partners include Arista Networks, Armada, Cisco, Cognition AI, Cognizant, Payward, Moveworks from ServiceNow, Scale AI, and Wiz.
    • “These companies will contribute to Tech Force by providing technical training resources, executive engagement and programming, nominating employees for temporary government service, and helping create paths for Tech Force alumni into the private sector.” * * *
    • “More information about Tech Force is available here.”
  • The American Hospital Association News reports,
    • “The Drug Enforcement Administration today released a final rule implementing provisions from the Restoring Hope for Mental Health and Well-Being Act of 2022, which passed as part of the Consolidated Appropriations Act of 2023, eliminating the need for a separate waiver for qualified practitioners to dispense certain types of controlled substances for medications for opioid use disorder treatment, or MOUD. While the original requirements were amended by the SUPPORT Act of 2018 and changes were implemented in an interim final rule in 2020, the 2022 legislation struck the amended section from regulation, thus requiring DEA to respond to public comments on the interim final rule and update regulatory language accordingly.”

From the Food and Drug Administration front,

  • Fierce Pharma informs us
    • “The FDA has expanded the label for Pfizer’s subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.
    • “The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.
    • “The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.”
  • CBS News reports,
    • “Retatrutide isn’t supposed to be everywhere.
    • “Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
    • “It isn’t just shadowy online vendors offering what they claim to be research-grade retatrutide.
    • “A CBS News investigation found dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, openly advertising retatrutide. That practice defies a longstanding norm in medicine – to wait for the FDA to approve a drug before prescribing it – and is contributing to a booming commercial marketplace for a drug that is barred from sale by federal law.” * * *
    • “It’s on the states to really police this kind of conduct,” said Nathan Cortez, a professor at SMU Dedman School of Law, adding that they often lack enforcement resources. “At some point it becomes so blatant and widespread that, you’re wondering, ‘What are we doing here? Are we going to enforce the law or not?'”
  • The Wall Street Journal adds,
    • Eli Lilly LLY shares rose in early European trade after a late-stage trial showed its drug was effective in weight loss and in alleviating obesity-linked conditions.
    • “Shares jumped 4.4% premarket to $1,181, extending a record high hit at Friday’s market close. The stock is up over 30% since the Indiana-based company reported first-quarter earnings on April 30.
    • “Participants in a Phase 3 trial of retatrutide—an experimental drug targeting obesity-related hormones—showed substantial weight loss, with those taking 12 mg doses losing an average of around 70 pounds over an 80-week period, the company said.
    • ‘One-third of participants on 12 mg doses saw their weight fall into a healthy weight range, while two-thirds fell below the threshold for obesity, Eli Lilly said.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Massachusetts June 8 vacated the $100,000 fee for new H-1B visas established by a proclamation in September 2025. Judge Leo T. Sorkin declared the fees unlawful and said in his decision that it “exceeds the fee-setting authority delegated by Congress.” The AHA last year asked the administration to make healthcare personnel exempt from the fees. The federal government is likely to appeal the June 8 decision.”

Reports from the American Diabetes Association’s annual meeting,

  • Fierce Pharma adds,
    • “With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications. 
    • “Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
    • “Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.” 
  • STAT News notes,
    • “AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market.
    • “In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the American Diabetes Association and published in the Lancet. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)”
    • “In a separate Phase 2 trial in people with diabetes, called SOLSTICE, patients on the highest dose saw up to a 1.74 percentage-point decrease in a measure of blood sugar called A1C after 26 weeks. The study, also published in the Lancet, enrolled people taking oral Ozempic open-label as a comparator group, and they experienced a smaller A1C decrease of 1.32 percentage points.”
  • The American Journal of Managed Care relates,
    • “A trio of studies presented at the American Diabetes Association 2026 Scientific Sessions has reframed the conversation of diet during pregnancy, pointing to diet quality, not just quantity, as a meaningful lever for managing gestational glycemia and postpartum metabolic risk. This is a conversation that has long been viewed through the narrow lens of weight gain and fetal growth.
    • “Across hundreds of pregnancies, researchers of 3 oral presentations found that higher intake of fiber, nonstarchy vegetables, and plant protein were independently associated with lower continuous glucose monitor (CGM) readings,1 while lower-carbohydrate diets in women with gestational diabetes improved glycemic control but raised micronutrient concerns.2 Perhaps most strikingly, women randomly assigned to a higher-complex carbohydrate diet during pregnancy still showed measurably lower postpartum glucose responses 2 months after delivery, suggesting that what a pregnant woman eats may matter long after the birth.3
    • “Together, these findings challenge prevailing assumptions about optimal gestational nutrition and open new questions about how prenatal dietary interventions might be designed to protect both mother and child over the long term.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Tango Therapeutics said Monday its experimental drug vopimetostat showed promise in a small trial in pancreatic cancer, with nearly all of the enrollees followed so far responding to a regimen that combined its medicine with Revolution Medicines’ closely watched treatment daraxonrasib.
    • “The data suggest vopimetostat outperformed daraxonrasib alone in a similar population of people whose disease had progressed after at least one treatment line and exceeded Wall Street expectations. The company plans to initiate a Phase 3 trial later this year testing the combination.” 
  • The American Medical Association lets us know what doctors wish their patient knew about diverticulitis.
    • “Diverticulitis can turn silent colon pouches into painful inflammation. But plenty of interventions are available, depending on severity of diverticulitis.”
  • Per a National Institutes of Health news release,
    • “By inducing specific patterns of activity in small portions of the brain in awake mice, researchers supported by the National Institutes of Health (NIH) have triggered a recalibration of neural connections that normally only occurs during sleep. This new approach offset the effects of sleep deprivation in memory tasks and revealed features of sleep that are key to its restorative effect.
    • “What we’re essentially doing is forcing sleep in a local region of the brain. While that part is solidifying memories and restoring learning capacity, other parts stay aware/vigilant and connected to environment,” said corresponding author Chiara Cirelli, M.D., Ph.D., a professor of psychiatry at the University of Wisconsin-Madison. “Dolphins do something similar, sleeping with only one brain hemisphere at a time.”
    • “Non-rapid eye movement (NREM) sleep, which makes up about 80% of sleep for adults, is when the junctions between neurons that make memories are evaluated. During this phase, the brain protects important connections for long-term storage, prunes those that are less necessary, and makes space for new ones.”
  • Genetic Engineering and Biotechnology News relates,
    • “A study tracking thousands of B cells across more than 100 germinal centers (GCs) in mice has revealed how the system consistently produces highly effective antibodies. The findings overturn longstanding ideas about how germinal centers function, revealing that they are far more selective than once thought, and challenge the idea that antibody improvement is driven mainly by rare growth “bursts” among the most successful B cells. The discovery could have implications for immune cell evolution, and ultimately guide the design of vaccines against rapidly mutating pathogens like influenza. It could also lead to new ways of studying evolution itself.
    • “The traditional, mechanistic view of germinal centers is to think of them as selection machines sorting out the best antibodies,” said research lead Gabriel D. Victora, PhD, head of the Laboratory of Lymphocyte Dynamics at The Rockefeller University. “But when you look very, very closely, you see a process that’s almost essentially random—a little bit better than a coin toss—which repeats many times until the immune system arrives at the right answer consistently. That’s much more akin to how evolution operates than the way a machine does.”
    • “Victora and colleagues reported on their findings in Cell, in a paper titled “Replaying germinal center evolution on a quantified affinity landscape.”
  • Medscape points out,
    • “Metabolic-bariatric surgery (MBS) in patients aged 65 years or older resulted in long-term meaningful weight loss and remission of obesity-related conditions, although complication rates of about 8% were noted.”
  • The Cancer Therapy Advisor notes,
    • “Hyperthyroidism may be associated with an increased risk of breast cancer, particularly premenopausal breast cancer, according to research published in Cancer Epidemiology, Biomarkers & Prevention.
    • “Findings from in vitro studies have indicated that thyroid hormones can have estrogen-like effects. That suggests that thyroid hormones may affect cellular proliferation of breast tissue and subsequently increase breast cancer risk in people with hyperthyroidism, researchers explained. In this study, the researchers assessed the effects of hyperthyroidism and hypothyroidism on incident breast cancer in women from the Sister Study.
    • “Women diagnosed with hyperthyroidism or receiving related treatment may have elevated BC [breast cancer] risk, particularly premenopausal BC,” the researchers concluded. “Although more research is needed, premenopausal women treated for hyperthyroidism may benefit from enhanced breast cancer screening.”

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

  • Fierce Healthcare reports,
    • “Medicare Advantage insurer Essence Healthcare is continuing to build out its partnership with Oura and has unveiled a new clinical program that aims to identify potential sleep apnea risk.
    • “Essence is rolling out a new clinical workflow that will arm physicians with insights into patients’ nighttime breathing habits to identify those who may be at risk for obstructive sleep apnea. The insurer offers the ring as a covered benefit through some of its plans and has been working with Oura’s team to identify more clinical applications for its data.
    • “News of the partnership expansion was shared first with Fierce Healthcare.
    • “Through the program, insights into members’ sleep, as identified by the Oura Ring, will be shared with Essence with the patients’ consent. The insurer then uses Lumeris’ Tom platform to reach out to at-risk individuals and guide them through STOP-BANG, a common evidence-based screening for sleep apnea.”
  • and
    • “Artificial intelligence is here to stay in healthcare, and the industry’s largest players, like CVS Health, are making huge commitments to the tech.
    • “But embracing AI requires a workforce that’s ready for the revolution. With that backdrop, CVS has rolled out its internal AI Learning Academy, which aims to educate its workforce on practical applications for the technology and how it can impact and improve their workflows.
    • “The program was built in collaboration between human resources and tech leaders at the company. Greg Karanastasis, senior vice president for talent and development at CVS, told Fierce Healthcare that the aim was to build something bigger than just a training program.”
  • Per an Institute for Clinical and Economic Research (ICER) news release,
  • MedCity News tells us about “The 3 Biggest Roadblocks to Egg Freezing — and How Providers Are Working to Remove Them.”
    • “Egg freezing has gained popularity as a fertility preservation tool, but experts say high costs, uncertain outcomes and timing challenges continue to deter many women from pursuing it.”
  • MedTech Dive informs us,
    • “Boston Scientific is investing approximately $138 million to build a 500,000-square-foot distribution facility in Plainfield, Indiana.
    • “Indiana Gov. Mike Braun, who announced the project last week, said Boston Scientific will break ground on the facility this year and ultimately create up to 300 jobs. 
    • “Boston Scientific is building the facility to complement its existing distribution network, which includes sites in Georgia, Massachusetts and Minnesota.”
  • BioPharma Dive notes,
    • “Incyte, a drugmaker with a heavy focus on blood diseases and cancers, plans to take control of an experimental medicine that could help control bleeding in a variety of disorders.
    • “Vega Therapeutics, a subsidiary of the “hub-and-spoke” biotech Star Therapeutics, has been developing this “VGA039” medicine primarily as a treatment for von Willebrand disease — the most common inherited bleeding disorder. Now, Incyte has agreed to buy Vega for $1.25 billion up front. Star would be eligible to receive as much as $750 million more if certain sales goals are eventually met.
    • “Patients with von Willebrand disease lack an important clotting protein, meaning that, when they suffer any kind of injury, the bleeding usually takes longer to stop. In severe cases, this bleeding can cause joint or organ damage and be life-threatening. Current preventative treatments include so-called factor replacement therapies given as intravenous infusions two to three times a week. VGA039, meanwhile, comes as a once-monthly, under-the-skin injection that patients can do themselves.”
  • The Wall Street Journal relates,
    • “Roche Holding struck a deal with Nurix Therapeutics NRIX to license an experimental blood-cancer drug for up to $2.3 billion, expanding its pipeline in oncology and potentially other therapeutic areas.
    • The Swiss drugmaker on Monday said it would make an upfront cash payment to Nurix of $700 million, with additional payments subject to the drug, bexobrutideg, reaching development, regulatory and sales targets.
    • Bexobrutideg is due to enter late-stage studies for the treatment of chronic lymphocytic leukemia this summer, Roche said.
    • “The main opportunity for us is in B-cell malignancies. There are many B-cell malignancies and the most dominant of interest for us is chronic lymphocytic leukemia,” Roche’s deputy chief medical officer, Stefan Frings, said in an interview.
    • “The company said the medicine has potential to offer higher efficacy and more favorable tolerability than established therapies for leukemia. The drug is a so-called BTK degrader designed to remove the BTK enzyme from cells, rather than blocking its effects, and overcome resistance.”
  • and
    • “Johnson & Johnson JNJ  has agreed to buy biotechnology company Firefly Bio for $1 billion in cash in a deal that bolsters the drugmaker’s oncology pipeline.
    • “J&J on Monday said Firefly is developing its proprietary Firelink degrader antibody conjugate platform, for KRAS-driven cancers, which have limited treatment options with survival measured in months.
    • “Mutations of the KRAS gene have long been considered undruggable because the gene’s structure lacks the deep binding pockets most drugs need.
    • ‘J&J said the Firelink platform is a novel approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.”
  • and
    • “Novo Nordisk NOVO.B said prescriptions for its Wegovy weight-loss pill have surpassed three million since launching in early January.
    • “The Danish drugmaker said late Sunday that the pill hit one million prescriptions 12 weeks after reaching U.S. pharmacies and online providers, with a further two million prescriptions achieved in the following 10 weeks.
    • “More than 80% of new prescriptions filled for the Wegovy pill are for patients new to the GLP-1 class of drugs, which the company says indicates that the new oral formulation is expanding the obesity treatment market, rather than replacing existing injectable therapies.”
  • Fierce Pharma adds,
    • “On a weekly basis, total GLP-1 prescriptions were trending downward over the week of June 1, falling 5.7% week-over-week, Citi analysts noted. Other than the continued rollout of Lilly and Novo’s respective weight loss pills, the analysts cited the effect of the Trump administration’s “most favored nation” pricing policies as a key future event that they think could impact total prescriptions.” 

Noteworthy Death

  • AP reports
    • “Harvard University professor Robert Coles, the psychiatrist and Pulitzer Prize-winning author who championed the cause of children grappling with poverty and segregation, has died at 97, his son said Sunday.
    • “The son, also named Robert Coles, told The Associated Press that his father died Thursday at a hospice center in Lincoln, Massachusetts.
    • “The elder Coles was famed for documenting the needs of children, particularly those caught in the crucible of social upheaval. The second and third parts of his five-volume “Children of Crisis” won him a Pulitzer Prize in 1973 for general nonfiction.
    • “In a 1965 Washington Post essay, he wrote that, expecting to find many psychiatric problems among the children of poverty, that instead “I was constantly surprised at the endurance shown by children we would all call poor or, in the current fashion, ‘culturally disadvantaged.’”
  • RIP

Thursday report

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medicare, NIH, OPM, SCOTUS, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • The Wall Street Journal reports,
    • “Republican senators stopped short of using their political leverage to kill President Trump’s $1.8 billion “anti-weaponization” fund, approving a critical immigration-enforcement bill without adding language reining in the controversial program.
    • “Passage of the $70 billion package funding Immigration and Customs Enforcement and Border Patrol through the end of Trump’s second term came after a more than 19-hour session of amendment votes and intraparty negotiations. The GOP-backed measure passed 52 to 47 shortly before 5 a.m., with Republican Sen. Lisa Murkowski of Alaska voting with Democrats against the bill.
    • “The session’s votes allowed GOP senators in competitive election fights this fall—including Susan Collins of Maine, Dan Sullivan of Alaska, Jon Husted of Ohio and Ashley Moody of Florida—to register their objections to the fund without derailing a bill that is a priority for Trump and the party.
    • “The House is expected to take up the immigration-enforcement measure next week.”
  • The No Surprises Act’s final independent dispute resolution (IDR) rule was published in the Federal Register today. Federal Hearings and Appeals Services, which a certified IDR entity, offers its summary of the rule with helpful charts!
  • Federal News Network reports
    • The Postal Service, on the verge of running out of cash early next year, is pricing out a wide range of possible reforms that, if passed by Congress, could address the agency’s long-term financial problems.
    • Postmaster General David Steiner told House lawmakers in March that USPS is set to run out of cash in early 2027 and that lawmakers need to act soon to keep the agency running.
    • The agency’s wish-list of possible legislative reforms, outlined in a document titled “Accelerating Progress: Elements of Postal Reform,” includes several longstanding proposals supported by postal watchdogs and unions. The document also considers more controversial options, such as closing post offices and reducing delivery days to save USPS billions of dollars each year.
  • Per a House of Representatives Oversight and Government Reform news release,
    • “Subcommittee on Government Operations Chairman Pete Sessions (R-Texas) delivered his opening statement at today’s hearing with the Commissioners of the Postal Regulatory Commission. In his opening remarks, Subcommittee Chairman Sessions highlighted the financial crisis the U.S. Postal Service (USPS) is facing and how actions to reform the agency have fallen short of expectations. He also emphasized that Congress and the American people have to decide what they want out of USPS to help resolve procedural and financial issues in the agency.” 
  • The OPM Director Scott Kupor added to his Secrets of OPM blog (available on LinkedIn and Substack) concerning a Presidential Memorandum approving the use of critical position pay to support investment programs related to national security.
  • Tammy Flangan, writing in Govexec, discusses whether a record number of new retirees this year will slow your retirement claim.
    • “New OPM data offers clues about processing times, potential delays and why retiring employees may need a larger financial cushion than expected.” 
  • Per a National Institutes of Health news release,
    • “National Institutes of Health Director Jay Bhattacharya, M.D., today announced the selection of Steven Schiff, M.D., Ph.D., as the next director of the Fogarty International Center (FIC) and NIH associate director for international research. Schiff began his role on June 4, 2026. 
    • “A pediatric neurosurgeon and global health researcher, Schiff currently serves as the Harvey and Kate Cushing Professor of Neurosurgery, vice chair for global health in the Department of Neurosurgery, and professor of epidemiology and of electrical and computer engineering at Yale University in New Haven, Connecticut.” * * *
    • “As director of FIC, Schiff will lead NIH’s global health research efforts by supporting collaborations between U.S. and international investigators, strengthening partnerships among research institutions worldwide, and training future global health scientists. He will oversee the center’s approximately $95 million annual budget, most of which supports research grants and training programs.” 
  • Beckers Health IT lets us know,
    • “The White House is backing a push for AI to take over more of the duties of physicians, The Washington Post reported.
    • “The Trump administration supports an experiment in Utah where AI is writing prescriptions, plans to offer over $50 million in research awards to developers of conversational AI for cardiovascular care, has created an expedited approval process for digital health products like AI chatbots, and is working on a regulatory pathway for independent AI physicians, according to the June 4 story.
    • “People are seeing the difference the AI is bringing,” Amy Gleason, the administrator of the Department of Government Efficiency who is now a healthcare AI advisor at HHS, told the news outlet. “And it’s like the genie is out of the bottle.”
  • and
    • “HHS, under Secretary Robert F. Kennedy Jr., has sought access to detailed patient records held by state health information exchange systems as part of an effort to research a potential link between vaccines and autism, KFF Health News reported June 4.
    • “Federal officials met with leaders of state-run health information exchanges several times over the past year, asking how the medical records they maintain from hospitals and health systems could be used for vaccine research, according to seven people familiar with the meetings.”

From the Food and Drug Administration front,

  • STAT News reports,
    • “Leaders at the Food and Drug Administration on Thursday listened to criticisms and recommendations for how to move forward with a speedy drug review program put in place by former FDA commissioner Marty Makary. 
    • “The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, and academic organizations. Some had positive feedback, particularly those whose drugs have already been approved through the program. But most asked the agency to pause the program, and then bring it back through normal regulatory procedures that require public feedback.” 
  • Per a corporate news release,
    • “Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).”
  • Reuters relates,
    • “The U.S. FDA’s Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for ​an artificial intelligence-based drug development tool designed to ‌help predict drug-induced liver injury.
    • ‘Drug-induced liver damage is a major cause of trial failures, and current methods do not reliably ​predict human risk. The U.S. Food and Drug Administration said ​the tool could potentially help improve early safety assessments, reduce reliance ⁠on animal testing and support more informed decisions before human trials ​begin.’

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over a competitor’s generic versions of their drugs that are marketed using what’s called a skinny label.
    • “The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.’s infringement suit over claims that Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.
    • “Drugmakers frequently obtain patents not just on chemical compounds they discover for novel drugs, but separately for methods of using such drugs to treat various medical conditions. When some uses are covered by active patents while others aren’t, generics can get government approval of a “skinny label” that carves out the patented uses.
    • “Thursday’s ruling ramps up the evidence that branded drugmakers need in order to sue when they think the generic label in combination with a generic company’s marketing statements or other communications cross a line into actively inducing patent infringement.”

From the public health and medical / Rx research front,

  • The New York Times reports,
    • “Scientists have made a discovery that may help prevent some people from developing lung cancer, which kills more people worldwide than any other cancer. 
    • “A team of more than 80 researchers working across four continents have identified a set of proteins in the blood that accurately predict lung cancers more than five years before diagnosis. The scientists also found early evidence that an existing anti-inflammatory drug could significantly reduce lung cancer risk in people with elevated concentrations of these proteins, which they linked to inflammation.
    • “More research is needed before a test based on these proteins could be ready for use in patients. And scientists would still need to run a randomized trial to determine whether the drug prevents lung cancers. Still, outside experts said the findings, which were published on Thursday in the journal Cell, offer a promising starting point toward a long-held public health goal.”
  • The Washington Post adds,
    • “The story of GLP-1 drugs keeps getting bigger.
    • “First they transformed the treatment of diabetes. Then they upended the science — and culture — of weight loss. Now a growing body of research is raising another possibility: that these drugs may help protect against cancer.
    • “At this year’s American Society of Clinical Oncology (ASCO) meeting in Chicago, more than 40 studies, abstracts, oral presentations and poster presentations examined the relationship between GLP-1-based drugs and cancer. The results were strikingly consistent. Taken together, they suggest that people taking medications such as Ozempic, Wegovy and Mounjaro may develop certain cancers at lower rates than comparable patients who are not taking the drugs — and that those already diagnosed may experience a slower decline and better outcomes.
    • “For oncologists, the accumulation of evidence is hard to dismiss. The findings are “super promising,” said Mark Orland, a cancer researcher at the Cleveland Clinic. “We’re really excited to be on the forefront of looking at the effects of these drugs.”
  • Health Day relates,
    • “A simple urine test might help identify children who are likely to have autism earlier than the best assessment tools now available, a new study says.
    • “Autistic children appear to have specific gut microbe profiles that can be used to distinguish them from neurotypical (or typically developing) children, researchers reported May 26 in the journal Molecular Psychiatry.
    • “A urine test based on these profiles correctly identified 90% of autistic children and did not misidentify any children without autism, researchers found.
    • “What’s really striking about the bacteria is that they make metabolites that are basically altered versions of serotonin and dopamine,” said researcher James Adams, a professor of engineering at the Biodesign Center for Health Through Microbiomes at Arizona State University (ASU) in Tempe.”
  • and
    • “Mailed fecal immunochemical tests (FITs) can significantly increase colorectal cancer (CRC) screening across racial and ethnic groups, according to a study published in the May/June issue of the Annals of Family Medicine.
    • “Anisha P. Ganguly, M.D., from the University of North Carolina at Chapel Hill, and colleagues compared the effects of a CRC intervention (mailed FIT for screening-eligible patients plus patient navigation for positive results) across race/ethnicity. The analysis included 3,734 patients at federally qualified health centers.” * * *
    • “This analysis showed that mailed colorectal cancer screening tests have the power to improve screening rates for diverse populations,” Ganguly said in a statement. “This is really important, because we want these innovations in screening to improve outcomes among the hardest to reach populations and move the needle on colorectal cancer disparities.”
  • The American Journal of Managed Care tells us,
    • “Sudden death has long been considered an abrupt and unpredictable event in patients with heart failure
       (HF). But a new post hoc analysis of the FINEARTS-HF randomized clinical trial challenges that assumption, finding that most sudden deaths in patients with HF with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) are preceded by measurable clinical deterioration in the months before death.”
  • According to Infectious Diseases Advisor,
    • “Maternal SARS-CoV-2 mRNA vaccination during the third trimester reduces risk for infection and related hospitalization in infants through 6 months of age, highlighting the importance of maternal vaccine timing.”
  • STAT News informs us,
    • “Otsuka’s Voyxact slowed the loss of kidney function after one year in patients with a chronic autoimmune kidney disease, but the benefit was less than expected and left room for competing treatments to perform better. 
    • “In a Phase 3 study, patients with IgA nephropathy, or IgAN, who received injections of Voyxact saw their kidneys lose function at an annualized rate of 3 points over one year compared to an annualized function loss of 7.6 points over one year for patients receiving a placebo, the Japanese drugmaker reported Thursday.” * * *
    • “While the relative improvement in kidney function was positive, the result was also less robust than what was seen in an earlier Otsuka study. The data left open the possibility that competing drugs from Vera Therapeutics and Vertex Pharmaceuticals may be able to show a larger effect on kidney function when their respective studies read out results.” 

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

  • Beckers Payers Issues reports,
    • “UnitedHealth Group and CVS Health, Aetna’s parent company, are among the top 10 companies on the Fortune 500 this year.
    • “Fortune‘s June 3 list ranks the top 500 U.S. companies by revenue. Nine health payers [which are listed in the article] made the cut, with 2025 revenues ranging from $11.7 billion to $447.6 billion.
    • “UnitedHealth Group held its third-place standing from 2025. Amazon topped the list, ending Walmart’s 13-year tenure in the top spot.”
  • Beckers Hospital Review relates,
    • “Brentwood, Tenn.-based Lifepoint Health has completed its acquisition of eight community hospitals from Louisville, Ky.-based ScionHealth.
    • “The hospitals are spread across six states, according to a June 2 news release. Lifepoint acquired:
      • “Bolivar Medical Center in Cleveland, Miss.
      • “Ennis (Texas) Regional Medical Center
      • “Livingston (Tenn.) Regional Hospital
      • “Logan (W.Va.) Regional Medical Center
      • “Palestine (Texas) Regional Medical Center
      • “Parkview Regional Hospital in Mexia, Texas
      • “St. Joseph Regional Medical Center in Lewiston, Idaho
      • “Watertown (Wis.) Regional Medical Center
    • “Lifepoint originally signed an agreement to acquire the hospitals in March.
    • “ScionHealth said the eight hospitals will keep their current employees, providers and services. The company described the divestiture as part of a broader effort to strengthen its capital structure and focus on core operations.”
  • Healthcare Dive adds,
    • “West Virginia University Health System has solidified the next phase in its plan to acquire Greensburg, Pennsylvania-based nonprofit Independence Health System, announcing this week the two parties had signed a definitive agreement to combine.
    • “As part of the deal, which was announced last year, WVU Health System will invest $800 million into Independence’s five hospitals in order to install a new electronic health record and upgrade the facilities.
    • “The health systems now expect the acquisition will close in September or October, pending regulatory approval.”
  • Fierce Healthcare tells us,
    • “Due to advances in cancer treatment and early detection, the population of cancer survivors continues to grow, reaching more than 18 million individuals in the U.S. By 2035, that number is projected to exceed 22 million.
    • “But many cancer survivors have ongoing medical and mental health needs after cancer treatment ends. Faced with long-term side effects, behavioral health challenges and hormone therapies, many survivors are left to manage these healthcare challenges on their own.
    • “Value-based cancer care navigation company Thyme Care has expanded its cancer survivorship program, called Next Chapter Care, to provide a personalized, longitudinal approach to survivorship support. That program provides coordinated oncology support beyond active treatment for the more than 15,000 Thyme Care members who have completed cancer treatment.
    • “Rather than treating survivorship as a disconnected phase of care, the program extends the existing relationship Thyme Care already has with members across diagnosis, treatment and recovery, according to the company.”
  • and
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. 
    • “Artificial intelligence-powered payer intelligence startup Anomaly Insights launched a new tool aimed at providing managed care executives with evidence to bring to payer negotiations. 
    • “Anomaly Insights seeks to take on what Anomaly CEO Mike Desjadon told Fierce Healthcare is an “adversarial payment system” in the U.S. healthcare industry. He added there is also a “fundamental asymmetry” in data between insurance companies and health systems. 
    • “It’s that asymmetry that allows an insurance company to basically make the health care system chase its tail with denials and all the things that they do with data,” Desjadon said. “
  • Beckers Hospital Review points out,
    • “Active drug shortages in the U.S. rose for the second consecutive quarter in 2026, reaching 223 in the first quarter, according to the American Society of Health-System Pharmacists — and the FDA’s database continues to reflect new discontinuations weekly. The database is updated daily to reflect manufacturing recoveries, regulatory actions and how shortages are classified — not solely day-to-day availability at the hospital level.”
    • The article also lists eight recent additions to the shortage list.

Tuesday Report

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

Simplicity is a virtue

“Edsger Dijkstra put it best: “Simplicity is a great virtue, but it requires hard work to achieve it and education to appreciate it. And to make matters worse, complexity sells better.” This bias for complexity leads us to give undue credit to convoluted systems and ideas over simple, elegant solutions.”

From Washington DC,

  • CMS reminds us that “June 1 marked the start of Medicare Fraud Prevention Week. While this week shines a spotlight on fraud prevention, protecting Medicare is a year-round mission.” 
  • In that regard, the Wall Street Journal points out that “The Autism-Therapy Business Is Booming—and So Is the Billing Abuse. Insurers warn of fraud and exorbitant charges from providers, including one that stuck a parent with a surprise $911,400 bill.”
  • AHIP posted a news release about how healthplans are combatting fraud, waste, and abuse in Medicaid. In fact, health plans are combatting fraud, waste, and abuse whereever they offer coverage.
  • Last Wednesday, the OPM Inspector General posted his semi-annual report to Congress for the period ended March 31, 2026.
  • OPM posted a news release today on its Family Member Eligibility Documentation rule, which OPM described as “a major step in the administration’s broader effort to eliminate fraud, waste, and abuse across government programs.” As the FEHBlog noted yesterday, this final rule was published in the Federal Register today.
  • The American Hospital Association News reports,
    • “The AHA June 2 released a new report, “Making Health Care More Affordable: A Blueprint to Lower Costs, Improve Access and Enhance Quality.” 
    • “The report contains actionable and achievable strategies and solutions that are focused on improving the health of individuals and communities; transforming care delivery; reducing administrative waste in the system; lowering drug and device costs; and innovating to improve care outcomes. 
    • “The report, as well as an infographic that highlights several action items from the report, was produced with input gathered throughout the year from AHA members across the country.”
  • Healthcare Dive relates,
    • “Eli Lilly is giving hospitals and medical groups in the 340B drug discount program less than a week to comply with the drugmaker’s data sharing requirements or be cut off from valuable savings on Lilly’s medications.
    • “In January, Lilly said it would begin requiring providers to submit claims data for all of its drugs dispensed in 340B. The company hasn’t been enforcing the policy. But now, providers that don’t comply with Lilly’s ultimatum by this coming Monday will lose access to 340B discounts on the drugmaker’s medications, Lilly warned this week.
    • “Lilly argued it needs to collect more data from providers to ensure they aren’t double-dipping discounts in 340B with savings in other programs like Medicaid. However, hospitals argue the move is illegal and, if not stopped by regulators, will empower other pharmaceutical companies to take similar actions.”
  • Adam Fein, writing in his Drug Channels blog, offers his take on the curent state of the 340B drug discount program.

From the Food and Drug Administration front,

  • Per an FDA news release,
    • “The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge.
    • “When finalized, the guidance will outline how sponsors can use publicly available information and established platform knowledge, including chemistry, manufacturing and controls (CMC) data, nonclinical study results and clinical information, to streamline regulatory submissions for human gene therapy products that use genome editing in human somatic cells.”
  • Reuters reports,
    • “Drug developer Cingulate (CING.O) said on ​Tuesday the U.S. Food and Drug Administration declined to approve its ‌treatment for attention deficit hyperactivity disorder, citing manufacturing-related concerns.
    • “In its complete response letter, the FDA did not flag any concerns about the drug’s safety or effectiveness, Cingulate said.”

From the judicial front,

  • Fierce Healthcare reports,
    • “Ascension’s $3.9 billion plan to acquire ambulatory surgery management services company AmSurg has received a green light from the Federal Trade Commission, so long as the nonprofit health system divests a handful of facilities in markets the regulator said would otherwise be left with reduced competition. 
    • “The proposed consent order between the FTC and Ascension was announced Tuesday and centers on seven AmSurg ambulatory surgery centers (ASCs) in Panama City, Florida; Tulsa, Oklahoma; Waco, Texas; Wichita, Kansas; and Nashville, where two sites are located. 
    • “The handoffs must be completed by the time of the acquisition’s close, per the proposed consent order. Six of the facilities are earmarked to join SC Affiliates, another national ASC operator, with the seventh center in Panama City going to Florida Gastroenterology Center, a physician group and current minority owner.” 

From the public health and medical / Rx research front,

  • Health Day reports,
    • “The number of people suffering with long COVID could be double current estimates, a new study suggests.
    • “An AI tool found that about 16% of nearly 460,000 patients with COVID-19 had developed long COVID, researchers reported May 27 in JAMA Network Open.
    • “Applied across the United States, those rates translate to more than 18 million Americans with long COVID, which is twice as high as current estimates, researchers said.
    • “Over 10 million people with long COVID would go entirely undetected by the diagnostic code that health systems and policymakers rely on to track the disease burden,” said senior researcher Hossein Estiri, an associate professor in the Mass General Brigham Department of Medicine in Boston.
    • “And it’s likely the picture is even worse than these estimates, researchers said.
    • “The figures we uncovered are almost certainly an undercount,” Estiri said in a news release.”
  • and
    • “Folks who regularly exercise can lower their risk of heart attack and heart failure linked to a genetic heart condition, a new study says.
    • “People with higher levels of moderate to vigorous physical activity had lower rates of heart health problems caused by genetically driven cardiomyopathy, researchers reported recently in the American Journal of Preventive Cardiology.
    • “Cardiomyopathy is a group of diseases that weaken the heart muscle, causing it to inefficiently pump blood to the rest of the body, researchers said in background notes.
    • “Our findings suggest that, even among people who carry genetic variants for cardiomyopathy but have no signs of disease, staying physically active may be associated with lower rates of future cardiovascular events,” said senior researcher Dr. Pankaj Arora, director of the University of Alabama at Birmingham’s (UAB) Cardiogenomics Clinic Program.
    • “Genetic risk may not be deterministic, and exercise is a modifiable factor that people can act on to help protect their heart,” he said in a news release.”
  • MedPage Today adds,
    • “Losing visceral fat by diet and exercise — regardless of pounds shed or later regained — was tied to long-term improvements in cardiometabolic health, follow-up data from two randomized trials showed. (Circulation)”
  • Gatroenterology Advisor notes,
    • “Higher levels of objectively measured physical activity are associated with significantly lower odds of irritable bowel syndrome (IBS), while greater sedentary behavior is associated with increased IBS prevalence, according to study findings published in the American Journal of Gastroenterology.”
  • The National Institutes of Health’s Research Matters post covers the following topics in today’s release:
    • “Tuberculosis test may improve diagnosis 
      • “Researchers found that a new portable diagnostic test for tuberculosis produced rapid and accurate results.
      • “The new test could offer a low-cost way to more quickly diagnose and treat people across the world.”
    • “Blood test predicts tumor response to treatment”
      • “Researchers identified distinct cellular neighborhoods common to different tumors, some of which correlate with treatment response.
      • “A blood test to analyze these neighborhoods could lead to more effective personalized cancer therapies and improve treatment monitoring and outcomes.”
    • “Short RNAs may prevent neuron death linked to ALS, dementia
      • “In cell and animal models, short RNA molecules stopped or reversed abnormal clumping of the TDP-43 protein, which is linked to brain cell death.
      • “The results suggest RNA-based therapies could one day be used to treat diseases marked by abnormal TDP-43, including ALS and Alzheimer’s disease.”
  • NBC News relates,
    • “Nearly 1 in 5 adolescents and young adults are turning to AI chatbots for advice when they’re sad, angry, nervous or stressed, according to a new study.
    • The findings, from the research institute RAND, represent an increase from early 2025, when the nonprofit conducted a similar survey. At the time, around 13% of respondents said they used chatbots for such advice, but the share rose to 19% in the group’s latest survey in November, the results of which were published Monday in the journal JAMA Pediatrics. 
    • “It’s a sad number, because you’d hope that young people would have the sorts of supportive relationships that they would feel comfortable and empowered reaching out to those around them,” said Ryan McBain, a senior policy researcher at RAND and the lead author of the study.”
  • Fierce Pharma informs us,
    • “A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug’s ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC). 
    • “In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial’s primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday. 
    • “The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.”

Wrapping up the American Society of Clinical Oncologists annual meeting,

  • STAT News reports,
    • “The ASCO meeting is about data — lots and lots of data. But above all it is about, or should be about, patients.
    • To that, ASCO’s outgoing president, Eric Small, used his opening address at the meeting to speak about his partner, University of California, San Francisco, oncologist Amy Lin, who passed away in December. She had metastatic clear cell ovarian cancer, a rare disease with few treatment options. Small also brought a different kind of specialist to ASCO’s mainstage: David Kessler, an expert on grief and loss, who gave a talk about compassionate end-of-life care.
    • “I remember the exact moment when I said, ‘You know, someone should do something about this.’ And it dawned on me that I could. I was fortunate enough to have this platform, and could use it to at least raise it as an issue. I don’t know what the solution is, but I do know that if more of us are aware of it, and can talk about it, my hope is that it would have an impact in a room full of oncologists.”
    • :The experience, Small told STAT, made him realize that while he always tells families how profoundly sorry he is for their loss, he was “really just sending them off on a grief journey that is really complicated and really hard.”
    • “And he wanted to do something about it.
    • “Read a Q&A with Small here.”
  • NBC News relates,
    • “An experimental vaccine from Moderna and Merck shows promise in keeping deadly skin cancer from returning for years, according to new clinical trial results. 
    • “The research, presented Monday at the American Society of Clinical Oncology’s annual meeting, found that a personalized mRNA vaccine halved the risk of melanoma returning after five years. The results were also published in the Journal of Clinical Oncology.
    • “Melanoma is the deadliest form of skin cancer, and in about half of patients, the disease will come back within the first five years of treatment.
    • “The treatments we have are not perfect. People relapse,” said Dr. Janice Mehnert, the director of the melanoma and cutaneous medical oncology program at NYU Langone Health in New York and the senior trial investigator.”
  • BioPharma Dive tells us,
    • “Two drug regimens involving an experimental medicine from Celcuity halved the risk of death or disease progression in a late-stage trial in certain people with a type of advanced breast cancer. But the results still fell short of Wall Street expectations, sending the company’s shares plummeting by more than 20%.
    • “Celcuity disclosed last month that its therapy, gedatolisib, succeeded in the latest part of a Phase 3 study evaluating the treatment in breast cancer patients with or without mutations to a gene called PIK3CA. Fresh data presented Tuesday at the American Society of Clinical Oncology’s annual meeting revealed the extent to which patients with those mutations benefited from treatment with Celcuity’s therapy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “NYU Langone Health is constructing a multibillion-dollar academic medical center and hospital on Long Island. 
    • “The new hospital in Melville will include 500 private inpatient rooms, 70 emergency department bays and the latest diagnostic imaging capabilities, the healthcare system said in a statement on Tuesday. The campus will also have space for scientific research and comprehensive outpatient care.” * * *
    • “While the project is still subject to state and local approvals, it’s estimated to create as many as 8,000 union construction jobs with an additional 2,500 jobs across the region. 
    • “The facility will be the first hospital built on Long Island since 1980, where some communities face long travel times for specialized care. A spokesperson for NYU said the system doesn’t have a final cost estimate for the project but it spent $135.5 million to purchase the land.” 
  • Healthcare Dive relates,
    • “Community Health Systems closed the sale of four hospitals in Arkansas to Missouri-based Freeman Health System for $110 million, the for-profit health system said Monday. 
    • ‘The deal, first announced in March, marks Freeman’s expansion into Arkansas. The purchase includes hospitals in Bentonville, Springdale, Johnson and Siloam Springs, as well as associated outpatient locations, physician practices and around 2,200 employees, Freeman said Monday.”
  • Meanwhile, Beckers Hospital Review points out
    • “Seven hundred and twenty rural hospitals across the U.S. — representing about one-third of all rural facilities nationwide — are at risk of closing due to severe financial problems, according to the Center for Healthcare Quality and Payment Reform’s most recent analysis. 
    • “The data, current as of May 2026, includes 294 hospitals that are at immediate risk of closure over the next two to three years due to the severity of their financial situation, according to the report. Facilities with the greatest risk of closure have more debt than assets or lack enough financial reserves to offset losses on patient services for more than a few years. 
    • “Rural hospitals are at risk of closing in almost every state, according to the report. In the majority of states, more than 25% of rural hospitals are at risk. In 10 states, 50% or more are at risk. 
    • “The number of hospitals at risk of closure represents a slight decrease from CHQPR’s January analysis, which found 734 hospitals were at risk of closure, including 309 that were at immediate risk. Since that report, three hospitals have closed and eight have converted to rural emergency hospitals. CHQPR does not assess converted rural emergency hospitals for closure risk until cost report data is available under their new designation.”  
  • Kaufman Hall tells us,
    • “Use of health-related apps and devices has increased since 2021, even as consumers become more selective about the technologies they adopt, according to a report published this month. While nearly half of consumers track biometrics, sleep, or activity levels, usage patterns vary by age, and interest in many digital health services has declined post-pandemic. This signals shifting consumer expectations and preferences for digital health technology users increasingly want tools that help them track progress conveniently and accurately while fostering motivation, accountability, and a sense of control over their health, according to the report. Integrating patient-generated data from apps and devices into digitally connected care experiences may help health systems strengthen engagement beyond the hospital walls.”
  • Fierce Healthcare adds,
    • “Wearable ownership has risen 33% in the U.S. since 2015, a new analysis from Rock Health found.
    • “Forty-six percent of respondents in the 2025 Consumer Adoption of Digital Health Survey reported owning a wearable specifically, and 57% of respondents report owning at least one wearable or other connected device. However, the report notes first-time wearable user growth has slowed.
    • “Smart watches remained the most popular device among the survey’s 8,000 respondents, with 43% reporting owning a device. Other popular devices are smart scales (13%), connected blood pressure cuffs (13%), continuous glucose monitors (9%) and smart rings (8%).
    • “The next chapter of wearable adoption will come down to whether wearables remain primarily tools for individualized self-optimization—an “N of 1” model—or evolve into infrastructure that improves population health,” the report authors wrote.”