Monday report

Agentic & Generative AI

Monday report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, No Surprises Act, Obesity, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Wall Street Journal reports,
    • “South Carolina Gov. Henry McMaster named Darline Graham Nordone, the sister of the late Sen. Lindsey Graham of South Carolina, to serve as an interim replacement in the Senate in the aftermath of the longtime lawmaker’s death. 
    • “President Trump had told McMaster, a Republican, that an appointment of Graham Nordone “would be a fabulous tribute to Lindsey, who loved her dearly!” Graham Nordone will serve out the remainder of her late brother’s term, which ends in early January.
    • “McMaster said Graham “took care of his little sister in years long departed. It’s my honor to ask his little sister, Darline Graham, to finish his work for him now.”
    • “Graham Nordone said, “Lindsey has always been there for me, and now I will be there for him.”
  • Fierce Healthcare relates,
    • “Insurers expect to issue $759.2 million in medical loss ratio rebates this year, according to a new analysis.
    • “The report is based on data reported by payers to states and compiled by analytics firm Mark Farrah Associates. An analysis of the data from KFF projects that total rebates paid out since their 2012 launch will rise to $15.1 billion after 2026 payments are made later this year.” * * *
    • “The estimated 2026 rebate tally is the lowest since 2018, when insurers paid $706.7 million in rebates, according to the KFF report. Rebate payments peaked in 2020 at $2.5 billion.” * * *
    • “The average simple loss ratio—which does not account for taxes or quality improvements like the MLR used to calculate rebates—was 93% in 2025, meaning plans spent 93% of their premium income on claims on average.” 
  • Healthcare Dive tells us,
    • “The oversight office of the HHS said it generated about $5.6 billion in monetary impact from fighting fraud, waste and abuse in federal health programs between October and March.
    • “The HHS Office of Inspector General also said it kicked over 1,200 people and entities off federal programs and pursued enforcement actions against people accused of running sham hospices and requesting improper Medicaid payments for autism behavioral therapy services, among others.
    • “The updates, part of a report compiled every six months for Congress, outlined the Trump administration’s healthcare enforcement priorities, adding that the HHS would focus on rooting out fraud in Medicaid and Medicare Advantage.”
  • Gilsbar, an insurance brokerage, offers information about recent revisions to the IRS Form 720 which is used to pay the annual PCORI fee.

From the Food and Drug Administration front,

  • Psychdelic Alpha reports,
    • “This morning, FDA issued its final guidance on psychedelic clinical investigations and announced a September public hearing “on the potential future therapeutic use of psychedelic drugs” and an associated request for comments. (We provided a detailed breakdown of the final guidance, as well as coverage of the planned hearing, in our Pα+ article: FDA Issues Final Psychedelics Guidance, Schedules September Hearing on the Future of Psychedelic Therapies.)
    • “Then, this afternoon, HHS and VA announced that they have entered into a five-year Memorandum of Understanding (MOU) “to strengthen collaboration on the research, clinical development, and responsible deployment to veterans suffering from serious mental health conditions of potential future rapid-acting psychedelic drug products if approved by the Food & Drug Administration.”
  • The Pharmacy Times relates,
    • “The FDA approved a new starting dosage regimen for the subcutaneous formulation of lecanemab-irmb (Leqembi; Eisai, Biogen), marking the first time patients can begin treatment with home administration either by themselves or by their caregiver,
    • “Lecanemab is an amyloid beta-directed antibody that targets and removes beta-amyloid from the brain. There is no evidence that lecanemab restores or reverses lost memories or cognitive function, but it is proven to reduce both cognitive and functional decline in patients, according to the Alzheimer’s Association.” 
  • Fierce Pharma tells us,
    • “In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA.
    • “Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
    • ‘Without going into specifics, GSK said its PD-1 inhibitor showed a “substantial improvement” compared to historical experience with existing treatment options. The company now plans to share the data with global health authorities, including with the FDA under an accelerated approval pathway.”  

No Surprises Act news

  • Benefits Pro reports,
    • “Federal regulators today [July 10] said they are setting up a renewal process for the organizations that help health care providers and health care payers resolve No Surprises Act billing disputes.
    • One part of the new recertification process for the No Surprises Act “independent dispute resolution entities” could involve assessments of IDR entities’ fairness.
    • “Something officials may consider when looking at an recertification application is the ability of the IDR entity to “provide rationales for payment determinations meeting regulatory requirements,” according to a new set of answers to frequently asked questions about the IDR entity recertification process.
    • “Application reviewers will also look at an entity’s ability to handle a high volume of dispute assignments quickly and the entity’s ability to handle cases “accurately in accordance with statutory and regulatory timelines,” officials say.” * * *
    • “Regulators will post a list of the entities seeking recertification each week.”
  • Fierce Healthcare relates,
    • “A payer-backed group has launched a campaign challenging a bill that would build on the No Surprises Act.
    • “The Coalition Against Surprise Medical Billing (CASMB) announced on Monday that its “six-figure” campaign urges lawmakers to reject the No Surprises Act Enforcement Act, or H.R. 4710. This legislation, they argue, would “reward the actors misusing the [independent dispute resolution] process.” * * *
    • “The ad says that the No Surprises Act was passed “with good intentions,” but that Congress should focus future efforts on closing loopholes that allow for IDR abuse.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals court revived more than 500 lawsuits that allege Tylenol and generic acetaminophen can cause attention-deficit hyperactivity disorder or autism if taken during pregnancy.
    • “The Second U.S. Circuit Court of Appeals in Manhattan ruled that a trial judge had erred by excluding expert medical witnesses, offered by the plaintiffs, who were expected to testify that there was a link between Tylenol use during pregnancy and neurodevelopmental disorders such as autism and ADHD. The 3-0 decision sends the case back to the lower court for further proceedings.”
  • Healthcare Dive relates,
    • “More insurers are filing lawsuits in an attempt to hike their Medicare Advantage quality scores after a court decision earlier this year exposed federal regulators to a new line of legal attacks.
    • “SCAN Health Plan and Alignment Healthcare both sued the CMS in D.C. district court last week, arguing regulators robbed them of higher star ratings in the privatized Medicare program.” * * *
    • “The lawsuits from SCAN and Alignment — which are both represented by the law firm Latham & Watkins — allude to larger calls for reform and cite MedPAC’s censure of the star ratings system.
    • “The Star Ratings program went off the rails years ago,” reads SCAN’s complaint. “The system is undeniably broken.”
  • Beckers Payer Issues tells us,
    • “A federal judge has dismissed with prejudice a lawsuit from Blue Cross Blue Shield of Georgia that accused medical billing company HaloMD and two physician groups of conspiring to defraud the insurer through the No Surprises Act’s arbitration process.
    • “The insurer, part of Elevance Health, alleged in May 2025 that HaloMD, Sound Physicians Emergency Medicine of Georgia and Hospitalist Medicine Physicians of Georgia submitted false attestations of dispute eligibility, flooded the independent dispute resolution system with large volumes of ineligible disputes using AI to overwhelm program safeguards, and submitted inflated payment offers, including some that exceeded the providers’ own billed charges.
    • “In his July 10 decision, Judge Thomas Thrash Jr. wrote that the court lacked jurisdiction over most of the counts and ruled that the racketeering, state-law, ERISA and deceptive trade practice claims were “collateral attacks” on the arbitration determinations. 
    • “It is highly improbable to infer from these facts that there is a vast conspiracy of providers and IDREs that have conspired to defraud the Plaintiff of millions of dollars in thousands of NSA IDR proceedings over many years,” Judge Thrash wrote. “It is highly plausible to infer that the Plaintiff engages in a consistent practice of submitting lowball offers to out-of-network providers in an effort to maximize its profits.”

From the public health and medical / Rx research front,

  • Healio reports,
    • “There are now cyclosporiasis cases in more than half of U.S. states. 
    • “The outbreak will eventually “burn” itself out even if a source is not found, an expert said.” * * *
    • “For insight into the current surge, Healio checked in with David O. Freedman, MD, FIDSA, professor emeritus of infectious diseases at the University of Alabama at Birmingham.
      • “Healio: Are all the cyclosporiasis warnings warranted or is this outbreak overhyped? 
      • “Freedman: On a national basis, for healthy people, the odds of any illness are still relatively low. Hospitalization, if ill, is extremely rare in normal hosts and care is noninvasive, involving mostly intravenous fluids and initiation of the antibiotic course. No deaths have occurred to date.
      • “The word outbreak refers to rates of illness above a normal year. On a national basis the annual average number of cases is about 3,000, which we have not reached yet, although official reports take several weeks to catch up with individual cases submitted. This is partly due to diminished CDC capacity at the national level. A small number of individual states, notably Michigan, are now reporting case numbers at the outbreak level.
      • “Healio: Can you explain why it is so important to find a source for the outbreak?
      • “Freedman: It is likely that only a portion of the total cases are the result of a single source contamination event at a farm, processing plant or distribution center. The rest of the cases will be due to the dozens of small contamination events that occur each summer in the U.S.
      • “Finding one or a few major contamination events will greatly diminish subsequent case numbers. However, it is important to remember that the incubation period from ingestion to illness is 1 to 2 weeks, so even after identification of a source, the process of withdrawing the product from the supply chain, educating the public to avoid products already in homes and waiting for incubating cases to manifest will take several weeks.
      • “Healio: Do you feel the outbreak will only continue to spread until a source for it is identified? 
      • “Freedman: Not necessarily. Outbreaks like this tend to burn themselves out as shown by the baseline seasonality that runs from May to August. Contaminated products that entered the processing chain early in the season may have been grown under different circumstances than products entering later in the season.”
  • Bloomberg Law reports
    • “New York City officials identified dozens of buildings with Legionnaires’ bacteria in Manhattan’s Upper East Side, closing in on the source of an outbreak that has infected at least 46 people and hospitalized 22.
    • “The New York City Health Department tested the cooling towers of 183 buildings in neighborhoods encompassed by three zip codes — 10028, 10128 and 10075 — that are among the city’s wealthiest and most densely populated. Of the 31 with signs of bacterial contamination, 19 already have been cleaned, officials said on a call with reporters Friday. The remainder are set to be cleaned by Saturday [July 11].
    • “Officials sought to reassure those who live in or have visited the area in recent weeks, pointing out that they would have already been exposed to the bacteria and noting that most people don’t fall ill from it.
    • “It’s safe for folks to drink water, to bathe to shower to cook and to use their air conditioner,” NYC Health Commissioner Alister Martin said.”
  • Health Day tells us,
    • “U.S. Sen. Lindsey Graham, 71, died Saturday of an aortic dissection, a sudden tear in the body’s main artery
    • “The condition is often fatal; about half of patients reach the hospital, and roughly half of those survive
    • “High blood pressure is the leading risk factor, and sudden severe chest or back pain is the key warning sign.”
  • and
    • “Weight-loss meds are transforming obesity treatment.
    • “But when it comes to heart health, exercise may still be the game changer.
    • “The study shows that while medication supports weight maintenance, it is exercise — with or without medication — that improves vascular health,” said researcher Signe Torekov, a professor of biomedical sciences at the University of Copenhagen in Denmark.”
  • MedPage Today adds,
    • “A network meta-analysis backed weight-loss benefits with several GLP-1 receptor agonists, with less certainty for newer-generation agents.
    • “Two GLP-1 drugs were also associated with reduced heart failure risk, while subcutaneous semaglutide stood alone in being tied to a reduced risk of all-cause mortality and myocardial infarction.
    • “The evidence was less certain for a reduction in kidney failure or an improvement in quality of life beyond a subjective threshold.”
  • STAT News informs us,
    • “Health secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking psychiatric drugs, a medical practice known as deprescribing.
    • “Earlier this month, dozens of mental health professionals met with federal health officials to map out forthcoming clinical guidance they hope will help providers instruct patients on how to come off of antidepressant medications. While the Department of Health and Human Services has discussed plans to hold such a meeting, the outlines of the discussion haven’t been reported.
    • “During those talks, they reviewed guidance from European nations and worked on recommendations for nonmedication-based options for patients to address their mental health, such as therapy. A senior HHS official said they discussed gaps in the research around deprescribing SSRIs, including the side effects a person may experience, which vary depending on the drug and how long the person was on it, and how to recognize the difference between those side effects and a return of a patient’s depressive symptoms.”
  • MedPage adds,
    • “Modifiable dementia risk factors varied widely from country to country and a one-size-fits-all approach to dementia prevention will not work everywhere, data from 14 countries and regions showed.
    • “Both differences and similarities emerged in a global analysis of risks for 214,000 older adults, reported Emma Nichols, PhD, of the University of Southern California in Los Angeles, at the Alzheimer’s Association International Conference.
    • “Low education was a prevalent dementia risk factor for 85.6% of people in China compared with 12.0% of Americans, Nichols said. Obesity was a risk factor for 44.9% of older adults in the U.S., but only 13.3% of people in India.
    • “Despite differences in prevalence, similar factors — like cardiovascular risks (high cholesterol, hypertension, and diabetes) or risky behaviors (smoking and drinking) — tended to cluster together. Poor hearing, poor vision, and low education also co-occurred frequently.
    • “Risk factors often overlapped, with more than 50% of individuals having at least two risk factors, Nichols pointed out. In 11 countries and regions, the prevalence of at least four risk factors exceeded 20%.
    • “The findings were published in Lancet Healthy Longevity.
  • The CDC posted updated Core Elements of Outpatient Antibiotic Stewardship.
    • “Outpatient antibiotic stewardship programs promote appropriate antibiotic use to improve patient care and help combat antimicrobial resistance.
    • “The Core Elements of Outpatient Antibiotic Stewardship Programs provides a framework to improve antibiotic use and guide stewardship efforts for health systems, outpatient facilities, and prescribing clinicians.
    • “The guidance includes an assessment tool for evaluating stewardship efforts, a resource for measuring antibiotic use, and fact sheets that tailor stewardship strategies to specific outpatient settings.”
  • Per Health Day,
    • “Half as many young adults are misusing Adderall, Ritalin and other ADHD medications these days to help them remain alert at study or work, a new evidence review says.
    • “Misuse of ADHD stimulant meds among adults under 30 fell from 7.5% in 2016 to 3.7% in 2023, researchers report in the Journal of Clinical Psychopharmacology.
    • “We found a rapid drop in misuse of these medications, largely driven by a decline in Adderall misuse among young adults,” lead researcher Margaret Maglione said in a news release. She’s a project leader with the Southern California Evidence Review Center at the Keck School of Medicine of USC.”
  • Per MedTech Dive,
    • “Freenome said its updated blood-based colorectal cancer screening test met its primary and secondary endpoints in a pivotal validation study. Called SimpleScreen CRC, the new test showed improvement over an earlier version, particularly in detecting precancerous lesions. 
    • “Abbott, which inked a collaboration agreement with Freenome last August to bring SimpleScreen CRC to market, will commercialize the test when it gains Food and Drug Administration approval, Freenome said Thursday.
    • “The latest study results set up Abbott to be the dominant player in colorectal cancer screening, Evercore ISI analysts said in a note to clients.”

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

  • Healthcare Dive reports,
    • “Hospital dealmaking remained hot during the second quarter of 2026, extending a merger and acquisition rebound that has lately seen more mid-to-large independent systems in pursuit of financial security and growth, according to a new report. 
    • “Healthcare advisory firm Kaufman Hall, in its latest quarterly M&A report, tallied 18 new hospital transaction announcements from April through June. That’s well ahead of the eight logged during the same window last year, and comfortably above the average posted by the sector across the 2020s. 
    • “Total transacted revenue was $7.7 billion for the most recent quarter, which the firm noted was a major rebound from the $1.4 billion a year prior but falls well short of most prior years.” * * *
    • “Joining the M&A report was new hospital operating data from May suggesting a slight downturn in margins both month-to-month and compared to last year.
    • “Among the 1,300 hospitals Kaufman Hall taps for its monthly sector benchmarks, the firm reported a calendar year-to-date operating margin index of 2.9%, and a single-month operating margin index of 2.7% (both including health system allocations for the cost of shared services).
    • “The former of those reflects a 6% pullback from April’s data, and a 4% dip from May a year prior. The latter, year-to-date margin is a 5% decline from the preceding year as of the same point.” 
  • The American Hospital Association relates,
    • AHA Chair Marc Boom, M.D., presented three AHA awards during the 2026 Leadership Summit, recognizing hospitals and health systems for innovation, advancing health and excellence. See the news releases for more details on the winners and honorees.  
      • The 2026 Foster G. McGaw Prize for Excellence in Community Service, recognizing healthcare organizations for commitment to community service through programs that make communities healthier and more vital, was presented to Sky Lakes Medical Center in Klamath Falls, Ore.  
      • The 2026 Quest for Quality Prize, honoring hospitals and health systems that exemplify excellence in delivering high-quality, safe and patient-centered care, was presented to the Ralph H. Johnson VA Health System in Charlotte, N.C. 
      • The 2026 Circle of Life Award, recognizing outstanding programs in palliative and end-of-life care, was presented to Erie County Medical Center of Buffalo, N.Y., and the Geriatrics and Extended Care Hospice and Palliative Medicine Team of Orlando VA Health Care System in Orlando, Fla. 
  • Beckers Payer Issues tells us,
    • “Rejections of initial brand-name prescription attempts increased from 24.3% in 2018 to 40.7% in 2024, according to a July 9 JAMA study.
    • “Researchers from Baltimore-based Johns Hopkins Bloomberg School of Public Health and the American Enterprise Institute led the study. Looking across various types of coverage, they reviewed 1.17 million people’s pharmacy claims data for more than 2 million prescription attempts for brand-name drugs that lack generic alternatives. 
    • Here are six other things to know from the study:
      • 1. Overall, between 2018 and 2024, 32% of initial fill attempts were rejected.
      • 2. Of that share, the rejected molecule was ultimately filled within 90 days in 38.6% of cases, and a different drug in the same therapeutic class was filled for 13%. However, 48.4% had no medication filled in the same therapeutic class within that window.
      • 3. For those who ultimately received the same molecule or a therapeutic substitute, treatment was delayed an average of 12.2 days after that initial rejection.
      • 4. While 68% of the requests were paid after the initial fill attempt, 14.8% were rejected due to a formulary exclusion and 17.2% due to required prior authorization or step therapy.
      • 5. Rejections were steepest among exchange and Medicaid managed care plans, at 48.7% and 49.8%, respectively.
      • 6. Rejection rates were lower among Medicare plans.
  • Beckers Health IT informs us
    • “Technology services company UST is integrating Anthropic’s Claude into CarePath, a platform providers and payers use to run claims processing, care management and member services.
    • “Claude connects CarePath directly to underlying claims and care systems, turning fragmented health data into recommended next steps for care teams, per a July 9 Anthropic news release. Every action Claude recommends routes to a person for approval before it reaches a member, and the integration operates within the data controls healthcare requires.” * * *
    • “The company [UST] is betting that pairing Claude’s reasoning capabilities with human-approval workflows can move AI-led decisions out of pilot programs and into the production systems regulated industries depend on.”
  • Fierce Healthcare points out,
    • “Venture capital funding for digital health startups is on an upswing, fueled by an AI-powered rebound following a post-pandemic reset in 2023.
    • “Digital health companies raised $7.4 billion in the first half of 2026, up $1 billion compared to the first half of 2026 ($6.4 billion raised), according to Rock Health’s analysis of digital health deals in the first half of 2026. There were 244 deals in H1 2026. Investors poured $3.2 billion into the sector in Q2, just shy of Q1’s $4.2 billion.
    • “Building on trends from last year and into Q1 this year, capital is concentrating among a small number of megadeals as venture capital investors place their bets on innovative digital health companies, Rock Health researchers Ashwini Nagappan, Jason Lei and Maddie Knowles wrote.”

Weekend update

David Ermer–Agentic & Generative AI, Congress, Medicare, Obesity, U.S. Healthcare–

Simplicity is a virtue.

“National Simplicity Day on July 12 honors transcendentalist Henry David Thoreau, a man who advocated a life of simplicity. A man of many talents and skills, Thoreau was a supporter of living the simple life and encouraging others to do the same.”

Clarity Benefit Solutions offers the following pledge; “I pledge to make a conscious effort to simplify the administration, service, and user experience for benefits this year because I believe in the value and power of simplicity in a complicated world. Let’s let simplicity be our new normal.”

OPM should make good on this pledge by adopting the June 2026 recommendations that the AFHO trade association offered.

From Washington, DC,

  • Roll Call discusses this week’s anticipated events on Capitol Hill.
  • 24 Wall St reminds FEHB annuitants,
    • Skipping [Medicare] Part D for two years locks in a permanent 24% monthly surcharge worth roughly $113 annually on top of any plan premium.
    • The surcharge grows every year because it tracks the national base premium, which jumped 6% in 2026 alone, compounding lifetime costs into the thousands.
    • A 63-day gap without creditable coverage triggers the penalty even with no medications, making enrollment in the cheapest Part D plan the only sure defense.

From the U.S. public health and medical / Rx research front.

  • The Cleveland Clinic Newsletter tells us,
    • “As thousands of the world’s leading Alzheimer’s researchers, clinicians, and policymakers convene this week in London for the Alzheimer’s Association International Conference 2026, we have an opportunity to change the course of history for women’s health by focusing on women’s brains.
    • “For too long, women’s health has been compartmentalized into reproductive health, breast cancer, heart health and bone health. Missing from the conversation has been a focus on the organ that regulates every part of a woman’s body: the brain. That must end. Women’s health is brain health, and brain health is the core of women’s health.
    • “Women make up nearly two-thirds of those diagnosed with Alzheimer’s. Women are also far more likely to provide the unpaid care that keeps families and care systems from collapse. Yet women’s brains remain largely under-studied, under-discussed, and underprioritized in research, risk reduction and care.”
    • “The world can no longer afford to ignore [these issues].”
  • Onco Daily relates.
    • ‘Breast cancer incidence is increasing rapidly among Asian American, Native Hawaiian, and Pacific Islander women in the United States, with especially concerning trends in early-onset disease, distant-stage diagnosis, and aggressive molecular subtypes.
    • “A new population-based study published in JAMA Network Open examined invasive breast cancer incidence trends from 2000 to 2022 across disaggregated Asian American, Native Hawaiian, and Pacific Islander ethnic groups.
    • “The study included 148,608 Asian American, Native Hawaiian, and Pacific Islander females diagnosed with invasive breast cancer using National Cancer Institute SEER Program data from 14 US states.
    • “The findings challenge the older assumption that breast cancer incidence is uniformly lower among Asian American populations. They also show why grouping Asian American, Native Hawaiian, and Pacific Islander communities into one category can hide important differences in risk, stage, and subtype.”
  • The American Heart Association informs us,
    • “Gum disease bacteria may spur calcium buildup in the heart’s aortic valve, leading to a common and serious heart valve disease, according to preliminary, independent research presented at the American Heart Association’s Basic Cardiovascular Sciences Scientific Sessions 2026. The meeting, in Boston, July 13-16, 2026, is one of the largest meetings globally dedicated to fundamental and translational research in cardiovascular science.
    • “According to the American Heart Association, calcific aortic valve stenosis (CAVS) occurs when the aortic valve thickens and calcifies, restricting blood flow from the heart to the rest of the body. In early stages, there may be no symptoms; however, as the condition progresses, it can cause fatigue, chest pain, shortness of breath, fainting, heart failure and sometimes premature death. Standard treatment for severe CAVS is valve replacement surgery.
    • “This study identifies a potential biological pathway linking chronic oral gum disease and infection to calcific aortic valve stenosis.” * * *
    • “The American Heart Association’s Healthy Smiles, Healthy Hearts™ initiative provides dental care teams with professional education highlighting the connection between oral health and heart health, a standard blood pressure screening and referral guide for patients in dental settings, and educational materials for patients to help improve both their oral and heart health.
    • “The study has limitations because its findings have not been confirmed in people. The researchers have started a clinical study to further evaluate the link between gum disease and CAVS.”
  • U.S. Medicine points out,
    • “A top priority for researchers who study aging is how to identify and treat frailty, even though there are no established therapeutic interventions for the condition.
    • “That’s why a new study of U.S. veterans is considered so important. It found that initiation of statins was associated with a significantly lower risk of incident frailty or death among the older participants, including those who were pre-frail at baseline.
    • “There are currently no approved medications specifically to prevent frailty,” explained lead author Saadia Qazi, DO, MPH, MSc, a cardiologist at the VA Boston Healthcare System and in the Division of Aging in Mass General Brigham’s Department of Medicine. “Our findings suggest that statins may offer an important opportunity to reduce the risk of frailty and help people preserve their health and independence as they age.”

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

  • Out of the Beltway informs us, “The Economist surveys recent research and concludes, “An ageing society might not cost too much.”
    • “Spending on health care depends on how much it costs to provide and how much treatment is needed. Generally, the former has increased over time. Economists attribute this to Baumol’s cost disease, diagnosed by William Baumol, an American economist. Technologically intensive sectors (think of manufacturing or software development) get more productive. Labour-intensive service sectors do not. A doctor’s consultation takes roughly as long as it did a century ago. Yet physicians’ pay must match increases in faster-growing skilled industries, or all the doctors will go to work in tech. (Baumol pointed out that a string quartet still took 45 minutes to perform a Schubert work,but was paid vastly more than when the composer was alive.) […]
    • “Two new papers from the National Bureau of Economic Research, a repository of economic thought, suggest that the vision of health care gobbling up tax revenues may not come to pass. In the first, David Cutler and Lev Klarnet, both of Harvard University, observe that in 2024 America spent $1trn less on health care than official forecasts from 2010. The second is by Liran Einav, of Stanford University, and Amy Finkelstein, of the Massachusetts Institute of Technology (MIT). Using a survey of users of Medicare, America’s system of health insurance for the old, they find that, whereas expected lifetime spending on Social Security (ie, pensions) rose by 14% between 1993 and 2017, the expected cost of Medicare increased by only 6%. That is partly because elderly Americans have been collecting their pensions for longer but spending less time seriously ill.
    • “The papers point to improvements on both sides of the equation. Start with the cost of providing health care in hospitals. Messrs Cutler and Klarnet point out that, between 2000 and 2010, it consistently rose by around 2.3 percentage points above inflation—but that later something changed. Between 2011 and 2024 hospital costs rose by only 0.5 percentage points more than overall prices. Technology has played a role. Technological improvements in health care come in two types: some are adopted because economies get richer and can afford to treat new things; others make it cheaper to provide the same outcomes. For much of the past century, the first type dominated the second. Now, it seems the second type has taken over. Baumol’s cost disease turned out to be curable.”
  • McKinsey and Co. considers that “The consumer is changing fast. Four trends—the tech-driven path to purchase, the health revolution, the experience economy, and the resourceful consumer—will redefine the sector. Will brands keep up?”
  • MedCity News notes that “Healthcare and AI are in Need of Relationship Counseling.”
    • “Performing well in controlled settings is only part of the picture, the harder question is whether AI is being integrated into clinical workflows in ways that keep responsibility, authority, and accountability properly aligned.”
  • The Wall Street Journal reports.
    • “Eating-disorder therapists say patients are increasingly using chatbots for diet and exercise advice, sometimes challenging professional guidance.
    • “Therapists warn that chatbot advice delivered without clinical context can be dangerous and delay vital treatment for eating disorders.
    • “AI companies say they are working to improve how their models recognize and respond to signs of disordered eating.’

Notable Death

  • The Frederick (MD) News Post reports,
    • “Martha Lillard had just turned 5 when she was diagnosed with polio and depended on an iron lung to live. She died June 26 in Oklahoma, the last U.S. polio patient who used the machine, her sister said. She was 78.
    • “They told her she wasn’t supposed to live past 20 years old,” Lillard’s younger sister, Cindy McVey, told The Associated Press on Friday. “She had the enthusiasm and the drive to continue living and make the best of her life.” * * *
    • “McVey described her sister as artistic and creative. She wrote poems and composed songs. She wrote her own obituary, which is now posted online by a funeral home. She described being a Humane Society volunteer. “She was an avid Beagle lover and assisted in animal rescue as a cross poster on Facebook,” Lillard wrote.”
  • RIP


Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the renewed war with Iran front,

  • Dark Reading offers an opinion piece explaining that “Iran’s Cyber Crosshairs Focus Beyond Critical Infrastructure.”
    • “Obscurity isn’t a defense. If your company has any Internet-facing vulnerability, you’re at risk from multiple threats.” * * *
    • “The groups behind recent attacks, including Handala, Ababil of Minab, and others operating within Iran’s cyber-influence ecosystem, cloak themselves in the mask of cyber activism, or “hacktivism.” They are largely opportunistic. They aren’t specifically hunting targets; they are on “Shodan Safaris” hunting easily exploited vulnerabilities or insecure systems. A law firm or logistics hub with an exposed programmable logic controller or an unpatched VPN is an easy, appealing target.
    • “Many companies don’t realize how much of their infrastructure is externally accessible, or how little it takes to exploit what’s exposed. Handala, which the US Justice Department has attributed to Iran’s Ministry of Intelligence and Security, remotely wiped over 200,000 hosts in an attack on Stryker, a medical device manufacturer, in March. The incident disrupted manufacturing and impacted their first-quarter earnings. More recently, Ababil of Minab compromised Vyncs, a GPS tracking platform used across the logistics sector, taking systems offline and defacing its website. In the Stryker incident, the attack was likely made possible through credentials stolen via commodity malware and provided for sale via illicit channels — emphasizing the opportunistic nature of these events.”
  • Security Week adds,
    • “An Iran-linked advanced persistent threat (APT) actor has been using a modular command-and-control (C&C) framework in recent attacks targeting organizations in Israel, Check Point reports.
    • “Tracked as Cavern Manticore, the APT focuses on government entities and IT providers, and appears linked to Iran’s MOIS (Ministry of Intelligence and Security), with possible ties to the OilRig subgroup Lyceum (also known as Hexane and SiameseKitten).
    • ‘Cavern Manticore’s C&C framework includes an adaptable toolset built using .NET, with various compilation formats used across components, used as an anti-analysis layer.”

From the Project Glasswing front,

  • Crypto Briefing reports,
    • “The U.S. government has begun utilizing AI technology developed by Anthropic to identify vulnerabilities in its software systems. This initiative, part of Project Glasswing, leverages Anthropic’s Mythos model to detect bugs within hours, a significant improvement over traditional methods. Despite previous concerns over security risks associated with the Mythos model, its deployment underscores the government’s commitment to strengthening cybersecurity measures. The move is seen as a strategic effort to protect critical infrastructure and enhance national security.”
  • Bleeping Computer adds,
    • Microsoft says Windows users should expect to see an increase in security updates as the company increasingly relies on artificial intelligence to discover vulnerabilities in its codebase.
    • In a blog post published today, Microsoft said advances in AI have significantly accelerated vulnerability discovery, allowing engineers to identify more security issues before they can be exploited in zero-day attacks.
    • “The pace of vulnerability discovery is changing with advances in AI making it possible to find more issues, faster, across more code, with new mechanisms that can accelerate both discovery and analysis,”  Microsoft said. * * *
    • “This announcement comes two days [July 8] after Reuters reported that the U.S. Cybersecurity and Infrastructure Security Agency (CISA) has begun using Anthropic’s Fable AI model to scan government software for vulnerabilities that cybercriminals or foreign intelligence services could exploit.
    • “According to the report, the AI-assisted code audits have already uncovered numerous vulnerabilities, though officials did not disclose how many or provide details on their severity.”
  • SC Media lets us know “what our industry learned the past 90 days since the Mythos announcement.”
    • “For years, security leaders have discussed the possibility that AI would eventually accelerate offensive cyber operations. Mythos transformed that discussion from a future-looking hypothesis into an immediate operational concern.
    • “Over the past three months, the industry has begun adjusting to a new reality. We no longer view AI simply as a productivity tool that helps developers write code or assists analysts with investigations. It’s emerged as a force multiplier for vulnerability discovery, capable of identifying weaknesses at a pace that challenges traditional security workflows. As the time between vulnerability discovery and exploitation shrinks, organizations are now forced to rethink long-standing assumptions about patch management, vulnerability prioritization, and cyber defense.
    • “This shift extends well beyond one AI model or one vendor. Whether organizations use commercial frontier models, open-weight alternatives, or internally developed AI systems, the underlying trend remains the same: AI has dramatically compressed the window defenders have to identify, validate, and remediate software flaws before attackers can weaponize them. In many ways, the security industry has entered an era in which the speed of decision-making may become just as important as the quality of detection.”

From the cybersecurity policy and law enforcement front,

  • On July 3, the Office of Management and Budget’s Office for Information and Regulatory Affairs posted the federal government’s 2026 unified regulatory agenda.
    • Fierce Healthcare tells us,
      • “Federal regulators have delayed a major overhaul of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, pushing back final action on the rule by a year.
      • “The Department of Health and Human Services (HHS) had proposed a May 2026 release for a final rule that makes significant changes to the HIPAA Security Rule and marks the first major update to the 23-year-old rule in more than 10 years.
      • “The U.S. Office of Management and Budget (OMB) website was updated and indicates that the final rule was pushed back to July 2027.”
    • Federal News Network lets us know,
      • “[The unified agenda] shows that the Cybersecurity and Infrastructure Security Agency expects to issue a final rule for the Cyber Incident Reporting for Critical Infrastructure Act in September 2026. Earlier this summer, CISA held a series of townhalls to get some final feedback on the regulations.” * * *
      • “Meanwhile, the Unified Agenda also shows that a federal contracting rule that standardizes cybersecurity requirements for unclassified IT systems will also be finalized in September 2026.
      • “The rule “will ensure federal information systems are better positioned to protect from cybersecurity threats by standardizing common cybersecurity contractual requirements across agencies for unclassified federal information systems,” according to the regulatory preview.
      • “And another federal contracting rule on “cyber threat and incident reporting and information sharing” is also projected to be finalized in September, the Unified Agenda shows.
      • “Both the CUI rule and the incident reporting rule have been long anticipated, with proposed rules dating back to 2023. They each represent landmark rules for the government contracting community, which is also grappling with the roll out of the Defense Department’s Cybersecurity Maturity Model Certification (CMMC) requirements.
      • “The CMMC regulations went into effect late last year, but DoD has been slowly ramping up the requirements for third-party audits. This November, however, the requirement for a third-party CMMC assessment is expected to become standard in all applicable contracts.
      • “DoD also expects to shortly issue more details on how the cybersecurity standards that underpin CMMC will be updated.
      • “The Unified Agenda shows that this month, DoD will adopt an interim final rule for the CMMC program that details the deadline for shifting to the National Institute of Standards and Technology Special Publication 800-171 Revision 3. Currently, CMMC assessments are tied to Revision 2 of the NIST standards.”
  • Fedscoop informs us,
    • “Greg Barbaccia is stepping down as federal CIO and leaving government at the end of August, he said in an email to the CIO Council Tuesday [June 7, 026].
    • “I’m writing to share that I’ve made the difficult decision to leave government, and my time as Federal CIO is coming to an end,” Barbaccia wrote to CIOs on the council in his email, obtained by FedScoop. 
    • “Barbaccia, who joined the Trump administration as its top IT official in January 2025, said his last day in the role will be Aug. 31.
    • “Barbaccia’s departure comes just months after he brought on former Department of Education CIO Thomas Flagg to be his deputy. Flagg would be the default acting official with Barbaccia’s departure, a government chief information officer told FedScoop on the condition of anonymity to be more candid.”
  • Cyberscoop observes,
    • “The AI-focused executive order President Donald Trump signed last monthgave the Treasury Department, the National Security Agency, and the Cybersecurity and Infrastructure Security Agency (CISA) 30 days to establish a new “AI cybersecurity clearinghouse.” The deadline passed last week.
    • “The clearinghouse is meant to coordinate the scanning, discovery, and validation of software vulnerabilities in critical infrastructure, and then prioritize how those vulnerabilities get patched and distributed.
    • “It’s the right problem to solve. The question now is whether what is created will actually solve it.”
  • and
    • “A major credential leak spurred the Cybersecurity and Infrastructure Security Agency to strengthen protections for its sensitive materials, improve how researchers can report agency vulnerabilities and develop plans for similar incidents, the agency said in a forensic report released Thursday.
    • The blog post outlines CISA’s response to the leak that the researcher who discovered it in May called one of the worst he had ever seen, which also drew congressional scrutiny.”
  • Cyberscoop adds,
    • “”A former ransomware negotiator for DigitalMint was sentenced to 70 months in jail for deceiving his employer’s clients and conspiring with ransomware affiliates to extort a combined $75.3 million from five U.S. companies he was entrusted to aid during their moments of extreme crisis, the Justice Department said Thursday. 
    • Angelo John Martino III shared confidential information he gained from his work as a ransomware negotiator, including victim organizations’ negotiating positions and insurance policy limits, to extract the maximum payment for himself and other BlackCat affiliates he colluded with in backchannels.”
  • and
    • “An Armenian national who was extradited from Ukraine to the United States last year pleaded guilty to participating in a series of attacks in 2019 and 2020 involving Ryuk ransomware, the Justice Department said Thursday.
    • “Karen Serobovich Vardanyan pleaded guilty to computer fraud and conspiracy to commit fraud and extortion. He agreed to pay nearly $1.2 million million in restitution and faces up to 15 years in jail.
    • “The 34-year-old admitted to participating in cybercrime from November 2019 to April 2020 when he and his co-conspirators deployed Ryuk ransomware against three U.S.-based organizations while living in Ukraine and Russia.”

From the cybersecurity breaches and vulnerabilities front,

  • Dark Reading reports,
    • “In February, a ransomware attack against the University of Mississippi Medical Center disrupted operations for more than two weeks. In March, a cyberattack on German medical-billing provider Unimed, which services 95% of the nation’s university hospitals and more than half of large clinics, resulted in the theft of sensitive health data for tens of thousands of patients.
    • “In the first half of 2026, cyberattacks on the healthcare sector jumped 14%, slightly more than the overall increase of 11% across all industries, according to data from technology research firm Comparitech. While healthcare providers — such as hospitals and doctors’ offices — saw a moderate rise in attacks, healthcare businesses suffered a significant increase of 35% compared with the second half of 2025 and 110% compared with the same six months from the previous year.
    • “Much of the shift in focus is likely because attackers have recognized that compromising a single provider can provide access to multiple hospitals, says Rebecca Moody, head of data research at Comparitech.”
  • Cybersecurity Dive relates,
    • “A threat actor claims to have stolen a vast trove of sensitive data from the consulting giant Accenture in a recent cyberattack.
    • “The compromised data includes source code, Microsoft Azure personal access tokens, RSA encryption keys and SSH keys, a hacker calling themselves “888” said in a dark-web post shared by Bleeping Computer.
    • “The actor says they hacked roughly 35GB of data from Accenture during the intrusion, which occurred in early July.
    • “Accenture downplayed the incident in a statement to Cybersecurity Dive.
    • “We are aware of this isolated matter and we have remediated its source,” spokesperson Peter Soh said. “There is no impact to Accenture operations and service delivery.”
    • “The stolen data could put Accenture and its clients at significant risk of further attacks. “Source code can help attackers understand internal application logic, identify weak implementation patterns, and search for hardcoded secrets or exploitable paths in custom systems,” the threat intelligence firm SOCRadar said in an analysis of the incident. Meanwhile, the exposed access keys could let hackers roam freely through code repositories and cloud storage services.”
  • and
    • “AssuranceAmerica, a closely held provider of auto and renters insurance, was the target of a cyberattack earlier this year that impacted more than 6.9 million customers, according to state regulatory filings. 
    • “The Atlanta-based firm said the incident was detected on March 17, stemming from an attack that targeted one of its employees a day earlier, according to a filing with the California Attorney General’s office. 
    • “An investigation found an unauthorized party gained access to the company’s IT department and copied a number of data files. The company said it notified law enforcement about the attack. 
    • “According to a filing with the Maine Attorney General’s office, the breach involved more than 6.9 million people. This included nearly 880 people within the state of Maine. The Maine AG discontinued posting new notices on its public site in June after its breach reporting system was the target of an attack.”
  • and
    • “An initial access broker weaponized a critical vulnerability known as CitrixBleed 2 in a series of attacks during the first half of 2026 across multiple organizations, according to a report released Thursday [July 9] by the security company Huntress. 
    • “After exploiting the vulnerability, the hackers escalated privileges, created rogue local administrator accounts and established persistence with legitimate remote access tools, including ScreenConnect and Zoho Assist. 
    • “About a half-dozen cases between January and June followed a consistent playbook. In the most advanced case, the attackers deployed DragonForce ransomware, Huntress researchers said.”
  • Healthcare Dive adds,
    • “AdaptHealth disclosed last week that a recent cyberattack resulted in patient data being stolen.
    • “A threat actor gained unauthorized access to company systems through a social engineering attack and exfiltrated data, including certain personally identifiable information, protected health information of patients and stored password files associated with insurance billing, according to a July 2 filing with the Securities and Exchange Commission.
    • “Based on information obtained to date, AdaptHealth believes that the threat actor gained unauthorized access to certain cloud-based business applications, including internal patient management systems and document storage platforms. The company also confirmed that certain external electronic health record system portals were accessed.”
  • CISA added six known exploited vulnerabilities to its catalog this week.
    • July 7, 2026 (two releases; “Per BOD 26-04, federal agencies are required to patch all four security weaknesses by July 10.”)
      • CVE-2026-48282 Adobe ColdFusion Path Traversal Vulnerability
      • CVE-2026-48908 JoomShaper SP Page Builder Unrestricted Upload of File with Dangerous Type Vulnerability
      • CVE-2026-55255 Langflow Authorization Bypass Through User-Controlled Key Vulnerability  
      • CVE-2026-56290 Joomlack Page Builder Improper Access Control Vulnerability
        • Security Week discusses these KVEs here.
    • July 10, 2026
      • CVE-2026-48939 iCagenda Unrestricted Upload of File with Dangerous Type Vulnerability
      • CVE-2026-56291 Balbooa Forms Unrestricted Upload of File with Dangerous Type Vulnerability
        • Mallory discusses these KVEs here.
  • Dark Reading adds,
    • “Microsoft has tackled yet another zero-day vulnerability published by a disgruntled security researcher with a vendetta against the software giant.
    • “On Wednesday, Microsoft issued an out-of-band patch for RoguePlanet, an elevation-of-privilege vulnerability in Windows Defender, tracked as CVE-2026-50656. The high-severity flaw, which received a 7.8 CVSS score from Microsoft, could allow an attacker to escalate privileges on a Windows device from a basic user to the highest SYSTEM-level access, which would give them complete control over the device.” * * *
      “Despite a public exploit being available for RoguePlanet, it’s unclear if the vulnerability has been exploited in the wild. Microsoft’s updated advisory states the flaw has not been exploited, and CISA has not added CVE-2026-50656 to its Known Exploited Vulnerabilities (KEV) catalog. Qualys, meanwhile, published a threat report on June 18 stating that RoguePlanet has been “exploited in attacks,” though no details were provided.”
  • Security Week relates,
    • “Organizations across multiple sectors have been targeted in a vishing campaign aimed at harvesting Microsoft 365 credentials, Okta warns.
    • “The campaign started in April and has involved voice calls directing the victims to fake Microsoft Entra ID login pages under the pretense that they need to register a new passkey.
    • “Tracked as O-UNC-066 and also known as CL-CRI-1147 and Pink, the hacking group has been targeting automotive, aviation, construction, food and beverage, healthcare, and technology organizations, mainly for data extortion.
    • “As part of the observed attacks, the threat actor has been registering domains incorporating the word ‘passkey’, and has been directing victims to pages that closely mirror the Microsoft passkey enrollment process.
    • “It appears engineered to convince a targeted user they are in the process of enrolling a passkey with Microsoft, while the threat actor simultaneously registers their own passkey in the targeted user’s Microsoft account,” Okta says.”
  • and
    • “A critical prompt injection vulnerability in GitHub Agentic Workflows could allow unauthenticated attackers to leak private repository data, Noma Labs warns.
    • “GitHub Agentic Workflows allows users to write workflows in natural language using markdown files that an AI agent will use as GitHub Actions, thus automating the interaction with code repositories.
    • “Because of the security defect, named GitLost, unauthenticated attackers can hide indirect prompts in crafted GitHub Issues posted on the public repositories of an organization that also maintains private repositories, and the AI agent will follow the instructions.”

From the ransomware front,

  • Cybersecurity Dive reports,
    • “Ransomware activity grew slightly between the first and second quarters of 2026 but significantly year over year, and there were more hacker groups active during April, May and June than in any previous quarter, researchers said on Thursday [July 9].
    • “Cybercrime actors claimed breaches of 2,279 victims in Q2 2026, a 7% increase over Q1 2026 but a 43% year-over-year increase compared with Q2 2025, GuidePoint Security said in a quarterly report.
    • “The Qilin ransomware gang led the quarter, accounting for 13% of attacks, but the relatively new group The Gentlemen has grown quickly and now accounts for almost as much activity, GuidePoint said.” * * *
    • “Qilin, The Gentlemen, Akira and DragonForce compromise what GuidePoint calls the “four-headed monster” of high-volume ransomware groups. The lack of a “singular monolithic figure” could make the ransomware community more resilient to law-enforcement takedowns, the security firm said, because there are now “multiple franchises poised to absorb displaced affiliates if another were to disappear overnight.”
  • Tech Crunch relates,
    • “Last week, researchers at cloud security firm Sysdig said they’d documented the first known case of “agentic ransomware.” It was an extortion operation, dubbed JadePuffer, in which an AI agent — not a human — handled the technical execution of a real-world cyberattack from start to finish. The agent broke into a vulnerable server, stole credentials, moved through the target’s network, encrypted files, and even wrote its own ransom note, adapting to obstacles along the way like a human hacker would. Coverage of the operation described it as run “without any human oversight,” with “no human at the keyboard.”
    • “That’s not quite the full picture. In an interview on Monday with CyberScoop, Sysdig’s Michael Clark, the company’s senior director of threat research, clarified that a human was still very much involved — just not in the technical execution. “A human still set up and pointed the operation and provisioned the infrastructure behind it, the command-and-control server, the staging server used for the stolen data and chose a victim,” Clark said. The credentials used to break into the victim’s database, he added, weren’t harvested by the AI agent itself; someone obtained them separately, through a prior compromise, and handed them to the operation.
    • “None of this contradicts Sysdig’s original claim, and the technical details of the attack remain notable on their own — wild, even. The agent got in through a known bug in Langflow, a popular open source tool for building LLM apps, then moved on to a production MySQL server and exploited another known flaw to gain admin access. It encrypted over 1,300 configuration records and not only left behind a ransom note that it wrote itself but it left a Bitcoin address where the ransom could be sent. Sysdig hasn’t disclosed who was targeted.”
  • Dark Reading tells us,
    • “A newly rebranded ransomware outfit is sneaking malware into American organizations using a malicious yet Microsoft-approved driver.
    • “Researchers at Symantec recently observed a cyberattack from a group known as “Hyadina.” Hyadina is a 4-year-old ransomware-as-a-service (RaaS) operation with a new locker, “GodDamn,” an iteration on its previous lockers, “Beast” and “Monster.” It typically attacks American organizations, and it also has a distinct distaste for former Soviet countries. Its targets have spanned sectors that include healthcare, manufacturing, education, and wherever else it finds opportunity.
    • In a recent case against an unidentified organization, Hyadina used a smorgasbord of dual-use hacking tools, including legitimate remote monitoring and management (RMM) software, and more than a dozen penetration testing programs. The real kicker, though, was a malicious program with kernel access on Windows, capable of killing any and all processes, including security software.

From the cybersecurity business and defenses front,

  • Cybersecurity Dive reports,
    • “U.S. companies are merging cyber risk issues into their overall enterprise risk strategy, at a time when AI adoption and business resilience are leading to significant shifts in business priorities, according to a report released Tuesday [July 7] by Information Services Group, a technology research and advisory firm.
    • “Cybersecurity is increasingly seen as a business-critical concern, as companies accelerate their adoption of agentic AI and transform much of their technology and data infrastructure to hybrid or multicloud environments. 
    • “Enterprise leaders are closely integrating cyber spending decisions with overall IT strategy. In addition, C-suite and board members are taking greater accountability for business continuity, financial exposure and regulatory compliance.”
  • Info-Security Magazine relates,
    • “Chris Betz has officially taken the helm as the new CISO of Google Cloud. Transitioning from his previous role as Google’s VP of infrastructure security, Betz is stepping up to lead the company’s security posture at a critical turning point in the industry.
    • “In his very first interview since assuming the CISO title [which is found in the article], he shared his vision on the role generative AI will play in defending global enterprises.
    • “Coinciding with his transition, Betz published a key blog post on the Google Cloud blog titled Cloud CISO Perspectives: The 4 lessons that guided AI threat defense. In the article, he lays out Google’s playbook for using AI to defend against AI, advocating for a multi-model approach, robust security harnesses and the irreplaceable value of human expertise in modern cyber defense.”
  • Tech Target offers “a roadmap to zero trust maturity.”
    • “Transforming an organization to take on a zero-trust posture is no small affair. A phased, thoughtful approach can bolster security while supporting business outcomes.”
    • “Zero trust is not a product, control or single technology deployment; it’s a strategic architecture and operating model designed to reduce risk and improve the security posture of organizations that have traditional, perimeter-based security models. Perimeter-based models — which assume clearly defined “inside” and “outside” boundaries — fail to address modern threats because they were designed for a world that no longer exists.
    • “Zero trust relies on three foundational principles:
      • “Explicit verification. Every access request is authenticated and authorized using components such as user identity, device health, location and behavior.
      • “Least-privilege access enforcement. Users and devices receive only the minimum access required, and only for as long as needed.
      • “Assume breach. Security operates under the assumption that attackers are already present, with controls designed to limit access and damage.”
  • and sugggests an approach for “evaluating secure enterprise browsers vs. security plugins
    • “Malicious actors have long targeted and exploited browser vulnerabilities. The widespread adoption of AI increases the risk, forcing CISOs to reevaluate browser security options.” * * *
    • “In this moment of renewed attention to browser security and the risks of it failing, CISOs face two options for improving browser security: deploying secure enterprise browsers and deploying browser security plugins.”
  • Here is a link to Dark Reading’s CISO Corner.

Thursday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • STAT News reports,
    • ‘ARPA-H, the U.S.’ “moonshot” agency for health research, announced Thursday that it will spend up to $160 million to push forward custom gene editing treatments for a spate of rare diseases. 
    • ‘The program, called THRIVE, will back seven different teams pursuing various groups of conditions affecting different organ systems. 
    • “Each team has a deadline of starting clinical trials by year three of the program, although some may start much sooner.” * * *
    • “Each of the groups will work with a partner, such as a biotech company or contract manufacturer, or multiple partners to assure they can manufacture the program to Food and Drug Administration standards.”
  • Beckers Hospital Review relates,
    • “Peptides have become one of the most closely watched regulatory questions in healthcare this summer, with a federal advisory committee vote set for July 23-24 that could reshape what’s legally available to prescribers, wellness clinics and patients nationwide.
    • “What are peptides?
      • Peptides are short chains of amino acids that often serve as signaling molecules for physiological functions in the body, including tissue repair, metabolism and inflammation. Some peptides, like insulin and semaglutide, the active ingredient in Ozempic and Wegovy, are FDA-approved drugs. Others — including BPC-157, TB-500 and a handful of others marketed for injury recovery, weight loss, sleep and anti-aging — have circulated for years through wellness clinics, medical spas and online retailers without ever being FDA-approved or added to the list of substances legally allowed in pharmacy compounding. 
      • “That distinction matters because of how compounding law works. Under Section 503A of the Food, Drug and Cosmetic Act, a licensed pharmacy can only compound a drug for an individual patient using a bulk substance if it’s FDA-approved, has a recognized USP monograph, or appears on the FDA’s 503A Bulks List. If a peptide isn’t on that list, pharmacies generally can’t legally compound it — which is exactly the question now in front of regulators. 
    • “The upcoming vote 
      • “The FDA’s Pharmacy Compounding Advisory Committee meets July 23-24 to decide whether seven peptides should be added to the 503A bulks list: BPC-157, KPV, TB-500 and MOTs-C, Emideltide (also called DSIP), Semax and Epitalon. The committee’s recommendation is non-binding, but the FDA has historically followed it.”
  • Tammy Flanagan, writing in Govexec, explains OPM’s new all-digital federal retirement benefit application process.
  • Per an HHS news release,
    • “President Donald J. Trump signed an Emergency Declaration for the Northern Mariana Islands and the Territory of Guam, and Secretary Robert F. Kennedy, Jr. has declared a public health emergency to address the consequences of Typhoon Bavi. Under these circumstances, the Secretary has also exercised the authority to waive sanctions and penalties against a covered hospital that does not comply with the following provisions of the HIPAA Privacy Rule:
      • the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
      • the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
      • the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
      • the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
      • the patient’s right to request confidential communications. See 45 CFR 164.522(b).
    • “When the Secretary issues such a waiver, it only applies: (1) in the emergency area and for the emergency period identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.”

From the Food and Drug Administration front,

  • USA Today reports,
    • “If headlines about heavy metals in tampons raised concerns, the Food and Drug Administration says there’s some reassuring news.
    • “A new agency study found trace amounts of metals including arsenic, cadmium and lead in tampons sold in the U.S., but concluded the levels released during use are too low to pose a health risk.
    • “The findings are the FDA’s latest response to a widely publicized 2024 study that detected metals in popular tampon brands and sparked questions about possible health effects. After analyzing 11 tampon products from six brands, FDA researchers found that while metals can be detected in the products, exposure during normal use remains far below levels considered harmful.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has won Food and Drug Administration approval for a catheter that delivers radiofrequency and pulsed field energy to treat atrial fibrillation.
    • “The approval, which J&J disclosed Wednesday, covers the Dual Energy Thermocool Smarttouch SF Platform. J&J already had approval for a single, radiofrequency energy version of the device.
    • “Integrated into the company’s Carto mapping system, the dual-energy catheter is part of J&J’s push to leverage its electrophysiology strength to reverse market share losses triggered by PFA.”
  • The American Hospital Association News relates,
    • “The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. Medline has instructed impacted customers to remove the recalled convenience kits from where they are used or sold. The company said that other components within the convenience kits may still be used.” 
  • BioPharma Dive cautions,
    • “The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia.
    • “Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the Food and Drug Administration and the National Institutes of Health, focuses on modernizing regulations and processes, improving patient access and participation, and enhancing the use of data and technology to streamline the regulatory process.
    • “It’s the latest in a series of actions aimed at supporting drug research. But whether the new reforms will make a meaningful impact is an open question.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “CVS Health and its embattled Omnicare unit have agreed to pay $440 million to the Department of Justice to satisfy a nearly $950 million judgment against the company as part of an ongoing fraud case.
    • “In April 2025, a federal jury ruled that Omnicare submitted more than 3.3 million fraudulent prescription claims between 2010 and 2018, earning $135.6 million in overpayments as a result. Then, in July 2025, a judge ordered Omnicare to pay $948.8 million in fees and damages as part of the case.
    • “In the new court docs, CVS said that it has agreed to make an initial $130 million payment within 14 days of the agreement’s effective date. The remaining $310 million must be paid out by March 15, 2028.
    • “The agreement with DOJ is contingent on the closure of Omnicare’s sale to GenieRx Holdings, according to the filing. As it navigated the legal fallout of the False Claims Act case, Omnicare filed for bankruptcy in September 2025, and CVS announced plans to sell to GenieRx in May of this year.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “Annual cancer cases are projected to rise considerably worldwide by 2050, according to a World Health Organization report on cancer published Wednesday. With its assessment, the United Nations body tempered optimism about improvements in cancer surveillance and treatment and warned that global health care inequities are driving further cases and deaths. 
    • “Around 20.6 million people were diagnosed with cancer in 2024, according to the findings. That number could reach 35 million a year by 2050.
    • “The new cases will disproportionately appear in lower-income countries with poorer access to cancer surveillance and treatment, according to the report.” * * *
    • “In the United States, the rate of new cases has generally been stable in recent years, according to the National Institutes of Health. The WHO report predicts that cancer rates will increase in all regions across the world, though the biggest increases are projected in Africa and the Eastern Mediterranean region.”
  • Health Day adds,
    • “More men die from cancer than women, and a new study suggests one potential reason why.
    • “Men are more likely than women to be diagnosed with advanced cancer that has spread to other parts of the body, researchers report in the July issue of the journal Cancer Epidemiology, Biomarkers & Prevention.
    • “That means their cancer is being detected too late, when it’s tougher to treat and more likely to be fatal, researchers said.
    • “We know that, overall, males are more likely than females to die from many types of cancer. We also know that cancer stage at diagnosis is a key predictor of cancer survival,” lead researcher Beth Maclin, a postdoctoral fellow at the National Cancer Institute in Bethesda, Maryland, said in a news release.” * * *
    • “My overall message is that everyone should go to the doctor regularly,” Maclin said. “Don’t delay seeing a doctor if you notice something has changed in your body.”
  • The AP relates,
    • “Nearly 1,000 people in Michigan have been diagnosed with a parasitic infection that can cause weeks of watery diarrhea, making it the largest such outbreak in state history and one of the nation’s largest in years.
    • “No deaths have been reported and the source of the cyclospora infections hasn’t been identified. Meanwhile, investigations into similar illnesses have been going on in 28 other states, including in Ohio, where people just across the Michigan border are also becoming sick.
    • “Michigan officials first announced the outbreak last week, when they were aware of more than 170 cases — all in the southeastern corner of the state — since June 22. Michigan usually identifies only about 50 cases each year.
    • “On Wednesday, the state reported the number had grown to 992, including about 40 hospitalizations. Just across the state line, Lucas County, Ohio, reported 306 cases as of Wednesday. Northwest Ohio has seen more than 500 cases.
    • “Cyclospora surges can be tricky to investigate, and food poisoning sources can be hard to establish. But “there is clearly a linked outbreak happening right now,” Dr. Natasha Bagdasarian, Michigan’s chief medical executive, told The Associated Press on Wednesday.”
  • MedPage Today tells us,
    • “Chronic kidney disease prevalence held steady at around 14.8% over the last decade, despite treatment advances.
    • “This translated to an estimated 36 million affected U.S. adults, based on national health survey data.
    • “The prevalence of diabetes-related chronic kidney disease increased during the period spanning 2013-2014 to 2021-2023.” * * *
    • “This means single-organ care is no longer enough, said [Sophie] Claudel [, MD]. Based on the data, a growing proportion of the population may be at risk for progressive cardiovascular-kidney-metabolic (CKM) syndrome.
  • Healio informs us,
    • “GLP-1s may prevent adverse outcomes in patients with peripheral artery disease and diabetes, according to data published in the Journal of the American Heart Association. 
    • “Researchers reported that GLP-1 receptor agonist use among patients with PAD and diabetes was associated with lower risk for mortality, hospitalization, revascularization and amputation compared with those prescribed metformin.
    • “Obesity and PAD, including chronic limb-threatening ischemia, are linked to increased inflammation, poor blood vessel function, insulin resistance, oxidative stress and faster hardening of the arteries,” Akiva Rosenzveig, MD, cardiology fellow at Cleveland Clinic, said in a press release. “These results indicate GLP-1 [receptor agonists] can help reduce inflammation, improve blood vessel function and manage blood sugar levels.”
  • Medscape adds,
    • “The FDA approved Zepbound (tirzepatide) in December 2024 for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in patients with obesityafter research showed that the medication improved outcomes in these patients.
    • “Sleep apnea is among the most common sleep disorders. It occurs when the airways relax and block breathing during sleep. Patients may repeatedly stop breathing, leading to disrupted sleep, snoring, and excessive sleepiness during the day.
    • “Now new research has shown that certain patients seem to benefit more than others from the medication. Patients with the most severe sleep apnea along with those who are younger and have less severe obesity experienced nearly twice the reduction in symptoms compared to those who are older and have more severe obesity.”
  • Fierce Pharma points out,
    • “In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.
    • “While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.
    • “The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.
    • “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.
    • “Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma.” 
  • BioPharma Dive lets us know,
    • “A nucleic acid-based medicine from AstraZeneca and Ionis Pharmaceuticals missed its main objective in a big study of people with a deadly heart condition in a major setback with notable ramifications for multiple other drugmakers. 
    • “In a pair of statements, the companies said that when compared to a placebo in people with transthyretin-mediated amyloid cardiomyopathy, or ATTR-CM, their drug, eplontersen, didn’t significantly reduce the risk of death or recurrent cardiovascular events after 140 weeks. Eplontersen had no treatment effect among participants already receiving a commonly used “stabilizer” medication. A 29% risk reduction was observed in people who weren’t getting those drugs, AstraZeneca and Ionis said.
    • “The companies didn’t provide additional study details, only noting that the drug was “well tolerated” and showed positive signs on multiple other secondary study measures. Those specifics will be presented at a medical meeting in August. “
  • and
    • “Roche said Thursday it’s discontinuing two Ionis-partnered drugs for Huntington’s disease after clinical setbacks, with one missing its main trial goal and the other suspended because of a safety worry.
    • “A Phase 2 test of the antisense oligonucleotide tominersen “did not meet its efficacy objective” in spite of having a significant impact on biological disease signs, Roche said in a letter to patient groups. Meanwhile, enrollees in a Phase 1 trial of a drug codenamed RG6496 won’t receive a second dose because animal safety testing revealed that it “cannot be given chronically with repeated doses,” Roche said.
    • “The Swiss pharmaceutical giant had once before suspended a late-stage trial of tominersen because it didn’t appear to be helping patients. Roche forged ahead with a hypothesis that younger and less-advanced patients might benefit, but now that pathway has hit a dead end.”
  • Per Genetic Engineering and BioTechnology News,
    • “A landmark Phase I/II clinical study led by researchers at Skåne University Hospital and Lund University has shown that transplanting stem-cell-derived dopamine progenitor cells into the brain is feasible. Eight patients with Parkinson’s disease (PD) received transplants of STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor product derived from human pluripotent stem cells. The three-year Phase I/II, open-label, multicenter, single-arm, dose-escalation study identified no serious side effects linked to the transplanted cells during the first year of follow‑up.
    • “The possibility of replacing dopamine neurons that are lost in Parkinson’s disease has been a long-standing goal in the field,” said Malin Parmar, professor of cellular neuroscience at Lund University, and lead of the STEM-PD program. “The findings represent an important milestone for regenerative medicine approaches in Parkinson’s disease and support continued clinical development of stem cell-based therapies.”
    • “Results from the study were reported by Parmar and colleagues in Nature Medicine. In their paper, titled “Human embryonic stem cell-derived dopaminergic cells for Parkinson’s disease: a Phase I/II open-label trial,” the team wrote, “In conclusion, particularly in the context of other recently published trials using human PS cell-derived dopaminergic cell therapies for PD, these findings further support the continued development of this therapeutic approach, including evaluation of the STEM-PD product in larger patient cohorts.”

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

  • Healthcare Dive reports,
    • “CVS’ insurance division Aetna has a finally gotten a handle on medical spending after a turbulent few years, according to the healthcare giant’s chief executive.
    • “We’ve got, I think, our arms around how to project and predict where healthcare costs are going, and making sure we’re pricing our products accordingly,” CVS CEO David Joyner said at an event hosted by the Economic Club in Washington, D.C., on Thursday.
    • “Joyner’s comments — which come about a month before CVS is scheduled to report second quarter results — are likely a welcome signal for investors that Aetna can continue recent progress on controlling spending.” * * *
    • “The biggest challenge for CVS isn’t managing members’ costs: It’s policy uncertainty out of Washington, Joyner said.
    • “I spend a lot of my time, both at the federal level and in the states, trying to help educate and also describe what are the real drivers of healthcare costs, and then making sure that we play an active role to help with members of Congress,” the CEO said.”
  • Fierce Healthcare relates,
    • “UnitedHealthcare is rolling out a new benefit option aimed at making it easier for employers to offer more personalized wellness programs.
    • “Called Lifestyle Spending Accounts (LSAs), the benefit allows employers to offer a stipend that members can put toward wellness solutions. The LSAs are integrated with UnitedHealth’s UHC Store, which is a digital storefront where members can purchase select health and wellness programs at a discount.
    • “The accounts exist alongside health savings accounts or flexible spending accounts, allowing individuals to purchase health and wellness generally not available under HSAs or FSAs, UnitedHealthcare said.”
  • Benefits Pro tells us,
    • “Both the levels and growth of health care spending from 2005 to 2023 were greatest among Americans with the highest incomes, according to a new report in Health Affairs.
    • “Among the lowest income quintile, spending grew more rapidly just after 2014 but declined from 2018 to 2023. By contrast, spending in the highest income quintile grew more rapidly in recent years. As a result, the difference in age and health status-adjusted spending between the highest and lowest income quintiles declined after implementation of the Affordable Care Act subsidies but increased more recently. The adjusted per capita spending difference in 2023 was more than $4,700.
    • “If spending continues its most recent trajectory, that difference will continue to grow,” the report said. “These spending patterns were driven largely by outpatient and prescription drug spending, which tend to be more discretionary than inpatient and emergency department spending. Prescription drug spending showed a particularly pronounced recent divergence for the top income quintile. Recent spending growth was most evident in the population younger than age 65, which has more variation in insurance coverage, affecting both service use and prices.”
  • Psychology Today lets us know,
    • “Mental health leave [under federal and state leave acts] has sharply increased in the U.S. since the pandemic.
    • “Women, especially caregivers, account for the majority of mental health leaves.
    • “Access to mental health leave highlights structural inequalities in the workplace.
    • “Early, ongoing treatment with an established provider can support the mental health leave process.”
  • Per Smart Brief,
    • “Healthcare AI’s next challenge isn’t adoption. It’s reliability
    • “Healthcare has reached a point where the challenge with AI is not adoption but ensuring it is accountable and dependable post-deployment, writes Sina Bari, vice president of healthcare and life sciences AI at iMerit.”
  • Per MedTech Dive,
    • “Stereotaxis said Thursday it finalized the acquisition of French surgical robotics company Robocath.
    • “Announced in April, the deal is valued at up to $45 million and brings together two robot developers focused on endovascular interventions, which are performed inside blood vessels.
    • “Combining the companies’ expertise will speed development of next-generation robotic technologies for electrophysiology, interventional cardiology and neurointerventions, the companies said.”
  • Per Fierce Pharma,
    • “Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. 
    • “Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. 
    • “If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam.
    • “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.”
    • “Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology.”

Midweek report

David Ermer–ACA, Agentic & Generative AI, CDC, CMS, Congress, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Per a Senate news release,
    • “On Wednesday, July 15, [beginning at 10 am ET], the U.S Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a confirmation hearing on the nomination of Sean Kaufman to be Assistant Secretary for Preparedness and Response for the U.S. Department of Health and Human Services and Erica Schwartz to be Director of the Centers for Disease Control and Prevention.”
  • The Wall Street Journal reports,
    • “Rates for many Affordable Care Act plans rose by double digits this year. Insurers want to do the same next year.
    • “Some of the biggest Obamacare companies are seeking hefty premium increases for 2027, often for the second year in a row. In Washington state, Centene is asking for a 28% hike, after boosting rates by 35% in 2026. Blue Cross and Blue Shield of Illinois wants 15%—on top of a 28% increase this year.
    • “It is a stunning jump” when you add both years together, said Cynthia Cox, senior vice president at KFF, a health-research nonprofit. At the request of The Wall Street Journal, KFF analyzed the rate requests for the largest ACA plans by enrollment in 15 states where insurers’ 2027 filings have already become public, as well as the District of Columbia.” * * *
    • “KFF calculated the median increase across 77 publicly available ACA rate filings for 2027: 14%. For 2026, the median final rise across all ACA plans was 20%.   
    • “Insurers’ 2027 ACA rates have to be reviewed by regulators, and the premiums finalized in late summer might be different from these early requests.”
  • Beckers Payer Issues reports,
    • “CMS has rescinded a decade-old “fast-track” review process for certain Medicaid Section 1115 demonstration waiver extensions as the agency prepares to implement new federal budget neutrality requirements that take effect in 2027.
    • “The July 7 informational bulletin formally withdraws 2015 guidance that allowed eligible states to use an expedited review process when renewing some Section 1115 demonstrations.
    • “CMS said the change is necessary because new statutory requirements will require the agency’s chief actuary to certify that Medicaid demonstrations will not increase federal spending before they can be approved, renewed or amended beginning Jan. 1, 2027.” * * *
    • “CMS previously notified state Medicaid directors that it intends to propose new budget neutrality policies and expects to issue additional implementation guidance. The agency said it remains committed to working with states to support Medicaid and CHIP innovation while complying with the new statutory requirements.”
  • Federal News Network relates,
    • “The Trump administration is looking to tweak the rules for federal employees’ paid administrative leave. Recently proposed regulations from the Office of Personnel Management would give agencies more leeway to use paid leave, including during workforce reduction efforts. During 2025, agencies used administrative leave to implement the deferred resignation program, choosing to paying thousands of employees for several months not to work, in exchange for them agreeing to quit their jobs.”
  • and
    • Federal News Network interviews Tammy Flanagan about early retirement for federal law enforcement officers.
      • [I]n law enforcement, typically, you’ve got to retire by the time you’re 57. And sometimes that’s hard because they really love that career for the most part, and that’s their identity. So leaving that early sometimes can be a tough transition, not only financially, but also emotionally.
  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services and the Centers for Medicare & Medicaid Services July 8 launched  a voluntary pledge that hospitals can sign related to their efforts on healthy food. Among other actions, the pledge asks that hospitals prioritize food options in alignment with the 2025-2030 Dietary Guidelines for Americans; ensure that inpatient meals meet individual nutritional needs; provide accessible nutrition education and resources to sustain healthy habits following discharge; and provide community-based nutrition programs to support healthier communities.” 

From the Food and Drug Administration front,

  • STAT News reports,
    • “The top contenders to lead the Food and Drug Administration have been sent to the White House for a final review and decision, according to a person familiar with the process.
    • “The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department.” * * *
    • “The advancement of the finalists suggests the highly anticipated decision is on the horizon, though the timing remains unclear.”
  • Politico discusses the FDA’s 2026 regulatory agenda which was released on July 3.

From the judicial front,

  • HealthExec reports,
    • “Once scheduled for the fall, the federal murder trial against the man accused of killing UnitedHealthcare CEO Brian Thompson will now begin in January, a judge determined last week.
    • “At the conclusion of a June 29 hearing, U.S. District Judge Margaret Garnett agreed with attorneys representing Luigi Mangione who argued the original date of Oct. 13 left little time to prepare a defense.
    • “A trial in New York on state charges of second-degree murder is set to begin first, with jury selection pegged for a Sept. 8 start date, followed by opening arguments on Oct. 13—the same day the federal trial was initially scheduled to begin. With it now pushed back, Mangione’s attorneys need only worry about the looming prospect their client could be spending the rest of his life in prison as a result of the first trial.”
  • Per a Justice Department news release
    • “The founder and former Chief Executive Officer (CEO) Ruthia He of Done Global Inc., a California-based digital mental health company, was sentenced today to six years in prison and a fine of $1 million for orchestrating a scheme that used her company’s technology platform, compensation structure, and clinical protocols to unlawfully distribute over 37 million pills of Adderall, defraud insurers of over $12 million, and obstruct the federal investigation that followed.”

From the public health and medical / Rx research front,

  • The Hill reports,
    • “As of Monday [July 6], the parasitic illness has spread to at least 18 states, with the most cases reported in Illinois, Michigan, New York and Texas.
    • “While exact numbers are unknown, the Michigan Department of Health and Human Services has reported 572 cases of cyclosporiasis as of July 4, and New York has reported more than 100. No exact numbers have been released for Illinois or Texas. Current figures are most likely an undercount, as most people who are sick don’t report it or go to a doctor unless it’s severe.
    • “Other states linked to the outbreak include Alaska, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia and Wisconsin.”
  • Health Day relates,
    • “Exercise can boost a smoker’s odds of successfully quitting, a new evidence review says.
    • “Smokers taking part in exercise programs were more likely to either quit or cut back on cigarettes, researchers reported recently in the Journal of Sport and Health Science.
    • “In fact, a single bout of exercise immediately reduces nicotine cravings for up to a half hour afterward, researchers found.
    • “Quitting smoking is one of the best things a person can do for their health, but it’s also one of the hardest,” lead investigator Ben Singh, a research fellow at Adelaide University in Australia, said in a news release.
    • “Many smokers want to quit, but the current approaches don’t work for everyone,” Singh said. “That’s why we need more strategies that people can incorporate into their daily lives at little or no cost.”
  • The New York Times discusses the medical problems created by parents refusing to protect their infants with an injection that resolves the Vitamin K deficiency with which all of us are born. It’s worth a read.
  • STAT News tells us,
    • “Could a lifesaving lung transplant strategy that contained the Covid-19 virus also save patients whose advanced lung cancer hasn’t spread? 
    • “That’s the question that inspired surgeons and oncologists at Northwestern Medicine to offer double lung transplants to patients who had run out of treatment options but whose late-stage cancer hadn’t left their lungs. People with late-stage lung cancer have not been transplant candidates before for two reasons: rates were high for cancer recurrence and low for survival.
    • “There are ethical considerations to weigh, too, when deciding how to allot donated organs.
    • “On Wednesday, the Northwestern team reported in JAMA that the 17 patients who received lung transplants after advanced but limited cancer fared better than 81 similar patients who continued standard immunotherapy, chemotherapy, or radiation treatments. Overall, the study followed 404 patients with end-stage pulmonary disease, including 98 with stage 4 lung cancer.
    • “After one year, through June 2025, all the lung cancer transplant patients had survived compared to 88% of patients transplanted without cancer. Among those 17 patients, by January 2026, there were four recurrences of cancer and two deaths unrelated to cancer — one from an infection and one from a blood clot. Among the 81 cancer patients getting standard care, 74 saw their cancers progress.”
  • Genetic Engineering and Biotechnology News informs us,
    • “It has long been known that brain gray matter plays a key role in multiple sclerosis (MS) disease progression and cognitive impairment, but because magnetic resonance imaging (MRI) has only been able to detect lesions in white matter, neither clinicians nor researchers have had a way to detect or monitor gray matter (cortical) lesions. And while many new drugs developed in the past decade can slow disease progression significantly, they primarily work on reducing white matter lesions.
    • “A University at Buffalo (UB)-led team now reports that it has found a way to use artificial intelligence to reveal these otherwise invisible cortical lesions by reviewing existing MRI scans. The researchers say the significance of finally being able to see what has been known as one of the most important indicators in MS disease progression cannot be overstated.”
  • Healio points out,
    • “Public health messaging had a longer-lasting impact on parents’ intent to vaccinate their children against HPV than AI chatbot interactions.
    • “Strategies to make both modalities more effective are needed.”
  • Per Fierce Healthcare,
    • “After thriving in the market for more than a decade as the only treatment for Dupuytren’s contracture and Peyronie’s disease, Keenova Therapeutics’ Xiaflex has excelled in a phase 3 trial that could set up the injectable biologic enzyme for approval in a third indication.
    • “The study of 436 patients with plantar fibromatosis achieved its primary endpoint, showing statistically significant and clinically meaningful reductions in pain versus placebo as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).” * * *
    • “Plantar fibromatosis, which is also known as Ledderhose disease, causes lumps composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. It can cause pain, swelling, and difficulty walking. Based on claims data and projections, Keenova estimates that 300,000 people will see a healthcare provider for plantar fibromatosis in 2028.
    • “There is no medicine on the market specifically for plantar fibromatosis. Patients can get relief through radiation therapy or corticosteroid injections, with surgical interventions generally reserved as a last resort.” 
  • The Wall Street Journal reports,
    • “Some patients are using GLP-1 drugs to treat eating disorders like bulimia and binge-eating disorder.
    • “No major medical organization has endorsed GLP-1s for eating disorders, and drugmakers Novo Nordisk and Eli Lilly say they are not approved for this.
    • “Experts say widespread adoption is unlikely soon due to limited scientific data.”
  • Per MedTech Dive,
    • “Penumbra said Tuesday it has started a clinical trial that could support wider use of mechanical thrombectomy in a subset of stroke patients.
    • “The real-world prospective study is assessing Penumbra’s RED reperfusion catheter portfolio in patients with M2 occlusions.
    • “Penumbra, which Boston Scientific has agreed to buy for $14.5 billion, is assessing whether its computer-assisted vacuum thrombectomy and modulated aspiration tools improve outcomes.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “A newly released audit of UnitedHealth’s home visits for Medicare seniors found little evidence to support accusations that the program, called HouseCalls, drums up extra patient diagnoses to inflate UnitedHealth’s reimbursement from the federal government.
    • “UnitedHealth argued that the results vindicate HouseCalls, which has faced scrutiny from regulators and lawmakers focused on combating profiteering in Medicare Advantage, Medicare’s privatized sister program.
    • “About 96.6% of diagnoses that UnitedHealth found during the home visits were backed up by patients’ health records, according to the audit released Tuesday from FTI Consulting, which used the same review process as the government.
    • “That leaves 3.4% of diagnoses unsupported by medical information — three times lower than the error rate found by the CMS in its most recent audit of data in the privatized Medicare program.
    • “UnitedHealth said it reviewed FTI’s findings and that the lion’s share of diagnoses unsupported by medical records were backed up by other information like paid claims.”
  • and
    • “Data from consumer wearables are valuable in clinical care, and many physicians are using the information in their practice — but widespread adoption is hindered by limited workflow integration and other barriers, according to a survey published Wednesday by the American Medical Association. 
    • “Eighty-six percent of U.S. physicians reported they at least sometimes reviewed data from their patients’ wearables, like information on heart physiology, oxygen and breathing, and sleep, according to the report, which also interviewed doctors from Canada, France, Germany, Spain and the U.K.
    • “But only 6% of doctors in the U.S. said wearable data was integrated into clinical workflows, like the ability to import information into electronic health records. “We have all this data that’s available, but it’s actually not actionable because we don’t have a way to get it into clinical workflow,” AMA CEO Dr. John Whyte said in an interview.”
  • Modern Healthcare relates,
    • “Health insurance companies and third-party vendors offer arrangements to mitigate the costs of cell and gene therapies to employers.
    • “More than three-quarters of employers see gene therapies as a major challenge, yet 35% lack financial protection, a survey found.
    • “The Food and Drug Administration has approved cell and gene therapies for conditions such as blood cancers and neurodegenerative diseases.”
  • MedCity News adds,
    • “In Oncology, the Cost Problem Goes Beyond Predictability.
    • “Healthcare does not lack the data needed to better understand oncology costs. What it does lack is a consistent way to connect clinical progression with financial impact in a time frame that aligns with strategic planning.”
  • Beckers Payer Issues tells us,
    • “Memorial Hermann Health System plans to shut down its commercial health insurance business.
    • “The wind-down affects the Houston-based system’s HMO, PPO, and self-funded products for employers. On its website, the system said it would be difficult to reach the scale needed to sustainably provide value to members moving forward. The closure notice does not include the system’s Medicare Advantage business.
    • “This decision was made following a careful and comprehensive assessment of system assets and resources, including an evaluation of existing opportunities and future challenges amid sustained pressures on health system-owned health plans,” the system wrote.
    • “Current coverage will remain in effect, and providers can continue treating members through each plan’s termination date, which will vary by employer group. Groups whose plan year is set to renew before Dec. 1 will have the option to enroll in one additional year of coverage before the full closure.”
  • and
    • “Josh Michelson started serving as executive vice president and chief strategy and innovation officer for The Cigna Group, according to a recent LinkedIn post.
    • “A Cigna website said Mr. Michelson is responsible for steering the company’s long-term strategic direction, corporate innovation and The Cigna Group Ventures, the company’s venture capital branch.
    • “He joined Cigna in 2020 and was most recently a senior vice president and chief strategy and transformation officer for the company.”
  • Beckers Health IT notes,
    • “[The major electronic health records company] Epic named four executives who will take on expanded responsibilities following President Sumit Rana’s departure, according to a statement from Founder and CEO Judy Faulkner shared with Becker’s.
    • “Ms. Faulkner said Seth Howard, Mark Lipsky, Erv Walter and Garrett Adams are among a small group of leaders who will be adding to their responsibilities as the company moves forward without Mr. Rana.
    • “The statement did not detail the additional responsibilities these individuals would be taking on.” * * *
    • “Mr. Rana’s departure leaves a notable gap at the top of the nation’s largest EHR vendor. He was widely viewed as a potential successor to Ms. Faulkner, who is 82.”
  • Per Cardiovascular Business,
    • “Novo Nordisk is now working with Vivani Medical, a California-based biopharmaceutical company, to evaluate the potential of a long-lasting semaglutide implant. This is a non-exclusive agreement between the two companies. 
    • “Novo Nordisk, one of the world’s largest pharmaceutical companies, sells semaglutide under the brand name Wegovy. Vivani is known for its drug implants, which are designed to help patients benefit from life-changing medications without ever needing to inject or ingest them. 
    • “The goal of this partnership is to reduce the risk of non-adherence and ensure patients taking semaglutide can receive the care their physicians have determined they need. The implant in question, currently known as NPM-139, is being developed to help patients with chronic weight management. It utilizes Vivani’s proprietary NanoPortal technology and could help patients receive the maximum benefits of treatment with just one or two treatments per year.
    • “Vivani is also preparing the launch of a new first-in-human clinical trial that would randomize certain patients to either undergo treatment with an NPM-139 implant or receive semaglutide injections.”
  • Per MedTech Dive,
    • “Resmed has agreed to sell its MatrixCare software business for $490 million to private equity firm Frazier Healthcare Partners. The deal is meant to sharpen Resmed’s focus on sleep and breathing health devices and connected, home-based care.
    • “Divesting MatrixCare enables Resmed to reallocate capital and resources toward higher-growth opportunities and expansion of its digital health ecosystem, the company said Tuesday.
    • “The cash transaction is expected to close in the first quarter of Resmed’s fiscal 2027, which ends in September.”

Tuesday report

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

Simplicity is a virtue

From Washington, DC,

  • Roll Call reports,
    • “The sweltering Fourth of July weekend is over, but for both parties in House and Senate leadership, the heat is still cranked up.
    • “Both chambers are likely to return next Monday to the same sweat-inducing tangle of legislative problems that left them stumped as they headed out of town at the end of June.
    • “Speaker Mike Johnson, R-La., is looking for a solution so “irresistible” that his fellow Republicans will have to accept it — but the numbers are working against him.
    • “For one thing, August is fast approaching, leaving just a couple weeks in Washington before lawmakers depart for an even longer summer break. And as Senate Majority Leader John Thune, R-S.D., has said all along, mathematical realities can’t be changed in the Senate, even when it comes to the White House-backed voter ID bill dubbed the SAVE America Act.”
  • Beckers Hospital Review relates,
    • “CMS is proposing to create a new payment pathway for algorithm-driven diagnostic software, including AI tools, as part of its 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center proposed rule, issued July 2. 
    • “The proposal marks CMS’ first attempt to build a standardized payment structure for what it calls “Software as a Medical Service” — clinical software that uses algorithms to analyze patient data and produce a diagnosis, risk score or treatment recommendation.”
  • and
    • “The planned July meeting for the U.S. Preventive Services Task Force has been postponed until late August, an HHS spokesperson told Becker’s.” * * *
    • “The HHS spokesperson said the July meeting was postponed due to an “unprecedented” number of nominations for task force membership, to allow more time for selection and onboarding of new members.”
  • Fierce Healthcare reports,
    • “The American Medical Association (AMA) updated maternity care coding Thursday, in what it says is the “most significant” move in decades to improve care delivery and data to advance maternal health.
    • “Beginning Jan. 1, 2027 (PDF), current procedural terminology (CPT) codes will reflect modern obstetric care, enable accurate and transparent reporting across the full pregnancy spectrum and create a data foundation for improved care throughout the entire patient journey.
    • ‘The update featured the deletion of 17 codes, the creation of six codes and the revision of six codes. It also includes new subsections, revised guidelines and relocation for some existing codes.
    • “Moreover, new CPT codes (PDF) will separately identify four phases of care: antepartum, labor management, delivery and postpartum.” * * *
    • “There is no expected impact on health plan benefits or an increase in cost-sharing, according to an AMA analysis using data from more than 650 physicians and certified nursing midwives.”
  • FEHBlog observation. We shall see.
  • KFF Health News explains how surprise Medicare Part D premiums can adversely affect Medicare Part D beneficiaries.

From the Food and Drug Administration front

  • Per a July 6, 2026, FDA announcement,
    • “The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of E. coli O145:H28 infections linked to frozen GreenWise brand-organic blueberries recalled by Frutas y Hortalizas del Sur S.A, of San Carlos, Chile.”
    • “Recalled frozen GreenWise-brand organic blueberries in 10-oz packages with printed lot code of 60401 and Best by Date of February 9, 2028.” * * *
    • “Recalled product was shipped to Publix retail stores throughout 8 states including Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia. Blueberries may have been distributed to other retailers, and FDA will update this advisory as more information becomes available.” 
  • Cardiovascular Business reports,
    • “Medtronic is recalling certain lots of the delivery catheter system for its Harmony Transcatheter Pulmonary Valve (TPV) System due to a significant safety risk. The U.S. Food and Drug Administration (FDA) has ruled this as a Class I recall, which means using the device could cause “serious adverse health consequences or death.”
    • “Medtronic initiated the recall after identifying an issue with the delivery system that could lead to distal tip detachment during implant procedures. More than 1,800 devices are included in this Class I recall.
    • ‘The Harmony TPV system is used to treat a native or surgically repaired right ventricular outflow tract (RVOT) in patients with severe pulmonary regurgitation. It has received FDA approval in addition to CE mark approval. Click here to read about a recent analysis of the device’s safety and effectiveness.”
  • Fierce Pharma relates,
    • “When Vera Therapeutics in-licensed atacicept from Merck KGaA about six years ago, patients with IgA nephropathy (IgAN) had no FDA-approved treatment options. Today, the dual-target drug has crossed the regulatory finish line but is entering a vastly different landscape as the sixth drug approved for the rare kidney disease.
    • “Atacicept, a recombinant fusion protein to be marketed under the brand name Trutakna, is now the first drug in the U.S. that inhibits both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), two cytokines involved in B-cell survival and the production of autoantibodies associated with IgAN.” 

From the judicial front,

  • Per a June 25, 2026, Justice Department news release,
    • “Julianna C. Lung pleaded guilty in federal court today to health care fraud, admitting she marketed and sold hearing protection devices to United States Border Patrol agents, other federal employees, and their family members, then falsely billed insurance providers for what she claimed were medically-necessary hearing aids.
    • “According to her plea agreement, Lung submitted approximately 385 fraudulent claims to health insurance plans participating in the Federal Employees Health Benefits (FEHB) program. The claims falsely represented that beneficiaries suffered from hearing loss or tinnitus that required treatment.
    • “In reality, Lung told customers the devices were intended to protect their hearing—not treat a medical condition—and assured them their insurance would cover the cost for that purpose.
    • “As a result of the scheme, FEHB plans paid approximately $2,500 per device, totaling about $962,500 in fraudulent reimbursements.”

From the public health and medical / Rx research front,

  • Dr. Drew Altman, writing in KFF Health News, tells us,
    • Many of us in health care are deeply concerned about misinformation (and declining trust), so it seems important to underscore that while the American people may not always be as science-based as we might like them to be, they may also not be as anti-science as you may think they are—only a sliver of the public are hard-core refusniks who believe the lies, myths, misinformation or misbeliefs about vaccines. Occasionally, a lie breaks through when it’s amplified by someone influential and by the media. For example, 41% of the American people believed there were death panels in the ACA, but that’s the exception, not the norm.
    • In our most recent Tracking Poll on Health Information and Trust, we tested out who believed and didn’t believe each of four vaccine-related myths: “Getting the measles vaccine is more dangerous than becoming infected with measles;” “mRNA vaccines can change your DNA;” “measles, mumps, and rubella vaccines, also known as the MMR vaccines, have been proven to cause autism in children;” and, “more people have died from the COVID-19 vaccines than have died from the COVID-19 virus.” Here’s what stood out to me from these findings:
      The share of the public who believe these four myths is very small. Between 3% and 8% of the adult population believe these different vaccine myths are “definitely true.” By any standard, that’s a small, even tiny share of the overall adult population (for context, about a quarter of adults say they are MAGA). These are likely most of the folks you see in the spikes in social media engagement we sometimes observe when influencers or leaders like Secretary Kennedy amplify vaccine or
      other myths. 
    • Looked at another way, the hard-core group is even smaller: Just 1.3% believe all four false claims about vaccines are “definitely true.” 
    • By contrast, between 31% and 44% of the public think these claims are basically nonsense, meaning the share who don’t believe these things at all outnumber those who definitely do by almost 5-to-1 or more. That’s hardly the impression you get when you read reports about social media posts and views with characterizations like “engagement spiked” or “views tripled.” It’s important to track social media engagement to know how misinformation is spreading and who is spreading it, but it doesn’t give us a real picture of reach or impact. How many people believe it? How strongly? Who are they? Where did they get their information? Who do they trust and not trust when it comes to health information? That’s why we do our information and trust surveys. 
    • As I have written before and we have widely reported, most people are floundering around in a muddled middle uncertain what to believe. Take, for example, the slam dunk falsehood that “more people have died from the COVID-19 vaccines than from COVID-19 itself.” As you can see in the chart below, 53% of the American people are not certain about the answer to that question, with 34% saying that’s “probably false” and 19% “probably true,” Estimates are that the vaccine saved 2.5 million lives, and many more years of life. 
  • The Washington Post reports,
    • “The number of people injecting themselves with or taking an oral version of the new class of weight-loss drugs continues to rise dramatically.
    • “A Gallup poll released Tuesday based on a web survey of 5,065 U.S. adults says that 15 percent of U.S. adults reported using GLP-1 medications to lose weight at some point, while 11 percent say they currently are taking them.
    • “That’s up from a Gallup poll in 2024 that found 6 percent had ever taken them, and 3 percent were currently on the therapy.
    • “At the same time, respondents’ self-reported obesity rates have dipped, and diabetes rates have flattened. “The growing popularity of GLP-1 medications continues to point to broader health benefits for American adults as obesity levels curtail and the diabetes rate levels off after years of increases,” Gallup said.”
  • Beckers Payer Issues adds,
    • “The share of employers covering GLP-1s for both diabetes and weight loss has held steady at 36% year over year, according to a survey from the International Foundation of Employee Benefit Plans.
    • “The survey was conducted June 2 to June 12. The foundation represents more than 31,000 multiemployer, corporate and public sector members representing over 25 million lives.”
  • Radiology Business tells us,
    • “Experts are calling for greater integration of breast and lung cancer screening programs to help bolster monitoring for both diseases. 
    • “Researchers with Thomas Jefferson University, Philadelphia, made the case in a new analysis published July 3 by the Journal of the American College of Radiology. They noted that, despite the proven lifesaving benefits of mammography, completion rates remain as low as 55%, with worse screening adherence among socioeconomically disadvantaged patient populations. 
    • “Women eligible for lung cancer screening represent a unique population, they note, with elevated cancer risk and “substantial healthcare needs.” Previous studies have explored lung cancer screening among women already receiving mammography, but less is known about whether those actively engaged in LCS programs are up to date on their breast exams. 
    • “This represents an important gap in the literature because dual BCS/LCS-eligible women can be more efficiently identified from an [lung cancer screening] cohort than from a [breast cancer screening] cohort,” lead author Meghan Maceyko, MD, with the Department of Surgery at Thomas Jefferson, and colleagues wrote Friday. “Additionally, LCS participants may have access to highly structured LCS navigation pathways to facilitate BCS completion.”
  • The American Journal of Managed Care informs us,
    • “Adults with diabetes treated with insulin who were prescribed continuous glucose monitoring (CGM) by their primary care clinician were associated with meaningful and durable improvements in hemoglobin A1c (HbA1C), along with fewer hospitalizations and emergency department (ED) visits, according to a cohort study published in JAMA Network Open.”
      .
  • MedPage Today points out,
    • “Influenza vaccine effectiveness against death among U.S. kids and teens averaged 80% in recent years.
    • “Vaccine effectiveness against death was 77% among kids with underlying medical conditions and 87% among those without.
    • “The findings come against a backdrop of declining influenza vaccine uptake since 2021.”
  • and
    • “Roughly 22 high school students die each week from a fentanyl overdose.
    • “In a nationally representative survey study, less than half of 8th graders surveyed attributed great risk to experimental use of fentanyl.
    • “The study’s findings are a “call to action” to better educate children and teens about the synthetic opioid’s risks, a researcher said.”
  • Per Health Day,
    • “Artificial sweeteners may affect metabolism.
    • “Artificial and low-calorie sweeteners have been linked to higher fasting insulin, higher HbA1c and reduced insulin sensitivity.
    • “Alterations to the gut microbiome may help explain the observed metabolic changes.”
  • Cardiovascular Business notes,
    • “A polypill containing three different medications is associated with significant benefits for select heart failure patients, according to new findings published in Nature Medicine.[1]
    • “For the POLY-HF randomized trial, researchers explored data from 212 heart failure patients treated at two U.S. healthcare facilities. The median age was 54 years old, and 78% of patients were men. Nearly seven in 10 patients were either uninsured, or faced other barriers that can make it harder to receive optimal medical therapy.” * * *
    • “The study’s primary outcome, change in left ventricular ejection fraction after six months, was 3.3% higher for patients taking the polypill than it was for patients taking each medication separately. In addition, patients taking the polypill had a 60% lower rate of heart failure hospitalizations or ED visits.
    • “Adherence, evaluated by studying each participant’s blood for metoprolol and spironolactone, was also higher for patients taking the polypill than it was for patients taking each medication separately.”
  • Per STAT News,
    • “Compass Pathways said its investigational psilocybin treatment had lasting benefits on patients with severe depression out to six months.
    • “The biotech previously reported that 39% of patients who took two high doses in a Phase 3 trial achieved what Compass called a “clinically meaningful reduction” on a depression rating scale after six weeks. Today, it said that on average, those participants maintained the benefit through at least six months.
    • “In the trial, participants who didn’t achieve remission in the first six weeks were eligible to then get an additional dose. Compass said this morning that 28% of participants who had achieved a clinically meaningful response but not remission at six weeks did later go into remission after the additional dose. * * *
    • “Compass’ treatment is one of three psychedelic compounds the FDA has selected to review on an accelerated basis. It’s possible the drug could be approved as soon as this year.”

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

  • STAT New reports,
    • “It has never been more difficult for employers to offer health insurance for their workers. That’s especially true for America’s small businesses, the backbones of entire communities. More and more, they’re giving up entirely.
    • “America’s employer-based health insurance system — the dominant form of coverage for people younger than 65 — is crumbling. The percentage of working-age adults who get their health coverage from a job has declined from 67% in 1998 to about 60%. It’s also more expensive than ever.”
  • FEHBlog observation — To lower premiums, uncouple the employer market from the Affordable Care Act.
  • Modern Healthcare reports,
    • “Care navigators are helping health systems reduce unnecessary admissions and save money as chronically ill older adults and uninsured patients flood emergency departments. 
    • “Care navigators are typically nurses embedded in emergency departments who connect patients to less costly outpatient services to avoid hospitalizations. Providers, including St. Louis-based BJC Health System and Chicago-based Northwestern Medicine, have been growing care navigator programs.”
  • Healthcare Dive relates,
    • “Ascension has agreed to snap up a regional health system in a deal worth almost $1 billion as the Catholic nonprofit giant continues to beef up its portfolio.
    • “On Monday, Franklin, Tenn.-based Williamson Health announced it plans to sell to Ascension through the company’s Tennessee business Ascension Saint Thomas, after Williamson’s board voted unanimously in support of the change of ownership.
    • “The proposed transaction is still subject to approval by the Williamson County Board of Commissioners and other regulators. If the deal advances, the companies expect it to be finalized in 2027 or 2028.”
  • Beckers Hospital Review tells us,
    • “Jupiter (Fla.) Medical Center, an independent, nonprofit health system, broke ground June 24 on its second hospital, the “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir.”
    • “The 53,000-square-foot facility will comprise 29 inpatient beds, four operating rooms, 24-hour emergency services, imaging services and a diagnostic laboratory, according to a news release. 
    • “Jupiter Medical Center Neighborhood Hospital at The Health Park at Avenir will be adjacent to a 47,000-square-foot, three-story medical office building for Jupiter Medical Center physicians. The building will feature cardiology, concierge medicine, gastroenterology, general surgery, primary care, pulmonary and orthopedics.
    • ‘Both the hospital and medical office building are expected to open in early 2028.” 
  • Fierce Healthcare informs us,
    • “Handspring Health offers a virtual mental health clinic for youth and families, purpose-built around evidence-based care and ongoing training and support for clinicians.
    • “The startup, which launched four years ago, picked up $19 million in series B funding to grow its clinician workforce, expand value-based care partnerships with payers and broaden its geographic reach.”
  • Fierce Pharma lets us know how “biosimilar experts size up US hurdles, opportunities ahead.”
  • Beckers Payers Issues explains “How 4 health plans are innovating with specialty pharmacy.”
  • MedCity News offers “The AI Playbook for Health Plans: 5 Steps for Leaders Who Don’t Know Where to Start.”
    • “It starts with a simple mindset shift, realizing that a successful AI journey begins with identifying a business problem, not with technology. The plans that make real progress embrace this mindset first then follow these five steps.” 

Cybersecurity Saturday

David Ermer–Agentic & Generative AI, Cybersecurity–

From the Project Glasswing front,

  • Cybersecurity Dive reports,
    • “Anthropic on Wednesday [July 1, 2026] unfroze access to its advanced Fable and Mythos AI models after the Trump administration lifted an export-control ban.
    • The return of the two models — with Fable 5 available for general use and the more powerful Mythos 5 limited to a coalition of trusted partners, as it was prior to the ban — represents significant progress in ongoing talks between President Donald Trump’s administration and AI firms over the responsible deployment of frontier AI models, an issue the U.S. government and the tech industry have sparred over in recent months.
    • “In a Tuesday statement announcing a resolution to one of the AI race’s most intense clashes, Anthropic insisted that its models had always been safe and that the government had blown the situation out of proportion — suggesting that tense conversations still lie ahead about the balance between offering advanced capabilities to defenders and keeping them out of the hands of U.S. adversaries.”
  • Bleeping Computer adds,
    • “Anthropic says Claude Fable 5 won’t be accessible via Claude subscriptions after July 7, but it’s not a permanent change, and the company expects the model to return outside the usage-based plan soon.
    • “Fable 5 was recently restored after the US government lifted export controls on Anthropic’s most powerful models, Fable 5 and Mythos 5.
    • “As part of the redeployment, Anthropic said Fable 5 would be available globally on Claude.ai, Claude Code, Claude Cowork, and the Claude Platform.”
  • and
    • “Claude Fable, the company’s most powerful model, is now available to all users, but early impressions are disappointing, as it appears to be nowhere near the original release.” * * *
    • “[T]he real gut punch is the degraded performance, or as famously used in the AI community, the “nerfed” performance.
    • “On Reddit, users are reporting that the restored Fable 5 feels weaker, or is simply being routed through stricter safety systems more often than before.
    • “The new guardrails are kicking in on way too many tasks and falling back to Opus 4.8,” one user wrote in a Reddit post. “This is not the model that got banned.”
    • “The problem is not just limited to Claude desktop, as Claude Code is also struggling with similar issues.”
  • Observer interviews CrowdStrike president Michael Sentonas who “discusses Anthropic’s Claude Mythos and how A.I. could speed up vulnerability discovery and exploitation.”

From the cybersecurity policy and law enforcement front,

  • Cyberscoop reports,
    • “The Department of Homeland Security is bringing back a key cybersecurity information sharing effort with critical infrastructure, more than a year after the Trump administration shuttered an existing nerve center between government and private sector.
    • “The Alliance of National Councils for Homeland Operational Resilience – Critical Infrastructure program, first reported by CyberScoop in January, is meant to replace the function of the Critical Infrastructure Partnership Advisory Council.
    • “CIPAC was a federal advisory body that allowed agencies like the FBI, the Cybersecurity and Infrastructure Security Agency and the intelligence community to interact with key owners and operators of water, power, internet and telecommunications to coordinate on cyberattacks and digital vulnerabilities. ANCHOR will fulfill a similar role.
    • “ANCHOR-CI will provide forums through which cybersecurity, law enforcement, intelligence, national security, and other government representatives at the federal, state, local, tribal, and territorial levels may engage representatives of private sector entities and critical infrastructure owners and operators in reviewing the current threat environment, discussing potential vulnerabilities, and forming recommendations on securing a more resilient critical infrastructure and cyberspace,” DHS wrote in a federal register notice set to publish July 1.
    • “ANCHOR-CI will be managed by CISA, which will appoint members to the council from industry, trade associations, state and local governments and other sources.
    • “The body will consist of four types of different councils: one focused on federally designated critical infrastructure sectors, cross-sector councils to deal with emerging threats like cyber attacks or zero-day vulnerabilities, critical infrastructure industry councils and regional coordinating councils.”
  • and
    • “Trump administration budget chief Russell Vought told lawmakers Tuesday that he’s willing to work with Department of Homeland Security Secretary Markwayne Mullin on re-staffing up the Cybersecurity and Infrastructure Security Agency, following deep personnel cuts and further proposed reductions in the fiscal 2027 budget blueprint.
    • “Mullin said last week at a House Appropriations Subcommittee on Homeland Security hearing that he would like to hire 600 more people at CISA, similar to remarks he made earlier this month at another House hearing. President Donald Trump has cut or lost more than 1,000 from an agency that stood around 3,400-strong at the end of the Biden administration — cuts criticized by lawmakers in both parties.”
  • Federal News Network relates,
    • “The National Institute of Standards and Technology expects to advance high profile standards work around a “Cyber AI Profile” and securing artificial intelligence agents this summer, amid a flurry of federal activity aimed at addressing both the risks and opportunities for AI and cybersecurity.
    • “NIST’s National Cybersecurity Center of Excellence (NCCoE) is now running six distinct projects focused on the intersection of AI and cyber. But Cherilyn Pascoe, director of the NCCoE, said AI is popping up across the center’s work, which focuses on practical guidance to advance secure technologies in collaboration with government agencies, industry and academia.
    • “I think AI is going to be part, if not a leading part, of every project going forward at the center,” Pascoe said in an interview. “It is becoming so foundational to cybersecurity.”
    • “Recent advancements in AI models like Anthropic’s Claude Mythos have shown the ability to quickly find software vulnerabilities and create cyber exploits much faster than humans.”
  • Security Week tells us,
    • “Google, the FBI, and other organizations coordinated in a joint effort to dismantle NetNut, a massive residential proxy network.
    • “Also known as Popa, NetNut is believed to consist of more than 2 million Android devices such as smart TVs and streaming boxes, that have been infected through trojanized applications and malware such as Badbox 2.0.
    • ‘The network’s operator, linked to the publicly-traded Israeli firm Alarum Technologies Ltd, rented the residential proxies to various threat actors, including cybercriminal and espionage groups.
    • “In a single week in June, Google observed 316 distinct threat clusters using NetNut to hide their locations in password-spray attacks and to access victim environments.
    • “We believe our coordinated actions have caused significant degradation to NetNut’s proxy network and its business operations, reducing the available pool of devices for the proxy operator by millions,” Google said.
    • “As part of the operation, the internet giant disabled Google accounts and associated services used for command-and-control (C&C), dismantling the botnet’s backend infrastructure.”
  • Cyberscoop informs us,
    • “19-year-old alleged member of the Scattered Spider extortion crew was extradited to the United States last week and remains in federal custody awaiting several cybercrime charges, the Justice Department said Wednesday. 
    • “Peter Stokes, a dual citizen of the United States and Estonia, was allegedly involved in Scattered Spider since it formed in 2022 and boasted on social media about the luxurious globetrotting life he enjoyed while he was still a child. 
    • “The cybercrime ring of young, native English-speaking people has infiltrated more than 100 businesses since 2022, and extorted more than $100 million from its victims around the world, officials said.” 

From the cybersecurity breaches and vulnerabilities front,

  • HIPAA Journal reports,
    • “Verizon Business has released the findings from its inaugural Breach Impact Study, which focuses on the financial impact of data breaches. The BIS report is from the same authoring team as the Verizon Data Breach Investigations Report and was produced in partnership with CyberAcuView. The report is based on an analysis of around 70,000 U.S. cyber insurance claims, including 38,000 claims where the policies paid out. The data spans from January 2019 to October 2025.
    • “In contrast to many data breach cost reports, the report is based on median claim amounts rather than averages, which are susceptible to skewing. In 2019, the median financial impact was around $60,000, rising by 80% to $110,000 in 2025, with data breach costs outpacing inflation, which was around 23% over the period of the study. More than half of paid-out claims exceeded $83,000, with 10% having an impact of $920,000 or more. The most extreme 2.5% of cases exceeded $5 million in losses.
    • “The report shows that data breach costs almost doubled between 2019 and 2025, with business interruption the single largest loss driver, followed by loss to threat actor and response and recovery.”
  • MedTech Dive relates,
    • “Medtronic has begun to notify people who may have been affected by a cyberattack that was disclosed more than two months ago.
    • “Medtronic provided the update in a statement posted to its website on Monday [June 29, 2026]. At this time, Medtronic has no evidence the data that was accessed has been publicly posted or exposed to the internet, according to the statement.
    • “The company is providing 24 months of complimentary credit monitoring, dark web monitoring and identity theft restoration services. It is also setting up a dedicated call center to address questions for those affected.”
  • Bleeping Computer tells us,
    • “The Department of Homeland Security is investigating a cyberattack that compromised the Homeland Security Information Network (HSIN), a sensitive information-sharing platform used by federal, state, local, and private-sector partners.
    • “The intrusion, first reported by Nextgov, was carried out by an unknown threat actor in recent weeks and is believed to have occurred sometime between late May and early June, according to two people familiar with the matter who spoke on the condition of anonymity.
    • “DHS is currently investigating the attack and has reportedly not attributed it to any specific threat actor or foreign governments. Whether any documents were stolen from the system also remains unclear.”
  • Cyberscoop informs us,
    • “Toolkits to wage phishing campaigns are a now-venerable instrument for cybercriminals, but researchers recently turned up details on something like a full-fledged “business email compromise-as-a-service” platform.
    • “Cisco Talos said Wednesday that it had found an operator panel dubbed ARToken, which shares infrastructure and other things in common with, and as an affiliate to, the EvilTokens phishing-as-a-service operation built to bypass multi-factor authentication and compromise Microsoft 365 accounts. EvilTokens has reportedly seen a dramatic increase in its phishing attacks — by 1,380% early this year compared to the same period last year — with an assist from artificial intelligence integration.
    • “ARToken is notable, though, for the capabilities that go beyond what’s been made public about EvilTokens so far by companies like Sekoia and Microsoft itself, such as inbox rule manipulation and shared access links.
    • “These features indicate the platform is more mature than a simple device code phishing kit — it is a complete BEC operations environment,” wrote Michael Kelley, security research engineer at Cisco Talos, in a blog post, referring to business email compromise scams that involve sending fake emails to solicit fraudulent payments.”
  • and
    • “Citrix published a security bulletin Tuesday [June 30] disclosing six vulnerabilities in NetScaler ADC and NetScaler Gateway appliances, including a high-severity memory disclosure flaw that researchers say belongs to a vulnerability class first identified in the 2023 incident known as CitrixBleed.
    • “The company rated the overall bulletin severity as high and assigned CVSS scores ranging from 6.9 to 8.8 across the six CVEs. Citrix said customers should install the updated builds and, in one case, manually adjust a configuration parameter even after patching.
    • “The most closely scrutinized of the vulnerabilities, CVE-2026-8451, was discovered by researchers at watchTowr, a cybersecurity firm that has published several prior analyses of issues in NetScaler products. According to a technical writeup the firm released alongside Tuesday’s disclosure, the vulnerability stems from how NetScaler parses SAML authentication requests when an appliance is configured as a SAML identity provider, a deployment mode commonly used for single sign-on.”
  • CISA added two known exploited exploits (KVE) to its catalog this week.
  • Bleeping Computer adds,
    • “CISA confirmed on Monday that ransomware gangs have begun exploiting a high-severity Microsoft Defender privilege escalation vulnerability that has previously been abused in zero-day attacks.
    • “Dubbed BlueHammer, the security flaw (CVE-2026-33825) was leaked by a security researcher known as “Nightmare Eclipse” in early April, together with proof-of-concept exploit code, in protest at how the Microsoft Security Response Center (MSRC) handles the disclosure process.
    • “Insufficient granularity of access control in Microsoft Defender allows an authorized attacker to elevate privileges locally,” Microsoft explains in a security advisory.”
  • Dark Reading notes,
    • “NIST has reduced the number of CVEs receiving enrichment in the National Vulnerability Database since April due to a growing backlog, impacting the data available to security teams.
    • “Research from Volerion found that, between April 15 and June 15, only 6,759 out of 13,441 non-rejected CVEs published to the NVD received NIST enrichment, causing coverage gaps, delayed analysis, and reliance on inconsistent CVSS scores provided by over 500 CVE Numbering Authorities (CNAs).
    • “Volerion’s analysis identified issues with timeliness, enrichment quality, and scoring discrepancies—especially in critical metrics such as attack complexity—potentially causing organizations to misjudge vulnerability severity and prioritize incorrectly.
    • “The report urges organizations not to rely solely on NIST or CNA CVSS scores for risk assessment, recommending the use of diverse metrics and independent analysis for more accurate prioritization.”
  • Security Week points out,
    • “Cisco confirmed that a recently patched vulnerability in its Unified Communications Manager (Unified CM) and Unified Communications Manager Session Management Edition (Unified CM SME) has been exploited in the wild.
    • “Tracked as CVE-2026-20230 (CVSS score of 8.6), the security defect is described as the improper validation of specific HTTP requests, which could allow attackers to mount SSRF attacks.
    • “Successful exploitation of the bug could lead to arbitrary files being dropped to the underlying operating system, which could then be used to gain root access.
    • “Only appliances with the WebDialer service enabled are vulnerable, Cisco says. The service is disabled by default.”
  • Cybersecurity Dive adds,
    • “Researchers say a critical vulnerability in Oracle E-Business Suite is facing exploitation attempts by a threat actor. 
    • “The vulnerability, tracked as CVE-2026-46817, is a flaw in the Oracle Payments, and has a severity score of 9.8. 
    • “If successfully exploited, an unauthenticated attacker with network access via HTTP would be able to compromise the product. 
    • “Researchers at Defused observed a hacker exploiting the flaw on its Oracle E-Business honeypots, according to a post on X. The activity was observed on June 27 from a French IP address, but researchers said the threat actor was using a VPN. 
    • “There has been no prior known exploitation activity or any release of a proof of concept, researchers said.” * * *
    • “Oracle previously addressed the vulnerability as part of a larger series of security patch updates in May.”

From the ransomware front,

  • Dark Reading reports,
    • The initial access broker (IAB) operation behind the credential-harvesting FortiBleed campaign is working in concert with ransomware actors, indicating the victims of the massive operation are now facing an even greater threat.
    • Research published by SOCRadar this week connects FortiBleed actors with two ransomware-as-a-service (RaaS) gangs, Inc Ransom and Lynx. SOCRadar researchers discovered an operator behind the campaign’s infrastructure that was actively logged into the ransom negotiation panels for both groups, and “engaging directly with ransom demands.”
    • “Finding a single operator working both panels, using infrastructure traceable back to FortiBleed, is the clearest evidence yet that FortiGate credentials harvested through this campaign are being handed off, or used directly, for ransomware deployment,” according to the SOCRadar blog post. 
    • “The connection to ransomware gangs marks the latest development in this saga. The attacks against insecure Fortinet FortiGate firewalls were initially discovered last month by security consultant Volodymyr “Bob” Diachenko. SOCRadar then later found that the attacks were part of a global campaign it dubbed “FortiBleed,” which had compromised thousands of devices and used a Golang-based sniffer to turn firewalls into credential stealers.”
  • and
    • “An emerging ransomware campaign is targeting small businesses across multiple regions with fake Interpol notices designed to trick victims into downloading malware disguised as evidence of alleged criminal activity.
    • “The campaign has so far has targeted businesses in multiple sectors, including pharmaceuticals, food, agriculture, technology, media, and legal services in the US, Europe, Asia, and the Middle East.
    • “Besides its focus on small businesses, the campaign is notable because it highlights how attackers no longer need sophisticated ransomware or the resources of a major cybercrime operation to launch disruptive attacks, Bitdefender said in a report this week. “Even relatively simple malware can become a serious threat when paired with convincing social engineering,” Bitdefender security analyst Alina Bizga wrote.”
  • The Hacker News relates,
    • “Security firm Sysdig says it has found what it believes is the first ransomware attack run from start to finish by an AI agent.
    • “Its Threat Research Team calls the operator JADEPUFFER and says a large language model handled the whole job: breaking in, stealing credentials, moving deeper into the network, then encrypting and wiping a company’s production database.
    • “Ransomware has always needed a skilled person somewhere in the loop, either at the keyboard or writing the script the malware follows. If a model can chain those steps on its own, the skill needed to run an attack drops to whatever it costs to rent an AI agent.”
    • “The way in was an old, already-patched bug. JADEPUFFER exploited CVE-2025-3248, a missing-authentication flaw in Langflow, an open-source tool for building AI apps and agent workflows. The flaw lets anyone who can reach the server run their own Python code on it, no login needed.” * * *
    • “The fixes are familiar. Patch Langflow and never expose its code-running endpoints to the internet. Do not run AI tools with cloud keys and provider credentials sitting in their environment; keep secrets in a proper manager, away from anything the web can reach.
    • “Harden Nacos: change the default signing key, keep it off the public internet, and never let it connect to its database as root. Never expose a database’s admin account to the internet, and lock down outbound traffic so a hacked server cannot phone home.”
  • Cyberscoop explains,
    • “How ransomware syndicates weaponize corporate-style organization
      • “From outsourced labor to tiered pricing models, an inside look at how today’s top ransomware threats operate less like rogue hackers and more like Fortune 500 companies.”
  • Cybersecurity Dive informs us,
    • “A massive credential-harvesting campaign, dubbed FortiBleed, is linked to two ransomware-as-a-service operations, tracked as INC ransom and Lynx, according to a blog post Wednesday [July 2, 2026] by cybersecurity firm SOCRadar. 
    • An operator with access to FortiBleed infrastructure was found to be logged into negotiation panels for INC as well as Lynx, researchers said. 
    • In certain cases, the attacks may have involved exploitation of a vulnerability in a content collaboration platform called Nextcloud. The analysis is still ongoing, so a public advisory or common vulnerabilities and exposures number has not yet been assigned. 
    • “The Nextcloud issue appears to have been used as part of the attackers’ broader operational workflow, likely for expansion or infrastructure access after initial compromise,” Ensar Seker, CISO at SOCRadar, told Cybersecurity Dive.
    • “Not all cases involved Nextcloud, nor was compromise fully dependent on exploitation of the zero day.” 

From the cybersecurity business and defenses front,

  • The Wall Street Journal reports,
    • “Chinese artificial-intelligence systems have matched the performance of Anthropic’s powerful model Mythos in some cybersecurity scenarios, a development poised to reset the global tech race and pressure the White House in its overhaul of U.S. AI policy.
    • “Security researchers said that a new AI model, released this month by China’s Zhipu AI, also known as Z.ai, can match the latest U.S. models when it comes to finding security bugs, although it still lags behind Anthropic’s and OpenAI’s products in other tasks.
    • “Overall, the capability gap between top U.S. models and those built by Chinese companies has narrowed significantly, and use of Chinese AI systems has surged as businesses seek to rein in runaway costs. A host of companies, including Microsoft, are weighing how they can offer Chinese models on their platforms, a development that is set to alter the balance of power among tech companies.
    • “China is making sure that the gap becomes smaller and smaller over time,” said Lior Div, chief executive officer of the cybersecurity company 7AI.”
  • Dark Reading relates,
    • “Red Hat and its parent IBM have committed an eye-popping $5 billion to Project Lightwell, a new subscription-based patching service for enterprises running business-critical systems that can’t risk the disruption of updating open-source software in production. It is the largest known commitment specifically targeting open-source software supply chain security — dwarfed only by Google’s broader $10 billion cybersecurity pledge in 2021, which also covered zero-trust and workforce training.”
  • and
    • “Apple is changing its approach to security patching, in response to the growing threat of accelerated artificial intelligence (AI) attacks.
    • “The company has historically saved big, bundled sets of bug fixes for new versions of its operating system (OS). That’s set to change. The company released a variety of security updates June 29 for iPhones, iPads, Macbooks, and the Safari browser, untethered to any major version releases. It’s hardly the first time it’s released security updates out-of-band, but the motivation was different this time. According to Reuters, the company said “it was adapting to the reality that, given the ability of artificial intelligence to speed the development of malicious hacking tools, it ⁠needed to reduce the time between when updates were first made public and when they were put into customers’ hands.”
  • Tech Target discusses “The agentic AI ‘lethal trifecta’: What CISOs should know.”
    • “The very capabilities that make an AI agent useful also make it dangerous. Here’s what CISOs should know about the agentic AI lethal trifecta, and what they should do about it.”
  • Security Week explains “How to Conduct a Successful Audit of AI-Driven Software Development.”
    • “As AI-generated code becomes commonplace, CISOs need new audit strategies to measure developer practices, govern AI tool usage, and identify software risks before they reach production.”
  • Here’s a link to Dark Reading’s CISO Corner.

Pre-holiday weekend report

David Ermer–Agentic & Generative AI, CDC, CMS, Congress, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

Note — The FEHBlog will be writing his weekly cybersecurity report tomorrow and will resume regular FEHBlog posts on Sunday July 5. Happy Independence Day! We are so blessed to be Americans.

From Washington, DC,

  • Roll Call reports,
    • “As America gets ready to celebrate its 250th birthday, Congress is taking a road trip back to the place where it all began — Independence Hall in Philadelphia. 
    • “Led by Pennsylvania Democratic Rep. Brendan F. Boyle, members will gather for a ceremonial event Thursday in his hometown, an effort Boyle said was two years in the making. 
    • “This is going to be truly one of the highlights of my tenure in Congress, to be sitting there where our Founding Fathers sat exactly 250 years prior, to the exact day,” Boyle said, adding he hoped it could be a rare “unifying moment.” 
    • “While July 4 gets most of the fanfare, Boyle said its lesser-known neighbor, July 2, deserves more attention as the day the Second Continental Congress voted to declare independence from Great Britain in 1776. 
    • “It was always the date that John Adams thought would be celebrated as America’s birthday. Unfortunately, this was another instance in which Adams lost to [Thomas] Jefferson — because Americans came to, of course, celebrate two days later the Fourth of July, which is the date Congress adopted the Declaration of Independence,” he said.” 
  • OPM Director Scott Kupor added a third post (OPM.gov link) to his Secrets of OPM blog this week. In this post, Director Kupor commemorates the new paperless federal retirement system by spurning the altar of Michael Scott, the fictious paper czar of Scranton, PA.
  • Healthcare Dive reports,
    • “The CMS proposed a rule on Thursday that would slash Medicare payment rates for a program [known as 340B] that hospitals use to buy discounted drugs and implement site-neutral payments for some imaging services next year.
    • Reforming the 340B drug discount program and better equalizing payments between sites of care have been priorities in the second Trump administration. Thursday’s proposed rule builds upon those agendas, including by expanding the services subject to site-neutral payments and more aggressively tamping down on discounts given to hospitals in the 340B drug program, which regulators previously tried to overhaul before dialing down their efforts in the face of opposition from the industry.
    • Medicare officials said the proposed rule would control costs and ensure Medicare money is directed toward “clinically appropriate” care. * * *
    • “The 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center rule proposes to increase pay for outpatient care by 2.4%, slightly less generous than the 2.6% rate update finalized last year.
    • “The rule would request information from stakeholders about how hospitals post publicly available price data, an ongoing priority for the Trump administration. Additionally, if finalized, the rule would allow certain accrediting organizations to assess hospitals on their compliance with laws regarding emergency care.”
  • The American Hospital Association News tells us,
    • “The House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions July 1 examined whether direct health care contracts between employers and providers could help address rising health care costs. During the hearing, lawmakers from both parties expressed interest in arrangements that bypass traditional insurers, with supporters citing lower costs, reduced administrative burdens and improved access to care. Witnesses highlighted advantages such as simplified billing, price transparency and direct primary care services, while lawmakers also discussed the need for greater insurer transparency and access to health plan data. The committee did not signal specific legislative proposals following the hearing.”
  • and
    • “The Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity published updated standard operating procedures for the individual access services exchange protocol and new FAQs. The revised SOP removed references to “TEFCA IAS Consent” workflows and associated patient matching methodologies, retaining the ability for providers to verify requests for access and use of data. Updates were made based on recommendations that the AHA and other stakeholders provided to SOP proposals. The SOP will be effective Aug. 3, 2026.”

No Surprises Act news

  • Federal Hearings and Appeals Services, which is certified IDR entity, tells us about
    • “The Cooling Off Period: What Providers and Health Plans Need to Know
      • “What is actually changing with the cooling off period under the final rule for the federal IDR program? To help clarify both the ongoing rules, the coming changes, and their timing, FHAS is offering two new tools to support parties.
        • “First, a new guide to the cooling off period explains which claims are subject to the cooling off period, how long it lasts, what will change under the final rule, and when those changes are coming.
        • “Second, FHAS has launched a new Cooling-Off Calculator which parties can use today to determine cooling off period dates and new dispute initiation timeframes. FHAS can help your team understand, anticipate, and implement changes directed by the final rule.”

From the judicial front,

  • Healthcare Dive reports,
    • “Elevance is suing the CMS after the agency recalculated the Medicare Advantage star ratings of a competitor in a more favorable way than it did for other plans.
    • “After losing a lawsuit earlier this year, the CMS reran 2026 quality scores for Clover Health, dropping 20 measures that a judge ruled could not be factored in. Regulators then recalculated stars for other MA insurers last month, but cut out extra measures, too — measures that Elevance performed well on, the insurer argued in its complaint filed Wednesday in Georgia district court.
    • “Elevance says it lost out on $115 million in bonus payments as a result. The company is asking the court to force CMS to redo its own ratings using the same methodology as for Clover.”
  • STAT News relates,
    • “In a victory for the pharmaceutical industry, a federal judge blocked a Colorado state panel from placing a cap on the price of a blockbuster drug sold by Amgen after deciding the company is “likely to be significantly harmed.”
    • “The ruling pauses a controversial, first-in-the-nation move by the Colorado Prescription Drug Affordability Board, which was created four years ago in response to the rising cost of prescription medicines and is permitted to set upper payment limits on what most state residents will pay for selected drugs.” * * *
    • “Last October, the board then voted to limit what health plans in the state will pay for the drug. The board capped Enbrel prices at $600 for a ​50-milligram weekly dose, or $30,350 a year per person, effective on January 1, 2027. That compared with roughly $53,000 that the average plan in the state paid in 2023, according to a state claims database.
    • “The drugmaker then quickly filed a second lawsuit, reiterating its earlier arguments. Meanwhile, the company had until July 5 to decide whether to continue selling the treatment, which has a list price exceeding $100,000 a year and generated $2.23 billion in sales last year, in Colorado.
    • “But Judge Daniel Domenico of the U.S. District Court in Denver agreed with the company. In his ruling, which was issued on Wednesday, he noted that the state has a ​legitimate interest in helping patients afford Enbrel, but “capping the price of a patented drug” is not an ​option.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “The U.S. overall death rate in 2025 fell to its lowest point on record, even as influenza and pneumonia are now among the nation’s top 10 causes of death for the first time in years, according to new data from the Centers for Disease Control and Prevention.
    • “The death rate fell 4.6% last year, to 689.2 deaths per 100,000 people, down from 722.1 in 2024, according to the CDC’s National Center for Health Statistics. The death rate declined across every age group and nearly every demographic group tracked in the provisional report.
    • “The main driver of the record low was a continued drop in drug overdose deaths, said Farida Ahmad, a health scientist at the CDC and one of the report’s co-authors. Another factor, she added, was that Covid-19 no longer contributed to as many deaths.
    • “Against that backdrop, influenza and pneumonia stood out—moving from 11th to eighth place in all age groups—with 56,511 deaths in 2025 compared with 48,139 in 2024. It is the first time the influenza category has cracked the top 10 since 2020.”
  • AAMC relates,
    • “Patients arrive in the emergency department (ED) doubled over in pain and retching uncontrollably, a brew of symptoms physicians have nicknamed “scromiting” — a combination of screaming and vomiting. The problem: an underrecognized consequence of cannabis use called cannabinoid hyperemesis syndrome (CHS), and emergency medicine physicians say few conditions leave patients more obviously miserable.
    • “My heart breaks for them,” says Kathleen Clem, MD, an emergency medicine physician at Dartmouth Health in Lebanon, New Hampshire, and interim associate dean for faculty affairs at the Geisel School of Medicine at Dartmouth. “They come in because they absolutely cannot keep anything down. They’re dehydrated and their belly is sore from vomiting so much. Sometimes they vomit so much, they’ll break little blood vessels in their esophagus, and little bits of blood come up with that.”
    • “The leading cause of marijuana-related ED visits, CHS is associated with the chronic and long-term use of marijuana products, and it is becoming more prevalent, likely due to the increased legalization of marijuana. Some 24 states have legalized recreational marijuana use since 2012, and 40 states allow its use as a medicinal treatment. An additional eight states allow “limited-access” medical cannabis, which refers to low-THC (tetrahydrocannabinol) products and CBD (cannabinoid) oil.
    • “In the United States, cannabis use has nearly doubled in the past decade, with 22.3% of individuals 12 years and older — 64.2 million people — reporting its use in the past year, up from 12.6% in 2013, according to data from the Substance Abuse and Mental Health Services Administration. And research shows a 15-fold increase in the number of people reporting daily or near daily cannabis use from 1992 to 2022.”
  • The Today Show adds,
    • “Cyclosporiasis, a nasty parasitic infection that causes “explosive” watery diarrhea, has sickened dozens of people in Michigan and other parts of the United States.
    • “Cases of the gastrointestinal illness, caused by a parasite that spreads through contaminated food, have been on the rise in multiple states since May, according to the U.S. Centers for Disease Control and Prevention. At least 20 people have been hospitalized nationwide so far. 
    • “The CDC is working to identify potential sources of the parasitic infection, which is commonly linked to fresh produce.” * * *
    • “The U.S. typically sees several hundred cases of cyclosporiasis annually. In recent years, the number of infections reported in the U.S. has increased significantly.” * * *
    • “The best way to prevent infection is to avoid consuming food or water that may be contaminated with feces, the CDC says. Following proper hand hygiene and safe food handling practices can also lower your risk of foodborne illness.”
  • The New York Times points out,
    • Habitual users of fentanyl have developed such a strong tolerance to the drug that standard doses of medications to manage withdrawal and initiate recovery are no longer working for many patients, a team of researchers in Los Angeles has found.
    • Their study, published in the journal Drug and Alcohol Dependence, presents a picture of the dangerous volatility of the city’s street supply and the capacity of users to tolerate ever greater amounts of pure fentanyl, which is at least 50 times more potent than heroin.
    • “In a summary of the findings, Morgan Godvin, one of the lead authors of the study and a health services researcher at the University of California, Los Angeles, said that a seasoned user’s daily street dose of fentanyl was roughly equivalent to 1,250 hospital doses of 100 micrograms of fentanyl given during and after surgery.
    • “In any other context, that would be unsurvivable,” she wrote. “Among people who use fentanyl every day, it is routine.”
    • “The study reinforces the belief among many addiction experts that, for high-tolerance patients, the standard treatment regimens for opioid addiction have become outdated. Doses of medications such as buprenorphine and methadone, opioids that help satisfy cravings without inducing a high, were calculated to treat addictions to heroin and prescription painkillers. The results of the new research, experts said, support a growing call by clinicians for treatment guidelines to be revised to keep pace with the convulsive drug market.”
  • MedPage Today tells us,
    • “A global study showed that body mass index-associated gaps in blood pressure and cholesterol have diminished from 1990 to 2024.
    • “With more medications being used, older people with obesity were metabolically similar to, and in some countries even lower risk than, people with a normal BMI.
    • “Young adults with obesity remain metabolically higher risk, however, and should be a focus of prevention and treatment, some say.”
  • Genetic Engineering and Biotechnology News informs us,
    • “For nearly half a century, scientists have known that malaria parasites force their way into human red blood cells (RBCs) through a ring-shaped structure called the moving junction (MJ). What no one could work out was what it actually does. The structure assembles, does its job, and dissipates in the space of 60 seconds—gone before anyone can get a close look.
    • “A team at Columbia University has now finally caught the moving junction in the act. By freezing parasites at the onset of invasion and lifting the intact complex straight out of the cell, the researchers obtained the first high-resolution view of its three-dimensional structure. What they saw overturned a decades-old assumption about how the parasite gets in. Rather than a passive doorway, the moving junction turns out to be a molecular machine that actively remodels the host cell’s membrane to help the parasite force its way inside.
    • “The findings detail how the team obtained the structure and then used it as a blueprint to design a mini-protein, from scratch, that blocks invasion—a proof of concept for a new kind of antimalarial drug.”
  • The Washington Post lets us know,
    • “When it comes to dementia risk, certain factors, such as genetics, are out of your control. However, plenty of research suggests lifestyle behaviors— things you can change — may help improve your chances of staying sharp as you age. In a new study, people with an elevated risk of dementia were less likely to develop the condition if they followed a healthy dietary pattern, particularly a less inflammatory one.”
  • Per BioPharma Dive,
    • “Roche’s experimental medicine divarasib helped patients with a certain type of lung cancer live longer than two approved treatments in a new study.
    • “The Phase 3 trial compared divarasib with Amgen’s Lumakra and Bristol Myers Squibb’s Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday.
    • “Roche did not release detailed data, saying the results would be presented at an upcoming medical meeting. There were no new safety findings of concern and most treatment-related side effects were “manageable and reversible,” the company said.”

From the U.S. healthcare business front,

  • Healthexec reports,
    • With Election Day only four months away, healthcare is again emerging as a major source of idealistic campaign promises. Many of these are driven by widespread public angst. What sorts of changes can U.S. healthcare stakeholders realistically expect once the results are in? 
    • “Professional prognosticators at the global accounting and consulting firm PricewaterhouseCoopers, aka PwC, have considered the policy possibilities and are sharing their thinking in writing. * * * PwC offers forward-looking insights and advice for organizations across healthcare’s four major subsectors. 
      • “PROVIDERS: Policy drivers are reshaping delivery and access. 
        Healthcare providers will do well to “examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain,” PwC comments. 
        ‘This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.’
      • “PAYERS: Policy drivers are reshaping cost structures. 
        “Healthcare payers will likely need to strengthen care management capabilities as they expand their holistic support to members, the analysts forecast. 
        ‘This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans.’
      • “PHARMA: Policy drivers are reshaping pipeline decisions, regulatory strategy and market access. 
        “In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, “should expand from drug manufacturers to ‘lifespan partners,’ requiring more agile operating models and greater collaboration across technology, and ecosystem players,” the authors write.  
        ‘In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.’
      • “MEDTECH: Policy drivers are reducing federal oversight of AI-powered and wellness devices. 
        “Going forward, the subsector is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home, PwC remarks. 
        ‘MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.’
  • Cardiovascular News relates,
    • “The American College of Cardiology (ACC) reached a major milestone this summer; its highest honor, the HeartCARE Center National Distinction of Excellence, has officially been awarded to 100 U.S. hospitals [all of which are listed in the article]. 
    • “The ACC established the HeartCARE Center designation in 2018 to celebrate hospitals and health systems that “demonstrate ongoing excellence through comprehensive accreditation, data-driven performance measurement and continuous quality improvement initiatives.” Recipients must be “forward-thinking organizations” that participate in ACC Accreditation Services programs, NCDR registries and other quality improvement campaigns focused on cardiovascular health.
    • “Reaching 100 hospitals recognized as ACC HeartCARE Centers marks an important milestone in our ongoing effort to elevate the standard of cardiovascular care,” Steven B. Deitelzweig, MD, chair of the ACC Accreditation Oversight Committee, said in a statement. “Each of these institutions has demonstrated a deep commitment to evidence-based care, continuous quality improvement and measurable outcomes—ensuring that patients receive the highest level of cardiovascular care, no matter where they live.”
  • Beckers Hospital News tells us,
    • “The Kroger Co. will acquire supermarket chain Giant Eagle, Inc. for $1.65 billion, expanding its pharmacy footprint across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.
    • “Giant Eagle operates 11 standalone pharmacies, according to a July 1 news release. Kroger said the acquisition will strengthen its presence in adjacent markets and build on Giant Eagle’s pharmacy business, loyalty program and private label portfolio. 
    • “The deal adds to Kroger’s pharmacy footprint at a time when retail pharmacy access is contracting elsewhere in the industry, with Walgreens restructuring into five standalone companies following multibillion-dollar operating losses and Rite Aid’s footprint largely gone — a gap health systems have increasingly stepped in to fill by opening their own pharmacies.” 
  • MedTech Dive informs us,
    • “Guardant Health said Wednesday its Shield test for colorectal cancer is now covered by UnitedHealth, the first major private U.S. health insurer to reimburse for the screening.
    • “The decision by UnitedHealth, the largest private U.S. health insurer, expands access to the screening to about 100 million Americans, the company said.
    • “Canaccord Genuity analyst Kyle Mikson, in a note to clients, called the coverage decision a “watershed moment” for liquid biopsy-based cancer screening and for the category of blood-based cancer testing.”

Wednesday report

David Ermer–Agentic & Generative AI, CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

HAPPY NATIONAL POSTAL WORKERS DAY!

From Washington, DC,

Plenty of news from the U.S. Office of Personnel Management today.

  • Per an OPM news release,
    • “Today, the US Office of Personnel Management (OPM) announced the “Last Day of Paper,” officially ending paper retirement processing for more than 95 percent of federal retirement applications and completing the agency’s transition to a fully digital retirement process.
    • “For decades, federal retirement applications relied on a paper-based process that required physical documents to move between agencies, payroll providers, and OPM’s Retirement Operations Center in Boyers, Pennsylvania. As of yesterday, nearly all retirement applications will be submitted and processed electronically through OPM’s Online Retirement Application (ORA), eliminating paper from the process and significantly reducing processing times.
    • “The milestone follows rapid adoption of ORA, which has processed more than 155,000 retirement applications over the past year after serving only a few hundred users during its initial rollout.” * * *
      • “As part of today’s milestone, OPM is also launching new capabilities designed to accelerate retirement processing, including:
      • “A new pre-retirement application that allows employees and agency HR offices to complete much of the retirement process before an employee’s separation date.
      • “Earlier processing of retirement applications while final payroll information is still being finalized, reducing unnecessary delays.
      • “A commitment to issue a retiree’s first pension payment within seven days of retirement for applicants who submit a complete retirement package by their separation date.”
  • FEHBlog observation – While OPM deserves credit for this accomplishment, the agency has not announced implementing the HIPAA standard transaction 820 which is an electronic enrollment roster that would allow carriers to reconcile premiums to individual enrollments. The HIPAA 820 has been around since 2012. Carrier systems must accept the HIPAA 820. What is the sense in collecting family member eligibility documents when no one currently knows whether the enrollee is paying the proper premium?
  • Govexec adds,
    • “The federal government’s 401(k)-style retirement savings program posted mixed results in June, ending two straight months of consistent growth.
    • “The Thrift Savings Plan’s S Fund, which is made up of small- and mid-size businesses, saw the best performance, gaining 4.34% last month. Since January, the S Fund has grown 18.41%.
    • “The fixed income (F) fund increased 0.25% last month, bringing its 2026 performance to 0.74%. And the G Fund, which is made up of government securities, increased by its statutorily mandated rate of 0.37%. So far this year, the G Fund has swelled 2.18%.
    • “But the I Fund was virtually flat in June, losing 0.03%. That brings the I Fund’s 2026 performance to 16.53%. And the C Fund’s common stocks fell 0.95%, bringing its gains since January down to 10.20%.”
    • The performance of other funds can be found in the article.
  • Another OPM news release tells us,
    • “The US Office of Personnel Management (OPM) today proposed sweeping reforms to modernize how agencies address poor performance, streamline disciplinary and removal procedures, and strengthen accountability across the federal workforce.
    • The proposed rule would require agencies to better equip supervisors with training on employee accountability while making it easier to address employee performance issues. Among other reforms, the proposal establishes a default 30-day Performance Improvement Plan (PIP), eliminates pre-PIPs that unnecessarily delay action, standardizes employee response periods for adverse actions, and modernizes Merit Systems Protection Board review of adverse action appeals by replacing the current checklist-based approach (called “the Douglas factors”) with a totality-of-the-circumstances standard.
    • This proposal is part of the Trump Administration’s broader effort to build a high-performing federal workforce that rewards excellence, recognizes strong performance, and holds employees accountable when performance falls short.” * * *
    • “The proposed rule will be published in the Federal Register and will be open for public comment. Read Director Kupor’s blog post on this here.”
  • OPM Director Scott Kupor added a second post to this Secrets of OPM blog today. The second post is titled “Measure what matters.”
    • “Last year, we postponed the Federal Employee Viewpoint Survey (FEVS) and critics were quick to claim that we at OPM did not believe in employee engagement surveys. That couldn’t be farther from the truth. * * *
    • So, today we announced that OPM will no longer centrally administer FEVS. As a centrally-administered system, it’s costly, doesn’t serve as a valuable management tool and fails to enable actionable results. That serves nobody well.
    • Instead, we have provided detailed guidance to agencies on how best to design surveys that meet their specific needs. That guidance includes a common set of core questions that every agency will ask—ensuring we preserve the ability to track government-wide trends and maintain a coherent thread of data across the federal workforce. The goal isn’t fragmentation; it’s better ownership. Agencies will have the flexibility to go deeper where their missions demand it, while OPM retains the visibility to understand the broader landscape and identify where systemic challenges require government-wide attention.”
  • Federal News Network reports,
    • “President Donald Trump said Monday [June 29] he will nominate Keith Sonderling to be the secretary of labor, elevating him from the agency’s acting director two months after Lori Chavez-DeRemer resigned amid abuse-of-power allegations.
    • “Sonderling, a lawyer who has held a variety of acting positions and leadership roles across Trump’s government, was previously the deputy labor secretary and a Republican member of the Equal Employment Opportunity Commission.
    • “Throughout his career, Keith has proven his dedication to delivering strong results for the Hardworking People of our Country, and I know he will do an incredible job in his new role,” Trump wrote in a Truth Social postannouncing Sonderling’s nomination.
    • Sonderling’s nomination is subject to Senate confirmation.
  • Fierce Healthcare relates,
    • “The Trump administration has officially launched its new “bridge” model that brings GLP-1 coverage for weight loss to Medicare beneficiaries.
    • “Eligible people enrolled in Medicare Part D can secure certain GLP-1 medications for weight loss or management at $50 each month. The program will remain in place through the end of 2027, the Centers for Medicare & Medicaid Services said in an announcement.
    • ‘Under the GLP-1 bridge, the feds will cover the cost of expanded coverage. Alongside this model, the agency also proposed a second approach—called Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth, or BALANCE—in which it would negotiate lower GLP-1 prices in exchange for standardized coverage options.
    • “Plans balked at the model, and CMS indefinitely delayed from a planned January 2027 start date. A similar model was implemented in Medicaid in May 2026.
    • “In a CMS announcement commemorating the model’s launch, Administrator Mehmet Oz, M.D., urged beneficiaries to reach out to their doctors to see if they’re eligible.
    • “For too long, many Americans have been unable to access these treatments because of cost,” Oz said.”
  • Per a CMS news release,
    • “The Centers for Medicare & Medicaid Services (CMS) is proposing new safeguards to ensure taxpayers aren’t on the hook for noncompliant Medicare providers and suppliers, continuing its campaign to crush fraud, waste, and abuse throughout its programs and hold bad actors accountable. The Calendar Year (CY) 2027 Home Health Prospective Payment System (PPS) proposed rule would strengthen CMS’ ability to recover improper payments and remove non-compliant providers and suppliers from Medicare, actions estimated to save approximately $82 million in annual savings, while also expanding access for patients receiving care at home and improving the timeliness of publicly reported home health agency quality information.”
    • * * * “The proposed rule also would update Medicare home health payment rates for CY 2027. At the same time CMS is strengthening oversight and crushing fraud, waste, and abuse, the agency is proposing targeted payment updates that support access to care for beneficiaries who rely on home health services. CMS is also proposing to continue to fulfill its statutory obligation to transition the Home Health PPS to the Patient-Driven Groupings Model in a budget-neutral manner. CMS estimates total Medicare payments to home health agencies would increase by approximately 2.4%, or $420 million, compared to CY 2026.” * * *
    • “To view a fact sheet on the proposed rule, visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-home-health-prospective-payment-system-proposed-rule-fact-sheet-cms-1844-p. 
    • “The proposed rule can be viewed on the Federal Register at: https://www.federalregister.gov/d/2026-13602.” 
       
  • Per a GAO news release,
    • “A leading cause of death in the U.S., suicide resulted in more than 49,000 deaths in 2023. That’s up by 31% from 2003.
    • “To help those at risk, the federal government set up the 988 Suicide & Crisis Lifeline. It offers support via call, text, and chat.
    • “Since the Lifeline’s inception in July 2022 through September 2025, we found:
      • “Call, text, and chat contact volume increased
      • “Call answer rates increased, while text and chat answer rates varied
      • “Average time to answer calls, texts, and chats varied
    • “We also found that the federal government set goals for the Lifeline. It collected data related to those goals and used it to assess its performance.”
  • HR Dive points out,
    • “The U.S. Equal Employment Opportunity Commission rescinded its affirmative action guidelines Tuesday, eliminating an interpretation that had persisted for 40 years.
    • “According to a June 30 statement, the guide and a related compliance manual “ran afoul” of Title VII of the Civil Rights Act of 1964 and more recent U.S Supreme Court rulings in the eyes of the commissioner. Almost three years ago to the day, the high court issued its decision in Students for Fair Admissions, Inc. v. Harvard, holding that race-conscious admissions practices at two universities were unconstitutional.” * * *
    • “The takeaway from the new plan should not be to “abandon lawful EEO efforts, but to ensure policies do not use protected characteristics as selection criteria,” management-side attorney Randi Hyatt, a partner at Whiteford, Taylor & Preston, said in an analysis.”

No Surprises Act News

  • Fierce Healthcare reports,
    • “Healthcare technology company Zelis rolled out an AI-native solution to help health plans manage Independent Dispute Resolution complexity under the No Surprises Act.
    • “Independent Dispute Resolution (IDR) is the process for adjudicating out-of-network claims created by 2020’s No Surprises Act (NSA).
    • “Zelis’ solution uses AI to automate payers’ workflows, from claim repricing, open negotiation, dispute prevention, case management and IDR resolution. The company unveiled the new solution as dispute volume, compliance requirements and process deadlines pressure payer operations, executives said.”

From the Food and Drug Administration front,

  • Per an FDA news release,
    • The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). This is the first gene therapy approved for patients aged 2 years and older with SCD.  
    • Casgevy has been previously approved for the treatment of patients aged 12 years and older with SCD with recurrent VOCs or TDT.  
    • “With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “The FDA is committed to prioritizing and speeding up the review of products that address critical U.S health priorities through expedited review programs, including the FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program. These initiatives are designed to advance therapies for diseases with significant unmet medical needs, enabling faster access to innovative treatments while upholding the FDA’s rigorous gold-standard requirements for safety and effectiveness.”  
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today commended the Drug Enforcement Administration’s (DEA) issuance of two Notices of Intent to begin the temporary scheduling process for certain kratom-related substances.
    • ‘One Notice of Intent addresses temporary placement of 7-OH above a specified threshold in Schedule I, while the second would temporarily place three synthetic 7-OH derivatives into Schedule I of the Controlled Substances Act (CSA):
      • “Mitragynine pseudoindoxyl (MP)
      • “Dihydro-7-hydroxymitragynine (MGM-15)
      • “The 9-fluoro derivative of 7-hydroxymitragynine (MGM-16)
    • “Concurrent with DEA’s Notice of Intent addressing 7-OH, the Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) on seeking public comment on the proposed 7-OH threshold level in the NOI. The request is limited to obtaining comments on whether: 1) there is additional scientific data to support the proposed or an alternative threshold level – specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety; and 2) data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety.
    • “After the 30-day comment period for the RFI, OASH will provide comments submitted to the RFI public docket to the Attorney General for consideration. Once comments have been considered and at least 30 days have passed since the publication of the NOI, the Attorney General may then issue a temporary scheduling order placing 7-OH above a certain threshold in Schedule I. The CSA provides the Attorney General with the authority to issue a temporary scheduling order placing a substance in Schedule I of the CSA for two years, if such action is necessary to avoid an imminent hazard to public safety.”
  • Cardiovascular Business relates,
    • “Amgen is recalling nearly 935,000 bottles of ivabradine, a heart failure drug the company sells under the brand name Corlanor, due to the presence of a foreign substance. 
    • “The recall includes specifics lots of 5-mg and 7.5-mg Corlanor tablets manufactured in Italy and then distributed by Amgen throughout the United States. The drugs are packaged in 14- and 60-tablet bottles. Expiration dates range from July 2026 to December 2028.
    • “The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means taking the drugs in question could cause “temporary or medically reversible adverse health consequences.”
    • “Amgen first received FDA approval for ivabradine in April 2015. The agency’s decision was largely based on data from the SHIFT trial, which included more than 6,500 patients randomized patients treated with ivabradine or a placebo. In 2021, researchers found that ivabradine could be used to treat symptoms associated with postural orthostatic tachycardia syndrome in COVID-19 patients.”
  • MedTech Dive adds,
    • “The Food and Drug Administration has reported 252 injuries were associated with Hologic’s BioZorb radiographic markers implanted in the breast and other soft tissue sites during medical procedures. No deaths were reported.
    • “The update comes almost two years after Hologic told customers to stop using the devices due to reports of adverse events such as pain, infection and device migration. At the time, Hologic said it had received 188 complaints associated with adverse events.
    • “In its latest communication, the FDA repeated Hologic’s instructions advising healthcare providers not to use the BioZorb markers. Patients should be monitored for signs of adverse events, but Hologic said there is no need to have an implanted marker removed from the body.”
  • Beckers Hospital Review tells us,
    • “Cisplatin, carboplatin, oxaliplatin and ifosfamide remain in active shortage, and manufacturers’ latest estimates show full resupply of some formulations will not arrive until October, according to updates posted by the American Society of Health-System Pharmacists. 
    • “The four chemotherapy drugs form the backbone of treatment for breast, lung, ovarian, testicular, bladder, and head and neck cancers. Becker’s previously reported that hospitals and cancer clinics working with group purchasing organization Premier received only 38% of their ifosfamide orders and about two-thirds of their cisplatin orders in recent weeks, prompting some healthcare organizations to space out doses and prioritize patients most likely to benefit from treatment.”
  • BioPharma Dive identifies “5 FDA decisions to watch in the third quarter of 2026.”
    • “A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “West Nile virus activity is starting earlier than it has in years, with the CDC warning it is now seeing the highest number of human cases of the nasty mosquito-borne disease since 2004.
    • ‘At least 48 cases had been reported as of Tuesday, and 38 have involved serious illness affecting the brain or nervous system. 
    • “For comparison, by the end of June, the Centers for Disease Control and Prevention usually sees only about 10 human cases. The earlier start could be problematic, as it extends the amount of time people could be exposed to the disease before the season dies down in colder months.” * * *
    • “Arizona has reported the highest number of cases in the country at 32. Maricopa County, the state’s most populous county, has reported 29 cases, including four deaths, already more than half of the case total it reported in all of 2025.”
  • Drug Topics relates
    • “Surveillance through June 2026 shows widespread, outbreak-driven measles transmission, with 93% of cases in unvaccinated/unknown-status individuals and 6% requiring hospitalization. 
    • “Erosion of kindergarten MMR coverage from 95.2% to 92.5% leaves hundreds of thousands susceptible, while subregional coverage can fall near 50%, enabling explosive outbreaks. 
    • “Utah’s large outbreak prompted enhanced monitoring, including wastewater-based detection, and recommendations for earlier MMR dosing (from 6 months) to mitigate infant risk. 
    • “Persistent misinformation and vaccine hesitancy necessitate motivational interviewing techniques (OARS, readiness rulers) and proactive pharmacist-led community engagement to rebuild trust and uptake.”
  • Managed Health Executive points out,
    • “Physical inactivity and racial and ethnic minority status emerged as the two strongest predictors of diabetes prevalence across U.S. counties in a new machine-learning analysis published in Diabetes/Metabolism Research and Reviews.
    • “The cross-sectional study, led by Nicolaas P. Pronk, Ph.D., of the HealthPartners Institute, set out to capture what the authors call the “multilevel ecology” behind diabetes, defined as the mix of broad structural forces and individual-level behaviors that impact diabetes development.”
  • Beckers Clinical Leadership lets us know about “Lung cancer screening, mortality and incidence — by state.”
    • “At 11%, California had the lowest up-to-date lung cancer screening rate in 2024, while Connecticut, Massachusetts and Pennsylvania had the highest rate at 28%, according to American Cancer Society data. 
    • “The national median rate for up-to-date lung cancer screening in 2024 was 18%.
    • “Lung cancer mortality and incidence remain highest in Kentucky and West Virginia, despite having above-average lung cancer screening rates.” 
  • Health Day tells us,
    • “Stepped alcohol treatment (SAT) offered via telehealth helps people with chronic liver disease (CLD) reduce alcohol consumption, according to a study published online June 24 in Hepatology.
    • “Derek D. Satre, Ph.D., from the University of California, San Francisco (UCSF), and colleagues evaluated the efficacy of telehealth SAT, which consisted of three motivational interviewing sessions followed by addiction medicine referral if no drinking reduction at month 3. One hundred fifty-seven adults with CLD and unhealthy alcohol use (>7 drinks/week or ≥4/day for women; >14/week or ≥5/day for men; or heavy episodic drinking) were randomly assigned to SAT (81 participants) or usual care (76 participants). 
    • “The researchers found that SAT had no difference in percentage of alcohol use below moderate level (primary outcome) versus usual care. However, SAT had greater reduction in drinks/week from baseline to month 3 and month 6 (estimates, −0.66 and −0.67, respectively) (secondary outcome). Compared to usual care, the six-month effect of SAT on alcohol use reduction remained significant when controlling for covariates. The 30-day abstinence rates were 29 percent for SAT and 18 percent for usual care at month 6. There was a positive association between baseline motivation to reduce alcohol use and treatment response.”
  • The latest NIH Research Matter covers the following topics:
    • “Alzheimer’s proteins in blood linked to midlife cognition 
      • “A study found that people in midlife with more Alzheimer’s-related proteins in their blood had worse cognitive function.
      • “The results suggest blood tests could one day help identify people who may benefit from early efforts to delay Alzheimer’s symptoms.”
    • “Genetic testing may benefit more patients with melanoma 
      • “Researchers found people diagnosed with melanoma at a young age or with multiple melanomas were more likely to carry a genetic mutation.
      • “The findings suggest that certain patients with melanoma could benefit from genetic testing to identify mutations and potential risk for other types of cancer.”
    • “Senescent cells mapped in human body over the lifespan
      • “Scientists located and classified senescent cells, a hallmark of aging, to begin building an atlas of these non-dividing cells in the human body.
      • “The atlas could help track how senescent cells drive age-related conditions and may inform treatment strategies for age-related diseases.”
  • The University of Minnesota’s CIDRAP notes,
    • “Vaccine myths are not new. They have circulated for decades, surviving retracted studies and countless public health campaigns. Now, a new poll suggests that, while relatively few Americans fully believe those falsehoods, many remain uncertain about them—a finding that suggests opportunities to counter vaccine misinformation.” * * *
    • “The poll found a strong association between trust in healthcare providers and vaccine attitudes, with adults who have a provider they trust being less likely to believe vaccine myths.
    • “Just under half of adults (46%) who do not have a trusted healthcare provider to answer questions about their health said it was “probably” or “definitely true” that more people have died from COVID vaccines than from COVID itself. That’s almost twice as many as those who reported having a trusted provider (24%). 
    • “Researchers noted that the relationship remained significant even after accounting for factors such as age, race and ethnicity, education, political affiliation, and insurance status.”
  • Per BioPharma Dive,
    • “Shares of Paris-based biotechnology company Abivax surged nearly 40% Tuesday following the release of supplementary Phase 3 data on its inflammatory bowel disease drug that cleared away investors’ concerns about increased cancer risk.
    • “Abivax said cancer rates seen across enrollees in its Phase 2 and Phase 3 trials were no higher than the “background” one seen in people with ulcerative colitis, which is higher than the general population in certain types of malignancies.
    • “The update from the second part of that Phase 3 trial — which enrolled people who didn’t respond to the drug or relapsed during the trial — added safety data that “appropriately addresses the key overhang facing the stock,” wrote Jefferies analyst Faisal Khurshid in a client note. Abivax followed the share price increase with an $800 million sale of its U.S. listed shares.”

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

  • Modern Healthcare reports,
    • “Brian Evanko, Cigna Group’s new chief executive officer, said he aims to put patients at the center of the company’s strategy. He’ll have to convince people struggling with rising healthcare costs that he’s serious — and persuade Wall Street that this strategy can be profitable. 
    • “That’s been a difficult balancing act for Cigna. Last year the company announced that it would phase out rebate payments from drug companies in many of its prescription plans, pulling back from a “middleman” practice the Trump administration has criticized.
    • “Cigna said this would lower patient costs and only temporarily shrink profits. But investors punished Cigna with its worst selloff in 17 years. Its shares still haven’t recovered.”
    • “It’s a tension Evanko will have to navigate beginning Wednesday when he becomes the public face of Cigna, a giant in medical insurance, prescription drug benefits and specialized pharmacy services. Insurers are under fire in Washington for high costs. Employer clients are balking at premium hikes. Patients are frustrated with spending-control tactics like prior approvals. And investors are wary that addressing those concerns could erode profits.
    • “Evanko said he’s focused on making Cigna more responsive to the 185 million people who use its healthcare services, the bulk of whom have prescription drug coverage managed by the business.
    • “For me, coming into the role, importantly, we’re going to put the customer at the center of everything we do, so being patient-first,” Evanko, 50, said in a recent interview at Bloomberg’s New York headquarters. “We see that as actually a strategic choice.”
  • Beckers Payer Issues relates,
    • “Hospitals and insurers have been fighting an AI billing war for the better part of two years, with providers deploying the technology to optimize and defend their coding, and payers using it to audit and push back.
    • “AI is placing pressure on cost through RCM tools, and we have seen those patterns in terms of service intensity, and cost per encounter going up,” UnitedHealthcare CEO Tim Noel said at a June media event attended by Becker’s. “It clearly has occurred, and that is a source and driver of trend. I don’t think that that’s going to be persistent. That’s a moment that we’re in that will get to saturation.”
    • “Revenue cycle executives and physicians have described the ongoing dynamic as an “AI arms race,” that has been adding administrative cost and friction on both sides. This month, PwC projected that employers’ medical cost trend will reach its highest level in 17 years in 2027, pointing to provider adoption of AI documentation and coding tools as one of five primary inflators. Nearly 70% of surveyed health plans ranked it among their top three concerns, and roughly 20% named it the single largest driver.
    • “Mr. Noel said UnitedHealthcare is already working to move beyond paid-claims data to understand “more upstream where these hot spots are.” 
    • “The global trends are the global trends, and there are some opportunities to address those in the moment, and we are,” he added. “But we also have to look for new sources of affordability moving forward.”
  • and
    • “Sustainability has become less about cutting costs and more about redesigning how healthcare delivers value. Becker’s asked several health plan leaders how they’re thinking about long-term sustainability, and the responses point to a shared shift away from volume-driven models toward outcomes, accountability, and member-centered design. From shifting social health programs toward measurable, evidence-based interventions to redesigning the consumer experience around choice and transparency, leaders are converging on the idea that sustainability isn’t a single initiative — it’s a durable operating model built for the long haul.
    • “The answers below reflect a range of strategies, from strengthening payer-provider partnerships and embedding AI into clinical decision-making to balancing financial discipline with health equity and community trust. Common threads emerge around reducing low-value care, building data infrastructure that supports proactive rather than reactive management, and designing systems flexible enough to adapt as member needs evolve. [In the article], healthcare leaders share how they’re positioning their organizations for what’s next.
  • Vizient discusses “From scale to orchestration: The new requirements for payer success.”
    • “For executive and board consideration:
      • “Evaluate strategic pathways, including independence, partnership, affiliation, or acquisition.
      • “Assess strengths and gaps across products, member diversification, scale, and market positioning
      • “Identify partners that align across strategy, governance, economics, and long-term objectives.
      • “Execute transactions and integrations with rigor and discipline.”
  • MedCity News considers,
    • “Healthcare’s Most Avoided Question: “How Much Exactly Do You Need, and What Will America Get in Return?”
      • “Before policymakers, employers, insurers, or taxpayers commit ever-larger sums to the system, an uncomfortable question deserves attention: How much additional capacity does healthcare actually need and what measurable outcomes should society expect in return?”
  • Modern Healthcare tells us,
    • “Allegheny Health Network closed its acquisition of Heritage Valley Health despite pushback from the Pennsylvania attorney general. 
    • “The deal adds Heritage’s two hospitals, dozens of clinics and 500 employed and affiliated physicians to the 16-hospital provider division of Highmark Health.
    • “A final order Friday from a federal court paved the way for the transaction’s close, with conditions. Last Wednesday, Pennsylvania Attorney General Dave Sunday (R) sued to block the transaction over potential anticompetitive effects. He claimed the acquisition could allegedly increase hospital and radiation oncology prices in Beaver County and Allegheny County.
    • “The order from U.S. District Court for the Western District of Pennsylvania Judge Maureen Kelly requires Allegheny Health to provide current services at the rebranded AHN Beaver Hospital – Heritage Valley and AHN Sewickley Hospital – Heritage Valley for at least five years and maintain an existing joint venture between Heritage Valley and UPMC Cancer Centers.
    • “In addition, Allegheny cannot terminate automatic renewal clauses in its insurer contracts for at least a year and it must pay Sunday $75,000 in legal fees, among other provisions.”
  • The Wall Street Journal informs us,
    • “Ipsen IPN said it agreed to buy Swiss biotechnology company Memo Therapeutics in a deal that could exceed 700 million euros ($799.6 million) and that seeks to expand the French drugmaker’s rare-disease portfolio.
    • “The move marks Ipsen’s second acquisition this week after its agreement to take over Kartos Therapeutics, a company developing a drug to treat a rare blood cancer, for up to $1.75 billion.
    • “Ipsen said it would pay 200 million euros initially and make deferred payments subject to certain development, regulatory approval and sales-based targets that could take the total price above 700 million euros.
    • “The deal focuses on Memo’s experimental drug potravitug for the treatment of nephropathy associated with BK polyomavirus, a complication in kidney transplant recipients, Ipsen said. The drug—which was granted fast-track designation from the U.S. Food and Drug Administration in 2023—is due to move to a mid- and late-stage clinical trial later this year, the company added.”
  • Fierce Healthcare points out,
    • “Patients are taking charge of their healthcare with artificial intelligence and other solutions, with 58% of U.S. patients researching symptoms before deciding whether to book an appointment, according to a new report from ZS Impact Institute. 
    • “The recent report drew insights from nearly 10,000 healthcare consumers and providers across the U.S., Germany and China. Researchers note the shift is consistent across healthcare systems, which they say points to a “broader breakdown in how patients seek and experience care globally.”
    • “Thirty-seven percent of U.S. respondents report using search engines for health information—94% of which find it helpful—and 18% report using AI. Eighty-nine percent of those using AI to find information report it being helpful.”
  • and
    • “Evernorth has unveiled a new specialty pharmacy program that leans on AI to support a better experience for patients with complex conditions.
    • “Called Pharmacy Forward, the program aims to use technology to drive more coordinated, connected care and to offer personalized supports in real time. Evernorth plans to launch the program first for Accredo Specialty Pharmacy customers, investing $100 million through 2028 in the project.
    • “The goal, according to an announcement from the company, is to allow care teams to spend more time on clinical and patient care, while also accelerating prescription processing and service responsiveness.
    • “Patients navigating complex health conditions need comprehensive, expert support, often during some of the most difficult moments in their lives,” said Matt Perlberg, president of the Evernorth Health Services pharmacy and care delivery businesses, including Accredo, and executive vice president of Customer Innovation for The Cigna Group, in the announcement.”
  • Beckers Health IT notes,
    • “Anthropic is launching an internal drug discovery program with a focus on neglected diseases that traditional pharmaceutical companies would not consider commercially attractive, CNBC reported June 30.
    • “At a June 30 event in San Francisco, Eric Kauderer-Abrams, Anthropic’s life sciences head, said the effort is designed to give the company firsthand experience in drug development as it builds AI tools for biopharma customers. Anthropic leaders framed the drug discovery program as a way to build credibility with the biopharma companies it hopes to win as Claude Science customers.
    • “Jonah Cool, Anthropic’s head of life sciences partnerships, said the focus on neglected diseases will run alongside the company’s broader push to create and sell AI tools to life sciences companies.”
  • Genetic Engineering and Biotechnology News adds,
    • “Anthropic has released Claude Science, an AI workbench for scientists that consolidates fragmented research tools, including over 60 scientific databases and connectors pre-configured for genomics, proteomics, structural biology, and more, into a single reasoning layer. The platform joins an increasingly crowded ecosystem of tech platforms specialized for biology and aims to accelerate scientific discovery by making domain expertise more accessible.
    • “Anthropic’s life science partners are delivering applications. Basecamp Research is targeting global public health, where drug-resistant infections play a role in nearly five million deaths per year. The London-based team has announced that its antibiotic design and vaccine target prediction EDEN models will now be available through Claude Science.
    • “A metagenomic foundation model, EDEN demonstrated a 97% success rate when designing functional peptides with high potency against World Health Organization (WHO) critical-priority and multidrug-resistant pathogens. The work was done in collaboration with César de la Fuente, PhD, presidential associate professor at the University of Pennsylvania.”

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.”